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4
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2025
or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to .
Commission File Number 001-38109
MYOMO, INC.
(Exact name of Registrant as Specified in its Charter)
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Delaware |
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47-0944526 |
(State or Other Jurisdiction of |
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(I.R.S. Employer |
Incorporation or Organization) |
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Identification No.) |
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45 Blue Sky Drive, Suite 101, Burlington, MA |
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02114 |
(Address of principal executive offices) |
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(Zip Code) |
(617) 996-9058
Registrant’s Telephone Number, Including Area Code
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock, $0.0001 par value per share |
MYO |
NYSE American |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes: ☒ No: ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
☐ |
|
Accelerated filer |
☐ |
Non-accelerated filer |
☒ |
|
Smaller reporting company |
☒ |
Emerging growth company |
☐ |
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|
|
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
At May 2, 2025, the registrant has 35,978,922 shares of common stock, par value $0.0001 per share, outstanding.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q includes forward-looking statements. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar matters that are not historical facts. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “will” and “would” or the negatives of these terms or other comparable terminology.
You should not place undue reliance on forward looking statements. The cautionary statements set forth in this Quarterly Report on Form 10-Q, including in “Risk Factors” and those contained in our Annual Report on Form 10-K filed with the United States Securities and Exchange Commission on March 10, 2025 and elsewhere, identify important factors which you should consider in evaluating our forward-looking statements. These factors include, among other things:
•our ability to obtain sufficient reimbursement from third-party payers for our products;
•our ability to scale the business to return to positive cash flow from operations on a quarterly basis by the fourth quarter 2025;
•our revenue concentration with Medicare and with a particular insurance payer as a result of focusing our efforts on patients with insurers who have previously reimbursed for the MyoPro;
•our ability to continue normal operations and patient interactions without supply chain disruption in order to deliver and fit our custom-fabricated devices;
•our marketing and commercialization efforts;
•our dependence upon external sources for the financing of our operations, to the extent that we do not achieve or maintain cash flow breakeven;
•our ability to obtain and maintain our strategic collaborations and to realize the intended results of such collaborations;
•our ability to effectively execute our business plan and scale up our operations;
•our ability to remediate the material weakness in our internal control over financial reporting;
•our expectations as to our product development programs, including improving our existing products and developing new products;
•our ability to maintain and grow our reputation and to achieve and maintain the market acceptance of our products;
•our expectations as to our clinical research program and clinical results;
•our ability to maintain adequate protection of our intellectual property and to avoid violation of the intellectual property rights of others;
•our ability to gain and maintain regulatory approvals;
•our ability to compete and succeed in a highly competitive and evolving industry; and
•general market, economic, environmental and social factors that may affect the evaluation, fitting, delivery and sale of our products to patients; and
•other risks and uncertainties, including those listed under the captain “Risk Factors” in this Quarterly Report on Form 10-Q.
Although the forward-looking statements in this Quarterly Report on Form 10-Q and those contained on in our Annual Report on the Form 10-K for the year ended December 31, 2024, are based on our beliefs, assumptions and expectations, taking into account all information currently available to us, we cannot guarantee future transactions, results, performance, achievements or outcomes. No assurance can be made to any investor by anyone that the expectations reflected in our forward-looking statements will be attained, or that deviations from them will not be material and adverse. We undertake no obligation, other than as may be required by law, to re-issue this Quarterly Report on Form 10-Q, or otherwise make public statements updating our forward-looking statements.
Part 1. FINANCIAL INFORMATION
Item 1. Financial statements
MYOMO, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
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March 31, |
|
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December 31, |
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|
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2025 |
|
|
2024 |
|
|
|
(unaudited) |
|
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|
|
ASSETS |
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|
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|
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Current Assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
19,793,799 |
|
|
$ |
24,372,373 |
|
Short-term investments |
|
|
1,730,460 |
|
|
|
492,990 |
|
Accounts receivable, net |
|
|
4,663,398 |
|
|
|
3,825,291 |
|
Inventories, net |
|
|
3,368,502 |
|
|
|
3,165,965 |
|
Prepaid expenses and other current assets |
|
|
1,541,118 |
|
|
|
933,377 |
|
Total Current Assets |
|
|
31,097,277 |
|
|
|
32,789,996 |
|
Restricted Cash |
|
|
375,000 |
|
|
|
375,000 |
|
Operating lease assets with right of use, net |
|
|
7,295,711 |
|
|
|
7,584,663 |
|
Equipment, net |
|
|
1,842,254 |
|
|
|
1,330,008 |
|
Other assets |
|
|
257,085 |
|
|
|
164,412 |
|
Total Assets |
|
$ |
40,867,327 |
|
|
$ |
42,244,079 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
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Current Liabilities: |
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
|
10,448,565 |
|
|
|
9,021,817 |
|
Current operating lease liability |
|
|
765,616 |
|
|
|
748,021 |
|
Income taxes payable |
|
|
331,236 |
|
|
|
318,885 |
|
Deferred revenue |
|
|
129,852 |
|
|
|
83,115 |
|
Total Current Liabilities |
|
|
11,675,269 |
|
|
|
10,171,838 |
|
Non-current operating lease liability |
|
|
7,504,994 |
|
|
|
7,358,184 |
|
Total Liabilities |
|
|
19,180,263 |
|
|
|
17,530,022 |
|
Commitments and Contingencies |
|
|
— |
|
|
|
— |
|
Stockholders’ Equity: |
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Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued or outstanding |
|
|
— |
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— |
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Common stock par value $0.0001 per share, 65,000,000 shares authorized; 34,438,036 and 34,378,297 shares issued as of March 31, 2025 and December 31, 2024, respectively; and 34,438,009 and 34,378,270 shares outstanding at March 31, 2025 and December 31, 2024, respectively |
|
|
3,446 |
|
|
|
3,439 |
|
Additional paid-in capital |
|
|
128,386,223 |
|
|
|
127,846,026 |
|
Accumulated other comprehensive loss |
|
|
(116,545 |
) |
|
|
(14,406 |
) |
Accumulated deficit |
|
|
(106,579,596 |
) |
|
|
(103,114,538 |
) |
Treasury stock, 27 shares at cost |
|
|
(6,464 |
) |
|
|
(6,464 |
) |
Total Stockholders’ Equity |
|
|
21,687,064 |
|
|
|
24,714,057 |
|
Total Liabilities and Stockholders’ Equity |
|
$ |
40,867,327 |
|
|
$ |
42,244,079 |
|
The accompanying notes are an integral part of the condensed consolidated financial statements.
MYOMO, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
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For the Three Months Ended |
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March 31, |
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2025 |
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2024 |
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Revenue |
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|
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|
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Product revenue |
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$ |
9,831,814 |
|
|
$ |
3,754,389 |
|
|
|
|
|
|
|
|
Cost of revenue |
|
|
3,222,184 |
|
|
|
1,455,345 |
|
Gross profit |
|
|
6,609,630 |
|
|
|
2,299,044 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
1,790,024 |
|
|
|
956,215 |
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Selling, clinical and marketing |
|
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4,395,804 |
|
|
|
2,361,845 |
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General and administrative |
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3,944,056 |
|
|
|
2,869,751 |
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|
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10,129,884 |
|
|
|
6,187,811 |
|
|
|
|
|
|
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Loss from operations |
|
|
(3,520,254 |
) |
|
|
(3,888,767 |
) |
|
|
|
|
|
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Other (income) expense, net |
|
|
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|
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|
Interest income, net |
|
|
(191,991 |
) |
|
|
(135,293 |
) |
|
|
|
(191,991 |
) |
|
|
(135,293 |
) |
Loss before income taxes |
|
|
(3,328,263 |
) |
|
|
(3,753,474 |
) |
Income tax expense |
|
|
136,795 |
|
|
|
82,158 |
|
Net loss |
|
$ |
(3,465,058 |
) |
|
$ |
(3,835,632 |
) |
|
|
|
|
|
|
|
|
|
|
|
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|
Weighted average number of common shares outstanding: |
|
|
|
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Basic and diluted |
|
|
41,454,472 |
|
|
|
36,752,597 |
|
Net loss per share attributable to common stockholders |
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.08 |
) |
|
$ |
(0.10 |
) |
The accompanying notes are an integral part of the condensed consolidated financial statements.
MYOMO, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (unaudited)
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|
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|
|
|
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|
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|
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For the Three Months Ended |
|
|
|
March 31, |
|
|
|
2025 |
|
|
2024 |
|
Net loss |
|
$ |
(3,465,058 |
) |
|
$ |
(3,835,632 |
) |
Foreign currency translation adjustments |
|
|
(102,139 |
) |
|
|
63,842 |
|
Other comprehensive (loss) income |
|
|
(102,139 |
) |
|
|
63,842 |
|
Comprehensive loss |
|
$ |
(3,567,197 |
) |
|
$ |
(3,771,790 |
) |
The accompanying notes are an integral part of the condensed consolidated financial statements.
MYOMO, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (unaudited)
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For the Three Month Period Ending March 31, 2025 and 2024 |
|
Common stock |
Additional Paid-in |
Accumulated Comprehensive |
Accumulated |
Treasury Stock |
Total Stockholders’ |
|
Shares |
Amount |
Capital |
(Loss) Income |
Deficit |
Shares |
Amount |
Equity |
Balance, December 31, 2024 |
34,378,297 |
$3,439 |
$127,846,026 |
$(14,406) |
$(103,114,538) |
27 |
$(6,464) |
$24,714,057 |
Common stock issued upon vesting of restricted stock units |
59,031 |
7 |
(7) |
— |
— |
— |
— |
— |
Common stock issued upon vesting of incentive stock options |
708 |
|
|
|
|
|
|
|
Stock-based compensation |
— |
— |
540,204 |
— |
— |
— |
— |
540,204 |
Unrealized loss on foreign currency adjustments |
— |
— |
— |
(102,139) |
— |
— |
— |
(102,139) |
Net loss |
— |
— |
— |
— |
(3,465,058) |
— |
— |
(3,465,058) |
Balance, March 31, 2025 |
34,438,036 |
$3,446 |
$128,386,223 |
$(116,545) |
$(106,579,596) |
27 |
$(6,464) |
$21,687,064 |
|
|
|
|
|
|
|
|
|
Balance, December 31, 2023 |
27,135,061 |
$2,715 |
$105,840,239 |
$83,669 |
$(96,930,809) |
27 |
$(6,464) |
$8,989,350 |
Proceeds from sale of common stock in registered direct offering, net of offering costs of $547,257 |
1,354,218 |
135 |
4,598,636 |
— |
— |
— |
— |
4,598,771 |
Proceeds from sale of 224,730 pre-funded warrants in registered direct offering, net of offering costs of $90,814 |
— |
— |
763,138 |
— |
— |
— |
— |
763,138 |
Common stock issued upon vesting of restricted stock units |
300,544 |
31 |
(31) |
— |
— |
— |
— |
— |
Stock-based compensation |
— |
— |
320,288 |
— |
— |
— |
— |
320,288 |
Unrealized gains on foreign currency adjustments |
— |
— |
— |
63,842 |
— |
— |
— |
63,842 |
Net loss |
— |
— |
— |
— |
(3,835,632) |
— |
— |
(3,835,632) |
Balance, March 31, 2024 |
28,789,823 |
$2,881 |
$111,522,270 |
$147,511 |
$(100,766,441) |
27 |
$(6,464) |
$10,899,757 |
The accompanying notes are an integral part of the consolidated financial statements.
MYOMO, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
2025 |
|
|
2024 |
|
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|
|
|
|
Net loss |
|
$ |
(3,465,058 |
) |
|
$ |
(3,835,632 |
) |
Adjustments to reconcile net loss to net cash used in operations: |
|
|
|
|
|
|
Depreciation |
|
|
158,442 |
|
|
|
29,685 |
|
Stock-based compensation |
|
|
540,204 |
|
|
|
320,288 |
|
Accretion of discount on short-term investments |
|
|
(11,747 |
) |
|
|
(49,053 |
) |
Credit losses |
|
|
51,643 |
|
|
|
— |
|
Amortization of deferred debt origination cost |
|
|
29,039 |
|
|
|
— |
|
Amortization of right-of-use assets |
|
|
288,951 |
|
|
|
58,658 |
|
Other non-cash changes |
|
|
(34,171 |
) |
|
|
63,930 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Accounts receivable |
|
|
(637,054 |
) |
|
|
718,676 |
|
Inventories |
|
|
(550,772 |
) |
|
|
(597,087 |
) |
Prepaid expenses and other current assets |
|
|
(628,186 |
) |
|
|
6,897 |
|
Other assets |
|
|
(70,210 |
) |
|
|
— |
|
Accounts payable and accrued expenses |
|
|
1,440,877 |
|
|
|
87,041 |
|
Operating lease liabilities |
|
|
164,405 |
|
|
|
(115,191 |
) |
Deferred revenue |
|
|
46,738 |
|
|
|
(11,181 |
) |
Income taxes payable |
|
|
— |
|
|
|
77,405 |
|
Net cash used in operating activities |
|
|
(2,676,899 |
) |
|
|
(3,245,564 |
) |
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
Purchases of equipment |
|
|
(670,688 |
) |
|
|
(59,808 |
) |
Maturities of short-term investments |
|
|
— |
|
|
|
2,000,000 |
|
Purchases of short-term investments |
|
|
(1,225,410 |
) |
|
|
(5,482,757 |
) |
Net cash provided by (used in) investing activities |
|
|
(1,896,098 |
) |
|
|
(3,542,565 |
) |
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
Deferred debt origination costs |
|
|
(36,506 |
) |
|
|
— |
|
Net proceeds from common stock offering |
|
|
— |
|
|
|
4,598,771 |
|
Proceeds from sale of pre-funded warrants, net of offering costs |
|
|
— |
|
|
|
763,138 |
|
Net cash (used in) provided by financing activities |
|
|
(36,506 |
) |
|
|
5,361,909 |
|
|
|
|
|
|
|
|
Effect of foreign exchange rate changes on cash |
|
|
30,929 |
|
|
|
(10,360 |
) |
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
(4,578,574 |
) |
|
|
(1,436,580 |
) |
|
|
|
|
|
|
|
Cash and cash equivalents beginning of year |
|
|
24,747,373 |
|
|
|
6,871,306 |
|
|
|
|
|
|
|
|
Cash, cash equivalents and restricted cash end of year |
|
$ |
20,168,799 |
|
|
$ |
5,434,726 |
|
The accompanying notes are an integral part of the condensed consolidated financial statements.
MYOMO, INC.
NOTES TO CONDENSED CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS
Note 1 — Description of Business
Myomo Inc. (“Myomo” or the Company”) is a wearable medical robotics company that develops, designs, and produces myoelectric orthotics for people with neuromuscular disorders. The MyoPro ® myoelectric upper limb orthosis product is registered with the U.S. Food and Drug Administration as a Class II medical device. The Company sells its products directly to patients, to Orthotics and Prosthetics ("O&P") providers around the world, the Veterans Health Administration, and distributors in Europe and Australia. The Company was incorporated in the State of Delaware on September 1, 2004 and is headquartered in Boston, Massachusetts.
Note 2 — Liquidity
The Company incurred net losses of approximately $3,465,100 and $3,835,600 during the three months ended March 31, 2025 and 2024, respectively, and has an accumulated deficit of approximately $106,575,600 and $103,114,500 at March 31, 2025 and December 31, 2024, respectively. Cash used in operating activities was approximately $2,676,900 and $3,245,600 for the three months ended March 31, 2025 and 2024, respectively.
Based upon its current cash, cash equivalents, and short-term investments, as well as the future expected cash flows, the Company believes that its available cash, cash equivalents, and short-term investments will fund its operations for at least the next twelve months from the issuance date of these financial statements.
The Company has historically funded its operations through financing activities, including raising equity and debt. On December 6, 2024, the Company completed a public offering, selling 3,450,000 shares of common stock at $5.00 per share, generating net proceeds after taxes and fees of approximately $15.8 million. On January 19, 2024, the Company completed a registered direct equity offering, selling 1,354,218 shares of common stock and 224,730 pre-funded warrants to purchase common stock at $3.80 per share, or $3.7999 per pre-funded warrant, generating net proceeds after fees and expenses of approximately $5.4 million. See Note 7 - Common Stock and Warrants for further discussion. On July 11, 2024, the Company entered into a Loan and Security Agreement with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (“Silicon Valley Bank”), which provides the ability to borrow up to $4.0 million against eligible accounts receivable. In February 2025, the Company entered into an amendment to the Loan and Security Agreement, which among other changes, provides for a $3.0 million term loan facility which is available to be drawn at any time before February 28, 2026. The line of credit and term loan each remain undrawn as of the issuance date of these financial statements. Availability under the line of credit is approximately $216,600 based on eligible accounts receivable as of March 31, 2025. Financing activities, such as the recent public offering, have enabled the Company to sustain its operations.
Management's operating plans are primarily focused on growing revenues in its direct billing channel, while working to grow revenues in its O&P channel. These plans include increasing advertising spending and adding headcount to support growth in its clinical, reimbursement, and manufacturing capacity in order to serve a higher volume of patients in 2025. These investments are expected to result in negative cash flows for at least the first three quarters of 2025. In addition, the Company believes that it has access to capital resources through possible public or private equity offerings, debt financings, or other means. Debt financing may contain other terms that are not favorable to the Company or its stockholders.
Note 3 — Summary of Significant Accounting Policies
Interim Financial Statements
The accompanying unaudited condensed consolidated financial statements and notes are representations of the Company’s management, who are responsible for their integrity and objectivity. These statements have been prepared in accordance with United States generally accepted accounting principles ("U.S. GAAP") for interim financial information pursuant to Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for annual financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) that are considered necessary for a fair presentation of the condensed consolidated financial statements of the Company as of March 31, 2025 and for the three months ended March 31, 2025 and 2024. The results of operations for the three months ended March 31, 2025 are not necessarily indicative of the operating results for the fiscal year ending December 31, 2025, or any other period. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related disclosures of the Company as of December 31, 2024 and 2023 and for the years then ended, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.
Basis of Consolidation
The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary Myomo Europe GmbH. All significant intercompany balances and transactions are eliminated.
Comprehensive Income (Loss)
Comprehensive loss includes all changes in equity during a period, except those resulting from investments by stockholders and distributions to stockholders. The Company's comprehensive loss includes changes in foreign currency translation adjustments and unrealized gains and losses on short term investments. There was a reclassification which management does not consider to be material out of accumulated other comprehensive income (loss) to other (income) expense related to realized gains or losses on short-term investments in the three months ended March 31, 2025. There were no reclassifications in the three months ended March 31, 2024.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America require management to make estimates and assumptions that affect certain reported amounts and disclosures. These estimates and assumptions are reviewed on an on-going basis and updated as appropriate. Actual results could differ from these estimates. The Company’s estimates include assertion of collectability with payers where the Company has no contracts as it relates to timing of revenue recognition and discount rate of leases.
Cash, Cash Equivalents and Short-Term Investments
The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents consist principally of deposit accounts and money market accounts at March 31, 2025 and December 31, 2024.
The Company considers all investments with an original maturity of greater than three months but less than one year to be short-term investments. Short-term investments as of March 31, 2025 and December 31, 2024 consists of U.S. Treasury Bills and U.S. Government Agency Bills, which are classified as held-to-maturity, totaling approximately $1,760,500 and $493,000 as of March 31, 2025, and December 31, 2024, respectively. The Company determines the appropriate balance sheet classification of its investments at the time of purchases and evaluates the classification at each balance sheet date. All of the Company's U.S. Treasury Bills mature within the subsequent twelve months from the date of purchase.
The Company’s cash balances as of March 31, 2025 and December 31, 2024 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
Cash and cash equivalents |
|
$ |
19,793,799 |
|
|
$ |
24,372,373 |
|
Restricted cash |
|
|
375,000 |
|
|
|
375,000 |
|
Total cash, cash equivalents, and restricted cash |
|
$ |
20,168,799 |
|
|
$ |
24,747,373 |
|
Accounts Receivable and Allowance for Credit Losses
The Company reports accounts receivable at invoiced amounts less an allowance for credit losses accounts. The Company evaluates its accounts receivable on a continuous basis and, if necessary, establishes an allowance for credit losses based on a number of factors, including current credit conditions and customer payment history. The Company does not require collateral or accrue interest on accounts receivable and credit terms are generally 30 days. At March 31, 2025, and December 31, 2024, the Company recorded an allowance for credit losses accounts of approximately $107,900 and $56,300, respectively.
Revenue Recognition
The Company accounts for revenue under ASC 606, “Revenue from Contracts with Customers” and all of the related amendments (Topic 606). Revenues under Topic 606 are required to be recognized either at a “point in time” or “over time,” depending on the facts and circumstances of the arrangement and are evaluated using a five-step model. Generally, the Company recognizes revenue at a point in time.
The Company recognizes revenue after applying the following five steps:
1)Identification of the contract, or contracts, with a customer,
2)Identification of the performance obligations in the contract, including whether they are distinct within the context of the contract,
3)Determination of the transaction price, including the constraint on variable consideration,
4)Allocation of the transaction price to the performance obligations in the contract, and
5)Recognition of revenue when, or as, performance obligations are satisfied.
Revenue is recognized when control of these services is transferred to our customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those services.
Product Revenue
Increasingly, the Company derives its revenue from direct billing. The Company also derives revenue from the sale of its products to O&P providers in the United States and internationally and the Veterans Administration (“VA”). Under direct billing, the Company recognizes revenue when all of the following criteria are met:
(i)The product has been delivered to the patient, including completion of initial instruction on its use,
(ii)Collection is deemed probable and it has been determined that a significant reversal of the revenue to be recognized is not deemed probable when the uncertainty associated with the variable consideration is resolved. As an example, the Company will record revenue if it is notified that insurance intends to pay and a payment amount is provided, and
(iii)The amount to be collected is estimable using the “expected value” estimation techniques, or the “most likely amount” as defined in ASC 606.
For revenue derived from patients with Medicare Part B, the Company recognizes revenue upon delivery of the device to the patient based on the published fees by the Centers for Medicare & Medicaid Services ("CMS"). With respect to patients with Medicare Advantage or other commercial insurance, for payers where the Company either has a contract or in the absence of a contract, has demonstrated sufficient payment history, the Company will recognize revenue when it receives a pre-authorization from the insurance company and control passes to the patient upon delivery of the device in an amount that reflects the consideration the Company expects to receive in exchange for the device. During the three months ended March 31, 2025 and 2024, the Company made such a determination for certain insurers. These insurers represented approximately 13% and 54% of direct billing channel revenue for the three months ended March 31, 2025 and 2024, respectively. In cases where the Company is the direct provider and it does not have sufficient collection history with the payer, the Company recognizes revenue when payment is received, as then all of the revenue recognition criteria have been met.
Depending on the timing of product deliveries to customers, which is when cost of revenue must be recorded, and when the Company meets the criteria to record revenue, there may be fluctuations in gross margin. During the three months ended March 31, 2025 and 2024, the Company recognized revenue of approximately $836,100 and $963,400, respectively, from third-party payers for which costs related to the completion of the Company’s performance obligations were not recorded in the current period.
For revenues derived from O&P providers and the VA, the Company recognizes revenue when control passes to the customer in an amount that reflects the consideration the Company expects to receive in exchange for those services. Revenues may be recognized upon shipment or upon delivery, depending on the terms of the arrangement, provided that persuasive evidence of an arrangement exists, there are no uncertainties regarding customer acceptance and collectability is deemed probable.
The Company has elected to record taxes collected from customers on a net basis and does not include tax amounts in revenue or cost of revenue.
Contract Balances
The timing of revenue recognition may differ from the timing of payment by customers. The Company records a receivable when revenue is recognized prior to payment and there is an unconditional right to payment. Alternatively, when payment precedes the provision of the related services, the Company records deferred revenue until the performance obligations are satisfied. The Company had deferred revenue of approximately $129,900 and $83,100 as of March 31, 2025 and December 31, 2024, respectively.
Disaggregated Revenue from Contracts with Customers
The following table presents revenue by major source:
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
2025 |
|
|
2024 |
|
Direct to patient |
|
$ |
7,807,777 |
|
|
$ |
2,234,742 |
|
Clinical/Medical providers |
|
|
2,024,037 |
|
|
|
1,519,647 |
|
Total revenue from contracts with customers |
|
$ |
9,831,814 |
|
|
$ |
3,754,389 |
|
Geographic Data
The Company generated 87% of its total revenue from the United States, 13% from Germany, and less than 1% from other international locations for the three months ended March 31, 2025. The Company generated 75% of its total revenue from the United States, 22% from Germany, and 3% from other international locations, for the three months ended March 31, 2024.
Cost of Revenue
In conjunction with the adoption of ASC 606, there are certain cases in which the Company will expense costs when incurred as required by ASC 340-40-25. In certain cases, the Company provides the MyoPro device directly to patients, pending reimbursement from third-party payers, after which revenue is recognized. For the three months ended March 31, 2025 and 2024, the Company recorded cost of goods sold of approximately $32,400 and $112,100, respectively, without corresponding revenue. Direct billing fees paid to O&P providers for services they provide in conjunction with patient evaluations are expensed as incurred as required by ASC 340-40-25. These costs are recorded as sales and marketing expense. Internal costs incurred and fees paid to O&P providers to measure, fit and deliver the device to patients are expensed to cost of revenue.
Advertising
The Company charges the costs of advertising to operating expenses as incurred. Advertising expense amounted to approximately $1,609,700 and $787,200 during the three months ended March 31, 2025 and 2024, respectively.
Foreign Currency Translation
The functional currency of the Company’s foreign subsidiary, Myomo Europe GmbH, is the Euro. Foreign exchange translation gains and losses from the Euro to U.S. dollars are included in other comprehensive gain. The Company recorded a comprehensive loss of approximately $102,100 and comprehensive income of approximately $63,800 during the three months ended March 31, 2025 and 2024, respectively, which are included in accumulated other comprehensive loss in the condensed consolidated balance sheet. Transaction and translation foreign exchange gains and losses from a foreign currency to the functional currency are included in cost of revenue in the condensed consolidated statements of operations. Such amounts were immaterial for the three months ended March 31, 2025 and 2024. The balance sheet is translated using the spot rate on the day of reporting and the statement of operations is translated monthly using the average rate for the month.
Net Loss per Share
Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding, plus potentially dilutive common shares. Restricted stock, restricted stock units, stock options and warrants are excluded from the diluted net loss per share calculation when their impact is antidilutive. The Company reported a net loss for the three months ended March 31, 2025 and 2024, and as a result, all potentially dilutive common shares are considered antidilutive for these periods.
Potential dilutive common shares issuable consist of the following at:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
2025 |
|
|
2024 |
|
Stock options |
|
|
22,383 |
|
|
|
23,929 |
|
Restricted stock units |
|
|
1,190,511 |
|
|
|
1,197,626 |
|
Other warrants |
|
|
— |
|
|
|
668,250 |
|
Total |
|
|
1,212,894 |
|
|
|
1,889,805 |
|
Due to their nominal exercise price of $0.0001 per share, a total of 7,061,519 and 8,496,249 outstanding pre-funded warrants as of March 31, 2025 and 2024, respectively, are considered common stock equivalents and are included in weighted average shares outstanding in the accompanying condensed consolidated statements of operations as of the respective closing dates of the Company's public equity offerings.
Recently Adopted Accounting Standards
In October 2023, the FASB issued ASU 2023-06, “Disclosure Improvements, Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative”, that adds 14 of the 27 identified disclosure or presentation requirements to the Codification, each amendment in the ASU will only become effective if the SEC removes the related disclosure or presentation from its existing regulations by
June 30, 2027. The Company currently complies with these disclosure requirements as applicable under Regulation S-X or Regulation S-K and will adopt these new standards depending on timing of when they become effective, which is not expected to have a material impact on its financial position and results of operations.
In December 2023, the FASB issued ASU 2023-09, “Accounting Standards Update, Income Taxes (Topic 740: Improvements to Income Tax Disclosures”. ASU 2023-09 focuses on income tax disclosures around effective tax rates and cash income taxes paid. This amendment in the ASU will become effective for public companies as of December 15, 2024 and effective to all other companies as of December 15, 2025. The Company will adopt these new standards when they become effective, which is not expected to have a material impact on its financial position and results of operations.
Note 4 — Inventories
Inventories consist of the following at:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
Finished goods |
|
$ |
1,294,662 |
|
|
$ |
1,289,368 |
|
Work in process |
|
|
98,518 |
|
|
|
60,731 |
|
Parts and subassemblies |
|
|
1,975,322 |
|
|
|
1,815,866 |
|
Inventories, net |
|
$ |
3,368,502 |
|
|
$ |
3,165,965 |
|
Note 5 — Fair Value of Financial Instruments
The Company measures the fair value of financial assets and liabilities based on the guidance of ASC 820, “Fair Value Measurement” (“ASC 820”), which defines fair value, establishes a framework for measuring fair value, and establishes disclosures about fair value measurements.
ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:
•Level 1 — Quoted prices available in active markets for identical assets or liabilities.
•Level 2 — Observable inputs other than quoted prices included in Level 1, such as quotable prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data.
•Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant unobservable inputs.
The carrying amounts of the Company’s financial instruments such as cash and cash equivalents, accounts receivable and accounts payable, approximate fair value due to the short-term nature of these instruments. Cash equivalents consist of money market funds that limit their investments to only short-term U.S. Treasury Securities and repurchase agreements related to these securities. Short-term investments primarily consists of commercial paper and U.S. Treasury Bills and are carried on the condensed consolidated balance sheets at amortized cost which approximates fair value.
Cash equivalents and short-term investments measured at fair value on a recurring basis at March 31, 2025 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In Active Markets for Identical Assets or Liabilities (Level 1) |
|
|
Significant Other Observable Inputs (Level 2) |
|
|
Significant Unobservable Inputs (Level 3) |
|
|
Total |
|
Money market funds |
|
$ |
18,359,786 |
|
|
|
— |
|
|
|
— |
|
|
$ |
18,359,786 |
|
Short-term investments |
|
$ |
— |
|
|
$ |
1,730,460 |
|
|
$ |
— |
|
|
$ |
1,730,460 |
|
Cash equivalents and short-term investments measured at fair value on a recurring basis at December 31, 2024 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In Active Markets for Identical Assets or Liabilities (Level 1) |
|
|
Significant Other Observable Inputs (Level 2) |
|
|
Significant Unobservable Inputs (Level 3) |
|
|
Total |
|
Money market funds |
|
$ |
23,334,374 |
|
|
|
— |
|
|
|
— |
|
|
$ |
23,334,374 |
|
Short-term investments |
|
|
— |
|
|
$ |
492,990 |
|
|
|
— |
|
|
$ |
492,990 |
|
Note 6 - Accounts Payable and Other Accrued Expenses
Accounts Payable and Other Accrued Expenses consists of the following at:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
Trade payables |
|
$ |
2,488,829 |
|
|
$ |
1,169,901 |
|
Accrued compensation and benefits |
|
|
4,830,562 |
|
|
|
5,009,385 |
|
Accrued professional services |
|
|
109,844 |
|
|
|
54,257 |
|
Warranty reserve |
|
|
139,409 |
|
|
|
129,615 |
|
Customer deposits |
|
|
2,774,665 |
|
|
|
2,194,804 |
|
Accrued insurance |
|
|
— |
|
|
|
128,556 |
|
Other |
|
|
105,256 |
|
|
|
335,299 |
|
|
|
$ |
10,448,565 |
|
|
$ |
9,021,817 |
|
Note 7 — Common Stock and Warrants
On December 6, 2024, the Company completed a public equity offering, selling 3,450,000 shares of common stock at $5.00 per share, generating net proceeds after fees and expenses of approximately $15.8 million.
On January 19, 2024, the Company completed a registered direct equity offering, selling 1,354,218 shares of common stock and 224,730 pre-funded warrants at $3.80 per share, or at $3.7999 per pre-funded warrant, generating proceeds after fees and expenses of approximately $5.4 million. Each pre-funded warrant is exercisable for one share of the Company’s common stock at a nominal exercise price of $0.0001 per share.
As of March 31, 2025, 7,061,519 pre-funded warrants remain exercisable. Each pre-funded warrant is exercisable for one share of the Company’s common stock at a nominal exercise price of $0.0001 per share.
No pre-funded warrants were exercised during the three months ended March 31, 2025 and 2024, respectively.
During the three months ended March 31, 2025, 668,250 investor warrants issued in the Company’s public offering in February 2020 expired unexercised.
708 shares of common stock were issued through the exercise of stock options during the three months ended March 31, 2025 and none during the three months ended March 31, 2024.
During the three months ended March 31, 2025 and 2024, 59,031 and 300,544 restricted stock units vested, respectively.
Note 8 — Line of Credit
On July 11, 2024 (the “Effective Date”), the Company, entered into a Loan and Security Agreement (the “Loan Agreement”) with Silicon Valley Bank.
The Loan Agreement provides for a revolving line of credit whereby the Company may borrow up to $4,000,000 (the “Revolving Line”), which Revolving Line may be increased to $5,500,000 at Silicon Valley Bank’s sole discretion upon the occurrence of certain events. Amounts advanced by Silicon Valley Bank are based on 80% of “eligible accounts”, which includes all receivables in the United States, reduced by aged amounts and customers and insurance payers with concentrations in excess of defined limits, among other deductions. The outstanding principal amount of any advance shall accrue interest at a floating rate per annum equal to the greater of (i) 8.50% and (ii) the “prime rate” as published in The Wall Street Journal for the relevant period plus one-half percent (0.50%). The Revolving Line is secured on a first priority basis by all of Company’s assets other than intellectual property and certain customary exceptions. Any newly formed or acquired subsidiary of the Company or any guarantor under the Loan Agreement, will either join the Loan Agreement as a co-borrower or become a guarantor under the Loan Agreement, as determined by Silicon Valley Bank in its sole discretion. The Company intends to use the Revolving Line for working capital and general business purposes.
The Revolving Line terminates, and any outstanding principal amount of all advances made thereunder, and any accrued and unpaid interest thereon, become immediately due and payable on the two year anniversary of the Effective Date. The Company must also pay Bank (i) a commitment fee of $20,000, (ii) an “Anniversary Fee” of 0.50% of the Revolving Line and (iii) an “Unused Revolving Line Facility Fee” of 0.50% per annum of the average unused portion of the Revolving Line. In addition, upon termination of the Loan Agreement or the Revolving Line prior to the two year anniversary of the Effective Date, the Company must pay a termination fee of 1.00% of the Revolving Line, subject to certain exceptions.
On February 18, 2025, the Company entered into a First Amendment (the “Amendment”) to the Loan Agreement. The Amendment provides for, among other things, a new term loan facility (the “Term Loan”) to the Company of up to $3,000,000, available to the Company until February 28, 2026. Advances under the Term Loan (collectively, the “Term Loan Advances”) will be payable in 36 equal monthly installments of principal plus interest, commencing on March 1, 2026, and to the extent not paid, all remaining obligations will become due and payable on February 1, 2029. Term Loan Advances shall accrue interest at a floating rate per annum equal to the greater of (a) 5.0% or (b) the “prime rate,” as published from time to time in the money rates section of the Wall Street Journal, minus 1.0%. At the Company’s option, the Company may prepay all outstanding borrowings under the Term Loan, plus accrued and unpaid interest thereon, subject to a prepayment premium ranging from 1.0% to 3.0%, depending on the year of prepayment. The Term Loan also provides for an end of term charge equal to 2.50% of the aggregate principal amount of any loans prepaid or repaid, as applicable.
The Amendment also makes certain changes to the Company’s revolving line of credit under the Loan Agreement, including (i) increasing the defined limit for concentration of Medicare receivables that may be included as “eligible accounts” under the Loan Agreement, and (ii) increasing the permitted aggregate maximum balance that may be maintained in the Company’s German subsidiary.
The Company recorded approximately $199,500 in debt origination costs during the year ended December 31, 2024 in conjunction with entering into the Loan Agreement, which includes the commitment fee and the Anniversary Fee. The Company capitalized the debt origination costs and is amortizing them into interest expense using the interest rate method, which approximates straight-line amortization over the term of the Loan Agreement. As of March 31, 2025, the balance of debt origination costs was approximately $165,400, which is included in other long-term assets on the condensed consolidated balance sheet. The Company amortized approximately $29,000 of debt origination costs to interest expense during the three months ended March 31, 2025.
Approximately $216,600 was available to be drawn under the Loan Agreement based on eligible accounts receivable as of March 31, 2025. No amounts were drawn under the Revolving Line or the Term Loan under the Loan Agreement as of March 31, 2025.
Note 9 — Stock Award Plans and Stock-Based Compensation
As of March 31, 2025, there were 1,819,933 shares available for issuance under the Myomo, Inc. 2018 Stock Option and Incentive Plan (the “2018 Plan”). On January 1 of each year, the number of shares of common stock reserved and available for issuance under the 2018 Plan will cumulatively increase by 4% of the number shares of common stock outstanding on the immediately preceding December 31 or such lesser number of shares of common stock determined by management in consultation with members of the Board of Directors, including the compensation committee of the Board of Directors. On January 1, 2025, 1,375,130 shares were added to the share reserve under the 2018 Plan.
Recipients of awards of restricted stock units typically sell shares in the open market to cover their individual tax liabilities and remit the proceeds to the Company, which offsets withholding taxes paid by the Company. In certain circumstances, stock awards may be net share settled upon vesting to cover the required employee statutory withholding taxes and the remaining amount is converted into shares based upon their share-value on the date the award vests. In such instances, these payments of employee withholding taxes are presented in the statements of cash flows as a financing activity. There were no stock awards that were net share settled during the three months ended March 31, 2025 and 2024, respectively.
Share-Based Compensation Expense
The Company accounts for stock awards to employees and non-employees based upon the fair value of the award on the date of grant. The fair value of that award is then ratably recognized as expense over the period during which the recipient is required to provide services in exchange for that award.
The Company attributes the value of stock-based compensation to operations on the straight-line method such that the expense associated with awards is evenly recognized over the vesting period.
The Company recognized stock-based compensation expense related to the issuance of stock option awards and restricted stock units to employees, non-employees and directors in the statements of operations as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2025 |
|
|
2024 |
|
Cost of goods sold |
|
$ |
41,718 |
|
|
$ |
23,387 |
|
Research and development |
|
|
78,155 |
|
|
|
24,245 |
|
Selling, clinical, and marketing |
|
|
80,239 |
|
|
|
46,121 |
|
General and administrative |
|
|
340,092 |
|
|
|
226,535 |
|
Total |
|
$ |
540,204 |
|
|
$ |
320,288 |
|
As of March 31, 2025, there was approximately $2,900 of unrecognized compensation cost related to unvested stock options that is expected to be recognized over a weighted-average period of 0.48 years.
As of March 31, 2025, there was approximately $1,944,000 of unrecognized compensation expense related to unvested restricted stock units that is expected to be recognized over a weighted-average period of 2.20 years.
Note 10 — Commitments and Contingencies
Litigation
The Company may be involved from time to time in legal proceedings, claims and assessments arising from the ordinary course of business. Such matters are subject to many uncertainties, and outcomes are not predictable with assurance. There are no material claims, assessments or litigation against the Company as of March 31, 2025.
Operating Leases
The Company had a lease agreement for its corporate headquarters in Boston, Massachusetts, which expired in January 2025 and has a lease agreement for office space in Fort Worth, TX. which expires in December 2025. In August 2024, the Company entered into a lease agreement for a new corporate headquarters and manufacturing facility in Burlington, Massachusetts. The Company began relocating operations in December 2024 and completed the move in January 2025. The term of the lease is 88 months following the rent commencement date, which will be May 11, 2025. The Company has the option to extend the new lease for an additional five years, subject to certain conditions being satisfied. Under the new lease, the Company provided a security deposit to the landlord in the form of a letter of credit for $375,000. The Company has collateralized the letter of credit with cash in a separate bank account, which is accounted for as long-term restricted cash on the condensed consolidated balance sheet. Termination options are either not included, or have expired, for the Company’s other existing operating leases. Certain arrangements have discounted rent periods or escalating rent payment provisions. Leases with an initial term of twelve months or less are not recorded on the consolidated balance sheets. We recognize rent expense on a straight-line basis over the lease term.
As of March 31, 2025, operating lease assets were approximately $7,295,700. The amount and the maturity of the Company’s operating lease liabilities as of March 31, 2025, are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
2025 |
|
|
|
|
|
|
|
$ |
622,094 |
|
2026 |
|
|
|
|
|
|
|
|
1,168,752 |
|
2027 |
|
|
|
|
|
|
|
|
1,522,500 |
|
2028 |
|
|
|
|
|
|
|
|
1,584,678 |
|
Thereafter |
|
|
|
|
|
|
|
|
6,511,404 |
|
Total future minimum lease payments |
|
|
|
|
|
|
|
|
11,409,428 |
|
Less imputed interest |
|
|
|
|
|
|
|
|
3,138,818 |
|
Total operating lease liabilities |
|
|
|
|
|
|
|
$ |
8,270,610 |
|
Included in the condensed consolidated balance sheet: |
|
|
|
|
|
|
|
|
|
Current operating lease liabilities |
|
|
|
|
|
|
|
$ |
765,616 |
|
Non-current operating lease liabilities |
|
|
|
|
|
|
|
|
7,504,994 |
|
Total operating lease liabilities |
|
|
|
|
|
|
|
$ |
8,270,610 |
|
For the three months ended March 31, 2025 and 2024, the total lease cost is comprised of the following amounts:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
|
|
|
|
2025 |
|
|
2024 |
|
Operating lease expense |
|
|
|
|
|
$ |
401,809 |
|
|
$ |
89,496 |
|
Short-term lease expense |
|
|
|
|
|
|
1,722 |
|
|
|
- |
|
Total lease expense |
|
|
|
|
|
$ |
403,531 |
|
|
$ |
89,496 |
|
The following summarizes additional information related to operating leases:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
Weighted-average remaining lease term (in years) |
|
|
|
|
|
|
7.6 |
|
|
|
7.8 |
|
Weighted-average discount rate |
|
|
|
|
|
|
8.6 |
% |
|
|
8.6 |
% |
Supplier Finance Program Obligations
The Company finances its directors and officers insurance policy, which requires the Company to make a down payment, followed by equal payments over a defined term. During the year ended December 31, 2023, the Company entered into a policy covering the twelve-month period ending June 2024. Under this financing arrangement, the Company made nine equal monthly payments of approximately $27,000, starting in July 2023. During the year ended December 31, 2024, the Company completed its payment obligation associated with its 2023-2024 policy and entered into a new policy covering the twelve-month period ending in June 2025. Under this new financing arrangement, the Company made a down payment of approximately $39,000 during the three months ended June 30, 2024, and is making nine equal monthly payments of approximately $39,000, starting in July 2024. Changes in the Company's supplier finance obligations were as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2025 |
|
|
2024 |
|
Opening January 1 |
|
$ |
181,256 |
|
|
$ |
142,217 |
|
Payments |
|
|
— |
|
|
|
— |
|
Expensed |
|
|
98,508 |
|
|
|
80,109 |
|
Ending |
|
$ |
82,748 |
|
|
$ |
62,108 |
|
No assets are pledged as security under this arrangement.
Note 11 — Segment Reporting and Major Customers
Segment Reporting
ACS 280, “Segment Reporting” establishes standards for reporting information about operating segments on a basis consistent with the Company’s internal organization structure as well as information about products, business segments, and major customers in financial statements. The Company conducts its business in one operating segment, and sells products in one family, which are versions of the MyoPro. While the Company has several sales channels and operates in different geographies, the Chief Executive Officer, who is the Company's chief operating decision-maker, and is responsible for allocating resources and assessing the performance of the Company, manages the Company's business on a consolidated basis, focusing on revenue, gross margin, certain operating expenses, loss from operations, other expenses (income), Income Tax, and Net loss. The Chief Executive Officer reviews the consolidated balance sheet with relation to consolidated Assets. The Chief Executive Officer does not review any additional or more disaggregated level.
|
|
|
|
|
|
|
|
|
For the three months ended March 31, |
|
2025 |
|
|
2024 |
|
Revenue |
|
|
|
|
|
|
Product Revenue |
|
$ |
9,831,814 |
|
|
$ |
3,754,389 |
|
|
|
|
9,831,814 |
|
|
|
3,754,389 |
|
|
|
|
|
|
|
|
Cost of revenue |
|
|
3,222,184 |
|
|
|
1,455,345 |
|
Gross profit |
|
|
6,609,630 |
|
|
|
2,299,044 |
|
Gross margin |
|
|
67.2 |
% |
|
|
61.2 |
% |
Operating expenses: |
|
|
|
|
|
|
Payroll and benefits expense |
|
|
5,257,082 |
|
|
|
3,441,559 |
|
Advertising |
|
|
1,609,688 |
|
|
|
787,250 |
|
All other segment operating expenses |
|
|
4,488,315 |
|
|
|
2,565,432 |
|
Payroll and benefits expense in cost of revenue |
|
|
(1,225,201 |
) |
|
|
(606,430 |
) |
|
|
|
10,129,884 |
|
|
|
6,187,811 |
|
Loss from operations |
|
$ |
(3,520,254 |
) |
|
$ |
(3,888,767 |
) |
Other expense (income) |
|
|
(191,991 |
) |
|
|
(135,293 |
) |
Income Tax Expense |
|
|
136,795 |
|
|
|
82,158 |
|
Net Loss |
|
$ |
(3,465,058 |
) |
|
$ |
(3,835,632 |
) |
Major Customers
For the three months ended March 31, 2025 and 2024, there were no customers which accounted for more than 10% of product revenues. For the three months ended March 31, 2025, CMS represented 59% of product revenues. For the three months ended March 31, 2024, a U.S. insurance payer represented 32% of product revenues.
At March 31, 2025, CMS and a U.S. commercial insurer and its affiliates accounted for approximately 46% and 12% of accounts receivable, respectively. At December 31, 2024, CMS and a U.S. commercial insurer and its affiliates accounted for approximately 36% and 19% of accounts receivable, respectively.
For the three months ended March 31, 2025 and 2024, approximately 17% and 38% of the Company's product revenues, respectively, were derived from patients with Medicare Advantage insurance plans.
Note 12 — Subsequent Events
The Company evaluated subsequent events through the date the financial statements were issued, and determined that there have been no subsequent events that would require recognition in the financial statements or disclosure in the notes to the unaudited condensed consolidated financial statements.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion should be read in conjunction with our condensed consolidated financial statements and the related notes contained elsewhere in this Quarterly Report on Form 10-Q and in our other Securities and Exchange Commission filings. The following discussion may contain predictions, estimates, and other forward-looking statements that involve a number of risks and uncertainties, including those discussed under “Risk Factors”, “Cautionary Statement Regarding Forward-Looking Statements” and elsewhere in this Quarterly Report on Form 10-Q and those described under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024. These risks could cause our actual results to differ materially from any future performance suggested below.
Overview
We are a wearable medical robotics company, specializing in myoelectric braces, or orthotics, for people with neuromuscular disorders. We develop and market the MyoPro product line, which is a myoelectric-controlled upper limb brace, or orthosis. The orthosis is a rigid brace used for the purpose of supporting a patient’s weak or deformed arm to enable and improve functional activities of daily living, (“ADLs”) in the home and community. It is custom constructed by a trained professional during a custom fabrication process for each individual user to meet their specific needs. Our products are designed to help regain function in individuals with neuromuscular conditions due to brachial plexus injury, stroke, traumatic brain injury, spinal cord injury and other neurological disorders.
We utilize digital ads on various platforms as well as television ads to reach patients who are potential candidates for our product. Once the prospective patient contacts us or is referred to us, either our trained clinical staff or a trained Orthotics and Prosthetics (“O&P”) provider will evaluate the patient for their suitability as a candidate. Initial evaluations by our trained clinical staff are often conducted using telehealth techniques, followed by an in-person clinical evaluation of the candidate. Prior to obtaining authorizations from commercial insurance companies, the patient’s medical records are collected and reviewed to make sure the device is appropriate for their condition and a prescription is always obtained from a physician. Once these documents are obtained, a pre-authorization request is submitted to the patient’s insurer. If we receive a pre-authorization, we proceed to measure the patient’s arm. If the patient is covered by Medicare Part B, no pre-authorization is required and we can move directly to taking measurements of the patient's arm. This is done either in person, or in some cases using a digital measurement kit supplied to the patient. We then use those measurements to 3D print orthotic parts, which are used to fabricate the MyoPro, and then deliver it to the patient. Since we are directly providing the device to the patient and then billing insurance ourselves, we refer to this process as direct billing. We also call on O&P practices in the United States, Europe and Australia that provide our products to their patients as well as generate indirect sales. The MyoPro product line has been approved by the Veterans Administration (“VA”) for impaired veterans, and over 100 VA facilities have ordered devices for their patients.
Our myoelectric orthoses have been clinically shown in peer reviewed published research studies to help regain the ability to complete functional tasks by supporting the affected joint and enabling individuals to self-initiate and control movement of their partially paralyzed limbs by using their own muscle signals. Our technology was originally developed at MIT in collaboration with medical experts affiliated with Harvard Medical School. Myomo was incorporated in 2004.
Other historical milestones include:
•In 2012, we introduced the MyoPro. The primary business focus shifted from developing devices that were designed for rehabilitation therapy and sold to hospitals to providing an assistive device through O&P providers to patients who are otherwise impaired for use at home, work, and in the community that facilitates ADLs.
•During 2015, we extended our basic MyoPro for the elbow with the introduction of the MyoPro Motion W, a multi-articulated non-powered wrist and the MyoPro Motion G, which includes a powered grasp. The MyoPro Motion W allows the user to use their sound arm to adjust the device and then, for instance, open a refrigerator door, carry a shopping bag, hold a cell phone, or stabilize themselves to avoid a fall and potential injury. The MyoPro Motion G model allows users with severely weakened or clenched hands, such as seen in certain stroke survivors, to open and close their hands and perform a large number of ADLs.
•On June 9, 2017, we completed our initial public offering (“IPO”) and a private offering concurrent with the IPO, generating net proceeds of $6.9 million in the aggregate.
•On July 31, 2017, we met the criteria to apply the CE Mark for the MyoPro. This has enabled us to sell the MyoPro to individuals in the European Union (the “EU”).
•In November 2018, we announced that the Centers for Medicare and Medicaid Services, (“CMS”), had published two new codes (L8701, L8702) pursuant to our application for Healthcare Common Procedure Coding System (“HCPCS”) codes which become effective in early 2019.
•In 2019, we transitioned our business to become a direct provider of the MyoPro to patients and bill insurance companies directly.
•In July 2021, we became accredited as a Medicare provider.
•In January 2022, we introduced MyoPro 2+ and began in-house fabrication of the device.
•On November 1, 2023, CMS issued a final rule that resulted in a change in the benefit category associated with products billed under the HCPCS codes for our products from durable medical equipment rental to a brace, which would permit reimbursement of MyoPro sales on a lump sum basis. The rule became effective on January 1, 2024.
•On February 29, 2024, CMS published final payment determinations for the HCPCS codes describing our products which are L8701, for the MyoPro Motion W, and L8702, for the MyoPro Motion G, which became effective on April 1, 2024. These fees were subsequently updated to approximately $34,300 for the Motion W and approximately $67,500 for the Motion G, effective January 1, 2025. These fees are subject to annual inflationary adjustments.
Recent Developments
Equity Offerings
On December 6, 2024, we completed a public offering, selling 3,450,000 shares of common stock at $5.00 per share, generating net proceeds after fees and expenses of approximately $15.8 million. Net proceeds from the offering are expected to be used to grow revenues in our direct billing channel through additional advertising spending and the addition of clinical, reimbursement and manufacturing headcount to support expected increasing demand, to increase R&D spending in order to accelerate the completion of sustaining and new product development activities, to fund systems and headcount to support growth in the O&P channel, to fund associated working capital requirements and general corporate purposes. On January 19, 2024 we completed a registered direct equity offering, selling 1,354,218 shares of common stock and 224,730 pre-funded warrants at $3.80 per share, or $3.7999 per pre-funded warrant, generating net proceeds after fees and expenses of approximately $5.4 million. Each pre-funded warrant in the above offering entitles the holder to one share of common stock upon exercise at a nominal exercise price of $0.0001 per share. See section titled “Liquidity” for further discussion.
Results of Operations
We have been growing revenues while incurring net losses and negative cash flows from operations since inception and anticipate this to continue for most of 2025. Our plan for 2025 is to invest in increasing demand and adding capacity to support our direct billing channel, while making investments to increase revenues in the U.S. O&P channel.
The following table sets forth our revenue, cost of revenue, gross profit and gross margin for each of the periods presented.
|
|
|
|
|
|
For the Three Months Ended March 31, |
Period- to-Period Change |
|
2025 |
2024 |
$ |
% |
Product revenue |
$9,831,814 |
$3,754,389 |
$6,077,425 |
162% |
Cost of revenue |
3,222,184 |
1,455,345 |
1,766,839 |
121% |
Gross profit |
$6,609,630 |
$2,299,044 |
$4,310,586 |
187% |
Gross margin % |
67.2% |
61.2% |
|
6.0% |
Revenues
We derive revenue primarily from providing devices directly to patients and billing insurance companies directly. We also sell our products to O&P providers in the U.S, Europe and Australia, to the VA, and to rehabilitation hospitals. Though we increasingly provide devices directly to patients, we sometimes utilize the clinical services of O&P providers for which they are paid a fee.
Total revenue increased by approximately $6.1 million, or 162%, for the three months ended March 31, 2025, as compared to the same period in 2024. The product revenue increase was driven primarily by higher direct billing revenues due to a higher average selling price (“ASP”), as well as a higher number of revenue units as we were able to serve Medicare Part B beneficiaries in volume at the published fees starting in April 2024. Revenues generated through the direct billing channel were approximately $7.8 million, or 79% of product revenue in the three months ended March 31, 2025, compared to approximately $2.2 million, or 60%, of product revenue in the three months ended March 31, 2024.
Cost of Revenue and Gross margin
Cost of revenue consists of direct costs for the manufacturing, printing of orthotic parts, fabrication and fitting of our products, changes in inventory and warranty reserves and overhead costs allocated to cost of revenue.
Gross margin was 67.2% for the three months ended March 31, 2025, compared to 61.2% for the three months ended March 31, 2024. The increase in gross margin was primarily due to a higher ASP discussed above and greater absorption of fixed costs into inventory.
Operating expenses
The following table sets forth our operating expenses for each of the periods presented.
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
Period-to-Period Change |
|
|
2025 |
|
2024 |
|
$ |
|
% |
Research and development |
|
$1,790,024 |
|
$956,215 |
|
$833,809 |
|
87% |
Selling, clinical and marketing |
|
4,395,804 |
|
2,361,845 |
|
2,033,959 |
|
86% |
General and administrative |
|
3,944,056 |
|
2,869,751 |
|
1,074,305 |
|
37% |
Total operating expenses |
|
$10,129,884 |
|
$6,187,811 |
|
$3,942,073 |
|
64% |
Research and development
Research and development (“R&D”) expenses consist of costs for our R&D personnel, including salaries, benefits, bonuses and stock-based compensation, product development costs, clinical studies, and the cost of certain third-party contractors and travel expense. R&D costs are expensed as they are incurred. We intend to accelerate our R&D efforts in 2025 and expect R&D costs to increase on an annual basis.
R&D expenses increased by approximately $0.8 million, or 87%, during the three months ended March 31, 2025, as compared to the same period in 2024. The increase was primarily due to higher costs for payroll and outside engineering services as we are accelerating our sustaining engineering and product development efforts.
Selling, clinical and marketing
Selling, clinical, and marketing (“SC&M”) expenses consist of costs for our field clinical staff, clinical training organization, and marketing personnel, including salaries, benefits, bonuses, stock-based compensation and sales commissions, costs of advertising, marketing and promotional events, corporate communications, product marketing and travel expenses. Variable compensation for personnel engaged in sales and marketing activities is generally earned and recorded as expense in the period in which the measurable work is performed. We expect SC&M expenses to increase in 2025 as we increase our advertising spending and clinical capacity to grow revenues in our direct billing channel.
SC&M expenses increased by approximately $2.0 million or 86% during the three months ended March 31, 2025, as compared to the same period in 2024. The increase was primarily due to higher payroll costs due to increased headcount in our clinical functions to support higher expected sales volume in 2025 and higher advertising expense.
General and administrative
General and administrative (“G&A”) expenses consist primarily of costs for administrative, reimbursement, and finance personnel, including salaries, benefits, bonuses and stock-based compensation, professional fees associated with legal matters, consulting expenses, costs for pursuing insurance reimbursements for our products and costs required to comply with the regulatory requirements of the SEC, as well as costs associated with accounting systems, insurance premiums and other corporate expenses. We expect that G&A expenses will increase in 2025 as a result of increasing our reimbursement capacity in order to grow revenue in the direct billing channel.
G&A increased by approximately $1.1 million or 37%, during the three months ended March 31, 2025, as compared to the same period in 2024. The increase was primarily due to increased payroll costs due to increased headcount in our reimbursement and human resource functions as part of our plan to increase our reimbursement capacity in 2025 in order to serve Medicare Part B patients, as well as higher incentive compensation accrual due to the increased head count.
Other (income), net
The following table sets forth our other income, net for each of the periods presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
Period-to-Period Change |
|
|
|
2025 |
|
|
2024 |
|
|
$ |
|
|
% |
|
Interest income, net |
|
$ |
(191,991 |
) |
|
$ |
(135,293 |
) |
|
$ |
(56,698 |
) |
|
|
42 |
% |
Total other income, net |
|
$ |
(191,991 |
) |
|
$ |
(135,293 |
) |
|
$ |
(56,698 |
) |
|
N/M |
|
Other (income) expense, net was income of approximately $192,000 for the three months ended March 31, 2025 compared to income of approximately $135,300 for the same period in 2024. The increase in other income was due primarily to higher interest income as a result of a higher average investment balance compared to the prior year period.
Income tax expense
Income tax expense recorded during the three months ended March 31, 2025 and 2024 represents the provision for income taxes for our wholly-owned subsidiary, Myomo Europe GmbH. Income tax expense increased in the three months ended March 31, 2025 as a result of higher taxable income compared to the same period in 2024.
Adjusted EBITDA
We believe that the presentation of Adjusted EBITDA, a non-GAAP financial measure, provides investors with additional information about our financial results. Adjusted EBITDA is an important supplemental measure used by our board of directors and management to evaluate our operating performance from period-to-period on a consistent basis and as a measure for planning and forecasting overall expectations and for evaluating actual results against such expectations.
We define Adjusted EBITDA as earnings before interest, taxes, depreciation and amortization adjusted for, stock-based compensation and other unusual items.
Adjusted EBITDA is not in accordance with, or an alternative to, measures prepared in accordance with U.S. GAAP. In addition, this non-GAAP measure is not based on any comprehensive set of accounting rules or principles. As a non-GAAP measure, Adjusted EBITDA has limitations in that it does not reflect all of the amounts associated with our results of operations as determined in accordance with U.S. GAAP. In particular:
•Adjusted EBITDA does not reflect the amounts we paid in taxes or other components of our tax provision;
•Adjusted EBITDA does not include interest income;
•Adjusted EBITDA does not include depreciation expense from fixed assets; and
•Adjusted EBITDA does not include the impact of stock-based compensation;
Because of these limitations, you should consider Adjusted EBITDA alongside other financial performance measures including net income (loss) and our financial results presented in accordance with U.S. GAAP.
The following table provides a reconciliation of net loss to Adjusted EBITDA for each of the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
2025 |
|
|
2024 |
|
GAAP net loss |
|
$ |
(3,465,058 |
) |
|
$ |
(3,835,632 |
) |
Adjustments to reconcile to Adjusted EBITDA: |
|
|
|
|
|
|
Interest income, net |
|
|
(191,991 |
) |
|
|
(135,293 |
) |
Depreciation expense |
|
|
158,442 |
|
|
|
29,685 |
|
Stock-based compensation |
|
|
540,204 |
|
|
|
320,288 |
|
Income tax expense |
|
|
136,795 |
|
|
|
82,158 |
|
Adjusted EBITDA |
|
$ |
(2,821,608 |
) |
|
$ |
(3,538,794 |
) |
Liquidity and Capital Resources
Liquidity
We measure our liquidity in a number of ways, including the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
Cash and cash equivalents |
|
$ |
19,793,799 |
|
|
$ |
24,372,373 |
|
Short-term investments |
|
|
1,730,460 |
|
|
|
492,990 |
|
Total |
|
|
21,524,259 |
|
|
|
24,865,363 |
|
Working capital |
|
$ |
19,422,008 |
|
|
$ |
22,618,158 |
|
As of March 31, 2025, we had working capital of approximately $19.5 million and stockholders’ equity of approximately $21.7 million. We used approximately $2.7 million in cash for operating activities during the three months ended March 31, 2025.
We have historically funded our operations through financing activities, including raising equity and debt capital. In December 2024, we completed a public equity offering, pursuant to which we sold 3,450,000 shares of common stock at $5.00 per share, generating net proceeds after fees and expenses of approximately $15.8 million. In January 2024, we completed a registered direct equity offering, pursuant to which we sold 1,354,218 shares of common stock and 224,730 pre-funded warrants at $3.80 per share, or $3.7999 per pre-funded warrant, generating net proceeds after fees and expenses of approximately2 $5.4 million. In July 2024, we entered into a Loan and Security Agreement with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company, which provides us the ability to borrow up to $4.0 million against eligible accounts receivable. The line of credit remains undrawn as of the issuance date of these financial statements. Availability under the line of credit is approximately $216,600 based on eligible accounts receivable as of March 31, 2025. We amended the Loan and Security Agreement in February 2025 to provide for, among other changes, a $3.0 million term loan facility, which is available to be drawn at any time until February 28, 2026. Considering our cash balance and availability under our debt arrangements as of March 31, 2025 and our operating plans discussed below, we believe there will be sufficient cash to fund our operations and capital expenditures for the next 12 months from the date of this report.
Our operating plans are primarily focused on growing revenues in our direct billing channel in 2025, while we work concurrently on growing revenues in the O&P channel. This involves increasing our advertising spending and adding headcount to increase our clinical, reimbursement and manufacturing capacity in order to serve a higher volume of patients in 2025. These investments are expected to result in negative cash flows for at least the first three quarters of 2025.
Our business is dependent upon reimbursement of our products by insurance companies and government-controlled health care plans such as Medicare and Medicaid in the United States and by statutory health insurance plans in Germany, which could prevent our revenues from growing to the level necessary to return to cash flow breakeven and remain that way on a sustaining basis. We believe that we have access to capital resources, if necessary, through potential public or private equity offerings, debt financings, or other means. If we are unable to obtain adequate funds on reasonable terms, we may be required to significantly curtail or discontinue operations or obtain funds by entering into financing agreements on unattractive terms. We may also explore strategic alternatives for the purpose of maximizing stockholder value. There can be no assurance we will be successful in implementing our plans to sustain our operations and continue to conduct our business.
Cash Flows
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2025 |
|
|
2024 |
|
Net cash used in operating activities |
|
$ |
(2,676,899 |
) |
|
$ |
(3,245,564 |
) |
Net cash used in investing activities |
|
|
(1,896,098 |
) |
|
|
(3,542,565 |
) |
Net cash (used in) provided by financing activities |
|
|
(36,506 |
) |
|
|
5,361,909 |
|
Effect of foreign change rate changes on cash |
|
|
30,929 |
|
|
|
(10,360 |
) |
Net increase (decrease) in cash, cash equivalents and restricted cash |
|
$ |
(4,578,574 |
) |
|
$ |
(1,436,580 |
) |
Operating Activities. The net cash used in operating activities for the three months ended March 31, 2025 was primarily used to fund a net loss of approximately $3.5 million, adjusted for non-cash expenses in the aggregate amount of approximately $1.0 million and by approximately $0.2 million of cash used by net changes in the levels of operating assets and liabilities, primarily related to increases in accounts receivable, inventory and prepaid expenses and other current assets, offset by an increase in accounts payable and accrued expenses.
The net cash used in operating activities for the three months ended March 31, 2024 was primarily used to fund a net loss of approximately $3.8 million, adjusted for non-cash expenses in the aggregate amount of approximately $0.4 million, offset by approximately $0.2 million of
cash generated by net changes in the levels of operating assets and liabilities, primarily related to a decrease in accounts receivable and an increase in accounts payable and accrued expenses, offset by an increase in inventory.
Investing Activities. During the three months ended March 31, 2025 and 2024, our cash used in investing activities of approximately $1.9 million and $3.5 million, respectively, was primarily related to our purchase of short-term investments and purchases of equipment.
Financing Activities. There was less than $0.1 million in cash used by financing activities and $5.4 million in cash generated from financing activities during the three months ended March 31, 2025 and 2024, respectively, 2024. Cash used during the three months ended March 31, 2025 was due to payment of issuance costs associated with the amendment to our line of credit agreement with Silicon Valley Bank. Cash generated by financing activities in the three months ended March 31, 2024 was due entirely to the net proceeds from our equity offering in January 2024.
Critical Accounting Estimates
Our discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these consolidated financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses. We base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances. These estimates and assumptions are reviewed on an on-going basis and updated as appropriate. Materially different results can occur if circumstances change and additional information becomes known. Actual results may differ from these estimates. Refer to Note 3 - Summary of Significant Accounting Policies. Our most critical accounting estimate is the timing and amount of revenue recognition based on assertions and estimates of payments from certain insurance payers.
Timing and Amount of Revenue Recognition
The timing and amount of revenue recognized is determined based on certain estimates. For revenue derived from patients with Medicare Part B, we determined we had sufficient payment history in order to recognize revenue upon delivery of the device to the patient based on the published fees by CMS. With respect to patients with Medicare Advantage or other commercial insurance, except for a small number of payers, we do not have contracts to establish pricing or provide evidence of an arrangement. As a result, we rely on a history of payments after receiving an insurance authorization, delivery of the device and submission of a claim as evidence of an arrangement. Payment history is also used to estimate how much we expect to be paid upon delivery of our device and submission of an insurance claim, which determines how much revenue we recognize. For other Medicare Advantage and other commercial insurance payers, we have determined that we do not have sufficient collection history with the payer to assert evidence of an arrangement and collectibility. For these payers, revenue is recognized at payment, which is when we can determine how much we will be paid for the device.
Recent Accounting Standards
Information regarding new accounting standards is included in Note 3 — Recently Adopted Accounting Standards to our unaudited condensed consolidated financial statements contained in Item 1 of this Quarterly Report on Form 10-Q.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
This item is not applicable to us as a smaller reporting company.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Our management, with the participation of our Chief Executive Officer, our principal executive officer, and our Chief Financial Officer, our principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2025, the end of the period covered by this Quarterly Report on Form 10-Q.
Management recognizes that any disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible
controls and procedures. Based on the evaluation of our disclosure controls and procedures as of December 31, 2024, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were not effective as of such date at the reasonable assurance level due to the material weakness in the design of effective information technology general controls over our enterprise reporting system described below.
Material Weakness
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.
We identified a material weakness as of December 31, 2024 related to a lack of design and maintenance of effective information technology general controls due to privileged access rights for two individuals, lack of formal processes for user provisioning, periodic user access review and change management for financial reporting system and lack of formal reviews of key third party service provider SOC reports. The deficiencies could allow for inappropriate financial transactions to be recorded that would not be detected by our other manual controls, rendering them ineffective. This material weakness has not resulted in any identified misstatements to our financial statements.
Notwithstanding the material weaknesses in our internal control over financial reporting, our management has concluded that our condensed consolidated financial statements and related notes thereto included in this Quarterly Report on Form 10-Q fairly present in all material respects the financial condition, results of operations and cash flows of the Company and have been prepared in accordance with generally accepted accounting principles. Our Chief Executive Officer and Chief Financial Officer have certified that, based on each such officer’s knowledge, the financial statements, as well as the other financial information included in this Quarterly Report on Form 10-Q, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this Quarterly Report on Form 10-Q.
Management’s Plan for Remediation of the Material Weakness
Management, with the oversight of the Audit Committee of the Board of Directors, is committed to maintaining a strong internal control environment. In response to the material weakness identified above, we intend to remediate the material weakness in internal control over financial reporting by formalizing our process and review of user provisioning to enable only the appropriate personnel to have access, including giving rights to provision access to our financial reporting system to an individual outside our finance organization, and formalizing change management processes and review of key third party service provider SOC reports.
As of March 31, 2025, we have implemented changes in the provisioning of access rights and procedures to improve our change management processes. Other enhancements to our information technology general controls are expected to be implemented in the second quarter of 2025.
We believe that these actions, when fully implemented, will remediate the material weakness. However, the material weakness will not be considered fully remediated until the design of these controls are determined to operate for a sufficient period of time and management has concluded, through testing, that these controls are effective. As we continue to evaluate operating effectiveness and monitor improvements to our internal control over financial reporting, we may take additional measures to address control deficiencies or modify the remediation plan described above.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f). Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
Our management assessed the effectiveness of our internal control over financial reporting as of March 31, 2025. In making this assessment, we used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control - Integrated Framework (2013). Based on our assessment, and as a result of the material weakness described above, we believe that as of March 31, 2025, our internal control over financial reporting was not effective at the reasonable assurance level. However, after giving full consideration to this material weakness, our management has concluded that our condensed consolidated financial statements present fairly, in all material respects, our financial position, results of operations and cash flows for the periods disclosed in conformity with generally accepted accounting principles.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) identified in connection with the evaluation of our internal control that occurred during the quarter ended March 31, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Part II. OTHER INFORMATION
Item 1. Legal Proceedings
The Company may be involved in legal proceedings, claims and assessments arising from the ordinary course of business. Such matters are subject to many uncertainties, and outcomes are not predictable with assurance. There is no material litigation against the Company at this time that is required to be disclosed under Item 103 of Regulation S-K.
Item 1A. Risk Factors
Except as set forth below, there have been no material changes to our risk factors from those disclosed in Part I, Item 1A. "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2024.
Risks Related to Our Operating and Financial Results
If CMS amends, restricts, or retracts coverage requirements, its billing contractors and insurers offering Medicare Advantage insurance plans may restrict what they reimburse for the MyoPro, which would have an adverse effect on our business.
Revenues from patients who are covered by Medicare Advantage insurance plans have historically been a significant portion of our overall revenues. However, Medicare Advantage plans have been reducing the number of authorizations for the MyoPro since the second half of 2024, which is negatively impacting our revenues. Approximately 17% and 38% of our product revenues were derived from patients with Medicare Advantage insurance plans for the three months ended March 31, 2025 and 2024, respectively. Since CMS published reimbursement amounts for the MyoPro in April 2024, revenues from Medicare Part B patients represented 59% of total revenue for the three months ended March 31, 2025. If CMS amends, restricts, or retracts its November 2023 rule classifying MyoPro as a brace, amends or retracts any published fees, or establishes more restrictive inclusion criteria for coverage, our Medicare revenues could be negatively impacted and insurers offering Medicare Advantage insurance plans may no longer cover or adequately reimburse for the MyoPro. Further, continued utilization management efforts by Medicare Advantage plans could result in further decreases in authorizations. As a result of these factors, our overall revenues and cash flows would be negatively impacted, which could have an adverse effect on our business. See “Risks Related to our Reliance on Third Parties—We may not be able to obtain third-party payer reimbursement, including reimbursement by Medicare, for our products” for additional information.
Changes made by direct to consumer advertising companies in how they reach prospective patients could adversely impact our lead generation efforts, resulting in higher advertising cost per addition to our patient pipeline and have an adverse effect on revenues.
We rely on a variety of direct-to-consumer advertising companies to help us reach and educate prospective patients, their caregivers and families regarding the potential benefits of the MyoPro. These companies are subject to various privacy laws and regulations regarding the use of protected patient health and other identifying information in advertising activities. Changes in the algorithms and other methods used by these companies to remain in compliance with these laws and regulations, which we do not control, nor have input into, may adversely affect our lead generation, our advertising cost per addition to our patient pipeline, which we refer to as cost per pipeline add, and our revenues. For instance, in the first quarter of 2025, a social media advertising company we utilize made a change to the algorithm they use to target prospective patients. This change resulted in decreased lead generation for the first half of the first quarter and a higher cost per pipeline add in the first quarter, which is also expected to negatively impact our revenue growth in the second quarter of 2025. Methods and algorithms used by media companies are continually evolving and we cannot provide any assurance that future changes will not impact our revenues and results of operations.
Significant political, trade, and regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations.
We sell our products in countries throughout the world. Significant political, trade, or regulatory developments in the jurisdictions in which we sell our products, such as those stemming from the change in U.S. federal administration, are difficult to predict and may have a material adverse effect on us. These developments may include tariffs or changes in reimbursement policies for Medicaid and Medicare. For example, in April 2025, the United States imposed broad tariffs on imports from virtually all countries, with particularly high tariffs on imports from China. Since this announcement, most tariffs for countries other than China have been suspended temporarily. In response to tariffs, some countries have implemented retaliatory tariffs on U.S. goods, while others seek to negotiate agreements regarding U.S. imposed tariffs. Historically, tariffs have led to increased trade and political tensions and, to date, the outcome of the negotiations between the United States and the various countries is not yet clear. While we estimate that tariffs on imports, if fully implemented as announced in April 2025, are expected to have less than a 100 basis point (1%) impact on gross margin in 2025, we cannot provide any assurance that changes in political,
trade, regulatory, or economic conditions, including U.S. trade policies, will not have a material adverse effect on our financial condition or results of operations.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds from Registered Securities
None.
Item 5. Other Information
(c)
The following table discloses any officer (as defined in Rule 16(a)-1(f) under the Securities Exchange Act of 1934, as amended) or director who adopted a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement (as such terms are defined in Item 408 of Regulation S-K) during the three months ended March 31, 2025:
|
|
|
|
|
|
Name and Title |
Type of Trading Arrangement |
Action Taken (Date of Action) |
Duration or End Date |
Aggregate Number of Securities to be Sold |
Description of Trading Arrangement |
David A. Henry Chief Financial Officer |
Trading Plan Intended to satisfy the affirmative defense conditions of Securities Exchange Act Rule 10b5-1(c) |
Adopted (March 12, 2025) |
December 31, 2026 |
129,020 |
Sales of shares of our common stock pursuant to the terms of the trading plan |
Other than as disclosed above, no other officer or director adopted, modified or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement (as such terms are defined in Item 408 of Regulation S-K) during the three months ended March 31, 2025.
Item 6. Exhibits
The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth on the Exhibits Index, which is incorporated by reference.
Exhibits Index
|
|
|
Exhibit No. |
|
Exhibit Description |
3.1 |
|
Eighth Amended and Restated Certificate of Incorporation (Incorporated by reference to Exhibit 2.3 contained in the Registrant’s Form 1-A filed on January 6, 2017) |
|
|
|
3.2 |
|
Amended and Restated Bylaws (Incorporated by reference to Exhibit 2.4 contained in the Registrant’s Form 1-A filed on January 6, 2017) |
|
|
|
3.3 |
|
Certificate of Amendment to the Eighth Amended and Restated Certificate of Incorporation, as amended, of Myomo, Inc., filed with the Secretary of the State of Delaware on January 30, 2020 (Incorporated by reference to Exhibit 3.1 contained in the Registrant’s Form 8-K filed on January 30, 2020) |
|
|
|
3.4 |
|
Second certificate of Amendment to the Eighth Amended and Restated Certificate of Incorporation, as amended, of Myomo, Inc., filed with the Secretary of the State of Delaware on June 10, 2021 (Incorporated by reference to Exhibit 3.1 contained in the Registrant’s Form 8-K filed on June 15, 2021) |
|
|
|
10.1 |
|
First Amendment to Loan and Security Agreement, dated February 18, 2025, between the Registrant and Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (Incorporated by reference to Exhibit 10.1 contained in the Registrant's Form 8-K filed on February 20, 2025). |
|
|
|
31.1* |
|
Certification of Chief Executive Officer, pursuant to Rule 13a-14(a) or 15(d)-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
31.2* |
|
Certification of Chief Financial Officer, pursuant to Rule 13a-14(a) or 15(d)-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.1+ |
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.2+ |
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
101.INS* |
|
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH* |
|
Inline XBRL Taxonomy Extension Schema Document with embedded linkbase documents. |
104* |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Filed herewith.
+ The certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Quarterly Report on Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference. Such certification will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date May 7, 2025
|
|
|
Myomo, Inc. |
|
|
|
/s/ David A. Henry |
|
David A. Henry |
|
Chief Financial Officer (Principal Financial and Accounting Officer) |
Exhibit 31.1
Certification Pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934
I, Paul R. Gudonis, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Myomo, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: May 07, 2024
|
/s/ Paul R. Gudonis |
Paul R. Gudonis |
President and Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
Certification Pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934
I, David A. Henry, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Myomo, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: May 07, 2024
|
/s/ David A. Henry |
David A. Henry |
Chief Financial Officer (Principal Financial Officer) |
Exhibit 32.1
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
I, Paul R. Gudonis, President and Chief Executive Officer of Myomo, Inc. (the “Company”), certify, pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, that:
(1) the Quarterly Report on Form 10-Q of the Company for the three months ended March 31, 2024 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m or 780(d)); and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: May 07, 2024
|
/s/ Paul R. Gudonis |
Paul R. Gudonis |
President and Chief Executive Officer (Principal Executive Officer) |
Exhibit 32.2
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
I, David A. Henry, Chief Financial Officer of Myomo, Inc. (the “Company”), certify, pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, that:
(1) the Quarterly Report on Form 10-Q of the Company for the three months ended March 31, 2024 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m or 780(d)); and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: May 07, 2024
|
/s/ David A. Henry |
David A. Henry |
Chief Financial Officer (Principal Financial Officer) |
v3.25.1
Document and Entity Information - shares
|
3 Months Ended |
|
Mar. 31, 2025 |
May 02, 2025 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Period End Date |
Mar. 31, 2025
|
|
Document Fiscal Year Focus |
2025
|
|
Document Fiscal Period Focus |
Q1
|
|
Trading Symbol |
MYO
|
|
Entity Registrant Name |
MYOMO, INC.
|
|
Entity Central Index Key |
0001369290
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Shell Company |
false
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
false
|
|
Entity Common Stock, Shares Outstanding |
|
35,978,922
|
Entity File Number |
001-38109
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Tax Identification Number |
47-0944526
|
|
Entity Address, Address Line One |
45 Blue Sky Drive
|
|
Entity Address, Address Line Two |
Suite 101
|
|
Entity Address, City or Town |
Burlington
|
|
Entity Address, State or Province |
MA
|
|
Entity Address, Postal Zip Code |
02114
|
|
City Area Code |
617
|
|
Local Phone Number |
996-9058
|
|
Title of 12(b) Security |
Common Stock, $0.0001 par value per share
|
|
Security Exchange Name |
NYSEAMER
|
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DE
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v3.25.1
Condensed Consolidated Balance Sheets - USD ($)
|
Mar. 31, 2025 |
Dec. 31, 2024 |
Current Assets: |
|
|
Cash and cash equivalents |
$ 19,793,799
|
$ 24,372,373
|
Short-term investments |
1,730,460
|
492,990
|
Accounts receivable, net |
4,663,398
|
3,825,291
|
Inventories, net |
3,368,502
|
3,165,965
|
Prepaid expenses and other current assets |
1,541,118
|
933,377
|
Total Current Assets |
31,097,277
|
32,789,996
|
Restricted Cash |
375,000
|
375,000
|
Operating lease assets with right of use, net |
7,295,711
|
7,584,663
|
Equipment, net |
1,842,254
|
1,330,008
|
Other assets |
257,085
|
164,412
|
Total Assets |
40,867,327
|
42,244,079
|
Current Liabilities: |
|
|
Accounts payable and accrued expenses |
10,448,565
|
9,021,817
|
Current operating lease liability |
765,616
|
748,021
|
Income taxes payable |
331,236
|
318,885
|
Deferred revenue |
129,852
|
83,115
|
Total Current Liabilities |
11,675,269
|
10,171,838
|
Non-current operating lease liability |
7,504,994
|
7,358,184
|
Total Liabilities |
19,180,263
|
17,530,022
|
Commitments and Contingencies |
0
|
0
|
Stockholders’ Equity: |
|
|
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued or outstanding |
0
|
0
|
Common stock par value $0.0001 per share, 65,000,000 shares authorized; 34,438,036 and 34,378,297 shares issued as of March 31, 2025 and December 31, 2024, respectively; and 34,438,009 and 34,378,270 shares outstanding at March 31, 2025 and December 31, 2024, respectively |
3,446
|
3,439
|
Additional paid-in capital |
128,386,223
|
127,846,026
|
Accumulated other comprehensive loss |
(116,545)
|
(14,406)
|
Accumulated deficit |
(106,579,596)
|
(103,114,538)
|
Treasury stock, 27 shares at cost |
(6,464)
|
(6,464)
|
Total Stockholders’ Equity |
21,687,064
|
24,714,057
|
Total Liabilities and Stockholders’ Equity |
$ 40,867,327
|
$ 42,244,079
|
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v3.25.1
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Mar. 31, 2025 |
Dec. 31, 2024 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
10,000,000
|
10,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
65,000,000
|
65,000,000
|
Common stock, shares issued |
34,438,036
|
34,378,297
|
Common stock, shares outstanding |
34,438,009
|
34,378,270
|
Treasury shares at cost |
27
|
27
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.25.1
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
Mar. 31, 2025 |
Mar. 31, 2024 |
Revenue |
$ 9,831,814
|
$ 3,754,389
|
Cost of revenue |
3,222,184
|
1,455,345
|
Gross profit |
6,609,630
|
2,299,044
|
Operating expenses: |
|
|
Research and development |
1,790,024
|
956,215
|
Selling, clinical and marketing |
4,395,804
|
2,361,845
|
General and administrative |
3,944,056
|
2,869,751
|
Total operating expenses |
10,129,884
|
6,187,811
|
Loss from operations |
(3,520,254)
|
(3,888,767)
|
Other (income) expense, net |
|
|
Interest income, net |
(191,991)
|
(135,293)
|
Total other expense (income), net |
(191,991)
|
(135,293)
|
Loss before income taxes |
(3,328,263)
|
(3,753,474)
|
Income tax expense |
136,795
|
82,158
|
Net loss |
$ (3,465,058)
|
$ (3,835,632)
|
Weighted average number of common shares outstanding: |
|
|
Basic |
41,454,472
|
36,752,597
|
Diluted |
41,454,472
|
36,752,597
|
Net loss per share attributable to common stockholders |
|
|
Basic |
$ (0.08)
|
$ (0.1)
|
Diluted |
$ (0.08)
|
$ (0.1)
|
Product revenue |
|
|
Revenue |
$ 9,831,814
|
$ 3,754,389
|
X |
- DefinitionThe aggregate cost of goods produced and sold and services rendered during the reporting period.
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v3.25.1
Condensed Consolidated Statements of Comprehensive Loss (unaudited) - USD ($)
|
3 Months Ended |
Mar. 31, 2025 |
Mar. 31, 2024 |
Statement of Comprehensive Income [Abstract] |
|
|
Net Income (Loss) |
$ (3,465,058)
|
$ (3,835,632)
|
Other comprehensive income, net of tax: |
|
|
Foreign currency translation adjustments |
(102,139)
|
63,842
|
Other comprehensive (loss) income |
(102,139)
|
63,842
|
Comprehensive loss |
$ (3,567,197)
|
$ (3,771,790)
|
X |
- DefinitionAmount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.
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v3.25.1
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($)
|
Total |
Common Stock |
Additional Paid-in Capital [Member] |
Comprehensive Loss [Member] |
Accumulated Comprehensive Income [Member] |
Accumulated Deficit [Member] |
Treasury Stock [Member] |
Beginning balance at Dec. 31, 2023 |
$ 8,989,350
|
$ 2,715
|
$ 105,840,239
|
|
$ 83,669
|
$ (96,930,809)
|
$ (6,464)
|
Beginning balance, shares at Dec. 31, 2023 |
|
27,135,061
|
|
|
|
|
|
Beginning balance, shares at Dec. 31, 2023 |
|
|
|
|
|
|
27
|
Common stock issued upon vesting of restricted stock units |
|
$ 31
|
(31)
|
|
|
|
|
Common stock issued upon vesting of restricted stock units, Shares |
|
300,544
|
|
|
|
|
|
Proceeds from sale of common stock in public offering, value |
4,598,771
|
$ 135
|
4,598,636
|
|
|
|
|
Proceeds from sale of common stock in public offering, shares |
|
1,354,218
|
|
|
|
|
|
Proceeds from sale of pre-funded warrants, value |
$ 763,138
|
|
763,138
|
|
|
|
|
Exercise of stock options, shares |
0
|
|
|
|
|
|
|
Stock-based compensation |
$ 320,288
|
|
320,288
|
|
|
|
|
Unrealized gains on foreign currency adjustments |
63,842
|
|
|
$ 63,842
|
|
|
|
Net Income (Loss) |
(3,835,632)
|
|
|
|
|
(3,835,632)
|
|
Ending balance at Mar. 31, 2024 |
10,899,757
|
$ 2,881
|
111,522,270
|
147,511
|
|
(100,766,441)
|
$ (6,464)
|
Ending balance, shares at Mar. 31, 2024 |
|
28,789,823
|
|
|
|
|
|
Ending balance, shares at Mar. 31, 2024 |
|
|
|
|
|
|
27
|
Beginning balance at Dec. 31, 2024 |
$ 24,714,057
|
$ 3,439
|
127,846,026
|
(14,406)
|
|
(103,114,538)
|
$ (6,464)
|
Beginning balance, shares at Dec. 31, 2024 |
|
34,378,297
|
|
|
|
|
|
Beginning balance, shares at Dec. 31, 2024 |
27
|
|
|
|
|
|
27
|
Common stock issued upon vesting of restricted stock units |
|
$ 7
|
(7)
|
|
|
|
|
Common stock issued upon vesting of restricted stock units, Shares |
|
59,031
|
|
|
|
|
|
Common stock issued upon vesting of incentive stock options, Share |
|
708
|
|
|
|
|
|
Exercise of stock options, shares |
0
|
|
|
|
|
|
|
Stock-based compensation |
$ 540,204
|
|
540,204
|
|
|
|
|
Unrealized gains on foreign currency adjustments |
(102,139)
|
|
|
(102,139)
|
|
|
|
Net Income (Loss) |
(3,465,058)
|
|
|
|
|
(3,465,058)
|
|
Ending balance at Mar. 31, 2025 |
$ 21,687,064
|
$ 3,446
|
$ 128,386,223
|
$ (116,545)
|
|
$ (106,579,596)
|
$ (6,464)
|
Ending balance, shares at Mar. 31, 2025 |
|
34,438,036
|
|
|
|
|
|
Ending balance, shares at Mar. 31, 2025 |
27
|
|
|
|
|
|
27
|
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v3.25.1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
3 Months Ended |
Mar. 31, 2025 |
Mar. 31, 2024 |
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
Net loss |
$ (3,465,058)
|
$ (3,835,632)
|
Adjustments to reconcile net loss to net cash used in operations: |
|
|
Depreciation |
158,442
|
29,685
|
Stock-based compensation |
540,204
|
320,288
|
Accretion of discount on short-term investments |
(11,747)
|
(49,053)
|
Credit losses |
51,643
|
0
|
Amortization of deferred debt origination cost |
29,039
|
0
|
Amortization of right-of-use assets |
288,951
|
58,658
|
Other non-cash changes |
(34,171)
|
63,930
|
Changes in operating assets and liabilities: |
|
|
Accounts receivable |
(637,054)
|
718,676
|
Inventories |
(550,772)
|
(597,087)
|
Prepaid expenses and other current assets |
(628,186)
|
6,897
|
Other assets |
(70,210)
|
0
|
Accounts payable and accrued expenses |
1,440,877
|
87,041
|
Operating lease liabilities |
164,405
|
(115,191)
|
Deferred revenue |
46,738
|
(11,181)
|
Income taxes payable |
0
|
77,405
|
Net cash used in operating activities |
(2,676,899)
|
(3,245,564)
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
Purchases of equipment |
(670,688)
|
(59,808)
|
Maturities of short-term investments |
0
|
2,000,000
|
Purchases of short-term investments |
(1,225,410)
|
(5,482,757)
|
Net cash provided by (used in) investing activities |
(1,896,098)
|
(3,542,565)
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
Deferred debt origination costs |
(36,506)
|
0
|
Net proceeds from common stock offering |
0
|
4,598,771
|
Proceeds from sale of pre-funded warrants, net of offering costs |
0
|
763,138
|
Net cash (used in) provided by financing activities |
(36,506)
|
5,361,909
|
Effect of foreign exchange rate changes on cash |
30,929
|
(10,360)
|
Net increase in cash and cash equivalents |
(4,578,574)
|
(1,436,580)
|
Cash and cash equivalents beginning of year |
24,747,373
|
6,871,306
|
Cash, cash equivalents and restricted cash end of year |
$ 20,168,799
|
$ 5,434,726
|
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v3.25.1
Insider Trading Arrangements
|
3 Months Ended |
Mar. 31, 2025
shares
|
Trading Arrangements, by Individual |
|
Material Terms of Trading Arrangement |
Item 5. Other Information (c) The following table discloses any officer (as defined in Rule 16(a)-1(f) under the Securities Exchange Act of 1934, as amended) or director who adopted a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement (as such terms are defined in Item 408 of Regulation S-K) during the three months ended March 31, 2025:
|
|
|
|
|
|
Name and Title |
Type of Trading Arrangement |
Action Taken (Date of Action) |
Duration or End Date |
Aggregate Number of Securities to be Sold |
Description of Trading Arrangement |
David A. Henry Chief Financial Officer |
Trading Plan Intended to satisfy the affirmative defense conditions of Securities Exchange Act Rule 10b5-1(c) |
Adopted (March 12, 2025) |
December 31, 2026 |
129,020 |
Sales of shares of our common stock pursuant to the terms of the trading plan |
Other than as disclosed above, no other officer or director adopted, modified or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement (as such terms are defined in Item 408 of Regulation S-K) during the three months ended March 31, 2025.
|
Rule 10b5-1 Arrangement Adopted |
false
|
Non-Rule 10b5-1 Arrangement Adopted |
false
|
Rule 10b5-1 Arrangement Terminated |
false
|
Non-Rule 10b5-1 Arrangement Terminated |
false
|
Rule 10b5-1 Arrangement Modified |
false
|
Non-Rule 10b5-1 Arrangement Modified |
false
|
David A. Henry [Member] |
|
Trading Arrangements, by Individual |
|
Name |
David A. Henry
|
Title |
Chief Financial Officer
|
Rule 10b5-1 Arrangement Adopted |
true
|
Adoption Date |
March 12, 2025
|
Expiration Date |
December 31, 2026
|
Arrangement Duration |
659 days
|
Aggregate Available |
129,020
|
X |
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v3.25.1
Description of Business
|
3 Months Ended |
Mar. 31, 2025 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Description of Business |
Note 1 — Description of Business Myomo Inc. (“Myomo” or the Company”) is a wearable medical robotics company that develops, designs, and produces myoelectric orthotics for people with neuromuscular disorders. The MyoPro ® myoelectric upper limb orthosis product is registered with the U.S. Food and Drug Administration as a Class II medical device. The Company sells its products directly to patients, to Orthotics and Prosthetics ("O&P") providers around the world, the Veterans Health Administration, and distributors in Europe and Australia. The Company was incorporated in the State of Delaware on September 1, 2004 and is headquartered in Boston, Massachusetts.
|
X |
- DefinitionThe entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward.
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v3.25.1
Liquidity
|
3 Months Ended |
Mar. 31, 2025 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Liquidity |
Note 2 — Liquidity The Company incurred net losses of approximately $3,465,100 and $3,835,600 during the three months ended March 31, 2025 and 2024, respectively, and has an accumulated deficit of approximately $106,575,600 and $103,114,500 at March 31, 2025 and December 31, 2024, respectively. Cash used in operating activities was approximately $2,676,900 and $3,245,600 for the three months ended March 31, 2025 and 2024, respectively. Based upon its current cash, cash equivalents, and short-term investments, as well as the future expected cash flows, the Company believes that its available cash, cash equivalents, and short-term investments will fund its operations for at least the next twelve months from the issuance date of these financial statements. The Company has historically funded its operations through financing activities, including raising equity and debt. On December 6, 2024, the Company completed a public offering, selling 3,450,000 shares of common stock at $5.00 per share, generating net proceeds after taxes and fees of approximately $15.8 million. On January 19, 2024, the Company completed a registered direct equity offering, selling 1,354,218 shares of common stock and 224,730 pre-funded warrants to purchase common stock at $3.80 per share, or $3.7999 per pre-funded warrant, generating net proceeds after fees and expenses of approximately $5.4 million. See Note 7 - Common Stock and Warrants for further discussion. On July 11, 2024, the Company entered into a Loan and Security Agreement with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (“Silicon Valley Bank”), which provides the ability to borrow up to $4.0 million against eligible accounts receivable. In February 2025, the Company entered into an amendment to the Loan and Security Agreement, which among other changes, provides for a $3.0 million term loan facility which is available to be drawn at any time before February 28, 2026. The line of credit and term loan each remain undrawn as of the issuance date of these financial statements. Availability under the line of credit is approximately $216,600 based on eligible accounts receivable as of March 31, 2025. Financing activities, such as the recent public offering, have enabled the Company to sustain its operations. Management's operating plans are primarily focused on growing revenues in its direct billing channel, while working to grow revenues in its O&P channel. These plans include increasing advertising spending and adding headcount to support growth in its clinical, reimbursement, and manufacturing capacity in order to serve a higher volume of patients in 2025. These investments are expected to result in negative cash flows for at least the first three quarters of 2025. In addition, the Company believes that it has access to capital resources through possible public or private equity offerings, debt financings, or other means. Debt financing may contain other terms that are not favorable to the Company or its stockholders.
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v3.25.1
Summary of Significant Accounting Policies
|
3 Months Ended |
Mar. 31, 2025 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
Note 3 — Summary of Significant Accounting Policies Interim Financial Statements The accompanying unaudited condensed consolidated financial statements and notes are representations of the Company’s management, who are responsible for their integrity and objectivity. These statements have been prepared in accordance with United States generally accepted accounting principles ("U.S. GAAP") for interim financial information pursuant to Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for annual financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) that are considered necessary for a fair presentation of the condensed consolidated financial statements of the Company as of March 31, 2025 and for the three months ended March 31, 2025 and 2024. The results of operations for the three months ended March 31, 2025 are not necessarily indicative of the operating results for the fiscal year ending December 31, 2025, or any other period. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related disclosures of the Company as of December 31, 2024 and 2023 and for the years then ended, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. Basis of Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary Myomo Europe GmbH. All significant intercompany balances and transactions are eliminated. Comprehensive Income (Loss) Comprehensive loss includes all changes in equity during a period, except those resulting from investments by stockholders and distributions to stockholders. The Company's comprehensive loss includes changes in foreign currency translation adjustments and unrealized gains and losses on short term investments. There was a reclassification which management does not consider to be material out of accumulated other comprehensive income (loss) to other (income) expense related to realized gains or losses on short-term investments in the three months ended March 31, 2025. There were no reclassifications in the three months ended March 31, 2024. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America require management to make estimates and assumptions that affect certain reported amounts and disclosures. These estimates and assumptions are reviewed on an on-going basis and updated as appropriate. Actual results could differ from these estimates. The Company’s estimates include assertion of collectability with payers where the Company has no contracts as it relates to timing of revenue recognition and discount rate of leases. Cash, Cash Equivalents and Short-Term Investments The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents consist principally of deposit accounts and money market accounts at March 31, 2025 and December 31, 2024. The Company considers all investments with an original maturity of greater than three months but less than one year to be short-term investments. Short-term investments as of March 31, 2025 and December 31, 2024 consists of U.S. Treasury Bills and U.S. Government Agency Bills, which are classified as held-to-maturity, totaling approximately $1,760,500 and $493,000 as of March 31, 2025, and December 31, 2024, respectively. The Company determines the appropriate balance sheet classification of its investments at the time of purchases and evaluates the classification at each balance sheet date. All of the Company's U.S. Treasury Bills mature within the subsequent twelve months from the date of purchase. The Company’s cash balances as of March 31, 2025 and December 31, 2024 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
Cash and cash equivalents |
|
$ |
19,793,799 |
|
|
$ |
24,372,373 |
|
Restricted cash |
|
|
375,000 |
|
|
|
375,000 |
|
Total cash, cash equivalents, and restricted cash |
|
$ |
20,168,799 |
|
|
$ |
24,747,373 |
|
Accounts Receivable and Allowance for Credit Losses The Company reports accounts receivable at invoiced amounts less an allowance for credit losses accounts. The Company evaluates its accounts receivable on a continuous basis and, if necessary, establishes an allowance for credit losses based on a number of factors, including current credit conditions and customer payment history. The Company does not require collateral or accrue interest on accounts receivable and credit terms are generally 30 days. At March 31, 2025, and December 31, 2024, the Company recorded an allowance for credit losses accounts of approximately $107,900 and $56,300, respectively. Revenue Recognition The Company accounts for revenue under ASC 606, “Revenue from Contracts with Customers” and all of the related amendments (Topic 606). Revenues under Topic 606 are required to be recognized either at a “point in time” or “over time,” depending on the facts and circumstances of the arrangement and are evaluated using a five-step model. Generally, the Company recognizes revenue at a point in time. The Company recognizes revenue after applying the following five steps: 1)Identification of the contract, or contracts, with a customer, 2)Identification of the performance obligations in the contract, including whether they are distinct within the context of the contract, 3)Determination of the transaction price, including the constraint on variable consideration, 4)Allocation of the transaction price to the performance obligations in the contract, and 5)Recognition of revenue when, or as, performance obligations are satisfied. Revenue is recognized when control of these services is transferred to our customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those services. Product Revenue Increasingly, the Company derives its revenue from direct billing. The Company also derives revenue from the sale of its products to O&P providers in the United States and internationally and the Veterans Administration (“VA”). Under direct billing, the Company recognizes revenue when all of the following criteria are met: (i)The product has been delivered to the patient, including completion of initial instruction on its use, (ii)Collection is deemed probable and it has been determined that a significant reversal of the revenue to be recognized is not deemed probable when the uncertainty associated with the variable consideration is resolved. As an example, the Company will record revenue if it is notified that insurance intends to pay and a payment amount is provided, and (iii)The amount to be collected is estimable using the “expected value” estimation techniques, or the “most likely amount” as defined in ASC 606. For revenue derived from patients with Medicare Part B, the Company recognizes revenue upon delivery of the device to the patient based on the published fees by the Centers for Medicare & Medicaid Services ("CMS"). With respect to patients with Medicare Advantage or other commercial insurance, for payers where the Company either has a contract or in the absence of a contract, has demonstrated sufficient payment history, the Company will recognize revenue when it receives a pre-authorization from the insurance company and control passes to the patient upon delivery of the device in an amount that reflects the consideration the Company expects to receive in exchange for the device. During the three months ended March 31, 2025 and 2024, the Company made such a determination for certain insurers. These insurers represented approximately 13% and 54% of direct billing channel revenue for the three months ended March 31, 2025 and 2024, respectively. In cases where the Company is the direct provider and it does not have sufficient collection history with the payer, the Company recognizes revenue when payment is received, as then all of the revenue recognition criteria have been met. Depending on the timing of product deliveries to customers, which is when cost of revenue must be recorded, and when the Company meets the criteria to record revenue, there may be fluctuations in gross margin. During the three months ended March 31, 2025 and 2024, the Company recognized revenue of approximately $836,100 and $963,400, respectively, from third-party payers for which costs related to the completion of the Company’s performance obligations were not recorded in the current period. For revenues derived from O&P providers and the VA, the Company recognizes revenue when control passes to the customer in an amount that reflects the consideration the Company expects to receive in exchange for those services. Revenues may be recognized upon shipment or upon delivery, depending on the terms of the arrangement, provided that persuasive evidence of an arrangement exists, there are no uncertainties regarding customer acceptance and collectability is deemed probable. The Company has elected to record taxes collected from customers on a net basis and does not include tax amounts in revenue or cost of revenue. Contract Balances The timing of revenue recognition may differ from the timing of payment by customers. The Company records a receivable when revenue is recognized prior to payment and there is an unconditional right to payment. Alternatively, when payment precedes the provision of the related services, the Company records deferred revenue until the performance obligations are satisfied. The Company had deferred revenue of approximately $129,900 and $83,100 as of March 31, 2025 and December 31, 2024, respectively. Disaggregated Revenue from Contracts with Customers The following table presents revenue by major source:
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
2025 |
|
|
2024 |
|
Direct to patient |
|
$ |
7,807,777 |
|
|
$ |
2,234,742 |
|
Clinical/Medical providers |
|
|
2,024,037 |
|
|
|
1,519,647 |
|
Total revenue from contracts with customers |
|
$ |
9,831,814 |
|
|
$ |
3,754,389 |
|
Geographic Data The Company generated 87% of its total revenue from the United States, 13% from Germany, and less than 1% from other international locations for the three months ended March 31, 2025. The Company generated 75% of its total revenue from the United States, 22% from Germany, and 3% from other international locations, for the three months ended March 31, 2024. Cost of Revenue In conjunction with the adoption of ASC 606, there are certain cases in which the Company will expense costs when incurred as required by ASC 340-40-25. In certain cases, the Company provides the MyoPro device directly to patients, pending reimbursement from third-party payers, after which revenue is recognized. For the three months ended March 31, 2025 and 2024, the Company recorded cost of goods sold of approximately $32,400 and $112,100, respectively, without corresponding revenue. Direct billing fees paid to O&P providers for services they provide in conjunction with patient evaluations are expensed as incurred as required by ASC 340-40-25. These costs are recorded as sales and marketing expense. Internal costs incurred and fees paid to O&P providers to measure, fit and deliver the device to patients are expensed to cost of revenue. Advertising The Company charges the costs of advertising to operating expenses as incurred. Advertising expense amounted to approximately $1,609,700 and $787,200 during the three months ended March 31, 2025 and 2024, respectively. Foreign Currency Translation The functional currency of the Company’s foreign subsidiary, Myomo Europe GmbH, is the Euro. Foreign exchange translation gains and losses from the Euro to U.S. dollars are included in other comprehensive gain. The Company recorded a comprehensive loss of approximately $102,100 and comprehensive income of approximately $63,800 during the three months ended March 31, 2025 and 2024, respectively, which are included in accumulated other comprehensive loss in the condensed consolidated balance sheet. Transaction and translation foreign exchange gains and losses from a foreign currency to the functional currency are included in cost of revenue in the condensed consolidated statements of operations. Such amounts were immaterial for the three months ended March 31, 2025 and 2024. The balance sheet is translated using the spot rate on the day of reporting and the statement of operations is translated monthly using the average rate for the month. Net Loss per Share Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding, plus potentially dilutive common shares. Restricted stock, restricted stock units, stock options and warrants are excluded from the diluted net loss per share calculation when their impact is antidilutive. The Company reported a net loss for the three months ended March 31, 2025 and 2024, and as a result, all potentially dilutive common shares are considered antidilutive for these periods. Potential dilutive common shares issuable consist of the following at:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
2025 |
|
|
2024 |
|
Stock options |
|
|
22,383 |
|
|
|
23,929 |
|
Restricted stock units |
|
|
1,190,511 |
|
|
|
1,197,626 |
|
Other warrants |
|
|
— |
|
|
|
668,250 |
|
Total |
|
|
1,212,894 |
|
|
|
1,889,805 |
|
Due to their nominal exercise price of $0.0001 per share, a total of 7,061,519 and 8,496,249 outstanding pre-funded warrants as of March 31, 2025 and 2024, respectively, are considered common stock equivalents and are included in weighted average shares outstanding in the accompanying condensed consolidated statements of operations as of the respective closing dates of the Company's public equity offerings. Recently Adopted Accounting Standards In October 2023, the FASB issued ASU 2023-06, “Disclosure Improvements, Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative”, that adds 14 of the 27 identified disclosure or presentation requirements to the Codification, each amendment in the ASU will only become effective if the SEC removes the related disclosure or presentation from its existing regulations by June 30, 2027. The Company currently complies with these disclosure requirements as applicable under Regulation S-X or Regulation S-K and will adopt these new standards depending on timing of when they become effective, which is not expected to have a material impact on its financial position and results of operations. In December 2023, the FASB issued ASU 2023-09, “Accounting Standards Update, Income Taxes (Topic 740: Improvements to Income Tax Disclosures”. ASU 2023-09 focuses on income tax disclosures around effective tax rates and cash income taxes paid. This amendment in the ASU will become effective for public companies as of December 15, 2024 and effective to all other companies as of December 15, 2025. The Company will adopt these new standards when they become effective, which is not expected to have a material impact on its financial position and results of operations.
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v3.25.1
Inventories
|
3 Months Ended |
Mar. 31, 2025 |
Inventory Disclosure [Abstract] |
|
Inventories |
Note 4 — Inventories Inventories consist of the following at:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
Finished goods |
|
$ |
1,294,662 |
|
|
$ |
1,289,368 |
|
Work in process |
|
|
98,518 |
|
|
|
60,731 |
|
Parts and subassemblies |
|
|
1,975,322 |
|
|
|
1,815,866 |
|
Inventories, net |
|
$ |
3,368,502 |
|
|
$ |
3,165,965 |
|
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v3.25.1
Fair Value of Financial Instruments
|
3 Months Ended |
Mar. 31, 2025 |
Fair Value Disclosures [Abstract] |
|
Fair Value of Financial Instruments |
Note 5 — Fair Value of Financial Instruments The Company measures the fair value of financial assets and liabilities based on the guidance of ASC 820, “Fair Value Measurement” (“ASC 820”), which defines fair value, establishes a framework for measuring fair value, and establishes disclosures about fair value measurements. ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value: •Level 1 — Quoted prices available in active markets for identical assets or liabilities. •Level 2 — Observable inputs other than quoted prices included in Level 1, such as quotable prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data. •Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant unobservable inputs. The carrying amounts of the Company’s financial instruments such as cash and cash equivalents, accounts receivable and accounts payable, approximate fair value due to the short-term nature of these instruments. Cash equivalents consist of money market funds that limit their investments to only short-term U.S. Treasury Securities and repurchase agreements related to these securities. Short-term investments primarily consists of commercial paper and U.S. Treasury Bills and are carried on the condensed consolidated balance sheets at amortized cost which approximates fair value. Cash equivalents and short-term investments measured at fair value on a recurring basis at March 31, 2025 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In Active Markets for Identical Assets or Liabilities (Level 1) |
|
|
Significant Other Observable Inputs (Level 2) |
|
|
Significant Unobservable Inputs (Level 3) |
|
|
Total |
|
Money market funds |
|
$ |
18,359,786 |
|
|
|
— |
|
|
|
— |
|
|
$ |
18,359,786 |
|
Short-term investments |
|
$ |
— |
|
|
$ |
1,730,460 |
|
|
$ |
— |
|
|
$ |
1,730,460 |
|
Cash equivalents and short-term investments measured at fair value on a recurring basis at December 31, 2024 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In Active Markets for Identical Assets or Liabilities (Level 1) |
|
|
Significant Other Observable Inputs (Level 2) |
|
|
Significant Unobservable Inputs (Level 3) |
|
|
Total |
|
Money market funds |
|
$ |
23,334,374 |
|
|
|
— |
|
|
|
— |
|
|
$ |
23,334,374 |
|
Short-term investments |
|
|
— |
|
|
$ |
492,990 |
|
|
|
— |
|
|
$ |
492,990 |
|
|
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v3.25.1
Accounts Payable and Other Accrued Expenses
|
3 Months Ended |
Mar. 31, 2025 |
Payables and Accruals [Abstract] |
|
Accounts Payable and Accrued Expenses |
Note 6 - Accounts Payable and Other Accrued Expenses Accounts Payable and Other Accrued Expenses consists of the following at:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
Trade payables |
|
$ |
2,488,829 |
|
|
$ |
1,169,901 |
|
Accrued compensation and benefits |
|
|
4,830,562 |
|
|
|
5,009,385 |
|
Accrued professional services |
|
|
109,844 |
|
|
|
54,257 |
|
Warranty reserve |
|
|
139,409 |
|
|
|
129,615 |
|
Customer deposits |
|
|
2,774,665 |
|
|
|
2,194,804 |
|
Accrued insurance |
|
|
— |
|
|
|
128,556 |
|
Other |
|
|
105,256 |
|
|
|
335,299 |
|
|
|
$ |
10,448,565 |
|
|
$ |
9,021,817 |
|
|
X |
- DefinitionThe entire disclosure for accounts payable, accrued expenses, and other liabilities that are classified as current at the end of the reporting period.
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v3.25.1
Common Stock and Warrants
|
3 Months Ended |
Mar. 31, 2025 |
Equity [Abstract] |
|
Common Stock and Warrants |
Note 7 — Common Stock and Warrants On December 6, 2024, the Company completed a public equity offering, selling 3,450,000 shares of common stock at $5.00 per share, generating net proceeds after fees and expenses of approximately $15.8 million. On January 19, 2024, the Company completed a registered direct equity offering, selling 1,354,218 shares of common stock and 224,730 pre-funded warrants at $3.80 per share, or at $3.7999 per pre-funded warrant, generating proceeds after fees and expenses of approximately $5.4 million. Each pre-funded warrant is exercisable for one share of the Company’s common stock at a nominal exercise price of $0.0001 per share. As of March 31, 2025, 7,061,519 pre-funded warrants remain exercisable. Each pre-funded warrant is exercisable for one share of the Company’s common stock at a nominal exercise price of $0.0001 per share. No pre-funded warrants were exercised during the three months ended March 31, 2025 and 2024, respectively. During the three months ended March 31, 2025, 668,250 investor warrants issued in the Company’s public offering in February 2020 expired unexercised. 708 shares of common stock were issued through the exercise of stock options during the three months ended March 31, 2025 and none during the three months ended March 31, 2024. During the three months ended March 31, 2025 and 2024, 59,031 and 300,544 restricted stock units vested, respectively.
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v3.25.1
Line of Credit
|
3 Months Ended |
Mar. 31, 2025 |
Debt Disclosure [Abstract] |
|
Line of Credit |
Note 8 — Line of Credit On July 11, 2024 (the “Effective Date”), the Company, entered into a Loan and Security Agreement (the “Loan Agreement”) with Silicon Valley Bank. The Loan Agreement provides for a revolving line of credit whereby the Company may borrow up to $4,000,000 (the “Revolving Line”), which Revolving Line may be increased to $5,500,000 at Silicon Valley Bank’s sole discretion upon the occurrence of certain events. Amounts advanced by Silicon Valley Bank are based on 80% of “eligible accounts”, which includes all receivables in the United States, reduced by aged amounts and customers and insurance payers with concentrations in excess of defined limits, among other deductions. The outstanding principal amount of any advance shall accrue interest at a floating rate per annum equal to the greater of (i) 8.50% and (ii) the “prime rate” as published in The Wall Street Journal for the relevant period plus one-half percent (0.50%). The Revolving Line is secured on a first priority basis by all of Company’s assets other than intellectual property and certain customary exceptions. Any newly formed or acquired subsidiary of the Company or any guarantor under the Loan Agreement, will either join the Loan Agreement as a co-borrower or become a guarantor under the Loan Agreement, as determined by Silicon Valley Bank in its sole discretion. The Company intends to use the Revolving Line for working capital and general business purposes. The Revolving Line terminates, and any outstanding principal amount of all advances made thereunder, and any accrued and unpaid interest thereon, become immediately due and payable on the two year anniversary of the Effective Date. The Company must also pay Bank (i) a commitment fee of $20,000, (ii) an “Anniversary Fee” of 0.50% of the Revolving Line and (iii) an “Unused Revolving Line Facility Fee” of 0.50% per annum of the average unused portion of the Revolving Line. In addition, upon termination of the Loan Agreement or the Revolving Line prior to the two year anniversary of the Effective Date, the Company must pay a termination fee of 1.00% of the Revolving Line, subject to certain exceptions. On February 18, 2025, the Company entered into a First Amendment (the “Amendment”) to the Loan Agreement. The Amendment provides for, among other things, a new term loan facility (the “Term Loan”) to the Company of up to $3,000,000, available to the Company until February 28, 2026. Advances under the Term Loan (collectively, the “Term Loan Advances”) will be payable in 36 equal monthly installments of principal plus interest, commencing on March 1, 2026, and to the extent not paid, all remaining obligations will become due and payable on February 1, 2029. Term Loan Advances shall accrue interest at a floating rate per annum equal to the greater of (a) 5.0% or (b) the “prime rate,” as published from time to time in the money rates section of the Wall Street Journal, minus 1.0%. At the Company’s option, the Company may prepay all outstanding borrowings under the Term Loan, plus accrued and unpaid interest thereon, subject to a prepayment premium ranging from 1.0% to 3.0%, depending on the year of prepayment. The Term Loan also provides for an end of term charge equal to 2.50% of the aggregate principal amount of any loans prepaid or repaid, as applicable. The Amendment also makes certain changes to the Company’s revolving line of credit under the Loan Agreement, including (i) increasing the defined limit for concentration of Medicare receivables that may be included as “eligible accounts” under the Loan Agreement, and (ii) increasing the permitted aggregate maximum balance that may be maintained in the Company’s German subsidiary. The Company recorded approximately $199,500 in debt origination costs during the year ended December 31, 2024 in conjunction with entering into the Loan Agreement, which includes the commitment fee and the Anniversary Fee. The Company capitalized the debt origination costs and is amortizing them into interest expense using the interest rate method, which approximates straight-line amortization over the term of the Loan Agreement. As of March 31, 2025, the balance of debt origination costs was approximately $165,400, which is included in other long-term assets on the condensed consolidated balance sheet. The Company amortized approximately $29,000 of debt origination costs to interest expense during the three months ended March 31, 2025. Approximately $216,600 was available to be drawn under the Loan Agreement based on eligible accounts receivable as of March 31, 2025. No amounts were drawn under the Revolving Line or the Term Loan under the Loan Agreement as of March 31, 2025.
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.25.1
Stock Award Plans and Stock-based Compensation
|
3 Months Ended |
Mar. 31, 2025 |
Share-Based Payment Arrangement [Abstract] |
|
Stock Award Plans and Stock-based Compensation |
Note 9 — Stock Award Plans and Stock-Based Compensation As of March 31, 2025, there were 1,819,933 shares available for issuance under the Myomo, Inc. 2018 Stock Option and Incentive Plan (the “2018 Plan”). On January 1 of each year, the number of shares of common stock reserved and available for issuance under the 2018 Plan will cumulatively increase by 4% of the number shares of common stock outstanding on the immediately preceding December 31 or such lesser number of shares of common stock determined by management in consultation with members of the Board of Directors, including the compensation committee of the Board of Directors. On January 1, 2025, 1,375,130 shares were added to the share reserve under the 2018 Plan. Recipients of awards of restricted stock units typically sell shares in the open market to cover their individual tax liabilities and remit the proceeds to the Company, which offsets withholding taxes paid by the Company. In certain circumstances, stock awards may be net share settled upon vesting to cover the required employee statutory withholding taxes and the remaining amount is converted into shares based upon their share-value on the date the award vests. In such instances, these payments of employee withholding taxes are presented in the statements of cash flows as a financing activity. There were no stock awards that were net share settled during the three months ended March 31, 2025 and 2024, respectively. Share-Based Compensation Expense The Company accounts for stock awards to employees and non-employees based upon the fair value of the award on the date of grant. The fair value of that award is then ratably recognized as expense over the period during which the recipient is required to provide services in exchange for that award. The Company attributes the value of stock-based compensation to operations on the straight-line method such that the expense associated with awards is evenly recognized over the vesting period. The Company recognized stock-based compensation expense related to the issuance of stock option awards and restricted stock units to employees, non-employees and directors in the statements of operations as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2025 |
|
|
2024 |
|
Cost of goods sold |
|
$ |
41,718 |
|
|
$ |
23,387 |
|
Research and development |
|
|
78,155 |
|
|
|
24,245 |
|
Selling, clinical, and marketing |
|
|
80,239 |
|
|
|
46,121 |
|
General and administrative |
|
|
340,092 |
|
|
|
226,535 |
|
Total |
|
$ |
540,204 |
|
|
$ |
320,288 |
|
As of March 31, 2025, there was approximately $2,900 of unrecognized compensation cost related to unvested stock options that is expected to be recognized over a weighted-average period of 0.48 years. As of March 31, 2025, there was approximately $1,944,000 of unrecognized compensation expense related to unvested restricted stock units that is expected to be recognized over a weighted-average period of 2.20 years.
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.25.1
Commitments and Contingencies
|
3 Months Ended |
Mar. 31, 2025 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
Note 10 — Commitments and Contingencies Litigation The Company may be involved from time to time in legal proceedings, claims and assessments arising from the ordinary course of business. Such matters are subject to many uncertainties, and outcomes are not predictable with assurance. There are no material claims, assessments or litigation against the Company as of March 31, 2025. Operating Leases The Company had a lease agreement for its corporate headquarters in Boston, Massachusetts, which expired in January 2025 and has a lease agreement for office space in Fort Worth, TX. which expires in December 2025. In August 2024, the Company entered into a lease agreement for a new corporate headquarters and manufacturing facility in Burlington, Massachusetts. The Company began relocating operations in December 2024 and completed the move in January 2025. The term of the lease is 88 months following the rent commencement date, which will be May 11, 2025. The Company has the option to extend the new lease for an additional five years, subject to certain conditions being satisfied. Under the new lease, the Company provided a security deposit to the landlord in the form of a letter of credit for $375,000. The Company has collateralized the letter of credit with cash in a separate bank account, which is accounted for as long-term restricted cash on the condensed consolidated balance sheet. Termination options are either not included, or have expired, for the Company’s other existing operating leases. Certain arrangements have discounted rent periods or escalating rent payment provisions. Leases with an initial term of twelve months or less are not recorded on the consolidated balance sheets. We recognize rent expense on a straight-line basis over the lease term. As of March 31, 2025, operating lease assets were approximately $7,295,700. The amount and the maturity of the Company’s operating lease liabilities as of March 31, 2025, are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
2025 |
|
|
|
|
|
|
|
$ |
622,094 |
|
2026 |
|
|
|
|
|
|
|
|
1,168,752 |
|
2027 |
|
|
|
|
|
|
|
|
1,522,500 |
|
2028 |
|
|
|
|
|
|
|
|
1,584,678 |
|
Thereafter |
|
|
|
|
|
|
|
|
6,511,404 |
|
Total future minimum lease payments |
|
|
|
|
|
|
|
|
11,409,428 |
|
Less imputed interest |
|
|
|
|
|
|
|
|
3,138,818 |
|
Total operating lease liabilities |
|
|
|
|
|
|
|
$ |
8,270,610 |
|
Included in the condensed consolidated balance sheet: |
|
|
|
|
|
|
|
|
|
Current operating lease liabilities |
|
|
|
|
|
|
|
$ |
765,616 |
|
Non-current operating lease liabilities |
|
|
|
|
|
|
|
|
7,504,994 |
|
Total operating lease liabilities |
|
|
|
|
|
|
|
$ |
8,270,610 |
|
For the three months ended March 31, 2025 and 2024, the total lease cost is comprised of the following amounts:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
|
|
|
|
2025 |
|
|
2024 |
|
Operating lease expense |
|
|
|
|
|
$ |
401,809 |
|
|
$ |
89,496 |
|
Short-term lease expense |
|
|
|
|
|
|
1,722 |
|
|
|
- |
|
Total lease expense |
|
|
|
|
|
$ |
403,531 |
|
|
$ |
89,496 |
|
The following summarizes additional information related to operating leases:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
Weighted-average remaining lease term (in years) |
|
|
|
|
|
|
7.6 |
|
|
|
7.8 |
|
Weighted-average discount rate |
|
|
|
|
|
|
8.6 |
% |
|
|
8.6 |
% |
Supplier Finance Program Obligations The Company finances its directors and officers insurance policy, which requires the Company to make a down payment, followed by equal payments over a defined term. During the year ended December 31, 2023, the Company entered into a policy covering the twelve-month period ending June 2024. Under this financing arrangement, the Company made nine equal monthly payments of approximately $27,000, starting in July 2023. During the year ended December 31, 2024, the Company completed its payment obligation associated with its 2023-2024 policy and entered into a new policy covering the twelve-month period ending in June 2025. Under this new financing arrangement, the Company made a down payment of approximately $39,000 during the three months ended June 30, 2024, and is making nine equal monthly payments of approximately $39,000, starting in July 2024. Changes in the Company's supplier finance obligations were as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2025 |
|
|
2024 |
|
Opening January 1 |
|
$ |
181,256 |
|
|
$ |
142,217 |
|
Payments |
|
|
— |
|
|
|
— |
|
Expensed |
|
|
98,508 |
|
|
|
80,109 |
|
Ending |
|
$ |
82,748 |
|
|
$ |
62,108 |
|
No assets are pledged as security under this arrangement.
|
X |
- References
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.25.1
Segment Reporting and Major Customers
|
3 Months Ended |
Mar. 31, 2025 |
Segment Reporting [Abstract] |
|
Segment Reporting and Major Customers |
Note 11 — Segment Reporting and Major Customers Segment Reporting ACS 280, “Segment Reporting” establishes standards for reporting information about operating segments on a basis consistent with the Company’s internal organization structure as well as information about products, business segments, and major customers in financial statements. The Company conducts its business in one operating segment, and sells products in one family, which are versions of the MyoPro. While the Company has several sales channels and operates in different geographies, the Chief Executive Officer, who is the Company's chief operating decision-maker, and is responsible for allocating resources and assessing the performance of the Company, manages the Company's business on a consolidated basis, focusing on revenue, gross margin, certain operating expenses, loss from operations, other expenses (income), Income Tax, and Net loss. The Chief Executive Officer reviews the consolidated balance sheet with relation to consolidated Assets. The Chief Executive Officer does not review any additional or more disaggregated level.
|
|
|
|
|
|
|
|
|
For the three months ended March 31, |
|
2025 |
|
|
2024 |
|
Revenue |
|
|
|
|
|
|
Product Revenue |
|
$ |
9,831,814 |
|
|
$ |
3,754,389 |
|
|
|
|
9,831,814 |
|
|
|
3,754,389 |
|
|
|
|
|
|
|
|
Cost of revenue |
|
|
3,222,184 |
|
|
|
1,455,345 |
|
Gross profit |
|
|
6,609,630 |
|
|
|
2,299,044 |
|
Gross margin |
|
|
67.2 |
% |
|
|
61.2 |
% |
Operating expenses: |
|
|
|
|
|
|
Payroll and benefits expense |
|
|
5,257,082 |
|
|
|
3,441,559 |
|
Advertising |
|
|
1,609,688 |
|
|
|
787,250 |
|
All other segment operating expenses |
|
|
4,488,315 |
|
|
|
2,565,432 |
|
Payroll and benefits expense in cost of revenue |
|
|
(1,225,201 |
) |
|
|
(606,430 |
) |
|
|
|
10,129,884 |
|
|
|
6,187,811 |
|
Loss from operations |
|
$ |
(3,520,254 |
) |
|
$ |
(3,888,767 |
) |
Other expense (income) |
|
|
(191,991 |
) |
|
|
(135,293 |
) |
Income Tax Expense |
|
|
136,795 |
|
|
|
82,158 |
|
Net Loss |
|
$ |
(3,465,058 |
) |
|
$ |
(3,835,632 |
) |
Major Customers For the three months ended March 31, 2025 and 2024, there were no customers which accounted for more than 10% of product revenues. For the three months ended March 31, 2025, CMS represented 59% of product revenues. For the three months ended March 31, 2024, a U.S. insurance payer represented 32% of product revenues. At March 31, 2025, CMS and a U.S. commercial insurer and its affiliates accounted for approximately 46% and 12% of accounts receivable, respectively. At December 31, 2024, CMS and a U.S. commercial insurer and its affiliates accounted for approximately 36% and 19% of accounts receivable, respectively. For the three months ended March 31, 2025 and 2024, approximately 17% and 38% of the Company's product revenues, respectively, were derived from patients with Medicare Advantage insurance plans.
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- DefinitionThe entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.
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v3.25.1
Subsequent Events
|
3 Months Ended |
Mar. 31, 2025 |
Subsequent Events [Abstract] |
|
Subsequent Events |
Note 12 — Subsequent Events The Company evaluated subsequent events through the date the financial statements were issued, and determined that there have been no subsequent events that would require recognition in the financial statements or disclosure in the notes to the unaudited condensed consolidated financial statements.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.25.1
Summary of Significant Accounting Policies (Policies)
|
3 Months Ended |
Mar. 31, 2025 |
Accounting Policies [Abstract] |
|
Interim Financial Statements |
Interim Financial Statements The accompanying unaudited condensed consolidated financial statements and notes are representations of the Company’s management, who are responsible for their integrity and objectivity. These statements have been prepared in accordance with United States generally accepted accounting principles ("U.S. GAAP") for interim financial information pursuant to Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for annual financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) that are considered necessary for a fair presentation of the condensed consolidated financial statements of the Company as of March 31, 2025 and for the three months ended March 31, 2025 and 2024. The results of operations for the three months ended March 31, 2025 are not necessarily indicative of the operating results for the fiscal year ending December 31, 2025, or any other period. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related disclosures of the Company as of December 31, 2024 and 2023 and for the years then ended, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.
|
Basis of Consolidation |
Basis of Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary Myomo Europe GmbH. All significant intercompany balances and transactions are eliminated.
|
Comprehensive Income (Loss) |
Comprehensive Income (Loss) Comprehensive loss includes all changes in equity during a period, except those resulting from investments by stockholders and distributions to stockholders. The Company's comprehensive loss includes changes in foreign currency translation adjustments and unrealized gains and losses on short term investments. There was a reclassification which management does not consider to be material out of accumulated other comprehensive income (loss) to other (income) expense related to realized gains or losses on short-term investments in the three months ended March 31, 2025. There were no reclassifications in the three months ended March 31, 2024.
|
Use of Estimates |
Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America require management to make estimates and assumptions that affect certain reported amounts and disclosures. These estimates and assumptions are reviewed on an on-going basis and updated as appropriate. Actual results could differ from these estimates. The Company’s estimates include assertion of collectability with payers where the Company has no contracts as it relates to timing of revenue recognition and discount rate of leases.
|
Cash, Cash Equivalents and Short-Term Investments |
Cash, Cash Equivalents and Short-Term Investments The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents consist principally of deposit accounts and money market accounts at March 31, 2025 and December 31, 2024. The Company considers all investments with an original maturity of greater than three months but less than one year to be short-term investments. Short-term investments as of March 31, 2025 and December 31, 2024 consists of U.S. Treasury Bills and U.S. Government Agency Bills, which are classified as held-to-maturity, totaling approximately $1,760,500 and $493,000 as of March 31, 2025, and December 31, 2024, respectively. The Company determines the appropriate balance sheet classification of its investments at the time of purchases and evaluates the classification at each balance sheet date. All of the Company's U.S. Treasury Bills mature within the subsequent twelve months from the date of purchase. The Company’s cash balances as of March 31, 2025 and December 31, 2024 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
Cash and cash equivalents |
|
$ |
19,793,799 |
|
|
$ |
24,372,373 |
|
Restricted cash |
|
|
375,000 |
|
|
|
375,000 |
|
Total cash, cash equivalents, and restricted cash |
|
$ |
20,168,799 |
|
|
$ |
24,747,373 |
|
|
Accounts Receivable and Allowance for Credit Losses |
Accounts Receivable and Allowance for Credit Losses The Company reports accounts receivable at invoiced amounts less an allowance for credit losses accounts. The Company evaluates its accounts receivable on a continuous basis and, if necessary, establishes an allowance for credit losses based on a number of factors, including current credit conditions and customer payment history. The Company does not require collateral or accrue interest on accounts receivable and credit terms are generally 30 days. At March 31, 2025, and December 31, 2024, the Company recorded an allowance for credit losses accounts of approximately $107,900 and $56,300, respectively.
|
Revenue Recognition |
Revenue Recognition The Company accounts for revenue under ASC 606, “Revenue from Contracts with Customers” and all of the related amendments (Topic 606). Revenues under Topic 606 are required to be recognized either at a “point in time” or “over time,” depending on the facts and circumstances of the arrangement and are evaluated using a five-step model. Generally, the Company recognizes revenue at a point in time. The Company recognizes revenue after applying the following five steps: 1)Identification of the contract, or contracts, with a customer, 2)Identification of the performance obligations in the contract, including whether they are distinct within the context of the contract, 3)Determination of the transaction price, including the constraint on variable consideration, 4)Allocation of the transaction price to the performance obligations in the contract, and 5)Recognition of revenue when, or as, performance obligations are satisfied. Revenue is recognized when control of these services is transferred to our customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those services. Product Revenue Increasingly, the Company derives its revenue from direct billing. The Company also derives revenue from the sale of its products to O&P providers in the United States and internationally and the Veterans Administration (“VA”). Under direct billing, the Company recognizes revenue when all of the following criteria are met: (i)The product has been delivered to the patient, including completion of initial instruction on its use, (ii)Collection is deemed probable and it has been determined that a significant reversal of the revenue to be recognized is not deemed probable when the uncertainty associated with the variable consideration is resolved. As an example, the Company will record revenue if it is notified that insurance intends to pay and a payment amount is provided, and (iii)The amount to be collected is estimable using the “expected value” estimation techniques, or the “most likely amount” as defined in ASC 606. For revenue derived from patients with Medicare Part B, the Company recognizes revenue upon delivery of the device to the patient based on the published fees by the Centers for Medicare & Medicaid Services ("CMS"). With respect to patients with Medicare Advantage or other commercial insurance, for payers where the Company either has a contract or in the absence of a contract, has demonstrated sufficient payment history, the Company will recognize revenue when it receives a pre-authorization from the insurance company and control passes to the patient upon delivery of the device in an amount that reflects the consideration the Company expects to receive in exchange for the device. During the three months ended March 31, 2025 and 2024, the Company made such a determination for certain insurers. These insurers represented approximately 13% and 54% of direct billing channel revenue for the three months ended March 31, 2025 and 2024, respectively. In cases where the Company is the direct provider and it does not have sufficient collection history with the payer, the Company recognizes revenue when payment is received, as then all of the revenue recognition criteria have been met. Depending on the timing of product deliveries to customers, which is when cost of revenue must be recorded, and when the Company meets the criteria to record revenue, there may be fluctuations in gross margin. During the three months ended March 31, 2025 and 2024, the Company recognized revenue of approximately $836,100 and $963,400, respectively, from third-party payers for which costs related to the completion of the Company’s performance obligations were not recorded in the current period. For revenues derived from O&P providers and the VA, the Company recognizes revenue when control passes to the customer in an amount that reflects the consideration the Company expects to receive in exchange for those services. Revenues may be recognized upon shipment or upon delivery, depending on the terms of the arrangement, provided that persuasive evidence of an arrangement exists, there are no uncertainties regarding customer acceptance and collectability is deemed probable. The Company has elected to record taxes collected from customers on a net basis and does not include tax amounts in revenue or cost of revenue. Contract Balances The timing of revenue recognition may differ from the timing of payment by customers. The Company records a receivable when revenue is recognized prior to payment and there is an unconditional right to payment. Alternatively, when payment precedes the provision of the related services, the Company records deferred revenue until the performance obligations are satisfied. The Company had deferred revenue of approximately $129,900 and $83,100 as of March 31, 2025 and December 31, 2024, respectively. Disaggregated Revenue from Contracts with Customers The following table presents revenue by major source:
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
2025 |
|
|
2024 |
|
Direct to patient |
|
$ |
7,807,777 |
|
|
$ |
2,234,742 |
|
Clinical/Medical providers |
|
|
2,024,037 |
|
|
|
1,519,647 |
|
Total revenue from contracts with customers |
|
$ |
9,831,814 |
|
|
$ |
3,754,389 |
|
Geographic Data The Company generated 87% of its total revenue from the United States, 13% from Germany, and less than 1% from other international locations for the three months ended March 31, 2025. The Company generated 75% of its total revenue from the United States, 22% from Germany, and 3% from other international locations, for the three months ended March 31, 2024. Cost of Revenue In conjunction with the adoption of ASC 606, there are certain cases in which the Company will expense costs when incurred as required by ASC 340-40-25. In certain cases, the Company provides the MyoPro device directly to patients, pending reimbursement from third-party payers, after which revenue is recognized. For the three months ended March 31, 2025 and 2024, the Company recorded cost of goods sold of approximately $32,400 and $112,100, respectively, without corresponding revenue. Direct billing fees paid to O&P providers for services they provide in conjunction with patient evaluations are expensed as incurred as required by ASC 340-40-25. These costs are recorded as sales and marketing expense. Internal costs incurred and fees paid to O&P providers to measure, fit and deliver the device to patients are expensed to cost of revenue.
|
Advertising |
Advertising The Company charges the costs of advertising to operating expenses as incurred. Advertising expense amounted to approximately $1,609,700 and $787,200 during the three months ended March 31, 2025 and 2024, respectively.
|
Foreign Currency Translation |
Foreign Currency Translation The functional currency of the Company’s foreign subsidiary, Myomo Europe GmbH, is the Euro. Foreign exchange translation gains and losses from the Euro to U.S. dollars are included in other comprehensive gain. The Company recorded a comprehensive loss of approximately $102,100 and comprehensive income of approximately $63,800 during the three months ended March 31, 2025 and 2024, respectively, which are included in accumulated other comprehensive loss in the condensed consolidated balance sheet. Transaction and translation foreign exchange gains and losses from a foreign currency to the functional currency are included in cost of revenue in the condensed consolidated statements of operations. Such amounts were immaterial for the three months ended March 31, 2025 and 2024. The balance sheet is translated using the spot rate on the day of reporting and the statement of operations is translated monthly using the average rate for the month.
|
Net Loss per Share |
Net Loss per Share Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding, plus potentially dilutive common shares. Restricted stock, restricted stock units, stock options and warrants are excluded from the diluted net loss per share calculation when their impact is antidilutive. The Company reported a net loss for the three months ended March 31, 2025 and 2024, and as a result, all potentially dilutive common shares are considered antidilutive for these periods. Potential dilutive common shares issuable consist of the following at:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
2025 |
|
|
2024 |
|
Stock options |
|
|
22,383 |
|
|
|
23,929 |
|
Restricted stock units |
|
|
1,190,511 |
|
|
|
1,197,626 |
|
Other warrants |
|
|
— |
|
|
|
668,250 |
|
Total |
|
|
1,212,894 |
|
|
|
1,889,805 |
|
Due to their nominal exercise price of $0.0001 per share, a total of 7,061,519 and 8,496,249 outstanding pre-funded warrants as of March 31, 2025 and 2024, respectively, are considered common stock equivalents and are included in weighted average shares outstanding in the accompanying condensed consolidated statements of operations as of the respective closing dates of the Company's public equity offerings.
|
Recently Adopted Accounting Standards |
Recently Adopted Accounting Standards In October 2023, the FASB issued ASU 2023-06, “Disclosure Improvements, Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative”, that adds 14 of the 27 identified disclosure or presentation requirements to the Codification, each amendment in the ASU will only become effective if the SEC removes the related disclosure or presentation from its existing regulations by June 30, 2027. The Company currently complies with these disclosure requirements as applicable under Regulation S-X or Regulation S-K and will adopt these new standards depending on timing of when they become effective, which is not expected to have a material impact on its financial position and results of operations. In December 2023, the FASB issued ASU 2023-09, “Accounting Standards Update, Income Taxes (Topic 740: Improvements to Income Tax Disclosures”. ASU 2023-09 focuses on income tax disclosures around effective tax rates and cash income taxes paid. This amendment in the ASU will become effective for public companies as of December 15, 2024 and effective to all other companies as of December 15, 2025. The Company will adopt these new standards when they become effective, which is not expected to have a material impact on its financial position and results of operations.
|
X |
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v3.25.1
Summary of Significant Accounting Policies (Tables)
|
3 Months Ended |
Mar. 31, 2025 |
Accounting Policies [Abstract] |
|
Schedule of Restricted Cash and Cash Equivalents |
The Company’s cash balances as of March 31, 2025 and December 31, 2024 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
Cash and cash equivalents |
|
$ |
19,793,799 |
|
|
$ |
24,372,373 |
|
Restricted cash |
|
|
375,000 |
|
|
|
375,000 |
|
Total cash, cash equivalents, and restricted cash |
|
$ |
20,168,799 |
|
|
$ |
24,747,373 |
|
|
Summary of Revenue by Major Source |
The following table presents revenue by major source:
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
2025 |
|
|
2024 |
|
Direct to patient |
|
$ |
7,807,777 |
|
|
$ |
2,234,742 |
|
Clinical/Medical providers |
|
|
2,024,037 |
|
|
|
1,519,647 |
|
Total revenue from contracts with customers |
|
$ |
9,831,814 |
|
|
$ |
3,754,389 |
|
|
Summary of Potential Common Shares Issuable |
Potential dilutive common shares issuable consist of the following at:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
2025 |
|
|
2024 |
|
Stock options |
|
|
22,383 |
|
|
|
23,929 |
|
Restricted stock units |
|
|
1,190,511 |
|
|
|
1,197,626 |
|
Other warrants |
|
|
— |
|
|
|
668,250 |
|
Total |
|
|
1,212,894 |
|
|
|
1,889,805 |
|
|
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v3.25.1
Inventories (Tables)
|
3 Months Ended |
Mar. 31, 2025 |
Inventory Disclosure [Abstract] |
|
Schedule of Inventories |
Inventories consist of the following at:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
Finished goods |
|
$ |
1,294,662 |
|
|
$ |
1,289,368 |
|
Work in process |
|
|
98,518 |
|
|
|
60,731 |
|
Parts and subassemblies |
|
|
1,975,322 |
|
|
|
1,815,866 |
|
Inventories, net |
|
$ |
3,368,502 |
|
|
$ |
3,165,965 |
|
|
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v3.25.1
Fair Value of Financial Instruments (Tables)
|
3 Months Ended |
Mar. 31, 2025 |
Fair Value Disclosures [Abstract] |
|
Schedule of Cash Equivalents Measured at Fair Value on Recurring Basis |
Cash equivalents and short-term investments measured at fair value on a recurring basis at March 31, 2025 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In Active Markets for Identical Assets or Liabilities (Level 1) |
|
|
Significant Other Observable Inputs (Level 2) |
|
|
Significant Unobservable Inputs (Level 3) |
|
|
Total |
|
Money market funds |
|
$ |
18,359,786 |
|
|
|
— |
|
|
|
— |
|
|
$ |
18,359,786 |
|
Short-term investments |
|
$ |
— |
|
|
$ |
1,730,460 |
|
|
$ |
— |
|
|
$ |
1,730,460 |
|
Cash equivalents and short-term investments measured at fair value on a recurring basis at December 31, 2024 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In Active Markets for Identical Assets or Liabilities (Level 1) |
|
|
Significant Other Observable Inputs (Level 2) |
|
|
Significant Unobservable Inputs (Level 3) |
|
|
Total |
|
Money market funds |
|
$ |
23,334,374 |
|
|
|
— |
|
|
|
— |
|
|
$ |
23,334,374 |
|
Short-term investments |
|
|
— |
|
|
$ |
492,990 |
|
|
|
— |
|
|
$ |
492,990 |
|
|
X |
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v3.25.1
Accounts Payable and Other Accrued Expenses (Tables)
|
3 Months Ended |
Mar. 31, 2025 |
Payables and Accruals [Abstract] |
|
Summary of Accounts Payable and Other Accrued Expenses |
Accounts Payable and Other Accrued Expenses consists of the following at:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
Trade payables |
|
$ |
2,488,829 |
|
|
$ |
1,169,901 |
|
Accrued compensation and benefits |
|
|
4,830,562 |
|
|
|
5,009,385 |
|
Accrued professional services |
|
|
109,844 |
|
|
|
54,257 |
|
Warranty reserve |
|
|
139,409 |
|
|
|
129,615 |
|
Customer deposits |
|
|
2,774,665 |
|
|
|
2,194,804 |
|
Accrued insurance |
|
|
— |
|
|
|
128,556 |
|
Other |
|
|
105,256 |
|
|
|
335,299 |
|
|
|
$ |
10,448,565 |
|
|
$ |
9,021,817 |
|
|
X |
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v3.25.1
Stock Award Plans and Stock-based Compensation (Tables)
|
3 Months Ended |
Mar. 31, 2025 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Stock-based Compensation Expense |
The Company recognized stock-based compensation expense related to the issuance of stock option awards and restricted stock units to employees, non-employees and directors in the statements of operations as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2025 |
|
|
2024 |
|
Cost of goods sold |
|
$ |
41,718 |
|
|
$ |
23,387 |
|
Research and development |
|
|
78,155 |
|
|
|
24,245 |
|
Selling, clinical, and marketing |
|
|
80,239 |
|
|
|
46,121 |
|
General and administrative |
|
|
340,092 |
|
|
|
226,535 |
|
Total |
|
$ |
540,204 |
|
|
$ |
320,288 |
|
|
X |
- DefinitionTabular disclosure of cost recognized for award under share-based payment arrangement by plan. Includes, but is not limited to, related tax benefit.
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|
v3.25.1
Commitments and Contingencies (Tables)
|
3 Months Ended |
Mar. 31, 2025 |
Commitments and Contingencies Disclosure [Abstract] |
|
Summary of Maturity of Operating Lease Liabilities |
The amount and the maturity of the Company’s operating lease liabilities as of March 31, 2025, are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
2025 |
|
|
|
|
|
|
|
$ |
622,094 |
|
2026 |
|
|
|
|
|
|
|
|
1,168,752 |
|
2027 |
|
|
|
|
|
|
|
|
1,522,500 |
|
2028 |
|
|
|
|
|
|
|
|
1,584,678 |
|
Thereafter |
|
|
|
|
|
|
|
|
6,511,404 |
|
Total future minimum lease payments |
|
|
|
|
|
|
|
|
11,409,428 |
|
Less imputed interest |
|
|
|
|
|
|
|
|
3,138,818 |
|
Total operating lease liabilities |
|
|
|
|
|
|
|
$ |
8,270,610 |
|
Included in the condensed consolidated balance sheet: |
|
|
|
|
|
|
|
|
|
Current operating lease liabilities |
|
|
|
|
|
|
|
$ |
765,616 |
|
Non-current operating lease liabilities |
|
|
|
|
|
|
|
|
7,504,994 |
|
Total operating lease liabilities |
|
|
|
|
|
|
|
$ |
8,270,610 |
|
|
Summary of Operating Lease Cost |
For the three months ended March 31, 2025 and 2024, the total lease cost is comprised of the following amounts:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
|
|
|
|
2025 |
|
|
2024 |
|
Operating lease expense |
|
|
|
|
|
$ |
401,809 |
|
|
$ |
89,496 |
|
Short-term lease expense |
|
|
|
|
|
|
1,722 |
|
|
|
- |
|
Total lease expense |
|
|
|
|
|
$ |
403,531 |
|
|
$ |
89,496 |
|
|
Summary of Additional Information Related to Operating Leases |
The following summarizes additional information related to operating leases:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
Weighted-average remaining lease term (in years) |
|
|
|
|
|
|
7.6 |
|
|
|
7.8 |
|
Weighted-average discount rate |
|
|
|
|
|
|
8.6 |
% |
|
|
8.6 |
% |
|
Schedule Of Changes In The Companys Supplier Finance Obligations |
Changes in the Company's supplier finance obligations were as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2025 |
|
|
2024 |
|
Opening January 1 |
|
$ |
181,256 |
|
|
$ |
142,217 |
|
Payments |
|
|
— |
|
|
|
— |
|
Expensed |
|
|
98,508 |
|
|
|
80,109 |
|
Ending |
|
$ |
82,748 |
|
|
$ |
62,108 |
|
|
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v3.25.1
Segment Reporting and Major Customers (Tables)
|
3 Months Ended |
Mar. 31, 2025 |
Segment Reporting [Abstract] |
|
Schedule of focusing on revenue, gross margin and certain operating expenses |
Company, manages the Company's business on a consolidated basis, focusing on revenue, gross margin, certain operating expenses, loss from operations, other expenses (income), Income Tax, and Net loss. The Chief Executive Officer reviews the consolidated balance sheet with relation to consolidated Assets. The Chief Executive Officer does not review any additional or more disaggregated level.
|
|
|
|
|
|
|
|
|
For the three months ended March 31, |
|
2025 |
|
|
2024 |
|
Revenue |
|
|
|
|
|
|
Product Revenue |
|
$ |
9,831,814 |
|
|
$ |
3,754,389 |
|
|
|
|
9,831,814 |
|
|
|
3,754,389 |
|
|
|
|
|
|
|
|
Cost of revenue |
|
|
3,222,184 |
|
|
|
1,455,345 |
|
Gross profit |
|
|
6,609,630 |
|
|
|
2,299,044 |
|
Gross margin |
|
|
67.2 |
% |
|
|
61.2 |
% |
Operating expenses: |
|
|
|
|
|
|
Payroll and benefits expense |
|
|
5,257,082 |
|
|
|
3,441,559 |
|
Advertising |
|
|
1,609,688 |
|
|
|
787,250 |
|
All other segment operating expenses |
|
|
4,488,315 |
|
|
|
2,565,432 |
|
Payroll and benefits expense in cost of revenue |
|
|
(1,225,201 |
) |
|
|
(606,430 |
) |
|
|
|
10,129,884 |
|
|
|
6,187,811 |
|
Loss from operations |
|
$ |
(3,520,254 |
) |
|
$ |
(3,888,767 |
) |
Other expense (income) |
|
|
(191,991 |
) |
|
|
(135,293 |
) |
Income Tax Expense |
|
|
136,795 |
|
|
|
82,158 |
|
Net Loss |
|
$ |
(3,465,058 |
) |
|
$ |
(3,835,632 |
) |
|
X |
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v3.25.1
Liquidity - Additional Information (Detail) - USD ($)
|
|
|
3 Months Ended |
|
|
|
Dec. 06, 2024 |
Jan. 19, 2024 |
Mar. 31, 2025 |
Mar. 31, 2024 |
Feb. 18, 2025 |
Dec. 31, 2024 |
Jul. 11, 2024 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
Net loss |
|
|
$ 3,465,100
|
$ 3,835,600
|
|
|
|
Accumulated deficit |
|
|
|
106,575,600
|
|
$ 103,114,500
|
|
Cash used in operating activities |
|
|
$ 2,676,900
|
$ 3,245,600
|
|
|
|
Sale of stock number of shares issued in transaction |
3,450,000
|
1,354,218
|
|
|
|
|
|
Sales of prefunded warrants |
|
224,730
|
7,061,519
|
|
|
|
|
Price per share |
$ 5
|
$ 3.8
|
|
|
|
|
|
Per sale price of warrants |
|
$ 3.7999
|
|
|
|
|
|
Sale of stock consideration received on transaction |
$ 15,800,000
|
$ 5,400,000
|
|
|
|
|
|
Amount borrowed against account receivable |
|
|
|
|
|
|
$ 4,000,000
|
Loan And Security Agreement [Member] |
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
Line Of Credit Facility Maximum Borrowing Capacity |
|
|
|
|
$ 3,000,000
|
|
|
Maximum [Member] |
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
Line Of Credit Facility Maximum Borrowing Capacity |
|
|
$ 216,600
|
|
|
|
|
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v3.25.1
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($)
|
3 Months Ended |
|
Mar. 31, 2025 |
Mar. 31, 2024 |
Dec. 31, 2024 |
Summary of Significant Accounting Policies [Line Items] |
|
|
|
Deferred revenue |
$ 129,900
|
|
$ 83,100
|
Cost of goods sold |
32,400
|
$ 112,100
|
|
Advertising expense |
1,609,700
|
787,200
|
|
Restructuring Reserve, Foreign Currency Translation Gain (Loss) |
$ 102,100
|
$ 63,800
|
|
Warrants exercise price |
$ 0.0001
|
|
|
Common stock equivalents, pre-funded warrants |
7,061,519
|
8,496,249
|
|
Short-Term Investments |
$ 1,760,500
|
|
493,000
|
Allowance for credit losses |
$ 107,900
|
|
$ 56,300
|
Percentage of direct billing channel revenue Payers represent |
13.00%
|
54.00%
|
|
Product Revenue [Member] | Geographic Concentration Risk [Member] | United States |
|
|
|
Summary of Significant Accounting Policies [Line Items] |
|
|
|
Percentage of revenue |
87.00%
|
75.00%
|
|
Product Revenue [Member] | Geographic Concentration Risk [Member] | Germany [Member] |
|
|
|
Summary of Significant Accounting Policies [Line Items] |
|
|
|
Percentage of revenue |
13.00%
|
22.00%
|
|
Product Revenue [Member] | Geographic Concentration Risk [Member] | Other International Locations [Member] |
|
|
|
Summary of Significant Accounting Policies [Line Items] |
|
|
|
Percentage of revenue |
1.00%
|
3.00%
|
|
O&P Providers or Third Party Payors [Member] |
|
|
|
Summary of Significant Accounting Policies [Line Items] |
|
|
|
Revenue recognized |
$ 836,100
|
$ 963,400
|
|
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v3.25.1
Summary of Significant Accounting Policies - Schedule of Restricted Cash and Cash Equivalents (Details) - USD ($)
|
Mar. 31, 2025 |
Dec. 31, 2024 |
Restricted Cash and Cash Equivalents [Abstract] |
|
|
Cash and cash equivalents |
$ 19,793,799
|
$ 24,372,373
|
Restricted cash |
375,000
|
375,000
|
Total cash, cash equivalents, and restricted cash |
$ 20,168,799
|
$ 24,747,373
|
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v3.25.1
Summary of Significant Accounting Policies - Summary of Revenue by Major Source (Detail) - USD ($)
|
3 Months Ended |
Mar. 31, 2025 |
Mar. 31, 2024 |
Disaggregation of Revenue [Line Items] |
|
|
Total revenue from contracts with customer |
$ 9,831,814
|
$ 3,754,389
|
Direct to Patient [Member] |
|
|
Disaggregation of Revenue [Line Items] |
|
|
Total revenue from contracts with customer |
7,807,777
|
2,234,742
|
Clinical/Medical Providers [Member] |
|
|
Disaggregation of Revenue [Line Items] |
|
|
Total revenue from contracts with customer |
$ 2,024,037
|
$ 1,519,647
|
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v3.25.1
Summary of Significant Accounting Policies - Summary of Potential Common Shares Issuable (Detail) - shares
|
3 Months Ended |
Mar. 31, 2025 |
Mar. 31, 2024 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
1,212,894
|
1,889,805
|
Employee Stock Option |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
22,383
|
23,929
|
Restricted Stock Units [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
1,190,511
|
1,197,626
|
Other Warrants [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
0
|
668,250
|
X |
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v3.25.1
Inventories - Schedule of Inventories (Detail) - USD ($)
|
Mar. 31, 2025 |
Dec. 31, 2024 |
Inventory Disclosure [Abstract] |
|
|
Finished goods |
$ 1,294,662
|
$ 1,289,368
|
Work in process |
98,518
|
60,731
|
Parts and subassemblies |
1,975,322
|
1,815,866
|
Inventories, net |
$ 3,368,502
|
$ 3,165,965
|
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v3.25.1
Fair Value of Financial Instruments - Schedule of Cash Equivalents Measured at Fair Value on Recurring Basis (Detail) - USD ($)
|
Mar. 31, 2025 |
Dec. 31, 2024 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] |
|
|
Cash equivalents |
$ 18,359,786
|
$ 23,334,374
|
Short-term investments |
1,730,460
|
492,990
|
In Active Markets for Identical Assets or Liabilities (Level 1) [Member] | Money market funds [Member] |
|
|
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] |
|
|
Cash equivalents |
18,359,786
|
23,334,374
|
Significant Other Observable Inputs (Level 2) [Member] |
|
|
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] |
|
|
Short-term investments |
$ 1,730,460
|
$ 492,990
|
X |
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v3.25.1
Accounts Payable and Other Accrued Expenses - Summary of Accounts Payable and Other Accrued Expenses (Detail) - USD ($)
|
Mar. 31, 2025 |
Dec. 31, 2024 |
Payables and Accruals [Abstract] |
|
|
Trade payables |
$ 2,488,829
|
$ 1,169,901
|
Accrued compensation and benefits |
4,830,562
|
5,009,385
|
Accrued professional services |
109,844
|
54,257
|
Warranty reserve |
139,409
|
129,615
|
Customer deposits |
2,774,665
|
2,194,804
|
Accrued insurance |
0
|
128,556
|
Other |
105,256
|
335,299
|
Total |
$ 10,448,565
|
$ 9,021,817
|
X |
- DefinitionAccrued liabilities customer deposit.
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v3.25.1
Common Stock and Warrants - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions |
|
|
3 Months Ended |
Dec. 06, 2024 |
Jan. 19, 2024 |
Mar. 31, 2025 |
Mar. 31, 2024 |
Class of Stock [Line Items] |
|
|
|
|
Sale of stock number of shares issued in transaction |
3,450,000
|
1,354,218
|
|
|
Sales of prefunded warrants |
|
224,730
|
7,061,519
|
|
Per Sale Price of warrants |
|
$ 3.7999
|
|
|
Sale Of Stock Consideration Received On Transaction |
$ 15.8
|
$ 5.4
|
|
|
Nominal Exercise Value |
|
$ 0.0001
|
$ 0.0001
|
|
SalesOfPrefundedWarrants |
|
224,730
|
7,061,519
|
|
Investor warrants issued |
|
|
668,250
|
|
Price per share |
$ 5
|
$ 3.8
|
|
|
Exercise of stock options, shares |
|
|
0
|
0
|
A T M Facility [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Exercise of stock options, shares |
|
|
708
|
0
|
Common Stock | Restricted Stock [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Number of shares, Vested |
|
|
59,031
|
300,544
|
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v3.25.1
Line of Credit (Additional Information) (Details) - USD ($)
|
|
|
3 Months Ended |
12 Months Ended |
|
Feb. 18, 2025 |
Jul. 11, 2024 |
Mar. 31, 2025 |
Dec. 31, 2024 |
Aug. 31, 2024 |
Line of Credit Facility [Line Items] |
|
|
|
|
|
Long term line of credit |
|
|
|
|
$ 375,000
|
Maximum [Member] |
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
Amount drawn under loan agreement |
|
|
$ 216,600
|
|
|
Loan And Security Agreement [Member] |
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
Percentage of amounts advanced |
|
80.00%
|
|
|
|
Floating interest rate |
|
0.50%
|
|
|
|
Commitment fee |
|
$ 20,000
|
|
|
|
Anniversary fee |
|
0.50%
|
|
|
|
Termination fee |
|
0.01
|
|
|
|
Amount drawn under loan agreement |
$ 3,000,000
|
|
|
|
|
Debt issuance costs |
|
|
|
$ 199,500
|
|
Debt origination cost balance |
|
|
165,400
|
|
|
Expensed of debt origination costs |
|
|
29,000
|
|
|
Loan And Security Agreement [Member] | Maximum [Member] |
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
Floating interest rate |
|
8.50%
|
|
|
|
Revolving Credit Facility [Member] |
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
Long term line of credit |
|
|
$ 0
|
|
|
Revolving Credit Facility [Member] | Loan And Security Agreement [Member] |
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
Long term line of credit |
|
$ 4,000,000
|
|
|
|
Anniversary fee |
|
0.50%
|
|
|
|
Revolving Credit Facility [Member] | Loan And Security Agreement [Member] | Maximum [Member] |
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
Long term line of credit |
|
$ 5,500,000
|
|
|
|
Term Loan [Member] | Silicon Valley Bank [Member] |
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
Floating interest rate |
5.00%
|
|
|
|
|
Amount drawn under loan agreement |
$ 3,000,000
|
|
|
|
|
Debt instrument maturity date |
Feb. 28, 2026
|
|
|
|
|
Monthly installment period |
36
|
|
|
|
|
Debt instrument, interest rate, stated percentage |
1.00%
|
|
|
|
|
Percentage of aggregate principal amount |
2.50%
|
|
|
|
|
Term Loan [Member] | Silicon Valley Bank [Member] | Maximum [Member] |
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
Floating interest rate |
3.00%
|
|
|
|
|
Term Loan [Member] | Silicon Valley Bank [Member] | Minimum [Member] |
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
Floating interest rate |
1.00%
|
|
|
|
|
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- DefinitionThe carrying value as of the balance sheet date of the current and noncurrent portions of long-term obligations drawn from a line of credit, which is a bank's commitment to make loans up to a specific amount. Examples of items that might be included in the application of this element may consist of letters of credit, standby letters of credit, and revolving credit arrangements, under which borrowings can be made up to a maximum amount as of any point in time conditional on satisfaction of specified terms before, as of and after the date of drawdowns on the line. Includes short-term obligations that would normally be classified as current liabilities but for which (a) postbalance sheet date issuance of a long term obligation to refinance the short term obligation on a long term basis, or (b) the enterprise has entered into a financing agreement that clearly permits the enterprise to refinance the short-term obligation on a long term basis and the following conditions are met (1) the agreement does not expire within 1 year and is not cancelable by the lender except for violation of an objectively determinable provision, (2) no violation exists at the BS date, and (3) the lender has entered into the financing agreement is expected to be financially capable of honoring the agreement.
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Stock Award Plans and Stock-based Compensation - Schedule of Stock-based Compensation Expense (Detail) - USD ($)
|
3 Months Ended |
Mar. 31, 2025 |
Mar. 31, 2024 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
Total share based compensation expense |
$ 540,204
|
$ 320,288
|
Cost of Goods Sold [Member] |
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
Total share based compensation expense |
41,718
|
23,387
|
Research and Development [Member] |
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
Total share based compensation expense |
78,155
|
24,245
|
General and Administrative [Member] |
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
Total share based compensation expense |
340,092
|
226,535
|
Selling, clinical, and marketing [Member] |
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
Total share based compensation expense |
$ 80,239
|
$ 46,121
|
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v3.25.1
Commitments and Contingencies - Additional Information (Detail) - USD ($)
|
3 Months Ended |
|
|
|
|
Mar. 31, 2025 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2024 |
Aug. 31, 2024 |
Mar. 31, 2024 |
Dec. 31, 2023 |
Commitments And Contingencies [Line Items] |
|
|
|
|
|
|
|
Description of operating lease agreement for office space |
The Company had a lease agreement for its corporate headquarters in Boston, Massachusetts, which expired in January 2025 and has a lease agreement for office space in Fort Worth, TX. which expires in December 2025. In August 2024, the Company entered into a lease agreement for a new corporate headquarters and manufacturing facility in Burlington, Massachusetts. The Company began relocating operations in December 2024 and completed the move in January 2025. The term of the lease is 88 months following the rent commencement date, which will be May 11, 2025. The Company has the option to extend the new lease for an additional five years, subject to certain conditions being satisfied. Under the new lease, the Company provided a security deposit to the landlord in the form of a letter of credit for $375,000. The Company has collateralized the letter of credit with cash in a separate bank account, which is accounted for as long-term restricted cash on the condensed consolidated balance sheet. Termination options are either not included, or have expired, for the Company’s other existing operating leases. Certain arrangements have discounted rent periods or escalating rent payment provisions. Leases with an initial term of twelve months or less are not recorded on the consolidated balance sheets. We recognize rent expense on a straight-line basis over the lease term.
|
|
|
|
|
|
|
Lessee, Operating Lease, Term of Contract |
|
|
|
|
88 months
|
|
|
Lessee, Operating Lease, Option to Extend |
The Company has the option to extend the new lease for an additional five years, subject to certain conditions being satisfied.
|
|
|
|
|
|
|
Long term line of credit |
|
|
|
|
$ 375,000
|
|
|
Operating Lease Right Of Use Assets |
$ 7,295,700
|
|
|
|
|
|
|
Finance program obligations |
$ 82,748
|
|
|
$ 181,256
|
|
$ 62,108
|
$ 142,217
|
Directors and Officers Insurance Member |
|
|
|
|
|
|
|
Commitments And Contingencies [Line Items] |
|
|
|
|
|
|
|
Finance program obligations |
|
$ 39,000
|
|
|
|
|
|
Debt Instrument, Periodic Payment |
|
$ 39,000
|
$ 27,000
|
|
|
|
|
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v3.25.1
Commitments and Contingencies - Summary of Maturity of Operating Lease Liabilities (Detail) - USD ($)
|
Mar. 31, 2025 |
Dec. 31, 2024 |
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] |
|
|
2025 |
$ 622,094
|
|
2026 |
1,168,752
|
|
2027 |
1,522,500
|
|
2028 |
1,584,678
|
|
Thereafter |
6,511,404
|
|
Total future minimum lease payments |
11,409,428
|
|
Less imputed interest |
3,138,818
|
|
Total operating lease liabilities |
8,270,610
|
|
Included in the condensed consolidated balance sheet: |
|
|
Current operating lease liability |
765,616
|
$ 748,021
|
Non-current operating lease liability |
7,504,994
|
$ 7,358,184
|
Total operating lease liabilities |
$ 8,270,610
|
|
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v3.25.1
Segment Reporting and Major Customers - Schedule of focusing on revenue, gross margin and certain operating expenses (Details) - USD ($)
|
3 Months Ended |
Mar. 31, 2025 |
Mar. 31, 2024 |
Segment Reporting Information [Line Items] |
|
|
Revenue |
$ 9,831,814
|
$ 3,754,389
|
Cost of revenue |
3,222,184
|
1,455,345
|
Gross profit |
6,609,630
|
2,299,044
|
Operating expenses: |
|
|
Advertising |
1,609,700
|
787,200
|
Total operating expenses |
10,129,884
|
6,187,811
|
Loss from operations |
(3,520,254)
|
(3,888,767)
|
Other expense (income) |
191,991
|
135,293
|
Income tax expense |
136,795
|
82,158
|
Net Income (Loss) |
(3,465,058)
|
(3,835,632)
|
Segment Reporting |
|
|
Segment Reporting Information [Line Items] |
|
|
Revenue |
9,831,814
|
3,754,389
|
Cost of revenue |
3,222,184
|
1,455,345
|
Gross profit |
$ 6,609,630
|
$ 2,299,044
|
Gross margin |
67.20%
|
61.20%
|
Operating expenses: |
|
|
Payroll and benefits expense |
$ 5,257,082
|
$ 3,441,559
|
Advertising |
1,609,688
|
787,250
|
All other segment operating expenses |
4,488,315
|
2,565,432
|
Payroll and benefits expense in cost of revenue |
(1,225,201)
|
(606,430)
|
Total operating expenses |
10,129,884
|
6,187,811
|
Loss from operations |
(3,520,254)
|
(3,888,767)
|
Other expense (income) |
(191,991)
|
(135,293)
|
Income tax expense |
136,795
|
82,158
|
Net Income (Loss) |
(3,465,058)
|
(3,835,632)
|
Product revenue |
|
|
Segment Reporting Information [Line Items] |
|
|
Revenue |
9,831,814
|
3,754,389
|
Product revenue | Segment Reporting |
|
|
Segment Reporting Information [Line Items] |
|
|
Revenue |
$ 9,831,814
|
$ 3,754,389
|
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