CEDAR KNOLLS, N.J.,
Nov. 14, 2018 /PRNewswire/ -- MYOS
RENS Technology Inc. ("MYOS" or "the Company") (NASDAQ: MYOS), a
bionutrition company and owner of Fortetropin®,
the natural food product that helps build lean muscle in
conjunction with resistance training, announced today its financial
results for the three and nine months ended September 30, 2018 and business updates.
BUSINESS HIGHLIGHTS:
On November 8, MYOS announced that it signed a
distribution agreement with Miller Veterinary Supply East
("Miller"), which will allow MYOS to sell its MYOS Canine
Muscle Formula™ ("Myos Canine") in more than 6,000
veterinary hospitals. Miller began marketing Myos Canine at the New
York Vet conference on November 8,
attended by veterinarians from around the globe. Myos Canine
was well received by all, including holistic veterinarians, who
were impressed with the "single-ingredient" product.
On October 2, MYOS announced that
MYOS Enteral Nutrition Formula™, formulated with
Fortetropin, became eligible for Medicare and Medicaid
reimbursement, as it was approved as an HCPCS B4150 Product after
review by the Pricing, Data Analysis, and Coding Contractor for the
Centers for Medicare and Medicaid Services. This HCPCS B4150
code is used to describe enteral formulas which are nutritionally
complete with intact nutrients, including proteins, fats,
carbohydrates, vitamins, and minerals. Securing Medicare and
Medicaid reimbursement widens the spectrum of patients who could
gain access to our product, and we believe such reimbursement will
encourage clinicians to utilize the product in their practices.
Collegiate Sports Marketing with IMG
IMG College, a
division of IMG, has successfully engaged numerous universities
throughout the country to use MYOS' 'NSF Certified for Sport'
all-natural sports nutrition product
Yolked®, formulated with
Fortetropin. MYOS has partnered with IMG to market and
promote Yolked, which has been clinically shown to help the body
build lean muscle. IMG College represents more than 200 colleges
for multimedia rights, licensing and sponsorships.
CLINICAL RESEARCH HIGHLIGHTS:
In April 2017, MYOS entered into an agreement with
the College of Veterinary Medicine at Kansas
State University to study the impact of
Fortetropin® on reducing muscle atrophy in dogs after
tibial-plateau-leveling osteotomy (TPLO) repair surgery. The study
is expected to be completed by the end of the first quarter of
2019.
In December 2017, MYOS entered
into an agreement with the University of
California, Berkeley's Department of Nutritional Sciences
& Toxicology to study the effects of Fortetropin® on
increasing the fractional rate of skeletal muscle protein synthesis
in men and women between 60 and 75 years of age. The study and
proteomics and data analyses are expected to be completed by the
second quarter of 2019.
In March 2018, MYOS entered into a
research discovery program with Rutgers
University, The State University of New Jersey, to engage Rutgers researchers in discovering compounds and
products based on Fortetropin for improving muscle health and
performance.
In May 2018, MYOS entered into an
agreement for a pre-clinical cachexia study with Weill Cornell
Medical Center focusing on the efficacy of Fortetropin in
preventing weight and muscle loss associated with cancer in a mouse
model of lung cancer. We anticipate that the study will be
completed, and the results announced around the end of the second
quarter of 2019.
FINANCIAL HIGHLIGHTS: (Amounts in thousands except
where noted.)
Third Quarter 2018:
Net revenues
decreased 59% to $66 for the three
months ended September 30, 2018,
compared to $160 for the three months
ended September 30, 2017. The
decrease in net revenues was primarily due to the non-recurring
sale to Cenegenics of $100 in 2017
and a $13 decrease in sales from our
older products (QURR, RE & PMHF), offset by a $21 increase from new products launched in 2018,
including Yolked and MYOS Canine Muscle Formula.
Gross profit for the three months ended September 30, 2018 decreased 93% to $7, compared to $95
for the three months ended September 30,
2017. Gross profit margin for the three months ended
September 30, 2018 was 11%, compared
to 59% for the three months ended September
30, 2017.
Operating expenses for the three months ended September 30, 2018, increased 7% to $916 compared to $852 for the three months ended September 30, 2017.
Net loss increased 21% to $911 for
the three months ended September 30,
2018 compared to $753 for the
three months ended September 30,
2017.
Nine Months ended September 30,
2018:
Net revenues decreased to $211 for the nine months ended September 30, 2018, compared to $369 for the nine months ended September 30, 2017. The decrease in net revenues
of $158 was primarily due to a
one-time non-recurring sale of $116
to a related party and $100 of net
revenues for our non-recurring sale to Cenegenics in the nine
months ended September 30, 2017. This
was offset by an increase of $58 in
net revenues in all of our current product lines.
Gross profit for the nine months ended September 30, 2018 decreased 51% to $61, compared to $125 for the nine months ended September 30, 2017. Gross profit margin for the
nine months ended September 30, 2018
was 29% compared to 34% for the nine months ended September 30, 2017.
Operating expenses for the nine months ended September 30, 2018 increased 3% to $3,216, compared to $3,113 for the nine months ended September 30, 2017.
Net loss increased 6% to $3,158
for the nine months ended September 30,
2018 compared to $2,976 for
the nine months ended September 30,
2017.
Liquidity
As of September 30,
2018, the Company had cash of $459 and total assets of $4,003, and $1,155
in working capital. Net cash used in operating activities for the
nine months ended September 30, 2018
was $2,550, a decrease of
$650 compared to $3,200 for the nine months ended September 30, 2017.
Promissory Note
On August 30,
2018, the Company executed an unsecured promissory note in
the principal amount of $750 in favor
of Joseph Mannello, the Company's
chief executive officer. Interest accrues at a rate of 5% per
annum. Funds drawn are payable within one year. On November 13, 2018, the Company amended and
restated the note to increase the maximum amount that may be drawn
down from $750 to $1,000. The proceeds of the note will be used by
the Company for general working capital purposes.
MANAGEMENT COMMENTARY:
Joseph
Mannello, Chief Executive Officer of MYOS,
commented, "We had a productive quarter as we continue to make
progress in executing on our business plan. Our sports nutrition
segment continues to receive great feedback from IMG, as well as
from the universities we've introduced Yolked to, as we anticipate
the formal launch of Yolked to the public very soon.
"One of our key pillars of growth has been the launch of our
veterinary segment and our MYOS Canine Muscle
Formula. Last week, MYOS announced our first distribution
agreement for MYOS Canine with Miller Veterinary Supply East, which
will allow for greater exposure to more than 6,000 veterinary
hospitals. We've received positive feedback and testimonials from
our initial customers, along with industry participants we've
engaged with at industry trade show events. We believe MYOS Canine
represents a significant growth opportunity for the Company.
"We were delighted to gain approval for our new MYOS
Enteral Nutrition Formula, formulated with Fortetropin, for
Medicare and Medicaid reimbursement. We continue to believe in the
therapeutic potential of Fortetropin and are committed to finding
the optimal development pathways forward. Our team of scientists
continue to explore the development and commercialization of
medical nutrition products, a long-term initiative that we believe
will enable us to further leverage the versatility of
Fortetropin.
"We are committed to continuing our focus on our clinical
research studies, which underpins our commercial strategy for
Fortetropin, and enhances our intellectual property assets. We
currently have three clinical studies and one ongoing pre-clinical
study, and anticipate launching additional clinical studies over
the next several months. Overall, I'm excited about the progress we
made during the third quarter, as we continued to leverage
Fortetropin across our sports nutrition, veterinary, and
therapeutics divisions. We believe our branding development efforts
will help generate positive results as we expand our product
distribution efforts. We look forward to sharing more on our
developing story in the months to come," concluded Mr.
Mannello.
CONFERENCE CALL
MYOS will host a conference call on
Thursday, November 15, 2018 at
10:30am ET, at which time MYOS Chief
Executive Officer Joseph Mannello
will provide commentary for the third quarter and provide an update
on the business and its ongoing clinical studies.
Call Date/Time: Thursday, November 15, 2018 at 10:30am ET
Call Title:
MYOS RENS Technology Third
Quarter 2018 Results Conference Call
Dial
In:
877-407-4019 from the U.S.; international callers may telephone
201-689-8337,
approximately
15 minutes before the call.
A digital replay will be available by telephone approximately
two hours after the completion of the call until February 9, 2019 and may be accessed by dialing
877-660-6853 from the U.S. or 201-612-7415 for international
callers, using the Conference ID# 13684940.
This call will be simultaneously webcast. The webcast will be
available on the MYOS website, www.myosrens.com, in the "Investor
Relations" section. The webcast will be archived and available at
the same web address.
About MYOS RENS Technology Inc.
MYOS RENS
Technology Inc. (MYOS), "The Muscle Company®", is a
Cedar Knolls, NJ-based
bionutrition company that develops and markets products that
improve muscle health and performance. MYOS is the owner of
Fortetropin®, a fertilized egg yolk-based product
manufactured via a proprietary process to retain and optimize its
biological activity. Fortetropin has been clinically shown to
increase muscle size and lean body mass in conjunction with
resistance training. MYOS believes Fortetropin has the potential to
redefine existing standards of physical health and wellness. For
more information, please visit www.myosrens.com.
Forward-Looking Statements
Any statements in
this release that are not historical facts are forward-looking
statements. Actual results may differ materially from those
projected or implied in any forward-looking statements. Such
statements involve risks and uncertainties, including but not
limited to those relating to product and customer demand, market
acceptance of our products, the ability to create new products
through research and development, the successful results of
strategic initiatives, the successful launch of our products,
including Qurr®, Yolked®, MYOS
Enteral Nutrition Formula™ and MYOS Canine
Muscle Formula™ products, the success of our research
and development, including the clinical studies described above,
the results of the clinical evaluation of
Fortetropin® and its effects, the ability to
enter into new partnership opportunities and the success of our
existing partnerships, the ability to generate revenue and cash
flow from sales of our products, the ability to increase our
revenue and gross profit margins, the ability to achieve a
sustainable, profitable business, the effect of economic
conditions, the ability to protect our intellectual property
rights, competition from other providers and products, the
continued listing of our securities on the Nasdaq Stock Market,
risks in product development, our ability to raise capital to fund
continuing operations, and other factors discussed from time to
time in our filings with the Securities and Exchange
Commission. We undertake no obligation to update or revise any
forward-looking statement for events or circumstances after
the date on which such statement is made except as required by
law.
These statements have not been evaluated by the Food and
Drug Administration. Our products are not intended to
diagnose, treat, cure or prevent any disease.
The following tables should be read in conjunction with the
footnotes accompanying the consolidated financial statements
contained in the Quarterly Report on Form 10-Q previously filed
with the Securities and Exchange Commission.
MYOS RENS
TECHNOLOGY INC. AND SUBSIDIARY CONDENSED CONSOLIDATED
BALANCE SHEETS (in thousands, except share and per share
amounts)
|
|
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2018
|
|
|
2017
|
|
|
|
(Unaudited)
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
|
|
$
|
459
|
|
|
$
|
923
|
|
Accounts receivable,
net
|
|
|
5
|
|
|
|
4
|
|
Inventories,
net
|
|
|
1,741
|
|
|
|
1,779
|
|
Prepaid expenses and
other current assets
|
|
|
108
|
|
|
|
163
|
|
Total current
assets
|
|
|
2,313
|
|
|
|
2,869
|
|
Deferred offering
costs
|
|
|
108
|
|
|
|
102
|
|
Fixed assets,
net
|
|
|
157
|
|
|
|
184
|
|
Intangible assets,
net
|
|
|
1,425
|
|
|
|
1,640
|
|
Total
assets
|
|
$
|
4,003
|
|
|
$
|
4,795
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
169
|
|
|
$
|
176
|
|
Accrued expenses and
other current liabilities
|
|
|
237
|
|
|
|
255
|
|
Promissory note
payable and accrued interest
|
|
|
752
|
|
|
|
-
|
|
Total current
liabilities
|
|
|
1,158
|
|
|
|
431
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
1,158
|
|
|
|
431
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred stock,
$.001 par value; 500,000 shares authorized; no shares issued and
outstanding
|
|
|
-
|
|
|
|
-
|
|
Common
stock, $.001 par value; 12,000,000 shares authorized at September
30, 2018 and at December 31, 2017; 7,473,723 and
6,340,604 shares issued and outstanding at September 30, 2018 and
December 31, 2017, respectively
|
|
|
7
|
|
|
|
6
|
|
Additional paid-in
capital
|
|
|
37,840
|
|
|
|
36,202
|
|
Accumulated
deficit
|
|
|
(35,002)
|
|
|
|
(31,844)
|
|
Total stockholders'
equity
|
|
|
2,845
|
|
|
|
4,364
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
4,003
|
|
|
$
|
4,795
|
|
MYOS RENS
TECHNOLOGY INC. AND SUBSIDIARY CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited; in thousands,
except share and per share amounts)
|
|
|
|
|
|
Three Months
Ended
|
|
|
Nine Months
Ended
|
|
|
|
September
30,
|
|
|
September
30,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
revenues
|
|
$
|
66
|
|
|
$
|
160
|
|
|
$
|
211
|
|
|
$
|
369
|
|
Cost of
sales
|
|
|
59
|
|
|
|
65
|
|
|
|
150
|
|
|
|
244
|
|
Gross
profit
|
|
|
7
|
|
|
|
95
|
|
|
|
61
|
|
|
|
125
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, marketing
and research
|
|
|
128
|
|
|
|
91
|
|
|
|
756
|
|
|
|
599
|
|
Personnel and
benefits
|
|
|
396
|
|
|
|
309
|
|
|
|
1,162
|
|
|
|
1,053
|
|
General and
administrative
|
|
|
392
|
|
|
|
452
|
|
|
|
1,298
|
|
|
|
1,461
|
|
Total operating
expenses
|
|
|
916
|
|
|
|
852
|
|
|
|
3,216
|
|
|
|
3,113
|
|
Operating
loss
|
|
|
(909)
|
|
|
|
(757)
|
|
|
|
(3,155)
|
|
|
|
(2,988)
|
|
Other
income
|
|
|
-
|
|
|
|
5
|
|
|
|
-
|
|
|
|
13
|
|
Interest
expense
|
|
|
(2)
|
|
|
|
(1)
|
|
|
|
(3)
|
|
|
|
(1)
|
|
Net loss
|
|
$
|
(911)
|
|
|
$
|
(753)
|
|
|
$
|
(3,158)
|
|
|
$
|
(2,976)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common shareholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
$
|
(0.12)
|
|
|
$
|
(0.13)
|
|
|
$
|
(0.45)
|
|
|
$
|
(0.52)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
7,473,723
|
|
|
|
5,844,372
|
|
|
|
7,077,499
|
|
|
|
5,736,637
|
|
MYOS RENS
TECHNOLOGY INC. AND SUBSIDIARY CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS (Unaudited; in
thousands)
|
|
|
|
|
|
Nine Months
Ended
|
|
|
|
September
30,
|
|
|
|
2018
|
|
|
2017
|
|
Cash Flows From
Operating Activities:
|
|
|
|
|
|
|
Net loss
|
|
$
|
(3,158)
|
|
|
$
|
(2,976)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
27
|
|
|
|
39
|
|
Amortization
|
|
|
215
|
|
|
|
196
|
|
Stock-based
compensation
|
|
|
195
|
|
|
|
121
|
|
Deferred offering
costs
|
|
|
96
|
|
|
|
-
|
|
Bad debt
expense
|
|
|
-
|
|
|
|
59
|
|
Inventory
reserve
|
|
|
25
|
|
|
|
-
|
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
|
(Increase) decrease
in accounts receivable
|
|
|
(1)
|
|
|
|
(107)
|
|
Decrease in
inventories, net
|
|
|
13
|
|
|
|
41
|
|
Decrease (increase)
in prepaid expenses
|
|
|
55
|
|
|
|
(415)
|
|
Decrease in deferred
revenue
|
|
|
-
|
|
|
|
(46)
|
|
Decrease in accounts
payable and accrued interest and other expenses
|
|
|
(17)
|
|
|
|
(112)
|
|
Net cash used in
operating activities
|
|
|
(2,550)
|
|
|
|
(3,200)
|
|
|
|
|
|
|
|
|
|
|
Cash Flows From
Financing Activities:
|
|
|
|
|
|
|
|
|
Deferred offering
costs from at-the-market transaction
|
|
|
(108)
|
|
|
|
(125)
|
|
Proceeds from
promissory note payable
|
|
|
750
|
|
|
|
-
|
|
Proceeds from
registered direct offering of common stock, net of costs
|
|
|
1,444
|
|
|
|
1,927
|
|
Net cash provided by
financing activities
|
|
|
2,086
|
|
|
|
1,802
|
|
|
|
|
|
|
|
|
|
|
Net decrease in
cash
|
|
|
(464)
|
|
|
|
(1,398)
|
|
Cash at beginning of
period
|
|
|
923
|
|
|
|
1,866
|
|
Cash at end of
period
|
|
$
|
459
|
|
|
$
|
468
|
|
|
|
|
|
|
|
|
|
|
Supplemental
schedule of non-cash investing and financing
activities:
|
|
|
|
|
|
|
|
|
Recognition of
deferred offering costs as a reduction of equity in connection with
the at-the-market offering
|
|
$
|
6
|
|
|
$
|
-
|
|
Investor Relations:
Porter LeVay & Rose
Michael Porter, President
Phone: 212-564-4700
Email: MYOS@plrinvest.com
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SOURCE MYOS RENS Technology Inc.