MELA Sciences Reports Its First Quarter 2014 Business and Financial Results
May 13 2014 - 4:01PM
Marketwired
MELA Sciences Reports Its First Quarter 2014 Business and Financial
Results
Company to Host Conference Call Today at 4:30PM Eastern Time
IRVINGTON, NY--(Marketwired - May 13, 2014) - MELA Sciences,
Inc. (NASDAQ: MELA), developer of the MelaFind® system, an optical
diagnostic device approved for use in the United States and the
European Union to assist dermatologists in melanoma diagnosis,
today announced results for its fiscal 2014 first quarter (Q1'14)
ended March 31, 2014. MELA will host a conference call today at
4:30 pm EDT to review its results and recent progress.
CEO Overview
Rose Crane, President and CEO, commented, "The MELA team made
strong progress the past quarter against our strategic initiatives.
We are focused on key strategies for 2014 and will review these
efforts in greater detail in today's conference call."
The highlights include:
- Introducing the MelaFind system in key medical institutions
where leading dermatologists treat high-risk patients. Most
recently we have expanded our system placements to include Baylor
University, Stanford University and The Ohio State University;
- Conducting further clinical trials to build our research base
and further illustrate the value of the MelaFind system. This
includes our Post-Approval Study now underway and a Predictive
Probability Study conducted with 191 dermatologists that
demonstrated the benefit of our system in the diagnosis of
melanoma;
- Advancing our technology through design enhancements, including
a new user interface introduced in the U.S. and Germany;
- Redirecting our small sales force to focus on key institutions
and physicians as well as areas of high incidence of melanoma, in
addition to moving from a rental-based model to a sales-based
revenue model as previously disclosed, including third-party
medical lease financing to help physicians purchase our
systems;
- Initiating the process to seek insurance reimbursement codes
and status for the MelaFind system, which we believe should become
a significant driver of future system demand; and
- Continuing our disciplined management of cash and our other
resources to best support our key initiatives.
"I am very excited by our technology as I believe it is vital to
the health of thousands," added Ms. Crane. "A person dies every
hour from melanoma, sixteen people are diagnosed every hour and 75%
of all skin cancer deaths are from melanoma. If caught early and
treated, melanoma is curable and MELA Sciences is bringing to
market a powerful new solution in support of this cause."
Financial and Operating Highlights
MELA Sciences reported a Q1'14 net loss of approximately $8.0
million, or $0.16 per share, compared with a net loss of
approximately $6.5 million, or $0.17 per share for the comparable
period last year. Included in the Q1'14 financial results were
liquidated damages of approximately $3.4 million incurred and paid
in connection with the Company's financing completed in February
2014.
Total operating expenses of $3.9 million in Q1'14 declined more
than 29% from Q1'13, with significant declines in both research and
development expenses and selling, general and administrative
expenses. The decrease resulted primarily from salary and headcount
reductions in accordance with the cost reduction plan initiated in
August 2013. The Company intends to institute actions during 2014
that may further reduce its quarterly rate of SG&A expense.
Net revenues and cost of sales were adversely affected during
Q1'14 by the Company's change in business strategy from a
rental-based revenue model to a sales-based revenue model. No
revenue from sales of the MelaFind system were recorded during
Q1'14, however sales contracts signed during the first quarter have
been completed during the second quarter. The Company believes that
once it obtains the necessary reimbursement codes and insurer
approvals revenues from the sales of the MelaFind system could
increase significantly.
Net cash used in operations was approximately $7.1 million in
Q1'14 as compared with approximately $6.1 million in Q1'13. Net
cash used in operations in Q1'14 includes $3.4 million in
liquidated damages paid to investors in connection with the
February 2014 financing.
Liquidity
In connection with the February 2014 financing, MELA granted
registration rights with respect to the shares of common stock
underlying both the Series A Preferred Stock and the warrants
pursuant to the terms of a Registration Rights Agreement. The
investors were entitled to receive liquidated damages upon the
occurrence of a number of events relating to filing, effectiveness
and maintaining an effective registration statement covering the
shares underlying the securities issued in the February financing.
The Company was unable to meet certain filing and effectiveness
requirements and as a result paid approximately $3.4 million in
liquidated damages to the investors.
MELA's cash balance at March 31, 2014 was $8.1 million compared
with $3.8 million at December 31, 2013. The Company believes that
its existing cash on hand and the actions it expects to take to
reduce expenses will support the Company's operations into the
fourth quarter of 2014. The Company continues to assess the effects
of its previously announced cost reduction plan and will reduce
various costs as necessary. The Company will need to raise
additional capital during the upcoming months, the timing and
amount of which will be affected by numerous factors, many of which
are not under its control.
Conference Call and Webcast Details:
Conference Call: 845-675-0437 or 866-519-4004 - Passcode:
42498987
Telephone Replay: 855-452-5696 or 646 254 3697 - Available May
13th - May 21st
Live Webcast & Replay:
www.melasciences.com/investors/home
About MELA Sciences, Inc. www.melasciences.com
MELA Sciences is a medical device company developing dermatology
diagnostics utilizing state-of-the-art optical imaging. The
Company's flagship product is the MelaFind® system, a non-invasive
diagnostic tool to aid dermatologists in melanoma evaluation and
diagnosis, which has secured FDA Pre-Market Approval (PMA) for the
U.S. and CE Marking certification for the European Union. The
MelaFind® system uses a variety of visible to near-infrared light
waves to evaluate skin lesions from the surface to 2.5 mm beneath
the skin. It provides images and data on the relative
disorganization of a lesion's cell structure that provides
substantial additional perspective to aid melanoma diagnosis. MELA
is also exploring new potential uses for its core imaging
technology and algorithms.
Safe Harbor
This press release includes "forward-looking statements" within
the meaning of the Securities Litigation Reform Act of 1995. These
statements include but are not limited to our plans, objectives,
expectations and intentions and may contain words such as "seeks,"
"look forward," and "there seems" that suggest future events or
trends. These statements are based on our current expectations and
are inherently subject to significant uncertainties and changes in
circumstances. Actual results may differ materially from our
expectations due to financial, economic, business, competitive,
market, regulatory and political factors or conditions affecting
the company and the medical device industry in general, as well as
more specific risks and uncertainties set forth in the company's
SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any
or all of these forward-looking statements may prove to be
incorrect or unreliable. MELA Sciences assumes no duty to update
its forward-looking statements and urges investors to carefully
review its SEC disclosures available at www.sec.gov and
www.melasciences.com.
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MELA SCIENCES, INC. |
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BALANCE SHEETS |
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March 31, |
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December 31, |
|
|
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2014 |
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2013 |
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(unaudited) |
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* |
|
ASSETS |
|
Current Assets: |
|
|
|
|
|
|
|
|
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Cash and cash equivalents |
|
$ |
8,122,709 |
|
|
$ |
3,782,881 |
|
|
Accounts receivable (net of allowance of $43,080 and
$46,130 as of March 31, 2014 and December 31, 2013,
respectively) |
|
|
34,121 |
|
|
|
57,151 |
|
|
Inventory (net of reserve of $325,000 as of March 31,
2014 and December 31, 2013) |
|
|
5,648,020 |
|
|
|
5,631,205 |
|
|
Prepaid expenses and other current assets |
|
|
465,140 |
|
|
|
879,698 |
|
|
|
Total
Current Assets |
|
|
14,269,990 |
|
|
|
10,350,935 |
|
|
Property and equipment, net |
|
|
2,995,253 |
|
|
|
3,690,784 |
|
|
Patents and trademarks, net |
|
|
40,526 |
|
|
|
41,795 |
|
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Other assets |
|
|
48,000 |
|
|
|
48,000 |
|
Total Assets |
|
$ |
17,353,769 |
|
|
$ |
14,131,514 |
|
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current Liabilities: |
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Accounts payable (includes related parties of $85,972
and $32,902 as of March 31, 2014 and December 31, 2013,
respectively) |
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$ |
1,311,174 |
|
|
$ |
1,478,995 |
|
|
Accrued expenses (includes related parties of $23,129
and $48,000 as of March 31, 2014 and December 31, 2013,
respectively) |
|
|
819,851 |
|
|
|
844,131 |
|
|
Deferred placement revenue |
|
|
201,864 |
|
|
|
243,605 |
|
|
Warrant liability |
|
|
8,464,865 |
|
|
|
3,017,142 |
|
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Other current liabilities |
|
|
61,815 |
|
|
|
67,934 |
|
|
|
Total
Current Liabilities |
|
|
10,859,569 |
|
|
|
5,651,807 |
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|
|
|
|
|
|
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Long Term Liabilities: |
|
|
|
|
|
|
|
|
|
Deferred placement revenue |
|
|
28,834 |
|
|
|
63,754 |
|
|
Deferred rent |
|
|
110,111 |
|
|
|
120,120 |
|
|
|
Total
Long Term Liabilities |
|
|
138,945 |
|
|
|
183,874 |
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Total Liabilities |
|
|
10,998,514 |
|
|
|
5,835,681 |
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COMMITMENTS AND CONTINGENCIES |
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Stockholders' Equity: |
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Preferred stock - $0.10 par value; authorized
10,000,000 shares: issued and outstanding: 12,300 at March 31, 2014
and 0 at December 31, 2013 |
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1,230 |
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- |
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Common stock - $0.001 par value; authorized 95,000,000
shares: |
|
|
|
|
|
|
|
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Issued and outstanding 52,107,465 shares at March 31,
2014 and 47,501,596 at December 31, 2013 |
|
|
52,108 |
|
|
|
47,502 |
|
|
Additional paid-in capital |
|
|
182,430,391 |
|
|
|
176,396,209 |
|
|
Accumulated deficit |
|
|
(176,128,474 |
) |
|
|
(168,147,878 |
) |
|
|
Total
Stockholders' Equity |
|
|
6,355,255 |
|
|
|
8,295,833 |
|
Total Liabilities and Stockholders' Equity |
|
$ |
17,353,769 |
|
|
$ |
14,131,514 |
|
|
|
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|
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* Derived from the audited balance sheet as of December
31, 2013 |
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MELA SCIENCES, INC. |
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STATEMENTS OF OPERATIONS |
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(unaudited) |
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Three months ended March 31, |
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2014 |
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2013 |
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Net revenues |
|
$ |
97,638 |
|
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$ |
144,100 |
|
Cost of revenue |
|
|
918,523 |
|
|
|
1,080,263 |
|
|
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Gross
profit |
|
|
(820,885 |
) |
|
|
(936,163 |
) |
|
|
|
|
|
|
|
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Operating expenses: |
|
|
|
|
|
|
|
|
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Research and development |
|
|
707,824 |
|
|
|
1,262,001 |
|
|
Selling, general and administrative |
|
|
3,203,533 |
|
|
|
4,287,228 |
|
|
Total operating expenses |
|
|
3,911,357 |
|
|
|
5,549,229 |
|
|
|
Operating loss |
|
|
(4,732,242 |
) |
|
|
(6,485,392 |
) |
|
|
|
|
|
|
|
|
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Other income (expenses): |
|
|
|
|
|
|
|
|
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Interest income |
|
|
618 |
|
|
|
2,105 |
|
|
Interest expense |
|
|
(1,199 |
) |
|
|
(48,763 |
) |
|
Change in fair value of warrant liability |
|
|
137,142 |
|
|
|
15,433 |
|
|
Registration rights liquidated damages |
|
|
(3,389,940 |
) |
|
|
- |
|
|
Other income, net |
|
|
5,025 |
|
|
|
5,000 |
|
|
|
|
(3,248,354 |
) |
|
|
(26,225 |
) |
|
|
|
|
|
|
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Net
loss |
|
$ |
(7,980,596 |
) |
|
$ |
(6,511,617 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(0.16 |
) |
|
$ |
(0.17 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average number of common
shares outstanding |
|
|
48,926,409 |
|
|
|
39,233,943 |
|
|
|
|
|
|
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Media Diana Garcia Redruello MELA Sciences, Inc. 212-518-4226
dgarcia@melasciences.com Investors David Collins, Eric Lentini
Catalyst Global 212-924-9800 mela@catalyst-ir.com
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