MELA Sciences Announces Fourth Quarter and Year End 2012 Financial Results
IRVINGTON, N.Y., March 5, 2013 (GLOBE NEWSWIRE) -- MELA Sciences, Inc.
(Nasdaq:MELA), the medical device company that has developed and is
commercializing MelaFind^®, today announced financial results for the fourth
quarter and year ended December 31, 2012.
Fourth Quarter 2012 Performance Highlights:
*Accelerated our rate of signed user agreements, system placements, and the
training of new customers in connection with our controlled and deliberate
launch of MelaFind in the US and in several key cities throughout Germany.
*Obtained signed user agreements for 115 MelaFind systems in the US and
Germany by the end of the fourth quarter.
*Ended the fourth quarter with 95 MelaFind systems installed in
dermatologists' offices in the US and Germany and continue to work with
customers to train and assist them in using MelaFind appropriately in
order to incorporate its use successfully into their practices.
*Entered into discussions with over 100 additional dermatologist
practices that either have a user agreement currently under evaluation,
or have been classified as "highly interested" by the Company as of
*Expanded and enhanced commercial sales presence.
*Added territory managers with extensive dermatology sales experience,
and as of the fourth quarter, have eight territory managers in the US
and four in Germany. Expanded the team of Practice Support managers to
five managers in the US and one in Germany to focus on practice-wide
adoption of MelaFind.
*Embarked upon several initiatives to promote patient awareness and
*Introduced peer to peer videos where dermatologists who are experienced
MelaFind users explain how to best use MelaFind.
*Created and distributed in-office literature, posters and tear sheets
for dermatologists to better educate patients about MelaFind.
*Announced the engagement of Rpr Marketing Communications, a highly
experienced marketing communications agency, singularly focused on
dermatology and skincare.
*MelaFind was designated by the Cleveland Clinic as one of the Top 10
Innovations for 2013 based on its significant clinical impact, high
probability for commercial success, and significant human interest.
*Completed a simultaneous installation of seven MelaFind systems in a large
dermatology practice with over twenty dermatology care providers.
*Trained the entire staff and worked in conjunction with them to launch a
large scale one-week melanoma detection campaign.
*During the campaign, over 344 lesions underwent full MelaFind analysis,
with overall excellent clinical performance in a real world setting.
"As of the end of 2012, we have completed our first nine months on the market
with MelaFind, and are pleased to report that we have escalated the pace of
our commercial activities, consistent with our planned deliberate and
controlled launch of MelaFind in the US and Germany. We are thrilled with the
level of demand we are experiencing and broad based clinician acceptance,"
said Dr. Joseph V. Gulfo, President and CEO of MELA Sciences. "We look forward
to finishing our first year on the market strong and beginning phase two of
our launch with a focus on system usage and patient mobilization with a more
robust base of customers."
"During the American Academy of Dermatology meeting in Miami in early March,
we experienced tremendous booth traffic, with over 650 dermatologists engaging
us to learn more about MelaFind; 350 of which received in-depth
demonstrations. Several dermatologists signed user agreements on site. Many
others obtained additional information to share with their partners and
practice managers at home, as they seriously consider obtaining MelaFind
systems. We believe that this is a testament to the excellent clinical results
and increasing awareness and demand for MelaFind in the community."
"From a financing perspective, we are pleased that we have recently fortified
our balance sheet. Upon closing of our equity offering in Februaryand
consummation of the initial funding of the debt financing in the coming weeks,
together with the remaining $4 million that would be available under the debt
financing contingent on certain performance milestones, the cash committed to
the Company's balance sheetwould beroughly $30 million.We envision being
able to execute the second phase of our launch strategy with confidence
throughout 2013 and well into 2014," said Dr. Joseph V. Gulfo, President and
CEO of MELA Sciences.
MelaFind is the Company's breakthrough non-invasive and objective automated
point of care system for use when a dermatologist chooses to obtain additional
information for a decision to biopsy clinically atypical pigmented skin
lesions with one or more clinical or historical characteristics of melanoma.
Fourth Quarter and 2012 Financial Results
Revenues for the three months ended December 31, 2012 were $122,327 compared
to no revenues reported for the same period in 2011. The Company's net loss
for the three months ended December 31, 2012 was $6.1 million, or $0.19 per
diluted share, compared to a net loss of $4.5 million, or $0.17 per diluted
share, for the same period in 2011.
Revenues for the twelve months ended December 31, 2012 were $278,461 compared
to no revenues reported for the same period in 2011. Deferred revenues
reported as of December 31, 2012 were $303,377 versus no deferred revenue as
of December 31, 2011. Revenues were based on the installation of 95 MelaFind
systems and do not account for the revenue from 20 additional user agreements
signed in the fourth quarter 2012. Deferred revenues reflect the timed
recognition of the installation fee revenue over the term of the user
agreement which is generally two years.
The Company's net loss for the twelve months ended December 31, 2012 was $22.7
million, or $0.74 per diluted share, compared to a net loss of $20.4 million,
or $0.80 per diluted share, for the twelve months ended December 31, 2011. The
increase in the net loss was primarily attributable to Selling, General and
Administrative expenses related to the expansion of the Company's sales force
and the Company's incremental marketing costs as well as the increase in
direct costs associated with the placement of MelaFind systems in
MELA Sciences will host a conference call today at 4:30 PM EST to
discussfourth quarter 2012 quarterly results. To participate in the call,
dial 1-877-303-9205 approximately 10 minutes before the conference call is
scheduled to begin. To listen via live webcast, please go to the investor
relations section of the MELA Sciences website at http://www.melasciences.com
approximately 10 minutes prior to the teleconference start time. If you are
unable to participate during the live conference call and webcast, the
conference call audio cast will be archived and available for replay for
approximately 90 days.
About MELA Sciences, Inc.
MELA Sciences is a medical device company focused on the commercialization of
its flagship product, MelaFind^®, and its further design and development.
MelaFind is a non-invasive tool to provide additional information to
dermatologists during melanoma skin examinations. The device uses light from
visible to near-infrared wavelengths to evaluate skin lesions up to 2.5 mm
beneath the skin. The device provides information on a lesion's level of
morphologic disorganization to provide additional objective information that
may be used by dermatologists in the biopsy decision-making process. MelaFind
has been approved by the US Food and Drug Administration for use in the US. In
addition, MelaFind has received CE Mark approval and is approved for use in
the European Union.
For more information on MELA Sciences, visit www.melasciences.com.
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 other
statements that contain words such as "expects," "contemplates,"
"anticipates," "plans," "intends," "believes," "assumes," "predicts" and
variations of such words or similar expressions that predict or indicate
future events or trends, or that do not relate to historical matters. These
statements are based on our current beliefs or expectations and are inherently
subject to significant known and unknown uncertainties and changes in
circumstances, many of which are beyond our control. There can be no assurance
that our beliefs or expectations will be achieved. Actual results may differ
materially from our beliefs or 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 facing the company such as those set
forth in its reports on Forms 10-Q and 10-K filed with the US Securities and
Exchange Commission (the "SEC"). Factors that might cause such a difference
include whether MelaFind^® achieves market acceptance. Given the uncertainties
affecting companies in the medical device industry such as the Company, any or
all of these forward-looking statements may prove to be incorrect. Therefore,
you should not rely on any such factors or forward-looking statements. The
Company urges you to carefully review and consider the disclosures found in
its filings with the SEC which are available at www.sec.gov and
TABLES TO FOLLOW
MELA SCIENCES, INC.
Cash and cash equivalents $27,996,871 $7,861,524
Accounts receivable — 179,956
Inventory — 675,602
Prepaid expenses and other current assets 1,061,550 965,624
Total Current Assets 29,058,421 9,682,706
Property and equipment, net 1,626,791 7,349,531
Patents and trademarks, net 59,208 47,308
Deferred financing costs 62,391 106,141
Other assets 586,498 84,127
Total Assets $31,393,309 $17,269,813
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable (includes related parties of
$36,027and $59,689 as of December31, 2011and $670,950 $1,850,102
December31, 2012, respectively)
Accrued expenses 745,754 956,541
Deferred revenue — 171,726
Other current liabilities 30,993 40,811
Total Current Liabilities 1,447,697 3,019,180
Long Term Liabilities:
Deferred rent 138,216 143,772
Deferred revenue — 131,651
Total Long Term Liabilities 138,216 275,423
Total Liabilities 1,585,913 3,294,603
COMMITMENTS, CONTINGENCIES and LITIGATION
Preferred stock — $.10 par value; authorized
10,000,000 shares; issued and outstanding: none
Common stock — $.001 par value; authorized
45,000,000 shares; issued and outstanding 30,308 32,205
30,307,538 shares at December31, 2011 and
32,204,720 at December31, 2012
Additional paid-in capital 149,304,424 156,142,873
Accumulated deficit (119,527,336) (142,199,868)
Stockholders' Equity 29,807,396 13,975,210
Total Liabilities and Stockholders' Equity $31,393,309 $17,269,813
MELA SCIENCES, INC.
STATEMENTS OF OPERATIONS
Three months ended Twelve months ended
2012 2011 2012 2011
Revenue $122,327 $— $278,461 $—
Cost of revenue 970,976 — 2,042,333 —
Gross profit (848,649) — (1,763,872) —
Research and 1,285,344 2,021,510 6,791,940 9,656,003
General and 3,953,253 2,515,058 14,168,754 10,806,228
Operating loss (6,087,246) (4,536,568) (22,724,566) (20,462,231)
Interest income (3,803) (9,177) (32,083) (54,371)
Other income (5,001) (5,056) (19,951) (23,145)
Net loss: $(6,078,442) $(4,522,335) $(22,672,532) $(20,384,715)
Basic and diluted
net loss per common $(0.19) $(0.17) $(0.74) $(0.80)
Basic and diluted
weighted average 31,727,391 25,870,908 30,762,610 25,415,880
number of common
MELA SCIENCES, INC.
STATEMENTS OF STOCKHOLDERS' EQUITY
Years Ended December31, 2010, 2011 and 2012
Common Stock Paid-in Accumulated Stockholders'
Shares Amount Capital Deficit Equity
Balance at $
January1, 22,354,317 $ 22,354 109,513,582 $ (79,220,106) $ 30,315,830
Exercise of 12,944 13 33,075 33,088
exercise of 16,262 16 (16) —
Exercise of 239,723 240 1,691,394 1,691,634
exercise of 32,548 33 (33) —
in connection 2,200,000 2,200 15,231,471 15,233,671
with a public
Committed 406,744 407 3,719,697 3,720,104
compensation 727,156 727,156
Net loss (19,922,515) (19,922,515)
December31, 25,262,538 25,263 130,916,326 (99,142,621) 31,798,968
Exercise of 5,000 5 13,345 13,350
common stock 40,000 40 171,960 172,000
in connection 5,000,000 5,000 15,019,662 15,024,662
with a public
compensation 3,183,131 3,183,131
Net loss (20,384,715) (20,384,715)
December31, 30,307,538 30,308 149,304,424 (119,527,336) 29,807,396
exercise of 11,868 12 (12) --
Exercise of 21,484 21 44,738 44,759
in connection 1,863,830 1,864 5,306,173 5,308,037
with an ATM
compensation 1,487,550 1,487,550
Net loss (22,672,532) (22,672,532)
December31, 32,204,720 $32,205 $156,142,873 $(142,199,868) $13,975,210
MELA SCIENCES, INC.
STATEMENTS OF CASH FLOWS
December31, December31, December31,
2010 2011 2012
Cash flows from operating
Net loss $(19,922,515) $(20,384,715) $(22,672,532)
Adjustments to reconcile net loss
to net cash used in operating
Gain on sale of fixed assets (8,811) — —
Depreciation and amortization 552,860 562,803 969,500
Issuance of common stock award — 172,000 —
Write off of unamortized financing — — 62,391
Noncash compensation 727,156 3,183,131 1,487,550
Changes in operating assets and
Increase in accounts receivable — — (179,956)
Increase in inventory — — (675,602)
Decrease (increase) in prepaid 141,290 (537,878) 95,926
expenses and other current assets
(Decrease) increase in accounts (121,321) (239,776) 1,389,939
payable and accrued expenses
(Decrease) increase in other (3,747) 1,455 9,818
Increase in other assets (289,705) (248,793) (19,643)
Increase in deferred rent 104,304 33,912 5,556
Increase in deferred revenue — — 303,377
Net cash used in operating (18,820,489) (17,457,861) (19,223,676)
Cash flows from investing
Purchases of property and (1,044,079) (104,092) (6,158,326)
Proceeds from disposal of fixed 10,284 — —
Net cash used in investing (1,033,795) (104,092) (6,158,326)
Cash flows from financing
Net proceeds from private 15,233,671 15,024,662 5,201,896
Net proceeds from Committed Equity 3,743,283 — —
Proceeds from exercise of stock 33,088 13,350 44,759
Proceeds from exercise of stock 1,691,634 — —
Net cash provided by financing 20,701,676 15,038,012 5,246,655
Net increase (decrease) in cash 847,392 (2,523,941) (20,135,347)
and cash equivalents
Cash and cash equivalents at 29,673,420 30,520,812 27,996,871
beginning of year
Cash and cash equivalents at end $ 30,520,812 $ 27,996,871 $ 7,861,524
Supplemental Schedule of Noncash
Investing and Financing
Amortization of deferred financing $23,179 — $41,179
MelaFind^®components from other — — $522,014
assets to property and equipment
CONTACT: For Investors
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