MELA Sciences Announces Second Quarter 2012 Financial Results
IRVINGTON, NY, Aug 07, 2012 (MARKETWIRE via COMTEX) -- MELA Sciences, Inc.
(MELA), the medical device company that has developed and is commercializing
MelaFind(R), today announced financial results for the second quarter ended June
30, 2012.
Second Quarter 2012 Performance Highlights:
--Continued its controlled and deliberate launch of MelaFind in the US
and in several key cities throughout Germany.
--The Company ended the second quarter with 25 MelaFind systems in
the field in the US and Germany and continues to work with
customers to train and assist them in using MelaFind appropriately
to incorporate its use successfully into their practices.
--Published positive and highly statistically significant clinical
results of the impact of MelaFind in a German clinical study.
--The study demonstrated that dermatologists, who incorporated
MelaFind into their biopsy decision-making process for the
detection of melanoma at its earliest, most curable stages,
outperformed those who did not have the MelaFind information.
--The study was conducted in collaboration with the German
Cooperative Oncology Group (DeCOG) and German Skin Cancer Society.
It included over two hundred dermatologists.
--Added resources to support the expanding and accelerating commercial
launch and demand for the MelaFind system.
--Continued to build sales, field service, and medical affairs
capabilities, including the addition of four sales people, a
technical support engineer and an Assistant Medical Affairs
Director in the quarter.
--Ramped up contract manufacturing by expanding the utilization of
existing capabilities and adding a new manufacturing bay to
further increase capacity.
"We continued our controlled launch of MelaFind in the US and Germany in the
second quarter and 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. "While we are still in the initial phase of our controlled and
deliberate launch, MelaFind has been put into the offices of over 25
dermatologists in the US and Germany. We are working alongside our initial
dermatologist customers to help them incorporate MelaFind into their practices,
which we believe will, in turn, facilitate wider penetration. We are finalizing
various programs and tactics designed to encourage increased utilization of
installed systems, and we look forward to rolling-out these initiatives in the
coming months."
"We were pleased with the results of the German study, the largest study of its
kind, which were consistent with studies performed with dermatologists in the US.
The clinical data were recently presented by the principal investigator, Dr. Axel
Hauschild, Professor of Dermatology from the University Hospital (UKSH) of Kiel,
Germany, at the 23rd Practical Dermatology & Venereology Conference (FoBi) in
Munich in July," Dr. Gulfo continued.
"Based on the favorable customer experiences and in concert with our plans, we
will now accelerate the pace at which we will be placing MelaFind systems in
dermatologists' offices. We look forward to the Summer American Academy of
Dermatology meeting next week and the American Society of Dermatologic Surgery
meeting in October to engage customers and drive sales. We believe we are on
track to achieve our stated goal of placing 200 systems in the US and 75 in
Germany by the end of 1Q 2013," Dr. Gulfo concluded.
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.
Second Quarter 2012 Financial Results Revenues for the three months ended June
30, 2012 were $75,757 compared to no revenues reported for the same period in
2011 and up from revenues of $11,250 reported in 1Q 2012. Deferred revenues for
the second quarter were $70,724 versus no deferred revenue for 2Q 2011 and up
from $17,250 of deferred revenue in 1Q 2012. Deferred revenues reflect the timed
recognition of the installation fee revenue over the term of the user agreement,
or two years.
The Company's net loss for the three months ended June 30, 2012 was $5.5 million,
or $0.18 per diluted share, compared to a net loss of $4.8 million, or $0.19 per
diluted share, for the same period in 2011. The increase in the net loss was
primarily attributable to an increase in General and Administrative expenses
related to the expansion of the Company's salesforce and the Company's
incremental marketing costs as well as the increase in direct costs associated
with the placement of MelaFind systems in dermatologists' offices.
As of June 30, 2012, the Company's cash and cash equivalents were $17.2 million.
Conference Call MELA Sciences will host a conference call today at 4:30 PM EST to
discuss second quarter 2012 quarterly results. To participate in the call, dial
1-888-240-9345 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 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(R), 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 melasciences.com.
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
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(R) 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 sec.gov and melasciences.com.
MELA SCIENCES, INC.
CONDENSED BALANCE SHEETS
June 30,December 31,
20122011
-----------------------------
(unaudited)*
ASSETS
Current Assets:
Cash and cash equivalents$17,211,098$27,996,871
Accounts receivable68,360-
Inventory473,454-
Prepaid expenses and other current assets664,4631,061,550
-----------------------------
Total Current Assets18,417,37529,058,421
Property and equipment, net3,214,9321,626,791
Patents and trademarks, net53,25859,208
Deferred financing costs-62,391
Deferred public offering cost144,199-
Other assets71,235586,498
-----------------------------
Total Assets$21,900,999$31,393,309
-----------------------------
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable (includes related parties
of $50,000 and $36,027- as of June 30, 2012
and December 31, 2011, respectively)$1,328,742$670,950
Accrued expenses976,775745,754
Deferred revenue (ST)47,334-
Other current liabilities43,27030,993
-----------------------------
Total Current Liabilities2,396,1211,447,697
-----------------------------
Long Term Liabilities:
Deferred rent140,994138,216
Deferred revenue (LT)40,640-
-----------------------------
Total Long Term Liabilities181,634138,216
-----------------------------
Total Liabilities2,577,7551,585,913
-----------------------------
COMMITMENTS, CONTINGENCIES and LITIGATION
(Note 8)
Stockholders' Equity
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
30,332,217 shares at June 30, 2012 and
30,307,538 at December 31, 201130,33230,308
Additional paid-in capital150,057,460149,304,424
Accumulated deficit(130,764,548)(119,527,336)
-----------------------------
Stockholders' Equity19,323,24429,807,396
-----------------------------
Total Liabilities and Stockholders' Equity$21,900,999$31,393,309
-----------------------------
* Derived from the audited balance sheet as of December 31, 2011
MELA SCIENCES, INC.
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
Three months ended June
30,Six months ended June 30,
--------------------------------------------------
2012201120122011
----------------------------------------------
Revenue$75,757$-$87,007$-
Cost of revenue372,048-502,458-
----------------------------------------------
Gross profit(296,291)-(415,451)-
Operating expenses:
Research and
development1,673,3382,620,5544,108,0965,196,682
General and
administrative3,528,5752,208,0596,746,0664,601,179
Operating loss(5,498,204)(4,828,613)(11,269,613)(9,797,861)
Interest income9,02113,93422,40534,465
Other income4,9965,0229,99611,670
----------------------------------------------
Net loss:$(5,484,187) $(4,809,657) $(11,237,212) $ (9,751,726)
----------------------------------------------
Basic and diluted net
loss per common share $(0.18) $(0.19) $(0.37) $(0.39)
==============================================
Basic and diluted
weighted average
number of common
shares outstanding30,332,21725,262,53830,323,06125,262,538
==============================================
MELA SCIENCES, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(unaudited)
Six Months Ended June 30,
-----------------------------
20122011
---------------------------
Cash flows from operating activities:
Net loss$(11,237,212) $(9,751,726)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization330,395283,785
Noncash compensation774,493734,222
Write off of unamortized financing costs62,391-
Changes in operating assets and
liabilities:
Increase in accounts receivable(68,360)-
Increase in inventory(383,181)-
Decrease (increase) in prepaid
expenses and other current assets306,814(410,357)
Increase (decrease) in accounts
payable and accrued expenses888,813(419,525)
Increase in deferred rent2,77816,956
Increase in other assets(6,751)-
Increase in deferred revenue87,974-
Increase (decrease) in other current
liabilities12,277(647)
---------------------------
Net cash used in operating
activities(9,229,569)(9,547,292)
---------------------------
Cash flows from investing activities:
Purchases of property and equipment(1,390,572)(30,811)
---------------------------
Net cash used in investing
activities(1,390,572)(30,811)
---------------------------
Cash flows from financing activities:
Proceeds from exercise of stock options33,310-
Expenses related to Public Offerings(198,942)-
---------------------------
Net cash used in financing
activities(165,632)-
---------------------------
Net decrease in cash and cash equivalents(10,785,773)(9,578,103)
Cash and cash equivalents at beginning of
period27,996,87130,520,812
---------------------------
Cash and cash equivalents at end of period$17,211,098$20,942,709
---------------------------
Supplemental disclosure of cash flow
information:
Non-cash investing activity:
Re-classification of MelaFind(R) components
from other assets to property and equipment $522,014$-
For further information contact:
For Investors
Lynn Pieper
Westwicke Partners
415-202-5678
For Media
Melissa Hurley
Post+Beam
646-442-2773 |
