MELA Sciences, Inc. (NASDAQ:MELA), (the “Company”), developer of
MelaFind®, an FDA approved optical diagnostic device that assists
dermatologists in the diagnosis of melanoma, today announced
financial results for the fourth quarter and year ended December
31, 2013.
Conference Call
The Company will host a conference call at 4:30pm ET to review
results. Please dial 877-303-9205 (domestic) or 760-536-5226
(international). A live webcast will be available at:
www.melasciences.com. If you are unable to participate during the
live call and webcast, a replay will be archived and available for
approximately 90 days after call.
Fourth Quarter and Full Year 2013 Financial Results
Net Revenues for the three months ended December 31, 2013 were
$140,000 compared to $122,000 for the same period last year, an
increase of 14.75%. Cost of revenue for the fourth quarter was
$914,000 down 5.87% from $971,000 in the prior year. Total
operating expenses for the fourth quarter were $3.6 million down
30.58% from last year, which was due to management’s cost reduction
and cash conservation policy put in place mid-year.
The Company’s net loss for the three months ended December 31,
2013 was $4.6 million, or $0.09 per diluted share, compared to a
net loss of $6.1 million, or $0.19 per diluted share, for the same
period in 2012.
Net Revenues for the twelve months ended December 31, 2013 were
$536,000 compared to $278,000 reported for the same period in 2012,
an increase of 92.81%. Cost of revenue for the full year was $4.3
million compared to $2.0 million for 2012 and primarily relates to
increased depreciation expense for units placed during the year.
Total operating expenses for 2013 were $20.3 million down 3.02%
from last year and included an impairment charge taken in the third
quarter of approximately $1 million related to our MelaFind®
systems placed in the field.
The net loss for 2013 was $25.9 million or $0.60 per share
compared to $22.7 million or $0.74 per share in 2012. The net loss
for 2013 includes the $1 million non-cash impairment charge
mentioned above, a write-off of unamortized loan costs of
approximately $1 million relating to the pay-off of long term debt,
increased interest expense of $0.6 million also attributed to the
long term debt and a non-cash charge of $0.3 million primarily
related to warrants issued in the October 2013 financing that must
be accounted for as a liability.
Fourth Quarter and Full Year 2013 Highlights
On October 31, 2013 the Company closed on a $6 million
registered direct offering, which resulted in net proceeds to the
Company of approximately $5.5 million. As part of the offering the
Company sold just over 4.2 million shares of common stock and
prefunded warrants to purchase up to 4.3 million shares of common
stock. The Company also issued additional warrants to purchase up
to 6.9 million shares of common stock, which could result in
proceeds of $5.8 million, if exercised.
In November, Rose Crane was appointed President and CEO of the
Company bringing over 30 years of healthcare industry experience in
fields such as pharmaceuticals, medical devices and healthcare
services. As President and CEO of Epocrates, a healthcare
technology firm, she directed the efforts to take the company
public.
In October, Dr. Darrell Rigel, Clinical Professor of Dermatology
at New York University, Langone Medical Center was appointed Chief
Medical Advisor to the Board. Dr. Rigel also serves as a Regional
Chair of the Massachusetts Institute of Technology Education
Council.
In the fourth quarter, MELA Sciences participated in various
clinical conferences and meetings including the following:
- MelaFind® was showcased at the American
Society of Dermatologic Surgery Annual Meeting, the meeting was
held over four days and provided attendees the opportunity to stay
current on innovative devices, news and technology;
- presented four Poster Presentations at
the 32nd Annual Fall Clinical Dermatology Conference in Las Vegas
and held its first Clinical Advisory meeting, which announced the
launch of a new user study, called the MelaFind® Experience
Trial (MET–1);
- participated in the Washington D.C.
Dermatological Society’s Fall Clinical Conference, a hands-on
symposium involving live patient case studies and pathology
analysis; and
- in conjunction with the Mount Sinai
Winter Dermatology Symposium, hosted its second Clinical Advisory
Meeting chaired by Dr. Gary Goldenberg, Medical Director of Mount
Sinai’s Dermatology Faculty Practice.
“Having joined MELA Sciences just before the end of the year, I
can only say thank you to everyone from management to staff for
their diligence and hard work throughout 2013. The market proved to
be a difficult one and ultimately the Company realized that a
refocused strategy was in order. So I am happy to say we have
initiated a new business plan and a new business model that will
serve not only MELA but dermatologists and most importantly the
patients at high risk for melanoma,” said Rose Crane, President and
CEO of MELA Sciences.
The new business plan refocuses the Company’s go-to-market
strategy on medical dermatologists who treat high-risk patients and
on Key Opinion Leaders at leading hospitals and teaching
institutions in the United States as they lead the charge on
melanoma.
The new business model allows dermatologists to purchase the
MelaFind® device rather than rent it. This is typically how
business is conducted for medical devices.
The Company is also working diligently on securing insurance
reimbursement codes for both doctors and insurance companies.
Since the end of 2013, the Company has also taken important
steps in raising awareness of, the Company and its product
MelaFind®, and strengthening its balance sheet. Senior management
presented at a small-cap investor conference in New York and was
well received. MelaFind® has been introduced to several major
institutions in the United States gaining placement in four of the
leading melanoma centers.
In February, the Company completed a private placement offering
with two major healthcare institutional investors and its directors
for net proceeds of approximately $11.54 million prior to
approximately $2.5 million in penalties that have applied and up to
an additional $1.4 million in penalties that may apply. As part of
the offering the Company sold shares of its non-redeemable
preferred stock, which is convertible into approximately 14.6
million shares of its common stock and warrants to purchase up to
13.3 million shares of common stock which, if exercised, could
result in proceeds to the Company of up to $9.8 million. In
addition, the Company sold approximately 200,000 shares of its
common stock to its directors.
Please follow us:Twitter: @MELASciencesIR or
@MelaFindFacebook: www.facebook.com/MelaFindStockTwits:
@MELASciencesIR
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
flagship product is MelaFind®, an FDA, PMA and CE Mark approved,
non-invasive diagnostic tool to assist dermatologists in melanoma
evaluation and diagnosis. MelaFind® uses a variety of visible to
near-infrared light waves to analyze atypical pigmented skin
lesions 2.5mm below the skin surface. It provides images and data
on the relative disorganization of a lesion's structure that
provides substantial additional perspective to assist 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.
MELA SCIENCES, INC. BALANCE
SHEETS As of December 31, 2013 and 2012 (in
thousands, except for share and per share data)
2013 2012 ASSETS Current Assets: Cash
and cash equivalents $ 3,783 $ 7,862 Accounts receivable, net 57
180 Inventory, net 5,631 676 Prepaid expenses and other current
assets 880 965
Total Current
Assets 10,351 9,683 Property and equipment, net 3,691 7,350
Patents and trademarks, net 42 47 Deferred financing costs - 106
Other assets 48 84
Total Assets
$ 14,132 $ 17,270
LIABILITIES AND
STOCKHOLDERS' EQUITY Current Liabilities:
Accounts payable $ 1,479 $ 1,850 Accrued expenses 844 956 Deferred
placement revenue 244 172 Warrant liability 3,017 - Other current
liabilities 68 41
Total Current
Liabilities 5,652 3,019
Long Term Liabilities: Deferred placement revenue 64 132
Deferred rent 120 144
Total Long
Term Liabilities 184 276
Total Liabilities 5,836 3,295
COMMITMENTS AND CONTINGENCIES
Stockholders'
Equity Preferred stock - $.10 par value; authorized 10,000,000
shares: issued and outstanding: none Common stock - $.001 par
value; authorized 95,000,000 shares:
Issued and outstanding 47,501,596 and
32,204,720 shares at December 31, 2013 and 2012, respectively.
48 32 Additional paid-in capital 176,396 156,143 Accumulated
deficit (168,148 ) (142,200 )
Stockholders'
Equity 8,296 13,975
Total
Liabilities and Stockholders' Equity $ 14,132 $ 17,270
MELA SCIENCES, INC. STATEMENTS OF
OPERATIONS (in thousands, except for share and per share
data) Three months
ended December 31 Twelve months ended December 31
2013 2012 2013 2012 Net revenues 140
122 536 278 Cost of revenue 914 971
4,341 2,042 Gross profit (774 ) (849 )
(3,805 ) (1,764 ) Operating expenses: Research and
development 540 1,285 3,782 6,792 Selling, general and
administrative 3,096 3,953 15,536 14,169 Impairment of long-lived
assets - - 1,011 -
Total operating expenses 3,636 5,238
20,329 20,961 Operating
loss (4,410 ) (6,087 ) (24,134 ) (22,725 ) Other income
(expenses): Interest income 1 4 8 32 Interest expense (1 ) - (564 )
- Change in fair value of warrant liability (206 ) - (296 ) - Loss
on early extinguishment of debt - - (983 ) - Other income, net
6 5 21 20
(200 ) 9 (1,814 ) 52
Net loss $ (4,610 ) $ (6,078 ) $
(25,948 ) $ (22,673 ) Basic and diluted
net loss per common share $ (0.09 ) $ (0.19 ) $ (0.60 ) $ (0.74 )
Basic and diluted weighted average number
of common shares outstanding
46,058,796 31,727,391 42,894,500
30,762,610
MediaMELA Sciences, Inc.Diana Garcia
Redruello212-518-4226dgarcia@melasciences.comorInvestorsCatalyst
GlobalToni Trigiani, David
Collins212-924-9800mela@catalyst-ir.com
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