- 3Q16 total sales nearly tripled from
3Q15 to record $3.4 million
- Affirms outlook to reach positive
adjusted cash flow from operations in December 2016
- Regained compliance with NYSE
listing requirements
Conference call begins today at 4:30 p.m.
Eastern time
NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a
biopharmaceutical company focusing on commercializing its
prescription Avenova® lid and lash hygiene product for the domestic
eye care market, reports financial results for the three and nine
months ended September 30, 2016, and provides a business
update.
“This is an exceptional time at NovaBay as we achieved yet
another quarter of record Avenova sales, growing 176% over the
third quarter of 2015 and up 20% from the second quarter of 2016,
and putting us on an estimated annualized run rate of $12 million,”
said Mark M. Sieczkarek, NovaBay’s President and CEO. “Importantly,
68% of Avenova sales came from the higher-margin prescription
ophthalmology channel. This is a 25% increase in prescription sales
from the second quarter as we continue to execute on our channel
strategy.
“This positive change in sales channel mix contributed to the
gross margin on Avenova product sales expanding to 88%. We reduced
our adjusted use of cash from operations from $5.8 million for the
fourth quarter of last year when we implemented a restructuring to
$1.2 million for the third quarter of 2016,” he added. “All in all,
we believe we are well on our way to achieving our goal of positive
adjusted cash flow from operations in December 2016.
“Importantly, during the quarter and with the support of our
investors we implemented a warrant exercise that boosted our cash
position to $9.4 million, the highest level in three years. The
additional funds were essential to keeping our listing on the NYSE
MKT exchange, which allows us to maintain greater visibility with
the investment community. We expect to use these additional funds
to support the continued growth of our commercial activities and
drive Avenova sales in this largely untapped market of
approximately 41 million Americans.”
NovaBay defines adjusted cash flow from operations as GAAP cash
flow from operations less changes in operating assets and
liabilities.
Key Third Quarter Avenova Metrics
- Avenova sales of $3.1 million increased
nearly three-fold (176%) year-over-year and 20% over 2Q16;
- Prescription sales into the pharmacy
channel of $2.1 million were more than six-fold (550%) higher
year-over-year and up 25% over 2Q16;
- New prescribers increased by more than
1,100;
- Total number of medical professionals
who have prescribed Avenova increased by 17%, to more than
7,700.
Third Quarter 2016 Financial Results
Net sales for the third quarter of 2016 of $3.4 million, were
nearly three times the $1.2 million reported for the third quarter
of 2015 and up 29% from $2.7 million for the second quarter of
2016. Product revenue, which includes sales of Avenova and
NeutroPhase®, was $3.3 million, up 187% from $1.1 million for the
third quarter of 2015 and up 23% from $2.7 million for the second
quarter of 2016. Total gross profit margin was 84% for the third
quarter of 2016, compared with 78% for the prior-year period and
82% for the preceding quarter, with the increase mainly due to
higher sales of Avenova and the recognition of revenue upon the
termination of a collaborative agreement. The gross profit margin
on Avenova sales increased to 88%, up from 85% in the preceding
quarter.
Operating loss for the third quarter of 2016 was $2.0 million,
representing improvements of 62% from $5.3 million for the third
quarter of 2015 and 9% from $2.2 million for the second quarter of
2016. R&D expenses were $4 thousand for the third quarter of
2016 versus $1.6 million for the third quarter of 2015 and $278
thousand for the second quarter of 2016. The decreases are
primarily due to lower spending on clinical trials that were
completed, the Company’s focus of resources on Avenova
commercialization and the exchange of laboratory equipment for
R&D services in the third quarter of 2016 that were valued in
excess of the net book value of the equipment. G&A expenses for
the third quarter of 2016 of $2.2 million compared with $1.7
million for the prior-year period and $1.3 million for the second
quarter of 2016. The increase is primarily due to modification of
the exercise price for warrants issued in May 2015, higher
stock-based compensation expense and costs associated with
subleasing the Company’s previous headquarters location. Sales and
marketing expenses for the third quarter of 2016 decreased 12% to
$2.7 million from $3.0 million for the third quarter of 2015 and
decreased 7% from $2.9 million for the second quarter of 2016,
primarily due to reduced sales force expenses.
Non-cash loss on the change of fair value of warrant liability
for the three months ended September 30, 2016 was $1.7 million,
compared with a gain of $139 thousand for the three months ended
September 30, 2015. The non-cash loss on changes in fair value of
warrant liability was primarily due to the increase in the price of
the Company’s common stock during the quarter.
The net loss for the third quarter of 2016 was $3.7 million, or
$0.34 per share, compared with a net loss for the third quarter of
2015 of $5.2 million, or $1.77 per share. The net loss for the
third quarter of 2016 increased by $1 million or 39% from the
second quarter of 2016, primarily due to a non-cash charge related
to a revaluation of warrant liabilities.
Nine-Month 2016 Financial Results
Net sales for the nine months ended September 30, 2016 were $7.8
million, up 185% from $2.7 million for the nine months ended
September 30, 2015, with the increase primarily attributable to
significantly higher sales of Avenova. Product revenue for the
first nine months of 2016 increased 196% to $7.6 million. Gross
profit margin was 79% for the first nine months of 2016, compared
with 76% for the first nine months of 2015. Gross profit margin on
Avenova sales was 85% for the nine months ended September 30,
2016.
Operating loss for the first nine months of 2016 narrowed by 41%
to $8.8 million from $14.9 million for the comparable period in
2015. R&D expenses for the first nine months of 2016 declined
73% to $1.2 million from the prior-year period, and G&A
expenses were relatively unchanged. Sales and marketing expenses
for the nine months ended September 30, 2016 were $8.7 million, an
increase of 19% from the prior-year period.
Non-cash loss on the change of fair value of warrant liability
for the first nine months of 2016 was $2.5 million, compared with a
gain of $173 thousand for the first nine months of 2015. The
non-cash loss on changes in fair value of warrant liability was
primarily due to the increase in the price of the Company’s common
stock since December 31, 2015.
The net loss for the nine months ended September 30, 2016 was
$11.5 million, or $1.54 per share, compared with a net loss for the
nine months ended September 30, 2015 of $14.8 million, or $5.68 per
share.
NovaBay reported cash of $9.4 million as of September 30, 2016,
compared with $2.4 million as of December 31, 2015. On May 5, 2016,
the Company closed the first tranche of a financing for gross
proceeds of $7.8 million and on July 31, 2016, the Company closed
the second and final tranche for gross proceeds of $4.0 million.
During the third quarter of 2016, warrants were exercised for net
proceeds to the Company for approximately $6.6 million.
The Company used approximately $3.8 million in cash to fund
operations during the third quarter of 2016, compared with $4.1
million used during the third quarter of 2015 and $2.7 million used
during the second quarter of 2016. The decrease in cash to fund
operations in the third quarter of 2016 from the prior year was
primarily due to higher gross profit from Avenova sales and lower
operating expenses achieved through companywide cost-reduction
programs.
Conference Call
NovaBay management will host an investment community conference
call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific
time) to discuss the Company’s financial and operational results
and to answer questions. Shareholders and other interested parties
may participate in the conference call by dialing 800-608-8202 from
within the U.S. or 702-495-1913 from outside the U.S., with the
conference identification number 936110901.
A live webcast of the call will be available at
http://novabay.com/investors/events and will be archived for 90
days.
A replay of the call will be available beginning two hours after
call completion through 11:59 p.m. Eastern time December 10, by
dialing 855-859-2056 from within the U.S. or 404-537-3406 from
outside the U.S. and entering the conference identification number
936110901.
About NovaBay Pharmaceuticals, Inc.: Going Beyond
Antibiotics®
NovaBay Pharmaceuticals is a biopharmaceutical company focusing
on the commercialization of prescription Avenova® lid and lash
hygiene for the eye care market. Avenova is formulated with
Neutrox™, which is cleared by the U.S. Food and Drug Administration
(FDA) as a 510(k) medical device. Neutrox is NovaBay’s pure
hypochlorous acid. Laboratory tests show that pure hypochlorous
acid has potent antimicrobial activity in solution yet is non-toxic
to mammalian cells and neutralizes bacterial toxins. Data from a
multicenter clinical study show that Avenova reduced bacterial
load, the underlying cause of blepharitis, on ocular skin surface
by more than 90%. Avenova is marketed to optometrists and
ophthalmologists throughout the U.S. by NovaBay’s direct medical
salesforce. It is accessible from more than 90% of retail
pharmacies in the U.S. through agreements with McKesson
Corporation, Cardinal Health and AmerisourceBergen.
Forward-Looking Statements
This release contains forward-looking statements that are based
upon management's current expectations, assumptions, estimates,
projections and beliefs. These statements include, but are not
limited to, statements regarding our ability to become cash flow
positive by the end of 2016, future sales of our products, our
current “run rate,” and the Company’s expected future financial
results. Forward-looking statements can be identified with words
like (and variations of): “estimate,” “believe,” and “expect.”
These statements involve known and unknown risks, uncertainties and
other factors that may cause actual results or achievements to be
materially different and adverse from those expressed in or implied
by the forward-looking statements. Factors that might cause or
contribute to such differences include, but are not limited to,
risks and uncertainties relating to difficulties or delays in
manufacturing, distributing, and selling the Company's products,
unexpected adverse side effects or inadequate therapeutic efficacy
of our product, the uncertainty of patent protection for the
Company's intellectual property, and any potential regulatory
violations. Other risks relating to NovaBay’s business,
including risks that could cause results to differ materially from
those projected in the forward-looking statements in this press
release, are detailed in NovaBay's latest Form 10-K and Form 10-Q
filings with the Securities and Exchange Commission, especially
under the heading "Risk Factors." The forward-looking
statements in this release speak only as of this date, and NovaBay
disclaims any intent or obligation to revise or update publicly any
forward-looking statement except as required by law.
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NOVABAY PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS (Unaudited) (In thousands, except per
share data) September 30,
December 31, 2016 2015
ASSETS Current assets: Cash $ 9,430 $ 2,385 Accounts
receivable, net of allowance for doubtful accounts ($14 and $40 at
September 30, 2016 and December 31, 2015, respectively) 2,079 536
Inventory, net of allowance for obsolete inventory and lower cost
of market ($77 and $45 at September 30, 2016 and December 31, 2015,
respectively) 1,084 1,345 Prepaid expenses and other current assets
1,827 261 Total current assets 14,420
4,527 Property and equipment, net 282 395 Other assets 439
155 TOTAL ASSETS $ 15,141 $ 5,077
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Liabilities: Current liabilities: Accounts payable $ 387 $ 2,483
Accrued liabilities 1,880 1,980 Deferred revenue 1,461
170 Total current liabilities 3,728 4,633
Deferred revenues - non-current 1,913 2,248 Deferred rent 248 189
Notes payable, related party - 1,655 Warrant liability 2,336 1,450
Other Liabilities 198 Total liabilities
8,423 10,175 Stockholders' Equity
(deficit): Common stock, $0.01 par value; 240,000,000 shares
authorized 14,865,507 and 3,486,232 shares issued and outstanding
at September 30, 2016 and December 31, 2015, respectively 149 35
Additional paid-in capital 108,592 85,387 Accumulated
deficit (102,023 )
(90,520
)
Total stockholders' equity (deficit) 6,718
(5,098
)
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) $ 15,141
$ 5,077
NOVABAY PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS (Unaudited) (In thousands, except
per share data)
Three Months Ended
Nine Months Ended
September 30,
September 30, 2016 2015
2016 2015 Sales: Product revenue $
3,262 $ 1,136 $ 7,571 $ 2,559 Other revenue 176
64 249
187
Total net sales 3,438 1,200 7,820 2,746 Product cost
of goods sold 566 269 1,656
670 Gross profit 2,872
931 6,164 2,076 Research
and development 4 1,563 1,215 4,503 Sales and marketing 2,663 3,035
8,660 7,260 General and administrative 2,218
1,681 5,131 5,181 Total
operating expenses 4,885 6,279
15,006 16,944 Operating Loss (2,013 ) (5,348 )
(8,842 ) (14,868 ) Non cash (loss) gain on changes in fair
value of warrant liability (1,671 ) 139 (2,480 ) 173 Other expense,
net (52 ) (31 ) (179 ) (64 )
Loss before provision for income taxes (3,736 ) (5,240 ) (11,501 )
(14,759 ) Provision for income tax - (2 )
(2 ) (10 ) Net loss and comprehensive loss $ (3,736 )
$ (5,242 ) $ (11,503 ) $ (14,769 ) Net loss per share
attributable to common stock (basic and diluted) $ (0.34 ) $ (1.77
) $ (1.54 ) $ (5.68 ) Weighted-average shares of common
stock outstanding used in computing net loss per share of common
stock 10,912,616 2,957,477 7,480,985 2,598,052
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version on businesswire.com: http://www.businesswire.com/news/home/20161110006401/en/
NovaBay ContactsFor NovaBay
Avenova purchasing information, please
contact:800-890-0329www.Avenova.comorFrom
the CompanyNovaBay Pharmaceuticals, Inc.Thomas J.
PaulsonChief Financial Officer510-899-8809Contact TomorInvestor ContactLHAJody
Cain310-691-7100Jcain@lhai.com
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