Conference call begins today at 4:30 p.m.
Eastern time
NovaBay® Pharmaceuticals,
Inc. (NYSE American: NBY), a biopharmaceutical company
focusing on commercializing prescription Avenova® for the domestic
eye care market, reports financial results for the three months
ended March 31, 2019 and provides a business update.
“As we discussed when reporting fourth quarter 2018 financial
results, net sales for the first quarter of 2019 were impacted by
significant industry-wide changes in the reimbursement of branded
pharmaceutical products,” said Justin Hall, interim President and
CEO. “Our objective remains to make Avenova affordable to patients
through rebates and coupons. However, the annual reset in
healthcare plan deductibles, the continuing trend toward individual
high-deductible healthcare plans along with the decision by certain
nationwide insurers to end reimbursement coverage for Avenova are
affecting unit sales and gross-to-net pricing more than in past
years.
“We are adapting to this new reimbursement environment with
various strategies to ensure that Avenova is affordable and
accessible to all patients while providing NovaBay with appropriate
economics,” he said. “We have expanded our partner pharmacy program
that serves patients in all 50 states, ensuring product
availability at the best pricing. This program has the added
benefit of contracted pricing for Avenova, therefore improving our
gross-to-net pricing. We are also opening opportunities for more
eye care specialists to access our in-office sales channel in which
they resell Avenova at affordable prices directly to their
patients. We plan in the coming months to further broaden access to
Avenova through an entirely new direct-to-patient sales
channel.
“In March we implemented the strategic shift in our commercial
operations and, as such, expenses for the first quarter reflect our
prior strategy,” he added. “We expect to begin realizing cost
savings from this reduction in force in the second quarter, and to
significantly reduce operating expenses over the remainder of
2019.”
First Quarter Financial Results
Net sales for the first quarter of 2019 were $1.5 million
compared with $2.9 million for the first quarter of 2018, with the
decrease due to lower unit sales and lower gross-to-net pricing of
Avenova. Gross margin on net product revenue was 77% for the first
quarter of 2019 compared with 91% for the prior-year period, with
the decrease due to lower product revenue.
Sales and marketing expenses for the first quarter of 2019 were
$3.5 million compared with $3.4 million for the first quarter of
2018. General and administrative expenses for the first quarters of
2019 and 2018 were unchanged at $1.6 million. Research and
development expenses for the first quarter of 2019 were $85,000
compared with $46,000 for 2018.
Operating loss for the first quarter of 2019 was $4.1 million
compared with an operating loss of $2.4 million for the first
quarter of 2018.
Non-cash loss on the change of fair value of warrant liability
for the first quarter of 2019 was $0.1 million compared with a
non-cash gain of $0.2 million for the first quarter of 2018.
Non-cash loss on the embedded derivative associated with the
convertible note for the first quarter of 2019 was $0.6 million.
The Company did not record a comparable loss or gain for the first
quarter of 2018. The Company is working with its auditors and
outside consultants regarding the valuation of the convertible
note, which may cause a variation in the financials reported in the
Company’s Form 10-Q.
The net loss for the first quarter of 2019 was $4.8 million, or
$0.28 per share, compared with a net loss for the first quarter of
2018 of $2.2 million, or $0.13 per share.
NovaBay reported cash and cash equivalents of $2.9 million as of
March 31, 2019, compared with $3.2 million as of December 31,
2018.
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 8495204.
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 ends through 8:59 p.m. Eastern time May 17, 2019 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
8495204.
Receipt of Audit Opinion with Going Concern
Qualification
As disclosed in its Annual Report on Form 10-K for the fiscal
year ended December 31, 2018, which was filed with the Securities
and Exchange Commission on March 29, 2019 and amended on April 12,
2019, the Company’s audited financial statements contained a going
concern explanatory paragraph in the audit opinion from its
independent registered public accounting firm. This announcement
does not represent any change or amendment to the Company’s
financial statements or to its Annual Report on Form 10-K for the
fiscal year ended December 31, 2018, as amended.
About Avenova®
Avenova is an eye care product formulated with our proprietary,
stable and pure form of hypochlorous acid. It has proven in
laboratory testing to have broad antimicrobial properties as a
preservative in solution as it removes foreign material including
microorganisms and debris from the skin on the eyelids and lashes
without burning or stinging. Avenova is marketed to optometrists
and ophthalmologists throughout the U.S. by NovaBay’s direct
salesforce. It is accessible from more than 90% of retail
pharmacies in the U.S. through agreements with McKesson
Corporation, Cardinal Health and AmerisourceBergen.
About NovaBay Pharmaceuticals, Inc.: Going Beyond
Antibiotics®
NovaBay Pharmaceuticals, Inc. is a biopharmaceutical company
focusing on commercializing and developing its non-antibiotic
anti-infective products to address the unmet therapeutic needs of
the global, topical anti-infective market with its two distinct
product categories: the NEUTROX® family of products and the
AGANOCIDE® compounds. The Neutrox family of products includes
AVENOVA® for the eye care market, NEUTROPHASE® for wound care
market, and CELLERX® for the aesthetic dermatology market. The
Aganocide compounds, still under development, have target
applications in the dermatology and urology markets.
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 business strategies and future
focus, our estimated future revenue, and generally the Company’s
expected future financial results. 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 the size of the potential market for our
products, improving sales rep productivity and product
distribution, obtaining adequate insurance reimbursement, and any
potential regulatory problems. 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-Q/K
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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Avenova Purchasing
InformationFor NovaBay Avenova purchasing
information:Please call 800-890-0329 or email sales@avenova.com.www.Avenova.com
NOVABAY PHARMACEUTICALS, INC. CONSOLIDATED BALANCE
SHEETS (in thousands, except par value amounts)
March 31, December 31,
2019 2018 (Unaudited)
ASSETS Current assets:
Cash and cash equivalents $ 2,932 $ 3,183 Accounts receivable, net
of allowance for doubtful accounts ($24 and $10 at March 31, 2019
and December 31, 2018, respectively) 2,430 3,385 Inventory, net of
allowance for excess and obsolete inventory and lower of cost or
estimated net realizable value adjustments ($110 and $104 at March
31, 2019 and December 31, 2018, respectively) 302 280 Prepaid
expenses and other current assets 1,451 1,760
Total current assets 7,115 8,608 Operating lease
right-of-use assets 1,870 - Property and equipment, net 193 201
Other assets 542 552 TOTAL ASSETS $
9,720 $ 9,361
LIABILITIES AND STOCKHOLDERS'
EQUITY Liabilities: Current liabilities: Accounts payable $ 462
$ 551 Accrued liabilities 2,860 3,255 Deferred revenue - 41
Operating lease liabilities 1,073 - Notes payable, related party
1,019 - Total current liabilities 5,414
3,847 Operating lease liabilities-non-current 1,143 - Deferred rent
- 184 Warrant liability 179 178 Convertible note 33 -
Embedded derivative liability associated
with the convertible note
2,410 - Other liabilities 201 198 Total
liabilities 9,380 4,407
Stockholders' equity:
Preferred stock: 5,000 shares authorized; none outstanding at March
31, 2019 and December 31, 2018 — — Common stock, $0.01 par value;
50,000 shares authorized; 17,095 and 17,089 shares issued and
outstanding at March 31, 2019 and December 31, 2018, respectively
171 171 Additional paid-in capital 120,300 119,764 Accumulated
deficit (120,131 ) (114,981 ) Total stockholders'
equity 340 4,954 TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY $ 9,720 $ 9,361
NOVABAY PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) (in
thousands except per share data)
Three Months Ended March 31,
2019 2018 Sales: Product revenue, net $
1,450 $ 2,934 Other revenue 41 13 Total sales, net
1,491 2,947 Product cost of goods sold 341 251
Gross profit 1,150 2,696 Research and
development 85 46 Sales and marketing 3,531 3,396 General and
administrative 1,605 1,622 Total operating expenses
5,221 5,064 Operating loss (4,071 ) (2,368 )
Non cash (loss) gain on changes in fair value of warrant liability
(57 ) 214 Non cash loss on embedded derivative associated with the
convertible note (592 ) - Other (expense) income, net (73 ) 4
Loss before provision for income taxes (4,793 )
(2,150 ) Provision for income tax (1 ) - Net loss and
comprehensive loss $ (4,794 ) $ (2,150 ) Net loss per share
attributable to common stockholders, basic $ (0.28 ) $ (0.13 ) Net
loss per share attributable to common stockholders, diluted $ (0.28
) $ (0.14 ) Weighted-average shares of common stock outstanding
used in computing net loss per share of common stock Basic 17,093
16,406 Diluted 17,093 16,670
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version on businesswire.com: https://www.businesswire.com/news/home/20190509005885/en/
NovaBay ContactJustin
HallInterim President and Chief Executive
Officer510-899-8800jhall@novabay.com
Investor ContactLHA Investor
RelationsJody Cain310-691-7100jcain@lhai.com
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