EMERYVILLE, Calif.--(BUSINESS WIRE)--NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a biopharmaceutical company commercializing and developing topical non-antibiotic antimicrobial products for the global eye care market, today reported financial results for the three months ended March 31, 2015, and provided a business update.
First Quarter 2015 and Recent Operational and Financial Highlights
- Grew sales of Avenova™ by 112% to $465,000 in the first quarter of 2015 over the fourth quarter of 2014 demonstrating continued momentum from the Avenova commercial product launch.
- Increased the size of NovaBay’s direct sales force promoting Avenova in February 2015 from 14 to 35 medical sales representatives committed to major markets across the U.S.
- Signed nationwide distribution agreements for Avenova with AmerisourceBergen Corporation and Cardinal Health. Avenova is now available through 90% of the 67,000 retail pharmacies across the U.S.
- Announced partner China Pioneer Pharma’s launch of NeutroPhase® Skin and Wound Cleanser in China beginning in March 2015. NovaBay is currently shipping an order for 200,000 units of its NeutroPhase product to its partner China Pioneer Pharma to support the commercial launch in China.
- NovaBay’s NeutroPhase introduced into Taiwan market in February 2015 by China Pioneer Pharma following receipt of regulatory clearance from Taiwan’s Food and Drug Administration in 2014.
- Announced the signing of exclusive distribution agreements with Alpha Pharma LLC to market NeutroPhase in the Ukraine; and Sarmedic Ltd to market Avenova in Israel.
- Announced a securities purchase agreement for the sale of common stock and warrants in a private placement for net proceeds of approximately $4.5 million in March 2015.
- Announced the appointments of Mark M. Sieczkarek as Chairman of the Board and LI Xinzhou (Paul Li) as a Director, effective April 10, 2015. NovaBay founder Dr. Ron Najafi remains on the Board and continues to serve as NovaBay’s President and Chief Executive Officer.
“We are delighted with the initial market acceptance of our innovative daily-use prescription eye care product Avenova,” said Ron Najafi, Ph.D., President and CEO of NovaBay. “For the second consecutive quarter, sales of Avenova more than doubled from the prior quarter. The commercial success of Avenova is at the core of our business strategy to increase near-term revenue and I’m pleased to report that we are seeing strong growth continuing into the second quarter.
“We conducted extensive research to determine the markets with high-prescribing ophthalmologists and optometrists and used this information to position our medical representatives in those markets,” he added. “We expect that our medical representatives will become increasingly productive in the coming months and are supporting their efforts through a comprehensive marketing program. This includes advertising placements in major trade publications featuring reports from key opinion leaders, as well as presentations and exhibitions at numerous industry conferences and vision expos throughout the U.S.
“It is also gratifying that numerous patients who have suffered for years from eyelid inflammation, itching, encrustation, and other annoying symptoms of blepharitis are reporting relief after using Avenova for as little as two weeks,” said Dr. Najafi. “We also are seeing ophthalmologists and optometrists beginning to adopt Avenova into their practices.”
NovaBay management will discuss its financial results for the first quarter of 2015 and provide a business update during its Investor and Analyst Day Event, “Avenova: Going Beyond Antibiotics,” being held in New York City on May 19, 2015. Avenova: Going Beyond Antibiotics will feature key opinion leaders in ophthalmology and optometry discussing the use and benefits of Avenova for the management of chronic eyelid conditions. A live webcast of the event will be available on the Company’s website at www.novabay.com.
First Quarter 2015 Financial Results
In the quarter ended March 31, 2015, NovaBay reported product revenue of $492,000, which included sales of Avenova and NeutroPhase, compared with $188,000 in the three months ended March 31, 2014, and gross profit of $344,000 compared with $58,000 in the three months ended March 31, 2014. The increases in product revenue and gross profit in 2015 are due to commercialization of our Avenova product started at the end of 2014. License, collaboration, distribution and other revenue for the first quarter of 2015 was $46,000.
Net loss for the first quarter of 2015 was $4.6 million, or $0.09 per share, compared with a net loss of $3.6 million, or $0.08 per share, for the first quarter of 2014. The higher net loss in the 2015 quarter was due to spending on sales and marketing activities for Avenova, offset partially by lower spending on research and development. Research & development expenses were $1.6 million and sales, general and administrative expenses were $3.4 million for the first quarter of 2015.
Cash, cash equivalents and short-term investments were $5.6 million as of March 31, 2015, and included net proceeds of $4.5 million from an equity financing completed in March 2015.
About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics®
NovaBay Pharmaceuticals 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, cleared by the US FDA as 510(k) medical device; the NEUTROX™ Family of Products includes AVENOVA™ for the eye care market and NEUTROPHASE® for wound care, and CELLERX™ for the cosmetic surgery and aesthetic dermatology market; and its AGANOCIDE® compounds, led by AURICLOSENE™ which is in development as a new drug in urology and dermatology. NovaBay is partnered in the U.S. and around the globe with: PBE, Inc. (USA), IHT, Inc. (USA), Galderma (France), Virbac (France), China Pioneer Pharma (China and Southeast Asia), Shin Poong Pharmaceuticals (South Korea), Biopharm (North Africa and Middle East), Sarmedic Ltd (Israel) and Alpha Pharma LLC (Ukraine).
Forward-Looking Statements
This release contains forward-looking statements, which are based upon management's current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding the anticipated market acceptance of our products, future sales of our products, and the company’s expected future financial results. Forward-looking 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 the company's ability to obtain additional financing as necessary. 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. | ||||||||
| CONSOLIDATED BALANCE SHEETS | ||||||||
| March 31, | December 31, | |||||||
| 2015 | 2014 | |||||||
|
(in thousands, except par value) |
(unaudited) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 5,598 | $ | 5,429 | ||||
| Accounts receivable | 283 | 273 | ||||||
| Inventory | 492 | 521 | ||||||
| Prepaid expenses and other current assets | 1,223 | 729 | ||||||
| Total current assets | 7,596 | 6,952 | ||||||
| Property and equipment, net | 408 | 436 | ||||||
| Other assets | 151 | 149 | ||||||
| TOTAL ASSETS | $ | 8,155 | $ | 7,537 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Liabilities: | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,178 | $ | 1,865 | ||||
| Accrued liabilities | 1,095 | 1,055 | ||||||
| Deferred revenue | 425 | 425 | ||||||
| Total current liabilities | 3,698 | 3,345 | ||||||
| Deferred revenues - non-current | 1,993 | 2,000 | ||||||
| Deferred rent | 176 | 171 | ||||||
| Warrant liability | 139 | 173 | ||||||
| Total liabilities | 6,006 | 5,689 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.01 par value; 5,000 shares authorized; none outstanding at March 31, 2015 and December 31, 2014 | — | — | ||||||
| Common stock, $0.01 par value; 120,000 shares authorized at March 31, 2015 and December 31, 2014; 61,113 and 51,650 issued and outstanding at March 31, 2015 and December 31, 2014, respectively | 611 | 516 | ||||||
| Additional paid-in capital | 77,725 | 72,879 | ||||||
| Accumulated deficit during development stage | (76,187 | ) | (71,547 | ) | ||||
| Total stockholders' equity | 2,149 | 1,848 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 8,155 | $ | 7,537 | ||||
| NOVABAY PHARMACEUTICALS, INC. | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
| (unaudited) | ||||||||
|
|
Three Months Ended |
|||||||
|
|
March 31, |
|||||||
|
(in thousands, except per share data) |
2015 | 2014 | ||||||
| Sales: | ||||||||
| Product revenue | $ | 492 | $ | 188 | ||||
| Cost of goods sold | 148 | 130 | ||||||
| Gross profit | 344 | 58 | ||||||
| Other revenue: | ||||||||
| License, collaboration and distribution revenue | 6 | 38 | ||||||
| Other revenues | 40 | 62 | ||||||
| Total other revenue | 46 | 100 | ||||||
| Operating expenses: | ||||||||
| Research and development | 1,641 | 2,548 | ||||||
| Sales, general and administrative | 3,410 | 1,708 | ||||||
| Total operating expenses | 5,051 | 4,236 | ||||||
| Operating loss | (4,661 | ) | (4,078 | ) | ||||
| Non-cash gain on changes in fair value of warrants | 34 | 520 | ||||||
| Other income (expense), net | (11 | ) | (7 | ) | ||||
| Loss before provision for income taxes | (4,638 | ) | (3,565 | ) | ||||
| Provision for income taxes | (2 | ) | — | |||||
| Net loss | (4,640 | ) | (3,565 | ) | ||||
|
Change in unrealized gains on available-for-sale securities |
— | 2 | ||||||
| Comprehensive loss | $ | (4,640 | ) | $ | (3,563 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted | $ | (0.09 | ) | $ | (0.08 | ) | ||
| Shares used in per share calculations: | ||||||||
| Basic and diluted | 54,371 | 45,338 | ||||||