NBY NovaBay Pharmaceuticals Inc.

1.13
+0.01  (+1%)
Previous Close 1.12
Open 1.1
52 Week Low 0.24
52 Week High 1.94
Market Cap $47,214,320
Shares 41,782,584
Float 31,265,096
Enterprise Value $39,098,404
Volume 24,516,931
Av. Daily Volume 5,486,402
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
Auriclosene (NVC-422)
Impetigo skin infection study
Phase 2a
Phase 2a
Failed to meet endpoint Nov 2013. Plans to reinitiate trial in 2014
Auriclosene (NVC-422)
Viral conjunctivitis
Phase 2b
Phase 2b
Data released August 2014. Endpoints not met

Latest News

  1. NovaBay Pharmaceuticals (NYSE:NBY) issued the following Letter to Stockholders:

    To My Fellow Stockholders:

    NovaBay Pharmaceuticals enters 2021 focused on growing sales of our high-quality, differentiated consumer products: Avenova®, the premier antimicrobial lid and lash spray, and CelleRx® Clinical Reset, a breakthrough product that marked our entry into a new beauty category late last year. I'm excited to announce that we will soon expand consumer access to both products to brick-and-mortar retail stores. Avenova will be available at CVS stores, one of the nation's largest retail chains, and CelleRx Clinical Reset will be available to consumers in the U.S. and China through select luxury retailers.

    Among our corporate priorities for the…

    NovaBay Pharmaceuticals (NYSE:NBY) issued the following Letter to Stockholders:

    To My Fellow Stockholders:

    NovaBay Pharmaceuticals enters 2021 focused on growing sales of our high-quality, differentiated consumer products: Avenova®, the premier antimicrobial lid and lash spray, and CelleRx® Clinical Reset, a breakthrough product that marked our entry into a new beauty category late last year. I'm excited to announce that we will soon expand consumer access to both products to brick-and-mortar retail stores. Avenova will be available at CVS stores, one of the nation's largest retail chains, and CelleRx Clinical Reset will be available to consumers in the U.S. and China through select luxury retailers.

    Among our corporate priorities for the year, we are also actively seeking new products and line extensions in the large ophthalmic and skincare markets. Our experienced commercial organization, improved balance sheet and established industry relationships give us confidence that now is the opportune time to leverage these assets to generate new sources of revenue to increase stockholder value.

    Building on Avenova's Leadership Position

    By the end of February, we expect Avenova to be on the shelves of up to 3,000 CVS Pharmacy stores across the U.S. and available through CVS.com, a leading online drugstore. With this first-time brick-and-mortar presence, consumers have the option of buying Avenova without a prescription at their local CVS store, in addition to online through Amazon.com, Walmart.com, Avenova.com and CVS.com. We also continue to promote prescription sales through our physician dispensed and pharmacy channels.

    Since introducing Avenova for the treatment of bacterial dry eye in late 2015, we have continuously expanded our customer base. Our product is unique among competitors because our patented, pure, proprietary hypochlorous acid does not have the impurities found in competing brands and unlike them Avenova is manufactured in the U.S. Avenova is the only commercial hypochlorous acid lid and lash product clinically proven to reduce bacterial load on ocular surfaces, thus addressing the underlying cause of bacterial dry eye. We believe our pure formulation supported by proven clinical data have made Avenova the leading hypochlorous acid-based product because physicians and consumers understand the need for a safe, effective antimicrobial spray. We have reached over 10,000 prescribers and well over 100,000 consumers to date. Importantly, the market holds ample room for growth as chronic dry eye afflicts approximately 30 million Americans, with ocular bacteria accounting for about 85% of those cases.

    We migrated to a direct-to-consumer channel in mid-2019, expanding our previous prescription-only sales model. This decision proved to be especially fortuitous during the COVID-19 pandemic by allowing consumers to order Avenova without a prescription and without leaving their homes. We supported this move through aggressive, cost-effective consumer digital marketing campaigns featuring compelling lifestyle-based messaging. These campaigns have already attracted new users, as evidenced by record Avenova unit sales last year.

    During 2020, we increased Avenova's geographic availability through a distribution agreement with Designs for Vision for Australia. We were delighted to expand internationally by engaging with this highly reputable brand and look forward to supporting their growth in the Australian market this year.

    Lastly, our previously announced independent laboratory results confirmed that our pure hypochlorous acid kills SARS-CoV-2, the virus that causes COVID-19, on hard surfaces. We submitted this data to the Environmental Protection Agency (EPA) for inclusion of Avenova on its N list of COVID-19 disinfectants. Under that name, the EPA verified our solution's viricidal abilities and included our product on the N list, under the brand names of NovaBay Hard Non-Porous Surface Pro and Avenova Surface Pro Plus. These two products are not meant to compete against traditional cleaning products, but rather are intended for only large-quantity institutional sales where a completely nontoxic cleansing solution is necessary.

    Positioning CelleRx Clinical Reset in the High-End Beauty Market

    We were delighted to launch Clinical Reset late last year under our CelleRx dermatology brand. Clinical Reset aligns with our strategy to cost-effectively expand our product offering by leveraging our own pure hypochlorous acid technology. Importantly, Clinical Reset stands out in a crowded market by bringing a new level of clinical research and rigor to the beauty industry.

    CelleRx Clinical Reset is a gentle and soothing facial spray that disrupts the layer of bacteria that settles and grows on the face. When this barrier is out of balance, acne, rosacea and infection and even "maskne" can set in. As the brand name suggests, Clinical Reset gets the skin back to a healthy baseline to heal itself while also enabling absorption of other skincare products. It can replace or augment a morning cleanse for dry sensitive skin, reduce bacteria after exercising, calm skin following microdermabrasion and other aesthetic facial procedures and combat environmental aggressors. Unlike many harsh products used for the same purpose, it is gentle and is not an antibiotic. Our launch was well-timed, as during the pandemic personal care has gained importance, with skincare representing a significant aspect of that routine.

    In alignment of our brand image, Clinical Reset will soon be available at global luxury retailer Lane Crawford in Hong Kong and China, as well as online for consumers worldwide at LaneCrawford.com. I'm pleased to report that we also expect in the near term to receive Clinical Reset purchase orders from other prominent U.S.-based luxury retailers for both in-store and online sales. I'm proud of our team's ability to quickly execute on the promise to broaden the distribution of Clinical Reset beyond CelleRx.com, and to do so with retailers that reinforce our vision and branding for this product.

    Improved Financial Position to Support Growth

    NovaBay is well-positioned to implement our growth strategy as a result of various initiatives we undertook last year. We added incremental revenue early in the pandemic by capitalizing on our international health supply network to sell personal protection equipment (PPE) while product was in short supply. Our team at NovaBay demonstrated great agility by quickly creating the infrastructure to offer these products with timely order fulfillment. We continue to offer the last of our KN95 protective masks to institutions at bulk pricing. Please contact for purchasing information. We only have a limited supply and would like to help end the pandemic in the first half of 2021 by ensuring everyone has access to clean, disposable, and individually wrapped facial coverings.

    Also, last year we strengthened and simplified our balance sheet. Even with the effects of COVID-19 on our core business, we reduced our cash burn and raised operating capital. We also eliminated all major debt instruments. As a result, we believe our funds are sufficient to support current operations throughout 2021 including our enhanced online marketing and advertising programs for Avenova and the launch of Clinical Reset.

    This is an exciting time at NovaBay with more to come. We have worked hard to advance our core business and better position our Company for a stronger post-pandemic environment. Our priority during 2021 is to focus on growth, both organically and through potential partnerships and acquisitions. We have already achieved a formidable initial step by broadening consumer access to Avenova and Clinical Reset through brick-and-mortar retail stores and increased online availability. In addition, we continue to evaluate opportunities to acquire or license ophthalmic and skincare products, and will pursue select line extensions to enhance revenue. We will continue to be resourceful in quickly capitalizing on opportunities that may come our way.

    In closing, I would like to extend my thanks to our customers, medical professionals, employees and to our shareholders for your support. We look forward to providing updates as the year proceeds.

    Sincerely,

    Justin Hall, Esq.

    Chief Executive Officer and General Counsel

    February 8, 2021

    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.

    Forward-Looking Statements

    Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial progress and future financial performance of NovaBay Pharmaceuticals, Inc. 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 the Company's products and the intended growth of such products, the Company's potential expansion into new product lines through partnerships and acquisitions, and any future revenue that may result from selling these products, as well as 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 or future products, the possibility that the available market for the Company's products or future products will not be as large as expected, the Company's products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to meet the Company's cash needs, 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.

    Socialize and Stay informed on NovaBay's progress

    Like us on Facebook

    Follow us on Twitter

    Connect with NovaBay on LinkedIn

    Visit NovaBay's Website

    Avenova Purchasing Information

    For NovaBay Avenova purchasing information:

    Please call 800-890-0329 or email

    www.Avenova.com

    CelleRx Clinical Reset Purchasing Information

    For NovaBay CelleRx Clinical Reset purchasing information

    Please call 877-CELLERX

    www.CelleRx.com

    View Full Article Hide Full Article
  2. NovaBay's pure hypochlorous formulation safely eliminates 99.9% of viruses and bacteria on nonporous hard surfaces without cytotoxic chemicals

    NovaBay® Pharmaceuticals, Inc. (NYSE American: NBY) announces its proprietary hypochlorous acid solution has received U.S. Environmental Protection Agency (EPA) approval for a kill claim against SARS-CoV-2, the virus that causes COVID-19. This official listing follows the July 2020 announcement that independent, third-party laboratory results demonstrated that NovaBay's proprietary formulation kills SARS-CoV-2 on hard surfaces.

    "The FDA requires that any product containing hypochlorous acid (HOCl) used by patients in healthcare is registered as a medical device and may be marketed as either a prescription…

    NovaBay's pure hypochlorous formulation safely eliminates 99.9% of viruses and bacteria on nonporous hard surfaces without cytotoxic chemicals

    NovaBay® Pharmaceuticals, Inc. (NYSE American: NBY) announces its proprietary hypochlorous acid solution has received U.S. Environmental Protection Agency (EPA) approval for a kill claim against SARS-CoV-2, the virus that causes COVID-19. This official listing follows the July 2020 announcement that independent, third-party laboratory results demonstrated that NovaBay's proprietary formulation kills SARS-CoV-2 on hard surfaces.

    "The FDA requires that any product containing hypochlorous acid (HOCl) used by patients in healthcare is registered as a medical device and may be marketed as either a prescription (Rx) or over-the-counter (OTC) product following its intended use label guidelines. However, it is the EPA that regulates disinfectants on surfaces and requires formal testing of such products to make any disinfectant claims, even if the ingredients are the same as the FDA-registered product," said Justin Hall, NovaBay's CEO. "Obtaining EPA Registration Number 98003-1 for NovaBay Hard Nonporous Surface Pro is a validation that our HOCl solution is effective against the virus and can be used by consumers to safely disinfect commonly used personal items like eyeglasses, facial coverings, and cell phones."

    Hypochlorous acid has been used for more than 100 years by medical professionals for disinfecting medical equipment and dressing wounds. Until recently, all HOCl solutions contained toxic chemicals like sodium hypochlorite, or were very unstable and could not be stored for long periods of time. In 2015, NovaBay revolutionized the HOCl marketplace with a pure and stable formulation, devoid of bleach particles and toxic impurities.

    "The special characteristics of NovaBay's proprietary HOCl, plus state-of-the-art manufacturing in the USA, set it apart from all other hypochlorous acid products," added Mr. Hall. "We are highly pleased that our years of research and development, independent laboratory testing, and our interaction with the EPA have culminated in NovaBay Hard Nonporous Surface Pro's recognition for use in combating the spread of the coronavirus."

    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, CELLERX® for the aesthetic dermatology market and NEUTROPHASE® for the wound care market. The Aganocide compounds, still under development, have target applications in the dermatology and urology markets.

    Forward-Looking Statements

    Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial progress and future financial performance of NovaBay Pharmaceuticals, Inc. 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 the regulatory clearance of any of our products or future products, and any future revenue that may result from selling these products, as well as 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, the possibility that the available market for the Company's products will not be as large as expected, the Company's products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to meet the Company's cash needs, 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.

    Socialize and Stay informed on NovaBay's progress

    Like us on Facebook

    Follow us on Twitter

    Connect with NovaBay on LinkedIn

    Visit NovaBay's Website

    Avenova Purchasing Information

    For NovaBay Avenova purchasing information:

    Please call 800-890-0329 or email

    www.Avenova.com

    View Full Article Hide Full Article
  3. NovaBay® Pharmaceuticals, Inc. (NYSE:NBY), a pharmaceutical company focusing on commercializing Avenova® for the eye care market, announces the signing of an agreement with Paragon Care Group Australia Pty Ltd for the exclusive distribution of Avenova in Australia. Paragon Care Group will begin distributing Avenova directly to consumers under its Designs For Vision brand beginning in early 2021.

    "We are delighted to expand the geographic reach of Avenova with this agreement covering Australia," said Justin Hall, NovaBay CEO. "In Designs for Vision we have secured an ideal partner with a reputation for sourcing the highest quality products and an established market presence from more than 40 years of serving the ophthalmology and optometry…

    NovaBay® Pharmaceuticals, Inc. (NYSE:NBY), a pharmaceutical company focusing on commercializing Avenova® for the eye care market, announces the signing of an agreement with Paragon Care Group Australia Pty Ltd for the exclusive distribution of Avenova in Australia. Paragon Care Group will begin distributing Avenova directly to consumers under its Designs For Vision brand beginning in early 2021.

    "We are delighted to expand the geographic reach of Avenova with this agreement covering Australia," said Justin Hall, NovaBay CEO. "In Designs for Vision we have secured an ideal partner with a reputation for sourcing the highest quality products and an established market presence from more than 40 years of serving the ophthalmology and optometry sectors in Australia."

    "Avenova fits extremely well with our portfolio of eye care products," said Nikolas Apostolou, General Manager of Designs for Vision. "It is the only commercially available pure hypochlorous acid lid and lash spray proven to be effective in eliminating the underlying cause of bacterial dry eye, yet Avenova is soothing, safe and effective for long-term use. We believe these qualities make Avenova the best product to treat the chronic bacterial infections that affect approximately 85% of all dry eye sufferers. We are thrilled to make this product available to Australians with dry eye disease."

    Avenova previously received approval from the Australian Government Department of Health and was provided an Australian Register of Therapeutic Good Certificate for distribution in that country.

    About Paragon Care Group Australia Pty Ltd

    Paragon Care has become recognized as a leading provider of equipment, devices and consumables to the healthcare market. We also offer equipment repair, maintenance and total equipment management through Paragon Care Service & Technology. Our agility and experience enable customers to provide the right solution to achieve the optimal outcome, today.

    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 about our success in selling Avenova in Australia 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 our ability to enter into the beauty market, find and maintain distribution channels, and generally all risks associated with launching a new product into the beauty industry. 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.

    Socialize and Stay informed on NovaBay's progress

    Like us on Facebook

    Follow us on Twitter

    Connect with NovaBay on LinkedIn

    Visit NovaBay's Website

    Avenova Purchasing Information

    For NovaBay Avenova purchasing information:

    Please call 800-890-0329 or email .

    Avenova.com

    View Full Article Hide Full Article
    • Revenue increased 34% versus prior year
    • Avenova® unit sales set quarterly record
    • Exited Q3 with $13.4 million in cash and equivalents
    • Regained compliance with NYSE American continued-listing standards
    • Launches CelleRx® Clinical Reset™ into beauty market

    Conference call begins at 4:30 p.m. Eastern time today

    NovaBay® Pharmaceuticals, Inc. (NYSE:NBY) reports financial results for the three and nine months ended September 30, 2020 and provides a business update.

    "This is an exceptionally exciting time at NovaBay as Avenova unit sales set a new quarterly record and we prepare for the consumer launch of CelleRx Clinical Reset into the beauty market," said Justin Hall, President and CEO of NovaBay Pharmaceuticals. "Product revenue for…

    • Revenue increased 34% versus prior year
    • Avenova® unit sales set quarterly record
    • Exited Q3 with $13.4 million in cash and equivalents
    • Regained compliance with NYSE American continued-listing standards
    • Launches CelleRx® Clinical Reset™ into beauty market

    Conference call begins at 4:30 p.m. Eastern time today

    NovaBay® Pharmaceuticals, Inc. (NYSE:NBY) reports financial results for the three and nine months ended September 30, 2020 and provides a business update.

    "This is an exceptionally exciting time at NovaBay as Avenova unit sales set a new quarterly record and we prepare for the consumer launch of CelleRx Clinical Reset into the beauty market," said Justin Hall, President and CEO of NovaBay Pharmaceuticals. "Product revenue for the quarter increased 34% to $2.2 million from the prior year, with Avenova revenue reaching its highest level since we introduced the direct-to-consumer channel. Online sales of Avenova Direct continued as the fastest-growing channel driven by our successful digital marketing programs featuring lifestyle messaging and increased customer outreach. Sales from our buy-and-sell channel also surged in recent months with the reopening of doctors' offices across the country.

    "Our groundbreaking product CelleRx Clinical Reset creates a new category in skin care," he added. "Previously we marketed CelleRx to only medical professionals without targeting the consumer market. With a completely new marketing approach for CelleRx Clinical Reset, we intend to leverage our pharmaceutical pedigree in the beauty industry. Clinical Reset disrupts the layer of bacteria that settles and grows on the face, yet is a gentle way to get skin back to a healthy baseline to heal itself and to better absorb skincare products. Clinical Reset's unveiling will include robust social media and print advertising campaigns targeted directly to the consumer market. Initial sales will be through our newly designed website, cellerx.com.

    "We exited the quarter with our strongest cash position since the commercial launch of Avenova in 2015 and have sufficient funds to support current operations through full year 2021, including our enhanced online advertising programs for Avenova and the consumer launch of CelleRx Clinical Reset. We raised $6.4 million in the third quarter from the renegotiation of warrants, which also enabled us to regain compliance with NYSE American continued-listing requirements," Mr. Hall added. "I'm proud of our many recent accomplishments as they position NovaBay for a bright future.

    "We continue actively working with the U.S. Food and Drug Administration (FDA) on a number of items. Our application for Emergency Use Authorization (EUA) to sell the fluorecare® rapid COVID-19 antibody test is still under review and we have successfully remediated the recent Warning Letter regarding our COVID-19 Avenova marketing. Lastly, we continue to work with the Environmental Protection Agency (EPA) on the inclusion of Avenova on its list of approved disinfectants that kill the COVID-19 virus on hard surfaces," concluded Mr. Hall.

    Third Quarter Financial Results

    Net product revenue for the third quarter of 2020 was $2.2 million, a 34% increase from $1.6 million for the third quarter of 2019. Avenova revenue for the third quarter of 2020 was $1.8 million, a 14% increase from $1.6 million for the third quarter of 2019. The increase reflects a higher number of Avenova Direct and buy-and-sell units sold, partially offset by a decrease in the number of units sold through our retail and partner pharmacy channels. The increase in revenue due to unit sales was partially offset by the lower average net selling price associated with Avenova Direct units. Net product revenue for the third quarter of 2020 also includes $0.2 million from the sales of a PhaseOne, a private-label prescription skin and wound care product, with no comparable revenue in the prior-year period.

    Gross margin on net product revenue remained unchanged at 75% for the third quarters of 2020 and 2019.

    Operating expenses for the third quarter of 2020 were $3.7 million, compared with $2.9 million for the third quarter of 2019. Sales and marketing expenses for the third quarter of 2020 were $1.7 million, compared with $1.5 million for the third quarter of 2019, reflecting an increase in Avenova digital advertising and costs associated with the consumer launch of CelleRx Clinical Reset, partially offset by lower headcount-related costs and lower travel and related expenses due to the impact of COVID-19. General and administrative (G&A) expenses for the third quarter of 2020 were $1.9 million, compared with $1.3 million for the third quarter of 2019, with the increase due to higher legal fees and the cost of the McGovern arbitration. Research and development (R&D) expenses for the third quarter of 2020 were $125,000, compared with $49,000 for the third quarter of 2019.

    Operating loss for the third quarter of 2020 was $2.1 million, compared with the operating loss of $1.7 million for the third quarter of 2019.

    Non-cash loss on the change of fair value of warrant liability for the third quarter of 2020 was $1.6 million, compared with a non-cash gain of $1.5 million for the third quarter of 2019.

    Non-cash gain from adjustments to the fair value of an embedded derivative liability for the third quarter of 2020 was $1,000, compared with $0.7 million for the third quarter of 2019.

    Other income, net, for the third quarter of 2020 of $0.4 million is primarily related to qualified expenses incurred under the Paycheck Production Program. This compares with other expense, net, of $0.7 million for the third quarter of 2019, which was due primarily to interest expense recognized on a convertible note that was settled prior to the end of the third quarter of 2020.

    The net loss for the third quarter of 2020 was $3.2 million, or $0.08 per share, compared with a net loss for the third quarter of 2019 of $282,000, or $0.01 per share.

    Nine Month Financial Results

    Net product revenue for the nine months ended September 30, 2020 was $8.0 million, a 66% increase from $4.9 million for the nine months ended September 30, 2019. Gross margin on net product revenue was 61% for the first nine months of 2020, compared with 77% for the first nine months of 2019.

    For the nine months ended September 30, 2020, sales and marketing expenses decreased 29% to $4.7 million, G&A expenses of $4.6 million increased 12% and R&D expenses of $0.2 million were relatively unchanged, compared with the nine months ended September 30, 2019.

    Operating loss for the first nine months of 2020 was $4.7 million, a 35% improvement from the operating loss of $7.2 million for the first nine months of 2019.

    Non-cash loss on the change of fair value of warrant liability for the first nine months of 2020 was $5.2 million, compared with a non-cash gain of $0.9 million for the first nine months of 2019.

    Non-cash gain from adjustments to the fair value of an embedded derivative liability for the nine months ended September 30, 2020 was $3,000, compared with $0.4 million for the nine months ended September 30, 2019.

    Other income, net, for the first nine months of 2020 was $0.6 million, compared with other expense, net, for the first nine months of 2019 of $1.2 million.

    The net loss for the nine months ended September 30, 2020 was $9.3 million, or $0.28 per share, compared with a net loss for the nine months ended September 30, 2019 of $7.0 million, or $0.36 per share.

    NovaBay reported cash and cash equivalents of $13.4 million as of September 30, 2020, compared with $6.9 million as of December 31, 2019. The Company raised net proceeds of $5.2 million from the sale of common stock through an ATM agreement during the quarter ended June 30, 2020 and $6.4 million from the renegotiation of warrants during the quarter ended September 30, 2020.

    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 866-677-7731 from within the U.S. or 480-405-6745 from outside the U.S., and requesting the NovaBay Pharmaceuticals call.

    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 the call ends through 11:59 p.m. Eastern time November 26, 2020 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 8439986.

    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, CELLERX® for the aesthetic dermatology market and NEUTROPHASE® for the wound care market. The Aganocide compounds, still under development, have target applications in the dermatology and urology markets.

    Forward-Looking Statements

    Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial progress and future financial performance of NovaBay Pharmaceuticals, Inc. 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 current product offerings, potential future product offerings, possible regulatory clearance of any of our products or future products, and any future revenue that may result from selling these products, as well as generally the Company's expected future financial results. These forward-looking statements are identified by the use of words such as "launch," "leverage," "position," and "continue," among others. 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, the possibility that the available market for the Company's products will not be as large as expected, the Company's products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to meet the Company's cash needs, the effect on sales and potential reputational damage resulting from decisions or actions taken by regulators, including Warning Letters issued by the FDA, and any other potential regulatory problems that may arise. 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.

    Socialize and Stay informed on NovaBay's progress

    Like us on Facebook

    Follow us on Twitter

    Connect with NovaBay on LinkedIn

    Visit NovaBay's Website

    Avenova Purchasing Information

    For NovaBay Avenova purchasing information:

    Please call 800-890-0329 or email .

    www.Avenova.com

    Financial tables to follow

    NOVABAY PHARMACEUTICALS, INC.

    CONSOLIDATED BALANCE SHEETS

    (in thousands, except par value amounts)

     

     

     

    September 30,

     

    December 31,

     

     

    2020

     

    2019

     

     

    (Unaudited)

     

     

    ASSETS

     

     

     

     

    Current assets:

     

     

     

     

    Cash and cash equivalents

     

    $

    13,413

     

     

    $

    6,937

     

    Accounts receivable, net of allowance for doubtful accounts ($0 and $51 at September 30, 2020 and December 31, 2019, respectively)

     

     

    1,119

     

     

     

    1,066

     

    Inventory, net of allowance for excess and obsolete inventory and lower of cost or estimated net realizable value adjustments ($194 and $247 at September 30, 2020 and December 31, 2019, respectively)

     

     

    785

     

     

     

    492

     

    Prepaid expenses and other current assets

     

     

    695

     

     

     

    886

     

    Total current assets

     

     

    16,012

     

     

     

    9,381

     

    Operating lease right-of-use assets

     

     

    518

     

     

     

    1,252

     

    Property and equipment, net

     

     

    76

     

     

     

    110

     

    Other assets

     

     

    476

     

     

     

    477

     

    TOTAL ASSETS

     

    $

    17,082

     

     

    $

    11,220

     

     

     

     

     

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

     

    Liabilities:

     

     

     

     

    Current liabilities:

     

     

     

     

    Accounts payable

     

    $

    796

     

     

    $

    331

     

    Accrued liabilities

     

     

    1,655

     

     

     

    1,778

     

    Operating lease liabilities

     

     

    400

     

     

     

    930

     

    Note payable, related party

     

     

    104

     

     

     

    1,202

     

    Convertible note

     

     

     

     

     

    1,409

     

    Other current liabilities

     

     

    48

     

     

     

    37

     

    Total current liabilities

     

     

    3,003

     

     

     

    5,687

     

    Operating lease liabilities-non-current

     

     

    197

     

     

     

    505

     

    Warrant liability

     

     

     

     

     

    4,055

     

    Total liabilities

     

     

    3,200

     

     

     

    10,247

     

     

     

     

     

     

    Stockholders' equity:

     

     

     

     

    Preferred stock: 5,000 shares authorized; none issued and outstanding at September 30, 2020 and December 31, 2019

     

     

     

     

     

     

    Common stock, $0.01 par value; 75,000 shares and 50,000 shares authorized at September 30, 2020 and December 31, 2019, respectively; 41,760 and 27,938 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively

     

     

    417

     

     

     

    279

     

    Additional paid-in capital

     

     

    147,774

     

     

     

    125,718

     

    Accumulated deficit

     

     

    (134,309

    )

     

     

    (125,024

    )

    Total stockholders' equity

     

     

    13,882

     

     

     

    973

     

    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

     

    $

    17,082

     

     

    $

    11,220

     

    NOVABAY PHARMACEUTICALS, INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (Unaudited)

    (in thousands except per share data)

     

     

     

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Sales:

     

     

     

     

     

     

     

     

    Product revenue, net

     

    $

    2,167

     

     

    $

    1,615

     

     

    $

    8,038

     

     

    $

    4,854

     

    Other revenue, net

     

     

    3

     

     

     

     

     

     

    8

     

     

     

    41

     

    Total sales, net

     

     

    2,170

     

     

     

    1,615

     

     

     

    8,046

     

     

     

    4,895

     

     

     

     

     

     

     

     

     

     

    Product cost of goods sold

     

     

    536

     

     

     

    401

     

     

     

    3,157

     

     

     

    1,145

     

    Gross profit

     

     

    1,634

     

     

     

    1,214

     

     

     

    4,889

     

     

     

    3,750

     

     

     

     

     

     

     

     

     

     

    Research and development

     

     

    125

     

     

     

    49

     

     

     

    249

     

     

     

    166

     

    Sales and marketing

     

     

    1,692

     

     

     

    1,544

     

     

     

    4,675

     

     

     

    6,610

     

    General and administrative

     

     

    1,879

     

     

     

    1,333

     

     

     

    4,633

     

     

     

    4,136

     

    Total operating expenses

     

     

    3,696

     

     

     

    2,926

     

     

     

    9,557

     

     

     

    10,912

     

    Operating loss

     

     

    (2,062

    )

     

     

    (1,712

    )

     

     

    (4,668

    )

     

     

    (7,162

    )

     

     

     

     

     

     

     

     

     

    Non-cash (loss) gain on changes in fair value of warrant liability

     

     

    (1,589

    )

     

     

    1,480

     

     

     

    (5,224

    )

     

     

    936

     

    Non-cash gain on changes in fair value of embedded derivative liability

     

     

    1

     

     

     

    669

     

     

     

    3

     

     

     

    423

     

    Other income (expense), net

     

     

    429

     

     

     

    (719

    )

     

     

    605

     

     

     

    (1,166

    )

     

     

     

     

     

     

     

     

     

    Loss before provision for income taxes

     

     

    (3,221

    )

     

     

    (282

    )

     

     

    (9,284

    )

     

     

    (6,969

    )

    Provision for income taxes

     

     

     

     

     

     

     

     

    (1

    )

     

     

    (3

    )

    Net loss and comprehensive loss

     

    $

    (3,221

    )

     

    $

    (282

    )

     

    $

    (9,285

    )

     

    $

    (6,972

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss per share attributable to common stockholders (basic)

     

    $

    (0.08

    )

     

    $

    (0.01

    )

     

    $

    (0.28

    )

     

    $

    (0.36

    )

    Net loss per share attributable to common stockholders (diluted)

     

    $

    (0.08

    )

     

    $

    (0.02

    )

     

    $

    (0.28

    )

     

    $

    (0.36

    )

    Weighted-average shares of common stock outstanding used in computing net loss per share of common stock (basic)

     

     

    40,037

     

     

     

    23,096

     

     

     

    32,614

     

     

     

    19,623

     

    Weighted-average shares of common stock outstanding used in computing net loss per share of common stock (diluted)

     

     

    40,067

     

     

     

    23,213

     

     

     

    32,642

     

     

     

    19,623

     

     

    View Full Article Hide Full Article
  4. Company enters beauty market with the launch of Clinical Reset as an expansion of the CelleRx brand

    NovaBay Pharmaceuticals, Inc. (NYSE:NBY) announces the consumer launch of Clinical Reset, an FDA-cleared skincare product proven to help clean and reduce the buildup of bacteria on facial skin. A patented spray solution, Clinical Reset creates a new category in beauty products by disrupting the layer of bacteria that settles and grows on the face, yet is a gentle way to get skin back to a healthy baseline to heal itself and to better absorb skincare products.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201112005362/en/

    CelleRx Clinical Reset (Photo: Business Wire)

    CelleRx Clinical Reset (Photo: Business Wire)

    The Clinical Reset…

    Company enters beauty market with the launch of Clinical Reset as an expansion of the CelleRx brand

    NovaBay Pharmaceuticals, Inc. (NYSE:NBY) announces the consumer launch of Clinical Reset, an FDA-cleared skincare product proven to help clean and reduce the buildup of bacteria on facial skin. A patented spray solution, Clinical Reset creates a new category in beauty products by disrupting the layer of bacteria that settles and grows on the face, yet is a gentle way to get skin back to a healthy baseline to heal itself and to better absorb skincare products.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201112005362/en/

    CelleRx Clinical Reset (Photo: Business Wire)

    CelleRx Clinical Reset (Photo: Business Wire)

    The Clinical Reset product is being launched under NovaBay's existing CelleRx brand and is initially available to consumers on cellerx.com. Broader distribution is expected in the future.

    Unlike many other skincare products, Clinical Reset is medical grade and made in the United States. It is formulated with NovaBay's patented, pure, prescription-grade hypochlorous acid (HOCl), the same molecule produced by the human body's immune system to fight infection and heal wounds. Clinical Reset is the only bleach-free HOCl skincare product on the market today. It keeps the skin's natural barrier intact, which when out of balance can allow acne, rosacea and infection to set in. Clinical Reset is complementary to a daily beauty regime for use on clean skin or over makeup.

    Spritzing the face with Clinical Reset can replace or augment a morning cleanse for dry sensitive skin, reduce bacteria after exercising, calm skin following microdermabrasion and other aesthetic facial procedures, combat environment aggressors or disinfect facial masks before or after use.

    NovaBay CEO Justin Hall said, "Prior to this consumer launch, our marketing of CelleRx focused on medical professionals only. With the rebranding, we intend to leverage new consumer focused messaging and the product's pharmaceutical pedigree in robust social media and print advertising campaigns marketing CelleRx Clinical Reset in the beauty industry. As we explored ways to expand the use of our patented, pure hypochlorous acid, we were fortunate to partner with Sarah Rutson in launching Clinical Reset. This opportunity allows us to expand into the beauty category, while capitalizing on years of research and development."

    Sarah Rutson, renowned for building successful brands in the fashion and beauty industries, will join Lena Xiao, an experienced consumer marketeer, serving as a consultant to NovaBay, in driving this initiative forward.

    "I've built a long career calling trends before they take off, building and buying every brand in the world for the global luxury market. It's rare to have the opportunity to create a whole new category. This is truly groundbreaking and sets a new standard for beauty," said Ms. Rutson. "This year taught the world that personal care and skincare are part of the same routine. While hand sanitizing has become the norm, until now no product existed to kill bacteria on the face throughout the day. Clinical Reset by CelleRx acts like a gentle, non-stripping sanitizer for the face."

    "It's exciting to identify a novel consumer use for pure HOCI. It enables access to an entirely new level of clinical research and rigor that is often missing from the traditional beauty industry," added Ms. Rutson.

    Making its debut in the traditional beauty press and with early access given to leading beauty industry influencers and executives, initial feedback indicates a strong appetite for this category. Like all NovaBay products, Clinical Reset is proudly American made and available on cellerx.com for $54.

    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 beauty 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 NYSE American listing status, our future momentum 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 our ability to enter into the beauty market, find and maintain distribution channels, and generally all risks associated with launching a new product into the beauty industry. 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.

    For more information visit https://cellerx.com.

    Socialize and Stay informed on NovaBay's progress

    Like us on Facebook

    Follow us on Twitter

    Connect with NovaBay on LinkedIn

    Visit NovaBay's Website

    Avenova Purchasing Information

    For NovaBay Avenova purchasing information:

    Please call 800-890-0329 or email .

    Avenova.com

    CelleRx Purchasing Information

    For NovaBay CelleRx purchasing information:



    cellerx.com

    View Full Article Hide Full Article
View All NovaBay Pharmaceuticals Inc. News