Potassium hydroxide

-- 2024 Net Sales Increased 6% to $19.4 Million -- -- Total Operating Expense Reduced 27% from 2023 Levels, Excluding Non-cash Amortization Expense -- -- Sales and Marketing Expense as a Percentage of Net Sales was 47% for 2024 and 31% for the Fourth Quarter, the Most Favorable Ratios since the PHEXXI Launch -- SAN DIEGO, March 24, 2025 /PRNewswire/ -- Women's health innovator Evofem Biosciences, Inc. (OTCQB: EVFM), today announced financial results for the fourth quarter and year ended December 31, 2024. Highlights include: Delivered $19.4 million of net sales in 2024, a 6% increase compared to 2023, despite ongoing fiscal constraints. 1) The vast majority of 2024 net sales were contributed by PHEXXI® (lactic acid, citric acid, and potassium bitartrate) vaginal gel, Evofem's hormone-free, on demand contraceptive. 2) The Company diversified its revenue stream with the July 2024 acquisition of SOLOSEC® (secnidazole) 2g oral granules, the single-dose oral treatment for bacterial vaginosis and trichomoniasis. Evofem relaunched SOLOSEC in November 2024 through its dedicated U.S. women's health commercial team. Sales and marketing expense was 47% of net sales for 2024, a key milestone for the Company. This compares favorably to prior year sales and marketing expense-to-net sales ratios of 64% in 2023 and 261% in 2022. Improved loss from operations by 57% compared to 2023 levels. Evofem, Aditxt, Inc. (NASDAQ: ADTX), and Merger Sub entered into the fifth amendment (the Fifth Amendment) to the Amended and Restated Merger Agreement, as amended (the A&R Merger Agreement). Under the Fifth Amendment: i) Aditxt is to fund $1.5 million to Evofem on or before April 7, 2025; ii) Evofem is to hold a special meeting of stockholders to seek approval of the transactions contemplated by the A&R Merger Agreement (collectively the Merger) no later than September 26, 2025; and, iii) The Merger is to be consummated by September 30, 2025. Advanced strategy to reduce PHEXXI manufacturing costs through sourcing partnership with Windtree Therapeutics, Inc., (NasdaqCM: WINT) aimed at improving Evofem's U.S. operating margins and driving profitability while facilitating entry into new global markets for our non-hormonal contraceptive vaginal gel. "Our revenue growth and improved loss from operations in 2024 testify to the strength and persistence of this company. Our products matter, our people are tenacious, and we continue to deliver results and overcome obstacles," said Saundra Pelletier, CEO of Evofem Biosciences. "In 2025, our strategy is to drive domestic sales growth with our innovative products – PHEXXI and SOLOSEC. Having two revenue generating FDA-approved products mitigates market risk for investors, increasing our ability to surmount the unforeseen challenges that dismantle one-product companies." Full Year Financial Results For the year ended December 31, 2024, net sales were $19.4 million compared to $18.2 million in the prior year. The increase was primarily driven by lower returns, leading to a better gross to net ratio, and the PHEXXI wholesale average cost (WAC) increase which took effect January 1, 2024. The addition of SOLOSEC net sales also contributed. Total operating expense was $27.0 million, compared to $36.1 million in the prior year. Excluding a non-cash amortization expense of $0.6 million related to the SOLOSEC acquisition, 2024 total operating expense was $26.4 million, a 27% decrease which reflects the Company's fiscal discipline in all areas of the business. We reduced selling and marketing costs by 21%, from $11.7 million in 2023 to $9.2 million in 2024. We reduced our general and administrative costs by 23% from $15.0 million in 2023 to $11.6 million in 2024, primarily by cutting facilities and outside services costs by $3.6 million and reducing legal- and finance-related professional services fees by $1.2 million in 2024. Research and development costs decreased by 37%, from $2.9 million in 2023 to $1.8 million in 2024. Sales and marketing expense as a percentage of net sales was 47% for 2024, the most favorable annual ratio since the PHEXXI launch in 2020. Loss from operations improved to $7.7 million in 2024, compared to a loss from operations of $17.8 million in the prior year. The Company recorded a net loss of $8.9 million in 2024. This compares to net income of $53.0 million reported in 2023, which was due to the large gain on extinguishment of debt; this is not a regularly occurring event and, as such, skewed the 2023 income and year over year comparison. Fourth Quarter Financial Results For the three months ended December 31, 2024, net sales were $7.1 million compared to $4.8 million in the prior year period. The increase was driven by the higher magnitude of PHEXXI sales ahead of the WAC increase that took effect January 1, 2025 as compared to the prior year quarter, the higher WAC in the 2024 period, and the expansion of Evofem's revenue stream to include sales of SOLOSEC, which Evofem acquired in July 2024 and relaunched in the U.S. in November 2024. Total operating expenses decreased 1% to $8.1 million, versus $8.2 million in the prior year period. Lower selling and marketing and research and development costs in the fourth quarter of 2024 were partially offset by higher COGS and amortization expense related to the SOLOSEC acquisition. Going forward, the amount of this amortization will adjust each quarter along with the fair value adjustment. Sales and marketing expense as a percentage of net sales was 31% for the fourth quarter of 2024, the most favorable quarterly ratio since the PHEXXI launch in 2020. Loss from operations improved to $1.0 million, compared to a loss from operations of $3.4 million in the fourth quarter of 2023. The Company recorded a net loss of $3.0 million in the fourth quarter of 2024, which includes a non-cash impairment on construction in-process equipment of $0.7 million, versus a net loss of $2.1 million reported in the fourth quarter of 2023. Liquidity In October 2024, Evofem raised $2.7 million in aggregate net proceeds through the sale and issuance of 2,740 shares of Series F-1 Convertible Preferred Stock to Aditxt, Inc., pursuant to the Amended and Restated Merger Agreement, as amended, between the companies. Evofem used a portion of this funding to pay in full its obligations to the U.S. Food and Drug Administration. As of December 31, 2024, the Company had $0.7 million of restricted cash, as compared to $0.6 million of restricted cash at December 31, 2023. About Evofem Biosciences Evofem Biosciences, Inc., is commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company's first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. In July 2024 Evofem broadened its commercial offering with the acquisition of SOLOSEC® (secnidazole) 2g oral granules, an FDA-approved oral antibiotic for the treatment of two sexual health diseases: bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. SOLOSEC provides a complete course of therapy in just one dose. Phexxi® and SOLOSEC® are registered trademarks of Evofem Biosciences, Inc. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 including, without limitation, statements related to the Company's anticipated financial performance. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 24, 2025, and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law. Investor Contact Amy Raskopf Evofem Biosciences, Inc. araskopf@evofem.com Mobile: (917) 673-5775 Financial tables follow EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (In thousands) As of December 31, 2024 2023 Cash and cash equivalents $ - $ - Restricted cash $ 741 $ 580 Trade accounts receivable, net $ 9,832 $ 5,738 Total current liabilities $ 80,448 $ 72,463 Total stockholders' deficit $ (71,257) $ (66,510) Total liabilities, convertible and redeemable preferred stock and stockholders' deficit $ 23,789 $ 10,554 EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (In thousands, except share and per share data) Three Months Ended December 31, Twelve Months Ended December 31, 2024 2023 2024 2023 Product sales, net $ 7,104 $ 4,839 $ 19,363 $ 18,218 Operating Expenses: Cost of goods sold 1,512 954 3,834 6,512 Amortization of intangible asset 318 - 619 - Research and development 649 1,383 1,845 2,939 Selling and marketing 2,206 2,628 9,176 11,664 General and administrative 3,422 3,254 11,565 14,950 Total operating expenses 8,107 8,219 27,039 36,065 Loss from operations (1,003) (3,380) (7,676) (17,847) Other income (expense): Interest income 3 3 16 31 Other expense, net (839) (587) (2,575) (2,628) Loss on issuance of financial instruments - (1,490) (3,300) (6,776) Gain on debt extinguishment, net - - 977 75,337 Change in fair value of financial instruments (1,198) 3,340 3,698 4,879 Total other income (expense), net (2,034) 1,266 (1,184) 70,843 Income (loss) before income tax (3,037) (2,114) (8,860) 52,996 Income tax expense - - - (17) Net income (loss) (3,037) (2,114) (8,860) 52,979 Convertible preferred stock deemed dividends (6) (2,984) (105) (2,984) Net income (loss) attributable to common stockholders $ (3,043) $ (5,098) $ (8,965) $ 49,995 Net (loss) per share attributable to common stockholders: Basic $ (0.03) $ (0.44) $ (0.12) $ 10.36 Diluted $ (0.03) $ (0.44) $ (0.12) $ 0.05 Weighted-average shares used to compute net income (loss) per share attributable to common shareholders: Basic 105,785,814 11,659,066 75,195,615 4,826,763 Diluted 105,785,814 11,659,066 75,195,615 984,038,574 SOURCE Evofem Biosciences, Inc.

Transaction is part of the Company’s new corporate strategy to become a revenue generating biotech WARRINGTON, Pa., March 20, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating biotech and advancing early and late-stage innovative therapies for critical conditions and diseases, is pleased to announce that it has entered into a License and Supply Agreement to become the sourcing partner for Evofem Biosciences, Inc. (OTCQB: EVFM) for one of Evofem’s FDA-approved products -- PHEXXI® (lactic acid, citric acid and potassium bitartrate). The product is a first-in-class hormone-free, on-demand prescription contraceptive vaginal gel that women control. PHEXXI annual revenues have grown to more than $19 million with more than 96,000 boxes of 12 pre-filled applicators sold in full year 2024. Windtree has manufacturing contacts that we believe are capable of reducing pharmaceutical product cost of goods for PHEXXI. Pursuant to the License and Supply Agreement, Windtree will serve as the sourcing partner to Evofem and aims to help generate profitable revenue by contracting with the manufacturer to produce PHEXXI at a cost that is significantly below current levels. Evofem will maintain ownership of the asset and continue to commercialize PHEXXI in the United States and internationally through strategic partnerships. “Windtree announced our new corporate strategy to become a revenue generating biotech in January 2025,” said Jed Latkin, CEO of Windtree. “This License and Supply Agreement with Evofem is a first step in our plan to generate profitable revenue to provide value to our stockholders. Using our extensive contacts across the globe, we have engaged with a pharmaceutical manufacturer on the plan to produce PHEXXI. We look forward to this opportunity. We anticipate that our manufacturing partner will work with us as we do the tech transfer and manufacture the initial batches and the validation batches in line with the FDA requirements.” “Global expansion of PHEXXI has always been a critical mandate for Evofem, but a significant hurdle has been high manufacturing costs which make commercialization cost-prohibitive in many markets outside of the U.S.,” said Saundra Pelletier, CEO of Evofem. “The meaningful decrease in the per-box cost of PHEXXI that we expect to achieve with Windtree’s assistance should allow Evofem to take PHEXXI into new, price-sensitive global markets where there is great need for non-hormonal contraceptives that women control. Our goal is to empower women; and to have PHEXXI available in all markets around the world is a big step in that direction.” [Saundra Pelletier is the President and Chief Executive Officer of Evofem, and is Interim Chair of Evofem’s board of directors, and also serves on Windtree’s board of directors.] About Windtree Therapeutics, Inc. Windtree Therapeutics, Inc. is a biotechnology company focused on becoming a revenue generating biotech and advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase 2 candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place. Forward Looking Statements This press release contains statements related to Windtree serving as a sourcing partner to Evofem; potential future positive revenue generation; manufacturing capabilities; decreasing the cost of PHEXXI; and Evofem taking PHEXXI into new global markets. Such statements constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include, among other things: the Company’s ability to acquire revenue generating subsidiaries; the market’s reaction to potential acquisitions by the Company; the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to achieve the intended benefits of the aPKCi asset acquisition with Varian Biopharmaceuticals, Inc.; the Company’s risks and uncertainties associated with the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates, including preclinical oncology candidates; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the U.S. Food and Drug Administration or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks that the Company may never realize the value of its intangible assets and have to incur future impairment charges; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates, if approved; the economic and social consequences of the COVID-19 pandemic and the impacts of political unrest, including as a result of geopolitical tension, including the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and the evolving events in the Middle East, and any sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company’s operations, including through disruption in supply chain or access to potential international clinical trial sites, and through disruption, instability and volatility in the global markets, which could have an adverse impact on the Company’s ability to access the capital markets. These and other risks are described in the Company’s periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Contact Information: Eric Curtis ecurtis@windtreetx.com