Secnidazole

-- 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.

-- Allowed Patent Extends SOLOSEC IP to 2040 with Broad Claims that are Orange Book-listable -- SAN DIEGO, Feb. 13, 2025 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM) today announced that the United States Patent and Trademark Office (USPTO) issued to the Company a Notice of Allowance for patent application 17/028,838, entitled "Method and Pharmaceutical Composition for Treating or Preventing Trichomoniasis and Uses Thereof." This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed. "This new U.S. patent extends SOLOSEC's IP protection by a full five years, from 2035 to 2040," said Saundra Pelletier, Chief Executive Officer of Evofem. "This extension, for the treatment of trichomoniasis, significantly benefits prescribers, patients, and our investors with a longer opportunity to build the SOLOSEC brand with its single-dose regimen." The allowed patent application is directed to treatment of Trichomonas vaginalis infections (trichomoniasis) with SOLOSEC® (secnidazole) 2 g oral granules, with broad claims centered on pharmacokinetics and formulation features of Evofem's single-dose oral antimicrobial agent. Evofem expects the resulting patent will be Orange Book-listable. Trichomoniasis is the most common non-viral sexually transmitted infection in the world. There are an estimated 6.9 million new infections with T. vaginalis in the U.S. each year.1 Undiagnosed infections and lack of compliance with multi-day treatment regimens are critical contributing factors. All sexual partners of people infected with trichomoniasis should be treated with the same dose and at the same time to prevent reinfection. SOLOSEC® is designed to be easy to take; one oral dose contains a complete course of treatment. SOLOSEC is the first and only single-dose oral antibiotic FDA-approved to treat bacterial vaginosis (BV) in females 12 years of age and older as well as trichomoniasis in people 12 years of age and older. Evofem acquired global rights to the product in July 2024 and relaunched SOLOSEC in the U.S. in November 2024 with its women's health-focused commercial team. About Trichomoniasis Trichomoniasis (or "Trich") is a sexually transmitted infection (STI) caused by infection with Trichomonas vaginalis, a protozoan parasite. It is the most common nonviral STI globally. Up to 70% of people infected with Trich are unaware that they are infected and may unwittingly pass the parasite to sexual partners. Untreated infections might last from months to years. In women, Trich can cause a foul-smelling vaginal discharge, genital itching, and pain with urination or sex. Trich is also associated with an increased risk for cervical cancer, HIV acquisition, and, among women with HIV infection, pelvic inflammatory disease (PID). Pregnant women who have Trich may be at higher risk of delivering their babies prematurely. Men who have Trich typically have no symptoms, however when men do have symptoms these may include itching or irritation inside the penis, burning with urination or after ejaculation, and discharge from the penis.2 About Evofem Biosciences Evofem 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. Follow us on: LinkedIn: Facebook: X (f/k/a Twitter): 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. 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, 2023 filed with the SEC on March 27, 2024, Quarterly Report on Form 10-Q for the three months ended September 30, 2024 filed with the SEC on November 14, 2024, 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. Contact Amy Raskopf, Chief Business Development Officer Evofem Biosciences, Inc. [email protected] (917) 673-5775 Sources Kreisel KM et al. Sexually Transmitted Infections Among US Women and Men: Prevalence and Incidence Estimates, 2018. Sex Transm Dis. 2021 Apr 1;48(4):208-214. doi: 10.1097/OLQ.0000000000001355. PMID: 33492089; PMCID: PMC10245608. Mayo Clinic. Diseases & Conditions: Trichomoniasis. 17 May 2022. Accessed 5 Nov 2024 at . SOURCE Evofem Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED