Crystal Research Associates has issued a 10-page Company Update on a commercial-stage biopharmaceutical company, Evofem Biosciences, Inc. (EVFM-NASDAQ).
Snapshot
Evofem Biosciences, Inc. (“Evofem” or “the Company”) is a commercial-stage biopharmaceutical company focused on addressing unmet needs within the women’s sexual and reproductive healthcare markets. The Company’s initial Food and Drug Administration (FDA)-approved product, Phexxi®, is a hormone-free, on-demand prescription contraceptive vaginal gel. Packaged in boxes containing twelve pre-filled applicators (like a tampon), Phexxi is inserted within one hour before intercourse and works to prevent pregnancy by maintaining the vaginal pH, which reduces sperm motility and lowers the chance of sperm reaching the egg. Evofem’s Phexxi has no systemic activity in the body, which is important to the 23 million women who are beyond using contraceptives containing hormones due to the pervasive side effects or risk of drug-drug interactions. These include women who may be breastfeeding or breast cancer patients/survivors, as well as those using GLP-1s for weight loss who need supplemental birth control because oral contraceptive pills are less effective at certain times of the GLP-1 dosing regimen. Evofem’s common stock trades on the OTCQB Venture Market under the ticker symbol “EVFM.”
Key Points of Evofem Biosciences, Inc.
- On August 14, 2024, Evofem reported its financial results for the second quarter and first half of 2024. For the three months ending June 30, 2024, net product sales reached $4.2 million, up from $2.5 million in the same period last year. This 69% increase is largely due to an unusually high volume of product returns in the prior year's quarter, a situation that did not occur in the current period. Additionally, an 8% rise in Phexxi ex-factory unit sales contributed to the year-over-year growth.
- Since April 1, 2024, the Company achieved the following milestones:
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- acquired global rights to SOLOSEC®, an FDA-approved single-dose oral antibiotic to treat bacterial vaginosis and trichomoniasis.
- licensed commercial rights for Phexxi® in the Middle East to Pharma 1 Drug Store.
- partnered with Hello Alpha to offer Phexxi as a hormone-free contraception option, particularly for women using GLP-1s, and negotiated a 7.4% rebate reduction on Phexxi prescriptions with Medi-Cal.
- launched a partnership with Modern Remedies for Phexxi distribution.
- strengthened its intellectual property with a fifth U.S. patent for Phexxi.
- received $2.0 million from Aditxt, Inc. related to the Merger Agreement; the merger is expected to close in late 2024.
- acquired global rights to SOLOSEC®, an FDA-approved single-dose oral antibiotic to treat bacterial vaginosis and trichomoniasis.
- Evofem has strong intellectual property protection: Phexxi is covered into at least 2033 by five Orange Book listed U.S. patents, while nine Orange Book-listed patents protect SOLOSEC® in U.S. through September 2035.
- Evofem is working to expand Phexxi’s global presence through licenses outside the U.S. The product is approved in Nigeria, with regulatory submissions in Ghana, Ethiopia, and Mexico. Pharma 1 is expected to file in UAE in the second half of 2024.
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