Lactic acid/citric acid/potassium bitartrate

Evofem Biosciences Announces Financial Results for the Third Quarter of 2023

Retrieved on: 
Tuesday, November 14, 2023
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SAN DIEGO, Nov. 14, 2023 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM) today announced financial results for the third quarter and nine months ended September 30, 2023. Highlights include:

Key Points: 
  • — Reduced loss from operations by 81% vs. Q3 2022 —
    SAN DIEGO, Nov. 14, 2023 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM) today announced financial results for the third quarter and nine months ended September 30, 2023.
  • Highlights include:
    $5.1 million in net product sales of Phexxi® (lactic acid, citric acid and potassium bitartrate) for the third quarter of 2023 and $13.4 million year-to-date 2023.
  • Third quarter total operating expenses were $8.7 million for 2023, a decrease of 65% as compared with the same period last year.
  • Narrowed loss from operations by 81% in the third quarter of 2023 as compared with the prior year quarter.

Evofem Biosciences Announces Preliminary Results for the Third Quarter of 2023

Retrieved on: 
Tuesday, October 24, 2023
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SAN DIEGO, Oct. 24, 2023 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFMD) ("Evofem") today announced preliminary results for the third quarter of 2023, including sequential growth in net product sales of its hormone-free prescription contraceptive gel, Phexxi® (lactic acid, citric acid and potassium bitartrate) and the positive impact of ongoing cost containment initiatives.

Key Points: 
  • Phexxi net product sales expected to be $5.0 to $5.2 million for the third quarter of 2023.
  • Selling and marketing expenses were more than 75% lower and total operating expenses were more than 65% lower in the third quarter of 2023 than the third quarter of 2022.
  • Reduced loss from operations by more than 80% in the third quarter of 2023 as compared to the third quarter of 2022.
  • The Company expects to report full unaudited results for the three- and nine- months ended September 30, 2023, in mid-November.

Evofem Announces Padagis Will Not Seek FDA Approval to Market a Generic Version of Phexxi® Until Evofem's Phexxi Patents Expire

Retrieved on: 
Wednesday, September 27, 2023
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SAN DIEGO, Sept. 27, 2023 /PRNewswire/ -- Evofem Biosciences, Inc., (OTCQB: EVFM) today announced that Padagis Israel Pharmaceuticals Ltd. (Padagis) has withdrawn the Paragraph IV certification in its previously-submitted Abbreviated New Drug Application (ANDA) for a generic version of Phexxi® (lactic acid, citric acid and potassium bitartrate) and has instead converted to a Paragraph III certification. With this pivot to Paragraph III certification, rather than challenging the Phexxi patents and seeking approval of the ANDA prior to expiration of any of those patents, Padagis is instead now asking the U.S. Food and Drug Administration (FDA) to wait until after all the Phexxi patents expire before issuing final approval of the ANDA. The latest-expiring Phexxi patents do not expire until 2033.

Key Points: 
  • With this pivot to Paragraph III certification, rather than challenging the Phexxi patents and seeking approval of the ANDA prior to expiration of any of those patents, Padagis is instead now asking the U.S. Food and Drug Administration (FDA) to wait until after all the Phexxi patents expire before issuing final approval of the ANDA.
  • Padagis previously submitted its ANDA in April 2023 requesting permission to manufacture and market a generic version of Phexxi.
  • That ANDA contained a Paragraph IV certification, in response to which Evofem initiated patent infringement litigation against Padagis.
  • ' All four patents would need to expire or be deemed invalid or not infringed before a generic version of Phexxi could be marketed.

Evofem Biosciences Reports Year-End 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Friday, April 28, 2023
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SAN DIEGO, April 28, 2023 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM), the maker of Phexxi® (lactic acid, citric acid and potassium bitartrate), has reported financial results for the year ended December 31, 2022.

Key Points: 
  • Appointed Ivy Zhang as Chief Financial Officer and Secretary effective April 13, 2023.
  • "In 2022, we more than doubled Phexxi revenue while cutting costs 42%.
  • For the year ended December 31, 2022, net product sales were $16.8 million compared to $8.2 million in net product sales in the prior year.
  • We decreased selling and marketing costs by 61% to $44.0 million in 2022, compared to $113.2 million in the prior year.

Evofem's Phexxi Contraceptive Gel Added to SimpleHealth Product Offering

Retrieved on: 
Tuesday, February 28, 2023
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SAN DIEGO, Feb. 28, 2023 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM) announced today that reproductive telehealth leader SimpleHealth now offers Phexxi® (lactic acid, citric acid and potassium bitartrate), the first and only hormone-free vaginal gel approved by the FDA for contraception.

Key Points: 
  • "This partnership with SimpleHealth will increase awareness of Phexxi and provide access to the only non-hormonal birth control women use on demand," said Saundra Pelletier, Chief Executive Officer of Evofem.
  • "This beneficial alliance "meets" women where they are and delivers on our strategy to expand access to Phexxi."
  • We are proud to offer Phexxi to meet the needs of the many women who want or need a non-hormonal birth control method," said Carrie Siu Butt, Chief Executive Officer of SimpleHealth.
  • The SimpleHealth offering includes contraceptive counseling, resources, and education about women's health as well as online prescriptions, automatic refills and free home delivery of more than 120 brand name and generic products including hormonal birth control – pill, patch or ring – and now hormone-free Phexxi contraceptive vaginal gel.

Costco Adds Phexxi® to Member Prescription Program

Retrieved on: 
Tuesday, January 10, 2023
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"This program enables Costco members with no insurance or whose plans have denied coverage to fill their Phexxi prescriptions at a reduced cost."

Key Points: 
  • "This program enables Costco members with no insurance or whose plans have denied coverage to fill their Phexxi prescriptions at a reduced cost."
  • The Costco Member Prescription Program is a prescription drug discount card program that provides eligible Costco members and their eligible dependents the ability to obtain lower prices on Phexxi and other participating drugs at participating pharmacies.
  • Costco members who are uninsured and want to pay cash for their Phexxi prescription, or who have been denied coverage by their insurer, may use this program to fill their Phexxi prescriptions for less than the typical cash pay cost.
  • The pricing available through the discount card applies at their local Costco pharmacies, Costco mail order and thousands of participating neighborhood pharmacies.

Multiple New Insurance Wins Expand and Improve Access to Phexxi® for Millions of Women

Retrieved on: 
Monday, January 9, 2023
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SAN DIEGO, Jan. 9, 2023 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM) today announced multiple new insurance wins that give millions of additional women access to Phexxi® (lactic acid, citric acid, potassium bitartrate) for the hormone-free prevention of pregnancy.

Key Points: 
  • "Evofem's unrelenting focus and engagement with payers continues to deliver results, expanding and improving access to Phexxi for millions of women across the country," said Saundra Pelletier, Chief Executive Officer of Evofem.
  • Three recent Medicaid wins move Phexxi to a Preferred formulary position with no restrictions, improving Phexxi coverage for more than 3.7 million lives in 11 states.
  • This change improved Phexxi coverage for approximately 3 million lives in nine states: Georgia, New York, New Jersey, Virginia, Maryland, Indiana, Nevada, Nebraska and Florida.
  • The HRSA guidelines currently in effect were issued in 2019 and require broad coverage of contraceptive care and services for women.

Evofem Biosciences Announces Uplisting to OTCQB

Retrieved on: 
Monday, October 3, 2022
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SAN DIEGO, Oct. 3, 2022 /PRNewswire/ -- Evofem Biosciences, Inc.,(OTCQB: EVFM) announced today that the trading of its common shares has been upgraded to the OTCQB Venture Market from the OTC Pink Open Market.

Key Points: 
  • SAN DIEGO, Oct. 3, 2022 /PRNewswire/ -- Evofem Biosciences, Inc.,(OTCQB: EVFM) announced today that the trading of its common shares has been upgraded to the OTCQB Venture Market from the OTC Pink Open Market.
  • The OTCQB Venture Market provides investors an exchange-comparable information experience with convenient trading through their preferred broker or financial advisor.
  • Evofem Biosciences, Inc. is developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health.
  • Phexxiis a registered trademark of Evofem Biosciences, Inc.

Evofem Announces Issuance of U.S. Patent Covering Phexxi® Composition of Matter

Retrieved on: 
Friday, September 23, 2022
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SAN DIEGO, Sept. 23, 2022 /PRNewswire/ -- Evofem Biosciences (OTCPK: EVFM) today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,439,610, which covers the composition of matter of Phexxi® (lactic acid, citric acid, potassium bitartrate).  

Key Points: 
  • 11,439,610, which covers the composition of matter of Phexxi (lactic acid, citric acid, potassium bitartrate).
  • "We are extremely pleased with the continued development of the Phexxi patent portfolio, which comprises more than 40 patents.
  • Top-line data from EVOGUARD, Evofem's registrational Phase 3 clinical trial evaluating Phexxi for these two potential new indications, are expected in mid-October.
  • Evofem now has the sole right in the United States to make, have made, market, and sell for any commercial purpose the composition of matter that comprises Phexxi.

Large Commercial Payer Adds Phexxi® to Formulary for Standard Plans Nationwide

Retrieved on: 
Friday, September 16, 2022
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SAN DIEGO, Sept. 16, 2022 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCPK: EVFM) today announced another new insurance win that gives millions of additional women access to Phexxi® (lactic acid, citric acid, potassium bitartrate) for the prevention of pregnancy.

Key Points: 
  • "Evofem's diligent efforts to expand access to Phexxi nationwide continue to pay off," said Saundra Pelletier, Chief Executive Officer of Evofem.
  • "We are thrilled that another highly respected national-level payer is now covering Phexxi, allowing women to fill their prescriptions immediately.
  • Evofem consistently engages with these payers to ensure they comply with these guidelines in covering Phexxi.
  • If you have a history of urinary tract problems that keep coming back, you should not use Phexxi.