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Evofem Biosciences (EVFM) Misses Q2 EPS by 54c

August 4, 2020 8:07 AM EDT

Evofem Biosciences (NASDAQ: EVFM) reported Q2 EPS of ($0.91), $0.54 worse than the analyst estimate of ($0.37).

Second quarter and recent highlights include:

  • Received U.S. Food and Drug Administration (FDA) approval of Phexxi™ (lactic acid, citric acid and potassium bitartrate) for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception;
  • Strengthened the balance sheet with approximately $136 million in gross proceeds from two financing transactions during an incredibly challenging time in the financial markets;
  • Both Medi-Span and First Databank, the two major drug information compendiums where the majority of payers obtain pricing and product information, have granted Phexxi new classification in their databases and pricing compendia as the first and only "Vaginal pH Modulator";
  • Met with all major commercial payers and garnered early formulary inclusion of Phexxi at $0 copay from several regional insurers;
  • Ongoing publication and presentation of data from the Phase 3 AMPOWER study of Phexxi for prevention of pregnancy, including peer-reviewed publication of the pivotal AMPOWER study results in Contraception; and,
  • Participated in a productive End-of-Phase 2 meeting with the FDA, which supported and informed the Company's pivotal Phase 3 clinical trial design for EVO100 for the prevention of urogenital chlamydia and gonorrhea in women; study to be initiated in the fourth quarter of 2020.

"The second quarter of 2020 was marked by success across all areas of our business. With the FDA approval of Phexxi in hand, more than $130 million in gross proceeds from our two financing transactions on the books, and clear guidance from the FDA regarding the clinical path forward for EVO100, we are operating from a position of strength with a clear vision for the future," said Saundra Pelletier, Evofem's Chief Executive Officer. "We are now intensely focused on the successful commercial launch of Phexxi in September and ensuring the team's ongoing excellence in execution with manufacturing timelines, payer coverage, sales force recruitment and the build-out of our unique telemedicine platform — the Phexxi Concierge Experience. It's going to be an exciting third quarter."

For earnings history and earnings-related data on Evofem Biosciences (EVFM) click here.



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