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Mar 31, 2020
Evofem Biosciences Q1 2020 Earnings Report
Evofem Biosciences reported financial results for the first quarter of 2020 and provided a corporate update.
Key Takeaways
Evofem Biosciences reported a net loss of $19.1 million for the first quarter of 2020. The company is preparing for the potential launch of Phexxi in early September and had $10.3 million in unrestricted cash and short-term investments as of March 31, 2020.
Total operating expenses increased 41% to $19.2 million due to pre-commercialization efforts for Phexxi.
Research and development costs decreased by 47% to $4.2 million due to the completion of clinical phases for AMPOWER and AMPREVENCE trials.
Selling and marketing costs were $7.9 million, an increase driven by pre-commercialization marketing expenses.
Net loss was $19.1 million, or $(0.40) per share, compared to a net loss of $18.1 million, or $(0.67) per share, for the prior year quarter.
Evofem Biosciences
Evofem Biosciences
Forward Guidance
Evofem Biosciences is on track for the Phexxi PDUFA date of May 25, 2020, and anticipates a commercial launch in early September. A meeting with the FDA is scheduled to review results of the AMPREVENCE Trial.
Positive Outlook
- Potential FDA approval of Phexxi on May 25, 2020
- Planned commercial launch of Phexxi in early September
- Ongoing discussions with the FDA regarding the potential label for Phexxi
- Strategic financing agreement for up to $25 million
- Meeting with FDA to discuss AMPREVENCE study results
Challenges Ahead
- COVID-19 impacted the healthcare landscape, causing a delay in the Phexxi commercial launch
- Dependence on FDA approval for Phexxi
- Risks and uncertainties associated with forward-looking statements
- Potential for actual results to differ materially from forward-looking statements
- Uncertainties regarding the clinical path for EVO100