Evofem Biosciences, Inc. (NASDAQ: EVFM) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women’s sexual and reproductive health. Evofem is leveraging its proprietary Multipurpose Vaginal pH Regulator (MVP-R) to develop product candidates for multiple indications, including the prevention of pregnancy, the prevention of urogenital transmission of chlamydia and gonorrhea in women and the prevention of recurrent bacterial vaginosis.
On Nov. 07, 2018, the company announced its financial results for the quarter ended September 30, 2018 and provided an update on its operations and upcoming milestones. EVFM have made significant progress this quarter in its clinical programs evaluating Amphora for critical areas in women’s health where current options are either insufficient or absent entirely.
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The Company will have top line Phase 3 data for Empower, at the end of this year and with the positive outcome of its ongoing trial, the company expect to re-file the NDA for Amphora in the second quarter of 2019, which positions the company for FDA action in late 2019 and assuming approval, it will commercialize in January of 2020.
Recent Achievements and Highlights:
- Last patient visit is imminent in AMPOWER, the second Phase 3 trial of Amphora, its lead Multipurpose Vaginal pH Regulator (MVP-R) product candidate, for non-hormonal birth control; anticipating top-line results by year-end 2018;
- Completed ‘User Experience Satisfaction Survey’ among women who completed AMPOWER along with their male partners; and,
- Advanced patient enrollment in Phase 2b clinical trial evaluating the ability of Amphora to prevent urogenital acquisition of Chlamydia trachomatis (primary endpoint) and Neisseria gonorrhea (secondary endpoint) in women (AMPREVENCE).
- Top-line data are expected by year-end 2018 from the second Phase 3 clinical trial of Amphora for prevention of pregnancy (AMP002). Assuming positive results, the Company expects:
- To re-submit the Amphora New Drug Application (NDA) in Q2 2019;
- FDA decision on NDA in Q4 2019 (six-month review);
- To commercialize Amphora in early 2020 as the first and only hormone-free, woman-controlled, ‘only when she needs it’ birth control method (assuming approval).
Assuming positive results, Evofem will re-submit the Amphora New Drug Application in the second quarter of 2019. Pending FDA approval, the company expects to launch Amphora in January 2020 as the first and only non-hormonal, on-demand, woman-controlled prescription birth control method in the U.S. If approved, Amphora will be the first innovation in birth control brought to market since the vaginal ring and transdermal patch in 200
Evofem is also conducting a Phase 2b study, AMPREVENCE, to evaluate Amphora for prevention of certain sexually transmitted diseases. AMPREVENCE is actively enrolling women at U.S. study centers.
Analyst ratings and target price:
Per www.marketbeat.com, Their average twelve-month price target is $10.40, suggesting that the stock has a possible upside of 193.79%. The high price target for EVFM is $15.00, and the low-price target for EVFM is $8.00. There are currently five buy ratings for the stock, resulting in a consensus rating of “Buy.”
Below are the excerpts of recent analyst rating/Price targets on the company:
About Amphora®: Amphora (L-lactic acid, citric acid, and potassium bitartrate) is an investigational Multi-Purpose Vaginal pH Regulator (MVP-R) designed to regulate vaginal pH within the normal range of 3.5 to 4.5. This maintains an acidic environment which is inhospitable to sperm as well as certain viral and bacterial pathogens associated with sexually transmitted infections but is integral to the survival of healthy bacteria in the vagina.
Market potential and key demand drivers:
- The Company believes that Amphora is the appropriate birth control for many of the 16.5 million women in the U.S. who are not using any form of birth control but do not wish to get pregnant – a population which has indicated significant demand per the Company’s market research. Women who quit their reversible contraception and do nothing for birth control but continue to be sexually active have an 85 percent risk of becoming pregnant within a year.
- If approved by the FDA Amphora will be the first new and innovative birth control method in almost 20 years. It’s unlike anything that has come before it, which makes any comparison to existing therapies very difficult.
- The management believes that the women whose priorities are avoiding hormone, healthy living or who finds side effects of hormonal method unbearable are going to be very attracted to a more natural birth control option that EVFM is going to offer in MVP-R Amphora.
- Also, Amphora’s vaginal pH regulating properties may also be able to prevent the transmission of certain STDs including chlamydia and gonorrhea. The CDC recently reported that rates of gonorrhea and chlamydia have climbed for the fourth consecutive year in the US with nearly 2.3 million cases in 2017.
Financial Results (In thousands):
For the three months ended September 30, 2018, total operating expense was $18.4 million, compared to a total operating expense of $9.1 million for the three months ended September 30, 2017.
Net Loss: Net loss attributable to common stockholders was $110.8 million, or $(5.38) per share, for the nine months ended September 30, 2018, compared with a net loss of $88.7 million, or $(45.23) per share, for the prior year period.
Liquidity and financial flexibility: Unrestricted cash was $12.1 million at September 30, 2018, as compared to $22.8 million at June 30, 2018. With the treatment and follow-up phase of the AMPOWER study now complete, the Company expects its quarterly cash burn will decrease to approximately $7 to 9 million during the fourth quarter of 2018.
Key Stock Influences:
- Successful completion of the upcoming milestones would lead future direction for the company. Any adversities related to these upcoming milestones might adversely impact the overall investor sentiments.
- EVFM is still an early stage entity and has not yet generated meaningful revenue and will likely operate at a loss as it grows its market position and seeks ways to monetize it.
- EVFM has a history of operating losses. Therefore, any time or cost overrun in its ongoing R&D activities and its impact on business & financial profile will remain a key business sensitivity factor.
- On Friday January 4th , EVFM was at $3.89 on volume of 10.3K shares exchanging hands. Market capitalization is $90.535 million. The current RSI is 52.23
- In the past 52 weeks, shares of EVFM have traded as low as $1.7920 and as high as $12.9
- At $3.89, shares of EVFM are trading above its 50-day moving average (MA) at $3.63 and below its 200-day MA at $4.05
- The present support and resistance levels for the stock are at $3.30 & $3.94 respectively.
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