On 13 May 2020, Evofem Biosciences, Inc. (NASDAQ: EVFM) changed 1.58% to recent value of $5.14. The stock transacted 585179 shares during most recent day however it has an average volume of 191.81K shares. It spotted trading -31.47% off 52-week high price. On the other end, the stock has been noted 53.89% away from the low price over the last 52-weeks.
Evofem Biosciences, Inc. (EVFM) recently stated financial results for the three- and twelve- month periods ended December 31, 2019.
The Company also reported that the FDA granted conditional authorization for the brand name Phexxi™ (L-lactic acid, citric acid, potassium bitartrate) Vaginal Gel 1.8%/1%/0.4% on February 25, 2020. With this authorization, the Company will now refer to its Multipurpose Vaginal pH Regulator (MVP-R™) candidate as Phexxi for the prevention of pregnancy and EVO100 for the prevention of chlamydia and gonorrhea.
“The Evofem team’s exceptional execution in 2019 laid the groundwork for what will be a transformative year for the Company,” stated Saundra Pelletier, Chief Executive Officer, Evofem Biosciences. “We are rapidly approaching the established FDA PDUFA date for our innovative, hormone-free, investigational contraceptive gel, which we are thrilled to share is now branded as Phexxi.
Fourth quarter and recent highlights include:
- Resubmitted the NDA for Phexxi for the prevention of pregnancy and received a six-month review and Prescription Drug User Fee Act (PDUFA) goal date of May 25, 2020 from the FDA.
- Stated positive, statistically important top-line results from the Phase 2b AMPREVENCE study evaluating EVO100 for the prevention of chlamydia and gonorrhea in women. The study met its primary and secondary endpoints, demonstrating a 50% relative risk reduction in chlamydia infection and a 78% relative risk reduction in gonorrhea infection contrast to placebo.
- Three abstracts from the Phase 3 AMPOWER trial of Phexxi for prevention of pregnancy accepted for poster presentation at the American College of Obstetricians and Gynecologists’ yearly meeting.
- Designated Lisa Rarick, M.D., F.A.C.O.G., former FDA Division Director for the Division of Reproductive and Urologic Products, to the Company’s Board of Directors.
- Granted end-of-phase 2 meeting with the FDA to discuss AMPREVENCE study results and determine the clinical and regulatory path forward for EVO100.
Fourth Quarter Financial Results
For the quarter ended December 31, 2019, total operating expenses reduced 14% to $12.9M, contrast to $15.0M for the quarter ended December 31, 2018.
Research and development costs reduced $6.4M, or 65%, to $3.4M in the fourth quarter of 2019 versus $9.8M in the previous year quarter. The decrease was primarily driven by lower clinical trial expenses reflecting completion of the clinical phase of the Phase 3 AMPOWER study in November 2018 and of the Phase 2b AMPREVENCE study in August 2019, offset by higher payroll related and consulting service fees.
General and administrative costs increased $4.2M, or 81%, to $9.4M in the fourth quarter of 2019 versus $5.2M in the previous year quarter. This includes a $1.8M increase in pre-commercialization sales and marketing related expenses, reflecting preparations for the potential authorization and launch of Phexxi for the prevention of pregnancy in the second quarter of 2020; a $1.0M increase in payroll related expenses Because of increased headcount; a $1.0M increase in consulting services; and a $0.1M increase in noncash stock-based compensation in the fourth quarter of 2019.
As a result, net loss attributable to ordinary stockholders improved to $12.7M, or $(0.27) per share, for the fourth quarter of 2019 contrast with a net loss of $15.0M, or $(0.58) per share, for the previous year quarter.
The company has 49.62M of outstanding shares and 34.32M shares were floated in the market. According to the most recent quarter its current ratio was 0.9 that represents company’s ability to meet its current financial obligations. The price moved ahead of -0.81% from the mean of 20 days, 2.72% from mean of 50 days SMA and performed -4.35% from mean of 200 days price. Company’s performance for the week was -1.91%, -4.99% for month and YTD performance remained -16.69%.