From Evofem Biosciences Inc.’s EVFM Phexxi vaginal gel contraceptive to Dare Bioscience Inc.’s DARE Ovaprene, an investigational hormone-free monthly intravaginal contraceptive, the market is never in short supply of birth control products.
While the issue of birth control and abortion can be embroiled in continuous debates and controversies, contraceptives have been known to reduce the rate of unintended pregnancies, the need for unsafe abortions, and HIV transmissions from mothers to newborns.
The need is strong - a 2020 report by the World Health Organization (WHO) said that among 1.9 billion reproductive-age women (15 to 49 years) globally in 2019, around 1.1 billion women require family planning and 270 million of those have an unmet need for contraception.
Disruptive Contraceptive Patch?
The rising number of women with unmet contraceptive drugs and device needs could present unique opportunities for industry players. Agile Therapeutics Inc.’s AGRX Twirla® (levonorgestrel and ethinyl estradiol) transdermal system could be one innovative product with the potential to disrupt the industry.
New Jersey-based Agile Therapeutics is a forward-thinking women’s healthcare company dedicated to fulfilling the unmet needs of today’s women. The company’s product and product candidates are designed to offer women more freedom and flexibility through additional contraceptive options.
Agile Therapeutics Chairman and CEO Al Altomari, speaking at the H.C. Wainwright 24th Annual Global Investment Conference in September, revealed that the company is currently focused on the growth of its first Food and Drug Administration (FDA)-approved product Twirla®.
Twirla®, the company reports, is the first and only birth control patch delivering a low dose of estrogen. Twirla delivers 30 micrograms (mcg) of estrogen daily, the lowest exposure of estrogen in a transdermal contraceptive option.
Unlike most oral contraceptives on the market that women take at least 21 days each month, Twirla® uses just three patches a month.
Agile Therapeutics plans to commercialize and upscale Twirla through its business plan — non-retail channel growth driver (Afaxys GPO) and retail channel growth drivers (telemedicine providers like Nurx & Twirla’s DTC CTV commercial).
With the growth of Twirla® being the main focus, the company believes that building a U.S. women’s health franchise on the foundation of the patch’s commercial success can enhance value for shareholders.
“We have sought out and will continue to explore partnerships and opportunities that leverage our existing infrastructure, including co-promotion and business development opportunities,” Altomari said.
Cash On Hand And The Way Forward
- Agile Therapeutics raised net proceeds of approximately $12.2 million through its at-the-market (ATM) offering in the second quarter of 2022 and $22.2 million in an upsized public offering in July 2022.
- The company reduced the outstanding principal amount owed to Perceptive Advisors to $3 million with proceeds from ATM.
- Agile Therapeutics established a new $75 million ATM in August 2022.
- From the end of the fourth quarter to the end of the second quarter of 2022, the company reduced its quarterly operating expenses (OPEX) from $18.2 million to $11.3 million while still growing Twirla demand by 27%.
- The company now believes it has sufficient cash on hand to fund operations through the end of 2022.
In the second quarter of 2022, Agile Therapeutics realized net product sales revenue of $2.1 million, an increase of 75% compared to the second quarter of 2021 revenue of $1.2 million. Total operating expenses for the second quarter of 2022 were $11.3 million.
Non-retail sales primarily associated with the Afaxys partnership are expected to significantly accelerate in the second half of 2022. Non-retail channels experience higher gross-to-net discounting compared to retail channels and therefore the company expects overall gross-to-net discounts to increase as a percentage of gross revenue.
Agile Therapeutics intends to use its resources to continue to grow Twirla® and to improve on its performance as it prepares to report third-quarter 2022 financial results and Twirla® growth update in November. One of the Company’s financial goals is to become cash flow positive.
“Our focus in 2022 has been on growing Twirla and advancing towards generating positive cash flow,” said Agile Therapeutics Chairman and Chief Executive Officer Al Altomari. “In 2022, we have significantly reduced our operating expenses by redesigning how we work to gain efficiencies and implemented a plan we believe can drive Twirla growth through our Afaxys partnership, connected TV (CTV) campaign, and growing the telemedicine channel.”
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