By Ernest Dela Aglanu, Benzinga
Princeton, NJ –News Direct– Agile Therapeutics, Inc.
From Evofem Biosciences Inc.’s (OTCMKTS: EVFM) Phexxi vaginal gel contraceptive to Dare Bioscience Inc.’s (NASDAQ: DARE) Ovaprene, an investigational hormone-free monthly intravaginal contraceptive, the market isn’t in brief supply of contraception products.
While the difficulty of contraception and abortion will be embroiled in continuous debates and controversies, contraceptives have been known to scale back the speed of unintended pregnancies, the necessity for unsafe abortions, and HIV transmissions from moms to newborns.
The necessity is robust – a 2020 report by the World Health Organization (WHO) said that amongst 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 girls with unmet contraceptive drugs and device needs could present unique opportunities for industry players. Agile Therapeutics Inc.’s (NASDAQ: AGRX) Twirla® (levonorgestrel and ethinyl estradiol) transdermal system could possibly be one progressive product with the potential to disrupt the industry.
Latest Jersey-based Agile Therapeutics is a forward-thinking women’s healthcare company dedicated to fulfilling the unmet needs of today’s women. The corporate’s product and product candidates are designed to supply women more freedom and suppleness through additional contraceptive options.
Agile Therapeutics Chairman and CEO Al Altomari, speaking on the H.C. Wainwright twenty fourth Annual Global Investment Conference in September, revealed that the corporate is currently focused on the expansion of its first Food and Drug Administration (FDA)-approved product Twirla®.
Twirla®, the corporate reports, is the primary and only contraception patch delivering a low dose of estrogen. Twirla delivers 30 micrograms (mcg) of estrogen every day, the bottom exposure of estrogen in a transdermal contraceptive option.
Unlike most oral contraceptives in the marketplace that girls take not less than 21 days every month, Twirla® uses just three patches a month.
Agile Therapeutics plans to commercialize and upscale Twirla through its marketing strategy — non-retail channel growth driver (Afaxys GPO) and retail channel growth drivers (telemedicine providers like Nurx & Twirla’s DTC CTV business).
With the expansion of Twirla® being the primary focus, the corporate believes that constructing a U.S. women’s health franchise on the muse of the patch’s business success can enhance value for shareholders.
“Now we have sought out and can proceed to explore partnerships and opportunities that leverage our existing infrastructure, including co-promotion and business development opportunities,” Altomari said.
Money On Hand And The Way Forward
Agile Therapeutics raised net proceeds of roughly $12.2 million through its at-the-market (ATM) offering within the second quarter of 2022 and $22.2 million in an upsized public offering in July 2022.
The corporate reduced the outstanding principal amount owed to Perceptive Advisors to $3 million with proceeds from ATM.
Agile Therapeutics established a latest $75 million ATM in August 2022.
From the top of the fourth quarter to the top of the second quarter of 2022, the corporate reduced its quarterly operating expenses (OPEX) from $18.2 million to $11.3 million while still growing Twirla demand by 27%.
The corporate now believes it has sufficient money available to fund operations through the top of 2022.
Within the second quarter of 2022, Agile Therapeutics realized net product sales revenue of $2.1 million, a rise of 75% in comparison with 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 related to the Afaxys partnership are expected to significantly speed up within the second half of 2022. Non-retail channels experience higher gross-to-net discounting in comparison with retail channels and subsequently the corporate expects overall gross-to-net discounts to extend as a percentage of gross revenue.
Agile Therapeutics intends to make use of its resources to proceed to grow Twirla® and to enhance on its performance because it prepares to report third-quarter 2022 financial results and Twirla® growth update in November. One among the Company’s financial goals is to develop into money flow positive.
“Our focus in 2022 has been on growing Twirla and advancing towards generating positive money flow,” said Agile Therapeutics Chairman and Chief Executive Officer Al Altomari. “In 2022, now we have significantly reduced our operating expenses by redesigning how we work to realize efficiencies and implemented a plan we imagine can drive Twirla growth through our Afaxys partnership, connected TV (CTV) campaign, and growing the telemedicine channel.”
Agile Therapeutics is a women’s healthcare company dedicated to fulfilling the unmet health needs of today’s women. Our product and product candidates are designed to offer women with contraceptive options that supply freedom from taking a every day pill, without committing to a longer-acting method. Our initial product, Twirla®, (levonorgestrel and ethinyl estradiol), a transdermal system, is a non-daily prescription contraceptive. Twirla is predicated on our proprietary transdermal patch technology, called Skinfusion®, which is designed to permit drug delivery through the skin.
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Matt Riley – Head of Investor Relations & Corporate Communications
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