AGRX - Can This Company’s Birth Control Patch Disrupt The Contraceptive Market?
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From EvofemBiosciences Inc. ’s (OTCMKTS: EVFM) Phexxi vaginal gelcontraceptive to Dare Bioscience Inc. ’s (NASDAQ: DARE)Ovaprene, an investigational hormone-free monthly intravaginalcontraceptive, the market is never in short supply of birth controlproducts.
Whilethe issue of birth control and abortion can be embroiled in continuousdebates and controversies ,contraceptives have been knownto reduce the rate of unintended pregnancies, the need forunsafe abortions, and HIV transmissions from mothers tonewborns.
The needis strong - a 2020 report by the World Health Organization (WHO) said that among 1.9 billionreproductive-age women (15 to 49 years) globally in 2019, around 1.1billion women require family planning and 270 million of those have anunmet need for contraception.
Disruptive ContraceptivePatch?
Therising number of women with unmet contraceptive drugs and device needscould present unique opportunities for industry players. AgileTherapeutics Inc. ’s (NASDAQ: AGRX) Twirla® (levonorgestrel and ethinyl estradiol) transdermal system could be oneinnovative product with the potential to disrupt the industry.
New Jersey-based Agile Therapeutics isa forward-thinking women’s healthcare company dedicated tofulfilling the unmet needs of today’s women. The company’s productand product candidates are designed to offer women more freedom andflexibility through additional contraceptive options.
Agile TherapeuticsChairman and CEO Al Altomari, speaking at the H.C.Wainwright 24th Annual Global Investment Conference inSeptember, revealed that the company is currently focused on thegrowth of its first Food and Drug Administration (FDA)-approvedproduct Twirla®.
Twirla®, the company reports, is the first and only birthcontrol patch delivering a low dose of estrogen. Twirla delivers 30micrograms (mcg) of estrogen daily, the lowest exposure of estrogen ina transdermal contraceptive option.
Unlike most oral contraceptives on the market thatwomen take at least 21 days each month, Twirla® uses just threepatches a month.
Agile Therapeutics plans to commercialize and upscale Twirlathrough its business plan — non-retail channel growth driver ( Afaxys GPO ) and retailchannel growth drivers (telemedicine providers like Nurx & ).
With the growth of Twirla® being the main focus, the companybelieves that building a U.S. women’s health franchise on thefoundation of the patch’s commercial success can enhance value forshareholders.
“We have sought out and will continue to explore partnershipsand opportunities that leverage our existing infrastructure, includingco-promotion and business development opportunities,” Altomarisaid.
Cash On Hand And The Way Forward
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Agile Therapeutics raised net proceeds of approximately $12.2million through its at-the-market (ATM) offering in the second quarterof 2022 and $22.2 million in an upsized public offering in July 2022.
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The company reduced theoutstanding principal amount owed to Perceptive Advisors to $3 millionwith proceeds from ATM.
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Agile Therapeutics established a new $75 million ATM in August2022.
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From the end of thefourth quarter to the end of the second quarter of 2022, the companyreduced its quarterly operating expenses (OPEX) from $18.2 million to$11.3 million while still growing Twirla demand by 27%.
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The company now believesit has sufficient cash on hand to fund operations through the end of2022.
Inthe second quarter of 2022, Agile Therapeutics realized net productsales revenue of $2.1 million, an increase of 75% compared to thesecond quarter of 2021 revenue of $1.2 million. Total operatingexpenses for the second quarter of 2022 were $11.3 million.
Non-retail salesprimarily associated with the Afaxys partnership are expected tosignificantly accelerate in the second half of 2022. Non-retailchannels experience higher gross-to-net discounting compared to retailchannels and therefore the company expects overall gross-to-netdiscounts to increase as a percentage of gross revenue.
Agile Therapeuticsintends to use its resources to continue to grow Twirla® and toimprove on its performance as it prepares to report third-quarter 2022financial results and Twirla® growth update in November. One of theCompany’s financial goals is to become cash flow positive.
“Our focus in 2022 hasbeen on growing Twirla and advancing towards generating positive cashflow,” said Agile Therapeutics Chairman and Chief Executive OfficerAl Altomari. “In 2022, we have significantly reduced our operatingexpenses by redesigning how we work to gain efficiencies andimplemented a plan we believe can drive Twirla growth through ourAfaxys partnership, connected TV (CTV) campaign, and growing thetelemedicine channel.”
Agile Therapeutics is a women'shealthcare company dedicated to fulfilling the unmet health needs oftoday’s women. Our product and product candidates are designed toprovide women with contraceptive options that offer freedom fromtaking a daily pill, without committing to a longer-acting method. Ourinitial product, Twirla®, (levonorgestrel and ethinyl estradiol), atransdermal system, is a non-daily prescription contraceptive. Twirlais based on our proprietary transdermal patch technology, calledSkinfusion®, which is designed to allow drug delivery through theskin.
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MattRiley - Head of Investor Relations & CorporateCommunications
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