Agile Therapeutics files IPO for Contraceptive Patch

If we are to believe the Nanalyze website data trends, it seems that most of our readers probably have very little knowledge of female contraceptives, other than what their significant others may make mention of occasionally. What should be of interest to any investor regardless of their gender, is that the global contraceptives market is expected to grow at a CAGR of 5.5% from 2012 to 2018, to reach $23.3 billion in 2018. The U.S. hormonal contraceptive market alone had total market sales of $5.6 billion in 2013. One company that wants to enter this space with a unique contraceptive patch offering is Agile Therapeutics.

About Agile Therapeutics

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Founded in 1997, Princeton New Jersey-based Agile Therapeutics has developed a female contraceptive patch which is in Phase 3 clinical development. Since 2010, Agile has taken in around $87 million from Aisling Capital, Care Capital, Investor Growth Capital, ProQuest Investments, Kaiser Permanente Ventures, and Novitas Capital. Agile filed on March 17 with the SEC to raise up to $69 million in an initial public offering. The IPO offering is expected to fund Agile’s operations through the first quarter of 2016. While Agile currently has just 11 full-time employees, they believe they can address the US market with a specialty sales force of approximately 70 to 100 representatives. They also plan to engage in digital marketing and other techniques to market directly to patients.

History of the Contraceptive Patch

Launched in 2002 by Janssen Pharmaceuticals (a pharmaceutical company of J&J), the Ortho Evra® contraceptive patch, was the first and remains the only FDA-approved contraceptive patch. It was the most successful product launch in the history of the U.S. contraceptive market, and the product rapidly gained annual sales levels of nearly $400 million by 2004. However, following the approval of Ortho Evra, users began to report thrombotic side effects to the FDA. A study was conducted in 2005 to compare the contraceptive patch to an oral contraceptive, which showed Ortho Evra delivered higher concentrations of the active ingredient EE compared to an oral contraceptive. In 2005, Janssen changed the product labeling to include information about this exposure. In 2011, the FDA concluded that users of Ortho Evra have an increased risk of developing venous thrombosis but that the benefits of Ortho Evra outweighed the risks. Janssen revised product labeling again in 2012. The Evra market share declined rapidly following the labeling changes, from a peak share of 11% in 2005, to 4% by the end of 2006, to 1.4% by the end of 2013. Even at 1.4% market share, Ortho Evra was still bringing in $150 million in sales last year.

Agile’s Pipeline

Agile’s weekly contraceptive patch, Twirla (AG200-15), contains the active ingredients levonorgestrel (LNG) and ethinyl estradiol (EE), both of which are used in many currently marketed contraceptives. Twirla is in Phase 3 clinical development and Agile anticipates receiving data from their Phase 3 trial by the end of 2015. Agile’s pipeline is as follows:

Agile_Therapeutics_Pipeline

The three other candidates are a) AG200-ER, a regimen designed to allow a woman to extend the length of her cycle b) AG200-SP, a regimen that will provide a shortened hormone-free interval. c) AG890, a P-only prescription contraceptive patch intended for use by women who are unable or unwilling to take estrogen.

Conclusion

According to a report on the contraceptives market by Transparency Market Research, “the global topical contraceptives market is the second fastest growing market after contraceptive pills. Its growth rate is justified by the possible introduction of new products such as AG200-15 by Agile Therapeutics in 2014“. The previous successful introduction of Ortho Evra shows there is a demand for a contraceptive patch and that such a product can rapidly capture market share.  If Agile is able to convince the medical community that they do not have the same problems that Ortho Evro did along with marketing directly to the patient, they could realize the same market share gains as Ortho Evro did in 2004. This could mean going from zero to $560 million in sales in just two years (10% of 2013 revenues for hormonal contraception). Assuming timely completion of Phase 3 trial by 2015 and ultimate FDA approval, Agile expects to make Twirla available by prescription in the United States in the fourth quarter of 2016.

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