FC2 Female Condom

Dual protection against unintended pregnancy and transmission of sexually transmitted infections and HIV/AIDs

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Product

The FC2 Female Condom (FC2) is the only FDA-approved single use internal condom for the prevention of pregnancy, sexually transmitted infections (STIs), and HIV/AIDs. It comes prelubricated and is also the only non-hormonal, latex free contraceptive option available to women that can be used on its own or in conjunction with most other forms of contraception providing “layering” benefits.

It is easy to use and covered by most insurance companies with zero out-of-pocket costs due to the Affordable Care Act.

FC2 offers several benefits over natural rubber latex, the raw material most used in male condoms. FC2’s nitrile polymer is stronger than latex, reducing the probability that the female condom sheath will tear during use. Unlike latex, FC2’s nitrile polymer quickly transfers heat. FC2 can warm to body temperature immediately upon insertion, which may enhance the user’s sensation and pleasure. Unlike the male condom, FC2 may be inserted before sex, eliminating disruption during sexual intimacy. FC2 is also an alternative to latex sensitive users who are unable to use condoms without irritation. The non-latex segment of the global condom market is estimated to grow quicker than the latex segment through 2030 at a cumulative annual growth rate of 10%.

FC2 is manufactured from a nitrile polymer formulation and consists of a soft, loose-fitting sheath and two rings: an external ring of rolled nitrile and a loose internal ring made of flexible polyurethane. FC2’s soft sheath lines the vagina, preventing skin-to-skin contact during intercourse. Its external ring remains outside the vagina, partially covering the external genitalia. The internal ring is used for insertion and helps keep the device in place during use.

In the U.S., FC2 is available by prescription through telemedicine and internet pharmacy channels as well as retail pharmacies. The Company has launched its own dedicated direct to patient telemedicine and pharmacy services portal/platform to continue to drive sales growth. FC2 is also available to public health sector entities such as state departments of health and 501(c)(3) organizations.

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U.S. Market

There are approximately 54 million women between the ages of 18-49 who represent the target market due to FC2 being dually indicated for the prevention of pregnancy and/or STIs and HIV/AIDS. According to the CDC, data suggests that STIs in U.S. continued to increase in 2021 – an all-time high for the 6th straight year increasing from 2.4 million to 2.5 million.

FC2 is the only FDA approved for market female use product that protects against unintended pregnancies, the transmission of STIs and HIV/AIDs.

We have established our own dedicated direct to patient digital telemedicine platform to bring our much-needed FC2 product to patients in a cost-effective and highly convenient manner. We remain focused on growing FC2 sales and revenues from our dedicated telemedicine solution while leveraging opportunities that help couples better understand how FC2 can help them take control of their sexual and reproductive health.

FC2 is currently reimbursable by prescription under the Affordable Care Act (ACA). The ACA guidance requires health plans to cover at 100% payment of at least one form of contraception within each of the 16 different categories identified by the FDA in its current Birth Control Guide in which FC2 is in a standalone category of its own. As FC2 is nonhormonal, it is a viable alternative for many U.S. women who have reported dissatisfaction with the side effects of hormonal birth control or are seeking the layering (i.e. STI prevention) benefits FC2 offers since it can be used with many other forms of contraception.

We have built the infrastructure to allow for broad access across the U.S. As a result, FC2 is now available through multiple access channels including: 95% of major retail pharmacies, community-based organizations, by prescription, universities, direct purchase and 340B qualified health care clinics, and directly to the public health sector without distributors. Additionally, we are executing digital and social marketing strategies intended to drive brand interest, awareness, and education; address misconceptions about the brand; and ultimately, help ensure women know they can easily access FC2 and that it is fully reimbursable.

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Global Public Health Sector Market

In the global public sector, FC2 has been cleared by the World Health Organization (WHO) for purchase by U.N. agencies because it is a multipurpose prevention technology by preventing unintended pregnancy and the transmission of STIs, while protecting against HIV/AIDs.

The Company markets FC2 to entities, including ministries of health, government health agencies, U.N. agencies, nonprofit organizations, and commercial partners, that work to support and improve the lives, health and well-being of women around the world since various governments and organizations supply critical products such as FC2, at no cost or low cost, to those who need but cannot afford to buy such products for themselves.

The Company has sold more than 750 million female condoms worldwide and FC2 has been distributed in the U.S. and 149 other countries. A significant number of countries with the highest demand potential are in the developing world. The incidence of HIV/AIDS, other STIs, and unintended pregnancy in these countries represents a remarkable potential for significant sales of a product that benefits some of the world’s most underprivileged people.