Evofem Biosciences

Description

Evofem is a US-based biotechnology company which is focused on the development and commercialisation of consumer products for women’s reproductive and sexual health. Its main asset – Amphora – is a non-hormonal, on-demand, woman-controlled contraceptive gel.

We first invested in Evofem in November 2015, when it was still a private business. In October 2017, Evofem agreed a merger with Neothetics which was a reverse takeover that resulted in the company listing on Nasdaq in January 2018. This deal created a strong platform for the future development of Evofem’s pipeline and represented a significant step forward in the company’s journey towards commercialisation.

Investment case summary

The company announced positive top-line results from a Phase III trial in its main asset, Amphora, in December 2018. The Ampower trial, which assessed the efficacy and safety of Amphora,  in approximately 1,400 healthy women, met its primary endpoint with an 86% efficacy rate in typical use. These results pave the way for a new drug application with the US Food & Drug Administration (FDA) in Q2 2019, ahead of commercialisation in 2020.

We are excited about the commercial opportunity that lies ahead for Amphora. There is a large addressable market of women who are not using a contraceptive method but do not want to get pregnant, including women who cannot or will not use hormonal birth control methods. Furthermore, an additional Phase II study continues to look at Amphora’s efficiency in treating sexually transmitted infections.

Ask a question about our investment in Evofem Biosciences

Fund exposure
Equity Income Fund 0.40%
Patient Capital Trust 0.39%

As at 30 November 2018

Segmentation
Geography United States
Industry Health Care
Themes Healthcare innovation

Source: Woodford

Commentary

Positive trial results

Evofem has today announced positive top-line results from a Phase III trial in its main asset, Amphora. The Ampower trial, which assessed the efficacy and safety of Amphora, in approximately 1,400 healthy women, met its primary endpoint with an 86% efficacy rate in typical use. Even more impressively, when used perfectly, as prescribed by the trial protocol, the efficacy rate is 98.7%. Meanwhile, Amphora continues to demonstrate an excellent safety profile.

These results pave the way for a new drug application with the FDA (the US healthcare regulator) in Q2 2019, ahead of commercialisation in 2020. We are excited about the commercial opportunity that lies ahead for Amphora. There is a large addressable market of women who are not using a contraceptive method but do not want to get pregnant, including women who cannot or will not use hormonal birth control methods. Furthermore, an additional Phase II study continues to look at Amphora’s efficiency in preventing sexually transmitted infections.

Saku Saha
17 December 2018

Fundraising

Today Evofem announced a funding round, raising nearly $40m. The company intends to use the proceeds to primarily fund the ongoing trials of Amphora – a phase III study for the prevention of pregnancy and a phase II for the prevention of sexually transmitted infections. We participated in the funding round, adding to the Woodford Equity Income Fund’s position in Evofem as we await the readout from it phase III study in early 2019.

Lucinda Crabtree
22 May 2018

Woodford Investment Management Ltd is authorised and regulated by the Financial Conduct Authority (firm reference number 745433). Incorporated in England and Wales, company number 10118169. Registered address 9400 Garsington Road, Oxford OX4 2HN.

Woodford Patient Capital Trust plc is incorporated in England and Wales, company number 09405653. Registered as an investment company under section 833 of the Companies Act 2006. Registered address Beaufort House, 51 New North Road, Exeter, EX4 4EP.

The Woodford Funds (Ireland) ICAV (the “Fund”) has appointed as Swiss Representative Oligo Swiss Fund Services SA, Av. Villamont 17, 1005 Lausanne, Switzerland. The Fund’s Swiss paying agent is Neue Helvetische Bank AG. All fund documentation including, Prospectus, Key Investor Information Documents, Instrument of Incorporation and financial reports may be obtained free of charge from the Swiss Representative in Lausanne. The place of performance and jurisdiction for all shares distributed in or from Switzerland is at the registered office of the Swiss Representative. Fund prices can be found at www.fundinfo.com.

© 2019 Woodford Investment Management Ltd.
All rights reserved.

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