Evofem Biosciences, Inc. · OTC:EVFM
Evofem Biosciences — Investor Presentation (January 2019)
18 slides from Evofem Biosciences's investor presentation, Jan 7, 2019
Slide 1: Revolutionizing Women's Sexual and Reproductive Health
Exhibit 99.1 Investor Presentation January 2019 Revolutionizing Women’s Sexual and Reproductive Health
Slide 2: Disclaimer
Disclaimer This presentation contains forward looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws. In some cases, you can identify forward looking statements by terms such as “may,” ”will,” “should,” “expect,” “plan,” “aim,”
Slide 3: Evofem Biosciences at a Glance
Evofem Biosciences at a Glance A Clinical Stage Biopharmaceutical Company committed to developing and commercializing innovative products to address unmet needs in women’s sexual and reproductive health ® Multipurpose Vaginal pH Regulator™ Core focus: developing Amphora , our lead MVP-R product, for
Slide 4: Evofem Successfully Completes the AMPOWER Non-hormonal Contraceptive Trial
Evofem Successfully Completes the AMPOWER Non-hormonal Contraceptive Trial Prespecified efficacy threshold agreed upon with the FDA – point estimate for seven-cycle cumulative pregnancy rate was 16.5% with an upper limit confidence interval of 21% AMPOWER Contraceptive Trial Design Study designed in
Slide 5: Evofem Met Primary Endpoint
Evofem Met Primary Endpoint Typical Use1 (n = 1181) Number of Subjects at Risk of Pregnancy at the Time of Enrollment 1113 Number of Pregnancies 100 Seven-Cycle Cumulative Pregnancy Probability 14.0% 95% CI for Seven-Cycle Pregnancy Probability (10.0%, 18.0%) Perfect Use (per protocol)1 (n = 1103) N
Slide 6: Additional AMPOWER Findings
Additional AMPOWER Findings 1 2 3 There were no serious treatment- Amphora was used in >24,000 acts Based on research conducted emergent adverse events of intercourse. Of these, Amphora among 188 of the subjects who and Amphora was well tolerated1 was used as directed 88.9% of the completed AMPOWER
Slide 7: Anticipated FDA Approval Q4 2019
Anticipated FDA Approval Q4 2019 Q4’18 Q1’19 Q2’19 Q3’19 Q4’19 Q1’20 November 2018 Last Patient Out December 2018 Topline Data January 2019 Database Lock NDA Submission Prep Q2 2019 Anticipated NDA Submission FDA Review Q4 2019 Anticipated FDA Approval January 2020 Commercial Launch ©2019 Evofem Bio
Slide 8: The Time Is Right for Amphora
The Time Is Right for Amphora 77% of women strongly agreed that hormonal contraceptives have a lot of side effects1 “I liked how I could use Amphora whenever I needed to and not everyday. I don’t like adding hormones to my body.” “I am very satisfied and hope I can find it in the market.” AMPOWER Wo
Slide 9: 16.5M Women Say They do not Want to Get Pregnant, but are Doing Nothing
16.5M Women Say They do not Want to Get Pregnant, but are Doing Nothing to Prevent it from Happening1 Millennials: A healthier lifestyle that doesn’t include hormones in their food, makeup, or birth control Non-hormonal Transition: Concerned about side-effects, long-term impact on health, and abilit
Slide 10: Strong Commercial Opportunity for Amphora
Strong Commercial Opportunity for Amphora Prevention Contraception of Chlamydia $965M U.S. Target 1.7M New Cases Contraception 43M Women1 Population in 20172 Using no/non Rx Birth 25M $1.23B Control Using Rx Birth ~18M $268M Control STI Amphora Peak U.S. $965M $268M Revenues Amphora is expected to g
Slide 11: Sales and Marketing Strategy Designed to Maximize Amphora Adoption
Sales and Marketing Strategy Designed to Maximize Amphora Adoption Sales Force Structure • ~10 Regional Manager • ~90 Representatives • 96% coverage of top prescribers of contraception Direct-to-Consumer Advertising • 6-9 months post launch with online videos, digital banners, search, social media,
Slide 12: 1024 HCPs Anticipate Amphora will be the 2nd Highest Form of Birth Control Prescribed
1024 HCPs Anticipate Amphora will be the 2nd Highest Form of Birth Control Prescribed to Women1 HCP Allocation of Primary Birth Control Method Following Amphora Approval (%) Total (n-1024) % %Δ Oral Contraceptives (Regular, 28-day) 26% -14% Amphora 15% Hormonal IUD 11% -10% Condom 8% -20% Injectable
Slide 13: Amphora Highlights
Amphora Highlights Women are more empowered than any other time in history to take control of their reproductive health and well-being Non-hormonal Amphora presents a significant opportunity for women who are concerned about exposure to synthetic hormones Amphora successfully meets its primary endpo
Slide 14: MVP-R Gel Label Expansion Opportunity: Amphora for the Prevention of Chlamydia
MVP-R Gel Label Expansion Opportunity Amphora for the Prevention of Chlamydia 1 Prevention of Chlamydia 1.7M 1Annually Indication1.7M new cases of chlamydia in 2017 inAddressable U.S. Population AMPREVENCE Phase 2b Clinical Trial 2019 2020 2021 2022 Double-blinded, placebo-controlled efficacy trial
Slide 15: Evofem: Right Time…Right Product…Right Team
Evofem: Right Time…Right Product…Right Team Amphora is positioned to be the most substantial birth control innovation in nearly 20 years Projected peak sales potential of ~$3.7B IP through 2033* Strong team continues to successfully execute and deliver results in the face of adversity Proven leaders
Slide 16: Appendix
Appendix
Slide 17: Amphora will Impact Women's Reproductive Health Worldwide with Projected Peak Sales Potential
Amphora will Impact Women’s Reproductive Health Worldwide with Projected Peak Sales Potential of ~$3.7B $1.1B $1.2B $1.4B Western Europe, Eastern U.S. Peak Sales* Asia Pacific Peak Sales* Europe, and the CIS Peak Sales* 43M1 800M2 109M3 Addressable Population Addressable Population Addressable Popul
Slide 18: Evofem IP / Market Exclusivity
Evofem IP / Market Exclusivity Regulatory Competitive Patent Exclusivity Barriers to Entry Exclusive worldwide license to a portfolio of licensed patents held by Currently no established Rush University pathways for demonstrating 3 year exclusivity following bioequivalence of a generic Solely own se
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