N A S D A Q : E V F M

Transcription

1 N A S D A Q : E V F M Jefferies Global Healthcare Conference June 7, 2018

2 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, anticipate, strategy, designed, suggest, currently, could, intend, target, project, contemplate, believe, estimate, predict, potential or continue or the negative of these terms or other similar expressions. The forward looking statements of this presentation are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation risks and uncertainties relating to: the outcome or success of Evofem s clinical trials; Evofem s ability to obtain the necessary regulatory approvals for its product candidates, including approval from the U.S. Food and Drug Administration for the use of Amphora as a contraceptive, and the timing of such approvals; the rate and degree of market acceptance of Amphora ; Evofem s ability to successfully commercialize Amphora and its ability to develop sales and marketing capabilities; Evofem s ability to maintain and protect its intellectual property; Evofem s ability to raise additional capital when needed and to rely on existing cash reserves to fund its current development plans and operations; Evofem s reliance on third party providers, such as third party manufacturers and clinical research organizations; the absence of any adverse events or side effects relating to the use of Amphora ; Evofem s ability to retain members of its management and other key personnel; and other risk factors detailed in Evofem s filings from time to time with the U.S. Securities and Exchange Commission. The forward looking statements in this presentation represent Evofem s views only as of the date of this presentation, June 7, 2018, and Evofem undertakes no obligation to update or review any forward looking statement, whether as a result of new information, future developments or otherwise, except as required by law. 2

3 Our Mission Evofem Biosciences is developing innovative products to fulfil unmet needs of women in reproductive and sexual health. 3

4 Sexually Active Women Doing Nothing Have 85% Risk of Pregnancy within 12 Months Of the 43M women at risk of pregnancy, 16.5M women say they don t want to get pregnant but are doing NOTHING. An additional 2M women use withdrawal and 1M women use the rhythm method. Source: NHS Data Brief #173, December 2014, Current Contraceptive Status Among Women Aged (Based on National Survey of Family Growth data) 4

5 Many Women Will Use Amphora in Addition to Their Current Method Many contracepting women have indicated they would use Amphora for added insurance against pregnancy as well as its lubricative properties Amphora has 510k clearance as a lubricant and is safe to use with any other contraception, hormonal or OTC (i.e. condoms) Research indicates that Amphora provides added confidence in their contraceptive choice when utilized as a supplement to their current method 1 $5.5B U.S. prescription contraceptive sales 2 1. Data source: Company-conducted market research 2. Note: This information is an estimate derived from the use of information under license from the following IMS Health information service: SMART Solutions for the period. IMS expressly reserves all rights, including rights of copying, distribution and republication. 5

6 Market Research Supports Significant Opportunity for Amphora Supplementers (28% of respondents) Highly engaged in their own healthcare Need to protect against unintended pregnancy Alternatives (30% of respondents) Desire non-hormonal contraception as driver to change 100% 90% 80% 70% 60% 50% 28% 30% 71% of women have concerns about hormone exposure 1 Currently Satisfied (42% of respondents) Satisfied with current prescription contraceptive 40% 30% 20% 42% 10% 0% 1. Data source: Company-conducted market research 6

7 About Evofem NASDAQ-listed: EVFM Lead product: Amphora, an on-demand, non-hormonal contraceptive Phase 3 data expected Q Potential U.S. launch Q U.S. Rx contraceptive market valued at $5.5B 1 Additional opportunities in prevention of Chlamydia Gonorrhea Bacterial vaginosis Substantial IP, regulatory and other barriers to competitive entry 1. Note: This information is an estimate derived from the use of information under license from the following IMS Health information service: SMART Solutions for the period. IMS expressly reserves all rights, including rights of copying, distribution and republication. 7

8 Pipeline Targeting Unmet Needs in WHC Phase 1 Phase 2b Phase 3 Target population (U.S.) Amphora Contraception 43M women 1 Prevention of Chlamydia a Prevention of Gonorrhea* 1.6M new cases in ,000 new cases in Antimicrobial Multi-purpose Prevention Technology Vaginal Gel 3 Recurrent Bacterial Vaginosis* 5 21M women 4 a FDA granted Fast Track designation * FDA designated as Qualified Infectious Disease Product (QIDP) 1. Guttmacher Institute. Contraceptive Use in the United States. Available at: Accessed 01 April CDC 2016 Sexually Transmitted Disease Surveillance Report. 3. Multipurpose prevention technologies (MPTs) have a combination of contraceptive, microbicidal and/or anti-sexually transmitted infection (STI) properties \ to prevent pregnancy, HIV and/or STIs. 4. The Prevalence of Bacterial Vaginosis in the United States, ; Associations With Symptoms, Sexual Behaviors, and Reproductive Health. 5. While we have received a QIDP designation, we may be required to reapply should we alter the formulation of this product candidate. 8

9 Seasoned Management Team with Established Track Record of Clinical and Commercial Execution Officer / Title Selected Achievements Saundra Pelletier Chief Executive Officer & President Jay File Chief Financial Officer Kelly Culwell, M.D. Chief Medical Officer Russ Barrans Chief Commercial Officer Extensive global experience as a pharmaceutical executive, entrepreneur and advocate for women s health Founding CEO of WCG, an internationally recognized non-profit organization ~30 years of experience in executive management in women s health Over $600M in equity and debt offerings in the biotech and biopharma industries Commercial launch of four diagnostic tests in the women s health market in a twoyear period ~25 years of experience in accounting and finance in public and private biotech companies Medical advisor to the International Planned Parenthood Federation Medical Officer with the WHO and board-certified gynecologist and obstetrician ~20 years of experience medical oversight in women s health Managed the launch of over half a dozen brands worldwide including Mirena and Plan B One-Step OTC Oversight of global and domestic product launches in women s health ~25 years of experience marketing world wide product sales and distribution 9

10 The Time is Right for a Contraception Revolution Women represent more than 50% of the population yet there have been few notable innovations in women s reproductive health in over 50 years 10

11 Amphora: Attributes & Mechanism of Action L-lactic acid, citric acid, and potassium bitartrate Acid-buffering properties Maintains acidic vaginal environment, preventing the survival of spermatozoa The introduction of semen into the vagina raises the ph above 6.0 Amphora maintains the natural vaginal ph, inhibiting spermatozoa Highly bioadhesive, forming a layer over vaginal and cervical surfaces ph Levels Acidic Amphora - Normal Vaginal ph Level Body ph Level 5 Water ph Level 7 Semen/Blood ph Level Soap ph Level 7-14 Basic 11

12 Amphora: Multiple Potential Advantages over Current Methods Hormone-free On-demand & woman-controlled Easy to self-administer Bioadhesive No weight restrictions / BMI agnostic Personal lubricant properties Cost effective 12

13 Amphora Poised to Disrupt the WHC Market Product Class Non- Hormonal No Systemic Side Effects Non-invasive Convenient Amphora* 28 Day Oral Contraceptives Extended Regimen Oral Contraceptives Hormone Releasing IUDs Copper IUD Implant Vaginal Ring Transdermal Patch * Investigational product 13

14 Timeline to Market: Amphora Completing confirmatory Phase 3 Trial Single-arm, open label trial in 1,400 women age at 112 U.S. sites 5 gram dose of Amphora administered up to one hour before intercourse Primary endpoint: contraceptive efficacy over seven cycles Exploratory endpoint: sexual satisfaction Top-line results expected Q Enrollment Confirmatory Phase 3 Trial Top Line Results NDA Resubmission Anticipated Approval & Launch 14

15 Strategies for Successful Launch in Q Position Amphora at launch as first and only non-hormonal, on-demand, woman-controlled, prescription contraceptive gel for women who refuse to take hormones 1 New category in contraception: Prescription Contraceptive Gel Sales force of 85 reps and 10 managers can cover 96% of high prescribers in contraception 2 ~12,000 HCP call plan Direct to consumer advertising 6 9 months post-launch No reimbursement challenges or access issues expected for Amphora 1. Data source: Company - conducted market research 2. Based on an IQVIA recommendation 15

16 Amphora Label Expansion Opportunity: Prevention of Chlamydia 1.6M new cases of chlamydia in 2016 in U.S. 1 Phase 2b trial underway Double-blinded, placebo-controlled efficacy trial at up to 50 U.S. sites 844 women, years old, with chlamydia or gonorrhea infection in past four months Four-month interventional period + one-month follow-up Primary endpoint: Prevention of chlamydia trachomatis in women Fast Track designation for prevention of urogenital chlamydia in women 1. CDC 2016 Sexually Transmitted Disease Surveillance Report 16

17 Key Stock Data Ticker NASDAQ: EVFM Shares outstanding (as of 05/24/2018)* 26.3M Common stock warrants outstanding: Merger-related May 2018 offering $8.35 $7.50 Cash and cash equivalents (as of 03/31/2018) Net proceeds from public offering of stock and warrants (05/24/2018) $5.0M $36.4M *Includes shares of common stock and pre-funded warrants exercisable for shares of common stock sold in the May 2018 public offering 17

18 Multiple Near-term Catalysts Initiate Phase 2b Amphora STI trial (first patient in) Dec 2017 FDA grants Fast Track designation to Amphora for the prevention of urogenital chlamydia in women Feb 2018 Complete enrollment in Phase 3 Amphora contraceptive trial Feb 2018 Top-line results from Phase 3 Amphora contraceptive trial Q Resubmit Amphora NDA for contraception Q Anticipated FDA action on Amphora NDA for contraception Q Launch Amphora for contraception Q

19 Evofem Biosciences It s time for women to have a non-hormonal contraceptive product with no systemic side-effects It s time women were empowered with a contraceptive product they control and use on demand It s time that women should be the subjects of pleasure, versus the objects It s time for a product that prevents chlamydia and gonorrhea It s time for a new innovation in women s health 19

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