Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (March 2019)
78 slides from Dare Bioscience's investor presentation, Mar 5, 2019
Slide 1: Delivering innovation by daring to be different
Exhibit 99.1 Delivering innovation by daring to be different 1 March 5, 2019
Slide 2: Forward Looking Statements
THIS PRESENTATION IS FOR INFORMATIONAL PURPOSES ONLY AND IS NOT AN OFFER TO SELL OR A SOLICITATION OF AN OFFER TO BUY ANY SECURITIES OF DARÉ BIOSCIENCE, INC. (“DARÉ” OR THE “COMPANY”). THIS PRESENTATION INCLUDES CERTAIN INFORMATION OBTAINED FROM TRADE AND STATISTICAL SERVICES, THIRD PARTY PUBLICATIO
Slide 3: What We Do
What We Do Vision: To become the coordinating presence in women’s health. Mission: We achieve this by identifying, unlocking and advancing innovation that improves health outcomes and promotes a better quality of life for women. Daring to be different 3
Slide 4: A pure play biopharmaceutical company focused on women's health
Daring to be different A pure play biopharmaceutical company focused on improving the health and well being of women. At Daré, we focus on targeted delivery of products to address persistent unmet needs in women’s health. Our focus areas include: • Pregnancy Prevention • Sexual Health Daré • Vaginal
Slide 5: Coordinating Presence in Women's Health
Coordinating Presence in Women’s Health Market Misalignment = A Value Creation Opportunity Innovators seeking development partners to advance Large and mid-tier companies prefer to acquire or license products products to commercialization in women’s health. that are later-stage or ready for commerci
Slide 6: Product pipeline
Regulatory Pre-Clinical Phase 1 Phase 2 Phase 3 Filing Vaginal Gel ^ Clindamycin DARE-BV1 Formerly MP-101 Phase 3 Initiation 2H 2019 Bacterial Vaginosis Barrier IVR ® CDRH / Device Lead Ferrous gluconate Ovaprene (PCT)* Top line 2H 2019 Non-Hormonal, Monthly Contraception Topical Cream ^ Sildenafil
Slide 7: Portfolio Timeline Overview
Portfolio Timeline Overview 2019 2020 2021 2022 2023 Current Development Status DARE-BV1^ U.S. Potential (Bacterial Vaginosis) Phase 3 Regulatory Review U.S. Launch Ovaprene® Potential U.S. PCT* Pivotal U.S. Regulatory Review (Contraception) Launch CDRH / Device Lead Sildenafil Cream, 3.6%^ Phase 2b
Slide 8: Investment Highlights
Investment Highlights 8
Slide 9: Financial Profile
Financial Profile Background • NASDAQ:DARE • Publicly traded via reverse merger that closed July 19, 2017 Balance sheet, September 30, 2018: • $9.5 million in cash • Non-dilutive NIH SBIR Award: • In Q2-2018, Daré received a Notice of Award for the first $224,665 of an anticipated $1.9 million in gr
Slide 10: Management Team
Management Team Daré Bioscience Sabrina Martucci Johnson, MSc, MIM Cypress Bioscience, Calibr, Advanced Tissue Sciences, WCG, Baxter Healthcare President and CEO Lisa Walters-Hoffert Chief Financial Officer ROTH Capital Partners, Citicorp Securities, Bank of America, Oppenheimer & Co. David Friend,
Slide 11: Board of Directors
Board of Directors Daré Bioscience Roger Hawley (Chairman) Zogenix, Alios Biopharma, Cypress Bioscience, InterMune, Elan Corporation, GSK Jessica Grossman, MD Medicines360, Sense4Baby, Johnson & Johnson Susan Kelley, MD Bayer, BMS, ArQule,Cerulean Greg Matz CooperSurgical - Cooper Companies, Agilent
Slide 12: Program Overview
Program Overview 12
Slide 13: DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
DARE-BV1 (Formerly MP-101) Clindamycin 2% gel for Bacterial Vaginosis 13
Slide 14: DARE-BV1 Overview
DARE-BV1 Overview Bacterial Vaginosis (BV) Successful Proof of Concept • Vaginal application of DARE-BV1 (clindamycin phosphate 2%) demonstrated effectiveness against BV in a proof-of-concept investigator initiated study in women (n=30):1 • 88% of evaluable subjects met clinical cure endpoint at Tes
Slide 15: Bacterial Vaginosis Symptoms & Causes
Bacterial Vaginosis Symptoms & Causes of BV • BV is the most commonly reported vaginal infection in women ages 15- 44.1 BV is characterized by a shift in the vaginal flora from the dominant Lactobacillus to a polymicrobial flora.2 • BV has been associated with serious health issues, including preter
Slide 16: Bacterial Vaginosis Symptoms & Causes of BV
Bacterial Vaginosis Symptoms & Causes of BV • BV is characterized by the presence of three of the following four 2 criteria: Vaginal pH of >4.5 Clue cells on saline wet mount Release of a fish amine odor A characteristic thin, homogenous vaginal discharge ▪ In 1991, Nugent et al. described a
Slide 17: Bacterial Vaginosis Market Opportunity
Bacterial Vaginosis Market Opportunity • In the US, an estimated 21 million women aged 14-49 years (approximately 29%) are infected with BV.1,2 BV leads to symptoms including abnormal vaginal discharge and odor that are unpleasant and disrupt and interfere with a woman’s relationships and general
Slide 18: DARE-BV1 Proof of Principle Study Design
Bacterial Vaginosis DARE-BV1 (Formerly MP-101) Proof of Principle Study Design Study Objective: Study the Efficacy and Safety of DARE-BV1 in the Treatment of Bacterial Vaginosis Proof of Principle Study Design (n = 30) Day 1 Day 7 - 14 Day 21 - 30 Baseline Visit Test-of-Cure Visit Continued Clinical
Slide 19: DARE-BV1 Proof of Principle Results
Bacterial Vaginosis DARE-BV1 (Formerly MP-101) Proof of Principle Study Design A single dose of DARE-BV1 demonstrated high clinical cure rate compared to other approved products Product Clinical (Amsel) Cure Bacteriologic Therapeutic Cure (Nugent) Cure DARE-BV1 novel gel (clindamycin) 88% 57%* 57%*
Slide 20: Contraception
Contraception Expected to be a $33 billion global category by 20231 20 1. Global Market Insights, https://globenewswire.com/news-release/2016/05/19/841462/0/en/Contraceptives-Market-size-to-exceed-33-Billion-by-2023-Global-Market-Insights-Inc.html
Slide 21: Ovaprene Overview
New Contraceptive Option Ovaprene® Overview Successful Proof of Concept Study • Ovaprene demonstrated effectiveness in preventing sperm from entering the cervical canal in a proof-of-concept study in women (n=20):1 • No viable sperm in the cervical mucus • No colposcopic abnormalities CDRH (Device)
Slide 22: Innovation in Contraception
New Contraceptive Option Ovaprene® Overview Innovation in Contraception Advances in hormone products have largely focused on reducing the hormone dosage, adjusting or extending the duration of protection and optimizing methods of administration. 1 2 3 4 Convenience is driving new innovation • NuvaRi
Slide 23: Women's Preferences
New Contraceptive Option Ovaprene® Overview Women’s Preferences • Effective Pregnancy Prevention • Convenient Product Forms • Independent surveys revealed that the vaginal ring has many of the features women deemed extremely important.1 • Less Hormones • A majority of women prefer a monthly option w
Slide 24: What's Missing in Contraception?
What’s Missing in Contraception? Hormone free alternatives that are effective and easy to use Least Effective Hormone Free Product Landscape1 Marketed or in development Spermicides / Vaginal Gels 1,2 Effectiveness (72% Typical Use) Woman controlled Used “in the moment” Condoms Effectiveness (82% Typ
Slide 25: Ovaprene Non-hormonal, Monthly Vaginal Ring
New Contraceptive Option Ovaprene® Overview Ovaprene® Non-hormonal, Monthly Vaginal Ring Spermiostatic Environment1 • Achieved through a contraceptive-loaded silicone ring matrix. • Releasing non-hormonal active Ferrous gluconate. Physical Barrier1 • 3-D, non-braided, fluid-permeable mesh barrier. R
Slide 26: Ovaprene Previous Postcoital Test Study
New Contraceptive Option Ovaprene® Overview Ovaprene successfully prevented sperm from reaching the cervical canal in a previous human postcoital test (PCT) clinical study. • 2009 - Postcoital Assessment:1 • Open-label, single-arm, pilot safety and tolerability study. 2,3 • Published in the Journal
Slide 27: Ovaprene U.S. Regulatory Strategy
New Contraceptive Option Ovaprene® Overview U.S. Regulatory Strategy • PMA with CDRH (Medical Device Division) as lead review division. • Pathway expected to be based on similar CDRH approvals - Example: Caya® diaphragm.* Step 1 – Postcoital test (PCT) 2018 / 2019* Step 2 – Pivotal Study 2020 / 2021
Slide 28: Ovaprene Features Desired in Birth Control
New Contraceptive Option Ovaprene® Overview Features Desired Most in Birth Control:1-4 Design Features of Ovaprene:5,6 + Convenience Monthly Ring Product Form (Easy to Use & Easy to Remember) Women chose rings for the convenience of a non-daily option. + Hormone Free No Hormones in the API Unique du
Slide 29: Female Sexual Arousal Disorder (FSAD)
Women’s Sexual Health & Wellness Female Sexual Arousal Disorder (FSAD) World market for both male and female sexual dysfunction drugs will reach 7.7 billion in 20191 29 1. https://www.visiongain.com/sexual-dysfunction-drugs-market-will-reach-7-7bn-in-2019-predicts-a-new-visiongain-study/
Slide 30: Sildenafil Cream, 3.6% Overview
Female Sexual Arousal Disorder (FSAD) Sildenafil Cream, 3.6% Successful Proof of Concept • Sildenafil Cream, 3.6% improved genital blood flow in a proof-of-concept study (n=31):1 • Efficacy signal observed in both pre and postmenopausal patients • Excellent systemic/local safety and tolerability pro
Slide 31: FSAD: No Approved Products
Female Sexual Arousal Disorder (FSAD) Sildenafil Cream 3.6% Hypoactive Sexual Female Sexual Vulvar-Vaginal Dyspareunia Desire Disorder Arousal Disorder Atrophy (HSDD) (FSAD) No Approved Products With its approval of Addyi®, FDA has now acknowledged and formally classified the distinct and separate d
Slide 32: FSAD Prevalence
Female Sexual Arousal Disorder (FSAD) Sildenafil Cream 3.6% FSAD is characterized primarily by an inability to attain or maintain sufficient physical sexual arousal; it is also characterized by distress or interpersonal difficulty.* • Estimated 23-33% of women suffer from arousal disorder: • Meta-an
Slide 33: Key Takeaways of Viagra Studies
Key Takeaways of Viagra® studies: • Oral sildenafil (Viagra) demonstrated statistically significant activity Female Sexual Arousal Disorder (FSAD) • Side effects of the oral formulation led to the investigation of a new Sildenafil Cream 3.6% route of administration Increased blood flow and clinical
Slide 34: Formulation Innovation
Female Sexual Arousal Disorder (FSAD) Sildenafil Cream 3.6% Formulation Innovation • Sildenafil Cream, 3.6% designed to directly increase local blood flow to the genital tissue. • The formulation delivers localized action, with minimal systemic uptake of the active drug.1 SST Formulation Technology
Slide 35: Sildenafil Cream Phase 1 and Phase 2a Studies
Female Sexual Arousal Disorder (FSAD) Sildenafil Cream, 3.6% Sildenafil C T AUC Treatment N max max last Phase 1 Study of SST-6007 (Sildenafil Cream, 3.6%)1 Single Dose (ng/ml) (hr) (h*ng/ml) • Normal healthy postmenopausal women were dosed with Topical Sildenafil 20 35 mg 3.4 2.37 25.6 escalating d
Slide 36: Phase 2b Program
Female Sexual Arousal Disorder (FSAD) Sildenafil Cream 3.6% Phase 2b Program: Continue to explore additional clinical and non-clinical work that might be valuable or required to support the overall program and the anticipated design of the Phase 2b. Content Validity Planned Type C Meeting At Home St
Slide 37: FSAD Landscape if Sildenafil Cream Approved
Female Sexual Arousal Disorder (FSAD) Sildenafil Cream 3.6% Hypoactive Sexual Female Sexual Vulvar-Vaginal Dyspareunia Desire Disorder Arousal Disorder Atrophy (HSDD) (FSAD) Sildenafil Cream, 3.6% (If approved) With its approval of Addyi®, FDA has now acknowledged and formally classified the distinc
Slide 38: Innovative Vaginal Drug Delivery
$32 billion global category* Innovative Vaginal Drug Delivery Well characterized therapeutic options 38
Slide 39: Intravaginal Ring (IVR) Technology Platform
Intravaginal Ring (IVR) Technology Platform Daré has an exclusive, global license to Juniper’s novel IVR technology originally developed by Dr. Robert Langer from MIT1 and Dr. William Crowley2 from Massachusetts General Hospital and Harvard Medical School. Daré’s exclusive license covers all ring
Slide 40: Hormone Replacement Therapy DARE-HRT1
Hormone Replacement Therapy (HRT) DARE-HRT1 HRT remains the most effective treatment for vasomotor symptoms 4 (VMS) and the genitourinary syndrome of menopause (GSM) and has $2.2 Billion U.S. Market been shown to prevent bone loss and fracture.1 • 45M women in U.S. approaching or in menopause.2 • 20
Slide 41: DARE-HRT1 Phase 1 Study
Hormone Replacement Therapy (HRT) DARE-HRT1 Phase 1 - Hormone Replacement Therapy (HRT) DARE-HRT1 for the treatment of VMS due to menopause – combination bio-identical estradiol and progesterone in a convenient 28 day IVR • Proposed Study: • A Phase 1, Open-Label, 3-arm Parallel Group Study to Evalu
Slide 42: Vaginally Delivered Tamoxifen for VVA
Vaginally Delivered Tamoxifen for VVA DARE-VVA1 Vaginally Delivered Tamoxifen to treat VVA in HR+ Breast Cancer Patients • DARE-VVA1 (Formerly PT-101) • A proprietary vaginal formulation of tamoxifen, has the potential to be a first-in-class treatment for vulvar and vaginal atrophy (VVA) in patients
Slide 43: Strategic Pre-Clinical Candidates
$32 billion global category* Strategic Pre-Clinical Candidates Contraceptives that address global gaps 43
Slide 44: Daré's Innovation Engine
"Innovative partnerships increase access to family planning, helping more women plan their lives and shape their futures.” Chris Elias, President Global Development Program, Bill & Melinda Gates Foundation Dare’s Major foundations contribute hundreds of Innovation millions of dollars to fund new inn
Slide 45: Value Creation in Women's Reproductive Health
License Funding Product Annual Sales / Organization Holder / Form Indication Source / Donor Name Corporate Value Partner 2018 Annovera USAID Therapeutics Ring Pregnancy $20M upon FDA MD Gates Prevention approval; Foundation $20M first commercial batch, milestones + Value Creation royalties1 in Women
Slide 46: A New Contraceptive Target DARE-RH1 CatSper
A New Contraceptive Target DARE-RH1 CatSper A Novel Approach To Male And Female Contraception. • The identification of the CatSper target represents the potential to develop a novel class of non-hormonal contraceptive products for both men and women. • The discovery of a sperm-specific ion channel,
Slide 47: A New Long Acting Contraceptive Option
A New Long Acting Contraceptive Option Microparticle 6 & 12 Month Injectable Contraception ORB-204 and ORB-214, injectable etonogestrel1 The initial development on Orbis’ long-acting injectable contraceptive program was carried out under a subcontract funded by Family Health International (FHI 360)
Slide 48: Corporate & Investor Communications
Corporate & Investor Communications NASDAQ: DARE Trading as DARE since July 20, 2017 www.darebioscience.com 48
Slide 49: Appendix: Consumer & Market Insights
Appendix Daré Programs: Consumer & Market Insights
Slide 50: Bacterial Vaginosis Market Insights
Bacterial Vaginosis Market Insights American Sexual Health Association (ASHA), in conjunction with Harris Poll, conducted a national survey of 304 women ages 18 to 49 who have had bacterial vaginosis (BV). The survey was conducted online by Harris Poll on behalf of Symbiomix Therapeutics, LLC, a Lup
Slide 51: ASHA National Bacterial Vaginosis Survey
Bacterial Vaginosis Market Insights American Sexual Health Association (ASHA) National Bacterial Vaginosis Survey IF BV RISK FACTORS WERE KNOWN • 76% of women with BV stated they would have gone to see a healthcare professional sooner if they were Would Seek Treatment Sooner aware of the risks assoc
Slide 52: Impact of BV on Daily Life
Bacterial Vaginosis Market Insights American Sexual Health Association (ASHA) National Bacterial Vaginosis Survey • According to the ASHA IMPACT OF BV ON DAILY LIFE survey, 62% of women 90 mistake BV for a yeast infection prior to diagnosis 80 • Most women with BV feel 70 self-conscious (68%) and/or
Slide 53: Ovaprene Market Insights
Ovaprene Market Insights Secondary Market Research & Market Sizing Data Prepared by SmartPharma, February 2019. Data on File.
Slide 54: US Contraceptive Population
US Contraceptive Population is Over 60 million and Continues to Grow Total US Females Age 15-44 (Millions) 69 68 68.0 68.1 68.1 67.8 67.6 67.5 67 67.3 67.2 67.0 66.8 66.7 66.5 66 44 (MM) 44 - 66.2 65.8 65 65.4 65.0 64.6 Females age 15 age Females 64 64.2 63.9 63.6 63 62 2016 2017 2018 2019 2020 2021
Slide 55: Ovaprene Potential Total Market Size
Ovaprene Potential – Total Market Size There are currently 35 million US women who could potentially choose Ovaprene for contraception 65 Million Total US Women Age 15-44 30 Million Not candidates for Ovaprene • Sterilization (10.5M) 12 Million 11 Million 12 Million • Pregnant/postpartum/ Current No
Slide 56: Negative Information About Hormones
Negative Information About Hormones is Persistent in the Public Domain As a non-hormonal option, Ovaprene does not have to overcome myths or negative “press” Reason #1: “I don’t want to get fat” Reason #2: “It might make me depressed” • The pill lowers your sex drive • The pill shrinks your clitoris
Slide 57: Contraceptive Pricing and Reimbursement
Contraceptive Pricing and Reimbursement Dare Bioscience – Ovaprene Market Assessment, Jan 2019 57
Slide 58: Brand Contraceptives Have Consistently Increased in Price
Brand Contraceptives Have Consistently Increased in Price Average Price/Cycle (28 days) for Branded CHCs ($WAC) – As of Jan 2019 $170.00 $160.47 $160.00 $152.50 $150.00 $140.03 $140.00 $129.51 $130.00 $115.40 $120.00 $110.00 $100.64 $100.00 $88.88 $90.00 $81.95 $76.41 $80.00 $68.02 $70.00 $58.94 $60
Slide 59: Over 70% of Reproductive-Aged Women Have Private Insurance
Over 70% of Reproductive-Aged Women in the US Have Private Insurance Trend in Insurance Coverage Over Time (Age 19-44) 80% 71% 71% 69% 70% 65% 60% 44 - 50% 40% 30% % of % Pop US Age 19 21% 20% 21% 21% 20% 18% 17% 14% 14% 10% 0% 2013 2014 2016 2017 Private Government Uninsured *Patients can have more
Slide 60: Most Women Pay $0 For Birth Control
Most Women Pay $0 For Birth Control Since the ACA Was Enacted Percent of Women with $0 Copay for Birth Control Over Time (n=892 women age 18-39 with private health insurance who used a prescription contraceptive method) By spring 2014, mean and median out-of-pocket costs for the pill were $6.48 and
Slide 61: ACA Contraceptive Mandate
ACA Contraceptive Mandate: Current Status of Contraceptive Policy • Insurance plans must cover all FDA- approved methods with no copay or cost sharing to patients1 – They must cover at least one type of each method in each category • 62.8 million women (age 18-64) now have birth control coverage wit
Slide 62: Sildenafil Cream FSAD Demographic Insights & Concept Test
Sildenafil Cream, 3.6% FSAD Demographic Insights & Concept Test Market Research Report Conducted by Ad Hoc Research on behalf of Strategic Science & Technologies, LLC. 222 Third Street, Suite 2242, Cambridge, MA 02142 – December 2015
Slide 63: FSAD - Psychological & Physiological Impact
FSAD - Psychological & Physiological Impact 63
Slide 64: Experience of FSAD Sufferers
Experience of FSAD Sufferers 64 Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 41-47.
Slide 65: Experience of FSAD Sufferers
Experience of Female Sexual Arousal Disorder (FSAD) Sufferers 65 Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 41-47.
Slide 66: Indicators of Sexual Arousal
Female Sexual Arousal Disorder (FSAD) Respondents Indicators of Sexual Arousal * All respondents (n=402) * LT- in a long-term relationship SA - currently sexually active 35-54 - ages of 35 to 54 66 Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Wo
Slide 67: Signs & Symptoms
Female Sexual Arousal Disorder (FSAD) Respondents Signs & Symptoms All respondents (n=402) 67 Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 41-47.
Slide 68: Psychological Impact of FSAD
Psychological Impact of FSAD All respondents (n=402) 68 Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 41-47.
Slide 69: Psychological Impact of FSAD
Psychological Impact of FSAD All respondents (n=402) 69 Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 41-47.
Slide 70: Without an FDA Approved Product, Options are Suboptimal
Without an FDA Approved Product for FSAD, Women’s Options are Suboptimal All respondents (n=402) 70 Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 41-47.
Slide 71: Sildenafil Cream Product Profile Market Research
Sildenafil Cream, 3.6% Product Profile Market Research 71
Slide 72: Sildenafil Cream Concept Testing
Sildenafil Cream, 3.6% Concept Testing 72 Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 5.
Slide 73: Sildenafil Cream Concept Testing
Sildenafil Cream, 3.6% Concept Testing 73 Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 6.
Slide 74: Concept Testing - Cream Formulation
Sildenafil Cream, 3.6% Concept Testing – Cream Formulation 74 Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 10.
Slide 75: Concept Testing - Concept Acceptors
Sildenafil Cream, 3.6% Concept Testing – Concept Acceptors 75 Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 11.
Slide 76: Concept Testing - Purchase Interest
Sildenafil Cream, 3.6% Concept Testing – Purchase Interest • 82% of respondents * indicated they would be likely to purchase the product if it were currently available. • A subgroup of respondents aged 35-54 * LT- in a long-term relationship SA - currently sexually active had a higher purchase 35-54
Slide 77: Concept Testing - Believability & Viability
Sildenafil Cream, 3.6% Concept Testing – Believability & Viability 77 Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slides 5-22.
Slide 78: Concept Testing - Concept Appeal
Sildenafil Cream, 3.6% Concept Testing – Concept Appeal * • The majority of respondents (89%) considered the concept appealing. • The largest proportion of * LT- in a long-term relationship SA - currently sexually active respondents to consider 35-54 - ages of 35 to 54 the concept very appealing wer