Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (May 2019)
74 slides from Dare Bioscience's investor presentation, May 20, 2019
Slide 1: Accelerating innovation by daring to be different
Exhibit 99.1 Accelerating innovation by daring to be different May 20, 2019
Slide 2: Forward Looking Statements
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 SERVI
Slide 3: Vision and Mission
Vision: To become the premier innovation accelerator in women’s health. Mission: We achieve this by identifying, unlocking and advancing candidates with potential to be first-in-category, address persistent unmet needs, and promote a better quality of life for women. 3
Slide 4: Daring to be different
Daring to be different • A pure play biopharmaceutical company focused on improving the health and well being of women. Our focus areas include: • Contraception / Pregnancy Prevention • Sexual Health • Vaginal Health • Fertility • Partnering is core to our licensing and value creation strategy: • Pr
Slide 5: Product pipeline
gulatory a “ a > ee DARE-BV1" Phase 3 Initiation 4Q 2019 potential Firstine Option for BV Ovaprene® (PCT)’..... Top line 2H 2019 __First-in-category Non-Hormonal, Monthly Contraception Sildenafil Cream, 3.6% Top line 4Q 2020 First-in-category for Treatment of Female Sexual Arousal Disorder See DARE-
Slide 6: Portfolio Timeline Overview
Portfolio Timeline Overview 2019 2020 2021 2022 2023 2024 Current Development Status DARE-BV1^ U.S. Potential U.S. (Bacterial Vaginosis) Phase 3 Program Regulatory Review Launch U.S. Potential U.S. Ovaprene® Pivotal Regulatory Review Launch (Contraception) PCT* Study CDRH / Device Lead Sildenafil Cr
Slide 7: DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
Slide 8: 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 • 86% of evaluable subjects met clinical cure endpoint at Tes
Slide 9: Gel Delivery Technology
Gel Delivery Technology Features Description Innovative Product Profile Undergoes solution to gel (sol-to-gel) • Allows product to be easily and directly placed at the site of infection In-Situ Gelation transition using body temperature as • Increased viscosity following application keeping the prod
Slide 10: DARE-BV1 Proof of Principle Study Design
Bacterial Vaginosis DARE-BV1 Investigator Initiated Proof of Principle Study Design Study Objective: Study the Efficacy and Safety of DARE-BV1 in the Treatment of Bacterial Vaginosis (n = 30) Day 1 Day 7 - 14 Day 21 - 30 Baseline Visit Test-of-Cure Visit Continued Clinical Response Visit • Single do
Slide 11: DARE-BV1 Proof of Principle Results
Bacterial Vaginosis DARE-BV1 Investigator Initiated 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) 86% 57%*
Slide 12: DARE-BV1 Bacterial Vaginosis Opportunity Overview
DARE-BV1 Bacterial Vaginosis Opportunity Overview DARE-BV1 offers an attractive value proposition based on our belief that it has a low clinical risk profile, low development and regulatory costs, and an attractive commercial opportunity Proof of principal study complete o 86% clinical cure rate in
Slide 13: Contraception
Contraception Expected to be a $33 billion global category by 20231 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 14: 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 15: Ovaprene Overview: Hormone Product Innovation
New Contraceptive Option Ovaprene® Overview 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 Mirena Reduction of hormones and convenient product forms are driving new
Slide 16: Ovaprene Overview: Women's Preferences
New Contraceptive Option Ovaprene® Overview Women’s Preferences 1. Effective Pregnancy Prevention 2. Convenient Product Forms • Independent surveys revealed that the vaginal ring has many of the features women deemed extremely important.1 3. Method Mix • >70% of women who practice contraception curr
Slide 17: Current Contraceptive Landscape – what's missing?
Current Contraceptive Landscape – what’s missing? Hormone-free alternatives that are effective and easy to use 1 Least Effective Methods Hormone Free Product Landscape Marketed or in development 1,2 Spermicides / Vaginal Gels Effectiveness (72% Typical Use) Woman controlled Used “in the moment” Co
Slide 18: 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 19: Ovaprene Prior 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 2,3 • Open-label, single-arm, pilot safety and tolerability study. • Published in the Journal
Slide 20: 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 21: Ovaprene Design Features
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 22: Women's Sexual Health & Wellness
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 1. https://www.visiongain.com/sexual-dysfunction-drugs-market-will-reach-7-7bn-in-2019-predicts-a-new-visiongain-study/
Slide 23: 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 24: 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
Slide 25: FSAD Prevalence and Characteristics
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-a
Slide 26: Oral Sildenafil Efficacy in Women
Female Sexual Arousal Disorder (FSAD) Sildenafil Cream, 3.6% Increased blood flow and clinical efficacy with oral sildenafil (Viagra®) in women: • Statistically significant increases in Vaginal Pulse Amplitude (VPA)1 • Statistically significant improvement in genital stimulation (FIEI)2 Pfizer VPA C
Slide 27: 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 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 doses of Silden
Slide 28: Sildenafil Cream 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. Planned Type C Meeting At Home Study Content Vali
Slide 29: Sildenafil Cream upon approval
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% Upon Approval With its approval of Addyi®, FDA has now acknowledged and formally classified the distin
Slide 30: Innovative Vaginal Drug Delivery
$32 billion global category* Innovative Vaginal Drug Delivery Well characterized therapeutic options
Slide 31: Intravaginal Ring (IVR) Technology Platform
Intravaginal Ring (IVR) Technology Platform Daré has an exclusive, global license to novel IVR technology originally developed by Dr. Robert Langer from MIT and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School that has been further developed by Juniper Pharmaceutica
Slide 32: DARE-HRT1 Hormone Replacement Therapy
Hormone Replacement Therapy (HRT) DARE-HRT1 (bio-identical estradiol + bio-identical progesterone) HRT remains the most effective treatment for vasomotor symptoms (VMS) 4 and the genitourinary syndrome of menopause (GSM) and has been shown $2.2 Billion U.S. Market to prevent bone loss and fracture.1
Slide 33: DARE-HRT1 Phase 1 Study
Hormone Replacement Therapy (HRT) DARE-HRT1 (bio-identical estradiol + bio-identical progesterone) Phase 1 - 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 Para
Slide 34: Pregnancy Maintenance DARE-FRT1
Pregnancy Maintenance DARE-FRT1 (bio-identical progesterone) • Prevention of Pre-term Birth (PTB) • In the US, approximately 12% of pregnancies are preterm (less than 37 weeks)1 • Standard interventions include steroids, hormones and tocolytic agents to stop/slow the frequency and duration of contra
Slide 35: Vaginally Delivered Tamoxifen for VVA DARE-VVA1
Vaginally Delivered Tamoxifen for VVA DARE-VVA1 Vaginally Delivered Tamoxifen to treat VVA in HR+ Breast Cancer Patients • DARE-VVA1 • A proprietary formulation of tamoxifen for vaginal administration. • Potential to be the first treatment specifically approved for the treatment of vulvar and vagina
Slide 36: Vaginal Tamoxifen – Proof of Concept Study
Vaginal Tamoxifen – Proof of Concept Study1 This exploratory study in four postmenopausal women diagnosed with VVA demonstrated that a self-administered vaginal suppository containing tamoxifen (20mg) dosed daily for one week and twice weekly for three months was effective in reducing vaginal pH and
Slide 37: Strategic Pre-Clinical Candidates
$32 billion global category* Strategic Pre-Clinical Candidates Contraceptives that address global gaps
Slide 38: Long Acting Injectable Contraception ORB-204 and ORB-214
A New Long Acting Contraceptive Option Microparticle 6 & 12 Month Injectable Contraception ORB-204 and ORB-214, injectable etonogestrel The initial development on Orbis’ long-acting injectable contraceptive program was carried out under a subcontract funded by Family Health International (FHI 360) t
Slide 39: DARE-RH1 CatSper Contraceptive Target
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 40: Investment Highlights
Investment Highlights
Slide 41: Financial Profile
Financial Profile NASDAQ: DARE Balance Sheet, March 31, 2019*: • Cash: $3.5 million • Common shares: 11.42 million • Common stock warrants: 3.75 million • No debt *April 2019: Underwritten public offering of 5.3 million common shares for net proceeds of approximately $5.2 million. March 2019: Second
Slide 42: 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 ROTH Capital Partners, Citicorp Securities, Bank of America, Oppenheimer & Co. Chief Financial Officer David Friend,
Slide 43: Board of Directors
Board of Directors Daré Bioscience Roger Hawley Zogenix, Alios Biopharma, Cypress Bioscience, InterMune, Elan Corporation, GSK Chairman Jessica Grossman, MD Medicines360, Sense4Baby, Johnson & Johnson Susan Kelley, MD Bayer, BMS, ArQule, Cerulean Greg Matz CooperSurgical - Cooper Companies, Agilent,
Slide 44: Corporate & Investor Communications
Corporate & Investor Communications NASDAQ: DARE Trading as DARE since July 20, 2017 www.darebioscience.com 44
Slide 45: Appendix: Consumer & Market Insights
Appendix Daré Programs: Consumer & Market Insights
Slide 46: 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 47: BV Market Insights: ASHA National Survey
Bacterial Vaginosis Market Insights American Sexual Health Association (ASHA) National Bacterial Vaginosis Survey • 76% of women with BV stated they would have gone IF BV RISK FACTORS WERE KNOWN to see a healthcare professional sooner if they Would Seek Treatment Sooner were aware of the risks assoc
Slide 48: BV Market Insights: Impact on Daily Life
Bacterial Vaginosis Market Insights American Sexual Health Association (ASHA) National Bacterial Vaginosis Survey • According to the ASHA survey, IMPACT OF BV ON DAILY LIFE 62% of women mistake BV for 90 a yeast infection prior to diagnosis 80 • Most women with BV feel self- 70 conscious (68%) and/o
Slide 49: Ovaprene Market Insights
Ovaprene Market Insights Secondary Market Research & Market Sizing Data Prepared by SmartPharma, February 2019. Data on File.
Slide 50: US Contraceptive Population Continues to Grow
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 66.5 44 (MM) - 66.2 65.8 65 65.4 65.0 64.6 Females age 15 64 64.2 63.9 63.6 63 62 2016 2017 2018 2019 2020 2021 2022 2023 2024
Slide 51: 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 52: Negative Information About Hormones Persists
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 53: Contraceptive Pricing and Reimbursement
Contraceptive Pricing and Reimbursement Dare Bioscience – Ovaprene Market Assessment, Jan 2019 53
Slide 54: Brand Contraceptives Price Increases
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 55: 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 US Pop Age 19 21% 20% 21% 21% 20% 18% 17% 14% 14% 10% 0% 2013 2014 2016 2017 Private Government Uninsured *Patients can have more t
Slide 56: Most Women Pay $0 For Birth Control Since ACA
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 57: ACA Contraceptive Mandate: Current Status
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 58: 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 59: FSAD - Psychological & Physiological Impact
FSAD - Psychological & Physiological Impact 59
Slide 60: Experience of FSAD Sufferers
Experience of FSAD Sufferers Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 41-47. 60
Slide 61: Experience of FSAD Sufferers
Experience of Female Sexual Arousal Disorder (FSAD) Sufferers Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 41-47. 61
Slide 62: 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 Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women
Slide 63: FSAD Signs & Symptoms
Female Sexual Arousal Disorder (FSAD) Respondents Signs & Symptoms All respondents (n=402) Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 41-47. 63
Slide 64: Psychological Impact of FSAD
Psychological Impact of FSAD All respondents (n=402) 64 Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 41-47.
Slide 65: Psychological Impact of FSAD
Psychological Impact of FSAD All respondents (n=402) 65 Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 41-47.
Slide 66: Without an FDA Approved Product, Women's Options are Suboptimal
Without an FDA Approved Product for FSAD, Women’s Options are Suboptimal All respondents (n=402) 66 Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 41-47.
Slide 67: Sildenafil Cream Product Profile Market Research
Sildenafil Cream, 3.6% Product Profile Market Research 67
Slide 68: Sildenafil Cream Concept Testing
Sildenafil Cream, 3.6% Concept Testing Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 5. 68
Slide 69: Sildenafil Cream Concept Testing
Sildenafil Cream, 3.6% Concept Testing Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 6. 69
Slide 70: Concept Testing – Cream Formulation
Sildenafil Cream, 3.6% Concept Testing – Cream Formulation Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 10. 70
Slide 71: Concept Testing – Concept Acceptors
Sildenafil Cream, 3.6% Concept Testing – Concept Acceptors Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slide 11. 71
Slide 72: 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 had a higher purchase interest (86%) vs. the aggregate (82%). * LT- in a long-term relations
Slide 73: Concept Testing – Believability & Viability
Sildenafil Cream, 3.6% Concept Testing – Believability & Viability Source data on File: Research Report –December 2015; AD Hoc research - Sildenafil Topical Cream for Women Concept Test, slides 5-22. 73
Slide 74: 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 respondents to consider SA - currently sexually active the concept very 35-54 - ages of 35 to 54 appealing wer