Daré Bioscience
DARÉ
IN ITALIAN, IT MEANS "TO GIVE."
IN ENGLISH, IT MEANS "TO BE BOLD."
NASDAQ: DARE www.darebioscience.com
Corporate Presentation: December 15, 2022 | ©2022 Daré Bioscience | All rights reserved |
Forward-Looking Statements; Disclaimers
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 publications, and other sources. Daré has not independently verified such information and there can be no assurance as to its accuracy.
All statements in this presentation, other than statements of historical fact, are forward-looking statements within the meaning of federal securities laws. In some cases, you can identify forward-looking statements by terms such as "may," "will," "expect," "plan," "anticipate," "strategy," "designed," "could," "intend," "believe," "estimate," "target," or
"potential," or the negative of these terms and other similar expressions. Such statements include, but are not limited to, statements relating to the clinical and market potential of
XACIATOTM (clindamycin phosphate) vaginal gel, 2% and Daré's product candidates, clinical trial advancement, timing and data, regulatory approval and commercialization, potential collaborations, expectations regarding existing collaborations, pipeline expansion, and potential funding and financing transactions. As used in this presentation, "first-in- category" is a forward-looking statement relating to market potential of a product candidate if it were to receive regulatory approval for the indication(s) for which it is being developed. None of the product candidates presented herein are approved for use outside of clinical trials. The timing of clinical trials, clinical trial data, FDA review and approval, collaborations and other milestones and events relating to development and commercialization of XACIATO and Daré's product candidates, other than those having occurred prior to the date of this presentation, are forward-looking statements. Forward-looking statements reflect management's estimates and expectations based on current information and involve risks, uncertainties and assumptions that may cause Daré's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements, including, without limitation: Daré's reliance on third parties to commercialize XACIATO and to manufacture and conduct clinical trials of its product and product candidates; the degree of market acceptance that XACIATO and any future product achieves; the coverage, pricing and reimbursement that XACIATO and any future product obtains from third-party payors; risks and uncertainties inherent in Daré's ability to successfully develop, obtain regulatory approval for and monetize its product candidates; Daré's need for additional capital to execute its business strategy; and those risks and uncertainties described in Daré's most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the Securities and Exchange Commission under the heading "Risk Factors." All forward-looking statements are current only as of the date of this presentation. Daré does not undertake any obligation to update any forward-looking statement in this presentation to reflect new information, future developments or otherwise, except as required by law.
All trademarks, service marks or trade names appearing in this presentation are the property of their respective owners. Unless specifically identified as such, Daré's use or display of third-party marks is not intended and does not indicate or imply any relationship with or endorsement or sponsorship of Daré by the third-party owner.
2
Women's Health is Our Sole Focus
Daré Bioscience is a biopharmaceutical company committed to addressing the lack of innovation in women's health with differentiated products that address unmet needs primarily in the areas of contraception, fertility, vaginal, and reproductive, menopause, and sexual health.
We work to accelerate innovative product options in women's health that…
Expand treatment options where none exist,
Enhance outcomes where current standard of care has meaningful shortcomings, and
Improve ease of use for women where a more compelling form factor can drive adoption.
We partner to…
Drive innovation and develop new solutions,
Accelerate novel products to
address persistent unmet needs in a time and capital
efficient manner, and
Establish and take to market a differentiated pipeline with compelling commercial potential.
We look for differentiated investigational products with…
Attractive market opportunities + unmet
medical needs,
Prior human proof-of-concept and/or ability to leverage a 505(b)(2) regulatory pathway,
First-in-category or first-line target product profile potential, and
Opportunity to personalize for women with novel, convenient routes of administration that have the potential to improve ease of use and side effect profile.
3
Women's Health - An Efficient Investment Thesis
[
[Women's Health conditions outside of oncology comprise less than 2% of the current healthcare pipeline.2
1 -McKinsey & Company, February 14, 2022, Unlocking Opportunities in Women's Healthcare2 - GlobalData Drugs Database and McKinsey & Company
3 - IQVIA Monthly Global MIDAS $ Const-Exchng (MNF) 2013 - 2022 Blockbuster defined as $500 million dollar sales in a year
Women's Health including conditions solely or disproportionately affecting women;
We believe investment in women's health
will be efficient and
disproportionately impactful:
- Women's Health products make up
27% of total blockbuster products
while contributing to
35% of total blockbuster sales.3- Women control 80% of U.S. healthcare purchasing decisions.1
4
excludes oncology conditions in women
Women's Health - Compelling Markets Where Innovation Matters
Contraception
~73 million women ages 15-491
1st hormonal monthly IVR, NuvaRing, ~$900M at peak2 1st hormonal IUD, Mirena franchise, ~$1.2B at peak3
1st copper IUD, still ~$200M/yr 40 years post launch4
Reproductive, Menopause, and Sexual Health
- 47 million new entrants to menopause and post- menopause market each year6
1st estrogen hormone therapy, Premarin, ~$2B at peak7
- No FDA approved product for female sexual arousal disorder, despite similar prevalence to erectile dysfunction
1st drug indicated for ED, Viagra, $2B at peak8
What are the next big ideas?
Vaginal Health
- Bacterial vaginosis affects ~21 million women in the US; but current Rx clinical cure rates 37-68%5
Fertility
- 15M babies (11.1% of all live births) are born pre-term every year9
- U.S. fertility pharmaceutical sector, estimated to be $1.5B10
1st preterm birth drug, Makena, ~$400M at peak11
IVF follicle stimulating hormone + luteinizing hormone, Menopur, ~$570M in 202012
- Source: CDC National Survey for Family Growth,2015-2017 dataset, cdc.gov.
- https://sec.report/Document/0000310158-20-000005/
- https://www.bayer.com/en/bayer-ag-annual-report-2019.pdfx.Includes sales for Mirena®, Kyleena® and Jaydess® / Skyla®
- https://investor.coopercos.com/static-files/27c058fe-5d74-4899-aa12-6db1258b23f4
- https://www.cdc.gov/std/bv/stats.htm; Bacterial vaginosis product data: http://www.clindesse.com/pdf/PI.pdf; http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205223s000lbl.pdf; http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205223s000lbl.pdf
- https://www.bayer.com/en/ca/bayer-starts-phase-iii-clinical-development-program-oasis-with-elinzanetant.
- https://www.wsj.com/articles/BL-HEB-176
- https://www.reuters.com/article/us-pfizer-britain-viagra/uk-gives-pfizer-worlds-first-over-the-counter-viagra-approval-idUSKBN1DS1Z1
9. | Organon 1Q2022 earnings call | 5 |
10. | https://www.harriswilliams.com/sites/default/files/content/fertility_industry_overview_-_2015.05.19_v10.pdf | |
11. | https://www.latimes.com/business/story/2022-02-17/makena-covis-premature-birth-pregnant-womens-health | |
12. | https://www.ferring.com/wp-content/uploads/sites/16/2021/03/Ferring-2020-Annual-Report-2020_Final_Digital_Spreads.pdf |
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Dare Bioscience Inc. published this content on 09 January 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 January 2023 13:38:08 UTC.