Dare Bioscience, Inc.

Good afternoon. My name is Joanne, and I will be your conference operator today. At this time, I would like to welcome everyone to the DARE Bioscience, Inc. Q2 2022 conference call. All lines have been placed on mute to maintain the ground's noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. if you would like to withdraw your question again. Ms. Johnson, you may begin your conference.

Wonderful, thank you. Good afternoon and welcome to our second quarter 2022 financial results and business update call for Delaware Bioscience. Our plan today is to review our second quarter results, discuss development since our last call in May, and use the time to review our business strategy and highlight our objectives and milestones anticipated for the rest of 2022. Before we begin, I would like to remind you that today's discussion will include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical facts should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our annual report on Form 10-K for the year ended December 31, 2021, which was filed on March 31, 2022, and our quarterly report on Form 10-Q for the quarter ended June 30, 2022, which was filed today. I would also like to point out that the content of this column includes time-sensitive information that is current only as of today, August 9, 2022. DARI undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. As you know, DARI is solely and squarely focused in women's health. It is our belief that prioritizing women's health is not only good for the many women lacking effective or convenient therapeutic choices, but also for a broad set of stakeholders, including their families and partners and, of course, our shareholders. We work to accelerate innovative, differentiated product options in contraception, vaginal health, sexual health, and fertility, that expand treatment options where none exist, that enhance outcomes where current standard of care has meaningful shortcomings, and that improve ease of use for women where a more compelling form factor can drive adoption. Why? because these are compelling markets impacting millions of women and we have seen that innovation in these areas has led to commercially successful brands. Let's look at contraception. There are 73 million women in the U.S. ages 15 to 49. The first monthly intravaginal ring contraceptive NuvaRing peaked at 900 million annual revenue. The first hormone-releasing intrauterine system contraceptive Mirena peaked at 1.2 billion. and what about menopause? There are 47 million new entrants to the menopause and post-menopause market each year. The first estrogen hormone therapy, Premarin, peaked at $2 billion in annual revenue. And how about arousal problems? There are 10 million women estimated to have arousal problems significant enough to seek treatment. Now, while we can't point to the success of the first arousal product for women yet, since there is no FDA-approved product for female sexual arousal disorder, The first product for the analogous male condition, erectile dysfunction, Viagra, peaked at $2 billion in annual sales. Novel products that provide new features and flexibility have the potential to become meaningful brands. So what are the next big ideas in women's health? Well, at DARE, we believe these are the four novel contraceptive candidates or potential candidates in our portfolio. The first hormone-free monthly contraceptive candidate, Oviprene. First 6-12 Month Injectable, a DARE 204214 First Long-Acting Reversible Contraceptive System, DARE LARC1 And the Hormone-Free Contraceptive Target for Men and Women, DARE RH1 We believe it's the three vaginal health programs in our portfolio. Our FDA-approved product, Xaxiato, Clindamycin Phosphate Vaginal Gel 2% treatment for bacterial vaginosis in a single-dose vaginal administration. Our product candidate, DARE HRT1, the first hormone therapy bioidentical estradiol and progesterone monthly intravaginal ring. And our product candidate, DARE VVA1, the first hormone-free vaginal atrophy therapy for women with hormone-receptive positive breast cancer. We believe it's a sexual health product candidate in our portfolio, the first topical cream with the same active ingredient as Viagra being evaluated as potential first in category treatment for female sexual arousal disorder, FSAD. And the pregnancy management product candidates in our portfolio, DERA FRT1 and PTB1, IVR designed to release bioidentical progesterone over 14 days. So yes, it's our belief that prioritizing women's health is good for the many women lacking effective or convenient therapeutic choices and good for a broad set of stakeholders, including their families and partners, and yes, of course, our shareholders. And it's our belief that the programs in our portfolio represent a compelling opportunity overall, given that strategic partners are looking for meaningful market potential for differentiated products. Providers are looking for first-line and first-in-category product opportunities to address unmet patient needs. And investors are looking for a diverse pipeline with independent outcomes to mitigate risk and enhance the overall commercial opportunity. And women will continue to seek innovative options to help them navigate their needs and preference over the course of a lifetime. The DARE portfolio is built on these core principles, meaningful market opportunities, Product candidates for women with first-line or first-in-category potential and a highly diversified pipeline that often leverages well-known and well-characterized active pharmaceutical ingredients or API. And a great example of the execution of these core principles can be found in our FDA-approved product, Xaxiado. In the case of Xaxiado, use of a well-characterized API mitigated the development risk, the time, and cost as compared to new molecular entities. As with satiato, that 505 regulatory pathway that's possible for non-new molecular entities is planned for most of our development candidates. Why is that important? Well, 505 candidates have a 23% probability of success of advancing from phase one to approval and a 67% likelihood of success advancing from phase three to approval versus just 6% and 38% respectively for new molecular entities.

and let's talk about multiple delivery platforms.