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Transcript
OP
Operator
Operator
Welcome to the conference call hosted by Daré Bioscience to review the company's financial results for the year ended December 31, 2019, and to provide a general business update. This call is being recorded. My name is Jonathan, and I will be your operator today. With us today are Sabrina Martucci Johnson, Daré's President and Chief Executive Officer; John Fair, Chief Strategy Officer; and Lisa Walters-Hoffert, Chief Financial Officer.Ms. Johnson, please proceed.
SJ
Sabrina Martucci Johnson
Management
Thank you and welcome all of you to our financial results and business update call for Daré. It's a pleasure to have the opportunity to talk about our year-end results and our company highlights, and the upcoming milestones for 2020, and beyond.So, before I begin, I'd like to remind you that today's discussion will include forward-looking statements within the meaning of 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 fact 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, 2019, which was filed on March 27, 2020. I'd also like to point out that the content in this call includes time-sensitive information that is current only as of today, March 30, 2020. Daré 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, Daré is a biopharmaceutical company squarely focused on improving the life and wellbeing of women, primarily in the areas of contraception, vaginal health, sexual health, and fertility. Our value creation strategy is to accelerate innovation in women's health by advancing candidates that we believe have the potential to be first-in-category or first-line products to meaningful value inflection points, and delivering on key program milestones. I would be remiss if I did not start the call by addressing the potential for the COVID-19…
LW
Lisa Walters-Hoffert
Management
Thank you, Sabrina, and thanks to all of you for participating on this update call. I'd now like to summarize Daré's financial results for the full-year ended December 31, 2019. As you know, Daré's business model is to assemble, advance, and monetize a portfolio of novel product candidates in women's health. As a result, our expenses generally fall into three buckets: First, corporate overhead, second, costs associated with portfolio acquisition and maintenance, such as license fees and future milestones, and finally, research and development expenses related to clinical, non-clinical, preclinical work to generate safety and efficacy data, and advance our candidates through clinical and regulatory milestones.So, with that, for the full-year ended December 31, Daré's general and administrative expenses were $5.3 million. Our license expenses representing fees due under our various product candidate license agreements were approximately $530,000, and our research and development expenses for 2019 were approximately $8.5 million. The R&D expenses included the completion and related top line data readout of the post coital test clinical trial for Ovaprene, work to prepare for the initiation of the Phase 3 study for DARE-BV1, regulatory and other activities to advance Sildenafil Cream, preparatory work on two of our vaginal rings, one for hormone replacement and the other for pregnancy maintenance, these are DARE-HRT1 and DARE-FRT1, as well as personnel costs of our R&D team. Our comprehensive loss for the year was up $15.1 million.If I could just say, we had quite a bit of meaningful activity over the past two quarters. So let's start with the first fourth quarter of 2019. In Q4, we announced those positive top line results of the Ovaprene PCT study, which was a huge milestone for us. In Q4, we also announced the acquisition of Microchips Biotech, through which we acquired an exciting technology platform,…
JF
John Fair
Management
Thank you, Lisa. As we navigate our dynamic global health and economic environment, we will continue to focus on effectively executing against activities that position us to deliver on key program milestones and build additional incremental value in the portfolio. We believe the agreement with Bayer for our hormone-free monthly contraceptive candidate Ovaprene was significant validating event for Daré, and moving forward, we will execute against our broader business strategy of accelerating novel innovation in women's health and continue to engage with potential partners on subsequent collaborations and follow-on transactions.As we have discussed, we view partnerships as core to our business strategy and we will continue to evaluate collaboration opportunities and the timing of these opportunities in the context of what we believe will deliver the greatest value for our shareholders. We believe that the level of interest in our portfolio from potential strategic partners, really from our early stage programs, through our mid and late stage assets will enable us to provide significant value for investors and most importantly for women.And with that, I believe we will now turn it over to the Operator, who will open the lines for Q&A.
OP
Operator
Operator
Certainly [Operator Instructions] Our first question comes from the line of Jason Kolbert from Dawson James, your question please.
JK
Jason Kolbert
Analyst
Hi, guys. Thank you so much, really appreciate it. I just want to talk a little bit -- I mean, clearly, the acquisition of Microchips, which brought in cash was very, very smart, and I know, Lisa, you mentioned the outstanding share count, can you spend a little time with us -- and you also mentioned the [going] [Ph] concern, can you spend a little time with us and just talk about the cash runway and what we should expect as you cleared the hurdles to continue clinical progress? And I say that, I hesitate to say that because as we all understand, running clinical trials around the world right now is going to be likely delayed, and so, does it mean that you reduce spending a little bit in second quarter, extend the runway, and then maybe amp-up business development and look for some other ways to strengthen the balance sheet into the second-half. Thank you.
SJ
Sabrina Martucci Johnson
Management
Yes, so Jason, this is Sabrina. I'll give some context to the last part of your question around kind of how we can manage our resources, to your point, and then I'll turn it over to Lisa. And first and foremost, of course, we are a biotech company and therefore we always need to bring in additional capital at some point. And clearly we funded the company creatively, as Lisa said, since the beginning. So, I'll let her address that part. But to the second part of your question, in terms of how do we believe we're going to be on track to hit those milestones particularly in this environment, and how are we doing that.So, as I mentioned, and you kind of touched on it, it's a combination of the variety of the programs we have and where we are in those stages of development, and importantly the types of activities that we need to be doing to keep us on track. That actually gives us a lot of flexibility, and particularly the fact that we were not actively enrolling into any clinical studies gives us a lot of flexibility in terms of how we can recalibrate our resources and direct our investment as needed across the portfolio, but in ways that can meaningly advance them, particularly in this environment. So the flexibility really gives us some insulation from the uncertain market impacts of COVID-19 in this uncertain time, and gives us flexibility, kind of to your point that I think that you were getting at, on when and how we raise funds so that we can react quickly to changes in circumstances.And I just also want to highlight one thing that may not have been obvious, before I turn it over to Lisa, that I think is a…
LW
Lisa Walters-Hoffert
Management
Yes. So, this is a reminder, everyone, we did end the year with $4.8 million, and then subsequently raised about $7.9 million. I'm very happy that we did that. So to answer your question first, Jason, about going concern, to make sure everyone on the phone understands what that means. It means as of the time we filed, last Friday, so that was March 27, 2020, if you don't believe you have adequate cash through next year's March 27, 2021, you have a [going] [Ph] concern. So based on three active programs, some uncertainty on the timing, but these are later-stage programs. The cash that we currently have we don't believe is enough to get us all the way through to basically April of next year.In terms of financing strategies, and I know we sort of talked about this. One of the interesting parts for Daré is, again, sales of equity remain one of our options. We have an S-3 shelf. We have raised $11 million over the last -- beginning in January of last year. So we will continue to monitor our availability to use that, but we also have the opportunity which we are aggressively exploring for non-dilutive grant funding. Recall that the grant for Ovaprene basically funded the variable costs, if you will, not all of our salaries, but the variable costs associated with the Ovaprene PCT. There is money available out there. We are doing our best to be creative, and clever, and keep our eyes open and apply for those grants. So that's something that we are actively watching and doing, and then, of course, partnering fees. John has said it to you, our portfolio is finally getting to that point where it's in later stage and we're starting to have data readouts. That's when investors of all kinds including strategic start to get -- to take some interest. So our goal is to kind of manage these various buckets of financing. And you're right, we'll have to keep an eye on what the impact of COVID is, if things would -- basically it would slow down, but mostly likely things may be a little bit slower.
JK
Jason Kolbert
Analyst
Thank you, guys, and thanks for taking that very directly and clearly. I really appreciate that.
LW
Lisa Walters-Hoffert
Management
Thank you.
SJ
Sabrina Martucci Johnson
Management
Hope it was helpful.
OP
Operator
Operator
Thank you. Our next question comes from the line of Nathan Weinstein from Aegis Capital, your question please.
NW
Nathan Weinstein
Analyst
Hey guys, congrats on the progress and thanks for taking my question. So, I was just hoping we could step back and look at or maybe you could opine a little on the overarching theme of your pipeline, just specifically how your various products could help improve patient choice in the market. Maybe there's been some underinvestment at an industry level in focusing on those. So how maybe some of your products could help patients have more choice?
SJ
Sabrina Martucci Johnson
Management
Yes, Nathan, thank you for that. This is Sabrina speaking. And it's a great opportunity to remind everyone why Daré exists, and really what the value creation opportunity here is at Daré. And you really touched on it, is there are a number of really compelling and interesting unmet needs in women's health. And we've touched on some of them with products, like Ovaprene, for its potential monthly hormone-free contraceptive; Sildenafil, first product for female sexual arousal disorder, which as I shared with those - the number of number of women statics versus ED in men, I think you get a sense for how much demand there is out there for that, but there really hasn't been an industry focus on developing despite the fact that as we demonstrated, as we've built our portfolio, selecting products that address some of the most persistent unmet needs in women's health that have these first-line and first-in-category opportunities, while often, like Sildenafil, leveraging that 505(b)(2) regulatory pathway, and with BV1, which means that you're using a well-known and well understood product. There's a lot of data to show that 505(b)(2) products often have a faster time to approval and a higher success rate. We're able to leverage that but still have first-in-category product opportunities because we are delivering them often in a way that really takes advantage of the unique female biology. Again, think BV1 delivered vaginally, think Sildenafil Cream delivered topically to the genital tissue.So while on the one hand there is great innovation, there is unmet need, all of that is outstanding. But the fact that there is a lack of industry investment in development while there are nonetheless companies, like Daré, as was exhibited with our Ovaprene transaction, that are looking for truly differentiated disruptive products to add to their portfolio, it really creates this very unique business dynamic that we have built Daré around, this accelerator opportunity that we think really has an opportunity to drive value. And not just around one program or two programs, but several in the portfolio. And so, hopefully that addresses your question of what we're trying to do and why we think the opportunity exists. But frankly, importantly for investors hopefully that gives everyone a sense of what the value opportunity is here with our portfolio, and what that means in terms of where we should be as a company, not based on just one of our products, that I mean we have three late-stage assets.
NW
Nathan Weinstein
Analyst
Thank you, Sabrina, that's really helpful, and we continue to watch your guys' progress with enthusiasm.
SJ
Sabrina Martucci Johnson
Management
Thank you. Thank you, Nathan.
OP
Operator
Operator
Thank you. [Operator Instructions] Our next question comes from the line of Sally [indiscernible] from Brooklyn Capital, your question please.
UA
Unidentified Analyst
Analyst
Very good, okay. All right, here's the credit card, it's…
SJ
Sabrina Martucci Johnson
Management
Hi, Sally. Sally?
UA
Unidentified Analyst
Analyst
8210…
SJ
Sabrina Martucci Johnson
Management
Sally, I…
LW
Lisa Walters-Hoffert
Management
Please mute her. We don't want to hear her credit card number, Operator.
OP
Operator
Operator
Okay, great. [Operator Instructions] And this does conclude the question-and-answer session of today's program. I'd like to hand the program back to Sabrina Martucci Johnson. Please go ahead.
SJ
Sabrina Martucci Johnson
Management
Thank you. Well, thank you all for taking the time this afternoon, and thanks for the great questions that we had an opportunity to answer. We definitely look forward to keeping you updated on our progress, and we're really grateful to the entire Daré team, of course, and particularly our shareholders for their commitment and dedication to our mission, and particularly during these times. So, thank you so much, and we look forward to keeping you updated.
OP
Operator
Operator
Thank you ladies and gentlemen for your participation in today's conference