Daré Bioscience, Inc.
Q4 2020 Earnings Call Transcript

Published: 30 Mar 2021

[Operator:]

Welcome to the conference call hosted by Daré Bioscience to review the Company's Financial Results for the Year Ended December 31, 2020, and to provide a general business update. This call is being recorded. My name is Sarah, and I will be your operator today. With us today are Sabrina Martucci Johnson, Daré's President and Chief Executive Officer; John Fair, Daré's Chief Strategy Officer; and Lisa Walters-Hoffert, Daré's Chief Financial Officer. Ms. Johnson, please proceed.

[Sabrina Martucci Johnson:]

Thank you. Good afternoon and welcome to our 2020 financial results and business update call for Daré Bioscience.

[John Fair:]

Thank you, Sabrina. We're entering an exciting time for DARE-BV1 as the NDA submission will move us one step closer to the introduction of this important new product for the treatment of bacterial vaginosis. We continue to be impressed with the level of interest in the product candidate as we are seeing broad activity from large strategic pharmaceutical manufacturers as well as emerging specialty healthcare companies interested in adding a new and differentiated product to their portfolio. As we’ve communicated in the past, we look forward to announcing our commercialization strategy for DARE-BV1 following the execution of a definitive agreement. However, because we're often asked about timing, I wanted to start by providing some context on our process. I can reiterate that we believe it's in our best interests to continue to advance our partnering discussions in parallel with our regulatory discussions which we believe derisks and adds value to the DARE-BV1 program. We have the flexibility to work in parallel because of the clinician awareness of bacterial vaginosis and the straightforward product profile of DARE-BV1 which mitigates some of the traditional market softening efforts required with an NTI or a new therapeutic indication. We believe that we are positioned to execute a definitive commercialization agreement before the end of the year. And as we think broadly about our commercialization strategies, we also have considerable optionality on what type of commercialization partnership structure we can contemplate. The fact that we have a portfolio of multiple women's health products in development means that all forms of structures are viable from direct involvement in commercialization to a collaboration with a contract sales organization, to a complete commercial out license, similar to the deal we executed with Bayer for Ovaprene where Bayer has complete responsibility for commercialization. Being able to play a role in the commercialization of DARE-BV1 is much more tenable for us today than it was 18 months ago. And the reasons for that are driven by the appreciable reduction in the size and scale of a field force that we believe would be required to reach the target number of healthcare providers to make the brand successful. With the implementation of remote and virtual provider detailing, driven almost entirely by the COVID-19 pandemic, organizations like ours can achieve a much greater efficiency and scale more quickly, with fewer full time resources and that's with a reduced expense. Doctors have adjusted their workflow to accommodate virtual visits with sales representatives and we believe this will continue even after the pandemic is over. All of this taken together provides us greater optionality to pick the commercialization partnership structure that we believe is best suited for DARE-BV1 for patients and for our shareholders. In summary, given the data from the DARE-BV3 Phase 3 study and the compelling value proposition of DARE-BV1, all options are on the table. Turning briefly to Ovaprene. I want to reiterate some of the comments Sabrina made about the Bayer partnership, we believe our relationship with Bayer continues to be value additive for both companies. Our two organizations are operating synergistically across a number of key work streams, ranging from manufacturing Regulatory Affairs, medical affairs and brand planning, which includes pre-commercialization planning. We anticipate that this collaboration will only grow stronger in the coming months, as we plan to coordinate our efforts both internally and externally in preparation for the filing of the IDE later this year and enrollment of the pivotal clinical trial in 2022. Finally, I wanted to say a few words about the strength of the Daré brand in the broader women's health ecosystem. We have been and will continue to be active on a number of fronts to seek to continue to drive value into and through our pipeline. What's new about that for this year is that Daré, the Daré brand has been elevated and our success both on the development side and the partnering side has translated into real interest from a variety of stakeholders to help us continue to develop and deliver new and differentiated products into the category. So we are really excited to embark on what we think is the next growth phase for Daré and look forward to keeping you updated as collaboration, exploration and discussions advance. With that I will turn the call over to Lisa.

[Lisa Walters-Hoffert:]

Thank you, John. And thank you all for joining us today. I share Sabrina and John's excitement and I'm grateful to our entire team for their incredible efforts over the past year. I would now like to summarize Daré's financial results for the year ended December 31, 2020. Daré business model is to assemble, advance and monetize a portfolio of novel product candidates in women's health. As a result, our expenses consist of corporate overhead, portfolio acquisition and maintenance costs and research and development activities to generate the clinical and other data necessary to advance our candidates through regulatory milestones, including approval. For the year ended December 31, 2020, Daré's general and administrative expenses were approximately $6.5 million; licensed expenses were approximately $83,000 and research and development or R&D expenses were approximately $20.8 million. In addition to personnel costs of our R&D team, the years R&D expenses primarily reflect the costs of the DARE-BV3 Phase 3 study, activities related to Ovaprene and preclinical development activities for DARE-LARC1. And as you know the DARE-LARC1 program is supported by our grant from the Bill and Melinda Gates Foundation. Our comprehensive loss for the year was approximately $27.4 million. During the year, net cash proceeds from financing activities were approximately $25.1 million and represented sales of stock, the exercise of warrants and loan proceeds. Total cash received during the year 2020 was approximately $29.5 million. Reflecting the financing activities I just described, as well as cash from grants, a license fee payment, and the Australian R&D incentive cash rebate. We ended the year with approximately $4.7 million in cash and cash equivalents. Following year end to between January 1 and March 29, 2021, Daré received additional cash of approximately $11.5 million, consisting of approximately 11.3 million net of fees from sales of common stock under our ATM program in Equity Line facility, approximately 50,000 from warrant exercises and approximately $139,000 program funding. Following these activities, as of yesterday, March 29, shares of common stock outstanding were approximately 47.3 million. In late January, Daré public float exceeded $75 million, meaning that we could use our existing form S3 shelf registration statement without being subject to the restrictions imposed by the SEC baby self rules. A public float that exceeds $75 million adds tremendous flexibility and could enable us to explore a variety of financing options that were not available to us in 2019 or 2020. We intend to file the new form S3 shelf registration statement with the SEC that will replace our existing shelf registration and which once effective can be used over the next three years, allowing us to explore different financing options over time. As we have done in the past, we will attempt to do so in a manner that protects and enhances shareholder value. In addition to my comments, there are a few agreements, commitments and arrangements worth highlighting given that they should collectively serve to reduce our costs of development during the coming year 2021 and help us manage our cash resources efficiently. First, grants; grants have been an attractive source of non-dilutive funding for Daré and we recognize grant funding in our statement of operations as a rejection to research and development expenses. During 2020, we recognized 3.7 million of grant funding as an offset to our R&D expenses related to Ovaprene, DARE-LARC1 and DARE-FRT1. To-date, we have received grant monies from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the Bill and Melinda Gates Foundation. We will continue to use our existing grants for allowable expenses, and we intend to continue to explore and to apply for additional grant funding in the future. Second, the terms of our agreements which helps decisions in provide for commitments of certain staff resources as well as expense rate reductions for development activities related to our programs. These arrangements are expected to provide additional time and cost efficiencies in 2021 as well. And finally, as Sabrina had mentioned, under Australia's research and development tax incentive program, we received approximately 192,000 in cash during 2020 and during the first quarter of 2021 we applied for a refundable cash credit of $268,000 based on the eligible expenses incurred in connection with our DARE-HRT1 based on clinical study. Currently, the program allows for eligible companies to receive up to 43.5% of their eligible R&D expenses. We will continue to explore a variety of ways to raise capital to advance our product candidates and to satisfy our working capital needs. Since inception, we have raised cash through the sale of our equity, for M&A transaction, warrant and option exercises, non-dilutive grants and license fees. We will endeavor to be creative and opportunistic in seeking the capital we need to build value as we advance our candidates and to be highly efficient in the use of such capital. A word about COVID-19. We are continuing to monitor the pandemic and its potential impact on many aspects of our business. Due to the many uncertainties surrounding the pandemic, including vaccination rates and efficacy rates and governmental responses, we are unable to predict with any reasonable accuracy the full financial and business impact on our company at this time. We encourage investors to review the more detailed discussion of our financials and financial condition, our liquidity and capital resources and our risk factors which will be filed in the 10-K with the SEC. Now, as you know, we typically file our 10-K, about a half an hour before our earnings call but as luck will have it today, the SEC Website was down. So keep an eye out and we will file that 10-K as soon as we can. I would now like to turn the call over to the operator for Q&A.

[Operator:]

Thank you for attending the conference call. Our first question comes from the line of Zegbeh Jallah with ROTH Capital Partners.

[Zegbeh Jallah:]

Hi, guys, thanks for all the updates, a lot of different programs are ongoing. So it's really nice to kind of know what the update is on each of them. So it's just starting with the first one year for DARE-BV1, was just kind of curious, if you were not to get the priority review, would we expect an approval say in March?

[Sabrina Martucci Johnson:]

Yes, great. And this is Sabrina. So great question. Yes, the priority review allows a six month review from the day you file because this is 505b(2) pathway. So from the day we file. If it's not priority review, then yes, you would expect the PDUFA to be towards the end of the first quarter.

[Zegbeh Jallah:]

Perfect. Thanks Sabrina. And then in terms of the partnership, I know John mentioned that, a lot of the positives of being able to do remote and virtual as well as a really established market love the products, you guys can be more involved. And so, I was just wondering, in terms of kind of boosting your cash balance, are you going to prioritize upfront cash, or that is not a priority. We're just looking for someone that can really handle the launch?

[Sabrina Martucci Johnson:]

That is really an exceptional question. And so let me try to articulate how we look at it. We really are looking at what is the best partnership for this asset, right? What is the best partnership that is going to maximize the accretive potential to Daré to our shareholders and, frankly, access to women? Because that isn't, that's the beginning and the end what matters and what gets you there right. So what is that best partnership structure? And there are a number of things we're looking to balance in that equation. So we're looking for who is best position to commercialize it successfully to the target clinicians whose best positioned to deliver that message and whose best positioned to give the product the attention that it deserves in order to achieve its value and success. And how does our big picture, Daré objectives beyond DARE-BV1 into that. And so I think, what you saw with Ovaprene should give you a sense of how we think about this. We take each asset on its own merits. So as we talked about today, with Ovaprene, we felt that it was absolutely critical to that program to have the only company that has, in recent days, built a brand new contraceptive category, successfully launched into that category and created a billion dollar brand as the partner. And so we didn't feel with that program that it made sense for us to have any involvement with that program, it was the right thing to do to hand it off to Bayer. As we think about DARE-BV1, for all the reasons I and John communicated on this call, this particular program for a lot of reason gives us a lot more optionality and how we think about partnerships, and how we think about that trade off that you mentioned. So just like Ovaprene, there was trade off, do you take a lot of money upfront? Or do you take more on the back end? And who's going to make the product as big as it can possibly be? And who do you want by your side to do that? So just like we did with Ovaprene, we'll look at all the possibilities and as with Ovaprene, we are very fortunate to be advancing programs that people are excited about. That the partnership landscape is excited about and that gives us optionality. So I know I did not directly answer your question because I can't. But hopefully I gave you enough perspective that we are absolutely weighing all of that. We're weighing the value of the near term dollars that could come in under certain deal structured towards less, on the front end versus the pros and cons of us having some ability to play a role in this process and how all of that also translates into cash flows. And just like we talked about with the Bayer deal where partnerships also our way of funding non-dilutively, how that translates into all that as well. So, stay posted, as John mentioned, we will definitely keep people updated. And hopefully you got some clarity today that, as these discussions are progressing, and as our regulatory process towards that NDA is progressing, we're finding it definitely is in our best interest to keep the conversations going in parallel and not to rush the process so that we get the best outcome for our shareholders.

[Zegbeh Jallah:]

Thanks Sabrina. And then, regarding Ovaprene thanks for the color on some of that pre-commercial activities that are kind of underway. It was just curious as to what might be driving the timing of the IDE, what has been happening, just some additional clarity on that. And I think I just had another quick one here, as well, in terms of the timing of the next milestone payment, because you said that could be helpful for even supporting evolvement of the rest of your pipeline as well.

[Sabrina Martucci Johnson:]

Two more great questions. So in terms of the IDE process, so as those of you who've been following Daré for a while, you may remember that that we were hopeful to get Ovaprene, moving faster, right at the beginning of the -- before the COVID pandemic in early 2020. We had our sights on getting going faster with the Ovaprene program. With the COVID pandemic and also with the opportunity that actually the regulatory pathway that Ovaprene goes through which is a CDRH pathway. It's a PMA. It allows things that you don't get to do during the CDRH pathway, it allows for almost unlimited opportunities to have pre-submission meetings with the FDA and talk about things. There was also manufacturing and non-clinical work that we always knew would be required as well. And so in light of all those factors, we recalibrated the timeline for the program, while at the same time balancing what was always one of ours and Bayer's objectives, which was to have some data in 2022, right, as we were kind of looking forward towards the regulatory process. And so what we've been doing over this period is some of that non-clinical work, the studies that are required for any kind of regulatory filing in terms of different, you know, safety talks, all that stuff. It's a little bit different when you're going through the PMA process than an NDA. But nonetheless, that those types of activities, manufacturing activities, as I mentioned. We've spent more time planning the pivotal studies that we've used the luxury of not wanting to start this particular trial, right in the midst of the pandemic, just because it's a contraceptive study and we have heard from all of our advisors that contraceptive studies are particularly -- have been particularly challenging during COVID environment and are very close collaborators at NIH, who had funded the pre-pivotal study had guided that they had actually stopped a number of their studies. So for all those reasons, we focused on other things. So that is what's driving it, the timeline and looking at getting that filing in the end of this year. And then, to your question of the readout in 2022 and how that aligns with the milestone payment from Bayer, which is really I think what you're asking the 20 million milestone payments for the pivotal study. As I mentioned in my comments, part of our discussions with the FDA, they will not be able to be finalize until the IDE is cleared is, finalizing alignment on the duration of the pivotal studies, 6, 12 months what kind of data exactly is required. Hormone free products have typically been -- devices have been six months, but monthly vaginal contraceptive products have been 12 months. So discussions with the FDA on duration. We know though from contraceptive products that clinical outcomes at six months are very predictive of what you're going to see at 12 months, these are going to be the same at 12 months or even slightly potentially better at 12 months contraceptive rates don't go down between six and 12 months. So we've aligned that whatever the ultimate package is that needs to be submitted to the FDA, we as long as we start the study next year, we will be in a position to read out six month contraceptive data by the end of 2022. Whether or not that triggers the milestone payment of the contract is going to depend on what the ultimate required pivotal study is, what the final pivotal study is, whether it's six or 12 months because that payment is due based on a certain timeframe. We haven't disclosed all the details are redacted in the confidential treatment request in the filing that's with the SEC on the contract, but it's payable on a certain time after completion of the study. So if the six months contraceptive effect is not the completion, if that completion is not right there, 2022, but it's in 2023 that's when that timing would happen.

[Zegbeh Jallah:]

Thanks for the additional detail Sabrina. And then, just one last for me, as for your HRT1 just wanted to get some more details on, what are you hoping to see from the data? How should we interpret the data when it does come out? And then perhaps maybe even put in the context of how the readout could -- put you in a good position for subsequent next step?

[Sabrina Martucci Johnson:]

Yes. And then, I'll let move on to the next question in the queue after this one, you've had awesome questions. So I'm excited to get to answer these. On HRT1, to your point, so the data is going to come in the second quarter. And it's Phase 1, right, so we're really looking at PK data, we're looking at drug release data over this 28 day period and to see that we've met our objectives. As you may recall, this work has already been done in sheep. Sheep are a great model for vaginal ring technologies, because you can use full form factor for human vaginal ring in the sheep. So we've already demonstrated this in sheep. So this is an opportunity to do this now in women, obviously, importantly, and also to similar to what was done in sheep, see if there's any adverse events vaginally that are unexpected. So those are really what we're going to look for, we're going to look at confirmation of that same nice PK data that we saw on the sheep. And we're going to look for both of the two actives that progesterone and estradiol. And then, we're also going to look at those any vaginal effects. And in terms of why it's also interesting for the FRT1 program, which is the progesterone program, where we have the NIH funding up to 2.3 million to support the Phase 1 is because it's the same progesterone and we are looking in the HRT at some of the same doses, not all the doses, but some of the same doses that we would consider for the progesterone rings. So it's actually kind of a nice, early peek at what those PK data might look like. So it also helps us plan for that Phase 1, where we're collaborating with the NIH for FRT1. And then, obviously, next step would be for the HRT1 program to progress it into Phase 2, which once we have the Phase 1 data, we can decide how we want to proceed with that program.

[Operator:]

Our next question comes from the line of Jason McCarthy with Maxim Group.

[Joanne Lee:]

Hi, this is Joanne Lee on the call for Jason McCarthy. Thanks for taking the questions and congratulations on your progress in the quarter. For my first question, I guess it's regarding DARE-BV1, we all saw the great data you put on the fourth quarter for the BV1 asset, which was in line with the previous results announced earlier in the study. I understand NDA submission is planned for Q2. I was just wondering if there's been any recent discussions with the FDA and what were some of the responses you heard? Or if not, do you guys plan on having a sort of a pre-NDA meeting with the FDA? Or we're obviously looking forward to the submission and announcement of the PDUFA date?

[Sabrina Martucci Johnson:]

Yes, absolutely. So we had guided previously and thanks for the reminder, because I'd neglected to mention on today's call and I probably should have. We had guided previously that we would definitely have pre-NDA discussions with the FDA. Hopefully you've gathered even some from Ovaprene comments that we like to take advantage of opportunities to engage with the FDA. We've done it a lot on our Ovaprene program, Sildenafil program and absolutely similarly on DARE-BV1. We find those pre NDA discussions. Well, any of the meetings that we have with the FDA, but pre NDA discussions are obviously a really helpful way to do everything a sponsor can to mitigate risk with your submission, right to make sure that anything that you have questions about, you have an opportunity to ask them. And then, you can take the FDA's guidance and suggestions and advice into consideration as you prepare the NDA. So, yes, that is something that we do as a company and we never disclose the exact timing of those events and exactly where we are in that process. But absolutely pre NDA communication with the FDA is a critical and important part of our NDA filing strategy.

[Joanne Lee:]

Great. That was helpful. Thank you. So there's been a lot of exciting activities surrounding the BV1 asset but I sort of shifting focus to the FSAD program, it was nice to hear that the Phase 2b study initiated earlier this year, assuming the results at the end of this year are positive. Could you briefly just walk us through what are some of the future steps for the company following completion of this current study to get the Sildenafil cream onto the market?

[Sabrina Martucci Johnson:]

Yes. And thank you for asking about that product, because I hate to use the word excited when I'm talking about that product. But it is really a better way to describe it, like we have been very excited about starting the study. This was another one that we had really had hoped to enable to start last year. And we just felt that last year was not the right year with all the uncertainties to start this trial. So we were chomping at the bit to get this study going because it is such an interesting program. It's such a significant unmet need. We had reached the alignment with the FDA on the primary endpoint and we announced that at the end of 2019. So this is definitely something we were looking forward to getting going. So we're very excited. And what you may -- those of you who are involved at that time may recall that part of our discussions with the FDA to align on the Phase 2b design and the end point was to really start laying the foundation to your question of what does the entire program look like? What does a Phase 3 look like? What are the expectations because their guidance document which is out there, there's a 2016 guidance document. It leaves a lot kind of open to the sponsor and open to the sponsor to discuss with the FDA. So in terms of what we expect next. So this Phase 2b is designed to use as a primary endpoint, what came out of our content validity work as likely the best primary endpoint to take forward into Phase 3. But part of the alignment with the FDA was that this study would include a number of exploratory secondary and exploratory endpoints that also looks very good in our content validity works. So an important aspect of the Phase 2b is picking what is the right endpoint, it may be the one we picked as primary, it may be a different one to take forward into the Phase 3 program. So that really is an important consideration in the Phase 2b. And in terms of what the Phase 3 will look like, then, the guidance document with the FDA does currently stipulate 24 weeks' duration versus 12 weeks that we have in the Phase 2b. It's not clear whether that will continue to be the standard for female sexual arousal disorder that was really designed around hypoactive desire disorder, which is a CNS condition. So that is certainly going to be an area of discussion. But right now, the guidance says 24 weeks study for Phase 3. And we have already discussed with the FDA that we would need two Phase 3. So while this is a 505(b)2 program, because we're leveraging the safety of Sildenafil, it's oral Sildenafil in men for different indications. And this is vaginal administration. So the expectation will be two Phase 3 trials. So after the Phase 2b hoping for success, the next step would be to have that end of Phase 2 meeting with the FDA and align on the Phase 3, based on that, and then get going.

[Joanne Lee:]

Okay. Thank you so much for those details and, again, for taking the question. We're really excited to hear any additional updates in the coming quarter.

[Operator:]

Our next question comes from the line of Douglas Tsao with H.C. Wainwright.

[Douglas Tsao:]

I'm just curious. With the hormone replacement therapy products going into Phase 1. When we look at your portfolio, you sort of taken different approaches in terms of when you want to partner assets. Have you given sort of initial thought when or how far along in terms of development, you would want to take those?

[Sabrina Martucci Johnson:]

Doug, thank you for asking that question. Because John, kind of touched on it in some of his comments where he talked about the fact that, we're kind of always in discussions, right with companies and that very much is true. So as you know, he mentioned we are in active discussions, kind of at all times, across our portfolio, as we should be, right? That's our business, we partner on the front-end and we create partnership opportunities in the back-end too and everywhere in between to your question. So we do. And it really depends on the program and it depends on kind of the appetite for investment in development. So one of the reasons that we were able to form Daré and we were able to assemble the exciting portfolio that we assembled as quickly as we did and under such attractive terms as we did is because the market right now is fragmented. There's a lot of innovation out there. There as we are doing a lot of opportunities to have first and category products while still leveraging a 505(b)2 pathway, just by being super creative and how you're delivering them for her. So you can really make it more convenient, improve outcomes and that matters and these indications that are not life threatening, but are very much life altering. And there's commercial entities and we've been so excited to watch the news on Organon, and Merck over the last couple of weeks. And there's more nice to see more of that happening. But there hasn't been as much commitment to invest in development in women's health. So Doug, it's definitely something that we are constantly exploring with potential collaborators in the U.S. and outside of the U.S. And when it makes sense for particular program and we think it makes sense for our shareholders, we will absolutely take advantage of this opportunity.

[Douglas Tsao:]

And just as a follow up to that question. I mean, so far, partnership activity has been sort of on a program-by-program basis for your company. And when I look at you, there's certain things that sort of fit in different buckets. And have you ever engaged in multi-product collaboration, partnership discussions, just because I think there's some maybe a little bit earlier stage development that could sort of fit into that bucket?

[Sabrina Martucci Johnson:]

We have all conversations. Absolutely. No, you're absolutely. We explore all kinds of partnering opportunities. And we're very active in that all the time. It's what we need to be doing. And it's what we do. And we're very proud of our portfolio, by the way, I mean, we're able to have those kinds of conversations, because we have in our beliefs, some more like a premier portfolio of women's health development stage asset, so and they are different, like you said, so it does facilitate all kinds of different conversations.

[Operator:]

Thank you. There are no further questions. I will now turn the call back to Ms. Sabrina Martucci Johnson for closing remarks.

[Sabrina Martucci Johnson:]

Well, thank you all for taking the time this afternoon to hear our update and all the great questions and then our chance to share everything that transpired during 2021 in spite of the pandemic and our commitment to our company goals of improving options and outcomes for women and driving value for all of our Daré stakeholders under any operating environment. So we are grateful to our exemplary team, as Lisa mentioned and shareholders support, thankfully, that made our 2020 achievements possible. And as we look ahead, our 2021 plans demonstrate a feature of our business model that is core to its value driving potential. And Doug and his questions kind of touched on that which is namely the variety of our programs and the diversity of our women's health indications and the development stages of our programs. And that really enables us to direct our resources and investment across the portfolio in ways that can advance the programs against numerous milestones simultaneously in a time and capital efficient manner. And so, and we've demonstrated that even in a challenging environment and so we look forward to keeping you updated on our progress against the key 2021 objectives that we discussed today across five of our different clinical stage programs and indications this year. So thank you so much for your time today.

[Operator:]

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.