Q4 2021 Dare Bioscience Inc Earnings Call
Okay.
Welcome to the conference call hosted by Dara Biosciences to review the company's financial results for the year ended December 31st 2021 and to provide a general business update. This call is being recorded my name is Catherine and I'll be your operator today.
With us today are Sabrina Martucci, Johnson, <unk>, President and Chief Executive Officer, John Fair Torres Chief Strategy Officer.
And Lisa Walters Hoffert.
Darren <unk>, Chief Financial Officer, Ms Johnson piece probably seat.
Thank you good afternoon, and welcome to our full year 2021 financial results and business update call for di Bioscience. Our plan today is to review last year's results discuss developments since our last call in November and then use the time to highlight objectives and milestones anticipated for 2022 as well.
There's other insights for the year.
Before we 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 facts should be considered forward looking statements actual results or events could differ materially from those.
As 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 31st 2021, which was filed today I would also like to point out that the content of this call.
Time sensitive information that is current only as of today March 31, 2022, Gary undertakes no.
No obligation to update any forward looking statements to reflect new information or developments. After this call except as required by law.
Yeah.
Darius 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 affected or convenient therapeutic choices, but also for a broad set of stakeholders, including their families partners and of course our shareholders.
Our strategy involves identifying areas of high unmet need.
Selecting promising candidates to address such needs conducting research and development activities in a thoughtful and capital efficient manner and if approved.
Developing an appropriate commercialization strategy for each candidate with the goal of reaching as many potential users as quickly as possible.
With our diverse portfolio, we seek to bring to market differentiated prescription therapies that prioritize women's health and wellbeing expand treatment options and improved outcomes, primarily in the areas of contraception fertility and vaginal and sexual health.
Today, we have seven candidates in various stages of development and one product that has received FDA approval last December .
We're going to spend much of our time today, providing an update on our late stage development candidates and our FDA approved product as it pertains to that FDA approved product that shadow. We look forward to reviewing the announcement, we made today regarding the global license agreement, we entered into with Oregon on to commercialize our shadow which is Clinton.
<unk> and phosphate vaginal gel, 2% are FDA approved treatment for female 12 and older with bacterial vaginosis.
Before we discuss Sochi, Idaho, and our late stage programs such as Evergreen I want to first review the many factors, we consider when evaluating new potential candidates for our portfolio since those factors ultimately impact the commercialization strategies for those products and opportunities to enter into collaboration.
<unk> sections that we have established to date with Oregon, honest, Versace, Idaho and Bayer for over Prime.
Key considerations include the following.
Candidates must have the potential to be a first line or first in category option.
Candidates must represent a meaningful commercial revenue opportunity.
We ideally seek product candidates they use is differentiated and different api's and target different indications or drug delivery modes that are personalized for her and finally, we are particularly fond of candidates that can be developed to be a five O five btu regulatory path or have existing proof of concept, allowing.
US to move quickly to later stages of clinical development and potentially shortening the overall development time and cost to obtain a marketing approval in the U S. As was the case with Zachi auto where we achieved FDA approval Zasyadko just three years after acquiring rights to the program.
Now before we look forward to what is ahead in 2022 I might take a moment to highlight a few important achievements during 2021 since those achievements that is set for where we are today and what is yet to come.
We were awarded a grant for up to $48 9 million over approximately five years to support our preclinical Dare lock one contraceptive program.
The FDA accepted our NDA for <unk>, one, which is now referred to as our shadow and the FCA subsequently approved our application on scheduled <unk> date of December 7th 2021.
We entered into a collaborative research and development agreement or creator under which a pivotal phase III clinical study of over pain will be supported financially by N. I C. H D contraceptive development program and conducted within its contraceptive clinical trial network and we continued our collaboration with Bayer who has.
The commercialization rights for <unk>.
We initiated the phase two B response study evaluating zenithal cream three 6% as a treatment for female sexual arousal disorder. Her version of erectile dysfunction for which there are no current FDA approved treatment.
We initiated a phase one two clinical study of Dare VBA, one our proprietary investigational formulation of tamoxifen for intra vaginal administration to treat vulvar and vaginal atrophy in women with with or at risk for hormone receptor positive breast cancer.
And finally, we generated positive phase one clinical data for D. R. H Archie one our investigational hormone therapy vaginal rain for the treatment of both the vasomotor as well as the vaginal symptoms associated with menopause.
So first now let's talk about bacterial vaginosis, our FDA approved treatments or shadow and our global license agreement with Oregon on to commercialize our shadow.
First the unmet need.
Bacterial vaginosis is the most common vaginal <unk>.
Condition and the most common cause of vaginitis worldwide and is estimated to affect approximately 21 million women in the United States.
The condition results from an overgrowth of bacteria, which upsets the balance of the natural Bachelor microbiome and can lead to symptoms of odor and discharge. Thus shadow received both qualified infectious disease product or Q I D. P and fast track designations from the FDA for the treatment of bacterial vaginosis.
Oregon on shares our commitment to advance critically needed innovation in women's health. We are excited to be collaborating with one of the premier companies in women's health as we believe that organized commercial capabilities will ensure that dash shadow reaches the women most impacted by this condition.
Through Oregon on strong commercial capabilities and expertise in women's health, Oregon on is in a unique position to brings us shadow to market and enable women across the U S to access this important option.
Under the terms of the agreement, we will receive a $10 million upfront payment from organized we're eligible to receive potential milestone payments of up to $182 5 million and tiered double digit royalties based on net sales.
Dodge Shadow is expected to be available commercially in the U S. In the fourth quarter of this year.
Completion of the transaction is subject to review under the Hart, Scott Rodino Antitrust improvement Act and other customary conditions and the transaction is expected to close in the second quarter of 2022.
I will shortly turn the call over to John to share some additional insights regarding our collaboration strategy and objectives in selecting Oregon on as our commercialization collaborator for Saatchi, Idaho, but before doing so I'll briefly provide updates on certain of the development milestones and objectives. This year for our other programs.
Over training is our potential first in category option in the over $7 billion contraceptive category. It is our novel hormone free monthly contraceptive candidate, whose U S. Commercial rights are under a license agreement with Bayer in.
In the third quarter of 2021, we announced the credo that I mentioned with the units Kennedy Shriver Natural National Institute of child Health and human development or in a C. H D, which is part of the NIH the national Institutes of health for our pivotal phase III study of evergreen the crate out reflects the N. I C. H D is continued support for the development of Evercore.
And will allow us to leverage the tremendous development expertise of the NIH in contraceptive clinical studies and to share the cost of the pivotal phase III study with the NIH.
So that next stage of clinical development for overprint is that pivotal phase III contraceptive study that we will be conducting with them.
In order to initiate the pivotal phase III study, we must have an FDA approved IV eight I E in place and so we initiated that process froze a prime early this year and pending the Fda's review and approval of the IDE E. We seek to initiate the pivotal study this year.
Under the license with Bayer Dara received access to Barry's extensive clinical and market expertise through on up to approximately 80 hours per week and advisory support while retaining control over evergreens development and regulatory approval process.
Bayer has the right to obtain exclusive rights to commercialize the product in the U S. Following completion of the pivotal trial. The one that is being planned to be undertaken by Dorian the N I C. H D by making to Daria 20 million dollar payment.
We will also be entitled to receive commercial milestone payments potentially totaling $310 million. In addition to double digit tiered royalties on net sales.
So Dennis L. Crane is our investigational product to address her version of erectile dysfunction as I mentioned in March of last year, we commenced our phase <unk> study evaluating sildenafil cream three 6%, our investigational cream formulation of Sildenafil, which as you know is the active ingredient in viagra.
For topical administration to treat female sexual arousal disorder FSA D S.
FSA D is a physiological condition characterized by the inability to attain or maintain sufficient general arousal during sexual activity sounds familiar of the various types of female sexual dysfunction disorders. It is the most analogous to erectile dysfunction in men and yet there is no FDA approved product that.
Exist today to treat FSA D.
If our clinical development is successful so Dennis cream has the potential to be the first FDA approved FSA D treatment option.
We continued to enroll women in the phase <unk> respond clinical study evaluating <unk> cream as a potential treatment for FSA D. At sites located across the United States. Our study protocol does have a planned interim analysis is to evaluate the power calculations and trial sizing. So once we.
Conduct that analysis, which is planned this year, we will provide guidance on anticipated timing for the top line data.
Nextera HRT one the.
The results of the completed phase one study of our investigational hormone therapy product or Dare HRT won last year demonstrated its potential as an effective hormone therapy for both the visa motor and the vaginal symptoms associated with menopause.
Dear H O T. One is a unique vaginal ring, it's designed to deliver bio identical estradiol and bio identical progesterone together continuously over a 28 day period as part of a hormone therapy regimen.
As the next step in the development program. We are now commencing a phase one two clinical study of Dare I T. H O T. One in Australia in the second quarter of this year. This open label study will evaluate the PK of the lower end high dose versions that we had studied previously of der HRT one in approximately 20.
Healthy post menopausal women over now approximately three consecutive months of use the study will also collect safety usability acceptability and symptom relief data.
There are currently no FDA approved IV ours that deliver bioidentical progesterone in combination with bio identical estradiol as such Dare HR T. One has the potential to be a first in category product that offers monthly convenience for women.
And the last portfolio candidate I will discuss today is dare BVA one.
More than $3 8 million women in the U S have a history of breast cancer.
Hormone receptor positive is the most common type of breast cancer and the prevalence of Baldwin and vaginal atrophy in postmenopausal breast cancer survivor is estimated to be 40% to 70%.
We would like to provide an option to those women.
<unk> BVA one is our proprietary investigational formulation of tamoxifen for vaginal administration to treat DVA.
As a non hormonal approach to addressing vaginal atrophy it could be an important option for women with a history of or at risk for hormone receptor positive breast cancer.
VA is often also the outcome of effective breast cancer treatments and as I mentioned, it can lead to vaginal comfort, including painful intercourse, which as you can imagine causes significant distress for many women an appropriate treatment for vaginal atrophy, a supplemental estrogen however, estrogen may pose a risk to women at risk for home.
Receptor positive breast cancer, and hence their BVA one may offer a solution for these women and others for whom hormonal treatment is not an option.
As I mentioned in my opening remarks, we initiated that phase one two clinical study in Australia in the third quarter of last year for what we referred to as this breast cancer survivorship vaginal extra tree treatment program Dear BVA, one and we expect to report topline data from the Derby day, one phase one two study during the second half of this year.
Now you've been waiting to hear more about Zasyadko I'm going to turn the call over to John to provide our perspective on commercialization and collaboration strategies in women's health. Thank.
Thank you Sabrina as Sabrina noted at the start of the call. We closed 2021 by achieving a number of important milestones for Dara chief among them was the FDA approvals or shadow in December of 2021, as we communicated on our last call. We are a company focused on providing better therapeutic options for women and collaborations are core to our business model and the contract.
Zasyadko our objective was to identify the right commercial collaborator for the product specifically, one with strong commercial capabilities and expertise in women's health that would be in a unique position to bring zasyadko to market and leverage the clinical outcomes achieved in the phase III clinical study.
Josh Your auto uses a novel thermosetting gel formulation containing clindamycin at a concentration of 2% present as clindamycin phosphate.
With onetime dosing in the phase III trial, Zasyadko demonstrated clinical cure rate of 70% at the test of cure visit the day 21 of 30 visit as compared to 36% for placebo the.
The potential to offer women, a new option for treating bacterial vaginosis enabled us to engage with the most capable potential partners in the women's health landscape and we are excited that organon will be leveraging its strong commercial capabilities and expertise in women's health two brings our shadow to market organize goal to deliver innovation.
To improve access and expand choice to help address therapeutic gaps in women's health is clearly aligned with our mission and what we wanted to accomplish with Zasyadko.
Transitioning to overprint are overpaying collaboration with Bayer has remained focused on activities to support the IV process with the FDA, including manufacturing activities and importantly, pre commercialization activities that informed the design of the pivotal study targeted to commence later this year and ultimately the launch strategy for this potential first in cat.
<unk> contraceptive candidate we are fortunate to work with collaborators that share our vision to deliver innovation in women's health and have the access and expertise and sales capabilities to enhance our impact I will now turn the call over to Lisa who will give you a financial update.
Thank you John and thanks to all of you for joining US today I would now like to summarize <unk> financial results for the year ended December 31, 2021, which I will refer to as fiscal 'twenty, 'twenty, one or 'twenty or 'twenty one.
<unk> 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 or R&D activities.
While they're generally administrative expenses tend to be somewhat predictable throughout the year. Our R&D expenses will vary with our clinical preclinical and manufacturing regulatory and other activities related to advancing our portfolio of candidates for fiscal 2021 dairies G&A expenses were approximately $8 4 million.
And our R&D expenses were approximately $30 $6 million.
And the $9 8 million dollar increase in R&D in <unk> in 2021, compared with 2020 is primarily attributable to the cost of the ongoing soft vehicle cream phase <unk> respond clinical trial for female sexual arousal disorder manufacturing and regulatory affairs activities related to overseeing and develop.
<unk> activities for our phase, one and phase one ready program, our comprehensive loss for the year was approximately $38 8 million.
During fiscal 2021 net cash proceeds from financing activities were approximately $75 $8 million and primarily reflected sales of stock under our ATM program. We ended 2021 with approximately $51 $7 million in cash and cash equivalents.
To take a moment to highlight two interesting financing developments that occurred during 2021.
In June we entered into an at grant agreement, making us eligible to receive up to $48 $9 million to support the preclinical development of Gairloch one of roughly the next five years. We received an initial payment of $11 $5 million in July and any future payments will be contingent upon <unk> one.
The program, achieving specified development and reporting milestones.
At year end December 31, 2021, approximately $10 5 million was recorded as a deferred grant funding liability under this grant agreement in our balance sheet.
We are truly grateful to have been selected for a grant of this magnitude that covers multiple years of development work to advance this truly innovative technology.
Second in July as Sabrina I had mentioned we entered into the cooperative research and development agreement or creator with Ni CH D for the conduct of the phase III study of overprint.
Gerry agreed to contribute $5 5 million towards the total estimated cost of the pivotal study and we paid about $5 million to date, Jerry will also be responsible for providing the clinical supplies of overpaying for this study for each part and I C. H D will be responsible for the other costs related to the contracted the pivotal.
Pivotal study and we will manage the payment of expenses to third parties.
We truly believe ni Chd's contraceptive trial experience and financial support should elaborate that completion of the overprint pivotal study in an efficient and cost effective manner.
In terms of developments during the first quarter of 2022, as Sabrina and Jon just discussed we were thrilled to announce a global license agreement with the Oregon on for the commercialization of Zasyadko.
Again, Jerry will receive a $10 million upfront payment from from Oregon, and Jerry will be eligible to receive potential future milestones of up to 182, and a half million dollars as well as tiered double digit royalties based on net sales.
Now she Yahoo is expected to be available commercially in the U S. In the fourth quarter of 2022.
Completion of the transaction.
Is subject to the review under Hart, Scott Rodino Antitrust improvement Act and other customary closing conditions.
The transaction is however expected to close in the second quarter of 2022.
As of March 32022, dairy had approximately $83 9 million shares of common stock outstanding.
So in closing, we will endeavor to be creative collaborative and opportunistic in seeking the capital that we need to advance our category, our candidates and build shareholder value.
As Sabrina had noted at the beginning of the call. We encourage investors to review the more detailed discussion of our financials and financial condition, our liquidity and capital resources and our risk factors in our annual report on Form 10-K for the year ended December 31, 2021 that was filed today.
I would now like to turn the call over to the operator.
Thank you to ask a question you will need to press star one on your telephone to withdraw your question press. The pound key again, if you would like to ask a question press Star one.
First question comes from Sigma Gela with Roth Capital Partners. Your line is open.
Hello, Thanks for taking my questions and congrats on the progress as well as the recently signed a deal with them again and I think everything looks like it's on track. So I'm just going to ask questions. There are a lot of folks have been wondering I think the first is just about your decision to have again only people.
But the commercialization as opposed to partnering with them on the commercialization and then also you know your decision around perhaps given them right of first negotiation to some specified products.
Yeah, great great questions and thank you for asking about.
About Oregon on and the decision.
So first of all just taking a step back it's always wonderful when you have developed a product and you have a vision right of selecting product product candidates that truly address persistent unmet needs.
That therefore have an opportunity to be first line or first in category and they have meaningful commercial potential that they should be partner bowl to actually when you get to the finish line of an FDA approval you now have.
Interest right from from parties in that product candidate that product candidate.
And really what that does is provide a lot of optionality and as we have talked about prior to today and being able to disclose them.
<unk> selected partner for this program, we certainly right looked at a variety of different structures and options and Fortunately, we're in a position where those were possibilities and opportunities including opportunities to co promote.
However, as we've also said several times, we really tried to be disciplined and look at each product on its individual basis and merits and really also tried to be very very focused on what is the best way to ensure that product has the access to the most women as quickly as possible because.
What that does is it maximizes access that's good socially that's good for women. That's also good financially and it can also impact your time to peak sales. So we really tried to look at it from that perspective, and clearly clearly I think right entering into a partnership collaborating collaborating with one of the.
The premier companies in women's health as we believe that organon is obviously and with their commercial capabilities will ensure that Saatchi art overreaches. The most impacted women from this condition.
As quickly as possible and so you know while we'd love to think that Dara can add a lot of value commercially.
I think that you.
You know, it's very clear that obviously, an organization like organ on with their global footprint and with their strong strong commitment in women's health and they are they're very very.
The mission that is so unified with what our mission is clearly a great partner for this program and am.
Best for Dara to to do what we do well and continue innovating and that is a great transition to your question right about what.
You noted in the transaction, which it does.
<unk>.
Clued in opportunity right for organ on to have exclusive worldwide rights of first negotiation for specified potential future diary products.
And you know.
I think that's just representative of the kind of work that DRA does organize commitment to the category our commitment to <unk>.
Continuing to enhance and build our portfolio again with products that address persistent unmet need that have a potential to be first line or first in category products and have the potential to address.
And really be meaningful commercial opportunities and so that's really what that that represents it's our alignment and our vision of the kind of work they are going to be doing and that we want to be doing and it really just gives.
An opportunity for for us to chat.
And talk about those potential future products.
Okay.
Thank you Sabrina and then I just have two quick ones and I'll get back in the queue at the first one yes, just about the broad reach of again and so I imagine.
The ex U S opportunity is important and so just kind of wanted to get some commentary around what that market opportunity could be sensors camera, we've been talking about the U S market and then how quickly you know.
The leverage in terms of the market.
Yeah, so definitely so.
They are a global organization right. So they have that they have that global footprint.
You know in terms of the focus right now obviously, we have the U S approval. So that is clearly a focus and I think growth outside of the U S. As an ongoing consideration.
You know Theres no confirm plans that we're going to talk about right now, but obviously it is a global transaction women around the world experienced bacterial vaginosis, it's not focused in the U S. But the current approval today is in the United States. So obviously, that's that's a clear priority right now.
Thanks, Good for modeling and then the last thing is just about.
Some clarification for overprint I know after the idea it is blue.
You can move into a phase three study, but was just wondering if there was anything that we need to know that can kind of take place between the I D approval and when you can start the phase III. Just so we can kind of guesstimate as to when that piece.
Overprint can get underway.
Yeah. That's it that's a great question and I'll try to provide as much clarity as I can but basically as I mentioned, we have initiated the process with the FDA, which really allows us to have that collaborative discussion around.
The IGD and the clearance of the ITE and importantly.
The reasons that we started obviously that process is really so that we can make sure that we are aligned on the protocol for the pivotal study because it really one of the longest lead time items when you're preparing for a for a trial of any kind is that pivotal study protocol. The design of the study and because overtreated.
Is so unique as a development candidate in the contraceptive category. It's the first product that has the potential to be the first monthly hormone free vaginal contraceptive method, having an understanding of some of those requirements is really one of the important steps because there's work that we have to do along with the NIH to prepare for that pivotal study.
So that we can initiate this year so by starting those discussions with the FDA, we do have an understanding.
Of the.
Key pivotal study requirements 200, women completing 12 months and.
That really allows us to do the work to prepare from a manufacturing perspective.
To prepare product supply to support the studying to prepare and site selection and all of that work and then from an FDA perspective, it's really just completing the IDE process and obviously as we.
Have have updates on that we'll provide them, but right now we're really working towards this this big picture right, which is this year and importantly got some great clarification on the protocol, but it's allowing us to start some of those planning activities.
Thanks, and congrats again on the partnership.
Thank you. Thank you so much.
Thank you and as a reminder, if you would like to ask a question press. The Star then the one key on your Touchtone telephone.
And our next question comes from Douglas Tsao with H C. Wainwright Your line is open.
Hi, Thanks for taking the questions.
That's on the deal just as a starting point Sabrina you've obviously.
<unk> successfully partner Josh.
And as well as all the premium what's drove the premier.
Women's health organizations in the World just curious how are you now thinking about the.
Pipeline and at what point is it right for you to become a commercial organization and begin to build out that capability.
Well. Thank you for the question. So first of all thank you for recognizing.
You know what we've achieved to date right in terms of.
Partnering with them and we're not just saying it because there are partners, but partnering with organizations like Bayer and Oregon on.
You know that they have.
Really prioritized right women's health, that's important to us to partner with organizations.
When we partner for commercialization that are truly aligned and have the kind of capability as John mentioned right capability around access capability around commercial sales infrastructure to ensure that the women impacted most by the conditions are really going to have an opportunity to be served.
Like I said, so so that's definitely critical and and as we think about commercialization strategy right Big picture.
One right, we always want to do the best thing for that product and how do we achieve that for that product and two to your question of you know.
Question, we have a whole portfolio of women's health products right I talked about we have seven other programs in development.
And I only talked about a few of them today. So.
At what point might it become interesting fujairah to participate obviously, we have a portfolio to support it right off and that's the challenge right you might have one approved product and what do you do next we clearly have a portfolio to support it and that gives us true optionality and at some point where products start to.
Have approvals that are becoming more aligned right from a timing perspective, such that one would not be in a position with one individual product, where you're trying to build all that infrastructure in and be successful around one product. It can start to become more interesting having said that if we continue to.
River the way we have to date on these first furthest along these two furthest along programs to develop products that truly address a persistent unmet need that have that first line or first in category opportunity that have that kind of commercial potential that is what truly is going to mean, we have real optionality, where we can.
<unk> partner, if it makes sense to partner and collaborate in the way we have with these two collaborations that we've already done with with organized and Bayer or.
Participate at some level and commercialization, if we if and when we make a decision to participate it will be because we believe that we can add value to.
To the brand and importantly to our shareholders by doing so right to our shareholders by doing so because ultimately you build value when you're launching a product.
Like I said fundamentally by making sure that it's getting too all of the women who need it as quickly as it can and in the most efficient way possible and to date, we strongly believe that through these partnerships that we've entered into these collaborations that we have entered into with organizations that have that clear capacity and.
Have demonstrated importantly demonstrated success in building very important.
And very commercially successful brands.
In women's health specifically.
Yeah.
So hopefully that answers.
No no no that's really helpful and just as a quick follow up on the Das Seattle deal with Oregon on specifically.
It's a global deal or any of the milestone payments tied to ex U S commercialization.
Yeah, Great Great question.
Really what we disclose right about the transaction is the big picture right on the milestones that are forthcoming so.
Obviously, there is the $10 million.
Sure.
It is really the upfront consideration and then there's a two and a half million at first commercial sale and and then Theres a $180 million.
In additional milestone payments and of course, that's on top of the double digit tiered royalties in that $180 million. The clarity that I can give you on that its tiered commercial sales milestones and regulatory milestones.
Okay.
Great. Thank you very much.
Yes. Thank you.
Thank you and our next question comes from Kumar, Russia with Brookline Capital. Your line is open.
Thanks for taking my questions and I will also add my congratulations for the partnership.
So with regard to <unk>.
With regard to that.
Seattle.
<unk>.
Where are you in terms of manufacturing and how is it going to work these Oregon I'm going to take over.
All of that.
Yeah, Great Great question. So as you know as we had guided previously.
In terms of supply we are.
In the supply chain.
Working on supply and we have guided previously that because of supply chain. The earliest that commercial supply was anticipated to be available is summer of this year.
And that really ties into obviously the.
You know the anticipated right timing around the.
The commercial launch that we've been talking about right, which is that we expect it to be commercially available in the fourth quarter. So that really ties into that in terms of your question on well who's doing that how does that work under the agreement we're going to be responsible for a couple of things actually regulatory interactions and.
For providing that product supply.
On an interim basis really until organon assumed those responsibilities so until that time that Oregon on resumed assumed those responsibilities, which is the intent until that time, they would purchase all of the product supply basically requirements zasyadko from us.
And we would oversee that manufacturing activity.
And it's with you know and obviously, we've been doing that already.
As we won they've been preparing for launch, but obviously for all of the clinical supply that supported the successful phase III study.
Okay. So I assume there would be like a little bit mark up compared to what how what it's going to cost you guys. Yeah. So basically there is a transfer price, which would be equal to our manufacturing costs plus a single digit percentage markup.
Okay and also you said a timeline when you switch company toward all going on.
Yeah, that's not really something that we're discussing yet, but that's the intent right that over time that these are responsibilities that they would take over when it makes sense.
Okay.
Obviously, we had these processes underway and we're all working towards right.
An opportunity of potential to launch this year and obviously this is a nice efficient way to get there.
Okay.
Got the or paying you touched on it a little bit with regard to the IV.
So where are you in the process with regard to the interactions like.
Now that you can share like especially bad you at how long could it take to get the clearance.
Yeah.
Really no more color than what I've shared to date other than you know.
We started that process in earlier this year right at the beginning of this year.
With the IDE submission, which we converted to a pre submission and that really allows us to have a collaborative discussion.
That isn't as time limited around things such as the pivotal protocol.
We very importantly wanted to have an opportunity to have comp.
Conversations around as I mentioned in my comments and John also alluded to in his comments.
One is what is the behind the comment was one of the reasons right to partner with with Bayer to collaborate with Bayer when we did on the Evergreen program right before the pivotal study is to get.
All of those bears input for a product like <unk> that is.
So different from other contraceptive products has such a product candidate opportunity to be unique in the category. We wanted to make sure that we got a lot of commercialization insights from Bayer that could translate into things. We wanted to do in the pivotal study to really ensure the product is best situated for success and so as we view the I D E.
Process, we really wanted to make sure we had an opportunity in the process to engage and interact with the FDA on certainly addressing any other questions. They have right about overpaying because it is unique but importantly also to have an opportunity to engage with them.
In a more collaborative dialogue process. So that we can make sure that for instance, things that Bayer has learned about the marketplace and that we want to incorporate in the pivotal study to ensure that it is really positioned now.
Isaly for commercial success that we could do that.
And so we.
We have initiated that process, but because of how we're running the process and collaborating with the FDA and the process I can't give you.
And date.
The process other than to say the whole process is geared towards allowing us to get into the clinic. This year, which is the objective right to get into the clinical study this year and similarly, that's what we've been working on with the NIH in terms of all the preparatory activities and based on a lot of the feedback that we've already received that's really allowed us to start.
Planning with the NIH.
Around.
You know sites activities things like that so that we can be ready and importantly, knowing you know that we need to be looking at 200 women completing 12 months of use that helps us considerably and planning while we're working to other things. So I know I gave you a very long answer that didn't.
I'll give you an exact timeline I can't I can't do that quite yet, but hopefully.
Now it makes it a little more sense of why we're in the process. We are with the FCA on the ITE and that overall, what we're working towards is that pivotal studies start this year and there's a lot of activity underway to support that yet.
Yeah, that's very helpful. So basically the understanding is that.
It's going to be a seamless process once the resubmission is gone what we accomplished submission they have about 30 banks expectation, yes, okay.
Thank you, yes, thank you for saying that yes.
Thanks, so much congratulations again.
Thank you. Thank you.
Thank you and I'm showing no further questions in the queue I'd like to turn the call back to Sabrina for closing remarks.
Great well. Thank you all for taking the time this afternoon to hear about a recent updates then.
Our ongoing commitment to really drive value for all of our stakeholders women healthcare providers and our shareholders and you know in closing trade money one for the year as very meaningful developments for Dara and really positioned us for a strong first quarter in 2022.
And we absolutely look forward to keeping you updated on our progress against the important 'twenty, two objectives and milestones including activities over the next several months with the Oregon on regarding Saar Shadow preparations that we just talked about for the evergreen phase III study with the NIH and Bayer and our ongoing CIT NFL cream phase <unk> studies.
For female sexual arousal disorder. Her version of erectile dysfunction. So thank you all so much for taking the time. Thank you for supporting our work and thank you for for really being aligned with our ongoing commitment to drive value for all of our stakeholders.
Do you.
This concludes today's conference call. Thank you for participating you may now disconnect.
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Yes.
Yes.
Yeah.