Q3 2022 Dare Bioscience Inc Earnings Call
Welcome to the conference call hosted by John Reed Bioscience to review the company's financial results for the quarter ended September 30th 2022.
And to provide a general business update.
Call is being recorded.
My name is Paula and I'll be your operator today.
With us today are Sabrina Martucci, Johnson, <unk>, President and Chief Executive Officer, John Fair Die as Chief Strategy Officer, and Lisa Walters Hoffert Durie, Chief Financial Officer MS. Johnson. Please proceed.
Thank you good afternoon, and welcome to our third quarter of 2022 financial results and business update call for dairy Bioscience. Our plan today is to review our third quarter results discuss developments since our last call in August and use the time to review our business strategy, including y.
We believe investment in women's health is efficient and disproportionately impactful and to highlight some important objectives and milestones anticipated through the end of the year end in 2023.
Before we begin I would 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 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 31st 2022, and our quarterly report on Form 10-Q for the quarter ended September 30th.
'twenty two.
Which was filed today.
I would also like to point out that the content of this call includes time sensitive information that is current only as of today November 10th 2022.
CRA 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 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 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 and 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 then 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.
Specifically, we signed these statistics that I'm about to share about innovation in women's health compelling.
Approximately only 1% of health care research is invested in female specific conditions beyond oncology.
And women's health conditions outside of oncology comprised less than 2% of the.
Health care pipeline.
Yet women's health products outside of oncology make up 27% of the total number of blockbuster products products that each have over 500 million in annual sales.
And women's health products contribute 35% of the total sales dollars generated by blockbuster products.
So think about that for a moment a therapeutic category that received less than 2% of health care research investment is contributing 35% of the revenue generated by blockbuster brands.
This is why we believe investment in women's health will be efficient and disproportionately impactful in terms of translating dollars invested in R&D to ultimate revenue generated.
And is therefore, not only good for the 50% of the population to whom these products are targeted and who by the way control, 80% of U S health care purchasing decisions, but it's also a good business model.
As a reminder, Darius portfolio that is focused solely and squarely on women's health is built upon the following core principles one each product candidate must target a meaningful market opportunity.
To each product candidate much have first line or first in category potential because.
Because we seek to offer meaningful not incremental improvement.
And three our goal is a diversified mix of candidates that can be developed efficiently in terms of time and capital and he was regulatory pathways, often leverage well known and well characterized active pharmaceutical ingredients or API.
Specifically in addition to our FDA approved product for bacterial Vaginosis, a condition estimated to affect approximately 21 million women in the U S.
What are our big ideas in women's health.
Well, it's the four novel contraceptive candidates or potential candidates in our portfolio.
First hormone free monthly contraceptive candidate <unk> first six or 12 month injectable that we call a day or two or four to one for first long acting reversible contract perceptive system, Denmark, one and a hormone free contraceptive target for women and men deer, our H one.
It's the three vaginal health product candidates or potential candidates in our portfolio, specifically Deere HRT won the first hormone therapy estradiol, plus progesterone monthly Intervet general range.
<unk> BVA one the first hormone free vaginal atrophy therapy for women with hormone receptor positive breast cancer.
And glycerol motto laureate, a naturally occurring fatty acid monoester that has shown broad antimicrobial activity and that may be developed to potentially treat under prevent vaginal infections in various sources.
It's our sexual health product candidate in our portfolio. The first topical cream with the same active ingredient as viagra being evaluated as a potential first in category treatment for female sexual arousal disorder FSA D.
And it's our pregnancy maintenance and management product candidates in our portfolio <unk> and <unk>. The first interim vaginal ring designed to release Bioidentical progesterone over 14 days.
We continue to drive our portfolio forward to deliver value as evidenced by the milestone C achieved just in the last few months and the milestones expected by the end of 2022 and into 2023.
Josh Shadow clindamycin phosphate vaginal gel, 2% for bacterial Vaginosis sascha.
Shadows, only <unk> antibacterial for a single dose vaginal administration indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older.
Bacterial vaginosis is the most common vaginal condition in women of reproductive age.
This marks the first FDA approved product from dairies portfolio, a potential first line or first in category development candidates our commercialization collaborator is organized.
And we are thrilled that commercial launch preparation activities have begun and are ongoing the Oregon on market access team is meeting with customers now to reviews, our shadow and obtain competitive coverage and the bacterial vaginosis marketplace.
Oregon on will leverage its established nexplanon sales team to accelerate <unk> uptake at launch.
Oregon on believes there is roughly a 90% overlap of those health care providers, who prescribe nexplanon and who diagnose and treat bacterial vaginosis. The strong relationship. The sales team has with these providers are expected to enable immediate access as early as day one.
And the first commercial sale as anticipated in the first half of 2023 in the U S.
Over training or hormone free monthly birth control candidate <unk>, an investigational potential first in category hormone free monthly <unk> contraceptive, our commercialization collaborator as Baer and our pivotal study collaborator is the NIH.
We announced the idea approval by the FDA in October for our planned pivotal study and we are currently reviewing and implementing additional FDA design recommendations in order for this study to serve as the primary clinical support for our future pre market approval submission to the FDA in other words if successful we.
Spec this study to be the single pivotal study necessary to support a PMA submission to the FDA.
The NIH is holding an investigator meeting with the <unk> investigators in December of this year 2022, and we anticipate initiating recruitment mid 2023, we will target about 200 subjects, completing 12 months or 13 cycles of use.
So that is so cream are female sexual arousal disorder product candidate. So the NFL cream is an investigational potential first in category treatment for female sexual arousal disorder, FSA D, which has no FDA approved therapies.
It's a novel cream formulation of Sudan, NFL, the same active ingredient as invite high growth.
Subject screening for the exploratory phase to be response study was completed in October approximately 160 to 170 subjects. In total are expected to complete the clinical study and approximately 100 subjects have completed all study assessments to date topline data announcement is currently targeted for the second quarter.
A 2023.
Derek <unk>, our hormone therapy for the treatment of menopause symptoms. It has the potential to be a first in category convenient combination hormone delivery product for the treatment of visa motor in vaginal symptoms of menopause.
<unk> is an investigational intra vaginal ring designed to release Bioidentical estradiol and Bioidentical progesterone over 28 days.
It has the potential to be the first monthly format product with both hormones. There are no FDA approved options with both hormones in one monthly international rain.
Last month, we announced topline data from our phase one two study in approximately 20 healthy postmenopausal women. The primary objective of this study was to describe the safety tolerability and pharmacokinetics or PK of two different dose combinations over 12 weeks of use.
Secondary objectives were to assess that usability, new participant tolerability and preliminary effectiveness for both surveys of motor symptoms, where BMS and the vaginal symptoms of menopause.
Despite the small sample size, we were very pleased to announce that the levels of estradiol release from both the lower.
And higher dose formulation of Dare <unk> evaluated in the study achieved statistically significant improvements compared to baseline in the visa motor as well as the general urinary symptoms of menopause vaginal ph and maturation index all at the P less than 0.1 level.
<unk> had a higher level of acceptability in this study with 100% of the subjects reporting that the <unk> was comfortable to wear and over 95% of the subject, stating they would be either somewhat or very likely to use the ABR for our women's health condition or even unrelated disease if needed.
We look forward to topline PK data from this study later this quarter.
So why are the findings from this study important well the data support the potential of dare <unk> to deliver effective hormone therapy in a 28 day <unk> rate.
The delivery of hormone therapy over 28 consecutive days with no daily intervention support dare <unk> potential to be a first in category option offering ease of use and consistent dosing to women suffering from menopausal symptoms.
There are currently no FDA approved non daily products that continuously deliver hormone therapy with both estradiol and progesterone together over multiple consecutive weeks.
And their BVA, one our vaginal atrophy treatment candidate for women with breast cancer.
Dara BVA one has the potential to be a first in category hormone free vaginal treatment for vulvar and vaginal atrophy or BVA.
In a hormone receptor positive breast cancer patient population.
<unk> is an investigational proprietary formulation of tamoxifen for vaginal administration.
It has the potential to be the first therapeutic specifically approved for treatment of agile atrophy in patients with hormone receptor positive breast cancer.
There are currently no FDA approved products labeled for vaginal atrophy treatment in hormone receptor positive breast cancer population.
Globally breast cancer is the most frequently diagnosed cancer type accounting for over 2 million cases each year.
And approximately 4 million women in the United States have a history of invasive breast cancer.
And of all breast cancer diagnosis in the U S. Women, it's estimated that more than 68% are hormone receptor positive.
Vaginal atrophy prevalence in post menopausal breast cancer survivors is estimated at 42% to 70%.
There's a clear unmet medical need for an effective non hormonal treatment for vaginal atrophy caused by anti cancer endocrine therapy in patients diagnosed with hormone receptor positive breast cancer.
Historically estrogen based therapies delivered through creams rings, and vaginal suppository had been prescribed for the treatment of vaginal atrophy symptoms. However, the use of these estrogen based products for the treatment of agile atrophy in hormone receptor positive breast cancer patients can be challenging for both healthcare providers and their patients as they use.
Of estrogen in any form is often country indicated for this patient population.
If we are successful they're BVA one has the potential to become a new standard of care as the first and only vaginally administered product approved for the treatment of Agila atrophy in a hormone receptor positive breast cancer population. We are on track to announce the phase one two study top line data before the end of this year.
Here.
I will now turn the call over to John to provide an overview of the two commercialization collaboration agreements we have in place for <unk> and <unk> respectively.
Thank you Sabrina given the stage of our current portfolio and the market dynamics in the therapeutic categories specific <unk> and <unk>, we believe the best way to generate value for <unk> shareholders, while external commercial commercialization collaborations or out license agreements rather than having to commercialize these assets on our own.
Opportunities to enter into such collaborations are ultimately contingent upon developing differentiated products that demonstrate the potential to be first line or first in category.
Let me begin first with bacterial Vaginosis and our first FDA approved products as our shadow working on our global collaborative as our shadow shares our commitment to advance, particularly the innovations in women's health and we believe that organize unique focus on women's health, coupled with our strong commercial capabilities will ensure that Josh your outer reaches women most impacted by this condition.
We believe that organ on is uniquely positioned to bring <unk> to market and will drive patient and provider awareness ultimately use zasyadko based on Josh that is unique and differentiated product profile and Sabrina mentioned organon will leverage the established nexplanon sales team to accelerate as all shadows uptake at launch we're going to I believe this is a.
Roughly a 90% overlap of those health care providers, who currently prescribe and Exelon are also diagnosing and treating bacterial vaginosis.
These strong relationships at an excellent sales team.
Develops we will help us in the providers and expect that we able to get access to these providers as early as day one of the launch.
Under our license agreement was organon that allows them to commercialize zasyadko, we received a $10 million cash payment from Oregon on after the license became effective in June and we're also eligible to receive potential milestone payments of up to $182 5 million as well as tiered double digit royalties based on net sales.
Launch activities are ongoing in the current quarter Zasyadko is expected to be available commercially in the U S. In the first half of 2023, let me transition now to the commercial activities underway for overcame our novel hormone free monthly <unk> contraceptive candidate who is U S. Commercial rights are under a license agreement was there as a reminder, as part of our license agreement.
With Barrick to commercialize over Green Dara has access to <unk> extensive clinical manufacturing and commercialization resources in an advisory capacity for approximately eight hours per week, while we retain full control over development and regulatory approval process. There has the ratio obtained exclusive rights to commercialize <unk> in the U S. Following <unk>.
On the physical pivotal phase III study.
A $20 million payment to Dara.
Our after dore will be entitled to receive commercial milestone payments potentially totaling $310 million. In addition to double digit tiered royalties on net sales as we've mentioned before opening is a distinct and novel contraceptive candidate. There is no predicate device for <unk>, meaning there is no existing FDA approved product that the FDA can use as reference to.
Compare with Oaktree and bear has proactively initiated pre commercialization activities, including discussions with Payors providers and women. The commercial team is uniquely focused on identifying key drivers and points of differentiation that will resonate with payers and providers and patients. There is a unique leadership position the hormone and hormel.
Category.
With their marine franchise, and Theyre looking to establish a similar leadership position in the non hormonal category with overprint as we've mentioned they are actively engaging payers and providers to gain meaningful insights into the best way to position <unk> to maximize market uptake and are simultaneously collaborating with DRA by providing input into the phase III study.
Designed to reflect these important commercial insight.
So I'll now turn the call over to Lisa to provide a financial update.
Thank you John and thanks, everyone for joining us today I would now like to summarized <unk> financial results for the quarter ended September 32022, which I'll refer to as the current quarter or the third quarter of 2022.
<unk> business model is comprised of two parts. The first is to assemble and advance our portfolio of differentiated product candidates that address meaningful unmet unmet needs that we've identified in women's health. The investment required to do this includes corporate overhead portfolio acquisition and maintenance costs and ongoing research.
And development or R&D expenses.
The second part of our model involves monetizing the value of our portfolio of clinical and regulatory advances over the near and the longer term. There are many ways to generate value from products with differentiated outcomes and one approach includes securing payments upfront and over time in the form of license fees commercial.
While stones and royalties on net sales.
For our first FDA approved product Zachi auto we recognized $10 million of revenue during the second quarter from an upfront license fee under our global license agreement for <unk> with organized and the $10 million cash payment was received in the current where third quarter as my colleagues, both mentioned DRA will be entitled to receive.
Potential additional milestones and royalties one Saatchi art it was commercially launched the.
But back to our current quarter.
During the third quarter of 2022, our general and administrative or G&A expenses were approximately $2 $7 million or R&D expenses, which vary from quarter to quarter based on clinical and preclinical manufacturing regulatory and other activities were approximately $4 5 million and primarily <unk>.
<unk> the cost of the ongoing Sildenafil cream, three 6% phase <unk> respond clinical trials and the manufacturing and regulatory activities related to <unk>, our comprehensive loss for the quarter was approximately $7 3 million.
We ended the current quarter with approximately $44 million in cash and cash equivalents.
During the quarter, we received $18 million in cash, which includes the $10 million license fee from Oregon on that I. Just mentioned that was recognized as revenue in the second quarter and a cash disbursement of approximately $8 million under our existing grant to fund the <unk> one program.
Now during our quarterly calls we've highlighted the importance of non dilutive sources of funding to our strategy in.
In addition to grant funding, we've noted that under Australia's current R&D tax rebate program certain clinical study expenses incurred in Australia are eligible for partial reimbursement, which is currently up to 43% of such expenses.
In October of this year 2022, we received an R&D cash rebate of approximately $786000 for clinical work performed in Australia. During 2021, the rebate will be accounted for as an offset to our research and development expenses.
Our creative with the NIH allows starting to share the cost of the <unk> pivotal study with the NIH and to also tap the NIH has extensive experience in conducting contraceptive studies.
Our share of the expenses under the creator involve providing clinical supplies of overpaying coordinating interactions with the FDA preparing and submitting supportive regulatory documentation and providing $5 5 million TV and IC HD towards the cost of conducting the pivotal study.
$5 million of such commitments have already been advantaged to the NIH.
As of November nine 2022, dairy had approximately $84 8 million shares of common stock outstanding.
So in closing, we will endeavor to be creative collaborative and opportunistic in seeking the capital necessary to advance our candidates and build shareholder value.
As Sabrina noted we encourage all investors to review the more detailed discussion of our financials financial condition liquidity capital resources and risk factors in our Form 10-Q for the quarter ended September 32022, which was filed today as well as our annual report on Form 10-K for the year ended.
December 31, 2021, which was filed on March 31 2022.
I would now like to turn the call back over to the operator.
Thank you the floor is now open for your questions. If you would like to ask a question. Please press star one on your telephone keypad.
If at any point, you would like to run Nathan yourself from the queue simply press Star one again.
Your first question comes from the line of Kumar Roger of Roth Capital.
Congratulations on the progress and thanks for taking my questions.
So first with regard to all upstream.
What how do you would expect based on inbound calls and.
Meaningful Paul indexing.
Required.
Thank you for that thank you for the question and for dialing in.
And it's a great question about evergreen.
As we think about in and allow me a second to just take a step back and just make sure everyone's grounded around the contraceptive categories and the different drill indices.
Joe the Pearl and next is the way that you know, particularly the drug division of the FDA has established to look at and be able to have a metric that you can compare right different contraceptive products to each other in terms of their effectiveness.
Little bit of a funny number because it's.
It's tied to kind of pregnancy risked out of out of 100.
Women and and so it's a little bit of an interesting metric that they use but it's it's symmetric and so when we think about contraceptive methods out there today in both the hormone is a hormone free category.
Pearl indices are very broad in terms of range. So you'll have products that are implanted.
Where the Pearl index can be as low as as one and the way to think about it is.
Essentially the inverse of the Pearl Index is the likelihood of becoming pregnant. So a product with the Pearl index of one like an implant where it gets where there's no really human error.
That can be involved you know that's essentially a 99% effective product and then the Pearl indices range and and your typical use therefore effectiveness numbers range.
Hormonal products.
Are also pretty broad range in terms of pills patches and there's new data also.
Looking at women with higher BMI and reduced effectiveness and higher BMI. So as you start to look at homeowner products. You can help her own index indices as low as you know one or two and as high as eight or nine.
And then you have products.
In the non hormonal category.
Where do you start thinking about things such as.
Condoms and so a lot of the devices aren't regulated exactly the same way. So you only see that the effective December so a condom typical use effectiveness would be expected to be about 82%.
If youre looking at spermicide, that's about 72% or that would be a parole indexes that 27 or 28, and then you've got vaginal gel prescription products Pearl index of 27. So as you can see there's a very very broad range.
Throw in disease for FDA approved products and as John in particular mentioned overtraining does not fall into.
Any particular category right of product it's the first.
Or are you know non hormonal monthly non hormonal product. So it's not an implant, but it's not in the moment.
It's a once a month product and so as we think about rail indices.
One can think about the relevant curling disease too to think about comparing two for product of this nature. So if youre looking at.
Monthly contraceptive products, obviously with hormones like and you have a rig that's gonna have a thrill index that's more in that.
Two to 578.
Right range, if you're thinking about it.
Any sort of of the hormone.
Short acting message, so again think of that sort of range and theres perfect used untypical use so.
A little bit complicated in the data, but that's your range to think about and then like I said, you've got condoms, which right now are the most commonly used hormone free short acting contraceptive option.
So that's a typical use effectiveness of 82% so the inverse of that would be a pearl index.
18, or so and then you've got again the in the moment.
Either in the moment vaginal products.
Like is from our side or like a vaginal gel and those Pearl index or true indices of 27. So as you can appreciate I mean, you know you want a product like <unk> and given the form factor, we obviously want it to be as effective as possible based on the post Coital test study, which is the pre pivotal study that was completed.
Which looked at.
A proxy.
Typical use effectiveness I'm using a surrogate marker where you look at you know the ability of sperm to get into the cervix, which you said, which has been shown through other studies to be a nice proxy for a contraceptive effectiveness at least translated into that typical use effectiveness numbers.
You know that would anticipate typical use effectiveness of 86% to 91%, which would translate into you know that Pearl index range. It would be if you think of the inverse of that of nine to 14, So youre starting to see it you know what.
What one would anticipate from a product like <unk> is to be in that similar range to similar types of.
Products and similar form factors that you know like <unk> have a double action, it's got a physical barrier and chemical.
Chemical barrier, so, but the range is pretty broad right of where it could play.
And so that's really how that's right now the best way, we can look at it is to think about it in this context and one of the things that.
Obviously as we're going into the pivotal study you know obviously, how the data are going to be ultimately calculated.
And and how the Pearl index is calculated, particularly when youre dealing with a non hormonal product in cycle lengths can be very variable.
This is certainly one of the things that we want to make sure. We're very clearly aligned with on the F. D. A.
That study because it can it can really impact your numbers in terms of how it's calculated when you don't have standard cycle lengths. So.
So it's a very important consideration and I appreciate the question and hopefully you get a sense to that.
Contraceptive methods. It it's not all about the efficacy right. That's why they're a contraceptive methods approved and available to women and have a very very broad range of efficacy.
It's about one factor as well and what we're hoping for with evergreen and based on the Postcoital Test study is that it delivers on all fronts right that it has that convenient form factor and based on the Postcoital test study.
It should put us in a nice range of effectiveness based on those data that would be in more of that condom too.
Short acting hormonal method range. So hopefully that helps answer the question hopefully that gives everyone a little more perspective on how contraceptive methods.
Are evaluated and how we think about them both from a personal perspective and also a regulatory perspective.
Yes, that's really helpful.
Brian with regard to this 200 subjects.
You plan to enroll in the study.
What is the expectation in terms of the timeline for that.
Also what you would expect based on in terms of the drop out great for that.
Yeah.
Patients who will be included there. Thank you.
Yeah, Great question. So do we know from other contraceptive studies.
That they dropped out ranges can can range based on all the published literature and also from just the learnings we have of working with the NIH in their contraceptive clinical trials network is it. The range is is a pretty broad in terms of dropped dropout rates amongst studies, but it's in that sort of 35% to 55% range.
Particularly because these studies are likely evergreen study.
12 months of duration.
That you expect to follow a woman in the study and that's definitely the expectation here for <unk> for the pivotal. It's a 12 month study as following the women and so we are planning for because we think that's the most prudent thing to do we're planning for the higher dropout range in that in that range right in that range. So.
That we can make sure that we adequately.
Enrolled the study to ensure that we have the target 200 women completing the.
For the full 12 months of other print use that we're targeting so you should expect that we would start with the number.
Double or more than double.
That in terms of who we're going to seek to screen and enroll in the study, which then segways nicely into your question of well how long does that take.
You know to get those women in the study and that's you know that's one of the places where working with the NIH in their clinical trial contraceptive network is very helpful. Because they have a lot of experience with these kind of studies, both with hormonal products and non hormonal products and and maybe not surprising as enrolment rates can be a little different hormonal non hormonal products.
Studies actually tend to enroll a little faster.
Then hormone releasing products. So that's exciting, but having said all of that right now the only guidance. We're ready to go at this point until we really get in recruitment underway and have a better sense of the metrics ourselves for our specific product in our specific study is that you know we're looking to start out those recruitment activities.
Mid next year.
And and once that gets underway and we have a good sense of what trajectory we have in terms of those enrollment potential enrollment numbers.
Our site then we'll be able to give some guidance on you know how many months it is going to take us to enroll the subjects that we'd need but in terms of when one should expect data from this study.
You you being realistic it's going to be at least 12 months out right. It's a 12 month study and so it's really just a matter of how much in advance of that 12 months.
Do you know time do we need in order to fully enroll the subjects.
Studies, so more to follow on that but hopefully that gives at least a little perspective of how have you been thinking about it and what's been seen with.
Other products.
Great. Thank you.
Absolutely.
Again as a reminder to ask a question. Please press Star One. Your next question comes from Douglas Tsao of H C. Wainwright.
Mr. Zhang Your line is open.
Again to ask a question please press star one.
This concludes the question and answer session of today's call I will now turn the floor back over to Sabrina.
Great well. Thank you so much and thank you all for taking the time. This afternoon to hear about the recent updates in our ongoing commitment to drive value for all of duration stakeholders, not just the shareholders and definitely to shareholders, but also the women and their health care providers as well and with our diverse portfolio, we seek to bring to market differentiated prescription.
Therapies that.
Our ties them into health and wellbeing expand the treatment options, where none exist enhance outcomes, where current standard of care has meaningful shortcomings and improve ease of use for women, where a more compelling form factor can drive adoption, primarily in the areas of contraception vaginal health sexual health and fertility today.
As you heard we have seven candidates in various stages of development and one FDA approved product and to commercialization collaborations under our belt.
As I mentioned at the onset of the call. It is our belief that prioritizing women's health is good for the many women lacking effective or convenient therapeutic choices and also good for a broad set of stakeholders, including their families and partners and of course, our shareholders and it's our belief that the programs in our portfolio.
Represent a compelling opportunity given that potential commercial partners are looking for new differentiated products and candidates with meaningful revenue potential to add to their portfolios.
Providers are looking for innovative first line or first in category product to address the unmet needs in passing the quality of life of so many of their patients.
Women are seeking innovative options to help them navigate their needs and preferences over the course of a lifetime and investors are looking for a diverse pipeline with high revenue potential and with independent outcomes to mitigate risk and enhance the overall commercial opportunity and.
Where the investment has the opportunity to be disproportionately impactful.
We look forward to keeping you updated on our progress through the balance of this year and into 2023 on the milestones forthcoming for our candidates under development and as well as activity with organized regarding Zachi auto launch in the U S that are underway. Thank you so much.
Ladies and gentlemen, thank you for your participation in today's event you may now disconnect.
Okay.
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