Q1 2022 Obseva SA Earnings Call
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Thank you operator, and Hello, everyone. Thank you for participating in the third quarter 2022 earnings conference call members of the absorber team joining me on the call today are Brian Callahan, Our Chief Executive Officer, Brian Howard, Our Chief Clinical Officer will Brown, our Chief Financial Officer and class action are cheap.
Commercial officer following their prepared remarks, we will hold a question and answer session. A press release without that quota Twenty-twenty Chief financial results was issued this morning and can be found on the Investor Relations section of the company's website.
Before we begin I would like to remind everyone that any remarks made on today's call that express a belief about future expectations plans prospects or the company's future performance.
She always looking statements under the private Securities Litigation Reform Act.
Forward looking statements are based on information available to the company's management as of today and are subject to risks and uncertainties that could cause actual results to differ materially from those indicated.
For a discussion of some of the risks and factors that could affect the company's future results. Please see the risk factors and other cautionary statements contained in the company's filings with the SEC, including that ignited in the company's annual report on form 20-F for the year ended December 31, 2021, and no earnings press release.
Issue today and now available on our website.
Statements made on this conference call speak only as of today's date Tuesday May 17, 2022, and the company does not undertake any obligation to update any of these forward looking statements to reflect events or circumstances that occur after today's date, except as required by law.
As a reminder, this conference call is being recorded and will be available for audio replay on our website with that I will now turn the cold I bet, you, Brian Callahan, Chief Executive Officer of CEVA.
Thank you Katcha and Hello, everyone. We appreciate you joining us today for a discussion of our first quarter 2022 financial results and business update.
'twenty two is an exciting year for CEVA as we eagerly anticipate approvals for Olympic Alex in both the U S and EU and then our transition to a commercial stage company.
The cost of these key milestones we wanted to share more details on what we see as the market opportunity for Lindsay colleagues for uterine fibroids are commercial launch preparations and how this program aligns with our mission to bring much needed innovation to the field of women's health.
Our goal is to address the most challenging unmet needs facing women and our lead program for the treatment of uterine fibroids is a prime example of the large underserved indications that compromise female reproductive health.
So one for U S. Almost 20 million women are affected by uterine fibroids.
And at least a quarter of those experienced symptoms such as heavy menstrual bleeding pain or prolonged periods, which can have a devastating impact on day to day life.
Current standard of care has largely been off label contraceptive and then said with many women historically forced to choose between surgery or waiting for menopause for longer term belief, which is unsatisfactory and creates a very large unmet need.
She interacts antagonist are relatively new class of drugs poised to revolutionize the treatment of uterine fibroids, and we think Lindsay Garlic's has the potential to lead the category.
The Olympic Alex program is currently before each of the European Commission and FDA for review and if approved will be the only approved oral gnrh antagonist to offer flexibility and choice for women suffering from uterine fibroids.
<unk>, a non hormonal dosing option to address the needs of women with uterine fibroids, who cannot or do not want to take hormone.
The last point Theres, a teasing, we believe up to half of U S. Women suffering from uterine fibroid may have a contra indications of hormonal add back therapy.
From our market research, we also know that many more women, who orange country indicators, but simply prefer not to use hormonal add back therapy, if given the choice.
Lindsay Garlic's has the potential to for the first time, an unapproved products offer choice and flexibility to women with uterine fibroids and the physicians who treat them.
For women, who can and want to take hormone. We've designed the dose that includes add back therapy and has the potential to offer a best in class a vacancy rates and tolerability profile, which if approved should position us strongly against other drugs in the class the target this patient segments.
Importantly for women with uterine fibroids, who panels address risk golf are simply do not want to take hormones, which as I noted may account for at least half the patient population Lindsay Garlic's has the potential to be the first and only approved oral gnrh antagonist that does not include hormonal add back therapy.
Accordingly, we think we have the potential to be the best in class are the first and only approved option and the main patient segments for this class of drugs positioning Lindsay garlic's strongly from a competitive perspective.
Last month the C. H M. P confirms its a positive opinion recommending approval of Lindsay Garlic's for uterine fibroids by the European Commission.
If approved this would be an historic moment trups, either representing our first approval and validation of the work we're doing to improve the reproductive health of women, which is far too long been overlooked and undervalued.
We are actively working with our partner southern mix on launch preparations in the EU in parallel preparations for the commercialization of Lindsay garlic in the United States are advancing through our relationship with Cvs health as we approach I could do for date of September 13th later this year.
Together these agreements are expected to maximize the market opportunity for Lindsay Garlic's and our chief commercial officer will speak in more detail on our commercial preparations momentarily.
Turning to our second indication for Lindsey Alex here, we are once again seeking to address a large unmet condition, but severely impacts the quality of life of women, who suffer from this disease.
And Jimmy trials. This is an emotionally and physically painful condition that affects close to one in 10 women during their reproductive years and there's a critical need for therapeutic options to address this chronic disorder and.
In January we announced positive topline results for our phase III Edelweiss trial in patients with moderate to severe endometriosis associated pain.
We hosted a call at the time to discuss the results in death, and Brandi Howard our Chief clinical officer will recap the highlights shortly.
We were extremely pleased with the phase III results, which highlight the promising clinical profile of the Lindsay Garlic's 200 milligram once daily dose with add back therapy for women with moderate to severe endometriosis associated pain and underscores the potential to be a leading gnrh antagonist.
Option that balance of safety and efficacy.
We also believe the results from the 75 milligram without additional hormone therapy are strong there for warrant further evaluation of a lower dose.
Consistent with our commitment to addressing the individual treatment needs and preferences of all women, we intend to discuss next steps with regulators in the U S and EU for this program.
Yeah.
Beyond Lindsay Garlic's, our attractive pipeline also includes Eagle difference to address the significant unmet need in preterm labor.
Future path of EBIT difference was established last July with our development and commercialization agreement with the Oregon up this.
This collaboration which includes tiered double digit royalties on commercial sales as well as up to 500 million in upfront and milestone payments is an important validation of our ability to generate value.
Oh, the preterm birth rates are on the rise with one in 10 babies born preterm in the U S. Each year. There are currently no approved therapies no other known compounds in development for acute treatment of preterm labor.
We are working closely with the Oregon on the FDA submission of an investigational new drug application for IBRA victims expected for this year to enable clinical developments in the United States.
Finally, we are continuing to advance the development in the last few months to improve life birth rates in women undergoing in vitro fertilization via our partner you Yawn Bioscience technology in China, which has the largest IVF population of the world are in agreement with you and also allows us to use these new clinical trials all should they supports further develop.
In the United States and Europe .
Yeah.
In parallel with the advancement of our promising pipeline, we continue to explore new indications partnerships and other strategic opportunities that further our mission of advancing the field of women's health.
There are many large unmet indications that compromise female health together with undervalued assets in the sector. Just as biotech has come under strain of recent times women's health companies. Many of them are attractive assets and promising pipeline have not been immune to market forces.
We believe the current market conditions present opportunities within the sector and that we are strongly positioned to be a catalyst for any rollout merger or acquisition partnership or licensing opportunities that may present, as we look to enhance our value and fully realize the potential that exists within the sector.
It is now my pleasure to introduce you to our new Chief Technical Officer, Dr. Randy Howard.
Branding is a recognized expert in women's health with demonstrated success, leading women's health chemical development programs Medical Affairs organization, new product launches and regulatory processes.
She was most recently head of medical and clinical affairs that evil fan Biosciences, where she led the clinical program for the FDA approval effectively.
As well as the creation of the medical Affairs organization in support of the launch at least market expire at this market experience makes him the ideal person to take up C that into our next phase of growth.
She will now provide an overview of our clinical and regulatory progress.
Randy.
Thanks, Bryan it's a pleasure to be speaking with you all today I'm excited to be joining up CEVA at this pivotal time for the company as we work towards the approval of length in Gaelic for uterine fibroids, and Europe , and the United States potentially in the next six months.
Well its regulatory review processes are currently on track and the EU. We received confirmation of C. H N P. As positive opinion in late April and month ago Lakes is now being recognized by the European Commission.
In the United States, we haven't set as a target action date of September .
2022 and where we would expect to be in the regulatory review process at this time.
As Brian noted, we believe what sets the Wednesday Garlic's program apart is the potential to provide individualized treatment option to them.
Yes, the needs of all patients, including for the first time, an unapproved product that was one.
Women, who are contra indicated to Atlas God I prefer to avoid hormonal add back therapy.
We're at this category of patient we have a 100 milligram dose Atlantic all ex without add back therapy, which delivered statistically significant and clinically meaningful result.
For those women, who can and want to take hormonal add back therapy, we have a 200 milligram once daily dose in combination with hormonal add back therapy.
What we believe to be best in class efficacy and a differentiated PK PD profile, including high bioavailability for reliable absorption of half life that allows for a convenient once daily dosing no food effect and strong safety data, including minimal bone mineral density changes.
We are confident that if approved that's dosing options could compete favorably in this class.
At <unk> earlier. This month, we were pleased to present four posters and oral presentations from the phase III Primrose studies of length of Gaelic for uterine fibroids.
Additional analyses and post treatment data from the study continues to underscore events like all access clinical or your quality and differentiated profile and demonstrate its potential to balance safety efficacy and adjust the wide range of symptoms of uterine fibroids.
We have a number of other congresses upcoming I think educate practitioners ahead of launch with length of garlic data could be featured in a poster presentation at the international Society for <unk>.
The classical endocrinology World Congress and two oral presentations at the society of Endometriosis and uterine disorders Congress in the coming months.
Turning for a moment to our second indication for Olympic all ex endometriosis.
Very pleased with the results we reported for the Phase three study early in the first quarter.
For those who may not be familiar with endometriosis. It is a common chronic and progressive disease affecting approximately 180 million women worldwide.
The most typical symptoms painting administration also known as dysmenorrhea.
This may also experience non menstrual pelvic pain, a number of other pain symptom and in fertility.
And then she has this pain can be so severe and debilitating that's frequently negatively impacting overall physical mental and social wellbeing.
Consistent with uterine fibroids, our approach is to provide flexibility and choice for women. When it comes to treatment of this condition by way of doses, both with and without the use of hormonal add back therapy.
The highlight the key results of the trial once ago 200 milligram with add back therapy met both co primary objectives of reduction in dysmenorrhea and non menstrual pelvic pain at three months.
We also saw statistically significant and clinically meaningful improvement at six months and five ranked secondary endpoints.
This minor yeah, non menstrual pelvic pain, that's correct, yeah, overall pelvic pain and the ability to do daily activities.
The 75 milligram dose without add back therapy, Likewise demonstrated a statistically significant reduction in dysmenorrhea and showed improvement.
It did not move with her primary objective of non menstrual pelvic pain.
Improvements were also observed at six months and the first five ranked secondary endpoints.
The 75 milligram dose did not meet the non menstrual pelvic pain endpoint that's cyclical.
Quickly significant and clinically meaningful of responder rate versus placebo I guess malaria at three months and the evidence of clinical activity and Tolerability at six months are encouraging.
Taken together, we believe these results support further development of Olympic All acts in the endometriosis indication and we plan to discuss next steps with regulators, including exploration of a non add back therapy dose option as we believe endometriosis remains a crucial unmet need.
A large global patient population and women deserve options and flexibility in their medical treatment.
We announced the additional efficacy results from the phase III Edelweiss three trial in March which further builds on the positive top line results announced in January .
Adding demonstration of rapid onset of treatment effect impact on quality of life and the intention for surgery.
We also expect further phase three data for the post treatment follow up mid year and the data for the post treatment follow up for women, who enter the extension, which is the majority of patients by early 2023.
With that I'll now hand, the call over to Clive Bartram, our chief commercial officer to discuss launch preparation for Olympic Aleks.
Yeah.
Thank you brandy.
We believe <unk> has the potential to change the treatment landscape and become the standard of care for women with uterine fibroids.
Brian Nice to the unmet need is great.
These 5 million women in the U S with uterine fibroids experience symptoms of which at least to me in heavy menstrual bleeding seek treatment each year.
The majority of these women styles first line therapy, which is more often than not and overcome cassette to Florida inside and then tend to cycle through various therapies, hoping for sustained release.
Gnrh antagonist like after a new golf's under treatment for uterine fibroids, and we believe Lindsay go like suck a potential two don't tell me lead the class in terms of efficacy profile.
But also for the first and only approved oral gnrh antagonist option to address the needs of women who calls are at risk.
Simply prefer not to take additional momentum.
Terrific.
This is a key differentiator for Lindsay go lakes since as many as half the literally with your theme park rides may how about country indication to whole nonetheless therapy due to conditions, such as uncontrolled hypertension, dyslipidemia vascular disease under obesity.
Beyond this our market research suggests an additional 20% of women with uterine fibroids, if given the choice with centrica to not to use hormonal therapies, which are the only options. Among this class of drugs on the market currently.
So if a crude moons ago lakes will be the only approved dosing option without hormonal add back therapy to address what could become the largest patient population in this class offering patients and physicians for the first time in an approved product personalized treatment options to address all patient segments.
In fact, our market research suggests that even in the patients who are able and willing to take additional calls later line therapy. Many physicians would still consider initiating a lower levered milligram noncore another dose of that first line therapy.
For the patients who can tolerate and are happy to take additional pull down electronic therapy, we believe Linda galaxies profile with its efficacy PK PD profile that gives truly once a day dosing no food effect, great bioavailability has the ability to compete and differentiate.
And that's a hard choice with existing drugs in this patient population.
I will go with them to go with just to provide for the first time in a crude product women in positions with dosing options the addressable patient needs.
Approach is consistent with what AZ G. A I N. So telling us all that most pressing requirements, namely a therapeutic that affectively juices heavy menstrual bleeding and pain.
Safe and convenient to use and importantly can be used by the whole spectrum of women with uterine fibroids, including those countries indicated against that risk.
Or who don't want to take additional four megawatts therapies.
Turning to our launch preparations with the announcement of the Terramax licensing agreement European commercial preparations are advancing and we have a strong foundation to realize the commercial potential of dividends at Calix program in yogurt.
<unk> is a proven global leader in women's health and other direct track record of successful product launches.
Can it be ideal partner to maximize the opportunity for them to go with some key international markets.
They are one of the few pure women's health companies and this program has the change you can pull it tends to that and considering the emerging importance of gnrh antagonist endometrial polyp grade treatment paradigm.
<unk> extensive women's health commercial infrastructure and creates a Teddy case itself goes up more than 180 experienced representatives across Europe , Brazil and Australia.
<unk> coffee distributions across approximately 60 countries in Europe , Middle East Africa Asia Pacific Latin America.
With Terramax moving ahead on the European launch. It also allows us to focus our full attention on our U S launch strategy.
In the U S preparations for commercialization of them and the girl on the balance sheet through our relationship with Cvs health as we approach our produce a target action date of September 32 this year.
They have been indulging over 50 launches over the last five years, including 10 in women's health across an array of indications.
City office clients, probably big pharma to single product companies.
The beauty of the cineaste offering is that we will have access to the capabilities and experience of dedicated sales marketing medical affairs and market access seasoned professionals with the flexibility to dial a pull down our footprint as needed.
Our sales force will be fully dedicated to Lindsay Goldberg and comprised of experienced women's health sales representatives with established relationships in the sector.
Our loan strategy comprehensively addresses the needs of providers payers and patients.
Both described as Google position, regardless of crude that's providing the best efficacy across patient profiles and the only option to address the different needs to old patient categories, including those women, who called our at risk off what I want to take a cold metal contract therapy.
We understand from a physician research having optionality is something that physicians really do appreciate our focus here will be on education, and we've already been paving the way he spoke ascribing knowledge on them to go to our medical affair strategy.
Specially at key Congresses, where we have been educating them on the need for a non hormonal add back therapy options.
Our focus will be on the highest describing H C. P's and believe we can have a competitive share of voice here.
We believe lends ago looks as potentially best in class profile and ability to provide choice and flexibility to the hugely popular patient population currently not addressed by the available G&A chart antagonist are important differentiators to payers and if approved we expect to go on a broad support and coverage person launch.
In summary, we believe the Lindsay Goldberg product profile, combining potentially best in class efficacy with the army dosing option to address the needs of patients who cannot or at risk.
Simply don't want to take hormonal add back therapy, alongside our commercial relationships.
Position this program to become a leading.
Beauty in the class.
We look forward to updating you further on our launch preparation in the lead up to anticipated approvals.
I will now hand, the call over to will cause a discussion on our financial results.
Thank you Clive and good day, everyone for today's call I'll be providing a brief update on <unk> first quarter 2022 financial and operating results.
More comprehensive information can be found in our form 6K filed with the SEC today.
Of CEVA ended Q1, 2022, with approximately $58 million of cash on hand, compared to $55 million at the end of 2021.
The increase in our net cash is attributable to over $20 million of grocery seats. During the current period, including $5 7 million of gross ATM receipts.
$8 3 million in proceeds from our convertible debt agreement with J J B.
A $5 7 million upfront payment related to our <unk> licensing agreement with their mix.
All set by cash used for operating and investing activities.
Turning to the income statement revenue in Q1, 2022 was $2 2 million compared to 6000 in Q1 2021.
The change in revenue between periods was due to the partial recognition of the upfront payment associated with the aforementioned they're mixed licensing agreement.
We expect to recognize the remaining amount or $2 5 billion euros. Once Lindsay Goldberg says awarded marketing authorization by the European Commission.
Research and development expenses were $5 6 million in Q1, 2022 compared to $15 5 million in the prior period.
The decrease in R&D expense was primarily the result of the timing of clinical trial activities for Lindsay Goldberg.
In the prior year period, the company was recognizing material clinical trial costs for both the endometriosis and uterine fibroids phase III trials. During 2022 R&D costs, primarily reflect endometrial was just related costs associated with the Eagle Vice trials.
The Primrose trial cost associated with uterine fibroids are substantially complete.
General and administrative expenses were $7 2 million in the first quarter of 2022 compared to $4 2 million in Q1 2021.
The increase period over period is primarily attributable to commercial launch related costs.
Net loss for the three months ended March 31, 2022 was $11 8 million or 14 net loss per share compared to $20 million or 29 since net loss per share for Q1 2021.
The difference in net loss is primarily attributable to higher revenue and lower research and development expenses offset by higher general and administrative costs.
In closing the year ahead is expected to be transformational for <unk> as we pursue our first a pretty wholesale whimsical looks and expect a transition to a commercial company.
We believe <unk> has the potential to change the treatment paradigm for women with uterine fibroids and we look forward to advancing our attractive pipeline as we further our mission of bringing novel therapies to market and improve women's health.
We will now open the call to questions.
Operator will you please instruct the audience on Q&A procedure.
Thank you we will now begin the question and answer session.
That's a question you May press Star then one on your telephone phone.
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To withdraw your question. Please press Star then two.
Today's first question comes from.
Nah Canaccord. Please go ahead.
Hi, Thanks, guys for taking my call busy year. This year for you guys.
Wanted to ask just with regards to Lindsay Goldberg for endometriosis.
I know that youre going to be getting additional data coming out and then as far out as two early 2023 for the post treatment follow up extension are you going to wait until you have that that in hand before you have any discussions with the FDA on the next phase III trial or is that something you plan on doing.
This year.
Hey, Thank you very much for the question Great question I'm going to hand, you over to Randy Howard our Chief clinical officer.
To answer that one.
Thank you for the question, yes, we will be and communication with FDA before the end of year.
Okay great.
And then can you just remind us I don't know what the F. D. A came out I can't remember if they openly came out and told you there'll be no AD com or is it just in you are preparing for it but assuming there won't be one.
We've heard nothing from the F D. A to imply that we should expect an AD com at this point.
Okay and then my last question is can you just I'm just remind us just with regards to the uterine fibroid indication.
And I guess, maybe this is more of a Clive question is can we should we be looking at they already are.
Proved a gnrh antagonist out there to get an idea of what an initial launch should look like or because of the fact that you offer the option of not having add back therapy would we expect maybe a a bit of a more steep trajectory and uptake.
Yeah. Thanks, Jeff Yeah, I think it's a great question I think for the classic is still relatively early stages for the development.
But I think what we are saying is that each new entrants come again, he is starting to grow with the market as a whole, but I think youre correct in terms of that the whole market and sensitize current patients who are seeking treatment at the moment you know from our what we would suggest that the parent would your initial antagonist ceremony addressing it maybe half of the market.
They can address those patients who are counter indicated at risk of old Macarthur avoid hormonal therapy.
Got it thanks guys.
Ladies and gentlemen, our next question comes from Nathan One thing just trouble.
Yeah.
Hey, good morning, Brian and the team. So thanks for taking my questions and we really appreciate all the insight on the call today on this first questions for Brian Brian .
Brian could you talk about the hires you've made to build out our management team kind of what goes what are you looking for during that process and then how is the current management team situated I should transition to a commercial stage company.
Sorry, Nathan the last sentence of your good piece you you broke up just on that last night.
Okay and the last part of your question was how you think of your management team is kind of suited to transition to a commercial stage.
Right got US Yeah look I think the philosophy that we missed as almost the answer to the question Nathan but good. Good question as it is I think I missed the start of the process.
Really 18 months ago, when the board's realize that this company was about to make the transition from being a late stage clinical development company and that was going into submissions and subsequently.
For success, becoming a commercialized company. So the transition has actually started at board level, and and and then materialize executive team level as well.
So if you look at the board for example over the last 18 months since I arrived we brought in and then learn from the financial perspective, where she brings.
Seasons.
You know our board member who has.
Has incredible experience at board level dealing with investors analysts the streets and helping us make that transition from a company who was you know obviously planning for financing themselves for clinical trials that you know planning for financing themselves for commercialization.
Talking about you know going through that process. Obviously it started with submissions we also need this.
That that level of seasoned experienced from a regulatory perspective as well. So we brought in catarina itself at a board level, who was the global head of regulatory for a large pharma company and brought that level of experience from both sides of the Atlantic So dealing with the EMA as well as the FDA and then finally, Stephanie Brown from a commercialization perspective.
So that's when planning and decision making at board level, we had the the areas of core competency that were required for this stage and stage that the company is that now at board level as opposed to the boards that exist at the time that reflected a different time, which was the majority of your stage company. So all very amicably transitions to <unk>.
That's now prepared for commercialization, so that the trickle down of course into the executive team where.
Where they were on top of transitioning from being a late stage clinical stage company to a commercialized company. We also wanted to transition much of the executive team to the U S where NASDAQ listed commercialization potential is far greater than the U S than anywhere else that we raise more money in the U S than anywhere else et cetera. So wanted it to be much more front facing.
With the investors investment banks analysts potential partners et cetera in the U S and therefore, most of the executive team now resides in the U S.
So we brought in a number of people some of them are announced on this call today to help US first of all migrate as I said, the executive team or elements of it to the U S as well as prepare for commercialization and in no particular order I'm talking about people like Luigi Moro, who brings core competency from a commercial readiness perspective.
18 months ago again, we realize that again, if we're planning for success, we needed to not just receive approvals would be in a state of commercial readiness, where we can actually supply products when and as needed in the market to Luigi has been a tremendous addition to the team know he's still he's based here in Switzerland, where operations at headquarters still reside around the house.
Who you heard today already brings clinical and commercialization experience that hasn't existed in the company till now so a core competency that obviously, we need to acquire and acquire more off so brand. He brings that commercialization perspective from a clinical and medical affairs regulatory perspective Blackberry.
We've just heard from as well Chief commercial officer again, bringing that experience that launch experience in women's health care experience that said that was required and that we need to acquire more off.
Capture viewer one of the things that we're obviously trying to do.
Sure than we've ever done before and today hopefully is a reflection of US is present in project ourselves to the street and all stakeholders more successfully than we ever have and we again are needed to up our game in that regard and bringing more core competency attach as our chief strategy Officer has definitely helped us in that regard.
Then finally will brown.
We obviously need to the CFO of U S. Based CFO that was very NASDAQ experienced in everything he has done at his previous company else immune suggested he'd be the perfect candidates for who we are now in and who we want to be down the road. So so we'll you know it was brought in obviously to.
Help out on the financial front so.
You know almost a complete overhaul.
Many levels of leadership of core competency at board level and executive team level also reflects the fact that we are planning for success that we are about to be commercialized company and that we needed to be more physically present in front facing in the U S.
Well fantastic. Thank you, Brian that's really helpful and just some exciting team that you've assembled I'm sure. You know we're looking forward to seeing what you can accomplish with this new team put together maybe just one follow up question for me and that's about the Gnrh antagonist class and Lindsay <unk> in particular, obviously a number of them.
Advantage as compared to the older line medicines for the treatment of uterine Fibroid also our research has turned up that patients are very interested in having more options for their U F. Treatment. So could you talk about you know what's the relative under awareness of this attractive profile up the class amongst H C P as in patients.
How much more room is there for education on the class overall.
Yeah, that's a great question, Nathan and I'm going to turn you over to cloud you've initially our chief commercial officer to talk about that for Brian do you maybe want to get in on this as well.
Yeah. Thanks, Nathan Diana Great question, and I think I totally agree with you the differentiation is going to be key for us.
In terms of overall education and awareness I mean, we've been out that you know without met if a fast strategy. So at peak Congress over the last sort of 12 to 18 months and some parents, who have really trying to hammer home. The message in terms of the unmet need for patients who are getting communicated at risk or if given the choice II.
<unk> decision, making would prefer to avoid taken additional home animal hormonal therapy.
I think we were at the start of that journey. So I think there's good awareness among the kols and we're starting to gain momentum and again put strategies in place some programs in place to Cascade that message down to.
I guess to the Kols and the Obgyn's prescribing of opioids in the offices, but I think we know that that's a really critical success factor for us and again, we're putting with Cerro <unk> in Europe , and with seniors health, helping us without launch in the U S. We're putting those programs in place.
To make sure that we achieve that and carry on that journey.
Two and three launch.
And I'll just add to that I couldn't agree more as far as the desire for women to have more choices I think Westland took all X, that's really well pay them a great opportunity for women to have choices with them without add back therapy, but you're right. This is definitely a hot.
Topic right now as far as educating H C piece on this concept as clients out of shared decision, making and making sure that they understand that this should be a conversation to be had but with the patient.
Okay Fantastic. Thank you Clive and thank you brandy and much appreciate it on the color and thanks again for taking my questions.
Yeah.
This concludes our question and answer session.
The conference back over to Mr. Callahan for any closing remarks.
Thank you. This is a pivotal year for <unk> as we eagerly await our first approvals.
We are confident that we have the right product profile and strategies in place to drive adoption of Lindsay Garlic's, if approved and redefine chair for the millions of women, who suffer from uterine fibroids.
I look forward to driving this momentum forward, while also staying apprised of opportunities to capitalize on the potential that exists within the sector and enhance our value.
I want to recognize the hard work and dedication of the subsea the team and the support of our shareholders as we deliver on our mission to advance the field of women's health, but that being said, we look forward to updating you on our progress again next quarter.
Yeah.
Thank you Sir.
Oh, well. Thank you all for attending today's presentation.
I liked your lines and have a wonderful day.