Q2 2021 Myovant Sciences Ltd Earnings and Corporate Update Call
Thank you for your attention.
[music].
Good day, everyone and welcome to my Life Sciences second fiscal quarter 2020 earnings Conference call today's call is being recorded at.
At this time I would like to turn the call over to Mr., Ryan Crowe Vice President of Investor.
<unk> relations at my again, please go ahead.
Thank you operator, good morning, and thanks for joining us today for a general business update and to review my advance second fiscal quarter 2020 financial results.
Joining me for today's call are done.
Dr. Lin Sealy, My Elvanse, Chief Executive Officer Frank.
Frank Carb.
President and Chief Financial Officer.
We'll go for it.
Interim Chief commercial officer, and Dr., one Camilo <unk> Chief Medical Officer.
In addition to the press release issued earlier this.
This morning, the slides that will be presented during todays webcast are available on our Investor Relations website investors about miliband dot com.
During the course of this conference call, we'll be making forward looking statements. These.
These include plans and expectations with respect to our product candidates strategies opportunities and financials.
All of which involve certain assumptions risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.
A discussion of these risks can be found in our latest FCC disclosure documents.
Addition, my event does not undertake an obligation.
Update any forward looking statements made during this call.
Oh.
With that I'll now turn the call over to Dr. Lin Sealy, My Evans, Chief Executive Officer Lynn.
Thank you Fred and good morning, everyone. Today, We will review my Theres progress today and more importantly, where we are headed as we approach our first commercial launch it.
At my there.
We aspire to redefine care for women and for men through purpose, driven science empowering medicines and transformative advocacy.
Our lead investigational drug candidate is really goldex, a small molecule oral generates receptor antagonist, which is being evaluated as a one to one.
Well they treatment option for women with uterine fibroids are endometriosis and for men with advanced prostate cancer.
We have developed two distinct formulations for rally colleagues, which will be branded separately. If approved first we have a really solid combination tablet for women's health and education.
We expect to have.
The single dose and one brand name for both uterine fibroids and trends and May trail.
For men with advanced prostate cancer, we have a once daily monotherapy tablet containing a higher dose could really go.
Since our founding in 2016, we have conducted five large multinational space.
These preclinical trials each of which has been robustly positive forming the basis for three new drug application for.
Well you go like combination therapy, we have conducted the liberty in Spirit program.
Liberty program in women with uterine fibroids consists of two positive phase three six months study.
Completed long term extension study and a one year randomized withdrawal study, which is ongoing this.
The spirit Endometriosis program consists of two positive phase three studies and a long term extension study, which is ongoing we.
We have also conducted a one year prospective observational bone density study in.
Untreated women with uterine fibroids in endometriosis.
For men with advanced prostate cancer, we are developing valuable as monotherapy. We have successfully completed our phase three HERA study design for global regulatory filings.
We have also a second therapeutic candidate under development for women with infertility.
With the MVP six though too is a novel oligo peptide kits tucked in one receptor agonist that has completed phase two a clinical study.
2020 has been a pivotal year for my have erred in uterine fibroids are end da was accepted for review and given an FC a target action date.
June for 2021.
We also submitted our marketing authorization application to the European Medicines Agency in March 2020.
Efficacy and safety data from our long term extension study evaluating women with heavy menstrual bleeding and uterine fibroids were presented during a prize winning oral presentation.
At the American Society for reproductive Medicine meeting in October.
In the study 88% of women on valuable as combination therapy achieve the responder criteria for reduction in menstrual blood loss at one year and on average women experienced a 90% reduction in menstrual blood loss from baseline.
Data from the Liberty program depicted an orange demonstrated preservation of bone density and women treated with really golec combination therapy over one year data.
Data from the natural history observational study consisting of 262 women with uterine fibroids is shown in green women and the natural history.
Hi, Betty were H. matched and enrolled concurrently at the same size as women enrolled in our Liberty studies, but did not receive generates treatment.
This is the first longitudinal dataset evaluating bone mineral density and pre menopausal women with uterine fibroids.
As you can see changes in density.
After one year and women with uterine fibroid treated with really a goalless combination therapy are consistent with those of untreated women.
We believe that rally equivalents combination tablet if approved has the potential to be a best in class medical therapy for the millions of symptomatic women with uterine fibroids.
We are.
Hello presented the efficacy and safety data from our two positive phase III spirit clinical studies in women with moderate to severe pain associated with endometriosis in October.
Oral presentation was selected as the best clinical paper in endometriosis at the SRM 2020 annual meeting.
Data.
Sales in a replicate phase three spirits studies evaluating women with moderate to severe endometriosis are presented in the orange columns that this slide approximately 75% of women responded to rally equal in combination with a clinically meaningful reduction in dysmenorrhea or pain during their period and also a significant rebound.
Reduction in this purulia are painful intercourse, a particularly important finding is this prunier is a very common and concerning symptom in women with endometriosis.
These benefits were achieved with minimal tolerability issues hot flashes and bone density loss costs.
Comparing data from different studies must always be.
Be done with caution, but especially in this case with different assessment measures for years.
However, as you can see from the data in this slide we believe valuable as combination therapy has an efficacy profile comparable to that of the high dose of Elagolix with a safety and tolerability profile more like that of the low dose of Elagolix.
We believe regular combination tablet a one pill once daily treatment for endometriosis. If approved is poised to have a differentiated profile from other approved in any chances treatments.
Our Anda for advanced prostate cancer was granted priority review and has an FDIC.
Good action date at December Twentyth 2020, the phase three data from the global HERA study in men with advanced prostate cancer were presented at the American Society of clinical oncology meeting and simultaneously published in the New England Journal of Medicine earlier this year.
On the business development front.
We have also been quite active in 2020 in March we entered into a license agreement with Gedeon Richter to commercialize rally Goldex combination tablet for uterine fibroids in endometriosis in certain international markets, including Europe, and Latin America in August we entered into a commercial collaboration agreement with Sanofi in pharmaceuticals.
A subsidiary of Sumitomo Dainippon pharma are majority shareholders to support the planned us commercialization of legal X, including logistics trade and retail distribution support as well as contracting and other market access services.
We also obtained an additional $200 million low interest five.
Your term loan commitment from Sumitomo Dainippon pharma with this latest commitment Sumitomo Dainippon total financing support for my event has reached $600 million, providing us with the financial flexibility to appropriately resource our potential upcoming launches, but without rights to really go lets itself.
In short we have been busy in 2020, and the fact that we were able to achieve all of these milestones. Despite the challenges posed by the COVID-19 pandemic is truly a testament to the dedication of all of the Maya and employees and our partners around the world.
The progress we have made so far in 2020.
We have positioned the next 12 months to be a truly transformational period for my event as we prepare for the potential launches of two products. Okay. Ultimately expected in three indications.
So our uterine fibroids program, we look forward to the FDA target action date of our end da on June Onest 2021.
We also anticipate a decision next year from the European Commission for a marketing authorization application.
Finally, we expect to report topline results from our randomized withdrawal study in Q1 and 2021.
For endometriosis, we plan to announce one year results from our spare at long term extension study in the first quarter of 2000.
The results of this study in addition to the positive phase three spirit, one and two studies are expected to form the basis of regulatory filings in the us and the year next year.
Finally, we look forward to the FDA decision next month for rail eco likes and advanced prostate cancer and if approved launching in the U.S.
In early 2021, we.
We also expect to submit our M&A for advanced prostate cancer to the European Medicines agency and the first half of 2021.
As I think about the next 12 months strong commercial execution is clearly my Vance highest priority and I couldn't be more pleased with the progress.
Commercial team has made towards this goal commercial execution starts with our potential launch of the prostate cancer indication in early 2021, an opportunity Adele will now discuss Adele.
Thank you and our long term goal for valuable it is to establish it as the frontline medical.
Therapy for men with advanced prostate cancer, we believe revenue goal IX could become the foundational androgen deprivation therapy for use alone and in combination with other prostate cancer medicines.
The commercial team has been working hard developing a comprehensive launch strategy.
Our cat following approval will enable us to rapidly and efficiently deliver revenue goal Ics to urologists medical oncologists and their patients.
There are 3 million men with prostate cancer in the U.S. upped those approximately 300000 patients are projected to receive and.
Virgin deprivation therapy, or a DTC in 2021 with the majority remaining on therapy for several years.
Prostate cancer is the second most common cancer in men in the U.S.
Notably more men with prostate cancer will die of cardiovascular disease, rather than a prostate cancer.
For itself this.
This is particularly important when we consider todays treatment options for advanced prostate cancer.
Now a few words on the current ABT market landscape.
Testosterone suppression is the first slide medical therapy used to treat advanced prostate cancer and inject.
Notable depot agonists, such as loop rely our the current standard of care. However, agonists injections must be given in the clinic and have limitations based on their mechanism of action.
Agonists result in an initial surge in testosterone that can exacerbate clinical symptoms of prostate cancer.
In addition, it can take TSH weeks to decline.
Finally, testosterone can take months to recover after agonists injections are discontinued due to their long acting depot formulations if.
If approved rally Bullock's would be the first and only GR antagonist.
Or advanced prostate cancer.
In addition to the convenience of being a once daily tablet. The HERA study demonstrated that 97% of men had sustained testosterone suppression to the target range and that value Bullock suppress testosterone faster than loop rely and.
Did so without the testosterone surge and clinical player.
Additionally, a higher proportion of men in the ready Goldex group achieved Ats a response by day 15, compared with those in the Liberalized group.
Discontinuation of real legal extreme at all.
Okay reversed testosterone suppression faster than after loop relied discontinuation.
In the Hero study 90 days following treatment discontinuation over half of men in the really Bullock's group achieved normal testosterone levels compared to 3% of man in the loop relied group.
Finally and Assi.
Safety analysis from the Hero study men in the revenue goal Ics group had a lower incidence of major adverse cardiovascular events compared to men in the loop relied group.
Given the extensive market research conducted to date with hundreds of patients physicians and payers I'm confident that real legal Ics.
If approved will have a significant role in the treatment of prostate cancer.
From a patient standpoint, our market research indicates that men one a pill not an injection.
In a survey of more than 500 men with prostate cancer, 62% were dissatisfied with the injection of loop Allied.
Men rated once daily oral as the most attractive attribute of really goldex.
Approximately 30% of men with prostate cancer have diagnosed cardiovascular disease and cardiovascular risk factors are extremely common in men with prostate cancer in.
In fact nine out of 10.
And enrolled in the hero study had at least one risk factor for cardiovascular disease, whether it be age hyperlipidemia hypertension diabetes smoking or be city to name a few.
From a physician standpoint, we have heard very consistent feedback and our market research and from AD boards for example.
In a recent survey of 407, urologist and medical oncologist, 60% indicated they are very likely or extremely likely to prescriber legal Ics based on it's clinical profile.
We've also found that physicians understand most of their patients are already at increased risk for cardiovascular.
For their disease.
Finally payer research in AD boards suggests that payers readily understand the clinical benefits of valuable both in terms of efficacy and safety.
They are particularly impressed by an economic analysis presented at the AMCP Nexis 2020 meeting indicating.
I think that the number needed to treat it's really goldex to prevent one major adverse cardiovascular event was 31 versus patients receiving will provide injections.
Our first launch priority following approval will be to leverage our very experienced 100 person sales force to edge.
Kate Urologist and medical oncologists and other prescribers on the safety and efficacy profile of really goldex. According to the prove label.
We believe that based on this profile established by the Phase III Heroes study religion, Bullock's has the potential to become the new standard of care for men with advanced prostate cancer.
In initially are detailing efforts will focus on high volume prescribers approximately 10000 physicians in the us that right most of the ABT prescriptions with a majority belonging to either multispecialty practices or large urology group practices also known as lug posts.
Approximately 60% of multi specialty clinics and load posts have in office dispensing capability and that proportion continues to grow year over year.
It is essential that we establish broad patient access our second priority here.
Here, we are taking a very deliberate approach.
Okay, seeing on pricing and contracting distribution and fulfillment payer coverage and patient support.
Based on our pre approval information exchange meetings payer headboards and payer research we are confident in our ability to gain coverage or commercial and part D patients with key commercial ppm.
Coverage decision starting as early as the first quarter of 2021 and continuing to increase throughout the year.
Our third launch priority is to raise awareness among patients regarding their prostate cancer treatment options.
We have identified through research a patient segment that is very engaged in their disease.
Ladies and actively seeking education.
The clinical profile and oral administration, particularly in the time of Cobot 90 is very attractive to these patients.
In summary, we are approaching this launch from a position of strength and look forward to delivering the illegals to patients early in the new year.
With that I will now turn the call over to Frank to discuss our second quarter financial results Frank.
Thank you Adele and good morning, everyone.
I will focus my comments on the highlights of our financial performance in the quarter and refer you to our press release and form 10-Q issued earlier today for addition.
Year on agent.
Please remember that my of its fiscal year starts on April 1st So the financial results for the quarter ended September Thirtyth of this year represent our second fiscal quarter of 2020.
R&D expenses in the quarter were $40.5 million compared to $50.8 million for.
For the comparable prior year period.
The decrease in R&D expenses reflects the completion and continued wind down of Vyvanse phase three programs, partially offset primarily by increased expenses associated with the build out of measurements Medical affairs organization in preparation for upcoming potential commercial launches are really goldex.
On the DNA expenses in the quarter was 31.3 million compared to 16.6 million for the comparable prior year period.
The increase was primarily due to increased spending on commercial readiness activities personnel related costs and other general overhead expenses as we continue to prepare for the potential commercial launches.
Total operating expenses for the quarter was $71.8 million of which approximately 7 million was stock based compensation.
We also incurred a 7 million dollar gain on foreign currency during the quarter that was recorded in other income line.
I haven't generated a net loss of 67.1.
Million in the second quarter of 2020 compared to 70.6 million for the comparable prior year period.
On a per share basis, our net loss was 75 cents in second quarter, 2020, and 79 cents in second quarter 2019.
Looking ahead, we expect.
R&D expenses over the next several quarters to be at similar levels to our second quarter 2020, R&D expense as declining spend on clinical programs that are winding down is expected to be offset by incremental spend on certain lifecycle management activities and potential new investments in our pipeline.
In upcoming quarters, where regulatory filing expenses incurred there could be modest deviations from this trend.
DNA expenses are expected to increase as we continue to build out our commercial capabilities.
Particularly driven by the hiring of oncology and women's health sales forces.
Hiring of our profit, Kansas sales force is well underway and expected to be completed in December of this year.
The majority of the hiring a lot of women's health sales force is expected to occur in calendar second quarter of next year as close as possible to the FDIC uterine fibroids target action date of June 1st 2021.
Let me wrap up by commenting on our cash position.
We ended the quarter with $111 million of cash cash equivalents and marketable securities on our balance sheet.
Note that we currently fund our operations through a low cost loan facility that Sumitomo Dainippon pharma, our majority shareholder extended to us.
In totality the loan commitments, including the 200 million committed in August 2020 amount to 600 million of which a portion has already been used.
In order to minimize our interest expense we draw from this facility on a quarterly basis to fund our near term operations.
The remaining bar.
Borrowing capacity as of September thirtyth, including the new 200 million commitment amounts to approximately 350 million.
Therefore in total between our cash and committed financing from Sumitomo Dainippon pharma, we had approximately 460 million available to deploy as of September thirtyth.
Lastly, without first drug launch anticipated in early 2021.
And the second one potentially by the middle of next year, both of which are targeting significant commercial opportunities. We expect our future cash burn to be partially offset as revenue increases.
Now I'll turn it back to Lynn for some closing.
Remarks.
Thank you Frank and Adele in summary, this is an exciting time for my event as we approach potential us launches of really go legs in the prostate cancer indication in early 2021, and the really good combination tablet in the uterine fibroids indications in mid 2000.
Anyway I.
Our focus is squarely on successfully executing will watch it and bringing these important therapeutic option for patients we.
We have multiple upcoming clinical data and regulatory milestones in the next 12 months and are in a strong financial position with approximately $460 million a cash.
20 committed financing to appropriately resource potential upcoming product launches.
Finally, we have full us rights for the revenue Goldex franchise, providing us with maximum optionality for business development opportunities.
I am extremely proud of all the work done by the management team to get to this point and I.
I look forward to what is ahead for my again. Thank you for your attention I'll now turn it over to Ryan to begin the couponing session.
Thank you Lynn will note before we open it up for questions given our ongoing discussions with regulatory authorities, we will not be responding to any questions regarding our regulatory interactions with that said.
Operator can we now please poll for questions.
Thank you as a reminder to ask a question you all need to press Star then one on your touched on telephone to withdraw your question from the queue. Please press the pound key please.
Please standby, while we compile the culinary roster.
Our first question comes from Jason Butler with JMP Securities. Your line is now open.
Hi, Thanks for taking the questions and congrats on the progress just a couple on the prostate cancer launch first you mentioned the 10000.
Hi volume prescribers.
Can you give us any more details about what.
Force.
Of those docs, you'll be initially focused on.
On what the split might be between those those.
The multi.
Stress centers versus.
Other docs and then.
Can you just give us a breakdown of the the market in terms of reimbursement between commercial and.
D coverage. Thanks.
Thanks, Jason.
Well.
When it's you take those questions.
Sure.
If I heard you correctly. The first question was with regard to the 10000 high volume prescribers, we expect very very substantial piece of our business will.
Apart from those multi specialty clinics, whether they be.
Urology clinics medical oncology or the luggage as I mentioned in the call because that's that's who is doing the large majority of prescribing the ABTS today.
And.
What was your second question.
And just how the market breaks out between commercial and part D coverage.
Okay.
It's approximately I would say 50 50, right, 50% of our business, we expect it to be a commercial patient so be commercially insured the other half patients out there are let's assume they are met.
Medicare there they're on Medicare plans.
From that proportion of Medicare patients important to note that about half of those will have plans that enable them to have a more affordable co pay they may either be on low income subsidies. They may have employer waiver group plan. So we feel there is a nice chunk or 20.
25% of that other piece of Medicare that we'll have.
A a plan that will enable them to have affordable access.
Okay, great. Thanks for taking my questions.
Turning next.
Question. Please.
Thank you our next question.
Often comes from Ami Fadia with SBB Leerink. Your line is now open.
Hi, good morning, Thanks for the question.
I have a couple firstly just with regards to your.
Readily preview for prostate cancer can you talk about any progress.
With regards to a pre approval inspection, but.
With the FDA and.
If you've begun any sort of discussions around labeling at this point.
Secondly, can you try to narrow down kind of your pricing philosophy for us both in prostate cancer as.
Well isn't weapons hope you're in prostate cancer on one hand, we have.
Look drawn if you can give us some color on where that the net price of Lupron stand and then of course, it's extend he is.
You know in tens and thousands of dollars, so where would you think about pricing ratable mix there.
And then I have one more question, but let me pause here well.
Sure I think through the questions. Let me begin with your question about regulatory approval I think we stated very clearly during this conference call that we are on track for the FDA approval action date or the PDUFA date December 20th.
2020 so.
We're pleased with the progress that we've made but obviously, we're not going to comment further on ongoing regulatory interactions.
I think with respect to price I. Appreciate the question, we believe pricing of new medicine should be based on the value that they bring to patients and our case with really got legs.
Based upon the efficacy and safety profile that has been presented in our phase three study published in the New England Journal and I think you know based on the value that really go looks brings to patients and particularly the lower incidence of cardiovascular events compared with flu provide looper life, we expect to.
Workspace Regal legs at a premium to the wholesale acquisition cost of of Lupron.
Got it okay.
That that's helpful.
Can you.
At this point and quantify how much of a premium or is it.
Probably to give that level of color.
Yes, I think we'll be talking more about price around the time of approval. Thank you okay.
Okay, if I could just off the question to it though just with regards to the launch ramp.
Where do you see relics getting the initial adoption.
Whether you know in in terms of which practices might adopt it first and also.
Patients with what stage of disease might be the first to get treated.
Well go next and then also put in context for us.
The initial launch ramp as we think about the time it takes to get coverage.
From payers and then you don't get the product sort of described and then.
Patients getting on the product thanks.
I will now.
Yes. Thanks, Thanks for the question Army.
A lot a lot packed into that so first I would say that our.
I want to reiterate physicians are very excited about the product profile as I said, there's in our most recent survey over 60% were extremely likely are very likely to prescribe really bullish based on the clinical profile. So we have that parameter that we're excited there is also very high awareness.
Among physicians early at this stage pre launches is a little bit atypical and it could be because of our new England Journal publication. So those two things from the physician from the physician. We also know that patients in a time that patience man truly prefer a once daily oral versus an.
In injection. So we think there will be interest from the patient community as well and then as I mentioned, our 100 person sales force. We are hiring very experienced direct reps, who have not only knowledge of the urology market place in medical oncology, but who are very adept at selling in this virtual environments. So we see.
And and done a very rigorous job and getting sales representatives, who have the therapeutic area expertise as well as the technology Expo.
Expertise as well so when when we factor all those together we feel that we will have a we have we are on track for a very comfortable.
Ramp up with with the physician community as well as the patients coming together.
And I will leave it at night.
Thanks, Alan I might just add to that that we all know that coverage takes time and so we expect that the revenue ramp will reflect that time that it's going to take ticket.
Screwed coverage and yes, there is a covered pandemic going on which we have been preparing to launch with and so that's no surprise, but it is important to consider I will say that that's offset by the fact that we're going to be offering an oral option from and where the current standard of care require them to go into the clinic for an injection.
Again so.
Again, we are as prepared to to launch into this covered pandemic as we can be.
Thank you.
Operator next question.
Thank you. Our next question comes from Mohit Bansal with Citi Your line.
I would now open.
Hey, Good morning. This is James on promoted.
Had a question for bill.
Could you for profit for profit kids was right around the corner.
Given we're still independent of what you guys mentioned can you tell us what you're seeing on the ground from the private neurology offices.
I know.
From the private urology offices can you just be a little bit more clear on that what we're seeing.
Well guess what are they open the patients right now are they still operating at full capacity. They actually it doesn't even have to be dr. dror job, let's just make it broader urology offices or are these centers.
Widely open are these sort of that.
95% capacity, what's what are you seeing.
Yes.
There, there's growing I would say, it's growing from where it was a couple of months ago now the oncologist that have been pretty stable and now the urology community is also picking.
Backup so there's the access to the two sales representatives is not the same in terms of in person, but there is access from a from a virtual perspective and what we're seeing is that doctors are very interested in the product profile of really galling and whenever you have a product like this.
I think that we feel like as we said could could actually represent a new standard of care. They want to hear about it. So we are having we've had no trouble securing.
Physicians to attend AD boards to go to meetings to answer questions that we have as we're doing our diligence so.
So we're we're pretty confident that the.
Yeah that the urology practices and the oncology practices will be open to hearing from our representatives, because we represent a really important product for them.
Got it and then if I may one more on I know you guys aren't going to give too much.
Status update on the filing itself, but could you could you share it.
If the bone mineral density for uterine fibroids was submitted to the FDA at least.
When Camilla.
Yes. Thanks.
Thank you I can confirm that and our initial idea. We included the data for the one year data for.
Uterine fibroids, a recording of that as well.
The data from more natural history study, one year or integrations with uterine fibroids.
Got it appreciate it thats it from my end.
Thank you next question Jamie.
Thank you and especially in resin Air Jain with JP Morgan. Your line is now open.
Hi.
Good morning, Thanks for taking my questions I guess first of all just speaking about products initially.
Mr product uptake in prostate cancer is there a meaningful switch opportunity here and then currently on SDG, either with one or another depot therapy.
And then secondly.
Thanks for highlighting.
Split between recovers during part D and commercial.
Is there.
Should we anticipate a different.
Differing rate in adoption for coverage adoption thats a different segments. Thanks.
Adele.
Yes, so I'll start with a rate of coverage.
Adoption, yes, because that because of the Medicare.
Bid cycle, we would expect to have information regarding our formulary coverage for Medicare by about June of next year. Realizing that there are also medical exception processes for patients that are on Medicare So that will come.
That's on the Medicare front on the commercial front as I said during the prepared remarks, we would expect to start seeing coverage as early as the first quarter of next year.
And then I think in terms of your second question about the opportunity for patients with really go looks again, we believe.
Leave really go looks as appropriate for a broad spectrum of men with advanced prostate cancer and that will include both treatment might naive patients as well as patients who are currently on therapy.
Okay, great. Thanks for taking the questions just one follow up if I could actually.
It's.
Maybe I could get you to speculate on sort of the importance of detailing to consumers and directing treatment decisions I guess to what extent longer term is did you see part of the.
One strategy earlier works in prostate cancer. Thanks.
Sure though.
Yes, Thanks again for for the question, what I would say its most importantly, we have to ensure that our positions are very well educated on the product profile and they understand it. So the last thing we want to do is drive patients into an office, where the physician is not adequately prepare.
With that said, we do appreciate from our market research that there is a very clear an identifiable pretty large segment of men who are very actively engaged in their disease and are constantly seeking awareness and education and wanting to know more about their treatment options. So at the appropriate time will ensure that.
We do that the adequate programs to reach these patients and their caregivers because we know a lot of.
A lot of these men have daughters, who are their caregivers and who also are very actively seeking information. However, when you say DTC that conjures up a lot of things Theres big broadcast.
TV the TV, that's not what we think is needed for this patient population, they're very efficient ways in which we can reach this segment and those are the plans that we have in place right now.
Okay got it thats helpful. Thanks for taking the questions.
Thanks, Eric next question please.
Thank you. Our next question comes from Brian Skorney with Baird. Your line is now open.
Hey, good morning, Thank you for taking the questions just a couple on on the impending prostate cancer launch I guess when I look at look for on it it's kind of difficult to track through new starts and I was wondering if you guys had any better data.
In terms of annual.
New starts to.
Castration therapy in the prostate cancer segment, and if you have any sort of indication in terms of how much that's dipped through the pandemic and and how should we be expecting sort of a rebound or even.
Warehouse.
Affect maybe once we get through the next couple of months and then just in terms of durability, what your sort of expectations are in terms of how long patients would be on.
Drug on average thank you.
Sure Adele.
Yes.
So let me just.
The first question around data, what I would say is.
From the research and as well as the Big secondary data pulls that we have indicate about 100000 patients new starts coming on 80 Ti as I said in prepared remarks, there was approximately.
300000 that were estimating will be on therapy, and 2021 with approximately 100000, new starts coming on year over year. That's what we have and that's what we've been forecasting our on our patience around those numbers with regard to I am sorry, I forgot.
But making sure had the out your information on on the data question what was your second question.
So it was just in terms of any any kind of data in terms of any dips and delays on starts due to the pandemic would you expect substantial decline given the increase in patients and.
I would would we maybe even expect some sort of warehouse effect you know color envoy one Q2 Q2, new starts and then a.
Separate question was that duration, what are you expecting for durability.
The durability always think about this as a backbone therapy. So men will beyond this four years not months as they even as they can.
You need to get other therapies. So that's a that's the piece on durability with regard to data, we havent, here's what I would say it you know the Mart, we've we've actually seen this market continue to grow about 5% annually. We haven't seen dips. So what I would say is that its a large market at 300000 with about.
5% growth year over year for the T. prescriptions and that's you know.
I would say that's the best we can comment relative to the data that's available today.
Okay. Thank you.
Thanks, Brian next question please.
Thank you and especially.
About the only dealt with Cowen and company. Your line is now open.
Good morning, Congrats on the progress couple of questions on prostate cancer and one of the actually there was the pipeline first on.
Prostate cancer, one place physicians have thought really goes would fit in perfectly is for those men either on intermittent therapy or who want to be on it.
From an therapy do you have any figures for currently the number of men.
Who are on intermittent therapy and any idea in the trends of the trends and the adoption of that paradigm.
Sure. Thanks, So so as we said earlier, we believe really go looks as appropriate for the broad spectrum.
Jim as men with advanced prostate cancer, but it is absolutely true that the profile is really go like switch with the recovery. After discontinuation of therapy is particularly attractive to many men who have an opportunity to discontinue therapy and you may recall that three months after stopping really go legs, 54% of men had.
As to Australian within the normal range versus 3% in men on Looper lied 90 days after their last injection and so this can be particularly.
Attractive to men, who may have the opportunity for intermittent therapy, which is basically drug holidays. After their PPSA has been controlled and we estimate.
Today about 30% to 35% as men, our oh like receiving intermittent therapy and that is something that could grow overtime.
Perfect. That's very helpful and second on the CV safety benefit do you have any plans to follow up on the signal.
You saw.
In the study and in particular, maybe to a specific CV safety study similar to the one that's completing for digger looks now.
Yeah, that's a it's a great question and that's absolutely something were considering and looking at the feasibility Oh, we have not made any decisions about that at this time, great and then.
Last question actually just on every piece so too.
What are your most recent plans for advancing that do you.
Every five to 2021 to start the next study.
Yeah, we are very excited about and be successful too is you know, it's a novel concept and agonist that we have been developed.
I mean for a female infertility at this point in time, we are clearly in squarely focused on our launches, but we expect that you'll be hearing more about MPT six so two and 2021.
Great. Thanks for taking my questions.
Yes.
[noise] last.
With that operator.
Next question.
Thank you and our next question comes from Paul Cheng with Goldman Sachs. Your line is now open.
Thank you good morning, and congrats on all the progress.
Either for Lynn or for a down can you maybe just talk about what is the current.
Frequency of utilization of Gen. Our H.
Products between medical oncologist.
And the urologist and lug pause and how do you think about maybe threading. The needle. So you don't isolate one population there in terms of promoting promoting your prostate cancer launch.
Sure. Thanks.
Thanks, Paul Adele you want to start.
Sure we.
We believe that there's perhaps a slightly higher rate of our high volumes high volume prescribers that are coming from the urology office, but the medical oncologists are also a very important target audience for us and they are also.
Hi prescribed also high prescribers for this season, we see we see our plans are to adequately educate both of those populations and our sales reps are going to be in there targeting both and I don't see that we'd be.
Distancing one from the other they're both very important prescribers for.
Men with advanced prostate cancer.
Thanks, Adele and then maybe as a follow up just on the with regard to the hero survival data.
Reference earlier your prior market research, suggesting that 60% would be willing of physicians will be willing to prescribe. It can you maybe just provide any updated feedback.
That you may have received from physicians post the survival data and just how they're thinking about.
Utilization in any any changes there. Thank you very much for taking our questions.
Thank you I can just comment.
On the castration resistance free survival data that was presented recently and.
Demonstrated.
Outcomes. Similarly between really got legs, and luper life, while we Didnt show superiority over Lupron light the data were comparable and I think what we found is that the physicians are actually reassured that they can get the benefits of really felt like streetman, including the lower incidence of cardiovascular events with.
Comparable outcomes until we really haven't seen any differences in our research.
About utilization or trust.
So.
Operator, I believe that the the last question.
Im showing no further questions in the queue at this time.
Okay. Thank you.
As you just heard living.
Let me make some closing remarks, if you as you've just heard the next 12 to 18 months are expected to be truly transformational for my event as we look to launch two products in three indications we remain confident in our strategy and our highly motivated by the opportunities before us and.
Prostate cancer and in women's health I look forward to updating you on our progress in future calls. Thank you all for joining us today and for your continued engagement with my it and stay safe and healthy.
Ladies and gentlemen, this concludes my that Sciences second fiscal quarter 2020 earnings call. Thank you for your project.
The patient you may now disconnect.
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