Q4 2022 Myovant Sciences Ltd Earnings Call
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Hi, thank everyone and welcome to the <unk> Sciences first quarter of fiscal year 'twenty 'twenty. One earnings conference call. Today's call is being recorded at this time I would like to turn the call over to unique mirror Chief financial and business Officer at <unk>. Please go ahead.
Yeah.
Thank you operator.
Good morning, and thank you for joining us today to discuss my runs corporate update and review the financials.
Violence fourth fiscal quarter.
Full year 2021.
Joining me for today's call.
Dave Barry <unk>, Chief Executive Officer, Laurie <unk>, Chief Commercial officer, Dr. Juan Camilo, our Chief Medical Officer.
In addition to the press release issued earlier today the slides that will be presented during today's call are available on our Investor Relations website investors <unk> com.
So they may not be happening to our fourth fiscal quarter.
I think the three months ended March 31st turnkey Crazy too.
Fourth quarter or Q2 of this presentation.
We will also have folks who are fiscal year, representing the 12.
Last month ended March 31st 2022, and the fiscal year 'twenty to 'twenty one.
You even this conference call, we'll be making forward looking statements. These include plans and expectations with respect to our broader product candidate strategy. Unfortunately I find themselves.
They can go on.
It doesn't change the risk and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.
Just a question of deep it it can be found in our SEC.
It's going to get done.
In addition, my rent does not undertake any obligation to update any forward looking statements made during this call.
I will now turn the call.
Medics, my wife's Chief Executive Officer.
Thank you unique and good morning, everyone.
Fiscal year 2021 was a transformative year for Mylan.
As we firmly advanced our commercial capabilities and maintain the financial strength to continue growing our brands, while deepening our pipeline for the future.
We're energized by the significant momentum that we've generated and believe miles that is on a trajectory for substantial growth in the year ahead.
We had a strong finish to the fiscal year as we successfully drove commercial demand for both <unk> and my fabric.
For the quarter, we expanded utilization of our globex for men with advanced prostate cancer with demand volume growth of 18%.
Demonstrating continued adoption across a broad range of patient types and treatment settings.
With my February we've already achieved market leadership in new to brand prescription share while substantially growing the generates antagonist class for the treatment of uterine fibroids.
And outside the U S right, yet, though is more widely available for women with uterine fibroids now launched in 17 European countries.
As we close out our fiscal year mildly have recorded $231 million of total revenue, including net product revenues of $94 3 million.
Of that $32 4 million of net product revenues were recorded in the fourth fiscal quarter.
Moving to regulatory and business development updates.
As it relates to our my temporary S N D a for endometriosis associated pain.
The FDA has extended the review period to allow for a review of additional analyses it requested and we provided regarding bone mineral density.
The extended Paducah Gold date is August 6th of this year.
We remain confident in the clinical profile of my temporary and its potential to become a meaningfully differentiated therapeutic option for the management of endometriosis associated pain.
We will continue to work closely with the FDA to support the advancement of our S. N D. A.
We're also pleased to announce the results of our spirit long term extension study of my temporary in women with endometriosis.
We are the only gnrh antagonist stroke demonstrated consistent efficacy and safety profile through two years.
Moving to our oncology business I'm excited to share two important developments.
As we announced in April the European Commission approved or go. This is the first and only oral androgen deprivation therapy for adult patients with advanced hormone sensitive prostate cancer.
And on the heels of this approval, we just announced a highly anticipated exclusive license agreement with a core health care for the commercialization of <unk> in Europe .
Once launched in Europe patients will have the ability to rapidly reduce testosterone without hormonal flare and a convenient oral form.
We believe that overtime will go VIX has the potential to change the standard of care in Europe for men with advanced hormone sensitive prostate cancer.
We entered this fiscal year in a strong financial position.
With cash and committed financing of just over $475 million, enabling us to fully support or go back and like temporary commercialization activities, while seeking to expand our pipeline.
Now, let's review the exclusive license agreement with a court health care that was just announced yesterday.
And of course, we have found the ideal partner with the existing capabilities already in place and importantly, the passion and the commitment to unlock the commercial potential of <unk> in Europe .
Our court is one of the fastest growing pharmaceutical companies in Europe and has one of the largest market footprints in oncology with over 40 oncology related treatments.
We're delighted to join forces with the court to make available or go VIX in Europe as the first and only oral androgen deprivation therapy for men with advanced hormone sensitive prostate cancer.
Under the agreement our corn obtained rights to commercialize our globex in Europe and potentially other select markets.
We're very pleased with the favorable deal economics with a total value of up to $145 million or mild that will receive an upfront payment of $50 million and up to $90 5 million in milestone payments, including $15 million of near term milestones.
In addition mile that will receive tiered royalties from the high teens to mid twenties on that sale.
We're excited with our new partnership with a cord and look forward to European launches of our goldfish beginning later this year.
So as you can see we've had a number of recent positive developments, which positioned biomass for a strong 2022.
Now for a more in depth review of our commercial performance I'll turn the call over to Laura.
Thank you Dave.
Today I'll provide an update on this appointment.
And our progress on my son be launch in the U S.
Let's start with I'll go ahead you wanted.
Well go next showed continued momentum in Q4 further advancing our progress in establishing it as an androgen deprivation standard of care.
Since launching in January 2021.
14500 men have been treated with Argos demonstrating.
Demonstrating continuing growth of patient and prescriber demand.
Well no that's delivered $83 million of revenue for the fiscal year with $29 4 million in fiscal Q4.
We're proud to report that in this quarter.
Thank you, 18% sequential commercial demand growth over the prior quarter, demonstrating the continuing expansion I won't go there.
Well go next to new patient starts grew significantly this quarter with an additional 3500 men initiating on <unk> in Q4, representing a 32% increase compared to last quarter and bringing the total estimated patients treated since launch to 14500.
It's important to note that these patients represent a broad range of patient types.
Lisa analyses of our specialty pharmacy claims data shows that although that is being used broadly.
T naive and transition patients and that was across patients with different stages.
We also see that about 20% of patients have used in combination with other prostate cancer therapy.
It's consistent with combination use in the ADC market overall.
This confirms that prescribers and see the benefit of the encore clinical profile across a spectrum of prostate cancer patients.
In fiscal Q4, we saw 21% quarter over quarter growth of net sales. Despite the typical January seasonality.
Annual resets, the Medicare part D benefit and commercial payer deductible.
When we look at month to month May sell rate there was an impact in January but they returned to normal levels above 90% in February and March.
During the same time periods of new patient starts trend continued and was not impacted by this payer dynamic.
In addition to the typical seasonality there isn't on Alcon surge in January that impacted our access to physicians offices and they have had an impact on patient flow.
Despite these short term dynamics underlying fundamentals of our business remain strong, including the bond covenants, we've established to enable patient access and important leading indicators like the new patient starts trend the breadth of use across patient types, the breadth and growth of account adoption.
And increasing prescribers satisfaction.
The combination of these factors gives us conviction in our future growth trajectory.
Let's explore each of these further.
Just any thought on what it's being used across the breadth of patient types.
Also being used across the range of treatment settings.
About 80% of our business comes from the dispensing clinics and academic and I began accounts combined.
And this is consistent with what we see from the ADP market overall.
Almost half of our volume comes from dispensing clinics.
Primarily driven by urologists.
And the academic segment, primarily driven by oncologists is driving 35% of our business and it's one of the fastest growing segment.
Most importantly, we're seeing double digit growth across all segments with almost 20% volume growth overall.
This demonstrates that our business is well balanced across prescriber and accounts as well as across the spectrum of patients.
A key driver of the growth we've seen to date is a differentiated clinical profile of our capex.
For the first time prescribers have a treatment that provides fast on fast off profound and sustained control of testosterone in a convenient one pill once a day dose.
This profile is unique and compelling and as prescriber experience is growing so as their satisfaction, which has now risen to 73%.
Oh, there's growing prescribers satisfaction, coupled with our growth to date and the breadth of our business gives us further confidence that the growth trajectory for Argo that will continue in the year ahead.
With 300000 men being treated with ADT each year, there continues to be tremendous opportunity for us to expand our impact and establish ourselves as the new standard of care and advanced prostate cancer.
Now turning to the launch update for my family.
Fiscal Q4 was a milestone quarter for my summary, and we surpassed our competitor to become the market leader for uterine fibroid patients new to Gnrh therapy.
Capturing 59% new to brand prescription share.
Over 3400 women had been treated with my family since launch more than doubling the number of patients treated to fiscal Q3, and reflecting the growing momentum we're seeing with this brand.
So I wanted to change the treatment paradigm, it's imperative that we grow the gnrh class.
Since the launch of my family in June of 2021, the total prescription volume for the jammer H antagonist in uterine fibroids.
Loan by 137%.
This demonstrates that my family and expanding the patient population that prescribers believe will benefit from this class of treatment.
In fiscal year, 2020, one we recognized $6 $4 million of net revenue.
With $2 2 million in fiscal Q4.
My friend and commercial demand nearly doubled in Q4 versus Q3, but this growth was offset by a lower net price due to the January resets of commercial payer deductible.
Increase in co pay card benefit.
This seasonality is the dynamics seen across our industry and we expect it to improve in subsequent quarters as patients work through their annual deductible.
The new brand prescription share trend shows how quickly my family has established market leadership in uterine fibroids.
Six months post launch half of patients initiating Jan or each therapy, we're receiving my fabri and within eight months, we surpassed our competitor to become the preferred treatment for these patients.
We attribute this rapid growth trajectory to my family's differentiated clinical profile and our focused commercial strategy, which we believe will continue to expand our market leadership in the future.
My son brings compelling clinical profile and our strategic approach is also accelerating overall growth of the Gnrh antagonist class freedom Fibroid.
On our last earnings call.
To show the Gnrh antagonists market had grown by 81% My Fabri launch and now we're happy to report that both has further expanded to 137%.
Demonstrating an acceleration of adoption of the cloud.
In addition to increasing the overall class volume.
My family is also attracting new prescribers to the class.
Over 1700, HCP and SEC prescribed to date.
60% of these prescribers my family was the first Gnrh antagonist, they had written for uterine fibroids.
Ultimately its class growth that will be reaching far more women, who can benefit from this product and the momentum in the market is showing that my summary is leading the mindset shift that will continue to expand this market over the long term.
From the start we knew that providing a positive first experience for prescribers and patients with essential in this market and that starts with access.
We've now secured coverage for 93% or 165 million commercial lives.
An increase of nearly 17 million lives since January .
With this we can proudly say that we have established broad access well in advance of our expectation.
Well access enables prescribing, it's really my family's differentiated clinical profile, that's driving the increasing momentum around this brand.
My friend, Barry provide substantial and sustained reduction in menstrual blood loss and a convenient one pill once a day dose a profile that is clearly resonating with obgyn.
Nine out of 10 Hcp's are now aware of my Fabri and even more importantly, nearly 90% of our priority customers intend to prescribe my family in the next three months.
This indicates that physicians are finding that my family clinical profile compelling and aligned with their treatment goals.
With 5 million women seeking treatment for uterine fibroids, and 3 million of them being filled by their first line therapy.
We believe there is a tremendous opportunity for my family to make a difference for these women.
Based on our progress to date and the building momentum. We believe that we are poised to evolve this market and ultimately redefine the treatment paradigm and uterine fibroids.
And now I'll turn it over to Juan Camilo to provide our clinical and regulatory update.
Thanks Noel.
Okay.
Thank you Lauren.
As announced last week the F b.
<unk> extended the review period for the my summary, F&B, a poor management of moderate to severe pain associated with endometriosis.
This extension will allow the agency time to review additional analysis at bone mineral density data, we provided upon their request.
No new clinical data was requested by the agency.
The submission of this additional analysis has been determined by the FDA. It constitute a major amendment to the S. M D. A.
Resulting in an extension of what they do for gold dates to August six.
It is our policy not to discuss them going interactions with regulatory agencies. During the review of an application we're not able to provide additional details at this time.
We remain confident in the efficacy and safety profile of my family in women with endometriosis associated pain.
Its potential to become an important treatment option and.
And we will continue to work closely with FDA to support the review of the S. M B a.
Okay.
Now, let me share with you the topline results of the second year of treatment in the spirit long term extension study.
Yeah.
Remember that <unk> combination therapy is the only generate 10 times the areas for which to your efficacy and safety data have been reported.
As you May remember women with moderate to severe pain associated with endometriosis, who participated and completed one of the two pivotal studies spirit, one or two.
All entry criteria were eligible to participate in an eight week extension study in which all women receive robotics combination therapy.
Of the treatment received during the pivotal studies.
Okay.
The co primary endpoints for the long term extension study, where the proportion of responders on dysmenorrhea pain.
Pain.
I haven't done myself pelvic pain or M. P P.
And were assessed at week 52 and week 104.
The fundings were defined as those achieving a mean reduction in their scores greater than or equal to two eight points for dysmenorrhea.
So greater than or equal to one point for <unk>.
No increase in use of analgesic medications.
The initial analysis at week 52 was conducted after all patients have completed 28 weeks of treatment.
Data from this analysis was previously presented and were included in the SBA.
At the end of the first quarter 2022, we completed the second year of treatment, which we are briefly summarize each year.
Therefore at least in your data are not part of the F&B currently under it every year.
As you can see at least 50 to 84, 8% of women, who received <unk> combination therapy continuously somebody's life net debt definition of a responder for dysmenorrhea.
73, 6% met the definition of a responder for M. P P.
And we one or four eight.
84, 8% and 75, 8% met the definition of our cylinder for dysmenorrhea and MTP respectively.
These results demonstrate durability of treatment effect for up to two years.
Okay.
Safety data collected over after two years of treatment confirmed the safety profile of <unk> combination therapy, They reported with no new safety signals identified with an additional year of treatment.
The most frequently reported adverse events remain headache Mesa find guidance and hot flush.
Two additional pregnancies were reported in the variable as combination therapy group during the second year of the long term extension study.
Yeah.
Lastly, as shown by the Orange line bone mineral density remained stable through week, one and four in women treated with <unk> combination therapy. After a minimum run clinical meaningful bone loss observed through week 24.
And women treated with placebo for the first 24 weeks in charcoal.
Small gain was observed up to week 24, which was followed by established station after initiation of <unk> combination therapy after week, one or four.
And women treated initially with <unk> monotherapy for 12 weeks.
In Blue Mountain.
Bone density decreases of about 2% were observed by week 12.
It was followed by stabilization upon initiation of <unk> combination therapy.
And a trend towards recovery observed after week 24.
We are very proud of these results and look forward to presenting them with additional details at a scientific conference. This summer.
Pending the outcome of the F&B a review we plan to submit these data to the FDA in the first half of 2023.
Once the protocol mandated post treatment follow up is completed.
I'll now turn the call over to unique to provide a financial review.
Unique.
Thank you Juan Camilo.
My comments today will focus on the highlights of our financial performance in the fourth fiscal quarter and fiscal year 2021.
Please refer to our press release issued earlier today for additional information.
Let's begin with revenue.
<unk> recorded $57 $6 million in total revenues in the fourth quarter.
Q4, net product revenue was $32 4 million.
Global net revenue was $29 4 million, reflecting 18% sequential demand volume growth and net price sensitivity.
The gross to net deduction for <unk> and.
In fiscal fourth quarter.
And at least 40%.
We expect our.
Gross to net to being the low to mid 40 percents for the foreseeable future.
My family based revenue was $2 $2 million for fourth quarter, reflecting nearly doubling.
And the commercial demands while you compare to Q3 offset by a lower net price driven by higher co pay card benefits.
We recorded $25 $1 million of Pfizer collaboration revenue consisting of <unk> 1 million related to the partial recognition of the upfront payment received from Pfizer and $4 1 million related to the partial recognition of a $100 million European fibroid regulatory milestone payments.
In future quarters, we will continue.
These milestones as the same amounts through the end of calendar year.
Sixth Wednesday amortization.
Amortization is scheduled to end.
For the fiscal year 2021, we recorded $31 million of total revenue.
Net product revenue was $94 3 million consisting of net revenues for the status of our holdings of 83 million <unk> of $6 4 million in existence product supply and royalties excitement.
For the fiscal year. Thank you. Thank you run Pfizer collaboration revenue was 105.
$8 million and consisted of $83 9 million related to the upfront payment received from Pfizer and $21 1 million related to the uterine fibroids makes me milestone.
For the fiscal year 2021, we also recorded $31 $7 million of license and milestone revenue from Gideon Victor.
<unk> also 15 million regulatory milestone and save money for the European Commission approval for I Echo for European Fibroids, and $16 7 million related to the remaining portion of the upfront and initial milestone payment.
Moving on to other highlights of our income statement.
Cost of product revenue for the fourth quarter and fiscal year 2021 was $3 6 million $11 $5 million, respectively, largely comprised of expenses related to the cost of goods sold as well as the royalty unless in Pennsylvania.
With a decade.
Collaboration expense for the fourth quarter and fiscal year 2021 was $14 1 million and 40 million respectively.
Reflecting fight her 50% share of net profits from sales of our vortex and my family in the U S.
Yeah.
R&D expense in the fourth quarter was $24 5 million compared to $21 6 million plus the compatible variety.
The increase in R&D.
<unk> expenses.
Reflecting the increase in expenses associated with the hiring of my legs Medical Affairs organization and other personnel to support the U S launches of our <unk> and <unk>.
For fiscal year, 2021, R&D expense was $174 million compared to $136 7 million for the bad.
The decrease in R&D expenses.
Like a reduction in clinical study costs as a result of the completion anyway.
<unk> phase III clinical programs.
Okay.
SG&A expense in the fourth quarter was $67 $2 million compared to 78 million for the comparable right.
The decrease primarily reflects lower share based compensation, partially offset by increased spending on <unk>.
Motion activities to support the U S launches of our Colgate and my family.
For the fiscal year do you think you've gotten as G&A expense was $259 $4 million compared to $1 $81 4 million for the prior year, reflecting higher expenses to support the U S launches of our overextend myself.
Myelin generated a net loss of $59 3 million in the fourth quarter and $206 million for fiscal year 2021.
On a per share basis net loss was 63 cents for the quarter and $2 nine defense for the full year.
Looking ahead, we expect fiscal year 2022, R&D expenses to increase as compared to fiscal year 'twenty JQ, one driven largely by anyway.
Lifecycle opportunity.
The phase III setting study.
Well as a post marketing requirements as agreed upon with the FDA.
SG&A expenses in fiscal year 2022 are expected to increase.
For fiscal year, 'twenty, one with increased marketing and promotional expenses to support the ongoing commercialization of our robotics and my family in the U S, including annualized nation of the my friends in marketing and promotional spend and targeted patient activation for both brands.
We ended fiscal Q4 with total cash marketable securities and committed financing of 475 $5 million.
Write offs for taking $4 2 million of cash and marketable securities and $41 3 million of capacity remaining under the low cost loan facility extended doors by Sumitomo pharma.
The Oregon shareholders.
Additionally, we expect to receive an upfront payment of $15 million from accord healthcare in the first quarter of fiscal 2022.
This coupled with additional potential future milestone payments shedding of certain relevant mix related development and commercial expenses at Pfizer as well as the anticipated increase in <unk> and my friends via seven years plus.
My lab and an excellent financial position to successfully execute our commercial strategy, while at the same time expanding our pipeline.
I will now turn it back over to Dave for some closing remarks, Dave.
Thank you unique one camilo and Lauren.
We believe mile Dan is positioned well for near term and long term sustainable growth.
We have two differentiated brands and markets with high unmet needs demonstrating substantial demand growth and supported by our strong collaboration with Pfizer in the U S.
Outside the U S. Our partnership with Gedeon Richter, coupled with our new partnership with a cord will continue to expand our patient impact globally.
Our strong balance sheet allows us to maximize our launches while enabling targeted investment in pipeline opportunities.
And looking ahead, we remain confident in our S. M. B a from my temporary for endometriosis associated pain.
And look forward to working with the FDA to potentially bring this meaningful therapy to patients.
In addition, we have multiple opportunities to expand our global reach in both women's health and oncology and.
And later this year, we intend to share details of potential new pipeline programs.
Thank you for your attention and I'll turn it over to the operator to begin the Q&A session.
At this time, if you would like to ask a question. Please press star and one on your Touchtone phone you may remove yourself from the queue at any time by pressing the pound key once again that is star one if he would like to ask a question. We do ask that you. Please limit yourself to one question and one follow up.
Take our first question from film that deal with Cowen and company.
Good morning, Thanks for taking my questions. First question is commercial you've called out seasonality for both for <unk> and my February but curious if you can quantify the impact on reported revenue.
Of the seasonal factors how much of a.
Dollar size headwind was during the quarter to those seasonal factors.
Yeah.
Yes, good morning, Bill Thanks for joining us.
We haven't really put.
The map on specifically, calling out what part is seasonality versus just general trends that are happening based on seasonality. So we did see significant demand growth as we've mentioned.
Across both or go VIX, and my memory, and so our patient volumes and new starts continue to grow a little bit of the economics as it relates to pulling through on the revenue was clearly impacted to some degree by.
Copay cards et cetera that were mentioned.
But we're really encouraged by the overall continuum.
Generation of demand that we're seeing that's very consistent with prior quarters.
Okay Fair enough and then I guess, a follow up which is somewhat unrelated.
S N D E and endometriosis I know you said you didn't want to go into much more detail on the interactions, but you have disclosed that.
<unk> identified deficiencies and you've disclosed that you've submitted analysis in bone marrow density. So I'm curious if you can give us any more information on either the deficiencies that were indicated by the FDA or exactly what your analysis there.
Thanks for your question.
Yeah, Juan Camilo, you want to take that.
Yeah, Hi, Phil.
As we mentioned in our in our prior call. The FDA didn't specify in the first letter what deficiencies, where they were referring to.
And then as part of our ongoing.
Reviewing the discussion with FDA as part of their review we received their request for.
Additional D&B analysis on data they already had because we just provided those analysis right.
We don't know how those two are really are related and FDA has not communicated more detail put back to us.
So you still actually haven't been specifically informed of the deficiencies that do you have to your risk front.
No we have not received a specifics beyond the request for the additional analyses that we received.
Got it thanks for taking our questions and congrats on progress.
Hey, Thank you Phil.
And we'll take our next question from Brian Snarky with Baird. Your line is open.
Hey, good morning, everyone. Thanks for taking my question I.
I have a question on the accord healthcare deal just interested in hearing a little bit more about the capabilities here it seems but they're largely a generics company I was wondering do you know how many branded drugs that they have on the market that are that are branded exclusive.
And I know, it's a bit of a different market, but I think they just launched a leuprolide brand in the U S. So I was just curious if you know if they had any intention of launching that in Europe , and how how you know.
That sort of efforts in prostate cancer in the U S drove if at all your decision to partner with them.
Yeah, well I'll take part of that and then I'll turn it over to Loren.
Yes, certainly.
There we are very impressed with their footprint in oncology. The brand that you mentioned is a U S brand and not currently available in Europe could.
Could be available down the road, but right now we are looking at really having a priority our role within their oncology portfolio, which is really exciting Lauren do you want to talk about their portfolio.
Yeah. So they have currently has six branded products across three.
Areas with oncology being the primary focus and I'll just add to today's call.
Comments, you know they have tremendous reaching Europe with 95% of the Europe , reaching 95% of the European population and with their with their experience already in prostate cancer. It made them a really desirable partner Oh go ahead.
Alright, thank you.
Thank you.
We'll take our next question from Eric Joseph with Jpmorgan.
Hi, good morning, Thanks for taking the questions. So just one on <unk> commercial.
Curious.
No. If you have a sense of what the duration of therapy is among the legacy patient. So I guess those that were new to brand calendar Q1.
I guess any insight on disputed potential discontinuation rate.
I guess, what can be done to shore things up there and I guess with now having a little bit over a year's worth of experience into launch.
Are you in a place where you are.
Might be able to.
Or start providing guidance for full year.
And then one modeling question a diversity of court deal can you just clarify how you're going to see.
Reflecting the <unk>.
<unk>.
The $50 million milestone payment.
Yes.
Thank you.
Well good morning, Eric I'll start with Laura if you could take the discontinuation rate for aerobics and then the other two questions for you unique Laurent.
Thanks, Eric for the question.
So from a duration of therapy perspective.
It can be challenging packaging now with <unk>.
The limitations of our of our data, but also with the different ways that physicians utilize ADT.
So of course, it can be used as a long term therapy in which case, we do not have the power of the data yet so any estimation at this point would be an underestimation, but also some physicians use.
ADT product intermittently or can you use it in the case of radiation for any short shorter duration. So between the limitations of our data the time on market and the variable.
The ability and the way that our products are used it's very difficult to be able to get our duration of therapy estimate at this point.
And you have unique you want to cover the guidance and how we will record the upfront yeah. Thanks for the questions on the guidance for a rig.
I think we're seeing impressive growth both on new patient starts as well as on the demand.
The broad accounted option as well.
Still relatively early despite us know hasn't always been giving guidance on the gross to net to give formal guidance on the overall revenue numbers I think we would need a few more quarters under our belt to be able to do that.
I think to your question on the accordion milestone so the $50 million, we expect we havent finalized the revenue recognition with our auditors as yet, but I think given the service obligations under <unk>. We do expect the majority of that revenue can be recognized in fiscal year. 'twenty then can do.
Okay, great. Thanks for taking the questions.
Okay.
We will take our next question from Matthew Kumar with Goldman Sachs. Your line is open.
Hey, guys. Thanks for taking my question. This is Rob on for Madhu I was just wondering for that I know.
Joseph Paducah do you do any of the bone mineral density questions from the FTA affect the current approval and U S.
I'll add one comment I'll take that yeah, hi, Rob.
The request for additional analysis of our to inform their review of the endometriosis.
He ended pain indication.
We've submitted.
So we will continue to work with the FDA on that review and an end.
Look forward to the next steps with them.
Now in Olympics.
Yeah.
Okay. Thanks.
We will take our next question from Mariana Perez with SVP Securities. Your line is open.
Hi, Good morning, a couple for me.
Cargo mix could you remind us how the gross to net dynamic evolves Francisco three Q4, Q and are you seeing any signs of stabilization or can it still increase into the next couple of quarters.
Yeah, and I can take that question good morning.
I mean, typically Q3 and Q4 I mean, largely we've seen approximately 40% gross to net.
Although rig and this is consistent with our guidance.
Given that it's around the low <unk> to mid Forty's and Thats. The same we expect for the coming fiscal year. So we I think the remaining the debt guidance on gross to net.
Okay, great and still on VIX I wasn't sure if I missed it what has the reorder rates looked like in the recent quarter and I noticed you mentioned Theres a little bad recent gorilla among academic or oncologist prescribers, just curious what what might be driving that as well.
Yes, I'll turn it over to Loren here in just a second I think with the academic.
We're very happy with that one with the growth that we're seeing across the different treatment settings.
With the academic and IBM.
As we May have mentioned that we see are predominant.
Use with oncologists in that setting so when we think of those within office dispensing that we mentioned that's largely urologists, where this section is largely oncologists. So we're really happy to see substantial growth in both of those largest section sectors, which combined make up about 80% of our overall volume.
And good morning.
Yeah.
From the perspective of reorder rates, what I'll say is when we look at the top 50 accounts for ADT volume.
I'll take the accounts are currently using or go back and all of them are are ordering on a regular basis. So on a monthly basis. So we see high reorder rates and our biggest customers.
And that's really where we're focused.
Okay, Great and last one for me for my Sundry I was curious.
How near peer interactions gone so far and are you exploring extra rebating strategies and to help get preferred status things like that.
Martin.
Yeah.
No.
Obviously, we've made great progress on the payer front in our discussions to date and establishing our payer coverage.
Much quicker than we expected.
Actually so.
Those discussions have gone extremely well.
We've been very careful around.
Rebating strategy, then and.
We've tried to establish parity coverage that has been our goal from the beginning and that.
That that's where we've been successful.
The danger is going down the rebating balances, but it becomes a competitive race to the bottom. So I'm, we're not looking to start that but rather to be competitive and then we believe our clinical profile.
Uh Huh, that's come out on top as you've seen from the MD Rx data.
Saying out as we expected.
Yes, another point of reference Ruana, when you think of the step through that some payers require a step through oral contraceptives and remember there are 3 million women with uterine fibroids who've already been failed by their first line therapy, which is typically uterine fibroid. So while we could spend a lot of time trying to take that away.
There are so many women who are already who've already stepped through those the initial therapy anyway, and so now it's really how do we capture those women that have already been through either Unfortunately, many times, one or two courses of oral contraceptives. So there is still tremendous headroom for us.
With our current contracting strategy and we don't see that as the as.
What's getting in the way, it's really making sure that obgyns understand the outstanding coverage that we have and the outstanding co pay assistance that Lauren and her team are putting in place.
Got it thanks.
And once again that is star Antoine if people would like to ask a question. We will take our next question from Gavin Clark Gunther with Evercore ISI. Your line is open.
Yeah. Good morning, Thanks for taking a multipart. So we've heard from a prescriber calls with their strong interest in using I'll go back in combination with the second and third Gen blocks.
A considerable market opportunity, but theres still some hesitations over the lack of data generated to date. So I'm trying to ask about the development status here and one actually doing a phase one trial you sponsored.
Bermuda and Abiraterone combos wondering and you can see that from the secondary issue. There's a janssen sponsored phase two also testing or beta plus or <unk> wondering what your involvement in this trial and thirdly I just wanted to hear any next steps on the ADP combo program, including potential extended coupon relation pleasure. Thank you.
Okay, we'll see if we can get through those.
<unk>.
We will not miss any of those parts of that.
Of those I think let me kick off just by saying the combination therapy data that we do.
As discussed earlier today, where we have around 20% of our patients that we're estimating our on combination therapy. So when we look across the ADT broader market that seems to be about consistent now we acknowledged thats not a huge sample size its market research that that we're looking at the claims data, but at least right now it feels.
Like we are in the neighborhood of what ADT therapy utilization would be in combination.
Regarding generating additional combination information I'll turn that over to Juan Camilo.
Hey, John and good morning.
For a combination therapy.
<unk> therapy data, we have multiple choices.
He presented are in the process of publishing data from our hero study, where patients who had progressive disease were allowed to take and below the mine <unk> or docetaxel and we have a fair number of those that will will be have been presented and will be published relatively soon.
We are as you pointed out running our phase one study in which we are exploring.
Transition efficient that are already on.
ADT pause.
Abiraterone, Buda mind or Docetaxel in three different parts of the study and then transition their ADT to our growth rates and we're following them. Initially for 12 weeks and then after a year. Afterwards. So we are very excited about that program and we look forward to reporting our results of that study later this year.
By far basis, as we complete those projects.
With regard to the to the Janssen study we are not directly involved in that study, but we are excited to see that other companies are.
See the value of using <unk> as their ADT of choice for their drug development programs for the asset.
And in terms of co formulation would extend your other drugs. We are as you know.
Very interested in looking at all potential of pipeline opportunities and opportunities, particularly with <unk>.
So this is one that we are exploring among others.
But we don't have anything else to report at this point.
Thank you Kevin.
And we have no further questions at this time I will turn the program back over to Steve Merrick for any additional or closing remarks.
Well thank you.
Look fiscal year 2021 has been really a transformational year for mile than as we evolve into a successful commercial stage company.
And we will use the momentum from 2021 and these recent positive announcements as catalysts for further advancement of our business and we're on a trajectory for substantial growth in the year ahead. So thank you for joining us today and I look forward to keeping you updated on our progress have a great day.
This does conclude today's program. Thank you for your participation you may disconnect at any time and have a wonderful day.
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