Q1 2022 Myovant Sciences Ltd Earnings Call

[music].

Good day, everyone and welcome to my of then Sciences first quarter of fiscal year 'twenty 'twenty..1 earnings conference call. Today's call is being recorded at this time and I would like to turn the call over to Ryan <unk>, Vice President of Investor Relations at My event. Please go ahead.

Thank you operator, good morning, and thanks for joining us today to review the financial results of my events first quarter of fiscal year, 2020, 1 and to discuss other corporate and business updates.

Joining me for today's call are Dave Marek <unk>, Chief Executive Officer, Frank Carbo, President and Chief Financial Officer, Laura and Marin Dino Chief Commercial officer.

And Dr. Juan Camilo Arcana, Chief Medical Officer.

In addition to the press release issued earlier today the slides that will be presented during today's webcast are available on our investor relations website investors that mild and dot com.

Today, we will be referring to our fiscal first quarter, which ended on June 30 of 2021.

That's our first quarter or Q1 throughout this presentation.

During the course of this conference call, we will be making forward looking statements. These include plans and expectations with respect to our products product candidates strategies and opportunities and financials, all of which involve certain assumptions of the risks and uncertainties that are beyond our control.

Control and could cause actual results to differ materially from these statements and.

Discussion of these risks can be found in our SEC disclosure documents and addition, might've asked does not undertake any obligation to update any forward looking statements made during this call.

I'll now turn the call over to Dave Marek <unk>, Chief Executive Officer.

Dave.

Thank you Ryan and good morning, everyone.

<unk> 2021 fiscal year is off to a strong start marked by accelerating commercial momentum and the U S and significant regulatory achievements that will enable us to bring our differentiated therapies to more and more patients.

And our first quarter mile of AMT recorded $41.1 million of total revenue, including $11.6 million of product revenue and $29.5 million of Pfizer collaboration revenue.

During the second quarter on the market for <unk> achieved revenues of $10.5.

And $5 million.

Reflecting strong sequential growth quarter to quarter.

This continued growth reflects increasing enthusiasm from clinicians regarding the differentiated clinical profile of <unk> as well as increased payer coverage.

We're also pleased with the FDA.

And June launch of my memory as.

As the first and only once daily oral treatment for women with uterine fibroids.

We achieved revenues of $1.1 million, reflecting initial inventory stocking by distributors.

We and Pfizer conducted of simultaneous launch.

Launch and remain excited to bring the differentiated profile for the millions of women battling uterine fibroids, where high unmet need remains.

From a regulatory standpoint, we've achieved several significant milestones over the past few months.

In addition to the FDA approval of <unk>.

The European Commission also approved re echo the European brand name for <unk> combination tablet.

The commercial launch of <unk> is expected to begin in the second half of this calendar year and will be executed a guinea and rector my events commercialization partner for <unk> and Europe.

The approval of <unk> is notable for a couple of reasons.

Not only as of the first once daily oral treatment for women with uterine fibroids approved in Europe.

It's also the first treatment that does not and have a limitation on duration of use.

Recall that our European regulatory submission included 2 year of bone mineral.

And density data from the phase III Liberty randomized withdrawal study.

And as those data were not available at the time of our FDA submission.

We do intend to submit the 2 year and BMD data to the FDA later this year for potential inclusion and the <unk> label.

Also from my memory.

<unk> and early July we submitted a supplemental NDA and the U S seeking approval for the management of moderate to severe pain associated with endometriosis.

And finally and response to the FDA partial clinical hold regarding the phase III of Serene study for my memory to evaluate the prevention of pregnancy.

In July we provided the FDA with and amended study protocol.

Where we are incorporating the MD monitoring as well as modifying the study population per their guidance.

To better support the prevention of pregnancy claim and women for whom <unk> is indicated.

Following further discussions.

<unk>.

We expect the partial clinical hold to be lifted next month.

Turning to business development and intellectual property update.

Mylan and Pfizer recently agreed to extend the timeline for Pfizer's decision regarding its option to acquire a development and commercialization rights to.

<unk> with Alex and oncology and Europe, and other international markets.

And at the end of October.

In June we also took another step and protecting our intellectual property as we were issued a new methods of treatment patents.

And which could expand the exclusivity period for my summary, and uterine fibroids.

This patent joins to other methods of patents previously granted for <unk> for treating advanced prostate cancer, all of which are now listed and the FDA Orange book with exploration and September of 2037.

And finally, we continue to be on and excellent financial position.

And <unk> with cash and committed financing of over $600 million as of June 30 <unk>.

Excluding of $115 million of recently triggered regulatory milestone payments from Pfizer and Richter.

We're excited about the opportunity that we have with my family to redefine care for women with.

Uterine fibroids and we continue to be encouraged by the continued launch momentum for <unk>.

Now for a more in depth review of our commercial performance I'll turn the call over to Lauren.

Lauren.

Thanks, Dave.

Today I'll provide an update on the early progress.

And I mean, and the launch of my summary, followed by an update on the Arizona ex launch.

And my Thunder was approved by the FDA and late May and as the first and only once daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids and pre menopausal women.

We believe my family has the potential to be of truly meaningful advance and women's health and could be kind of the standard of care and medical treatment for women with uterine fibroids.

The unmet need and uterine fibroids is enormous.

Approximately 5 million women and the U S have sought treatment for symptoms.

The user feedback.

On the women, 60% of sales by first line therapy, typically oral contraceptives, which are unable to control the most challenging and Kevin.

Even the 2 out of 3 women prefer and medical option versus surgery.

Ultimately 250000.

And women per year, and the U S make the difficult choice to undergo a hysterectomy for relief from their uterine fibroids.

Mylan and Pfizer are United and our goal to provide these women with and effective well tolerated and convenient medical option.

We believe my family aligns well with physicians.

And David treatment goal of meaningfully improving heavy menstrual bleeding and other challenging symptoms with minimal side effects, and then easy and convenient dosing regimen.

My family has the potential to redefine care for women with uterine fibroids, because it makes the treatment needs for this market.

And the Liberty clinical trial program, My summary, and demonstrated sustained and meaningful reduction and menstrual blood loss.

Hot Flash and particularly bothersome side effects occurred and less than 11% of my summary, patient not meaningfully different and the approximately 7% of patients.

And is treated with placebo.

And the Liberty clinical program, the average decline and lumbar spine bone mineral density at 12 months was under 1%.

However, due to the risk of continued bone loss and the duration of use and the FDA label is limited to 24 months.

Finally.

And finally my family achieved all of this and <unk>.

1 small pill taken just once a day.

The Mylan and Pfizer of commercial teams have worked collaboratively to meet the operational milestones required to position <unk> for a differentiated launch.

Before launch we initiated engagement with key payers.

To support timely access.

And we've accomplished a lot within the first few weeks following approval, including activation of the <unk> website.

Fully stocking in the distribution channel.

Activating patient support services.

And beginning and person field force engagement.

Morris.

Wait and July we began offering starter packs for certain prescribers, who have identified patients to initiate on my family therapy.

All of these steps were taken with the intent of ensuring a positive first experience for providers patients and payers the hallmark of our launch strategy.

The mining and Pfizer sales teams have already conducted more than 20000 and sales calls and the first 5 weeks since our launch.

With nearly 90% of these interactions being and person, reaching over 60% of our high and medium priority target prescribers.

This activity has improved.

Fairness among potential prescribers from approximately 30% prelaunch for nearly 50% as of July.

This early in launch patient experience is just beginning and we are encouraged by the approximately 100 patients that have enrolled and my summary patient support services.

Additionally.

8 of the way over 150 patients have been identified by prescribers as candidates for starter packs and just the first 2 weeks since launching the startup program.

Obtaining payer coverage for my family is among our top launch priority.

We anticipate that approximately 85% of patients.

And that could be prescribed my fabri are commercially insured.

The remaining 15% of potential patients primarily include Medicaid or cash patients.

As of July 1st 37% of commercial lives were eligible for pre review coverage for my summary.

And we believe my family is well positioned to establish access that supports prescriber choice and minimize out of pocket cost per patient.

The certain payers, we have already made significant progress and believe some initial coverage decisions could be implemented as early as August.

We.

We believe my summary of addresses the needs of providers and patients with its clinical profile and convenient 1 pill once a day dosing.

We are excited about the progress that we've been able to make and the early days of launch and we'll be bringing a new and differentiated treatment option for women with uterine fibroids.

I'd now like to discuss the continued progress we've made on the on Globex launch.

Although this launch momentum continues to build as we and Pfizer and work towards redefining care for men with advanced prostate cancer.

6 months following our launch we estimate that over 4500 men have.

Weighted with all go back reflecting steadily increasing adoption.

We recorded $10.5 million of our <unk> net product revenues in fiscal Q1, reflecting substantial demand driven growth compared to fiscal Q4.2020.

Monthly.

And have been traded cumulative patients on therapy, which includes both patients on free and commercial drugs have increased every month since launch, culminating in June where we estimate that over 4500 men have been treated with <unk>.

And May and June we estimate that approximately of 1000 patients initiated although.

Estimate therapy, and each month, reflecting a consistent and gradual trajectory that we've seen since launch.

It's important to note that since launch of approximately 1 third of patients treated with Argo and receive free drug utilizing either on our free trial bridge or patient assistance programs.

Although.

Although visibility into patient level data is incomplete.

Estimate that approximately 60% of patients that started on globex, where previously naved the androgen deprivation therapy.

Additionally, we believe that although this is being utilized and treat patients across the spectrum of the advanced prostate cancer, reflecting our.

1 of them is an FDA label and the therapeutic appeal of the on <unk> clinical profile, regardless of patient types.

As we have discussed before there of clinical economic and operational considerations that can play a role and ADT treatment decision.

Since launch.

We have been actively engaging with prescribers to drag on <unk> awareness and build recognition of its differentiated clinical profile.

And the first 6 months of launch my event and Pfizer have conducted over 42000 and sales calls.

And with over 13000 providers and.

Including reaching nearly 90.

A broader sense of our highest priority target prescribers.

As the launch has progressed and COVID-19 restrictions on in person and detailing has eased the volume and quality of our engagements with health care providers and other practice personnel has increased significantly.

In June.

And 97.5 per cent of Mylan, and Pfizer sales engagements, where and person which is up from 38% in February.

We remain optimistic that we can maintain or increase this level of in person detailing and the second half of 2021.

These sales efforts are delivering results.

And we'll go next share of voice continues to dominate the Gnrh class and was nearly 50% and Jim.

Our recent market research indicate near Universal aided awareness amongst target prescribers with 82%, indicating that they are knowledgeable about the <unk> clinical profile.

We have also successfully broadened the base of prescribers to approximately 1150 treatment centers through June and increase of approximately 300 of 50 and just the last 2 months.

The reorder rate also remains high with 80% of practices reordering or go back at least 1 up.

And from 75% at the end of April.

Finally, our market access team has worked diligently to enable E prescribing and as of early July. Although this was available across all of the EMR systems utilized and practices that we are actively targeting up from approximately 60% at the.

The end of April.

Utilizing data from our patient support hub and specialty pharmacy network, we estimate that approximately 56% of all <unk> prescriptions have been written by urologists and 40% by oncologists.

This early trend is in line with the 2020 patient claims.

Of the ADT class.

And as expected and the vast majority 75% of the although the commercial volumes have been shipped via the specialty distributor channel, which serves practices and institutions with dispensing capabilities, such as large urology group practices hospitals academic.

Centers and integrated delivery networks.

The specialty pharmacy channel, which serves patients of practices that do not have and office pharmacy capabilities.

Distributed the other 25 per cent of or Globex commercial volume and is expected to remain the smaller channel for our aerobics going forward.

We have also made notable progress.

Data and building commercial and part D coverage for <unk>.

As of July 1st we have coverage for over 150 million total lives and increase of 49 million lives since may 1st.

Let's take a look at the progress we've made since may.

On the commercial side, although the ex coverage expanded.

Progress 20 percentage points to 63%, adding $36 million incremental covered lives since may 1st.

Plans that cover 28% of commercialized have yet to make a 2020.1 coverage decision, but are expected to do so in the coming months.

We have made even greater.

Later progress with Medicare part D.

Where we achieved coverage for both of its for 78% of lives as of July 1 and.

And increase of 27 percentage points for 13 million lives since the beginning of May.

Plans that cover the remaining 22% of part D lives may implement coverage decision.

And it by this year with some of these plans potentially deferring or goes ex coverage implementation to early next year.

Importantly, all payers contracted to date have agreed to cover or go of VIX. According to our FDA approved prescribing information.

In closing, we continue to make tremendous progress.

And later all areas of our gold ex launch and has built great momentum and the prostate cancer community.

As we look forward with in person engagement, increasing the impact of clinician engagement.

And improved commercial and part D coverage for patients, we believe that prescribing momentum will continue to steadily build and.

Across the ex will make a difference and the lives of many more men battling advanced prostate cancer.

I will now turn the call over to Frank to review our financial results.

Thank you Lauren.

And as usual I will focus my comments on the highlights of our financial performance and the quarter and refer you.

Our press release and form 10-Q issued earlier today for additional information.

Let's begin with revenue.

My of recorded $41.1 million of total revenue for the first fiscal quarter ending June 30 of 2021.

Composed of $10.5 million.

And they'll go and $1.1 million of net product revenue from <unk> and my fingers, respectively as.

Well as $29.5 million of Pfizer collaboration revenue consisting of $21 million related to the partial recognition of the upfront payment received.

And we see from Pfizer and December 2020.

And the 8.5 million related to the partial recognition of a 100 million regulatory milestone payment that was triggered upon FDA approval of my family.

And future quarters the.

The Pfizer upfront payment will continue to be amortized at the rate of $21 million per quarter.

And the my February uterine fibroid FDA approval milestone will be amortized of the $4 million per quarter through the end of calendar year 2026, when the amortization period is scheduled to end.

For fiscal Q2.2021, we also expect to recognize.

Approximately $31.7 million of license and milestone revenue from our collaboration with Gedeon Richter.

Comprised of the 15 million of regulatory milestone for the July 2021 European Commission approval of <unk> for uterine fibroids and.

And $16.7 million related to the remaining.

<unk> portion of the upfront and the initial milestone payments.

Moving on to other highlights of our income statement.

Cost of product revenue for the quarter was $1 million and largely comprised of the high single digit royalty on net sales of for Covid payable to Takeda.

And to a lesser.

Expenses related to the cost of goods sold for gold and my family.

Collaboration expense was $5.3 million, reflecting pfizer's, 50% share of net profit from the sales of the globex and my family and the U S. During Q1.

Yeah.

R&D expenses in the.

The first quarter with $30.9 million.

Compared to $44.2 million for the comparable prior year period.

The decrease and R&D expenses was mainly driven by cost share reimbursements from Pfizer.

As well as a reduction and clinical study costs, resulting from the completion and wind down of my of <unk>.

Phase III Liberty hero and spirits studies.

The decrease also reflects lower regulatory expenses in Q1.2021 as the prior year period included NDA submission fees for <unk> and my family.

These decreases were partially offset.

Primarily by higher expenses incurred by May of <unk> Medical Affairs organization, which was build out and recent quarters to support the aerobics and my friend Relaunches.

As well as increased study costs related to really the lifecycle management activities.

SG&A expenses and the quarter was $61.2 million.

Compared to $22.8 million for the comparable prior year period.

The increase was primarily due to higher expenses related to commercial activities to support the U S launches of <unk> and my family.

And higher personnel related costs in connection with the hiring of my of its commercial operations marketing.

<unk> and market access teams as well as the oncology and women's health sales forces.

My haven't generated a net loss of $61.7 million of 67 per share and the first quarter of 2021 compared to a net loss of $32.9 million or <unk> 37 per share.

And the prior year quarter.

Yeah.

Looking ahead R&D expenses for the remaining fiscal 2021 quarters are projected to be modestly lower than Q1 actual spend.

SG&A expenses for the remaining fiscal 2021 quarters.

Expect it to increase modestly from Q1 actual spend.

We ended the fiscal Q1 with total cash and committed financing of $611.1 million.

Comprised of $569.8 million of cash cash equivalents in marketable securities.

And $41.3 million of capacity remaining under the low cost non facility extended to us by Sumitomo Dainippon pharma on a majority of shareholders.

This balance does not include $115 million of recently triggered milestone payments from the regulatory approvals of my Fabri and re echo.

We received the $100 million milestone payment from Pfizer and July 2021, and expect to receive the $15 million milestone payment from Victor and second fiscal quarter of 2021.

Yeah.

Our cash position and potential future milestone payments over the next 12 months.

Coupled with the sharing.

Certain expense with Pfizer and the anticipated increase and <unk> and my family of revenue puts my event and an excellent position to execute our commercial strategies while.

While at the same time, expanding our pipeline through future rarely go ex lifecycle of programs and business development.

I would like to wrap up with a bit more color on the recent developments pertaining to our intellectual property associated with really go on.

Which we believe could extend U S marketing exclusivity for both <unk> and my family into late 2037.

Significantly expanding the value of the rally go the ex franchise.

Depicted here is a subset of the patents listed on the FDA Orange book for each product.

Each product has 3 listed patents relating to the composition of matter of case, which we have highlighted previously.

The Gray bar on the first compensation case indicates that we of supply for patent term extension.

Currently pending a decision from the FDA and USB T O.

We expect to receive the full 5 year term extending of the rally the species patent to January 2029.

The more recent development pertained to method of treatment patents, which represent the culmination.

1 of the use of research and innovation.

All 3 of these patents expire in September of 2037, potentially extending the U S marketing exclusivity for these products.

The 2 methods of cases for our globex cover among other aspects of the particular dosing regimen for <unk>.

The methods patent for my family was issued last month and covers the use of our unique relative <unk> combination tablet to treat the FDA approved us relating to urine fibroids.

Among others. We have also filed the patent application, which is current depending on our next anticipated indication for my family relating to.

For the treatment of endometriosis.

Now with that I'll turn it over to Dave for some closing remarks, Dave.

Thank you Frank and Lauren.

The approval and launch of my memory represents a significant milestone and expanding the treatment options for women with uterine fibroids to include.

For the first time of 1 pill once a day regimen with the clinical profile of that prescribers and patients have long desired.

We're encouraged by the early progress that we've made with my <unk> launch and look forward to delivering this important new medicine to patients.

We're also excited about the launch momentum that we've been able to generate for <unk> through our strengthened prescriber educational efforts and increased payer coverage that we achieved over the past few months.

In addition to continuing to execute on the organics and my February launches and the remainder of 2020.

1 will bring several other important milestones.

By the end of October we expect Pfizer's decision regarding its international option for <unk> rights and oncology.

And the second half of the calendar year, we expect Gideon Richter to launch by Echo and Europe and to submit the European filing.

And for endometriosis.

We also expect to submit our randomized withdrawal study results to the FDA by the end of the calendar year, which will include 2 year bone mineral density data.

And looking further ahead into the calendar year 2022, we expect a European Commission decision.

And on our advanced prostate cancer filings.

As Frank highlighted we continue to operate from a position of financial strength.

Which gives us the flexibility to sufficiently fund our U S product launches, while simultaneously expanding our pipeline through <unk> lifecycle opportunities.

And the business development opportunities.

I am extremely proud of the passion and the work done by our mild and team to enable us to deliver on our mission to positively impact the lives of so many men and women.

Thank you for your attention and I will turn the call over to Ryan to begin the Q&A session.

Thank you David operator can we now please poll for questions.

Secondly, and as a reminder to ask a question Brett Star 1 on your telephone keypad.

To withdraw your question press, the pound or hash key.

We have a question from the line of Jason Butler with JMP Securities. Your line is open.

Thanks for taking the questions and congrats on the progress.

For the first 1 for me just in terms of the my phone for a launch.

Can you just give us a sense I know, it's early of what number of prescribers of your target prescribers.

So we're actually already writing prescriptions.

And whats the feedback youre getting from from the initial interactions in terms of what docs would need to start writing prescriptions is it reimbursement access or is there anything else. The physicians are looking for non I have a follow up thanks.

Thank you Jason.

Scribe and I'll, let Lauren and address some of those just a.

Bit of and intro of of course, it's early goings as you know and we also have a number of we're looking at kind of triangulating and number of different areas of demand. So we see the the audited data, but we also have activity within our hub services and then we're starting to take requests.

And for samples for from physicians that have yet to be distributed to the patients with the prescription or have a prescription involved so let me, let laura and provide a little more color on that.

Yes. Thank you for the question Jason.

Yes.

And it's a little bit.

Convoluted.

And because of how early it is sales.

Of course, we.

The prescription data that you see as well.

But the the.

Factors include the 100 patients we've seen come through the our hub services as well as over 150 requests for samples for starters. So we had seen.

Quite a bit of interest from prescribers to start patients.

Even in these early weeks, although it may not all of the in the data yet because of because they are receiving.

Simple first.

And then as far as the anecdotal feedback from the field.

We have been very pleasantly.

Right.

With the positive feedback from prescribers, it's clear that they understand there is an unmet need here with.

And with the treatment options that were previously available and they understand the the value that <unk> brings from a clinical perspective.

As far as what.

<unk>.

<unk> caused some hesitation I think.

They are very sensitive to payer coverage and so we are actively in discussions with payers and hope to have some decisions relatively quickly that will help us to build confidence in.

And the payer landscape and payer support for my summary.

And at least the meantime, we do have our patient support services and we've received positive feedback from our physicians are not.

And not just the services themselves, but also the hub and the level of support that they receive and going through the hub. So we believe we're doing everything we can at this point and are confident that we will continue to build.

And the confidence as they get experience with the drug.

And also as we build that payer coverage.

Great and then Dave just as a follow up can you talk.

And any more color about the extension of the Pfizer often.

Is this being driven by waiting for more commercial information.

Sharon or regulatory dynamics or any additional color you can give us there.

Sure look we enjoy an excellent relationship with Pfizer.

And have been in discussions regarding the opportunity in Europe, and really we just felt that.

As we were going through some.

Discussions debt and extension was warranted just to allow.

Pfizer to complete its diligence and make a fully informed decision so.

And we feel very comfortable with the.

The discussions that we're having and we wanted to ensure that they had the right.

The duration.

<unk> of time to fully explore the opportunity so.

And we support that.

Great.

Thanks for taking the questions and congrats again on the the launches.

Okay.

Okay.

Our next question comes from Eric Joseph with JP Morgan.

Some of these do your line is open.

Hey, good morning, Thanks for taking the questions.

And thanks for all of the color on the on the global launch.

<unk> metrics the.

And the 75% versus 25% net breakdown of the ships and selling from specialty distributors versus pharma.

On the pharmacies can you talk.

What about how that compares with the historical demand trend with ADT and Eric walkers the skew some.

And just wanted to get a sense of where you kind of see.

Kind of the greater.

Level of headroom and either of those segments and then perhaps just a follow up also.

On the extended adopted the Pfizer or is there something particularly about this timeframe to October.

So as opposed to the end of the year.

And you would rule out and additional extension of the of the Atkins.

And 1 thanks.

Well, thank you Eric.

I'll, let Laura and address the.

The question regarding the breakdown of of kind of source of demand and then ill take the Pfizer question Lauren.

Yes, thanks for the question.

And I can't speak to the comparison to other <unk>.

Market places, but what I can say is that this is playing out exactly as we expected we knew from the beginning.

Beginning that.

It was important for us to to remove any disincentive.

And for using <unk> from a from a financial perspective to support offices from and operational perspective and of course to build the confidence and our clinical profile.

And.

The first fully expected that the majority of our business would be flowing through the specialty distributor channel and we expect that for the foreseeable future that debt that is our plan.

And that's why we're continuing to bring on new accounts.

From a from a from the perspective of using our <unk> many of which are dispensing.

So.

And so we would expect this is exactly as we expected and we think the mix will stay.

And similar to what it is today.

And then regarding the Pfizer opt in decision Eric There really was no market or regulatory milestone that led to the specific.

Thank the day of roughly 90 day extension. It was really the amount of time that we felt like was warranted to allow them to complete their diligence. So that was really the nature of it we just sat down and thought.

That that timeframe would make sense and it doesn't necessarily mean that.

And that they will take the full 90 days to get to a decision we.

And we just felt like that was enough lead time to allow for the proper diligence to be done and for them to have conviction and their decision.

Okay, great. Thanks, both us and the customer.

Yes.

Sure. Thank you Eric.

Our next question.

Come.

Comes from Phil Nadeau with Cowen and company. Your line is open.

Let me add my congratulations on the the 2 simultaneous launches.

First a question on on our Globex I appreciate that's early days.

A sense of how patients are using <unk> is it being.

The news is chronic therapy or the.

And adopting and using them and an instrument and fashion and.

Any sense of of.

And what role is playing and the treatment.

Yes, Phil I don't think we of the proportionality, but I think overall, we believe it's more chronic therapy. We know there is some intermittent use debt that we hear anecdotally.

We don't have the data specific to that but the vast majority of the feedback that we're getting is for chronic use and I think as Lauren mentioned, a disproportionate share of those are new to ADT therapy.

Perfect and then second question.

Digger amongst the supposed to have cardiovascular safety data come out of I think.

And of course.

We've heard from physicians that that could really spur of the market towards the antagonist should it should.

So the benefit to figure out ex <unk>.

Are you of any sense of when that day, there could be released it seems like according to Clinicaltrials Gov, the patrol and completed some time ago.

Yes.

I don't have particular insight in terms of the.

The timing for their data and what I would say is that we certainly received very positive feedback around the data that we were able to generate through our hero trial as it relates to cardiovascular risk and.

And we're very heartened to hear the feedback from clinicians as cardiovascular risk has really continued to become.

Any day duration increasingly.

Increasingly with the proper awareness of the cardiovascular risk that these patients have so we're happy to see the increased attention on that we think that's good for.

The providers and we think it's good for patients.

Great and then last question.

And Laurence prepared remarks, you mentioned the unmet need for.

The consumer treatment of uterine fibroids I'm curious if as you from because you've been detailing the practices of a better understanding of what is the abbvie has kind of done wrong way or hence launch hasn't gone better and therefore what book.

What ways could you improve with my February to give us uptake to be.

Some of it more.

The rapid than what we've seen from the competitor.

Yes, I think it starts with really deep understanding of the marketplace and I'll, let Laura and address Theres kind of 3 key areas that we focus on.

Leading up to the launch and we think each of those provide a significant departure from from what's.

What's occurred previously so Lauren.

Thanks, Dave.

As you have we have observed the.

Competitive launches and the accounting challenges that they face and learn from that and I think the first thing. That's most important is that our clinical profile is really unique and uniquely meeting.

And the specific needs that prescribers.

Say that they have and this market as well as patients and so we're bringing a unique offering to the this market. The second thing is that we are optimizing the first experience for patients.

Invested a great deal and making that first experience of positive 1.

And that's something that we learned.

What's the challenge and previous launches and then finally, we believe our field execution with having 2 teams both of which have a lot of women's health experience.

And being able to flex those teams appropriately to reach the the the breadth of targets.

1 market since it is very diffuse, but also being able to get the frequency where it's needed.

And the Windows.

Believe that we'll be able to show up differently then.

And competitors have and the path.

Perfect. Thanks for taking my questions.

Okay.

Thank you.

And this may and our next question is from Brian <unk> with Baird. Your line is open.

Hey, good morning, guys. Thanks for taking my question and congrats on the.

The first of all of them launch so far.

Yes.

Switch topics a little bit I was just wondering if you could kind of give us some details on the on the protocol Amendment and BMD.

During it and the Serene study and just kind of how to think about that.

Going forward and and just in terms of the role of <unk> and.

The pregnancy prevention and how do we kind of think about the safety profile of the efforts of approved oral contraceptives I got sort of the substantial efficacy benefit over these and U F on endometriosis, but can you help understand what you.

You see as the potential differentiation and pregnancy prevention on here. Thanks.

Certainly all of it.

And 1 camilo address that at the risk of things that we don't typically comment on the FDA discussions back and forth, but the 1 camilo what can you share with us.

I think that debt.

With regards to the amendment, we follow the.

The monitor and we received from FDA and we've submitted the.

The amended protocol to them, we expect to hear back from and then soon.

And expect that to be with.

And hopefully a removal of the hold and allowing us to restart the study with regards to the second part of good question about the.

And I think that.

And as you know women with uterine fibroids and in the future of women with endometriosis are premenopausal women and.

They are considering their options for treatment for their there and the thesis that debt.

And we're talking about the are also considering they are productive.

The petition.

And that included the includes contraception and so the ability to have.

Debt treat the theyre.

There are symptoms of uterine fibroids endometriosis.

And provide prevention of pregnancy is something that we've heard loud and clear from from gynecology and for from women to.

B.

Pretty important differentiating factor and something that they really care about.

I can tell you that the gynecologists that that's something got on.

Top of mind since we started developing <unk> combination tablet.

And I.

And I can't imagine and those conversations happening in the clinic. So we feel very strongly that this is a.

Pretty important component to the future of <unk>.

And and the treatment of uterine fibroids and into maturity.

Great. Thanks.

Thank you.

Thank you. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.

And Paul Your line is open.

And we cannot hear you Paul.

And please press star 1 to get back in the queue and we went and proceed with the next question from Josh <unk> with Evercore ISI.

Hi, This is gavin on for Josh on nice quarter and thanks for taking the question just had 1.

On the provider economics for our Covid, that's the strength through the provider owned specialty pharmacies.

I believe you had mentioned that the practice economics were pretty similar to the gnrh.

Agonist the.

The given how our road and their ASP is and where it will go the black is priced it feels like there would be room to offer a little better economics could you just elaborate on this dynamic of it.

Yes, certainly what we have seen the the change and Asps, Laura and maybe you can address that.

Yes.

Yes and.

And so.

As I believe Youre already aware, we have contracted with.

With the clinical accounts.

And but when we did that we did that to remove any disincentive from a from an economics perspective.

Since then the.

The ASP.

Dynamic for our competitors has has changed we are not affected by that.

And and.

At this point it actually improves the economic dynamic.

In favor of <unk>. So we currently do not have any plans to change.

Our contracting strategy.

<unk>.

But the way that clinics.

Chairman.

How this plays out and their clinic and their decision, making is up to them and.

And and.

And it's unclear.

Uh huh.

How much of a role that will play considering that shifting of patient.

Especially for some Medicare.

It may.

It may change their co pay and so offices will have to consider both dynamics and making their treatment selection.

Did that answer your question.

Yes, that's helpful. Thanks.

Thank you.

And.

And again, if you have a question simply press star 1 on your telephone and we have a question from the line of Paul Choi with Goldman Sachs. Please proceed.

Hi, Thank you sorry about earlier.

2 quick ones from from our side. Please just.

With regard to your other.

<unk> on for demand for <unk> share of can you, maybe just sort of comment on how youre thinking about potential changes.

With regard to patient visit levels, just given what seems to be the changing backdrop with regard to to COVID-19.

And any additional color you can say there.

And then I had a follow up question on <unk>.

Yes, I'll, let Laura and address that I think we're seeing certainly per.

<unk> <unk>.

Dynamics I think are different and the urologist office versus the oncology office of Lorne do you want to address that yes. Thanks Paul.

Comments.

So I think theres 2 elements of out of it and the fact right.

The there's 2 elements of the Covid impact 1 is what you were referencing which is patients going into the clinic.

And we've essentially seen that return on most of our pre COVID-19 levels.

And.

And where we're comfortable that that dynamic is rebounding now the second part is the access that we have to customers and to Dave's point that does vary between urologists and oncologists with oncologists managing immuno suppressed patients they are a little more restricted at.

So however in both cases urologists and oncologists that access has improved and so that's why we're able now to have a higher percentage of in person details which is more valuable.

And allows us to have greater access to our customers.

Which is important to driving.

This plan.

Okay. Thanks for that.

Additional color Lauren and then on my Fabri I appreciate that the debt. The early sales were primarily stocking and inventory.

I guess with regard to messaging and in the market and.

Having a sort of more fulsome presence.

And the market this quarter for.

And for either Dave or Laurens here I guess.

Can you, maybe just sort of reframe for us okay.

And the learnings from the.

And the competitors launch and just where you will primarily be focusing on addressing questions where.

And there may have been resistance among potential prescribers for the for the.

5 income H class here and just what what additional messaging Youll book.

Range of market. Thank you very much.

Well, Thanks, Paul I think 1 and 1 thing just for context, the real opportunity is not really for us too.

The focus specifically on the.

Gnrh antagonist.

On the class I think the real opportunity.

Is to really look at those women, who are still on oral contraceptives who've been failed by the first line therapy, we're looking at.

And 3 million women, who have been failed by their first line therapy and another <unk> <unk>.

Total of 5 million.

Who are seeking treatment.

If we can step in and provide on a better option for those patients with our clinical profile and then.

And specifically with the.

And with our administration of 1 tablet once a day, we think thats really where the opportunity.

And women to use and that is really where we think we can unlock the full potential of this marketplace I think our clinical profile.

And with our 1 pill once a day it makes us.

Really the ideal choice that physicians are telling us theyre looking for and we think now coupled with the positive.

For 200 and that we're having with payers, we think that the payer environment will open for us.

As we hope and and the interim we certainly have all of the patient support services to support the offices and the patients along the way. So we feel very good about the ability for my family to make a significant impact on the marketplace and really provide.

The treatment that both clinicians and patients have been waiting for.

Thank you very much.

Thank you.

And I'm not sure and any further questions in the queue I will turn it back to day for his final comments.

Okay. Thank you well look <unk> is at a very exciting time with 2 launches underway with differentiated therapies that can really make a meaningful difference for patients with advanced prostate cancer and with uterine fibroids.

We are very well positioned both operationally and financially to deliver strong.

Strong commercial execution as well as build sustainable long term value. So thank you all and I look forward to keeping you updated on our progress.

And ladies and gentlemen, this concludes <unk> Sciences first fiscal quarter 2021 earnings conference call. Thank you for your participation.

And and you may now disconnect.

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And so patients.

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Yes.

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And.

Thanks.

And.

Okay.

Revenue.

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Yeah.

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Yeah.

[music].

Good day, everyone and welcome to my event Sciences first quarter of fiscal.

And here 2021earnings conference call today's call is being recorded at this time I would like to turn the call over to Ryan <unk>, Vice President of Investor Relations at Mail, but please go ahead.

Thank you operator, good morning, and thanks for joining us today to review the financial results of my events first quarter of fiscal year, 2020, 1 and to discuss other corporate and business updates.

Joining me for today's call are Dave Marek <unk>, Chief Executive Officer, Frank Carbo, President and Chief Financial Officer, Laura and Marin D&O Chief Commercial officer.

And Dr. Juan Camilo Arcana, Chief Medical Officer.

In addition to the press release issued earlier today the slides that will be presented during today's webcast are available on our investor Relations website investors thought and <unk> dot com.

Today, we will we will be referring to our fiscal first quarter, which ended on June 30 of 2021.

First quarter or Q1 throughout this presentation.

During the course of this conference call, we will be making forward looking statements. These include plans and expectations with respect to our products product candidates strategies and opportunities and financials, all of which involve certain assumptions of the risks and uncertainties that are beyond our control.

And sorry, and could cause actual results to differ materially from these statements and the.

Discussion of these risks can be found in our SEC disclosure documents and addition, might've asked does not undertake any obligation to update any forward looking statements made during this call.

I'll now turn the call over to Dave Mary <unk>, Chief Executive Officer.

Dave.

Thank you Ryan and good morning, everyone.

<unk> 2021 fiscal year is off to a strong start marked by accelerating commercial momentum and the U S and significant regulatory achievements that will enable us to bring our differentiated therapies to more and more patients.

Control and our first quarter mild and recorded $41.1 million.

Of total revenue, including $11.6 million of product revenue and $29.5 million of Pfizer collaboration revenue.

During the second quarter on the market for <unk> achieved revenues of $10.5.

Lynn.

Reflecting strong sequential growth quarter to quarter.

This continued growth reflects increasing enthusiasm from clinicians regarding the differentiated clinical profile of <unk> as well as increased payer coverage.

We're also pleased with the FDA.

And 5 level and June launch of my memory as.

And as the first and only once daily oral treatment for women with uterine fibroids.

We achieved revenues of $1.1 million, reflecting initial inventory stocking by distributors.

We and Pfizer conducted of simultaneous launch.

Lunch and remain excited to bring this differentiated profile for the millions of women battling uterine fibroids, where high unmet need remains.

From a regulatory standpoint, we've achieved several significant milestones over the past few months.

In addition to the FDA approval of <unk>.

And I approve of the European Commission also approved <unk> the.

The European brand name for <unk> combination tablet.

The commercial launch of <unk> is expected to begin in the second half of this calendar year and will be executed a guinea and Richter <unk> commercialization partner for <unk> and Europe.

The approval of <unk> is notable for a couple of reasons.

Not only as of the first once daily oral treatment for women with uterine fibroids approved in Europe.

It's also the first treatment that does not have a limitation on duration of use.

Recall that our European regulatory submission included 2 year of bone mineral.

<unk> density data from the phase III Liberty randomized withdrawal study.

And those data were not available at the time of our FDA submission.

We do intend to submit the 2 year of BMD data to the FDA later this year for potential inclusion and the my memory label.

Also from my memory.

And in early July we submitted a supplemental NDA and the U S seeking approval for the management of moderate to severe pain associated with endometriosis.

And finally and response to the FDA partial clinical hold regarding the phase III Serene study for my summary to evaluate the prevention of pregnancy.

In July we provided the FDA with and amended study protocol.

Where we are incorporating the MD monitoring as well as modifying the study population per their guidance.

To better support the prevention of pregnancy claim and women for whom Mike on Breeze indicated.

Following further discussions.

<unk> with FDA, we expect the partial clinical hold to be lifted next month.

Turning to business development and intellectual property update Myles.

<unk> and Pfizer recently agreed to extend the timeline for Pfizer's decision regarding its option to acquire a development and commercialization rights to.

The bullets and oncology and Europe and other international markets.

Through the end of October.

In June we also took another step and protecting our intellectual property as we were issued a new methods of treatment patents.

Which could expand the exclusivity period for my February and uterine fibroids.

This patent and joins to other methods of patents previously granted for <unk> for treating advanced prostate cancer, all of which are now listed and the FDA Orange book with exploration and September of 2037.

And finally, we continue to be on and excellent financial position.

And with cash and committed financing of over $600 million as of June 30 <unk>.

Excluding of $115 million of recently triggered regulatory milestone payments from Pfizer and Richter.

We're excited about the opportunity that we have with my family to redefine care for women with.

Uterine fibroids and we continue to be encouraged by the continued launch momentum for <unk>.

Now for a more in depth review of our commercial performance I will turn the call over to Laura.

Lauren.

Thanks, Dave.

Today I'll provide an update on the early progress.

We have made and the launch of my summary, followed by an update on the all of the other clients.

And my Thunder was approved by the FDA and late May and as the first and only once daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids and pre menopausal women.

We believe my family has the potential to be of truly meaningful advance and women's health and could become the standard of care medical treatment for women with uterine fibroids.

The unmet need in uterine fibroids is enormous.

Approximately 5 million women and the U S have sought treatment for symptoms.

The uterine fibroid.

On the women, 60% our sales by first line therapy, typically oral contraceptives, which are unable to control the most challenging and Kevin.

Even the 2 out of 3 women prefer and medical option versus surgery.

Ultimately 250000.

And women per year, and the U S make the difficult choice to undergo a hysterectomy for relief from their uterine fibroids.

Mylan and Pfizer are United and our goal to provide these women with and effective well tolerated and convenient medical option.

We believe my family aligns well with physicians.

And David treatment goal of meaningfully improving heavy menstrual bleeding and other challenging symptoms with minimal side effects and and easy and convenient dosing regimen.

My family has the potential to redefine care for women with uterine fibroids, because it makes the treatment needs for this market.

And the Liberty clinical trial program, My summary, and demonstrated sustained and meaningful reduction and menstrual blood loss.

Hot Flash, and particularly bothersome and side effects occurred and less than 11% of my summary of patient not meaningfully different than the approximately 7% of patients.

And is treated with placebo.

And the Liberty clinical program, the average decline and lumbar spine bone mineral density at 12 months was under 1%.

However, due to the risk of continued bone loss and the duration of use and the FDA label is limited to 24 months.

Finally.

And finally my family achieved all of this and 1 small pill taken just once a day.

The Mylan and Pfizer of commercial teams have worked collaboratively to meet the operational milestones required to position <unk> for a differentiated launch.

Before launch we initiated engagement with key payers.

For timely access.

And we've accomplished a lot within the first few weeks following approval, including activation of the member websites.

Fully stocking of the distribution channel.

Activating patient support services.

And beginning in person field force engagement.

More.

More recently in July we began offering starter packs to certain prescribers, who have identified patients to initiate on my fabri therapy.

All of these steps were taken with the intent of ensuring a positive first experience for providers patients and payers and the hallmark of our launch strategy.

Just to remind that and Pfizer sales teams have already conducted more than 20000 and sales calls and the first 5 weeks since our launch.

With nearly 90% of these interactions being and person, reaching over 60% of our high and medium priority target prescribers.

This activity has improved 8.

Aided awareness among potential prescribers from approximately 30% prelaunch to nearly 50% as of July.

This early in launch patient experience and just beginning and we are encouraged by the approximately 100 patients that have enrolled and my assembly patient support services.

Additionally.

Finally over 150 patients have been identified by prescribers as candidates for starter packs and just the first 2 weeks since launching the startup program.

Obtaining payer coverage for my family is among our top launch priority.

We anticipate that approximately 85% of patients.

That could be prescribed my fabri are commercially insured the.

The remaining 15% of potential patients primarily include Medicaid or cash patients.

As of July 1st 37% of commercial lives were eligible for pre review coverage for my summary.

And we believe my family is well positioned to establish access that supports prescriber choice and minimize out of pocket cost per patient.

The certain payers, we have already made significant progress and believe some initial coverage decisions could be implemented as early as of August.

We.

We believe my summary of addresses the needs of providers and patients with its clinical profile and convenient 1 pill once a day dosing.

We are excited about the progress that we've been able to make and the early days of launch and will be bringing a new and differentiated treatment option for women with uterine fibroids.

I'd now like to discuss the continued progress we've made on the <unk> launch.

Although the launch momentum continues to build as we and Pfizer and work toward redefining care for men with advanced prostate cancer.

6 months following our launch we estimate that over 4500 men have.

Treated with all of <unk>, reflecting steadily increasing adoption.

We recorded $10.5 million of our <unk> net product revenues in fiscal Q1, reflecting substantial demand driven growth compared to fiscal Q4.2020.

Monthly.

And have been treated cumulative patients on therapy, which includes both patients on free and commercial drugs have increased every month since launch, culminating in June where we estimate that over 4500 men have been treated with oral <unk>.

And May and June and we estimate that approximately 1000 patients initiated on.

Estimate therapy, and each month, reflecting a consistent and gradual trajectory that we've seen since launch.

It's important to note that since launch of approximately 1 third of patients treated with I'll go back and receive free drug utilizing either our free trial bridge or patient assistance program.

Although.

Although visibility into patient level data and complete we.

We estimate that approximately 60% of patients that started on globex, where previously naive the androgen deprivation therapy.

Additionally, we believe that although this is being utilized treat patients across the spectrum of advanced prostate cancer, reflecting on.

1 of them visit FDA label.

And the therapeutic appeal of the on <unk> clinical profile, regardless of patient types.

And we have discussed before there of clinical economic and operational considerations that can play a role and ADT treatment decision.

Since launch.

<unk> been actively engaging with prescribers to drive on building awareness and build recognition of its differentiated clinical profile.

And the first 6 months of launch my event and Pfizer have conducted over 42000 and sales calls.

With over 13000 providers and.

Including reaching nearly 90.

90% of our highest priority target prescribers.

As the launch has progressed and COVID-19 restrictions on in person detailing has eased the volume and quality of our engagements with health care providers and other practice personnel has increased significantly.

In June.

And when the 5% of Mylan, and Pfizer sales engagements, where and person which is up from 38% in February.

We remain optimistic that we can maintain or increase this level of imports and detailing and the second half of 2021.

Net sales efforts are delivering results.

Although the share of voice continues to dominate the Gnrh class and was nearly 50% and Jim.

Our recent market research indicate near Universal aided awareness amongst target prescribers with 82%, indicating that they are knowledgeable about the oracle <unk> clinical profile.

We have also successfully broadened the base of prescribers to approximately 1150 treatment centers through June and increase of approximately 300 of 50 and just the last 2 months.

The reorder rate also remains high with 80% of practices reordering or at least 1 up.

Only 5% at the end of April.

Finally, our market access team has worked diligently to enable E prescribing and as of early July. Although this was available across all of the EMR systems utilized and practices that we are actively targeting up from approximately 60% at the.

From Stifel.

Utilizing data from our patient support hub and specialty pharmacy network, we estimate that approximately 56% of <unk> prescriptions have been written by urologists and 40% by oncologists.

This early trend is in line with the 2020 patient claims data.

Data for the ADT class.

And as expected the vast majority 75% of the although the commercial volume has been shipped via the specialty distributor channel, which serves practices and institutions with dispensing capabilities, such as large urology group practices hospitals academic.

And of errors and integrated delivery networks.

The specialty pharmacy channel, which serves patients of practices that do not have and office pharmacy capabilities.

Distributed the other 25% over of the <unk> commercial volume and is expected to remain the smaller channel for our buildings going forward.

We have also made notable progress.

Centers and building commercial and part D coverage for <unk>.

As of July 1.

We have coverage for over $150 million total lives and increase of 49 million lives since may 1st.

Let's take a look at the progress we've made since may.

On the commercial side, although the ex coverage expanded.

Progress 20 percentage points to 63%, adding $36 million incremental covered lives since may 1st.

Plans that cover 28% of commercialized have yet to make of 2021coverage decision, but are expected to do so in the coming months.

We have made even greater.

And our progress with Medicare part D.

Where we achieved coverage for both of its for 78% of lives as of July 1 and.

And increase of 27 percentage points for 13 million lives since the beginning of May.

Plans that cover the remaining 22 per cent of part D lives may implement coverage decision.

Handed by this year with some of these plans potentially deferring, although the coverage implementation to early next year.

Importantly, all payers contracted to date have agreed to cover <unk>. According to our FDA approved prescribing information.

In closing, we can pan and make tremendous progress.

And later all areas of our <unk> launch and have built great momentum and the prostate cancer community.

As we look forward with in person engagement, increasing the impact of clinician engagement.

And improved commercial and part D coverage for patients, we believe that prescribing momentum will continue to steadily build and.

Across the us will make a difference and the lives of many more men battling advanced prostate cancer.

I will now turn the call over to Frank to review our financial results.

Thank you Lauren.

And as usual I will focus my comments on the highlights of our financial performance in the quarter and refer you.

Our press release and form 10-Q issued earlier today for additional information.

Let's begin with revenue.

My of it recorded $41.1 million of total revenue for the first fiscal quarter ending June 30 of 2021.

Composed of $10.5 million.

And $1.1 million of net product revenue from <unk>, and my favorite respectively, as well as $29.5 million of Pfizer collaboration revenue consisting of $21 million related to the partial recognition of the upfront payment received.

And we see from Pfizer and December 2020.

And $8.5 million related to the partial recognition of a 100 million and regulatory milestone payment was triggered upon FDA approval of my family.

In future quarters.

The Pfizer upfront payment will continue to be amortized at the rate of $21 million per quarter.

And the Max temporary uterine fibroid FDA approval milestone will be amortized at $4 million per quarter through the end of calendar year 2026, when the amortization period is scheduled to end.

For fiscal Q2.2021, we also expect to recognize.

Approximately $31.7 million of license and milestone revenue from our collaborations.

And with Gedeon Richter.

On price of the 15 million of regulatory milestone for the July 2021 European Commission approval of <unk> for uterine fibroids.

And $16.7 million related to the remaining.

Remaining portion of the upfront and the initial milestone payments.

Moving on to other highlights of our income statement.

Cost of product revenue for the quarter was $1 million and largely comprised of the high single digit royalty on net sales of for Covid payable to Takeda.

And to a lesser.

Expenses related to the cost of goods sold for Covid and my family.

Collaboration expense was $5.3 million, reflecting pfizer's, 50% share of net profit from the sales of for <unk> and my family in the U S. During Q1.

R&D expenses in.

The first quarter with $30.9 million.

Compared to $44.2 million for the comparable prior year period.

The decrease and R&D expenses was mainly driven by cost share reimbursements from Pfizer.

As well as a reduction in clinical study costs, resulting from the completion and wind down of my of.

For extended 3 Liberty hero and Spirit studies.

The decrease also reflects lower regulatory expenses in Q1.2021 as the prior year period included Nda's submission fees for our Globex and my family.

These decreases were partially offset.

Primarily by higher expenses incurred by May of into the medical Affairs organization, which was built out and recent quarters to support the aerobics and my family and launches.

As well as increased study costs related to really the lifecycle management activities.

SG&A expenses and the quarter was $61.2 million.

And stay compared to $22.8 million for the comparable prior year period.

The increase was primarily due to higher expenses related to commercial activities to support the U S launches of <unk> and my family.

And higher personnel related costs in connection with the hiring of my of its commercial operations marketing.

And market access teams as well as the oncology and women's health sales forces.

My haven't generated a net loss of $61.7 million of <unk> 67 per share and the first quarter of 2021 compared to a net loss of $32.9 million or <unk> 37 per share.

<unk> prior year quarter.

Looking ahead R&D expenses for the remaining fiscal 2021 quarters are projected to be modestly lower than Q1 actual spend.

SG&A expenses for the remaining fiscal 2021 quarters.

And the expected to increase modestly from Q1 actual spend.

We ended the fiscal Q1 with total cash and committed financing of $611.1 million.

Comprised of $569.8 million of cash cash equivalents in marketable securities.

And $41.3 million of capacity remaining under the low cost non facility extended to us by Sumitomo Dainippon pharma on a majority shareholder.

This balance does not include $115 million of recently triggered milestone payments from the regulatory approvals of <unk> and <unk>.

I received the $100 million milestone payment from Pfizer and July 2021, and expect to receive the $15 million milestone payment from Victor and second fiscal quarter of 2021.

Yeah.

Our cash position and potential future milestone payments over the next 12 months.

Coupled with the sharing.

From the expense with Pfizer and the anticipated increase and <unk> and my family of revenue puts my event and an excellent position to execute our commercial strategies while.

While at the same time expanding on our pipeline through future rarely go ex lifecycle of programs and business development.

I would like to wrap up with a bit more color on the recent developments pertaining to our intellectual property associated with really goal, which we believe could extend U S marketing exclusivity for both <unk> and my family into late 2037.

Significantly expanding the value of the railway goes ex franchise.

And of sort of pick the tier is a subset of the patents listed on the FDA Orange book for.

Each product.

Each product has 3 listed patents relating to the composition of matter of case, which we have highlighted previously.

The Gray bar on the first compensation case indicates that we have to apply for patent term extension.

Currently pending a decision from the FDA and USB T O.

We expect to receive the full 5 year term extending of the rally the species patent to January 2029.

The more recent development pertained to method of treatment patents, which represent the culmination.

Which of use of research and innovation.

All 3 of these patents expire in September of 2037, potentially extending the U S marketing exclusivity for these products.

The 2 methods of cases for our globex cover among other aspects of the particular dosing regimen for <unk>.

And of the methods of patent for my family was issued last month and covers and the use of our unique <unk> combination tablet to treat the FDA approved us relating to urine fibroids.

Among others. We have also filed the patent application, which is current depending on our next anticipated indication for my family relating to.

And that of endometriosis.

Now with that I'll turn it over to Dave for some closing remarks, Dave.

Thank you Frank and Lauren.

The approval and launch of <unk> represents a significant milestone and expanding the treatment options for women with uterine fibroids to include.

<unk> for the first time of 1 pill once a day regimen with the clinical profile of that prescribers and patients have long desired.

We're encouraged by the early progress that we've made with <unk> launch and look forward to delivering this important new medicine to patients.

For the <unk> also excited about the launch momentum that we've been able to generate for <unk> through our strengthen prescriber educational efforts and increased payer coverage that we achieved over the past few months.

In addition to continuing to execute on the oil growth ex and <unk> launches and the remainder of 2020.

We're all bring several other important milestones.

By the end of October we expect Pfizer's decision regarding the international option for <unk> rights and oncology.

And the second half of the calendar year, we expect Gideon and Richard to launch <unk>, and Europe and to submit the European filing.

And for endometriosis.

We also expect to submit our randomized withdrawal study results to the FDA by the end of the calendar year, which will include 2 year bone mineral density data.

And looking further ahead into the calendar year of 2022.

We expect a European Commission decision.

And on our advanced prostate cancer filings.

As Frank highlighted we continue to operate from a position of financial strength.

Which gives us the flexibility to sufficiently fund our U S product launches, while simultaneously expanding our pipeline through value Golar lifecycle opportunities.

And business development opportunities.

I am extremely proud of the passion and the work done by our mild and team to enable us to deliver on our mission to positively impact the lives of so many men and women.

Thank you for your attention and I'll turn the call over to Ryan to begin the Q&A session.

And thank you Dave operator can we now please poll for questions.

Secondly, and as a reminder to ask the question Press Star 1 on your telephone keypad.

To withdraw your question press, the pound or hash key.

We have a question from the line of Jason Butler with JMP Securities. Your line is open.

Thanks for taking the questions and congrats on the progress.

For the first 1 for me just in terms of the my farm for a launch.

Can you just give us the sense I know, it's earlier of what number of prescribers of your target prescribers.

Scrubbers are actually already writing prescriptions.

And whats the feedback youre getting from from the initial interactions in terms of what docs would need to start writing prescriptions is it reimbursement access or is there anything else. The physicians are looking for and then I have a follow up thanks.

Thank you Jason.

I'll, let Lauren and address some of those just as of.

A bit of and intro of of course, it's early goings as you know and we also have a number of we're looking at kind of triangulating and number of different areas of demand. So we see the the audited data, but we also have activity within our hub services and then we're starting to take requests.

For samples for from physicians that have yet to be distributed to the patients with the prescription.

A prescription involves so let me, let and lower and provide a little more color on that.

Thank you for the question Jason.

Yes. This is Dave.

And it's a little bit.

<unk>.

Because of how early it is sales.

Of course, we have prescription data that you see as well.

The other factors include the 100 patients we've seen come through the our hub services as well as over 150 requests for samples for starters. So we have seen quite.

Right now of the interest from prescribers to start patient.

Even in these early weeks, although it may not all of the in the data yet because of because they are receiving.

Samples first.

And then as far as the anecdotal feedback from the field.

We have been very pleasantly.

Quite a bit is with the positive feedback from prescribers, it's clear that they understand there is an unmet need here.

With the treatment options that were previously available and they understand the the value that <unk> brings from a clinical perspective.

And as far as what.

<unk>.

And caused some hesitation I think that debt.

And are very sensitive to payer coverage and so we are actively in discussions with payers and hope to have some decisions relatively quickly that will help us to build confidence in.

And the payer landscape and payer support for my summary.

And so clean time, we do have our patient support services and we've received positive feedback from our physicians on.

Not just the services themselves, but also the hub and the level of support that they receive and going through the hub. So we believe we are doing everything we can at this point and are confident that we will continue to build.

The confidence as they get experience with the drug.

And also as we build that payer coverage.

Great and then Dave just as a follow up can you talk.

And any more color about the extension of the Pfizer often.

Is this being driven by waiting for more commercial information.

Sharon or regulatory dynamics or any additional color you can give us there.

Sure look we enjoy an excellent relationship with Pfizer.

Have been in discussions regarding the opportunity in Europe, and really we just felt that.

As we were going through some.

Discussions that and extension was warranted just to allow.

Pfizer to complete its diligence and make a fully informed decision so.

And we feel very comfortable with the.

The discussions that we're having and we wanted to ensure that they had the right.

Some of these time to fully explore the opportunity so.

And we support them.

Great.

Thanks for taking the questions and congrats again on the for launches.

Right.

Okay.

Thank you. Our next question comes from Eric Joseph with JP Morgan.

Again, the your line is open.

Hi, good morning, Thanks for taking the questions.

And thanks for all of the color on the on the global launch.

<unk> metrics the.

The 75% versus the 25% of breakdown of the ships and selling from specialty distributors versus pharma.

On the pharmacies and you talk.

Talk a little bit of that how that compares with the historical demand trend with EDC and Eric walkers the SKU.

And I'm, just trying to get a sense of where you kind of see.

Kind of the greater.

Level of headroom and either of those segments and then perhaps just a follow up also.

On the extended adopted the Pfizer or is there something particularly about this timeframe to October.

So as opposed to the end of the year.

<unk> grew out of an additional extension of the of the Atkins.

Deadline. Thanks.

Well, thank you Eric.

I'll, let Laura and address the.

The first question regarding the breakdown of of kind of source of demand and then ill take the Pfizer question Lauren.

Yes, thanks for the question.

And I can't speak to the comparison to other <unk>.

Marketplaces, but what I can say is that this is playing out exactly as we expected we knew from the beginning.

And bad.

It was important for us to to remove any disincentive.

And for using or go back some of from a financial perspective to support offices from and operational perspective and of course to build the confidence and our clinical profile.

And.

Begin a fully expected that the majority of our business will be flowing through the specialty distributor channel and we expect that for the foreseeable future debt that is our plan.

And that's why we're continuing to bring on new accounts.

From a from a from the perspective of using our <unk> for many of which are dispensing.

So we.

And so we would expect this is exactly as we expected and we think the mix will stay.

And similar to what it is today.

And then regarding the.

And the Pfizer opt in decision Eric There really was no market or regulatory milestone that led to the specific.

And 90 day of roughly 90 day extension. It was really the amount of time that we felt like was warranted to allow them to complete their diligence. So that was really the nature of it we just sat down and thought.

That the timeframe would make sense and it doesn't necessarily mean the.

And that they will take the full 90 days to get to a decision we.

We just felt like that was enough lead time to allow for the proper diligence to be done and for them to have conviction and their decision.

Okay, great. Thanks, both us and the questions.

Sure. Thank you Eric.

Our next question.

Come.

And felt and adult with Cowen and company. Your line is open.

Good morning, let me add my congratulations on the the 2 simultaneous launches.

First of all of a question on on our Globex I appreciate that's early days.

For a sense of how patients are using <unk> is it being.

Being used as chronic therapy or the <unk>.

And then adopting and using an and and instrument and fashion and.

Any sense of of.

The rule is playing in and the treatment.

Yes, Phil I don't think we of the proportionality, but I think the overall, we believe it's more chronic therapy. We know there is some intermittent use debt that we hear anecdotally.

And of course, we don't have the data specific to that but.

The vast majority of the feedback that we're getting is for chronic use and I think as Lauren mentioned, a disproportionate share of those are new to ADT therapy.

Perfect and then second question.

Digger losses is supposed to have cardiovascular safety data come out of I think.

Any day, we heard from physicians that that could really spur of the market towards the antagonist should it should.

Sure of benefit to figure out do you have any sense of when that data could be released it seems like the kind of clinical trials tech of the trial completed some time ago.

Yeah.

I don't have particular insight in terms of the.

Timing for their data of what I would say is that we certainly received very positive feedback around the data that we were able to generate through our hero trial as it relates to cardiovascular risk and and we're very heartened to hear the feedback from clinicians as cardiovascular risk has really continued to become.

The duration increasingly with the proper awareness of the cardiovascular risk that these patients have so we're happy to see the increased attention on that we think that's good for <unk>.

Providers and we think it's good for patients.

Great and then last question.

And Laurens prepared remarks, you mentioned the unmet need for.

For the treatment of uterine fibroids I'm curious if as you from because you've been detailing the practices. If you of a better understanding of what it is the abbvie has kind of done wrong way or hence launch hasn't gone better and therefore what.

What ways could you improve with with my February to get its uptake to be.

Some of them more.

The rapid than what we've seen from the competitor.

Yes, I think it starts with a really deep understanding of the marketplace and I'll, let Laura and address Theres kind of 3 key areas that we focus on.

Leading up to the launch and we think each of those provide a significant departure from from what's.

And what's occurred previously so Lauren.

Thanks, David.

We as you have observed the competitive launches and the challenges that they face and learn from that and I think the first thing that's most important.

And that our clinical profile is really unique and uniquely meeting.

And the specific needs that prescribers.

Say that they have and this market as well of patients and so we're bringing a unique offering to this and this market. The second thing is that we are optimizing the first experience for patients.

Invested a great deal and making that first experience of positive 1.

And that's something that we learned.

What's the challenge and previous launches and then finally, we believe our field execution with having 2 teams both of which have a lot of women's health experience.

And being able to flex those teams appropriately to reach the the the breadth of targets.

And this market since it is very diffuse, but also being able to get the frequency where it's needed.

And so and those ways, we believe that we'll be able to show up differently than our competitors have and the path.

Perfect. Thanks for taking my questions.

Thanks.

Thank you.

And our next question is from Brian <unk> with Baird. Your line is open.

Hey, good morning, guys. Thanks for taking my question and congrats on a well.

The first of all of them on so far.

I guess.

Switch topics a little bit I was just wondering.

You could kind of give us some details on the on the protocol Amendment and BMD.

The monitoring and the Serene study and just kind of how to think about that going.

Going forward and just in terms of the role of relative oil looks and pregnancy prevention and how do we kind of think about the safety profile there versus the approved oral contraceptives I got.

Sort of the substantial efficacy benefit over these and U F on endometriosis, but can you help understand what.

And you see as the potential differentiation and pregnancy prevention on here. Thanks.

Yes, certainly.

Juan Camilo address that at the at the risk of saying that we don't typically comment on the FDA discussions back and forth, but when and Camilo, what can you share with us.

I think that debt.

The rest of the amendment, we follow the.

And that we received from FDA and we've submitted the.

The amended protocol to them, we expect to hear back from them soon.

And expect that to be with.

And hopefully a removal of the hold and allowing us to restart of the study with regards to the second part of your question about the.

And I think that.

As you know women with uterine fibroids and and the future within the maturities are premenopausal women and as they are considering their options for treatment for their there. The thesis that we're talking about they are also considering they are productive.

Transportation and efficient and that included the includes contraception and so the ability to have.

Debt treats the symptoms of uterine fibroids endometriosis.

And provide prevention of pregnancy is something that we've heard loud and clear from from gynecologist and for from women to.

And to be.

Pretty important differentiating factor is something that they really care about and I can tell you that the gynecologists that that's something that I've had top of mind since we started developing rather the <unk> combination tablet.

Cause.

And I can't imagine and those conversations happening in the clinic. So we feel very strongly that this is a.

The pretty important component to the future of.

Mike on <unk>.

And and the treatment of uterine fibroids and then the maturity.

Great. Thanks.

Thank you.

Thank you. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.

And Paul Your line is open.

And we cannot hear you Paul.

Please press star 1 to get back in the queue and we're going to proceed with the next question from Josh <unk> with Evercore ISI.

Hi, This is gavin on for Josh and nice quarter and thanks for taking the question just have 1.

On the provider economics for of <unk>.

The spend through the provider owned specialty pharmacies.

I believe you had mentioned that the practice economics were pretty similar to the Gnrh agonist.

And <unk>.

But given how erode and their ESP is and where it will go the lack.

Black it's priced and feel like there would be room to offer a little better economics could you just elaborate on this dynamic of it.

Yes, certainly what we have seen the the change and Asps, Laura and maybe you could address that.

Yes.

And.

So.

As I believe Youre already aware, we have contracted with.

With the clinical accounts.

And but when we did that we did that to remove any disincentive from a from an economics perspective.

Since then the.

The ASP dynamic.

<unk> for our competitors has has changed we are not affected by that.

And and.

At this point it actually improves the economic dynamic.

In favor of <unk>. So we currently do not have any plans to change.

And our contracting strategy.

<unk>.

But the way that clinics.

Chairman.

How this plays out and their clinic and their decision, making is up to them and.

And and.

And it's unclear.

Uh huh.

How much of a role that will play considering that shifting of patient.

Especially for some Medicare patients.

It may change their co pay and so offices will have to consider both dynamics and making their treatment selection.

Did that answer your question.

Yes, that's helpful. Thanks.

Thank you.

And again.

And if you have a question simply press star 1 on your telephone and we have a question from the line of Paul Choi with Goldman Sachs. Please proceed.

Okay.

Thank you sorry about earlier, just 2 quick ones from our side. Please just.

With regard to your other comments.

Patient.

And for demand for <unk> share can you, maybe just sort of comment on how youre thinking about potential.

The changes with regard to patient visit levels, just given what seems to be the changing backdrop with regard to COVID-19.

And any additional color you can say there.

And then I had a follow up question on my friend free.

Yes, I'll, let Laura and address that I think we're seeing certainly.

And patient.

<unk> dynamics I think are different and the urologist office versus the oncology office of Lauren do you want to address that yes. Thanks Paul.

And.

So I think theres 2 elements of it impact right.

The there's 2 elements of the Covid impact 1 is what you were referencing which is patients going into the clinic.

And we've essentially seen that return on our pre COVID-19.

Levels.

And so.

And we're comfortable that that dynamic is rebounding now the <unk>.

Second part is the access that we have to customers and to Dave's point that does vary between urologists and oncologists with oncologists.

Managing immuno suppressed patients they are a little more restricted at this point.

However, in both cases urologist and oncologists that access has improved and so that's why we're able now to have a higher percentage of in person details, which is more valuable and.

Allows us to have greater access to our customers.

On.

Which is important to driving demand.

Yeah.

Okay. Thanks for the additional color Lauren and then on my February I appreciate that the debt. The early sales were primarily stocking and and inventory.

I guess with regard to messaging and in the market and.

Having on sort of more fulsome presence.

Demand from the market this quarter.

For either Dave or Laura and here I guess can.

Can you, maybe just sort of reframe for us.

And the learnings from the.

And from our competitors launch and just where you will primarily be focusing on addressing questions where.

And there may have been resistance among potential prescribers for that for the generator.

And the last year and just what what are the.

On messenger and you'll be bringing to market. Thank you very much.

Well, Thanks, Paul I think 1.1 thing just for context, the real opportunity is not really for us.

The focus specifically on the <unk>.

<unk> antagonist.

And rich because of the class I think the real opportunity is.

Is to really look at those women, who are still on oral contraceptives.

And I have been failed by the first line therapy, we're looking at.

3 million women, who have been failed by their first line therapy and another.

Our total of 5 million women.

Who are seeking treatment.

We can step in and provide on a better option for those patients with our clinical profile and then specifically with the.

With our administration of 1 tablet once a day, we think that's really where the opportunity.

Lynn and.

And that is really where we think the we can unlock the full potential of this marketplace.

Our clinical profile, coupled with our 1 pill once a day it makes us.

Really the ideal choice that physicians are telling us theyre looking for and.

We think now coupled with the positive discussion.

We are having with payers, we think that the.

Payer environment will open for us.

As we hope and and the interim we certainly have all of the patient support services to support the offices and the patients along the way. So we feel very good about the ability for my February to make a significant impact on the marketplace and really provide the.

Cash and that treatment that both clinicians and patients have been waiting for.

Thank you very much.

Thank you and.

And I'm not sure and any further questions in the queue I will turn it back to day for his final comments.

Okay. Thank you look my event is at a very exciting time with 2 launches underway with differentiated therapies that can really make a meaningful difference for patients with advanced prostate cancer and with uterine fibroids.

We are very well positioned both operationally and financially to deliver strong.

And the commercial execution as well as build sustainable long term value. So thank you all and I look forward to keeping you updated on our progress.

And ladies and gentlemen, this concludes the <unk> Sciences first fiscal quarter 2021 earnings conference call. Thank you for your participation.

Strong and and you may now disconnect.