Q3 2022 Myovant Sciences Ltd Earnings Call

January 26, 2022

Good day, everyone and welcome to Miami.

Right.

Quarter of fiscal year 'twenty earnings Conference call today's call is being recorded.

This time I would like to turn the call over to Lynn Lewis.

Thanks, President and Investor Relations at <unk>.

Please go ahead.

Thank you operator, good morning, and thanks for joining us today to review the financial results of <unk> third quarter of fiscal year, 2021, and to discuss other corporate and business updates.

Joining me for today's call are Dave Marek <unk>, Chief Executive Officer unique marrow, chief financial and business Officer.

Lauren Berandino, Chief commercial officer, and Dr. Juan Camilo Arcana, Chief Medical Officer.

In addition to the press release issued earlier today.

Slides that will be presented during today's webcast are available on our Investor Relations website investors <unk> Dot com.

Today, we will be referring to our third fiscal quarter, representing the three months ended December 31, 2021, as our third quarter or Q3 throughout this presentation.

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

A discussion of these risks can be found in our SEC disclosure documents. In addition, myopia and does not undertake any obligation to update any forward looking statements made during this call.

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

Thank you Ryan and good morning, everyone.

Mike will then continue to make significant progress with our U S launches of our globex in my February during our third fiscal quarter of 2021.

<unk> recorded $54 4 million of total revenue, including $29 3 million of net product revenue.

<unk> achieved net revenues of $24 $4 million in its fourth quarter on the U S market.

Reflecting 40% sequential volume growth compared to fiscal Q2, partially offset by a lower net selling price.

<unk> generated net revenue of $2 $4 million, reflecting steadily increasing growth over each month of the fiscal third quarter.

December <unk> had captured 45% of new to brand prescription share among gnrh antagonist approved for uterine fibroids more than double the 20% share that might Banbury held only three months prior.

<unk> revenues from Gideon Richter, our international commercial partner for women's health.

Were $2 4 million.

Primarily reflecting revenues for products supplied to Richter to support their European launches.

Turning to business development and financial updates.

We're currently engaged in a formal process to assess partnership opportunities for international rights to <unk> in oncology.

<unk> on potential partners with an established European commercial presence and urology or oncology.

We remain on track towards our goal of reaching an agreement with a partner by the anticipated European Commission approval of <unk> for prostate cancer expected in the middle of this year.

In the meantime, we continue to work with the EMA through the ongoing review process and on other prelaunch activities related to pricing and reimbursement. So our chosen partner will be in a position to execute to launch shortly after regulatory approval.

Finally, we remain in a strong financial position to support <unk> and my fabri commercialization activities, while seeking to expand our pipeline.

As of December 31, <unk> had cash and committed financing of nearly $570 million.

With the start of the new calendar year I'd like to briefly discuss our goals and objectives for 2022.

Building on the strong momentum we generated last year, we expect to drive or globex growth by increasing the depth and breadth of prescribing, while increasing patient engagement.

For my February we expect to accelerate uptake in uterine fibroids and pending FDA approval to launch my Fabri for endometriosis pain, where there is also high unmet need for a large patient population searching for an effective treatment option.

Significant prescriber overlap will enable us to execute on efficient launch for this new indication if approved by leveraging the same brand. The same dose the same one pill. Once a day that is approved to treat uterine fibroids.

In addition to executing commercially we also need to build for tomorrow through pipeline expansion.

We plan to advance <unk> lifecycle opportunities.

To advance <unk>, 600, <unk> clinical development and to announce and international partnership for <unk> and oncology.

And finally, we will also continue to look externally for opportunities primarily in urology oncology in women's health to add fuel to our clinical development engine and to complement our commercial capabilities.

We're excited about the commercial momentum for <unk> and the early launch progress for my February .

Together with our upcoming clinical and regulatory milestones <unk> remains well positioned for strong commercial execution and sustainable long term growth.

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

Thank you Dave.

Today I'll provide an update on the progress we've made on the alcohol mix and my summary launches in the year.

Momentum continues to build as we and Pfizer and drive incremental adoption and ultimately work towards establishing <unk> as an androgen deprivation standard of care.

And our first year on the U S market, we recorded $57 million of net revenue.

The 11000 men were treated with <unk>.

As Dave mentioned <unk> generated $24 4 million of net revenue in fiscal Q3, reflecting 40% sequential volume growth driven by growing patient and clinician demand for <unk> and improving payer capex.

Cumulative patients on therapy has continued to steadily increase month over month.

Since the end of timber we estimate that at least 3000 additional men were treated with <unk>, bringing the total to 11000 patients through December .

<unk> patients on free and commercial drug, but excluding patients utilizing product sample.

During November we began distributing those examples while enrollment in the free trial program was discontinued at the end of the month.

Therefore, unlike prior months.

<unk> made a number of incremental patients treated in December did not include any new patients from the free trial program.

In terms of patients taking all those market research continues to suggest that isn't being utilized across the spectrum of advanced prostate cancer setting.

We initiated the sample program to provide patients and physicians the opportunity to gain experience with I'll go back and to facilitate new patient starts at the point of care immediately upon treatment decision.

Since November we have distributed over 2200 monthly samples to nearly 1000 providers with high prescribing potential.

We have received positive feedback from many providers.

And the additional convenience of having on globex at the ready for appropriate patients to trial.

And for practices that did not allow samples.

Have provided vouchers that enable patients to receive an initial months.

We'll go next footprint.

Breadth of prescribing has steadily increased since launch.

1800 treatment centers.

Events are prescribed answer two of December an increase of approximately 300 from the end of September and nearly doubling since Matt.

The reorder rate remains high at approximately 90%, which we believe demonstrates the very high satisfaction with the overall oncology treatment and prescribing experience.

The Knicks specialties prescribing <unk> since launch remains at approximately 60% urologists and 40% oncology.

Approximately 75% of total commercial volume has been dispensed via the specialty distributor channel, which those practices with in office dispensing capabilities, including large group practices hospitals, and academic centers and integrated delivery networks.

We expect this channel to remain our primary source of business going forward.

The remaining 25% of Oncotype volume was distributed via specialty pharmacy channel, which generally serves practices that do not have in office pharmacies.

Coverage continues.

Continues to improve with a 190 million lives covered across commercial and Medicare part D. As of January 2022.

Since October we obtained coverage for an additional 17 million lives, bringing commercial coverage to 81%.

D coverage to 99% of lives.

Out of pocket cost for commercial patients, which we estimate are approximately 50% of <unk> patients treated to date.

Can be reduced to as little as $10 per month, but they use a copay card.

Nearly all of the remaining <unk> patients to date are on Medicare part D plan.

With approximately half of these men eligible for either the low income subsidy or an employee group waiver plan, both of which significantly reduce patient out of pocket costs compared to the standard part D beneficiary.

For the remaining part D patients not eligible for elas or an employer plan.

Independent third party patient support foundation may be able to provide financial assistance to offset their out of pocket costs.

In closing I'd like to highlight our tremendous opportunity to redefine care for so many more men with advanced prostate cancer.

This year of the 3 million men living with this deadly disease. Approximately 300000 are projected to receive androgen deprivation therapy with approximately a 100000 initiating ADT for the first time.

We are excited about the momentum we were able to generate in our first year of launch and the opportunity for substantial future growth that lies ahead.

Now turning to my summary.

We are very pleased with the continued progress that we've made and the uterine fibroids launch.

Since the May FDA approval in mid June launch in the U S. <unk> has generated $4 1 million of net revenue more than half of which will be recorded in our most recent quarter.

Approximately 1400 women were treated with my February through November , including patients on free or commercial drug, but excluding patients utilizing samples.

This is more than double the number of patients treated through the end of September and reflects the rapidly expanding pool of prescribers, which reached 830 December .

Also encouraging was the 45% new to brand prescription share that my thumb recaptured in December among gnrh antagonist therapies FDA approved for uterine fibroid up from 20% in September .

Provider education has been a hallmark of our launch and continues to have significant impact on awareness.

Since launch the Mylan and Pfizer sales team has conducted a 134000 calls reaching 85% of our high and medium priority target prescribers.

This activity has continued to drive awareness.

Among potential prescribers aided awareness has grown from approximately 30% prelaunch to nearly 90% as of December .

Unaided awareness has also improved remarkably with two and five target prescribers now able to identify the my family brand.

Increasing awareness has clearly had a favorable impact on the <unk> launch trajectory its prescriber base and overall class growth.

New to brand prescription share is a key leading indicator for future adoption and we are proud that in the first six months of launch My February had already captured 45% share of this class.

We believe this rapid shift in share reflects the simplicity convenience and desirable clinical profiles my February as well as the effectiveness of our sales and marketing efforts.

The full potential of my fabri can only be unlocked by growing the overall uterine fibroids market and the Gnrh antagonist prescriber base.

Providers are recognizing my family's clinical profile reflected by the rapidly increasing number of prescribers and every months since launch.

So in December approximately 800 providers have prescribed might banbury at least once.

The pool of prescribers has also expanded as nearly 60% are first time gnrh antagonist prescribers for uterine fibroids.

We have also seen class growth since the <unk> launch.

The four week moving average of total gnrh antagonist prescriptions for uterine fibroids increased 81% from late June to December .

Considering that this market can be expanded with the right treatment option.

Containing high quality commercial payer coverage for my February has been a critical launch priority given approximately 85% of women who are candidates for my fabry treatment are commercially insured.

We have made extraordinary progress in the six months since our launch achieving coverage for $148 million or 83% of commercial lives and improvement of nearly 40 million lives since October .

Negotiations continue with other commercial payers that have yet to make a coverage determination and we expect coverage to continue to expand in coming months.

Just as important as having broad coverage as having high quality coverage that supports prescriber choice, while minimizing out of pocket costs for patients and other barriers to access.

Of the commercial covered lives to date, 77% have prior authorization criteria that is at parity with Oregon.

And the out of pocket cost for commercial patients can be reduced to as little as $5 per month with the use of our co pay card.

Pending FDA approval bias may 6th Paducah date, we expect to launch <unk> in endometriosis and net.

And Dmitry Aosis impacts approximately 8 million women in the U S of which $6 million experience often debilitating symptoms like pelvic pain pain during intercourse infertility, which can significantly impact quality of life.

Approximately 1 million women with symptomatic endometriosis or sale by initial therapy underscoring the high unmet need for this disease.

We have a very clear and direct strategy for endometriosis launch.

Pending FDA approval, we intend to highlight the clinical profile and leverage the same one dose one pill. Once a day approach currently approved for uterine fibroids.

Additionally, given the significant prescriber overlap between uterine fibroids and endometriosis, we plan to utilize the existing women's health sales forces and leverage prescribers familiarity with my family.

Incumbent Gnrh antagonist offer a confounding array of two brands three doses and multiple dosing intervals across uterine fibroids and endometriosis.

My summary on the other hand resembles the once daily dosing for oral contraceptive with which many women are already experienced and is often the initial therapy prescribed by gynecologist to treat these diseases.

We believe that these factors combined with accelerated payer coverage should help to support initial uptake in endometriosis is my summary is approved by the FDA for this indication.

There are approximately 5 million women in the U S systems medically fibroids, who are seeking treatment and 6 million women with symptomatic endometriosis.

These women approximately $4 million of sales by initial treatment for their disease.

While we realize that changing entrenched prescriber behavior takes time even.

<unk> been capturing a small share of this 4 million patient market will result in a significant commercial opportunity for my family.

We are off to a great start with a differentiated product that with time has the potential to change the treatment paradigm and uterine fibroids as well as in endometriosis pending FDA approval.

I'll now turn the call over to unique to review our financial results.

Thank you Lauren My comments today will focus on the highlights of our financial performance in the third fiscal quarter ending December 31 2021. Please.

Please refer to our press release and Form 10-Q issued earlier today for additional information.

Let's begin with revenue.

This is Vince at the preliminary revenue ranges, we provided earlier this month.

Rent recorded $54 4 million of total revenue for the quarter.

Q3, net product revenue was $29 3 million.

Our <unk> net revenue was $24 4 million, reflecting 40% sequential volume growth, partially offset by a decrease in net price due to a higher gross to net discount compared to Q2.

The gross to net discount for <unk> in fiscal third quarter was in the low 40% and we expect it to remain in the low to mid 40 percents for the foreseeable future.

For fiscal Q4 2021, specifically.

We anticipate the impact of gross to net discounts.

<unk> to be in line with the impact from fiscal Q3.

My family net revenue was $2 4 million.

Collecting steadily increasing demand for the differentiated clinical profile of my family along with the class growth.

We recorded $2 4 million.

Net product revenue from Gedeon Richter.

Reflecting revenues for product supply to support the European launches, a theoretical and to a lesser extent royalties.

We also recorded $25 $2 million of Pfizer collaboration revenue.

Think of $21 million related to the partial recognition of the upfront payment received from Pfizer in December 2020, and $4 $2 million related to the partial recognition of a $100 million.

Regulatory milestone payment triggered upon FDA approval of my family for uterine fibroids.

In future quarters, we will continue to amortize these milestones at the same amounts through the end of calendar year 2026, when the amortization period is scheduled to end.

Moving on to other highlights of our income statement.

Cost of product revenue for the quarter was $4 2 million.

And largely comprised of expenses related to the cost of goods sold as well as the royalty on net sales of relatively stable to Takeda.

Collaboration expense was $12 $1 million, reflecting phases, 50% share of net profits from sales of our <unk> and my family in the U S. During Q3.

R&D expenses in the third quarter 'twenty.

$25 7 million compared to $35 million for the comparable prior year period.

The decrease in R&D expenses was mainly driven by a reduction in clinical study costs as well as higher cost sharing with Pfizer for certain R&D expenses.

SG&A expenses in the third quarter was $72 1 million compared to $49 2 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, including higher personnel related costs in connection with the hiring of my rents commercial operations marketing and market access teams as well as the oncology.

<unk> and women's health sales force.

<unk> generated a net loss of $63 4 million or 68 cents per share in the third quarter of 2021 compared to a net loss of $73 8 million or 80.

<unk> 82 per share in the variety of inputs.

Looking ahead.

<unk> for the fourth fiscal quarter 2021 projected to be in line with Q3 actual spend.

Sequentially, we expect fiscal year 2022, R&D expenses to increase as compared to projected fiscal year 2021, driven by spending on <unk> lifecycle opportunities such as the phase III <unk> study as well as on post marketing requirements as agreed upon with the.

The FDA.

SG&A expenses for fourth fiscal quarter 2021, I would expect it to decline modestly from Q3 actual spending which included expenses for certain sales and marketing activities that were originally expected to be incurred in fiscal Q4.

Subsequently, we expect SG&A expenses to be higher in fiscal year 2022, compared to projected fiscal year 2021, due to increased marketing and promotional expenses to support the ongoing commercialization of our <unk>.

<unk> and my family in the U S.

We ended fiscal Q3 with total cash marketable securities and committed financing of $569 $1 million comprised of $527 $8 million of cash and marketable securities and $41 3 million.

<unk> of capacity remaining under the low cost loan facility extended to us by Sumitomo Dainippon pharma our majority shareholders.

Our cash position and potential future milestone payments, coupled with the sharing of certain level its related development and commercial expenses with Pfizer as well as the anticipated increase in <unk> and my family's revenue puts my rent in an excellent position to execute commercially.

<unk> strategies, 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 and Lauren.

In closing, we believe <unk> adoption will continue to build as breadth and depth of prescribing increases.

And as we step up patient activation efforts.

After our first year on the market. We continue to believe that our <unk> is poised to become an ADT standard of care and advanced prostate cancer, representing a significant commercial opportunity overtime.

<unk> has the potential to impact the lives of millions of women by transforming the treatment paradigm for uterine fibroids and if approved by the FDA for pain associated with endometriosis.

Our recent launch progress in uterine fibroids has been encouraging as we've been able to rapidly gain new to brand prescription share while simultaneously growing the class and the prescriber base.

We have plans to expand our pipeline this year by executing on <unk> lifecycle opportunities by advancing <unk> hundred two and by pursuing business development, which all can be supported by our strong financial position.

In addition to executing commercially in the coming months, we expect to complete multiple regulatory filings received multiple regulatory decisions.

Readout important clinical data.

And potentially initiate additional clinical studies, all of which will better position us for sustainable long term growth.

I am confident in our ability to deliver on our mission of redefining care for those who depend on us for our differentiated medicines.

And I look forward to this translating to long term value creation for shareholders.

You for your attention and I'll turn it over to Ryan to begin the Q&A session.

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

Ladies and gentlemen, as a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound key please standby only component the Q&A roster.

Our first question will come from the line of <unk> <unk> from Seb Leerink. Your line is open.

Great Thanks and morning, everybody.

I have a question for Argo VIX, perhaps could you update us on the status of your efforts negotiating with large group purchase organizations and removing disincentives for in office dispensing and do you expect these efforts to taper off anytime soon or are you going to continue it through the year.

Yes. Thank you Ralph Lauren would you like to take them.

Yes sure.

So from a GPO perspective, we have contracts in place with key GPO that enable the practices to purchase our product purchase <unk>, our specialty distribution channel and so those the contracts exist and.

Our in place and are being utilized by our count today.

Okay, great and so are there any other smaller accounts I might tag on or is it relatively stable.

It's relatively stable at this point.

Great. Thanks.

Thank you.

Top line.

Eric Joseph from Jpmorgan. Your line is open.

Yes.

Hi, good morning, Thanks for taking the questions.

First.

As on.

Are you essentially European launch and just pencil partnering considerations.

You talked a little bit about having.

Having started coming in there still.

And we ended with working Germany.

I'm curious to know whether.

Loss or led lots of Europe as one of their strategic alternatives you.

That might happen here.

And what is the relationship with Sanofi on us.

Operating leverage in occupancy in the European market.

So good morning, Eric ill, let you need to address that I believe youre, referring to the European opportunity for or go back so.

Could you take care.

Yeah, Hey, good morning, Eric.

At this point in time, you're not contemplating <unk> led launches in Europe .

We've stated before we are.

And those processes underway right now to evaluate.

<unk> partners for <unk> in the.

Ex U S markets.

And we have considerable interest in the opportunity.

As mentioned before we're also seeking partners, who have established commercial infrastructure in Europe , preferably in urology and oncology and consistent with our previous remarks, we.

Book to have a partner in place ahead of the.

You approval decision, which is expected sometime in the middle of this year.

Yeah.

Okay.

Thanks for that and just on that.

The U S launch.

You at least at the conference.

<unk> highlighted the expectation of stabilized gross to net.

Can you just talk a little bit over the rest of the how far out you're correct.

<unk> reached any guidance as to how you're thinking about pricing in the.

Outer years.

Yes.

Yes, certainly.

Can you address the gross to net outlook.

Yes sure Eric.

Good.

We expect in the foreseeable future, which should be at least till the end of calendar year 2020, due for our gross to net to be in the sort of low to mid 40 percents.

Most of our contracts typically.

Until that point in time, and then beyond the calendar year end 2022, there will be some.

Sort of renegotiations that may likely happen, but.

<unk> right now is at least until the end of 2022, we expect to be in that range.

Okay, great. Thanks for taking the questions.

Thank you.

Okay.

Our next question comes on line.

<unk> Naidoo from Cowen you may begin.

Good morning, Congrats on the progress and thanks for taking our questions.

So I guess first on our globex launch in the U S. Can you discuss a bit about the physicians who are prescribing the drug what's about the patients who are being the first to put on it any unifying characteristics. Among those patients for example, they have cardiovascular risk or.

Or anything else notable.

Lauren.

Yes, So let me do.

An analysis of our.

Claims data so keep in mind due to our distribution model we have.

Limited data.

Access.

But with the data that we have we're able to analyze the types of patients that are receiving although this today and we look at them grouped into three groups.

<unk> those with localized disease, those who have locally advanced disease than those with metastatic kidney and what we see is that about half of those patients have localized disease.

And so this means they're earlier in their disease course.

And about 35% of patients are metastatic.

Uh huh.

I have more advanced disease.

But this is very similar patient distribution to lupron.

And also generally reflective of the size of these patient groups. So that's generally how we look at the patient subsets.

We don't have access to data that allows us to assess cardiovascular risk.

We do hear anecdotally from the field that that is a consideration for physicians as they make treatment decisions.

Perfect that's very helpful.

The second question on <unk>.

Have you received the day 120 questions.

From the EMA and any notable notable issues.

If you've got one canola I'll, let you address that I know, we typically don't discuss kind of the regulatory discussions, but maybe you could provide some context in terms of our feeling on the progress there.

Yes, yes. Thank.

Thank you, Dave and Hi, Phil.

As Dave pointed out we usually don't provide that granularity.

However, I will tell you we are we remain on track for a mid 2020 this issue.

You do the math.

Knowing that the process for years.

Regulated in Europe , we are definitely positive day 120.

And we are excited to see the next steps towards the final decision.

Perfect and then.

One last regulatory question from us.

I'm going to answer it in terms of the two year BMD data that that will be filed any recent thoughts on the ability of that data to remove the limitation of duration of use from the U S label, If my memory.

Yes.

Yeah.

Similarly, as we stated before we are very excited about the data we saw from the randomized withdrawal study.

We are pretty confident on our or we believe that that data together with the rest of the data from the Liberty program have shown limited effect of my Fabri on DMD.

So we are putting together a submission that should go.

As planned in the next few weeks into the FDA. However, we cannot predict how FDA will interpret the data and then what is the likelihood of that having any impact on that ratio of treatment.

Well we are.

Putting our best case forward.

Alright, that's enough data.

Wait for the Iridium.

Alright, thanks for taking our questions and congrats again on the progress.

Yes, Thanks, Phil and just just to add onto that last response, but just remember the.

The label is one area that physicians will look for those data we also.

Certainly expect that it will be available through publications and other gains as well.

Next question please.

Our next question will come from the line of Brian <unk> from Baird. Your line is open.

Hey, good morning. Thank you for taking my question I was hoping maybe you could discuss the <unk>.

Intended submission of the Liberty randomized withdrawal study and how you think getting this added to the label could wind up impacting uptake and the ability to detail relative to <unk>.

Yes.

Long ago, maybe again.

Just kind of touch on that regarding.

How you believe prescribers will.

How important this data is to prescribers, regardless of where it ends up in the label or.

The public and then maybe.

Maybe just talk about what we hear from physicians and our promotional efforts.

So want to know why don't we start with you.

Yes, Thanks, Steve.

As Dave pointed out.

We will we will.

Eliminate the data in multiple ways right. The first one is we are providing.

Submitting to the FDA and we expect the data.

Some of the data that can be reflected in the label.

As I mentioned before if it effect duration of treatment will be an FDA decision.

With that we are proceeding with the presentation of the data and look for comprehensive and we'll look forward to also a publication.

The data, we consider a very robust in that way.

Physicians will have all the information that we will.

It would be useful to them to make their treatment treatment decisions.

As a reminder, we are the only the.

The only generates antagonist that has.

Ed.

One two year of trials that are now publicly available.

And.

And I think that.

Add another layer of confidence.

By prescribers.

The profile of my country.

Laura.

Lauren you're on mute.

Sorry from a physician perspective, we continue to hear that physicians are focused on you at year end pipelines as a long term disease and so theyre looking for therapies that match their patients' needs, which which we believe.

My summary offers a unique.

Clinical profile for those patients.

So as more data becomes available.

And once we have approval to use that promotional lever off course.

Do that.

And payers will also have access to the data as soon as that.

Available and published.

Yes, Brian one other.

Additions when we think about the spirit data.

Longer term data many times, we focus on the BMD resulted in other clinicians are very focused on that but the other part that gets a little less airtime.

What happens when you just continue my fabri and.

What we see as the symptomatology returns back very quickly for these women and so I think thats a consideration as physicians look to make treatment decisions down the road and why the BMD data is important but also.

What happens when you withdraw and then Reinitiate My February of course, the efficacy returns fairly rapidly. So that's another key part of that dataset.

Great. Thanks, that's very helpful.

Yeah.

Will come from the line of Madhu Kumar from Goldman Sachs You may begin.

Hey, Thanks for taking our question so kind of following up on that last comment about the withdrawal studies in kind of commercial practice, what kind of.

Feedback are you getting on the idea of kind of this two year period of use speed a limitation to uptake in that people don't want to have to go onto a therapy and then come off of that didn't have like their disease rebound like how much of that is a barrier to that and kind of following up on buzz kill with Brian's question is how much would it kind of removal of the limitation of use.

Resolve that issue.

Yes, Juan Camilo as a physician I know you.

Phases.

Types of decisions I'll, let you talk about your perception of how physicians would view.

Again the.

Long term considerations for uterine fibroids.

Yeah. Thanks, Dave.

Hi, Matt do I think that there are multiple multiple things that are considered by physicians that treat women with uterine fibroids I think got.

One thing that's been very clear now.

Peco guidelines have been updated as that what is very important is that for women to have multiple options for treatment.

Until recently the options were limited some of the medical treatment options had limited efficacy like contraceptives or.

Answered.

And therefore, the addition of the Gnrh antagonist adds another layer.

No effective treatments that provide opportunity for women, but we've heard from from our market research is that right.

Women in general would rather not have major surgery.

And the.

The cornerstone of treatment of uterine fibroids with my mechanism hysterectomy.

From a.

Treating sufficient perspective, I think that that is the.

<unk> that is.

My family brings to the table.

Other.

Options that provide predictable efficacy and safety in.

It allows women to to delay or prevent the need for surgery.

Okay, Great and one follow up question for unique how should we think about you had good color on fiscal year 'twenty two.

R&D and SG&A spend how should we think about the growth of those relative to the growth from fiscal 'twenty to fiscal 'twenty one.

Yeah. Thanks for.

The question will be providing more color on the dimensional elevation of that growth in our fiscal Q4 call in may as we sort of look through the end of this year as well as.

Ill close out activities for this year in Ireland to place it at.

At that point, we'll be in a better position to give you.

The conventionalized <unk> of that increase.

Okay. Thank you.

And our last question will come from the line of Kevin Clark Gardner from Evercore ISI. Your line is open.

Hey, Thanks for taking the questions just had a couple.

<unk>.

Harrison DLD recently issued guidance states payers must cover FDA approved contraceptives with no out of pocket costs once the serene indication on the label with this guidance likely apply to all my fabry patients.

Juan Camilo.

Yes Gavin.

Good morning, So first let me just say that we are very excited about our assuming the study we believe that.

Having.

Product.

<unk> provides the treatment for uterine fibroids and hopefully the materials, which if approved that also provides contraception will be very meaningful for prescribers and for patients.

This is contraception is something that it's.

The consideration that is top of mind for women in this retroactive AIDS.

Doug.

Suffered you didn't previously endometriosis and therefore, we believe.

That successful screening study would be a critical differentiator, where my friend break.

Yes.

As you pointed out.

The regulations or the rules require that all of at least one contraceptive specific class is covered.

No cost for the patient.

Certainly has been a consideration.

But we will wait until we have the data in there. We will we will go through the process of assessing that to determine the full implication of.

Scott if applicable for my memory, but we remain very excited about the <unk> III study and how the value is that it will break.

Ascribed to send for patients.

Okay.

Yeah got it and there are also $3 5 billion in potential tiered sales milestones from Pfizer under the partnership can you share any more details on what the tier a or b sales thresholds or what the milestone payments are when it's possible that any of these milestones could be reached.

Yes unique would you like to discuss the.

I know, we arent providing specific numbers on the tiers, but maybe you can add some color there.

Yes. Thanks.

Yes.

We have not provided any details in terms of the peers.

On these milestones I think when you look at the three six and typically.

And then spread it across generally available for five years, you can probably estimate where those.

And in regards to your second sort of follow up as to when we would likely expect to achieve those gears.

I think it's still too early given that we are lunches are just gaining traction.

But my family.

So at this point, it's a little early to sort of indicate when.

And we would have that.

Achievement of those Skus.

Yeah got it thanks, and maybe one last one on <unk> are you bigger urology and oncology practices of dumping formal preferences for our <unk>. Other other gnrh agents. So it could be kind of listing it as a preferred agent in their EMR prescribed system or alternatively are they included in their system with.

Parity access to the other agents the Eagle decision up to the prescribers.

Yes.

Thank you Kevin Laura.

So we don't have complete transparency into the EMR systems.

We seek feedback from our customers about.

Their preferences, and how they're utilizing <unk> and it seems that for certain patient types. They do you have a preference to to start with I'll go back.

But.

But it is.

The visualized treatment decision with each patient.

Operator are there further questions.

Thank you and I'm not showing any further questions at this time.

The call over to David for any closing remarks.

Well. Thank you as you can hear today, we're very encouraged by the progress that we've made on our <unk> and micro <unk>.

We're energized by the tremendous remaining commercial opportunity for both brands.

We're also very well positioned to deliver strong commercial execution, while building sustainable long term value through pipeline expansion. So thank you and I look forward to keeping you updated on our progress have a good day.

Ladies and gentlemen. This concludes my event Sciences third fiscal quarter 2021 earnings Conference call. Thank you for your participation.

May now disconnect everyone have a great day.

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Good day, everyone and welcome to my Life Sciences third quarter of fiscal year 'twenty 'twenty. One earnings conference call. Today's call is being recorded at this time I'll like to turn the call over to Lance <unk> Vice President Investor Relations. Please go ahead.

Thank you operator, good morning, and thanks for joining us today to review the financial results of my events third quarter of fiscal year, 2021, and to discuss other corporate and business updates.

Joining me for today's call are Dave marriage, My events, Chief Executive Officer unique marrow, chief financial and business Officer.

Lauren Berandino, Chief commercial officer, and Dr. Juan Camilo Arcana, Chief Medical Officer.

In addition to the press release issued earlier today.

Slides that will be presented during today's webcast are available on our Investor Relations website investors <unk> Dot com.

Today, we will be referring to our third fiscal quarter, representing the three months ended December 31, 2021, and our third quarter or Q3 throughout this presentation.

During this conference call, we will be making forward looking statements. These include plans and expectations with respect to our products product candidates strategy's opportunity then financials, all of which involve certain assumptions risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements and.

A discussion of these risks can be found in our SEC disclosure documents. In addition, my event does not undertake any obligation to update any forward looking statements made during this call.

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

Thank you Ryan and good morning, everyone.

Mike will then continue to make significant progress with our U S launches of <unk> in my February during our third fiscal quarter of 2021.

Mile that recorded $54 $4 million of total revenue, including $29 3 million of net product revenue.

<unk> achieved net revenues of $24 $4 million in its fourth quarter on the U S market.

Reflecting 40% sequential volume growth compared to fiscal Q2, partially offset by a lower net selling price.

<unk> generated net revenue of $2 $4 million, reflecting steadily increasing growth over each month of the fiscal third quarter.

December my temporary had captured 45% of new to brand prescription share among gnrh antagonist approved for uterine fibroids more than double the 20% share that might bembry held only three months prior.

<unk> revenues from Gideon Richter, our international commercial partner for women's health were $2 $4 million.

Primarily reflecting revenues for product supply to Richter to support their European launches.