Q1 2023 Myovant Sciences Ltd Earnings Call
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Good day, everyone and welcome to <unk> Sciences first quarter of fiscal year 2022 earnings conference call.
Today's call is being recorded.
At this time I would like to turn the call over to unique mirror Chief financial and business Officer at My event. Please go ahead.
Thank you operator.
Good afternoon.
Thank you for joining us today to discuss my around corporate update and review.
The financial results of my runs first quarter for fiscal year 2022.
Joining me for today's call are Dave Merck Myron, Chief Executive Officer, Lauren Man you know.
Chief commercial officer, and Doctor Guan Camilo, our hurdle Chief Medical Officer.
In addition to the press release issued earlier today the slides presented during today's webcast will be available on our Investor Relations website investors <unk> com after today's call.
Today's even get us into our first fiscal quarter.
Renting the three months ended June 2022 is the first quarter or Q1 throughout this presentation.
During this conference call, we will be making forward looking statements. These include plans and expectations.
Respect to a broader product candidates strategies of board committees and finance all.
All of which involve certain assumptions risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.
A description of these risks can be found.
The disclosure documents.
In addition, my rent does not undertake any obligation to update any forward looking statements made during this call.
I will now turn the call over to Dave Marek <unk>, Chief Executive Officer, Dave.
Thank you unique and good afternoon, everyone.
Miles out to 2022 fiscal year is off to a strong start marked by significant volume driven growth for both <unk> and my family.
And with regulatory advances that enable us to reach more patients with our differentiated medicine.
And our first quarter <unk> recorded $116 $5 million.
Of total net revenues, including $41 4 million of net product revenue.
We continue to reach more men with advanced prostate cancer through continued adoption of our <unk> across a broad range of patient types and treatment settings.
<unk> and quarterly sequential demand volume growth of 26%.
With my family, we continue to grow the Gnrh antagonist class for the treatment of uterine fibroids and we're proud that my memory is now the number one prescribed gnrh therapy with leadership in both new to brand and total prescription shares.
Outside the U S. <unk> is now launched in 19 European countries, making it more widely available for women with uterine fibroids.
And we've made great progress with our regulatory efforts.
We are pleased to be in labeling discussions with the FDA with respect to our mice S. MDA for endometriosis associated pain and.
And expect a decision from the FDA by the Purdue for goal date of August six.
We remain confident in the clinical profile of my memory and its potential to become a meaningfully differentiated therapeutic option for women with endometriosis.
We will continue to work closely with the FDA to support the advancement of our SMB yet.
In June we announced that the FDA accepted for review our F&B April my memory based on two year safety and efficacy data from.
From the phase III Liberty randomized withdrawal study.
These study results show the longer term benefit my fabri can potentially have on treating women's uterine fibroids symptom.
The FDA set of Paducah goal date of January 29, 2023.
Moving to oncology I am excited to share that <unk> is now approved in the United Kingdom as the first and only oral androgen deprivation therapy for adult patients with advanced hormone sensitive prostate cancer.
This approval coupled with the European Commission approval in April will.
We will bring this meaningful therapy to more patients across Europe .
And finally, our strategic partnerships continue to be a value driver for myopia.
This included a $50 million upfront payment received from a cord in Q1 for the exclusive license agreement to commercialize <unk> in Europe .
And despite the challenging macroeconomic environment.
We ended the quarter in a strong financial position with cash and committed financing of $400 million.
Enabling us to fully support or <unk> and my fabri commercialization activities, while also seeking to expand our pipeline.
Now I'll turn the call over to Loren for more in depth review of our commercial performance.
Thank you Dave.
Today I'll provide an update on the performance of our <unk> and our progress on the my summary launched in the U S.
Let's start with our <unk> performance.
Well go next continued to demonstrate strong growth on multiple fronts in fiscal Q1.
Further advancing our progress in establishing it as an androgen deprivation standard of care for advanced prostate cancer.
Since launching in January of 2021, approximately 18000 men have now been treated with <unk>.
Australia continued growth of patient and prescriber demand.
Although that's delivered $36 million of net product revenues in Q1.
Proud to report that this quarter, we also drove 26% sequential commercial demand volume growth.
Demonstrating expansion of <unk> utilization.
As we look at the quarterly net sales trend you can see the revenue we achieved in Q1 represents 22% quarter over quarter growth.
The broad coverage, we've established Borgata continues to play an important role in the brand success by enabling affordable patient access.
In fact, three out of quotations.
Paying less than $60 out of pocket per month.
Our gross to net remained within the previously stated range of low to mid 40, and we expect to stay within this range this fiscal year.
Due to quarterly fluctuations, we were near the upper end of this range for this quarter.
Leading indicators such as new patient starts and account growth continued to be strong, giving us confidence that we will continue to see growth with this brand in the future.
Let's talk a bit more about these factors.
Well go ahead to new patient starts grew this quarter with an additional 3500 men initiating or go back in Q1, representing a 24% increase compared to last quarter and bringing the total estimated patients treated since launch to 18000.
It's important to note that these patients represent a broad range of patient types.
An analysis of our specialty pharmacy and claims data shows over hospital salvage patients have clinically localized disease, while 30% of metastatic prostate cancer.
Which is consistent with what we see in the ADC market overall.
This analysis confirms that prescribers see the benefit of the <unk> clinical profile across a spectrum of advanced prostate cancer patients.
Yeah.
As you can see in the Pie chart. Our account volume distribution is very similar to what we reported last quarter with about 80% of our Covid business coming from the dispensing clinics academic and integrated delivery network accounts combined.
And this is consistent with what we see from the ADP market overall.
Almost half of our volume comes from dispensing clinics, which are primarily driven by urologists and we've seen accelerated growth in this segment with 26% growth this quarter versus the 11% we reported last quarter.
The epidemic IBM segment is driving 34% of our business and is primarily driven by oncologists.
This segment also continued to see substantial growth with 22% in Q1.
Most importantly, our growth overall across all segment has accelerated with 26% volume growth this quarter versus the 18% we reported last quarter.
We're seeing continued expansion of the number of accounts as well with over 2000 treatment centers, having utilized <unk> to date.
This collectively demonstrates that our business is well balanced across prescriber and account types as well as across the spectrum of patients.
And remember with 300000 men being treated with an ADT each year, there continues to be tremendous opportunity for us to expand our impact and to help many more than that experienced the benefits of <unk> in the future.
Now turning to the launch update for my summary.
Q1 was another milestone quarter.
Within the class of generates therapies approved for treatment of uterine fibroids, we continues to be the market leader in new to brand prescriptions and have now also become the market leader in total prescriptions, capturing 51% total prescription share.
Over 5800 women have been treated with my family since launch, reflecting the growing momentum we're seeing with this brand.
As we've previously stated we believe that in order to change the treatment paradigm, it's imperative that we grow the gnrh class.
Since the launch of my fan break in June of 2021, the total prescription volume for generates antagonist in uterine fibroids has grown by 180%.
This demonstrates that my summary is expanding the patient population that prescribers believe will benefit from this class of treatment.
And our first quarter, our commercial demand increased by over 50% and we recognized $4 million of net revenues.
My family has now been used to treat 5800 patients since launch with about 2400, new patients starting treatment with my summary in Q1, which represents a sequential quarterly increase of 71%.
All of these patients 95% are new to receiving gnrh therapy.
<unk> that my summary, differentiated clinical profile and our commercial execution is broadening the patient population receiving this class treatment.
A key part of our strategy since launch has been making my memory in this asset.
We continue to benefit from the broad coverage, we've established with 94% of commercial lives covered and 75% of these commercial patients are paying $5 or less out of pocket per months.
Last quarter, we announced that we became the market leader in new to brand prescriptions for Gnrh therapy approved for uterine fibroids.
As you can see in the graph on the left we have continued our leadership in MPLX and on the right. You can see that we have now crossed the threshold to become the market leader in total prescriptions as well with a 51% share of Prs.
The speed with which my family has become the market leader is impressive.
It took six months post approval to cross the 50% threshold and MD Rx and now at a year post launch we have crossed the threshold on <unk> as well.
This demonstrates that our differentiated profile is resonating with our customers and then our commercial strategy and field execution have been impactful.
For these reasons, we remain steadfast in our belief that we will continue to change the treatment paradigm and provide more women with uterine fibroids and effective treatment for their heavy menstrual bleeding in the future.
In addition to leading our market share my summary is helping to drive the expansion of use of Gnrh antagonist overall in uterine fibroids.
In our last earnings call, we reported that the Gnrh antagonist market had grown by 137% since my summary launch and now we are proud to report that goes has further expanded to 180%.
In addition to increasing the overall class volume My family is also continuing to attract new prescribers to the class.
Over 2400, Hcp's have now prescribed my family, which is a 41% increase over what was reported last quarter.
And for 61% of these prescribers my family was the first gnrh antagonist. They have written for uterine fibroids.
Ultimately its class growth that will lead to reaching far more women, who can benefit from this product and the market trend shows that my family is continuing to serve as a catalyst for continued class expansion in uterine fibroids.
H M guidelines emphasize the importance of gynecologist utilizing shared decision, making with their patients when making a treatment decision and.
Our research shows that many women with uterine fibroids wants to play an active role in selecting a treatment, but like the information needed to do so.
Additionally, our research shows that when a patient requests a specific treatment. The majority of gynecologists are likely to fulfill that request.
With this in mind in mid June we launched a multichannel consumer campaign, leveraging targeted media to drive increased patient awareness and engagement.
The perfectly imperfect life campaign is designed to efficiently reach those who most resonate with its messages and are most likely to take action.
While very early initial indicators are already showing an impact on consumer activity and we believe that patient activation is an important part of our strategy to redefine care in uterine fibroids.
We expect that patient activation through this campaign will continue to drive patients to engage with their ACP partners on treatment options for uterine fibroids and accelerate my Thunder utilization and further growth in the class overall.
As we've discussed my family is already evolving theater in fibroids market and changing the treatment paradigm.
Our progress to date and the building momentum drives our continued confidence that over time, we will be able to advance and redefining care for women with uterine fibroids.
Shifting gears now to endometriosis.
As you know our my summary S. NDA is currently under review for endometriosis associated pain.
Endometriosis is a significant opportunity given the unmet need that remains for these patients.
It impacts approximately 8 million women in the U S of which 6 million experienced often debilitating symptoms, which can significantly impact their quality of life.
This underscores the high unmet need for this disease.
When we ask that oncologists and patients what theyre looking for in a treatment for endometriosis associated pain, they say that they want medical treatments that.
Our effective perhaps reducing the need for opioids.
Reduced the need for surgery.
Tolerable safety profile, and our affordable and easy to access.
Shouldn't the FDA granted approval by the Paducah date, we're prepared to launch my Fabry in endometriosis in August .
This launch will have significant synergies both from a strategic and execution perspective, with our current uterine fibroid efforts, enabling us to accelerate quickly into this new market, while continuing to shape the treatment paradigm and uterine fibroids as well.
I will now turn the call over to unique to provide a financial review.
Thank you Lauren Michael.
My comments today will focus on the highlights of our financial performance in the first quarter.
Please refer to our press release and Form 10-Q issued earlier today for additional information.
Let's begin with revenue <unk> recorded $116 5 million in total revenues in the first quarter.
Q1, net product revenue was $41 4 billion.
<unk> revenue was 36 million, reflecting 22% quarterly sequential net sales growth and 26% quarterly sequential commercial banker wasn't good.
The gross to net deduction for <unk>, because the first quarter was approximately 44%, which was near the upper end of our expected range due to quarterly fluctuations in timing of Medicare part D rebates.
As Lauren mentioned.
Continue to expect <unk> gross to net deductions to be in the low to mid 40% for this fiscal year.
<unk> net revenue was fulfilled for the first quarter, reflecting 54% quarterly sequential commercial demand volume growth.
Consistent with the prior quarter, we recorded $25 1 million of Pfizer collaboration revenue, representing 21 billion related to the partial recognition of the upfront payments.
<unk> from Pfizer and $4 1 million related to the partial recognition of 100 million dollar uterine fibroids regulatory milestone payments.
For the first quarter, we also recorded $15 million of a correlation to revenue which consisted of the upfront payment. We received from the court in late 2022.
Moving on to the other highlights of our income statement.
Cost of product revenue for the first quarter was $4 9 billion largely comprised of expenses related to the cost of goods sold as well as royalties on net sales of <unk> payable to Takeda.
Collaboration expense for the first quarter was $18 million, reflecting places 50% share of net profits from sales of <unk> and my family in the U S.
R&D expense in the first quarter was $23 9 billion compared to $30 9 million for the comparable prior year period.
The decrease primarily reflects a reduction in clinical study costs due to the completion and wind down of my run phase III Liberty hero and critics clinical study.
SG&A expense in the first quarter was $79 million compared to $61 2 million for the comparable prior year period.
The increase primarily reflects higher expenses to support <unk> and my friend pre commercialization activities in the U S, including higher personnel related costs.
That division cost, particularly for my family as well as a banker fee associated with your core licensing.
Income tax expense in the first quarter was $8 2 million compared to 900000 as the comparable prior year period. The increase was driven primarily by the implementation of the amendment to internal revenue code section 174 pertaining to the amortization of R&D expenditures.
These amendments became applicable for my rent during the first quarter.
We expect our total tax expense for fiscal 2020 to be approximately $23 million to $25 million.
Maryland generated a net loss of $21 2 million in the first quarter.
On a per share basis net loss was <unk> 22 cents for the quarter.
Looking ahead, we expect.
R&D expenses in the future quarters of fiscal 2022 to be higher than the first quarter driven largely by spending on rail haulage lifecycle opportunities such as the phase III <unk> studies as well as a post marketing requirement as agreed upon with the FDA.
SG&A expenses in future quarters of fiscal 2022 are expected to be higher than the first quarter, driven largely by marketing and promotional expenses to support the ongoing commercialization of our <unk> and my family in the U S, including annualized vision of my family marketing and promotional.
Spain and targeted patient activation, primarily for my family.
Despite the challenging overall macroeconomic environment Marlins balance sheet remains strong.
We ended the first quarter with total cash marketable securities and committed financing of 400 billion comprised of $358 7 million of cash and marketable securities and $41 3 million of capacity remaining under the loan facility extended to us by Sumitomo pharma majority shareholders.
Our current liquidity position, coupled with additional potential future milestone payments from our collaboration and commercialization partners.
Sharing with certain regulatory related development and commercial expenses with Pfizer as well as the anticipated increase in our <unk> and <unk> revenues puts <unk> in an excellent financial position to successfully deliver on our key growth drivers.
I'll now turn it back over to Dave for key closing remark.
Thank you unique and Lauren.
We believe <unk> is well positioned to demonstrate strong performance throughout 2022.
We're focused on delivering for today as we continue to drive broad adoption of <unk> across patient types and treatment settings, as we advance our aspiration to create a new standard of care and advanced prostate cancer.
For my February our differentiated clinical profile and commercial execution are helping us to extend market leadership, while expanding the gnrh antagonist class as.
As we look to redefining care for women with uterine fibroids.
Our strategic partnerships outside of the U S will continue to expand our patient impact globally as we grow our reach in Europe and Canada.
Our strong balance sheet allows us to continue driving commercial execution, while building for tomorrow.
We're engaging with the FDA in labeling discussions for my summary for endometriosis associated pain and look forward to the Fda's decision on our S. MBA by its August six <unk> date.
We remain confident in our application and if approved we look forward to bringing this meaningful therapy to patients later this quarter.
We have additional exciting milestones ahead and.
And as previously mentioned, we intend to share details on potential new pipeline programs later this year.
Thank you for your attention and I'll turn the call over to the operator to begin the Q&A session.
Thank you, ladies and gentlemen to ask a question at this time, you will need to press star one one on you touched on the phone.
Please standby, while we compile the Q&A roster.
No first question coming from the line of Phil Nadeau with Cowen Your line is open.
Good evening and congrats on the progress and thanks for taking our questions.
First David one on the endometriosis label expansion that you just referred to.
Sorry, if ive got any more information on the deficiencies that the FDA had identified it as part of communication and.
You might've been wavering negotiations does it now seem like any deficiencies have been resolved.
Thanks Bill.
Juan Camilo address that yes.
Yes, Phil as you know, we we don't usually consider appropriate commenting on our ongoing discussions with the FDA what would be reporting is that we have entered a labeling negotiations.
Continue to collaborate with the FDA through their review.
Remained very confident in the profile of my fabri and as new indication and look forward to the FDA, making their final decision on.
On the <unk>.
Great. That's helpful and then secondly on the launch.
Perfect.
August .
The rate at which you capture number one share in uterine fibroids is been compressive could we expect the same trajectory of share gains in endometriosis are there any unique features of the endometriosis market.
That would.
Nick.
The uptake of my number either faster or slower.
Well I think Lauren I'll, let you address that.
Just as a kind of a lead and we're really excited about the potential if we do get approved in endometriosis. We think a lot of the same characteristics that the customer base is looking for in uterine fibroids parallels to what Theyre looking for in endometriosis, Lauren I'll, let you add some additional color to that.
Yes.
Excited about the opportunities should the FDA grant our approval and our team is prepared for that launch.
We believe it is.
It's a different market, so, but our clinical profile is favorable in that market. So we're excited about.
About the opportunity. Additionally, because we have already established my summary for uterine fibroids. We think there are some factors that are beneficial that set us up positively in endometriosis.
And that is number one from a payer perspective.
We already have payer coverage established where you're in fibroids and this would be considered a line extension. So we believe we can move quickly to secure payer coverage.
We've got a base of prescribers that have experience with my summary, now and we think that.
Since their experience has been positive that that will translate well to treating their endometriosis patients and then.
Finally.
We think that.
There is tremendous synergy here across both indications because theres high overlap of the prescribers.
And so therefore from a from a field perspective, there's tremendous synergy and that will be able to realize the opportunity quickly.
That's great.
Our next question from us on that.
Taxes, I think you said $23 million to $25 million of taxes and as we're entering two could you remind us why you your taxes.
Turning to I understand the prepared remarks.
Whether we should model taxes for future years, even if.
Marvin has not achieved profitability.
Yes unique yeah. Thanks.
I mean I think.
Both the prepared remarks, and I think it will be seen as a growth company is that.
Now with the section 174 Amendment.
Being more of a possibility that its still legislation that could therefore this.
Amendment to later years, but we've taken the sort of conservative and prudent approach to.
Booked taxes bird that we also have a policy of doing.
Sort of our deferred tax we have a full.
It's sort of valuation reserve for that.
When you combine those to fill the products appropriate to start booking the taxes for fiscal 'twenty. Two in line with certified exposure now as regards to the outer years, we still have to determine that depending on the amendments applicability as well as our sort of.
Taxable income in those years, where it needs to be talked we should give the guidance for this year is that we have visibility to right now.
Perfect. That's very helpful. Thanks for taking my questions.
Okay.
Thank you one moment for our next question.
And our next question coming from the line of Brian <unk> with Baird. Your line is open.
Hey, good afternoon, everyone. Thank you for taking my question I was hoping you could help us understand how important you think the SMB to include the two year safety data from Liberty is maybe you could just.
Talk through how you think about potentially differentiate <unk> in Oregon, and just how you think that impacts any sort of.
Near term commercial ramp up thanks.
Why don't I start with Juan Camilo, and then Loren if you could add on.
Yeah, Thanks, Dave and Hi, Brian I think that.
Maybe we should just remember what the data from the randomized withdrawal study showed.
This was the second year of our Liberty program.
And that.
<unk>, we re randomized patients into continuing on therapy with my family or taking placebo and we demonstrated how stopping therapy in the placebo group led to returning of heavy menstrual bleeding and how re treating this patient wear.
We regain the controls that we have already seen therefore, demonstrating that the long term treatment with my family.
<unk> efficacy.
We've submitted the data well.
We also generated additional safety data for the long term, including bone density. So we provided the data to FDA and of course pending the review we look for capturing some of those concepts about efficacy and safety for the longer term.
In the label.
I'll also remind you that this is the only program that has at least for now showed two year data.
Five years for a gnrh antagonist.
Yes, I think also when you look at that Brian in terms of how it matches to uterine fibroids, we know thats, a chronic condition and therefore from the very outset, we were looking to.
Establish a program that would help clinicians understand if they were going to treat longer term.
If they could have.
Therapeutic option that could extend that so.
And then from a competitive perspective Laurent.
I mean.
<unk>.
We're always careful when things under review with FDA, but I would say that it would be a differentiator from a competitive perspective were we to get this in our label and enable us to speak to the long term use of the product.
And the efficacy and safety profile that comes along with that.
Great. Thanks, and maybe just as a quick follow up I mean, it's obviously a two year study. So maybe it doesn't address the question in terms of the limitation on label, but is there any thought about a way to eventually get around the 24 month limitation of use do you think that's feasible or do you think the continued bone loss.
It's a measure of risk enough.
Thats helpful.
Yes of course that is top of mind to us Brian .
We are looking at how we could potentially get to get to that we Tony provided the two year data for the uterine Fibroid study we will in.
In the future.
As we've said before provide the two year data for the endometriosis if it were to get approved by the FDA for endometriosis in the coming weeks.
But we also are as you know running now.
I will start running a pause post marketing.
Requirement by FDA that will get us up to four years of data BMD data with my family and we believe that all of that data combined may potential in the future allow us to have an impact on the <unk>.
Duration of use but again, it's hard to two.
Ah speculate of what the FDA will think until we have the data we're able to provide it but it's something we think.
Constantly on how to.
Thanks, I'll address it.
Alright, Thank you guys.
Okay.
Thank you one for next question.
And our next question coming from the line of Eric Joseph with Jpmorgan. Your line is open.
Hi afternoon, thanks for taking the questions.
Just a couple of my sundry it sounds like you're expecting a shorter peer review cycle in endometriosis assuming approval.
How quickly do you expect in <unk>.
<unk> has to be a contributor to total by February uptake and where you have visibility on uptake between the two indications.
Endometriosis and uterine fibroids.
And then if I could.
Try to follow up on.
What a label might look like.
And these ongoing labeling discussions like that.
Current U S label already has words for key.
And the duration limitation is it safe to assume that the currently will sort of lower.
In terms of.
Sort of warning language is it possible that endometriosis might lead to a more restrictive or conservative label or.
Is it really more trying to create.
Some relaxing of these criteria.
In endometriosis thanks.
Yes, well. Thank you Eric I think regarding any speculation on the label as you know, we really don't want to anticipate.
Where FDA might go.
Juan Camilo mentioned discussions are underway with FDA in.
They will make their assessment on endometriosis.
If we were to get endometriosis approved as mentioned we think that.
There is really a strong foundation of prescribing that already exist remember one of the key benefits and our plan regarding my February was the same brand the same dose.
The same.
One pill once a day is simplicity.
Physicians are accustomed to in uterine fibroids, if approved could be applied to endometriosis, we think that's a huge advantage for.
Gynecologist, who really value simplicity of dosing and the experience that they've gained on uterine fibroids. We believe can easily transfer over to endometriosis. So we're very excited about the launch potential if we get to that point.
We think the opportunity to really help women with uterine fibroids.
Is very significant for us.
Okay.
And in terms of.
Yes, I guess visibility on uptake.
<unk>.
Yes.
We either fibroids endometriosis is there sort of the ability to do that.
Yeah, I mean, I think from the standpoint of.
Physician.
Awareness of my February its already very high for uterine fibroids and that will translate over pretty significantly to endometriosis Lauren maybe you want to talk about <unk>.
Discussions with payers and other potential levers for uptake.
Eric just to clarify is this a question around the data the transparency of the data between the indications is that what youre asking.
I believe that's what you were asking so.
We will have the ability.
To separate out the data.
But it will it will require more analysis than it has so far so of course, having one product with a single indication every prescription we know is for that indication in the future will need to do additional claims analysis and then apply that to the prescription data.
But we will be able to have visibility.
Does that answer your question.
We may have lost there yes.
Yes.
Yes, Hey, Jason with itself from the Q1 moment for our next question.
Our next question coming from the line of Linda Kumar with Goldman Sachs. Your line is open.
Yeah, Hey, thanks for taking our questions are first one is really on cash runway. So how are you thinking about kind of the ongoing cash burn through the potential launch in the endometriosis.
And kind of the runway given the the burn this quarter kind of excluding the acquired.
Recognition of revenue.
Yes.
I'll start and then I'll turn it over to unique I think one thing to remember if we are approved for endometriosis. The efficiencies that we really have with our current <unk> promotion given it's the same largely the same physician base.
We have no plans to expand the field force or any other.
Significant activity is around that so.
When you referenced endometriosis, just remember that's a very efficient.
Would be a very efficient launch for us and fit within our commercial engine that we have now unique.
Just to give color I think you will notice our net cash burn of about $75 million from the financials of course, we've benefited from the receipt of the accord upfront payment.
<unk>.
Sort of take that back it's about 120 <unk> cash burn are typically in the first quarter of fiscal year to be have a higher cash burn because thats. When we have personnel related payments cloud when I look at the remainder of the year I think we feel pretty comfortable with the cash that we have that.
We will be able to resource allocation.
<unk> for endometriosis uterine fibroids, and then of course, our <unk> and then.
Because we do want to flag that I think should endometriosis get approved in August we would expect $100 million milestone.
Coming from Pfizer, our wave of that is also factored into our overall cash flow forecast.
But.
With the Pfizer cost shared with the milestone payments, we have we again feel very comfortable in our financial position our balance sheet strength for continuing on a key driver for this fiscal year.
Okay, great and so the other question was around or Dolby in kind of the current quarter. So housekeeping things I kind of go forward trajectory of organic growth given what you've seen in the last few quarters and kind of like the radar.
Revenue growth over the next few quarters.
Well, we haven't provided guidance for the remainder of this year as you know Madhu, but we're very excited about the continued quarter to quarter new patient starts we see as Lauren mentioned, we took another significant step up to 18000 patients for our <unk> for this quarter we're at.
Adding more accounts and we continue to see broad adoption across both treatment settings.
As well as patient types. So.
We are very optimistic about the continued momentum that we have and.
We're very excited about how this year is shaping up for <unk>.
Okay, great. Thanks, so much.
Thank you Madhu.
Thank you one moment our next question.
And our next question coming from the line of Brian Lewis with SBB Securities. Your line is open.
Great. Good afternoon. So one question from my son, Brian and then I'll switch to <unk>. So for my son, Brie could you give us a little more detail on how its gross to net might evolve for the remainder of the year, particularly assuming the August to do if it goes through and my friend Barry gets approved.
Dimitrios.
Lauren do you want to take that.
Yeah, so from a gross to net perspective.
Our gross to net is primarily driven by our strategy to make.
Our product easy to access.
<unk>.
Great first experience for both physicians and for patients and so we continue to have that strategy and believe that's important.
At this point in our growth trajectory in order to continue to gain physician experience with with the product and uterine fibroids today and hopefully in endometriosis tomorrow.
So.
As far as guidance on the actual gross to net I'll leave that to unique yes.
I know my family is still.
Sort of just covering up getting beyond one year. So have you done.
Feel comfortable giving a guidance as yet there are still fluctuations that are happening the only color I led towards a lot of incentive as you can imagine my family right now the big drivers of gross to net unlike although VIX, our commercial rebates and co pays and as Loren said, our focus right now is on.
<unk>.
Sort of patient accumulation, making sure patients.
Slide and over time that.
Those elements should improve but we still need more time to be able to sort of see through.
The trends of that and then come with our guidance, which we have done for robotics with Nokia for my family.
Got it helpful and fair.
Argo VIX I was also curious I know you walked us through the distribution of account types that are using in prescribing of <unk> academic centers and dispensing clinics et cetera. I was curious in your view do you think the relative share of these different stakeholders could stay the same or a credit shift going forward.
Good morning.
Yes, very good question.
We continue to see I mean, I provided the growth rates.
For the quarter.
I will say that as far as.
Where we see the.
The strongest trajectory would be with our urology dispensing clinics.
So I don't have a crystal ball I can't tell you what the what the shareholders like in the future.
The dispensing clinics in the academic idea and our biggest growth drivers but.
Sensing clinics might outpace in the longer term.
<unk> rollout when you think about the.
Utilization by Urologists for a lot of the new start patients.
We really are very pleased that we are having such strong uptake with new starts.
Men, who are just starting ADT therapy, because we really believe that will pull through from urologists to oncologists over time. So we think that will help us not only with urologists now, but even help accelerate but oncologist overtime.
Thank you one moment our next question.
Okay.
And our next question coming from the line of Kevin Clark <unk> with Evercore ISI. Your line is open.
Hey, congrats on the progress and thanks for taking my questions just had two.
First of all my <unk>. So after the serene trial was put on hold as you adjusted the BMD monitoring into protocol can you just remind us what changes the FDA wanted.
Juan Camilo.
Gavin there were a couple of things.
You may remember that initially we were running the trial and then otherwise healthy population of women seeking contraception.
After discussion with the FDA, we've changed that population to.
Women with uterine fibroids are in the mid <unk>, which is the target population for that indication in the context.
Of our current and hopefully future label. If endometriosis is approved and then we added the monitoring for BMD that the FDA with requiring.
Those are the major changes.
But we've made to the study design.
Got it and then on the <unk>, we noticed that you changed the specialty pharmacy network last month, which has made the <unk> scripts captured pretty poor so tiffany seems to be consistent but I'm. Just wondering if you can elaborate on the rationale for making that switch.
Absolutely Laura.
Yes, so back in April Cvs acquired U S <unk>, which was one of the two Sps in our network.
And so in order to maintain our distribution model through the independent Sps, we needed to transition our business from U S. <unk> and we switched over to <unk> 360 at the beginning of July the transition has gone very smoothly theres been no disruptions or significant complications and the customer feedback has been tremendously positive.
It is in fact.
They have a lot of experience with <unk> 360.
On other products and in the past so.
We've heard nothing but positive feedback on the transition.
Got it thanks.
Thank you Kevin.
Thank you I will now turn the call back over to Mr. David <unk> for closing remarks.
Thank you operator.
We remain committed to our mission to redefine care for the patients that we serve in women's health and in hormone sensitive cancers, where.
We are well positioned we have two differentiated therapies generating significant growth, we have pipeline opportunities not only now but into the future and we have a strong balance sheet to enable our efforts to deliver sustainable long term value. So thank you very much for joining us I look forward to keeping you updated on our progress have a good day.
Ladies and gentlemen, this concludes <unk> Sciences first fiscal quarter of 2022 earnings Conference call. Thank you for your participation you may now disconnect.
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
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