Q4 2021 Myovant Sciences Ltd Earnings Call
Good day, everyone and welcome to mild and Sciences fourth quarter and fiscal year 2020 earnings Conference call. Today's call is being recorded at this time I would like to turn the call over to Ryan Crowe, Vice President of Investor Relations and miles and please go ahead.
Thank you operator good morning.
And thank you for joining us today for a general business update and to review the financial results of my events fourth quarter of fiscal year 2020.
Joining me for today's call are Dave marriage, and <unk>, Chief Executive Officer, Frank Carbon President and Chief Financial Officer, Lauren Man, Dino Chief Commercial officer and Dr. Juan Camilo on cheap.
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, investor and stop my event Dot com.
During the course of this conference call and there'll 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 and it'll be.
And our control and could cause actual results to differ materially from these statements.
And discussion of these risks can be found on our SEC disclosure documents and it.
And 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 day American My events, Chief Executive Officer, Dave.
Thank you Ryan and good morning, everyone.
Given our 2000 and 'twenty fiscal year ended on March 31st it's worthwhile to briefly reflect on mild and significant accomplishments over the past year.
From a clinical development perspective results from two of our clinical programs were published and the New England Journal of Medicine.
And we announced additional positive data and both uterine fibroids and endometriosis.
From a regulatory perspective, we achieve mild and its first ever FDA approval for or go backs and advanced prostate cancer.
We also filed for U S approval for uterine fibroids and EU approval for advanced prostate cancer.
These impressive accomplishments were achieved while we built our commercial readiness with in house capabilities and through partnerships.
Most notably we entered into a landmark collaboration across oncology and women's health with Pfizer, who has already contributed substantially to the successful launch of <unk> and to our women's health launch readiness.
Now, let's turn to the most recent achievements and upcoming milestones.
In addition to the $21 million of collaboration revenue recorded in the fiscal fourth quarter miles and generated $3.6 million of net product revenue for or globex. During its first three months on the U S market.
And these early days, we have formed the beginnings of a foundation that we believe can support our long term vision.
And to establish a or go VIX and the standard of care androgen deprivation therapy for men with advanced prostate cancer.
We've also made notable progress preparing for our upcoming launch of ROE you go what's combination tablet pending FDA approval.
With only a few weeks before on <unk> date, we are on track for a June launch of this potential new treatment option for women with uterine fibroids.
We and Pfizer are fully aligned on our commercialization approach and are excited about the significant opportunity to improve the lives of women with uterine fibroids and fully unlock the potential of this market.
Last month mild and named Lauren Marin Dino as Chief commercial officer.
Her experience building and leading top performing commercial teams will be critical and delivering our medicines to patients.
I would also like to sincerely. Thank adult goal for serving as our interim chief commercial officer over the past year and.
And for your continued support as a member of mild and board of directors.
On the clinical development front building on the milestones previously mentioned, we reported positive phase III Liberty data from a randomized withdrawal study with first in class maintenance of bone mineral density through two years.
We also dosed the first patient and the phase III Serene study, which is designed to assess the potential a really <unk> combination tablet to prevent pregnancy and make.
Complement our data from the spirit and Liberty programs.
We've also made meaningful progress and advancing towards regulatory approvals we.
We remain on track for an FDA decision by the June 1st Paducah date for <unk> combination tablet and uterine fibroids and or.
And also on track to submit our endometriosis filing to the FDA later this quarter.
And the middle of this calendar year, we expect the European Commission's decision on our uterine fibroids filing in Europe.
Following approval Gedeon Richter, our international partner for women's Health.
As expected to launch <unk> combination tablet and Europe, beginning in the second half of this calendar year.
Lastly on business development, we await pfizer's decision regarding its option for international development and commercialization rights to <unk> and oncology, excluding Canada, and certain Asian countries, which we expect and the middle of this calendar year.
We also continue to evaluate business development opportunities to broaden our pipeline with a focus primarily and women's health and oncology.
Given the rally you go into pivotal studies are largely behind US our proven development engine has capacity to take on and advance drug candidates that have demonstrated the potential for significant differentiation and either preclinical models or and clinical development.
We approach this process from a position of financial strength with $726 million of cash and committed financing.
Fisher runway day, not only fund our product launches, but also to expand our pipeline.
In summary, we are encouraged by the early launch momentum or Bogo VIX.
Finalizing our preparations pending FDA approval to launch and uterine fibroids next month.
We're progressing towards key regulatory milestones, particularly the planned submission of endometriosis to the F D. A.
And are well positioned financially to execute our commercial strategy, while expanding our pipeline.
Now for a more in depth review of our commercial performance I will now turn the call over to our new Chief Commercial Officer, Lauren Marin Dino.
Lauren.
Thank you Dave.
Today I will provide an update on the early progress we've made on on <unk> launch.
And then overview of the upcoming potential U S launch and value Garlic's combination tablet and women with uterine fibroids.
Yeah, and Budick's launches off to a strong start as we embark on redefining care for men with advanced prostate cancer.
Our launches and focused on three priorities educating prescribers and establishing broad access.
And engaging patients.
As we and Pfizer has made progress executing these priorities launch momentum has accelerated.
And only a few short months over 2000 men are benefiting from our buildings.
That's over 2000 men, who has been able to treat their prostate cancer with androgen deprivation therapy without their lives being interrupted by injections without the worry of the testosterone surge and.
With the confidence that if they are able to discontinue therapy their testosterone is likely to return more rapidly.
And our launch quarter, we recorded $3 $6 million of net revenues demonstrating the early confidence physician pad and Oregon.
And it is from this foundation that we expect to build or go back into the standard of care ADT overtime.
Let's take a closer look at the progress we've made on our three priorities starting with educating prescribers.
We increased our growth aided awareness by 30 points since launch 289%.
Nearly as high as branded Leuprolide.
Sure unaided awareness, we quadrupled our prelaunch benchmark, bringing.
Bringing all those extra 20% in April.
This is impressive considering that leuprolide brands are at 39% despite being commercialized for decades.
This is remarkable progress and reflects the effectiveness of our sales efforts and the differentiated profile of <unk>.
Increased prescriber awareness is leading to <unk> adoption and more men and benefiting from this therapy.
And you can see on the Bar chart. The estimated number of men treated with Argos has grown steadily month over much over 2000 and by the end of April.
But we are just beginning to penetrate this very large and growing market.
We expect to build on this early progress and expand our impact and many.
The more of the 300000 men treated with ADT annually.
Clinical and economic and operational factors play a role and ADT treatment decisions.
We have made progress enabling accounts and all three areas.
The depth and breadth of our sales force interactions has grown significantly since launch.
We have conducted over 20000 meaningful interactions with providers, including reaching over two thirds of our highest priority target prescribers.
We anticipate that as COVID-19 restrictions ease and in person detailing resumes and all areas of the country. Our sales force reach and effectiveness will only continue to increase.
Our efforts thus far have resulted in a broad base of prescribers with over 800 treatment centers utilizing our <unk> through April with 75% utilizing more than once.
Yeah.
And we've made great progress and easing the process for prescribing and we.
We have worked with major EMR companies.
To expedite adding <unk> to their systems.
And as a result, all of our highest priority accounts have all available and their E prescribing systems and the majority of our target practices are also enabled for E prescribing.
Increasing prescriber confidence and reducing barriers to prescribing are essential to driving continued uptake.
And as our second launch priority establishing broad access.
As of May 1st we have coverage for our low VIX for 102 million total lives.
On the commercial side, 43% of lives currently have coverage.
Plans that cover approximately half of commercial lives are expected to make coverage decisions and the near term.
Until these coverage decisions are made patients on these plans may obtain reimbursement via the formulary exception process.
On the Medicare part D side, we have achieved coverage for our <unk> for 51% of lives.
And that cover 49% of part D lives are expected to make coverage decisions around mid year with some plans potentially implementing or building coverage beginning as early as July of this year.
We are pleased with the progress we've made with payers thus far.
And coverage as of May 1st is in line with our expectations.
We continue to engage and covers negotiations with key commercial and part D plans with decisions expected in coming months.
Overall, we remain on track to achieve our goal of broad coverage by the end of this calendar year.
Our third priority is engaging patients, which we have primarily done to date through digital channels targeting patients seeking information regarding prostate cancer treatment options.
We developed strong media partnerships with leading health publishers and made strategic investments and search so patients and their caregivers are aware that <unk> is a potential new treatment option for them to discuss with their doctor.
These efforts have successfully driven significant traffic to our branded patient website, where it goes X dot com.
There have now been over 152000 and visitors to the site the vast majority of which were unique.
This is notable because it's four times greater than other oncology launch benchmarks.
As we move into the second half of 2021 we look forward to launching targeted branded and unbranded direct to consumer campaigns to broaden patient and caregiver awareness and to activate men to request or globex at their next visit to the clinic.
So as you can see we've made tremendous progress across all areas of our launch and built great momentum and the prostate cancer community.
As we look forward with increasing physician engagement post COVID-19 potentially.
Potentially expanded access and the second half of the year.
And increasing patient activation through our DTC campaigns.
We believe that the momentum will continue to build and on gold X will make a difference and the lives of many more men battling advanced prostate cancer.
I'd now like to pivot to the potential upcoming U S launch of <unk> combination tablet and women with uterine fibroids.
We expect a decision from FDA by our producer date of June 1st and.
And if approved we anticipate launching later that month.
We believe <unk> combination tablet has the potential to be a truly meaningful advance and women's health and could become the standard of care treatment for women with uterine fibroids.
The unmet need here is significant.
Approximately 5 million women and the U S have sought treatment for symptoms of their uterine fibroids.
These women over 3 million are unable to control their most challenging symptoms due to the inadequacy of current treatment options.
85% of these women and cycled through multiple therapies seeking relief.
And even though two out of three women would prefer a medical option versus surgery, approximately 250000 women a year and the U S make the difficult choice to undergo a hysterectomy for relief from new uterine fibroids.
My event and Pfizer are United in our goal to provide women with and effective well tolerated and convenient medical option that meets their needs and redefine the treatment of uterine fibroids.
When speaking to Obgyn's, they have made it clear that what they need and the uterine fibroid therapy is threefold.
First it needs to effectively reduce the challenging symptoms.
Second it needs to have minimal side effects and.
Finally, it needs to be easy and convenient for them and patients.
If approved we believe that <unk> combination tablet aligns with these treatment needs and is poised to become the standard of care therapy.
<unk> combination tablet formulation combined 40 milligrams and value Garlic's with one milligram of estradiol and half a milligram of progestin.
Our formulation along with the rally you go like half life make our product candidate unique from other gnrh antagonist currently being marketed or those that are in development.
The results of our phase III Liberty studies demonstrated significant relief of heavy menstrual bleeding patients most bothersome symptoms with a safety and tolerability profile that was generally comparable to placebo.
Finally, as 90% of Obgyn's prefer the dosing of <unk> combination tablet is convenient one pill once a day.
Our launch strategy has a comprehensive focus across providers payors and patients with the overarching goal and creating a positive first experience for all customers.
For prescribers.
And will position <unk> combination tablet if approved.
As an effective convenient and non invasive option for patients with symptomatic uterine fibroids.
Our goal with Payors.
To establish broad coverage quickly.
Which we believe is possible given the strong value proposition for <unk> combination tablet relative to other treatments.
For patients, we hope to drive awareness of our product and various channels with the goal of activating women seek treatment for their heavy menstrual bleeding.
The majority of our women's health sales force has been on boarded and preliminary payer discussions are underway.
We expect to have.
Outstanding patient support programs and services available at launch and are confident that we will deliver and and excellent treatment experienced from prescribers and patients from day one.
We have the right strategies in place to accelerate adoption of valuable <unk> combination tablet if approved.
And change the treatment paradigm for women with uterine fibroids.
Our passionate and experienced field team is working to complete final preparations for launch.
We are eager to receive FDA approval execute a differentiated launch and improve the lives of many women who are suffering with uterine fibroids.
I will now turn the call over to Frank to review our financial results.
Thank you Lauren and.
As Dave mentioned in his introductory remarks, my of and fiscal year ends on March 31.
Therefore, the financial results reported today cover both our fourth quarter and full year results for fiscal year 2020.
As usual I will focus my comments on the highlights of our financial performance and refer you to our press release and form 10-K issued earlier today for additional information.
Before we get into the numbers I want to highlight that there are a.
A few new line items on our Q4 financial statements, reflecting on evolution to a commercial enterprise as well as our collaboration with Pfizer.
Let's begin with revenue.
My event recorded $24 6 million of total revenue for the fourth quarter.
And post a $3 6 million of net product revenues from U S sales are from <unk> and $21 million of collaboration revenue relating to the amortization of the upfront payment received from Pfizer.
Collaboration revenue is expected to remain at $21 million in future quarters through the end of calendar year 2026, and the amortization period is scheduled to end.
For the fiscal year, we recorded $59 3 million of total revenue, which in addition to the revenues recorded in fiscal Q4 included $33 3 million of license and milestone revenues, reflecting the partial recognition of upfront and milestone payments from our collaboration with Gilead and Victor.
Well as $1 4 million of collaboration revenue relating to the amortization of the upfront payment from Pfizer.
Cost of product revenue, a new line item for both the quarter and year with zero point $3 million.
And was largely comprised of the high single digit royalty on net sales of our colleagues payable to Takeda as well as expense related to the cost of goods sold from <unk>.
Collaboration expense also and new line items for both the quarter and year was $1 7 million, reflecting pfizer's, 50% share of net profits from sales and for <unk> in the U S. During Q4.
R&D expenses and the quarter with $21 6 million compared to $41 7 million for the comparable prior year period.
For the year R&D expenses were $136 7 million compared to $192 6 million from the prior year.
The decrease in R&D expenses in both periods, primarily reflects the completion and wind down of Mylan and <unk> phase III programs as.
And as well as cost share reimbursements from Pfizer.
Partially offset primarily by increased expenses associated with the build out of my Evans Medical Affairs organization to support the U S launch of COVID-19 and the potential commercial launches of <unk> combination tablet for women's health.
SG&A expenses and the quarter were $78 million compared to $22 4 million for the comparable prior year period.
For the year, SG&A expenses, and $181 4 million compared to $82 3 million for the prior year.
The increase in both periods was primarily due to share based compensation charge of $25 7 million in Q4 related to our change in leadership.
As well as increased spending on commercial activities to support the U S launch from <unk> and.
And commercial readiness activities for the potential U S launches and women's health.
Increased SG&A expense was also driven by higher personnel related costs.
I'm married and the related to the hiring of my average commercial operations marketing and market access teams as well as the oncology sales force.
And higher general overhead expenses to support my of and organizational growth.
My haven't generated a net loss of 81 4 million and the fourth quarter.
And $255 1 million for the year ended March 31 2021 on.
On a per share basis net loss was 89 cents for the quarter and $2 83 for the year.
Now looking ahead we.
We expect R&D expenses for fiscal year, 2021 to be modestly lower and R&D expenses incurred in fiscal year 2020, largely due to our sharing of certain expense with Pfizer.
Overall, we expect declining spent on clinical programs and are winding down to be offset primarily by incremental spend on new relic development programs such as the phase III Serene study to potentially expand the commercial opportunity for the rail economics franchise.
SG&A expense for fiscal year 2021 is expected to continue to increase significantly compared to fiscal year 2020.
This increase is expected to be driven by the full year impact of our oncology sales force, which was on board. It just prior to the approval of a goal VIX and.
As well as the continued buildout of our commercial infrastructure and capabilities to support multiple product launches and commercialization activities, including of course, the hiring of our women's health sales force, which began in fiscal first quarter 2021.
Let me wrap up by commenting on our cash position.
We ended fiscal year 2020, with $684 9 million of cash cash equivalents and marketable securities.
And $41 $3 million of capacity remaining under the low cost loan facility extended to us like Sumitomo Dainippon pharma on a majority shareholder.
Resulting in total cash and committed funding of $726 2 million.
There are several potential milestone payments and coming months.
And further strengthen our liquidity position.
My of and could receive payments of up to 250 million and and Pfizer collaboration alone within.
And within the next 12 months comprised of a $60 million payment with Pfizer decided to exercise the international option for really bullish and oncology.
And as well as to regulatory milestone payments of 100 million each upon FDA approvals for rail and <unk> combination tablet and uterine fibroids and endometriosis.
<unk> is also eligible for milestone payment from Gedeon Richter based upon certain international and regulatory submissions and approvals were rally you always combination tablet and women's health indications.
Mylan has accomplished a lot this past year and.
And we have a lot to look forward to.
Our current cash position.
And significant potential milestone payments over the next year.
Coupled with a sharing of certain expenses with Pfizer.
As well as the anticipated increase in revenues driven by <unk> and the potential launch of <unk> combination tablet.
Puts my event and an excellent position to execute our commercial strategies and at the same time expand on our pipeline through business development.
With that I'll turn the call back to Dave for some closing remarks.
Thank you Frank and Lora.
We are very excited about the momentum we've generated and the first few months of the ore go VIX launch and look forward to helping more men with advanced prostate cancer as we broaden our prescriber education efforts continue to improve access and reimbursement and further engage patients.
We're also making final preparations for a June launch umbrella <unk> combination tablet and uterine fibroids pending FDA approval by the June 1st Paducah date.
Our focus is squarely on the successful execution of these launches and and collaboration with Pfizer to ensure that we're efficiently accelerating our efforts to bring these important therapeutic options to patients.
We also have several other near term regulatory milestones.
We expect the European Commission to make its decision on our uterine fibroids filing by mid calendar year.
We expect to submit our U S regulatory filing for endometriosis later this quarter.
And our European filing for endometriosis will be submitted and the second half of this calendar year.
As Frank highlighted we're approaching commercialization from a position of financial strength, which we expect to continue to build as we potentially achieve additional upcoming milestones.
And our financial position gives us the flexibility to pursue pipeline expanding business development for attractive opportunities and women's health and oncology.
I'm extremely proud of the passion and the work done by our <unk> team to enable us to be and this position to potentially redefine care and positively impact the lives of so many men and women.
And we look forward to what's ahead.
Thank you for your attention and I'll turn it over to Ryan to begin the Q&A session.
Thank you David operator can we now please poll for questions.
Yes.
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 stand by while we compile the Q&A roster.
Our first question comes from the line of Jason Butler from JMP Securities. Your line is now open.
Hi, it's Roy in for Jason Thanks for taking our questions I had a couple on <unk>.
And just where do you guys see the gross to net and in general terms by the end of the year.
And then and centers are with providers.
Any pushback on on our goals.
Are you seeing a greater impact from the payers or is it.
More due to physician hesitancy to try something new or something else and I have a follow up.
Well thanks for the question and thanks for joining US. This morning, I think in terms of the gross to net were not really providing guidance on on the gross to net debt at this time.
In terms of some of the barriers or hurdles that were seeing in the clinics I think as Lorne mentioned, they kind of fall into three buckets, depending on on the practice.
Kind of the clinical.
The financial considerations that they are in office dispensing and then how do they operationalize. It so I think it depending on the practice they can be at different stages as Martin mentioned, we're helping them through each of those stages and we're making great progress.
We are seeing as Lauren mentioned significant uptake from a payer perspective, so while those are initial hurdles to getting patients on therapy.
We've been able to successfully navigate many of those through our hub services and we see that outlook really continuing to improve as we get more payers, making decisions in the coming months.
I've got a follow up okay, great Yeah, and then on the you mentioned and bolstering the pipeline can you just remind us kind of what stage of development candidates and youre looking at and and <unk>.
Target spaces, and they're gonna stay and women's health and mental health are look outside of that thanks.
Thanks.
Yeah, we haven't really ltd, specifically to what stage or clinical development capabilities really have proven themselves over the last few years is really being.
On significantly effective and when we look at therapeutic areas. We are clearly focused on women's health prostate cancer, and then more broadly oncology.
Great. Thank you.
Thank you.
Thank you.
Thank you. Our next comes from the line of Mohit Bansal from Citigroup. Your line is now open.
Great. Thanks for taking my questions maybe.
And maybe.
A few questions if I if I look at the slide number 10, and then the patient trends here. It seems like you're off to a good start with like 700 flow patients added Abbvie mug. So first question is that the numbers. We are showing these ghouls ah patients on net patient and number two it seems like there's a little bit of you know.
From March to April the additional number of patients that probably more than day left before that.
So is it like am I reading too much into it or is it like something that you would expect so.
Thinking about it like more like 512 patients per month is it a fair way of Pingo <unk> about.
And coming year.
Well Mohammed Al and thank you for the question. This morning, I'll, let Lauren and respond to that I think.
One of the considerations when we look at those numbers, we've certainly seen significant growth month to month over the patients that we've started and just recall early on you know the vast majority of patients.
That are coming in and of course, our new starts over time, when we start to look at refills that will supplement.
The trend that we see in terms of our revenue growth. So let me turn it over to Laura and to add a little more color to that.
Yes.
And that's at your.
You're looking at is cumulative patients just to answer your question.
And as you can see we're seeing.
Significant growth and the last two months.
Steady growth throughout but a lot of that is due to us as Dave mentioned earlier, removing some of those hurdles.
Due to utilizing our products so working with them.
Getting <unk> and the E prescribing systems and ensuring that our customers.
<unk> had the information they need to set up in office dispensing and then of course, making sure that physicians understand our clinical profile. So do all of that I think that that is driving the more recent acceleration that youre seeing in that growth.
Very helpful.
And welcome to light relative and Saudi I didn't say that before.
Congrats on the new gig.
One other question.
And then just positive patients you had.
On a matching and the U S are these all new patients who started <unk>. These are like.
These are like some from beef costs are also included in debt.
Yes, I'll, let Lauren take that in terms of the types of patients that we're seeing initiating therapy Lauren.
Yes.
And so.
Total being maintained.
And then as far as.
What we're seeing.
Sure.
Is.
It's early days and we have limited information based on our distribution model.
On.
Since the majority of patients are receiving treatment through in office dispensing.
And the claims data is still immature at this point.
But we are seeing a broad range of patients.
Initiating or growth ex therapy, including both naive as well as those transitioning from other ADT therapy, but we'll have more information as we get as the.
The data mature.
Awesome. Thank you very much law and really appreciate it.
Thank you.
Thank you. Our next question comes from the line of Eric Joseph from Jpmorgan. Your line is now open.
Hi, good morning, and thanks for taking my questions.
On our go VIX and the OCA.
And just wondering what youre seeing in terms of repeat.
Or refill rates and also <unk>.
Fiber right.
In terms of payer coverage or to what extent are you seeing payers require step edits through.
Wired Lupron and other key growth products.
And is there a meaningful difference between.
Commercial payers versus part D.
And then just looking to the launch of relative <unk> combination tablet.
Where do you see day in terms of product or brand and awareness and.
And what our providers expense.
Or what are your expectations among providers in terms of how they're on.
Great RCT into there.
Good practice.
For taking the question.
Well, thank you Erica, let's see if we can.
Ed.
And go through a few of those questions on.
I'll let.
Laura and talk about the awareness numbers that we're seeing and just a moment I think when we look at the your question regarding what we're seeing in terms of step edits and commercial versus part D recall that our commercial coverages.
And as we would expect this pacing a little ahead of part D. We expect part D decisions to be coming through the second half of the year and really be and full force as we get to.
Flipping into January of 2022, but we're very comfortable with the progress that we've made in terms of commercial coverage overall and and what we are seeing is.
Coverage that is consistent with our package and search so it does not require a step through another therapy prior to initiating our therapy and that's.
And Thats, how the payers are looking at this so Loren do you want to take the awareness numbers yes.
Sure and thank you for the question.
So we're quite proud of our awareness at this point, though.
<unk> launch, we have seen a significant increase and increases our 30 points and our aided awareness.
Bringing our awareness to 89%.
And then for unaided worried about 20%.
In April and that.
And compares well when we look at branded Leuprolide, which is at about 39%.
And although it's been on the market for decades so.
So we believe this demonstrates the effects of our marketing and sales efforts to date.
But where we're never satisfied and we will continue.
Two.
To spread awareness and the cash.
On the month.
And.
Sorry about that thanks for that Lord and sort of clarify day event.
A combination Doug.
<unk> combination tablet awareness for uterine fibroids.
And just sort of where.
Awareness is I presume your comments related to prostate cancer.
Where does it were to stay on.
Okay.
Alright, I thought you were still asking about <unk>.
Hi.
And I don't have the numbers in front of me for Valley.
<unk> combination tablet.
Awareness.
But we can certainly circle.
Good luck with you and provide them.
Okay and.
On.
On refill and repo rates can you comment on how those Italy.
Thus far I know, it's early days, but presumably you'd have maybe one or two months years and looked at conversion from new starts.
And results for the balance on most of them.
Yeah as a reminder, Eric given the distribution network, we don't get the patient level data with the vast majority of our distribution channel going through specialty distributors and in office dispensing. So we don't always capture.
What the the nature of the prescription if it's for a new patient or a.
Or if it's being rebuilt so we don't have a specific number in terms of the specific proportionality between our new Rx and a refill Rx.
Okay got it alright.
Alright, great. Thanks for taking the question.
Yes, Thank you Eric.
Thank you. Our next question comes from the line of Paul Choi from Goldman Sachs. Your line is now open.
Hi, Thank you and good morning team and congrats on all the progress.
Wanted to follow up on Eric's prior question, particularly with regard to the commercial side and can you maybe just comment on where in terms of cheering org.
<unk> has fallen and so far on on the commercial side for the most part and I recognize it's early days.
So going on do you want to talk about the commercial coverage.
Yeah. So so you're right. It is early days however, we are.
Excited with the progress we've made so far.
And as I as I mentioned, we have.
43% of commercial patients currently have coverage.
And we're also seeing about 51% of the part D.
And patients having coverage.
As far as hearing we are generally.
Being covered and alignment with RPI.
And and and are satisfied with the coverage that we've seen to date.
I think where we have coverage not only have we been able to.
On to secure.
Adequate coverage, but also I think one of the areas that we've been very pleased with is the.
And.
Kind of the pre PMT Committee review coverage, where we have.
And when patients go through our hub services.
We're able to achieve coverage for <unk>.
And two thirds of those patients already so either with the payer coverage itself or with the pre approval or pre authorization of that so we're very pleased with where we are in terms of the initial coverage that we're seeing and again per pie. So there are no requirements for step throughs. We also have the co pay assistance programs for <unk>.
<unk>, who are commercially insured as well and we're seeing patients take advantage of that program.
Okay. Thank you. Thank you for that additional color.
And then as a follow up I was wondering can you maybe just sort of characterize what sort of media and our typical patient who is on therapy now and is this business tend to be a de novo patients or patients, perhaps with with cardiac risk issues.
You highlighted that and your prior data and it's.
And the label as well so is there any sort of preference are sort of on average patient type that you can characterize so far.
Yes.
I'll, let Laura and add some color to this but I think.
Again in the absence of the patient specific data, we're relying much on.
And what we're hearing from the field and what physicians are telling us and and certainly it crosses the board you can imagine that many patients.
Net are naive to therapy are at that cusp of making a treatment decision and so those patients are already.
Making a determination of therapy, so we skew probably a little more to some of those naive patients simply because they're at a different point and you know on.
On the initial point of their treatment journey.
We are hearing a significant amount of transitioning of existing patients and that's for a variety of reasons as you can imagine they're the oral versus injectable profile is something that's highly desirable for some physicians and some patients and.
And then with the increasing risk of or focus on cardiovascular risk. We know that that is one of the areas that positions are significantly.
Aware of and that certainly has been one of the motivating factors for some of the patients that we're hearing coming from.
Discussions with physicians and so that's how I would characterize it and again, it's difficult to kind of put on average patient out there.
But we're seeing that across the board, probably leaning a little more and to naive patients and we are and patients transitioning at this point Lauren is there anything else you'd like to add.
No I think you covered it.
And as as the claims data matures and we hope to have.
More insight, but right now we're limited to what the field can tell us.
Okay. Thanks, Dave Thanks, Lauren and for taking our questions.
Sure. Thank you.
Thank you. Our next question comes from the line of Phil Nadeau from Cowen. Your line is now open.
Good morning, let me add my congratulations on the progress.
First question on the $3 $6 million and revenue how much of that was and user demand versus <unk>.
Channel fill.
And I'll, let Frank Reeves.
Review the.
And of the revenues.
Phil.
Thanks for your question. So remember we report revenue at the point of sale to our specialty distributors or specialty pharmacies.
So the net revenue that we reported a $3 6 million is.
This revenue associated with with products sold to those distribution channels.
We have not seen any unusual ordering patterns throughout the quarter or towards the end of the quarter that would suggest that there was any channel stuffing going on.
Do you have a sense of how much inventory.
And the channel is it the typical two to three weeks.
Yeah, we wouldn't we don't have any reason to believe that it is more than that and once we had the initial.
Stocking that we saw in January we've seen the levels can gradually and continuously increase but there is no reason for us to believe that it would be anything other than than what would be the normal inventory channel part of the reason why we don't have as much visibility as we don't know.
What has moved from our specialty distributors that might be and in office dispensing pharmacy, we would expect that to be low, but we have no visibility into what might be sitting on the shelves. There we wouldn't expect it to be significant but thats why we have a little less visibility into that but we're not seeing as Frank mentioned.
Any unusual buying patterns and no reason to expect it to be any different than as you mentioned and the order of three weeks and I.
Ken and Phil what we are seeing a regular reorders from our.
Distribution channels, so there's sort of a regular pattern and that has set in and what we are observing is.
And that ordering reordering on a regular cadence, but the overall numbers of course are going up in line with increase in demand.
It's very helpful.
And a follow up to Paul's question in terms of the patients who are using therapy have you seen any trend I. Appreciate it's very early days.
Have you seen any trend towards more intermittent dosing.
And now that there are some short acting oral option available and so that's something that physicians have indicated to you or.
Any signs of it or is it simply too early and the launch today.
Well I think.
We're certainly getting patients of all.
<unk>.
And what kind of therapeutic intent.
And so we are hearing from the field that physicians are trying it across a different a range of patients.
And so that would certainly be and the mix, but I think the bulk of it would be other patients that are starting therapy as naive and maintaining continuity of therapy or switching from other therapies and again, maintaining consistency that would be the vast majority of what we're hearing from the field.
Got it Okay and then last question from US is on the upcoming uterine fibroids and launch it seems like the launch.
From Abbvie is going slower than we and I think even abbvie expected what have you guys learned from their commercialization efforts and and.
Theres stumbles and uterine fibroids debt of better prepared you too to launch.
And to that market.
Yes, I think there are a few things.
First and foremost I think it's really understanding the marketplace and we've done a.
Fair amount of research as I'm sure you can imagine and understanding what is it the market is looking for and earlier Lauren referenced that the three things that were hearing consistently from particularly gynecologists, who are the vast majority of the prescriber audience here.
And what Theyre looking for our therapies that first and foremost take care of the symptoms.
Therapies that are have a tolerability and safety profile that they are attracted to and then third specific for this therapeutic area and this audience the idea of.
Convenience straightforward dosing.
He was a little higher for this therapeutic area and and many others that I work force. So that's really important not only for the prescriber and what theyre looking for but what they believe their patients are looking for so when you look at.
Our clinical data and how we align to those needs of the marketplace is telling us we believe that we're really well positioned to really address those priorities that that physicians are telling us, particularly when you look at.
Some of our Tolerability data, whether that's hot flash and other areas.
Certainly BMD as an area of focus for clinicians and then finally, the simplicity of dosing what physicians tell us is they overwhelmingly prefer a once daily therapy.
And certainly is much more in line with what this audience is accustomed to so from a clinical profile that is one of the things that we think just getting out of the blocks.
And that our clinical data really aligns well with the the market unmet need and then the other point that relates to simplicity and convenience is how you support both the practices and the patients with patient support services and.
Reimbursement support services, we fully expect that we will have those services are very robust suite of offerings available at the time of launch and we believe that our first experience with.
With <unk> combination tablet once approved we think is going to be a very positive experience for clinicians and patients and we think that's going to be something that's really going to help us and the early days.
That's very helpful. Thanks for your perspective.
Sure.
Thank you. Our next question comes from the line of Brian <unk> from Baird. Your line is now from.
Hey, good morning, everyone and thanks for taking my question.
I have a question on also on on sort of the patient numbers by month Slide Slide 10.
And just kind of back calculating it would seem something that you guys have something on the order of maybe 2700 <unk> by the end of the.
Our quarter ending in March can you just help us understand sort of the free versus commercial dynamic here I mean, it would seem with that number of TR axes on on a fully commercial basis would be like a five 4 million and demand sales.
So you know.
The quarter composed about half and half of free versus commercial.
And and how do we kind of think about those three patients on and do they get converted to commercial and and how do they sort of flow through to that thank you.
Yes, well thank you.
For the question Brian.
And having the free goods program in place to help physicians kind of get off on the right start with patients to fulfill their treatment desire has really been beneficial.
And the early days, we certainly have seen a number of physicians and patients take advantage of the free goods program, but also because of the the coverage we've been able to achieve early and the success that our hub has had in terms of seeking.
<unk> coverage, then we haven't had to lean into that quite as much as we might have thought initially so we're still seeing significant patient volumes coming through our hub.
Again about two out of three of those patients who are seeking coverage, we're able to achieve coverage we lose sight of them. Once we have helped to secure that coverage to know what happens once they go back to the office, we don't have the tie off to understand what happens once the once we've achieved that coverage. So I can't give you.
Quick numbers, there, but I think overall, if you were to look at our volume as it relates to free goods.
Looking at about a third.
Overall as what we've been seeing and of course that has.
Migrated somewhat over time as more and more coverage comes on line.
Okay. Thanks, that's helpful.
Great.
Thank you Brian.
Thank you at this time on Im showing no further questions I would like to turn the call back over to Dave Merrick for closing remarks.
Well. Thank you everyone and as you can see <unk> is off to a very exciting time.
With our evolution from a clinical stage company to now a clinical and commercial stage company.
Clearly, we're well positioned both operationally and financially to really deliver strong commercial execution and build sustainable long term value.
So thank you for joining us today and I look forward to keeping you updated on our progress.
Ladies and gentlemen, this concludes miles and sciences fourth quarter of fiscal year 2020 earnings Conference call. Thank you for participation you may now disconnect.
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