Q4 2020 Chiasma Inc Earnings Call
Good afternoon, ladies and gentlemen, and welcome to key asthma as the fourth quarter 2020 conference call.
At this time all participants are in a listen only mode.
A question and answer session will follow the formal presentation.
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Please note that today's conference is being recorded.
At this time I'll turn the other let's say to introduce Glenn garment of Investor Relations. Please go ahead.
Thank you operator, welcome to the key asthma fourth quarter and full year 2020 earnings conference call earlier today, we issued our fourth quarter 2020, and full year operating and financial results via press release, a copy of which may be found on our website. During this call we will be making certain forward looking statements about events and circumstances.
Including but not limited to statements concerning our expectations for the ongoing U S commercialization of the caps of including its potential market adoption and commercial success the size and composition of the U S market from a cap so the commercial and therapeutic potential of my capture and anticipated and market acceptance and ensure.
<unk> coverage of and access to my Capstone, and our ability to convert endocrinologists and patients to my cap stuff from Octreotide or Landry of tide injections are commercial organization strategy and efforts and potential sales and revenue growth our expectations regarding financial results and the timing of our planned and the caps of E.
The marketing application and whether the empower data will support marketing approval and the EU the.
These statements are based on current expectations and information available to US you should not place undue reliance on these statements we may not achieve our goals carry out of our plans or intentions or meet expectations.
Actual results may or events may differ materially due to the numerous risks and uncertainties, including those detailed in the risk factors section of our form 10-K filed with the SEC for the year ended December 31, 2020, as well as our subsequent filings with the SEC. We encourage everyone to read these documents except as required by law.
<unk> disclaims any obligation to update information contained in these forward looking statements whether as the result of new information future events or otherwise joining the call today is Raj Kannan, Chief Executive officer of non Barrett on executive Vice President and Chief Commercial Officer of Bill Ludlam, Senior Vice President of clinical development and medical Affairs and <unk>.
John Doyle Senior Vice President and Chief Financial Officer at this point I'd like to turn the call over to the asthma, Chief Executive Officer Raj Kannan Raj and thank you Glenn and thank you to everyone for joining this call today.
I'll start my comments with a brief update on our my capsule of U S phased launch.
And plans for all of my caps, the EU marketing application submission later this year and.
Don will provide additional color on our launch progress and our learnings to date and then John Doyle, Our Chief Financial Officer will review, our fourth quarter and full year financial highlights.
I will wrap up with closing comments before we turn to your questions for which Bill Ludlam will also be available.
Let me start by providing an update on our my caps of States U S launch progress.
We continue to gain traction with U S physicians patients and payers.
Last quarter.
I said that I anticipated that we would and the year with 100 million covered lives.
We did much better than this.
We reported and our January update and today's press release.
We secured payer coverage of my caps or where.
Over 150 million lives in 'twenty, and 'twenty, which we believe reflects my caps a strong value proposition.
And for White for a good foundation for growth in 2021.
We were also encouraged with the positive feedback from physicians and patients on the product profile and on their desire for a less burden from treatment option for acromegaly.
Our label allows us to promote my capsule to an estimated 99% of U S acromegaly patients on SSA Injectables.
We continue to believe that might cap the has the potential to become the new standard of pharmacological care for patients living with acromegaly.
The COVID-19 pandemic continues to impact our ability to conduct many of the education and outreach activities that would be part of the traditional drug launch.
Many patients are delaying physician office visits and many physicians simply cannot be seen in person by our field sales team as the result of office closures travel and other restrictions and and.
Dissipation of this challenging environment.
We adapted our launch strategy in two ways, which we have discussed previously.
We chose a phased approach to the build out of our commercial team.
Second we continue to leverage the digital and virtual capabilities at our disposal to educate both the endocrinologist.
And their acromegaly patients on the many benefits of my cap growth.
With positive early feedback from prescribers.
Patients and payers do you and parts of our efforts to increase awareness of my cap. So we believe that as a more normalized business environment returns, allowing inputs and sales calls.
We are well positioned to drive continued growth for my capsule.
Shifting to our phase III and powered study.
We're excited.
The announced positive top line results in November.
We're in the process of preparing a marketing authorization application of the plan for submission to the European Medicines agency and mid year.
Recall that empowered compared the my tax of efficacy safety symptoms and quality of life scores the door.
It was the patients treated with Octreotide L. A R or landry of tide depot of Injectables.
And further expanded the overall clinical dataset for my capsule.
In addition to supporting potential marketing approval in the EU the.
And the positive results from empowered add to the body of clinical evidence demonstrating my cap the safety and efficacy.
We plan to submit these data for publication and a peer reviewed medical journal later this year.
We're excited to announce that we've had six abstracts accepted for presentation at Endo 2021, which is being held March 20th to the 23rd.
Five of the abstracts, all late breakers have been accepted for poster presentation and will highlight the empower data the.
The six will be an oral presentation on the long term one year efficacy and safety data from the open label extension of our key asthma optimal phase III trial.
Recall that 90% of subjects, who received my caps of during the randomized placebo controlled portion of this trial voluntarily elected to continue into the open label extension.
Lastly.
Let me make a brief comment on our balance sheet.
We believe we're adequately capitalized to fund our ongoing U S commercial launch.
Excluding restricted cash we.
<unk> ended the year with approximately $135 million of cash cash equivalents and marketable securities.
As we indicated last quarter, but bears repeating we believe our spending increases over the course of 2020 have been responsible and measured.
<unk> and connection with our phased commercial launch of my Capstone.
At this point I'll turn the call over to and none for an update on our launch progress.
And on.
Thanks Raj.
Last quarter, I detailed the phased manner, and which we intended to deploy our commercial resources to support the launch while also taking into account. The COVID-19 related headwinds that we continue to see across the selling prescribing and patient fulfillment processes.
Beginning late in the third quarter, we commenced phase one with a focused sales team of 10 professionals, calling on approximately one third of what we identified as key accounts as Raj mentioned, we deploy technologies to enable remote engagement with customers and complemented these with enhanced digital.
Media to reach and educate hcp's and patients.
We believe the encouraging feedback from the early interactions with Hcp's and patients confirms the unmet need for an oral S. S. A option for patients and the appeal of my capsules label and clinical profile.
Additionally, we believe this early experience sheds light on the challenges of COVID-19 presents at this point and time and confirms our decision to take a phased approach to the launch.
We decided to progress to the second phase of our launch at the beginning of this year with the addition of another 12 sales professionals, who are hired and trained during the fourth quarter of 2020 in order to expand the target audience, we could reach as well as provide more intensive support to hcp's and patients for.
And the time being we feel the organization is right sized to reach and support key target customers that will drive the initial launch trajectory.
Still accounting for the current environment, we plan to evaluate further expansion of our commercial team as market conditions warrant.
Critical to our successful launches ensuring the acromegaly patients who can benefit from my cancer are able to obtain the insurance coverage.
Of continued to make significant progress with market access for patients and exceeded our goal of 100 million covered lives by the end of 2020 by entering 2021 with over 150 million covered lives.
We continue to build on our success to date and are focused on expanding the breadth of coverage to obtain access for more patients and also increase the speed and efficiency of converting prescriptions into commercial shipments.
And because of the U S. Acromegaly market is concentrated with 90% of patients currently on injectable SSA is estimated to be treated of fewer than 1000 medical practices, we're able to deploy and efficient and targeted commercial team.
Our commercial efforts are focused on physicians and major pituitary treatment centers or ptc's.
The regional referral centers and the limited number of community endocrinologists.
And we've continued to put an emphasis on clinicians operating and Ptc's. We both see the highest concentration of patients and are influential on the treatment practices of their colleagues.
Despite the fact that the academic centers and which most ptc's operate we're impacted by pandemic related restrictions to access through the end of 2020, we've reached nearly 90% of ptc's with either of face to face of remote personal sales call our digital contact.
Amongst the larger group of higher priority non PTC accounts, we've reached nearly one half of them with either of personal sales calls or digital contacts with the initial phase of our sales sales team.
We expect to continue to expand our reach with the deployment of the second phase.
Of the beginning of this year.
Also as previously mentioned, we have upgraded our digital capabilities and tactics the complement our personal selling efforts.
Traffic to both our HCP and patient websites has exceeded our expectations and the engagement of visitors to the site as indicated by the time they spend the content the interact with and the materials they download and test the importance of the source of information during the pandemic.
Although we've made steady progress and reaching customers with the initial phase of our commercial initiatives and have been successful in obtaining insurance coverage for patients. We believe the processes for both prescribing and conversion of prescriptions in the commercial shipments have been impacted by the reduction and patient visits the HCP.
<unk> limitations on access of sales personnel of the clinical offices, and the reduced and remote staffing of HCP offices.
Importantly, we contrast, this near term effect of the pandemic to our continued conviction and the longer term prospects of my cancer, which we continue to believe will become the standard of pharmacological care for the maintenance treatment of acromegaly.
The initial uptake of my cancer and the late third and early fourth quarters of 2020 was driven by patients Hcp's identified as highest priority for an oral S. S. A and also the conversion of patients enrolled and the open label extension phase of our phase III studies.
More recently, our new prescriptions have been entirely from non clinical trial conversions as clinicians continue to identify and prescribe for a broader group of eligible patients.
The source of prescriptions was more heavily represented by community based endocrinologist earlier and the launch and they tended to operate and practices, which were more open to our promotional efforts.
Due to the diligent efforts of our sales team, we've begun to penetrate ptc's two of greater extent and there.
<unk> been and increasing source of new prescriptions.
With the expanded second phase of our selling efforts were focused on driving greater depth of prescribing among hcp's, who have already initiated and have experience with patients on my cancer.
That's the prescribing will be especially important among ptc's and the highest volume accounts as they tend to have multiple SSA patients eligible for conversion to my cats.
The conversion of prescriptions into commercial shipments was similarly impacted and the near term by the inaccessibility of Hcp's needing to complete prior authorization documentation for payers, it's and.
Important to note that the nature of the prior authorizations and the documentation needed and have been generally in line with our expectations.
But the timeframe HCP is of required to complete documentation is longer than would be expected and a non COVID-19 environment.
We believe that the significantly expanded payer coverage, we have achieved will be helpful and increasing the speed and efficiency of convergent and the commercial shipments until office staffing returns to more normal patterns.
Overall, although the timing is difficult to predict since many of the COVID-19 related restrictions, which intensified in the fourth quarter of 2020 are currently still in effect.
We believe that the fundamentals are in place to further strengthen the launch trajectory and the environment becomes more favorable.
Now, let me turn the call over to John for a review of our financial results.
Thank you and not <unk>.
Revenue for the three months ended December 31, 2020, and was $1 million revenue for the full year 2020 was $1 1 million at the upper end of the range that we provided and of January six 2021 business update.
Selling general and administrative expenses were $13 6 million for the fourth quarter ended December 31 2020 as.
And as compared with $5 9 million from the same period of 2019.
Selling general administrative expenses of $44 9 million for the full year, 2020 as compared with $15 1 million for the full year 2019.
The increase of $7 7 million and $29 8 million for the three and 12 months ended December 31, 2020 include our pre commercial and post approval sales and marketing activities and increase and personnel related expense and other administrative costs to support the commercialization of my cap the and the U S.
Research and development expenses were $4 5 million for the fourth quarter ended December 31, 2020, compared with $6 4 million for the same period of 2019.
Research and development expenses were $26 8 million for the full year, 2020 as compared with $22 5 million for the full year 2019.
The increase and current year period results were primarily driven by the preapproval manufacturing of Octreotide capsules to support our U S. Commercial launch costs associated with our macro disease state registry and increased regulatory costs, which were offset by a decrease and clinical trial costs.
Manufacturing costs related to the production of commercial suppliers of my cats. The following FDA approval are now capitalized to inventory and no longer recorded and R&D expense.
For the quarter ended December 31, 2020, net loss was $19 8 million or <unk> 32 per basic share.
Paired with the net loss of $12 million or 29 cents per basic share for the same period of 2019.
For the full year 2020, net loss of $74 8 million or $1 43 per basic share compared with the net loss of $36 3 million or $1 six per basic share for the full year 2019.
We ended the fourth quarter with approximately $135 4 million of cash cash equivalents and marketable securities excluding $20 6 million of restricted cash.
And with $92 4 million as of December 31, 2019.
We believe our cash balance of sufficient to fund our operations as currently planned through at least the next 12 months, including the continued execution of our U S. My caps the commercial launch.
Looking ahead as we outlined in our business update of January six we anticipate full year 2021 operating expenses to be in the range of $80 million to $90 million.
Including estimated stock based compensation expense and a range of 5 million to $6 million.
This guidance is based on our current U S commercial plans and exclude the expenditure from potential EU launch preparations of my contract and potential additional new product development programs.
As it pertains to first quarter 2021 revenue, we anticipate modest sequential growth relative to the fourth quarter of 2020.
For the full year, 2020, one and we're confident and the commercial team that we've assembled and the infrastructure that we put into place and believe it will support the launch trajectory of the pandemic subsides and a more normalized business environment prevails.
Now I will turn it over to rush rush.
Thank you John.
Let me wrap up by saying.
I'm excited about our momentum at key asthma, and having met all of our key milestones in 2020. Despite COVID-19.
We believe we have built a strong foundation as we enter 2021.
And we anticipate a continued strengthening of our U S launch trajectory to take shape as the business environment reopened.
We look forward to submitting our application for marketing approval for my caps of in the EU.
And if approved would allow us to expand the benefits of my cap. So the patients outside the U S.
We will now open the call and take the questions.
Thank you at this time, we'll be conducting a question and answer session.
And to ask a question. Please press star one from your telephone keypad and the confirmation tone will indicate your line is and the question queue.
You May press star two if he would like to move to your question from the queue.
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One moment, please while we poll for questions.
Thank you and our first question is from the line of Chris Howerton with Jefferies. Please proceed with your question.
Great. Thanks, everybody for taking the questions and congratulations on the progress.
So if you few questions from me with respect I think maybe we could start with the obviously the commercial launch.
Very important piece of the story right now so for one of the things are non debt you mentioned was.
On the receptivity of your marketing efforts.
In the context of the different centers community versus the pituitary treatment centers and so I guess, you know I I would be and I would like to better understand the strategy as it relates to kind of you know.
Let's say the available Tam that you have right now in terms of accessible centers that might be.
And you know reachable via virtual efforts versus those that are in person and I guess the follow up to that is that like what is it about in person visits that make it so much more impactful for the pituitary treatment centers.
And so that that's one question and.
Other question that I have is around him if youre seeing any refill rates yet.
And if so what what have those been a third is what if any expectations you are able to provide around coverage.
During 2021.
And maybe I'll stop there and just see if I'll hop back in the queue after that.
Yes, So hey, Chris this is Raj.
Just give us maybe a couple of the overall.
The overarching statements and then let.
And on and.
Addressed some of that and more granularity thanks for your questions.
I think in general and the in person visits and the virtual visit within the PTC theres not much of the difference in terms of quality or of the call itself and and educating on hcp's within Ptc's I think where the in person does become important is facilitating.
The paperwork that sometimes it's necessary in the rare disease area like ours, where we will have to get the benefits investigation done.
Get the quick start program authorized with the patient and so it requires a little bit of coordination within those offices and given COVID-19, we faced some challenges early on with the office dynamics, breaking down where that facilitation with nurses being remote and position as being the most has.
It's been quite difficult.
I think on the refund rates its a little bit too early to comment on that but you know all.
All I can say Christmas there's nothing that has been surprising in terms of a fallout. So I think the comment that we made in the prepared remarks, which is that we're pleased with the reception that we're getting with patients and physicians continues to hold and I think the last one in terms of 2021 coverage, we are certainly and making good.
Progress with payers and we hope to continue that coverage.
And and that progress in 2020, one and we believe that buying itself will also facilitate the easing of some of that paperwork that we had to do early on when there were no formal policies put in place.
And on did you want to add anything to what I just responded.
Yeah, Thanks, Raj and the also Chris for the the question. So let me think of.
Yes, let me answering the question regarding the strategy that we employed entering the marketplace and so we obviously had the opportunity and the months before launch to be able to prepare for the asbestos we could for this COVID-19 environment and restrictions to access and the like.
But strategically we did tier our accounts. So we've put the the pituitary treatment centers at the top is the the top priority accounts and.
And because of both they have the concentration of patients and and they also have influence to a broader body of endocrinologists that of that also have acromegaly patients and then also then we kept the toured.
And the community based customers based upon the volumes that we understood that they said that they were to have I think the adaptation that we needed to make to the strategy. Chris was it. Although you want to go where the business is and right at the top of the Ptc's they tended to be the ones that had the most restrictions to access.
Especially early on and then throughout the fourth quarter it relax for a little bit and the end of Q3, and then tightened up again in terms of access restrictions and Q4. So what we what we did of continue to persist with those accounts until we can continue to penetrate the more fully but we then expanded our focus to that a bit of a broader base because we.
Wanted to get the momentum going in terms of the prescribing of the product and then as the access well was able to be gained within the PTC setting and we said like through the end of the year or we've got and to almost 90% of them. At this point that we started to see more prescriptions coming from the top of the pyramid. If you will from that but two of trade treatment Center.
And that's going to be important for our ongoing momentum as we as we head into this year, so strategically we'd be needed to be adaptive both with the the kinds of calls, we make and and where we targeted and focused on them and then.
The thing that I would add to what Raj said about the face to face versus remote is exactly right that the quality of the call that you can deliver remotely.
It's certainly going to be of high one and four and factor in some instances you get longer period of time with those customers in order to be able to deliver of full sales call, where you don't get the full opportunity face to face, but what you do get when you have face to face of access and we found is to be able to move the call continuum along faster from one.
And your first introduce my cap to them understanding the patient types of its appropriate for the wanting to prescribe the product identifying and bringing that patient and so they can actually put the prescription into place and then once the prescriptions. There. The help that we can help to facilitate and terms of their ability to do the prior authorizations and the like and to work with.
Their office staff in order to be to facilitate them all of that is much easier when you're interacting face to face and that you can be in there that you can drop in and then to move that process along if it's all scheduled remote calls and those are occurring and.
More infrequent are infrequent times, then that's going to slow down the process and that's the the essential distinction that we're seeing between face to face Andrew.
And remote on that front, so I think that on refill rates and coverage of rise captured most of it. If you had the further detail you wanted on that I can.
And try to help you with the with that as well.
No no. That's that's really helpful and I guess, you know maybe as a follow up to that it's.
It's striking to me that.
It sounds like the at the in person visits are very impactful to convert the physician to prescribing physician and that maybe you know other types of visits or touch points.
And I would be okay as long as they've already been converted is that kind of a fair read on what you're seeing out of things.
Yeah, I think that well first of all the the room.
Note calls the video and the video conference calls zoom or whatever.
Came a little later in the in the and the launch timing right. So you're spending time before launch trying and get those lined up but they get scheduled when the office permits those to be scheduled and sometimes those didn't occur right away and if you can actually get into a customer where the face to face call and we saw this very early and the launch phase you can just get the process moving but then your.
Exactly right that when you do have a face to face discussion and you're able to and even it doesn't matter if you've converted them fully you've initiated the process you've started to talk about it then you can set up those future remote engagements, whether it's through zoom and the phone call email in order to them and continue to propel that process through but the.
There is really where we've done a lot to move to remote but in some instances, there's just no substitute for having that sort of face to face interaction and we've seen that in some instances and that's how the and it certainly had an effect in these early days.
Okay.
And I you know I said I was done, but maybe one of our of course and if I may be.
You know for what about specific metrics in terms of.
The launch strength or launch health and in terms of patients on drug number of prescribing physicians do you have any plans to provide any of that kind of information.
So yes, we do have plenty of Oh go ahead of pro had on them.
No I would guess it we do have plans to provide that information, Chris we want to do it at a time when we think it's most informative around the actual trajectory of the launch and some of the early the early factors of where we are right now and the and that in that trajectory I think would not provide the clarity of that I think you and your colleague.
And everybody else would want and about how things are going so as soon as we have a sense of those kinds of metrics would really be informative in terms of the the true trajectory of the launch and then also things that we're seeing better hopefully are changing and a positive direction as the environment becomes more favorable I think we would definitely want to be sharing those those metrics too.
Yeah.
Okay, all right well fair enough well. Thank you very much for indulge and my question. Thank you.
Thank you thanks of interest.
And of course.
The next question is from the line of Ted and health.
Piper Sandler. Please proceed with your questions.
Great Good evening, everybody and thanks for the uptake congratulations on the progress I wanted to get a sense for how closely you're monitoring scripts and sort of how that data is coming to real time.
Hi, Ted this is Raj.
Thanks for your question.
Because we have of specialty pharmacy.
And and we have a.
Our patient support program, where patients do often.
We have a very close monitoring.
Monitoring so to speak of where the prescriptions are coming from who the patients are obviously with the firewall on Mississippi.
Compliant from an organizational standpoint, we do not know the patient's names of any details, but we do have a very good sense from where those prescriptions are coming from.
Beyond that and I did.
Did you want to add something.
No I mean, but just Ted.
And you follow it extremely closely so that's clearly there is no metric that's more relevant to our progress the the distribution system and Raj described allows us to have.
Instantaneous understanding.
Where that is and so that that helps a lot in terms of being able to track that and put the emphasis and focus where we need to tweak and continue to drive that trajectory.
That makes a lot of expense and then just with respect of pricing and so probably a little bit early but I think you guys quoted like a 5152 price for 40, Meg 28 day supply.
Or is that looking just with respect to the sort of weighted average in terms of what people are using it and maybe any gross to net discounts.
Trying to get a sense on how pricing is sort of starting the hold off and the real world. Thanks.
So and I'll, let me tickets a crack at this and then you can add a commentary if I've missed something so a great question I think in terms of price you know we're at $5384 for a 40 milligram per day 28 day supply.
That being said remember we had said we had set the price and a way that predominantly becomes out of placement for payers and and that's what you see which is a significant progress being made with payers today from from the price value equation.
And I'll, let and on our way.
Way and more with details on the other part of your question and on.
Yes, Thanks Raj so Ted the in terms of the the.
The weighting of the the doses, we're still seeing more of the patient is the since a lot of these patients are and that initial phase.
Sales of being introduced on to my caps of there being started predominantly on the 40 milligram dose and so then as the as titration is necessary then we would start to see those move up.
As we did and are in a clinical trial settings, but at this juncture of the so the fact that the patients came in at the <unk> 40 for the most part.
That would mean, the that's where the the the tilt is in terms of our and.
Our dose spread at this at this point and we'll see how that goes the one one exception of that are the some of the patients have converted obviously from the open label extension phase of the Phase III study. So we saw that earlier on and some of those patients had already titrated to a higher dose and they would have converted to commercial Mike.
Caps at those higher doses as well.
The the other part of the question Ted what's the gross to net.
And you would've seen we ended 2020, where the gross to net of 17% with Medicare part D and specialty pharmacy fees, making up the majority of all of that goes to the net.
And I would say it's.
It's a little early and the launch to provide any sort of the guidance on gross to net and.
You know we have finalized per their payer negotiations and have a better view of the evolving payer mix.
But I would hope.
That we would be able to provide that as we get more history behind us.
It makes a lot of the time thanks guys.
Thanks, Ted Thanks, Dan Thanks, Glenn.
The next question comes from the line of Brandon Folkes from Cantor Fitzgerald. Please proceed with your questions.
Hi, Thanks for taking my question and congratulations on the early launch and.
Maybe just carrying on and on the insurance topic.
Can you just talk about what is required for patient to switch from a and insurance perspective, and any restrictions on there was 150 million lives.
And maybe I'll just ask all my questions upfront and if you don't mind and Yep.
Any color on on the patient reported reported symptom control and practice today two of them or is it just too early to tell the and additionally, any color on how the switch they've gone during the titration period.
Ah patients generally happy with the experience. Thank you.
Hi, Brandon Thanks for your questions Hum.
On the payer coverage part as you know all the specialty drugs beyond a certain cost threshold on all of them have part of ops. So for four of our category, even the SSA injectables, although they've been there for a long time all of our prior ops and for US the prior of obviously.
Goes without a label, which is they have to be on Octreotide Orlando, the tide, injectables and you'll be able to be switched over.
Beyond that I don't think there's any more onerous restrictions from a payer perspective.
On the patient symptom part.
As you know, we do have a ongoing macro of registry.
That we hope to gather data on the current state of care and for those patients who get switched over.
By the physicians will be able to actually replicate and learn more about the real world effectiveness of my caps on with patients as we saw on the clinical trials. So we hope to learn more from the registered data, but anecdotally.
If I have to give you some of those comments out of come back Ah patients have been and.
For a lack of of better word have used words like game changer. This is <unk>.
The change their lives in terms of what it has done and it's it's not surprising to us given that in this particular environment with COVID-19, and my caps up fits very well not just with COVID-19 of the environment here, but it also fits well with telemedicine.
And in terms of switches I would say that.
The switches and not mentioned right.
The the biggest challenge we've seen is actually coordinating between the office staff in terms of making sure that the patient can be helped.
To get on my capsule.
I'll, let of non speak more to that but we haven't seen any particular challenges in terms of switching beyond what I had already commented in the previous questions.
Yeah, and thanks Raj so.
Brandon in terms of the the switching process, what Raj said is exactly correct and in terms of insurance and how that goes they just need to complete the prior authorization paperwork, which it really is very much in line with what we expected and what Raj laid out. It's just the as I said in my prepared remarks, the the challenge to some degree of has.
And then the Hcp's availability to actually complete what is generally routine prior authorization.
Work and once that starts to become a little bit more routinize, they're back and the office. They can they can see us more on the week and help.
And the ways that are appropriate I think that that will continue to speed up. The you had a question and it's part of what you asked in terms of just the the mix of times of insurance, it's very much in line with what we have and our corporate deck and what we saw in terms of the market before we launched were about 60% of.
And are on commercial therapy about a quarter of those are on a quarter or on the Medicare and Medicaid and others.
The accounts for the rest and so what we've seen and practice is very much in line with what the expectations had been and and lastly, I would just to build on Rogers point. The fact that we have is just now at this juncture have patients who have initiated on and really benefited from my caps the therapy and his as he said many.
And of them are having very positive experiences.
Part of our emphasis is in short of that that is getting communicated out both within the patient community as well as to the clinicians because that just builds confidence and understanding on the part of the prescriber as to the real need here and how transformative. This can be four of patient when they have a good experience with my capsule.
Great. Thank you very much.
Thanks Brandon.
Our next question is from the line of Douglas Tsao with H C. Wainwright, please share with your questions.
Oh, Hey, Christy all of a sudden for dog so to from US are the first question is about the empower of data you know there was a lot of investor feedback that we heard about the importance of the head to head comparison data between my caps and the Injectables or how is the data have been received.
And has it helped with the commercial uptake and the U S. And then our second question is are there any update on plans for developing my cap support carcinoid syndrome, or maybe any other indications. Thanks.
Yeah, Hey, Chris. Thank you so much for those questions and thanks for taking the place of Doug.
The I think on empower data. We're obviously very excited because this was the different trial with the direct head to head comparison with and active comparator, which was the injectables and showing non inferiority of demonstrating that and it's already was very important to us.
The important thing is I think at Endo, as we said and our prepared remarks, we have five late breakers that were accepted and as you know empowered.
And we've always talked about a treasure trove of data in terms of efficacy and safety symptoms and quality of life. So we look forward to presenting those data and we look forward to engaging in appropriate scientific discussions with.
Key opinion leaders in the country as warranted.
But on label.
And from a promotional perspective as you know Chris we are restricted to the optimal trial. So we will continue the focus on the optimal trial, but from the medical education perspective, and publications and abstracts. These would be the venues, where physicians and kols and payers would be able to glean more data in terms of the clinical.
Data that was added to my capstone.
In terms of the other question in terms of update on plans for Carcinoid syndrome.
We've always said this is a logical seems like a logical next step to expand the benefits of my caps up to that patient population. We're obviously doing a preliminary work within the company to be able to figure out what's the best.
The strategy on capital allocation in terms of of long term growth drivers at this point and time, we want to make sure whatever we decide on as the next best thing for key asthma in terms of driving long term growth. He is the right opportunity and at.
We will compete with the fully prepared story on on what that is and how that fits in with our current strategy, but at this time of the organization as I said before is very much focused on the launch and the U S launch and even the guidance that we gave for our Opex Chris.
Chris if you'll recall was very much focused on the U S launch and there was really no development programs that we're a year marked with them that opex guidance.
Awesome. Thank you very much.
Thanks, Chris.
Our next question is from the line of Kumar, Russia with Brookline capital markets. Please proceed with your questions.
Hi, Thanks for taking my questions and congratulations on all of the progress.
With regards to the phase one what's the space to sales force.
In terms of targeting a way of exactly at the right now in terms of Oh.
Proportion of the I'll call them and there have been able to target.
Hey Kumar. Thanks, I'll, just make maybe a brief comment and then I'll pass it onto a non.
You're probably the called from my Dan's prepared remarks the.
Phase one when we started we targeted a third of the top tier SSA writers.
Initially.
And then you know as we learned what works and what doesn't and we expanded to face to I'll, let and not speak more to where they are and how we have covered the universe that are not and referred to before on Ptc's and a high priority community endocrinologists and none.
Yes, Thanks Raj on the high Kumar of its good to talk to you and so when we went to sort of brushed covered phase one and with phase two and more than double the number of of people that are in the and the sales and the sales force. So we went from 10 people and field sales to 22 and.
And the one we had phase one that we did that with national coverage, but with very large territories and then within those large territories and the large geographical territories that we had those representatives focus on the higher priority accounts within that and the way that I and and.
Before in terms of the focus on the pituitary treatment centers being tops, but then also the other.
High volume community Endocrinologists and also manage these patients and we did see earlier on the skew towards both sales calls and the source of prescriptions more from the community and as of late we've started to see the pituitary centers and the academic centers contribute to a greater extent, because we continue to persist in terms of.
Trying to penetrate those accounts and we're starting to see some of the fruits of of that effort.
When we went to phase two what we essentially did was took the large geographical territories that were in place and just reduce them and size. So then each of the representatives could focus on a smaller number of accounts and provide more intensity on.
On that on the call base and so we went from being able and calling on a third and.
Is to essentially to about two thirds of the the the total customer base within that though we have a very large proportion of the treated patients and then we're putting emphasis and focus on them and driving it.
And do those accounts, but in addition to the to the breadth that we can get both having more representatives the.
And I mentioned again and my remarks, we're putting a lot of emphasis on depth because breadth in terms of getting more physicians to prescribe is challenging and the COVID-19 environment because to do that you have to be able to reach them and without going through everything from before the or the challenges in terms of being able to actually interact with those customers but.
And we're driving depth, we know that those physicians have written from the accounts that have experience with my caps and.
And that week and then we can then use that especially since many of them and creating multiple patients to get that second third fourth fifth patient and if they have that many to be converted to my caps and to drive that depth and that way and we're so we're putting a lot of energy and emphasis in this phase two in terms of trying to drive that depth as well.
And in terms of the open label extension patients getting on the commercial drug.
And what can you share in terms of where you guys thought from and also.
And what would be the strategy to get the.
The rest of those oily patients on the commercial drug.
And how is the commercial strategy evolving as the C. The vaccines and need on some of the states have started opening up so what are we seeing there.
And so on.
Go ahead.
Yeah. So on the open label extension the as I mentioned early on and the late third quarter early fourth quarter that was a lot of focus in terms of getting those patients converted onto commercial therapy.
The complete as of the the early part of the fourth quarter. So all of those patients.
The where the transitioned to commercial therapy or off of our at least come off of clinical drug.
And have done so and then through our <unk> process, we worked with those patients their providers or insurance companies to be able to provide them.
And so they could get access to therapy as well so what we've seen more recently in terms of prescriptions has.
Doesn't have any impact from the open label extension components of they're not they're of no more of those patients to be converted maybe there's a different way to be said, so we're really focusing on continuing to the drive switches from the injectable therapies.
On to onto my caps of at this stage.
The the latter question regarding you know, what we might anticipate whether it's vaccinations and other kinds of things. It's the once we get to a point what really matters is the reopening of the customers and of those accounts the face to face the interactions and when we have that we think that we've built a very strong foundation.
From the true this early phase when these restrictions have been in place through the adaptations of we've made through the the flexible strategy, we've employed and the traction that we've gotten to this point and then as access starts to open to that full of breath of accounts, we would see that further strengthening our our trajectory at that point.
Okay, and maybe of finally equation on the M&A strategy and.
Maybe you can share some details on where you are bearing debt.
And the strategy in terms of a.
Finding a partner and out of Hollywood and start thinking about launching in Europe.
The Thanks Kumar in terms of EU, we continue to keep our options open and we continue to explore options for collaborations with the right partners that have the right strategic fit.
And as we progress down that road and when we have something concrete obviously, we would we would announce that I think you know we remain open and when it comes to the EU and tons of options versus the U S, where we have made a clear decision to commercialize on our own.
Thanks, so much.
Thanks Kumar.
Thank you at this time of rich and of our question and answer session and I'll turn the call over to Raj Khanna of for closing remarks.
Thank you all for joining our call. This afternoon and 'twenty 'twenty, one will be another important year for the asthma and we look forward to meeting the state of milestones and we look forward to speaking with you again during our first quarter update and May have a very good evening. Thank you.
This concludes today's conference you may disconnect your lines at this time and thank you for your participation.