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Chiasma (NASDAQ:CHMA)
Q4 2020 Earnings Call
Mar 04, 2021, 5:00 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Good afternoon, ladies and gentlemen, and welcome to Chiasma's fourth-quarter 2020 conference call. [Operator instructions] Please note that today's conference is being recorded. At this time, I would like to introduce Glenn Garmont, investor relations. Mr.

Garmont, please go ahead.

Glenn Garmont -- Investor Relations

Thank you, operator. Welcome to the Chiasma 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 MYCAPSSA, including its potential market adoption and commercial success; the size and composition of the U.S. market for MYCAPSSA; the commercial and therapeutic potential of MYCAPSSA; and anticipated market acceptance and insurance coverage of and access to MYCAPSSA; our ability to convert endocrinologists and patients to MYCAPSSA from octreotide or lanreotide injections; our commercial organization strategy and efforts and potential sales and revenue growth; our expectations regarding financial results and the timing of our planned MYCAPSSA EU marketing application and whether the MPOWERED data will support marketing approval in the EU. 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 our plans or intentions or meet expectations. Actual results may or events may differ materially due to 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, Chiasma disclaims any obligation to update information contained in these forward-looking statements, whether as a result of new information, future events or otherwise.

Joining the call today is Raj Kannan, chief executive officer; Anand Varadan, executive vice president and chief commercial officer; Bill Ludlam, senior vice president of Clinical Development and Medical Affairs; and John Doyle, senior vice president and chief financial officer. At this point, I'd like to turn the call over to Chiasma's chief executive officer, Raj Kannan. Raj?

Raj Kannan -- Chief Executive Officer

Thank you, Glenn, and thank you to everyone for joining this call today. I will start my comments with a brief update on our MYCAPSSA U.S. phased launch and plans for MYCAPSSA EU marketing application submissions later this year. Anand 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 MYCAPSSA phased 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 end the year with 100 million covered lives. We did much better than this. As we reported in our January update and today's press release, we secured payer coverage of MYCAPSSA for over 150 million lives in 2020, which we believe reflects MYCAPSSA's strong value proposition and provide 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 burdensome treatment option for acromegaly. Our label allows us to promote MYCAPSSA to an estimated 99% of U.S. acromegaly patients on SSA injectables. We continue to believe that MYCAPSSA 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 a 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 a result of office closures, travel and other restrictions. In anticipation of this challenging environment, we adapted our launch strategy in two ways, which we have discussed previously. First, 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 endocrinologists and their acromegaly patients on the many benefits of MYCAPSSA.

With positive early feedback from prescribers, patients and payers due, in part, to our efforts to increase awareness of MYCAPSSA, we believe that as a more normalized business environment returns, allowing in-person sales calls, we are well positioned to drive continued growth for MYCAPSSA. Shifting to our Phase III MPOWERED study. We were excited to announce positive top line results in November. We're in the process of preparing a marketing authorization application plan for submission to the European Medicines Agency in midyear.

Recall that MPOWERED compared the MYCAPSSA efficacy safety symptoms and quality of life scores to those of patients treated with octreotide LAR or lanreotide depot injectables and further expanded the overall clinical data set for MYCAPSSA. In addition to supporting potential marketing approval in the EU, the positive results from MPOWERED add to the body of clinical evidence, demonstrating MYCAPSSA's safety and efficacy. We plan to submit these data for publication in 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 20 to the 23rd.

Five of the abstracts, all late breakers, have been accepted for poster presentation, and will highlight the MPOWERED data. These six will be an oral presentation on the long-term one-year efficacy and safety data from the open-label extension of our Chiasma OPTIMAL Phase III trial. Recall that 90% of subjects who received MYCAPSSA 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 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, including in connection with our phased commercial launch of MYCAPSSA.

At this point, I'll turn the call over to Anand for an update on our launch progress. Anand?

Anand Varadan -- Executive Vice President and Chief Commercial Officer

Thanks, Raj. Last quarter, I detailed the phased manner in 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 I with a focused sales team of 10 professionals calling on approximately one third of what we identified as key accounts. As Raj mentioned, we deployed technologies to enable remote engagement with customers and complemented these with enhanced digital media to reach and educate HCPs and patients.

We believe the encouraging feedback from the early interactions with HCPs and patients confirms the unmet need for an oral SSA option for patients and the appeal of MYCAPSSA's label and clinical profile. Additionally, we believe this early experience sheds light on the challenges that COVID-19 presents at this point in 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 were 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 HCPs and patients. For the time being, we feel the organization is rightsized to reach and support key target customers that will drive the initial launch trajectory, while still accounting for the current environment.

We plan to evaluate further expansion of our commercial team as market conditions warrant. Critical to a successful launch is ensuring that acromegaly patients who can benefit from MYCAPSSA are able to obtain insurance coverage. We have 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.

Because the U.S. acromegaly market is concentrated, with 90% of patients currently on injectable SSAs estimated to be treated at fewer than 1,000 medical practices, we're able to deploy an efficient and targeted commercial team. Our commercial efforts are focused on physicians in major pituitary treatment centers, or PTC, regional referral centers and a limited number of community endocrinologists. We've continued to put an emphasis on clinicians operating in PTCs who both see the highest concentration of patients and are influential on the treatment practices of their colleagues.

Despite the fact that the academic centers in which most PTCs operate who were impacted by pandemic-related restrictions to access, through the end of 2020, we've reached nearly 90% of PTCs with either a face-to-face or remote personal sales call or digital contact. Among the larger group of higher-priority non-PTC accounts, we've reached nearly half of them with either personal sales calls or digital contacts with the initial phase of our sales team. We expect to continue to expand our reach with the deployment of the second phase as of the beginning of this year. Also, as previously mentioned, we have upgraded our digital capabilities and tactics to complement our personal selling efforts.

Traffic to both our HCP and patient websites has exceeded our expectations. And the engagement of visitors to these sites, as indicated by the time they spend, the content they interact with and the materials they download, attest to the importance of this source of information during the pandemic. Although we've made steady progress in 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 into commercial shipments have been impacted by the reduction in patient visits to HCPs, limitations on access of sales personnel to 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 in the longer-term prospects of MYCAPSSA, which we continue to believe will become the standard of pharmacological care for the maintenance treatment of acromegaly.

The initial uptake of MYCAPSSA in the late third and early fourth quarters of 2020 was driven by patients HCPs identified as highest priority for an oral SSA and also the conversion of patients enrolled in the open-label extension phase of our Phase III studies. More recently, our new prescriptions have been entirely from nonclinical 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 endocrinologists earlier in the launch as they tended to operate in practices which were more open to our promotional efforts. Due to the diligent efforts of our sales team, we've begun to penetrate PTCs to a greater extent, and they've been an increasing source of new prescriptions.

With the expanded second phase of our selling efforts, we're focused on driving greater depths of prescribing among HCPs who have already initiated and have experience with patients on MYCAPSSA. Depths of prescribing will be especially important among PTCs and the highest volume accounts as they tend to have multiple SSA patients eligible for conversion to MYCAPSSA. The conversion of prescriptions into commercial shipments was similarly impacted in the near term by the inaccessibility of HCPs needing to complete prior authorization documentation for payers. It's important to note that the nature of the prior authorizations and the documentation needed have been generally in line with our expectations, but the time frame HCPs have required to complete documentation is longer than would be expected in a non-COVID environment.

We believe that the significantly expanded payer coverage we have achieved will be helpful in increasing the speed and efficiency of conversion to commercial shipments until office staffing returns to more normal patterns. Overall, although the timing is difficult to predict since many of the COVID-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 as the environment becomes more favorable. Now let me turn the call over to John for a review of our financial results.

John Doyle -- Senior Vice President and Chief Financial Officer

Thank you, Anand. Revenue for the three months ended December 31, 2020, was $1 million. Revenue for the full-year 2020 was $1.1 million, at the upper end of the range that we provided in our January 6, 2021, business update. Selling, general and administrative expenses were $13.6 million for the fourth quarter ended December 31, 2020, as compared with $5.9 million for the same period of 2019.

Selling, general and administrative expenses were $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, an increase in personnel-related expense and other administrative costs to support the commercialization of MYCAPSSA in 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 in current year period results were primarily driven by the pre-approval 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 in clinical trial costs. Manufacturing costs related to the production of commercial supplies of MYCAPSSA following FDA approval are now capitalized to inventory and no longer recorded as an R&D expense. For the quarter ended December 31, 2020, net loss was $19.8 million or $0.32 per basic share compared with a net loss of $12 million or $0.29 per basic share for the same period of 2019.

For the full-year 2020, net loss was $74.8 million or $1.43 per basic share, compared with a net loss of $36.3 million or $1.06 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 compared with $92.4 million as of December 31, 2019. We believe our cash balance is sufficient to fund our operations as currently planned through at least the next 12 months, including the continued execution of our U.S. MYCAPSSA commercial launch.

Looking ahead, as we outlined in our business update on January 6, we anticipate full-year 2021 operating expenses to be in the range of $80 million to $90 million, including estimated stock-based compensation expense in the range of $5 million to $6 million. This guidance is based on our current U.S. commercial plans and excludes expenditure for potential launch preparations of MYCAPSSA 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 2021, we're confident in the commercial team that we have assembled and the infrastructure that we put into place and believe it will support the launch trajectory as the pandemic subsides and a more normalized business environment prevails. Now I will turn it over to Raj. Raj?

Raj Kannan -- Chief Executive Officer

Thank you, John. Let me wrap up by saying I'm excited about our momentum at Chiasma in 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 reopens.

We look forward to submitting our application for marketing approval for MYCAPSSA in the EU, which if approved, would allow us to expand the benefits of MYCAPSSA to patients outside the U.S. We will now open the call to take your questions.

Questions & Answers:


Operator

[Operator instructions] And our first question is from the line of Chris Howerton with Jefferies. Please proceed with your question.

Chris Howerton -- Jefferies -- Analyst

Great. Thanks everybody for taking the questions and congratulations on the progress. So a few questions for me with respect, I think, maybe we could start with, obviously, the commercial launch, very important piece of the story right now. So one of the things, Anand, that you mentioned was the receptivity of your marketing efforts in the context of the different centers, community versus the pituitary treatment centers.

And so I guess, I would like to better understand the strategy as it relates to kind of, let's say, the available TAM that you have right now in terms of accessible centers that might be reachable by 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? So that's one question. Another question that I have is around, if you're seeing any refill rates yet? And if so, what have those been? Third is what, if any, expectations you're 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.

Raj Kannan -- Chief Executive Officer

Yes. So Chris, this is Raj. Just give maybe a couple of overarching statements and then let Anand address some of that in more granularity. Thanks for your questions.

I think in general, the in-person visits and the virtual visit within the PTC, there's not much of a difference in terms of the call itself and educating our HCPs within PTCs. I think where the in-person does become important is facilitating the paperwork that sometimes is necessary in a rare disease area like ours, where we'll 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 give it COVID-19, we faced some challenges early on with the office dynamics breaking down, where that facilitation with nurses being remote and physicians being remote has been quite difficult.

I think on the refill rates, it's a little bit too early to comment on that. But all I can say, Chris, is there's nothing that has been surprising in terms of a fallout. So I think the comment that we made in our 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 making good progress with payers, and we hope to continue that coverage and that progress in 2021.

And we believe that by in 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. Anand, did you want to add anything to what I just responded?

Anand Varadan -- Executive Vice President and Chief Commercial Officer

Yes. Thanks, Raj, and also, Chris, for the question. Let me answer your question regarding the strategy that we employed entering the marketplace. And so we obviously had the opportunity in the months before launch to be able to prepare as best as we could for this COVID environment and restrictions to access and the like.

Strategically, we did tier our accounts. So we put the pituitary treatment centers at the top as the top priority accounts. And because both they have the concentration of patients and then they also have influence to a broader body of endocrinologists that also have acromegaly patients. And then also then we tiered the community-based customers based upon the volumes that we understood that they were to have.

I think the adaptation that we needed to make to the strategy, Chris, was that although you want to go where the business is and right at the top of the PTCs, they tended to be the ones that had the most restrictions to access. Especially early on, and then throughout the fourth quarter, it relaxed for a little bit into the end of Q3 and then tightened up again in terms of access restrictions in Q4. So what we did is continue to persist with those accounts until we could penetrate them more fully. But we then expanded our focus to a bit of a broader base because we wanted to get some momentum going in terms of the prescribing of the product.

And then as the access was able to be gained within the PTC setting, and we said like through the end of the year, we've gotten 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 the pituitary treatment center. And that's going to be important for our ongoing momentum as we head into this year. So strategically, we needed to be adaptive, both with the kinds of calls we make and then where we targeted and focus on them. And 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 is certainly going to be a high one.

And in fact, in some instances, you get longer period of time with those customers in order to be able to deliver a full sales call where you don't get that full opportunity face to face. But what you do get when you have face-to-face access and what we found is to be able to move the call continuum along faster, from when you first introduced MYCAPSSA to them understanding the patient types that's appropriate for, to wanting to prescribe the product, identifying and bringing that patient in so they can actually put the prescription into place. And then once the prescription is there to help that we can help to facilitate in terms of their ability to do the prior authorizations and the like and work with their office staffs 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 at more infrequent times, then that's going to slow down the process.

And that's the essential distinction that we're seeing between face to face and remote on that front. So I think that on refill rates and coverage, Raj captured most of it. If you had further detail you wanted on that, I can try to help you with that as well.

Chris Howerton -- Jefferies -- Analyst

No. No. That's really helpful. And I guess maybe as a follow up to that, it's striking to me that it sounds like that the in-person visits are very impactful to convert a physician to a prescribing physician and that maybe other types of visits or touch points would be OK as long as they've already been converted.

Is that kind of a fair read on what you're seeing out of things?

Anand Varadan -- Executive Vice President and Chief Commercial Officer

Yes. I think that, first of all, the remote calls, the video conference call, Zoom or whatever, came a little later in the launch timing, right? So you're spending time before launch, trying to 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 with a face-to-face call, and we saw this very early in the launch phase, you can just get the process moving. But then you're exactly right that when you do have a face-to-face discussion and you're able to -- 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, it's a phone call, email, in order to then continue to propel that process through.

But there's really -- 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 certainly had an effect in these early days.

Chris Howerton -- Jefferies -- Analyst

OK. And I said I was done, but maybe one more question, if I may. What about specific metrics in terms of the launch strength or launch health in terms of patients on drug? Number of prescribing physicians? Do you have any plans to provide any of that kind of information?

Anand Varadan -- Executive Vice President and Chief Commercial Officer

So we do have plan...

Raj Kannan -- Chief Executive Officer

Go ahead, Anand.

Anand Varadan -- Executive Vice President and Chief Commercial Officer

Yes. 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 factors of where we are right now in that trajectory, I think would not provide the clarity that I think you and your colleagues and everybody else would want about how things are going.

So as soon as we have a sense that those kinds of metrics, it would really be informative in terms of the true trajectory of the launch and then also things that we're seeing, that hopefully are changing in a positive direction as the environment becomes more favorable, I think we would definitely want to be sharing those metrics to you.

Operator

The next question is from the line of Ted Tenthoff with Piper Sandler. Please proceed with your question.

Ted Tenthoff -- Piper Sandler -- Analyst

Good evening everybody and thanks for the update. 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 you real time?

Raj Kannan -- Chief Executive Officer

Hi Ted, this is Raj. Thanks for your question. Because we have a specialty pharmacy and we have a patient support program where patients do opt in, we have a very close monitoring, so to speak, of where the prescriptions are coming from, who the patients are, obviously with a firewall just to be compliant. From an organizational standpoint, we do not know the patients' names or any details, but we do have a very good sense from where those prescriptions are coming from.

Beyond that, Anand, did you want to add something?

Anand Varadan -- Executive Vice President and Chief Commercial Officer

No. Ted, we follow it extremely closely. Clearly, there's no metric that's more relevant to our progress, the distribution system that Raj described allows us to have instantaneous understanding of where that is. And so that helps a lot in terms of being able to track that and put the emphasis and focus where we need to continue to drive that trajectory.

Ted Tenthoff -- Piper Sandler -- Analyst

That makes a lot of sense. And then just with respect to pricing, it's still probably a little bit early, but I think you guys quoted like $5,152 price for 40 mg, 28-day supply. Is that looking just with respect to the sort of weighted average in terms of what people are using? And maybe any gross to net discount? Trying to get a sense on how pricing is sort of starting to hold up in the real world. Thanks.

Raj Kannan -- Chief Executive Officer

So Anand, let me take a crack at this and then you can add commentary if I've missed something. So Ted, great question. I think in terms of price, we're at $5,384 for a 40-milligram per day, 28-day supply. Remember, we had said we had set this price in a way that predominantly becomes a replacement for payers.

And that's what you see, which is a significant progress being made with payers today from the price value equation. I'll let Anand weigh in more with details on the other part of your question. Anand?

Anand Varadan -- Executive Vice President and Chief Commercial Officer

Yes. Thanks, Raj. So Ted, in terms of weighting of the doses, we're still seeing more of the patient. A lot of these patients are in that initial phase of being introduced onto MYCAPSSA.

They're being started predominantly on the 40-milligram dose. And so then as titration is necessary, then we would start to see those move up as we did in our clinical trial setting. But at this juncture, the fact that the patients came in at the 40 for the most part, would mean that, that's where the tilt is in terms of our dose spread at this point. And we'll see how that goes.

The one exception of that or some of the patients that 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 MYCAPSSA at those higher doses as well.

Raj Kannan -- Chief Executive Officer

The other part of the question, Ted, was the gross to net. As you would have seen, we ended 2020 with a gross to net of 17%, with Medicare Part D and specialty pharmacy fees making up the majority of that gross to net. And I would say that it's a little early in the launch to provide any further guidance on gross to net, unless we have finalized further 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.

Ted Tenthoff -- Piper Sandler -- Analyst

Thanks Raj

Raj Kannan -- Chief Executive Officer

Thanks Ted.

Operator

The next question comes from the line of Brandon Folkes with Cantor Fitzgerald. Please proceed with your question.

Brandon Folkes -- Cantor Fitzgerald -- Analyst

Thanks for taking my question and congratulations on the early launch. Maybe just carrying on the insurance topic. Can you just talk about what is required for a patient to switch from an insurance perspective? And any restrictions on those 150 million lives? And maybe I'll just ask one more questions on front, if you don't mind. Any color on the patient report reported symptom control in practice to date? Or is it just a little bit too early to tell there? And additionally, any color on how the switch they've gone during the titration period? Are patients generally happy with the experience?

Raj Kannan -- Chief Executive Officer

Thank you Brandon, thanks for your questions. On the payer coverage part, as you know, all specialty drugs beyond a certain cost threshold, all of them have prior ops. So for our category, even the SSA injectables, although they have been there for a long time, all have prior ops. And for us, the prior ops, obviously, goes with our label, which is they have to be on octreotide or lanreotide injectables to 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 an ongoing macro registry that we hope to gather data on the current state of care. And for those patients who get switched over by those physicians will be able to actually replicate and learn more about the real-world effectiveness of MYCAPSSA with patients as we saw in the clinical trials. So we hope to learn more from the right data.

But anecdotally, if I have to give you some of those comments that have come back, patients, for lack of a better word, have used words like game changer. This has completely changed their lives in terms of what it has done. And it's not surprising to us given that in this particular environment with COVID-19, MYCAPSSA fits very well, not just with COVID-19, the environment here, but it also fits well with telemedicine. And in terms of switches, I would say that switches, as Anand mentioned, right, 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 MYCAPSSA.

I'll let Anand speak more to that, but we haven't seen any particular challenges in terms of switching beyond what Anand had already commented in the previous questions.

Anand Varadan -- Executive Vice President and Chief Commercial Officer

Yes. Thanks, Raj. So Brandon, in terms of the switching process, what Raj said is exactly correct in terms of insurance and how that goes. They just need to complete that prior authorization paperwork, which really is very much in line with what we expected and what Raj laid out.

It's just, as I said in my prepared remarks, the challenge, to some degree, has been the HCP's availability to actually complete what is generally routine prior authorization work. And once that starts to become a little bit more routinized, they're back in the office, they can see us more and then we can help in the ways that are appropriate. I think that, that will continue to speed up. The -- you had a question as part of what you asked in terms of just the mix of times of insurance, it's very much in line with what we have in our corporate deck and what we saw in terms of the market before we launch where about 60% of patients are on commercial therapy.

About one fourth are on Medicare, and then Medicaid and others account for the rest. And so what we've seen in practice is very much in line with what the expectations have been. And lastly, just to build on Raj's point, the fact that we have, at this now, at this juncture, have patients who have initiated on and really benefited from MYCAPSSA therapy, and as you said, many of them are having very positive experiences, part of our emphasis is to ensure 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 for a patient when they have a good experience with MYCAPSSA.

Operator

Our next question is from the line of Doug Tsao with H.C. Wainright. Please proceed with your question.

Chris Bialas -- H.C. Wainwright -- Analyst

Hey Chris Bialas on for Doug. So two from us. The first question is about the MPOWERED data. There was a lot of investor feedback that we heard about the importance of the head-to-head comparison data between MYCAPSSA and injectables.

How has that data been received? And has it helped with commercial uptake in the U.S.? And then our second question is, are there any update on plans for developing MYCAPSSA for carcinoid syndrome or maybe any other indications?

Raj Kannan -- Chief Executive Officer

Hey Chris, I think on MPOWERED data, we're obviously very excited because this was a different trial with a direct head-to-head comparison with an active comparator, which was the injectables. And showing noninferiority or demonstrating noninferiority was very important to us. The important thing is, I think at ENDO, as we said in our prepared remarks, we have five late breakers that were accepted. And as you know, MPOWERED , we've always talked about a treasury trove of data in terms of efficacy, 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 our label, again, from a promotional perspective, as you know, Chris, we are restricted to the OPTIMAL trial. So we will continue to focus on the OPTIMAL trial. But from a medical education perspective and publications and abstracts, these would be the venues where physicians and KOLs and payers would be able to gain more data in terms of the clinical data that was added to MYCAPSSA.

In terms of the other question in terms of update on plans for carcinoid syndromes, we've always said this seems like a logical next step to expand the benefits of MYCAPSSA to that patient population. We're obviously doing preliminary work within the company to be able to figure out what's the best strategy on capital allocation in terms of our long-term growth drivers. At this point in time, we want to make sure whatever we decide on as the next best thing for Chiasma in terms of driving long-term growth is the right opportunity. And we will come to you with a fully prepared story on what that is and how that fits in with our current strategy.

But at this time, the organization, as I said before, is very much focused on the launch in the U.S. launch. And even the guidance that we gave for our opex, Chris, if you recall, was very much focused on the U.S. launch, and there was really no development programs that were earmarked within that opex guidance.

Chris Bialas -- H.C. Wainwright -- Analyst

Awesome. Thank you very much.

Raj Kannan -- Chief Executive Officer

Thanks Chris.

Operator

Our next question is from the line of Kumar Raja with Brookline Capital Markets. Please proceed with your question.

Kumar Raja -- Brookline Capital Markets -- Analyst

Thanks for taking my questions and congratulations on all the progress. With regard to the Phase I versus Phase II sales force, in terms of targeting, where exactly are they right now in terms of proportion of the accounts they have been able to target?

Raj Kannan -- Chief Executive Officer

Kumar, thanks. I'll just make maybe a brief comment, and then I'll pass it on to Anand. If I recall from announced prepared remarks, the Phase I, when we had started, we targeted one third of the top-tier SSA writers initially. And then as we learned what works and what doesn't, we expanded to Phase II.

I'll let Anand speak more to where they are and how we have covered the universe that Anand referred to before on PTCs and high-priority community endocrinologists. Anand?

Anand Varadan -- Executive Vice President and Chief Commercial Officer

Yes. Thanks, Raj. Kumar, it's good to talk to you. And so when Raj covered Phase I.

And with Phase II, we more than doubled the number of of people that are in the sales force. So we went from 10 people in field sales to 22. And when we had Phase I, that we did that with national coverage, but with very large territories. And then within those large territories, meaning large geographical territories, that we had those representatives focus on the higher priority accounts within that, the way that I answered before in terms of the focus on the pituitary treatment centers being tops, but then also the other high-volume community endocrinologists that also manage these patients.

And we did see earlier on, a skew toward 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've continued to persist in terms of trying to penetrate those accounts, and we're starting to see some of the fruits of that effort. When we went to Phase II, what we essentially did was took the large geographical territories that were in place and just reduce them in size so then each of the representatives could focus on a smaller number of accounts and provide more intensity on that call base. And so we went from being able -- calling on a one third to essentially to about two thirds of 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 then driving into those accounts. But in addition to the breadth that we can get both having more representatives, as I mentioned again in my remarks, we're putting a lot of emphasis on depth. Because breadth, in terms of getting more physicians to prescribe, is challenging in the COVID environment because to do that, you have to be able to reach them. And without going through everything from before, there are the challenges in terms of being able to actually interact with those customers.

But when we're driving depth, we know that those physicians have written for MYCAPSSA, have experience with MYCAPSSA, and that we can then use that, especially since many of them are treating multiple patients, to get that second, third, fourth, fifth patient, if they have that many to be converted to MYCAPSSA and to drive that depth in that way. And so we're putting a lot of energy and emphasis in this Phase II in terms of trying to drive that depth as well.

Kumar Raja -- Brookline Capital Markets -- Analyst

And in terms of the open-label extension patients getting on the commercial drug, what can you share in terms of where you guys are? And also what would be the strategy to get the rest of those OLE patients on the commercial drug? And how is the commercial strategy evolving as we see the vaccines and some of the states have started opening up, so what are we seeing there?

Raj Kannan -- Chief Executive Officer

So I'll...

Anand Varadan -- Executive Vice President and Chief Commercial Officer

Go ahead, Raj.

Raj Kannan -- Chief Executive Officer

Yes. So on the open-label extension, as I mentioned early on, in the late third quarter, early fourth quarter, that was a lot of focus in terms of getting those patients converted on to commercial therapy. That's complete as of the early part of the fourth quarter. So all of those patients that were to transition to commercial therapy or at least come off of clinical drugs have done so.

And then through our CAPS process, we work with those patients, their providers or insurance companies to be able to provide them so they could get access to therapy as well. So what we've seen more recently in terms of prescriptions doesn't have any impact from the open-label extension component. So there are no more of those patients to be converted. Maybe as a different way, as you said.

So we're really focusing on continuing to drive switches from the injectable therapies on to MYCAPSSA at this stage. The latter question regarding what we might anticipate, whether it's vaccinations and other kinds of things. Once we get to a point, what really matters is the reopening of the customers on those accounts to face-to-face interactions. And when we have that, we think that we've built a very strong foundation from -- through this early phase when these restrictions have been in place, through the adaptations that we've made, through 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 breadth of accounts, we would see that further strengthening our trajectory at that point.

Kumar Raja -- Brookline Capital Markets -- Analyst

OK. And maybe finally, a question on EMA strategy. Maybe you can share some details on where you are there and your strategy in terms of finding a partner or how you guys are thinking about launching in Europe?

Raj Kannan -- Chief Executive Officer

Thanks, Kumar. In terms of EU, we continue to keep our options open. We continue to explore options for collaborations with the right partners that have the right strategic fit. As we progress down that road and when we have something concrete, obviously, we would announce that.

I think we remain open when it comes to the EU in terms of our options versus the U.S. where we had made a clear decision to commercialize on our own.

Kumar Raja -- Brookline Capital Markets -- Analyst

Thanks so much.

Raj Kannan -- Chief Executive Officer

Kumar, thank you.

Operator

At this time, we've reached the end of our question-and-answer session, and I'll turn the call over to Raj Kannan for closing remarks.

Raj Kannan -- Chief Executive Officer

Thank you all for joining our call this afternoon. 2021 will be another important year for Chiasma, and we look forward to meeting the stated milestones, and we look forward to speaking with you again during our first quarter update in May. Have a very good evening. Thank you.

Operator

[Operator signoff]

Duration: 51 minutes

Call participants:

Glenn Garmont -- Investor Relations

Raj Kannan -- Chief Executive Officer

Anand Varadan -- Executive Vice President and Chief Commercial Officer

John Doyle -- Senior Vice President and Chief Financial Officer

Chris Howerton -- Jefferies -- Analyst

Ted Tenthoff -- Piper Sandler -- Analyst

Brandon Folkes -- Cantor Fitzgerald -- Analyst

Chris Bialas -- H.C. Wainwright -- Analyst

Kumar Raja -- Brookline Capital Markets -- Analyst

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