Chiasma (CHMA) Q3 2020 Earnings Call Transcript

Chiasma (CHMA)
Q3 2020 Earnings Call
Nov 05, 2020, 5:00 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Thank you for standing by. This is the conference operator. Welcome to the Chiasma Inc. third-quarter 2020 earnings conference call.

As a reminder, all participants are in listen-only mode and the conference is being recorded. [Operator instructions] I would now like to turn the conference over to Glenn Garmont of investor relations. Please go ahead.

Glenn Garmont -- Investor Relations

Thank you, operator. Welcome to Chiasma's third-quarter 2020 earnings conference call. Earlier today, we issued our third-quarter 2020 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 U.S.

commercialization of MYCAPSSA including its reimbursement and market adaption; the size and composition of the US market for MYCAPSSA; the commercial or therapeutic potential of MYCAPSSA and anticipated market acceptance of and access to MYCAPSSA; the success of the commercial launch of MYCAPSSA in the United States; our ability to convert endocrinologists and patients to MYCAPSSA from octreotide and lanreotide injections; our commercial organization strategy and efforts and potential sales and revenue growth; our expectations regarding financial results; and the timing of top-line results from the empowered trial and potential application for EU marketing approval. 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 or events may differ materially due to numerous risks and uncertainties, including those detailed in the Risk Factors section of our Form 10-Q filed with the Securities and Exchange Commission for the third quarter ended September 30, 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 obligations to update the 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 Mark Fitzpatrick, president and principal financial officer.

And now, I'd like to turn the call over to the Chiasma's chief executive officer, Raj Kannan. Raj?

Raj Kannan -- Chief Executive Officer

Thank you, Glenn, and thank you to everyone for joining the call today. I will start my comments today with an overview of our exciting MYCAPSSA U.S. launch and provide an update regarding our planned Phase 3 empowered study data release. Anand will provide a deeper dive into our U.S.

commercial launch progress to date and then Mark will review our third quarter and year-to-date 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 reviewing our launch progress to date. As a reminder, we received FDA approval of MYCAPSSA on June 26 of this year.

MYCAPSSA is the first and only oral somatostatin analog for the maintenance treatment of acromegaly patients in a market that has been dominated by somatostatin analog injection or SSA, which are both painful and burdensome. We continue to believe that MYCAPSSA has the potential to become the new standard upon ecological care. Our label allows us to promote MYCAPSSA to an estimated 99% of the patients on SSA injectables and acromegaly. These are patients who have responded to and tolerated treatment with either octreotide or lanreotide.

Our strong and growing clinical data profile for MYCAPSSA was highlighted in a July publication in the Journal of Clinical Endocrinology & Metabolism, a highly respected top-tier journal. The article provided a detailed review of our Phase 3 Chiasma OPTIMAL trial results in acromegaly patients. Of particular note, the paper highlighted that MYCAPSSA can be an effective maintenance therapy for those patients previously controlled with injectable somatostatin analog. For example for those patients treated with MYCAPSSA in the study, the means of their IGF-1 was maintained within normal limits.

Patients and physicians appear to have a positive experience with the oral octreotide capsules as 90% of MYCAPSSA-treated patients opted to continue into the open-label phase of the trial despite the burden that clinical trials may place on patients and their families. To us, this suggests a strong preference for all treatment in patients previously controlled and successfully switched from octreotide or lanreotide injection. Finally, the publication noted that the observed safety profile of MYCAPSSA with similar to injectable forms of somatostatin analogs, minus the injection-side reaction, and that no new or unexpected safety signals were observed with MYCAPSSA. We're pleased with the progress of our phased commercial launch to date and the early feedback from prescribers, patients and payers has been positive.

Recall that we made MYCAPSSA available in early September, ahead of our fourth-quarter expectations. In addition, we've made significant progress in gaining active and in driving awareness with payers. We expect MYCAPSSA to be covered by payers representing over 100 million lives before the end of this year. Our market research indicates that awareness of MYCAPSSA among healthcare providers and patients remains strong and continues to increase.

In this competitive market, we're fortunate to have great talents recruited, trained, and placed in the field. We continue to expand our reach with both community endocrinologists and with pituitary treatment centers or PTC. From my perspective, the leading indicators from the first two months of our launch have been encouraging and we are pleased with the progress to date. Despite the current challenging environment with COVID-19, which Anand will discuss in detail in a few minutes, we expect we will continue to grow MYCAPSSA in the fourth quarter and beyond based on the significant unmet need that we believe remain in this marketplace.

Shifting to our third Phase 3 study MPOWERED we're excited to announce that we expect to release top-line results later this month. If the data are positive, we would expect to complete our marketing authorization application for submission to the European Medicines Agency or EMA in mid-2021, MPOWERED will compare the MYCAPSSA efficacy, safety, symptom, and quality-of-life scores for those of patients treated with octreotide LAR or the lanreotide depot injectable and further expand our overall clinical data set for MYCAPSSA. Lastly, we believe we are well-capitalized to fully fund our U.S. launch plan.

We ended the third quarter with approximately $177 million of cash, cash equivalents, marketable securities, and restricted cash. You'll note from both Anand and Mark's comments that our spending increases over the course of 2020 have been responsible and measured, including during our pre-commercial launch of MYCAPSSA. At this point, I will turn the call over to Anand for an update on our launch progress.

Anand Varadan -- Executive Vice President and Chief Commercial Officer

Thanks, Raj. I'm excited to share additional details on the early progress in our U.S. commercial launch of MYCAPSSA, but first, let me provide a reminder of our phased launch strategy. As we've mentioned previously, in light of the multiple challenges presented by the impact of COVID-19, we have faced our launch to allow us to deploy our resources efficiently, as we learn and adapt to the changing marketplace.

We initiated the first phase of field activity at the end of July with a little over 20 customer-facing personnel, including a sales team of ten territory business managers and clinical nurse liaisons. This team engaged customers for approximately a month before commercial product was available in order to introduce Chiasma, begin educating on MYCAPSSA and our patient service offerings, build relationships with new customers and prepare for the commercial launch. We also learned valuable insights on the tactical mix that is most effective in this environment. During this first phase, we confirmed our conviction in the attractive commercial opportunity for MYCAPSSA and the important role, it can play in alleviating the significant burdens imposed by injectable SSAs on acromegaly patients.

As we had expected, our wave 1 team also confirmed that COVID-19 presented headwinds, which have impacted the selling, prescribing, and patient fulfillment process. This underscores the importance of the mix of promotional tactics we have deployed including remote selling, face-to-face calls were permissible and significantly enhanced digital tools of engagement. Based on the progress and learning from the wave 1 team, we decided to advance to the second phase of our launch by adding an additional 12 territory business managers and clinical nurse liaisons to be in the field during the fourth quarter. We're in the process of hiring and deploying this wave 2 team on a rolling basis, with three-quarters of this team now in the field.

After wave 2 is fully deployed into the field, we plan to wait until the marketplace appears broadly and consistently reopen to face-to-face interactions before commencing our planned final wave of hiring, which we expect to ultimately bring us to our planned full strength of 45 customer-facing personnel, which includes the salesforce, field management, patient case managers, and the payer account team. With that background in place, I'm pleased to share with you select relevant indicators of our early launch progress to date. As is common in rare disease markets, HCPs initiate MYCAPSSA prescription by sending a consented patient enrollment form or PEF into Chiasma's dedicated in-house patient services group, which we call Chiasma Access and Patient Services or CAP. We're pleased with the solid progress and receiving PEFs for both patients who were to be initiated on MYCAPSSA for the first time, as well as for the conversion to commercial product of U.S.

MYCAPSSA patients who are enrolled in the open-label extension phase of both the OPTIMAL and MPOWERED trial. We believe this reiterates the strong unmet need for an oral SSA and that MYCAPSSA is viewed as an attractive therapeutic option for acromegaly patients. To date, both community-based endocrinologists and those practicing in pituitary treatment centers have prescribed MYCAPSSA, which we believe speaks to the broad appeal of the MYCAPSSA profile. We found HCPs in pituitary treatment centers, we tend to treat higher concentrations of acromegaly patients can be challenging to reach with in-person calls since they are located in academic and institutional settings where COVID-19 related barriers to face-to-face engagements can be more restrictive.

To overcome this, we've been able to schedule remote calls for example, via video conference to reach many of these customers, but this has elongated the anticipated selling cycle from patient identification to the submission of TEFs. These efforts do seem to be gaining traction as we have recently seen an increase in the volume of TEFs from pituitary treatment centers. Looking forward, we are excited about the anticipated impact of our newly hired wave 2 sales team who we expect will contribute to our momentum by expanding the reach and frequency with potential prescribers. Once TEFs are received, the proportion that convert into revenue-producing shipment and the time frame over which this happens is variable at this stage of the launch.

The processing time for PEFs can currently be up to six weeks or more in some instances, due to the manual and iterative prior authorization process for reimbursement that is common before payers issue coverage policies. We anticipated the need to personally help patients that HCPs navigate the process to obtain access to MYCAPSSA and prepare by fielding and experience well-trained and equipped patient services CAPs team. Our commercial team members are very excited to have patients who have now initiated therapy with the first and only oral SSA. We anticipate that the speed and efficiency of converting TEFs into commercial shipment to improve as additional payers formalize their coverage policies in the coming months.

We believe the efforts of our experience market access team who've been calling on payors for the past several months, are producing good progress toward MYCAPSSA coverage. Before the end of this year, we expect to have coverage with payers representing more than 100 million lives. We are actively communicating with a broad set of payers, including national pharmacy benefit managers and integrated delivery networks to continue expanding access to more patients and further support ACP intent to prescribe. Other indicators of awareness of and potential demand for MYCAPSSA are also encouraging.

Traffic volumes to both our HCP and patient websites and 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 is above industry benchmarks. We believe this validates our decision to invest more heavily in engaging digital content as customers appear to rely on this source of information during the pandemic. Our market research with clinicians indicates a strong intent to prescribe MYCAPSSA in the future and patients indicate they plan to inquire specifically about MYCAPSSA during their upcoming medical visits. Our research also suggests HCP's intend to honor patient request for MYCAPSSA if it is medically appropriate.

We expect that these factors, along with our expanding selling efforts should continue to build on early launch momentum and importantly provide a solid foundation for potential growth in 2021. Now, let me turn the call over to Mark for his comments on the financials from our first quarter with commercial revenues.

Mark Fitzpatrick -- President and Principal Financial Officer

Thank you, Anand. As was summarized by Raj at the outset of the call, we believe we are now well-capitalized for the US commercial launch of MYCAPSSA given our strong cash position as of September 30 following our recent financing activity. As we have emphasized in the past, we will continue to prudently manage our cash resources to ensure that we are investing wisely in the business to further stockholder value. Since the commercial availability of MYCAPSSA was announced at the end of August, we recognized approximately $142,000 in net product revenues in September, made up of the initial shipments to our specialty pharmacy.

Selling, general, and administrative expenses were $13 million for the third quarter ended September 30, 2020, compared with $4.1 million for the same period of 2019. Selling, general, and administrative expenses were $31.3 million for the nine months ended September 30, 2020, compared with $9.2 million for the same period of 2019. The current-year results include our pre-commercial and post-approval sales and marketing activities, which were 6.6 and $15.2 million for the three and nine months ended September 30, 2020, respectively. An increase in compensation-related expenses and increased other administrative costs to support the commercialization of MYCAPSSA in the United States.

Research and development expenses were $4.5 million for the third quarter ended September 30, 2020, compared with $4.1 million for the same period of 2019. Research and development expenses were $22.3 million for the nine months ended September 30, 2020, compared with $16.1 million for the same period of 2019. The increase in current-year period results were primarily driven by the pre-approval manufacturing of octreotide capsules to support our US 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 since FDA approval are no longer captured in R&D expense but are now capitalized inventory. For the quarter ended September 30, 2020, net loss was $18.5 million for $0.30 per basic share, compared with a net loss of $7.7 million or $0.20 per basic share for the same period of 2019. For the nine months ended September 30, 2020, net loss was $55 million or $1.13 per basic share, compared with a net loss of $24.3 million or $0.77 per basic share for the same period of 2019. Given the many variables associated with our commercial launch, which recently commenced, and the ongoing uncertainty of the COVID-19 environment, it would be premature to provide financial guidance for the remainder of 2020 in 2021 at this time; however, the following information may be helpful.

Our operating expenses in the first nine months of 2020 were $53.6 million. These expenses included increasing pre-commercial expenses, as well as the costs of gradually expanding, training, and deploying our customer-facing team. As of the end of October, we currently have 85 full-time employees. Immediately following MYCAPSSA's approval, we began incurring commercial-related costs that we expect will continue to increase.

In addition, if we have positive MPOWERED trial results later this month, we anticipate increased spending for our EMA submission in 2021. Finally, we expect additional cost for potential pipeline product development to be relatively low until we progressed further into the U.S. launch of MYCAPSSA. We ended the third quarter with $177.1 million of cash, cash equivalents, marketable securities, and restricted cash, compared with $92.4 million as of December 31, 2019.

In April 2020, the company announced the revenue interest financing agreement with Healthcare Royalty Partners for up to $75 million and, since that time, have received an aggregate of $65 million in financing under this arrangement. In July, we also raised approximately $75.5 million of net proceeds from our underwritten public equity offering. Upon completion of these financing activities, we believe we have adequate capital to achieve our planned commercial and developmental milestones including top-line data from our Phase 3 MPOWERED trial expected later this month, EMA regulatory submission planned for next year if the MPOWERED trial is positive and anticipated US revenue growth and pipeline advancement utilizing our TPE technology in 2021. Now, I will turn it over to Raj.

Raj Kannan -- Chief Executive Officer

Thank you, Mark. Before we open the call for questions, as many of you know, we recently announced plans for Mark's transition from the company. On behalf of the entire team and the board of directors of Chiasma, I would like to thank Mark for the dedication, perseverance, and leadership over these past five-plus years. We're grateful to have mark on our team for a few more months as we continue to search for his successor and position the company for sustainable long-term success.

Let me wrap up by saying how excited I am about our momentum at Chiasma in having met all of our key milestones this year to date despite a challenging environment. We believe we are building a strong foundation going into 2021 when we expect a strong US launch trajectory to take shape as the business environment hopefully reopens. We look forward to releasing the MPOWERED data later this month, which is positive, is expected to support an application for marketing approval for MYCAPSSA in the EU and potentially allows us to expand the benefits of MYCAPSSA to patients outside the U.S. Over the next few weeks, we are scheduled to present at various virtual sell-side investor events.

In addition, we're hosting a key opinion leader webinar on November 30, and we encourage all of you to join. We will provide additional details as the event nears on our website. We will now open the call to take your questions.

Questions & Answers:

Operator

We will now begin the question-and-answer session. [Operator instructions] Our first question comes from Ed Tenthoff with Piper Sandler. Please go ahead.

Ed Tenthoff -- Piper Sandler -- Analyst

Hey, thank you so much, and congratulations on becoming a commercial company.

Anand Varadan -- Executive Vice President and Chief Commercial Officer

Thank you.

Raj Kannan -- Chief Executive Officer

Thank you, Ed.

Ed Tenthoff -- Piper Sandler -- Analyst

So I'm sure there's going to be a lot of questions on MYCAPSSA, so I'm going to kind of skip ahead and really talk about sort of the pipeline a little bit. When do you think -- again, with MPOWERED obviously the primary focus, when do you guys think you'll start to disclose some other programs that you're thinking about pursuing now that the technology has been validated? And then I have a quick follow-up on the financials.

Raj Kannan -- Chief Executive Officer

Yes. Thanks, Ed. That is an important question. However, at Chiasma right now, our current focus is obsessively to execute well on the U.S.

launch, and honestly, there is no priority that we think is more important to the company at this time, which we believe is a critical driver of value for the organization. I think when we will have the launch under way, Ed, we think it's best to sequence the announcement of our potential plans to drive long-term growth with the potential new development opportunities that we've been exploring.

Ed Tenthoff -- Piper Sandler -- Analyst

Great. Makes a lot of sense. Thank you very much. And I'm looking forward to seeing some additional commercial results with the fourth quarter and into 2021.

Raj Kannan -- Chief Executive Officer

Thanks, Ed. Us, too.

Operator

The next question comes from Brandon Folkes with Cantor Fitzgerald. Please go ahead.

Brandon Folkes -- Cantor Fitzgerald -- Analyst

Hi. Thank you for taking my questions, and congratulations on the launch. Firstly, we recently saw data from a competitor also developing economical products, albeit a lot earlier. I was wondering if you had any comment or you had launched any comments in terms of how you view that data from a competitive standpoint? And then secondly, given that we will get MPOWERED later this month, I envision a few questions on this opportunity, so could you maybe just talk about sort of the range of options that you're thinking about for commercialization there and then how that market is holding up.

I think there's some commentary about standard of care in the EU, so just any color there would be great as well just as we look forward to how big that opportunity is going to be relative to yours, which is obviously going to be the major opportunity. Thank you.

Raj Kannan -- Chief Executive Officer

Yes. So let me see if I can sequentially address your questions, Brandon. Thank you for your questions. First and foremost, on the competitive dataset, that was well -- the other company was making an oral molecule and putting into development.

Let me make an overarching statement before I hand it over to Bill, our internal medical expert and endocrinologist. We hold to an industry-standard, in not comparing across trials and make any conclusive statements unless it's a head-to-head study. I will also say that we're pleased that there is another oral agent in development that validates the unmet need in this patient population. For the actual data that we saw that was released recently, I'll hand it over to Bill to provide his perspective on the data and his clinical perspective on it.

Bill?

Bill Ludlam -- Senior Vice President of Clinical Development and Medical Affairs

Thanks, Raj. To your point, one should be really careful about making comparisons between trials. Edge and OPTIMAL have two very different patient populations, from a baseline IGF-one standpoint in a very different study duration. The patient populations that are similar across the two agents, MYCAPSSA and [Inaudible], are the EVOLVE and OPTIMAL studies as both studies enrolled well-controlled patients on their injectable baseline.

In the evolved study for the kinetics corporate deck in their recent Street call transcript at eight weeks, their time point of randomization, only seven of 13 patients could be randomized with an IGF-1 less than or equal to 1.0x the upper limit normal. In other words, 54% maintain IGF-1 in the normal range. We have not previously recorded this, but at the same 8-week time point in Optimal 82% of MYCAPSSA patients were maintained in the normal range. As Raj mentioned, they have built up outlook maintenance therapy for those patients previously controlled with injectable somatostatin analogs.

And I'll turn it back to you, Raj.

Raj Kannan -- Chief Executive Officer

Thanks, Bill. And I would build on Bill's comments again. You know, this was broad response to your question, Brandon. However, I would not make any conclusions based on these data points.

Like I said, I'm pleased, but there is another option being made available an oral option being made available to patients in this particular marketplace. In our estimate, we are way ahead in terms of infringing ourselves into the market and we look forward to the other molecules generation of data in terms of proving their similarity to the current standard of care. In regards to your next question in terms of Europe and other markets, obviously, as we said, we're excited to look forward to the date this month when we release the MPOWERED top-line data results. We hope to file in the EU sometime in the middle of 2021 assuming the data are positive.

Now, our plans are to keep our options open for potentially commercializing MYCAPSSA in Europe and in other markets with the directly or through one of our more potential collaboration arrangements. In summary, I think at this point in time, we have no conclusions or no decisions made in choosing the option that makes the most sense for Chiasma, both on a strategic and financial basis. Brandon, did you have a third question on MPOWERED? If you could repeat that for me, please.

Brandon Folkes -- Cantor Fitzgerald -- Analyst

It was just that with MPOWERED coming this month, just asking about the European opportunity given that -- even though you've just launched in the U.S. That was very helpful. Thank you, Raj, and congrats again.

Raj Kannan -- Chief Executive Officer

Thanks, Brandon.

Operator

[Operator instructions] The next question comes from Douglas Tsao with H.C Wainwright. Please go ahead.

Chris Bill -- H.C. Wainwright -- Analyst

Hey, everyone. Chris Bill on for Doug. Congrats on becoming a commercial organization. Two quick questions, the first one is the provider community is fairly concentrated.

What portion of accounts have you engaged with so far and how many do you ultimately hope to reach? And the second question is if MPOWERED comes back positive, how do you expect this data to impact U.S. commercialization? Thank you.

Raj Kannan -- Chief Executive Officer

Yeah. Hi, Chris. Thanks for those questions and thanks for sitting in for Doug. Let me just address the first question in terms of our reach and frequency.

As you know, that we made a very smart -- what we believe smart and hybrid approach to phasing our launch plan, which is that we doubled down on the digital and virtual remote engagement tools and placed the customer-facing team on the ground in phases which allowed us to learn what works and what does not. And as you heard from Anand's remarks, we decided to double that initial wave 1 salesforce recently. Even though COVID-19 has presented challenges, we've been able to learn and adapt our plans quite well over the last couple of months. That being said, let me pass it on to Anand to provide more color in terms of our effectiveness in reaching our targeted customers.

Anand?

Anand Varadan -- Executive Vice President and Chief Commercial Officer

Thanks, Raj. I appreciate it. So to reiterate, we launched with a team of 10 reps and nurses, and we wanted to have them focused on the higher-priority accounts but then also for us to learn what it takes to be able to interact with customers when face-to-face interactions might be restricted and you have to find other ways of being able to engage them. And we're really pleased with what this team has been able to do given their limited numbers in reaching these key accounts.

To give you some examples, we reached about three-quarters of pituitary care centers, which are the Centers of Excellence that treat acromegaly patients and that also represent higher concentrations of acromegaly patients as well. And we've done that both with personal sales calls either face-to-face or via video conference or via other digital tools of engagement as well. Then we've also branched into the larger group of higher-volume endocrinologists that are not in pituitary care centers, and we've reached nearly 40% of those accounts with either personal selling calls or with digital engagement as well. And we estimate that in those two categories of accounts that we targeted during this first wave, that over half of the patients that are treated for acromegaly are represented in that population.

What we learned from that first wave and with the limited numbers that that team had, we decided to expand on that effort by more than doubling the size of that selling team. And they are in the process, as I mentioned in my prepared remarks, of being hired and deployed and then getting out the field. But the positive learnings that we had from wave 1 really contributed to our decision to expand that effort and to capitalize on the learnings that we've had so far.

Raj Kannan -- Chief Executive Officer

Thanks, Anand. The other question, Chris, that you had was the potential for the MPOWERED data is positive for incorporation into the U.S. label if that's correct. So as you recall, MPOWERED is a large base.

Yes. Sorry, Chris.

Chris Bill -- H.C. Wainwright -- Analyst

It was not so much about the label. I just wanted to see how that would affect the U.S. sales potentially.

Raj Kannan -- Chief Executive Officer

I would say that MPOWERED, given sort of the study size and potential to generate data from a comparative basis against the injectables on efficacy, safety, symptoms, and quality of life, there would be a high level of interest among KOLs and academics to understand how that adds to data that we generated in OPTIMAL. So this is something that I know that we've heard anecdotally from our KOLs that they are looking forward to getting that data. And it certainly is complementary to what we have already generated. And I might add, for a rare-disease product, this is atypical in the type of the robust clinical database that we've already generated with three large studies that provide a degree of comfort for physicians to think about what patients would be appropriate for therapy as they think about it in acromegaly.

Does that answer your question, Chris?

Chris Bill -- H.C. Wainwright -- Analyst

Yes, it does. Thank you for the details.

Raj Kannan -- Chief Executive Officer

Thanks, Chris.

Operator

The next question comes from Kumar Raja with Brookline Capital Markets. Please go ahead.

Kumar Raja -- Brookline Capital Markets -- Analyst

Congratulations on the launch and thanks for taking my questions. First, with regard to the 100 million life potentially that will be covered by the end of the year, what percentage of acromegaly patients does that encompass? With regard to the macro registry, where are we with regard to the enrollment of patients? And how is that being delivered for the launch?

Raj Kannan -- Chief Executive Officer

Yep. Thanks, Kumar, for those questions. I think at this point in time, it would be difficult for us to parse out exactly how many patients would belong to those different plans because, remember, we are projecting this as 100 million lives that we will have across the plan that we're negotiating with that currently don't have formulary or formal coverage policies in place. So we hope to update you maybe at our next earnings call in the type of peers that have provided formerly the coverage for MYCAPSSA in the fourth quarter or before the end of the year.

And we hope to be able to answer that question better when we have that data. In terms of the macro registry -- before I go to the macro registry, let me pass it on Anand if he wants to add any color to that statement. Anand?

Anand Varadan -- Executive Vice President and Chief Commercial Officer

Thanks a lot, Raj. Kumar, good to speak with you. Regarding the 100 million lives, if you think about it, there's about 300 million lives that are covered by the major payers. We anticipate that acromegaly patients are going to be broadly distributed across the country and across payers, just like anybody else.

They don't aggregate in any particular space. They're not predominantly, for example, Medicare or Medicaid patients. So they have a payer mix which is broadly representative of the population. So I think that that 100 million being about a third of the total covered lives would give you a sense of the proportion of the acromegaly patients that will be contained in there as well.

Raj Kannan -- Chief Executive Officer

Thanks, Anand. On the macro registry, Kumar, let me just make a statement. I think we're very pleased with the progress. This is the first of its kind in terms of the interest that we've seen from physicians.

And to enroll into this registry program and start documenting the current state of the state-of-care, we hope to generate meaningful real-world evidence through this registry. Let me hand it over to Bill to add any color to our macro registry that we're excited about. Bill?

Bill Ludlam -- Senior Vice President of Clinical Development and Medical Affairs

Thanks, Raj. Kumar, thanks for the question. As Raj said, we're very excited about the registry, its capacity to collect data on real-world patient experience on variety of treatment options. And it's progressing very well, a lot of engagement with patients and various centers around the country.

It's the U.S.-only registry, and we'll look forward in the months ahead as we begin to do data cuts in publishing that data and making it available to others.

Kumar Raja -- Brookline Capital Markets -- Analyst

Thanks.

Raj Kannan -- Chief Executive Officer

Kumar, does that answer your question?

Kumar Raja -- Brookline Capital Markets -- Analyst

Yeah. Thank you so much.

Operator

This concludes the question-and-answer session. I would like to turn the conference back over to the presenters for any closing remarks.

Raj Kannan -- Chief Executive Officer

Thank you, operator. I would like to close the session by recognizing acromegaly awareness day on November 1st, where Chiasma reiterated our support to the patients and patient advocacy organizations fighting the good fight. Having met many of the patients with acromegaly, it is truly an honor to partner with them in making their lives better. Thank you all for participating in our last earnings call for 2020.

We look forward to speaking with you again when we release the top-line results from MPOWERED later this month. Thank you and speak with you all soon.

Operator

[Operator signoff]

Duration: 46 minutes

Call participants:

Glenn Garmont -- Investor Relations

Raj Kannan -- Chief Executive Officer

Anand Varadan -- Executive Vice President and Chief Commercial Officer

Mark Fitzpatrick -- President and Principal Financial Officer

Ed Tenthoff -- Piper Sandler -- Analyst

Brandon Folkes -- Cantor Fitzgerald -- Analyst

Bill Ludlam -- Senior Vice President of Clinical Development and Medical Affairs

Chris Bill -- H.C. Wainwright -- Analyst

Kumar Raja -- Brookline Capital Markets -- Analyst

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