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Chiasma Inc (CHMA)
Q1 2020 Earnings Call
May 7, 2020, 5:00 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good afternoon, ladies and gentlemen and welcome to the Conference Call to discuss Chiasma's First Quarter 2020 Operating and Financial Results. [Operator Instructions]
At this time, I'd like to introduce Dawn Schottlandt, Vice President of Investor Relations and Corporate Communications. Please go ahead.
Dawn Schottlandt -- Vice President, Investor Relations and Corporate Communication
Thank you, operator. Today we will be making certain forward-looking statements about events and circumstances, including but not limited to statements regarding our development and potential commercialization of MYCAPSSA, our expectations on timing of the regulatory review process, plans and measures of our manufacturing supplements and release of clinical data. Our plans and expectations for US commercial launch, including the sufficiency of supplies MYCAPSSA to support our commercial launch in the United States. Our efforts to obtain regulatory approval of MYCAPSSA in the EU, our anticipated cash runway and capital needs and the size and composition of our potential markets for MYCAPSSA is approved.
These statements are based on current expectations. Actual results 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 SEC for the quarter ended March 31, 2020, as well as our subsequent filings with the SEC. 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 Mark Fitzpatrick, our President, who will review our financial results.
And now, I would like to turn the call over to Chiasma's Chief Executive Officer Raj Kannan. Raj?
Raj Kannan -- Chief Executive Officer
Thank you, Dawn. Thank you everyone for joining our call this afternoon to discuss our recent operating highlights, 2020 anticipated milestone and the first quarter 2020 financial results. Let me start by making a few comment on the COVID-19 pandemic and its impact on our business. My colleagues and I at Chiasma are adopting well to our new work environment. Like, most of you, we're working from home and have adopted well to a virtual meeting, settings. So far Chiasma from an operational standpoint has experienced minimal impact from the COVID-19 crisis to-date.
As you know we are fast approaching our PDUFA date for our investigational octreotide capsules MYCAPSSA. The FDA has not notified Chiasma of any expected delay to it's June 26, 2020 PDUFA target action date. We are continuing to work toward the date assuming approval will be repeat [Phonetic] and we continue to plan for an anticipated US commercial launch in the fourth quarter of 2020. The Chiasma team continue to evaluate our manufacturing supply chain for MYCAPSSA and remains in close contact with our suppliers. Assuming the approval of NDA and our planned prior approval manufacturing supplement, we believe we will have sufficient commercial supply of MYCAPSSA to support our planned commercial launch.
Lastly, on the COVID-19 impact, the empowered trial it's continuing with six patients active in the randomized controlled arm out of a total of 92 patients that were randomized. We are working with the clinical trial site to ensure the safety of the patients and the smooth working of the sites given the trial. Bill will provide more details, but of note, the trial has met the EMA requirement of a minimum of 80 patients randomized to the nine-month randomized controlled sale of the trial.
As we noted previously, the fourth quarter 2020 planned commercial launch of MYCAPSSA is dependent upon the FDA timely approval of our NDA and the approval of a planned prior approval supplement of an API manufacturer, [Indecipherable]. We continue to expect to submit our planned prior approval supplement for our primary API supplier shortly following our PDUFA date and we continue to anticipate approval of this API manufacturer in the second half of 2020.
Pertaining to our second planned prior approval manufacturing supplement that we plan to file courts approval, the FDA requested in April that we include certain stability data. We expect that responding to this request will delay our planned submission of the second API manufacturer supplement until early 2021. We continue to believe we will have commercial supply available to execute on the planned fourth quarter commercial launch of MYCAPSSA. However, to meet the goal, we're now dependent on the FDA approval of one planned prior approval supplement. We expect this supplier could adequately support the planned commercial launch of MYCAPSSA.
Moving on to our recent highlights. In April, we entered into a revenue interest financing agreement with Healthcare Royalty Partners for up to $75 million to support the ongoing development and will add commercial launch of MYCAPSSA. After a careful process of evaluating our financing options and several partners, we engaged HCR as a top tier investment firm. We believe it is beneficial to Chiasma to be partnered with an investor who is known to conduct extensive due diligence and whose returns are tied directly to MYCAPSSA's potential commercial success.
Also in April, we brought Anand Varadan on board as our Executive Vice President and Chief Commercial Officer. Anand has been advising Chiasma since early 2018, as a strategic consultant and he was the Chief Commercial Officer of Chiasma back in 2015, 2016. I'm extremely pleased to have a Anand back at Chiasma full time and I could not think of anyone more qualified to execute the planned commercial launch of MYCAPSSA. With the hiring of Anand, I'm confident we have built the right commercial leadership team to navigate the anticipated virtual customer interface environment including a shift to a model with telehealth may become the preferred means for physician visit. Overall we do believe that MYCAPSSA if approved will be reasonably well positioned in the COVID-19 world given its at home oral administration and otherwise injectable dominated market.
With that, I will turn the call over to Anand to highlight some of our initial efforts to adapt our planned MYCAPSSA commercialization efforts to the new customer interface environment. Anand?
Anand Varadan -- Chief Commercial Officer
Thank you, Raj. I'm incredibly excited to be back at Chiasma to help achieve the company's mission of providing patients with alternative options to injectable therapies. Like my other returning Chiasma colleagues, I really believed in the innovation represented by MYCAPSSA and the potential of the TPE platform. We definitely felt that we had let some unfinished business, so I'm really looking forward to bringing the first oral somatostatin analog to the patients if approved by the FDA.
Let me start with providing a high level overview of our pre-launch commercial activities, including our planning for the period when face to face access the customers may be restricted by social distancing mandates. As Raj said, we believe MYCAPSSA will be better positioned in COVID-19 world than other rare disease drugs launching during this time. First, it will be the only oral self-administered therapy in a market dominated by injectables, label for HCP administration.
The second, our planned launch of commercial product in Q4 allows more time for the current environment to settle into a new normal and for us to revise our plans as needed based on learnings from our early promotional experiences in Q3. Third, preliminary market research shows that endocrinologists who treat acromegaly patients are increasing their use of Telehealth and other remote means of interaction. And lastly, a significant number of endocrinologists and acromegaly patients are already familiar with octreotide, so they will not need to become comfortable with an entirely new mechanism of action.
Our team has spent the last several weeks revamping our promotional plans to significantly strengthen our digital and web-based campaign, as well as develop tools and programs adapted to remote personal promotion. We've begun implementing our non-branded campaign through digital media to educate patients, physicians and nurses on the treatment burdens currently borne by acromegaly patients. Finally, we've begun recruiting our customer facing team and plan to have promotional coverage of top tier accounts shortly after approval. We will carefully monitor the evolution in the marketplace in the effectiveness of our early promotional efforts to inform the scale up of our team and to address the full market when commercial product becomes available.
At this point, I'd like to turn the call over to Bill Ludlam to discuss our plans to present the CHIASMA OPTIMAL data and to provide an update on the MPOWERED trial. Bill?
William Ludlam -- Senior Vice President Clinical Development and Medical Affairs
Thanks, Anand. It has been a productive quarter for medical affairs. We had the challenge of engaging in medical education with healthcare providers remotely and compensating for the canceled conferences, including ENDO, ECE and ACE[Phonetic]. Our MSLs have been very active in reaching endocrinologist and connecting with them digitally using video and over the phone. I'm pleased with the progress through the team's ability to quickly adapt to a remote working environment.
In terms of the presentation of the CHIASMA OPTIMAL data, the ENDO Society, which canceled its Annual Conference in March has scheduled a virtual conference to take place June 8 through June 22. In addition, we expect ENDO to publish all seven of our accepted abstracts in the Journal of the Endocrine Society in the next several weeks. After that time, we anticipate we will be able to make our data available via our corporate website. Additionally, we expect to publish additional CHIASMA OPTIMAL date at ACE virtual conference in June and at the ECE Virtual conference this fall. We also believe we are on track to publish the CHIASMA OPTIMAL data in a peer-reviewed journal in mid-2020.
As Raj mentioned earlier the MPOWERED trial is ongoing. My team and I have been working with healthcare professionals at clinical sites to implement safety protocols for the remaining patients in the randomized controlled or RCT phase of the trial. Of the 92 patients randomized as octreotide capsules responders into the nine-month RCT phase 83 have completed the trial and six remained active in RCT. Importantly, the trial has met the EMA requirement of a minimum of 80 patients randomized to the nine-month RCT phase of the trial. The primary endpoint will be calculated with time weighted average or TWA analysis. Therefore missing monthly IGF-1 values are not anticipated to effect the completion of the primary endpoint analysis. We remain on track to report top line results in the fourth quarter of 2020 from this comparator study.
Lastly, we are continuing to enroll in our multi-year US disease state registry called the management of acromegaly registry or the macro registry. The registry is actively enrolling acromegaly patients currently receiving medical treatment such as injectable somatostatin analogues. The registry was designed to be conducted remotely meaning it does not require visits to the physician's office. As such, we do not expect a significant impact from COVID-19 on our enrollment objectives. Our plans for the registry is to involve over 40 US clinical sites, hundreds of patients and yield important real-world data on the current state of care, the treatment burdens for patients and effectiveness associated with various medical treatments.
With that, I will turn the call over to Mark Fitzpatrick to review the financials. Mark?
Mark J. Fitzpatrick -- President
Thank you, Bill. General and administrative expenses were $7.6 million for the first quarter ended March 31, 2020 compared with $2.5 million for the same period of 2019. The current period results include our continuing pre-commercial activities, an increase in compensation-related expenses and increased other administrative costs as we prepare for the potential commercialization of octreotide capsules in the US. Research and development expenses were $8.1 million for the first quarter ended March 31, 2020 compared with $6.5 million for the same period of 2019. The increase was primarily driven by the manufacturing of octreotide capsules to support our planned commercial launch, if approved, costs associated with our disease state registry, scientific literature publications and increased regulatory costs, which were offset by a decrease in clinical trial costs.
For the quarter ended March 31, 2020, net loss was $15.4 million or $0.36 per basic share compared with a net loss of $8.8 million, or $0.36 per basic share for the same period of 2019. In April, Chiasma entered into a revenue interest financing agreement with Healthcare Royalty Partners or HCR for up to $75 million to support the ongoing development and planned commercial launch of MYCAPSSA. Cash, cash equivalents and marketable securities as of March 31, 2020 were $79.3 million compared with $92.4 million as of December 31, 2019. In April 2020, the company received a $25 million payment less certain transaction expenses from HCR under the previously announced revenue interest financing agreement. If MYCAPSSA is approved by FDA in June we expect an additional $25 million in revenue interest financing to be provided to us by HCR in July.
I will now turn the call back over to Raj.
Raj Kannan -- Chief Executive Officer
Thanks, Mark. Before opening the call to questions, I would like to make a few comments. We remain acutely focused on achieving our stated milestones this year and in bringing the first oral somatostatin analog option to patients with acromegaly. If approved, we plan to make MYCAPSSA potentially the new standard of pharmacological care for adult patients with acromegaly.
As I look at our anticipated milestones, despite the current challenges in the world today, 2020 Bill has the potential to be a transformational year for Chiasma. Our PDUFA target action date for MYCAPSSA of June 26, 2020 is just around the corner and we believe we are well prepared to execute a successful commercial launch assuming positive regulatory outcome. Looking toward the end of 2020, our pipeline expansion efforts should start to materialize and we will be able to discuss our plan to develop one or more oral therapies utilizing RTB platform. That concludes our remarks.
We will now open the call for your questions. Operator?
Questions and Answers:
Operator
Thank you. [Operator Instructions] And our first question will come from Yasmeen Rahimi with Roth Capital Partners.
Yasmeen Rahimi -- Roth Capital Partners -- Analyst
Thanks, team. Thank you for the detailed update on great progress, as we continue into late especially in this environment. Two questions for you team. The first one is, can you give us a little bit more color in regards to the macro registry, especially around with COVID. How many patients have been already part enrolled into this registry study? What is the utility of these results mean for you? And then the second question is, can you give us a little bit more color in regards to the delay that you just announced related to launch the suitability study -- sorry, stability studies that you were doing? That would be great and thank you for taking our questions.
Raj Kannan -- Chief Executive Officer
Thanks, Yasmeen. Let me take sort of the second question, first and I'll make a comment and then hand it over to Bill. We haven't delayed the launch we're consistent with the guidance that we had given before in terms of expecting the launch to be in the fourth quarter. The change is that we had originally mentioned that we would be finding two prior approval supplements shortly after we get our PDUFA approval that would support our commercial launch. Now, the timing and the sequel has changed.
So we have one primary API supplier that we would be filing right after our PDUFA approval and this supplier is fully capable of supplying our need to support our commercial forecast. So that -- we can go into more details, if you want, but on the registry before I turn it over to Bill, this is a first industries wanted [Indecipherable], which really focuses on documenting state-of-care today and identifying gaps in treatment. So as to enable to generate data that could help HCP's in particular to improve patient outcomes. Bill, do you want to add more color to the registry data itself and the registry trials?
William Ludlam -- Senior Vice President Clinical Development and Medical Affairs
Yeah. Thanks, Raj. It was a great way to cheer up. So all set to this point is that the registry is enrolling. Our target is to bring up 40 -- 40 sites or more and hundreds of patients that is our anticipation. Everything is moving ahead as planned. You did specifically ask on the COVID-19 situations, and one of the things that we were very fortunate in the way we design this trial is it really can be done remotely and so sites can activate remotely, the patients can come in and can do their parts of it remotely. So very fortunately, we have not been adversely impacted by the COVID-19. And as I've stated, just a moment ago, everything on the registry is progressing as planned.
Yasmeen Rahimi -- Roth Capital Partners -- Analyst
Thank you, Bill. And then if I may ask Anand, a quick question. Can you share with us maybe as you resumed all the commercial planning? Has things changed fundamentally in the acromegaly market now than three, four years ago to the extent that you could tell us anything that is maybe different than when you were looking at the market, a few years back?
Raj Kannan -- Chief Executive Officer
Anand?
Anand Varadan -- Chief Commercial Officer
Yeah. Thanks,Yasmeen. So it's -- yeah, thanks. Thanks Raj. I'll tell you -- the comparison to a few years ago to now the thing that I'm continue to be heartened by the fact that when we speak with clinicians and patients there is demand for an oral option to therapies is strong as ever, and that's a very strong sign of the unmet needs that are in this market. And I think that also what we've -- what I found though that's changed since say 2016 to now is the appreciation of the treatment burdens that these patients there for viewing on injectable therapies has increased. And I think that's due to some work that's been done in the intervening time frame with -- that has helped to understand better the consequences of being on injectable therapies for these patients and much of that has started to be better understood, which is a, which is a good hopeful sign as far as the preparation of the market is concerned, as we continue to get when to launch into it.
Yasmeen Rahimi -- Roth Capital Partners -- Analyst
Thank you, team and the best of luck as we head into June.
Raj Kannan -- Chief Executive Officer
Thank you, Yasmeen. Thank you.
Operator
Next question will come from Douglas Tsao with H.C. Wainwright.
Douglas Tsao -- H.C. Wainwright -- Analyst
Hi. Good afternoon. Thanks for taking the questions. Just maybe Bill talk about when we think about launching and the possibility that there will still be social distancing thing measures in place and the risk of sort of second wave, so to speak. Obviously, the self-administer therapy there are significant advantages for MYCAPSSA. Can you talk about maybe some of the things that we might need to work at advanced that would allow a patient to transition some disease on injectable therapy and providing sort of clinicians comfort that as they move to MYCAPSSA that remain in biochemical control?
Raj Kannan -- Chief Executive Officer
Yeah. Thanks, Douglas. I think a couple of overarching comments before I hand it over to Anand. One, I think the launch in the fourth quarter really positions at relatively speaking better than companies that have the launch last week or this week. We do have the ability to pivot and high trade strategy to where our customers would be. And as we have said before, I think the launch focus has always been on patients in making sure that we provide them an absolute top-tier world-class sales and support system and more importantly in the physicians office supervisor, nurses tools that would allow for seamless switching and placed a burden away from the physicians office in terms of switching patients. In particular, I'll let Anand speak to the recent survey that we did and the findings that we have in terms of how endocrinologists have moved and what our plans are, and why we feel confident that in the current environment we should be able to drive the adoption and utilization of MYCAPSSA. Anand?
Anand Varadan -- Chief Commercial Officer
Yeah. Thanks, Raj. So Doug, the research that Raj is referring to is a survey that we did of endocrinologists, especially those who treat acromegaly to understand how they have to evolve their practices in this sort of COVID-19 environment. And one of the things that came out strongly from that, as I mentioned in my prepared remarks is, they're moving toward telemedicine other kinds of remote forms of interaction has been among the strongest of other -- of most specialties. And I think that's, in large part due to the fact that these clinicians don't necessarily have to be involved in interventions with these patients they can -- and because of that it lends itself more to those kinds of communications.
And also answer to your question, yeah, we -- octreotide orally MYCAPSSA is well suited for this environment because it's an oral therapy. But what can be -- everything that needs to be done from the point of the telemedicine console with the patient. to MYCAPSSA and stabilization can all be done in the contact free form as well. And so that is evident part of what led to the strength of this is that including the ongoing measurements that might need to happen in order until the patient stabilizes on therapy those can all be done in a remote fashion as well and I think the battle then to the data conversion process.
Douglas Tsao -- H.C. Wainwright -- Analyst
So just to clarify or just to confirm that point. So as a patient, you may sort of -- sort of titrating up and finalizing the dose. They don't need to come into the office, just sort of get measured this can be done on a telemedicine sort of remote basis as we sort of go through this period and also to your -- hear you again Anand and welcome back to the company.
Anand Varadan -- Chief Commercial Officer
Thanks, Doug. It's great to talk to you. And, yeah, no, absolutely the patient does need to have their blood drawn, they do need -- it doesn't need to be sent to a lab but those results can be then communicated back to the clinicians practice remotely and they can make any adjustments that are needed for dosing remotely as well. So really the only part of contact that needs to happen is to just draw the blood and sent it to the lab and that can be done in location up in the patients' home or in sites that are around the country where they can go in order to be able to provide that. So all of those different dimensions can be done in that manner.
Douglas Tsao -- H.C. Wainwright -- Analyst
And just one final quick question you may presumably -- you'll sort of the facilitating patients getting their blood drawn at their home or in a sort of easier way than necessarily going to like a treatments [Indecipherable]?
Anand Varadan -- Chief Commercial Officer
Yeah. We will be providing options at the disposal of the clinician if they want to take advantage of them, where that can be done on a remote basis. Many of them even today though are just directing their patients to go into a facility where they can have that done and to have their blood sent into whatever the lab of choices. But we plan to provide an additional option there. It can be done in the patients' home, so they don't have to venture out, which is not too.
Douglas Tsao -- H.C. Wainwright -- Analyst
Okay. Great. Thank you so much and congrats on all the progress.
Raj Kannan -- Chief Executive Officer
Thank you, Doug.
Operator
Our next question will come from Brandon Folkes with Cantor Fitzgerald.
Brandon Folkes -- Cantor Fitzgerald -- Analyst
Hi. Thanks for taking my questions and congratulations for the progress. Maybe just following on from an earlier question, which I would think finally ask that you elaborate on the commercial supply. Can you just help us think about and what is your capacity with one supplier and what percentage of the market can you supply? I mean, if we just thinking at the supplies it potentially equal supplied it's 50%, is that fair estimate or any color you can provide there? And I hopped in little bit late, but just to confirm so the FDA requested stability data from one of the suppliers and from the other supply you had that stability data, is that correct? And then I've got one more.
Raj Kannan -- Chief Executive Officer
Okay. Brandon, are you going to finish the questions or to be answer this one first?
Brandon Folkes -- Cantor Fitzgerald -- Analyst
Raj, do you [Phonetic] want to answer this one because the other one is -- it's got a bit of a different subject.
Raj Kannan -- Chief Executive Officer
Yes. The answer to your first question, as we mentioned in our prepared comments, the primary supplier that we plan to file shortly after PDUFA approval. It's fully capable of supporting our commercial needs. We had plan to put a secondary or second prior approval supplement to sort of diversify, but because we did not have stability data for that particular manufacturer and we need to produce taxability data. We are now looking at filing that side approval supplement in early 2021. Does that answer your question, Brandon.
Brandon Folkes -- Cantor Fitzgerald -- Analyst
It does. I just wanted to -- a little bit more detail maybe in terms of, if you do run and hit us full cost, how much headroom do you have there with the one supplier?
Raj Kannan -- Chief Executive Officer
So I'll give it in March, to give you a little more detail, but we've always had the capability of supplying our commercial forecast just with one manufacturer, API manufacturer. We added the second more to diversify our own API supplier base and we continue to look at our manufacturing in terms of diversifying or mitigating our risk across any of that value chain. I'll hand it over to Mark to add any other comments that he may have to answer, Brandon's question.
Mark J. Fitzpatrick -- President
Yeah. Thanks, Raj. So we have two APR manufacturers. One is Teva and the other is Bachem and the company has had those relationships for years as order in all the clinical trial material from both of these companies over the years. They -- between the two of them have three sites. And it's the new sites, they scaled up to stability of one of the manufacturers that doesn't have the stability data complete yet. It has always been a prior approval manufacturing supplement for that new location, because we didn't want to slow down the six months review process of our resubmitted NDA. We didn't want to include that particular new location in the resubmission, Brandon. So the stability data will be available later this year and that will lead to that supplement going in, we expect early next year. But from a capacity standpoint, from the suppliers we've ordered API to produce finished product from both of the suppliers. The suppliers are up and running and operational without interruptions in our CMOs as well. So we don't anticipate having any particular challenges with supply driven the now-sequencing of the prior approval manufacturing supplements [Indecipherable].
Brandon Folkes -- Cantor Fitzgerald -- Analyst
Great. That's actually very helpful. Thank you to both again. And then, so my next question just sort of following on a bit of the COVID being in. We talked a lot about switching patients from the long-acting injectables to MYCAPSSA, but can you just elaborate a little bit in terms of what goes into switching a patients who would not be well controlled in MYCAPSSA back to those long-acting injectable. Just so that a physician may have confidence in terms of using MYCAPSSA initially that, what is involved, should it not be successful in controlling the patients?
Raj Kannan -- Chief Executive Officer
So, great question, Brandon. In terms of the trial itself, as you would have noted, right, when we had the two arms and then they had through the revert to their injection that they came in, we saw that within about four week they were back to control with injectable and this is one of the attractive features that we had with MYCAPSSA which is with an easy switch back to the injectable for import any reason MYCAPSSA it's not tolerated or anything, it doesn't work according to the physicians expectation. I'll hand it over to Bill to provide a little more from his own profit and for the trial itself details about what goes into switched back with injectables.
William Ludlam -- Senior Vice President Clinical Development and Medical Affairs
Yeah, Brandon. So the MYCAPSSA is very short acting drugs. So you don't need to worry about long-term effects of the drug hanging around. So basically, once the patient opts, if they opt to go back to injectable they would simply just start taking the injectable again and they can choose if they wanted to have some overlap or they can just stop all at that point. Now even if a patient -- even if for some reason the clinician of the patient felt they wanted to go back to injectable for whatever reason, we're still going to expect that MYCAPSSA have some effect, so there should be a fairly smooth transition going from the oral back to the injectable and we will discuss simply the patient, the physician will simply this follow the patient through that process.
Raj Kannan -- Chief Executive Officer
Yeah. And Brandon if I add even from our trial rate, when we looked at patients who were stable and well controlled on injectables and they went on the MYCAPSSA arm, you saw clearly that 90% of them chose to remain on the oral even though these were stable and we're used to an injectable. So that is an encouraging data point that we think will be replicated in the real world as well.
Brandon Folkes -- Cantor Fitzgerald -- Analyst
Great. Thank you very much and good luck for the PDUFA [Indecipherable].
Raj Kannan -- Chief Executive Officer
Thanks, Brandon.
Operator
And next we will hear from Ted Tenthoff with Piper.
Ted Tenthoff -- Piper Sandler -- Analyst
Hi. Thank you very much for the update. I was really incurred secure the PDUFA appears to remain on track and even the early thoughts in terms of guidance and telemedical normally [Phonetic] make a lot of sense. I wanted to ask, maybe a little bit earlier, since a lot of those questions have been addressed. With respect to the platform technology, obviously, things are little bit stretched out by nearly in the company's focus is on MYCAPSSA and launch additional data out of Europe. But what are your plans at a higher level to start to kind of reenergize the [Indecipherable] and would that be for a proprietary efforts and partnering efforts. What are your thoughts on that? Thank you.
Raj Kannan -- Chief Executive Officer
Thanks, Ted. Great question. As you can imagine, just to reiterate our focus has always been where investors are looking at in terms of value creation, which is to make sure that we get the approval and we are absolutely execute on the successful launch. And I think as we get closer and closer to the end of the year once we have an approval and a launch in the rearview mirror, so to speak. We're already starting to plan as to what would be adjacent disease state and something that always competitive investors is the bigger sandbox where somatostatin analog injectable do participate which of [Indecipherable].
So we certainly are looking at various [Speech Overlap] sense of what's the optimal capital allocation, both in terms of where do we get the best sort of return on our investment and then we're also looking at potentially an additional molecule that we targeted a therapeutic area where there is a significant medical unmet need and commercially. It's quite attractive. We feel that I think by the end of the year, we'll have that the ability to actually articulate what our mid to long-term growth prospects are. At this time, obviously, we don't want to provide any guidance given sort of the COVID-19 in terms of even you're doing a few things around that pipeline is not going to be feasible and provide a clear view as to where our plans for 2021.
Ted Tenthoff -- Piper Sandler -- Analyst
Perfect. That's all makes a lot sense. Thanks so much and good luck with all the things going on. Thanks and stay healthy.
Raj Kannan -- Chief Executive Officer
Yeah. Thank you, Ted.
Operator
And with no further questions in the queue, I'd like to turn the call back over to Raj Kannan for closing remarks.
Raj Kannan -- Chief Executive Officer
Thank you, operator. So that concludes today's call. And in closing, I would like to acknowledge all of our employees who remain committed and engaged to bring MYCAPSSA to the patients who could potentially benefit from therapy. On behalf of the entire organization, I would like to -- want to express our gratitude to all the health-care workers on the frontlines, fighting the good fight and all personnel, it was the very essential services. You are truly our heroes. Thank you and thank you all again for joining us. We look forward to speaking with you throughout the quarter. Have a good evening.
Operator
[Operator Closing Remarks]
Duration: 41 minutes
Call participants:
Dawn Schottlandt -- Vice President, Investor Relations and Corporate Communication
Raj Kannan -- Chief Executive Officer
Anand Varadan -- Chief Commercial Officer
William Ludlam -- Senior Vice President Clinical Development and Medical Affairs
Mark J. Fitzpatrick -- President
Yasmeen Rahimi -- Roth Capital Partners -- Analyst
Douglas Tsao -- H.C. Wainwright -- Analyst
Brandon Folkes -- Cantor Fitzgerald -- Analyst
Ted Tenthoff -- Piper Sandler -- Analyst
