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MyoKardia, Inc. (MYOK) Q2 2019 Earnings Call Transcript

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MYOK earnings call for the period ending June 30, 2019.

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MyoKardia, Inc. (MYOK)
Q2 2019 Earnings Call
August 7, 2019, 4:30 p.m. ET


  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Good day, ladies and gentlemen and welcome to MyoKardia's second quarter 2019 financial results conference call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question and answer session and instructions will be given at that time. If anyone should require assistance during the call, you may press * then 0 on your touch tone telephone. As a reminder, this call is being recorded.

It is now my pleasure to introduce Michelle Corral. Please go ahead.

Michelle Corral -- Head of Communications and Investor Relations 

Thank you so much, Andrew. Good afternoon and thank you all for joining us for today's call. I'm Michelle Corral, MyoKardia's Head of Corporate Communications and Investor Relations. Today, we will be reviewing second quarter financial results as well as recent progress and upcoming milestones across our portfolio. The second quarter financial results press release was issued earlier this afternoon and is available on our website.

Leading today's call is MyoKardia's CEO Tassos Gianakakos. Tassos is joined by Dr. Jay Edelberg, our SVP of Clinical Development, and Taylor Harris, our Chief Financial Officer. Following their prepared remarks, we will open the line for Q&A, for which Jake Bauer, our Chief Business Officer, will also be joining. Please note that during the Q&A segment, we ask that you limit yourself to one question.

As a reminder, the information discussed during this call will include forward-looking statements, which represent the company's view as of today, August 7th, 2019. We undertake no obligation to update or revise any forward-looking statements to reflect new information or future events except as required by law. Please refer to today's press release as well as our filings with the SEC for information concerning risk factors that could cause actual results to differ materially from those expressed or implied by these statements.

I'd like to now hand the call over to our CEO. Tassos?

Tassos Gianakakos -- President and Chief Executive Officer

Thanks, Michelle. Good afternoon and thanks for joining us today. MyoKardia is now within a year of results from our pivotal EXPLORER trial that could enable submission of our company's first new drug application for mavacamten in obstructive HCM. With screening now finished and full enrollment to be completed within days, we sharpen the timeline for completion of our registration program, allowing us to really key in on NDA-related and market development planning and prep activities.

It's incredibly energizing to all of us at MyoKardia to consider just how close we are to our first filing and potential introduction of the first ever targeted therapy for HCM. HCM is a progressive disease that affects over 6,000 Americans in the prime of life. Physicians are limited in how they can manage this complex and debilitating condition, with available approaches that manage symptoms in only some patients some of the time and don't really have options that actually treat the underlying disease.

Getting in new treatment to patients and physicians, one with the potential to not only reduce symptoms and improve function, but also to slow down or reverse disease progression would be an incredible advancement in patient care and a much needed one. That's exactly what we've set out to achieve. MyoKardia is the leader in the science and the treatment of HCM.

Our company has the broadest pipeline and scientific platform specifically focused on HCM. We continue to invest in understanding the disease science and supporting people with HCM, their families, and those who care for them.

Based on the hard work of our team, the enthusiasm of the investigators in our clinical trial and their staff and the patients that participated in the study, enrollment in EXPLORER is ahead of schedule, accelerating topline data released to the second quarter of 2020 compared to our previous guidance of second half 2020, which has positive knock on effects on NDA submission and if approved, subsequent launch liming.

We closed new patient screening a few weeks' back and as of today, have enrolled over 240 patients. That's more than our target of 220, with the final few remaining patients in screening to be enrolled within the next several days.

Between now and accelerated EXPLORER topline results, we've got multiple de-risking and value-creating data sets to share across our pipeline. Specifically, for mavacamten in obstructive HCM, 36-week data from PIONEER-OLE have been accepted for presentation at the European Society of Cardiogloy Congress, taking place in Paris at the end of this month, and 48-week OLE data have been accepted for presentation at the American Heart Association annual meeting taking place in Philadelphia in November.

So far, the OLE data has provided evidence supporting mavacamten's durability and safety with encouraging changes seen over 24 weeks and important biomarkers that correlate to improved outcomes, including NT-proBNP, LA volume index, and E over E-prime. Similar results over the 36 and 48-week timeframe would further increase our confidence in mavacamten and a successful EXPLORER study.

Looking at non-obstructive HCM, mavacamten's second indication and a very important one for MyoKardia, we announced completion of enrollment in the Phase 2 MAVERICK study in May and are on track to release topline data in the fourth quarter. We expect MAVERICK to be successful, with success defined as the identification of the appropriate dose or doses which will enable us to move mavacamten into registration studies and non-obstructive disease. Jay will talk more about this later on the call, as well as how MAVERICK results could help MyoKardia address diastolic heart failure, a syndrome with no approved therapies that affects an estimated 2.5 million Americans.

Beyond mavacamten, our second HCM program candidate, MYK-224, is set to begin dosing in healthy volunteers this month 224 is a novel molecule that possess distinct pharmaceutical properties that we plan on studying in HCM patients, underscoring our commitment to disease area leadership through a portfolio of potential therapies.

Before the end of this year, we'll share important Phase 2 data from MYK-491. 491 is intended to increase cardiac contraction in patients with reduced systolic function. We've been really encouraged by our Phase 1 results thus far and believe 491 can be an important new therapy with a best in class profile in a disease area that needs novel treatments. Results from the Phase 2 will be reported in the fourth quarter of this year. At that time, we expect to outline the next steps in the 491 development program, which will include studying targeted indications where systolic dysfunction is the key underlying driver of clinical burden.

With that overview, I'd like to hand things over now to Jay, who will talk about the latest on our EXPLORER and MAVERICK trials of mavacamten. Jay?

Jay Edelberg -- Senior Vice President of Clinical Development

Well, thanks, Tassos. Good afternoon to everyone. Enrollment in our EXPLORER pivotal study is nearing completion and will be fully enrolled within the next several days. This has been great effort by our development team in collaboration with our steering committee, study investigators, and coordinators, as well as, of course, the patients participating in the study.

EXPLORER is the largest and most comprehensive randomized clinical trial of obstructive HCM patients conducted to date. More than 70 sites in 13 countries have actively contributed to enrolling more than 240 patients in what we anticipate to constitute a landmark trial. Our team strategically prioritized higher volume HCM centers to enable the recruitment and retention in this comprehensive study. We have been in regular contact with our sites to provide training and support in collecting the wealth of data demanded by the EXPLORER trial protocol.

We believe a key factor in the successful enrollment and execution of this study has been and will continue to be the extensive site and investigator engagement conducted by MyoKardia's clinical development organization. The efforts by our team have met and matched with a remarkable level of enthusiasm and commitment among the clinical investigators and their staff.

Having spent time visiting many of the sites myself, I can attest to the excitement among the clinicians at the prospect of a targeted therapeutic for HCM, supported by the growing body of promising data generated for mavacamten.

Our focus in the study execution will continue as we collect data associated with EXPLORER's primary and secondary endpoints, including New York Heart Association classification and peak VO2, which make up the components of the primary clinical response endpoint, as well as serving as stand-alone secondary endpoints. These endpoints will capture mavacamten's impact on both exercise function and day to day symptoms.

We believe this reflects what patients, clinicians, and their caregivers care most about, feeling and functioning better. The selection of these endpoints was directly informed by our learnings from the Phase 2 PIONEER HCM study.

Non-obstructive HCM is driven by the same genetic mutations as obstructive HCM. In both cases, these mutations result in the formation of excessive myosin acting cross bridges in the sarcomere that result in thickening of the heart. In non-obstructive disease, this thickness occurs lower in the left ventricle and symptoms of disease are triggered by the lack of compliance of the left ventricle during diastole. Data from our clinical and pre-clinical studies of mavacamten also give us reason to believe that it will have a positive effect on patients with non-obstructive HCM.

The most recent example comes from the PIONEER-OLE data set presented at the ACC, in which we observed some encouraging evidence of mavacamten's potential to move the HCM cart closer to the normal state across several echo and plasma biomarker endpoints, including NT-proBNP and left atrial volume size. These were not directly linked to gradient and therefore may be indicators of long-term benefit.

The MAVERICK Phase 2 trial is one of the first and largest randomized clinical trials in patients with non-obstructive hypertrophic cardiomyopathy. MAVERICK is a dose-ranging study, with a primary endpoint of safety and tolerability. Patients in MAVERICK have been assigned to one of three groups to receive once-daily doses of mavacamten targeting two dose concentrations centered around 200 and 500 nanograms per mL or placebo.

By design, some patients will be above and others below these target concentrations to provide us with a fuller picture of the right dosing approach in this population since there is no obstructive gradient to guide titration.

As a reminder, this trial is not designed to show statistical significance. We plan to issue a press release detailing the topline results from the MAVERICK study during the fourth quarter. We will also pursue presentation of these data at medical scientific congresses next year.

The goal of MAVERICK is to provide us with the information we need to define protocol parameters for registration program in non-obstructive HCM. Among the secondary and exploratory endpoints will be an assessment of the effect of mavacamten on exercise capacity, as measured via peak VO2, changes in New York Heart Association functional class, diastolic and systolic function, as measured by echocardiography, plasma NT-proBNP levels, and symptoms and quality of life assessment measures.

I feel confident in their success of this study. The wealth of data generated from MAVERICK will be highly informative in designing the late stage studies of mavacamten that can support a non-obstructive HCM indication. Should mavacamten demonstrate the benefits we anticipate in improving symptoms and function in the non-HCM population, we believe that this effect will be driven by mavacamten's ability to positively improve diastolic filling.

This in turn will also provide our translational medicines team with more intelligence as to how to best tackle other diseases of diastolic compliance and relaxation. With no other therapeutics known to target improvements in relaxation and filling of the heart, the data from MAVERICK will give us tremendous insights into our ability to treat target populations with diastolic heart failure or HFpEF.

This is an incredibly exciting time at MyoKardia. As we look ahead to the data being generated from the PIONEER-OLE, MAVERICK, and EXPLORER trials in the upcoming months, not only to mention the significant forward strides being met by MYK-491 and 224 as well as our research pipeline. We look forward to keeping you informed all the way, the next stop being the ESC Congress coming up at the end of this month, where will present the 36-week data from the PIONEER-OLE data.

Taylor will now take us through the second quarter results.

Taylor Harris -- Chief Financial Officer

Thanks, Jay. Before discussing our second quarter results, I'll provide just a few highlights from our recent transaction with Sanofi, which accompanied the conclusion of our partnership. As part of the broader wind down process, we reached an agreement to acquire Sanofi's only remaining economic interest in MyoKardia, which was a royalty on US sales of mavacamten and MYK-224, which remains from 5% to 10% based on the annual sales volume.

In exchange for reclaiming this royalty interest, we made an initial payment of $50 million and will make a subsequent payment of $30 million, currently held in escrow in the middle of 2020. We're thrilled to have been able to consolidate global economic and commercial rights to our HCM franchise during 2019 and we believe the purchase price for this royalty stream represents a great deal from MyoKardia and our shareholders.

We're confident in the opportunity ahead of us, which is why we decided to increase our economic interest in the program and we're now positioned with full control and strategic optionality across our portfolio. In our third quarter financials, we plan to reflect the full $80 million consideration as an expense for P&L purposes and as a reduction of our balance of cash and investments.

Now, turning toward our second quarter 2019 financial results, total operating expenses were $41.6 million, including $27.7 million of R&D and $13.9 million of G&A expense. This reflects a year-over-year increase of approximately $15 million, driven by R&D spend, reflecting the advancement of mavacamten into late stage studies, including MAVERICK, EXPLORER, and MAVA-LTE.

In Q2, R&D expense was net of approximately $10 million of reimbursement from Sanofi. With the collaboration concluded, this will be our final quarter to recognize R&D credits related to the mavacamten program.

We ended the second quarter of 2019 with $602 million in cash and investments, which does not yet reflect the payments in association with the royalty buyback. We're fully funded to execute on all of our planned operational activities into the second half of 2021, more than a year past the expected topline data readout for explorer.

Included in our runway projection is the full registration program for mavacamten in obstructive HCM and the ability to aggressively advance our pipeline, including both MYK-491 and MYK-224, following anticipated positive milestones starting later this year.

So far in 2019, we've released six-month PIONEER-OLE data, we've completed enrollment in MAVERICK and screening in explorer, and in the months to come before 2019 draws to a close, we will have data from MAVERICK as well as additional longer-term data from PIONEER-OLE and data from the Phase 2A study of MYK-491, a lot of significant progress to look forward to.

So, with that, I'd now like to open up the call to your questions. As a reminder, here with me and Tassos are Dr. Jay Edelberg and Jake Bauer.

Questions and Answers:


Thank you. Ladies and gentlemen, if you have a question at this time, please press * then the 1 key on your touch tone telephone. If your question has been answered or you wish to remove yourself from the queue, you may press the # key. As a reminder, we ask that you please limit yourself to one question.

Our first question comes from the line of Martin Auster with Credit Suisse. Your line is now open.

Martin Auster -- Credit Suisse -- Managing Director

Hey, thanks, everybody. Congratulations on the progress over the last quarter, especially the royalty purchase from Sanofi. Tassos, you've spoken previously about there being fairly broad potential commercial pricing range for mavacamten, as you guys think about it. As we get closer to the EXPLORER data, the analyst community is starting to optimistically look forward to commercialization. I was wondering if you could update us on how you're thinking about pricing comps and what factors would cause you to swing toward the lower or higher end of the pricing range.

Then just in general, beyond exercised capacity improvements in EXPLORER, what data do you think will be seen as most valuable by clinicians and/or the payer communities in that data set? Thanks.

Tassos Gianakakos -- President and Chief Executive Officer

Hey, Marty. Thanks. It's early for us to really comment too much on pricing given where we are right now. It's a very dynamic context, as we all know. I think the main driver for us and what we're focused on is creating the evidence that is really going to illustrate to the ecosystem that this is valuable therapy. We're talking about introducing a product, the first one that's going to be targeting the underlying cause of disease and the disease area that is really one with inadequate options. So, we like that context, let's say, from a value standpoint.

The ranges for us outside of things out of our control are really going to be influenced by the data. So, looking at what our primary aim is at, symptom improvement and functional improvement, as you know, we are looking beyond that for the program in totality around disease modification, slowing down the modification of disease, potentially reversing the progression of disease -- these are things we've seen in preclinical models that are relevant to disease and we're starting to see in the open label extension. That's really exciting.

So, the more of that that we're going to be able to see and have the ability to really hang our hat on, I think, relatively, we'll see more value for the therapy as we're slowing down and potentially reversing what is a progressive disease that ultimately ends up taking a majority of these patients' life.


Thank you. Our next question comes from the line of Ritu Baral with Cowen. Your line is now open.

Dushat -- Cowen and Company -- Analyst

Hey, guys. This is Dushat sitting in for Ritu. Thank you so much for taking my question. One thing I've been kind of worrying about is thinking about this disease, a lot of these patients, the biggest thing is arrhythmia burden and risk of VT and sudden cardiac death. In your open label extension studies or even the EXPLORER trial, will you guys be exploring burden of arrhythmias or risk of non-sustained ventricular tachycardia or those kinds of measures as well.

Jay Edelberg -- Senior Vice President of Clinical Development

This is Jay. It's a great question. We'll be looking at the overall arrhythmic burden there with a range of different modalities. I think the thing that's the most promising that we see today is that reduction in the left atrial volume size that was reported in the OLE set and we'll continue to follow it out over the course of time. We know about the correlation of left atrial volume to AF burden. So, we're very, very excited about what we're seeing.


Thank you. Our next question comes from the line of Jim Birchenough with Wells Fargo. Your line is now open.

Jim Birchenough -- Wells Fargo -- Managing Director

Hi, guys. Congrats on all the progress. Question on MAVERICK and just expectations relative to what we saw out of the PIONEER study. I'm trying to understand if we should expect baseline characteristics to be similar in terms of baseline peak VO2 and New York Heart Association classification.

I just want to make sure that these are patients that have the potential to show similar benefit as we saw in PIONEER. Then in terms of expectations, are we just looking for correlations between either plasma exposure or echo parameters in some of those clinical endpoints? Thanks.

Tassos Gianakakos -- President and Chief Executive Officer

Hey, Jim. Yeah. So, the baseline characteristics between the PIONEER population and MAVERICK are very similar. We check those. Jay and his team are looking at those and they're similar. We can tell you that straight away.

This is an important study for us, MAVERICK. It's got two dimensions to it that for us are really exciting and have the potential to create value along the lines of expansion of mavacamten's potential use in the non-obstructive patients as well as starting to really give us strong evidence in a study constructed like this around improvements in diastole, which moves us into HFpEF and those areas, which, as we've touched on the prepared remarks, may be one of the biggest remaining unmet needs on the planet is helping folks that have diastolic dysfunction.

So, we're feeling very good about the study's design and enabling success. We expect it to be successful. Maybe Jay can tell us a little bit more about what success looks like in MAVERICK for you.

Jay Edelberg -- Senior Vice President of Clinical Development

Because this is a dose-ranging study, we're going to have patients at a range of different PKs. So, we're going to be looking for those patients who get the most benefit based on functional class, the symptomatic, moving the biomarkers, the echocardiogram, and to find the profile of response and the dose that led to that response, that's going to be what success is.


Thank you. Our next question comes from the line of Anupam Rama with JP Morgan. Your line is now open.

Tessa Romero -- JP Morgan -- Analyst

Hi, guys. This is Tessa filling in for Anupam. Congratulations on all the progress and thank you for taking our questions. Just one from us -- there is a view that perhaps a magnitude of benefit on VO2 and NYHA class in a non-obstructive population could be less than what we've seen in the obstructive HCM population, specifically less that what you observed in cohort A. How are you thinking about this? Can you just remind us again of how to be thinking about the placebo harm in Maverick and what would be kind of a win scenario there? Thanks so much, guys.

Jay Edelberg -- Senior Vice President of Clinical Development

So, when we're thinking about this, we know there's no gradient that we're going to be reducing, so, we're looking for the potential benefits on improving that diastolic component that's impaired in these patients with non-obstructive HCM. So, we're going to really focus on the totality of the data, in addition to the symptomatic and functional improvement that we hope to see, we're also going to be looking at those echo components in the plasma biomarkers to find that response. So, that's really where we're going to look. So, we want to see that totality at that right dose concentration.


Thank you. Our next question comes from the line of Jeff Hung with Morgan Stanley. Your line is now open.

Jeff Hung -- Morgan Stanley -- Analyst

Thanks for taking the question. What learnings have you had from mavacamten that you can apply in diastolic heart failure and can you remind us what preclinical data you're expecting by year end?

Tassos Gianakakos -- President and Chief Executive Officer

Hey, Jeff. Learnings from mavacamten that we can apply to diastolic dysfunction -- yeah, so, a couple of things that we know -- we're understanding the underlying disease pathophysiology, the mutations that cause the disease are the same, how it effects the hemodynamics and the physiology of the heart, we're really understanding very well a lot of our translational models and we're assessing that in our current and ongoing clinical studies with mavacamten.

That is a repository of data around diastolic compliance and function that we're bringing back to help us learn about mavacamten's effect on diastolic relaxation as well as the disease itself and how diastolic dysfunction factors into it. I would say those are really important insights that we're getting because we're in the studies that we're in and we're collecting all this information and have, of course, the data sets in hand.

In terms of non-clinical data that we plan on releasing between now and the end of the year, I know there's a lot that we are lining up for the remaining roster of medical conferences, the ESC as well as the AHA. So, be on the lookout for that and what we're planning on sharing there.


Thank you. Our next question comes from the line of Alethia Young with Cantor Fitzgerald. Your line is now open.

Emma -- Cantor Fitzgerald -- Analyst

Hi, this is Emma on for Alethia. For 491, I believe we saw increases of cardiac contractility is around 5% to 20% at the higher exposures in Phase 1. I'm just wondering if you could provide a potential range around what we can find in the Phase 2 and also any key safety metrics that we should be looking at when we're increasing contractility?

Tassos Gianakakos -- President and Chief Executive Officer

Yeah, you bet, Emma. 491 is a valuable drug candidate and asset for us that you'll be hearing more and more about. We haven't talked a whole lot about it so far given all the great progress we want to update on mavacamten, but toward the end of this year, you're going to get data from our ongoing Phase 2 study and a little bit more about our intended plans to advance the program into targeted segments where we think there's a lot of opportunity.

Here, we're talking about patients that have impaired systolic function. There are several targeted subsets that we're keying in on and we'll share more of how we plan to pursue creating value for patients on that as we release data later this year.

You've accurately characterized the data that we find encouraging from Phase 1. We're seeing improvements in stroke volume and importantly, what we think gives 491 best-in-class potential in myosin activation is the fact that we're able to -- we're seeing so far, we've designed a molecule to increase cardiac output, stroke volume contractility without impairing diastole. That's really important.

So, that is a signature feature of 491's mechanism. We'll be sharing information around diastolic function while we share the data you've referenced that speaks to improvements in systolic function as well.


Thank you. Our next question comes from the line of Gobind Singh with BMO Capital Markets. Your line is now open.

Gobind Singh -- BMO Capital Markets -- Analyst

Hi, guys. Congrats on another quarter. This is Gobind on for George Farmer. Two questions -- was the royalty buyback from Sanofi a competitive process and if so, maybe you can just share any details, how many parties, anything along those lines. The second question was there any reason why the patient enrollment was increased in EXPLORER and how are those patients going to be treated in the primary/secondary analyses? Thank you.

Tassos Gianakakos -- President and Chief Executive Officer

Yeah. Jake is on the line and we'll have him answer in a second the royalty question and maybe Jay, a little bit about the enrollment exceeds.

Jay Edelberg -- Senior Vice President of Clinical Development

So, the enrollment was really quite robust and so many patients came into screening at the end of the trial that we wanted to make sure all patients who entered screening were given the opportunity to enroll. We'll be able to handle those as part of the overall protocol and they'll be handled as we would in the primary and secondary endpoints without any difficulty.

Tassos Gianakakos -- President and Chief Executive Officer

I think some of that acceleration of the timing of the numbers in patients and screening really underscores the enthusiasm that's out there from the community. The investigators in particular are very hopeful for any therapy, the patients are there at the clinical sites. So, for us, it's gratifying to see that translate into more patient numbers and accelerated timeframe from the study.

Jake Bauer -- Chief Business Officer

Yeah, on the royalty, we're excited to receive the full rights back. We feel we've captured value in the transaction. With respect to process, I'm not sure how competitive it was. We tried to act quick when we found out Sanofi was willing to monetize that asset. We do believe there was another bidder, but we moved quickly before there was a broad competitive process.

Gobind Singh -- BMO Capital Markets -- Analyst

Thank you. Very helpful.


Thank you. Our next question comes from the line of Mohit Bansal with Citigroup. Your line is now open.

Mohit Bansal -- Citigroup -- Analyst

Thanks for taking my question and congrats on all the progress. I'm just wondering -- on non-obstructive trial, you have discussed in the past that CV compliance is going to be a key part of why mavacamten might work there. Based on your pre-clinical work, do you think the amount of CV compliance we are assessing here would be enough to show a benefit in the timeframe we are looking at in the MAVERICK trial? Thank you.

Tassos Gianakakos -- President and Chief Executive Officer

So, I think the most compelling data we should look at is actually the data from the PIONEER-OLE. From the OLE, we're seeing improvements in both plasma and echo biomarkers even after the gradient has been relieved. So, especially that reduction in LA volume size even after the gradients have been reduced is a good indirect indicator of the potential benefits in diastole. We would expect that should they share the same genetic predisposition, we would hope those would be able to translate into the patients who never had an obstruction with non-obstructive HCM.


Thank you. I'm showing no further questions at this time. With that, I'll turn the call back over to CEO Tassos Gianakakos for closing remarks.

Tassos Gianakakos -- President and Chief Executive Officer

Thanks a lot, Andrew. This is such an interesting point in time for MyoKardia. We are incredibly energized, as you can imagine, about all the opportunities we have before us to make a meaningful difference in the lives of people with serious cardiovascular disease, starting with HCM. Now, we're less than a year away from pivotal Phase 3 data from mavacamten. We're gearing up for the regulatory process and potential commercial launch.

Between now and topline data in the second quarter of next year, we expect to build further value through the two important Phase 2 study readouts we've talked about today for 491 and in non-obstructive with MAVERICK. I look forward to keeping you updated on the progress across our portfolio and hope to see many of you over the next month or so as we participate in several of the upcoming investor and medical conferences.

Thanks to everyone for your time today and your continued support of MyoKardia and our mission.


Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may all disconnect. Everyone have a wonderful day.

Duration: 34 minutes

Call participants:

Michelle Corral -- Head of Communications and Investor Relations 

Tassos Gianakakos -- President and Chief Executive Officer

Jay Edelberg -- Senior Vice President of Clinical Development

Taylor Harris -- Chief Financial Officer

Jake Bauer -- Chief Business Officer

Martin Auster -- Credit Suisse -- Managing Director

Dushat -- Cowen and Company -- Analyst

Jim Birchenough -- Wells Fargo -- Managing Director

Tessa Romero -- JP Morgan -- Analyst

Jeff Hung -- Morgan Stanley -- Analyst

Emma -- Cantor Fitzgerald -- Analyst

Gobind Singh -- BMO Capital Markets -- Analyst

Mohit Bansal -- Citigroup -- Analyst

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