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Edited Transcript of MYOK earnings conference call or presentation 7-Aug-19 8:30pm GMT

Q2 2019 MyoKardia Inc Earnings Call

SOUTH SAN FRANCISCO Aug 14, 2019 (Thomson StreetEvents) -- Edited Transcript of MyoKardia Inc earnings conference call or presentation Wednesday, August 7, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Jake B. Bauer

MyoKardia, Inc. - Chief Business Officer

* Jay Edelberg

MyoKardia, Inc. - SVP of Clinical Development

* Michelle Corral

MyoKardia, Inc. - Senior Director of Corporate Communications & IR

* Tassos Anastasios Gianakakos

MyoKardia, Inc. - President, CEO & Director

* Taylor C. Harris

MyoKardia, Inc. - CFO

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Conference Call Participants

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* Emma Kathleen Nealon

Cantor Fitzgerald & Co., Research Division - Analyst

* Gobind Singh

BMO Capital Markets Equity Research - Biotechnology Equity Research

* James William Birchenough

Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst

* Jeff Hung

Morgan Stanley, Research Division - Equity Analyst

* Martin Douglas Auster

Crédit Suisse AG, Research Division - Research Analyst

* Mohit Bansal

Citigroup Inc, Research Division - VP and Analyst

* Tessa Thomas Romero

JP Morgan Chase & Co, Research Division - Associate

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Presentation

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Operator [1]

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Good day, ladies and gentlemen, and welcome to MyoKardia's Second Quarter 2019 Financial Results Conference Call. (Operator Instructions) As a reminder, this call is being recorded.

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

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Michelle Corral, MyoKardia, Inc. - Senior Director of Corporate Communications & IR [2]

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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. (Operator Instructions)

As a reminder, the information discussed during this call will include forward-looking statements, which represent the company's view as of today, August 7, 2019. We undertake no obligation to update or revise any forward-looking statement 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?

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Tassos Anastasios Gianakakos, MyoKardia, Inc. - President, CEO & Director [3]

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Thanks, Michelle. Good afternoon, everyone, and thanks for joining us today. MyoKardia's 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 sharpened the time line for a 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 to the potential introduction of the first-ever targeted therapy for HCM.

HCM is a progressive disease that affects over 600,000 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 a 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. And 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. And 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 top line data release 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 timing. 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 top line results, we've got multiple derisking and value-creating datasets 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 Cardiology 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 in important biomarkers that correlate to improved outcomes, including NT-proBNP, LA volume index and E/e' prime. Similar results over the 36- and 48-week time frame would further increase our confidence in mavacamten and a successful EXPLORER study.

Looking at nonobstructive HCM, mavacamten's second indication and a very important one for MyoKardia, we announced completion of enrollment in the Phase II MAVERICK study in May and are on track to release top line 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 in nonobstructive 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 possesses 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 II 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 I result 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 II 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?

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Jay Edelberg, MyoKardia, Inc. - SVP of Clinical Development [4]

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Well, thanks, Tassos, and 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 a 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 and 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 been met and matched with a remarkable level of enthusiasm and commitment amongst the clinical investigators and their staff. Having spent time visiting many of the sites myself, I can attest to the excitement amongst 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 end points, including New York Heart Association Classification and peak VO2, which make up the components of the primary clinical response end point as well as serving a stand-alone secondary end point. These end points 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 end points was directly informed by our learnings from the Phase II PIONEER-HCM study.

Nonobstructive HCM is driven by the same genetic mutations as obstructive HCM. In both cases, these mutations result in the formation of excessive myosin-actin cross-bridges in the sarcomere, the result in thickening of the heart. In nonobstructive disease, this thickness occurs lower in the left ventricle. And symptoms of disease are driven by the lack of compliance of the left ventricle during diastole. Data from our clinical and preclinical studies of mavacamten also give us reason to believe that it will have a positive effect on patients with nonobstructive HCM. The most recent example comes from the PIONEER-OLE dataset 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 end points, including NT-proBNP and left atrial volume size. These were not directly linked to the gradient and, therefore, may be indicators of long-term benefit.

The MAVERICK Phase II trial is one of the first and largest randomized clinical trials in patients with nonobstructive hypertrophic cardiomyopathy. MAVERICK is a dose-ranging study with the primary end point of safety and tolerability. Patients in MAVERICK have been assigned to 1 of 3 groups to receive once-daily doses of mavacamten targeting 2 dose concentrations, centergram 200 and 500 nanograms per mil 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 grading to guide titration. As a reminder, this trial is not designed to show statistical significance. We plan to issue a press release detailing the top line results from the MAVERICK study during the fourth quarter. We will also pursue presentation of these data to medical scientific congresses next year.

The goal of MAVERICK is to provide us with the information we need to define protocol parameters for a registration program in nonobstructive HCM. Among the secondary and exploratory end points 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 the 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 nonobstructive 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. And the next stop being the ESC Congress coming up at the end of this month, where we will present the 36-weeks' data from the PIONEER-OLE data.

Finally, Taylor will now take us through the fourth quarter results -- second quarter.

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Taylor C. Harris, MyoKardia, Inc. - CFO [5]

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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 U.S. sales of mavacamten and MYK-224, which ranged from 5% to 10% based on an 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 that the purchase price for this royalty stream represents a great deal for 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 top line 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 released 6-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 IIa 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.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from the line of Martin Auster with Crédit Suisse.

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Martin Douglas Auster, Crédit Suisse AG, Research Division - Research Analyst [2]

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Congratulations on the progress over the last quarter, especially the royalty purchase from Sanofi. Tassos, you've spoken previously about there being a 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 kind of optimistically look forward to commercialization. And I was wondering if you could update us on how you're thinking about pricing comps. And what factors would cause you to swing towards the lower or higher end of the pricing range? And then just in general, beyond exercise capacity improvements in EXPLORER, what data do you think will be seen as most valuable by clinicians and/or impaired communities in that data set?

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Tassos Anastasios Gianakakos, MyoKardia, Inc. - President, CEO & Director [3]

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Marty, yes, thanks. The -- early for us to really comment too much on pricing, given where we are right now. 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 going to really illustrate to the ecosystem that this is a valuable therapy. We're talking about introducing a product, the first one that's going to be targeting the underlying cause of disease in 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 aims 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 progression 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. So 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.

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Operator [4]

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And our next question comes from the line of Ritu Baral with Cowen.

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Unidentified Analyst, [5]

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This is [Dushant] sitting in for Ritu. One thing I've been kind of wondering about is just in the -- thinking about the [bout of physiology to] this disease. A lot of these patients, the biggest thing is kind of arrhythmia burden and risk of VP and sudden cardiac death. In your open-label extension studies or even in the EXPLORER trial, will you guys be exploring kind of burden of arrhythmias or risk of like nonsustained ventricular tachycardia, those kind of measures as well?

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Jay Edelberg, MyoKardia, Inc. - SVP of Clinical Development [6]

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

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Operator [7]

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And our next question comes from the line of Jim Birchenough with Wells Fargo.

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James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [8]

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Congrats on all the progress. Question on MAVERICK and just expectations relative to what we saw out of the PIONEER study. Trying to understand if we should expect baseline characteristics to be similar in terms of baseline peak VO2 and New York Heart Association Classification. Just want to make sure that these are patients that have the potential to show similar benefit as we saw in PIONEER. And then in terms of expectations, are we just looking for correlations between either plasma exposure or echo parameters and some of those clinical end points?

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Tassos Anastasios Gianakakos, MyoKardia, Inc. - President, CEO & Director [9]

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Jim, yes. So the baseline characteristics between the PIONEER population and MAVERICK are very similar. We check those. Jay and his team here 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 2 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 nonobstructive 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 in the prepared remarks, maybe 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. And maybe Jay can tell us a little bit more about what success looks like in MAVERICK for you.

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Jay Edelberg, MyoKardia, Inc. - SVP of Clinical Development [10]

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Because this is a dose-ranging study, we're going to have patients at a range of different PK. So we're going to be looking for those patients who get the most benefit based on the functional class, the symptomatic, the move in 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.

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Operator [11]

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And our next question comes from the line of Anupam Rama with JPMorgan.

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Tessa Thomas Romero, JP Morgan Chase & Co, Research Division - Associate [12]

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This is Tessa filling in for Anupam. Congratulations from us on all the progress. Just one from us. There is a view that perhaps the magnitude of benefit on VO2 and NYHA Class in a nonobstructive population could be less than what we've seen in the obstructive HCM population, specifically less than what you observed in Cohort A. How are you thinking about this? And can you just remind us again of how to be thinking about the placebo arm in MAVERICK? And what would be kind of a win scenario there?

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Jay Edelberg, MyoKardia, Inc. - SVP of Clinical Development [13]

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So when we're thinking about this, we know that 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 nonobstructive 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, also going to be looking at those echo components and the plasma biomarkers to find that response. So that's really where we're going to look. And so we want to see that totality at that right dose concentration.

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Operator [14]

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And our next question comes from the line of Jeff Hung with Morgan Stanley.

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Jeff Hung, Morgan Stanley, Research Division - Equity Analyst [15]

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For LUS-1, 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?

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Tassos Anastasios Gianakakos, MyoKardia, Inc. - President, CEO & Director [16]

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Jeff, learnings from mavacamten that we can apply to diastolic dysfunction. Yes. So a couple of things that we know. We're understanding the underlying disease pathophysiology, the mutations that caused the disease are the same, how it affects the hemodynamics and the physiology of the heart. We're really understanding very, very well in a lot of our translational models, and we're assessing that in our current and ongoing clinical studies with mavacamten. So that is a repository of data around diastolic compliance and function that we're bringing back to help us really learn about mavacamten's effect in -- on diastolic relaxation as well as the disease itself and how diastolic dysfunction factors into it. So I would say that is -- 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 nonclinical data that we plan on releasing between now and the end of the year, I know we're -- 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.

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Operator [17]

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And our next question comes from the line of Alethia Young with Cantor Fitzgerald.

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Emma Kathleen Nealon, Cantor Fitzgerald & Co., Research Division - Analyst [18]

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This is Emma on for Alethia. For 491, I believe we saw increases of cardiac contractility of around 5% to 20% at the higher exposures in Phase I. So just wondering if you could provide any context around the potential range of what we could see in the Phase II. And then also any key safety metrics that we should be looking at when we're increasing contractility.

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Tassos Anastasios Gianakakos, MyoKardia, Inc. - President, CEO & Director [19]

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Yes, you bet, Emma. So the 491 is a valuable, valuable drug candidate and asset for us that you'll be hearing more and more from us about. We haven't talked a whole lot about it so far given all the great progress that we want to update on mavacamten. But towards the end of this year, you're going to get data from our ongoing Phase II 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. We think here, we're talking about patients that have impaired systolic function. There are several targeted subsets that we're keyed 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 I. 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. And that's really important. So that is a signature feature of 491's mechanism. So we'll be sharing then information around the diastolic function while we share the data like the data you've referenced that speaks to improvements in systolic function as well.

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Operator [20]

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And our next question comes from the line of Gobind Singh with BMO Capital Markets.

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Gobind Singh, BMO Capital Markets Equity Research - Biotechnology Equity Research [21]

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Congrats on another quarter. This is Gobind on for George Farmer. Just 2 questions. Was the royalty buyback from Sanofi a competitive process? And if so maybe you could just share any details. How many parties? Anything along those lines? And then the second question was, 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?

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Tassos Anastasios Gianakakos, MyoKardia, Inc. - President, CEO & Director [22]

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Yes. So 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.

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Jay Edelberg, MyoKardia, Inc. - SVP of Clinical Development [23]

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

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Tassos Anastasios Gianakakos, MyoKardia, Inc. - President, CEO & Director [24]

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And a lot of the -- I think some of that acceleration of the timing and the numbers in patients in screening, I think really underscores the enthusiasm that's out there from the community. The investigators, in particular, are very hopeful for a new therapy. The patients are there at the clinical sites. And so for us, it's gratifying to see that translate into more patient numbers in an accelerated time frame from the study.

Jake, maybe hand it over to you.

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Jake B. Bauer, MyoKardia, Inc. - Chief Business Officer [25]

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Yes, on the royalty, we're excited to receive the full rights back. We feel we've captured value in the transaction. And with respect to process, 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.

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Operator [26]

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And our next question comes from the line of Mohit Bansal with Citigroup.

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Mohit Bansal, Citigroup Inc, Research Division - VP and Analyst [27]

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Congrats on all the progress from my end as well. Just wondering, so on nonobstructive trial, you have discussed in the past that CV compliance is going to be a key part of why mavacamten might work there. So based on your preclinical work, do you think the amount of CV compliance we are witnessing here would be enough to show a benefit in the time frame we are looking at in the MAVERICK trial?

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Jay Edelberg, MyoKardia, Inc. - SVP of Clinical Development [28]

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So I think the most compelling data that we should look at is actually the data from the PIONEER-OLE. In the OLE, we see that -- 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. And so we would expect that since they share the same genetic predisposition, that we would hope that those would be able to translate into the patients who never had an obstruction with nonobstructive HCM.

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Operator [29]

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

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Tassos Anastasios Gianakakos, MyoKardia, Inc. - President, CEO & Director [30]

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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 less than a year away from pivotal Phase III data from mavacamten, we're gearing up for the regulatory process and potential commercial launch. In between now and top line data in the second quarter of next year, we expect to build further value through the 2 important Phase II study readouts we've talked about today for 491 and in nonobstructive with MAVERICK.

So 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 for your continued support of MyoKardia and our mission.

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Operator [31]

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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.