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Atea Pharmaceuticals Inc (AVIR) Q2 2021 Earnings Call Transcript

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AVIR earnings call for the period ending June 30, 2021.

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Atea Pharmaceuticals Inc (AVIR -1.50%)
Q2 2021 Earnings Call
Aug 12, 2021, 4:30 p.m. ET


  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Good afternoon, ladies and gentlemen. Welcome to Atea Pharmaceuticals second-quarter 2021 financial results conference call. [Operator instructions] I would now like to turn the call over to Jonae Barnes, senior vice president of investor relations and corporate communications at Atea Pharmaceuticals. Please proceed.

Jonae Barnes -- Senior Vice President of Investor Relations and Corporate Communications

Thank you, operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals second-quarter 2021 financial results conference call. This afternoon, we issued a press release, which outlines the topics that we plan to discuss. You can access the press release as well as the slides that we'll be reviewing today by going to the investors section of our website at

With me today from Atea, our founder, chairman, and chief executive officer, Dr. Jean-Pierre Sommadossi; chief development officer, Dr. Janet Hammond; chief financial officer, executive vice president of legal, Andrea Corcoran; and our chief commercial officer, John Vavricka. They will all be available for the Q&A portion of today's call.

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On the call today, we have a lot of important content to review. Jean-Pierre will provide an overview on the current COVID-19 environment and AT-527's potential to address these key challenges. Janet will review our clinical progress and results for AT-527 for the treatment of COVID and discuss AT-752 for the treatment of dengue fever. John will then provide an overview of the U.S.

commercial opportunities for AT-527, Andrea will provide a financial update, and Jean-Pierre will provide closing remarks. Before we begin the call, I would like to remind you that today's discussion will contain forward-looking statements that involve risk and securities. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we encourage you to read. Our actual results may differ materially from what is discussed on today's call.

With that, I'll now turn the call over to Jean-Pierre.

Jean-Pierre Sommadossi -- Founder, Chairman, and Chief Executive Officer

Thank you, Jonae. Good afternoon, everyone, and thank you for joining us today. I will begin on Slide 3 of the presentation. Since Atea founding, we have remained steadfast in our mission to discover and develop antiviral drugs for the treatment cure and prophylaxis of severe viral diseases, where there is a significant unmet medical need where we can make a meaningful impact for patients.

Early last year, our antiviral platform put us at the forefront in the fight against COVID-19. And we believe a multipronged approach, including therapeutics and vaccine, will be essential solutions in this pandemic, which is now becoming endemic. It has become abundantly clear that most countries and regions like Southeast Asia, South America and India, where we are seeing a devastating impact from COVID of low vaccination rates which have become a source for variants and create new challenges for treatment and prevention. It is projected that the Delta variant currently account for 93% of all new cases in the United States and we are now back to 100,000 new infections per day.

Obviously, this is a particular concern, given recent publication demonstrating lower efficacy rates for vaccine against the new strain. For example, the Delta variant has also been reported to be highly contagious, almost as contagious as chickenpox, and it has a more rapid replication than earlier strengths. And for this, we are seeing a significant number of breakthrough cases in fully vaccinated patients, accounting for as much as 15% in all hospitalized patients. And even 15% of the new cases now are in children, which further expands the infected population.

In addition to the Delta variant, the Lambda variant, first identified in Peru and now spreading in South America, is highly infectious as well. And particularly concerning, and I'm sure that in six months or so, we will probably talk about another dominant variant in the U.S. and other countries. Turning to Slide 4.

Given this evolving dynamics, medical intervention at all therapeutics in particular will be essential in stemming the tide of this pandemic. We believe that AT-527, our poly administered direct-acting antiviral agent derived from our purine nucleotide prodrug platform is uniquely positioned to help meet this challenge and become a solution. As I'm sure by now, you know, AT-527 targets viral RNA polymerase, which is a highly concerned enzyme critical to viral application and transcription. And with its dual mechanism affecting both functional domains, so this RNA polymerase inhibiting both NiRAN and the RdRp, we believe that we provide a high barrier to resistance, along with broad antiviral coverage for different variants of SARS-CoV-2.

To date, the predominant mutation actually in this RNA polymerase is the P323L. And please note a baseline in our hospitalized Phase II trials, 98% of the patients have this mutation. And we believe that all responded to AT-527 treatment. Essentially, we can say today that the original one viruses is basically gone.

And we believe that this bodes very well for antiviral activity against the variants as well, and we are currently validating this hypothesis. As reported in recent press releases, a significant amount of comparing clinical data has been reported for our drugs, demonstrating antiviral efficacy in our Phase II study in hospitalized patients. And today, Janet will review the Phase II interim results as well as new data on Bronchoalveolar Lavage study, demonstrating that AT-527, we believe, is the first investigational DAA being developed for COVID-19 and showing that target drug levels effectively reach the lung, which, as you know, is the primary site of SARS-CoV-2 infection. I want to emphasize that this is the lower respiratory track in contrast where we are measuring the RNA as Janet will show you and share with you the data we are talking about upper respiratory track.

So that's why we view this data as very important for our development program as they provide further confidence, not only for the treatment, but also for our planned prophylaxis studies for COVID-19. As we continue to advance multiple global clinical studies in parallel with our partner, Roche, we are one step closer to achieving our goal of providing an easily administered or direct-acting antiviral in the fight against this global pandemic. And now I would like to turn the call to Janet for a full review of this data. Janet?

Janet Hammond -- Chief Development Officer

Thank you, Jean-Pierre. I will begin with Slide 6. As the COVID-19 pandemic evolves, and we generate more data from our AT-527 program, we are acting nimbly to optimizing the design and conduct of our clinical development program. As you can see here, we have six studies of AT-527 currently running in parallel.

And we're leveraging lessons learned from each study to better serve our patients and improve our probability of success. Slide 7 outlines our global Phase II study of AT-527 in the hospitalized setting. Before we review the interim results, as a reminder, this is a randomized, double-blind, placebo-controlled multicenter study to evaluate AT-527 in patients with moderate COVID-19. Study objectives are to assess safety, tolerability, clinical and antiviral efficacy.

We are currently amending the protocol to reflect the evolving COVID environment by changing the primary endpoint of virology, from its former progression to respiratory insufficiency going to the limited number of cases that now progressed due to changes in the standard of care. We will also be exploring alternative doses and adding a part B cohort comprised of up to 110 patients. Moving to Slide 8. In June, we were delighted to announce positive interim results from our global Phase II study of AT-527, indicating rapid and sustained antiviral activity against SARS-CoV-2 in patients with COVID-19 in the hospitalized setting.

The interim analysis of the Phase II study included data from 70 hospitalized high-risk patients with COVID-19, from which 62 patients were evaluable for virological analysis. These patients were infected with a broad array of virus lineages, representing over 20 variants and included the Alpha and Beta variance of concern. They were enrolled from seven countries in North America, Europe, Africa and South America, representing a diverse geographic footprint. 46% of patients with SARS-CoV-2 seropositive by IGM measurement at baseline and were equally distributed across the treatment arms.

As expected and observed in other studies, seropositive patients had lower baseline viral load. Continued viral load decline from the onset of respiratory tract infection is part of the natural history of these diseases and is to be expected. What is important is the differential rate of decline of virus driven by the administration of a direct-acting antiviral. The lower of the viral load, the lower the risk of transmitting infection and the greater the likelihood that the immune system is able to deal with whatever remaining virus is present and help to shorten and attenuate the disease.

On Slide 9, in all evaluable patients at Day 2, patients receiving AT-527 experienced a 0.7 log10 drop in viral load, which is an 8% greater mean reduction from baseline viral load in comparison with the placebo group. A sustained difference in viral load reduction between the two cohorts was maintained all the way through Day 8. With the state of it, we are seeing a rapid and strong antiviral signal, and this is critical as the value and immediate health impact of the DAA is to rapidly inhibit viral replication in the early phase of infection and reduced disease progression. AT-527 SARS-CoV-2 potent antiviral activity was consistent across multiple prespecified analysis.

And again, as expected, on Slide 10, was more pronounced in subjects enrolling with higher viral loads. On Slide 11, as measured by nasopharyngeal swabs in an RT-PCR test with a lower level of quantification of less than 500 copies, you can see in the graph to the left as early as day two and at day 10, 42% of the patients in the AT-527 arm achieved viral clearance compared with 0% in the placebo arm. In the graph to the right, when evaluating a stricter threshold with no detectable RNA virus or target non-detected TND, still 33% of patients in the AT-527 arm had undetectable RNA at Day 10. Earlier PCR negativity, as demonstrated in these Phase II results, may lead to a faster recovery time while also minimizing the transmission of infection.

In this Phase II study, consistent with previous studies, AT-527 was generally safe and well tolerated, and there were no drug-related serious adverse events. Now moving to Slide 12. You'll find new results here that evaluated drug levels measured in the lung lining fluid, and this is called a Bronchoalveolar Lavage study and measures drug levels from the surface of the lung and from cells in the lungs obtained through washings obtained from the lungs. For the first time with the direct-acting antiviral, target drug levels were achieved in the lungs in healthy volunteers with AT-527 550 milligrams administered twice daily.

And these levels even exceeded the target 0.5 micromolar or 150 nanograms per milliliter, which corresponds to the in vitro EC90 of the drug in infected primary human airway epithelial cells. This is important in confirming that AT-527 reaches target drug levels at the primary site of infection and has significant implications for efficacy in both treatment and prophylaxis for COVID-19. As seen on Slide 13, analysis of SARS-CoV-2-infected cells treated with AT-511, which is the free base of AT-527 by next-generation sequencing, confirmed that AT-527 is not a mutagen, and it does not introduce mutations into the viral genome. Such mutations, we believe, could be the catalyst for new variants, especially in immunocompromised patients.

In addition, a new drug-drug interaction study in healthy volunteers indicates that AT-527 is a weak inhibitor of CYP3A and that no dose adjustments should be needed for co-administration of drugs that are CYP3A substrate. CYP3As are the most abandoned cytochromes in the human liver, and are accountable for the metabolism of more than 50% of clinical drugs. So this should make prescribing simpler. Moving to Slide 14.

MOONSONG, our global Phase II trial of AT-527 in the outpatient setting, continues to advance. It's a randomized, double-blind, multi-center, placebo-controlled trial evaluating AT-527 in mild or moderate COVID-19 outpatients. It's being conducted in collaboration with Roche, and will enroll up to 220 patients to evaluate the antiviral activity, safety and pharmacokinetics of AT-527 in adult patients. The primary endpoint of this trial is change from baseline in the amount of SARS-CoV-2 virus RNA as measured by reverse transcription polymerase chain reaction at specified time point.

There are multiple cohorts with varying doses, and we expect results in the second half of this year, either late Q3 or early Q4. Enrollment in COVID-19 studies is challenging across the industry and we're continuing to open additional clinical sites, which is helping with recruitment. This is a surprisingly challenging disease for clinical trials in that its spread around the world is unpredictable, seemingly without seasonality. And when patients do become infected, there is a very limited window for eligibility for entry into our studies.

Next, this is a Phase II proof-of-concept study to show antiviral activity, supportive data for dosage and importantly, to confirm the safety profile of the drug. This study has not been powered for statistical significance. As highlighted on Slide 15, we continue to advance our Phase III MORNINGSKY trial, a global multi-center trial evaluating AT-527 in mild or moderate COVID-19 patients in an outpatient setting. This trial is being conducted with our partner, Roche, and it is currently enrolling patients outside of the United States.

We anticipate that it will enroll approximately 1,400 adults and adolescents with mild to moderate COVID-19. Patients with or without risk presses will be randomized within five days of symptom onset. At the time of enrollment, patients must be stable and not for hospitalization. The primary endpoint, evaluating the efficacy of AT-527 compared with placebo will measure the time to alleviation or improvement of COVID-19 symptoms.

Other key efficacy endpoints will include the number of patients acquiring medically attended visits or hospitalization for COVID-19 and also mortality. Additionally, among other secondary and exploratory endpoints, the study will also identify and/or evaluate biomarkers that are predictive of an antiviral response to AT-527. We currently expect results from the study in the second half of 2021. Patients from this study have the option to roll over into MEADOWSPRING, a Phase III six month-long term follow-on study conducted in collaboration with Roche.

This trial was recently initiated and will evaluate the impact of AT-527 on long COVID. It's expected to enroll approximately 1,000 patients and is already currently accruing patients. Let me now turn the call over to John for an AT-527 commercial update. John?

John Vavricka -- Chief Commercial Officer

Thank you, Janet. Turning to Slide 17. We tend to view the target population as four broad patient segments. There is symptomatic active disease in which a patient with symptoms would present and be treated.

There's asymptomatic active disease, and although they're asymptomatic, we believe these patients will be accessed through proactive testing from employers, schools and travel. And the third area is prophylaxis, both pre and post exposure; and finally, a government purchase, which would include purchases, both for active disease as well as for stockpile. And we see all of these segments have large market opportunity. We also consider it important to look at vaccinated and unvaccinated people in each of these segments when considering different patient motivations and communication needs.

Compared to the last pandemic with H1N1 in 2009, one of the biggest differences was that there were FDA-approved antivirals readily available so that the government chose to stockpile during the pandemic. Current government efforts appear to target availability of new oral therapeutic treatments for COVID-19 and are meant for immediate utilization within the U.S. distribution system following an EUA or an NDA approval. There is currently a $3.2 billion government offering from oral therapeutic treatments for high-risk outpatients, mild to moderate patients and pre- and post-exposure prophylaxis treatment, and we remain in active discussions with the U.S.

government agencies regarding this offering. We also believe that given the devastating global impact of COVID-19, it is highly likely that the U.S. government will also stockpile treatments for future preparedness, similar to what they stockpiled during H1N1. With that overview, I'll now turn the call back over to Janet.

Janet Hammond -- Chief Development Officer

Thanks, John. On Slide 19, I'm pleased to report that we are also making progress with AT-752, our program for dengue. The Phase Ia single ascending-dose study portion of the trial, evaluating multiple doses have been successfully completed and the multiple ascending dose portion of the trial was initiated during this quarter. The objective of the study is to establish the safety and tolerability of AT-752 and also to support dose selection for future studies of AT-752 as a treatment and also for prophylaxis of dengue fever.

It's expected to roll up to 60 patients. With that, I'll now turn the call over to Andrea for a review of the financials.

Andrea Corcoran -- Chief Financial Officer, Executive Vice President of Legal

Thank you, Janet. As John mentioned in her introductory remarks, this afternoon, we issued a press release containing our financial results for the second quarter of 2021. The statement of operations and balance sheet are on slides 21 and 22. For the second quarter 2021, the increase in research and development expenses, in comparison to the second quarter of 2020, was principally driven by an increase in external clinical development and manufacturing expenses incurred primarily in conjunction with the advancement of AT-527 for the treatment of COVID-19 and, to a lesser extent, AT-752, which is being developed for dengue fever.

These expenses included our share of costs incurred by Roche and increases in internal spend, mostly due to an increase in personnel-related expenses. The increase in general and administrative expenses was primarily due to the expansion of our organization and consists principally an increase in payroll and personnel-related expenses. I am pleased to report that we ended the second quarter with a strong balance sheet to support our clinical development programs. As of June 30, 2021, cash and cash equivalents were $816.5 million.

Please note that this does not include the $50 million development milestone the company achieved in June under our license agreement with Roche. That payment was received in July. I'll now turn the call back over to Jean-Pierre for closing remarks.

Jean-Pierre Sommadossi -- Founder, Chairman, and Chief Executive Officer

Thank you, Andrea. In closing, we cannot underestimate the importance of the AT-527 clinical development program and the progress we are making. The COVID-19 endemic remained very much with us and all data points to another surge this fall due to the Delta variants and low vaccination rates around the world. It is our goal to advance this important program and to provide rapidly a solution that can play an important role in helping to reduce the global burden of this disease.

The Atea team, along with our partners at Roche, are doing everything in our power to make this happen. Our success would be everyone's success. As reviewed today, we continue to make substantial progress with AT-527. And now we have demonstrated that AT-527 has rapid and sustained antiviral activity against SARS-CoV-2, reaches target drug level in the lung, which, as you know, is the primary site of infection; a unique dual mechanism, targeting the RNA polymerase, which we believe will be important for high barrier to resistance and hopefully also for addressing the problem that we are seeing with the variants.

Demonstrated that it is not a mutagen, very likely not leading to new variants in the future and no dose adjustment necessary for co-administration of drugs that are substrate, as you know, and Janet has indicated, are the largest majority of drug being metabolized by these enzymes. As we continue to advance multiple global clinical studies in parallel with our partner, Roche, we look forward to the upcoming results from the Phase II MOONSONG and the Phase III MORNINGSKY studies. In addition to the substantial progress with AT-527, we continue to make progress with the other drug candidates in our antiviral pipeline for the treatment of dengue, hepatitis C and RSV, and we expect to provide an update on these programs later this year. With that, operator, we will now open the call to your questions.

Questions & Answers:


[Operator instructions] And your first question comes from the line of Eric Joseph with J.P. Morgan.

Eric Joseph -- J.P. Morgan -- Analyst

Hi. Good evening. Thanks for taking my questions. A couple from us.

I guess, first, as it relates to the Phase II inpatient data, I'm curious to know whether at this stage, whether the field kind of has a sense of how the normal decay of viral load mirrors onto symptom improvement or symptom resolution? I guess, if we're trying to relate the comparative viral load data in the Phase II study, is there sort of an absolute threshold of viral load that might predict for a symptom resolution? Or is kind of a goal trying to get to viral clearance and as great a proportion of patients as possible? And then secondly, JP, you highlighted the unmet need in the pediatric population. I'd be curious to know whether there are any plans to kind of begin safety testing in a pediatric population to kind of expand access to that opportunity?

Jean-Pierre Sommadossi -- Founder, Chairman, and Chief Executive Officer

Two great questions, Eric. Thank you. Janet, can you maybe address both questions?

Janet Hammond -- Chief Development Officer

Thank you, Jean-Pierre. Yes, happy to. So firstly, in regards to your question around the symptoms in comparison to what happens to the viral load decay. In our overall cohort of patients, and it's a very small cohort of patients, we didn't see much of a correlation between symptom decline and viral load decline.

However, when we looked at the patient group who had viral load in excess of the median, so greater than 5.26 logs of our viral load. We actually saw actually a surprisingly good correlation between decline in viral load and decline in symptoms. And so what that would translate to them was really that the viral load decline in patients who were treated was associated with a very much more rapid improvement in symptoms and approximately a two-day earlier overall time to resolution of symptoms. So I think that answers that question.

And then in regards to the pediatric population, yes, we are already in talks with both the EMA and the FDA in regard to our pediatric plan, and those agencies have seen the plan and have provided comments to that. And actually, I think as I mentioned in our MORNINGSKY study, we do have plans to start enrolling adolescents into that study because, obviously, it's going to be a really important patient population for that to be treated, particularly as it's taking longer for the vaccines to roll out.

Eric Joseph -- J.P. Morgan -- Analyst

Thank you. Great. Thanks for taking the questions.


So our next question comes from the line of Jonathan Miller with Evercore.

Jonathan Miller -- Evercore ISI -- Analyst

First one, on the big Phase IIIs, what percentage of the patients do you expect to be seronegative at baseline since as we've seen another direct-acting antiviral trials, those have been responsible for driving the majority of the benefit. And secondly, we've seen some recent positive results in post-exposure prophylaxis trials done with monoclonal antibodies. And we've been wondering how you think that reads through to an oral small molecule approach? Can you do even better or worse? And remind me what your time line is for initiating some sort of prophy trial, whether pre or post exposure?

Jean-Pierre Sommadossi -- Founder, Chairman, and Chief Executive Officer


Janet Hammond -- Chief Development Officer

Thanks, Jean-Pierre. So with regard to the proportion of patients who are going to be seronegative, I think to some extent, my interpretation of the literature to date has been that actually patients who are more immunocompromised and to have high viral loads tend to be seronegative, and patients who have fewer risk factors and are generally in better shape, tend to have zero -- lower viral loads and also to be seropositive. So I think that for our Phase III study, where we are planning to enroll both high- and low-risk patients and really to roll both populations into a single study, I think it's likely that we will see more patients who tend to be seropositive and seronegative because of the fact that we will have the patients who are already low-risk and likely to be seropositive. And then the patients who are high-risk I think as you saw in our hospitalized study, approximately 50% of patients were seropositive or seronegative.

So I'm guessing that, that will translate into a higher proportion of patients being seropositive. But you're right, it's a good question because I think one tends to see a better viral response or it's more easy to see that correlation in patients who start with seronegative just because they have a higher viral load initiative to start with. With regard to your question around post-exposure prophylaxis, I think that there are differences and similarities between what we're anticipating. I think we anticipate that pre-exposure prophylaxis ought to deliver similar levels of benefit to what you see with the antibodies.

I think there are both pros and cons to both approaches. The beauty of the approach of a small molecule in that type of setting, obviously, is that access is relatively considerably easier in that you don't need to go and get an injection and you can initiate therapy much more conveniently. I think the disadvantage, to some extent, will be that the monoclonal antibodies have a longer duration of effects after a single dose. Whereas the prophylaxis with a direct-acting antiviral will be dependent on taking the drug.

But of course, that means that there is more room for tailoring it. And potentially, I suppose, also ultimately less likelihood for genesis of resistance. So I think we'll have to see how it all evolves and how and what we learn. But I think that in general, there are advantages and disadvantages to both approaches, but we believe that the antiviral efficacy for both approaches ought to be very similar.

Jonathan Miller -- Evercore ISI -- Analyst

And your plans to initiate those trials?

Janet Hammond -- Chief Development Officer

Sorry, yes. We plan to initiate the trial in this second half of the year.

Jonathan Miller -- Evercore ISI -- Analyst

Thank you very much.


Your next question comes from the line of Tim Lugo with William Blair.

Lachlan Hanbury-Brown -- William Blair & Company -- Analyst

Hi guys. This is Lachlan on for Tim. First of all, I just wanted to clarify. When you said that the MORNINGSKY is enrolling globally, does that include the U.S.? Because I know that the FDA has kind of delayed that a bit in the past.

So I just wanted to check that's up and running. And second, you've said that you're looking at higher doses. Can you share any details on what that higher dose is when we might see the first data from that? Is that going to be with the MORNINGSKY readout that you said it might be late Q3, early Q4? And how much incremental efficacy you might expect to see from that, especially given the bronchoalveolar lavage that you may have shared from healthy patients.

Jean-Pierre Sommadossi -- Founder, Chairman, and Chief Executive Officer

I'm going to address the second one and Janet will go over the first one. Look, first, we anticipate that we should show a proportional increase in those concentrations. And until we don't have the data, obviously, we cannot make some extrapolation. But from the data that we see and that from the Phase I that are ongoing at higher doses, we believe that there's going to be substantial drug exposure increase.

And hopefully, this should translate in better antiviral efficacy and ultimately, a clinical benefit. So we are encouraged by the fact that we continue to see the same tolerance and safety. And obviously, we have to expand in larger cohort. Now which study will show the results, as Janet has indicated, we have six studies in parallel.

And as soon as the cohort will be completed, we'll share with the Street. Janet, do you want to address the first question?

Janet Hammond -- Chief Development Officer

So the first question, I think, was in regard to MORNINGSKY, was it currently and running in the U.S.? And the answer to that is no. It is not. We're in discussions with the FDA, but it is currently not in running in the U.S.

Lachlan Hanbury-Brown -- William Blair & Company -- Analyst

And just to follow up on that. Have they given any guidance as to how much data or how many patients worth of data they need to see to allow that to enroll? Do you have a sense of when that might be able to get up and running?

Janet Hammond -- Chief Development Officer

So we don't generally comment on those types of specifics, unfortunately. So I'm not able to answer your question.

Lachlan Hanbury-Brown -- William Blair & Company -- Analyst



[Operator instructions] And I'm showing no more questions at this time.

Jean-Pierre Sommadossi -- Founder, Chairman, and Chief Executive Officer

So thank you, everybody, for your interest and support, and appreciate. And so thank you for -- again, for joining us and continued support out there. Thank you.


[Operator signoff]

Duration: 39 minutes

Call participants:

Jonae Barnes -- Senior Vice President of Investor Relations and Corporate Communications

Jean-Pierre Sommadossi -- Founder, Chairman, and Chief Executive Officer

Janet Hammond -- Chief Development Officer

John Vavricka -- Chief Commercial Officer

Andrea Corcoran -- Chief Financial Officer, Executive Vice President of Legal

Eric Joseph -- J.P. Morgan -- Analyst

Jonathan Miller -- Evercore ISI -- Analyst

Lachlan Hanbury-Brown -- William Blair & Company -- Analyst

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