Biota Pharmaceuticals (AVIR) Q4 2020 Earnings Call Transcript

Biota Pharmaceuticals (AVIR -0.27%)
Q4 2020 Earnings Call
Mar 30, 2021, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good afternoon, ladies and gentlemen. Welcome to the Atea Pharmaceuticals' full-year 2020 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

Great. Thank you, operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals' full-year 2020 financial results conference call. Earlier today, we issued a press release which outlines the topics we plan to discuss.

You can access the press release as well as the slides that we'll be reviewing today by visiting the Investors section of our website at ir.ateapharma.com. With me today from Atea, our founder, chairman, and chief executive officer, Dr. Jean-Pierre Sommadossi; chief development officer, Dr. Janet Hammond; and chief financial officer and executive president of Llgal, Andrea Corcoran.

Our chief commercial officer, John Vavricka, will be available for the Q&A portion of today's call. Before we begin the call, just to remind you that today's discussion will contain forward-looking statements that involve risks and uncertainties. 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 turn the call over to Jean-Pierre.

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

Thank you, Jonae, and good afternoon, everyone. Thank you for joining us today on our first investor earnings call since going public in the fourth quarter of last year. 2020 was a transformational year for Atea, and we are happy to review with you the corporate and clinical progress we have made and to share our road map for the year ahead. From the founding of the company, our vision has been on the discovery and development of antiviral drugs for the treatment, cure and possibly prophylaxis of severe viral diseases, where there is a significant unmet medical need for where we can make a huge difference in patient life.

While there has been a great deal of progress in the treatment of a number of our diseases over the last 40 years, many RNA viruses continues to have no available treatment and remain the cause of severe global diseases. Today, we have a perfect example with the current COVID-19 pandemic caused by SARS-CoV-2. Early last year, our antiviral platform put us at the forefront of this fight. As we are now a year into this pandemic, SARS-CoV-2 is increasingly likely to become an endemic human coronavirus that has the potential to circulate among us for years.

Multiple COVID-19 preventive and therapeutic treatments will be essential to manage this virus. Our pure nucleotide prodrugs have pharmacological properties that are uniquely suited for the treatment and prevention of these viral diseases. Our drug candidates are designed to target viral RNA polymerase, a highly conserved enzyme critical to the life cycle replication of these viruses. Our platform offers many advantages, including potent and selective antiviral activity, convenience of all administration and scalable manufacturing, all essential when targeting millions of patients worldwide.

Turning now to Slide 4. We made tremendous clinical progress last year. With AT-527, we quickly moved to advance the COVID-19 program, filing an IND, initiating a phase 2 trial in hospitalized patients. In addition, the phase 2 biology trial in the outpatient setting is also ongoing.

Importantly, we anticipate initiating a global phase 3 program with our strategic partner, Roche, in the second quarter, and Janet would provide further details on our clinical programs later in the call. We have also been very active, publishing and presenting our results. In manuscript, highlighting preclinical results of AT-527 and COVID-19 was recently published in Antimicrobial Agents and Chemotherapy. And favorable phase 2 results were presented in March at CROI.

This month, we were also invited to present supportive data on AT-527 and COVID-19 at the International Conference on Antiviral Research or ICAR. In addition, we have diligently worked to elucidate the dual mechanism of action of AT-527 and are submitting a manuscript detailing this and the unique interactions with AT-9010 against SARS-CoV RNA polymerase. We expect publication of those datas in the near term in the peer review journal. In the meantime, we and our collaborators start at this groundbreaking research relating to COVID-19 should be shared with the world's scientific community on bioRxiv.

Turning now to our AT-752 program. We recently initiated a phase 2 clinical study in dengue fever. Again, Janet will provide greater details on this program later on the call. In addition, over the last year, we have continued to advance our other programs and training the Atea team as we move forward with late-stage development.

Moving to Slide 5. As Andrea will discuss in further detail later in the call, we have an exceptionally strong balance sheet from which to support our clinical development programs through the key value-creating inflection points. In addition to our crossover financing and our initial public offering during the fourth quarter, we also executed a significant collaboration with our partner, Roche, a global powerhouse in antiviral development, manufacturing and commercialization. With this strategic partnership, we received an upfront payment of $350 million.

The agreement provides for joint global developments at the 50-50 cost-sharing with Roche taking responsibility for global manufacturing. In addition to tiered royalties on net sales, there is potential for up to $330 million in development and regulatory milestones and an additional opportunity for up to $320 million for sales-based milestones. Let's now look at ways AT-527, our lead product candidate, may address the challenges that currently exist with the treatment and prevention of COVID-19. For the treatment of COVID-19, we believe that all direct-acting antivirals or DAAs can plan an essential role worldwide.

The clinical benefit is to rapidly inhibit viral replication in the early phase of infection and reduce disease progression for which COVID-19 will lead to a meaningful impact on global health. We believe that based on AT-527 DAA profile, it has the potential to reduce the transmission of virus, prevent or shorten hospitalization, maybe used in pre- and post-exposure prophylaxis and hopefully have an impact on long-term COVID sequelae. We view the use of the DAA as complementary to COVID vaccines and in a similar treatment paradigm to influenza, where both vaccines and drugs are used concomitantly. DAA is a relatively easy to -- and efficiently manufactured and administered.

In contrast, antibodies manufacturing and administration may be complicated and costly, creating many challenges for the healthcare system. As expected with an RNA virus, COVID-19 variants are emerging and are rapidly spreading globally. And we see the impact in the U.K., Europe, South Africa, Brazil and the United States. AT-527 targets SARS-CoV-2 RNA polymerase, a highly conserved nonstructural protein, which is also called nsp12, which is responsible for both viral RNA replication and transcription.

Given this preferential conserved target, it is anticipated that AT-527 will maintain its antiviral activity even against the recently emerging variance with mutations in the spike protein responsible for the receptor recognition and whole cell membrane fusion process. Moving to Slide 8. AT-527, as we have mentioned previously, target the RNA polymerase and essential for viral replication. This RNA polymerase has two functional domains.

Besides the RdRp, which is the well-known catalytic subunit incorporating nucleotides to RNA template, there is also an end terminal domain called NiRAN, which has a GDP binding pocket with nucleotidyltransferase activity, but its biological function was largely unknown until now. Recently, we obtained a 2.98 angstrom cryo electron microscopy structure of the quaternary complex including nsp12. Its cofactors, nsp7 and nsp8 and RNA template in AT-9010, the active triphosphate metabolite of AT-527. What is really interesting is that we saw three AT-9010 molecules binding to the nsp12.

2 of them are located in the RdRp active sites and one is incorporated with -- into the RNA templates, while the second is stalled at the pre-incorporation state, very likely causing chain termination. More importantly, a third AT-9010 molecules binds to the NiRAN active site, blocking its function. To our knowledge, this is the first time ever a description of an inhibitor binding to NiRAN has been elucidated. And now since we know exactly how the compound AT-9010 interacts with these two binding pockets, it will help us to design potentially even better inhibitors in our next generation programs.

We believe that this dual mechanisms of AT-527 are highly important as an antiviral because in collaboration with Bruno Canard, who is a world-renowned expert on viral RNA replication, we recently discovered that there are actually two distinct pathways, the NiRAN-dependent and an independent by which SARS-CoV-2 initiate RNA synthesis. For the NiRAN-dependent pathway, like the -- so the NiRAN-dependent pathway, the nsp12 NiRAN can label the nsp8 cofactor with a nucleotide, preferably the UMP, which then serves as the primer to initiate the minus-strand RNA synthesis. This is called protein-primed RNA synthesis, which was described previously only for picornaviruses. This is the first demonstration that a coronavirus NiRAN also has a similar function.

And our product candidate, so its binding to the NiRAN, is expected to block this function. The second pathway is NiRAN-independent, where the RdRp can synthesize a dinucleotide, which then serves as the primer to initiate RNA synthesis. Our product candidate can also block this function. We believe that this unique dual mechanism of inhibiting both the NiRAN and RdRp with our product candidate can potentially give us a differentiated advantage in terms of creating a high-band resistance and providing broad antiviral coverage to different variants.

With that overview, I will now turn the call over to Janet for a more intense clinical development update.

Janet Hammond -- Chief Development Officer

Thank you, Jean-Pierre. As just mentioned, COVID-19 variants have emerged and are rapidly spreading globally. We believe that the multipronged approach, including both prevention and treatment, will be essential for the challenges that we will continue to face with this virus. With the emerging variants, unfortunately, there is variable efficacy of the vaccine, and it seems that this will likely prolong the pandemic.

Also, there is considerable disparity in vaccine access and uptake in various regions, so the vast majority of the population is still unprotected. Furthermore, there are, as necessity, many different vaccines being rolled out simultaneously. And the efficacy and spectrum of protection differs between them, adding the further layer of uncertainty around who is protected and under what circumstances. A likely future scenario will be the need for booster shots.

For antibody treatment, we have already seen the efficacy decrease in the face of the new variant. As Jean-Pierre mentioned, since AT-527 targets a highly conserved viral polymerase, we anticipate that the AT-527 will retain its antiviral activity even in the presence of variants. While vaccines will play an important role in controlling the COVID-19 pandemic. We clearly are going to need additional treatment options to stay ahead of the virus and direct-acting antivirals will be an essential complement to vaccines in the evolving treatment paradigm.

As summarized on Slide 12, 2021 is expected to be an eventful year for AT-527, as highlighted by the multiple global clinical trials we plan to conduct with our partner, Roche. Throughout 2021 and beyond, we will be delivering a series of data readouts that will form our road map to a near-term NDA submission and product launch. We expect virology data from the two ongoing phase 2 studies in the second quarter. And we expect the global phase 3 program with Roche to be initiated in the second quarter.

On Slide 13 for COVID-19, a regimen of AT-527, 550 milligrams twice daily or BID were selected as the dosing reg scheme is predicted to achieve high and sustained intracellular active triphosphate levels rapidly in both the lungs and the respiratory tract, which is what is needed to inhibit SARS-CoV-2 replication. Our simulated PK profiles using data from previously completed clinical trials were recently published in Antimicrobial Agents and Chemotherapy. We conducted a phase 1 study to assess the safety and intensive PK of the 550 milligram BID regimen administered for five days to 20 subjects, randomized equally to drug or receiver in December. The top line results from the study demonstrated that AT-527 was safe and well tolerated in healthy participants as the treatment dose envisaged for COVID-19.

And these results were presented at CROI earlier this month. We're continuing to make progress with the ongoing phase 2 study in hospitalized patients. Enrollment continues, and we expect to report interim virology data on a meaningful number of patients from the study during the second quarter. And I want to point out that this is not a prespecified analysis.

As previously mentioned, this is a phase 2 proof-of-concept study and is not statistically powered. We consider this phase 2 trial to be a study where we will be able to obtain proof-of-concept for dose selection for antiviral efficacy. And also and most importantly, confirm the safety profile of the drug, which was the main reason for selecting hospitalized patient population initially. The continuing support of data for safety and tolerability will allow us to continue to move forward in the outpatient sector, which is where we anticipate ultimately, the majority of the drug will be used.

The intensive virology study currently being conducted by our partner, Roche, is evaluating the same outpatient population that the phase 3 protocol will study. There are currently sites in the U.K., Ireland, Spain, Bulgaria, Belgium and more sites are continuing to open. This study is evaluating safety, pharmacokinetics and pharmacodynamics as well as the antiviral activity of AT-527 compared to placebo in up to 220 patients. We expect interim virology data from the study on a meaningful number of patients during the second quarter.

And then as a phase 2 study, this is not statistically powered. On Slide 16, the global phase 3 trial will evaluate efficacy and safety again in the outpatient setting. We have received positive feedback on the trial design from the EMA. And we are in active dialogue with the FDA about the design of this program.

We anticipate that Roche will initiate this program in Europe in the second quarter. Turning now to our dengue fever program. If it wasn't for the COVID-19 pandemic, we would very likely be discussing outbreaks with dengue fever as we see this as a very impactful and yet unaddressed medical need. There are currently no active treatments available for dengue, and management consists of supportive care only.

This is a mosquito-borne viral disease, and there are almost 400 million individuals affected annually. Approximately 500,000 people will develop hemorrhagic fever. There's a mortality rate of 2% to 3%. This flavivirus disease is endemic in Southeast Asia, South America, the Caribbean and increasingly is encroaching into the Southern United States.

Our breakthrough drug candidate, AT-752, is a purine nucleotide prodrug with potent in vitro activity against all serotypes tested as well as against other major flaviviruses. We've demonstrated potent efficacy and excellent tolerability in a small animal model in our preclinical toxicology study. Consistent with our guidance in December, we filed a CTA in Australia and initiated a phase 1a study in healthy volunteers this March. The phase 1a study will be followed by phase 1b proof-of-concept study in adult dengue patients in Southeast Asia.

Before turning the call over to Andrea, I'd like to note that Atea's clinical development program is robust and encompasses early through late-stage studies with a steady scope data readout. Importantly, our nucleotide prodrug platform has potential against a broad array of other viral infections, including yet-to-be-identified viruses of the coronavirus and flavivirus family. As a physician scientist, this is a true privilege to be working on delivering potentially life-saving oral antivirals to patients with limited treatment options. With that, I will now turn the call over to Andrea for a review of the financials.

Andrea Corcoran -- Chief Financial Officer and Executive President of Llgal

Thank you, Janet. As Jonae mentioned in her introductory remarks, earlier today, we issued a press release containing our financial results for the full-year 2020. For 2020, our research and development costs mainly reflect the AT-527 clinical development program costs related to the advancement of AT-527 from IND to late-stage testing for COVID-19. Our general and administrative expenses are primarily driven by the growth of our organization through the expansion of personnel across several key functions.

On Slide 21, I am pleased to report that we ended 2020 with an exceptionally strong balance sheet to support our clinical development programs and business activities. In addition to our crossover financing of $215 million and the net proceeds from our initial public offering in the amount of $317.6 million, during the fourth quarter of 2020, we also executed this collaboration with Roche, pursuant to which we received an upfront payment of $350 million. As a result, as of December 31, 2020, cash and cash equivalents were $850.1 million. Our current cash runway takes us through 2023.

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. These are exciting times at Atea, and we are very proud of the important progress we have made and the contribution we expect to make in fighting COVID-19. We look forward to sharing data on the two phase 2 clinical trials in the near term and the initiation of the phase 3 program. As most of you know, moving from IND to potential product launch in less than two years for a DAA small molecule is a Herculean effort.

Before opening the call to your questions, I would like to take this opportunity to express my gratitude to the exceptional Atea team; our strategic partner, Roche; the researchers; the physicians; and the patients supporting our clinical and regulatory advancement. Without the collaboration and support, we will not have achieved the accelerated progress we have made to date. With that, operator, we will now open the call up to your questions.

Questions & Answers:

Operator

Thank you. [Operator instructions] Your first question comes from the line of Eric Joseph with J.P. Morgan. Your line is open.

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

Good evening. Thanks for taking the questions. A few from us. First, in looking to the interim virology data in the phase 2 trials next quarter, could you set the stage here a little bit with respect to how frequently your sampling viral -- what would be viewed as a meaningful reduction? Are you also looking at -- are you looking at viral clearance? And then to what extent are you also going to be looking at COVID symptomatology? And I have a couple of follow-ups.

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

Thank you, Eric, for the question. Janet?

Janet Hammond -- Chief Development Officer

So Eric, we're looking at the viral kinetics in terms of sampling, obviously at the entry to the study and then on day 1, day 2, day 5, day 8, day 10 and day 14. So we should have a reasonable scatter, and we should be able to see good viral kinetics because we are obtaining frequent sample. And then with regard to -- I'm sorry. I think I'm forgetting the rest of your question, if you wouldn't mind repeating.

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

Are you interested in seeing viral clearance or just looking at viral reduction? And I guess you're also able to gather information with respect to symptomatology or symptom reduction.

Janet Hammond -- Chief Development Officer

So we hope to see viral clearance as well as viral reduction, and we're looking for that. Symptoms are also being collected, but the symptoms are not being self-supported, they're being collected by the investigator. So we -- but we will have information on symptom reduction as well.

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

OK. Got it. And with respect to the drug-drug interaction trials, can you just walk us through what FDA -- what regulators are interested in seeing there? And particularly with the crossover study with carbamazepine, just what's the rationale for looking at how AT-527 interacts with that compound? What's it a stand-in for? I assume it's standing -- it's a stand-in for some kind of pharmacology or polypharmacy in the population. Thanks.

Janet Hammond -- Chief Development Officer

Well, I think -- so DDI studies are really pretty much the routine DDI studies that you would anticipate really for any regulatory package in anticipation of an NDA submission. And as a nucleotide, we don't anticipate that the drug interaction profile is going to be all that unusual and rather similar to some of the other nucleotide drugs that one is already familiar with. With regard to the carbamazepine study, we know that AT-527 is a Pgp -- has some Pgp interaction. And so carbamazepine is being evaluated here because carbamazepine has been a portent Pgp inducer and potentially one might need to dose at higher doses of AT-527 in combination with carbamazepine.

And of course, with a disease such as COVID-19, we're anticipating a broad array of patients who might need to receive this drug. And so in some ways, it's not a target for anything, but really an important aspect of understanding how to administer the drug to patients with epilepsy and other such diseases.

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

OK. Great. Thanks. Thanks so much for taking the questions.

Operator

Your next question comes from the line of Matthew Harrison with Morgan Stanley. Your line is open.

Zhen Zeng -- Morgan Stanley -- Analyst

Hello. This is Zhen Zeng for Matthew. Congrats on the progress. I have two questions.

The first one is, how is the current enrollment status with the COVID phase 2 study in a hospitalized setting? And the second one is, in the same study, would you expect to see any improvement in clinical markers?

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

Janet?

Janet Hammond -- Chief Development Officer

So the enrollment continues, and we are slowly enrolling patients into the study. I would say that the enrollment has been challenging for a number of reasons, some of which we've mentioned before, but really, just to highlight for you the fact that the patient population that we're attempting to enroll is a patient population with moderate COVID-19, who require hospitalization, but who don't require mechanical or very active support of ventilation. So they're required to immediately hospitalize and potentially to require oxygen support with nasal cannula only to qualify for the study. And then the idea is really for the primary endpoint to measure progression from that point or lack thereof.

But in the case of a surge of COVID-19, patient populations doesn't really exist in the hospitalized setting for the most part because patients need to be considerably sicker than this to be enrolled -- to be admitted to hospitals. So that has really made it quite challenging to find these patients and the window in the COVID pandemic to when such patients are eligible for admission to hospital. And nevertheless, we continue to enroll patients. However, perhaps less so in the United States, particularly also because of the changes in the standard of care that have particularly impacted the treatment in the United States and the approval of remdesivir and the antibodies.

These are less accessible outside of the United States, which makes it a little easier there. Nevertheless, enrollment is slow and -- but we continue to persevere with it. And with regard to the symptoms, yes, we are connecting clinical symptom improvement by the investigator as they observe the patients during treatments. So we will have information on more.

Zhen Zeng -- Morgan Stanley -- Analyst

Got it. Thanks. And how about the second question? Any -- do you see any clinical markers improvements from the study?

Janet Hammond -- Chief Development Officer

So the -- we will have, as I mentioned, the clinical symptom improvement, but the study is ongoing and remains blinded. So I can't -- I don't have any information around clinical symptom improvement at the moment.

Zhen Zeng -- Morgan Stanley -- Analyst

OK. Thank you very much.

Operator

Your next question comes from the line of Jon Miller with Evercore ISI. Your line is open.

Jon Miller -- Evercore ISI -- Analyst

Thanks for taking the question, guys. I think just a follow-up to that previous one. I understand that enrollment has been challenging for the phase 2s in the past. Can you talk a little bit about how you're adapting your strategy going forward into the phase 3 and what the push pulls are on implement time lines and readout time lines as we look at phase 3?

Janet Hammond -- Chief Development Officer

So that the -- what -- really, essentially, what we're doing is trying to have as comprehensive a list of sites around the world in anticipation of the pandemic moving from place to place because one's got to be one step ahead of the ball, all of the time. And really, I think that is the best strategy that we have been able to come up with. We hope that the outpatient studies will be somewhat easier to enroll because there aren't going to be these requirements for hospitalization, which have really put a -- I think, a filter on what we've been able to do with that study. But we are also prepared to the fact that I think this is also going to be challenging.

And we have really tried to throw the net as widely as we can to have as many sites as possible.

Jon Miller -- Evercore ISI -- Analyst

Excellent. Thank you. And I suppose one more follow-up on mechanism. J.P., I know you've -- you both hit multiple times, the fact that RdRp is a highly conserved protein and dual mechanism of action might help you prevent viral escape from that.

But in your preclinical -- understood -- but maybe a finer point on it, in your preclinical work thus far, have you observed viral escape mutations against 527 in general? And if so, how would you characterize the mutants and their likelihood of popping up in the real world?

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

No. It's a good question, Jon. And we are looking at it right now. So right now, we have two important in vitro studies ongoing.

One is to see if we can generate resistant mutants. As you know, it will be very difficult to do that in SARS-CoV-2. In fact, it's SARS, that's why we are doing that at Utah State, the NIAID contractor, with Huh-7 cells infected with OC43, which is a human season of coronaviruses, as you know, which is also a better coronavirus. And so those studies are ongoing.

Definitely in the next couple of months, we should have the data. Now I should -- and you can check the manuscript on bio life, so you can see that we have a very good knowledge of all the amino acids. What -- we have the binding, both in the NiRAN and the RdRp. And then lastly, we are investigating also as they are available, the U.K., the South African and the Brazilian variants are -- as we speak as well.

So we will have data in contrast to antibodies, where you can use a surrogate files here, we have to use a live house, as you know, to evaluate those -- in those assays. So that is ongoing. And I'm sure that at the next call, we will have the data to share with you.

Jon Miller -- Evercore ISI -- Analyst

Thank you very much.

Operator

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

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

Hey. This is Lachlan on for Tim. So I had a couple. I guess, first of all, as it relates to, yes, the phase 2 trial, have you seen any sort of new safety signals at the BID dose that you didn't see at the BIDs that you used previously? And second of all, I noticed that you're expanding the intensive virology study sort of geographically.

Is there rationale for that beyond just accelerating enrollment?

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

Janet?

Janet Hammond -- Chief Development Officer

So your second question, no, the -- we're expanding the study really to ensure that we're able to enroll it as expeditiously as possible. And there is no other rationale behind that. I'm sorry, and your first question was --

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

About safety.

Janet Hammond -- Chief Development Officer

Oh, the safety. No. So there has been -- the safety profile has been similar to what we encountered with the 550 milligrams once a day. The safety continues to be very -- it seems to be safe and well tolerated, which has two DSMB.

The second one was in December, but we've continued to enroll patients subsequent to that and there have been no serious adverse events which have been considered drug related. And so the safety and tolerability continue to be very pleasing to see.

Operator

There are no further questions at this time. I would like to turn the call back over to speaker Jean-Pierre Sommadossi for closing remarks. Go ahead, sir.

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

Thank you again for joining us, and thank you for your continued support of Atea. Thank you.

Operator

[Operator signoff]

Duration: 40 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

Andrea Corcoran -- Chief Financial Officer and Executive President of Llgal

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

Zhen Zeng -- Morgan Stanley -- Analyst

Jon Miller -- Evercore ISI -- Analyst

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

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