Q1 2020 Earnings Call

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Operator: Welcome to the Regeneron Pharmaceuticals First Quarter 2020 Earnings Conference Call. My name is Crystal, and I will be your operator for today. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference is being recorded. I would now like to turn the conference over to Justin Hoko, Vice President of Investor Relations. You may begin.

My name is crystal and I will be your operator for today's call.

This time, all participants are in a listen only mode.

Later, we will conduct a question and answer session.

Please note that this conference is being recorded I.

I would now like to turn the conference over to just didn't hopeful Vice President of Investor Relations you may begin.

Justin Hoko: Thank you, Crystal. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron Pharmaceuticals and welcome to the first quarter 2020 conference call. An archive of this webcast will be available on our website. Joining me on the call today are Dr. Leonard Schleifer, Founder, President, and Chief Executive Officer; Dr. George Yancopoulos, Co-Founder, President, and Chief Scientific Officer; Marion McCourt, Senior Vice President and Head of Commercial; and Bob Landry, Executive Vice President and Chief Financial Officer.

Thank you Crystal good morning, good afternoon, and good evening, everyone listening around the world.

Thank you for your interest in Regeneron Pharmaceuticals, and welcome to the first quarter 2020 conference call. An archive of this webcast will be away salable on our website joining.

Joining me on the call today are Dr., Leonard Schleifer, founder President and Chief Executive Officer, Dr., George Yancopoulos Co founder President and Chief Scientific Officer, Merian Mccourt Senior Vice President and head of commercial and Bob Landry Executive Vice President and Chief Financial Officer. After our prepared remarks, we will open.

Justin Hoko: After our prepared remarks, we will open the call for Q&A. I would also like to remind you that remarks made on today's call include forward-looking statements about Regeneron. Such statements may include, but are not limited to, those related to Regeneron and its products and business, financial forecasts and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement issues, intellectual property, pending litigation and other proceedings, and competition. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarterly period ended March 31, 2020, which was filed with the SEC today.

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I'd also like to remind you that remarks made on todays call include forward looking statements about regeneron.

Statements may include but are not limited to those related to regeneron and its products than business financial forecast in guidance development programs and related anticipated milestones collaboration finances regulatory matters payer coverage and reimbursement issues intellectual property pending litigation and.

The proceedings and competition.

Each forward looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement.

A more complete description of these and other material risks can be found in regenerons filings with the United States Securities and Exchange Commission, including its form 10-Q for the quarterly period ended March 31st 2020, which has been filed with the FCC today.

Justin Hoko: Regeneron does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise. In addition, please note that GAAP and non-GAAP measures will be discussed in today's call. Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available in our financial results press release, which can be accessed on our website. Additional information about those measures is also available in the Investor and Media section of our website. Once our call concludes, Bob Landry and the IR team will be available to answer further questions. With that said, let me turn the call over to our president and chief executive officer, Dr. Len Schleifer. Len?

Regeneron does not undertake any obligation to update publicly any forward looking statements, whether as a result of new information future events or otherwise.

In addition, please note that GAAP and non-GAAP measures will be discussed in today's call information regarding our use of non-GAAP financial measures in a reconciliation of those measures to GAAP is available in our financial results press release, which can be accessed on our website.

Additional information about those measures is also available on the Investor and media section of our website.

Since our call concludes Bob Landry on the IR team will be available to answer further questions with that let me turn the call over to our President and Chief Executive Officer, Dr. lunch Lifer Lynn.

Len Schleifer: Thank you, Juspin.

Thank you Justin.

Len Schleifer: And thank you to everyone for joining the call. I hope all of you are staying safe and well during this difficult time. We're living in a new reality, the reality of COVID-19. I am incredibly proud of the leadership role Regeneron is taking in the fight against COVID-19. Clearly, this pandemic is unprecedented in our lifetime, for our company, our country, and the world, and for world economies. Regeneron has spent decades and billions of dollars developing proprietary technologies that have created medical breakthroughs, such as Dupixent and our novel antibody cocktail for Ebola, which is now under FDA review. These same technologies are now well-suited to finding a treatment against the SARS-CoV-2 virus. We are making rapid progress in scaling up supply of our novel antibody cocktail, which we expect to be in clinical trials this June. We are optimistic about this approach, which George will describe in greater detail.

And thank you to everyone for joining the call I hope all of you are staying safe and well during this difficult time.

We're living in a new reality the reality of covert 19.

Hi, I'm incredibly proud of the leadership role Regeneron is taking in the fight against covert 19, clearly this pandemic is unprecedented in our lifetime for our company our country in the world and the world economies.

General on has spent decades and billions of dollars developing proprietary technologies that have created medical breakthroughs such as Dupixent.

Novel antibody cocktail for we Bola, which is now under FDA review.

These same technologies are now well purpose finding a treatment against the Sars Cove to virus, we are making rapid progress and scaling up supply of our novel antibody cocktail, which we expect to be in clinical trials. This June.

We are optimistic about this approach, which George will describe in greater detail.

Len Schleifer: Also, we are working swiftly with our collaborator Sanofi to find a definitive answer on whether there is a role for Kevzara in helping to alleviate the devastating inflammation that affects patients who are critically afflicted with this virus. We are grateful for the tremendous partnership across industries, governments, and agencies such as the FDA and BARDA as we unite in the common cause to eradicate this disease. Beyond our therapeutic efforts, we continue to respond to other urgent COVID-related needs. We recently produced and donated viral transport media to New York State for use in 500,000 test kits, and we have provided financial support to nonprofits at the heart of the pandemic response in New York and beyond.

Also we are working swiftly with a collaborator Sanofi to find a definitive answer on whether there was a role for kevzara and helping to alleviate the devastating inflammation that affects patients who are critically afflicted with this virus.

Grateful for the tremendous partnership of course industries governments and agencies, such as the FDA and BARDA as we unite and the common cause to eradicate this disease.

Beyond a therapeutic efforts, we continue to respond to other urgent coal would relate it needs. We recently produced and donated viral transport media to New York State for use in 500000 test kits and have provided financial support to non profits at the heart of the pandemic response in New York.

And beyond.

Len Schleifer: Furthermore, we are sensitive to the rapidly evolving marketplace and working with customers to ensure that patients are able to receive the treatments they need to preserve vision as well as to treat inflammatory conditions, cancer, and other ailments that persist despite the realities of social distancing. Turning to some brief commentary on the first quarter, where we delivered another strong performance, negative impacts from COVID-19 were minimal.

Furthermore, we are sensitive to the rapidly evolving marketplace and working with customers to ensure that patients are able to receive the treatments they need to preserve vision as well as to treat inflammatory conditions cancer and other elements that persists, despite the realities of social dish distancing.

Turning to some brief commentary on the first quarter, where we delivered another strong performance in the quarter negative impacts from covert 19 were minimal.

Len Schleifer: Our core brands, ILEA, DUPIXENT, and LIBTIO, drove significant top and bottom line growth based on demand while we invested in and advanced our innovative pipeline. In this quarter, ILEA global net product sales grew 6% to $1.85 billion, including U.S. ILEA net sales growth of 9% to $1.17 billion. In the last two weeks of March and early April, overall demand and new patient starts were softer due to COVID-19. However, we are encouraged by the rebound in demand in the most recent weeks. Marion will give you more color.

Core brands I, Leah Dupixent <unk> drove significant top and bottom line growth based on demand, while we invested in advanced innovative pipeline.

In this quarter I look at global net product sales grew 6% to $1.85 billion, including U.S. idly, a net sales growth of 9% to $1.17 billion.

In the last two weeks of March in early April overall demand and new patient starts were soft due to cope with 19.

However, we are encouraged by the rebound in demand in the most recent weeks.

Give you more color on this.

Len Schleifer: First quarter Dupixent sales more than doubled compared to last year and are now annualizing at more than $3.4 billion due to continued market penetration and new launches in multiple disease settings. While there are early signs of impacts on new patient starts, we expect continued resilience for Dupixent during this COVID-19 period, given the profound efficacy and safety profile. With anticipated regulatory action in pediatric atopic dermatitis later this month and other data readouts in 2020, and initiation of new phase 3 trials assessing butypixen and several other type 2 inflammatory diseases, this exceptional medicine continues to be positioned for long-term growth. Importantly, Dupixent is driving continued diversification of our earnings base and enhancing our strong current and long-term financial position.

This quarter Dupixent sales more than doubled compared to last year and are now annualizing at more than 3.4 billion on continued market penetration and new launches in multiple disease settings.

While there are early signs of impacts on new patient starts. We expect continued resilience to dupixent doing this covert nitric period, given the profound efficacy and safety profile.

With an anticipated regulatory action in pediatric atopic dermatitis later this month and other data read outs and 2020 and initiation of new phase three trials assessing due to picks and several other type two inflammatory diseases.

This exceptional Madison continues to be positioned for long term growth importantly, dupixent is driving continued diversification of our earnings base and enhancing our current <unk>, our strong current and long term financial position.

Len Schleifer: We also announced recently that we have completed the restructuring of our agreement with Sanofi on Praluent, which will lead to immediate accretion and further strengthen our overall portfolio. 2020 has brought us urgent new priorities. Even though we are experiencing impacts to trial enrollment and new study starts, we remain on track for several significant clinical milestones, particularly in oncology. Recently, we announced that our first-line clinical trial in lung cancer, assessing libtio, was stopped early due to superior overall survival versus chemotherapy. We will look to submit these data to regulators as soon as possible. We also intend to submit data for leptio and basal cell carcinoma and expect new data from our biospecifics program later this year. Additionally, the long-awaited Phase III readout from Ficiniumab, our anti-nerve growth factor program for osteoarthritis pain, will occur in the coming months.

We also announced recently that we have completed the restructuring of our agreement with Sanofi on Praluent, which will lead to immediate accretion and further strengthen our overall portfolio.

2020 has brought urgent new <unk> priorities.

Even though we are experiencing impacts to trial enrollment and new studies starts we remain on track for <unk>, several significant clinical milestones, particularly in oncology.

Recently, we announced that our first line clinical trial in lung cancer assessing live Tiotwo stopped early on an interim analysis due to superior overall survival versus chemotherapy.

We will look to submit these data to regulators as soon as possible.

We also intend to submit data for the tight went basal cell carcinoma and expect new data from our bi specifics program late this year.

Additionally, the long awaited phase three readout from for senior Matt.

Anti nerve growth factor program for osteoarthritis pain will occur in the coming months.

Len Schleifer: Before handing the call over to George, I want to share the immense pride and gratitude we have for our people working hard at Regeneron during this time. Even in the current environment, our entire business is operating as our people drive important work forward that is essential to our mission, to patients, and to near and long-term value creation for shareholders. Our ability to do this rests on the talent and strength of our workforce, which, in spite of COVID-related disruption, maintains incredible commitment, focus, and effort to advance the breadth of Regeneron's work. They are the foundations for moving forward our mission in normal times and especially now. We are optimistic that Regeneron and our society will prevail through these unprecedented times, and we will work tirelessly to that end. Now, I'll turn the call over to George.

Before handing the call over to George I want to share the immense pride and grew attitude we have for up people working hard at Regeneron doing this time.

Even in the current environment, our entire business is operating as a people drive an important work forward that is essential to our mission to patients and to near and long term value creation for shareholders.

Our ability to do this rests on the talent and strength of our workforce, which in spite of covert related disruption maintains incredible commitment focus and effort to advance the breath Regenerons work.

They are the foundations for moving forward, our mission in normal times, and especially now.

We are optimistic that regeneron and our society will prevail through these unprecedented times and we will work tirelessly to that it now I'll turn the call call over to George.

George D. Yancopoulos: Thank you, Len. And since the devastating COVID-19 crisis is foremost on everyone's mind, I will first discuss our efforts in this area. As you all know, our state-of-the-art and proprietary VelociSuite technology, which we have built over the last few decades, can be very powerful for responding to new targets and pathogens, as we recently proved by rapidly creating an antiviral antibody cocktail as an effective treatment for Ebola. Recall that the FDA recently granted priority review to this treatment for Ebola, with the target action date of October 25, 2020, based on the results of the Phase III Palm clinical trial conducted in the Congo, which was stopped early because of our Regeneron EB3 antibody cocktail proving superior in preventing death compared to the previous standard of care, the so-called ZMAP antibody, as well as 2 remdesivir.

Thank you Glenn.

And since the devastating covert 19 crisis is foremost on everyone's mind I will first discuss our efforts in this area.

As you all know our state of the yard and proprietary for losses, we technologies, which we have built over the last few decades can be very powerful for responding to new targets and pathogens as we recently proved by rapidly creating an anti viral antibody cocktail as an effective treatment for both.

Recall, the F.D. recently granted priority review to this treatment for both with the target action date leftover 25th 2020 based on the results of the phase three.

Clinical trial conducted in the condo, which was stopped early because of our Regeneron E. B three antibody cocktail proving superior in preventing debt compared to the previous standard of care so-called xenapp antibody as well as two of them doesn't feel.

George D. Yancopoulos: In terms of COVID-19, while society is awaiting an effective vaccine that could still be a year or two away, we are employing a two-pronged approach that could serve as a useful bridge and or as an alternative to a vaccine. First and most importantly, we are developing a novel antiviral antibody cocktail, just as we did for Ebola. We have already announced that we have utilized our VelociSuite technologies to rapidly generate and select thousands of potent antiviral fully human antibodies from both our genetically humanized velocimune mice as well as from convalescing human volunteers, creating what we believe is the largest and deepest collection of potent antiviral antibodies to choose from. We have selected two distinct antibody cocktails from this collection: our initial cocktail, as well as a backer. We have already begun large-scale manufacturing and anticipate initiating clinical trials with the lead cocktail in June. With Ebola, we set the record of nine months from initiating the project to starting human trials. Now, we hope to break that record with five months from project initiation to the clinic.

In terms of covert 19, well society is waiting an effective vaccine that could still be a year or two away. We are employing a two pronged approach that could serve as useful bridge indoor as an alternative to vaccine.

First and most importantly, we are developing a novel anti <unk> antibody cocktail just as we did for a bowl.

You've already announced that we've utilized or lots. This we technologies to rapidly generate and select thousands of potent anti viral fully human antibody from both our genetically humanized velocimmune mice as well it's from Convalescing human volunteers.

Grading what we believe is the largest deepens collection potent anti viral antibodies to choose from.

We have selected two distinct anybody cocktails from this collection.

Our initial cocktail as well as a backup and we've already begun large scale manufacturing and anticipate initiating clinical trials with the LICAT deal in June.

With a bolus, we set the record of nine months from initiating the project starting human trials now we hope to break that record.

Five months from project initiation to the clinic.

George D. Yancopoulos: Based on our experience with Ebola and other viruses, we hope that this specifically designed antiviral approach has a significant chance of success in providing both a prophylactic treatment to prevent infection in those at risk, as well as for treating those already infected and symptomatic. Our second major COVID-19 approach involves repurposing Kivzara, our anti-IL-6 receptor antibody approved for rheumatoid arthritis. Based on a small, uncontrolled case series from China, there was reason to believe that blocking the IL-6 pathway might address the underlying inflammation leading to acute respiratory distress in so-called severe COVID-19 patients, meaning hospitalized patients needing oxygen support but not on ventilators, as opposed to so-called critical patients who largely require ventilation.

Based on our experience with the bowling other viruses, we hope that this specifically designed anti viral approach has a significant chance for success in providing both the prophylactic treatment to prevent infection in those at risk.

As well as for treating those already infected and symptomatic.

Our second major covert 19 approach involves re purposing kevzara or anti IL six receptor antibody approved in rheumatoid arthritis.

Based on a small uncontrolled K series from China.

Was reasonably that blocking the iosix pathway might address the underlying inflammation, leading to acute respiratory distress and so called severe cold 19 patients, meaning hospitalized patients needing auction support but not on ventilators as opposed to so called critical patients who largely require ventilators.

We initiated an adaptive phase two three trial to explore kids are in both the severe and critical patient populations. Our initial data from both the phase two in phase three portion of the trail indicated that kids are at least at the doses tested which parallel those used in the China reports.

George D. Yancopoulos: We initiated an adaptive phase 2-3 trial to explore Kevzara in both the severe and critical patient population. Our initial data from both the Phase 2 and Phase 3 portions of the trial indicated that Kifzara, at least at the doses tested, which paralleled those used in the Chinese reports, did not provide a major benefit for severe patients. On the other hand, the phase two portion of the trial suggested a potential benefit in critical patients, and the phase 3 trial in this group is ongoing. Additional efforts, both in our program and by our Sanofi partners in Europe and the rest of the world, are further testing both of these populations, including at higher doses.

Did not provide a major benefits the severe patients.

On the other hand, the phase two portion of the trial suggested a potential benefit in critical patient.

And the phase three trial in this group is ongoing.

Additional efforts both in our program and bar see NFI partners in Europe, and the rest of the world or further testing both of these populations, including at higher doses.

George D. Yancopoulos: Our results and efforts with Kevzara highlight the challenges with using repurposed drugs, the inability to rely on uncontrolled and even small controlled trials, and thus the importance of running large, well-controlled phase 3 studies to obtain real answers as to whether a drug has benefits, and the quantitative extent of that benefit, even in a pandemic setting. It is important to point out that our efforts with COVID-19 are being developed in an ongoing collaboration with BARDA, a division within the U.S. Department of Health and Human Services, and also involve incredibly collaborative relationships with so many critical partners, from the FDA to the leadership of New York State to the many hospitals and physicians at the front lines who make the effort to engage in these trials and the many stricken patients who volunteer to participate. I also want to thank all the individuals at Regeneron who have continued to work tirelessly on these programs despite all the logistical, operational, and health challenges created by the COVID-19 crisis. Moving on from COVID-19 I first want to touch upon our ILEA program.

Even in a pandemic setting.

It's important to point out that our efforts would cover 19 are being developed under an ongoing collaboration with BARDA division within the U.S. Department of health and human services and also involved incredibly collateral live relationships with so many critical partners from the F.D.A. to the leadership of New York State to them.

The hospitals and physicians at the front lines, who make the effort to engage in these trials and the many stricken pot patients who volunteer to participate.

I also want to think all the individuals that regeneron, who have continued to work tirelessly on these programs. Despite all the logistical and operational and health challenges created by the covert 19 crisis.

Moving on from covert 19.

My first want to touch upon our I leave programs.

George D. Yancopoulos: Physicians consider safety to be essential in selecting anti-VEGF treatments. In the last several months, another recently approved anti-VEGF product was recently associated with a serious, new, vision-threatening safety concern involving occlusive retinal vasculitis in the context of intraocular inflammation. In light of the frequency and serious nature of this safety concern, Regeneron and our partner Bayer conducted a broad review of our clinical trial database as well as our post-marketing global safety database to identify any similar safety events with ILEA. In the critical trial database from eight phase three trials involving tens of thousands of injections, there were no reports consistent with safety. Moreover, in the extensive post-marketing experience involving more than 32 million doses of Based on our reviews of the ILEA clinical trial database and post-marketing surveillance, occlusive retinal vasculitis in the context of intraocular inflammation does not appear to be a safety concern with the use of ILEA. Next, I want to discuss DuPixote.

<unk> consider safety to be essential and selecting anti veggie of treatment over.

Over the last several months another recently approved anti that Jeff product was recently associated with this serious new vision threatening safety concern involving occlusive retinal vasculitis in the context of <unk> inflammation.

In light of the frequency and serious nature of the safety concern regeneron in our partner Bayer conducted a broad review or clinical trial database as well as our post marketing global safety database to identify any similar safety events with alia.

In a critical trial database from eight phase three trials involving tens of thousands of injections.

There was no reports consistent with the safety concerns.

Moreover, in the extensive post marketing experience involving more than 32 million doses of ilea sold in more than 100 countries worldwide since its approval more than eight years ago. The rate of any possibly related safety event was less than one out of every 6 million ilea doses. So.

In such cases were always associated with presumed infectious and <unk>.

Yes.

Based on our views of the Ilea clinical trial database and Postmarketing surveillance occlusive retinal vasculitis in the context intra okcular inflammation does not appear to be a safety concern with the use of ilea.

Next I want to discuss Dupixent.

George D. Yancopoulos: Later this month, we anticipate an FDA decision extending Dupixent approval to 6 to 11-year-old children suffering from atopic dermatitis. Dupixent would be the first biological treatment for this pediatric population. We hope this potential approval will continue to reflect the remarkable safety profile of Dupixent as evidenced by the absence of a black box warning or any associated serious infection risk, which are often seen with immunomodulatory biologics and with JAK inhibitors. We also expect FDA action on our 300 mg auto-injector, which would allow for an additional dimension of convenience to an already strong profile for the medicine. Additionally, later this year, we anticipate data from our Phase III Pediatric Asthma Trial, the Phase II portion of our eosinophilic esophagitis program, and we remind you that we have pivotal studies in chronic spontaneous urticaria, prurigo nodularis, and bullous pemphigoid, as well as studies in oral immunotherapy with our collaborator, Amir.

Later this month, we anticipate in F.D.A. decision, extending two picks and approval to six to 11 year old children suffering from a topic dermatitis.

Picks it would be the first biological indicated for this pediatric population. We hope this potential approval will continue to reflect the remarkable safety profile of dupixent as evidenced by the absence of a black box warning or any associated serious infection risk.

Which are often seen with immunomodulatory biologics and with Jack inhibitors.

We also expect F.D. action on our three engine milligram, Autoinjector, which would allow for an additional dimension of convenience tuned already strong profile for the medicine.

Additionally, later this year, we anticipate data from our phase three pediatric asthma trial. The phase two portion of our eosinophilic Assefa Janus program and remind you that we have pivotal studies in chronic spontaneous or a carrier <unk> and bullets pemphigoid as well as studies.

Oral immunotherapy with our collaborator Amy.

George D. Yancopoulos: We continue to build on the Dickson story, which has already changed the lives of so many people suffering from type 2 inflammatory diseases, asthma, atopic dermatitis, and chronic rhinocytis with nasal polyps, with more than a hundred and fifty thousand patients treated globally since launch. Next, I'm excited to share important updates on our immuno-oncology efforts. As you know, most cancer patients are still not successfully addressed with immune therapy, leaving us with the major challenge of enhancing responsiveness in tumor settings where immune therapies already have some efficacy, such as lung and melanoma, while also trying to extend the benefit to patients with tumors that are currently not highly responsive, such as prostate, pancreas, and colon. Having our own effective anti-PD-1 antibody is foundational for our efforts to enhance and extend the benefits of immunotherapy, as we had hoped such an antibody could play an important role both as a monotherapy and in combination with other antibodies and bispecifics derived from our own homegrown pipeline, as well as in combination with a number of collaborative agents and vaccines. However, despite early optimism, developing effective anti-PD-1 antibodies has proven to be very challenging It is remarkable that in the decade since the first approval of an immunoecology agent, only one PD-1 antibody has been approved as monotherapy in first-line, non-small-cell lung cancer, although that therapy has, on its own, completely changed the paradigm of how lung cancer is treated.

Continue to build on fixing story, which has already changed the lives of so many people suffering from type too inflammatory diseases, such as asthma, a top dermatitis and chronic wine aside is with nasal pots with more than 150000 patients treated globally since launch.

Next I'm excited to share important updates on our Immunooncology efforts as you know most cancer patients are still not successfully address with immune therapies.

Bring us with a major challenge of enhancing responsiveness in tumor settings, where immune therapies already have some advocacy such as long and melanoma.

Also trying to extend the benefit patients with tumors, they're currently not highly responsive switches prostate pancreas and colon.

Having our own effective anti P.D., one antibody is foundational for our efforts to enhance and extend the benefits of immunotherapy as weird hopes such an antibody could play an important role both as a monotherapies, but also in combination with other antibodies in buys specifics.

Right from our own home grown pipeline as well as in combination with a number of collaborative agents and vaccines.

Defying early optimism developing effective anti P.D., one antibodies has proven to be very challenging.

It is remarkable.

That in a decade since the first approval of an Immunoncology agent.

Only one P.D. one antibody has been approved as motto therapy in first line Nonsmall, so lung cancer.

Although that there'll be has on its own completely changed the paradigm of how lung cancer is treated.

George D. Yancopoulos: At the end of last year, we announced interim results from our first-line non-small-cell lung cancer study in so-called PD-L1 high-risk patients, revealing that our PD-1 antibody, Liptio, as monotherapy had objective response rates of 42% compared to 22% for chemotherapy, indicating profound clinical activity. Just last week, we announced that the Independent Data Monitoring Committee recommendation led to an early termination of this Leptio monotherapy trial due to a highly significant improvement in overall survival, with Leptio decreasing the risk of death by 32.4% compared to platinum doublet chemotherapy. This result was obtained early, despite a third of the patients entering the trial within the past six months and chemotherapy patients being able to cross over to Leptio upon disease progression. No new leptile safety signal was identified.

At the end of last year, we announce interim results from our first line Nonsmall. So lung cancer study in so-called PDL one high patients.

Revealing that RPD, one antibody lip tile as Mano therapy at objective response rates of 42% compared to 22% for chemotherapy, indicating profound clinical activity.

Just last week, we announced that the independent Dana Monterey Committee recommendation led to an early termination of this loop tile monotherapies trout.

Due to a highly significant improvement in overall survival with look tyo decreasing the risk of debt by 32.4% compared to the platinum doublet chemotherapy.

This result was obtained early despite a third of the patients entering the trial within the past six months and chemotherapy chemotherapy patients being able to crossover no tyo upon disease progression.

No new look tile safety signal was identified.

George D. Yancopoulos: We are planning to present detailed trial data at a future medical meeting and will complete regulatory submissions in the next few months. And just this morning, we announced that we had identified yet another first-in-class cancer setting where leptile asthma therapy exhibited profound and clinically meaningful activity. Just as we had previously done for squamous cell carcinoma of the skin, or CSCC, where leptio is rapidly becoming standard of care, our potentially pivotal study in second-line advanced basal cell carcinoma of the skin, or BCC, demonstrated clinically meaningful response rates of nearly 30% in locally advanced patients who had progressed on prior hedgehog inhibitor treatment. Impressively, more than 85% of the patients who responded to treatment have experienced durable responses of more than 12 months. We intend to submit the results of this study to regulatory authorities in the coming months.

We are planning to present detailed trial data at a future medical meeting and we'll complete regulatory submissions in the next few months.

And just this morning, we announced.

We had identified yet another first in class cancer setting, we're look tile as motto therapy exhibited profound and clinically meaningful activity.

Just as we had previously done for squamous cell carcinoma. The skin. We're C.S.C.C. were look tire is rapidly becoming standard of care.

Or potentially payroll study in second line advanced Baysal cell carcinoma skin or B.C.C.

<unk> clinically meaningful response rates of nearly 30% in locally advanced patients who had progressed on prior hedgehog inhibitor treatment.

Impressively more than 85% of the patients who responded to treatment have experienced durable responses of more than 12 months.

We intend to submit.

Dated to regulatory authorities in the coming months.

George D. Yancopoulos: Basal cell carcinoma presents another promising opportunity to extend our dermato-oncology portfolio beyond the current squamous cell carcinoma indication. BCC is the most common cancer in the world. While only a very small percentage of cases require systemic therapy, the extremely high incidence of this cancer means that there are still thousands of people with advanced basal cell carcinoma in need of treatment. I'd like to discuss the significance of these milestones for cancer patients and for Regeneron. In aggregate, our studies have now demonstrated that Liptio is a potent and effective PD-1 monotherapy treatment, so we now have the potential, subject to regulatory approval, to offer patients with lung cancer a competitive alternative. In addition, and very unexpectedly to some, we have now been able to identify two new cancer settings where PD-1 monotherapy demonstrates profound clinical activity based on our studies. First, advanced glamorous cell carcinoma of the skin, and now advanced basal cell carcinoma.

Baysal cell carcinoma present, another promising opportunity to extend or dermatology portfolio beyond the current squamous cell carcinoma indication.

BCC is the most common cancer in the world.

The only a very small percentage of cases require systemic therapy extremely large incidents of this cancer means that there are still thousands of people with advanced baysal cell carcinoma in need of treatment.

I'd like to frame the significance of these milestones for cancer patients and four regenerons in aggregate. Our studies have now demonstrated the loop tyo is a potent and effective P.D. one motto therapy treatment worry now the potential subject to regulatory approval to offer patients with lung cancer a competitive.

Alternate.

Edition.

And Barry unexpectedly to some.

I have now been able to identify too new cancer settings, where P.D., one monotherapies demonstrates profound clinical activity based on our studies.

First advanced squamous cell carcinoma, the skin and now advanced basis carcinoma skin.

George D. Yancopoulos: Moreover, as Leptaro is establishing itself as a leading PD-1 antibody for monotherapy, it allows us to pursue our strategy of using it in combinations to enhance and extend benefit. For example, we are investigating Leptio in combination studies with our two classes of bispecifics, our CD3 class as well as our CoStim class. That is, we have already initiated a trial combining Leptio with our PSMA CoStim bispecific to try to enhance responsiveness in prostate cancer. We have also initiated a trial combining Leptio with our MUX16 by CD3 bispecific to enhance responsiveness in ovarian cancer. We are also starting trials combining Leptio with our other checkpoint inhibitors and with other collaborative assets. For example, we have initiated a trial combining Leptio with our LAG-3 antibody to try to enhance the responsiveness of first-line melanoma, where we are also combining Leptio with various collaboration assets and vaccines.

Moreover, towers, establishing itself as a leading P.D. one antibody for Monotherapies.

Allows us to pursue our strategy of using it in combinations to enhance and extend benefit. For example, we are investigating reptile in combination studies with our two classes of by specific or C.D. three class as well as our coast him class that is we have already initiated trout, combining reptile with our.

SMH coast in by specific to try to endowed responses in prostate cancer.

We're also initiated a trial combining reptile with our muck 16 by C. three by specific to enhance responsiveness <unk>.

We're also try starting trials combining laptop with our other checkpoint inhibitors and with other collaborative assets. For example, we have initiated truck combining looked tired with our lag three antibody to try to enhance responsiveness first line melanoma, where we are also combined with various colors.

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I should note that or programs are being impacted by the covered 19 crisis in additional future impacts are difficult to predict.

George D. Yancopoulos: I should note that although all our programs are being impacted by the COVID-19 crisis, and additional future impacts are difficult to predict, bi-specific programs, which have been particularly effective, are ones that we are working very hard on to try to continue to enroll. Our potential epidural programs for our CD20 by CD3 bispecific are enrolling in relapsed refractory follicular lymphoma, in relapsed refractory diffused large B-cell lymphoma, and in this setting following CAR T-cell therapy.

Are buys incivek programs.

Which have been particularly affected are ones that we are working very hard on to try to continue to enroll.

Or potentially pirro programs for R.C.D. 20 by C., three by specific or enrolling in relapse <unk> relapse refractory flicking lymphoma.

Relapse refractory diffuse large visa lymphoma and in this setting following car t. cell therapy.

Failure, we anticipate full enrollment over the next year.

George D. Yancopoulos: We anticipate full enrollment over the next year, and I remind you that we have demonstrated very promising initial efficacy and durability in all of these settings. Similarly, our BCMA by CE3 by-specifics for myeloma is continuing to enroll in its proof-of-concept study, where it continues to deliver promising activity, as is our MUX16 by CE3 bispecific for ovarian carcinoma. All together, these are very exciting times for immune oncology here at Regeneron, as we believe we have therapies that are showing important promise as monotherapies, as well as the opportunity to combine and match these therapies as is appropriate to enhance and extend the benefit for additional cancer patients in need. Before handing the call over to Marion, I will conclude with a couple of brief updates on other areas of the pipeline.

And I remind you that we have demonstrated very promising initial advocacy and durability in all of these settings.

Zimmerly RBC may buy c. three by specific.

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Tune into enrollments proof of concept study were continues to deliver promising activity as is our muck 16 by C. three by specific for ovarian carcinoma.

Altogether. These are very exciting times for Immunoncology. Your general as we believe we have therapies that are showing important promise as monotherapies as well as the opportunity to combine in match. These therapies as is appropriate to enhance and extend the bennett for additional cancer patients in neat.

Before handing the call over to Marion, Let me conclude with a couple of brief updates on other areas of the pipeline.

George D. Yancopoulos: We are on track to complete our regulatory submissions for Evanacumab, our AngPTL3 antibody for homozygous familial hypercholesterolemia patients later this year. Recall, in our Phase III trial, ivinacumab reduced LDL, or bad cholesterol, by an impressive 49% in patients not well-controlled with other lipid-lowering treatments, including anti-PCSK9. We are also planning an FDA submission of the data package for Gerritussimax, an antibody for fibrodysplasia ossificans progressiva, in the second half of 2020 following dramatic results showing a 90% reduction in new bone lesion formation and pending confirmation of these data from the second half of the study. We continue to explore the process of our C5 antibody and the potentially game-changing nature of the combination of this antibody with the siRNA program that you are performing in cobaltion with alnilam.

We are on track to complete our regulatory submissions for of inaccurate or H.P.G.L. three antibody for homozygous familiar hypercholesterolemia patients later this year.

Recall in our phase three trial is inaccurate have reduced LDL or bad cholesterol, but impressive 49% impatience not well controlled with other lowering true.

Including anti P.C.S. canines.

We are also planning an F.D.A. submission of the day package for your tests a man.

Or active in a in body for Fibrile dysplasia us the cans progressive in the second half of 2020, following dramatic results showing 90% reduction new bone lesion formation impending confirmation of these data from the second half of the study.

We continue to explore the prospects of R.C., five antibody and potentially game changing nature of the combination of this antibody with the S.I.R. in a program, which were performing in combination with.

George D. Yancopoulos: We continue to move forward with the intent of initiating registration studies over the next 12 months. Finally, the opiate crisis continues, and the need for alternative chronic pain solutions remains. We are making progress with Decinumab, a nerve growth factor antibody, for osteoarthritis pain. We completed enrollment in our Phase 3 studies last year, and we are expecting to see data mid-year. With that, I will turn the call over to Marion.

Continue to move forward with intent on initiating registration studies over the next 12 months.

Finally, the opiate crisis continues in the need for alternative chronic pain solutions remain.

We are making progress with the senior map or nerve growth factor random body for osteoarthritis pain.

Completed enrollment interface, we studies last year.

Expecting to see data mid year.

With that I will turn the call over to marry.

Marion McCourt: Thank you, George. Our business performance in the first quarter reflects continued, healthy, demand-driven growth for our core brands Alia, Leptio, and Depixion. While COVID-19 began to impact our business in the latter half of March, our first quarter results were strong. I'm going to begin with ILEA's performance.

H.U.H.R. business performance in the first quarter reflects continued healthy demands shave increment of our car brands.

Let time and to make sense.

19 began to impact our business in the ladder half of March our first quarter results for strong and going to begin with only a performance.

Marion McCourt: ILEA had an impressive start to the quarter with continued share gains. Global net sales grew 6% year-over-year to more than $1.85 billion, and U.S. net sales grew 9% to $1.17 billion versus the prior year. COVID-19 began to negatively impact ILEA sales, with a greater impact from the pandemic on patients with diabetic eye disease than on patients with wet AMD. There was a sharp decline in overall demand in the last two weeks of March and the first two weeks of April, followed by a sharp rebound in the most recent two weeks. Overall, in the month of April, demand was approximately 15% lower than the same time last year.

Hadn't impressive start to the quarter, which continued share gains global net sales green, 6%, <unk> 1.85 billion, <unk> or 9% to 1.17 billion versus the prior year.

Covered 19.

Impact ideas house with greater impact from the pandemic on patients that diabetic I disease.

On patience with wedding day.

Was a sharp decline in overall demand in the last two weeks of March.

First two weeks of April followed by a sharp rebound in the most recent two weeks overall in a month of April demand was approximately 15% lower than the same time last year or encouraged by the recent rebound although it is difficult to predict future covered 19 in.

Marion McCourt: We're encouraged by the recent rebound, although it is difficult to predict future COVID-19 impacts. Nevertheless, despite these circumstances, we've been extremely impressed with retina specialists' efforts to ensure continuity of patient care. Physicians use ILEA to preserve the patient's vision because of its breadth of indications, dosing flexibility, convenience, and safety. ILEA dosing can be extended up to 12 weeks in appropriate patients, and the recently launched pre-filled syringe offers additional efficiency of care.

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Despite the circumstances meet an extremely impressed with brightness specialist efforts.

Sure continuity patient care.

Preserve their patients vision because of expressive indications.

Inflexibility convenience and safety alia.

Extended up to 12 weeks inappropriate patients and the recently launched pre soap syringe offers additional session C.S. care.

Marion McCourt: Additionally, we have evolved our efforts to support the retinal community through virtual engagement, as well as patient aids to self-monitor vision. We have plans in place to support customers in meeting anticipated higher demand for ILEA once social distancing measures are relaxed. In summary, we're confident that ILEA can navigate through and grow beyond COVID-19. Turning to Libtio, first quarter global net sales were $75 million.

Additionally, we've evolved or efforts to support the retinal community stream virtual engagement as well as providing patients AIDS <unk> self monitor vision, we have plans in place to support customers a meeting anticipated higher demand for idea one social distancing measures I relaxed in some rate, we're confident that l. yet.

Navigate through and grow beyond covet 19.

<unk> Kyle first quarter Global next sales for 75 million in the U.S. sales Street 62 million and we continue to extend the child leadership as the number one systemic treatment for advanced cutaneous squamous cell carcinoma R.C.S.C.C.

Marion McCourt: In the U.S., sales reached $62 million, and we continue to extend Libtio leadership as the number one systemic treatment for advanced cutaneous gray muscle carcinoma, or CSCC. We continue to grow Libtio and CSCC with nearly 65% of CSCC patients who received systemic therapy already being treated with an anti-PD-1 antibody. In addition to growing the market, we're also capturing more of the therapeutic class, as demonstrated by nearly 90% of new PD-1 patients with CSCC receiving Leptio. We're also closely monitoring the impact of COVID-19 on Leptio.

Continue to grow lip tie in C.S.C.C., nearly 65% of C.S.C.C. patients.

Who receives a segment therapy already being treated with an N.T.P.D. one.

In addition to growing the market were also capturing more of the therapeutic class demonstrated by nearly 90% of new P.D., one patients with C.S.C.C. receiving the child.

For US also closely monitoring the impact of Covet 19 on Love Child office visits and chemotherapy administration of decline in general let tile use remained steady and treatment decisions for eligible patients are being made on a case by case basis. Overall, we're proud of our progress what'll child.

Marion McCourt: While office visits and chemotherapy administration have declined in general, Leptio use remains steady, and treatment decisions for eligible patients. Overall, we're proud of our progress with Lutaio. In addition, our team is busy preparing for potential future launches with our collaborator Sanofi in lung cancer and basal cell carcinoma. In 2019, the worldwide anti-PD-1 and PD-L1 market was just over $21 billion. In the U.S. alone, the market for non-small cell lung cancer was $13 billion, $8 billion of which was first line, with the vast majority of sales still coming from Katruda. With more than 200,000 new diagnoses of lung cancer in the U.S. each year, oncologists prefer having a choice in determining the most appropriate treatment for patients. Finally, moving to Dupixent, global net sales in the first quarter were $855 million. In the U.S., net sales reached $679 million, representing 124% growth compared to the prior year.

In addition, our team is busy preparing for potential future launches with our collaborators fantasy in lung cancer and Baysal cell carcinoma in 2019 to worldwide N.T.P.D., one M.P.D.L. one market much just over 21 billion.

US alone and that 2019 market in non small cell lung cancer was 13 billion 8 billion of which was first line with the vast majority of sales still coming from Katrina with more than 200000, new diagnoses of lung cancer in the USA chair and colleges prefer having a choice.

Determining the most appropriate treatment for patients.

Finally, moving to depiction global net sales in the first quarter for 855 million in the U.S. net sales read 679 million, representing 124% growth compared to the prior year, we continue to grow prescribing across all indications, including native brand patients.

Marion McCourt: We continue to grow prescribing across all indications, including new to brand patients. In the first quarter, we did not see a material impact of COVID-19 on Dupixent sales. In the month of April, the rate of new patient starts on Dupixent was impacted due to COVID-19. Dupixent has several unique competitive advantages that assist physicians in today's challenging environment. It can be administered at home, and it does not require laboratory analysis to initiate most new patients.

In the first quarter, we did not see a material impact of public 19 on depiction sales.

In month of April the rate of new patients start on D.P. accent was impacted due to cover 19 depiction has several unique competitive advantages and assist physicians and today's challenging environment. It can be administered at home. It's just not require laboratory analysis to initiate most new patients.

Depiction is not an immunosuppressant expected approval of the auto injector in June or provide additional convenience for product administration. It habit dermatitis remains a significant growth driver for depiction we've expanded prescribing across both moderate in severe disease and eligible treatment population continues.

Marion McCourt: And Dupixent is not an immunosuppressant. The expected approval of the autoinjector in June will provide additional convenience for product administration. Atopic dermatitis remains a significant growth driver for Dupixent, and we've expanded prescribing across both moderate and severe disease. And the eligible treatment population continues to grow. In the first quarter of 2019, Dupixent was approved for adolescents. And we look forward to the BDUFA decision on 6 to 11-year-olds, targeted towards the end of May.

The girl.

In the first quarter 2019, you picks it was approved in adolescence, and we look forward to the bit gives a decision for six to 11 year olds targeted towards the end of May we've seen rapid uptake of detection in adolescence since its approval largent originally due to physician experience an older populations, which provides comfort.

Efficacy and safety in these younger patients an asthma depicts and continues to outperform other recent biologic launches we've seen limited volume impact from cover 19, particularly since medications such as depicts are vital for patients to maintain respiratory function while in.

Marion McCourt: We've seen rapid uptake of Dupixent in adolescents since its approval, largely due to physician experience in older populations, which provides comfort in its efficacy and safety in these younger patients. In asthma, Dupixent continues to outperform other recent biologic launches. We've seen limited volume impact from COVID-19, particularly since medications such as Dupixent are vital for patients to maintain respiratory function. However, while in the early days, the asthma DTC campaign is already generating significant patient interest. Finally, our commercial efforts in chronic rhinocytis with nasal polyps continue to contribute meaningfully to the brand. Patients have been initiated on DEPIXENT regardless of prior surgery since approval, and during the COVID-19 pandemic, there is an even greater need for DEPIXENT in these patients due to the limited availability of elective nasal polyp surgery. Taken together, we remain committed to realizing the tremendous growth potential of DEPIXENT through expanded indications, age groups, and geographies. In closing, despite the current circumstances, our brands remain resilient, we continue to execute on our strategy, and we are working diligently to meet the evolving needs of our customers and patients. I'll turn the call over now to Bob.

Early days the asthma T.T.C. campaign is already generating significant patient interest.

Finally, our commercial efforts and chronic whiny saddest with nasal polyps continue can contribute meaningfully to the brand patients had been initiated on depiction regardless of prior surgery since approval and during the coded 19 pandemic.

Is an even greater need for depiction in these patients due to the limited availability of elective nasal polyp surgery.

Taken together, we remain committed to realizing that tremendous growth potential depicts it.

True expanded indications age groups and geography is enclosing despite the current circumstances are branch remain resilient, we continue to execute and our strategy and are working diligently to meet the evolving needs of our customers and patience I'll turn to call over now to Bob.

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The first quarter 2020, Regeneron delivered solid results on both the top and bottom line. Despite coded 19, beginning to impact or business operations and a lot or half of March.

Today I will first briefly discuss the first quarter results and then conclude with our 2020 guides.

Effective January 120, 20, we implemented changes tour accounting presentation related to certain reimbursements and other payments from collaborators.

Such or first quarter 2020, incomparable 2019 financial statements have been prepared under the new accounting presentation. We made these changes to better reflect the nature of the company's revenues or in costs incurred pursuant to arrangements with collaborators.

Robert E. Landry: Thanks, Marion. For the first quarter of 2020, Regeneron delivered solid results on both the top and bottom lines, despite COVID-19 beginning to impact our business operations in the latter half of March. Today I will first briefly discuss the first quarter results and then conclude with our 2020 guidance. Starting January 1, 2020, we implemented changes to our accounting presentation related to certain reimbursements and other payments from collaborators. As such, our first quarter 2020 and comparable 2019 financial statements have been prepared under the new accounting presentation. We made these changes to better reflect the nature of the company's revenues earned and costs incurred pursuant to arrangements with collaborators. Importantly, these changes provide a simplified presentation of our financial results. They do not impact income from operations, income taxes, net income, or net income per cent. For more information regarding these changes, please refer to the slide presentation in FAQ on the Regeneron Investor Relations website. Turning now to the results.

Importantly, these changes providing simplified presentation of our financial results. They do not impact income from operations income taxes.

Income or net income per share.

For more information regarding these changes please refer to the slide presentation in F.A.Q.

Iran Investor Relations website.

Now to the results.

First quarter 2020 revenues group, 33% Euro per year to 1.83 billion driven by continued growth of both I live in <unk> as well as higher scientific collaboration revenues as a result of strong performance for more depiction franchise.

Non gap diluted net income per share crew, 48% euro per year $6.60 on non gap net income of 771 million.

Since Marion discussed or U.S.I. Leo results I will start with our Bayer inside a few collaboration.

Starting with the bare collaboration <unk> product sales, which are reported to us by bear where 682 million representing growth of 2% on a recorded basis compared to the prior year total bear collaboration revenue was 281 million increase of 7%.

Robert E. Landry: First quarter 2020 revenues grew 33% year-over-year to $1.83 billion, driven by continued growth of both ILEA and LIBTIO, as well as higher Sanofi collaboration revenues as a result of strong performance from our DEPIXENT friends. Non-gap diluted net income per share grew 48% year-over-year to $6.60 on non-gap net income of $771 million. Since Marion discussed her U.S. ILEA results, I will start with our Bayer and Sanofi collaboration. Starting with the Bayer collaboration, ex-U.S. ILEA net product sales, which are reported to us by Bayer, were $682 million, representing growth of 2% on a reported basis compared to the prior year. Total Bayer collaboration revenue was $281 million, an increase of 7%. We recorded $254 million for our share of net profits from ILEA sales outside the U.S. Total Sanofi collaboration revenue, which under the new accounting presentation consists of our share of antibody profits and reimbursements for the manufacturing of commercial supplies, was $247 million in the first quarter.

We recorded 254 million for our share of net profits from my Leo sales outside the U.S.

Total Santa Fe collaboration revenue, which onto the new accounting presentation consists of our share of anybody profits and reimbursements for the manufacturing of commercial supplies was 247 million in the first quarter or share of the profits from the commercialization of non I owe any bodies was 171 million compared to a loss.

28 million and the prior period, driven by hired to picks and profits.

Effective April 120, 20, we finalize the plan prevalent restructuring with Santa feet in the U.S. Regeneron, we'll have sole responsibility for probably lit and we have begun recording that product sales as of April 1st.

Outside the U.S. on if you will have sole responsibility for probably and we'll pay regeneron, 85% rural T. on such net product sales, which we were record in other revenue as for Kevzara Regeneron insanity continue to assess potential terms of this restructuring following the recently launched political program evaluating kevzara in.

Hospitalized patients with coded 19.

Moving toward our expense space, and starting with R. and D. non gap R. and D. increased 23% euro per year to 527 million driven by advancements in or earlier stage pipeline higher headcount ended increasing clinical manufacturing activities.

Robert E. Landry: Our share of the profits from the commercialization of non-Io antibodies was $171 million, compared to a loss of $28 million in the prior period, driven by higher depicts in profit. Additionally, effective April 1, 2020, we finalized the planned Pralulent restructuring with Sanofi. In the U.S., Regeneron will have sole responsibility for Pralulent, and we have begun recording net product sales as of April 1. Outside the U.S., Sanofi will have sole responsibility for Praline, and will pay Regeneron a 5% royalty on such net product sales, which we will record in other revenues.

Next first quarter 2020, non gap as Jean expense increased 27 per cent euro per year to 307 million Euro over your increase was driven by higher headcount in commercial investments to support the continued growth of or a business.

First quarter 2020, non gap cost of collaboration contract manufacturing was 139 million compared to 101 million and the first quarter 2019 Euro over your increase in C.O.C.M. was primarily due to manufacturing costs associated with higher global sales a depiction in manufacturing costs in connection with or BARDA Bola agreement.

Robert E. Landry: As for Kevzara, Regeneron and Sanofi continue to assess potential terms of this restructuring following the recently launched clinical program evaluating Kevzara in hospitalized patients with COVID-19. Moving to our expense base and starting with R&D. Non-GAAP R&D increased 23% year-over-year to $527 million, driven by advancements in our earlier stage pipeline, higher headcount, and an increase in clinical manufacturing activity. Next, first quarter 2020 non-GAAP SG&A expense increased 27% year-over-year to $307 million. The year-over-year increase was driven by higher headcount in commercial investments to support the continued growth of our First quarter 2020 non-gap cost of collaboration and contract manufacturing was $139 million compared to $101 million in the first quarter of 2019. The year-over-year increase in COCM was primarily due to manufacturing costs associated with higher global sales at PIXEN and manufacturing costs in connection with our BARDA-EBOLA agreement. Finally, we introduced a new line item called Other Operating Income and Expense this quarter.

Finally, we introduced to new line item called other operating income inexpensive. This quarter. This line item is located within expenses in primarily consists of the recognition of upfront payments in development milestones that were initially differed in our recognized over time from our collaborators Santa fee Tebow.

Mitsubishi <unk> for the first quarter 2020, we recorded other operating income of 40 million compared to income of 57 million recorded in the first quarter of 2090.

Turning out of taxes that nongaap effective tax rate was 9.5% in the first quarter of 2020 compared to 16% in the first quarter 2019 Euro.

Kline and the non gap effective tax rate was due to increased tax benefits associated with stock option exercises in the first quarter of 2020.

Shifting out of cash flow into balance sheet.

For the first quarter 2020, Regeneron generated 528 million and free cash flow in the quarter, we've repurchased 273 million.

Dollars worth of shares an open market transactions, the Pacers share repurchases slowed considerably toward the end of the first quarter 2020, given the recent share price appreciation or fully diluted share count that we've reports were given quarter is highly sensitive to the average stock price if the average stock price for the second quarter is similar to the current stock price level.

We would estimate that are weighted average share count used for calculating nod gap bps for the second quarter will be in the range of 121 223 million shares.

Robert E. Landry: This line item is located within expenses and primarily consists of the recognition of upfront payments for development milestones that were initially deferred and are recognized over time from our collaborators, Sanofi, Teva, and Mitsubishi Tanabe. For the first quarter of 2020, we recorded other operating income of $40 million compared to income of $57 million recorded in the first quarter of 2019. Turning now to taxes, the non-GAAP effective tax rate was 9.5% in the first quarter of 2020 compared to 16% in the first quarter of 2019. The year-over-year decline in the non-GAAP effective tax rate was due to increased tax benefits associated with stock option exercises in the first quarter of 2020.

Finally to the balance sheet, we ended the quarter with cash 'em marketable securities of 7.2 billion.

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Spend a few moments to discuss the financial outlook for the remainder of the year.

We assume that the Cogan 19 impact on our business will peak in the second quarter 2020, we anticipated recovery as to your progress as economies gradually reopen social distancing guidelines are relaxed doctor in hospital visits return the prior levels.

From a supply chain in manufacturing perspective, Regeneron has historically maintained high levels of inventory in the event of a prolonged impact or manufacturing and production capabilities. Currently we see minimal disruption store supply chain in our manufacturing activities and we have adequate supply of commercial product on hand to meet.

Robert E. Landry: Shifting now to cash flow and the balance sheet, for the first quarter of 2020, Regeneron generated $528 million in free cash flow. In the quarter, we repurchased $273 million worth of shares in open market transactions. The pace of share repurchases slowed considerably toward the end of the first quarter of 2020, given the recent share price appreciation.

Demand.

Or 2020 annual financial gains reflects or latest assessment over a business in this current environment with limited precision certain elements of our spend will be dictated by the continued severity and linked to the covert 19 impact in our efforts associated with Xsara in or Sars.

You will be too antibody cocktail.

These factors may materially impact our guidance, we will assess carefully whether further updates tour guides maybe warranted.

Now moving toward 2020 financial guard guidance, and starting with R. and D., we forecast or 2020, non gap R. and D. expenses, the being the range of 1.9 to 2.4 billion.

Robert E. Landry: Our fully diluted share count that we report for a given quarter is highly sensitive to the average stock price. If the average stock price for the second quarter is similar to the current stock price levels, we would estimate that our weighted average share count used for calculating non-GAAP EPS for the second quarter will be in the range of 121 to 123 million shares. And finally, to the balance sheet, we ended the quarter with cash and marketable securities of $7.2 billion, with minimal debt.

We are continuing to invest on a pipeline and research capabilities, which remained critical to the long term growth of the business or in college, you pipeline continues to grow and as conditions allow we intend to advance programs through development. Additionally, we are funding external partnership obligations as jointly developed molecules are rapidly advancing.

Or are indeed guidance also includes the portion related tour Cogut 19 activities, where we will be reimbursed at least in part by border.

Robert E. Landry: Now, I'd like to spend a few moments discussing the financial outlook for the remainder of the year. We assume that the COVID-19 impact on our business will peak in the second quarter of 2020. We anticipate a recovery as the year progresses, as economies gradually reopen, social distancing guidelines are relaxed, and doctor and hospital visits return to prior levels. From a supply chain and manufacturing perspective, Regeneron has historically maintained high levels of inventory in the event of a prolonged impact on our manufacturing and production capabilities. Currently, we see minimal disruptions to our supply chain and our manufacturing activities, and we have an adequate supply of commercial product on hand to meet demand.

Unlike our R. and D. reimbursements from collaboration which are needed in the yard the expense line item under the new accounting presentation.

These reimbursements from board it will continue to be recorded in other revenue next to S.G.N.A., we forecast or 2020 non get this gene expenses to be in the range of 1.19 to 1.29 billion. We are continuing to invest for product groups now and wants to cope with 19 impact debates.

Leah we are continuing to make investments in diabetic eye disease.

Tiled launched preparations are underway for anticipated launches baysal sell nonsmall, so lung cancer.

Starting this year, we are providing guidance for Cogs in C.O. seeing him for Cogs, We forecast 2020, non gap expenses to being the range of 295, the 355 million primarily comprised of U.S.I. Leah.

Robert E. Landry: Our 2020 Annual Financial Guidance reflects our latest assessment of our business in this current environment with limited precision. Certain elements of our spend will be dictated by the continued severity and length of the COVID-19 impact on our efforts associated with Kevzara and our SARS-CoV-2 vaccine. COVID-19 Antibody Cocktail

<unk> in U.S., probably like manufacturing costs in the payment to Santa P. for 50% of the gross margin associated with you whistle title.

C.O.C.M., we forecast 2020, non gap expenses to be in the range of 600 to 700 million primarily comprised of global to picks in global Kevin Czar <unk> <unk> in Regeneron D.B. three manufacturing costs. As a reminder, we are reimburse receive LCM costs.

Robert E. Landry: These factors may materially impact our guidance, and we will assess carefully whether further updates to our guidance may be warranted. Now moving to our 2020 financial guidance and starting with R&D, we forecast our 2020 non-GAAP R&D expenses to be in the range of $1.9 to $2.04 billion. We are continuing to invest in our pipeline and research capabilities, which remain critical to the long-term growth of the business. Our oncology pipeline continues to grow, and as conditions allow, we intend to advance programs through development. Additionally, we are funding external partnership obligations as jointly developed molecules are rapidly advancing, or R&D guidance, also includes the portion related to our COVID-19 activities where we will be reimbursed at least in part by BARDA. However, unlike R&D reimbursements from collaborations, which are netted in the R&D expense line item under the new accounting presentation, these reimbursements from BARDA will continue to be recorded in other revenue.

Reimbursements are recognized within the Santa fee in Bayer collaboration revenue lines and other revenues reimbursements should closely approximate seals seeing them expenses for quarterly reporting periods subject to timing and other considerations.

For the new line item of operating income an expense we expect this to be in the range of 175 to 205 million of income you share.

And finally to tax we anticipate or 2020 non gap effective tax guidance to be in the range of 12% to 14%.

In conclusion, we had a solid start to the year. Despite initial impacts from coded 19 or balance sheet increasingly diversified commercial portfolio and robust pipeline enable regeneron to withstand the impacts of cold at 19, while making prudent investments in executing a meaningful near term opportunities to position.

<unk> for sustained long term growth with that I'd like to turn the call back to Justin. Thank you Bob Crystal that concludes our prepared remarks, we'd now like to open the call for Q. and a.

Robert E. Landry: Next to SG&A, we forecast our 2020 non-GAAP SG&A expenses to be in the range of $1.19 to $1.29 billion. We are continuing to invest in product growth now and once the COVID-19 impact abates. For ILEA, we are continuing to make investments in diabetic eye diseases. For Liptio, launch preparations are underway for anticipated launches in basal cell and non-small cell lung cancer.

The word that we have more than 20 colors in the queue. So to ensure that we are able to address as many as possible. We will answer one question from each color before moving to the next please go ahead crystal.

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The question at this time.

Press to star in the number one key on your touch tone telephone. If your question has been answered or you was to remove yourself from the queue. Please press the pound key.

Robert E. Landry: Starting this year, we are providing guidance for COGS and COCM. For COGS, we forecast 2020 non-GAAP expenses to be in the range of $295 to $355 million, primarily comprised of U.S. ILEA, U.S. Leptio, and U.S. Pralulent manufacturing costs in the payment to Sanofi for 50% of the gross margin associated with U.S. Leptio. At COCM, we forecast 2020 non-GAAP expenses to be in the range of $600 to $700 million, primarily comprised of global to PIXEN, global Kevzar, XUS ILEA, XUS Pralulent, and Regeneron EB3 manufacturing costs. As a reminder, we are reimbursed for COCM costs. Reimbursements are recognized within the Sanofi and Bayer Collaboration Revenue Lines and other revenues. However, investors should closely approximate COCM expenses for quarterly reporting periods subject to timing and other considerations.

First question comes from the line of Evan.

From credit.

Hi, all thank you for taking my question thinking grass on the progress. This quarter. Thank you also for your effort combating the pandemic so with data from both the front line long trial last week and Baysal cell carcinoma. Today can you expand as to what's next for your oncology franchise. How do you plan on competing with the standard of care in front and the front lawn lungs setting.

More broadly across tumor types amenable to Iowa therapy.

Oh, so George.

And I guess that.

Most importantly, as we noted.

The loan.

Field is dominated by.

Yeah.

Leading anybody that has produced the most impressive data.

We are very excited that our motto therapy trial has delivered data that looks very impressive in terms of the overall survival endpoint.

And we have an ongoing combination traveled chemotherapy as well that we're excited about having read out over the coming year or so and so I think that this is going to position as well.

In such a large opportunity where physicians and patients are looking for alternatives to have an agent that has such profound activity as amano therapy, but in addition, we have all these combination programs that I was referring to we have we believe one of the most exciting home grown pipelines.

Robert E. Landry: For the new line item of operating income and expense, we expect this to be in the range of $175 to $205 million of income this year. And finally, taxes. We anticipate our 2020 non-GAAP effective tax guidance to be in the range of 12 to 14 percent. In conclusion, we had a solid start to the year despite initial impacts from COVID-19. Our balance sheet, increasingly diversified commercial portfolio, and robust pipeline enabled Regeneron to withstand the impacts of COVID-19 while making prudent investments and executing on meaningful near-term opportunities to position Regeneron for sustained long-term growth.

Of additional agents that we could combine to not only enhanced the activity in these settings, where the P.D. one monotherapies already actor and also to extend to new settings, and new indication such as I mentioned, whether it be prostate cancer or.

Ovarian cancer others. We're right now the activity is is is now what we would want so I think that we put ourselves into a pretty exciting position, where we have some of the most exciting agents with.

Robert E. Landry: With that, I'd like to turn the call back to Justice. Thank you, Bob. Crystal, that concludes our prepared remarks. We'd now like to open the call for Q&A. Just a word that we have more than 20 callers in the queue, so to ensure that we are able to address as many as possible, we will answer one question from each caller before moving to the next. Please go ahead, Crystal.

Identify profound clinical activity as monotherapies, but we now have the opportunity to mix and match. These as is appropriate.

To enhance and extend the activity. So we're very excited about the ontology situation.

Yeah, and just to add on the commercial cited Marion can chime in you know obviously, we collaborated with set a fee where we take the lead in the United States. They take lead outside the United States, but we work together with them and and this diseases dominated by lung cancer, maybe maybe a little bit about the numbers incidents prevalence what kind of marketplace, we going into.

Operator: Ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your touch-tone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Your first question comes from the line of Evan Seigerman from Credit Suisse.

Yes, so lung cancer is a disease or the very large instead in population of more than.

200000 newly diagnosed patients each year. So we do think there's tremendous opportunity and know that on colleges prefer having a choice and determining.

Evan Seigerman: Hi all, thank you for taking my questions and congratulations on the progress for this quarter. Thank you also for your efforts in combating the pandemic. So with data from both the frontline lung trial last week and basal cell carcinoma today, can you expand as to what's next for your oncology franchise? How do you plan on competing with the standard of care in the frontline lung setting and more broadly across tumor types amenable to iotherapy? Well, this is too much information.

Treatment for their patients. So we're excited about the data and we'll look carefully beside the fee on lunch preparedness and certainly fulfilled a commercial team that has extensive experience in competitive launches. We look forward to this opportunity. If in fact, we have an approval for lung and for Baysal cell.

Thanks and next question.

Your next question comes.

Jeffrey porches with with S. to Phoebe.

Thank you very much.

<unk>.

George D. Yancopoulos: Um, and I guess that most importantly, as we noted, the lung..., field is dominated by leading antibodies that have produced the most impressive data. We are very excited that our monotherapy trial has delivered data that looks very impressive in terms of the overall survival endpoint, and we have an ongoing combination trial with chemotherapy as well that we're excited about having read out over the coming year or so. And so I think that this is going to position us well for such a large opportunity where physicians and patients are looking for alternatives to have an agent that has such profound activity as monotherapy. But in addition, we have all these combination programs that I was referring to. We believe we have one of the most exciting homegrown pipelines of additional agents that we could combine to not only enhance the activity in these settings where the PD-1 monotherapies are already active but also to extend to new settings and new indications, such as I mentioned, whether it be prostate cancer or ovarian cancer or others, where right now the activity is not what we would want. So I think that we've put ourselves into a pretty exciting position where we have some of the most exciting agents with identified profound clinical activity as monotherapies, but we now have the opportunity to mix and match these as is appropriate uh... to enhance and extend the activity, so we're very excited about oncology

Surprisingly strong quarter, but also will the progress on the pipeline.

George.

We haven't had a lot of access to talk to you about.

Programs.

But could you just.

Expound little bit on the backup program, what his nature is and related question.

What do you view as the risk of.

Both 80 and also.

In some way contributing outrageously to the inflammatory syndrome in Thailand, but this disease.

Alright, Yeah. Those are those are great questions. So we were able to generate because we have these very robust platforms. Both the ability to get fully human antibodies from our genetically humanize mouse model as well as from recovering humans, we generated a collection of thousands.

Thousands of antibodies.

Getting many antibodies that really were at the top and historically at the at the best level of binders and blockers.

Anti viral neutralizes that you've ever seen based on literature in the history and so what we did was we simply selected.

Several cocktails of the best antibodies, where we put them together and we created our initial cocktail and a backup cocktail just in case for some reason.

Something goes wrong with the initial cocktail so they're actually quite similar it's just a different collection of antibodies for the backup as well as for the primary now we think that based on the history of treating.

George D. Yancopoulos: Yeah, and just to add on the commercial side, maybe Marion can chime in, you know, obviously we collaborate with Sanofi where we take the lead in the United States, they take the lead outside the United States, but we work together with them, and this disease is dominated by lung cancer. Maybe Marion could give a little bit about the numbers, the incidence, prevalence, and what kind of marketplace we're going into.

Infectious disease in viral diseases with highly potent neutralizing antibodies the risks of things such as antibody dependent enhancement and so forth are actually quite limited you actually see these for example in certain classes or viruses.

The flavor you viruses, the Dingee type viruses.

And so forth in particular, but that's because of the biology to the viruses there with most other viruses. When you have highly potent neutralizing antibodies. These risks are mitigated we do have.

Marion McCourt: Yes, lung cancer is a disease with a very large incident population of more than 200,000 newly diagnosed patients each year. So we do think there's tremendous opportunity and know that oncologists prefer having a choice in determining treatment for their patients. So we're excited about the data, and we'll look more carefully with Sanofi on launch preparedness and certainly have built a commercial team that has extensive experience in competitive launches. We look forward to this opportunity if, in fact, we have an approval for lung and for basal cell.

In addition to our backup collection of antibodies, we do also have.

Oriented cocktails made with what we call <unk> dealt constant regions, which would completely mitigate against that possibility.

But for the current approaches that we're taking we're going to be going forward with the the fully armed antibodies because we think the risks of 80 with very potent neutralizing antibodies is actually quite low.

Operator: Thanks, Evan. Next question?

Operator: Your next question comes from the line of Jeffrey Porches with SVB Larynx.

So I think that you know the history of anti viral antibodies are experienced the way they worked our own antibodies and other programs most notably in a bowl we think that there's a very significant chance that these specifically designed very potent utilizing antibodies, we all have a significant impact.

Jeffrey Porches: Thank you very much and congratulations on both the surprisingly strong quarter but also all the progress on the pipeline. We haven't had a lot of access to talk to you about the COVID programs, but could you just expound a little bit on the backup program, what its nature is, and the related question of what you view as the risk of both AD and also of the antibodies in some way contributing adversely to the inflammatory syndrome in the

The disease, we think that.

Great chance that they can be very powerful prophylactic and preventive agents.

All those things that they can treat patients who are already symptomatic with disease and we don't think that right now there's any evidence that suggests that the antibody response is what's contributing to the inflammatory sponsors in the long.

George D. Yancopoulos: https://www.youtube.com.uk

George D. Yancopoulos: Alright, yeah, those are great questions. So, what we were able to generate, because we have these very robust platforms, both the ability to get fully human antibodies from our genetically humanized mouse model, as well as from recovering humans, we generated a collection of thousands and thousands of antibodies. We got many antibodies that really were at the top end, historically at the best level of binders and blockers and antiviral neutralizers that you've ever seen based on the literature and the history. And so what we did was we simply selected several cocktails of the best antibodies, where we put them together, and we created our initial cocktail and a backup cocktail just in case, for some reason, something goes wrong with the initial cocktail.

And as of course has has already been seen in describing disease.

Majority patients do recover and their recovery is coincidence with their producing.

Vile responses. So altogether I think there's a lot of reason to have a lot of hope that this approach really has a chance to make a difference as we said both in prophylactic treatment, but also in treating symptomatic patients.

Sex jokes, where my question.

There next question comes from the line of Cory.

From J.P. Morgan.

Hey, good morning.

Question just to follow up on just a question on the on the cover 19 fraud curious how you're thinking about the clinical trial designs for your antibody cocktail both promote prophylactic I'll standpoint, as well as a therapeutic in on the ladder do you plan to either go head to head or on top of Grandad severe if you run initial study than a hospitals.

George D. Yancopoulos: So they're actually quite similar; it's just a different collection of antibodies for the backup as well as for the primary. Now we think that based on the history of treating infectious diseases and viral diseases with highly potent neutralizing antibodies, the risks of things such as antibody-dependent enhancement and so forth are actually quite limited. You actually see these, for example, in certain classes of viruses, the flaviviruses, the dengue-type viruses, and so forth in particular, but that's because of the biology of the virus. With most other viruses, when you have highly potent neutralizing antibodies, these risks are mitigated. We do have, in addition to our backup collection of antibodies, we also have our antibody cocktails made with what we call uber-stealth constant regions, which would completely mitigate that possibility.

Thank you.

Well.

Planning on doing three sets of trials.

In the prophylactic or prevention setting in people who are at high risk.

In early treatment that his patients who are not at the level that they would be normally hospitalized patients who are identified the of symptomatic. If they do gurnee are they are sent home, but they don't need oxygen support.

I have a significant number of them do develop more serious disease and then have to return to the hospital. So the idea would be to stop the disease in those individuals and stop the progression in the need from them going back to the hospital and then we're also going to go to the hospitalized setting.

Very similar to what we're doing with Kim Xsara.

And where the room disappear data has read out so certainly.

George D. Yancopoulos: But for the current approaches that we're taking, we're going to be going forward with the fully armed antibodies because we think the risks of ADE with very potent neutralizing antibodies are actually quite low. So I think that, you know, the history of antiviral antibodies, our experience, the way they worked, our own antibodies in other programs, most notably in Ebola, we think that there's a very significant chance that these specifically designed, very potent neutralizing antibodies will have a significant impact on the disease. We think that...

The only the only setting where it would be on top of an existing standard of care potentially would be in the late treatments setting we would certainly be going on top of standard of care, there, whether it be room deserving or or maybe we'll see whether there's data from other regions by that time as well in that prophylactic setting there's no need and there's also.

No other standard of care and in the same thing early treatment and I would remind you once again based as I said our experience in other programs and most notably a good example is the abode program.

Earlier that one treats.

The better one does.

Operator: There's a great chance that they can be very powerful prophylactic and preventive agents. But we also think that they can treat patients who are already symptomatic with... And we don't think that right now there's any evidence that suggests that the antibody response is what's contributing to the inflammatory responses in the lung. And as, of course, as has already been seen and described in the disease, the majority of patients do recover, and their recovery is coincident with their producing viral responses. So, altogether, I think there's a lot of reason to have a lot of hope that this approach really has a chance to make a difference, as we said, both in prophylactic treatment and also in treating symptomatic patients. Thanks, Jeff, for your questions.

Remind too early in the disease for Bola, which is obviously a much more.

Lethal disease was much higher levels.

Of severe disease and death.

To say more than 90% of the patients. When we went with early treatment. So I think that there's a lot of reason to think that in this setting. These sorts of antibodies both in the prophylactic setting and in the early teens and you can have really profound.

Benefits on their own.

Thank you for the question core next.

Your next question come from the line of Tim Anderson from Wolf Research.

Thank you very much on your antibiotic cocktail I'm wondering if you think.

Actions with severe.

So we kind of set the bar for other companies in terms of what they may be expected to do specifically in terms of giving away some portion of initial.

Corey Kasimov: Thanks for my question.

George D. Yancopoulos: Your next question comes from the line of Corey Kasimov from J.P. Morgan.

Therapy free at the outset.

Operator: Hey, good morning guys. Thank you for the question. Just to follow up on Jeff's question.

Thank you.

When you want to take that.

Well.

Yes, hi, sorry.

Timothy Minton Anderson: Jeff's question on the COVID-19 front. Curious how you're thinking about the clinical trial designs for your antibody cocktail, both from a prophylactic standpoint as well as from a therapeutic point of view. And on the latter, do you plan to either go head to head or on top of remdesivir if you run initial studies in a hospital setting? Thank you.

We've spent all of our energy right now focused on getting the technical success that George should describe that we in that we hope to see and in parallel we have been working to clear.

Factoring capacity you know New York plants, so that we can make it a large scale, we hope to be able to have a couple hundred thousand doses by the end of the summer and then continue to.

Len Schleifer: Well, we are planning on doing three sets of trials in the prophylactic or prevention setting in people who are at high risk, uh... in early treatment that is patients who are not uh... at the level that they would be normally hospitalized the patients who are identified as symptomatic if they do go to an ER they are sent home uh... but they don't need oxygen support uh... however significant number of them do develop more serious disease and then have to return to the hospital so the idea would be to stop the disease in those individuals and stop the progression in the need for them going back to the hospital and then we're also going to go to the hospitalized setting uh... very similar to what we're doing with Kibsara uh... and where the remdesivir data has uh... read out so certainly uh... the only setting where it would be on top of an existing standard of care potentially would be in the late treatment setting we would certainly be going on top of uh... standard of care there whether it be remdesivir or maybe we'll see whether there's uh... data from other agents by that time as well in the prophylactic setting uh... there's no need and there's also no other standard of care uh... and in the same thing in the early treatment and I would remind you once again that based as I said our experience in other programs and most notably a good example is the Ebola program the earlier that one treats uh... the better one does uh... and I remind you early in the disease for Ebola which is obviously a Lethal disease with much higher levels of severe disease and death, we were able to save more than 90% of the patients when we went with early treatment. So I think that there's a lot of reason to think that in this setting, these sorts of antibodies, both in the prophylactic setting and in the early treatment setting, can have really profound benefits on their own. Thank you for the question.

Factored from there in terms of pricings donations.

Values and all that sort of stuff.

That's just got to come down the road.

Thank you.

X. question.

Your next question comes from the line of running from Bernstein.

Good morning on Beckwith eight my question I want to go back to leave.

Yeah.

I hear you buy.

He wanted to have it joy in model therapy.

Between two died and the second grader.

The question is why.

Kyle the key to it I think you've got a product you, which is just to make the point few years.

Extensively.

Can you just share with that in your data is are there.

In the trial yet.

They were.

Should refer.

Get rid of what is your marketing argument here and I stopped and I didn't want to thank you all the African making.

Genius. Thank you my peers you.

Thanks, Thanks trying to Clinton.

Early for us to making it a comparative statements.

Literally just recently got the the good news from the data monitoring committee that we met.

With highly statistical significance as George described survival, we've got a lot more data to go we've got a lot more studies to look at it's not just one study it's not just across study comparison, there's going to be a lot more that goes into this and we'll just have to see how this evolves, but the history of the industry.

Quickly is that you know if there's just a couple of competitors you know.

Have to remember that the size of this market last year was about $22 billion of which about 70 or 75% was lung cancer and that was largely driven by construed as sales. So there's a pretty big opportunity to have some important alternatives.

Operator: Thank you for the question, Corey. Next.

Renee Gao: Your next question comes from the line of Tim Anderson from Wolfe Research.

Len Schleifer: Thank you very much. On your antibody cocktail, I'm wondering if you think Gilead's actions with Remdesivir are good or bad. Len, do you want to take that?

And you just have to wait I'm sorry.

See how this all the vowels and we will this out.

Yeah. Thanks running next question.

Your next question comes from the line of Chris Raymond.

Hi per cent.

Operator: The Bulletproof Executive, 2013

You know back to the end about a cocktail I guess, so you know George you know a lot of folks I guess close to the F.D.A. and maybe some with I'll surely loud voice on on these matters.

Operator: Yes, hi. Sorry, Flynn.

Len Schleifer: We've spent all of our energy right now focused on achieving the technical success that George described and that we hope to see. And, in parallel, we have been working to clear manufacturing capacity in our New York plants so that we can make it at large scale. We hope to be able to have a couple hundred thousand doses by the end. Fair Values and all that sort of stuff that's just got to come down the road.

Keep talking about at least one of the therapies one of the antibody therapy system development being available as early as this fall.

So I guess it maybe just talk about how how is that possible you know from a clinical development standpoint, and especially in light of the the program. You just described George with the three different settings.

Operator: Thank you. Next question.

When there's something that's even even under an emergency you thought use authorization.

Operator: Your next question comes from the line of Renee Gao from Bernstein.

Available how to you how to conduct that thanks.

Yaron Worker: Thank you for taking my question. I want to go back to Lib-Ti or non-small cell lung cancer. I hear you about a physician wanting to have a choice in monotherapy between Keytruda and another product. The question is, why should they choose Lib-Ti over Keytruda? Essentially, you've got a product here which is, just to make the point, a few years old and the standard of care, used extensively. Can you just share with us the elements of the data you're seeing from the trials which suggest that there is any group of patients where physicians should prefer Lib-Ti over Keytruda? What is your marketing argument here? And before I stop that, I just want to thank you for all the efforts you're making against COVID-19, just adding to my peers here.

Well, yeah, I think that Israel, great questions, where an unprecedented times I think that the.

Urgency in the collaborative spirit between regulators between medical institutions between companies.

Has never been seen before and also our our commitment to this is something we've sort of done it before but now we're trying to take it to the next level. So we are planning as we said in June two simultaneously initiate trials Indic three settings that we're actually talking about we are thinking.

Of ways to synergize between the three classes of trials that we're talking about and we are hoping I mean this is going to depend on a lot of factors in his I've see a lot of risk since concerns whether this can be done since it hasn't ever been done before but we are really hoping that we'll be able to not only initiate these studies, but able within.

Len Schleifer: Thanks. Thanks, Ron. It's Len.

Len Schleifer: It's way too early for us to be making any comparative statements. We literally just got the good news from the Data Marketing Committee that we met with highly statistical significance, as George described survival. We've got a lot more data to go. We've got a lot more studies to look at. It's not just one study. It's not just a cross-study comparison.

A month or two two perhaps if these agents are working as well as we might hope they would work as well as for example, some of the precedent sent by a bowl of suggested the might work that we might within that month or to be getting data.

If we were to get data within this sort of time frames.

Describes we have already committed at risk to manufacturing drug supply that could be providing by the end of the summer hundreds and hundreds of thousands of doses of these antibodies. So.

Len Schleifer: There's going to be a lot more that goes into this, and we'll just have to see how this evolves. But the history of the industry typically is that, you know, if there are just a couple of competitors, you know. You have to remember that the size of this market last year was about $22 billion, of which about 70 or 75 percent was lung cancer, and that was largely driven by illicit sales.

You're right, it's never been done before on the other hand, I don't think we ever had quite a pandemic like this before and I think that some companies like ours.

Has really put themselves in a position with the technologies commitments. The investments that we've made to put ourselves in a position to maybe help out and make a difference here and regulators like the F.D.A. bar to everybody's coming together to try to help us in this situation.

Len Schleifer: So there's a pretty big opportunity to have some important alternatives, and you'll just have to wait. I'm sorry, Ron. It's to see how this all evolves and we roll this out.

Operator: Thanks, Ronnie. Next question?

To meet the urgency and meet the dire need that we might have here and so the hope is yeah. It might be possible by the end of the summer or the for that are antibiotic treatment could be available a lot of risks a lot of concerns, but we are working as hard as we can with so many collaborators to try to turn that into reality.

Christopher Joseph Raymond: Your next question comes from the line of Chris Raymond from Piper Sandler.

George D. Yancopoulos: Yeah, thanks. Just, you know, back to the antibody cocktail. I guess. So, you know, George, a lot of folks close to the FDA and maybe some with a fairly loud voice on these COVID matters keep talking about at least one of the therapies, one of the antibody therapies in development being available as early as this fall. So I guess, you know, maybe just talk about how that is possible from a clinical development standpoint, and especially in light of the program you just described, George, with the three different settings. Obviously, when there's something that's even under an emergency use authorization available, how do you conduct that? Thanks.

So we still have several callers sorry, we have several color still in the queue. So we'll we'll extend for a few more.

Minutes, if we can.

Let me just put a fine.

Find a point on that for just a second I completely agree with George said and I figure if you listen carefully to what he was saying is that because we're doing three different types of studies the timing on a different studies might be quite different if you're dealing with people who already have the disease when you're not waiting for that long period to occur when you.

We're trying to prevent the disease and people who already have the disease because of the disease Sorta declares itself you know over a several a week to month period, and so you could imagine depending upon what's going on how many people actually showing up at the hospital. How many people are hospitalized and I see you that that part could go a lot faster.

George D. Yancopoulos: Well, yeah, I think that these are all great questions. We're in unprecedented times. I think that the urgency and the collaborative spirit between regulators, between medical institutions, between companies have never been seen before. And also, our commitment to this is something we've sort of done before, but now we're trying to take it to the next level. So we are planning, as we said, in June, to simultaneously initiate trials in the three settings that we're actually talking about. And we are thinking of ways to synergize between the three classes of trials that we're talking about.

But of course, you can imagine that George and a team.

Allergies for the early part to to try and find people at high enough risk.

Hard part in a preventative setting sorry next question.

Your next question comes from the line of parents Flynn from Goldman Sachs.

I, Thanks, as well for me for all your efforts on the covert front, maybe another one for George on by specifics.

I was just wondering if you've already generated data from your P.S.M.A. by specific antibody as motto therapy and if that's what led to your decision to initiate a combo trial with web Tyo and then the second part of the question relates to your comment George about seen continued continuing promising activity.

George D. Yancopoulos: And we are hoping, I mean, this is going to depend on a lot of factors, and there are obviously a lot of risks and concerns whether this can be done since it hasn't ever been done before. But we are really hoping that we'll be able to not only initiate these studies but, within a month or two, to perhaps, if these agents are working as well as we might hope they would work, as well as, for example, some of the precedents set by Ebola suggested they might work, that we might, within that month or two, be getting data. If we were to get data within those sort of time frames, as Len describes, we would have already committed, at risk, to manufacturing a drug supply that could be providing, by the end of the summer, hundreds and hundreds of thousands of doses of these antibodies.

Wondering if that was only on the P.C.M.A. by specific or if that also covered the mock 16 by specific thank you.

Yeah, great questions.

I guess first of all.

Basically we we think that the by specific costumes.

Describe these in the literature, we have a lot of data on them on their own. They are designed to essentially have very little or no activity.

And only when combined with either a C.D. three by civic or with a P.D. one agent do they then essentially synergizing amplify the benefit or activate the benefit of the other agent and we've done a lot of work on that quite a bit publish work has already been shown on that and the early data.

George D. Yancopoulos: So you're right. It's never been done before. On the other hand, I don't think we've ever had quite a pandemic like this before, and I think that some companies, like ours, have really put themselves in a position with the technologies, the commitments, the investments that we've made to put ourselves in a position to maybe help out and make a difference here. And regulators like the FDA, BARDA, everybody's coming together to try to help us in this situation to meet the urgency and meet the dire need that we might have here. And so the hope is, yeah, it might be possible by the end of the summer or the fall that our antibody treatment could be available. There are a lot of risks, a lot of concerns, but we are working as hard as we can with so many collaborators to try to turn that into a reality. But we still have...

In the clinic.

Are supporting that in that the motto therapy coast in was not intended and did not show single agent activity. We are now in the combination program, where we are hoping to now activate activity by adding the coast him to the P.D. One that's how they were design that's when we're hoping to see.

And that is what we were hoping to be able to generate data that we will be.

Alright, giving.

You.

Information on in the future in terms of the promising activity I think that yeah, we have seen robust activity with the bcm may.

We have not really reported anything on the muck 16.

And say that we are seeing evidence of activity and we'll give you more details on that future.

Times.

You turn specs question.

George D. Yancopoulos: We have several callers still in the queue, so we'll extend it for a few more minutes.

<unk>.

If I may you know we appreciate all the comments from via analysts community faking. It <unk>. We're doing we just want to say we find your notes very useful and very helpful.

Operator: Let me just put a fine on it. I think if you listen carefully to what he was saying is that because we're doing three different types of studies, the timing of the different studies might be quite different. If you're dealing with people who already have the disease, then you're not waiting for that long period to occur when you're trying to prevent the disease. And people who already have the disease, the cause of the disease sort of declares itself, you know, over a several weeks to months period. And so you could imagine, depending upon what's going on, how many people are actually showing up at the hospital, how many people are hospitalized in the ICU, that that part could go a lot faster. But, of course, you can imagine that George and the team have got a lot of great strategies for the early part to try and find people at high enough risk, which is the hard part, in a preventative setting. Next question.

Coverage of this this pandemic.

Useful information that all of you provide on what's going on and what the rates are this and that what can be expected, we really appreciate that as well.

Next question.

Your next question comes with online Josh Shimmer from ever core.

Great. Thanks for taking the question.

Uncovered 19.

Determine the optimal dose for passive immunization, especially if you have to adjust for different levels of exposure. How long do you think a single dose will confer protection and then what a realistic goals in terms of the number of people you can support beyond August prophylactic use considered potential supply constraints. Thank you.

Okay, well basically we have accumulated over many years now a lot of understanding about the doses that one needs to block viral infection, particularly of respiratory and other diseases. So we actually know both an animal models and humans.

Terence C. Flynn: Your next question comes from the line of Terence Flynn from Goldman Sachs.

George D. Yancopoulos: Hi, thanks as well for me for all your efforts on the COVID front. Maybe another one for George on bispecifics. I was just wondering if you've already generated data from your PSMA bispecific antibody as monotherapy and if that's what led to your decision to initiate a combo trial with LibTIO. And then the second part of the question relates to your comment, George, about seeing continuing promising activity. I was wondering if that was only on the BCMA bispecific or if that also covered the MUX16 bispecific. Thank you.

The blood levels to block respiratory infection, and so we are targeting to be significantly above those blood levels were a minimum of at least a month for the prophylactic setting. So there's no guarantees once again these are all predicts.

One's based on experience and other programs with other viruses, but including for example to immerse Corona virus and so we.

I believe we have a good target blood level that we need to meet and achieve and stay above on for at least a month.

George D. Yancopoulos: Yeah, great questions. I guess, first of all, basically, we think that the bi-specific co-stems... We've described these in the literature. We have a lot of data on them. On their own, they are designed to have very little or no activity. And only when combined with either a CD3 bi-specific or a PD-1 agent do they then essentially synergize and amplify the benefit or activate the benefit of the other agent. And we've done a lot of work on that. Quite a bit of published work has already been shown for that, and early data in the clinic are supporting that in that the monotherapy co-STIM was not intended and did not show single-agent activity. We are now in a combination program where we are hoping to now activate activity by adding the co-STIM to the PD-1. That's how they were designed.

Prophylaxis setting and so the profile axes dosing is intended to last for at least among for example in our R.S.V. program.

For one of our programs there we were able to have protection for several months. So minimum of a month is our current target based on maintaining blood levels that we believe you have to maintain above for preventing infection by respiratory viruses.

What was the rest in terms of supply yeah, I'll take that too.

<unk>.

You know going as fast as we can we have an amazing capability and technology that allows us to get high producing cell lines very rapidly we know how to make.

We we are one of the companies that can do this from end to end seamlessly and so I'm.

George D. Yancopoulos: That's what we're hoping to see, and that is what we're hoping to be able to generate data that we will be giving you. In terms of promising activity, I think we have seen robust activity with the BCMA. We have not really reported anything on the MUX-16, but I can say that we are seeing evidence of activity, and we will give you more details on that in future. Thank you, Terence.

Optimistic that we can expand from the initial numbers, we talked about and continue.

To manufacture we have had increased from multiple other companies about perhaps morning to manufacture.

Good dating we suspect maybe the government may want that to happen as well, where we can expand through collaborative efforts and sort of take the unprecedented step, but letting some of our technology outside the company for this purpose as well because that's what probably will need to be done.

Operator: What's the next question?

Len Schleifer: One second, Terence, if I may. You know, we appreciate all the comments from the analyst community thanking us for what we're doing. We just want to say we find your notes very useful and very helpful. The coverage of this pandemic, the useful information that all of you provide on what's going on and what the rates are of this and that and what to be expected, we really appreciate that as well.

Excellent next question.

Your next question comes from the line of yarn worker from.

Good morning, Thanks for a quick question I'm going to shift a little bit George and maybe.

Just so we don't lose track of that that program.

George D. Yancopoulos: Okay, next question.

Operator: Your next question comes from the line of Josh Schimmer from Evercore ISI.

Sounds like that data coming up pretty soon the phase three osteoarthritis data and he thought and any thoughts on Pfizer filed for months to map for approval for this he told the overlook but I want to know what's going on coming down if you can share. Thank you.

Jeff Meacham: Great. Thanks for taking the question.

George D. Yancopoulos: Another one on COVID-19. How do you determine the optimal dose for passive immunization, especially if you have to adjust for different levels of exposure? How long do you think a single dose will confer protection? And then what are realistic goals in terms of the number of people you can support beyond August with prophylactic use considering potential supply constraints? Thank you.

Yeah, our viewpoint with for sending that is that for a long time now as I actually I think most people appreciate is that in many ways. This is a.

Very risky program in that there are there is a.

Now well defined adverse event.

That we are trying to tighter around with the dos and they think that the major question for this program is whether we have been able to find the dos.

George D. Yancopoulos: Okay, well basically, we have accumulated over many years now a lot of understanding about the doses that one needs to block viral infection, particularly respiratory and other diseases, so we actually know both in animal models and in humans the blood levels to block respiratory infection, and so we are targeting to be significantly above those blood levels for a minimum of at least a month in the prophylactic setting. So there's no guarantees, once again, these are all predictions based on experience and in other programs with other viruses, but including, for example, the MERS coronavirus. I believe we have a good target blood level that we need to meet and achieve and stay above for at least a month in the prophylaxis setting.

The needle between this safety concern and between providing sufficient benefit to patients.

If you see other competitors data here, it's been a little difficult for others to to thread. The needle. So this is what we're going to see especially when we see the data that comes out from our ongoing a program that will be getting by the middle of this year, how well we've done to actually find.

You know a magic spot on the dose response curve, where we have sufficient safety, but sufficient benefit and how that might compare to what others have achieved so we are as anxious in excited as you are to see whether we may have to read this needle in a way that really provide.

George D. Yancopoulos: And so the prophylaxis dosing is intended to last for at least a month. For example, in our RSV program, for one of our programs there, we were able to have protection for several months. So a minimum of a month is our current target based on maintaining blood levels that we believe you have to maintain above for preventing infection by respiratory viruses.

<unk> an important alternative for patients as we know the there's a crying literally are crying need here.

For new pain medications, and particularly for the osteoarthritis population and we are hoping that we may have read it that Neil.

Thanks, your own we're going to try to cut the call about quarter to the hour that leaves us with time for a one to two more questions next question Crystal.

George D. Yancopoulos: What was the rest of the question? In terms of supply, yeah, I'll take that to us, thanks.

Question comes from online Carter Cold.

Len Schleifer: We're, you know, going as fast as we can. We have an amazing capability and technology that allows us to get high-producing cell lines very rapidly. We know how to make antibodies. We are one of the companies that can do this from end to end seamlessly. And so I'm optimistic that we can expand from the initial numbers we talked about and continue to manufacture. We have had inquiries from multiple other companies about perhaps wanting to manufacture our cocktail when we have good data, and we suspect maybe the government may want that to happen as well. Where we can expand through collaborative efforts and sort of take the unprecedented step of letting some of our technology outside the company for this purpose as well, because that's probably what will need to be done.

Great. Good morning, Thanks for taking the question.

Retire data sets and thank you for all the covert efforts.

Focusing back on on with Tyo for a second it sounds like most of the commentary sort of.

Permission to the development strategy here and sort of validation of the efforts to date I guess.

But with this data in hand, particularly with lung data sort of either accelerate your focus on brought further broadening out of the novel novel accommodations are potentially a shift.

You know outside agency you shift in sort of that partnership strategy. Thank you.

Right I think that.

This is really a landmark for the field, but also for us.

Computer has stood really unchallenged now.

Particularly in lung cancer, which is driving most of the sales for this entire field because others haven't actually been able to show that they've had truda like agent I think that I understand that concerns about people talking about how are you going to compete but having something that's already.

Len Schleifer: Thanks, Len. Next question.

Operator: Your next question comes from the line of Yaron Worker from Cowan.

Carter Gould: Hey, good morning. Thanks for asking me a quick question.

George D. Yancopoulos: I'm going to shift a little bit, George, and maybe Fesenumab, just so we don't lose track of that program. It sounds like that data is coming up pretty soon, the phase 3 osteoarthritis data. Any thoughts on Pfizer files and Fesenumab for approval? So this is totally overlooked, but I want to know what's coming down the pipeline, if you can share. Thank you.

Going.

Profound clinical activity that we're now seeing as amano therapy with also having also identified this is another thing that people have to appreciate new first in class indications that had been missed by the rest of the field first with detainees squamous cell carcinoma now so I think our establishing reptile as a legitimate mano therapy.

George D. Yancopoulos: Yeah, our viewpoint with Facinimab is that, for a long time now, as obviously I think most people appreciate, is that, in many ways, this is a very risky program in that there is now a well-defined adverse event that we are trying to tighten around the dose. And I think that the major question for this program is whether we have been able to find a dose that threads the needle between this safety concern and providing sufficient benefit to patients. I think if you see other competitors' data here, it's been a little difficult for others to thread the needle. So this is what we're going to see, especially when we see the data that comes out of our ongoing program, which we'll be getting by the middle of this year, how well we've done to actually find a magic spot on the dose-response curve where we have sufficient safety but sufficient benefit and how that might compare to what others have achieved.

Alternative and as lens said when you have.

Opportunities such as 8 billion dollar opportunities in first line history shows that bonafide.

Competitors with profound clinical activity there are going to get significant shares, but I think it's exactly as you said, we believe we are now in a position where we can compete in these mano therapy situation, but it only amplifies are excitement and our commitment to the combination approach.

And of course as you say, we are working hard to find the right outside collaborators and I think we've already announced quite a few of them that we're very excited about that were already starting combination studies on and so forth, but we are just as excited about our internal home grown pipeline.

George D. Yancopoulos: So we are as anxious and excited as you are to see whether we may have threaded this needle in a way that really provides an important alternative for patients. As we know, there is a crying, literally a crying need here for new pain medications and particularly for the osteoarthritis population, and we are hoping that we may have threaded Thanks, Jerome.

We have been preparing.

A series of combination assets just for this moment now where we will have this potent powerful P.D. one antibody of our own our entire strategy depended on it and now that the molecule has come through improved that it really is a bona fide.

Monotherapies competitor out there we are now just doubling motivated and compelled to now build upon that with all these combination opportunities that have been coming out of our labs for the last few years, who we could not be more excited now we will now have the building now only compete as a monetary but now to add.

Operator: We're going to try to cut the call by a quarter of an hour; that leaves us with time for one to two more questions. Next question, Crystal?

Operator: Your next question comes from the line of Carter Gould from Barclays.

With all these combinations all these by civics the coast devices, and so forth as well as these collaboration assets and weaknesses are really exciting time, not only for us but for the field because I I hope you will realize how do you mean oncology field.

Yatin Sanja: Great. Good morning.

Marion McCourt: Thanks for taking the question. Pass on my congratulations on the Libtayo datasets, and thank you for all the COVID efforts. Maybe just focusing back on Libtayo for a second, it sounds like most of the commentary is sort of a reaffirmation of the development strategy here and sort of validation of the efforts to date. I guess, but with this data in hand, particularly the lung data, does this sort of either accelerate your focus on further broadening out of the novel-novel combinations or potentially be a

Despite all the initial excitement has not move phone as much as I think we all would have wanted it to have move forward. We haven't seen the magic combination we haven't seen the dramatic increases.

In in into new cancers, we think we have the opportunity to take that feel to the next level and having the foundational P.D. one anybody of our own really gives us that opportunity. So these are really exciting times for us, but I think for the field that for the first time in a decade, maybe substantial new advances in new age.

Marion McCourt: Right, I think that... This is really a landmark for the field, but also for us. Kachuta has stood really unchallenged now.

George D. Yancopoulos: I'll just say that there are a lot of people who are not necessarily competitive in the field, especially in lung cancer, which is driving most of the sales for this entire field because others haven't actually been able to show that they've had a Keytruda-like agent. I think that I understand the concerns about people talking about how you're gonna compete, but I also have to appreciate new first-in-class indications that have been missed by the rest of the field, first with cutaneous squamous cell carcinoma, and now with basal cell, which I think are establishing Leptio as a legitimate monotherapy alternative. And as Len said, when you have opportunities such as $8 billion opportunities in the first line, history shows that bona fide competitors with profound clinical activity there are gonna get significant shares. But I think it's exactly as you said.

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Yeah.

Quick questions you can be sure we'll get together with collaborative Santa Fe on this and.

Carefully about how to move this forward and how to compete well with the data we have and other data we want to get.

Here next to Crystal time for two more quick ones.

You have your next question comes from the line of Jeff Meachum from Bank of America.

Hey, guys I think so the question and for a squeaking.

One after another one on the code with.

Just to follow up.

Earlier comments about.

Efficacy studies next month I'm, assuming that are going to infer that you're bypassing.

Traditional phase one safety studies unhealthy.

Then when you think about manufacturing scale, what's the opportunity to outsource or to partner.

George D. Yancopoulos: We believe we are now in a position where we can compete in these monotherapy situations, but it only amplifies our excitement and our commitment to the combination approach. And of course, as you say, we are working hard to find the right outside collaborators, and I think we've already announced quite a few of them that we're very excited about, series of combination assets Just for this moment now where we will have this potent powerful PD-1 antibody of our own our entire strategy depended on it And now that the molecule has come through and proved that it really is a bona fide Monotherapy competitor out there. We are now just doubling motivated and Compelled to now build upon that with all these combination opportunities that have been coming out of our labs for the last few years So we could not be more excited that we will now have the ability not only compete as a monotherapy but now to add With all these combinations all these by specifics the coast and by specifics and so forth as well as these Collaboration assets and we think this is a really exciting time not only for us But for the field because I hope you all realize how the immune oncology field, Despite all the initial excitement, it has not moved forward as much as I think we all would have wanted it to have moved forward. We haven't seen the magic combinations. We haven't seen the dramatic increases into new cancers. We think we have the opportunity to take that field to the next level, and having the foundational PD-1 antibody of our own really gives us that opportunity. So these are really exciting times for us, but I think for the field that, for the first

Should you have much higher demand and success obviously on that.

Thank you very much.

Yeah, I think that we have been already inactive conversation with regulators exactly on the points that you you talk that and I think these are unprecedented times and I think also when you have the history with these types of agents does allow you and it does allow the comfort.

Out of the regulators that one could be moving forward very quickly and so as you might imagine along the lines of things that you propose these are exactly the sorts of things that we're talking about with regulators and we're we're trying to employ into our our designs in terms of your second part of your question I think you know lent already started.

Talking.

About this point, which is we have made a huge commitment.

Two.

Enable our entire upstate New York manufacturing facility to be devoted to this effort, which on its own could supply hundreds of thousands if not over the course of time, maybe even on the order of a million or so.

<unk> per month.

However, even that might not be sufficient depending on the demand depending on whether there's a second wave depending on what happens with vaccines and so forth. So we are actively talking about collaboration with others, who are very interested in bringing their resources to the table here too as we said.

There's enormous collaborative spirit that I think you know we haven't seen before.

I mean companies to come together to help each other out to really make a difference here in this pandemic and so that opportunity is really out there were actively talk with people.

Marion McCourt: Quick questions.

Marion McCourt: You can be sure we're getting together with our collaborator Sanofi on this and are going to look carefully at how to move this forward and how to compete well with the data we have and other data we want to

It all depends on whether these antibodies deliver but if they deliver and depending on the state of the pandemic. If there's more need I am sure that there will be ways that either we on our own or with major collaboration will be able to supply.

Marion McCourt: Crystal, time for two more quick ones. Thank you. Your next question comes from the line of Jeff Meacham from Bank of America.

More.

Two more patients.

Operator: Hey guys, thanks for the question and for squeezing me in. I want to ask another question about the COVID cocktail.

Okay, Chris the last question. Unfortunately, we have a lot of people still mchugh, but this will be or last question.

And your question.

Jeff Meacham: Thank you very much.

George D. Yancopoulos: Yeah, I think that we've already been in active conversation with regulators on exactly the points that you talk about, and I think these are unprecedented times, and I think also when you have history with these types of agents, it does allow you, and it does allow the comfort of the regulators that one could be moving forward very quickly, and so, as you might imagine, along the lines of the things that you proposed, these are exactly the sorts of things that we're In terms of the second part of your question, I think Len already started talking about this point, which is that we have made a huge commitment to enable our entire upstate New York manufacturing facility to be devoted to this effort, which could supply hundreds of thousands, if not over the course of time, maybe even on the order of a million or so doses per month.

Yeah.

Okay.

The money and.

I.

I also would like to compliment Bob.

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She had in March.

Guidance.

Today. The question is on the idea fun.

The Cold War anticipating.

It's supply.

By March could you comment where you are incompatible supply as and we're back you saw off the it that's an idea.

One two and also.

If they live in when tree down here and make that too.

Okay.

Okay. So let me let me take theirs I'll start with your last so in terms of inventory of we have stayed at normal levels. So we're not seeing any anything unusual in terms of inventory on your next question and Prefilled syringe. We do think Prefilled syringe is a very attractive alternative in them.

George D. Yancopoulos: However, even that might not be sufficient depending on the demand, depending on whether there's a second wave, depending on what happens with vaccines, and so forth. So we are actively talking about collaborations with others who are very interested in bringing their resources to the table here too. As we said, there is an enormous collaborative spirit that I think we haven't seen before between companies to come together, to help each other out, to really make a difference here in this pandemic, and so that opportunity is really out there. We're actively talking with people, and of course, it all depends on whether these antibodies work, but if they do, and depending on the state of the pandemic, if there's more need, I am sure that there will be ways that either we on our own or with major collaborations will be able to supply more to more patients.

Marketplace and use the Prefilled syringe has gone up to about 75% of total use idea. We have as you know introduce prefilled syringe in a staggered ways starting towards the end of last year, but it's been very well received and we do intend to have not only prefilled syringe.

Which of course is growing in popularity, but will also maintain files in the marketplace and then I believe the other item that you are commenting on was in terms of the cozadd impact and as I shared certainly in the first quarter, we had very robust performance with idea and you know saw our sale.

Operator: Okay, Chris, the last question. Unfortunately, we have a lot of people still in the queue, but this will be our last question.

Yatin Sanja: And your question comes from the line of Yatin Sanja with Guggenheim. Good morning.

Grow on you know in the U.S. marketplace, 9% and that sales over the prior here, we did see as they mentioned a decline in overall demand in the last two weeks of March and that continued into the first two weeks at April then we saw a sharp rebound in the most meaning.

Yatin Sanja: I also appreciate all the effort.

Yatin Sanja: I also would like to compliment Bob for simplifying it.

Yatin Sanja: For more information, visit www.fema.gov.

Marion McCourt: I think, Marion, pre-COVID, you were anticipating full market supply of pre-COVID by March. Could you comment on where you are in terms of the supply of PFS?

Positive.

And in the last two weeks so that when you put all that together and all those factors together demand in a month in April.

Marion McCourt: All of these are on IVF performance in 1Q, and also, I'm not sure if there was any inventory dynamic that you commented on regarding IVF.

Oh wait 15% lower than in the same period last year.

Marion McCourt: Okay, so sure, let me take those. I'll start with your last.

Aligned to say you know, it's hard to predict what will happen with the coded in tackling going forward, but we remain very confident in ideas profile our commitment to the retinal specialists community any you know obviously the very attractive profile, we have both clinically and from a safety standpoint with Ilea, we're supporting.

Marion McCourt: So in terms of inventory, we have stayed at normal levels. So we're not seeing any anything unusual in terms of inventory. Your next question on pre-filled syringes; we do think that the pre-filled syringe is a very attractive alternative in the marketplace, and the use of the pre-filled syringe has gone up to about 75% of total use of ILEA. We have, as you know, introduced pre-filled syringes in a staggered way starting towards the end of last year, but they've been very well received. And we do intend to have not only pre-filled syringes, which are, of course, growing in popularity, but we will also maintain vials in the marketplace. And then I believe the other item that you were commenting on was in terms of the COVID impact.

Our offices, there appropriate promotion and support so that when patients slow tint, you know returns in a more robust fashion, we certainly look forward to the opportunity to help those patients medallia in support our prescribers.

Thank you everyone, that's going to conclude or call. We appreciate everybody hanging on a little longer today, given all the all the things that we had to speak to and all the great questions that came in Bubbling during the I.R. team will be available following the call to answer for the questions. Thank you.

Marion McCourt: And as I shared, certainly in the first quarter, we had very robust performance with ILEA and, you know, saw our sales grow by 9% in the U.S. marketplace over the prior year. However, we did see, as I mentioned, a decline in overall demand in the last two weeks of March, and that continued into the first two weeks of April. Then we saw a sharp rebound in the most recent, meaning a positive trend in the last two weeks, so when you put all that together and all those factors together, demand in the month of April was approximately 15% lower than in the same period last year. But I go on to say, you know, it's hard to predict what will happen with the COVID impact going forward, but we remain very confident in ILEA's profile, our commitment to the We're supporting our offices through appropriate promotion and support so that when patient flow returns in a more robust fashion, we certainly look forward to the opportunity to help those patients with ILEA and support our prescribers.

They say.

Ladies.

Includes today's conference. Thank you for your participation.

And have a wonderful day, you may I'll just okay.

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Operator: Thank you, everyone. That's going to conclude our call. We appreciate everybody hanging on a little longer today given all the things that we had to speak about and all the great questions that came in. Bob Landry and the IR team will be available following the call to answer further questions.

Operator: Stay safe.

Operator: Ladies and gentlemen, this concludes today's conference. Thank you for your participation. And have a wonderful day. You may all just go now.

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BF-WATCH TV: BF-WATCH TV 2021

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