Q1 2021 Regeneron Pharmaceuticals Inc Earnings Call

May 6, 2021

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Operator: Welcome to the Regeneron Pharmaceuticals First Quarter 2021 Earnings Conference Call. My name is Mary, and I will be your operator for today's call. 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 will now turn the call over to Justin Helko, Vice President, Investor Relations. You may begin.

Well.

Good day, Regeneron Pharmaceuticals first quarter 2021 earnings conference call. My name is Murray analogy. Your operator for today's call. 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.

Now I'll turn the call low Richard Justin <unk>, Vice President Investor Relations you may begin.

Justin Helko: Thank you, Mary. Good morning, good afternoon, and good evening to everyone listening around the globe. Thank you for your interest in Regeneron Pharmaceuticals.

Justin Helko: and welcome to the first quarter 2021 conference call. An archive of this webcast will be available.

Justin Helko: Available on our website. Joining me on the call today are Dr. Leonard Schleifer, founder, president, and chief

Justin Helko: Executive Officer, Dr. George Yancopoulos

Justin Helko: Co-Founder, President, and Chief Scientific Officer, Marion McCourt, Executive Vice President and Head of Commercial, and Bob Landry, Executive Vice President and Chief Financial Officer. 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.

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Bailey from those projected in that statement.

Justin Helko: 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 period ended March 31, 2021, which we filed with the

A more complete description of these and other material risks can be found in regeneron filings with the United States Securities and Exchange Commission, including its form 10-Q for the period ended March 31st 2021, which we filed with the SEC earlier today Regeneron does not undertake any obligation to update any forward looking statement.

Justin Helko: Regeneron does not undertake any obligation to update any forward-looking statements.

Whether as a result of new information future events or otherwise. In addition, please note that the gap and non-GAAP measures will be discussed in today's call.

Justin Helko: In addition, please note that the gap and non-gap 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. Once our call concludes, Bob Landry and the IR team will be available to answer further questions.

Information regarding our use of non-GAAP financial measures in a reconciliation of those measures to GAAP is available and our financial results press release, which can be accessed on our website. Once our call concludes Bob Landry and the I R team will be available to answer for the questions with that let me turn the call over to our President and Chief Executive Officer.

Justin Helko: I turn the call over to our President and Chief Executive Officer, Dr. Len Schleifer.

Doctor Lynch Lifer.

Leonard S. Schleifer: Thank you, Justin, and thank you to everyone joining today's call. We're off to a strong start in 2021, again delivering double-digit growth on the top and bottom lines. I'm immensely proud of all that Regeneron continues to accomplish in the fight against COVID and for patients suffering from a variety of diseases. Our performance highlights the continued evolution, diversification, and durability of our business as we enter a new phase of growth and new product launches.

Thank you Justin and thank you to everyone joining today's call.

We're we're off to a strong start 2021 again delivering double digit growth on the top and bottom line I'm immensely proud of all that we generally continues to accomplish in the fight against COVID-19 and for patient suffering from a variety of diseases.

Our performance highlights the continued evolution diversification and durability of our business as we enter a new phase of growth and new product launches.

Leonard S. Schleifer: Strong performance begins with differentiated products that deliver real value for patients. Starting with ILEA, global net sales were nearly $2.2 billion, growing 17% compared to the prior year. In the U.S., sales grew 15%, reflecting continued positive momentum and execution on our strategy. We are confident in the ILEA business and expect it to remain a key growth driver for Regeneron for years to come. We are also very pleased with the performance of Dupixent in the quarter, where global sales approached $1.3 billion and grew 48%.

Strong performance begins with differentiated products that to live a real value for patients.

Starting with I Leah Global net sales were nearly 2.2 billion growing 17% compared to the prior year in the U S. Sales grew 15 per cent, reflecting continued positive momentum and execution on a strategy.

We are confident in the Eylea business and expect it will remain a growth driver for regeneron for years to come.

We're also very pleased with the performance of do pick sent in the quarter with global sales approached 1.3 billion and grew 48%.

Leonard S. Schleifer: The brand is now annualizing sales in excess of $5 billion, yet we believe there remains considerable room for further market growth and penetration in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis. With several additional potential indications in phase 3 trials, such as eosinophilic esophagitis, and COPD, we are still in the early days of realizing the full potential of this unique pipeline in In oncology, we are making steady progress with LibGyo, as global net sales reached 101 million and grew 35% from the prior year.

The brand is now annualizing sales in excess of 5 billion.

Leonard S. Schleifer: Importantly, in February, we secured two new FDA approvals for libtiol in basal cell carcinoma and in non-small cell lung cancer, which we anticipate will help fuel a new period of growth for this product and is a foundation for our oncology strategy.

Leonard S. Schleifer: While still in the very early days with these new launches, we are seeing encouraging signals on a variety of leading indicators from thought leaders, prescribers, payers, and patients. And, last but not least, we were able to deliver significant phase 3 outcome data for our RegenCOVE program aimed at treating and preventing COVID-19 infections. As George will outline momentarily, we have now shown that our antibody cocktail dramatically reduces hospitalizations or death in non-hospitalized COVID-infected patients and reduces symptomatic infections when given as a preventative measure.

Leonard S. Schleifer: We are seeking to update our emergency use authorization to reflect these new data and uses, as well as the lower 1.2 gram dose. Thinking longer term for Regencov, we see an ongoing global need for treatment and chronic prevention of COVID disease. Despite high rates of vaccination, it's estimated that tens of millions will remain unvaccinated in the U.S. alone. And of those who are vaccinated, significant numbers will not mount a protective response, such as those who are immunocompromised or immunosuppressed.

To reflect these new data and uses as well as the lower 1.2 Gram dose.

Thinking longer term for Regeneron <unk>, we see an ongoing global need for treatment and chronic prevention of COVID-19 disease. Despite high rates of vaccination. It's estimated that tens of millions will remain unvaccinated in the U S alone and of those who are vaccinated.

Significant numbers will not Mount a protective response, such as those who are immuno compromised or immuno suppressed.

Leonard S. Schleifer: It is important to recognize Regeneron's and the biopharmaceutical industry at large's response and ongoing actions in combating COVID-19. Breakthrough vaccines and treatments are having a profound impact on the health and well-being of people in the United States and around the globe. In addition, safe and effective vaccines and treatments are enabling economic recovery. All of these critical benefits come as a result of the investments that have been made in technology over decades by both the public and private sectors.

It is important to recognize regeneron in the biopharmaceutical industry at large response and ongoing actions and companion COVID-19.

Breakthrough vaccines and treatments are having a profound impact on the health and well being of people in the United States and around the globe.

In addition, safe and effective vaccines and treatments are enabling economic recovery.

All of these critical benefits come as a result of the investments that have been made in technologies over decades by both the public and private sectors. These.

Leonard S. Schleifer: These profound effects highlight the importance of a healthy biopharmaceutical industry that fully incentivizes innovation so that new solutions to emerging diseases can rapidly be invented and tested. But we've also learned that these extraordinary approaches to preventing and treating COVID-19 can work only if people actually receive the vaccines or drugs. For example, an internal health economic analysis projected that tens of thousands of lives in the United States could be saved over the next several months if Regencove were fully deployed and given to all appropriate patients who are diagnosed with COVID-19 and at high risk for hospitalization or death.

Leonard S. Schleifer: And this is a case where cost to patients is not an issue as the government is providing the drug free of charge. Clearly, we have to better understand why a drug that has demonstrated overwhelming evidence for its ability to reduce hospitalizations or death by 70% is in an ample supply, has been endorsed by the NIH, has been authorized under an EUA by the FDA, and is free of charge to patients is not being taken full advantage of. Regeneron is committed to collaborating with our health care partners. Take Optimal Advantage of the Regeneron Pharmaceuticals Inc.

Leonard S. Schleifer: Take optimal advantage of the Regencov cocktail's potential health benefits. Israel

Leonard S. Schleifer: Overall, we are pleased with all that Regeneron has accomplished. Thank you all for joining us for the first three months of the year and look forward to continued momentum and progress. And, of course, our diverse pipeline for the month. Now I will turn the call over to George.

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Now I will turn the call over to George.

George D. Yancopoulos: Thank you, Len. With COVID-19 still in the headlines, I will start with our monoclonal antibody treatment. Regen-COV cocktail. We recently reported data from a large phase 3 outcomes trial in the outpatient setting confirming that Regen-COV reduced the risk of hospitalization or death by 70% with both the 2.4 gram and the lower 1.2 gram doses, We are pleased that, based on these data, the NIH guidelines were updated in early April to include a strong recommendation for monoclonal antibody combinations to treat outpatients with mild or moderate COVID-19, as defined by the EUA criteria.

Thank you line.

With COVID-19 still in the headlines I will start with our monoclonal antibody treatment.

The code reject co cocktail, we recently reported data from a large phase III outcomes trial in the outpatient setting confirming that region code reduce the risk of hospitalization or death by 70% with both the two four Graham in the lower one two gram doses. We are pleased that based on these data Dnaase guidelines were updated in early.

April to include a strong recommendation for monoclonal antibody combinations to treat outpatients with mild or moderate COVID-19 as defined by the EUA criteria.

George D. Yancopoulos: We also have recently reported data from a large, two-part, Phase III trial of RegenCODE with Part A in the preventative setting and Part B in recently infected patients. In Part A of the trial, RegenCo prevented 81% of symptomatic COVID-19 infections, with 93% prevention after the first week. A supportive study in healthy volunteers that explored chronic dosing showed a similar 92% prevention of infection. Notably, these results were achieved with a convenient subcutaneous formulation.

We also have recently reported data from a large two part phase III trial of region cope with par day in the preventative setting and part B and recently infected patients and part of the trial region cold prevented 81% of symptomatic COVID-19 infections with 93% prevention after the first week.

Ah support a study in healthy volunteers that export chronic dosing showed a similar 92% prevention of infection.

Notably these results were achieved with the convenience subcutaneous formulation chronic prevention with our antibiotic cocktail may prove to be critical in the ongoing battle against this virus. Despite high rates of vaccination. It is estimated that tens of millions of Americans will remain unvaccinated, that's at risk for future infection. In addition is estimate that knee.

George D. Yancopoulos: Chronic prevention with our antibody cocktail may prove to be critical in the ongoing battle against this virus. Despite high rates of vaccination, it is estimated that tens of millions of Americans will remain unvaccinated and thus at risk of future infection. In addition, it is estimated that millions of Americans will not mount an adequate response to vaccines.

<unk> of Americans will not Mount an adequate response to vaccines for example, immuno compromised individuals are Oregon transplant patients.

George D. Yancopoulos: For example, immunocompromised individuals or organ transplant patients, or who suffer from certain cancers such as lymphomas, leukemias, and myelomas, or immunosuppressant therapy for their autoimmune diseases might all be candidates for chronic prevention using our antibody cocktail. Part B of this phase 3 trial in recently infected patients also showed that the subcutaneous administration of the 1.2 gram dose was also effective in reducing symptomatic disease and We are anticipating the existing EUA will be amended based upon the above data to include the 1.2 gram RegenCODE dose to allow the cocktail to be used for prevention, and to include the subcutaneous formulation for ease of use.

Or who suffer from certain Kansas, such as lymphomas, leukemias, and myeloma, where an immunosuppressant therapies for their autoimmune diseases might all be candidates for chronic prevention using our antibody cocktail.

Poppy of this phase III trial, and recently infected patients showed that the subcutaneous administration of the one two gram dose was also effective in reducing symptomatic disease and shortening disease duration.

We are anticipating the existing EUA will be mended based upon the above data to include the one two gram regent coke dose to allow the cocktail to be used for prevention and to include the subcutaneous formulation for ease of use we believe the current data is supportive of a potential formal VLA approval by.

George D. Yancopoulos: We believe the current data is supportive of a potential formal BLA approval by the FDA. I would like to remind everyone that outside of the United States, some countries have an even more ongoing dire need for COVID-19 medicine.

The FDA.

I would like to remind everyone that assets to the United States, where some countries have an even more ongoing dire need for COVID-19 medicines are partner Roche is rapidly expanding availability of the treatment.

George D. Yancopoulos: Last year, we anticipated that certain variants were likely to emerge and therefore designed our current cocktail to be active against these variants. Experimental evidence suggests FedOpCocktail is indeed active against all current variants of concern. Similarly, in anticipation of future variants that may emerge, we are bringing additional antibodies to the clinic shortly. Moving on to ILEA.

George D. Yancopoulos: A recent NIH-sponsored Protocol W trial in non-proliferative diabetic retinopathy patients confirmed the results of our own panorama study. After two years, ILEA reduced vision-threatening complications by 68% compared to a group of patients who delayed treatment. A recent Regeneron follow-up analysis in a similar design panorama trial found that delaying treatment resulted in three times as many patients suffering prolonged vision loss compared to those receiving preventative ILEA treatment during a two-year period. Similar analysis has not yet been conducted for Protocol W. Protocol W is the second study in diabetic retinopathy showing benefits of a less frequent ILEA dosing regimen, and we are planning on filing to expand the U.S. ILEA label by adding the 16-week dosing interval for appropriate patients in the second half of this year.

George D. Yancopoulos: By year-end, we are expecting the first data from the Phase 2 study testing a high dose of ILEA in wet AMD. From these data, we can expect early reads on anatomic differences and drying between the higher and lower doses at 8 and potentially 12 week intervals. While the study data will not be definitive on durability measures, the Phase 2 study will help provide insights on what we might expect from the Phase 3 studies, which are testing dosing intervals out to 12 and 16 weeks.

<unk> are expected to be fully enrolled by the second half of this year.

Moving onto depicts our immunology and inflammation portfolio.

Dozens of recent presentations at key dermatology meetings highlight the ever increasing scope of depicts an efficacy and safety in patients as young as six years old, including rapid itch relief sustained improvement in disease severity and overall quality of life.

George D. Yancopoulos: Importantly, in the 106 patients dosed in the Open Label Phase 2 study so far, we haven't seen any concerning safety signals. Phase III studies in wet AMD and in DME are expected to be fully enrolled by the second half of this year. Moving on to Dupixent in our Immunology and Inflammation Portfolio, dozens of recent presentations at key dermatology meetings highlight the ever-increasing scope of Dupixent efficacy and safety in patients as young as six years old, including rapid itch relief, sustained improvement in disease severity, and overall quality of life. And importantly, dupixent is not an immunosuppressant, meaning we have not seen an increased risk of serious infections with dupixent.

Importantly to pixel is not immunosuppressive near where we have not seen an increased risk of serious infections with depicts it.

This mounting wall of data and physician experience Fortifies, our fortifies, our belief that depicts and will remain the preferred choice for multiple type two inflammatory diseases.

In the first quarter, we submitted data to support the use of depicts and in children six to 11 years old with moderate to severe asthma. The BLA supplement has an FDA action date of October 21 of this year a similar application has been submitted in the EU.

We prudently announced positive data in the <unk>.

Part a part of our phase III trial in eosinophilic Esophagitis and part B of this trial is fully enrolled in addition, two phase III trials of depiction in type two COPD are actively enrolling patients are complementary program.

George D. Yancopoulos: This mounting wall of data and physician experience fortifies our belief that Dupixen will remain the preferred choice for multiple type 2 inflammatory diseases. In the first quarter, we submitted data to support the use of Dupixen in children 6 to 11 years old with moderate to severe asthma. The BLA supplement has an FDA action date of October 21st of this year. A similar application has been submitted in the EU.

With our anti IL 33 antibody it a pick a mab in a different group of COPD patients former smokers is progressing with both phase III trials now enrolling.

We believe that this broad COPD program, including to Pyxis and <unk> may provide real benefit for many patients.

Turning now to our novel approach to treat allergy by using cocktails of monoclonal antibodies to directly bind and inactivate. The Allergan. These cocktails are designed to act immediately and to be long lasting and to replace currently cumbersome approaches to allergy desensitization that involve years of multiple weekly injections the.

George D. Yancopoulos: We previously announced positive data in the Part A part of our Phase III trial of E. encephalic esophagitis, and Part B of this trial is fully enrolled. In addition, two Phase III trials of Dupixen and Type II COPD are actively enrolling patients. A complementary program.

The anti <unk> antibody cocktail bonds and inactivate the Betsy one allergen that causes birch pollen allergy one of the most common seasonal allergies that occur in the spring.

George D. Yancopoulos: With our anti-IL-33 antibody, itopicumab, in a different group of COPD patients, former spokers, is progressing, with both phase 3 trials now enrolling. We believe that this broad COPD program, including Dupixen and Idipicumab, may provide real benefit for many patients. Turning now to our novel approach to treat allergy by using cocktails of monoclonal antibodies to directly bind and inactivate the allergen. These cocktails are designed to act immediately and to be long-lasting and to replace currently cumbersome approaches to allergy desensitization that involve years of multiple weekly injections.

Following phase two data showing immediate and long lasting effects against allergen challenge, we initiated a phase III study and results are expected later this year.

Assuming success in the current study we're planning to conduct a second phase II study during an upcoming birch pollen season.

Regarding our similar.

Similarly, designed <unk>, one antibody cocktail for cat allergy phase.

<unk> phase II data were presented earlier this year at a quad AI meeting showing that single administration of the antibody cocktail prevented early asthma reactions and allergic patients and prevented lung function decline upon cat allergen exposure when compared to placebo.

Following this positive data update our first phase II trial in Cat allergy is planned for later this year.

We are enthusiastic about these novel additions to our inflammation and immunology portfolio that could represent new groundbreaking ways to treat allergic diseases.

George D. Yancopoulos: The anti-BETF-1 antibody cocktail binds and inactivates the BETF-1 allergen that causes birch pollen allergy, one of the most common seasonal allergies that occur in the spring. Following Phase 2 data showing immediate and long-lasting effects against allergen challenge, we initiated a Phase 3 study, and results are expected later this year. Assuming success in the current study, we are planning to conduct a second phase 2 study during an upcoming birch pollen season.

Moving on to lip tile and our oncology portfolio in the first quarter low tier was approved for the first line treatment of certain patients with non small cell lung cancer and for advanced basal cell carcinoma, each being crucial early milestones for our oncology strategy. In addition, a phase III study of Lyft Tayo.

Second line cervical cancer was stopped early for an overwhelmingly positive overall survival benefit.

First for any systemic treatment in these patients. These data will be shared at an upcoming medical meeting and regulatory submissions are planned for this year.

Additionally, we look forward to sharing expanded dataset of <unk>, our anti lag three program at the upcoming Astro meeting van <unk> is being studied in combination with <unk> in first line melanoma.

George D. Yancopoulos: Regarding our similar, similarly designed Fel-D-1 antibody cocktail for Cat-Al, phase II data were presented earlier this year at a Quad AI meeting showing that single administration of the antibody cocktail prevented early asthma reactions in allergic patients and prevented lung function decline upon cat allergen exposure when compared to placebo. Following this positive data update, a first phase 3 trial in cat allergy is planned for later this year.

In the second half of this year, we anticipate results of an interim analysis for overall survival in our phase III trial lung cancer chemotherapy combination study.

Moving on to our bi specific portfolio in multiple myeloma, our BC made by <unk> by specific for which we now hold exclusive development rights is continuing through dose escalation and dose expansion, we expect to initiate new combination studies in earlier lines of multiple myeloma later this year.

George D. Yancopoulos: We're enthusiastic about these novel additions to our inflammation immunology portfolio that could represent new, groundbreaking ways to treat allergic diseases. Moving on to Leptile and our Oncology Portfolio In the first quarter, Leptile was approved for the first line treatment of certain patients with non-small cell lung cancer and for advanced basal cell carcinoma, each being crucial early milestones for our oncology strategy. In addition, a phase 3 study of Leptio in second-line cervical cancer was stopped early for an overwhelmingly positive overall survival benefit, a first for any systemic treatment in these patients.

Regeneron is uniquely positioned to mix and match multiple modalities and targets with the hope of increasing deep responses. We are already observing with the CD three by specific we're planning to add a co stim bispecific.

Our arsenal of clinical stage multiple myeloma investigational therapies.

Early next year.

Moving to lymphoma responses to our CD 20 by five three by specific <unk> ex demand demonstrate increasing durability regarding the partial clinical hold on this program. We have agreed to a path forward with the FDA submitted the updated protocol and are expected to hear back on lifting the partial hold in the very near term enrollment of.

Follicular lymphoma, and diffuse large b cell lymphoma cohorts of the phase II pivotal intent trial should resume quickly thereafter. Additionally testing of the <unk> ex to May of subcutaneous formulation will start later this year and the paired co stim Bispecific combination is also on track to initiate within the next 12 months.

George D. Yancopoulos: These data will be shared at an upcoming medical meeting, and regulatory submissions are planned for this year. Additionally, we look forward to sharing an expanded data set of Pheanlamab, our anti-LAG-3 program, at the upcoming ASCO meeting. Pheanlamab is being studied in combination with Leptile in first-line melanoma. In the second half of this year, we anticipate results of an interim analysis for overall survival in our Phase III Leptile Lung Cancer Chemotherapy Combination Study. Moving on, to our BISPECIFIC portfolio.

Regarding our solid tumor efforts with our bispecific ovarian cancers. The first indication for which we are already clinically testing two different types of bi specifics for the appropriate tumor target Mark 16 dose escalation of our MX 16 by CD three Bispecific is ongoing we're hoping to share initial data next year.

If not sooner in the <unk> by CD 28, co Stim study patients are dosed in combination with lip tile and dose escalation is ongoing.

Combination of the CD, three and CD 28, co stim Bispecific targeting <unk> will start later this year and it has the potential to be a game changing strategy for treatment of these solid tumors.

George D. Yancopoulos: In multiple myeloma, our BCMA by CD3 BISPECIFIC, for which we now hold exclusive development rights, is continuing through dose escalation and dose expansion. We expect to initiate new combination studies in earlier lines of multiple myeloma later this year. Regeneron is uniquely positioned to mix and match multiple modalities and targets with the hope of increasing the deep responses we are already observing with the CD3 bispecific. We are planning to add a co-stim bispecific to our arsenal of clinical stage multiple myeloma investigational therapies early next year.

In prostate cancer.

The SMA by CD 28 is in dose escalation studies with lip tile and we hope to share initial data next year as soon as seen in our other programs. We are planning on introducing a potentially complementary CD three by specific to the clinic later this year rounding out a powerful and unique toolkit for prostate cancer currently considered under.

Responsive to immunotherapy.

Regarding our early efforts in lung cancer and other solid tumors are egfr by <unk> co stim Bispecific is in dose escalation phase in patients are now dosing combination are now being dose in combination with lip time are met by net bi specific antibody is in the dose expansion state.

Recall that this study is enrolling non small cell lung cancer patients with a broad selection.

George D. Yancopoulos: Moving to lymphoma, responses to our CD20 by CD3 bispecific ogenectomab demonstrate increasing durability. Regarding the partial clinical hold on this program, we have agreed to a PATH vote with the FDA, submitted the updated protocol, and are expected to hear back on lifting the partial hold in the very near term. Enrollment of the follicular lymphoma and diffuse large B-cell lymphoma cohorts of the Phase 2 Pivotal Intent Trial should resume quickly thereafter.

Ah patients, including met exon 14 gene mutations gene amplification, and our elevated net protein expression.

We believe our oncology portfolio as one of the most exciting in the field and has the potential to revolutionize the treatment of diverse difficult to treat cancers.

Finally, I would like to highlight our capabilities regarding the Regeneron genetic center and our genetics medicines efforts. In addition to being able to discover and validate targets that we can address with our velocity <unk> antibody platform, we're working with our collaborators to develop three additional platforms that have the potential to generate new classes.

A generics based medicines first gene editing we are eagerly awaiting initial results from the first systemic based CRISPR approach to be announced mid year by our collaborator intaglio. If positive. These results will validate this gene editing platform for a host of genetic targets identified by the Regeneron chips.

George D. Yancopoulos: Additionally, testing of the Otronextumab subcutaneous formulation will start later this year, and the paired CoSTIM bispecific combination is also on track to initiate within the next 12 months. Regarding our solid tumor efforts with our bispecific, ovarian cancer is the first indication for which we are already clinically testing two different types of bispecifics for the appropriate tumor target, MUX16. Dose escalation of our MUX16 by CD3 bispecific is ongoing, and we are hoping to share initial data next year, if not sooner.

Genetic center and being investigated under our collaboration with <unk>.

Second we are also excited about our mylan collaboration with its validated SA RNA platform approach that consumer really address complementary genetics targets.

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Target.

HST directed to <unk> 171, three a target discovered by the Regeneron genetic center is now enrolling Nash patients. Additionally, we in El myeloma collaborate in a series of follow on targets.

George D. Yancopoulos: In the MUX16 by CD28 CoStim study, patients are dosed in combination with Leptio, and dose escalation is ongoing. Combination of the CD3 and CD28 CoA and bispecifics targeting MUC16 will start later this year, and it has the potential to be a game-changing strategy for treatment of these solid tumors and Prostate Cancer. PSMA by CD28 is in dose escalation studies with liptyle, and we hope to share initial data next year or sooner.

While the technology is currently validated for liver directed therapeutic approaches we are set to extend to <unk> and central nervous system targets.

Our third genetic medicine approach involves viral gene therapy delivery.

And as another approach is significant.

Interest and excitement at Regeneron, our first gene therapy program is in collaboration with decibel focusing on targeting the ear, we ingestible or planning to enter the clinic with DB cash <unk> next year. In addition to the AAV is targeting the year, we are developing a platform for use in multiple other tissues of interest.

George D. Yancopoulos: As seen in our other programs, we are planning on introducing a potentially complementary CD3 biospecific to the clinic later this year, rounding out a powerful and unique toolkit for prostate cancer currently considered unresponsive to immunotherapy. Regarding our early efforts in lung cancer and other solid tumors, our EGFR by CD2A co-stem bispecific is in the dose escalation phase, and patients are now being dosed in combination with Liptile. Our MET by MET bispecific antibody is in the dose expansion stage. Recall that this study is enrolling non-small cell lung cancer patients with a broad selection, including patients with MET, Exxon-14, gene mutations, gene amplification, and or elevated MET protein expression.

With that I would like to turn the call over to Murray.

Thank you George Ralph can exciting start in 2021, our expanded commercial portfolio increased three recent product and indication launches and we continue to grow our largest brands in India. It takes an inlet tile based on competitive and differentiated profiles.

Beginning with Eylea first quarter global net sales grew 17% year over year to nearly $2 2 billion in the U S. Eylea net sales grew 15% year over year to 135 billion based on increased demand and a favorable comparison to the early weeks of the pandemic in the first quarter of 2020.

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And Liam is capturing category growth and continues to be the preferred treatment option.

In your branches into that category and Leah has approximately 75% share and is approaching 50% of the combined branded and unbranded category at Lee is differentiated by the combination of its efficacy safety and dosing flexibility and range of indications. In addition physicians have considerable.

George D. Yancopoulos: We believe our oncology portfolio is one of the most exciting in the field and has the potential to revolutionize the treatment of diverse, difficult-to-treat cancers. Finally, I would like to highlight our capabilities in the Regeneron Genetic Center and our genetics medicines efforts. In addition to being able to discover and validate targets that we can address with our Velocimin antibody platform, we're working with our collaborators to develop three additional platforms that have the potential to generate new classes of genetics-based medicine. First, gene editing.

Real world experience with more than 40 million injections administered worldwide.

The broader category demand continues to improve in 2021 as patient flow normalizes and new patient volume growth. We are confident in our near and longer term outlet based on favorable patient demographics.

<unk> preference for Eylea growth opportunities in diabetic eye disease, and future opportunities with our high dose clinical program.

George D. Yancopoulos: We're eagerly awaiting initial results from the first systemic-based CRISPR approach to be announced mid-year by our collaborator, Intelia. If positive, these results will validate this gene editing platform for a host of genetic targets identified by the Regeneron Genetic Center and being investigated under our collaboration with Intelia. Second, we are also excited about our aniline collaboration with its validated siRNA platform approach that can similarly address complementary genetic targets. Oral

Turning to mid tier first quarter global net sales grew to $101 million with U S. Net sales of $69 million. The vast majority of first quarter sales were in cutaneous squamous cell carcinoma, where lead times is the number one systemic treatment.

We're excited by recent approvals in non small cell lung cancer, and basal cell carcinoma, or BCC, both of which represent meaningful growth opportunities for low tayo in April we deployed our expanded and highly experienced field force across these indications to extend on the tire promotional impact in low.

George D. Yancopoulos: Target ALN HSD directed to HSD17B13. A target discovered by the Regeneron Genetic Center is now enrolling NASH patients. Additionally, we and Al Nilem are collaborating on a series of follow-on targets. While the technology is currently validated for liver-directed therapeutic approaches, we are set to extend it to eye and central nervous system targets. Our third genetic medicines approach involves viral gene therapy delivery, and is another approach of significant interest and excitement

In cancer, we have heard from oncologists that low tier is highly competitive based on the strength of our compelling clinical data and overall value proposition.

Early launch indicators are encouraging with uptake evidenced at top academic and community based practices.

Advancing formulary placement securing favorable payer coverage decisions and growing overall market awareness importantly, low tier was rapidly included in the MCC and guidelines with a category one preferred rating.

George D. Yancopoulos: Our first gene therapy program is in collaboration with Decibel, focusing on targeting the ear. We in Decibel are planning to enter the clinic with DB-OTO next year. In addition to the AAVs targeting the ear, we are developing a platform for use in multiple other tissues of interest.

And CCM guidelines have also been updated to include low Tayo and BCC as the category QA option with Tyler is the only anti PD one approved in advance disease for this indication early feedback has been encouraging as physicians are eager to prescribe volatile based on its efficacy and tolerability.

Matt: With that said, I would like to turn the call over to Matt.

Matt: Thank you, George. We're off to an exciting start in 2021. Our expanded commercial portfolio includes three recent product and indication launches, and we continue to grow our largest brands, Alia, Dupixent, and Liptio, based on competitive and differentiated profiles. Beginning with ILEA, first quarter global net sales grew 17% year over year to nearly $2.2 billion. In the US, ILEA net sales grew 15% year over year to $1.35 billion based on increased demand and a favorable comparison to the early weeks of the pandemic in the first quarter of 2020.

Hedgehog inhibitors, despite being used as first line treatment may not be suitable for patients for long term or repeat use with tayo is an important new care alternative for BCC patients in summary, along in BCC launches are progressing according to plan and we are highly focused on ensuring the appropriate patients.

Benefit from Tayo.

Turning now to a teaser which was also approved in the first quarter of 2021 and is in the initial launch phase of <unk> represents a novel and effective treatment for patients with homozygous familial hypercholesterolemia and is recognized by trading specialists as an improvement over the current standard of care patient demand is steadily.

Matt: Aliyah is capturing category growth and continues to be the preferred treatment option. In the branded anti-VEGF category, ILEA has approximately 75% share and is approaching 50% of the combined branded and unbranded category. ILEA is differentiated by the combination of its efficacy, safety, dosing flexibility, and range of indications.

Building with multiple patients already initiated on therapy.

Moving to the global net sales in the first quarter were one point.

Two 6 billion, representing 48% growth compared to the prior year.

Broad based growth across all approved indications generated net sales of $962 million with the new patient starts now higher than pre COVID-19 levels in atopic dermatitis depictions largest indication prescribing continues to be strong across both moderate and severe disease and across age groups. Following our adolescent.

Matt: In addition, physicians have considerable real-world experience with more than 40 million injections administered worldwide. Across the broader category, demand for the products will continue to improve in 2021 as patient flow normalizes and new patient volume grows. We are confident in our near and longer-term outlook based on favorable patient demographics, physician preference for ILEA, growth opportunities in diabetic eye disease, and future opportunities with our high-dose clinical program. Turning to LibTio, first quarter global net sales grew to $101 million, with U.S. net sales of $69 million.

Pediatric lunches.

A significant opportunity for continued growth based on remaining unmet need among eligible patients <unk> is the number one dermatologist prescribed biologic based on the depth and breadth of its long term efficacy and safety profile.

Turning to asthma.

We are actively preparing to launch in pediatric patients as young as six years of age later this year.

Matt: The vast majority of first-quarter sales were in cutaneous squamous cell carcinoma, where LibTio is the number one systemic treatment. We're excited by recent approvals in non-small cell lung cancer and basal cell carcinoma, both of which represent meaningful growth opportunities for Leptio. In April, we deployed our expanded and highly experienced field force across these indications to extend our Leptio promotional impact.

Among adolescents and adults we continued to meaningfully expand the number of depicts and patient initiations driven by our extensive provider and patient educational efforts.

In addition demand is strong among e&ps and allergists for patients with nasal polyps.

<unk> is the SaaS just growing biologic in respiratory disease in our approved indications with substantial room for growth.

I'd also like to highlight efforts supporting our antibody cocktail for Gen curve in the first quarter, we recorded U S. Net sales of 262 million under the first contract with U S government.

Matt: In lung cancer, we have heard from oncologists that Liptio is highly competitive based on the strength of our compelling clinical data and overall value proposition. Early launch indicators are encouraging, with uptake evidence at top academic and community-based practices. We're advancing formulary placement, securing favorable payer coverage decisions, and growing overall market awareness. Importantly, Liptio was rapidly included in the NCCN guidelines with a Category 1 preferred rating. The NCCN guidelines have also been updated to include Liptio in BCC as a Category 2A option.

Jen COVID-19 currently authorized under an EUA in patients based on age and risk factors, which represent close to 40% of all adults diagnosed with COVID-19, we're focused on reducing bottlenecks and increasing utilization, particularly in states with high infection rates.

<unk> include direct support to key facilities medical education that <unk> partnering with third party stakeholders and educating consumers on the availability of antibody treatments as.

As George mentioned, we are preparing for a potential update of the re gen curve EUA to include prevention as we hope to be able to address an unmet need for millions of patients who may be candidates for ongoing preventative treatment preventative therapy may also be important for those who have known COVID-19 exposure.

Matt: Liptio is the only anti-PD1 approved in advanced disease for this indication. Early feedback has been encouraging as physicians are eager to prescribe Liptio based on its efficacy and tolerability. Hedgehog inhibitors, despite being used as first-line treatment, may not be suitable for patients for long-term or repeat use. Liptio is an important new care alternative for BCC patients.

And require very rapid protection.

In summary, we delivered robust performance across our portfolio in the first quarter of the year.

Matt: In summary, our Lung and BCC launches are progressing according to plan, and we are highly focused on ensuring that appropriate patients benefit from LibTiO. Turning now to APHTESA, which was also approved in the first quarter of 2021 and is in the initial launch phase. APHTESA represents a novel and effective treatment for patients with homozygous familial hypercholesterolemia and is recognized by treating specialists as an improvement over the current standard of care.

<unk> has strong positive momentum from our in line business encouraging early signals from our recent launches and substantial opportunity for continued diversified growth now I will turn the call over to Bob.

Thanks, Marion and good morning, and afternoon to everyone listening to the call. My comments today are on on financial results and outlook will be on a non-GAAP basis, where applicable as <unk> stated regeneron is off to a strong start in 2021, as we continue to execute across the business delivering double digit top and bottom line.

Matt: Patient demand is steadily building, with multiple patients already initiated on therapy. Moving to DEPIXEN, global net sales in the first quarter were $1.26 billion, representing 48% growth compared to the prior year. In the U.S., broad-based growth across all approved indications generated net sales of $962 million, with new patient starts now higher than pre-COVID levels. In atopic dermatitis, DEPIXEN's largest indication, prescribing continues to be strong across both moderate and severe disease and across age groups following our adolescent and pediatric launches. There is significant opportunity for continued growth based on remaining unmet need among eligible patients. DEPIXEN is the number one dermatologist-prescribed biologic based on the depth and breadth of its long-term efficacy and safety profile.

Growth in the first quarter.

For the first quarter total revenues grew 38% year over year to $2 5 billion driven by growth in global Eylea sales increased scientific collaboration profitability driven by depiction and sales of our Virgin Cove antibody cocktail.

Diluted net income per share grew 50% year over year to $9 89.

Net income of $1 1 billion, excluding revenues related to reject coal regeneron achieved 20% <unk>.

Total revenue growth versus the prior year as you heard from Marion We completed our initial contract to supply <unk> to the U S government in the first quarter.

Matt: Turning to asthma, where we are actively preparing to launch in pediatric patients as young as six years of age later this year. Among adolescents and adults, we continue to meaningfully expand the number of patients driven by our extensive provider and patient educational efforts. In addition, demand is strong among ENTs and allergists for patients with nasal polyps. Depixent is the fastest-growing biologic and respiratory disease treatment in our approved indications, with substantial room for growth. I'd also like to highlight efforts supporting our antibody cocktail Regen-COVE. In the first quarter, we recorded U.S. net sales of $262 million under the first contract with the U.S. government.

Matt: Regen-COVE is currently authorized under an EUA in patients based on age and risk factors, which represent close to 40% of all adults diagnosed with COVID-19. We're focused on reducing bottlenecks and increasing utilization, particularly in states with high infection rates. Efforts include direct support to key facilities, medical education about RegenCOVE, partnering with third-party stakeholders, and educating consumers on the availability of antibody treatment. As George mentioned, we're preparing for a potential update of the RegenCOVE EUA to include prevention, as we hope to be able to address an unmet need for millions of patients who may be candidates for ongoing preventative treatment.

Increased 28 per cent year over year to 673 million, primarily due to continued clinical development costs for our Gen. Cold antibody cocktail next SG&A expense increased 16 per cent your per year, the $355 million a year over year increase was driven by commercial investments for lip tile.

Costs related to the rollout of Virgin cold and higher employee related expenses.

Matt: Preventative therapy may also be important for those who have known COVID exposure and require very rapid protection. In summary, we delivered robust performance across our portfolio in the first quarter of the year. There is strong positive momentum from our in-line business, encouraging early signals from our recent launches, and substantial opportunity for continued diversified growth. Now I'll turn the call over to Bob.

Cost of goods sold increase vs. The prior year from $70 million to 173 million due to rejoin cold manufacturing costs and Praluent manufacturing costs in the U S, which were recorded by Sanofi in the first quarter of 2020. Additionally, and other income and expense, we recorded 4 million of expense compared to 25.

Income in the prior year. This is driven by interest expense related to our 2 billion dollar debt issuance.

In August 2020, and lower investment returns on our existing cash and marketable securities.

Robert E. Landry: Good morning and afternoon to everyone listening to the call. My comments today on financial results and outlook will be on a non-GAAP basis where applicable. As Len stated, Regeneron is off to a strong start in 2021 as we continue to execute across the business, delivering double-digit top and bottom line growth in the first quarter. For the first quarter, total revenues grew 38% year-over-year to $2.5 billion, driven by growth in global ILEA sales.

Finally, the effective tax rate was 10.5% in the first quarter of 2021 included in this right is the benefit achieved by a reduction in uncertain tax position liabilities related to the I R. S audits of the 2015 and 2016 cashiers.

Shifting now to cash flow and the balance sheet in the first quarter of 2021 with general generated 553 million in free cash flow and ended the quarter with net cash and marketable securities of 5.1 billion.

In the first quarter, we utilized 323 million over a 1.5 billion dollar share repurchase authorization and we remain opportunistic buyers in the market.

Robert E. Landry: Increased Sanofi collaboration profitability driven by depicts and sales of our RegenCOVE antibody cocktails, diluted net income per share grew 50% year over year to $9.89 on net income of $1.1 billion. Excluding revenues related to Regencove, Regeneron achieved 20% total revenue growth versus the prior year. As you heard from Marion, we completed our initial contract to supply Regencove to the U.S. government in the first quarter.

I would now like to provide select updates tour of 2021 guidance a complete summary of our latest for your guidance is available in our press release published earlier this morning.

We are updating full year 2021 guidance for C. O C. M. B in the range of 660 to 730 million the lower guidance range is related to the timing of contract manufacturing of Praluent for Santa fee.

Robert E. Landry: Assuming that we secure an updated EUA for the 1.2 gram treatment dose, we expect to deliver at least a million doses of Regen-COV at $2,100 per dose for our follow-on contract with the U.S. government in the second quarter. I will now move to collaboration revenues, which were $754 million in the first quarter of 2021 compared to $528 million in the first quarter of 2020. Starting with the Bayer collaboration, ex-US ILEA net product sales reported to us by Bayer were $824 million for the first quarter of 2021, representing growth of 21% on a reported basis and 12% on a constant currency basis compared to the prior year.

Robert E. Landry: Total Bayer collaboration revenue was $323 million, of which we recorded $309 million for our share of net profits from ILEA sales outside the US. Total Sanofi collaboration revenue was $365 million in the first quarter. Our share of the profits from the commercialization of Pixon and Kevzar was $261 million, which compares favorably to profits of $171 million in the prior year driven by Kevzar.

Robert E. Landry: We recorded initial Roche collaboration revenues of $67 million for our share of gross profits from the distribution of the antibody cocktail by Roche outside of the U.S. Other revenue decreased to $50 million in the first quarter, compared to $63 million in the prior year. In 2021, we expect this line to be less than half of what we recorded in 2020 due to lower BARDA reimbursements for Ebola and COVID-19. Moving on to our operating expenses, and starting with R&D.

Inquiries, which demonstrate not only the efficacy the speed of action the safety. The Tolerability, we pay really close attention to competitive coming into the marketplace and certainly in the case of the JAK inhibitors were well aware of the multiple delays also recent clinical data that is calling into question issues of safety.

Robert E. Landry: R&D increased 28% year-over-year to $673 million, primarily due to continued clinical development costs for our Regen-CoV antibody cocktail. Next, SG&A expenses increased 16% year-over-year to $355 million. The year-over-year increase was driven by commercial investments for Liptio, costs related to the rollout of Regen-CoV, and higher employee-related expenses. Cost of goods sold increased versus the prior year from $70 million to $173 million due to Regencove manufacturing costs and higher manufacturing costs in the U.S., which were recorded by Sanofi in the first quarter of 2020.

Especially at the higher doses, but even at the lower doses and the continuation of black box warnings.

You know, we hear from our key opinion leaders, who use depictions and see it as their mainstay of therapy currently and going forward with great confidence in the safety profile. This is a chronic therapy and certainly the risk of hematologic effects malignancies infection and so on.

Not something that is tolerable for them for these patients when they have a tremendous alternative so I think we feel very confident in our competitive profile going forward and also remind that depicts sense. Obviously based on it its mode of action has great efficacy across type two disease and other <unk>.

Robert E. Landry: Additionally, in other income and expense, we recorded $4 million of expense compared to $25 million of income in the prior year. This is driven by interest expense related to our $2 billion debt issuance in August 2020 and lower investment returns on our existing cash and marketable securities. Finally, the effective tax rate was 10.5% in the first quarter of 2021.

Occasions patients do sometimes have concomitant conditions. So on balance we'll stay very close to this and to our key opinion leaders and specialists, who are very very confident in the profile of a depiction.

Robert E. Landry: Included in this rate is the benefit achieved by a reduction in uncertain tax position liabilities related to the IRS audits of the 2015 and 2016 tax years. Now, moving to cash flow and the balance sheet. In the first quarter of 2021, Regeneron generated $553 million in free cash flow and ended the quarter with net cash and marketable securities of $5.1 billion. In the first quarter, we utilized $323 million of our $1.5 billion share repurchase authorization, and we remain opportunistic buyers in the market.

Yes.

Ed.

One is.

Safety will be particularly concerning.

Treatment of children.

And so I think thanks Jay.

The profile of it two pictures as shown.

It's really.

Frankly.

Okay.

Almost unparalleled in terms of what you can what you can do.

With the agent on the efficacy side.

Not have any significant concerns.

On the safety side the other the other point.

In terms of the penetration even if you look at how how these markets have evolved more agents have come on for rheumatoid arthritis and for psoriasis. The penetration is so low here that even with competition there is room for market growth rather than direct.

Robert E. Landry: I would now like to provide select updates to our 2021 guidance. A complete summary of our latest full-year guidance is available in our press release published earlier this morning. We're updating full year 2021 guidance for COCM to be in the range of $660 to $730 million. The lower guidance range is related to the timing of contract manufacturing of Pralulent for Sanofi. We are also updating guidance for our 2021 non-GAAP effective tax rate to be in the range of 13 to 15 percent.

It out.

In terms of a fixed amount of market share. So we expect a profile safety is Marion says to be moving.

Robert E. Landry: The increase from prior guidance is driven by higher forecasted delivery of Regenco under our second U.S. government contract, which is taxed at the U.S. statutory rate. In conclusion, Regeneron is off to a strong start in 2021 and continues to execute across all aspects of the business. We are well-positioned for the remainder of 2021 and will continue to make those investments necessary to ensure long-term growth. With that, I would now like to turn the call back to Justin.

Justin Helko: Mary, that concludes our prepared remarks. We'd now like to open the call for Q&A. With several callers in the queue and to ensure that we are able to address as many as possible, we will answer just one question from each caller before moving to the next. Please go ahead, Mary.

Operator: Thank you. As a reminder, to ask a question, you will need to press star followed by one on your touchtone telephone. If your question has been answered or you wish to withdraw your question, press the pound key. Please stand by for your first question. Your first question comes from the line of Terence Flynn of Goldman Sachs. Your line is now open.

Kohl's, perhaps but it but people actually trying to get away from trying to get away from that having to lather up over their entire body. The other thing about to pick something that we can never forget is that the the broad aspects of approvals across lots.

Terence C. Flynn: Great. Thanks so much for taking the time to answer the question. You know, I guess with respect to the competitive landscape for Dupixan, you know, the JAK inhibitors have been delayed, but assuming they do reach the market later this year, including at the high dose, how are you guys thinking about that as a competitive headwind for Dupixan? And maybe, you know, if you think about the longer-term market opportunity, you could walk us through kind of where penetration stands right now in the adult and Thank you.

Of allergic diseases and with a growing number is very important because these diseases do tend to run them in groups. There are many people, who have asthma and a topic dermatitis or asthma and navy pilot poses or atopic dermatitis and other allergic does.

Marion McCourt: Go ahead, Marion. Sure. So I'm happy to start off.

Marion McCourt: First, let me say that, you know, we are seeing tremendous experience with Dupixen in the marketplace today. And this obviously is across indications, including atopic dermatitis, and also, very importantly, across eight categories, which demonstrate not only the efficacy, the speed of action, the safety, the tolerability, but we pay really close attention to competitors coming into the marketplace. And certainly, in the case of the JAK inhibitors, we're well aware of the multiple delays.

Eases, which were studying so I think that our broad profile across lots of other diseases. It's also gonna give us a very strong.

Competitive position.

Next question lately.

Yeah.

Real quickly. This is Marion on that question I, just wanted to share as well that in the market experience, we do uhm and obviously like a busy day carefully through market research have a very high level of satisfaction with to pick sent for patients with atopic dermatitis. So I just wanted to make sure that there's not an impression left it there are a lot of pain.

Marion McCourt: Also, recent clinical data that is calling into question issues of safety, especially at the higher doses but even at the lower doses, and the continuation of black box warnings. But you know, we hear from our key opinion leaders who use Dupixen and see it as their mainstay of therapy currently and going forward, with great confidence in the safety profile. This is a chronic therapy, and certainly the risk of hematologic effects, malignancies, infection, and so on is just not something that is tolerable for these patients when they have a tremendous alternative.

<unk> necessarily looking for something more who are treated with you to pick some great topic dermatitis.

Go ahead.

Next question please.

Next question comes from corn bathroom, other keeping more than you right now.

Hi, Good morning, guys. Thank you for taking my question wanted to ask on the Kobe front <unk> you have a sense of the remaining hurdles and anticipated.

Me for the Lottos emergency use authorization for Origen Cove and are you continuing to ship items that the antibody cocktail as your weight on it. Thank you.

Marion McCourt: So I think we feel very confident in our competitive profile going forward. And also, I should remind you that Dupixen, you know, obviously based on its mode of action, has great efficacy across type 2 disease and other indications. Patients do sometimes have concomitant conditions. So on balance, we'll stay very close to this and to our key opinion leaders and specialists who are very, very confident in the profile of Dupixen.

Right. Thanks for that question Cory we've been in active discussions and productive discussions with the F. D. A obviously won't never knows what they're gonna do exactly when they're going to do it but we anticipate an action by the F. D. A over the next sometime in the next several weeks.

In terms of the lower one two gram dose I think from there they will turn their attention to the prevention day to which they have in front of them as well as the sub queue Ah data as well as the chronic prevention opportunity. So I I can assure you the day [laughter] D. A has been working really hard.

Leonard S. Schleifer: Yeah, I would just add two points there. One is that safety will be particularly concerning, I think, for the elderly.

Leonard S. Schleifer: So I think that the safety profile that Dupikson has shown is really, frankly, it's almost in parallel in terms of what you can do with an agent on the efficacy side and not have any significant concerns on the safety side. The other point in terms of penetration, even if you look at how these markets have evolved when more agents have come on board for rheumatoid arthritis and psoriasis, the penetration is so low here that even with competition, there is room for market growth rather than fighting it out in terms of a fixed amount of market share.

We're in constant contact with them answering questions going over things and as I said, we expect something to.

Dissipated decisions sometime in the next several weeks.

Great. Thank you.

Next question. Please Oh in an aquarium show you of course, we're continuing to supply the market.

There's no shortage of product out there in terms of people needing to be treated now can be treated with the 2.4 gram dose and there's ample product available.

Leonard S. Schleifer: So we expect...

Leonard S. Schleifer: So we expect our profile safety, as Marion says, to be really paramount in treating physicians' minds, and we do think the low level of penetration thus far does leave room for growth, nonetheless.

Perfect day.

Next question comes from Kathy.

<unk> your line is now.

So many things to ask questions about and so little time, Bob operating margin, 48% to 49%. The last couple of quarters, what would that have been.

Operator: Great. Next question, please.

Christopher Joseph Raymond: For discussion, talk from the line of Chris Raymond of Piper Chandler. Your line is now open.

Without Kobe to the antibody and isn't sustainable at the current level and all.

I'll squeeze in and it's the tax write sustainable at the current level as well thanks.

Yeah, I mean, I'll talk about the tax rate I mean, certainly there's a lot to be played out with regards to what's going to happen.

On the tax write you heard what I said, we're obviously little lower than a full year guidance. We did have you know a favorable outcome with regards to on certain tax positions that we were able to reverse which kind of drove a little lower in the quarter.

Christopher Joseph Raymond: So, you know, there's a lot of interest, I guess, in maybe looking at a topical jack or some other therapy. Just kind of curious if you guys have thought about maybe proactively.

And that's one on operating margins Jeff.

I guess, the one piece that's not so transparent to everybody is we're still incurring a lot of R&D as it pertains to reject cope with regards to the trials.

Leonard S. Schleifer: I'm kind of curious if you guys have thought about maybe proactively looking at some combination work just to sort of ensure that DuPixent maintains its role as a core. Well, George might want to comment if we have any interest in it, but in terms of the commercial side of this, you know, when you talk to patients, the kind of patients we're treating, moderate to severe atopic dermatitis, you know, they have lesions over a large fraction of their bodies.

Enrollment numbers, so I don't want people to come away and say as a result of the Roche benefit we got in the region Cove product sales that without that the margins would've been is good but we didn't curb a lot of expenses pertaining to that that aren't within the R&D line that we just don't specifically talk about.

The business on its own excluding reject code was 20% top line and 35% EBIT.

Okay. So again it shows you the underlying strained says you know as you've heard from line at the very beginning of his of his words in terms of how we're performing we thank the operating margin isn't you know it can continue to stay at that and improve at that level. I mean, certainly it's the leverage on depiction liked to the extent you saw that Sanofi did a terrific job.

Leonard S. Schleifer: I can't remember exactly what it was in our trials, but what we're seeing out there commercially is that large fractions of the body are affected by this disease. And so I think that adding topicals, perhaps, but people are actually trying to get away from, trying to get away from this disease.

Ex U S, where we're starting to get a little momentum in terms of ex U S sales those to the extent that that will continue to play out will continue to get good operating margins associated with that and then that will driver overall margins.

Leonard S. Schleifer: The other thing about Tupixen that we can never forget is that the broad aspects of approvals across lots of allergic diseases, and there are a growing number, are very important because these diseases do tend to run in groups. For example, there are many people who have asthma and atopic dermatitis or asthma and nasopolyposis or atopic dermatitis and other allergic diseases which we're studying. So I think that our broad profile across lots of other diseases is also going to give us a very strong competitive position.

Alright, Thanks Bro. Thanks, Jeff next question please.

HM HM HM HM HM HM HM HM HM HM HM HM HM.

Hey, guys. Thank you for taking my question.

On the deployment of cash could you maybe talk about the top priorities are there areas, where you would like to collaborate or bring in capabilities and I should we think about beady. Thank you.

Marion McCourt: Yeah, I just want to add real quickly, this is Marion. On that question, I just wanted to share as well that in the market experience, we do, and we obviously look at this very carefully through market research, have a very high level of satisfaction with Dupixent for patients with atopic dermatitis. So I just want to make sure that there is not an impression left that there are a lot of patients necessarily looking for something more who are treated with Dupixent for atopic dermatitis.

Wow.

Sure.

You know our our our our cash balance on a net cash basis sitting at 5.1, and we're roughly at 7 billion on a on a gross basis and again, we liked the flexibility that it affords us I always need to make sure that internally, we have enough to obviously support the internal R&D up which we continue to go after different modality and that's kind of.

Tied into our our second leg of the store where.

Where we don't have kind of in house capability on everything it's great that we have the capability for George and the beauty team to go out and get other technologies, whether it be you know you can tell you driven technology on crisper R. L nylon and the like and we're continuing to play heavy in that space and we need to make sure that things. We go after our most likely.

Corey Kazimow: The next question comes from Corey Kazimow of KP Morgan. Your line is now open.

Operator: Hey, good morning, guys. Thank you for taking my question. I wanted to ask on the COVID front, if you have a sense of the remaining hurdles and anticipated timing for the low-dose emergency use authorization for Regencov, and are you continuing to ship high doses of the antibody cocktail as you wait for it?

Gonna be early stage, we're not looking for kind of transformative kind of M&A deals on that front as of right now and we continue to stay hungry in that place with the right opportunities and then as you saw you know we did $325 million of share buybacks. We have a 1.5 billion dollar program that we authorized in January we are opportunistic buyers when.

George D. Yancopoulos: Thank you. Right. Thanks for that question, Corey. We've been in active discussion.

We think the intrinsic value of where we used to get compared to where the market is currently playing where you're going to take advantage of that of that delta and we did such that in the first quarter and we're continuing to do that on that front end that continues to be inactive play for a play for us.

unknown: [inaudible]

George D. Yancopoulos: Data as well as chronic prevention.

George D. Yancopoulos: Opportunity. So I can assure you the FDA has been working really hard. We're in constant contact with them, answering questions, and going

Ex question please.

Operator: Please see the complete disclaimer at https://sites.google.com or at www.google.com.

Next question confines happening I've been married.

No.

Hey, guys. This is Alec suggests thanks for taking our question just went on Eylea, obviously scripts and sales are holding up fairly well. Despite COVID-19, a new market entrants in the way AMD.

Operator: Next question, please. Oh, and Corey, I'm sorry, of course we're continuing to supply the market. There's no shortage of product out there in terms of people needing to be treated now can be treated with the 2.4 gram dose, and there's ample product available. Perfect. The next question comes from Jeffrey Partis of SVB Living. Your line is now open. So many things to ask questions about and so little time.

But looking to lifecycle management over the next few years do you see this primarily coming from the high dose formulation and on this is there a venue or an update on timing for data from the Kimbell a study thanks.

Yeah, I think that the lifecycle management continues to be from.

More data that kind of day to that we generated.

Jeffrey Partis: The next question comes from Jeffrey Partizop, SVB Lyric. Your line is now open.

Diabetic retinopathy with the Panorama and protocol W, which George reviewed I think a very important results and so I think that will drive more treatment in that area in terms of the high dose I think you heard from George that will get some of the preliminary phase two day that later this year and then.

Robert E. Landry: Yeah, I mean, I'll talk about the tax rate. I mean, certainly, there's a lot to be played out with regard to what's going to happen with the tax rate.

Robert E. Landry: You heard what I said, you know, we're obviously a little lower than our four-year guidance. We did have, you know, a favorable outcome with regard to uncertain tax positions that we were able to reverse, which kind of drove a little lower in the quarter on that front. On operating margins, Jeff, you know, I guess the one piece that's not so transparent to everybody is that we're still incurring a lot of R&D as it pertains to RegenCOVE with regard to the trials and the enrollment numbers.

We for next day insurance and we have Ah ready.

Readying for the clinic.

A new aversion, if you will which will unveil for you when we get that into the clinic.

Next question please.

Next question comes from having kind of got to me.

Oh HM.

Hi, Thanks, Thanks for taking my question and scared at this down [laughter] question, but you know what is your latest thought and counter detailing correct. Now what are you hearing from the specifics centers that you think might be more likely utilize the products.

Robert E. Landry: So I don't want people to come away and say, you know, as a result of the Roche benefit we got on the RegenCOVE product sales, that, you know, without that, the margins wouldn't have been as good. But we did incur a lot of expenses pertaining to that that aren't within R&D. Line that we just don't specifically talk about, you know, the business on its own, excluding RegenCOVE, was 20% top line and 35% EBIT.

And how do you counter detailed prevent that so I'm thinking any share familiar thanks.

Sure. So let me, let me say first of all.

Obviously the product you mentioned is is not approved and still at the stage, where the clinical data.

Is being reviewed as I mentioned T to some of your in the last call as we look at the clinical profile today. The first thing that we do not see a threat to eylea.

Certainly some other reasons data had some questions on clinical profile I'm certainly with an increase in iwai read question on the safety profile I think the net conclusion on the key opinion leaders that I spoke to a new retinal community was that they didn't see and.

Robert E. Landry: Okay, so again, it shows you the underlying strengths, as you've heard from Len at the very beginning of his speech in terms of how we're performing. We think the operating margin can continue to stay at that and improve at that level. I mean, certainly it's the leverage on depiction, right? To the extent that you saw that Sanofi did a terrific job on XUS, where we're starting to get a little momentum in terms of XUS sales, so to the extent that that will continue to play out, we'll continue to get good operating margins associated with that, and then that will drive our overall market. Next question.

Hobbyists benefit to the project and perhaps even questions in matching the safety durability in clinical profile of Eylea across indications I'll mentioned that certainly with idea. When are important attribute is the ability to treat and extend therapy and there's an element of that clinical trial design that constrained.

Operator: The next question comes from your team, Suniha of Guggenheim Partners. Your line is now open.

Earliest dosing interval, we actually here on a regular basis that one of the reasons why I liaise performing so well in the first quarter of 2021, and frankly perform so well last year is because of its efficacy and the ability to treat and extend for patients we remain very content and idly as profile.

Suniha: Hey guys, thank you for taking my question. I have a question on the deployment of cash. Could you maybe talk about the top priorities? Are there any areas?

Robert E. Landry: You know, our cash balance on a net cash basis sitting at 5.1, and we're roughly at 7 billion on a gross basis. And again, you know, we like the flexibility that it affords us, I always need to make sure that internally we have enough to obviously support the internal R&D, of which, you know, we continue to go after different modalities. And that's kind of tied into our second leg of the stool where You know, where we don't have kind of in-house capability on everything, it's great that we have the capability for George and the BT team to go out and get other technologies, whether it be, you know, the intelli-driven technology on CRISPR or El Nylum and the like, and we're continuing to play heavy in that space, and we need to make sure that things we go after, you know, are most likely going to be early stage.

I'm against it the competitive product you mentioned.

Next question please.

Next question comes from 80 K M. A Panther Fitzgerald your line is now.

Hey, guys. Thanks for taking my question I think that's not a progress of quarter I just wanted to talk a little about the six to 11 asthma expansion on vacation I I just need to kind of talk about how you're thinking about uptake day. It feels like it can be pretty robust in light of the safety profile and the fact that you know kids around there a topic mark as well. So I just wanted to get your perspective on that day.

Sure you mentioned something that we we look forward to and will be very much prepared for the pediatric lunch for depicts sent in the asthma market. Later this year. We do see this is a tremendous opportunities for these really long young patients eight six and up who are struggling today.

And will benefit tremendously from the the depiction ability to improve their their airways function and reduce exacerbations and help these patients and their families with these children living more long normal and healthy lives. It's very important and then at the same time.

Robert E. Landry: You know, we are opportunistic buyers when we think about the intrinsic value of where we see it compared to where the market is currently playing. We are going to take advantage of that delta, and we did so in the first quarter, and we're continuing to do so on that front. And, you know, that continues to be an active play for us.

Nizing depicts simple safety profile. So the same time, we take care of the asthma and it was learned mentioned before the possibility of concomitant diseases associated with type two disease. So we do feel that this will be a very important indication lunch, we look forward to it and it once again confirms the efficacy and the safety of detection.

Thanks Marian next question please.

Operator: Thank you. Next question, please. The next question comes from Japne FM of Bank of America. Your line is now open. Hey guys, this is Alec on for Jeff. Thanks for taking our question. Um, just one on ILEA, obviously Cripps and

Next question comes from <unk> <unk>. Your line is now all of them.

Alright, Thanks for taking my question come back to the profit.

One more question on the high growth Dionaea.

So.

All of that back in the day after that.

Hi, Mark.

Of that.

This strategy.

Okay.

But.

Good that we had.

Him then.

Scientifically y.

Oh.

Japne FM: The next question comes from Chapney FM of Bank of America. Your line is now open.

Fernando better benefits.

Just to give us some confidence.

Yeah, I think that basically a higher dose will simply.

Leonard S. Schleifer: Uh, yeah, I think that the, uh, life cycle management continues to be from, uh,

The notion is extend the duration of action that would be the primary thing that we're looking at so obviously it allows for a longer duration of action because you will go longer until you achieve the minimally effective dose. So the notion is is can we show that we will now have increased.

Leonard S. Schleifer: More data, the kind of data that we generated in diabetic retinopathy with the panorama.

Leonard S. Schleifer: and Protocol W, which George reviewed, are very important results, and so I think that will drive more treatment in that area.

Numbers of patients, who can do well with every 12 week dosing or every 16 week dosing. So that's the major goal of testing the the higher dose.

Yeah cause George saying that you know you're you're trying to extend the action, but if you look at an interval where in some patients. Let's say you take him added every weekend, but there's still some people who are not completely dry because the drug probably isn't last thing the full eight weeks, even and so you might see more drawing as a man.

Leonard S. Schleifer: In terms of the high dose, I think you heard from George that we'll get some of the preliminary Phase II data later this year. And then for next entrance, we have a readying for the clinic, a newer version, if you will, which we'll unveil for you when we get that into the clinic. Next question, please. The next question comes from Robyn Karnauskas of TruVizT. Your line is now

An infestation of the long or action. So there are a couple of ways to slice, but surely you you're looking to put more drugs and have it last longer.

Operator: The next question comes from Robyn Karnauskas of TruVizT. Your line is now open. Bye. Thanks.

Not Super has a day.

Next question please.

Your next question comes from your environment I'm, calling the line is now gray.

Robyn Kay Shelton Karnauskas: Sure, so let me say, first of all, obviously, the product you mentioned is not approved and is still at the stage where the clinical data is being reviewed. As I mentioned to some of you during the last call, as we look at the clinical profile today, on the first map, we do not see a threat to ILEA. Certainly some of the recent data had some questions on the clinical profile, and certainly with an increase in IOI rate, questions on the safety profile.

Great call Marion maybe for you on asthma can you give us a sense of what's the share now for duty and asthma and we understand that some physicians percentage of has been very aggressive in pricing.

What can you do to to offset some of that growth since et cetera. Thank you.

Sure Happy happy to take your question first I'll say, we're very pleased with the performance of depicts sent both in terms of initiations and total scripts, we haven't given details of share by indications. So I'll stay away from that specificity the day, but as you can see from our total performance and the the data shared we.

Marion McCourt: I think the net conclusion among the key opinion leaders that I spoke to in the retinal community was that they didn't see an obvious benefit to the product and perhaps even questions about matching the safety, durability, and clinical profile of ILEA across indications. I'll mention that certainly with ILEA, one of the important attributes is the ability to treat and extend therapy. And there are some elements of that clinical trial design that constrained ILEA's dosing interval.

Certainly a performing very very well in the asthma marketplace I'm not going to comment on you know other companies pricing strategies, but what I can say is when we look at the data comparing depicts an uptake either initiations are total scripts. It compares very favorably to the I O five and we we know that this as a result of.

Marion McCourt: We actually hear on a regular basis that one of the reasons why ILEA is performing so well in the first quarter of 2021 and, frankly, performed so well last year is because of its efficacy and the ability to treat and extend treatment for patients. We remain very confident in ILEA's profile against the competitive product you mentioned. Next question, please. The next question comes from Alethea Young of Canterfield Serial. Your line is now open. Hey guys, thanks for taking my question.

The the clinical profile, the safety profile and the value that not only pulmonologists, but also allergies are seeing into picks it for asthma and as you know with allergist also treating patients with can come in and diseases.

Ex question please.

Next person comes in Kenna K F. R. D C. Mark that the line is now.

Hi, Thanks for taking my question one on the picture maybe also per per Mary and it seems like dubious growing much faster than asthma benzene a D.

Operator: The next question comes from Alicia Young of Cantor Fitzgerald. Your line is now open.

Alicia Young: Sure, you mentioned something that we look forward to and will be very much prepared for the pediatric launch of DEPIXENT in the asthma market later this year. We do see this as a tremendous opportunity for these really young patients, you know, age 6 and up, who are struggling today and will benefit tremendously from DEPIXENT's ability to improve their airway function and reduce exacerbations and, you know, help these patients and their families with these children living more normal and healthy lives.

It just seems like that because jeremy such a larger sales basis. So.

Murray just wondering if you can frame what percent be pick things quarter over quarter growth is coming from asthma vs. Derm. Thank you.

Sure. So let me talk about the the total indications that that I can share with you is that the dermatology atopic dermatitis business and depicts is about 75% about 25 per cent in respiratory disease, both asthma and nasal polyps asthma of course being day.

Alicia Young: So it's very important. And then at the same time, recognizing DEPIXENT's safety profile, so at the same time, we take care of asthma and, you know, as Len mentioned before, the possibility of concomitant disease is associated with type 2 disease. So we do feel that this will be a very important indication launch. We look forward to it. And it once again confirms the efficacy and the safety of DEPIX

Larger of the two and respiratory disease, both are growing very very strongly and remembered that we launched in atopic dermatitis. Several years before we did in the asthma marketplace. Both are growing very very strongly and certainly as we look at the future potential for depicts in in atopic dermatitis, we have.

A long way to go there's still tremendous unmet need across all age groups, the youngest patients adolescents and adults and then the asthma marketplaces well, it's important to note that today about 75% of the patients and asthma going on to pick sense or biologic naive. So we're getting these new starts there's tremendous.

Marion McCourt: Thanks, Marion. Next question, please.

Operator: The next question comes from Mohit Bansal of Citigroup. Your line is now open. Great, thanks for taking my question and reporting the progress.

Mohit Bansal: Great, thanks for taking my question and comparing the progress. One more question on the high-dose ILEA.

Indus opportunity and depicts and has been one of the growers of the overall asthma biologics marketplace.

Mohit Bansal: So we do know that back in the day, George also ran a trial, a Harvard trial, which did not work out well. I understand that this trial design is a little bit different. It is not a superiority trial that you are running. But could that be helpful? That's the first question.

As mentioned a knee in response to the earlier question, we look forward to.

With an FTA approval to lunch in pediatrics later, this year, but among adults and adolescents, there's still tremendous opportunity and asthma as well those are growth engines for the product and this is without even the many indications I look forward to lunching in the future related to type two disease and like as soon as they like esophagitis and some of the other areas and al.

George D. Yancopoulos: Then, I mean, scientifically, why would a high dose result in a kind of better benefit, in your opinion?

George D. Yancopoulos: Obviously, a higher dose will simply, the notion is, extend the duration of action. That would be the primary thing that we're looking at.

Oh Gee that George mentioned in his update today.

Mary we have time for two more questions, we're gonna try to squeeze them and quickly.

George D. Yancopoulos: So obviously, it allows for a longer duration of action because you will go longer until you achieve the minimally effective dose. So the notion is, can we show that we will now have increased numbers of patients who can do well with every 12-week dosing or every 16-week dosing? So that's the major goal of testing the higher dose. Yeah, and as George is saying, you know, you're trying to extend the action, but if you look at an interval where in some patients, let's say, you take them at every eight weeks, there are still some people who are not completely dry because the drug probably isn't lasting the full eight weeks.

Sure next question comes from Brian's Fine Alright Goodbye now.

Alright. Thank you for taking my question basically a low dialing in for Brian screening. Our question is based on your partnership with and tell Ya I see that we are anticipating the first thing people crisper day, they're pretty soon and we've seen uhm get success care of with the ex people approach, maybe you can share your thoughts on that and people approach and how.

We should think about it in terms of looking at the safety of this approach not just for the H T. R indication for more badly for the proof of concept for this day. Thank you.

George I will take that yeah, I think that is the most important aspect of this for US is this as a platform and as we said we have multiple targets that might be amenable to this platform that we've already identified through our.

Operator: http://www.youtube.com or the link in the description below.

General and genetic center and so Ah.

Yaron Werber: The next question comes from Yaron Werber of Colvin. Your line is now open.

Interest will be does it work and what it will be the safety and the total very profile. So we think that this will be a.

Yaron Werber: Great. Marion, maybe for you on asthma, can you give us a sense of what the share is now for DUPI and asthma, and we understand that from physicians' perspectives?

Platform.

Determining sort of <unk>.

A result, depending on how it it turns out.

Marion McCourt: And we understand that from physicians, Placenta has been very aggressive on pricing. What can you do to...

Thanks, George we have time for one more question.

Can I just go ahead and cancel Carter gold a Barclays. Your line is now.

Marion McCourt: Sure, happy to take your question. But first, I'll say we're very pleased with the performance of Depixent, both in terms of initiations and total scripts. We haven't given details of share by indication, so I'll stay away from that specificity today. But as you can see from our total performance and the, you know, the data shared, we certainly are performing very, very well in the asthma marketplace. I'm not going to comment on, you know, other companies' pricing strategies, but what I can say is when we look at the data comparing Depixent uptake, either initiations or total scripts, it compares very favorably to the IL-5s.

Great congratulations on the quarter and thanks for all the progress in tackling covered and for taking the question.

If you think how how should we think about how how do you think about appropriate resident COVID-19 to production and increasingly sort of post vaccination world and any read into how countries that health care systems are approaching supplies stocked and stockpiling and I guess and entering that question can you just clarify kind of where are you in row stand in terms of capacity.

I can see of lower doses and continued improvements in efficiency and scale. Thank you.

Let me write that day.

I don't think we're really in a position it's better for rose to comment on how the market is developing outside of the United States.

But I do know that they're working on a lot of different discussions with a lot of different jurisdictions.

Marion McCourt: And we know that this is a result of the clinical profile, the safety profile, and the value that not only pulmonologists but also allergists are seeing in Depixent for asthma, and as you know, allergists are also treating patients with concomitant diseases.

And there is as we speak now adequate supply, but obviously.

Pandemic changes pretty quickly so.

I think roast is probably going to be better positioned to answer Mentalists, Justin has anything more specific for ya.

Operator: The next question comes from Kenny McKay of RBC Markets. Your line is now open.

Nope that's it.

Kenny McKay: Hi, thanks for taking the question. One on Dupuytren, maybe also for Marion. It seems like Dupuytren is growing much faster in asthma than

Well. Thank you for every one enjoying the call today, we still have several colors in the queue that we didn't get to we apologize for that we will follow up with you. After the call. Thanks to everyone per dialing in be safe and have a good day.

Kenny McKay: But it just seems like that's because DERM has such a larger sales basis. So, Marion, just wondering if you could frame what percent of Dupik Singh's quarter over quarter growth is coming from asthma versus DERM. Thank you.

Thank you for your participation Anthonys Conference call. This concludes the presentation you may now disconnect good day.

Marion McCourt: In atopic dermatitis, we have a long way to go. There's still tremendous unmet need across all age groups, the youngest patients, adolescents, and adults, and then the asthma marketplace as well. You know, it's important to note that today, about 75% of the patients with asthma going on depixin are biologic naive. So we're getting these new starts.

[music].

Marion McCourt: There's tremendous opportunity, and depixin has been one of the growers in the overall asthma biologics marketplace. As I mentioned in response to the earlier question, we look forward to, with FDA approval, the launch in pediatrics later this year. But among adults and adolescents, there's still tremendous opportunity for asthma as well. Both are growth engines for the product, and this is without even the many indications I look forward to launching in the future related to type 2 disease, you know, like acinophilic esophagitis and some of the other areas and allergies that George mentioned in his update today.

Operator: Mary, we have time for two more questions. We're going to try to squeeze them in quickly.

Brian Peter Skorney: The next question comes from Brian Skorney of Beard. Your line is now open. Thank you for taking our question. This is Leah Lowe dialing in for Brian Skorney.

Leonard S. Schleifer: Our question is based on your partnership with Intelia. I see that we are anticipating the first in vivo CRISPR data pretty soon, and we've seen good success here with the ex vivo approach. Maybe you can share your thoughts on the in vivo approach and how we should think about it in terms of looking at the safety of this approach, not just for the ATTR indication but more broadly for the proof of concept for this space. Thank you.

George D. Yancopoulos: Yeah, I think that is the most important aspect of this for us, that this is a platform. And as we said, we have multiple targets that might be amenable to this platform that we've already identified through our Regeneron Genetics Center. And so of great interest will be whether it works, and what will be its safety and tolerability profile. So we think that this will be a platform determining sort of a result, depending on how it turns out.

George D. Yancopoulos: Thanks, George. We have time for one more question.

Operator: The next question comes from Carter Gould of Barclays. Your line is now open. Great.

[music].

Carter Gould: Great. Congratulations on the quarter, and thanks for all the progress in tackling COVID and for taking the question. How do you think about appropriate Regeneron COVID-2 production in an increasingly sort of post-vaccination world? And any insight into how countries' health care systems are approaching supply and stockpile? And I guess in answering that question, can you just clarify kind of where you and Roche stand in terms of capacity, the efficacy of lower doses, and continued improvements in efficiency and scale? Thank you.

Justin Helko: I don't think we're really in a position that's better for Roche to comment on how the market is developing outside of the United States, but I do know that they're working on a lot of different discussions with a lot of different jurisdictions.

Justin Helko: jurisdictions. And there is, as we speak now, an adequate supply, but obviously, the pandemic changes pretty quickly. So I think Roche is probably going to be better positioned to answer that unless Justin has anything more specific.

Justin Helko: Well, thank you to everyone who joined the call today. We still have several callers in the queue that we didn't get to. We apologize for that.

Operator: We will follow up with you after the call. Thanks to everyone for dialing in. Be safe and have a good day. Thank you for your participation in today's conference call. This concludes.

Operator: Thank you for your participation in today's conference call. This concludes the presentation. You may now disconnect. Good day.

Operator: .. .. , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,. .. © The Ultimate Parody Site! Thanks for watching!

Justin Helko: Welcome to the Regeneron Pharmaceuticals First Quarter 2021 Earnings Conference Call. My name is Mary, and I will be your operator for today's call. At this time, all participants are in the listen-only mode. Later, we will conduct a question and answer session. Please note that this conference is being recorded. I will now turn the call over to Justin Helko, Vice President, Investor Relations. You may begin.

Justin Helko: Thank you, Mary. Good morning, good afternoon, and good evening to everyone listening around the globe. Thank you for your interest in Regeneron Pharmaceuticals and welcome.

Justin Helko: Welcome to the first quarter 2021 conference call. An archive of this webcast will be available.

Justin Helko: Available on our website. Joining me on the call today is Dr. Leonard Schott.

Justin Helko: President and Chief Executive Officer, Dr. George Yancopoulos, Co-Founder, President and Chief Scientific Officer, Marion McCourt, Executive Vice President and Head of Commercial, and Bob Landry, Executive Vice President and Chief Financial Officer. 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.

Justin Helko: Development Programs and Related Anticipated Milestones, Collaborations, Finances, Regulatory Matters, Payer Coverage, and Reimbursement Issues in Elections

Justin Helko: 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 period ended March 31, 2021, which we filed with the SEC earlier today.

Justin Helko: Everyone does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise. In addition, please note that both 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. Once our call concludes, Bob Landry and the IR team will be available to answer further questions. With that...

Justin Helko: With that, let me turn the call over to our President and Chief Executive Officer, Dr. Len Schleifer.

Leonard S. Schleifer: Thank you, Justin, and thank you to everyone joining today's call. We're off to a strong start in 2021, again delivering double-digit growth on the top and bottom lines. I am immensely proud of all that Regeneron continues to accomplish in the fight against COVID and for patients suffering from a variety of diseases. Our performance highlights the continued evolution, diversification, and durability of our business as we enter a new phase of growth and new product launches.

Leonard S. Schleifer: Strong performance begins with differentiated products that deliver real value for patients. Starting with ILEA, global net sales were nearly 2.2 billion, growing 17% compared to the prior year. In the U.S., sales grew 15%, reflecting continued positive momentum and execution on our strategy. We are confident in the ILEA business and expect it to remain a key growth driver for Regeneron for years to come. We are also very pleased with the performance of Dupixent in the quarter, where global sales approached $1.3 billion and grew 48%.

[music].

Leonard S. Schleifer: The brand is now annualizing sales in excess of $5 billion, yet we believe there remains considerable room for further market growth and penetration in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis. With several additional potential indications in phase 3 trials, such as eosinophilic esophagitis, and COPD, we are still in the early days of realizing the full potential of this unique pipeline in In Oncology, we are making steady progress with Libtio, as global net sales reached 101 million and grew 35% from the prior year.

[music].

Well.

Did the Regeneron Pharmaceuticals first quarter 2021 earnings conference call. My name is marrying that with your operator for today's call. At this time all participants are in a listen only mode.

Leonard S. Schleifer: While still in the very early days with these new launches, we are seeing encouraging signals on a variety of leading indicators from thought leaders, prescribers, payers, and patients. And, last but not least, we were able to deliver significant phase three outcome data for our RegenCOVE program aimed at treating and preventing COVID-19 infections. As George will outline momentarily, we have now shown that our antibody cocktail dramatically reduces hospitalizations or death in non-hospitalized COVID-infected patients and reduces symptomatic infections when given as a preventative measure. We are seeking to update our emergency use authorization to reflect these new data and uses, as well as the lower 1.2 gram dose.

We will conduct a question and answer session. Please note that this conference is being recorded I will now turn the call low Richard Justin Hauke, Huh, Vice President Investor Relations you may begin.

Thank you Mary good morning, good afternoon, and good evening to everyone listening around the globe. Thank you for your interest in Regeneron Pharmaceuticals, and welcome to the first quarter 2021 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 you accomplish co founder President and Chief Scientific Officer, Marion Mccourt Executive Vice President and head of commercial and Bob Landry Executive Vice President and Chief Financial Officer. After our prepared remarks, we will open the call for Q&A.

Leonard S. Schleifer: Thinking longer term for Regencov, we see an ongoing global need for treatment and chronic prevention of COVID disease. Despite high rates of vaccination, it's estimated that tens of millions will remain unvaccinated in the U.S. alone. And of those who are vaccinated, significant numbers will not mount a protective response, such as those who are immunocompromised or immunosuppressed.

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.

Leonard S. Schleifer: It is important to recognize Regeneron's and the biopharmaceutical industry at large's response and ongoing actions in combating COVID-19. Breakthrough vaccines and treatments are having a profound impact on the health and well-being of people in the United States and around the globe. In addition, safe and effective vaccines and treatments are enabling economic recovery. All of these critical benefits come as a result of investments that have been made in technology over decades by both the public and private sectors.

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 filings with the United States Securities and Exchange Commission, including its form 10-Q for the period ended March 31, 2021, which we filed with the SEC earlier today Regeneron does not undertake any obligation to update any forward looking statements.

Whether as a result of new information future events or otherwise. In addition, please note that the 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. Once our call concludes Bob Landry and 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 Len Schleifer.

Yeah.

Thank you Justin and thank you to everyone joining today's call.

We were off to a strong start in 2021 again, delivering double digit growth on the top and bottom lines.

I'm immensely proud of all that Regeneron continues to accomplish in the fight against COVID-19 and for patients suffering from a variety of diseases.

Our performance highlights the continued evolution diversification and durability of our business as we enter a new phase of growth and new product launches.

Strong performance begins with differentiated products that deliver real value for patients.

Starting with Eylea Global net sales were nearly $2 2 billion growing 17% compared to the prior year in the U S sales grew 15%, reflecting continued positive momentum and execution on our strategy.

Leonard S. Schleifer: Regeneron is committed to collaborating with our health care partners to take optimal advantage of the Regencov cocktail's potential health benefits. Overall, we are pleased with all that Regeneron has accomplished in the first three months of the year and look forward to continued momentum and progress across our diverse pipeline in the months to come.

We are confident in the Eylea business and expect it will remain a key growth driver for regeneron for years to come.

We are also very pleased with the performance of do pixel in the quarter with global sales approached $1 3 billion and grew 48%.

Leonard S. Schleifer: We have a diverse pipeline for the months to come. Now, I will turn the call over to George.

George D. Yancopoulos: With COVID-19 still in the headlines, I will start with our monoclonal antibody treatment, the Regen-COV cocktail.

The brand has now annualized sales in excess of 5 billion. Yes. We believe there remains considerable room for further market growth and penetration in atopic dermatitis asthma and chronic rhinosinusitis with nasal polyposis.

George D. Yancopoulos: We recently reported data from a large phase 3 outcomes trial in the outpatient setting confirming that Regen-COV reduced the risk of hospitalization or death by 70% with both the 2.4 gram and the lower 1.2 gram doses. We are pleased that, based on these data, the NIH guidelines were updated in early April to include a strong recommendation for monoclonal antibody combinations to treat outpatients with mild or moderate COVID-19, as We also have recently reported data from a large, two-part, Phase III trial of RegenCODE, with Part A in the preventative setting and Part B in recently infected patients.

With several additional potential indications in phase III trials, such as eosinophilic Esophagitis and C. O P. D. We are still in the early days of realizing the full potential of this unique pipeline in a product.

In oncology, we are making steady progress with leap Tayo as global net sales reached 101 million and grew 35% from the prior year.

George D. Yancopoulos: In Part A of the trial, RegenCo prevented 81% of symptomatic COVID-19 infections, with 93% prevention after the first week. A supportive study in healthy volunteers that explored chronic dosing showed a similar 92% prevention of infection. Notably, these results were achieved with a convenient subcutaneous formulation. Therefore, chronic prevention with our antibody cocktail may prove to be critical in the ongoing battle against this virus. Despite high rates of vaccination, it is estimated that tens of millions of Americans will remain unvaccinated and thus at risk of future infection. In addition, it is estimated that millions of Americans will not mount an adequate response to vaccines.

Importantly in February we secured two new FDA approvals for lip tayo and basal cell carcinoma, and non small cell lung cancer, which we anticipate will help fuel a new period of growth for this product that as a foundation to our oncology strategy.

While still in very early days with these new launches we are seeing encouraging signals on a variety of leading indicators from thought leaders prescribers payers and patients.

And last but not least we were able to deliver significant phase III outcome data for a re Gen Cove program aimed at treating and preventing COVID-19 infections.

George D. Yancopoulos: For example, immunocompromised individuals or organ transplant patients who suffer from certain cancers such as lymphomas, leukemias, and myelomas, or immunosuppressant therapy for their autoimmune diseases might all be candidates for chronic prevention using our antibody cocktail. Part B of this phase 3 trial in recently infected patients also showed that the subcutaneous administration of the 1.2 gram dose was also effective in reducing symptomatic disease and shorten We are anticipating the existing EUA will be amended based upon the above data to include the 1.2 gram RegenCOV dose to allow the cocktail to be used for prevention, and to include the subcutaneous formulation for ease of use.

George will outline outline momentarily, we have now shown net of antibody cocktail dramatically reduces hospitalizations or death in non hospitalized COVID-19 infected patients and reduces symptomatic infections when given as a preventative measure.

We are seeking to update our emergency use authorization to reflect these new data and uses as well as the lower one two gram dose.

Thinking longer term for re Gen Cove, we see an ongoing global need for treatment and chronic prevention of COVID-19 disease. Despite high rates of vaccination. It's estimated that tens of millions will remain unvaccinated in the U S alone and of those who are vaccinated.

Significant numbers will not Mount a protective response, such as those who are immuno compromised or immuno suppressed.

George D. Yancopoulos: Last year, we anticipated that certain variants were likely to emerge and therefore designed our current cocktail to be active against these variants. Experimental evidence suggests that our cocktail is indeed active against all current variants of concern. Similarly, in anticipation of future variants that may emerge, we are bringing additional antibodies to the clinic shortly. Moving on to ILEA.

It is important to recognize regeneron in the biopharmaceutical industry at large we sponge and ongoing actions and companion COVID-19.

Breakthrough vaccines and treatments are having a profound impact on the health and well being of people in the United States and around the globe.

In addition, safe and effective vaccines and treatments are enabling economic recovery.

George D. Yancopoulos: A recent NIH-sponsored Protocol W trial in non-proliferative diabetic retinopathy patients confirmed the results of our own panorama study. After two years, ILEA reduced vision-threatening complications by 68% compared to a group of patients who delayed treatment. A recent Regeneron follow-up analysis in a similar design panorama trial found that delaying treatment resulted in three times as many patients suffering prolonged vision loss compared to those receiving preventative ILEA treatment during a two-year period. Similar analysis has not yet been conducted for protocol W. Protocol W is the second study in diabetic retinopathy showing benefits of a less frequent ILEA dosing regimen, and we are planning on filing to expand the U.S. ILEA label by adding the 16-week dosing interval for appropriate patients in the second half of this year.

All of these critical benefits come as a result of the investments that have been made in technologies over decades by both the public and private sectors. These.

These profound effects highlight the importance of a healthy biopharmaceutical industry that fully incentivize innovation, so that new solutions to emerging disease can rapidly be invented and deployed.

We've also learned that these extraordinarily approach these extraordinary approaches to preventing and treating COVID-19 can work only if people actually received the vaccines or drugs.

For example, an internal health economic analysis projected that tens of thousands of lives in the United States could be saved over the next several months if we genco, we're fully deployed and given to all appropriate patients who are diagnosed with COVID-19, and at high risk of hospitalization or death.

George D. Yancopoulos: By year-end, we are expecting first data from the Phase 2 study testing a high dose of ILEA in wet AMD. From these data, we can expect early reads on anatomic differences and drying between the higher and lower dose at 8 and potentially 12 weeks into the study. While the study data will not be definitive on durability measures, the Phase 2 study will help provide insights on what we might expect from the Phase 3 studies, which are testing dosing intervals out to 12 and 16 weeks.

Yes.

And this is a case where cost of patients is not an issue as the government is providing the drug free of charge.

Clearly we have to better understand why a drug that has demonstrated overwhelming evidence for its ability to reduce hospitalizations or death by 70% is an ample supply has been endorsed by the NIH has been authorized under an EUA by the FDA and it's free of charge to patients.

<unk> is not being taken full advantage of <unk>.

Regeneron is committed to collaborating with our health care partners to take optimal advantage of the Regeneron Cove cocktail potential health benefits.

Overall, we are pleased and all that Regeneron has accomplished in the first three months of the year and look forward to continued momentum and progress across our diverse pipeline in the months to come.

Now I will turn the call over to George.

Okay.

Thank you Lynn.

With COVID-19 is still in the headlines.

Start with our monoclonal antibody treatment.

The coat Regina co cocktail.

Recently reported data from a large phase III outcomes trial in the outpatient setting confirming that region could reduce the risk of hospitalization or death by 70% with both the two four gram and the lower one two gram doses. We're pleased that based on these data. The NIH guidelines were updated in early April to include a strong recommendation for Mark.

The only antibody combinations to treat outpatients with mild or moderate COVID-19 as defined by the EUA criteria.

We also have recently reported data from a large two part phase III trial of region cope with par day in the preventative setting in part D and recently infected patients in part a of the trial region co prevented 81% of symptomatic COVID-19 infections with 93% prevention after the first week.

George D. Yancopoulos: We've previously announced positive data in the Part A part of our Phase 3 trial of eosinophilic esophagitis, and Part B of this trial is fully enrolled. In addition, two Phase 3 trials of Dupixen and Type 2 COPD are actively enrolling patients. A complementary program.

A supportive study in healthy volunteers that export chronic dosing showed a similar 92% prevention of infection.

Notably these results were achieved with a convenient subcutaneous formulation chronic prevention with our antibody cocktail proved to be critical in the ongoing battle against this virus. Despite high rates of vaccination is estimated at tens of millions of Americans will remain and vaccine that's at risk for future infection. In addition, it is estimated that millions of them.

Americans will not Mount an adequate response to vaccines for example, immuno compromised individuals or organ transplant patients.

Well, who suffer from certain cancers, such as lymphomas, leukemias, and myeloma, where an immunosuppressant therapies for their autoimmune diseases might all be candidates for chronic prevention using our antibody cocktail.

Part B of this phase III trial in recently infected patients showed that the subcutaneous administration of the 1.2 Gram dose was also effective in reducing symptomatic disease and shortening disease duration.

We are anticipating the existing E way will be mended based upon the above data to include the $1 two Gram region co dose to allow the couch ought to be used for prevention and to include the subcutaneous formulation for ease of use.

George D. Yancopoulos: The anti-BFV-1 antibody cocktail binds and inactivates the BFV-1 allergen that causes birch pollen allergy, one of the most common seasonal allergies that occur in the spring. Following Phase 2 data showing immediate and long-lasting effects against allergen challenge, we initiated a Phase 3 study, and results are expected later this year. Assuming success in the current study, we are planning to conduct a second phase 2 study during an upcoming birch pollen season.

We believe the current data is supportive of.

Potential formal BLA approval by the F D a.

I would like to remind everyone that outside of the United States, where some countries have been even more ongoing dire need for COVID-19 medicines, our partner Roche is rapidly expanding availability of the treatment.

Last year, we anticipated that certain parents will likely to emerge and therefore designed our current cocktail to be active against these areas.

Experimental evidence suggests that our cocktail is indeed active against all current variance of concern.

Similarly in anticipation of future variance that may emerge we are bringing additionally antibodies to the clinic shortly.

George D. Yancopoulos: Regarding our similar, similarly designed Fel-D1 antibody cocktail for the cat allele, phase II data were presented earlier this year at a Quad AI meeting showing that single administration of the antibody cocktail prevented early asthma reactions in allergic patients and prevented lung function decline upon cat allergen exposure when compared to placebo. Following this positive data update, a first phase 3 trial in cat allergy is planned for later this year. We're enthusiastic about these novel additions to our inflammation immunology portfolio that could represent new, groundbreaking ways to treat allergic diseases.

Moving onto Eylea are.

A recent NIH sponsored protocol W trial in non proliferative diabetic retinopathy patients confirmed results of our own Panorama study after two years eylea reduce vision threatening complications by 6% to 8% compared to a group of patients who delayed treatment.

The recent regeneron follow up analysis in the similar design Panorama trial than the delaying treatment resulted in three times as many patients suffering prolonged vision loss compared to those receiving preventative eylea treatment during the two year period.

Similar analysis has not yet been.

Conducted per protocol W.

Protocol W is the second study in diabetic retinopathy, showing benefit of less frequent eylea dosing regimen, and we are planning on filing to expand the U S. Eylea label by adding the 16 week dosing interval for appropriate patients in the second half of this year.

George D. Yancopoulos: Moving on to Leptile and our Oncology Portfolio, in the first quarter, Leptile was approved for the first-line treatment of certain patients with non-small cell lung cancer and for advanced basal cell carcinoma, each being crucial early milestones for our oncology strategy. In addition, a phase 3 study of Liptio in second-line cervical cancer was stopped early for an overwhelmingly positive overall survival benefit, a first for any systemic treatment in these patients. These data will be shared at an upcoming medical meeting, and regulatory submissions are planned for this year.

By year end, we're expecting first data from the phase two study testing a high dose of Eylea in wet AMD.

These data we can expect early reads on anatomic differences and drawing between the higher and lower dose at eight and potentially 12 week intervals. While the study data will not be definitive on Deborah really measures. The phase II study will help provide insights on what we might expect from the phase III studies, which are testing dosing interval out to 12 months.

16 weeks.

Importantly in the 106 patients dose in the open label Phase II study. So far we haven't seen any concerning safety signals. The phase III studies in wet AMD and <unk> are expected to be fully enrolled by the second half of this year.

George D. Yancopoulos: Additionally, we look forward to sharing an expanded data set of Pheanlamab, our anti-LAG-3 program, at the upcoming ASCO meeting. Pheanlamab is being studied in combination with Liptio in first-line melanoma. In the second half of this year, we anticipate results of an interim analysis for overall survival in our Phase III Leptile Lung Cancer Chemotherapy Combination Study. Moving on to our BISPECIFIC portfolio,

Moving onto depicts our immunology and inflammation portfolio dozens of recent presentations at key dermatology meetings highlight the ever increasing scope of depicts an efficacy and safety in patients as young as six years old, including rapid itch relief sustained improvement in disease severity.

And overall quality of life.

Importantly depicts it is not immunosuppressive.

We have not seen an increased risk of serious infections with depicts this.

This mounting wall of data and physician experience Fortifies, our fortifies our belief that depicts it will remain the preferred choice for multiple type two inflammatory diseases.

In the first quarter, we submitted data to support the use of depiction in children six to 11 years old with moderate to severe asthma. The BLA supplement has an FDA action date of October 21 of this year a similar application has been submitted in the EU.

We prudently announced positive data in the part a part of our phase III trial, eosinophilic Esophagitis and part B of this trial is fully enrolled in addition, two phase III trials. It depicts and type two COPD are actively enrolling patients.

Complementary program.

With our anti IL 33 antibody it a pick a man and a different group of COPD patients former smokers is progressing with both phase III trials now enrolling.

We believe that this broad COPD program, including the pixel and it'll pick them and may provide real benefit for many patients.

George D. Yancopoulos: Moving to lymphoma, responses to our CD20 by CD3 bispecific ogenectomab demonstrate increasing durability. Regarding the partial clinical hold on this program, we have agreed to a path forward with the FDA, submitted the updated protocol, and are expected to hear back on lifting the partial hold in the very near term. Enrollment of the follicular lymphoma and diffuse large B-cell lymphoma cohorts of the phase 2 pivotal intent trial should resume quickly thereafter.

Turning now to our novel approach to treat allergy by using cocktails of monoclonal antibodies to directly bind and inactivate the allergen.

These cocktails are designed to act immediately and to be long lasting and to replace currently cumbersome approaches to allergy desensitization that involve years of multiple weekly injections.

The anti <unk> antibody cocktail bond and inactivate the Betsy one allergen that causes birch pollen allergy one of the most common seasonal allergies that occur in the spring.

Following phase two data showing immediate and long lasting effects against allergen challenge, we initiated a phase III study and results are expected later this year.

George D. Yancopoulos: Additionally, testing of the Otronextamib subcutaneous formulation will start later this year, and the paired CoSTIM-bispecific combination is also on track to initiate within the next 12 months. Regarding our solid tumor efforts with our bispecific, ovarian cancer is the first indication for which we are already clinically testing two different types of bispecifics for the appropriate tumor target, MUX16. Dose escalation of our MUX16 by CD3 bispecific is ongoing, and we are hoping to share initial data next year, if not sooner. In the MUX16 by CD28 CoStim study, patients are dosed in combination with Leptio, and dose escalation is ongoing.

Assuming success in the current study we're planning to conduct a second phase II study during an upcoming birch pollen season.

Regarding our similar.

Similarly, designed <unk>, one antibody cocktail for cat allergy phase.

Phase II data were presented earlier this year.

Quite a <unk> meeting showing that single administration of the antibody cocktail prevented early asthma reactions in allergic patients and prevented lung function decline upon cat allergen exposure when compared to placebo.

Following this positive day to update the first phase II trial in Cat allergy is planned for later this year. We are enthusiastic about this novel additions to our inflammation and immunology portfolio that could represent new groundbreaking ways to treat allergic diseases.

Moving on to lip tile and our.

Oh ecology portfolio and.

George D. Yancopoulos: Combination of the CD3 and CD28 co-stim bi-specifics targeting MUC16 will start later this year, and it has the potential to be a game-changing strategy for treatment of these solid tumors and Prostate Cancer. PSMA by CD28 is in dose escalation studies with Liptio, and we hope to share initial data next year or sooner. As seen in our other programs, we are planning on introducing a potentially complementary CD3 biospecific to the clinic later this year, rounding out a powerful and unique toolkit for prostate cancer currently considered unresponsive to immunotherapy.

In the first quarter low Tayo was approved for the first line treatment of certain patients with non small cell lung cancer and for advanced basal cell carcinoma.

Each being crucial early milestones for our oncology strategy. In addition, a phase III study of lip Tayo in second line cervical cancer was stopped early for an overwhelmingly positive overall survival benefit.

First for any systemic treatment in these patients. These data will be shared at an upcoming medical meeting and regulatory submissions are planned for this year.

Additionally, we look forward to sharing expanded dataset of <unk>, our anti lag three program at the upcoming Astro meeting the end demand is being studied in combination with lip tile in first line melanoma.

George D. Yancopoulos: Regarding our early efforts in lung cancer and other solid tumors, our EGFR by CD2A co-stem bispecific is in the dose escalation phase, and patients are now being dosed in combination with Liptile. Our MET by MET bispecific antibody is in the dose expansion phase. Recall that this study is enrolling non-small cell lung cancer patients with a broad selection, including patients with MET, Exxon-14, gene mutations, gene amplification, and or elevated MET protein expression.

In the second half of this year, we anticipate results of an interim analysis for overall survival in our phase.

Phase III reptile lung cancer chemotherapy combination study.

Moving on to our bi specific portfolio in multiple myeloma, our BSG made by <unk> three by specific for which we now hold exclusive development rights is continuing through dose escalation and dose expansion, we expect to initiate new combination studies in earlier lines of multiple myeloma later this year.

Regeneron is uniquely positioned to mix and match multiple modalities and targets with the hope of increasing deep responses. We are already observing with the CD three by specific.

George D. Yancopoulos: We believe our oncology portfolio is one of the most exciting in the field and has the potential to revolutionize the treatment of diverse, difficult-to-treat cancers. Finally, I would like to highlight our capabilities in the Regeneron Genetic Center and our genetics and medicines efforts. In addition to being able to discover and validate targets that we can address with our Velocimin antibody platform, we're working with our collaborators to develop three additional platforms that have the potential to generate new classes of genetics-based medicine. First, gene editing.

We're planning to add a coast in bi specific to our Arsenal of clinical stage multiple myeloma investigational therapies early next year.

Moving to lymphoma responses to our CD 20 by CD three by specific Audra and ex demand demonstrate increasing durability regarding the partial clinical hold on this program. We have agreed to a path forward with the FDA submitted the updated protocol and are expected to hear back on lifting the partial hold in the very near term enrollment of the <unk>.

Lithia lymphoma, and diffuse large b cell lymphoma cohorts of the phase II pivotal intent trial should resume quickly thereafter. Additionally testing of the <unk> subcutaneous formulation will start later this year and the paired co stim Bispecific combination is also on track to initiate within the next 12 months.

George D. Yancopoulos: Target ALN HSD directed to HSD17B13. A target discovered by the Regeneron Genetic Center is now enrolling NASH patients. Additionally, we and El Nilem are collaborating on a series of follow-on targets. While the technology is currently validated for liver-directed therapeutic approaches, we are set to extend it to eye and central nervous system targets. Our third genetic medicines approach involves viral gene therapy delivery, and is another approach of significant interest and excitement

That sooner in the <unk> by CD 28, co Stim study patients are dosed in combination with lip tile and dose escalation is ongoing.

Combination of the <unk> III and CD 28, co stim Bispecific <unk> targeting <unk> 16 will start later this year and it has the potential to be a game changing strategy for treatment of these solid tumors.

In prostate cancer.

P. SMA by CD 28 is in dose escalation studies with lip tile and we hope to share initial data next year as soon as senior no. Other programs, we're planning on introducing a potentially complementary CD three by specific to the clinic later this year rounding out a powerful and unique toolkit for prostate cancer currently considered.

George D. Yancopoulos: Our first gene therapy program is in collaboration with Decibel, focusing on targeting the ear. We and Decibel are planning to enter the clinic with DB-OTO next year. In addition to the AAVs targeting the ear, we are developing a platform for use in multiple other tissues of interest.

Unresponsive to immunotherapy.

Matt: With that said, I would like to turn the call over to Matt.

Matt: Thank you, George. We're off to an exciting start in 2021. Our expanded commercial portfolio includes three recent product and indication launches, and we continue to grow our largest brands, Alia, Dipixen, and Liptayo, based on competitive and differentiated profiles. Beginning with ILEA, first quarter global net sales grew 17% year over year to nearly $2.2 billion. In the US, ILEA net sales grew 15% year over year to $1.35 billion based on increased demand and a favorable comparison to the early weeks of the pandemic in the first quarter of 2020.

Recall that this study is enrolling non small cell lung cancer patients with a broad selection.

Ah patients, including met exon 14 gene mutations gene amplification, and our elevated net protein expression.

We believe our oncology portfolio as one of the most exciting in the field and has the potential to revolutionize the treatment of diverse difficult to treat cancers.

Finally, I would like to highlight our capabilities regarding the Regeneron genetic center and our genetics medicines efforts. In addition to being able to discover and validate targets that we can address with our velocity and antibody platform. We're working with our collaborators to develop three additional platforms that have the potential to generate new classes.

A genetics based medicines first gene editing we are eagerly awaiting initial results from the first systemic based CRISPR approach to the announced mid year by our collaborator in <unk>. If positive. These results will validate this gene editing platform.

A host of genetic targets identified by the Regeneron genetic center and being investigated under our collaboration with <unk>.

Second we are also excited about our mylan collaboration with its validated SA RNA platform approach the consumer really address complementary genetics targets are on island tar.

Target.

In HST directed to <unk> 171, three a target discovered by the Regeneron Genetics Center is now enrolling Nash patients. Additionally, we and on the island, Mark Calabria, and a series of follow on targets. While the technology is currently validated for liver directed therapeutic approaches.

We are set to extend to <unk> and central nervous.

System targets.

Our third genetic medicine approach involves viral gene therapy delivery.

Matt: The vast majority of first-quarter sales were in cutaneous squamous cell carcinoma, where LibTio is the number one systemic treatment. We're excited by recent approvals in non-small cell lung cancer and basal cell carcinoma, or BCC, both of which represent meaningful growth opportunities for Leptio. In April, we deployed our expanded and highly experienced field force across these indications to extend our Leptio promotional impact.

And as another approach a significant.

Interest and excitement at Regeneron, our first gene therapy program is in collaboration with decibel, focusing on targeting the ear reimbursable or planning to enter the clinic with DB gas OTR next year. In addition to the AAV is targeting here, we are developing a platform for use in multiple other tissues of interest.

With that I would like to turn the call over to Murray.

Thank you George Ralph to an exciting start in 2021, our expanded commercial portfolio includes three recent product and indication launches and we continue to grow our largest brand in India. It takes in low tayo based on competitive and differentiated profiles.

Meaning with Eylea first quarter global net sales grew 17% year over year to nearly $2 2 billion in the U S. Eylea net sales grew 15% year over year to 135 billion based on increased demand and a favorable comparison to the early weeks of the pandemic in the first quarter of 2020.

And Liam is capturing category growth and continues to be the preferred treatment option.

Matt: Liptio is the only anti-PD1 antibody approved in advanced disease for this indication. Early feedback has been encouraging, as physicians are eager to prescribe Liptio based on its efficacy and tolerability. Hedgehog inhibitors, despite being used as first-line treatment, may not be suitable for patients for long-term or repeat use. Liptio is an important new treatment alternative for BCC patients. In summary, our Lung and BCC launches are progressing according to plan, and we are highly focused on ensuring that appropriate patients benefit from Liptio.

In the branded anti VEGF category, India has approximately 75% share and it's approaching 50% of the combined branded and unbranded category Alere is differentiated by the combination of its efficacy safety and dosing flexibility and range of indications. In addition physicians have considerable.

Real world experience with more than 40 million injections administered worldwide.

The BARDA category demand continues to improve in 2021 as patient flow normalizes and new patient volume growth. We are confident in our near and longer term outlook based on favorable patient demographics.

Matt: Turning now to APHTESA, which was also approved in the first quarter of 2021 and is in the initial launch phase. APHTESA represents a novel and effective treatment for patients with homozygous familial hypercholesterolemia and is recognized by treating specialists as an improvement over the current standard of care.

<unk> preference for Eylea growth opportunities in diabetic eye disease, and future opportunities with our high dose clinical program.

Turning to live tile first quarter global net sales grew to $101 million with U S. Net sales of $69 million. The vast majority of first quarter sales were in cutaneous squamous cell carcinoma, where lead times is the number one systemic treatment.

Matt: Patient demand is steadily building, with multiple patients already initiated on therapy. Moving to DEPIXEN, global net sales in the first quarter were 1.26 billion, representing 48% growth compared to the prior year. In the U.S., broad-based growth across all approved indications generated net sales of 962 million, with new patient starts now higher than pre-COVID levels. In atopic dermatitis, DEPIXEN's largest indication, prescribing continues to be strong across both moderate and severe disease, and across age groups following our adolescent and pediatric launches. There is significant opportunity for continued growth based on remaining unmet need among eligible patients. Dupixent is the number one dermatologist prescribed biologic based on the depth and breadth of its long-term efficacy and safety profile.

We're excited by recent approvals in non small cell lung cancer, and basal cell carcinoma, or BCC, both of which represent meaningful growth opportunities for low tayo in April we deployed our expanded and highly experienced sales force across these indications to extend our lead tier promotional impact in low.

In cancer, we have heard from oncologists that Tayo is highly competitive based on the strength of our compelling clinical data and overall value proposition.

Early launch indicators are encouraging with uptake evidenced at top academic and community based practices.

Advancing formulary placement securing favorable payer coverage decisions and growing overall market awareness importantly, mid tier was rapidly included in the MCC and guidelines with a category one preferred rating.

Matt: Turning to asthma, where we are actively preparing to launch in pediatric patients as young as six years of age later this year. Among adolescents and adults, we continue to meaningfully expand the number of patients driven by our extensive provider and patient educational efforts. In addition, demand is strong among ENTs and allergists for patients with nasal polyps. Dupixent is the fastest-growing biologic and respiratory disease treatment in our approved indications, with substantial room for growth. I'd also like to highlight efforts supporting our antibody cocktail RegenCOVE. In the first quarter, we recorded U.S. net sales of $262 million under the first contract with the U.S. government.

And CCN guidelines have also been updated to include low tayo in BCC as the category QA option retired as the only anti PD one approved in advance disease for this indication early feedback has been encouraging as physicians are eager to prescribe volatile based on its efficacy and tolerability.

Hedgehog inhibitors, despite being used as first line treatment may not be suitable for patients for long term or repeat use low tayo isn't important nuclear alternative for BCC patients in summary, along in BCC launches are progressing according to plan and we are highly focused on ensuring that appropriate patients.

<unk> benefit from low Tayo.

Turning now to a teaser which was also approved in the first quarter of 2021 and is in the initial launch phase at <unk> represents a novel and effective treatment for patients with homozygous familial hypercholesterolemia and is recognized by trading specialists as an improvement over the current standard of care.

Matt: RegenCOVE is currently authorized under an EUA in patients based on age and risk factors, which represent close to 40% of all adults diagnosed with COVID-19. We're focused on reducing bottlenecks and increasing utilization, particularly in states with high infection rates. Efforts include direct support to key facilities, medical education about RegenCOVE, partnering with third-party stakeholders, and educating consumers on the availability of antibody treatment. As George mentioned, we're preparing for a potential update of the RegenCOVE EUA to include prevention, as we hope to be able to address an unmet need for millions of patients who may be candidates for ongoing preventative treatment.

Patient demand is steadily building with multiple patients already initiated on therapy.

Moving to the pixel global net sales in the first quarter were 1.26 billion, representing 48% growth compared to the prior year in the U S. Broad based growth across all approved indications generated net sales of $962 million with the new patient starts now higher than pre COVID-19 levels.

In atopic dermatitis depictions largest indication prescribing continues to be strong across both moderate and severe disease and across age groups. Following our adolescent pediatric lunches.

There is significant opportunity for continued growth based on remaining unmet need among eligible patients <unk> is the number one dermatologist prescribed biologic based on the depth and breadth of its long term efficacy and safety profile.

Turning to asthma, where we are actively preparing to launch in pediatric patients as young as six years of age later this year.

Among adolescents and adults we continued to meaningfully expand the number of depicts and patient initiations driven by our extensive provider and patient educational efforts.

In addition demand is strong among e&ps, an allergist for patients with nasal polyps.

<unk> is the fastest growing biologic in respiratory disease in our approved indications with substantial room for growth.

I'd also like to highlight effort supporting our antibody cocktail for Gen curve in the first quarter, we recorded U S. Net sales of $262 million under the first contract with U S government.

<unk> is currently authorized under EUA in patients based on age and risk factors, which represent close to 40% of all adults diagnosed with COVID-19, we're focused on reducing bottlenecks and increasing utilization, particularly in states with high infection rates.

Robert E. Landry: Increased Sanofi collaboration profitability driven by depicts and sales of our Regencove antibody cocktail. Diluted net income per share grew 50% year over year to $9.89 on net income of $1.1 billion. Excluding revenues related to Regencove, Regeneron achieved 20% total revenue growth versus the prior year. As you heard from Marion, we completed our initial contract to supply Regencove to the U.S. government in the first quarter.

Efforts include direct support to key facilities medical education about <unk> partnering with third party stakeholders and educating consumers on the availability of antibody treatments.

George mentioned, we are preparing for a potential update of the re gen curve EUA to include prevention as we hope to be able to address an unmet need for millions of patients who may be candidates for ongoing preventative treatment preventative therapy may also be important for those who have known COVID-19 exposure.

Robert E. Landry: Assuming that we secure an updated EUA for the 1.2 gram treatment dose, we expect to deliver at least a million doses of Regen-COV at $2,100 per dose, or our follow-on contract with the U.S. government in the second quarter. I will now move to collaboration revenues, which were $754 million in the first quarter of 2021 compared to $528 million in the first quarter of 2020. Starting with the Bayer collaboration, ex-US ILEA net product sales reported to us by Bayer were $824 million for the first quarter of 2021, representing growth of 21% on a reported basis and 12% on a constant currency basis compared to the prior year.

And require a very rapid protection in summary, we delivered robust performance across our portfolio in the first quarter of the year Theres strong positive momentum from our in line business encouraging early signals from our recent launches and substantial opportunity for continued diversified growth now I will turn the call over to Bob.

Thanks, Marion and good morning, and afternoon to everyone listening to the call. My comments today are on on financial results and outlook will be on a non-GAAP basis, where applicable.

As <unk> stated Regeneron is off to a strong start in 2021, as we continue to execute across the business delivering double digit top and bottom line growth in the first quarter.

Diluted net income per share grew 50% year over year to $9 89.

On net income of $1 1 billion, excluding revenues related to reject Cove Regeneron achieved 20% total revenue growth versus the prior year as you heard from Marion We completed our initial contract to supply Virgin code to the U S government in the first quarter.

Assuming that we secure an updated EUA for the $1 two gram treatment dose, we expect to deliver at least 1 million doses of Virgin coal at 'twenty $100 per dose.

For our follow on contract with the U S government in the second quarter.

I will now move to collaboration revenues, which were $754 million in the first quarter of 2021 compared to $528 million in the first quarter of 2020, starting with the Bayer collaboration ex U S. Eylea net product sales reported to us by Bayer were $824 million for the first quarter of 2021.

Representing growth of 21% on a reported basis and 12% on a constant currency basis compared to the prior year total Bayer collaboration revenue was $323 million of which we recorded $309 million per our share of net profit from Eylea sales outside the U S.

Robert E. Landry: R&D increased 28% year-over-year to $673 million, primarily due to continued clinical development costs for our Regencove antibody cocktail. Next, SG&A expenses increased 16% year-over-year to $355 million. The year-over-year increase was driven by commercial investments for Liptio, costs related to the rollout of Regencove, and higher employee-related expenses. Cost of goods sold increased versus the prior year from $70 million to $173 million due to Regencove manufacturing costs and Pharmaceutical Manufacturing Costs in the U.S., which were recorded by Sanofi in the first quarter of 2020.

Total Sanofi collaboration revenue was $365 million in the first quarter our share of the profit from the commercialization of the pixel <unk> was 261 million, which compares favorably to profit of $171 million in the prior year driven by depiction.

We recorded initial Roche collaboration revenues of $67 million for our share of gross profit from the distribution of the antibody cocktail by Roche outside of the U S. Other.

Other revenue decreased to $50 million in the first quarter compared to $63 million in the prior year in 2021, we expect this line to be less than half of what we recorded in 2020 due to lower BARDA reimbursements for the <unk> and COVID-19 programs.

Moving onto our operating expenses and starting with R&D R&D increased 28% year over year to $673 million, primarily due to continued clinical development costs for our region cold antibody cocktail next SG&A expense increased 16% year over year to $355 million.

The year over year increase was driven by commercial investments for lip tayo costs related to the rollout of <unk> and higher employee related expenses.

Cost of goods sold increased versus the prior year from $70 million to $173 million due to rejoin co manufacturing costs in praluent manufacturing costs in the U S, which were recorded by <unk> in the first quarter of 2020.

Additionally, in other income and expense, we recorded $4 million of expense compared to $25 million of income in the prior year. This is driven by interest expense related to our $2 billion debt issuance.

In August 2020, and lower investment returns on our existing cash and marketable securities.

Finally, the effective tax rate was 10, 5% in the first quarter of 2021 included in this rate is the benefit achieved by a reduction in uncertain tax position liabilities related to the IRS audits of the 2015 and 2016 tax years.

Shifting now to cash flow and the balance sheet in the first quarter of 2021, Regeneron generated $553 million in free cash flow and ended the quarter with net cash and marketable securities of $5 1 billion.

Robert E. Landry: I would now like to provide select updates to our 2021 guidance. A complete summary of our latest full-year guidance is available in our press release published earlier this morning. We're updating full year 2021 guidance for COCM to be in the range of $660 to $730 million. The lower guidance range is related to the timing of contract manufacturing of Pralulin for Sanofi. We are also updating guidance for our 2021 non-GAAP effective tax rate to be in the range of 13 to 15 percent.

In the first quarter, we utilized $323 million over one 5 billion share repurchase authorization and we remain opportunistic buyers in the market.

I would now like to provide select updates to our 2021 guidance a complete summary of our latest full year guidance is available in our press release published earlier this morning.

We are updating full year 2021 guidance for <unk> to be in the range of $660 to $730 million. The lower guidance range is related to the timing of contract manufacturing of <unk> for <unk>.

We are also updating guidance for our 2021 non-GAAP effective tax rate to be in the range of 13% to 15%. The increase from prior guidance is driven by higher forecasted delivery of <unk> under our second U S government contract, which is taxed at the U S statutory rate.

In conclusion Regeneron is off to a strong start in 2021 and continues to execute across all aspects of the business. We are well positioned for the remainder of 2021 and continue to make those investments necessary to ensure long term growth with that I would now like to turn the call back to Justin.

Justin Helko: Thank you, Bob. Mary, that concludes our prepared remarks. We'd now like to open the call for Q&A. With several callers in the queue, and to ensure that we are able to address as many as possible, we will answer just one question from each caller before moving to the next. Please go ahead, Mary.

Thank you Bob marry that concludes our prepared remarks, we'd now like to open the call for Q&A with several callers in the queue and to ensure that we are able to address as many as possible. We will answer just one question from each caller before moving to the next please go ahead Barry.

Operator: Thank you. As a reminder, to ask a question, you will need to press star followed by 1 on your touchtone telephone. If your question has been answered or you wish to withdraw your question, press the pound key. Please stand by for your first question. Your first question comes from the line of Terence Flynn of Goldman Sachs. Your line is now open.

Thank you as a reminder to ask a question you will need to press star followed by one on your thoughts film peloton is a question has been answered or you wish to retain all your question press the pound key.

Standby for your first question.

Your first question comes from the line of day plenty of Goldman Sachs. Your line is now open.

Terence C. Flynn: Great, thanks so much for taking the question. You know, I guess with respect to the competitive landscape for Dupixent, the JAK inhibitors have been delayed, but as...

Great. Thanks, so much for taking the question.

I guess with respect to the competitive landscape for <unk> in the JAK inhibitors have been delayed but assuming they do reach the market later this year.

unknown: [inaudible]

Including at the high dose how are you guys thinking about that as a competitive headwind to the pixel and then maybe.

unknown: and in the adolescent setting. Thank you.

Marion McCourt: Go ahead, Marion. Sure. So I'm happy to start off.

As you think about the longer term market opportunity you could walk us through kind of where penetration stands right now in the in the adult and adolescent setting. Thank you.

Marion McCourt: First, let me say that, you know, we are seeing tremendous experience with Dupixent in the marketplace today. And this obviously is across indications, including atopic dermatitis, and also, very importantly, across age categories, which demonstrate not only the efficacy, the speed of action, the safety, the tolerability, but we pay really close attention to competitors coming into the marketplace. And certainly, in the case of the JAK inhibitors, we're well aware of the multiple delays.

Go ahead Barry share so.

I'm happy to start off first let me say that we are seeing tremendous experience with depiction in the marketplace today and this obviously is across indications, including atopic dermatitis and also very importantly across age categories, which demonstrate not only the efficacy the speed of that.

Action the safety Tolerability, we pay really close attention to competitive coming into the marketplace and certainly in the case of the JAK inhibitors were well aware of the multiple delays also recent clinical data that is calling into question issues of safety, especially at the higher doses, but even at the lower doses.

Marion McCourt: Also, recent clinical data that is calling into question issues of safety, especially at the higher doses but even at the lower doses, and the continuation of black box warnings. But you know, we hear from our key opinion leaders who use Dupixent and see it as their mainstay of therapy currently and going forward with great confidence in the safety profile. This is a chronic therapy, and certainly the risk of hematologic effects, malignancies, infection, and so on is just not something that is tolerable for these patients when they have a tremendous alternative.

And the continuation of Black box warnings.

We hear from our key opinion leaders, who used to pick sense and see it as their mainstay of therapy currently and going forward with great confidence in the safety profile. This is a chronic therapy and certainly the risks of hematologic effects malignancies infection and so on.

Not something that is tolerable for them for these patients when they have a tremendous alternative.

Marion McCourt: So I think we feel very confident in our competitive profile going forward and also remind you that Dupixent, you know, obviously based on its mode of action, has great efficacy across type 2 disease and other indications. Patients do sometimes have concomitant conditions. So on balance, we'll stay very close to this and to our key opinion leaders and specialists who are very, very confident in the profile of Dupixent.

So I think we feel very confident in our competitive profile going forward and also remind that it makes sense, obviously based on it.

Motive action has great efficacy across type two disease and other indications patients do sometimes have concomitant conditions. So on balance we'll stay very close to this and to our key opinion leaders and specialists, who are very very confident in the profile depiction.

Leonard S. Schleifer: Yeah, I would just add that two points. One is safety, which will be particularly concerning, I think, for the long-term treatment of children. And so

Yes, I would just add.

Two points one is the.

Safety will be particularly concerning I think for the long term treatment of children.

And so I think.

Leonard S. Schleifer: So I think the safety profile that Dupixent has shown is really, frankly, it's almost unparalleled in terms of what you can do with an agent on the efficacy side and not have any significant concerns.

Safety profile with two picks and has shown.

Is really.

Frankly.

It's almost unparalleled in terms of what you can what you can do.

With the agent on the efficacy side.

Not have any significant concerns.

On the safety side the other the other point.

Leonard S. Schleifer: The other point in terms of penetration, even if you look at how these markets have evolved when more agents have come on board for rheumatoid arthritis and psoriasis, the penetration is so low here that even with competition, there is room for market growth rather than fighting it out in terms of a fixed amount of market share. So we expect our profile safety, as Marion says, to be really paramount in treating physicians' minds, and we do think the low level of penetration thus far does leave room for growth nonetheless.

In terms of the penetration even if you look at how how these markets have evolved when more agents have come on for rheumatoid arthritis and for psoriasis.

The penetration is so low here that even with competition there is room for market growth rather than direct.

It out.

In terms of a fixed amount of market share. So we expect a profile safety is Marion says to be really paramount and treating physicians minds and we do think the low level of penetration thus far that does leave room for growth Nonetheless.

Operator: Great. Next question, please.

Great next question please.

Christopher Joseph Raymond: This question comes from the line of Chris Raymond of Cypress Handler. Your line is now open.

Next question comes from the line of Chris Raymond of Piper.

Sandler Your line is now open.

Christopher Joseph Raymond: Yeah, thanks. You know, just, um, maybe another question I should pick since our checks indicate there's a lot of interest in an ad with regard to add-on therapy and that there are a lot of Dupixent patients who may not necessarily be optimally managed but are not exactly failing. So, you know, there's a lot of interest, I guess, in maybe looking at a topical jack or some other therapy. Just kind of curious if you guys have thought about maybe proactively looking at some combo work to sort of ensure that DuPixent maintains its role as a core.

Yes, Thanks, Tom.

Maybe another question on <unk>, so our checks.

Indicate there's a lot of interest in <unk>.

With.

Regard to add on therapy.

And that Theres a lot of depicts in patients who may not be necessarily optimally managed but are not exactly failing.

No.

There's a lot of interest I guess with maybe looking at a topical JAK or some other therapy.

Just kind of curious if you guys have thought about maybe proactively looking at some combo work.

Just to sort of ensure that <unk> maintains its role as a core.

Christopher Joseph Raymond: This is a picture that depicts and maintains its role as a core.

Thanks.

Well.

George you might want to comment if we have any interest in it but.

Leonard S. Schleifer: Well, George might want to comment if we have any interest in it, but in terms of the commercial side of this, you know, when you talk to patients, the kind of patients we're treating, moderate to severe atopic dermatitis, you know, they have lesions over a large fraction of their bodies. I can't remember exactly what it was in our trials, but what we're seeing out there commercially is that large fractions of the body are affected by this disease. And so I think that adding topicals is, perhaps, but people are actually trying to get away from it.

In terms of the commercial side of this.

When you talk to patients.

The kind of patients we're treating moderate to severe.

Topic dermatitis.

Now they have lesions over large fraction of the body I can't remember exactly what it was in our trials, but what we're seeing out there commercially as large fractions of the body.

Are affected by this disease, and so I think that added topicals, perhaps but it but people are actually trying to get away from.

Trying to get away from that.

Having to lather up over their entire body the other.

Thinking about depiction that we can never forget is that the the broad aspects of approvals across lots of allergic diseases with a growing number.

Leonard S. Schleifer: The other thing about Dupixent that we can never forget is that the broad aspects of approvals across lots of allergic diseases, with a growing number, are very important because these diseases do tend to run in groups.

Very important because these diseases do tend to run.

And groups there are many people, who have asthma, and atopic dermatitis, asthma, and nasal polyposis or atopic dermatitis and other type of allergic diseases, which we are studying so I think that our broad profile across lots of other diseases is also going to give us a very strong comparator.

Leonard S. Schleifer: There are many people who have asthma and atopic dermatitis, or asthma and nasal polyposis, or atopic dermatitis, and other allergic diseases which we're studying. So I think that our broad profile across lots of other diseases is also going to give us a very strong competitive position.

All of our position.

Marion McCourt: I just want to add really quickly, this is Marion. On that question, I just wanted to share as well that in the market experience, we do, and we obviously look at this very carefully through market research, have a very high level of satisfaction with Dupixent for patients with atopic dermatitis. So I just want to make sure that there is not an impression left that there are a lot of patients necessarily looking for something more who are treated with Dupixent for atopic dermatitis.

Next question please.

Yes, I think that's going to add real quickly. This is marion on that question I just wanted to share as well that in the market experience. We do obviously look at those very carefully through market research.

Have a very high level of satisfaction with depicts cent per patients with atopic dermatitis. So I just wanted to make sure that there's not an impression left but there are a lot of patients necessarily looking for something more who are treated with <unk> for atopic dermatitis.

Operator: The next question comes from Kari Vazimov of KP Morgan. Your line is now open.

Good day.

Next question please.

Next question comes from Cory <unk> with Jpmorgan. Your line is now.

Kari Vazimov: Hey, good morning, guys. Thank you for taking my question. I wanted to ask on the COVID front, if you have a sense of the remaining hurdles and anticipated timing for the low-dose emergency use authorization for Regencov, and are you continuing to ship high doses of the antibody cocktail as you wait for it?

Hey, good morning, guys. Thank you for taking my question wanted to ask on the COVID-19 front, you have a sense of the remaining hurdles and anticipated.

Timing for the low dose emergency use authorization for our Regina Cove and are you continuing to ship high doses of the antibody cocktail as you wait on it. Thank you.

Operator: Thank you. Right. Thanks for that question, Corey. We've been in active discussion.

Alright, Thanks for that question Corey.

We've been in active discussions and productive discussions with the FDA, obviously, one never knows what theyre going to do exactly when they're going to do it but.

George D. Yancopoulos: Thank you for your questions and productive discussions with the FDA.

But we anticipate it.

unknown: [inaudible] I can assure you that the FDA has been working really hard. We're in constant contact with them, answering questions, and going over things.

Action by the FDA.

Over the next sometime in the next several weeks in terms of the lower one two gram dose I think from there they will turn their attention to the prevention data, which they have in front of them as well as the sub Q.

George D. Yancopoulos: Contact with them, answering questions, going over things, and as I said, we expect something to, anticipated decisions sometime in the next several weeks.

Data as well as the chronic prevention opportunity so.

Operator: Next question please. Oh, and Corey, I'm sorry. Of course, we're continuing to supply the market; there's no shortage of product out there in terms of people needing to be treated now can be treated with the 2.4 gram dose, and there's ample product available.

I can assure you Jay.

He has been working really hard.

We are in constant contact with them answering questions going on with things.

And as I said, we expect something too.

Dissipated decision sometime in the next several weeks.

Great. Thank you.

Next question, please and Cory I'm, sorry of course, we're continuing to supply the market.

Operator: There is ample product available. Perfect. The next question comes from Jeffrey Parches of SVB Living. Your line is now open. So many things to ask questions about and so little time.

There is no shortage of product out there in terms of people needing to be treated now can be treated with the two four gram dose and there's ample product available.

Perfect.

Jeffrey Parches: The next question comes from Jeffrey Parches of SVB Living. Your line is now open.

Thanks.

Next question comes from Jeffrey <unk> from SVP Leerink. Your line is now open.

Robert E. Landry: Yeah, I mean, I'll talk about the tax rate. I mean, certainly, there's a lot to be played out with regard to what's going to happen with the tax rate.

So many things to ask questions about so little time.

Bob operating margin, 48% to 49% the last couple of quarters, what would that have been.

Robert E. Landry: You heard what I said, you know, we're obviously a little lower than our full-year guidance. We did have, you know, a favorable outcome with regard to uncertain tax positions that we were able to reverse, which kind of drove a little lower in the quarter on that front. On operating margins, Jeff, you know, I guess the one piece that's not so transparent to everybody is that we're still incurring a lot of R&D as it pertains to RegenCOVE with regard to the trials and the enrollment numbers.

Without COVID-19 to the antibody and is it sustainable at the current level and.

I'll squeeze in and is the tax rate sustainable at the current level as well thanks.

Yeah, I mean, I'll talk about the tax rate I mean, certainly theres a lot to be played out with regards to what's going to happen.

On the tax rate you heard what I said, you know, we're obviously a little lower than our full year guidance, we did have.

A favorable outcome with regards to uncertain tax positions that we were able to reverse which kind of drove a little lower in the quarter.

On that front on operating margins Jeff.

I guess, the one piece that is not so transparent to everybody as we're still incurring a lot of R&D as it pertains to rejoin cope with regards to the trials the enrollment numbers. So I don't want people to come away and so you know as a result of the Roche benefit we got in the Regeneron.

Robert E. Landry: So I don't want people to come away and say, you know, as a result of the Roche benefit we got on the RegenCOVE product sales, that, you know, without that, the margins wouldn't have been as good. But we did incur a lot of expenses pertaining to that that are within R&D. Line that we just don't specifically talk about, you know, the business on its own, excluding RegenCOVE, was 20% top line and 35% EBIT.

Alex sales that without that.

The margins would have been as good but we did incur a lot of expenses pertaining to that that are within the R&D line that we just don't specifically talk about the business on its own excluding <unk> was 20% top line and 35% EBIT.

Robert E. Landry: Okay, so again, it shows you the underlying strength, as you've heard from Len at the very beginning of his speech in terms of how we're performing. We think the operating margin can continue to stay at that and improve at that level. I mean, certainly, it's the leverage on depiction, right? To the extent that you saw that Sanofi did a terrific job with XUS, where we're starting to get a little momentum in terms of XUS sales. So to the extent that that will continue to play out, we'll continue to get good operating margins associated with that, and then that will drive our overall market.

Okay. So again it shows you the underlying strength.

As you've heard from line at the very beginning of his of his words in terms of how we're performing.

We think the operating margin isn't it can continue to stay at that and improve at that level. I mean, certainly it's the leverage on depiction right to the extent you saw that <unk> did a terrific job ex U S, where we're starting to get a little momentum in terms of ex U S. Sales. So to the extent that that will continue to play out we will continue to get good operating margins.

Associated with that and then that will drive our overall margins.

Operator: Great. Thanks, Bob. Thanks, Jeff. Next question, please.

Alright, Thanks, Paul Thanks, Jeff next question please.

Suniha: The next question comes from your team, Suniha of Guggenheim Partners. Your line is now open. Hey guys, thank you for taking my question. I have a question on the deployment of cash.

Next question comes from.

Of Guggenheim Partners. Your line is now.

Hey, guys. Thank you for taking my question a question on the deployment of cash could you maybe talk about the top priorities are there areas, where you would like to collaborate or bring in capabilities and how should we think about BD. Thank you.

Suniha: Hey guys, thank you for taking my question. I have a question on the deployment of cash. Could you maybe talk about the top priorities? Are there areas where you would like to collaborate?

Wow.

Sure.

Our cash balance on a net cash basis sitting at five one and we're roughly at $7 billion on a gross basis and again, we like the flexibility that it affords us I always need to make sure that internally, we have enough to obviously support the internal R&D of which we continue to go after different modalities and thats kind of tough.

Right into our second leg of the store where.

Where we don't have kind of in house capability on everything it's great that we have the capability for George in the BT team to go out and get other technologies, whether it be the.

Can tell you driven technology on CRISPR or El nylon and the like and we're continuing to play heavy in that space than we need to make sure that things. We go after are most likely going to be early stage, we're not looking for kind of transformative kind of M&A deals on that front as of right now and we continue to stay hungry in that place with the right opportunities.

Robert E. Landry: We're not looking for kind of transformative, kind of M&A deals on that front as of right now, and we continue to stay hungry in that place with the right opportunities. And then, as you saw, we did $325 million in share buybacks. We have a $1.5 billion program that we authorized in January. You know, we are opportunistic buyers when we think about the intrinsic value of where we see it compared to where the market is currently playing. We are going to take advantage of that delta, and we did so in the first quarter, and we're continuing to do so on that front.

And then as you saw we did $325 million of share buybacks, we have a $1 $5 billion program that we authorized in January we are opportunistic buyers we think.

The intrinsic value of where we see good compared to where the market is currently playing we are going to take advantage of that.

Of that Delta and we did such that in the first quarter and we're continuing to do that on that front and that continues to be inactive play for a play for us.

Operator: Thank you for playing for us. Thank you. Next question, please. The next question comes from Japne FM of Bank of America. Your line is now open. Hey, guys, this is Alec on for Jeff. Thanks for taking our question. Just one on ILEA, obviously, scripts and sales.

Okay. Thanks, Bob ex question. Please.

Next question comes from Chad.

Bank of America. Your line is now open.

Hey, guys. This is Alex on for Jeff Thanks for taking our question.

Just one on Eylea, obviously scripts and sales are holding up fairly well, despite COVID-19, and new market entrants in wet AMD.

But looking to lifecycle management over the next few years do you see this primarily coming from the high dose formulation and unnecessary venue or an update on timing for data from the <unk> study. Thanks.

Japne FM: The next question comes from Chapney FM of Bank of America. Your line is now open.

Leonard S. Schleifer: Uh, yeah, I think that the, the, uh...

Leonard S. Schleifer: Life Cycle Management continues to be driven by more data; the kind of data that we generated in Diabetic Retinopathy with the Panorama and Protocol W, which George reviewed, I think are very important results. And so I think that will drive more treatment in that area. In terms of the high dose, I think you heard me say...

Yes, I think that the.

Lifecycle management continues to be from.

Jay does it kind of data that we generated.

<unk>.

Diabetic retinopathy with the Panorama.

The protocol W, which George reviewed I think a very important results.

And so I think that will drive more treatment in that area in terms of the high dose I think you've heard from George that we'll get some of the preliminary phase two data later this year.

Leonard S. Schleifer: Preliminary Phase II data later this year, and then for next entrance, we have a readying for the clinic, a newer version, if you will, which we'll unveil for you when we get it.

And then for next day entrance and we have ready for the clinic.

A newer version if you will which will unveil for you.

Leonard S. Schleifer: which we'll unveil for you when we get that into the clinic. Next question, please. The next question comes from Robyn Karnauskas of Trulist. Your line is now open.

When we get that into the clinic.

Next question please.

Next question comes from Robyn Curnow, Scott Childress to your line is now open.

Hi, Thanks for taking my question and scared assets.

Operator: The next question comes from Robyn Karnauskas of Trulist. Iran is now open. Guys, thanks.

My question, but you know what is your latest thought on counter detailing or what are you hearing from.

Robyn Kay Shelton Karnauskas: Sure, so let me say, first of all, obviously, the product you mentioned is not approved and is still at the stage where the clinical data is being reviewed. As I mentioned to some of you who were on the last call, as we look at the clinical profile today at FirstMap, we do not see a threat to ILEA. Certainly, some of the recent data had some...

Specific centers that you think might be more likely utilize the product.

And how do you counter detail and prevent them from taking any share from eylea.

Sure. So let me, let me say first of all.

You know obviously the product you mentioned is is not approved and still at the stage, where the clinical data.

Is being reviewed.

As I mentioned to some of you on the last call as we look at the clinical profile today are first snap, we did not see a threat to eylea.

Certainly some of the recent data.

<unk> had some.

Marion McCourt: Questions on the clinical profile and, certainly, with an increase in IOI rate, questions on the safety profile. I think the net conclusion of the key opinion leaders that I spoke to in the retinal community was that they didn't see an obvious benefit to the product and perhaps even questions about matching the safety, durability, and clinical profile of ILEA across indications. I'll mention that certainly with ILEA, one of the important attributes is the ability to treat and extend therapy.

Question on clinical profile, and certainly with an increase in iwai rate question on the safety profile.

I think the net conclusion on the key opinion leaders that I spoke to in the retinal community was that they didn't see an obvious.

<unk> to the project and perhaps even questions in matching the safety durability and clinical profile of eylea across indications.

Mentioned that certainly with Eylea when an important attribute is the ability to treat and extend therapy and other some elements of that clinical trial design that constrained eylea dosing interval.

Marion McCourt: And there are some elements of that clinical trial design that constrained ILEA's dosing interval. But we actually hear on a regular basis that one of the reasons why ILEA is performing so well in the first quarter of 2021 and, frankly, performed so well last year is because of its efficacy and the ability to treat and extend for patients. We remain very confident in ILEA's profile against the competitive product you mentioned. Next question, please. The next question comes from Alethea Young of Counterfeit Serial. Your line is now open. Hey guys, thanks for taking my question.

We actually hear on a regular basis that one other reasons why Lee is performing so well in the first quarter of 2021, and frankly perform so well last year is because of its efficacy and the ability to treat and extend for patients. We remain very constant net lease profile against the competitive product you mentioned.

<unk>.

Next question please.

Next question comes from Alethia Young of Cantor Fitzgerald. Your line is now open.

Hey, guys. Thanks for taking my question I think that some other progress this quarter I just want to talk a little bit about the six to 11 asthma expansion indications.

I just can you kind of talk about how you're thinking about uptake there it sounds like it could be pretty robust in light of the safety profile and the fact that kids are on there any topic, mark as well, but just wanted to get your perspective on that.

Operator: The next question comes from Alethea Young of Panther Fitzgerald. Your line is now open.

Alethea Young: Sure, you mentioned something that we look forward to and will be very much prepared for the pediatric launch of Dupixent in the asthma market later this year. We do see this as a tremendous opportunity for these really young patients, you know, age six and up, who are struggling today and will benefit tremendously from Dupixent's ability to improve their airway function and reduce exacerbations and, you know, help these patients and their families with these children living more normal and healthy lives.

Sure you mentioned something that we look forward to and will be very much prepared for the pediatric launch for <unk> in the asthma market later this year.

We do see this is a tremendous opportunities for these really young patients aged six and up who are struggling today and will benefit tremendously from D day.

It depicts and ability to improve their their airways function and reduce exacerbations and help these patients and their families with these children.

Living more normal and healthy lives, it's very important and then at the same time recognizing depicts since safety profile. So the same time, we take care of the asthma and as Len mentioned before the possibility of concomitant diseases associated with type two disease. So we do feel that this will be a very important indication launch.

Alethea Young: So it's very important. And then at the same time, recognizing Dupixent's safety profile, so at the same time, we take care of asthma and, you know, as Len mentioned before, the possibility of concomitant disease is associated with type 2 disease. So we do feel that this will be a very important indication launch. We look forward to it. And it once again confirms the efficacy and the safety of Dupix

We look forward to it and it once again confirms the efficacy and the safety and protection.

Marion McCourt: Thanks, Marion. Next question, please.

Thanks, Marion next question please.

Operator: The next question comes from Mohit Bansal of Citigroup. Your line is now open. Great, thanks for taking my question and comparing the progress.

Next question comes from Amit <unk>.

Your line is now open.

Alright, Thanks for taking my question and come back to the profit.

Mohit Bansal: Great, thanks for taking my question and comparing the progress. One more question on the high-dose ILEA.

One more question on the high dose Eylea.

So we do know that back into the portfolio of assets.

Mohit Bansal: So we do know that back in the day, Josh also ran a trial, a Harvard trial, which did not work out well. I understand that this trial design is a little bit different. It is not a superiority trial that you are running. But could that be helpful? That's the first question. Then, I mean, scientifically, why would a high dose result in a kind of microbiometric, in your opinion?

Hardwood trial, you're talking about Carlsbad.

This product design.

Mark you drive that you've let Ronnie.

But.

Good that Hudson.

Scientifically why with the highest growth.

Santander Banco benefit.

Net.

Thank you.

Yeah, I think that basically a higher dose will simply.

George D. Yancopoulos: A higher dose will simply, the notion is, extend the duration of action. That would be the primary thing that we're looking at.

George D. Yancopoulos: So obviously, it allows for a longer duration of action because you will go longer until you achieve the minimally effective dose. So the notion is, can we show that we will now have increased numbers of patients who can do well with every 12-week dosing or every 16-week dosing? So that's the major goal of testing the higher dose. Yeah, and as George is saying, you know, you're trying to extend the action, but if you look at an interval where, in some patients, let's say, you take them at every eight weeks, there are still some people who are not completely dry because the drug probably isn't lasting the full eight weeks, even, and so you might see more drying as a manifestation of the longer So there are a couple of ways to slice, but surely you're looking to put more drugs on and have it last longer.

<unk> numbers of patients, who can do well with every 12 week dosing or every 16 week dosing. So that's the major goal of testing the higher dose.

Yeah Joe.

George is saying that you're trying to extend the actions, but if you look at an interval where in some patients let's say.

I'll take them in an every eight week interval theres still some people who are not completely dry because the drug probably isn't last thing the full eight weeks, even and so you might see more drawing is a manifestation of the long interaction. So the couple of ways to slice, but surely you you're looking to put more drug and have it last longer.

Operator: Please see the complete disclaimer at https://sites.google.com or at www.google.com.

Got it Super helpful. Thank you.

Yaron Berber: Next question, please.

Next question please.

Yaron Berber: The next question comes from Yaron Berber of Colvin. Your line is now open.

Your next question comes from Yaron Werber of Colin Your line is now open.

Marion McCourt: Great. Marion, maybe for you on asthma, can you give us a sense of what the share is now for DUPI and asthma, and we understand that from

Great Paul Marion maybe for you on as Mark can you give us a sense, what's the share now for <unk> in asthma.

We understand that some physicians per center has been very aggressive on pricing.

Marion McCourt: and we understand that from physicians, Placenta has been very aggressive on pricing. What can you do to...

What can you do to offset some of that growth et cetera. Thank you.

Marion McCourt: Sure, happy to take your question. But first, I'll say we're very pleased with the performance of Depixent, both in terms of initiations and total scripts. We haven't given details of share by indication, so I'll stay away from that specificity today. But as you can see from our total performance and the data shared, we certainly are performing very, very well in the asthma marketplace. I'm not going to comment on other companies' pricing strategies, but what I can say is when we look at the data comparing Depixent uptake, either initiations or total scripts, it compares very favorably to the IL-5s.

Sure happy to take your question first.

First I'll say, we're very pleased with the performance of <unk>. Both in terms of initiations and total scripts, we haven't given details of share by indication. So I'll stay away from that specificity today, but as you can see from our total performance and the you know the data shared we certainly are performing very very well in the asthma market play.

<unk>.

I'm not going to comment on other company's pricing strategies, but what I can say is when we look at the data comparing to pick some uptake either initiations of total scripts. It compares very favorably to the IL fives and we we know that this is a result of the <unk>.

Marion McCourt: And we know that this is a result of the clinical profile, the safety profile, and the value that not only pulmonologists but also allergists are seeing in Depixent for asthma, and as you know, with allergists, also treating patients with concomitant diseases.

The clinical profile, the safety profile and the value that not only pulmonologists, but also allergists are seeing <unk> for asthma and as you know with allergists also treating patients with concomitant diseases.

Operator: The next question comes from Kenan McKay of RBC Markets in Winesdale. Hi, thanks for taking that question.

Next question please.

Next question comes from Kevin Mcveigh of RBC Mark Your line is now open.

Kenny McKay: Hi, thanks for taking the question. One on Dupixent, maybe also for Marion. It seems like Dupixent is growing much faster in asthma than in AD, but it just seems like that's because Derm has such a larger sales basis. So, Marion, just wondering if you could tell me what percent of Dupixent's quarter over quarter growth is coming from asthma versus Derm. Thank you.

Hi, Thanks for taking the question one on the picture and maybe also for primary and it seems like <unk> is growing much faster in asthma benzene.

But it just seems like that becomes derm has such a larger sales basis. So Marion just wondering if you can frame what percent do pick things quarter over quarter growth is coming from Admob vs. Derm. Thank you.

Sure. So let me talk about the.

Total indications that that I can share with you is that the dermatology atopic dermatitis business <unk> is about 75%.

Kenny McKay: Indications that I can share with you is that the dermatology atopic dermatitis business in Dupixent is about 75 percent, about 25 percent in respiratory disease, both asthma and nasal polyps, asthma, of course, being the larger of the two in respiratory disease. Both are growing very, very strongly, and remember that we launched in atopic dermatitis several years before we did in the asthma marketplace. Both are growing very, very strongly, and certainly, as we look at the future potential for Dupixent in atopic dermatitis, we have a long way to go.

About 25% in respiratory disease, both asthma and nasal polyps asthma of course being the larger of the two and respiratory disease.

They are growing very very strongly and remember that we launched in atopic dermatitis. Several years before we did in the asthma marketplace.

Both are growing very very strongly and certainly as we look at the future potential for depicts in atopic dermatitis, we have a long way to go there's still tremendous unmet need across all age groups the youngest patients adolescents and adults and then the asthma market places, where it's important to note that today about.

Kenny McKay: There's still tremendous unmet need across all age groups, the youngest patients, adolescents, and adults, and then the asthma marketplace as well. You know it's important to note that today about 75 percent of the patients with asthma going on Dupixent are biologic naive, so we're getting these new starts. There's tremendous opportunity, and Dupixent has been one of the growers in the overall asthma biologics marketplace. As mentioned in the response to the earlier question, we look forward to, with FDA approval, the launch in pediatrics later this year, but among adults and adolescents, there's still tremendous opportunity for asthma as well.

75% of the patients in asthma going undertakes sent our biologic naive so were getting these new starts theres tremendous opportunity and depicts and has been one of the growers of the overall asthma biologics marketplace as mentioned in the in response to the earlier question, we look forward to.

With an FDA approval to launch in Pediatrics later, this year, but among adults and adolescence, there's still tremendous opportunity in asthma as well other growth engines for the product and this is without even the many indications I look forward to launching in the future related to type two disease like as soon as day like esophagitis since some of the other areas.

Kenny McKay: Both are growth engines for the product, and this is without even the many indications I look forward to launching in the future related to type 2 disease, you know, like synophilic esophagitis and some of the other areas and allergies that George mentioned in his update today.

Allergy that George mentioned in his update today.

Operator: Mary, we have time for two more questions. We're going to try to squeeze them in quickly.

Mary we have time for two more questions, we're going to try to squeeze them in quickly.

Sir next question comes from Brian Martin.

Brian Peter Skorney: Your next question comes from Brian Skorney of Beard. Your line is now open. Thank you for taking our question. This is Leah Lowe with LNN for Brian Skorney.

Eric Your line is now open.

Alright. Thank you for taking our question. This is probably a low dialing in for Brian Kearney. Our question is based on your partnership with Italia.

But we are anticipating a question people CRISPR data pretty soon and we've seen good success here with the ex vivo approach.

Maybe you can share your thoughts on the in vivo approach and how we should think about it in terms of looking at the safety of this approach not just for the <unk> indication for more broadly for the proof of concept for this day. Thank you.

George D. Yancopoulos: Yeah, I think that is the most important aspect of this for us, this is a platform, and as we said, we have multiple targets that might be amenable to this platform that we've already identified through our Regeneron Genetics Center. And so of great interest will be, does it work, and what will be its safety and tolerability profile? So, we think that this will be a platform determining some sort of result, depending on how it turns out.

George you want to take that yes, I think that is the most important aspect of this for US is this is a platform.

And as we said we have multiple targets that might be amenable to this platform that we've already identified through our Regeneron genetics center and so on.

Great interest will be does it work and.

What it will be the safety and the Tolerability profile. So we think that this will be a.

Platform.

Determining sort of.

Result, depending on how it turns out.

George D. Yancopoulos: Thanks, George. We have time for one more question.

Thanks, George we have time for one more question.

Operator: The next question comes from Carter Gould of Barclays. Your line is now open. Great.

The next question comes from Carter Gould of Barclays. Your line is now.

Carter Gould: Great. Congratulations on the quarter and thanks for all the progress in tackling COVID and for taking the question. As you think, how should we think about appropriate Regeneron COVID-2 production in an increasingly sort of post-vaccination world? And any insight into how countries and healthcare systems are approaching supplies and stockpiles? And I guess in answering that question, can you just clarify kind of where you and Roche stand in terms of capacity, the efficacy of lower doses, and continued improvements in efficiency and scale? Thank you.

Great congratulations on the quarter and thanks for all the progress in tackling covered and for taking the question.

If you think how should we think about how do you think about appropriate rich any COVID-19 to production and an increasingly sort of post vaccination world and any read into how countries that health care systems are approaching supply stock and stockpiling in I guess in answering that question can you just clarify kind of where are you in row stand in terms of capacity.

The efficacy at lower doses and continued improvements in efficiency and scale. Thank you.

Justin Helko: I don't think we're really in a position. It's better for Roche to comment on how the market is developing outside of the United States. But I do know that they're working on a lot of different discussions with a lot of different jurisdictions. And there is, as we speak now, an adequate supply, but obviously, the pandemic changes pretty quickly. So I think Roche is probably going to be better positioned to answer that question unless Justin has anything more specific.

Let me one day.

I don't think we're really in a position that's better for Roche to comment on how the market is developing outside of the United States.

But I do know that they're working on a lot of different discussions with a lot of different jurisdictions.

And.

There is.

As we speak now.

Adequate supply but.

Lee.

The pandemic changes pretty quickly so.

I think Roche is probably going to be better positioned to answer that.

Justin has anything more specific for you.

Justin Helko: Well, thank you to everyone who joined the call today. We still have several callers in the queue that we didn't get to. We apologize for that. We will follow up with you after the call. Thanks to everyone for dialing in. Be safe and have a good day.

Nope that's it.

Well. Thank you for everyone joining the call today, we still have several callers in the queue that we didn't get to we apologize for that we will follow up with you. After the call. Thanks to everyone for dialing in and be safe and have a good day.

Justin Helko: Thank you for your participation in today's conference call. This concludes the presentation. You may now disconnect. Good day.

Thank you for your participation in today's conference call. This concludes the presentation you may now disconnect good day.

Q1 2021 Regeneron Pharmaceuticals Inc Earnings Call

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