Q2 2020 Regeneron Pharmaceuticals Inc Earnings Call

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Ladies and gentlemen, thank you for standing by welcome to the Regeneron Pharmaceuticals, Q2 thousand 20 earnings Conference call.

Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Regeneron Pharmaceuticals Q2 2020 Earnings Conference Call. At this time, our participant lines are in a listen-only mode.

At this time all participant lines are in listen only mode.

After the speakers presentation.

Operator: After the speaker's presentation, we will have your questions and answers. To ask a question during this session, you will need to press star 1 on your telephone. Please be advised that today's call is being recorded. If you require any further assistance, please press star zero. Thank you, Justin Hoko.

The answer session.

To ask a question during the Kashi LICA Press star one on the telephone.

Please be advised today's call is being recorded.

Quite any further assistance. Please press star zero. Thank you Justin helpful. I'll now turn the call over to you.

Operator: I will now turn the call over to you. Thank you, Stephanie. 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 second quarter 2020 conference call. An archive of this webcast will be available on our website. Joining me today on the call are Dr. Leonard Schleifer, Founder, President, and Chief Executive Officer; Dr. George Yancopoulos, Co-Founder, President, and Chief Scientific Officer; Marion McCourt, Senior Vice President and Head of Commercial; and Bob Landry, Executive Vice President and Chief Financial Officer. 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 and its products and businesses, financial forecasts and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement issues, intellectual property, pending litigation and other proceedings, and competition. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in the state.

Thank you Stephanie good morning, good afternoon, and good evening, everyone listening around the globe. Thank you for your interest in Regeneron Pharmaceuticals, and welcome to the second quarter 2020 Conference call. An archive of this webcast will be available on our website.

Joining me today on the call are Dr., Leonard Schleifer, founder President and Chief Executive Officer, Dr., George Yancopoulos Co founder President and Chief Scientific officer marrying the courts Senior Vice President head of commercial and Bob Landry Executive Vice President and Chief Financial Officer. After our prepared remarks, we'll open the call for today I would also.

To remind you that remarks made on todays call include forward looking statements about regeneron such statements may include but are not limited to those related to regional jet or on.

And its products and businesses financial forecast and guidance development programs and related anticipated milestones collaborations finances regulatory matters payer coverage of 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 and statement.

Operator: A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarterly period ended June 30, 2020, which was filed with the SEC today. Regeneron does not undertake any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. In addition, please note that GAAP and non-GAAP measures will be discussed in today's call. Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available in our financial results press release, which can be accessed on our website.

A more complete description of these and other material risks can be found a regenerons filings with the United States Securities and Exchange Commission, including its form 10-Q, four the quarterly period ended June Thirtyth 2020, which has been filed with the FCC 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 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 on the IR team will be available to answer for the questions with that let me turn the call over to our President and Chief Executive Officer, Dr. lunch flavor.

Operator: 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. Thank you, Justin.

Thank you Justin Thanks to everyone for joining the call.

Leonard S. Schleifer: And thanks to everyone for joining the call. I hope all of you are staying safe and well. We very much appreciate your efforts to join given the pandemic conditions and, on top of that, in the Northeast, some power disruption from the storm. But business continues.

All of you are staying safe and well.

We very much appreciate your efforts to join given the pandemic conditions and even on top of that northeast some power disruption from the storm.

But business continues we had an event for unproductive second quarter in terms of financial results business development and corporate accomplishments in the second quarter results demonstrated resilience and strength.

Leonard S. Schleifer: We had an eventful and productive second quarter in terms of financial results, business development, and corporate accomplishments. In the second quarter, our results demonstrated resilience and strength despite the impact of the ongoing COVID-19 pandemic. In addition to driving double-digit top and bottom line growth, we will continue to deliver meaningful advances in our broad and innovative pipeline, as well as in our fight against COVID-19 with our novel antibody cotton. Regeneron continues to execute well in this unprecedented time for our company, our nation, and the world. Starting with our product. ILEA global net product sales were $1.75 billion in the second quarter, a modest decline of 6% compared to the prior year.

Despite the impact of the ongoing cobot 19 pandemic.

In addition to driving double digit top and bottom line growth, we continue to deliver meaningful advances in our broad and innovative pipeline as well as enough fight against covert 19, with our novel antibody cocktail Regeneron continues to execute well in this unprecedented time for our company.

Our nation in the World.

Starting with our products I leave that global net product sales were $1.75 billion in the second quarter, a modest decline of 6% compared to the prior year.

In the U.S., we generated sales of 1.11 billion with a pronounced and sustained rebound in demand in May and June following the decline in sales we experienced in early April.

Leonard S. Schleifer: In the U.S., we generated sales of $1.11 billion. With a pronounced and sustained rebound in demand in May and June following the decline in sales we experienced early this year, this rebound has continued into July, and demand is now approaching pre-COVID levels. The efficacy, safety, and convenience of ILEA have proven to be even more viable in the world of COVID-19. And as you'll hear from Marion, Aliyah outperformed the broader anti-VEGF class this quarter. Demand for Dubixin also proved to be robust in the second quarter, with global sales growth of 70% compared to last year. Sales were nearly $1 billion on continued market penetration in atopic dermatitis, asthma, and new lung diseases. Adding to the dupixent...

This rebound has continued into July into July and demand is now approaching pre covert levels.

The efficacy safety and convenience of I Leah have proven to be even more valuable in the world of Cobot 19, as you'll hear from Marianne I leave outperformed the broader anti VEGF class this quarter to.

Demand for Dupixent also proved to be robust in the second quarter with global sales growth of 70% compared to last year sales when nearly $1 billion on continued market penetration in eight topic dermatitis asthma and new launches.

Adding to the Dupixent momentum the F.D.A. approved a new indication for eight topic dermatitis in children, aged six to 11.

Furthermore, we demonstrated dramatic results and eosinophilic esophagitis, where patients reported in nearly 70% reduction in symptoms.

Leonard S. Schleifer: The FDA approved a new indication for atopic dermatitis in children aged 6 to 11. Furthermore, we demonstrated dramatic results in eosinophilic esophagitis, where patients reported a nearly 70% reduction in symptoms, further exemplifying the potential of DuPix. To bend the arc, a certain type 2... We look forward to additional Dupixent miles, including an upcoming phase 3 readout in Pediatric Asthma and enrollment of a second phase 3 study in chronic obstructive pulmonary In oncology, libtile is the leading systemic treatment. Taney Esquimus, Al Carcino, We are seeking approvals in basal cell carcinoma and non-small cell lung cancer, with regulatory filings to be. With our chemotherapy combination study in non-small cell lung cancer nearing full enrollment, our excitement for Libtio continues to grow.

Other exemplifying the potential of Dupixent to bend the arc certain type two inflammatory diseases, we look forward to additional dupixent milestones, including an upcoming phase three read out in pediatric asthma and enrollment of a second phase three study in chronic obstructive pulmonary disease, we you know a patient.

And customers have a tremendous amount of enthusiasm for this product and we are still in the early days of unlocking its full potential with a partner Sanofi.

In oncology lived tile is the leading systemic treatment for cutaneous squamous cell carcinoma, we are seeking approvals and basal cell carcinoma, and non small cell lung cancer with regulatorily for regulatory filings to be submitted imminently.

Without chemotherapy combination study in non small cell lung cancer nearing full enrollment our excitement for live tyo continues to grow.

Beyond that tie it we are broadening advancing our bi specifics portfolio generating further momentum for our oncology strategy.

Turning to our efforts to fight Cobot 19, we are advancing the development of a novel antibody cocktail known as our E G and she'll be too that made both treat and prevent infection from the Sars coke to virus.

Leonard S. Schleifer: Beyond Liptaya, we are broadening and advancing our biospecifics portfolio, generating further momentum for our oncology strategy. Now, turning to our efforts to fight COVID-19. We are advancing the development of a novel antibody cocktail known as REGN-CoV-2 that may both treat and prevent infection from the SARS-CoV-2 virus. We are now in Phase 2 and Phase 3 trials and hope to generate initial data by the end of September, as George will discuss in further detail. We have also signed two major agreements in recent weeks.

We are now in phase two and phase three trials and hope to generate initial data by the end of September as George will discuss in further detail.

We also signed two major agreements in recent weeks, we announced a $450 million agreement with BARDA and the U.S. Department of defense to manufacture, our EG and Coke too.

We also signed a six year 345 million dollar agreement with BARDA for our novel Ebola antibody cocktail further demonstrating the potential of our end to end technologies to deliver shareholder value in addressing infectious disease threats.

Finally on the corporate front, we contemplate excuse me, we completed a large secondary offering.

Leonard S. Schleifer: We announced a $450 million agreement with BARDA and the U.S. Department of Defense to manufacture REGN-CoV-2. We also signed a six-year, $345 million agreement with BARDA for our novel Ebola antibody cox, further demonstrating the potential of our end-to-end technology to deliver shareholder value. Addressing Infectious Disease Threats Finally, on the corp. Contemplate, we have completed a large secondary... of more than 13 million shares of our common stock held by Sanofi. Using our strong balance sheet, we also repurchased $5 billion on 9.8 million shares.

More than 13 million shares of common stock held by Sanofi.

Using our strong balance sheet, we also repurchased $5 billion on 9.8 million shares from Santa fee effectively eliminating the ownership position in our company and demonstrating our confidence in the trajectory of our business.

For Regeneron shareholders. This transaction provided immediate accretion and removed a significant overhang related to the expiration of Santa fees lockup period at the end of this year.

Regeneron as a business that is indeed firing on all cylinders. We thank all of our colleagues across the company who have been working with resolve and resilience in these extraordinary times.

Leonard S. Schleifer: Effectively eliminating their ownership position in our company and Demonstrating Our Common Value For Regeneron shareholders, this transaction provided immediate accretion and removed a significant overhang related to the expiration of Santa Fe's lock-up period at the extraordinary times of the pandemic. I want to thank all of our colleagues across the board, who have been working with Resolve and Resilient during these extraordinary times of the pandemic. Cash Flow, Balance, Weather Co., and emerged from the pandemic to drive a continued long, Now I'll turn the call over to you, Lyon.

Of the pandemic.

Our strong business performance cash flow balance sheet and advancement of the next generation of innovations for important medical needs has us positioned to weather covert 19 and emerge from the pandemic to drive continued long term growth now I'll turn the call over to George.

Thank you land.

And with all of its still in the throws of the covert 19 epidemic I will start with an update on our anti viral antibody cocktail that has the potential to both possibly protect against infection and also treat those already infected.

George D. Yancopoulos: And with all of us still in the throes of the COVID-19 epidemic, I will start with an update on our antiviral antibody cocktail that has the potential to both possibly protect against infection and also treat those already infected. Based on our ball program, our new non-humate primate data for our COVID-19 cocktail, as well as our understanding of the immune response. We believe that our COVID-19 treatment is well-positioned to help patients prior to and early in infection. We initiated our clinical program in June, barely five months after we started this treatment. Developing this treatment. Our rapid timeline was possible due to our VelociSuite technologies, which were developed in-house over decades to allow for specific turnkey disease interventions and were recently applied to develop our similar approach against Ebola, which we hope will prove to be the first treatment approved for this disease with a PDUFA date in October.

Based on our Boulder program.

Our new non human primate data for Ur Cobot, 19 cocktail as well as our understanding is immune response, we believed that our covert 19 treatment is well positioned to help patients prior to and early and infection. We initiated our clinical program in June nearly five months. After we started this stuff.

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A rapid timeline was possible due to a lots of suite technologies, which were developed in house over decades to allow for specific turnkey disease interventions and were recently applied to develop our similar approach against a bowl, which we hope will prove to be the first treatment approved for this disease with the PDUFA date in October.

We're currently conducting four trials regeneron comp to our antibody cocktail one in hospitalized covert 19 patients a second ambulatory studying how patients who are diagnosed with over 19, a third preventative studying household contacts have coburn 19 patients being carried out in collaboration.

George D. Yancopoulos: We are currently conducting four trials of Regeneron-CoV-2, our antibody cocktail, one in hospitalized COVID-19 patients. A second, ambulatory study in outpatients who are diagnosed with COVID-19. A third, preventative study in household contacts of COVID-19 patients being carried out in collaboration with the National Institute of Allergy and Infectious Diseases, and a fourth, multi-dose healthy volunteer study. Our studies are adaptive in nature, as we learn more about the virus in our antibody cocktail, and other studies are being planned as well. All of these studies have passed several safety assessments with no safety concerns observed to date.

With the National Institute of allergy and infectious disease.

In a for multi dose healthy volunteer study.

Oh studies are adaptive in nature as we learn more about the virus in or antibody cocktail in other studies are being planned as well.

All of these studies have passed several safety assessments with no safety concerns observed to date.

Despite the challenging environment in which these days are being conducted we are targeting a reporter initial virology and biomarker data from the treatment studies by the end of September with clinical outcome data to follow as enrollment progresses.

In June we published two important papers in science honoree antibody cocktail in which we describe the details of how the two antibodies you don't cocktail block the Corona virus spike protein and importantly.

The significance of using an antibody cocktail versus a single antibody approach.

We showed that the cocktail approach avoided viral escape due to viral mutation.

George D. Yancopoulos: Despite the challenging environment in which these studies are being conducted, we are targeting to report initial virology and biomarker data from the treatment studies by the end of September, with clinical outcome data to follow as enrollment progresses. In June, we published two important papers in Science on our antibody cocktail, in which we describe the details of how the two antibodies in our cocktail block the coronavirus spike protein and, importantly, highlighted the significance of using an antibody cocktail versus a single antibody approach. We showed that the cocktail approach avoided viral escape due to viral mutation, which rapidly occurs when using single antibody approaches. In addition, we have recently generated important data on non-human primates, which has been posted on bioRxiv.

Which rapidly occurred when using single antibody approaches.

In addition, we have recently generate important data in non human primates, which has been boat posted on bio archives.

These studies showed that in this setting or anybody cocktail can not only effectively prevent infection primates matching or exceeding recently published prevention data achieved with vaccine approaches, but also that our cocktail can treat those already infected by accelerating but elimination.

An excellent a highlight the outside support we have received for our strategy. In addition to conducting our phase three prevention study in collaboration with the Eni I'd, which subsequently expands our reach to investigate our cocktail in the preventative setting we recently signed a manufacturing contract with BARDA as part of.

Operation Warp speed to make initial lots of our cocktail at risk. So the drug could be available as soon as possible it proven efficacious and approved by the FDA.

George D. Yancopoulos: These studies showed that in this setting, our antibody cocktail can not only effectively prevent infection in primates, matching or exceeding recently published prevention data achieved with vaccine approaches, but also that our cocktail can treat those already infected by accelerating viral elimination. I next want to highlight the outside support we have received for our strategy. In addition to conducting our Phase 3 prevention study in collaboration with the NIAID, which substantively expands our reach to investigate our cocktail in the preventative setting, we recently signed a manufacturing contract with BARDA as part of Operation Warp Speed to make initial lots of our cocktail at risk so that the drug could be available as soon as possible. We are all hoping that vaccines prove successful.

Well, we're all hoping that vaccines proved successful we ourselves are partnering on some novel second generation vaccine approaches.

We believe that our neutralizing antibody cocktail could play an important role as a rapid first line in defense in dose for whom of vaccine is not available.

And in the long term could also provide protection for those lease likely to respond well to a vaccine such as the elderly and immunocompromised mice.

Moreover, unlike the vaccine and that's supported by our initial Primate studies are cocktail may not only prevent infection, but could also have the potential treat those already infected.

Moving onto our efforts outside of cobot, 19th and starting with the picks up.

Demonstrated safety and efficacy of Dupixent or further bolstered by the recent FDA approval in children with moderate to severe atopic dermatitis.

Children as young as six years old and we're not stopping there as we are conducting the study even younger eight topic dermatitis patients and for chosen with asthma, we plan to submit a BLE supplement for approval in pediatric as one by the end of the year pending upcoming phase three data.

George D. Yancopoulos: And we ourselves are partnering on some novel second-generation vaccine approaches. We believe that our neutralizing antibody cocktail could play an important role as a rapid first line of defense in those for whom a vaccine is not available and, in the long term, could also provide protection for those least likely to respond well to a vaccine, such as the elderly and immunocompromised.

We're also enhancing convenience for all patients with the recent FDA approval of our 300 milligram auto injector.

Outside of the United States to fix it was approved in China recently, which represents a major milestones we work to ensure patients everywhere have access to this life changing medicine.

Our Dupixent clinical program continues to deliver positive results in additional type two inflammatory indications in May we announced that we met the primary in key secondary endpoints in part a of our pivotal trial in eosinophilic esophagitis.

George D. Yancopoulos: Moreover, unlike a vaccine, and as supported by our initial primate studies, our cocktail may not only prevent infection but could also have the potential to treat those already infected. Moving on to our efforts outside of COVID-19 and starting with to pick, the demonstrated safety and efficacy of Dupixen are further bolstered by the recent FDA approval in children with moderate to severe atopic dermatitis, including children as young as 60 years

Patients treated with Dupixent demonstrated significant clinical and in atomic improvements with almost a 70% reduction in disease symptoms compared to an approximately 30% reduction for patients on placebo as demonstrated by the Dysphasia symptom question Yeah.

We are currently enrolling part B of this trail and communicating with regulators about filing requirements for the syndication.

In addition, the first pivotal dupixent trial in patients with chronic obstructive pulmonary disease typified by type two inflammation or type to see LPD completed a pre specified analysis by the independent data monitoring committee, requiring a certain threshold reduction in exacerbations, which was.

George D. Yancopoulos: And we are not stopping there, as we are conducting a study in even younger atopic dermatitis patients. And for children with asthma, we plan to submit a BLA supplement for approval in pediatric asthma by the end of the year, pending upcoming phase 3 data. We're also enhancing convenience for all patients with the recent FDA approval of our 300 milligram auto-injector. Outside of the United States, Dubixin was approved in China recently, which represents a major milestone as we work to ensure patients everywhere have access to this life-changing medicine.

Matt and thus triggered opening a second pivotal trial for this potential indication.

[noise] approval in type two CRPD would unlock another important opportunity for dupixent to help patients with type two inflammatory disease, who currently have limited options.

Moving onto our oncology portfolio and starting with our PD one antibody lipton, while at the virtual ASCO meeting, we presented a clinical clinically meaningful cutaneous squamous cell carcinoma data follow up.

Followed by a label update as well as reported ask Bill was up to three years, a follow up while the overall response rates remain stable approaching 50%. The complete response rates have climbed to 20% in metastatic see FCC, increasing from the 7% rate reported.

George D. Yancopoulos: Our DUPIXEN clinical program continues to deliver positive results in additional type 2 inflammatory indications. In May, we announced that we met the primary and key secondary endpoints in Part A of our pivotal trial in eosinophilic esophagitis. Patients treated with dupixent demonstrated significant clinical and anatomic improvements with almost a 70% reduction in disease symptoms compared to an approximate 30% reduction for patients on placebo, as demonstrated by the dysphagia symptom questionnaire. We are currently enrolling Part B of this trial and communicating with regulators about filing requirements for this indication. In addition, the first pivotal depiction trial in patients with chronic obstructive pulmonary disease typified by type 2 inflammation, or type 2 COPD, completed a pre-specified analysis by the Independent Data Monitoring Committee requiring a certain threshold reduction in exacerbations, which was met, and thus triggered the opening of a second pivotal trial for this potential indication.

The initial primary announces providing one of the most dramatic examples of ongoing in prolong benefit from an immunotherapy treatment.

Moreover, these data firmly established reptile.

As first in class for this dermatology cancer setting with compelling long term clinical data.

In addition last quarter, we announced positive first in class data for a second German tell in college indication that is basal cell carcinoma, which we will be submitting for regulatory review.

Finally, we're excited about the opportunity for the tile in non small cell lung cancer based on our recent positive phase three trial with lip tile as monotherapy in PDL one high patient.

Which will also be submitting for regulatory review and we have completed screening patients for enrollments in our follow on chemo combination study in lung cancer.

Taos foundational to oncology strategy, and we're making significant progress with will chime in skin cancers lung cancers in are numerous combination and collaborative studies.

Our cdthree by specific clinical program is moving forward despite operational challenges imposed by the covert 19 pandemic Regeneron 1979, or cdtwenty by Cdthree bi specifics I showed robust efficacy in both the LQA lymphoma, and more aggressive disease, including diffuse large.

B cell lymphoma or.

Or potentially pivotal phase two study continues to enroll globally and we are having productive discussions with regulators to expand the registrational program with combinations in earlier lines of team.

George D. Yancopoulos: Approval in type 2 COPD would unlock another important opportunity for depiction to help patients with type 2 inflammatory disease who currently have limited options. Moving on to our oncology portfolio, and starting with our PD-1 antibody, Liptio. At the virtual ASCO meeting, we presented clinically meaningful cutaneous squamous cell carcinoma data follow-up, followed by a label update as well. As reported at ASCO, with up to three years of follow-up, while the overall response rates remain stable, approaching 50%, the complete response rates have climbed to 20% in metastatic CFCC, increasing from the 7% rate reported in the initial primary analysis, providing one of the most dramatic examples of ongoing Moreover, these data firmly establish Leptile.

We are preparing to explore novel combinations, including a combination.

From a novel class of coast inventory by specifics that is one targeting b cell specifically, we recently published a second major Paypal featured on the cover of Science translational Medicine in June describing how these coast inventory bison suffix can synergize not only will see three by specifics, but also with.

PD one blockers.

Finally, we are actively working on subcutaneous delivery this potentially important drug candidate.

Bcm aimed by Cdthree by specific is moving forward and we're planning to initiate potentially pivotal studies in various multiple myeloma sentence. Moreover, we intend to explore standard novel combinations, including with the co stimulatory Biospecific.

Targeting.

Yes and cells.

We expect to provide updates for both us Cdtwenty NBC programs at Ash later this year.

I would like to expand a bit on or co stimulatory by specific effort as it represents an important example, the ongoing innovation in oncology for Regeneron as I said, we're planning on combining such coast ins with both our Cdtwenty in bcm, a by spec programs for lymphoma in myeloma, but our first coast inventory.

George D. Yancopoulos: We are the first in class for this dermato-oncology cancer setting with compelling long-term clinical data. In addition, last quarter, we announced positive first-in-class data for a second dermato-oncology indication, that is, basal cell carcinoma, which we will be submitting for regulatory review. Finally, we're excited about the opportunity for Leptio in non-small cell lung cancer based on our recent positive phase 3 trial with Leptio as monotherapy in PD-L1 high patients, which we will also be submitting for regulatory review. And we have completed screening patients for enrollment in our follow-on chemo combination study in lung cancer. Leptio is foundational to our oncology strategy, and we are making significant progress with Leptio in skin cancers, lung cancers, and our numerous combination and collaborative studies. Additionally, our CD3 bispecifics clinical program is moving forward, despite operational challenges imposed by the COVID-19 pandemic. Regeneron 1979, our CD20 by CD3 bispecific antibody, has shown robust activity in both follicular lymphoma and more aggressive diseases, including diffuse large B cell lymphoma.

By specific is already in clinical development.

First in humans coasting Pmeight by C. D's 28 is in combination with lead times for prostate cancer and its continuing to enroll in the dose escalation stage of clinical investigation.

We're also excited about two additional coast in bi specifics scheduled to enter the clinic this year.

These new coast in trials include F. R. By CD 28 in combination with tile, which will be explored and several solid tumors.

Including lung cancer, and head and neck cancer as well as much 16 by CD 28, which will be tested for patients with ovarian cancer as well as in other settings or months 16 coast and will be study in combination with either lip tire or months 16 by C by specific which is already in the clinic.

The span of our tool kit enables us to explore these and many new combinations that based on preclinical evidence could provide meaningful advances for a wide variety of cancer patients.

Moving on from oncology I would like to provide an update on our facility mere program.

We previously announced positive top line efficacy data in a city ma'am phase III fact long term safety study or fact, LTL sub study and today, we're announcing that two additional phase three studies in patients with osteoarthritis pain.

George D. Yancopoulos: Our potentially pivotal Phase II study continues to enroll globally, and we are having productive discussions with regulators to expand the registrational program with combinations and in earlier lines of treatment. We are preparing to explore novel combinations, including a combination from our novel class of co-stimulatory bispecifics that is one targeting B-cells specifically. We recently published a second major paper featured on the cover of Science Translational Medicine in June, describing how these co-stimulatory bispecifics can synergize not only with CD3 bispecifics but also with PD-1 blockers. Finally, we are actively working on subcutaneous delivery of this potentially important drug candidate. Our BCMA by C3 bi-specific is moving forward, and we are planning to initiate potentially pivotal studies in various multiple myeloma settings. Moreover, we intend to explore standard and novel combinations, including with co-stimulatory bi-specific targeting. Plasmas

Backed away one in fact, a way to met the co primary efficacy endpoint for the Simeon one milligram monthly dose versus placebo.

The physician you may have one milligram monthly dose also showed nominally significant benefits in physical function in both trials in pain in one of the two trials when compare to the maximum SD eight approved doses of end sets for osteoarthritis the less frequent dosing of the seem to have one milligram every two.

In months used in an arm of the fact away one trial showed numerical benefit over placebo, but did not achieved statistical significance.

In initial safety analysis from in Phase three trials, there was an increase Northrop feeds reported with Sydney, Matt in the fact LTL sub study there was an increase in joint replacements with rescinding. They have one milligram monthly treatment during the off drug follow a period. Although this increase was not seen in the other trials to date.

Additional longer term safety data from the ongoing trials is being collected and is expected to be reported early next year.

Finally, I would like to briefly address other exciting developments in our pipeline.

George D. Yancopoulos: We expect to provide updates for both our CD20 and BCNA programs at ASH later this year. I would like to expand a bit on our co-stimulatory bispecific effort, as it represents an important example of the ongoing innovation in oncology for Regeneron. As I said, we are planning on combining such co-stims with both our CD20 and BCMA bispec programs for lymphoma and myeloma. But our first co-stimulatory bispecific is already in clinical development. This first-in-humans co-stim, PSMA by CD28, is in combination with liptia for prostate cancer and is continuing to enroll in the dose escalation stage of clinical investigation.

We are planning to publish of enacting map result in homozygous familial hypercholesterolemia shortly and we have submitted our applications to the FDA and EMA.

Regarding our Gary touched on the program for fibrils dysplasia, Ossificans Progressiva or FOP, we're planning to submit data to regulatory authorities in the first quarter next year pending results from the crossover arm of our trial were placebo patients are now receiving active drug our hope is to replicate.

The dramatic 90% reduction in new lesion formation that we store in the first part of the trial.

The European Hematology Association meeting in June we presented promising Brazil amid monotherapy interim results in Paris, ASML nocturnal Hema to global urea patients.

George D. Yancopoulos: We're also excited about two additional Coast and Bi-Pacifics scheduled to enter the clinic this year. These new CoSTIM trials include EGFR by CD28 in combination with the TIA, which will be explored in several solid tumors, including lung cancer and head and neck cancer, as well as MUX16 by CD28, which will be tested for patients with ovarian cancer as well as in other settings. Our MUX16 co-stim will be studied in combination with either Leptile or our MUX16 by CD3 bispecific, which is already in the clinic.

We are hoping to start testing in combination with El Nio homes, Arnie I treatment Sun discerning.

By year end.

And last but certainly not least we're starting to enroll or phase three studies of high dose I Leah in DMD and wedding MD.

I'd also like it has the potential to reduce dosing frequency, while maintaining the efficacy and safety of our Madison that is trusted by doctors and patients worldwide.

To conclude.

Broad and diverse pipeline is growing and progressing even in this covert 19 environment.

I would not be parameter that even in these extraordinary in challenging times. Our people are continuing to push on every front in our efforts to bring import new treatments to the patients who need.

I now turn over the call to Marriott.

Thank you during our second quarter business performance reflects the resilience and competitive strength of our programs.

George D. Yancopoulos: The span of our toolkit enables us to explore these and many new combinations that, based on preclinical evidence, could provide meaningful advances for a wide variety of cancer patients. Moving on from oncology, I would like to provide an update on our Facinimab program. We have previously announced positive top-line efficacy data in a Ficiniumab Phase III FACT long-term safety study, or FACT LTS sub-study, and today we are announcing that two additional Phase III studies in patients with osteoarthritis pain, FACT OA1 and FACT OA2, met the co-primary efficacy endpoints for the Ficiniumab one milligram monthly dose versus The faciniumab 1 mg monthly dose also showed nominally significant benefits in physical function in both trials and pain in one of the two trials when compared to the maximum FDA-approved doses of NSAIDs for osteoarthritis.

Okay.

We remain confident.

Navigate through 17 and position our portfolio for future growth loan recoveries.

I'm going to begin with idea, which help 1.75 below global net sales in the U.S. only in net sales were 1.11 billion, because just 4% slower than same quarter last year. Despite the impact of Kevin 19.

Outperformed the overall entomologist marketing with continued share gains from both branded and unbranded competition.

Yes, I lose share of the branded U.S. market means 73%.

Net sales for the quarter solidifying our leadership position in the intervention market.

The impact just because of 19 on unit sales of sub predominantly April after those sales improved.

On into Q as retina specialists, we opened offices inpatient volume increased the combination of three.

Attributes differentiated efficacy safety and dosing flexibility are highly valuable easing physician and patient gardens caused by the pandemic physicians need treat with extended dosing of up to 12 weeks and appropriate patients and recently launched pre filled syringe offers additional effect.

George D. Yancopoulos: The less frequent dose of faciniumab 1 mg every two months used in an arm of the FACTO A1 trial showed a numerical benefit over placebo but did not achieve statistical significance. In initial safety analysis from the Phase 3 trials, there was an increase in arthropathies reported with viciniumab. In the FACT-LTS sub-study, there was an increase in joint replacements with viciniumab 1 mg monthly treatment during the off-drug follow-up period, although this increase was not seen in the other trials to date. Additional longer-term safety data from the ongoing trials is being collected and is expected to be reported early next year. Finally, I would like to briefly address other exciting developments in our pipeline. We are planning to publish a venacumab result in homozygous familial hypercholesterolemia shortly, and we have submitted our applications to the FDA and to EMA.

He's for patient care.

Elliott demand continues to show steady improvement and the volume of new patients in the market is approaching pre pandemic levels. We're closely monitoring the recent resurgence of covered 19 under all scenarios. We remain highly committed just putting retina community to virtual and in person platforms to ensuring the cost.

Finally, a patient care in summary, we are encouraged by the rebound and idea demand in recent months and we will continue to advance efforts to support our customers and their patients during these unprecedented times.

Turning next to let tile second quarter Global net sales grew to 80 million with the U.S. contributing 63 million in April patient office visits decline insemination centers temporarily closed just briefly impacted on the tire demand, which we now we bounded during may and June in.

George D. Yancopoulos: Regarding our GERITUSIMA program for Fibromyalgia Ospicans Progressiva, or FOP, we are planning to submit data to regulatory authorities in the first quarter of next year, pending results from the crossover arm of our trial, where placebo patients are now receiving active drugs. Our hope is to replicate the dramatic 90% reduction in new lesion formation that we saw in the first part of the trial. At the European Hematology Association meeting in June, we presented promising pozzolimab monotherapy interim results in paroxysmal nocturnal hematoglobinuria patients.

Do you estimate tile advanced its leadership as the number one systemic treatment for advanced cutaneous squamous cell carcinoma Rcs cc.

Talented experienced rapid growth in advance CCC with 70% patients now treated with anti PD one therapy, we expect teacher class excellent tile as deemed the tire competitive profile strengthens with new long term data demonstrating longer durability higher overall responses and near.

George D. Yancopoulos: We are hoping to start testing a combination with alnilam's RNA eye treatment, some disirine, by year end. And last but certainly not least, we are starting to enroll our Phase III studies of high-dose ILEA in DME and wet AMD. High-dose ILEA has the potential to reduce dosing frequency while maintaining the efficacy and safety of our medicine that is trusted by doctors and patients worldwide.

At least three times the weight of complete responses.

On additional years a follow up.

Looking ahead, we are preparing for potential future launches with our collaborators sanity in both non small cell lung cancer and basal cell carcinoma, both represent meaningful growth opportunities from the tail.

Marion McCourt: To conclude, our broad and diverse pipeline is growing and progressing, even in this COVID-19 environment. I could not be prouder that even in these extraordinary and challenging times, our people are continuing to push on every front in our efforts to bring important new treatments to the patients who need them. I now turn over the call to Marion. Thank you, George. Our second quarter business performance reflects the resilience and competitive strength of our corporate, Aaliyah Dupickson, and LeBaron.

Anti PD one PDL one market continues to grow at a significant piece with current annual net sales of nearly 25 billion non small cell lung cancers, the largest opportunity within this market with more than 200000, new diagnoses of lung cancer in us each year patients payers and physician.

Preferred choice in determining the most appropriate treatment and should live tile be approved it has demonstrated very competitive clinical results to date and the advanced PD one positive patient population studied.

Finally, moving to Texan level net sales in the second quarter, or 945 million, representing 70% growth compared to prior year in the U.S. broad based growth across all approved indications contributed net sales of 770 million. Following an initial debt in may.

Marion McCourt: We remain confident in our ability to navigate through COVID-19 and position our portfolio for future growth in demand. I'm going to begin with ILEA, which had $1.75 billion in global net sales. In the U.S., ILEA net sales were $1.11 billion, which is just 4% slower than the same quarter last year, despite the impact of COVID-19. Aliyah outperformed the overall anti-VEGF market in the U.S. with continued share gains from both branded and unbranded. In fact, I lead a share of the branded U.S. market The Bulletproof Executive 2013, The impact of COVI After this, sales improved throughout May and into June as retina specialists reopened offices, and patient volume increased.

May new patient starts have increased as physician offices reopened.

Current weekly new patient starts have recovered to approximately 87% of pre pandemic levels a sign of robust demand for dupixent to take since Q compelling clinical profile enables the product to thrive even in the current environment. It takes and is administered at home and does not require laboratory testing or more.

Monitoring to initiate most new patients.

Importantly, dupixent is not an immuno suppressant and we expect the U.S. launch of the 300 milligram presale 10 in the third quarter, providing additional patient convenience and choice.

Atopic dermatitis, Huston, Texas largest indication and remains a significant growth driver, we continue to expand physician prescribing across both moderate and severe disease today only a small percentage of biologic eligible patients have been treated leaving substantial opportunity for more patients to benefit.

Marion McCourt: The combination of three ILEA attributes, differentiated efficacy, safety, and dosing flexibility, is highly valuable in easing physician and patient burdens caused by the pandemic. Physicians may treat with extended dosing of up to 12 weeks in appropriate patients, and the recently launched pre-filled syringe offers additional efficiencies for patient care. ILEA demand continues to show steady improvement, and the volume of new patients in the market is approaching pre-pandemic levels. We're closely monitoring the recent resurgence of COVID-19. Under all scenarios, we remain highly committed to supporting the retina community through virtual and in-person platforms to ensure the continuity of patient care. In summary, we're encouraged by the rebound and ILEA demand in recent months, and we will continue to advance efforts to support our customers and their patients during these unprecedented times. Turning next to Libtio, second quarter global net sales grew to $80 million, with the U.S. contributing $63 million. However, in April, patient office visits declined, and some infusion centers temporarily closed.

Additionally, new long term data demonstrate sustained efficacy over a three year period, along with confirm safety. We also continue to expand into younger populations USSTC recently print to take some to exceed 76 to 11 years with moderate to severe atopic dermatitis, which impacts approximately.

90000 children in this country depicts as the only biologic medicines to patients in this population and leading launch indicators are very encouraging many children suffering with moderate to severe atopic dermatitis are being treated by the senior positions, who has extensive clinical experience with our adolescence and adult.

Basins and have great confidence in the depicts and safety profile. It takes it also continues to outperform in asthma as measured by more new patient initiations over the last year compared to other biologic competitors, we see further opportunities to expand patient awareness of Dupixent in.

A national DTC campaign, which is underway.

Among those already on treatment Covance 19 has limited impact as patients here to their therapies to maintain and improve respiratory function.

Marion McCourt: This briefly impacted Libtio demand, which rebounded during May and June. In the U.S., Libtio advanced its leadership as the number one systemic treatment for advanced cutaneous squamous cell carcinoma, or CSCC. Libtio has experienced rapid growth in advanced CSCC, with 70% of patients now treated with anti-PD-1 therapy. We expect future growth as Libtio's competitive profile strengthens, with new long-term data demonstrating longer durability, higher overall responses, and nearly three times the rate of complete responses based on additional years of follow-up. Looking ahead, we are preparing for potential future launches with our collaborator Sanofi in both non-small cell lung cancer and basal cell carcinoma. Both represent meaningful growth opportunities for Libkio.

Finally, we see strong uptake in chronic rhinosinusitis with nasal polyps since approval last year patients have been initiated on topics that regardless of prior surgery demand has increased among NTS analogist with the limited availability of elective surgeries in the last quarter.

Overall, we see great opportunity for to Texas, which is positioned for significant growth through expanded indications age groups and geographies in closing our teams and business remain resilient as we execute on our strategy to deliver value for customers and stakeholders now ill turn the call to Bob.

Thank you Marion.

For the second quarter of 2020, Regeneron delivered strong results on both the top and bottom line or continued ability to generate this year over year growth is an encouraging signal, although our diversified growth potential now is beyond coded 19 for the second quarter total revenues grew 24% year over year to.

Marion McCourt: The anti-PD-1 and PD-L1 market continues to grow at a significant pace with current annual med sales of nearly $25 billion. Non-small cell lung cancer is the largest opportunity within this market, with more than 200,000 new diagnoses of lung cancer in the U.S. each year. Patients, payers, and physicians prefer choice in determining the most appropriate treatment, and should Liptio be approved, it has demonstrated very competitive clinical results to date in the advanced PD-1 positive patient population study. Finally, moving to DEPIXENT, global net sales in the second quarter were $945 million, representing 70% growth compared to the prior year. In the U.S., broad-based growth across all approved indications contributed net sales of $770 million. Following an initial dip in mid-May, new patient starts have increased as physician offices reopened.

1.95 billion driven by higher Sanofi collaboration revenues as a result of increasing Dupixent sales. Additionally, we recorded significant revenues associated with our infectious disease efforts against both biller encoded 19, these revenues or recorded in our other revenue line.

Non-GAAP diluted net income per share grew 19% year over year to $7 in 16 cents.

Non-GAAP net income of 854 million.

Since marine discuss the USA Leo results I will start with our Bayer incentive fee collaborations.

Starting with the Bayer collaboration ex U.S silent net product sales, which are reported to us by Bayer were 641 million, representing a decline of 10% on a reported basis compared to the prior year due to the coated 19 impact total Bayer collaboration revenue was 244 million of which we Ricky.

4200, 31 million for our share of net profits from my Leo sales outside the U.S total Sanofi collaboration revenue was 269 million in the second quarter, our share of the profits from the commercialization of non Io into bodies was 172 million. This compares favorably to profits of 39 million.

Marion McCourt: Current weekly new patient starts have recovered to approximately 87% of pre-pandemic levels, a sign of robust demand for Dupixent. Dupixent's compelling clinical profile enables the product to thrive, even in the current environment. Dupixent is administered at home and does not require laboratory testing or monitoring to initiate most new patients.

Even in the prior year period, which was driven by higher to take some profits before moving to expenses I will discuss our second quarter 2020. Other revenue line item, which we recorded 212 million up sharply from the 20 million in the prior year period. The primary driver of the year over year increases the recognition of 126 million.

Marion McCourt: Importantly, Dupixent is not an immunosuppressant, and we expect the U.S. launch of the 300 mg pre-filled pen in the third quarter, providing additional patient convenience and choice. Atopic dermatitis is its largest indication and remains a significant growth driver.

Associated with BARDA for our research in manufacturing efforts for both of bowler encoded 19, we record R&D reimbursements from BARDA in other revenues.

Moving to our expense base and starting with R&D non-GAAP R&D increased 36% year over year to 580 million driven by significant development costs were both our antibody cocktail in kids, our clinical trials for coated 19. In addition to higher headcount increased clinical manufacturing activities.

Marion McCourt: We continue to expand physician prescribing across both moderate and severe disease. However, to date, only a small percentage of biologic eligible patients have been treated, leaving substantial opportunity for more patients to benefit. Additionally, new long-term data demonstrates sustained efficacy over a three-year period, along with confirmed safety. We also continue to expand into younger populations. The USFDA recently approved Dipixen to treat children aged 6 to 11 years with moderate to severe atopic dermatitis, which impacts approximately 90,000 children in this country. It is the only biologic medicine approved for this population, and leading launch indicators are very encouraging. Many children suffering with moderate to severe atopic dermatitis are being treated by the same physicians, who have extensive clinical experience with their adolescent and adult patients and have great confidence in the Dupixent safety profile.

A portion of which will reimburse by BARDA next non-GAAP EPS gene expense increased 19% year over year to 301 million year over year increase was driven by the inclusion of Praluent commercialization costs in the us higher contributions to nonprofit patient assistance organizations in higher head count related costs.

Non-GAAP cost to collaboration contract manufacturing was 173 million compared to 79 million in second quarter 2019, the year over year increase is due to manufacturing costs associated with higher depicts in volumes sold by Sanofi moly production in Praluent supply percent of fees X.

Qs markets.

Turning now to taxes, the non-GAAP effective tax rate was 0.9%.

In the second quarter of 2020 compared to 19.1 person in the second quarter 2019, the lower tax rate versus last year was primarily due to increased tax benefits associated with stock option exercises in the realization of those benefits earlier in the calendar year compared to prior years.

Marion McCourt: Dupixent also continues to outperform in asthma, as measured by more new patient initiations over the last year compared to other biologic competitors. We see further opportunities to expand patient awareness of Dupixent through our national DTC campaign, which is underway. Among those already on treatment, COVID-19 has limited impact as patients adhere to their therapies to maintain and improve respiratory function. Finally, we see strong uptake in chronic rhinosinusitis with nasal polyps.

Shifting now to cash flow in the balance sheet year to date Regeneron generated 1.34 billion in free cash flow in the quarter. We spent 5 billion to repurchase approximately 9.8 million shares of our common stock as part of Sanofi sale of substantially all of their equity stake in Regeneron as Len mentioned the.

Marion McCourt: Since approval last year, patients have been initiated on Dipixent regardless of prior surgery. Demand has increased among ENTs and allergists due to the limited availability of elective surgeries in the last quarter. Overall, we see great opportunity for DEPIXENT, which is positioned for significant growth through expanded indications, age groups, and geographies. In closing, our teams and business remain resilient as we execute on our strategy to deliver value for customers and stakeholders. Now, I'll turn the call over to Bob.

Secondary offering in repurchase were strategic transactions that provided regeneron shareholders immediate accretion removes uncertainty regarding sanofis equity position and is a testament to our confidence in the strength of our business now and in the future. We ended the quarter with cash and marketable securities of 5.7 billion in 1.5 Bill.

In a debt financing under a bridge loan related to the Sanofi stake repurchase.

Now I'd like to spend a few moments to discuss the financial outlook for the remainder of the year.

We maintained or load the midpoint of our guidance on several expense items. Please refer to our press release in financial disclosures for entire updated 2020 guidance.

Here I will discuss the guidance items related to our increased efforts in the fight against Cobot 19, as we leverage our end to end capabilities of drug discovery development and manufacturing.

Robert E. Landry: Thank you, Marion. For the second quarter of 2020, Regeneron delivered strong results on both the top and bottom line. Our continued ability to generate this year-over-year growth is an encouraging signal of our diversified growth potential now and beyond COVID-19. For the second quarter, total revenues grew 24% year-over-year to $1.95 billion, driven by higher Sanofi collaboration revenues as a result of increasing Pixon sales. Additionally, we recorded significant revenues associated with our infectious disease efforts against both Ebola and COVID-19. These revenues are recorded in our other revenue line, bringing non-GAAP net income of $854 million.

We are updating our forecasted 2020, non-GAAP R&D expenses to be in the range of 2.27 to 2.37 billion.

For Cogs, we're raising our forecast for 2020 non-GAAP expenses, the being the range of 445 to 485 million the increase in both R&D in cost of goods sold guidance are related primarily to our efforts against coated 19 for R&D, we anticipate that more than half of the increased.

For 2020, R&D guidance will be reimbursed recovered 19 efforts those reimbursements will continue to be recorded in other revenue. We're also providing updated guidance for our tax rate. We anticipate our updated 2020 non-GAAP effective tax guidance to be in the range of 10% to 12%.

In conclusion Regenerons business remains healthy we continue to deliver strong year over year growth. Despite the global impact of coded 19, our strong balance sheet improved competitive outlook increasingly diversified commercial portfolio in robust pipeline position regeneron very well.

Robert E. Landry: Since Marion discussed our U.S. ILEA results, I will start with our Bayer and Sanofi collaboration. Starting with Bayer, ex-US ILEA net product sales, which are reported to us by Bayer, were 641 million, representing a decline of 10% on a reported basis compared to the prior year due to the COVID-19 impact. Total Bayer collaboration revenue was 244 million, of which we recorded 231 million for our share of net profits from ILEA sales outside. Total Sanofi collaboration revenue was $269 million in the second quarter.

For sustained long term growth.

Now with that I'd like to turn the call back to Justin.

Thank you Bob Stephanie that concludes our prepared remarks, we'd now like to open the call for QNX, we have several callers in the queue and to ensure they were able to addresses many questions as possible will address one question from each caller before moving to the next please go ahead Stephanie. Thank you as a reminder to ask a question you need to press star one on the telephone.

So with charter question press the pound key please stand by lot of composite Kunaev roster.

Robert E. Landry: Our share of the profits from the commercialization of non-IO antibodies was $172 million. This compares favorably to profits of $39 million in the prior year period, which was driven by higher depiction. Before moving to expenses, I will discuss our second quarter 2020 other revenue line item, in which we recorded $212 million, up sharply from the $20 million in the prior year period. The primary driver of the year-over-year increase is the recognition of $126 million associated with BARDA for our research in manufacturing efforts for both Ebola and COVID-19. We record R&D reimbursements from BARDA in other revenue. Moving to our expense base and starting with R&D. Non-GAAP R&D increased 36% year-over-year to 580 million, driven by significant development costs for both our antibody cocktail and Kevzar clinical trials for COVID-19, in addition to higher head count and increased clinical manufacturing activity, a portion of which was reimbursed by BART. Next, non-GAAP SG&A expense increased 19% year-over-year to $301 million.

And your first question from the line of parents land with Goldman Sachs.

Hi, good morning, Thanks for taking the question and thanks for all your efforts on the covered front.

Yes, I just had one on the manufacturing side was wondering if you can give us any more detail about your.

Manufacturing cost for the antibodies or if you could at least confirmed that these are well below a $100 per gram.

And if you want to answer that question I was just wondering Marianne if any perspective, you can share on opportunity for Dupixent in China.

And specifically what are you guys sake, and our Dl reimbursement. Thank you.

Parents I Atlanta victory can comment on our Cogs.

But to Marion concerning the comment on.

China.

So very happy keen on change. Thank you for the question we're really excited.

About the opportunity in China.

I'll also remind that Sanofi has the responsibility for China.

I'm very encouraged by the progress to date and as it relates to specifics on reimbursement I would guide asking ourselves. He colleagues team described that in more detail and as you know a tremendous market opportunity incredible unmet need and a remarkable clinical profile and we're really excited about the opportunity.

Your next question from the line of Geoffrey Porges with SVB Leerink.

Good morning, and thank you very much for taking the questions. Congratulations on the results.

Well the progress in the quarter.

Perhaps a few questions on the cover program.

George you referred to the animal sorry.

Hi, that's used 50 milligrams per kilogram is just tried a lot of antibody could you give us a sense of first is that the taught us that you expect to take forward in the pivotal trials for treatment and how much lower could it be for prophylaxis.

And secondly, if currency transaction visitors could you give us some indication of the number of our courses that you could enters its having supply for this year and next year given the available capacity now.

Robert E. Landry: The year-over-year increase was driven by the inclusion of prevalent commercialization costs in the U.S., higher contributions to non-profit patient assistance organizations, and higher headcount-related costs. Non-Gap Cost of Collaboration and Contract Manufacturing was $173 million compared to $79 million in the second quarter of 2019. The year-over-year increase is due to manufacturing costs associated with higher increases in volumes sold by Sanofi, Ebola production, and prevalent supply for Sanofi's ex-U.S. market, turning down a tax. The non-GAAP effective tax rate was 0.9% in the second quarter of 2020 compared to 19.1% in the second quarter of 2019.

Yes.

Leave model the doses in the blood levels.

From the Primate studies in order to design, our human studies and so.

We are hoping in targeting achieve similar blood levels in the humans is where we are achieving to achieve.

The relative efficacies in the Primate studies.

At those levels.

We are at the production level that we could be delivering hundreds of thousands of doses per month.

For the prophylactic dose level.

And tens of thousands of doses per month for the treatment levels, assuming there in those sorts of ranges that were predicting right now but of course, all that is all pending the trials and seeing what dose is really work hopefully some of the doses work and so forth. So there's still a lot to figure out that those.

The the the levels that we're targeting and those are the numbers. The doses that we are anticipating that we could deliver depending on how all the clinical trials workout.

Next question. Please your next question some of your on Weber with Cowen.

Hi, good morning, because the deal I played on Barbara.

Robert E. Landry: The lower tax rate versus last year was primarily due to increased tax benefits associated with stock option exercises in the realization of those benefits earlier in the calendar year compared to prior years. Now, shifting now to cash flow and the balance. Year-to-date, Regeneron generated $1.34 billion in free cash flow. In the quarter, we spent $5 billion to repurchase approximately 9.8 million shares of our common stock as part of Sanofi's sale of substantially all of their equity stake in Regeneron. As Len mentioned, the secondary offering and the repurchase were strategic transactions that provided Regeneron shareholders immediate accretion, removed uncertainty regarding Sanofi's equity position, and is a testament to our confidence in the strength of our business now and in the future. We ended the quarter with cash and marketable securities of $5.7 billion and $1.5 billion in debt financing under a bridge loan related to the Sanofi stake repurchase.

Thanks for taking our credit trends and the congrats on the high acquire and progress I just have a two questions regarding yara coding activity from Glenn.

The first crashing as.

Regarding the durability Anisette tee up John neutralizing antibodies isnt that some other antibody to other parts are kind of modifying the.

I think you'll now they're antibody candidates to either extended half life or minimize the epstein looking at it touches team can you kind of discuss.

You made any modifications turn your attention.

And my second question is regarding the prevention study essential to me that the ongoing phase three studies looking at the preventing infections in hospital contacts helping seconds or visual I'm just wondering.

The trial design looks more like post exposure prophylaxis I'm. Just wondering you can provide enhancing shells and gardening, you'll plans on the profession trials I was looking at like the peak quarter.

But prophylactic lack says.

The other highlights combinations.

Right.

Well as lot of questions sort of in there.

So one in terms of engineering, our antibodies historically, we've had very good success with achieving very good half lives.

Robert E. Landry: Now I'd like to spend a few moments discussing the financial outlook for the remainder of the year. We have maintained or lowered the midpoint of our guidance on several expenditures. Please refer to our press release and financial disclosures for our entire updated 2020 guidance. Here, I will discuss the guidance items related to our increased efforts in the fight against COVID-19 as we leverage our end-to-end capabilities of drug discovery, development, and manufacturing. We are updating our forecasted 2020 non-GAAP R&D expenses to be in the range of $2.27 to $2.37 billion. For COGS, we are raising our forecast for 2020 non-GAAP expenses to be in the range of $445 to $485 million. The increase in both R&D and cost of goods sold guidance is related primarily to our efforts against COVID-19. For R&D, we anticipate that more than half of the increase to our 2020 R&D guidance will be reimbursed for COVID-19 efforts. Those reimbursements will continue to be recorded in other revenue. We're also providing updated guidance for our tax rate. We anticipate our updated 2020 non-GAAP effective tax guidance to be in the range of 10% to 12%.

And duration.

And durability without making modifications, which as you know always come with certain risks.

So at least for our first generation antibodies are based on that historical success, we're going with.

On on modified in bodies on in terms of the concerns for antibody dependent enhancement.

We have done extensive studies and efforts on that including with.

Antibodies that we have or have not modified effector function.

And based on all of our data and all of our results.

We are going forward with.

Within bodies once again.

That are not modified based on the confidence in the data that we've generated.

With our preclinical experience.

[music].

And.

Finally, what was the last question the prevention setting or the prevention said, yes. So so some of those patients will have already been exposed, but there will be ongoing exposure as well so it's going to be both a pre and post exposure prophylaxis effort.

We will be characterizing whether the patient in the household that we're treating have already been exposed.

In terms of where they are already infected or not.

Our analysis.

Next question Stephanie.

Your next question is in line of Chris Raymond with Piper Center.

Thanks, So just on the.

Hi dose program I know from just looking at the Controls' Dot Gov website it looks like.

Robert E. Landry: In conclusion, Regeneron's business remains healthy, and we continue to deliver strong year-over-year growth despite the global impact of COVID-19. Our strong balance sheet, improved competitive outlook, increasingly diversified commercial portfolio, and robust pipeline position Regeneron very well for sustained long-term growth. Now, with that, I'd like to turn the call back to just say, Thank you, Bob.

Your larger Jimmy and Andy trials.

Projected to read out until 2022, but if there may be.

Our trial I think candela reading out in 2021, so I guess.

The question here is I know you guys haven't really guided to data yet but.

Yeah, we get a sense of the feasibility of this approach next year.

Especially given it's a higher dose and you got to be mindful of inflammation et cetera.

But also maybe remind us why you guys never went the route of using.

Operator: Stephanie, that concludes our prepared remarks. We'd now like to open the call for Q&A. We have several callers in the queue, and to ensure that we're able to address as many questions as possible, we'll address one question from each caller before moving to the next. Please go ahead, Stephanie.

Half life extension like a bio Palmer.

Thanks.

So I'll take the first but charges nikolay in terms of the date for we really haven't guided it depends on.

Sort of trying to do things in parallel get some phase two data what we're enrolling the phase threes.

Operator: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound.

So we'll just have to see how that comes that comes along George can comment on the difficulties biopolymer work.

Right. So we have been investing enormously in efforts with bio polymer extension and so forth and as we all know.

Operator: Please stand by while we compile the Q&A roster. And your first question is from the line of Terence Flynn with Goldman Sachs. Hi, good morning.

Has been demonstrated recently with the problems of of a major competitor.

We have set the very high bar.

For safety and for efficacy in particularly from the safety point of view and in all of our efforts we have not been satisfied.

Terence C. Flynn: Thanks for taking the question. And thanks for all your efforts on the COVID front. I just had one on the manufacturing side and was wondering if you could give us any more detail about your manufacturing costs for the antibodies, or if you could at least confirm that these are well below $100 per gram. And if you won't answer that question, I was just wondering, Marion, if you have any perspective you can share on the opportunity for Dupixent in China?

With our bio Palmer efforts that.

Those modifications.

Me that high bar, particularly for safety and so we have been hesitant to move those programs further into the clinic because of the concerns that we found with those approaches.

When we compare them and test them in our preclinical settings.

Leonard S. Schleifer: And specifically, would you guys seek NRDL reimbursement? Thank you. Terence, that's Len.

In terms of the high dose idea, we are hoping that we will be able to maintain that safety that high safety bar with the high dose I Leah but to extend the dosing as you know right now.

Marion McCourt: I don't think we can comment on COGS, but Marion can certainly comment on China. We're very encouraged by the progress to date, and as it relates to specifics on reimbursement, I would recommend asking our Sanofi colleagues to describe that in more detail. But as you know, tremendous market opportunity, incredible unmet need, and a remarkable clinical profile, and we're really excited about the opportunity. Your next question is from the line of Jeffrey Porges with SVV.

Studies show that depending on the patients about 50% of the patients can go to 12 dosing.

Using the current dose of Ilea and what we're hoping is that we may be able to increase the percentage of those patients who can go to longer term dosing using this higher dose the to achieve that in a in as safe.

In a manner as we have historically with I leave it to date.

Jeffrey Porges: Good morning, and thank you very much for taking the questions. Congratulations on the results and all the progress in the quarter. Perhaps a few questions on the COVID program. George, you referred to the animal data and the high dose used 50 milligrams per kilogram. Question for the audience: is that the dose that you expect to take forward in the pivotal trials for treatment, and how much lower could it be for prophylaxis? And secondly, if that indeed turns out to be the dose, could you give us some indication of the number of courses that you could envisage having supply for this year and next year, given the available capacity now?

So that's the basis of our strategy, Yeah, I just might add that we're not.

Sure this any evidenced that there's a dose dependent.

Effect on inflammation that lease with.

Hi quality leads that we make so much of its.

Certainly going to be the case.

Next question Stephanie.

Your next question is in the line of Robyn Karnauskas with to it.

Hi, guys. Thank you for taking my question.

Good morning, So question onto Cinemark you you announce your topline data. This morning, Keith just give us sometime in the hip and knee you talk more broadly about the market, but the hip and knee.

Monthly dose what the opportunity might be given that that that would be profile and your strategy for going after now that you know what that profile is going after other joint.

George D. Yancopoulos: We've modeled the doses and the blood levels from the primate studies in order to design our human studies, and so we are hoping and targeting to achieve similar blood levels in humans as what we achieve to achieve the relative efficacies in the primate studies. At those levels, we are at the production level where we could be delivering hundreds of thousands of doses per month for the prophylactic dose level and tens of thousands of doses per month for the treatment levels, assuming they're in those sorts of ranges that we're predicting right now. But, of course, all that is pending the trials and seeing what doses really work. Hopefully, some of the doses work, and so forth. There's still a lot to figure out. But those are the levels that we're targeting.

Thank you.

Well I think the biggest concern is obviously, having to do with the benefit risk and the safety profile.

Obviously, there is enormous need for alternatives in pain field.

And there are so many tens of millions of people who are living with Aastra us to authorize pain with limited options and concerns about all the available medications.

With all the concerns and problems with Opiods in particular, but also entered and so forth. All of these patients are potential candidates for the NGL inhibitors. So we are still awaiting and needing to read out additional safety data from our program and I think it's going to still be determined in terms of the relative.

Benefit risk as to how important.

George D. Yancopoulos: And those are the numbers of doses that we're anticipating that we could deliver, depending on how all the clinical trials work. Next question, please. Your next question is from the line of Yaron Werber with Cowan. Hi, good morning. This is Leo I for your own Verber.

A drug this can be for the so many patients who are in need here.

Yes.

Robert I just.

I wanted to measuring glad to see you've got new name their true sounds good.

I don't know if the truest, we'd like to pick regenerative truest, but at any rate the notion.

Yaron Werber: Thanks for taking our questions and congratulations on the start of the quarter and good progress. I just have two questions regarding your COVID-19 program. The first question is regarding the durability and safety of your neutralizing antigen.

Of of whether that the risk benefit is going to work as George pointed out I mean to some extent, we're sort of behind the the alliance of.

George D. Yancopoulos: It seems that some other antibody developers are kind of modifying the FC domain of their antibody candidates to either extend the half-life or minimize the FC-mediated toxin. Can you kind of discuss if you made any modifications to your candidate? And my second question is regarding the prevention study. It seems to me that the ongoing phase three study is looking at preventing infections in household contacts of the infected individual. I'm just wondering because the trial design looks more like a post-exporter prophylaxis. I'm just wondering if you can provide any details regarding your plans for the prevention trials. Well, there's a lot of questions sort of in there.

Lillian Pfizer in this class.

And they've announced the they think that they're action date is December. They recently said, there's not going to be in advisory panel. So we'll get to see as we're preparing our file and collecting rest why they will get see how the FDA views all this and what constraints or restraints, they might put or if they will they won't approve it so you'll get a little bit of an insight and.

To the class because it does appear that we see the same kinds of adverse events in general.

In terms of throughout the fees in these increased joint replacements.

That we sort of off drug.

That has been seen with the members of the class.

Great. Thanks for the question. Stephanie next question. Please. Thank you. Your next question supply of Geoff Meacham with Bank of America.

Hey, guys. Thanks for the question.

George D. Yancopoulos: So, one in terms of engineering our antibodies, historically, we've had very good success with achieving very good half-lives, duration, and durability without making modifications, which, as you know, always come with certain risks. So, at least for our first generation of antibodies, based on that historical success, we're going with unmodified antibodies. In terms of the concerns for antibody-dependent enhancement, we have done extensive studies and efforts on that, including with antibodies that we have or have not modified their effect or function. And based on all of our data and all of our results, we are going forward with antibodies that are not modified based on the confidence and the data that we've generated with our preclinical experience. Finally, what was the last question?

I had one I'm tired, obviously, you guys have basal cell and monotherapy arm as.

Label expansion opportunities, but just wanted to characterize your the trends in Twoq you today, maybe your market share is.

Do you feel like you're at saturation today are still an opportunity.

You know in your in your core indication today. Thank you.

Sure. So is this still relatively early in the launch for Latanya teams done a great job of establishing led tile for these patients with locally advanced or metastatic disease with the alternative of love tile.

But certainly there's significant opportunity to expand our utilization and obviously as you mentioned as we potentially get into future indications, even one for let tile.

Yeah, obviously, a big indication of where most of the sales in this space or is lung cancer in non small cell lung cancer and.

George D. Yancopoulos: The Prevention Study. Oh, the Prevention Study. Yeah.

So were exciting data, which will be basis of finally amount of therapy and were.

George D. Yancopoulos: So some of those patients will have already been exposed, but there will be ongoing exposure as well. So it's going to be both a pre- and a post-exposure prophylaxis effort. And we will be characterizing whether the patient in the household that we're treating has already been exposed in terms of whether they are already infected or not in our analysis. Next question, Stephanie.

Moving rapidly towards closing out the final patients enrolled in the chemo combination study so lung cancer is really big future opportunity.

If we can successfully complete compete there.

And of course ultimately.

As we tried to highlight.

It is a little disappointing how the PD one class has not had as.

Dramatic efficacy as one would have one in so many other cancer center settings, and Thats why we have are very exciting and innovative collection of bi specifics and other combination opportunities that now that we have our own PD one as a foundational.

George D. Yancopoulos: Your next question is from the line of Chris Raymond with Piper. Thanks. So just on the ILEA high-dose program, I know from just looking at the clintrials.gov website that your larger DME and AMD trials aren't projected to read out until 2022, but there may be a smaller trial, I think Candela, reading out in 2021. So I guess... And the question here is, and I know you guys haven't really gotten to data yet, but... Will we get a sense of the feasibility of this approach next year, especially given that this is a higher dose, and you've got to be mindful of inflammation, etc., but also maybe remind us why you guys never went the route of using a half-life extension like a biopolymer? So I'll take the first part, but George, you can take the lead.

Component, we can now be trying to increase in AD efficacy in all of these other cancer settings, where right now the PD. One class is not really shown as much benefit as one would want that maybe we can now really create enormous benefit in these settings by making the right combinations.

Particularly with our bi specifics, but with other combination opportunities as well.

Thanks, Jeff next questions Stephanie.

Your next question from the line of Ronny Gal Bernstein.

Good morning, Thank you, but they got question and congratulations nice progress back to the code 19 cocktail hour question I have it by the hospitalization trial, which is how do you monitor against patients mounting their own immune response, and kind of confounding did it that way and and related at the release of the.

George D. Yancopoulos: In terms of the date for, we really haven't been guided. It depends on, we're sort of trying to do things in parallel, get some phase two data while we're enrolling the phase threes. So we'll just have to see how that comes along, and George can comment on the difficulties of biopolymer, Right. So we have been investing enormously in efforts with biopolymer extension and so forth. And as we all know, and as has been demonstrated recently with the problems of a major competitor, Alia sets a very high bar for safety and for efficacy, and particularly from the safety point of view. And in all of our efforts, we have not been satisfied with our biopolymer efforts so that those modifications meet that high bar, particularly for safety. And so we have been hesitant to move those programs further into the clinic because of the concerns that we found with those approaches when we compared them and tested them in our preclinical settings.

Biomarker data late summer does that tell us something about the completion of the efficacy already read outs or is there. Some relationship that we can follow are they going to press released the completion of enrollment just to give us an idea where how do we know out there antibody has exceeded its coming.

These are all great questions and in fact, we are analyzing data exactly.

With regards to some of the points and concerns that you have we are measuring among the biomarkers were measuring patients in the Dodgers response, there antibody titers, and we're comparing and dividing the patients based on their baseline levels of antibody titers to see whether the patients who respond the bastard the people who.

Our now mounting or or are too early in the course of their disease.

And we have this adaptive design, we are going to continue to.

Generate data and evaluate data, we will hopefully be reporting some that data publicly but then using that data and make decisions in terms of the adapt to future portions of our design.

Okay. Thanks next question please.

George D. Yancopoulos: In terms of the high-dose cilia, we are hoping that we'll be able to maintain that safety, that high-safety bar with the high-dose cilia. But to extend the dosing, as you know right now, studies show that, depending on the patients, about 50% of the patients can go to Q12 dosing using the current dose of ILEA. And what we're hoping is that we may be able to increase the percentage of those patients who can go to longer-term dosing using this higher dose, but to achieve that in as safe a manner as we have historically with ILEA to date. So that's the base of our strategy. Yeah, I just might add that we're not sure there's any evidence that there's a dose-dependent effect on inflammation, at least with... Quality Idea. Next question, Stephanie.

Our next question from the line of Tim Anderson with Wolfe Research.

Thank you I've a question on Dupixent.

And fuel PD.

Today remains the Holy Grail for asthma, biologics and there have been.

Earlier preliminary fuel PDH.

The data sets with other products that look good.

Only to fail in phase three.

I'm wondering if you can put into context the results from the interim look at your fuel PD trial that you've referenced.

Or at least whether those go no go criteria for the same it that other biologics have relied on or was that interim efficacy bar set higher with dupixent than where the competitor biologics at the same stage of development.

Yeah.

I'm I'm not sure that the earlier biologics that you're referring to demonstrate much different.

Data in their phase two in their phase three programs in the problems where was that at best they were demonstrating somewhere around a 15% reduction in beer exacerbations.

Robyn Kay Shelton Karnauskas: Your next question is from the line of Robyn Karnauskas. Hi guys, thank you for taking my question and good morning. So, question on Cicinema, since you announced your top-line data this morning, can you just give us some sense for the hip and the knee, you talk more broadly about the market, but the hip and the knee, what a monthly dose, what the opportunity might be, given that that would be the profile and your strategy for going after, now that you know what that profile is, going after other joints. Well, I think the biggest concern is obviously having to Obviously, there is an enormous need for alternatives in the pain field, and there are so many tens of millions of people who are living with osteoarthritis pain with limited options and concerns about all the available medications with all the concerns and problems with opiates in particular but also with NSAIDs and so forth.

And depending on the phase three studies those were on the border of achieving clinical significance and Thats why those programs Didnt move forward.

So what we did not release the details of the bar that we set but we did say that the bar that we said had to do with exacerbations and we had to achieving minimum threshold reduction in exacerbations in order to trigger going forward and triggering the initiation of an additional.

Phase three so obviously the fact that we met a threshold bar for reduction in exacerbation I think.

Great.

Some.

Excitement.

That.

Assuming that we can continue to achieve these sorts of reductions in exacerbations that this could be an important drug to see LPD.

I just wanted to act as I, just want to Echo what George said, they because this is a little different than most other sort of you know futility analyses were.

George D. Yancopoulos: All of these patients are potential candidates for the NGF inhibitor, so we are still awaiting and needing to read out additional safety data from our program. And I think it's going to still be determined in terms of the relative benefit risk as to how important a drug this can be for the so many patients who are in need. Yeah, I know. Robyn, I just wanted to mention I'm glad to see you've got a new name there, Truist. Sounds good, but I don't know if it's the best.

You say well, even if you have a slim chance you sometimes you let the trial go forward as George said and then just really trying to put of.

Exclamation. It was a stringent that means that it was hard to pass that bar, because obviously sanofi and regeneron, we didn't want to take on another whole phase three.

Program, which is obviously takes a lot of time money in effort.

Leonard S. Schleifer: We like to think Regeneron is the best. But at any rate, the notion of whether the risk-benefit's going to work, as George pointed out, I mean, to some extent, we're sort of behind the alliance of Lilly and Pfizer in this class. And they've announced, I think, that their action date is December. And they recently said there was not going to be an advisory panel.

Unless we were told we didnt see the data we just know that we passed the stringent.

Our fuel.

And the bar was for reduction, meaning exacerbations right.

Next question please.

Your next question from the line of Yachting soon job with Guggenheim partners.

Hey, guys. Congrats on all the progress that question on the commercial front for our with regard to though that the cocktail approach that you have can you can you comment on how do you see the adoption in light of depletion data that we are seeing with vaccine given that they provide a little bit longer protection is that the antibody approach has a lower potential.

Leonard S. Schleifer: So we'll get to see, as we're preparing our dossier and collecting the rest of our data, how the FDA views all this and what constraints or restraints they might put on it, or if they will or they won't approve it. So you'll get a little bit of an insight into the class because it does appear that we see the same kinds of adverse events in general, in terms of what's happening, that we saw off the drug, that has been seen with... Thanks for the question. Stephanie, next question, please.

To fair or should the vaccine or.

And enhance you are.

Guaranteed protection.

Jeff Meacham: Thank you. Your next question is in the line of Jeff Meacham with Bank of America. Hey, guys. Thanks for the questions. I had one.

Maybe perhaps if you can talk about how the market plays out once you have vaccine available. Thank you.

I wasn't sure whether there was two parts of the question whether some insight on the technical aspect. If Georgians today, you can instantly answer that but from the commercial side.

Marion McCourt: I'm Tyler. Obviously, you guys have basal cell and monotherapy lung as label expansion opportunities, but just wanted to characterize, you know, your trends in 2Q today, and maybe your market share is. Do you feel like you're at saturation today, or is there still an opportunity, you know, in your core indication today? Thank you. Sure, but, you know, this is still relatively early in the launch for Liptio. The team has done a great job of establishing Liptio for these patients with locally advanced and metastatic disease, but certainly, there's significant opportunity to expand our utilization and, you know, obviously, as you mentioned, as we potentially get into future indications, even more for Liptio. Yeah, obviously, the big indication where most of the sales in this space are lung cancer, non-small cell lung cancer.

I think it's what's been said for a long time this.

A passive immunization with an antibody cocktail provides immediate community. So in this setting up until this vaccine. If this comes first that would be great, but even after this vaccine there will be many people who are not vaccinated Oahu specs in nation effects wore off and they got ill.

Or if they were vaccinated they didnt get enough of a response.

So we think there's a lot of places for this.

Passive immunization with an antibody cocktail George I'm not sure was there you follow that have a pointer.

No I think that you got it yep.

Next question please.

Your next question from the line Althea young with Cantor.

Hey, guys. Thanks for taking my.

Question and I was just kind of curious about what's going on with adverse element for the NPL three program I know that you're filing, but I thought it with a relatively small market opportunity, but just wanted to kind of think about that and what are the potential extension opportunities from there. Thanks.

Marion McCourt: So our exciting data, which will be the basis of a filing amount of therapy, and we're moving rapidly towards closing out the final patients enrolled in the chemo combination study, so lung cancer is really the bigger future opportunity. And, of course, ultimately, as we tried to highlight, it is a little disappointing how the PD-1 class has not had as much success. Benefit is one would want to say that maybe we can now really create enormous benefit in these settings by making the right combinations, particularly with our buy specifics, but with other combination opportunities. Thanks, Jeff.

Yeah. This is evidenced Pts three you said have been active members little hard to here, Yeah, Oh, sorry, yeah, but yeah, I think I think I guided commercial potential and life beyond that and Jason as well.

Right. We think this is a very important proof of concept setting.

These are if we get approved as you said, it's it's for homozygous FH, it's for a very rare genetic population.

George D. Yancopoulos: Next question, Stephanie. Your next question is from the line of Ronnie Gao. Good morning, thank you for taking our questions and congratulations on the nice progress. Back to the COVID-19 cocktail. One question I have is about the hospitalized patient trial, which is how do you monitor patients mounting their own immune responses and kind of confounding the data with that? And related, does the release of the biomarker data late summer tell us something about the completion of the efficacy readouts, or is there some relationship there we can follow, or are you going to press release the completion of the enrollment, just to give us an idea about how we know the antibody eff These are all great questions, and in fact, we are analyzing our data exactly with regard to some of the points and concerns that you have.

And particularly what we showed was efficacy in patients who have no LDL receptor function. So that means that this drug.

And this pathway work totally different than all other drugs that lower lip isn't cholesterol.

And it may have important growth opportunities. After this in the sense that.

Since it is lowering lipids not only cholesterol, but triglycerides.

By these independent mechanisms.

It is entirely possible and we are thinking about it about whether there's a broader opportunity eventually for this class of drugs.

But we're also very excited about the near term opportunity that we hope we're going to get.

Agreement were from the FDA shortly in the homozygous FH population, particularly those who don't respond to any of the existing drugs and in all I. Just you mentioned size of the population. The if this is a rare condition and in the U.S. Theres a population of patients about 1300 easily.

Ronnie Gao: We are measuring, among the biomarkers, patients' endogenous response, their antibody titers, and we're comparing and dividing the patients based on their baseline levels of antibody titers to see whether the patients who respond best are the people who are not progressing or are too early in the course of their disease. And we have this adaptive design. We are going to continue to generate data and evaluate data. We will hopefully be reporting some of that data publicly, but then using that data to make decisions in terms of the adaptive future portions of our design. Thanks.

Be eligible candidates that we feel we'd have an opportunity to help very significantly with is somewhere in challenging disease ex us it's about 1700.

I think where time for one more question Stephanie.

Thank you. Your final question will come from the line of Evan Seigerman with credit Suisse.

Thanks for squeezing me in there at the end.

Looking at that antibody data in September with that be assuming that positive is that enough to get an easy way from the FDA and if not what else do you need to generate and when could we see that data. Thank you.

Well it all depends it will all depend on the data and how good it looks so there's so many variables I think it's really impossible to give a fair answer that question.

George D. Yancopoulos: Next question, please. Your next question is from the line of Tim Anderson with. Thank you. I have a question on Duplix and COPD.

Okay. Thanks.

Thanks, Evan Thanks for everybody dialing in this concludes our call Bob Landry in the IR team will be available after the call answer further questions stay well unsafe everyone. Thank you very much.

Timothy Minton Anderson: COPD remains a holy grail for asthma biologics, and there have been earlier preliminary COPD data sets with other products that looked good, only to fail in phase three. So I'm wondering if you can put into context the results from the interim look at your COPD trial that you've referenced, or at least whether those go-no-go criteria were the same that other biologics have relied on, or was that Interim Efficacy Bar set higher with DuPage? Editor of Biologics at the same time. Yeah, I'm not sure that the earlier biologics that you're referring to demonstrated much different data in their phase 2 and their phase 3 programs. And the problems were that, at best, they were demonstrating somewhere around a 15% reduction in their exacerbation.

Thank you. This does conclude today's conference call you may now disconnect.

Okay.

[music].

George D. Yancopoulos: And depending on the phase 3 studies, those were on the border of achieving clinical significance, and that's why those programs didn't move forward. So we did not release the details of the bar that we set, but we did say that the bar that we set had to do with exacerbations. And we had to achieve a minimum threshold reduction in exacerbations in order to trigger going forward and initiating the initiation of an additional phase 3. So obviously, the fact that we met a threshold bar for reduction in exacerbations creates some excitement, and assuming that we can continue to achieve these sorts of reductions in exacerbations, this could be an important drug for COPD. I just want to echo what George said there because this is a little different than most other sorts of futility analyses, where, you know, you say, well, you know, even if you have a slim chance, sometimes you let the trial go forward.

George D. Yancopoulos: As George said, and I'm just really trying to put an exclamation point on it, it was stringent. That means that it was hard to pass that bar, because obviously, Sanofi and Regeneron didn't want to take on another whole phase three program, which obviously takes a lot of time, money, and effort unless we were told, and we didn't see the data. We just know that we passed this stringent bar. And the bar was set for reduction in exacerbation. Next question, please. Your next question is from the line of Yatim Sunja with Guggenheim Park.

Leonard S. Schleifer: Hey guys, congrats on all the progress. A question on the commercial front with regard to the cocktail approach that you have, can you comment on how you see adoption in light of the recent data that we are seeing with vaccines given that they provide a little bit longer protection? Is that the antibody approach has a lower potential to fail versus a vaccine and hence you are almost guaranteed protection? Maybe, perhaps, if you could talk about how the market plays out once you have the vaccine available. I wasn't sure whether there were two parts to that question, whether there was some insight into the technical aspect, or whether George understood that.

Yatim Sunja: I don't know the answer to that, but from the commercial side... I've said for a long time that passive immunization with an antibody cocktail provides immediate immunity, so in the setting of, until there's a vaccine, if this comes first, that would be great, but even after there's a vaccine, there will be many people who are not vaccinated or whose vaccination effects wear off, and they get ill, or if they were vaccinated, they didn't get enough So we think there are a lot of places for this passive immunization with an antibiotic. George, I'm not sure if it was...

Leonard S. Schleifer: Follow that. Yeah, I think that you've got it. Yep. Thanks, John. Next question, please. Your next question's from the line of Althea Young. Hey guys, thanks for taking my question, and I was just kind of curious about what's going on with Evacenomab for the NGPTEL 3 program. I know that you're filing, but I thought it was a relatively kind of small market opportunity, but just wanted to kind of think about that and what are the potential extension opportunities from their thing. Yeah, this is Ang PTL-3. You said epinacumab. It was a little hard to hear. Yeah, oh, sorry. Yeah, but yeah, I think I've got it.

George D. Yancopoulos: Commercial potential and life beyond that indication as well. We think this is a very important proof of concept setting. If we get it approved, as you said, it's for homozygous FH, it's for a very rare genetic population, and particularly what we showed was efficacy in patients who have no LDL receptor function. So that means that this drug and this pathway work totally differently than all other drugs that lower lipids and cholesterol. And it may have important growth opportunities after this in the sense that since it lowers lipids, not only cholesterol but triglycerides, by these independent mechanisms, it is entirely possible, and we are thinking about it, about whether there's a broader opportunity for this class of drugs in the future.

George D. Yancopoulos: But we're also very excited about the near-term opportunity that we hope we're going to get agreement from the FDA shortly in the homozygous FH population, particularly those who don't respond to any of the existing drugs. And I'll add the size of the population that you mentioned. This is a rare condition, and in the U.S., there's a population of patients about 1,300 who would be eligible candidates that we feel we'd have an opportunity to help very significantly with this rare and challenging disease. Outside the U.S., it's about 1,700.

George D. Yancopoulos: I think we have time for one more question, Stephanie. Thank you. Your final question will come from the line of Evan Seigerman. Thanks for squeezing me in there at the end. Looking at the antibody data in September, would that be, assuming it's positive, enough to get an EUA from the FDA? And if not, what else do you need to generate and when could we see that data?

[music].

Evan Seigerman: Thank you. Well, it'll all depend on the data and how good it looks. So there are so many variables that I think it's really impossible to give a fair answer to that question.

George D. Yancopoulos: Okay, thanks. Thanks, Evan. Thanks for everybody dialing in. This concludes our call. Bob Landry and the IR team will be available after the call to answer further questions. Stay well and safe, everyone. Thank you very much.

Operator: Thank you. This does conclude today's conference call. You may now disconnect.

Operator: [inaudible] © The Bulletproof Executive 2013,. .. .. .. ... ?? ?? ?? ?? [inaudible] © The Bulletproof Executive 2013,.. , , , Ladies and gentlemen, thank you for standing by and welcome to the Regeneron Pharmaceuticals Q2 2020 earnings conference call. At this time, our participant lines are in a listen-only mode.

Operator: After this presentation, please leave your question and answer. To ask a question during this session, you'll need to press star 1 on your telephone. Please be advised that today's call is being recorded. If you require any further assistance, please press star zero. Thank you. Justin Hoko

Operator: I will now turn the call over to Stephanie. Good morning, good afternoon, and good evening to everyone listening around the globe.

Operator: Thank you for your interest in Regeneron Pharmaceuticals and welcome to the second quarter 2020 conference call. An archive of this webcast will be available on our website. Joining me today on the call are Dr. Leonard Schleifer, Founder, President, and Chief Executive Officer; Dr. George Yancopoulos, Co-Founder, President, and Chief Scientific Officer; Marion McCourt, Senior Vice President and Head of Commercial; and Bob Landry, Executive Vice President and Chief Financial Officer. 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 businesses, financial forecasts and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement issues, intellectual property, pending litigation and other proceedings, and competition. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in the statement.

Operator: A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarterly period ended June 30, 2020, which was filed with the SEC today. Regeneron does not undertake any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. In addition, please note that GAAP and non-GAAP measures will be discussed in today's call. Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available in our financial results press release, which can be accessed on our website.

Operator: 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. Thank you, Justin.

Leonard S. Schleifer: And thanks to everyone for joining the call. I hope all of you are staying safe and well. We very much appreciate your efforts to join given the pandemic conditions and, on top of that, in the Northeast, some power disruption from the storm. But business continues.

[music].

Leonard S. Schleifer: We had an eventful and productive second quarter in terms of financial results, business development, and corporate accomplishments. In the second quarter, our results demonstrated resilience and strength despite the impact of the ongoing COVID-19 pandemic. In addition to driving double-digit top and bottom-line growth, we will continue to deliver meaningful advances in our broad and innovative pipeline, as well as in our fight against COVID-19 with our novel antibody cotton. Regeneron continues to execute well in this unprecedented time for our company, our nation, and the world. Starting with our product. ILEA global net product sales were $1.75 billion in the second quarter, a modest decline of 6% compared to the prior year.

Leonard S. Schleifer: In the U.S., we generated sales of $1.11 billion. With a pronounced and sustained rebound in demand in May and June following the decline in sales we experienced early this year, this rebound has continued into July, and demand is now approaching pre-COVID levels. Efficacy, safety, and convenience of ILEA have proven to be even more viable in the world of COVID-19. And as you'll hear from Marion, Aaliyah outperformed the broader anti-VEGF class this quarter. Demand for Dubixin also proved to be robust in the second quarter, with global sales growth of 70% compared to last year. Sales were nearly $1 billion on continued market penetration in atopic dermatitis, asthma, and new lung diseases. Adding to the duplication...

Leonard S. Schleifer: The FDA approved a new indication for atopic dermatitis in children aged 6 to 11. Furthermore, we demonstrated dramatic results in eosinophilic esophagitis, where patients reported a nearly 70% reduction in symptoms, further exemplifying the potential of DuPix, Bend the arc, a certain type 2. We look forward to additional Dupixent miles, including an upcoming phase 3 readout in Pediatric Asthma and enrollment in a second phase 3 study in chronic obstructive pulmonary disease. In our patience and custom, we have a tremendous amount of enthusiasm for this product, and we are still in the early days of unlocking its full potential with our partners. In oncology, libtio is the leading systemic treatment. Painius Squamous Cell Carcinoma, We are seeking approvals in basal cell carcinoma and non-small cell lung cancer, with regulatory filings to be. With our chemotherapy combination study in non-small cell lung cancer nearing full enrollment, our excitement for Libtio continues to grow.

Leonard S. Schleifer: Beyond Liptaya, we are broadening and advancing our biospecifics portfolio, generating further momentum for our oncology strategy. Now, turning to our efforts to fight COVID-19. We are advancing the development of a novel antibody cocktail known as REGN-CoV-2 that may both treat and prevent infection from the SARS-CoV-2 virus. We are now in phase two and phase three trials and hope to generate initial data by the end of September, as George will discuss in further detail. We have also signed two major agreements in recent weeks.

Leonard S. Schleifer: We announced a $450 million dollar agreement with BARDA and the U.S. Department of Defense to manufacture REGN-CoV-2. We also signed a six-year, $345 million agreement with BARDA for our novel Ebola antibody cox, further demonstrating the potential of our end-to-end technology to deliver shareholder value. Addressing Infectious Disease Threats Finally, on the corp- Contemplate, completed a large secondary... of more than 13 million shares of our common stock held by Sanofi. Using our Strong Balance Sheet, we also repurchased $5 billion on 9.8 million shares.

Ladies and gentlemen, thank you for standing by and welcome to the Regeneron Pharmaceuticals, Q2, 2020 earnings Conference call.

At this time all participant lines are in a listen only mode.

After this brief presentation with your question and answer session.

Asked a question during the question you need to press star one under telephone.

Please be advised today's call is being recorded.

If you require any further assistance. Please press star zero. Thank you Justin Holdco I'll now turn the call over to you.

Thank you Stephanie good morning, good afternoon, and good evening, everyone listening around the globe. Thank you for your interest in Regeneron Pharmaceuticals, and welcome to the second quarter 2020 Conference call. An archive of this webcast will be available on our website. Joining me today on the color Dr., Leonard Schleifer, founder President and Chief Executive Officer.

Leonard S. Schleifer: Effectively eliminating their ownership position in our, For Regeneron shareholders, this transaction provided immediate accretion and removed a significant overhang related to the expiration of Santa Fe's lock-up period at Regeneron is a business that is indeed firing on all cylinders. I want to thank all of our colleagues across the board who have been working with Resolve and Resilience. Extraordinary times of the pandemic. Our strong business, Cash Flow, Balance, Advancement of the Next Generation of Innovation, and emerged from the pandemic to drive continued long, Now I'll turn the call over to you. Thank you, Len. And with all of us still in the throes of the COVID-19 epidemic, I will start with an update on our antiviral antibody cocktail that has the potential to both possibly protect against infection and also treat those already infected. Based on our ball program.

Dr. George Yancopoulos co founder President and Chief Scientific Officer marrying the court senior 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 today I'd also like to remind you that remarks made on todays call include forward looking statements about regeneron such.

Statements may include but are not limited to those related to regeneron.

And its products and businesses financial forecast and guidance development programs and related anticipated milestones collaborations finances regulatory matters payer coverage and reimbursement issues intellectual property pending litigation and other proceedings and competition. Each forward looking statement is subject to risks and uncertainties that could.

Cause actual results and events to differ materially from those projected and statement a.

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

George D. Yancopoulos: With our new non-humate primate data for our COVID-19 cocktail, as well as our understanding of the immune response, we believe that our COVID-19 treatment is well-positioned to help patients prior to and early during infection. We initiated our clinical program in June, barely five months after we started this treatment. Developing this treatment. Our rapid timeline was possible due to our VelociSuite technologies, which were developed in-house over decades to allow for specific turnkey disease interventions and were recently applied to develop our similar approach against Ebola, which we hope will prove to be the first treatment approved for this disease with a PDUFA date in October. We are currently conducting four trials of Regeneron-CoV-2, our antibody cocktail. One in hospitalized COVID-19 patients and a second, ambulatory study in outpatients who are diagnosed with COVID-19.

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 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 in the IR team will be available to answer further questions with that let me turn the call over to our President and Chief Executive Officer, Dr. lunch life.

Thank you Justin Thanks to everyone for joining the call.

All of you are staying safe and well.

We very much appreciate you efforts to join given the pandemic conditions and even on top of that northeast some power disruption from the storm.

But business continues we had an eventful unproductive second quarter in terms of financial results business development and corporate accomplishments in the second quarter, our results demonstrated resilience and strength.

George D. Yancopoulos: A third, preventative study in household contacts of COVID-19 patients being carried out in collaboration with the National Institute of Allergy and Infectious Diseases, and a fourth multi-dose healthy volunteer study. Our studies are adaptive in nature as we learn more about the virus in our antibody cocktail, and other studies are being planned as well. All of these studies have passed several safety assessments with no safety concerns observed to date.

Despite the impact of the ongoing cobot 19 pandemic.

In addition to driving double digit top and bottom line growth, we continued to deliver meaningful advances in our broad and innovative pipeline as well as enough fight against covert 19, with our novel antibody cocktail Regeneron continues to execute well in this unprecedented time for our company.

George D. Yancopoulos: Despite the challenging environment in which these studies are being conducted, we are targeting to report initial virology and biomarker data from the treatment studies by the end of September, with clinical outcome data to follow as enrollment progresses. In June, we published two important papers in Science on our antibody cocktail, in which we describe the details of how the two antibodies in our cocktail block the coronavirus spike protein and, importantly, highlighted the significance of using an antibody cocktail versus a single antibody approach. We showed that the cocktail approach avoided viral escape due to viral mutation, which rapidly occurs when using single antibody approaches. In addition, we have recently generated important data on non-human primates, which has been posted on bioRxiv.

Our nation in the World.

Starting with our products I Leah global net product sales were $1.75 billion in the second quarter, a modest decline of 6% compared to the prior year.

In the U.S., we generated sales of 1.11 billion with a pronounced and sustained rebound in demand in May and June following the decline in sales we experienced in early April.

This rebound has continued into July into July and demand is now approaching pre covered levels.

The efficacy safety and convenience of I Leah have proven to be even more valuable in the world of covert 19, as you'll hear from Marion idly outperformed the broader anti VEGF class this quarter to.

Demand for Dupixent also proved to be robust in the second quarter with global sales growth of 70% compared to last year sales were nearly $1 billion on continued market penetration in eight topic dermatitis asthma and new launches.

George D. Yancopoulos: These studies showed that in this setting, our antibody cocktail can not only effectively prevent infection in primates, matching or exceeding recently published prevention data achieved with vaccine approaches, but also that our cocktail can treat those already infected by accelerating viral elimination. I next want to highlight the outside support we have received for our strategy. In addition to conducting our Phase 3 prevention study in collaboration with the NIAID, which subsequently expands our reach to investigate our cocktail in the preventative setting, we recently signed a manufacturing contract with BARDA as part of Operation Warp Speed to make initial lots of our cocktail at risk so that the drug could be available as soon as possible, if proven efficacious and approved by the FDA.

Adding to the Dupixent momentum the FDA approved a new indication for atopic dermatitis and children, aged six to 11.

Furthermore, we demonstrated dramatic results and eosinophilic esophagitis, where patients reported in nearly 70% reduction in symptoms.

Further exemplifying the potential of Dupixent to bend the arc certain type two inflammatory diseases, we look forward to additional dupixent milestones, including an upcoming phase three read out in pediatric asthma and enrollment of a second phase three study in chronic obstructive pulmonary disease.

George D. Yancopoulos: Well, we are all hoping that vaccines prove successful, and we ourselves are partnering on some novel second-generation vaccine approaches. We believe that our neutralizing antibody cocktail could play an important role as a rapid first line of defense in those for whom a vaccine is not available and, in the long term, could also provide protection for those least likely to respond well to a vaccine, such as the elderly and immunocompromised.

We in our patience and customers have a tremendous amount of enthusiasm for this product and we are still in the early days of unlocking its full potential with a partner Santa Fe.

In oncology live tile is the leading systemic treatment for cutaneous squamous cell carcinoma, we're seeking approvals and basal cell carcinoma, and non small cell lung cancer with regulatorily <unk> regulatory filings to be submitted imminently.

George D. Yancopoulos: Moreover, unlike a vaccine, and as supported by our initial primate studies, our cocktail may not only prevent infection but could also have the potential to treat those already infected. Moving on to our efforts outside of COVID-19 and starting with DuPix, the demonstrated safety and efficacy of Dupixen are further bolstered by the recent FDA approval in children with moderate to severe atopic dermatitis, including children as young as six

Chemotherapy combination study in non small cell lung cancer nearing full enrollment.

Excitement for live tie all continues to grow.

Beyond the tire, we're broadening and advancing our bi specifics portfolio generating further momentum for our oncology strategy.

Turning to our efforts to fight covert 19, we are advancing the development of a novel antibody cocktail known as our E G and she'll be too that may both treat and prevent infection from the stars Coke to virus.

George D. Yancopoulos: And we are not stopping there, as we are conducting a study in even younger atopic dermatitis patients. And for children with asthma, we plan to submit a BLA supplement for approval in pediatric asthma by the end of the year, pending upcoming Phase 3 data. We're also enhancing convenience for all patients with the recent FDA approval of our 300 milligram auto-injector. Outside of the United States, Dupixen was approved in China recently, which represents a major milestone as we work to ensure patients everywhere have access to this life-changing medicine.

We are now in phase two and phase three trials and hope to generate initial data by the end of September as George will discuss in further detail.

We also signed two major agreements in recent weeks, we announced a $450 million agreement with BARDA and the U.S. Department of defense to manufacture, our EG and Coke too.

We also signed a six year 345 million dollar agreement with BARDA for our novel Ebola antibody cocktail further demonstrating the potential of our end to end technologies to deliver shareholder value in addressing infectious disease threats.

George D. Yancopoulos: Our DUPIXEN clinical program continues to deliver positive results in additional type 2 inflammatory indications. In May, we announced that we met the primary and key secondary endpoints in Part A of our pivotal trial in eosinophilic esophagitis. Patients treated with dupixan demonstrated significant clinical and anatomic improvements, with almost a 70% reduction in disease symptoms compared to an approximate 30% reduction for patients on placebo, as demonstrated by the dysphagia symptom questionnaire.

Finally on the corporate front, we contemplated excuse me, we completed a large secondary offering of more than 13 million shares of common stock held by Sanofi.

Using our strong balance sheet, we also repurchased $5 billion or 9.8 million shares from Santa fee effectively eliminating their ownership position in our company and demonstrating our confidence in the trajectory of our business.

For Regeneron shareholders. This transaction provided immediate accretion and removed a significant overhang related to the expiration of Santa fees lockup period at the end of this year.

George D. Yancopoulos: We are currently enrolling Part B of this trial and communicating with regulators about filing requirements for this indication. In addition, the first pivotal depiction trial in patients with chronic obstructive pulmonary disease typified by type 2 inflammation, or type 2 COPD, completed a pre-specified analysis by the Independent Data Monitoring Committee requiring a certain threshold reduction in exacerbations, which was met, and thus triggered opening a second pivot Approval in type 2 COPD would unlock another important opportunity for depiction to help patients with type 2 inflammatory disease who currently have limited options. Moving on to our oncology portfolio, and starting with our PD-1 antibody, Liptio. At the virtual ASCO meeting, we presented clinically meaningful cutaneous squamous cell carcinoma data follow-up, followed by a label update as well.

Regeneron is a business that is indeed firing on all cylinders. We thank all of our colleagues across the company who have been working with resolve and resilience in these extraordinary times.

Of the pandemic.

Our strong business performance cash flow balance sheet and advancement of the next generation of innovations for important medical needs has us positioned to weather covert 19 and emerge from the pandemic to drive continued long term growth now I'll turn the call over to George.

Thank you Alan.

And with all of its still in the throws of the covert 19 epidemic I will start with an update on our anti viral antibody cocktail that has the potential to both possibly protect against infection and also treat those already infected.

Based on our Bowl program.

Our new non human primate data for our covert 19 cocktail as well as our understanding of the immune response, we believed that our covert 19 treatment is well positioned to help patients prior to and early in infection. We initiated our clinical program in June nearly five months. After we started this.

George D. Yancopoulos: As reported at ASCO, with up to three years of follow-up, while the overall response rates remain stable, approaching 50%, the complete response rates have climbed to 20% in metastatic CFCC, increasing from the 7% rate reported in the initial primary analysis, providing one of the most dramatic examples of ongoing and prolonged benefit from an immunotherapy treatment. Moreover, these data firmly establish Leptile.

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Developing the street.

Our rapid timeline was possible due to a lots of suite technologies, which were developed in house over decades to allow for specific turnkey disease interventions and were recently applied to develop our similar approach against a bowl, which we hope will prove to be the first treatment approved for this disease with the PDUFA date in October.

We're currently conducting four trials of regeneron constitute our antibody cocktail one in hospitalized covert 19 patients a second ambulatory studying how patients who are diagnosed with over 19, a third prevented us studying household contacts have covert 19 patients being carried out in collaboration.

George D. Yancopoulos: We are the first in class for this dermato-oncology cancer setting with compelling long-term clinical data. In addition, last quarter, we announced positive first-in-class data for a second dermato-oncology indication, that is, basal cell carcinoma, which we will be submitting for regulatory review. Finally, we're excited about the opportunity for Leptio in non-small cell lung cancer based on our recent positive phase 3 trial with Leptio as monotherapy in PD-L1 high patients, which we will also be submitting for regulatory review. And we have completed screening patients for enrollment in our follow-on chemocombination study in lung cancer. Leptio is foundational to our oncology strategy, and we are making significant progress with Leptio in skin cancers, lung cancers, and our numerous combination and collaborative studies. Additionally, our CD3 bispecifics clinical program is moving forward, despite operational challenges imposed by the COVID-19 pandemic. Regeneron 1979, our CD20 by CD3 bispecific antibody, has shown robust activity in both follicular lymphoma and more aggressive diseases, including diffuse large B cell lymphoma.

With the National Institute of allergy and infectious disease.

And afford multi dose healthy volunteer study.

Oh studies are adaptive in nature as we learn more about the virus in or antibody cocktail in other studies are being planned as well.

All of these days have passed several safety assessments with no safety concerns observed to date.

Despite the challenging environment in which these days are being conducted we are targeting a report initial virology and biomarker data from the treatment studies by the end of September with clinical outcome data to follow as enrollment progresses.

In June we published two important papers in science honoree antibody cocktail in which we've described the details of how the two antibodies you don't cocktail block the Corona virus Spike protein and importantly highlighted the significance of using an antibody cocktail versus a single antibody approach we show.

Was it the console approach avoided viral escape due to bio mutation.

Which rapidly occurred when using single antibody approaches.

In addition, we have recently generate important data in non human primates, which has been boat posted on bio archives.

These studies showed that in this setting or anybody cocktail can not only effectively prevent infection primates matching or exceeding recently published prevention data achieved with vaccine approaches, but also that our cocktail can treat those already infected by accelerating but elimination.

George D. Yancopoulos: Our potentially pivotal Phase II study continues to enroll globally, and we are having productive discussions with regulators to expand the registrational program with combinations and in earlier lines of treatment. We are preparing to explore novel combinations, including a combination from our novel class of co-stimulatory bispecifics that is one targeting B-cells specifically. We recently published a second major paper featured on the cover of Science Translational Medicine in June, describing how these co-stimulatory bispecifics can synergize not only with CD3 bispecifics but also with PD-1 blockers. Finally, we are actively working on subcutaneous delivery of this potentially important drug candidate. Our BCMA by C3 bi-specific is moving forward, and we are planning to initiate potentially pivotal studies in various multiple myeloma settings. Moreover, we intend to explore standard and novel combinations, including with co-stimulatory bi-specific targeting. Plasmas

The next one highlight the outside support we have received for our strategy. In addition to conducting our phase three prevention study in collaboration with the Eni I'd, which is absolutely expands our reach two investigator cocktail into preventative setting. We recently signed a manufacturing contract with BARDA as part of.

Operation Warp speed to make initial lots of our cocktail at risk. So the drug could be available as soon as possible improving efficacious and approved by the FDA.

Well, we're all hoping that vaccines proves successful we ourselves are partnering on sums novel second generation.

Vaccine approaches.

We believe that our neutralizing antibody cocktail could play an important role as a rapid first line in defense in dose for whom of vaccine is not available.

And in the long term could also provide protection for those lease likely to respond well to a vaccine such as the elderly and immunocompromised mice.

George D. Yancopoulos: We expect to provide updates for both our CD20 and BCNA programs at ASH later this year. I would like to expand a bit on our co-stimulatory bispecific effort as it represents an important example of the ongoing innovation in oncology for Regeneron. As I said, we are planning on combining such co-stims with both our CD20 and BCMA bispec programs for lymphoma and myeloma. But our first co-stimulatory bispecific is already in clinical development. This first-in-human co-stim, PSMA by CD28, is in combination with liptia for prostate cancer and is continuing to enroll in the dose escalation stage of clinical investigation.

Moreover, unlike a vaccine and that's supported by our initial primate studies are cocktail may not only prevent infection, but could also have the potential treat those already infected.

Moving onto our efforts outside of covert 19th and starting with Dupixent.

The demonstrated safety and efficacy of Dupixent or further bolstered by the recent FTC approval in children with moderate to severe atopic dermatitis.

Children as young as six years old and we're not stopping there as we are conducting the study even younger a topic dermatitis patients and for chosen with asthma, we plan to submit a BLE supplement for approval in pediatric as and by the end of the year pending upcoming phase three data.

We're also enhancing convenience for all patients with the recent FDA approval of our 300 milligram auto injector.

Outside of United States Dupixent was approved in China recently, which represents a major milestone as we work to ensure patients everywhere have access to this life changing medicine.

George D. Yancopoulos: We're also excited about two additional Costa and Bi-Pacifics scheduled to enter the clinic this year. These new CoSTIM trials include EGFR by CD28 in combination with Liptayo, which will be explored in several solid tumors, including lung cancer and head and neck cancer, as well as MUX16 by CD28, which will be tested for patients with ovarian cancer as well as in other settings. Our MUX16 co-stim will be studied in combination with either Leptile or our MUX16 by CD3 bispecific, which is already in the clinic.

Our Dupixent clinical program continues to deliver positive results in additional type two inflammatory indications in May we announced that we met the primary in key secondary endpoints in part a of our pivotal trial in the Susan Filyk esophagus.

Patients treated with Dupixent demonstrated significant clinical anatomic improvement with almost a 70% reduction in disease symptoms compared to an approximately 30% reduction for patients on placebo as demonstrated by the Dysphasia symptom questionnaire.

We are currently enrolling part b of this trial and communicating with regulators about filing requirements for the syndication.

In addition, the first pivotal dupixent trial in patients with chronic obstructive pulmonary disease typified by type two inflammation or type to see LPD completed a pre specified analysis by the independent data monitoring committee, requiring a certain threshold reduction in exacerbations, which was.

George D. Yancopoulos: The span of our toolkit enables us to explore these and many new combinations that, based on preclinical evidence, could provide meaningful advances for a wide variety of cancer patients. Moving on from oncology, I would like to provide an update on our Fucinimab program. We have previously announced positive top-line efficacy data in a Ficiniumab Phase III FACT long-term safety study, or FACT LTS sub-study, and today we are announcing that two additional Phase III studies in patients with osteoarthritis pain, FACT OA1 and FACT OA2, met the co-primary efficacy endpoints for the Ficiniumab one milligram monthly dose versus The Facinimab 1 mg monthly dose also showed nominally significant benefits in physical function in both trials and pain in one of the two trials when compared to the maximum FDA-approved doses of NSAIDs for osteoarthritis.

Matt and thus triggered opening a second pivotal trial for this potential indication.

[noise] approval and type Tcl PD would unlock another important opportunity for dupixent to help patients with type two inflammatory disease, who currently have limited options.

Moving onto our oncology portfolio and starting with our PD one antibody lipton, while at the virtual ASCO meeting, we presented a clean equal clinically meaningful cutaneous squamous cell carcinoma data follow up.

Followed by a label update as well as reported ASKO was up to three years, a follow up while the overall response rates remain stable approaching 50%. The complete response rates have climbed to 20% in metastatic see FCC, increasing from the 7% rate reported.

The initial primary announces providing one of the most dramatic examples of ongoing in prolong benefit from an immunotherapy treatment.

Moreover, these data firmly established reptile.

Yes first in class for this dermatology cancer setting with compelling long term clinical data.

George D. Yancopoulos: The less frequent dose of Facinimab, 1 mg every two months, used in an arm of the FACTO-A1 trial, showed a numerical benefit over placebo but did not achieve statistical significance. In initial safety analysis from the Phase 3 trials, there was an increase in arthropathies reported with viciniumab. In the FACT-LTS sub-study, there was an increase in joint replacements with viciniumab 1 mg monthly treatment during the off-drug follow-up period, although this increase was not seen in the other trials to date.

In addition last quarter, we announced positive first in class data for a second term until in college indication that is basal cell carcinoma, which we will be submitting for regulatory review.

Finally, we're excited about the opportunity for the tile in non small cell lung cancer based on our recent positive phase three trial with lip tile as monotherapy in PDL one high patient.

Which will also be submitting for regulatory review and we have completed screening patients for enrollments in our follow on chemo combination study in lung cancer.

Taos foundational to oncology strategy, and we're making significant progress with will tailwind skin cancers lung cancers in are numerous combination and collaborative studies.

George D. Yancopoulos: Additional longer-term safety data from the ongoing trials is being collected and is expected to be reported early next year. Finally, I would like to briefly address other exciting developments in our pipeline. We are planning to publish evanacumab results in homozygous familial hypercholesterolemia shortly, and we have submitted our applications to the FDA and to EMA.

Our cdthree by specific clinical program is moving forward despite operational challenges imposed by the Tobin 19, pandemic Regeneron 1979, or cdtwenty by Cdthree by specific I showed robust efficacy in both follicular lymphoma, and more aggressive disease, including deferred.

These large b cell lymphoma.

George D. Yancopoulos: Regarding our GERITUSIMA program for Fibromyalgia Ospigans Progressiva, or FOP, we are planning to submit data to regulatory authorities in the first quarter of next year, pending results from the crossover arm of our trial, where placebo patients are now receiving active drugs. Our hope is to replicate the dramatic 90% reduction in new lesion formation that we saw in the first part of the trial. At the European Hematology Association meeting in June, we presented promising pozolimab monotherapy interim results in paroxysmal nocturnal hemoglobinuria patients.

Or potentially pivotal phase two study continues to enroll globally and we are having productive discussions with regulators to expand the registrational program with combinations and in earlier lines in June.

We are preparing to explore novel combinations, including a combination.

From our novel class of coast inventory by specifics that is one targeting b cell specifically, we recently published a second major papers featured on the cover of Science translational Medicine in June describing how these coast inventory by specifics can synergize not only will see three by specifics, but also with.

PD one blockers.

Finally, we are actively working on subcutaneous delivery this potentially important drug candidate.

George D. Yancopoulos: We are hoping to start testing ILEA in combination with alnilam's RNA eye treatment, somediserin, by year end. And last but certainly not least, we are starting to enroll our Phase III studies of high-dose ILEA in DME and wet AMD. High-dose ILEA has the potential to reduce dosing frequency while maintaining the efficacy and safety of our medicine that is trusted by doctors and patients worldwide.

Our bcm aimed by C buys Pacific is moving forward and we're planning to initiate potentially pivotal studies in various multiple myeloma settings. Moreover, we intend to explore standard novel combinations, including with the co stimulatory buys Pacific.

Targeting.

Yes muscles.

We expect to provide updates for both our Cdtwenty NBC programs at Ash later this year.

I would like to expand a bit on or co stimulatory by specific effort as it represents an important example of the ongoing innovation in oncology for Regeneron as I said, we're planning on combining such coast ins with both our Cdtwenty in Bcm made by spec programs for lymphoma in myeloma, but our first.

George D. Yancopoulos: To conclude, our broad and diverse pipeline is growing and progressing, even in this COVID-19 environment. I could not be prouder that even in these extraordinary and challenging times, our people are continuing to push on every front in our efforts to bring important new treatments to the patients who need them. I now turn over the call to Marion.

Three by specific is already in clinical development.

First in humans coast in PSS made by Sea East 28 is in combination with live tire for prostate cancer is continuing to enroll in the dose escalation stage of clinical investigation.

Marion McCourt: Thank you, George. Our second quarter business performance reflects the resilience and competitive strength of our corporate. Aaliyah, Detection, and Liberation.

We're also excited about two additional coast in bi specifics scheduled to enter the clinic this year.

These new coast interest include EG F. R. By CD 28 in combination with tile, which will be explored and several solid tumors.

Marion McCourt: We remain confident in our ability to navigate through COVID-19 and position our portfolio for future growth if demand occurs. I'm going to begin with ILEA, which had $1.75 billion in global net sales. In the U.S., ILEA net sales were $1.11 billion, which is just 4% lower than the same quarter last year, despite the impact of COVID-19. Aliyah outperformed the overall anti-veg market in the U.S. with continued share gains from both branded and unbranded. In fact, Ilia's share of the branded U.S. market The Bulletproof Executive 2013, The impact of CO After this, sales improved throughout May and into June as retina specialists reopened offices, and patient volume increased.

Including lung cancer, and head and neck cancer as well as much 16 by CD 28, which will be tested for patients with ovarian cancer as well as another sense are much 16 coast in will be study in combination with either live tire or must 16 by C by specific which is already in the clinic.

The span of our tool kit enables us to explore these and many new combinations that based on preclinical evidence could provide meaningful advances for a wide variety of cancer patients.

Moving on from oncology I would like to provide an update on our personal care program.

We previously announced positive top line efficacy data in assessing he ma'am phase three fact long term safety study or fact, LTL sub study and today, we are announcing that two additional phase three studies in patients with osteoarthritis pain.

Marion McCourt: The combination of three ILEA attributes, differentiated efficacy, safety, and dosing flexibility, is highly valuable in easing physician and patient burdens caused by the pandemic. Physicians may treat with extended dosing of up to 12 weeks in appropriate patients, and the recently launched pre-filled syringe offers additional efficiency for patient care. ILEA demand continues to show steady improvement, and the volume of new patients in the market is approaching pre-pandemic levels. We're closely monitoring the recent resurgence of COVID-19. Under all scenarios, we remain highly committed to supporting the retina community through virtual and in-person platforms to ensure the continuity of patient care. In summary, we're encouraged by the rebound and ILEA demand in recent months, and we will continue to advance efforts to support our customers and their patients during these unprecedented times. Turning next to Liptio, second quarter global net sales grew to $80 million, with the U.S. contributing $63 million. However, in April, patient office visits declined, and some infusion centers temporarily closed.

Backed away, one and fat allay to met the co primary efficacy endpoint for the Cindy Ma'am, one milligram monthly dose versus placebo.

The facility May have one milligram monthly dose also showed nominally significant benefits in physical function in both trials in pain in one of the two trials when compared to the maximum SD eight approved doses of and sets for osteoarthritis the less frequent dosing of the seem to have one milligram every two.

Months used in an arm of the fact away one trial showed numerical benefit over placebo, but did not achieve statistical significance.

Initial safety analysis from in Phase three trials, there was an increase Northrop feeds reported with senior man in the fact LTL sub study there was an increase in joint replacements with rescinding them, one milligram monthly treatment during the off drug follow up period. Although this increase was not seen in the other trials to date.

Additional longer term safety data from the ongoing trials is being collected and is expected to be reported early next year.

Finally, I would like to briefly address other exciting developments in our pipeline, we're planning to publish of enacting map results in homozygous familial hypercholesterolemia shortly and we have submitted our applications to the FDA and EMA.

Marion McCourt: This briefly impacted Liptio demand, which rebounded during May and June. In the U.S., libtio advanced its leadership as the number one systemic treatment for advanced cutaneous squamous cell carcinoma, or CSCC. Libtio has experienced rapid growth in advanced CSCC, with 70% of patients now treated with anti-PD1 therapy. We expect future growth as the Libtio competitive profile strengthens with new long-term data demonstrating longer durability, higher overall responses, and nearly three times the rate of complete responses based on additional years of follow-up. Looking ahead, we are preparing for potential future launches with our collaborator Sanofi in both non-small cell lung cancer and basal cell carcinoma. Both represent meaningful growth opportunities for Libkio.

Regarding our Gare Tulsa program for Fibril dysplasia, Ossificans progressiva or FOP, we're planning to submit data to regulatory authorities in the first quarter of next year pending results from the crossover armor var trial were placebo patients are now receiving active drug.

Hope is to replicate the dramatic 90% reduction in new lesion formation that we saw in the first part of the trial.

The European Hematology Association meeting in June we presented promising position Mab monotherapy interim results in Paris, ASML nocturnal Hema to global urea patients.

We are hoping to start testing in combination with El Nio homes, Arnie I treatment some disappearing.

By year end.

And last but certainly not least we're starting to enroll or phase three studies of high dose I Leah in DMD and wed AMC.

Hi goes earlier has the potential to reduce dosing frequency, while maintaining the efficacy and safety of our medicine that is trusted by doctors and patients worldwide.

To conclude.

Broad and diverse pipeline is growing and progressing even in this covert 19 environment.

Marion McCourt: The anti-PD-1 and PD-L1 market continues to grow at a significant pace with current annual med sales of nearly $25 billion. Non-small cell lung cancer is the largest opportunity within this market, with more than 200,000 new diagnoses of lung cancer in the U.S. each year. Patients, payers, and physicians prefer choice in determining the most appropriate treatment, and should Liptio be approved, it has demonstrated very competitive clinical results to date in the advanced PD-1 positive patient population study. Finally, moving to Depixent, global net sales in the second quarter were $945 million, representing 70% growth compared to the prior year. In the U.S., broad-based growth across all approved indications contributed net sales of $770 million. Following an initial dip in mid-May, new patient starts have increased as physician offices reopened.

I would not be parameter that even in these extraordinary in challenging times. Our people are continuing to push on every front in our efforts to bring important new treatments to the patients who need.

I now turn over the call to Mary.

Thank you Jerry it's our second quarter business performance platform resilience and competitive strength of our core brands.

Okay.

We remain confident in our ability to navigate in 17 and position our portfolio for future growth from all the covers.

I'm going to begin with idea, which have 1.75 below global net sales in the U.S. LTM net sales were 1.11 billion, because just 4% slower than same quarter last year. Despite the impact of Kevin 19.

Outperformed the overall anti VEGF marketing with continued share gains from both branded and unbranded competition.

I lose share of the branded us market reached 73%.

Net sales for the quarter solidifying our leadership position in the intelligent market.

The impact this pivot 19, unless sales or sub predominantly in April after that.

Marion McCourt: Current weekly new patient starts have recovered to approximately 87% of pre-pandemic levels, a sign of robust demand for Dupixent. Dupixent's compelling clinical profile enables the product to thrive, even in the current environment. Dupixent is administered at home and does not require laboratory testing or monitoring to initiate treatment for most new patients.

So let me into Q as retinal specialists, we opened offices and patient volume increased the combination of three Leah attributes differentiated efficacy safety and dosing flexibility are highly valuable and easing physician and patient gardens caused by the pending.

Physicians need treat with extended dosing of up to 12 weeks and appropriate patients and recently launched pre filled syringe offers additional efficiencies for patient care.

Marion McCourt: Importantly, Dupixent is not an immunosuppressant, and we expect the U.S. launch of the 300 mg pre-filled pen in the third quarter, providing additional patient convenience and choice. Acopic dermatitis is its largest indication and remains a significant growth driver.

We have demand continues to show steady improvement and the volume of new patients in the market. Please approaching pre pandemic levels.

We're closely monitoring the recently surgeons have covered 19 under all scenarios, we remain highly committed to supporting retinal community to virtual and in person platforms to ensure the continuity of patient care in summary, we're encouraged by the rebound and I lead demand in recent months and we will continue to advance efforts to support our customer.

Marion McCourt: We continue to expand physician prescribing across both moderate and severe disease. However, to date, only a small percentage of biologic eligible patients have been treated, leaving substantial opportunity for more patients to benefit. Additionally, new long-term data demonstrate sustained efficacy over a three-year period, along with confirmed safety. We also continue to expand into younger populations. The USFDA recently approved Dupixen to treat children aged 6 to 11 years with moderate to severe atopic dermatitis, which impacts approximately 90,000 children in this country. Dupixen is the only biologic medicine approved for this population, and leading launch indicators are very encouraging. Many children suffering with moderate to severe atopic dermatitis are being treated by the same physicians who have extensive clinical experience with their adolescent and adult patients and have great confidence in the Dupixen safety profile.

Ladies and their patients during these unprecedented times.

Turning next to let tile second quarter Global net sales grew to 80 million with US contributing 63 million in April patient office visits decline and 70 Asian centers temporarily closed his briefly impacted on the tire demand, which we now we bounded during may and June in.

Do you estimate tile advanced its leadership as the number one systemic treatment for advanced cutaneous squamous cell carcinoma, Rcs Cc Mattel has experienced rapid growth in advance CCC with 70% patients now treated with anti PD one therapy.

We expect teacher class, Iceland tile deemed the tire competitive profile strengthens with new long term data demonstrating longer durability higher overall responses and nearly three times the weight of complete responses.

On additional years the follow up.

Looking ahead, we are preparing firms potential future launches with our collaborator Sanofi in both non small cell lung cancer and basal cell carcinoma, both represent meaningful growth opportunities from the tail.

Marion McCourt: Dupixent also continues to outperform in asthma, as measured by more new patient initiations over the last year compared to other biologic competitors. We see further opportunities to expand patient awareness of Dupixent through our national DTC campaign, which is underway. Among those already on treatment, COVID-19 has limited impact as patients adhere to their therapies to maintain and improve respiratory function. Finally, we see strong uptake in chronic rhinosynthesitis with nasal polyps.

Anti PD one PDL one market continues to grow at a significant piece with current annual net sales of nearly 25 billion non small cell lung cancers, the largest opportunity within this market with more than 200000, new diagnoses of lung cancer in us each year patients payers and physician.

Preferred choice in determining the most appropriate treatment and should live tile be approved it has demonstrated very competitive clinical results to date in the advanced PD one positive patient population studied.

Marion McCourt: Since approval last year, patients have been initiated on Dipixent regardless of prior surgery. Demand has increased among ENTs and allergists due to the limited availability of elective surgeries in the last quarter. Overall, we see great opportunity for DEPIXENT, which is positioned for significant growth through expanded indications, age groups, and geographies. In closing, our teams and business remain resilient as we execute on our strategy to deliver value for customers and stakeholders. Now I'll turn the call over to Bob.

Finally, moving to Texan level net sales in the second quarter for 945 million, representing 70% growth compared to prior year in the U.S. broad based growth across all approved indications contributed net sales of 770 million. Following an initial Dick in May.

May new patient starts have increased as physician offices reopened current weekly new patient starts have recovered to approximately 87% of pre pandemic levels a sign of robust demand for the extent to take since Q compelling clinical profile enables the product to thrive even in the current.

Environment. It takes in is administered at home and does not require laboratory testing are monitoring to initiate most new patients importantly, dupixent is not an immuno suppressant and we expect the U.S. launch of the 300 milligram pre sell 10 in the third quarter, providing additional patient convenience and choice.

Robert E. Landry: Thank you, Marion. For the second quarter of 2020, Regeneron delivered strong results on both the top and bottom line. Our continued ability to generate this year-over-year growth is an encouraging signal of our diversified growth potential now and beyond COVID-19. For the second quarter, total revenues grew 24% year-over-year to $1.95 billion, driven by higher Sanofi Collaboration revenues as a result of increasing Pixon sales. Additionally, we recorded significant revenues associated with our infectious disease efforts against both Ebola and COVID-19. These revenues are recorded in our Other Revenue line, bringing non-GAAP net income of $854 million.

Atopic dermatitis is to take since largest indication and remains a significant growth driver. We continue to expand physician prescribing across both moderate and severe disease today only a small percentage of biologic eligible patients have been treated leaving substantial opportunity for more patients to benefit.

Additionally, new long term data demonstrate sustained efficacy over three year period, along with confirm safety. We also continue to expand into younger populations USSTC recently printed except to exceed 76 to 11 use with moderate to severe atopic dermatitis, which impacts approximately.

90000 children in this country typically is the only biologic medicine in prison population and leading launch indicators are very encouraging many children suffering with moderate to severe atopic dermatitis are being treated by the scene physicians, who has extensive clinical experience with our adolescent and adult.

Robert E. Landry: Since Marion discussed our U.S. ILEA results, I will start with our Bayer and Sanofi collaboration. Starting with Bayer, ex-US ILEA net product sales, which are reported to us by Bayer, were 641 million, representing a decline of 10% on a reported basis compared to the prior year due to the COVID-19 impact. Total Bayer collaboration revenue was 244 million, of which we recorded 231 million for our share of net profits from ILEA sales outside. Total Sanofi collaboration revenue was $269 million in the second quarter.

Once and have great confidence in the depicts and safety profile.

It takes it also continues to outperform in asthma as measured by more new patient initiations over the last year compared to other biologic competitors, we see further opportunities to expand patient awareness of Dupixent in our national DTC campaign, which is underway.

Among those already on treatment coated 19 has limited impact as patients here to their therapies to maintain and improve respiratory function.

Robert E. Landry: Our share of the profits from the commercialization of non-IO antibodies was $172 million. This compares favorably to profits of $39 million in the prior year period, which was driven by higher revenue, before moving to expense. I will discuss our second quarter 2020 Other Revenue line item, in which we recorded $212 million, up sharply from the $20 million in the prior year period. The primary driver of the year-over-year increase is the recognition of $126 million associated with BARDA for our research in manufacturing efforts for both Ebola and COVID-19. We record R&D reimbursements from BARDA in Other Revenue. Moving on to our expense bases, starting with R&D. Non-GAAP R&D increased 36% year-over-year to 580 million, driven by significant development costs for both our antibody cocktail and Kevzar clinical trials for COVID-19, in addition to higher head count and increased clinical manufacturing activity, a portion of which was reimbursed by BART. Next, non-GAAP SG&A expense increased 19% year-over-year to $301 million.

Finally, we see strong uptake in chronic rhinosinusitis with nasal polyps since approval last year patients have been initiated and excellent regardless of prior surgery demand has increased among NTS analogist with the limited availability of elective surgeries in the last quarter.

Overall, we see great opportunity for to Texas, which is positioned for significant growth through expanded indications age groups and geographies in closing our teams on business remain resilient as we execute on our strategy to deliver value for customers and stakeholders now I'll turn the call to Bob.

Thank you Marion.

For the second quarter 2020, Regeneron delivered strong results on both the top and bottom line. Our continued ability to generate this year over year growth is an encouraging signal of our diversified growth potential now is beyond coded 19 for the second quarter total revenues grew 24% year over year to.

1.95 billion driven by higher Sanofi collaboration revenues as a result of increasing Dupixent sales. Additionally, we recorded significant revenues associated with our infectious disease efforts against both biller encoded 19, these revenues or recorded in our other revenue line.

Non-GAAP diluted net income per share grew 19% year over year to $7 in 16 cents.

Robert E. Landry: The year-over-year increase was driven by the inclusion of prevalent commercialization costs in the U.S., higher contributions to non-profit patient assistance organizations, and higher headcount-related costs. Non-Gap Cost of Collaboration and Contract Manufacturing was $173 million compared to $79 million in the second quarter of 2019. The year-over-year increase is due to manufacturing costs associated with higher Dupixent volumes sold by Sanofi, Ebola production, and Pralulent supply for Sanofi's ex-U.S. market, turning down a tax. The non-GAAP effective tax rate was 0.9% in the second quarter of 2020 compared to 19.1% in the second quarter of 2019.

Non-GAAP net income of 854 million.

Since marine discuss the USA Leo results I will start with our Bayer incentive fee collaborations.

Starting with the Bayer collaboration ex U.S silent net product sales, which are reported to us by Bayer were 641 million, representing a decline of 10% on a reported basis compared to the prior year due to the cobot 19 impact total Bayer collaboration revenue was 244 million of which we will.

4200, 31 million for our share of net profits from a legal sales outside the U.S total Sanofi collaboration revenue was 269 million in the second quarter, our share of the profits from the commercialization of non Io antibodies was 172 million. This compares favorably to profits of 39.

In in the prior year period, which was driven by higher to take some profits before moving to expenses I will discuss our second quarter 2020. Other revenue line item, which we recorded 212 million up sharply from the $20 million in the prior year period. The primary driver of the year over year increases the recognition of 126 million.

Robert E. Landry: The lower tax rate versus last year was primarily due to increased tax benefits associated with stock option exercises in the realization of those benefits earlier in the calendar year compared to prior years. Now, shifting now to cash flow and the balance. Year-to-date, Regeneron generated $1.34 billion in free cash flow. In the quarter, we spent $5 billion to repurchase approximately 9.8 million shares of our common stock as part of Sanofi's sale of substantially all of their equity stake in Regeneron. As Len mentioned, the secondary offerings in repurchase were strategic transactions that provided Regeneron shareholders immediate accretion, removed uncertainty regarding Sanofi's equity position, and is a testament to our confidence in the strength of our business now and in the future. We ended the quarter with cash and marketable securities of $5.7 billion and $1.5 billion in debt financing under a bridge loan related to the Sanofi stake repurchase.

Associated with BARDA for our research in manufacturing efforts for both of bowler encoded 19, we record R&D reimbursements from BARDA in other revenues.

Moving to our expense base and starting with R&D non-GAAP R&D increased 36% year over year to 580 million driven by significant development costs for both our antibody cocktail income ZAR clinical trials for coated 19. In addition to higher headcount increased clinical manufacturing activities, a portion of which will remain.

First by BARDA next non-GAAP EPS, Gina expense increased 19% year over year to 301 million year over year increase was driven by the inclusion of Praluent commercialization costs in the us higher contributions to nonprofit patient assistance organizations in higher headcount related costs.

Non-GAAP cost to collaboration contract manufacturing was 173 million compared to 79 million in the second quarter 2019, the year over year increase is due to manufacturing costs associated with higher depicts in volumes sold by Sanofi.

Robert E. Landry: Now I'd like to spend a few moments discussing the financial outlook for the remainder of the year. We have maintained or lowered the midpoint of our guidance on several expenses. Please refer to our press release and financial disclosures for our entire updated 2020 guidance. Here, I will discuss the guidance items related to our increased efforts in the fight against COVID-19 as we leverage our end-to-end capabilities of drug discovery, development, and manufacturing. We are updating our forecasted 2020 non-GAAP R&D expenses to be in the range of $2.27 to $2.37 billion. For COGS, we are raising our forecast for 2020 non-GAAP expenses to be in the range of $445 to $485 million.

All of production in Praluent supply for Sanofis ex us markets.

Turning now to taxes, the non-GAAP effective tax rate was 0.9%.

In the second quarter of 2020 compared to 19.1% in the second quarter 2019, the lower tax rate versus last year was primarily due to increased tax benefits associated with stock option exercises in the realization of those benefits earlier in the calendar year compared to prior years.

Shifting now to cash flow in the balance sheet year to date Regeneron generated 1.34 billion in free cash flow in the quarter. We spent 5 billion to repurchase approximately 9.8 million shares of our common stock as part of Sanofi sale of substantially order equity stake in Regeneron as Lynn mentioned.

The secondary offering in repurchase were strategic transactions that provided regeneron shareholders immediate accretion removed uncertainty regarding sanofis equity position. It is a testament to our confidence in the strength of our business now and in the future. We ended the quarter with cash and marketable securities of 5.7 billion in 1.5.

Robert E. Landry: The increase in both R&D and cost of goods sold guidance is related primarily to our efforts against COVID-19. For R&D, we anticipate that more than half of the increase to our 2020 R&D guidance will be reimbursed for COVID-19 efforts. Those reimbursements will continue to be recorded in other revenue. We're also providing updated guidance for our tax rate. We anticipate our updated 2020 non-GAAP effective tax guidance to be in the range of 10% to 12%.

Billion in debt financing under bridge loan related to the Sanofi stake repurchase.

Now I'd like to spend a few moments to discuss the financial outlook for the remainder of the year.

We maintained or load the midpoint of our guidance on several expense items. Please refer to our press release in financial disclosures for entire updated 2020 guidance.

Here I will discuss the guidance items related to our increased efforts in the fight against Cobot 19, as we leverage our end to end capabilities of drug discovery development and manufacturing.

Robert E. Landry: In conclusion, Regeneron's business remains healthy, and we continue to deliver strong year-over-year growth despite the global impact of COVID-19. Our strong balance sheet, improved competitive outlook, increasingly diversified commercial portfolio, and robust pipeline position Regeneron very well for sustained long-term growth. Now, with that, I'd like to turn the call back to just say, Thank you, Bob.

We are updating our forecasted 2020, non-GAAP R&D expenses to be in the range of 2.27 to 2.37 billion.

For Cogs, we're raising our forecast for 2020 non-GAAP expenses to be in the range of 445 to 485 million the increase in both R&D and cost of goods sold guidance are related primarily to our efforts against cobot 19 for R&D, we anticipate that more than half of the increased.

Operator: Stephanie, that concludes our prepared remarks. We'd now like to open the call for Q&A. We have several callers in the queue, and to ensure that we're able to address as many questions as possible, we'll address one question from each caller before moving to the next. Please go ahead, Stephanie.

For 2020, R&D guidance will be reimbursed recovered 19 efforts those reimbursements will continue to be recorded in other revenue. We're also providing updated guidance for our tax rate. We anticipate our updated 2020 non-GAAP effective tax guidance to be in the range of 10% to 12%.

Operator: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound.

In conclusion Regenerons business remains healthy we continue to deliver strong year over year growth. Despite the global impact of coded 19, our strong balance sheet improved competitive outlook increasingly diversified commercial portfolio in robust pipeline position regeneron very well.

Operator: Please stand by while we compile the Q&A robot. And your first questions from the line of Terence Flynn with Goldman Sachs. Hi, good morning.

For sustained long term growth.

Now with that I'd like to turn the call back to Justin.

Terence C. Flynn: Thanks for taking the question. And thanks for all your efforts on the COVID front. I just had one on the manufacturing side. I was wondering if you could give us any more detail about your manufacturing costs for the antibodies, or if you could at least confirm that these are well below $100 per gram.

Thank you Bob Stephanie that concludes our prepared remarks, we'd now like to open the call for QNX, we have several callers in the queue and to ensure that we're able to addresses many questions as possible will address one question for me its color before moving to the next please go ahead Stephanie. Thank you as a reminder to ask a question you need to press star one on the telephone.

So with charter question press the pound key please stand by a lot of composite culinary roster.

And your first question from the line of parents land with Goldman Sachs.

Hi, good morning, Thanks for taking the question and thanks for all your efforts on the covert front.

Leonard S. Schleifer: And if you won't answer that question, I was just wondering, Marion, if you have any perspective you can share on the opportunity for Dupixen in China? And specifically, would you guys seek NRDL reimbursement? Thank you. Terence, that's Len.

Yes, I just had one on the manufacturing side was wondering if you can give us any more detail about year, our manufacturing cost for the antibodies or if you could at least confirm that these are well below a $100 per gram.

And if you won't answer that question was just wondering Marianne if any perspective, you can share an opportunity for dupixent in China.

And specifically what are you guys sake, and our Dl reimbursement. Thank you.

Terrence I Atlanta victory can comment on our Cogs.

Marion McCourt: I don't think we can comment on COGS, but Marion can certainly comment on China, and we're really excited about the opportunity. Your next question is from the line of Jeffrey Porges with SVV. Good morning, and thank you very much for taking the questions. Congratulations on the results and all the progress in the quarter. Perhaps a few questions on the COVID program. George, you referred to the animal data and the high dose used, 50 milligrams per kilogram. Question: Is this the dose that you expect to take forward in the pivotal trials for treatment, and how much lower could it be for prophylaxis? And secondly, if that indeed turns out to be the dose, could you give us some indication of the number of courses that you could envisage having supply for this year and next year, given the available capacity now?

But to Marion concerning the comment on.

Right.

So very happy keen on change. Thank you for the question we're really excited.

Now to the opportunity in China, and I'll also remind that Sanofi has fee on responsibility for China.

I'm hearing encouraged by the progress to date and as it relates to specifics on reimbursement I would guide asking ourselves. He colleagues team described that in more detail and as you know a tremendous market opportunity incredible unmet need and remarkable clinical profile and we're really excited about the opportunity.

Your next question from the line of Geoffrey Porges with SVB Leerink.

Good morning, and thank you very much for taking the questions. Congratulations on the results.

Well the progress in the quarter.

Perhaps a few questions on the covered program.

George you referred to the animal sorry.

The hydrous used 50 milligrams per kilogram is just quite a lot of antibodies could you give us a sense of first is that the taught us that you expect to take forward in the clinical trials for treatment and how much lower could it be for prophylaxis.

Jeffrey Porges: Yeah, we've modeled doses and blood levels from the primate studies in order to design our human studies, and so we are hoping and targeting to achieve similar blood levels in humans as we achieve to achieve the relative efficacies in the primate studies. At those levels, we are at the production level where we could be delivering hundreds of thousands of doses per month for the prophylactic dose level, and tens of thousands of doses per month for the treatment levels, assuming they're in those sorts of ranges that we're predicting right now. But, of course, all that is pending the trials and seeing what doses really work; hopefully, some of the doses work, and so forth So there's still a lot to figure out, but those are the levels that we're targeting.

Secondly, if currency turns out to be retailers could you give us an indication of the number of.

Our courses that you could enters its having supply for this year and next year given the available capacity now.

Yes.

Leaves model the doses in the blood levels.

From the Primate studies in order to design, our human studies and so.

We are hoping in targeting achieved similar blood levels in the humans is where we are achieving to achieve.

The relative efficacies in the Primate studies.

At those levels.

We are at the production level that we could be delivering hundreds of thousands of doses per month.

For the prophylactic dose level and tens of thousands of doses per month for the treatment levels, assuming there in those sorts of ranges that were predicting right now but of course, all that is all pending the trials and seeing what dose is really work hopefully some of the doses work and so forth.

George D. Yancopoulos: And those are the numbers of doses that we're anticipating that we can deliver, depending on how all the clinical trials work. Next question, please. Your next question is from the line of Yaron Werber with Cowan. Hi, good morning. This is the DOI for your own rubber.

So there's still a lot to figure out that those are the the the levels that we're targeting and those are the numbers of doses that were anticipating that we could.

Deliver depending on how all the clinical trials workout.

Next question please.

Yaron Werber: Thanks for taking our questions and congratulations on the start of the quarter and good progress. I just have two questions regarding your COVID-19 program. The first question is regarding the durability and safety of your neutralizing antibody. It seems that some other antibody developers are kind of modifying the FC domain of their antibody candidates to either extend the half-life or minimize the FC-mediated toxicity. Can you kind of discuss whether you made any modifications to your candidate?

Our next question some of your on Weber with Cowen.

Hi, Good morning. This is the deal I plan on Walter.

Thanks for taking our credit trends and the congrats on the high acquire any progress I just have a two questions regarding the are occurring and control and that the first question has.

Regarding the durability Anisette tee up jar neutralizing antibodies isnt that some other antibody developers are kind of modifying the.

I think they'll now they're antibody candidates to either extended half life or minimize the extremity toxicity can you kind of discuss if you made any modifications to your attending.

And my second question I think about India Prevention study essential to me that the ongoing phase three studies looking at the preventing infections in hospitals contacts nothing passenger visual I'm just wondering.

George D. Yancopoulos: And my second question is regarding the prevention study. It seems to me that the ongoing phase three study is looking at preventing infections in household contacts of the infected individual. I'm just wondering because the trial design looks more like a post-exporter prophylaxis. I'm just wondering if you can provide any details regarding your plans for the prevention trials. Right. Well, there's a lot of questions sort of in there.

Hi design looks more like post exposure prophylaxis and just wondering you can provide enhancing chosen guarding the plans on the prevention files, either looking at like the peak quarter.

Perfect that's as any other highlights combinations.

George D. Yancopoulos: So one in terms of engineering our antibodies, historically, we've had very good success with achieving very good half-lives, duration, and durability without making modifications, which, as you know, always come with certain risks. So, at least for our first-generation antibodies, based on that historical success, we're going with unmodified antibodies. In terms of the concerns for antibody-dependent enhancement, we have done extensive studies and efforts on that, including with antibodies that we have or have not modified in effect or function, and based on all of our data and all of our results, we are going forward with antibodies, once again, that are not modified, based on the confidence in the data that we've generated with our preclinical experience. Finally, what was the last question?

Right.

Well as lot of question sort of in there.

So one in terms of engineering, our antibodies historically, we've had very good success with achieving very good half lives.

And duration.

And durability without making modifications, which as you know always come with certain risks.

So at least for our first generation and bodies are based on that historical success, we're going with.

On modified in bodies on in terms of the concerns for antibody dependent enhancement.

We have done extensive studies and efforts on that including with.

Antibodies that we have or have not modified effector function.

And based on all of our data and all of our results.

We are going forward with.

Within bodies once again.

That are not modified based on the confidence in the data that we've generated.

George D. Yancopoulos: Oh, the prevention study. Yeah, so some of those patients will have already been exposed, but there will be ongoing exposure as well. So it's going to be both a pre- and a post-exposure prophylaxis effort. And we will be characterizing whether the patient in the household that we're treating has already been exposed in terms of whether they're already infected or not, in our analysis. Next question, Stephanie. Your next question is from the line of Chris Raymond with Piper. Thanks. So just on the ILEA high-dose program, I know from just looking at the CLINTrials.gov website that your larger DME and AMD trials aren't projected to read out until 2022, but there may be a smaller trial, I think Candela, reading out in 2021. So I guess... The question here is, and I know you guys haven't really gotten to data yet, but... Will we get a sense of the feasibility of this approach next year, especially given that there's a higher dose, and you've got to be mindful of inflammation, etc. ?

With our preclinical experience.

[music].

And.

Finally, what was the last question the prevention setting although prevention study yet so so some of those patients will have already been exposed, but there will be ongoing exposure as well so it's going to be both a pre and post exposure prophylaxis effort.

And we will be characterizing whether the patient in the household that we're treating have already been exposed in terms of where they are already infected or not.

In our analysis.

Next question Stephanie.

Your next question is in light of Chris Raymond with Piper Sandler.

Thanks.

So just on me.

Hi dose program I know from just looking at the control stock of website it looks like.

Your larger Jimmy and Andy trials are projected to read out until 2022, but there may be a smaller trial I think candela breeding out in 2021, So I guess.

The question here is I know you guys haven't really guided to data yet but.

Yeah, when we get a sense of the feasibility of this approach next year.

Especially given it's a higher dose and you got to be mindful of inflammation et cetera.

George D. Yancopoulos: But also maybe remind us why you guys never went the route of using a, you know, a half-life extension like a biopolymer. So I'll take the first part; George, you can take the lead. In terms of the date, we really haven't guided it. It depends on, we're sort of trying to do things in parallel, get some phase two data while we're enrolling the phase threes. So we'll just have to see how that comes along. George can comment on the difficulties of biopolymer.

But also maybe remind us why you guys never went the route of using.

Half life extension like a bio Palmer.

Thanks.

So I'll take the first.

And you can make delay in terms of the date for we really haven't guided it depends on.

Just trying to do things in parallel get some phase two data, where we're enrolling the phase threes.

So we'll just have to see how that comes.

Comes along for George can comment on the difficulties biopolymer work.

George D. Yancopoulos: Right. So we have been investing enormously in efforts to extend biopolymer technology and so forth. And as we all know, and as has been demonstrated recently with the problems of a major competitor, Alias sets a very high bar for safety and for efficacy, and particularly from the safety point of view. And in all of our efforts, we have not been satisfied with our biopolymer efforts so far that those modifications meet that high bar, particularly for safety. And so we have been hesitant to move those programs further into the clinic because of the concerns that we found with those approaches when we compared them and tested them in our preclinical settings.

Right. So we have been investing enormously in efforts with bio polymer extension and so forth and as we all know.

Has been demonstrated recently with the problems of of of a major competitor elicits a very high bar.

For safety and for efficacy in particularly from the safety point of view and in all of our efforts we have not been satisfied.

With our bio Palmer efforts that.

Those modifications.

Me that high bar, particularly for safety and so we have been hesitant to move those programs further into the clinic because of the concerns that we found with those approaches.

When we compare them and test them in our preclinical setting.

In terms of the high doses Leah we are hoping that we'll be able to maintain that safety that high safety bar with a high dose I Leah but to extend the dosing as you know right now.

George D. Yancopoulos: In terms of the high-dose cilia, we are hoping that we'll be able to maintain that safety, that high-safety bar with the high-dose cilia. But to extend the dosing, as you know right now, studies show that, depending on the patients, about 50% of the patients can go to Q12 dosing using the current dose of ILEA. And what we're hoping is that we may be able to increase the percentage of those patients who can go to longer-term dosing using this higher dose, but to achieve that in as safe a manner as we have historically with ILEA to date. So that's the basis of our strategy.

Studies show that depending on the patients about 50% of the patients can go to 12 dosing.

Using the current dose of Ilea and what we're hoping is that we may be able to increase the percentage of those patients who can go to longer term dosing using this higher dose the to achieve that in a in as safe.

Manner as we have historically with I leave it to date.

George D. Yancopoulos: Yeah, I just might add that we're not sure there's any evidence that there's a dose-dependent effect on inflammation, at least with... Quality Idea. Next question, Stephanie. Your next question is from the line of Robyn Karnauskas. Hi guys, thank you for taking my question. Good morning.

That's the basis of our strategy, Yeah, I just might add that we're not.

Sure this any evidenced that theres a dose dependent.

Effect on information at least with.

Hi, Qualys lease that we make so much of its.

Certainly going to be the case.

Robyn Kay Shelton Karnauskas: So, question on Sicinema, since you announced your top-line data this morning, can you just give us some sense for the hip and the knee. You talk more broadly about the market, but the hip and the knee, what a monthly dose, what the opportunity might be, given that that would be the profile and your strategy for going after, now that you know what that profile is, going after other joints? Well, I think the biggest concern is obviously having to do with the benefit risk and the safety profile. Obviously, there is an enormous need for alternatives in the pain field, and there are so many tens of millions of people who are living with osteoarthritis pain with limited options and concerns about all the available medications with all the concerns and problems with opiates in particular but also with NSAIDs and so forth.

Next question Stephanie.

Your next question is in the line of Robyn Karnauskas with Julie.

Hi, guys. Thank you for taking my question.

Good morning, So question on Cinemark view, you announce your topline data. This morning, He's just give us some sense in the hip and knee you talk more broadly about the market, but the hip and knee like a monthly dose what the opportunity might be given that that that would be profile and your strategy for going after now that you know what that profile is going up.

Sure other joint.

Thank you.

Well I think the biggest concern is obviously, having to do with the benefit risk and the safety profile.

Obviously, there is enormous need for alternatives in pain fields.

And there are so many tens of millions of people who are living with Aastra osteoarthritis pain with limited options and concerns about all the available medications.

With all the concerns and problems with Opiods in particular, but also entered and so forth. All of these patients are potential candidates for the NGL inhibitors. So we are still awaiting and needing to read out additional safety data from our program and I think it's going to still be determined in terms of the relative.

George D. Yancopoulos: All of these patients are potential candidates for the NGF inhibitor, so we are still awaiting and needing to read out additional safety data from our program. And I think it's going to still be determined in terms of the relative benefit risk as to how important a drug this can be for the so many patients who are in need. Yeah, I know. Robert, I just wanted to say I'm glad to see you've got a new name there, Truist. Sounds good. I don't know if it's the truest, but we like to think Regeneron is the truest.

Benefit risk as to how important.

A drug this can be for this so many patients who are in need here.

Yes.

Robin I just.

I wanted to mention glad to see you have got new name their true sounds good.

I don't know if the truest, we'd like to pick regenerative truest, but at any rate the the notion of of whether that the risk benefit is going to work as George pointed out I mean to some extent where sort of behind the the alliance of.

Leonard S. Schleifer: But at any rate, the notion of whether the risk-benefit is going to work, as George pointed out, I mean, to some extent, we're sort of behind the alliance of Lilly and Pfizer in this class, and they've announced, I think that their action date is December, and they've recently said there's not going to be an advisory panel. So we'll get to see, as we're preparing our dossier and collecting the rest of our data, how the FDA views all this and what constraints or restraints they might put on it or if they will or they won't approve it. So you'll get a little bit of an insight into the class because it does appear that we see the same kinds of adverse events in general. In terms of what's happening... that we saw off the drug, that has been seen with... Great.

Lillian Pfizer in this class.

They've announced the they think that they're action date is December. They recently said, there's not going to be an advisory panel. So we'll get to see as were preparing our file and collecting rest why they will get see how the FDA views all this and what constraints or restraints, they might put or if they will they want to prove it so you'll get a little bit of an insight into the.

Class because it does appear that we see the same kinds of adverse events in general.

In terms of a throughout the season this increase joint replacements.

That we sort of off drug.

That has been seen with the members of the class.

Leonard S. Schleifer: Thanks for the question. Stephanie, next question, please. Thank you. Your next question is in line with Jeff Meacham with Bank of America. Hey, guys. Thanks for the question. I had one on Lemtaio.

Great. Thanks for the question. Stephanie next question. Please. Thank you. Your next question supply of Geoff Meacham with Bank of America.

Hey, guys. Thanks to the question.

I had one on time.

You guys have basal cell and monotherapy as long as.

Jeff Meacham: Obviously, you guys have basal cell and monotherapy lung as label expansion opportunities, but just wanted to characterize, you know, your trends in 2Q today, and maybe your market share is. Do you feel like you're at saturation today, or is there still an opportunity, you know, in your core indication today? Thank you. Sure, so, you know, this is still relatively early in the launch for Liptio. The team has done a great job of establishing Liptio for these patients with locally advanced and metastatic disease with the alternative of Liptio, but certainly, there's significant opportunity to expand our utilization of Liptio and, you know, obviously, as you mentioned, as we potentially get into future indications, even more for Liptio. Yeah, obviously, the big indication where most of the sales in this space are lung cancer, non-small cell lung cancer.

Label expansion opportunities, but just wanted to characterize your.

The the trends in Twoq, you today and maybe your your market share is.

Do you feel like Europe saturation today are still an opportunity.

You know in your in your core indication today. Thank you.

Sure. So this is still relatively early in the launch for Latanya. The teams done a great job of establishing led tile for these patients with locally advanced or metastatic disease with the alternative of love tile.

But certainly there's significant opportunity to expand our utilization and obviously as you mentioned as we potentially get into future indications, even one for let tile.

Yeah, obviously, a big indication of where most of the sales in this space or is lung cancer in non small cell lung cancer and.

So were exciting data, which will be basis of a filing amount of therapy and were.

Jeff Meacham: So our exciting data, which will be the basis of a filing amount of therapy, and we're moving rapidly towards closing out the final patients enrolled in the chemo combination study. So lung cancer is really the bigger future opportunity. And of course, ultimately, as we tried to highlight, it is a little disappointing how the PD-1 class has not had as, dramatic efficacy as one would have wanted in so many other cancer settings and that's why we have our very exciting and innovative collection of bi-specifics and other combination opportunities that now that we have our own PD-1 as a foundational component we can now be trying to increase and add efficacy in all of these other cancer settings where right now the PD-1 class is not really shown as much benefit as one would want that maybe we can now really create enormous benefit in these settings by making the right combinations particularly with our bi-specifics but with other combination opportunities as well. Thanks, Jeff.

Moving rapidly towards closing out the final patients enrolled in the chemo combination study so lung cancer is really big future opportunity.

If we can successfully complete compete there.

And of course ultimately.

As we tried to highlight.

It is a little disappointing how the PD one class has not had as.

Dramatic efficacy as one would have wanted in so many other cancer center settings, and Thats why we have are very exciting and innovative collection of bi specifics and other combination opportunity that now that we have our own PD one as a foundational.

Component, we can now be trying to increase in AD efficacy in all of these other cancer settings, where right now the PD one class is not really shown as much benefit as one.

I would want that maybe we can now.

Really create enormous benefit in these settings by making the right combinations, particularly with our bi specifics, but with other combination opportunities as well.

Thanks, Jeff next questions Stephanie.

Marion McCourt: Next question, Stephanie. Your next question is from the line of Ronnie Gao. Good morning, thank you for taking our questions and congratulations on the nice progress. Back to the COVID-19 cocktail, one question I have is about the hospitalized patient trial, which is how do you monitor patients who mount their own immune responses and kind of confound the data with that?

Next question from the line of Ronny Gal Bernstein.

Good morning, Thank for taking my question and congratulations nice pullbacks back to their code 19 cocktail hour question I have about hospitalization trial, which is how do you monitor against patients mounting don't immune response and kind of confounding did it that way and related and does the release of the.

George D. Yancopoulos: And related, does the release of the biomarker data late summer tell us something about the completion of the efficacy readouts, or is there some relationship there we can follow, or are you going to press release the completion of the enrollment, just to give us an idea of how we know the antibody efficacy data? These are all great questions, and, in fact, we are analyzing our data exactly with regard to some of the points and concerns that you have. We are measuring, among the biomarkers, patients' endogenous response, their antibody titers, and we're comparing and dividing the patients based on their baseline levels of antibody titers to see whether the patients who respond the best are the people who are not progressing or are too early in the course of their disease.

While market data late summer does that tell us something about the completion of the efficacy already read outs or is there. Some relationship that we can follow are they going to press released the completion of enrollment just to give us an idea where how do we know out that antibody has exceeded its coming.

These are all great questions and in fact, we are analyzing data exactly.

With regards to some of the points and concerns that you have we are measuring among the biomarkers were measuring patients in the Dodgers response, there antibody titers, and we're comparing and dividing the patients based on their baseline levels of antibody titers to see whether the patients who respond the bastard the people who.

We are now mounting or or are too early in the course of their disease.

George D. Yancopoulos: And we have this adaptive design. We are going to continue to generate data and evaluate data. We will hopefully be reporting some of that data publicly, but then using that data to make decisions in terms of the adaptive future portions of our design. Next question, please. Your next question is from the line of Tim Anderson with... Thank you. I have a question on Duplix and COPD.

And we have this adaptive design, we are going to continue to.

Generate data and evaluate data, we will hopefully be reporting some that data publicly but then using that data and make decisions in terms of the adaptive future portions of our design.

Okay. Thanks next question please.

Our next question from the line of Tim Anderson with Wolfe Research.

Thank you I've a question on Dupixent.

And fuel PD.

Timothy Minton Anderson: COPD remains a holy grail for asthma biologics, and there have been earlier preliminary COPD data sets with other products that looked good, only to fail in phase three. So I'm wondering if you can put into context the results from the interim look at your COPD trial that you've referenced, or at least whether those go, no-go criteria were the same that other biologics have relied on, or was that Interim Efficacy Bar set higher with DuPaget? Editor of Biologics at the same time, Yeah, I'm not sure that the earlier biologics that you were referring to demonstrated much different data in their Phase 2 and their Phase 3 programs, and the problems were that, at best, they were demonstrating somewhere around a 15% reduction in their exacerbations. And depending on the phase 3 studies, those were on the border of achieving clinical significance, and that's why those programs didn't move forward. So we did not release the details of the bar that we set, but we did say that the bar that we set had to do with exacerbations.

Today remains the Holy Grail for outcome biologics and there have been.

Earlier preliminary fuel PB it.

The data sets with other products that looked good.

Only to fail in phase three.

I'm wondering if you can put into context the results from the interim look at your CRPD trial that you've referenced.

Or at least whether those go no go criteria for the same it that other biologics have relied on or was that interim efficacy bar set higher with dupixent than with competitor biologics at the same stage of development.

Yes.

And im not sure that the earlier biologics that you're referring to demonstrate much different.

Data in their phase two in their phase three programs in the problems where was that at best they were demonstrating somewhere around a 15% reduction in their exacerbations.

And depending on the phase three studies those were on the border of achieving clinical significance and Thats why those programs didn't you forward. So what we did not release the details of the bar that we set that we did say that the bar that we said had to do with exacerbations and we have.

George D. Yancopoulos: And we had to achieve a minimum threshold reduction in exacerbations in order to go forward and initiate the initiation of an additional phase 3. So obviously, the fact that we met a threshold bar for reduction in exacerbations creates some excitement, and assuming that we can continue to achieve these sorts of reductions in exacerbations, this could be an important drug for COPD.

To achieve a minimum threshold reduction in exacerbations in order to trigger going forward and triggering the initiation of an additional phase three so obviously the fact that we met a threshold bar for reduction in exacerbations I think.

Creates.

Some.

Excitement.

That.

Assuming that we can continue to achieve these sorts of reductions in exacerbations that this could be an important drug to see LPD.

Leonard S. Schleifer: Yeah, I just want to echo what George said there because this is a little different than most other sorts of futility analyses where, you know, you say, well, even if you have a slim chance, sometimes you let the trial go forward. As George said, and I'm just really trying to put an exclamation point on it, it was a stringent test that meant that it was hard to pass that bar because, obviously, Sanofi and Regeneron, we didn't want to take on another whole phase three. program, which obviously takes a lot of time, money, and effort.

Great I just want to act as I, just want to Echo what George said it because this is a little different than most other sort of.

Futility analyses, where you say well, even if you have a slim chance you sometimes you let the trial going forward as George said and then just really trying to put up.

Exclamation. It was a search stringent that means that it was hard to pass that bar, because obviously satterfield regeneron, we didn't want to take on another whole phase three.

Program, which is obviously takes a lot of time money in effort.

Unless we were told we didnt see the data we just know that we passed the stringent.

Leonard S. Schleifer: Unless we were told, and we didn't see the data, we just know that we passed this stringent bar. And the bar was for reduction in exacerbations. Next question, please. Your next question is from the line of Yatim Sunja with Guggenheim Park. Hey guys, congrats on all the progress. A question on the commercial front with regard to the cocktail approach that you have, can you comment on how you see adoption in light of the recent data that we are seeing with vaccines given that they provide a little bit longer protection? Is it that the antibody approach has a lower potential to fail versus a vaccine and hence you are almost guaranteed protection?

Pardon.

And the bar was for reduction in exacerbations right.

Next question please.

Your next question from the line of Yachting soon job with Guggenheim partners.

Hey, guys. Congrats on all the progress a question on the commercial front for our with regard to though that the cocktail approach that you have can you can you comment on how do you see the adoption in light of depletion data that we are seeing with vaccine given that they provide a little bit longer protection is is that the antibody approach has a lower potential.

To fair or should the vaccine or.

And enhance you are almost guaranteed that protection.

Yatim Sunja: Maybe, perhaps, if you can talk about how the market will play out once you have the vaccine available. I wasn't sure whether there were two parts to that question, whether there was some insight into the technical aspect, or whether George understood that. I'm not going to get into that, but from the commercial side... I've said for a long time that passive immunization with an antibody cocktail provides immediate immunity, so in the setting of, until there's a vaccine, if this comes first, that would be great, but even after there's a vaccine, there will be many people who are not vaccinated or whose vaccination effects wear off, and they get ill, or if they were vaccinated, they didn't get enough

Maybe perhaps if you can talk about how the market plays out once you have vaccine available. Thank you.

I wasn't sure whether there was two parts of the question whether some insight on the technical aspect if Georgians today, he can instantly answer that but from the commercial side.

I think it's what's been said for a long time this.

A passive immunization with an antibody cocktail provides immediate immunity. So in this setting up until this vaccine. If this comes first that would be great, but even after this vaccine there'll be many people who are not vaccinated Oahu specs and nation effects war, often they got ill.

Or if they were vaccinated they didnt get enough of a response.

Leonard S. Schleifer: So we think there's a lot of places for this passive immunization with an antibody. George, I'm not sure what it was. Follow that. Yeah, I think that you got it. Yeah. Thanks, John. Next question, please. Our next question is from the line of Althea Young.

So we think there's a lot of places for this.

Passive immunization with an antibody cocktail George on the true was there to follow that have a pointer.

No I think that you've got it.

Thanks next question please.

Your next question from the line Althea young with Cantor.

George D. Yancopoulos: Hey guys, thanks for taking my question. And I was just kind of curious about what's going on with Evacenumab for the AngPTL-3 program. I know that you're filing, but I thought it was a relatively kind of small market opportunity, but I just wanted to kind of think about that and what the potential extension opportunities from there are. Thanks. Yeah, this is Ang PTL-3. You said epinacumab. It was a little hard to hear. Yeah, oh, sorry. Yeah, but yeah, I think I've got it.

Hey, guys. Thanks for taking my.

A question and I was just kind of curious about what's going on with Actavis element for the as detailed three program I know that you're filing, but I thought it with a relatively small market opportunity, but just wanted to kind of think about that and what are the potential extension opportunities from there. Thanks.

Yes. This is evidenced Pts three you said have enactment was little hard to here, Yeah, Oh, sorry, yeah, but yes, I think I think I guided commercial potential and life beyond that indication as well.

George D. Yancopoulos: Commercial potential and life beyond that indication as well, right? We think this is a very important proof of concept setting. If we get it approved, as you said, it's for homozygous FH, it's for a very rare genetic population, and particularly what we showed was efficacy in patients who have no LDL receptor function. So that means that this drug and this pathway work totally differently than all other drugs that lower lipids and cholesterol.

Right. We think this is a very important proof of concept setting.

These are if we get approved as you said it is it's for homozygous FH, it's for a very rare genetic population.

And particularly what we showed was efficacy in patients who have no LDL receptor function. So that means that this drug.

And this pathway work totally different than all other drugs that lower lip isn't cholesterol.

And it may have important growth opportunities. After this in the sense that.

George D. Yancopoulos: And it may have important growth opportunities after this in the sense that since it lowers lipids, not only cholesterol, but triglycerides by these independent mechanisms, it is entirely possible, and we are thinking about it, about whether there's a broader opportunity for this class of drug in the future. But we're also very excited about the near-term opportunity that we hope we'll get agreement from the FDA shortly in the homozygous FH population, particularly those who don't respond to any of the existing drugs. And I'll add just one thing. You mentioned the size of the population. This is a rare condition, and in the U.S., there's a population of patients, about 1,300, who would be eligible candidates that we feel we'd have an opportunity to help very significantly with this rare and challenging disease. Ex-U.S., it's about 1,700.

Since it is lowering lipids not only cholesterol, but triglycerides.

By these independent mechanisms.

It is entirely possible and we are thinking about it about whether there's a broader opportunity eventually for this class of drugs.

But we're also very excited about the near term opportunity that we hope we're going to get.

Agreement were from the FDA shortly in the homozygous FH population, particularly those who don't respond to any of the existing drugs and in all I. Just you mentioned size of the population.

The it this is a rare condition and in the U.S. Theres a population of patients about 1300 will be eligible candidates.

We feel we'd have an opportunity to help very significantly with is somewhere in challenging disease ex us it's about 1700.

George D. Yancopoulos: I think we have time for one more question, Stephanie. Thank you. Your final question will come from the line of Evan Seigerman. Thanks for squeezing me in there at the end. Looking at the antibody data in September, would that be, assuming it's positive, enough to get an EUA from the FDA? And if not, what else do you need to generate and when could we see that data?

I think where time for one more question Stephanie.

Thank you. Your final question comes the line of Evan Seigerman with credit Suisse.

Thanks for squeezing me in there at the end.

Looking at that antibody data in September with that be assuming that positive that enough to get and eating away from the FDA and if not what else do you need to generate and when could we see that data. Thank you.

George D. Yancopoulos: Thank you. Well, it'll all depend on the data and how good it looks. So there are so many variables that I think it's really impossible to give a fair answer to that question.

Well it all depends it will all depend on the data and how good it looks so there's so many variables that I think it's really impossible to give a fair answer that question.

Evan Seigerman: Okay, thanks. Thanks, Evan. Thanks for everybody dialing in. This concludes our call. Bob Landry and the IR team will be available after the call to answer further questions.

Okay. Thanks.

Thanks, Evan Thanks for everybody dialing in this concludes our call Bob Landry in the IR team will be available after the call answer further questions stay well unsafe everyone. Thank you very much.

Operator: Stay well and safe, everyone. Thank you very much. Thank you. This does conclude today's conference call. You may now...

Thank you. This does conclude today's conference call you may now disconnect.