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 Please be advised, today's call is being recorded. Thank you. Justin Hocko, 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 Doctor.
Leonard Schleifer, Founder, President and Chief Executive Officer Doctor. Georges Jankopoulos, 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 And 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 forecast and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement issues in 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. 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 10Q for the quarterly period ended June 30, 2020, which has been filed with the SEC 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, acceleration of those measures to GAAP is available in our financial results press release, which can be accessed on our website. Once our call concludes, Bob Landry and the IR team will be available to answer further questions.
With that, let me turn the call over to our President and Chief Executive Officer, Doctor. Len Schleifer.
Thank you, Justin, and thanks to everyone for joining pandemic conditions. And even on top of that, in Northeast, some power disruption from the storm. But business continues. We had an event for 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-nineteen 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 in our fight against COVID 19 with our novel antibody cocktail. Regeneron continues to execute well in this unprecedented time $5,000,000,000 in the second quarter, a modest decline of 6% compared to the prior year. In the U S, we generated sales of $1,110,000,000 with a pronounced and sustained rebound in demand in May June following the decline in sales we experienced in early April. This rebound The efficacy, safety and convenience of Eylea have proven to be even more viable in the world of COVID-nineteen. As you'll hear from Marion, Eylea outperformed the broader anti VEGF class this quarter.
Demand for Dupixent also proved to be robust in the 2nd quarter with global sales growth of 70% compared to last year. Sales were nearly $1,000,000,000 on continued market penetration in atopic dermatitis, asthma, and new launches. Adding to the Dupixent momentum, 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 symptom further exemplifying the potential of Dupixent to bend the arc of certain type 2 inflammatory diseases. We look forward to additional Dupixent milestones, including an upcoming phase 3 readout in pediatric asthma and enrollment of a second phase 3 study in chronic obstructive pulmonary disease.
We and our patients 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 our partner Sanofi. In oncology, Libtayo is the leading systemic treatment for cutaneous squamous cell carcinoma. We are seeking approvals in basal cell carcinoma and non small cell lung cancer with regulatory filings to be submitted imminent With our chemotherapy combination study in non small cell lung cancer nearing full enrollment, our excitement for Libtayo continues to grow. Beyond Libtayo, we are broadening and advancing our bispecifics portfolio generating further momentum for our oncology strategy. Turning to our efforts to fight COVID 19, we are advancing the development of a novel antibody cocktail known as REGN COV-two that may both treat and prevent infection from the SARS CoV-two 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 also signed 2 major agreements in recent weeks. We announced a $450,000,000 agreement with BARDA and the U. S. Department of Defense to manufacture REGN Cove 2.
We also signed a 6 year $345,000,000 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 Finally, on the corporate front, we contemplate the excuse me, we completed a large secondary offering of more than 13,000,000 shares of our common stock held by Sanofi. Using our strong balance sheet, we also repurchased $5,000,000,000 or 9,800,000 shares from Sanofi, effectively eliminating their ownership position in our company and demonstrating our confidence in the trajectory of our and removed a significant overhang related to the expiration of Sanofi's LICA period at the end of this year. Regeneron is a business that is indeed firing on all cylinders. We thank all of our colleagues across the company who have been working 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 COVID 19 and emerge from the pandemic to drive continued long term growth. Now I'll turn the call over to George.
Thank you, Lynn. And with all of us still in the throes of the COVID-nineteen 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 Ebola program, our new non human primate data for our COVID-nineteen cocktail. As well as our understanding We initiated our clinical program in June, barely 5 months after we started this treatment, developing this treatment. Our rapid timeline was possible due to our Velocity Suite Technologies, which were developed in house over decades to allow for specific turnkey disease interventions and we recently applied to develop our similar approach against Ebola, which we hope will prove to be the 1st treatment approved for this disease with duFA date in October.
We are currently conducting 4 trials of Regeneron COV-two, our antibody cocktail. 1 in hospitalized COVID-nineteen patients, a second ambulatory study in outpatients who are diagnosed with COVID-nineteen, A third, preventative study in household contacts of COVID-nineteen patients being carried out in collaboration with the National Institute of Allogene Infectious Disease and a 4th, multi dose, healthy volunteer study. Our studies are adaptive in nature as we learn more about the virus in our antibody COC 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 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 2 important papers in science. On our antibody cocktail in which we describe the details of how the 2 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 occurred when using single antibody approaches. Which has been posted on bio archives. These studies showed that in this setting, our antibody 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 I next want to highlight the appetite 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, the proven efficacious and approved by the FDA. While 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 in defense in those for Luma vaccine is not available.
And in the long term, could also provide protection for those least likely to spun well to a vaccine, such as the elderly and immunocompromised. 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-nineteen and starting with Dupixent. The demonstrated safety and efficacy of Dupixent are further bolstered by the recent FDA approval in children with moderate to severe atopic dermatitis. Children as young as six years old, 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 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, 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. Our Dupixent clinical program continues to deliver positive results in additional Type 2 inflammatory indications.
In May, we announced that we met primary and key secondary endpoints in Part A of our pivotal trial in the 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 Dupixent trial in patients with chronic obstructive pulmonary disease to provide by type 2 inflammation or Type II 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 pivotal trial for this potential indication. Approval in Type II COPD would unlock another important opportunity for Dupixent to help patients with Type II inflammatory disease who currently have limited options.
Moving on to our oncology portfolio and starting with our PD-one antibody Libtayo. At the virtual ASCO meeting, we presented a clinically meaningful cutaneous squamous cell carcinoma data follow-up, followed by a label update as well. As reported at ASCO was up to 3 years of follow-up, while the overall response rates remained stable approaching 50% the complete report 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 established Libtayo as 1st in class for this dermatology cancer setting, with compelling long term clinical data. In addition, last quarter, we announced positive 1st in class data for a second dermatology indication.
That is basal cell carcinoma, which we will be submitting for regulatory review. Finally, we're excited about the opportunity for Libtayo in non small cell lung cancer based on our recent positive phase 3 trial with Libtayo 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. Libtayo is foundational to our oncology strategy and we're making significant progress with Libtayo and skin cancers, lung cancers and our numerous combination and collaborative studies. Our CD3 bispecifics clinical program is moving forward despite operational challenges imposed by the COVID-nineteen pandemic.
Regeneron1979, our CD20xCD3 bispecifics has shown robust efficacy in both follicular lymphoma and more aggressive diseases including diffuse large B cell lymphoma. Our potentially pivotal phase 2 study continues to enroll globally, 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 costimulatory bispecifics, that is one targeting B cell specifically. We recently published a second major paper featured on the cover of science translational medicine in June, describing how these cost inventory bispecifics can synergize not only with CD3 bispecifics, but also with PD-one blockers. Finally, we are actively working on subcutaneous delivery of this potentially important drug candidate.
Our BCMA by CD3 bispecific 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 a co stimulatory bispecific targeting plasma cells. We expect to provide updates for both our CD20 and BCMA programs at ASH later this year. I would like to expand a bit on our costimulatory 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 bispek programs for lymphoma and myeloma.
But our first cost inventory bispecific is already in clinical development. This first in human's cost in PSMA by CDD28 is in combination with Libtayo for prostate cancer and is continuing to enroll in the dose escalation stage of clinical investigation. We're also excited about 2 additional cost and bispecifics scheduled to enter the clinic this year. These new Coastin trials include EGFR by CD28 in combination with Libtayo, will be 16 by CD28, which will be tested for patients with ovarian cancer, as well as in other settings. Our MUC16 cost in will be studied in combination with either Libtayo or our MUC16xCD3 bispecific, which is already in the clinic.
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. I would like to provide an update on our Fasinumab program. We previously announced positive top line efficacy data in a Vicinimab Phase III fact long term safety study or fact LTS substudy. And today, we are announcing that 2 additional Phase III studies in patients with osteoarthritis pain: FACT OA1 and FACT OA2 met the co primary efficacy endpoints for the fasinumab 1 milligram monthly dose versus Placebo. The fasinumab 1 milligram monthly dose also showed nominally significant benefits in physical function in both trials and pain in 1 of the 2 trials.
When compared to the The less frequent dose of fasinumab 1 milligram every 2 months used in an arm of the FACT OA-one trial showed numerical benefit over Placebo, but did not achieve statistical significance. In initial safety analysis from the Phase III trials, There was an increase in ourthropathies reported with Vicinumab. In the fact LTS sub study, there was an increase in joint replacement with Vicinumab 1 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 cholesterolemia shortly, and we have submitted our applications to the FDA and to EMA.
Regarding our GARITASINDA program for fibroldiplasia, ossvaganz 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 drug. Our hope is to replicate the dramatic 90% reduction in new lesion formation that we saw in the monotherapy interim results in paroxysmal Nocturnal hema to globinuria patients. We are hoping to start testing a combination with Alnylam's RNAi treatment, some disintering by year end.
And last, but certainly not least, we are starting to enroll our phase 3 studies of high dose EYLEA in DME and wet AMD. Igose Eylea 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, our broad and diverse pipeline is growing and progressing even in this COVID-nineteen 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 core brands, Eylea Dupixent and Libtayo. We remain confident in our ability to navigate through COVID-nineteen and position our portfolio for future growth as demand recovers I'm going to begin with Eylea, which had $1,750,000,000 in global net sales. In the U. S, Eylea net sales were one point $11,000,000,000, which is just 4% slower than the same quarter last year despite the impact of COVID-nineteen.
EYLEA outperformed the overall anti vegic market in the U. S, with continued share gains from both branded and unbranded competition. In fact, Eylea's share of the branded U. S. Market reached 73% of net sales for the quarter solidifying our leadership position in the anti VEGF market.
The impact of COVID 19 on U. S. Sales was sold predominantly in April, After this, sales improved throughout May into June as retina specialist reopened offices and patient volume increased. The combination of 3 EYLEA attributes, differentiated efficacy, safety and dosing flexibility are highly valuable in easing physician and patient burdens caused by the pandemic physicians may treat with extended dosing of up to 12 week in appropriate patients and the recently launched prefilled syringe offers additional efficiencies for patient care. EYLEA 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-nineteen. 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 in EYLEA demand in recent months and we will continue to advance efforts to support our Turning next to Libtayo, 2nd quarter global net sales grew to $80,000,000 with the U. S. Contributing $63,000,000 In April, patient office visits declined and some infusion centers temporarily closed, this briefly impacted Libtayo demand, which rebounded during May June.
In the U. S, Libtayo advanced its leadership as the number one systemic treatment for advanced gutaneous squamous cell carcinoma or CSCC. Libtayo has experienced rapid growth in advanced CSCC with 70% of patients now treated with anti PD-one therapy. We expect future growth as Libtayo as Z Libtayo 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 Libtayo. The anti PD-one and PD L1 market continues to grow and a significant piece with current annual net sales of nearly $25,000,000,000. 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 Libtayo be approved, it has demonstrated very competitive clinical results to date in the advanced PD-one positive patient population studied Finally, moving to Dupixent, Global Net sales in the 2nd quarter were $945,000,000, representing 70% growth compared to prior year. In the U. S, broad based growth across all approved indications contributed net sales of $770,000,000. Following an initial dip in mid 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.
Dupixent's compelling clinical profile enables the product to thrive, even in the current environment. Dupixent is administered at home and does not require lab testing or monitoring to initiate most new patients. Importantly, Dupixent is not an immunosuppressant and we expect the U. S. Launch of the 300 milligram pre filled pen in the 3rd quarter providing additional patient convenience and choice.
Atopic dermatitis is Dupixent's largest indication and remains a significant growth driver. We continue to expand physician for describing across both moderate and severe disease. 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 3 year period, along with confirmed safety. We also continue to expand into younger populations.
The US FDA recently approved Dupixent to treat Children need 6 to 11 years with moderate to severe atopic dermatitis, which impacts approximately 90,000 children in this country. Dupixent 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 adolescents and adult patients and have great confidence in the Dupixent safety profile. 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 in our national DTC campaign, which is underway.
Among those already on treatment, COVID-nineteen has limited impact as Finally, we see strong uptake in chronic rhinosinusitis with nasal polyps since approval last year, patients have been initiated on Dupixent regardless prior surgery, demand has increased among ENTs and allergists with the limited availability of elective surgeries in the last quarter. Overall, we see great opportunity for Dupixent, 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 to Bob.
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 $1,950,000,000, 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 Ebola and COVID-nineteen These revenues are recorded in our other revenue line. Non GAAP diluted net income per year over year to $7.16 on non GAAP net income of 854,000,000 Since Marion discussed our U.
S. Eylea results, I will start with our Bayer and Sanofi collaborations. Starting with the Bayer collaboration, ex U. S. EYLEA net product sales, which are reported to us by Bayer, were 641,000,000 representing a decline of 10% was $244,000,000, of which we recorded $231,000,000 for our share of net profits from Eylea sales outside the U.
S. Total Sanofi collaboration revenue was $269,000,000 in the second quarter. Our share of the profits from the commercialization of non IO antibodies was $172,000,000. This compares favorably to profits of $39,000,000 in the prior year period, which was driven by higher Dupixent profits. Before moving to expenses, I will discuss our second quarter 2020 other revenue line item in which we recorded 212,000,000 up sharply from the $20,000,000 in the prior year period.
The primary driver of the year over year increases the recognition of $126,000,000 associated with BARDA for our research the percent year over year to $580,000,000, driven by significant development costs for both our antibody cocktail in Kevzara clinical trials for COVID-nineteen, in addition to higher headcount and increased clinical manufacturing activities, a portion of which were reimbursed by BARDA. Next, non GAAP SG and A expense increased 19 percent year over year to $301,000,000. The year over year increase was driven by the inclusion of Praluent commercialization costs in the U. S, higher contributions to nonprofit patient assistance organizations and higher headcount related costs. Non GAAP Cost of collaboration and contract manufacturing was $173,000,000 compared to $79,000,000 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 in Praluent supply for Sanofi's ex U.
S. 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 of 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 and the balance sheet.
Year to date Regeneron generated $1,340,000,000 in free cash flow. In the quarter, we spent 5,000,000,000 to repurchase approximately 9,800,000 shares of our common stock as part of Sanofi sale of substantially all of their equity stake in Regeneron. As Len mentioned, The secondary offering 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 $5,700,000,000 $1,500,000,000 in 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 lowered the midpoint of our guidance on several expense items. 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-nineteen as we leverage our end to end capabilities of drug discovery development and manufacturing. We are updating our forecasted 2020 non GAAP R and D expenses to be in the range of $2,270,000,000 expenses to be in the range of $445,000,000 to $485,000,000. The increase in both R and D and cost of goods sold guidance are related primarily to our efforts against COVID-nineteen.
For R and D, we anticipate that more than half of the increased 2020 R and D guidance will be reimbursed for COVID-nineteen efforts. Those reimbursements will continue to be recorded in other revenue. We're also providing updated guidance for our tax to 12%. In conclusion, Regeneron's business remains healthy and we continue to deliver strong year over year growth despite the global impact of COVID-nineteen. 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 Justin.
Thank you, Bob. Stephanie, that concludes our prepared remarks. We'd now like to open the call for Q and 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.
And your first question is from the line of Terence Flynn with Goldman Sachs.
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 can 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 any perspective you can share on the opportunity for Dupixent in China, And specifically, would you guys seek NRDL reimbursement? Thank you.
Tim, it's Lynn. I don't think we can comment on COGS, but Marion can certainly comment on China.
Sure. Very happy to, Terence. Thank you for the question. We're really excited, about the opportunity in China. And I'll also remind that Sanofi has the responsibility for China We're very encouraged by the progress to date.
And as it relates to specifics on reimbursement, I would guide 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 SVB Leerink.
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 is just quite a lot of antibody. Could you give us a sense of, first, 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.
Yes. 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 the humans as we're achieving to achieve the relative, efficacies in the primate studies. At those levels, we are at the production level that we could be delivering 100 of 1000 of doses per month, for the prophylactic dose level and tens of 1000 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 all pending the trials and seeing what doses really work.
Hopefully, some of the doses were, and so forth. So there's still a lot to figure out that those are the levels that we're targeting and those are the numbers of doses that we're anticipating that we could deliver, depending on how all the clinical trials work out.
Next question is from the line of Yaron Werber with Cowen.
Hi, good morning. This is Alio I on for Yaron Werber. Thanks for taking our questions and congrats on the side of the quarter and good progress. I just have two questions regarding your COVID-nineteen for the first question is regarding the durability and the safety of your neutralizing antibodies, it seems that some other antibody developers are modifying the efficacy demand of their antibody candidates to either extend the half life or minimize the efficacy mediated toxicity. Can you kind of discuss if you made any modifications to your candidates?
And my second question is regarding the prevention study. It seems to me that the ongoing Phase III study is looking at the preventing infections in household contacts of the infected individual. I'm just wondering because the trial design looks more like a post exposure prophylaxis. I'm just wondering if you can provide any details regarding your plans on the prevention trials, are you looking at like the pre exposure prophylaxis in other high risk populations?
Right. Well, there's a 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, and duration. And durability without making modifications, which, as you know, always come with certain risks So at least for our 1st 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 effector function. And based on all of our data and all of our results, we are going forward with with antibodies once again, that are not modified based on the confidence and the data that we've generated. With our preclinical experience. And Finally, what was the last question? The prevention study.
Oh, the prevention study. Yes. 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 And we will be characterizing whether the patient in the household that we're treating have 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 Center.
Thanks. So just on Aylea high dose program. I know from just looking at the controls dot gov website, it looks like your larger DME and AMD trials are 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 guided to data yet, but will we get a sense of the feasibility of this approach next year in, especially given that there's a higher dose and you got to be mindful of inflammation, etcetera. But also maybe remind us why you guys never went the route of using a half life extension like a biopolymer?
Thanks.
So I'll take the first part, but George, you can make in terms of the date for we really haven't guided. It depends on we're sort of trying to do things in parallel, get some phase 2 data while we're enrolling the phase 3s. So we'll just have to see how that comes along. George can comment on the difficulties of biopolymer work.
Right. So we have been investing enormously in efforts with biopolymer extension and so forth. And as we all know, and has been demonstrated recently with the problems of a major competitor. At least it's 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 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 compare them and test them in our preclinical setting. In terms of the high dose EYLEA, we are hoping that we'll be able to maintain that safety the high safety bar with a high dose EYLEA. 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 212 dosing, using the current dose of EYLEA. And what we're hoping is that we may be able to increase the percentage of those patients who can go to longer in as safe, a manner as we have historically with Eylea to date. So that's the base of our strategy.
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 a high quality Eylea that we make. So I'm not sure that's necessarily going to be the case.
Next question, Stephanie.
Your next question is from the line of Robin Karnauskas with Tuus.
Hi, guys. Thank you for taking my question. And good morning. So, question on cecinumab, since you announced your top line data this morning, Can you just give us some sense in the hip and the knee? You talk more broadly about the market, but the hip and the knee, what a monthly dose, what the offer to me might be given that that would be profile and your strategy for going after now that you know what that profile is going after other joints.
Thank you.
Well, I think the biggest concern is obviously having to do with the benefit risk and the safety profile. Obviously, there's 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. All of these patients are potential candidates for the NGF 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 a drug this can be for the so many patients who are in need here.
Robin, I just wanted to mention glad to see you've got a new name there. Truist sounds good. I don't know if it's the truest, we'd like to think Regeneron the truest. 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 Lillian Pfizer in this class, and they've announced that I think that their action date is December. They recently said there's not gonna be an advisory panel.
So we'll get to see, as we're preparing our file and collecting rest of the day, we'll get to see how the FDA views all this. And what constraints or restraints they might put 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 kind of adverse events in general, in terms of our therapies and these increased joint replacements, that we saw 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 is from the line of Geoff Meacham with Bank of America.
Headwater and Libtayo, obviously you guys have basal cell and monotherapy along as label expansion opportunities, but just wanted to characterize your the 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 in your core indication today? Thank you.
Sure. So this is still relatively early in the launch for Libtayo. The team has done a great job of establishing Libtayo for these patients with locally advanced and metastatic disease with the alternative of Ohio. But certainly there's significant opportunity to expand our utilization. And obviously, as you mentioned, as we potentially get into indications even more for Libtayo?
Yes, obviously, the big indication of where most of the sales in this space are is lung cancer, non small cell lung cancer. And you saw our exciting data, which will be 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 big future opportunity, if we can successfully 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 settings. And that's why we have our very exciting and innovative collection of bispecifics and other combination opportunities that now that we have our own PD-one 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-one class is not really shown as much benefit is one benefit in these settings by making the right combinations, particularly with our bispecifics but with other combination opportunities as well.
Thanks, Jeff. Next question, Stephanie.
Your next question is from the line of Ronny Gal with Bernstein.
Good morning. Thank you for taking my questions and congratulations on nice progress. Back to the COVID-nineteen cocktail. One question I have is about the hospitalization trial, which is how do you monitor, against patients mounting during immune response? And kind of confounding the data that way.
And related, does the release of the biomarker data late summer, does that 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 how do we know the antibody efficacy data is 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 We're measuring 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 or the people who are not mounting 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 and make decisions in terms of the adaptive future portions of our design.
Thanks. Next question please.
Your next question is from the line of Tim Anderson with Wolfe Research.
Thank you. I have a question on Dupixent and COPD. COPD remains a Holy Grail for Aspen Biologics and their been earlier preliminary COPD at COPD data sets with other products that looked good only to fail in phase 3. 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 bars at higher with Dupixent than with competitor biologics at the same stage of development?
I'm not sure that the earlier biologics that you're referring to demonstrated much different data in their Phase II and their Phase III programs. And the problems were, was that at best, they were demonstrating somewhere around a 15% reduction in their exacerbations. And depending on the Phase III studies, Those were on the border of achieving clinical significance and that's why those programs didn't 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 set had to do with exacerbations. And we had to achieve a minimum threshold reduction in exacerbations in order to trigger going forward and triggering the initiation of an additional phase 3.
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 for COPD.
I just want to echo what George said this is a little different than most other sort of futility analyses where 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 it was a stringent that means it was hard to pass that bar because obviously Sanofi and Regeneron, we didn't want to take on another whole phase 3 program, which is 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, if you will.
And the bar was for reduction in exacerbations. Right.
Next question please.
Your next question is from the line of Yatin Sunja with Guggenheim Partners.
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 do you see the adoption in light of the recent 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 to fail versus a vaccine or and hence you are almost guaranteed at protection? 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 to that question, whether there's some insight on the technical aspect, if George understood that, he can certainly 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 the setting of a until there's a vaccine, if this comes first, that would be great. But even after there's a vaccine, there'll be many people who are not vaccinated or who's vaccination effects wore off and they got ill or if they were vaccinated, they didn't 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, did you follow that other point? Or
No, I think that you got it. Yes.
Thanks, Sean. Next question, please.
Your next question is from the line of Althia Young with Cantor.
Hey guys, thanks for taking my question. And I was just kind of curious about what's going on with Evosinimab for the ANGPTL3 program? I know that you're filing, but I thought it was a relatively kind of small market opportunity, but just wanted to think about that and what are the potential extension opportunities from there? Thanks.
Yes, this is ANGPTL3 you said as an acumab. It was a little hard to hear. Yes.
Oh, sorry.
Yes. But yeah, I think I think I got it.
Commercial potential and life beyond that indication as well.
Right. We think this is a very important proof of concept setting. These are, 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 different than all other drugs that lower lipids and 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 drug. But we're also very excited about the near term that we hope we're going to get, agreement.
We're 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 you mentioned size of the population. The this is a rare condition. And in the U. S, there's a population of patients about 1300 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 1700.
I think we have time for one more question, Stephanie.
Thank you. Your final question will come from the line of Evan Sigerman with Credit Suisse.
Thanks for squeezing me in there at the end. Looking at that antibody data in September, would that be assuming it's positive, is that 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? Well, it'll 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 fair answer to that question.
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, answer further questions. Stay well and safe, everyone.
Thank you very much.
Thank you. This does conclude today's conference call. You may now disconnect.