Ladies and gentlemen, thank you for standing by, and welcome to the Regeneron Pharmaceuticals Third Quarter 2020 Earnings Call. At this time, all I would now like to hand the conference over to your speaker, Justin Hulco. Please go ahead, sir.
Thank you, Deborah. 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 third quarter 2020 conference call. An archive of this webcast will be available on our website. Joining me on the call today are Doctor.
Leonard Schleifer, Founder, President and Chief Executive Officer Doctor. George Eankopoulos, Co Founder, President and Chief Scientific Officer Marion McCourt, Senior Vice President And Head of Commercial and Bob Landry, Executive Vice President And Chief Commercial 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 business financial forecast and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters payer coverage and reimbursement issues as well as intellectual property, pending litigation, other proceedings and competition. Each forward looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement.
A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities And Exchange Commission including its Form 10Q for the quarterly period ended September 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, conciliation 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 Sir, Doctor.
Len Schleifer.
Thank you, Justin, and thanks to everyone joining today's call. In third quarter, Regeneron delivered another strong financial performance of double digit top and bottom line growth, while achieving numerous milestones cocktail. Importantly our growth and financial strength is being fueled by an increasingly diversified set of revenue and earning streams while we invest in R&D for the long term. Furthermore, our results show the important products that meaningfully address serious medical needs and have the power to transport lives, even during a pandemic. EYLEA is a great example.
EYLEA global net sales were $2,100,000,000 in the quarter and grew 9% compared to the same period last year. In the and grew 11% versus prior year. The ethical safety and convenience that Eylea offers in protecting eyesight have proven to be highly valued by treating physicians and their patients as the product again outperformed the anti VEGF market proretinal diseases. Next, we continue to build momentum with Dupixent as we in Sanofi recorded our first ever quarter of more than $1,000,000,000 in sales. This milestone speaks to the power of Dupixent across a broad array of type 2 inflammatory diseases and to our team's ability to execute despite COVID-nineteen.
Adding to this momentum, we've recently announced results from another successful Phase III trial. This time in pediatric asthma, we are eager to submit these data for regulatory review and expect that Dupixent position in cutaneous squamous cell carcinoma. Additionally, the FDA has granted priority review for our regulatory filings in lung cancer and basal cell carcinoma as we prepare for potential launches in these indications early next year. Regeneron is also making critical advancements in the treatment of infectious disease Last month, the FDA improved Invisette, the first ever treatment for Ebola virus infection. Building upon our work in Ebola, our team and rapid response technologies have developed our novel REGN co2 antibody tail in the fight against COVID-nineteen.
Last week, we announced another major data set from our outpatient study that showed our antibody cocktails significantly reduced viral loads as well as medically attended visits such as emergency room visits and hospitalization We have submitted these data to regulators and eagerly await guidance on next steps. In closing, we could not be prouder of our teams in everything they have been able to achieve across the organization in the third quarter and in 2020 to date. Our momentum is accelerating with an impressive growth profile In 2021, we look forward to building upon that momentum with several important launches for Libtayo of Dupixent and other program. Further enhancing our diverse growth platform. We are excited by the progress we are making against COVID 19 And we are confident that our investments in R&D to broaden and advance our pipeline across all stages will position and return to unwell for sustained growth.
Now, I'll turn the call over to George.
And as Len just pointed out, we are advancing programs across all stages of our diverse and growing portfolio. With the pandemic unfortunately still raging and even escalating, we know there's a lot of focus on COVID-nineteen and we will start with our REGEN COF II program. From the beginning, there was a lot of attention to our efforts against the coronavirus because of our success using that our team delivered, validating our approach for not only this, but other deadly infectious diseases and particularly COVID-nineteen. We're investigating REGEN COV-two or antibody cocktail for COVID-nineteen in infected patients as well as for prevention in several ongoing clinical trials. Earlier this year, we released a descriptive analysis of the first 275 patients in the regen Cope II seamless Phase twothree trial in ambulatory patients.
Importantly, we obtained insights into the natural history of COVID 19 from these early data. Large numbers of patients normally generate their own antibodies against the virus. Early on. And this robust endogenous immune response is associated with rapid clearance of the virus and decreased need for medical attention. That's why most patients do so well.
However, some patients are slow to mountain immune response and are at higher risk for attended medical visits. In line with this observation, our initial analysis show that providing our exogenous antibody cocktail did not provide much benefit to the fast responders, but it benefit those who did not mount their own immune responses efficiently. Allowing regen coke to clear virus more rapidly and decrease the need for future medical attention in these otherwise slow responders. Last week, we provided important updates from this ongoing study in ambulatory COVID-nineteen patients in a formal statistical way We presented prospective validation of our earlier observation in a confirmatory analysis involving more than 500 additional patients. Data showed significant viral load reductions in patients treated with REGEN COF-two compared to Placebo and consistent with earlier data, These results were driven by the patients viral loads at baseline.
Importantly, results in the combined analysis of the first 799 patients enrolled in this study demonstrated a statistically significant reduction in medically attended visits, including hospitalizations and emergency room visits. This effect was most prominent with patients with high risk factors, high viral loads and those who had not yet mounted their own immune response. We shared these data with the FDA as an update to our EUA submission and await regulatory feedback. We are investigating the potential benefit of this regen coves to cocktail in different stages of disease in our other ongoing studies. Our household contact study, which is testing the cocktail as a prophylactic treatment, and it has enrolled approximately 1000 patients to date In hospitalized patients, we have 2 ongoing studies.
Our study, as well as the UK recovery protocol, All Regeneron sponsored COVID-nineteen treatment trials are being supervised by the same independent data monitoring committee. Which recently recommended that we pause enrollment in 2 cohorts representing the most severe hospitalized patients while recommending that all our other studies continue as initially designed including the 2 less severe patient cohorts in our hospitalized patient study. Since the lower of the 2 Regen Cope II doses demonstrate the activity comparable to the higher dose, suggesting that both doses maximize the benefit of this approach, we intend to investigate even lower doses going forward. If effective, this could allow us to extend the benefit of our cocktail to even more patients. As we await next steps on the regulatory front, we continue to ramp up production for regen cove too.
Under our U. S. Government agreement, we now expect to have 2.4 gram treatment doses ready for approximately 80,000 patients by the end of this month. 200,000 total doses ready by the 1st week of January and approximately 300,000 total doses ready by the end of January. We continue to increase our in house production capacity for further doses of regen coke II and are thrilled to be partnering with Roche to substantially expand global capacity of regen coke II as their production comes online early next year.
Moving on to Dupixent. We recently announced positive Phase III data in asthma for children ages 6 to 11. In this study, Dupixent reduced severe asthma attacks by up to 65% versus Placebo over 1 year. And Dupixent also rapidly and sustainably improved lung function in these children. We are planning to file these data with regulators early next year.
Additionally, in Europe, we received a positive CHMP Committee recommendation for Dupixent in atopic dermatitis in children ages 6 to 11. The Dupixent clinical program continues to progress and expand across a wide range of type 2 inflammatory conditions. In September, the FDA granted breakthrough therapy designation for Dupixent in eosinophilic esophageitis, based on early phase 3 results, which were recently presented at medical meetings. Before the end of the year, we expect to report Phase II data of Dupixent in combination with oral immunotherapy for peanut allergy. Additionally, Phase III studies are ongoing in several additional dermatology and pulmonary indications with readouts expected in 20222023.
And we expect to begin additional Phase III pivotal trials by the end of the year. Putting this all together, Dupixent will soon be in pivotal trials for 8 Type 2 diseases are not currently in the label and could address disease in nearly 1,000,000 additional patients in the United States alone. Dupixent is also an important part of our 2 pronged approach against chronic obstructive pulmonary disease or COPD. Along with atopicamab, our anti interleukin 33 antibody. Based on achieving a prespecified efficacy milestone in an interim analysis of our 1st Phase III study in Type II CRPD We initiated a second Dupixent Phase III study.
Data readouts are expected in 2023. We believe that our anti IL33 antibody could help an additional group of COPD patients beyond those with type 2 disease. Based on a proof of concept data that has been submitted for publication, we believe that blocking IL-thirty three could be especially useful in the former smoker COPD patient subset. The pivotal atopic AMAP program consisting of 2 parallel Phase III studies will initiate by year end. We hope that Dupixent and atopic demand can provide real benefit for the many desperate patients suffering from COPD.
Moving on to oncology and first Libtayo. At the European Society for Clinical Oncology the ESMO meeting in September, we shared results of our first pivotal of our pivotal first line non small cell lung cancer study as well as our locally advanced basal cell carcinoma or BCC study. These data are now filed as supplemental label applications with the regulators with the FDA recently awarding priority review for approval of Libtayo as a monotherapy in our proposed lung cancer indication. With an action date of February 28, 2021. We also announced that we completed enrollment in the Libtayo chemotherapy combination trial in first line lung cancer.
With first results from this study available as early as next year. Also, the BCC results presented at ESMO show that Libtayo has the potential to be the first approved treatment with the clinical benefit in the advanced BCC setting following failure of a hedgehog inhibitor. The FDA granted a priority review for our BCC filing with an action date of March 3, 2021. We continue to make significant progress with Libtayo as a foundation to our oncology strategy. Moving on to our oncology bispecific efforts.
We are in a pivotal program in non Hodgkin's lymphomas for our CD20xCD3 bispecific of your next demand, also known as regen1979. We're working towards initiating a pivotal program for regen 5458 our BCMA by CD3 bispecific for relapsedrefractory multiple myeloma. And in solid tumors, dose escalation for regen-four thousand and eighteen Our MUC16xCD3 bispecific continues in the 1st in human study in ovarian cancer in which we are observing preliminary evidence of activity. We are excited about the encouraging data potential advantage over other approaches is our ability to mix and match these CD3 bispecifics with not only our anti PD-one but also with our next class of bispecifics, the novel CD28 or co stimulatory bispecifics. Our CD3 bispecifics currently in the clinic are designed to be paired with matching co stim bispecifics for targets on a variety of different cancers, we see intent to synergistically unleash the power of immuno oncology more broadly than currently approved treatments.
Our first co slim bispecific PSNA by CD28 in combination with Libtayo for prostate cancer is progressing through dose escalation cohorts and thus far the therapy is well tolerated. We will soon start trials with 2 novel co stems, MUC16 by CD28 in combination with either our MUC16xCD3 bispecific or with Libtayo for ovarian cancer. And our EGFR by CD28 in combination with Libtayo for solid tumors, including in lung, head and neck and colorectal cancers. The first member of a 3rd class of tumor targeting bispecifics are met by Met bispecific, has recently completed dose escalation and is currently in the dose expansion phase of the 1st in human trial. Remember, this bispecific targets 2 distinct epitopes on the MET oncogene causing rapid internalization of this receptor and ablation of its signaling.
Met mutations are present in 3% to 4% and MET gene amplifications in about another 3% of non small cell lung cancers. Across our pipeline, We are pleased with the progress we are making across all stages of our rich oncology portfolio to compete, enhance and extend the power of immuno oncology to more patients suffering from a wide variety of cancers. Beyond oncology, our pipeline continues to expand. In our C5 program, we will shortly begin dosing healthy volunteers in combination with Alnylam's C5 RNAI inhibitor cemdisiran. The goal of the combination approach is to achieve Convenience Self Administration the subcutaneous dosage form in addition to the more complete and durable blockade of the complement activation in patients suffering from pacisimmal Nocturnal and hematuria and other complement mediated diseases.
This will be the first example of a combination of an antibody with an RNAi against the same target, and we believe that this could be the 1st in a series innovative antibody RNA combination that could change the treatment paradigm in multiple disease settings. We are also excited about additional collaborative programs including utilization of their siRNA approach against targets that we have identified through our Regeneron Genetics Center. As Alnylam has just announced, we have initiated dosing in siRNA against one such target, HSD17b13 for the treatment of NASH. Additionally, I want to acknowledge an important milestone for another innovative collaboration we have with Intelia. In the very near term, the first patient should be dosed with the groundbreaking systemically delivered CRISPR Cas9 gene editing therapy a potential 1 and done treatment for TransTheriden amyloidosis or ATTR as the first systemically administered gene editing intervention We hope that this will important new strategy for Regeneron as we attempt to broaden our efforts in the future of genetic therapies where we combine our capabilities and expertise to help empower those of our partners and to help change the practice of medicine and make new forms of gene therapy a reality.
By the end of this year, we and our collaborators will have introduced 8 new investigational therapies with the clinic, an accomplishment we are proud of in a challenging year. To conclude, we are looking forward to several catalysts over the next several months, We expect imminent updates and additional data readouts on our regen Cope II therapy. 1st regulatory approval for Evinacumab by February of next year, approval for 1st line lung cancer and basal cell carcinoma indications for Libtayo, filing for Dupixent in pediatric asthma and many more to come.
Thank you, George. Our 3rd quarter commercial results reflect solid execution across our core brands, Eylea Dupixent and Libtayo, We remain confident that the competitive strengths of our growing and diversified commercial portfolio will carry us through and beyond I'm going to begin with Alia, which grew 9% year over year to approximately $2,100,000,000 in global net sales, In the U. S, EYLEA grew 11% year over year with net sales of more than $1,300,000,000 as the anti VEGF demand recovered. In the U. S, EYLEA outperformed the category with share gains from both branded and unbranded competition.
In fact, IIDIA's share of the branded U. S. Category grew to more than 70% for the quarter based on volume, and Eylea remains the number one prescribed anti VEGF therapy in wet AMD and diabetic eye disease. Patient volume increased as those who file offering dosing flexibility, real world experience and established safety led to a quicker recovery and stronger growth across all indications than the competition. Eylea's flexible 12 week dosing regimen in wet AMD and the newly launched prefilled syringe also support ILEA's market leading value proposition.
We are monitoring the recent spike in coronavirus cases across the country, In some hotspots, retina offices are beginning to see some modest reductions in patient volume, which may impact future EYLEA demand. That said, retinal offices have become highly effective in managing their patients in this environment compared to the early days of the pandemic. In summary, Eylea had an impressive quarter. Turning next to Libtayo. 3rd quarter global net sales grew to $96,000,000, In the U.
S, net sales were $72,000,000 with describing. Libtayo continues to drive overall market growth in advanced cutaneous squamous cell carcinoma and remains the most prescribed systemic treatment for CSCC. Eylea remains the anti PD-one of choice with nearly 90% market share of the class. The overall profile of high response rates with many complete and durable responses positions Libtayo for continued growth. To fuel additional growth, we anticipate 2 new potential indication launches in non small cell lung cancer and basal cell carcinoma in the first quarter of 2021.
For basal cell carcinoma, we aim to build upon our success in CSCC and establish Libtayo as the standard of care for non melanoma skin cancers, We expect Libtayo to be 1st in class and will work to establish it as the standard of care in 2nd line BCC. Non small cell lung cancer is the largest opportunity within the PD-one space with more than 200,000 new diagnoses of lung cancer in the U. S. Year. We plan to leverage our oncology presence as a majority of treatment centers in oncologists are familiar with Libtayo and CSCC.
We believe that patients, providers and payers prefer choice in determining the most appropriate treatment. Libtayo demonstrated an overall survival benefit in a real world, higher risk population of patients, including patients with stable brain metastases, infections and progressive disease. These data, along with an additional product attributes, support Libtayo is a potential new option for anti PD-one monotherapy in the treatment paradigm. Finally, moving to Dupixent. Global net sales in the 2nd quarter were $1,100,000,000, representing 69% growth compared to the prior year.
In the U S, broad based growth across all indications contributed net sales of $851,000,000. Among all specialties, patient visits improved throughout the quarter as the healthcare field has adapted to treating patients in the COVID environment. Current weekly new patients starts have recovered in our nearing pre pandemic levels, the 300 milligram pre fill pen was launched this quarter providing additional patient convenience and choice. Atopic dermatitis remains Dupixent's largest indication and is a significant growth driver based on its rapid onset proven efficacy and well established safety profile. We continue to expand prescribing across both moderate and severe disease, despite the impressive growth trajectory since launch, a low percentage of biologic eligible patients have been treated leaving substantial opportunity for more patients to benefit.
Our ongoing launches for both adolescent and pediatric patients are progressing very well. Since the main launch of the pediatric indication, we are seeing encouraging trends comparable to the adolescent launch or initiations only 400,000 adolescents and 90,000 children in this country that could benefit from Dupixent therapy. Moving to asthma. Dupixent continues to perform well in the competitive asthma space based on its clinical efficacy and safety profile. Our National DTC campaign is well underway, and we are seeing an uptick in new initiations.
We look forward to submitting our pediatric clinical data to regulators, which could lead to further label expansion and benefit as many as 75,000 eligible children. Additionally, we see strong uptake in chronic rhinosinusitis with nasal polyps, Since approval last year, patients been initiated on Dupixent, regardless of prior surgery, while the availability of elective surgeries has improved as healthcare facilities have reopened, demand for Dupixent remained strong among ENT's analogists. Dupixent is making an important contribution to our business and we're excited about the significant opportunity for future growth from our in line business and from new potential indications, age groups and geographies. In closing, our commercial teams delivered strong performance across our diversified portfolio. We have Additionally, we will enter a new phase and Lung and BCC for Libtayo.
These launches will add to our momentum and the significant growth of our business These are very exciting times at Regeneron. I'll turn the call to Bob.
Thank you, Marion. For the third quarter of 2020, Regeneron delivered strong based growth on both the top and bottom lines, resulting from continued execution across all aspects of our business. Improving Dupixent profitability and contributions from additional revenue sources highlight the continued diversification of our business. For the third quarter, total revenues grew 32 percent year over year to $2,290,000,000, driven by strong U. S.
EYLEA growth in higher Sanofi collaboration revenues as a result of increased Dupixent sales and achievement of a $50,000,000 sales milestone. Non GAAP diluted net income per $61,000,000. Since Marion discussed our U. S. Eylea results, I will start with our Bayer in Sanofi collaborations.
Starting with the Bayer collaboration, ex U. S. EYLEA net product sales reported to us by Bayer were $780,000,000, representing growth of 7% on a reported basis, compared to the prior year in a 22 percent improvement from second quarter 2020 lows. Total Bayer collaboration revenue was 300,000,000 of which we recorded $288,000,000 for our share of net profits from Eylea sales outside the U. S.
Total Sanofi collaboration revenue was $353,000,000 in the third quarter. Our share of the profits from the commercialization of non IO antibodies was $213,000,000. This compares favorably to profits of $94,000,000 in the prior year, which was primarily driven by higher Dupixent profits. We also recognized a $50,000,000 milestone payment from Sanofi as a result of Dupixent, Praluent and Kevzara ex U. S.
Sales, achieving $1,000,000,000 in the trailing 12 month period. Next, we announced in July a $450,000,000 supply agreement with the U. S. Government for batches of REGEN COV-two. We record sales as batches are supplied to the government.
In the third quarter of 2020, under this agreement, we recorded an initial $40,000,000 of sales for REGEN COV-two. We expect that in the fourth quarter of 2020, we will record sales approximating half of the value of this agreement. Sales for the remaining batches are expected to be recorded versus $37,000,000 in the prior year. The primary driver of this increase is the recognition of $70,000,000 from the U S government associated with reimbursements of our Ebola and REGEN COV-two development recognition of $28,000,000 in connection with the Regeneron Genetics Center sequencing a certain number of ex homes, as well as a reimbursement for ex U. S.
Supply of PRagulant to Sanofi. Looking ahead to the fourth quarter 2021, we expect the other revenue line to trend lower in the absence of an RGC milestone and reduced reimbursements from the U. S. Government on Ebola. Moving to our expense basis, starting with R&D, Non GAAP R and D increased 35 percent year over year to $629,000,000, driven by significant clinical development costs for our REGEN COV-two antibody cocktail, higher headcount to support our expanding pipeline, increased clinical manufacturing activities, and continued advancement of our partnered programs with Alnylam, Intellia and other early stage partners.
Next, non GAAP SG and A expense increased 10% year over year to $291,000,000. The year over year increase was largely driven by increased headcount as well as commercial costs for Eylea and Praluent. Cost of collaboration and contract manufacturing was 143,000,000 compared to $110,000,000 in third quarter of 2019, primarily due to increased sales of Dupixent. Non GAAP cost of goods 22% from the prior year related to higher sales of Libtayo and the inclusion of sales from Praluent and REGEN COB-two. Turning now to taxes.
Percent in the third quarter of 2019, primarily due to discrete items to the quarters. Shifting now to cash flow and the balance sheet. Regeneron continues to maintain a strong balance sheet ending the quarter with cash and marketable securities of $5,900,000,000. Our 3rd quarter free cash flow was negatively impacted the extension of Eylea payment terms to support physician offices during COVID. We expect this will reverse in 2021 as payment terms return to normal.
Additionally, in the quarter, we issued $2,000,000,000 of long term debt leveraging historically low interest rates, while decreasing our cost to capital. With issuance of this debt, we expect to incur approximately $45,000,000 of incremental interest expense on an annual basis Finally, we repurchased $100,000,000 of stock in the third quarter as part of our $1,000,000,000 board authorized share buyback program. Now, I'd like to spend a few where in many cases, we either lowered or narrowed guidance range. Please refer to our press release for our entire updated 2020 guidance. Specific to R and D, we are revising upward our forecasted 2020 non GAAP R and D expense to be in the range of $2,420,000,000 to 2.47000000000 While we increased R and D guidance on our second call to reflect REGEN COV-two expenses, we have since substantially expanded to scope and enrollment targets across the REGEN COV-two clinical program which will result in increased expenses While we are not providing 2021, 2021 guidance today, we do expect that 2021 full year R and D expenses will increase the fund in advancing and expanding pipeline as well as early stage partnership assets.
In conclusion, Generon's business remains healthy and we continue to deliver strong year over year growth as we diversify our revenue and earnings and advance our robust pipeline. We remain well positioned for future growth with healthy core brands and multiple near term launches, while investing in our R and D engine to drive longer term growth. With that, I'd like to turn the call back to Justin.
Thank you, Bob. Deborah, that concludes our prepared remarks. We'd now like to open the call for Q and We have more than 20 callers in the queue. So to ensure that we are able to address as many callers as possible, we will answer one question from each caller before moving to the next Please go ahead Deborah.
And we'll go with our first question. We got Carter Gould with Barclays.
Good morning, guys. Thanks for taking the question. I guess, for George and Len, clearly, a lot enthusiasm around the potential for the co stems as we look to some of those readouts. I guess look to 2021, are we going to have a clear signal if these are, living up to their promise in 2021? I know moving through some of these dose escalation takes time, but do you guys have confidence we'll be in a position to have a clear read on if they're living up to their hype next year?
Thank you.
Well, it all depends on, as you said, these dose escalation studies, how they progress in proceed. We certainly hope that we will be getting signals of efficacy sooner rather than later, but it all depends on the clinical development and how that all goes. But we remain incredibly enthusiastic and excited about this class. And we're investing enormously, as I said, we have pairs of CD3 and CD28 bispecifics for numerous different cancers, not only the ones that are already in the clinic, but ones that will be entering into the pipeline over the next year or 2 or 3. So we're very excited about this class and the potential of combining them with the 2 sets of bispecifics as well as with the PD-one.
Next question please.
And your next question comes from Chris Reitman with Piper Sandler.
Hey, thank you. Just on Regeneron COV-two, just wondering if you could walk through the biology behind why there would be a safe signal in these fented or high flow oxygenated patients. I mean, I guess, especially given how clean it looked in mild to moderate cases, is there some threshold of viral load or is it underlying over activation of the immune system that's driving this problem? And can you maybe describe the AEs, please? Thanks.
So first of all, we should point out that we remain blinded to what's going on in those 2 cohorts that were paused. They weren't halted. They were paused so that the IDMC could evaluate the ongoing patients and then decide what to do going forward. We do not know whether there really is any safety signal. And as you said, I think theoretically, there is not really a great deal of rationale why there might be a safety signal there.
You could come up with all sorts of, complicated scenarios to explain it. But until we're unblind to the data until we really get to look at it, at this point, it could simply be that there's lack of efficacy or maybe even early trends, which will reverse. So as you said, theoretically, it does not make a great deal of sense. I think the whole concept of what they call AD or antibody dependent enhancement is something that does not look like it's really playing a role in this disease. So we remain hopeful, that there is not going to be a safety signal and eventually at least in some subset of these patients, even the hospitalized patients that we may provide a benefit.
Your next question comes from Evan Sigerman with Credit Suisse.
Hi guys, thank you so much for taking the question and I'll limited to 1. So in the 10 Q, you listed, the EUA for the AV cocktail during this quarter. Is this official guidance from the FDA And any ideas to what patient population that this EUA would be granted for?
So it's Lynn. We've said that we are focusing on the a patient population where the data comes from, which is outpatients, who have the best baseline characteristics, which would make us think that they would benefit the most, whether that's risk factors or high viral titer or eventually perhaps low antibody. Those are the sorts of patients we're focused on as an outpatient. There is no PDUFA timelines the EUA. We expect action in the relative near future, but there's no guarantee that will come.
The FDA is doing a a very careful analysis. We can tell from the kinds of questions we're getting, and we hope that it'll be, reach a successful conclusion, but We don't know the timeline because there are no specific timelines. We do know they're working just about as hard as we've, can imagine and ever seen the FDA work. So we're, hopeful soon we'll get an answer.
Great. Thank you so much.
Next question please.
Your next question comes from yatin Sanjay with Duggenheim Partners.
Hi. Thank you for taking my question. Question is on Eylea. Obviously, a very solid quarter. Can you maybe just give us some sense on the relative contribution from AMD versus other indication, how the market share is evolving in DME, what level of penetration you have achieved?
And then obviously, COVID is spiking in the Q4.
Oh, yes, Tim, one one question. So so far you're up to 3. Marion, can you answer the first one?
I'll do I will do my best. And, first, let me comment that in the times of pandemic, there probably was more of an impact on patients with diabetic eye disease, not either receiving a diagnosis or coming in for treatment, but we're starting to see recovery in that. I'm pleased to report that on the split of use of AYEA by indication, We are approaching 60% for wet AMD, which means over 40% of our business is coming from other indications inclusive of diabetic eye disease. So on balance, we continue to see diabetic eye disease as our largest future opportunity going forward But we are the market leading anti VEGF therapy across all indications.
Thank you.
Next question please.
Your next question comes from yaron Werber with Cowen.
Yeah. Hi. Good morning. Just a quick follow-up on the Regeneron Cope. 2, the ongoing studies, George, are still across all patients, not just seronegatives.
You clearly saw activity in seronegatives. Lilly sort of obviously both with their single and combo really didn't see the same data. So any explanation to that and why you still sort of doing studies across all patients? Thank you.
Yes. I'm not sure what you mean by Lilly didn't see the same thing. They didn't actually look for where their effect of any untoward effect and maybe just a very small benefit in the seroposit patients who have their own antibody. I think that if one could actually do point of care testing, which is unfortunately at this moment, not immediately available in most cases, once the drug might be available, let's say, under an EUA, you might want to limit it to patients based on those characteristics. However, because the benefit risk does not have any evidence of negative untoward effects in those individuals, One could just treat the entire population, even though the benefit is mostly driven by those who are, as we described, are seronegative have higher viral loads and or, have high risk factors.
Okay. So just to amplify what George said, Yaroni, and said it out. I just think it's worth repeating that we did see an effect in the overall population. It's just, as he said, that effect was driven by the people who needed the antibody and that they hadn't mounted their own immune response. That observation which is something that the team predicted, which is that people who mounted their immune response wouldn't benefit so much from giving them more of an antibody makes perfect sense and those that hadn't mounted their own immune response would benefit much more also makes perfect sense.
And that is exactly what they saw And you even see it in the placebo treated patients that if you don't have antibodies, you start with a very high viral load. If you do have antibodies, you're already 3 logs lower. So all of the biology that George and the team predicted and described was born out in a very exciting way. So I think it's just a matter of, where you see the effect being driven by not whether or not you can treat an entire population.
And I'm sure, by the way, if Lilly did the same detailed analysis, they would see that their benefit would also be driven by the same sets of patients. They just didn't do those analyses.
Next question comes from Jeffrey Pope with SVB Leerink.
Hi. Just a follow-up question on Covey too. I'm just not sure how this is going to work. We can't even execute testing in this country reliably. So how are you going to screen the individuals who aren't mounting an immune response on an outpatient basis and then initiate treatment on an outpatient basis.
It's just confusing. So help us understand that. And would it be sensible to treat everybody going to hospital for, elective procedures of any kind or something else along those lines. It's just a little confusing how you're going to use this medicine.
Right. I think what as we just said and as Len amplified on, the effect is seen in the overall population It's just driven by those individuals, who have the characteristics that we described. The notion is that just as in the clinical studies, it could be given to all, of the eligible outpatients, because there is no risk, to be to the individuals who won't benefit the most. So I think that the strategy that, of course, I think, would be taken would be to limit the drug right now without doing any of the advanced screening and so forth. But to the people who are at the highest risk of progressing to needing medical attention, Give it to those people irregardless if you don't have the point of care testing irregardless of the baseline viral load or their antibody status.
In the future, if such testing became available, then you might not want to waste the drug. On the people who might not benefit. But initially, I think it'd be given to the people who are at the highest risk of developing complications. With the goal of preventing those as we showed in the study, you will reduce dramatically the need for further medical attention if you give it to individuals in the higher risk the population that you give it to, the NMT goes down. But, the only reason really to limit it at this point is because there's going to be limitations for the amount of doses available to Street.
Yes. Let me just also add to that, Jeff, so two things. First of all, as I think George pointed out in his presentation when we first disclosed this data, there's a very high correlation between the baseline viral load and whether or not you have antibodies. It's on average, your 3 logs higher if you don't have antibodies in viral load. So you could use viral load.
Everybody who's going to get treated has a viral load test. They have a PCR test. It's reported as back as positive, but there's actual cycle times I think the testing of reporting, a testing doesn't necessarily have to change, perhaps the reporting has to change, in terms of what your cycle time is, a very low cycle time, you need very high, level of viral load predicts lower no antibodies. So that could be used, as George said, to screen patients. The second thing is our partner Roche is really one of the probably is the leading company for testing.
They have a platform for antibodies that can test, 100 of millions of people per quarter, and it's deployed in, I think, like 70,000 different points of care, So we're working with them to see whether that test can be validated with our data set or not. So I think there are lots of ways to get at this. You could use you can treat everybody obviously limiting to the people who have risk factors or you could start to narrow it down to people who have high viral load, low cycle time or eventually with our partners' capabilities, people who at point of care have no antibodies. So I think there's a lot of flexibility. It's just We don't have all this button down in this emergency situation, and it will probably evolve fairly quickly, if we get an EUA.
But just to simplify, initially, we believe it will be used in the overall population based on risk factors without regard to serology or viral load. And as Lynn said, eventually, as these approaches evolve and change, it may allow targeting of the drug to those who might even benefit the most.
Next question comes from Cory Kasimov with JP Morgan.
Hey, good morning guys. Thanks for taking the question. I have plenty more on Cove II, but given the number we've already had there, I'll change the subject. I want to ask Bob about the R and D spend and really thinking about trends going forward. So in terms of the investment you're making on the antibody cocktail, how long do you expect this to kind of persist forward?
And just kind of overall wonder if you get give us any sneak peek into 2021? Thank you.
Sure. Thanks, Corey. Let me see if I you a little
bit of color. So as I said
in our prepared remarks, we're not going to provide 2021 R and D guidance today. We do expect that next year's R and D expenses will be higher to support pretty much everything that George said with regards to the expanding pipeline, early stage assets, the partnerships Illnylam and Intellia, which are really starting to blossom and certainly our ongoing COVID-nineteen efforts. If you look at 2020, Where we sit right now, we anticipate spend of approximately $400,000,000 on our efforts against COVID 19 within the year of 2020. So if you back that spend out from our full year 2020 non GAAP R and D guidance midpoint, Our underlying growth rate in R And D spend, excluding the COVID program efforts, is trending about 15% higher than our 2019. As our, as we move forward.
So Cory, I would use that kind of as a stake in the ground. In terms of where we're going to go. I mean, certainly our COVID-nineteen spending is going to continue on. People can see on cleantrials dot gov with the the extent of the programs that we have, trials that we have going, that will play a factor into, into 2021. That's helpful.
Thanks, Bob.
Next question please.
Your next question comes from Robin Karnauskas with Truist.
Hi, guys. Thanks for taking my question. Another one on COVE 2. So just because it seems like this pandemic is just getting much worse in the United States and globally. Can you talk about your efforts to expand manufacturing next year beyond the $300,000?
And then I was just curious given high profile it was that the President and others got a combination different combination therapies. Can you biologically talk about your thoughts on, should this drug be combined with Dex or other drugs immediately upfront biologically? And when would you just start like maybe combo trial that would sort of evaluate that to sort of really make sure that this is a cure rather than just reducing the viral load and reducing time to recover in some patients? Thank you.
Was going to say George can deal with that. I was going to just deal quickly with the manufacturing question, which is we are scaling up and we to be able to make substantially more next year than we were able to make this year. Obviously, we'll have a full year of manufacturing which we didn't we did not have a full year of manufacturing to deliver the 300,000 doses. And we expect to have more facilities that are now operational and dedicated, plus we expect to multiply that with our partner Roche who really has been a terrific partner so far. And they, as you know, because we see, we see them might because we compete with them in many fronts.
They're really sophisticated in the biologics space, with their Genentech history and their manufacturing capacity. And they're working very hard to bring online, a very enhanced and large manufacturing capacity. I'll let George deal with the question about combination therapy.
Yes. I think the most important thing to note is because the mechanism of action Our treatment is just an antibody that is essentially analogous to the endogenous antibodies that many of the individuals are making. As I described, we're just providing it to those people who are either slow or failing to make their own antibodies. There's no expectation in no mechanistic rationale for any, safety interactions of concern. There should not be any reason why you couldn't mix this with essentially any drug that doesn't have untoward side effects because all we're doing is giving you more the antibodies that your body normally makes.
So that said, that you could theoretically combine our treatment with any other treatment without any reason to believe that there would be negative interactions. I remind you that right now, where our data stands and where we are we have filed for the EUA is in the outpatient setting, where these other modalities are not being given at this point. So it's going to take future studies plus analyses in the hospitalized patients, where you look at patients who had combination therapies to determine whether patients who have these combinations do better than patients who just receive 1 or the other therapy alone. But in the outpatient setting right now with our data, It'll be all antibody because those are not patients where remdesivir or dexamethasone is currently a standard of care.
Great. Thank you.
Next question please. Next question.
Alethia Young with Cantor.
It's important. It's doopie. I just want you guys to talk a little bit about the potential growth opportunity you see there. Obviously, you've had incredible launch so far, but you've gone deeper into commercial marketing and DTC. And I just kind of want to think about how do you drive deeper penetration into biologics both biologic market, both in ADN also, sorry, asthma.
Thanks.
Certainly. I'm happy to comment. And today, certainly, we reported as did Sanofi, you know, very strong results for Dupixent, both in the U. S. And ex U.
S. Markets. The really important thing to keep in mind as well, we've made certainly inroads and helping atopic dermatitis patients and patients with respiratory conditions of asthma and nasal polyps there still are, in all those indications that are currently approved, not to mention the future indications, a lot of incremental unmet need. And then beyond that, to your point of strategies and promotional platform and activities to advance the market, Jupixson has been very responsive to promotion. We've been seeing, certainly uptick in new initiations and also a remarkable, consistency of patients staying on therapy because of the results that they're receiving either in their skin condition or their respiratory condition.
We'll continue to do that. We're looking at a lot of different mechanisms for advancing our promotional platform. We have highly effective field teams in the marketplace We also benefit from very strong reimbursement have. And we'll be very, very well prepared for our future indications as well.
And your next question comes from Ronny Gal with Bernstein.
Congratulations on the very nice quarter. My question is actually on the Eylea Lucentis dynamics. You've shown a 10% revenue growth. They've shown a 5% revenue decline year over year. Obviously capturing share, but I was wondering about the new patient volume.
If you can just share with us if you could, kind of like where are we in terms of patient new patient starts versus a year ago? And how far do we have to go before we come back to line? And anything you can share pricing terms, it seemed to be you've commented this in the, in the press release, if you can give us a bit more there.
In terms of performance of EYLEA in the anti VEGF category. As I mentioned, we are seeing, a rebound in terms of patient treatment coming back into offices, we see an advance in Eylea's performance versus a year ago. And then coupled with that, we are seeing an increment in share gain from both branded and unbranded competitors. I also mentioned if I just put it into volume terms for you in the branded marketplace that Eylea now approaches is just over, in fact, 70% of the branded market in the quarter by volume. So we're seeing robust performance and we would attribute that to Eylea's overall value proposition for, retina specialists in choosing anti VEGF therapy, the certainly the clinical profile, efficacy profile, flexibility of dosing.
Now the prefilled syringe is incredibly timely as a convenience, but all in the current environment of office throughput and efficiency. And then beyond that, the established safety.
Operator, we have time for 2 very quick questions. If we could try to squeeze them in.
Your next question comes from Berenna Mann with Jefferies.
Yeah, hi guys. Thanks for taking my questions. Can you just talk about the competitive landscape in retina with your thoughts on Furosemab given we've they're going to have Phase III data relatively soon.
Sure. So I think we all learned a lot about I'm sorry, Len, you go first. I'll come back if you like.
No, go ahead, Mary.
No, I
was just going to comment that I think that, for a product entering the marketplace today, It's not assumed anymore that, a safety profile will be there until the product has, you know, actual market experience. I just would mention at the start, we always monitor competition very, very carefully, both in market currently and future competition But certainly, Eylea sets a very high bar in terms of the clinical profile, the safety profile, and the level of experience. But Len, over to you.
No, I think you covered it. Let's go to the next question, the last question.
Your final question comes from Terence Flynn with Goldman Sachs.
Hi, this is Dan on for Terrence. Thanks for taking our question. Just for the phase 2 trial of your BCMA bispecific antibody, just wondering if you could share any more details on the trial and if you're working to develop this subcu formulation. Thanks.
Yes. I think that, right now, we'll you'll get updates on the BCMA program at ASH, We have announced that we're going to be entering into a pivotal program very soon. And I guess It's fair to say that it makes sense that we would be developing, yes, a subcutaneous formulation.
Great. Thanks to everyone for joining today's call. We appreciate you dialing in knowing that many other companies are reporting today. So thank you for your attention for your questions. Bob Landry and the IR team will be available for additional questions and calls as needed today.
Thank you, everyone. Be safe.
This does conclude today's conference call. Thank you for your participation. You may now disconnect.