Welcome to the Regeneron Pharmaceuticals First Quarter 2020 Earnings Conference Call. My name is Crystal, and I will be your operator for today's call. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session. Please note that this conference is being recorded.
I would now like to turn the conference over to Justin Hoco, Vice President of Investor Relations. You may begin.
Thank you, Krystal. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron Pharmaceuticals and welcome to the first quarter 2020 conference call. An archive of this webcast will be available on our website. Joining me on the call today are 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 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 forecasting guidance, development programs and related anticipated milestones collaborations, finances, regulatory matters, payer coverage and reimbursement issues, intellectual property, pending litigation and other proceedings and competition.
Each forward looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities And Exchange Commission, including its Form 10 Q for the quarterly period ended March 31, 2020, which has been filed with the SEC today. Regeneron does not undertake any obligation to update publicly any forward looking statements whether as a result of new information future events or otherwise. In addition, please note that GAAP and non GAAP measures will be discussed in today's call. Information regarding our use of non GAAP financial measures and a reconciliation of those measures to GAAP is available in our financial results press release, which can be accessed on our website.
Additional information about those measures is all available on the Investor and Media section of our website. Once our call concludes, Bob Landry and the IR team will be available to answer further questions. With that, let me turn
Thank you, Justin. Goal time. We're living in a new reality, the reality of COVID-nineteen. I am incredibly proud of the leadership role Regeneron is taking in the fight against COVID-nineteen. Clearly, this pandemic is unprecedented in our lifetime for our company, our country and the world economies.
Regeneron has spent decades and 1,000,000,000 of dollars developing prior to our technologies that have created medical breakthroughs such as Dupixent and our novel antibody cocktail for Ebola, which is now under FDA review. These same technologies are now well purposed for finding a treatment against the SARS CoV-two virus. We are making rapid progress in scaling up supply of our novel antibody cocktail, which we expect to be in clinical trials this June. We are optimistic about we are working swiftly with our collaborator Sanofi to find a definitive answer on whether there is a role for Kevzara in helping to alleviate the devastating inflammation that affects patients who are critically afflicted with this virus. We are grateful for the tremendous partnership across industries, governments and agencies such as the FDA and BARDA as we unite in the common cause to eradicate this disease.
Beyond our therapeutic efforts, we continue to respond to other urgent COVID related needs. We recently produced and donated viral transport media to New York State for use in 500,000 test kits and have provided financial support to nonprofits at the heart of the pandemic response in New York and beyond. Furthermore, we are sensitive to the rapidly evolving marketplace and working with customers to ensure that patients are able to receive the treatments they need to preserve vision as well as to treat inflammatory conditions, cancer and other ailments that persist despite the realities of social distancing. Turning to some brief commentary the first quarter where we delivered another strong performance. In the quarter, negative impacts from COVID-nineteen were minimal.
Our core brands, Eylea, Dupixent and Libtayo drove significant top and bottom line growth based on demand while we invested in and advanced our innovative pipeline. In this quarter, Eylea global net product sales grew 6% to $1,850,000,000 including U. S. Eylea net sales growth of 9% to $1,170,000,000. In the last 2 weeks of March early April, overall demand and new patient starts were softer due to team.
However, we are encouraged by the rebound in demand in the most recent weeks. Marion will give you more color on this. First quarter Dupixent sales more than doubled compared to last year and are now annualizing at more than 3,400,000,000 on continued market penetration and new launches impacts on new patient starts. We expect continued resilience for Dupixent during this COVID-nineteen period given the profound efficacy and safety profile. With an anticipated regulatory action in pediatric, a topic dermatitis later this month and other data readouts in 2020 and initiation of new Phase III trials assessing due Dupixent and several other type 2 inflammatory diseases.
This exceptional medicine continues to be positioned for long term growth. Importantly, Dupixent is driving continued diversification of our earnings base and enhancing our current our strong current and long term financial position. We also announced recently that we have completed the restructuring of our agreement with Sanofi Unpreluent, which will lead to immediate accretion and further strengthen priorities. Even though we are experiencing impacts to trial enrollment and new study starts, we remain on several significant clinical milestones, particularly in oncology. Recently, we announced that our first line clinical trial in lung cancer assessing Libtayo was stopped early on an interim analysis due to superior overall survival versus chemotherapy.
We will look to submit these data to regulators as soon as possible. We also intend to submit data for Libtayo and basal cell carcinoma and expect new data from our bispecifics program later this year. Additionally, the long awaited Phase III readout from fasinumab our anti nerve growth factor program for osteoarthritis pain will occur in the coming months. Before handing the call over to George, I want to share the immense pride and gratitude we have for our people working hard at Regeneron during this time. Even in essential to our mission to patients and to near and long term value creation for shareholders.
Our ability to do this rests on the talent and strength of our workforce, which in spite of COVID related disruption maintains incredible commitment, focused and effort to advance the breadth of Regeneron's work. They are the foundations for moving forward, our mission in normal times and especially now. We are optimistic that Regeneron and our society will prevail through these unprecedented times. And we will work tirelessly
Thank you, Glenn. And since the devastating COVID-nineteen crisis is foremost on everyone's mind, I will first discuss our efforts in this area. As you all know, our state of the art and proprietary Velocity Suite Technologies, which we have built over the last few decades, can be very powerful for responding to new targets and pathogens as we recently proved by rapidly creating an antiviral antibody cocktail as an effective treatment for Ebola. Recall, the FDA recently granted priority review to this treatment for Ebola with the target action date of October 25th, 2020, based on the results of the phase 3 Palms clinical trial conducted in the Congo which was stopped early because of our Regeneron EB3 antibody cocktail proving superior and preventing death compared to the previous standard of care the so called ZmAP antibody as well as 2 roomdesivir. In terms of COVID-nineteen, While society is awaiting an effective vaccine that could still be a year or 2 away, we are employing a 2 pronged approach that could serve as a useful bridge and or as an alternative to a vaccine.
1st and most importantly, we are developing a novel antiviral antibody cocktail just as we did for Ebola. We have already announced that we have utilized our Velocity Suite Technologies to rapidly generate and select 1000 of potent antiviral fully human antibodies from both our genetically humanized velocinune mice as well as from convalescing human volunteers, creating what we believe is the largest and deepest collection of potent antiviral antibodies to choose from. We have selected 2 distinct antibody cocktails from this collection, our initial cocktail as well as the backup and we have already begun large scale manufacturing and anticipate initiating clinical trials with the lead cocktail in June. With BOLA, we set the record of 9 months from initiating the project to start in human trials. Now, we hope to break that record with 5 months from project initiation to the clinic.
Based on our experience with Ebola and other viruses, we hope that this specifically designed anti viral approach has a significant chance for success in providing both a prophylactic treatment to prevent infection in those at risk as well as for treating those already infected and symptomatic. Our second major COVID-nineteen approach involves repurposing Kevzara, our anti IL-six receptor antibody approved in rheumatoid arthritis. Based on a small uncontrolled case series from China, there was reason to believe that blocking the IL-six pathway might address the underlying inflammation leading to acute respiratory distress in so called severe COVID-nineteen patients. Meaning hospitalized patients needing oxygen support, but not on ventilators. As opposed to so called critical patients, who largely require ventilators.
We initiated an adaptive phase twothree trial to explore KEVZARA in both the severe and critical patient populations. Our initial data from both the phase 2 and phase 3 portion of the trial indicated that Kibzara at least at the doses tested, which parallel those used in the China reports did not provide a major benefit for severe patients. On the other hand, the phase 2 portion of the trial suggested a potential benefit in critical patients and the phase 3 trial in this group is ongoing. Additional efforts both in our program and by our Sanofi partners in Europe and the rest of the world are further testing both of these populations including at higher doses. Our results and efforts with Kazzura highlight the challenges with using repurposed drugs the inability to rely on uncontrolled and even small controlled trials and thus the importance of running large, well controlled Phase III study to obtain real answers as to whether a drug has benefit and the quantitative extent of that benefit, even in the pandemic setting.
It is important to point out that our efforts with COVID-nineteen are being developed under an ongoing collaboration with BARDA, a division within the U. S. Department of Health And human services and also involved incredibly collaborative relationships with so many critical partners from the FDA to the leadership of New York State to the many hospitals and physicians at the front lines who make the effort to engage in these trials and the many stricken patients who volunteer to participate. I also want to thank all the individuals at Regeneron who have continued to work tirelessly on these programs. Despite all the logistical and operational and health challenges created Moving on from COVID-nineteen.
D2B essential in selecting anti VEGF treatment. Over the last several months, another recently approved anti VEGF product was recently associated with a serious new vision threatening safety concern involving occlusive retinal vasculitis in the context of intraocular inflammation in light of the frequency and serious nature of the safety concern, Regeneron and our partner Bayer conducted a broad review of our clinical trial database as well as our post marketing global safety database to identify any similar safety involving tens of 1000 of injections, there was no reports consistent with the safety concern. Moreover, in the extensive post marketing experience involving more than 32,000,000 doses of Eylea, sold in more than 100 countries worldwide since its approval more than 8 years ago, the rate of any possibly related safety event was less than 1 out of every 6,000,000 EYLEA doses sold. In such cases, we're always associated with presumed infectious end up Thus, based on our reviews of the Eylea clinical trial database and post marketing surveillance, occlusive retinal vasculitis in the context of intraocular inflammation does not appear to be a safety concern with the use of Eylea. Next, I want to discuss Dupixent.
Later this month, we anticipate an FDA decision extending Dupixent approval to six to eleven year old children suffering from atopic dermatitis. Dupixent would be the first biological indicated for this pediatric population. We hope this potential approval will continue to reflect the remarkable safety profile of Dupixent as evidenced by the absence of a black box warning or any associated serious infection risks, which are often seen with immunomodulatory biologics and with JAK inhibitors. We also expect FDA action on our 300 milligram auto injector, which would allow for an additional dimension of convenience to an already strong profile for the medicine. Additionally, later this year, of our eosinophilic esophagitis program.
And we remind you that we have pivotal studies in chronic spontaneous urticaria kurigu, Nagularis and Bullis Pemphigoid, as well as studies in oral immunotherapy with our collaborator, Aimmune. We continue to build on the fix and story, which has already changed the lives of so many people suffering from Type 2 inflammatory diseases, such as asthma, atopic dermatitis and chronic rhinosinusitis with nasal polyps with more than 150,000 patients treated globally since launch. Next, I'm excited to share important updates on our immuno oncology efforts. As you know most cancer patients are still not successfully addressed with immune therapies leaving us with a major challenge of enhancing responsiveness in tumor settings where immune therapies already have some efficacy such as lung and melanoma while also trying to extend the benefit to patients with tumors that are currently not highly responsive such as prostate, pancreas, and colon. Having our own effective anti PD-one antibody is foundational for our efforts to enhance and extend the benefits of immunotherapy as we had hoped such an antibody could play an important role, both as a monotherapy, but also in combination with other antibodies and bispecifics derive from our own homegrown pipeline, as well as in combination with a number of collaborative agents and vaccines.
Defying early optimism, developing effective anti PD-one antibodies has proven to be very challenging. It is remarkable that in the decade since the first approval of an immuno oncology agent, only 1 PD-one antibody has been approved as monotherapy in 1st line non small cell lung cancer. Although that therapy has, on its own, completely changed the paradigm of how lung cancer is treated. At the end of last year, we announced interim results from our first line non small cell lung cancer study, in so called PD L1 high patients, revealing that our PD-one antibody Libtayo as monotherapy had objective response rates of 42% compared to 22% for chemotherapy, indicating profound clinical activity. Just last week, we announced that the Independent Dana Monetary Committee recommendation led to an early termination of this Libtayo monotherapy trial due to a highly significant improvement in overall survival, with Libtayo decreasing the risk of death by 32.4% compared to the platinum doublet chemotherapy.
This result was obtained early despite a third of the patients entering the trial within the past 6 months and chemotherapies, chemotherapy patients being able to cross over to Libtayo upon disease progression. No new Libtayo safety signal was identified. We are planning to present detailed trial data at a future medical meeting and will complete regulatory submissions in the next few months. And just this morning, we announced that we had identified yet another 1st in class cancer setting where Libtayo as monotherapy exhibited profound and clinically meaningful activity, just as we had previously done for squamous cell carcinoma of the skin, or CSCC, where Libtayo is rapidly becoming standard of care. Our potentially pivotal study in 2nd line advanced Basal cell carcinoma of the skin or BCC demonstrated clinically meaningful response rates of nearly 30% in locally advanced patients who had progressed on prior hedgehog inhibitor treatment.
Impressively, More than 85% of the patients who responded to treatment have experienced durable responses of more than 12 months We intend to submit data to regulatory authorities in the coming months. Basalcell carcinoma presents another promising opportunity to extend our dermatology portfolio beyond the current squamous cell carcinoma indication. BCC is the most common cancer in the world, while only a very small percentage of cases require systemic therapy, The extremely large incidence of this cancer means that there are still thousands of people with advanced basal cell carcinoma in need of treatment. I'd like to frame the significance of these milestones for cancer patients and for Regeneron. In aggregate, our studies have now demonstrated that Libtayo is a potent and effective PD-one monotherapy treatment.
Where we now have the potential subject and very unexpectedly to some, we have now been able to identify 2 found clinical activity based on our studies. 1st, advanced squamous cell carcinoma of the skin and now advanced thasal carcinoma of the skin. Moreover, as Libtayo is establishing itself as a leading PD-one antibody for monotherapy allows us to pursue our strategy of using it studies with our 2 classes of bispecifics, our CD3 class, as well as our CoStim class. That is we have already initiated trial combining Libtayo with our PSMA co slim bispecific to try to endow responsiveness in prostate cancer. And we have also initiated a trial combining Libtayo with our MUCIX team by CD3 bispecific to enhance responsiveness in ovarian cancer.
We are also starting trials combining Libtayo with our other checkpoint inhibitors and with other collaborative assets. For example, we have initiated trial combining Libtayo with our LAG-three antibody to try to enhance responsiveness of first line melanoma where we are also combining Libtayo with various collaboration assets and vaccines. I should note that although all our programs are being impacted by the COVID-nineteen crisis and additional future impacts are difficult to predict. Our bispecific programs, which have been particularly effective, are ones that we are working very hard on to try to continue to enroll. Our potentially pivotal programs for our CD20xCD3 bispecific are enrolling in relapsed refractory follicular lymphoma in relapsedrefractory diffuse large B cell lymphoma and in this setting following CAR T cell therapy.
Failure. We anticipate full enrollment over the next year. And I remind you that we have demonstrated very promising initial efficacy and durability in all of these is continuing to enroll in its proof of concept study where it continues to deliver promising activity as is our MUT16xCD3 bispecific for ovarian carcinoma. Altogether, these are very exciting times for immune oncology here at Regeneron. As we believe we have therapies that are showing important promise as monotherapies as well as the opportunity to combine and match these therapies as is appropriate to enhance and extend the benefit for additional cancer patients in need.
Brief updates on other areas of the pipeline. We are on track to complete our regulatory submissions for Evinacuvant our ANGPTL3 antibody for homozygous familiar hypercholesterolemia patients later this year. Recall in our phase 3 trial, even acumab reduced LDL or bad cholesterol by an impressive 49% in patients not well controlled with other lipid lowering treatments including anti PCSK9s. We are also planning an FDA submission of the data package for Daratumumab, our active NA antibody for fibrodysplasia ossificans progressiva, in the second half of twenty twenty, following dramatic results showing 90% reduction in new bone lesion formation and pending confirmation of these data from the second half of the study. We continue to explore the process of our C5 antibody and the potentially game changing nature of the combination of this antibody with the siRNA program, which we are performing in the compilation with Alnylam.
We continue to move forward with intent on initiating registration studies over the next 12 months. Finally, the opiate crisis continues and the need for alternative chronic pain solutions remain. We are making progress with fasinumab, our nerve growth factor antibody for osteoarthritis pain. We completed enrollment in our Phase III studies last year and we were
healthy demand driven growth of our core brands, Aliyah, Libtayo and Dupixent, while COVID-nineteen began to impact our business in the latter half of March, our first quarter results were strong. I'm going to begin with Eylea performance. Eylea had an impressive start to the quarter with $5,000,000,000 and U. S. Net sales grew 9 percent to 1 $170,000,000 versus the prior year.
COVID-nineteen began to negatively impact ILEA sales with a greater impact from the pandemic on patients with diabetic eye disease then on patients with wet AMD. There was a sharp decline in overall demand in the last 2 weeks of March and 1st 2 weeks of April followed by a sharp rebound in the most recent 2 weeks. Overall, in the month of April, demand was approximately 15% lower than the same time last year, We're encouraged by the recent rebound, although it is difficult to predict future COVID-nineteen impact. Despite these circumstances, we've been extremely impressed with retina efforts to ensure continuity in patient care. Physicians use ADA to preserve the patient's vision because of its breath of indications, dosing flexibility, convenience and safety.
EYLEA dosing can be extended up to 12 weeks in appropriate patients and the recently launched to self monitor vision. We have plans in place to support customers meeting anticipated higher demand for EYLEA once social distancing measures are relaxed. In summary, we're confident that EYLEA can navigate through and grow beyond COVID-nineteen. Turning to Libtayo, 1st quarter global net sales were $75,000,000. In the U S, sales reached $62,000,000 and we continue to extend Libtayo leadership as the number one systemic treatment for advanced cutaneous squamous cell carcinoma or CSC We continue to grow Libtayo and CSCC with nearly 65% of CSCC patients who receives asegment therapy already being treated with an anti PD-one.
In addition to growing the market, we're also capturing more of the therapeutic class demonstrated by nearly 90 We're also closely monitoring the impact of COVID-nineteen on Libtayo, while office visits and chemotherapy administration of decline in general, Liptayo use remains steady and treatment decisions for eligible patients are being made on a case by case basis. Overall, we're proud of our progress with Liptayo. In addition, our team is busy preparing for potential future launches In 2019, the worldwide anti PD-one and PD L1 market was just over $21,000,000,000. In the U. S.
Alone, the 2019 market in non small cell lung cancer was $13,000,000,000, $8,000,000,000 of which was 1st line, with the vast majority of sales still coming from Keytruda. With more than 200,000 new diagnoses of lung cancer in the U. S. Each year, oncologists prefer having a choice in determining the most appropriate treatment for patients. Finally, moving to Dupixent, global net sales in the first quarter were $855,000,000 in the U.
S. Net sales reached $679,000,000, representing 124% growth compared to the prior year. We continue to grow prescribing across all indications, including new to brand patients. In the first quarter, we did not see a material impact of COVID-nineteen on Dupixent sales. In month of April, the rate of new patient starts on Dupixent was impacted due to COVID-nineteen.
Dupixent has several unique competitive advantages that assist physicians in today's challenging environment. It can be administered at home, It does not require laboratory analysis to initiate most new patients and Dupixent is not an immunosuppressant Expected approval of the auto injector in June will provide additional convenience for product administration. Atopic dermatitis remains a significant growth driver for Dupixent. We've expanded prescribing across both moderate and severe disease and the eligible treatment population continues to grow. In the first quarter of 2019 Dupixent was approved in adolescence and we look forward to the PDUFA decision for six to eleven year olds targeted towards the end of May, we have seen rapid uptake of Dupixent and adolescence since its approval, largely largely due to physician experience in older populations, which provides comfort in its efficacy and safety in these younger patients.
In asthma, Dupixent continues to outperform other recent biologic launches. We've seen limited volume impact from COVID-nineteen particularly since medications such as Dupixent are viable for patients to maintain respiratory function, while in early days, the asthma CTC campaign is already generating significant patient interest. Finally, our commercial efforts in chronic rhinosinusitis with nasal polyps continue to contribute meaningfully to the brand. Patients have been initiated on Dupixent regardless of prior surgery since approval And during the COVID-nineteen pandemic, there is an even greater need for Dupixent in these patients due to the limited availability of elective nail polyps surgery. Taken together, we remain committed to realizing the tremendous growth potential of Dupixent through expanded indications, age groups and geographies.
In closing, despite the current circumstances, our brands remain resilient We continue to execute on our strategy and are working diligently to meet the evolving needs of our customers and patients. I'll turn the call over now to Bob.
Thanks, Marion. For the first quarter of 2020, Regeneron delivered solid results on both the top and bottom line despite COVID-nineteen beginning to impact our business operations in the latter half of March. Today, I will first briefly discuss the first quarter results and then conclude with our 2020 guidance. Effective January12020, we implemented changes to our accounting presentation related certain reimbursements and other payments from collaborators. As such, our first quarter 2020 incomparable 2019 financial statements have been prepared under the new accounting presentation.
Pursuant to arrangements with collaborators. Importantly, these changes provide a simplified presentation of our financial results. They do not impact income slide presentation and FAQ on the Regeneron Investor Relations website. Turning now to the results. First quarter 2020 revenues grew 33 percent year over year to $1,830,000,000, driven by continued growth of both EYLEA and Libtayo as well as Non GAAP diluted net income per share grew 48 percent year over year to $6.60 on non GAAP net income of $771,000,000.
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 $682,000,000 representing growth of 2% on a reported basis compared to the prior year. Total Bayer collaboration revenue was $281,000,000, an increase of 7%. We recorded $254,000,000 for us. Total Sanofi collaboration revenue, which under the new accounting presentation consists of our share of antibody profits and reimbursements, for the manufacturing commercialization of non IO antibodies was $171,000,000 compared to a loss of $28,000,000 in the prior period. Driven by higher Dupixent profits.
Effective April 1, 2020, we finalized the planned and prevalent restructuring with Sanofi. In the U. S, Regeneron will have sole responsibility for Craluent and we have begun recording net product sales as of April 1st. Outside the U. S.
Sanofi will have sole responsibility for Praluent and will pay Regeneron a 5% royalty on such net product sales which we will record in other revenue. As for Kevzara, Regeneron and Sanofi continue to assess potential terms of this restructuring following the recently launched clinical program evaluating Kevzara in hospitalized patients with COVID-nineteen. Moving to our expense base and starting with R&D. Non GAAP R and D increased 23% year over year to 527,000,000 driven by advancements in our earlier stage pipeline higher headcount and an increase in clinical manufacturing activities. Next, first quarter 2020 non GAAP SG and A expense increased 27% year over year to 307,000,000 The year over year increase was driven by higher headcount in commercial investments to support the continued growth of our business.
First quarter 2020 non GAAP cost of collaboration and contract manufacturing was $139,000,000 compared to $101,000,000 in the first quarter of 2019 The year over year increase in COCM was primarily due to manufacturing costs associated with higher global sales at Dupixent and manufacturing costs in connection with our BARDA Ebola agreement. Finally, we introduced a new line item called other operating income and expense this quarter. This line item is located within expenses and primarily consists of the recognition of upfront payments in development milestones that were initially deferred and are recognized over time from our collaborators, Sanofi, Teva and Mitsubishi Tanabe. For the first quarter of 2020, we recorded other operating income of $40,000,000 compared to income of $57,000,000 recorded in the first quarter of 2019. Turning now to taxes.
The non GAAP effective tax rate was 9.5% in the first quarter of 2020 compared to 16% in the first quarter of 2019 The year over year decline in the non GAAP effective tax rate was due to increased tax benefits associated with stock option exercises in the first 20 Regeneron generated $528,000,000 in free cash flow. In the quarter, we repurchased $273,000,000 dollars worth of shares in open market transactions. The pace of share repurchases slowed considerably toward the end of the first quarter of 2020 Given the recent share price appreciation, our fully diluted share count that we report for a given quarter is highly sensitive to the average stock price If the average stock price for the second quarter is similar to the current stock price levels, we would estimate that our weighted average share count used for calculating non GAAP EPS for the second quarter will be in the range of 121000000 to 123,000,000 shares. And finally to the balance sheet, We ended the quarter with cash and marketable securities of $7,200,000,000 in minimal debt. Now I'd like to spend a few moments to discuss the financial outlook for the remainder of the year.
We assume that the COVID-nineteen impact on our business will peak in the second quarter 2020. We anticipate a recovery as the year progresses as economies gradually reopen, social distancing guidelines are relaxed and doctor and hospital visits were turn to prior levels. From a supply chain and manufacturing perspective, Regeneron has historically maintained high levels of inventory in the event of a prolonged impact to our manufacturing and production capabilities. Currently, we see minimal disruptions to our supply chain in our manufacturing activities and we have adequate supply of commercial product on hand to meet demand. Our 2020 annual financial guidance reflects our latest assessment of our business in this current environment with limited precision.
Certain elements of our spend will be dictated by the continued severity and length of the COVID-nineteen impact and our efforts associated with Kevzara and our SARs COV-two antibody cocktail. These factors may materially impact our guidance. We will assess carefully whether further updates to our guidance may be warranted. Now moving to our 2020 financial guidance and starting with R and D, we forecast our 2020 non GAAP R and D expenses to be in the range of $1,900,000,000 to $2,040,000,000, we are continuing to invest in our pipeline and research capabilities which remain critical to the Additionally, we are Our R and D guidance also includes the portion related to our COVID-nineteen activities where we will be reimbursed at least in part by BARDA. Unlike R and D reimbursements from collaborations, which are netted in the R and D expense line item under the new accounting presentation, These reimbursements from BARDA will continue to be recorded in other revenue.
Next to SG and A, we forecast our 2020 non GAAP SG and A expenses to be in the range of $1,190,000,000 to $1,290,000,000. We are continuing to invest for product growth now and once the COVID-nineteen impact abate For Eylea, we are continuing to make investments in diabetic eye disease. For Libtayo, launch preparations are underway for anticipated launches in basal cell and non small cell lung cancer. Starting this year, we are providing guidance for COGS and COCM. For COGS, we forecast 2020 non GAAP expenses to be in the range of $295,000,000 to $355,000,000 primarily comprised of U.
S. Eylea, U. S. Libtayo and U. S.
Praluent Manufacturing Costs in the payment to Sanofi for 50 percent of the gross margin associated with U. S. Libtayo. For COCM, we forecast 2020 non GAAP expenses to be in the range of $600,000,000 to $700,000,000, primarily comprised of Global Dupixent, Global Kevzar, ex U. S.
EYLEA, ex U. S. Praluent and Regeneron EB3 manufacturing costs. As a reminder, we are reimbursed for COCM costs Reimbursements are recognized within the Sanofi and Bayer collaboration revenue lines and other revenues. Reimbursements should closely approximate for quarterly reporting periods subject to timing and other considerations.
For the new line item of operating income and expense, We expect this to be in the range of $175,000,000 to $205,000,000 we anticipate our 2020 non GAAP effective tax guidance to be in the range of 12% to 14%. In conclusion, we had a solid start to the year despite initial impacts from COVID-nineteen. Our balance sheet increasingly diversified commercial portfolio and robust pipeline enabled Regeneron to withstand the impacts of COVID-nineteen while making prudent investments in executing on meaningful near term opportunities position Regeneron for sustained long term growth. With that, I'd like to turn the call back
to Justin. Thank you, Bob. Chrisville, that concludes our prepared remarks. We'd now like to open the call for Q And A. Just a word that we have more than 20 callers in the queue, so to ensure that we are able to address as many as possible We will answer
Your first question comes from the line of Evan Seagerman from Credit Suisse.
Quarter. Thank you also for your efforts in combating the pandemic. So with data from both the frontline lung trial last week in basal cell carcinoma today, can you expand as to what's next for your oncology franchise? How do you plan on competing with the standard of care in the frontline lung setting and more broadly across tumor types, amenable to IO therapy?
And I guess that most importantly, as we noted, the loan field is dominated by leading antibody that has produced the most impressive data. We are very excited that our monotherapy trial has delivered data that looks very impressive in terms of the overall survival endpoint. And we have an ongoing combination trial with chemotherapy as well that we're excited about having it readout over the coming year or so. And so I think that this is going to position us well in such a large opportunity where physicians and patients are looking for alternatives. To have an agent that has such profound activity as a monotherapy.
But in addition, we have all these combination programs that I was referring to. We have we believe one of the most exciting homegrown pipelines of additional agents that we could combine to not only, enhance the activity in these settings where the PD-one monotherapies are already active, but also to extend to new settings and new indications such as I mentioned, whether it be prostate cancer or ovarian cancer or others, where right now the activity is not what we would want. So I think that we've put ourselves into a pretty exciting position where we have some of the most exciting agents with identified profound clinical activity as monotherapies, but we now have the opportunity to mix and match these as is appropriate to enhance and extend the activity. So we're very excited about the oncology situation.
Yes. And just to add on the commercial side, it's Lynn. Maybe Marion can chime in. Obviously, we collaborate with Sanofi where we take the lead in the United States. They take the lead outside States, but we work together with them.
And this disease is dominated by lung cancer, maybe marrying a little bit about, well, the numbers, incidence prevalence, what kind of marketplace we're going into?
Yes. So lung cancer is a disease with a very large incident population of more than 200,000 newly diagnosed patients each year. So we do think that there's tremendous opportunity and know that oncologists prefer having a choice in the terminating treatment for their patients. So we're excited about the data and we'll work carefully with Sanofi on lunch preparedness and certainly have built a commercial team that has extensive experience in competitive launches. We look forward to this opportunity if in fact we have an approval for lung and for basal cell.
Thanks, Evan. Next question.
Your next question comes from the line of Geoffrey Porges with with SVB Leerink.
Thank you very much and congratulations on both the surprisingly strong quarter, but also all the progress on the pipeline. George, we haven't had a lot of access to talk to you about the COVID programs. But could you just expand a little bit on the backup program? What its nature is? And the related question of What do you view as the risk of both ADA and also of the antibodies in some way contributing adversely to the inflammatory syndrome in the tail end of this disease?
All right. Yes, those are great questions. So what we were able to generate, because we have these very robust platforms, both the ability to get fully human antibodies from our genetically humanized mouse model as well as from recovering humans. We generated a collection of 1000 and 1000 of antibodies, getting many antibodies that really were at the top end historically at the best level of binders and blockers and antiviral neutralizers that you've ever seen, based on, the literature in the history. And so what we did was we simply selected, several cocktails of the best antibodies where we put them together.
And we created our initial cocktail and a backup cocktail just in case for some reason, something goes wrong with the initial cocktail. So they're actually quite similar. It's just a different collection of antibodies for the backup as well as for the primary. Now, we think that based on the history of treating infectious disease and viral diseases, with highly potent neutralizing antibodies, the risks of things such as antibody dependent enhancement and so forth are actually quite limited. You actually see these, for example, in certain classes of viruses, the flaviviruses, the dengue type viruses and so forth in particular, but that's because of the biology of the viruses there.
With most of the viruses, when you have highly potent neutralizing antibodies, these risks are mitigated. We do have, in addition to our backup collection of antibodies, We do also have our antibody cocktails made with what we call Uber stealth concert regions, which would completely mitigate against that possibility. But for the current approaches that we're taking, we're going to be going forward with fully armed antibodies because we think the risks of ADE with very potent neutralizing antibodies is actually quite low. So I think that the history of antiviral antibodies, our experience the way they worked our own antibodies and other programs, most notably in Ebola, we think that there's a very significant chance that these specifically designed very neutralizing antibodies would all have a significant impact on the disease. We think that There's a great chance that they can be very powerful prophylactic and preventive agents, but we also think that they can treat patients who are already symptomatic with disease And we don't think that right now there's any evidence that suggests that the antibody response is what's contributing to the inflammatory responses in the lung.
And as of course, as has already been seen and described in the disease, the majority of patients do recover and their recovery is coincident with their producing vital responses. So altogether, I think there's a lot of reason to have a lot of hope that this approach really has a chance to make a difference as we said both in prophylactic treatment, but also in treating symptomatic patients.
Your next question comes from the line of Cory Kasimov from JP Morgan.
Hey, good morning guys.
Thanks for the question. Just a follow-up on Jeff's question on the COVID-nineteen front. I'm curious how you're thinking about the clinical trial designs for your antibody cocktail both from a prophylactic standpoint as well as a therapeutic? And on the latter, do you plan to either go head to head or on top of remdesivir if you run initial studies in a hospital setting? Thank you.
Well, we planning on doing 3 sets of trials in the prophylactical prevention setting in people who are at high risk in early treatment that is patients who are not at the level that they would be normally hospitalized. For patients who are identified, they're symptomatic, if they do go to an ER, they're sent home, but they don't need oxygen support. However, significant number of them do develop more serious disease and then have to return to the hospital. So the idea would be to stop the disease in those individuals and stop the progression and the need for them going back to the hospital. And then we're also going to go to the hospitalized setting, very similar to what we're doing with Kevzara, and where Roomdesivir data has read out.
So certainly, the only setting where it would be on top of an existing standard of care potentially would be in the late treatment setting. We would certainly be going on top of standard of care there. Whether it be remdesivir or maybe we'll see whether there's data from other agents by that time as well. In the prophylactic setting, There's no need and there's also no other standard of care, and in the same thing in the early treatment. And I would remind you once again that based, as I said, our experience in other programs and most notably a good example is the Ebola program, the earlier that one treats The better one does.
And I remind you, early in the disease for Ebola, which is obviously a much more lethal disease with much higher levels of severe disease and death, we're able to saved more than 90% of the patients when we went with early treatment. So I think that there's a lot of reason to think that in this setting, These sorts of antibodies both in the prophylactic setting and in the early treatment setting can have really profound benefits on their own.
Thank you for the question Corey. Next.
Your next question comes from the line of Tim Anderson from Wolfe Research.
Thank you very much. On your antibiotic cocktail, I'm wondering if you think Gilead's act with remdesivir essentially kind of set the bar for other companies in terms of what they may be expected to do specifically in terms of giving away some portion of initial therapy free at the outset.
So thank you.
Glenn, you want to take that?
Lynn?
Yes. Hi, sorry. It's Lynn. We've spent all of our energy right now focused on getting the technical success that George described and that we hope to see. And in parallel, we have been working to clear manufacturing capacity in our New York plants so that we can make it at large scale We hope to be able to have a couple 100,000 doses by the end of the summer and then continue to factored from there.
In terms of pricings donations and fair values and all that sort of stuff, that's just got to come down the road a little bit.
Thank you. Next question.
Your next question comes from the line of Ronny Gal from Bernstein.
Good morning, and thank you for taking my question. I want to go back to Libtayo non small cell lung cancer. I hear you about physician wanting to have a choice in monotherapy, between Keytruda and the second product. My question is, why should they choose Libtayo to Keytruda. I think you've got a product here, which is just to make a point, a few years with the sense of care, you use extensively Can you just share with our senior data?
Is there other elements of the data you were seeing from the trials? It would suggest that there is any group of patients where physician should prefer Blue Sky OIBDA. What is your marketing argument here? And before I stop that, I just want to thank you all the efforts you're making against COVID-nineteen, just adding to my peers here.
Thanks, Ryan. It's Lynn. It's way too early for us of making any comparative statements. We've literally just recently got the good news from the data monitoring committee that we met with highly statistical significance, as George described, survival. We've got a lot more days to go.
We've got a lot more studies to look at. It's not just one study. It's not just the cross study comparison. There's going to be a lot more that goes into this. And we'll just have to see how this evolves, but the history of the industry typically is that if there's just a couple of competitors You have to remember that the size of this market last year was about $22,000,000,000 which about 70% or 75% was lung cancer and that was largely driven by KEYTRUDA sales.
So there's a pretty big opportunity to have some important alternatives and you'll just have to wait. I'm sorry, I wanted to see how this all evolves and we roll this out.
Your next question comes from the line of Chris Raymond from Piper Sandler.
Just back to the antibody cocktail, I guess. So, George, a lot of folks, I guess, close to the FDA and maybe some a fairly loud voice on these COVID matters. So I keep talking about at least one of the therapies, one of the antibody therapies and development being available as early as this fall. So I guess maybe just talk about how is that possible from a clinical development standpoint and especially in light of the program you just described, George, with the 3 different settings, obviously when there's something that's even under an emergency use authorization available, how do you deduct that? Thanks.
Well, yeah, I think that these are all great questions. We're in unprecedented times. I think that the urgency and the collaborative spirit between regulators, between medical institutions, between companies, has never been seen before. And also our commitment to this is something we've sort of done it before, but now we trying to take it to the next level. So we are planning, as we said, in June to simultaneously initiate trials in the three settings that we're actually talking about, we are thinking of ways to synergize between the three classes of trials that we're talking about.
And we are hoping. I mean, this is going to depend on a lot of factors and there's obviously a lot of risks and concerns whether this can be done since it hasn't ever been done before, but we are really hoping that we'll be able to not only initiate these studies, but able within a month or 2 to perhaps if these agents are working as well as we might hope they would work as well as, for example, some of the precedent sent by Ebola suggests that they might work that we might within that month or 2 be getting data. If we were to get data within those sort of time frames, as Len describes, we have already committed at risk to manufacturing a drug supply that could be providing by the end of the summer 100100 of 1000 of doses of these antibodies. So, you're right. It's never been done before.
On the other hand, I don't think we ever had quite a pandemic like this before. And I think that some companies like ours, have really put themselves in a position with the technologies, the commitments the investments that we've made to put ourselves in a position to maybe help out and make a difference here. And regulators like the FDA, BARDA, everybody is coming together to try to help us in this situation to meet the urgency and meet the dire need that we might have here. And so the hope is, yes, it might be possible by the end of the summer or the fall that our antibody treatment could be available. A lot of risks, a lot of concerns, but we are working as hard as we can with so many collaborators to try to turn that into a reality.
So we still have several callers sorry, we have several callers still in the queue. So we'll extend for a few more minutes if we can.
Let me just put a final point on that for just a second. Agree with George. And I think if you listen carefully to what he was saying is that because we're doing 3 different types of studies, the timing on the different studies might be quite different. If you're dealing with people, who are already have disease, then you're not waiting for that long period to occur. When you're trying to prevent the disease.
And people who already have the disease, the course of the disease sort of declares itself over a several week to month period. And so you could imagine, depending upon what's going on, how many people are actually showing up at the hospital, how many people are hospitalized in this ICU, that that part could go a lot faster. But of course, you can imagine that George and the team have got a lot of great strategies for the early part to try and find people at high enough risk, which is the hard part in a preventative setting. Sorry, next question.
Your next question comes from the line of Terence Flynn from Goldman Sachs.
As well for me for all your efforts on the COVID front. Maybe another one for George on bispecifics. I was just wondering if you've already generated data from your PSMA bispecific antibody as monotherapy. And if that's what led to your decision to initiate a combo trial with Libtayo. And then the second part of the question relates your comment, George, about seeing continuing promising activity.
I was wondering if that was only on the BCMA bispecific or if that also covered the 16 bispecific? Thank you.
Yes, great questions. I guess, first of all, Basically, we think that the bispecific co stems We've described these in the literature. We have a lot of data on them. On their own, they are designed to essentially have very little or no activity. And only when combined with either a CD3 bispecific or with the PD-one agent do they then essentially synergize and amplify the benefit or activate the benefit of the other agents?
And we've done a lot of work on that. Quite a bit of published work has already been shown on that. And the early data in the clinic are supporting that in that the monotherapy cost in was not intended and did not show single agent activity. We are now in the combination program where we are hoping to now activate activity by adding the coast in to the PD-one. That's how they were designed.
That's what we're hoping to see. And that is what we're hoping to be able to generate data that we will be giving you information on in the future. In terms of the promising activity, I think that yes, we have seen robust activity with the BCMA We have not really reported anything on the MUC16. I can say that we are seeing evidence of activity and we'll give you more details on that in future times.
Thank you, Terrance. Next question.
One second, if I may. We appreciate all the comments from the analyst community. Thank you for what we're doing. We just want to say we find your notes very useful and very helpful. The coverage of this pandemic the useful information that all of you provide and what's going on and what the rates are of this and that and what to be expected we really appreciate that as well.
Your next question comes from the line of Josh Schimmer from Evercore ISI.
Great. Thanks for taking the question. Another one on COVID-nineteen. How do you determine the optimal dose passive immunization, especially if you have to adjust for different levels of exposure, how long do you think a single dose will confer protection and then what are real goals in terms of the number of people you can support beyond August with prophylactic use considering potential supply constraints? Thank you.
Okay. Well, basically, we have accumulated over many years now A lot of understanding about the doses that one needs to block viral infection, particularly of respiratory and other diseases. So we actually know both in animal models and in humans the blood levels to block respiratory infection. And so we are targeting to be significantly above those blood levels for a minimum of at least a month for the prophylactic setting. So there's no guarantees once again these are all predictions based on experience and in other programs with other viruses, but including, for example, the virus coronavirus.
And so we believe we have a good target blood level that we need to meet and achieve and stay above on for at least a month for the prophylaxis setting. And so the prophylaxis dosing is intended to last for at least a month For example, in our RSV program, for 1 of our programs there. We were able to have protection for several months. So minimum of a month is our current target based on maintaining blood ups that we believe you have to maintain above for preventing infection by respiratory viruses. What was the rest of the question?
In terms of supply, yes, I'll take that to it. Thanks. In terms of supply, we've COVID as fast as we can. We have an amazing capability and technology that allows us to get high producing cell lines very rapidly. We know how to make antibodies.
We are one of the companies that can do this from end to end seamlessly. And so, I'm optimistic that we can expand from the initial numbers we talked about and continue to manufacture. We have had inquiries from multiple other companies about perhaps wanting to manufacture cocktail when we have good data and we suspect maybe the government may want that to happen as well where we can expand through collaborative efforts and to take the unprecedented step of letting some of our technology outside the company for this purpose as well, because that's what probably will need to be done.
Thanks Lynn. Next question.
Your next question comes from the line of Yaron Warker from Cowen.
I'm going to shift a little bit George maybe Fasinumab, just so we don't lose track of that program. It sounds like that data is coming up pretty soon in the Phase III osteoarthritis data. Any thoughts and any thoughts on Pfizer files for nexumab for approval? So this is totally overlooked, but I want to know what's kind
of coming down as you can share. Thank you.
Yeah. Our viewpoint with Vicinumab is that for a long time now as obviously I think most people appreciate is that in many ways, this is a very risky program in that there are there is a now well defined adverse event, that we are trying to tighter around with the dose. And I think the major question for this program is whether we have been able to find a dose that threads the needle between this safety concern and between providing sufficient benefits to patients. I think if you see other competitors data here, it's been a little difficult for others to thread the needle. So this is what we're going to see, especially when we see the data that comes out from our ongoing program that we'll be getting by the middle of this year.
How well we've done to actually find a magic spot on the dose response curve where we have sufficient safety, but sufficient benefit and how that might compare to what others have achieved. So we are as anxious and excited as you are to see whether we may have threaded this needle in a way that really provides an important alternative 4 patients. As we know, there is a crying, literally a crying need here, for new pain medications and particularly for the osteoarthritis population and we are hoping that we may have threaded that needle.
Thanks, Jerome. We're going to try to cut the call about core to the hour that leaves us with time for 1 to 2 more questions. Next question, Krystal.
Your next question comes from the line of Carter Gould from Barclays. Great.
Good morning. Thanks for taking the question and pass on my congrats on the Libtayo data sets and thank you for all the COVID efforts. Maybe just focusing back on Libtayo for a second. It sounds like most of the commentary sort of reaffirmation of the development strategy here and sort of validation of the efforts today. I guess I guess, but with this data in hand, particularly the lung data, does this sort of either accelerate your focus on brought further broadening out of the novel novel combinations or potentially a shift to bringing in outside agents, maybe a shift in sort of that partnership strategy.
Thank you.
Right. I think that this is really a landmark for the field, but also for us. KEYTRUDA has stood really unchallenged now particularly in lung cancer, which is driving most of the sales for this entire field. Because others haven't actually been concerns about people talking about how are you going to compete. But having something that's already showing profound clinical activity that we're now seeing as a monotherapy with also having also identified this is another thing that people have to appreciate new first in class indications that had been missed by the rest of the field.
1st with cutaneous squamous cell carcinoma and now with basal cell, I think our establishing Libtayo as a legitimate monotherapy alternative. And as Len said, when you have opportunities such as $8,000,000,000 opportunities in 1st line history three shows that bonafide, competitors with profound clinical activity, they are going to get significant shares. But I think it's exactly, as you said, we believe we are now in a position where we can compete in these monotherapy situations but it only amplifies our excitement and And of course, as you say, we are working hard to find the right outside collaborators. And I think we've already announced quite a few of them that we're very excited about, that we're already starting combination studies on and so forth. But we are just as excited about our internal homegrown pipeline.
We have been preparing a series of combination assets just for this moment now where we will have this potent powerful PD-one antibody of our own. Our entire strategy dependent on it and now that the molecule has come through and proved that it really is a bona fide monotherapy competitor out there, we are now just doubling motivated and compelled to now build upon that with all these combination opportunities that have been coming out of our labs for the last few years. So we could not be more excited that we will now have the ability to not only compete as a monotherapy now to add with all these combinations, all these bispecifics, the coast and bispecifics and so forth, as well as these collaboration assets. And we think this is a really exciting time, not only for us, but for the field. Because I hope you all realize how the immuno oncology field despite all the initial excitement has not moved forward as much as I think we all would have wanted it to have moved forward.
We haven't seen the magic combinations. We haven't seen the dramatic increases into new cancers. We think we have the opportunity to take that field to the next level and having the foundational PD-one antibody of our own really gives us that opportunity. So these are really exciting times for us, but I think for the field that For the first time in a decade, maybe substantial new advance or new age of immuno oncology may be coming now.
Quick questions.
You can be sure we're getting together with our collaborative sanofi on this and kind of look carefully about how to move forward and how to compete well with the data we have and other data we want to get.
Your next question comes from the line of Geoff Meacham with from Bank of America.
You. Just to follow-up, George, I'm putting your earlier comments about rolling out efficacy studies next month. I'm assuming that or can I infer that you're bypassing traditional phase 1 safety studies and healthies? And then when you think about manufacturing scale up, what's the opportunity to outsource or to partner should you have much higher demand and success obviously in the pivotal study? Thank you very much.
Yes. I think that we have been already in active conversation with regulators exactly on the points that you talk And I think these are unprecedented times. And I think also when you have the history with these types of agents It does allow you and it does allow the comfort of the regulators that one could be moving forward very quickly. And so, as you might imagine, along the lines of things that you propose. These are exactly the sorts of things that we're talking about with regulators and we're trying to employ into our designs.
In terms of your second part of your question, I think Len already started talking about this point, which is we have made a huge commitment to enable our entire upstate New York Manufacturing facility to be devoted to this effort, which on its own could supply 100 of 1000, if not over the course of time, maybe even on the order of a 1,000,000 or so doses per month. However, even that might not be sufficient depending on the demand, depending on whether there's a second wave, depending on what happens with vaccine and so forth. So, we are actively talking about collaborations with others who are very interested in bringing their resources to the table here too. As we said, there's enormous collaborative spirit that I think we haven't seen before between companies to come together, to help each other out, to really make a difference here in this pandemic. And so that opportunity is really out there.
We're actively talking with people. And of course, it all depends on whether these antibodies deliver. But if they deliver, And depending on the state of the pandemic, if there's more need, I am sure that there will be ways that either we on our own or with major collaborations we'll be able to supply more, to more patients.
Okay. Chris, the last question unfortunately, we have a lot people still in the queue, but this will be our last question.
And your question comes from the line of Yatin Sanja with Guggenheim.
Good morning, everyone, and I also appreciate all the efforts on the COVID front. I also would like to compliment Bob for simplifying the accounting really appreciate a much cleaner guidance that you provided today. So the question is on the EYLEA front. I think Maryann, a pre COVID you were anticipating total market supplier for peak also in by March. Could you comment where you are in terms of the supply of PFS and any impact that you saw of PFS and IVF performance in 1Q?
And also, I'm not sure if there was any inventory dynamic that you commented on IVR today?
Okay, so sure. Let me take this. I'll start with your last So in terms of inventory, we have stayed at normal levels. So we're not seeing any, anything unusual in terms of inventory. Your next question on prefilled syringe.
We do think prefilled syringe is a very attractive alternative in the marketplace. And the use of the prefilled syringe has gone up to about 75% of total use of EYLEA. We have, as you know, introduced prefilled syringe in a staggered way starting towards the end of last year, but it's been very well received and we do intend to have not only prefilled syringe, which of course is growing in popularity, but will also maintain vials in the marketplace. And then I believe the other item that you were commenting on was in terms of the COVID impact. And as I shared, Certainly in the first quarter, we had very robust performance with EYLEA and saw our sales grow in the U.
S. Market 9% in net sales over the prior year. We did see, as I mentioned, a decline in overall demand in the last 2 weeks of March and that continued into the 1st 2 weeks of April, then we saw a sharp rebound in the most meaning a positive trend in the last 2 weeks so that when you put all that together and all those factors together, demand in the month of April was But I go on to say it's hard to predict what will happen with the COVID impact going forward, but we remain very confident in Eylea's profile our commitment to the retinal specialist community and the obviously the very attractive profile we have both clinically and from a safety standpoint with Eylea. We're supporting our offices through appropriate promotion and support so that when patients flow returns in a more robust fashion, we certainly look forward to the opportunity to help those patients with EYLEA and support our prescribers.
Thank you everyone. That's going to conclude our call. We appreciate everybody hanging on a little longer today given, all the things that we had to speak to and all the great questions that came in. Bob Landry and the IR team will be available following the call to answer further questions.
Ladies and gentlemen, this concludes today's conference. Thank you for your participation and have a wonderful day. You may all disconnect.