Q1 2020 Earnings Call

[music].

unknown: BF-WATCH TV 2021

Operator: Good morning, my name is Lisa, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Biogen first quarter 2020 financial results and business update. All lines have been placed on mute to prevent any background noise.

Operator: After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star, then the number 1 on your telephone keypad. Please limit yourself to one question to allow other participants time for questions.

After the speaker's remarks, there will be a question and answer session. If he would like to ask the question. During this time simply press Star then the number one on your telephone keypad.

Please limit yourself to one question to allow other participants time for questions. If you require any further follow up he may press star one again to rejoin the queue. Thank you I would now let's turn the conference over to Mr., Joe Moore, Vice President Investor Relations you May begin your conference.

Joe Marra: If you require any further follow-up, you may press star 1 again to rejoin the queue. Thank you. I would now like to turn the conference over to Mr. Joe Marra, Vice President, Investor Relations. You may begin your presentation. Good morning and welcome to Biogen's first quarter 2020 earnings call. Before we begin, I encourage everyone to go to the investor section of Biogen.com to find the earnings release and related financial information. Including a reconciliation of the GAAP to non-GAAP financial measures that we will discuss today. Our GAAP financials are provided in tables 1 and 2. And Table 3 includes a reconciliation of our gap to non-gap financial results. We believe non-gap financial results better represent the ongoing economics of our business and reflect how we manage the business internally.

Good morning, welcome to Biogens first quarter 2020 earnings call before we begin I encourage everyone to go to investors section of margin Dotcom funny earnings release related financial peers, including a reconciliation of the GAAP to non-GAAP financial measures that we will discuss today, our GAAP financials are providing tables one to the table.

Green goods, a reconciliation of our GAAP to non-GAAP financial results, we believe non-GAAP financial results better represent the ongoing economics my business and reflect how we manage the business internally.

Joe Marra: We've also posted slides on our website that follow the discussion related to this call. I would like to point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional details. On today's call, I am joined by our Chief Executive Officer, Michelle Venazos, Dr. Al Standrock, EVP, Research and Development, and our CFO, Jeff Capello. Now, I will turn the call over to Michelle.

Also posted slides on our website following discussion related to this call.

I'd like to point out that we will be making forward looking statements, which are based on our current expectations or beliefs. These statements are subject to certain risks and uncertainties in our actual results may differ materially I encourage you to consult the risk factors discussed in resi filings for additional detail on today's call I'm joined by our Chief Executive Officer, Michelle been Oxos Dr. Al Sandrock.

D P research and development and our CFO, Jeff Capello now I will turn the call let me show.

Michelle Venazos: Good morning everyone, and thank you for joining us. I want to first acknowledge the challenging situation the global COVID-19 pandemic has created for so many people. Our hearts go out to everyone who has been impacted. We applaud the way our employees and everyone across the entire healthcare system are breaking down barriers and working together to address this pandemic. And we are committed to doing our part to support communities worldwide. But at the same time, we are also committed to learning from the current situation and working to develop innovative new operating models, such as accelerating our digital capabilities, which we believe will better position Biogen for the future. During these challenging and unprecedented times, Biogen's mission and purpose remain the same. Over half a million patients around the world rely on us today to supply important medicines for serious diseases, and there still remains an urgent need to develop innovative therapies for the millions of patients suffering from devastating diseases of the nervous system.

Good morning, everyone and thank you for joining us.

I won't supposed to I've known edge the challenging situation. The global coffee 19 pandemic has created well. So many people Oh helps go out to everyone who has been impacted we applaud the we I will employees and everyone across the entire healthcare system is breaking down by reuse and working together to address you spoke.

They make and we are committed to doing I with bolt to Shapell communities worldwide. At the same time. We are also committed to learning from the current situation and working to they've lucky nobody even knew approaching what else such as accelerating or would you do you took a baby <unk>, which we believe we better position biogen for the future.

During these challenging and unprecedented times Biogens mission and purpose remain the same.

How's the median patients around the world rely on us today to supply in Bolton committed seems we'll show you just diseases and there's still remains and I'm sure urgent need to develop nobody's therapies for the millions of patients suffering from devastating diseases of the nervous system.

Michelle Venazos: Let me now provide you with an update on how we are operating our business throughout the pandemic. First, I would like to recognize the resilience and adaptability of the Biogen team. Biogen personally felt the painful impact of this global crisis as many of our employees became sick early on, and others have since been affected. We have been fortunate that, as of today, all of our employees have recovered or are recovering. Most of our affected employees have continued to work and fulfill their duties. We are grateful to the public health authorities for all they have done, and we are also thankful for the courage and compassion of the health care workers who have been helping us and continue to support so many.

Let me know provide you with an update on how we are operating our business while the pandemic.

First I would like to recognize the resilience and that the adaptability of the Biogen team.

Biogen personally failed to paint what impact if he's got about crises as many of our employees became seek early on and orders have since been affected.

We have been fortunate that as of today all of our employees have we called it recovered all are recovering.

Most of our affected employees have continued to work and food feed the duties.

We are grateful to the property cat so three keys for old they have done and we are also thankful for the courage and compassion over the healthcare workers quite been helping us and continue to see bought sold many.

We do in number of actions early on to she bought that was stakeholders and society at large including.

Michelle Venazos: We took a number of actions early on to support our stakeholders and society at large, including Committing $10 million from the Biogen Foundation to support global response efforts, launching a consortium with the Broad Institute of MIT and Harvard and Partners Healthcare to build and share a biobank, and giving Biogen employees who have recovered as well as their close contacts the opportunity to donate samples and medical data. They are pursuing a process development and manufacturing collaboration with VEER Biotech, which is developing potential antibody therapies for COVID-19. Providing Medical Equipment and Supplies to Partners Healthcare in Massachusetts and Developing and Donating 3D Printed Personal Protective Equipment in Massachusetts and North Carolina. Engaging with investigators who may want to evaluate the potential of our interferon therapies or our anti-TNF biosimilars to treat COVID-19. Facilitating volunteers' efforts by our medically trained employees to serve as health care workers on the front lines and by other employees to serve the community; and Implementing Policies and Practices to Safeguard Our Employees and Communities, including asking almost all the employees to work from home at this stage.

Well meeting $10 million from the Biogen Foundation to support to global response efforts launching equal so should we the broad in sheet yourself. It might you have evolved and partners health care to build and share a bio bank and giving Biogen employees why do we covered as well as the close contacts the opportune.

And seek to donate samples and medical data.

Pursuing it process development and manufacturing collaboration we fear biotech, which she did not being potential antibody to therapies for Cobiz 19.

Providing medical equipment and supplies to partners has carried in Massachusetts, and they've looked being and donating threed printed best when I put their TV equipment in Massachusetts, and North Carolina.

Engaging with investigators who may want to evaluate the potential of our industrial therapies or anti TNF, but you'll see me love to treat Cobiz 19.

Facilitating volunteers it falls by or maybe you could you try and I'm pleased to serve as healthcare workers on the fault lines and by all downplay used to serve the community.

And implementing policies and practices to save Gotta will employees and communities, including asking almost all the I'm pleased to work from home at this stage.

Michelle Venazos: These are our initial commitments, and we will continue to look for additional ways to help. At the same time, we have remained intensely focused on operating our business to serve the needs of all our patients and stakeholders. I am proud to see the Biogen team demonstrate agility by quickly defining innovative approaches to both mitigate risks and identify new opportunities across R&D, manufacturing, medical, and commercial operations. Let me provide you with an update on several key areas of our business. At this time, our supply chain around the world is functioning well.

These are our initial commitments and we will continue to do additional ways who has.

At the same time, we had remain intensely focus on old breaking out with business to serve the needs of all know what patients and stakeholders.

I am proud to see the Biogen team demonstrates a GDP by quickly defining you know, but youve approaches to both Mickey good risks and identifying new opportunities across R&D manufacturing medical and commercial operations.

Let me provide you with an update on several key areas of our business.

At this time I was supply chain around the world is functioning when.

Michelle Venazos: We continue to operate our manufacturing facilities and are working with organizations across our supply chain to maintain continuity, and we continue to closely monitor the evolving situation. We are carefully considering recent regulatory guidance on conducting clinical trials during the pandemic, and the safety of participants in our clinical programs is our top priority. To help mitigate the impact on our clinical trials, we are pursuing innovative approaches, such as remote monitoring, remote patient visits, and supporting home infusion. While we expect there may be some impact on timelines for some of our clinical programs, importantly, we still expect the vast majority of the 10 remaining readouts we have recently highlighted to occur before the end of 2021. We have continued to have frequent interactions with regulatory authorities, including for ad eucanumas. We have adjusted our commercial and medical affairs operations and accelerated our digital engagement with customers. We are working with regulators to enable home infusions for Tysabri where appropriate.

We continue to operate our manufacturing facilities and are working with organization across our supply chain to maintain continuity and we continue to closely money told the evolving situation.

We are carefully considering recent regulatory guidance on conducting clinical trials drink the pandemic and the safety of participants you know what can you could pull times is our top priority.

To help mitigate the impact slow clinical trials. We are pursuing you know about you've approaches such as remote monitoring remote patient visits and supporting home intrusions.

Well, we expect that may be some impact to timelines for some of our came through pulled times importantly, we still expect the vast majority of the den remaining read outs. We have recently highlighted to occur before the end of 20 to 21, let's take a moment.

We have continued to have Frank frequent interactions with regulatory authorities, including educating them up.

We have adjusted our commercial and medical Affairs operations and accelerated I would you just got engagement with customers.

We are working with regulators to enable a home intrusions for tysabri where appropriate.

Michelle Venazos: To date, our business and financials have remained strong. We believe that we are in a strong position to remain the leader in neuroscience based on the strengths in our core business areas, a healthy balance sheet and financial position, and a robust pipeline across several important disease areas. We continue to believe we have multiple opportunities for significant near-term value creation as we aim to build a multi-franchise portfolio in areas such as Alzheimer's, ALS, stroke, ophthalmology, and lupus. Now, let me turn to the highlights of the first quarter, starting with our financials. First quarter revenues grew 1% to $3.5 billion, and first quarter GAAP earnings per share grew 13% to $8.08. And non-GAAP EPS grew 31% to $9.14. Now, turning to our progress across our strategic priorities. First,

To date, I would business and financials have remain strong.

We believe that we're going to strong position to remain did either you know science based on this trends you know with coal business areas, a healthy balance sheets and financial position and a robust pipeline across several important disease areas.

We continue to believe we have multiple opportunities for significant Newton value creation as we aim to be lead me to franchise portfolio in areas such as Imas a less.

All of sudden motor Gi and lupus.

Now, let me turn to highlights over the first quarter, starting we'd always financials.

First quarter revenues grew 1% to $3.5 billion first quarter GAAP earnings per share grew 13% to eight the allows an eight cents and non-GAAP EPS grew 31% to $9.14.

Turning to our progress across I was talking cheap priorities first.

We have made good progress towards the regulatory filing in the U.S. <unk> as you can you map. We have continued to have constructive engagement with the U.S.M.D.. We now have an open BLE and we have started to seven modules offered the filing we.

Michelle Venazos: We have made good progress towards the regulatory filing in the U.S. for aducanumab. We have continued to have constructive engagement with the U.S. FDA. We now have an open BLA, and we have started to submit modules of the filing. We have participated in additional formal interaction using mechanisms such as type C meetings, and we are preparing for a pre-BLA meeting currently scheduled for this summer.

I have participated in additional for money direction using mechanisms such as type C meetings, and we are preparing for a pre BLE meeting currently scheduled for the summer. Following that's meetings, we expect to complete the filing in Q3.

Michelle Venazos: Following that meeting, we expect to complete the filing in Q3. I'd like to thank the FDA and the aducanumab team at Biogen who have adjusted to working under the current circumstances with COVID-19, in particular, as some members of the Biogen team were directly impacted. Outside the U.S., we have had initial ad hoc discussions with regulators in Europe and Japan, although these interactions are still in the early stages. In March, the first patient was those in the AMBAC Redosing Study, which aims to provide access to aducanumab for eligible patients previously enrolled in our aducanumab clinical studies. While we collect important data in this study, we do not believe it is required for the filing.

I'd like to thank the ft, and educating met team I'd Biogen will have adjusted to working under the current circumstances, we copied 19 impact she color I. Some members over the Biogen team would directly impacted.

Outside the U.S., we have had initial I'd you couldn't imagine discussions with regulators in Europe, and Japan, all <unk>, although these interactions I sealing the early stages.

In March the first patient was those India and Buck reducing study, which aims to provide access to educate you mad for eligible patients previously enrolled.

Any American Eagle studies.

Why did we collect important they starting B study, we do not believe it is required for the filing.

Michelle Venazos: From a manufacturing standpoint, we currently expect to have adequate supply to meet anticipated demand for adjucanumab, initially using our facility in RTP, North Carolina, which will later be complemented by the large next-generation, state-of-the-art facility we are building in Southern Switzerland. The construction of that facility is complete, and its validation remains on track. We expect it to be operating by the end of this year and to be producing some of the commercial supply of aducanumab in mid-2021. Together with our collaboration partner, SI, we remain optimistic about the prospect of bringing aducanumab to market as the first therapy to reduce clinical decline in Alzheimer's disease. And we continue to progress in our market preparation and launch readiness with an initial focus on the US. We hope that aducanumab marks the This includes BAN24-1, which we are collaborating on with SI. Multiple programs targeting Tau allow our collaboration with CAMP4 to identify new drug-able targets. Our acquisition of a CK1 inhibitor from Pfizer as a potential symptomatic therapy and our new collaboration with Sangamo to develop gene regulation therapies for a range of neurological indications, including Alzheimer's disease.

From a manufacturing standpoint, we currently expect to have adequate supply to meet anticipated demand for educating them up initially using other facilities RTP North Carolina, which we later would be complemented by the large next generation state of the Alpha facility, we are building sort of sense.

Turning the.

The construction of that facility east complete any to validation remains on track, we expect it to be operating by the end up this year and to be producing some of the commercial supply of education mob in mid 2021.

Overhaul.

Together with our collaboration partner its size, we remain optimistic about the prospect of bringing educating about two markets as the first therapy to reduce clinical decline in Alzheimer's disease, and we continue to progress you know what market preparation.

[noise], sorry, [laughter] sorry.

And launch readiness. We then initial focus on the U.S.

We hope that I'd you can imagine marks the beginning of an era of new potential treatments ones I missed disease, and we aim to build it brought franchise across multiple targets and modalities.

This includes pardon Ttwenty four one which we are collaborating on we'd ESI multiple programs targeting though I look our collaboration that we've come for 25, new Druggable targets.

Accretion of the Schicchi wanting to be to from Pfizer as you put on chart symptomatic therapy, and our new collaboration we the sangamo to develop aging regulation therapies for a range of now what did you call indication, including Alzheimer's disease.

Second.

Michelle Venazos: Q1 MS revenues, including Ocrevus royalties, were $2.3 billion, an increase of 9% versus the prior year. The number of patients on our MS products globally increased 3% versus the prior year, and our business continued to demonstrate resilience. We continue to launch Vumerity in the U.S. We have been able to secure unrestricted access for Vumerity faster than other recent competitive launches. We have also been pleased to see that a large proportion of Umeriti patients have come from therapies other than texfidera, and approximately 30% of Umeriti patients are naive to treatment.

Q1, M.S. revenues, including all criticize loyalties was $2.3 billion, an increase of 9%, but she's a probably or the number of patients on our M.S. products globally increased 3%. This use of prior and our business continued to demonstrate resilience.

We continue to launch of you may recall in the U.S., we have been able to secure and restricted access will be memory T faster than other recent competitive launches. We have also been pleased to see that too large proportion of the memory T patients have come from therapies older than decreed era and approximately.

30% of him every key patients and I used to treatment.

Michelle Venazos: We also made progress with our first ex-U.S. regulatory filing for emeriti in Israel and plans to pursue approval in other major markets worldwide. We were pleased that the claims of our Tecfidera patent were upheld by the U.S. Patent Office in a positive decision on the IPR challenge. This decision has been appealed and is pending. We expect decisions from the Federal District Courts in Delaware and West Virginia and their actions later this year.

We also made progress with our first ex U.S. regulatory filing of who maybe T in Israel and plans to push you approval in older major markets worldwide.

We were pleased that the claims offer with decree there right, but that's what upheld by the U.S. patent office in a positive decision on the IPO challenge.

These decision has been appealed to any spending we expect decision from the Federal District Court ended that aware and West Virginia and actions later this year.

Third Spinraza generated first quarter global revenues of $565 million in 9% increase the she's the probably your and 4% increase let's use the prior quarter, including the expanded access program.

Michelle Venazos: Third, Spinraza generated first quarter global revenues of $565 million, a 9% increase versus the prior year and a 4% increase versus the prior quarter. Including the expanded access program and clinical trials, over 10,000 patients are being treated with Spinraza. This quarter, important new data were published showing the clinically meaningful benefits Spinraza can deliver for teens and adults with SMA, and we initiated a new study to evaluate the potential for even greater efficacy with a higher dose of Spinraza.

In clinical trials over 10000 patients being treated we spinraza.

This quarter important data were published showing the clinically meaningful benefits spinraza can de lever for teens and others.

We'd estimate and we initiated a new study to evaluate the potential for even greater if he can see we the higher dose of Spinraza.

Michelle Venazos: Fourth, our first quarter biosimilars revenue was $219 million, which represents 25% growth year-over-year. We estimate that our biosimilars generated approximately 1.8 billion euros of savings to the European healthcare systems in 2019, which we expect will continue to increase in 2020. This is critical as we work to create financial headroom for innovation and continue to contribute to the long-term sustainability of the health care system. Finally, beyond Alzheimer's disease, we continue to develop and expand our pipeline. In particular, this quarter, we submitted regulatory filings for an intramuscular formulation of PLEGR-E-T in the U.S. and in Europe, which may be another important option for MS patients.

Well.

First quarter, but you'll see me das revenue was $219 million, which represent 25% growth year over year. We estimated that there would that you'll see me das generated approximately 1.8 billion euros of savings to the European healthcare systems in 2019, which we expect we continue to increasing twentytwenty.

This is critical as we work to create financial headroom for innovation and continue.

And contribute to the long term sustainability of the healthcare system.

Fish.

Beyond that Simon's disease, we continued to develop and expand our pipeline in particular this quarter, we submitted a regulatory filings when in Tommy screwed up formulation of liquidity in the U.S. and in Europe, which may be another important option for M.S. patients.

Seeks our cash flow generation remains strong and continue to provide us with significant optionality and flexibility to look at capital.

Michelle Venazos: Our cash flow generation remains strong and continues to provide us with significant optionality and flexibility to allocate capital. In Q1, we generated approximately $1.5 billion in cash flow from operations. We continue to have the financial flexibility and capacity to evaluate potential external business development and M&A opportunities and remain active on the business development front. As we have demonstrated in the past, we are committed to maximizing returns for our shareholders while continuing to bring innovative therapies to patients. This demands a thoughtful approach towards all our investments over both the short and the long term. In summary, despite the challenges due to the COVID-19 pandemic, Biogen has continued to execute well on our strategy. I will now turn the call over to Al for a more detailed update on our recent progress in R&D.

In Q1, we generated approximately $1.5 billion in cash flow from operations.

We continue to have the financial flexibility and capacity to evaluate potential X and they'll be says development and M&A opportunities and remain active on the BD front.

As we have demonstrated in the past we are committed to maximizing returns for shareholders, while continuing to bring innovative therapies to patients something that demand is thoughtful approach towards all our investment over both the short and long term.

In summary, despite the challenges due to the copied 19 pandemic Biogen has continued to execute well on our strategy.

I will now turn the call over to on for a more detailed updates on our recent progress in R&D.

Al Standrock: Thank you, Michelle, and good morning, everyone. Before I begin, let me first take a moment to say how proud I am of the way the R&D organization has stepped up in response to the COVID-19 pandemic. I'm inspired by their resilience and their unwavering commitment to our patients. Let me now review the steps we have taken in R&D. In line with recent global regulatory guidance, we have developed a set of principles to guide our clinical trial conduct under these exceptional circumstances. First, the safety of all of our clinical trial participants and their health care providers as well as the integrity of the data we collect will remain paramount. Second, given the importance of our clinical trials to patients with serious diseases, we aim to continue our ongoing trials as long as the risk to patient and healthcare provider safety as well as data integrity can be sufficiently mitigated.

Thank you Michelle and good morning, everyone.

Before I begin let me first take a moment to say how proud I am the way. The R&D organization has stepped up in response to the call that 19 pandemic.

I'm inspired by their resilience in their unwavering commitment to our patients.

Let me now review the steps we have taken within R&D.

In line with recent global regulatory guidance, we have developed a set of principles to guide our clinical trial conduct under these exceptional circumstances.

First the safety of all of our clinical trial participants and their health care providers as well as the integrity of the data we collect will remain paramount.

Second given the importance of our clinical trials to patients with serious diseases. We aim to continue our ongoing trials as long as the risk the patient and health care providers safety as well as data integrity can be sufficiently mitigated.

Third we are generally, allowing new enrollment of new patients site and countries into ongoing clinical trials. However, this may be stopped on a study by study basis, if such enrollment compromises our ability to mitigate risk the patient and health care providers safety and data.

Al Standrock: Third, we are generally allowing the enrollment of new patients, sites, and countries into ongoing clinical trials. However, this may be stopped on a study-by-study basis if such enrollment compromises our ability to mitigate risk to patients and healthcare provider safety and data integrity. Fourth, we may allow for the initiation of new clinical studies on a region-by-region basis, as long as the risk to safety and data integrity can be sufficiently mitigated. However, we are implementing a limited pause on the initiation of new clinical trials evaluating molecules that suppress the immune system or specifically modulate antiviral responses, with a reassessment in the coming months. This includes pausing the initiation of the planned Phase 3 study of the pegylated anti-CD40 ligand FAB in systemic lupus erythematosus in collaboration with UCB.

Really.

Fourth we may allow for the initiation of new clinical studies on a region by region basis as long as the risk to safety data integrity can be sufficiently mitigated.

However, we are implementing a limited pause on the initiation of new clinical trials evaluating molecules, which suppress the immune system or specifically modulator anti viral responses with a reassessment in the coming month.

This includes pausing the initiation of the planned phase three study of the Pegylated anti CD 40 like in fab in systemic lupus erythematosus in collaboration with you CP.

And fifth we are reviewing informed consent forms from all studies to ensure that potential risks associated with traveled to study sites and where applicable product specific risks a viral infection or appropriately highlighted.

Al Standrock: And fifth, we are reviewing informed consent forms from all studies to ensure that potential risks associated with travel to study sites and, where applicable, product-specific risks of viral infection are appropriately highlighted. At the same time, we are continuing to monitor how the current situation may impact our projected timelines for ongoing studies. While the situation remains fluid, we continue to expect the vast majority of the 10 remaining mid to late stage data readouts that we recently highlighted to occur by the end of 2021.

At the same time, you're continuing to monitor how the current situation may impact our projected timeline for ongoing study.

Well the situation remains fluid we continue to expect the vast majority of the 10 remaining mid to late stage data readout they'd be recent we highlighted to occur by the end of 2021.

Al Standrock: However, we do anticipate that a portion of these 10 readouts will be delayed, including the Phase 3 study of BIP-93 or IV glabenquimide for large hemispheric infarction, as this study involves administration of BIP-93 in an acute hospital setting. As we move forward, we will continue to prioritize both patient safety and data integrity, but we are not able to provide further details on the timing of readouts As Michelle mentioned, we are pursuing a number of initiatives to mitigate further impact on our ongoing clinical studies. These include remote monitoring, remote data verification, supporting patient and staff travel to study sites, launching a direct-to-patient delivery service for our investigational therapies, supporting at-home infusions, and providing telemedicine options to minimize the number of missed study visits and study withdrawals. Finally, each study in our portfolio will undergo a COVID-19-specific risk assessment to highlight study-specific risks to operational or scientific aspects, identify appropriate mitigation strategies, and ensure compliance with evolving regulatory guidelines. We recently rolled out remote site monitoring, and we are working to implement the remainder of these initiatives as soon as possible.

However, we do anticipate that a portion of these 10 readouts will be delayed including the phase three study, if they've 93 or Ivy glut banquet, Mike for large hansberry can function. As this study involve administration that bid 93 in an acute hospital setting.

As we move forward, we will continue to prioritize both patient safety and data integrity, but we're not able to provide further details on the timing of read out at this stage.

As Michelle mentioned, we are pursuing a number of initiatives to mitigate further impact to our ongoing clinical study.

These include remote monitoring remote data verification supporting patient and staff traveled to study sites launching that direct to patient delivery service for our investigational therapies supporting at home infusion and providing tele medicine options to minimize the number of Miss study visits.

And study withdrawals.

Finally, each study in our portfolio will undergo a code at 19 specific risk assessment. The highlights study specific risks to operational or scientific aspects.

Hi, Fi appropriate mitigation strategies, and ensure compliance with evolving regulatory guideline.

We recently rolled out remote site monitoring and we're working to implement the remainder of these initiatives as soon as possible.

In parallel with these efforts to mitigate risk to our pipeline. We aim to elucidate helped to elucidate the mechanisms underlying cobot 19 passes Genesis and advanced the development potential therapeutic solutions.

Al Standrock: In parallel with these efforts to mitigate risk to our pipeline, we aim to elucidate, or help to elucidate, the mechanisms underlying COVID-19 pathogenesis and advance the development of potential therapeutic solutions. To this end, this month, we announced that we are launching a consortium that will build and share a COVID-19 biobank working with the Broad Institute of MIT and Harvard and Partners Healthcare, which includes Massachusetts General Hospital and Brigham This biobank aims to centralize and facilitate the study of a large collection of de-identified samples and medical data with the aim of unraveling the biology of COVID-19, linking molecular signatures with clinical presentation, and accelerating the search for potential treatment.

To this and this month, we announced that we're launching a consortium that will build and share at Cobiz 19, Biobank working with the Brode Institute at MIT, and Harvard and partners Health care, which includes Massachusetts General Hospital, and Brigham and Women's Hospital.

This biobank aims to centralize and facilitate study of a large collection of de identified samples and medical data with the aim of Unravelling. The biology of Kogut 19, linking molecular signal signatures with clinical presentation and accelerating the search for potential treatment.

Al Standrock: Many of my Biogen colleagues have been eager to find ways to help during this pandemic, and we are proud to be a founding member of this consortium. The biobank will include samples and medical data from volunteer Biogen employees who have recovered from COVID-19, as well as their close contacts. Last month, we signed a letter of intent and began collaborating with Veer Biotechnology to accelerate process development and manufacturing of human monoclonal antibodies that may neutralize SARS-CoV-2, the virus responsible for COVID-19. We are proud to leverage our extensive expertise and capabilities in advanced biologics manufacturing to collaborate with FEAR and potentially accelerate the development of therapies to combat this epidemic. Finally, given the effect that type 1 interferons show in the antiviral response in vitro, we are engaging with investigators who may be interested in evaluating the potential of our beta interferon products in the treatment of COVID-19. In sum, the R&B organization at Biogen has taken significant steps to respond to the unprecedented challenge posed by COVID-19.

Many of my Biogen colleagues have been eager to find ways to help during this pandemic and we are proud to be a founding member of this consortium.

The bio bank will include samples and medical data from volunteer Biogen employees, who have recovered from quoted 19 as well as they're close contact.

And last month, we signed a letter of intent and began collaborating with beer biotechnology to accelerate process development and manufacturing of human monoclonal antibodies that may neutralize Sars koby to virus responsible for covers 90.

We are proud to leverage our extensive expertise and capabilities in advanced biologics manufacturing to collaborate with fear and potentially accelerate the development of therapies to combat this epidemic.

Finally, given the effect of that type one interferon show in the anti viral response in vitro we are engaging with investigators who maybe interested in evaluating the potential of our beta interferon products in the treatment of club at 90.

In some of the R&D organization at Biogen has taken this significant steps to respond to the unprecedented challenges posed by Cobiz 90.

Al Standrock: We aim to continue advancing our innovative neuroscience pipeline while contributing to the shared understanding of COVID-19 biology and the advancement of potential treatments. Let me now turn to the advances we made across our pipeline in the first quarter, starting with Alzheimer's disease and dementia. As Michelle mentioned, we continue to make progress toward the regulatory filing for adjucanumab in the United States. We have begun to submit BLA modules, and we expect to complete the filing in Q3.

We aim to continue advancing our innovative neuroscience pipeline, while contributing to the shared understanding of quoted 19 biology and the advancement of potential treatment.

Let me now turn to the advances we made across our pipeline in the first quarter, starting with all times disease and dementia.

As Michelle point mentioned, we continue to make progress toward the regulatory filing fragile Canyon, Matt in the United States.

We have begun to submit be allay modules and expect to complete the filing in Q3.

Al Standrock: At the virtual ADPD meeting earlier this month, we held an encore presentation of the aducanumab phase 3 top line results. The data in this presentation were previously presented at the CTAD Annual Congress last December. And last month, we dosed the first patient in the Embark Redosing Study. In this study, eligible patients previously enrolled in our clinical trials, including patients previously treated with either aducanumab or placebo, will be titrated to 10 mg per kg aducanumab infusions every 4 weeks. Beyond Educandumab, we continue to advance a broad Alzheimer's disease portfolio, including the Phase III study of BAN2401. BIV-80, a Tau-targeted antisense oligonucleotide in Phase 1, and BIB-76, an anti-tau antibody in Phase 1, and Gosaranumab, a distinct anti-tau antibody in Phase 2.

At the virtual 80, P.D. meeting earlier this month, we held an encore presentation of the education Mad Phase three topline results.

The data in this presentation were previously presented at the Sicad Annual Congress Congress last December.

And last month, we dosed the first patient in the embark re dosing study.

In this study eligible patients previously enrolled in our clinical trials, including patients previously treated with either add you can you map or placebo will be tied traded <unk> to 10 milligrams per kilogram as you can imagine infusions every four weeks.

Beyond that you can you, Matt we continue to advance a broad all climbers disease portfolio, including the phase three study advancing 401.

Did the 88 targeted antisense oligonucleotides in phase one.

And they bid 76 and anti Tau antibody in phase one and it goes ran about this thing anti Tau antibody in phase two.

Turning to neuromuscular disorders.

Al Standrock: Turning to neuromuscular disorders, last month an independent observational cohort study evaluating the safety and efficacy of Spinraza in 139 teens and adults with SMA was published in Lancet Neurology, representing the largest study of Spinraza in teens and adults to date. In contrast to the natural history of SMA, this real-world study found that treatment with Spinraza was associated with statistically significant increases in total hammersmith force compared to baseline at 6, 10, and 14 months of treatment. Of note, a clinically meaningful improvement, defined as an increase of at least three points in the Hammersmith score, was observed in 40% of patients at the 14-month assessment. No new safety concerns were identified, and no serious adverse events were reported.

Last month, an independent observational cohort study evaluating the safety and efficacy of Spinraza and 139 teens in adults with estimate was published in lancet neurology, representing the largest study of Spinraza in teams in adults today.

In contrast to the natural history of estimate this real World study found that treatments Spinraza was associated with statistically significant increases in total Hammersmith fords compared to baseline at six and 14 months or treatment.

Oh, no a clinically meaningful improvement defined as an increase of at least three points in the Hammersmith score was observed in 40% of patients at the 14 month assessment.

No no safety concerns were identified and no serious adverse events were reported.

Al Standrock: These data, once again, underscore the durable efficacy and well-established longer-term safety profile of Spinraza across a broad range of SMA patients, including adults. Last month, we dosed the first patient in DEVOTE, a Phase 2-3 study evaluating whether higher doses of Spinraza can provide even greater efficacy than the currently approved dose. This study was motivated by SPINRASA's well-characterized safety profile, as well as our PKPD data suggesting that individuals with higher CSF concentrations of SPINRASA achieve greater improvements in CHOP and TEN scores and motor milestones. Also last month, we submitted an IND for BIM-105, an antisense oligonucleotide targeting Ataxin-2 for sporadic ALS. The FDA has since reviewed the IV and deemed it to be safe to proceed. We are particularly excited by this program for the 90% of ALS patients who have sporadic disease.

These data once again underscore the durable efficacy and well established longer term safety profile of spinraza across a broad range of estimate patients including adult.

Last month, we dosed the first patient in devote a phase two three study evaluating whether higher doses of Spinraza can provide even greater efficacy and the currently approved dose.

This study was motivated by Spinraza as well characterized safety profile as well as our PK PD data suggest that individuals with higher CSF concentrations of Spinraza achieved greater improvement in chop in 10 scores and modern mile and motor milestones.

Also last month, we submitted an eye and the forbid one <unk> five and antisense oligonucleotides targeting eightx into four sporadic gala.

The FDA has since reviewed the Ivy and deemed to be safe to proceed.

We are particularly excited by this program for the 90% of validate allows patients who have sporadic disease.

Al Standrock: Trinucleotide repeat expansions in the Atexin-2 gene have been associated not only with an increased risk of developing ALS but also with an increased rate of disease progression in those patients. Importantly, Ataxin-2 was originally identified as a modifier of TDP-43 toxicity, a pathology common to more than 90% of the ALS population, suggesting that reduction of Ataxin-2 could be therapeutic in the sporadic ALS population Moving to our progress in MS and neuroimmunology, for patients with relapsing forms of MS, plegidy remains a convenient treatment option with a well-established safety and efficacy profile. However, tolerability, including injection site reactions, has been the leading cause of discontinuation.

Try nucleotide repeat expansions expansions in the Eightx into gene I've been associated not only with an increased risk of developing or less but also with an increased rate of disease progression in those patients importantly, a texas to was originally identified as a modifier of TDP 43 talk.

Since city, a pathology comment to more than 90% of the a less population, suggesting that reduction or they tags into could be therapeutic in the sporadic aeolus population.

Moving to our progress in M.S. and neuro immunology for patients with relapsed <unk> form to that math legacy remains a convenient treatment option with a well established safety and efficacy profile, however, tolerability, including injection site reaction has been the leading cause of discontinuation.

Al Standrock: At the ACTRIMS meeting held in February, we presented data investigating whether intramuscular administration of PLEGRIDY might reduce injection site reactions compared to subcutaneous dosing while maintaining bioequivalence. On the primary endpoint, there was bioequivalence between the two routes of administration in terms of plasma exposure. We also found that the proportion of patients reporting injection site reactions was reduced by over 50% after intramuscular dosing compared to subcutaneous

At the ACTRIMS meeting held in February we presented data investigating whether intramuscular administration of buggery might reduce injection site reactions compared to subcutaneous dosing, while maintaining bio equivalents.

On the primary endpoint there was bio equivalence between the two routes of administration on plasma exposures.

We also found that the proportion of patients reporting injection site reactions was reduced by over 50% after intramuscular dosing compared to subcutaneous dosing.

Al Standrock: We have submitted regulatory filings for an intramuscular formulation of plaguity in both the United States and the EU. In March, the FDA updated the labels of Avonex and Plegri to include data to assist health care providers when considering use during pregnancy. This follows label updates in Europe last year that removed the contraindication for use during pregnancy. These changes to the label are significant, given that women are diagnosed with MS at least two to three times more frequently than men, and women are often affected during their childbearing years.

We have submitted regulatory filings for an intra muscular formulation of PLEGRIDY in both the United States and the E U.

In March the FDIC updated the labels of Avonex antibody to include data to assist health care providers when considering use during pregnancy.

This follows label updates in Europe last year that removed the country indication for use during pregnancy.

These changes to the label are significant given that women are diagnosed with M.S. at least two to three times more frequently than that.

And women are often affected during their childbearing years.

Al Standrock: We recently received top-line data from OPUS, a randomized Phase II study exploring the efficacy, safety, and tolerability of natalizumab as an adjunctive therapy in patients with drug-resistant focal epilepsy. However, the primary endpoint was not met, and thus, we have decided to discontinue development of natalizumab in drug-resistant focal epilepsy. Last month, data from the Phase 1-2 Dose Escalation Study of BIN1-12, our AAV-based gene therapy targeting X-linked retinitis pigmentosa, or XLRP, were published in Nature Medicine. Overall, results from this study indicated an acceptable safety profile and dose-responsive gains in visual function with 7 of 18 patients experiencing early increases in central retinal sensitivity that were sustained at month 6 of follow-up.

We recently received topline data from Opus, a randomized phase two study exploring the efficacy safety and Tolerability and that'll isn't that as an adjunct therapy in patients with drug resistant focal epilepsy.

However, the primary endpoint was not in that and thus we have decided to discontinue development and that'll isn't map and drug resistance local epilepsy.

Last month data from the phase one two dose escalation study of bid 112 are a the base gene therapy targeting excellent retinitis pigmentosa or XL RP were published in nature Medicine.

Overall results from this study indicated an acceptable safety profile and dose response of gains with gains in visual function with seven of 18 patients experiencing early increases in central retinal sensitivity that were sustained at month six a follow up.

And in business development right, we recently announced abroad collaboration with Sangamo therapeutics to leverage their proprietary think finger protein platform.

Al Standrock: This technology enables the generation of designer DNA binding proteins that can be easily packaged into an AAD vector and serve as specific, potent, and tunable regulators of gene expression. Through this collaboration, we also have access to Sangamo's CAPCID engineering platform, which has the potential to identify novel CAPCIDs to allow more efficient and specific delivery of AAV payloads to the central nervous system. We will first focus on programs for Alzheimer's disease, Parkinson's disease, and a third neuromuscular disease target with exclusive access to up to nine additional neurological targets. Overall, we remain undeterred in our mission to develop novel therapies for devastating neurological diseases, and I am proud of our team's agility in responding to this pandemic. I am optimistic that we will work through these challenges, mitigate potential impacts to our program, and continue to progress our pipeline. I will now pass the call to Geoff.

This technology enables the generation of designer DNA binding proteins that can be easily package into an A.B. vector and serve as specific pout potent and tunable regulators of gene expression.

Through this collaboration we have all we also have access to Sangamo capsid engineering platform, which has the potential to potentially which has the potential to identify novel capsid to allow more efficient and specific delivery of baby payload to the central nervous system.

We will first focus on programs for all Simon's disease, Parkinson's disease, and the third neuromuscular disease target with exclusive access to up to nine additional neurological targets.

Overall, we remain undeterred and on mission to develop novel therapies for devastating neurological diseases and I am proud of our teams agility in responding to this pandemic.

I am optimistic that we will work through these challenges mitigate potential impacts to our program and continue to progress our pipeline.

Ill now pass the call to Jeff.

Jeff Capello: Thanks, Al. Good morning, everyone. Prior to starting my comments on the financial performance, I want to highlight that we believe the fundamentals of our business are strong, and we are well positioned. Our products are important therapies for patients living with serious diseases. We have strong operating processes, enabling us to operate effectively through these challenging times. We also pride ourselves on our ability to execute well commercially. In addition, we are well-capitalized financially. These are, however, unprecedented times that will have an impact on our business.

Thanks, Bill good morning, everyone.

Prior to starting my comments in the financial performance I want to highlight that we believe the fundamentals of our business were strong and we're well positioned.

Our products are important therapies for patients living with serious diseases.

We have strong operating process, enabling us to operate effectively through these challenging times.

We also pride ourselves and our ability to execute well commercially.

In addition, we're well capitalized financially.

These are however, unprecedented times, so that will have an impact on our business.

Jeff Capello: I will now review our financial performance, highlighting the various factors to give you a sense of our performance, and then wrap up with commentary on our outlook. I'll start with our revenue. Total revenues for the first quarter grew 1% year-over-year to approximately $3.5 billion. It's important to note that we believe Q1 benefited from approximately $100 million attributed to accelerated sales due to the COVID-19 pandemic, primarily in Europe. As a reminder, Q1 2019 included a benefit of approximately $200 million in other revenues due to the sale of hemophilia inventory to BioVeritas. Overall, we executed well in our MS business, delivering revenues of approximately $2.3 billion in the first quarter of this year, including Ocrevus royalties of approximately $162 million, growing 9% versus the prior year.

I will now review our financial performance highlighting the various factors to give you a sensor performance and then wrap up with commentary on our outlook I'll start with our revenues.

Total revenues for the first quarter grew 1% year over year to approximately 3.5 billion.

It's important to note that we believe Q1 benefited.

From approximately a $100 million attributed to accelerated sales due to cold at 19 pandemic primarily in Europe.

As a reminder, Q1 2019 included the benefit for approximately 200 million in other revenues due to the sale of hemophilia inventory to buy there.

Overall, we executed well in or in this business delivering revenues of approximately 2.3 billion in the first quarter this year, including brokers royalties of approximately 162 million growing 9% versus prior year.

Jeff Capello: Global MS revenues in Q1 2020 increased 7% versus the prior year without Ocrevus roles. USMS revenues, excluding Ocrevus, increased 4% or $58 million versus the prior year. U.S. MS revenues in Q1 2020 were impacted by a decrease in channel inventory of approximately $115 million, compared to a decrease of approximately $170 million in Q1 2019. We estimate that we had $54 million in additional sales due to a greater number of shipping days in the quarter, roughly half of which impacted the inventory quarterly change.

Mobile Fms revenues in Q1, 2020 increased 7% versus the prior year Workovers royalties.

You SMS revenues, excluding okra, this increased 4% or 58 million versus the prior year.

You SMS revenues in Q1, 2020 were impacted by decreasing channel inventory of approximately 15 million compared to a decrease of approximately 170 million in Q1 29 team.

We estimate that we had 54 million an additional sales due to a greater number shipping days in the quarter roughly half of which impacted the inventory quarterly change.

Jeff Capello: In addition, we believe we benefited from a net $15 million sales impact due to COVID-19, primarily impacting TechVidera. Outside the US, RMS revenues grew 11% or $77 million on higher volumes with minimal price impact and an estimated COVID-19 beneficial impact of $59 million, primarily split between Techvidare and Interferon.

In addition, we believe we benefited from a net $15 million sales impact due to cobot 19, primarily impacting tech for there.

Outside the U.S., our Emmis revenues grew 11% were 77 million on higher volumes with minimal price impact and an estimated called the 19 beneficial impact of 59 million primarily split between tech for their and interferon.

Global first quarter for unit revenues, including tech for their and humidity increased 10% versus the prior year driven by revenue growth both in the U.S. and outside the U.S.

Jeff Capello: Global first quarter FUMIT revenues, including TechFedera and Bloomerity, increased 10% versus the prior year, driven by revenue growth both in the U.S. and outside the U.S. In the U.S., fumarate revenue grew 8%, or $16 million, versus the prior year. U.S. fumarate revenues were impacted by a decrease in channel inventory of approximately $85 million in the first quarter of 2020 compared to a decrease of approximately $110 million in Q1 2019. Compared to the prior year, we saw favorable demand for Tecvidera, which we believe is primarily due to the extra shipping days and COVID-19 impact, with roughly stable underlying performance without those impacts. After an initial channel load in Q4, Bumerity had sales of $2 million in the U.S. in the first quarter of 2020, and we were making good progress securing access and reimbursement.

In the U.S. funeral revenue grew 8% or 60 million versus the prior year.

You as fuel <unk> revenues were impacted by decreasing channel inventory of approximately 85 million in the first quarter of 2020 compared to a decrease of approximately 110 million in Q1 2019.

Versus the prior year, we saw favorable demand for tech reader, which we believe is primarily due to the extra shipping days and cobot 19 impact with roughly stable underlying performance without those impacts.

After an initial channel load in Q4, we already had sales of 2 million in the U.S. in the first quarter of 2020, and we're making good progress securing access and reimbursement.

Jeff Capello: Within the U.S., we were pleased to see strong execution with continued stability in our share of total prescriptions for the fumarates versus the prior quarter in light of increased competition. It's important to note that the vast majority of Tecvidera and Boomerang prescriptions in the U.S. are delivered via mail order, and as a result, we do not expect a significant impact on Tecvidera due to COVID-19. Outside the U.S., Techvidere again performed very well.

Within the U.S., we were pleased to see strong execution was continued stability in our share of total prescriptions performance versus prior quarter in light of increased competition.

It's important to note that the vast majority of tech were there and Gramercy prescriptions in the U.S. are delivered via mail order and as a result, we do not expect a significant impact to secretary due to cope with 19.

[noise] outside the U.S. Secretary again performed very well.

Jeff Capello: With Q1 2020 revenues growing 15% or $42 million, including an estimated benefit of approximately $28 million due to inventory dynamics related to COVID-19. Additionally, the number of tachypter patients outside the U.S. grew by approximately 13% versus the prior year, driven by positive patient growth in the large European markets and approximately 40% patient growth in Latin America and Asia-Pacific combined. In total, we were pleased to see strong global patient growth for Tecmodera of approximately 8% year-over-year. However, Q1 Global Interfering Revenues, including both ABNICS and Plagarity, decreased 7% versus Q1 2019. The shift from injectable platforms to oral or high-efficacy therapy.

Q1, 2020 revenues growing 15% were 42 million, including an estimated benefit of approximately 28 million due to inventory dynamics related code at 19.

Importantly, the number tech for their patients outside the U.S. grew by approximately 13% versus the prior year driven by parts of patient growth in the large European markets and approximately 40% patient growth in Latin America Asia Pacific combined.

In total we were pleased to see strong global patient growth protect medaire of approximately 8% year over year.

Q1 global interfere in revenues, including book Ethics integrity decreased 7% versus Q1 2019.

Good shift from injectable platforms to oral or high efficacy therapies.

In the U.S. interferon revenues decreased 11% were 35 million versus the prior year.

Jeff Capello: In the U.S., Interferon revenues decreased 11%, or $35 million versus the prior year. In the U.S., Avonex and Plygridig were impacted by the continued transition to oral and high efficacy therapies and by a decrease in channel inventory of approximately $35 million, compared to a decrease of approximately $15 million in Q1 2019, partially impacted by extra shipping costs. Similar to Tecfider, the vast majority of interferon prescriptions in the U.S. are delivered via mail order.

Within the U.S. Amex and PLEGRIDY impacted by the continued transition to rural and high ethically therapies and by a decrease in channel inventory of approximately 35 million compared to a decrease of approximately 50 million in Q1 2019, partially impacted by the extra shipping days.

Similar to tech for there the vast majority of Intercurrent prescriptions in the U.S. are delivered via E Mail order.

Jeff Capello: Outside the U.S., interfering revenues were stable versus the prior year, with an estimated benefit of approximately $21 million due to increased channel inventory related to COVID-19. Given their safety profile and potential antiviral properties, we are seeing an increased interest in our interferon products, which may present an opportunity for less erosion in this franchise going forward. This is a dynamic that we'll watch carefully as time progresses.

Outside the U.S. interfere in revenues were stable versus the prior year with an estimated benefit of approximately 21 million due to increased channel inventory of late at the corporate 19.

Given their safety profile and potential antiviral properties, we're seeing an increased interest in our interferon products, which may present, an opportunity for less erosion. In this franchise going forward. This is a dynamic the watch carefully as time progresses.

To Sabri worldwide revenues increased 13% were 62 million versus the prior versus the first quarter of 2019.

In the U.S. to 70 revenues increased 13% versus the prior year or 33 million.

You asked the Sabri revenues were impacted by increasing channel inventory of approximately 5 million compared to a decrease of approximately 10 million in Q1 2019.

Jeff Capello: DeSavvy Worldwide revenues increased 13%, or $62 million versus the first quarter of 2019. In the U.S., sovereignty revenues increased 13% versus the prior year, or $33 million. U.S. to Saudi revenues were impacted by an increase in channel inventory of approximately $5 million, compared to a decrease of approximately $10 million in Q1 2019. In the U.S., we were pleased to see roughly stable adjusted volume and share of new prescriptions, as well as an increased share of total prescriptions for Sabri versus the prior quarter. Outside the U.S., disability revenues increased 14% or $29 million versus the prior year with an estimated benefit of approximately $7 million due to increased channel inventory related to COVID-19. Q1 2020 TSABI revenues benefited by approximately $20 million due to price adjustments in Italy related to prior periods.

Within the U.S., we were pleased to see roughly stable adjusted volumes.

And share of new prescriptions as well as an increase your total prescriptions for Sabrina versus the prior quarter.

Outside the U.S. discovery revenues increased 14% for 29 million versus the prior year was with an estimated benefit of approximately 7 million due to increased channel inventory related to cope with 19.

Q1, 2020 to savvy revenues benefited by approximately 20 million due to price adjustment in Italy related to prior periods outside the U.S.. We were pleased to see continued patient growth of 4% purchase RB versus the prior year.

Given that the salary is administered in the physician's office or hospital setting, we do expect an impact from cobot nineteena to sovereign sales.

As we attempt to mitigate this risk we're working to enable to Sabri home infusions within the U.S. where appropriate.

[laughter].

Overall, we were pleased with the execution or the ever Emmis franchise and the continued strong performance upper Emus business was the first quarter. While there were some uncertainty in around this trajectory given cobot 19, particularly for Sarvary, they're also opportunities and we remain encouraged by the resilience of our market leading franchise.

Let me now move on to Spinraza [laughter] excuse me [noise].

[noise] global first quarter, Spinraza revenues increased 9% versus the prior year to 565 million in.

Jeff Capello: Outside the U.S., we are pleased to see continued patient growth of 4% for Tysabri versus the prior year. Given that Tysabri is administered in a physician's office or hospital setting, we do expect an impact from COVID-19 on sales of Tysabri. As we attempt to mitigate this risk, we are working to enable Tysabri home infusions within the U.S. where appropriate. Overall, we were pleased with the execution of our MS franchise and the continued strong performance of our MS business in the first quarter. While there is some uncertainty in our MS trajectory given COVID-19, particularly for Sabri, there are also opportunities, and we remain encouraged by the resilience of our market-leading franchise. Let me now move on to Spinraza.

In the U.S. revenues increased 5% versus Q1, 2019 and decreased 3% versus Q4 2019.

The number of patients on therapy in U.S. increased 1% as compared to the into the fourth quarter of 2019, driven primarily by growth in the number of adults.

We believe U.S. spinraza revenues benefited by approximately 6 million due to covert 19.

In addition, leading indicators suggest that we may be seeing a decrease in new patient starts, particularly among adults as well as a decrease in compliance both related to Cook at 19.

We are aware that some physicians and hospitals are delaying spinraza doses as they make difficult prioritization decisions, while confronting cobot 19, although we continue to work to ensure patients received this critical treatment and I've seen more centers come back online.

Yeah.

Outside the U.S. Spinraza revenues increased 12% versus Q1, 2019, and 10% versus Q4, 2013, driven primarily by increased penetration across all major geographies with an estimated benefit of approximately 5 million due to increased channel inventory related to corporate 19.

Jeff Capello: Excuse me. Global first quarter Spinraza revenues increased 9% versus the prior year to $565 million. In the U.S., revenues increased 5% versus Q1 2019 and decreased 3% versus Q4 2019. The number of patients on therapy in the U.S. increased 1% as compared to the end of the fourth quarter of 2019, driven primarily by growth in the number of adults. We believe U.S. Spinraza revenues benefitted by approximately $6 million due to COVID-19. In addition, leading indicators suggest that we may be seeing a decrease in new patient starts, particularly among adults, as well as a decrease in compliance, both related to COVID-19. We are aware that some physicians and hospitals are delaying Spironazid doses as they make difficult prioritization decisions while confronting COVID-19, although we continue to work to ensure patients receive this critical treatment and have seen more centers come back online.

Outside the U.S., we have also seen a moderate impact on demand for Spinraza due to cope at 19, which we expect may continue.

As a reminder, the first quarter of last year benefited from a positive pricing adjustment of 14 million in France negatively impacting the year over year comparison.

In total outside the U.S. the number of commercial spinraza patients increased approximately 10% versus prior quarter.

Broad growth occurred again across all major regions with an increased number of countries contributing as we continue this very successful product launch.

Overall, we were pleased with Spinraza is performance in the first quarter.

I'll be recognized through some uncertainty in its trajectory given cobot 19 pandemic, we still believe their continued opportunities for growth given the significant number of untreated patients, including in many established and emerging markets.

Jeff Capello: Outside the U.S., Panarasa revenues increased 12% versus Q1 2019 and 10% versus Q4 2019. Unknown Executive, Ami Fadia, Adam Keeney, and Chris Schott, Biogen Inc., with an estimated benefit of approximately $5 million due to increased channel inventory related to COVID-19. Outside the U.S., we have also seen a moderate impact on demand for Spinraza due to COVID-19, which we expect may continue. As a reminder, the first quarter of last year benefited from a positive pricing adjustment of 14 million euros in France, negatively impacting the year-over-year comparison. In total, outside the U.S., the number of commercial Spinaraza patients increased approximately 10% versus the prior quarter. Broad growth occurred again across all major regions, with an increased number of countries contributing as we continue this very successful product launch. Overall, we were pleased with Spinaraz's performance in the first quarter.

Let me now move onto a bio similars business, which generate 209 10 million in this quarter growing 25% versus the prior year over 44 million.

We estimate that there were now approximately 215000 patients using your bio similars in Europe.

Then the poly remains the number one prescribed enbrel biosimilar across the major you five markets.

Like Sabi volume grew 90% versus the prior year in a multi volumes grew 28% versus fourth quarter.

Despite our biosimilar business benefiting by approximately 15 million due to covert 19, when the quarter. This business again performed well and has the opportunity to continue to grow both in Europe, as well as potentially because in U.S. and other geographies with our additional assets.

Total anti Cdtwenty revenues in Q1 increased 1% versus the prior year.

With increased opus royalties offsetting decrease revenues from a toxin due to recent introduction Nobel summers.

Total other revenues in the first quarter decreased 63% versus prior year due primarily to the prior period sale of approximately 200 million hemophilia inventory to buy a veritiv in the first quarter of 2019.

Let me know turned to gross margins.

Q1, 2020, gross margin was 87% improvement versus 83% in the prior year due to lower contract manufacturing revenue and was relatively stable versus the prior quarter.

Jeff Capello: While we recognize there is some uncertainty in its trajectory given the COVID-19 pandemic, we still believe there are continued opportunities for growth given the significant number of untreated patients, including in many established and emerging markets. Let me now move on to our biosimilars business, which generated $219 million this quarter, growing 25% versus the prior year, or $44 million. We estimate that there are now approximately 215,000 patients using our biosimilars in Europe. Venipalli remains the number one prescribed embryo biostimulant across the major EU5 markets.

Q1, GAAP and non-GAAP R&D expense for both 13% of revenue as a reminder, R&D expense in the first quarter 2019 included approximately 39 million weighted or agreement was skyhawk inappropriate approximately 45 million a net close it cost for the phase three studies of a do kitimat.

R&D expense in Q1, 2020 was lower in part due the timing of milestones which are difficult to predict.

No in the second quarter of 2020, we expect recorded GAAP and non-GAAP or do you expense of 125 million for license fee related to our collaboration was saying about.

Q1, GAAP and non-GAAP best you name or both 16% of revenue, we still expect SG need to increase throughout the year as we ramp up our commercial preparations read you kill them out.

Jeff Capello: Aksabi volume grew 90% versus the prior year, and Emeraldi volumes grew 28% versus the fourth quarter. Despite our biosimilar business benefiting by approximately $15 million due to COVID-19 within the quarter, this business again performed well and has the opportunity to continue to grow both in Europe as well as potentially within the U.S. and other geographies with our additional assets. Total NCCD 20 revenues in Q1 increased 1% versus the prior year, with increased Ocrevus royalties offsetting decreased revenues from Rituxan due to the recent introduction of Valzthelm. Total other revenues in the first quarter decreased 63% versus the prior year, due primarily to the prior period sale of approximately $200 million of hemophilia inventory to Via Verita in the first quarter of 2019. Let me now turn to Gross Margin. Q1 2020 Gross Margin was 87%, an improvement versus 83% in the prior year due to lower contract manufacturing revenue and relatively stable versus the prior quarter.

Q1, GAAP other expense was 120 million, which included 61 million in unrealized losses investments, primarily driven by decreasing the fair value ever actually equity investment in islands.

Q1, non-GAAP other expense was 60 million.

In Q1 of this year, our GAAP and non-GAAP tax rates were both approximately 17%.

In the first quarter 2019, or GAAP effective tax rate included a one time charge related to the plan divestiture of our Hillary Denmark manufacturing operations as well as higher unrealized gains.

We repurchased approximately 7.3 million shares in the first quarter at an average price of $303 for total value of approximately 2.2 billion.

The share repurchase program authorized in March 2019 has now been completed and as of the ended the first quarter. Approximately 4.1 billion was remaining under the share repurchase program authorized in December.

No brings us toward diluted earnings per share in the first quarter, we booked GAAP EPS of 8008 cents, an increase of 13% versus the prior year and non-GAAP earnings of 9014 cents per share a 31% increase versus the prior year.

We generated approximately one and a half going to net cash flows from operations in Q1.

Jeff Capello: Q1 GAAP and non-GAAP R&D expense were both 13% of revenue. As a reminder, R&D expense in the first quarter of 2019 included approximately $39 million related to our agreement with Skyhawk and approximately $45 million in net close-out costs for the Phase III studies of a due candidate. R&D expense in Q1 2020 was lower in part due to the timing of milestones, which are difficult to predict. Note, in the second quarter of 2020, we expect to record a GAAP and non-GAAP R&D expense of $125 million for the license fee related to our collaboration with Fang. G1 GAAP and non-GAAP SG&A were both 16% of revenue. We still expect SG&A to increase throughout the year as we ramp up our commercial preparations for education.

We ended the quarter with approximately 4.8 billion in cash marketable securities and 6 billion in debt.

As we think it but the balance of the year. We've noticed that these are unprecedented times in their significant uncertainty.

Let me know outline what we do know.

We again performed well operationally in the first quarter.

And saw some benefit from accelerated sales that occurred relative to cope with 19.

We expect some volatility in revenues between the quarters.

We have seen some disruptions start to materialize, particularly for to submarine Spinraza due to physician administration and facility capacity as we have seen some delays in dosing.

We believe our therapies are essential for patients and we're actively working to help patients maintain the dosing schedules.

We're also mindful of the potential macro risks from the economic environment and the impact on the health care systems, including the potential impact on pair mix.

At the same time as demonstrated in the past remained focused on strong commercial execution, which we believe me in part to help mitigate these risks.

We also be benefit from a potential decreasing competitive pressures across several business Aries and potentially renewed interest in their interference therapies.

Jeff Capello: Q1 GAAP other expense was $120 million, which included $61 million in unrealized losses on investment. Primarily driven by a decrease in the fair value of our equity investment, and I own it. Q1 non-GAAP other expense was $60 million. In Q1 of this year, our GAAP and non-GAAP tax rates were both approximately 17%.

As a reminder, weve a policy update our guidance once of your and in July and we should hopefully no more by then.

Let me now turn the call back over to Michel for his closing comments. Thank you Jeff.

I am incredibly proud of how by the Biogen team has responded to the current situation I'm pleased on <unk>. The world have demonstrated the resilience and did you acacia and to advancing elimination.

Well as that compassion and empathy in wanting to be part of this would be shown to these terrible disease.

Jeff Capello: In the first quarter of 2019, our GAAP effective tax rate included a one-time charge related to the planned divestiture of our Hillerod, Denmark manufacturing operations, as well as higher unrealized gains. We repurchased approximately 7.3 million shares in the first quarter at an average price of $303 for a total value of approximately $2.2 billion. The share repurchase program authorized in March 2019 has now been completed.

I would business has remained strong we didn't even sudeten intended results into first quarter and we have demonstrated a GDT in adapting many aspects of whole operations, including the conduct of most of hoping you can trials why do we do anticipate some risks to a business has the results of the pandemic, we believe our opportunities for value creation.

And remains compelling given the significant unmet medical need into disease, we are pursuing.

We just strong coal business and Miss estimate and Biosimilars. We believe we have the foundation to continue building immunity franchise portfolio.

Jeff Capello: And as of the end of the first quarter, approximately $4.1 billion was remaining under the share repurchase program authorized in December. So that now brings us to diluted earnings per share. In the first quarter, we booked GAAP EPS of $8.08, an increase of 13% versus the prior year, and non-GAAP earnings of $9.14 per share, a 31% increase versus the prior year. We generated approximately $1.5 billion in net cash flows from operations in Q1. We ended the quarter with approximately $4.8 billion in cash and marketable securities and $6 billion in debt.

You need the vast majority of our 10 data Readouts remains on track to complete before the end of Twentytwenty one.

Importantly, we have made good progress on the educating about filing and we are actively preparing for potential commission on as we're getting ready to lead the fight in Alzheimer's disease.

Finally, I want to hate to rate our commitment to maximizing returns to shareholders and bringing you know that TCEP piece to patients over the long term. These demands that we continue to look at capital efficiently effectively and appropriately as we have demonstrated in the past we will always strive to have an opt chemotherapy type structure as well as aim.

Jeff Capello: As we think about the balance of the year, we know that these are unprecedented times and there's significant uncertainty. Let me now outline what we do know. We again performed well operationally in the first quarter and saw some benefit from accelerated sales that occurred relative to COVID-19. We expect some volatility in revenues between the quarters. We have seen some disruptions start to materialize, particularly for Disabri and Spinraza, due to physician administration and facility capacity, as we have seen some delays in dosing. We believe our therapies are essential for patients, and we are actively working to help patients maintain their dosing schedule. We are also mindful of the potential macro risks from the economic environment and the impact on the health care systems, including the potential impact on payers. At the same time, as demonstrated in the past, we remain focused on strong commercial execution, which we believe may in part help mitigate these risks. We also may benefit from a potential decrease in competitive pressures across several business areas and potentially renewed interest in our interference therapy. As a reminder, we have a policy to update our guidance once a year and in July, and we should hopefully know more by then. I now turn the call back over to Michel for his closing comments.

Plus you've got your returns from the investments we make.

Our response to these currency tuition exemplifies our broader purpose as an organization as we and our unique science for the betterment of humanity. This includes doing the right thing for patients I'm pleased the environment and the community all of which we believe contribute to long term sustainable shareholder value.

I am proud of what Biogen stands for and I believe this approach positions us well to be a sustainable organization over the long run as we remained focus on being the DJ neuroscientists addressed the tremendous societal needs into space.

Now more than ever I would like to thank our employees around the world. What did you take it to making just getting back on patients life and all of the Heska walkers well on the frontline to bashing because he'd 19 I have been Truteam press housing.

How many ti has to debt into stations 17 times, we that we will open the call for questions.

I.

I'd like to ask your question. Please press Star then one on your telephone keypad as a reminder, again please limit yourself to one question. If you require any further follow up you May press star one again to rejoin the queue and our first question comes from the line of Marc Goodman from SPD Leerink. Your line is open.

Yes, good morning on the I do filing it just seems like there's been a change in the language a little bit with regard to.

The filing.

I guess, everybody was kind of assuming that you had filed or without the file and now it just seems like there was a delay can you give us a little more color on what's going on behind the scenes is it is it covert related is it.

Michelle Venazos: I am incredibly proud of how the Biogen team has responded to the current situation. Our employees all around the world have demonstrated their resilience and dedication to advancing our mission, as well as their compassion and empathy in wanting to be part of the solution to this terrible disease.

Change in the language.

But what you're hearing from Sta.

And then just secondarily can you just give us a little more color on what you were talking about with interactions in Europe, and Japan as well. Thank you.

Michelle Venazos: Our business has remained strong. We delivered solid financial results in the first quarter, and we have demonstrated agility in adapting many aspects of our operations, including the conduct of most of our clinical trials. While we do anticipate some risks to our business as a result of the pandemic, we believe our opportunities for value creation remain compelling given the significant and mathematical need in the diseases we are pursuing. With a strong core business, MS, SMA, and biosimilars, we believe we have the foundation to continue building a multi-franchise portfolio. We believe the vast majority of our 10 data readouts remains on track to complete before the end of 2021.

So thank you for the question that he is the focus of the attention of everyone and the priority we can be organization.

And again.

Again.

We are on track and were receiving inputs from the E and we are engaging very well.

I would say that two main reasons why is it sticking a bit more time and at the company we are.

Right sizing the quality of the submission the shoes the timing we don't want to.

A rush and then face challenges so the qualities important and we have to keep in mind that there is an unprecedented dataset plus could meet okay.

The data about as good a base look was in November and he's very complex with more than 3002.

Michelle Venazos: Importantly, we have made good progress on the aducanumab filing, and we are actively preparing for potential commercial launch as we are getting ready to lead the fight against Alzheimer's. Finally, I want to reiterate our commitment to maximizing returns to our shareholders and bringing innovative therapies to patients over the long term. This demands that we continue to allocate capital efficiently, effectively, and appropriately. As we have demonstrated in the past, we will always strive to have an optimal capital structure as well as aim for superior returns from the investments we make.

The 3200 patients.

Multiple biomarkers and multiple end points and eat you couple that we should be a one it makes a complex and unprecedented dataset.

So I just want to put that upfront before.

<unk>.

Hi, yes so.

Can you hear me.

So I just want to have say that its look timing is is not easy to predict.

We were trying to do that since the initial announcement in October.

And this is an unusual process.

But I I want to emphasize that we now have an.

Okay, and B.L.A., we've started to submit module.

Michelle Venazos: Our response to this current situation exemplifies our broader purpose as an organization as we aim to pioneer science for the betterment of humanity. This includes doing the right thing for patients, employees, the environment, and the community, all of which we believe contribute to the long-term sustainability of this value. I am proud of what Biogen stands for, and I believe this approach positions us well to be a sustainable organization over the long run as we remain focused on being the leader in neuroscience to address the tremendous societal needs in this space. Now more than ever, I would like to thank our employees around the world who are dedicated to making a positive impact on patients' lives and all of the healthcare workers who are on the front lines battling COVID-19. I have been truly impressed with how the entire healthcare community has stood up in the face of these challenging times. With that, we will open the call to questions.

Oh, we have continued constructive engagement with F.D.A. and and we believe we're on track in terms of the potential for approval or there's a I wouldn't read too much else a into this and in terms of your second part of your question, which I believe was Japan and.

Europe, we have started engagement.

Still kind of early relative to the process with the FDA, but we have started.

Our next question comes from the line the parents wins from Goldman Sachs. Your line is open.

Hi, Thanks for taking the.

Russian maybe just a follow up there was just wondering if you can tell us if the F.D. is asked for any additional analyses of the out of Canada map data and then Michelle and now would just be curious your if your level of confidence in the dataset is the same now as when it was.

When you announced your intention to file for approval last year. Thank you.

So yeah. It never have confidence remains the same added we think the rest of the question.

Yes.

ER I would say that we are constantly doing analyses, but nothing really.

Operator: Thank you. I would like to ask a question. Press star then 1 on your telephone keypad.

He has changed in terms of nothing has come up in the data that changes our interpretation of the data.

Operator: As a reminder, again, please limit yourself to one question. If you require any further follow-up, you may press star 1 again to rejoin the queue. And our first question comes from the line of Marc Goodman from SBB Lyrics. Your line is open.

Our view of the fundamentals hasn't changed.

And and I emphasize that are we remain a constructively engage these additional type C meetings are really to further.

Marc Harold Goodman: Yes, good morning. On the ADU filing, it just seems like there's been a change in the language a little bit with regard to the filing. I guess everybody was kind of assuming that you had filed or were about to file, and now it just seems like there was a delay. Can you give us a little more color on what's going on behind the scenes? Is it COVID related? Is it a change in the language of what you're hearing from FDA? And then, just secondarily, can you just give us a little more color on what you were talking about with the interactions in Europe and Japan as well? Thank you.

We're engaged with that the yet as we have been since the very beginning or actually starting last June when we had our first type C meeting.

And our next question comes from the line of Omar Refracs from Evercore ISI. Your line is open.

Hi, Thanks, so much for me taking my question.

Michelle a quick one for you in one for out Michelle you keep mentioning the word good progress on describing how you came out even though it seems like you're now probably need to creep daily meetings, which didn't sound like was the case Craig. So can you elaborate on that.

Michelle Venazos: So thank you for the question that is the focus of everyone's attention and a priority within the organization. Again, we are on track, and we are receiving input from the FDA, and we are engaging very well. I would say there are two main reasons why it's taking a little bit more time, and at the company we are prioritizing the quality of the submission versus the timing. We don't want to rush and then face challenges.

And how it seems like I'm just reading the tea leaves on what you just said and it seems like you're having to run additional analyses that goes might be the reason why additional meetings are happening with FDA and I guess my question is has left you had previously shared feedback with you on the way you guys did amputations for non Completers, because you might recall.

The reason emerge hit on the high dose was because the effect size and Completers was assumed to be the same as non completers and also the whole questioning whether asking it would want you to pull the data has to be shared feedback we're not asking what the feedback has been has Sps chicken feed back with you on that.

Michelle Venazos: So the quality is important, and we have to keep in mind that there is an unprecedented data set. Plus COVID. The database log was in November and is very complex with more than 3,200 patients, multiple biomarkers, and multiple endpoints. And if you couple that with 301, it makes a complex and unprecedented data set. So I just want to put that up front before I build. Al.

So Omer last time, we had the opportunity to.

Dialogue, we didn't have an open BLE.

We didn't have the side.

To the is the to the FDA. So Davies good progress we had additional type C meetings and you have to read here hi interest from the FDA. So this is what we continue to.

Defy as being positive progress.

Michelle Venazos: Timing is not easy to predict. We have been trying to do that since the initial announcement in October, and this is an unusual process. But I want to emphasize that we now have an open BLA, and we've started to submit modules. We have continued constructive engagement with FDA, and we believe we're on track in terms of the potential for approval. I wouldn't read too much else into this. And in terms of the second part of your question, which I believe was Japan and Europe, we have started engagement. It's still kind of early relative to the process with FDA, but we have started.

And.

Mark I went to say that we had always planned to have a pretty BLE meeting where that yeah that hasn't changed that was always in the planning [noise].

And look some members of the team did get cobot and I can tell you it's hard to work when you have cobot.

T mental and physical fatigue or it was such that there were some people who were affected by the disease. So so so I think that that's part of it but I would say that most of it is that I would say the main points is that nothing has come up with the data that has changed.

Our interpretation.

We believe emerge as a positive study it was positive on the pre specified primary and all three secondary endpoints.

Al Standrock: Our next question comes from the line of Terence Flynn from Goldman Sachs. Your line is open.

I mean, we have done in the analyses on engaged to try to figure out why that result was different but we believe that the.

Terence Flynn: Hi. Thanks for taking the question. Maybe just a follow-up question there. I was just wondering if the FDA has asked for any additional analyses of the Atacanamab data, and then Michelle and Al would just be curious if your level of confidence in the data set is the same now as when it was when you announced your intention to file for approval last year. Thank you.

Those are the same and that the potential for approval.

Remains the same as Michelle said from the very beginning.

And if something something would that change we communicate so.

Our next question comes from the line of Ronny Gal from Burns.

Seen your line is open.

Hi, I. Unfortunately, we probably have to you're taking that taking the question will stay with the I did does not seem I guess a question as a twofold first one have have there been you question all right, but the data I mean, we all familiar with some of that issues you placed before not get dressed up but does.

Michelle Venazos: So my level of confidence remains the same. I'll retake the rest of the question.

Al Standrock: Yeah, I would say that we are constantly doing analyses, but nothing really has changed in terms of, nothing has come up in the data that changes our interpretation of the data. Our view of the fundamentals hasn't changed, and I emphasize that we remain constructively engaged. These additional Type C meetings are really to further engage with FDA, as we have been since the very beginning, actually starting last June when we had our first Type C meeting.

Secondly, as you kind of look on death and as the ethanol has an open BNS might have access to the data has had been you questions that have not been raised before raised by that and second should we expect you to present any more data from identified.

During this year and any new analysis that you expect to present before.

We actually get is to see that was the debt you ever deal.

Umer Raffat: And our next question comes from the line of Omar Raffat from Evercore ISI. Your line is open. Hi. Thanks so much for taking my question. Michelle, a quick one for you and one for Al.

Ronnie this is out there.

There were really no new questions. They you know as I said earlier the the the data you know we haven't come up with nothing that really changes our interpretation of the data.

Michelle Venazos: Michelle, you keep mentioning the word good progress when describing EducandyMap, even though it seems like you now probably need a pre-BLA meeting, which didn't sound like it was the case previously. So can you elaborate on that? And Al, it seems like – I'm just reading the tea leaves on what you just said, and it seems like you're having to run additional analyses, and that might be the reason why additional meetings are happening with FDA. And I guess my question is, has FDA previously shared feedback with you on the way you guys did imputations for non-completers? Because you might recall the reason eMERGE hit on the high dose was because the effect size on completers was assumed to be the same as non-completers. And also the whole question of whether FDA would want you to pool the data. Has FDA shared feedback? We're not asking what the feedback is, but has FDA shared feedback with you on that?

And so I would say that fundamental either no big changes.

And no new questions and I would also say that or we're not planning on presenting anything more publicly or at this time, a until hopefully unsold approval.

But that's our plan.

Our next question comes from the line fill in the both from Cowen and company. Your line is open.

Good morning, Thanks for taking my question again sticking with the had academies theme I guess, a two part question.

It is.

Just going back into what has changed in the Q4 call. It sounded like you had said at that time, all that need to happen with some submission of of documents.

There's no mention of additional Pepsi meetings or preapproved feely meeting so.

I guess, where we own mistaken that you still need to have those meetings and.

And that was always part of the plan or did something come up again kind of asking the same question.

Michelle Venazos: So Umer, last time we had the opportunity to dialogue, we didn't have an open BLA, we didn't have a trial mode with the FDA. So there is good progress. We had additional type C meetings, and you have to read here the high level of interest from the FDA. So this is what we continue to qualify as positive progress.

The prompted the need for those meetings and then second I think we're all trying to debate here is the FTC interest in Connecticut, Mab I know you said that there's a high level of interest, but could you maybe give us some better sense of if the FDA is [noise].

Al Standrock: Umer, I would just say that we had always planned to have a pre-BLA meeting with FDA. That hasn't changed. That was always in the planning.

Current appreciation for the data and whether you can determine if there's controversy within you have to hear about the the quality of the results. Thanks.

Phil This is a I just want to say that this is a an unusual process.

Al Standrock: And some members of the team did get COVID, and I can tell you it's hard to work when you have COVID. The fatigue, mental and physical, was such that there were some people who were affected by the disease.

This is unlike anything I've ever.

Then involved with before my 22 years of.

And so and the nature of this process has been collaboration from the very beginning from the type first type C meeting. So so it's up in a highly collaborative process.

Michelle Venazos: So I think that that's part of it. But I would say that most of it is that I would say the main point is that nothing has come up with the data that has changed our interpretation. We believe eMERGE is a positive study. It was positive on the pre-specified primary and all three secondary endpoints. You know, I mean, we have done analyses on Engage to try to figure out why that result was different, but we believe that the fundamentals are the same and that the potential for approval remains the same, as Michelle said from the very beginning.

I would say and then you know yes submission of documents is easy to say, but the.

The delay is pretty complex a there are multiple sections mall multiple modules and so I know it sounds easy to fill pulled together submission, but let me tell you, it's not and a I think that and it's been difficult to predict the timing, partly because it's been an unusual.

That's right from the beginning and we've always.

You know quite frankly, we bought we've been having type C meeting since last June and this that hasn't changed actually that the the fact that we're doing type C. Meeting has been the same since the very beginning so so those are the main points.

Michelle Venazos: And if something will have changed, we will communicate so.

Ronnie Gao: Our next question comes from the line of Ronnie Gao from Bernstein. Your line is open. Hi, unfortunately, we'll probably have to take the question. We'll stay with the Dukanumab theme.

Our next question comes from the line of Michael Yee from Jefferies. Your line is open.

Hi, Thanks for the question and.

If it hasn't been said before I Hope you guys are very safe you know, how we all know how hard it shipping and handling of time coming any appreciates. It I guess my question is.

Al Standrock: I guess the question is twofold. First one, have there been new questions that have been raised by the data? I mean, we all are familiar with some of the issues you've raised before and how you address them. But essentially, as you kind of look at this, and as the FDA now has an open DNA, might have access to the data, have new questions that have not been raised before by the FDA. And second, should we expect you to present any more data from Adekanema during this year? Any new analysis that you expect to present before we actually get to see the FDA review?

For Al mentioned, the pre B.L.A. meeting I know this is coming up can you just maybe talk about what type of topics for key questions I wouldn't be addressed there and is it safe to say that additional subgroup analyses like any positive versus negative and geographical differences. Those type of analysis have been done and are all part of.

Hi, Thanks, so much.

Well I would say that a read a geographic or issues subgroup analyses that standard practice for every single BLE I've ever been involved in in fact, there sections and them off the call for looking at data from a very.

Phil Nadeau: Ronnie, this is Al. There are really no new questions. As I said earlier, the data, we haven't come up with anything that really changes our interpretation of the data, and so I would say that, fundamentally, there are no big changes and no new questions. And I would also say that we're not planning on presenting anything more publicly at this time, hopefully until approval, but that's our plan.

He is geography, so that's not that's not different from any other BLE I've ever been involved there.

And it had a typical threepl aid meeting you go through its more like an operational meeting you have various sections of the F.D.A. that they're going to be involved in the review of the B.L.A. you sit down and you talk.

Al Standrock: Our next question comes from the line of Phil Nadeau from Kaelin & Company. Your line is open. Good morning.

About how it's going to be submitted what's gonna be submitted exactly and there's some agreement on on the operational aspects of the actual submission. That's the typical previously meeting.

Phil Nadeau: Thanks for taking my question. Again, sticking with the Etiquette and MAB theme, this is, I guess, a two-part question. One is, Just coming back again to what has changed in the Q4 call, it sounded like you said at that time all that needed to happen was some submission of documents. And there was no mention of additional Type C meetings or pre-BLA meetings. I guess, were we all mistaken that you still needed to have those meetings and that was always part of the plan? Or did something come up, again, kind of asking the same question, that prompted the need for those meetings?

Our next question comes from the line.

Hey, Olson from Oppenheimer. Your line is open.

Hi, Thanks for taking my question, it's great to hear your all well and I want to commend you for the work that you're doing dislike coded 19.

I had a question maybe a little longer term question about added can add and as you.

Begin to contemplate home infusion of Tysabri does that set the stage for the potential delivery of added kinda mad by home infusion and will that be done by Biogen employees or are you going to engage a third party to do that thank you.

Al Standrock: And then second, I think what we're all trying to debate here is the FDA's interest in adekinumab. I know you said that there was a high level of interest, but could you maybe give us some better sense of the FDA's current appreciation for the data and whether you can determine if there's controversy within the FDA about the quality of the results. Thanks.

Well home.

And your home infusion of intravenous drugs, it's been in place for decades, I used to prescribe some drugs by home infusion myself back when I practiced and so it's not uncommon.

Whether or not will be done with that you can you add we haven't disclosed yet, but it would not be something that would be difficult to imagine.

It's a it's a very well the infusions themselves are very well tolerated Ah so it would not be difficult to a imagine that.

Michael J. Yee: Phil, this is, I just want to say that this is an unusual process, you know, this is unlike anything I've ever been involved with before in my 22 years at Biogen, so, and the nature of this process has been collaboration, from the very beginning, from the first type C meeting, so, so it's been a highly collaborative process. I would say, and then, you know, yeah, submission of documents is easy to say, but the BLA is pretty complex. There are multiple sections, multiple modules, and so I know it sounds easy to pull together a submission, but let me tell you, it's not, and I think that, and it's been difficult to predict the timing, partly because it's been an unusual process right from the beginning. You know, quite frankly, we've been having type C meetings since last June, and that hasn't changed. Actually, the fact that we're doing type C So those are the main points.

After approval.

Having said that I think that the launching a product in the first Kirby environment would be very a.

Shifting to assess beyond I would say the normality off what we are preparing it on many aspects JBT is to meet beyond digital channels face to face how to engage but also infusion and much more and these were getting ready that to the dynamic going on one he's managing.

The lifecycle of well established product. This is what we're doing but doing very well and the launching a new product in a coffee the environment is a challenge in a plus cause he still yet to be assessed.

Our next question comes from the line.

Evan Seigerman from credit Suisse. Your line is open.

I'll. Thank you for taking the question I'm actually not going ask when and as you can you have I want ask one so yesterday there wasn't appellate court ruling on the 001 patent protected era.

Al Standrock: Our next question comes from the line of Michael Yee from Jeffreys. Your line is open.

Jay Olson: Thanks for the question. And if it hasn't been said before, I hope you guys are very safe. You know, we all know how hard it's been hit. And everyone in the financial community appreciates it.

Highlighting a potential launch about banner Monomethyl fumarate kind of how should we interpret this.

Ruling and if you were to lose one or both of the upcoming district Court cases on Textura, how would you have to protect the franchise.

Al Standrock: Um, I guess my question is for Al, mentioning the pre-BLA meeting. I know this is coming up. Can you just maybe talk about what type of topics or key questions would be addressed there? And is it safe to say that additional subgroup analyses like APB positive versus negative and geographical differences have been done and are all part of this package? Thanks so much.

[noise]. So Evan this is Jeff. So the you know the banner product that product is not a directly sub suitably splash be products I think that's the first thing it's important to understand.

So if it if and when it gets launched.

We don't we don't think there'll be a significant impact at this point in time.

And then with regard to the to court cases, obviously, we're very pleased to get the favorable ruling from the IP are a ruling and I think that's the third time that patent has stood up so we think we've got a pretty strong patent position.

Jay Olson: Well, I would say that geographic issues, subgroup analysis, that's standard practice for every single BLA I've ever been involved in. In fact, there are sections of the MOSH that call for looking at data from various geographies.

Question. However, if were unsuccessful with either the two district court cases.

We've got married is a product that we can kind of look out there's a few months strategy that we're looking at with good growth opportunities around the world in pretty strong results outside the U.S.. We think as somebody has got good growth potential BBU and of course, a you've got the.

Al Standrock: So that's not different from any other BLA I've ever been involved in. At a typical pre-BLA meeting you go through, it's more like an operational meeting. You have various sections of the FDA that are going to be involved in the review of the BLA. You sit down, and you talk about how it's going to be submitted, what it's going to be submitted exactly, and there's some agreement on the operational aspects of the actual submission.

Aducanumab potential as well so.

Well I think we've got a pretty strong franchise will grow grow around it.

Great. Thank you.

Michelle Venazos: Our next question comes from the line of Jay Olson from Oppenheimer. Your line is open. Oh, I thank you for taking my question. It's great to hear you're all well. And I want to commend you for the work that you're doing to fight COVID-19. I had a question, maybe a little longer-term question, about aducanumab. And as you begin to contemplate home infusions of Tysabri, does that set the stage for the potential delivery of aducanumab by home infusions? And will that be done by Biogen employees, or are you going to engage a third party to do that? Thank you.

Our next question comes from the line of Cory Kasimov from JP Morgan Your line is open.

Hey, good morning, guys. Thank you for taking the question.

I guess going back to add you can you map I wanted to better understand what it means to summit modules for your B.L.A. before having that pre BLA meeting or is this I suppose it's always a rolling BLA submission was that the intent all I'm just trying to understand that the meaning and having this pre.

I mean, we didn't think just what's going to be necessary as over the last call. Thanks a lot.

Evan Seigerman: Well, home infusion of intravenous drugs has been in place for decades. I used to prescribe some drugs by home infusion myself back when I practiced them, so it's not uncommon. Whether or not it will be done with aducanumab hasn't been disclosed yet, but it would not be something that would be difficult to imagine. The infusions themselves are very well tolerated, so it would not be difficult to imagine that after approval.

Yeah. So Corey this is out I you know the common technical document is composed of various modules and and there for example quality of modules related.

Manufacturing process, there or nonclinical sections.

And then there's the clinical sections, which culminated in the clinical overview, which is so there are summary documents [noise].

The actual study reports of individual clinical studies.

And so those are the three main sections.

Michelle Venazos: Having said that, I think that launching a product in a post-COVID environment would be very interesting to assess beyond, I would say, the normality of what we are preparing for in many aspects. The ability to meet beyond digital channels, face-to-face, how to engage, but also infusion, and much more. And this is what we are getting ready for. There are two dynamics going on. One is managing the life cycle of well-established products. This is what we are doing. We are doing very well, and launching a new product in a COVID environment is a challenge; launching a new product in post-COVID is still yet to be assessed.

And as you can imagine the Nonclinical was you know it was already kind of ready because not much has been done since a non clinically since the early days are still had to put together the actual documentation. So for so so those are the those are the sections.

The common technical document or they're all submitted electronically and and Ah. So and look we had a starting in around October. So we did start to contemplate submitting modules as they became available that was our plan.

But I'd freebie L.A.

So pretty common practice as I said to get both sides biogen enough yet to.

Evan Seigerman: Our next question comes from the line of Evan Seigerman from Credit Suisse. Your line is open.

Evan Seigerman: Hi all, thank you for taking the question. I'm actually not going to ask one, and as you can, you may have. I want to ask one.

To be agree to have agreement on the operational aspects.

Of the a of the C.T.D., so I would not read very much into that as I said, we had a plan to have that meeting out from the very beginning.

Evan Seigerman: So yesterday, there was an appellate court ruling on the 001 patent for Tecfidera, highlighting a potential launch of the Banner of Monomethylfumarate. Kind of, how should we interpret this ruling? And if you were to lose one or both of the upcoming district court cases on Tecfidera, how would you act to protect the franchise?

You probably have time for about two more questions.

Thank you. Our next question comes from the line of Matthew Harrison from Morgan Stanley. Your line is open.

Hi, Good morning, Thanks for taking my question, sorry to stay on and you came out but I'm really struggling with the the commentary that you're giving this morning. So.

Evan Seigerman: So Evan, this is Geoff. So, you know, the Banner product is not a directly substitutable A-B product. So I think that's the first thing that's important to understand. So if and when it gets launched, we don't think there will be a significant impact at this point in time. And then with regard to the two court cases, obviously, you know, we were very pleased to get the favorable ruling from the IPR, and I think that's the third time that patent has stood up, so we think we've got a pretty strong patent position. However, if we're unsuccessful with either of the two district court cases, you know, we've got Boomeri as a product that we can kind of look at as a fum We've got growth opportunities around the world with pretty strong results outside the U.S. We think SMA's got good growth potential, BBU, and then, of course, you've got the Duke NMF potential as well. You know, I think we've got a pretty strong franchise, and we'll grow around it. Great, thank you.

I was hoping maybe you could just talk about one specific thing I mean, I think your prior guidance was that you would have a filing in early 2020 and today, you're talking about a three Q filing which seems like a significant delay to me yet your characterization seems like nothing has changed and.

And you know sort of all of your expectations are in line. So it seems like there's a significant disconnect with the timeline versus your commentary and I'm I'm just hoping you can maybe take a moment to explain to us what what has happened. Thanks.

[noise] so our goal right from the very beginning was to.

Try to provide estimates or timing of this filing since actually the announcement in October the timing is always not easy to predict and in fact as I said before this is an unusual process. So it's even harder to predict timing when you have a process that that actually is pretty unusual.

Oil and in my in my experience unique I would just say that the constructive engagement, though has been there since the very beginning that continues. These types. The meetings are far more ways to have engagement with F.D.A., a pretty B.L.A. meeting is another formal.

Corey Casimov: Our next question comes from the line of Corey Casimov from JP Morgan. Your line is open.

Corey Casimov: Hey, good morning guys. Thank you for taking the question. Um, I guess I'm going back to AgiCanyon MAP.

Corey Casimov: I wanted to better understand what it means to submit modules for your BLA before having that pre-BLA meeting. Was this always a rolling BLA submission? Was that the intent all along? I'm just trying to understand the meaning of having this pre-BLA meeting. We didn't think this was going to be necessary as of the last call. Thanks a lot.

I'd Ah without the eight to continue on the path to approval or we have an open deal a and Ah yes, there's a.

We said early 2020, so now its Q3, we did have some impact from Cove, it, but I would say that overall, what we're saying is that the pit.

Central for approval, we're still on track with that.

And our next and final question for the day will come from the line of Carter Gould from Barclays. Your line is open good morning, guys. Thanks for taking the question and squeezing me in I guess maybe different.

Al Standrock: The Common Technical Document is composed of various modules. There are, for example, quality modules related to the manufacturing process. There are non-clinical sections. And then there are the clinical sections, which culminate in a clinical overview, which is, so there are summary documents, of the actual study reports of...

Then on the edge Cana My question, obviously, we got cancer him up data Diane to date in the quarter.

Al can you maybe provide your perspective on the appropriateness of reading through from the lack of talking a benefit in that study to educate them up and if these data haven't anyway kind of change the conversations with the FDA. Thank you.

Al Standrock: And so those are the three main sections. And as you can imagine, the non-clinical section was already kind of ready because not much had been done non-clinically since the early days.

Al Standrock: Still, they had to put together the actual documentation and so forth. So those are the sections of the Common Technical Document. They're all submitted electronically.

Thanks Carter the first of all I want to congratulate Randy basement, and all the investigators and Diane too I think it's a it's a beautiful study its it's very hard to do.

Al Standrock: And look, starting in around October or so, we did start to contemplate submitting modules as they became available. That was our plan. But a pre-BLA meeting is still pretty common practice, as I said, to get both sides, Biogen and FDA, to have agreement on the operational aspects of the CTD. So I would not read very much into that. As I said, we had planned to have that meeting from the very beginning.

Because although they are hooked into homogeneous population in terms of they all have autosomal dominant Alzheimer's disease from the genetic and.

Article point of view, it's pretty heterogeneous in terms of clinical they could be two decades, one decade, a few years prior to becoming symptomatic. So how do you pooled data from that heterogeneous clinical collection also it's a relatively small study I'm 50 patients per.

Matthew Harrison: We probably have time for about two more questions. Thank you. Our next question comes from the line of Matthew Harrison from Morgan Stanley. Your line is open. Good morning.

Our arm I believe roughly.

So the Diane to looked at both Solanezumab and gets an era Matt.

So the news AMAP had no change in amyloid Pat based on imaging and there was no effect.

Al Standrock: Thanks for taking the question. Sorry to stay on the adjacent map, but I'm really struggling with the commentary that you're giving this morning. So I was hoping maybe you could just talk about one specific thing. I mean, I think your prior guidance was that you would have a filing in early 2020. And today you're talking about a 3Q filing, which seems like a significant delay to me. Yet your characterization seems like nothing has changed, and, you know, sort of all of your expectations are in line. So it seems like there's a significant disconnect between the timeline versus your commentary, and I'm just hoping you can maybe take a moment to explain to us what has happened. Thanks.

So that's not too surprising catching on that did have an effect on amyloid.

However, I want to compare the magnitude of the effect between cancer, there, Matt and as you can you, Matt and the only way to do that really is to use this center Lloyd scale. The whole point of the center Lloyd its develops so that you can compare across studies because people use different Pat lie gans people have different referenced regions.

If they use to to the ER to obtain the S you'd be our score in the Prime study a 10 milligrams per kilogram of add to Canyon map was associated with a change in the center Lloyd scale of about 57, a in one year.

And the dot and the Diane to study go.

Can't an air map was associated with the change from baseline of about 14 cents avoid units over four years. So I think that's pretty different.

Al Standrock: So, our goal right from the very beginning was to try to provide estimates. The timing is always not easy to predict, and, in fact, as I said before, this is an unusual process. It's even harder to predict timing when you have a process that is actually pretty unusual and, in my experience, unique. I would just say that constructive engagement has been there since the very beginning. That continues.

And Ah I think the main point that we were trying to make at the Sicad meeting is that dose matters.

And that the robustness of amyloid removal.

Matters and we saw that in the data and I think we presented that so in some ways.

I looked on the Diane two data and I think it kinda confirms what we I've been saying that you have to have a high doses and robust removal of amyloid in order to see a clinical benefit.

Al Standrock: These type C meetings are formal ways to have engagement with FDA. A pre-BLA meeting is another formal meeting with FDA to continue on the path to approval. We have an open BLA, and yes, there's a reset in early 2020, so now it's Q3. We did have some impact from COVID, but I would say that overall, what we're saying is that the potential for approval, we're still on track with that.

I'll turn it over to Michel for some closing comments. Thanks, everybody. So thank you all are flattening the cold I would like to say that to even if the person that he affected by diesel variable funding Meek Biogen is demonstrating super Brazilians.

Biogen, even stronger today, and we are well positioned for the future.

Nothing we that you can you mob, but also looking forward to all the important readouts in the coming period.

Carter Lewis Gould: And our next and final question for the day will come from the line of Carter Gould from Barclays. Your line is open. Good morning, guys.

Thank you everybody.

Ladies and gentlemen, thank you for participating. This concludes today's conference call you may now disconnect.

Al Standrock: Thanks for taking the question and squeezing me in. I guess maybe a different spin on the adjucanumab question. Obviously, we got gantorimumab data and diane-2 data in the quarter. Al, can you maybe provide your perspective on the appropriateness of reading through from the lack of cognitive benefit in that study to adjucanumab and if these data have in any way changed the conversations with FDA? Thank you

[noise].

Michelle Venazos: Thanks, Carter. First of all, I want to congratulate Randy Bateman and all the investigators and Diane, too.

Al Standrock: I think it's a beautiful study. It's very hard to do, because although they are, it's a homogeneous population in terms of they all have autosomal dominant Alzheimer's disease from the genetic and biological point of view, it's pretty heterogeneous in terms of clinical, they could be two decades, one decade, a few years prior to becoming symptomatic, so how do you pool data from that heterogene Also, it's a relatively small study, 50 patients per arm, I believe roughly. So DIANT2 looked at both solanuzumab and gantanerumab. Solanuzumab had no change in amyloid PET based on imaging, and there was no effect. So that's not too surprising.

Al Standrock: Gantanerumab did have an effect on amyloid PET, but I want to compare the magnitude of the effect between gantanerumab and aducanumab. And the only way to do that, really, is to use the stentholoid scale. The whole point of the stentholoid scale is that it was developed so that you can compare across studies because people use different PET ligands. People have different reference regions that they use to obtain the SUVR score. In the prime study, 10 milligrams per kilogram of aducanumab was associated with a change in the stentholoid scale of about 57 in one year. In the Diane 2 study, cancer nerumab was associated with a change from baseline of about 14 centroloid units over 4 years.

Al Standrock: So I think that's pretty different, and I think the main point that we were trying to make at the CTAD meeting is that this matters, and that the robustness of amyloid removal matters. And we saw that in the data, and I think we presented that. So, in some ways. I look at the Dian-2 data, and I think it kind of confirms what we have been saying, that you have to have high doses and robust removal of amyloid in order to see a clinical benefit.

Michelle Venazos: I'll turn it over to Michelle for some closing comments. Thanks, everybody.

Michelle Venazos: Thank you all for attending the call. I would like to say that even if I have personally been affected by this terrible pandemic, Biogen is demonstrating superb resilience. Biogen is even stronger today, and we are well positioned for the future, starting with aducanumab, but also looking forward to all the important readouts in the coming period.

Michelle Venazos: Thank you, everybody. Ladies and gentlemen, thank you for participating. This concludes today's conference call. You may now disconnect.

unknown: BF-WATCH TV 2021

unknown: The Ultimate Parody Site!

unknown: BF-WATCH TV 2021 (inaudible) BF-WATCH TV 2021