Q2 2020 Biogen Inc Earnings Call

Operator: Thank you. I would now like to turn the conference over to Mr. Joe Marra, Vice President, Investor Relations. You may begin your conference. Good morning, and welcome to Biogen's second quarter 2020 earnings call. Before we begin, I encourage everyone to go to the Investors section of Biogen.com to find the earnings release and related financial tables, 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 GAAP and non-GAAP financial results and our GAAP and non-GAAP financial guidance. We believe non-GAAP financial results better represent the ongoing economics of our business and reflect how we manage the business internally. We've also posted slides on our website that follow the discussions related to...

All lines have been placed on mute to prevent any background noise.

After the speaker's remarks, there will be a question answer session. If he would like you're asking question. During this time simply from stores and the number one on your telephone keypad refund that yourself to one question to allow other participates time for questions.

We require any further follow up you May press star one again to rejoin the queue.

Thank you I would now like to turn the conference over to Mr., Joe Moore, Vice President Investor Relations you May begin your conference.

Good morning, and welcome to buyers in second quarter 2020 earnings call.

We begin I encourage everyone to go to investors section of margin Dotcom finding earnings release, it related financial tables, putting a reconciliation of the GAAP non-GAAP financial measures that will discuss today.

Operator: 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 Bonacos, Dr. Al Sandrock, EVP, Research and Development, and our CFO, Jeff Capello. Now, I will turn the call over to Michelle.

GAAP financials are providing people wanting to if people Threeq was a reconciliation of GAAP non-GAAP financial results and our GAAP non-GAAP financial guidance.

We believe non-GAAP financial results better represent the ongoing economics of our business and reflect how we manage the business internally.

Michelle Bonacos: Good morning.

Michelle Bonacos: Good morning, everyone, and thank you for joining us. With a focus on strong execution, we have continued to serve patients. At events, there was strategic priority and delivered another strong financial quarter. Let me begin with some important developments. First, we have... Our submission for U.S. approval of aducanumab, an unprecedented opportunity for patients and for biotech to potentially bring the first therapy to market. Devastating Clinical Decline and Meaningfully Changed the Course of Alzheimer's Disease. I am incredibly proud of the Biogen team. Education and Tyler's work leading to the of our regulatory submission on July 7th. This submission is for ongoing collaboration with the FDA and includes data from a comprehensive clinical development program including eMERGE, the first positive phase 3 study ever in this space. Together, we are supporting data from the Phase III Engage Study and positive results from the Phase I B-Prime Study. Our data show that adecadimab may help to both reduce the decline of cognitive function and help patients' ability to perform certain activities of daily living, which for some patients may result in independence for a longer period of time.

As opposed to slides on our website following discussions really.

I would 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 actual results may differ materially.

I heard you to consult the risk factors as governor FCC filings for additional detail.

Today's call I'm joined by Archie Chief Executive Officer, who show when ourselves soccer Al Sandrock, CVP research and development and our CFO, Jeff Capello now I will turn the call over to Michelle.

Good morning, everyone and thank you for joining us.

We just focus on strong music and we have continued to some patients advance. So it was couldn't you for your risky.

I know the strong financial quarter.

Let me begin we've told me Bolton developments.

We have completed I wish submission for U.S. approval off because the mob.

Unprecedented football three people patients and whole Biogen.

He bring to market.

So I'd be reduced so devastating can you could decline and meaningfully change the pull something like that.

Hi, I'm incredibly proud of the Biogen team.

And on this one leading to the completion.

Well it though resubmission on July seven.

He submission for ongoing collaboration with your <unk> and includes they go from Occupancies can you could develop and pull com, including emerge. The first party fish, we study ever empty space.

Michelle Bonacos: In terms of next steps, we anticipate receiving a response from the FDA within 60 days from the submission date, notifying us if the submission has been accepted, and if accepted, whether we have been granted priority review. We plan to communicate both of these decisions via a press release. We have progressed in our U.S. launch readiness, including increasing our medical engagement with experts and thought leaders to better assess how aducanumab could potentially impact clinical practice. We have started to make progress engaging with payers and defining EducatingMaps' value proposition, and we have now established a cross-functional team dedicated to site readiness, which is currently operational.

Whether we should booking data from the C suite engage study and what do you see results from the phase one be prime study.

I would they don't show that I, just couldn't mob may help to board reduce the decline of couldn't be function and help patients ability to perform certain activities of baby, leaving which for some patients may result in independence for a longer period of time.

In terms of next steps, we anticipate receiving a response from the have you. We didn't 60 days from the submission date notifying us even <unk> mission has been accepted.

And if accepted whether we had been granted priority review.

We plan to communicate to both of these decisions, we got a press release.

Michelle Bonacos: Outside the U.S., we made significant progress this quarter. We had formal meetings with EU regulators as we prepare to submit the filing, and we are beginning to ramp up our launch readiness efforts in Europe. In Japan, we had informal regulatory interaction and are preparing for formal consultation with the PMDA.

We have progress you know a U.S. launch readiness, including increasing our medical engagement with express until Akita's stupid to us is how educating mob could potentially impact can you could practice.

We have started to make progress engaging with figures and you find that you're getting about the value proposition and we have now established it cross functional team dedicated to side to readiness, which is currently operational.

Michelle Bonacos: Overall, together with our collaboration partner, SI, we remain optimistic about the prospect of bringing aducanumab to market as the first therapy to meaningfully change the course of Alzheimer's disease, and we have continued to progress in our market preparation and long-treadiness with an initial focus on the U.S. We believe that aducanumab marks the beginning of an era of new potential treatment for Alzheimer's disease and we aim to build a broad franchise across multiple targets and modalities. This includes band 24-1 in phase 3, which we are collaborating on with SI, including a new study in preclinical Alzheimer's. Multiple programs targeting Tau and our collaboration with Sangamo to develop gene regulation therapies for a range of neurological indications, including Alzheimer's disease.

Outside the U.S., we made significant progress this quarter, we hot formal meetings, we didn't you regulators as we prepare to semi defining and we are beginning to ramp up our launch where he knows if 14 Europe.

In Japan, we had in formula figured out the wind direction and preparing for former called tradition, we the P. M D.

Overall together with our collaboration partner is site, we remain optimistic about the prospect of bringing I'd, you're getting up to market.

The first therapy to meaningfully change the calls offers that movies and we have continued to progress you know with market preparation and launch readiness. We then any Sean focus on the U.S.

We believe that said you're getting my marks the beginning of an era of new potential treatment ones I'm as disease, and we aim to build he brought franchise across multiple targets and modalities.

Michelle Bonacos: We believe Biogen is uniquely positioned to lead the fight against Alzheimer's disease over both the short and the long term. Second, we are disappointed in the recent court decision in West Virginia regarding our patent for Tecfidera. We are appealing this decision and intend to vigorously defend our IP. No matter what the final outcome will be, we still believe Biogen is well-positioned for shareholder value creation as we work to capitalize on growth opportunities in our core business and continue to grow. Biogen was uniquely positioned and the time is now for Biogen to lead in the evolution of this space. We have a deep pipeline of 29 clinical assets, including seven in phase three or filed and seven meet to late stage data readouts by the end of 2021, with near-term value creation opportunities beyond Alzheimer's disease in other important areas such as ALS, ophthalmology, lupus, and stroke.

This includes about 24 wanting phase three which we are collaborating on we the site, including new study in preclinical diamonds.

Super Poke I'm stuck it think though and I will collaboration we sangamo to develop gene that regulation therapies for a range of know what did you call indications, including as I'm a disease.

We believe Biogen is uniquely positioned to lead the fight you know so I'm as ease over bull, so short and long term.

Second we are disappointed in the recent called decision in West Virginia regarding other buttons, what the fees are up we are appealing the decision and intends to vigorously defend our IP.

No matter what the final outcome, we'd be we still believe biogen is well positioned for shareholder value creation as we work to capitalize on growth for both Green teas, you know called business and.

[noise] uniquely position and at the time is known for Biogen to lead in the evolution of the space.

Michelle Bonacos: Third, as we announced yesterday, Geoff will be stepping down as CFO in August. I'd like to thank him for his many contributions to the company, including establishing a very strong team, helping to deliver consistent results quarter over quarter, strengthening our finance processes and operations, and creating a disciplined cost management culture. We are pleased that Geoff will be staying on for a brief period to ensure a seamless transition.

We have a deep pipeline of 29 clinical assets, including seven in phase three of filed and seven mid to late stage data read out by the end of 2021.

We need some value creation opportunities beyond Alzheimer's disease in all the important areas such as a less often moto GP lupus and stroke.

Michelle Bonacos: We wish him well in his future endeavors. I will now review our Q2 performance and progress against our strategic priorities. Compared to the same period a year ago, second quarter revenues grew 2% to $3.7 billion. Second quarter GAAP earnings per share grew 22% to $9.59, and non-GAAP EPS grew 12% to $10.28.

Third as we announced yesterday, just we'd be stepping down us yet for in August I'd like to thank Jeff well. He's many contributions for the company, including establishing a very strong team helping to the people call. She stunt results quarter over quarter strengthening over finance processes.

An operations and creating a disciplined cost management couture.

We are pleased the Jeff would it be staying on for a brief very odd to ensure a seamless transition.

Michelle Bonacos: Importantly, we saw improved momentum in June following an impact from COVID-19 earlier in the quarter. Q2 MS revenues, including Ocrevus royalties, were $2.3 billion. The number of patients on our MS product globally increased 3% versus the prior year, and our business continues to demonstrate resilience. We saw strong market share performance for our MS portfolio this quarter, with an increased share of new prescriptions in the U.S. and stabilized market share in Europe. Overall, our fumarate products had a strong quarter as we focused on maximizing the potential for Texfidera and bumeriti combined.

We wish him well in he's future endeavor.

I will now review, our Q2 performance and progress against that was caught did you priorities.

Compared to the same go to your goal second quarter revenues grew 2% to 3.7 billion dialogue second quarter GAAP earnings per share grew 22% to nine dialogue and 59 cents and non-GAAP EPS grew 12% to then do laws and 28 cents.

Importantly, we saw improved momentum in June following an impact from could be 19 build your in the quarter.

First.

<unk>, and that's where the news, including awkwardly swayed he's with $2.3 billion. The number of station on our M.S. put a bloody increased 3% virtusa, probably your and our business continued to demonstrate resilience. We saw strong market share performance fall in this portfolio this quarter we.

Michelle Bonacos: Although we were disappointed in the performance of Emeriti, it's important to note that the MS market in the U.S. has been significantly impacted by lower new patient starts and switches due to COVID-19, as well as reduced engagement with physicians, which have both impacted the launch of Emeriti. Importantly, we believe the market is increasingly aware that Vumerity is clearly differentiated in terms of better GI tolerability and may represent a better treatment alternative for many MS patients. Going forward, our strategic focus is now on the U.S., and we are increasing our resource allocation to maximize this next generation FEMA rate. We are hopeful that this approach, combined with the potential recovery in the dynamic portion of the market, will help improve Emeriti's trajectory in the second half of this year. Outside of the U.S., this quarter, we were very pleased to have submitted regulatory filings for the Emirates in Canada and Switzerland, and we plan to file in the EU by the end of this year.

Increase share of new prescriptions in the U.S. and stabilize marketshare in Europe.

Overhaul or I will see my right products had a strong quarter as we focus on maximizing the potential for <unk> and humidity combine all.

Although we were disappointed in the performance will be may Ricky it's important to note that the M.S. marketing. The U.S. has been significantly impacted by lower new patient starts and switches due to cover 19, as well as reduced engagement with physicians, which huh.

Both impacted the launch will be memory T.

Importantly, we believe the market is increasingly aware that we maybe tees clearly differentiated in terms of better G. I totally Abili T.

In may represent a better treatment has done a key for many emmis patients.

Going forward I was how difficult because he is now on if you may Ricky and we are increasing a resource allocation to Maximise. These next generation FEMA right.

Michelle Bonacos: A critical part of our strategy in MS is, and will continue to be, investing in lifecycle management and innovative new approaches to help address the remaining unmet medical needs. We look forward to the readout of OPC-NUMAB this year, which could represent a transformative new approach to slowing, or even potentially reversing, disability progression through remuneration. In addition to OPC-NUMAB, we continue to advance BIP-61, an oral remuneration therapy, and BIP-91, an oral BTK inhibitor with a potentially best-in-class profile, and we believe these important assets will bolster our broad portfolio of treatments for MS going forward. Across our current MS products, our focus on life cycle management is a high priority.

We are hopeful that this approach combined with the potential recovery in the dynamic portion of the market will help improve the merit to subject to read into second half of these.

Outside of the U.S. This quarter, we were very pleased to have should be to the regulatory filing probably memory T in Canada, and Switzerland, and we plan to file indeed, you buy deanna will be sure.

[laughter] sorry, it typically pop of always Pathie Gms ease and we continue to be investing in lifecycle management and innovative new approaches to help address the remaining unmet medical needs. We look forward to the readout of RBC, new mob would be sure.

Which could represent to transform achieved new approaches slowing or even potentially reversing disability progression who remain nation.

Michelle Bonacos: We recently filed for approval of a subcutaneous formulation of... for the U.S. and EU to offer a competitive dosing profile in the high-efficacy space. We continue to advance the potential use of extended interval dosing for disabling. We are advancing an intramuscular formulation of plaguity to potentially improve its tolerability profile, and we are leveraging label updates regarding the use of interference during pregnancy. We remain committed to MS, and regardless of the outcome of the tech federal litigation, we are focused on maximizing the broad opportunities we have with both present and future product offerings.

In addition to be senior mob, we continue to advance beeps 61.

And overall remain nation therapy, and beep 91, an oral BTK inhibitor, we the potentially best in class profile and we believe these important assets bolster our broad portfolio of treatments for immense going forward.

Across our current them as products I will focus on lifecycle management ease a high priority.

We recently filed for approval of because she continues formulation.

For the U.S. and you to offer a competitive dosing profile into how you feel because he space.

We continue to advance the potential use of extended into about dosing put my summary.

Michelle Bonacos: Second Spinoza, It's been Rasa generated second quarter global revenues of $495 million, a 1% increase versus the prior year. We are pleased with this performance in light of dosing delays due to COVID-19, which peaked in mid-April and began to normalize in May and June. Including the expanded access program and clinical trials, over 11,000 patients are being treated with Spinraza, an increase of 30% versus the prior year. This quarter, we presented important new data at the virtual CURE SMA meeting showing an unprecedented benefit on survival for pre-symptomatic SMA patients treated with Spinraza. Data from the neutral study continue to demonstrate the compelling benefits PINRASA can provide to patients. This follows the publication of independent, real-world data earlier this year demonstrating the clinically meaningful benefits PINRASA can deliver for teens and adults, which represent the largest portion of the market. Spinraza continues to be the only therapy approved for SMA patients of all ages, with clinically meaningful and sustained efficacy across all age groups. We recently announced our plans to initiate a new clinical study evaluating the safety and efficacy of Spinraza when administered to infants following gene therapy.

We are advancing an income is could off formulation of liquidity to potentially improve each study hobby leaky profile.

And we are leveraging label update regarding the use of interferons during pregnancy.

We remain committed to a mess and regardless of the outcome of the six either relegation we are focused on maximizing the broader opportunities. We have we both present and future product offerings.

Second Spinraza.

You must have generated second quarter <unk> global revenues of $495 million off a 1% increase whats user probably your.

We we are pleased with these performance in light of dosing delays due to cover 19, which peaked in mid April and began to normalize in may and June.

Including the expanded access program in clinical trials over 11000 patients are being treated to be spinraza, an increase of 30%. The shoes are probably your.

This quarter, we presented important new data I didn't get cure cure SMB meeting showing an unprecedented benefit on survival for Presymptomatic SMB patients treated we spinraza.

It does from the from the neutral study continue to demonstrate the compelling benefits been rise that can provide two patients.

These follows the publication of independent real World data earlier, this year, demonstrating the clinically meaningful benefits been runs that can deliver.

Michelle Bonacos: I believe there is a strong scientific rationale and a high need to evaluate the potential added benefit of Spinraza in this population. We have seen real-world demand for Spinraza in this setting, with 40% of patients in the long-term extension of the Phase I study of gentropy going on to receive Spinraza. Further, in our Life Cycle Management for SMA, we are also investigating whether a higher dose of Spinraza could result in even greater efficacy through the DEVOTE study.

Teens, and others, which represent the largest portion of all of the market.

It's been rods that continues to be the only therapy approved for SMB patients.

All ages, we clinically meaningful and sustainable because she across all age groups.

We recently announced our plans to initiate a new clinical study evaluating the safety and efficacy or spinraza when administered to infants following gene therapy.

We believe there is a strong scientific rational and a high need to evaluate the potential I did benefit of Spinraza in this population.

Michelle Bonacos: Third, Biosimilar's revenues for the second quarter were $172 million, as we observed an impact from COVID-19, particularly early in the quarter. We estimate that our biosimilar 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 important as we work to create financial headroom for innovation and contribute to the long-term sustainability of the healthcare system. In addition, Samsung Bioepis recently initiated a phase 3 study for our potential biosimilar, ILEA, as we work to expand into ophthalmology and additional geographies, including Japan and the U.S. Fourth, beyond Alzheimer's disease, we continue to progress our pipeline. Initiating a new Phase I study in movement disorders, we presented positive first-in-class data for BIP59 in cutaneous lupus erythematosus, and the positive Phase I-II results for Tofersen in SOD1 ALS were published in the New England Journal of Medicine.

We have seen rewards demand for Spinraza, Andy setting, we will keep percent of patients in the long term extension of the phase one study of gene therapy going on to receive Spinraza.

Further you know lifecycle management Tina semi we are also investigating whether how your daus spinraza could result, even greater efficacy to that you bought study.

Third, but you'll see me, that's where the news for the second quarter Award were $172 million as we observed an impact from could be 19, particularly early in the quarter.

Estimate that that were biosimilars generated approximately 1.8 billion euros of savings to the European Heska systems in 2019, which we expect we continue to increasing Twentytwenty. This is important as we work to create potential headroom for innovation and contributes to the long term sustainability of the has consistent.

In addition, Samsung, but you only piece recently.

Thank you the phase three study for our potential but you'll see me now referencing alia as we work to expand into automotive Gi and additional geographies, including Japan and B U S.

Michelle Bonacos: Our cash flow generation remains strong and continues to provide us with significant optionality and flexibility to allocate capital. In Q2, we generated approximately $2 billion in cash flow from operations. We have $5.3 billion in cash and marketable securities on the balance sheet, providing us with the financial flexibility to continue to evaluate external business development and M&A opportunities. As we have demonstrated in the past, we are committed to maximizing returns for our shareholders as we aim to bring innovative therapies to patients. Something that demands a thoughtful approach to all our investment over both the short and the long term.

Fourth beyond Alzheimer's disease, we continue to progress our pipeline we in shade did in new Phase One study movement disorders. We presented positive first in class ticked up a beep 59 include Tony should appreciate my twos and the positive phase one two results photofix and in a suit.

The one HLS with published in New England will not have committed.

Yes, I with cash flow generation remain strong and continue to provide us with significant optionality and flexibility to allocate capital in Q2, we generated approximately $2 billion in cash flow from operations.

Michelle Bonacos: In summary, Biogen has continued to execute well on our strategy, including the recent BLA submission for aducanumab in the U.S. While we are mindful of the potential risk to Tecfidera, we believe we are well positioned as we continue to build a multi-franchise portfolio, leveraging the interconnectivity of our deep neuroscience pipeline. We expect seven important meet-to-late-stage readouts by the end of next year, and we have several opportunities for meaningful value creation in areas of high and medical need beyond Alzheimer's, including ALS, ophthalmology, lupus, and stroke, as well as continued innovation in MS and SMA. I will now turn the call over to Al for a more detailed update on our recent progress in R&D.

We have $5.3 billion in cash and marketable securities on the balance sheet, providing us with the financial flexibility to continue to evaluate external business development and M&A opportunities.

As we have demonstrated in the past we are committed to maximizing returns for shareholders. As we aim to bringing about you therapies to patients something that demands so twin approach towards all our investment over both the short and long term.

In summary, Biogen has continued to execute well on I was fatigue, including the recent beauty submission Ford you can you maybe in the U.S. why do we are mindful of the potential risks to fix either we believe we are well positioned as we continue to be lead me to franchise portfolio leveraging the interconnect TV Q4, we keep neuroscience pipe.

Geoffrey Christopher Meacham: I would like to start by thanking the Biogen team for their hard work as they continue to advance our R&D programs during these challenging times. Although some uncertainty remains about the impact that COVID-19 is having on our studies, I'm pleased that the majority of our clinical trials are currently on track or only slightly delayed, with seven mid- to late-stage readouts expected by the end of next year. Let me now turn to the progress we made across our pipeline in the second quarter.

Line, we expect seven important mid to late stage read outs by end of next year.

And we have several opportunities for meaningful value creation in areas of high unmet medical need beyond Alzheimer's, including a less often moto GP lupus and stroke as well as continued innovation in the mess and estimate.

We'll now turn the corner over to pilot for a more detailed update on our recent progress in R&D.

Thank you Michelle.

Geoffrey Christopher Meacham: Starting with Alzheimer's disease, as Michelle mentioned, we have completed the BLA submission for aducanumab to the FDA. This submission is based on eMERGE, the first positive phase 3 study for a therapy to reduce clinical decline in Alzheimer's disease. Supporting data from ENGAGE, although this study did not meet its primary endpoint, and positive results from the Phase 1b PRIME study. We participated in a pre-BLA meeting with the FDA, during which the agency reiterated that submitting a BLA based on data from eMERGE, Engage, and Prime was reasonable. We look forward to working with the FDA during their review and continuing our engagement with other regulators around the world. I want to congratulate the team for achieving this important milestone in the midst of the COVID-19 crisis.

I would like to start by thanking the Biogen team for their hard work as they continue to advance our R&D programs. During these challenging time.

Although some uncertainty remains on the impact that cobot 19 is having on our studies I'm pleased that the majority of our clinical trials are currently on track for only slightly delayed seven mid to late stage Readouts expected by the end of next year.

Let me now turn to the advances we made across our pipeline in the second quarter.

Starting with all climbers disease as Michelle mentioned, we have completed the BLE submission for as you can you map to the FDA.

This submission is based upon emerge the first positive phase three study for therapy to reduce clinical decline in Alzheimer's disease supporting data from engage although this study did not meet its primary endpoint and positive results from the phase one be prime study.

Geoffrey Christopher Meacham: We also continue to develop a broader Alzheimer's disease portfolio and believe we are well positioned for sustained leadership in this disease area. Part of this strategy includes expanding into even earlier patient populations with the goal of delaying or perhaps even preventing the clinical onset of the disease. To that end, our collaboration partner ASCI, in conjunction with the Alzheimer's Clinical Trial Consortium, announced the initiation of the AHEAD 345 clinical study to evaluate BAN 2401 in individuals with preclinical Alzheimer's disease. These individuals have intermediate or elevated levels of amyloid in their brains.

We participated in a pre BLA meeting with the FDA during which the agency reiterated that submitting a B.L.A. based on data from emerge engage and prime was reasonable.

We look forward to working with the FDA during their review and continuing our engagement with other regulators around the world.

I want to congratulate the team for achieving this important milestone in the midst of the club at 19 crisis.

We also continue to develop a broader all simers disease portfolio and believe we are well positioned for sustained leadership in this disease area.

Geoffrey Christopher Meacham: Together, the A3 and A45 studies will evaluate whether early administration of BAN2-401 can suppress the progression of amyloid and tau pathology and reduce cognitive decline in the very early stages of Alzheimer's disease. The results of the BAN2-401 Phase 2 study, as well as the similarities between BAN2-401 and aducanumab, give us reason to be optimistic regarding the ongoing Phase 3 study for BAN2-401. Beyond amyloid beta, we continue to advance several programs aimed at different drug targets, including tau, which, when misfolded, is the principal constituent of neurofibrillary tangles, a hallmark of Alzheimer's path The accumulation and spread of misfolded tau in the brain correlates with disease progression and may make it amenable to clearance via antibody-based approaches, which we believe target extracellular forms of the protein.

Part of this strategy includes expanding into even earlier patient populations with the goal of delay or perhaps even preventing the clinical onset of disease.

To that end our collaboration partner as site in conjunction with the Alzheimer's clinical trial consortium announced initiation of the ahead three four or five clinical study to evaluate band to four O one and individuals with preclinical Alzheimer's disease.

These individuals have intermediate or elevated levels of amyloid in their brings.

Together, the Athree and a four or five studies well evaluate whether early administration of band two for one can suppressed the progression of amyloid and tell pathology and reduce cognitive decline in the very early stages of all samaras disease. The results of the ban to for a one phase two study as well as a sim.

Polarities between band to for a one and as you can you Matt give us reason to be optimistic regarding the ongoing phase three study for band to for a one in early all frameless disease.

Geoffrey Christopher Meacham: Our lead Tau asset is Gosaranumab, a monoclonal antibody currently in a Phase II study in Alzheimer's disease. This study is fully enrolled, with data expected in the first half of next year. In addition to Gosaranumab, we also have BIP-76, a distinct anti-tau antibody in Phase 1. We're also advancing our ASO targeting tau BIP-80, which may reduce the synthesis of all forms of the protein, both intracellular and extracellular. Moving to our MS portfolio, we continue to advance a number of initiatives aimed at further unlocking the value of our existing franchises.

Beyond amyloid beta we continue to advance several programs aimed at different drug targets, including Tao, which when Misfolded is the principal constituent of Neurofibrillary tangles, a hallmark of all clamorous pathology.

The accumulation and spread of Misfolded toe in the brain correlates with disease progression and may make it amenable to clearance via antibody based approaches, which we believe target extra cellular forms of the protein.

Our lead towel asset is go saran among a monoclonal antibody currently in a phase two study and all famous disease. This study is fully enrolled with data expected in the first half of next year.

Geoffrey Christopher Meacham: To that end, we presented new data across our MS portfolio at the AAN meeting in May. Among the data presented were new data on Tysabri, which supported previous findings that extended interval dosing is associated with a lower incidence of PML and may maintain comparable efficacy as assessed by serum neurofilament light biomarkers. The efficacy of extended interval dosing as compared to the standard dosing regimen is being assessed prospectively in the ongoing NOVA study, which has an expected readout in the first half of next year. In addition, we are pursuing what we hope will be transformative approaches in MS.

In addition to go surround them and we also have bip 76 distinct anti Tau antibody in phase. One we're also advancing our area. So targeting targeting title that 80, which may reduce the since synthesis of all forms of the protein both intra cellular and extra cellular.

Moving to our MSR portfolio, we continue to advance a number of initiatives aimed at further unlocking the value of our existing franchise.

To that end, we presented new data across our M.S. portfolio at the end meeting in May.

Among the data presented where new data on Tysabri, which supported previous findings that extended interval dosing is associated with a lower incidence of PML.

Geoffrey Christopher Meacham: The most advanced asset in our MS pipeline is opicinumab, or antilingual, which is a potential first-in-class remyelination agent to promote neuronal repair and potentially reverse disability in MS. The safety and efficacy of opicinumab as an add-on to existing disease-modifying therapies in MS are currently being evaluated in a Phase IIb affinity trial. Affinity takes advantage of data from the prior Synergy Phase II study in MS and a subsequent post-hoc analysis to identify what we believe are additional criteria needed to identify the right patients, the right dose, and the right measurements to assess the therapeutic potential of opicinumab. We also have an oral remyelination agent, VIB-061, in Phase 1 that has a target distinct from that of anti-lingo. Additionally, we have BIB-91, a small molecule BTK inhibitor, in Phase 1.

Maintain comparable efficacy as assess partner CRM neuro filament light biomarkers.

The efficacy of extended interval dosing as compared to the standard dosing regimen is being assessed prospectively in the ongoing Nova study, which has an expected readout in the first half of next year.

In addition, we are pursuing what we hope will be transformative approaches NMS. The most advanced asset in our M&A pipeline as Opie cinemark or anti lingo, which has a potential first in class remodel a nation agent to promote nurown or repair and potentially reverse disability in a mess.

The safety and efficacy of up you send them as an add onto existing disease modifying therapies. NMS is currently being evaluated in the phase to be affinity trial.

Affinity takes advantage of data from the prior synergy phase two study in a mess and a subsequent post talk analysis to identify what we believe our additional criteria needed to identify the right patients the right dose and the right measurements to assess the therapeutic potential to focus sentiment.

Geoffrey Christopher Meacham: We believe that BIB-91's highly potent and selective non-covalent inhibition of BTK may make it a best-in-class molecule. Turning to neuromuscular disorders, we presented an update on the ongoing NURTURE study at the CURE SMA meeting this last month. NURTURE, which is the longest study ever done on the treatment of pre-symptomatic patients with SMA, evaluates nuisance and infants who had initiated treatment shortly after birth and prior to the onset of symptoms. The new analysis shows that all 25 or 100% of children up to 4.8 years of age were alive and remained free of permanent ventilation, with 88% walking independently and 96% able to walk with assistance.

We also have an oral remind nation agent bid zero 8061 in phase one that has a target distinct from that of anti lingo.

Additionally, we have bid 91, a small molecule BTK inhibitor in phase one we believe that bid 90 ones highly potent and selective non covalent non covalent inhibition of be Teekay may make it a best in class molecule.

Turning to neuromuscular disorders, we presented an update on the ongoing nurture study at the cure Esa May meeting this last month.

Geoffrey Christopher Meacham: We are pleased to report that the U.S. label for nusinersen was recently updated to include the additional data gathered in the NURTURE study. In ALS, the results from the Phase 1-2 trial of Tefercin in patients with genetic ALS due to mutations in SOD1 were published in the New England Journal of Medicine this month. This study showed promising signs of efficacy across multiple clinical and biomarker endpoints. We are encouraged by these results and look forward to the results of the ongoing Phase 3 VALOR study, which is expected to read out late next year. We believe that the Tuferson results have positive implications for our other assets for ALS, including PIB78 for ALS due to mutations in C9-ORF, the most common genetic cause of the disease, as well as our program targeting Ataxin-2.

Nurture, which has the longest study ever done on the treatment of pre symptomatic patients with estimate evaluates new centers in infants, who had initiated treatment shortly after birth and prior to the onset of symptoms. The new analysis showed that all 25 or 100% of children up to 4.8 years of age we're alive.

Remain free of permanent ventilation with 88% walking independently and 96% able to walk with assistance.

We're pleased to report that the U.S. label of Newson Urson was recently updated to include the additional data gathered in and nurture study.

In a less the results from the phase one two trial up to person in patients with genetic a student mutations and so do you one were published in the New England Journal of Medicine. This month.

This study showed promising signs of efficacy efficacy across multiple clinical and biomarker endpoints. We are encouraged by these results and look forward to the results of the ongoing phase three valor study, which is expected to read out late next year.

Geoffrey Christopher Meacham: Next, I would like to turn to the encouraging progress we are making in lupus. Last month, at the European College of Rheumatology meeting, we presented results from our Phase II Lilac Study, evaluating the safety and efficacy of BIV-50 and BIV-59, a fully humanized monoclonal antibody targeting BDCA2, in individuals with active cutaneous lupus erythematosus, or CLE VIB-59 treatment resulted in a dose response on the Classy A score, a well-defined and reliable outcome measure to detect CLE skin disease activity.

We believe that the to first didn't results have positive implications for other assets for LSW, including Pip 78 for HLS duty mutations and cnine or the most common genetic cause of the disease as well as our program targeting eightx and too.

Next I would like to turn to the encouraging progress we're making in lupus.

Last month at the European College of Rheumatology meeting, we presented results from our phase two lilac study evaluating the safety and efficacy of below 50% 59, a fully humanized monoclonal antibody targeting BDCA too and individuals with active cutaneous lupus erythematosus or Sidoti.

Geoffrey Christopher Meacham: Specifically, study participants with CLE treated with BIF-59 showed statistically significant reductions in Classy A score at Week 16 versus placebo, with a p-value on the primary endpoint of less than 0.001. BIV-59 was discovered and developed by biogen scientists and has the potential to be the first anti-BDCA2 antibody for the treatment of lupus. We plan to initiate a Phase III program for BIV-59 in the first half of next year. In collaboration with our partner UCB, we aim to start a Phase 3 program for Deporolizumab Pegol in patients with active systemic lupus erythematosus who are not being treated by standard of care therapy. This Phase 3 program follows promising results from the Phase 2B clinical trial, of which interim results were presented at ULAR in June of 2019.

With or without systemic manifestations.

59 treatment resulted in a dose response on the classy a score a well defined and reliable outcome measure to detect CRT skin disease activity.

Specifically study participants with Sidoti treated with bid 59 showed statistically significant reductions in classy a score at week 16 versus placebo with a P value on the primary endpoint of less than 0.001.

The 59 was discovered and developed by Biogen scientists and has the potential to be the first at the BDCA two antibody for the treatment of lupus, we plan to initiate a phase three program for bid 59 in the first half of next year.

Geoffrey Christopher Meacham: Together with BIP59 and Deporalizumab, both in late stage development, we are well positioned to potentially build a meaningful franchise in lupus, a disease in which patients need better treatment options. Turning to ophthalmology, we continue to advance our gene therapy programs for inherited retinal disorders, including BIB-111 for choroideremia and BIB-112 for X-linked retinit We expect data from the Phase 3 study of BIM-111 in the first half of next year. Importantly, this represents our next pivotal readout and our next potential commercial product after adjucanumab. We also expect data from the Phase 2-3 study of BIM-112 in the first half of 2021. We are pleased to have entered into a licensing agreement with Massachusetts Eye and Ear Infirmary to develop a potential treatment for inherited retinal degeneration due to mutations in the PRPF31 gene, which are among the most common causes of autosomal dominant retinitis pigmentosa.

In collaboration with our partner you CB, we aim to start in Q3 of this year. The phase three program for Deborah Deborah realism that pega all in patients with active systemic lupus erythematosus, despite being treated by standard of care therapies.

This phase three program follows promising results from the phase Twob clinical trial of which interim results were presented at you are in June of 2019.

Together with 59 and Deborah realism at both in late stage development, we are well positioned to potentially build a meaningful franchise in lupus disease in which patients need better treatment option.

Turning to ophthalmology, we continue to advance our gene therapy programs for inherited retinal disorders, including bid 111 for Korea and bid 112 for X linked retinitis Pigmentosa, both diseases with no approved treatments.

We expect data from the phase three study of bid 111 in the first half of next year. Importantly, this represents our next pivotal readout and our next potential commercial product after edge of Kanuma. We also expect data from the phase two three study of bit 112 in the first half of 2021.

Geoffrey Christopher Meacham: In summary, we continue to progress a broad and deep pipeline focused on neuroscience aimed at capitalizing on breakthrough science, including advancements in imaging, CSF, and blood-based biomarkers and the significant unmet need in this space as we work to create a multi-franchise portfolio. Through the end of next year, we have a significant number of expected mid- to late-stage readouts across a diverse set of important therapeutic areas, including MS, ALS, ophthalmology, Parkinson's disease, stroke, and Alzheimer's disease. We believe that our pipeline will be a source of sustained innovation to help drive long-term growth for the company. I will now pass the call to Geoff.

We're pleased to have entered into a licensing agreement with Massachusetts I in your infirmary to develop a potential treatment for inherited retinal degeneration due to mutations in the PRP F 31 gene which are among the most common causes for autosomal dominant retinitis pigmentosa.

In summary, we continue to progress a broad and deep pipeline focused on neuroscience aimed at capitalizing on the breaking science, including the advancements in imaging CSF and blood based Miami Biomarkers and the significant unmet need unmet need in this space as we work to create a multi franchise portfolio.

Through the end of next year, we have a significant number of expected mid to late stage redoubts across our diverse set of important therapeutic areas, including MMS LS ophthalmology, Parkinson's disease stroke, and also gamers disease, we believe that our pipeline will be a source of sustained innovation to help drive long term growth.

Geoff Meacham: Thanks, Al. Good morning, everyone.

Geoff Meacham: We are pleased that Biogen had another strong quarter despite the COVID-19 challenges as we continue to execute well. We remain in a very strong financial position with significant cash and financial capacity to continue to grow the business over the long term. I will now review our financial performance in the quarter and provide an update to our full year guidance. Total revenues for the second quarter grew 2% year-over-year to $3.7 billion. As a reminder, we believe that the Q1 2020 revenues included a benefit of approximately $100 million attributed to accelerated sales due to the COVID-19 pandemic, of which we believe $75 million was utilized in the second quarter of this year. Overall, we executed well in our MS business.

Both of the company.

Ill now pass the call to Jeff. Thanks.

Good morning, everyone. We're pleased with Biogen had another strong quarter. Despite the cobot 19 challenges as we continued to execute well.

We remain in a very strong financial position with significant cash and financial capacity to continue to grow the business over the long term.

I will now review our financial performance in the quarter and provide an update to our full year guidance.

Total revenues for the second quarter grew 2% year over year to 3.7 billion.

As a reminder, we believed that the Q1 2020 revenues included the benefit of approximately 100 million tribute to accelerated sales due to the cobot 19 pandemic.

Which we believe 75 million approximately was utilized in the second quarter. This year.

Overall, we executed well in RMS business delivering revenues of 2.3 billion in the second quarter, including archivists royalties of 208 million declining 2% versus the prior year.

Global Fms revenues in the second quarter decreased 4% versus the prior year with brokers royalties.

Geoff Meacham: Delivering revenues of $2.3 billion in the second quarter, including Okravis royalties of $208 million, declining 2% versus the prior year. Global MS revenues in the second quarter decreased 4% versus the prior year without Ocravis Rural. Importantly, in the current COVID-19 environment, we believe our MS products are well positioned versus the competition based on treatment guidelines from the MS International Federation.

Importantly in the current cobot 19 environment, we believe our emus products are well positioned versus the competition based on treatment guidelines from the CMS International Federation.

You SMS revenues, excluding or service were approximately flat versus the prior year.

We were very encouraged to see growth in share of new prescriptions improvements to sabri interferons within the quarter. Despite the recent increase in competition.

Outside the U.S. RMS revenues were 615 million it declined 11% versus the prior year due in part to a negative effect to foreign exchange rates of approximately 35 million.

Geoff Meacham: USMS revenues, excluding Ocrevus, were approximately flat versus the prior year. However, we were very encouraged to see growth in share of new prescriptions, improvements to fabric, and interferons within the quarter, despite the recent increase in competition. Outside the U.S., RMS revenues were $615 million, a decline of 11% versus the prior year, due in part to a negative effect of foreign exchange rates of approximately $35 million. In addition, we believe that the first quarter of 2020 MS revenues outside the U.S. included a benefit of approximately $59 million attributed to accelerated sales due to the COVID-19 pandemic, of which we believe approximately $37 million was utilized in Importantly, outside the U.S., we drove strong patient growth of 7% as our leading MS therapies continue to be very well received. Global second quarter payment revenues, including both Tecfider and Boomerity, increased 3% versus the prior year, driven by revenue growth in the U.S. In the U.S., fumarate revenue grew 6% versus the prior year.

In addition, we believe that the first quarter 2020, Emmis revenues outside the U.S included the benefit of approximately 59 million attributed to accelerate sales due to the corporate 19 pandemic of which we believe approximately 37 million was utilized in the second quarter.

Importantly outside the US we drove strong patient growth of 7% as our leading emmis therapies continued to be very well received.

Global second quarter revenues, including both tech bidder and numerically increased 3% versus the prior year driven by revenue growth in the U.S.

In the U.S. funeral revenue grew 6% versus the prior year.

Yes, sure <unk> revenues were impacted by an increase in channel inventory of approximately 15 million in the second quarter 2020, compared to a decrease of approximately 15 million in the second quarter of last year.

Second quarter from any revenue was $9 million and we now have access and reimbursement for the vast majority of commercial lives covered.

Within the U.S., we were pleased to see strong execution with growth in our share of both new and total prescriptions for the humorous versus the prior quarter.

As Michelle mentioned, we're increasing our resource allocation proof room equity and it's important to note that could 19 is impacting overall, new prescription volumes in the us, making new product launches more challenging including for rumored.

Geoff Meacham: REVENUES WERE IMPACTED BY AN INCREASE IN CHANNEL LIMITARY OF APPROXIMATELY $15 MILLION IN THE SECOND QUARTER OF 2020, COMPARED TO A DECREASE OF APPROXIMATELY $15 MILLION IN THE SECOND QUARTER OF LAST YEAR. The second quarter of Umerity revenue was $9 million, and we now have Within the U.S., we were pleased to see strong execution with growth in our share of both new and total prescriptions for the fumarates versus the prior quarter. As Michelle mentioned, we are increasing our resource allocation for Rumerity, and it's important to note that COVID-19 is impacting overall new prescription volumes in the U.S., making new product launches more challenging, including for Rumerity. Outside the U.S., Tecmadera's second quarter 2020 revenues declined by 4%, with demand growth offset by price and unfavorable foreign exchange rates.

Outside the U.S. Tech Proterra second quarter, 2020 revenues declined by 4% with demand growth offset by price and unfavorable foreign exchange rates.

We believe the Q1 2020 tech for their revenues outside the US included the benefit of approximately 28 million attributed to accelerate sales due to covert 19 pandemic.

Which we believe approximately 17 million was utilized in Q2 2020.

Importantly, the number of tech, but there are patients outside the us grew by approximately 12% versus prior year, driven by approximately double digit patient growth across Europe, and approximately 38% patient growth in Latin America, and Asia Pacific combined.

Q2, global interferon revenues, including both Avnet complexity decreased 13% versus Q2 2019 due to continued shift from injectable platforms to oral or high efficacy therapies.

In the U.S. interferon revenues decreased 9% versus prior year.

However, we were pleased to see growth in share of new prescriptions and stable share of total prescriptions in the second quarter, something we have not seen sometime as we have continued to see increased interest in interferons since the corporate 19 pandemic began.

Geoff Meacham: We believe that Q1 2020 taxpayer revenues outside the U.S. included a benefit of approximately $28 million attributed to accelerated sales due to the COVID-19 pandemic, of which we believe approximately 17 million was utilized in Q2 2020. Importantly, the number of tachypodera patients outside the U.S. grew by approximately 12% versus the prior year, driven by approximately double-digit patient growth across Europe and approximately 38% patient growth in Latin America and Asia-Pacific combined.

Outside the U.S interfering revenues decreased by 22% versus the prior year.

We believe that the first quarter 2020 inner front of revenues outside the U.S. included the benefit of approximately 21 million attributed to accelerate sales due to the corporate 19 pandemic.

Which we believe approximately $15 million was utilized in the second quarter. This year.

To summary worldwide revenues decreased by 9% versus the second quarter 2019 in the U.S. to sabry revenues decreased 8% versus prior year, which we estimate is equally impacted by inventory dynamics and the impact of covered 19, given delays in dosing at a fusion sites.

Geoff Meacham: In Q2, Global Interferon revenues, including both Avonex and Plegrity, decreased 13% versus Q2 2019 due to a continued shift from injectable platforms to oral or high-efficacy therapies. In the U.S., interferon revenues decreased 9% versus the prior year. However, we were pleased to see growth in share of new prescriptions and stable share of total prescriptions in the second quarter, something we have not seen in some time as we have continued to see increased interest in interferon since the COVID-19 pandemic began. However, outside the U.S., Interferon revenues decreased by 22% versus the prior year. We believe that the first quarter 2020 Interferon revenues outside the U.S. included a benefit of approximately $21 million attributed to accelerated sales due to the COVID-19 pandemic, of which we believe approximately $15 million was utilized in the second quarter of this year. SABRI worldwide revenues decreased by 9% versus the second quarter of 2019.

Within the U.S., we were pleased to see roughly stable adjusted volumes and share of new prescriptions versus the prior quarter.

Outside the U.S. discovery revenues decreased by 11% versus the prior year negatively impacted by approximately 12 million due to unfavorable foreign exchange rates as well as channel dynamics.

In addition, we believe that Q1 2020 to Sabri revenues outside the US included the benefit of approximately 7 million attributed to accelerate sales due to the cobot 19 pandemic of which we believe approximately 5 million was utilized in the second quarter 2020.

Importantly outside the U.S., we were pleased to see continued patient growth of 5% for salary versus the prior year.

We believe the sorry is well positioned to play an increasingly important role NMS treatment with several important initiatives, including pursuing to Sabri subcutaneous administration, the potential for extended interval dosing and an option for home infusion.

Overall, we were pleased with the execution over Emmis franchise and the continued strong performance of our emmis business in the second quarter.

We remain focused on maximizing the resilience of our market leading franchise.

Let me now move on to Spinraza.

Global second quarter spin Robert revenues increased 1% versus the prior year to 495 million.

In the U.S. revenues decreased 9% versus the second quarter, 2019, and decreased 11% percent versus the first quarter 2020.

The number of patients on during the therapy in the U.S. increased by 6% as compared to the prior year and decreased slightly versus the prior quarter. As we believe cobot 19 had an impact on new patient starts.

Geoff Meacham: In the U.S., SABRI revenues decreased 8% versus the prior year, which we estimate is equally impacted by inventory dynamics and the impact of COVID-19, given delays in dosing at infusion sites. However, within the U.S., we were pleased to see roughly stable, adjusted volumes and share of new prescriptions versus the prior quarter. Outside the U.S., TISABRI revenues decreased by 11% versus the prior year, negatively impacted by approximately $12 million due to unfavorable foreign exchange rates as well as channel dynamics.

Although the U.S. throughout the business was impacted by Cobot 19, the second quarter. We were pleased with our overall execution as we saw more centers come back online.

And most patients continued to receive their therapy, though with some dosing delays.

We saw strong improvement maintenance doses in June and exited the quarter with good momentum.

Outside the U.S. Spinraza revenues increased 10% versus second quarter 2019, demonstrating strong performance. Despite the impact of corporate 19.

Geoff Meacham: In addition, we believe that Q1 2020 salary revenues outside the U.S. included a benefit of approximately $7 million attributed to accelerated sales due to the COVID-19 pandemic, of which we believe approximately $5 million was utilized in the second quarter of 2020. Importantly, outside the U.S., we were pleased to see continued patient growth of 5% versus the prior year. We believe SAABI is well positioned to play an increasingly important role in MS treatment with several important initiatives, including pursuing SAABI subcutaneous administration, the potential for extended interval dosing, and an option for home infusion. Overall, we were pleased with the execution of our MS franchise and the continued strong performance of our MS business in the second quarter. We remain focused on maximizing the resilience of our market-leading franchise. Let me now move on to Spinraz.

Broad growth across all major regions of the world with an increased number of countries contributing as we continue this very successful product launch importantly, we are encouraged that the recently published independent real World data on the uses Kinross in adults has helped us to secure broader reimbursement for older patients in certain European markets.

Overall, we were pleased with spin Ross's performance in the second quarter. Despite the challenges of corporate 19.

Importantly, we now estimate that there are over 60000 patients with SDMA in global markets, and we expect to commercialize significantly higher than our previous estimate of 45000.

We see continued opportunities for growth for this well established product given the efficacy of Spinraza and the strength of our real world evidence coupled with a significant number of untreated patients across many established and emerging markets.

Let me now move onto mobile solutions business, which generated 172 million in this quarter decreasing by 7%, partially due to market dynamics due to cobot 19.

Geoff Meacham: Global second quarter spin revenues increased 1% versus the prior year to $495 million. However, in the US, revenues decreased 9% versus the second quarter of 2019 and decreased 11% versus the first quarter of 2020. A number of patients on therapy in the U.S. increased by 6% as compared to the prior year and decreased slightly versus the prior quarter, as we believe COVID-19 had an impact on new patient initiation. Although the U.S. Mineraza business was impacted by COVID-19 during the second quarter, we were pleased with our overall execution as we saw more centers come back online and most patients continued to receive their therapy, though with some dos We saw strong improvement in maintenance doses in June and exited the quarter with good momentum.

We believe it the first quarter 2020 by summer revenues included a benefit of approximately 15 million attributed to accelerate sales due to cobot 19 pandemic of which we believe approximately 9 million was utilized in Q2 2020.

Q2, bio Similars revenues were also negatively impacted by a relatively higher slowdown in new treatment for immuno oncology patients as a result, corporate 19 impacting both year over year and quarter over quarter comparisons.

We estimate there are now approximately 215000 patients using our browse summers in Europe.

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

Sabi volumes grew 58% versus the prior year and enroll the volumes grew 46% versus the prior year.

Despite our brought some of those business being impacted by covert 19 within the quarter, we have the opportunity to continue to grow both in Europe, as well as potentially within the U.S. and other geographies with our additional assets.

Geoff Meacham: Outside the U.S., Spinraza revenues increased 10% versus the second quarter of 2019, demonstrating strong performance despite the impact of COVID-19. Broad growth across all major regions of the world, with an increased number of countries contributing as we continue this very successful product launch. Importantly, we are encouraged that the recently published independent real-world data on the use of Spinaraz in adults has helped us to secure broader reimbursement for older patients in certain European markets. Overall, we were pleased with Spinraza's performance in the second quarter, despite the challenges of COVID-19. Importantly, we now estimate that there are over 60,000 patients with SMA in global markets, and we expect to commercialize this number to be significantly higher than our previous estimate of 45,000. We see continued opportunities for growth for this well-established product given the efficacy of Spinraza and the strength of our real-world evidence coupled with a significant number of untreated patients across many established and emerging markets.

Total anti Cdtwenty revenues in second quarter decreased by 17% versus the prior year with increased opus royalties offset by decreased revenues from reduction.

Due to covert 19 dynamics and continued erosion from bio similars.

Total other revenues in the second quarter increased 155%.

Yes.

Versus the prior year due primarily to approximately 330 million in revenues related to the license of certain manufacturing related intellectual property to one of our corporate partners, which impacted contract manufacturing revenues.

This was a previously anticipated transaction in 2020.

Let me now turn to gross margins Q2, 2020 gross margin was 89% improvement versus 87% in the prior year due to higher margin contract manufacturing revenue and improved versus the prior quarter.

Q2, GAAP R&D expense was 18% of revenue and non-GAAP was 15% of revenue.

In the second quarter, we recorded a GAAP expense of 208 million and non-GAAP rent expense of 125 million both related to our collaboration with Sangamo therapeutics.

Q2, GAAP and non-GAAP pests, you know were both 15% of revenue.

We still expect best you need to an increase in second half the year as we ramp up or commercial preparations for adimab.

Q2, GAAP other income was 63 million, which included 103 million in unrealized gains on investments principally driven by an increase in the fair value or equity investments in Ioannis pharmaceuticals and Sangamo.

Geoff Meacham: Let me now move on to our biosimilars business, which generated $172 million in this quarter, decreasing by 7% partially due to market dynamics due to COVID-19. We believe that the first quarter 2020 biosimilar revenues included a benefit of approximately $15 million attributed to accelerated sales due to the COVID-19 pandemic, of which we believe approximately $9 million was utilized in Q2 2020. Q2 biosimilars revenues were also negatively impacted by a relatively higher slowdown in new treatment for immunology patients as a result of COVID-19, impacting both the year-over-year and quarter-over-quarter comparisons. We estimate there are now approximately 215,000 patients using our bryosomers in Europe. Benapali remained the number one prescribed embryo biosimilar across the major EU5 markets. Luxabi volumes grew 58% versus the prior year, and Emeraldi volumes grew 46% versus the prior year.

Q2, non-GAAP other expense was 30 million.

In Q2. This year are effective GAAP tax rate was approximately 22% an increase from approximately 14% in the second quarter 2019. This is due to a nonrecurring prior year income tax benefit on a change in our tax profile. Andy current your income tax expense related to a net valuation allowance for the second quarter of 2020.

Our effective non-GAAP tax rate was approximately 19% an increase from approximately 14% in the second quarter 2019, primarily due to the nonrecurring benefit of the prior year change in our tax profile.

We repurchased approximately 9 million shares in the second quarter at an average price of $313.

Total value of approximately 2.8 billion.

As of the ended the second quarter approximately 1.3 billion was remaining under the share repurchase program authorized in December 2019.

Which now brings us toward Dillard diluted earnings per share in the second quarter, We book GAAP EPS of $9.59, an increase of 22% versus prior year and non-GAAP earnings per share of $10.26, a 12% increase versus the prior year.

Geoff Meacham: Despite our biosimilars business being impacted by COVID-19 within the quarter, we have the opportunity to continue to grow both in Europe as well as potentially within the US and other geographies with our additional assets. Total anti-CD20 revenues in the second quarter decreased by 17% versus the prior year, with increased Ocrevus royalties offset by decreased revenues from Rituxan due to COVID-19 dynamics and continued erosion from biosimilars. Total other revenues in the second quarter increased by 155%.

We generated approximately 1.99 1.95 billion a net cash flows from operations in the second quarter.

We ended the quarter with 5.3 billion in cash marketable securities and 7 billion and debt.

Let me now turn to our updated full year guidance for 2020.

Due to the many factors potentially impacting the intellectual property situation for Tech Proterra. Our updated guidance does not include any offers operational impact from potential generic entry this year.

With that assumption in mind, we expect revenues of approximately 13.8 to 14.2 billion.

We anticipate GAAP R&D expense to be approximately 16% to 17% of total revenues, we expect GAAP and non-GAAP expense to be approximately 17.5% to 18% of total revenues.

Geoff Meacham: Excuse me.

Geoff Meacham: Excuse me Unknown Executive, Ami Fadia, Adam Keeney, and Chris Schott, Biogen Inc. Note: This was a previously anticipated transaction in 2020. Let me now turn to Gross Margin. Q2 2020 gross margin was 89%, an improvement versus 87% in the prior year due to higher-margin contract manufacturing revenue, an improvement versus the prior quarter. Q2 GAAP RD expense was 18% of revenue, and non-GAAP was 15% of revenue. In the second quarter, we recorded a GAAP expense of $208 million and non-GAAP-earned expense of $125 million, both related to our collaboration with Sangamo Therapeutics. Q2 GAAP and non-GAAP SG&A were both 15% of revenue. We still expect SG&A to increase in the second half of the year as we ramp up our commercial preparations for Adekanamab.

We anticipate our GAAP tax rate to be approximately 18.5% to 19.5% and our non-GAAP tax rate to be approximately 18% to 19%.

We anticipate full year 2020, GAAP diluted earnings per share results $32 to $34 and non-GAAP diluted earnings earnings per share to be between 34 and $36.

It's important to note that this guidance does not include any impact from potential acquisitions were large business development transactions as both are very hard to predict.

Our guidance assumes a stable share count off the second quarter of 2020, and no change to foreign exchange rates.

Before I conclude I would like to say that I have truly enjoyed working as a CFO biogen I'm proud of what I have been able to contribute and I believe biogen is on stronger position for too long term shareholder value creation with multiple opportunities ahead of it I wish the best of luck to the entire Biogen team moving forward I'll now turn the call back over to Michel for his closing comments. Thank you so much.

[music].

Biogen continued to demonstrate strong execution. This quarter, we again delivered solid financial results made strong progress advancing our strategy of building a monkey franchise portfolio and importantly, one step closer to a potential approval flooded you can you mab as discussed.

Geoff Meacham: Q2 GAAP other income was $63 million, which included $103 million in unrealized gains on investments principally driven by an increase in the fair value of equity investments in Ionis Pharmaceuticals and Sangamo. Q2 non-GAF other expense was $30 million. In Q2 of this year, our effective gap tax rate was approximately 22%, an increase from approximately 14% in the second quarter of 2019. This is due to a non-recurring prior year income tax benefit on a change in our tax profile and a current year income tax expense related to a net valuation allowance.

Therapy to reduce clinical decline in Alzheimer's disease.

I want to hate to rate our commitment to maximizing we've done so shoulders, and bringing innovative therapies to patients now and over the long term. This requires 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 optimal capital.

Structure as well as aim for superior returns from the investments we make.

Finally, our organization Dick's there obviously the recent racial injustice events and the considerable has iniquity that's still exist as highlighted by the club 19 crises.

Geoff Meacham: For the second quarter of 2020, our effective non-gap tax rate was approximately 19%, an increase from approximately 14% in the second quarter of 2019, primarily due to the non-recurring benefit of the prior year change in our tax profile. We repurchased approximately 9 million shares in the second quarter at an average price of $313 for a total value of approximately $2.8 billion. As of the end of the second quarter, approximately $1.3 billion was remaining under the share repurchase program authorized in December 2019.

Now more than ever we have focused on advancing a liberal the purpose as an organization as we aim to pioneer science for the betterment of humanity. This includes doing the right thing for patients our employees the environment and the community all of which we believe contribute to long term sustainable Sheldon.

You.

This also includes accelerating our 14 diversity and inclusion across our organization and our App with Biogen was already taking leading position from hiring to the way, we conduct clinical trials and working to ensure that the most union at reasonable have access to without piece I am proud of what biogen stance for.

Geoff Meacham: Which now brings us to our diluted earnings per share. In the second quarter, we booked GAAP EPS of $9.59, an increase of 22% versus the prior year, and non-GAAP earnings per share of $10.26, a 12% increase versus the prior year. We generated approximately $1.95 billion in net cash flows from operations in the second quarter. We entered the quarter with $5.3 billion in cash and marketable securities and $7 billion in debt

And I believe this approach.

Positions us well to be is sustainable organization over the long term as we remain focused on being the leader in neuro science to address the tremendous societal need empty space.

Again, I would like to thank our employees around the world what dedicated to making a positive impact on patients lives, including ensuring access slow therapies. During these challenging times, we that we will open the call for questions.

As a reminder, we would appreciate it if you can limit yourself to one question as our number of analysts on the call. Thank you.

Geoff Meacham: Let me now turn to our updated full-year guidance for 2020. Due to the many factors potentially impacting the intellectual property situation for Tecmodera, our updated guidance does not include any operational impact from potential generic entry this year. With that assumption in mind, we expect revenues of approximately $13.8 to $14.2 billion. We anticipate GAAP RD expense to be approximately 16 to 17% of total revenues. We expect GAAP and non-GAAP SG&E expense to be approximately 17.5% to 18.5% of total revenues. We anticipate our gap tax rate to be approximately 18.5% to 19.5% and our non-gap tax rate to be approximately 18% to 19%. We anticipate full-year 2020 GAAP diluted earnings per share results of $32 to $34 and non-GAAP diluted earnings per share to be between $34 and $36. It's important to note that this guidance does not include any impact from potential acquisitions or large business development transactions as both are very hard to predict.

If you would like you asking question.

Our then current on your telephone.

Our first question will come from the line of Cory Kasimov with JP Morgan.

Hey, great. Good morning, guys. Thanks for taking the questions. Let me say, Jeff it's been great work.

So my question is the recently announced space. The re systematic leimer study can you elaborate on the rationale the band 24, one over it and you Matt I guess, what about that made it more attractive to initially move into the Saturday lack required penetration into something up thanks a lot.

Corey This is al Sandrock I actually heard every third word of your question. So I'm not sure, but I think you were asking about band to follow on.

In preclinical Alzheimer's disease, and perhaps comparisons to edge of Canyon map, if thats true.

Then I would say that.

Yes.

Band two for one and educating AMAP are very similar antibodies. They both prefer to bind to aggregated forms of a beta.

And they both show robust effect.

On amyloid pet imaging.

And also both.

Have shown a reduction in clinical decline in phase two or phase one phase three trials the.

We have we're very excited that.

That our partners at Ace I are are initiating this clinical study with the Alzheimer's disease clinical trial, because consortium I believe that starting earlier is the best approach for the turns out for all of these neurological diseases.

Geoff Meacham: Our guidance assumes a stable share count in the second quarter of 2020 and no change to foreign exchange rates. Before I conclude, I would like to say that I have truly enjoyed working as a CFO at Biogen. I'm proud of what I have been able to contribute, and I believe Biogen is in a stronger position for long-term shareholder value creation, with multiple opportunities ahead of it. I wish the best of luck to the entire Biogen team moving forward. I'll now turn the call back over to Michel for his closing comments. Thank you so much, Geoff.

And.

And so we look forward to seeing the results of that.

I'm not sure I heard your question, but I hope I answered it so we need to pull the please keep preclinical study with button Ttwenty four one why we focused on the filing flood you can you maybe we should revert to buy come lifecycle management opportunities.

During the entire continuum, I think east for patients and once we have a readout and answer from the FDA on how we move forward.

Our next question comes from the line of can begin with bank of America.

Michelle Bonacos: ...

Michelle Bonacos: Biogen continued to demonstrate strong execution this quarter. We again delivered solid financial results, made strong progress advancing our strategy of building a multi-franchise portfolio, and importantly, are one step closer to a potential approval for aducanumab as the first therapy to reduce clinical decline in Alzheimer's disease. I want to reiterate our commitment to maximizing returns to our shareholders and bringing innovative therapies to patients now and in the long term. This requires 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 on the investments we make.

Hey, guys. Thanks for the question Jeff also on the same great working with you.

Another one on that you can you have another next decision is.

The next step is a decision from FDA, but.

When you look getting age versus emerge and just wondering if you can go into any detail of the the analysis over say the past six to nine months that you guys.

I have done with FDA, whether that could be.

Published or or at a medical conference or anything that you can share with us in terms of what would.

The developments have then over the past.

Pretty much six.

Since the beginning of this year. Thank you.

Suggests it has to make sure I got that just a question you're asking more about the timing.

Over the next few months.

No no just the quality of the analysis and the details of.

Michelle Bonacos: Finally, our organization takes very seriously the recent racial injustice events and the considerable health inequity that still exists, as highlighted by the COVID-19 crisis. Now, more than ever, we are focused on advancing 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, our employees, the environment, and the community, all of which we believe contribute to long-term sustainable shareholder value. It also includes accelerating our efforts in diversity and inclusion across organizations and areas where Biogen was already taking a leading position, from hiring to the way we conduct clinical trials and working to ensure that the most vulnerable have access to our therapies. I am proud of what Biogen stands for, and I believe this approach positions us well to be a sustainable organization over the long term, as we remain focused on being the leader in neuroscience to address the tremendous societal needs in this space. Again, I would like to thank our employees around the world who are dedicated to making a positive impact on patients' lives, including ensuring access to our therapies during these challenging times. With that, we will open the call for questions.

The data analysis fragile.

In support of the of the filing.

Well it im not sure I heard your question, Jeff, but I think.

Look the filing is based on these three studies emerge engage and prime emerge as the first study to show.

And effect not only on the primary endpoint, but all three pre specified secondary endpoints, we believe that data from engage that portions of the data from engage a negative study that portions of it do support the analysis that we did with.

With that emerge.

And then I'll, then also prime which was published.

Shows a even though the clinical endpoints were exploratory endpoints on the highest dose.

There was.

An effect on MMS E as well as CVR some of boxes and again very similar that the lower doses did not show much of an effect so.

Consistent with the findings from engage and emerge you really need to get to the higher dose and I think our data are all consistent with that.

Okay. Thanks out.

Our next question comes in the line.

With Evercore.

Hi, guys. Thanks for taking my question I guess.

If I may focus on tech there'll be meriting for a second Michelle.

You mentioned, you're working on two lifecycle management programs for PLEGRIDY anti Sabri.

Operator: As a reminder, we would appreciate it if you could limit yourself to one question, as there are a number of analysts on the call. Thank you. If you would like to ask a question, please press star then 1 on your telephone keypad. Our first question will come from the line...

But I feel like the most important lifecycle management program. That's been on the market few months, but has been a complete laggard has been humidity and my question is why is that and why is almost every single precedent on lifecycle management.

Capturing well above 25% share an update to 80% I would just love to hear your take on commercial perspective on what happened on the.

Geoffrey Christopher Meacham: Hey, great, good morning guys. Thanks for taking the questions. Let me just say, Geoff, it's been great working with you while you've been at Biogen. So, my question is about the recently announced Phase 3 pre-symptomatic Alzheimer's study. Can you elaborate on the rationale for choosing BAN2401 over aducanumab? I guess, what about that acid?

Yes.

Thank you for the question.

And I shared with the disappointment for the Fulfillments to date on maybe key and you can anticipate that to based on the buttons lives that we have we are working on like second the management opportunities for the for the long run.

Geoffrey Christopher Meacham: Corey, this is Al Sandrock. I actually heard every third word of your question, so I'm not sure, but I think you were asking about BAN2401 in preclinical Alzheimer's disease and perhaps comparisons to aducanumab. If that's true, then I would say that yes, BAN2401 and aducanumab are very similar antibodies. They both prefer to bind to aggregated forms of A-beta, and they both show robust effects on amyloid PET imaging, and they also both have shown a reduction in clinical decline in phase two or phase one and phase three trials. We have, we're very excited that our partners at ACI are initiating this clinical study with the Alzheimer's Disease Clinical Trial Consortium. I believe that starting earlier is the best approach for, as it turns out, all these neurological diseases, and so we look forward to seeing the results of that. I'm not sure I heard your question, but I hope I answered it.

We did launch if you may be in December.

And we had encouraging stopped forms and then Claire Kane and DC impact, it's significant heeded patients a new starts and the switches. So we did not anticipate to when we launch in December that three months down the road that we'd be coffee.

And at that time, you will remember because you asked two times. The question. This was not the switch technology. It was a female rate strategy to enhance the share of the female right and the results I know, it's bad but nothing excuse for the lack of performance to date of May Ricky.

For which the U.S. organization ease or over eight.

So what you chose is that it's difficult it's challenging to launch when they need to shutdown.

Challenging to change in behavior, when you cannot meet the prescriber.

Michelle Bonacos: So we did support the preclinical study with band 24-1 while we focused on the filing for aducanumab. We will revert back on lifecycle management opportunities during the entire continuum of the disease for patients once we have a readout and an answer from the FDA on how we move forward.

Having said that now the.

Focus is to be looking on.

And this is the good time, because we had very good access close to 90% we.

We increased significantly the resource allocation.

This is a next generation FEMA good data.

Females easy fried chicken as you know in terms of JPY 20 IBT E.

It doesn't mean that all the patients on therapy, there could benefit from do maybe because those are less stable to stay on tecfidera, but.

Geoff Meacham: Our next question comes from the line of Geoff Meacham with Bank of America.

Geoff Meacham: Hey guys, thanks for the question. Geoff also wanted to say it's been great working with you.

Significantly enhance focus of the organization on one brands the memory key the new generation FEMA right and the next months should speak.

Geoff Meacham: I don't want to educate him, but I know the next decision is...

Geoffrey Christopher Meacham: When you look at Engage vs. Emerge, I'm just wondering if you can go into any detail of the analysis over, say, the past six to nine months that you guys have done with FDA, whether that could be published or at a medical conference or anything that you can share with us in terms of what the developments have been over the past few

So we don't give up and you should note.

Our next question comes from the line of Marc Goodman with SBB Leerink.

Yes, good morning.

Jeff I was wondering if you could talk about the SGN a guidance looks like it's $300 million less than it was before.

Geoffrey Christopher Meacham: Pretty much six, you know, since the beginning of this year. Thank you.

Geoffrey Christopher Meacham: So Geoff, just to make sure we got the gist of your question, you're asking more about the timing. Over the next few months.

There's been no change in the ramp up.

Your spend commitment for AD due in the second half the year, so where the cuts coming.

Thanks, Mark so.

In this pandemic we've found that.

Geoffrey Christopher Meacham: Unknown Speaker No, no, just the quality of the analysis and the details of the data analysis strategy came up, you know, in support of

Obviously, there is much less travel going on let much less conferences meetings and other discretionary spend and so the vast majority of that.

Geoffrey Christopher Meacham: Well, I'm not sure I heard your question, Geoff, but I think, look, the filing is based on these three studies, eMERGE, ENGAGE, and PRIME. eMERGE is the first study to show an effect not only on the primary endpoint but all three pre-specified secondary endpoints. We believe that data from ENGAGE, that parts of the data from ENGAGE, a negative study, that parts of it do support the analysis that we did with eMERGE. And also, PRIME, which was published, shows even though the clinical endpoints were exploratory endpoints, on the highest dose, there was an effect on MMS-E as well as the CDR sum of boxes. And again, very similar, that the lower doses did not show much of an effect.

Difference in guidance is due to the fact that we have significant savings in the in the second quarter and we anticipate that those savings will continue in the back half of the year.

Our next question comes from the line of Jay Olson with Oppenheimer.

Oh, hi, thanks for taking the question.

Since you submitted the added cat in that.

Modular fashion can you comment on whether the ft began enrolling reviews as modules or if they waited until the entire BLE submission was completed before initiating their review. Thank you.

Well I don't want to comment on FDA is internal processes.

It's true that we did submit modules as they became available to submit.

And so theyve had some modules for some months now.

But.

Whether or not they reviewed them idle.

Geoffrey Christopher Meacham: Okay. Thanks, Al.

And at the internal processes I can't comment on it.

Michelle Bonacos: Our next question comes from the line of Umer Raffat with Evercore. Hi guys, thanks for taking my question. I guess, if I may focus on Tecfidera Vumerity for a second. Michelle, you mentioned you're working on two life cycle management programs for Plegrity and Tysabri, but I feel like the most important life cycle management program that's been on the market for a few months but has been a complete laggard has been Vumerity. And my question is, why is that? And why is almost every single precedent on life cycle management capturing well above a 25% share and up to 80%? I would just love to hear your take on this commercial...

Thanks.

Your next question comes from the line of Michael Yee with Jefferies.

Hi, good morning, Thanks, and congrats on the progress, particularly Alec filing unprecedented.

Maybe out can you just comment on.

Hi, Good question about how you think about priority review on whether or not there is any reason it would not be and whether or not you guys should logically used a voucher and then you made a nice comment about Europe, how you're preparing their to file sharers that actually you've had a discussion with them and you've gotten sort of similar agreements.

Comment there on your thank you so much.

Speakers you may be on mute.

Im not on mute.

Your next question will come from the line of Terence Flynn with Goldman Sachs.

Michelle Bonacos: We did launch Vumerity in December, and we had encouraging start forms, and then COVID came, and this significantly impacted the patient's new starts and the switches, so we did not anticipate when we launched in December that three months down the road, there would be COVID. And at that time, you will remember, because you asked the question a few times, the strategy was not a switch strategy. It was a FUMA rate strategy to enhance the share of the FUMA rate, and the results are not bad.

Okay great.

Thanks for taking the question.

Maybe a two part for me I was just wondering Jeff if you can comment on what drove the change to the revenue guidance anything more specifically and are you assuming spinraza is going to grow in the back half of the year and then it was wondering more broadly maybe question for for Al. If you can confirm that Acuvue was the CRL for that add two phase three trials.

And just wondering how involved the company was in the filing process and if they were party to the discussions with the FDA. Thank you.

Hi, this is out sandrock.

Not sure Michael heard my answer a previously dominant repeated.

On the priority review question, we do have a voucher we received one when we got new centers and approved but we haven't commented on how we're going to use at one we're going to use that we do expect to hear about whether or not we have priority review at the time, the FDA notified us of the acceptance of the filing.

Michelle Bonacos: But this is not an excuse for the lack of performance to date of Umeriti, for which the U.S. organization is all over it. So what it shows is that it's difficult, it's challenging to launch when there is a shutdown. It is challenging to change your behavior when you cannot meet the prescriber.

And.

And so we'll leave it at that in terms of the.

Ex us regulators I think that was the second part of your question.

Michelle Bonacos: Having said that, now the entire focus is pivoting on Vumerity, and this is a good time because we have very good access, close to 90%. We significantly increased the resource allocation. This is a next-generation FIMARATE with good data. Humerity is differentiated, as you know, in terms of GI tolerability. However, it doesn't mean that all the patients on TECFIDERA could benefit from Vumerity because those who are stable should stay on TECFIDERA. But there is a significantly enhanced focus of the organization on one brand, Vumerity, the new generation fumarate, and the next month should speak for itself. So we don't give up, and you should not.

We have engaged formally with the.

He may.

And we were in the process of preparing a filing for the European submission and we have had also informal interactions with the Japanese regulators and we're preparing that filing as well.

So maybe moving too.

Turns his question on kind of what drove the difference in guidance I'd point, you back to the first quarter, where we.

We left guidance the weight was before even in light of the covenant pandemic and with a view that we wanted to see.

Geoff Meacham: Our next question comes from the line of Marc Goodman with SBB Learing. Yes, good morning.

How things played out.

Now as we sit here at the end of July we've got a better sense of what the impact was on the second quarter and there was both the.

Geoff Meacham: Geoff, I was wondering if you could talk about the SG&A guidance. It looks like it's $300 million less than it was before. But there's been no change in the ramp-up in your spend commitment for ADU in the second half of the year. So where are the cuts coming from?

Unwind of the activity in the from the first quarter, which we described plus some headwinds in some businesses still like Spinraza and to sorry, we expect some of those headwinds to continue into the back half of the year. So the vast majority of the difference in guidance is due to kind of continued cobot impact which.

Geoff Meacham: Thanks, Marc. So, you know, in this pandemic, we found that obviously, there's much less travel going on, much less conferences, meetings, and other discretionary spend. And so the vast majority of that difference in guidance is due to the fact that we have significant savings in the second quarter, and we anticipate that those savings will continue in the back half of the year.

It was difficult to predict when we did the guidance, but would also point out that we did see a significant strengthening of the business through the month of the second quarter, particularly if you look at us.

SMB business, where April was a very challenging month and then we saw strengthening in May and then significant strengthening in June so.

Geoffrey Christopher Meacham: Our next question comes from the line of Jay Olson with Oppenheimer.

Other comment would be we went with a fairly wide range, because we're still kind of assessing how quickly comes back so.

Geoffrey Christopher Meacham: Oh, hi, thanks for taking the question. Since you submitted the aducatumab DLA in a modular fashion, can you comment on whether the FDA began a rolling review of those modules or if they waited until the entire BLA submission was completed before initiating the review? Thank you.

Big differences the Kogan impact.

For the full year that pulls guidance down, but we did see a strengthening and and Spinraza, which was encouraging swap to see all with all that plays out.

And then I think there was a question on Q yet.

Yes, I Cubo was the CR road that helped us conduct the phase three trials of education. Umar. However, they were not involved in any of the regulatory interactions that we've had with FDA.

Geoffrey Christopher Meacham: Well, I don't want to comment on FDA's internal processes. It's true that we did submit modules as they became available to submit, and so they've had some modules for some months now. But whether or not they reviewed them, I don't, you know, that's FDA internal process, and I can't comment on it.

Our next question will come from the line of American inherent.

Organ failure.

Great. Good morning, Thanks for taking my question.

Our could you just clarifying the comment you just made around priority review the ultra sound like you're not willing to say whether or not you use it to file for for AD. You and then secondly can you just comment on on anti lingo.

Geoffrey Christopher Meacham: Your next question comes from the line of Michael Yee with Geoff... Hey, good morning, thanks, and congratulations on the progress, particularly Al with the filing. I know that was unprecedented. Maybe, Al, can you just comment on a simple question about how you think about priority review and whether or not there is any reason it would not be, and whether or not you guys logically used a voucher. And then you made a nice comment about Europe, how you're preparing there to file, so is that actually you've had a discussion with them, and you've gotten sort of a similar agreement? Just comment on Europe. Thank you so much. Speakers, you may be on. I'm not on mute.

Well you view as a positive results from that study or what do you need to see to move that in the phase three thanks.

Hi, Matthew yet so.

In terms of the prior debts right we're not.

Well, you could comment on whether or not we've used our our priority voucher.

And in terms of anti Lingo. The primary endpoint is the overall response score, which looks which is a four components score.

Looking at.

Walking EDSS and nine whole peg tests and the dominant arm.

Nine whole pegged Peck tests in the non dominant arms, so four components and we're looking at whether or not patients.

Overall improve because as you know a mass effects different parts of the central nervous system and at times you can have improvement in one area and worsening in another so we wanted to know whether or not overall the patients improve in addition to that of course, we're going to be looking at imaging measures related to myelination. So for example magazine.

Geoffrey Christopher Meacham: Our next question will come from the line of Terence Flynn with Goldman Sachs.

Geoff Meacham: Great. Thanks for taking the question. Maybe a two-parter for me.

Geoffrey Christopher Meacham: I was just wondering, Geoff, if you could comment on what drove the change to the revenue guidance, anything more specifically, and are you assuming Spinraza is going to grow in the back half of the year? And then, more broadly, maybe a question for Al, if you could confirm that Acuvia was the CRO for the ADU Phase III trials. I'm just wondering how involved the company was in the filing process and if they were party to the discussions with the FDA. Thank you.

And transfer ratio MTR is a good measure of myelination and we will be looking at that so in addition to the clinical we'll be looking to see if we have biological measurements that are consistent with myelination.

Your next question comes from the line of Ronny Gal Bernstein.

Hi, Good morning, everybody. Congratulations nice is awesome. Thank you for taking the questions.

You have presented before the submission there I'll have to kind of not there Scott.

Geoffrey Christopher Meacham: Hi, this is Al Sandrock. I'm not sure Michael heard my answer previously, so I'm going to repeat it. On the priority review question, we do have a voucher. We received one when Nusin Ersin was approved, but we haven't commented on how we're going to use it or when we're going to use it. We do expect to hear about whether or not we have priority review. At that time, the FDA will notify us of the acceptance of the filing, and so we'll leave it at that. In terms of the ex-U.S. regulators, I think that was the second part of your question. We have engaged formally with the EMA, and we're in the process of preparing a filing for the European submission. And we have also had informal interactions with the Japanese regulators, and we're preparing that filing as well.

The patients and discussions about.

You've done the same and even more than that with the FDA.

I was wondering if you can share with us what is the primary facing caught used to their reviews that total sensation and all those to receive.

Number of high doses versus placebo and duty segment can answer that.

Let me if you can share anything that.

You are using cocaine rebate differences to drive the adoption of marriage going forward or just the difference in DJ Basin will focus off the organization.

So Ron I'll take the first part.

So we submitted all the data from those three studies that I mentioned emerge engage and prime and what the FDA chooses to look at is.

That's their per view.

We I will say that in terms of the negative study engage we do we have.

Geoffrey Christopher Meacham: So maybe moving to Terence's question on kind of what drove the difference in guidance, I'd point you back to the first quarter, where we left guidance the way it was before, even in light of the COVID pandemic, with the view that we wanted to see how things played out. Now, as we sit here at the end of July, we've got a better sense of what the impact was on the second quarter. And that was both the unwind of the activity from the first quarter, which we described, plus some headwinds in some businesses still like Spinraza and Disabri. And then we saw strengthening in May and then significant strengthening in June. So another comment would be we went with a fairly wide range because we're still kind of assessing how quickly it comes back. So the big difference is the COVID impact for the full year that pulls the guidance down. But we did see a strengthening of Spinraza, which was encouraging. So we'll have to see how all that plays out.

Analyses as show that those who received the highest dose over a sustained period of time do show evidence of efficacy similar to what we found in emerge.

And so that's the data we presented to see Ted and at the PD and Thats why we believe they're supportive evidence coming from engage.

So concerning the second part of the question or any on who May Ricky.

Since the focus now he is on the memory T not on the FEMA rates I can tell you that all levers outline.

At the figure level at the patient services level at the sales force levels, including incentive schemes to shape the behavior at the media kind of fast level. So the.

Question is absolutely aligned and focused on all those levels.

Excitements will be critical.

Thank you.

Your next question comes from the line of Phil Nadeau with Cowen and company.

Geoff Meacham: And then I think there was a question about IQVIA. Yes, IQVIA was the CRO that helped us conduct the phase three trials of aducanumab. However, they were not involved in any of the regulatory interactions that we've had with FDA.

Good morning, Thanks for taking my question, Jeff, Let me add my well wishes as you move onto next opportunity. Thanks for the help over the years.

Question for you out in the prepared remarks, you suggested that the FDA and the Prebuilding meeting noted that the submission of added can map based on the three studies is reasonable I'm curious whether you can provide any more detail on the prevailing meeting what topics were discussed what feedback did you receive and maybe in particular to the FDA indicate whether an advisory committee would be likely.

Geoffrey Christopher Meacham: Our next question will come from the line of Matthew Harrison with Morgan Stanley.

Geoffrey Christopher Meacham: Great, good morning. Thanks for taking the time to answer the question. One, Al, could you just clarify the comment you just made about the priority review voucher? It sounds like you're not willing to say whether or not you used it to file for ADJU. And then secondly, can you just comment on anti-lingo? What would you view as a positive result from that study, or what do you need to see to move that into phase three? Thanks.

Thanks.

Hi, Phil yet so it's our policy not to talk about the content of our regulatory interactions. So I'm not I'm I'm not prepared to go any further than what I said in my prepared remarks.

In terms of the Advisory committee it would not be unusual for the first disease modifying therapy of this type to be.

Geoffrey Christopher Meacham: Hi Matthew, yeah, so in terms of the prior, that's right, we're not willing to comment on whether or not we've used our priority voucher. And in terms of anti-lingo, the primary end point is the overall response score, which is a four-component score, looking at walking EDSS and the nine-hole PEG test in the dominant arm and nine-hole PEG test in the non-dominant arm, so And we're looking at whether or not patients overall improve, because as you know, MS affects different parts of the central nervous system, and at times you can have improvement in one area and worsening in another. So we wanted to know whether or not overall patients improved. In addition to that, of course, we're going to be looking at imaging measures related to myelination. So, for example, magnetization transfer ratio, MTR, is a good measure of myelination, and we'll be looking at that. So in addition to the clinical, we'll be looking to see if we have biological measurements that are consistent with myelination.

Reviewed at an advisory committee. So we are starting to prepare for one or whether or not we have one and when it will be will be up to the FDA and we expect to hear that at around the time that we notified of whether or not the files been accepted.

Great. Thank you.

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

Thank you.

I've a question on AD Academy.

Towel as a biomarker, which channels timers is really risen prominence over the last few years. These are measured as pets or.

Yes out.

The amount of cow biomarker data you collected.

And engage in a merger is quite low.

The context of the size of those two trials and I'm wondering what FDA feedback has been.

On this in terms of potentially wanting more cow biomarker data my understanding is that the new embark study.

You are capturing how on everyone I think that includes tally imaging.

So any commentary on that would be helpful. Then.

Guys have been willing to disclose you've asked for prior to review.

Haven't heard you talked about as whether you've or court requested breakthrough therapy designation, which has arguably a better litmus test for.

Views.

Thank you.

So Tim you're right that how has risen in prominence as an important biomarker and perhaps drug target in Alzheimer's disease, and that's because if you look at what correlates best with clinical progression tile accumulation seems to do so however, our and our belief is that there's an IND.

Geoffrey Christopher Meacham: Your next question comes from the line between Ronnie Gao and Bernstein.

Geoffrey Christopher Meacham: Good morning everybody. Congratulations on the nice result and thank you for taking the question. You have presented various alpha-glucanomab, and various cuts of the patient, before the submission.

Our action between amyloid beta and towel and it's possible that how could be triggered tao miss folding and spreading could be triggered by a number of factors trauma for one but it could be that amyloid beta also does and our data with would be consistent with that in the sense that when we lowered we use that you can measure.

Geoffrey Christopher Meacham: Discuss them with us at

Geoffrey Christopher Meacham: I was wondering if you could share with us what the primary patient cut used for the review? Is it the total set of patients, all those who received a certain number of high doses versus placebo? And do they think you can answer that? I was wondering if you could share with me instead if you're using copay and rebate differences to drive the adoption of Umerity going forward, or is it just a difference in the educational focus of the organization?

Two specific for amyloid beta and we see downstream effects on towel.

Both by imaging and by CSF and the reason why it's not that many patients is that for small it's hard to convince patients to undergo lumbar puncture pump puncture twice.

Or and also.

We're introducing a new tile pet imaging lie again, and we're already imaging patients with four amyloid so.

Geoffrey Christopher Meacham: So, Ronnie, I'll take the first part. So we submitted all the data from those three studies that I mentioned, eMERGE, ENGAGE, and PRIME. And what the FDA chooses to look at is, you know, that's their purview. I will say that in terms of the negative study, ENGAGE,

Having to do to pet scans to different types of pet scans is a lot to us for patients, but we do think we have adequate data to show a convincing effect on tile not only in the CSF, but also by imaging.

And I now have now forgotten the second part of your quite true on the Braille breakthrough yeah. What we do have fast track status and we expect to hear about a priority review and you know with the fast track status, we have the opportunity to engage with FDA and I'll say that we've we very much appreciate the.

Geoffrey Christopher Meacham: We have analyses that show that those who receive the highest dose over a sustained period of time do show evidence of efficacy similar to what we found in eMERGE. And so that's the data we presented to CTAD and ADPD, and that's why we believe there's supportive evidence coming from Engage.

A level engagement we've had.

Essentially since last June where we've had a number of constructive collaborative interactions with FDA.

Michelle Bonacos: So concerning the second part of the question on vumerity, since the focus now is on vumerity, not on the fumarates, I can tell you that all levels are aligned, at the payer level, at the patient services level, at the sales force level, including incentive schemes to shape behavior, at the medical affairs level. So the organization is absolutely aligned and focused on all those levels. The next five months will be critical. Thank you.

Thank you.

Your next question comes from the line, Brian Abrams with RBC capital markets.

Hi, there. Thanks, so much for taking my question question on Spinraza, an estimate dynamics.

What were you guys be looking for out of the new study in combination with gene therapy.

Is there any sort of bar from reimbursement perspective that one might expect for combo use and it can you comment on any additional commercial perhaps or.

Evolution in strategy had a potential entry of an oral sex.

Well the the reason for doing I'll take the first part Brian The reason for doing this study our AR is mainly because a clinicians are already doing it but theres no data from the study on whether or not it's helpful to patients in fact, the European journal of pediatric neurologist.

Michelle Bonacos: Your next question comes from the line of Phil Nadeau with Cowan & Company. Good morning.

Geoff Meacham: Thanks for taking my question. Geoff, let me add my well wishes as you move on to your next opportunity. Thanks for the help over the years.

Just published a consensus statement of European experts in SDMA and they point out that there's.

Geoffrey Christopher Meacham: Question for you, Al. In your prepared remarks, you suggested that the FDA at the pre-BLA meeting noted that the submission of adekinema based on the three studies is reasonable. I'm curious whether you can provide any more detail on the pre-BLA meeting. What topics were discussed? What feedback did you receive? And maybe, in particular, did the FDA indicate whether an advisory committee would be likely? Thanks.

Real lack of data on the use of this combination therapy and they called for more more studies on it and so we're happy to be doing one and the key question is do you see improvement beyond what you see with just one therapy alone when you add spinraza to Xeljanz, my or Xeljanz amount to spinraza.

And so it's really looking at.

Motor milestones, whether you maintain them better whether you gained more more more motor milestone that so it's really more mostly about efficacy.

And I think that it's very good tools to help clinicians.

Geoffrey Christopher Meacham: Hi Phil. Yeah, so, it's our policy not to talk about the content of our regulatory interactions, so I'm not, I'm not prepared to go any further than what I said in my prepared remarks. In terms of the advisory committee, it would not be unusual for the first disease-modifying therapy of this type to be reviewed by an advisory committee, so we are starting to prepare for one. Whether or not we have one and when it will be will be up to the FDA, and we expect to hear that at around the time that we are notified of whether or not the file has been accepted.

Prioritize.

Which topic option to use based on research and not based on speculation or claims you.

You should look at the competitive landscape for Riki plan.

It's too hard to speculate because if you ignore label yet.

Hi, a fish was pretty consistent essentially each was underwhelming in terms of achieving the objectives.

When I speak to send TV quito's their positions into late just wait for the long term safety and efficacy profile of the product.

And for the gene therapy, I think we have the profile that stuff's would be well characterized and the issue if I refer back to the latest consensus fibrillation dealer pendulum that have begun technology, maybe Keith uncertainty for the older population behavior, the incense ease and they see it.

Geoffrey Christopher Meacham: Great, thank you. Your next question comes from the line of Tim Anderson with Wolf Research. Thank you.

Geoffrey Christopher Meacham: I have a question on adecanumab. On tau as a biomarker, which in Alzheimer's has really risen to prominence over the last few years, either measured as PET or in serum or CSF, the amount of tau biomarker data you collected in Engage and Emerge was quite low in the context of the size of those two trials. And I'm wondering what FDA's feedback has been to you on this. In terms of potentially wanting more Tau biomarker data, my understanding is that in the new Embark study, you are capturing Tau on everyone. I think that includes Tau imaging, so any commentary on that would be helpful. And then, you guys have been willing to disclose that you've asked for a prior review. What I haven't heard you talk about is whether you've requested breakthrough therapy designation, which is arguably a better litmus test for how FDA views the data you have.

I think we the potential risk to the to the weight. So the center quito's busy key anchor H at looking at all the options.

For full Biogen and we we are we stand behind efficacy and safety of Spinraza in all age groups and we have allowed your body of evidence the product is a proven selling 50 countries.

So we believe that Spinraza, we continue to be really is very good treatment and has done a TV in this context, where they have eased a bit more.

Treatment in these markets, which is good for the patients.

Geoffrey Christopher Meacham: So, Tim, you're right that Tau has risen in prominence as an important biomarker and perhaps drug target in Alzheimer's disease. And that's because if you look at what correlates best with clinical progression, Tau accumulation seems to do so. However, our belief is that there's an interaction between amyloid beta and Tau, and it's possible that Tau could be triggered. Tau misfolding and spreading could be triggered by a number of factors, trauma for one, but it could be that amyloid beta also does. And our data would be consistent with that in the sense that when we lowered the dose, we used aducanumab, which is specific for amyloid beta, and we see downstream effects on Tau, both by imaging and by CSF. And the reason why it's not that many patients is that, first of all, it's hard to convince patients to undergo lumbar puncture twice, and also we were introducing a new TAO PET imaging ligand, and we're already imaging patients with amyloids, so having to do two PET scans, two different types of PET scans is a lot to ask patients, but we do think we have adequate data to show a And I've now forgotten the second part of your question.

So we are working to enhance efficacy by increasing the dose I'm not sure. This can do that.

And last but not least Davies. The response study after gene therapy. So I think it's good to best educate the market. So we are confident.

Thanks to solid thanks.

Five time about two more questions.

Your next question will come from the line at FMC come in with Credit Suisse.

Hi, all thank you very much for taking my question. Thanks, Congrats on the progress. So in the press released last night from Mikes appointment was clear that you emphasized his expertise in quotes value, creating strategic financial considerations should we read this as an evolution to more or larger transformative business development is under Jess leadership, there was only really.

One major deal, which was a nice star acquisition.

Well together, we Jay if we Oh, we delivered on 18 deals and.

Remember, we believe we have the and inequality in in this space, where we are specialized so the sweet spot to ease early stage disease, where we can at most of value.

And I am delighted to see this portfolio maturing extremely well.

That's very important readouts in the coming 12 months' and beyond that.

Kit Twentytwenty full 2025 and between now and these 22 epic Ttwenty four or five Davies one to be coal, which is I'd you came up.

Geoffrey Christopher Meacham: Breakthrough. Oh, breakthrough. Yeah, well, we do have fast-track status, and we expect to hear about a priority review. And you know, with fast-track status, we have the opportunity to engage with FDA, and I'll say that we very much appreciate the level of engagement we've had essentially since last June, when we had a number of constructive, collaborative interactions with FDA.

So I.

I can tell you that we continue to be they'll be at keys on the on the BD M&A front, but at the same time, we have they weekend, where do we approach as you can you might potentially and we always investing the interest of the long term shareholder value creation.

Great. Thank you.

Geoffrey Christopher Meacham: Your next question comes from the line of Brian Abrahams with RBC Capital Market. Hi there, thanks so much for taking my question. A question on Spinraza and SMA dynamics.

Our final question will come from the line of Robyn Karnauskas with Suntrust Robinson Humphrey.

Great. Thanks for taking my question and thanks for that.

That.

Geoffrey Christopher Meacham: What will you guys be looking for out of the new study in combination with gene therapy? Is there any sort of bar from a reimbursement perspective that one might expect for combo use? And then can you comment on any additional commercial prep or evolution in strategy ahead of potential entry of an oral? Thanks.

Well I want to ask about the phase three star trial for core core or do you mean dairy me up.

Before I walk us or what the bar is and then what would be the best case scenario.

The best reimbursement for the drug and then what would be the next up yet be able to treat on even younger patients with a disease as many people got that when they're very very young. Thank you.

Michelle Bonacos: Well, the reason for doing the study is mainly because A, clinicians are already doing it, but there's no data from the study on whether or not it's helpful to patients. In fact, the European Journal of Pediatric Neurologists just published a consensus statement of European experts in SMA, and they point out that there's a real lack of data on the use of this combination therapy, and they called for more studies on it, and so we're happy to be doing one. And the key question is, do you see improvement beyond what you see with just one therapy alone when you add Spinraza to Zolgensma or Zol And so it's really looking at motor milestones, whether you maintain them better, whether you gain more motor milestones. So it's really mostly about efficacy.

Hi, Rob and this is out yes. So the bid on 11, which is our gene therapy for quarter EMEA.

The phase three trial is about 160 patients and the and the primary endpoint or the bar as you point out is the proportion of patients who have a greater than 15 letter increase from baseline in the best corrected visual acuity. That's the FDA standard it's a it's a two arm trial placebo.

And so we just need to.

Have a better improvement in visual acuity in the treated patients versus the non treated patients. This trial was initiated in December of 2017, we announced our last patient in November of 2019, and so we do expect to readout in first quarter of next year.

Michelle Bonacos: And I think that it's very good to help clinicians prioritize, you know, which therapeutic option to use based on research and not based on speculation or claims. If you look at the competitive landscape for RISD plans, it's still hard to speculate because there is no label yet. Firefish was pretty consistent, but Sunfish was underwhelming in terms of achieving the objectives.

And and and the phase three trial is on the heels of a phase one trial, which.

It was a single arm study in a compared the proportion of patients who had an improvement in best corrected visual acuity relative to a natural history study and the drug did show some very encouraging results on on that endpoint. So we're just basically using the same endpoint.

Michelle Bonacos: When I speak to scientific leaders, their position is that we need to wait for the long-term safety and efficacy profile of the product. And for gene therapy, I think we have a profile that is starting to be well characterized. And if I refer back to the latest consensus published in the European Journal of Pediatric Neurology, there is still uncertainty for the older population. Behavior, the infant, and they see a link with the potential risk for weight.

For phase three and trying to hit the standard set by the FDA.

Thank you I'd like to handed over to Michelle and just for some closing comments. Please. Thank you so much Joe and thank you for attending I want to thank Jeff again for his many contribution.

To our company.

Biogen, it's all about by unique Irene in Neuro science.

Michelle Bonacos: So the scientific leaders basically encourage looking at other options. For Biogen, we stand behind the efficacy and safety of Spinraza in all age groups, and we have a larger body of evidence. The product is now approved in 50 countries, so we believe that Spinraza will continue to be really a very good treatment and alternative in this context, where there is a bit more treatment on this market, which is good for the patient. So we are working to enhance the efficacy by increasing the dose. But I'm not sure others can do that. And last but not least, there is a response study after gene therapy, so I think it's good in order to best educate the market.

So we are approaching a very exciting face off our full to use plus of development.

Pipeline and all the many allocation of capital in that space East maturing, we have very important readout seem to coming 10 months, we have seven phase three and we have very close to open a new page. If you allows we'd add you KEDNY mob. Thank you old for your attention.

Ladies and gentlemen that will conclude today's call. Thank you all for joining and you may now sort our comp.

[music].

Michelle Bonacos: Thanks, Michelle, and Al. I have time for about two more questions. Your next question will come from the line of Evan Seigerman with Credit Suisse.

Michelle Bonacos: Hi all, thank you very much for taking my question, and congratulations on the progress. So, in the press release last night from Mike's appointment, it was clear that you emphasized his expertise in, quote, value-creating strategic financial considerations. Should we read this as an evolution to more or larger transformative business development? As under Jeff's leadership, there was only really one major deal, which was the Nightstar acquisition?

Michelle Bonacos: Well, together with Geoff, we delivered on 18 deals. And remember, we believe we have an unfair advantage in the space where we are specialized. So the sweet spot is the early stage. This is where we can add the most value. And I am delighted to see this portfolio maturing extremely well, 2024-2025. And in between now and this 2024-2025, there is one big hope, which is Adjukanimab. So, I can tell you that we continue to be very active on the BD, and M&A front, but at the same time, we are very careful while we approach, you know, AgiCanumab, potentially. And we will always invest in the interest of long-term shareholder value creation.

Michelle Bonacos: Great, thank you.

Michelle Bonacos: Our final question will come from the line of Robyn Karnauskas with SunTrust Robinson Humphrey. Great, thanks for taking my question, and thanks, Evan, for the segue. So I wanted to ask about the Phase III STAAR trial for choroideremia. You've got data coming up; you'll be first. Walk us through what the bar is, and then, you know, what would be the best-case scenario to secure the best reimbursement for the drug, and then what would be the next steps to be able to treat even younger patients with the disease, as many people get it when they're very, very young. Thank you.

Geoffrey Christopher Meacham: Hi Robyn, this is Al. Yeah, so the BIBLON11, which is our gene therapy for choroideremia, the phase 3 trial is about 160 patients, and the primary endpoint, or the bar, as you point out, is the proportion of patients who have a greater than 15 letter increase from baseline in the best corrected visual acuity. That's the FDA standard. It's a two-arm trial placebo, and so we just need to have a better improvement in visual acuity in the treated patients versus the non-treated patients. This trial was initiated in December of 2017. We announced our last patient in in November of 2019, and so we do expect to read out in the first quarter of next year. And the phase three trial is on the heels of a phase one trial, which was a single-arm study, and it compared the proportion of patients who had an improvement in best corrected visual acuity relative to a natural history study, and the drug did show some very encouraging results on that end point. So we're basically using the same end point for phase three and trying to hit the standard set by the FDA.

[music].

Michelle Bonacos: Thank you. I'd like to hand it over to Michelle for some closing comments, please.

Michelle Bonacos: Thank you so much, Joe, and thank you for attending. I want to thank Geoff again for his many contributions to our company.

Michelle Bonacos: At Biogen, it's all about pioneering in neuroscience. So we are approaching a very exciting phase of our 40 years plus of development. Our pipeline and all the many allocations of capital in that space are maturing. We have very important readouts in the coming 10 months. We have seven phase three, and we are very close to opening a new page, if it allows, with AgiCanimab. Thank you all for your attention.

Operator: Ladies and gentlemen, that will conclude today's call. Thank you all for joining, and you may now disconnect.

Operator: ??? ??? ??? ??? ??? ??? © BF-WATCH TV 2021