Q1 2022 Biogen Inc Earnings Call

Cecilia: Good morning. My name is Cecilia, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen first quarter 2022 earnings call and business update. All lines have been placed on mute to prevent any background noise.

Good morning, My name is Cecilia and I will be your conference operator today at this time I would like to welcome everyone to the Biogen first quarter 2022 earnings call and business update.

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

All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. If you would like to ask a question. During this time simply press star one on your telephone keypad. Please limit yourself to one question to allow other participants time for questions. If you require any further follow up.

You May press star, one again to rejoin the queue.

Cecilia: If you 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. Mike Henke, Head of Investor Relations. Mr. Henke, you may begin your presentation. Thank you.

Thank you I would now like to turn the conference over to Mr. Mike <unk> head of Investor Relations. Mr. Hancock, you may begin your conference.

Mike Henke: Good morning, and welcome to Biogen's first quarter 2022 earnings call. Before we begin, I encourage everyone to go to the investor section of biogen.com to find the earnings release and related financial tables, including our GAAP financial measures and a reconciliation of the GAAP to non-GAAP financial measures that we will discuss today. Our GAAP financials are provided in tables one and two, and table four includes a reconciliation of our GAAP to non-GAAP financial results.

Thank you good morning, and welcome to Biogen's first quarter 2022 earnings call before we begin I encourage everyone to go to the investors section of Biogen Dot com to find the earnings release and related financial tables, including our GAAP financial measures and a reconciliation of the GAAP to non-GAAP financial measures that we'll discuss today.

They are.

Our GAAP financials are provided in tables, one and two and table. Four includes a reconciliation of our GAAP to non-GAAP financial results. We believe non-GAAP financial results better represent the ongoing economics of our business and reflect how we manage the business internally.

Mike Henke: We believe non-GAAP financial results better represent the ongoing economics of our business and reflect how we manage the business internally. We have also posted slides on our website that follow the discussions related to this call. I would like to point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially.

We have also posted slides on our website that follow the discussions related to this call.

I'd like to point out that we will be making forward looking statements, which are based on our current expectations 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 detail.

Mike Henke: 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 Bunatsos, Dr. Priya Singhal, Interim Head of Research and Development, and our CFO, Mike McDonnell. As a reminder, during the Q&A portion of the call, we kindly ask that you limit yourself to one question. I will now turn the call over to Michel. Thank you, Mike.

On today's call I am joined by our Chief Executive Officer, Michel <unk> Soc, Dr. Preet Cingal interim head of research and development and our CFO , Mike Mcdonnell as a reminder, during the Q&A portion of the call. We kindly ask that you limit yourself to one question I will now turn the call over to Michelle. Thank you Mike.

Michelle Bunatsos: Good morning, everyone, and thank you for joining us. We continue to execute on our core business objectives in the first quarter. Mike and Priya will review our quarterly performance and recent progress in R&D, while I focus on our strategy and near-term operational priorities. Let me start with a few comments on the recent national coverage examination by CMS for amyloid beta-targeted therapies for Alzheimer's. This decision effectively denies all Medicare beneficiaries' access to the adjouh helm.

Morning, everyone and thank you for joining US we continued to execute on our core business objectives in the first quarter, Mike and pre I will review, our quarterly performance and recent progress in R&D, while I focus on our strategy and near term operational priorities.

Let me start with a few comments on the recent national coverage determination by CMS for targeted.

Targeted therapies for Alzheimer's disease.

Michelle Bunatsos: We are very disappointed by the final NCD and other results. We will substantially eliminate our commercial infrastructure for adjouh helm. We will retain minimal resources to manage patients, and access programs, including a continued free drug program for patients currently on treatment in the US. We expect to continue funding certain regulatory and R&D activities while you lead, including the continuation of our EMBARQ Redosing Study and the initiation of our Phase IV Post-Marketing Requirements Study and Vision.

This decision effectively denies all Medicare beneficiaries access to add you had them. We are very disappointed by the final N C D and as a result, we will substantially eliminate our commercial in touch with you why do you have them.

We will retain minimal resources to manage patient access programs, including a continued free drug program for patients currently on treatment in the U S.

We expect to continue funding, so I kind of figured that Tory and R&D activities, including the continuation of our embark re dosing study and the initiation of a phase four post marketing requirement study envisions.

Michelle Bunatsos: Additional actions regarding Agile may be informed by upcoming data readouts expected for this class of antibodies as well as further engagement with the FDA and CMS. In parallel, we are committed to working closely with ESSAI on the potential launch of L'Ecadema. We are now looking forward as we work to advance our broader pipeline, including L'Ecadema Benzuranolon, execute on our base business, and deploy our capital in the best interest of We recognize that Biogen is facing a number of near-term challenges, including generic erosion in the feed era, competition for spinraza and biosimilars and DTNFs, and a declining profit share from Rituxan in the U.S.

Additional actions regarding maybe informed by our upcoming data Readouts expected for this class of fancy bodies as well as further engagement with the FDA and CMS.

In parallel we are committed to working closely with the ESI on the potential launch of the cut them up.

We're not looking forwards as we work to advance our broader pipeline, including like Alibaba and Joanna alone execute on our base business and deploy our capital in the best interest of shareholders.

We recognize that Biogen is facing a number of near term challenges. These.

These challenges, including generic erosion of etc.

Competition for skin rosin, but youll see me loss anti TNF.

In a declining profit share from Citrix on in the U S.

Michelle Bunatsos: These challenges are all part of the biopharmaceutical business life cycle, and we believe that potential new product launches such as Lecademab, Zuranolone, and additional biosimilars can help return the company to growth over time. In addition, we see the potential for additional growth drivers in the mid-to-late, and mid-to-late 2020s in other areas, such as stroke, lupus, and Parkinson's disease. And, of course, we will be pursuing new business development opportunities as well. However, given that we are in a long product cycle business and in light of the CMS decision, we recognize there is more we must do today to provide better clarity and visibility into the company's future.

These challenges are all parts of the biopharmaceutical business lifecycle and.

And we believe that potential new product launches such as liquor demob as Johan alone and Additionally by Youll see me loss can help return the company to grow overtime.

Further we.

We see the potential for additional growth driver in the mid to late 'twenty to the mid to late 2000 Twenty's in order already has such.

Such as stroke, lupus and Parkinson's disease and of course, we will be pursuing new business development opportunities as well.

However, given that we are in a long product cycle business and in light of the CMS decision. We recognize there is more we must do to date to provide better clarity and visibility into the company's future.

Michelle Bunatsos: Let me share the priority actions we are implementing now. We are increasing our focus on R&D prioritization with the goal of maximizing the probability of success, which Priya will further discuss. This prioritization process will be informed in part by key data readouts expected in 2020.

Let me share the priority actions, we are implementing now.

First we are increasing our focus on R&D prioritization with a goal of maximizing the probability of success, which <unk> will further discuss.

<unk> process, we've been formed in topped by key data Readouts expected in 2022.

Michelle Bunatsos: In Alzheimer's disease, together with SI, we plan to complete the rolling submission for the canemap under the accelerated approval pathway in the US during the second quarter of this year. In addition, we expect a readout of the phase three Clarity-AD perfumatory trial for L'Ecadema this fall. Based on the results of the study, we plan to submit for full FDA approval by the first quarter of 2023, with the opportunity for Leucanemab to become the first anti-amyloid antibody to obtain full approval for Alzheimer's disease in the U.S. In Neuropsychiatry, we are working with SAGE to advance uranolone as an important new potential option for NDD and PPD.

In the <unk> together with <unk>, we plan to complete the rolling submission for <unk> under the accelerated approval pathway in the U S.

During the second quarter of this year. In addition, we expect readout of the phase III clarity HD prohibits a retrial Felicia this for.

Based on the results of this study we plan to submit for FDA approval by the first quarter of 2023 with the opportunity for <unk> to become the first anti amyloid antibody to obtain full approval for Alzheimers disease in the U S.

In Neurosurgery Secretary, we are working with Sage to advance <unk> hundred one as an important new potential option for MTBE and PPD.

Michelle Bunatsos: We recently initiated the rolling submission of Ranulon in MDD and expect to complete the filing in the second half of 2022. We also look forward to the Phase 3 Skylark study readout in PPD, expected mid this year, with an associated filing for PPD anticipated early next year. Also in Neuropsychiatry, we expect a Phase II readout for BIP-104 in cognitive impairment associated with schizophrenia in mid-2022.

We recently initiated the rolling submission of <unk> hundred learning MTBE and expect to complete the filing in the second half of 2022.

We also look forward to the phase III Skylark study readout in PPD.

Expected mid this year with an associated finding for PPD anticipated early next year.

Also in Neuropsychiatry, we expect the phase II readouts for people and for cognitive impairment associated with schizophrenia in.

In mid 2022.

Michelle Bunatsos: Second, we will implement additional cost reduction and productivity measures above and beyond our previously communicated initiatives to further align our costs with our revenue base. These measures will include the substantial elimination of our commercial infrastructure supporting Aduhelm, as well as all cost reduction activities while we continue to form promising pipelines and commercial opportunities. Third, we are executing on international growth opportunities with a focus on key emerging markets such as China and certain markets in both Latin America and the Middle East.

Second we will implement additional cost reduction and productivity measures above and beyond our previously communicated initiatives to further align our cost with our revenue base.

These measures will include the substantial elimination of our commercial infrastructure supporting that you held as well as all the cost reduction while we continue to fund promising pipeline and commercial opportunities.

Opportunities.

Third we are executing on international growth opportunities with a focus on key emerging markets, such as China and certain markets in both Latin America and the Middle East. This includes the continued launch of spin Liza and then they also include pursuing local business development opportunities.

Michelle Bunatsos: This includes the continued launch of Spinolaza and may also include pursuing local business development opportunities. Fourth, we plan to drive renewed growth in our biosimilar business, although our portfolio of NTT NF products is likely past the peak of its life cycle. We currently have four more programs in development, and in the near term, we are preparing to launch BioViz, referencing Lucentis in the U.S. in the coming months. Our fifth new term priority is capital location.

Fourth we plan to drive renewed growth in our Biosimilars business, although our portfolio of anti TNF products is slightly past the peak of its lifecycle. We currently have four more programs in development and in the near term we are preparing to launch <unk> with for hunting.

<unk> in the U S.

In the coming months.

Our near term priority is capital allocation.

Michelle Bunatsos: Biogen is fortunate to have a strong balance sheet with $4.8 billion cash as of the end of the quarter and modest net debt, as well as strong cash flow generation. Going forward, we plan to continue to focus the deployment of cash towards initiatives designed to create incremental revenue growth opportunities while continuing to return cash to shareholders through share repurchase. In summary, the challenges faced by the company over the past 12 months have been significant. We are committed to taking advantage of all the strengths we have, including our talents.

Biogen is fortunate to have a strong balance sheet with $4 8 billion in cash as of the end of the quarter and modest net debt as well as strong cash flow generation.

Going forward, we plan to continue to focus of deployment of cash towards initiatives designed to create incremental revenue growth opportunities, while continuing to return cash to shareholders through share repurchases.

In summary, the challenges faced by the company over the last the past 12 months have been significant.

We are committed to taking advantage of the strengths, we have including our talent.

Michelle Bunatsos: Our Commercial Portfolio. Our manufacturing capabilities, our pipeline, which includes 10 programs in phase 3 of FILD. And of course, our strong balance sheet to deliver on the performance that is expected from us. Let me conclude by saying that it has been an honor to lead this outstanding company during such a challenging period of time and to work closely with so many dedicated and talented colleagues. I am very proud of all that we have achieved.

Our commercial portfolio our.

Our manufacturing capabilities, our pipeline, which includes 10 programs in phase III of files and of course, our strong balance sheet to deliver on the performance that is expected from us.

Let me conclude by saying that it has been an honor to lead this outstanding company during such a challenging period of.

Of time and to work closely with so many dedicated and talented colleagues I am very proud of all that we have achieved I want to thank the board of directors and my colleagues for their support during this period.

Michelle Bunatsos: I want to thank the Board of Directors and my colleagues for their support during this period. I will be leaving at a time of promise for Biogen, with noteworthy potential for value creation, and I look forward to working with my successor through a smooth transition. I will now turn the call over to Priya for an update on our recent progress in our end group. Thank you, Michelle, and good morning, everyone.

We'll be leaving at the time of promise for Biogen with not towards the potential for value creation and I look forward to working with my successor through a smooth transition.

I'll now turn the call over to <unk> for an update on our recent progress in R&D.

Thank you Michelle and good morning, everyone.

Priya Singhal: As Michelle mentioned, we are enhancing our focus on dynamic R&D prioritization with the goal of ensuring a sustainable pipeline that can deliver on Biogen's vision of a multi-franchise portfolio. We will continue to invest in R&D in a disciplined manner. We will continue to invest in R&D in a disciplined manner, including pursuing new and external opportunities with a potentially different risk-reward profile encompassing those within our core neuroscience therapeutic areas as well as select investments in therapeutic aid cases. This approach will be informed by emerging scientific data, as well as internal and external readouts. As part of our overall prioritization strategy, we may choose to accelerate, terminate, divest, or partner certain programs.

As Michel mentioned.

I'm seeing a focus on dynamic R&D prioritization with a goal of ensuring a sustainable pipeline that can deliver on biogen's vision of a multi franchise portfolio.

We will continue to invest in R&D in a disciplined manner.

Including pursuing new external opportunities with a potentially different risk reward profile and compassion those within our core neuroscience therapeutic area as well as select investments in therapeutic adjacencies.

This approach will be informed by emerging scientific data as well as internal and external readouts.

As part of our overall prioritization strategy, we may choose to accelerate dominate divest our partner certain program.

Priya Singhal: In addition, we will continue to advance key capabilities, such as functional genomics, patient identification, novel modalities, biomarkers, and clinical outcome measures. The goal being to reduce risk, accelerate clinical development, and increase the probability of success in achieving positive proof of concept. I will now share the R&D highlights of the court. Starting with Alzheimer's disease, in addition to continuing the progress with Leucanomab, U.S. filing, and the PACE-PLEA study, ESI presented data at the annual ADPD meeting this past March, showing that leucanomab treatment in the core phase IIb study resulted in a dose and time-dependent reduction of brain amyloid as measured by PET-SUVR, and that the reduction of brain amyloid was correlated with changes in two important peripheral biomarkers of amyloid and tau pathology.

In addition, we will continue to advance key capabilities, such as functional genomics patient identification novel modalities, Biomarkers and clinical outcome measures.

The goal being to reduce risk accelerated clinical development and increase the probability of success in achieving positive proof of concept.

We'll now share the R&D highlights of the quarter.

Uh huh.

Starting with Alzheimer's disease. In addition to continuing the progress with <unk> U S filing in the phase III study <unk>.

<unk> presented data at the annual ADP meeting this past March showing that <unk> treatment in the call phase two B study resulted in a dose and time dependent reduction of brain amyloid as measured by pet SUV are and that the reduction of green I'm annoyed with quarterly.

With changes in two important biomarkers of amyloid and Tau pathology.

Priya Singhal: Specifically, an increase in plasma A-beta 42 to 40 ratio and a decrease in plasma phospho-tau 181 with respect to, Furthermore, these biomarker changes were correlated with clinical benefit, as assessed by the change from baseline in the Clinical Dementia Rating Scale summer box. Notably, however, these peripheral biomarkers gradually began to reverse upon discontinuation of leucanomab treatment at the end of the course study. Suggesting that stopping dosing prematurely may allow the re-accumulation of Alzheimer's disease pathology.

Quickly an increase in plasma E Bay, and a 42% to 40 ratio and a decrease in plasma for swapped out 181, respectively.

Furthermore, these biomarker changes were correlated with clinical benefit.

First by the change from baseline in the clinical dementia rating scale some of boxes.

Notably however, these better fruit biomarkers exactly.

He began to divorce upon discontinuation of the Panama treatment at the end of the cost study.

Suggesting that stopping dosing prematurely may allow the accumulation of Alzheimer's disease pathology.

Priya Singhal: Esai also presented additional information on ARIA from the Leucanomab Phase 2B study, including the incidence of ARIA-E in the open-label extension, where ARIA-E was observed in less than 10% of participants receiving 10 mg per kg licanumab bi-weekly and a symptomatic ARIA rate of less than 2%, consistent with the core study. We look forward to further defining the safety and efficacy of Lecana Mab through the larger Case 3 Clarity AD study.

<unk> also presented additional information on ARIA from the <unk> Phase <unk> study.

This included the incidence of E in the open label extension.

He was observed in less than 10% of participants receiving 10 milligrams per kg Mccann <unk> biweekly any symptomatic ARIA rate of less than 2% consistent with the cost study.

We look forward to further defining the safety and efficacy of the Panama to the larger phase III clarity <unk> study.

Priya Singhal: Biogen and ESAR are currently evaluating subcutaneous dosing in a sub-study of the Clarity AD Open Label Extension, which will evaluate subcutaneous injections compared to IV infusions. This is in addition to the ongoing AHEAD 345 study evaluating licanumab in people with preclinical Alzheimer's disease or prior to cognitive impairment, which was initiated back in 2020. Beyond Lecanumab, Biogen continues to pursue new treatments across molecular targets in Alzheimer's disease. This includes actively planning for the Phase 2 study of BIP-80, our Tau ASO, and initiating dosing in the Phase 1 study of BIP-113.

Biogen and Aesop are.

Currently evaluating subcutaneous dosing in a sub study of the <unk> open label extension, which will evaluate subcutaneous injections compared to IV infusions.

This is in addition to the ongoing ahead 345 study evaluating <unk> in people with preclinical Alzheimer's disease or prior to cognitive impairment, which was initiated back in 2020.

Beyond the cabin Mab Biogen continues to pursue new treatments across molecular targets in Alzheimer's disease.

This includes actively planning for the phase two study of baby <unk> child.

S O and initiation of dosing in the phase one study of Big 113.

Priya Singhal: BIV-113 is a small molecule inhibitor of O-glucanocase or OGA, an enzyme believed to catalyze the removal of O-glucanocase post-translational modification of the tau protein. By inhibiting OGA, we aim to increase the O-glucanylation of tau to potentially inhibit tau aggregation and thereby slow clinical decline.

Big 113 is a small molecule inhibitor of <unk> or <unk>, an enzyme believed to catalyze the removal of <unk>.

Post translational modification of the tile coating.

By inhibiting <unk>, we aim to increase the Auckland emulation of doubt potentially inhibit tau aggregation and thereby slow clinical declines.

Priya Singhal: As Michelle mentioned, with Addy Canumab, we are also continuing to collect data in our Embark Redosing Study and working towards the initiation of AdduHelm Phase 4 Post-Marketing Requirements Study in Vision. Moving to Neuropsychiatry, Biogen and Sage recently announced that we initiated the rolling submission of a new drug application to the FDA for Zoranolone and MDD. We expect to complete the filing in the second half of this year. We are also excited to announce that the Zoranolone Phase III Choral Study in Major Depressive Disorder met the primary endpoint and key secondary endpoint.

As Michel mentioned with added County map. We are also continuing to collect data and box re dosing study and working towards the initiation of agile.

Faithful post marketing requirement study envision.

Moving to neuropsychiatry.

<unk> recently announced that we initiated a rolling submission of a new drug application to the FDA was around alone an M D D.

We expect to complete the filing in the second half of this year.

We were also excited to announce that as of that alone phase three oral study in major depressive disorder met the primary end point and key secondary endpoint.

Priya Singhal: The CORAL study was a randomized, blinded trial designed to assess the rapidity of response when ziranolone 50 mg is co-initiated with an open-label standard of care antidepressant, or ADT, versus placebo co-initiated with ADT, as measured by the change from baseline on the 17-item Hamilton Depression Rating Scale. Top line results showed that Zuranolone co-initiated with ADT resulted in a statistically significant reduction in depressive symptoms at day 3, the primary endpoint, and the earliest time point measured, as well as over the full two-week treatment period as compared to placebo co-initiated with ADT.

<unk> study was a randomized blinded trial designed to assess the apathy of response.

That alone 50 milligrams is core initiated with an open label standard of care antidepressants or ADT versus placebo or initiated with ADT as measured by the change from baseline on the 17 item Hamilton Depression rating scale.

Topline results showed that ran alone for initiated with ADT resulted in a statistically significant reduction in depressive symptoms at day three the primary endpoint and the earliest time point measured as well as over the two week treatment period.

Compared to placebo go initiated with ADT.

Priya Singhal: Durandalone was generally well tolerated, with most treatment-emergent adverse events reported as mild or moderate. In MDD, Zoranolone has now delivered four positive randomized control trials in total, as well as important insights on repeat treatment from the SHORELINE study, a large prospective naturalistic study in MDD. While these trials were designed to address different questions, we see a consistent profile of the ran alone that includes rapid reduction in depressive symptoms compared to the standard of K antidepressants.

Joanne alone was generally well tolerated with most treatment emergent adverse events reported as mild or moderate.

And M D D. Joanne alone has now delivered false positive randomized control trials in total.

As well as important insights on repeat treatment from the shoreline study.

Large prospective naturalistic study in MTBE.

While these trials were designed to address different questions. We see a consistent profile of Duran alone that include.

Rapid reduction in depressive symptoms compared to the standard of care antidepressant at <unk>.

Priya Singhal: A consistent tolerability profile with a low discontinuation rate due to adverse events and without observed weight gain, sexual dysfunction, or suicidal ideation. A short course of treatment that can be potentially taken as needed, and a flexible treatment approach that may provide optionality to HCPs and patients. This is in addition to positive data from the Phase 3 Robyn study of Geranylone in postpartum depression.

Assistant Tolerability profile with a low discontinuation rate due to adverse events and without observed weight gain sexual dysfunction suicidal ideation.

A short course of treatment that can be potentially taken as needed.

And a flexible treatment approach that may provide optionality to hcp's and patients.

This is in addition to positive data from the phase III Robin studies after that alone in postpartum depression.

Priya Singhal: We look forward to the Phase 3 Skylark study readout in PPD expected by mid-year, with an associated filing for PPD anticipated early next year. We look forward to potentially bringing a rapid-onset, well-tolerated oral antidepressant with sustained effects and a new mechanism of action to patients suffering from depression. Moving to ALS, we previously reported that while the Phase 3 VALIS study putting the person in SOD1 ALS, a rare genetic form of ALS, did not achieve the primary endpoint of a statistically significant change on the ALS-FRS-R at week 28 versus placebo, we did observe signs of reduced disease progression across multiple secondary and exploratory endpoints.

We look forward to the phase III Skylark study readout in PPD expected by midyear with an associated filing for PPD anticipated early next year.

We look forward to potentially bringing a rapid onset well tolerated oral antidepressant with sustained effect and a new mechanism of action for patients suffering from depression.

Moving to Alice we previously reported that while the phase III Valor study, but the person in <unk>, a rare genetic form of VNS.

Did not achieve the primary endpoint of a statistically significant change on the ALS FRS or at week 28 versus placebo, we did observe signs of reduced disease progression.

Multiple secondary and exploratory endpoints.

Priya Singhal: We plan to present integrated data from the Phase 3 Ballot Study and a new interim analysis of its ongoing open-label extension at the upcoming NCALS meeting in June. This interim analysis includes data from participants with SOD1 ALS who have had the opportunity for at least one year of follow-up from the start of validation. Long-term data on measures of function, strength, quality of life, and survival will be presented.

We plan to present integrated data from the phase three valor study.

Okay.

The new interim analysis of its ongoing open label extension at the upcoming and counts meeting in June .

This interim analysis includes data from participants with sod one L. S who had the opportunity for at least one year of follow up from the start of Belo.

Long term data on measures of function strength quality of life and survival will be presented.

Priya Singhal: We also continue to recruit for ATLAS, a study evaluating Tufersan in pre-symptomatic participants with a confirmed SORD1 mutation, while also supporting the Global Tufersan Expanded Access Program, which includes approximately 120 people with SORD1 ALS to date from more than a dozen countries. We also remain engaged with regulators on potential next steps for Tupper. As you can see, 2022 is an important year for Biogen R&D, with several important milestones expected as we continue to advance a diversified pipeline that contains a total of 32 clinical programs, with 10 programs in either Phase III or being filed.

We also continue to recruit for Atlas <unk>.

Study evaluating to Hudson in pre symptomatic participants with a confirmed <unk> mutation. While also supporting the global <unk> expanded access program, which includes approximately 120 people with <unk> to date.

For more than a dozen countries.

We also remain engaged with regulators on potential next steps for the person.

As you can see 2022 is an important year for Biogen R&D with several important milestones expected as we continue to advance a diversified pipeline that contains a total of 32 clinical programs with 10 programs in either phase III or being flat.

Priya Singhal: These milestones include key regulatory filings, mid to late stage readouts in both Alzheimer's disease and neuropsychiatry, initiating late stage studies in Parkinson's disease, and starting a pivotal study in cutaneous lupus erythematosus in addition to ongoing recruitment for two phase 3 lupus programs in SLE as well as planning next steps for the BIB 131 stroke program.

These milestones include key regulatory filings.

Mid to late stage Readouts in both Alzheimer's disease and neuropsychiatry.

<unk> of late stage studies in Parkinson's disease, and starting a pivotal study in cutaneous lupus erythematosus. In addition to ongoing recruitment for two phase III lupus programs in Italy, as well as planning next steps for the Big 131 stock program.

Mike Mcdonnell: In summary, we are taking actions that we believe will enable delivery of a number of potential first-in-class and best-in-class molecules to patients suffering from diseases with significant unmet need. I will now pass the call over to. Thank you, Priya, and good morning everyone. I will provide some key highlights around the financial performance for the quarter and review our full year 2022 guidance. Please note that all financial comparisons are versus the prior year unless otherwise noted. Total revenue for the first quarter was $2.5 billion.

In summary, we are taking actions that we believe will enable delivery of a number of potential first in class and best in class molecules to patients suffering from diseases with significant unmet need I will now pass the call over to Mike.

Mike Mcdonnell: Our MS business, inclusive of Okravis Royalties, delivered $1.6 billion in revenue. Techvidera continues to be impacted by generic entry in the U.S. and was negatively impacted by pricing pressure outside of the U.S. Umerity's first quarter global revenue was $128 million. We are pleased with Umerity's trajectory in the U.S. and are making good progress towards launching it in up to 20 markets outside the U.S. this year. Tysabri global revenue increased 3%.

Thank you Bree and good morning, everyone I will provide some key highlights around the financial performance for the quarter and review our full year 2022 guidance. Please.

Please note that all financial comparisons are versus the prior year unless otherwise noted.

Total revenue for the first quarter was $2 5 billion.

Our EMS business inclusive of <unk> royalties delivered $1 $6 billion in revenue.

<unk> continues to be impacted by generic entry in the U S and was negatively impacted by pricing pressure outside of the U S.

First quarter Global revenue was $128 million, we are pleased with the <unk> trajectory in the U S and are making good progress towards launching in up to 20 markets outside the U S. This year.

Mike Mcdonnell: In the U.S., Tysabri revenue benefited from favorable pricing that more than offset modest volume declines. Outside the U.S., we were pleased to see continued patient growth. Interferon global revenue declined by 23% due to the continued shift from injectable platforms to oral or high efficacy therapy. Moving now to SMA, Spinraza global revenue declined 9%.

Tysabri global revenue increased 3% in the U S. Tysabri revenue benefited from favorable pricing that more than offset modest volume declines outside the U S. We were pleased to see continued patient growth.

Interferon global revenue declined by 23% due to the continued shift from the injectable platforms to oral or high efficacy therapies.

Moving now to SMA spin Rozzer global revenue declined 9%.

Mike Mcdonnell: In the U.S., although revenue growth of 10% was driven by positive channel dynamics, we were encouraged to see new patient starts at the highest levels in over two years and a continued slowdown of discontinuations versus the prior quarter. Outside the U.S., the revenue decline was driven primarily by the timing of shipments in certain markets, competition, and negative currency impacts, partially offset by strong initial uptake in China, as this was the first full quarter since receiving national reimbursement in China.

In the U S. Although revenue growth of 10% was driven by positive channel dynamics, we were encouraged to see new patient starts at the highest levels in over two years and a continued slowdown in discontinuation versus the prior quarter.

Outside the U S. The revenue decline was driven primarily by the timing of shipments in certain markets competition and negative currency impacts partially offset by strong initial uptake in China. As this was the first full quarter since receiving national reimbursement in China.

Mike Mcdonnell: Global Spinraza revenue grew 7% versus Q4 of 2021, driven by solid sequential performance outside the US, as well as some seasonality dynamics in the US. Moving to our biosimilars business, revenue declined 5%. While volume increased, this was more than offset by pricing pressure and a negative currency impact. In April, we completed the transaction to sell our equity stake in our Biosimilar joint venture. As a reminder, the economics for anti-TNF and ophthalmology programs will be substantially unchanged.

Global <unk> revenue grew 7% versus Q4 of 2021, driven by solid sequential performance outside the U S as well as some seasonality dynamics in the U S.

Moving to our Biosimilars business revenue declined 5%, while volume increase this was more than offset by pricing pressure and negative currency impacts.

In April we completed the transaction to sell our equity stake in our Biosimilar joint venture as a reminder, the economics for anti TNF in ophthalmology programs will be substantially unchanged.

Mike Mcdonnell: In addition, we are preparing to launch BioViz in the U.S. in the coming months. We expect a gradual launch with more meaningful revenue contributions starting in 2023. Overall, we expect full-year biosimilars revenue to decrease versus the prior year due to pricing pressure in Europe. Total anti-CD20 revenue grew 3%, with increased Ocrevus royalties being partially offset by a continued decline in Rituxan revenues due to biosomal competition. First quarter gross margin was negatively impacted by a $275 million charge for Aginhelm inventory write-off, as well as approximately $45 million of idle capacity charges.

In addition, we are preparing to launch <unk> in the U S in the coming months.

We expect a gradual launch with more meaningful revenue contribution starting in 2023 overall, we expect full year biosimilars revenues to decrease versus the prior year due to pricing pressure in Europe .

Total anti CD 20 revenue grew 3% with increased <unk> royalties being partially offset by a continued decline in rituxan revenues due to biosimilar competition.

First quarter gross margin was negatively impacted by a $275 million charge for agile inventory write offs as well as approximately $45 million of idle capacity charges note that ASI share of these charges is reflected in the collaboration profit sharing line.

Mike Mcdonnell: Note that a size share of these charges is reflected in the collaboration profit sharing. Moving now to expenses and the balance sheet, Q1 non-GAAP R&D expense was $552 million. Non-GAAP SG&A was $635 million, including approximately $80 million related to Agilent.

Moving now to expenses and the balance sheet.

Q1, non-GAAP R&D expense was $552 million non-GAAP , SG&A was $635 million, including approximately $80 million related to add yourself.

<unk> share of these costs are also reflected in the collaboration profit sharing line.

Mike Mcdonnell: A-size share of these costs is also reflected in the collaboration profit sharing. First quarter collaboration profit sharing reduced our net operating expense by $117 million, which includes reimbursement of approximately $182 million from ASI, partially offset by $64 million of net profit-sharing expense related to our collaboration with Samsung BioEther. In the first quarter, we generated approximately $162 million in cash flow from operations, which was negatively impacted by the timing of certain payments.

First quarter collaboration profit sharing reduced our net operating expense by $117 million, which includes reimbursement of approximately $182 million from ASI part.

Partially offset by $64 million of net profit sharing expense related to our collaboration with Samsung Bioweapon.

In the first quarter, we generated approximately $162 million in cash flow from operations, which was negatively impacted by the timing of certain payments.

Mike Mcdonnell: Capital expenditures were $58 million, and free cash flow was approximately $104 million. We ended the quarter with $7.3 billion in debt, $4.8 billion in cash and marketable securities, and $2.5 billion in net debt. Additionally, we subsequently received approximately $1 billion from the sale of our JV equity to Samsung Biologic. Additionally, our $1 billion revolving credit facility was undrawn as of the end of the quarter.

Capital expenditures were $58 million in free cash flow was approximately $104 million. We ended the quarter was $7 3 billion in debt $4 $8 billion in cash and marketable securities and $2 5 billion and net debt.

We subsequently also received approximately $1 billion from the sale of our JV equity to Samsung Biologics. Additionally, our $1 billion revolving credit facility was undrawn as of the end of the quarter. Overall, we remain in a very strong financial position with significant cash and financial capacity to invest in growing the business.

Mike Mcdonnell: Overall, we remain in a very strong financial position with significant cash and financial capacity to invest in growing the business over the long term. Let me now turn to our updated full-year guidance for 2022. We are reaffirming our full-year revenue guidance of $9.7 billion to $10 billion.

Over the long term.

Mike Mcdonnell: This revenue guidance reflects the strengthening of the U.S. dollar from January 1st through April 29th, resulting in an estimated currency headwind of approximately $120 million net of hedging activity. We are also reaffirming our full year non-GAAP diluted EPS guidance of $14.25 to $16.00 despite the $0.76 impact of Agihelm inventory write-offs, as well as an impact of approximately $0.35 related to the Although our prior guidance did not assume either the inventory write-offs or the currency headwinds, we believe the additional cost measures announced today, as well as better performance in our base business, can largely offset these impacts.

Let me now turn to our updated full year guidance for 2022, we are reaffirming our full year revenue guidance of $9 $7 billion to $10 billion. This revenue guidance reflects the strengthening of the U S. Dollar from January one through April 29th, resulting in an estimated currency headwind of approximately 120 million.

<unk>.

Net of hedging activities.

We are also reaffirming our full year non-GAAP diluted EPS guidance of $14 25 to.

To $16. Despite the 76 cent impact of ads at home inventory write offs as well as an impact of approximately 35 cents relate.

Related to the strengthening of the dollar that I just mentioned.

Although our prior guidance did not assume either the inventory write offs or the currency headwinds. We believe the additional cost measures announced today as well as better performance in our base business can largely offset these impacts.

Mike Mcdonnell: This financial guidance assumes continued declines in Rituxan revenue due to biosimilar competition, as well as continued erosion of Tecfidera revenue in the U.S. due to generic entry. This guidance also continues to assume the potential entry of generic Tecfidera into the EU in the second quarter of 2022. We expect decreased revenue from these high-margin products as well as the Agilent home inventory charges to reduce our gross margin percentage when compared with 2021.

This financial guidance assumes continued declines in rituxan revenues due to biosimilar competition as well as continued erosion of <unk> revenue in the U S. Due to generic entry. This guidance also continues to assume the potential entry of <unk> generics in the EU in the second quarter of 2022.

We expect the decreased revenue from these high margin products as well as the age of home inventory charges to reduce our gross margin percentage when compared with 2021.

Mike Mcdonnell: This guidance reflects the initial implementation of the additional cost reduction and productivity measures, which Michelle discussed. These additional measures are expected to yield approximately $500 million in annualized savings, in addition to the previously communicated initiatives already targeting approximately $500 million in annualized savings. This brings total expected annualized savings to approximately $1 billion, a portion of which will be reinvested in strategic initiatives over the coming years. We expect non-GAAP R&D expenses to be between $2.2 billion and $2.3 billion, which is unchanged from our previous guidance.

This guidance reflects the initial implementation of the additional cost reduction and productivity measures, which Michel discussed. These additional measures are expected to yield approximately $500 million in annualized savings. In addition to the previously communicated initiatives already targeting approximately $500 million in annualized savings.

This brings total expected annualized savings to approximately $1 billion, a portion of which will be reinvested in strategic initiatives over the coming years.

We expect non-GAAP R&D expense to be between $2 2 billion and $2 $3 billion, which is unchanged from our previous guidance.

Mike Mcdonnell: Non-GAAP SG&A expense is expected to be between $2.3 billion and $2.4 billion, which is a decrease from prior guidance of $2.5 billion to $2.6 billion, which is due to the additional cost reduction measures just mentioned, which we expect to primarily impact the third and fourth quarters.

non-GAAP SG&A expense is expected to be between $2 3 billion and $2 4 billion, which is a decrease from prior guidance of $2 5 billion to $2 6 billion.

Which is due to the additional cost reduction measures just mentioned, which we expect to primarily impact the third and fourth quarters.

Mike Mcdonnell: This guidance assumes that foreign exchange rates as of April 29th will remain in effect for the remainder of the year, net of hedging activities, and does not contemplate any further strengthening or weakening of the dollar throughout the year. Additionally, we assume that we will utilize a portion of the remaining share repurchase authorization of $2.8 billion throughout the year. Please see our press release for other important guidance assumptions. In summary, we continue to execute on our core business objectives this quarter and are now focused on a set of near-term operational priorities which we believe can drive value creation over time.

This guidance assumes that foreign exchange rates as of April 29th will remain in effect for the remainder of the year net of hedging activities and does not contemplate any further strengthening or weakening of the dollar throughout the year.

We assume that we will utilize a portion of the remaining share repurchase authorization of $2 8 billion throughout the year. Please.

Please see our press release for other important guidance assumptions.

So in summary, we continue to execute on our core business objectives. This quarter and are now focused on a set of near term operational priorities, which we believe can drive value creation over time, we'll now open the call for questions.

Mike Mcdonnell: We'll now open the call to questions. If you would like to ask a question, please press star 1 on your telephone keypad. As a reminder, please limit yourself to one question. If you require any further follow-up, you may press star 1 again to rejoin the queue.

If you would like to ask a question. Please press star one on your telephone keypad as a reminder, please limit yourself to one question. If you require any further follow ups you May press star one again to rejoin the queue.

Operator: Your first question comes from the line of Matthew Harrison from Morgan Stanley. Please go ahead. Great. Good morning.

Your first question comes from the line of Matthew Harrison from Morgan Stanley . Please go ahead.

Matthew Harrison: Thanks for taking the question. Michelle, I was hoping you could comment on the CEO transition here in terms of timing as well as what the board is looking for in terms of the successor and wish you all the best in the transition. Thank you. Thank you, Matthew. You know, five and five and a half years is a good term.

Great. Good morning, Thanks for taking the question Michelle.

Michel I was I was hoping you could comment on the CEO transition here in terms of timing as well as what the board is looking for in terms of the successor.

And wishing you all the best in the transition. Thank you.

Okay.

Thank you Matthew.

Five.

Five and half years is a good term and.

Michelle Bunatsos: And, if you look at my professional history, this was approximately the tenure in every key posting that I've had. You know, I've given a lot, and I will continue to do so as a priority during the transition to support the team so that we can continue to deliver. Today we reaffirmed our guidance. The business momentum is going as well as it could despite the competition and the life cycle events that we are facing.

If you look at my my professionally sorry. This was approximately the tenure in every key posting that they've had.

I've given a lot and that will continue to do so as a priority during the transition to support the team. So that we can continue to deliver today, we reaffirmed our guidance the business momentum is growing as well as it could be despite the competition.

The lifecycle events that too that we are facing we are.

Michelle Bunatsos: We are excited about the readouts to come and, you know, the ADU and the anti-amyloid story is still unfolding. So the story will continue, and I'm very excited about the opportunity to have new readouts in that space that will best inform, you know, everything we've heard, including decisions. So the CEO transition is a natural event, and is there always an ideal timing? I'm not sure.

Exciting, but excited about the readouts to come in and.

I do and the NTN below your story is still unfolding. So the story will continue and I'm very excited about the opportunity to have new readouts in that space that will best inform.

Everything we've heard including decisions.

The CEO transition is a natural event.

And is there always an ideal timing I'm not sure, but I think that I think that after five and half years, while we have a strategy that is a pretty visible to all of you being a specialized company neuroscience with some immuno assets.

Michelle Bunatsos: But I think that after five and a half years, while we have a strategy that is pretty visible to all of you, being a specialized company in neuroscience with some immunoassets that are very important, and in phase three with the biosimilars and digital health, I think the company is well positioned. It's good to have at one stage somebody else who comes with the support of the board and basically revisits the assumptions. So I think that this will be good for everyone involved. And my focus, again, will be on the company. It's not about me.

That's a very important in phase III with a biosimilar and digital health I think the companies well position. It's good to have a twin stage somebody else who comes with the support of the board and digitally habitually assumptions.

I think that the.

This will be this will be good for everyone involved and my focus again will be on the company. It's not about me it's about the company on the team and on the smooth transition business continues.

Michelle Bunatsos: It's about the company, the team, and a smooth transition. Business continues. I will be meeting all of you in the coming days in person in Boston and New York.

Meeting all of you in the coming days.

In person in Boston, and New York, I will be traveling with my team.

Michelle Bunatsos: I will be traveling with my team in Asia at the end of the week to meet our key partners and potential future partners and support our team and meet with PMDA also. So the business continues, and I will be at the top of it until the last second. We will now take our next question from Umer Raffat from Evercore. Please go ahead. Hi guys, thanks so much for taking my question. I guess I'll focus on cost for a second, and I guess I'm just trying to get at what the actual cost saving is.

In Asia at the end of the week to meet with key partners and potential future partners and support our team and meet with <unk> also so the business continues and I will be at the top of it.

Until the last second.

We will now take our next question from.

Rafi from Evercore. Please go ahead.

Umer Raffat: I'm partially confused because SG&A guidance was cut, but the, sorry, SG&A guidance was cut, but overall guidance was unchanged. Or maybe just a simple way to think about it is, where are we truly headed on OPEX over the next coming medium term? Because I just think back to when I first started covering Biogen; you were a leader in MS, you had over $4 billion in marketed MS revenues, but the SG&A was only a billion dollars.

Hi, guys. Thanks, so much for taking my question I guess I'll focus on cost for a second and then I guess I'm just trying to get at what is the actual cost savings partially confused because SG&A guidance was cut.

Sorry, SG&A was cut but the overall guidance was unchanged or maybe just a simple way to think about it is where are we truly headed on opex over the next coming medium term because I just think back to when I first started covering biogen.

We're a leader in EMS, we had over $4 billion in marketed MS revenues, but the SG&A was only a $1 billion now the marketed emmis revenues 5 billion, meaning a little higher but.

Umer Raffat: Now, the marketed MS revenues are 5 billion, meaning it's a little higher. But the SG&A is 2.5, and of course, you have some biosimilars and Spinraza, and I'm not necessarily saying 2.5 goes down to a billion, but can we see a substantial SG&A rebasing of the business? Thank you very much. Yeah, Umer, it's Mike.

But the SG&A is $2 five and of course, you have some biosimilars that's been raza.

And I'm not necessarily going to and how it goes down to 1 billion, but can we see a substantial SG&A rebating of the business. Thank you very much.

Mike Mcdonnell: Thank you for the question. So, you know, the cost savings that we mentioned today, the additional $500 million run rate, you know, that will be largely tied to the Agilent home infrastructure. And we talked about that in our last call that we initially expected about a $400 million number in 2022. And so, obviously, that'll be cut substantially. So in the SG&A guide, where we took that down by about $200 million, that is largely a significant piece of it.

Yes, it's Mike. Thank you for the question so.

The cost savings that we mentioned today, the additional $500 million.

Run rate.

That will be largely tied to the agile home infrastructure and we've talked about that on our last call that we had initially expected about a $400 million number.

In 2022, and so obviously that will be cut substantially so in the SG&A guide, where we took that down by about $200 million.

Mike Mcdonnell: Beyond that, we will obviously look at some of the non-revenue-facing pieces in G&A and others in order to achieve that run rate. And as we've said in our prepared remarks, we may invest certain portions of that $500 million in savings into future growth initiatives, with the overall priority being to return to growth. I will say in closing that, as it relates to guidance, we were able to reaffirm our guidance.

That that largely.

As a significant piece of it beyond that we will obviously look at some of the <unk>.

Non revenue facing pieces in G&A and others in order to achieve that run rate and as we've said in our prepared remarks, we may invest certain portions of that $500 million.

And savings.

Into the into future growth initiatives with the overall priority being to return to growth I will say in closing that as it relates to guidance.

We were able to reaffirm our guidance.

Mike Mcdonnell: Notwithstanding the inventory write-offs and the currency headwinds that we were facing, this was really the result of two things. One is the cost initiatives, and then the second is that the top line has performed a little bit better than what we had originally expected at the beginning of the year, and I would point to Spinraza MS as well as the CD20s being a little bit stronger than expected and that impact between the cost savings and revenue.

Notwithstanding the inventory write offs and the currency headwinds that we're facing and that was really a result of two things one is the cost initiatives.

And then the second was.

That the top line has performed a little bit better than what we had.

Originally expected at the beginning of the year and I would point to.

It's been raws at MFS.

As well as the CD 20, as being a little bit stronger than expected and that impact between the cost savings and the revenue, it's about half and half that contribute to our ability to hold the EPS in the same place. So we will continue to take necessary cost measures to align with the revenue trajectory of the business and hopefully that's some helpful color.

Mike Mcdonnell: It's about half and half that contribute to our ability to hold the EPS in the same place. So we'll continue to take necessary cost measures to align with the revenue trajectory of the business, and hopefully that's some helpful color. And a couple of comments to consider, Umer.

And a couple of comments to consider it.

Michelle Bunatsos: The first one is that at the time you started to cover, it was mostly U.S. business only. Okay, and this is not the case today, and the second point is that there were very few GMTs in the class, and now it's extremely crowded, and Biogen is still the leader globally in each one of those, being SMA, being MS, and being NTTNS in Europe. So this takes some muscle and, obviously, skills, and we... You know, we have made tremendous progress in terms of using digitalization and all the means of engaging, but we get the point, and this is compounded by the investment we made in Aduhelm that we eliminated. We will now take our next question from Robyn Karnauskas from Trust Securities. Please go ahead. Hi, thanks for taking my question. So the first one was just for Priya.

The first one is that.

At the time, where you started to cover it was mostly a U S business only.

Okay and this is not the case today and the second point is that there were very few DMT in the class and now it's extremely crowded and Biogen still the leader globally in each one of those being SMA being EMS and being <unk> in Europe . So this takes some muscles and obviously skills and.

We are.

We have made tremendous progress in terms of utilization and all the means of engaging.

But we get the point and this is compounded by the investments we have made on as you heard that we're eliminating.

We will now take our next question from Robyn <unk> from Trust Securities. Please go ahead.

Hi, Thanks for taking my question.

Robyn Karnauskas: You talked about how, you know, new data showing leukaemab, when you stop it, it suggests that, you know, you could have some decline in cognition. Can you just talk about any more updates as to why you think that is and if you think there's a difference in the mechanism versus Lilly's drugs? Another thing you mentioned. You also mentioned potentially divesting products. I wanted to know if you could elaborate on what you were referring to. Thank you. Priya Yes.

So the first one was just for <unk> you had talked about how new data showing the kind of mab.

When you stop it suggests that you know you could.

I have some declines at cognizant.

You just talk about any more updates as to why you think that is and if you think there is a difference in the mechanism versus Lilly drug.

And other thing you mentioned you did mentioned also about potentially divesting products I Wonder if you wanted to know if you could elaborate on what.

You're referring to you. Thank you.

Yeah, yes. Thank.

Priya Singhal: Thank you for that question. So, first of all, let me touch on Leucanomab. I think that the data that I referred to is data from the gap period in the open label, which was followed by the open label extension in the Phase 2 study. And I think what it shows you is that the science on this aspect of what is the ideal treatment duration is emerging. And that's really the point that we need to kind of take away from this. The field is evolving. There were two biomarkers, A beta 42 to 40 ratio, as well as plasma phospho tau 181, and we saw a reversal in both in the wrong direction.

Thank you for that question. So first of all let me touch upon them to count them up I think that the data that I referred to is data from the GAAP <unk>.

In the open label, which was followed by the open label extension in the Phase II study and I think what it shows you is that the science on this aspect of what is the ideal treatment duration is emerging.

And that's really the point that we need to kind of take away from this for the field is evolving there were two biomarkers EBIT of 42 to 40 ratio as well as plasma first put out 181, and we saw a reversal in boat.

In the wrong direction, so I think that.

Priya Singhal: So I think that how we're trying to address this is ESA is actually taking a lead on it because they are assessing how maintenance can be applied, and they're doing this in their open-label extension in the phase two study. So there's probably more data that will come out in the upcoming period as they learn more. And I think with the nanomab, you asked me for a comparison. I can only speak to the data that I've seen in the public domain.

How were trying to address this is E size actually taking a lead on it because they are assessing how maintenance can be applied and they're doing this in their open label extension in the phase II study. So there is more data probably that will read out in the upcoming period.

We learn more and I think with the nano Mab you asked me for a comparison I can only speak to the data that I've seen in the public domain and I think that what we haven't seen is the after effects of long term follow up we haven't seen a similar effect of what happens to amyloid blocks of what happens to fast foot al <unk>.

Priya Singhal: And I think that what we haven't seen is the after effects of long-term follow-up. We haven't seen a similar effect of what happens to amyloid plaques or what happens to phospho tau once licanumab is stopped. And I think that that data would be relevant for us to make a fair comparison. At the moment, I think what we believe, along with ESI, and what we see is that stopping prematurely can cause a reversal.

<unk> Mab is stopped and I think that that data would be relevant for us to make a fair comparison at the moment I think what we believe along with ESI and what we see is that stopping prematurely can cause of duvelisib.

Priya Singhal: So hopefully, that answers that part of the question, and then the second part of your question was about divestiture. And I'll just step back and say that we are looking across our entire portfolio, our R&D portfolio, and making integrated decisions on prioritization. What do I mean by this?

So hopefully that answers that part of the question and then the second part of your question was about divestiture.

And ill just step back and say that we are looking across our entire portfolio our R&D portfolio.

And making integrated decisions on prioritization, what do I mean by this I mean that we're looking at are disease areas. We're looking at our therapeutic areas. We're looking at where we are leaders, where we have a lot of internal expertise and we are prioritizing accordingly, and being good stewards of the source.

Priya Singhal: I mean that we're looking at our disease areas, we're looking at our therapeutic areas, we're looking at where we are leaders, where we have a lot of internal expertise, and we are prioritizing accordingly and being good stewards of resources. So this is also driven in part by internal and external readouts. For example, you know, we've just filed for the Rana loan. This is a very exciting step for us in neuropsychiatry, and we are expecting an upcoming readout for BIB 104, which is for cognitive impairment associated with schizophrenia.

So this is also driven in part by internal and external Readouts for example.

We've just filed was around alone. This is a very exciting step for us.

In neuropsychiatry, and we are expecting an upcoming readout for <unk> 104, which is for cognitive impairment associated with schizophrenia. So we'll see what that readout shows us, but again, we will anchor to areas, where we have success, we have expertise and built around those areas. The same goes for lupus.

Priya Singhal: So we'll see what that readout shows us. But again, we will anchor to areas where we have success, where we have expertise, and build around those areas. The same goes for lupus.

Priya Singhal: We have three programs in lupus, and we will continue to build out those areas as we see readouts and data. We may also consider expanding indications. So everything's really on the table, and we're trying to be very disciplined about an integrated prioritization and methodology. Now within that integrated prioritization, we may have assets where we believe that they may have, you know, been better utilized by partnering them or by externalizing them. This is what I meant by divest. So hopefully, that addresses it. It's just one part of a much larger, synchronized, integrated R&D strategy.

We have three programs in lupus and we will continue to build out those areas as we see readouts and data.

We also consider expansion of indications. So everything is really on the table and we're trying to be very disciplined about an integrated prioritization and methodology now within that integrated prioritization, we may have assets, where we believe that they have.

The better utilized by partnering them or by externalizing them. This is what I meant by divest so hopefully that addresses. It is just one part of a much larger synchronized integrated R&D strategy.

Thank you.

Priya Singhal: Thank you. Operator, we'll take the next question, please. Operator, if you're there, we cannot hear you. Okay, we're having technical difficulties. We'll try to rejoin the call.

Operator, we'll take the next question please.

Operator, if you're there we cannot hear you.

Yeah.

Okay, we're having technical.

Difficulties will try to rejoin the call.