Q3 2020 Biogen Inc Earnings Call
Ladies and gentlemen, good morning, My name is <unk> and I will be your conference operator today.
Operator: Ladies and gentlemen, good morning. My name is Abbey, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen 3rd Quarter Earnings Call and Financial Update. All lines have been placed on mute to prevent any background noise.
At this time I would like to welcome everyone to the Biogen third quarter earnings call and financial update a lot.
All lines have been placed on mute to prevent any background noise.
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.
Operator: After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star 1 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.
Operator: If you require any further follow-up, you may press star 1 again to rejoin the... Thank you, and I would now like to turn the conference over to Mr. Joe Marra, Vice President, Investor Relations. Mr. Marra, you may begin your conference. Thank you, and good morning, and welcome to Biogen's third quarter 2020 earnings call. Before we begin, I encourage everyone to go to the investor section of biogen.com to find the earnings release and related financial tables, including a reconciliation of the gap to non-gap financial measures that we will discuss. Our GAAP financials are provided in Tables 1 and 2, and Table 3 includes a reconciliation of our GAAP to non-GAAP financial results and our GAAP to 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.
Thank you and I would now like to turn the conference over to Mr., Joe Mora, Vice President Investor Relations Mr. <unk> you may begin your conference.
Thank you and good morning, and welcome to Biogens third quarter 2020 earnings call.
Before we begin I encourage everyone to go to the investors section of barge and Dot Com <unk> earnings release and related financial tables, including a reconciliation of the GAAP to non-GAAP financial measures, we will discuss today.
Our GAAP financials are provided in the tables, one and two in table. Three includes a reconciliation of our GAAP to non-GAAP financial results and our GAAP to non-GAAP financial guidance, we believe.
We believe non-GAAP financial results better represent the ongoing economics of our business and reflect how we manage the business internally we have.
We have also posted slides on our website that followed the discussions related to this call.
Joe Marra: 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, 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 would 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.
Joe Marra: 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 Bonazzos, Dr. Al Sandrock, EVP, Research and Development, and our CFO, Mike McDonnell. Now, I will turn the call over to Michelle.
I heard you to consult the risk factors discussed in our atrophy filings for additional detail on today.
On today's call I'm joined by our Chief Executive Officer, Michelle, but not so dr. al Sandrock, you need the research and development and our CFO, Mike Mcdonnell now I will turn the call over to Michelle.
Michelle Bonazzos: Good morning, everyone, and thank you for joining us. As you all know, the Aducadimab Advisory Committee meeting is scheduled for November 6. This is our highest priority, and we are very focused on preparing for this meeting. At the same time, the tech regulatory situation in the U.S. is clearly a near-term challenge, which we will discuss.
Good morning to everyone and thank you for joining us as you all know I'd you could be by the Advisory Committee meeting each student to under six you see though Oh, yes, probably always <unk> and we are very focused on preparing for this meeting I just.
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Michelle Bonazzos: Before I continue, I'd like to welcome Mike McDonnell, our new CFO. Mike's background and track record of accomplishment make him well-prepared to be a very strong contributor to Biogen, and I know he looks forward to getting to know many of you. Now, let me review some key recent developments. First, we are very pleased that the FDA has accepted our BLA for aducanumab with priority review and has stated that, if possible, they plan to act early. As I mentioned, the Advisory Committee is, of course, an important event on the path to potential approval, and we are actively preparing to participate and share our perspective on our clinical data. Outside the U.S., early this month, we submitted a marketing authorization application in Europe, and we are preparing for a regulatory submission in Japan following a recent formal meeting with the PMDA.
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And we are preparing for I think you'd have to re submission in Japan. Following a recent formal meeting we the PMG.
Michelle Bonazzos: We have progressed in our U.S. launch readiness as we remain focused on appropriate engagement with scientific leaders, defining treatment sites, Defining adecanumab's value proposition, and establishing collaboration across multiple stakeholders to help prepare for the potential introduction of the first therapy to meaningfully change the course of Alzheimer's disease. Outside the U.S., we are continuing to update our launch readiness, particularly in Europe and Japan.
We have no question, our U.S. don't trade units as we remain focused on Apple kids engagement suite sense, if he does.
Treatment sites.
Do you find you have you got any loves the value proposition and establishing collaboration across multiple single dose to help prepare for the potential introduction of the first step in to meaningfully change the call sometimes I'm his duties.
Outside the U.S., we are continuing to up that the old treaty that specifically in Europe and Japan.
Michelle Bonazzos: Beyond ADKNIMAB, we continue to advance our broader Alzheimer's disease portfolio, including BAN 24-1 in Phase 3 and multiple programs targeting TARO. Also, in neurodegeneration, we are proud to be collaborating with Denali, a premier innovative neuroscience company pioneering novel approaches for treating brain diseases. This collaboration provides us with a mid-stage small molecule LRRK2 inhibitor program that expands our pipeline of potential therapies in Parkinson's disease across multiple modalities.
Beyond that you couldn't model, we continue to advance our brother I lose these portfolio, including button Ttwenty, four wanting say sweet and meet people stuck it seems difficult times that get you Tal.
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Modalities.
Michelle Bonazzos: We also received exclusive option rights to two programs for neurodegenerative diseases using NALI's innovative transport vehicle platform, including for amyloid beta antibodies. With a deep pipeline, aducanumab now under review, and our recent collaboration with Denali, we believe we are well positioned to lead in the fight against both Alzheimer's disease and Parkinson's disease, the number one and number two most common neurodegenerative diseases with an urgent need for novel treatments. More broadly, we have continued to develop and expand our DEEP pipeline, which now includes 30 clinical assets, with 8 in phase 3 of 5, including the recent initiation of the Phase III program for Dipyrolizumab-Pegol in lupus with UCB. 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 investments over both the short and the long term.
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As we have demonstrated in the past we are committed to maximizing returns for shareholders. As we aim to be you know that keeps that piece to patients something that demands. It's subdued approach towards auto investments over both the short and the long term.
Michelle Bonazzos: Let me now discuss where we see Biogen strategically as we are in a transitional period with several upcoming inflection points. As we manage through the erosion of the tech federa in the U.S., Biogen remains focused on strong execution against our strategies. We are the leader in neuroscience with differentiated core capabilities as we aim to leverage breakthrough science to address the tremendous unmet medical need in this space. For example, we are leveraging better understanding of disease biology, including the underlying genetics. As well as advances in biomarkers, such as novel imaging of the brain, to help reduce the risk of developing therapies for many previously intractable diseases.
Let's now discuss where we see Biogen started you can be as we do we are you know trials each was not very good we've several upcoming inflection points.
As we manage through the erosion of 69, B.U.S. Biogen remains focused on strong execution against our strategy.
We are the leader no science, we differentiated <unk> Cold Cup WB TV ads.
We aim to get rate, you're bringing science to address the tremendous unmet medical need in this space, we are leveraging better understanding of disease biology, including the underlying genetics as well as advances in biomarkers, such as mobile matching up the brain to help reduce.
The risking developing therapies for men he couldn't you ski intractable diseases.
Michelle Bonazzos: We are building on a strong financial track record with a core business in MS, SMA, and biosimilars, and we believe we are entering a new phase of important clinical readouts and value creation opportunities. We will continue to work to maximize the potential of our broad MS portfolio, including the launch of Umerity and lifecycle management for Tysabri and Interferon. Despite increased competition, we believe Spinoza can continue to grow and serve as a foundation of care based on the most well-established efficacy and safety profile in SMA. Spinoza has demonstrated sustained clinically meaningful benefit from pre-symptomatic infants to adults, and its safety profile has enabled us to begin assessing a higher dose for potentially even greater efficacy.
We are building on the strong financial truck recalled we the coal business in the <unk> and but you'll see me jobs and we believe we are entering a new phase of important people read outs and value creation opportunities [noise].
We will continue to work to maximize the potential of our broad and lets portfolio, including the launch of humility and lifecycle management for Tysabri and beat interference.
Despite increased competition, we believe spinraza can continue to grow and serve as a foundation of care based on the most well established if he does she and safety profile yesterday.
It's been a lot of that has demonstrated sustained clinically meaningful benefits from pre symptomatic infants audits.
And its safety profile has enabled us to begin assessing how your doors for potentially even a greater if he gets cheap.
Michelle Bonazzos: We see biosimilars as another potential growth driver while providing headroom for innovation. We are working to expand into the U.S. and China with the potential to commercialize two new ophthalmology biosimilars with a global market opportunity of approximately $11 billion. Importantly, Samsung BioApps recently announced that a marketing authorization application was accepted by the EMA for SB11, a potential biosimilar, referencing licensees.
We see balance sheet allows us another potential growth driver, while providing headroom for innovation.
We are working to expand into the U.S. in China, we have the potential to commercialize student you will spend more did you, but you will see me knobs, we the global market opportunity of having some actually $11 billion.
Importantly, Samsung evaluate piece recently announced that the marketing authorization application was accepted by the EMA <unk>, it's been 11, it potentially but you'll see me now if parents seemed incentives.
Michelle Bonazzos: We remain optimistic about the prospect of launching Aducanimab as the first therapy to meaningfully change the course of Alzheimer's disease, and this will be an important short-term and long-term growth driver for the company. In addition, as you can imagine, we believe our pipeline could enable a second wave of growth in the mid-2020s, driven by areas such as ophthalmology, stroke, lupus, and ALS. Importantly, we expect six mid- to late-stage data redoubts by the end of 2021. We plan to continue pursuing external business development opportunities to further expand our pipeline. In just under four years, we have committed nearly $5 billion to business development and executed 20 transactions. Going forward, we will continue to prioritize the stability of our organization to support our current portfolio while preparing for the potential introduction of a number of new products, starting with Aducanimab. We will be focused on dividend execution, capturing every opportunity for efficiency and cost savings.
We remain optimistic about the prospect of launching as you can imagine I've. This recipe to meaningfully change the course of disease and this would be an important short term and long term growth driver for the company.
In addition to what you're getting not you know it.
Pipeline could enable a second wave of growth in the mid Twentys twentys driven by our routes such as an offset Moto G stroke, you produce and yes in both.
Importantly, we expect seeks mid to late stage discovery doubts baby and Oh Slinky 21.
We plan to continue pursuing external business development opportunities.
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Going forward, we will continue to prioritize the stability of our organization to support our current portfolio, while preparing for the potential introduction of a number of new products stocking. We've as you can imagine.
We'd be focused on de jumping execution, capturing every opportunity for efficiency and cost savings.
Geoffrey Christopher Meacham: In summary, we have continued to execute well on our strategy. We believe we are well positioned to serve our current and future patients as we build a multi-franchise portfolio, leveraging the interconnectivity of our deep neuroscience pipeline. We have a very strong balance sheet, and we remain focused on maximizing long-term value creation. I will now turn the call over to Al for a more detailed update on our recent progress in R&D. Thank you, Michelle, and good morning, everyone.
In summary, we have continued to exhibit went on I was teaching we believe we are well positioned to serve our current and future patients as we believe it would be franchise portfolio leveraging the interconnectivity of our deep neuroscience pipeline.
We have a very strong balance sheet and we remain focused on maximizing long term showed the value creation I wouldn't.
I will now turn the call over to either for a more detailed update on our recent progress in R&D.
Thank you Michelle and good morning, everyone.
Geoffrey Christopher Meacham: I'd like to begin by thanking the Biogen team for their hard work in making significant progress advancing our R&D program. This includes milestones across key areas such as regulatory filings for AgiCanumab, pipeline progression, and business development. Starting with Alzheimer's disease, as Michelle mentioned, we are working through the regulatory procedures for aducanumab around the world. We are also diligently preparing for the FDA Advisory Committee meeting on November 6. Also in Alzheimer's disease, our collaboration partner, ACI, will enroll the first patient in the AHEAD 345 clinical program, which is designed to evaluate BAN2401 in individuals with preclinical Alzheimer's disease. Through the results of this trial, we hope to learn whether BAN2401 can suppress the progression of amyloid and tau pathology and reduce cognitive decline in the very early stages of Alzheimer's disease. This quarter, we also announced an exciting collaboration with Denali Therapeutics to co-develop and co-commercialize Denali's small molecule LORC2 inhibitor DNL-151 for Parkinson's disease, the second most common neurodegenerative disease. LRRK2 is a negative regulator of lysosomal function, and certain mutations in the LRRK2 gene increase the risk of Parkinson's disease.
I'd like to begin by thanking the Biogen team for their hard work in making significant progress advancing our R&D programs. This income.
This includes milestones across key areas, such as the regulatory filings or that you can you map pipeline progression and business development.
Starting with all side in this disease.
Michelle mentioned, we are working through the regulatory procedures for educating that around the world.
We're also diligently preparing for the FDA Advisory Committee meeting on November six.
Also in Alzheimer's disease, our collaboration partner site dose the first patient in the <unk> had three four or five clinical program, which is designed to evaluate band two 401 in individuals with the preclinical Alzheimer's disease.
Through the results of this trial, we hope to learn whether ban to for all one can suppress the progression of amyloid and tell pathology and reduce cognitive decline in the very early stages of Alzheimer's disease.
This quarter, we also announced an exciting collaboration with Denali therapeutics to co develop and co commercialize the knowledge small molecule work two inhibitor BNL 151 in Parkinson's disease, the second most common or a degenerative disease.
Work too was a negative regulator of lysosomal function and certain mutations and alert to just increase the risk of Parkinson's disease.
Geoffrey Christopher Meacham: We will examine the therapeutic potential of LRRK2 kinase inhibition in patients with and without known genetic risks for Parkinson's disease. Our hope is that 151 could be a first-in-class oral therapy that slows the progression of the disease. This collaboration also provides us with the exclusive option to license two preclinical programs utilizing Denali's transport vehicle platform. This platform is designed to enhance the brain uptake of large therapeutic molecules by leveraging the transferrin receptor, which is highly expressed at the blood-brain barrier.
We will examine the therapeutic potential of work to kinase inhibition in patients with and without known genetic risks for Parkinsons disease.
Our hope is that 151 could be a first in class oral therapy that slowed the progression of the disease.
This collaboration also provides us with the exclusive option to license two preclinical programs utilizing the knowledge transport vehicle platform.
This platform is designed to enhance the brain uptake of large therapeutic molecules by leveraging the transfer and receptor which is highly expressed at the blood brain barrier.
Geoffrey Christopher Meacham: One of these two programs seeks to enhance the delivery of an anti-beta amyloid antibody across the blood-brain barrier. We are pleased to be collaborating on this platform with Denali, a pioneer in enhancing the delivery of large molecules into the central nervous system. Moving to our MS portfolio, at the ECTCOMS meeting last month, we presented new data from the EVOLVE MS-2 trial that further reinforced the clinically meaningful improvement in gastrointestinal tolerability associated with brumarity as compared to Tecfidera. Specifically, patients taking Bumeriti reported a lower likelihood of experiencing GI symptoms that interfered with daily activities or were associated with missed work, and they used less concomitant medication to treat GI symptoms.
One of these two programs seeks to enhance the delivery of an anti beta amyloid antibody across the brain barrier.
We are pleased to be collaborating on this platform with Denali, a pioneer and enhanced seem to be delivery of large molecules into the central nervous system.
Moving to our mass portfolio at the ECTRIMS meeting last month, we presented new data from the vault and that's two trial that further reinforce the clinically meaningful improvement in gastrointestinal tolerability associated with the narrative as compared to texture there.
Specifically patients taking too nerdy reported a lower likelihood of experiencing Gi symptoms that interfered with daily activities or were associated with missed work and use less concomitant medication to treat symptoms.
Geoffrey Christopher Meacham: Also at ECTRIMS, an analysis of real-world data in patients receiving Tysabri extended interval dosing showed no significant differences in the rates of new T2 lesions, T2 lesion volumes, or brain atrophy on brain MRI scans when compared to patients receiving the currently approved every four-week dosing regimen. These data contribute to a growing body of evidence that suggests that Tysabri extended interval dosing has similar efficacy to that of standard dosing while reducing the risk of PML. The efficacy of extended interval dosing as compared to the standard dosing regimen is being assessed prospectively in the ongoing NOVA study, which is expected to read out next year. Additionally, we presented real-world data showing that treatment with text fabrics was associated with significant improvement in 9 of 12 patient-reported NeuroQuality of Life domains, whereas in patients treated with Ocrevus, there were improvements in 4 of 12 domains.
Also at ACTRIMS, an analysis of real world data in patients receiving tysabri extended interval dosing showed no significant differences in the rates of new T. T. Two lesions T. Two leasing volumes or brain atrophy on brain MRI scans when compared to patients receiving the currently approved every.
Before week dosing regimen.
These data contribute to a growing body of evidence that suggests the tysabri extended interval dosing has similar efficacy to that of standard dosing, while reducing the risk of PML.
Yeah efficacy of extended interval dosing as compared to the standard dosing regimen is being assessed prospectively in the ongoing Nova study, which is expected to read out next year.
Additionally, we presented real world data show [noise] showing that treatment the tysabri.
Was associated with significant improvement in nine of 12 patient reported neuro quality of life domains, whereas in patients treated with Oaktree. Thus there were improvements in Fourq 12 domains.
Geoffrey Christopher Meacham: Moving to our MS pipeline, we were disappointed to learn that Affinity, the Phase 2B study of opicinumab, did not meet its primary endpoint or secondary endpoint. As a result, we have decided to discontinue development of opicinumab. Nevertheless, we remain committed to the therapeutic approach of repairing the central nervous system and still believe that remyelination has the potential to provide a therapeutic benefit for MS patients.
Moving to our M.S. pipeline, we were disappointed to learn that affinity the phase Twob study of opioid sentiment did not meet its primary endpoint or secondary endpoints.
As a result, we have decided to discontinue development of opioid sentiment.
Nevertheless, we remain committed to the therapeutic approach of repairing the central nervous system and still believe that remain one nation has the potential to provide a therapeutic benefit for M.S. patients.
Geoffrey Christopher Meacham: We are continuing to analyze the significant data set from this study to further inform our MS research in this area, including for BIB 61. Turning to neuromuscular disorders, following productive engagement with the FDA, we are advancing plans for a study to evaluate the benefit of profersin when initiated in pre-symptomatic carriers of SOD1 mutations that have been linked to ALS. Akin to the NURTURE study of Spinraza in SMA, this study is designed to evaluate the ability of a person to delay the clinical onset or slow the disease progression of ALS when initiated prior to clinical symptom onset.
We are continuing to analyze the significant dataset from the study for further inform our M.S. research in this area, including forbid 61.
Turning to neuromuscular disorders, following productive engagement with the FDA. We are advancing plans for a study to evaluate the benefit of to a person when they initiated in pre symptomatic carriers, a vessel or the ones mutations that have been linked to LLS.
I tend to the nurture study of Spinraza an estimate. This study is designed to evaluate the ability of to a person to delay clinical onset or slowed disease progression avail us when initiated prior to clinical symptom onset.
Geoffrey Christopher Meacham: We plan to initiate this study next year. Also, in ALS, I am happy to report that we dosed the first patient in our Phase 1 study of BID-105, an antisynthetic nucleotide targeting Ataxin-2. Ataxin-2 was originally identified as a modifier of TDP-43 toxicity, a pathology common to more than 90% of the ALS population, suggesting that reduction in Ataxin-2 could be therapeutic across most ALS populations, other than that due to SOD-1.
We plan to initiate the study next year.
Also in a less I'm happy to report that we dose the first patient in our phase one study of bid one o'five and antisense oligonucleotides targeting eightx into.
They tax into was originally identified as a modifier TDP 43 toxicity that pathology comment to more than 90% of the LSW population, suggesting that reduction in a texan too could be therapeutic could be therapeutic approach across most LS BOP populations and other than that do that.
Geoffrey Christopher Meacham: Additionally, I would like to provide an update on our SMA gene therapy asset, DIB89. The FDA had previously placed a clinical hold on BIB89 due to dorsal root ganglion toxicity, a pathology commonly observed in preclinical studies and which may also occur following use of the currently available AAV-mediated SMA gene therapy. Thus, we've made the decision to discontinue DIT-89 and will instead focus on the pursuit of next-generation SMA gene therapy technologies that we believe will address the DRG toxicity. Lastly, we are happy to announce that, in collaboration with UCB, we have dosed the first patient in our Phase III program for Depiralizumab Pegol in patients with systemic lupus erythematosus with active disease In summary, we continue to build and advance a deep neuroscience pipeline that seeks to address patients' needs by leveraging both organic growth and external collaboration.
So do you want.
Additionally, I would like to provide an update on our estimated gene therapy asset did 89.
Yes, the I had previously placed a clinical hold a bit 89 due to dorsen dose over ganglion toxicity of pathology, commonly observed in preclinical studies and which May also occur following use of the currently available is the mediated estimate gene therapy.
Thus, we made the decision to discontinue that 89 and will instead focus on the pursuit of next generation SMB gene therapy technology that we believe will address the DRG toxicity.
Lastly, we are happy to announce that in collaboration with U C. B, we have dosed the first patient in our phase three program for Decker realism add peggle in patients with systemic lupus erythematosus, but active disease, despite being on standard of care therapies.
In summary, we continue to build in advance it deep neuro science pipeline that seeks to enhance to address patients needs by leveraging both organic growth and external collaboration.
Geoffrey Christopher Meacham: This approach is evidenced by our recent agreement with Denali and also Scribe Therapeutics, where we are pursuing cutting-edge CRISPR technology to potentially develop gene therapies for ALS. We believe this mix of internal development and external collaboration allows us to maximize the value of our R&D programs and provide the source of sustained innovation to help drive long-term growth of the company. I will now pass the call to Mike. Thank you, Al. Good morning, everyone.
This approach as evidenced by our recent agreement with Denali and also scribe therapeutics, we're where we are pursuing a cutting edge CRISPR technology to potentially develop gene therapies for L.S.
We believe this mix of internal development and external collaboration allows us to maximize the value of our R&D programs and provides a source of sustained innovation to help drive long term growth of the company.
I will now pass the call to Mike.
Thank you al Good morning, everyone I'm excited to join Biogen and look forward to getting to know many of you.
Michael R. McDonnell: I'm excited to join Biogen and look forward to getting to know many of you. Biogen had another solid quarter despite the recent entrance of generic Tecfidera and the continued impacts of COVID-19 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 for the quarter and also provide an update on our full year guidance. Total revenue for Q3 was $3.4 billion, a decline of 6% versus the prior year. This decline was mostly driven by Tecfidera generic entry and is inclusive of a 1% unfavorable currency impact. Total MS revenue, including Accrevis Royalties, was $2.3 billion, a decrease of 4% versus the prior year.
Biogen had another solid quarter. Despite the recent entrance of generic tech the Dara and the continued impact of COVID-19, 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 also provided an update to our full year guidance.
Total revenue for Q3 was $3.4 billion, a decline of 6% versus the prior year. This decline was mostly driven by tech for their generic entry and is inclusive of a 1% unfavorable currency impact so.
Total M.S. revenue, including a previous royalties was $2.3 billion, a decrease of 4% versus the prior year.
M.S. revenue during the third quarter began to experience the impact of the entrance of multiple generics of tech for Dara in the U.S., well Q3 Tech Adair revenue outside the U.S. was $283 million, representing an increase of 1% versus the prior year with continued patient growth.
Michael R. McDonnell: MS revenue during the third quarter began to experience the impact of the entrance of multiple generics of Tecfidera into the U.S., while Q3 Tecfidera revenue outside the U.S. was $283 million, representing an increase of 1% versus the prior year, with continued patient growth. During the quarter, we saw improvement in plumerity trends, including an increased number of new patients. We believe Blumeri can be an important product given its differentiated GI tolerability profile, as Al mentioned. Tysabri had a strong quarter with Q3 global revenue of $516 million, growing 7% versus the prior year.
During the quarter, we saw improvement into a marriage he trends, including an increased number of new starts.
We believe the marriage he can be an important product given its differentiated Gi tolerability tolerability profile as al mentioned.
Tysabri.
Had a strong quarter with Q3 global revenue of $516 million growing 7% versus the prior year.
We were pleased to see continued global patient growth of 4% for tysabri versus the prior year.
We believe Tysabri is well positioned to play an increasingly important role in the treatment of M.S. and we are working on several important initiatives, including subcutaneous administration.
An option for a home infusion.
And an option for extended interval dosing.
Moving now to SDMA global third quarter, Spinraza revenue was $495 million, a decrease of 10% versus the prior year and stable versus the prior quarter.
Michael R. McDonnell: We were pleased to see continued global patient growth of 4% for Tysabri versus the prior year. We believe Kaisabi is well positioned to play an increasingly important role in the treatment of MS, and we are working on several important initiatives, including subcutaneous administration, an option for home infusion, and an option for extended interval dosing.
In the U.S. Spinraza revenue decreased by 23% versus the prior year as we continue to see an impact of COVID-19 on both new starts and maintenance doses as well as additional competition.
Outside the U.S. Spinraza revenue was stable versus the prior year and grew 10% versus the prior quarter.
Although COVID-19, and new competition have had an impact on spinraza, we see.
We see the potential for global growth, given a very strong efficacy and safety profile and a significant number of untreated patients across many established and emerging markets.
Michael R. McDonnell: Moving now to SMA, global third-quarter Spinraza revenue was $495 million, a decrease of 10% versus the prior year and stable versus the prior quarter. In the US, Spinraza revenue decreased by 23% versus the prior year, as we continue to see an impact of COVID-19 on both new starts and maintenance doses, as well as additional competition. Outside the U.S., Benraza revenue was stable versus the prior year and grew 10% versus the prior quarter.
Moving to our Biosimilars business revenue was $208 million this quarter, an increase of 13% versus Q3 2019.
Q3, Biosimilars revenue despite returning to growth continued to be negatively impacted by a slowdown in new treatments and reduce clinic capacity for immunology patients as a result of COVID-19.
Benepali, our first and largest bio similar became the number one prescribed etanercept product across Europe.
Michael R. McDonnell: Although COVID-19 and new competition have had an impact on Spinraza, we see the potential for global growth given its very strong efficacy and safety profile and the significant number of untreated patients across many established and emerging markets. Moving to our biosimilars business. Revenue was $208 million in this quarter, an increase of 13% versus Q3 2019. However, Q3 biosimilars revenue, despite returning to growth, continued to be negatively impacted by a slowdown in new treatments and reduced clinic capacity for immunology patients as a result of COVID-19. Benapali, our first and largest biosimilar, became the number one prescribed e-countercept product across Europe.
We estimate there are now approximately 220000 patients using our biosimilars in Europe, and we believe we have the opportunity to continue to grow in Europe, as well as potentially within the U.S. and other geographies.
Total anti CD 20 revenue in the in Q3 was $560 million a decrease of 6% versus the prior year with increased a previous royalties offset by decreased revenue former talks and due to covert at 19 and continued erosion from bio Similars a trend you expect to continue to impact.
Toxin.
Total other revenue in the third quarter increased 15% versus Q3 2019 to approximately $126 million.
Turning now to expenses Q3, GAAP R&D expense was $1.1 billion or 34% of revenue non-GAAP, R&D expenses, which excludes $601 million related to our collaboration with Denali was $540 million or 16% of revenue there.
Michael R. McDonnell: We estimate there are now approximately 220,000 patients using our biosimilars in Europe, and we believe we have the opportunity to continue to grow in Europe as well as potentially within the U.S. and other geographies. Total anti-CD20 revenue in Q3 was $560 million, a decrease of 6% versus the prior year, with an increase in previous royalties offset by decreased revenue from Rituxan due to COVID-19 and continued erosion from biosimilars, a trend we expect to continue to impact Rituxan. Total other revenue in the third quarter increased 15% versus Q3 2019 to approximately $126 million. Q3 GAAP R&D expense was $1.1 billion, or 34% of revenue.
Beginning in Q3 material upfront payments associated with significant collaboration and licensing arrangements are excluded from non-GAAP R&D expense in order to better reflect our core operating performance.
Year to date non-GAAP results also reflect this change as the $125 million upfront payment related to the collaboration with Sangamo in the second quarter of 2020.
Has also now been excluded from non-GAAP R&D expense.
Q3, GAAP EPS DNA expense of $573 million and non-GAAP EPS DNA of $569 million were both 17% of revenue.
Within the U.S., we are reallocating some tech for their resources to support the launch of America as well as as you can imagine, although we will continue to fully support our broader M.S. portfolio in it.
Michael R. McDonnell: Non-GAAP R&D expense, which excludes $601 million related to our collaboration with Denali, was $540 million, or 16% of revenue. Beginning in Q3, material upfront payments associated with significant collaboration and licensing arrangements are excluded from non-GAAP R&D expense in order to better reflect our core operating performance. Year-to-date non-GAAP results also reflect this change, as the $125 million upfront payment related to the collaboration with Sangamo in the second quarter of 2020 has also now been excluded from non-GAAP R&D expenses. Q3 GAAP SG&A expense of $573 million and non-GAAP SG&A of $569 million were both 17% of revenue.
In addition, we are ramping up our commercial preparations for AD you can imagine which will create some upward pressure on SGN AG.
However, as always we will continue to diligently manage our operating expenses to ensure we remain efficient across the organization.
In Q3 of this year, our effective GAAP tax rate was approximately 25% an increase from approximately 12% in the third quarter of 2019.
This increase is primarily due to prior year favorability from Swiss tax reform as well as current year, Unfavorability, primarily driven by noncash deferred tax adjustments related to Texas era.
For the third quarter of 2020, our effective non-GAAP tax rate was approximately 18% an increase from approximately 16% in the third quarter of 2019.
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Third quarter GAAP net income was $702 million and non-GAAP net income was $1.4 billion.
Michael R. McDonnell: Within the U.S., we are reallocating some Tecfidera resources to support the launch of Umerity as well as Aducanumab, although we will continue to fully support our broader MS portfolio. In addition, we are ramping up our commercial preparations for aducanumab, which will create some upward pressure on SGNA. However, as always, we will continue to diligently manage our operating expenses to ensure we remain efficient across the organization. In Q3 of this year, our effective gap tax rate was approximately 25%, which was increased from approximately 12% in the third quarter of 2019.
GAAP diluted earnings per share in the third quarter was $4.46.
Decrease of 47% versus the prior year and non-GAAP diluted EPS was $8.84 a decrease of 4% versus the prior year.
We repurchased approximately 4.5 million shares in Q3 for a total value of approximately $1.3 billion a share repurchase program authorized in December of 2019 was completed as of September 30, 2020, and our board of directors has authorized a new $5 billion share repurchase program.
Michael R. McDonnell: This increase is primarily due to prior year favorability from Swiss tax reform as well as current year unfavorability primarily driven by non-cash deferred tax adjustments related to Tecfidera. For the third quarter of 2020, our effective non-GAAP tax rate was approximately 18%, an increase from approximately 16% in the third quarter of 2019. Third quarter gap net income was $702 million, and non-gap net income was $1.4 billion. Gap to lost earnings per share in the third quarter was $4.46.
In Q3, we generated approximately $1.2 billion in net cash flows from operations cash.
Capital expenditures in Q3 were $84 million and free cash flow was approximately $1.1 billion.
We ended the quarter with $4.6 billion in cash and marketable securities and $7.4 billion in debt.
Additionally, our $1 billion revolving credit facility was undrawn as of the out of the quarter.
Let me now provide an update to our full year guidance for 2020.
Our guidance was last updated in July and assumes no generic entry protect the Dara during.
During the third quarter, we began to experience the impact of generic entrants with more than 10, <unk> techs Adair generics approved at least six now in the market and discounted prices of approximately 90%.
Michael R. McDonnell: A decrease of 47% versus the prior year, and non-GAAP diluted EPS was $8.84, a decrease of 4% versus the prior year. We repurchased approximately 4.5 million shares in Q3 for a total value of approximately $1.3 billion. The share repurchase program authorized in December of 2019 was completed as of September 30, 2020, and our Board of Directors has authorized a new $5 billion share repurchase program. In Q3, we generated approximately $1.2 billion in net cash flows from operations. Capital expenditures in Q3 were $84 million, and free cash flow was approximately $1.1 billion.
Our guidance assumes significant erosion of tech the debt in the fourth quarter of 2020, the pace of which is difficult to predict.
As a result, we now expect full year revenue to be between approximately $13.2 billion to $13.4 billion. We.
We expect full year, Twentytwenty GAAP diluted EPS to be between $25.50 and $26.50 and non-GAAP diluted EPS to be between $32.50 and $33.50 of.
Of note. This range excludes the upfront payments associated with the Sangamo and Denali collaborations during the second and third quarters of 2020, respectively.
The upfront payment associated with the Q2 Sangamo transaction equates to roughly 65 cents per share.
Michael R. McDonnell: We ended the quarter with $4.6 billion in cash and marketable securities and $7.4 billion in debt. Additionally, our $1 billion revolving credit facility was undrawn as of the end of the quarter. Let me now provide an update to our full-year guidance for 2020. Our guidance was last updated in July and assumes no generic entry for Tecfidera. During the third quarter, we began to experience the impact of generic entrants, with more than 10 Tecfidera generics approved and at least 6 now on the market and discounted prices of approximately 90%. Our guidance assumes significant erosion of TechFedera in the fourth quarter of 2020, the pace of which is difficult to predict. As a result, we now expect full-year revenue to be between approximately $13.2 and $13.4 billion. We expect full-year 2020 GAAP diluted EPS to be between $25.50 and $26.50, and non-GAAP diluted EPS to be between $32.50 and $33.50.
It's important to note that this guidance does not include potential impacts from new acquisitions or large business development transactions as both have elements that are hard to predict this financial guidance also assumes that foreign exchange rates as of September 32020 remain in effect for the remainder of the year.
I'll now turn the call back over to Michel for his closing comments.
Thank you bye bye.
Biogen has remained focused on strong execution across our core business and then as SDMA and by you'll see me dolls, while continuing to advance our strategy of building a meeting franchise portfolio.
I want just to Haiti, a rate that was a commitment to maximizing returns to our shareholders and bringing you know that keeps up used to patients now and over the long term.
This requires that we continue to allocate capital if you simply if activity and Apple kit.
As we have demonstrated in the past we've always tried to have an optimal capital structure as well as aim for superior returns from investments we make.
Again, we are actively preparing for the IDE you can you map Advisory committee and a potential launch.
Unmet medical need and cost to society for designers are tremendous and Mam team.
[laughter], sorry, I must create it puts the burden of approximately 550 begins to us, but you're in the U.S. and the quotes for caring for and as I Miss station can be over how can you get into the house I Diamonds, you tried to many patients of the independents by the age of eight.
Michael R. McDonnell: Of note, this range excludes the upfront payments associated with the Sangamo and Denali collaborations during the second and third quarters of 2020, respectively. The upfront payment associated with the Q2 Sangamo transaction equates to roughly $0.65 per share. It's important to note that this guidance does not include potential impacts from new acquisitions or large business development transactions, as both have elements that are hard to predict. This financial guidance also assumes that foreign exchange rates as of September 30, 2020, remain in effect for the remainder of the year. I'll now turn the call back over to Michel for his closing comments. Biogen has remained focused on strong execution across our core business in MS, SMA, and biosimilars while continuing to advance our strategy of building a multi-franchise portfolio.
Approximately 75% of people I've ever disease, even nursing home I took the patient cost of approximately 100000 das bigger yep.
The approval of educating that would be an unprecedented milestone for patients their families and society at large and will represent an important short term and long term growth driver for the company.
Finally, we are focused on advancing our broader purpose as an organization as we entered by getting a science for the betterment of humanity and this includes doing the right thing for patients our employees the environment and the community while accelerating our efforts in diversity and inclusion.
All of which we believe continues to long term sustainable shareholder value.
Michael R. McDonnell: 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 from the investments we make. Again, we are actively preparing for the Adukanimab Advisory Committee and a potential launch. The unmet medical need and cost to society for Alzheimer's are tremendous and mounting. Alzheimer's creates a cost burden of approximately $550 billion per year in the US, and the cost of caring for an Alzheimer's patient can be over half a million dollars. Alzheimer's deprives many patients of their independence. By the age of 80, approximately 75% of people with Alzheimer's disease live in a nursing home at a per patient cost of approximately $100,000 per year.
These issues are old endeavor related for example, environmental issues as central to human has to that.
To that end I am incredibly proud of our recently launched 20, your 250 million that I heads. He climate has he lives in <unk>.
This includes a goal to eliminate I was cooking food innovation by 24 key end to be a catalyst for positive change by advancing the science around how pushing fuel impact human health and take action to promote climate and has a cookie.
Finally, I would like to thank our employees around the world. What did you say to making the positive impact of fiction Tonight, including ensuring access to other therapies. During these challenging times, we that we will open the floor for questions.
Thank you.
I 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 up you May press star one again to rejoin the queue.
Your first question comes from Terence Flynn with Goldman Sachs.
Michelle Bonazzos: The approval of EducatingMAD would be an unprecedented milestone for patients, their families, and society at large and will represent an important short-term and long-term growth driver for the company. Finally, 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 while accelerating our efforts in diversity and inclusion, all of which we believe contribute to long-term sustainable shareholder value. These issues are all interrelated. For example, environmental issues are central to human health.
Hi, good morning, Thanks for taking taking my question.
As you prepared for the AD com any notable new analyses or data points that we should expect to.
To hear about as you try to frame the risk benefit for the drug here and then congratulations on the a European filing anything notable in terms of similarities or differences here versus your discussions with the F.D.A. that you can call out on the European side. Thank you.
Hi, This is out we've done a lots of analysis, we've been doing that for more than a year in collaboration with Sta. We we're working exceptionally hard and the team is working exceptionally hard to prepare for the AD com and we're very excited about sharing our perspective on.
Michelle Bonazzos: To that end, I am incredibly proud of our recently launched 20-year, $250 million Healthy Climate, Healthy Lives initiative, which includes a goal to eliminate our fossil fuel emissions by 2040 and to be a catalyst for positive change by advancing the science around how fossil fuel impacts human health and economic action to promote climate and health equity. Finally, 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 this challenging time. With that, we will 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.
That that.
Yeah, I mean, you difference.
Rental revenue.
The E U we just filed after some formal meetings and we expect to hear back and start the engagement process.
And then in Japan, or we are just.
Just had a formal interactions and we'll be filing soon.
We will take our next question from Marc Goodman with SBB.
Hi, good morning questions really about expenses, you're about to lose $3 billion of tech for terrorists sales and I was just curious.
[noise] comes or not.
Restructuring plan.
Just significant cost cutting to help offset that I understand.
He is still there, but clearly there's a disconnect between the sales at those two.
Sales at those two.
And then just secondarily can you talk about any tax rate implications because it took for their sales going away. Thank you.
Operator: If you require any further follow-up, press star 1 again to rejoin. Your first question comes from Terence Flynn with Goldman Sachs. Hi, good morning.
So thanks for the good question, we got always obviously looking that to savings opportunity and how to begin even more efficient operation, mostly when we face to the potential don't suffer I'll stick to new wells.
Terence Flynn: Thanks for taking my questions. As you've prepared for the ADCOM, any notable new analyses or data points that we should expect to hear about as you try to frame the risk benefit for the drug here? And then congratulations on the European filing. Anything notable in terms of similarities or differences here versus your discussions with the FDA that you can call out on the European side? Thank you. Hi, this is Al.
Cheese, which is certainly a much of an impact we need to extract approximately 400 million from a infrastructure.
To be sure no and Seadrill the nation and we have in our rate of solutions in place you know that to simplify the back of fees and try to save additional resources you need you need obviously to understand that and we still have a it seeks blast BT.
Geoffrey Christopher Meacham: We've done lots of analysis. We've been doing that for more than a year in collaboration with FDA. We were working exceptionally hard, and the team is working exceptionally hard to prepare for the ADCOMM, and we're very excited about sharing our perspective on that day, and I'm with you. In the EU, we just filed after some formal meetings, and we expect to hear back and start the engagement process. And in Japan, we just had our formal interactions, and we'll be filing soon. We will take our next question from Marc Goodman with, Good morning. The question is really about expenses.
These nets, we Dennis.
The highly competitive environment, where we need to have some TV source you know that you find out with our leadership position, namely tea not that helpful. Now, but you signing <unk> demonstrating some good signs and we come back to eat so we need to do to stay on and continue to be sold to the launch of the new Ricky.
And obviously they use as you can imagine we use the learning from kobi on utilization or so to gain and.
If you shouldn't see but again, we need to continue to source the base business, we need to prepare for the launch of had you can not because we are optimistic and at the same time, we try really to save what we can.
Marc Harold Goodman: Unknown Executive, Ami Fadia, Adam Keeney, Chris Schott, Biogen Inc., And then just secondarily, can you talk about any tax? So thanks for the good question. We are always obviously looking at savings opportunities and how to be an even more efficient operation, mostly when we face the potential launch of tech in the US, which is certainly a material impact. We extracted approximately 400 million from our infrastructure in order to be a linear and simpler organization, and we have an array of measures in place in order to simplify the back office and try to save additional resources. Linearity is immaterial for now, but it's demonstrating some good signs, and we'll come back to it.
Yes, I'll just quickly add to that mark thanks, very much for the question Mike speaking I think just.
I think just to add to what Michelle was saying a little bit of color you know running at about 17%.
Revenue estimate we feel like it runs pretty efficiently as Michelle said, we are reallocating some some cost and resources to the ads academies launch an end to the sport of the temerity and obviously, we do need to continue to support the M.S. franchise, but I would just.
I would just point out that you know any any cost savings that we have you know we guided for only the fourth quarter were not guiding for 21 at this time, but.
But obviously you wouldn't see cost impacts around.
Around this until 2021, which we'll talk more about when we get to 2021.
Michelle Bonazzos: So we need to stay on and continue to fund the launch of Linearity, and obviously, there is Aducanimab. We use the learning from COVID and digitalization also to gain efficiency. But again, we need to continue to fund the base business. We need to prepare for the launch of Aducanimab because we are optimistic. And at the same time, we really try to save what we can.
On your question around the tax rate I think you were reacting to a comment in the prepared remarks, given the change in the cash flow profile and the profitability profile for Techfaith. There. There was a deferred tax adjustment that was required to be booked relating to evaluation allowance, which had a modest impact on the effective tax rate for the quarter.
Okay. That's helpful. So I'd have to add to what Mike said and that.
They see the rights to the buffer DTN X us if you remove Kentucky U.S. market and is growing and that's some countries that we are launching a few so we see continued to be sourced overhaul or you know seems to be done plus and that's franchise and also takes you there exists.
Michael R. McDonnell: Yeah, so I'll just quickly add to that, Marc. Thanks very much for the question, Mike speaking. I think just to add to what Michelle was saying, a little bit of color, you know, running at about 17% of revenue SG&A, we feel like it runs pretty efficiently.
We will take our next question from Matthew Harrison with Morgan Stanley.
Great. Good morning, Thanks for taking the question I guess as you guys think about the Advisory Committee and you think about potential path to approval. What do you think is the risk that the FDA may.
Michael R. McDonnell: As Michelle said, we are reallocating some costs and resources to the Adjacatamap launch and to the support of Vimerity. And obviously, we do need to continue to support the MS franchise. But I would just point out that, you know, any cost savings that we have, we've guided for only the fourth quarter. We're not guiding for 21 at this time.
Think about proving as you can imagine a certain sub group of patients where they think the risk benefit it is better compared to the overall patient population. If you could comment on that that would be helpful. And then Mike can you just comment on inventory trend in the quarter. Thanks.
Michael R. McDonnell: But obviously, you wouldn't see cost impacts around this until 2021, which we'll talk more about when we get to 2021. On your question around the tax rate, I think you were reacting to a comment in the prepared remarks. Given the change in the cash flow profile and the profitability profile for Tecfidera, there was a deferred tax adjustment that was required to be booked relating to the evaluation allowance, which had a modest impact on the effective tax rate for the quarter.
Hi, Matthew this is out we look the FDA has all the data we we continue to believe that as you can imagine.
Has a substantial evidence of efficacy if we didn't believe that we wouldn't have filed and we look forward to sharing all the data that the FDA Advisory committee, including a potential subgroups and it's in the FDA has hands at this point.
Yeah. This is Joe in terms of your question on inventory I would just say there wasn't a significant impact on the quarter and not something that we called out.
We will take our next question from Omar with Evercore ISI.
Michael R. McDonnell: So hopefully that's helpful. To add to what Mike said, Tecfidera is still above a billion XUS if we completely remove the US market, and it's growing. And there are some countries that we are launching Tecfidera. So we still continue to develop the overall, you know, 6 billion plus MS franchise and also Tecfidera XUS. We will take our next question from Matthew Harrison with Morgan. Okay. Good morning.
Hi, guys. Thanks for taking my question Michelle I know you were Super excited the day, you guys decided to file with the FDA I don't know if it fits the virtual instead this call today, but I'm not quite hearing that at least on the call for the filing.
Is there something he was raising which is different than F.D.L. <unk> I'd be curious to what you see on that Michelle and now I know when the data was presented there were several very important aspects of the data that werent showing and I think the assumption was there probably consistent with the overall analysis, but can you speak to whether you're expecting it to be able to focus on.
Matthew Harrison: Thanks for taking the question. I guess as you guys think about the advisory committee and you think about. Unknown Executive, Ami Fadia, Adam Keeney, Chris Schott, Biogen Inc., better compared to the overall population. If you could comment on that, that would be helpful. Mike, can you just comment on inventory trends in the quarter? Hi Matthew, this is Al.
The equal equal or carriers versus non carriers and can you remind us what the efficacy is consistent in those two groups as well as if we only looked at patients without ARIA. If you expect is the efficacy dealt that consistent with the overall conclusion.
Geoffrey Christopher Meacham: Look, the FDA has all the data. We continue to believe that adjucanumab has substantial evidence of efficacy. If we didn't believe that, we wouldn't have filed.
So let me take the first parts of your question Umer and so.
So we are equally excited about all the interactions with regulators older round. The worlds, having said that the U.S. a year when certain nutrients as a cascade order I think the datas, we had actually to refocus our team on the U.S.N.D. because we were approved by all the agencies who wanted to.
Geoffrey Christopher Meacham: And we look forward to sharing all the data at the FDA Advisory Committee, including potential subgroups. And it's in the FDA's hands at this point. And this is Joe.
Joe Marra: In terms of your question on inventory, I would just say, you know, it wasn't a significant batch in the quarter and not something that we called out. We will take our next question from Umer Raffat with Evercore ISD. Hi guys, thanks for taking my question. Michelle, I know you were super excited the day you guys decided to file with the FDA. I don't know if it's just the virtual nature of this call today, but I'm not quite hearing that, at least on the call about the EU filing. Is there something the EU is raising which is different than FDA? I'd be curious what you say on that, Michelle.
And while he does so she had the data so.
So I will not speak about China and older markets, Australia, Canada, Switzerland, It ticked up so.
Certainly the focus is on the U.S.A.D.A. The November six we are excited and we opportunistic and the than the others. We unfold the Metro New York City.
I'll tell you more on your on your question about carriers versus non carriers look I don't want to speculate as to what the FDA, but.
Umer Raffat: And Al, I know when the data was presented, there were several very important aspects of the data that weren't shown, and I think the assumption was they were probably consistent with the overall analysis. But can you speak to whether you're expecting FDA to focus on APOE4 carriers versus non-carriers? And can you remind us if the efficacy is consistent in those two groups? As well as, if we only looked at patients without ARIA, is the efficacy delta consistent with the overall conclusion?
I will ask the advisors at the Advisory Committee.
But if they go there were prepared were is we haven't shown our subgroup data yet we will at some point and for all I know it may come up at the Advisory Committee, but where we're eager to share our perspective on the data whatever comes up.
We will take our next question from Evan Seeker men with credit Suisse.
Hi, there. Thank you so much for taking the question. So one for Michael Nice to meet you on the phone so with the erosion of tech fit era, why did you opt to authorize an additional share repurchase program versus say allocating your capital elsewhere to maybe help grow revenues aside from educating about how do you plan on addressing this decline in revenue and earnings that were now.
Michelle Bonazzos: So let me take the first part of your question, Umer. We are equally excited about all the interactions with regulators all around the world. Having said that, the U.S. FDA will certainly influence, as a cascade, all the regulators. We had to refocus our team on the FDA because we were pulled by other agencies who wanted to meet and wanted us to share the data. So I will not speak about China and all the markets, Australia, Canada, Switzerland, et cetera.
Thank you.
Sure No I haven't not nice to meet you in <unk>. Thanks, very much for the question.
Biogen for a period of time now has been very active in allocating capital as Michelle mentioned in the prepared remarks.
Michelle Bonazzos: So certainly, the focus is on the U.S. FDA, on November 6th. We are excited and we are optimistic, and then the others will unfold naturally, hopefully. I don't want to speculate as to what the FDA will ask the advisors at the advisory committee, but if they go there, we're prepared. We haven't shown our subgroup data yet.
In the last four years 20 transactions I'm approaching $5 billion and obviously the company has returned significant capital to shareholders in the form of share buybacks and we expect both of those activities are going to continue obviously, we're going to continue to be active on the BD front as the company has been before.
And you know notwithstanding the the situation with tech for Darryl.
Geoffrey Christopher Meacham: We will at some point, and for all I know, it may come up at the advisory committee, but we're eager to share our perspective on the data, whatever comes up. We will take our next question from Evan Seigerman with Credit. Hi there, thank you so much for taking the questions. So one for Michael, nice to meet you on the phone.
We've got $4.6 billion of cash on hand as of the end of September a modest amount of debt net debt I think $2.8 billion. We've got I'm still very significant cash flow and a a very pristine balance sheet and we intend to utilize that for both BD and share repurchases and and you know the the logic of the show.
Every purchase just completely aligns with that.
Okay, great. Thank you. So we we do remain very active on the on M.D. and the the organization can continue to do both.
Return shoulder to the and capital to the show those and also adds to the business momentum and we are prepared for both working very hard on that.
Evan Seigerman: So with the erosion of the TechFed era, why did you opt to authorize an additional share repurchase program versus, say, allocating your capital elsewhere to maybe help grow revenue? Aside from education, how do you plan on addressing this decline in revenue and earnings that we're now seeing? Sure, no, Evan. Nice to meet you and thanks very much for the question.
Great. Thank you.
We will take our next question from Phil NATO with Cowen and company.
Good morning, Thanks for taking my question, how one for you I'm I'm curious.
You've been asked a few times about the outcome.
Kinda Dodge the questions about your argument is gonna be I'm curious if you could maybe just give us a brief preview.
What the key elements or other argument that had a kind of Matt has a positive benefit risk what parts of the data where you highlight and then on the risk side.
Michael R. McDonnell: Look, you know, Biogen for a period of time now has been very active in allocating capital. As Michelle mentioned in her prepared remarks, just in the last four years, 20 transactions, approaching $5 billion. And obviously, the company has returned significant capital to shareholders in the form of share buybacks, and we expect both of those activities are going to continue. Obviously, we're going to continue to be active on the BD front as the company has been before. And, you know, notwithstanding the situation with TechFedera, we've got $4.6 billion of cash on hand as of the end of September, a modest amount of debt, net debt, I think $2.8 billion. We've still got a very significant cash flow and a very pristine balance sheet.
Due to the area.
And then just a kind of a follow up question to that it is two weeks before we expect to see the briefing documents released publicly has his budget, we see them yet thanks.
So you know look our argument rests on the fact that we have a robustly positive study in emerge positive on pre specified primary and all secondary endpoints.
Oh, we have a supportive study in the phase one B trial, which was published in nature. A few years ago and then we have engaged and we believe we understand why engaged with a negative study and deepen our belief is that it doesn't detract from the positive study and then.
And in terms of the risks the main risk is our area. We believe its manageable that we've learned how to deal with it within MRI monitoring with tight ration and so you know we believe the benefit risk.
Worthy of approval, if we didn't think that we wouldn't have filed.
And so that's and in terms of the briefing book, we're not going to comment on on on on briefing book, a it'll as stated in the FDA Register will be made publicly available two days prior to the actual advisory Committee meeting.
Michelle Bonazzos: And we intend to utilize that for both BD and share repurchases. And, you know, the logic of the share repurchase just completely aligns with that. Okay, great.
We will take our next question from Michael Yee with Jefferies.
Phil Nadeau: Thank you. We do remain, Evan, very active on VD, and the organization can continue to do both, return capital to the shareholders and also add to the business momentum, and we are prepared for both. We are working very hard on that.
Hi, Thanks for the question I'm just following up on <unk> can you just comment about the language on how the FDA May plan to act early well what does that mean, a chat way earlier and just maybe you could keep the traction that you just made national color on that and if you ever while early but do you actually.
Geoffrey Christopher Meacham: Great, thank you. We will take our next question from Phil Nadeau with Cowan. Good morning. Thanks for taking my question. I have one for you.
Phil Nadeau: I'm curious. You've been asked a few times about the adcom, but you kind of dodged the questions of what your argument was going to be. I'm curious if you could maybe just give us a brief preview. What are the key elements of your argument that Adekanamab has a positive benefit-risk profile? What parts of the data will you highlight? And then, on the risk side, how will you deal with the area? And then just kind of a follow-up question to that: it is two weeks before we expect to see the briefing documents released publicly. Has Biogen received them? So, you know, look, our argument rests on the fact that we have a robustly positive study in eMERGE, positive on pre-specified primary and all secondary endpoints. We have a supported study in the Phase 1B trial, which was published in Nature a few years ago.
Okay ready to launch literally any day that actually happened and if it's not the case any question that way can you catch rightsized to which way expenses might be going because I think he spent a lot of preparing for the SREC shopped domestic Patricia and would that need to be addressed it just maybe some color there. Thank you so much.
I'll take the first part Michael in terms of acting early the FDA has had the data since last June our first tight right. After our first type C meeting, we sent them all the primary data.
That could be one reason why they said that they could act early and.
And we see the advisory committee scheduled pretty early relative to the timeframe that they have until the PDUFA date of early March.
Uh huh.
Concerning the the launch readiness. The short answer is absolutely. Yes. We have continued we have increased the need you can engagement, we sense. If akita's you have engaged we'd say, yes, we are working on the value proposition and the potential price, we are making progress the visa croissant.
Geoffrey Christopher Meacham: And then we have Engage, and we believe we understand why Engage was a negative study, and our belief is that it doesn't detract from the positive study. And in terms of the risks, the main risk is ARIA. But we believe it's manageable, that we've learned how to deal with it, with MRI monitoring, and titration. And so, you know, we believe the benefit-risk is worthy of approval. If we didn't think that, we wouldn't have filed. And so that's – and in terms of the briefing book, we're not going to comment on that briefing book.
A team working on the site trade units they are willing to meet them to engage despite despite colleagues. We have certainly enhances EG does that they'd be can you for which the baseline was already very strong patient engagement inpatient services has been increased because we anticipate many many requests core advise.
Patients, we have a very rigorous approach to the potential launch by year specializing focusing first on the most important treatment centers, especially at least and then going to the broader population and obviously engaging with the Medicare and again the burden of these easy so high.
Geoffrey Christopher Meacham: As stated in the FDA register, it will be made publicly available two days prior to the actual advisory committee meeting. We will take our next question from Michael Yee with Jeff. Thanks for the question. Just following up, can you just comment on the language around how the FDA may plan to act early? What does that mean? Is that way earlier?
Today. These are high interest from all the parties, we need even if we are the only one BBB plus we kill somehow we cheese that we choose a which is a challenge, but the baby pleased with the progress we'd be ready.
I guess, the last fire, which just expenses.
Yeah, I mean look I think hopefully you know our optimism is clear and that's an area. We're planning toward is a successful launch of as you can imagine the hopefully unlikely event that we don't have approval of course, we would have an obligation to look at our our cost base.
Michael J. Yee: And just maybe, you keep emphasizing that, so just maybe add some color to that. And if it was early, would you actually be ready to launch literally any day if that actually happened? And if it's not the case that it goes that way, can you just right-size which way the expenses would be going? Because I think you spent a lot of time preparing for this, which is optimistic, but just would that need to be adjusted? Just maybe some color there.
Thank you guys very helpful.
We will take our next question from Cory Kasimov with JP Morgan.
Great. Good morning, guys. Thanks for taking the question I just wanted to follow up on something I'm. Michelle that you just mentioned around pricing I acknowledge upfront, putting a giant cart before the horse, but it's as you can imagine is approved can you just talk about your latest thoughts on how to potentially to price this out to best maximize the product's potential and accessibility.
Michelle Bonazzos: Thank you so much. I'll take the first part, Michael. In terms of acting early, the FDA has had the data since last June, right after our first type C meeting. We sent them all the primary data. That could be one reason why they said that they could act early.
And since that's what seems to be asking to just a housekeeping for Michael with.
With Spinraza sales down 10% this quarter I mean, you've alluded to both competition as well as kind of the continued effects of Cove is there any way to delineate that a little bit and talk about roughly speaking what to do to each one.
Michelle Bonazzos: And we see that the advisory committee has been scheduled pretty early relative to the timeframe that they have until the PDUFA date of early March. Concerning launch readiness, the short answer is absolutely yes. We have increased medical engagement with scientific leaders. We have engaged with payers. We are working on the value proposition and the potential price, and we are making progress. There is a cross-functional team working on site readiness, and they are willing to meet and engage despite COVID. We have certainly enhanced the digital capability for which the baseline was already very strong.
So we are also making progress on the potential price for educating that shouldn't be approved it's too premature and but we are engaging brody we'd come up we couldn't use to ice or an older advisors.
I eluded to into the into the note earlier the cost to society. So high we are working on certain assessing very clearly the clinical meaningfulness and what would be the value that you can add we provide to the different set of customers starting by the patients do can you give us the thing is.
And all aspects related to these to value creation that dependent not we'd bring not only the one that over the entire life of the product even beyond potentially the patent when the patent expires. So it's too early we come back to that and do you have to keep these quick.
Michelle Bonazzos: Patient engagement and patient services have been increased because we anticipate many, many requests, calls, and advice from patients. We have a very rigorous approach to the potential launch by focusing first on the most important treatment centers, the specialists, and then going to the broader population. Obviously, engaging with Medicare, and again, the burden of the disease is so high that there is a high level of interest from all the parties we meet, even if we are the only one building the infrastructure somehow, which is a challenge. But I am very pleased with the progress. We'll be ready.
As shown that we've been lucky enough to I would say serious focus and dedication and the device from all of those.
So Cory on the second part of your question I'll try to give you. Some data points that are hopefully helpful and just kind of speaking in year over year terms.
So globally Spinraza was down 10% year over year and you'll see in some of the charts that we put up that patients are actually up 21%.
Unknown Executive: Unknown Executive, Ami Fadia, Chris Schott, Biogen Inc., Thank you guys for your help. We will take our next question from Corey Kazimoff with, "Good morning, guys."
Year over year, and the dynamics that factor into this are a few things.
A few things one is product dosing dynamics, you know, we have fewer loading doses versus maintenance doses as the product matures.
Corey Kazimoff: Thanks for taking the question. I just wanted to follow up on something, Michelle, that you just mentioned regarding pricing. I'll acknowledge up front that it's putting a giant cart before the horse, but if EducandyMap is approved, can you just talk about your latest thoughts on how to potentially price this to best maximize the product's potential and accessibility? And since everyone seems to be asking, too, just housekeeping for Michael, with Spinraza sales down 10% this quarter, you alluded to both competition as well as kind of the continued effects of COVI Is there any way to delineate that a little bit and talk about, roughly speaking, what to do with each one?
Secondly, there are covert impacts we can't precisely tell you what that number is it's kind of hard to tease out but there are certainly when we see fewer new patient adds are going through loading doses and some dosing delays. We know that part of the reason is related to covidien patients not getting into it to get those treatments.
There's some country mix.
In the in the mix here, sorry, so to speak.
And some of the patient growth that we've had is coming from countries, where the prices are lower and lastly, there is competition from so jasmine everybody. So those are kind of.
Those are kind of all in the mix to precisely say what they call. The pieces is not something that we can completely tease out we know it is in the mix and hopefully those metrics that I gave you were somewhat helpful.
Yeah definitely thank you.
Thank you.
We will take our next question from Ronny Gal Bernstein.
Michelle Bonazzos: So, we are also making progress on the potential price for aducanumab, should it be approved. It's still premature, but we are engaging broadly with pharmacoeconomists, ICER, and other advisors. As I alluded to in the note earlier, the cost to society is so high. We are working on assessing very clearly the clinical meaningfulness and what will be the value that aducanumab will provide to the different sets of customers, starting with the patients, the caregivers, the payers, and all aspects related to this value creation that aducanumab will bring, not only in year one but over the entire life of the product, even beyond, potentially It's too early; we'll come back to that.
Hi, congratulations thank you for the call.
One just a clarification on and again you have that you just stick on the phone I did that.
Basically on the cost structure that I look you know we might have to take a look at our cost structure, but we will wait until we know more by the kinda not before we decide how to do this I'm just trying to this is this is gone the message as we think about the cost cuts in 2021.
And second to stay on the estimate.
Can you just give us a feel for your share of new starts in the U.S. and internationally. Just so we can kind of have a model forward how them.
How the market looks like.
Sure. So Ronny it's Mike speaking so you know I'm on your interpretation on the cost.
Michael R. McDonnell: We are taking this question with a lot of, I would say, serious focus and dedication and advice from others. So, Corey, on the second part of your question, I'll try to give you some data points that are hopefully helpful and just kind of speaking in year-over-year terms. So globally, Spinraza was down 10% year-over-year, and you'll see in some of the charts that we put up that patients are actually up 21% year-over-year. And the dynamics that factor into this are a few things. One is product dosing dynamics. We have fewer loading doses versus maintenance doses as the product matures. Secondly, there are COVID impacts. We can't precisely tell you what that number is. It's kind of hard to tease out, but certainly, when we see fewer new patient ads going through loading doses and some dosing delays, we know that part of the reason is related to COVID and patients not getting in to get those treatments.
You know as we've said, we're we're we're gearing up for a launch of ads Academy that does add some some pressure to S.G. anyway and that is something that we're very focused on obviously getting right. We have reallocated some research.
Resources as I said in the prepared remarks from a texture there too as you can imagine as well as the support of the merits of we are going to continue to support the M.S. platform as Michelle said, we have over a billion dollar franchise outside of the U.S. and tech that area, which is important to remember.
And so that's kind of the state of play in terms of the fourth quarter that we've guided to you today.
And you know, we'll have more to say about all of our financial metrics as we get into 2021.
And provide presumably guidance for next year at that time.
Yeah, right and then the second part of your question I mean, I don't think we've gotten to that level of detail in terms of kind of shares in new starts and whatnot, but if you want I can I add a bit more color on what we see tens off market deals I mean <unk>.
Michael R. McDonnell: There's some country mix in the mix here, so to speak, and some of the patient growth that we've had is coming from countries where the prices are lower. And lastly, there is competition from Phil Gentzman at RISD. So those are kind of all in the mix to precisely say what the COVID piece is. It's not something that we can completely tease out.
I can see the U.S. lead a recent launch.
If you combine that with the current environment certainly generating some switch from the from Spinraza nbcs understandable because of the perceived convenience.
And you know, but to the centerpiece data is showing any cementation and mostly because of the oh staggered ducks potentially and the size of the UN seeding that may impact if he can see why the weight of the kids increases and patients and physicians to start to be aware of that.
Michael R. McDonnell: We know it is in the mix, and hopefully those metrics that I gave you are somewhat helpful. Yeah, definitely. Thank you. Thank you. We will take our next question from Ronnie Gao with Bernie. Congratulations.
Ronnie Gao: Thank you for the call. I wanted some clarification. And again, nice meeting you as an NEC co-founder. The best is basically on the cost structure. Look, you know, we might have to take a look at our cost structure, but we will wait until we know the outcome of I do Canada before we decide how to do this. I'm just clarifying.
But nevertheless at the time of launch you know patients I trusted value potential ordinary vacation, but it's not that easy 265 times a year, we can lead to read you the challenging dosing the C suite times that you're on the unsecured indeed being sure that you get to those so we believe that based on that.
Michael R. McDonnell: Can you give us a feel for your share of new starts in the U.S. and internationally? Sure. So, Ronnie, it's Mike speaking.
That that to have an old do real world evidence from the influence we seem to might seek to symptomatic I don't its at the end of the day safety and efficacy profile. If he can see profile, mostly we prevailed should prevail. That's why we remain reasonably optimistic about the spinraza once this way but.
Michael R. McDonnell: So, you know, on your interpretation of the cost, you know, as we've said, we're gearing up for a launch of Aducanumab that does add some pressure to SG&A. And that is something that we're very focused on, obviously, getting right. We have reallocated some resources, as I said in the prepared remarks, from Tecradera to Aducanumab, as well as the support of Pumerity. We are going to continue to support the MS firm. As Michelle said, we have over a billion dollar franchise outside of the U.S. in Tecradera, which is important to remember. And so that's kind of the state of play in terms of the fourth quarter that we've guided to today.
The answer is yes, and you should be behind us.
Okay. Thank you.
We will take our next question from Jeff Needham with Bank of America.
Hey, guys. Thanks for the question I just had a couple of quick ones.
Michelle on the chance of the panel isn't favorable or it doesn't approve what do you think could be some of the changes to the strategy. If it's more aggressive BD you know does the $5 billion buyback announced today preclude.
Potential for doing a larger more transformational deal.
And then just a quick follow up on Spinraza can you speak directionally how much of that.
Unknown Executive: And, you know, we'll have more to say about all of our financial metrics as we get into 2021 and provide, presumably, guidance for next year at that time. Yeah, Ronny, on the second part of your question, I don't think we've gotten to that level of detail in terms of kind of shares and new starts and whatnot. But if you want, I can add a bit more color on what we see in terms of market dynamics, at least in the US with a RISD launch. RISD combined with the COVID environment is certainly generating some switch from Spinoza. And this is understandable because of the perceived convenience.
How much of the switch dynamic what's in play in the U.S. this quarter and would that be an indicator for the bigger a U.S. market. Thank you very much.
So it just sun to stuff on Spinraza, we saw approximately 200 patients are not mistaken mistake.
You mean switched to a to a to the new launches. He leaves. The that's again, we are confident that overtime spin revenue to remain the foundation of that before the treatment of as they may come.
Concerning the the first question on the you know what do you think about this strategy as well I would like to stop they remain Inc.
Yes, I see that we remain optimistic about the potential launch of you.
And and a and D. She's the underlying.
Unknown Executive: The SenFish data is clearly showing some limitations, mostly because of the off-target tox potentially and the 5mg ceiling that may impact efficacy while the weight of the kids increases, and patients and physicians should start to be aware of that. Nevertheless, at the time of launch, patients are attracted by potential oral medication, but it's not that easy to run 65 times a year with challenging dosing versus 3 times a year only and being sure that you get the dose. So we believe that based on the data that we have and all the real-world evidence from infants pre-symptomatic to symptomatic adults, at the end of the day, safety and efficacy profile, That's why we remain reasonably optimistic about Spinraza once this wave of enthusiasm is a bit behind us. Great, thank you.
Underlying assumption, but nevertheless, I do fans with getting a very strong position. This should be very profitable. We have a deep pipeline, we have a strong balance sheets and there we have a large portfolio in CNS and a d. should enable long term growth and value creation.
So the prospects and that's something to be fine, but each and every event that they would be settings affected UK stuff I do failing we have a pipeline we have opportunity in all studies in stroke, you Deuce in a less and that you've seen us we have the BG deal. We did then you have the rest of the portfolio in AG.
Does she position in all of these you know how T.D.C. here and we have all the whole set teekay <unk> assets Eightk filed or in phase three.
And we have the entire portfolio, we lifecycle management opportunities and as I said I believe that if I may is been lines that would remain to some additional therapy. So because you see playing we'd be there all the time as discussed by year by Mike.
Geoff Meacham: We will take our next question from Geoff Meacham with Bank of America. Hey guys, thanks for the questions. I just had a couple of quick ones.
Yeah, I think the other point that I would just add is you know you mentioned you asked whether the the share repurchase authorization for class B D and the answer is we said before as it it doesn't.
Michelle Bonazzos: Michelle, on the chance that the panel isn't favorable or FDA doesn't approve, what do you think could be some of the changes to the strategy? If it's more aggressive BD, you know, does the $5 billion buyback announced today preclude the potential for doing a larger, more transformational deal? And then just a quick follow-up on Spinraza; just can you speak directionally to how much of the switch dynamic was in play in the US this quarter and would that be an indicator for the bigger OUS market? Thank you very much.
We will continue to do both and I would just remind that the.
The authorization is very flexible there's no time stamp on it. So we'll continue to do both and be active and we have a balance sheet. That's in a great position, which we're pleased about.
Okay. Thank you.
Thank you.
We will take our next question from Sumant Kulkarni with Canaccord.
Mike Thanks for taking the question if that came out of the pool, you expect a form of risk evaluation and mitigation strategy program to be put in place and we know you said you're ready to launch on day, one but what.
Michelle Bonazzos: So just to start on Spinraza, we saw approximately 200 patients were not mistaken, mistakenly being switched to the new launch of Averis D. But again, we are confident that over time, Spinraza will remain the foundational therapy for the treatment of SMA. Concerning the first question on, you know, what do you think about the strategy if, well, I would like to start by remaining, you know, reassessing that we remain optimistic about the potential launch of ADEW, and this is the underlying assumption. But nevertheless, if ADEW fails, we are still in a very strong position, we will still be very profitable, we have a deep pipeline, we have a strong balance sheet, and we have a large portfolio in CNS, and this should enable long-term growth and value creation. So the prospects are not solely defined by the binary event, but they will certainly be affected in the case of ADEW failing.
Looking for stuff to it on the burden caused by potentially guns program.
This is out.
With respect to a Rems program you know it's hard to say at this point, we're still in the review process I would say that the that we believe that the risk of ARIA is is manageable and the community has learned how to manage this risk over the years.
Whether that requires the rems or not there is up to the FDA.
Thank you Manny can you repeat that the other part of the question for US if you don't mind.
Just about the infrastructure around the burden caused by a potential programming that's ready to go in case, you need to have one case.
Well, we've done that before we know how to do rems programs.
Whatever they may be and so we'd be ready for that yes, including the education piece, which is typically one of the most important aspects of rems programs.
Got it thank you.
We will take our next question from.
Jay Olson.
Right.
Hi, Thank you for taking the question I'd like to see it scares and asked about Parkinson's disease.
Michelle Bonazzos: We have a pipeline, we have opportunities in OFTA, in Stroke, in Lupus, in ALS, and biosignals. We have the BD deal with Denali. We have the rest of the portfolio in ADE. The leadership position in neurodegenerative disease is still here, and we have overhauled 30 clinical assets, 8 in field or in phase 3. And we have the entire portfolio with life cycle management opportunities. And, as I said, I believe that SMA, Spinoza, will remain the foundational therapy. So the COSI discipline will be there all the time, as discussed by my colleagues. Yeah, I think the other point that I would just add is, you know, you mentioned that you asked whether the share repurchase authorization precludes BD. And the answer, as you said before, is it doesn't.
As the leader in neuro degeneration could you share your vision for the future treatment of Parkinson's disease, where you have an alpha synuclein anti body and there's recently been signals of efficacy from CNN Roche and then you also have your butt to program with Denali and then there are several gene therapies in development and competitors. So.
Which of these approaches do you think is most promising and where does biogen put into the competitive landscape. Thank you.
Yes. Thank you very much. So we were very excited about the potential in Parkinson's disease. As you pointed out the protein erosion antibody looked like there was some efficacy in the parts two and three I believe of the Pdrs score.
With the additional support from digital measures and some imaging outcome measures that was presented at the movement disorder Society meeting about a month or so ago.
Michael R. McDonnell: We will continue to do both. And I would just remind you that the authorization is very flexible; there's no timestamp on it. So we'll continue to do both and be active. And we have a balance sheet that's in a great position, which we're pleased about. Thank you. Thank you. We will take...
And we have our own alpha Synuclein antibody, it's different in the sense that it's a more specific for aggregated forms of alpha synuclein, but there and where you expect to read out on that in the coming months.
Unknown Caller: Thanks for taking my question. If Adekanamab is approved, do you expect a formal risk evaluation and mitigation strategy program to be put in place? And we know you said you were ready to launch on day one, but what about the infrastructure around the burden caused by a potential REMS program? This is Al.
We also have antisense oligonucleotides programs directed against Alpha Synuclein.
You pointed out the work two inhibitor, we have Oh, the lead program areas. The Denali Onefive lung program, an oral small molecule or two inhibitor.
And you know that could work not just in more patients with work to mutations, but also there's ample evidence of lysosomal HEICO function and other cases of a P.D. even patients that don't have worked to mutation.
Geoffrey Christopher Meacham: With respect to the REMS program, you know, it's hard to say at this point. We're still in the review process. I would say that we believe that the risk of ARIA is manageable, and the community has learned how to manage this risk over the years. Whether that requires a REMS or not is up to the FDA. Thank you.
Mutations and so a good potential there that it could work in a in a broad range of Parkinsons patients and then as you pointed out and other lysosomal gene arguably is a GBA patients who are homozygous for for GBA have ago chaise disease, a lysosomal storage disease, those who are heterozygous.
Unknown Caller: Maybe you could repeat that, the other part of the question for us, if you don't mind. Just about the infrastructure around the burden caused by a potential REMS program. Is that ready to go in case you need to have one in place?
Goods have increased risk.
Geoffrey Christopher Meacham: Well, we've done that before. We know how to do REMS programs, whatever they may be. And so we'd be ready for that. Yes, including the education piece, which is typically one of the most important aspects of a REMS program.
Increased risk of Parkinson's disease, and so where where we have a preclinical programs directed against that as well and as I said, though we have the ability to license or two programs with the transport vehicle program, but also pointed out that earlier. This year, we did a deal with Sangamo, which includes not only.
Unknown Caller: Got it, thank you. We will take our next question from Jay Olson. Hi, thank you for taking the question. I'd like to shift gears and ask about Parkinson's disease. As a leader in neurodegeneration, could you share your vision for the future treatment of Parkinson's disease where you have an alpha-synuclein antibody, and there have recently been signals of efficacy from Profina and Roche, and then you also have your Look2 program with Denali, and then there are several gene therapies in development with competitors. So which of these approaches do you think is most promising, and where does Biogen fit into the competitive landscape? Thank you. Yeah, thank you very much.
Opportunities.
Gene therapy programs in Alzheimer's disease, but also parkinsons disease, one of our lead programs. There is a a gene therapy program on Alpha Synuclein. So so I think there's a there's a broad range I think there's a lot of very good validated targets validated by human genetics and by clinical Pathlogic data in humans.
And we have multiple modalities gene therapy small molecules.
Well as antisense oligonucleotides at our disposal.
Thank you I appreciate all the questions, we probably have time for about one month.
And we will take our next question from Brian Abrahams with RBC capital markets.
Hey, guys. Thanks, so much for taking my question. So you touched on some of the additional regulatory meetings held outside the U.S. and at Academy I'm curious on your feedback from Japan, specifically and in particular the role of the Phase. One two study that you had conducted there and whether you see potential for actually that's regulators such as those in Japan to Act early and then I mean just for.
Geoffrey Christopher Meacham: So we were very excited about the potential in Parkinson's disease. As you pointed out, the protheno-Roche antibody looked like there was some efficacy in parts two and three, I believe, of the UPDRS score, with additional support from digital measures and some imaging outcome measures as presented at the Movement Disorder Society meeting about a month or so ago. One of our lead programs there is a gene therapy program on alpha-synuclein, so I think there's a broad range.
Quickly on the unless franchise you've got several next generation agents like overnight one window seven another six one but they're all relatively early would probably come on line. After additional exclusivity losses. So just wondering how you're thinking about lifecycle. There whether you have a predilection for flexing down spend long term until these come to fruition or thinking about augmenting the mid stage and its portfolio to whether it's a commercial.
Geoffrey Christopher Meacham: I think there are a lot of very good validated targets validated by human genetics and by clinical pathologic data in humans. And we have multiple modalities, gene therapy, small molecules, as well as antisense oligonucleotides, at our disposal. We appreciate all the questions. We probably have time for about one more.
Structure in place thanks.
So Brian I think with respect to X U.S. filings I mean, as Michelle said, we're equally optimistic about about filings outside of the United States. We're just in the <unk> are there just aren't as advanced in terms of the procedure. You know, we just filed in May and we haven't even filed yet in Japan and.
Brian Abrahams: We will take our next question from Brian Abrahams with RBC Capital. Hey guys, thanks so much for taking my question. So, you touched on some of the additional regulatory meetings you've held outside the U.S. and at ICANN. I'm curious about your feedback from Japan specifically, in particular the role of the Phase 1-2 study that you had conducted there and whether you see potential for ex-U.S. regulators such as those in Japan to act early. And then, just really quickly, on the MS franchise, you've got several next-generation agents like 091, 107, and 061, but they're all relatively early and would probably come online after additional exclusivity losses. So, just wondering how you're thinking about the life cycle there, whether you have a predilection for flexing down, spending long term until these come to fruition, or thinking about augmenting the mid-stage MS portfolio to leverage the commercial infrastructure you have in place. Thanks.
So we're eager to start the regulatory procedures and as Michelle said were equally optimistic on the second part, but yeah on the lifecycle management up and as you know we've never been that to reaching tens of can you could pull common advancements you know and I spoke to you and bite the early by the way the BK and older.
Or the opportunities we have to develop or could they love some of our products and we have less second them and I've got to booking TV. They said really the Yaghi. We then said Q I've onex in the label degree key I and so we have plenty of opportunities to create marketing events and as you saw despite.
Potential launch of a high FICO C product that will affect you mean that they'd be tons of the class becomes the segment becomes very crowded tysabri continues to do very well because each so they were documented and when I appreciated by the patients and the physicians. So we are confident in the rest of the portfolio I would say beyond the challenging.
Geoffrey Christopher Meacham: So Brian, with respect to ex-U.S. filings, I mean, as Michelle said, we're equally optimistic about filings outside of the United States. We're just going to—we just aren't as advanced in terms of the procedure. You know, we just filed in EMA. We haven't even filed yet in Japan.
Situation, we are facing we the stake in the U.S. babies in anti your franchise beyond these have been specific case and the commitment of the company beyond RMS for any nation over the long term. So biogen continues to see both Ns lack of the day one.
Unknown Executive: And so we're eager to start the regulatory procedures, and as Michelle said, we're equally optimistic. On the second part— Yeah, on the lifecycle management of MS, you know, we've never been that rich in terms of clinical programs and advancements in our MS portfolio and pipeline, the early pipeline with the BTK, and all the opportunities we have to develop or co-develop some of our products. And we have lifecycle management opportunities with Tysabri, with the EID, with the CEPQ, Avonex, a new label, Plegriti, IM. So we have plenty of opportunities to create market events. And as you saw, despite the potential launch of a high-efficacy product of Acumumab that becomes—the class becomes—the segment becomes very crowded, Tysabri continues to do very well because it's very well-documented and well-appreciated by patients and physicians. So we are confident in the rest of the portfolio. I would say beyond the challenging situation we are facing with the tech in the U.S., there is an entire franchise beyond this very specific case and the commitment of the company beyond our MS to a nation over the long term. So Biogen continues to support MS patients like day one.
[noise] [noise]. So thank you all for your attention exciting time at Biogen and we are all looking forwards for early November for more news from the outcome and Theyre looking good for what they can get the company to the next step after these events. Thank you or.
Have a good day.
Ladies and gentlemen, this concludes today's call and we thank you for your participation you may now disconnect.
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Michelle Bonazzos: So thank you all for your attention; it is an exciting time at Biogen, and we are all looking forward to early November for more news from Atcom and looking forward to taking the company to the next step after this event. Thank you all, have a good day. And ladies and gentlemen, this concludes today's call, and we thank you for your participation. You may now disconnect. ,,,,,,, Copyright 2019 IFA Productions. All rights reserved. Copyright Australian Broadcasting Corporation.
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