Biogen Inc. is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for serious neurological and neurodegenerative diseases, operating as a single segment company . The company offers a range of products, including treatments for multiple sclerosis (MS), rare diseases, and biosimilars . Biogen also engages in collaborations and partnerships to expand its pipeline and market presence, such as with Eisai for LEQEMBI and Sage Therapeutics for ZURZUVAE .
- Multiple Sclerosis (MS) Treatments - Provides a comprehensive suite of therapies for MS, including TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI, and FAMPYRA.
- Rare Disease Treatments - Offers specialized treatments for rare diseases, featuring products like SPINRAZA, QALSODY, and SKYCLARYS.
- Biosimilars - Develops and markets biosimilar products, including BENEPALI, IMRALDI, FLIXABI, and BYOOVIZ.
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What went well
- Biogen is transforming passive capital into active growth, notably through the acquisition of HI-Bio, which is expected to drive shareholder value and enhance the R&D portfolio. ,
- New product launches are performing ahead of expectations, with LEQEMBI showing strong results not only in the U.S. but also in Japan and China, indicating a promising future for the company's Alzheimer's franchise. ,
- Cost reduction initiatives are exceeding goals, leading to improved margins and significant EPS growth, positioning the company for sustainable growth from 2025 to 2030. ,
What went wrong
- Biogen faces significant competitive threats to its Multiple Sclerosis (MS) franchise, including potential biosimilars for TYSABRI and an important patent litigation for TECFIDERA in Europe, with market exclusivity expiring in February, which could negatively impact revenues.
- LEQEMBI received a negative opinion from the EMA, casting doubt on its approval in the EU and potentially limiting its global market potential.
- Concerns among neurologists and Alzheimer's specialists about LEQEMBI's risk-benefit and cost-benefit ratios, and questioning of the amyloid hypothesis, may hinder wider adoption of the drug.
Q&A Summary
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Earnings Growth Outlook
Q: Is 2023 the earnings trough; what ensures growth ahead?
A: Michael McDonnell affirmed that Biogen aims for sustainable top and bottom-line growth. The company is pleased with the 2024 guidance, raising non-GAAP EPS growth to 9% at the midpoint ( ). He highlighted the stabilizing top line and the focus on cost savings programs that improve operating performance and free up capital for growth initiatives ( ). Biogen is confident that 2023 was the trough year and is focused on new product launches and the durability of the MS franchise to drive growth ( ). -
LEQEMBI EMA Decision
Q: Will you appeal the EMA's negative opinion on LEQEMBI?
A: Priya Singhal expressed disappointment with the EMA's negative opinion on LEQEMBI but affirmed plans to request a reexamination ( ). She emphasized that they believe in LEQEMBI's favorable benefit-risk profile, which has been approved in major regions like the United States, China, and Japan ( ). The reexamination process involves submitting additional data, including long-term and real-world evidence, to address the EMA's concerns, aiming for a potentially faster outcome than the original application ( ). -
Business Development Strategy
Q: What's your appetite for large acquisitions like Reata?
A: CEO Chris Viehbacher stated that Biogen is open to acquisitions similar to Reata but is disciplined and not desperate to do deals ( ). The focus is on areas where Biogen has strong capabilities, such as immunology and rare diseases, avoiding competitive auctions to prevent overpaying ( ). He highlighted that Biogen's size allows it to consider assets that may be too small for larger companies but significant for Biogen, aiming to create shareholder value through smart capital deployment ( ). -
LEQEMBI Subcutaneous Dosing
Q: Any updates on LEQEMBI subcutaneous dosing option?
A: Priya Singhal reported that they continue to work on the subcutaneous formulation of LEQEMBI, with a rolling submission in place and a goal to potentially accelerate proof-of-concept outcomes ( ). They are collaborating with the FDA, aiming for an outcome by Q1 2026 ( ). Regarding the EMA application, the subcutaneous option may not directly impact the current reexamination process, which focuses on intravenous LEQEMBI ( ). -
Physician Feedback on LEQEMBI
Q: Are physicians showing less favorable views on LEQEMBI?
A: Alisha Alaimo stated that they are not experiencing pushback from physicians regarding LEQEMBI's risk-benefit or cost-benefit ratios ( ). She emphasized that physicians prescribing LEQEMBI understand the data and are actively working to get patients treated, indicating strong conviction in the therapy's importance ( ). CEO Chris Viehbacher added that the increasing number of prescribing physicians and depth of ordering suggest growing confidence and commitment to LEQEMBI ( ). -
Lupus Portfolio Expectations
Q: What are your expectations for upcoming lupus data?
A: Priya Singhal expressed excitement about the upcoming readout for dapirolizumab (DAP) in systemic lupus erythematosus (SLE) ( ). The Phase III trial investigates safety and efficacy over 48 weeks, aiming for meaningful changes on primary endpoints and acceptable safety profiles ( ). If results are positive, they expect to run another Phase III study, with planning already underway ( ). -
SKYCLARYS Patient Persistence
Q: How is patient persistence with SKYCLARYS?
A: Alisha Alaimo reported that discontinuation rates for SKYCLARYS are consistent with clinical trials, and patients tend to stay on therapy ( ). Physicians set appropriate expectations, advising patients to stay on treatment for at least a year ( ). They are past the catch-up population and are now in the patient identification phase, using AI tools to identify additional patients, which is promising for growth ( ). -
Company Challenges Ahead
Q: What challenges remain for Biogen?
A: CEO Chris Viehbacher acknowledged ongoing challenges, including potential biosimilar competition for TYSABRI and important patent litigation for TECFIDERA in Europe ( ). He emphasized the company's strong scientific and medical capabilities, focusing on smart capital deployment, and transforming passive capital into active growth opportunities ( ). Biogen aims to build its R&D portfolio internally and externally to drive future growth ( ). -
Angelman Syndrome Program
Q: Why did you opt out of the Angelman program with Ionis?
A: Priya Singhal explained that Biogen employs disciplined decision-making based on data readouts and predefined go/no-go criteria ( ). After evaluating the BIIB121 data, they decided not to continue investment due to the assessment of the probability of technical and regulatory success ( ). The focus remains on programs with compelling data and established regulatory pathways ( ).
- Given surveys indicating a less favorable view among neurologists and Alzheimer's specialists regarding LEQEMBI's risk-benefit and cost-benefit ratios, and some questioning the amyloid hypothesis, how is Biogen addressing these concerns, and are you experiencing any pushback from healthcare providers who were initially ready to prescribe LEQEMBI?
- With the EMA's negative opinion on LEQEMBI, what specific steps is Biogen taking to reverse this decision, and what is your confidence level that the decision can be overturned through reexamination, considering the issues raised by the EMA?
- For SKYCLARYS, can you provide more details on patient discontinuation rates and how they compare to clinical trial data, and what strategies are you implementing to ensure patient adherence, especially among those who may not see immediate efficacy?
- After opting out of the Angelman syndrome program with Ionis, how has your approach to evaluating partnerships and collaborations evolved, and what specific aspects of potential programs are you now scrutinizing more closely before committing resources?
- Given competitive pressures on your core products and the need for successful new launches, what gives you confidence that 2023 will be the trough year for earnings, and what are the key factors that need to play out for Biogen to achieve sustainable growth through the end of the decade?
Q2 2024 Earnings Call
- Issued Period: Q2 2024
- Guided Period: FY 2024
- Guidance:
- Non-GAAP Diluted EPS: Raised to a range of $15.75 to $16.25, reflecting expected growth of approximately 9% at the midpoint compared to 2023.
- Total Revenue: Expected to decline by a low single-digit percentage compared to 2023, with core pharmaceutical revenue expected to be roughly flat year-over-year.
- Operating Income: Expected to grow at a mid- to high teen percentage.
- Combined Non-GAAP R&D and SG&A Expense: Expected to be approximately $4.3 billion.
- Interest Income: Reduction of approximately $20 million expected for the remainder of 2024 due to lower cash balances and associated lower interest income from the HI-Bio acquisition .
Q1 2024 Earnings Call
- Issued Period: Q1 2024
- Guided Period: FY 2024
- Guidance:
- Non-GAAP Diluted EPS: Expected to be between $15 and $16, reflecting expected growth of approximately 5% at the midpoint compared to 2023.
- Revenue Expectations: Skewed more towards the second half of the year due to timing of shipments for SPINRAZA outside the U.S. and growth profiles for recently launched products.
- SPINRAZA Revenue: Expected to decline by a low single-digit percentage.
- Cost Savings: Fit for Growth program on track to achieve cost savings of $1 billion gross and $800 million net by the end of 2025 .
Q4 2023 Earnings Call
- Issued Period: Q4 2023
- Guided Period: FY 2024
- Guidance:
- Non-GAAP Diluted EPS: Expected to be between $15 and $16, with an expected EPS growth of approximately 5% at the midpoint.
- Total Revenue: Expected to decline by a low mid-single-digit percentage.
- Core Pharmaceutical Revenue: Expected to be relatively flat compared to 2023.
- Contract Manufacturing Revenue: Expected to be significantly lower throughout 2024.
- Cost of Sales as a Percentage of Revenue: Expected to improve.
- Operating Income and Margins: Expected to grow at a low double-digit percentage in operating income and by a mid-single-digit percentage in operating margins.
- Combined R&D and SG&A Spend: Expected to total approximately $4.3 billion.
- Fit-for-Growth Savings: Approximately $400 million of net savings expected by the end of 2024, with the remainder of the $800 million target to be achieved by 2025 .
Q3 2024 Earnings Call
- Issued Period: Q3 2024
- Guided Period: N/A
- Guidance: The documents do not contain information about Biogen's guidance provided in the Q3 2024 earnings call. Therefore, no specific metrics or guidance details are available for this period .
Competitors mentioned in the company's latest 10K filing.
- Sanofi Genzyme: Competitor for AUBAGIO (teriflunomide) in the MS market .
- Banner Life Sciences: Competitor for BAFIERTAM (monomethyl fumarate) in the MS market .
- Bayer Group: Competitor for BETASERON/BETAFERON (interferon-beta-1b) in the MS market .
- TG Therapeutics, Inc.: Competitor for BRIUMVI (ublituximab-xiiy) in the MS market .
- Teva Pharmaceuticals Industries Ltd.: Competitor for COPAXONE (glatiramer acetate) in the MS market .
- Novartis AG: Competitor for EXTAVIA (interferon-beta-1b), GILENYA (fingolimod), KESIMPTA (ofatumumab), and MAYZENT (siponimod) in the MS market .
- Sandoz, a division of Novartis AG: Competitor for GLATOPA (glatiramer acetate) and TYRUKO (natalizumab-sztn) in the MS market .
- Genentech: Competitor for OCREVUS (ocrelizumab) in the MS market .
- Janssen Pharmaceutical Companies of Johnson & Johnson: Competitor for PONVORY (ponesimod) in the MS market .
- EMD Serono: Competitor for REBIF (interferon-beta-1) and MAVENCLAD (cladribine) in the MS market .
- Bristol Myers Squibb Company: Competitor for ZEPOSIA (ozanimod) in the MS market .
- TG Therapeutics, Inc.: Competitor for BRIUMVI (ublituximab-xiiy) in the MS market .
- Samsung Bioepis: Partner for biosimilars BENEPALI, IMRALDI, FLIXABI, and BYOOVIZ, which compete with ENBREL, HUMIRA, REMICADE, and LUCENTIS, respectively .
- Genentech: Competitor for RITUXAN, RITUXAN HYCELA, GAZYVA, and LUNSUMIO in oncology and rheumatoid arthritis markets .
- Teva Pharmaceuticals Industries Ltd.: Competitor for COPAXONE (glatiramer acetate) in the MS market .
- Novartis AG: Competitor for EXTAVIA (interferon-beta-1b), GILENYA (fingolimod), KESIMPTA (ofatumumab), and MAYZENT (siponimod) in the MS market .
- Sandoz, a division of Novartis AG: Competitor for GLATOPA (glatiramer acetate) and TYRUKO (natalizumab-sztn) in the MS market .
- Genentech: Competitor for OCREVUS (ocrelizumab) in the MS market .
- Janssen Pharmaceutical Companies of Johnson & Johnson: Competitor for PONVORY (ponesimod) in the MS market .
- EMD Serono: Competitor for REBIF (interferon-beta-1) and MAVENCLAD (cladribine) in the MS market .
- Bristol Myers Squibb Company: Competitor for ZEPOSIA (ozanimod) in the MS market .
Recent developments and announcements about BIIB.
Corporate Leadership
CFO Change
Michael McDonnell, the current Chief Financial Officer (CFO) of Biogen Inc., will retire on March 1, 2025. Robin Kramer, the current Chief Accounting Officer, has been appointed as the new CFO effective upon his retirement.
Leadership Change
Michael McDonnell is retiring as Chief Financial Officer of Biogen Inc. on March 1, 2025. Robin Kramer will step up as the new Chief Financial Officer. Sean Godbout has been appointed as Vice President, Chief Accounting Officer & Global Corporate Controller, effective March 1, 2025, replacing Robin Kramer in that role.
CFO Change
Michael McDonnell, the Chief Financial Officer of Biogen Inc., has announced his retirement effective February 28, 2025. Robin Kramer, currently the Chief Accounting Officer, will succeed him as CFO .