Biogen Inc. (NASDAQ:BIIB) Morgan Stanley’s 22nd Annual Global Healthcare Conference September 4, 2022 10:00 AM ET Company Participants Mike McDonnell – Chief Financial Officer Priya Singhal – Executive Vice President and Head-Development Conference Call Participants Terence Flynn – Morgan Stanley Terence Flynn Okay, great. I think we're going to get started, but thanks for joining us, everyone. I'm Terence Flynn, the U.S. biopharma analyst at Morgan Stanley. We're very pleased to be hosting Biogen today. Fr ...

Positive study demonstrates the potential for investigational higher dose nusinersen regimen to advance the treatment of SMA; Biogen plans to submit for regulatory approval of this investigational dose regimenHigher dose nusinersen regimen showed statistically significant improvement compared to a prespecified matched sham control groupAmong key measures of clinical efficacy, higher dose regimen showed positive trends compared to the approved dosing regimen CAMBRIDGE, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) ...

Biogen (BIIB) stock has declined 20.9% so far this year against an increase of 28.6% for the industry. The stock has also underperformed the sector and the S&P 500 index, as seen in the chart below.BIIB Stock Underperforms Industry, Sector & S&P 500Image Source: Zacks Investment ResearchThe company’s stock performance has been below most large drugmakers’ performance. Biogen's revenues declined 3.3% in the first six months of 2024. Sales of Biogen’s key multiple sclerosis (“MS”) drugs like Tecfidera and Tys ...

vuk8691/iStock via Getty Images Investment Overview I last covered Biogen (NASDAQ:BIIB), the Cambridge, Massachusetts based pharmaceutical company, focused primarily on central nervous system diseases, for Seeking Alpha in April this year, shortly after the company announced its Q1 2024 earnings - revenues of $1.71bn, down 3% year-on-year, and non-GAAP earnings per share ("EPS") of $3.7, up 8% year-on-year - giving the stock a "Buy" Recommendation. Nearly four months on, and with Q2 earnings having been ...

Investing based on the segment's long-term prospects is likely to be very lucrative.I predict that a gold rush in longevity medicines is going to start in the next half-decade or so. That's right: Biotech and pharma companies are going to try developing drugs that can extend human lifespan. And eventually, they're going to succeed, at least somewhat.The early competitors are already getting down to work. Soon enough, there will surely be great opportunities for investment -- as well as a sea of opportunitie ...

These companies have approved Alzheimer's treatments that could generate billions in revenue for their respective businesses.One thing that can help with the treatment of any disease is early detection, and Alzheimer's is no exception to that. And the good news is that in the near future, detecting cases of Alzheimer's disease could simply involve a blood test.A new wave of blood tests involves checking for p-tau217, which is an abnormal protein that can help accurately detect 90% of Alzheimer's cases. The ...

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PART I — FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=8&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the company's unaudited condensed consolidated financial statements for the periods ended June 30, 2024, and 2023 Condensed Consolidated Statements of Income Highlights (in millions, except per share data) | Metric | Q2 2024 | Q2 2023 | YTD 2024 | YTD 2023 | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | $2,464.9 | $2,456.0 | $4,755.4 | $4,919.0 | | **Net Income** | $583.6 | $593.3 | $977.0 | $980.9 | | **Diluted EPS** | $4.00 | $4.07 | $6.70 | $6.74 | Condensed Consolidated Balance Sheets Highlights (in millions) | Metric | June 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Total Current Assets** | $7,108.5 | $6,859.3 | | **Total Assets** | $26,804.1 | $26,844.8 | | **Total Current Liabilities** | $3,108.2 | $3,434.3 | | **Total Liabilities** | $10,915.0 | $12,045.4 | | **Total Equity** | $15,889.1 | $14,799.4 | Condensed Consolidated Statements of Cash Flow Highlights (in millions) | Metric | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | **Net cash flow from operating activities** | $1,179.0 | $942.3 | | **Net cash flow from investing activities** | $400.5 | $(1,706.5) | | **Net cash flow from financing activities** | $(684.8) | $(53.2) | [Notes to Condensed Consolidated Financial Statements](index=14&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - Biogen completed the acquisition of Reata Pharmaceuticals on September 26, 2023, for approximately **$7.2 billion**, acquiring SKYCLARYS, the first approved treatment for Friedreich's Ataxia[48](index=48&type=chunk)[50](index=50&type=chunk) - On July 2, 2024, Biogen completed the acquisition of HI-Bio for an upfront payment of **$1.15 billion**, plus potential milestones, to augment its immunology pipeline with the lead asset felzartamab[62](index=62&type=chunk) - In April 2024, the company sold a rare pediatric disease Priority Review Voucher (PRV) for **$103.0 million**, recognizing a net gain of **$88.6 million**[64](index=64&type=chunk) - The "Fit for Growth" restructuring program, initiated in July 2023, is expected to generate approximately **$1.0 billion in gross operating expense savings** by the end of 2025[67](index=67&type=chunk) - The **$1.0 billion term loan** drawn for the Reata acquisition was **fully repaid** as of June 30, 2024[134](index=134&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=48&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management analyzes financial performance for Q2 and H1 2024, covering revenue trends, cost initiatives, and strategic acquisitions [Results of Operations](index=54&type=section&id=Results%20of%20Operations) Revenue by Segment - Q2 2024 vs Q2 2023 (in millions) | Segment | Q2 2024 | Q2 2023 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Multiple Sclerosis** | $1,149.8 | $1,209.3 | $(59.5) | (4.9)% | | **Rare Disease** | $534.1 | $438.0 | $96.1 | 21.9% | | **Biosimilars** | $198.1 | $195.1 | $3.0 | 1.5% | | **Anti-CD20 Programs** | $444.5 | $433.4 | $11.1 | 2.6% | | **Contract Mfg, Royalty & Other** | $120.8 | $176.8 | $(56.0) | (31.7)% | | **Total Revenue** | **$2,464.9** | **$2,456.0** | **$8.9** | **0.4%** | - The **4.9% decrease in Multiple Sclerosis revenue** in Q2 2024 was primarily driven by competition impacting TYSABRI and declining demand for Interferons as patients switch to higher-efficacy therapies[250](index=250&type=chunk) - **Rare Disease revenue grew 21.9%** in Q2 2024, largely due to **$100.0 million in global revenue from SKYCLARYS**, which was acquired in the Reata transaction[253](index=253&type=chunk) Cost and Expense Highlights - Q2 2024 vs Q2 2023 (in millions) | Expense Line | Q2 2024 | Q2 2023 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Cost of Sales** | $546.0 | $592.7 | $(46.7) | (7.9)% | | **Research & Development** | $513.9 | $584.2 | $(70.3) | (12.0)% | | **Selling, General & Administrative** | $553.8 | $548.0 | $5.8 | 1.1% | | **Total Cost and Expense** | **$1,766.2** | **$1,747.9** | **$18.3** | **1.0%** | - **Research and Development expense decreased by 12.0%** in Q2 2024, primarily due to cost-reduction measures from portfolio prioritization and the 'Fit for Growth' program[284](index=284&type=chunk) - **Selling, General and Administrative expense increased by 1.1%** in Q2 2024, driven by higher spending to support the launches of LEQEMBI and SKYCLARYS[288](index=288&type=chunk) [Financial Condition, Liquidity and Capital Resources](index=70&type=section&id=Financial%20Condition,%20Liquidity%20and%20Capital%20Resources) - **Cash and cash equivalents increased to $1.91 billion** as of June 30, 2024, from $1.05 billion at December 31, 2023[304](index=304&type=chunk)[311](index=311&type=chunk) - The company generated **$1.18 billion in net cash flow from operations** during the first six months of 2024, an **increase of 25.1%** from the prior year period[313](index=313&type=chunk)[316](index=316&type=chunk) - Key cash inflows in H1 2024 included the final **$437.5 million payment from Samsung BioLogics** for the Bioepis sale and **$103.0 million from a PRV sale**, while key outflows included **$650.0 million for debt repayment**[311](index=311&type=chunk)[317](index=317&type=chunk)[318](index=318&type=chunk) - In July 2024, the company used available cash on hand to fund the **$1.15 billion acquisition of HI-Bio**[305](index=305&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=74&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks from foreign currency, credit, and equity prices, using hedging to mitigate foreign exchange impacts - The company's primary market risks are **foreign currency exchange, credit risk, and equity price risk**[333](index=333&type=chunk) - A hypothetical 10% adverse movement in foreign currency exchange rates would result in a decrease of approximately **$256.2 million** in the fair value of outstanding forward contracts as of June 30, 2024[337](index=337&type=chunk) - A hypothetical 10% adverse movement in equity prices would decrease the fair value of the company's strategic investment portfolio by approximately **$30.3 million** as of June 30, 2024[339](index=339&type=chunk) [Item 4. Controls and Procedures](index=75&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded its disclosure controls and procedures were effective as of June 30, 2024, with no material changes to internal controls - Management concluded that **disclosure controls and procedures were effective** as of the end of the period covered by the report (June 30, 2024)[341](index=341&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter ended June 30, 2024, that have materially affected, or are reasonably likely to materially affect, internal controls[344](index=344&type=chunk) PART II — OTHER INFORMATION [Item 1. Legal Proceedings](index=77&type=section&id=Item%201.%20Legal%20Proceedings) This section references Note 21 for details on ongoing legal matters, including litigation, patent disputes, and government investigations - Details on legal proceedings are provided in **Note 21** of the condensed consolidated financial statements[346](index=346&type=chunk) [Item 1A. Risk Factors](index=77&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from product concentration, competition, pricing pressures, and the execution of strategic initiatives - The company is **substantially dependent on revenue from its products**, which face increasing competition from generics, biosimilars, and new originator therapies[347](index=347&type=chunk) - **Long-term success depends on the successful development of new products** and additional indications, a process that is expensive and highly uncertain[347](index=347&type=chunk) - Risks exist in executing strategic initiatives, including realizing anticipated benefits from the **Reata and HI-Bio acquisitions** and achieving savings from the **'Fit for Growth' program**[351](index=351&type=chunk) - Sales are subject to intense pressure on **pricing and reimbursement** from third-party payors and government bodies, including potential impacts from the Inflation Reduction Act (IRA)[351](index=351&type=chunk)[353](index=353&type=chunk) - Manufacturing is complex and subject to risks, including **reliance on third-party and single-source suppliers**, which could lead to supply disruptions[367](index=367&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=92&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No common stock was repurchased in Q2 2024, with approximately $2.1 billion remaining available under the current repurchase program - There were **no share repurchases** of common stock during the three and six months ended June 30, 2024[391](index=391&type=chunk) - Approximately **$2.1 billion remained available** under the 2020 Share Repurchase Program as of June 30, 2024[391](index=391&type=chunk) [Item 5. Other Information](index=92&type=section&id=Item%205.%20Other%20Information) No directors or officers entered into or terminated any Rule 10b5-1 trading arrangements during the second quarter of 2024 - **No trading arrangements** for the purchase or sale of Biogen securities were entered into or terminated by Directors or Officers during Q2 2024[392](index=392&type=chunk) [Item 6. Exhibits](index=93&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the report, including corporate governance documents and required Sarbanes-Oxley certifications - The report includes various exhibits, such as the **Biogen Inc. 2024 Omnibus Equity Plan** and certifications from the CEO and CFO[395](index=395&type=chunk)

Biogen (BIIB) reported second-quarter 2024 adjusted earnings per share (EPS) of $5.28, beating the Zacks Consensus Estimate of $4.00. Earnings rose 31% year over year. Earnings benefited from the sale of one of Biogen's two priority review vouchers (PRV). Excluding PRV sales, adjusted earnings rose 18% in the quarter.Total revenues came in at $2.47 billion, flat on a reported basis and up 1% on a constant-currency basis from the year-ago quarter as lower sales of key multiple sclerosis (MS) drugs like Tecfi ...

Biogen Inc. (NASDAQ:BIIB) Q2 2024 Earnings Call Transcript August 1, 2024 8:30 AM ET Company Participants Chuck Triano - Head of IR Chris Viehbacher - President and CEO Alisha Alaimo - Head and President of North America Priya Singhal - Head of Development Travis Murdoch - Head of HI-Bio Mike McDonnell - CFO Conference Call Participants Salveen Richter - Goldman Sachs Evan Seigerman - BMO Capital Markets Michael DiFiore - Evercore ISI Nicole Gabreski - Piper Sandler Paul Matteis - Stifel Michael Yee - Jeffe ...