aeb30edc0ea6c2f150fce056770ef23487cebc8de6f45ffc11e3f38e7ae0021d

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 **[0000875045-24-000009_biib-20231231.htm:244]**. The company offers a range of products, including treatments for multiple sclerosis (MS), rare diseases, and biosimilars **[0000875045-24-000009_biib-20231231.htm:185]**. 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 **[0000875045-24-000009_biib-20231231.htm:29]**.

1. **Multiple Sclerosis (MS) Treatments** - Provides a comprehensive suite of therapies for MS, including TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI, and FAMPYRA.
2. **Rare Disease Treatments** - Offers specialized treatments for rare diseases, featuring products like SPINRAZA, QALSODY, and SKYCLARYS.
3. **Biosimilars** - Develops and markets biosimilar products, including BENEPALI, IMRALDI, FLIXABI, and BYOOVIZ.

da4c696786723956de39f16d151e33896bf8f6717301fe248b7403062a740726

| Metric [Unit: $ Million] | Q4 2022 | Q1 2023 | Q2 2023 | Q3 2023 | Q4 2023 | Q1 2024 | Q2 2024 | Q3 2024 |
|--------------------------|---------|---------|---------|---------|---------|---------|---------|---------|
| **Multiple Sclerosis (MS)** | **1,268.8**  **[BIIB_3228168_1]** **[0000875045-23-000005_exhibit991-q42022pressrele.htm:1]** **[0000875045-23-000005_exhibit991-q42022pressrele.htm:9]**  | **1,125.2**  **[0000875045-23-000016_biib-20230331.htm:14]**  | **1,209.3**  **[0000875045-23-000027_exhibit991-q22023pressrele.htm:0]** **[0000875045-23-000030_biib-20230630.htm:54]**  | **1,159**  **[0000875045-23-000035_exhibit991-q32023pressrele.htm:1]** **[0000875045-23-000038_biib-20230930.htm:62]**  | **1,168**  **[0000875045-24-000004_exhibit991-q42023pressrele.htm:1]**  | **1,075.9**  **[0000875045-24-000016_biib-20240331.htm:17]** **[0000875045-24-000012_exhibit991-q12024pressrele.htm:7]** **[0000875045-24-000016_biib-20240331.htm:46]**  | **1,149.8**  **[0000875045-24-000022_exhibit991-q22024pressrele.htm:1]** **[0000875045-24-000022_exhibit991-q22024pressrele.htm:8]**  | **1,053.9**  **[0000875045-24-000032_biib-20240930.htm:23]** **[0000875045-24-000032_biib-20240930.htm:61]**  |
| **Rare Disease/SMA** | **458.8**  **[BIIB_3228168_1]** **[0000875045-23-000005_exhibit991-q42022pressrele.htm:1]** **[0000875045-23-000005_exhibit991-q42022pressrele.htm:9]**  | **443.3**  **[0000875045-23-000016_biib-20230331.htm:14]**  | **437.1**  **[0000875045-23-000027_exhibit991-q22023pressrele.htm:0]** **[0000875045-23-000030_biib-20230630.htm:54]**  | **448**  **[0000875045-23-000035_exhibit991-q32023pressrele.htm:1]** **[0000875045-23-000038_biib-20230930.htm:62]**  | **472**  **[0000875045-24-000004_exhibit991-q42023pressrele.htm:1]**  | **423.9**  **[0000875045-24-000016_biib-20240331.htm:17]** **[0000875045-24-000012_exhibit991-q12024pressrele.htm:7]** **[0000875045-24-000016_biib-20240331.htm:46]**  | **534.1**  **[0000875045-24-000022_exhibit991-q22024pressrele.htm:1]** **[0000875045-24-000022_exhibit991-q22024pressrele.htm:8]**  | **494.8**  **[0000875045-24-000032_biib-20240930.htm:23]** **[0000875045-24-000032_biib-20240930.htm:61]**  |
| **Biosimilars** | **174.8**  **[BIIB_3228168_1]** **[0000875045-23-000005_exhibit991-q42022pressrele.htm:1]** **[0000875045-23-000005_exhibit991-q42022pressrele.htm:9]**  | **192.4**  **[0000875045-23-000016_biib-20230331.htm:14]**  | **195.1**  **[0000875045-23-000027_exhibit991-q22023pressrele.htm:0]** **[0000875045-23-000030_biib-20230630.htm:54]**  | **194**  **[0000875045-23-000035_exhibit991-q32023pressrele.htm:1]** **[0000875045-23-000038_biib-20230930.htm:62]**  | **188**  **[0000875045-24-000004_exhibit991-q42023pressrele.htm:1]**  | **196.9**  **[0000875045-24-000016_biib-20240331.htm:17]** **[0000875045-24-000012_exhibit991-q12024pressrele.htm:7]** **[0000875045-24-000016_biib-20240331.htm:46]**  | **198.1**  **[0000875045-24-000022_exhibit991-q22024pressrele.htm:1]** **[0000875045-24-000022_exhibit991-q22024pressrele.htm:8]**  | **196.6**  **[0000875045-24-000032_biib-20240930.htm:23]** **[0000875045-24-000032_biib-20240930.htm:61]**  |
| **Other Products** | **0.3**  **[BIIB_3228168_1]** **[0000875045-23-000005_exhibit991-q42022pressrele.htm:1]** **[0000875045-23-000005_exhibit991-q42022pressrele.htm:9]**  | **2.4**  **[0000875045-23-000016_biib-20230331.htm:14]**  | **4.3**  **[0000875045-23-000027_exhibit991-q22023pressrele.htm:0]** **[0000875045-23-000030_biib-20230630.htm:54]**  | **4**  **[0000875045-23-000035_exhibit991-q32023pressrele.htm:1]** **[0000875045-23-000038_biib-20230930.htm:62]**  | **4**  **[0000875045-24-000004_exhibit991-q42023pressrele.htm:1]**  | **15.2**  **[0000875045-24-000016_biib-20240331.htm:17]** **[0000875045-24-000012_exhibit991-q12024pressrele.htm:7]** **[0000875045-24-000016_biib-20240331.htm:46]**  | **17.6**  **[0000875045-24-000022_exhibit991-q22024pressrele.htm:1]** **[0000875045-24-000022_exhibit991-q22024pressrele.htm:8]**  | **24.1**  **[0000875045-24-000032_biib-20240930.htm:23]** **[0000875045-24-000032_biib-20240930.htm:61]**  |
| **Anti-CD20 Therapeutic Programs** | **448**  **[BIIB_3228168_1]** **[0000875045-23-000005_exhibit991-q42022pressrele.htm:1]**  | **399.5**  **[0000875045-23-000016_biib-20230331.htm:15]**  | **433.4**  **[0000875045-23-000030_biib-20230630.htm:53]**  | **421**  **[0000875045-23-000038_biib-20230930.htm:21]**  | **436**  **[0000875045-24-000004_exhibit991-q42023pressrele.htm:1]**  | **394**  **[0000875045-24-000016_biib-20240331.htm:18]** **[0000875045-24-000016_biib-20240331.htm:47]**  | **445**  **[0000875045-24-000022_exhibit991-q22024pressrele.htm:1]**  | N/A |
| **Contract Manufacturing, Royalty, and Other Revenue** | **192**  **[BIIB_3228168_1]** **[0000875045-23-000005_exhibit991-q42022pressrele.htm:1]**  | **319.1**  **[0000875045-23-000016_biib-20230331.htm:15]**  | **197.5**  **[0000875045-23-000030_biib-20230630.htm:53]**  | **304**  **[0000875045-23-000035_exhibit991-q32023pressrele.htm:1]** **[0000875045-23-000038_biib-20230930.htm:21]**  | **118**  **[0000875045-24-000004_exhibit991-q42023pressrele.htm:1]**  | **184.6**  **[0000875045-24-000016_biib-20240331.htm:18]**  | **121**  **[0000875045-24-000022_exhibit991-q22024pressrele.htm:1]**  | N/A |
| **Total Revenue** | **2,544**  **[BIIB_3228168_1]** **[0000875045-23-000005_exhibit991-q42022pressrele.htm:1]**  | **2,463**  **[0000875045-23-000012_exhibit991-q12023pressrele.htm:7]**  | **2,456**  **[0000875045-23-000027_exhibit991-q22023pressrele.htm:0]**  | **2,530**  **[0000875045-23-000035_exhibit991-q32023pressrele.htm:1]** **[0000875045-23-000035_exhibit991-q32023pressrele.htm:0]**  | **2,386**  **[0000875045-24-000004_exhibit991-q42023pressrele.htm:1]**  | **2,290.5**  **[0000875045-24-000016_biib-20240331.htm:46]**  | **2,465**  **[0000875045-24-000022_exhibit991-q22024pressrele.htm:1]**  | **1,769.4**  **[0000875045-24-000032_biib-20240930.htm:23]** **[0000875045-24-000032_biib-20240930.htm:61]**  |

e181ac025e035ab4ec4f1a096ef4fdc3346e83138aeb1d5275b3684ba72c159a

1761e49f08d221839c7374b128d14cae37249e810bf817a5d49e43d8def26fdb

| Metric [USD Million] | Q4 2022 | Q1 2023 | Q2 2023 | Q3 2023 | Q4 2023 | Q1 2024 | Q2 2024 | Q3 2024 |
|----------------------|---------|---------|---------|---------|---------|---------|---------|---------|
| United States        | N/A     | **701.4**  **[0000875045-23-000016_biib-20230331.htm:14]**  | **801.0**  **[0000875045-23-000027_exhibit991-q22023pressrele.htm:6]**  | **790.9**  **[0000875045-23-000035_exhibit991-q32023pressrele.htm:8]**  | **848.1**  **[0000875045-24-000004_exhibit991-q42023pressrele.htm:9]**  | **746.1**  **[0000875045-24-000016_biib-20240331.htm:46]**  | **846.7**  **[0000875045-24-000022_exhibit991-q22024pressrele.htm:8]**  | **813.0**  **[0000875045-24-000032_biib-20240930.htm:23]**  |
| Rest of World        | N/A     | **1,061.9**  **[0000875045-23-000016_biib-20230331.htm:14]**  | **1,044.8**  **[0000875045-23-000027_exhibit991-q22023pressrele.htm:6]**  | **1,014.3**  **[0000875045-23-000035_exhibit991-q32023pressrele.htm:8]**  | **984.3**  **[0000875045-24-000004_exhibit991-q42023pressrele.htm:9]**  | **965.8**  **[0000875045-24-000016_biib-20240331.htm:46]**  | **1,052.9**  **[0000875045-24-000022_exhibit991-q22024pressrele.htm:8]**  | **956.4**  **[0000875045-24-000032_biib-20240930.htm:23]**  |
| Total Product Revenue| N/A     | **1,763.3**  **[0000875045-23-000016_biib-20230331.htm:14]**  | **1,845.8**  **[0000875045-23-000027_exhibit991-q22023pressrele.htm:6]**  | **1,805.2**  **[0000875045-23-000035_exhibit991-q32023pressrele.htm:8]**  | **1,832.4**  **[0000875045-24-000004_exhibit991-q42023pressrele.htm:9]**  | **1,711.9**  **[0000875045-24-000016_biib-20240331.htm:46]**  | **1,899.6**  **[0000875045-24-000022_exhibit991-q22024pressrele.htm:8]**  | **1,769.4**  **[0000875045-24-000032_biib-20240930.htm:23]**  |

07cc16375700a4c3592483db9fce657b5a1bd529e64e56bb55e4dbc4d874c2c5

1. 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?
2. 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?
3. 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?
4. 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?
5. 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?

ef92fda07464455fca3076148fb4e68b38a299733721a93323b85dedaa6925bc

cd3856ebd29fc5b335b9ded19c60bfa0efb6459695cc60fc3823cb5cf8e95e9e

### 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  **[BIIB_3395657_2]** .

### 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  **[BIIB_3380437_7]** **[BIIB_3380437_8]** **[BIIB_3380437_1]** .

### 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  **[BIIB_3373052_10]** **[BIIB_3373052_9]** .

### 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  **[BIIB_3395657_2]** .

cd254be028a10cb637ea485b3a7f94829c2ffdec2c5ecaf2c152f9260914f2d2

26c914859a143519f6cb7fce29299fe972626c97a1d853b527e8c5a451354479

| Program Details          | Program 1       |
|--------------------------|-----------------|
| Approval Date            | October 2020  **[0000875045-24-000032_biib-20240930.htm:117]** |
| End Date/Duration        | No expiration  **[0000875045-24-000032_biib-20240930.htm:117]** |
| Total additional amount  | **$5.0 billion**  **[0000875045-24-000032_biib-20240930.htm:117]** |
| Remaining authorization amount | **$2.1 billion**  **[0000875045-24-000032_biib-20240930.htm:117]** |
| Details                  | All shares repurchased will be retired  **[0000875045-24-000032_biib-20240930.htm:117]** |

a0ee7e2bf66fd67aa2d95b3d604b5f15cd56e1d4a14e99952254263fe094163a

- **Sanofi Genzyme**: Competitor for AUBAGIO (teriflunomide) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **Banner Life Sciences**: Competitor for BAFIERTAM (monomethyl fumarate) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **Bayer Group**: Competitor for BETASERON/BETAFERON (interferon-beta-1b) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **TG Therapeutics, Inc.**: Competitor for BRIUMVI (ublituximab-xiiy) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **Teva Pharmaceuticals Industries Ltd.**: Competitor for COPAXONE (glatiramer acetate) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **Novartis AG**: Competitor for EXTAVIA (interferon-beta-1b), GILENYA (fingolimod), KESIMPTA (ofatumumab), and MAYZENT (siponimod) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **Sandoz, a division of Novartis AG**: Competitor for GLATOPA (glatiramer acetate) and TYRUKO (natalizumab-sztn) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **Genentech**: Competitor for OCREVUS (ocrelizumab) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **Janssen Pharmaceutical Companies of Johnson & Johnson**: Competitor for PONVORY (ponesimod) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **EMD Serono**: Competitor for REBIF (interferon-beta-1) and MAVENCLAD (cladribine) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **Bristol Myers Squibb Company**: Competitor for ZEPOSIA (ozanimod) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **TG Therapeutics, Inc.**: Competitor for BRIUMVI (ublituximab-xiiy) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **Samsung Bioepis**: Partner for biosimilars BENEPALI, IMRALDI, FLIXABI, and BYOOVIZ, which compete with ENBREL, HUMIRA, REMICADE, and LUCENTIS, respectively  **[0000875045-24-000009_biib-20231231.htm:26]** .
- **Genentech**: Competitor for RITUXAN, RITUXAN HYCELA, GAZYVA, and LUNSUMIO in oncology and rheumatoid arthritis markets  **[0000875045-24-000009_biib-20231231.htm:26]** .
- **Teva Pharmaceuticals Industries Ltd.**: Competitor for COPAXONE (glatiramer acetate) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **Novartis AG**: Competitor for EXTAVIA (interferon-beta-1b), GILENYA (fingolimod), KESIMPTA (ofatumumab), and MAYZENT (siponimod) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **Sandoz, a division of Novartis AG**: Competitor for GLATOPA (glatiramer acetate) and TYRUKO (natalizumab-sztn) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **Genentech**: Competitor for OCREVUS (ocrelizumab) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **Janssen Pharmaceutical Companies of Johnson & Johnson**: Competitor for PONVORY (ponesimod) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **EMD Serono**: Competitor for REBIF (interferon-beta-1) and MAVENCLAD (cladribine) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .
- **Bristol Myers Squibb Company**: Competitor for ZEPOSIA (ozanimod) in the MS market  **[0000875045-24-000009_biib-20231231.htm:24]** .

f0e05545d80cfaf8383b9280c701488dd0abd35d0fc8dec7ec34138f42b45100

Biologics Facility Value (USD)

Office & Lab Space Plano, TX (sq ft)

Lease Liability Plano, TX (USD)

Right-of-Use Asset Plano, TX (USD)

SKYCLARYS Amortization Costs (USD)

Fair Value Step-Up Adjustment SKYCLARYS (USD)

dd727e7860020e41e419277842b3eb8845acdb8844b963cc8a2ef99aab862025

b29097f56f5d4a09e2883429f670704b1918d085ba5c789ec5b39a95cb202f86

**Annual guidance for FY 2024:**
- **Non-GAAP Diluted EPS**: $16.10 to $16.60  **[BIIB_3404622_8]**  (raised from $15.75 to $16.25  **[BIIB_3395657_2]** )  
- **Total Revenue**: Decline by a low single-digit percentage  **[BIIB_3404622_8]**  (no change from prior guidance  **[BIIB_3395657_2]** )  
- **SG&A Expenses**: Seasonally higher in Q4  **[BIIB_3404622_8]**  (no prior guidance)  
- **Fit for Growth Initiative Savings**: $1 billion of gross savings and $800 million of net savings by end of 2025  **[BIIB_3404622_8]**  (no prior guidance)  

4f263650ec8f79f9dd1bed91acbe6d7413144fc31f0c8b8929c4d61386c5988d

| Name                     | Position                                                        | Start Date          | Short Bio                                                                                                                                                                                                 |
|--------------------------|-----------------------------------------------------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Christopher A. Viehbacher | President and Chief Executive Officer                          | November 2022       | Christopher A. Viehbacher has served as the President and CEO of Biogen since November 2022. He was previously the Managing Partner at Gurnet Point Capital and Global CEO of Sanofi S.A.  **[0000875045-24-000009_biib-20231231.htm:52]** **[0001193125-24-118313_d547371ddef14a.htm:17]** **[0000875045-23-000009_biib-20221231.htm:49]** .       |
| Susan H. Alexander       | Executive Vice President, Chief Legal Officer                   | April 2018          | Susan H. Alexander has been serving as the EVP, Chief Legal Officer at Biogen since April 2018. She joined Biogen in 2006 and has held various legal executive roles  **[0000875045-24-000009_biib-20231231.htm:52]** **[0000875045-23-000009_biib-20221231.htm:49]** .                               |
| Michael R. McDonnell     | Executive Vice President and Chief Financial Officer            | August 2020         | Michael R. McDonnell has served as the EVP and CFO of Biogen since August 2020. He plans to retire on February 28, 2025  **[0000875045-24-000009_biib-20231231.htm:53]** **[0000875045-23-000009_biib-20221231.htm:50]** **[0001193125-24-247628_d890797dex991.htm:0]** .                                                                       |
| Nicole Murphy            | Executive Vice President, Pharmaceutical Operations and Technology | February 2022       | Nicole Murphy has served as the EVP, Pharmaceutical Operations and Technology at Biogen since February 2022. She joined Biogen in 2015 and has held various senior executive positions  **[0000875045-24-000009_biib-20231231.htm:52]** **[0000875045-23-000009_biib-20221231.htm:50]** .            |
| Ginger Gregory, Ph.D.    | Executive Vice President and Chief Human Resources Officer      | July 2017           | Ginger Gregory, Ph.D., has served as the EVP and Chief Human Resources Officer at Biogen since July 2017. She previously held HR executive roles at Shire PLC and other companies  **[0000875045-24-000009_biib-20231231.htm:53]** **[0000875045-23-000009_biib-20221231.htm:50]** .                 |
| Rachid Izzar             | Executive Vice President, Global Product Strategy and Commercialization | July 2021          | Rachid Izzar has served as the EVP, Head of Global Product Strategy and Commercialization at Biogen since July 2021. He previously held leadership roles at AstraZeneca  **[0000875045-24-000009_biib-20231231.htm:54]** **[0000875045-23-000009_biib-20221231.htm:52]** .                           |
| Priya Singhal, M.D., M.P.H. | Executive Vice President, Head of Development                  | January 2023        | Priya Singhal, M.D., M.P.H., has served as the EVP and Head of Development at Biogen since January 2023. She rejoined Biogen in 2020 and has held various senior positions  **[0000875045-24-000009_biib-20231231.htm:54]** **[0000875045-23-000009_biib-20221231.htm:52]** .                        |
| Jane Grogan, Ph.D.      | Executive Vice President, Head of Research                       | September 2023      | Jane Grogan, Ph.D., has served as the EVP, Head of Research at Biogen since September 2023. She was previously the Chief Scientific Officer at Graphite Bio and ArsenalBio  **[0000875045-24-000009_biib-20231231.htm:10]** **[0000875045-24-000009_biib-20231231.htm:54]** .                        |
| Adam Keeney, Ph.D.       | Executive Vice President, Head of Corporate Development         | April 2023          | Adam Keeney, Ph.D., has served as the EVP and Head of Corporate Development at Biogen since April 2023. He was previously the CEO of NodThera and held roles at Sanofi  **[0000875045-24-000009_biib-20231231.htm:55]** .                               |
| Robin C. Kramer          | Senior Vice President, Chief Accounting Officer                 | December 2020       | Robin C. Kramer has served as the SVP, Chief Accounting Officer at Biogen since December 2020. She will become CFO effective February 28, 2025  **[0000875045-24-000009_biib-20231231.htm:55]** **[0001193125-24-247628_d890797d8k.htm:1]** **[0001193125-24-247628_d890797dex991.htm:0]** .                                                |

9e79969f6a8ca30bf91346e55731f6933781fa238f841d875291e54fea416bcc

United States

Europe

- Germany

Asia

Other

Rest of World

Total Revenue

506e18fa012beeed17452db31f9f945beac8caf04832ce482aff70fc6bc63827

| Name                          | Start Date | End Date | Reason for Change |
|-------------------------------|------------|----------|-------------------|
| PricewaterhouseCoopers LLP   | 2003  **[0000875045-24-000009_biib-20231231.htm:251]**    | Present  | Current auditor   |

a30a6504a2ef51f252a857cfbe962459dc740435d433fe20a689e61ee502b379

b624503e59d11a422c8af81068028a5fd906d2cfc830ae34aaa74d127fe180c9

23794d91c53ae875c8e247d72561e35d9d06ee07c70c9e0dbcc977a6d161504a

ebdd6f88c7cabc9f2e1e551df74875b3c2a73dac2e6e99b3b92de5dd70475bbf

- Total Revenue: $2,465.8 million (-3% YoY)  **[0000875045-24-000032_biib-20240930.htm:60]** **[0000875045-24-000032_biib-20240930.htm:6]** **[0000875045-24-000032_biib-20240930.htm:23]** **[0000875045-23-000038_biib-20230930.htm:61]** **[0000875045-23-000038_biib-20230930.htm:6]**   
- Operating Income (EBIT): $451 million (improved from -$141.2 million YoY)  **[0000875045-24-000032_biib-20240930.htm:6]** **[0000875045-23-000038_biib-20230930.htm:6]**   
- Net Income: **$388.5 million** (improved from -$68.1 million YoY)  **[0000875045-24-000032_biib-20240930.htm:6]** **[0000875045-23-000038_biib-20230930.htm:6]**   
- Multiple Sclerosis: $1,053.9 million (-9% YoY)  **[0000875045-24-000032_biib-20240930.htm:60]** **[0000875045-24-000032_biib-20240930.htm:6]** **[0000875045-24-000032_biib-20240930.htm:23]** **[0000875045-23-000038_biib-20230930.htm:62]** **[0000875045-23-000038_biib-20230930.htm:19]**   
- Rare Disease: $494.8 million (**+10%** YoY)  **[0000875045-24-000032_biib-20240930.htm:60]** **[0000875045-24-000032_biib-20240930.htm:6]** **[0000875045-24-000032_biib-20240930.htm:23]** **[0000875045-23-000038_biib-20230930.htm:62]** **[0000875045-23-000038_biib-20230930.htm:19]**   
- Anti-CD20 Therapeutic Programs: $446.2 million (**+6%** YoY)  **[0000875045-24-000032_biib-20240930.htm:60]** **[0000875045-24-000032_biib-20240930.htm:6]** **[0000875045-24-000032_biib-20240930.htm:23]** **[0000875045-23-000038_biib-20230930.htm:61]** **[0000875045-23-000038_biib-20230930.htm:6]**   
- Contract Manufacturing, Royalty, and Other: $250.2 million (**-18%** YoY)  **[0000875045-24-000032_biib-20240930.htm:60]** **[0000875045-24-000032_biib-20240930.htm:6]** **[0000875045-24-000032_biib-20240930.htm:23]** **[0000875045-23-000038_biib-20230930.htm:61]** **[0000875045-23-000038_biib-20230930.htm:6]**   
- Other Segment: $24.1 million (**+551%** YoY)  **[0000875045-24-000032_biib-20240930.htm:60]** **[0000875045-24-000032_biib-20240930.htm:6]** **[0000875045-24-000032_biib-20240930.htm:23]** **[0000875045-23-000038_biib-20230930.htm:62]** **[0000875045-23-000038_biib-20230930.htm:19]**   
- Rest of World: $956.4 million (**-6%** YoY)  **[0000875045-24-000032_biib-20240930.htm:60]** **[0000875045-23-000038_biib-20230930.htm:62]** **[0000875045-23-000038_biib-20230930.htm:61]**   

647e8adaa7575a743b75f8fb64f8753e2f8fce0317a3e62879ba0fa59de9346e

6b8ef2e09efe0b6cab132899555267f1dabcba9b4bd41dca8d4b8596866dd5b7

- **Strong Early Uptake of LEQEMBI:** Biogen's recent product launches, especially **LEQEMBI for Alzheimer's disease**, are demonstrating robust early uptake, with **patient volume accelerating**, expanding access, and plans to **expand the field force by 30%**, suggesting a **significant commercial opportunity over the mid to long term**.  **[BIIB_3380437_4]**
- **Strategic Diversification into Rare Diseases and Immunology:** Biogen is **diversifying its R&D pipeline** into adjacent areas like **rare diseases and immunology** to achieve more **predictable R&D outcomes**, while maintaining its commitment to neurology. This **strategic shift** may expand their growth opportunities.  **[BIIB_3380437_11]** **[BIIB_3380437_19]** **[BIIB_3380437_18]**
- **Strong Financial Position for Growth Initiatives:** Biogen has a **strong balance sheet** with **net debt of approximately $5 billion**, generating about **$3 billion of EBITDA** and **$2 billion of free cash flow per year**, providing capacity for **business development and potential acquisitions**, which could enhance growth prospects.  **[BIIB_3380437_11]** **[BIIB_3380437_19]**

34d1ea777304fea8afa019dcb064c6935ff89fb67fe3c5ef429befa4a9f09027

- Biogen expects **significant value from SKYCLARYS** following the acquisition of Reata Pharmaceuticals, with plans for expansion into the EU and Latin America, and is accelerating efforts to file for approval in these regions. Additionally, they are in discussions with regulators for a **pediatric study**, which is important to broaden the patient base.  **[BIIB_3365146_13]**
- Biogen and Eisai are preparing to file data for **LEQEMBI maintenance dosing** with intravenous infusion every four weeks by **Q1 2024**, potentially enhancing treatment options for Alzheimer's disease patients.  **[BIIB_3365146_14]**
- Biogen remains confident in securing a **positive CHMP opinion for SKYCLARYS** from the EMA in early 2024, with regulatory interactions ongoing and expectations remaining on track for approval.  **[BIIB_3365146_21]**

2a72fe27f4e8a4cbe3913abcef2b7651f27a5ddb7ba32857c11523c86d2f9ee8

- *1. Regulatory hurdles for LEQEMBI subcutaneous formulation:** The FDA is requiring additional immunogenicity data for the subcutaneous version of LEQEMBI, which could delay its approval and **limit market potential**.  **[BIIB_3380437_17]**
- *2. Challenges in LEQEMBI's commercial launch:** Biogen is facing significant obstacles in launching LEQEMBI due to **complex market dynamics and infrastructure hurdles**, including difficulties for physicians in prescribing the treatment and setting up necessary pathways. This could impact **sales growth**.  **[BIIB_3380437_2]**
- *3. Shifting focus due to high risks in neuroscience and narrowing opportunities in MS:** The company acknowledges that neuroscience is a **high-risk area** and not diversified enough for a company of their size. Additionally, the unmet need in multiple sclerosis (MS) has **narrowed**, leading them to seek growth opportunities in other areas. This shift may indicate **challenges in their core business areas**.  **[BIIB_3380437_11]** **[BIIB_3380437_18]**

92a4bbad84931ac4df5e531ec9a8c469de0ffbb419557a8005eaabe391316d28

| Year | Amount Due (in millions) | Debt Type | Interest Rate (%) | % of Total Debt |
|------|--------------------------|-----------|-------------------|-----------------|
| 2025 | $1,748.1 **[0000875045-24-000032_biib-20240930.htm:31]**         | 4.050% Senior Notes **[0000875045-24-000032_biib-20240930.htm:31]** | 4.050 **[0000875045-24-000032_biib-20240930.htm:31]** | 27.8% = (1,748.1 / 6,293.9) * 100 **[0000875045-24-000032_biib-20240930.htm:31]** **[0000875045-24-000032_biib-20240930.htm:7]** |
| 2030 | $1,494.5 **[0000875045-24-000032_biib-20240930.htm:31]**         | 2.250% Senior Notes **[0000875045-24-000032_biib-20240930.htm:31]** | 2.250 **[0000875045-24-000032_biib-20240930.htm:31]** | 23.7% = (1,494.5 / 6,293.9) * 100 **[0000875045-24-000032_biib-20240930.htm:31]** **[0000875045-24-000032_biib-20240930.htm:7]** |
| 2045 | $1,101.0 **[0000875045-24-000032_biib-20240930.htm:31]**         | 5.200% Senior Notes **[0000875045-24-000032_biib-20240930.htm:31]** | 5.200 **[0000875045-24-000032_biib-20240930.htm:31]** | 17.5% = (1,101.0 / 6,293.9) * 100 **[0000875045-24-000032_biib-20240930.htm:31]** **[0000875045-24-000032_biib-20240930.htm:7]** |
| 2050 | $1,474.8 **[0000875045-24-000032_biib-20240930.htm:31]**         | 3.150% Senior Notes **[0000875045-24-000032_biib-20240930.htm:31]** | 3.150 **[0000875045-24-000032_biib-20240930.htm:31]** | 23.4% = (1,474.8 / 6,293.9) * 100 **[0000875045-24-000032_biib-20240930.htm:31]** **[0000875045-24-000032_biib-20240930.htm:7]** |
| 2051 | $475.5 **[0000875045-24-000032_biib-20240930.htm:31]**           | 3.250% Senior Notes **[0000875045-24-000032_biib-20240930.htm:31]** | 3.250 **[0000875045-24-000032_biib-20240930.htm:31]** | 7.6% = (475.5 / 6,293.9) * 100 **[0000875045-24-000032_biib-20240930.htm:31]** **[0000875045-24-000032_biib-20240930.htm:7]** |

40a0964256e463944f10a11c2813fba079ea04e0e085402e07ef8c027539d43f

- **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.  **[BIIB_3395657_12]** ,  **[BIIB_3395657_1]**
- **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.  **[BIIB_3395657_1]** ,  **[BIIB_3395657_7]**
- **Cost reduction initiatives are exceeding goals**, leading to **improved margins and significant EPS growth**, positioning the company for sustainable growth from **2025 to 2030**.  **[BIIB_3395657_12]** ,  **[BIIB_3395657_1]**

7881d6f2c4f0fba716433da97dd1b541114f0f7f55e1526a3a01bbc050aac358

1. **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 ( **[BIIB_3395657_1]** ). He highlighted the stabilizing top line and the focus on cost savings programs that improve operating performance and free up capital for growth initiatives ( **[BIIB_3395657_1]** ). 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 ( **[BIIB_3395657_1]** ).

2. **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 ( **[BIIB_3395657_1]** ). 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** ( **[BIIB_3395657_1]** ). 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 ( **[BIIB_3395657_1]** ).

3. **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 ( **[BIIB_3395657_1]** ). The focus is on areas where Biogen has strong capabilities, such as immunology and rare diseases, avoiding competitive auctions to prevent overpaying ( **[BIIB_3395657_1]** ). 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 ( **[BIIB_3395657_1]** ).

4. **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 ( **[BIIB_3395657_1]** ). They are collaborating with the FDA, aiming for an outcome by **Q1 2026** ( **[BIIB_3395657_1]** ). Regarding the EMA application, the subcutaneous option may not directly impact the current reexamination process, which focuses on intravenous LEQEMBI ( **[BIIB_3395657_1]** ).

5. **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 ( **[BIIB_3395657_1]** ). 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 ( **[BIIB_3395657_1]** ). CEO Chris Viehbacher added that the increasing number of prescribing physicians and depth of ordering suggest growing confidence and commitment to LEQEMBI ( **[BIIB_3395657_1]** ).

6. **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) ( **[BIIB_3395657_1]** ). The Phase III trial investigates safety and efficacy over **48 weeks**, aiming for meaningful changes on primary endpoints and acceptable safety profiles ( **[BIIB_3395657_1]** ). If results are positive, they expect to run another Phase III study, with planning already underway ( **[BIIB_3395657_1]** ).

7. **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 ( **[BIIB_3395657_1]** ). Physicians set appropriate expectations, advising patients to stay on treatment for at least a year ( **[BIIB_3395657_1]** ). 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 ( **[BIIB_3395657_1]** ).

8. **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 ( **[BIIB_3395657_1]** ). He emphasized the company's strong scientific and medical capabilities, focusing on smart capital deployment, and transforming passive capital into active growth opportunities ( **[BIIB_3395657_1]** ). Biogen aims to build its R&D portfolio internally and externally to drive future growth ( **[BIIB_3395657_1]** ).

9. **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 ( **[BIIB_3395657_1]** ). After evaluating the BIIB121 data, they decided not to continue investment due to the assessment of the probability of technical and regulatory success ( **[BIIB_3395657_1]** ). The focus remains on programs with compelling data and established regulatory pathways ( **[BIIB_3395657_1]** ).

5f356c154ffbd21ef194c7e61d87a2473ced98084338759f33216ef526854e81

- **SPINRAZA shows signs of returning to growth**: Despite competition from oral therapies and gene therapies, SPINRAZA is stabilizing and moving back toward a modest growth trajectory. Biogen is targeting adult SMA patients, where only about **30% of patients with SMA are actually treated**, and is developing a **high-dose SPINRAZA program** that could improve patient convenience and competitiveness.  **[BIIB_3373052_21]**
- **SKYCLARYS has significant growth potential**: SKYCLARYS has over **20% of the potential patient population on therapy within about 6 months of launch** in the U.S. Biogen is working with the **Friedreich’s Ataxia Research Alliance** to identify patients and making genetic tests more available. European approval has been granted, and global expansion is underway.  **[BIIB_3373052_18]**
- **Promising pipeline in Angelman Syndrome and Lupus**: Biogen's **BIIB121 program for Angelman Syndrome** may have competitive advantages due to its unique ASO backbone and dosing schedule, with dosing potentially needed at a **quarterly level**. The company expects midyear data that could lead to a pivotal study. Additionally, the **Phase III lupus program** (dapirolizumab pegol) is appropriately powered and positioned to provide a clear readout on therapeutic potential, with results expected **mid-2024**.  **[BIIB_3373052_14]** **[BIIB_3373052_20]**

8c4233a3ccc94face349ad8334d22fd2c6d4e96a85dd5ca8f296337aeb3d6877

- **Uncertainty surrounding EMA approval of SKYCLARYS in the EU market**, which represents about **one-third** of the value of the Reata acquisition, could impact Biogen's expected revenue growth. The company expects an outcome in early 2024 but could not comment on whether there will be an oral explanation, indicating potential regulatory hurdles.  **[BIIB_3365146_21]**
- **Lack of clarity on the regulatory path and potential approval for LEQEMBI maintenance dosing**, which could affect the drug's long-term market potential. Biogen is preparing data for a potential filing by Q1 2024 but cannot comment on the indication or regulatory outcome, creating uncertainty about future approvals.  **[BIIB_3365146_14]**
- **Delays in converting patient interest into actual prescriptions for SKYCLARYS** suggest challenges in reimbursement and access, potentially limiting revenue growth. Of **1,180** start forms submitted, only **860** patients are actually on the drug, indicating bottlenecks that the company needs to address.  **[BIIB_3365146_13]**

edc201a91cc805e5fe10258ccc8508bae4ac06294a62f07486d445be37547522

- **SPINRAZA** is facing increasing competition from **oral therapies and gene therapies**, which may affect its ability to return to growth.  **[BIIB_3373052_21]**
- **SKYCLARYS**'s growth is expected to **moderate in 2024** due to complexities in patient identification, diagnosis, and reimbursement processes, potentially impacting its contribution to revenue growth.  **[BIIB_3373052_18]**
- Challenges in Biogen's **lupus programs**, including **reduced trial size** and potential misalignment with regulatory expectations on **study endpoints**, may impact approval prospects.  **[BIIB_3373052_14]**

4013bc85e5dc21506cad42f1714103cfe7bb12e70210b1cfd240311f377968fc

- **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.  **[BIIB_3395657_12]**
- **LEQEMBI received a negative opinion from the EMA**, casting doubt on its approval in the EU and potentially **limiting its global market potential**.  **[BIIB_3395657_4]**
- **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.  **[BIIB_3395657_7]**

e6eec39b89457d5e10ce7a8ede9d16c1831f43468365b2b91c77e9024eeb1877

1. **LEQEMBI Commercialization Progress**  
   **Q:** When will LEQEMBI see more pull-through from expanded efforts?  
   **A:** Management expects steady progress with LEQEMBI, adding prescribers and seeing more sales every week.  **[BIIB_3404622_9]**  The expanded field force is driving growth, with new writers increasing by **40%** in Q3 versus Q2.  **[BIIB_3404622_9]**  They believe that upcoming innovations, like the subcutaneous formulation expected next year, could be a game changer.  **[BIIB_3404622_9]** 

2. **LEQEMBI Subcutaneous Filing Timeline**  
   **Q:** Update on subcutaneous LEQEMBI filings for maintenance and induction?  
   **A:** The subcutaneous maintenance filing is expected to be imminent.  **[BIIB_3404622_10]**  Data generation and analysis for initiation therapy are ongoing, with a regulatory outcome anticipated by Q1 of **2026**.  **[BIIB_3404622_10]** 

3. **Pipeline Peak Revenue Potential**  
   **Q:** Discuss the $14B peak revenue potential from key programs.  
   **A:** Management is excited about four key pipeline programs with a potential peak revenue of $9 to **$14 billion**.  **[BIIB_3404622_15]**  They highlighted BIIB080 in Alzheimer's and several programs in lupus as significant opportunities.  **[BIIB_3404622_15]** 

4. **Business Development Strategy**  
   **Q:** Any updates on business development strategy moving forward?  
   **A:** Biogen is actively looking for assets that could enhance near-term revenue growth while creating shareholder value.  **[BIIB_3404622_12]**  They have **$8 to $10 billion** of capacity over the next year or two for potential acquisitions or collaborations.  **[BIIB_3404622_12]** 

5. **SPINRAZA Growth Potential**  
   **Q:** How can SPINRAZA return to growth after softer numbers?  
   **A:** Despite competition, SPINRAZA is seeing growth, driven by switchbacks from competitors and finding new patients.  **[BIIB_3404622_16]**  Management believes that the upcoming high-dose formulation will support continued growth.  **[BIIB_3404622_16]** 

6. **Margins Outlook for 2025**  
   **Q:** Directional thoughts on margins for 2025?  
   **A:** Management expects continued improvement in operating income margin, aided by achieving **$800 million** in net savings by the end of next year.  **[BIIB_3404622_17]** 

7. **Pipeline Focus Strategy**  
   **Q:** Is Biogen shifting focus away from neurology?  
   **A:** Biogen remains committed to neuroscience but sees opportunities in immunology, particularly in areas where they have capabilities.  **[BIIB_3404622_15]**  They plan to expand into immunology and rare diseases while maintaining their neuroscience investments.  **[BIIB_3404622_15]** 

8. **SKYCLARYS Pricing Challenges**  
   **Q:** Comment on SKYCLARYS pricing and reimbursement challenges.  
   **A:** Revenue generation for SKYCLARYS varies by country due to reimbursement timelines.  **[BIIB_3404622_11]**  Patient demand is ahead of revenue, leading to some lumpiness in quarterly numbers.  **[BIIB_3404622_11]** 

9. **Lupus R&D Investment**  
   **Q:** How does lupus R&D investment compete with emerging therapies?  
   **A:** Management believes multiple options will be required for lupus treatment.  **[BIIB_3404622_14]**  They are confident in their programs addressing different pathways and remain optimistic about their potential.  **[BIIB_3404622_14]** 

10. **AHEAD 3-45 Study Timeline**  
    **Q:** Update on AHEAD 3-45 study timeline and potential?  
    **A:** Enrollment is completed, and the trials have a **216-week** time point.  **[BIIB_3404622_13]**  Management is engaging with regulators and exploring all options for when results might be ready.  **[BIIB_3404622_13]** 

3a4b7f4c6fe7577a6dfc06f9d13566ee9b20db874fd5aee7bb4c9e0f1464109d

1. **LEQEMBI Subcutaneous Formulation**  
   **Q:** What's the status of LEQEMBI's subcutaneous filing?  
   **A:** Biogen is collaborating with Eisai to provide a subcutaneous formulation of LEQEMBI. The FDA requires additional immunogenicity data before submission. They aim to submit a rolling application for subcutaneous maintenance as soon as possible, potentially this year, pending fast-track designation. They are optimizing the dose due to higher exposure with subcutaneous administration and expect to file for subcutaneous induction therapy by the first quarter of **2026**, as communicated by Eisai.  **[BIIB_3380437_10]** **[BIIB_3380437_16]** 

2. **Business Development Strategy**  
   **Q:** How does LEQEMBI influence your business development plans?  
   **A:** This year, Biogen is focusing on bringing in new assets in early-stage research and development. While committed to neuroscience, they believe it's not diversified enough and plan to expand into adjacent areas like rare diseases and immunology, leveraging their strong commercial capabilities. Their balance sheet is robust, with net debt around **$5 billion** and generating about **$3 billion** of EBITDA. They have **$4 to $5 billion** of capacity for potential deals in **2024**, with larger acquisitions potentially in **2025** or beyond.  **[BIIB_3380437_11]** 

3. **SKYCLARYS Market Penetration**  
   **Q:** What's the outlook for SKYCLARYS market penetration?  
   **A:** In the U.S., Biogen has achieved **24%** market penetration with SKYCLARYS and plans to continue adding patients every month. Having completed the "catch-up" population, they're now targeting less-engaged patients by expanding the field force. In Europe, they've launched in Germany, Austria, and the Czech Republic, with full EU revenue expected in **2025**. They also plan to launch in Brazil in early **2025**.  **[BIIB_3380437_12]** **[BIIB_3380437_14]** 

4. **LEQEMBI Commercialization and Salesforce**  
   **Q:** Is your LEQEMBI salesforce adequate?  
   **A:** Biogen's approach is stepwise. They started with a focused salesforce targeting top accounts, aligning with site readiness post-approval. As the market matures, they're expanding the U.S. footprint by **30%**, focusing on large integrated delivery networks now opening up. This expansion was always planned and informed by analytics and third-party input.  **[BIIB_3380437_15]** **[BIIB_3380437_19]** 

5. **Shift in R&D Focus**  
   **Q:** Are you shifting focus away from R&D?  
   **A:** Biogen has four data readouts coming midyear and continues to be disciplined in R&D prioritization. They've optimized their R&D portfolio with projects of conviction or those awaiting data. They plan to build out the pipeline to diversify their business, focusing on areas like rare diseases and immunology, but remain committed to neuroscience.  **[BIIB_3380437_17]** **[BIIB_3380437_18]** 

6. **Dapirolizumab in Lupus**  
   **Q:** Can you update on dapirolizumab in lupus?  
   **A:** Biogen has refined the Phase III trial for dapirolizumab in systemic lupus erythematosus (SLE), focusing on a **48-week** endpoint using BICLA, a sensitive measure of SLE disease activity. They've modified the trial design and population, aiming for meaningful change on primary and key secondary endpoints to bring dapirolizumab to patients quickly.  **[BIIB_3380437_13]** 

1fcaad801c85f608d3c837d949dcbb4596d317f770a73bc316c49ce6991060c9

1. **LEQEMBI Subcutaneous Filing**  
   **Q:** Will LEQEMBI's subcutaneous form be filed in Q1 2024?  
   **A:** Yes, Biogen and Eisai plan to file the subcutaneous formulation of **LEQEMBI by the end of March 2024**, following positive bioequivalence data and ongoing discussions with regulators.  **[BIIB_3373052_12]** **[BIIB_3373052_19]** 

2. **LEQEMBI Launch Bottlenecks**  
   **Q:** What bottlenecks are affecting LEQEMBI's launch?  
   **A:** The main bottlenecks are coordinating patient scheduling for initial **MRI scans** and **access to neurologists**. Aligning infusion initiation with MRI appointments is causing delays, despite no MRI capacity constraints.  **[BIIB_3373052_13]** 

3. **Expanding LEQEMBI Resources**  
   **Q:** Why is Biogen adding more LEQEMBI resources?  
   **A:** Biogen is increasing field resources alongside Eisai to expand LEQEMBI's reach. Initially, one company led the field effort for efficiency. With better insights and more activated sites, both companies are now scaling up to reach more patients.  **[BIIB_3373052_15]** 

4. **Competition with Donanemab**  
   **Q:** How will LEQEMBI compete with donanemab?  
   **A:** Biogen believes LEQEMBI has a significantly better safety profile regarding **ARIA** and, with its upcoming subcutaneous form, will offer greater convenience. The company will adjust its commercial strategy based on final labels and continues to focus on these competitive advantages.  **[BIIB_3373052_12]** 

5. **LEQEMBI Subcutaneous in Naïve Patients**  
   **Q:** Is there enough data for subcutaneous LEQEMBI in new patients?  
   **A:** Biogen and Eisai believe they have sufficient data, including from **72 treatment-naïve patients**, to support regulatory submission. A larger cohort provides additional safety data, and discussions with regulators are ongoing.  **[BIIB_3373052_16]** 

6. **AHEAD 3-45 Study Timing**  
   **Q:** When is the AHEAD 3-45 interim analysis?  
   **A:** The AHEAD 3-45 trial is enrolling well, targeting preclinical Alzheimer's disease at different amyloid levels. An interim analysis opportunity exists, but **no specific timelines have been communicated** yet.  **[BIIB_3373052_19]** 

7. **SKYCLARYS European Launch**  
   **Q:** What is SKYCLARYS's launch plan in Europe?  
   **A:** SKYCLARYS has been approved in the EU and will launch first in **Germany**. Early access programs are active in **France** and being negotiated elsewhere. Uptake may be slower than in the U.S. due to reimbursement processes, but Europe has a **higher incidence of Friedreich's ataxia per capita**.  **[BIIB_3373052_17]** **[BIIB_3373052_18]** 

8. **SKYCLARYS Growth Trajectory**  
   **Q:** How will SKYCLARYS growth progress in 2024?  
   **A:** After an initial surge due to pent-up demand, growth will moderate as Biogen shifts to identifying new patients. The company doesn't expect another **20%** growth this year but anticipates steady monthly increases contributing to overall growth in 2024.  **[BIIB_3373052_18]** 

9. **CD40 Phase III in Lupus**  
   **Q:** Has the CD40 lupus trial reduced in size?  
   **A:** Yes, the trial size decreased from **450 to 320 patients** to balance study design with the desire to expedite potential treatment delivery. Biogen believes the study remains appropriately powered and expects results in **mid-2024**.  **[BIIB_3373052_14]** 

10. **Angelman Syndrome Program**  
    **Q:** Will Biogen continue the Angelman program?  
    **A:** Biogen will decide midyear whether to opt into a pivotal program based on data from the ongoing Phase Ib trial. The program may offer competitive advantages due to its unique ASO backbone and quarterly dosing schedule.  **[BIIB_3373052_20]** 

11. **SPINRAZA Return to Growth**  
    **Q:** How will Biogen grow SPINRAZA sales?  
    **A:** Biogen plans to target **adult SMA patients**, who are often underdiagnosed, as only about **30%** of SMA patients are currently treated. Demonstrating SPINRAZA's efficacy after gene therapy and developing a high-dose formulation may also support growth.  **[BIIB_3373052_21]** 

12. **ZURZUVAE Launch Metrics**  
    **Q:** What are early signs from the ZURZUVAE launch?  
    **A:** Early metrics are encouraging, with both high-prescribing psychiatrists and **OB-GYNs** prescribing ZURZUVAE. Payers are moving quickly to ensure patient access, and prescriptions are coming faster than anticipated, bolstering confidence in the launch.  **[BIIB_3373052_22]** 

8837fc9de1724330310a5022e4b91ab4f96eb38ccd9fd65f39cd81306522b3c3

Biogen Inc (BIIB)

Financials