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Research from Water Tower Research

Water Tower Research is a leading equity research firm that provides research on micro, small and mid cap companies.

Water Tower Research was founded by Wall Street veterans after witnessing a fundamental shift in the investment research industry with the result being a declining knowledge base among investors, a lack of awareness and a shrinking pool of fundamental research being conducted on companies across the small-cap and micro-cap spectrum. The same issues are now increasingly occurring in the mid-cap space. This sea change within the investment community is impacting not only the companies themselves but also current shareholders and potential investors. With significantly less active sell-side sponsorship by Wall Street, a substantial information gap has developed between companies and various constituents in the financial community. The net result is fewer channels for insight and information to flow between companies and investors.

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<ul><li>Last week, IONS matched Ultragenyx’s Angelman benefit, with maybe better safety.</li><li>PFE and SGMO had approvable gene therapy results in hemophilia A, but durability remains a question.</li><li>BIIB had a bad week, as SAGE-partnered essential tumor trial failed and ESAIY-partnered lecanemab in Alzheimer’s hit an EU regulatory wall. </li></ul>

Last week, IONS matched Ultragenyx’s Angelman benefit, with maybe better safety.PFE and SGMO had approvable gene therapy results in hemophilia A, but durability remains a question.BIIB had a bad week, as SAGE-partnered essential tumor trial failed and ESAIY-partnered lecanemab in Alzheimer’s hit an EU regulatory wall. 

<ul><li>We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.</li><li>Eli Lilly and Company (LLY) received FDA approval for donanemab (Kisunla) in early Alzheimer’s, which was largely expected following unanimous support from the June AdComm and multiple delays.</li><li>The cost of Kisunla is $32K/year, which is at a premium to Leqembi (Biogen, Inc. [BIIB]/Eisai Co., Ltd. [ESAIY]) at $26.5K/year, but total cost per patient should be lower for Kisunla, as treatment can be stopped with amyloid clearance.</li></ul>

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.Eli Lilly and Company (LLY) received FDA approval for donanemab (Kisunla) in early Alzheimer’s, which was largely expected following unanimous support from the June AdComm and multiple delays.The cost of Kisunla is $32K/year, which is at a premium to Leqembi (Biogen, Inc. [BIIB]/Eisai Co., Ltd. [ESAIY]) at $26.5K/year, but total cost per patient should be lower for Kisunla, as treatment can be stopped with amyloid clearance.

Equity Bottom-Up

<ul><li>First blood-based IVD test for Alzheimer’s approved.</li><li>On May 16, 2025, the FDA announced that it had approved for marketing an in-vitro diagnostic (IVD) device that tests blood to aid in diagnosing Alzheimer’s, granting it a 501 (k) clearance.</li><li>This is the first diagnostic blood test for Alzheimer’s to be approved by the FDA.</li></ul>

First blood-based IVD test for Alzheimer’s approved.On May 16, 2025, the FDA announced that it had approved for marketing an in-vitro diagnostic (IVD) device that tests blood to aid in diagnosing Alzheimer’s, granting it a 501 (k) clearance.This is the first diagnostic blood test for Alzheimer’s to be approved by the FDA.

Biogen, Inc: Catalysts for Accelerating Leqembi Demand Growth

<ul><li>2025 guidance reaffirmed despite better-than- expected 1Q25 revenues.</li><li>Despite beating expectations with a 6% Y/Y growth in reported revenues to $2.4B (8% Y/Y growth on a constant currency basis) for 1Q25, Biogen nevertheless maintained its full year revenue guidance for a mid-single digit drop in constant currency (CC) revenues, which will make it the sixth consecutive year of revenue decline for the company.</li><li>Although Biogen lowered its 2025 non-GAAP EPS guidance range to $14.50-$15.50 from the previous range of $15.25- $16.25, this negative revision is not a sign of unanticipated business deterioration. </li></ul>

2025 guidance reaffirmed despite better-than- expected 1Q25 revenues.Despite beating expectations with a 6% Y/Y growth in reported revenues to $2.4B (8% Y/Y growth on a constant currency basis) for 1Q25, Biogen nevertheless maintained its full year revenue guidance for a mid-single digit drop in constant currency (CC) revenues, which will make it the sixth consecutive year of revenue decline for the company.Although Biogen lowered its 2025 non-GAAP EPS guidance range to $14.50-$15.50 from the previous range of $15.25- $16.25, this negative revision is not a sign of unanticipated business deterioration. 

Biogen, Inc. - Steady as She Goes as the Ship Continues to Turn Slowly

<ul><li>Biogen built its reputation on a differentiated modality-agnostic approach to drug development, deploying innovative technologies to address complex and intractable diseases.</li><li>This innovative approach yielded the company’s golden era, which lasted ~20 years from the mid- 1990s to 2017. During this period, Biogen enjoyed near unrivaled leadership in the disease-modifying treatment of multiple sclerosis (MS).</li><li>But the adage of ‘all good things must come to an end’ could not be more of a truism for the company, as genericization and the entry of more efficacious next-generation treatments began to erode revenue from its MS franchise. </li></ul>

Biogen built its reputation on a differentiated modality-agnostic approach to drug development, deploying innovative technologies to address complex and intractable diseases.This innovative approach yielded the company’s golden era, which lasted ~20 years from the mid- 1990s to 2017. During this period, Biogen enjoyed near unrivaled leadership in the disease-modifying treatment of multiple sclerosis (MS).But the adage of ‘all good things must come to an end’ could not be more of a truism for the company, as genericization and the entry of more efficacious next-generation treatments began to erode revenue from its MS franchise. 

Biogen, Inc: Breakthrough Drug Developer in Reset Mode; Initiating Coverage

United States

Biogen Inc. develops, manufactures, and commercializes therapies, focusing on neurology, oncology, and immunology. The Company's products address diseases such as multiple sclerosis, non-Hodgkin's lymphoma, rheumatoid arthritis, Crohn's disease, and psoriasis.

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Biogen Inc (BIIB US)

Biopharma Week in Review - Jul 29, 2024

Last week, IONS matched Ultragenyx’s Angelman benefit, with maybe better safety. PFE and SGMO had approvable gene therapy results in hemophilia A,...

Water Tower Research

Biopharma Week in Review - Jul 8, 2024

The cost of Kisunla is $32K/year, which is at a premium to Leqembi (Biogen, Inc. [BIIB]/Eisai Co., Ltd. [ESAIY]) at $26.5K/year, but total cost per...

Water Tower Research

Biogen, Inc: Catalysts for Accelerating Leqembi Demand Growth

On May 16, 2025, the FDA announced that it had approved for marketing an in-vitro diagnostic (IVD) device that tests blood to aid in diagnosing...

Water Tower Research

Biogen, Inc. - Steady as She Goes as the Ship Continues to Turn Slowly

Despite beating expectations with a 6% Y/Y growth in reported revenues to $2.4B (8% Y/Y growth on a constant currency basis) for 1Q25

Water Tower Research

Biogen, Inc: Breakthrough Drug Developer in Reset Mode; Initiating Coverage

Biogen built its reputation on a differentiated modality-agnostic approach to drug development, deploying innovative technologies to address...

Water Tower Research

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