Otsuka's Voyxact Launch Successful; IgAN Treatment Market Potential Exceeds $40 Billion

Overview

This research report is based on a meeting between Goldman Sachs and the Investor Relations department of Otsuka Holdings (Otsuka HD), analyzing the market performance and industry impact of its newly launched IgA Nephropathy (IgAN) therapy drug, Voyxact (sibeprenlimab). The report indicates that Voyxact has progressed smoothly during its initial US launch, reaching a broad patient base and benefiting from clinical guidelines recommending early intervention. Goldman Sachs believes these drugs could unlock the IgAN treatment market, with an estimated US market size exceeding $40 billion, generating positive spillover effects on similarly mechanismed drugs from VERA and Vertex.

Core views

Strong Performance at Voyxact Launch: Otsuka Holdings stated that since the late last year, Voyxact has been progressing well in the US, accumulating over 1,000 new patient initiation forms by the end of March 2026. The drug is not only suitable for treatment-naive patients but also for those switching from existing medications; it covers both severe and relatively early-stage cases, indicating high market demand for APRIL/APRIL-BAFF inhibitors. Guideline Updates Create Tailwinds: The updated KDIGO guidelines in 2025 emphasized early diagnosis and intervention for IgAN, recommending early biopsy and active treatment for adults with proteinuria of at least 0.5g/d. Otsuka Holdings believes this expands the treatment population and facilitates uptake of new therapies. Positive Impact on Covered Names: Goldman Sachs views Voyxact's successful launch as validation of the commercial potential of this mechanism, sending positive signals for VERA's atacicept and Vertex's povetacicept. Although VERA and Vertex drugs have not yet received full approval or launch, Voyxact's prescription acceptance despite the lack of Phase III eGFR functional data has bolstered market confidence in similar drugs.

Analysis framework

The report utilizes a combination of top-down industry analysis and bottom-up company valuation. First, meeting minutes were used to obtain frontline sales data and physician prescribing behaviors (e.g., patient types, insurance negotiation progress) to validate early-stage product commercialization performance. Second, structural expansion in industry demand was analyzed in conjunction with changes in clinical guidelines (KDIGO). Finally, different valuation models (DCF, M&A analysis) were applied to different companies to determine price targets, with detailed listing of key risk points and subsequent data tracking nodes (e.g., timing of eGFR data reads) for each company.

Methodology notes

• Valuation MethodDCF Cash Flow Discounting

  DCF Valuation Model

  The report utilized the DCF model to value Otsuka HD, VERA, and VRTX, calculating intrinsic value by assuming WACC (Weighted Average Cost of Capital) and terminal growth rates, representing one of the core methods for valuing biopharmaceutical companies.

• Valuation Method

  M&A Valuation Analysis

  VERA's valuation incorporated M&A analysis, assigning it an M&A rating of 1 (high probability of acquisition), and calculated M&A valuation using a sales multiple method. This was weighted against DCF results to derive the final price target, reflecting the industry characteristic that biotech companies are frequently acquired.

• Industry/Industrial Analysis Framework

  Clinical Guideline Impact Analysis

  The report analyzed the impact of updated KDIGO clinical practice guidelines on treatment standards, noting that the emphasis on early intervention will expand the patient pool, which is a critical perspective for assessing policy/guideline-driven demand changes in the pharmaceutical industry.

Asset mapping & comparison

Structured mapping from thesis to named assets (strengths, weaknesses, peers, risks).

• Otsuka HD (4578.T)

  Direct beneficiary; Voyxact is a key growth driver

  Strengths

  First-in-class drug status, smooth launch progress, broad patient coverage

  Weaknesses

  Must await 24-month eGFR data to verify long-term efficacy

  Comparison

  Currently holds a leading launch position among such drugs

  Risks

  Key drug sales below expectations, development delays, health supplement business risks

• Vera Therapeutics Inc. (VERA)

  Indirect beneficiary; similar mechanism drug atacicept expected to follow

  Strengths

  Potential best-in-class data, high M&A attractiveness

  Weaknesses

  Not yet approved, reliant on Phase III ORIGIN 3 trial results

  Comparison

  PDUFA date set for July 7, 2026, slightly later than Voyxact

  Risks

  Poor clinical trial results, competitive assets performing better, launch challenges

• Vertex Pharmaceuticals Inc. (VRTX)

  Indirect beneficiary; positive commercial prospects for povetacicept

  Strengths

  Strong commercialization capabilities, priority review qualification

  Weaknesses

  Similarly lacks Phase III functional data labeling, reliant on proteinuria endpoint for accelerated approval

  Comparison

  Expected approval in December 2026; convenience (monthly injection) may be superior to competitors

  Risks

  Clinical/technical setbacks, reimbursement failure, competition threats, IP protection risks

Key data

• Voyxact 1Q Sales¥4.7 billionFirst quarter of 2026, progressing well towards the H1 guidance of ¥6 billion
• New Patient Initiation Forms>1,000 formsAccumulated data through end of March 2026
• US IgAN Market Forecast> $40 billionPotential market size forecast by Goldman Sachs
• Otsuka HD Target Price12,400 Yen12-month target price, based on DCF model
• VERA Target Price$9512-month target price, weighted average of DCF and M&A valuation
• VRTX Target Price$64112-month target price, based on 100% DCF value

Impact & implications

For Otsuka HD, Voyxact is confirmed as a key growth driver, and the smooth launch validates its first-in-class status. For VERA and Vertex, the commercial dynamics of Voyxact provide a positive benchmark for similar APRIL/BAFF inhibitors, particularly regarding physicians' willingness to prescribe even without Phase III functional data, thereby reducing market education costs for subsequent similar drugs. Overall, the IgAN treatment sector is entering a period of rapid development, and the trend toward early intervention will accelerate market penetration.

Risks

• Key drug sales below expectations or sales suspension
• Drug development pause or delay
• Clinical trial results underperforming expectations (e.g., ORIGIN 3)
• Competitive clinical assets performing better in trials
• Launch challenges and failure to protect first-mover advantage
• Reimbursement and pricing pressure
• IP portfolio protection failure

What to watch

• Voyxact eGFR data: Mid-term analysis at ERA conference on June 5, 24-month data in June-August
• Atacicept eGFR data: Expected by end of 2026
• Povetacicept approval progress: Expected approval in December 2026
• Subsequent revisions to KDIGO guidelines: Expected revision in 2027 based on new data
• Auto-injector (AI) formulation progress: Voyxact expected to file in H2 2026