WOLFE RESEARCH HEALTHCARE CONFERENCE 2026 - MORPHOSYS AG

Explicit Guidance:

• Core business (X-JACIFY) revenue trajectory: On track to reach at least $3–4 billion by 2030.
• Company post-2029 growth potential: Projected to grow at a top-quartile rate of 10–15% (CAGR).
• Pipeline value (unadjusted basis): Estimated at $8–10 billion.
• Monjuvi (Tibsovo) revenue outlook: Potential to double current size if FDA approval is obtained for frontline DLBCL (expected early 2027).
• Opsalora (HS) revenue potential: Sizable product path approaching $0.5 billion in sales if launched successfully.
• Povacitinib revenue potential: Estimated to approach or exceed $1 billion annually post-launch across three indications (HS, PN, Vitiligo).
• Formulary coverage for X-JACIFY: Target of 80–90% coverage to be achieved by the end of the current year (2026).
• Cash Flow/Balance Sheet: Balance sheet expected to grow to $6 billion by 2030 if not utilized for business development.

Business-Segment Outlook:

• X-JACIFY (Core):
  • XR (X-JAKIFY): Current conversion rate ~3%; projected to land between 10–30% (midpoint 15%) over the next two years (2026–2027).
  • Povacitinib: Anticipated FDA approval in early 2027. Expected to secure a label covering both pre-biologic and post-biologic settings for Psoriasis (PN) and Atopic Dermatitis (HS).
  • Opsalora: Data for mild-to-moderate HS expected end of year. Commercial launch anticipated 2027.
• Pipeline (MPNs):
  • 989 (Colt-AR): Pivotal trials in 2nd-line ET/MF ongoing. Frontline MF study design to be finalized early 2027, with trial launch in first half of 2027. Data on JAK-Fi eligible patients to be presented ASH (end of year).
  • 798 (Next-gen Colt-AR): Preclinical data to be disclosed via poster. Pivotal trials expected to start in 2028. Expected to be first-in-class antibody approved and eventual successor to 989.
• Pipeline (Oncology):
  • G12D: Lead indication in frontline pancreatic cancer (PDAC) in combination with chemotherapy; partnerships established with BMS (PRMT5), Innovation (PARP), and GenMab (EGFR).
  • Colorectal Cancer (CRC): Pivotal trial in 2nd/3rd line (predominantly 3rd line) launching immediately; Frontline data (with Cetuximab or Repotrectinib) expected next year.
  • TGF-beta bispecific: Phase 3 study enrolling for online MSS colorectal cancer (ahead of schedule); PFS data expected next year.
• Non-JACIFY Hematology: Timvo, Monjuvi, and Zio expected to show growth moderation in 2026/2027 (entering 3rd year of launch) but remain key growth drivers.

Market and Competitive Outlook:

• Psoriasis (PN) & HS:
  • Povacitinib positioned as the first oral multi-cytokine inhibitor; expected to create a mini-oligopoly in vitiligo.
  • Pricing Strategy: Positioned in the middle of the $17s and Renvoke price corridors.
  • Formulary Dynamics: Anticipated to encounter three access scenarios: open access, P-to-label (step therapy), and step-through biosimilar.
• MPNs:
  • 798 expected to become "best-in-class" with superior potency against non-Type 1 mutations and a predicted human half-life of ~50 days (enabling monthly or less frequent dosing).
  • 798 will render 989 obsolete upon its approval, assuming successful development.
• Pancreatic/Colorectal Cancer:
  • Strategy focused on combination therapies to cover broad market share across molecular subtypes (KRAS, EGFR, etc.).
  • G12D in PDAC aims to provide multiple options for physicians/patients based on molecular profiling.
  • TGF-beta program shows 15% response rate as a single agent in MSS colorectal (0% for PD-1 in liver mets), creating high unmet need; 83% response rate observed in PD-L1 positive liver mets subset.

Macro / Industry Outlook:

• Regulatory: Expect FDA action on Monjuvi frontline DLBCL early 2027; pivotal trial designs for 989 frontline MF to be finalized with FDA early 2027.
• Competitive Landscape: Acknowledges BMS, Innovature, and GenMab collaborations as standard competitive responses; views competition as part of a "large lucrative, attractive market" rather than a zero-sum share battle.
• Industry Trend: Shift toward biomarker-driven selection (molecular profiling) for pancreatic cancer treatment decisions.

Strategic Initiatives:

• Formulary Expansion: Achieve 80–90% formulary coverage for X-JACIFY by year-end 2026.
• Sales Force: Leverage existing 300+ sales representatives to launch HS and PN indications (Povacitinib/Opsalora); targeting 10,000 physicians.
• Product Launches:
  • Povacitinib: Launch early 2027 (PN, Vitiligo, HS).
  • 989 Frontline Study: Launch first half of 2027.
  • 798 Pivotal Trials: Start 2028.
  • Vitiligo Approval: Expected early 2028.
• Business Development (M&A/Partnerships):
  • Focus on assets approvable in 2029–2032 window.
  • Active in Hematology, Oncology, Immunology.
  • Agnostic to therapeutic area; flexible on deal stage (early stage/low upfront vs. later stage/high upfront).
  • Ongoing discussions regarding pan-RAS/pan-KRAS inhibitors and TGF-beta collaborations.
• Development: Advancing 798 to subcutaneous pre-filled syringe and exploring auto-injector/pen development.

Risks and Headwinds to Outlook:

• Biology Risk: Remains non-zero; specifically for TGF-beta, requires PFS/survival data to be fully de-risked (expected H1 2027).
• Regulatory Uncertainty: Final study design for 989 frontline MF (Type 1 vs. all-comers, 2-arm vs. 3-arm) pending FDA conversation and data confirmation.
• Competition: Renvoke and 17s competitors in HS/PN; Epkinley/Polivi in DLBCL.
• Execution Risk: Commercial success depends on conversion rates (XR from 3% to 10–30%) and formulary access (step therapy hurdles).
• Pricing Pressure: Pricing corridor for HS market is narrow; reliance on PBM negotiations.
• Data Readiness: PFS separation for TGF-beta not yet mature; data "event-driven" rather than fixed timeline.

Management Tone on the Future:

• Confidence Level: High confidence in post-2029 growth trajectory (top-quartile 10–15%).
• Sentiment: Describes framework as "intact" and "progressed significantly." Calls 989, G12D, and Latar Support "high PTs projects" (likely "high probability of success/value").
• Caution: Cautiously optimistic on TGF-beta; emphasizes waiting for PFS data before de-risking.
• Self-Perception: Views company as transitioning from "Jackify" (JAK inhibitor) focus to a broader pipeline-driven recovery.
• Strategic View: Believes they have "all the ingredients" to become a top quartile growth company; focuses on execution over "heroic assumptions."

Miscellaneous:

• Timeline Summary:
  • 2026: Formulary coverage for XR; Opsalora HS data; 989 study design finalization.
  • 2027: Povacitinib approval (PN/HS/Vitiligo); 989 frontline study launch; Monjuvi frontline action; 798 clinical data.
  • 2028: 798 pivotal trials; Vitiligo approval.
  • 2029+: Core business $3–4B; Top-quartile growth regime.
• Asset Specifics:
  • Opsalora: Phase 2 HS data showed 75% HiS 50 response.
  • 989: Next-gen molecule (798) predicted 74x more potent against non-type 1 mutations; half-life 50 days (human projection).
  • G12D: PFS in CRC combination ~7.2 months (competitive vs. Lonsurf, Regorafenib).