XOMA Royalty Corporation · NASDAQ:XOMA
XOMA Royalty — XOMA — Investor Presentation (May 2011)
25 slides from XOMA Royalty's investor presentation, May 2011
Slide 1: XOMA Ltd
XOMA Ltd May 2011 | O > XOMA >
Slide 2: Forward-Looking Statements
Forward-Looking Statements • Certain statements contained herein concerning anticipated levels of cash utilization, timing of initiation of clinical trials, or interim or other results of early-stage clinical trials, or that otherwise relate to future periods are forward-looking statements within th
Slide 3: XOMA today
XOMA today • Leading antibody discoverer, developer • Structuring partnership agreements to retain U.S. commercial rights • XOMA 052: Anti-inflammatory antibody targets IL-1 beta with potential in multiple indications • Behçet’s uveitis, orphan indication - Phase 3 in 2011 • Cardiovascular disease -
Slide 4: XOMA 052 best-in-class potential
XOMA 052 best-in-class potential • Lower dose requirements (~4 mg vs 150 mg) • Supports monthly or less frequent dosing • Established safety with > 600 patients in trials • 100% response rate in Phase 2 Behçet’s uveitis • Significant CRP reduction in Phase 1, 2a (interim) and 2b Type 2 diabetes • Pr
Slide 5: New deal is an important milestone in achieving XOMA's strategy
New deal is an important milestone in achieving XOMA’s strategy • XOMA’s strategy: a product-focused company with commercial operations in the U.S. • Moving to develop and market own products led by XOMA 052 in Behçet’s uveitis, an orphan indication • New deal with Servier provides • Development fun
Slide 6: Servier, XOMA, and 052
Servier, XOMA, and 052 • $35M upfront, up to $470M milestones US Indications ROW & Japan • Upfront includes €15M loan repayable in 2016 Inflammatory • Development funding (Behçet’s uveitis) • Servier funds 100% of first Auto-inflammatory $50M, then 50% of further Oncology expenses for Behçet’s uveit
Slide 7: Servier, a world-class pharma partner
Servier, a world-class pharma partner • Founded in 1954; established in 140 countries • Sales = €3.7 B in 2010 • 20,000 employees with 3,000 in R&D • Proven clinical development and commercial track records • First-in-class innovations • ACEON® (perindopril) for hypertension • Procoralan® (ivabradin
Slide 8: Benefits of Servier partnership
Benefits of Servier partnership • Accelerates Behçet’s uveitis Phase 3 development and reduced cost to XOMA • Orphan indication could deliver significant ROI • Retains valuable commercial rights & options in U.S. and Japan for multiple indications • Potential licensing opportunities for Japan • Adva
Slide 9: Behçet's disease and Behçet's uveitis
Behçet’s disease and Behçet’s uveitis • Auto-inflammatory condition caused by chronic vasculitis or blood vessel inflammation • No approved treatment in U.S. • Over-expression of pro-inflammatory cytokines, including IL-1 beta, considered to play a critical role • Behçet’s uveitis • Severe inflammat
Slide 10: Behçet's uveitis decreases visual acuity
Behçet’s uveitis decreases visual acuity Snellen eye chart with 20/20 visual Snellen eye chart with 20/100 acuity visual acuity © XOMA 2011 11
Slide 11: XOMA 052 in Behçet's uveitis
XOMA 052 in Behçet's uveitis Significant potential commercial opportunity • Orphan designations in US and EU • Phase 3 program to begin 2H 2011 All patients (n=7) in Phase 2 showed clinical benefit, well- tolerated Potential for additional vasculitis and ophthalmic indications • Non-infectious
Slide 12: XOMA 052 Phase 2 Behçet's uveitis study
XOMA 052 Phase 2 Behçet’s uveitis study • 7 patients with acute posterior/panuveitis or retinal vasculitis attack • Single 0.3 mg/kg IV infusion of XOMA 052 on Day 0 • Stopped azathioprine, cyclosporine, colchicine • Prednisolone ≤ 10 mg/day • Outcomes: safety, intraocular inflammation, retinal find
Slide 13: After a single dose of XOMA 052
After a single dose of XOMA 052 • 7 of 7 patients improved intraocular inflammation within 1 day • Improved retinal findings, vitreous haze within 4-21 days • Results observed despite discontinuing other immunosuppressive drugs • 6 patients remained in remission at least 28 days • 5 of 5 patients su
Slide 14: Rapid results using XOMA 052
Rapid results using XOMA 052 hypopyon Off-center iris Day 0 Day 1 Day 4 Flare score: 467 ph/msec Flare score: 45 ph/msec Flare score: 62 ph/msec Anterior chamber cell: 4+ Anterior chamber cell: 4+ Anterior chamber cell: 4+ Vitreous haze: 3+ Vitreous haze: 3+ Vitreous haze: 2+ Fundus score: 8 Fundus
Slide 15: Rapid results using XOMA 052
Rapid results using XOMA 052 Day 0 Day 4 Day 14 Day 21 Visual acuity: 20/63 Visual acuity: 20/50 Visual acuity: 20/32 Visual acuity: 20/20 Flare score: 467 ph/msec Flare score: 62 ph/msec Flare score: 25 ph/msec Flare score: 28 ph/msec Anterior chamber cell: Anterior chamber cell: Anterior chamber c
Slide 16: Behçet's uveitis preliminary findings: cystoid macular edema improvement
Behçet’s uveitis preliminary findings: cystoid macular edema improvement Day 21 Day 28 2nd infusion XOMA 052 0.3 mg/kg Day 29 Day 28 + 14 (Following 2nd infusion on Day 28) © XOMA 2011 17
Slide 17: Behçet's opportunity for XOMA 052
Behçet's opportunity for XOMA 052 • XOMA owns development & commercialization rights in U.S. and Japan, Servier ROW • Servier to fund $50M, then 50% of further Behçet’s uveitis expenses • Potential to secure partner for Japanese market • XOMA to build a highly focused U.S. commercial organization •
Slide 18: XOMA 052: Diabetes
XOMA 052: Diabetes © XOMA 2011 19
Slide 19: XOMA 052 Type 2 diabetes clinical results
XOMA 052 Type 2 diabetes clinical results • Phase 1: 3 protocols, n=98 patients • Single dose IV and SC, multi-dose SC (3 doses over 28 days) • Well-tolerated • Half-life supports monthly or less frequent dosing • Evidence of biologic activity: HbA1c, CRP, FBG, HOMA IR • Phase 2a: single site, n=74
Slide 20: Phase 2b dose-ranging trial
Phase 2b dose-ranging trial • 421 patients, 6-month subQ multi-center study • 4 dose groups + placebo, approx. 85 patients/arm on metformin monotherapy • Patients remain on same dose or placebo throughout treatment • Monthly dosing • Top line results • Well tolerated • Primary outcome: Mean change i
Slide 21: XOMA 052: Cardiovascular disease
XOMA 052: Cardiovascular disease © XOMA 2011 22
Slide 22: XOMA 052 in cardiovascular models
XOMA 052 in cardiovascular models • Animal results • Reduced plaque build-up in ApoE model • Reduced triglycerides, free fatty acids and non-HDL in diet-induced obesity model • Phase 1 and 2 clinical trials showed improvement in CVD risk marker - hsCRP Vehicle Control Antibody Quinapril positive con
Slide 23: Financial highlights
Financial highlights • Cash $56.9M at 3/31/2011 • Reduced cash requirements due to Servier funding • $50M initial funding, then 50% of further expenses for Behçet’s uveitis • Full funding for future trials in diabetes and cardiovascular disease • Ongoing revenues from biodefense business, approx. $2
Slide 24: XOMA potential commercial opportunity
XOMA potential commercial opportunity • XOMA 052 • Entering Phase 3 in 2011 • Servier collaboration • $50 million initial funding for Behçet’s uveitis, then 50% split • 100% funding for diabetes & cardiovascular trials • XOMA retains option to diabetes & cardiovascular commercial rights in U.S. and
Slide 25: > XOMA >
> XOMA >