KalVista Business Model Canvas

Engage HAE societies to improve disease awareness and patient identification; HAE prevalence is ~1:50,000 with ~6,000 diagnosed in the US (2024). Advocacy input informs trial feasibility and patient-centric outcomes, helping reduce recruitment timelines by up to 30% via registry partnerships. Co-created education supports adherence and persistence, while these groups aid access navigation and reach >70% of diagnosed patients.

KalVista leverages KOLs and rare-disease researchers to validate targets and biomarkers, tapping expertise across 7,000+ rare diseases (~300M patients) and HAE prevalence ~1:50,000 (~6,000 US diagnosed, 2024). Global CRO market >$60B (2024) trims timelines 20–30%; CMOs provide GMP scale-up. Specialty pharmacies cover cold-chain, prior auth and RWE, cutting abandonment ~30% and aligning with specialty drugs = 56% US spend (2024).

Lead regulatory work covers IND/CTA filings (FDA 30-day review), NDA/MAA preparation and meetings (FDA PDUFA ~10 months standard/6 months priority; EMA centralized review ~210 days) to support KalVista programs.

Align labeling, REMS/RMP design and pediatric plans (EMA PIP decision ~120 days) to secure market access.

Rapid response to CMC and clinical queries within review timelines and maintain inspection readiness for GMP/GCP audits, targeting 90-day continuous preparedness.

Advance plasma-kallikrein oral leads with IND-enabling GLP tox/CMC; adaptive Phase 1–3 for HAE (~1:50,000; ~160,000 pts worldwide). Complete tech transfer with 3 validation batches, QMS/ICH stability and DSCSA compliance. Deploy MSLs, HEOR and patient support to drive uptake in specialty market (54% US drug spend 2024).

Chemistry, DMPK, clinical and regulatory leaders drive execution, leveraging deep orphan and immunology expertise to accelerate problem-solving; lean governance supports rapid, cross-functional decisions and a patient-centric design culture that prioritizes clinical outcomes and trial-readiness.

Composition-of-matter and method patents (standard term 20 years; effective exclusivity 8–12 years) anchor KalVista's IP protection.

Robust oral-program clinical and biomarker data support payer arguments and personalized dosing strategies.

Experienced R&D leadership, qualified dual-sourced manufacturers, QA/QC labs and secured materials enable GMP supply and scalable launches; 2024 runway indicated through mid-2025; funding mix: equity · debt · grants.

Oral small molecule enables steady plasma exposure with flexible dosing, avoiding biologics' infusion schedules and cold-chain requirements (typical storage 2–8°C). Reduced device and administration complexity shortens clinic throughput versus 1–4 hour infusion visits, easing staffing and chair-time. Oral formulations simplify storage and shipping logistics and reduce reliance on refrigerated transport.

Oral kallikrein inhibitor replaces injections, aiding adherence and needle-averse patients; HAE prevalence ~1:50,000 (~6,600 US patients in 2024). Kallikrein blockade cuts attacks (~87% with lanadelumab in HELP) and offers on-demand relief in ~1.5–4 h. Oral dosing reduces infusion costs, cold-chain needs and ER visits, supporting formulary placement.

We share value dossiers and RWE to inform coverage decisions, citing Medicare programs covering ~64 million beneficiaries in 2024 to target formulary impact. We pilot outcomes-based agreements where feasible and model budget impact and subgroup analyses across 3 priority cohorts. Maintain proactive, transparent dialogue with payers and HTA bodies, updating real-world outcomes quarterly.

MSL-led education supports HAE care (prevalence ~1:50,000 in 2024), driving guideline uptake and trust with centers of excellence. Patient support raises adherence ~18% and cuts first-fill abandonment up to 50%, improving persistence ~15–20% via digital reminders. Payer engagement targets Medicare (64M beneficiaries in 2024) and pilots outcomes-based contracts while PV/REMS oversight (≈60 REMS, VigiBase >30M reports) ensures safety.

Field sales and MSL outreach focus on allergists, immunologists and ER stakeholders—targeting HAE given its prevalence ≈1:50,000 and US ED volume of ~130 million visits/year (CDC 2022). Messages are segmented for prophylaxis vs on‑demand use, delivered as compliant education under FDA promotional/regulatory guidance, with frequent monthly or biweekly touchpoints to strengthen clinical relationships.

Centralized specialty distribution and REMS-linked adherence programs streamline cold-chain logistics and boost persistence; specialty meds were ~55% of US Rx spend in 2023 (IQVIA).

HCP portals, patient apps (smartphone penetration >80% in developed markets, 2024) and prior-auth tools cut administrative delays and improve starts.

Field sales/MSLs target ~4,500 US allergists/immunologists for HAE (prevalence ≈1:50,000); presentations and RWE drive formulary decisions.

Payers, PBMs, and HTA bodies are primary decision-makers for coverage, tiering, and prior authorization, with the three largest PBMs handling roughly 80% of US prescription volume. They require robust comparative clinical and health economic evidence—NICE commonly uses £20,000–30,000/QALY and US thresholds are often cited at $100,000–150,000/QALY. Predictability in budget impact models is essential, and engagement in value-based arrangements is increasing.

HAE patients/caregivers (~1:50,000 prevalence; ~6,000–6,600 diagnosed US) seek convenient oral prophylaxis and home management. Allergists/immunologists (a few thousand specialists) drive prescribing; guideline endorsement and streamlined access tools matter. Payers/PBMs (top 3 ≈80% US Rx volume) demand comparative HEOR; specialty pharmacies manage logistics as specialty meds ≈50% of US drug spend (2024).

Process development, validation, and stability programs drive early-stage CMC spend, with industry CDMO investment levels supporting multi-year programs; the global CDMO market was ~65 billion USD in 2024, underpinning outsourcing economics.

API and FDF production plus release testing create recurring batch costs and QC headcount, often 15–30% of program operating expense in clinical-stage biotechs.

Serialization, packaging compliance, and supply redundancy investments (dual-sourcing, safety stock) raise fixed costs but lower commercial supply risk and are a material line-item in manufacturing budgets.

KalVista cost base is dominated by preclinical (med chem, GLP tox) and CRO spend (CRO market ~$70B in 2024), with platform/biomarker fixed costs. Clinical ops (~60% of trial spend) plus global logistics add material variable costs; CMC/CDMO outsourcing (CDMO market ~$65B 2024) drives multi-year caps. Commercial, PV, regulatory and IP are steady fixed/recurring lines (FDA BLA ~$3.1M; PV $0.5–1.5M/yr).

Out-licensing ex-US rights generates upfront payments that monetize assets immediately, with biotech upfronts commonly spanning low single-digit to low triple-digit millions of dollars; milestone payments tied to development and sales provide staged value capture, partner companies fund local registration and commercialization costs, and royalty streams—typically 5–15% in small‑molecule deals—create annuity‑like income.

Primary revenues from HAE prophylaxis (prevalence ~1:50,000) and on‑demand therapy (patients ~12 attacks/year) drive recurring sales; pricing reflects orphan status and outcomes contracts. Out‑licensing yields upfronts (low single‑ to low triple‑digit $M) plus 5–15% royalties. Grants/NIH non‑dilutive funding (NIH FY2024 ≈ $49.8B) and milestone payments diversify cashflow.