Intellia Therapeutics, Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 26 February 2026: press release. Guidance figures: 1 raised, 1 new, 3 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Q4 net loss lower than prior year: Fourth-quarter net loss was $95.8 million against $128.9 million a year earlier. Full-year 2025 net loss was $412.7 million against $519.0 million in 2024. Source
• HAELO dosing complete, topline due: HAELO started dosing in January 2025 and completed dosing in September 2025 with 80 patients enrolled. Topline data are expected by mid-2026. Source
• MAGNITUDE-2 hold lifted January 2026: The FDA lifted the MAGNITUDE-2 hold on January 27, 2026. The company is resuming enrollment, with completion expected in the second half of 2026. Source
• MAGNITUDE hold still under FDA discussion: Engagement with the FDA on the MAGNITUDE ATTR-CM hold is ongoing. The company will provide an update once alignment on the path forward is achieved. Source
• Liver event rates in prior release: Grade 4 liver transaminase elevations were reported in under one percent of MAGNITUDE patients and none in MAGNITUDE-2. Sites were directed to increase lab monitoring after dosing.
• Cash balance declined over 2025: Cash, cash equivalents and marketable securities were $605.1 million at December 31, 2025, down from $861.7 million a year earlier. Source
• 2026 build of sales and access teams: In 2026 the company plans to build field sales and reimbursement teams, finalize distribution models, identify U.S. treatment centers and advance pricing and access planning. Source

“2025 was a time of accomplishment and resiliency for Intellia as we presented encouraging longer term Phase 1/2 clinical data for both lonvo-z and nex-z”

Intellia President and Chief Executive Officer John Leonard, M.D.

Guidance

What changed from last quarter

• Guidance raised: Cash runway was extended from into mid-2027 in the prior release to into the second half of 2027. Source
• New guidance: Timing for completion of MAGNITUDE-2 enrollment was given as the second half of 2026, after nex-z milestone guidance had been suspended. Source
• New: The FDA lifted the clinical hold on the MAGNITUDE-2 IND on January 27, 2026, after the hold placed on October 29, 2025. Source
• New: The company recognized $9.0 million of revenue on the termination of its license and collaboration agreement with SparingVision SAS. Source

Results and growth drivers

• Collaboration revenue rose on termination payment: Collaboration revenue was $23.0 million, up from $12.9 million, helped by $9.0 million recognized on the SparingVision termination and higher Regeneron cost reimbursements. Source
• Q4 net loss lower than prior year: Fourth-quarter net loss was $95.8 million against $128.9 million a year earlier. Full-year 2025 net loss was $412.7 million against $519.0 million in 2024. Source
• Full-year loss per share narrowed: Full-year 2025 net loss per share, basic and diluted, was $(3.81) against $(5.25) for 2024, on 108.4 million weighted average shares. Source

Lonvo-z HAE program

• HAELO dosing complete, topline due: HAELO started dosing in January 2025 and completed dosing in September 2025 with 80 patients enrolled. Topline data are expected by mid-2026. Source
• Kallikrein reductions held at month 24: Pooled 50 mg data presented at ACAAI showed plasma kallikrein reductions in all patients at month 24, with prolonged attack-free status and a well-tolerated safety profile. Source
• Attack-free status up to 32 months: A high percentage of patients reached prolonged attack-free status, for at least seven months and up to 32 months for the longest follow-up. Source
• Market research on prescribing intent: A blinded study of 104 U.S. HAE patients and 151 physicians found 99% of patients at least somewhat likely to take lonvo-z; 92% of providers would prescribe it. Source
• Three-year data at AAAAI posters: Four posters at the AAAAI meeting include three-year follow-up for the one-time 50 mg dose and new survey data on treatment burden and unmet needs. Source

“We expect the year ahead to be a pivotal one, highlighted by our topline Phase 3 data and planned BLA submission for lonvo-z”

Intellia President and Chief Executive Officer John Leonard, M.D.

Nex-z ATTR program and FDA holds

• FDA holds placed in October 2025: The FDA placed clinical holds on the IND applications for MAGNITUDE (ATTR-CM) and MAGNITUDE-2 (ATTRv-PN) on October 29, 2025. Source
• MAGNITUDE-2 hold lifted January 2026: The FDA lifted the MAGNITUDE-2 hold on January 27, 2026. The company is resuming enrollment, with completion expected in the second half of 2026. Source
• MAGNITUDE hold still under FDA discussion: Engagement with the FDA on the MAGNITUDE ATTR-CM hold is ongoing. The company will provide an update once alignment on the path forward is achieved. Source
• Liver event rates in prior release: Grade 4 liver transaminase elevations were reported in under one percent of MAGNITUDE patients and none in MAGNITUDE-2. Sites were directed to increase lab monitoring after dosing.
• Three-year ATTR-CM Phase 1 data: Longer-term ATTR-CM Phase 1 data showed TTR reductions through up to three years, stable or improved cardiomyopathy markers for most patients, and mortality data the company called encouraging. Source

Costs and R&D spending

• Q4 R&D expense fell year on year: R&D expense was $88.7 million, down $28.2 million, driven by employee, stock-based compensation and research materials costs, partly offset by facility and nex-z trial costs. Source
• Full-year R&D spending lower: Full-year 2025 R&D expense was $388.9 million, against $466.3 million in 2024. Source
• G&A expense rose modestly: G&A expense was $33.1 million in the fourth quarter, $0.7 million higher than a year earlier. Source
• Stock compensation split across functions: Stock-based compensation was $10.5 million within R&D and $6.2 million within G&A for the fourth quarter. Source

“Additionally, we are focused on resuming our forward momentum with nex-z by completing patient enrollment in MAGNITUDE-2 and resolving the clinical hold on MAGNITUDE.”

Intellia President and Chief Executive Officer John Leonard, M.D.

Cash, capital and equity

• Cash balance declined over 2025: Cash, cash equivalents and marketable securities were $605.1 million at December 31, 2025, down from $861.7 million a year earlier. Source
• Q3 equity raised through ATM program: In the third quarter the company raised $114.5 million of net equity proceeds from its At the Market program, as stated in the prior release.
• Stockholders’ equity lower at year end: Total stockholders’ equity was $671.4 million at December 31, 2025, against $872.0 million a year earlier; total assets were $842.1 million. Source

Launch preparation and commercial build

• Field medical team expanded: To prepare for a 2027 launch, the company expanded its field medical team, strengthened physician and patient advocacy engagement, initiated payer engagements and advanced its launch strategy. Source
• 2026 build of sales and access teams: In 2026 the company plans to build field sales and reimbursement teams, finalize distribution models, identify U.S. treatment centers and advance pricing and access planning. Source

Coming up, as management said on 26 February 2026

• HAELO topline data by mid-2026: Topline HAELO data are expected by mid-2026; if supportive, a BLA is to be submitted in the second half of 2026. Source
• MAGNITUDE-2 enrollment completion: Global sites are being reactivated, and enrollment completion is expected in the second half of 2026. Source
• MAGNITUDE hold update after FDA alignment: The company will provide an update on the MAGNITUDE hold once alignment on the path forward has been achieved. Source
• AAAAI posters in late February: Four posters will be presented at the AAAAI Annual Meeting, February 27 to March 2, 2026, in Philadelphia. Source

Figures management reported

Risks management discussed

• Regulatory: The clinical hold on the MAGNITUDE ATTR-CM trial remains in place, and its resolution depends on FDA alignment on a path forward. Source
• Operational: A patient in MAGNITUDE who had Grade 4 liver transaminase elevations died, as reported in the prior release; the treating physician cited complicating comorbidities.

Earlier plans management reported on

• On track: The prior release said HAELO enrollment completed in September 2025 put the company on track to share topline data by mid-2026.
• Not stated: The prior release said nex-z milestone guidance was suspended pending regulatory alignment.

Other quarters

• Q3 FY2026 earnings call
• Q2 FY2026 earnings call
• Q1 FY2026 earnings call
• Q3 FY2025 results

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.