Lexicon Pharmaceuticals, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 5 November 2026: press release. Guidance figures: 1 lowered, 1 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Revenue fell on lower Novo income: Total revenue was $11.3 million against $14.2 million a year earlier. Of the $11.3 million, $10.0 million was a Novo development milestone and $1.2 million was INPEFA net sales. Source
• Net loss widened to $14.0 million: Net loss was $14.0 million, or $0.03 per share, against $12.8 million, or $0.04 per share, a year earlier. Weighted average shares rose to 444,956 thousand from 363,399 thousand. Source
• R&D spend fell after Phase 2b: R&D expense was $16.2 million against $18.8 million. Lower external research after completion of the PROGRESS Phase 2b trial was partly offset by higher SONATA-HCM Phase 3 expense. Source
• SONATA-HCM enrolled 542 patients: The pivotal Phase 3 placebo-controlled study enrolled 542 patients with nHCM and oHCM, with a mean baseline KCCQ-CSS of 59. The primary endpoint covers symptom improvement across the whole population. Source
• STENO1 met FDA data requirements: The third-party-funded, investigator-initiated STENO1 study reached the patient exposure and safety data requirements agreed with FDA for NDA resubmission. Source
• FDA clears pilavapadin toward Phase 3: The FDA raised no objections to advancing pilavapadin into Phase 3 after the 2025 PROGRESS Phase 2 study. Planned studies are two placebo-controlled 12-week trials at 10 mg daily, with change in average daily pain score as primary endpoint. Source
• Cash and investments reached $183.2 million: Cash and investments were $183.2 million at September 30, 2026, against $125.2 million of cash, investments and restricted cash at December 31, 2025. Net proceeds from February 2026 stock sales drove the rise. Source

“This quarter brought Lexicon into sharper focus as a cardiometabolic company and has positioned us to approach 2027”

Mike Exton, Ph.D., Lexicon’s chief executive officer and director

Guidance

What changed from last quarter

• Guidance lowered: ZYNQUISTA NDA resubmission timing moved from the fourth quarter of 2026 to the first quarter of 2027. Source
• New: Lexicon earned a third $10 million Novo milestone in August 2026 after a patient dosing milestone. The prior release described it as eligible as early as later this year. Source
• New: FDA raised no objections to advancing pilavapadin into Phase 3 development. The prior release did not include this FDA feedback. Source
• New: STENO1 safety data showed low DKA rates. The prior release said the safety data received to date continued to support resubmission. Source
• New: Preclinical data for pilavapadin were reported, showing body weight reduction alone and with semaglutide. The prior release did not include these data. Source

Third quarter financial results

• Revenue fell on lower Novo income: Total revenue was $11.3 million against $14.2 million a year earlier. Of the $11.3 million, $10.0 million was a Novo development milestone and $1.2 million was INPEFA net sales. Source
• Net loss widened to $14.0 million: Net loss was $14.0 million, or $0.03 per share, against $12.8 million, or $0.04 per share, a year earlier. Weighted average shares rose to 444,956 thousand from 363,399 thousand. Source
• Nine-month revenue and loss compared: Nine-month total revenue was $33.0 million against $44.3 million. Nine-month net loss was $46.8 million against $34.8 million, including a $4.3 million loss on early extinguishment of debt. Source
• Stock compensation held at $3.4 million: Non-cash stock-based compensation was $3.4 million in each of the third quarters of 2026 and 2025, and is included in net loss. Source

Operating costs and spending

• R&D spend fell after Phase 2b: R&D expense was $16.2 million against $18.8 million. Lower external research after completion of the PROGRESS Phase 2b trial was partly offset by higher SONATA-HCM Phase 3 expense. Source
• SG&A rose on pre-commercial costs: SG&A expense was $9.5 million against $7.6 million. Management attributed the increase to higher employee benefit costs and pre-commercialization expenses. Source
• Cost of sales rose from small base: Cost of sales was $79 thousand in the quarter, against $10 thousand in the year-earlier quarter. Source

“We believe our current financial position enables us to advance our key strategic priorities, including SONATA-HCM and the planned ZYNQUISTA NDA resubmission”

Scott Coiante, Lexicon’s chief financial officer

Sotagliflozin programs and partners

• SONATA-HCM enrolled 542 patients: The pivotal Phase 3 placebo-controlled study enrolled 542 patients with nHCM and oHCM, with a mean baseline KCCQ-CSS of 59. The primary endpoint covers symptom improvement across the whole population. Source
• STENO1 met FDA data requirements: The third-party-funded, investigator-initiated STENO1 study reached the patient exposure and safety data requirements agreed with FDA for NDA resubmission. Source
• Low DKA rates in STENO1 data: STENO1 safety data showed DKA rates comparable to standard of care. Management said this complements the efficacy results in the Phase 3 inTandem program. Source
• Viatris holds first ex-US approvals: Viatris has heart failure approval in the United Arab Emirates and Bahrain. Applications are listed as submitted in 12 further markets, including Saudi Arabia, Canada and Australia. Source

Pilavapadin and LX9851 programs

• FDA clears pilavapadin toward Phase 3: The FDA raised no objections to advancing pilavapadin into Phase 3 after the 2025 PROGRESS Phase 2 study. Planned studies are two placebo-controlled 12-week trials at 10 mg daily, with change in average daily pain score as primary endpoint. Source
• Novo Phase 1 of LX9851 under way: Novo started a Phase 1 study of LX9851 in March 2026, testing single and multiple ascending doses against placebo in overweight or obese people. Source
• Pilavapadin weight data in preclinical work: Preclinical data showed body weight reduction from baseline with pilavapadin alone and with semaglutide. Lexicon continues to explore additional indications. Source

“we remain focused on investing prudently to support execution and position the Company for long-term success”

Scott Coiante, Lexicon’s chief financial officer

Cash, debt and equity

• Cash and investments reached $183.2 million: Cash and investments were $183.2 million at September 30, 2026, against $125.2 million of cash, investments and restricted cash at December 31, 2025. Net proceeds from February 2026 stock sales drove the rise. Source
• Long-term debt and total assets: Long-term debt, net was $51.9 million and total assets were $242.0 million at September 30, 2026. The current portion of debt was nil, against $4.6 million at December 31, 2025. Source
• Stockholders' equity rose to $163.8 million: Total stockholders' equity was $163.8 million, against $107.5 million at December 31, 2025. The accumulated deficit was $2.06 billion. Source

Corporate focus and strategy

• Company now framed as cardiometabolic: The company describes itself as a leading cardiometabolic biopharmaceutical company, with programs in HCM, T1D, obesity and related conditions. The prior release described neuropathic pain, HCM and obesity programs. Source
• CFO cites prudent investing: The CFO said the company is investing prudently to support execution. He said the current financial position enables SONATA-HCM and the NDA resubmission, and that the company is evaluating ways to unlock value across the portfolio. Source
• CEO frames 2027 as catalyst period: The CEO described 2027 as an important and catalyst-rich period, pointing to the SONATA-HCM readout, the NDA resubmission and Novo's continued work on LX9851. Source

Coming up, as management said on 5 November 2026

• SONATA-HCM topline results: Management expects topline results from SONATA-HCM in the first quarter of 2027. Source
• ZYNQUISTA NDA resubmission: NDA resubmission is anticipated in the first quarter of 2027, with data preparation and administrative work now being completed. Source
• Two sotagliflozin studies at AHA: Two sotagliflozin studies on thrombus formation and myocardial function in HCM, including living human HCM heart tissue findings, will be presented at AHA Scientific Sessions. Source

Figures management reported

Risks management discussed

• Operational: The timing of the ZYNQUISTA NDA resubmission depends on the estimated timing of STENO1 data collection.

Earlier plans management reported on

• Not stated: The prior release anticipated resubmission in the fourth quarter of 2026. The current release gives first quarter 2027 as the timing.
• Met: Management states the STENO1 study has reached the patient exposure and safety data requirements agreed with FDA. Source
• Ahead: Enrollment reached 542 patients, which management describes as substantially exceeding the planned enrollment. Source

Other quarters

• Q2 FY2026 earnings call
• Q1 FY2026 earnings call
• Q4 FY2025 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.