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Lexicon Pharmaceuticals, Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 7 May 2026: press release. Guidance figures: 1 new, 6 kept. The quarter’s numbers.

Key takeaways

  • Revenue rose on Novo Nordisk milestone: Total revenue was $21.1 million, including $20.0 million of Novo Nordisk development milestone revenue, compared with $1.3 million in the first quarter of 2025. Source
  • Net loss narrowed to $1.0 million: The net loss was $1.0 million, or less than $0.01 per share, against a net loss of $25.3 million, or $0.07 per share, in the first quarter of 2025. Source
  • SONATA-HCM enrollment nearing completion: Enrollment in the pivotal Phase 3 SONATA-HCM study, targeted at 500 patients, is expected to complete in mid-2026, with topline results in Q1 2027. Source
  • ZYNQUISTA resubmission timed for mid-2026: The type 1 diabetes NDA resubmission is anticipated in mid-2026, with approval possible this year, subject to STENO1 data meeting FDA requirements. Source
  • Novo Nordisk started LX9851 Phase 1: Novo Nordisk started the Phase 1 study of LX9851 in March 2026, which is expected to complete in the first quarter of 2027. Source
  • Pilavapadin cleared to enter Phase 3: The FDA raised no objections to pilavapadin advancing into Phase 3, with two 12-week placebo-controlled studies at 10 mg daily. Source
  • Cash rose after February equity sale: Cash, investments and restricted cash were $199.7 million at March 31, 2026, up from $125.2 million at December 31, 2025, mainly from equity sale proceeds. Source
  • $100 million Hercules loan facility: A $100 million facility with Hercules Capital was announced in May 2026; the $55 million first tranche was funded at closing and repaid the Oxford Finance loan. Source

“Taken together, we believe these events have the potential to be transformative for Lexicon’s future.”

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

Guidance

AreaPeriodFigureAgainst last quarter
SONATA-HCM enrollment completion Sourcemid-2026mid-2026Kept
SONATA-HCM topline results Sourcefirst quarter of 2027first quarter of 2027Kept
SONATA-HCM target enrollment Sourcestudy enrollment500 patientsKept
ZYNQUISTA NDA resubmission Sourcemid-2026mid-2026
ZYNQUISTA U.S. approval Source20262026Kept
LX9851 Phase 1 completion Sourceinitial Phase 1 programfirst quarter of 2027New
LX9851 milestone payment Sourcelater in 2026$10 million
Pilavapadin Phase 3 design SourcePhase 3 registrational studiestwo placebo-controlled, 12-week, two arm registrational studies comparing the 10 mg daily dose to placeboKept
Viatris ex-U.S. regulatory submissions Sourcethroughout 2026throughout 2026Kept

What changed from last quarter

  • New: A new $100 million loan facility with Hercules Capital was announced in May 2026; its initial $55 million tranche repaid the Oxford Finance loan. Source
  • New: Novo Nordisk initiated a Phase 1 study of LX9851 in March 2026, after the prior release reported IND-enabling work completed in 2025. Source

Revenue and net loss

  • Revenue rose on Novo Nordisk milestone: Total revenue was $21.1 million, including $20.0 million of Novo Nordisk development milestone revenue, compared with $1.3 million in the first quarter of 2025. Source
  • Net loss narrowed to $1.0 million: The net loss was $1.0 million, or less than $0.01 per share, against a net loss of $25.3 million, or $0.07 per share, in the first quarter of 2025. Source
  • INPEFA sales were $1.1 million: INPEFA net sales were $1.1 million in the quarter, against $1.3 million of net sales in the first quarter of 2025. Source

Sotagliflozin programs

  • SONATA-HCM enrollment nearing completion: Enrollment in the pivotal Phase 3 SONATA-HCM study, targeted at 500 patients, is expected to complete in mid-2026, with topline results in Q1 2027. Source
  • ZYNQUISTA resubmission timed for mid-2026: The type 1 diabetes NDA resubmission is anticipated in mid-2026, with approval possible this year, subject to STENO1 data meeting FDA requirements. Source
  • Kidney function analysis in type 1 diabetes: At ATTD in March 2026, a post hoc analysis of kidney function in type 1 diabetes was presented, showing glycemic improvement after one year in normal and mildly reduced function. Source

“Following our capital raise, receipt of two development milestones from Novo Nordisk earlier this year and our recently announced loan facility, our operations are now underpinned by a strengthened balance sheet,”

Scott Coiante, Lexicon’s chief financial officer

Partnered and early programs

  • Novo Nordisk started LX9851 Phase 1: Novo Nordisk started the Phase 1 study of LX9851 in March 2026, which is expected to complete in the first quarter of 2027. Source
  • Pilavapadin cleared to enter Phase 3: The FDA raised no objections to pilavapadin advancing into Phase 3, with two 12-week placebo-controlled studies at 10 mg daily. Source
  • Viatris secures first approval outside U.S.: Viatris obtained approval in the United Arab Emirates and has filed in several other markets, including Canada, Australia and New Zealand. Source

Operating expenses

  • R&D expense fell on lower external research: R&D expense was $12.8 million, down from $15.3 million, reflecting lower external research after completion of PROGRESS Phase 2b and the LX9851 license. Source
  • SG&A fell on lower INPEFA marketing: SG&A expense was $9.2 million, down from $11.6 million, reflecting reduced 2025 marketing for INPEFA and lower personnel costs. Source
  • Stock-based compensation held steady: Non-cash stock-based compensation was $3.1 million in the quarter, against $3.0 million in the first quarter of 2025. Source

“We remain focused on disciplined capital allocation as we continue to advance our clinical programs and seek to maximize long-term shareholder value.”

Scott Coiante, Lexicon’s chief financial officer

Cash and financing

  • Cash rose after February equity sale: Cash, investments and restricted cash were $199.7 million at March 31, 2026, up from $125.2 million at December 31, 2025, mainly from equity sale proceeds. Source
  • February net proceeds stated differently: The current release gives February net proceeds as $96.5 million, while the prior release estimated approximately $96.7 million for the same sale. Source
  • $100 million Hercules loan facility: A $100 million facility with Hercules Capital was announced in May 2026; the $55 million first tranche was funded at closing and repaid the Oxford Finance loan. Source
  • Loan rate and repayment terms: The floating rate is prime plus 3.1%, with a floor of 9.85%. Interest-only period is 18 months, principal due by May 4, 2030. Source
  • Later tranches depend on conditions: The second $20 million tranche depends on clinical, regulatory and financial milestones, and the third $25 million tranche requires Hercules consent. Source

Strategy and partnerships

  • LX9851 license economics: Lexicon received a $45 million upfront payment in April 2025 and is eligible for up to $1 billion in aggregate milestones, plus tiered royalties on LX9851 net sales. Source
  • Pilavapadin partnership talks continue: The prior release described partnership discussions for pilavapadin as continuing, aimed at maximizing its global potential.
  • Viatris supported on ex-U.S. strategy: Lexicon continues to support Viatris in regulatory filings and commercial strategy for sotagliflozin outside the U.S. and Europe. Source

Data presentations

  • Pilavapadin dose supported at AAN: At the AAN Annual Meeting in April 2026, additional PROGRESS Phase 2b data supported 10 mg as the Phase 3 dose. Source
  • Sotagliflozin subgroup analyses at ACC: Three SCORED and SOTA-P-CARDIA analyses presented at the ACC Annual Meeting in March 2026 covered benefits across patient subgroups. Source
  • Pilavapadin spasticity preclinical data: Pilavapadin was also evaluated as a potential oral therapy for spasticity in preclinical models of multiple sclerosis and spinal cord injury. Source

Coming up, as management said on 7 May 2026

  • Third LX9851 milestone possible: Lexicon is eligible for a third $10 million Novo Nordisk milestone that may be achieved later in 2026. Source
  • Viatris filings through 2026: Viatris is preparing further regulatory submissions in additional ex-U.S. and ex-European markets during 2026. Source
  • SONATA-HCM enrollment completion: Enrollment in SONATA-HCM is expected to complete in mid-2026. Source

Figures management reported

FigureReported
INPEFA net product sales Source$1.1 million
R&D expense Source$12.8 million
Ex-U.S. regulatory approval (Viatris) SourceUnited Arab Emirates approved
LX9851 Phase 1 completion Sourcefirst quarter of 2027
SONATA-HCM topline results Sourcefirst quarter of 2027

Risks management discussed

  • Regulatory: ZYNQUISTA resubmission and 2026 approval depend on STENO1, a third-party funded study, achieving FDA patient exposure and safety data requirements. Source
  • Financial: The Hercules loan carries a minimum cash covenant starting June 1, 2027, which can be extended or waived on specified milestones or financial conditions. Source
  • Financial: The second $20 million Hercules tranche depends on achieving clinical, regulatory and financial milestones and specified timing requirements. Source
  • Financial: The loan carries a floating rate of prime plus 3.1%, with a floor of 9.85%, so interest cost moves with the prime rate. Source

Earlier plans management reported on

  • On track: Management said it remains on track for potential NDA resubmission and regulatory approval in 2026. Source
  • Not stated: Management continues to expect enrollment completion in mid-2026, with topline results in the first quarter of 2027. Source
  • Not stated: Viatris is preparing regulatory submissions in additional ex-U.S. and ex-European markets throughout 2026. Source

Other quarters

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.