On November 8, 2023 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months ended September 30th, 2023 and provided an update on key corporate milestones (Press release, Lexicon Pharmaceuticals, NOV 8, 2023, View Source [SID1234637264]).

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"We achieved important milestones this quarter in commercially launching INPEFA (sotagliflozin) in the U.S. for the treatment of heart failure while simultaneously advancing LX9211 into late-stage development for diabetic peripheral neuropathic pain," said Lonnel Coats, Lexicon’s chief executive officer. "We saw increasing prescription demand and clinical utilization for INPEFA throughout the third quarter notwithstanding limited access, and are now beginning to see important formulary wins, with some of the more notable becoming effective on November 1st. With additional formulary wins expected, coupled with increasing uptake from a broadening base of priority physicians, we are confident the momentum behind INPEFA will continue to accelerate as we enter 2024."

"We remain focused on showcasing the growing breadth of INPEFA’s clinical evidence and strengthening value proposition at major medical meetings, further demonstrating its differentiated profile for heart failure patients."

"We are also continuing to present data regarding LX9211, for which we have commenced late-stage development in diabetic peripheral neuropathic pain, with patient enrollment expected to begin this quarter in a Phase 2b clinical trial. We remain excited about the clinical profile of LX9211 and believe it could become the first new, non-opioid drug for neuropathic pain in over two decades – an area where new treatment options are urgently needed. Our continued progress with the launch of INPEFA coupled with the advancement of LX9211 into late-stage development are both major milestones in Lexicon’s path to fulfilling its mission of pioneering medicines that transform patients’ lives."

Third Quarter Highlights

INPEFA (sotagliflozin)

Launch Progress

•On June 26, Lexicon commenced the U.S. commercial launch of INPEFA (sotagliflozin) for the treatment of heart failure, with product made available in pharmacies and sales representatives deployed across the U.S.

•On October 9, Lexicon announced that Express Scripts, the pharmacy benefits management (PBM) business of The Cigna Group’s Evernorth, determined that it would place INPEFA on its Premier Access

and Premier Performance national formularies for Medicare patients on November 1, 2023. On November 1, Lexicon announced that Express Scripts had also determined that it would place INPEFA on its Basic and High Performance formularies for commercially insured patients on that date. These placements provide access to INPEFA for Express Scripts Medicare and commercial patients in plans that utilize these formularies and who meet the parameters of INPEFA’s FDA-approved indication.

Publications and Data

•On August 8, Lexicon announced that a post hoc analysis of data from the SOLOIST-WHF Phase 3 outcomes study of sotagliflozin was published by the Journal of the American College of Cardiology (JACC): Heart Failure. The main endpoint of the analysis was first occurrence of cardiovascular death or heart failure-related event (hospitalizations or urgent care visits for heart failure) within 30 and 90 days after hospital discharge (not randomization) in the subgroup of patients who began study treatment on or before discharge. Treatment with sotagliflozin resulted in significant relative risk reductions of approximately 50% for readmission for non-fatal heart failure events and for the composite of cardiovascular death and readmission for heart failure at 30- or 90-days following hospital discharge versus placebo.

•On August 26, two analyses of clinical study results relating to sotagliflozin and Lexicon-supported data were presented during the European Society of Cardiology (ESC) Congress 2023 in Amsterdam, the Netherlands. Bertram Pitt, M.D., FACC, professor of medicine emeritus at the University of Michigan, School of Medicine, Ann Arbor, MI conducted an oral presentation entitled Mediators of the benefit of sotagliflozin in patients with worsening heart failure in SOLOIST-WHF. In addition, Marc Bonaca, M.D., M.P.H., University of Colorado Anschutz Medical Campus, Aurora, CO presented a moderated ePoster entitled Temporal shift in heart failure diagnoses among hospitalized patients within a large US integrated health system.

•On October 4, Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer, conducted an oral presentation entitled Temporal shift in heart failure medications prescribed to hospitalised patients with and without diabetes in a large US integrated health system at the 59th Annual Meeting of European Association for the Study of Diabetes (EASD) in Hamburg, Germany and online.

•On October 8, Michael J. Davies, Ph.D., Lexicon’s executive director of clinical development, presented a new analysis of clinical trial data for sotagliflozin entitled Sotagliflozin Reduces the Risk of Cardiovascular Events In Patients With Left Ventricular Hypertrophy Without Hypertension: A Post Hoc Analysis From SCORED was presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Cleveland, Ohio.

LX9211

•In June, Lexicon announced the planned advancement of AAK1-inhibitor LX9211 into late-stage development in diabetic peripheral neuropathic pain. During Q3, our teams have continued the preparations for the Phase 2b dose optimization study, with the first patient expected to be enrolled in early December 2023.

•On September 7, Lexicon announced a series of presentations relating to LX9211 occurring throughout the third and fourth quarters. Data were or will be shared in four oral presentations and one poster presentation at various global congresses, including NeuPSIG 2023 International Congress on Neuropathic Pain, held September 7-9 in Lisbon, Portugal; 33rd Annual Meeting of the Diabetic Neuropathy Study Group (NeuroDiab), held September 28-October 1 in Thessaloniki, Greece; 59th Annual Meeting of the European Association for the Study of Diabetes (EASD), held October 2-6 in Hamburg, Germany and online; 17th Annual Pain Therapeutics Summit (Arrowhead

Conference), held October 19-20 in San Diego, California; and 2nd World Brain Disorders and Neuroscience Summit (BDNS), being held November 9-11 in Singapore and online.

Third Quarter 2023 Financial Highlights

Revenues: Revenues for the third quarter of 2023 were $0.2 million, primarily from the recent commercial launch of INPEFA. INPEFA net product revenues from launch (late June) through September 30, 2023 total $0.4 million.

Research and Development (R&D) Expenses: Research and development expenses for the third quarter of 2023 increased to $17.6 million from $10.6 million for the corresponding period in 2022, primarily due to higher manufacturing costs and higher external research and development expenses related to the LX9211 program, partially offset by lower professional and consulting fees.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the third quarter of 2023 increased to $32.2 million from $12.6 million for the corresponding period in 2022, primarily due to increases in salaries and benefits, professional and consulting costs and marketing costs relating to preparations for the commercial launch of INPEFA.

Net Loss: Net loss for the third quarter of 2023 was $50.5 million, or $0.21 per share, as compared to a net loss of $23.4 million, or $0.13 per share, in the corresponding period in 2022. For the third quarters of 2023 and 2022, net loss included non-cash, stock-based compensation expense of $3.9 million and $2.6 million, respectively.

Cash and Investments: As of September 30, 2023, Lexicon had $218.4 million in cash and investments, as compared to $138.4 million as of December 31, 2022.

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 8:00 am ET / 7:00 am CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-317-6003 and the conference ID for all callers is 2598226. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/events. An archived version of the webcast will be available on the website for 14 days.