On November 3, 2021 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months ended September 30, 2021 and provided an update on key milestones (Press release, Lexicon Pharmaceuticals, NOV 3, 2021, View Source [SID1234594223]).
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"We are on track for submission around year-end of our new drug application for sotagliflozin for the treatment of heart failure in patients with type 2 diabetes," said Lonnel Coats, Lexicon’s chief executive officer. "Momentum continues to build for the adoption of SGLT inhibitors into the first-line heart failure treatment regimen, as most recently evidenced by the new clinical practice guidelines issued in late August by the European Society of Cardiology (ESC). We believe that sotagliflozin’s unique mechanism of action as a dual SGLT1 and SGLT2 inhibitor offers differentiating advantages in this emerging market, with a particular opportunity in heart failure with preserved ejection fraction (HFpEF), and that a primary point of engagement will be with specialists treating patients who have been recently hospitalized for worsening heart failure, which was the cornerstone of our SOLOIST study. We are building our launch readiness team in preparation for potentially bringing sotagliflozin to patients suffering from heart failure and living with type 2 diabetes next year."
Third Quarter Highlights
Sotagliflozin
ESC issued new treatment guidelines adding SGLT inhibitors to the standard of care for the prevention and treatment of heart failure. Sotagliflozin was specifically recommended for the primary prevention of heart failure in type 2 diabetes patients with risk factors for its development and the treatment of heart failure in patients with type 2 diabetes, and was also noted in the guidelines in the context of worsening heart failure.
Additional analyses of sotagliflozin data from the SOLOIST and SCORED Phase 3 clinical studies were presented at the ESC Congress 2021 highlighting the benefits seen in reduced heart failure hospitalizations, myocardial infarction and stroke.
LX9211
Patient enrollment continued in two ongoing Phase 2 clinical studies of LX9211 for the treatment of diabetic peripheral neuropathic pain and the treatment of post-herpetic neuralgia. Results from these clinical studies are currently expected in the first half of 2022.
Corporate
Craig B. Granowitz, M.D., Ph.D. joined Lexicon as senior vice president and chief medical officer, with a deep and successful history in cardiovascular medicine. Dr. Granowitz will lead the build-out of Lexicon’s medical affairs organization as the company prepares for the potential launch of sotagliflozin for the treatment of heart failure in patients with type 2 diabetes.
Third Quarter 2021 Financial Highlights
Revenues: Revenues for the three months ended September 30, 2021 were negligible as compared to $6.6 million for the corresponding period in 2020, primarily due to the absence of product revenues as a result of Lexicon’s sale of its XERMELO product and related assets to TerSera Therapeutics LLC during the third quarter of 2020.
Research and Development (R&D) Expenses: Research and development expenses for the three months ended September 30, 2021 decreased to $15.7 million from $40.1 million for the corresponding period in 2020, primarily due to decreases in external clinical development costs related to sotagliflozin resulting from the completion of clinical studies.
Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the three months ended September 30, 2021 decreased to $7.3 million from $12.0 million for the corresponding period in 2020, primarily due to lower salaries and benefits costs as a result of reductions in personnel in September 2020 and lower marketing expenses, all primarily associated with the sale of XERMELO and related assets during the third quarter of 2020.
Net Loss: Net loss for the three months ended September 30, 2021 was $23.1 million, or $0.16 per share, as compared to net income of $82.6 million, or $0.71 per diluted share, in the corresponding period in 2020. The three months ended September 30, 2020 included a gain of $132.8 million from the sale of XERMELO and related assets to TerSera. For the three months ended September 30, 2021 and 2020, net income included non-cash, stock-based compensation expense of $2.7 million and $1.9 million, respectively.
Cash and Investments: As of September 30, 2021, Lexicon had $120.9 million in cash and investments, as compared to $152.3 million as of December 31, 2020.
Conference Call and Webcast Information
Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 8564549. 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.
About the SOLOIST and SCORED Studies
SOLOIST was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.
SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73 m2 of body-surface area, and risks for cardiovascular disease. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.
Both SOLOIST and SCORED achieved their respective primary endpoints. Results from both studies were presented at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in two separate articles titled: "Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure" and "Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease."