On April 27, 2020 Lexicon Pharmaceuticals, Inc (Nasdaq: LXRX), reported financial results and provided a business update for the three months ended March 31, 2020 (Press release, Lexicon Pharmaceuticals, APR 27, 2020, View Source [SID1234556618]).

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"We achieved 17% growth in XERMELO net sales for the first quarter of 2020 compared to the prior-year period, and we see favorable growth dynamics going forward," said Lonnel Coats, Lexicon’s president and chief executive officer. "We have made good progress on our pipeline, having fully enrolled the first efficacy cohort of 20 patients in the Phase 2 telotristat ethyl study in biliary tract cancer from which we expect top-line data later this year. Importantly, we are steps closer to advancing our next major innovation, LX9211, into a proof-of-concept study in diabetic peripheral neuropathic pain, which we expect to initiate mid-year. Finally, we are making progress on the close-out of the two sotagliflozin outcome studies, SCORED and SOLOIST, which we expect to conclude in the near term."

First Quarter Product and Pipeline Highlights

XERMELO (telotristat ethyl)

•XERMELO U.S. net sales were $7.9 million in the first quarter of 2020.
•Medical record data on XERMELO’s antiproliferative effects were presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Symposium in gastrointestinal cancers, showing that, among 200 patients with metastatic neuroendocrine tumors on standard background therapies, the mean tumor size was 0.59 cm smaller (p=0.006) in scans obtained after initiation of XERMELO.
•Medical record data on XERMELO’s antiproliferative effects in patients with carcinoid syndrome presented at the European Neuroendocrine Tumor Society (ENETS) meeting demonstrated that most patients with metastatic neuroendocrine tumors on standard background therapies had no tumor progression at 6, 12 and 18 months following initiation of XERMELO, with a median time to tumor progression (TTP) of 39.8 months. The majority of patients also experienced progression-free survival (PFS) in the period following initiation of XERMELO, with a median PFS of 23.7 months. In addition, in a subset of 22 patients with recorded biomarker data, mean serotonin levels decreased significantly in the period following initiation of XERMELO. Patients also improved on carcinoid syndrome (CS) symptoms, body weight and performance status.
•The Telotristat Ethyl for Advanced Biliary Tract Cancer, or TELE-ABC, study, a Phase 2a clinical study of telotristat ethyl in patients with biliary tract cancer, completed enrollment of 20 patients in the first efficacy cohort.

Sotagliflozin

•In March, Lexicon announced the early close-out of the two long-term outcomes studies of sotagliflozin, SCORED and SOLOIST, that were originally designed to demonstrate benefits in and support labeling for heart failure and chronic kidney disease.

First Quarter 2020 Financial Highlights

Revenues: Revenues for the three months ended March 31, 2020 decreased to $8.0 million from $9.2 million for the corresponding period in 2019, primarily due to a decrease of collaborative revenues, partially offset by an increase in net product revenue. Net product revenues for the three months ended March 31, 2020 consisted of $7.9 million from net sales of XERMELO in the U.S., up 17% from the prior year quarter.

Cost of Sales: Cost of sales related to sales of XERMELO for each of the three months ended March 31, 2020 and 2019 was $0.6 million.

Research and Development (R&D) Expenses: Research and development expenses for the three months ended March 31, 2020 increased to $55.2 million from $12.0 million for the corresponding period in 2019, primarily due to increases in external clinical development costs related to sotagliflozin subsequent to the termination of the alliance with Sanofi.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the three months ended March 31, 2020 were $14.7 million as compared to $14.1 million for the corresponding period in 2019.

Net Loss: Net loss for the three months ended March 31, 2020 was $66.6 million, or $0.63 per share, as compared to a net loss of $21.8 million, or $0.21 per share, in the corresponding period in 2019. For the three months ended March 31, 2020 and 2019, net income included non-cash, stock-based compensation expense of $4.4 million and $3.4 million, respectively.

Cash and Investments: As of March 31, 2020, Lexicon had $249.1 million in cash and investments, as compared to $271.7 million as of December 31, 2019.

Anticipated Near-Term Milestones

•Mid-2020 – Initiation of the Phase 2 study for LX9211 in diabetic peripheral neuropathic pain
•Q4 2020 – Data from the first efficacy cohort of the Phase 2 study of telotristat ethyl in biliary tract cancer
•2020 – Manuscript publications for XERMELO in carcinoid syndrome diarrhea

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 8:00 am EST / 7:00 am CST 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 9403118. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days.

About XERMELO (telotristat ethyl)

Discovered using Lexicon’s unique approach to gene science, XERMELO (telotristat ethyl) is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. We are commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

XERMELO (telotristat ethyl) Important Safety Information

•Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.

•Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
•Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

For more information about XERMELO, see Full Prescribing Information at www.xermelo.com

About Sotagliflozin

Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy.