On May 3, 2016 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months ended March 31, 2016 and provided an overview of key milestones for the company’s lead drug candidates (Filing, Q1, Lexicon Pharmaceuticals, 2016, MAY 3, 2016, View Source [SID:1234511829]).
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"We closed out the quarter with the filing of the NDA for telotristat etiprate, an important milestone for the company," said Lexicon President and Chief Executive Officer, Lonnel Coats. "We look forward to working closely with the FDA during the review process of this investigational treatment for the care of patients living with carcinoid syndrome."
Pipeline Progress
Telotristat etiprate is the first investigational drug in clinical studies to target tryptophan hydroxylase (TPH), the rate-limiting enzyme involved in serotonin production. Excess production of serotonin within metastatic neuroendocrine tumor cells can lead to carcinoid syndrome, a condition characterized by serious consequences including frequent and debilitating diarrhea, facial flushing, abdominal pain, and heart valve damage.
On March 30, 2016, Lexicon announced that it had submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of telotristat etiprate, an oral drug for the treatment of carcinoid syndrome. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Lexicon has requested a Priority Review by the FDA as part of the NDA filing.
Sotagliflozin, which is being developed as a potential treatment for type 1 and type 2 diabetes, is a dual inhibitor of sodium-glucose transporters 1 and 2 (SGLT1 and SGLT2), each of which modulates glucose levels, and is the first investigational medicine to target both of these two proteins.
Lexicon recently entered into a collaboration with Sanofi, in which Lexicon will continue to be responsible for clinical development activities relating to type 1 diabetes and Sanofi will be responsible for clinical development activities relating to type 2 diabetes. Lexicon is conducting three Phase 3 clinical trials of sotagliflozin in patients with type 1 diabetes, one of which has already completed enrollment and the second of which has completed patient screening, and expects top-line results from its two pivotal Phase 3 clinical trials to be available in the second half of 2016. Lexicon expects that Phase 3 development of sotagliflozin in patients with type 2 diabetes will be initiated by Sanofi by the end of 2016.
Financial Highlights
Revenues: Lexicon’s revenues for the three months ended March 31, 2016 increased to $12.5 million from $1.8 million for the corresponding period in 2015, primarily due to revenues recognized from the collaboration and license agreement with Sanofi.
Research and Development Expenses: Research and development expenses for the three months ended March 31, 2016 increased 77 percent to $37.0 million from $20.9 million for the corresponding period in 2015, primarily due to increases in external clinical and nonclinical research and development costs.
Change in Fair Value of Symphony Icon Purchase Liability: In connection with the acquisition of Symphony Icon, Lexicon made an initial estimate of the fair value of the liability for the associated base and contingent payments. Changes in this liability, based on the development of the programs and the time until such payments are expected to be made, are recorded in Lexicon’s consolidated statements of operations. For the three months ended March 31, 2016 and 2015, the fair value of the Symphony Icon purchase liability increased by $1.0 million and $1.8 million, respectively.
General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2016 increased 47 percent to $8.4 million from $5.7 million for the corresponding period in 2015, primarily due to increased costs in preparation for commercialization of telotristat etiprate.
Consolidated Net Loss: Net loss for the three months ended March 31, 2016 was $34.9 million, or $0.34 per share, compared to a net loss of $28.1 million, or $0.27 per share, in the corresponding period in 2015. For the three months ended March 31, 2016 and 2015, net loss included non-cash, stock-based compensation expense of $1.8 million and $2.0 million, respectively.
Cash and Investments: As of March 31, 2016, Lexicon had $477.1 million in cash and investments, as compared to $521.4 million as of December 31, 2015.
Reverse Stock Split: In May 2015, Lexicon completed a one-for-seven reverse stock split. All references to common shares and per-share data for all periods presented in this release have been adjusted to give effect to this reverse stock split.