Lexicon Pharmaceuticals(LXRX)
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Lexicon Pharmaceuticals(LXRX) - 2023 Q3 - Earnings Call Transcript
2023-11-08 16:01
Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) Q3 2023 Earnings Conference Call November 8, 2023 8:00 AM ET Company Participants Carrie Siragusa - VP of Marketing Lonnel Coats - CEO Tom Garner - Chief Commercial Officer Craig Granowitz - Chief Medical Officer Jeffrey Wade - President and CFO Conference Call Participants Andrew Tsai - Jefferies Joseph Stringer - Needham & Company Operator Good day and welcome to the Lexicon Pharmaceuticals' Third Quarter 2023 Financial Results Conference Call. Today all partici ...
Lexicon Pharmaceuticals(LXRX) - 2023 Q2 - Quarterly Report
2023-08-04 11:07
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from _____________ to _____________ Commission File Number: 000-30111 Lexicon Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in its Charter) (State or ...
Lexicon Pharmaceuticals(LXRX) - 2023 Q2 - Earnings Call Transcript
2023-08-04 02:01
Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) Q2 2023 Earnings Conference Call August 3, 2023 5:00 PM ET Company Participants Carrie Siragusa - Vice President of Marketing Lonnel Coats - Chief Executive Officer Jeffrey Wade - President and Chief Financial Officer Craig Granowitz - Chief Medical Officer Conference Call Participants Carly Kenselaar - Citigroup Inc. Andrew Tsai - Jefferies Group LLC Operator Good day, and welcome to the Lexicon Pharmaceuticals Second Quarter 2023 Financial Results Conference Cal ...
Lexicon Pharmaceuticals(LXRX) - 2023 Q1 - Quarterly Report
2023-05-04 11:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from _____________ to _____________ Commission File Number: 000-30111 Lexicon Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in its Charter) (State o ...
Lexicon Pharmaceuticals(LXRX) - 2023 Q1 - Earnings Call Transcript
2023-05-03 00:27
Financial Data and Key Metrics - The company ended Q1 2023 with $105.9 million in cash and investments, providing sufficient resources for commercial preparations and R&D investments [42] - Selling, general, and administrative expenses increased to $19.5 million in Q1 2023, up from $8.5 million in Q1 2022, primarily due to headcount growth and commercial launch preparations for sotagliflozin [43] - Net loss for Q1 2023 was $23.5 million, or $0.16 per share, compared to the same period in 2022 [51] Business Line Data and Key Metrics - Sotagliflozin, a dual SGLT1 and 2 inhibitor for heart failure, is on track for its PDUFA target date of May 27th, with no substantial review issues identified by the FDA [5] - LX9211, an AAK1 inhibitor for neuropathic pain, has shown consistent results across two Phase 2 studies, with FDA feedback expected in Q2 2023 for late-stage development plans [4][49] - The neuropathic pain market is projected to grow by over 13% worldwide between 2020 and 2026, reaching $13.2 billion, presenting a significant opportunity for LX9211 [45] Market Data and Key Metrics - Heart failure is a multi-billion dollar market with substantial growth potential, driven by increasing disease prevalence and new treatment guidelines recommending SGLT inhibitors [12] - The annual cost of heart failure is expected to rise to nearly $70 billion by 2030, with 80% of costs due to hospitalizations, highlighting the need for better treatment options [8] - Currently, fewer than 10% of heart failure patients are discharged with a prescription for an SGLT inhibitor, indicating a significant market opportunity for sotagliflozin [21] Company Strategy and Industry Competition - The company is focusing on the transition of care patient population for sotagliflozin, leveraging its unique data on reducing hospital readmissions and cardiovascular mortality [55][65] - Updated heart failure treatment guidelines and the early adoption curve for SGLT inhibitors provide a strong tailwind for sotagliflozin's commercial launch [36][98] - LX9211 is being advanced as a potential new mechanism for treating neuropathic pain, with plans to optimize dosing regimens and pursue late-stage development [49][72] Management Commentary on Operating Environment and Future Outlook - Management is confident in the commercial launch preparations for sotagliflozin, with infrastructure and resources in place for a successful launch in Q2 2023 [32][75] - The company is actively engaging with payers, hospital systems, and government institutions to ensure broad access and formulary coverage for sotagliflozin [6][65] - Feedback from the FDA on LX9211's development path is expected in Q2 2023, with plans to advance the program into late-stage development [49][62] Other Important Information - The company has secured a loan facility with Oxford Finance, providing up to $100 million in additional borrowing capacity, including $75 million available upon sotagliflozin approval [73] - Sotagliflozin has demonstrated a 33% reduction in the composite endpoint of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits, with a need to treat only four patients for one year to avoid one event [13] - LX9211 has shown consistent efficacy across two Phase 2 studies, with no drug-related serious adverse events or deaths reported [47][71] Q&A Session Summary Question: What should investors focus on regarding the potential label for sotagliflozin? - The company expects a broad label for sotagliflozin, covering heart failure across all left ventricular ejection fractions, including HFpEF [53][77] Question: What are the key drivers for sales acceleration in 2023 and 2024? - The company will focus on penetrating integrated delivery networks (IDNs) and securing Medicare coverage in 2023, with net sales growth expected in 2024 [79] Question: What is the status of LX9211's development and potential partnerships? - The company is advancing LX9211 into late-stage development for diabetic peripheral neuropathic pain (DPN) and is open to partnerships but will not delay development [62][95] Question: How receptive are payers and hospital systems to sotagliflozin's value proposition? - Receptivity has been very encouraging, with the unique data from the SOLOIST trial resonating well with payers and hospital systems [65][87] Question: Can sotagliflozin be commercially successful with a narrow label? - Management is confident in a broad label scenario but believes sotagliflozin can still differentiate and capture market share even with a narrower label [90][101]
Lexicon Pharmaceuticals(LXRX) - 2022 Q4 - Earnings Call Transcript
2023-03-03 18:32
Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) Q4 2022 Earnings Conference Call March 2, 2023 5:00 PM ET Company Participants Carrie Siragusa – Executive Director, Corporate Strategy and Investor Relations Lonnel Coats – Chief Executive Officer Jeff Wade – President and Chief Financial Officer Craig Granowitz – Senior Vice President and Chief Medical Officer Conference Call Participants Yasmeen Rahimi – Piper Sandler Carly Kenselaar – Citi Joseph Stringer – Needham & Company Operator Good afternoon, and welcom ...
Lexicon Pharmaceuticals(LXRX) - 2022 Q4 - Annual Report
2023-03-03 12:25
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from _____________ to _____________ Commission File Number: 000-30111 Lexicon Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 76-0 ...
Lexicon Pharmaceuticals(LXRX) - 2022 Q3 - Earnings Call Transcript
2022-11-10 02:34
Financial Data and Key Metrics Changes - The company ended Q3 2022 with $136.2 million in cash and investments, including net proceeds of $94.3 million from a public offering and private placement [29] - Research and development expenses decreased to $10.6 million from $15.7 million in Q3 2021, primarily due to lower external clinical research expenses [32] - Selling, general and administrative expenses increased to $12.6 million from $7.3 million in Q3 2021, mainly due to increased personnel and external expenses related to the commercial launch preparations [33] - The net loss for Q3 2022 was $23.4 million, or $0.13 per share, compared to a net loss of $23.1 million, or $0.16 per share, in Q3 2021 [33] Business Line Data and Key Metrics Changes - The company is actively developing two lead programs: sotagliflozin for heart failure and LX9211 for neuropathic pain [8] - Sotagliflozin is positioned to enter the heart failure market, with a PDUFA target action date anticipated in May 2023 [9] - LX9211 has shown positive top-line results in a Phase II proof-of-concept study for painful diabetic neuropathy, with final data to be presented at an upcoming summit [10][27] Market Data and Key Metrics Changes - Over 6 million people in the U.S. are living with heart failure, with about 1 million new cases diagnosed each year, indicating a large and growing market [11] - Heart failure is the leading cause of hospitalization for Americans over 65, with approximately 1 million hospitalizations annually [12] Company Strategy and Development Direction - The company aims to differentiate sotagliflozin in the heart failure market through unique data from the SOLOIST-WHF trial, which demonstrated significant effects on reducing cardiovascular mortality and hospital readmissions [9][18] - The company is exploring potential partnerships for LX9211 to advance its development and is engaged in discussions to find a strategic fit [26][61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming regulatory review for sotagliflozin, noting no significant issues were raised during the mid-cycle review meeting with the FDA [8][37] - The company anticipates launching sotagliflozin in the U.S. in the first half of 2023, contingent on regulatory approval [66] Other Important Information - The company has been granted fast track designation by the FDA for LX9211 in diabetic peripheral neuropathic pain [20] - The final results of the RELIEF-DPN trial will be presented at the 16th Annual Pain Therapeutic Summit, providing further insights into the efficacy of LX9211 [27] Q&A Session Summary Question: Did the FDA request additional data during the mid-cycle review? - Management confirmed that the FDA did not request any new data, indicating a comprehensive submission package [37] Question: Can you elaborate on the potential unique label for sotagliflozin? - Management indicated confidence in obtaining label elements for recent worsening heart failure, as this was the population studied in the SOLOIST trial [39] Question: What differentiates sotagliflozin from other SGLT2 inhibitors? - Management highlighted that other SGLT2 data did not show significant separation until 90 days, while sotagliflozin demonstrated a 52% reduction in all-cause death or heart failure-related events at 90 days [50] Question: What are the plans for LX9211 beyond diabetic neuropathy? - Management noted that preclinical data supports exploring other types of neuropathic pain and potential applications in spasticity [61]
Lexicon Pharmaceuticals(LXRX) - 2022 Q3 - Quarterly Report
2022-11-09 21:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from _____________ to _____________ Commission File Number: 000-30111 Lexicon Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in its Charter) (Sta ...
Lexicon Pharmaceuticals(LXRX) - 2022 Q2 - Quarterly Report
2022-08-03 20:07
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Exact Name of Registrant as Specified in its Charter) (State or Other Jurisdiction of Incorporation or Organization) (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from _____________ to _____________ Commission ...