Workflow
Xeris Biopharma(XERS)
icon
Search documents
Xeris Biopharma(XERS) - 2023 Q4 - Annual Report
2024-03-06 21:10
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, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 1375 West Fulton Street, Suite 1300 (Address of principal executive offices) (Zip Code) (844) ...
Xeris Biopharma(XERS) - 2023 Q4 - Earnings Call Transcript
2024-03-06 17:43
Xeris Biopharma Holdings Inc. (NASDAQ:XERS) Q4 2023 Earnings Conference Call March 6, 2024 8:30 AM ET Company Participants Paul Edick - Chairman, Chief Executive Officer Steve Pieper - Chief Financial Officer Allison Wey - Senior Vice President, Investor Relations Conference Call Participants Oren Livnat - HC Wainwright Glen Santangelo - Jefferies Chase Knickerbocker - Craig Hallum Roanna Ruiz - Leerink Partners David Amsellem - Piper Sandler Operator Hello everyone and welcome to the Xeris fourth quarter a ...
Xeris Biopharma(XERS) - 2023 Q3 - Quarterly Report
2023-11-09 21:10
Table of Contents 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, 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: 001-40880 XERIS BIOPHARMA HOLDINGS, INC. (Exact name of the registrant as specified in its ch ...
Xeris Biopharma(XERS) - 2023 Q3 - Earnings Call Transcript
2023-11-09 20:17
Financial Data and Key Metrics - Total net revenue for Q3 2023 was $48 million, a 63% increase compared to Q3 2022 and a 27% increase from Q2 2023 [5] - Full-year 2023 revenue guidance was tightened to $160 million to $165 million, expecting to hit the top end of the original guidance [6] - Cash position at the end of Q3 2023 was approximately $66 million, with expectations to achieve cash flow breakeven in Q4 2023 [21][35] Business Line Performance - Gvoke generated $17.7 million in net revenue in Q3 2023, a 30% increase compared to Q3 2022, with total prescriptions growing 52% year-over-year [7][24] - Recorlev generated $8.1 million in net revenue in Q3 2023, a 221% increase compared to Q3 2022 and a 13% increase from Q2 2023 [11][26] - Keveyis generated $15.9 million in net revenue in Q3 2023, a 19% increase compared to Q3 2022 and a 13% increase from Q2 2023 [13][27] Market Performance - Gvoke's market share in the retail glucagon market grew to approximately 33% for new prescriptions and 31% for total prescriptions by the end of October 2023 [8] - The glucagon prescription market grew 16% in Q3 2023, with Gvoke's total prescriptions growing 14% in the same period [25] - Recorlev's patient demand grew 12% over Q2 2023, with strong referrals indicating future growth potential [11][26] Strategic Direction and Industry Competition - The company is focused on building a patient-centric, self-sustaining biopharma enterprise, with strong execution across its three business pillars: commercial products, new product development, and technology partnerships [5][6] - Gvoke continues to outpace competitors in the glucagon market, with the company investing in sales team expansion to maintain momentum [8][9] - Recorlev is gaining traction as a first-line treatment for Cushing's syndrome, with healthcare professionals valuing its multipronged approach to cortisol suppression [12] Management Commentary on Operating Environment and Future Outlook - Management expects total net revenue to grow from 2023 levels in 2024, with operating expenses remaining flat and continued reduction in cash burn [19][38] - The company is optimistic about the large market opportunity for Gvoke, with less than 10% of at-risk patients currently having a ready-to-use glucagon product [9][10] - The XeriJect technology platform is seen as a key differentiator, with successful formulation of TEPEZZA and ongoing collaborations with Amgen and Regeneron [15][17] Other Important Information - The company successfully formulated the ultra-concentrated subcutaneous version of XeriJect TEPEZZA, triggering a $6 million success payment from Amgen [15][23] - The Phase 2 study for XeriSol levothyroxine is over 80% enrolled, with data expected mid-2024 to inform the Phase 3 program [14] - The company exchanged approximately two-thirds of its 2025 convertible senior notes for 2028 notes, reducing near-term debt obligations [22] Q&A Session Summary Questions on Recorlev - Management discussed Recorlev's patient footprint and competitive landscape, noting strong referral growth and low discontinuation rates [40][44][46] - The company views Corcept's relacorilant as a potential competitor but believes Recorlev's superior product performance will maintain its market position [42] Questions on Gvoke - Management highlighted Gvoke's strong growth in the glucagon market, with a 50% increase in prescriptions year-to-date [59] - The company sees Amphastar's Baqsimi as a positive addition to the market, helping to increase awareness and adoption of ready-to-use glucagon products [41] Questions on Financials and Strategy - The company is committed to achieving cash flow breakeven in Q4 2023 and does not anticipate shareholder dilution [50] - Operating expenses are growing at a slower rate than revenue, with SG&A expenses expected to decrease further in Q4 2023 [52][54] - Management is focused on maintaining a self-sustaining business model and investing in growth opportunities rather than pursuing share buybacks [56] Questions on XeriJect Technology - The XeriJect platform offers competitive advantages in delivering ultra-high concentrated subcutaneous injections, with potential to move IV-administered drugs to self-administration [69] - Partnerships with Amgen and Regeneron are progressing well, but timelines for further development and commercialization depend on partner decisions [67][68] Questions on Future Plans - The company is actively evaluating potential acquisitions and pipeline additions but remains disciplined in resource allocation [65][76] - Management is committed to building a growth-oriented biopharmaceutical company and improving patient lives across its range of therapies [79]
Xeris Biopharma(XERS) - 2023 Q2 - Quarterly Report
2023-08-08 20:11
Table of Contents 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: 001-40880 XERIS BIOPHARMA HOLDINGS, INC. (Exact name of the registrant as specified in its charter ...
Xeris Biopharma(XERS) - 2023 Q2 - Earnings Call Transcript
2023-08-08 15:55
Xeris Biopharma Holdings, Inc. (NASDAQ:XERS) Q2 2023 Results Conference Call August 8, 2023 8:30 AM ET Company Participants Allison Wey - Senior Vice President of Investor Relations Paul Edick - Chairman and Chief Executive Officer Steven Pieper - Chief Financial Officer Conference Call Participants Oren Livnat - H. C. Wainwright Glen Santangelo - Jefferies Operator Good morning all. I would like to welcome you all to Xeris Biopharma Second Quarter 2023 Financial Results Call. My name is [Prika], and I will be ...
Xeris Biopharma(XERS) - 2023 Q1 - Quarterly Report
2023-05-09 20:31
Table of Contents 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: 001-40880 XERIS BIOPHARMA HOLDINGS, INC. (Exact name of the registrant as specified in its charte ...
Xeris Biopharma(XERS) - 2023 Q1 - Earnings Call Transcript
2023-05-09 18:24
Xeris Biopharma Holdings, Inc. (NASDAQ:XERS) Q1 2023 Earnings Conference Call May 9, 2023 8:30 AM ET Company Participants Allison Wey - Senior Vice President, Investor Relations, and Corporate Communications Paul Edick - Chairman and Chief Executive Officer Steve Pieper - Chief Financial Officer Conference Call Participants Oren Livnat - H.C. Wainwright Glen Santangelo - Jefferies Roanna Ruiz - SVB Securities Operator Hello all and warm welcome to the Xeris Biopharma Holding First Quarter 2023 Financial Res ...
Xeris Biopharma(XERS) - 2022 Q4 - Annual Report
2023-03-08 21:11
UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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: 001-40880 XERIS BIOPHARMA HOLDINGS, INC. (Exact name of the registrant as specified in its charter) 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 Delaware 87-1082097 ...
Xeris Biopharma(XERS) - 2022 Q4 - Earnings Call Transcript
2023-03-08 15:56
Financial Data and Key Metrics Changes - The company reported a net product revenue growth of 52% for Q4 2022 and 38% for the full year on a pro forma basis, finishing the year with $110 million in total revenue [9][34] - Cash on hand exceeded $120 million at year-end 2022, indicating strong liquidity [9] - Total net product revenue for 2022 was over $109 million, achieving the top end of guidance [34] Business Line Data and Key Metrics Changes - Gvoke achieved net revenue of $15 million in Q4 2022, a 36% increase year-over-year, with total prescriptions growing over 42% [11][12] - Keveyis generated approximately $14 million in Q4 2022, representing a 33% increase, and over $49 million for the full year, a 23% increase [17][39] - Recorlev net revenue for Q4 was $3.8 million, a 51% increase from the previous quarter, with total revenue for 2022 at $7.4 million [19][41] Market Data and Key Metrics Changes - The total glucagon market grew 6% in Q4 2022 and 9% for the full year, with Gvoke outpacing market growth [13] - Gvoke's market share of new prescriptions reached approximately 28%, with ready-to-use glucagon products representing nearly 75% of the new prescription market [14] Company Strategy and Development Direction - The company aims to achieve cash flow breakeven in Q4 2023 without needing additional capital, positioning itself as a self-sustaining enterprise [10][52] - The focus is on advancing the levothyroxine program and developing partnerships, such as the collaboration with Horizon Therapeutics for TEPEZZA [21][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth and the potential for a pivotal year in 2023, driven by strong revenue growth and disciplined expense management [31][55] - The company anticipates total revenues between $135 million and $165 million for 2023, reflecting a growth rate of approximately 36% from 2022 [31][42] Other Important Information - The company has not yet experienced a negative impact from the first generic entry of Keveyis, although it remains a concern for the future [17][40] - The company is preparing for potential impacts from deductible resets on patient access to Recorlev, which is common in rare disease products [72] Q&A Session Summary Question: Guidance range and factors affecting it - Management acknowledged the wider guidance range due to multiple moving parts, including the early stage of Recorlev's launch and uncertainty regarding Keveyis' generic impact [56][57] Question: Current market status of Keveyis - Management confirmed that no generics are currently operational in the market, and patient support systems are in place to maintain business [59][60] Question: Titration process for Recorlev - Management indicated that titration is slower in real-world settings compared to clinical studies, with physicians managing doses carefully [64][66] Question: Contribution from other revenues - Management noted that the contribution from partnerships and collaborations is uncertain and depends on the speed of achieving target product profiles [69][70] Question: Payer coverage for Recorlev - Management reported that prior authorization hurdles exist but success rates are better than 50%, with many appeals resulting in approvals [74][76] Question: Gvoke's growth outlook - Management expects Gvoke to continue its growth trajectory, with minimal impact from generics and a rebound in market growth [80][81] Question: Competitive dynamics for Recorlev - Management believes Recorlev is performing well against competitors, with a focus on demonstrating its efficacy compared to existing treatments [82][84] Question: Timeline for levothyroxine injectable product - Management indicated that the earliest filing for the levothyroxine injectable product could be between 2026 and 2028, depending on the Phase 2 study outcomes [87]