Xeris Biopharma(XERS)
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Xeris Biopharma(XERS) - 2024 Q1 - Earnings Call Transcript
2024-05-09 16:49
Xeris Biopharma Holdings, Inc. (NASDAQ:XERS) Q1 2024 Earnings Conference Call May 9, 2024 8:30 AM ET Company Participants Allison Wey - SVP, IR & Corporate Communications Paul Edick - Chairman & CEO Steven Pieper - CFO Conference Call Participants Oren Livnat - H.C. Wainwright & Co. Roanna Ruiz - Leerink Partners Rohan Mathur - Oppenheimer Kelly Close - Analyst Operator Hello, everyone, and welcome to the Xeris Biopharma First Quarter 2024 Financial Results Conference Call and Webcast. My name is Seth, and ...
Xeris Biopharma(XERS) - 2024 Q1 - Quarterly Results
2024-05-09 11:14
[Q1 2024 Performance Highlights](index=1&type=section&id=First%20Quarter%202024%20Highlights) Xeris Biopharma reported a strong first quarter with total revenue of $40.6 million, a 22% increase year-over-year, tightening its full-year 2024 revenue guidance to $175-$200 million, and ending the quarter with a solid cash position of $87.4 million while securing significant new technology partnerships | Metric | Q1 2024 | Q1 2023 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | $40.6M | $33.2M | +$7.4M | +22.4% | - Full-year 2024 total revenue guidance has been tightened to a range of **$175 million to $200 million**[1](index=1&type=chunk)[4](index=4&type=chunk) - Ended Q1 2024 with **$87.4 million** in cash, cash equivalents, and short-term investments, with the borrowing rate on Hayfin debt lowered by **2.05%**[1](index=1&type=chunk)[10](index=10&type=chunk) - Entered into a worldwide license agreement with Amgen for a XeriJect® formulation of teprotumumab and an exclusive worldwide agreement with Beta Bionics for a new XeriSol™ formulation of glucagon[1](index=1&type=chunk)[17](index=17&type=chunk) [Commercial Product Performance](index=1&type=section&id=Commercial%20Products) Total product revenue grew 25% to $40.3 million, primarily driven by a remarkable 137% surge in Recorlev sales, while Gvoke revenue increased by 10% to $16.6 million despite an estimated $3 million negative impact from the Change Healthcare cyberattack, and Keveyis sales remained resilient, growing 3% to $13.1 million | Product | Q1 2024 Net Revenue (in thousands) | Q1 2023 Net Revenue (in thousands) | % Change | | :--- | :--- | :--- | :--- | | Gvoke® | $16,579 | $15,033 | 10.3% | | Keveyis® | $13,085 | $12,755 | 2.6% | | Recorlev® | $10,599 | $4,477 | 136.7% | | **Total Product Revenue** | **$40,263** | **$32,265** | **24.8%** | - Gvoke's market share of the retail TRx glucagon market grew to over **36%** through late April 2024[6](index=6&type=chunk) - Recorlev's average number of patients increased by **139%** compared to Q1 2023 and **18%** compared to Q4 2023[6](index=6&type=chunk) - Gvoke revenue was negatively impacted by an estimated **$3 million** due to the Change Healthcare cyberattack[4](index=4&type=chunk) [Pipeline and Technology Partnerships](index=2&type=section&id=Pipeline%20and%20Technology%20Partnerships) The company advanced its pipeline by successfully completing the Phase 2 clinical study for XeriSol™ levothyroxine (XP-8121), with data expected mid-2024, and expanded its technology partnerships by signing an exclusive worldwide license with Amgen for its XeriJect® technology and a collaboration with Beta Bionics for its XeriSol™ technology - Successfully completed the Phase 2 clinical study for XeriSol™ levothyroxine (XP-8121); data is expected to be available in mid-2024[7](index=7&type=chunk) - Entered an exclusive worldwide license agreement with Amgen for a XeriJect® formulation of teprotumumab, making Xeris eligible for up to **$75 million** in milestones plus escalating single-digit royalties[17](index=17&type=chunk) - Signed an exclusive worldwide collaboration and license agreement with Beta Bionics to develop a new XeriSol™ liquid stable glucagon formulation for use in bi-hormonal pumps[17](index=17&type=chunk) [Financial Results Analysis](index=2&type=section&id=Financial%20Results%20Analysis) For Q1 2024, Xeris reported a net loss of $19.0 million, or $0.14 per share, driven by higher operating expenses, including a $3.0 million rise in R&D for pipeline investments and a $4.8 million increase in SG&A from higher personnel and rent costs, while maintaining a strong cash position of $87.4 million - Research and development (R&D) expenses increased by **$3.0 million** YoY, driven by investments in the XP-8121 pipeline program and technology partnerships[9](index=9&type=chunk) - Selling, general and administrative (SG&A) expenses rose by **$4.8 million** YoY, mainly due to higher personnel costs and rent for the new headquarters[10](index=10&type=chunk) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net Loss | $19.0 million | $16.8 million | | Net Loss Per Share | $0.14 | $0.12 | - Cash, cash equivalents, and short-term investments totaled **$87.4 million** at March 31, 2024, an increase from **$72.5 million** at December 31, 2023[10](index=10&type=chunk) [Condensed Consolidated Financial Statements](index=4&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Xeris Biopharma Holdings, Inc. as of March 31, 2024, including the Statement of Operations for the first quarter and the Balance Sheet at the end of the period [Condensed Consolidated Statements of Operations](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) For the three months ended March 31, 2024, total revenues increased to $40.6 million from $33.2 million in the prior-year period, offset by a rise in total costs and expenses to $54.9 million from $46.5 million, resulting in a net loss of $19.0 million, compared to a net loss of $16.8 million in Q1 2023 | (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | **Total revenue** | **$40,638** | **$33,196** | | Total costs and expenses | $54,883 | $46,473 | | Loss from operations | ($14,245) | ($13,277) | | **Net loss** | **($18,980)** | **($16,834)** | | Net loss per common share | ($0.14) | ($0.12) | [Condensed Consolidated Balance Sheets](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of March 31, 2024, total assets were $336.6 million, an increase from $322.6 million at year-end 2023, with total liabilities also increasing to $345.8 million from $329.4 million, primarily due to a rise in long-term debt, resulting in a total stockholders' deficit of $9.2 million | (in thousands) | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Total current assets** | **$173,280** | **$156,264** | | **Total assets** | **$336,616** | **$322,602** | | Total current liabilities | $73,084 | $95,193 | | Long-term debt, net | $229,674 | $190,932 | | **Total liabilities** | **$345,794** | **$329,384** | | **Total stockholders' equity (deficit)** | **($9,178)** | **($6,782)** |
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
Financial Performance - For the six months ended June 30, 2023, Xeris reported a net loss of $36.7 million, compared to a net loss of $59.9 million for the same period in 2022, with an accumulated deficit of $591.4 million as of June 30, 2023[129]. - The net loss for Q2 2023 was $19.8 million, a decrease of 24.2% compared to a net loss of $26.2 million in Q2 2022[148]. - Net cash used in operating activities was $39.9 million for the six months ended June 30, 2023, a decrease from $69.0 million for the same period in 2022, primarily due to reduced working capital usage[165]. - Net cash used in investing activities was $35.5 million for the six months ended June 30, 2023, compared to net cash provided by investing activities of $18.6 million for the same period in 2022, mainly due to the purchase of short-term investments[166]. - Net cash used in financing activities was $0.3 million for the six months ended June 30, 2023, a significant decrease from net cash provided of $78.5 million for the same period in 2022[167]. - The company has incurred an accumulated deficit of $591.4 million as of June 30, 2023, and expects to continue incurring net losses for at least the next 12 months[162]. Revenue and Market Potential - The estimated total addressable market for Gvoke is approximately $5.0 billion, for Keveyis is greater than $0.5 billion, and for Recorlev is approximately $3.0 billion in the United States[126]. - Total revenue for Q2 2023 was $38.0 million, a 50.2% increase compared to $25.3 million in Q2 2022[148]. - Gvoke net revenue increased by $4.2 million or 36.2% for Q2 2023 compared to Q2 2022, with prescriptions growing approximately 49.7%[149]. - Keveyis net revenue increased by $1.3 million or 10.0% for Q2 2023 compared to Q2 2022, driven by higher patient demand and increased net pricing[150]. - Recorlev generated net revenue of $7.2 million for Q2 2023, primarily due to an increase in the number of patients on therapy[151]. Research and Development - Xeris is focused on the development of XP-8121, a once-weekly subcutaneous injection of levothyroxine, with a Phase 2 study initiated in June 2023[131][137]. - Research and development expenses have declined as funding has shifted towards commercial activities, although significant expenses are expected to continue[142]. - Research and development expenses rose by $2.4 million or 63.7% for Q2 2023 compared to Q2 2022, due to increased spending on clinical studies[154]. Operational Strategy - The company is committed to maximizing the potential of its three commercial products: Gvoke, Keveyis, and Recorlev, which address unique unmet needs[125]. - Xeris has established a proven capability to bring new products through the development and regulatory process to successful commercialization[132]. - The company plans to continue its marketing and selling efforts related to Gvoke, Keveyis, and Recorlev while pursuing research and development initiatives[131]. - Xeris aims to leverage its proprietary formulation science to enhance drug delivery and clinical profiles of other companies' products through collaborations[132]. Financial Position and Future Outlook - Xeris has received gross proceeds of $253.0 million from public equity offerings and $150.0 million from the Hayfin Loan Agreement in 2022[128]. - The company believes its cash resources are sufficient to sustain operations and capital expenditure requirements for at least the next 12 months[162]. - Future capital requirements will depend on various factors, including the success of commercializing Gvoke, Keveyis, and Recorlev, and the costs associated with clinical trials and regulatory reviews[165]. - The company may need to obtain additional financing in the future to support its marketing and selling efforts for Gvoke, Keveyis, and Recorlev[163]. Cost and Expense Management - Cost of goods sold increased by $2.7 million or 57.1% for Q2 2023 compared to Q2 2022, attributed to higher product sales and product mix[152]. - Selling, general and administrative expenses increased by $4.7 million or 14.1% for Q2 2023 compared to Q2 2022, driven by higher personnel and marketing costs[155]. - Interest expense increased by $3.1 million or 89.3% for Q2 2023 compared to Q2 2022, primarily due to a higher principal amount and increased interest rates[157]. Risk Factors - A hypothetical one-percentage point increase or decrease in interest rates would affect interest income by approximately $0.8 million annually[171]. - The company is exposed to interest rate risk primarily related to its floating rate borrowings under the Hayfin Loan Agreement[172]. - As of June 30, 2023, the company had immaterial liabilities denominated in the Australian Dollar, with no material effect on operations from foreign currency fluctuations[173].
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
Financial Performance - For the three months ended March 31, 2023, Xeris reported a net loss of $16.8 million, compared to a net loss of $33.7 million for the same period in 2022, with an accumulated deficit of $571.6 million as of March 31, 2023[128]. - Product revenue for the three months ended March 31, 2023, was $32.3 million, a 47.3% increase from $21.9 million in the same period of 2022[149]. - Gvoke net revenue increased by $2.6 million or 20.7%, with prescriptions growing approximately 50% year-over-year[150]. - Keveyis net revenue rose by $3.4 million or 36.8%, driven by higher patient demand and increased net pricing[151]. - Total expenses decreased by $4.7 million or 9.1%, from $51.1 million in Q1 2022 to $46.5 million in Q1 2023[149]. - Research and development expenses decreased by $1.4 million or 22.6%, primarily due to lower product development costs[154]. - Interest expense increased by $2.7 million or 76.5%, attributed to a higher principal amount and increased interest rates related to the Hayfin loan[157]. - Net cash used in operating activities was $26.1 million for Q1 2023, down from $48.4 million in Q1 2022, indicating reduced working capital usage[165]. - Net cash used in investing activities was $44.0 million in Q1 2023, compared to net cash provided of $6.7 million in Q1 2022, primarily due to short-term investments[166]. - As of March 31, 2023, the accumulated deficit was $571.6 million, with expectations of continued net losses for at least the next 12 months[162]. Market Potential - The estimated total addressable market for Gvoke is approximately $5.0 billion, for Keveyis is greater than $0.5 billion, and for Recorlev is approximately $3.0 billion in the United States[125]. Product Development - The company is focused on the development of XP-8121, a once-weekly subcutaneous injection of levothyroxine, with a Phase 2 dose-finding study commenced in April 2023[130]. - Xeris aims to leverage its proprietary formulation science to enhance drug delivery and clinical profiles of other companies' products through collaborations[132]. - The company is committed to maximizing the potential of its three commercial products: Gvoke, Keveyis, and Recorlev, which address unique unmet needs in the market[132]. - Xeris has established a proven capability to bring new products through the development and regulatory process to successful commercialization[132]. Financing and Capital Requirements - The company anticipates continued operating losses and may seek additional public equity and debt financing to meet capital requirements[128]. - The company may need additional financing in the future to support marketing and selling efforts for Gvoke, Keveyis, and Recorlev[163]. Interest and Currency Impact - Interest income from cash, cash equivalents, restricted cash, and investments could change by approximately $1.0 million annually with a hypothetical one-percentage point increase or decrease in interest rates as of March 31, 2023[171]. - The company incurs interest on outstanding borrowings at a floating rate of 9.0% per annum, which may decrease to 8.0% if the Wall Street Journal Prime Rate is applicable[172]. - As of March 31, 2023, the company had immaterial liabilities denominated in the Australian Dollar, with net foreign currency gains and losses not materially affecting operations for the three months ended March 31, 2023[173].
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 ...