Financial Performance - Xeris Biopharma Holdings, Inc. reported total revenue of $203.07 million for the year ended December 31, 2024, an increase of 24% compared to $163.91 million in 2023 [521]. - Product revenue, net for 2024 was $196.64 million, up 28% from $153.36 million in 2023 [521]. - The company incurred a net loss of $54.84 million in 2024, compared to a net loss of $62.26 million in 2023, reflecting a 12% improvement [521]. - Total costs and expenses increased to $236.72 million in 2024, up from $207.92 million in 2023, primarily driven by higher selling, general, and administrative expenses [521]. - The company reported a net loss of $54.8 million for the year ended December 31, 2024, compared to a net loss of $62.3 million in 2023 and $94.7 million in 2022, indicating a 12% improvement year-over-year [527]. Cash Flow and Liquidity - Net cash used in operating activities decreased to $37.0 million for the year ended December 31, 2024, from $47.0 million in 2023, primarily due to reduced working capital usage [462]. - Cash and cash equivalents as of December 31, 2024, were $71.62 million, an increase from $67.45 million in 2023 [518]. - The company had cash, cash equivalents, and restricted cash of $75.7 million at the end of 2024, up from $71.7 million in 2023 [529]. - The company expects to continue incurring net losses for at least the next 12 months, but believes current cash resources are sufficient to sustain operations during this period [535]. Debt and Financing - Long-term debt, net of current portion, rose to $217.01 million in 2024, compared to $190.93 million in 2023 [518]. - Total debt increased to $232,108,000 as of December 31, 2024, compared to $190,932,000 in 2023, reflecting a growth of 21.5% [608]. - The Amended and Restated Credit Agreement provided for $200 million in term loans, with an effective interest rate of approximately 11.4% [625]. - The company may finance operations through equity or debt financing, but there is no assurance that such funding will be available on acceptable terms, which could negatively impact financial condition and business strategies [536]. Revenue Recognition and Accounting Policies - The company recognizes revenue when customers obtain control of promised goods, with revenues recorded at the net product sales price after accounting for various allowances [471]. - The company applies significant judgments and estimates in determining allowances for patient copay assistance, commercial rebates, and government rebates, impacting reported revenues [471]. - If the company were to increase or decrease the returns reserve rate by 1%, it would have a $1.8 million impact on revenue for the year ended December 31, 2024 [552]. - The company offers savings programs to commercially insured patients, which are recorded as a reduction of product revenue [546]. Assets and Inventory - The company's total assets slightly increased to $323.06 million in 2024 from $322.60 million in 2023 [518]. - Total inventory as of December 31, 2024, was $48.18 million, compared to $38.84 million in 2023, reflecting a 24% increase [603]. - Inventory reserves increased to $7.7 million at December 31, 2024, from $2.4 million in 2023 [603]. Stock-Based Compensation - Stock-based compensation expenses increased to $18.4 million in 2024 from $10.7 million in 2023, reflecting higher employee incentives [527]. - The total fair value of RSUs vested during 2024 was $10.7 million, compared to $2.8 million in 2023 [656]. - The company recognized total stock-based compensation expense of $18.4 million in 2024, significantly higher than $10.7 million in 2023 [657]. Market Risks - The company is subject to market risks, including interest rate and foreign currency exchange rate fluctuations, but net foreign currency gains and losses did not materially affect operations for the year ended December 31, 2024 [480]. - A hypothetical one-percentage point increase or decrease in interest rates would impact interest income by approximately $0.8 million annually based on cash and investments outstanding as of December 31, 2024 [481]. Internal Controls and Compliance - The company maintained effective internal control over financial reporting as of December 31, 2024, according to the auditor's opinion [505]. - The company adopted several new accounting standards, including ASU 2023-03, with no material impact on financial statements [586].

Xeris Biopharma Holdings (XERS) Q4 2024 Earnings Call March 06, 2025 04:35 PM ET Company Participants Allison Wey - Senior Vice President of Investor Relations & Corporate CommunicationsJohn Shannon - CEOSteve Pieper - Chief Financial OfficerGlen Santangelo - Managing DirectorMazahir Alimohamed - Biotech Equity Research Associate Conference Call Participants Chase Knickerbocker - Senior Equity Research Analyst - HealthcareOren Livnat - MD - Senior Healthcare AnalystDavid Amsellem - Sr. Research AnalystLelan ...

Xeris Biopharma Holdings, Inc. (NASDAQ:XERS) Q4 2024 Earnings Conference Call March 6, 2025 8:30 AM ET Company Participants Allison Wey - SVP of IR, Corporate Communications John Shannon - CEO Steve Pieper - CFO Conference Call Participants Chase Knickerbocker - Craig-Hallum Oren Livnat - H.C. Wainwright Glen Santangelo - Jefferies David Amsellem - Piper Sandler Leland Gershell - Oppenheimer Mazahir Alimohamed - Leerink Partners Operator Good morning, and welcome to the Xeris Biopharma Fourth Quarter and Fu ...

Group 1 - Xeris Biopharma reported $60.1 million in revenue for Q4 2024, a year-over-year increase of 35.4% [1] - The EPS for the same period was -$0.03, improving from -$0.10 a year ago, with a surprise of +57.14% compared to the consensus estimate of -$0.07 [1][3] - The revenue reported was a slight miss of -0.81% against the Zacks Consensus Estimate of $60.59 million [1] Group 2 - Key product revenues included Gvoke at $23.26 million, Keveyis at $11.12 million, and Recorlev at $22.61 million, with Recorlev significantly outperforming its estimate of $11.19 million [4] - Royalty, contract, and other revenues were reported at $3.10 million, exceeding the average estimate of $1.30 million [4] - Overall product revenue, net, was $57 million, slightly above the estimated $56.26 million [4] Group 3 - Xeris Biopharma's shares returned +2.7% over the past month, contrasting with the Zacks S&P 500 composite's -3.5% change [3] - The company currently holds a Zacks Rank 2 (Buy), suggesting potential outperformance in the near term [3]

Group 1 - Xeris Biopharma reported a quarterly loss of $0.03 per share, better than the Zacks Consensus Estimate of a loss of $0.07, and an improvement from a loss of $0.10 per share a year ago, representing an earnings surprise of 57.14% [1] - The company posted revenues of $60.1 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 0.81%, but showing an increase from year-ago revenues of $44.39 million [2] - Xeris Biopharma shares have increased by approximately 11.2% since the beginning of the year, contrasting with a decline of -0.7% in the S&P 500 [3] Group 2 - The earnings outlook for Xeris Biopharma is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The trend for estimate revisions for Xeris Biopharma is currently favorable, leading to a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] - The current consensus EPS estimate for the upcoming quarter is -$0.08 on revenues of $54.1 million, and -$0.22 on revenues of $240.93 million for the current fiscal year [7] Group 3 - The Medical - Drugs industry, to which Xeris Biopharma belongs, is currently ranked in the bottom 46% of over 250 Zacks industries, which may impact stock performance [8] - VAXART, INC., another company in the same industry, is expected to report a quarterly loss of $0.10 per share, reflecting a year-over-year change of +16.7%, with revenues projected at $31.17 million, up 859.1% from the year-ago quarter [9]

Financial Results Announcement - Xeris Biopharma Holdings, Inc. announced preliminary financial results for Q4 and full year ended December 31, 2024 [7] - The press release detailing the financial results is attached as Exhibit 99.1 to the Form 8-K [7] Company Information - The company's common stock is traded on the Nasdaq Global Select Market under the symbol XERS [2] - The company is incorporated in Delaware and has its principal executive offices in Chicago, Illinois [4] Report Filing Details - The report was filed on January 10, 2025, and signed by Steven M. Pieper, the Chief Financial Officer [3]

Core Viewpoint - Wall Street anticipates a year-over-year increase in earnings for Xeris Biopharma, driven by higher revenues, with a focus on how actual results compare to estimates impacting stock price [1][2]. Financial Expectations - Xeris Biopharma is expected to report a quarterly loss of $0.07 per share, reflecting a year-over-year change of +30% [3]. - Revenues are projected to be $60.59 million, representing a 36.5% increase from the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has remained unchanged over the last 30 days, indicating stability in analyst expectations [4]. - The Most Accurate Estimate for Xeris Biopharma is higher than the Zacks Consensus Estimate, resulting in an Earnings ESP of +2.78%, suggesting a bullish outlook from analysts [10]. Earnings Surprise Prediction - A positive Earnings ESP reading is a strong indicator of an earnings beat, especially when combined with a Zacks Rank of 2 (Buy) [8][11]. - Xeris Biopharma's current Zacks Rank of 2 enhances the likelihood of beating the consensus EPS estimate [11]. Historical Performance - In the last reported quarter, Xeris Biopharma was expected to post a loss of $0.09 per share but actually reported a loss of $0.06, achieving a surprise of +33.33% [12]. - Over the past four quarters, the company has surpassed consensus EPS estimates two times [13]. Industry Context - Esperion Therapeutics, another player in the Zacks Medical - Drugs industry, is expected to report a loss of $0.14 per share, with a year-over-year change of +72% and projected revenues of $70.01 million, up 117.1% from the previous year [17]. - Esperion's consensus EPS estimate has remained unchanged, but a lower Most Accurate Estimate has resulted in an Earnings ESP of -8.70%, combined with a Zacks Rank of 4 (Sell), making it difficult to predict an earnings beat [18].

Core Viewpoint - The American Diabetes Association (ADA) and Xeris Pharmaceuticals have formed a multi-year strategic partnership to promote the importance of glucagon prescriptions for individuals with diabetes on blood glucose-lowering medications, particularly those at risk of severe hypoglycemia [1][2][3] Group 1: Partnership Objectives - The partnership aims to increase awareness and education regarding the necessity of having glucagon, preferably in a ready-to-use formulation, for individuals with diabetes treated with insulin or insulin secretagogues [1][2] - The ADA and Xeris will develop educational materials and training resources for healthcare professionals and individuals living with diabetes, alongside a national awareness campaign [2] Group 2: Health Statistics and Risks - It is estimated that up to 46% of individuals with type 1 diabetes and 21% of those with type 2 diabetes using insulin experience at least one severe hypoglycemia event annually [1] - Severe hypoglycemia is responsible for over 202,000 emergency department visits each year, with approximately 25% of these cases resulting in hospital admissions [1] Group 3: Company Profiles - The ADA is a leading health organization focused on ending diabetes and supporting individuals living with the condition, with 136 million Americans affected by diabetes or prediabetes [4] - Xeris Pharmaceuticals is a biopharmaceutical company that develops innovative products, including Gvoke®, a ready-to-use liquid glucagon for treating severe hypoglycemia [5]

Financial Performance - For the nine months ended September 30, 2024, the company reported a net loss of $49.7 million, compared to a net loss of $48.9 million for the same period in 2023, with an accumulated deficit of $666.7 million as of September 30, 2024[83]. - Product revenue increased by 26.8% to $52.9 million for the three months ended September 30, 2024, compared to $41.7 million for the same period in 2023[96]. - The net loss for the three months ended September 30, 2024, was $15.7 million, compared to a net loss of $12.2 million for the same period in 2023, reflecting a 29.1% increase[96]. - Total revenue for the nine months ended September 30, 2024, increased by 19.6% to $143.0 million compared to $119.5 million for the same period in 2023[96]. - The company has an accumulated deficit of $666.7 million as of September 30, 2024[107]. - Net cash used in operating activities was $39.0 million for the nine months ended September 30, 2024, a decrease from $54.5 million for the same period in 2023[112]. - Net cash used in investing activities was $5.1 million for the nine months ended September 30, 2024, compared to $20.9 million for the same period in 2023[113]. - Net cash provided by financing activities was $35.8 million for the nine months ended September 30, 2024, compared to a cash outflow of $0.4 million for the same period in 2023[114]. Product Development - Gvoke, Recorlev, and Keveyis are the three commercial products with total addressable markets of approximately $5.0 billion, $3.0 billion, and greater than $0.5 billion in the United States, respectively[77]. - The company is focused on developing XP-8121, a once-weekly subcutaneous injection of levothyroxine, which has shown positive Phase 1 data indicating a four-time target dose conversion factor when switching from oral levothyroxine[81]. - The Phase 1 study of XP-8121 involved 30 healthy participants, comparing its pharmacokinetics to oral levothyroxine, with results indicating slower absorption and higher extended exposure[80]. - The proprietary formulation technologies, XeriSol and XeriJect, enable the development of room-temperature stable, highly concentrated injectable formulations, enhancing drug delivery and patient experience[78]. - The company is pursuing formulation and development partnerships to enhance the clinical profile of other companies' proprietary drugs using its formulation science[75]. Expenses and Costs - Research and development expenses are expected to remain significant as the company advances its pipeline candidates and conducts clinical trials[91]. - Research and development expenses rose by $0.9 million or 17.0% for the three months ended September 30, 2024, driven by higher spending on the pipeline[101]. - Selling, general and administrative expenses increased by $7.7 million or 20.6% for the three months ended September 30, 2024, mainly due to CEO succession and restructuring costs[103]. - Cost of goods sold increased by 65.7% to $13.6 million for the three months ended September 30, 2024, primarily due to manufacturing process changes[100]. - Interest expense increased by $0.9 million or 13.7% for the three months ended September 30, 2024, due to a higher principal amount and increased interest rates[105]. Future Outlook and Financing - The company anticipates continued significant expenses and operating losses in the near term due to ongoing commercialization and research efforts[83]. - The company expects to incur substantial additional expenditures to support the marketing and selling of Gvoke, Recorlev, and Keveyis, as well as ongoing research and development activities[107]. - The Amended and Restated Credit Agreement provided for the New Lenders to extend $200.0 million in term loans to the company on the closing date[106]. - The company may need to obtain additional financing in the future, which may include public or private debt and/or equity financings[110]. - A hypothetical one-percentage point increase or decrease in interest rates would increase or decrease interest income by approximately $0.7 million on an annual basis[119]. - Interest on the 2025 Convertible Notes is assessed at a fixed rate of 5.0% annually, while interest on the 2028 Convertible Notes is assessed at a fixed rate of 8.0% annually[119]. - The company has granted a first priority security interest on substantially all of its assets, including intellectual property, under the Amended and Restated Credit Agreement[106].

Financial Data and Key Metrics Changes - Total revenue for Q3 2024 was over $54 million, with product revenue nearly $53 million, marking a 27% growth year-over-year [6][29] - Product revenue growth of 27% represents the 12th consecutive quarter of over 20% growth, with the last two quarters accelerating to 26% and 27% respectively [6][29] - Year-to-date net product revenue was $139.6 million, increasing by approximately 26% compared to the prior year [30] Business Line Data and Key Metrics Changes - Recorlev achieved net revenue of $17.7 million for Q3, more than doubling compared to the prior year, with a 126% increase in new patient starts [31][10] - Gvoke generated $22.9 million in revenue for the quarter, a 29% increase year-over-year, with total prescriptions increasing by 20% [33][14] - Keveyis net revenue was $12.2 million for Q3, with a modest increase in the number of patients despite generic competition [34][18] Market Data and Key Metrics Changes - The Cushing syndrome marketplace is expanding rapidly, creating strong tailwinds for Recorlev, with increasing screenings and diagnoses of hypercortisolism [12][11] - Gvoke has a total addressable patient population of over 14 million people still unprotected, indicating significant market potential [16] Company Strategy and Development Direction - The company focuses on three strategic priorities: rapid growth of commercial franchises, enhancing financial discipline, and improving communication with stakeholders [8][19] - The company raised its revenue guidance for 2024 to $198 million to $202 million, reflecting confidence in continued growth [18][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trajectory of the business, particularly regarding top-line growth and strong margin profiles [50][52] - The company anticipates providing detailed financial guidance for 2025 in March, with a focus on key metrics that reflect long-term health [72][27] Other Important Information - The company ended Q3 with over $69 million in cash, allowing for growth investments without the need for dilutive financing [20][42] - Research and development expenses were $5.9 million for Q3, primarily for the pipeline product XP8121 and technology partnerships [38][39] Q&A Session Summary Question: What are the specific drivers for Recorlev's growth? - Management highlighted market growth and effective execution by the team in identifying patients with hypercortisolemia as key drivers [46][47] Question: What is the outlook for cash flow breakeven? - Management indicated confidence in achieving cash flow breakeven in Q4, with further updates expected in early 2025 [50][52] Question: Can you comment on the cost of goods sold and gross margin? - Management acknowledged a higher write-off in Q3 but expects gross margins to remain healthy as sales increase [56][57] Question: What is the long-term outlook for Keveyis? - Management expressed confidence in the durability of Keveyis despite generic competition, emphasizing patient retention and support services [88][90] Question: How does the competitive landscape affect Recorlev? - Management views increased awareness and recognition of cortisol's role in various conditions as beneficial for Recorlev, creating a favorable environment for growth [92]