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 ...

Financial Data and Key Metrics Changes - Total revenue for 2024 was over $203 million, growing 24% year-over-year, driven by strong demand for Recorlev and Gvoke [8][14] - Net product revenue for Q4 2024 was $57 million, marking a 34% increase compared to the prior year [28] - Adjusted EBITDA turned positive in Q4 2024, with expectations to remain positive going forward [15][43] Business Line Data and Key Metrics Changes - Recorlev achieved $64.3 million in revenue for 2024, a 118% increase compared to 2023, with Q4 revenue of $22.6 million, up 131% year-over-year [9][28] - Gvoke generated nearly $83 million in revenue for 2024, a 24% increase, with Q4 revenue of $23.3 million, also a 25% increase [10][30] - Keveyis ended 2024 with approximately $50 million in revenue, a 13% decline year-over-year, but maintained a steady patient base [11][36] Market Data and Key Metrics Changes - The market for hypercortisolemia is expanding, with increasing diagnoses leading to more patients being treated [16][17] - Gvoke targets a large untapped market, with an estimated 14 million patients unprotected by life-saving therapies [18][19] Company Strategy and Development Direction - The company aims for total revenue between $255 million and $275 million in 2025, representing over 30% year-over-year growth at the midpoint [14][36] - Strategic priorities include driving growth of commercial products, maintaining financial discipline, and enhancing communication with stakeholders [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth, particularly for Recorlev and Gvoke, while anticipating steady demand for Keveyis [36][38] - The company is focused on leveraging its existing commercial capabilities for the development of XP-8121, a new product for hypothyroidism [25][102] Other Important Information - The company reported a gross margin of 84% in Q4 2024, a 1% improvement year-over-year, driven by a favorable product mix [32] - The company ended 2024 with a healthy cash position of $71.6 million [35] Q&A Session Summary Question: Recorlev strength and prescriber growth - Management noted both expansion of the writer base and increased prescriptions from existing prescribers contributing to Recorlev's growth [47] Question: Year-over-year prescription growth in hypercortisolism - Management indicated a lack of specific data on market growth but emphasized the importance of field efforts to identify patients [49] Question: Expectations for Keveyis in 2025 - Management suggested Keveyis may have found its bottom, with expectations to hold steady despite potential pressures on reimbursement [54] Question: Long-term spend to support Recorlev - Management acknowledged the need for continued investment in Recorlev, with a focus on expanding awareness and treatment [81][88] Question: Durability and exclusivity runway for Recorlev - Patents for Recorlev extend to 2040, with orphan exclusivity through 2028, providing a significant runway for growth [84][86] Question: Gvoke and updated guidelines - Management is focused on raising awareness of new guidelines to protect unprotected patients, viewing it as a long-term opportunity [94] Question: Phase 3 readiness for XP-8121 - Management confirmed plans for Phase 3 readiness, with potential clinical trials starting in 2026 [95]

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]

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 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]

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]

Core Insights - Xeris Biopharma reported $54.27 million in revenue for Q3 2024, marking a 12.3% year-over-year increase and a 5.09% surprise over the Zacks Consensus Estimate of $51.64 million [1] - The company posted an EPS of -$0.06, which is an improvement from -$0.09 a year ago, resulting in a 33.33% EPS surprise compared to the consensus estimate [1] Revenue Breakdown - Gvoke product revenue was $22.94 million, slightly below the estimated $22.97 million [3] - Keveyis product revenue reached $12.19 million, compared to the estimated $12.50 million [3] - Recorlev product revenue was $17.73 million, exceeding the estimated $15.07 million [3] - Total net product revenue was $52.86 million, surpassing the estimated $50.53 million [3] - Revenue from royalties, contracts, and other sources was $1.41 million, exceeding the estimated $0.93 million [3] Stock Performance - Xeris Biopharma shares have increased by 20.9% over the past month, outperforming the Zacks S&P 500 composite, which rose by 4.9% [4] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [4]