Shares of Xeris Biopharma Holdings, Inc. (NASDAQ:XERS) are falling Friday after the company announced a patent infringement lawsuit to protect its drug, Recorlev.Xeris Biopharma Holdings stock is taking a hit today. What’s weighing on XERS shares?Lawsuit Targets Two Pharmaceutical CompaniesThe lawsuit, filed by Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited, targets unauthorized generic versions of Recorlev. The lawsuit names Torrent Pharmaceuticals Limited and Somerset Therapeutics, LLC as the ...

CHICAGO--(BUSINESS WIRE)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, announced that its subsidiaries, Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited, have filed a patent infringement lawsuit under the Hatch-Waxman Act related to Recorlev® (levoketoconazole) in the United States District Court for the District of New Jer. ...

The upcoming report from Xeris Biopharma (XERS) is expected to reveal quarterly earnings of $0.03 per share, indicating an increase of 200% compared to the year-ago period. Analysts forecast revenues of $81.43 million, representing an increase of 35.5% year over year.Over the past 30 days, the consensus EPS estimate for the quarter has remained unchanged. This demonstrates the covering analysts' collective reassessment of their initial projections during this period.Prior to a company's earnings release, it ...

CHICAGO--(BUSINESS WIRE)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that the Company will release its fourth quarter and full year 2025 financial results before the open of the U.S. financial markets on Monday, March 2, 2026. Management will host a conference call and webcast at 8:30 a.m. Eastern Time that day to di. ...

Core Insights - The article discusses the investment potential of XERS, highlighting a beneficial long position in its shares by the analyst [1]. Group 1 - The analyst expresses a personal opinion on XERS without receiving compensation from the company [1]. - There is an emphasis on the uncertainty of financial predictions and projections, which are merely median estimates [2]. - The article clarifies that past performance does not guarantee future results, and no specific investment advice is provided [3].

Core Viewpoint - Xeris Biopharma Holdings, Inc. has granted restricted stock units to new employees as part of its Inducement Equity Plan, indicating a commitment to attract talent and enhance its workforce [1] Group 1: Company Actions - On January 2, 2026, Xeris granted restricted stock units for a total of 181,550 shares of common stock to 50 new employees [1] - The stock grants are part of Xeris' Inducement Equity Plan, which aims to incentivize and retain key personnel [1]

Summary of Xeris Biopharma Holdings FY Conference Call Company Overview - **Company**: Xeris Biopharma Holdings (NasdaqGS:XERS) - **Industry**: Biopharmaceuticals - **Products**: Gvoke HypoPen, Keveyus, Recorlev - **Growth**: The company has raised its revenue guidance to $285 million-$290 million, reflecting a 42% growth at the midpoint [2][3] Core Insights Financial Performance - **Gross Margins**: The company reports 85% gross margins, which are improving [2] - **EBITDA**: Adjusted EBITDA became positive a year ago, with net income reported for the first time last quarter [3] Product Focus: Recorlev - **Market Awareness**: Increased screening for hypercortisolism among endocrinologists is driving Recorlev's growth, particularly in patients with uncontrolled type 2 diabetes and hypertension [4][5] - **Patient Demographics**: Patients treated with Recorlev have hypercortisolemia, with cortisol levels 1.8 times or higher than normal, often accompanied by conditions like diabetes or obesity [6] - **Sales Force Expansion**: The sales force was increased by 50% in August 2024 and is set to double by January 2026, targeting 12,000 physicians [10][11] - **Payer Access**: The focus is on demonstrating medical necessity for patients with hypercortisolemia to facilitate access [16] - **Competitive Landscape**: The entry of Corcept's relacorilant is seen as beneficial for overall market awareness, with no expected disruption to Recorlev's sales [18][20] Product Focus: Gvoke - **Market Penetration**: Gvoke is primarily used in type 1 diabetes, with efforts ongoing to increase awareness among clinicians regarding its necessity for patients on insulin or sulfonylurea [26][30] - **Payer Access**: Over 80% access is reported, with the main challenge being clinician awareness rather than payer issues [33] - **Competitive Dynamics**: The market can accommodate both Gvoke and Baqsimi without significant competitive disruption [36] Product Focus: Keveyus - **Market Position**: Despite generic competition, Keveyus maintains steady sales around $11 million per quarter due to comprehensive patient support services [41] Pipeline Product: XP-8121 - **Market Opportunity**: Targeting 3-5 million patients who cannot achieve normal thyroid levels due to GI absorption issues, with a projected market opportunity of $1 billion-$3 billion [43][49] - **Phase 3 Trial**: A phase 3 trial is planned for late 2026, aiming to establish therapeutic equivalence to daily oral levothyroxine [50] Additional Insights - **Intellectual Property**: Xeris holds multiple patents for Recorlev, with protections extending to 2040, which strengthens its market position against generics [22][23] - **Acquisition Strategy**: The company is open to acquiring assets that can leverage its existing commercial infrastructure, targeting $750 million in revenue by 2030 [54] Conclusion Xeris Biopharma is positioned for significant growth driven by its key products, particularly Recorlev, with a strong focus on expanding its market presence and enhancing patient access. The company is also strategically planning for future product launches and potential acquisitions to bolster its portfolio.

Revenue Growth - For the three months ended September 30, 2025, net product revenue increased by $21.2 million or 40.1% to $74.1 million compared to $52.9 million for the same period in 2024[134]. - Recorlev's net revenue rose by $19.2 million or 108.6% for the three months ended September 30, 2025, primarily due to increased patient demand, despite a $1.4 million unfavorable net pricing impact[135]. - Gvoke's net revenue increased by $2.2 million or 9.6% for the three months ended September 30, 2025, reaching $25.2 million compared to $22.9 million in the same period of 2024[134]. - Total revenue for the nine months ended September 30, 2025, was $206.0 million, an increase of $63.1 million or 44.1% compared to $143.0 million for the same period in 2024[134]. - Net revenue increased by $52.3 million or 125.5% for the nine months ended September 30, 2025, primarily driven by higher volume of $56.3 million or 135.1%[136]. - Gvoke's net revenue increased by $2.2 million or 9.6% for the three months ended September 30, 2025, due to higher volume of $0.6 million or 2.7% and favorable net pricing of $1.6 million or 6.9%[137]. - Keveyis' net revenue decreased by $0.3 million or 2.1% for the three months ended September 30, 2025, due to unfavorable net pricing of $1.1 million or 8.8%[139]. Expenses - Research and development expenses for the three months ended September 30, 2025, were $7.5 million, an increase of $1.6 million or 27.1% compared to $5.9 million in the same period of 2024[134]. - Selling, general and administrative expenses for the three months ended September 30, 2025, were $46.5 million, an increase of $1.5 million or 3.3% compared to $45.0 million in the same period of 2024[134]. - Research and development expenses increased by $3.8 million or 19.6% for the nine months ended September 30, 2025, with project-specific expenses for pipeline increasing by $1.4 million or 25.6%[145]. - Selling, general and administrative expenses increased by $11.5 million or 9.3% for the nine months ended September 30, 2025, primarily due to higher personnel-related expenses of $7.9 million[147]. Net Loss and Financial Position - The company reported a net loss of $15.7 million for the nine months ended September 30, 2025, compared to a net loss of $49.7 million for the same period in 2024, reflecting a decrease of $34.0 million or 68.4%[134]. - The accumulated deficit as of September 30, 2025, was $682.4 million, indicating ongoing financial challenges despite revenue growth[121]. - The company has an accumulated deficit of $682.4 million as of September 30, 2025, and expects to incur substantial additional expenditures in the near term[157]. Cash Flow - Net cash provided by operating activities was $8.6 million for the nine months ended September 30, 2025, compared to $39.0 million used in operating activities for the same period in 2024[161]. - Net cash provided by financing activities was $11.7 million for the nine months ended September 30, 2025, driven by proceeds from the exercise of stock awards and issuance of common shares[163]. Patents and Clinical Trials - As of October 31, 2025, the company owned 191 patents globally, including key patents for its glucagon formulation expiring in 2036[120]. - The company plans to initiate a Phase 3 clinical trial for XP-8121, a once-weekly subcutaneous injection of levothyroxine for hypothyroidism[118]. Cost of Goods Sold - Cost of goods sold as a percent of total product revenue improved by 3.8%, to 15.8% for the nine months ended September 30, 2025, primarily due to higher sales of products with a lower cost of goods sold[144]. Foreign Currency Risk - The company is exposed to foreign currency exchange risk due to contracts with organizations outside the United States[169]. - Net foreign currency gains and losses did not have a material effect on the company's results of operations for the three and nine months ended September 30, 2025[169]. Interest Expense - Interest expense decreased by $0.9 million or 3.7% for the nine months ended September 30, 2025, primarily due to a lower principal amount of debt outstanding[150].

Financial Data and Key Metrics Changes - Total product revenue for Q3 2025 exceeded $74 million, representing a 40% increase year over year [4] - The company raised the lower end of its full-year total revenue guidance to a range of $285-$290 million, indicating a 42% increase at the midpoint compared to 2024 [4][12] - Gross margin improved to 85%, driven primarily by an improved product mix [11] - For the first time in the company's history, it reported quarterly net income [9][11] Business Line Data and Key Metrics Changes - Recorlev generated revenue of $37 million in Q3, a year-over-year increase of 109%, with the average number of patients on therapy growing by 108% [5][10] - Gvoke delivered revenue of more than $25 million, up nearly 10% from the same period last year, driven by a 5% increase in total prescriptions [6][10] - Keveyis achieved quarterly revenue of approximately $12 million, supported by new patient additions [6][10] Market Data and Key Metrics Changes - The company continues to expand its prescriber base for Recorlev, reflecting strong demand in the hypercortisolemia and Cushing's syndrome market [5][7] - The average number of patients on therapy for Keveyis increased, indicating a healthy pace of new patient starts [10] Company Strategy and Development Direction - The company is focused on expanding its commercial footprint to capture significant opportunities for Recorlev while strengthening operational capabilities for scalable growth in 2026 and beyond [7] - The strategic expansion includes nearly doubling the sales and patient support teams [7] - The company is advancing its pipeline with XP-8121, a once-weekly subcutaneous form of levothyroxine, with plans to initiate a phase three clinical trial in the second half of 2026 [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing demand for therapies and the company's ability to deliver strong performance [9][12] - The company anticipates continued growth for Recorlev, with expectations of it becoming a billion-dollar product [21] - Management emphasized the importance of maintaining positive adjusted EBITDA while making incremental investments in growth opportunities [12][24] Other Important Information - The company is committed to remaining adjusted EBITDA positive despite increased spending on R&D and SG&A [12][24] - Management highlighted the importance of a disciplined approach to investments in technology and infrastructure to support future growth [29] Q&A Session Summary Question: Impact of expanded sales force on Recorlev productivity - The sales force for Recorlev was increased by 50%, and productivity is expected to ramp up in the first half of the year [15][16] Question: Discontinuation rates for Recorlev - There have been no significant changes in dropout rates, with new patient starts overwhelming any metrics [19][20] Question: Competitive dynamics with potential new entrants - Management views the potential approval of competitors as an opportunity to expand the market for hypercortisolemia treatments [40][41] Question: Plans to target general practitioners for Recorlev - The company plans to expand its commercial footprint to include general practitioners as part of its data-driven approach [41][42] Question: Durability of the Keveyis franchise - The company continues to see strong performance from Keveyis, with ongoing efforts to support patient treatment and retention [45]

Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Company Overview: Xeris Biopharma (XERS) - Xeris Biopharma currently holds a Momentum Style Score of A, indicating strong potential for momentum investing [3] - The company has a Zacks Rank of 2 (Buy), which is associated with a historical outperformance when combined with a strong Style Score [4] Price Performance - XERS shares have increased by 15.64% over the past week, while the Zacks Medical - Drugs industry remained flat [6] - Over the past month, XERS has shown a price change of 19.69%, significantly outperforming the industry's 0.1% [6] - In the last quarter, XERS shares rose by 84.06%, and over the past year, they have gained 201.96%, compared to the S&P 500's increases of 6.14% and 15.41%, respectively [7] Trading Volume - The average 20-day trading volume for XERS is 2,208,657 shares, which serves as a bullish indicator when combined with rising stock prices [8] Earnings Outlook - In the past two months, one earnings estimate for XERS has increased, while none have decreased, leading to a consensus estimate improvement from -$0.03 to -$0.01 [10] - For the next fiscal year, one estimate has moved upwards with no downward revisions, indicating positive sentiment [10] Conclusion - Considering the strong price performance, trading volume, and positive earnings outlook, Xeris Biopharma is positioned as a promising momentum pick with a 2 (Buy) rating and a Momentum Score of A [12]