Xeris Biopharma Holdings, Inc.

Previous wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and notes to those financial statements appearing elsewhere in this Quarterly Report on Form 10-Q and with the audited financial statements and the notes to those financial statements included in the Annual Report on Form 10-K filed on March 6, 2025 with the U.S. Securities and Exchange Commission. In addition to financial information, the following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. All statements in this document other than statements of historical fact are, or could be, "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "will," "would," "may," "should," "expects," "focus," "goal," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue," and terms of similar meaning are also generally intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including without limitation, the regulatory approval of our product candidates, including potential impacts of regulatory agency staffing cuts and reduced resources as well as shifting policy priorities and the impact on regulatory feedback and timing thereof, changes in macroeconomic conditions such as the possibility of an economic downturn or general economic uncertainty, our ability to market and sell our products and product candidates if approved, increasing geopolitical tensions and market volatility, including announced or implemented tariffs, and factors discussed in Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2024 and in our other subsequent filings with the U.S. Securities and Exchange Commission, including elsewhere in this Quarterly Report on Form 10-Q. Any forward-looking statements contained herein speak only as of the date hereof, and Xeris expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Current wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and notes to those financial statements appearing elsewhere in this Quarterly Report on Form 10-Q and with the audited financial statements and the notes to those financial statements included in the Annual Report on Form 10-K filed on March 6, 2025 with the U.S. Securities and Exchange Commission ("SEC"). In addition to financial information, the following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. All statements in this document other than statements of historical fact are, or could be, "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "will," "would," "may," "should," "expects," "focus," "goal," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue," and terms of similar meaning are also generally intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including without limitation, the regulatory approval of our product candidates, including potential impacts of regulatory agency staffing cuts and reduced resources as well as shifting policy priorities and the impact on regulatory feedback and timing thereof, changes in macroeconomic conditions such as the possibility of an economic downturn or general economic uncertainty, our ability to market and sell our products and product candidates if approved, increasing geopolitical tensions and market volatility, including announced or implemented tariffs, and factors discussed in Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2024 and in our other subsequent filings with the SEC, including elsewhere in this Quarterly Report on Form 10-Q. Any forward-looking statements contained herein speak only as of the date hereof, and Xeris expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Previous wording

•XP-8121: We are in the process of developing the first and only, once-weekly, subcutaneous injection of levothyroxine for the treatment of hypothyroidism. We are working with the FDA to plan and initiate a Phase 3 clinical trial of our XP-8121 product candidate.

Current wording

•XP-8121: We are in the process of developing the first and only, once-weekly, subcutaneous injection of levothyroxine for the treatment of hypothyroidism. We are working with the United States Food and Drug Administration ("FDA") to plan and initiate a Phase 3 clinical trial of our XP-8121 product candidate.

Previous wording

Our strategy is to build a profitable biopharmaceutical company focused on developing and commercializing therapies for people with chronic endocrine and neurological diseases. Xeris is uniquely positioned to execute on this strategy through the continued growth of our three commercial products, which enables us to invest in and develop therapies for unmet medical needs. We believe this will generate a value to all of our stakeholders.

Current wording

Our strategy is to build a profitable biopharmaceutical company focused on developing and commercializing therapies for people with chronic endocrine and neurological diseases. Xeris is uniquely positioned to execute on this strategy through the continued growth of our three commercial products, which enables us to invest in and develop therapies for unmet medical needs. We believe this will generate value to all of our stakeholders.

Previous wording

As of July 31, 2025, we owned 180 patents issued globally, including composition of matter patents covering our ready-to-use glucagon formulation that expire in 2036. Included in the total patents, we have 66 granted patents globally related to our platform technologies and eight patents granted in the United States and listed in the United States Food and Drug Administration ("FDA") Orange Book covering proprietary formulations of levoketoconazole (the active pharmaceutical ingredient in Recorlev) and the uses of such formulations in treating certain endocrine-related diseases and syndromes. The latter includes United States Patent Nos. 11,020,393, 11,278,547, and 11,903,940, which were granted on June 1, 2021, March 22, 2022, and February 20, 2024, respectively, and which provide patent protection through 2040 for the use of Recorlev in the treatment of certain patients with persistent or recurrent Cushing's syndrome.

Current wording

As of October 31, 2025, we owned 191 patents issued globally, including composition of matter patents covering our ready-to-use glucagon formulation that expire in 2036. Included in the total patents, we have 66 granted patents globally related to our platform technologies and nine patents granted in the United States and listed in the FDA Orange Book covering proprietary formulations of levoketoconazole (the active pharmaceutical ingredient in Recorlev) and the uses of such formulations in treating certain endocrine-related diseases and syndromes. The latter includes United States Patent Nos. 11,020,393, 11,278,547, 11,903,940, and 12,377,096, which were granted on June 1, 2021, March 22, 2022, February 20, 2024, and August 5, 2025, respectively, and which provide patent protection through 2040 for the use of Recorlev in the treatment of certain patients with persistent or recurrent Cushing's syndrome.

Previous wording

For the six months ended June 30, 2025 and June 30, 2024, we reported net losses of $11.1 million and $34.0 million, respectively. We have not been profitable since inception, and, as of June 30, 2025, our accumulated deficit was $683.0 million. In the near term, we expect to continue to incur net losses as we, among other things:

Current wording

For the nine months ended September 30, 2025 and September 30, 2024, we reported net losses of $10.5 million and $49.7 million, respectively. Our accumulated deficit was $682.4 million. In the near term, we may incur net losses as we, among other things:

Previous wording

The following discussion sets forth certain components of the statement of operations of Xeris for the three and six months ended June 30, 2025 and 2024 as well as factors that impact those items.

Current wording

The following discussion sets forth certain components of the statement of operations of Xeris for the three and nine months ended September 30, 2025 and 2024 as well as factors that impact those items.

Previous wording

The following table summarizes our results of operations for the three and six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our results of operations for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

Net revenue decreased by $1.6 million or 12.5% for the three months ended June 30, 2025 compared to the same period ended June 30, 2024. The decrease was due to lower volume ($2.7 million or 20.5%), offset by favorable net pricing ($1.1 million or 8.0%).

Current wording

Net revenue decreased by $0.3 million or 2.1% for the three months ended September 30, 2025 compared to the same period ended September 30, 2024. The decrease was due to unfavorable net pricing ($1.1 million or 8.8%) offset by higher volume ($0.8 million or 6.7%).

Previous wording

Net revenue decreased by $3.3 million or 12.6% for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. The decrease was due to lower volume ($5.4 million or 20.5%), offset by favorable net pricing ($2.1 million or 7.9%).

Current wording

Net revenue decreased by $3.6 million or 9.3% for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The decrease was due to unfavorable net pricing ($4.9 million or 12.6%), offset by higher volume ($1.3 million or 3.3%).

Previous wording

Other product revenue increased by $1.3 million for the three and six months ended June 30, 2025. This includes the sale of VialDx to American Regent following the recent approval of Gvoke VialDx for use as a diagnostic aid during certain radiological examinations.

Current wording

Other product revenue increased by $1.3 million for the nine months ended September 30, 2025. This includes the sale of Gvoke VialDx units to American Regent.

Previous wording

Cost of goods sold as a percent of total product revenue increased by 0.8%, to 17.6% for the three months ended June 30, 2025 compared to 16.7% for the same period ended June 30, 2024, primarily due to higher write-offs of Gvoke components as a result of manufacturing process changes required to support Gvoke capacity expansion efforts ($1.5 million or 2.2%), offset by higher sales of products with a lower cost of goods sold (1.4%).

Current wording

Cost of goods sold as a percent of total product revenue improved by 10.9%, to 14.8% for the three months ended September 30, 2025 compared to 25.7% for the same period ended September 30, 2024, primarily due to higher sales of products with a lower cost of goods sold ($3.1 million or 5.8%) and a reduction of Gvoke inventory write-offs ($2.0 million or 5.1%).

Previous wording

Cost of goods sold as a percent of total product revenue increased by 0.6%, to 16.4% for the six months ended June 30, 2025 compared to 15.9% for the same period ended June 30, 2024, primarily due to a one-time credit for Keveyis purchased in 2024 (1.9%), offset by higher sales of products with a lower cost of goods sold (1.3%).

Current wording

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 compared to 19.6% for the same period ended September 30, 2024, primarily due to higher sales of products with a lower cost of goods sold ($5.2 million or 3.7%).

Previous wording

The following table summarizes our research and development expenses by type for the three and six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes our research and development expenses by type for the three and nine months ended September 30, 2025 and 2024:

Previous wording

Selling, general and administrative expenses increased by $10.0 million or 12.8% for the six months ended June 30, 2025 compared to the same period ended June 30, 2024. This increase was primarily due to higher personnel related expense ($7.2 million), primarily due to investments made in the Recorlev commercial organization starting in the third quarter of 2024.

Current wording

Selling, general and administrative expenses increased $1.5 million or 3.3% for the three months ended September 30, 2025 compared to the same period ended September 30, 2024. This increase was due to incremental personnel related expenses.

Previous wording

Selling, general and administrative expenses increased by $4.4 million or 11.0% for the three months ended June 30, 2025 compared to the same period ended June 30, 2024. This increase was primarily due to higher personnel related expense ($3.1 million), primarily due to investments made in the Recorlev commercial organization starting in the third quarter of 2024.

Current wording

Selling, general and administrative expenses increased $11.5 million or 9.3% for the nine months ended September 30, 2025 compared to the same period ended September 30, 2024. This increase was primarily due to higher personnel related expense ($7.9 million), largely due to investments made in the Recorlev commercial organization starting in the third quarter of 2024.

Previous wording

For the three and six months ended June 30, 2025 and June 30, 2024, amortization of intangible assets were both $2.7 million and $5.4 million, respectively.

Current wording

For the three and nine months ended September 30, 2025 and September 30, 2024, amortization of intangible assets were both $2.7 million and $8.1 million, respectively.

Previous wording

For the three months ended June 30, 2025, interest expense decreased $0.6 million or 7.6% compared to the three months ended June 30, 2024. The decrease is primarily due to a lower principal amount of debt outstanding during the period.

Current wording

For the three months ended September 30, 2025, interest expense decreased $0.5 million or 6.7% compared to the three months ended September 30, 2024. The decrease is primarily due to a lower principal amount of debt outstanding during the period.

Previous wording

For the six months ended June 30, 2025, interest expense decreased $0.3 million or 2.2% compared to the six months ended June 30, 2024. The decrease is primarily due to a lower principal amount of debt outstanding during the period.

Current wording

For the nine months ended September 30, 2025, interest expense decreased $0.9 million or 3.7% compared to the nine months ended September 30, 2024. The decrease is primarily due to a lower principal amount of debt outstanding during the period.

Previous wording

In May 2022, we entered into an Open Market Sale Agreement with Jefferies LLC, as agent, dated May 11, 2022 ("Sales Agreement") for the offering, issuance and sale of up to a maximum aggregate offering price of $75.0 million of common stock. The Sales Agreement will terminate upon the earlier of (i) the sale of all shares of common stock subject to the Sales Agreement and (ii) the termination of the Sales Agreement as permitted therein. Either party may each terminate the Sales Agreement at any time upon ten days’ prior notice. To date, we have not sold any shares pursuant to the Sales Agreement.

Current wording

In May 2022, we entered into an Open Market Sale Agreement with Jefferies LLC, as agent, dated May 11, 2022 ("Sales Agreement") for the offering, issuance and sale of up to a maximum aggregate offering price of $75.0 million of our common stock. The Sales Agreement will terminate upon the earlier of (i) the sale of all shares of common stock subject to the Sales Agreement and (ii) the termination of the Sales Agreement as permitted therein. Either party may each terminate the Sales Agreement at any time upon ten days’ prior notice. To date, we have not sold any shares pursuant to the Sales Agreement.

Previous wording

We have incurred operating losses since inception, and we have an accumulated deficit of $683.0 million at June 30, 2025. Based on our current operating plans and existing working capital at June 30, 2025, we believe that our cash resources are sufficient to sustain operations and capital expenditure requirements for at least the next twelve months. We expect to incur substantial additional expenditures in the near term to support the marketing and selling of Recorlev, Gvoke and Keveyis as well as our ongoing research and development activities. We expect to continue to incur net losses for at least the next twelve months. Our ability to fund the marketing and selling of Recorlev, Gvoke and Keveyis, as well as our product development and clinical operations, including completion of future clinical trials, will depend on the amount and timing of cash received from product revenue and potential future financings. Our future capital requirements will depend on many factors, including, but not limited to:

Current wording

We have an accumulated deficit of $682.4 million at September 30, 2025. Based on our current operating plans and existing working capital at September 30, 2025, we believe that our cash resources are sufficient to sustain operations and capital expenditure requirements for at least the next twelve months. We expect to incur substantial additional expenditures in the near term to support the marketing and selling of Recorlev, Gvoke and Keveyis as well as our ongoing research and development activities. We expect to continue to incur net losses for at least the next twelve months. Our ability to fund the marketing and selling of Recorlev, Gvoke and Keveyis, as well as our product development and clinical operations, including completion of future clinical trials, will depend on the amount and timing of cash received from product revenue and potential future financings. Our future capital requirements will depend on many factors, including, but not limited to:

Previous wording

Net cash used in operating activities was$9.8 million for the six months ended June 30, 2025, compared to $30.7 million for the six months ended June 30, 2024. The decrease in net cash used in operating activities was primarily driven by higher sales. For a discussion regarding product revenue, net and increases in spending, refer to "Results of Operations" included in this "Item 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations" of Part I of this Quarterly Report on Form 10-Q.

Current wording

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 nine months ended September 30, 2024. The increase in net cash provided by operating activities was primarily driven by higher product sales. For a discussion regarding product revenue, net and increases in spending, refer to "Results of Operations" included in this "Item 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations" of Part I of this Quarterly Report on Form 10-Q.

Previous wording

Net cash used in investing activities was$292.0 thousand for the six months ended June 30, 2025, compared to $15.0 million for the six months ended June 30, 2024. The decrease in cash used by investing activities for thesix months ended June 30, 2025 was due to fewer purchases of short-term investments.

Current wording

Net cash used in investing activities was$363.0 thousand for the nine months ended September 30, 2025, compared to $5.1 million used in investing activities for the nine months ended September 30, 2024. The decrease in cash used by investing activities for thenine months ended September 30, 2025 was due to fewer purchases of short-term investments.

Previous wording

Net cash used in financing activities was$2.2 million for the six months ended June 30, 2025, compared to $35.9 million provided by financing activities for the six months ended June 30, 2024. The cash used by financing activities in the six months ended June 30, 2025 was driven by repurchases of common stock withheld for taxes and the proceeds from the exercise of stock awards. The cash provided by financing activities in the six months ended June 30, 2024 was primarily due to the net proceeds of $38.2 million from the term loan made to the Company on the closing date of the Amended and Restated Credit Agreement.

Current wording

Net cash provided by financing activities was$11.7 million for the nine months ended September 30, 2025, compared to $35.8 million provided by financing activities for the nine months ended September 30, 2024. The net cash provided by financing activities for the nine months ended September 30, 2025 was driven by proceeds from the exercise of stock awards and issuance of common shares in settlement of warrants of $20.2 million offset by repurchase of common stock withheld for taxes of $9.3 million. The net cash provided by financing activities in the nine months ended September 30, 2024 was primarily due to the net proceeds of $38.2 million from the term loan made to the Company on the closing date of the Amended and Restated Credit Agreement.