Xeris Biopharma Holdings, Inc.

Previous wording

•Recorlevis a cortisol synthesis inhibitor approved for the treatment of endogenous hypercortisolemia in adult patients with Cushing's syndrome for whom surgery is not an option or has not been curative. Endogenous Cushing's syndrome is a rare but serious and potentially fatal endocrine disease caused by chronic elevated cortisol exposure. The estimated total addressable market for this therapy is approximately $3.0 billion in the United States.

Current wording

•Recorlevis a cortisol synthesis inhibitor approved for the treatment of endogenous hypercortisolemia in adult patients with Cushing's syndrome for whom surgery is not an option or has not been curative. Endogenous Cushing's syndrome is a rare but serious and potentially fatal endocrine disease caused by chronic elevated cortisol exposure.

Previous wording

•Gvokeis a ready-to-use, liquid-stable glucagon for the treatment of severe hypoglycemia. The product is indicated for use in pediatric and adult patients with diabetes age 2 years and above and can be administered in 2 simple steps. The estimated total addressable market for this drug is approximately $5.0 billion in the United States.

Current wording

•Gvokeis a ready-to-use, liquid-stable glucagon for the treatment of severe hypoglycemia. The product is indicated for use in pediatric and adult patients with diabetes age 2 years and above and can be administered in 2 simple steps.

Previous wording

•Keveyis is the first therapy approved in the United States to treat hyperkalemic, hypokalemic, and related variants of PPP. PPP is a rare genetic, neuromuscular disorder that can cause extreme muscle weakness and/or paralysis; some forms are also commonly associated with myotonia or muscle stiffness. The estimated total addressable market for this therapy is greater than $0.5 billion in the United States.

Current wording

•Keveyis is the first therapy approved in the United States to treat hyperkalemic, hypokalemic, and related variants of PPP. PPP is a rare genetic, neuromuscular disorder that can cause extreme muscle weakness and/or paralysis; some forms are also commonly associated with myotonia or muscle stiffness.

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. The estimated total addressable market for this therapy is 3-5 million patients or more in the United States which we estimate is a $1.0 billion or greater market opportunity.

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 FDA to plan and initiate a Phase 3 clinical trial of our XP-8121 product candidate.

Previous wording

We currently own 167 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 8 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 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.

Previous wording

For the three months ended March 31, 2025 and March 31, 2024, we reported net losses of $9.2 million and $19.0 million, respectively. We have not been profitable since inception, and, as of March 31, 2025, our accumulated deficit was $681.1 million. In the near term, we expect to continue to incur significant expenses, operating losses and net losses as we, among other things:

Current 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:

Previous wording

The following discussion sets forth certain components of the statement of operations of Xeris for the three months ended March 31, 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 six months ended June 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 months ended March 31, 2025 and 2024 (in thousands):

Current wording

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

Previous wording

Net revenue increased by $14.9 million or 140.9% for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The increase was due to higher volume ($16.6 million or 156.6%), primarily driven by prescription growth, offset by unfavorable net pricing ($1.7 million or 15.7%).

Current wording

Net revenue increased by $18.1 million or 135.7% for the three months ended June 30, 2025 compared to the same period ended June 30, 2024. The increase was due to higher volume ($18.8 million or 141.3%), primarily driven by prescription growth, offset by unfavorable net pricing ($0.7 million or 5.6%).

Previous wording

Net revenue decreased by $1.7 million or 12.7% for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The decrease was due to unfavorable net pricing ($2.3 million or 17.0%), offset by higher volume ($0.6 million or 4.3%).

Current 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%).

Previous wording

Cost of goods sold increased by $2.8 million or 46.2% for the three months ended March 31, 2025 compared to the three months ended March 31, 2024.

Current wording

Cost of goods sold increased by $4.1 million or 52.7% and $6.9 million or 49.9% for the three and six months ended June 30, 2025 compared to the same periods ended June 30, 2024, respectively.

Previous wording

Cost of goods sold as a percent of total product revenue increased by 0.3%, to 15.1% for the three months ended March 31, 2025 compared to 14.8% for the same period ended March 31, 2024, primarily due to a one-time credit for Keveyis purchased in 2024 (4.1%), offset by higher sales of products with a lower cost of goods sold (3.8%).

Current 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%).

Previous wording

The following table summarizes our research and development expenses by type for the three months ended March 31, 2025 and 2024:

Current wording

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

Previous wording

Selling, general and administrative expenses increased by $5.6 million or 14.7% for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. This increase was primarily due to higher personnel related expense ($4.1 million), primarily due to investments made in the Recorlev commercial organization starting in the third quarter 2024.

Current 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.

Previous wording

For the three months ended March 31, 2025 and March 31, 2024, amortization of intangible assets were both $2.7 million.

Current 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.

Previous wording

For the three months ended March 31, 2025, interest expense increased $0.3 million or 3.9% compared to the three months ended March 31, 2024. The increase is primarily due to a higher principal amount and increased interest rates.

Current 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.

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 and we are unable to make sales under the Sales Agreement until a new Shelf Registration Statement is declared effective, a prospectus relating to the sales pursuant to the Sales Agreement is filed and we take certain steps in accordance with the terms of 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 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

In March 2024, we entered into an Amended and Restated Credit Agreement and Guaranty (the "Amended and Restated Credit Agreement") with the lenders from time to time parties thereto (the "Lenders") and Hayfin Services LLP, as administrative agent for the New Lenders, pursuant to which we and our subsidiaries granted a first priority security interest on substantially all of our assets, including intellectual property, subject to certain exceptions. The Amended and Restated Credit Agreement provides for the Lenders to extend $200.0 million in term loans to the Company on the closing date and up to an additional $15.2 million in additional term loans, which additional term loans are available only to redeem the Company's 2025 Convertible Notes.

Current wording

In March 2024, we entered into an Amended and Restated Credit Agreement and Guaranty (the "Amended and Restated Credit Agreement") with the lenders from time to time parties thereto (the "Lenders") and Hayfin Services LLP, as administrative agent for the New Lenders, pursuant to which we and our subsidiaries granted a first priority security interest on substantially all of our assets, including intellectual property, subject to certain exceptions. The Amended and Restated Credit Agreement provides for the Lenders to extend $200.0 million in term loans to the Company on the closing date and up to an additional $15.2 million in additional term loans, which additional term loans are available only to redeem the Company's then outstanding 2025 Convertible Notes.

Previous wording

In March 2025, certain holders of our 2025 Convertible Senior Notes converted $3.2 million in aggregate principal amount of the notes into 1,045,751 shares of the Company's common stock. As of March 31, 2025, the outstanding balance of the 2025 Convertible Notes was $12.0 million and the outstanding balance of the 2028 Convertible Notes was $33.6 million.

Current wording

In March and April of 2025, holders of the 2025 Convertible Senior Notes converted the outstanding $15.2 million in aggregate principal amount of the notes into 4,978,152 shares of the Company's common stock. As of June 30, 2025, the outstanding balance of the 2028 Convertible Notes was $33.6 million.

Previous wording

We have incurred operating losses since inception, and we have an accumulated deficit of $681.1 million at March 31, 2025. Based on our current operating plans and existing working capital at March 31, 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 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:

Previous wording

Net cash used in operating activities was$10.0 million for the three months ended March 31, 2025, compared to $20.3 million for the three months ended March 31, 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 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.

Previous wording

Net cash used in investing activities was$13.0 thousand for the three months ended March 31, 2025, compared to $19.7 million for the three months ended March 31, 2024. The decrease in cash used by investing activities for thethree months ended March 31, 2025 was due to fewer purchases of short-term investments.

Current 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.

Previous wording

Net cash used in financing activities was$3.1 million for the three months ended March 31, 2025, compared to $35.2 million provided by financing activities for the three months ended March 31, 2024. The cash used by financing activities in the three months ended March 31, 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 three months ended March 31, 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 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.