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Xeris Biopharma Holdings, Inc.
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2024-08-13
Xeris Biopharma Holdings, Inc.
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Xeris Biopharma Holdings, Inc.
Response Received
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2024-06-12
Xeris Biopharma Holdings, Inc.
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2024-06-21
Xeris Biopharma Holdings, Inc.
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2024-08-06
Xeris Biopharma Holdings, Inc.
References: July 22, 2024 | June 21, 2024
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2024-07-22
Xeris Biopharma Holdings, Inc.
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Response Received
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2022-02-01
Xeris Biopharma Holdings, Inc.
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2022-02-04
Xeris Biopharma Holdings, Inc.
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2022-02-04
Xeris Biopharma Holdings, Inc.
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2022-02-01
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Response Received
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2021-07-09
Xeris Biopharma Holdings, Inc.
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2021-07-28
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-09 | Company Response | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| 2025-03-11 | SEC Comment Letter | Xeris Biopharma Holdings, Inc. | N/A | 333-285597 | Read Filing View |
| 2024-08-13 | SEC Comment Letter | Xeris Biopharma Holdings, Inc. | N/A | 001-40880 | Read Filing View |
| 2024-08-06 | Company Response | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| 2024-07-22 | SEC Comment Letter | Xeris Biopharma Holdings, Inc. | N/A | 001-40880 | Read Filing View |
| 2024-06-21 | Company Response | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| 2024-06-12 | SEC Comment Letter | Xeris Biopharma Holdings, Inc. | N/A | 001-40880 | Read Filing View |
| 2022-02-04 | Company Response | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| 2022-02-04 | Company Response | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| 2022-02-01 | SEC Comment Letter | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| 2022-02-01 | SEC Comment Letter | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| 2021-07-28 | Company Response | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| 2021-07-09 | SEC Comment Letter | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-11 | SEC Comment Letter | Xeris Biopharma Holdings, Inc. | N/A | 333-285597 | Read Filing View |
| 2024-08-13 | SEC Comment Letter | Xeris Biopharma Holdings, Inc. | N/A | 001-40880 | Read Filing View |
| 2024-07-22 | SEC Comment Letter | Xeris Biopharma Holdings, Inc. | N/A | 001-40880 | Read Filing View |
| 2024-06-12 | SEC Comment Letter | Xeris Biopharma Holdings, Inc. | N/A | 001-40880 | Read Filing View |
| 2022-02-01 | SEC Comment Letter | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| 2022-02-01 | SEC Comment Letter | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| 2021-07-09 | SEC Comment Letter | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-09 | Company Response | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| 2024-08-06 | Company Response | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| 2024-06-21 | Company Response | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| 2022-02-04 | Company Response | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| 2022-02-04 | Company Response | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
| 2021-07-28 | Company Response | Xeris Biopharma Holdings, Inc. | N/A | N/A | Read Filing View |
2025-05-09 - CORRESP - Xeris Biopharma Holdings, Inc.
CORRESP 1 filename1.htm Document May 9, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Xeris Biopharma Holdings, Inc. Acceleration Request for Registration Statement on Form S-3 (File No. 333-285597) Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Act ”), Xeris Biopharma Holdings, Inc. (the “ Company ”) hereby requests that the effective date of the above-referenced registration statement be accelerated to May 13, 2025, at 4:01 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. If you have any questions regarding this request, please contact Joseph C. Theis, Jr., of Goodwin Procter LLP at (617) 570-1928. Sincerely, Xeris Biopharma Holdings, Inc. /s/ John P. Shannon Name: John P. Shannon Title: Director and Chief Executive Officer Cc: Joseph C. Theis, Jr., Esq., Goodwin Procter LLP
2025-03-11 - UPLOAD - Xeris Biopharma Holdings, Inc. File: 333-285597
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 11, 2025 John P. Shannon Director and Chief Executive Officer Xeris Biopharma Holdings, Inc. 1375 West Fulton Street, Suite 1300 Chicago, IL 60607 Re: Xeris Biopharma Holdings, Inc. Registration Statement on Form S-3 Filed March 6, 2025 File No. 333-285597 Dear John P. Shannon: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Daniel Crawford at 202-551-7767 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Joe Theis, Esq. </TEXT> </DOCUMENT>
2024-08-13 - UPLOAD - Xeris Biopharma Holdings, Inc. File: 001-40880
August 13, 2024
Steven Pieper
Chief Financial Officer
Xeris Biopharma Holdings, Inc.
1375 West Fulton Street, Suite 100
Chicago, IL 60607
Re:Xeris Biopharma Holdings, Inc.
Form 10-K for the year ended December 31, 2023
Form 10-Q for the quarterly period ended March 31, 2024
File No. 001-40880
Dear Steven Pieper:
We have completed our review of your filings. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2024-08-06 - CORRESP - Xeris Biopharma Holdings, Inc.
CORRESP 1 filename1.htm filename 1375 West Fulton Street, Suite 1300, Chicago IL 60607 August 6, 2024 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, DC 20549 Attention: Vanessa Robertson Kevin Vaughn Re: Xeris Biopharma Holdings, Inc. Form 10-K for the year ended December 31, 2023 Form 10-Q for the quarterly period ended March 31, 2024 File No. 001-40880 To the addressees set forth above: On behalf of Xeris Biopharma Holdings, Inc. (the “Company”), set forth below is the Company’s response to the comments received from the Staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission in its letter to the Company dated July 22, 2024 relating to the Company’s Form 10-K for the fiscal year ended December 31, 2023, filed on March 6, 2024 (the “Form 10-K”), and the Form 10-Q for the quarterly period ended March 31, 2024 , filed on May 9, 2024 (the “Form 10-Q”). For your convenience, each response below is prefaced by the exact text of the Staff’s corresponding comment. Form 10-Q for the quarterly period ended March 31, 2024 Management's Discussion Analysis of Financial Condition and Results of Operations, page 21 1. Your proposed disclosures in response to prior comment one say that "Cost of goods sold as a percent of total revenue decreased by 3.0%, or 17.5% in 2023 compared to 20.5% in 2022. This decrease was primarily due to collaboration agreements, specifically upfront and milestone achievements resulting in revenue." However, cost of goods sold as percent of product revenue for 2023 was 18.7% compared to 20.7% for 2022. Revise your proposed disclosure to explain the reasons for the decrease in cost of goods sold as a percent of product revenue. Response to Comment No. 1: The Company respectfully acknowledges the Staff’s comment and advises the Staff that in future filings, beginning with its Form 10-Q for the quarter ending June 30, 2024, the Company will revise its disclosure to include the Staff’s comment above. • For illustrative purposes, we have quantified the changes in cost of goods sold as a percentage of product revenue instead of total revenue. • Cost of goods sold as a percent of product revenue decreased by 2.0%, or 18.7% in 2023 compared to 20.7% in 2022. This decrease was primarily due to an increase in Recorlev revenue resulting in a product mix with lower costs (0.8%) and a one-time contract credit in the first quarter of 2023 (0.7%). Form 10-Q for the quarterly period ended March 31, 2024 Management's Discussion and Analysis of Financial Condition and Results of Operations Results of Operations, page 21 2. Please address the following regarding your response to prior comment two and your proposed related disclosures: • You disclose on page 70 of your Form 10-K that the increase in research and development expenses from 2022 to 2023 was driven by the expenses related to the Phase 2 study for XP-8121. In your Form 10-Q for quarter ended March 31, 2024, you disclose that the increase in research and development expenses was "driven by strategic investments in our pipeline, notably XP-8121, and our emerging technology partnership business as well as higher personnel costs." Please confirm which line item(s) in Appendix A includes the majority of the expenses for XP-8121, and tell us the amount of the direct expenses related to XP-8121 for 2023 and the first quarter of 2024. • Revise your proposed disclosures to clarify whether the line item in Appendix A titled "Technology development" is the "emerging technology partnership business" that you listed as a factor for the increase in research and development expense on page 25 of your Form 10-Q for the period ended March 31, 2024. • As part of your future disclosures, revise to more clearly disclose the extent to which your emerging technology partnership business has had revenues and expenses in prior periods. • Further clarify the extent to which any of the amounts reported as Royalty, contract and other revenue related to this business. If so, quantify those amounts and clarify the extent to which the expenses related to these amounts are excluded from cost of goods sold but are included in research and development expenses. • Revise your Business section in future filings to better identify the activities of your technology partnership business and tie your discussions of these partnerships to your results of operations. Response to Comment No. 2: The Company respectfully acknowledges the Staff’s comment and would like to provide the following additional detail to supplement its responses set forth in the Company’s letter dated June 21, 2024 (the “original response”). In Appendix A of our original response, which is included here as Appendix A, XP-8121 is included in pipeline (also referred to as our product candidates). The direct costs for XP-8121 were $3.4 million in 2023 and $1.1 million in the first quarter of 2024. In future filings, we will disclose the impact of material external spend for XP-8121. In the description of research and development costs, we will disclose “We track external research and development costs by project, however, personnel related expenses related to research and development are not allocated by project”. In Appendix A, investment in our technology, XeriSol™ and XeriJect®, is included in Technology Development. In future filings, beginning with our Form 10-Q for the quarter ended June 30, 2024, we will define Technology Development as any investment in our proprietary technology platforms, XeriSol and XeriJect. As disclosed in our Form 10-K, we have proprietary formulation (or, as we will now describe them, technology) platforms, XeriSol and XeriJect, which we can use to develop our own product candidates or collaborate with other pharmaceutical and biotechnology companies to enhance the formulations of their proprietary products and candidates. Revenue from such research collaborations and partnerships is recorded in Royalty, contract and other revenue and the related expense is recorded in Cost of goods sold in the Consolidated Statements of Operations and Compressive Loss. In future filings, we will continue to disclose revenues and expenses for collaboration agreements to the extent they are material. Costs related to research collaborations and partnerships are generally personnel costs which have historically not been material to Cost of goods sold and, therefore, have not been disclosed. In future filings, beginning with our Form 10-Q for the quarter ended June 30, 2024, we will better clarify that collaboration and partnership revenue is included in Royalty, contract and other revenue and will disclose material amounts recorded in revenue and expenses from collaboration agreements. Sincerely, /s/ Steven M. Pieper Steven M. Pieper Chief Financial Officer cc: Beth P. Hecht, Chief Legal Officer and Corporate Secretary Joseph C. Theis, Goodwin Procter LLP Appendix A The following table summarizes our research and development expenses by type for the three and six months ended June 30, 2024 and 2023: Three Months Ended June 30, Change Six Months Ended June 30, Change 2024 2023 $ % 2024 2023 $ % Project specific expenses: Pipeline $ $ $ $ $ $ Technology development (1) Personnel related expenses Lab supplies and equipment depreciation Other Total $ $ $ $ $ $ (1) Technology Development represents any investment in our proprietary technology platforms, XeriSol and XeriJect.
2024-07-22 - UPLOAD - Xeris Biopharma Holdings, Inc. File: 001-40880
July 22, 2024
Steven Pieper
Chief Financial Officer
Xeris Biopharma Holdings, Inc.
1375 West Fulton Street, Suite 100
Chicago, IL 60607
Re:Xeris Biopharma Holdings, Inc.
Form 10-K for the year ended December 31, 2023
Form 10-Q for the quarterly period ended March 31, 2024
File No. 001-40880
Dear Steven Pieper:
We have reviewed your June 21, 2024 response to our comment letter and have the
following comments.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments. Unless we
note otherwise, any references to prior comments are to comments in our June 12, 2024 letter.
Form 10-Q for the quarterly period ended March 31, 2024
Management's Discussion Analysis of Financial Condition and Results of Operations, page 21
1.Your proposed disclosures in response to prior comment one say that "Cost of goods sold
as a percent of total revenue decreased by 3.0%, or 17.5% in 2023 compared to 20.5% in
2022. This decrease was primarily due to collaboration agreements, specifically upfront
and milestone achievements resulting in revenue." However, cost of goods sold as
percent of product revenue for 2023 was 18.7% compared to 20.7% for 2022. Revise
your proposed disclosure to explain the reasons for the decrease in cost of goods sold as a
percent of product revenue.
Please address the following regarding your response to prior comment two and your
proposed related disclosures:
You disclose on page 70 of your Form 10-K that the increase in research and
development expenses from 2022 to 2023 was driven by the expenses related to the •2.
July 22, 2024
Page 2
Phase 2 study for XP-8121. In your Form 10-Q for quarter ended March 31, 2024,
you disclose that the increase in research and development expenses was
"driven by strategic investments in our pipeline, notably XP-8121, and our emerging
technology partnership business as well as higher personnel costs." Please confirm
which line item(s) in Appendix A includes the majority of the expenses for XP-8121,
and tell us the amount of the direct expenses related to XP-8121 for 2023 and the first
quarter of 2024.
•Revise your proposed disclosures to clarify whether the line item in Appendix A titled
"Technology development" is the "emerging technology partnership business" that
you listed as a factor for the increase in research and development expense on page 25
of your Form 10-Q for the period ended March 31, 2024.
•As part of your future disclosures, revise to more clearly disclose the extent to which
your emerging technology partnership business has had revenues and expenses in
prior periods.
•Further clarify the extent to which any of the amounts reported as Royalty, contract
and other revenue related to this business. If so, quantify those amounts and clarify
the extent to which the expenses related to these amounts are excluded from cost of
goods sold but are included in research and development expenses.
•Revise your Business section in future filings to better identify the activities of
your technology partnership business and tie your discussions of these partnerships to
your results of operations.
Please contact Vanessa Robertson at 202-551-3649 or Kevin Vaughn at 202-551-3494 if
you have questions regarding comments on the financial statements and related matters.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2024-06-21 - CORRESP - Xeris Biopharma Holdings, Inc.
CORRESP 1 filename1.htm filename 1375 West Fulton Street, Suite 1300, Chicago, IL 60607 June 21, 2024 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, DC 20549 Attention: Vanessa Robertson Kevin Vaughn Re: Xeris Biopharma Holdings, Inc. Form 10-K for the year ended December 31, 2023 Form 10-Q for the quarterly period ended March 31, 2024 File No. 001-40880 To the addressees set forth above: On behalf of Xeris Biopharma Holdings, Inc. (the “Company”), set forth below is the Company’s response to the comment of the Staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) relating to the Company’s Form 10-K for the fiscal year ended December 31, 2023 (the “Form 10-K”), filed on March 6, 2024, and Form 10-Q for the quarterly period ended March 31, 2024 (the “Form 10-Q”), filed on May 9, 2024. For your convenience, each response below is prefaced by the exact text of the Staff’s corresponding comment. Form 10-K for the year ended December 31, 2023 Management's Discussion and Analysis of Financial Condition and Results of Operations, page 67 1. Revise your future filings to provide quantification of each of the individual factors you identified in your disclosure which led to the changes in each of your line items. As part of your response, address the following: • Revise to quantify the extent to which the changes in revenue from each specific product is from volume versus pricing. • Discuss the reasons for the changes in the amount of cost of goods sold as well as the changes in cost of goods sold as a percent of revenues. • Tell us and revise your future filings to quantify the one-time contract credit received in first quarter 2023 and explain the nature of this credit. Page 2 of 4 • You disclose on page 68 that "Manufacturing costs for Gvoke and Recorlev incurred prior to approval and initial commercialization were expensed as research and development expenses." Tell us and revise your future filings to quantify the impact of zero cost inventory for 2022 and 2023, as well as any future periods impacted. Response to Comment No. 1: The Company respectfully acknowledges the Staff’s comment and advises the Staff that in future filings, beginning with its Form 10-Q for the quarter ending June 30, 2024, the Company will revise its disclosure to include the Staff’s comments above. • For illustrative purposes, we have quantified in italics the extent to which the change in revenue from each specific product is from volume versus pricing for the year ended December 31, 2023. • Gvoke net revenue increased by $14.5 million or 27.6% for the year ended December 31, 2023 compared to the year ended December 31, 2022. Gvoke prescriptions grew approximately 48.9% in 2023 compared to the prior year. The growth in product demand (38%) was partially offset by a decrease in net pricing (10%). • Keveyis net revenue increased by $7.5 million or 15.1% for the year ended December 31, 2023 compared to the year ended December 31, 2022. This increase was driven by higher patient demand (10%) coupled with an increase in net pricing (5%). • For illustrative purposes, we have quantified in italics the change in cost of goods sold as well as changes in cost of goods sold as a percentage of revenue. • Cost of goods sold increased by $6.0 million or 26.6% for the year ended December 31, 2023 compared to the year ended December 31, 2022. This increase was mainly attributable to higher product sales ($8.6 million), partially offset by the product mix ($1.3 million) and a one-time contract credit in the first quarter of 2023 ($1.0 million). Cost of goods sold as a percent of total revenue decreased by 3.0%, or 17.5% in 2023 compared to 20.5% in 2022. This decrease was primarily due to collaboration agreements, specifically upfront and milestone achievements resulting in revenue. • As we publicly disclosed, Cost of goods sold was impacted by a one-time contract credit in the first quarter of 2023. This contract credit was for $1.0 million and related to the manufacturing of Gvoke. • Zero cost inventory was approximately $0.1 million in 2022, $0.2 million in 2023 and the total remaining amount will be $0.9 million in future years. As an example of future filings, we will add the following in italics. • Manufacturing costs for Gvoke and Recorlev incurred prior to approval and initial commercialization were expensed as research and development expenses. The amount of cost of goods sold with a zero value was $0.1 million in 2022, $0.2 million in 2023, and the total remaining amount will be $0.9 million in future years. Page 3 of 4 Form 10-Q for the quarterly period ended March 31, 2024 Management's Discussion and Analysis of Financial Condition and Results of Operations Results of Operations Research and development expenses, page 25 2. Please provide quantitative disclosures, to be included in future filings, for the type of research and development expenses incurred (i.e. by nature or type of expense) for each period presented, which should reconcile to total research and development expense. Revise to disclose the extent to which you track certain of your research and development costs on a project basis, and if so, disclose the amounts tracked for projects, where material. In addition, separately quantify the impact from each factor that led to the increase in research and development expense (e.g., investments in XP-8121, your emerging technology partnership business, as well as higher personnel costs). Response to Comment No. 2: The Company respectfully acknowledges the Staff’s comment and advises the Staff that in future filings, beginning with its Form 10-Q for the quarter ending June 30, 2024, the Company will revise its disclosure to disclose that the Company tracks certain research and development costs by project, however, the largest portion of research and development costs relate to employee costs which are not allocated by project. The Company supplementally advises the Staff that the remaining costs relate to external expenses for various projects, none of which are currently material on an individual basis. Therefore, the Company aggregates the remaining costs by nature of expenses. The Company advises the Staff that in future filings, beginning with its Form 10-Q for the quarter ending June 30, 2024, the Company will revise its disclosure to include the nature or type of expenses for each period. For illustrative purposes, the proposed disclosure is set forth in Appendix A using the three and six months ended June 30, 2024 and 2023. The Company anticipates that the proposed disclosure would be included in Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations under the caption “Results of Operations for the three and six months ended June 30, 2024 and 2023 - Research and Development”. As always, we appreciate the Staff’s review and comments. Please contact the undersigned at the contact information you have on file if you have any questions or comments. Sincerely, Steven M. Pieper Chief Financial Officer cc: Beth P. Hecht, Chief Legal Officer and Corporate Secretary Joseph C. Theis, Goodwin Procter LLP /s/ Steven M. Pieper Page 4 of 4 Appendix A The following table summarizes our research and development expenses by type for the three and six months ended June 30, 2024 and 2023:
2024-06-12 - UPLOAD - Xeris Biopharma Holdings, Inc. File: 001-40880
United States securities and exchange commission logo
June 12, 2024
Steven Pieper
Chief Financial Officer
Xeris Biopharma Holdings, Inc.
1375 West Fulton Street, Suite 100
Chicago, IL 60607
Re:Xeris Biopharma Holdings, Inc.
Form 10-K for the year ended December 31, 2023
Form 10-Q for the quarterly period ended March 31, 2024
File No. 001-40880
Dear Steven Pieper:
We have limited our review of your filings to the financial statements and related
disclosures and have the following comments.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Form 10-K for the year ended December 31, 2023
Management's Discussion and Analysis of Financial Condition and Results of Operations, page
67
1.Revise your future filings to provide quantification of each of the individual factors you
identified in your disclosure which led to the changes in each of your line items. As part
of your response, address the following:
•Revise to quantify the extent to which the changes in revenue from each specific
product is from volume versus pricing.
•Discuss the reasons for the changes in the amount of cost of goods sold as well as the
changes in cost of goods sold as a percent of revenues.
•Tell us and revise your future filings to quantify the one-time contract credit received
in first quarter 2023 and explain the nature of this credit.
•You disclose on page 68 that "Manufacturing costs for Gvoke and Recorlev incurred
prior to approval and initial commercialization were expensed as research and
development expenses." Tell us and revise your future filings to quantify the impact
FirstName LastNameSteven Pieper
Comapany NameXeris Biopharma Holdings, Inc.
June 12, 2024 Page 2
FirstName LastName
Steven Pieper
Xeris Biopharma Holdings, Inc.
June 12, 2024
Page 2
of zero cost inventory for 2022 and 2023, as well as any future periods impacted.
Form 10-Q for the quarterly period ended March 31, 2024
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations
Research and development expenses, page 25
2.Please provide quantitative disclosures, to be included in future filings, for the type of
research and development expenses incurred (i.e. by nature or type of expense) for each
period presented, which should reconcile to total research and development expense.
Revise to disclose the extent to which you track certain of your research and development
costs on a project basis, and if so, disclose the amounts tracked for projects, where
material. In addition, separately quantify the impact from each factor that led to the
increase in research and development expense (e.g., investments in XP-8121, your
emerging technology partnership business, as well as higher personnel costs).
In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
Please contact Vanessa Robertson at 202-551-3649 or Kevin Vaughn at 202-551-3494
with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-02-04 - CORRESP - Xeris Biopharma Holdings, Inc.
CORRESP 1 filename1.htm Document February 4, 2022 Via EDGAR Transmission United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Xeris Biopharma Holdings, Inc. Acceleration Request for Registration Statement on Form S-3 File No. 333-262404 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Xeris Biopharma Holdings, Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to February 7, 2022, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. If you have any questions regarding this request, please contact Joseph Theis of Goodwin Procter LLP at (617) 570-1928. Sincerely, XERIS BIOPHARMA HOLDINGS, INC. /s/ Paul R. Edick Paul R. Edick Chief Executive Officer cc: Paul R. Edick, Chief Executive Officer, Xeris Biopharma Holdings, Inc. Joseph Theis, Jr., Esq., Goodwin Procter LLP
2022-02-04 - CORRESP - Xeris Biopharma Holdings, Inc.
CORRESP 1 filename1.htm Document February 4, 2022 Via EDGAR Transmission United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Xeris Biopharma Holdings, Inc. Acceleration Request for Registration Statement on Form S-3 File No. 333-262403 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Xeris Biopharma Holdings, Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to February 7, 2022, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. If you have any questions regarding this request, please contact Joseph Theis of Goodwin Procter LLP at (617) 570-1928. Sincerely, XERIS BIOPHARMA HOLDINGS, INC. /s/ Paul R. Edick Paul R. Edick Chief Executive Officer cc: Paul R. Edick, Chief Executive Officer, Xeris Biopharma Holdings, Inc. Joseph Theis, Jr., Esq., Goodwin Procter LLP
2022-02-01 - UPLOAD - Xeris Biopharma Holdings, Inc.
United States securities and exchange commission logo
February 1, 2022
Paul Edick
Chairman and Chief Executive Officer
Xeris Biopharma Holdings, Inc.
180 N. LaSalle Street, Suite 1600
Chicago, Illinois 60601
Re:Xeris Biopharma Holdings, Inc.
Registration Statement on Form S-3
Filed January 28, 2022
File No. 333-262403
Dear Mr. Edick:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Michael Davis at 202-551-4385 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Joseph C. Theis, Jr., Esq.
2021-07-28 - CORRESP - Xeris Biopharma Holdings, Inc.
CORRESP 1 filename1.htm CORRESP July 28, 2021 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Laura Crotty Re: Xeris Biopharma Holdings, Inc. Registration Statement on Form S-4 (File No. 333-257642) Dear Ms. Crotty: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), Xeris Biopharma Holdings, Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to Thursday, July 29, 2021, at 4:00 p.m. Eastern Time, or as soon thereafter as practicable. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP by calling Joseph C. Theis, Jr. at (617) 570-1928. We also respectfully request that a copy of the written order from the Securities and Exchange Commission verifying the effective time and date of the Registration Statement be sent to our counsel, Goodwin Procter LLP, Attention: Joseph C. Theis, Jr., by email at JTheis@goodwinlaw.com. [Signature Page Follows] Sincerely, XERIS BIOPHARMA HOLDINGS, INC. /s/ Paul R. Edick Name: Paul R. Edick Title: Chief Executive Officer and Chairman cc: Beth Hecht, Xeris Pharmaceuticals, Inc. (via e-mail) Andrew Goodman, Goodwin Procter LLP (via e-mail) Stephanie A. Richards, Goodwin Procter LLP (via e-mail) [Signature Page – Acceleration Request]
2021-07-09 - UPLOAD - Xeris Biopharma Holdings, Inc.
United States securities and exchange commission logo
July 9, 2021
Beth Hecht, Esq.
General Counsel
Xeris Biopharma Holdings, Inc.
180 N. LaSalle Street, Suite 1600
Chicago, IL 60601
Re:Xeris Biopharma Holdings, Inc.
Registration Statement on Form S-4
Filed July 2, 2021
File No. 333-257642
Dear Ms. Hecht:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Laura Crotty at 202-551-7614 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Joseph C. Theis, Jr., Esq.