UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 8, 2024
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | |||||||||||||||
(Address of principal executive offices, including zip code)
(844 ) 445-5704
(Registrant's telephone number, including area code)
(Not applicable)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: | ||||||||||||||||||||||||||
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | ||||||||||||||||||||||||||
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | ||||||||||||||||||||||||||
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | ||||||||||||||||||||||||||
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | ||||||||||||||||||||||||||
| Securities registered pursuant to Section 12(b) of the Act: | ||||||||||||||||||||||||||
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). | ||||||||||||||||||||||||||
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 8, 2024, Xeris Biopharma Holdings, Inc. (the "Company") issued a press release containing information about the Company’s results of operations and business highlights for the three and nine months ended September 30, 2024. A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description | |||||||
| 99.1 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: November 8, 2024 | Xeris Biopharma Holdings, Inc. | |||||||||||||
| By: | /s/ Steven M. Pieper | |||||||||||||
| Name: Steven M. Pieper | ||||||||||||||
Title: Chief Financial Officer | ||||||||||||||
Exhibit 99.1
XERIS BIOPHARMA REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS
Achieved record total revenue of $54.3M including record product revenue of $52.9M
Product revenue increased 27% versus prior year and 14% over the prior quarter
Ended Q3 with $69.4M in cash, cash equivalents and short-term investments
Raises full-year guidance of total net revenue to $198M-$202M and
tightens year-end cash to $68M-$72M
Hosting conference call and webcast today at 8:30 a.m. ET
CHICAGO, IL; November 8, 2024 – 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 financial results for the third quarter and nine months ended September 30, 2024.
“We are proud to report our record-breaking quarter with total revenue of our $54 million led by strong demand of Recorlev® and Gvoke®. Our product revenue growth of 27% marks the 12th consecutive quarter of over 20% growth," said John Shannon, CEO of Xeris. "We have made investments in areas that drive growth, notably Recorlev®, and we are seeing the benefits of those investments. Given our exceptional year-to-date performance, we are raising our revenue guidance to $198-$202 million from the previous $190-$200 million. Looking ahead, our focus remains on continuing to drive greater than 20% product revenue growth and advancing our robust pipeline - namely our Phase 3 ready, XP-8121."
“While delivering exceptional revenue growth, we held our total operating expenses relatively flat to last quarter when you exclude non-routine charges,” said Steven Pieper, CFO of Xeris. “We will continue to drive robust revenue growth, maintain our strong margin profile, and diligently manage expenses, which gives us confidence that the business is financially sound and does not require any dilutive financing to fund our growth.”
Third Quarter 2024 Highlights
| Three Months Ended September 30, | Change | |||||||||||||||||||
| 2024 | 2023 | $ | % | |||||||||||||||||
| Product revenue (in thousands): | ||||||||||||||||||||
| Gvoke | $ | 22,942 | $ | 17,735 | $ | 5,207 | 29.4 | |||||||||||||
| Recorlev | 17,726 | 8,097 | 9,629 | 118.9 | ||||||||||||||||
| Keveyis | 12,193 | 15,865 | (3,672) | (23.1) | ||||||||||||||||
| Product revenue, net | 52,861 | 41,697 | 11,164 | 26.8 | ||||||||||||||||
| Royalty, contract and other revenue | 1,407 | 6,623 | (5,216) | (78.8) | ||||||||||||||||
| Total revenue | $ | 54,268 | $ | 48,320 | $ | 5,948 | 12.3 | |||||||||||||
Commercial Products
•Gvoke®: Third quarter net revenue was $22.9 million as compared to $17.7 million in the third quarter of 2023 – an increase of approximately 29%. Gvoke prescriptions topped 70,000 for the first time, growing 20% compared to the same period in 2023. Gvoke’s share of the retail TRx glucagon market grew to approximately 36% at the end of October.
•Recorlev®: Third quarter net revenue was $17.7 million – an increase of 119% compared to the third quarter of 2023. This growth was driven by the average number of patients on Recorlev increasing 125% from the same period in 2023. On a sequential basis, Recorlev net revenue increased 33% versus prior quarter.
•Keveyis®: Third quarter net revenue was $12.2 million as compared to $15.9 million in the third quarter of 2023 - a decrease of approximately 23% driven by a reduction in patients on therapy. On a sequential basis, net revenue decreased 7% due to pharmacy reimbursement changes.
Year-to-Date 2024 Financial Results
| Nine Months Ended September 30, | Change | |||||||||||||||||||
| 2024 | 2023 | $ | % | |||||||||||||||||
| Product revenue (in thousands): | ||||||||||||||||||||
| Gvoke | $ | 59,567 | $ | 48,406 | $ | 11,161 | 23.1 | |||||||||||||
| Recorlev | 41,663 | 19,741 | 21,922 | 111.0 | ||||||||||||||||
| Keveyis | 38,406 | 42,708 | (4,302) | (10.1) | ||||||||||||||||
| Product revenue, net | 139,636 | 110,855 | 28,781 | 26.0 | ||||||||||||||||
| Royalty, contract and other revenue | 3,335 | 8,669 | (5,334) | (61.5) | ||||||||||||||||
| Total revenue | $ | 142,971 | $ | 119,524 | $ | 23,447 | 19.6 | |||||||||||||
•Gvoke®: Net revenue was $59.6 million for the nine months ended September 30, 2024, a 23% increase compared to prior year. Gvoke prescriptions for the nine months were approximately 194,000, growing approximately 24% compared to the same period in 2023.
•Recorlev®: Net revenue was $41.7 million for the nine months ended September 30, 2024, a 111% increase from last year, driven by an increase in the number of patients on therapy.
•Keveyis®: Net revenue was $38.4 million for the nine months ended September 30, 2024, a 10% decrease from last year due to a reduction in patients on therapy.
Cost of goods sold increased $5.4 million and $6.3 million for the three and nine months ended September 30, 2024 compared to the same periods ended September 30, 2023. These increases were primarily due to a $3.6 million write-off of Gvoke components resulting from manufacturing process changes required to support ongoing Gvoke capacity expansion efforts.
Research and development (R&D) expenses increased slightly by $0.9 million and $3.5 million for the three and nine months ended September 30, 2024 compared to the same periods ended September 30, 2023. R&D increased primarily due to higher spending for pipeline and personnel related expenses.
Selling, general and administrative (SG&A) expenses increased by $7.7 million and $14.8 million for the three and nine months ended September 30, 2024 compared to the same periods ended September 30, 2023, primarily due to the costs associated with the CEO succession plan and related restructuring ($6.1 million) as well as higher costs related to the Recorlev expansions, partially offset by lower external spending.
Net Loss for the three months ended September 30, 2024, was $15.7 million, or ($0.11) per share, and $49.7 million, or ($0.34) per share, for the nine months ended September 30, 2024. Excluding the impact of the CEO succession plan and related restructuring costs of $6.1 million, earnings per share was ($0.06) for the quarter or ($0.30) for the year-to-date.
Cash, cash equivalents, and short-term investments at September 30, 2024 was $69.4 million, compared to $72.5 million at December 31, 2023. Total shares outstanding at October 31, 2024 was 149,081,461.
Conference Call and Webcast Details
Xeris will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss the Company’s financial and operational results.
To pre-register for the call, please go to the following link: https://www.netroadshow.com/events/login?show=6c5018a9&confId=72180 After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering a minimum of ten minutes prior to the start of the call. Following the conference call, a replay will be available until Friday, November 22, 2024 at US:1 929 458 6194, US Toll Free: 1 866 813 9403, UK: 0204 525 0658, Canada: 1 226 828 7578, or all other locations: +44 204 525 0658 Access Code: 906920
To join the webcast, please visit “Events” on investor relations page of the Company’s website at www.xerispharma.com or use this link: https://events.q4inc.com/attendee/232807470
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, a proven therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol® and XeriJect®, supporting long-term product development and commercial success.
Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow us on X, LinkedIn, or Instagram.
Forward-Looking Statements
Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc. including statements regarding the financial outlook for 2024, projections regarding year-end 2024 cash estimates and total revenue, the potential for growth of revenue, the market and therapeutic potential of its products and product candidates, the potential utility of its formulation platforms, the advancement of its pipeline (including XP-8121), and other statements containing the words “will,” “would,” “continue,” “expect,” “should,” “anticipate” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris’ experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, geopolitical factors and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The various factors that could cause Xeris’ actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements, include, but are not limited to, its financial position and need for financing, including to fund its product development programs or commercialization efforts, whether its products will achieve and maintain market acceptance in a competitive business environment, its reliance on third-party suppliers, including single-source suppliers, its reliance on third parties to conduct clinical trials, the ability of its product candidates to compete successfully with existing and new drugs, and its and collaborators’ ability to protect its intellectual property and proprietary technology. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional risks and information about potential impacts of financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect Xeris can be found in Xeris’ filings, including its most recently filed Quarterly Report on Form 10-Q filed with the Securities and Exchange
Commission, the contents of which are not incorporated by reference into, nor do they form part of, this communication. Forward-looking statements in this communication are based on information available to us, as of the date of this communication and, while we believe our assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, we do not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations.
Investor Contact
Allison Wey
Senior Vice President, Investor Relations and Corporate Communications
awey@xerispharma.com
312-736-1237
XERIS BIOPHARMA HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||
| Product revenue, net | $ | 52,861 | $ | 41,697 | $ | 139,636 | $ | 110,855 | |||||||||||||||
| Royalty, contract and other revenue | 1,407 | 6,623 | 3,335 | 8,669 | |||||||||||||||||||
| Total revenue | 54,268 | 48,320 | 142,971 | 119,524 | |||||||||||||||||||
| Costs and expenses: | |||||||||||||||||||||||
| Cost of goods sold | 13,593 | 8,201 | 27,354 | 21,075 | |||||||||||||||||||
| Research and development | 5,888 | 5,034 | 19,468 | 15,959 | |||||||||||||||||||
| Selling, general and administrative | 44,969 | 37,287 | 123,342 | 108,527 | |||||||||||||||||||
| Amortization of intangible assets | 2,711 | 2,711 | 8,132 | 8,132 | |||||||||||||||||||
| Total costs and expenses | 67,161 | 53,233 | 178,296 | 153,693 | |||||||||||||||||||
| Loss from operations | (12,893) | (4,913) | (35,325) | (34,169) | |||||||||||||||||||
| Other expense | (6,169) | (7,614) | (16,666) | (15,709) | |||||||||||||||||||
| Net loss before benefit from income taxes | (19,062) | (12,527) | (51,991) | (49,878) | |||||||||||||||||||
| Income tax benefit | 3,324 | 338 | 2,268 | 1,013 | |||||||||||||||||||
| Net loss | $ | (15,738) | $ | (12,189) | $ | (49,723) | $ | (48,865) | |||||||||||||||
| Net loss per common share - basic and diluted | $ | (0.11) | $ | (0.09) | $ | (0.34) | $ | (0.36) | |||||||||||||||
| Weighted average common shares outstanding - basic and diluted | 148,993,823 | 138,059,781 | 145,962,198 | 137,523,202 | |||||||||||||||||||
XERIS BIOPHARMA HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
| September 30, 2024 | December 31, 2023 | ||||||||||
| (unaudited) | |||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 59,232 | $ | 67,449 | |||||||
| Short-term investments | 10,170 | 5,002 | |||||||||
| Trade accounts receivable, net | 41,138 | 39,197 | |||||||||
| Inventory | 45,119 | 38,838 | |||||||||
| Prepaid expenses and other current assets | 7,140 | 5,778 | |||||||||
| Total current assets | 162,799 | 156,264 | |||||||||
| Property and equipment, net | 5,613 | 5,971 | |||||||||
| Intangible assets, net | 101,632 | 109,764 | |||||||||
| Goodwill | 22,859 | 22,859 | |||||||||
| Operating lease right-of-use assets | 22,758 | 23,204 | |||||||||
| Other assets | 5,443 | 4,540 | |||||||||
| Total assets | $ | 321,104 | $ | 322,602 | |||||||
| Liabilities and Stockholders’ Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 7,451 | $ | 11,565 | |||||||
| Current portion of long-term debt | 15,057 | — | |||||||||
| Current operating lease liabilities | 6,042 | 3,495 | |||||||||
| Other accrued liabilities | 23,543 | 23,510 | |||||||||
| Accrued trade discounts and rebates | 20,519 | 22,149 | |||||||||
| Accrued returns reserve | 17,723 | 14,198 | |||||||||
| Current portion of contingent value rights | — | 19,109 | |||||||||
| Other current liabilities | 678 | 1,167 | |||||||||
| Total current liabilities | 91,013 | 95,193 | |||||||||
| Long-term debt, net of unamortized debt issuance costs | 216,227 | 190,932 | |||||||||
| Non-current contingent value rights | — | 1,379 | |||||||||
| Non-current operating lease liabilities | 33,639 | 34,764 | |||||||||
| Deferred tax liabilities | — | 2,268 | |||||||||
| Other liabilities | 8,548 | 4,848 | |||||||||
| Total liabilities | 349,427 | 329,384 | |||||||||
| Total stockholders’ equity (deficit) | (28,323) | (6,782) | |||||||||
| Total liabilities and stockholders’ equity (deficit) | $ | 321,104 | $ | 322,602 | |||||||