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): August 8, 2023
(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 August 8, 2023, 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 six months ended June 30, 2023. 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: August 8, 2023 | Xeris Biopharma Holdings, Inc. | |||||||||||||
| By: | /s/ Steven M. Pieper | |||||||||||||
| Name: Steven M. Pieper | ||||||||||||||
Title: Chief Financial Officer | ||||||||||||||
Exhibit 99.1
XERIS BIOPHARMA REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS
Achieved record revenue of $38.0M – a 14% increase from prior quarter, and a 50% increase from same period prior year
Ended Q2 with over $80M in cash, cash equivalents and short-term investments
Tightens full-year 2023 guidance: total net revenue of $145M-$165M; cash utilization of $57M-$67M; 2023 year-end cash balance of $55M-$65M
Remains on track to achieve cash flow breakeven by year-end 2023
Hosting conference call and webcast today at 8:30 a.m. ET
CHICAGO, IL; August 8, 2023 – Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the second quarter and six months ended June 30, 2023 and corporate highlights.
“We posted another record quarter of revenue due to the continued strong demand of all three products, as well as contributions from our partnerships,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “Our differentiated business model, exceptional year-to-date performance, and expectations for the remainder of the year gives us the confidence to tighten our 2023 guidance by raising the low end of the total revenue range to $145 to $165 million from $135 to $165 million; reducing cash utilization range to $57 to $67 million from $57 to $77 million; improving year-end cash range to $55 to $65 million. And, we expect to be at the cash flow breakeven point in the fourth quarter and continue being a self-sustaining enterprise.”
Second Quarter 2023 Highlights
| Three Months Ended June 30, | Change | |||||||||||||||||||
| 2023 | 2022 | $ | % | |||||||||||||||||
| Product revenue (in thousands): | ||||||||||||||||||||
| Gvoke | $ | 15,638 | $ | 11,479 | $ | 4,159 | 36.2 | |||||||||||||
| Keveyis | 14,088 | 12,812 | 1,276 | 10.0 | ||||||||||||||||
| Recorlev | 7,167 | 969 | 6,198 | nm | ||||||||||||||||
| Product revenue, net | 36,893 | 25,260 | 11,633 | 46.1 | ||||||||||||||||
| Royalty, contract and other revenue | 1,115 | 46 | 1,069 | nm | ||||||||||||||||
| Total revenue | $ | 38,008 | $ | 25,306 | $ | 12,702 | 50.2 | |||||||||||||
nm - not meaningful
Commercial Products
•Gvoke®: Second quarter 2023 net revenue was $15.6 million as compared to $11.5 million in the second quarter of 2022 – an increase of approximately 36%. Gvoke prescriptions topped 51,000 for the first time, growing 50% compared to the same period in 2022. Gvoke’s market share of the retail TRx glucagon market grew to approximately 29% at the end of July.
•Keveyis®: Second quarter net revenue was $14.1 million – an increase of 10% compared to the same period in 2022. The average number of patients on Keveyis increased approximately 11% from the same period in 2022.
•Recorlev®: Second quarter net revenue was $7.2 million – an increase of $6.2 million compared to the second quarter of 2022, the first full quarter since its launch. The average number of patients on Recorlev increased over 400% from the same period in 2022.
Pipeline Program
•XeriSol® levothyroxine (XP-8121): Xeris began dosing patients in its Phase 2 clinical study in the second quarter. The Company anticipates completing the study in the first half of 2024.
Year-to-Date 2023 Financial Results
| Six Months Ended June 30, | Change | |||||||||||||||||||
| 2023 | 2022 | $ | % | |||||||||||||||||
| Product revenue (in thousands): | ||||||||||||||||||||
| Gvoke | $ | 30,671 | $ | 23,932 | $ | 6,739 | 28.2 | |||||||||||||
| Keveyis | 26,843 | 22,136 | 4,707 | 21.3 | ||||||||||||||||
| Recorlev | 11,644 | 1,102 | 10,542 | nm | ||||||||||||||||
| Product revenue, net | 69,158 | 47,170 | 21,988 | 46.6 | ||||||||||||||||
| Royalty, contract and other revenue | 2,046 | 209 | 1,837 | nm | ||||||||||||||||
| Total revenue | $ | 71,204 | $ | 47,379 | $ | 23,825 | 50.3 | |||||||||||||
nm - not meaningful
•Gvoke®: Net revenue was $30.7 million for the six months ended June 30, 2023, a 28% increase compared to prior year. Gvoke prescriptions for the first half of 2023 were over 97,000 TRx’s, growing 50% compared to the same period in 2022. The growth in product demand was partially offset by a decrease in net pricing.
•Keveyis®: Net revenue was $26.8 million for the six months ended June 30, 2023, a 21% increase from last year. This increase was driven by a 9% increase in sales volume and an increase in net pricing.
•Recorlev®: Net revenue was $11.6 million for the six months ended June 30,2023, a $10.5 million increase from last year, driven primarily by increases in the number of patients on therapy.
Cost of goods sold increased by $2.7 million or 57.1% for the three months ended June 30, 2023 compared to the same period ended June 30, 2022. The increase was attributable to higher product sales and product mix. Cost of goods sold increased by $1.8 million or 16.2% for the six months ended June 30, 2023 compared to the same period ended June 30, 2022. The increase was attributable to higher product sales and product mix, partially offset by a one-time contract credit in the first quarter of 2023.
Research and development expenses increased by $2.4 million or 63.7% and $1.0 million or 9.6% for the three and six months ended June 30, 2023, respectively, compared to the same periods ended June 30, 2022. The increases in both periods were due to higher spending on the Open-label Treatment in Cushing’s Syndrome (OPTICS) study for Recorlev and higher product development costs.
Selling, general and administrative expenses increased by $4.7 million or 14.1% and $2.3 million or 3.4% for the three and six months ended 2023, respectively, compared to the same periods ended June 30, 2022, due to higher personnel costs, marketing expenses and rent expenses related to the new lease commenced in April 2023.
Net Loss for the three months ended June 30, 2023, was $19.8 million, or $0.14 per share, and a net loss of $36.7 million, or $0.27 per share, for the six months ended June 30, 2023.
Cash, cash equivalents, and short-term investments at June 30, 2023 was $80.7 million compared to $122.0 million at December 31, 2022. Total shares outstanding at July 31, 2023 was 138,065,993.
Conference Call and Webcast Details
Xeris will host a conference call and webcast today, Tuesday, August 8, 2023, at 8:30 a.m. Eastern Time. To pre-register for the conference call please use this link: https://www.netroadshow.com/events/login?show=73c6056b&confId=53289 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 Tuesday, August 22, 2023 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: 729515.
In addition, a live audio of the conference call will be available as a webcast. 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/901721849
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®, the first and only FDA-approved 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 Twitter, LinkedIn, or Instagram.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc. including statements regarding the financial outlook for 2023, including projections regarding year-end 2023 cash estimates and total revenue, the Company’s expectations regarding its cash flow breakeven timeline, the market and therapeutic potential of its products and product candidates, continued growth of Gvoke, Keveyis and Recorlev, continued use of Xeris’ formulation sciences in development and partnered programs, potentially new partnerships and collaborations, expectations regarding clinical data or results from planned clinical trials, the timing of clinical trials, including advancement of its levothyroxine clinical program and a related Phase 2 study results in the first half of 2024, the potential utility of its formulation platforms, cash management, becoming a self-sustaining enterprise, and other statements containing the words “will,” “would,” “continue,” “expect,” “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 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 information about potential impacts of COVID-19, 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 Annual Report on Form 10-K 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 believed to be 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 June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
| Product revenue, net | $ | 36,893 | $ | 25,260 | $ | 69,158 | $ | 47,170 | |||||||||||||||
| Royalty, contract and other revenue | 1,115 | 46 | 2,046 | 209 | |||||||||||||||||||
| Total revenue | 38,008 | 25,306 | 71,204 | 47,379 | |||||||||||||||||||
| Costs and expenses: | |||||||||||||||||||||||
| Cost of goods sold | 7,555 | 4,810 | 12,874 | 11,083 | |||||||||||||||||||
| Research and development | 6,087 | 3,718 | 10,925 | 9,968 | |||||||||||||||||||
| Selling, general and administrative | 37,635 | 32,984 | 71,240 | 68,897 | |||||||||||||||||||
| Amortization of intangible assets | 2,710 | 2,710 | 5,421 | 5,421 | |||||||||||||||||||
| Total costs and expenses | 53,987 | 44,222 | 100,460 | 95,369 | |||||||||||||||||||
| Loss from operations | (15,979) | (18,916) | (29,256) | (47,990) | |||||||||||||||||||
| Other expense | (4,538) | (7,608) | (8,095) | (12,656) | |||||||||||||||||||
| Net loss before benefit from income taxes | (20,517) | (26,524) | (37,351) | (60,646) | |||||||||||||||||||
| Benefit from income taxes | 675 | 339 | 675 | 747 | |||||||||||||||||||
| Net loss | $ | (19,842) | $ | (26,185) | $ | (36,676) | $ | (59,899) | |||||||||||||||
| Net loss per common share - basic and diluted | $ | (0.14) | $ | (0.19) | $ | (0.27) | $ | (0.44) | |||||||||||||||
| Weighted average common shares outstanding - basic and diluted | 137,338,071 | 135,529,968 | 137,250,465 | 135,282,749 | |||||||||||||||||||
XERIS BIOPHARMA HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
| June 30, 2023 | December 31, 2022 | ||||||||||
| (unaudited) | |||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 46,170 | $ | 121,966 | |||||||
| Short-term investments | 34,498 | — | |||||||||
| Trade accounts receivable, net | 30,225 | 30,830 | |||||||||
| Inventory | 36,538 | 24,735 | |||||||||
| Prepaid expenses and other current assets | 8,310 | 9,287 | |||||||||
| Total current assets | 155,741 | 186,818 | |||||||||
| Property and equipment, net | 6,552 | 5,516 | |||||||||
| Intangible assets, net | 115,186 | 120,607 | |||||||||
| Goodwill | 22,859 | 22,859 | |||||||||
| Operating lease right-of-use assets | 23,632 | 3,992 | |||||||||
| Other assets | 4,808 | 4,730 | |||||||||
| Total assets | $ | 328,778 | $ | 344,522 | |||||||
| Liabilities and Stockholders’ Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 11,621 | $ | 4,606 | |||||||
| Current operating lease liabilities | 1,935 | 1,580 | |||||||||
| Other accrued liabilities | 19,413 | 36,786 | |||||||||
| Accrued trade discounts and rebates | 17,034 | 16,818 | |||||||||
| Accrued returns reserve | 11,320 | 11,173 | |||||||||
| Current portion of contingent value rights | 16,637 | — | |||||||||
| Other current liabilities | 1,718 | 2,658 | |||||||||
| Total current liabilities | 79,678 | 73,621 | |||||||||
| Long-term debt, net of unamortized debt issuance costs | 188,182 | 187,075 | |||||||||
| Non-current contingent value rights | 6,911 | 25,688 | |||||||||
| Non-current operating lease liabilities | 34,871 | 9,402 | |||||||||
| Deferred tax liabilities | 2,843 | 3,518 | |||||||||
| Other liabilities | 2,652 | 31 | |||||||||
| Total liabilities | 315,137 | 299,335 | |||||||||
| Total stockholders’ equity | 13,641 | 45,187 | |||||||||
| Total liabilities and stockholders’ equity | $ | 328,778 | $ | 344,522 | |||||||