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 10, 2022
(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 10, 2022, 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, 2022. 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 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.
| 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 10, 2022 | 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 FINANCIAL RESULTS AND UPCOMING EVENTS
Achieved record net product revenue of $25.3M – a 15% increase from Q1 ’22, and a 34% increase from same period prior year on a pro forma basis
Ended Q2 with $111.6M in cash, cash equivalents and short-term investments
Reaffirms full-year total net product revenue of $105M-$120M; $50M in synergies by year-end, 2022 year-end cash balance of $90M-$110M, and cash flow breakeven by year-end 2023
Hosting conference call and webcast today at 8:30 a.m. ET
CHICAGO, IL; August 10, 2022 – 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, 2022 and upcoming events.
“We continue to execute our growth strategy and are pleased to have posted record net revenue in the second quarter. Demand for Gvoke HypoPen remains strong and its market share continues to outpace the overall glucagon market; Keveyis reported its best quarter to date; and newly launched Recorlev is off to a great start,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “We continue to drive education and awareness of all three products and remain confident in the long-term growth opportunity of each. Our strong performance year-to-date and expectations for the remainder of the year gives us confidence that we will achieve our guidance of net product revenue to $105 million to $120 million for the full year 2022, year-end cash balance of $90 million-$110 million and cash flow breakeven by year-end 2023.”
Second Quarter Highlights and Upcoming Events
Commercial Products
•Gvoke®: Second quarter 2022 net revenue was $11.5 million as compared to $8.8 million in the second quarter of 2021 – an increase of approximately 30%. Gvoke prescriptions topped 34,000 for the first time, growing more than 60% compared to the same period in 2021. Gvoke’s market share of the retail TRx glucagon market grew to approximately 22% at the end of July.
•Keveyis®: Second quarter net revenue was $12.8 million – an increase of 28% compared to the same period in 2021 on a pro forma basis. The number of patients on Keveyis increased 5% from the same period in 2021.
•Recorlev®: Second quarter net revenue was $1.0 million. Xeris launched Recorlev in February 2022 and is experiencing a steady increase of physicians’ referrals and patients’ starts.
| Three Months Ended June 30, | Change | |||||||||||||||||||
| 2022 | 2021 | $ | % | |||||||||||||||||
| Product revenue (in thousands): | ||||||||||||||||||||
| Gvoke | $ | 11,479 | $ | 8,835 | $ | 2,644 | 30% | |||||||||||||
| Keveyis | 12,812 | — | 12,812 | nm | ||||||||||||||||
| Recorlev | 969 | — | 969 | nm | ||||||||||||||||
| Product revenue, net | 25,260 | 8,835 | 16,425 | nm | ||||||||||||||||
| Royalty, contract and other revenue | 46 | 71 | (25) | -35% | ||||||||||||||||
| Total revenue | $ | 25,306 | $ | 8,906 | $ | 16,400 | nm | |||||||||||||
Commercial Partner Update
•Ogluo®: On August 4, 2022, Arecor Therapeutics completed the acquisition of Tetris Pharma, Xeris’ commercial partner for Ogluo in the UK and EU. Tetris Pharma is now a subsidiary of Arecor Therapeutics and continues to commercialize Ogluo in the UK and EU.
Upcoming Events
•XeriSol® levothyroxine (XP-8121): The third and final cohort was successfully dosed during the second quarter. The Company anticipates reporting topline data from a range of doses and dose proportionality early in the fourth quarter.
•Xeris will participate at the H. C. Wainwright’s 24th Annual Global Investment Conference, September 12-14, in New York City.
Second Quarter and Year-to-Date 2022 Financial Results
Gvoke®: Net revenue was $23.9 million for the six months ended June 30, 2022, a 42% increase compared to prior year. Gvoke prescriptions for YTD 2022 were over 65,000 TRx’s, growing more than 73% compared to the same period in 2021. The growth in product demand was partially offset by a decrease in net pricing.
Keveyis®: Net revenue was $22.1 million for the six months ended June 30, 2022, a 20% increase from last year on a pro forma basis. This increase was driven by an 11% increase in sales volume and an increase in net pricing.
Recorlev®: Net revenue was $1.1 million since its launch in February 2022.
| Six Months Ended June 30, | Change | |||||||||||||||||||
| 2022 | 2021 | $ | % | |||||||||||||||||
| Product revenue (in thousands): | ||||||||||||||||||||
| Gvoke | $ | 23,932 | $ | 16,886 | $ | 7,046 | 42% | |||||||||||||
| Keveyis | 22,136 | — | 22,136 | nm | ||||||||||||||||
| Recorlev | 1,102 | — | 1,102 | nm | ||||||||||||||||
| Product revenue, net | 47,170 | 16,886 | 30,284 | nm | ||||||||||||||||
| Royalty, contract and other revenue | 209 | 215 | (6) | -3% | ||||||||||||||||
| Total revenue | $ | 47,379 | $ | 17,101 | $ | 30,278 | nm | |||||||||||||
Cost of goods sold were $4.8 million and $11.1 million for the three and six months ended June 30, 2022, respectively, a $1.4 million and a $5.9 million increase compared to the same periods last year. The increases were primarily attributable to increases in sales as well as product mix and increased costs.
Research and development expenses decreased $1.7 million or 30.9% and increased $0.6 million or 5.9% for the three and six months ended June 30, 2022, respectively, compared to the same periods last year. The quarter-to-date decrease was primarily driven by reduced spend on clinical and product development. The year-to-date increase was primarily driven by higher personnel related costs, offset by lower product development costs.
Selling, general and administrative expenses increased $7.1 million or 27.2% and $23.9 million or 53.1% for the three and six months ended June 30, 2022, respectively, compared to the same periods last year. The quarter-to-date increase was mainly attributable to a $9.7 million of increased personnel-related costs due to the build out of our sales force to support our three commercial products. These were offset by $3.8 million decreased expenses related to the acquisition of Strongbridge. The year-to-date increase was mainly attributable to a $19.6 million increase in personnel-related costs due to the buildout of the sales force to support our three commercial products. We also had a $2.5 million increase in marketing expenses to primarily support the launch of Recorlev.
Net Loss for the three months ended June 30, 2022, was $26.2 million, or $0.19 per share, and a net loss of $59.9 million, or $0.44 per share, for the six months ended June 30, 2022.
Cash, cash equivalents, and short-term investments at June 30, 2022 was $111.6 million compared to $102.4 million at December 31, 2021. Total shares outstanding at July 31, 2022 was 135,957,280.
Conference Call and Webcast Details
Xeris will host a conference call and webcast today, Wednesday, August 10, 2022, at 8:30 a.m. Eastern Time. To pre-register for the conference call please use this link: https://ige.netroadshow.com/registration/q4inc/11152/xeris-biopharma-second-quarter-2022-financial-results-call/. 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 Wednesday, August 24, 2022, 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: 562978. 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.
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 the full-year 2022, including projections regarding year-end 2022 cash estimates, the Company’s expectations regarding its cash flow breakeven projection, estimates and projections about the potential synergies in fiscal year 2022 resulting from the Strongbridge Biopharma acquisition, the market and therapeutic potential of its products and product candidates, expectations regarding clinical data or results from planned clinical trials, the timing of clinical trials, the timing or likelihood of regulatory approval and commercialization of its product candidates, the timing or likelihood of expansion into additional markets, the potential utility of its formulation platforms and other statements containing the words “will,” “would,” “continue,” 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, 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 factors described in the context of such forward-looking statements in this communication 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. Although it is believed that the expectations reflected in such forward-looking statements are reasonable, no assurance can be given that such expectations will prove to have been correct and persons reading this communication are therefore cautioned not to place undue reliance on these forward-looking statements which speak only as at the date of this communication. Additional information about economic, competitive, governmental, technological, and other factors that may affect Xeris is set forth in the "Risk Factors" section of the 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. Any forward-looking statements in this communication are based upon information available to Xeris, as of the date of this communication and, while believed to be true when made, may ultimately prove to be incorrect. Subject to any obligations under applicable law, Xeris does 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. All subsequent written and oral forward-looking statements attributable to Xeris or any person acting on behalf of any of them are expressly qualified in their entirety by this paragraph.
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, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Product revenue, net | $ | 25,260 | $ | 8,835 | $ | 47,170 | $ | 16,886 | |||||||||||||||
| Royalty, contract and other revenue | 46 | 71 | 209 | 215 | |||||||||||||||||||
| Total revenue | 25,306 | 8,906 | 47,379 | 17,101 | |||||||||||||||||||
| Costs and expenses: | |||||||||||||||||||||||
| Cost of goods sold, excluding amortization of intangible assets | 4,810 | 3,383 | 11,083 | 5,209 | |||||||||||||||||||
| Research and development | 3,718 | 5,383 | 9,968 | 9,415 | |||||||||||||||||||
| Selling, general and administrative | 32,984 | 25,927 | 68,897 | 45,004 | |||||||||||||||||||
| Amortization of intangible assets | 2,710 | — | 5,421 | — | |||||||||||||||||||
| Total costs and expenses | 44,222 | 34,693 | 95,369 | 59,628 | |||||||||||||||||||
| Loss from operations | (18,916) | (25,787) | (47,990) | (42,527) | |||||||||||||||||||
| Other expense | (7,608) | (1,728) | (12,656) | (3,399) | |||||||||||||||||||
| Net loss before benefit from income taxes | (26,524) | (27,515) | (60,646) | (45,926) | |||||||||||||||||||
| Benefit from income taxes | 339 | — | 747 | — | |||||||||||||||||||
| Net loss | $ | (26,185) | $ | (27,515) | $ | (59,899) | $ | (45,926) | |||||||||||||||
| Net loss per common share - basic and diluted | $ | (0.19) | $ | (0.41) | $ | (0.44) | $ | (0.72) | |||||||||||||||
| Weighted average common shares outstanding - basic and diluted | 135,529,968 | 66,367,125 | 135,282,749 | 63,820,321 | |||||||||||||||||||
XERIS BIOPHARMA HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
| June 30, 2022 | December 31, 2021 | ||||||||||
| (unaudited) | |||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 95,340 | $ | 67,271 | |||||||
| Short-term investments | 16,213 | 35,162 | |||||||||
| Trade accounts receivable, net | 25,756 | 17,456 | |||||||||
| Inventory | 17,887 | 18,118 | |||||||||
| Prepaid expenses and other current assets | 6,010 | 4,589 | |||||||||
| Total current assets | 161,206 | 142,596 | |||||||||
| Property and equipment, net | 6,170 | 6,627 | |||||||||
| Goodwill | 22,859 | 22,859 | |||||||||
| Intangible assets, net | 126,029 | 131,450 | |||||||||
| Other assets | 2,352 | 829 | |||||||||
| Total assets | $ | 318,616 | $ | 304,361 | |||||||
| Liabilities and Stockholders’ Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | 6,631 | 8,924 | |||||||||
| Other accrued liabilities | 36,945 | 49,088 | |||||||||
| Accrued trade discounts and rebates | 14,843 | 15,041 | |||||||||
| Accrued returns reserve | 5,210 | 4,000 | |||||||||
| Other current liabilities | 916 | 1,987 | |||||||||
| Total current liabilities | 64,545 | 79,040 | |||||||||
| Long-term debt, net of unamortized debt issuance costs | 138,068 | 88,067 | |||||||||
| Contingent value rights | 30,218 | 22,531 | |||||||||
| Supply agreement liability, less current portion | — | 5,991 | |||||||||
| Deferred rent | 6,799 | 6,883 | |||||||||
| Deferred tax liabilities | 4,195 | 4,942 | |||||||||
| Other liabilities | 848 | 1,676 | |||||||||
| Total liabilities | 244,673 | 209,130 | |||||||||
| Total stockholders’ equity | 73,943 | 95,231 | |||||||||
| Total liabilities and stockholders’ equity | $ | 318,616 | $ | 304,361 | |||||||