Xeris Biopharma Reports First Quarter 2024 Financial Results and Recent Events
Xeris Biopharma reported a Q1 2024 total revenue of $40.6M, up 22% from Q1 2023, with full-year 2024 revenue guidance set at $175M-$200M. They ended Q1 with $87.4M in cash, closed licensing agreements for XeriJect® and XeriSol™ formulations, and announced a partnership with Beta Bionics. The company highlighted growth in product revenue, net revenue, and new technology partnerships.
Xeris Biopharma posted a strong Q1 2024 total revenue of $40.6M, reflecting a 22% increase from Q1 2023.
The company's total product revenue grew 25% in Q1, driven by impressive growth in Recorlev sales, Keveyis' market resilience, and Gvoke's increasing market share.
Xeris tightened its 2024 total revenue guidance to $175M-$200M, showcasing confidence in their business projections.
The partnership with Beta Bionics for the development of a new XeriSol™ formulation of glucagon for bi-hormonal pumps and pump systems is a significant positive event for Xeris Biopharma.
The company successfully completed the Phase 2 clinical study for XeriSol™ levothyroxine (XP-8121) and announced upcoming data availability by mid-2024.
Xeris Biopharma reported a net loss of $19.0 million or $0.14 per share for Q1 2024, indicating financial challenges.
The increase in cost of goods sold, research and development expenses, and selling, general, and administrative expenses may impact the company's profitability and financial performance.
Although Xeris' revenue showed growth, they faced a $3 million negative impact on Gvoke revenue due to the Change Healthcare cyberattack, signaling potential vulnerability to external factors.
Insights
Q1 2024 Total Revenue of
Tightening full-year 2024 total revenue guidance to
Ended Q1 with
Entered into a worldwide license agreement for XeriJect® formulation of teprotumumab
Announced an exclusive worldwide agreement with Beta Bionics for development of a new XeriSol™ formulation of glucagon for bi-hormonal pumps and pump systems
Hosting conference call and webcast today at 8:30 a.m. ET
“We grew total product revenue
First Quarter 2024 Highlights
|
Three months ended March 31, |
|
Change |
||||||||||
|
2024 |
|
2023 |
|
$ |
% |
|||||||
Product revenue (in thousands): |
|
|
|
|
|
|
|||||||
Gvoke |
$ |
16,579 |
|
$ |
15,033 |
|
$ |
1,546 |
|
10.3 |
|
||
Keveyis |
|
13,085 |
|
|
12,755 |
|
|
330 |
|
2.6 |
|
||
Recorlev |
|
10,599 |
|
|
4,477 |
|
|
6,122 |
|
136.7 |
|
||
Product revenue, net |
|
40,263 |
|
|
32,265 |
|
|
7,998 |
|
24.8 |
|
||
Royalty, contract and other revenue |
|
375 |
|
|
931 |
|
|
(556 |
) |
(59.7 |
) |
||
Total revenue |
$ |
40,638 |
|
$ |
33,196 |
|
$ |
7,442 |
|
22.4 |
|
||
Commercial Products
-
Gvoke®: First quarter net revenue was
$16.6 million $15.0 million 10% . Gvoke’s market share of the retail TRx glucagon market grew to over36% through late April and weekly Gvoke TRxs broke the 5,000 level in late April. -
Keveyis®: First quarter net revenue remained very strong at
$13.1 million 3% compared to the same period in 2023. Keveyis patient referrals remained strong with considerably lower patient loss in the quarter than anticipated. -
Recorlev®: First quarter net revenue was
$10.6 million $6.1 million 139% from the same period in 2023 and18% compared to the fourth quarter 2023.
Pipeline Program
- XeriSol™ levothyroxine (XP-8121): Successfully completed the Phase 2 clinical study. Data from the Phase 2 study will be available mid-2024.
Technology Partnerships
- XeriSol™: In May, Xeris entered into an exclusive worldwide collaboration and license agreement with Beta Bionics for the development and commercialization of a new and unique formulation of liquid stable glucagon for use in a bi-hormonal pump and pump systems.
-
XeriJect®: In January, Xeris entered into an exclusive worldwide license agreement for Amgen to develop, manufacture, and commercialize a subcutaneous formulation of teprotumumab using Xeris’ XeriJect® technology in Thyroid Eye Disease (TED). Under the terms of the License Agreement, Xeris has the potential to receive
$75 million
Cost of goods sold increased by
Research and development expenses increased by
Selling, general and administrative expenses increased by
Net Loss was
Cash, cash equivalents, and short-term investments at March 31, 2024 was
Shares outstanding at April 30, 2024 was 148,255,663.
First Quarter Conference Call and Webcast Details
Xeris will host a conference call and webcast on Thursday, May 9, 2024 at 8:30 a.m. Eastern Time.
To pre-register for the call, please go to the following link: https://www.netroadshow.com/events/login?show=7144015a&confId=62782. 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 Thursday, May 23, 2024 at US:1 929 458 6194, US Toll Free: 1 866 813 9403,
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/702822810
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
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 total revenue guidance for 2024, Xeris’ potential to receive milestones and royalties under a license agreement with Amgen, the expansion of collaboration partnerships such as with Beta Bionics, the impact of the Change Healthcare cyberattack, the timing of the availability of clinical study data, the market and therapeutic potential of its products and product candidates, the potential utility of its formulation platforms, 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.
XERIS BIOPHARMA HOLDINGS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) |
|||||||
|
Three Months Ended March 31, |
||||||
|
|
2024 |
|
|
|
2023 |
|
Product revenue, net |
$ |
40,263 |
|
|
$ |
32,265 |
|
Royalty, contract and other revenue |
|
375 |
|
|
|
931 |
|
Total revenue |
|
40,638 |
|
|
|
33,196 |
|
Costs and expenses: |
|
|
|
||||
Cost of goods sold |
|
5,971 |
|
|
|
5,319 |
|
Research and development |
|
7,821 |
|
|
|
4,838 |
|
Selling, general and administrative |
|
38,380 |
|
|
|
33,605 |
|
Amortization of intangible assets |
|
2,711 |
|
|
|
2,711 |
|
Total costs and expenses |
|
54,883 |
|
|
|
46,473 |
|
Loss from operations |
|
(14,245 |
) |
|
|
(13,277 |
) |
Other expense |
|
(4,428 |
) |
|
|
(3,557 |
) |
Net loss before benefit from income taxes |
|
(18,673 |
) |
|
|
(16,834 |
) |
Income tax (expense) benefit |
|
(307 |
) |
|
|
— |
|
Net loss |
$ |
(18,980 |
) |
|
$ |
(16,834 |
) |
|
|
|
|
||||
Net loss per common share - basic and diluted |
$ |
(0.14 |
) |
|
$ |
(0.12 |
) |
|
|
|
|
||||
Weighted average common shares outstanding - basic and diluted |
|
140,513,907 |
|
|
|
137,142,565 |
|
XERIS BIOPHARMA HOLDINGS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) |
|||||||
|
March 31, 2024 |
|
December 31, 2023 |
||||
|
(unaudited) |
|
|
||||
Assets |
|
|
|
||||
Current assets: |
|
|
|
||||
Cash and cash equivalents |
$ |
62,690 |
|
|
$ |
67,449 |
|
Short-term investments |
|
24,662 |
|
|
|
5,002 |
|
Trade accounts receivable, net |
|
37,414 |
|
|
|
39,197 |
|
Inventory |
|
40,878 |
|
|
|
38,838 |
|
Prepaid expenses and other current assets |
|
7,636 |
|
|
|
5,778 |
|
Total current assets |
|
173,280 |
|
|
|
156,264 |
|
Property and equipment, net |
|
5,783 |
|
|
|
5,971 |
|
Intangible assets, net |
|
107,053 |
|
|
|
109,764 |
|
Goodwill |
|
22,859 |
|
|
|
22,859 |
|
Operating lease right-of-use assets |
|
23,027 |
|
|
|
23,204 |
|
Other assets |
|
4,614 |
|
|
|
4,540 |
|
Total assets |
$ |
336,616 |
|
|
$ |
322,602 |
|
Liabilities and Stockholders’ Equity |
|
|
|
||||
Current liabilities: |
|
|
|
||||
Accounts payable |
$ |
7,094 |
|
|
$ |
11,565 |
|
Current operating lease liabilities |
|
4,624 |
|
|
|
3,495 |
|
Other accrued liabilities |
|
22,391 |
|
|
|
23,510 |
|
Accrued trade discounts and rebates |
|
22,560 |
|
|
|
22,149 |
|
Accrued returns reserve |
|
14,593 |
|
|
|
14,198 |
|
Current portion of contingent value rights |
|
1,021 |
|
|
|
19,109 |
|
Other current liabilities |
|
801 |
|
|
|
1,167 |
|
Total current liabilities |
|
73,084 |
|
|
|
95,193 |
|
Long-term debt, net of unamortized debt issuance costs |
|
229,674 |
|
|
|
190,932 |
|
Non-current contingent value rights |
|
— |
|
|
|
1,379 |
|
Non-current operating lease liabilities |
|
34,397 |
|
|
|
34,764 |
|
Deferred tax liabilities |
|
2,575 |
|
|
|
2,268 |
|
Other liabilities |
|
6,064 |
|
|
|
4,848 |
|
Total liabilities |
|
345,794 |
|
|
|
329,384 |
|
Total stockholders’ equity (deficit) |
|
(9,178 |
) |
|
|
(6,782 |
) |
Total liabilities and stockholders’ equity (deficit) |
$ |
336,616 |
|
|
$ |
322,602 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240509287355/en/
Investor Contact
Allison Wey
Senior Vice President, Investor Relations and Corporate Communications
awey@xerispharma.com
Source: Xeris Biopharma Holdings, Inc.
FAQ
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