Xeris Biopharma Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Events
- Xeris Biopharma achieved significant revenue growth in the fourth quarter and full year 2023, with a strong increase in total revenue.
- The company ended 2023 with a healthy cash position and positive cash flow, indicating financial stability.
- Xeris entered into a strategic worldwide license agreement for XeriJect® formulation, showcasing progress in partnerships and technology advancements.
- The company refinanced and upsized its term loan to reduce costs and provide additional capital for future growth.
- Xeris provided optimistic guidance for full-year 2024, indicating confidence in continued growth and financial performance.
- Net loss was reported for the three months and full year ended December 31, 2023, indicating financial challenges.
- Cost of goods sold and research and development expenses increased, potentially impacting profitability.
- Selling, general, and administrative expenses also rose, which could affect overall financial performance.
- Cash, cash equivalents, and short-term investments decreased from the prior year, raising concerns about liquidity.
- The company's net loss per share for the full year ended December 31, 2023, was significant, impacting shareholder value.
Insights
The reported revenue growth of 34% in Q4 and 49% for the full year by Xeris Biopharma Holdings is a robust indicator of the company's upward trajectory. Particularly noteworthy is the cash flow positive status achieved in Q4, which is a critical milestone for biopharmaceutical companies, often burdened by high research and development costs. The company's ability to refinance debt at a lower cost of capital is a strategic move that reflects positively on its financial management and creditworthiness. The guidance for 2024 indicates confidence in continued revenue growth, although the projected year-end cash position shows a potential decrease from 2023 levels, which could imply substantial planned investments or anticipated cash burn.
From a market perspective, the increased market share of Gvoke and the significant growth in Recorlev's patient numbers suggest that Xeris is effectively penetrating its target markets. The licensing agreement for the XeriJect® formulation with Amgen could be a game-changer, offering a revenue stream from royalties and milestones that diversifies the company's income sources. The positive market reception to their commercial products and the progress in their pipeline, such as the completed enrollment for the Phase 2 study of XP-8121, could attract investor attention and potentially impact the company's stock valuation.
From a clinical development standpoint, the progress of Xeris' internal pipeline program, XP-8121, is significant as it represents potential future revenue streams and therapeutic advancements. The Phase 2 clinical study completion is a critical step towards bringing new treatments to market. The partnership with Amgen and the utilization of XeriJect® technology for a new formulation of teprotumumab, a drug for Thyroid Eye Disease, underscores the company's innovative approach and could lead to broader applications of their proprietary technology in other treatments.
Achieved Total Revenue of over
Ended 2023 with over
Entered into a worldwide license agreement for XeriJect® formulation of teprotumumab
Refinanced and upsized Hayfin term loan to a lower overall cost of capital with additional capital available to invest for future growth
Provides full-year 2024 guidance: total net revenue of
Hosting conference call and webcast today at 8:30 a.m. ET
“2023 was another year of exceptional performance and growth for Xeris. We executed on all fronts: our commercial products grew over
Fourth Quarter 2023 Highlights
|
Three months ended December 31, |
|
Change |
|||||||||||
|
|
2023 |
|
|
|
2022 |
|
|
$ |
|
% |
|||
Product revenue (in thousands): |
|
|
|
|
|
|
||||||||
Gvoke |
$ |
18,639 |
|
$ |
14,932 |
|
$ |
3,707 |
24.8 |
|||||
Keveyis |
|
14,064 |
|
|
|
13,801 |
|
|
|
263 |
|
1.9 |
|
|
Recorlev |
|
9,806 |
|
|
|
3,806 |
|
|
|
6,000 |
|
157.6 |
|
|
Product revenue, net |
|
42,509 |
|
|
|
32,539 |
|
|
|
9,970 |
|
30.6 |
|
|
Royalty, contract and other revenue |
|
1,881 |
|
|
|
605 |
|
|
|
1,276 |
|
210.9 |
|
|
Total revenue |
$ |
44,390 |
|
|
$ |
33,144 |
|
|
$ |
11,246 |
|
33.9 |
|
Commercial Products
-
Gvoke®: Fourth quarter 2023 net revenue was
as compared to$18.6 million in the fourth quarter of 2022 – an increase of approximately$14.9 million 25% . Gvoke prescriptions topped 59,000 for the first time, growing43% compared to the same period in 2022. Gvoke’s market share of the retail TRx glucagon market grew to over32% through late February. -
Keveyis®: Fourth quarter net revenue was
– an increase of approximately$14.1 million 2% compared to the same period in 2022. -
Recorlev®: Fourth quarter net revenue was
– an increase of$9.8 million compared to the same period of 2022. The average number of patients on Recorlev increased over$6.0 million 145% from the same period in 2022.
Pipeline Program
- XeriSol™ levothyroxine (XP-8121): The Phase 2 clinical study has completed enrollment. Data from the Phase 2 study should be available mid-2024.
Technology Partnerships
-
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
in development, regulatory, and sales-based milestones, as well as escalating single-digit royalties based on future sales of TEPEZZA® using the XeriJect® technology.$75 million
Full-year 2023 Financial Results
|
Years Ended December 31, |
|
Change |
|||||||||||
|
|
2023 |
|
|
|
2022 |
|
|
$ |
|
% |
|||
Product revenue (in thousands): |
|
|
|
|
|
|
||||||||
Gvoke |
$ |
67,045 |
|
$ |
52,527 |
|
$ |
14,518 |
27.6 |
|||||
Keveyis |
|
56,772 |
|
|
|
49,307 |
|
|
|
7,465 |
|
15.1 |
|
|
Recorlev |
|
29,547 |
|
|
|
7,429 |
|
|
|
22,118 |
|
297.7 |
|
|
Product revenue, net |
|
153,364 |
|
|
|
109,263 |
|
|
|
44,101 |
|
40.4 |
|
|
Royalty, contract and other revenue |
|
10,550 |
|
|
|
985 |
|
|
|
9,565 |
|
971.1 |
|
|
Total revenue |
$ |
163,914 |
|
|
$ |
110,248 |
|
|
$ |
53,666 |
|
48.7 |
|
-
Gvoke®: Net revenue was
for the full year ended December 31, 2023, a$67.0 million 28% increase compared to prior year. Gvoke prescriptions for the full-year 2023 were over 215,000 prescriptions, growing48.9% compared to 2022. The growth in product demand was partially offset by a decrease in net pricing. -
Keveyis®: Net revenue was
for the full year ended December 31, 2023, a$56.8 million 15% increase from last year. This increase was driven by higher patient demand coupled with an increase in net pricing. This performance exceeds the revenue milestone that triggered the contingent value rights (CVR) for Strongbridge Biopharma shareholders as record on October 5, 2021. (See Upcoming Events for more details.)$40 million -
Recorlev®: Net revenue was
for the full year ended December 31,2023, a$29.5 million increase from last year, driven primarily by increases in the number of patients on therapy.$22.1 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 December 31, 2023 was
Shares outstanding at February 29, 2024 was 140,453,467.
Recent and Upcoming Events
-
On March 6, 2024, Xeris announced the refinancing of its existing senior secured term loan agreement with Hayfin Capital Management LLC to provide the Company with a facility size of
at close, lowering its overall cost of capital and providing additional working capital to invest in the Company’s business plan. An additional$200.0 million will be available to settle, if needed, the outstanding senior convertible notes that mature mid-2025. In conjunction with the new loan agreement, Xeris paid the balance of the$15.2 million debt facility to Hayfin, plus associated interest and fees.$150.0 million - On or about March 27, 2024, Xeris will issue approximately 7.5 million common shares of Xeris Biopharma Holdings to Strongbridge Biopharma shareholders of record as of October 5, 2021 for the achievement of the Keveyis CVR revenue milestone in 2023. This will bring total common shares outstanding to approximately 148 million.
-
Xeris will participate in the following investor conferences:
-
Leerink Partners Global Biopharma Conference– March 11-13, 2024 in
Miami -
23rd Annual Needham Virtual Healthcare Conference – April 8-12, 2024
Details of each event will be available on Xeris’ website. Contact the respective sponsor to request a 1x1 meeting.
-
Leerink Partners Global Biopharma Conference– March 11-13, 2024 in
Fourth Quarter Conference Call and Webcast Details
Xeris will host a conference call and webcast on Wednesday, March 6, 2024 at 8:30 a.m. Eastern Time. To pre-register for the conference call, please use the following link:
https://www.netroadshow.com/events/login?show=71651ed6&confId=60623. 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, March 20, 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.
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 financial guidance for 2024, including growth in revenue guidance and year-end cash position, cash management, Xeris’ potential to receive milestones and royalties under a license agreement with Amgen, its ability to access additional capital from Hayfin for potential strategic opportunities, the timing of an issuance of shares in connection with the achievement of the Keveyis CVR revenue milestone, 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)
|
|||||||||||||||
|
Three Months Ended December 31, |
|
Years ended December 31, |
||||||||||||
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Product revenue, net |
$ |
42,509 |
|
|
$ |
32,539 |
|
|
$ |
153,364 |
|
|
$ |
109,263 |
|
Royalty, contract and other revenue |
|
1,881 |
|
|
|
605 |
|
|
|
10,550 |
|
|
|
985 |
|
Total revenue |
|
44,390 |
|
|
|
33,144 |
|
|
|
163,914 |
|
|
|
110,248 |
|
Costs and expenses: |
|
|
|
|
|
|
|
||||||||
Cost of goods sold |
|
7,570 |
|
|
|
6,291 |
|
|
|
28,645 |
|
|
|
22,634 |
|
Research and development |
|
6,382 |
|
|
|
4,955 |
|
|
|
22,341 |
|
|
|
20,966 |
|
Selling, general and administrative |
|
37,568 |
|
|
|
34,357 |
|
|
|
146,095 |
|
|
|
137,745 |
|
Amortization of intangible assets |
|
2,711 |
|
|
|
2,711 |
|
|
|
10,843 |
|
|
|
10,843 |
|
Total costs and expenses |
|
54,231 |
|
|
|
48,314 |
|
|
|
207,924 |
|
|
|
192,188 |
|
Loss from operations |
|
(9,841 |
) |
|
|
(15,170 |
) |
|
|
(44,010 |
) |
|
|
(81,940 |
) |
Other expense |
|
(3,785 |
) |
|
|
1,902 |
|
|
|
(19,494 |
) |
|
|
(14,144 |
) |
Net loss before benefit from income taxes |
|
(13,626 |
) |
|
|
(13,268 |
) |
|
|
(63,504 |
) |
|
|
(96,084 |
) |
Benefit from income taxes |
|
236 |
|
|
|
338 |
|
|
|
1,249 |
|
|
|
1,424 |
|
Net loss |
$ |
(13,390 |
) |
|
$ |
(12,930 |
) |
|
$ |
(62,255 |
) |
|
$ |
(94,660 |
) |
|
|
|
|
|
|
|
|
||||||||
Net loss per common share - basic and diluted |
$ |
(0.10 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.45 |
) |
|
$ |
(0.70 |
) |
|
|
|
|
|
|
|
|
||||||||
Weighted average common shares outstanding - basic and diluted |
|
138,124,878 |
|
|
|
135,986,345 |
|
|
|
137,674,857 |
|
|
|
135,628,721 |
|
XERIS BIOPHARMA HOLDINGS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands)
|
|||||||
|
December 31, 2023 |
|
December 31, 2022 |
||||
|
|
|
|
||||
Assets |
|
|
|
||||
Current assets: |
|
|
|
||||
Cash and cash equivalents |
$ |
67,449 |
|
|
$ |
121,966 |
|
Short-term investments |
|
5,002 |
|
|
|
— |
|
Trade accounts receivable, net |
|
39,197 |
|
|
|
30,830 |
|
Inventory |
|
38,838 |
|
|
|
24,735 |
|
Prepaid expenses and other current assets |
|
5,778 |
|
|
|
9,287 |
|
Total current assets |
|
156,264 |
|
|
|
186,818 |
|
Property and equipment, net |
|
5,971 |
|
|
|
5,516 |
|
Intangible assets, net |
|
109,764 |
|
|
|
120,607 |
|
Goodwill |
|
22,859 |
|
|
|
22,859 |
|
Operating lease right-of-use assets |
|
23,204 |
|
|
|
3,992 |
|
Other assets |
|
4,540 |
|
|
|
4,730 |
|
Total assets |
$ |
322,602 |
|
|
$ |
344,522 |
|
Liabilities and Stockholders’ Equity |
|
|
|
||||
Current liabilities: |
|
|
|
||||
Accounts payable |
$ |
11,565 |
|
|
$ |
4,606 |
|
Current operating lease liabilities |
|
3,495 |
|
|
|
1,580 |
|
Other accrued liabilities |
|
23,510 |
|
|
|
36,786 |
|
Accrued trade discounts and rebates |
|
22,149 |
|
|
|
16,818 |
|
Accrued returns reserve |
|
14,198 |
|
|
|
11,173 |
|
Current portion of contingent value rights |
|
19,109 |
|
|
|
— |
|
Other current liabilities |
|
1,167 |
|
|
|
2,658 |
|
Total current liabilities |
|
95,193 |
|
|
|
73,621 |
|
Long-term debt, net of unamortized debt issuance costs |
|
190,932 |
|
|
|
187,075 |
|
Non-current contingent value rights |
|
1,379 |
|
|
|
25,688 |
|
Non-current operating lease liabilities |
|
34,764 |
|
|
|
9,402 |
|
Deferred tax liabilities |
|
2,268 |
|
|
|
3,518 |
|
Other liabilities |
|
4,848 |
|
|
|
31 |
|
Total liabilities |
|
329,384 |
|
|
|
299,335 |
|
Total stockholders’ equity (deficit) |
|
(6,782 |
) |
|
|
45,187 |
|
Total liabilities and stockholders’ equity |
$ |
322,602 |
|
|
$ |
344,522 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240306129214/en/
Investor Contact
Allison Wey
Senior Vice President, Investor Relations and Corporate Communications
awey@xerispharma.com
Source: Xeris Biopharma Holdings, Inc.
FAQ
What was Xeris Biopharma's total revenue in the fourth quarter of 2023?
What was Xeris Biopharma's full-year revenue for 2023?
What was the company's cash position at the end of 2023?
What agreement did Xeris Biopharma enter into for teprotumumab formulation?