CHICAGO--(
BUSINESS WIRE
)--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.
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
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