Achieved record revenue of $48.3M – a 27%
increase from prior quarter, and a 63% increase from same period
prior year
Tightens full-year 2023 revenue guidance from
$155M-$165M to $160M-$165M
Ended Q3 with $66.0M in cash, cash equivalents
and short-term investments and remains on track to achieve cash
flow breakeven in the fourth quarter
Extended maturity of approximately two-thirds
of 2025 Convertible Senior Notes to 2028
Successfully formulated the prespecified target
product profile of the XeriJect™ formulation of TEPEZZA®
Hosting conference call and webcast today at
8:30 a.m. ET
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 third
quarter and nine months ended September 30, 2023 and corporate
highlights.
“We continue to demonstrate record revenue growth as we execute
on our strategy. Because of this strong performance, we are further
tightening our full year 2023 revenue guidance from $155 million -
$165 million to $160 million - $165 million, which is at the high
end of our original range,” said Paul R. Edick, Chairman and CEO of
Xeris Biopharma. “Due to continued disciplined expense management
coupled with our strong revenue growth we are confident we will
achieve cash flow breakeven in the fourth quarter.”
Third Quarter 2023
Highlights
Three months ended September
30,
Change
2023
2022
$
%
Product revenue (in thousands):
Gvoke
$
17,735
$
13,663
$
4,072
29.8
Keveyis
15,865
13,371
2,494
18.7
Recorlev
8,097
2,520
5,577
nm
Product revenue, net
41,697
29,554
12,143
41.1
Royalty, contract and other revenue
6,623
171
6,452
nm
Total revenue
$
48,320
$
29,725
$
18,595
62.6
nm - not meaningful
Commercial Products
- Gvoke®: Third quarter 2023 net revenue was $17.7 million
as compared to $13.7 million in the third quarter of 2022 – an
increase of approximately 30%. Gvoke prescriptions topped 58,000
for the first time, growing 52% compared to the same period in
2022. Gvoke’s market share of the retail TRx glucagon market grew
to over 31% through late October.
- Keveyis®: Third quarter net revenue was $15.9 million –
an increase of approximately 19% compared to the same period in
2022. The average number of patients on Keveyis increased
approximately 5% from the same period in 2022.
- Recorlev®: Third quarter net revenue was $8.1 million –
an increase of $5.6 million compared to the same period of 2022.
The average number of patients on Recorlev increased over 203% from
the same period in 2022.
Pipeline Program
- XeriSol® levothyroxine (XP-8121): The Phase 2 clinical
study is over 85% enrolled, and the study should be completed in
the first half of 2024 based on the current enrollment rate.
Technology Partnerships
- Horizon/Amgen: Xeris successfully formulated the
prespecified target product profile of the XeriJect™ formulation of
TEPEZZA® which triggered revenue of $6.0 million in the third
quarter from a milestone payment under the research collaboration
and option agreement with Horizon (subsequently acquired by Amgen)
that was signed in November 2022. The payment was subsequently
received in the fourth quarter. Amgen has the option to license the
XeriJect technology to further the development of an
ultra-concentrated, ready-to-use, subcutaneous injection of
TEPEZZA®.
Year-to-Date 2023 Financial
Results
Nine Months Ended September
30,
Change
2023
2022
$
%
Product revenue (in thousands):
Gvoke
$
48,406
$
37,595
$
10,811
28.8
Keveyis
42,708
35,506
7,202
20.3
Recorlev
19,741
3,623
16,118
nm
Product revenue, net
110,855
76,724
34,131
44.5
Royalty, contract and other revenue
8,669
380
8,289
nm
Total revenue
$
119,524
$
77,104
$
42,420
55.0
nm - not meaningful
- Gvoke®: Net revenue was $48.4 million for the nine
months ended September 30, 2023, a 29% increase compared to prior
year. Gvoke prescriptions for the first three quarters of 2023 were
over 156,000 TRx’s, growing 51% 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 $42.7 million for the nine
months ended September 30, 2023, a 20% increase from last year.
This increase was driven by higher patient demand and an increase
in net pricing.
- Recorlev®: Net revenue was $19.7 million for the nine
months ended September 30,2023, a $16.1 million increase from last
year, driven primarily by increases in the number of patients on
therapy.
Cost of goods sold increased by $2.9 million for the
three months ended September 30, 2023 compared to the same period
ended September 30, 2022. The increase was mainly attributable to
higher product sales. Cost of goods sold increased by $4.7 million
for the nine months ended September 30, 2023 compared to the same
period ended September 30, 2022. The increase was mainly
attributable to higher product sales partially offset by the
product mix and a one-time contract credit in the first quarter of
2023.
Research and development expenses decreased by $1.0
million for the three months ended September 30, 2023 compared to
the same period ended September 30, 2022 driven by lower product
development costs. Research and development expenses were flat in
the nine months ended September 30, 2023 compared to the same
period ended September 30, 2022.
Selling, general and administrative expenses increased by
$2.8 million and $5.1 million for the three and nine months ended
2023, respectively, compared to the same periods ended September
30, 2022, due to higher personnel costs and rent expenses related
to the new lease commenced in April 2023.
Net Loss was $12.2 million, or $0.09 per share, for the
three months ended September 30, 2023 and a net loss of $48.9
million, or $0.36 per share, for the nine months ended September
30, 2023.
Cash, cash equivalents, and short-term investments at
September 30, 2023 was $66.0 million compared to $122.0 million at
December 31, 2022.
Shares outstanding at October 31, 2023 was
138,124,595.
Upcoming Events
Xeris will participate in the following investor
conferences:
- Jefferies London Healthcare Conference, November 14-16,
2023
- 14th Annual Craig-Hallum Alpha Select Conference, November 16,
2023 (1x1s only)
- 35th Annual Piper Sandler Healthcare Conference, November
28-30, 2023
Details of each event will be available on Xeris’ website.
Contact the respective sponsor to request a 1x1 meeting.
Third Quarter Conference Call and Webcast Details
Xeris will host a conference call and webcast on Thursday,
November 9, 2023 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=59946218&confId=55658.
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, November 23, 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: 328140.
In addition, a live audio of the conference call will be
available as a webcast. To join the webcast, please visit “Events”
on the investor relations page of the Company’s website at
www.xerispharma.com or use the following link:
https://events.q4inc.com/attendee/482975153.
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 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 2023,
including projections that the company will achieve cash flow
breakeven in the fourth quarter and revenue guidance, the market
and therapeutic potential of its products and product candidates,
the timing of clinical studies and trials, including advancement of
its levothyroxine clinical program and expected Phase 2 study
completion in the first half of 2024, the potential utility of its
formulation platforms, cash management, 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,
2023
2022
2023
2022
Product revenue, net
$
41,697
$
29,554
$
110,855
$
76,724
Royalty, contract and other revenue
6,623
171
8,669
380
Total revenue
48,320
29,725
119,524
77,104
Costs and expenses:
Cost of goods sold
8,201
5,260
21,075
16,343
Research and development
5,034
6,043
15,959
16,011
Selling, general and administrative
37,287
34,491
108,527
103,388
Amortization of intangible assets
2,711
2,711
8,132
8,132
Total costs and expenses
53,233
48,505
153,693
143,874
Loss from operations
(4,913)
(18,780)
(34,169)
(66,770)
Other expense
(7,614)
(3,390)
(15,709)
(16,046)
Net loss before benefit from income
taxes
(12,527)
(22,170)
(49,878)
(82,816)
Benefit from income taxes
338
339
1,013
1,086
Net loss
$
(12,189)
$
(21,831)
$
(48,865)
$
(81,730)
Net loss per common share - basic and
diluted
$
(0.09)
$
(0.16)
$
(0.36)
$
(0.60)
Weighted average common shares outstanding
- basic and diluted
138,059,781
135,951,761
137,523,202
135,508,203
XERIS BIOPHARMA HOLDINGS,
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
September 30, 2023
December 31, 2022
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
46,143
$
121,966
Short-term investments
19,832
—
Trade accounts receivable, net
45,966
30,830
Inventory
38,143
24,735
Prepaid expenses and other current
assets
7,967
9,287
Total current assets
158,051
186,818
Property and equipment, net
6,185
5,516
Intangible assets, net
112,475
120,607
Goodwill
22,859
22,859
Operating lease right-of-use assets
23,407
3,992
Other assets
4,807
4,730
Total assets
$
327,784
$
344,522
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
$
12,078
$
4,606
Current operating lease liabilities
2,366
1,580
Other accrued liabilities
19,073
36,786
Accrued trade discounts and rebates
21,554
16,818
Accrued returns reserve
13,328
11,173
Current portion of contingent value
rights
17,517
—
Other current liabilities
1,123
2,658
Total current liabilities
87,039
73,621
Long-term debt, net of unamortized debt
issuance costs
190,423
187,075
Non-current contingent value rights
5,099
25,688
Non-current operating lease
liabilities
35,154
9,402
Deferred tax liabilities
2,504
3,518
Other liabilities
3,700
31
Total liabilities
323,919
299,335
Total stockholders’ equity
3,865
45,187
Total liabilities and stockholders’
equity
$
327,784
$
344,522
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231109523978/en/
Allison Wey Senior Vice President, Investor Relations and
Corporate Communications awey@xerispharma.com 312-736-1237
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