Launched Recorlev® and Gvoke® Kit
Achieved Q1 net product revenue of $21.9M – a
33% increase from same period prior year on a pro forma basis
Ended Q1 with $132.1M in cash, cash equivalents
and short-term investments
Affirming 2022 guidance for combined net
product revenues of $105M - $120M, $50M in synergies, 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
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a
biopharmaceutical company developing and commercializing unique
therapies for patient populations in endocrinology, neurology, and
gastroenterology today announced financial results for the first
quarter and recent highlights.
“We had another very good quarter in 1Q 2022 with continued
increases in patients on Gvoke and Keveyis. In addition to this
growth, we launched Recorlev and Gvoke Kit, and we added
considerable cash to our balance sheet during the first three
months of the year,” said Paul R. Edick, Chairman and CEO of Xeris
Biopharma. “Our first quarter performance gives us confidence that
we can achieve our 2022 revenue and year-end cash guidance and
achieve cash flow breakeven by year-end 2023. We look forward to
continuing our steady and strong execution across our commercial
products and advancement of our development pipeline.”
First Quarter Highlights and Upcoming
Events
- Gvoke®: First quarter 2022 prescriptions topped 30,000 for the
first time, growing more than 88% 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 April. In March, Xeris launched
Gvoke® Kit, the first ready-to-use liquid glucagon in a single dose
vial and syringe kit for rescue.
- Keveyis®: The number of patients on Keveyis increased 12% from
the same period in 2021.
- Recorlev®: In February 2022, Xeris launched Recorlev and is
exclusively available through a specialty pharmacy. The Company has
established Xeris CareConnection™, a comprehensive support program,
which includes $0 co-pay for commercially insured patients,
one-on-one support and education for patients, and reimbursement
and access support.
- In January, Xeris entered into a Securities Purchase Agreement
with Armistice Capital Master Fund Ltd. for $30.0 million and the
issuance of 10,238,908 shares of common stock and warrants to
purchase 5,119,454 shares of common stock at an exercise price of
$3.223 per share.
- In March, Xeris entered into a senior secured term loan
agreement with Hayfin Capital Management LLP to provide the Company
with $150.0 million. At closing, Xeris drew down $100.0 million to
repay its existing debt facility of $43.5 million with Oxford
Finance LLC and Silicon Valley Bank and provide additional working
capital to fund the Company’s business plan. An additional $50.0
million will be available for the Company to draw until March
2023.
- Xeris will participate at the H. C. Wainwright Global
Investment Conference, May 23-26, in Miami
- Xeris will present data at the AACE Annual Meeting, May 12-14,
in San Diego and at ISPOR 2022, May 15-18, in Washington DC
First Quarter 2022 Financial
Results
Net product revenue increased by $13.9 million or 172%
for the three months ended March 31, 2022 compared to March 31,
2021. The increase was the result of higher sales of Gvoke and
sales attributable to the products, Keveyis and Recorlev, that we
acquired in Q4, 2021. On a pro forma basis, net product revenue
increased 33% or $5.5 million for the three months ended March 31,
2022 compared to March 31, 2021. This increase was driven by higher
sales of Gvoke, Keveyis and the launch of Recorlev.
Cost of goods sold increased by $4.4 million or 244% for
the three months ended March 31, 2022 compared to March 31, 2021.
An increase in sales and product mix comprised $3.1 million and
$0.8 million of the change.
Research and development expenses increased by $2.2
million or 55% for the three months ended March 31, 2022 compared
to March 31, 2021. Higher pharmaceutical process development and
clinical service costs accounted for $2.0 million of the increase
for the three months ending March 31, 2022.
Selling, general and administrative expenses increased by
$16.8 million or 88% for the three months ending March 31, 2022
compared to March 31, 2021. We incurred $11.5 million of increased
commercial-related costs, including an increase to our sales force
and increased commercial support for Gvoke, Keveyis and the launch
of Recorlev. In addition, $2.3 million of the increase related to
the acquisition of Strongbridge, primarily restructuring and
related employee costs. The remaining change was due to an increase
in general expenses given the growth of the Company.
Net Loss for the first quarter ended March 31, 2022, was
$33.7 million, or $0.25 per share, compared to a net loss of $18.4
million, or $0.30 per share, for the same period in 2021.
Cash, cash equivalents, and short-term investments at
March 31, 2022 was $132.1 million compared to $102.4 million at
December 31, 2021. Total shares outstanding at April 30, 2022 was
135,530,756.
Conference Call and Webcast Details
Xeris will host a conference call and webcast today, Wednesday,
May 11, 2022, at 8:30 a.m. Eastern Time. To pre-register for the
conference call please use this link:
https://www.incommglobalevents.com/registration/q4inc/10525/xeris-biopharma-first-quarter-2022-financial-results-conference-call-and-webcast/
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, May 25, 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: 723527. 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 biopharmaceutical company developing
and commercializing unique therapies for patient populations in
endocrinology, neurology, and gastroenterology. 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 availability of up to $50 million of additional
funding under the Company’s credit agreement with Hayfin, 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 subject to risks and uncertainties that may cause
actual results to differ materially from those indicated in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, reliance on third-party suppliers for
Gvoke®, Ogluo®, Keveyis and Recorlev, the regulatory approval of
its product candidates, its ability to market and sell its
products, failure to realize the expected benefits of the
acquisition of Strongbridge Biopharma, the impact of the ongoing
COVID-19 pandemic on Xeris, including impact on access to health
care provider facilities, changes in global, political, economic,
business, competitive, market and regulatory forces, future
exchange and interest rates, changes in tax laws, regulations,
rates and policies, future business acquisitions or disposals and
competitive developments and the other risks described in our
Annual Report on Form 10-K and other reports we file from time to
time with the SEC. 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 Item 1A, “Risk Factors,” in Xeris’ Annual
Report on Form 10-K filed with the SEC, 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.
XERIS BIOPHARMA HOLDINGS,
INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(in thousands, except share and
per share data)
(unaudited)
Three Months Ended
March 31,
2022
2021
Product revenue, net
$
21,910
$
8,051
Royalty, contract and other revenue
163
144
Total revenue
22,073
8,195
Costs and expenses:
Cost of goods sold, excluding amortization
of intangible assets
6,273
1,826
Research and development
6,250
4,032
Selling, general and administrative
35,913
19,077
Amortization of intangible assets
2,711
—
Total costs and expenses
51,147
24,935
Loss from operations
(29,074
)
(16,740
)
Other expense
(5,048
)
(1,671
)
Net loss before benefit from income
taxes
(34,122
)
(18,411
)
Benefit from income taxes
408
—
Net loss
$
(33,714
)
$
(18,411
)
Net loss per common share - basic and
diluted
$
(0.25
)
$
(0.30
)
Weighted average common shares outstanding
- basic and diluted
135,032,782
61,245,220
XERIS BIOPHARMA HOLDINGS,
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
March 31, 2022
December 31, 2021
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
103,771
$
67,271
Short-term investments
28,377
35,162
Trade accounts receivable, net
23,383
17,456
Inventory
16,872
18,118
Prepaid expenses and other current
assets
5,147
4,589
Total current assets
177,550
142,596
Property and equipment, net
6,291
6,627
Goodwill
22,859
22,859
Intangible assets, net
128,739
131,450
Other assets
2,184
829
Total assets
$
337,623
$
304,361
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
$
11,091
$
8,924
Other accrued liabilities
34,358
49,088
Accrued trade discounts and rebates
14,993
15,041
Accrued returns reserve
5,431
4,000
Other current liabilities
619
1,987
Total current liabilities
66,492
79,040
Long-term debt, net of unamortized debt
issuance costs
137,639
88,067
Contingent value rights
25,347
22,531
Supply agreement liability, less current
portion
—
5,991
Deferred rent
6,942
6,883
Deferred tax liabilities
4,534
4,942
Other liabilities
214
1,676
Total liabilities
241,168
209,130
Total stockholders’ equity
96,455
95,231
Total liabilities and stockholders’
equity
$
337,623
$
304,361
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220511005191/en/
Allison Wey Senior Vice President, Investor Relations and
Corporate Communications awey@xerispharma.com 312-736-1237
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