Acquisition and integration of Strongbridge
Biopharma completed; $50M in synergies to be realized by year-end
2022
Recorlev® approved by FDA
FY ‘21 pro forma net product revenues of $79M –
a 56% increase from prior year
Well-capitalized with cash, cash equivalents,
and short-term investments of $102.4M at YE 2021
Double-digit net product revenues growth
expected in 2022 to be $105M - $120M
Cash position further strengthened with a
recent PIPE and the restructuring of debt with Hayfin Capital; 2022
year-end cash, cash equivalents, and short-term investments of
$90M-$110M expected
Cash flow breakeven expected by year-end
2023
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, and Xeris Pharmaceuticals, Inc., today announced
financial results for the fourth quarter and full-year 2021 and
recent highlights.
“During 2021, we made significant progress toward achieving
critical mass and becoming a fully integrated pharmaceutical
company with the acquisition of Strongbridge, the continued growth
of Gvoke and Keveyis, and the recent approval and launch of our
third commercial product, Recorlev,” said Paul R. Edick, Chairman
and CEO of Xeris Biopharma. “2022 is all about execution and
building long-term shareholder value. With three commercial
products in large addressable markets and a strong cash position,
we believe we can achieve 2022 net product revenues in the range of
$105 million to $120 million and drive to cash flow breakeven by
year-end 2023.”
Fourth Quarter and Full-year 2021
Highlights and Recent Events
Marketed Products
- Gvoke®: Fourth quarter 2021 prescriptions topped 29,000 for the
first time, growing more than 85% compared to the same period in
2020. Gvoke’s market share of the retail TRx glucagon market grew
to approximately 17% at year-end. In June, the FDA approved the
extension of room temperature shelf-life of the Gvoke 1mg HypoPen
and PFS from 24 months to 30 months. In August, the FDA approved
the sNDA for the Gvoke Kit®, which will be available in March
2022.
- Keveyis®: Full-year pro forma 2021 net revenues for Keveyis
were at the high end of the previously announced guidance of $38-40
million.
- Ogluo®: In December, Xeris’ commercialization partner, Tetris
Pharma launched Ogluo® in the UK. Tetris plans to launch Ogluo in
several European countries in 2022.
- Recorlev®: On December 30, 2021, The U.S. Food and Drug
Administration (FDA) approved Recorlev for the treatment of
endogenous hypercortisolemia in adult patients with Cushing’s
syndrome for whom surgery is not an option or has not been
curative. In February 2022, Xeris launched Recorlev and is now
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.
Pipeline Programs
- Levothyroxine: Xeris anticipates having data from its Phase 1
single ascending dose study in the third quarter 2022.
- Exercise-induced Hypoglycemia (EIH): Xeris submitted an IND in
February 2022 and recently received FDA clearance. The Company is
actively planning a new phase 2 clinical program by the end of 2022
to further address the management of EIH in people with diabetes
who use insulin.
- XeriJect™ Technology Platform Collaborations: Xeris has four
ongoing evaluation projects with large pharmaceutical companies,
which includes Merck, for the purpose of engineering ultra-high
concentration, ready-to-use formulations.
Corporate Highlights
- On October 5, 2021, Xeris completed its acquisition of
Strongbridge Biopharma plc.
- On January 2, 2022, 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.
- On March 8, 2022, Xeris entered into a senior secured term loan
agreement with Hayfin Capital Management LLP to provide the Company
with $150.0 million. On the closing date, 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 during the 12-month period
following the closing date.
Fourth Quarter and Full-year 2021
Financial Results
Net product revenues increased by $14.3 million or 201%
and $29.1 million or 145% for the three and twelve months ended
December 31, 2021, respectively, compared to December 31, 2020. The
increases were due to an increased demand and the acquisition of a
new product, Keveyis.
Cost of goods sold increased by $1.5 million or 43% and
$4.0 million or 43% for the three and twelve months ended December
31, 2021, respectively, compared to December 31, 2020. The
increases were due to increased sales, primarily offset by lower
excess and obsolete.
Research and development expenses increased by $5.0
million or 97% and $4.2 million or 20% for the three- and
twelve-months ended December 31, 2021, respectively, compared to
December 31, 2020. Higher pharmaceutical process development and
clinical service costs accounted for $3.7 million and $4.3 million
of the increase for the three- and twelve-months ending December
31, 2021.
Selling, general and administrative expenses increased by
$36.2 million or 201% and $52.0 million or 71% for the three- and
twelve-months ending December 31, 2021, respectively, compared to
December 31, 2020. The increases are primarily driven by costs
associated with the Strongbridge acquisition of approximately $18.3
million and $24.4 million for the three-and twelve-months ending,
respectively. Additionally, increases in sales force and commercial
related expenses accounted for approximately $15.7 million and
$16.8 million for the three- and twelve-months ending,
respectively.
Net Loss for the fourth quarter ended December 31, 2021,
was $50.8 million, or $0. 42 per share, compared to a net loss of
$21.9 million, or $0.41 per share, for the same period in 2020. For
the full year ended December 31, 2021, the Company reported a net
loss of $122.7 million, or $1.55 per share, compared to a net loss
of $91.1 million, or $2.14 per share, for the same period in
2020.
Cash, cash equivalents, and short-term investments at
December 31, 2021, was $102.4 million compared to $133.8 million at
December 31, 2020. Total shares outstanding at February 28, 2022,
was 135,523,511.
Financial Outlook
The Company is providing the following financial guidance:
- Net product revenue of $105 million to $120 million for
full-year 2022
- Year-end 2022 cash, cash equivalents, and short-term
investments in the range of $90 million to $110 million
- Cash flow breakeven by year-end 2023, which assumes performance
is consistent with annual net product revenues guidance
Expectations for growth assume full access to health care
provider facilities, as a continuation or escalation of access
restrictions or lockdown orders resulting from the ongoing COVID-19
pandemic would adversely affect financial results.
Conference Call and Webcast Details
Xeris will host a conference call and webcast today, Thursday,
March 10, 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/9809/xeris-biopharma-fourth-quarter-2021-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 Thursday, March 24, 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: 872042. 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 our credit agreement with Hayfin, the market and
therapeutic potential of its products and product candidates, the
expected launch by Tetris Pharma of Ogluo in several European
countries in 2022, the expected availability of the Gvoke Kit® in
March 2022, expectations regarding clinical data or results from
planned clinical trials, including from the Phase 1 single
ascending dose study in the third quarter 2022, the timing of
clinical trials, including a new phase 2 clinical program to
further address the management of EIH in people with diabetes who
use insulin expected by the end of 2022, estimates and expectations
regarding potential collaborations, including collaborations on the
XeriJect™ Technology Platform, the timing or likelihood of
regulatory approval and commercialization of its product
candidates, the timing or likelihood of expansion into additional
markets, the timing or likelihood of identifying potential
development and commercialization partnerships, 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 COVID-19 pandemic on Xeris, including impact on access to
health care provider facilities, as a continuation or escalation of
access restrictions or lockdown orders, 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 Quarterly Report on Form 10-Q 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’ plans with respect to
Strongbridge, Xeris’ plans with respect to its products and product
candidates, 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’ most recently filed Quarterly
Report on Form 10-Q 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 December
31,
Twelve Months Ended December
31,
2021
2020
2021
2020
Product revenues, net
$
21,359
$
7,089
$
49,280
$
20,155
Royalty, contract and other revenue
70
83
310
280
Total revenue
21,429
7,172
49,590
20,435
Costs and expenses:
Cost of goods sold, excluding amortization
of intangible assets
4,889
3,407
13,318
9,328
Research and development
10,082
5,110
25,160
20,921
Selling, general and administrative
54,179
17,998
125,718
73,732
Amortization of intangible assets
550
—
550
—
Total costs and expenses
69,700
26,515
164,746
103,981
Loss from operations
(48,271
)
(19,343
)
(115,156
)
(83,546
)
Other income (expense)
(2,519
)
(2,514
)
(7,569
)
(7,704
)
Net loss before benefit from income
taxes
(50,790
)
(21,857
)
(122,725
)
(91,250
)
Benefit from income taxes
—
—
—
110
Net loss
$
(50,790
)
$
(21,857
)
$
(122,725
)
$
(91,140
)
Net loss per common share - basic and
diluted
$
(0.42
)
$
(0.41
)
$
(1.55
)
$
(2.14
)
Weighted average common shares outstanding
- basic and diluted
121,548,995
53,505,197
79,027,062
42,642,901
XERIS BIOPHARMA HOLDINGS,
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
(unaudited)
December 31, 2021
December 31, 2020
Assets
Current assets:
Cash and cash equivalents
$
67,271
$
37,598
Short-term investments
35,162
96,190
Trade accounts receivable, net
17,456
6,875
Inventory
18,118
8,353
Prepaid expenses and other current
assets
4,589
3,196
Total current assets
142,596
152,212
Property and equipment, net
6,627
6,707
Goodwill
22,859
—
Intangible assets, net
131,450
—
Other assets
829
232
Total assets
$
304,361
$
159,151
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
$
8,924
$
3,117
Other accrued liabilities
49,088
15,895
Accrued trade discounts and rebates
15,041
5,984
Accrued returns reserve
4,000
2,889
Other current liabilities
1,987
322
Total current liabilities
79,040
28,207
Long-term debt, net of unamortized debt
issuance costs
88,067
87,021
Contingent value rights
22,531
—
Supply agreement liability, less current
portion
5,991
—
Deferred rent
6,883
6,629
Deferred tax liabilities
4,942
—
Other liabilities
1,676
3,533
Total liabilities
209,130
125,390
Total stockholders’ equity
95,231
33,761
Total liabilities and stockholders’
equity
$
304,361
$
159,151
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220310005334/en/
Investor Contact Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com 312-736-1237
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