Achieved record net product revenue of $25.3M –
a 15% increase from Q1 ’22, and a 34% increase from same period
prior year on a pro forma basis
Ended Q2 with $111.6M in cash, cash equivalents
and short-term investments
Reaffirms full-year total net product revenue
of $105M-$120M; $50M in synergies by year-end, 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 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 second
quarter and six months ended June 30, 2022 and upcoming events.
“We continue to execute our growth strategy and are pleased to
have posted record net revenue in the second quarter. Demand for
Gvoke HypoPen remains strong and its market share continues to
outpace the overall glucagon market; Keveyis reported its best
quarter to date; and newly launched Recorlev is off to a great
start,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma.
“We continue to drive education and awareness of all three products
and remain confident in the long-term growth opportunity of each.
Our strong performance year-to-date and expectations for the
remainder of the year gives us confidence that we will achieve our
guidance of net product revenue to $105 million to $120 million for
the full year 2022, year-end cash balance of $90 million-$110
million and cash flow breakeven by year-end 2023.”
Second Quarter Highlights and Upcoming
Events
Commercial Products
- Gvoke®: Second quarter 2022 net revenue was $11.5
million as compared to $8.8 million in the second quarter of 2021 –
an increase of approximately 30%. Gvoke prescriptions topped 34,000
for the first time, growing more than 60% 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 July.
- Keveyis®: Second quarter net revenue was $12.8 million –
an increase of 28% compared to the same period in 2021 on a pro
forma basis. The number of patients on Keveyis increased 5% from
the same period in 2021.
- Recorlev®: Second quarter net revenue was $1.0 million.
Xeris launched Recorlev in February 2022 and is experiencing a
steady increase of physicians’ referrals and patients’ starts.
Three Months Ended June
30,
Change
2022
2021
$
%
Product revenue (in thousands):
Gvoke
$
11,479
$
8,835
$
2,644
30%
Keveyis
12,812
—
12,812
nm
Recorlev
969
—
969
nm
Product revenue, net
25,260
8,835
16,425
nm
Royalty, contract and other revenue
46
71
(25
)
-35%
Total revenue
$
25,306
$
8,906
$
16,400
nm
Commercial Partner Update
- Ogluo®: On August 4, 2022, Arecor Therapeutics completed
the acquisition of Tetris Pharma, Xeris’ commercial partner for
Ogluo in the UK and EU. Tetris Pharma is now a subsidiary of Arecor
Therapeutics and continues to commercialize Ogluo in the UK and
EU.
Upcoming Events
- XeriSol® levothyroxine (XP-8121): The third and final
cohort was successfully dosed during the second quarter. The
Company anticipates reporting topline data from a range of doses
and dose proportionality early in the fourth quarter.
- Xeris will participate at the H. C. Wainwright’s 24th Annual
Global Investment Conference, September 12-14, in New York
City.
Second Quarter and Year-to-Date 2022
Financial Results
Gvoke®: Net revenue was $23.9 million for the six months
ended June 30, 2022, a 42% increase compared to prior year. Gvoke
prescriptions for YTD 2022 were over 65,000 TRx’s, growing more
than 73% compared to the same period in 2021. The growth in product
demand was partially offset by a decrease in net pricing.
Keveyis®: Net revenue was $22.1 million for the six
months ended June 30, 2022, a 20% increase from last year on a pro
forma basis. This increase was driven by an 11% increase in sales
volume and an increase in net pricing.
Recorlev®: Net revenue was $1.1 million since its launch
in February 2022.
Six Months Ended June
30,
Change
2022
2021
$
%
Product revenue (in thousands):
Gvoke
$
23,932
$
16,886
$
7,046
42%
Keveyis
22,136
—
22,136
nm
Recorlev
1,102
—
1,102
nm
Product revenue, net
47,170
16,886
30,284
nm
Royalty, contract and other revenue
209
215
(6
)
-3%
Total revenue
$
47,379
$
17,101
$
30,278
nm
Cost of goods sold were $4.8 million and $11.1 million
for the three and six months ended June 30, 2022, respectively, a
$1.4 million and a $5.9 million increase compared to the same
periods last year. The increases were primarily attributable to
increases in sales as well as product mix and increased costs.
Research and development expenses decreased $1.7 million
or 30.9% and increased $0.6 million or 5.9% for the three and six
months ended June 30, 2022, respectively, compared to the same
periods last year. The quarter-to-date decrease was primarily
driven by reduced spend on clinical and product development. The
year-to-date increase was primarily driven by higher personnel
related costs, offset by lower product development costs.
Selling, general and administrative expenses increased
$7.1 million or 27.2% and $23.9 million or 53.1% for the three and
six months ended June 30, 2022, respectively, compared to the same
periods last year. The quarter-to-date increase was mainly
attributable to a $9.7 million of increased personnel-related costs
due to the build out of our sales force to support our three
commercial products. These were offset by $3.8 million decreased
expenses related to the acquisition of Strongbridge. The
year-to-date increase was mainly attributable to a $19.6 million
increase in personnel-related costs due to the buildout of the
sales force to support our three commercial products. We also had a
$2.5 million increase in marketing expenses to primarily support
the launch of Recorlev.
Net Loss for the three months ended June 30, 2022, was
$26.2 million, or $0.19 per share, and a net loss of $59.9 million,
or $0.44 per share, for the six months ended June 30, 2022.
Cash, cash equivalents, and short-term investments at
June 30, 2022 was $111.6 million compared to $102.4 million at
December 31, 2021. Total shares outstanding at July 31, 2022 was
135,957,280.
Conference Call and Webcast Details
Xeris will host a conference call and webcast today, Wednesday,
August 10, 2022, at 8:30 a.m. Eastern Time. To pre-register for the
conference call please use this link:
https://ige.netroadshow.com/registration/q4inc/11152/xeris-biopharma-second-quarter-2022-financial-results-call/.
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, August 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: 562978. In
addition, a live audio of the conference call will be available as
a webcast. 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®, 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 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 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 the "Risk Factors" section of the
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. 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 June
30,
Six Months Ended June
30,
2022
2021
2022
2021
Product revenue, net
$
25,260
$
8,835
$
47,170
$
16,886
Royalty, contract and other revenue
46
71
209
215
Total revenue
25,306
8,906
47,379
17,101
Costs and expenses:
Cost of goods sold, excluding amortization
of intangible assets
4,810
3,383
11,083
5,209
Research and development
3,718
5,383
9,968
9,415
Selling, general and administrative
32,984
25,927
68,897
45,004
Amortization of intangible assets
2,710
—
5,421
—
Total costs and expenses
44,222
34,693
95,369
59,628
Loss from operations
(18,916
)
(25,787
)
(47,990
)
(42,527
)
Other expense
(7,608
)
(1,728
)
(12,656
)
(3,399
)
Net loss before benefit from income
taxes
(26,524
)
(27,515
)
(60,646
)
(45,926
)
Benefit from income taxes
339
—
747
—
Net loss
$
(26,185
)
$
(27,515
)
$
(59,899
)
$
(45,926
)
Net loss per common share - basic and
diluted
$
(0.19
)
$
(0.41
)
$
(0.44
)
$
(0.72
)
Weighted average common shares outstanding
- basic and diluted
135,529,968
66,367,125
135,282,749
63,820,321
XERIS BIOPHARMA HOLDINGS,
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
June 30, 2022
December 31, 2021
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
95,340
$
67,271
Short-term investments
16,213
35,162
Trade accounts receivable, net
25,756
17,456
Inventory
17,887
18,118
Prepaid expenses and other current
assets
6,010
4,589
Total current assets
161,206
142,596
Property and equipment, net
6,170
6,627
Goodwill
22,859
22,859
Intangible assets, net
126,029
131,450
Other assets
2,352
829
Total assets
$
318,616
$
304,361
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
6,631
8,924
Other accrued liabilities
36,945
49,088
Accrued trade discounts and rebates
14,843
15,041
Accrued returns reserve
5,210
4,000
Other current liabilities
916
1,987
Total current liabilities
64,545
79,040
Long-term debt, net of unamortized debt
issuance costs
138,068
88,067
Contingent value rights
30,218
22,531
Supply agreement liability, less current
portion
—
5,991
Deferred rent
6,799
6,883
Deferred tax liabilities
4,195
4,942
Other liabilities
848
1,676
Total liabilities
244,673
209,130
Total stockholders’ equity
73,943
95,231
Total liabilities and stockholders’
equity
$
318,616
$
304,361
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220810005123/en/
Investor Contact Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com 312-736-1237
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