Acquisition of Strongbridge Biopharma closed
October 5, 2021; integration complete
Q3 pro forma net sales of $22.5M: Gvoke® and
Keveyis® $11.0M and $11.5M, respectively
Gvoke and Keveyis net sales grew 19% compared
to Q2 2021 and combined are on track to achieve $76M to $80M full
year 2021 net sales
On track to realize $50M in synergies;
anticipates year-end cash, cash equivalents, and investments of
approximately $100M
Achieved 12-month interest-only extension on
Oxford/SVB debt facility, deferring approximately $17M in principal
repayment to 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 third quarter and first nine months ended
September 30, 2021, and recent highlights, including the completion
of the Strongbridge Biopharma plc acquisition on October 5,
2021.
“Continued strong demand for both Gvoke and Keveyis resulted in
outstanding growth in third quarter, recording pro forma net sales
of $22.5 million. Our two commercial brands are now on track to
achieve a combined $76-80 million in full year revenue,” said Paul
R. Edick, Chairman and CEO of Xeris Biopharma. "Since the closing
of the Strongbridge acquisition in early October, we have completed
integration of the operations. We are operating as one company and
are on track to realize $50 million in synergies, while at the same
time intensely preparing for the potential commercial launch of
Recorlev. We are in a strong cash position to drive continued
growth of Gvoke and Keveyis, prepare for and launch Recorlev in Q1
2022, if approved, and continue to advance our pipeline
products.”
Third Quarter 2021 Highlights and
Recent Events
Marketed Products
- Gvoke: Third quarter 2021 prescriptions topped 27,000 for the
first time, growing more than 28% from the prior quarter and 95%
compared to the same period in 2020. Gvoke’s NRx share of the
retail glucagon market grew to approximately 18% during the third
quarter. Gvoke YTD revenue more than doubled to $27.9 million when
compared to the same nine-month period in 2020. Also in the third
quarter, the FDA approved the sNDA for the Gvoke Kit, which will be
available in Q1 2022, as well as an extended room temperature
shelf-life of the Gvoke 1mg HypoPen and PFS from 24 months to 30
months.
- Keveyis®: Third quarter 2021 net sales of $11.5 million
represent a 42% increase in revenue compared to $8.1 million during
third quarter 2020. YTD 2021 net sales of $29.9 million represent a
33% increase versus same period last year. Xeris anticipates full
year 2021 net sales for Keveyis to be in the range of $38 to $40
million, exceeding previously given full year estimates of $34 to
$36 million.
- Ogluo®: In July, Xeris entered into an exclusive agreement with
Tetris Pharma to commercialize Ogluo® in the European Economic
Area, United Kingdom, and Switzerland. Tetris is on track to launch
Ogluo in the UK before year-end 2021.
Pipeline Programs
- Recorlev®: The NDA is under review with the FDA for the
treatment of endogenous Cushing’s syndrome with a PDUFA goal date
of January 1, 2022. Assuming approval, Xeris anticipates launching
Recorlev in the first quarter of 2022.
- Exercise-induced Hypoglycemia (EIH): Xeris plans to submit an
IND in the first half of 2022, and upon clearance, expects to
continue to generate more clinical data addressing the management
of EIH in 2022.
- Levothyroxine: Xeris has successfully enrolled all participants
in a Phase 1 study of levothyroxine (XP-8121) to evaluate the
pharmacokinetics, safety and tolerability, and potential for weekly
dosing of the investigational, novel, subcutaneous (SC) injection
for the treatment of hypothyroidism.
- XeriJect™ Technology Platform Collaborations: In October, Xeris
announced a collaboration agreement with Merck, with an option to
license Xeris’ suspension-based formulation technology, XeriJect™,
for use with undisclosed monoclonal antibodies (mAbs) for the
purpose of engineering ultra-high concentration, ready-to-use
formulations.
Corporate & Financial Highlights
- Xeris ended with a cash position of $93 million as of September
30, 2021. and received an additional $38 million from Strongbridge
at close of acquisition putting Xeris in a healthy cash position.
Xeris anticipates year-end cash, cash equivalents, and investments
of approximately $100 million, which is after incurring
approximately $40 million in acquisition-related one-time costs and
debt extinguishment by Strongbridge. The Company believes that its
cash resources are sufficient to sustain operations through at
least the end of 2022.
- Due to the continued strong performance of both Gvoke and
Keveyis, Xeris has achieved a full 12-month interest-only extension
on our debt facility with Oxford and Silicon Valley Bank, which
pushes out principal repayment to start Q1 2023 and avoids
approximately $17.4 million in principal payments in 2022.
- In the third quarter, Strongbridge and its existing lender,
Avenue Venture Opportunities Fund, LP (“Avenue”) entered into an
amendment to its existing term loan agreement, whereby $10.0
million of the $20.0 million aggregate principal amount outstanding
would automatically convert into Strongbridge ordinary shares
immediately prior to the completion of the acquisition of
Strongbridge by Xeris. The remaining Avenue aggregate principal
amount of $10.0 million was repaid in full by Strongbridge upon the
completion of the acquisition of Strongbridge by Xeris.
- In conjunction with the close of the Strongbridge acquisition,
John H. Johnson and Garheng Kong, M.D., PhD, MBA, joined the Board
of Directors of Xeris Biopharma.
- Senior Management will participate in the upcoming investor
conferences: ‒ Jefferies London Healthcare Conference, November
18-19, 2021 ‒ Piper Sandler 33rd Annual Healthcare Conference,
November 30-December 2, 2021 ‒ H.C. Wainwright BioConnect
Conference 2022, January 10-13, 2022
Third Quarter and Year-to-Date 2021 Financial Highlights
(Xeris Pharmaceuticals, Inc. stand-alone without impact of
Strongbridge acquisition)
Net sales: Net sales for Gvoke HypoPen® and Gvoke
pre-filled syringe for the three- and nine-month periods ending
September 30, 2021 were $11.0 million and $27.9 million,
respectively. Net sales for Gvoke, comprised primarily of Gvoke
PFS, for the same periods ending September 30, 2020 were $9.4
million and $13.1 million, respectively. The increases in net sales
for both periods were primarily due to increased demand for
Gvoke.
Cost of goods sold: Cost of goods sold was $3.2 million
and $8.4 million for the three and nine months ended September 30,
2021.
Research and development (R&D) expenses: R&D
expenses was $5.7 million and $15.1 million for the three and nine
months ended September 30, 2021.
Selling, general and administrative (SG&A) expenses:
SG&A expenses for the three and nine months ended September 30,
2021 were $26.5 million and $71.5 million. These figures include
transaction-related expenses of $2.3 million and $6.2 million for
the three and nine months ended September 30, 2021,
respectively.
Net loss: For the three months ended September 30, 2021,
Xeris reported a net loss of $26.0 million, or $0.39 per share, and
a net loss of $71.9 million, or $1.11 per share, for the nine
months ended September 30, 2021. The net loss and per share figures
include transaction-related expenses of $2.3 million (or $0.03 per
share) and $6.2 million (or $0.10 per share) for the three and nine
months ended September 30, 2021, respectively.
Cash position: As of September 30, 2021, Xeris reported
total cash, cash equivalents, and investments of $93.0 million,
compared to $133.8 million at December 31, 2020. Total shares
outstanding as of October 31, 2021 is 124,708,935.
Conference Call and Webcast Details
Xeris will host a conference call and webcast today, Wednesday,
November 10, 2021, at 8:30 a.m. Eastern Time. To register for this
conference call, please use this link:
https://www.incommglobalevents.com/registration/q4inc/9056/xeris-biopharma-third-quarter-2021-financial-results/.
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, November 24, 2021, at 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: 508975
About Xeris Biopharma
Xeris (Nasdaq: XERS), is a biopharmaceutical company developing
and commercializing unique therapies for patient populations in
endocrinology, neurology, and gastroenterology. Xeris has two
commercially available products, Gvoke®, a ready-to-use liquid
glucagon for the treatment of severe hypoglycemia and Keveyis®, the
first and only FDA-approved therapy for primary periodic paralysis.
In addition to Recorlev®, which is filed and under review by the
FDA, 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 market and therapeutic potential of its
products and product candidates, expectations regarding clinical
data or results from planned clinical trials, estimates and
projections about the potential benefits of the Strongbridge
Biopharma acquisition, the future performance of the combined
company and estimated synergies, estimates and expectations
regarding potential collaborations, 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 (if
approved), the regulatory approval of its product candidates, its
ability to market and sell its products, failure to realize the
expected benefits of the acquisition, failure to promptly and
effectively integrate Strongbridge’s businesses, general economic
and business conditions that affect the combined company following
the consummation of the acquisition, the impact of the COVID-19
pandemic on the combined company following the consummation of the
transaction, 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’ 2020
Annual Report on Form 10-K, which has been filed with the SEC and
other important factors in Xeris’ subsequent filings with the SEC,
the contents of which are not incorporated by reference into, nor
do they form part of, this communication. Additional information
about economic, competitive, governmental, technological, and other
factors that may affect Strongbridge is set forth in Item 1A, “Risk
Factors,” in Strongbridge’s 2020 Annual Report on Form 10-K, which
has been 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 PHARMACEUTICALS,
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,
2021
2020
2021
2020
Net sales
$
11,035
$
9,404
$
27,921
$
13,066
Grant and other income
25
44
240
197
Cost of goods sold
3,220
2,832
8,429
5,921
Gross profit
7,840
6,616
19,732
7,342
Operating expenses:
Research and development
5,663
3,876
15,078
15,811
Selling, general and administrative
26,535
16,484
71,539
55,734
Total operating expenses
32,198
20,360
86,617
71,545
Loss from operations
(24,358
)
(13,744
)
(66,885
)
(64,203
)
Other income (expense):
Interest and other income
66
232
243
943
Interest expense
(1,798
)
(2,328
)
(5,384
)
(6,069
)
Change in fair value of warrants
81
(160
)
91
(64
)
Total other income (expense)
(1,651
)
(2,256
)
(5,050
)
(5,190
)
Net loss before benefit from income
taxes
(26,009
)
(16,000
)
(71,935
)
(69,393
)
Benefit from income taxes
—
—
—
110
Net loss
$
(26,009
)
$
(16,000
)
$
(71,935
)
$
(69,283
)
Other comprehensive loss, net of tax:
Unrealized gains (losses) on
investments
(5
)
(125
)
(34
)
1
Foreign currency translation
adjustments
(1
)
17
2
12
Comprehensive loss
$
(26,015
)
$
(16,108
)
$
(71,967
)
$
(69,270
)
Net loss per common share - basic and
diluted
$
(0.39
)
$
(0.35
)
$
(1.11
)
$
(1.78
)
Weighted average common shares outstanding
- basic and diluted
66,497,593
46,145,116
64,722,552
38,995,707
XERIS PHARMACEUTICALS,
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
September 30, 2021
December 31, 2020
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
59,492
$
37,598
Short-term investments
33,491
96,190
Trade accounts receivable, net
13,561
6,875
Inventory
14,241
8,353
Prepaid expenses and other current
assets
3,582
3,196
Total current assets
124,367
152,212
Property and equipment, net
6,682
6,707
Other assets
211
232
Total assets
$
131,260
$
159,151
Liabilities and Stockholders’ (Deficit)
Equity
Current liabilities:
Accounts payable
$
4,290
$
3,117
Other accrued liabilities
22,957
15,895
Accrued trade discounts and rebates
6,782
5,984
Accrued returns reserve
3,161
2,889
Other current liabilities
95
322
Total current liabilities
37,285
28,207
Long-term debt, net of unamortized debt
issuance costs
87,713
87,021
Deferred rent
6,826
6,629
Other liabilities
1,897
3,533
Total liabilities
133,721
125,390
Total stockholders’ (deficit) equity
(2,461
)
33,761
Total liabilities and stockholders’
(deficit) equity
$
131,260
$
159,151
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211110005368/en/
Allison Wey Senior Vice President, Investor Relations and
Corporate Communications awey@xerispharma.com 312-736-1237
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