Gvoke® quarterly net sales of $8.1 million
Record quarterly Gvoke prescription volume
Strong cash position of $136.0 million
Conference call and webcast today at 8:30 a.m.
ET
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty
pharmaceutical company leveraging its novel formulation technology
platforms to develop and commercialize ready-to-use injectable drug
formulations, today announced financial results for the first
quarter 2021 and recent highlights.
“We are very pleased with our steady, consistently growing
financial performance in the first quarter notwithstanding the
continued challenges created by the global pandemic. Demand for
Gvoke grew despite a suppressed market, Ogluo received approval in
the EU and UK, and our discussions with the FDA have provided
clarity for our proposed Phase 3 study designs,” said Paul R.
Edick, Chairman and CEO of Xeris. “Our momentum is continuing into
the second quarter, and we are encouraged by what appears to be
more stability in the overall endocrinology market and the glucagon
market specifically.”
First Quarter 2021 Highlights and
Recent Events
Marketed and Approved Products
- In the first quarter, Gvoke prescriptions topped 16,000 for the
first time, growing more than 3% from the prior quarter (despite a
decline in the glucagon market) and over 400% compared to the same
period in 2020. Gvoke’s NRx share of the retail glucagon market
grew to 14% during the first quarter.
- In February, Ogluo®, Xeris’ ready-to-use, room-temperature
stable liquid glucagon for the treatment of severe hypoglycemia in
pediatric and adult patients with diabetes ages 2 years and above,
was granted marketing authorisation by the European Commission
(EC). In April, the United Kingdom’s Medicines and Healthcare
Regulatory Agency (MHRA) also approved Ogluo.
- The Company is actively talking to potential partners to
commercialize Ogluo in the EU and other regions, with a targeted
fourth quarter 2021 launch in select EU countries.
Ready-to-use Glucagon Programs
- In the first quarter, Xeris received initial feedback from FDA
on its micro-dose development program in Exercise-Induced
Hypoglycemia (EIH). In May, the Company received additional written
feedback requiring a more extensive clinical program to advance
EIH. Due to the design and scope that the FDA is requiring, Xeris
will re-evaluate the pathway and target indication.
- Xeris received initial feedback from the FDA on its mini-dose
development program in Post-Bariatric Hypoglycemia (PBH).
Subsequently, upon the advice of the FDA, Xeris has submitted a
Type C meeting request for further clarification of its proposed
study design.
Other Pipeline Programs
- Xeris received initial feedback from the FDA for a registration
program for its XeriSol pramlintide-insulin co-formulation program,
including a study design for a Phase 3 program. Subsequently, the
Company submitted a follow-up meeting request for further
clarification and anticipates a response in the third quarter.
Based on the FDA feedback, the Company plans to seek a development
and commercialization partner to advance the program.
- Xeris is seeking a partner to further develop and commercialize
its XeriSol diazepam program.
Corporate Highlights
- In March, through a registered direct offering, Xeris issued
6,553,398 shares of common stock to funds managed by Deerfield
Management Company, L.P., which are existing investors in the
Company, at a purchase price of $4.12 per share, resulting in gross
proceeds of $27.0 million.
- In May, the Company amended its existing loan agreement with
Oxford Finance and Silicon Valley Bank to extend the interest-only
period up to 12 months upon achievement of certain revenue
targets.
- Senior members of the management team will participate in the
following upcoming virtual events: ‒ The diaTribe Foundation
Musings: Taking the Fear out of Hypoglycemia: Next-Generation
Glucagon on May 13, 2021 ‒ RBC Capital Markets Global Healthcare
Conference on May 18-19, 2021 ‒ Jefferies Global Healthcare
Conference on June 1-4, 2021
First Quarter 2021 Financial Highlights
Net sales: Net sales for Gvoke for the first quarter 2021
were $8.1 million. Net sales for Gvoke pre-filled syringe (PFS) for
the first quarter 2020 were $1.7 million.
Cost of goods sold: Cost of goods sold was $1.8 million
for the first quarter 2021. Cost of goods sold for the first
quarter 2020 was also $1.8 million, which included $1.2 million
related to the establishment of a reserve for excess and obsolete
inventory.
Research and development (R&D) expenses: R&D
expenses for the first quarter 2021 were $4.0 million compared to
$6.6 million for the first quarter 2020. The decrease was primarily
driven by declines in expenses associated with our clinical trials
and pharmaceutical process development.
Selling, general and administrative (SG&A) expenses:
SG&A expenses for the first quarter 2021 were $19.1 million
compared to $21.6 million for the first quarter 2020. The decrease
was primarily driven by a decrease in advertising and fewer
conferences and meetings as a result of the COVID-19 pandemic,
partially offset by increases in personnel-related costs driven by
additional headcount.
Net loss: For the first quarter 2021, Xeris reported a
net loss of $18.4 million, or $0.30 per share, compared to a net
loss of $29.2 million, or $0.89 per share, for the first quarter
2020.
Cash position: As of March 31, 2021, Xeris reported total
cash, cash equivalents, and investments of $135.9 million, compared
to $133.8 million at December 31, 2020. Total shares outstanding as
of March 31, 2021 is 66,333,456.
Conference Call and Webcast Details
Xeris Pharmaceuticals will host a conference call and webcast
today, Thursday, May 13, 2021 at 8:30 a.m. Eastern Time. To
register for this conference call, please use this link:
http://www.directeventreg.com/registration/event/8668322. After
registering, a confirmation email will be sent, including dial-in
details and a unique code for entry. The Company recommends
registering at minimum ten minutes prior to the start of the call.
Following the conference call, a replay will be available at (800)
585-8367 or (416) 621-4642 Conference ID: 8668322.
About Xeris Pharmaceuticals, Inc.
Xeris (Nasdaq: XERS) is a specialty pharmaceutical company
delivering innovative solutions to simplify the experience of
administering important therapies that people rely on every day
around the world.
With a novel technology platform that enables ready-to-use,
room-temperature stable formulations of injectable and infusible
therapies, the company is advancing a portfolio of solutions in
various therapeutic categories, including its first commercial
product, Gvoke® in the U.S. Its proprietary XeriSol™ and XeriJect™
formulation technologies have the potential to offer distinct
advantages over conventional product formulations, including
eliminating the need for reconstitution, enabling long-term,
room-temperature stability, significantly reducing injection
volume, and eliminating the requirement for intravenous (IV)
infusion. With Xeris’ technology, new product formulations are
designed to be easier to use by patients, caregivers, and health
practitioners and help reduce costs for payers and the healthcare
system.
Xeris 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 Pharmaceuticals, 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, 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.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including, without limitation, the impact of COVID-19 on
its business operations, its reliance on third-party suppliers for
Gvoke® and Ogluo®, the regulatory approval of its product
candidates, its ability to market and sell its products, if
approved, and other factors discussed in the "Risk Factors" section
of the most recently filed Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission, as well as discussions of
potential risks, uncertainties, and other important factors in
Xeris’ subsequent filings with the Securities and Exchange
Commission. Any forward-looking statements contained in this press
release speak only as of the date hereof, and Xeris expressly
disclaims any obligation to update any forward-looking statements,
whether as a result of new information, future events or
otherwise.
The Company intends to use the investor relations portion of its
website as a means of disclosing material non-public information
and for complying with disclosure obligations under Regulation
FD.
XERIS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (in thousands, except share and per
share data, unaudited)
Three Months Ended
March 31,
2021
2020
Net sales
$
8,051
$
1,676
Grant and other income
144
112
Cost of goods sold
1,826
1,790
Gross profit
6,369
(2
)
Operating expenses: Research and development
4,032
6,646
Selling, general and administrative
19,077
21,606
Total operating expenses
23,109
28,252
Loss from operations
(16,740
)
(28,254
)
Other income (expense): Interest and other income
100
434
Interest expense
(1,791
)
(1,499
)
Change in fair value of warrants
20
135
Total other income (expense)
(1,671
)
(930
)
Net loss before benefit from income taxes
(18,411
)
(29,184
)
Benefit from income taxes
-
-
Net loss
$
(18,411
)
$
(29,184
)
Net loss per common share - basic and diluted
$
(0.30
)
$
(0.89
)
Weighted average common shares outstanding, basic and diluted
61,245,220
32,790,317
XERIS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS (in thousands)
March 31, 2021
December 31, 2020 (unaudited)
Assets Current
assets: Cash and cash equivalents
$
66,604
$
37,598
Short-term investments
69,290
96,190
Trade accounts receivable, net
8,938
6,875
Inventory
12,496
8,353
Prepaid expenses and other current assets
3,298
3,196
Total current assets
160,626
152,212
Property and equipment, net
6,799
6,707
Other assets
212
232
Total assets
$
167,637
$
159,151
Liabilities and Stockholders' Equity Current
liabilities: Accounts payable
$
4,768
$
3,117
Other accrued liabilities
13,904
15,895
Accrued trade discounts and rebates
5,719
5,984
Accrued returns reserve
2,619
2,889
Other current liabilities
414
322
Total current liabilities
27,424
28,207
Long-term debt, net of unamortized deferred issuance costs
87,272
87,021
Long-term deferred rent
6,692
6,629
Other liabilities
1,862
3,533
Total liabilities
123,250
125,390
Total stockholders' equity
44,387
33,761
Total liabilities and stockholders' equity
$
167,637
$
159,151
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210513005414/en/
Investor Contact Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com 312-736-1237
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