Gvoke® net sales of $20.2 million for full-year
2020
Continued Gvoke prescription growth – over 350%
in 2020
Strong cash position of $133.8 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 and
infusible drug formulations, today announced financial results for
the fourth quarter and full-year 2020 and recent highlights.
“Despite the obvious challenges of 2020, I believe it was a very
successful year for Xeris, and in particular, the fourth quarter.
We saw continuous growth in demand for Gvoke throughout the year
with quarter over quarter increases in prescriptions and market
share, which was accelerated by the launch of Gvoke HypoPen in
July, and we did so while operating our commercial organization
virtually for 10 months of the year. We also reported positive
clinical data in several clinical programs, we put more cash on the
balance sheet, and equitized a large portion of our convertible
debt,” said Paul R. Edick, Chairman and CEO. “Looking ahead, we are
poised to steadily grow Gvoke, advance partnership discussions for
Ogluo in ex-US territories, find development and commercialization
partners for select pipeline programs, and advance our technology
platforms, XeriSol™ and XeriJect™, through internal development and
external partnerships.”
Fourth Quarter 2020 Highlights and
Recent Events
Marketed and Approved Products
- Gvoke prescriptions grew approximately 11% quarter over quarter
and over 350% in 2020.
- 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, received a
positive opinion from the European Medicines Agency’s (EMA)
Committee for Medicinal Products for Human Use (CHMP) in December
2020, and the European Commission (EC) granted the marketing
authorisation in February 2021.
- The Company is actively seeking a partner to commercialize
Ogluo in the EU and other regions, with a targeted fourth quarter
2021 launch in select EU countries.
- In December 2020, Xeris entered into an exclusive distribution
agreement with Megapharm Ltd. (“Megapharm”), a leading Israel-based
pharmaceutical company, for the commercialization of Gvoke in
Israel and the Palestinian Authority.
Ready-to-use Glucagon Programs
- Xeris received feedback from FDA in late December and early
January on mini/micro dose development programs in Exercise-Induced
Hypoglycemia (EIH) and Post-Bariatric Hypoglycemia (PBH). The
Company is currently finalizing expectations with the FDA for
registration programs for both, including the study design for
Phase 3 clinical trials, to support indications for its
ready-to-use glucagon in the prevention of EIH and PBH. Based on
the FDA feedback for each program, the Company anticipates
advancing at least one of the glucagon mini/micro dose
programs.
Other XeriSol™ Programs
- Xeris received feedback from the FDA and is finalizing
expectations for a registration program for its XeriSol
pramlintide-insulin co-formulation program, including a study
design for a Phase 3 program. Based on the FDA feedback, the
Company anticipates seeking 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
- To date, a total principal amount of $39.1 million of
Convertible Notes converted into 13,171,791 shares of the Company’s
common stock. As of December 31, 2020, the outstanding balance of
Convertible Notes was $47.2 million.
Fourth Quarter and Full-Year 2020 Financial
Highlights
Net sales: Net sales for Gvoke for the fourth quarter of
2020 and full-year 2020 were $7.1 million and $20.2 million,
respectively. Net sales for Gvoke pre-filled syringe (PFS) for both
the fourth quarter of 2019 and full year 2019 were $1.6
million.
Cost of goods sold: Cost of goods sold for the fourth
quarter of 2020 and full-year 2020 were $3.4 million and $9.3
million, respectively. Cost of goods sold for both the fourth
quarter of 2019 and full year 2019 were $1.6 million.
Research and development (R&D) expenses: R&D
expenses for the fourth quarter and full-year 2020 were $5.1
million and $20.9 million, respectively, compared to $12.4 million
and $60.4 million for the same time periods in 2019.
Selling, general and administrative (SG&A) expenses:
SG&A expenses for the fourth quarter and full year ended
December 31, 2020 were $18.0 million and $73.7 million,
respectively, compared to $20.6 million and $63.1 million for the
same time periods in 2019.
Net loss: For the fourth quarter ended December 31, 2020,
Xeris reported a net loss of $21.9 million, or $0.41 per share,
compared to a net loss of $33.1 million, or $1.23 per share, for
the same period in 2019. For the full year ended December 31, 2020,
Xeris reported a net loss of $91.1 million, or $2.14 per share,
compared to a net loss of $125.6 million, or $4.81 per share, for
the same period in 2019.
Cash position: As of December 31, 2020, Xeris reported
total cash, cash equivalents, and investments of $133.8 million,
compared to $88.8 million at December 31, 2019. Total shares
outstanding as of February 28, 2021 is 59,764,999.
Conference Call and Webcast Details
Xeris Pharmaceuticals will host a conference call and webcast
today, Tuesday, March 9, 2021 at 8:30 a.m. Eastern Time. To
register for this conference call, please use this link:
http://www.directeventreg.com/registration/event/7648057. 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: 7648057.
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.
CONSOLIDATED STATEMENTS OF
OPERATIONS
(in thousands, except share and
per share data)
Three Months Ended December
31,
Twelve Months Ended December
31,
2020
2019
2020
2019
Net sales
$
7,089
$
1,627
$
20,155
$
1,627
Grant and other income
83
237
280
1,095
Cost of goods sold
3,407
1,603
9,328
1,603
Gross profit
3,765
261
11,107
1,119
Operating expenses: Research and development
5,110
12,420
20,921
60,438
Selling, general and administrative
17,998
20,642
73,732
63,061
Total operating expenses
23,108
33,062
94,653
123,499
Loss from operations
(19,343
)
(32,801
)
(83,546
)
(122,380
)
Other income (expense): Interest and other income
2,022
640
2,965
2,813
Interest expense
(4,591
)
(1,531
)
(10,660
)
(7,163
)
Change in fair value of warrants
55
152
(9
)
692
Total other income (expense)
(2,514
)
(739
)
(7,704
)
(3,658
)
Net loss before benefit from income taxes
(21,857
)
(33,540
)
(91,250
)
(126,038
)
Benefit from income taxes
-
458
110
458
Net loss
$
(21,857
)
$
(33,082
)
$
(91,140
)
$
(125,580
)
Net loss per common share - basic and diluted
$
(0.41
)
$
(1.23
)
$
(2.14
)
$
(4.81
)
Weighted average common shares outstanding,basic and diluted
53,505,197
27,001,059
42,642,901
26,110,297
XERIS PHARMACEUTICALS,
INC.
CONSOLIDATED BALANCE
SHEETS
(in thousands)
December 31, 2020
December 31, 2019
Assets Current assets: Cash and cash equivalents
$
37,598
$
19,519
Short-term investments
96,190
56,030
Trade accounts receivable, net
6,875
4,693
Inventory
8,353
2,176
Prepaid expenses and other current assets
3,196
5,065
Total current assets
152,212
87,483
Investments
-
13,231
Property and equipment, net
6,707
7,853
Other assets
232
420
Total assets
$
159,151
$
108,987
Liabilities and Stockholders' Equity Current
liabilities: Accounts payable
$
3,117
$
5,603
Other accrued liabilities
15,895
18,119
Accrued trade discounts and rebates
5,984
1,375
Accrued returns reserve
2,889
1,957
Other current liabilities
322
284
Total current liabilities
28,207
27,338
Long-term debt, net of unamortized deferred issuance costs
87,021
58,305
Deferred rent
6,629
7,076
Other liabilities
3,533
1,832
Total liabilities
125,390
94,551
Total stockholders' equity
33,761
14,436
Total liabilities and stockholders' equity
$
159,151
$
108,987
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210309005183/en/
Investor Contact Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com 312-736-1237
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