Gvoke® net sales grew 370% quarter over quarter
to $9.4 million driven by launch of Gvoke HypoPen®
Company to host a 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 (RTU)
injectable and infusible drug formulations, today announced
financial results for the third quarter and nine months ended
September 30, 2020, as well as pipeline and corporate
highlights.
“The third quarter results showed the tremendous response from
the diabetes community to the highly anticipated launch of our
Gvoke HypoPen. Across the country, prescriptions have grown
steadily even in the midst of the ongoing pandemic as families have
sought to have the rapid and reliable profile of the Gvoke HypoPen
readily available in the event of a hypoglycemic episode,” said
Paul R. Edick, Xeris’ Chairman and Chief Executive Officer. “As we
look ahead to early next year, we anticipate a European regulatory
decision on our ready-to-use glucagon for severe hypoglycemia and
three FDA meetings for post-bariatric hypoglycemia,
exercise-induced hypoglycemia, and pramlintide-insulin for diabetes
blood sugar control.”
Third Quarter 2020 Highlights and
Recent Events
Gvoke®
- In July, Xeris successfully launched its Gvoke HypoPen, the
first premixed, RTU liquid glucagon auto-injector for very low
blood sugar, with a $0 copay offer for commercially insured
patients, which continues to date.
- At launch and to date, approximately 80% of patients have
unrestricted access to Gvoke across all insurance types.
- Gvoke prescriptions grew approximately 140% quarter over
quarter according to third-party databases. However, the Company
believes that these third-party databases do not accurately capture
underlying product demand and that Gvoke third quarter 2020
prescription growth may be understated. This is likely due to the
estimated nature of prescription growth in these databases,
particularly in the launch phase of new products such as Gvoke
HypoPen.
Pipeline Programs
- In July, Xeris reported additional data from its Phase 1b study
of its investigational RTU diazepam formulation in healthy
volunteers. The Company also announced it has determined a Phase 3
registration study could be initiated based on its positive
interaction with the U.S. Food and Drug Administration (FDA) at its
end-of-Phase 1 meeting. In October, Xeris was granted Fast Track
designation by the FDA for the investigation of XP-0863 (diazepam
non-aqueous injection) for the treatment of acute repetitive
seizures. Xeris’ XP-0863 was previously granted orphan drug
designation for both the treatment of acute repetitive seizures and
the treatment of Dravet syndrome. The Company is currently seeking
a development and commercialization partner to advance the program
to Phase 3.
- Xeris’ Marketing Authorization Application (MAA) for its RTU
liquid stable glucagon for the treatment of severe hypoglycemia in
people with diabetes is currently under review by the European
Medicines Agency (EMA). If approved, the Company could launch its
RTU glucagon in certain European countries in 2021.
- Xeris has requested meetings with the FDA for three of its
pipeline programs: RTU glucagon for the treatment of post-bariatric
hypoglycemia, RTU glucagon for the treatment of exercise-induced
hypoglycemia, and pramlintide-insulin co-formulation in adults with
type 1 diabetes mellitus. Xeris anticipates disclosing each
program’s proposed path forward based on FDA feedback in the first
half of 2021. Based on the outcome of the FDA meeting for its
pramlintide-insulin program, the Company anticipates seeking a
development and commercialization partner to advance this
program.
Upcoming Events
- Xeris’ senior management will participate in the following
upcoming investor conferences:
- Jefferies Virtual London Healthcare Conference on November
17-19, 2020.
- Piper Sandler 32nd Annual Virtual Healthcare Conference on
December 1-3, 2020.
Access to the webcasts of each fireside chat and subsequent
archived presentations will be available on the investor section of
the Company’s website.
Third Quarter and Year-to-Date 2020
Financial Highlights
Net sales: Net sales for Gvoke® for the three- and
nine-months ended September 30, 2020 were $9.4 million and $13.1
million, respectively.
Research and development (R&D) expenses: R&D
expenses for the three- and nine-months ended September 30, 2020
were $3.9 million and $15.8 million, respectively, compared to
$15.5 million and $48.0 million for the same time periods in 2019.
The decreases were primarily driven by decreased pharmaceutical
process development costs, resulting from a reduction of
manufacturing batches and supplies needed for clinical and
preclinical trials and the expenses incurred in the prior year for
the manufacturing of Gvoke prior to commercialization, and
decreased expenses associated with clinical trials.
Selling, general and administrative (SG&A) expenses:
SG&A expenses for the three months ended September 30, 2020
were $16.5 million compared to $14.9 million for the same time
period in 2019. The increase was primarily driven by increased
compensation and related personnel costs, partially offset by
decreases in marketing and selling expenses due to the costs
incurred in the prior year for the initial launch of Gvoke.
SG&A expenses for the nine months ended September 30, 2020 were
$55.7 million compared to $42.4 million for the same time period in
2019. The increase was primarily driven by increased compensation
and related personnel costs due to additional headcount to support
commercialization of Gvoke, increased marketing and selling
expenses, and increased general and administrative costs.
Net loss: For the three months ended September 30, 2020,
Xeris reported a net loss of $16.0 million, or $0.35 per share,
compared to a net loss of $32.8 million, or $1.22 per share, for
the same period in 2019. For the nine months ended September 30,
2020, Xeris reported a net loss of $69.3 million, or $1.78 per
share, compared to a net loss of $92.5 million, or $3.58 per share,
for the same period in 2019.
Cash position: As of September 30, 2020, Xeris reported
total cash, cash equivalents, and investments of $141.7 million,
compared to $88.8 million at December 31, 2019. Total shares
outstanding as of October 31, 2020 were approximately 49.0 million,
including approximately 0.4 million and 2.3 million shares issued
in September and October, respectively, as a result of conversions
of approximately $8.1 million principal amount of our convertible
debt.
Conference Call and Webcast Details
Xeris Pharmaceuticals will host a conference call and webcast
today, Monday, November 9, 2020 at 8:30 a.m. Eastern Time. To
register for this conference call, please use this link
http://www.directeventreg.com/registration/event/5476709. After
registering, a confirmation email will be sent, including dial-in
details and a unique code for entry. To register for the webcast,
visit Xeris’ website at www.xerispharma.com. 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: 5476709.
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 novel technology platforms that enable 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®. Its proprietary XeriSol™ and XeriJect™ formulation
technologies have the potential to offer distinct advantages over
conventional product formulations, including eliminating
reconstitution and refrigeration, enabling long-term,
room-temperature stability, significantly reducing injection
volume, and eliminating the requirement for intravenous (IV)
infusion. With Xeris’ technologies, 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
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 a potential
development and commercialization partnership, 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®, 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 September
30,
Nine Months Ended September
30,
2020
2019
2020
2019
Net sales
$
9,404
$
-
$
13,066
$
-
Grant and other income
44
313
197
858
Cost of goods sold
2,832
-
5,921
-
Gross profit
6,616
313
7,342
858
Operating expenses: Research and development
3,876
15,518
15,811
48,018
Selling, general and administrative
16,484
14,877
55,734
42,419
Total operating expenses
20,360
30,395
71,545
90,437
Loss from operations
(13,744
)
(30,082
)
(64,203
)
(89,579
)
Other income (expense): Interest and other income
232
657
943
2,173
Interest expense
(2,328
)
(3,507
)
(6,069
)
(5,632
)
Change in fair value of warrants
(160
)
96
(64
)
540
Total other income (expense)
(2,256
)
(2,754
)
(5,190
)
(2,919
)
Net loss before benefit from income taxes
(16,000
)
(32,836
)
(69,393
)
(92,498
)
Benefit from income taxes
-
-
110
Net loss
$
(16,000
)
$
(32,836
)
$
(69,283
)
$
(92,498
)
Net loss per common share - basic and diluted
$
(0.35
)
$
(1.22
)
$
(1.78
)
$
(3.58
)
Weighted average common shares outstanding,basic and diluted
46,145,116
26,942,591
38,995,707
25,810,113
XERIS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS (in thousands)
September 30,
2020
December 31,
2019
(unaudited)
Assets Current assets: Cash and cash equivalents
$
37,886
$
19,519
Short-term investments
103,857
56,030
Trade accounts receivable, net
11,928
4,693
Other accounts receivable, net
262
946
Inventory
5,633
2,176
Prepaid expenses and other current assets
3,660
4,119
Total current assets
163,226
87,483
Investments
-
13,231
Property and equipment, net
6,928
7,853
Other assets
232
420
Total assets
$
170,386
$
108,987
Liabilities and Stockholders' Equity Current
liabilities: Accounts payable
$
4,694
$
5,603
Other accrued liabilities
11,822
18,119
Accrued trade discounts and rebates
5,758
1,375
Accrued returns reserve
3,171
1,957
Other current liabilities
1,582
284
Total current liabilities
27,027
27,338
Long-term debt, net of unamortized deferred costs
119,391
58,305
Other liabilities
9,632
8,908
Total liabilities
156,050
94,551
Total stockholders' equity
14,336
14,436
Total liabilities and stockholders' equity
$
170,386
$
108,987
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201109005297/en/
Xeris Investor Contact Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com 312-736-1237
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