Xeris Pharmaceuticals Reports First Quarter 2020 Financial Results and Provides Corporate Updates
Gvoke™ Pre-Filled Syringe (PFS) net sales of
Gvoke HypoPen™ on track for planned launch in
Initiated programs to ensure easier patient access to GVOKE in the midst of the COVID-19 pandemic
Corporate actions taken to conserve cash
Conference call and webcast today at
“Starting in January with the field launch, Gvoke PFS began to see a very positive response from the diabetes community as evidenced by early and steady uptake of prescriptions, units, and units per prescription until the dynamics of the ongoing COVID-19 pandemic slowed our momentum. In response to the pandemic, we quickly moved to a virtual selling model and implemented several programs in an effort to minimize the impact of the crisis on the diabetes patient community and our business,” said
First Quarter 2020 Highlights and Recent Events
Gvoke™
‒ Xeris implemented and recently extended its
‒ In March, Xeris instituted the Xeris Support Program - a HUB powered by ASPN, which offers support for healthcare professionals from benefits verification and prior authorization support (if needed) to free home delivery of Gvoke for the patient.
‒ The Company is on track for its planned launch of Gvoke HypoPen, its liquid stable glucagon in an auto-injector for low blood sugar emergencies, in
‒ In May, the
Pipeline Programs
‒ In January, Xeris reported positive results from the in-clinic portion of its Phase 2 study evaluating the use of its glucagon formulation for the treatment of exercise-induced hypoglycemia (EIH). Results showed that a mini-dose of RTU glucagon was adequate to maintain normal blood glucose levels during prolonged, moderate-to-intense aerobic exercise. The blinded out-patient stage, where subjects will be exercising on their own at home, is currently ongoing with results expected in the second quarter of 2020.
‒ Xeris’ Marketing Authorization Application (MAA) for its ready-to-use liquid stable glucagon for the treatment of severe hypoglycemia in people with diabetes is currently under review by the
‒ Xeris anticipates reporting topline results from the out-patient portion of its Phase 2 study evaluating the use of its glucagon formulation for the treatment of post-bariatric hypoglycemia (PBH) in the second quarter of 2020. The Company previously reported positive topline results from its in-clinic portion.
‒ Xeris completed enrollment in a Phase 2 clinical study to evaluate its investigational ready-to-use, fixed-ratio co-formulation of pramlintide and insulin in people with Type 1 diabetes. Data from this study is anticipated in the second quarter of 2020.
‒ In April, Xeris reported positive topline results from its weight-based dosing study of its investigational ready-to-use diazepam formulation in healthy volunteers. Results showed that Xeris’ intramuscular (IM) diazepam maintains higher concentration over a longer time period versus standard of care. The Company anticipates having a discussion with the FDA to determine a regulatory path forward.
Corporate Highlights
‒ In April, Xeris implemented a deferred compensation plan under which members of our executive management team and board of directors will defer a significant portion of their cash compensation until 2022 to minimize its cash burn.
‒ In April, the Company entered into a
‒ The senior management of Xeris will participate in virtual fireside chats and one-on-one meetings at:
-
RBC Healthcare Conference onMay 20, 2020 -
Jefferies Global Healthcare Conference onJune 2, 2020
First Quarter 2020 Financial Highlights
Net sales: Net sales for Gvoke PFS for the first quarter of 2020 were
Research and development (R&D) expenses: R&D expenses for the first quarter of 2020 were
Selling, general and administrative (SG&A) expenses: SG&A expenses for the first quarter of 2020 were
Net loss: For the first quarter of 2020, Xeris reported a net loss of
Cash position: As of
Conference Call and Webcast Details
About
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
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
(in thousands, except share and per share data; unaudited) | ||||||||
Three Months Ended
|
||||||||
2020 |
2019 |
|||||||
Net sales |
$ |
1,676 |
|
$ |
- |
|
||
Grant and other income |
|
112 |
|
|
248 |
|
||
Cost of goods sold |
|
1,790 |
|
|
- |
|
||
Gross profit (loss) |
|
(2 |
) |
|
248 |
|
||
Operating expenses: | ||||||||
Research and development |
|
6,646 |
|
|
13,167 |
|
||
Selling, general and administrative |
|
21,606 |
|
|
12,518 |
|
||
Total operating expenses |
|
28,252 |
|
|
25,685 |
|
||
Loss from operations |
|
(28,254 |
) |
|
(25,437 |
) |
||
Other income (expense): | ||||||||
Interest and other income |
|
434 |
|
|
671 |
|
||
Interest expense |
|
(1,499 |
) |
|
(1,063 |
) |
||
Change in fair value of warrants |
|
135 |
|
|
552 |
|
||
Total other income (expense) |
|
(930 |
) |
|
160 |
|
||
Net loss before provision for/benefit from income taxes |
|
(29,184 |
) |
|
(25,277 |
) |
||
Provision for/benefit from income taxes |
|
- |
|
|
- |
|
||
Net loss |
$ |
(29,184 |
) |
$ |
(25,277 |
) |
||
Net loss per common share - basic and diluted |
$ |
(0.89 |
) |
$ |
(1.07 |
) |
||
Weighted average common shares outstanding, basic and diluted |
|
32,790,317 |
|
|
23,561,193 |
|
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
(in thousands) | ||||||
(unaudited) | ||||||
Assets | ||||||
Current assets: | ||||||
Cash and cash equivalents |
$ |
39,244 |
$ |
19,519 |
||
Short-term investments |
|
57,698 |
|
56,030 |
||
Trade accounts receivable, net |
|
2,531 |
|
4,693 |
||
Other accounts receivable, net |
|
727 |
|
946 |
||
Inventory |
|
2,166 |
|
2,176 |
||
Prepaid expenses and other current assets |
|
3,154 |
|
4,119 |
||
Total current assets |
|
105,520 |
|
87,483 |
||
Investments |
|
2,992 |
|
13,231 |
||
Property and equipment, net |
|
7,593 |
|
7,853 |
||
Other assets |
|
357 |
|
420 |
||
Total assets |
$ |
116,462 |
$ |
108,987 |
||
Liabilities and Stockholders' Equity | ||||||
Current liabilities: | ||||||
Accounts payable |
$ |
3,840 |
$ |
5,603 |
||
Other accrued liabilities |
|
13,824 |
|
18,119 |
||
Accrued trade discounts and rebates |
|
1,719 |
|
1,375 |
||
Accrued returns reserve |
|
2,336 |
|
1,957 |
||
Other current liabilities |
|
161 |
|
284 |
||
Total current liabilities |
|
21,880 |
|
27,338 |
||
Long-term debt, net of unamortized deferred costs |
|
58,485 |
|
58,305 |
||
Other liabilities |
|
9,028 |
|
8,908 |
||
Total liabilities |
|
89,393 |
|
94,551 |
||
Total stockholders' equity |
|
27,069 |
|
14,436 |
||
Total liabilities and stockholders' equity |
$ |
116,462 |
$ |
108,987 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20200507005140/en/
Investor Contact
Senior Vice President, Investor Relations and Corporate Communications
awey@xerispharma.com
312-736-1237
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