Xeris Pharmaceuticals Reports Second Quarter 2020 Financial Results and Corporate Highlights
Gvoke® net sales were
Gvoke PFS prescriptions grew 72% quarter over quarter
July availability of Gvoke HypoPen™ accelerates prescription growth
June capital raise significantly strengthens balance sheet
Company to host a conference call and webcast today at
“Our strong performance this quarter reflects Xeris’ dedication to the communities we serve, despite numerous pandemic-related constraints. Prescriptions for Gvoke have continued to rise steadily, illustrating its utility for individuals with diabetes and their families, particularly in the current environment. We've taken thoughtful approaches to maintain continuity and deliver on our mission, including intense preparations for the launch of the Gvoke HypoPen, which was announced just weeks ago, positive results from four of our clinical development programs, and a successful capital raise that strengthens our balance sheet," said
Second Quarter 2020 Highlights and Recent Events
Gvoke®
-
In May, Xeris extended its
$0 copay for Gvoke PFS to relieve the financial burden for commercially insured patients during the COVID-19 pandemic. - Gvoke PFS prescriptions grew 72% quarter over quarter.
-
In July, Xeris launched its Gvoke HypoPen™ and implemented a
$0 copay offer for commercially insured patients. - Currently, approximately 80% of patients have unrestricted access to Gvoke (PFS and HypoPen) across all payers.
Pipeline Programs
-
In July, Xeris reported additional data from its Phase 1b study of its investigational ready-to-use 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. Preliminary topline data from this study were announced inApril 2020 . - In June, Xeris reported positive topline results from 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. Results from this proof-of-concept study demonstrate that Xeris’ pramlintide-insulin co-formulation safely reduced postprandial glycemic excursions and has the potential to significantly improve the management of glycemic conditions of people with diabetes.
- In June, Xeris reported positive results from the out-patient portion of its Phase 2 study evaluating the use of its glucagon formulation for the treatment of exercise-induced hypoglycemia (EIH). Results show a pre-treatment with a micro dose (150 µg) of Gvoke RTU Micro significantly prevented EIH during prolonged, moderate-to-high intensity aerobic exercise in a real-world setting with or without adjustment to insulin.
- In May, Xeris reported positive 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). Results further established the safety profile and utility for mini dosing RTU glucagon in a real-world setting. The Company previously reported positive topline results from its in-clinic portion.
-
In May, Xeris announced an exclusive agreement with Clinigen Group plc to manage the supply and distribution of Gvoke outside of
the United States where Gvoke is not currently licensed. -
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
European Medicines Agency (EMA). If approved, the Company could launch its RTU glucagon in certain European countries in 2021.
Corporate Highlights
-
The Company raised
$109.4 million in gross proceeds from the concurrentJune 2020 offerings of 5.00% convertible senior notes and common stock (including$14.3 million in gross proceeds from the exercise of the underwriters’ over-allotment options inJuly 2020 ). -
In June, with the use of proceeds from the concurrent convertible notes and equity offerings, the Company repaid the full
$4.2 million outstanding under its Paycheck Protection Program loan and prepaid$20.0 million under its loan facility withOxford Finance andSilicon Valley Bank . In conjunction with the loan prepayment, the facility’s maturity date was extended by one year and the interest-only period was extended by nine months, with the potential for an additional nine months upon achievement of a certain revenue milestone.
Second Quarter and Year-to-Date 2020 Financial Highlights
Net sales: Net sales for Gvoke® for the three- and six-months ending
Research and development (R&D) expenses: R&D expenses for the three- and six-months ending
Selling, general and administrative (SG&A) expenses: SG&A expenses for the three months ending
Net loss: For the three months ended
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 |
Six Months Ended |
|||||||||||||||
2020 |
2019 |
2020 |
2019 |
|||||||||||||
Net sales |
$ |
1,986 |
|
$ |
- |
|
$ |
3,662 |
|
$ |
- |
|
||||
Grant and other income |
|
41 |
|
|
297 |
|
|
153 |
|
|
545 |
|
||||
Cost of goods sold |
|
1,299 |
|
|
- |
|
|
3,089 |
|
|
- |
|
||||
Gross profit |
|
728 |
|
|
297 |
|
|
726 |
|
|
545 |
|
||||
Operating expenses: | ||||||||||||||||
Research and development |
|
5,289 |
|
|
19,333 |
|
|
11,935 |
|
|
32,500 |
|
||||
Selling, general and administrative |
|
17,644 |
|
|
15,024 |
|
|
39,250 |
|
|
27,542 |
|
||||
Total operating expenses |
|
22,933 |
|
|
34,357 |
|
|
51,185 |
|
|
60,042 |
|
||||
Loss from operations |
|
(22,205 |
) |
|
(34,060 |
) |
|
(50,459 |
) |
|
(59,497 |
) |
||||
Other income (expense): | ||||||||||||||||
Interest and other income |
|
277 |
|
|
845 |
|
|
711 |
|
|
1,516 |
|
||||
Interest expense |
|
(2,242 |
) |
|
(1,062 |
) |
|
(3,741 |
) |
|
(2,125 |
) |
||||
Change in fair value of warrants |
|
(39 |
) |
|
(108 |
) |
|
96 |
|
|
444 |
|
||||
Total other income (expense) |
|
(2,004 |
) |
|
(325 |
) |
|
(2,934 |
) |
|
(165 |
) |
||||
Net loss before benefit from income taxes |
|
(24,209 |
) |
|
(34,385 |
) |
|
(53,393 |
) |
|
(59,662 |
) |
||||
Benefit from income taxes |
|
110 |
|
|
- |
|
|
110 |
|
|
- |
|
||||
Net loss |
$ |
(24,099 |
) |
$ |
(34,385 |
) |
$ |
(53,283 |
) |
$ |
(59,662 |
) |
||||
Net loss per common share - basic and diluted |
$ |
(0.63 |
) |
$ |
(1.28 |
) |
$ |
(1.51 |
) |
$ |
(2.36 |
) |
||||
Weighted average common shares outstanding, basic and diluted |
|
37,973,123 |
|
|
26,889,398 |
|
|
35,381,720 |
|
|
25,234,489 |
|
||||
|
||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||
(in thousands) |
||||||
|
|
|||||
(unaudited) | ||||||
Assets | ||||||
Current assets: | ||||||
Cash and cash equivalents |
$ |
102,465 |
$ |
19,519 |
||
Short-term investments |
|
41,530 |
|
56,030 |
||
Trade accounts receivable, net |
|
3,171 |
|
4,693 |
||
Other accounts receivable, net |
|
701 |
|
946 |
||
Inventory |
|
4,824 |
|
2,176 |
||
Prepaid expenses and other current assets |
|
3,672 |
|
4,119 |
||
Total current assets |
|
156,363 |
|
87,483 |
||
Investments |
|
1,790 |
|
13,231 |
||
Property and equipment, net |
|
7,387 |
|
7,853 |
||
Other assets |
|
270 |
|
420 |
||
Total assets |
$ |
165,810 |
$ |
108,987 |
||
Liabilities and Stockholders' Equity | ||||||
Current liabilities: | ||||||
Accounts payable |
$ |
4,440 |
$ |
5,603 |
||
Other accrued liabilities |
|
13,240 |
|
18,119 |
||
Accrued trade discounts and rebates |
|
2,412 |
|
1,375 |
||
Accrued returns reserve |
|
2,477 |
|
1,957 |
||
Other current liabilities |
|
218 |
|
284 |
||
Total current liabilities |
|
22,787 |
|
27,338 |
||
Long-term debt, net of unamortized debt issuance costs |
|
109,476 |
|
58,305 |
||
Other liabilities |
|
9,166 |
|
8,908 |
||
Total liabilities |
|
141,429 |
|
94,551 |
||
Total stockholders' equity |
|
24,381 |
|
14,436 |
||
Total liabilities and stockholders' equity |
$ |
165,810 |
$ |
108,987 |
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20200810005176/en/
Xeris Investor Contact
Senior Vice President, Investor Relations and Corporate Communications
awey@xerispharma.com
312-736-1237
Source: