Xeris Pharmaceuticals Reports First Quarter 2021 Financial Results and Recent Highlights
Gvoke® quarterly net sales of
Record quarterly Gvoke prescription volume
Strong cash position of
Conference call and webcast today at
“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
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’sMedicines 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 andSilicon 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 onMay 13, 2021
‒RBC Capital Markets Global Healthcare Conference onMay 18-19, 2021
‒Jefferies Global Healthcare Conference onJune 1-4, 2021
First Quarter 2021 Financial Highlights
Net sales: Net sales for Gvoke for the first quarter 2021 were
Cost of goods sold: Cost of goods sold was
Research and development (R&D) expenses: R&D expenses for the first quarter 2021 were
Selling, general and administrative (SG&A) expenses: SG&A expenses for the first quarter 2021 were
Net loss: For the first quarter 2021, 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 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
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
|
||||||||
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 |
|
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
(in thousands) | ||||||
(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
Senior Vice President, Investor Relations and Corporate Communications
awey@xerispharma.com
312-736-1237
Source: