Xeris Biopharma Reports First Quarter 2023 Financial Results
Achieved first quarter total revenue of
Ended Q1 2023 with
Affirms 2023 guidance: total revenue of
Announced research collaboration and option agreement with Regeneron for XeriJect® formulation®
Hosting conference call and webcast today at
“We had a very strong start to 2023 with record total revenue, strong underlying patient demand in all three commercial products, and the addition of another XeriJect collaboration,” said
First Quarter Highlights and Recent Events
|
Three Months Ended |
|
Change |
||||||
|
2023 |
|
2022 |
|
$ |
% |
|||
Product revenue (in thousands): |
|
|
|
|
|
|
|||
Gvoke |
$ |
15,033 |
|
$ |
12,452 |
|
$ |
2,581 |
20.7 |
Keveyis |
|
12,755 |
|
|
9,324 |
|
|
3,431 |
36.8 |
Recorlev |
|
4,477 |
|
|
134 |
|
|
4,343 |
nm |
Product revenue, net |
|
32,265 |
|
|
21,910 |
|
|
10,355 |
47.3 |
Royalty, contract and other revenue |
|
931 |
|
|
163 |
|
|
768 |
nm |
Total revenue |
$ |
33,196 |
|
$ |
22,073 |
|
$ |
11,123 |
50.4 |
nm - not meaningful |
|
|
|
|
|
|
Commercial Products
-
Gvoke®: First quarter net revenue was
$15.0 million as compared to$12.5 million in the first quarter of 2022, an increase of approximately 21%. Gvoke prescriptions topped 45,000 for the first time, growing approximately 50% compared to the same period in 2022. Year over year glucagon TRx and NRx market growth was 10% and 9%, respectively. At the end of April, Gvoke’s NRx and TRx market share of the retail glucagon market exceeded 30% and 29%, respectively. In the first quarter, theU.S. Patent and Trademark Office issued US Patent Number 11,590,205, entitled ‘METHODS FOR PRODUCING STABLE THERAPEUTIC GLUCAGON FORMULATIONS IN APROTIC POLAR SOLVENTS.’ The claims in this newly issued patent cover certain pharmaceutical formulations in Xeris’ Gvoke® product line, methods of use of such formulations in treating hypoglycemia, and methods of manufacturing the therapeutic formulations. -
Keveyis®: First quarter net revenue was
$12.8 million , an increase of approximately 37% compared to the same period in 2022, driven by higher patient demand. -
Recorlev®: First quarter net revenue was
$4.5 million driven primarily by increases in the number of patients on therapy.
Pipeline and Partnership Programs
- XeriSol® levothyroxine (XP-8121): The Phase 2 study is on track to begin enrolling patients in the second quarter.
- XeriJect®: In March, Xeris announced a research collaboration and option agreement with Regeneron to develop an ultra-concentrated, ultra-highly concentrated, ready-to-use, small volume subcutaneous injections of two undisclosed monoclonal antibodies developed by Regeneron. Regeneron has an option to commercially license XeriJect for these molecules and nominate additional molecules for reformulation and potential commercialization.
Corporate Highlights
-
In March, Xeris appointed
Ricki Fairley to its Board of Directors, increasing the number of members to nine. -
Xeris will hold its Annual Meeting of Stockholders on
June 7, 2023 . -
Members of Xeris’ senior management will participate in
Jefferies Global Healthcare Conference June 7-9, 2023 , inNew York City .
First Quarter 2023 Other Results
Cost of goods sold was
Research and development expenses decreased
Selling, general and administrative expenses decreased
Net Loss for the three months ended
Cash, cash equivalents, and short-term investments at
Conference Call and Webcast Details
Xeris will host a conference call and webcast today,
To pre-register for the call, please go to the following link: https://www.netroadshow.com/events/login?show=148ea405&confId=49077
After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering at least ten minutes before the call starts. Following the conference call, a replay will be available until
To join the webcast, please visit “Events” on investor relations page of the Company’s website at www.xerispharma.com or use this link: https://events.q4inc.com/attendee/964102801
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing differentiated and innovative products across a range of therapies. Xeris has three commercially available products: Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia; Keveyis®, a proven therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris has a diverse pipeline of development and partnered programs using its formulation sciences, XeriSol™ and XeriJect™, to support long-term product development and commercial success.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
|
||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||
(in thousands, except share and per share data) |
||||||||
(unaudited) |
||||||||
|
|
Three months ended |
||||||
|
|
2023 |
|
2022 |
||||
Product revenue, net |
|
$ |
32,265 |
|
|
$ |
21,910 |
|
Royalty, contract and other revenue |
|
|
931 |
|
|
|
163 |
|
Total revenue |
|
|
33,196 |
|
|
|
22,073 |
|
Costs and expenses: |
|
|
|
|
||||
Cost of goods sold |
|
|
5,319 |
|
|
|
6,273 |
|
Research and development |
|
|
4,838 |
|
|
|
6,250 |
|
Selling, general and administrative |
|
|
33,605 |
|
|
|
35,913 |
|
Amortization of intangible assets |
|
|
2,711 |
|
|
|
2,711 |
|
Total costs and expenses |
|
|
46,473 |
|
|
|
51,147 |
|
Loss from operations |
|
|
(13,277 |
) |
|
|
(29,074 |
) |
Other expense |
|
|
(3,557 |
) |
|
|
(5,048 |
) |
Net loss before benefit from income taxes |
|
|
(16,834 |
) |
|
|
(34,122 |
) |
Benefit from income taxes |
|
|
— |
|
|
|
408 |
|
Net loss |
|
$ |
(16,834 |
) |
|
$ |
(33,714 |
) |
|
|
|
|
|
||||
Net loss per common share - basic and diluted |
|
$ |
(0.12 |
) |
|
$ |
(0.25 |
) |
|
|
|
|
|
||||
Weighted average common shares outstanding - basic and diluted |
|
|
137,142,565 |
|
|
|
135,032,782 |
|
|
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(in thousands) |
|||||
|
|
|
|
||
|
(unaudited) |
|
|
||
Assets |
|
|
|
||
Current assets: |
|
|
|
||
Cash and cash equivalents |
$ |
50,984 |
|
$ |
121,966 |
Short-term investments |
|
44,118 |
|
|
— |
Trade accounts receivable, net |
|
30,860 |
|
|
30,830 |
Inventory |
|
29,039 |
|
|
24,735 |
Prepaid expenses and other current assets |
|
10,512 |
|
|
9,287 |
Total current assets |
|
165,513 |
|
|
186,818 |
Property and equipment, net |
|
6,477 |
|
|
5,516 |
|
|
117,896 |
|
|
120,607 |
Operating lease right-of-use assets |
|
22,859 |
|
|
22,859 |
Intangible assets, net |
|
3,886 |
|
|
3,992 |
Other assets |
|
4,729 |
|
|
4,730 |
Total assets |
$ |
321,360 |
|
$ |
344,522 |
Liabilities and Stockholders’ Equity |
|
|
|
||
Current liabilities: |
|
|
|
||
Accounts payable |
$ |
11,983 |
|
$ |
4,606 |
Current operating lease liabilities |
|
1,448 |
|
|
1,580 |
Other accrued liabilities |
|
20,149 |
|
|
36,786 |
Accrued trade discounts and rebates |
|
16,874 |
|
|
16,818 |
Accrued returns reserve |
|
13,254 |
|
|
11,173 |
Current portion of contingent value rights |
|
14,958 |
|
|
— |
Other current liabilities |
|
2,757 |
|
|
2,658 |
Total current liabilities |
|
81,423 |
|
|
73,621 |
Long-term debt, net of unamortized debt issuance costs |
|
187,623 |
|
|
187,075 |
Contingent value rights |
|
9,371 |
|
|
25,688 |
Non-current operating lease liabilities |
|
9,346 |
|
|
9,402 |
Deferred tax liabilities |
|
3,518 |
|
|
3,518 |
Other liabilities |
|
31 |
|
|
31 |
Total liabilities |
|
291,312 |
|
|
299,335 |
Total stockholders’ equity |
|
30,048 |
|
|
45,187 |
Total liabilities and stockholders’ equity |
$ |
321,360 |
|
$ |
344,522 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230509005324/en/
Investor Contact
Senior Vice President, Investor Relations and Corporate Communications
awey@xerispharma.com
312-736-1237
Source: