Xeris Biopharma Reports Third Quarter 2023 Financial Results
Achieved record revenue of
Tightens full-year 2023 revenue guidance from
Ended Q3 with
Extended maturity of approximately two-thirds of 2025 Convertible Senior Notes to 2028
Successfully formulated the prespecified target product profile of the XeriJect™ formulation of TEPEZZA®
Hosting conference call and webcast today at
“We continue to demonstrate record revenue growth as we execute on our strategy. Because of this strong performance, we are further tightening our full year 2023 revenue guidance from
Third Quarter 2023 Highlights
|
Three months ended
|
|
Change |
|||||||
|
2023 |
|
2022 |
|
$ |
% |
||||
Product revenue (in thousands): |
|
|
|
|
|
|
||||
Gvoke |
$ |
17,735 |
|
$ |
13,663 |
|
$ |
4,072 |
29.8 |
|
Keveyis |
|
15,865 |
|
|
13,371 |
|
2,494 |
18.7 |
||
Recorlev |
|
8,097 |
|
|
2,520 |
|
5,577 |
nm |
||
Product revenue, net |
|
41,697 |
|
|
29,554 |
|
12,143 |
41.1 |
||
Royalty, contract and other revenue |
|
6,623 |
|
|
171 |
|
6,452 |
nm |
||
Total revenue |
$ |
48,320 |
|
$ |
29,725 |
|
$ |
18,595 |
62.6 |
|
nm - not meaningful |
Commercial Products
-
Gvoke®: Third quarter 2023 net revenue was
$17.7 million as compared to$13.7 million in the third quarter of 2022 – an increase of approximately 30%. Gvoke prescriptions topped 58,000 for the first time, growing 52% compared to the same period in 2022. Gvoke’s market share of the retail TRx glucagon market grew to over 31% through late October. -
Keveyis®: Third quarter net revenue was
$15.9 million – an increase of approximately 19% compared to the same period in 2022. The average number of patients on Keveyis increased approximately 5% from the same period in 2022. -
Recorlev®: Third quarter net revenue was
$8.1 million – an increase of$5.6 million compared to the same period of 2022. The average number of patients on Recorlev increased over 203% from the same period in 2022.
Pipeline Program
- XeriSol® levothyroxine (XP-8121): The Phase 2 clinical study is over 85% enrolled, and the study should be completed in the first half of 2024 based on the current enrollment rate.
Technology Partnerships
-
Horizon/Amgen: Xeris successfully formulated the prespecified target product profile of the XeriJect™ formulation of TEPEZZA® which triggered revenue of
$6.0 million in the third quarter from a milestone payment under the research collaboration and option agreement with Horizon (subsequently acquired by Amgen) that was signed inNovember 2022 . The payment was subsequently received in the fourth quarter. Amgen has the option to license the XeriJect technology to further the development of an ultra-concentrated, ready-to-use, subcutaneous injection of TEPEZZA®.
Year-to-Date 2023 Financial Results
|
Nine Months Ended |
|
Change |
|||||||
|
2023 |
|
2022 |
|
$ |
% |
||||
Product revenue (in thousands): |
|
|
|
|
|
|
||||
Gvoke |
$ |
48,406 |
|
$ |
37,595 |
|
$ |
10,811 |
28.8 |
|
Keveyis |
|
42,708 |
|
|
35,506 |
|
|
7,202 |
20.3 |
|
Recorlev |
|
19,741 |
|
|
3,623 |
|
|
16,118 |
nm |
|
Product revenue, net |
|
110,855 |
|
|
76,724 |
|
|
34,131 |
44.5 |
|
Royalty, contract and other revenue |
|
8,669 |
|
|
380 |
|
|
8,289 |
nm |
|
Total revenue |
$ |
119,524 |
|
$ |
77,104 |
|
$ |
42,420 |
55.0 |
|
nm - not meaningful |
-
Gvoke®: Net revenue was
$48.4 million for the nine months endedSeptember 30, 2023 , a 29% increase compared to prior year. Gvoke prescriptions for the first three quarters of 2023 were over 156,000 TRx’s, growing 51% compared to the same period in 2022. The growth in product demand was partially offset by a decrease in net pricing. -
Keveyis®: Net revenue was
$42.7 million for the nine months endedSeptember 30, 2023 , a 20% increase from last year. This increase was driven by higher patient demand and an increase in net pricing. -
Recorlev®: Net revenue was
$19.7 million for the nine months endedSeptember 30,2023 , a$16.1 million increase from last year, driven primarily by increases in the number of patients on therapy.
Cost of goods sold increased by
Research and development expenses decreased by
Selling, general and administrative expenses increased by
Net Loss was
Cash, cash equivalents, and short-term investments at
Shares outstanding at
Upcoming Events
Xeris will participate in the following investor conferences:
-
Jefferies London Healthcare Conference ,November 14-16, 2023 -
14th Annual
Craig-Hallum Alpha Select Conference ,November 16, 2023 (1x1s only) -
35th Annual
Piper Sandler Healthcare Conference ,November 28-30, 2023
Details of each event will be available on Xeris’ website. Contact the respective sponsor to request a 1x1 meeting.
Third Quarter Conference Call and Webcast Details
Xeris will host a conference call and webcast on
In addition, a live audio of the conference call will be available as a webcast. To join the webcast, please visit “Events” on the investor relations page of the Company’s website at www.xerispharma.com or use the following link: https://events.q4inc.com/attendee/482975153.
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing 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®, the first and only FDA-approved therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect™, supporting long-term product development and commercial success.
Forward-Looking Statements
Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans and prospects for
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) |
|||||||||||
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||
|
2023 |
|
2022 |
|
2023 |
|
2022 |
||||
Product revenue, net |
$ |
41,697 |
|
$ |
29,554 |
|
$ |
110,855 |
|
$ |
76,724 |
Royalty, contract and other revenue |
|
6,623 |
|
|
171 |
|
|
8,669 |
|
|
380 |
Total revenue |
|
48,320 |
|
|
29,725 |
|
|
119,524 |
|
|
77,104 |
Costs and expenses: |
|
|
|
|
|
|
|
||||
Cost of goods sold |
|
8,201 |
|
|
5,260 |
|
|
21,075 |
|
|
16,343 |
Research and development |
|
5,034 |
|
|
6,043 |
|
|
15,959 |
|
|
16,011 |
Selling, general and administrative |
|
37,287 |
|
|
34,491 |
|
|
108,527 |
|
|
103,388 |
Amortization of intangible assets |
|
2,711 |
|
|
2,711 |
|
|
8,132 |
|
|
8,132 |
Total costs and expenses |
|
53,233 |
|
|
48,505 |
|
|
153,693 |
|
|
143,874 |
Loss from operations |
|
(4,913) |
|
|
(18,780) |
|
|
(34,169) |
|
|
(66,770) |
Other expense |
|
(7,614) |
|
|
(3,390) |
|
|
(15,709) |
|
|
(16,046) |
Net loss before benefit from income taxes |
|
(12,527) |
|
|
(22,170) |
|
|
(49,878) |
|
|
(82,816) |
Benefit from income taxes |
|
338 |
|
|
339 |
|
|
1,013 |
|
|
1,086 |
Net loss |
$ |
(12,189) |
|
$ |
(21,831) |
|
$ |
(48,865) |
|
$ |
(81,730) |
|
|
|
|
|
|
|
|
||||
Net loss per common share - basic and diluted |
$ |
(0.09) |
|
$ |
(0.16) |
|
$ |
(0.36) |
|
$ |
(0.60) |
|
|
|
|
|
|
|
|
||||
Weighted average common shares outstanding - basic and diluted |
|
138,059,781 |
|
|
135,951,761 |
|
|
137,523,202 |
|
|
135,508,203 |
CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) |
|||||||
|
|
|
|
||||
|
(unaudited) |
|
|
||||
Assets |
|
|
|
||||
Current assets: |
|
|
|
||||
Cash and cash equivalents |
$ |
46,143 |
|
$ |
121,966 |
||
Short-term investments |
|
19,832 |
|
|
— |
||
Trade accounts receivable, net |
|
45,966 |
|
|
30,830 |
||
Inventory |
|
38,143 |
|
|
24,735 |
||
Prepaid expenses and other current assets |
|
7,967 |
|
|
9,287 |
||
Total current assets |
|
158,051 |
|
|
186,818 |
||
Property and equipment, net |
|
6,185 |
|
|
5,516 |
||
Intangible assets, net |
|
112,475 |
|
|
120,607 |
||
|
|
22,859 |
|
|
22,859 |
||
Operating lease right-of-use assets |
|
23,407 |
|
|
3,992 |
||
Other assets |
|
4,807 |
|
|
4,730 |
||
Total assets |
$ |
327,784 |
|
$ |
344,522 |
||
Liabilities and Stockholders’ Equity |
|
|
|
||||
Current liabilities: |
|
|
|
||||
Accounts payable |
$ |
12,078 |
|
$ |
4,606 |
||
Current operating lease liabilities |
|
2,366 |
|
|
1,580 |
||
Other accrued liabilities |
|
19,073 |
|
|
36,786 |
||
Accrued trade discounts and rebates |
|
21,554 |
|
|
16,818 |
||
Accrued returns reserve |
|
13,328 |
|
|
11,173 |
||
Current portion of contingent value rights |
|
17,517 |
|
|
— |
||
Other current liabilities |
|
1,123 |
|
|
2,658 |
||
Total current liabilities |
|
87,039 |
|
|
73,621 |
||
Long-term debt, net of unamortized debt issuance costs |
|
190,423 |
|
|
187,075 |
||
Non-current contingent value rights |
|
5,099 |
|
|
25,688 |
||
Non-current operating lease liabilities |
|
35,154 |
|
|
9,402 |
||
Deferred tax liabilities |
|
2,504 |
|
|
3,518 |
||
Other liabilities |
|
3,700 |
|
|
31 |
||
Total liabilities |
|
323,919 |
|
|
299,335 |
||
Total stockholders’ equity |
|
3,865 |
|
|
45,187 |
||
Total liabilities and stockholders’ equity |
$ |
327,784 |
|
$ |
344,522 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20231109523978/en/
Senior Vice President, Investor Relations and Corporate Communications
awey@xerispharma.com
312-736-1237
Source: