Xeris Pharmaceuticals Reports Fourth Quarter and Full-year 2020 Financial Results and Recent Highlights
Gvoke® net sales of
Continued Gvoke prescription growth – over 350% in 2020
Strong cash position of
Conference call and webcast today at
“Despite the obvious challenges of 2020, I believe it was a very successful year for Xeris, and in particular, the fourth quarter. We saw continuous growth in demand for Gvoke throughout the year with quarter over quarter increases in prescriptions and market share, which was accelerated by the launch of Gvoke HypoPen in July, and we did so while operating our commercial organization virtually for 10 months of the year. We also reported positive clinical data in several clinical programs, we put more cash on the balance sheet, and equitized a large portion of our convertible debt,” said
Fourth Quarter 2020 Highlights and Recent Events
Marketed and Approved Products
- Gvoke prescriptions grew approximately 11% quarter over quarter and over 350% in 2020.
-
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, received a positive opinion from the European Medicines Agency’s (EMA)
Committee for Medicinal Products for Human Use (CHMP) inDecember 2020 , and theEuropean Commission (EC) granted the marketing authorisation inFebruary 2021 . - The Company is actively seeking a partner to commercialize Ogluo in the EU and other regions, with a targeted fourth quarter 2021 launch in select EU countries.
-
In
December 2020 , Xeris entered into an exclusive distribution agreement withMegapharm Ltd. (“Megapharm”), a leadingIsrael -based pharmaceutical company, for the commercialization of Gvoke inIsrael and thePalestinian Authority .
Ready-to-use Glucagon Programs
- Xeris received feedback from FDA in late December and early January on mini/micro dose development programs in Exercise-Induced Hypoglycemia (EIH) and Post-Bariatric Hypoglycemia (PBH). The Company is currently finalizing expectations with the FDA for registration programs for both, including the study design for Phase 3 clinical trials, to support indications for its ready-to-use glucagon in the prevention of EIH and PBH. Based on the FDA feedback for each program, the Company anticipates advancing at least one of the glucagon mini/micro dose programs.
Other XeriSol™ Programs
- Xeris received feedback from the FDA and is finalizing expectations for a registration program for its XeriSol pramlintide-insulin co-formulation program, including a study design for a Phase 3 program. Based on the FDA feedback, the Company anticipates seeking 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
-
To date, a total principal amount of
$39.1 million of Convertible Notes converted into 13,171,791 shares of the Company’s common stock. As ofDecember 31, 2020 , the outstanding balance of Convertible Notes was$47.2 million .
Fourth Quarter and Full-Year 2020 Financial Highlights
Net sales: Net sales for Gvoke for the fourth quarter of 2020 and full-year 2020 were
Cost of goods sold: Cost of goods sold for the fourth quarter of 2020 and full-year 2020 were
Research and development (R&D) expenses: R&D expenses for the fourth quarter and full-year 2020 were
Selling, general and administrative (SG&A) expenses: SG&A expenses for the fourth quarter and full year ended
Net loss: For the fourth quarter 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 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.
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||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||||||
(in thousands, except share and per share data) |
||||||||||||||||
Three Months Ended
|
Twelve Months Ended
|
|||||||||||||||
2020 |
2019 |
2020 |
2019 |
|||||||||||||
Net sales |
$ |
7,089 |
|
$ |
1,627 |
|
$ |
20,155 |
|
$ |
1,627 |
|
||||
Grant and other income |
|
83 |
|
|
237 |
|
|
280 |
|
|
1,095 |
|
||||
Cost of goods sold |
|
3,407 |
|
|
1,603 |
|
|
9,328 |
|
|
1,603 |
|
||||
Gross profit |
|
3,765 |
|
|
261 |
|
|
11,107 |
|
|
1,119 |
|
||||
Operating expenses: | ||||||||||||||||
Research and development |
|
5,110 |
|
|
12,420 |
|
|
20,921 |
|
|
60,438 |
|
||||
Selling, general and administrative |
|
17,998 |
|
|
20,642 |
|
|
73,732 |
|
|
63,061 |
|
||||
Total operating expenses |
|
23,108 |
|
|
33,062 |
|
|
94,653 |
|
|
123,499 |
|
||||
Loss from operations |
|
(19,343 |
) |
|
(32,801 |
) |
|
(83,546 |
) |
|
(122,380 |
) |
||||
Other income (expense): | ||||||||||||||||
Interest and other income |
|
2,022 |
|
|
640 |
|
|
2,965 |
|
|
2,813 |
|
||||
Interest expense |
|
(4,591 |
) |
|
(1,531 |
) |
|
(10,660 |
) |
|
(7,163 |
) |
||||
Change in fair value of warrants |
|
55 |
|
|
152 |
|
|
(9 |
) |
|
692 |
|
||||
Total other income (expense) |
|
(2,514 |
) |
|
(739 |
) |
|
(7,704 |
) |
|
(3,658 |
) |
||||
Net loss before benefit from income taxes |
|
(21,857 |
) |
|
(33,540 |
) |
|
(91,250 |
) |
|
(126,038 |
) |
||||
Benefit from income taxes |
|
- |
|
|
458 |
|
|
110 |
|
|
458 |
|
||||
Net loss |
$ |
(21,857 |
) |
$ |
(33,082 |
) |
$ |
(91,140 |
) |
$ |
(125,580 |
) |
||||
Net loss per common share - basic and diluted |
$ |
(0.41 |
) |
$ |
(1.23 |
) |
$ |
(2.14 |
) |
$ |
(4.81 |
) |
||||
Weighted average common shares outstanding, basic and diluted |
|
53,505,197 |
|
|
27,001,059 |
|
|
42,642,901 |
|
|
26,110,297 |
|
|
||||||
CONSOLIDATED BALANCE SHEETS |
||||||
(in thousands) |
||||||
|
|
|||||
Assets | ||||||
Current assets: | ||||||
Cash and cash equivalents |
$ |
37,598 |
$ |
19,519 |
||
Short-term investments |
|
96,190 |
|
56,030 |
||
Trade accounts receivable, net |
|
6,875 |
|
4,693 |
||
Inventory |
|
8,353 |
|
2,176 |
||
Prepaid expenses and other current assets |
|
3,196 |
|
5,065 |
||
Total current assets |
|
152,212 |
|
87,483 |
||
Investments |
|
- |
|
13,231 |
||
Property and equipment, net |
|
6,707 |
|
7,853 |
||
Other assets |
|
232 |
|
420 |
||
Total assets |
$ |
159,151 |
$ |
108,987 |
||
Liabilities and Stockholders' Equity | ||||||
Current liabilities: | ||||||
Accounts payable |
$ |
3,117 |
$ |
5,603 |
||
Other accrued liabilities |
|
15,895 |
|
18,119 |
||
Accrued trade discounts and rebates |
|
5,984 |
|
1,375 |
||
Accrued returns reserve |
|
2,889 |
|
1,957 |
||
Other current liabilities |
|
322 |
|
284 |
||
Total current liabilities |
|
28,207 |
|
27,338 |
||
Long-term debt, net of unamortized deferred issuance costs |
|
87,021 |
|
58,305 |
||
Deferred rent |
|
6,629 |
|
7,076 |
||
Other liabilities |
|
3,533 |
|
1,832 |
||
Total liabilities |
|
125,390 |
|
94,551 |
||
Total stockholders' equity |
|
33,761 |
|
14,436 |
||
Total liabilities and stockholders' equity |
$ |
159,151 |
$ |
108,987 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20210309005183/en/
Investor Contact
Senior Vice President, Investor Relations and Corporate Communications
awey@xerispharma.com
312-736-1237
Source: