Gvoke™ (glucagon injection) pre-filled syringe (PFS) – now available by prescription
MAA for ready-to-use glucagon on track for submission to EMA by year-end
Data from three Phase 2 studies expected by year-end
CHICAGO, Nov. 07, 2019 (GLOBE NEWSWIRE) — Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced financial results for the third quarter and nine months ended September 30, 2019.
“We’ve reached one of our most significant milestones as a company during the third quarter of 2019 – our first U.S. FDA approval of Gvoke – the first pre-mixed, pre-filled, pre-measured liquid stable glucagon to treat severe hypoglycemia. With Gvoke, people with diabetes and caregivers now have a solution that they can count on. I am very encouraged with the reception and enthusiasm of the diabetes community for this important new advancement,” said Paul R. Edick, Chairman and Chief Executive Officer of Xeris Pharmaceuticals. “Next week we will commence the commercial launch of Gvoke PFS. In addition to calling on healthcare professionals, we will continue to focus our efforts for the balance of 2019 on obtaining managed care coverage to enable access to Gvoke for patients,” Mr. Edick continued. “Looking ahead over the next few months, we also expect to report data from several clinical programs that may further support the potential and breadth of our formulation technology platforms.”
Third Quarter 2019 Highlights, Recent and Upcoming Events
Ready-to-use Glucagon Programs
Other XeriSol™ Programs
Third Quarter and Year-to-Date 2019 Financial Highlights
Cash position: As of September 30, 2019, Xeris reported total cash, cash equivalents, and investments (collectively, “cash and investments”) of $116.4 million, compared to $112.6 million at December 31, 2018.
Research and development (R&D) expenses: R&D expenses for the three and nine months ended September 30, 2019 were $15.5 million and $48.0 million, respectively, compared to $10.9 million and $28.3 million for the three and nine months ended September 30, 2018, respectively. The increases were primarily driven by manufacturing costs related to Gvoke prior to commercialization, increased expenses associated with Xeris’ clinical and preclinical trials and increased personnel expenses.
Selling, general and administrative (SG&A) expenses: SG&A expenses for the three and nine months ended September 30, 2019 were $14.9 million and $42.4 million, respectively, compared to $4.7 million and $12.4 million for the three and nine months ended September 30, 2018, respectively. The increases were driven by increased marketing and selling expenses and increased personnel expenses primarily to support commercialization efforts of Gvoke.
Net loss: For the three months ended September 30, 2019, Xeris reported a net loss of $32.8 million, or $1.22 per share, compared to a net loss of $14.8 million, or $0.71 per share, for the same period in 2018. For the nine months ended September 30, 2019, Xeris reported a net loss of $92.5 million, or $3.58 per share, compared to a net loss of $39.7 million, or $4.36 per share, for the same period in 2018.
About Xeris Pharmaceuticals, Inc.
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™. Its proprietary XeriSol™ and XeriJect™ formulation technologies have the potential to offer distinct advantages over conventional product formulations, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. With Xeris’ technology, 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 Chicago, IL. For more information, visit , or follow us on , or .
Any statements in this press release about future expectations, plans and prospects for Xeris Pharmaceuticals, Inc., including statements regarding the acceptance of Gvoke™ in the marketplace, the market and therapeutic potential of its product candidates, expectations regarding clinical data, the timing or likelihood of commercialization of its product candidates, the potential utility of its formulation platforms and other statements containing the words “will,” “would,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, without limitation, the regulatory approval of its product candidates, its ability to market and sell its products, if approved, and other factors discussed in the “Risk Factors” section of the most recently filed Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in Xeris’ subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Xeris expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
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.
Senior Vice President, Investor Relations and Corporate Communications
XERIS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands) September 30,
2019 December 31,
2018 (unaudited) Assets Current assets: Cash and cash equivalents$56,160 $45,716Short-term investments 46,311 66,917Accounts receivable, net 874 2,869Prepaid expenses and other current assets 2,631 2,397Total current assets 105,976 117,899Investments 13,913 -Property and equipment, net 7,952 2,034Other assets 259 95Total assets$128,100 $120,028 Liabilities and Stockholders‘ Equity Current liabilities: Accounts payable$1,678 $866Accrued expenses 15,706 8,214Warrant liabilities 302 860Deferred grant awards 106 232Total current liabilities 17,792 10,172Long-term debt, net of unamortized deferred costs 58,124 31,890Other liabilities 8,528 2,560Total liabilities 84,444 44,622Total stockholders‘ equity 43,656 75,406Total liabilities and stockholders‘ equity$128,100 $120,028
XERIS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except share and per share data; unaudited) Three Months Ended
September 30, Nine Months Ended
September 30, 2019 2018 2019 2018 Grant income$314 $582 $843 $1,611 Service revenue 9 – 48 53 Cost of revenue 10 – 33 42 Gross profit 313 582 858 1,622 Operating expenses: Research and development 15,518 10,875 48,018 28,264 Selling, general and administrative 14,877 4,650 42,419 12,388 Expense from operations 30,395 15,525 90,437 40,652 Loss from operations (30,082) (14,943) (89,579) (39,030)Other income (expense): Interest and other income 657 462 2,173 796 Interest expense (3,507) (737) (5,632) (1,490)Change in fair value of warrants 96 451 540 63 Total other income (expense) (2,754) 176 (2,919) (631)Net loss$(32,836) $(14,767) $(92,498) $(39,661) Net loss per common share – basic and diluted$(1.22) $(0.71) $(3.58) $(4.36) Weighted average common shares outstanding, basic and diluted 26,942,591 20,714,475 25,810,113 9,104,491