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Xeris Pharmaceuticals Reports Third Quarter 2019 Financial Results and Highlights

Key Takeaway: Xeris Pharmaceuticals reported its third quarter financial results, highlighting the FDA approval of Gvoke, a ready-to-use glucagon injection. The company plans to launch Gvoke commercially and is focused on obtaining managed care coverage. Despite a significant net loss and rising expenses, Xeris anticipates reporting data from Phase 2 studies by year-end.

Market Sentiment Analysis

POSITIVE FACTORS

  • FDA approval of Gvoke marks a significant milestone for Xeris.
  • Gvoke offers a reliable solution for severe hypoglycemia.
  • Positive reception from the diabetes community for Gvoke.
  • Upcoming clinical data may enhance the company's product portfolio.

CONCERNS & RISKS

  • Net loss increased significantly compared to the previous year.
  • R&D and SG&A expenses rose sharply, impacting financial performance.

Full Press Release Details

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

Corporate

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, visitwww.xerispharma.com, or follow us onTwitter,LinkedInorInstagram.
Forward-Looking StatementsAny 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.

Investor ContactAllison WeySenior Vice President, Investor Relations and Corporate Communicationsawey@xerispharma.com312-736-1237

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 $ 45,716
Short-term investments 46,311 66,917
Accounts receivable, net 874 2,869
Prepaid expenses and other current assets 2,631 2,397
Total current assets 105,976 117,899
Investments 13,913 -
Property and equipment, net 7,952 2,034
Other assets 259 95
Total assets $ 128,100 $ 120,028
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 1,678 $ 866
Accrued expenses 15,706 8,214
Warrant liabilities 302 860
Deferred grant awards 106 232
Total current liabilities 17,792 10,172
Long-term debt, net of unamortized deferred costs 58,124 31,890
Other liabilities 8,528 2,560
Total liabilities 84,444 44,622
Total stockholders' equity 43,656 75,406
Total 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 EndedSeptember 30, Nine Months EndedSeptember 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

Frequently Asked Questions

What is Gvoke?

Gvoke is a ready-to-use glucagon injection approved by the FDA for treating severe hypoglycemia.

When will Gvoke be commercially available?

Xeris plans to commence the commercial launch of Gvoke next week.

What were Xeris' financial results for Q3 2019?

Xeris reported a net loss of $32.8 million for Q3 2019, compared to $14.8 million in 2018.

What are the upcoming plans for Xeris?

Xeris expects to report data from three Phase 2 studies by year-end.

How much cash did Xeris have as of September 30, 2019?

Xeris reported total cash and investments of $116.4 million as of September 30, 2019.

Last updated: Nov 7, 2019