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Continuing to execute commercial build and launch readiness for Gvoke HypoPen™ and Gvoke PFS ™
Dosed first patient in a Phase 2 study evaluating ready-to-use (RTU) glucagon in EIH
Advancing diazepam to Phase 2 based on recently reported favorable Phase 1 results
Strengthened the balance sheet with February equity offering
CHICAGO, May 09, 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 first quarter ended March 31, 2019, as well as pipeline and corporate highlights.
“We have strong momentum already in 2019 with pipeline progress and infrastructure readily expanding in anticipation of our first commercial launch later this year. We remain focused on delivering on our near-term objectives, while training an eye toward our future," said Paul R. Edick, Chairman and Chief Executive Officer of Xeris Pharmaceuticals. "We are taking a thoughtful approach to building a strong and diverse portfolio of ready-to-use, liquid stable injectables, looking not only at the important applications using glucagon, but also in other areas where RTU and easier-to-use options may provide meaningful improvement in patients' lives. Starting with our recent first-in-man data in diazepam, the increasing breadth of our pipeline will reflect this growth strategy and demonstrate the broad utility of our technology platforms for patients, caregivers and the healthcare system."
First Quarter 2019 Corporate Highlight
Ready-to-Use Glucagon for Hypoglycemia
Ready-to-Use Products for Epilepsy and Diabetes
* orphan drug designation
First Quarter 2019 Financial Highlights
Cash position: As of March 31, 2019, Xeris reported total cash, cash equivalents, and short-term investments (collectively, “cash and investments”) of $147.7 million, compared to $112.6 million at December 31, 2018. In February 2019, the Company sold an aggregate of 5,996,775 shares of common stock at a price of $10.00 per share, which included the underwriters' partial exercise of their option to purchase additional common stock. Net proceeds from the offering were approximately $55.6 million after deducting underwriting discounts and commissions, as well as other public offering expenses.
Research and development (R&D) expenses: R&D expenses for the three months ended March 31, 2019 were $13.2 million, compared to $8.7 million for the same period in 2018. The increase was primarily driven by manufacturing costs related to Gvoke HypoPen and Gvoke PFS prior to FDA approval and increased personnel expenses.
Selling, general and administrative (SG&A) expenses: SG&A expenses for the three months ended March 31, 2019 were $12.5 million, compared to $3.2 million for the same period in 2018. The increase was driven by increased marketing and selling expenses and increased personnel expenses due to additional headcount to support commercialization efforts of the Gvoke HypoPen and Gvoke PFS.
Net loss: For the three months ended March 31, 2019, Xeris reported a net loss of $25.3 million, or $1.07 per share, compared to a net loss of $11.9 million, or $5.49 per share, for the same period in 2018.
About Xeris Pharmaceuticals, Inc.
Xeris is a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use, room-temperature stable injectable and infusible drug formulations. The Company’s proprietary XeriSol™ and XeriJect™ formulation technologies are being evaluated for the subcutaneous (SC) and intramuscular (IM) delivery of highly-concentrated, non-aqueous, ready-to-use formulations of peptides, small molecules, proteins, and antibodies using commercially available syringes, auto-injectors, multi-dose pens, and infusion pumps. XeriSol™ and XeriJect™ have the potential to offer distinct advantages over existing formulations of marketed and development-stage products, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. These attributes may lead to products that are easier to use by patients, caregivers, and health practitioners and reduce costs for payers and the healthcare system. Further information about Xeris can be found at www.xerispharma.com.
Any statements in this press release about future expectations, plans and prospects for Xeris Pharmaceuticals, Inc., including statements concerning the timing or likelihood of approval by the FDA of its NDA for its glucagon pen, the market and therapeutic potential of its product candidates, 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 Annual Report on Form 10-K 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 STATEMENTS OF OPERATIONS|
|(in thousands, except share and per share data; unaudited)|
|Three Months Ended
|Cost of revenue||-||42|
|Research and development||13,167||8,712|
|Selling, general and administrative||12,518||3,239|
|Expense from operations||25,685||11,951|
|Loss from operations||(25,437||)||(11,730||)|
|Other income (expense):|
|Change in fair market value of warrants||552||(82||)|
|Total other income (expense)||160||(177||)|
|Net loss per common share - basic and diluted||$||(1.07||)||$||(5.49||)|
|Weighted average common shares outstanding, basic and diluted||23,561,193||2,169,576|
|XERIS PHARMACEUTICALS, INC.|
|CONDENSED BALANCE SHEETS|
|March 31, 2019|
|December 31, 2018|
|Cash and cash equivalents||$||61,984||$||45,716|
|Accounts receivable, net||3,628||2,869|
|Prepaid expenses and other current assets||2,146||2,397|
|Total current assets||153,445||117,899|
|Property and equipment, net||7,430||2,034|
|Liabilities and Stockholders' Equity|
|Deferred grant awards||221||232|
|Total current liabilities||13,406||10,172|
|Long-term debt, net of unamortized deferred costs||32,141||31,890|
|Other long-term liabilities||8,323||2,560|
|Total stockholders' equity||107,100||75,406|
|Total liabilities and stockholders' equity||$||160,970||$||120,028|