UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_______________________________
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 6, 2019
_______________________________
XERIS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
______________________________
Delaware | 001-38536 | 20-3352427 | |||
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | |||
180 N. LaSalle Street, Suite 1600 Chicago, Illinois | 60601 | ||||
(Address of Principal Executive Offices) | (Zip Code) | ||||
(844) 445-5704 | |||||
(Registrant's telephone number, including area code) | |||||
Not Applicable | |||||
(Former name or former address, if changed since last report) | |||||
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: | ||||||||
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||||
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||||
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||||
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||||
Securities registered pursuant to Section 12(b) of the Act: | ||||||||
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Common Stock, par value $0.0001 per share | XERS | The Nasdaq Global Select Market | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). | ||||||||
Emerging growth company þ | ||||||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨ | ||||||||
Item 2.02 Results of Operations and Financial Condition
On August 6, 2019, Xeris Pharmaceuticals, Inc. (the “Company”) issued a press release containing information about the Company’s results of operations and business highlights for the three and six months ended June 30, 2019. A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits:
99.1 | Press release issued by Xeris Pharmaceuticals, Inc. dated August 6, 2019. |
EXHIBIT INDEX
Exhibit No. | Description |
99.1 | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: August 6, 2019 | Xeris Pharmaceuticals, Inc. | |||
By: | /s/ Barry M. Deutsch | |||
Name: Barry M. Deutsch | ||||
Title: Chief Financial Officer | ||||
Exhibit 99.1
XERIS PHARMACEUTICALS ANNOUNCES SECOND QUARTER 2019 FINANCIAL RESULTS AND HIGHLIGHTS
CHICAGO, IL; August 6, 2019 - 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 second quarter and six months ended June 30, 2019.
“The second quarter saw several important highlights including the active enrollment in a number of Phase 2 clinical programs that will keep us on track to report data before the end of the year, the progress of additional preclinical programs in new therapeutic areas, and our continuing commercial preparation in advance of the FDA’s decision on our Gvoke™ NDA,” said Paul R. Edick, Chairman and Chief Executive Officer of Xeris Pharmaceuticals. “We look forward to the FDA decision on Gvoke in the coming weeks and, if approved, we plan to proceed with our launch late in the fourth quarter."
Second Quarter 2019 Highlights and Recent Events
- Xeris released favorable data from a Phase 1 study of XeriSol™ formulated diazepam and, based on these results, anticipates initiating a Phase 2 weight-based dosing study by year-end.
- Xeris announced that the FDA had extended its PDUFA goal date to September 10, 2019 for Gvoke. If approved, the Company anticipates launching Gvoke late in the fourth quarter of 2019.
- Xeris reported positive outcomes from a global Phase 3 study of Gvoke. This additional data will support the Marketing Authorization Application (MAA), which the Company anticipates submitting to EMA by year-end 2019.
- Xeris announced that it dosed the first subject in a Phase 2 study of ready-to-use (RTU) glucagon in patients who experience hypoglycemic episodes following bariatric surgery (NCT03770637). This randomized, placebo-controlled, double-blind study will evaluate the efficacy, safety, and tolerability of the Xeris RTU glucagon in treating symptomatic postprandial hypoglycemia among patients with post-bariatric hypoglycemia initially during two in-patient clinical research center visits and then ongoing as part of a 12-week outpatient phase. Based on planned enrollment rates, Xeris anticipates reporting data from the in-clinic portion of the study in the second half of 2019.
- Data was presented at American Diabetes Association’s 79th Scientific Sessions (ADA), which included preclinical data of our XeriSol™ pramlintide-insulin co-formulation and regular insulin and lispro insulin, clinical data summarizing combined safety and efficacy of Gvoke, as well as clinical data using Xeris’ RTU glucagon in a dual hormone, closed-loop pump system.
Second Quarter and Year-to-Date 2019 Financial Highlights
Cash position: As of June 30, 2019, Xeris reported total cash, cash equivalents, and short-term investments (collectively, “cash and investments”) of $124.5 million, compared to $112.6 million at December 31, 2018.
Research and development (R&D) expenses: R&D expenses for the three and six months ended June 30, 2019 were $19.3 million and $32.5 million, respectively, compared to $8.7 million and $17.4 million for the three and six months ended June 30, 2018, respectively. The increases were primarily driven by manufacturing costs related to Gvoke prior to FDA approval and increased personnel expenses.
Selling, general and administrative (SG&A) expenses: SG&A expenses for the three and six months ended June 30, 2019 were $15.0 million and $27.5 million, respectively, compared to $4.5 million and $7.7 million for the three and six months ended June 30, 2018, respectively. The increases were driven by increased marketing and selling expenses and increased personnel expenses primarily due to additional headcount to support Gvoke commercialization efforts.
Net loss: For the three months ended June 30, 2019, Xeris reported a net loss of $34.4 million, or $1.28 per share, compared to a net loss of $13.0 million, or $3.07 per share, for the same period in 2018. For the six months ended June 30, 2019, Xeris reported a net loss of $59.7 million, or $2.36 per share, compared to a net loss of $24.9 million, or $7.76 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.
Forward-Looking Statements
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 Gvoke, 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.
Investor Contact
Allison Wey
Senior Vice President, Investor Relations and Corporate Communications
awey@xerispharma.com
312-736-1237
XERIS PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
June 30, 2019 | December 31, 2018 | ||||||
(unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 66,669 | $ | 45,716 | |||
Short-term investments | 57,841 | 66,917 | |||||
Accounts receivable, net | 826 | 2,869 | |||||
Prepaid expenses and other current assets | 813 | 2,397 | |||||
Total current assets | 126,149 | 117,899 | |||||
Property and equipment, net | 7,677 | 2,034 | |||||
Other assets | 68 | 95 | |||||
Total assets | $ | 133,894 | $ | 120,028 | |||
Liabilities and Stockholders' Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,840 | $ | 866 | |||
Accrued expenses | 15,609 | 8,214 | |||||
Current portion of long-term debt | 3,000 | — | |||||
Warrant liabilities | 403 | 860 | |||||
Deferred grant awards | 156 | 232 | |||||
Total current liabilities | 21,008 | 10,172 | |||||
Long-term debt, net of unamortized deferred costs | 29,403 | 31,890 | |||||
Other long-term liabilities | 8,692 | 2,560 | |||||
Total liabilities | 59,103 | 44,622 | |||||
Total stockholders' equity | 74,791 | 75,406 | |||||
Total liabilities and stockholders' equity | $ | 133,894 | $ | 120,028 | |||
XERIS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data; unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Grant income | $ | 314 | $ | 819 | $ | 529 | $ | 1,029 | ||||||||
Service revenue | 6 | — | 39 | 53 | ||||||||||||
Cost of revenue | 23 | — | 23 | 42 | ||||||||||||
Gross profit | 297 | 819 | 545 | 1,040 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 19,333 | 8,677 | 32,500 | 17,389 | ||||||||||||
Selling, general and administrative | 15,024 | 4,499 | 27,542 | 7,738 | ||||||||||||
Expense from operations | 34,357 | 13,176 | 60,042 | 25,127 | ||||||||||||
Loss from operations | (34,060 | ) | (12,357 | ) | (59,497 | ) | (24,087 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest and other income | 845 | 238 | 1,516 | 334 | ||||||||||||
Interest expense | (1,062 | ) | (562 | ) | (2,125 | ) | (753 | ) | ||||||||
Change in fair value of warrants | (108 | ) | (306 | ) | 444 | (388 | ) | |||||||||
Total other income (expense) | (325 | ) | (630 | ) | (165 | ) | (807 | ) | ||||||||
Net loss | $ | (34,385 | ) | $ | (12,987 | ) | $ | (59,662 | ) | $ | (24,894 | ) | ||||
Net loss per common share - basic and diluted | $ | (1.28 | ) | $ | (3.07 | ) | $ | (2.36 | ) | $ | (7.76 | ) | ||||
Weighted average common shares outstanding, basic and diluted | 26,889,398 | 4,231,054 | 25,234,489 | 3,205,998 | ||||||||||||