Xeris Pharmaceuticals Reports Third Quarter 2019 Financial Results and Highlights
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
“We’ve reached one of our most significant milestones as a company during the third quarter of 2019 – our first U.S.
Third Quarter 2019 Highlights, Recent and Upcoming Events
Ready-to-use Glucagon Programs
- Xeris will begin its commercial launch of Gvoke pre-filled syringe (PFS), its 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, in the U.S in mid-November. Xeris’ salesforce will begin calling on healthcare professionals with an additional focus on enabling formulary inclusion and patient access. Gvoke PFS is now available by prescription for home delivery (powered by PillPack, an
Amazoncompany) and at local pharmacies through their preferred wholesalers. The Company still expects to launch Gvoke HypoPen™ in 2020.
- Xeris expects to submit a Marketing Authorization Application (MAA) to the
European Medicines Agency(EMA) by the end of 2019 for its ready-to-use liquid stable glucagon.
- Xeris expects data from the in-clinic portion of its Phase 2 study of post-bariatric hypoglycemia (PBH) before year-end.
- Xeris expects data from the in-clinic portion of its Phase 2 study of exercise-induced hypoglycemia (EIH) before year-end.
- Xeris has completed enrollment in its Phase 2 study of hypoglycemia-associated autonomic failure (HAAF). Data from the 28-day treatment period of this study is expected by year-end.
Other XeriSol™ Programs
- Xeris began dosing patients with Type 1 diabetes in a Phase 2 clinical study to evaluate its investigational ready-to-use, fixed-ratio co-formulation of pramlintide and insulin in patients with diabetes. Data from this study is anticipated in the first half of 2020.
- Xeris has initiated a weight-based dosing study in healthy volunteers of its investigational ready-to-use diazepam formulation. Data from this study is expected in the first half of 2020.
- Xeris expanded its debt facility to
$85 millionwith Oxford Finance and Silicon Valley Bank, which provides an interest-only period of up to three years and an extension of the maturity date.
- Xeris’ senior management will participate in a fireside chat at the
Jefferies London Healthcare Conferenceon November 21, 2019at 8:00 a.m.local time. Access to the live webcast and subsequent archived presentation will be available on the investor section of the Company’s website.
Third Quarter and Year-to-Date 2019 Financial Highlights
Cash position: As of
Research and development (R&D) expenses: R&D expenses for the three and nine months ended
Selling, general and administrative (SG&A) expenses: SG&A expenses for the three and nine months ended
Net loss: For the three months ended
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.
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.
Senior Vice President, Investor Relations and Corporate Communications
|XERIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||56,160||$||45,716|
|Accounts receivable, net||874||2,869|
|Prepaid expenses and other current assets||2,631||2,397|
|Total current assets||105,976||117,899|
|Property and equipment, net||7,952||2,034|
|Liabilities and Stockholders' Equity|
|Deferred grant awards||106||232|
|Total current liabilities||17,792||10,172|
|Long-term debt, net of unamortized deferred costs||58,124||31,890|
|Total stockholders' equity||43,656||75,406|
|Total liabilities and stockholders' equity||$||128,100||$||120,028|
|XERIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except share and per share data; unaudited)|
|Three Months Ended
|Nine Months Ended
|Cost of revenue||10||-||33||42|
|Research and development||15,518||10,875||48,018||28,264|
|Selling, general and administrative||14,877||4,650||42,419||12,388|
|Expense from operations||30,395||15,525||90,437||40,652|
|Loss from operations||(30,082||)||(14,943||)||(89,579||)||(39,030||)|
|Other income (expense):|
|Interest and other income||657||462||2,173||796|
|Change in fair value of warrants||96||451||540||63|
|Total other income (expense)||(2,754||)||176||(2,919||)||(631||)|
|Net loss per common share - basic and diluted||$||(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|
Source: Xeris Pharmaceuticals, Inc.