Xeris Pharmaceuticals Announces Fourth Quarter and Full Year 2018 Financial Results and Highlights Pipeline Progress
Continuing to execute commercial build and launch readiness for Gvoke HypoPen™
Advancing pipeline of preclinical and clinical development-stage products
Cash position of
“2018 was an important year for Xeris in which we completed a successful IPO, submitted an NDA to the
Full Year 2018 and Recent Business Highlights
- Strengthened the balance sheet: In addition to the net proceeds of
$88.9 millionfrom the IPO, Xeris raised an additional $55.6 millionin net proceeds in February 2019to support the commercial launch of Gvoke HypoPen, continued advancement of the pipeline, and other general corporate purposes.
- Gvoke HypoPen PDUFA goal
June 10, 2019: As previously announced, the U.S. Food and Drug Administration( FDA) accepted for review the NDA of Xeris’ lead product candidate, Gvoke HypoPen, for the treatment of severe hypoglycemia in people with diabetes. The FDAhas assigned a PDUFA goal date of June 10, 2019.
- Strengthened commercial organization and operations: Xeris has hired key commercial leadership personnel in areas of U.S. Marketing and Sales, Global Commercialization and Business Development to begin market preparation, launch readiness, ex-U.S. commercial plans and partnering.
- Additional Phase 3 clinical trial data released on Company’s ready-to-use glucagon: In
November 2018, the Company presented positive efficacy and usability data at the 18th Annual Diabetes Technology Meeting demonstrating the potential of the Xeris investigational glucagon pen as an alternative to currently marketed rescue systems, which require complex, multi-step preparation and administration processes.
- Initiated Phase 2 study of ready-to-use glucagon for post-bariatric hypoglycemia (PBH) (NCT03770637): The Company commenced a randomized, placebo-controlled, double-blind, two-treatment, 2-period, crossover study in-patient phase to be followed by a placebo-controlled, double-blind, parallel two-treatment outpatient phase. Xeris expects top-line data in the first half of 2019 from the in-patient portion of the study. The results from this trial are expected to help enable the evaluation of ready-to-use glucagon in a future Phase 3 clinical trial using a vial/syringe in an outpatient setting. (PBH can begin to occur one to eight years after gastric bypass surgery. These severe hypoglycemic episodes are characterized by extreme low blood sugar levels that occur two to three hours after a meal. The etiology appears to be excessive insulin secretion in response to the meal.)
- EMA grants Orphan Drug Designation for investigational ready-to-use glucagon for the treatment of non-insulinoma pancreatogenous hypoglycaemia syndrome (NIPHS): NIPHS is a spectrum of metabolic conditions, which includes post-bariatric hypoglycemia (PBH). The EU orphan designation is associated with a 10-year commercial exclusivity for this indication.
- Completed Phase 2 clinical trial in congenital hyperinsulinism (CHI) (NCT02937558): In this Phase 2 trial, continuous subcutaneous glucagon infusion (CSI Glucagon) within the tested dose range was observed to directly reduce glucose infusion rates to a large and clinically meaningful extent when used as a sole therapy. Xeris expects results from this trial to support its efforts to evaluate CSI Glucagon in the context of a Phase 3 outpatient study, which the Company anticipates initiating in the first half of 2019. (CHI is a very rare disease that causes severe, persistent hypoglycemia in newborn babies and children. Common symptoms include irritability, sleepiness, lethargy, excessive hunger, and rapid heart rate. More severe symptoms such as seizures and coma can occur with a prolonged or extremely low blood sugar level.)
- Xeris room-temperature liquid stable glucagon used in dual-hormone closed-loop system: In
August 2018, Xeris announced that OHSU School of Medicine and OHSU Harold Schnitzer Diabetes Health Centerin Portland, Oregonare conducting a clinical trial with a dual-hormone artificial pancreas using Xeris’ ready-to-use liquid glucagon to evaluate a new closed-loop algorithm before and after exercise. OHSU is expected to report top-line results from this trial in the first half of 2019. Based on these results, the Company expects to move forward with a clinical program for a bi-hormonal artificial pancreas closed-loop system. (The artificial pancreas is a technology in development to help people with diabetes automatically control their blood glucose level by providing the substitute endocrine functionality of a healthy pancreas.)
- Xeris featured as one of the top diabetes companies for 2018 by MedTech Outlook magazine
- Xeris’ senior management will be participating in the following upcoming investor conferences:
Needham & Co.Annual Healthcare Conference on April 9-10, 2019in New York City RBC Capital Markets Global Healthcare Conferenceon May 21-22, 2019in New York City
- Jefferies 2019 Global Healthcare Conference on
June 4-7, 2019in New York City
Fourth Quarter and Full Year 2018 Financial Highlights
Cash position: As of
Research and development (R&D) expenses: R&D expenses for the fourth quarter and full year 2018 were
Selling, general and administrative (SG&A) expenses: SG&A expenses for the fourth quarter and full year 2018 were
Net loss: For the fourth quarter and full year 2018, Xeris reported a net loss of
Xeris is a specialty pharmaceutical company leveraging its novel 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
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)|
|Three Months Ended
|Twelve Months Ended
|Cost of revenue||-||-||42||4|
|Research and development||12,390||6,578||40,654||20,166|
|Selling, general and administrative||8,725||3,098||21,113||8,015|
|Expense from operations||21,115||9,676||61,767||28,181|
|Loss from operations||(20,314)||(9,209)||(59,344)||(26,629)|
|Other income (expense):|
|Change in fair value of warrants||133||(14)||196||(46)|
|Total other income (expense)||(105)||63||(736)||75|
|Net loss per common share - basic and diluted||$||(0.98)||$||(4.47)||$||(4.99)||$||(13.09)|
|Weighted average common shares outstanding,
basic and diluted
|XERIS PHARMACEUTICALS, INC.|
|CONDENSED BALANCE SHEETS|
|December 31, 2018|
|December 31, 2017|
|Cash and cash equivalents||$||45,716||$||42,045|
|Accounts receivable, net||2,869||1,199|
|Prepaid expenses and other current assets||2,397||809|
|Total current assets||117,899||44,053|
|Property and equipment, net||2,034||788|
|Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)|
|Deferred grant awards||232||234|
|Total current liabilities||10,172||4,860|
|Long-term debt, net of unamortized deferred costs||31,890||-|
|Other long-term liabilities||2,560||90|
|Total convertible preferred stock||-||97,878|
|Total stockholders' equity (deficit)||75,406||(57,830)|
|Total liabilities, convertible preferred stock and stockholders' equity (deficit)||$||120,028||$||44,998|
Source: Xeris Pharmaceuticals, Inc.