– 2017 revenue increased 127% to $9.5 million, compared with $4.2 million in 2016 –
– Fourth quarter 2017 revenue increased 161% compared with same period in 2016 –
MODI’IN, Israel and MANASQUAN, N.J., March 12, 2018 (GLOBE NEWSWIRE) — Exalenz Bioscience Ltd. (TASE:EXEN), a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, today reported financial results for the fourth quarter and full year ended December 31, 2017.
Raffi Werner, CEO of Exalenz Bioscience, stated: “We are extremely pleased with our progress in 2017, which included a significant increase in sales for our laboratory system in the United States and achieving numerous important milestones related to the development of our technology in liver indications, a market with significant unmet need. We plan to build on this momentum in 2018 across all aspects of our organization and remain focused on uplisting to a U.S. exchange toward the end of the year.”
2017 Highlights and 2018 Objectives:
- The Company announced positive data from 257 patients with advanced non-alcoholic steatohepatitis (NASH) who participated in two parallel studies comparing the use of the BreathID 13C-methacetin breath test (MBT) to invasive measurement of portal pressure for the diagnosis of clinically significant portal hypertension (CSPH). Results demonstrated that the Company’s breath-test successfully diagnosed CSPH in NASH patients. The Company is preparing to meet with the FDA to discuss requirements for a potential marketing application for detecting CSPH in NASH in the United States in 2020.
- Exalenz expects to double its sales in 2018 to $17-19 million and forecasts revenue of $28-32 million in 2019. In addition, the Company anticipates a positive quarterly cash flow from operating activities in 2018.
- Exalenz continues to prepare for a listing on a major U.S. exchange by the end of 2018.
H. pylori segment highlights and updates
- Exalenz achieved substantial revenue growth due to the successful launch of the BreathID® Hp Lab System in the United States
- The Company continued to expand both Point-of-Care and lab sales in the United States, and other markets worldwide.
- Submitted an application to the China Food and Drug Administration (CFDA) for approval of the Company’s laboratory device in China. Assuming a positive response, Exalenz expects to receive approval in 2018.
Liver diagnostics segment highlights and updates:
- In January 2018, the Company published positive results of a company-sponsored clinical trial and a joint clinical trial with Galectin Therapeutics for the diagnosis of portal hypertension in 257 NASH patients.
- Exalenz continues to advance its two collaborations with Conatus Pharmaceuticals Inc., in which the BreathID device is used in clinical trials that are conducted by Conatus.
- The Company is in advanced discussions with a major pharmaceutical company for a potential clinical trial collaboration, which would be conducted with hundreds of potential NASH patients. The Company expects that this collaboration agreement will be signed this year.
Select 2017 Financial Results
Revenue for the fourth quarter of 2017 increased 161% to $3 million compared to the fourth quarter of 2016. The increase in revenue was primarily driven by penetration of the lab market in the U.S. as well as the company’s supply agreement with LabCorp. Revenue for the full year 2017 increased 127% to $9.5 million compared to the full year 2016.
Gross profit for the full year 2017 was $2.9 million, compared to $0.9 in the same period in 2016. The increase in gross profit was due mainly to the increase in sales.
Sales and marketing expenses were $2.4 million, or 25% of sales, during the full year 2017, compared to $2.2 million, or 51% of total sales in the full year 2016. In 2018, the Company intends to further reduce the ratio of sales and marketing expenses to total sales. The increase in selling and marketing expenses in 2017 was due mainly to increased penetration of the lab sector.
Operating loss was $5.0 million in the full year 2017, compared to an operating loss of $6.2 million in 2016. The EBITDA-adjusted operating loss (eliminating accounting effects and non-recurring expenses related to a PDUFA fee refund) amounted to $ 3.9 million for the full year 2017, compared to $5.4 million in the prior year.
Net loss amounted to $5.4 million in the full year 2017, compared to a net loss of US$ 6.3 million in the full year 2016.
The company’s complete financial results are available on the Tel Aviv Stock Exchange website.
More than 8 million people in the United States and Europe are living with advanced nonalcoholic steatohepatitis (NASH), the most severe form of non-alcoholic fatty liver disease (NAFLD) and a major risk factor for liver transplant and the development of primary liver cancer. The incidence of NAFLD is expected to increase more than 21% by 2030, with a concomitant increase of more than 63% in the incidence of NASH in the same period.
Clinically significant portal hypertension (CSPH), a complication of chronic liver disease and cirrhosis in which there is an increase in pressure in the vein that carries blood from the gastrointestinal tract to the liver, is closely associated with an increase in liver related morbidity and mortality. Detecting CSPH in patients with NASH is important for assessing the risk of developing liver complications, initiating therapeutic interventions to reduce portal hypertension and determining the need for additional procedures and/or monitoring. Portal pressure is measured by hepatic venous pressure gradient (HVPG), an invasive, complex and highly operator dependent procedure that exposes the patient to radiation and requires injection of contrast materials.
About Exalenz Bioscience
Exalenz Bioscience develops and markets diagnostic tests and monitoring systems that use the breath to diagnose and help manage gastrointestinal and liver conditions. The company’s flagship BreathID® Hp offers the most efficient and accurate test for detection of H. pylori bacteria, associated with various illnesses including gastric cancer, and is already in use in over 400 U.S. medical centers and major labs across the country. The BreathID 13C-methacetin breath test (MBT) is a sensitive, noninvasive, point of care tool that measures the microsomal function of the liver. Exalenz holds regulatory approvals in Europe, the United States, China and Israel for H. pylori detection and is currently evaluating additional applications of the BreathID platform, including MBT in the detection of CSPH in patients with NASH. Additional information is available at www.exalenz.com.
Projections and Forward-Looking Information:
This press release contains forward-looking statements with respect to plans, projections or future performance of the Company, the occurrence of which involves certain risks and uncertainties, some of which may not be under the control of Exalenz, including, but not limited to, changes in regulatory environment, Exalenz’s success in penetration of the laboratory market, including engaging national and regional laboratories, sales, marketing and manufacturing plans, protection and validity of patents and other intellectual property rights, and the effect of competition. The information in this document is a highly condensed summary of the highlights for the relevant period. For an appropriate full reporting and disclosure, the public is referred to the complete reports of the Company. Accordingly, the information provided in this document should not be relied upon in any form whatsoever in considering any investment in the Company or trading in its securities.