• Second quarter 2018 revenue increased 53% to $3.4 million, compared with $2.2 million in same period in 2017
  • The Company estimates total revenues for 2018 to reach $13 -14 million, an increase of 37 – 47% over 2017, and an additional increase of 25 – 35% in 2019
  • Successful June meeting with the FDA clarifying required data for PMA submission of BreathID test for diagnosing CSPH in NASH patients on schedule for first half of 2019

MODI’IN, Israel and MANASQUAN, N.J., Aug. 31, 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 three months ended June 30, 2018.

Second Quarter 2018 Highlights

  • The Company successfully completed a meeting with the U.S. Food and Drug Administration (FDA) to discuss requirements for a Premarket Approval (PMA) submission for use of the BreathID 13 C-methacetin breath test (MBT) to diagnose clinically significant portal hypertension (CSPH) in patients with advanced non-alcoholic steatohepatitis (NASH) in the United States. Based on the outcome of the meeting, Exalenz plans to use the data from the ongoing Phase IIb trial that is being conducted in collaboration with Conatus Pharmaceuticals, in conjunction with positive data from two parallel studies that were reported in January 2018, to form the basis of the PMA.  
  • The Company announced that its BreathID ® MBT will be evaluated in two Phase IIb clinical studies sponsored by Bristol-Myers Squibb.  
  • Exalenz announced that it confidentially submitted a draft registration statement to the U.S. Securities and Exchange Commission for a possible initial public offering of its ordinary shares.

“Our continued quarterly revenue growth reflects our success in penetrating the U.S. market for lab-based Helicobacter pylori testing and positioning our BreathID Urea Breath Test as a highly accurate, efficient and cost-effective approach to monitoring and diagnosing this clinically important infection,” stated Raffi Werner, CEO of Exalenz Bioscience. “Our successful meeting with the FDA regarding the data required to obtain a Premarket Approval submission for our second BreathID product was a critical milestone that keeps us on track for a regulatory submission in the first half of 2019 and anticipated product launch in 2020. Combined, these accomplishments strengthen our leadership position in the market for non-invasive diagnostic and monitoring tests.”

Select Second Quarter 2018 Financial Results

Revenue for the second quarter of 2018 increased 53% to $3.4 million compared to $2.2 million in the second quarter of 2017. The increase in revenue was primarily driven by penetration of the lab market in the U.S.

Gross profit for the second quarter of 2018 increased 77% to $1.2 million compared to $0.7 million in the same period in 2017. The increase in gross profit was due mainly to the increase in sales and the increase in the proportion of recurring revenue.

Research and development expenses for the second quarter 2018, net, were $1.0 million compared to $0.6 million in the second quarter 2017.

Sales and marketing expenses were $0.8 million, or 24% of total sales, during the second quarter 2018, compared to $0.6 million, or 26% of total sales in the second quarter 2017. The increase in selling and marketing expenses in 2018 was due mainly to increased penetration of the lab market. The Company expects the sales and marketing expenses, as a proportion of total sales, to continue to decrease over time due to the Company’s focus on selling to larger customers and the increase of recurring revenues.

General and administrative expenses for the second quarter 2018 were $0.7 million compared to $0.4 million in the second quarter 2017. The increase was due mainly to share-based compensation expenses.

Operating loss was $1.3 million in the second quarter 2018, compared to an operating loss of $0.9 million in the second quarter 2017. Adjusted EBITDA loss for the second quarter was $0.8 million, similar to the second quarter 2017.

Net loss amounted to $1.1 million in the second quarter 2018, compared to a net loss of $1.2 million in the second quarter 2017, or $0.04 per basic and diluted share in both periods.

Select Financial Results the Six Months Ended June 30, 2018

Revenue for the six months ended June 30, 2018 increased 67% to $6.7 million, compared to $4.0 million during the same period of 2017.

Gross profit for the six months ended June 30, 2018 was approximately $2.3 million, compared to $1.0 million during the same period of 2017, an increase of 133%. The increase in gross profit was due mainly to the increase in sales and the increase in the proportion of recurring revenue.

Research and development expenses, net, were $1.9 million for the six months ended June 30, 2018 compared to $1.7 million for the same period of 2017.

Sales and marketing expenses were $1.5 million, or 23% of sales for the six months ended June 30, 2018, compared to $1.2 million or 29% of sales for the same period in the prior year, an increase of $0.3 million. The Company expects the sales and marketing expenses, as a proportion of total sales, to continue to decrease over time due to the Company’s focus on selling to larger customers and the increase of recurring revenues.

General and administrative expenses were $1.2 million for the six months ended June 30, 2018, compared to $0.8 million in the same period in 2017. The increase was due mainly to share-based compensation expenses.

Operating loss for the six months ended June 30, 2018 was $2.3 million, compared to an operating loss of $2.8 million in the same period in 2017.

Net loss for the six months ended June 30, 2018 was $2.0 million, or $0.08 per basic and diluted share, compared to $3.0 million, or $0.12 per basic and diluted share, for the six months ended June 30, 2017.

The Company’s complete financial results are available on the Tel Aviv Stock Exchange website.

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 13 C-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.

Contact Information

Investor Relations

David Carey Lazar Partners 212-867-1768 dcarey@lazarpartners.com