Given Imaging Announces Third Quarter 2002 Results
Fourth consecutive quarter of increased revenues30 October 2002 - Yoqneam, Israel - Given Imaging Ltd. (NASDAQ:GIVN), today announced revenues of $7.5 million for the third quarter of 2002, representing an increase of 480% over revenues in the third quarter of 2001 and the fourth consecutive quarter of increased revenues. The third quarter also represents the fourth full quarter of sales for the Company for both the U.S. and European markets following FDA clearance of the GivenŽ Diagnostic Imaging system in August 2001 and clearance to affix the CE-mark in Europe in May 2001.
On a geographic basis, sales of the Given System in the United States accounted for 58% of quarterly revenues. Seasonality negatively affected revenues both in Europe and the United States. The geographic breakdown of third quarter 2002 revenues is as follows:
(millions of US dollars)
United States $4.3
Europe $1.5
ROW $1.7Third Quarter 2002 Financials
Gross profit for the third quarter was 58.7% of revenues, compared to 54.4% in the second quarter of 2002. Net loss for the third quarter was $4.0 million, or $0.16 per share, compared to a net loss of $4.9 million, or $0.20 per share, in the second quarter of 2002.First Nine Month Results 2002
Revenues totaled $19.9 million for the first nine months of 2002. Gross profit was 55.4% of revenues. Operating expenses were $26.0 million. Net loss for the first nine months of 2002 was $14.6 million.Third Quarter Highlights
"Our third quarter sales reflect continued penetration of the Given System into the markets and our broad global coverage that reduced the impact of seasonality in certain markets," said Gavriel Meron, President and CEO of Given Imaging.During the third quarter, Given Imaging accomplished the following milestones:
- Sold more than 6,500 M2A capsules, of which more than 4,600 represent reorders. Cumulatively, more than 21,000 M2A capsules have been sold to date.
- Cumulative deliveries of the Given System reached more than 780 systems, with more than 350 systems installed in the United States.
- Received notification of insurance coverage statements from Horizon Blue Cross Blue Shield of New Jersey. In late September, Riverbend Government Benefits Administrator, a Medicare Fiscal Intermediary, issued a coverage statement for capsule endoscopy performed in an outpatient hospital setting for the states of New Jersey, Tennessee and in Rural Health Clinics in 44 other states. Currently, more than 35 million individuals in the United States have reimbursable access to the Given Diagnostic System, mainly for disorders associated with gastrointestinal bleeding from sources unidentified by other diagnostic methods. Coverage for other indications continues to be reimbursed on a case-by-case basis.
- Sponsorship by the American Society for Gastrointestinal Endoscopy (ASGE) of an inaugural Continuing Medical Education (CME) course on Capsule Endoscopy.
- Publication of several studies in peer-reviewed publications demonstrating the benefits of capsule endoscopy including a study in Gastrointestinal Endoscopy (September 2002, Volume 56, Number 3) which concluded that the M2A capsule identified small intestinal bleeding sites beyond the range of push enteroscopy. The study also concluded that capsule endoscopy provides excellent visualization of the small intestine, and is well tolerated and safe. A second study in Disease Management (Volume 5, Number 3, 2002) by investigators in the Office of Health Policy and Clinical Outcomes at Thomas Jefferson University, Philadelphia, concluded that the M2A capsule endoscope offers a potential net cost savings through earlier diagnosis of obscure intestinal bleeding. A third study appears in the September issue of Endoscopy (2002; 34 (9): 685 - 689) and concludes that the M2A capsule has a significantly superior diagnostic yield when compared to push enteroscopy.
- The Given System was granted regulatory approval in two major Far East markets, China and South Korea, where we appointed distributors 11 months and 8 months ago, respectively.
Recent Events
The Company recently participated in three scientific conferences at which more than 40 clinical presentations, 21 lectures and an off-site symposium took place, demonstrating the superiority of capsule endoscopy to traditional methods for diagnosing disorders of the small intestine. Conferences were:
- The American College of Gastroenterologists (ACG) held October 18-23 in Seattle attended by more than 3,000 gastroenterologists from the United States. Fifteen poster and 6 oral presentations were made on capsule endoscopy.
- United European Gastroenterology Week (UEGW) held October 19-23 in Geneva, Switzerland and was attended by more than 3,000 gastroenterologists, mainly from Europe. At this conference twenty-five clinical trials were presented including more than 900 patients.
- Australian Gastro Week (AGW) held October 13-20. Fifteen presentations on capsule endoscopy were presented, and an M2A Capsule Endoscopy Symposium with 80 attendees was held.
Third Quarter Webcast Information
Given Imaging will host a live webcast tomorrow, Thursday, October 31, 2002, at 10:00 am Eastern Time (5:00 pm Israel time) to discuss third quarter 2002 results. The presentation will be webcast through the Company's website www.givenimaging.com and will be available for rebroadcast on the website for 30 days.This press release contains forward-looking statements, including projections about our business, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, statements in the future tense, words such as "anticipates," "estimates," "expects," "intends," "plans," "believes," "intends" and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify such forward-looking statements. Those forward-looking statements are not guarantees of future performance and actual results could differ materially from our current expectations as a result of numerous factors, including but not limited to the following: changes in regulatory environment, our success in implementing our sales, marketing and manufacturing plan, protection and validity of patents and other intellectual property rights, the impact of currency exchange rates, the effect of competition by other companies, the outcome of future litigation, the reimbursement policies for our product from healthcare payors, quarterly variations in operating results, and other risks disclosed in our filings with the U.S. Securities Exchange Commission.