Given Imaging Announces First Quarter 2002 Results
Third consecutive quarter of increased revenues7/31/2002 - Yoqneam, Israel - Given Imaging Ltd. (NASDAQ:GIVN), today announced second quarter and first half results for the period ended June 30, 2002.
The Company announced revenues of $7.2 million for the second quarter of 2002, 38% higher than the first quarter of 2002. The second quarter represents the third full quarter of sales for the Company for both the U.S. and European markets following FDA clearance of the Given® Diagnostic Imaging system in August 2001.
(millions of US dollars)
United States $3.7
Europe $2.4
ROW $1.1
Second Quarter 2002 Financials
Revenues totaled $7.2 million for the second quarter. Gross profit was 54.4% of revenues, slightly higher than first quarter of 2002. The loss for the second quarter was $4.9 million compared to a loss of $5.8 million in the first quarter of 2002.Second Quarter Highlights
"The increase in second quarter sales indicates that gastroenterologists are recognizing the value of the Given System as a necessary diagnostic tool for their practice," said Dr. Gavriel Meron, President and CEO of Given Imaging, Ltd. "This is reinforced by the overwhelmingly positive response we received at Digestive Disease Week and sales of the Given System following this event. Additional reimbursement coverage in the second quarter is yet another sign that capsule endoscopy is becoming the new standard of care in the diagnosis of disorders of the small intestine."During the second quarter, Given Imaging accomplished the following milestones:
- Sold more than 6,900 M2A capsules, of which approximately 4,800 represent reorders.
- Reached an installed base for the Given System of more than 600, with 268 systems installed in the United States.
- Hosted a symposium at Digestive Disease Week on capsule endoscopy that was attended by more than 1,000 healthcare professionals. In addition, more than 48 clinical studies involving nearly 1,000 patients were presented by physicians including indications for Crohns disease, celiac disease, gastrointestinal tumors and pediatric use of the capsule, and reporting diagnostic yields of up to 80% for the M2A capsule.
- Created a joint venture in Japan with Marubeni Corporation, one of Japans largest trading corporations and Suzuken, Japans largest pharmaceuticals distributor to commercialize the Given System in Japan.
- Received notification of insurance coverage statements from California Medicare, Anthem Blue Cross and Blue Shield, Empire Medicare Services, Palmetto GBA and Triple-S. Recently, Noridian Healthcare and Oxford Health Plans also issued coverage statements. To date, more than 26 million individuals have reimbursable access to the M2A diagnostic system.
- Launched the M2A plus capsule following FDA clearance in May. The M2A plus allows physicians to pinpoint the exact location of a pathology.
- Launched OrderWIN system that allows physicians and hospitals in the United States to reorder capsules over the internet.
- Signed distribution agreements in 15 additional territories, bringing worldwide coverage to 46 countries as of the end of the quarter.
First Six Month Results 2002
Revenues totaled $12.4 million for the first half of 2002. Gross profit was 53% of revenues. Operating expenses were $17.4 million. The loss for the first six months of 2002 was $10.7 million.Other Developments
On a separate note, Given Imaging today also announced the appointment of current director Doron Birger as chairman of its board after accepting the resignation of current chairman Ami Erel. Mr. Birger is president of Elron Electronic Industries Ltd., (NASDAQ: ELRN), and has served as a director of Given Imaging since June 2000. Mr. Erel stated, "I am tendering my resignation so that I can concentrate on other investments. Since Given Imaging is no longer a development stage company and has been publicly traded in the United States for almost nine months, I believe that now is an appropriate time for me to step down. It has been a pleasure serving on the board of directors of Given Imaging, and I wish the company and its management every success in the future."In addition, following the resignation of Mr. Erel, the board announced the appointment of Dr. Chen Barir and Dr. Gavriel Meron as members of its board, thereby increasing the size of the board by one director to a total of nine directors. Dr. Barir is Chairman of Berman & Co. Trading and Investments Ltd. and subsidiaries, Galil Medical Ltd. and Sunlight Medical Ltd. He is also a director of Optonol Ltd. and Elron Electronic Industries Ltd. Dr. Barir holds a Master in Business Administration from the European Institute of Business Administration (INSEAD) in Fontainebleau, France and a Doctorate in Law and Economics from Harvard Law School in Cambridge, MA. Dr. Meron has served as the president and chief executive officer of Given Imaging since founding it in 1998.
Second Quarter Webcast Information
Given Imaging will host a live webcast tomorrow, Thursday, August 1, 2002, at 11:00 am Eastern Time (6:00 pm Israel time) to discuss second quarter 2002 results. The presentation will be webcast through the Companys website www.givenimaging.com.About Given Imaging
Given Imaging produces and markets the Given Diagnostic System, which features the M2A® Capsule Endoscope, a fundamentally new approach to examining the gastrointestinal tract. The system uses a disposable miniature video camera contained in a capsule that is ingested by a patient and delivers high quality color images in a painless and noninvasive manner. The test can be conducted while a patient continues normal daily activities. The system received clearance from the FDA in August 2001 and received permission to affix the CE mark in May 2001. The system is currently being marketed in more than 40 countries worldwide, including the USA, Canada, Europe, Central and South America and Asia. Thousands of patients suffering from diseases in the small intestine such as Crohn’s, celiac disease, unexplained abdominal pain with diarrhea, polyposis, intestinal tumors, iron deficiency anemia and obscure bleeding have already benefited from this innovative technology. For more information, visit www.givenimaging.com.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, and other risks disclosed in our filings with the U.S. Securities Exchange Commission.