WEST PATERSON, N.J., Dec. 12 /PRNewswire-FirstCall/ -- Tutogen Medical, Inc. , a leading manufacturer of sterile biological implant products made from human (allograft) and animal (xenograft) tissue, today announced financial results for the fiscal year and fourth quarter ended September 30, 2005.
For fiscal year 2005 the Company reported revenues of $31.9 million compared to $29.3 million in FY 2004; a 9 percent increase. The financial results of the fiscal year were impacted by one-time charges of:
-- $1.6 million for costs associated with the transfer of manufacturing capabilities from the Company’s German-based facility to its Alachua, Florida facility; -- an expense of approximately $500,000 related to the closing of the Company’s West Paterson, New Jersey corporate office, and -- a $1.3 million charge relating to the voluntary recall of all product units which utilized donor tissue received from BioMedical Tissue Services/BioTissue Recovery Services (BioMedical).
Giving full effect for these one-time charges, the Company reported a net loss of $6.6 million, or $0.42 per fully diluted share compared to net income of $1.5 million, or $0.09 per fully diluted share in fiscal year 2004. On a pro-forma basis, excluding the impact of these one-time events the Company reported a net loss of $3.2 million, or $0.21 per fully diluted share.
During the fiscal year, a number of significant goals were achieved that enhance the Company’s ability to return to profitability and to successfully execute its overall strategic plan. Product manufacturing capabilities to support sales within the United States have been transitioned from the Company’s facility in Neunkirchen, Germany to Alachua, Florida. A number of manufacturing and product management executives were added to the management team in fiscal year 2005 with the goal of increasing revenues and improving operating efficiencies. The company also is in the process of consolidating its U.S. operations by relocating its New Jersey headquarters to Alachua, Florida. The Company established a strategic goal to develop a number of new products for specific surgical applications that can drive increased sales for Tutogen products in the spine, dental and general surgery markets in 2006 and beyond.
Guy L. Mayer, chief executive officer of Tutogen Medical, said, “We have made substantial progress throughout fiscal 2005 in positioning Tutogen for consistent profitability in the years to come. The rapid expansion of our manufacturing capabilities in the U.S. to support domestic sales is an important step forward. We believe that we now have the manufacturing expertise and capacity to manufacture in Alachua all products for the growing U.S. market. Due to lower overheads and domestic sourcing of tissue we can produce products more efficiently and, consequently, more profitably than in previous years. We are also pleased to have successfully addressed regulatory issues in the European markets that set the stage for improved performance, particularly in France and Germany.”
Mr. Mayer continued, “Looking ahead, we anticipate expanded margins in our dental business by virtue of the reconfiguration of our marketing fee structure with our distribution partner in conjunction with the enhanced manufacturing capabilities at our Florida facility. The dental business continues to grow and we are optimistic that we will continue to achieve strong double-digit revenue growth in 2006 from combined sales of existing and new products. With regard to the spine business, we believe sales will be flat throughout the first half of the year, as our distribution partner works through currently stocked inventory. We expect spine sales to expand moderately in the second half of the year and accelerate from there with the introduction of new products.
“All in all, it has been a pivotal year in repositioning the Company for profitable growth. We have the products, the people, the distribution partners and the financial wherewithal to take the next step in our development.”
Tutogen Medical will conduct a conference call on Monday, December 12, 2005 at 11:00 AM EASTERN to review the results of the fiscal year. Interested parties can access the call by dialing (877) 407-9205 or (201) 689-8054 or by accessing the web cast at http://www.tutogen.com/investor.asp. A replay of the call will be available at (877) 660-6853 or (201) 612-7415, account number 286 and access number 180042 for 7 days following the call, and the web cast can be accessed at http://www.tutogen.com/investor.asp for 30 days.
About Tutogen Medical, Inc.
Tutogen Medical, Inc. manufactures sterile biological implant products made from human (allograft) and animal (xenograft) tissue. Tutogen utilizes its Tutoplast Process(R) of tissue preservation and viral inactivation to manufacture and deliver sterile bio-implants used in spinal/trauma, urology, dental, ophthalmology, and general surgery procedures. The Company’s Tutoplast(R) products are sold and distributed worldwide by Zimmer Spine and Zimmer Dental, subsidiaries of Zimmer Holdings, Inc. the Mentor Corporation, IOP, Inc. and through independent distributors and subsidiaries in the U.S. and Germany. For more information, visit the Company’s Web site at http://www.tutogen.com.
Forward Looking Statement Disclaimer: Certain statements in this news release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties, which may differ materially from those set forth in these statements. In addition, the economic, competitive, governmental, technological and other factors identified in the Company’s filings with the Securities and Exchange Commission could affect such results.
TUTOGEN MEDICAL, INC. and SUBSIDIARIES CONSOLIDATED FINANCIAL SUMMARY (in thousands except per share data) Three Months Ended Year Ended September 30, September 30, 2005 2004 2005 2004 REVENUE $ 7,952 $ 7,933 $31,860 $29,330 GROSS PROFIT 2,474 3,371 11,565 17,494 OPERATING EXPENSES 5,078 2,962 18,531 13,966 OPERATING (LOSS) INCOME (2,604) 409 (6,966) 3,528 FOREIGN EXCHANGE GAIN (LOSS) (93) (541) (173) (700) OTHER INCOME 41 39 77 98 INTEREST EXPENSE (79) (74) (130) (118) INCOME TAX EXPENSE (BENEFIT) (167) 200 (571) 1,305 NET (LOSS) INCOME $(2,568) $ (367) $(6,621) $ 1,503 BASIC (LOSS) EARNINGS PER SHARE FROM CONTINUING OPERATIONS $ (0.16) $ (0.02) $ (0.42) $ 0.10 DILUTED (LOSS) EARNINGS PER SHARE FROM CONTINUING OPERATIONS $ (0.16) $ (0.02) $ (0.42) $ 0.09 TUTOGEN MEDICAL, INC. and SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) Sept. 30, Sept. 30, 2005 2004 CURRENT ASSETS $19,191 $26,891 FIXED ASSETS, NET 6,612 6,138 DEFERRED INCOME TAXES 1,540 1,318 TOTAL ASSETS $27,343 $34,347 CURRENT LIABILITIES $ 9,859 $ 8,857 LONG TERM DEBT 630 827 DEFERRED DISTRIBUTION FEES 1,925 2,580 SHAREHOLDERS’ EQUITY 14,929 22,083 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $27,343 $34,347 Contacts: George Lombardi, Chief Financial Officer Lytham Partners, LLC Tutogen Medical, Inc. Institutional: Joe Diaz 973-785-0004, ext. 101 Retail: Joe Dorame glombardi@tutogen.com 602-889-9700
Tutogen Medical, Inc.
CONTACT: George Lombardi, Chief Financial Officer of Tutogen Medical,Inc., +1-973-785-0004, ext. 101, glombardi@tutogen.com; or Institutional:Joe Diaz, or Retail: Joe Dorame, +1-602-889-9700, both of Lytham Partners,LLC
Web site: http://www.tutogen.com/