Hopkinton, MA, March 11, 1998-Creative BioMolecules, Inc. (Nasdaq: CBMI) today announced financial results for the year ended December 31, 1997. The Company reported revenues of $15,433,000 and expenses of $32,085,000 for the full year, resulting in a net loss of $16,652,000, or $0.50 per share. The comparable figures for the year ended December 31, 1996 were revenues of $22,352,000, and expenses of $24,592,000 resulting in a net loss of $2,240,000, or $0.07 per share.
The decrease in revenues from 1996 to 1997 is due to a $10,000,000 one-time license fee from Biogen, Inc. received in December 1996, associated with the establishment of a renal disease therapy partnership. Revenues exclusive of the one-time licensing fee increased by 25%. The increase in expenses in 1997 resulted from expanded research and development activities, including preparation for commercial manufacturing and associated regulatory filings for the OP-1 Bone Graft Device.
For the three months ended December 31, 1997, the Company reported revenues of $3,551,000, and expenses of $8,686,000 compared to revenues of $12,738,000 and expenses of $7,210,000 for the three months ended December 31,1996. Net loss for the three month period ended December 31, 1997 was $5,135,000 or $0.15 per share, compared to net income of $5,528,000 or $0.16 per share for the three months ended December 1996.
The Company ended fiscal 1997 with $30,598,000 in cash and marketable securities.
During 1997, Creative BioMolecules prepared for the filing of a Pre-Market Approval (PMA) application for its lead product, the OP-1 Bone Graft Device. This product is in development with Stryker Corporation. A pivotal trial of the OP-1 Device was completed by Stryker in 1997 and preliminary results from this study were presented at scientific conferences during the year. Creative BioMolecules has established manufacturing facilities for the OP-1 Device and made investments during 1997 to prepare for regulatory review and the anticipated commercial launch.
Research and development revenues and expenses increased in part due to the initiation of the renal disease therapy partnership with Biogen. The Company also expanded its internal research in 1997 into new therapeutic areas including a preclinical stroke recovery program.
Creative BioMolecules, Inc. has established a substantial proprietary position in the field of morphogenic proteins, including OP-1. The Company’s morphogenic protein programs include a late stage development effort in orthopaedic reconstruction with Stryker Corporation, ongoing research to develop treatments for renal disease with Biogen, Inc., and the development of proprietary new therapies for stroke and other neurological disorders.
Creative BioMolecules, Inc. and Subsidiary |
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Consolidated Statements of Operations |
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Three Months Ended |
Twelve Months Ended |
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December 31, |
December 31, |
December 31, |
December 31, |
||||
1997 |
1996 |
1997 |
1996 |
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| REVENUE: | |||||||
| Research and development contracts | $3,041,000 |
$1,613,000 |
$12,693,000 |
$5,548,000 |
|||
| Manufacturing contracts | 0 |
272,000 |
394,000 |
4,485,000 |
|||
| License fees and royalties | 0 |
10,500,000 |
0 |
11,123,000 |
|||
| Interest | 495,000 |
353,000 |
2,331,000 |
1,174,000 |
|||
| Other | 15,000 |
0 |
15,000 |
22,000 |
|||
| Total revenues | 3,551,000 |
12,738,000 |
15,433,000 |
22,352,000 |
|||
| COSTS AND EXPENSES: | |||||||
| Research and development | 6,763,000 |
4,832,000 |
25,122,000 |
15,651,000 |
|||
| Cost of manufacturing contracts | 0 |
433,000 |
274,000 |
3,823,000 |
|||
| General and administrative | 1,865,000 |
1,891,000 |
6,473,000 |
4,901,000 |
|||
| Interest | 58,000 |
54,000 |
216,000 |
217,000 |
|||
| Total costs and expenses | 8,686,000 |
7,210,000 |
32,085,000 |
24,592,000 |
|||
| NET INCOME (LOSS) | ($5,135,000) |
$5,528,000 |
($16,652,000) |
($2,240,000) |
|||
| DILUTED INCOME (LOSS) PER SHARE | ($0.15) |
$0.16 |
($0.50) |
($0.07) |
|||
| SHARES FOR DILUTED INCOME (LOSS) | 33,325,910 |
34,361,821 |
33,078,120 |
30,062,334 |
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Balance Sheet Data |
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December 31, |
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1997 |
|||||
| Cash, Cash Equivalents and Marketable Securities | $30,598,000 |
||||
| Total Assets | $59,038,000 |
||||
| Total Stockholders' Equity | $52,709,000 |
||||
| Common Shares Outstanding | 33,392,582 |
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The statements in this news release that are not historical facts include forward-looking statements that involve risks and uncertainties. Factors which could cause actual results to differ from the Company’s expectations include, without limitation, the achievement of product development milestones by the Company, the impact of competitive products, the timely receipt of regulatory clearances required for clinical testing, manufacturing and marketing of products and the other risks and uncertainties detailed from time to time in the Company’s periodic reports.
Creative BioMolecules is a discovery and development company focused on proprietary protein-based therapeutics for human tissue regeneration and restoration. The Company’s therapeutics are based on proteins that act as signals in initiating and regulating the cellular events involved in cell and tissue formation.
NOTE: Creative BioMolecules’ latest press releases are available on the Internet at http://www.prnewswire.com or they may be requested by fax by calling 800-758-5804, extension 212213.
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For additional information on this news release, please contact the Company.