Creative BioMolecules Reports Second Quarter Results and Development Progress
PR Newswire, Monday, August 10, 1998 at 16:53
HOPKINTON, Mass., Aug. 10 /PRNewswire/ -- Creative BioMolecules Inc.
(NASDAQ:CBMI) today announced financial results for the second quarter of
fiscal 1998, ended June 30, 1998. Revenues were $2,281,000 and expenses were
$8,389,000, resulting in a net loss of $6,108,000 or $0.19 per share.
Comparable numbers for the quarter ending June 30, 1997 were revenues of
$3,916,000, expenses of $8,140,000 and a net loss of $4,223,000, or $0.13 per
share. For the six months ended June 30, 1998, the Company reported revenues
of $5,699,000 compared to $7,563,000 for the same period in 1997. Net loss
for the six month period ended June 30, 1998 was $11,027,000 or $0.33 per
share, compared to $7,972,000 or $0.24 per share in 1997. The differences
between 1998 and 1997 reflect primarily the timing of revenue recognition and
charges associated with a recent financing. Revenues have historically varied
on a quarterly basis. Revenues during the second quarter of 1998 included
funding from Stryker Corporation (AMEX:SYK) for work associated with the
PreMarket Approval application (PMA) for the OP-1 bone graft device and
preparations for the Pre-Approval Inspection, and funding from Biogen, Inc.
(NASDAQ:BGEN) for renal therapy research.
Expenses during the second quarter included activities related primarily
to the preparation of the Company's manufacturing facilities for the
Pre-Approval Inspection by the U.S. Food and Drug Administration, and the
continuing work with Stryker to support the PMA review activities. The
facility inspection will be conducted in association with the Pre-Market
Approval application process, which was initiated by Stryker in April of this
year.
In May of 1998, the Company completed a $25 million private placement of
convertible preferred stock. The Company plans to use the proceeds for
general purposes, including the development of new therapies based on its
proprietary technology in tissue and organ regeneration and repair. Accretion
on convertible preferred stock represents an amount equal to a 5% annual
conversion premium and the amortization of fees and expenses associated with
the placement.
Program Highlights
Orthopaedic Reconstruction
Activities related to Stryker's modular filing of a PMA application for
the OP-1 bone graft device are ongoing. Stryker began the modular PMA
submission to the FDA in April of this year. As the OP-1 device moves toward
commercialization, the Company's activities have been increasingly focused on
its role as the commercial manufacturer of the OP-1 bone graft device. The
Company anticipates that much of the time in its manufacturing facility during
the remainder of 1998 will be dedicated to manufacturing OP-1 devices for
additional clinical trials in orthopaedic reconstruction and inventory for the
anticipated product launch.
Renal Therapy
Biogen and the Company are conducting extensive preclinical studies to
understand questions associated with the development of OP-1 as a therapy for
acute and chronic renal failure. Following these studies, the Company and
Biogen expect to determine the appropriate future development plans and
timeline for the renal program. Data published in the May 7, 1998, edition of
The American Society for Clinical Investigation demonstrated that the
administration of OP-1 in animal models of acute renal failure preserved
kidney function and increased survival rate.
Stroke Therapy
Data published in the May 11, 1998, edition of NeuroReport demonstrated
that animals that received OP-1 at one and four days following stroke
experienced enhanced motor skill recovery compared to animals in the control
group. Most therapies currently in development for stroke attempt to limit
the size of the infarct and thus require intervention within hours of the
stroke onset. The published results demonstrate OP-1's ability to enhance
recovery when administered a full 24 hours after the stroke.
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.
This news release includes 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 course of the
research and development programs, including the achievement of development
milestones by the Company and completion of clinical testing, 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, Inc. and Subsidiary
Consolidated Statements of Operations
Three Months Ended Six Months Ended
June 30, June 30, June 30, June 30,
1998 1997 1998 1997
REVENUE:
Research and
development
contracts $1,800,615 $3,137,593 $4,803,474 $5,889,065
Manufacturing
contracts --- 161,687 --- 393,926
Interest and other 480,175 616,951 895,435 1,280,177
Total revenues 2,280,790 3,916,231 5,698,909 7,563,168
COSTS AND EXPENSES:
Research and
development 6,130,923 6,437,127 12,428,790 12,016,180
Cost of
manufacturing
contracts --- 112,720 --- 273,758
General and
administrative 2,171,785 1,536,937 4,138,395 3,139,853
Interest 86,633 52,882 159,143 105,354
Total costs
and expenses 8,389,341 8,139,666 16,726,328 15,535,145
NET LOSS (6,108,551) (4,223,435) (11,027,419) (7,971,977)
ACCRETION ON SERIES
PREFERRED STOCK 152,043 --- 152,043 ---
NET LOSS APPLICABLE
TO COMMON
STOCKHOLDERS ($6,260,594) ($4,223,435)($11,179,462) ($7,971,977)
BASIC AND DILUTED
LOSS PER SHARE ($0.19) ($0.13) ($0.33) ($0.24)
SHARES FOR BASIC
AND DILUTED 33,507,137 33,016,188 33,474,918 32,934,903
Balance Sheet Data
June 30,
1998
Cash, Cash Equivalents and
Marketable Securities $45,899,194
Total Assets $72,971,142
Total Stockholders' Equity $42,120,567
SOURCE Creative BioMolecules Inc.
-0- 08/10/98
/CONTACT: Karla MacDonald, Communications Specialist, 617-912-2953 or
Wayne E. Mayhew, III, V.P. and Chief Financial Officer, 617-912-2920 both of
Creative BioMolecules, Inc./ |
