RALEIGH, N.C., April 20 /PRNewswire/ -- CLOSURE Medical Corporation
(Nasdaq: CLSR), a medical tissue cohesive products company, today announced
that total revenues for the first quarter ended March 31, 1998 were $770,000
compared to $208,000 for the quarter ended March 31, 1997. The net loss for
the 1998 quarter was $1.9 million, or ($.15) per share, compared to a net loss
of $1.5 million, or ($.12) per share in the corresponding 1997 period.
Cash and cash equivalents and total investments were $22.3 million at
March 31, 1998 compared to $24.5 million at December 31, 1997.
On January 30, 1998 the General and Plastic Surgery Devices Panel, a Food
and Drug Administration (FDA) advisory committee, unanimously recommended
"approval with conditions" of DERMABOND* as a wound closure device. DERMABOND
topical skin cohesive is based on CLOSURE's proprietary cyanoacrylate
technology.
In recommending approval of the Closure PMA, The Advisory Panel reviewed
an 818 patient ten-center clinical study designed to demonstrate that
DERMABOND topical skin cohesive is a safe and effective alternative to topical
sutures used in the closure of certain incisions and lacerations. Procedures
performed in the clinical trials included emergency lacerations, minimally
invasive puncture sites, plastic and reconstructive surgeries, and general
surgical incisions. The trials demonstrated DERMABOND topical skin cohesive
to be at least equivalent to nonabsorbable 5.0 or smaller diameter sutures,
staples or adhesive strips/tapes in wound closure, wound healing, cosmetic
outcome and infection rate and also demonstrated that the use of DERMABOND
topical skin cohesive substantially reduced procedure time.
"The panel recommendation was a historic milestone for our Company, and we
are pleased that our work and advancement toward the introduction of tissue
cohesives for wound closure in the U.S. has received this important
validation," said Robert Toni, President and Chief Executive Officer. "We are
working closely with the FDA to complete the last steps necessary for
commercialization."
CLOSURE Medical Corporation, headquartered in Raleigh, North Carolina,
develops, manufactures and commercializes medical tissue cohesive products
based on its proprietary cyanoacrylate technology. CLOSURE's nonabsorbable
tissue cohesive products may be used to replace sutures and staples for
certain topical wound closure applications, while its absorbable tissue
cohesive products can potentially be used as surgical sealants and tissue
cohesives for internal wound closure and management. Currently marketed
nonabsorbable tissue cohesive products include DERMABOND* topical skin
cohesive, which is used to replace sutures and staples for closure of certain
lacerations and incisions; OCTYLDENT* cohesive, which is used as an adjunct in
the treatment of adult periodontal disease; and the NEXABAND* line of topical
tissue cohesives, which are used in veterinary wound closure and management.
*DERMABOND is a Trademark of Ethicon, Inc.; OCTYLDENT and NEXABAND are
registered Trademarks of CLOSURE Medical Corporation.
This release contains certain forward-looking statements which involve
known and unknown risks, delays, uncertainties or other factors not under the
Company's control which may cause actual results, performance or achievements
of the Company to be materially different from the results, performance, or
other expectations implied by these forward-looking statements. These factors
include, but are not limited to, the early stage of commercialization of the
Company's products; scale-up of manufacturing processes; the need for
regulatory approval and effects of governmental regulation; technological
uncertainties; dependence on marketing partners; and dependence on patents and
trade secrets, as well as those detailed in the Company's Annual Report on
Form 10-K for the year ended December 31, 1997 and filed with the Securities
and Exchange Commission.
CLOSURE Medical Corporation
Statement of Operations
(Unaudited)
(In thousands, except per share data)
Three Months
Ended March 31,
1998 1997
Product sales $770 $208
License and product development revenues -- --
Total revenues 770 208
Cost of products sold 534 151
Gross profit and license and product development
revenues 236 57
Research, development and regulatory
affairs expenses 1,358 750
Selling and administrative expenses 1,100 1,062
Total operating expenses 2,458 1,812
Loss from operations (2,222) (1,755)
Interest expense (88) (1)
Investment and interest income 354 260
Net loss $ (1,956) $(1,496)
Shares used in computation of net loss per
share-basic and diluted 13,252 12,210
Net loss per share-basic and diluted $(0.15) $(0.12)
CLOSURE Medical Corporation
Balance Sheet
(In thousands, except for share data)
March 31, December 31,
1998 1997
Assets (Unaudited)
Current assets:
Cash and cash equivalents $4,821 $7,277
Short-term investments 13,367 14,417
Accounts receivable 431 1,226
Inventories 538 347
Prepaid expenses 361 367
Total current assets 19,518 23,634
Furniture, fixtures and equipment, net 5,821 3,694
Restricted investments 1,539 1,517
Long-term investments 2,579 1,298
Intangible assets, net 376 276
Total assets $29,833 $30,419
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $1,342 $ 478
Accrued expenses 1,487 2,598
Deferred revenue 2,025 2,019
Capital lease obligations 98 155
Current portion of long-term debt 350 350
Total current liabilities 5,302 5,600
Capital lease obligations 1,251 1,250
Long term debt less current portion 2,650 1,150
Total liabilities 9,203 8,000
Stockholders' Equity:
Preferred Stock, $.01 par value. Authorized
2,000,000 shares; none issued or outstanding. -- --
Common Stock, $.01 par value. Authorized
35,000,000 shares; issued and outstanding
13,251,681 shares. 133 132
Additional paid-in capital 46,149 46,058
Accumulated deficit (25,031) (23,075)
Deferred compensation on stock options (621) (696)
Total stockholders' equity 20,630 22,419
Total liabilities and stockholders' equity $29,833 $30,419
SOURCE CLOSURE Medical Corporation
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CONTACT:
Robert V. Toni, President & CEO, or J. Blount
Swain, CFO, both of CLOSURE Medical Corporation, 919-876-7800; or
General Info, Paul G. Henning, Analyst Info, Brian Gill, or Media
Info, Deanne Eagle, all of The Financial Relations Board,
212-661-8030
NOTE TO EDITORS: To receive CLOSURE's latest news release and
other corporate documents via FAX -- at no cost -- dial
1-800-PRO-INFO. Use Company's ticker-CLSR.
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