RALEIGH, N.C., Feb. 20 /PRNewswire/ -- CLOSURE Medical Corporation
(Nasdaq: CLSR), a medical device company engaged in developing, manufacturing
and commercializing tissue adhesive products, today announced financial
results for the fourth quarter and year ended December 31, 2000.
These results exclude the impact of the Company's adoption of Staff
Accounting Bulletin No. 101: Revenue Recognition in Financial Statements
(SAB 101). See "Effects of SAB 101" section below for a discussion of SAB
101's impact on the Company's 2000 financial results.
Total revenues for the fourth quarter of 2000 were $3,774,000, a
48% increase compared to $2,544,000 for the fourth quarter of 1999. The
net loss for the fourth quarter of 2000 was $31,000, or $0.00 per basic and
diluted common share, compared to a net loss of $773,000, or ($0.06) per basic
and diluted common share in the same period of 1999.
Revenues for the year ended December 31, 2000 totaled $13,076,000 compared
to $13,370,000 in the corresponding 1999 period. For the year ended December
31, 2000, the net loss was $1,537,000, or ($0.11) per basic and diluted common
share, compared to a net loss of $2,527,000, or ($0.19) per basic and diluted
common share for the same period of 1999.
The Company's performance in the fourth quarter of 2000 was its best since
the second quarter of 1999 and represents the fourth consecutive quarter of
revenue growth. Primarily all of the Company's revenues were from
DERMABOND(R) Topical Skin Adhesive which is used to replace sutures and
staples for the closure of certain lacerations and incisions. DERMABOND(R)
adhesive is distributed worldwide, in approximately 34 countries, by Ethicon,
Inc., a subsidiary of Johnson & Johnson. CLOSURE revenues for the full year
2000 were comparable to 1999 levels but were not representative of actual
market demand, nor of Ethicon's sales, of DERMABOND(R) adhesive. During 2000,
Ethicon continued to reduce its DERMABOND(R) adhesive inventory levels that
were built-up during 1999. With these inventory reductions and continued
market penetration of the DERMABOND(R) product in the emergency and operating
rooms, the Company expects 2001 revenues from DERMABOND(R) adhesive to be more
reflective of actual market demand.
As of December 31, 2000, cash, cash equivalents, and investments were
$11.8 million compared to $12.6 million at December 31, 1999.
Robert V. Toni, CLOSURE's President and Chief Executive Officer commented,
"Fiscal year 2000 set the stage for several potential milestones to be
achieved during 2001. In December 2000, we announced an agreement providing
Colgate Oral Pharmaceuticals, Inc., a subsidiary of Colgate-Palmolive Company,
with supply, distribution and development rights to the Company's
SOOTHE-N-SEAL(TM) canker sore relief technology. This is the first
over-the-counter (OTC) product for CLOSURE and the opportunities it presents
are exciting. We plan to further expand into the OTC market during 2001 with
LIQUIDERM(TM) liquid adhesive bandage, which was cleared by the Food and Drug
Administration (FDA) a couple of weeks ago. With this clearance, we
anticipate completing, by mid-year 2001, a new partnership agreement for the
distribution of LIQUIDERM(TM) adhesive setting up an early 2002 consumer
launch of the product."
SOOTHE-N-SEAL(TM) adhesive is the first cyanoacrylate medical device
approved by the FDA for the OTC consumer market. SOOTHE-N-SEAL(TM) adhesive
forms a protective barrier that shields oral ulcers from irritation due to
eating and drinking while providing immediate and long-term pain relief.
Additionally, the product utilizes the same proprietary technology as the
Company's professional product, DERMABOND(R) adhesive. SOOTHE-N-SEAL(TM)
adhesive is expected to be launched to the professional and consumer markets
in the first half of 2001 by Colgate Oral Pharmaceuticals, Inc.
LIQUIDERM(TM) adhesive is the first and only cyanoacrylate medical device
approved by the FDA for the OTC adhesive bandage market. LIQUIDERM(TM)
adhesive is painted on the wound, sealing it from dirt and germs, creating a
healing environment, which allows natural healing to take place quickly. As
the wound heals, the adhesive sloughs off naturally. CLOSURE is currently in
negotiations with a top tier marketing partner for rights to its OTC wound
care platform. The OTC wound care platform includes distribution rights to
all present and future products, including LIQUIDERM(TM) adhesive, except for
SOOTHE-N-SEAL(TM) adhesive.
Mr. Toni concluded by saying, "We are very pleased with the Company's
progress and achievements during 2000 and look forward to strengthening
shareholder value through continued growth of our core business, expansion of
our product pipeline, new partnership arrangements and obtaining profitability
in 2001."
EFFECTS of SAB 101
As required by the Securities and Exchange Commission, the Company adopted
SAB 101 in the fourth quarter of 2000. As a result, the Company recorded a
cumulative non-cash charge of $2,656,000, effective January 1, 2000, related
to previously recognized license and product development revenues. Of this
amount, $625,000 was recognized as product development revenues during fiscal
2000. The year ended December 31, 2000 net loss, including the effects of SAB
101, was $3,568,000 or $(0.27) per basic and diluted common share.
CLOSURE Medical Corporation, headquartered in Raleigh, North Carolina,
develops, manufactures and commercializes medical tissue adhesive products
based on its proprietary cyanoacrylate technology. CLOSURE's nonabsorbable
tissue adhesive products may be used to replace sutures and staples for
certain topical wound closure applications, while its internal tissue adhesive
products can potentially be used for internal wound closure and management.
Currently marketed nonabsorbable tissue adhesive products include
DERMABOND(R)* Topical Skin Adhesive, which is used to replace sutures and
staples for closure of certain lacerations and incisions and the NEXABAND(R)*
line of topical adhesives, which are used in veterinary wound closure and
management.
*DERMABOND(R) adhesive is a trademark of Ethicon, Inc.; SOOTHE-N-SEAL(TM)
canker sore relief is a licensed trademark of Colgate Oral Pharmaceuticals,
Inc.; and LIQUIDERM(TM) adhesive is a trademark of CLOSURE Medical
Corporation. NEXABAND(R) adhesive is a federally registered trademark of
CLOSURE Medical Corporation.
Individuals wishing to participate on the webcast, to be held at
4:30 PM EST today, can access the event at http://www.vcall.com . Please
allow extra time prior to the call to download the streaming media software
required for listening to the Internet broadcast. The online archive of the
broadcast will be available within 2 hours of the live call and will be
available for replay for 90 days.
CLOSURE Medical Corporation will be participating in the Lehman Brothers'
Global Healthcare Conference, to be held at Disney's Grand Floridian Resort
and Spa in Orlando, Florida from February 28 through March 2, 2001. CLOSURE
representatives are scheduled to present at 2:30 PM EST on March 2, 2001.
To receive CLOSURE's latest news release and other corporate documents via
fax, at no cost, call 1-800-PRO-INFO, use the Company's symbol CLSR. Or visit
the Financial Relations Board's website at http://www.frbinc.com .
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 products; the progress of its research and development programs for
future products; the need for regulatory approval and effects of governmental
regulation; technological uncertainties; the satisfactory conclusion of
negotiations with, and 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, 1999 filed with the
Securities and Exchange Commission.
CLOSURE Medical Corporation
Statements of Operations
(In thousands, except per share data)
Three Months Ended December 31,
2000 2000
Including Excluding
SAB 101 SAB 101 1999
(Audited) (Audited)
Product sales $3,774 $3,774 $2,544
License and product development
revenues 156 - -
Total revenues 3,930 3,774 2,544
Cost of products sold 1,094 1,094 932
Gross profit 2,836 2,680 1,612
Research, development and regulatory
affairs expenses 1,348 1,348 1,214
General and administrative expenses 1,490 1,490 1,304
Total operating expenses 2,838 2,838 2,518
Income (loss) from operations (2) (158) (906)
Interest expense (55) (55) (74)
Investment and interest income 182 182 207
Net income (loss) $125 $(31) $(773)
Net income (loss) per common share :
Basic and diluted $0.01 $0.00 $(0.06)
Shares used in computation of net
income
(loss) per common share:
Basic 13,418 13,418 13,345
Diluted 13,787 13,418 13,345
CLOSURE Medical Corporation
Statements of Operations
(In thousands, except per share data)
Twelve Months Ended December 31,
2000 2000
Including Excluding
SAB 101 SAB 101 1999
(Audited) (Audited)
Product sales $13,076 $13,076 $13,370
License and product development
revenues 625 - -
Total revenues 13,701 13,076 13,370
Cost of products sold 3,841 3,841 4,722
Gross profit 9,860 9,235 8,648
Research, development and regulatory
affairs expenses 5,853 5,853 6,296
General and administrative expenses 5,415 5,415 5,404
Total operating expenses 11,268 11,268 11,700
Income (loss) from operations (1,408) (2,033) (3,052)
Interest expense (235) (235) (344)
Investment and interest income 731 731 869
Net income (loss) before cumulative
effect of accounting change (912) (1,537) (2,527)
Cumulative effect of accounting
change (2,656) - -
Net income (loss) $(3,568) $(1,537) $(2,527)
Net income (loss) per common share
before cumulative
effect of accounting change:
Basic and diluted $(0.07) $(0.11) $(0.19)
Cumulative effect of accounting
change:
Basic and diluted $(0.20) $- $-
Net income (loss) per common share :
Basic and diluted $(0.27) $(0.11) $(0.19)
Shares used in computation of net
income
(loss) per common share:
Basic and diluted 13,390 13,390 13,324
CLOSURE Medical Corporation
Balance Sheet Data
(In thousands)
DECEMBER 31, DECEMBER 31,
2000 1999
Cash, cash equivalents and investments $11,832 $12,614
Working capital $8,462 $9,745
Total assets $22,139 $22,511
Long-term debt including current portion $1,487 $2,100
Total stockholders' equity $13,907 $16,625
SOURCE CLOSURE Medical Corporation
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CONTACT:
Robert V. Toni, President & CEO, or Benny
Ward, CFO, of CLOSURE Medical Corporation, 919-876-7800; or
General, Stuart Levine, Analysts, Cecelia Heer, or Media, Deanne
Eagle, of The Financial Relations Board, 212-661-8030
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