Highlights:
- Nine month revenues rise 19% to $5.7 million vs. $4.8 million last year.
- Nine month net loss narrows to $2.9 million or $0.43 per share,
vs. $3.7 million, or $0.57 per share last year.
- TAS(TM) analyzer and test card sales up 99% in the nine months of
1997 vs. last year.
- Company proves feasibility for test to monitor new sepsis drug
under development by Eli Lilly
Financial Summary Table
Nine Three
Months Ended Months Ended
9/30/97 9/30/96 9/30/97 9/30/96
Net revenue $5,720,155 $4,795,543 $1,677,003 $1,571,765
Net loss ($2,874,008) ($3,749,451) ($1,448,844) ($1,311,454)
Net loss per share ($0.43) ($0.57) ($0.22) ($0.20)
Weighted average common
shares outstanding 6,725,959 6,555,948 6,733,452 6,570,287
RALEIGH, N.C., Oct. 28 /PRNewswire/ -- Cardiovascular Diagnostics, Inc.
(Nasdaq: CVDI) announced today that net revenue for the nine months ended
September 30, 1997 rose approximately 19% to $5.7 million compared to
approximately $4.8 million last year. Contributing to these results were
sales of the Company's Thrombolytic Assessment System (TAS(TM)) analyzer and
test cards, which rose by $1.2 million, or 99% to $2.4 million compared to
last year's nine month period.
Revenues from the Company's Coeur Labs subsidiary declined 8% compared to
the nine months of 1996, due to reduced European sales of manifolds and
syringes in the first two quarters of the year, which was caused chiefly by
increased competition during that period.
Net revenue for the third quarter ended September 30, 1997 rose
approximately 7% to $1.7 million compared to approximately $1.6 million for
the same period in 1996. The increased revenue for the third quarter of 1997
was the result of a 9% increase in syringe sales for Coeur Labs during the
quarter due to a major customer securing a contract with Premier.
Operating expenses for the nine months ended September 30, 1997 were
essentially flat compared to last year, at $5.3 million. Operating expenses
for the third quarter ended September 30, 1997 increased 4%, or $64,000, over
the same quarter in 1996. This rise was attributable to a 19% increase for
scientific staffing at CVDI and clinical trials expenses associated with the
Company's test card menu expansion and proving feasibility on collaboration
agreements. In addition, administrative staffing as well as related
facilities expenses for utilities and rent increased 16% from the same period
in 1996. These increases were offset by a 33% reduction in sales and
marketing expenses due to CVDI using Dade as its North American distributor.
Other income increased to $1.4 million for the nine months ended September
30, 1997 compared to $530,000 last year. This additional $830,000 was
provided by development income from certain collaboration agreements with
pharmaceutical companies. These agreements have been instrumental in
supporting CVDI's efforts for test card menu expansion.
The operating loss for the nine months ended September 30, 1997 was
$2.8 million compared to $3.7 million in last year's nine month period --
representing a 23% improvement over last year. The operating loss for the
third quarter ended September 30, 1997 was $1.4 million compared to
$1.3 million for the same period in 1996. Included in the operating loss are
legal fees related to the Boehringer Mannheim Corporation litigation of
$232,000 for the nine months ended September 30, 1997 and $110,000 for the
three months ended September 30, 1997, respectively.
CVDI reported an improvement in its net loss for the nine months ended
September 30, 1997, totaling $2.9 million, or $0.43 per share based on
6.7 million weighted average common shares outstanding, compared to a net loss
of $3.8 million, or $0.57 per share based on 6.6 million weighted average
common shares outstanding in the same period of 1996. The net loss for the
third quarter ended September 30, 1997 was $1.4 million, or $0.22 per share
based on 6.7 million weighted average common shares outstanding, versus a net
loss of $1.3 million or $0.20 per share based on 6.6 million weighted average
common shares outstanding in the third quarter of 1996.
Commenting on the Company's results, John Funkhouser, President of CVDI
said, "We are pleased that we were able to make several marked improvements in
our financial results for the nine months of 1997."
Market Overview and Discussion of Key Opportunities for CVDI While a
leader in rapid coagulation technology, CVDI is selling its TAS analyzer and
test cards into a transitioning market characterized by ongoing consolidation
of hospitals and diagnostic companies. For diagnostic companies to be
competitive in this changing market, new technologies and software offerings
are required. CVDI provides a unique technology capable of an expanded test
menu beyond its initial routine coagulation tests being distributed by Dade.
Commenting on the market, Mr. Funkhouser said, "While there certainly is
value-added in providing faster turnaround time for routine coagulation tests.
The central lab has historically paid a low price for the same tests. Only
those tests used in critical care situations have a need to be expedited.
However, the specialty tests developed to monitor new therapies for stroke,
cardiac infarctions and sepsis, command a high value added because the central
lab cannot offer rapid diagnostic tests that can influence these therapies.
This is CVDI's ultimate market -- and one we are pursuing aggressively.
"As a young technology company, it is important to seek appropriate
strategic partners with established distribution capabilities complementary to
CVDI's future test menu. It is not clear as diagnostic companies continue to
consolidate, how these companies will segment the market. The traditional lab
company is facing a shrinking market with competitive pricing for large
hospital alliance accounts, while the critical care companies are being asked
to provide greater 'actionable' information for tests traditionally offered by
the central lab. We believe that traditional lab companies must ultimately
have access to critical care product lines to sustain growth." Uncertain
market conditions demand that the Company continually review the effectiveness
of its distribution channels.
CVDI is currently in field trials for a comprehensive heparin management
test panel that would be used during open heart surgery procedures, as well as
a test to monitor thrombin inhibitors, a new class of anticoagulants under
development by Eli Lilly and Company (NYSE: LLY) ("Lilly"). Based on these
activities, by the end of 1998, CVDI hopes to increase its menu to 13 tests
and possibly to 23 tests by the end of 1999. Most of these are being designed
for critical care settings, where presently, no rapid test exists that allows
the physician to make timely therapeutic decisions. CVDI believes strongly
that rapid diagnostic capabilities improve patient care and turnover, thereby
reducing total hospital costs -- a major goal in today's healthcare
environment. Additionally, there is a market trend to obtain diagnostic
information faster, either through POC technologies or software offerings, to
effect therapy immediately. This trend is focused on providing "actionable"
diagnostics. Consequently, CVDI feels it is well positioned in its
development efforts to expand its menu of tests to monitor developmental drugs
with narrow therapeutic windows or short half-lives -- where rapid therapeutic
intervention is key.
An example of CVDI's specialty test emphasis is its collaboration with Eli
Lilly and Company. During the third quarter, CVDI completed its initial
milestone to prove feasibility for a test to monitor a drug in development at
Lilly for sepsis. The next phase of the test's development is the most
crucial as the test is used during field trials to collect data from actual
patient samples.
CVDI expects to adjust its formulations to compensate for any potential
interferences. Proving feasibility and demonstrating the ability of the test
to evaluate the levels of this sepsis marker in the targeted patient
population are the critical milestones in developing a dry chemistry, rapid
diagnostic test. This ongoing collaboration with Lilly is part of CVDI's
corporate strategy to provide rapid diagnostic tests for new developmental
drugs for a disease with narrow treatment windows.
CVDI's experience in collaborating with pharmaceutical companies also has
demonstrated a market for standardizing routine tests in large pharmaceutical
clinical trials. In particular, there is a need for rapid results that can be
standardized across numerous clinical sites to expedite studies and FDA
submissions. With TAS, CVDI is in a strong position to take advantage of a
technology platform that has the potential to perform a variety of rapid
coagulation tests in many hospital settings.
CVDI believes that as its test menu is expanded, and the TAS analyzer is
readily available, the demand created by specialty tests will augment the
demand for routine tests. POC diagnostics requires hospitals to change
behavior patterns and institute new controls for monitoring near patient
testing. While the merits of POC testing are positive, hospitals that are
consolidating have to make the behavior change a priority in an unsettled
environment. Drugs offering significant potential savings that require rapid
diagnostic testing provide the urgency to implement POC testing. CVDI
believes that expanding menu will create greater demand for individual tests
going forward.
Company Adds Key Management Positions
Most recently, CVDI announced that Dick Timmons, 52, and Peter Scott, 48,
have joined the Company as Vice President of Manufacturing and Vice President
of Quality Control, respectively. Mssrs. Timmons and Scott bring over
20 years, each, of experience in their respective areas to CVDI and are
expected to make major contributions to the Company as CVDI moves closer to
commercialization of TAS and begins to fulfill integrated health network
contracts which have, and will be, rewarded over the long-term.
Cardiovascular Diagnostics, Inc. develops, manufactures and markets
systems designed to deliver rapidly and accurately, blood test results at the
point-of-care ("POC"). CVDI's novel technology platform has allowed the
Company to develop a menu of diagnostic tests, including new specialty tests.
The Company believes that its Thrombolytic Assessment System ("TAS")
technology is the only POC system capable of monitoring both the formation and
dissolution of blood clots -- a critical factor in treating heart attacks,
strokes and a variety of other medical conditions.
To receive CVDI's latest news release and other corporate documents via
FAX- no cost - dial 1-800-PRO-INFO. Use company's ticker, CVDI. Or visit The
Financial Relations Board's web site at http://www.frbinc.com .
This press release contains forward-looking statements regarding future
events and the future performance of Cardiovascular Diagnostics that involve
risks and uncertainties that could cause actual results to differ materially
from those projected in the forward-looking statements. Information
concerning factors that could cause actual results to materially differ from
those in the forward-looking statements is contained in the Company's SEC
filings, including Form 10-K, Form 10-Q and Form 8-K reports.
CARDIOVASCULAR DIAGNOSTICS, INC.
SELECTED FINANCIAL SUMMARY
CONSOLIDATED INCOME STATEMENTS
Three Months Ended Nine Months Ended
September 30, September 30, September 30, September 30,
1997 1996 1997 1996
Net sales $1,677,003 $1,571,765 $5,720,155 $4,795,543
Cost of goods sold1,483,662 1,257,277 4,433,757 3,747,825
Gross profit 193,341 314,488 1,286,398 1,047,718
Operating expenses1,816,635 1,752,662 5,254,105 5,271,202
Litigation expenses 109,598 0 231,668 0
Operating loss (1,732,892) (1,438,174) (4,199,375) (4,223,484)
Other income 298,321 145,901 1,368,186 531,576
Loss before
income taxes (1,434,571) (1,292,273) (2,831,189) (3,691,908)
Provision for
income taxes (14,273) (19,181) (42,819) (57,543)
Net loss ($1,448,844) ($1,311,454) ($2,874,008) ($3,749,451)
Net loss per share ($0.22) ($0.20) ($0.43) ($0.57)
Weighted average
common shares
outstanding 6,733,452 6,570,287 6,725,959 6,555,948
CONSOLIDATED BALANCE SHEETS
September 30, December 31,
1997 1996
Cash and investments $4,158,783 $8,689,647
Current assets $5,063,878 $12,198,120
Total assets $15,608,362 $18,351,355
Current liabilities $692,507 $616,030
Total liabilities $751,026 $683,017
Total shareholders' equity $14,857,336 $17,668,338
Total liabilities and equity $15,608,362 $18,351,355
SOURCE Cardiovascular Diagnostics, Inc.
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CONTACT: John Funkhouser, President, CEO, or Denise Hobbs, VP, Finance & Administration, of Cardiovascular Diagnostics, 919-954-9871; General - Paula Schwartz, 212-661-8030, or Analyst - Kathy Brunson, 312-266-7800, both of The Financial Relations Board
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