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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________
FORM 10-K
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2000
or
[_] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Commission file number 0-21982
DIAMETRICS MEDICAL, INC.
(Exact name of registrant as specified in its charter)
MINNESOTA 41-1663185
(State or other jurisdiction of (IRS Employer Identification Number)
incorporation or organization)
2658 Patton Road
Roseville, Minnesota 55113
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (651) 639-8035
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act: Common Stock,
$.01 par value
Indicate by check mark whether the Registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
Registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
Yes X No _____
----
Indicate by check mark if disclosure of delinquent filers pursuant to Item
405 of Regulation S-K ((S)229.405 of this chapter) is not contained herein, and
will not be contained, to the best of Registrant's knowledge, in definitive
proxy or information statements incorporated by reference in Part III of this
From 10-K or any amendment to this Form 10-K. [_]
As of February 28, 2001, 26,725,416 shares of Common Stock were
outstanding, and the aggregate market value of the common shares (based upon the
closing price on said date on The Nasdaq National Market) of DIAMETRICS MEDICAL,
INC. held by non-affiliates was approximately $142,000,000.
Documents Incorporated by Reference
Parts of the Registrant's Annual Report to Shareholders for the year ended
December 31, 2000 are incorporated by reference in Part II hereof.
Parts of the Registrant's definitive Proxy Statement for the 2001 Annual Meeting
of Shareholders to be held on May 23, 2001 are incorporated by reference in Part
III hereof.
PART I
Unless the context otherwise indicates, all references to the
"Registrant," the "Company," or "Diametrics" in this Annual Report on Form 10-K
are to Diametrics Medical, Inc., a Minnesota corporation, incorporated in
January 1990, and where the context requires, its subsidiary, Diametrics
Medical, Ltd. ("DML").
The following federally registered trademarks of the Company are used
in this Annual Report on Form 10-K: Diametrics Medical, Inc.(R), IRMA(R)SL,
IDMS(R), Paratrend 7(R), Neotrend(TM), Neurotrend(TM) and Trendcare(R).
SureStep(R)Pro is a registered trademark of LifeScan, a Johnson & Johnson
company. Argyle(R) is a registered trademark of Tyco Ludlow.
Item 1. Business
Overview
The Company develops, manufactures and commercializes blood and tissue
analysis systems that provide immediate or continuous diagnostic results at the
point-of-patient care. Since its commencement of operations in 1990, the Company
has transitioned from a development stage company to a full-scale development,
manufacturing and marketing organization. The Company's goal is to be the world
leader in critical care blood and tissue analysis systems.
Blood and tissue analysis is an integral part of patient diagnosis and
treatment, and access to timely and accurate results is critical to effective
patient care. The Company believes that its blood and tissue analysis systems
will result in more timely therapeutic interventions by providing accurate,
precise and immediate or continuous test results, thereby allowing faster
patient transfers out of expensive critical care settings and reducing patient
length of stay. In addition, point-of-care testing can save money for hospitals
by reducing the numerous steps, paperwork and personnel involved in collecting,
transporting, documenting and processing blood and tissue samples. Moreover,
point-of-care blood and tissue analysis systems could ultimately eliminate the
need for hospitals to maintain expensive and capital intensive stat
laboratories.
The Company has two primary product platforms. The first platform
includes intermittent blood testing products based primarily on electrochemical
technology (the IRMA SL Blood Analysis System) and the second platform includes
continuous monitoring products based upon fiberoptic technology (the Trendcare
Continuous Blood Gas Monitoring Systems and the Neurotrend Cerebral Tissue
Monitoring System). Since its inception in 1990, the Company has developed,
manufactured and marketed the IRMA ("Immediate Response Mobile Analysis")
System, an electrochemical-based blood analysis system that provides rapid and
accurate diagnostic results at the point-of-patient care. The IRMA SL System
consists of a portable, microprocessor-based analyzer that employs single-use,
disposable cartridges to perform simultaneously several of the most frequently
ordered blood tests in a simple 90-second procedure.
The Company's first disposable electrochemical cartridge, introduced
in May 1994, performs three of the most frequently ordered blood tests for
critical care patients--the measurement of oxygen, carbon dioxide and acidity
(the "blood gases"). In June 1995, the Company expanded the IRMA System test
menu with the introduction of its electrolyte cartridge which measures inorganic
compounds including sodium, potassium and ionized calcium. The Company further
expanded its critical or "stat" test menu during the third quarter of 1996 with
the release of the second-generation system, IRMA SL, and the addition of the
measurement of hematocrit (i.e., the concentration of red blood cells in whole
blood) to its electrolyte cartridge. With these measurements and associated
calculated values, the IRMA SL System is able to perform the majority of the
critical or stat tests performed annually in the United States, comprising an
estimated $1.2 billion annual market. In 1997, the Company introduced its third-
generation system, IRMA SL Series 2000, and a new combination cartridge. The
combination cartridge is based upon the Company's "snapfit" cartridge design and
gives clinicians the ability to perform all critical blood gas, electrolyte and
hematocrit tests using one small blood sample and one single-use cartridge.
During 1998, the Company expanded the test menu of the IRMA System by
integrating the LifeScan (a Johnson & Johnson company) SureStepPro glucose strip
testing module into the analyzer. In 2000, the Company
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introduced its H4 single-use cartridge, which adds both chloride and blood urea
nitrogen ("BUN") to a test panel of sodium, potassium and hematocrit. Also under
development are additional blood tests for glucose, lactate and creatinine, and
a reusable version of the single use disposable cartridge, called IRMA-M.
In the fourth quarter of 1996, the Company expanded to its second product
platform with the introduction of a number of new products through the
acquisition of Biomedical Sensors, Ltd. ("BSL"), a Pfizer company. With the
acquisition of BSL (now known as Diametrics Medical, Ltd.), the Company acquired
a world-class continuous monitoring fiberoptic technology platform, which
complements the Company's existing electrochemical sensor intermittent testing
platform. This product line includes indwelling continuous monitoring systems,
consisting of a monitor, calibrator and intravascular disposable sensors.
Primary products include the Trendcare monitoring system, consisting of
Paratrend 7, which provides direct continuous monitoring of blood gases and
temperature in critically ill adult and pediatric patients, and Neotrend, which
provides direct continuous monitoring of blood gases and temperature in
critically ill newborn babies; and the Neurotrend cerebral tissue monitoring
system, which measures oxygen, carbon dioxide, acidity and temperature in brain
tissue and fluids as an indication of cerebral ischemia (i.e., deficient blood
supply to the brain) and hypoxia (i.e., inadequate oxygenation of the blood) in
patients with severe head injury and in patients undergoing surgical
intervention in the brain.
The Company has obtained clearances under Section 510(k) of the Food Drug
and Cosmetic Act (the "FDC Act") to market the IRMA SL System to test blood
gases, electrolytes, glucose, BUN and hematocrit in whole blood in hospital
laboratories and at the point-of-patient care, the Paratrend 7 and Neotrend to
monitor blood gases and temperature, and the Neurotrend system to monitor
oxygen, carbon dioxide, acidity and temperature in the brain. Additionally, in
the first quarter of 1998, the Company received clearance from the United States
Food and Drug Administration (the "FDA") to market the new IRMA-M multi-use
cartridge for its IRMA SL System. This cartridge is undergoing additional
development before it is released to the market. The Company has also gained CE
Mark approval for the IRMA SL System and the Paratrend 7, Neotrend and
Neurotrend continuous monitoring products, allowing these products to be
marketed in Europe.
In October 1998, the Company entered into an exclusive distribution
agreement with Codman & Shurtleff, Inc., a Johnson & Johnson company ("Codman"),
for worldwide market development and distribution of the Company's Neurotrend
monitoring system. The term of the agreement is for six years and is renewable
for two years. If minimum sales levels and marketing expenditure levels are not
achieved by Codman, certain payments will be due to the Company. Also, Codman
has the right of first refusal to market new continuous monitoring products
developed for the neuro market.
On June 7, 1999, the Company and Hewlett Packard Company ("HP") announced
that HP had signed an exclusive worldwide distribution agreement to market, sell
and distribute the Company's Trendcare continuous blood-gas monitoring systems
and the IRMA SL point-of-care blood analysis system. Under the terms of the
distribution agreement, the Company transferred full responsibility for
marketing, sales and distribution of these products to HP. The initial term of
the distribution agreement is three and a half years, with the option for
extensions. The distribution agreement also provides for minimum purchase
commitments, market development commitments, research and development funding
and royalty payments over the initial term of the agreement, as well as funding
of sales and marketing costs during a sales transition period in 1999. In
November 1999, HP assigned the distribution agreement, with all its related
rights and obligations, to Agilent Technologies, Inc. ("Agilent"), a leading
provider of test and measurement solutions and communications components.
Agilent was formed as a new company and subsidiary of HP in November 1999. HP
spun-off its ownership in Agilent to HP shareholders during 2000. In November
2000, Agilent announced the proposed sale of its healthcare business to Philips
Medical Systems, a division of Royale Philips Electronics. The sale transaction
is currently undergoing anti-trust review. The agreement between Agilent and the
Company is assignable to Philips with the Company's consent.
The Company's principal executive office is located at 2658 Patton Road,
Roseville, Minnesota 55113, and its telephone number is (651) 639-8035.
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Principal Products
Additional information regarding the Company's principal products is
provided below:
IRMA SL Series 2000 Blood Analysis System. The IRMA SL Series 2000 ("IRMA
SL System"), the third generation IRMA analysis system, was released in the
third quarter 1997, and provides the necessary foundation for current and future
product enhancements. The IRMA SL System is comprised of the IRMA SL analyzer
and a variety of electrochemical-based disposable cartridges which perform
select combinations of the most frequently ordered critical care diagnostic
tests of blood gases, electrolytes, hematocrit, chloride and BUN in a simple 90-
second procedure. The IRMA SL System also features electronic quality control,
as an alternative to aqueous quality control measures, which eliminates the need
for this costly and time-consuming process for many customers.
The IRMA SL analyzer is a battery or AC operated, portable,
microprocessor-based instrument weighing approximately four pounds, and includes
an on-board printer. The analyzer can be easily linked for data downloading
purposes to a hospital's laboratory or information system.
In conjunction with a marketing alliance reached in 1997 with LifeScan,
the Company incorporated blood glucose monitoring into the IRMA platform by
integrating LifeScan's SureStepPro Glucose Module into the IRMA SL System. The
Company began marketing the new integrated workstation during the first half of
1998.
IDMS - The IRMA Data Management System. IDMS is an advanced data
management software program that provides a comprehensive data management system
for point-of-care testing technologies. IDMS was initially released in 1996, and
an enhanced version was released in the third quarter of 2000. IDMS integrates
point-of-care diagnostic results from multiple IRMA devices and offers
convenient sorting, viewing and analysis capabilities for trending, reporting,
and archiving data. IDMS also seamlessly transfers point-of-care results to
other laboratory or clinical information systems.
Capillary Collection Device. The Capillary Collection Device was initially
introduced in 1996 and was enhanced in the third quarter of 2000 with a new
design. The Capillary Collection Device is a disposable component of the IRMA SL
System and provides the capability to collect and inject a capillary blood
sample. It is used with the IRMA SL System's single use cartridges to perform
blood gas, electrolyte, hematocrit and BUN testing. The capillary collection
device has applications in neonatal and pediatric intensive care units, and in
other situations where a capillary sample is preferred over an arterial or
venous sample.
Trendcare Continuous Blood Gas Monitoring System. The Trendcare Continuous
Blood Gas Monitoring System ("Trendcare"), consists of a monitor, patient data
module and calibration system which provides the platform for the Paratrend 7
and Neotrend intravascular disposable sensors (described below). The Trendcare
monitor displays trended patient data which allows constant surveillance of the
patient's condition, while the patient data module stores critical calibration
and patient information which moves with the patient during transfers. The real-
time patient information delivered by Trendcare can signal the onset of adverse
events and immediately identifies the impact of ventilator and resuscitation
therapy.
Paratrend 7. Paratrend 7 is the Company's second generation
sensor for its continuous monitoring products, and is the only multi-
parameter sensor for in-vivo direct continuous monitoring of blood gases
(oxygen, carbon dioxide and acidity) and temperature in critically ill
adult and pediatric patients. Inserted via an arterial catheter, the
sensor provides constant, precise measurement of vital blood gas
parameters. The new technology uses a fluorescent optical sensor for
monitoring oxygen, replacing the electrochemical version of its
predecessor. During 2000, the Company released a modified version of this
sensor, Paratrend 7+, which provides a dial-in introducer system as an
alternative to the telescopic introducer of
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Paratrend 7. The dial-in introducer allows faster placement of the sensor
into an arterial line, facilitating ease of use. The Company received FDA
clearance in October 1977 to market the Paratrend 7 in the United States
and received CE Mark approval in May 1998, allowing the system to be
marketed in Europe.
Neotrend. Based upon the fluorescent optical sensor technology
introduced with the Paratrend 7, Neotrend is the only multi-parameter
system for direct continuous monitoring of blood gases (oxygen, carbon
dioxide and acidity) and temperature in critically ill newborn babies,
delivering real-time respiratory and metabolic information at the
point-of-care. The Company received FDA clearance in December 1997 to
market Neotrend in the United States, and received CE Mark approval in May
1998, allowing the product to be marketed in Europe. Effective early 2001,
Neotrend is compatible with Argyle 3.7-Fr. and 5.0-Fr. umbilical artery
catheters, offering the convenience of use with this widely accepted and
utilized catheter brand.
Neurotrend Cerebral Tissue Monitoring System. The Neurotrend Cerebral
Tissue Monitoring System ("Neurotrend") is designed for direct continuous
monitoring of oxygen, carbon dioxide, acidity and temperature in brain tissue
and fluids as an indication of cerebral ischemia and hypoxia in patients with
severe head injury, and also for use during surgical intervention in the brain.
Neurotrend continuously measures these parameters through a small fiberoptic
sensor placed directly into the brain tissue or fluids. CE Mark approval was
received in the second quarter 1998, allowing the system to be marketed in
Europe, and the Company received clearance from the FDA in November 1999,
allowing the system to be marketed in the United States.
Regulatory Status
Human diagnostic products are subject, prior to clearance for marketing,
to rigorous pre-clinical and clinical testing mandated by the FDA and comparable
agencies in other countries and, to a lesser extent, by state regulatory
authorities. The Company and its products are regulated by the FDA under a
number of statutes including the FDC Act. The FDC Act provides two basic review
procedures for medical devices. Certain products may qualify for a submission
authorized by Section 510(k) of the FDC Act, wherein the manufacturer gives the
FDA a pre-market notification of the manufacturer's intention to commence
marketing the product. The manufacturer must, among other things, establish that
the product to be marketed is substantially equivalent to another legally
marketed product. Marketing may commence when the FDA issues a letter finding
substantial equivalence. A 510(k) clearance is subject to continual review, and
later discovery of previously unknown problems may result in restrictions on the
product's marketing or withdrawal of the product from the market. If a medical
device does not qualify for the 510(k) procedure, the manufacturer must file a
pre-market approval ("PMA") application. This procedure requires more extensive
prefiling testing than the 510(k) procedure and involves a significantly longer
FDA review process.
The Company has obtained clearances under Section 510(k) of the FDC Act to
market the IRMA SL System to test blood gases, electrolytes, hematocrit, glucose
and BUN in whole blood in hospital laboratories and at the point-of-patient
care. The IRMA-M cartridge, which allows multiple test panels to be performed on
a single cartridge, received clearance during 1998. Continuous monitoring
products which have been cleared under Section 510(k) include the monitoring
systems used with the Paratrend 7 sensor for direct continuous monitoring of
blood gases and temperature in adults and pediatric patients, the Neotrend
sensor for monitoring of blood gases and temperature in critically ill newborn
babies, and the Neurotrend sensor designed for direct continuous monitoring of
oxygen, carbon dioxide, acidity and temperature in brain tissue or fluids as an
indication of cerebral ischemia and hypoxia in patients with severe head injury
and also for use during surgical intervention in the brain.
Prior to clearance for marketing in Europe, the Company's products must
also meet regulatory standards outlined in several directives administered by
the European Union. Compliance with applicable directives and achievement of CE
Mark approval is based upon conformity assessment to the essential requirements
stated in the directive. In order for manufacturers to affix CE Mark to their
products, allowing the products to be marketed in Europe, they must follow the
conformity assessment procedures applicable to the classification of the
product, and prepare a declaration of conformity. Once gained, the CE Mark
requires updating when significant changes are made to the product, and the
Company's full quality system is subject to annual audit by its notified body in
the United Kingdom and in the United States.
The Company has gained CE Mark approval for all of its marketed products
that currently require it, including the Paratrend 7, Neotrend and Neurotrend
continuous monitoring products, and the IRMA SL System.
The Company's long-term business strategy includes development of
cartridges and sensors for performing additional blood and tissue chemistry
tests, and any such additional tests will be subject to the same regulatory
process. No assurance can be given that the Company will be able to develop such
additional products or uses on a timely basis, if at all, or that the necessary
clearances for such products and uses will be obtained by the Company on a
timely basis or at all, or that the Company will not be subjected to a more
extensive prefiling testing and FDA approval process. The Company also markets
its products in several foreign markets. Requirements vary widely from country
to country, ranging from
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simple product registrations to detailed submissions such as those required by
the FDA. Manufacturing facilities are also subject to FDA inspection on a
periodic basis and the Company and its contract manufacturers must demonstrate
compliance with current Quality System Regulations promulgated by the FDA.
The Company's intermittent testing products are affected by the Clinical
Laboratory Improvement Act of 1988 ("CLIA") which has been implemented by the
Health Care Financing Administration ("HCFA"). This law is intended to assure
the quality and reliability of all medical testing in the United States
regardless of where tests are performed. The regulations require laboratories
performing blood chemistry tests to meet specified standards in the areas of
personnel qualification, administration, participation in proficiency testing,
patient test management, quality control, quality assurance and inspections. The
regulations have established three levels of regulatory control based on test
complexity; "waived," "moderate complexity" and "high complexity." The tests
performed by the Company's IRMA SL System have been categorized under CLIA as
"moderately complex," which places this system in the same category as most
other commercially available blood gas and blood chemistry testing instruments.
The glucose test is categorized as a "waived" test, which places this test in
the same category as most other commercially available point-of-care glucose
testing systems. The Company's continuous monitoring products are not affected
by CLIA.
Research and Development
The Company owns two complementary technology platforms; an
electrochemical platform, on which IRMA intermittent testing products are based,
and a fiberoptic platform, on which the Paratrend 7, Neotrend and Neurotrend
continuous monitoring products are primarily based. The Company is pursuing
product line extensions from both of these core technology platforms.
The Company intends to continue to expand its cartridge and test menus
available on the IRMA SL System. The H4 single-use cartridge, which adds both
chloride and BUN to a panel of sodium, potassium and hematocrit, was released to
the market in 2000 and is intended for use by critical care centers to screen
patients for renal complications. In addition to the single-use cartridge, the
Company is developing a multi-use cartridge that will incorporate the Company's
current sensor and calibration technologies into products that can perform
multiple blood test panels on different patients over a period of days before
disposal. A multi-use system will serve the needs of high volume critical care
centers where rapid patient throughput and a low cost per test panel are
required. The multi-use module was initially scheduled for commercial release in
1999. However, feedback from customers has lead to further design enhancements
including automated operation, with global commercialization scheduled for 2002.
Also under development are new additions to the IRMA SL's cartridge blood test
menu, including glucose, lactate and creatinine. A single-use cartridge which
tests glucose and a panel of electrolytes is scheduled for commercial release in
late 2001. The Company believes that the IRMA SL System and related core
technologies provide a flexible platform which, with a limited amount of
additional development, will be capable of performing an even wider variety of
blood chemistry tests.
Development efforts also include further enhancements to the Company's
IRMA Data Management System ("IDMS"). IDMS is an advanced data management
software program that provides a comprehensive data management system for point-
of-care technologies. The new enhanced version of IDMS, scheduled for market
release in late March, permits the point-of-care coordinator to manage and
control the point-of-care program from one central location, improving the
overall efficiency of the clinical, laboratory and information technology
staffs, lowering the cost of operating the program, ensuring regulatory
compliance and reducing transcription errors.
The Company plans to continually improve the IRMA SL System through
software upgrades, manufacturing process improvements and equipment design
enhancements, based on the results of ongoing marketing studies and field
experience.
Development activities for the continuous monitoring platform during 2000
included a joint development effort with Cook Incorporated ("Cook") focused on
improving the access and ease of use of the Paratrend 7 with a non-kinking
catheter. Cook's new non-kinking catheter for use with Paratrend 7
6
received FDA clearance in March 2001, with commercial release in the United
States expected in the second quarter. Cook is now pursuing CE Mark approval,
which will allow the product to be marketed in Europe. Development efforts are
also focused on improving the bolt access and insertion devices for Neurotrend.
Additionally, studies are underway to apply continuous monitoring technology to
new neurological and tissue applications. The Company's future development plans
also include further expansion of the blood and tissue analysis test menu
available on the continuous monitoring platform.
Another major application initiative under development is the integration
of the Company's point-of-care intermittent testing and continuous monitoring
product lines into Agilent's patient monitoring platforms. These projects,
jointly under development by Agilent and the Company, include hardware, software
and disposable elements. The hardware component consists of a blood analysis
system in support of Trendcare continuous monitoring applications, and a blood
analysis system that supports IRMA intermittent testing applications. Both
systems are designed to plug directly into Agilent's patient monitoring
platform, providing an integration of technologies which will create a
communications interface that facilitates monitor display of both biochemical
and physiological information at the patient's bedside. The integrated blood
analysis systems which support intermittent testing and continuous monitoring
product line applications are scheduled for availability in the second half of
2001 and the first half of 2003, respectively.
The Company has incurred research and development expenses of
approximately $4,962,000, $4,847,000 and $6,466,000 for the years ended December
31, 2000, 1999 and 1998, respectively.
Sales and Marketing
The Company markets and distributes its products primarily through two
global partnerships with Codman and Agilent. The Company also continues to sell
direct to end-users in the veterinary market which is not subject to an
exclusive distribution agreement. Additionally, the Company's marketing strategy
is to pursue partnerships with market leaders who will help identify and promote
future applications in continuous tissue monitoring.
Effective October 1, 1998, the Company entered into an exclusive
distribution agreement with Codman for worldwide market development and
distribution of the Company's Neurotrend monitoring system. The Company's
exclusive distribution agreement with Agilent, initially entered into with
Hewlett Packard Company on June 7, 1999, provides for worldwide market
development and distribution of the Company's Trendcare continuous blood gas
monitoring systems and the IRMA SL blood analysis system. Information concerning
the Company's export sales is contained in the financial section of the
Company's Annual Report to Shareholders for the year ended December 31, 2000,
under note 14 of Notes to Consolidated Financial Statements, and is incorporated
herein by reference.
Prior to entering into the exclusive distribution agreements described
above, the Company's marketing efforts for its blood analysis systems focused on
acute care hospitals. Under the Company's new distribution agreements, near term
end-user sales of the Company's products are expected to continue to come from
hospital critical care departments where blood tests are frequently requested on
a stat basis. The Company's distributors' objectives will also include
penetration of smaller hospitals and alternate-site markets, such as emergency
medical facilities, home healthcare agencies, outpatient clinics, skilled
nursing homes and doctors' offices or clinics. The Company believes that the
advantages of its blood analysis and monitoring systems will help overcome the
possible reluctance of acute care hospitals to change standard operating
procedures for performing blood and tissue analysis or incur additional capital
expenses.
The Company's established arrangements with hospital systems, healthcare
facilities and other influential healthcare buying groups which established the
Company as a sole, preferred or dual source supplier of its blood analysis
systems are now administered by Agilent. The Company expects its distribution
partners to continue to enter into arrangements with buying groups and customers
with respect to purchases of its blood and tissue analysis systems.
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Manufacturing
The Company's manufacturing facilities support its intermittent testing
and continuous monitoring platforms and are located in Roseville, Minnesota and
High Wycombe, United Kingdom, respectively. The Company manufactures its IRMA
electrochemical thick-film cartridges in its Roseville, Minnesota facility.
Components for the Company's continuous monitoring sensors used in the Paratrend
7, Neotrend and Neurotrend products are sourced from a variety of outside
vendors, but the unique assembly and testing of the sensing elements is
performed in the Company's High Wycombe facility. The sub-assembly of external
plastic assemblies is sub-contracted to outside vendors. The Company uses
external manufacturers to produce a range of hardware items, including the
Trendcare and Neurotrend monitors and patient data module. The Company assembles
in-house the IRMA SL analyzer and the continuous monitoring calibrator at the
Roseville and High Wycombe facilities, respectively. These devices could be
manufactured by a number of microelectronics assembly companies, using primarily
off-the-shelf components. Software for the IRMA SL analyzer is developed and
maintained by the Company, and software for the continuous monitoring products
is jointly developed with an external source, with acceptance and validation
performed by the Company.
The majority of the raw materials and purchased components used to
manufacture the Company's products are readily available. Most of the Company's
raw materials are or may be obtained from more than one source. A small number
of these materials, however, are unique in their nature, and are therefore
single sourced. Plans are ongoing to add additional second sourcing where
appropriate.
The Company's manufacturing facilities include four clean rooms in
Roseville which range from Class 1,000 to Class 100,000, and two clean rooms in
High Wycombe, both rated as Class 10,000. The Company believes its current
facilities can support production of required cartridges and sensors for the
foreseeable future, without further significant capital investments.
The Company maintains a comprehensive quality assurance and quality
control program, which includes complete documentation of all material
specifications, operating procedures, maintenance and equipment calibration
procedures, training programs and quality control test methods. To control the
quality of its finished product, the Company utilizes ongoing statistical
process control systems during the manufacturing process and comprehensive
performance testing of finished goods.
The Company continues to successfully undergo required inspections of its
manufacturing facilities by the FDA (most recently in October 1998 and October
1999 for Roseville and High Wycombe facilities, respectively), and by the
British Standards Institution for the High Wycombe facility (most recently in
July 2000). As a result of these inspections, the Company's manufacturing
facilities and documentation and quality control systems are deemed satisfactory
and in compliance with Quality System Regulations.
Patents and Proprietary Rights
The Company has implemented a strategy of pursuing patent applications to
provide both design freedom and protection from competitors. This strategy
includes evaluating and seeking patent protection both for inventions most
likely to be used in its blood and tissue analysis systems and for those
inventions most likely to be used by others as competing alternatives.
For its intermittent testing platform, the Company currently maintains
four patents issued for its calibration technology, four patents related to its
sensor technology and four for companion technology. In addition, two patents
have been issued and maintained covering the IRMA SL analyzer and disposable
cartridge designs. Additionally, the Company has submitted patent applications
pertaining to an enzymatic sensor. Overseas, the Company has foreign patent
applications pending, filed under the Patent Cooperation Treaty, designating
various jurisdictions, including Canada, the major European countries, Brazil,
Australia and Japan, corresponding to one or more U.S. applications. The Company
maintains 16 foreign patents; two issued in the United Kingdom, two in Germany,
two in France, five in Canada and five in Japan.
8
As it relates to its continuous monitoring platform, the Company currently
maintains eight U.S. patents associated with the design and manufacture of its
sensor technology platforms, and has filed two patent applications. These
patents are at various patent process stages in the major European countries and
Japan.
Material patents have expirations ranging from the year 2006 to 2018. The
Company is not currently a party to any patent litigation.
The Company has federally registered the trademarks "IRMA SL," "Diametrics
Medical, Inc.," "Diametrics Medical, Incorporated," "IRMA Data Management System
(IDMS)," "Neocath," "Paratrend," "Tissutrak," "Paratrend 7+," "Neotrend,"
"Trendcare," and "Neurotrend."
Competition
The Company believes that potential purchasers of point-of-care blood and
tissue analysis systems will base their purchase decision upon a combination of
factors, including the product's test menu, ease of use, accuracy, price and
ability to manage the data collected. The Company is aware of one other
company, i-STAT, that is marketing a hand-held point-of-care blood analysis
system. The Company believes that the IRMA SL System possesses distinct
competitive advantages over i-STAT's products including ease of use, closed
instead of open handling of blood samples and room temperature instead of
refrigerated storage of reagents.
The Company also competes with companies that market near-patient multi-
use blood analysis systems. These companies include AVL Scientific Corporation,
Radiometer, Inc., Instrumentation Laboratories and Bayer (with their acquisition
of Chiron Diagnostics). However, the Company believes that to be successful in
the point-of-care market, a device must not only be able to perform a variety of
commonly ordered blood chemistry tests, but also be very portable to facilitate
ease of use at the patient's bedside.
The Company's blood analysis systems also compete with manufacturers
providing traditional blood analysis systems to central and stat laboratories of
hospitals. Although these laboratory-based instruments provide the same tests
available with the Company's products, they are complex, expensive and require
the use of skilled technicians. The Company believes that its blood analysis
systems offer several advantages over these laboratory-based instruments
including immediate or continuous results, ease-of-use, reduced opportunity for
error and cost effectiveness. The Company believes that its multi-parameter
continuous arterial blood gas and tissue monitoring systems are currently the
only products of their kind commercially available.
The Company's products are competitively priced with other point-of-care
product offerings and are lower in price than centralized testing labs when the
full cost of implementation is considered (i.e., equipment, maintenance,
facilities and trained lab personnel). Centralized testing labs also do not
provide the convenience and fast turnaround time for test results that point-of-
care products offer.
Many of the companies in the medical technology industry have
substantially greater capital resources, research and development staffs and
facilities than the Company. Such entities may be developing or could in the
future attempt to develop additional products competitive with the Company's
blood and tissue information systems. Many of these companies also have
substantially greater experience than the Company in research and development,
obtaining regulatory approvals, manufacturing and marketing, and may therefore
represent significant competition for the Company. There can be no assurance
that the Company's competitors will not succeed in developing or marketing
technologies and products that will be more effective or less expensive than
those being sold by the Company or that would render the Company's technology
and products obsolete or noncompetitive.
9
Executive Officers
Name Age Position
---- --- --------
David T. Giddings 57 President, Chief Executive Officer and
Chairman
Roy S. Johnson 48 Executive Vice President and
President and Managing Director of
Diametrics Medical, Ltd.
Laurence L. Betterley 47 Senior Vice President and
Chief Financial Officer
Mr. Giddings was appointed Chairman of the Board of Directors, President
and Chief Executive Officer of the Company in April 1996. Mr. Giddings was
formerly President and Chief Operating Officer of the United States operations
of Boehringer Mannheim Corporation ("BMC"), a U.S. subsidiary of Corange Ltd., a
private global healthcare corporation. He joined BMC in 1992 after a 26-year
career with Eastman Kodak Company, where he held a number of senior management
positions, including General Manager and Vice President of Marketing and Sales,
clinical products division. He also served as Vice President and General Manager
of Kodak's imaging information system group and of its printing and publishing
division.
Mr. Johnson joined the Company in November 1996 as an Executive Vice
President, and the President and Managing Director of Diametrics Medical, Ltd.
("DML"), a subsidiary of the Company established in conjunction with the
acquisition in November 1996 of Biomedical Sensors, Ltd. ("BSL"). DML markets a
line of indwelling monitoring systems for continuous blood and tissue assessment
of critically ill patients. Beginning in 1977, Mr. Johnson served in a number of
management positions for the predecessors of the BSL business, most recently as
President and Chief Executive Officer while it was a subsidiary of Orange
Medical Instruments, Inc. and later when it was an operating unit of Pfizer Inc.
Mr. Johnson started his career in 1974 with Burroughs Wellcome in pharmaceutical
production management and was the head of manufacturing in Burroughs' Sydney,
Australia subsidiary.
Mr. Betterley has been Senior Vice President of the Company since October
1996 and Chief Financial Officer since August 1996. Prior to this, he was with
Cray Research, Inc. in various management and financial positions including
Chief Financial Officer from 1994 to 1996, Vice President of Finance from 1993
to 1994 and Corporate Controller from 1989 to 1993. Cray Research develops,
manufactures and sells high performance computing systems used for computational
research.
Employees
As of December 31, 2000, the Company had a total of 154 full-time
employees, including 47 persons engaged in research and development activities.
None of the Company's employees are covered by a collective bargaining
agreement, and Diametrics believes it maintains good relations with its
employees.
Forward-Looking Statements
This Annual Report on Form 10-K and the Company's financial statements,
"Management's Discussion and Analysis of Results of Operations and Financial
Condition" in Item 7 and other documents incorporated by reference contain
"forward-looking statements" within the meaning of Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. These forward-looking statements represent our expectations or
beliefs, including, but not limited to, our current assumptions about future
financial performance, anticipated problems, and our plans for future
operations, which are subject to various risks and uncertainties. When used in
this Form 10-K and in future filings by the Company with the Securities and
Exchange Commission, in our press releases, presentations
10
to securities analysts or investors, in oral statements made by or with the
approval of an executive officer of the Company, the words or phrases
"believes," "may," "will," "expects," "should," "continue," "anticipates,"
"intends," "will likely result," "estimates," "projects," or similar expressions
and variations thereof are intended to identify such forward-looking statements.
However, any statements contained in this Form 10-K that are not statements of
historical fact may be deemed to be forward-looking statements. We caution that
these statements by their nature involve risks and uncertainties, certain of
which are beyond our control, and actual results may differ materially depending
upon a variety of important factors, including those described in Exhibit 99 to
this Form 10-K.
Item 2. Properties
The Company's principal properties are as follows:
Location of Use of Approximate Lease
Property Facility Square Footage Expiration Date
- ---------------- ------------------ -------------- ---------------
Roseville, Minnesota Manufacturing, research 43,300 February 2004
and development, sales,
marketing and administration
Malvern, Pennsylvania Research and development 2,000 March 2002
High Wycombe, Manufacturing, process 14,500 September 2005
United Kingdom engineering, purchasing
and distribution
High Wycombe, Sales, marketing and 5,500 January 2015 (1)
United Kingdom administration
High Wycombe, Research and development 6,000 April 2004 (2)
United Kingdom
(1) Lease can be terminated without penalty at the Company's sole
discretion in July 2002 and January 2005.
(2) Lease can be terminated without penalty at the Company's sole
discretion in April of 2001, 2002 and 2003.
The Company believes that its facilities are sufficient for its projected needs
through 2002.
Item 3. Legal Proceedings
The Company is currently not subject to any material pending or
threatened legal proceedings.
Item 4. Submission of Matters to a Vote of Security Holders
No matters were submitted to a vote of security holders during the
fourth quarter of the year ended December 31, 2000.
PART II
Item 5. Market for Registrant's Common Equity and Related Stockholder Matters
The Company's Common Stock, $.01 par value, trades on The Nasdaq
National Market under the symbol "DMED." The information contained under the
heading "Stock Information" on page 36 in the
11
Company's Annual Report to Shareholders for the year ended December 31, 2000
(the "Annual Report to Shareholders"), is incorporated herein by reference.
Item 6. Selected Financial Data
The information contained under the heading "Selected Five-Year
Financial Data" on page 13 in the Annual Report to Shareholders is incorporated
herein by reference.
Item 7. Management's Discussion and Analysis of Results of Operations and
Financial Condition
The information contained under the heading "Management's Discussion
and Analysis of Results of Operations and Financial Condition" on pages 13
through 18 in the Annual Report to Shareholders is incorporated herein by
reference.
Item 7.a. Quantitative and Qualitative Disclosures About Market Risk
The information contained under the heading "Market Risk" on page 17
in the Annual Report to Shareholders is incorporated herein by reference.
Item 8. Financial Statements and Supplementary Data
The information contained under the headings "Consolidated Statements
of Operations," "Consolidated Balance Sheets," "Consolidated Statements of
Shareholders' Equity and Comprehensive Loss," "Consolidated Statements of Cash
Flows" and "Notes to Consolidated Financial Statements" on pages 19 through 33
and "Report of Independent Auditors" on page 34 in the Annual Report to
Shareholders is incorporated herein by reference.
Item 9. Changes in and Disagreements with Accountants on Accounting and
Financial Disclosure
None.
PART III
Item 10. Directors and Executive Officers of the Registrant
Directors of the Registrant
The information contained under the heading "Election of Directors"
in the Company's definitive Proxy Statement for its 2001 Annual Meeting of
Shareholders to be held on May 23, 2001, which definitive Proxy Statement will
be filed within 120 days after the close of the fiscal year ended December 31,
2000 (the "Proxy Statement"), is incorporated herein by reference.
Executive Officers of the Registrant
See Part I, Item 1 of this Report for information on Executive
Officers of the Company.
The information contained under the heading "Compliance with Section
16(a) of the Securities Exchange Act of 1934" in the Proxy Statement is
incorporated herein by reference.
Item 11. Executive Compensation
The information contained under the heading "Executive Compensation"
in the Proxy Statement is incorporated herein by reference, except that,
pursuant to Item 402(a)(8) of Regulation S-K, the subsections under "Executive
Compensation" entitled "Report of Compensation Committee on Executive
Compensation" and "Comparative Stock Performance" provided in response to
paragraphs (k) and (l) of Item 402 are not incorporated by reference herein.
12
Item 12. Security Ownership of Certain Beneficial Owners and Management
The information contained under the heading "Security Ownership of
Certain Beneficial Owners and Management" in the Proxy Statement is incorporated
herein by reference.
Item 13. Certain Relationships and Related Transactions
The information contained under the heading "Certain Transactions" in
the Proxy Statement is incorporated by reference.
PART IV
Item 14. Exhibits, Financial Statement Schedules and Reports on Form 8-K
(a) 1. Financial Statements
The following consolidated financial statements of Diametrics Medical,
Inc., which are included in the Annual Report to Shareholders, are incorporated
by reference in Item 8 hereof:
Report of Independent Auditors
Consolidated Statements of Operations for each of the years in the three-
year period ended December 31, 2000
Consolidated Balance Sheets at December 31, 2000 and 1999
Consolidated Statements of Shareholders' Equity and Comprehensive Loss for
each of the years in the three-year period ended December 31, 2000
Consolidated Statements of Cash Flows for each of the years in the three-
year period ended December 31, 2000
Notes to Consolidated Financial Statements
Except for the financial statements listed above and the items
specifically incorporated by reference in Items 5, 6, 7, 7.a. and 8 hereof, the
Annual Report to Shareholders is not deemed to be filed as part of this Annual
Report on Form 10-K.
2. Financial Statement Schedules
Schedule II - Valuation and Qualifying Accounts
Balance at Charged to
Beginning of Costs and Charged to Balance at End
Period Expenses Other Accounts Deductions of Period
------------ ---------- -------------- ------------ --------------
Allowance for doubtful
accounts:
2000 $200,000 $ 15,000 $ - $ (61,250)* $153,750
1999 280,000 301,836 - (381,836)* 200,000
1998 188,599 207,511 - (116,110)* 280,000
Inventory reserve:
2000 $ 70,125 $ 64,693 $ - $ - $134,818
1999 45,135 24,990 - - 70,125
1998 91,260 - - (46,125)** 45,135
* Trade accounts receivable written off against the allowance for doubtful
accounts.
** Excess, slow moving or obsolete inventory written off against the inventory
reserve.
13
All other schedules have been omitted because they are not applicable
or not required, or because the required information is included in the
financial statements or the notes thereto.
3. Exhibits
Exhibit
No. Description Method of Filing
- --- ----------- ----------------
3.1 Articles of Incorporation of the Company (as amended) (6)
3.2 Bylaws of the Company (as amended) (13)
4.1 Form of Certificate for Common Stock (1)
4.2 Form of Registration Rights Agreement between the Company and certain
of its shareholders and warrant holders (1)
4.3 Form of Registration Rights Agreement dated as of February 3, 1995
between the Company and certain of its shareholders (2)
4.4 Registration Rights Agreement, dated as of January 30, 1997,
by and between the Company and purchasers of Series I Junior
Participating Preferred Stock (4)
4.5 Registration Rights Agreement, dated as of June 10, 1997,
by and between the Company and the Purchasers (7)
4.6 Form of Certificate for Series I Junior Participating Preferred Stock (4)
4.7 Form of Stock Purchase Warrant, dated as of January 30, 1997 (4)
4.8 Form of Stock Purchase Warrant, dated as of June 10, 1997 (7)
10.1 Real Property Lease Agreements dated July 31, 1996, between
Commers-Klodt, a Minnesota General Partnership, and the Company (11)
10.2 Amendments, dated June 15, 1999, to Real Property Lease Agreements
dated July 31, 1996, between Commers-Klodt, a Minnesota General
Partnership, and the Company (13)
10.3 Master Equipment Lease Agreement dated as of June 15, 1993,
between the Company and Phoenix Growth Capitol Corp., as
amended by Amendment No. 1 dated June 8, 1994 (including
form of warrant issued in connection therewith) (1)
10.4* 1990 Stock Option Plan (as amended and restated), including
form of option agreement (9)
10.5* 1993 Directors' Stock Option Plan, as amended and restated (9)
10.6* 1995 Equalizing Director Stock Option Plan (3)
10.7 1995 Employee Stock Purchase Plan (as revised and restated) (5)
14
10.8 Agreement dated January 1, 1995 between the Company and Vencor, Inc. (2)
10.10 Stock Purchase Agreement, dated as of January 30, 1997,
between the Company and the Purchasers named therein (4)
10.11 Stock Purchase Agreement dated as of June 10, 1997,
between the Company and the Purchasers named therein (7)
10.12 Loan and Security Agreement, dated March 31, 1998, between
DVI Business Credit and the Company (8)
10.13 Common Stock Purchase Agreement, dated June 30, 1998, between
the Company and the Purchasers named therein (9)
10.14 Form of Stock Purchase Warrant, dated August 4, 1998 (9)
10.15 Note Purchase Agreement, dated August 4, 1998, between the
Company and the Purchasers named therein (9)
10.16 Form of Convertible Senior Secured Fixed Rate Note due August 4, 2003 (9)
10.17 Distribution Agreement, dated October 1, 1998, between the Company
and Johnson & Johnson Professional, Inc. (10)
10.18 Put Option and Stock Purchase Agreement, dated October 1, 1998,
between the Company and Johnson & Johnson Development Corporation (10)
10.19 Severance Pay Agreement (in the event of Change of Control) dated
July 31, 1998, between the Company and David T. Giddings (10)
10.20 Form of Severance Pay Agreement (in the event of Change of Control)
dated July 31, 1998, between the Company and its executive officers (10)
10.21 Form of Severance Pay Agreement (in the event of Termination Without
Cause) dated July 31, 1998, between the Company and its executive
officers (10)
10.22 Distribution Agreement, dated June 6, 1999, between the Company
and Hewlett-Packard Company (12)
10.23 Common Stock Purchase Agreement, dated June 6, 1999, between the
Company and Hewlett-Packard Company (12)
10.24 Stock Purchase Warrant, dated effective as of June 28, 1999 (12)
13 Portions of the Company's Annual Report to Shareholders
for the year ended December 31, 2000 incorporated by reference
in this Form 10-K Filed herewith
21 List of Subsidiaries Filed herewith
23 Consent of KPMG LLP Filed herewith
24 Powers of Attorney (included in signature page of Report) Filed herewith
15
99 Cautionary Statements Under the Private Securities Litigation
Reform Act Filed herewith
___________________
* Management compensatory plan filed pursuant to Item 601(b)(10)(iii)(A) of
Regulation S-K.
(1) Incorporated by reference to the Company's Registration Statement on Form
S-1 (Registration Number 33-78518) (the "Registration Statement").
(2) Incorporated by reference to the Company's Registration Statement on Form
S-1 (Registration Number 33-94442).
(3) Incorporated by reference to the Company's 1995 Annual Report on Form 10-
K.
(4) Incorporated by reference to the Company's Current Report on Form 8-K
filed March 25, 1997.
(5) Incorporated by reference to the Company's 1996 Annual Report on Form 10-
K.
(6) Incorporated by reference to the Company's Quarterly Report on Form 10-Q
for the Quarter ended March 31, 1997.
(7) Incorporated by reference to the Company's Current Report on Form 8-K
filed June 26, 1997.
(8) Incorporated by reference to the Company's Quarterly Report on Form 10-Q
for the Quarter ended March 31, 1998.
(9) Incorporated by reference to the Company's Quarterly Report on Form 10-Q
for the Quarter ended June 30, 1998.
(10) Incorporated by reference to the Company's Quarterly Report on Form 10-Q
for the Quarter ended September 30, 1998.
(11) Incorporated by reference to the Company's 1998 Annual Report on Form 10-
K.
(12) Incorporated by reference to the Company's Current Report on Form 8-K
filed July 23, 1999.
(13) Incorporated by reference to the Company's 1999 Annual Report on Form 10-
K.
(b) Reports on Form 8-K
No Current Reports on Form 8-K were filed by the Company during the fourth
quarter of the year ended December 31, 2000.
(c) See Item 14(a)(3) above.
(d) See Item 14(a)(2) above.
16
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized, in the City of
Roseville, State of Minnesota, on March 30, 2001.
DIAMETRICS MEDICAL, INC.
By /s/ David T. Giddings
--------------------------------
David T. Giddings
President, Chief Executive
Officer and Chairman
Pursuant to the requirements of the Securities Exchange Act of 1934, this
report has been signed below by the following persons on behalf of the
registrant and in the capacities and on March 30, 2001.
KNOW ALL MEN BY THESE PRESENTS, that the undersigned do hereby constitute
and appoint David T. Giddings and Laurence L. Betterley, and each of them, each
with full power to act without the other, his true and lawful attorneys-in-fact
and agents, each with full power of substitution and resubstitution, for him and
in his name, place and stead, in any and all capacities, to sign any and all
amendments to the Annual Report on Form 10-K for the year ended December 31,
2000 of Diametrics Medical, Inc., and to file the same, with any and all
exhibits thereto, and all other documents in connection therewith, with the
Securities and Exchange Commission, granting unto said attorneys-in-fact and
agents, full power and authority to do and perform each and every act and thing
requisite and necessary to be done as fully to all intents and purposes as the
undersigned might or could do in person, hereby ratifying and confirming all of
each of said attorneys-in-fact and agents or any of them may lawfully do or
cause to be done by virtue thereof.
Name Title
---- -----
/s/ David T. Giddings President, Chief Executive Officer and
- ------------------------------------
David T. Giddings Chairman (Principal Executive Officer)
/s/ Laurence L. Betterley Senior Vice President and Chief Financial
- ------------------------------------
Laurence L. Betterley Officer (Principal Financial Officer)
/s/ Jill M. Nussbaum Corporate Controller
- ------------------------------------
Jill M. Nussbaum (Principal Accounting Officer)
/s/ Andre de Bruin
- ------------------------------------
Andre de Bruin Director
/s/ Gerald L. Cohn
- ------------------------------------
Gerald L. Cohn Director
/s/ Carl S. Goldfischer
- ------------------------------------
Carl S. Goldfischer, M.D. Director
/s/ Hans-Guenter Hohmann
- ------------------------------------
Hans-Guenter Hohmann Director
/s/ Roy S. Johnson
- ------------------------------------
Roy S. Johnson Director
/s/ Mark B. Knudson
- ------------------------------------
Mark B. Knudson, Ph.D. Director
EXHIBIT INDEX
Exhibit
No. Description
- --- -----------
13 Portions of the Company's Annual Report to Shareholders for the year
ended December 31, 2000 incorporated by reference in this Form 10-K
21 List of Subsidiaries
23 Consent of KPMG LLP
24 Powers of Attorney (included in signature page of Report)
99 Cautionary Statements Under the Private Securities Litigation Reform
Act