UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
Annual Report Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
For the fiscal year ended December 31, 1996. Commission File No. 1-12575
UTAH MEDICAL PRODUCTS, INC.
(Exact name of registrant as specified in its charter)
Utah 87-0342734
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
7043 South 300 West
Midvale, UT 84047
(Address of principal executive offices)
Registrant's telephone number: (801) 566-1200
Securities registered pursuant to Section 12(b) of the Act:
Title of each Class Name of each Exchange on which Registered
Common Stock, $.01 par value New York Stock Exchange
Preferred Stock Purchase Rights New York Stock Exchange
Securities registered pursuant to Section 12(g) of the Act:
None
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 (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 Form 10-K
or any amendment to this Form 10-K.
The aggregate market value of the voting stock held by non-affiliates of the
registrant as of March 14, 1997, based on NYSE closing price: $101,105,648.
The number of shares outstanding of the registrant's common stock as of March
14, 1997: 8,604,736.
DOCUMENTS INCORPORATED BY REFERENCE
List herein the documents incorporated by reference: The Company's definitive
proxy statement for the Annual Meeting of Shareholders is incorporated by
reference into Part III, Items 10, 11, 12, and 13 of this Form 10-K.
<PAGE>
PART I.
ITEM I - BUSINESS.
Utah Medical Products, Inc. ("UM" or "the Company") is in the business of
producing cost-effective devices for the health care industry which are
predominantly proprietary, disposable and for hospital use. Success depends on
1) recognizing needs of clinicians and patients, 2) rapidly designing economic
solutions which gain regulatory approval, 3) reliably producing products that
meet those clinical needs, and then 4) selling through:
a) UM's own direct channels into markets where the Company enjoys an
established reputation and has a critical mass of sales and support
resources, or
b) establishing relationships with other medical companies that have the
proper resources to effectively introduce and support the Company's
products.
UM's success in rapidly producing solutions comes from its proven ability to
integrate a number of engineering and technical disciplines in electronics,
software, mechanical packaging, instrumentation, optics and materials. The
resulting proprietary products represent incremental, but significant
improvements over existing clinical techniques. UM's experience is that, in the
case of labor-saving devices, the improvement in cost-effectiveness of clinical
procedures also leads to an improvement in overall health care. Historically,
UM has marketed a broad range of medical devices used in the critical care areas
and the labor and delivery department in the hospital, as well as products sold
to outpatient clinics and physician's offices.
The skill of applying solutions to recognized needs results from an excellent
core of practicing clinicians who feed ideas to the Company and key employees
who are both clinical applications savvy and development engineering adept.
The Company's current critical care products include devices used for invasive
monitoring of patient blood pressure; the administration of intravenous fluids,
drugs and anesthetics; and oxygen therapy. Obstetrics products include
catheters and electrodes used to invasively monitor intrauterine pressure and
fetal heart rate during labor, along with other monitoring supplies, and a novel
device which safely clamps, cuts, and collects a clean blood sample from the
umbilical cord. Gynecology products include a minimally-invasive electrosurgery
system for removing precancerous tissue from the cervix and lower genital tract,
a system for conservatively treating urinary incontinence, and a tool used in
laparoscopic procedures to manipulate the uterus. In 1996, UM added a unique
ceramic electrosurgical blade electrode which can be used in general surgery
applications for UM's electrosurgery system, for which early use indicates
special interest from plastic surgeons and otolaryngologists.
Critical care products are sold in the U.S. domestic market primarily through
other medical device companies but also by UM's own direct sales
representatives. Ob/Gyn products are sold in the U.S. primarily by UM's own
direct sales representatives, and through a network of specialty distributors.
Internationally, products are sold through other medical device companies and
through independent medical products distributors. UM now has 27 international
distributors for its Ob/Gyn products.
Negative factors that may adversely impact future performance include managed
care reforms or hospital group buying decisions that may limit physicians'
discretion in spending on certain products or procedures, innovative new
products introduced by other companies that displace UM's products, regulatory
approval delays, changes in the Company's relationships with its distribution
partners, and loss of key personnel.
UM was formed as a Utah corporation in 1978. In 1995, Utah Medical Products
Ltd., a wholly-owned subsidiary, was formed to establish an international branch
in Ireland. UM publicly raised equity capital its first and only time in 1982.
After trading on the NASDAQ for 14 years, UM's stock was listed on the NYSE on
December 26, 1996 in conjunction with start of operations in Ireland. The
Company's corporate offices are located at 7043 South 300 West, Midvale, Utah
84047 USA. The corporate telephone number is (801) 566-1200. European
operations are located at Garrycastle Industrial Estate, Athlone, County
Westmeath, Ireland. The telephone number in Ireland is (902) 73932.
PRODUCTS
Obstetrics Market:
Fetal Monitoring
About 60% of births are considered "high risk" due to lack of prenatal care,
among other factors. In many of these births, labor may become complicated and
does not progress normally. The obstetrician must assess progression of labor
to be able to intervene with drug therapy, infuse a solution to augment amniotic
fluid, or ultimately if necessary, perform a Caesarean section, and be prepared
for complications following childbirth. In addition to products already
offered, the Company intends to continue to develop and introduce tools that
enhance fetal monitoring techniques, a core area of focus.
To assist the physician in assessing fetal well-being, changes in fetal heart
rate (FHR) in conjunction with trends in intrauterine pressure exerted on the
fetus are often electronically monitored. UM's intrauterine pressure catheter
product line provides for clinician choices from a traditional fluid-filled
system to INTRAN(R) PLUS, the state-of-the-art transducer-tipped system. In
addition, adjunct FHR electrodes, leg plates, belly bands and chart paper are
offered by UM to complete a package of fetal monitoring supplies. UM's
intrauterine catheters include:
- IUP-075 and other custom catheter kits utilize a saline-filled catheter
that is placed within the uterine cavity, connected to a separate external
reusable or disposable transducer. This product package, utilizing double
lumen catheters, was the traditional mode of intrauterine monitoring prior
to the introduction of INTRAN. An intrauterine pressure waveform is
generated through transmission of a signal to the external pressure
transducer.
- Introduced in 1987, INTRAN I was the first intrauterine pressure catheter
that placed the pressure sensor at the source within the uterine cavity.
This design eliminated the complicated setup of fluid-filled systems and
provided more accurate pressure waveforms. INTRAN I was discontinued in
1995 in favor of the more preferred INTRAN PLUS, which is also covered
under UM's original INTRAN patent.
- INTRAN PLUS was introduced in 1991 and has replaced INTRAN I as the state-
of-the-art sensor-tipped IUP catheter. The INTRAN PLUS catheter combines
the transducer tip concept of INTRAN I with a refined tip design. A
re-zero feature allows the clinician to verify the accuracy of the
reference on the monitor. A dedicated amnio lumen provides immediate
access to the amniotic fluid environment which may be essential in the
diagnosis and intervention of certain fetal conditions. An enhancement to
INTRAN PLUS was introduced in 1996 for physicians who wish to monitor the
color of amniotic fluid before and after an amnioinfusion intervention
without exposing the liquid to the external environment.
Other Obstetrics Tools.
CORDGUARD(R) is a unique product released for marketing in 1995 which unifies
the multiple steps of clamping the neonate's cord close to the umbilicus,
severing the cord without splattering blood, drawing a clean blood sample for
diagnostic or therapeutic purposes, and assisting in the removal of the
placenta. CORDGUARD's sharpless, closed system reduces the risk of exposure,
and consequently reduces the high cost of hospital exposure treatment practices
when both OSHA and CDC guidelines are properly implemented. In addition,
neonatal blood is generally hard to obtain safely and cleanly, while at the same
time it is gaining in perceived diagnostic value to clinicians.
Gynecology Market:
LETZ(R) System: FINESSE(R) Generator; Disposable Loop, Ball, and Needle
Electrodes; FILTRESSE(R) Evacuator; Other Specialty Electrodes and Other
Supplies.
The LETZ System is a complete line of products and supplies used to treat
cervical intraepithelial neoplasia (CIN) and other lower genital tract lesions
related to human papilloma virus (HPV) infections. This procedure of using
electrosurgical excision with hemostasis has widely replaced cold knife scalpel,
laser and cryotherapy procedures because it is economical, safe, effective,
quick and easy to perform, has fewer potential side effects, and requires little
physician training. In contrast to laser and cryotherapy, LETZ provides an
important tissue specimen for a pathological assessment. In addition, the
procedure may be performed by using only local anesthesia in the physician's
office, eliminating the time and expense of hospital or surgical center
admittance. In 1991 the Company introduced a full line of products necessary to
perform the LETZ electrosurgical procedure including the Prendiville disposable
loop, the FINESSE electrosurgical generator and other miscellaneous components.
The FINESSE electrosurgical generator is the only generator on the market that
contains an integral smoke evacuator. The smoke evacuator is required to filter
smoke and vapors which contain potentially hazardous particulate material
produced during electrosurgery. The disposable loop, the electrode used to
excise the tissue specimen, is a pencil-like tube with a thin tungsten wire loop
attached. The loop is available in varying sizes and includes a Safe-T-Gauge(R)
that can be positioned so the physician can more accurately colposcopically
monitor the amount of tissue being excised.
In 1995, UM received FDA clearance to market its electrosurgical system in
general surgery applications, including dermatology applications. In addition,
UM received FDA clearance to market FILTRESSETM, a newly developed stand-alone
surgical smoke filtration system which combines high filtration efficiency, low
cost and convenient use. In 1996, UM received FDA clearance for a specialty
electrode that adds suction of eschared tissue as an integral part to a
coagulation ball. The Company will continue to develop and introduce specialty
tools for specific electrosurgical procedures.
As one important example, in 1996 UM introduced EPITOMETM, a revolutionary
electrosurgical scalpel which delivers precise performance in incision and
excision, where minimization of thermal tissue injury is necessary to ensure
accurate histological analysis, limited morbidity and post-surgical pain, and
cosmetically superior results. The electrode appears to be of particular
interest to otolaryngologists and plastic surgeons.
LIBERTYTM System.
LIBERTY, a device for the conservative treatment and effective control of
urinary incontinence in women was also released for marketing by the FDA in
1995. LIBERTY consists of a battery operated stimulator unit and an
intravaginal electrode probe. This physiotherapy technique, which can be done
in the privacy of home, involves passive strengthening of the periurethral
muscles. Pulsed, low voltage, high frequency current is applied primarily to
the pudendal nerve causing the pelvic area muscles to contract, leading to
better muscle tone. Because electrical stimulation has no known adverse side
effects, Liberty provides women suffering from mild to moderate incontinence an
effective, lower cost and lower risk alternative to more traumatic treatments
such as surgery and drug therapy. Near the end of 1996, UM introduced its
redesigned low-cost version of Liberty, intended for ease of home use by
patients. The prior version, renamed Liberty Ultra, will still be of interest
to physicians who wish to have a full range of waveform options for office use.
In addition to the new Liberty, UM has added several probes, including a probe
for patients requiring rectal use. In addition to its growing
electrostimulation product line, UM intends to add other products that address
various aspects of the very prevalent and diverse incontinence conditions.
Tools for Gynecologic Laparoscopy.
LUMINTM is a proprietary tool developed by UM for reliably and safely
manipulating the uterus in gynecological laparoscopic procedures. The product
was released for marketing by the FDA in 1995. LUMIN combines the strength,
range of motion and versatility of the higher end reusable instruments with the
lower cost and cleanliness of the cheaper disposable instruments presently on
the market, while at the same time reducing the number of tools needed to move
and secure the uterus. The EPITOME scalpel is another UM proprietary tool that
will be useful in laparoscopic procedures.
Neonatal Critical Care Market:
DISPOSA-HOODTM.
The DISPOSA-HOOD is an infant oxygen hood that is used in infant intensive care
to administer oxygen to neonates. The Disposa-Hood, which is placed over the
infant's head, incorporates a round diffusor connection specifically designed to
disperse the incoming gases along the inner surfaces of the hood, rather than
allowing them to blow directly on the infant's head. The design allows more
precise FIO2 (fractional inspired oxygen) control, minimizes convective heat
loss from the head and provides optimum flows for elimination of CO2 (carbon
dioxide) by ventilation. The Disposa-Hood is also designed to prevent
cross-contamination, to allow axial rotation of the infant's head without
contact with the Disposa-Hood and to aid in the maintenance of the neutral
thermal and humidity conditions that are necessary in the care of premature
infants.
Critical Care Market:
Blood Pressure Monitoring Products.
Deltran(R) Disposable Transducer.
A transducer converts one form of energy to another. In pressure monitoring,
it is used to convert physiological (mechanical) pressure into an electrical
signal that can be displayed on electronic monitoring equipment. In medical
applications, transducers had previously been reusable, fragile, subject to
declining accuracy with repeated use and had a cost of about $1,000. The
development of integrated circuit technology and guided laser technology led to
the introduction of the first disposable transducer in the medical market
approximately twelve years ago.
UM has developed and is now distributing its disposable transducer as a
stand-alone product, and as a component in pressure monitoring kits through its
direct representatives and independent distributors, as well as to other medical
companies in the U.S. and internationally.
Although several other medical companies manufacture disposable pressure
transducers ("DPTs"), the Company believes that the Deltran DPT which it has
developed sets the standard in terms of reliability and ease of use. UM has
qualified an automated assembly line which allows UM to effectively compete
with the largest suppliers in terms of low manufacturing costs.
Other Products and Components.
The Company sells products specifically designed for other medical companies
which incorporate UM's proprietary technologies. In addition, UM sells plastic
molded parts to a number of medical companies, including its competitors. UM
believes that this practice has not affected its competitive position, and
extends the benefit that shareholders realize from UM's manufacturing
capabilities and technologies.
Until recently, UM relied on a distribution relationship with Baxter Healthcare
for its DPT products. Now UM intends to investigate other distribution means,
especially in light of the lower cost of DELTRAN IV. In Japan, where UM was
previously restricted from selling through other distribution partners, UM now
has agreed to distribute through Biosensors International.
MARKETING.
UM competes in the marketplace on the basis of its proprietary value-added
technologies and cost effective solutions. Its future success will depend upon
its ability to innovate and introduce new products into specialized market
niches consistent with cost control pressures under a changing health care
environment. Speed is a critical success factor in that future performance
depends on UM's ability to innovate, develop, test and commercialize new
products faster than other medical device companies who possess significantly
more resources than UM. With new products that are unique, the Company must be
prepared for extensive user training and support.
The Company currently competes within three distinct product/market arenas,
each with differing competitive circumstances from the other:
1) Critical Care/Blood Pressure Monitoring.
This is a large, commodity-oriented intensive care/anesthesia monitoring
market dominated by two major U.S. suppliers which bundle disposable
transducers and accessories with venous and arterial catheters. The products
used in monitoring human vital signs have features that are practically
undifferentiated among the major competitors. Consequently, hospital
purchasing decisions tend to be based on price and delivery. Lack of a
dominant distribution partner for this product line, such as Baxter, represents
a negative factor that may adversely impact the future. UM's sales of its
blood pressure monitoring products through other than Baxter distribution
means, although significantly lower in revenues, have historically generated
approximately the same magnitude of gross profit dollars. UM's sales through
distribution partners excluding Baxter, independent U.S. and international
distributors and its limited U.S. direct sales team represented about 5% of the
total annual worldwide end-user market in 1996. The worldwide market at end-
user price for DPT and accessories exceeds $150 million.
2) Obstetrics/Fetal Monitoring.
UM markets its intrauterine pressure catheters ("IUPC") and its fetal heart
rate electrodes to hospital labor and delivery departments. Almost exclusively
limited to the United States where electronic monitoring is accepted practice,
the potential annual market for existing fetal monitoring supplies exceeds $35
million.
The Company's IUPC sales control over 60% of total IUPC unit sales with a
mixture of traditional "fluid-filled" catheters together with sensor-tipped
catheters, where five other suppliers compete. The differentiating features of
UM's INTRAN PLUS IUPC, educational programs, and breadth of line (which includes
both types of IUPCs), have helped UM secure more than a 90% share of the sensor
tipped segment, which represents about 60% of total IUPC units used. Because
UM's IUPC customers are part of U.S. hospitals which are experiencing
consolidation and group purchasing pressures, a negative factor which may
adversely affect future IUPC sales would be the acceptance of a new IUPC
supplier that could bundle a viable but inferior and cheaper IUPC with broad
product lines as part of a group supplies contract. UM believes its patents are
an important barrier to competition, and is currently involved with infringement
litigation against two new market entrants.
The hospital labor and delivery department will continue to offer an excellent
opportunity where UM's established position in fetal monitoring allows
receptiveness for evaluating new obstetrics product concepts. An excellent
example is Cordguard, the device that clamps, cuts, and collects blood from the
umbilical cord. Cordguard is being marketed and sold through UM's existing
sales resources to labor and delivery hospital customers, leveraging current
resources where INTRAN has a well-accepted market position. Blood samples are
routinely collected in about 50% of births in the U.S. now, and are expected to
increase with the greater emphasis being placed on the collection of neonatal
blood for both diagnostic and therapeutic purposes. There are no known
competitors with products that possess Cordguard's proprietary features.
Hospital budgetary constraints represent the most significant obstacle to
Cordguard's acceptance. As with any new product that is unique, the ultimate
acceptance of the product in the marketplace is subject to many customer
preference variables that could result in actual sales performance materially
different from current Company expectations.
3) Gynecological Electrosurgery.
Since 1991, the office and outpatient market for the electrosurgical
cervical loop excision treatment has attracted over ten competitors offering
either electrosurgery generators or disposable loop electrodes, or both. The
current worldwide annual market exceeds $20 million.
UM has continued to utilize its direct sales organization to promote
educational and clinician support programs. Consequently, UM improved its market
share as gynecologists became informed about the advantages of the better
equipment and disposables offered by UM. The Company believes that it has
established superior cutting and hemostasis capabilities in its FINESSE
generators, and an improved safety and "quality tissue specimen" provided by its
patented disposable loop line.
The Company believes that similar surgical procedures will gain wide
acceptance in a number of other specialized areas, including dermatology and
family practice, and plans to develop and introduce products for these areas
based on its electrosurgery expertise. The ultimate adoption of new specialized
products is uncertain because they require a high level of user education,
require purchasers to work against the trend of standardized general-purpose
tool acquisitions, and sales may be limited by the Company's lack of access to
important distribution channels.
In addition to other applications for UM's LETZ electrosurgery system, UM
has exploited its understanding of electrosurgery to develop the EPITOMETM
scalpel. The major uses of EPITOME are most likely to be in non-gynecologic
specialities such as otolaryngology and plastic surgery where precise incisions
and closely controlled excisions in highly vascular regions, with minimal
thermal side effects, are important. In areas such as these where UM does not
have an established market presence, development of new product sales will be
slow unless the Company is successful in establishing OEM distribution
partnerships.
4) Conservative Incontinence Therapy.
Urinary incontinence is an under diagnosed and under reported but prevalent
condition in women, especially physically active women over the age of forty.
In the United States, at least ten million women suffer from time to time from
some form of urinary incontinence: stress, urge or mixed.
Clinical studies have shown that chances are good that the problem can be
improved or cured by strengthening and toning the pelvic floor muscles,
especially in women with mild to moderate stress incontinence. The use of
electrical stimulation to help strengthen muscles is an approach that is
scientifically well understood and is an area of engineering expertise at UM.
Adjunct therapy devices and diagnostic tools will become important to developing
a system of tools for cost-effective urinary incontinence treatment.
The aging of the population and increased interest in more conservative
and non-surgical therapeutic approaches to solving health problems are two
important U.S. trends which will help drive patient adoption of this new
product. UM believes that its reputation with gynecologists as an innovator of
high quality and cost-effective devices like its "LETZTM" product line will aid
in the market acceptance of this therapeutic approach. Market acceptance may be
limited by a number of negative factors including the fact that the
electrostimulation therapy approach is not a "quick fix" and requires patient
discipline to continue a treatment regimen over an extended time span, as well
as the fact that the treatment may require a greater time commitment with less
revenue dollars than alternative surgical approaches for gynecologists
prescribing it.
DISTRIBUTION.
Another important success factor in a changing health care industry is
"access" to customers. In particular, the U.S. hospital supplier environment
has been consolidating as a result of group purchasing decisions and product
bundling by large suppliers with diverse product lines. The number of channels
and length of time required in evaluating new products for use in hospitals has
grown dramatically in recent years. As a potential negative factor to future
performance, as UM introduces new products, it may find itself limited with its
current distribution channels, or unable to establish viable relationships with
other medical companies who have adequate access to users.
Historically, UM has sold its products, especially those relating to critical
care, through independent distributors and other medical companies in both
domestic and international markets. However, since 1991, the Company has
developed a more focused direct sales organization in the United States with
specialized distributors and its own directly employed sales force. The network
of direct representatives and specialty distributors is employed to concentrate
on select market applications for UM products in geographic territories where
they can provide proper customer training and support.
In March 1997, the U.S. direct sales force consists of 25 territory
representatives and sales managers. Especially through the use of
closely-controlled clinical education programs, the direct sales force positions
UM to gain market leadership with its value-added products within certain niche
market applications in obstetrics and gynecological procedures which are
trending toward outpatient clinics and physician offices.
The Company also sells products into commodity markets, or for applications
which do not generate enough business to justify a direct selling effort,
directly to other medical companies. Additionally, the Company sells component
parts to medical companies for use in their product lines. This effort is
simply an optimal utilization of manufacturing resources that are needed for
UM's main businesses and does not affect the Company's marketing programs.
The Company sells its products internationally through distributors or through
OEM (other medical manufacturers) relationships.
RESEARCH AND NEW PRODUCT DEVELOPMENT.
New product development is a key to UM's growth plans. UM's current new
product development projects are in three areas of focus: 1) obstetrics/ fetal
monitoring, 2) female incontinence, and 3) specialized electrosurgical
procedures. In terms of R&D output, UM has filed eleven new patent applications
in the last four years. In the medical device industry, FDA premarketing
approval submissions are one indicator of new product development activities for
a given company. In that regard, in the last three years, sixteen FDA
premarketing approval submissions have been completed.
Because of UM's reputation as a successful innovator, its financial strength
and its established clinician user base, it enjoys a substantial flow of new
product ideas. Senior management comprises a steering committee which
continuously screens ideas and investigates new product opportunities. Internal
development, joint development, product acquisitions, and licensing arrangements
are all included as viable options in the investigation of opportunities. Only
a small percentage of ideas survive steering committee feasibility screening.
For internal development purposes, upon steering committee approval, projects
are assigned to a project manager who assembles an interdisciplinary, cross-
functional development team. The team's objective is to have a clinically
proven, manufacturable, and FDA released product ready for marketing by a
specific date. Approximately twelve projects on the average, depending on the
level of resources required, are underway at UM at any given time. More than
50% of assigned projects do not succeed in attaining a product which meets all
of the Company's criteria. In particular, this includes a product that is
highly reliable, easy to use, cost-effective, safe, useful and differentiated
from the competition.
Once a product is developed, tooled, fully tested and cleared for marketing by
the FDA, there remains a reasonable probability it cannot be successfully
marketed for any number of reasons, not the least of which is being beaten to
the market by a competitor with a better solution or not having access to users
because of limitations in marketing and distribution resources.
During 1996, the Company spent $1,387,088 on new product development, which was
3.6% of sales. Included in these expenses were amounts paid to outside entities
for activities required for the conduct of clinical evaluations. During 1995
and 1994, new product development expenses were $1,789,167 (4.3% of sales) and
$1,528,476 (3.9% of sales), respectively. Expenditures for R&D projects are
expected to continue at similar rates, limited more by the Company's ability to
process new ideas, as well as organize and integrate the speciality skills
necessary to develop innovative products, than by the availability of funds or
new product ideas.
EMPLOYEES.
At December 31, 1996, the Company had 290 employees, 25 of which are located in
Ireland. The Company's continued success will depend to a large extent upon its
ability to retain its skilled employees. No assurances can be given that the
Company will be able to retain or attract such employees in the future, although
management is committed to providing an attractive environment in which creative
and high achieving people want to work.
To the best of the Company's knowledge, none of the Company's officers or
directors is bound by restrictive covenants from prior employers. All
professional employees sign a confidentiality and non-compete agreement as a
condition of employment. None of the Company's employees is represented by
labor unions or other collective bargaining groups. All employees participate
in performance-based bonus programs.
PATENTS AND TECHNOLOGY LICENSES.
The Company owns thirty-two unexpired patents and is the licensee of certain
other technology. In addition, the Company has applied for other patents.
There can be no assurance, however, that patents will be issued with respect to
the pending applications or that the issued patents can be successfully
defended.
The ability of the Company to differentiate itself is enhanced by the
protection afforded by its patents, but the Company does not feel that its
business success is significantly dependent on any one or more of its patents.
In any case, UM believes that patents are of less significance in its industry
than such factors as innovative skills, technological experience, excellent
marketing programs and the management ability of its personnel. The Company
owns certain proprietary information and obtains a confidentiality and non-
compete agreement from its technical and sales employees, key management and
consultants.
As a matter of policy, UM has acquired and will continue to acquire the use of
technology from third parties that can be synergistically combined with UM
proprietary product ideas. During 1996, royalty expenses were $91,038.
Also as a matter of policy, UM licenses its proprietary technology to others in
circumstances where that licensing does not directly compete with UM's own
marketing direction. During 1996, the Company received $703,352 in royalty
income, compared to $652,894 in 1995, and $650,992 in 1994. This income remains
a material portion of UM's earnings and therefore UM's future performance also
depends on the performance of other companies who license its technology.
The Company has historically vigorously and successfully defended its
proprietary intangible assets in an industry where patent infringement lawsuits
are frequent. Patent infringement lawsuits are currently pending against two
companies who UM believes have infringed its Intran patents.
GOVERNMENT REGULATION.
The Company's products are subject to regulation by the U.S. Food & Drug
Administration ("FDA"), as well as other regulatory bodies globally. The FDA
has authority to regulate the marketing, manufacturing, labeling, packaging and
distribution of medical products. In addition, requirements exist under other
federal laws and under state, local and foreign statutes that may apply to the
manufacturing and marketing of the Company's products. The Medical Device
Amendments of 1976 (the "Amendments") significantly extended the jurisdiction of
the FDA to regulate medical devices. Until the adoption of the Amendments,
medical devices were subject only to general labeling and purity requirements.
The Amendments established three classifications of medical devices, Class I,
Class II, and Class III.
All manufacturers of medical devices must register with the FDA and, with their
initial registration, list all medical devices produced by them. This listing
must be updated annually. In addition, prior to commercial distribution of
devices for human use, the manufacturer must file a notice with the FDA, setting
forth certain information about the device, including the classification into
which the manufacturer believes it falls.
Devices which are classified in Class I are subject only to the general
controls concerning adulteration, misbranding, good manufacturing practices,
record keeping and reporting requirements. Devices classified in Class II must,
in addition, comply with performance standards promulgated by the FDA. The
Company believes all of its present products are Class I or Class II products
and that the Company is in full compliance with all applicable performance
standards as well as good manufacturing practices, record keeping and reporting.
In 1994, UM received certification of its quality system under the ISO 9001/EN
46001 standards ("ISO" stands for "International Organization of
Standardization"). EN 46001 is the European Community's effort to harmonize
different national regulatory requirements for the development, sale, and
manufacture of medical products. Because the ISO standards are in continuous
modification, UM remains on a perpetual periodic audit schedule by its
independent notified body in order to stay abreast of international regulatory
standards. In 1995, UM received formal product certification allowing the use
of the CE Mark (demonstrates proof of compliance with the European Community's
product standards) for its blood pressure monitoring kits, electrosurgical
generators and disposable loop electrodes, representing most of its current
product sales overseas. In early 1997, UM received ISO 9001/EN 46001
certification for its Ireland facility.
SOURCES AND AVAILABILITY OF RAW MATERIALS.
Most of the component parts which the Company purchases from various vendors
are readily available from a number of sources. Alternate sourcing of various
components is continually underway. Vendors are qualified by Corporate Quality
Assurance. The Company has a vendor quality monitoring program that routinely
checks all incoming material.
EXPORTS.
Revenues from foreign customers in 1996 were about $9,739,000 (25% of total
sales), as compared to $10,343,000 (25% of total sales) in 1995, and $10,757,000
(27% of total sales) in 1994. Critical care products represented 91% of
international sales in 1996, compared to 96% in 1995 and 97% in 1994.
UM has developed distinct tactics for each of its European markets in the form
of pricing, distribution and new product introduction. UM is keenly aware that
not only are international markets different from the U.S. market, but also that
each country has its own set of driving influences that affects the dynamics of
the nature of care given and medical devices used.
UM sees the international marketplace as one of the cornerstones of its growth
strategy. During 1996, UM completed a new manufacturing facility in Athlone,
Ireland. The facility offers a number of advantages: 1) from a marketing point
of view, faster response to European Union customers, including a better
understanding of customized needs, less costly distribution and duty-free access
to over 350 million patients; 2) from a regulatory point of view, faster new
product introductions; and 3) from a manufacturing point of view, reduced
dependence on one manufacturing site and increased capacity at existing Utah
facilities.
BACKLOG.
As a marketer of primarily disposable products, the nature of UM's business
necessitates being very responsive to customer orders and delivering products
quickly. Thus an objective of UM is to minimize its shippable backlog. Backlog
shippable in less than 60 days including blanket orders from Baxter as of
January 1, 1997, was approximately $0.5 million compared to $2.6 million as of
January 1, 1996. Backlog excluding Baxter orders was approximately the same on
January 1, 1997 and January 1, 1996.
SEASONAL ASPECTS.
The Company's business is generally not affected by seasonal factors.
PRODUCT LIABILITY RISK MANAGEMENT.
No product liability lawsuits have been filed against the Company for any of
its products in the past five years, despite substantially higher product usage
rates over that time. The risk of product liability lawsuits is a negative
factor in UM's business because UM's products are frequently used in inherently
life threatening procedures to help physicians manage higher risk patients.
Although UM's products are proven to be extremely safe over millions of uses,
positive outcomes cannot always occur in the procedures where UM's products are
used. In litigious cultures (such as the U.S.) frequently driven by attorneys
looking for windfalls, patients may look for scapegoats. In any lawsuit against
a company where an individual plaintiff has a permanent physical injury, a
small probability of a large award always exists whether or not a causal
relationship exists. UM is self-insured for product liability risk and reserves
funds against its current performance on an ongoing basis to provide for its
future defense should any lawsuits be filed. No product liability lawsuits are
currently pending.
FORWARD-LOOKING INFORMATION
This report contains certain forward-looking statements and information
relating to the Company that are based on the beliefs of management as well as
assumptions made by, and information currently available to, management. When
used in this document, the words "anticipate," "believe," "project," "estimate,"
"expect," "intend" and similar expressions, as they relate to the Company or its
management, are intended to identify forward looking statements. Such
statements reflect the current view of the Company respecting future events and
are subject to certain risks, uncertainties, and assumptions, including the
risks and uncertainties noted throughout the document. Although the Company has
attempted to identify important factors that could cause the actual results to
differ materially, there may be other factors that cause the forward statement
not to come true as anticipated, believed, projected, expected, or intended.
Should one or more of these risks or uncertainties materialize, or should
underlying assumptions prove incorrect, actual results may differ materially
from those described herein as anticipated, believed, projected, estimated,
expected, or intended.
General risk factors that may impact the Company's revenues include the market
acceptance of competitive products, obsolescence caused by new technologies, the
possible introduction by competitors of new products that claim to have many of
the advantages of UM's products at lower prices, the timing and market
acceptance of UM's own new product introductions, UM's ability to efficiently
manufacture its products, including the reliability of suppliers, success in
gaining access to important global distribution channels, budgetary constraints,
the timing of regulatory approvals for newly introduced products, and third
party reimbursement.
Risk factors, in addition to the risks outlined in the previous paragraph that
may impact the Company's assets and liabilities, as well as cash flows, include
risks inherent to companies manufacturing products used in health care including
claims resulting from the improper use of devices and other product liability
claims, defense of the Company's intellectual property, productive use of assets
in generating revenues, management of working capital including inventory levels
required to meet delivery commitments at a minimum cost, and timely collection
of accounts receivable.
Additional risk factors that may affect non-operating income include the
continuing viability of the Company's technology license agreements, actual cash
and investment balances, asset dispositions, and acquisition activities that may
require external funding.
ITEM 2 - PROPERTIES.
Office and Manufacturing Facilities.
The Company's current operations are located in one 100,000 square foot
facility in Midvale, Utah, a suburb of Salt Lake City, and one 77,000 square
foot facility in Athlone, Ireland. UM owns its property and facilities, with
the exception of a long-term lease on one section of its Midvale parking lot.
The Ireland facility operates as a wholly-owned subsidiary under the name Utah
Medical Products Ltd. In addition, the Company owns a building in Lehi, Utah
which previously housed its molding operations and is currently leased to an
unrelated party.
UM is a vertically-integrated manufacturing company. Capabilities include a
machine shop for mold-making and building assembly tools and fixtures; plastics-
forming including thermoplastic forming, injection molding and extrusion; sensor
production; assembly of mechanical, electrical and electronic components;
testing; and advanced packaging in clean room conditions. Facilities also
include a well-equipped R&D lab, communications and information systems
networked internationally, and administrative offices.
ITEM 3 - LEGAL PROCEEDINGS.
The Company may be a party from time to time in ordinary routine litigation
incidental to its business. The outcomes of lawsuits which are currently
pending are not projected to have a materially adverse effect on UM's financial
condition or results of operations.
ITEM 4. - SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
No matter was submitted to a vote of security holders through the solicitation
of proxies or otherwise during the fourth quarter of the fiscal year covered by
this report.
PART II.
ITEM 5 - MARKET FOR THE REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS.
Market Information
The Registrant's common stock began trading on the New York Stock Exchange
(symbol: UM) on December 26, 1996. It previously traded on the National Market
System of the National Association of Securities Dealers Automated Quotation
System (symbol UTMD). The following table sets forth the high and low sales
price information as reported by NASDAQ and NYSE for the periods indicated:
High Low
1996
First Quarter ............. $21.50 $31.875
Second Quarter ............ 18.875 11.625
Third Quarter ............. 13.125 11.00
Fourth Quarter ............ 14.75 11.25
1995
First Quarter ............. $11.00 8.50
Second Quarter ............ 13.625 9.50
Third Quarter ............. 17.50 11.625
Fourth Quarter ............ 21.375 13.375
Stockholders:
The approximate number of beneficial stockholders of the Registrant's
common stock as of March 10, 1997 was 8,000.
Dividends.
The Company does not currently intend to pay cash dividends on its common
stock in the foreseeable future. It is the present intention of the Company to
use earnings to finance future growth, for selective infusions of technological,
marketing or product manufacturing rights to broaden the Company's product
offerings, and for continued share repurchases when the price of the stock
remains extremely undervalued.
ITEM 6 - SELECTED FINANCIAL DATA.
<TABLE>
<CAPTION>
Years Ended December 31,
1996 1995 1994 1995 1996
----------- ----------- ----------- ----------- -----------
<S> <C> <C> <C> <C> <C>
Net sales $38,672,632 $42,038,082 $39,644,684 $36,999,059 $36,129,459
Net income 8,753,891 8,353,738 7,109,360 7,012,285 6,869,720
Earnings per common share,
assuming full dilution .93 .82 .68 .60 .57
Total Assets 28,915,685 33,330,379 27,365,183 28,344,113 27,969,840
Long-term Debt None None None None None
Cash Dividends
Per Common Share None None None $.06 None
Quarterly Data for 1996
First Quarter Second Quarter Third Quarter Fourth Quarter
------------- -------------- ------------- --------------
Net Sales $ 9,967,590 $10,089,176 $ 9,993,639 $ 8,622,227
Gross Profit 4,595,059 5,005,227 4,989,655 4,533,439
Net Income 2,483,535 2,170,856 2,190,399 1,909,101
Earnings Per Common Share
Assuming Full Dilution .25 .23 .24 .21
Quarterly Data for 1995
First Quarter Second Quarter Third Quarter Fourth Quarter
------------- -------------- ------------- --------------
Net Sales $ 9,754,041 $10,711,974 $10,715,736 $10,856,330
Gross Profit 4,371,363 5,005,019 5,015,850 5,096,811
Net Income 1,820,517 2,090,422 2,160,299 2,282,498
Earnings Per Common Share
Assuming Full Dilution .18 .21 .21 .23
</TABLE>
ITEM 7 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATION.
The following comments should be read in conjunction with accompanying financial
statements.
Productivity of Assets and Working Capital.
a) Assets.
Total UM asset turns (ratio of sales to total assets) declined in 1996 because
sales decreased 8% while average total assets increased 2.6% from the prior
year. Year-ending 1996 total assets declined because the 22% increase in non-
cash assets, due primarily to the investment in Ireland manufacturing
facilities, was more than offset by the use of excess cash generated from
profitable operations to repurchase the Company's shares. Until UM expands
sales of new Ob/Gyn products to offset lost sales of blood pressure monitoring
transducers to Baxter, which prior to 1996 represented about 39% of total sales,
total asset productivity will remain below the targeted turn rate of 1.4.
1996 net (after accumulated depreciation) property, plant and equipment assets
(PP&E) in Utah decreased $300,000, but in Ireland increased $4.8 million. Utah
PP&E asset turns based on ending PP&E asset balances were 5.0, still an
excellent ratio for a vertically-integrated manufacturing company. Consolidated
PP&E asset turns were 2.9 based on year-ending balances, as more than $4.4
million in Ireland facilities was invested without significant contribution by
those assets in generating revenues in 1996.
Inventory turns declined in 1996 due to lower sales with 10% higher average
inventory balances. Higher average inventory balances resulted from UM not
shutting off its suppliers as rapidly as Baxter reduced its purchases of UM
products, maintaining higher balances as a contingency as certain production
operations were transferred to Ireland, and ramping up production of newer
products, especially Deltran IV and Cordguard, in anticipation of better sales
results. The 1996 year-ending accounts receivable (A/R) balance declined almost
$2.7 million, allowing calculated days in receivables to improve to 40, based on
4Q 1996 shipments' volume. The calculation overstates the improvement because
of the decline in Baxter business. Ignoring 4Q Baxter sales, days in
receivables improved to 45. At the end of 1996, aged A/R over 90 days from
invoice date were about 3% of total accounts receivable.
Working capital declined almost $9.3 million in 1996, caused by the cash
investment of $4.8 million in Ireland PP&E and the repurchase of stock that
exceeded net income by $5.8 million. Components of the change included ending
cash & equivalents down about $8.7 million, total receivables down about $1.7
million, inventories up $1.5 million, and other miscellaneous working capital
items down $0.4 million. Current liabilities (C/L) were up 10% because of $0.7
million still due the Ireland contractor. Otherwise C/L were down in proportion
to lower sales activity. Through its excellent profitability, UM can internally
finance its planned non-cash working capital growth that is needed to support
new sales growth. In 1997, operations are expected to continue to generate
after-tax cash at a rate similar to 1996.
b) Liabilities.
UM has no long term debt obligations. Current liabilities are expected to grow
in conjunction with the increase in expenses associated with higher sales. The
total debt ratio (which is made up almost entirely of current liabilities) at
the end of 1996 was about 16%.
Results of Operations.
a) Revenues.
In 1996, revenues were down 8.0% from 1995. On a quarter-to-previous-year's
quarter basis, 1996 revenues were respectively up 2.2%, down 5.8%, down 6.7% and
down 20.6%.
UM divides revenues into three product-line categories: 1) critical care, which
is comprised primarily of components used in invasive blood pressure monitoring,
but also includes components for other types of pressure monitoring, as well as
disposable respiratory products used in hospitals; 2) obstetrics, which is
comprised mainly of devices for monitoring intrauterine pressure during labor
and delivery, although to a lesser extent electrodes for fetal heart rate
monitoring as well as other labor and delivery supplies, and a new product which
unifies and improves clinician safety in, the multiple step procedure of
cutting, clamping and drawing blood samples from the umbilical cord immediately
following childbirth; and 3) gynecology, which is comprised of an
electrosurgery system and electrodes used in a procedure called LETZ(R) as well
in other types of electrosurgeries, tools used in other minimally invasive
surgical procedures including diagnostic laparoscopies, and a device for
conservative treatment of urinary incontinence. In these three areas, UM's
primary revenue contributors generally enjoy a dominant market share and have
important product features protected by patents.
In 1997, UM intends to expand sales of its new products EpitomeTM, LibertyTM,
Cordguard(R), Filtresse(R) and Lumin(R) which were launched in 1995 and 1996, as
well as introduce other products in areas of focus including fetal monitoring,
electrosurgery and incontinence therapy.
Critical care revenues represented 50.0% of total 1996 sales, and declined
15.3% from 1995. In the U.S., critical care blood pressure monitoring is a
mature business dominated by two large suppliers, Baxter and Abbott. For
several years until 1996, Baxter purchased nearly 3 million disposable pressure
transducers ("DPT") and accessories annually from UM, representing about 39% of
UM's sales. In 1996, sales to Baxter declined by $3.9 million, and sales to
Baxter represented only 29% of UM's total sales. Baxter OEM revenues (all of
which are included in UM's critical care category) represented 58% of critical
care revenues compared to 66% of critical care revenues in 1995. Sales of
critical care products in 1996 were $19,336,510 compared to $22,827,753 in 1995,
and $23,559,239 in 1994. Sales to Baxter in 1996 were $11,131,944 compared to
$14,996,246 in 1995 and $15,299,369 in 1994.
Sales in the obstetrics sales category declined 2.6% in 1996 and represented
40.9% of total sales, after growing almost 21% in 1995. New competition and
distributor overstocking in the previous year limited INTRAN(R) sales growth in
1996. Despite a high level of initial physician enthusiasm, UM's new product
Cordguard(R) did not generate expected sales to cost conscious hospitals. Sales
of obstetrics products in 1996 were $15,802,300 compared to $16,228,061 in 1995,
and $13,429,690 in 1994.
Gynecology category revenues grew 18.5% in 1996, and represented 9.1% of total
revenues. Gynecology product sales were $3,533,822 in 1996 compared to
$2,982,268 in 1995, and $2,655,755 in 1994. Several new products contributed
modestly to sales growth, including Liberty(R) and Lumin(R) which were
introduced in 1995, and EpitomeTM, UM's unique electrosurgical scalpel
introduced in mid-1996. UM's success with its new gynecology products depends
heavily on providing physician training and support for specific procedures.
Marketing of new products represent significant challenges for UM's resources,
and will require innovative distribution approaches.
UM divides its sales channels into "direct" and "OEM" channels. "Direct sales"
are sales of UM's products by its own employed sales representatives, by
independent commissioned representatives, or by stocking distributors in a
particular geographic region. "OEM sales" are sales of UM products by other
medical device manufacturers either as a component of a kit, or as a repackaged
stand alone product into markets not served by UM's own direct sales resources.
In 1996, direct sales represented about 63% of total sales compared to about 58%
in 1995 and 52% in 1994. In the U.S., 1996 direct sales represented 73% of
sales compared to 68% in 1995 and 64% in 1994.
Dividing sales into the two channels of direct sales and OEM sales for the
product categories of critical care products and obstetrics combined with
gynecology products, yields the following split: direct sales in 1996
represented 27% and 99%, respectively, compared to 22% and 99% in 1995 and 20%
and 99% in 1994.
1996 foreign sales were $9,738,958 compared to $10,343,192 in 1995 and
$10,756,552 in 1994. Practically all international sales have been of critical
care products, for which sales the Company has relied heavily on the efforts of
other medical device companies including Baxter (OEM sales channel). Critical
care products represented 91% of international sales in 1996 compared to 96% in
1995 and 97% in 1994. Sales through Baxter represented 51% of international
sales in 1996 compared to 58% in 1995 and 56% in 1994. Sales through other
(than Baxter) OEM companies represented 16% of total international sales in 1996
compared to 16% in 1995 and 23% in 1994.
UM believes it has substantial sales potential for its existing products in
international markets, and therefore plans to continue to commit its resources
to international business expansion.
b) Gross profit.
Gross profit margins (profit after subtracting costs of manufacturing products
from revenues) in 1996 were 49.4% compared to 46.4% in 1995 and 44.6% in 1994.
The 1996 improvement in average gross profit margin was achieved because of the
percentage increase in sales of UM's Ob/Gyn products from 45.7% of total sales
in 1995 to 50.0% of sales in 1996, combined with a 56% decrease in sales of
UM's least profitable product, the Baxter Summit DPT. Given expected faster
sales growth in the obstetrics and gynecology product lines which have higher
margins relative to UM's critical care products, the trend in improved gross
margins is expected to continue in 1997, even though Baxter sales will likely
decline by a further $10 million, reducing absorption of fixed manufacturing
overhead costs. UM has improved its gross margins as a percentage of sales
every year for the last eleven years. In recent years, the improvement has come
from improved manufacturing efficiencies, for example, as a result of assembly
process automation, and increased direct sales through UM's own employed
representatives instead of distributors.
c) Operating Profit.
Operating profits, or income from operations, are the profits achieved after
subtracting operating expenses from gross profits. Operating expenses are
subdivided into sales, general and administrative expenses (SG&A) and research
and development expenses (R&D). UM further divides SG&A into the two categories
of sales and marketing expenses (S&M) and general and administrative expenses
(G&A). In 1996, despite the 8% decline in sales, operating profits increased
1.0% to $11,809,395 from $11,693,377 in 1995 and $10,041,372 in 1994. Operating
expenses were 18.9% of sales in 1996 compared to 18.5% of sales in 1995, and
19.2% in 1994. In dollar terms, 1996 operating expenses were lower than in any
of the previous three years. Because of the expected large decrease in Baxter
sales in 1997 compared to 1996, operating expenses in 1997 as a percentage of
total sales are likely to increase substantially.
SG&A expenses in 1996 increased to 15.3% of revenues from 14.3% of 1995
revenues, although in dollar terms SG&A expenses declined to $5.93 million in
1996 from $6.01 million in 1995. Although total SG&A expenses declined, the G&A
expenses portion increased to $2.52 million in 1996 from $2.38 million in 1995
due to incremental administrative costs in starting up a new Ireland subsidiary.
Even though 1997 G&A expenses in dollar terms are budgeted lower than 1996
actuals, they are expected to increase as a percentage of sales.
UM's S&M expenses pertain primarily to the "direct sales" portion of its
business (see previous page). Global direct sales increased about 1% in 1996
while S&M expenses decreased 6%, increasing the productivity of S&M resources.
In 1997, UM's S&M expense ratio is expected to change substantially for two
reasons: 1) the expected decline in Baxter business will reduce total sales;
and 2) two additional U.S. distributors previously representing about 25% of
domestic direct sales were terminated at the beginning of 1997 in favor of
adding directly employed sales representatives. The change in distribution will
increase incremental sales due to elimination of distributor discounts, and
improve gross profits, but will also increase S&M expenses.
R&D expenses in 1996 were 3.6% of sales compared to 4.3% of sales in 1995, and
3.9% in 1994. Although R&D expenses decreased 22% from 1995, UM made six new
product 510(k) premarketing submissions to the FDA, consistent with submission
activity for the previous two years. The Company employs specialist R&D
resources not only to internally develop its own new product ideas, but also,
through joint development agreements, licensing of technology, acquisitions and
other arrangements, to enhance and complete to commercialization projects
initiated by others. UM expects to continue R&D expenses at approximately the
same dollar level in 1997.
d) Non-operating income.
Non-operating income includes primarily royalties from licensing UM's
technology to other companies, interest and capital gains from investing the
Company's cash, and gains/losses from the sale of assets. Non-operating income
increased $675,809 in 1996 from 1995, and was $919,222 higher than in 1994. The
increase was due to an extraordinary payment in the first quarter of 1996
relating to the use of UM's technology, which is subject to a confidentiality
agreement. Otherwise, royalties remained about the same as in the prior year.
Interest and investment income from cash balances in 1996 was $131,042 lower
than in 1995 due to lower average cash balances. Given no change in interest
rates and no extraordinary acquisition or other non-interest bearing investment
opportunities, 1997 investment income on cash balances is expected to be about
the same as 1996. Royalties received vary from period to period depending on
the desire and/or success of other companies in selling products licensed by UM.
Royalties and other income in 1997 are expected to remain about the same as in
1996, after subtracting the extraordinary payment in the first quarter of 1996
related to the use of UM's pressure monitoring technology.
e) Earnings before income taxes.
Earnings before income taxes (EBIT) result from adding UM's non-operating
income to its operating profits. 1996 EBIT, as a percentage of sales, were
35.3% compared to 30.6% and 27.6% in 1995 and 1994, respectively. Gross margin
improvements, lower operating expenses, and higher non-operating income all
contributed to improved EBIT.
f) Net income and earnings per share.
Net income is EBIT minus income taxes. UM's net income expressed as a
percentage of sales ranks in the top tier of all U.S. publicly-traded companies
at 23%, 20% and 18% for 1996, 1995 and 1994, respectively. After income taxes,
1996 net income was $8,753,891, a new record for the Company, compared to
$8,353,738 in 1995 and $7,109,360 in 1994. The effective income tax rate in
1996 was 35.8% compared to 35.0% in 1995 and 35.1% in 1994. Year to year
fluctuations in the tax rate have resulted from 1) the use of a foreign sales
corporation starting in mid-1992, 2) differing balances in tax-exempt
securities investments, 3) differences in distribution of state income taxes,
and 4) other factors such as R&D tax credits. Consolidated net income (UM U.S.
plus Ireland subsidiary) in 1997 will be incrementally helped by the 10% income
tax rate on profits added in Ireland, compared to the approximate 36% tax rate
in the U.S.
Earnings per share (EPS) is net income divided by the number of shares of stock
outstanding (fully-diluted to take effect for stock options awarded which have
exercise prices below the current market value). Fully diluted 1996 EPS were up
13% to $.93 compared to $.82 in 1995. 1995 EPS were up 21% from $.68 in 1994.
1996 ending weighted average number of common shares assuming full dilution (the
number used to calculate fully-diluted EPS) were 9,451,581 compared to
10,172,329 and 10,453,583 shares in 1995 and 1994, respectively. Actual
outstanding common shares as of December 31, 1996 were 8,785,736. Future EPS
can be increased by investing current net income to increase future net profits
through expanded marketable product offerings and profitable business
operations, or also by repurchasing stock from the marketplace, thereby reducing
the number of outstanding shares. Shareholder value is improved primarily by
consistently increasing EPS. Although UM's EPS increased 13% in 1996, the price
of its stock decreased 32%. In contrast, the Dow Jones Industrial Average
increased 26%, the S&P 500 Index increased 20%, the NASDAQ Composite Index
increased 23%, and the MDDI Index of small medical device companies decreased
9%. Small medical device companies were out of favor compared with the rest of
the stock market in 1996. Historically, UM's stock price has followed closely
its institutional ownership percentage, which declined in 1996.
Return on shareholders' equity (ROE) is the portion of net income retained by
UM to internally finance its growth, divided by average accumulated
shareholders' equity during the period. This ROE ratio determines how fast the
Company can afford to grow without any external financing that would dilute
shareholder interests. For example, a 30% ROE will support 30% growth in
revenues. Achieving growth in revenues and EPS without diluting shareholder
interests maximizes shareholders' value. ROE in 1996 was almost 33%, and has
averaged over 30% for the last ten years.
Cash Flows and Capital Resources.
Cash (and equivalent) balances were $4.5 million at the end of 1996, a decrease
of $8.7 million from December 31, 1995. Cash provided by operating activities,
including adjustments for depreciation and other non-cash operating expenses,
along with changes in working capital, totaled $11,192,927, up from $11,108,155
in 1995, and $8,831,152 in 1994.
EBDIT (profits from operations and non-operating income, adjusted for non-cash
depreciation and amortization expenses and asset write-offs, before taxes) are
a measure of UM's ability to generate cash. 1996 EBDIT were $15.4 million, or
as a ratio of sales, 40%. EBDIT have grown at a 10% compounded annual rate for
the last three years. Since 1987, EBDIT have grown at a 31% compounded annual
rate. Cash of $5,618,000 was used in 1996 for capital expenditures (less
receipts from disposal) for property and equipment. $320,000 was used for the
purchase of intangible assets, including new patent filings. Remaining 1996
investing activities were the purchases and sales of investments which increased
cash by a net $6,701,000.
Capital expenditures that occurred during 1996 should help the Company maintain
its competitive position and provide the cost-effectiveness needed to support
growth in new markets. Projects included: i) a $4,425,000 investment for
completion of the new Ireland manufacturing facility, including enhancements to
the Company's computer and communications systems, ii) about $584,000 in molds
and other tooling for new products, and iii) about $611,000 to maintain and
continuously upgrade pre-existing Utah facilities, equipment and tooling.
Planned 1997 capital expenditures in new facilities, equipment and tooling, and
intangible assets will be funded from cash generated from 1997 operations.
1996 financing activities used cash of $13,982,000 compared to $3,080,000 in
1995, and $8,393,000 in 1994. Stock repurchases continued to comprise by far
the largest use of cash from all categories. The Company repurchased its own
common stock during 1996 in the amount of $14,583,000, compared to $4,154,000 in
1995, and $8,532,000 in 1994. In the four years of 1993 through 1996, UM has
invested $34,433,543 in repurchasing 3,422,909 of its common shares. In 1996,
UM received $602,000 from the issuance of 68,599 shares of stock due to
exercises of employee options. In the four years of 1993 through 1996, the
Company has issued 360,030 new shares previously awarded under option plans,
for which it has received $2,415,000.
Management believes that current cash balances plus future income from
operations will provide the liquidity needed to finance internal growth plans.
In addition to the capital expenditures outlined above, UM plans to use cash in
1997 for selective infusions of technological, marketing or product
manufacturing rights to broaden the Company's product offerings, and for
continued share repurchases when the price of the stock remains extremely
undervalued.
Although UM did not enter into any long term debt agreements in 1996, in 1997,
the Company will open an unsecured line of credit with its bank for up to
$10,000,000 to facilitate its ability to move rapidly in the event of an
opportunity to acquire another company with established revenues and market
position complementary to UM's.
Management's Outlook.
Although the decline in blood pressure monitoring transducer sales to Baxter
accelerated much more rapidly than expected in 1996, the full impact of the
Baxter change will be realized in 1997. Sales to Baxter in 1997 are projected
to decline by another $10 million, unless Baxter modifies its current direction
or UM can find replacement OEM customers. The financial impact of the change
will be primarily lack of absorption of UM's fixed manufacturing overhead, thus
limiting the growth in gross profit margins that would otherwise occur with new
product sales. To find other OEM customers, UM will continue to pursue U.S.
and foreign distribution partners, in addition to those enlisted in 1996, who
are interested in adding blood pressure monitoring transducers to their critical
care product lines. UM believes Deltran to be the recognized best transducer
product available at the lowest cost of production.
In 1997, UM needs to do a better job in effectively implementing its value-
added Ob/Gyn marketing strategies. We believe the fundamental driving needs
for our new Ob/Gyn products, Cordguard, Liberty, LUMIN, Epitome and Filtresse
are real, and the resulting potential markets total about $600 million, ten
times the market potential of UM's previously established Ob/Gyn products.
However, value-added products only become successful in the marketplace if
users understand and accept their value. In that regard, we intend to redouble
our marketing efforts in 1997. We also will seek distribution relationships,
acquisition of complementary product lines and other innovative marketing
approaches that may help expand the use of our new products.
Access to hospital customers is increasingly constrained by group purchasing
decisions. Proprietary products considered essential by physicians are the best
competitive vehicle for UM's hospital supplies business when broad product
offerings and distribution leverage are limited. Therefore, with respect to
cornerstone fetal monitoring (FM) products used in hospitals' labor & delivery
departments, UM must actively defend its existing IUPC patents and continue to
develop new products representing a quantum improvement in care. It is
management's hope that the fetal pH monitoring product, under development for
the past four years, may become such a product. Recently, physicians in
hospitals have had limited input to purchasing decisions. Decisions regarding
patient care may be dominated by immediate purchase cost rather than long-term
total costs which are often related to the risk of bad outcomes. However, UM
will continue to maintain a long-term perspective and strengthen its disease
management focus with Ob/Gyn physicians who we believe are ultimately
responsible for their patients' well-being.
UM's growing number of gynecology practice tools are intended to create
opportunities to sell to physicians outside the hospital. In addition to
broadening the urinary incontinence product line, we will work on doctors'
office gynecology products which address abnormal uterine bleeding, infertility
and potential malignancies, in addition to applying the Company's expertise in
electrosurgery to other clinical areas where a specialized approach will
provide excellent benefits.
In terms of UM's undervalued share price, which has historically tracked UM's
institutional ownership percentage, we feel the time is opportune to introduce
the Company to potential foreign investors, especially given the recent listing
on the New York Stock Exchange and new operations in Ireland. Of course, we
expect the continued use of UM's technology by other medical device companies
to continue to further enhance shareholder returns.
Accounting Policy Changes
The Company has, during 1996, adopted the disclosure-only provisions of
Statement of Financial Accounting Standards (SFAS) No. 123, "Accounting for
Stock-Based Compensation". Accordingly, no compensation cost has been
recognized in the financial statements. Note 7 of the Notes to Consolidated
Financial Statements presents net income and earnings per share as if the fair
value provisions of SFAS No. 123 had been applied.
Effective January 1, 1994 the Company adopted the provisions of Statement of
Financial Accounting Standards (SFAS) No. 115, "Accounting for Certain
Investments in Debt and Equity Securities". Under SFAS No. 115, the Company's
investments are classified as available-for-sale which results in an adjustment
to stockholders' equity for unrealized gains and losses.
ITEM 8 - FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
See index to financial statements and financial statement schedule at page
F-1.
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.
The information from the definitive proxy statement of the registrant under the
caption, "PROPOSAL NO. 1. ELECTION OF DIRECTORS: General," "Directors and
Nominees," "Executive Officers," and "Compliance with Exchange Act
Requirements," is incorporated herein by reference, expressly excluding the
material set forth under the subcaptions "Report of the Compensation and Option
Committee" and "Stock Performance Chart."
ITEM 11 - EXECUTIVE COMPENSATION.
The information from the definitive proxy statement of the registrant under the
caption, "PROPOSAL NO. 1. ELECTION OF DIRECTORS: Executive Compensation,"
"Compensation and Option Committee Interlocks and Insider Participation,"
"Employment Agreements, Termination of Employment, and Change in Control," and
"Director's Compensation" is incorporated herein by reference, expressly
excluding the material set forth under the subcaptions "Report of the
Compensation and Option Committee" and "Stock Performance Chart."
ITEM 12 - SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT.
The information from the definitive proxy statement of the registrant under the
caption, "PROPOSAL NO. 1. ELECTION OF DIRECTORS: Security Ownership of
Management and Certain Persons" is incorporated herein by reference.
ITEM 13 - CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS.
None.
PART IV.
ITEM 14 - EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K.
(a) The following documents are filed as part of this report or incorporated
herein by reference.
1.Financial Statements.
(See Index to Financial Statements and Supplemental Schedule at page F-1.)
2.Supplemental Schedule.
(See Index to Financial Statements and Supplemental Schedule at page F-1.)
3.Exhibits.
SEC
Exhibit Reference Title of Document Location
No. No.
1 3 Articles of Restatement of Incorporated by
the Articles of Incorporation Reference(1)
2 3 Bylaws Incorporated by
3 4 Rights Agreement dated as of Reference(1)
October 28, 1994, between Incorporated by
Utah Medical Products, Inc., Reference(1)
and First Security Bank
4 4 Designation of Rights, Incorporated by
Privileges, and Preferences Reference(1)
of Series "A" Preferred Stock
5 10 Employment Agreement dated Incorporated by
December 21, 1992, Reference(2)
with Kevin L. Cornwell*
6 10 Utah Medical Products, Inc., Incorporated by
1986 Incentive Reference(2)
Stock Option Plan*
7 10 Asset Purchase Agreement with Incorporated by
OB Tech, Inc., Reference(3)
dated January 4, 1994
8 10 Utah Medical Products, Inc., Incorporated by
1994 Employee Incentive Reference(1)
Stock Option Plan*
9 10 Utah Medical Products, Inc., Incorporated by
1993 Directors' Stock Reference(1)
Option Plan
10 10 Utah Medical Products, Inc., Incorporated by
Performance Option Plan* Reference(1)
11 10 Amendment to Asset Purchase Incorporated by
Agreement effective Reference(4)
February 8, 1996
12 21 Subsidiaries of Utah Medical Incorporated by
Products, Inc. Reference(4)
13 23 Consent of Deloitte & Touche This Filing
LLP, Company's independent
auditors
14 27 Financial Data Schedule This Filing
* Management contract or compensatory plan or arrangement required to be filed
pursuant to Item 14(c).
(1) Incorporated by reference from the Company's registration statement on
form S-8 filed with the Commission effective February 10, 1995.
(2) Incorporated by reference from the Company's annual report on form 10-
K filed with the Commission for the year ended December 31, 1992.
(3) Incorporated by reference from the Company's annual report on form 10-
K filed with the Commission for the year ended December 31, 1993.
(4) Incorporated by reference from the Company's annual report on form 10-
K filed with the Commission for the year ended December 31, 1995.
(b) Reports on Form 8-K. None
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 this 28th day of March, 1997.
UTAH MEDICAL PRODUCTS, INC.
By: /s/ Kevin L. Cornwell
Chairman and CEO
By: /s/ Kevin L. Cornwell
Secretary and CFO
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 indicated on this 28th day of March, 1997.
By: Stephen W. Bennett
Director
By: /s/ Kevin L. Cornwell
Director
By: /s/ Ernst G. Hoyer
Director
By: /s/ Perry L. Lane
Director
By: /s/ Lori A. Sessions
Director
UTAH MEDICAL PRODUCTS, INC.
AND SUBSIDIARY
Consolidated Financial Statements as of December 31, 1996
and 1995 and for Each of the Three Years in the Period Ended
December 31, 1996 and Independent Auditors' Report
UTAH MEDICAL PRODUCTS, INC.
INDEX TO FINANCIAL STATEMENTS AND FINANCIAL STATEMENT SCHEDULE
PAGE
CONSOLIDATED FINANCIAL STATEMENTS:
Independent Auditors' Report F-2
Consolidated Balance Sheets, December 31, 1996 and 1995 F-3 - F-4
Consolidated Statements of Operations for the Years
Ended December 31, 1996, 1995, and 1994 F-5
Consolidated Statements of Stockholders' Equity for
the Years Ended December 31, 1996, 1995, and 1994 F-6
Consolidated Statements of Cash Flows for the Years
Ended December 31, 1996, 1995, and 1994 F-7 - F-8
Notes to Consolidated Financial Statements F-9 - F-16
FINANCIAL STATEMENT SCHEDULE:
Financial Statement Schedule for the Years Ended
December 31, 1996, 1995, and 1994:
Schedule II - Valuation and Qualifying Accounts F-17
Financial statement schedules other than those listed above are omitted because
of the absence of conditions under which they are required or because the
information is shown in the financial statements.
<PAGE>
INDEPENDENT AUDITORS' REPORT
Utah Medical Products, Inc.:
We have audited the accompanying consolidated balance sheets of Utah Medical
Products, Inc. and subsidiary as of December 31, 1996 and 1995, and the related
consolidated statements of income, stockholders' equity, and cash flows for each
of the three years in the period ended December 31, 1996. Our audits also
included the financial statement schedule listed in the preceding index to
financial statements and financial statement schedule. These financial
statements and financial statement schedule are the responsibility of the
Company's management. Our responsibility is to express an opinion on the
financial statements and financial statement schedule based on our audits.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, such consolidated financial statements present fairly, in all
material respects, the financial position of Utah Medical Products, Inc. and
subsidiary as of December 31, 1996 and 1995, and the results of their operations
and their cash flows for each of the three years in the period ended December
31, 1996 in conformity with generally accepted accounting principles. Also, in
our opinion, such financial statement schedule, when considered in relation to
the basic consolidated financial statements taken as a whole, presents fairly in
all material respects the information set forth therein.
DELOITTE & TOUCHE LLP
Salt Lake City, Utah
January 24, 1997
<PAGE>
UTAH MEDICAL PRODUCTS, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS, DECEMBER 31, 1996 AND 1995
ASSETS 1996 1995
CURRENT ASSETS: ------------ -----------
Cash $ 3,038,956 $ 5,064,913
Investments available-for-sale (cost: 1996,
$1,364,673 and 1995, $8,121,001) (Note 2) 1,458,543 8,173,500
Accounts receivable:
Trade (less allowance for doubtful
accounts: 1996, $82,086 and 1995, $83,021) 3,804,857 6,473,810
Grant claims receivable 961,408
Accrued interest and other 244,577 221,662
Inventories (Note 3) 4,750,442 3,277,982
Prepaid expenses and other current assets 91,273 244,675
Deferred income taxes (Note 6) 595,639 372,899
------------ -----------
Total current assets 14,945,695 23,829,441
------------ -----------
PROPERTY AND EQUIPMENT (Note 4):
Land 1,126,662 1,113,478
Building and improvements 8,288,750 3,458,829
Furniture, equipment, and tooling 10,066,608 8,868,461
Construction-in-progress 900,622 1,456,837
------------ -----------
Total 20,382,642 14,897,605
Less accumulated depreciation and amortization (7,015,045) (6,031,246)
------------ -----------
property and equipment - net 13,367,597 8,866,359
OTHER ASSETS - Intangible assets (less
accumulated amortization: 1996, $810,171 and
1995, $443,561) 602,393 634,579
------------ -----------
TOTAL $ 28,915,685 $33,330,379
============ ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 1,885,743 $ 1,783,840
Accrued expenses:
Payroll and payroll taxes 1,132,309 1,197,692
Reserve for litigation costs (Note 5) 649,840 314,619
Income taxes payable (Note 6) 105,024
Other 271,947 220,750
Deferred revenue (Note 8) 135,600 85,600
------------ -----------
Total current liabilities 4,075,439 3,707,525
DEFERRED INCOME TAXES (Note 6) 369,759 245,289
DEFERRED REVENUE (Note 8) 87,492 173,208
------------ -----------
Total liabilities 4,532,690 4,126,022
------------ -----------
COMMITMENTS AND CONTINGENCIES (Notes 5, 7, 8,
and 9)
STOCKHOLDERS' EQUITY (Note 7):
Preferred stock - $.01 par value; authorized
- 5,000,000 shares; no shares issued or
outstanding
Common stock - $.01 par value; authorized -
50,000,000 shares; issued - 8,785,736 shares
in 1996 and 9,790,937 shares in 1995 87,857 97,909
Unrealized gain on investments available-for-
sale, net of tax (Note 2) 58,494 32,707
Cumulative foreign currency translation
adjustments 217,444
Retained earnings 24,019,200 29,073,741
------------ -----------
Total stockholders' equity 24,382,995 29,204,357
------------ -----------
TOTAL $28,915,685 $33,330,379
============ ===========
See notes to consolidated financial statements.
UTAH MEDICAL PRODUCTS, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF INCOME
FOR THE YEARS ENDED DECEMBER 31, 1996, 1995, AND 1994
1996 1995 1994
----------- ----------- -----------
NET SALES (Notes 8 and 10) $38,672,632 $42,038,082 $39,644,684
COST OF SALES (Note 8) 19,549,252 22,549,039 21,978,638
----------- ----------- -----------
GROSS MARGIN 19,123,380 19,489,043 17,666,046
----------- ----------- -----------
EXPENSES:
Selling, general, and administrative 5,926,897 6,006,499 6,096,198
Research and development 1,387,088 1,789,167 1,528,476
----------- ----------- -----------
Total 7,313,985 7,795,666 7,624,674
----------- ----------- -----------
INCOME FROM OPERATIONS 11,809,395 11,693,377 10,041,372
----------- ----------- -----------
OTHER INCOME (EXPENSE):
Dividend and interest income 453,918 584,960 352,406
Royalty income 703,352 652,894 650,992
Other, net 677,067 (79,326) (88,283)
----------- ----------- -----------
Total 1,834,337 1,158,528 915,115
----------- ----------- -----------
INCOME BEFORE INCOME TAX EXPENSE 13,643,732 12,851,905 10,956,487
INCOME TAX EXPENSE (Note 6) 4,889,841 4,498,167 3,847,127
----------- ----------- -----------
NET INCOME $8,753,891 $8,353,738 $7,109,360
=========== =========== ===========
EARNINGS PER COMMON AND COMMON
EQUIVALENT SHARE (Note 7) $.93 $.83 $.68
=========== =========== ===========
EARNINGS PER COMMON SHARE
ASSUMING FULL DILUTION (Note 7) $.93 $.82 $.68
=========== =========== ===========
See notes to consolidated financial
statements.
UTAH MEDICAL PRODUCTS, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
FOR THE YEARS ENDED DECEMBER 31, 1996, 1995, AND 1994
<TABLE>
<CAPTION> UNREALIZED
GAIN(LOSS)
ON INVEST- CUMULATIVE
COMMON STOCK ADDI- MENTS FOREIGN
(NOTE 7) TIONAL AVAILABLE CURRENCY
PAID-IN FOR TRANSLA-
---------------- CAPITAL SALE, NET TION
SHARES PAR (NOTE 7) OF TAX ADJUST- RETAINED
VALUE (NOTE 2) MENTS EARNINGS
<S> <C> <C> <C> <C> <C> <C>
BALANCE, JANUARY 1,
1994 11,105,236 $111,052 None $24,702,924
Net income 7,109,360
Shares issued upon
exercise of employee
stock options for
cash (Note 7) 19,785 198 74,416
Shares issued upon
exercise of employee
purchase rights
(Note7) 3,338 33 64,242
Change in unrealized
gain (loss) on
investments
available-for-sale
(Note 2) $(101,815)
Tax benefit
attributable to
appreciation of
common stock related
to stock options and
purchase rights
(Note 7) $11,761
Common stock
purchased and
retired (1,134,800) (11,348) (11,761) (8,508,742)
---------- ------- ------ ----------
BALANCE, DECEMBER 31,
1994 9,993,559 99,935 None (101,815) None 23,442,200
Net income 8,353,738
Shares issued upon
exercise of employee
stock options for
cash (Note 7) 124,840 1,248 811,179
Shares issued upon
exercise of employee
purchase rights
(Note7) 39,668 397 260,736
Change in unrealized
gain (loss) on
investments
available-for-sale
(Note 2) 134,522
Tax benefit
attributable to
appreciation of
common stock related
to stock options and
purchase rights
(Note 7) 355,779
Common stock
purchased and
retired (367,130) (3,671) (355,779) (3,794,112)
--------- ------ -------- ----------
BALANCE, DECEMBER 31,
1995 9,790,937 97,909 None 32,707 None 29,073,741
Net income 8,753,891
Shares issued upon
exercise of employee
stock options for
cash (Note 7) 68,599 686 600,967
Change in unrealized
gain (loss) on
investments
available-for-sale
(Note 2) 25,787
Foreign currency
translation
adjustments $217,444
Tax benefit
attributable to
appreciation of
common stock related
to stock options and
purchase rights
(Note 7) 163,164
Common stock
purchased and
retired (1,073,800) (10,738) (163,164) (14,409,399)
---------- ------- -------- -----------
BALANCE, DECEMBER 31,
1996 8,785,736 $87,857 None $58,494 $217,444 $24,019,200
========== ======= ======= ======== ===========
</TABLE>
See notes to consolidated financial statements
<TABLE>
<CAPTION>
UTAH MEDICAL PRODUCTS, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED DECEMBER 31, 1996, 1995, AND 1994
1996 1995 1994
---------- ---------- ----------
<S> <C> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income $8,753,891 $8,353,738 $7,109,360
---------- ---------- ----------
Adjustments to reconcile net income
to net cash provided by operating
activities:
Depreciation and amortization 1,377,051 1,714,906 1,252,666
Provision for (recovery of) losses
on accounts receivable (935) 5,359 30,266
Loss on disposal of assets 412,224 24,563 41,064
Deferred income taxes (113,854) (74,293) (79,369)
Tax benefit attributable to exercise
and disposition of incentive stock
options and stock purchase rights 163,164 355,779 11,761
Changes in operating assets and
liabilities:
Accounts receivable - trade 2,669,888 (89,813) (502,373)
Accrued interest, grant claims, and
other receivables (984,323) (8,632) 8,537
Inventories (1,472,460) 745,957 186,399
Prepaid expenses and other current
assets 106,083 (131,502) 333,933
Accounts payable 101,903 (37,462) 353,873
Accrued expenses 216,011 334,551 170,631
Deferred revenue (35,716) (84,996) (85,596)
---------- ---------- ----------
Total adjustments 2,439,036 2,754,417 1,721,792
---------- ---------- ----------
Net cash provided by operating
activities 11,192,927 11,108,155 8,831,152
---------- ---------- ----------
CASH FLOWS FROM INVESTING ACTIVITIES:
Capital expenditures for:
Property and equipment (5,639,548) (2,074,745) (1,821,030)
Intangible assets (320,018) (62,144) (521,751)
Purchases of investments (3,315,186) (6,888,832) (3,506,743)
Proceeds from sale and maturities of
investments 10,015,766 4,483,010 6,150,586
Proceeds from sale of property and
equipment 21,750 350 9,145
---------- ---------- ----------
Net cash provided by (used in)
investing activities 762,764 (4,542,361) 310,207
---------- ---------- ----------
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common
stock $601,653 $1,073,560 $138,889
Common stock purchased and retired (14,583,301) (4,153,562) (8,531,851)
---------- ---------- ----------
Net cash used in financing
activities (13,981,648) (3,080,002) (8,392,962)
---------- ---------- ----------
NET INCREASE (DECREASE) IN CASH (2,025,957) 3,485,792 748,397
CASH AT BEGINNING OF YEAR 5,064,913 1,579,121 830,724
---------- ---------- ----------
CASH AT END OF YEAR $3,038,956 $5,064,913 $1,579,121
========== ========== ==========
SUPPLEMENTAL DISCLOSURES OF CASH FLOW
INFORMATION - Cash paid during the
year for income taxes $5,111,183 $4,156,894 $3,831,487
</TABLE>
See notes to consolidated financial statements.
UTAH MEDICAL PRODUCTS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 1996, 1995, AND 1994
1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Utah Medical Products, Inc. and its wholly owned subsidiary, Utah Medical
Products Ltd. which operates a manufacturing facility in Ireland, (the
Company) are in the business of producing cost-effective devices for the
health care industry. The Company's broad range of products includes those
used in critical care areas and the labor and delivery department of
hospitals, as well as outpatient clinics and physician's offices. Products
are sold in both domestic U.S. and international markets.
The accounting policies of the Company conform to generally accepted
accounting principles (GAAP). The preparation of financial statements in
conformity with GAAP requires management to make estimates that affect the
reported amounts of assets and liabilities and disclosure of contingent
liabilities and reported amounts of revenues and expenses. Actual amounts
could differ from these estimates.
The following is a summary of the more significant of the Company's
accounting policies:
PRINCIPLES OF CONSOLIDATION - The consolidated financial statements include
those of the Company and its subsidiary. All intercompany accounts and
transactions have been eliminated in consolidation.
RECLASSIFICATIONS - Certain reclassifications have been made to the 1995
consolidated financial statements to conform to classifications adopted in
1996.
INVESTMENTS AVAILABLE-FOR-SALE - Investments consist of mutual funds, bonds,
and equities. The Company complies with the provisions of Statement of
Financial Accounting Standards (SFAS) No. 115, Accounting for Certain
Investments in Debt and Equity Securities. Under SFAS No. 115, the
Company's investments are classified as available-for-sale which results in
an adjustment to stockholders' equity for unrealized gains and losses (see
Note 2). Realized gains and losses are determined on the specific
identification method.
GRANT CLAIMS RECEIVABLE - Grant claims receivable consists of amounts due
from the Industrial Development Agency (Ireland) under capital and
employment grant agreements for the construction and operation of the
Company's Ireland manufacturing facility.
INVENTORIES - Finished products, work-in-process, and raw materials and
supplies inventories are stated at the lower of cost (computed on a
first-in, first-out method) or market (see Note 3).
PROPERTY AND EQUIPMENT - Property and equipment are stated at cost.
Depreciation and amortization are computed using the straight-line method
over estimated useful lives as follows:
Building and improvements 30 - 40 years
Furniture, equipment, and tooling 3 - 10 years
INTANGIBLE ASSETS - Costs associated with the acquisition of patents,
trademarks, goodwill, and license rights are capitalized and amortized using
the straight-line method over periods ranging from 5 to 17 years.
INCOME TAXES - The Company accounts for income taxes under SFAS No. 109,
Accounting for Income Taxes, whereby deferred taxes are computed under the
liability method (see Note 6).
DEFERRED REVENUE - Amounts received in advance from customers for the sale
of product rights and price reductions are recognized as revenue as the
related products are sold considering the future marketability of the
products.
EARNINGS PER SHARE - Earnings per share are based on the following weighted
average number of shares outstanding:
1996 1995 1994
--------- ---------- ----------
Weighted average number of 9,451,581 10,042,430 10,436,094
common and common equivalent
shares
Weighted average number of
common shares assuming full
dilution 9,451,581 10,172,329 10,453,583
The computation of earnings per common and common equivalent share is based
on the weighted average number of shares outstanding during each year plus
the common stock equivalents which would arise from the exercise of stock
options and warrants outstanding using the treasury stock method and the
average market price per share during the year.
The computation of earnings per common share assuming full dilution is based
on the weighted average number of shares outstanding during the year plus
the common stock equivalents which would arise from the exercise of stock
options and warrants outstanding using the treasury stock method and the
market price per share at the end of the year.
STATEMENTS OF CASH FLOWS - For purposes of the consolidated statements of
cash flows, the Company considers cash on deposit and short-term investments
with original maturities of three months or less to be cash and cash
equivalents.
TRANSLATION OF FOREIGN CURRENCIES - Assets and liabilities of the Company's
foreign subsidiary are translated into U.S. dollars at the applicable
exchange rates at year-end. Net exchange gains or losses resulting from the
translation of the Company's assets and liabilities are reflected as a
separate component of stockholders' equity. Income and expense items are
translated at the average rate of exchange during the year and included in
other income or expense.
2. INVESTMENTS
The amortized cost and estimated market values of investment securities as
of December 31, 1996 were as follows:
GROSS GROSS ESTIMATED
AMORTIZED UNREALIZED UNREALIZED MARKET
COST GAINS LOSSES VALUE
----------- --------- --------- ----------
Municipal bonds $ 521,040 $ (411) $ 520,629
Equities and other 843,633 $104,286 (10,005) 937,914
----------- --------- --------- ----------
Total $ 1,364,673 $104,286 $ (10,416) $1,458,543
=========== ========= ========== ==========
The amortized cost and estimated market value of investments at December 31,
1995 were as follows:
GROSS GROSS ESTIMATED
AMORTIZED UNREALIZED UNREALIZED MARKET
COST GAINS LOSSES VALUE
----------- ---------- --------- ----------
Municipal bonds $ 5,646,994 $ 13,620 $ (961) $5,659,653
Taxable bonds 1,499,844 466 1,500,310
Equities and other 974,163 67,634 (28,260) 1,013,537
----------- --------- --------- ----------
Total $ 8,121,001 $ 81,720 $ (29,221) $8,173,500
=========== ========= ========== ==========
Debt securities amortized cost of $521,040 and estimated market value of
$520,629 at December 31, 1996 are due in one year or less. Expected
maturities will differ from contractual maturities because borrowers may
have the right to call or prepay obligations with or without call or
prepayment penalties.
During the years ended December 31, 1996 and 1995, there were $10,015,766
and $4,483,010, respectively, in proceeds from the sale of investment
securities resulting in gross realized losses of $28,476 and $8,328,
respectively, and gross realized gains of $15,341 and $59,187, respectively.
The net unrealized gain on investment securities available-for-sale included
in stockholders' equity for the years ended December 31, 1996 and 1995 is
$58,494 and $32,707, respectively, which are net of the deferred tax
liability of $35,376 and $19,792, respectively (see Note 6).
3. INVENTORIES
Inventories at December 31, 1996 and 1995 consisted of the following:
1996 1995
---------- ----------
Finished products $1,000,438 $ 872,419
Work-in-process 1,010,086 687,746
Raw materials 2,739,918 1,717,817
---------- ----------
Total $4,750,442 $3,277,982
========== ==========
4. PROPERTY AND EQUIPMENT
Included in the Company's consolidated balance sheets are the assets of its
manufacturing facility in Ireland. Property and equipment, by location, as
of December 31, 1996, are as follows:
U.S. IRELAND TOTAL
---------- ---------- ----------
Land $ 678,447 $ 448,215 $1,126,662
Building and
improvements 3,551,139 4,737,611 8,288,750
Furniture, equipment,
and tooling 9,735,395 331,213 10,066,608
Construction-in-progress 662,514 238,108 900,622
---------- ---------- ----------
Total 14,627,495 5,755,147 20,382,642
Accumulated depreciation
and amortization (6,896,623) (118,422) (7,015,045)
---------- ---------- ----------
Property and equipment,
net $7,730,872 $5,636,725 $13,367,597
========== ========== ===========
At December 31, 1995, assets included in the consolidated balance sheet
attributable to the Ireland facility consisted of $435,000 land and $390,000
construction-in-progress.
5. COMMITMENTS AND CONTINGENCIES
OPERATING LEASES - The Company has an operating lease agreement for land
adjoining the Company's U.S. facilities for a term of forty years commencing
on September 1, 1991. On September 1, 1996 and subsequent to each fifth
lease year, the basic rental is adjusted for published changes in a price
index. Rent expense under the operating lease agreement was $33,225,
$32,400, and $32,400 for the years ended December 31, 1996, 1995, and 1994,
respectively.
Future minimum lease payments under the operating lease obligation as of
December 31, 1996 were as follows:
Year ending December 31:
1997 $ 34,874
1998 34,874
1999 34,874
2000 34,874
2001 34,874
Thereafter 1,034,597
----------
Total minimum lease payments $1,208,967
==========
PRODUCT LIABILITY - The Company is self-insured for product liability risk.
LITIGATION - The Company is involved in lawsuits which are an expected
consequence of its operations and in the ordinary course of business. The
Company believes that pending litigation will not have a materially adverse
effect on its financial condition or results of operations.
6. INCOME TAXES
Deferred tax assets and liabilities as of December 31, 1996 and 1995
consisted of the following temporary differences:
1996 1995
------------------ -----------------
LONG- LONG-
ASSETS CURRENT TERM CURRENT TERM
------- ------- -------- ------
Inventory write-downs
not currently
deductible for tax
purposes $199,477 $102,038
Allowance for doubtful
accounts not
deductible for tax
purposes until written
off 30,946 31,382
Accrued liabilities
not deductible for tax
purposes until paid 349,471 226,915
Deferred revenue
previously recognized
for tax purposes 51,121 $32,941 32,356 $65,473
Other 9,732 65,026
------- -------
Total 631,015 42,673 392,691 130,499
======= ======= ======= =======
LIABILITIES
Unrealized gain on
investments available-
for-sale (35,376) (19,792)
Accelerated
depreciation and
amortization for tax
purposes (412,432) (375,788)
--------- ---------
Deferred income taxes
- net $595,639 $(369,759) $372,899 $(245,289)
======== ========= ======== =========
The components of income tax expense for the years ended December 31, 1996,
1995, and 1994 were as follows:
1996 1995 1994
---------- ---------- ----------
Current $5,003,695 $4,572,460 $3,926,496
Deferred (113,854) (74,293) (79,369)
---------- ---------- ----------
Total $4,889,841 $4,498,167 $3,847,127
========== ========== ==========
Income tax expense differed from amounts computed by applying the statutory
Federal rate to pretax income as follows:
1996 1995 1994
---------- ---------- ----------
Computed Federal
income tax expense
at the statutory
rate of 34% $4,638,869 $4,369,648 $3,725,206
Non-taxable
investment income (76,512) (124,604) (94,266)
State income taxes 718,724 642,638 561,967
Foreign sales
corporation (223,376) (228,760) (251,262)
Other (167,864) (160,755) (94,518)
---------- ---------- ----------
Total $4,889,841 $4,498,167 $3,847,127
========== ========== ==========
7. STOCKHOLDERS' EQUITY
OPTIONS - The Company has stock option plans which authorize the grant of
stock options to eligible employees, directors, and other individuals to
purchase up to an aggregate 4,722,500 shares of common stock. All options
granted under the plans may be exercised from between one and ten years
following the date of grant. The plans are intended to advance the interest
of the Company by attracting and ensuring retention of competent directors,
employees, and executive personnel, and to provide incentives to those
individuals to devote their utmost efforts to the advancement of the
Company.
Changes in stock options were as follows:
PRICE RANGE
1996 SHARES PER SHARE
------- ---------------
Granted 451,500 $14.25 -$20.50
Expired or canceled 276,620 7.25 - 20.50
Exercised 68,599 7.25 - 11.33
Total outstanding at December 31 692,600 7.25 - 14.25
Total exercisable at December 31 295,996 7.25 - 11.33
1995
Granted $ 9.50 - $10.63
Expired or canceled 39,517 6.58 - 10.00
Exercised 124,840 6.33 - 10.00
Total outstanding at December 31 586,319 7.25 - 11.33
Total exercisable at December 31 198,500 7.25 - 11.33
1994
Granted 325,000 $ 7.25 - $10.00
Expired or canceled 73,836 6.58 - 10.00
Exercised 19,785 5.25 - 6.58
Total outstanding at December 31 550,676 6.33 - 11.33
Total exercisable at December 31 184,605 6.33 - 11.33
PURCHASE RIGHTS - The Company adopted an Employees' Stock Purchase Program
in December 1990 whereby employees of record on December 21, 1990 were
granted rights to purchase a maximum of 120,000 shares of common stock at
the grant date market value of $6.58. These purchase rights were exercised
or expired prior to December 21, 1995.
Changes in stock purchase rights were as follows:
PRICE RANGE
SHARES PER SHARE
------- ---------------
1995
Granted None
Expired or cancelled 1,054 $6.58
Exercised 39,668 6.58
Outstanding at December 31 None
Exercisable None
1994
Granted None
Expired or cancelled 1,945 $6.58
Exercised 3,338 6.58
Outstanding at December 31 40,722 6.58
Exercisable 40,722 6.58
For the years ended December 31, 1996, 1995, and 1994, the Company reduced
current income taxes payable and increased additional paid-in capital by
$163,164, $355,779, and $11,761, respectively, for the income tax benefit
attributable to appreciation of common stock related to stock options and
purchase rights.
STOCK-BASED COMPENSATION - The Company has adopted the disclosure-only
provisions of Statement of Financial Accounting Standards (SFAS) No. 123,
Accounting for Stock-Based Compensation. Accordingly, no compensation cost
has been recognized in the financial statements. Had compensation cost for
the Company's stock option plans been determined based on the fair value at
the grant date for awards in 1995 and 1996 consistent with the provisions of
SFAS No. 123, the Company's net earnings and earnings per share would have
been reduced to the pro forma amounts indicated below:
1996 1995
---------- ----------
Net earnings - as reported $8,753,891 $8,353,738
Net earnings - pro forma 8,580,509 8,240,947
Earnings per share assuming full dilution $ .93 $ .82
- - as reported
Earnings per share assuming full dilution .91 .81
- - pro forma
The fair value of each option grant is estimated on the date of grant using
the Black-Scholes option-pricing model with the following assumptions:
1996 1995
---------- ----------
Expected dividend yield 0.0% 0.0%
Expected volatility 48.7% 48.7%
Risk free interest rate
(weighted average) 6.57% 7.4%
Expected life of options 3.6 years 3.6 years
The per-share weighted average fair value of options granted during 1996 and
1995 is $4.67 and $4.14, respectively.
8. PRODUCT SALE AND PURCHASE COMMITMENTS
The Company had exclusive and nonexclusive agreements to sell certain
products to Baxter Healthcare Corporation (Baxter) under license agreements
and had sales to Baxter of approximately $11,132,000, $14,996,000, and
$15,299,000 during the years ended December 31, 1996, 1995, and 1994,
respectively.
The Company has license agreements with other unrelated companies to provide
exclusive and non-exclusive rights to purchase, market, distribute, or
manufacture the Company's products. The Company received royalties and
license fees, some of which were received in advance and have been deferred
and amortized over the terms of the respective agreements.
The Company has license agreements for the rights to develop and market
certain products owned by unrelated parties. Under the terms of such
agreements, the Company is required to pay royalties ranging from 1.5% to
5.0% of sales, and in one case certain payments to the developer contingent
upon the product achieving certain annual revenue thresholds.
9. EMPLOYEE BENEFIT PLAN
The Company has a contributory 401(k) savings plan for employees who work 30
hours or more each week, who are at least 21 years of age, and have a
minimum of one year of service with the Company. The Company's contribution
is determined annually by the Board of Directors and was approximately
$78,800, $57,200, and $52,100 for the years ended December 31, 1996, 1995,
and 1994, respectively.
10.EXPORT SALES
Sales to customers in foreign countries were approximately $9,739,000,
$10,343,000, and $10,757,000 for the years ended December 31, 1996, 1995,
and 1994, respectively.
******
SCHEDULE
II
UTAH MEDICAL PRODUCTS, INC.
VALUATION AND QUALIFYING ACCOUNTS
FOR THE YEARS ENDED DECEMBER 31, 1996, 1995, AND 1994
- -----------------------------------------------------
ADDITIONS
BALANCE CHARGED BALANCE
AT TO AT
DESCRIPTION BEGINNING COSTS AND END OF
OF YEAR EXPENSES DEDUCTIONS YEAR
- ----------- --------- --------- ---------- -------
ACCUMULATED AMORTIZATION OF
INTANGIBLE ASSETS:
1996 $443,561 $366,610 $810,171
======== ======== ========
1995 $102,078 $342,333 $850 $443,561
======== ======== ======= ========
1994 $55,208 $46,870 $102,078
======== ======== ========
ALLOWANCE FOR DOUBTFUL ACCOUNTS:
1996 $83,021 $935 $82,086
======== ======= ========
1995 $77,662 $(5,359) $83,021
======== ======= ========
1994 $47,396 $32,665 $2,399 $77,662
======== ======== ======= ========
ALLOWANCE FOR SALES RETURNS:
1996 $24,545 $24,545
======== ========
1995 $24,545 $24,545
======== ========
1994 $12,545 $12,000 $24,545
======== ======== ========
(1) Deductions represent accounts written off
against the allowance.
(2) Amount represents recoveries which increased
the allowance.
INDEPENDENT AUDITORS' CONSENT
We consent to the incorporation by reference in Registration Statement Nos.
33-24781, 33-44100, 33-89394, and 33-89434 of Utah Medical Products, Inc. on
Forms S-8 of our report dated January 24, 1997, appearing in this Annual
Report on Form 10-K of Utah Medical Products, Inc. for the year ended
December 31, 1996.
/s/ DELOITTE & TOUCHE LLP
Salt Lake City, Utah
March 27, 1997
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE BALANCE SHEET
AS OF DECEMBER 31, 1996, AND STATEMENTS OF OPERATIONS FOR THE YEAR ENDED DECEMBER 31,
1996, AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<S> <C>
<PERIOD-TYPE> 12-MOS
<FISCAL-YEAR-END> DEC-31-1996
<PERIOD-START> JAN-01-1995
<PERIOD-END> DEC-31-1996
<CASH> 3,038,956
<SECURITIES> 1,458,543
<RECEIVABLES> 3,886,943
<ALLOWANCES> (82,086)
<INVENTORY> 4,750,442
<CURRENT-ASSETS> 14,945,695
<PP&E> 20,382,642
<DEPRECIATION> (7,015,045)
<TOTAL-ASSETS> 28,915,685
<CURRENT-LIABILITIES> 4,075,439
<BONDS> 0
<COMMON> 87,857
0
0
<OTHER-SE> 24,295,138
<TOTAL-LIABILITY-AND-EQUITY> 28,915,685
<SALES> 38,672,632
<TOTAL-REVENUES> 38,672,632
<CGS> 19,549,252
<TOTAL-COSTS> 7,313,985
<OTHER-EXPENSES> (1,425,837)
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> (408,500)
<INCOME-PRETAX> 13,643,732
<INCOME-TAX> 4,889,841
<INCOME-CONTINUING> 8,753,891
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 8,753,891
<EPS-PRIMARY> 0.93
<EPS-DILUTED> 0.93
</TABLE>
