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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
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[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 (FEE REQUIRED).
FOR THE FISCAL YEAR ENDED: DECEMBER 27, 1996.
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 (NO FEE REQUIRED).
FOR THE TRANSITION PERIOD FROM TO .
COMMISSION FILE NUMBER: 0-26268
MINIMED INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
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DELAWARE 95-4408171
(STATE OR OTHER JURISDICTION OF (I.R.S. EMPLOYER
INCORPORATION OR ORGANIZATION) IDENTIFICATION NO.)
12744 SAN FERNANDO ROAD
SYLMAR, CALIFORNIA 91342
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICE) (ZIP CODE)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (818) 362-5958
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SECURITIES REGISTERED PURSUANT TO SECTION 12(B) OF THE ACT: NONE
SECURITIES REGISTERED PURSUANT TO SECTION 12(G) OF THE ACT:
TITLE OF EACH CLASS
Common Stock, $.01 par value
Preferred Stock Purchase Rights
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 is not contained herein, and will not be contained, to the
best of registrant's knowledge, in definitive proxy or information statements
incorporated by referenced 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 at March 19, 1997 was $151,207,190. The number of shares
outstanding of the registrant's Common Stock as of March 19, 1997 was
11,641,236.
DOCUMENTS INCORPORATED BY REFERENCE:
Portions of the following document are incorporated herein by reference:
Part III -- The Registrant's Proxy Statement for its 1997 Annual Meeting (the
"1997 Proxy").
Exhibit Index List is located at page 47.
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MINIMED INC.
ANNUAL REPORT ON FORM 10-K
FOR THE FISCAL YEAR ENDED DECEMBER 27, 1996
PAGE NO.
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PART I
Item 1. Business.................................................................. 3
Item 2. Properties................................................................ 22
Item 3. Legal Proceedings......................................................... 22
Item 4. Submission of Matters to a Vote of Security Holders....................... 23
PART II
Item 5. Market for Registrant's Common Equity and Related Stockholder Matters..... 25
Item 6. Selected Consolidated Financial Data...................................... 26
Item 7. Management's Discussion and Analysis of Financial Condition
and Results of Operations................................................ 27
Item 8. Financial Statements and Supplementary Data............................... 32
Item 9. Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure...................................... 47
PART III
Item 10. Director and Executive Officers of the Registrant........................ 47
Item 11. Executive Compensation................................................... 47
Item 12. Security Ownership of Certain Beneficial Owners and Management........... 47
Item 13. Certain Relationships and Related Transactions........................... 47
PART IV
Item 14. Exhibits, Financial Statement Schedules and Reports on Form 8-K.......... 47
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PART I
ITEM 1. BUSINESS
INTRODUCTION
MiniMed(R) Inc. ("MiniMed" or the "Company") designs, develops,
manufactures and markets advanced microinfusion systems for delivery of a
variety of drugs, with a primary focus on the intensive management of diabetes.
Substantially all of the Company's revenues have been derived from the sale of
external insulin pumps and related disposables, which are designed to deliver
small quantities of insulin in a controlled, programmable profile. The Company
believes that it is the leading provider of these systems in the world with a
present market share in the U.S. of approximately 75% for new pump sales. The
Diabetes Control and Complications Trial (the "DCCT Study"), a landmark, 10-year
study conducted under the auspices of the National Institutes of Health (the
"NIH"), established that close control of glucose levels can prevent or delay
the onset of the long-term consequences of diabetes. Other clinical studies have
demonstrated that the use of insulin pumps offers many advantages over injection
therapy, such as enabling patients to achieve lower glucose variability,
reducing the serious consequences of diabetes and improving patients' quality of
life. The Company has also developed an implantable insulin pump and is
developing continuous subcutaneous glucose monitoring systems intended to enable
further improvement in glycemic control and avoidance of hypoglycemic (low
glucose level) and hyperglycemic (high glucose level) events. The Company's net
sales of external pumps and related disposables have grown at a compounded
annual rate of 30% from $11.8 million in 1990 to $57.1 million in 1996. The
Company believes its primary market is Type I (insulin-dependent,
juvenile-onset) diabetes patients. The American Diabetes Association (the "ADA")
has estimated that there are 800,000 Type I patients in the U.S. and the Company
believes that less than 5% of such patients use insulin pumps.
The Company's programmable external insulin pumps are thin and lightweight
(about the size of a pager) and are designed to be worn under the patient's
clothing, on a belt, in a pocket or elsewhere in order not to interfere with
normal daily activities. The pumps are designed to utilize the Company's
proprietary disposables, consisting of an infusion set and a medication
reservoir, which provide the Company with a continuing source of revenue
following pump sales. The Company's external infusion pumps deliver insulin
subcutaneously in hundreds of microinfusions throughout the day, more closely
simulating delivery by a normal pancreas as compared to the two to four large
(bolus) doses per day with injection therapy. A prospective, cross-over study
published in April 1996 in Diabetes Care has shown that intensive management of
diabetes by insulin pump therapy using the Company's external pump reduces the
risk of hypoglycemic events four- to six-fold as compared to intensive
management of diabetes by multiple daily injections.
In addition to its external pumps, the Company has developed an implantable
pump which to date has been utilized only for insulin delivery. The Company's
programmable implantable pump is similar in function to its external pump, but
is implanted under the skin of the abdomen, releasing insulin directly into the
peritoneal cavity. Peritoneal delivery even more closely simulates normal
pancreatic function than subcutaneous delivery via an external pump. Two recent
studies presented in France found that intensive insulin therapy with an
implantable pump (a majority of which were made by the Company) has significant
advantages over alternative intensive management therapies for Type I patients,
including providing reduced glycemic variability and a significant reduction in
hypoglycemic events. A separate study published in the Journal of the American
Medical Association ("JAMA") in October 1996 found that in Type II (adult onset)
patients, intensive insulin therapy utilizing the Company's implantable pump, as
compared to those patients using multiple daily injections, also provided
reduced glycemic variability, reduced risk of hypoglycemic events without weight
gain and enhanced quality of life. The Company's implantable pump has been
approved for commercial sale in the European Union (the "EU"), and the special
insulin used in the implantable pump is subject to a separate regulatory
approval process in the EU. The manufacturer of this insulin, Hoechst AG, a
German company ("Hoechst"), has applied for such approval. In the U.S., the
Company and Hoechst will file a single application to the Food and Drug
Administration (the "FDA"). Such application will contain both a New Drug
Approval ("NDA") element for the special insulin and a Premarket Approval
("PMA") element for the pump. The Company has completed preparation of the PMA
portion of the application for the implantable pump and is working with Hoechst
in the preparation of the NDA element of the application for the special
insulin.
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Beyond intensive management of diabetes, the Company is seeking to take
advantage of its drug delivery expertise by exploring applications of its pumps
with drugs other than insulin. The Company believes that its pump technology is
well suited for the delivery of a number of drugs that are difficult to
administer, including drugs that: (i) are made up of fragile, large molecules,
(ii) cannot be ingested orally, (iii) have short half-lives in vivo, (iv)
require sitespecific delivery, (v) have very narrow effective ranges of
concentration, (vi) require a profiled delivery pattern or (vii) would otherwise
require large amounts of drugs that are either expensive or toxic in the high
doses required to achieve therapeutic value. Many genetically engineered and
manufactured proteins and peptides have these characteristics. The Company is in
discussions with a number of biopharmaceutical companies regarding collaboration
on developing the Company's infusion systems for use with drugs other than
insulin and is negotiating an agreement with respect to one new drug for the
treatment of HIV infection.
The Company is also developing a series of continuous glucose monitoring
systems, all of which utilize a sensor that can be inserted into subcutaneous
tissue for continuous monitoring of glucose levels. Each sensor is expected to
last approximately 3 1/2 days, after which the patient would replace it with
another sensor in a different location. The Company has conducted a series of
studies of its glucose sensor, involving 48 patients, and intends to initiate a
multi-center clinical trial later this year. These systems are being developed
to provide minimally invasive, continuous measurements and alarms that warn the
patient when glucose levels become too high or too low. The Company believes
these systems would provide substantial benefits over widely used glucose meters
and strips that provide only intermittent measurements and can cause
considerable discomfort and inconvenience as a result of the need to prick a
finger to draw blood and then use a strip and a meter to determine glucose
levels. Because of the expected advantages of the Company's minimally-invasive
glucose monitoring systems over glucose strips and meters, the Company believes
that its systems, if successfully developed, would enable better disease
management and significantly improve patient compliance.
MARKET OVERVIEW
The Company believes that its most significant near term growth opportunity
is to expand its diabetes business and that other opportunities involving
application of its technology to the delivery of other drugs will become
increasingly important in the future.
Diabetes. Diabetes is a chronic, life-threatening disease, for which there
is no known cure. In patients with diabetes, the body does not produce or
respond adequately to insulin, a hormone produced by the pancreas that is
critical to the metabolism of glucose. In the normal digestive process,
carbohydrates in food are broken down into glucose, which is circulated in the
bloodstream to the cells of the body, where it is converted into energy.
The concentration of glucose in the bloodstream must be controlled within a
relatively narrow range to maintain normal health. Insulin, which is secreted by
the islet cells in the pancreas, is the primary regulatory mechanism by which
the body metabolizes glucose. A normal pancreas produces the correct amount of
insulin required to maintain a person's glucose at proper levels. In patients
with diabetes, however, insulin-producing cells are destroyed or exist in
reduced numbers and/or the body's cells do not effectively metabolize glucose,
thereby eliminating or reducing the body's ability to control glucose levels.
Diabetes is typically classified into two primary types. Type I is the more
severe form of the disease and is characterized by a complete lack of insulin
secretion by the pancreas, a critical and vital mechanism for controlling
glucose levels. As a result, in order to maintain body chemistry balance and
sustain life, Type I patients require lifelong, daily insulin therapy. In Type
II diabetes (the more prevalent form of the disease), the pancreas produces some
insulin but may not produce sufficient quantities to control glucose levels
and/or cell metabolism of glucose may be impaired, resulting in each case in
high glucose concentrations. There is a spectrum of the severity in Type II
diabetes, ranging from those patients whose disease is mild and even
undiagnosed, to those who can usually manage their disease by diet and exercise,
to those who use various oral medications and to the most serious segment that
requires use of insulin.
According to the ADA, diabetes afflicts approximately 16 million people
(approximately 6% of the total population) in the U.S., 800,000 of whom are
estimated by the ADA to suffer from Type I diabetes. Although
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patients with Type I diabetes represent the primary market for the Company's
insulin pumps, there is a small but growing use of insulin pumps for Type II
diabetes. Based on industry sources, the Company estimates that there are
3,500,000 Type II patients using insulin.
People with diabetes experience distress at both high and low levels of
glucose ("hyperglycemia" and "hypoglycemia," respectively), with significant
short- and long-term negative impacts on wellness and mortality. High glucose
levels occurring acutely inhibit the immune system and result in fatigue, slow
healing and lower resistance to infection and, in severe cases, can lead to coma
and death. High glucose levels occurring chronically can result in major,
long-term complications such as retinopathy (eye disease), nephropathy (kidney
disease), neuropathy (nerve disease), male impotence and cardiovascular
complications (heart and blood vessel disease) such as heart attacks and
strokes. Low glucose levels can also lead to complications, including fainting,
weakness and, in severe cases, unconsciousness, permanent loss of cognitive
power and death. Diabetes is a leading cause of blindness in adults 25 - 74
years old (in the U.S. 12,000 - 24,000 new cases annually), renal failure (more
than 13,000 cases in 1990), and amputations (approximately 54,000 cases
annually), according to the ADA. Based upon data from the ADA, diabetes is the
sixth leading direct cause of death by disease in the U.S., accounting for
approximately 160,000 deaths in 1992, not including deaths indirectly caused by
diabetes, such as diabetes-related cardiovascular disease.
The costs to the health care system associated with the treatment of
diabetes and its complications are significant. According to a study prepared by
Lewin-VHI, Inc., a market research firm, the total health care costs in the U.S.
of treating people with all types of diabetes was estimated to be more than $105
billion in 1992 ($1 out of every $7 spent on health care), almost four times the
cost of treating a like number of non-diabetics. This included over $60 billion
for the cost of hospitalization.
Therapy for Diabetes. To avoid the acute effects of diabetes and to reduce
the associated complications, patients with Type I diabetes (and many Type II
patients) must use insulin daily to control glucose levels. A person's glucose
level will vary depending upon food intake, insulin availability, exercise,
stress and illness. Until 1993 there had been an ongoing controversy as to
whether glucose control alone is sufficient and how closely it must be
controlled in order to avoid the complications of the disease. The DCCT Study
settled this controversy, establishing that close glucose control is essential
and sufficient to avoid long-term complications. To achieve good control a
patient needs a continuous infusion of insulin to provide his or her background
metabolic needs, as well as periodic bolus infusions for meals. Pumps can be
programmed to meet these needs because they use only fast-acting insulin
delivered in hundreds of microinfusions throughout the day in a profile that
provides both basal levels and also bolus infusions. Conventional insulin
therapy involves one or two self-administered, daily injections of long-acting
(timed-release) insulin plus diet control and exercise. Intensive injection
therapy requires multiple daily injections (at least three or four per day) of
mixtures of long-acting (timed-release) and fast-acting (regular) insulins, as
well as diet control and exercise. Because of the limited number of injections
and the uneven absorption of timed-release insulins, the Company believes that
neither conventional nor multiple injection therapy controls glucose levels as
well as pump therapy in many patients. The Company's products have been shown in
clinical trials to provide reduced glycemic variability and significantly fewer
severe hypoglycemic events.
To ascertain the actual amount of insulin needed, a patient must have
knowledge of his or her glucose level, which should be measured at least several
times per day. Currently, this is accomplished by pricking a finger with a
needle, drawing a drop of blood, placing it on a disposable strip, inserting the
strip into a small meter about the size of a beeper and waiting 12 seconds to
two minutes for a number to appear on the display. The patient must then assess
his or her carbohydrate intake and, using the measurement of glucose
concentration, determine the appropriate amount of insulin required. If
necessary, the patient then administers that amount of insulin using a syringe,
a pen injector or an infusion pump.
The Company believes that the discomfort, complexity and time associated
with this entire process discourages patient compliance. In addition, the
current glucose monitoring procedure provides measurements at only a few points
in time. With each such determination the patient does not know if his or her
glucose level is rising, falling or remaining stable, which can lead to
erroneous conclusions as to the amount of insulin needed. In spite of these
limitations, the present worldwide market for these glucose meters and strips
and
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related disposables has been estimated to be approximately $2.5 billion. The
glucose monitoring technology being developed by the Company is intended to
compete with these glucose meters and strips, especially for insulin-using
patients, who comprise a majority of the total worldwide glucose meter and strip
market. No assurance can be given, however, that the Company's glucose
monitoring systems will prove to be sufficiently accurate and efficacious, or
that the Company will be able to commercially market these products.
DCCT Study. In 1984, the NIH initiated the $165 million DCCT Study
involving 1,441 Type I diabetics who participated over the entire term of the
study, which was approximately ten years. The study protocol was designed to
determine whether close control of blood glucose levels, approaching "normal"
levels, could prevent the onset and the progression of certain severe, long-term
complications of Type I diabetes. Individuals with diabetes with mild or no
significant complications were randomly divided between the "conventionally" and
"intensively" managed groups. The conventionally managed group took one or two
injections daily of a variety of types of mixed insulins and were required to
measure their blood glucose levels once or twice per day. The
intensively-managed patients were given the choice of multiple daily injections
(three or more injections per day) or use of an insulin pump, and were required
to take at least four glucose measurements daily. The insulin pumps provided by
the NIH were MiniMed's earlier Model 504-S, although a small number of patients
who had already been using other pumps were permitted to continue using their
existing pumps. Among the intensively-managed patients, external pumps were
utilized in 34% of the patient-years overall, and at the end of the study 42% of
the intensively-managed patients were using pumps.
In September 1993, The New England Journal of Medicine published the
results of this landmark study, which concluded that serious consequences of
diabetes were reduced significantly for the intensively treated patient group as
a whole. Progression of the three primary conditions that were evaluated,
retinopathy, nephropathy and neuropathy, was reduced in the intensive group
relative to the conventional group by 76%, 50% and 60%, respectively. However,
in the DCCT Study, the incidence of hypoglycemic events for the composite
intensively managed group was three times higher than for the conventionally
managed group. In spite of that finding, the NIH concluded that Type I patients
should be treated intensively because the risk of hypoglycemic events was
greatly outweighed by the reduction in long-term complications. In fact, the
results of the study were so compelling that the study was terminated a year
earlier than planned.
Recent Clinical Studies. Although the protocol for the DCCT Study was not
intended to compare the benefits of pump therapy with multiple daily injections,
more recent studies have focused on such a comparison and have concluded that
pump therapy has significant advantages.
- External pump vs. multiple daily injections. In April 1996 Diabetes
Care published the results of a prospective, cross-over study by Bruce
Bode, M.D., et al. involving 55 patients who managed their glucose levels
intensively, using multiple daily injections for at least 12 months before
switching to the Company's external pump for a minimum of 12 months. The
study found that the patients achieved reduced glycemic variability and a
four- to six-fold reduction in severe hypoglycemic events with the pump.
Reducing the number of hypoglycemic events is critically important because
such events can result in fainting, weakness and, in severe cases,
unconsciousness, permanent loss of cognitive power and death.
- Implantable pump vs. alternative intensive management therapy in
Type I patients. The EVADIAC study group in France presented two recent
studies which included a comparison of pump therapy using implantable pumps
(a majority of which were manufactured by the Company) to multiple daily
injections and external pumps. The studies, involving more than 240
patients, found that implantable pumps had significant advantages over
alternative intensive management therapies for Type I patients and a
significant reduction in severe hypoglycemic events.
- Implantable pump vs. multiple daily injections in Type II
patients. In October 1996 JAMA published the results of a prospective,
randomized study performed for the U.S. Department of Veterans Affairs
which compared pump therapy using the Company's implantable pump to
multiple daily injections in a total of 105 Type II patients. The study
found that Type II patients with implantable pumps achieved reduced
glycemic variability and reduced risk of hypoglycemic events without weight
gain, as compared to those patients using multiple daily injections, and
enhanced quality of life.
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THE MINIMED SOLUTION
Insulin Pump Technology. The Company's products for diabetes, both those
already available commercially and others under development, reduce the serious
complications of diabetes by enabling patients to more easily, accurately and
intensively manage their glucose levels. The Company's insulin pumps have
substantial advantages over conventional or intensive injection therapy, because
they:
- Result in Fewer Severe Hypoglycemic Events. The recent study
published in Diabetes Care showed that use of the Company's external pumps
reduced severe hypoglycemic events four- to six-fold when compared to
multiple daily injections. Moreover, three other studies have shown that
the Company's implantable pump also significantly reduced such hypoglycemic
events.
- Enable Rapid Insulin Absorption and Availability. The use of
fast-acting insulin allows insulin to be more quickly absorbed into the
blood. Timed-release insulins take considerable time before initiating
metabolism of glucose, which means that a patient using injection therapy
must administer an injection well before the insulin is actually needed.
Changing plans can cause problems. For example, a bolus injection (a single
sizable dose) of timed-release insulin should be taken 45 minutes to an
hour or more before a meal, and, if the carbohydrate intake or the timing
changes, glucose control is impaired. In pump therapy, which uses only
fast-acting insulin, only a few minutes of lead time are required between
the infusion of a bolus and the meal. This time period is even shorter with
the new faster-acting insulin analog which has recently become available.
- Improve Consistency of Insulin Absorption. Fast-acting insulin
delivered by a pump in tiny microinfusions also has low variability in
absorption. By contrast, both conventional therapy and multiple daily
injections require the use of timed-release insulins, which vary in
absorption within the same patient by as much as 25% or more from one day
to the next. Fast-acting insulin has substantially less variability in
absorption, with variability levels as low as 3% in most patients. In
addition, injection therapy requires the patient to administer multiple
injections of insulin in different locations in the body which may have
different absorption characteristics. Pumps, in contrast, deliver the
insulin through an infusion set that is connected for two to three days to
a single site (usually in a patient's abdomen) thereby providing more
consistent absorption.
- Provide Continuous Insulin Supply. The Company's pumps deliver a
continuous infusion of insulin to provide for a patient's background
metabolic needs. Injection therapy, in contrast, requires the repeated
administration of boluses, which form a subcutaneous depot or collection of
insulin and can result in tissue scarring at the injection site. In pump
therapy, fast-acting insulin is delivered in hundreds of microinfusions
throughout the day, thereby reducing the creation of such depots and
further improving the predictability of insulin absorption.
- Enhance Control Through Programmable Delivery. Because the
Company's pumps are programmable, they enable the delivery of insulin to be
more closely matched to a patient's needs as they vary throughout the day.
This capability is especially advantageous during sleep. In particular,
many patients have been shown to suffer from a rise in early morning
glucose levels (known as the "Dawn Phenomenon"). The Company's pumps can be
programmed by the patient to address this condition as well as the many
other predictable fluctuations in glucose levels.
- Improve Patient Quality of Life. In addition to advantages related
to glucose control, the Company believes its pumps provide patients with a
more flexible lifestyle, an important advantage that makes pumps a
particularly attractive alternative to injection therapy. To obtain good
glucose control, patients using multiple daily injections must plan their
schedules in advance, particularly with respect to meals and exercise,
because the timed-release character of long-acting insulin requires the
prediction and timing of insulin needs. Because of the flexibility of
infusion pumps to deliver both a continuous background profile of
fast-acting insulin and larger episodic boluses when needed before meals,
patients are not restricted to the fixed schedule of eating and exercise
that is required for both conventional and intensive injection therapy.
They are less likely to have glucose level fluctuations as the insulin
demands
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of an active life are met. In addition to these lifestyle benefits, many
people using the pump report that they feel much better with pump therapy.
Glucose Sensor Technology. The Company is developing a series of continuous
glucose monitoring systems which utilize a small, thin, pliable sensor to be
inserted into subcutaneous (under the skin) tissue, usually in the abdomen or
upper arm. The sensing element produces an electrical signal proportional to
glucose in the interstitial fluid (fluid in the subcutaneous tissue). The sensor
is connected either by cable to a small recording/display unit for some
products, or to a telemetry device which transmits the signal to a
recording/display unit for other products.
The Company believes that its glucose monitoring systems will, if
successful, offer significant advantages over current methods of monitoring
glucose levels because the Company's systems would:
- Improve Ability of Patients to Normalize Glucose Levels. The
Company's glucose monitoring systems have been shown in limited human
trials to continuously and accurately measure glucose levels as compared to
standard laboratory reference equipment. Such information not only presents
quantitative measurements but will allow patients to determine whether
glucose levels are rising, falling or remaining stable, which will enable
the patient to better manage his or her glucose level.
- Warn Against Dangerously High or Low Blood Glucose Levels. Studies
indicate that patients experience wide swings of glucose levels during a
24-hour period which are not easily detected even by testing with four to
six finger pricks per day. With the Company's continuous glucose monitoring
systems, when a sensor measurement indicates a glucose level above or below
an acceptable range, an alarm will activate, in the form of an audible
signal or a vibration, as well as a flashing marker on the display,
providing a glucose level warning and enabling the patient to take
corrective action. The Company's sensing systems will also operate during
periods of sleep and will sound an alarm to wake the patient if his or her
glucose level gets too high or too low. Significant variations of glucose
levels during sleep can be especially serious, particularly for children.
Such extreme variations of glucose levels can lead to coma, require costly
hospitalization, leave permanent damage and even result in death.
- Improve Patient Compliance. The Company's subcutaneous glucose
sensor is inserted through the skin every 3 1/2 days, thereby avoiding
multiple daily finger pricks. Because it is small, thin and pliable, the
microsensor causes little, if any, patient discomfort. By avoiding the
discomfort, complexity and time associated with repeatedly pricking a
finger to draw blood and waiting for a meter reading of the sample, the
Company's glucose monitoring system is expected to remove many of the
obstacles which are believed to deter patient compliance, particularly in
the case of intensive management of diabetes. A patient using the Company's
glucose monitoring system would need only two sensor insertions (and
possibly two calibrations) per week as compared to at least 28 finger
pricks per week for recommended monitoring with strip meters in an
intensive management regimen.
- Enable Health Care Professionals to Establish Improved Treatment
Protocols. The challenge of establishing a suitable treatment program for
patients beginning intensive management is great. In some medical
practices, patients are hospitalized for several days so that frequent
glucose measurements can be made to enable the generation of a suitable
treatment protocol for a given patient. Even this procedure has limited
efficacy because the patient's behavior in the hospital is different from
his or her normal lifestyle. Continuous sensing and recording outside a
hospital will permit better treatment protocols to be generated at lower
cost and without the need for hospitalization or close surveillance.
No assurance can be given that development of the Company's sensor products
will be successful or that they will be approved for commercial distribution.
OTHER MEDICAL CONDITIONS
The Company has gained considerable expertise from its experience with
infusion of insulin, which it believes can be applied to meet the complex
delivery requirements of many other drugs. Many genetically engineered and
manufactured proteins and peptides have delivery problems comparable to insulin.
Delivery problems for these drugs arise because they contain fragile, large
molecules, cannot be ingested orally, have
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short half lives in vivo, require site specific delivery, have very narrow
effective ranges of concentration, require a profiled delivery pattern or would
otherwise require large amounts of drugs that are either expensive or toxic in
the high doses required to achieve therapeutic value. The Company is exploring
opportunities for applications of delivery systems for other drugs with several
biopharmaceutical companies, including a new drug under development for the
treatment of HIV infection. Many of these drugs have large potential markets.
For example, approximately 1,000,000 people in the United States are infected
with HIV, according to an article published in JAMA in 1996.
The Company is developing a series of pumps to address these delivery
requirements. While the Company believes that such new applications for its
pumps represent a significant opportunity for the future, its efforts in the
area are at a very preliminary stage, and no assurance can be given that the
anticipated collaborative efforts with biopharmaceutical companies will occur,
that the development of such new applications for the Company's pumps will be
successful or that such applications will be approved by the FDA or other
regulatory authorities. In addition, many of the new applications may involve
new drugs which themselves must be approved by the FDA in addition to the
approval required for the use of the Company's infusion systems to deliver the
drugs.
PRODUCTS
CURRENT PRODUCTS
External Insulin Pumps. The Company's external pumps are designed to
provide the patient with an easy, comfortable and flexible means of insulin
infusion in order to maintain glucose levels. They are generally worn by the
patient attached to a belt, placed in a pocket, strapped to a leg or worn on a
cord around the neck. The Company's most technically advanced external pump
product, the Model 507, was introduced in June 1996 and has been well received
by the market. It weighs approximately 3 1/2 ounces and is about the size of a
pager. The pump can accurately deliver throughout the day a controlled,
programmable profile of insulin in several hundred microinfusions of one
microliter each. The insulin delivery profile can thus be adjusted to meet
individual needs. The insulin is delivered from the pump through special
insulin-compatible tubing either to a needle or soft cannula (a tiny tube which
penetrates the skin), usually into the subcutaneous tissue of the abdomen.
The Model 507 represents the fourth generation of the Company's external
pumps, the first of which was introduced in 1983. The Company's pumps have many
safety features, including numerous alarms (36 in the Model 507), maximum
limitations on the rate and amount of basal and bolus deliveries and automatic
shut-off mechanisms to prevent excessive delivery of insulin. The Model 507 is
easier to use and represents an improvement over the earlier Model 506. It
stores a record of the timing and size of the last 12 bolus doses administered
plus daily totals for the past seven days of insulin delivery. It provides the
ability to set a temporary basal rate for particular activities such as
exercise, and it can be programmed to turn itself off if the user does not enter
a command for a specified period of time. It offers an extended bolus delivery
over time ("square wave"), which is especially useful with very fast-acting
insulin analogs and is especially important for high fat content foods. The
Model 507 also incorporates a backlight that makes it easier for a patient to
program his or her pump in low light conditions, and an audible bolus indicator
for the vision impaired.
In September 1996, the Company introduced its Model 505 external insulin
pump. This pump is a reduced feature version of the earlier Model 506. It has
full bolus programming capability but only a single basal rate. It is intended
primarily for those markets where more sophisticated technology has not yet been
introduced.
Insulin pumps and associated disposables are prescribed by physicians to
achieve better control of glucose levels. When a pump is prescribed, a nurse
typically assists in teaching the patient how to use the pump and the related
skills, such as calculating the appropriate amount of insulin for boluses. A
patient typically returns to the physician's office for periodic check-ups and
often contacts the Company's Clinical Services Department for information. While
the Company's external pumps have become increasingly easy to use, physicians do
not prescribe external pumps for certain patients using intensive therapy
because the pumps are a relatively sophisticated means of delivering insulin and
some patients do not have the motivation and ability
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to understand and correctly use them. Also some patients, particularly in their
teenage and early adult years, may object to pumps because they do not like the
idea of having a device attached to their bodies.
Disposables. The Company's external pumps are used with disposable elements
consisting of a tubing set and a special syringe-type reservoir, which stores
the insulin in the pump. The most popular tube sets with soft cannulas have been
marketed under the trade name Sof-set. The Company has introduced more advanced
versions, called the Sof-set QR (for Quick Release) and the Polyfin QR (which
are similar to the earlier Sof-set and Polyfin infusion sets), both of which
incorporate a quick release connector so that patients can more conveniently and
discreetly disconnect the pump for showering, bathing, swimming, exercise or
intimacy. These disposables provide the Company with a continuing source of
revenue from pump customers. Most of these products are labeled to be replaced
every 48 - 72 hours.
The Company estimates that the average increase in direct cost of using
external insulin pumps (including amortizing the suggested retail price of the
pump over the Company's estimate of a five-year useful life plus the cost of the
related disposables) over multiple daily injection therapy is approximately
$1,600 per year. The amount of any offsetting savings, either short- or
long-term, has not been established, although the Company believes that the
longterm savings are substantial.
Implantable Insulin Pump. The Company's implantable insulin pump, the MIP
2001, is similar in function to the external insulin pump but is implanted under
the skin of the abdomen in a relatively minor surgical procedure. Like the
external pump, the implantable pump releases a basal flow of insulin, with
larger bolus doses delivered before meals. The amount of insulin released can be
programmed by the patient with a hand-held communicator to meet individual
needs. The communicator uses radio waves to control the pump, similar to the way
radio waves are used to control cardiac pacemakers. The pump stores
approximately a three-month supply of a special insulin manufactured by Hoechst
and is refilled in the doctor's office from a special syringe by inserting a
needle through the skin and into the pump, which then draws the insulin into its
negative pressure reservoir. The negative pressure reservoir is a significant
safety feature which virtually precludes the possibility of a spill of the
stored medication from a reservoir leak or during refilling.
Clinical trials of the Company's MIP 2001 implantable pump began in the
U.S. and France in 1990. Approximately 260 patients participated in the formal
trial, and approximately 350 additional patients received implantable pumps
outside of the trial. By December 1996, over 1,230 patient years had been
completed under the efficacy portion of the FDA protocol, involving multiple
centers in the U.S. and France. Additionally, many pumps have been implanted in
Europe (mostly in France) outside of the clinical trial, bringing the total
number of units implanted (including replacements) through December 31, 1996 to
approximately 900.
The Company continues its development efforts to improve the implantable
pump and to correct certain complications which arose during the clinical
trials. During the early phase of the trials there was a tendency in
approximately 10 - 15% of patients for blockage or clogging of the
intra-peritoneal catheter or for deposits to collect on a pump valve, resulting
in a decreased rate of infusion. These problems began to escalate in late 1993,
resulting in the Company's decision in June 1994 to discontinue implants in new
patients except for compassionate use. The escalation of the problem was traced
to changes in the insulin when the supplier transferred manufacturing from a
pilot facility to a production facility. The Company was able to develop a
special rinsing procedure to restore full function in most patients and a
"side-port catheter" to simplify this rinsing procedure. As a result, a limited
number of implants were resumed in France, pending final regulatory approval of
the insulin. Regulatory approval in the U.S. and the EU has been delayed by
these problems with the insulin and by the amount of time required to test both
pilot and full production lots of improved insulin.
The Company has verified in laboratory tests that improved formulations of
the insulin supplied by the manufacturer are comparable or superior to the
earlier formulations that had performed acceptably in the Company's pumps. The
Company has developed a new test system and predictive algorithm that enables
quantitative projection of the performance of a given insulin formulation in the
implantable pump. A second test system was installed by the Company at Hoechst.
These systems will be used as a quality control diagnostic tool in the testing
of insulin lots.
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The Company received certification under applicable International Standards
Organization ("ISO") quality standards and received the CE Mark in March 1995
for the MIP 2001 implantable pump, permitting commercial sale throughout the EU.
However, separate approval from the EU is required for the insulin, and Hoechst
has applied for this approval. No assurance can be given that such approval will
be received. Full commercial distribution of the Company's implantable pump in
the EU will be limited until the special insulin required for use in the pump is
approved.
The Company decided not to resume new patient implants in the U.S. until
FDA approval is received because of the high costs of the clinical trial
monitoring. The Company is continuing to pursue approval for commercial sale of
the implantable pump in the U.S. and is working with Hoechst under a procedure
established by the FDA for approval of a combined application for the Company's
pump and the Hoechst insulin. The Company has completed preparation of the PMA
element of the application for the implantable pump and is working with Hoechst
in the preparation of the NDA element of the application for the special
insulin. No assurance can be given that these applications will be approved by
the FDA. If approved, the labeling would limit this insulin for use only in
combination with the Company's implantable pump. If Hoechst were to cease its
efforts to obtain FDA approval or cease to manufacture the insulin, the
Company's implantable pump program would be materially and adversely affected.
PRODUCTS UNDER DEVELOPMENT
The Company believes that its success in the future will depend on
continuing to enhance its existing products and developing new products for the
treatment of diabetes and other medical conditions.
External Pumps. The Company is developing a variation of its Model 507
insulin pump, known as the Model 507C, which will have the capability of storing
in its electronic memory up to three months of information tracking the insulin
use of the patient. A second product being developed, the data collection
system, will permit health care professionals to download to a personal computer
this information from the 507 or 507C, process the information using special
software and print out the results in summary or graphical form. This
information will enable the professional to assess the glucose control of the
patient over the three month period and, where indicated, to adjust the insulin
delivery protocol for the patient. The Company has operating prototypes of these
products and is in the process of testing them and enhancing their design. The
Company expects to seek clearance by the FDA through the 510(k) process for both
these products in the summer of 1997.
The Company is developing a glucose management system in collaboration with
Boehringer Mannheim for use primarily in hospitals. The system is designed to
enable health care professionals to better control the glucose levels of their
patients. This device is expected to be submitted for FDA approval through the
510(k) process.
Disposables and Accessories. The Company has developed a number of
enhancements to its Sof-set infusion set which it intends to submit to the FDA
for clearance under the 510(k) process, with introduction expected later this
year. These enhancements include modifications which are designed to provide
greater patient comfort. To facilitate the insertion of the cannula through the
skin, the Company has developed a device known as the Sof-serter, which allows
the patient to automatically insert the cannula. The Company is also working on
a new generation of disposables known as Sof-set II.
Implantable Pumps. The Company is developing an implantable Constant Flow
Pump, which is not programmable. The pump is designed to be built with a pre-set
flow rate specified by the physician, and is designed to be appropriate for a
number of drugs other than insulin. Approval of this pump by the FDA is expected
to require a PMA, and the Company expects to begin clinical trials under an IDE
in late 1997 or early 1998.
Glucose Monitoring Systems. The Company is developing glucose monitoring
systems which are designed to provide continuous measurement of glucose levels
without the need to draw blood. Although the Company's development efforts are
at an advanced stage, no assurance can be given that the development of these
products will be successful or that they will be approved for commercial
distribution. All of these
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products will utilize a small, thin, pliable microsensor, the "subcutaneous
sensor," which is to be inserted into subcutaneous tissue, generally in the
abdomen or upper arm, to detect glucose levels. Each sensor is expected to last
approximately 3 1/2 days, after which the patient would replace it with another
sensor in a different location. A series of products using this technology is
planned. The first two products involve the Company's glucose sensor connected
by wire to a recording/display device and others are currently planned with
telemetry, permitting wireless communication. One of the first two products will
provide programmable alarms for high and low glucose levels to warn the patient
when glucose levels become too high or too low. This early device will record
but will not display actual glucose readings. The second product will involve
the same hardware but is to be used by health care professionals to evaluate
glycemic control, much like a cardiologist uses a Holter monitor to monitor
cardiac electrical function. This product will record glucose levels and trends
for two to three days after which the data can be downloaded by the professional
into a personal computer for evaluation. In using this system the patient will
be asked to use various prompts to input times of meals, amounts of
carbohydrate, exercise times, and other events affecting glucose metabolism. A
third product will be used by patients to continuously monitor glucose levels.
The Company expects to miniaturize the display unit for this device so that it
can be worn like a wristwatch or carried in a pocket.
The Company's sensors have been evaluated in humans in limited trials
involving 48 patients. The Company will seek approval for a formal multicenter
human trial of the sensors under an Investigational Device Exemption from the
FDA in order to gather clinical data to support submission to the FDA for 510(k)
clearance. The trial is expected to involve four geographically dispersed
medical centers and approximately 40 to 60 patients. The development and
production engineering of these products and various accessories including the
introducer, the transmitter and the receiver/display devices are not yet
complete. If clearance from the FDA is received, the Company also plans to
conduct a field trial before general release. The Company believes that there
will be a substantial market for its glucose monitoring sensors even if the cost
of the sensors exceeds the cost of the glucose strips that they would replace.
However, to maximize penetration of the glucose meter and strip market, the
Company believes that it may be necessary for the price of the Company's sensors
over their useful life to be reasonably comparable to the cost of presently
available strips. No assurance can be given that this objective will be
achieved, particularly if glucose meter companies try to compete with the
Company by drastically reducing prices. Also, because of the size of its
potential market, many other companies are attempting to develop non-invasive
glucose measuring systems.
FUTURE PRODUCTS
A long-term goal of the Company is to develop a system in which a version
of its implantable pump would be coupled with a long-term glucose sensor in a
"closed-loop" system in what would essentially constitute an artificial
pancreas. The goal is to create a device that would automatically maintain
glucose levels within a normal range via feedback from the sensor to the pump to
continuously adjust the rate of insulin infusion without constant intervention
and programming by the patient or physician.
In order for such a system to be feasible, the Company would need to
develop or acquire the technology for a long-term sensor, as well as develop
appropriate technology for the sensor to control the implantable pump so that
they function as a closed-loop system. To that end, the Company is considering
acquiring an option, exercisable prior to the end of 1998 (which option may be
extended under certain circumstances to the end of 1999), to the marketing
rights to long-term sensor technology under development by Medical Research
Group LLC ("MRG"), an entity in which the Company's Chairman and CEO owns a
significant interest. The Company is also considering acquiring from MRG certain
technology under development relating to extending the useful life of the
Company's implantable pump to eight to ten years.
A complete closed-loop system, as described above, would require an IDE and
a PMA, the timing of which are as yet undetermined. No assurance can be given
that further development of the combined system of implantable pump and
long-term sensor will be successful or that it will prove to be safe and
effective and be approved for commercial distribution.
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RESEARCH AND DEVELOPMENT
The Company's research and development activities are performed primarily
by its research and development organization, which consisted of 66 persons as
of February 28, 1997. The Company obtains its product ideas from its staff and
Medical Advisory Board, as well as patients and health care professionals, whose
opinions on products are actively solicited through surveys, field visits,
medical symposia, focus groups and personal relationships. See "-- Medical
Advisory Board." All research and development costs are expensed as incurred,
and for 1994, 1995, and 1996, research and development expenses were $5,372,000,
$7,095,000 and, $7,900,000.
MARKETING AND SALES
Orders for the Company's external insulin pumps in the U.S. are typically
placed by the patient upon the advice and recommendation of his or her
physician, who provides a prescription. The Company's primary marketing efforts
are focused on endocrinologists, diabetologists and other health care
professionals who treat diabetes, and on third-party payors. In 1995 more than
90% of the Company's revenues from the sale of its external pumps was reimbursed
by thirdparty payors (subject to applicable deductible amounts). The Company has
begun to broaden its marketing efforts to include those primary care physicians
who treat relatively large numbers of diabetics in managed care organizations.
The Company sponsors educational symposia in intensive diabetes management for
physicians, other health care professionals and third-party payors, teaching the
benefits of, and providing training in, pump therapy. The Company has trained
over 5,000 health care professionals in the use of its insulin pumps for
intensive management of patients and intends during 1997 to conduct 80 one-day
and 12 two-day symposia in the U.S. and eight one-day symposia in Europe.
Boehringer Mannheim and Eli Lilly & Co. have begun to co-sponsor and contribute
to the funding of these educational programs.
The Company also seeks to develop patient interest in and demand for
diabetes products by providing patients with access to its existing substantial
service and support network, including: (i) the services of an experienced
Clinical Services Department available by telephone, toll-free, 24-hours per
day, seven days per week, to answer patient questions and provide guidance,
advice and trouble-shooting regarding daily pump use; (ii) free short-term,
replacement pumps sent within 48 hours or less to promote continuous therapy;
(iii) an insurance assistance department consisting of 20 people at February 28,
1997 to answer questions, simplify and expedite claims processing and assist
patients in obtaining third-party reimbursement; (iv) participation in a patient
advocacy program in collaboration with the American Association of Clinical
Endocrinologists; (v) an extensive Internet web site (www.minimed.com); (vi)
advertisements in targeted media; and (vii) free videotapes and other
educational material. Under their co-promotion agreement, the Company and
Boehringer Mannheim each send targeted advertising to patients describing the
other's products, including in the case of materials sent by Boehringer
Mannheim, descriptions of the Company's patient service and support network. The
Company has recently expanded its insurance support activities to better address
the growing managed care segment of health care payors in the U.S. The Company
has arrangements with over 50 third-party payors providing for reimbursement for
the Company's external pumps, including contracts with U.S. Healthcare, Inc. and
various Blue Cross/Blue Shield affiliates.
The Company markets its diabetes products and serves customers through a
combination of a direct sales organization and distributors. In addition to
senior sales and marketing management and an extensive in-house support staff,
as of February 28, 1997, the direct sales organization in the U.S. consisted of
four regional directors, 52 field staff personnel and four field insurance
coordinators. These representatives are extensively trained and specialize in
diabetes therapy and the use of the Company's products. The Company compensates
its sales representatives in the U.S. with a base salary, a sales commission and
an annual bonus based on meeting performance objectives. In the U.S., the
Company also contracts with nurse educators (many of whom are registered nurses)
who assist in educating potential patients about use of the Company's external
pumps.
The Company believes that its strategy of maintaining its own direct sales
force dedicated to diabetes is an important factor in market development and an
important competitive advantage. Nevertheless, the
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Company also utilizes independent distributors in the U.S. to augment its direct
sales force and increase the number of physicians served. Internationally,
independent distributors are used to provide sales coverage in geographic areas
not served by the Company's direct sales force. Also, some third-party payors in
the U.S. require that certain classes of purchases be made through specified
distributors, and certain distributors in the U.S. and internationally maintain
substantial infrastructure to support physician and patient needs. In 1996 42%
of revenues were attributable to sales by the Company's direct sales force.
Internationally, the Company has its own sales organizations for France,
Germany, the Netherlands, Belgium and Luxembourg, consisting of 19 people at
February 28, 1997, including administrative staff. The Company has a
distribution manager in the United Kingdom and utilizes independent distributors
in other countries. The Company believes that the international market provides
a significant opportunity for growth and is seeking to expand its international
sales. International sales increased from 7.4% of total revenues in 1992 to
14.2% in 1996. Also, the Company expects that some of its new products and new
applications will be introduced in foreign countries prior to their introduction
in the U.S. because the regulatory approval process in other countries has
generally been less time consuming and less expensive than in the U.S.
MANUFACTURING
The Company purchases from outside vendors most of the components, certain
subassemblies and various services used in the manufacture of its products. The
purchased items are generally produced to the Company's specifications and in
many instances to the Company's designs. The Company then assembles the
components into finished products. Certain disposable products have been
purchased from OEM suppliers.
The Company's Quality Assurance Department provides guidance to vendors and
performs inspections and product tests at various steps in the manufacturing
cycle to ensure compliance with the Company's stringent specifications. The
manufacturing facilities are subject to periodic inspection by regulatory
authorities. See "-- Government Regulation." In 1995 the Company was approved
under ISO 9002 relating to quality standards, and in 1996 it was approved under
ISO 9001 relating to design control standards. Such approvals enable the Company
to quickly introduce certain products into the EU based on annual certification
of the Company's quality system.
In 1996 the Company instituted Demand Flow Technology manufacturing
procedures. This version of "Just in Time" manufacturing is intended to
significantly reduce total manufacturing cycle times, thereby reducing
inventories. Also, the manufacturing line can then be more responsive to
customers orders, quality is improved and manufacturing costs and paperwork are
reduced.
The Company relies on single sources for certain critical components,
including hybrid circuits, integrated circuits, pumping elements, special
batteries, special insulin formulations, and various disposable products and
components as well as a sole source subcontract arrangement for sterilization
services. Arrangements for additional or replacement suppliers for certain of
these components could not be accomplished quickly. The loss of any of these
vendors as a supplier could have a material adverse effect on the Company's
business, financial condition and results of operations.
COMPETITION
At present the Company considers its primary competition in the diabetes
market to be injection therapy. The Company competes against injection therapy
primarily by educating doctors, nurses, patients and managed care organizations
and other third-party payors about the need for intensive management of glucose
levels and the advantages of pump therapy over multiple daily injections.
In the sale of its external pumps, the Company competes with Disetronic
Medical Systems AG, a Swiss company ("Disetronic"), which introduced a
competitive external pump product in the U.S. approximately six years ago. The
Company estimates that Disetronic currently has approximately 25% of the U.S.
market for external pumps for new patients. Internationally, in addition to
Disetronic, the Company competes in the insulin pump market against several
smaller suppliers which generally offer less sophisticated products. The Company
competes with other pump makers primarily on the basis of product design,
quality and utility,
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physician and patient education and support services and price. There can be no
assurance that past, current and potential makers of competitive pumps, some of
which may have substantially greater financial, technical, marketing and other
resources than the Company, will not become more significant factors in the
future.
In the sale of its disposable products, the Company competes with Maersk
Medical A/S, a Danish company ("Maersk"), which has introduced a disposable
system that is compatible with the Company's pumps and is intended to compete
with the Company's Sof-set QR. Other companies may be considering the
manufacture and sale of disposables intended for use with the Company's pumps.
If any such products are successful, they will divert sales of the Company's
disposables, which could have an adverse effect on the Company business,
financial condition and results of operations.
A number of companies, including Strato-Infusaid, Inc. (a subsidiary of
Pfizer Inc.), Medtronic, Inc., Therex Corp. (a subsidiary of Arrow
International, Inc.) and Siemens-Elema (a subsidiary of Siemens AG), have, or
have attempted to, develop and market implantable microinfusion pumps. Infusaid,
Therex and Tricumed Medizintechnik GmbH, a small German company (whose marketing
and manufacturing rights for the Anschutz Pump were recently acquired by
Medtronic Inc.), manufacture non-programmable pumps, which are adequate for
delivery of certain drugs other than insulin and which are less expensive than
programmable insulin pumps. Siemens discontinued its efforts to develop an
implantable insulin pump in 1994. More recently, Strato-Infusaid has
discontinued its insulin program, leaving MiniMed as the only company known to
it to be actively pursuing the application. Infusaid, Medtronic and Therex have
each obtained FDA approval for use of their implantable pumps with certain drugs
other than insulin. Certain of these potentially competitive companies have
substantially greater financial, technical, manufacturing, marketing and other
resources than the Company.
Numerous companies, some of which have substantially greater financial,
technical, manufacturing, marketing and other resources than the Company, are
attempting to develop non-invasive glucose measurement systems. Many of these
noninvasive efforts are being directed to near-infrared spectroscopic
measurements through tissue, such as by analysis of light reflectance from an
arm or transmission through a finger inserted into a well, through an ear lobe
or through other tissue. The technical obstacles to such technologies are
substantial and to date no such instrument has been approved for commercial
distribution by the FDA. However, if such efforts are successful and provided
universal calibration is possible (so far all reports indicate that even with
extensive, individual calibration, results are not adequate), then applications
that can be adequately served by intermittent measurements, such as measurements
in doctors' offices, might be served with such instruments. There are also
several efforts directed to reducing the discomfort associated with the finger
pricks required with current glucose meter systems by reducing the depth of
penetration of the needle, using a laser and/or using other methods to breach
the outer derma layers so as to extract interstitial fluid rather than blood.
There are also other approaches being pursued for glucose level determination.
Several are attempting to draw out interstitial fluid by electrical or chemical
means and then measuring the glucose. There are also at least three other
efforts being directed toward subcutaneous measurement with electrochemical
sensors. It is possible that some patients might prefer such systems to the
Company's continuous glucose monitors for routine monitoring. The successful
development and acceptance of non-invasive or minimally invasive glucose
measurement systems or systems without pain could therefore have a material
adverse effect on the Company's glucose sensor program.
A number of companies and medical researchers are pursuing new delivery
devices, delivery technologies, procedures, drugs and bioengineered therapeutics
for the treatment and prevention of diabetes, such as, for example, pancreas
transplantation and insulin-producing islet and beta cell preparations and
devices. If successful, these technologies and/or medical procedures could have
a material adverse effect on the Company's business, financial condition and
results of operations and could possibly render the Company's products obsolete.
PATENTS, PROPRIETARY RIGHTS AND TRADEMARKS
The Company files patent applications to protect technology, inventions and
improvements that it considers important to the development of its business. The
Company currently holds numerous issued U.S.
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patents and foreign patents and has pending many U.S. and foreign patent
applications that cover various aspects of its technology. In addition, the
Company holds fully paid, non-exclusive, worldwide licenses to several patents
relating to infusion pumps and a license to numerous other patents relating to
implantable pumps.
Litigation may be necessary to enforce patents issued to the Company, to
protect trade secrets or know-how owned by the Company or to determine the
enforceability, scope and validity of the proprietary rights of others. Although
the Company knows of no infringement of patents held by others, it is always
possible that a third-party may assert infringement. The Company believes that
it owns or has the right to use all technology incorporated into its products,
but an adverse determination in any litigation or interference proceeding to
which the Company may become a party could subject the Company to significant
liabilities to third parties or require the Company to seek licenses from third
parties.
Although patent and intellectual property disputes in the medical device
area have often been settled through licensing or similar arrangements,
associated costs may be substantial and could include ongoing royalties.
Furthermore, there can be no assurance that necessary licenses would be
available to the Company on satisfactory terms or at all. Accordingly, an
adverse determination in a judicial or administrative proceeding or failure to
obtain necessary licenses could prevent the Company from manufacturing and
selling certain of its products or its planned products, which would have a
material adverse effect on the Company's business, diversification
opportunities, financial condition and results of operations.
The Company owns the trademarks MiniMed, Sof-set, QR, Sof-set QR, Polyfin,
and certain other trademarks. The Company also relies on certain trade secrets
and proprietary know-how that it seeks to protect, in part, through
confidentiality agreements with its employees and consultants. There can be no
assurances that any unprotected information will not also be developed by
others.
GOVERNMENT REGULATION
Clinical testing, manufacture and sale of the Company's products are
subject to regulation by numerous governmental authorities, principally the FDA
and corresponding state and foreign agencies. In the U.S., the Company is
required to register as a medical device manufacturer with the FDA and state
agencies such as the Food and Drug Branch of the California Department of Health
Services ("DHS"). The Company is subject to inspection on a routine basis by
both the FDA and the DHS for compliance with the FDA's GMP regulations. These
regulations impose certain procedural and documentation requirements upon the
Company with respect to manufacturing and quality assurance activities. Hoechst,
the manufacturer of the special insulin to be used in the Company's implantable
pump, is also subject to regulation and inspection by the FDA, as well as
European regulatory agencies.
Under the Federal Food, Drug and Cosmetic Act (the "Act"), as amended,
medical devices are classified into one of three classes (i.e., Class I, II, or
III) on the basis of the controls necessary to reasonably ensure their safety
and effectiveness. Safety and effectiveness can reasonably be assured for Class
I devices through general controls (e.g., labeling, premarket notification and
adherence to GMPs) and for Class II devices through the use of general and
special controls (e.g., performance standards, postmarket surveillance, patient
registries, and FDA guidelines). Generally, Class III devices are those which
must receive PMA by the FDA to ensure their safety and effectiveness (e.g.,
life-sustaining, life-supporting and implantable devices, or new devices which
have been found not to be substantially equivalent to legally marketed Class I
or Class II devices).
Before a new device can be introduced to the market, the manufacturer
generally must obtain FDA clearance through either a 510(k) premarket
notification or a PMA. A 510(k) clearance will be granted if the submitted data
establishes that the proposed device is "substantially equivalent" to a legally
marketed Class I or Class II medical device, or to a pre-amendment Class III
medical device for which the FDA has not called for PMAs. Generally an
application for 510(k) clearance only requires submission of a file, including
design, manufacturing, test and marketing information, including labeling.
However, in some cases the FDA requires clinical trials under an IDE (as defined
below), even for products to be cleared under the 510(k) process, although in
such instances these trials are generally relatively small and of short
duration. It generally takes
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from four to 12 months from submission to obtain 510(k) premarket clearance, but
may take longer, and there can be no assurance that the Company will obtain
510(k) premarket clearance within this time frame, if at all, for any of the
devices for which it may file a 510(k) notice. The FDA may determine that the
proposed device is not substantially equivalent, or that additional data are
needed before a substantial equivalence determination can be made. A "not
substantially equivalent" determination, or a request for additional data, could
delay the market introduction of new products that fall into this category and
could have a material adverse effect on the Company's business, financial
condition and results of operations.
A PMA must be filed if the proposed device is not substantially equivalent
to a legally marketed device or if it is a pre-amendment Class III device for
which the FDA has called for PMAs. In addition, a "new drug" may not be marketed
without an approved NDA establishing the safety and effectiveness of the drug
for its intended uses. The NDA process is typically costly, lengthy and
uncertain.
In order to obtain a PMA, a device that poses a significant risk to
patients must undergo clinical evaluation under an Investigational Device
Exemption ("IDE") that is granted by the FDA to permit testing of the device in
a limited number of humans in clinical trials conducted at a restricted group of
clinical sites. Similarly, a new drug, such as the insulin used for the
implantable pump, must be evaluated in an Investigational New Drug ("IND")
trial. In addition to obtaining from the FDA an IDE approval or IND
authorization to conduct a clinical trial, the sponsor of the investigational
research must also obtain approval for the clinical research from an
institutional review board or committee established for this purpose by each
medical center where the trials will be conducted. Clinical trials leading to a
PMA or an NDA are intensive and costly activities that usually extend over two
or more years. As the clinical trial progresses under an IDE or IND, the FDA may
at certain milestones allow expansion of the scope of the trial to allow
additional patients or additional clinical sites or both.
In late 1991, the FDA adopted new procedures for the review of products
that involve both devices and drugs, which permit clinical investigation and
approval to be coordinated by a lead center of the FDA. The Company's
implantable pump and the associated insulin comprise a combined device/drug
system that will be regulated under these procedures. Following the adoption of
these procedures, the Company, which had already submitted a PMA application for
the Company's MIP 2001 implantable insulin pump, withdrew its initial
application for a PMA and the Company and Hoechst intend to submit a single
application to obtain FDA approval of the combination product. This is the first
time that Hoechst has sought FDA approval to market insulin in the U.S. Although
the Company and Hoechst will file a single application, it will contain both an
NDA element for the insulin and a PMA element for the pump. The FDA's Center for
Drug Evaluation and Research will be the lead center and will review the NDA
portion of the application, while the Center for Devices and Radiological Health
will be responsible for reviewing the PMA portion. The Company anticipates that,
if the FDA grants approval, such approval would include issuance of an approved
NDA for the insulin and an approved PMA for the pump. There can be no assurance,
however, that the application will ever be approved. Under the Act, even after
approval, each batch of insulin produced by Hoechst for the combination product
would require FDA's certification that the batch meets requisite strength,
quality and purity standards.
Clinical trial results are presented to the FDA in a PMA or NDA
application. In addition to the results of clinical investigations, the
applicant must submit other information relevant to the safety and efficacy of
the device and/or the drug, including the results of non-clinical tests, a full
description of the device and/or drug and their components, a full description
of the methods, facilities and controls used for manufacturing, and proposed
labeling. Such submissions are extremely detailed and complex, often involving
tens of thousands of pages. The FDA staff then reviews the submitted application
and determines whether or not to accept the application for filing. There is no
assurance that either the safety or efficacy data in these submissions will be
deemed sufficiently complete and adequate by the FDA, and if they are not, a
final determination by the FDA could be delayed while additional trials are
performed or the project could be abandoned. Such trials would add significant
new costs to such a program, which would have a material adverse effect on the
Company's business, financial condition and results of operations.
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If accepted for filing, the applications are further reviewed first by the
FDA staff and, if appropriate, subsequently by an FDA scientific advisory panel
comprised of physicians and others with expertise in the relevant field. A
public meeting is held before the advisory panel in which the PMA or NDA
application is reviewed and discussed. The scientific advisory panel then issues
a recommendation of approval or denial to the FDA or recommends approval with
conditions. Although the FDA is not bound by the opinion of the advisory panel,
the FDA tends to give considerable weight to panel recommendations. If the FDA's
evaluations of the application are favorable, the FDA will subsequently publish
an order approving the PMA application or NDA application. Interested parties
can file comments on the order and seek further FDA review.
Although by statute the FDA is granted 180 days in which to review a PMA or
NDA and either approve or disapprove it, in practice the FDA has often taken
much longer. Generally, during the review, the FDA will request additional data
and the applicant will agree to extend the review time. The FDA will make an
initial assessment as to whether the PMA or NDA is sufficiently complete for
review and may require the development and submission of additional data or
analysis. The PMA and NDA processing in the past has typically lasted more than
a year from the time of filing, and in some cases several years, but the FDA is
being pressured to meet its statutory timelines. Many such reviews are now being
completed within six months, but others are not, and there is no assurance when
or if an application will be approved.
New PMA applications or PMA supplements are required for certain
modifications to a device that is approved through the PMA process. Supplements
to a PMA application often require submission of the same type of information as
for a PMA application except that the supplement is limited to information
needed to support any changes from the product covered by the original PMA
application and may not require the submission of clinical data or the convening
of an advisory committee and corresponding review. In addition, certain changes,
including changes to the labeling, manufacturing, dosage, or route of
administration of an approved new drug require the approval of a supplement to
the NDA application prior to initiating such changes. Submission of significant
NDA supplements often require data similar to that submitted with the original
NDA application. Likewise, with respect to the implantable pump and insulin
combination product, certain changes to the product (e.g., design, labeling,
manufacturing, dosage, route of administration) would require FDA's approval of
a supplement to the original application. At the present time, FDA has indicated
that there will be only one holder of the approved application for the pump and
insulin combination product. The holder will be the entity entitled to file such
supplements. The Company is seeking an arrangement with the FDA and Hoechst
whereby the Company would be the approved application holder, but there can be
no assurance that such an arrangement will be achieved. If the Company does not
hold the approved application, then its ability to obtain FDA approval of
modifications to the device would require appropriate contractual arrangements
with Hoechst, or possibly would require obtaining a new PMA, which could have a
material adverse effect on the Company.
The PMA and NDA processes can each be expensive, uncertain and lengthy, and
a number of devices and drugs for which PMA or NDA approval has been sought have
never been approved for marketing. There can be no assurance that the Company
will be able to obtain necessary regulatory approvals or clearances on a timely
basis or at all for any of its products under development, and delays in receipt
of or failure to receive such approvals, the loss of previously received
approvals, or failure to comply with existing or future regulatory requirements
would have a material adverse effect on the Company's business, financial
condition and results of operations.
Approvals restrict devices and drugs to specifically labeled uses, and the
combination pump/insulin product would be similarly restricted. The FDA actively
enforces regulations prohibiting marketing of products for unapproved uses.
The FDA also conducts inspections to determine whether the Company conforms
with GMP, and subsequent GMP inspections will continue after the FDA approval. A
GMP inspection was last completed in February 1995, with only one minor
citation, which has been corrected. A further such inspection may be conducted
relative to any PMA application submitted by the Company for other products or
pursuant to the FDA's practice of performing periodic inspections.
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Failure to comply with applicable regulatory requirements can result in,
among other things, fines, injunctions, civil penalties, failure of the
government to grant premarket clearance or premarket approval of devices or
drugs, delays or suspensions or withdrawals of approvals, seizures or recalls of
products, operating restrictions and criminal prosecutions. Changes in existing
requirements or adoption of new requirements could have a material adverse
effect on the Company's business, financial condition and results of operations.
The FDA can withdraw an NDA or PMA approval if new evidence or new
information shows the drug or device is no longer safe or effective, or if the
FDA discovers that the NDA or PMA contains any untrue statement of material
fact. Other reasons justifying withdrawal of an NDA or PMA by the FDA include,
but are not limited to, failure to maintain required records or to file records
and reports, new questions regarding manufacturing, and whether labeling is
false or misleading.
Exports of products subject to 510(k) notification requirements, but not
yet cleared to market, are permitted without FDA export approval, provided that
certain requirements are met. Unapproved products subject to PMA requirements
must receive prior FDA export approval unless they are approved for use by any
member country of the EU and certain other countries, including Australia,
Canada, Israel, Japan, New Zealand, Switzerland and South Africa, in which case
they can be exported to any country without prior FDA approval. International
sales are subject to foreign government regulation, the requirements of which
vary substantially from country to country. The time required to obtain approval
by a foreign country may be longer or shorter than that required for FDA
approval, and the requirements may differ. Within the next several years, a
company must obtain the CE Mark prior to sale within the EU of certain medical
devices, including implantable products. During this process, the sponsor must
demonstrate compliance with ISO manufacturing and quality requirements. The
Company received approval for use of its implantable insulin pump in France in
June 1993. In March 1995, the Company obtained the CE Mark to market its
implantable pump throughout the EU, but full commercial distribution of the
Company's implantable pump in the EU will be limited until the special insulin
required for use in the pump is approved and made available. See
"-- Products -- Current Products -- Implantable Insulin Pump." In March 1995,
the Company received certification under applicable ISO 9002 quality standards
and in July, 1996 received certification under ISO 9001 design control
standards. As is the case with GMP inspections in the U.S., inspections by
foreign bodies will continue in the EU on a periodic basis after receipt of the
CE Mark.
The Company also is subject to numerous federal, state and local laws
relating to such matters as safe working conditions, manufacturing practices,
environmental protection, fire hazard control and disposal of hazardous or
potentially hazardous substances. Additionally, the Company must comply with
various FDA, and in some cases Federal Trade Commission, requirements for
design, safety, advertising, labeling, record keeping and reporting of adverse
experiences with the use of a product. There can be no assurance that the
Company will not be required to incur significant costs to comply with such laws
and regulations in the future or that such laws or regulations will not have a
material adverse effect upon the Company's ability to do business.
External pumps have generally qualified for clearance under Section 510(k),
although certain features of advanced pumps may require clinical validation. The
Company's Models 507 and 506 external pumps have all been cleared by the FDA
pursuant to the Section 510(k) premarket notification process and a 510(k)
notification has been submitted with respect to Model 505. Modifications or
enhancements to the Company's products that are cleared through the 510(k)
process that could significantly affect safety or effectiveness will require new
submissions. The Company has made certain changes to its cleared devices which
the Company believes do not require the submission of new 510(k) notifications.
However, there can be no assurance that the FDA will agree with the Company's
determinations and not require the Company to submit new 510(k) notifications
for any of these modifications. The Company believes short term subcutaneous
glucose monitor may be cleared through the 510(k) process after a limited
clinical trial, but there is no assurance that the FDA will not later require
the more stringent PMA application process for such devices.
There can be no assurance that the necessary approvals for the use of new
generations of the Company's external pumps and disposables, the Company's
implantable insulin pump or its glucose monitoring systems will be granted by
the FDA or other authorities on a timely basis or at all, and delays in receipt
of or failure to
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receive such approvals, or the loss of previously received approvals, could
result in significant delays, substantial costs or even the cessation of
operations relating to a product or group of products, and any of these could
have a material adverse effect on the business, financial condition and results
of operations of the Company.
THIRD-PARTY REIMBURSEMENT
In the U.S., the Company's products are generally purchased directly by
patients, physician groups, hospitals, and/or dealers. In many cases the
Company, on behalf of the patients, bills third-party payors, including private
insurance companies, health maintenance organizations, preferred provider
organizations, other managed care providers, and, to a limited extent, Medicaid.
Under the Medicaid program, states generally reimburse for approved procedures
on a reasonable cost or fee schedule basis. Currently, certain states reimburse
for the Company's products under the Medicaid program. Although the Company does
not currently derive revenues from the Medicare program for any of its products,
it is in the process of seeking coverage for its external pump. The Company
believes that the primary value of Medicare coverage for diabetes today is that
it facilitates reimbursement by many other third party payors because they
follow Medicare guidelines. Although, the Clinton Administration's plan to
address the crisis in the Medicare Trust Fund recently announced is directed
toward reducing costs further, it also contains provisions directed specifically
towards expanded coverage for certain chronic diseases, including diabetes.
There is no certainty that these proposals expanding coverage for diabetes will
be enacted or, if so, whether the Company's products would benefit.
The Company maintains an insurance assistance department consisting of 20
people at February 28, 1997 to simplify and expedite claims processing and to
assist patients in obtaining third-party reimbursement. Based upon sales made by
the Company's direct sales force (which represent 42% of the total revenues), in
1995 the Company believes that more than 90% of the revenues from Company's
external pump sales represented reimbursement by third-party payors (subject to
applicable deductible amounts).
Third-party payors may also decline to reimburse for procedures, supplies
or services determined to be not "medically necessary" or "reasonable." Certain
payors have initially indicated that they would decline to reimburse for certain
of the Company's products on that basis. The Company attempts to deter and
reverse such practices through education and has expanded its insurance
assistance efforts toward this end. These efforts are usually successful, but
such reimbursement may become less likely in the future as pressure continues to
mount for lower health care costs.
Medicare and many other third-party payors also do not reimburse for
procedures deemed "experimental" or "investigational." There is usually no
precise date when a procedure ceases to be experimental or investigational, but
devices in clinical investigation under an IDE are usually deemed to be
experimental or investigational. The failure to cover early use of a procedure
deters usage, delaying acceptance even longer. Use of implantable pumps is still
considered to be an investigational procedure by many third-party payors in the
U.S. and reimbursement for the small number of pumps sold in the U.S. has
therefore been limited to date.
There is widespread concern that health care market initiatives in the U.S.
may lead third-party payors to decline or further limit reimbursement. The
extent to which third-party payors may determine that use of the Company's
products will save costs or will at least be cost effective is highly uncertain,
and it is possible, especially for diabetes, that they will merely focus on the
lower initial costs associated with injection therapy or will otherwise limit
reimbursement for insulin pumps or other products developed by the Company.
Because of uncertainties regarding the possible health care reform measures that
could be proposed in the future and initiatives to reduce costs by private
payors, the Company cannot predict whether reimbursement for the Company's
products will be affected or, if affected, the extent of any effect. The
unavailability of third-party coverage or the inadequacy of reimbursement for
the Company's products would materially and adversely affect the Company's
business, financial condition and results of operations.
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PRODUCT LIABILITY AND WARRANTIES
The Company's products are generally warranted for various periods ranging
from two to four years. The special motors contained in the Company's external
pumps are warranted for life. The Company sets aside a reserve based on monthly
return rates to pay for customer service and repair of products. Additional
reserves are set aside during early stages of product introduction. The Company
believes such reserves to be adequate, but in the event of a major product
problem or recall, the reserves may be inadequate to cover all costs, and such
event could have a material adverse effect on the Company's business, financial
condition and results of operations.
The Company's business involves the inherent risk of product liability
claims. The Company maintains product liability insurance with coverage limits
of $15 million per occurrence and an annual aggregate maximum of $15 million,
with a deductible of $25,000 per occurrence. There can be no assurance that this
insurance coverage will continue to be available on terms acceptable to the
Company or that such coverage will be adequate for liabilities actually
incurred.
EMPLOYEES
As of February 28, 1997, the Company employed 373 full-time persons, plus
34 temporary employees, including 66 in research and development, 145 in
manufacturing, production engineering and quality assurance, 74 in
administration and 122 in sales and marketing. The Company believes that the
success of its business depends, in part, on its ability to attract and retain
qualified personnel, particularly qualified scientific, technical and key
management personnel. The Company believes its relationships with its employees
are good.
MEDICAL ADVISORY BOARD
A Medical Advisory Board, consisting of five individuals with recognized
expertise in fields relating to diabetes care and treatment, has been organized
to advise the Company concerning long-term product planning, research,
development and marketing of its diabetes treatment products. Members of the
Medical Advisory Board consult and meet formally and informally with the
Company. Certain members of the Medical Advisory Board are employed by academic
institutions and may have commitments to or consulting or advisory agreements
with other entities that may limit their availability to the Company. Members of
the Medical Advisory Board may also serve as consultants to other medical
product companies. The members of the Medical Advisory Board have agreed,
however, to maintain the confidentiality of all proprietary information
disclosed to them by the Company. In addition, any ideas, inventions,
developments, improvements and works of authorship developed by the members of
the Medical Advisory Board relating to insulin pumps or glucose sensors are the
property of the Company. Currently, the following persons comprise the Company's
Medical Advisory Board:
Jay S. Skyler, M.D. (Chairman), is a Professor of Medicine, Pediatrics and
Psychology at the University of Miami in Miami, Florida, past President of the
American Diabetes Association, and current Vice-President of the International
Diabetes Federation. Dr. Skyler is the Chairman for the NIH-sponsored
Multi-center Diabetes Prevention Trial. Dr. Skyler is the author of numerous
research and review articles, many of which focus on the complications of
diabetes and the risk reduction of such with intensive diabetes management.
Irl B. Hirsch, M.D., is Associate Professor of Medicine at the University
of Washington School of Medicine in Seattle, Washington and the Medical Director
of the Diabetes Care Center at the University of Washington in Seattle,
Washington. Dr. Hirsch has been an Associate Editor for Clinical Diabetes (a
medical journal specializing in diabetes) since 1992 and is a reviewer for
several scientific and medical journals. From 1993, he has been a consultant to
the Diabetes Control Project in the state of Washington. He is the author of
numerous articles covering topics such as use of insulin pump therapy to treat
hypoglycemia, insulin treatment during surgery and an update on insulin therapy
for family practitioners. Dr. Hirsch recently published a book with the ADA for
individuals with diabetes entitled, How To Get Great Diabetes Care: What You and
Your Doctor Can Do to Improve Your Medical Care--And Your Life. Dr. Hirsch has
diabetes and uses the Company's Model 507 insulin pump.
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Francine Ratner Kaufman, M.D. is an Associate Professor of Pediatrics at
the University of Southern California School of Medicine. Dr. Kaufman was past
President of the Board of Directors of the Los Angeles Chapter of the ADA
(1988-1990, 1993-1994) and is President of the Board of Directors of the
California affiliate of the ADA. She is a member of the national ADA Board of
Directors, where she is on the Professional Practice Committee and a member of
the Clinical Initiatives Committee of the Endocrine Society. For the past five
years, she has been an associate editor for Clinical Diabetes.
Christopher D. Saudek, M.D., is Professor of Medicine at The Johns Hopkins
University School of Medicine and a leader in the field of implantable pump
therapy. Dr. Saudek began working on implantable insulin pump therapy with a
predecessor of the Company in the early 1980's, implanted the first MiniMed pump
in 1987 and was the principal investigator in the Company's clinical trials of
its MIP 2001. Dr. Saudek received the Clinician of the Year Award from the ADA
in 1991.
Robert J. Tanenberg, M.D., FACP, is Clinical Associate Professor of
Medicine at Georgetown University School of Medicine, Washington, D.C. and
senior attending physician at Washington Hospital Center in Washington, D.C. Dr.
Tanenberg is on the Medical Advisory Board for the Washington, DC Chapter of the
Juvenile Diabetes Foundation. He is an investigator in the Company's implantable
pump trials. Dr. Tannenberg was formerly the Chairman of the ADA's Council on
Health Care Delivery and Public Health.
ITEM 2. PROPERTIES
The Company owns its current primary facilities with an aggregate of
approximately 175,000 square feet in Sylmar, California. The Company currently
occupies approximately 150,000 square feet of such facilities. The Company
intends to use up to $2 million of the proceeds of a public offering of common
stock contemplated by a recent Prospectus to upgrade the structure of its
principal buildings in order to comply with recently adopted local building code
requirements for earthquake protection. Approximately 23,400 square feet of the
remaining space is leased to Alfred E. Mann, the Company's Chairman and Chief
Executive Officer. The Company believes that its facilities are adequate to meet
its foreseeable requirements for its existing products through at least the end
of 1998, without any requirement to expand into additional space.
ITEM 3. LEGAL PROCEEDINGS
In September 1996, the Company filed an action against Fimed, Inc.
("Fimed") in Los Angeles County Superior Court seeking declaratory relief and
rescission of a distributorship agreement giving Fimed an exclusive right to
distribute the Company's external pumps using third-party consumer financing.
The Company alleged that Fimed fraudulently induced the Company to enter into
the agreement and failed to disclose material facts. Fimed answered the
Company's complaint generally denying the allegations but also asserted
counterclaims against the Company alleging breach of contract, promissory fraud,
unfair competition, intentional interference with prospective economic
advantage, defamation (libel and slander) and abuse of process and seeking
compensatory damages of $600 million and punitive damages of $300 million. No
significant amount of the Company's products has ever been sold using
third-party consumer financing, and Fimed never made any sales under the
agreement. The Company notified Fimed that the Company was seeking rescission of
the agreement less than six months after it was signed and before Fimed began
marketing the Company's products. The Company believes that it has meritorious
defenses to the counterclaim asserted by Fimed. The Company intends to prosecute
its claim against Fimed and defend against the counterclaim vigorously.
Discovery has commenced in the litigation, but the matter has not yet been set
for trial.
The Company is not presently a party to any other material pending legal
proceedings. The Company may be subject from time to time to various other legal
proceedings, including product liability claims, which arise in the ordinary
course of its business. The Company believes that none of such proceedings,
individually or in the aggregate, are likely to have a material adverse effect
on its business or financial condition.
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ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
There were no matters submitted to a vote of the security holders of the
Company, either through solicitation of proxies or otherwise, during the fourth
quarter of the fiscal year ended December 27, 1996.
EXECUTIVE OFFICERS OF THE REGISTRANT
The Company's Executive Officers are generally elected annually by the
Board of Directors for a one year term and serve at the pleasure of the Board.
As of March 21, 1997, the Company's executive officers are:
NAME AGE POSITIONS WITH THE COMPANY
- ------------------ --- --------------------------------------------------------
Alfred E. Mann 71 Chairman of the Board and Chief Executive Officer
Terrance H. Gregg 48 President and Chief Operating Officer
Eric S. Kentor 37 Senior Vice President, General Counsel and Secretary
Kevin R. Sayer 39 Senior Vice President, Finance and Chief Financial
Officer
Clifford W. Hague 41 Vice President, Marketing and Business Development
William Arthur 45 Vice President, Sales
John H. Livingston 50 Vice President, Research, Development and Engineering
Noory Shaolian 55 Vice President, Instrument Manufacturing and Service
Alfred E. Mann has served as Chairman of the Board and Chief Executive
Officer of the Company since its incorporation and was President until 1994 and
from October 1995 until October 1996. Until March 1994, Mr. Mann served as the
Chairman of the Board of the General Partner of MMTL, a predecessor of the
Company, which was also engaged in the design, manufacture and marketing of
hospital intravenous pumps and electrostimulation devices primarily for
restoration of hearing for the deaf. Mr. Mann has also served as Chairman of
Advanced Bionics since 1994 and as CEO from 1994 to February 1996. Advanced
Bionics is the successor to the electrostimulation business segment of MMTL.
From 1985 to September 1992, Mr. Mann was also President and CEO of
Siemens-Pacesetter, Inc., a manufacturer and distributor of cardiac pacemakers.
Mr. Mann founded and from 1972 until 1985 was Chairman of the Board and CEO of
Pacesetter Systems, Inc., a California corporation and predecessor of
Siemens-Pacesetter, Inc. Prior to 1972, he was President of Spectrolab, an
electro-optical and aerospace systems company, and Heliotek, a semiconductor and
electro-optical components manufacturer, which companies Mr. Mann founded in
1956 and 1960, respectively, and which were sold to Textron Inc. in 1960. Mr.
Mann is currently Chairman of the Board of Trustees of the Alfred E. Mann
Foundation, a medical research foundation. Mr. Mann holds a B.A. and an M.S.
degree in physics from the University of California, Los Angeles.
Terrance H. Gregg was promoted to Executive Vice President, Operations in
February 1996 and to President and Chief Operating Officer in October 1996. Mr.
Gregg joined the Company as Vice President of Regulatory Affairs and Clinical
Research in September 1994. Prior to employment with the Company, Mr. Gregg
spent the preceding nine years as Vice President of Governmental Affairs for
Ioptex Research, the ophthalmic surgical products subsidiary of Smith & Nephew,
plc. Prior to joining Ioptex Research, Mr. Gregg was responsible for Regulatory
Affairs, Clinical Research and Quality Assurance for divisions of Allergan, Inc.
Mr. Gregg earned a B.S. degree in zoology from Colorado State University in
1971.
Eric S. Kentor was promoted to Senior Vice President in February 1996. Mr.
Kentor joined the Company in May 1995 as Vice President, General Counsel and
Secretary. Prior to joining the Company, Mr. Kentor was Vice President, Legal
Services, of Health Net, California's second largest health maintenance
organization, where he held various positions beginning in March 1994. From
March 1994 until May 1995, Mr. Kentor also served as Executive Counsel of Health
Net's parent corporation, Health Systems International, Inc. Previously, from
1987 until 1994, Mr. Kentor practiced with the law firm of McDermott, Will &
Emery, where he was elected partner in 1992. Mr. Kentor received a J.D. degree
from the UCLA School of Law in 1986.
Kevin R. Sayer was promoted to Senior Vice President, Finance, in February
1996. Mr. Sayer joined the Company in May 1994 as Vice President, Finance and
Chief Financial Officer. Prior to joining the Company,
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Mr. Sayer spent the previous 11 years with Ernst & Young, where he specialized
in providing auditing, accounting and consulting services to high growth
companies, primarily in the health care and high technology industry segments.
Mr. Sayer received a B.S. in accounting from Brigham Young University in 1981
and received a Masters degree in accounting/information systems from Brigham
Young University in 1983.
William Arthur has served as Vice President, Sales, since March 1995.
Previously Mr. Arthur served from July 1993 to February 1995 as the Company's
Vice President, Sales and Marketing. He joined the Company in July 1993 after
serving as President and CEO of Med-Fusion Inc., a subsidiary of Medex, Inc. and
a manufacturer of ambulatory infusion pumps. Mr. Arthur founded Med-Fusion Inc.
in 1984 and remained as its Chief Executive Officer after its acquisition by
Medex in 1988. Prior to his employment with Med-Fusion, Mr. Arthur served as
Director of Marketing for infusion systems for Pacesetter Systems, Inc.
Previously Mr. Arthur served as Vice President of Sales and Marketing for
Auto-Syringe, a subsidiary of Baxter International, an earlier competitor of a
predecessor of the Company. Mr. Arthur received a B.S. degree in microbiology
from Pennsylvania State University in 1973.
Clifford W. Hague has served as Vice President, Marketing and Business
Development, since March 1995. From February 1993 until March 1995, Mr. Hague
was Vice President, Marketing and Clinical Research, of VIA Medical Corporation,
an early-stage company developing a series of sensor systems primarily for
hospital use. Previously, from October 1991 to January 1993, Mr. Hague served as
Vice President, Marketing of Siemens Infusion Systems ("SIS") and before that,
Director of Marketing of MiniMed Technologies, a predecessor of both SIS and the
Company. Before joining MiniMed Technologies in January 1986, Mr. Hague was a
product manager at Parker-Hannifin, Biomedical Division. Mr. Hague received an
M.B.A. degree from the University of California, Irvine in 1983, and a B.S.
degree in zoology from the University of California, Davis, in 1980.
John H. Livingston has been Vice President, Research, Development and
Engineering of the Company and its predecessors since May 1985. Mr. Livingston
served as Director, Research, Development and Engineering at IMED Corporation
from November 1983 until May 1985. From January 1978 until November 1983, Mr.
Livingston worked at Cordis Corporation, where for the final two years he was
Manager, Instrument and Software Design, for the Implantables Product
Engineering Division, responsible for the design and development of electronic
hardware and software for implantable medical electronic systems. Mr. Livingston
received his B.S. degree in electrical engineering from Yale University and both
an M.S. degree in electrical engineering and a J.M. degree from Stanford
University in 1975.
Noory Shaolian has been Vice President in charge of Instrument
Manufacturing and Service since joining the Company in June 1992. From 1991 to
June 1992, Mr. Shaolian pursued private real estate investments. Previously,
from 1983 to 1991 he was Vice President of Manufacturing and Service at
Mitsubishi Electronics, a manufacturer of personal and lap-top computers. Mr.
Shaolian is a Certified Quality Engineer. His education includes a B.S. degree
in mechanical engineering from California Polytechnic University, San Luis
Obispo, and an M.S. degree in business administration from California State
University at Los Angeles.
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PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCK HOLDER MATTERS
The Company's common stock commenced trading on the Nasdaq National Market,
under the symbol "MNMD" on July 25, 1995. The following table sets forth, for
the fiscal quarters indicated the intra-day high and low sales prices per share
of the Company's common stock on the Nasdaq National Market.
HIGH LOW
------ ------
1996
Fourth Quarter Ended December 27, 1996...................... $32.75 $23.50
Third Quarter Ended September 27, 1996...................... 29.75 18.25
Second Quarter Ended June 28, 1996.......................... 33.75 16.25
First Quarter Ended March 29, 1996.......................... 18.25 12.25
1995
Fourth Quarter Ended December 29, 1995...................... $13.38 $ 7.75
Third Quarter Ended September 29, 1995 (from July 25,
1995)..................................................... 13.50 8.75
RECORD HOLDERS
As of March 19, 1997, the number of record holders of the Company's Common
Stock was 275.
DIVIDENDS
The Company has never paid a cash dividend on its Common Stock. The Company
currently anticipates that, for the foreseeable future, any earnings will be
retained for use in its business and, accordingly, does not currently anticipate
the payment of any cash dividends. The payment of dividends by the Company, if
any, will be at the discretion of the Company's Board of Directors, and will
depend upon the Company's earnings, financial position, capital requirements and
such other factors as the Company's Board of Directors deems relevant.
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ITEM 6. SELECTED CONSOLIDATED FINANCIAL DATA
The following table summarizes certain selected consolidated financial
data, which should be read in conjunction with the Company's financial
statements and notes thereto included elsewhere herein and with "MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS." The
selected consolidated financial data as of December 27, 1996, December 29, 1995
and December 31, 1994, 1993 and 1992, and for each of the five fiscal years in
the period ended December 27, 1996 have been derived from the Company's audited
financial statements, which have been audited by Deloitte & Touche LLP, the
Company's independent auditors. Other information has been derived from other
audited financial statements.
DATA OF
PREDECESSOR
ENTITIES(1)
----------- YEAR ENDED YEAR ENDED
YEARS ENDED DECEMBER 31, DECEMBER 29, DECEMBER 27,
--------------------------------- ------------- -------------
1992 1993 1994 1995 1996
----------- ------- --------- ------------- -------------
(IN THOUSANDS, EXCEPT PER SHARE DATA)
STATEMENT OF OPERATIONS DATA:
Net sales............................... $24,079 $31,731 $ 36,274 $ 45,107 $ 59,080
Cost of sales........................... 13,618 14,947 16,131 16,531 20,440
------- ------- ------- ------- -------
Gross profit............................ 10,461 16,784 20,143 28,576 38,640
Operating expenses:
Selling, general and administrative... 10,108 14,088 15,366 19,863 25,468
Research and development.............. 3,891 3,998 5,372 7,095 7,900
------- ------- ------- ------- -------
Total.............................. 13,999 18,086 20,738 26,958 33,368
------- ------- ------- ------- -------
Operating income (loss)................. (3,538) (1,302) (595) 1,618 5,272
Interest expense........................ (172) (410) (533) (352) --
Other income, including interest
income................................ 29 154 228 965 1,062
------- ------- ------- ------- -------
Income (loss) before income taxes ...... (3,681) (1,558) (900) 2,231 6,334
Provision for income taxes.............. -- -- -- 422 1,662
======= ======= ======= ======= =======
Net income (loss)....................... $(3,681) $(1,558) $ (900) $ 1,809 $ 4,672
======= ======= ======= ======= =======
Net income (loss) per share(2).......... $ (0.10) $ 0.17 $ 0.38
======= ======= =======
Weighted average number of common and
common equivalent shares used in
computing net income (loss) per
share(2).............................. 9,085,000 10,587,000 12,238,000(3)
======= ======= =======
BALANCE SHEET DATA:
Working capital........................... $ 8,879 $ 9,026 $14,317 $ 32,695 $ 37,209
Total assets.............................. 16,998 19,068 24,510 52,529 59,503
Notes payable, net of current portion..... -- 7,286 7,000 -- --
Redeemable, convertible preferred stock... -- -- 8,513 -- --
Retained earnings (accumulated deficit)... -- (1,558) (2,962) (1,664) 3,008
Total stockholders' equity................ -- 4,005 2,022 42,362 49,626
Net assets................................ 5,563 -- -- -- --
- ---------------
(1) The financial data presented for all periods subsequent to the Company's
incorporation in 1993 reflect the operations of the medication infusion
business of the Company as an independent entity. The financial data for
1992 reflect the operations of that business as a business unit within two
limited partnerships as if the Company were a separate entity.
(2) Pursuant to applicable rules, and because of the significant change in the
Company's capital structure related to the conversion of preferred stock as
a result of the Company's initial public offering of common
26
27
stock in 1995, per share information and weighted average shares outstanding
are presented only for the three years in the period ended December 27,
1996.
(3) Includes 1,456,146 shares of Common Stock issuable upon exercise of
outstanding stock options with a weighted average exercise price of $7.81
per share.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
GENERAL
The Company has focused its efforts on three product lines: external pumps
and related disposables, implantable insulin pumps and continuous glucose
monitoring systems. There have been no sales of glucose monitoring systems to
date. Sales activity of the implantable insulin pump, primarily in Europe, where
the product is approved for commercial distribution, is in an early stage.
RESULTS OF OPERATIONS
The following table sets forth for the years indicated the percentage
relationship to net sales of certain items in the Company's consolidated
statements of operations and the percentage changes in the dollar amounts of
such items on a comparative basis.
ANNUAL %
INCREASE (DECREASE)
PERCENTAGE OF NET SALES ---------------------
------------------------- 1995 1996
1994 1995 1996 VS. 1994 VS. 1995
----- ----- ----- -------- --------
Net sales........................................ 100.0% 100.0% 100.0% 24.4% 31.0%
Cost of sales.................................... 44.5 36.6 34.6 2.5 23.6
----- ----- ----- ---- -----
Gross profit..................................... 55.5 63.4 65.4 41.9 35.2
Operating expenses:
Selling, general and administrative............ 42.4 44.0 43.1 29.3 28.2
Research and development....................... 14.8 15.7 13.4 32.1 11.3
----- ----- ----- ---- -----
Total operating expenses............... 57.2 59.7 56.5 29.9 23.8
----- ----- ----- ---- -----
Operating income (loss).......................... (1.7)% 3.7% 8.9% -- 225.8%
===== ===== ===== ==== =====
27
28
NET SALES
The following table sets forth domestic and international net sales, gross
profits and research and development expenditures related to the Company's three
primary product lines for the three years in the period ended December 27, 1996.
DOLLARS IN THOUSANDS % OF NET SALES
------------------------------- -------------------------
1994 1995 1996 1994 1995 1996
------- ------- ------- ----- ----- -----
NET SALES
External pumps and related
disposables
Domestic........................... $29,980 $37,299 $50,688 82.6% 82.7% 85.8%
International...................... 4,798 5,493 6,396 13.3 12.2 10.8
------- ------- ------- ----- ----- -----
Subtotal................... $34,778 $42,792 $57,084 95.9 94.9 96.6
Implantable pumps
Domestic........................... 233 151 -- 0.6% 0.3% --
International...................... 960 2,164 1,996 2.7 4.8 3.4
Subtotal................... 1,193 2,315 1,996 3.3 5.1 3.4
------- ------- ------- ----- ----- -----
Other net sales...................... 303 -- -- 0.8 -- --
------- ------- ------- ----- ----- -----
Total...................... $36,274 $45,107 $59,080 100.0% 100.0% 100.0%
======= ======= ======= ===== ===== =====
GROSS PROFITS
External pumps and related
disposables........................ $21,269 $28,017 $39,044 58.6% 62.1% 66.1%
Implantable pumps.................... (1,429) 559 (404) (3.9) 1.3 (0.7)
Other................................ 303 -- -- 0.8 -- --
------- ------- ------- ----- ----- -----
Total...................... $20,143 $28,576 $38,640 55.5% 63.4% 65.4%
======= ======= ======= ===== ===== =====
RESEARCH AND DEVELOPMENT EXPENSES
External pumps and related
disposables........................ $ 1,355 $ 2,445 $ 3,381 3.7% 5.4% 5.8%
Implantable pumps.................... 2,568 2,928 2,683 7.1 6.5 4.5
Glucose monitoring systems........... 1,449 1,722 1,836 4.0 3.8 3.1
------- ------- ------- ----- ----- -----
Total...................... $ 5,372 $ 7,095 $ 7,900 14.8% 15.7% 13.4%
======= ======= ======= ===== ===== =====
FISCAL YEARS ENDED DECEMBER 27, 1996 AND DECEMBER 29, 1995
Net Sales. Net sales increased 31.0% in 1996 over 1995 to $59,080,000 from
$45,107,000. This increase is principally the result of an increase of 33.4%, or
$14,292,000, in the sales volume of external pumps and related disposables.
Domestic sales of these products grew 35.9%, or $13,389,000, from 1995 to 1996,
while international sales increased 16.4%, or $903,000. The domestic sales
increase was primarily the result of increased sales volume of external pumps
and related disposables, with external pump sales growing at a rate in excess of
disposable product sales. Additionally, net sales increased due to a customer
shift to more expensive disposable products (principally the Sof-set QR) offered
by the Company since June 1995, with enhanced features and commensurately higher
sales prices. With the introduction of the Company's new Model 507 insulin pump
in June 1996, the domestic average sales prices on external pumps increased,
while the related disposable products experienced relative price stability.
International sales of external pumps and related disposables for 1996 and
1995 include the sale of external pumps to Novo Nordisk A/S, which previously
manufactured an external insulin pump and related disposables that were sold in
Europe. Under an agreement with the Company entered into in late 1993, the
external insulin pumps that Novo Nordisk previously manufactured and sold were
replaced with the Company's external insulin pumps. Sales of external pumps to
Novo Nordisk represented 15.5% of international sales of external pumps and
related disposables in 1996, while such sales represented 23.1% of international
sales of these products in 1995. The decline in sales to Novo Nordisk in 1996
reflects the completion of the contractually determined delivery schedule with
Novo Nordisk during the quarter ended June 28, 1996.
28
29
Sales of implantable pumps decreased by $319,000, or 13.8%, in 1996 over
1995. Due to problems encountered with the special insulin formulation
manufactured by Hoechst and used in the implantable pump, such sales were
limited during 1996. Although the Company received certification under the
applicable directives issued by the EU and received the CE Mark in March 1995
for the implantable pump (permitting commercial sale throughout the EU),
separate approval from the EU is required for commercial sale of the insulin.
Hoechst, the manufacturer of that insulin, has applied for such approval. Such
approval has not yet been received and no assurance can be given that such
approval will be received. Future sales of the Company's implantable insulin
pumps may be adversely affected by the lack of availability of the special
insulin utilized in the implantable pump, as well as any delay or denial of
regulatory approval for the insulin, seasonality, and overall market acceptance
of this product line.
The Company and Hoechst are continuing their testing of the special insulin
for use in the implantable pump. No assurance can be given as to the potential
for success of these efforts. If such efforts are not successful, the business,
results of operations or financial condition of the Company could be materially
adversely affected. In order for the implantable pump to be authorized for sale
in the U.S., the Company must work with Hoechst under a procedure established by
the FDA for approval of a combined application for the Company's pump and the
Hoechst insulin. The Company has completed preparation of the PMA element of the
application for the implantable pump and is assisting Hoechst in the preparation
of the NDA element of the application for this special insulin. Delay or failure
to obtain FDA approval could have a material adverse effect on the Company's
business, results of operations or financial condition. See
"BUSINESS -- Products -- Current Products -- Implantable Insulin Pump" and
"BUSINESS -- Government Regulation."
Cost of Sales and Operating Expenses. Cost of sales increased 23.6% in 1996
over 1995 to $20,440,000 from $16,531,000. As a percentage of net sales, cost of
sales decreased to 34.6% in 1996 from 36.6% in 1995. Increased sales volume
enabled the Company to spread its fixed manufacturing costs over a larger sales
base and thereby achieve certain economies of scale. The Company has continued
to implement manufacturing efficiency programs that reduced per unit labor,
overhead and materials costs. Additionally, the Company achieved lower product
costs for certain disposable products by bringing the manufacturing processes
in-house during 1996. Cost of sales in 1996 included manufacturing start-up
expenses related to the Company's June 1996 release of its latest generation
external insulin pump, the Model 507. Gross margins on the external pumps and
related disposables increased to 66.1% of sales in 1996, compared to 62.1% in
1995. The Company's gross profits have been adversely impacted by the
implantable pump product line during 1996 due to continued unpredictable sales,
which have inhibited the Company's ability to realize manufacturing efficiencies
on this product line. The Company expects this trend to continue for the
foreseeable future.
Selling, general and administrative expenses increased 28.2% in 1996 over
1995 to $25,468,000 from $19,863,000. As a percentage of net sales, these
expenses decreased to 43.1% in 1996 from 44.0% in 1995. Selling, general and
administrative expenses increased primarily due to higher external pump and
related disposable sales volume, the introduction of the Model 507 external
insulin pump, increased efforts to educate patients, professionals and payors in
the intensive management of diabetes, and increased spending in international
sales and marketing operations. Increased international expenses related
primarily to bringing in-house to the Company's French subsidiary certain
administrative functions that had been previously performed by a third party and
the organizational and continuing start-up costs of the Company's German
subsidiary, which was formed in December 1995.
Research and development expenses increased 11.3% in 1996 over 1995 to
$7,900,000 from $7,095,000. As a percentage of sales, research and development
expenses decreased to 13.4% in 1996 from 15.7% in 1995. The increase in expenses
is primarily the result of greater resources directed to the design and
introduction of the Company's Model 507 external insulin pump and increased
development of the continuous glucose monitoring systems. Expenses related to
the implantable insulin pump product line decreased in 1996, as the Company
awaited approval of the special insulin required for this product. The Company
anticipates that future research and development expenditures will include
amounts for the further development of the Company's existing technologies for
use in other medical conditions.
29
30
Other. Other income for 1996 and 1995 consists primarily of interest income
generated from the Company's cash, cash equivalents, and short-term investment
balances. The Company incurred interest expense in 1995 and 1994. No interest
expense was incurred, however, during 1996 as all debt had been retired in
connection with the Company's July 1995 initial public offering.
The Company's effective tax rate for 1996 has been computed giving
consideration to the pretax earnings and losses applicable to the Company's
foreign and domestic tax jurisdictions and a continual decrease in the Company's
valuation allowance against net deferred tax assets due to improved operating
results. During 1995, the Company utilized all of its net operating loss
carryforwards. The Company anticipates that future income tax rates for
financial statement purposes will be lower than statutory state and federal
income tax rates, as future income tax payments will be offset by the
recognition of deferred income tax assets related to differences between
financial reporting and income tax reporting requirements. The Company has not
incurred any material foreign income tax expense to date. Inflation has not
significantly impacted the Company's results of operations for the past three
years.
FISCAL YEARS ENDED DECEMBER 29, 1995 AND DECEMBER 31, 1994
Net Sales. Net sales increased 24.4% in 1995 over 1994 to $45,107,000 from
$36,274,000. The 1995 growth in net sales of external pumps and related
disposables amounted to $8,014,000, or 23.0%, over such sales in 1994 due to
growth in both the domestic and international markets. Domestic sales of these
products grew 24.4%, or $7,319,000, from 1994 to 1995, while international net
sales increased 14.5%, or $695,000.
The domestic net sales increase for 1995 resulted from increased sales
volume of external pumps and related disposables, with disposable sales growing
at a rate in excess of external pump sales. The effect of the increased sales
volume achieved in 1995 was somewhat offset by lower average sales prices
obtained on the sale of pumps. However, the related disposable products
experienced a price increase during 1995. Domestic sales of external insulin
pumps to previous pump users continued to decrease as a percentage of total
domestic sales. As a result of this trend, the overall installed base of pump
users increased at a faster rate than in prior periods. The 1995 international
net sales increase was primarily the result of increased sales volume of pumps
and related disposables to foreign distributors. The increase in international
sales volume was partially offset by a scheduled decrease in sales under the
Company's contract with Novo Nordisk. Sales of external insulin pumps to Novo
Nordisk represented 23.1% of international sales of external pumps and related
disposables in 1995, while such sales represented 47.1% of international sales
of these products in 1994.
Sales of implantable pumps increased by $1,122,000, or 94.0%, in 1995 over
1994. Due to problems encountered with the special insulin formulation
manufactured by Hoechst and used in the implantable pump, such sales were
limited to replacements for existing patients during the last half of 1994 and
the first half of 1995. New patient implants for Europe slowly recommenced in
the second half of 1995 when the Company received certification under the
applicable directives issued by the EU and received the CE Mark in March 1995
for the implantable pump.
Cost of Sales and Operating Expenses. Cost of sales increased 2.5% in 1995
over 1994 to $16,531,000 from $16,131,000. As a percentage of net sales, cost of
sales in 1995 decreased to 36.6% from 44.5% in 1994. Increased sales volume
enabled the Company to spread its fixed manufacturing costs over a larger sales
base. Gross margins on the primary product line increased to 62.1% of sales in
1995, compared to 58.6% for this product line in 1994. Gross margins on the
implantable pump product line were positive for 1995 due to the increased sales,
compared to negative gross margins on the implantable pump in 1994.
Selling, general and administrative expenses increased 29.3% in 1995 over
1994 to $19,863,000 from $15,366,000. As a percentage of net sales, these
expenses increased to 44.0% in 1995 from 42.4% in 1994. Higher sales volume in
1995 was the most significant factor in the increase in selling expenses,
primarily attributable to increased commissions and other variable costs related
to the field sales force. Additional increases in selling expenses relate to the
Company's increased focus upon training and education of patients, health care
professionals and third party payors. General and administrative expenses also
increased in 1995 over 1994. These increased costs related primarily to the
development of the Company's accounting, finance,
30
31
MIS, legal and human resources departments to support the Company's growth and
the requirements as a public reporting company.
Research and development expenses increased 32.1% in 1995 over 1994 to
$7,095,000 from $5,372,000. As a percentage of sales, research and development
expenses increased to 15.7% in 1995 from 14.8% in 1994. The 1995 increase is
primarily the result of greater resources directed to all of the Company's
product lines. The Company increased research and development expenses related
to the external pump and disposables to further the development of its next
generation external insulin pump and several new disposable products. Increased
research and development expenses were also incurred for the implantable pump
and the continuous glucose monitoring systems.
Other. Interest expense in 1994 and 1995 related to a $7,000,000 note
payable retired in 1995 with proceeds from the Company's initial public
offering. Other income in 1994 and 1995 related primarily to interest income
generated from the Company's cash, cash equivalents, and short-term investments
balances, with the 1995 increase related to increased funds available as a
result of the initial public offering.
LIQUIDITY AND CAPITAL RESOURCES
During the years ended 1996 and 1995, the Company used cash in operations
of $336,000 and $1,001,000, respectively. While the Company was profitable in
both years, the Company's operating activities used cash, as receivables and
inventories increased significantly. The receivables increase relates to several
factors, including the extension of more favorable credit terms for some key
distributors, increased sales to be reimbursed to the Company by third-party
payors (which typically have longer collection cycles) and the overall sales
volume increase. Because the Company experienced some product shortages during
1995, primarily related to its disposable products, the Company increased
inventories in 1995 and 1996 to better serve its customers. The Company believes
that maintaining increased inventories of these products and other key
components will enable the Company to better meet customer demands. Expenditures
on inventories have also increased in 1996 as a result of the Company's
purchases of significant quantities of component parts for the implantable
insulin pump under a supply agreement entered into in 1996.
Capital expenditures were $1,713,000, $8,700,000 and $4,007,000 for 1994,
1995, and 1996 respectively. The Company's 1995 capital expenditures consisted
primarily of the purchase and improvement of its operating facilities. The
Company's 1996 capital expenditures included continued building improvements,
manufacturing expansion, the acquisition of additional research and development
engineering equipment and information systems requirements. The Company
anticipates that future capital expenditures will increase because of required
repairs and upgrades to its principal facility in compliance with recently
enacted building code provisions applicable to earthquake protection. Capital
expenditures will also increase due to the purchase of manufacturing and other
equipment associated with expanding the Company's product lines and bringing
more manufacturing in-house, as well as the purchase of additional information
systems equipment.
The Company completed its initial public offering of Common Stock in 1995
which generated net proceeds of $29.5 million. There were no significant equity
transactions during 1996. On January 21, 1997, the Company entered into an
unsecured line of credit agreement which enables the Company to borrow up to
$10.0 million through January 31, 1999. The line of credit, if used, bears
interest at an adjustable rate based upon certain commercial paper rates. The
rate on such line of credit was 7.52% as of February 28, 1997. The Company is
required to maintain certain cash, net worth and debt conditions under the
provisions of the credit agreement. The Company is currently in compliance with
all of these conditions.
Management expects that the current level of cash and cash equivalents will
be sufficient to meet its cash needs for working capital and capital
expenditures for at least one year. However the requirements for additional
capital and working capital are subject to change and will depend upon numerous
factors, including the level of capital expenditures, research and development
activities and results, competitive and technological developments, health care
reimbursement trends, and the availability for acquisition by the Company of
complementary additional distribution channels, products, and technologies.
31
32
The Company also is involved in certain litigation, the financial impact of
which is uncertain. See "NOTES TO CONSOLIDATED FINANCIAL STATEMENTS" and "LEGAL
PROCEEDINGS."
QUARTERLY RESULTS
The following table sets forth certain selected consolidated financial
information of the Company for its eight most recent quarters. In the opinion of
management, this unaudited financial information has been prepared on the same
basis as the audited financial information, and includes all adjustments
(consisting only of normal, recurring adjustments) necessary to present this
information fairly when read in conjunction with the Company's Consolidated
Financial Statements and Notes thereto contained elsewhere in this report.
THREE MONTHS ENDED
---------------------------------------------------------------------------------------
MAR. 31, JUNE 30, SEPT. 29, DEC. 29, MAR. 29, JUNE 28, SEPT. 27, DEC. 27,
1995 1995 1995 1995 1996 1996 1996 1996
-------- -------- --------- -------- -------- -------- --------- --------
Net sales.......................... $8,301 $ 10,989 $ 11,007 $ 14,810 $ 12,209 $ 13,343 $ 14,709 $ 18,819
Cost of sales...................... 3,183 3,902 3,963 5,483 4,312 4,571 5,220 6,337
Gross profit....................... 5,118 7,087 7,044 9,327 7,897 8,772 9,489 12,482
Operating expenses:
Selling, general and
administrative................. 4,257 4,934 4,842 5,830 5,324 5,818 6,156 8,170
Research and development......... 1,369 2,005 1,700 2,021 1,822 1,953 1,896 2,229
------ ------- ------- ------- ------- ------- ------- -------
Total operating expenses........... 5,626 6,939 6,542 7,851 7,146 7,771 8,052 10,399
Operating income (loss)............ $ (508) $ 148 $ 502 $ 1,476 $ 751 $ 1,001 $ 1,437 $ 2,083
====== ======= ======= ======= ======= ======= ======= =======
The Company's results of operations have historically fluctuated on a
quarterly basis. These seasonal trends have resulted in sales and earnings for
each of the first three quarters of a given year being less than sales and
earnings for the fourth quarter of the preceding year. These fluctuations have
and will continue to result from numerous factors, including (i) practices of
insurance companies and other third-party payors with respect to reimbursement
for the Company's products, which tends to result in increased sales of the
Company's external infusion pumps later in the calendar year, after patients'
deductibles are satisfied, (ii) market acceptance of the Company's products,
(iii) timing of regulatory approvals, (iv) new product introductions, (v)
competition, (vi) the Company's ability to manufacture its products efficiently
and (vii) timing of research and development expenditures.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
INDEX TO FINANCIAL STATEMENTS
The following independent auditors' report and the consolidated financial
statements of MiniMed Inc. and its subsidiaries are included in Item 8:
Independent Auditors' Report
Consolidated Balance Sheets --
December 29, 1995 and December 27, 1996
Consolidated Statements of Operations --
Years ended December 31, 1994, December 29, 1995 and December 27, 1996
Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity
--
Years ended December 31, 1994, December 29, 1995 and December 27, 1996
Consolidated Statements of Cash Flows --
Years ended December 31, 1994, December 29, 1995 and December 27, 1996
Notes to Consolidated Financial Statements
32
33
INDEPENDENT AUDITOR'S REPORT
To the Shareholders and Board of Directors of MiniMed Inc.:
We have audited the accompanying balance sheets of MiniMed Inc. (the
"Company") as of December 29, 1995 and December 27, 1996, and the related
statements of operations, Convertible Preferred Stock and Stockholders' Equity,
and of cash flows for each of the three years in the period ended December 27,
1996. These financial statements are the responsibility of the Company's
management. Our responsibility is to express an opinion on these financial
statements 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 financial statements present fairly, in all material
respects, the financial position of the Company as of December 29, 1995 and
December 27, 1996, and the results of its operations and its cash flows for each
of the three years in the period ended December 27, 1996 in conformity with
generally accepted accounting principles.
DELOITTE & TOUCHE LLP
Woodland Hills, California
January 17, 1997 (February 20, 1997 as to the last paragraph of note 3)
33
34
MINIMED INC.
CONSOLIDATED BALANCE SHEETS
DECEMBER 29, 1995 AND DECEMBER 27, 1996
ASSETS
1995 1996
----------- -----------
CURRENT ASSETS:
Cash and cash equivalents....................................... $14,762,000 $10,286,000
Short-term investments.......................................... 8,724,000 9,517,000
Accounts receivable, net of allowance for doubtful accounts of
$1,327,000 and $2,575,000 in 1995 and 1996, respectively..... 10,562,000 15,617,000
Receivables due from related entities (Note 3).................. 23,000 90,000
Inventories:
Raw materials................................................ 2,994,000 3,465,000
Work-in-process.............................................. 929,000 1,117,000
Finished goods............................................... 1,242,000 2,143,000
----------- -----------
Total inventories....................................... 5,165,000 6,725,000
Deferred income taxes (Note 10)................................. 1,675,000 3,003,000
Prepaid expenses and other current assets....................... 1,065,000 1,042,000
----------- -----------
Total current assets.................................... 41,976,000 46,280,000
OTHER ASSETS (Note 5)............................................. -- 577,000
LAND, BUILDINGS, PROPERTY AND EQUIPMENT -- Net (Note 4)........... 10,553,000 12,646,000
----------- -----------
TOTAL............................................................. $52,529,000 $59,503,000
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable................................................ $ 1,895,000 $ 1,642,000
Current portion of notes payable and line of credit (Note 6).... 600,000 --
Accrued salaries and related benefits........................... 1,352,000 2,065,000
Accrued sales commissions....................................... 614,000 1,568,000
Accrued warranties.............................................. 3,243,000 2,873,000
Income taxes payable (Note 10).................................. 532,000 463,000
Other accrued expenses.......................................... 1,045,000 460,000
----------- -----------
Total current liabilities............................... 9,281,000 9,071,000
----------- -----------
Deferred income taxes........................................... 886,000 806,000
COMMITMENTS AND CONTINGENCIES (Note 7) STOCKHOLDERS' EQUITY (Notes
1 and 8):
Common stock, par value $.01; 20,000,000 shares authorized;
11,405,933 and 11,636,175 shares issued and outstanding in
1995 and 1996, respectively.................................. 114,000 116,000
Additional capital.............................................. 43,912,000 46,502,000
Retained earnings (Accumulated deficit)......................... (1,664,000) 3,008,000
----------- -----------
Total stockholders' equity.............................. 42,362,000 49,626,000
----------- -----------
TOTAL............................................................. $52,529,000 $59,503,000
=========== ===========
See notes to consolidated financial statements
34
35
MINIMED INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996
YEAR ENDED
-------------------------------------------
1994 1995 1996
----------- ----------- -----------
NET SALES........................................... $36,274,000 $45,107,000 $59,080,000
COST OF SALES....................................... 16,131,000 16,531,000 20,440,000
----------- ----------- -----------
GROSS PROFIT........................................ 20,143,000 28,576,000 38,640,000
----------- ----------- -----------
OPERATING EXPENSES:
Selling, general and administrative............... 15,366,000 19,863,000 25,468,000
Research and development.......................... 5,372,000 7,095,000 7,900,000
----------- ----------- -----------
Total operating expenses.................. 20,738,000 26,958,000 33,368,000
----------- ----------- -----------
OPERATING INCOME (LOSS)............................. (595,000) 1,618,000 5,272,000
INTEREST EXPENSE.................................... (533,000) (352,000) --
OTHER INCOME, Including interest income............. 228,000 965,000 1,062,000
----------- ----------- -----------
INCOME (LOSS) BEFORE INCOME TAXES................... (900,000) 2,231,000 6,334,000
PROVISION FOR INCOME TAXES (Note 10)................ -- 422,000 1,662,000
----------- ----------- -----------
NET INCOME (LOSS)................................... $ (900,000) $ 1,809,000 $ 4,672,000
=========== =========== ===========
NET INCOME (LOSS) PER SHARE (Note 2)................ $ (0.10) $ 0.17 $ 0.38
=========== =========== ===========
WEIGHTED AVERAGE NUMBER OF COMMON AND COMMON
EQUIVALENT SHARES USED IN COMPUTING NET INCOME
(LOSS) PER SHARE (Note 2)......................... 9,085,000 10,587,000 12,238,000
=========== =========== ===========
See notes to consolidated financial statements
35
36
MINIMED INC.
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY
YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996
REDEEMABLE CONVERTIBLE
PREFERRED STOCK COMMON STOCK RETAINED
------------------------ --------------------- EARNINGS
NUMBER OF NUMBER OF (ACCUMULATED
SHARES AMOUNT SHARES AMOUNT CAPITAL DEFICIT) TOTAL
---------- ----------- ---------- -------- ----------- ----------- -----------
BALANCE,
JANUARY 1, 1994.......... 7,805,478 $ 78,000 $ 5,485,000 $(1,558,000) $ 4,005,000
Issuance of preferred stock
for technology
(Note 3)................. 200,000 --
Issuance of preferred stock
for cash, net of
expenses................. 911,111 $ 8,009,000
Repurchase of treasury
shares (Note 8).......... (75,703) (1,000) (578,000) (579,000)
Accretion of preferred
stock to redemption
value.................... 212,000 (212,000) (212,000)
Accrual of preferred stock
dividends................ 292,000 (292,000) (292,000)
Net loss................... (900,000) (900,000)
---------- ----------- ---------- -------- ----------- ---------- -----------
BALANCE,
DECEMBER 31, 1994........ 1,111,111 8,513,000 7,729,775 77,000 4,907,000 (2,962,000) 2,022,000
Accretion of preferred
stock to redemption
value.................... 219,000 (219,000) (219,000)
Accrual of preferred stock
dividends................ 292,000 (292,000) (292,000)
Issuance of common stock in
initial public offering,
net of expenses.......... 2,500,000 25,000 29,513,000 29,538,000
Conversion of redeemable
convertible preferred.... (1,111,111) (9,024,000) 1,111,111 11,000 9,013,000 9,024,000
Exercise of stock
options.................. 65,047 1,000 300,000 301,000
Tax benefit associated with
stock option exercises... 179,000 179,000
Net income................. 1,809,000 1,809,000
---------- ----------- ---------- -------- ----------- ---------- -----------
BALANCE,
DECEMBER 29, 1995........ 11,405,933 114,000 43,912,000 (1,664,000) 42,362,000
Exercise of stock
options.................. 203,020 2,000 986,000 988,000
Tax benefit associated with
stock option exercises... 994,000 994,000
Issuance of stock under
employee stock plan...... 14,822 272,000 272,000
Issuance of stock for
technology license
(Note 7)................. 10,000 285,000 285,000
Stock awards to
directors................ 2,400 53,000 53,000
Net income................. 4,672,000 4,672,000
---------- ----------- ---------- -------- ----------- ---------- -----------
BALANCE,
DECEMBER 27, 1996........ -- -- 11,636,175 $116,000 $ 46,502,00 $ 3,008,000 $ 49,626,00
========== =========== ========== ======== =========== ========== ===========
See notes to consolidated financial statements
36
37
MINIMED INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996
1994 1995 1996
----------- ----------- -----------
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss)..................................... $ (900,000) $ 1,809,000 $ 4,672,000
Adjustments to reconcile net income (loss) to net cash
provided by (used in) operating activities:
Depreciation.......................................... 760,000 1,365,000 1,914,000
Amortization of loan discount......................... 314,000 -- --
Deferred income taxes................................. -- (789,000) (1,408,000)
Changes in operating assets and liabilities:
Accounts receivable, net........................... 1,171,000 (2,795,000) (5,055,000)
Receivables due from related entities.............. 233,000 101,000 (67,000)
Inventories........................................ 2,091,000 (2,916,000) (1,560,000)
Prepaid expenses and other current assets.......... (372,000) (261,000) 23,000
Other assets....................................... -- -- (300,000)
Accounts payable................................... (1,425,000) 407,000 (253,000)
Accrued sales commissions.......................... (375,000) 59,000 954,000
Accrued salaries and related benefits.............. 406,000 335,000 713,000
Accrued warranties................................. 549,000 360,000 (370,000)
Other accrued expenses............................. (557,000) 792,000 470,000
Income taxes payable............................... -- 532,000 (69,000)
----------- ----------- -----------
Net cash provided by (used in) operating
activities....................................... 1,895,000 (1,001,000) (336,000)
----------- ----------- -----------
CASH FLOWS FROM INVESTING ACTIVITIES:
Short-term investments................................ -- (8,724,000) (793,000)
Purchase of land, buildings, property and equipment... (1,713,000) (8,700,000) (4,007,000)
----------- ----------- -----------
Net cash used in investing activities.............. (1,713,000) (17,424,000) (4,800,000)
----------- ----------- -----------
CASH FLOWS FROM FINANCING ACTIVITIES:
Repayment of note payable............................. -- (7,000,000) (600,000)
Proceeds from issuance of preferred stock, net of
expenses........................................... 8,009,000 -- --
Proceeds from initial public offering, net of
expenses........................................... -- 29,538,000 --
Proceeds from stock option exercises.................. -- 301,000 988,000
Proceeds from issuance of common stock under employee
stock plan......................................... -- -- 272,000
Repurchase of treasury shares......................... (579,000) -- --
----------- ----------- -----------
Net cash provided by financing activities.......... 7,430,000 22,839,000 660,000
----------- ----------- -----------
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS.... 7,612,000 4,414,000 (4,476,000)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD.......... 2,736,000 10,348,000 14,762,000
CASH AND CASH EQUIVALENTS, END OF PERIOD................ $10,348,000 $14,762,000 $10,286,000
=========== =========== ===========
SUPPLEMENTAL CASH FLOW INFORMATION --
Cash paid during the period for:
Interest........................................... $ 314,000 $ 361,000 --
Income taxes....................................... $ 1,000 $ 500,000 $ 1,866,000
SUPPLEMENTAL DISCLOSURE OF NONCASH FINANCING ACTIVITY -- During 1994 and
1995, the Company recorded $212,000 and $219,000, respectively in accretion of
preferred stock to redemption value and $292,000 in accrued preferred stock
dividends directly to accumulated deficit. The Company has recognized a
reduction in income taxes payable of $179,000 and $994,000 during 1995 and 1996,
respectively related to the exercise of nonqualified stock options. During 1996,
the Company issued 10,000 shares of common stock with a value of $285,000 to a
supplier in exchange for a license. The Company also issued 2,400 shares of
Common Stock with a value of $53,000 to certain Directors in lieu of fees during
1996.
See notes to consolidated financial statements
37
38
MINIMED INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996
1. GENERAL INFORMATION
Operations -- MiniMed Inc. ("MiniMed" or the "Company") designs, develops,
manufactures and markets medical devices for drug delivery and monitoring
patients with diabetes and other medical conditions. The drug delivery systems
include external and implantable microinfusion drug pumps and related disposable
products which provide long-term delivery of medication for treatment of chronic
disorders. The Company is developing glucose sensor systems which will, if
successful, provide diabetic patients with continuous monitoring of glucose
levels and may ultimately be linked to the microinfusion pumps to create an
"artificial pancreas." Other development efforts focus on developing
non-diabetes uses of the Company's technologies.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Principles of Consolidation -- The accompanying financial statements
include the accounts of the Company and its wholly owned subsidiaries MiniMed
S.A. and MiniMed GmbH. All intercompany accounts and transactions have been
eliminated. The financial statements of MiniMed S.A. and MiniMed GmbH have been
translated using the exchange rate at the end of each period as to balance sheet
items and the weighted average exchange rate during each period as to operating
results. Translation and transaction gains and losses are immaterial for all
periods presented.
Cash and Cash Equivalents -- The Company considers all highly liquid
instruments with an original maturity of three months or less to be cash
equivalents.
Short-term Investments -- In May 1993, the Financial Accounting Standards
Board ("FASB") issued Statement of Financial Accounting Standards No 115,
"Accounting for Certain Investments in Debt and Equity Securities," effective
for fiscal years beginning after December 15, 1993. The Company has classified
all of its debt securities as available-for-sale. For securities
available-for-sale, unrealized gains and losses are recorded directly to
stockholders' equity. As of December 29, 1995 and December 27, 1996, fair market
value approximates cost for the investments held. Realized gains and losses are
included in other income in the Company's statement of operations. Realized
gains and losses on short-term investments for 1995 and 1996 were not material.
The Company's investment policy is to invest idle and excess funds in high
grade, short-term, fixed income securities. The primary objective of investment
activities is to protect capital value.
Inventories -- Inventories are stated at the lower of cost or market. Cost
is determined using the first-in, first-out method.
Land, Building, Property and Equipment and Depreciation -- Land, building,
property and equipment are stated at cost. Depreciation is computed using the
straight-line method over the estimated useful lives of the related assets,
which range from two to thirty-nine years.
Research and Development -- Research and development costs are expensed as
incurred.
Net Income (Loss) per Common and Common Equivalent Share -- For the year
ended December 27, 1996, net income per common and common equivalent share is
computed based upon the weighted average number of shares of the Company's
outstanding common stock and common stock equivalents, if dilutive. For the year
ended December 29, 1995, net income per common and common equivalent share is
computed based upon the weighted average number of shares of the Company's
outstanding common stock and common stock equivalents, if dilutive, subsequent
to the completion of the Company's initial public offering in July 1995. As
required by rules promulgated by the Securities and Exchange Commission for
1994, shares, options, warrants and convertible preferred shares issued at
prices below the initial public offering price of $13.00 in the twelve months
prior to the initial public offering have been included in the calculation of
weighted average common and common equivalent shares as if outstanding using the
treasury stock method.
38
39
MINIMED INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996
Income Taxes -- Income taxes are provided for taxes currently payable or
refundable, and deferred income taxes arising from future tax consequences of
events that have been recognized in the Company's financial statements or tax
returns. The effects of income taxes are measured based on enacted tax laws and
rates. An allowance is provided for net deferred tax assets and tax loss
carryforwards for which realization is not assured.
Revenues and Concentration of Credit Risk -- During 1994, 1995 and 1996,
the Company derived approximately 84%, 84% and 86%, respectively, of its
revenues from domestic sales. Approximately 60%, 62% and 58%, respectively, of
the Company's 1994, 1995 and 1996 domestic revenues were sales to distributors
of medical products who sell the products directly to patients. The remaining
domestic revenues represent products sold by the Company directly to patients.
The Company bills these patients directly or processes billing to their health
care payors, which include indemnity insurers, HMOs, PPOs and various state
agencies. Certain distributor receivables are secured while all other
receivables are unsecured. Foreign revenues in most countries represent sales to
dealers in various countries in Europe. Sales to the European dealers may be
shipped from the United States or through the Company's subsidiaries. Certain
foreign sales are transacted directly by the Company's European subsidiaries
with patients, with reimbursement provided by the appropriate third party payors
in the appropriate country. Levels of payments from third-party payors and
patients vary, depending upon the specific benefits provided under each
patient's coverage. No single customer represents more than 10% of the Company's
sales for any period presented.
The Company has recorded an allowance for doubtful accounts to cover the
difference between recorded revenues and collections from distributors, patients
and third-party payors. The allowance and provision for bad debts are adjusted
periodically based upon the Company's evaluation of historical collection
experience, industry reimbursement trends and other relevant factors.
Stock Based Compensation -- The Company has granted stock options for a
fixed number of shares to employees with an exercise price equal to the fair
market value of the shares at the date of grant. The Company accounts for stock
option grants in accordance with APB Opinion No. 25, Accounting for Stock Issued
to Employees, and, accordingly, recognizes no compensation expense for the stock
option grants.
Pervasiveness of Estimates -- The preparation of financial statements in
conformity with generally accepted accounting principles requires management to
make estimates and assumptions that affect the reported amounts of certain
assets and liabilities and disclosure of contingent assets and liabilities at
the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. Actual results could differ from those
estimates. The Company's most significant estimates relate to the allowance for
uncollectible accounts, provisions for inventory reserves and accrued
warranties.
Fiscal Year -- In fiscal 1995, the Company adopted a 4-4-5 accounting cycle
with the fiscal year ending on the Friday closest to December 31. All prior
years presented were based on the "calendar" year ended December 31. The
Company's 1997 fiscal year end will be on January 2, 1997.
Reclassifications -- Certain reclassifications have been made to the 1994
and 1995 financial statements to conform with the 1996 presentation.
3. RELATED PARTY TRANSACTIONS
Services and Facilities Agreements -- During 1995 and 1994, the Company
provided certain support services to and shared certain facilities and equipment
with Advanced Bionics Corporation ("ABC"), a Company owned primarily by the
individual who is currently the Company's largest single stockholder, Chairman
and Chief Executive Officer. Costs charged to ABC were $470,000 and $180,000 for
the years ended December 31, 1994 and December 29, 1995. ABC owed the Company
$105,000 at December 31, 1994, $15,000 at December 29, 1995 and $90,000 at
December 27, 1996. The amount owed by ABC to the
39
40
MINIMED INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996
Company at December 27, 1996 relates to equipment sold to ABC without a material
gain or loss recognized. The Company has leased certain operating facilities to
its current Chairman and Chief Executive Officer under a one-year lease
renewable for four additional one year periods. In the event that the Chairman
and Chief Executive Officer gives the Company a notice of non-renewal, he is
obligated to pay the Company approximately $4,000 per month for improvements
made to the facility through the earlier of June 2001 or the date the Company
occupies the space. If the Company gives the Chairman and Chief Executive
Officer a notice of non-renewal, neither he nor the Company has any further
obligation. Rents charged under this agreement were $15,600 and $74,847 for the
years ended December 29, 1995 and December 27, 1996, respectively. Rental income
related to this lease is recorded in other income.
Research and Development Costs and Purchase of Technology -- During the
first six months of 1994, the Company performed research and development
services for an entity owned by its Chairman, Chief Executive Officer, and
largest single stockholder. The Company charged this affiliated entity $303,000
in 1994 for these research and development services. On June 22, 1994, the
Company issued 200,000 shares of its redeemable, convertible preferred stock to
this entity in exchange for certain technologies related to the development of a
subcutaneous glucose sensor. As the Company purchased this technology from
another entity which is considered an affiliate under rules and regulations of
the Securities and Exchange Commission, the accounting basis of the technology
transferred by the affiliate has been used to establish the value of the
technology transferred as well as the preferred stock issued by the Company. The
transferred technology had a $0 basis at the affiliate, as amounts related to
the subcutaneous glucose sensor research had been recorded as research and
development expense. Therefore, the Company assigned a $0 value to the
technology acquired, and to the preferred stock issued, for this technology.
These shares of preferred stock, along with all other outstanding shares of
preferred stock, were converted to Common Stock in conjunction with the
Company's initial public offering.
On February 18, 1997, the Company's board of directors approved a mutual
license and product improvement agreement between Medical Research Group, LLC
("MRG"), an entity controlled by the Company's Chief Executive Officer, and the
Company. The final agreement has not yet been entered into. Under the proposed
terms of this agreement, the Company will grant MRG a license to utilize certain
MiniMed technology in the development of a diabetes treatment and management
system (the "system") and will pay MRG royalties on MiniMed's sale of other
products that may utilize improvements made by MRG to the MiniMed technology.
MRG will grant MiniMed the option to purchase the marketing rights of the system
for $30.0 million at the earlier of December 31, 1998 or 90 days after MRG
achieves a pre-determined regulatory milestone in the development of the system
(subject to extensions of the option period of up to one year under certain
circumstances). In the event that MiniMed does not exercise its option to
purchase these marketing rights, MRG may, at its option, purchase products and
components from MiniMed at pre-determined transfer prices or may manufacture
these products and pay royalties to MiniMed on the use of MiniMed's technology
in the system.
40
41
MINIMED INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996
4. LAND, BUILDING, PROPERTY AND EQUIPMENT -- NET
Land, building, property and equipment, net consists of the following:
DECEMBER 29, DECEMBER 27, USEFUL LIVES
1995 1996 (YEARS)
------------ ------------ ------------
Land, buildings and improvements....... $ 6,028,000 $ 7,058,000 39 to 40
Machinery and equipment................ 4,987,000 6,682,000 3 to 5
Tooling and molds...................... 2,299,000 2,979,000 3
Furniture and fixtures................. 1,131,000 1,733,000 7
----------- -----------
14,445,000 18,452,000
Less accumulated depreciation.......... (3,892,000) (5,806,000)
----------- -----------
Total.................................. $ 10,553,000 $ 12,646,000
=========== ===========
5. OTHER ASSETS
Other assets consist of the following:
Technology license (Note 7)............... $277,000
Inventory components, non-current
(Note 7)................................ 300,000
--------
$577,000
========
6. NOTES PAYABLE AND LINE OF CREDIT
A customer advanced the Company $600,000 as part of a supply contract
without interest, payable on demand. The loan was repaid during 1996. All other
notes payable were retired with proceeds from the Company's initial public
offering in July 1995.
In January 1997, the Company entered into an unsecured line of credit
agreement which expires on January 31, 1999. Under terms of this agreement, the
Company may borrow up to $10.0 million and is required to pay monthly interest
at a rate equal to the 30-day commercial paper rate plus 2.15%. MiniMed is also
required to maintain certain cash, net worth and debt conditions under the
provisions of this agreement. The Company is currently in compliance with all of
these conditions.
7. COMMITMENTS AND CONTINGENCIES
Rental expense under operating leases to non-related parties was $143,000,
$212,000, and $0 for 1994, 1995, and 1996, respectively.
On September 11, 1996, the Company filed a lawsuit against another company
seeking rescission of a product distribution contract. Subsequent to the filing
of this action, the other company has filed a counter-claim seeking compensatory
damages of approximately $600 million and punitive damages of $300 million. The
Company believes that it has meritorious defenses to the counterclaim asserted
by Fimed. The Company intends to prosecute its claim against Fimed and defend
against the counterclaim vigorously. Discovery has commenced in the litigation,
but the matter has not yet been set for trial.
On November 1, 1996, the Company entered into a material supply and
technology license agreement with a supplier. The Company also issued 10,000
shares of common stock valued at $28.50 per share, the market value of the stock
on the date of the agreement, to this supplier in exchange for the technology
license. The Company is obligated to purchase component parts valued at
$1,125,000 during fiscal 1997. On September 30, 1997, the Company has the option
to purchase an additional $1,125,000 in components during
41
42
MINIMED INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996
fiscal 1998 or discontinue its purchasing activity with this supplier and
utilize its technology license to develop a manufacturing operation to produce
these components internally. The Company may also discontinue the utilization of
these components in all the Company's products at September 30, 1997. In
conjunction with the material supply and technology license agreement described
above, the Company purchased component parts from this supplier during fiscal
1996 which will not be used in the sale of products in fiscal 1997 based upon
planned sales levels derived from historical product demand. Accordingly, the
Company has reclassified $300,000 of these component parts as a long-term asset
included in other assets (Note 5).
During the normal course of business, the Company is subject to litigation
involving various business matters. Management believes that an adverse outcome
of any such known matters would not have a material impact to the Company.
8. REDEEMABLE, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY
Redeemable, Convertible Preferred Stock -- On June 22, 1994, the Company's
Board of Directors authorized the issuance of a series of preferred stock of the
Company, designated Series A Preferred Stock, and each share was convertible
into one share of the Company's common stock at the option of the holder of the
Series A Preferred Stock. The Company issued 1,111,111 shares of Series A
Preferred Stock in 1994. All issued and outstanding shares of Series A Preferred
Stock were automatically converted to common stock concurrent with the Company's
initial public offering in July, 1995. An additional 3,899,999 shares of
preferred stock are authorized and unissued as of December 27, 1996.
Preferences, rights, and qualifications of the unissued but authorized preferred
stock will be determined by the Board of Directors prior to the issuance of any
additional shares of preferred stock.
Treasury Stock -- On June 22, 1994, the Company's Board of Directors
approved the repurchase of 75,703 shares of common stock from its Chairman and
Chief Executive Officer for $700,000, of which $579,000 was recognized by the
Company as treasury stock and $120,000 was recognized as compensation expense.
Warrants -- In connection with the issuance of Series A Preferred Stock,
which was converted to common stock in 1995, the Company issued warrants to
purchase 200,000 shares of the Company's common stock at an exercise price of
$13.00 per share to the holders of the Series A Preferred Stock. These warrants
are exercisable at any time prior to June 22, 1997.
Stock Options and Purchase Plan -- The Company has granted stock options
under its Incentive Stock Plan ("stock option plan"), which provides that
options may have a term of up to 10 years and become
42
43
MINIMED INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996
exercisable and vest in annual increments of up to six years. An additional
524,567 options are available for grant at December 27, 1996. Stock option plan
activity is as follows:
RANGE OF OPTION
PRICES PER
SHARES SHARE
--------- ---------------
Outstanding options at January 1, 1994........... 880,850 $ 4.50 - $ 6.00
Options granted.................................. 184,250 $ 6.00 - $ 7.65
Options canceled................................. (78,550)
---------
Outstanding options at December 31, 1994......... 986,550
=========
Options granted.................................. 543,500 $ 7.65 - $12.00
Options exercised................................ (65,047) $ 4.50 - $ 7.65
Options canceled................................. (38,035)
---------
Outstanding options at December 29, 1995......... 1,426,968
=========
Options granted.................................. 303,847 $14.75 - $27.00
Options exercised................................ (203,020) $ 4.50 - $ 7.65
Options canceled................................. (71,649)
---------
Outstanding options at December 27, 1996......... 1,456,146 $ 4.50 - $27.00
=========
The following table summarizes information about stock options outstanding
at December 27, 1996:
NUMBER
OUTSTANDING WEIGHTED AVERAGE WEIGHTED WEIGHTED
RANGE OF AT DECEMBER 27, REMAINING AVERAGE SHARES EXERCISABLE AT AVERAGE
EXERCISE PRICES 1996 CONTRACTUAL LIFE EXERCISE PRICE DECEMBER 27, 1996 EXERCISE PRICE
- --------------------- ----------------- ---------------- -------------- --------------------- --------------
$4.50................ 422,546 4 $ 4.50 310,119 $ 4.50
$5.00 - $7.25........ 242,050 5 5.86 119.753 5.80
$7.65................ 490,800 6 7.65 110,100 7.65
$8.75 - $27.00....... 300,750 7 14.56 23,350 14.36
-
--------- ------ ------- ------
1,456,146 5 $ 7.81 563,322 $ 5.80
========= = ====== ======= ======
During 1996, the Company's stockholders approved an employee stock purchase
plan ("stock purchase plan"). Substantially all of the Company's employees are
eligible to participate in the stock purchase plan through regular payroll
deductions. Options under the stock purchase plan are granted for an
indeterminable number of shares on semi-annual offering dates and are
automatically exercised six months from the offering date, subject to employee
withdrawal from the stock purchase plan. Options are exercised at the lesser of:
(1) 85% of the fair market value of the common stock on the offering date
(beginning of six month period); or (2) 85% of the fair market value of the
common stock on the exercise date (end of six month period). Sale of shares
issued under the stock purchase is prohibited for one year from the exercise
date. Transactions related to the employee stock purchase plan are summarized as
follows:
WEIGHTED AVERAGE
SHARES EXERCISE PRICE
--------- ----------------
Shares available................................. 1,000,000
Exercised........................................ 14,822 $18.38
---------
Shares available at December 27, 1996............ 985,178
=========
All stock options under the stock option plan are granted at the fair
market value of the Company's common stock at the grant date. The weighted
average estimated fair value of the stock purchase plan and options granted in
1995 and 1996 was $3,854,544 and $2,089,754, respectively. The Company applies
43
44
MINIMED INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996
Accounting Principles Board Opinion No. 25 and related Interpretations in
accounting for its stock option plan and stock purchase plan. Accordingly, no
compensation cost for the Company's stock option plan and stock purchase plan
has been recognized in 1994, 1995 or 1996. Had compensation cost for the
Company's stock option plan and stock purchase plan been determined based on the
fair value at the grant dates for awards under those plans consistent with FASB
Statement No. 123, Accounting for Stock Based Compensation, the Company's net
income and earnings per share for the years ended December 29, 1995 and December
27, 1996 would have been reduced to the pro forma amounts indicated below:
YEARS ENDED
---------------------------
DECEMBER DECEMBER
29, 27,
1995 1996
----------- -----------
Net income:
As reported....................................... $ 1,809,000 $ 4,672,000
Pro forma......................................... 1,157,000 3,812,000
Net income per common and common equivalent share:
As reported....................................... $ 0.17 $ 0.38
Pro forma......................................... $ 0.11 $ 0.31
The fair value of options granted under the stock option plan during 1995
and 1996 was determined using the Black-Scholes option pricing model utilizing
the following weighted-average assumptions:
YEARS ENDED
-----------------------------
DECEMBER 29, DECEMBER 27,
1995 1996
------------ ------------
Dividend yield..................................... 0% 0%
Anticipated volatility............................. 325% 66%
Risk-free interest rate............................ 7.40% 6.09%
Expected lives..................................... 5 years 5 years
Pro forma compensation cost of options granted under the employee stock
purchase plan is measured based upon the discount from market value.
9. EMPLOYEE BENEFIT PLAN
The Company has a defined contribution plan which is available to
substantially all full-time employees of the Company. No contributions were made
during 1994. Subsequent to December 31, 1994, the Company revised the terms of
the Plan. During 1995 and future periods, the Company is obligated to contribute
a certain percentage of all employee contributions with limits specified by the
Plan. Contributions to the Plan in the years ended December 29, 1995 and
December 27, 1996 were $69,000 and $93,000, respectively.
10. INCOME TAXES
Pretax income (loss) from continuing operations for the three years in the
period ended December 27, 1996 was subject to income tax in the following
jurisdictions:
YEAR ENDED
------------------------------------------
DECEMBER 31, DECEMBER 29, DECEMBER 27,
1994 1995 1996
------------ ------------ ------------
Domestic.................................. $ (962,000) $2,208,000 $6,756,000
Foreign................................... 62,000 23,000 (422,000)
--------- ---------- ----------
Pretax income (loss)...................... $ (900,000) $2,231,000 $6,334,000
========= ========== ==========
44
45
MINIMED INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996
Significant components of the provision for income taxes are as follows:
YEAR ENDED
------------------------------------------
DECEMBER 31, DECEMBER 29, DECEMBER 27,
1994 1995 1996
------------ ------------ ------------
Current:
Federal................................. $ -- $ 812,000 $1,613,000
Foreign................................. -- -- 10,000
State................................... -- 220,000 453,000
---------- ---------- ----------
-- $1,032,000 $2,076,000
Effect of nonqualified stock option
exercises upon income taxes currently
payable:................................ -- 179,000 994,000
Deferred
Federal................................. -- (789,000) (1,100,000)
Foreign................................. -- -- --
State................................... -- -- (308,000)
---------- ---------- ----------
-- (789,000) (1,408,000)
---------- ---------- ----------
$ -- $ 422,000 $1,662,000
========== ========== ==========
The following table summarizes the changes in the Company's valuation
allowance against deferred tax assets:
YEAR ENDED
-----------------------------
DECEMBER 29, DECEMBER 27,
1995 1996
------------ ------------
Beginning balance................................ $1,629,000 $1,268,000
Change........................................... (361,000) (653,000)
---------- ----------
Ending balance................................... $1,268,000 $ 615,000
========== ==========
The components of deferred tax assets (liabilities) at December 29, 1995
and December 27, 1996 are as follows:
DECEMBER 29, 1995 DECEMBER 27, 1996
--------------------- ---------------------
FEDERAL STATE FEDERAL STATE
---------- -------- ---------- --------
Deferred tax assets:
Accrued warranties............... $1,137,000 $302,000 $1,006,000 $267,000
Accrued vacation................. 152,000 40,000 174,000 48,000
Allowance for doubtful
accounts...................... 404,000 108,000 834,000 228,000
Inventory reserve................ 614,000 163,000 792,000 225,000
Other............................ 36,000 (13,000) 128,000 21,000
---------- -------- ---------- --------
2,343,000 600,000 2,934,000 789,000
Deferred tax liabilities:
Depreciation..................... (700,000) (186,000) (633,000) (173,000)
Deferred state income taxes...... (105,000)
---------- -------- ---------- --------
Net deferred tax assets............ 1,643,000 414,000 2,196,000 616,000
Valuation allowance................ (854,000) (414,000) (307,000) (308,000)
---------- -------- ---------- --------
Total.............................. $ 789,000 $ 0 $1,889,000 $308,000
========== ======== ========== ========
45
46
MINIMED INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996
A reconciliation of the Company's provision for income taxes for 1995 and
1996 to the U.S. Federal Statutory rates is as follows:
YEAR ENDED
-----------------------------
DECEMBER 29, DECEMBER 27,
1995 1996
------------ ------------
Provision for income taxes at U.S. Statutory rates............. $716,000 $2,217,000
State taxes, net of Federal benefit............................ 134,000 94,000
Non-deductible expenses........................................ 107,000 112,000
Utilization of Federal and State operating loss
carryforwards................................................ (201,000)
Foreign loss not usable........................................ 148,000
Difference between actual rate and Federal Statutory rate...... (63,000)
Reduction of valuation allowance............................... (361,000) (653,000)
Other.......................................................... 27,000 (193,000)
-------- ----------
$422,000 $1,662,000
======== ==========
11. OPERATIONS BY GEOGRAPHIC AREA
YEAR ENDED
------------------------------------------
DECEMBER 31, DECEMBER 29, DECEMBER 27,
1994 1995 1996
------------ ------------ ------------
NET SALES
North American operations.......................... $ 33,283,000 $ 40,675,000 $ 53,569,000
European operations................................ 2,991,000 4,432,000 5,511,000
------------ ------------ ------------
Consolidated....................................... $ 36,274,000 $ 45,107,000 $ 59,080,000
========== ========== ==========
OPERATING INCOME (LOSS)
North American operations.......................... $ (617,000) $ 1,722,000 $ 5,526,000
European operations................................ 22,000 (104,000) (254,000)
------------ ------------ ------------
Consolidated....................................... $ (595,000) $ 1,618,000 $ 5,272,000
========== ========== ==========
IDENTIFIABLE ASSETS AT END OF PERIOD
North American operations.......................... $ 22,954,000 $ 50,443,000 $ 56,026,000
European operations................................ 1,556,000 2,086,000 3,477,000
------------ ------------ ------------
Consolidated....................................... $ 24,510,000 $ 52,529,000 $ 59,503,000
========== ========== ==========
46
47
ITEM 9. CHANGES WITH AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None.
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
Information with respect to Directors and Executive Officers of the Company
is incorporated by reference to the Company's definitive Proxy Statement for its
annual meeting of shareholders to be filed not later than 120 days after
December 27, 1996 with the Securities and Exchange Commission (the "1997
Proxy"). Certain information relating to Executive Officers of the Company
appears in Part I of this Form 10-K and is incorporated in Part III by this
reference.
ITEM 11. EXECUTIVE COMPENSATION
Information with respect to this item is incorporated by reference to the
Company's 1997 Proxy.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
Information with respect to this item is incorporated by reference to the
Company's 1997 Proxy.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Information with respect to this item is incorporated by reference to the
Company's 1997 Proxy.
PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENTS, SCHEDULES, AND REPORTS ON FORM 8-K
(a) 1. Financial Statements
See index to financial statements under Item 8, on page 34 for a list of
all financial statements filed as part of this report.
2. Financial statement schedules
The following financial statement schedules are filed as a part of this
Annual Report on Form 10-K:
Schedule VII -- Valuation and Qualifying Accounts
All other schedules are omitted because they are not applicable, not
required, or because the required information is included in the consolidated
financial statements or notes thereto.
3. Exhibits required to be filed by Item 601 of Regulation S-K
The following exhibits are filed as part of this Annual Report on Form 10-K
or are incorporated herein by reference:
2.1 Assignment and Assumption Agreement dated as of May 22, 1992 by
and among Alfred E. Mann, Siemens-MiniMed Inc., Siemens
Corporation, AEM MiniMed Corp., MiniMed Technologies Limited
and Pacesetter Infusion, Inc. (included as Exhibit 2.1 to the
Company's Registration Statement on Form S-1 (file no.
33-92710) which is incorporated herein by reference).
2.2 Asset Acquisition Agreement dated March 18, 1993 by and between
MiniMed Technologies Limited and MiniMed Inc. (included as
Exhibit 2.2 to the Company's Registration Statement on Form S-1
(file no. 33-92710) which is incorporated herein by reference).
47
48
3.1 Form of Restated Certificate of Incorporation of MiniMed Inc.
(included as Exhibit 3.1 to the Company's Registration
Statement on Form S-1 (file no. 33-92710) which is incorporated
herein by reference).
3.2 Bylaws of MiniMed Inc. (included as Exhibit 3.2 to the
Company's Registration Statement on Form S-1 (file no.
33-92710) which is incorporated herein by reference).
3.3 Amendment to Bylaws of MiniMed Inc. (included as Exhibit 3.3 to
the Company's 1996 Annual Report on Form 10-K which is
incorporated herein by reference).
3.4 Form of Stockholder Rights Agreement (included as Exhibit 3.4
to the Company's Registration Statement on Form S-1 (file no.
33-92710) which is incorporated herein by reference).
3.5 Certificate of Designation with respect to Series B Preferred
Stock (included as Exhibit 3.5 to the Company's Registration
Statement on Form S-1 (file no. 33-92710) which is incorporated
herein by reference.)
4.1 Specimen certificate of Common Stock (included as Exhibit 4.1
to the Company's Registration Statement on Form S-1 (file no.
33-92710) which is incorporated herein by reference).
10.1 General Principles of Cooperation dated as of December 17, 1992
by and between Novo Nordisk A/S and MiniMed Inc. (included as
Exhibit 10.9 to the Company's Registration Statement on Form
S-1 (file no. 33-92710) which is incorporated herein by
reference).
10.2 Term Sheet dated December 16, 1993 by and between Novo Nordisk
A/S and MiniMed Inc. (included as Exhibit 10.10 to the
Company's Registration Statement on Form S-1 (file no.
33-92710) which is incorporated herein by reference).
10.3 Form of Class A Stock Purchase Warrant Expiring June 21, 1997
dated June 22, 1994 by and among MiniMed Inc. and Galen
Partners II, L.P., Galen Partners International II, L.P. and
Galen Employee Fund (included as Exhibit 10.14 to the Company's
Registration Statement on Form S-1 (file no. 33-92710) which is
incorporated herein by reference).
10.4 MiniMed Technologies Limited Amended and Restated 1992 Option
Plan (included as Exhibit 10.17 to the Company's Registration
Statement on Form S-1 (file no. 33-92710) which is incorporated
herein by reference).
10.5 MiniMed Inc. 1992 Stock Incentive Plan -- Form of Option
(included as Exhibit 4.4 to the Company's Registration
Statement on Form S-8 (file no. 33-95630) which is incorporated
herein by reference).
10.6 MiniMed Inc. Option Agreement -- Assumption of MiniMed
Technologies Limited Options (included as Exhibit 10.18 to the
Company's Registration Statement on Form S-1 (file no.
33-92710) which is incorporated herein by reference).
10.7 MiniMed Inc. Second Amended and Restated 1994 Stock Incentive
Plan (included as Exhibit 10.16 to the Company's 1996 Annual
Report on Form 10-K which is incorporated herein by reference).
10.8 MiniMed Inc. 1994 Stock Incentive Plan -- Form of Option
(included as Exhibit 10.20 to the Company's Registration
Statement on Form S-1 (file no. 33-92710) which is incorporated
herein by reference).
10.9 License Agreement dated February 13, 1980, as amended December
10, 1990, by and between Applied Physics Laboratory of the
Johns Hopkins University, Pacesetter Infusion, Ltd. and MiniMed
Technologies Limited (included as Exhibit 10.24 to the
Company's Registration Statement on Form S-1 (file no.
33-92710) which is incorporated herein by
48
49
reference). (Certain redacted information in this Agreement
has received confidential treatment.)
10.10 License Agreement dated as of October 1, 1993 by and between
MiniMed Inc. and Wilson Greatbatch Ltd. (included as Exhibit
10.25 to the Company's Registration Statement on Form S-1
(file no. 33-92710) which is incorporated herein by
reference).
10.11 Supply Agreement dated as of October 1, 1993 by and between
MiniMed Inc. and Wilson Greatbatch Ltd. (included as Exhibit
10.26 to the Company's Registration Statement on Form S-1
(file no. 33-92710) which is incorporated herein by
reference).
10.12 Amendment to Supply Agreement and License Agreement dated as
of November 1, 1996 by and between MiniMed Inc. and Wilson
Greatbatch Ltd.
10.13 Form of Indemnity Agreement between MiniMed Inc. and each of
its officers and directors (included as Exhibit 10.27 to the
Company's Registration Statement on Form S-1 (file no.
33-92710) which is incorporated herein by reference).
10.14 MiniMed Inc. Non-Employee Director Deferred Stock Units Plan
(included as Exhibit 10.14 to the Company's 1996 Annual Report
on Form 10-K which is incorporated herein by reference).
10.15 MiniMed Inc. Employee Stock Purchase Plan (included as Exhibit
10.15 to the Company's 1996 Annual Report on Form 10-K which
is incorporated herein by reference).
10.16 WCMA Note and Loan Agreement dated as of January 21, 1997 by
and between MiniMed Inc. and Merrill Lynch Business Financial
Services Inc.
10.17 Lease dated as of August 1, 1995, as amended by Amendment
thereto dated as of July 1, 1996, by and between MiniMed Inc.
and Alfred E. Mann.
11.1 Statement relative to computation of per share earnings of the
Company.
21.1 Subsidiaries of the Company.
23.1 Consent of Deloitte & Touche LLP.
(b) 1. Reports on Form 8-K
None were filed during the fourth quarter of 1996.
49
50
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, as amended, MiniMed Inc. has duly caused this Report to be
signed on its behalf by the undersigned thereunto duly authorized on March 25,
1997.
MINIMED INC.
Date: March 25, 1997 By: /s/ ALFRED E. MANN
------------------------------------
Alfred E. Mann
Chairman of the Board and Chief
Executive Officer (Principal
Executive Officer)
Date: March 25, 1997 By: /s/ KEVIN R. SAYER
------------------------------------
Kevin R. Sayer
Senior Vice President, Finance
and Chief Financial Officer
(Principal Financial and Accounting
Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, this Report has been signed below by the following persons on behalf of
the Company and in the capacities indicated on March 25, 1997.
SIGNATURE TITLE DATE
- ----------------------------------------------- --------------------------- ---------------
/s/ ALFRED E. MANN Director, Chairman of the March 25, 1997
- ----------------------------------------------- Board and Chief Executive
Alfred E. Mann Officer (Principal
Executive Officer)
/s/ KEVIN R. SAYER Senior Vice President, March 25, 1997
- ----------------------------------------------- Finance and Chief Financial
Kevin R. Sayer Officer (Principal
Financial and Accounting
Officer)
/s/ DAVID CHERNOF, M.D. Director March 25, 1997
- -----------------------------------------------
David Chernof, M.D.
/s/ WILLIAM R. GRANT Director March 25, 1997
- -----------------------------------------------
William R. Grant
/s/ DAVID MACCALLUM Director March 25, 1997
- -----------------------------------------------
David MacCallum
/s/ THOMAS R. TESTMAN Director March 25, 1997
- -----------------------------------------------
Thomas R. Testman
/s/ JOHN C. VILLFORTH Director March 25, 1997
- -----------------------------------------------
John C. Villforth
50
51
MINIMED INC.
VALUATION AND QUALIFYING ACCOUNTS -- SCHEDULE VII
COLUMN A -- COLUMN B -- COLUMN C -- ADDITIONS COLUMN D-- COLUMN E--
---------------------------------
BALANCE AT (1) CHARGED TO (2) BALANCE
BEGINNING CHARGED TO COSTS OTHER AT END
DESCRIPTION OF PERIOD AND EXPENSES ACCOUNTS DEDUCTIONS OF PERIOD
- --------------------------------- ----------- ---------------- -------------- ---------- ----------
Allowance for doubtful accounts:
1994........................ 1,149,000 1,168,000 (961,000) 1,356,000
1995........................ 1,356,000 391,000 (420,000) 1,327,000
1996........................ 1,327,000 1,750,000 (502,000) 2,575,000
Accrued warranties:
1994........................ 2,334,000 549,000 2,883,000
1995........................ 2,883,000 360,000 3,243,000
1996........................ 3,243,000 (370,000) 2,873,000
- ---------------
(1) The allowance for doubtful accounts represents charges to bad debt expense
for the year.
(2) The allowance for doubtful accounts represents reductions of revenues for
pricing adjustments, return estimates and bad debts. The accrued warranties
reductions represent present lower warranty rates experienced in 1996.
51