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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10 - K
X ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
---- SECURITIES AND EXCHANGE ACT OF 1934
For fiscal year ended March 31, 1996
OR
---- TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Commission File Number: 0-10961
QUIDEL CORPORATION
(Exact name of Registrant as specified in its charter)
DELAWARE 94-2573850
(State or other jurisdiction (I.R.S. Employer
or incorporation or organization) Identification No.)
10165 McKellar Court, San Diego, 92121
California (zip code)
(Address of principal executive
offices)
Registrant's telephone number, including area code (619) 552-1100
Securities registered pursuant to Section 12(b) of the Act: NONE
Securities registered pursuant to Section 12(g) of the Act: Common Stock,
$0.001 par value
Indicate by check mark whether the Registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
Registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes X No
--- ---
Indicate by check mark if disclosure of delinquent filers pursuant to
Item 405 of Regulation S-K is not contained herein, and will not be contained,
to the best of Registrant's knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K or any
amendment to this Form 10-K. [ ]
The aggregate market value of the voting stock held by nonaffiliates of
the Registrant as of June 7, 1996 was approximately $81,540,000. For the
purposes of this calculation, shares owned by officers, directors and 5%
stockholders known to the Registrant have been deemed to be owned by affiliates.
The number of shares outstanding of the Registrant's Common Stock as of
June 7, 1996 was 21,579,347.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of Registrant's Proxy Statement for the Annual Meeting of Stockholders
scheduled to be held on July 30, 1996 (the "Proxy Statement"), which will be
filed with the Securities and Exchange Commission no later than 120 days after
the close of the Registrant's fiscal year ended March 31, 1996 ("fiscal 1996"),
are incorporated herein as provided in Part III, and portions of the
Registrant's Annual Report to Stockholders for fiscal 1996 (the "1996 Annual
Report"), are incorporated herein as provided in Parts I, II and IV.
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PART I
ITEM 1. BUSINESS
Quidel Corporation discovers, develops, manufactures and
markets rapid immunodiagnostic products for point-of-care detection of human
medical conditions and illnesses. These products provide simple, accurate and
cost-effective diagnoses for acute and chronic conditions in the areas of
reproductive and women's health, infectious diseases, allergies and autoimmune
disorders. Quidel's products are sold to professionals in the physician's
office, and clinical laboratory, and to consumers through retail drug stores.
When used in this Report, "Quidel," the "Company" and the "Registrant" refer to
Quidel Corporation.
Quidel commenced its operations in 1979 and launched its first
products, dipstick-based pregnancy tests, in 1984. The Company has expanded its
product base through internal development and acquisition in the areas of
pregnancy and ovulation, infectious disease, allergy and autoimmune products for
professional and home use. Quidel markets its products in the United States and
in nearly 60 other countries worldwide through a broad network of national and
regional distributors, supported by the Company's direct sales force.
In January 1995, the Company purchased Pacific Biotech, Inc.,
a California corporation ("PBI"), from Eli Lilly and Company. PBI provides a
complementary line of rapid diagnostic tests for pregnancy, strep throat and
mononucleosis. The products are sold under the CARDS(R) O.S.(R), CARDS(R) QS(R),
Concise(R) Plus(TM) and Concise(R) Performance Plus(TM) brand names on a
worldwide basis.
The Company's executive offices are located at 10165 McKellar
Court, San Diego, California 92121 and its telephone number is (619) 552-1100.
INDUSTRY OVERVIEW
Diagnostic tests provide medically important information for
the assessment and management of human health. Immunoassays are diagnostic tests
which utilize biological compounds called antibodies to aid in the detection and
measurement of substances such as antibodies, hormones, bacteria and other
infectious agents from samples derived from blood, urine and other body fluids.
Unlike some other major segments of the diagnostic testing market, immunoassays
lend themselves readily to rapid testing formats, which generally provide test
results in minutes without the need for laboratory instrumentation to perform
and "read or interpret" the test result. The speed and convenience of
immunoassays, in combination with their specificity and sensitivity to
substances which may be present only in minute concentrations, have made them a
tool for the early detection, screening and monitoring of a wide range of
medical conditions.
The rapid testing market has grown recently, with the
following as contributing factors:
- Technological Advances. Historically, the use of
immunoassays was limited primarily to physicians and
laboratory professionals who possessed specialized
training or equipment. Recent advances in
immunochemistry and delivery-system technology have
expanded the range of available tests and made
immunoassays faster, more accurate and easier to use
and interpret. These advances have led to increased
use of immunoassays by physicians and laboratory
professionals and to the introduction of immunoassays
into the over- the-counter market for consumer use in
pregnancy and ovulation testing.
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- Emphasis on Health Care Cost Control. Health care
professionals, government and commercial third-party
payors are placing increasing emphasis on diagnostic
testing as a cost-effective means of early disease
detection. Prompt and accurate testing through
immunoassays may allow therapeutic intervention to be
initiated earlier in the disease process and may
eliminate unnecessary therapy, thus generating
significant cost savings. For example, the use of
immunoassays to distinguish between an allergy and an
upper respiratory infection can lead to immediate
commencement of appropriate therapy rather than more
prolonged and costly approaches that might otherwise
be followed until an accurate diagnosis is made.
- Introduction of New Therapies. Advanced forms of
therapy often require highly specific, real-time
diagnostic information. For example, many infertility
procedures require precise information about the
timing of ovulation. Immunoassays, both as early and
precise indicators of medical conditions and as
monitors of disease progression, aid in improved
patient management and prognosis through more
appropriate and timely use of available and emerging
therapeutic procedures and products.
BUSINESS STRATEGY
The Company's goal is to continue to expand its position as a
worldwide provider of rapid diagnostics for the physician's office, hospital,
clinical laboratory, and home testing markets. Key elements of the Company's
business strategy include:
- Focus on Rapid Diagnostics. The Company has dedicated
its research, manufacturing and marketing resources
to rapid diagnostics and has a well-established
record of developing and bringing to market
innovative products. The Company believes that it is
well positioned to capitalize on the anticipated
growth in the market for low cost, reliable and rapid
diagnostic products. As the move to managed care
increases, the utilization of rapid testing at the
point of care is expected to increase.
- Build on Core Technology. The Company's technology is
based on an innovative blend of biotechnology,
immunochemistry and engineering which has produced a
number of rapid and reliable assays in easy-to- use
test formats. The Company has successfully applied
this technology to the three important phases of
immunoassay product development - generation and
purification of biological reagents, design of
innovative delivery systems and implementation of
manufacturing and engineering systems necessary for
high quality, cost-effective production. The Company
continues to target its new product opportunities in
areas where its core technology and expertise offer
significant competitive advantages.
- Continue to Broaden Product Line. The Company's
strategy is to produce a broad product line of
diagnostic tests which address significant commercial
markets. The Company's growth to date has been
achieved through a combination of internal product
development, collaborative development arrangements
with strategic partners and acquisitions. The Company
believes that a broad product portfolio enhances both
Quidel's reputation in the diagnostic marketplace and
the efficiency of its manufacturing and sales and
marketing organizations. The Company's product
strategy involves increasing emphasis on internally
developed products.
- Utilize Multiple Distribution Channels. The Company
employs multiple distribution channels to address the
unique requirements of the physician's office,
hospital, clinical laboratory, and consumer over-
the-counter and international markets. In the
physician's office, hospital and clinical laboratory
markets, the Company utilizes a
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network of leading medical/surgical product
distributors supported by its direct sales force. In
the consumer over-the-counter market, the Company has
entered into an agreement with Ansell Consumer
Products to perform the sales and marketing of Quidel
branded products. In the international market, the
Company has established a broad network of
distributors who market the Company's products and,
through the use of four European subsidiaries, has
expanded its presence worldwide. The Company is
increasing its emphasis on marketing of its
diagnostic products under Quidel brand names to the
consumer, physicians and clinical laboratories.
TECHNOLOGY
Immunoassays utilize commercially produced protein molecules
called antibodies which react with or bind to specific antigens, such as other
antibodies, viruses, bacteria, hormones and drugs. The antibodies produced in
response to a particular antigen bind specifically to that antigen. This
characteristic allows antibodies to be used in a wide range of diagnostic
applications.
The ability to detect the binding of antibodies to target
antigens forms the basis for immunoassay testing. In immunoassays, antibodies
or, in the case of allergy testing, allergens (allergy-causing substances), are
typically deposited onto a solid substrate. A chemical label is then either
incorporated onto the solid substrate or added separately once the solid
substrate has been exposed to the test sample. If the target antigen is present
in the test sample, the chemical label produces a visually identifiable color
change in response to the resulting antibody or allergen reaction with the
antigen. This provides a clear color endpoint for easy visual verification of
the test results.
Quidel incorporates antibody technology and biochemistry into
uniquely designed and engineered products. Quidel has developed four primary
delivery system formats: dipsticks, flow-through cassettes, microwell tests and
a new delivery system technology based on a proprietary one-step lateral flow
technique. Although each is based on the same general antibody-antigen based
approach, the four formats differ in terms of speed, ease-of-use and
sensitivity, and, as a result, address the particular needs of different
end-user markets.
PRODUCT LIFE CYCLES
The Company's results can be significantly affected by the
phase-out of older products near the end of their product life cycles, as well
as the timing and success of new product introductions. A successful new product
launch can result in strong initial sales as inventories are built up during the
pipeline fill period, followed by a decline in sales before reaching normalized
levels. The ability of the Company to compete successfully in the rapid
diagnostics market depends on the continual development and introduction of new
products. There can be no assurance that the Company will be able to develop
sufficient new product entries to replace older products in a timely manner, or
that its new products will gain significant market acceptance.
VARIABILITY IN DEMAND
Sales levels for several of the Company's products are
affected by seasonal demand trends. Allergy tests, for example, are most heavily
used in the spring and thus have the greatest revenue impact in the fourth
fiscal quarter. Group A strep tests, by contrast, are used primarily in the
winter and tend to benefit the third and fourth fiscal quarters. As a result of
these demand trends, the Company generally may achieve lower results in the
first and second quarters and higher results in the third and fourth quarters of
the fiscal year.
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MARKETING THROUGH STRATEGIC PARTNERS
Prior to fiscal 1994, approximately half of the Company's net
sales had been to Becton Dickinson and Company ("Becton Dickinson") under
arrangements which gave Quidel manufacturing rights and Becton Dickinson
marketing rights to certain products developed by Quidel or jointly developed by
Quidel and Becton Dickinson. The Company's current strategy, however, is to
reduce its dependence on a single strategic partner. Accordingly, sales to
Becton Dickinson decreased to approximately 30% of total net sales in fiscal
1994, approximately 7% of total net sales in fiscal 1995, and approximately 1%
of total net sales in fiscal 1996. The Company's partnering strategy moving
forward is to pursue agreements to develop products under the Quidel brand names
in several areas, including human disease management, collaborations with
pharmaceutical development companies, and non-human areas such as veterinary
medicine.
WOMEN'S REPRODUCTIVE HEALTH
According to a United States Department of Health and Human
Services 1990 estimate, 5 million couples in the United States are affected by
infertility. In addition, the Company believes that a growing number of couples
desire to control the timing of their pregnancies. For conception to occur, it
is necessary for the sperm and the egg to unite during the 12-24 hour period
following ovulation. Tests that predict or confirm the occurrence of ovulation
are important tools, both for the fertility specialist and for the consumer, for
increasing the likelihood of or planning the timing of conception.
In 1984, Quidel introduced OvuKit(R), the first rapid
ovulation prediction product. This product enables women to accurately detect in
a urine sample the sharp increase in luteinizing hormone (LH), which triggers
ovulation. Since the introduction of OvuKit(R), Quidel has continued to expand
its presence in the ovulation market through a broadened line of products
incorporating faster, easier-to-use delivery systems.
- OvuKit(R) Self-Test and OvuQuick(R) Self-Test.
Quidel's ovulation prediction tests each detect
urinary LH and are differentiated according to the
delivery system they employ and the end-user markets
they address. OvuKit Self-Test uses the Company's
proprietary dipstick technology and is marketed by
Quidel to physicians who dispense it to their
patients for home use. OvuQuick Self-Test is a four
minute proprietary technology that is marketed by
Quidel to pharmacies and physicians who in turn
dispense it to their patients.
- Conceive(R) One-Step Ovulation Predictor,
Q-Test(R) Ovulation Test, and OvuQuick(R) One-Step.
The Company introduced Conceive(R) during the fourth
quarter of fiscal 1992. The product represents the
first of a line of new generation rapid one-step
tests and allows the user, in three minutes, to
predict ovulation. Conceive(R) is sold to the
consumer over-the-counter market and is designed for
the family who is planning for conception rather than
for couples with infertility problems. Pursuant to an
agreement in mid-1995, Quidel obtained marketing
rights to Q-Test(R) Ovulation Test and reintroduced
the product in its latest one-step technology. During
fiscal 1996, the Company introduced
OvuQuick(R) One-Step employing this same rapid, one-
step technology.
Sales of the Company's ovulation products for the years ended
March 31, 1996, 1995 and 1994 accounted for approximately 18%, 19% and 28%,
respectively, of total net sales.
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PREGNANCY PRODUCTS
The worldwide pregnancy test market is one of the largest
rapid testing market segments. The early detection of pregnancy allows the
physician and patient to institute proper prenatal care, helping to ensure the
health of the developing embryo and the mother. In 1984, Quidel introduced its
first products for the early detection of pregnancy. These dipstick-based
products detect minute amounts of human Chorionic Gonadotropin ("hCG"), a
hormone which is present in the urine of pregnant women very early in the
gestation period. Since 1984, Quidel has continued to improve its delivery
system technology, resulting in faster, easier-to-use pregnancy detection
products.
- Q-Test(R) Pregnancy Test. Quidel's pregnancy
prediction tests each detect urinary hCG and are
differentiated according to the delivery system they
employ and the end-user markets they address.
Q-Test(R) Pregnancy Test originally used the
Company's patented dipstick chemistry and was sold in
the consumer over-the-counter market by Becton
Dickinson pursuant to a distribution agreement with
Quidel. In the second half of fiscal 1995 marketing
rights were transferred to Quidel, and the Company
updated the product with its latest one- step
technology.
- Conceive(R) One-Step Pregnancy Test, QuickVue(R)
One-Step Pregnancy Test, QuickVue(R) One-Step
Urine-Serum Combo Test and RapidVue(R) One-Step
Pregnancy Test. As a complement to the Company's
Conceive(R) line of family planning products, the
Company introduced the Conceive(R) One- Step
Pregnancy Test in fiscal 1993 and the RapidVue(R)
One-Step Pregnancy Test in fiscal 1994. Both tests
utilize lateral flow technology, provide results in
as fast as one minute and address two different
segments of the over-the-counter market. QuickVue(R)
One-Step Pregnancy Test is the professional pregnancy
product and the QuickVue(R) One-Step Urine-Serum
Combo test provides doctors' offices and hospitals
with the convenience of using either a urine or serum
sample for their pregnancy determinations. During
fiscal 1994, the Company began distribution of its
Conceive(R) One-Step products in Europe under the
existing French tradenames of Blue Test(R) Confidence
Pregnancy Test (Europe) and BlueCard(R) pregnancy
Test (France). During fiscal 1996, the Company
launched a new brand in Spain under the SupraPlus(R)
trademark.
- CARDS(R) QS(R) HCG-Urine and Concise(R) Performance
Plus(TM) HCG-Urine. The PBI one-step pregnancy test
has strong trademark recognition globally in
professional markets and in selected over-the-counter
markets. The tests' plus and minus sign endpoints
provide easy results interpretation which have
universal appeal.
Sales of the Company's pregnancy products for the years ended
March 31, 1996, 1995 and 1994 accounted for approximately 49%, 44% and 24%,
respectively, of total net sales.
INFECTIOUS DISEASE PRODUCTS
Infectious diseases are the cause of a wide range of often
debilitating and potentially fatal health care problems. The Company
manufactures and markets a variety of products designed to detect several common
infectious diseases. These tests detect the specific infectious agent, generally
bacterial or viral in nature, or antibodies generated in response to the
infection. The Company's products are targeted to the professional market where
the early detection of infectious diseases through rapid diagnostics can provide
opportunities for more effective and efficient therapeutic intervention.
- Quidel QuickVue(R) In-Line One-Step Strep A Test.
Each year millions of people in the United States are
tested for Group A streptococcal infections, commonly
referred to as strep throat. Group A streptococci are
organisms that typically cause illnesses such as
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tonsillitis, pharyngitis and scarlet fever which, if
left untreated, can progress to complications such as
rheumatic fever. During fiscal 1995, the Company
introduced a unique one-step test which utilizes an
in-line extraction procedure from a throat swab
specimen. This test differentiates itself from all
other strep tests which require as many as five or
six separate and sometimes time-dependent steps. In
March 1996, this test received CDC-CLIA Waived
classification status which potentially expands the
market available for this product.
- Q-Test(R) Strep. This product was developed under a
research and development agreement with Becton
Dickinson and is sold to the physician's office
market worldwide exclusively by Becton Dickinson. The
manufacturing rights to the Q-Test(R) Strep product
were transferred to Becton Dickinson during fiscal
1995; as such there were no sales of the product in
fiscal 1996. As a percent of the Company's total
sales, the product declined to 3% in fiscal 1995,
from 24% and 35% in fiscal 1994 and 1993,
respectively.
- CARDS(R) QS(R) Strep A and Concise(R) Performance
Plus(TM) Strep A. The PBI brands of Strep A tests are
notable for their easy to read plus and minus sign
endpoints. The simple procedure is ideally suited for
large volume testing sites such as reference
laboratories and HMOs. These products were under
development during fiscal 1996 as the Company
converted PBI's technology to its own for improved
operational efficiencies. Both products were under
FDA review for market clearance during fiscal 1996.
- Quidel QuickVue(R H. Pylori Test. In February 1994, a
meeting convened by the National Institutes of Health
confirmed Helicobacter pylori (H. pylori) as a major
cause of ulcers and chronic gastritis. The Quidel
QuickVue(R) H. Pylori Test kit was the first rapid
test developed and then cleared by the U.S. Food and
Drug Administration ("FDA") for the physician's
office market. The test uses a few drops of serum or
plasma and provides results in as few as four
minutes. During fiscal 1996, the Company's
QuickVue(R) One Step H. Pylori Test was cleared for
sale by the FDA. This product employs the Company's
Generation III, one-step technology and can also use
finger stick whole blood samples which are very
convenient for the physician.
- Quidel QuickVue(R) Group B Strep. Group B
streptococcal infection is a vaginal infection that,
when transferred to a newborn during birth,
frequently results in significant physical handicaps,
mental retardation or death for the infected baby.
The Quidel Group B Strep product is one of the first
rapid screening tests using a vaginal swab that
allows detection of Group B strep. This test is
suitable for use both in routine screening and in the
labor and delivery setting.
- CARDS(R) O.S.(R) Mono and Concise(R) Plus(TM) Mono.
Infectious mononucleosis ("IM") is a self-limiting
disease in adolescence which often has symptomology
mimicking other potentially serious disease states.
Screening for IM is an important step to insure
proper patient follow-up. The PBI mononucleosis test
was the first to utilize a simple whole blood patient
sample. The plus and minus sign endpoints are easy to
interpret and make this test easy to use in the
physician's office.
- QuickVue(R) Chlamydia Test. The Chlamydia trachomatis
organism is responsible for the most widespread
sexually transmitted disease in the United States.
Over one-half of infected women do not have symptoms
and if left untreated, Chlamydia can cause pelvic
inflammatory disease and is a leading cause of
involuntary sterility. The test utilizes the
Company's lateral flow technology, it is fast and
easy to use in the doctor's office or clinical
laboratory.
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Total sales of the Company's infectious disease products for
the years ended March 31, 1996, 1995 and 1994 accounted for approximately 17%,
18%, and 29%, respectively, of total net sales.
ALLERGY PRODUCTS
It is currently estimated that over 40 million people in the
United States suffer from one or more significant allergies. Differentiating the
allergic rhinitis patient from one with viral or bacterial upper respiratory
distress is an important step in prescribing the appropriate patient treatment.
The recent introduction of non-sedating antihistamine drugs for the treatment of
various allergic conditions has increased the importance of accurate allergy
diagnosis. Historically, the basic tool for allergy testing has been skin
testing, a procedure which requires the injection or scratching of the skin with
a tiny amount of allergen followed by an evaluation of the inflamed zone.
Technological advances at Quidel have made in vitro tests available in a format
which requires no specialized equipment, is easy to use and can be readily
performed in the primary care physician's office.
- Quidel Allergen Screen. This test, which uses the
Company's multi- analyte dipstick technology, detects
certain allergen-specific antibodies, called IgE
antibodies, in serum or whole blood. The Company
currently markets five panels for allergens common to
specific regions of the United States, seven panels
for Europe and five panels for Japan and Asia. The
product is sold by Quidel to physicians for in-office
use.
- Quidel Total IgE. This test, which uses the Company's
proprietary dipstick technology, detects total IgE
antibodies in serum or whole blood. The test is
designed as a preliminary screen of potentially
allergic patients and is used in conjunction with the
Quidel Allergen Screen products. The product is sold
by Quidel to physicians for in- office use.
- Quidel Food Allergen Screen. This product, which uses
the Company's multi-analyte dipstick technology,
detects IgE antibodies in serum or whole blood. The
Company currently markets a United States and a
European food panel. The product is sold by Quidel to
physicians for in-office use.
- Quidel Reflectance Analyzer ("QRA"). The QRA,
developed in conjunction with an outside vendor, is
an instrument designed to provide quantitative
results for the Quidel allergy line. The product is
primarily sold in foreign markets through
distributors.
- QuickVue(R) One-Step Allergen Screen. This one-step
test screens for five common indoor allergens. It is
designed for use by primary care physicians to
differentiate allergy symptoms such as rhinitis and
wheezing from viral or bacterial upper respiratory
infections such as cold and flu. The test utilizes a
small blood sample obtained from a finger stick and
provides results in 15 minutes or less.
Total sales of the Company's allergy products for the years
ended March 31, 1996, 1995 and 1994 accounted for approximately 8%, 8%, and 12%,
respectively, of total net sales.
AUTOIMMUNE PRODUCTS
Autoimmune disorders, such as rheumatoid arthritis and
systemic lupus erythematosus, are among the most complex major medical problems
not yet conquered by medical science. Diagnostic testing in this area is an
emerging field. Much of the current knowledge about
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diagnosis and monitoring of these diseases has been discovered within the last
decade and is based on the fact that circulating immune complexes ("CICs")
appear to act as accurate markers for autoimmune disorders. The current market
for autoimmune diagnostic products is in the clinical laboratory. Quidel
believes that, as this testing market develops and moves toward more rapid,
non-instrumented testing procedures, the market for diagnostic testing for
autoimmune disorders will increase, particularly in the physician's office
segment.
Quidel's Immune Complex Products include tests for the
measurement of CICs and antibodies directed against the body's own healthy
cells, and other tests which measure the activation of other components of the
immune response system. These tests may enhance the ability to diagnose disease
onset, to monitor disease progression, to evaluate organ damage and to assess
the effects of therapy. In addition, Quidel offers a line of monoclonal and
polyclonal antibodies, purified complement proteins and other specialized
reagents sold primarily to research scientists.
RESEARCH AND PRODUCTS UNDER DEVELOPMENT
In the development of new products, the Company seeks to
maximize product reliability, speed, shelf-life and ease-of-use, while ensuring
cost-effective manufacturing through automation and engineering design. Quidel
is currently developing several new products in a delivery system format based
on a proprietary one-step lateral flow technology, which the Company believes
will provide faster results and be more convenient to use than previous test
formats. Quidel's future products include: a male Chlamydia test, additional
one-step allergy screens (an outdoor panel and a food panel), and a QuickVue(R)
Fecal Hemoglobin Test, which measures non-obvious blood in the feces for the
identification of patients at risk for colorectal cancer. Quidel believes that
it has made significant progress in the development of its new products;
however, all such products are still subject to substantial uncertainty
regarding completion of development, clinical trials and regulatory clearance.
There can be no assurance of the successful development or marketing of new
products.
For the fiscal years ended March 31, 1996, 1995 and 1994, the
Company incurred $4,130,000, $3,728,000, and $3,830,000, respectively, for
research and development, including costs incurred under research contracts.
RESEARCH AND DEVELOPMENT COLLABORATIONS
Since its inception, the Company has entered into research and
development collaborations with other companies in order to increase the pace of
its new product introductions. The Company's research and development agreements
have, in the past, generally provided that the research and development partner
fund a portion of the research and development cost of a new product in exchange
for exclusive marketing rights to such product in a specific geographic region
once the product is introduced. Such partner also agrees to enter into a supply
agreement with Quidel when the new product is introduced, pursuant to which
Quidel agrees to manufacture and such partner agrees to purchase from Quidel
certain minimum quantities of the product to be sold by such partner.
The Company's new research and development collaboration
strategy emphasizes human disease management. This strategy pairs the Company's
development efforts with the drug development efforts of pharmaceutical
companies. The goal of such collaborations is to have available a differential
diagnostic rapid test at the time of market introduction of the therapeutic
product. By diagnostically identifying the patients most likely to benefit from
new therapies, it is believed that costs related to inappropriate therapy
delivered to "negative" patients can be avoided, while increasing the efficacy
of therapy among those patients most in need.
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During fiscal 1996, the Company signed a Heads of Terms
agreement with Glaxo Group Ltd., a wholly-owned subsidiary of Glaxo Wellcome, to
develop an influenza A and B diagnostic test to be used in conjunction with
their new drug to treat influenza, presently in phase II clinical trials
worldwide.
MARKETING AND DISTRIBUTION
The Company markets its products through a network of domestic
and international distributors, European subsidiaries and to a lesser extent
strategic partners, all of which are directed at three primary market segments:
physician's office, hospitals and clinical laboratories, and consumer
over-the-counter.
- U.S. Physician's Office. Quidel utilizes various
national and regional distributors to service the
physician's office market, supporting these
distributors' efforts with the Company's own sales
force. The Company believes that this approach
affords it greater control over product marketing
with a greater ability to introduce product
innovations in response to market demands. The
Company supports and promotes its products to this
market segment through direct mailings of product
information, trade journal advertising, sales calls,
press releases and presentations at professional
conferences.
- U.S. Hospitals and Clinical Laboratories. Quidel
serves a select group of hospitals and clinical
laboratories through its national distributors,
supported by sales specialists.
- U.S. Consumer Over-the-Counter. During the past three
years, with the introduction of its
Conceive(R) Ovulation Predictor and Conceive(R)
Pregnancy Test, the Company has increased its
presence in the consumer market with Quidel branded
products. These products were sold to chain and
independent drug stores through a network of brokers,
wholesalers and directly by the Company. The Company
recently entered into an agreement with Ansell
Consumer Products, under which Ansell will assume the
sales and marketing of the Quidel brands.
- International. Quidel markets its products to these
same three market segments in over 60 countries. The
Company's primary international territories include
Korea, Japan, Germany and other Western European
countries. In some cases, Quidel ships its products
unpackaged to its international distributors, who
perform final packaging of the products to meet local
market requirements. This provides the Company with
quick access to multiple international markets
without the costs, regulatory issues and inventory
investment associated with international packaging.
In order to increase sales and marketing focus within
the European markets, the Company has acquired or
established sales subsidiaries in France, Germany,
The Netherlands and Spain.
In the fiscal years ended March 31, 1996, 1995 and 1994,
export sales, which are denominated in United States dollars and represent
export sales from the United States to third parties, were $9,051,000,
$6,562,000, and $4,919,000, respectively. Total international sales, including
both export sales from the United States to third parties and third party sales
by Quidel's European subsidiaries, represented approximately 39%, 34%, and 25%
of total net sales for the fiscal years ended March 31, 1996, 1995 and 1994,
respectively. For additional information concerning export sales by geographic
region, see Note 4 of Notes to Consolidated Financial Statements included on
page 19 of the Company's 1996 Annual Report incorporated herein by reference.
The Company generally ships products to its customers within
15 days of receipt of purchase orders. Shipments to international distributors
are made under purchase orders received from 30 to 90 days in advance of
shipment. Because the amounts ordered and the lead
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times specified vary widely from order to order and period to period, the
Company does not consider backlog to be a meaningful indicator of future
revenues.
MANUFACTURING
Quidel's manufacturing facilities, located in San Diego,
California, consist of laboratories devoted to tissue culture and
immunochemistry, and production areas dedicated to packaging and filling. In the
manufacturing process, the Company uses biological, chemical and packaging
supplies and equipment which are generally available from several competing
suppliers.
The Company believes that its manufacturing is conducted in
compliance with the "Good Manufacturing Practices" ("GMP") regulations of the
FDA governing the manufacture of medical devices. Quidel has registered its
facility with the FDA and with the Department of Health Services of the State of
California and has passed routine federal and state inspections confirming the
Company's compliance with the GMP regulatory requirements for in vitro
diagnostic products.
The manufacture of medical diagnostic products is difficult,
particularly with respect to the stability and consistency of complex biological
components. Because of these complexities, manufacturing difficulties
occasionally occur that delay the introduction of products, result in excess
manufacturing costs or require the replacement of products already introduced
into the distribution channel.
GOVERNMENT REGULATION
The manufacture and marketing of medical devices, including in
vitro diagnostic test kits, are regulated under the 1976 Medical Device
Amendments to the Federal Food, Drug and Cosmetic Act and its amended and/or new
provisions under the Safe Medical Act of 1990. These regulations are
administered by the FDA. While these regulations are demanding, they are
considerably less burdensome than those applicable to the manufacture and
marketing of drugs or monoclonal antibodies for in vivo applications. In
addition to the foregoing, the Company's present and future operations or
products may be subject to regulation under the Occupational Safety and Health
Act, Environmental Protection Act, Resource Conversion and Recovery Act, Toxic
Substances Control Act, Clinical Laboratory Improvement Act and other present or
possible future legislation and regulations, as well as by governmental agencies
with regulatory authority relating to the Company's business.
PATENTS AND TRADE SECRETS
Because of the length of time and the expense associated with
bringing healthcare products through development and government approval to the
marketplace, the healthcare industry has traditionally placed considerable
importance on obtaining and maintaining patent and trade secret protection for
significant new technologies, products and processes. Quidel and other companies
engaged in research and development of new diagnostic products using advanced
biomedical technologies are actively pursuing patents for their technologies
which they consider novel and patentable. However, important legal issues remain
to be resolved as to the extent and scope of available patent protection in the
United States and in other important markets worldwide. The resolution of these
issues and their effect upon the long-term success of Quidel and other
biotechnology firms cannot be determined.
It has been Quidel's policy to file for patent protection in
the United States and other countries with significant markets, such as Western
European countries and Japan, if the economics are deemed to justify such filing
and Quidel's patent counsel determines that a strong
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patent position can be obtained. Quidel currently has been issued and/or
licensed twenty-three United States patents with potential applications for
diagnostic products and has additional United States patent applications on file
covering technology with potential diagnostic uses. No assurance can be given
that patents will be issued to Quidel pursuant to its patent applications in the
United States and abroad or that Quidel's patent portfolio will provide Quidel
with a meaningful level of commercial protection.
A large number of individuals and commercial enterprises seek
patent protection for technologies, products and processes in fields related to
Quidel's areas of product development. To the extent such efforts are
successful, Quidel may be required to obtain licenses in order to exploit
certain of its product strategies. There can be no assurance that such licenses
will be available to Quidel at all, or if so, on acceptable terms.
Quidel is aware of certain issued and filed patents, issued to
various developers of diagnostic products with potential applicability to
Quidel's diagnostic technology. The Company has licensed certain rights from
companies such as Syntex and Becton Dickinson. There can be no assurance that
Quidel would prevail if a patent infringement claim were to be asserted against
Quidel.
Quidel seeks to protect its trade secrets and nonproprietary
technology by entering into confidentiality agreements with employees and third
parties (such as potential licensees, customers, joint ventures and
consultants). In addition, Quidel has taken certain security measures in its
laboratories and offices. Despite such efforts, no assurance can be given that
the confidentiality of Quidel's proprietary information can be maintained. Also,
to the extent that consultants or contracting parties apply technical or
scientific information independently developed by them to Quidel projects,
disputes may arise as to the proprietary rights to such data.
Under certain of its distribution agreements, Quidel has
agreed to indemnify the distributor against costs and liabilities arising out of
any patent infringement claim by a third party relating to products sold under
those agreements. In some cases, the distributor has agreed to share the costs
of defending such a claim and will be reimbursed for the amount of its
contribution if the infringement claim is found to be valid.
COMPETITION
The Company believes that the competitive factors in the rapid
diagnostic market include convenience, price and product performance as well as
the distribution, advertising, promotion and brand name recognition of the
marketer. Competition in the development and marketing of diagnostic products is
intense and diagnostic technologies have been subject to rapid change.
Management believes that Quidel's success will depend on its ability to remain
abreast of technological advances, to introduce technologically advanced
products, and to attract and retain experienced technical personnel, who are in
great demand. Many of the Company's current and prospective competitors,
including several large pharmaceutical and diversified health care companies,
have substantially greater financial, marketing and other resources than Quidel.
There can be no assurance that technological advances by competitors will not
render the Company's products obsolete, or that it will be able to compete
successfully in the marketing of products.
HUMAN RESOURCES
As of March 31, 1996, the Company had 263 employees, none of
whom is represented by a labor union. The Company has experienced no work
stoppages and believes that its employee relations are good.
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Item 2. PROPERTIES
The Company's executive, administrative, manufacturing and
research and development facilities are located in San Diego, California. On
February 8, 1994, the Company purchased the land underlying such facilities and
the 65,000 square-foot building located thereon for approximately $7,700,000.
The Company believes that its current facilities are adequate for its present
needs.
PBI, which was acquired during the fourth quarter of fiscal
1995, initially had three leased facilities. The leases related to two of PBI's
production facilities were terminated on March 31, 1995 and April 30, 1995. The
remaining facility lease terminated on October 15, 1995. All of the PBI business
activities have been consolidated into the Quidel facilities.
Item 3. LEGAL PROCEEDINGS
The Company received a letter dated April 24, 1992 from the
United States Environmental Protection Agency (the "EPA") notifying the Company
that it is a potentially responsible party for cleanup costs at a federal
Superfund site, the Marco of Iota Drum Site (the "Marco Site"), near Iota,
Louisiana. Documents gathered in response to such letter indicate that the
Company sent a small amount of hazardous waste to facilities in Illinois. It is
possible that subsequently, such waste could have been transshipped to the Marco
Site. The EPA letter indicates that a similar notice regarding the Marco Site
was sent by the EPA to over 500 other parties. At this time, the Company does
not know how much of its waste may have reached the Marco Site, the total volume
of waste at the Marco Site or the likely site remediation costs. Based upon the
small amount of waste involved, however, the Company does not believe at this
time that the resolution of this matter will have a material adverse effect on
the Company.
Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not applicable.
EXECUTIVE OFFICERS OF THE REGISTRANT
The names, ages and positions of all executive officers of the
Company as of June 7, 1996 are listed below, followed by a brief account of
their business experience during the past five years. Officers are normally
appointed annually by the Board of Directors at a meeting of the directors
immediately following the Annual Meeting of Stockholders. There are no family
relationships among these officers nor any arrangements or understandings
between any officer and any other person pursuant to which an officer was
selected. None of these officers has been involved in any court or
administrative proceeding within the past five years adversely reflecting on the
officer's ability or integrity.
Steven T. Frankel, 53, Chief Executive Officer, President and
Chief Operating Officer, joined Quidel in June 1992 as President and Chief
Operating Officer. In May 1994, Mr. Frankel was elected Chief Executive Officer
of the Company. Mr. Frankel has over 25 years of experience in the areas of
sales and marketing to the medical professional and consumer markets. Most
recently as the head of the Asia Pacific Division of Becton Dickinson, he was
responsible for sales and marketing, manufacturing and country operations. Prior
to establishing the Asia Pacific Division in 1985, Mr. Frankel was President of
Becton Dickinson's U.S. Consumer Products Division and also had similar
responsibility for Becton Dickinson's European Consumer Products Division.
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Steven C. Burke, 51, Vice President - Finance and
Administration and Chief Financial Officer, joined Old Quidel in 1986. From May
1984 until August 1986, he was Vice President, Controller of American Bentley, a
subsidiary of American Hospital Supply. Mr. Burke is a Certified Public
Accountant.
Darryll J. Getzlaff, 45, Vice President - Human Resources,
joined Old Quidel in April 1987 with nine years of personnel management
experience, with special expertise in recruiting, management development and
equal opportunity. Mr. Getzlaff was Personnel Director, Corporate Marketing, for
the Ernest & Julio Gallo Winery from December 1984 until March 1987.
David C. McCaslin, 46, Senior Vice President - Strategic
Partnering, joined Old Quidel in 1987 as Vice President for Manufacturing and
Operations. In 1992, he assumed responsibility for corporate development,
licensing and international sales, was named Senior Vice President of Sales and
Marketing in April 1994, and became the Senior Vice President of Strategic
Partnering in February 1996.
Lauren G. Otsuki, 43, Vice President - Operations, joined Old
Quidel in May 1983 and held numerous positions in Operations from 1983 to 1989,
including Manager of Quality Control, Manager of Process Development and
Director of Manufacturing. From November 1989 to January 1992 she was the
Director of Business Development and in January 1992 became the Vice President
of Operations.
Allan D. Pronovost, Ph.D., 44, Vice President - Research and
Development, joined Old Quidel in April 1987. Dr. Pronovost has over 12 years
of experience in the diagnostic industry and held various key research and
development positions at Eastman Kodak from 1986 to March 1987, Ortho
Diagnostic Systems, Inc. from 1983 to 1986, and E.I. duPont Corporation from
1980 to 1983. Dr. Pronovost received his post-doctoral clinical training at
Yale University School of Medicine and received his Ph.D. degree in virology
from the University of Rhode Island. He has a number of patents and has
published numerous papers in immunology and diagnostic assay methods.
Jeanne Kettlewell Russell, 41, Vice President - Business
Development, joined Quidel through the acquisition of PBI. She had been the Vice
President of Sales and Marketing at PBI since affiliating with the small
start-up company in 1987. Prior to PBI, Mrs. Russell spent eight years in
various sales and marketing management positions with Baxter Healthcare/American
Hospital Supply.
John D. Tamerius, Ph.D., 50, Vice President - Clinical
Laboratory Business, joined Old Quidel in August 1989 and assumed responsibility
for quality assurance and clinical and regulatory affairs. In April 1994, Dr.
Tamerius became responsible for the research and development, manufacture and
sales and marketing activities for the Company's clinical laboratory business.
From 1983 to 1989, Dr. Tamerius served as Vice President of Research and
Development for Cytotech, Inc. where he was in charge of Corporate Research
Programs and Clinical and Regulatory Affairs. Before co-founding Cytotech, Inc.,
Dr. Tamerius was a postdoctoral fellow at the Fred Hutchinson Research Center in
Seattle, Washington from 1976 to 1978 and a research associate at the Research
Institute of Scripps Clinic in San Diego, California from 1978 to 1983. Dr.
Tamerius received his M.S. and Ph.D. degrees in Microbiology and Immunology from
the University of Washington in 1976.
Robin G. Weiner, 40, Vice President - Clinical Development and
Regulatory Affairs, joined Old Quidel in March 1982. She has over twelve years
experience in regulatory affairs and has held numerous management positions at
Quidel in Operations and Clinical/Regulatory. From December 1992 to July 1995
she was Senior Director of Clinical, Regulatory and Quality Systems and in July
1995 was promoted to Vice President.
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Elliot Werber, 50, Vice President - Sales and Marketing,
joined Quidel in May 1996. He was most recently Vice President of Sales and
Marketing for the Primary Care Market area of General Medical, the nation's
largest distributor of medical products to physicians' offices, clinics, surgery
centers and nursing homes. Mr. Werber joined General Medical in 1994, after the
merger with F.D. Titus and Son, where he was Director of Sales since 1992. From
1980 to 1991, he held a series of increasingly responsible sales and marketing
management positions in the medical and surgical supply industry. Mr. Werber
began his career in healthcare in 1972 with the Kendall Company and held sales
management positions until 1978. He then joined the Clay Adams Division of
Becton Dickinson in 1978 as Western Region Manager.
PART II
Item 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED
STOCKHOLDER MATTERS
The information required by this item is included on page 22
of the Registrant's 1996 Annual Report and is incorporated herein by reference.
Item 6. SELECTED FINANCIAL DATA
The information required by this item is included on page 1 of
the Registrant's 1996 Annual Report and is incorporated herein by reference.
Item 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
The information required by this item is included on pages 10
- - 12 of the Registrant's 1996 Annual Report and is incorporated herein by
reference.
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The information required by this item is included on pages 13
- - 21 of the Registrant's 1996 Annual Report and is incorporated herein by
reference.
Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING
AND FINANCIAL DISCLOSURE
Not applicable.
PART III
Item 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
The information required by this item is included in the
sections entitled "Election of Directors" and "Executive Compensation and Other
Information - Compliance with Section 16(a) of the Exchange Act" of the Proxy
Statement which will be filed with the Securities and Exchange Commission no
later than 120 days after the close of the fiscal 1996 year and is incorporated
herein by reference and is included in the section entitled "Executive Officers
of the Registrant" in Part I of this Report.
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Item 11. EXECUTIVE COMPENSATION
The Company maintains certain employee benefit plans and
programs in which its executive officers are participants. Copies of these plans
and programs are set forth or incorporated by reference as Exhibits 10.1, 10.4,
10.5, 10.6, 10.8, and 10.12 to this report. The additional information required
by this item is included in the section entitled "Executive Compensation and
Other Information" of the Proxy Statement which will be filed with the
Securities and Exchange Commission no later than 120 days after the close of the
fiscal 1996 year and is incorporated herein by reference.
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT
The information required by this item is included in the
sections entitled "Security Ownership of Certain Beneficial Owners" and
"Security Ownership of Management" of the Proxy Statement which will be filed
with the Securities and Exchange Commission no later than 120 days after the
close of the fiscal 1996 year and is incorporated herein by reference.
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
None.
PART IV
Item 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON
FORM 8-K
(a) Financial Statements, Financial Statement Schedules
and Exhibits
I. Financial Statements. The following Financial
Statements of the Registrant listed below are
incorporated herein by reference from the
following pages of the 1996 Annual Report:
PAGE IN
ANNUAL REPORT
-------------
1. Report of Ernst & Young LLP, Independent Auditors 23
2. Consolidated Balance Sheets --
March 31, 1996 and 1995 14
3. Consolidated Statements of Operations --
Years ended March 31, 1996, 1995 and 1994 13
4. Consolidated Statements of Stockholders' Equity --
Years Ended March 31, 1996, 1995 and 1994 16
5. Consolidated Statements of Cash Flows --
Years Ended March 31, 1996, 1995 and 1994 15
6. Notes to Consolidated Financial Statements 17-21
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II. Financial Schedules. None.
(b) Reports on Form 8-K filed in the fourth quarter of
fiscal 1996:
None.
(c) Exhibits:
Exhibit
Number
------
3.1 Certificate of Incorporation, as amended.
(Incorporated by reference to Exhibit 3.1 to the
Registrant's Current Report on Form 8-K dated February
26, 1991.)
3.2 Amended and Restated Bylaws. (Incorporated by
reference to Exhibit 3.2 to the Registrant's Current
Report on Form 8-K dated June 16, 1995.)
3.3 Certificate of Designations of the Series B Preferred
Stock. (Incorporated by reference to Exhibit 4.1 to
the Registrant's Current Report on Form 8-K dated
January 5, 1995.)
10.1* Registrant's 1983 Employee Stock Purchase Plan, as
amended. (Incorporated by reference to Exhibit 10.1 to
the Registrant's Current Report on Form 8-K dated
February 26, 1991.)
10.2 Form of Indemnification Agreement - Corporate Officer.
10.2.1 Form of Indemnification Agreement - Corporate
Director.
10.3 Form of Warrant Agreement between Registrant and
American Stock Transfer & Trust Company.
10.4* Registrant's 1990 Employee Stock Option Plan.
(Incorporated by reference to Exhibit 10.3 to the
Registrant's Quarterly Report on Form 10-Q for the
quarter ended September 30, 1990.)
10.5 Registrant's 1990 Director Option Plan. (Incorporated
by reference to Exhibit 10.4 to the Registrant's
Quarterly Report on Form 10-Q for the quarter ended
September 30, 1990.)
10.6 Registrant's Amended 1981 Stock Option Plan, as
revised. (Incorporated by reference to Exhibit 10.5 to
the Registrant's Quarterly Report on Form 10-Q for the
quarter ended September 30, 1990.)
10.7 Common Stock and Warrant Purchase Agreement dated
November 2, 1990 between Morgan Investment Corporation
and Old Quidel, including form of Common Stock
Warrant. (Incorporated by reference to Exhibit 10.6 to
the Registrant's Quarterly Report on Form 10-Q for the
quarter ended September 30, 1990.)
10.8 Registrant's Amended and Restated 1982 Incentive and
Nonstatutory Stock Option Plans, including Form of
Option Agreement. (Incorporated by reference to
Exhibit 10.28 to the Registrant's Registration
Statement No. 33-38324 on Form S-4 filed on December
20, 1990.)
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10.9 Form of Registration Rights Agreement of the
Registrant. (Incorporated by reference to Appendix C
to the final Joint Proxy Statement/Prospectus dated
January 4, 1991 included within Amendment No. 2 to the
Registrant's Registration Statement No. 33-38324 on
Form S-4 filed on January 4, 1991.)
10.10 Common Stock and Warrant Purchase Agreement dated
January 31, 1991, by and among Old Quidel, John
Hancock Capital Growth Fund IIB L.P., John Hancock
Capital Growth Fund III L.P., H&Q Healthcare
Investors, S.R. One, Limited and Golodetz Finance
Company, S.A., including form of Common Stock Warrant.
(Incorporated by reference to Exhibit 10.52 to the
Registrant's Current Report on Form 8-K dated February
26, 1991.)
10.11 Assumption Agreement dated January 31, 1991.
(Incorporated by reference to Exhibit 10.52.1 to the
Registrant's Current Report on Form 8-K dated February
26, 1991.)
10.12* Summary of Management Incentive Compensation Plan as
in effect in fiscal 1997.
10.13 Warrant to Purchase Common Stock issued to Imperial
Bank. Issued February 8, 1994, 117,871 shares with an
initial exercise price of $5.94 per share. Warrant
expires February 8, 1999. (Incorporated by reference
to Exhibit 10.43 to the Registrant's Form 10-Q dated
December 31, 1993.)
10.14 Consulting Agreement, dated May 12, 1994, between the
Registrant and Scott L. Glenn and SR Associates.
(Incorporated by reference to Exhibit 10.45 to the
Registrant's Form 10-K dated March 31, 1994.)
10.15 Trademark License Agreement dated October 1, 1994
between the Registrant and Becton Dickinson and
Company regarding the Q- Test trademark.
10.16 Security and Loan Agreement with Imperial Bank to loan
70% of eligible accounts receivable up to $3,000,000.
Dated March 29, 1995.
10.17 Warrant to Purchase 275,000 Shares of Common Stock
issued to Genesis Merchant Group Securities on May 16,
1995 at an initial exercise price of $4.50 per share.
Warrant expires January 15, 2000.
10.18 Stock Purchase Agreement dated January 5, 1995 between
Registrant and Eli Lilly & Company for the sale of all
the outstanding capital stock of Pacific Biotech, Inc.
(Incorporated by reference to Exhibit 2.1 to the
Registrant's Form 8-K dated January 5, 1995.)
13.1* Certain portions of the 1996 Annual Report to
Stockholders for the fiscal year ended March 31, 1996
which have been incorporated herein by reference.
23.1* Consent of Ernst & Young LLP, Independent Auditors.
27* Financial Data Schedule.
* Filed herewith.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the
Securities Exchange Act of 1934, the Registrant has duly caused this Report to
be signed on its behalf by the undersigned, thereunto duly authorized.
QUIDEL CORPORATION
Date: June 27, 1996 By: /S/ STEVEN C. BURKE
-----------------------------------
Steven C. Burke
Vice Pres. - Finance and Administration
(Chief Financial Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934,
this Report has been signed below by the following persons on behalf of the
Registrant and in the capacities and on the date indicated.
Date: June 27, 1996
/S/ RICHARD C.E. MORGAN /S/ ROCKELL N. HANKIN
- -------------------------------------- ---------------------------------------
Richard C.E. Morgan Rockell N. Hankin
Chairman of the Board Director
/S/ STEVEN T. FRANKEL /S/ MARY LAKE POLAN
- -------------------------------------- ---------------------------------------
Steven T. Frankel Mary Lake Polan
President and Chief Executive Officer Director
(Principal Executive Officer)
Director
/S/ JOHN D. DIEKMAN /S/ FAYE WATTLETON
- -------------------------------------- ---------------------------------------
John D. Diekman Faye Wattleton
Director Director
/S/ THOMAS A. GLAZE /S/ STEVEN C. BURKE
- -------------------------------------- ---------------------------------------
Thomas A. Glaze Steven C. Burke
Director Vice Pres. - Finance and Administration
(Principal Financial Officer and
Principal Accounting Officer)
/S/ ROGER F. GREAVES
- --------------------------------------
Roger F. Greaves
Director
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