Back to GetFilings.com
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
------------------------
FORM 10-K
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT
OF 1934
For the Fiscal Year Ended December 31, 1997 or
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE
ACT OF 1934
For the Transition period from to .
Commission file number: 0-27596
CONCEPTUS, INC.
(Exact name of Registrant as specified in its charter)
DELAWARE 97-3170244
(State or other jurisdiction of incorporation (I.R.S. Employer Identification No.)
or organization)
1021 HOWARD AVENUE
SAN CARLOS, CA 94070
(Address of principal executive offices)
Registrant's telephone number, including area code: (650) 802-7240
------------------------
Securities registered pursuant to Section 12(b) of the Act: NONE
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $0.003 par value per share
------------------------
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 than 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 based upon the closing sale price of the Registrant's Common Stock on
the Nasdaq National Market on February 28, 1998 was approximately $26,179,741 as
of such date. Shares of Common Stock held by each officer and director and by
each person who owns 5% or more of the outstanding Common Stock have been
excluded in that such persons may be deemed to be affiliates. This determination
of affiliate status is not necessarily a conclusive determination for other
purposes.
There were 9,506,928 shares of Registrant's Common Stock issued and
outstanding as of February 28, 1998.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Proxy Statement for the Registrant's 1998 Annual Meeting of
Stockholders are incorporated by reference in Part III of this Form 10-K.
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
THE FOLLOWING INFORMATION SHOULD BE READ IN CONJUNCTION WITH THE
CONSOLIDATED FINANCIAL STATEMENTS AND THE NOTES THERETO. THIS ANNUAL REPORT ON
FORM 10-K, AND IN PARTICULAR THE MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS, CONTAINS "FORWARD-LOOKING
STATEMENTS" WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT
OF 1995. IN THIS REPORT, THE WORDS "BELIEVES," "ANTICIPATES," "INTENDS,"
"EXPECTS" AND WORDS OF SIMILAR IMPORT, IDENTIFY FORWARD-LOOKING STATEMENTS. SUCH
FORWARD-LOOKING STATEMENTS INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES AND
OTHER FACTORS THAT MAY CAUSE THE ACTUAL RESULTS, PERFORMANCE OR ACHIEVEMENTS OF
CONCEPTUS TO BE MATERIALLY DIFFERENT FROM ANY FUTURE RESULTS, PERFORMANCE OR
ACHIEVEMENTS EXPRESSED OR IMPLIED BY SUCH FORWARD-LOOKING ACHIEVEMENTS. SUCH
FACTORS INCLUDE, AMONG OTHERS, THE FOLLOWING: THE UNCERTAINTY OF MARKET
ACCEPTANCE OF THE COMPANY'S PRODUCTS; THE LIMITED OPERATING HISTORY OF THE
COMPANY; THE ABILITY OF THE COMPANY TO DEVELOP AND MAINTAIN PROPRIETARY ASPECTS
OF ITS TECHNOLOGY; THE ABILITY OF THE COMPANY TO OBTAIN THE NECESSARY
GOVERNMENTAL CLEARANCES OR APPROVALS TO MARKET ITS PRODUCTS; INTENSE COMPETITION
IN THE MEDICAL DEVICE INDUSTRY; THE INHERENT RISK OF EXPOSURE TO PRODUCT
LIABILITY CLAIMS AND PRODUCT RECALLS; AND OTHER FACTORS REFERENCED IN THIS FORM
10-K. CERTAIN OF THESE FACTORS ARE DISCUSSED IN MORE DETAIL BELOW. GIVEN THESE
UNCERTAINTIES, PERSONS EVALUATING THE COMPANY AND ITS BUSINESS ARE CAUTIONED NOT
TO PLACE UNDUE RELIANCE ON SUCH FORWARD-LOOKING STATEMENTS. THE COMPANY ASSUMES
NO OBLIGATION TO UPDATE THESE FORWARD-LOOKING STATEMENTS TO REFLECT ACTUAL
RESULTS OR CHANGES IN FACTORS OR ASSUMPTIONS AFFECTING SUCH FORWARD-LOOKING
STATEMENTS.
PART I
ITEM 1. BUSINESS
THE COMPANY
Conceptus, Inc. ("Conceptus" or the "Company") designs, develops and markets
minimally invasive devices for reproductive medical applications. The Company's
current focus is to improve several diagnostic and therapeutic procedures in
gynecology. Conceptus's products are designed to improve the accuracy of
diagnostic procedures for infertility, to increase the safety of resectoscopic
procedures and to provide a non-surgical approach to fallopian tube
sterilization, the most commonly performed contraceptive procedure worldwide.
Conceptus has developed proprietary micro-catheter and guidewire systems that
allow physicians to transcervically (through the cervix) access and navigate the
full length of the fallopian tubes in a nonsurgical approach. The Company
believes that its fallopian tube access systems will facilitate more rapid and
accurate diagnosis of fallopian tube diseases and disorders than conventional
diagnostic methods, which are known to be inaccurate, leading to more
appropriate selection of therapies, and ultimately, improved reproductive
outcomes. The Company also believes that its systems will allow many tubal
therapies for both infertility and permanent contraception which are currently
performed surgically to be performed transcervically, thereby reducing the cost,
trauma and recovery time associated with those therapies. The Company's catheter
systems are based on technology initially developed by Target Therapeutics, Inc.
("Target"), and licensed exclusively to Conceptus in the field of reproductive
physiology. Conceptus commenced marketing of its catheter systems
internationally for a number of applications in September 1995. Its ERA-TM- and
FUTURA-TM- resectoscope sleeves were introduced to the market in September 1997.
To date, Conceptus has received five 510(k) clearances to market applications of
its T-TAC-TM- (Transcervical Tubal Access Catheter) systems, two 510(k)
clearances for falloposcopy for proximal tubal occlusion ("PTO") and two 510(k)
clearances for resectoscopy in the United States.
Human reproductive diseases and disorders are increasingly common medical
problems in most developed countries. Infertility is one of the most common and
emotionally traumatic of reproductive disorders. In most countries, female
infertility appears to be increasing, both because of the increase in diseases
that damage the fallopian tubes, such as sexually transmitted diseases, and
because of the increasing tendency of women to defer childbearing until later in
life, when fertility begins to decline naturally. Studies indicate that five to
eight million couples in the United States (or up to 15% of couples of
child-bearing age (20-44)) are clinically infertile, and many studies indicate
that increasing numbers of patients are seeking medical treatment for
infertility. Fallopian tube infertility disorders are estimated to
2
affect 35% of the couples seeking treatment. It is currently estimated that
annual expenditures in the United States for the diagnosis and treatment of
infertility exceed $2.0 billion.
Conceptus is developing a broad range of procedure-specific systems based on
its platform transcervical tubal access technology. The Company's T-TAC system
assists physicians in accessing and navigating the fallopian tubes and is
designed to facilitate more accurate detection, and improved treatment, of tubal
disorders. The Company received five 510(k) clearances of its T-TAC system in
1995 and commenced marketing of the system for diagnosis of PTO in the United
States. Internationally, the Company is marketing its T-TAC system for diagnosis
of PTO as well as for an additional therapeutic application, tubal
recanalization. Published medical journal articles have shown that fallopian
tube catheter recanalization, when performed on patients previously diagnosed
with PTO, results in an average pregnancy rate that is more than twice that of a
single cycle of IN VITRO fertilization ("IVF").
The Conceptus STARRT-TM- (Selective Tubal Assessment to Refine Reproductive
Therapy) Falloposcopy system combines the Company's proprietary micro-catheter
and guidewire tubal access technology with a specialized fallopian tube
microendoscope. This system permits direct visual examination of fallopian tube
endoluminal pathology for the first time without the need for surgery. Since
1994, the Company's system has been used in over 375 patients in the
International Multicenter Study of Falloposcopy (IMSF). In February 1997, the
Company received United States Food and Drug Administration ("FDA") 510(k)
clearance to market the initial configuration of its STARRT Falloposcopy system
for diagnosis of proximal tubal occlusion. The second falloposcopy system, which
the Company intends to market, received 510(k) clearance in February 1998.
Conceptus plans to develop a complete product line based on the STARRT
technology, including pursuing additional diagnostic indications for the system
and an expanded product line for endoscopically-guided tubal therapies. The
Company believes that its STARRT Falloposcopy system will allow physicians to
make more informed and accurate diagnoses of tubal functionality than current
approaches, leading to the selection of more effective courses of therapy.
Conceptus is also developing its S/TOP-TM- (Selective Tubal Occlusion
Procedure) system to provide a nonsurgical approach to fallopian tube
sterilization, the most common method of contraception worldwide. Due to the
limitations of other methods of contraception, almost half of the married women
in the United States age 35 or older have undergone a surgical fallopian tube
sterilization (tubal ligation), and, worldwide, surgical fallopian tube
sterilization is the most common contraceptive procedure among women who have
completed their families. The Company estimates that over 13,000,000 procedures
are performed annually worldwide. The S/TOP system utilizes the Company's
transcervical tubal access technology to deliver a proprietary micro-coil device
to the lumen of the fallopian tube. Conceptus believes that the S/TOP system
will allow physicians to perform fallopian tube sterilization in an office
setting without general anesthesia. The Company also believes that the
elimination of the requirement of surgery to perform the procedure will increase
both patient demand for the procedure and the availability of tubal
sterilization in developing countries, where surgical facilities may be limited.
The United States accounts for less than 20% of annual worldwide fallopian tube
sterilization procedures, and the Company estimates that the United States
market for such procedures exceeds $1.5 billion annually. Conceptus has
performed clinical feasibility studies in two different patient groups and is
currently engaged in a Phase II study of effectiveness.
In November 1996, Conceptus acquired Microgyn, Inc. ("Microgyn"), a private
medical device company, for $4.0 million paid in a combination of cash and
Common Stock of the Company. Additional contingent consideration (cash or stock)
is payable to the shareholders of Microgyn based upon the meeting of certain
future milestones. Microgyn is focused on developing products to increase the
safety and performance of resectoscope procedures, including therapeutic
hysteroscopy procedures, which utilize an endoscope to guide the selective
excision of abnormal uterine tissue. These procedures, including endometrial or
fibroid resection and endometrial ablation, are growing in clinical acceptance
because they are less invasive, non-incisional alternatives to the over 600,000
hysterectomies performed in the United States annually. The ERA Resectoscope
Sleeve is part of a system of products designed to permit the use
3
of isotonic, or physiologic, fluids during theraupeutic hysteroscopic
procedures. Currently, these procedures require the use of hypotonic fluids, the
absorption of which can lead to a number of clinical complications, including
death. Conceptus has received both a 510(k) clearance from the FDA for marketing
of the device in therapeutic hysteroscopy as well as a 510(k) clearance for
urologic use of the device. In October 1997, the Company purchased the exclusive
manufacturing rights to the ERA and FUTURA product line from Medical Scientific,
Inc.
The Company's goal is to become a global leader in reproductive healthcare
with an initial focus on women's reproductive health. The Company is directing
its marketing efforts, both domestically and internationally, toward those
interventional gynecologists who maintain high volume practices in infertility,
pre- and peri-menopausal conditions and gynecological endoscopy. Conceptus
intends to expand its product development and marketing efforts to address new
clinical applications in reproductive physiology, such as assisted reproductive
techniques and male reproductive disorders, in which the Company's technologies
may satisfy clinical needs or achieve cost reductions. In addition, the Company
is expanding its marketing efforts for the FUTURA products to include their
urologic applications.
Conceptus has an exclusive, worldwide, royalty-free license to the
reproductive applications of technology developed by Target, a manufacturer of
minimally invasive medical devices for neurovascular applications, which in 1997
became a separate business unit of Boston Scientific Corporation ("BSC"). BSC
beneficially owns approximately 15% of the Company's outstanding Common Stock.
See "Risk Factors--Influence of Boston Scientific Corporation." Conceptus was
formed in 1992 in response to reports by physicians of the successful use of
Target's products to access the fallopian tubes.
T-TAC-TM-, STARRT-TM-, S/TOP-TM-, VS-REGISTERED TRADEMARK-, SOFT
TORQUE-REGISTERED TRADEMARK-, SOFT SEAL-TM-, MINICERV-TM-,
ROBUST-REGISTERED TRADEMARK-, COAXESS-TM-, STARGATE-TM-, ERA-TM- AND FUTURA-TM-
ARE TRADEMARKS OF THE COMPANY. ALL OTHER TRADENAMES AND TRADEMARKS APPEARING IN
THIS FORM 10-K ARE THE PROPERTY OF THEIR RESPECTIVE HOLDERS.
HUMAN REPRODUCTION
Human reproduction has been the focus of increased scientific and medical
attention over the last twenty years. Contemporary lifestyle choices, such as
deferred childbearing, have led to an increased demand for certain reproductive
medical services, including the treatment of infertility and improved methods of
contraception. As a result, increasing numbers of OB/GYN specialists in the
United States treat infertility as well as other reproductive disorders, and the
number of family planning/reproductive health units in community hospitals in
the United States increased by over 300% between 1985 and 1991. Increasing
attention has been focused on the study of the fallopian tubes because of their
importance in the reproductive process, both in fertility and contraception. The
fallopian tubes are now recognized as not just a passive conduit between the
uterus and the ovaries, but as an essential organ in the reproductive process.
ROLE OF THE FALLOPIAN TUBES IN REPRODUCTION
The fallopian tubes are the organs in which conception occurs and thus, at
least one fallopian tube must be open to permit the passage of sperm. The
finger-like ciliated cells that line the tubal lumen must be healthy in order to
assist sperm in their migration toward the ovum, and, if conception occurs, to
reverse the direction of movement to propel the newly-fertilized ovum toward the
uterus. In addition, the tubal secretory cells must be functioning to create the
chemical environment necessary to achieve fertilization. As a result, the
fallopian tubes serve a critical function in the reproductive process and are
often the focus of treatment whether the objective is to increase a woman's
reproductive potential, such as in the treatment of infertility, or to decrease
her reproductive potential, such as in the performance of sterilization
procedures.
The fallopian tubes are very narrow and tortuous, convoluted in shape, with
many folds, and are delicate and difficult to access. As a result, they do not
lend themselves to easy study and treatment.
4
Because of the difficulty in accessing the fallopian tubes, current non-surgical
techniques for diagnosing fallopian tube diseases and disorders often do not
adequately or accurately delineate the nature, extent and location of tubal
pathology. Therapeutic choices for the treatment of infertility are equally
constrained by the difficulty in accessing the fallopian tubes, and therefore,
most fallopian tube therapies must be performed surgically. In addition,
although mechanical occlusion of the fallopian tubes is a highly effective means
of achieving female sterilization, the difficulty in accessing the fallopian
tubes has made it necessary to perform surgery in order to accomplish fallopian
tube sterilization.
INFERTILITY OVERVIEW
Infertility is one of the most common and emotionally traumatic of
reproductive disorders. The incidence of infertility appears to be increasing in
most developed countries due to both sociological and epidemiological factors.
Women in developed countries are increasingly deferring childbearing and studies
indicate that a 35-year old woman is almost three times as likely to be
infertile as a woman of 25. Studies also indicate that five to eight million
couples in the United States (or up to 15% of couples of childbearing age
(20-44) are clinically infertile, which has been defined as the failure to
conceive after one year of unprotected intercourse. Although the numbers of
couples seeking treatment have been steadily increasing, according to a study by
the National Center for Health Statistics (the "NCHS Study"), in 1988 only 1.4
million couples sought treatment for infertility. The Company believes that the
remaining couples did not seek medical treatment due to the cost, trauma and
poor outcomes associated with current diagnostic and therapeutic infertility
options. Despite the low percentage of infertile couples who seek care, current
estimates of the United States market for diagnosis and treatment of infertility
are in excess of $2.0 billion annually.
The cause of a couple's infertility is often very difficult to identify.
Frequently, both male and female factors exist in a couple having difficulty
conceiving. In addition, both hormonal and physical factors, such as fallopian
tube disorders or testicular abnormalities, commonly play a role. Finally, the
limitations of current diagnostic techniques often result in the underdiagnosis
and misdiagnosis of certain infertility factors. As a result, infertile couples
typically undergo a series of diagnostic evaluations to isolate the most
probable cause of their infertility.
Many factors that contribute to infertility, such as ovulatory disorders and
certain male factors, are well understood. However, fallopian tube diseases and
disorders, which are major causes of female infertility, remain poorly diagnosed
and inadequately treated today due to the difficulty in accessing the fallopian
tubes in order to perform diagnostic and therapeutic procedures. Despite both
the difficulty in diagnosing fallopian tube disorders and the limited number of
couples seeking infertility treatment, the Company estimates that over 490,000
couples each year (over one-third of those couples who seek infertility medical
care) are diagnosed with a fallopian tube factor as the sole or contributing
cause of infertility. This estimate further suggests that of the up to 8 million
couples experiencing infertility in the United States, fallopian tube
infertility may affect as many as 2.8 million. The Company believes the actual
incidence of fallopian tube infertility may be even higher than 2.8 million
women, both because the rate of diagnosis of tubal factors was established by
current diagnostic techniques, which are known to be inaccurate, and because of
the increasing incidence of diseases that can profoundly damage the fallopian
tubes, such as sexually transmitted diseases and other pelvic inflammatory
diseases.
The fallopian tubes are also very vulnerable to disease, especially to the
microorganisms that cause inflammatory diseases, such as chlamydia and
tuberculosis, which are reaching near epidemic levels in the United States.
Studies indicate that for each episode of pelvic inflammatory disease, there is
at least a 10% chance of subsequent infertility, irrespective of the type of
microorganism causing the infection. The fibrotic lesions, or scar tissue, that
can occur in the fallopian tubes as a consequence of infection, can cause
infertility by damaging several important tubal functions, including transport
of the egg and sperm and regulation of the chemical environment for conception.
These fibrotic lesions can also completely occlude the tubal lumen preventing
the passage of sperm to achieve fertilization.
5
Fallopian tubes are also often occluded by the natural build up of cellular
debris and mucous. This type of occlusion is often misdiagnosed as pathological
(a "false-positive" diagnosis) and may lead to inappropriate invasive
therapeutic interventions such as tubal surgery. As a result, due to the
inaccuracy of current, non-surgical tubal diagnostic methods, many physicians
have resorted to surgical approaches to diagnose tubal diseases and disorders.
CONTRACEPTION OVERVIEW
Throughout the world, there is a need for a safe, nonsurgical, permanent
contraceptive method. In the United States, approximately 46% of married women
over 35 years of age have undergone surgical fallopian tube sterilization (tubal
ligation) in part due to concerns about the safety and reliability of those
birth control methods they readily accepted at an earlier age. Consequently,
despite recent favorable clinical study data, patient concerns about the
long-term effects of oral contraceptives have limited their acceptance among
women over 40 in the United States, where only 3% of women age 40-44 use oral
contraceptives. Use of intrauterine devices ("IUD") in the United States has
declined in women of all age groups. Due to concerns that use of IUDs results in
increased incidence of pain and heavy menstrual bleeding that could mask the
symptoms of serious uterine disease, use of IUDs among women in the United
States age 40-44 is only 4%. For these reasons, women are seeking new methods of
permanent contraception. Increasingly, women are turning to surgical tubal
sterilization, representing the contraceptive method of choice in 51% of women
age 40-44 in the United States. In developing countries, where there are
concerns about population growth, 23% of all women have undergone surgical tubal
sterilization.
LIMITATIONS OF CURRENT APPROACHES TO FALLOPIAN TUBE INFERTILITY AND TUBAL
STERILIZATION
DIAGNOSTIC APPROACHES TO TUBAL INFERTILITY
The physician attempting to diagnose female infertility will nearly always
order or perform a procedure to determine whether the fallopian tubes are patent
(open) or occluded. The current diagnostic procedure of choice is
hysterosalpingography ("HSG"), which involves the injection of an x-ray contrast
medium (or dye) transcervically into the uterus to allow the physician to
observe and evaluate the flow of dye through the fallopian tubes under
fluoroscopy (x-ray). This procedure is often painful and is also known to be
highly inaccurate, with false-positive results in as many as 40% of
HSG-diagnosed cases of proximal tubal occlusion ("PTO"). Various factors are
believed to be responsible for these false indications of tubal occlusion,
including tubal spasm (a natural function of the tubes) and a build-up in the
tube of natural cellular debris and mucous. The Company estimates that HSG is
performed 600,000 times annually in the United States, and costs approximately
$100 to $300 per procedure, half of which is typically reimbursed.
Because of its high rate of inaccuracy, when HSG indicates PTO, the
physician will likely perform a surgical confirmatory procedure known as
laparoscopic chromopertubation (commonly called "lap and dye"). This procedure
is similar to HSG but involves transcervical injection of a colored dye, the
flow of which through the fallopian tubes is observed through an endoscope
surgically positioned in the abdomen. This procedure has a lower, but still
unacceptably high, rate (20-40%) of false-positive diagnosis of PTO, and also
involves the potential complications associated with the more invasive
laparoscopic surgical procedure. In any event, HSG and lap and dye are used
primarily to determine whether the tube is patent or occluded and not whether
any other tubal function is impaired. Lap and dye is performed an estimated
280,000 times annually in the United States, and typically costs in excess of
$2,000 per procedure. Most insurers will reimburse a single diagnostic
laparoscopy procedure per patient.
Because of the inability to access the fallopian tubes easily and
non-surgically in order to effect an accurate diagnosis of tubal health, it is
often difficult for physicians to select the most appropriate therapeutic option
for each patient. The difficulties in accessing the fallopian tubes also result
in current therapies for tubal infertility being far more invasive than
necessary.
6
THERAPEUTIC APPROACHES TO TUBAL INFERTILITY
Many patients with tubal infertility can be treated effectively with
corrective tubal surgery. However, pregnancy rates vary because of the
limitations of current tubal diagnostic techniques, which make it extremely
difficult to identify the patients for whom tubal surgery is appropriate
therapy. Thus, many patients undergo surgery whereupon either no pathology is
found or the tubes are so diffusely diseased as to preclude surgical repair.
Conversely, in many cases, other less appropriate therapies are often prescribed
for patients for whom surgery would be the optimal approach.
Because of the invasiveness of tubal surgery, which generally involves
either laparotomy, an open, abdominal surgery requiring general anesthesia and
multi-week recovery, or endoscopic surgery using a laparoscope, tubal surgery
should be restricted to those patients who can benefit from it. Both types of
surgery involve the risk of infection and the risks associated with use of
general anesthesia. In addition, the surgical procedure itself often leads to
collateral damage to the fallopian tube, usually in the form of post-surgical
adhesions, which may further decrease the patient's chances of conception. In
either a laparotomy or laparoscopy, a direct view of the fallopian tube lumen
should allow for an accurate diagnosis of the nature, location and extent of
tubal disease, enabling the physician to choose the appropriate therapy, if
treatment is indicated. However, peer review journal articles indicate that the
pregnancy rate subsequent to tubal surgery is only 30-35% and further suggest
that outcomes could be improved substantially if better diagnostic procedures
were available to identify appropriate surgical candidates and to determine the
type and extent of surgery required. Although most insurers will reimburse a
single tubal surgical procedure for a patient, due to disappointing surgical
outcomes, the frequency of tubal surgery in the United States has declined over
the last ten years, and the Company estimates that the procedure is currently
performed 20,000 times annually. A procedure typically costs between
$2,000-$10,000, depending on the degree of invasiveness.
In the United States, tubal infertility patients are increasingly being
referred to assisted reproductive techniques, primarily IVF. As with tubal
surgery, IVF is optimal therapy for certain tubal infertility patients,
particularly when both fallopian tubes are severely damaged or missing, or when
a combination of infertility factors in a couple makes it impractical to attempt
to correct each cause. IVF typically involves hyperovulation induced by
fertility drugs, and the harvesting of multiple eggs by way of a needle
aspiration through the abdominal wall directly to the ovary. Semen from the male
partner is then combined with the harvested eggs in a laboratory test-tube
fertilization procedure. Generally, after up to 72 hours, several embryos are
transferred by a transcervical catheter into the uterus for implantation.
The limitations of IVF have been well documented. Recent studies question
the safety of high dosages of fertility drugs. These drugs are generally
self-administered intramuscularly, which is not only painful, but often has a
powerful impact on emotional well-being. The IVF procedure is costly, with a
single harvest and transfer (a "cycle") costing up to $10,000 in the United
States. Many patients undergo multiple cycles in a course of therapy increasing
the cost to an amount up to $50,000 for a complete course of therapy, and IVF is
rarely reimbursed. In addition to the high cost of treatment, due to the
increased incidence of multiple births and delivery complications that can
accompany IVF, the total overall cost of IVF therapy can be substantial.
Finally, the success rate of IVF is disappointing, reported to be 19% live
births per cycle in the 1995 survey of the Society for Assisted Reproductive
Techniques (the "SART"). As a consequence of the emotional and physical trauma,
drug risks, and the high cost associated with IVF, fewer than 35,000 procedures
were performed in the United States in 1993.
Another factor that can not be overlooked in the treatment of infertility is
time: therapies that are inappropriate take time to administer, and additional
time is often required to assess outcomes before another therapeutic option is
explored. For many patients with fertility status already compromised by age,
time may be the most significant cost associated with the selection of
inappropriate therapy.
7
APPROACHES TO CONTRACEPTION
Surgical fallopian tube sterilization has become the fastest growing method
of contraception worldwide, especially among women over 35, because of its
reliability, and the absence of chronic side effects associated with the
procedure. Typically, fallopian tubes are ligated by cutting or cauterizing the
tubes, or by mechanical occlusion of the tubal lumen using clips or rings in a
surgical procedure such as a laparoscopy or laparotomy. The requirement of
surgery, however, is an obvious limitation of the procedure. The risks
associated with surgery, including the risk of general anesthesia, infection and
other complications, combined with concerns about cost and recovery time, make
the procedure less than ideal. In addition, in many developing countries, where
the need for permanent contraception is critical, there is a shortage of
community surgical facilities. In the United States, over 1,300,000 surgical
tubal sterilization procedures are performed annually. The average cost of these
procedures ranges from approximately $2,500 to approximately $8,000, depending
on the degree of invasiveness of the surgery.
CONCEPTUS' FIRST PLATFORM TECHNOLOGY: TRANSCERVICAL TUBAL ACCESS TECHNOLOGY
Conceptus has developed its minimally invasive transcervical tubal access
technology to address the clinical problems and technological limitations
presented by current fallopian tube infertility and tubal sterilization
approaches. The Company believes that the ability to directly and nonsurgically
access the fallopian tubes will lead to better reproductive outcomes by:
- Improving the accuracy of conventional diagnostic procedures performed to
assess tubal patency.
- Facilitating the performance of a new endoscopic tubal diagnostic
procedure, which will permit the diagnosis of several key aspects of tubal
functionality not adequately assessed today.
- Enabling physicians to select more appropriate tubal therapies, thereby
eliminating many unnecessary therapies.
- Allowing more tubal therapies to be performed nonsurgically, thus avoiding
the risks and costs of surgery and the potential for further
surgery-induced damage to the fallopian tubes.
- Accelerating the selection of appropriate infertility treatment, an
important consideration for women whose infertility status has already
been compromised by age.
- Providing a nonsurgical approach to fallopian tube sterilization, thereby
increasing patient demand for tubal sterilization and expanding its
availability in developing countries where surgical facilities may be
limited.
INFERTILITY PRODUCTS
The Company's proprietary transcervical tubal access technology consists of
specially designed, micro-catheters and guidewires, designed to be atraumatic,
which provide non-surgical access through the cervix and uterus and into the
fallopian tubes. These components are combined with the Company's other
procedure-specific products to produce the T-TAC system, the STARRT Falloposcopy
system, and the S/TOP system, as well as certain other systems in development.
8
The following table sets forth the clinical indications and regulatory
status of each of the Company's principal infertility products:
PRODUCT SYSTEMS CLINICAL INDICATIONS U.S. STATUS INTERNATIONAL STATUS
- ---------------------------- ---------------------------- ---------------------------- ----------------------------
T-TAC SYSTEM
VS (Variable Softness) Diagnostic tubal 510(k) clearance for: Marketed since September
Catheter Guidewires catheterization; therapeutic diagnosis of PTO; HSG; lap 1995, currently in 11
Soft Torque Uterine tubal catheterization; HSG; and dye; and intrauterine countries.
Catheter lap and dye; and insemination. System
Soft Seal Cervical intrauterine insemination. marketed since August 1995.
Catheter
Minicerv Cervical
Catheter
Progression Catheter
STARRT FALLOPOSCOPY SYSTEM
Stargate Catheter Operative fallopian tube 510(k) clearance for Operative system marketed in
Robust Guidewire endoscopy; in-office falloposcopy for PTO. Australia since September
Coaxess Uterine fallopian tube endoscopy. 1995.
Catheter
Vision Falloposcope
Gyne-Flex Stabilization
System
S/TOP SYSTEM
Tubal Access Catheter Non-surgical tubal Pre-hysterectomy testing in Efficacy trials commenced.
Intratubal Micro-Coil sterilization. progress.
Device
Delivery Wire
- ------------------------
TRANSCERVICAL TUBAL ACCESS TECHNOLOGY
VARIABLE SOFTNESS CATHETERS. The Company's Variable Softness Catheters ("VS
Catheters") are designed to enable the physician to atraumatically negotiate the
entire length of the intricate anatomy of the fallopian tubes. The
over-the-wire, co-axial design provides a conduit for guidewires, falloposcopes,
therapeutic devices, and fluids such as dyes, to the tubal lumen. The column
strength of the catheter gradually decreases from the relatively stiff proximal
section to a highly flexible distal portion. Proprietary design and blended
polymer materials are combined to create this transition in column strength that
facilitates the transmission of forward motion from the physician's hand (push),
while atraumatically negotiating (tracking) the tortuous anatomy of the tubes
more effectively than existing single-stiffness catheters. A radiopaque tip
facilitates visualization of the tip's path under fluoroscopy.
GUIDEWIRES. The Company's guidewires are soft, highly tactile devices used
for atraumatic navigation of the tortuous anatomy of the fallopian tubes. Like
the VS Catheter, these devices are characterized by a high column-strength
proximal end that gradually transitions to a highly flexible distal tip. The
guidewire is used by the physician to guide a VS Catheter to the intended site
at the ostium (the junction of the uterus and the fallopian tube) or in the
fallopian tube. The physician can then use the guidewire to recanalize (reopen)
the tube or can remove the guidewire from the catheter so that other instruments
or therapies can be delivered through the catheter to the intended site. The
guidewires offer a range of flexibility to accommodate a variety of patient
anatomies and physician preferences by utilizing variances in the tapering and
stiffness of the guidewires and other proprietary design features. Radiopaque
tips permit
9
visualization of the guidewires' progress through the fallopian tube under
fluoroscopy, and identification of occluded sites.
T-TAC SYSTEM
The Company's T-TAC system assists physicians in accessing and navigating
the fallopian tubes and is designed to facilitate more accurate detection and
treatment of tubal disorders. This system is frequently used in selective
injection during HSG, a procedure in which dye is injected sequentially into
each fallopian tube. Compared to standard HSG, selective injection is more
accurate and may be less painful for the patient. The T-TAC system can also be
used in selective salpingography ("SSG"), an enhancement to HSG, or during
laparoscopy as an enhancement to lap and dye. In addition, the system can be
used to recanalize occluded tubes and to deliver sperm accurately to an area
near the ostium in assisted reproductive techniques.
PROCEDURE-SPECIFIC PRODUCTS. The Company's T-TAC system consists of its
proprietary VS Catheter and guidewires, the Soft Torque Uterine Catheter, and
two different cervical catheters (the Soft Seal and the Minicerv).
The Soft Torque Uterine Catheter is introduced into the uterus through the
inner lumen of the Soft Seal Cervical Catheter. This 2.0 mm outer-diameter
catheter has a curved distal end and a soft atraumatic distal tip, which is used
to facilitate accurate placement of the tip near the tubal ostium. After
placement of the distal tip of the Soft Torque Uterine Catheter near the tubal
ostium, a guidewire and a VS Catheter can then be inserted through the inner
lumen of the Soft Torque Uterine catheter to gain access to the fallopian tube.
Multiple curve options of the catheter's design accommodate a variety of patient
anatomies. The tip and shaft are radiopaque to permit visualization of the
catheter under fluoroscopy to assist in the placement of the catheter. The Soft
Torque Catheter's 1.4 mm inner-diameter facilitates the injection of contrast
dye to help diagnose fallopian tube diseases and disorders in procedures such as
HSG or to deposit sperm near the ostium to facilitate artificial insemination.
The Soft Seal Cervical Catheter is designed to provide an atraumatic
mechanism for gaining access to and manipulating the uterus, for performing
standard HSG and as a platform for performing other uterine diagnostic
procedures. This 4.5 mm catheter provides access to the uterus without cervical
dilatation while a latex balloon at the tip is used to seal the cervical canal.
The catheter is made of polymers and incorporates a unique malleable stiffening
wire to add column strength during introduction to the uterus. Its 2.3 mm inner
diameter permits easy passage of other devices, such as another catheter.
The Minicerv Catheter is a miniature hysterosalpingography (HSG) catheter
designed for maximal patient comfort. The tiny 5 French shaft with a tip is
designed to be atraumatic and slide easily across the cervix for access to the
uterus. The shapeable mandrel provides column strength for insertion and can be
shaped to match patient anatomy. A polyurethane balloon avoids the latex
allergies which can be an issue with other hysterosalpingography catheters.
Because the polyurethane balloon material is non-compliant, it maintains its
shape once inflated and will not dislodge when manipulating the uterus.
CLINICAL AND REGULATORY STATUS. In July 1995, the Company received 510(k)
clearance for the use of the Company's T-TAC products for fallopian tube
catheterization to diagnose PTO under fluoroscopic, hysteroscopic or
laparoscopic guidance. The Company has also received 510(k) clearance for some
of the products in its T-TAC system for use during HSG, selective injection
during HSG, intrauterine insemination and in conjunction with laparoscopic
procedures.
The Company has received the CE Mark for its T-TAC system and all regulatory
approvals necessary to sell its T-TAC system for both diagnostic and therapeutic
fallopian tube catheterization indications in Switzerland, Canada, Australia and
South Africa, and is seeking approval to market these products in Israel.
10
STARRT FALLOPOSCOPY SYSTEM
The Company's STARRT Falloposcopy system is designed to enable the physician
to view the full length of the fallopian tube using a flexible, fiberoptic
endoscope to diagnose tubal diseases and disorders more effectively and
accurately, and thereby to prescribe more appropriate therapeutic measures. The
Company is developing two configurations of its STARRT Falloposcopy system: an
operative system and an in-office system. The operative system is being designed
to be used to diagnose the fallopian tubes adjunctively with a laparoscopic
abdominal diagnostic evaluation. The in-office system is being designed to
facilitate the performance of falloposcopy in an office setting by a physician
working without assistance on a mildly sedated patient.
PROCEDURE-SPECIFIC PRODUCTS. The STARRT Falloposcopy system consists of the
Stargate Catheter (a modified version of the VS Catheter), the Robust guidewire,
the Coaxess Uterine Catheter, the Vision Falloposcope and the Gyne-Flex
stabilization system, which may be used independently of the STARRT Falloposcopy
system.
The Company's Gyne-Flex stabilization system can be used to affix the
hysteroscope to the examining table to facilitate precise and secure positioning
of the hysteroscope in the uterus. To address many physicians' preference of
using their existing operative hysteroscopes to evaluate a patient's uterus at
the time that a falloposcopy procedure is performed, the Company's STARRT
Falloposcopy system can also be used with rigid operative hysteroscopes from
other suppliers. Conceptus has designed the Gyne-Flex to be compatible with the
most commonly used rigid hysteroscopes. In addition, the Gyne-Flex stabilization
system can also be used by itself to provide assistance in securing instruments
during laparoscopy.
After alignment of the hysteroscope with the ostium in the uterus, the
physician advances a specially designed Stargate Catheter and any guidewire
through the working channel of the hysteroscope to catheterize the fallopian
tube. When the guidewire and catheter reach the fimbrial end of the fallopian
tube or a point of resistance, the guidewire is removed and the Vision
Falloposcope is inserted into the catheter and advanced until it is aligned with
the distal tip of the catheter. This 0.45 mm diameter flexible fiberscope has
3,000 imaging fibers to provide quality imaging. The physician is then able to
view the entire length of the lumen of the fallopian tube in a retrograde manner
by gently withdrawing the catheter and falloposcope. Special design
characteristics of the Stargate Catheter permit good irrigation around the
falloposcope resulting in tubal distension, thereby enhancing visualization of
the tubal lumen.
Conceptus believes that a unique variation of its STARRT Falloposcopy system
can be developed which may allow the Company to offer a system which makes
in-office falloposcopy possible. Presently, falloposcopy is performed in
conjunction with laparoscopy. While this practice may continue to be a preferred
method for many physicians, the Company believes that the ability to perform
falloposcopy in an in-office, non-surgical procedure without concurrent
laparoscopy may appeal to physicians, especially those who do not typically
perform laparoscopy or other surgical procedures.
CLINICAL AND REGULATORY STATUS. 510(k) clearance for the initial
configuration of the STARRT Falloposcopy system was obtained in January 1997 for
the diagnosis of PTO. This application was supported by a United States safety
and feasibility study and the International Multicenter Study of Falloposcopy
(the "IMSF"). The United States safety and feasibility study, completed in
August 1995, was conducted in five centers in the United States and Australia
under an FDA-approved Investigational Device Exemption ("IDE"). Of fallopian
tubes studied that had a prior diagnosis of PTO from conventional diagnostic
methods, 61% were found to be patent on falloposcopic evaluation. Two cases of
tubal dissection (5%) were reported with no clinical sequelae noted in either
case. The PTO cases from the IMSF were also reviewed by FDA as part of the
510(k) filing. Of the 51 tubes diagnosed with PTO by HSG, falloposcopic
evaluation revealed patency in 37 tubes (72%). Of 47 tubes diagnosed with PTO by
lap and dye, falloposcopic evaluation revealed patency in 38 tubes (81%).
11
In 1994, a 21-center clinical study of the STARRT Falloposcopy system was
initiated in Europe and Australia by the core center for the IMSF at the
University of Heidelberg. Not limited to the diagnosis of PTO, over 375 patients
have been enrolled in this study to date which compares the diagnosis of
infertility by falloposcopy to conventional methods of diagnosis, HSG and
laparoscopic chromopertubation, or lap and dye. Study results from the first 315
patients enrolled indicate that in approximately 64% of the cases, falloposcopy
provided diagnostic information that was unobtainable by HSG, and in
approximately 58% of the cases, falloposcopy provided diagnostic information not
obtainable by lap and dye. The catheterization success rate in this trial was
84% and the visualization success rate was 82%. A 3.7% rate of complications has
been reported in this study, involving uterine and tubal perforation and tubal
dissections, with no serious complications reported to date.
Prior to the initiation of the IMSF, the Company's STARRT Falloposcopy
system was used in a 122 patient single-center study in South Australia
conducted by Dr. John Kerin, a pioneer in falloposcopy. In the study, Dr. Kerin
was able to identify endolumenal tubal pathology, categorize patients by
pathological findings and demonstrate statistically significant differences in
pregnancy outcomes in patients.
The Company has obtained the CE Mark for its STARRT Falloposcopy system and
all necessary regulatory approvals for sale of the system in certain foreign
countries including Switzerland, Canada, Australia and South Africa, and is
seeking approvals to sell the system in Israel. The Company may seek approvals
to market its STARRT Falloposcopy system products in other countries. See "Risk
Factors-- Dependence Upon T-TAC and Catheterization Products."
S/TOP SYSTEM
The Company is developing a non-incisional procedure for female
sterilization using the Company's proprietary transcervical tubal access system
and a unique tubal micro-coil device and delivery wire.
PROCEDURE-SPECIFIC PRODUCT. The Company is developing a proprietary
micro-coil sterilization device to be deployed permanently into each fallopian
tube using the Company's minimally invasive tubal access and delivery system and
the Company's unique delivery wire. The micro-coil device has been designed to
effectively occlude the lumen of the fallopian tube and be physically
incorporated into the tubal wall to prevent expulsion. The Company believes that
this device and procedure should reduce the clinical risks and costs associated
with most current tubal sterilization procedures while delivering a reliable,
safe method of sterilization.
CLINICAL AND REGULATORY STATUS. In 1995, the Company completed in vitro
feasibility studies and a successful animal study that demonstrated 100%
pregnancy prevention in the 20 animals in which the device remained correctly
placed.
In September 1995, Conceptus commenced a Phase I clinical study of the S/TOP
device under an Institutional Review Board ("IRB") approval with a
non-significant risk determination. This study involved the placement of the
S/TOP device in patients at the time of hysterectomy in order to assess the
ability to access the fallopian tube and place the device properly, and the
acute retention of the device. As of February 1998, 42 women have been enrolled
in this study. IDE approval has been obtained for an expanded Phase I clinical
study in 20 patients who are scheduled for a hysterectomy six to 12 weeks after
hysteroscopic placement of the S/TOP device. This study is designed to evaluate
histologically any adjacent tissue reaction and patient recovery from the device
placement procedure, in addition to the initial Phase I trial objectives.
Eighteen patients have been enrolled in this study and have undergone the S/TOP
device placement procedure in an office setting. The results from the first five
patients to undergo histologic evaluation of their fallopian tubes provides
early evidence of a local inflammatory tissue response to the device, as well as
damage to the tubal architecture, which is expected to be unfavorable to
conception. In addition, the HSG performed just prior to the hysterectomy
demonstrated complete occlusion in all tubes tested to date, with the exception
of the two tubes in which the device did not remain in the tube. An additional
Phase I study will be conducted to evaluate feasibility of placing the device
under fluoroscopic
12
and sonographic visualization. Ten patients will be enrolled in this study
anticipated to begin during the second quarter of 1998.
In 1997, the Company commenced a Phase II clinical study in Australia. Eight
patients scheduled for tubal sterilization have been enrolled to date. The study
will assess long-term device retention, effectiveness and safety. The Company
expects to follow this study with an expanded Phase II study, which will likely
involve 50 patients. A Phase III study, which will involve a larger patient
population and long-term follow up in support of a Pre-Market Approval ("PMA")
application, will follow.
CONCEPTUS' SECOND PLATFORM TECHNOLOGY: RESECTOSCOPY
With the acquisition of Microgyn, a privately held company, in November
1996, the Company can more effectively meet the needs of the interventional
gynecologist by using Microgyn's significant platform technology along with a
product portfolio based on the ERA and FUTURA-TM- Resectoscope Sleeves. In 1997,
the Company acquired the manufacturing rights for the ERA and FUTURA-TM- product
lines from Medical Scientific, Inc. The transfer of the manufacturing operation
to the Company was completed in March 1998.
The following table sets forth the clinical indications and regulatory
status of the Company's ERA and FUTURA product lines:
PRODUCT SYSTEMS CLINICAL INDICATIONS U.S. STATUS INTERNATIONAL STATUS
- ---------------------------- ---------------------------- ---------------------------- ----------------------------
ERA Resectoscope Sleeve Therapeutic hysteroscopy 510(k) clearance for Product released in the
gynecology United Kingdom in the fourth
quarter of 1997. CE Mark
completed first quarter
1998.
FUTURA Resectoscope Sleeve Therapeutic hysteroscopy 510(k) clearance for urology CE Mark completed first
quarter 1998.
ERA PRODUCT LINE
The ERA product line for gynecology focuses on developing products to
increase the safety and performance of resectoscope procedures, including
therapeutic hysteroscopy procedures, which utilize an endoscope to guide the
selective excision of abnormal uterine tissue. These procedures, including
endometrial or fibroid resection and endometrial ablation, are growing in
clinical acceptance because they are less invasive, non-incisional alternatives
to the over 600,000 hysterectomies performed in the United States annually.
In performing uterine therapy using a hysteroscope, the uterus must be
distended and the visibility maintained by use of an optically clear fluid.
Using a continuous flow of non-viscous media into and out of the uterine cavity,
the surgeon is provided a bloodless operating field in which tissue removal or
ablation can be carefully guided under direct visualization. Using monopolar
(RF) electrosurgical energy to cut or ablate adds a restriction on the type of
fluid that can be used: a non-conductive, hypotonic, non-physiologic distention
medium must be employed. Non-conductive fluids are electrolyte-free (hypotonic)
substances and therefore can change levels of vital electrolytes such as sodium,
potassium, and chloride in the blood stream of the patient. Fluids such as
mannitol, sorbitol and glycine are adequate for this purpose but present a risk
to the patient.
In therapeutic hysteroscopy, both small and large blood vessels are cut as
tissue is removed. Since the hypotonic fluids must be infused into the uterus
under pressure as high as 60-80 mmHg in order to distend the uterine cavity, a
large amount of fluid can be forced into venous channels, which normally
maintain pressure of about 20 mmHg. During the procedure, fluid loss into the
patient is carefully monitored, via fluid deficit calculations, comparing fluids
used versus fluids recovered. The surgeon is kept apprised of the
13
patient's fluid status, because of the complications associated with the
absorption of large amounts of hypotonic solutions. These include serious heart,
lung, and brain disorders, which sometimes result in coma or death.
The Company's ERA product line consists of the following products: a simple,
disposable ERA Resectoscope Sleeve, cutting loops and coagulating roller balls.
The ERA Resectoscope Sleeve, when installed on a standard hysteroscope, changes
the flow of electrosurgical energy delivered during cutting. This innovative
approach permits the use of isotonic solutions, such as normal saline, which are
physiologically compatible with the patient. The Company believes that the
ability to effectively use isotonic solutions during hysterscopic procedures
should minimize the risk of serious electrolyte disturbances and their
associated complications. The ERA product line is easy to use because it is
designed for total mechanical compatibility with existing hysteroscopic
instrumentation and power sources.
FUTURA PRODUCT LINE
While the Company will continue to focus on gynecological applications,
there is an important urological application for the resectoscope sleeve. The
FUTURA Resectoscope Sleeve enables the urologist to perform a Transurethral
Resection of the Prostate ("TURP") more safely by reducing the risk of certain
surgical complications. TURP is used to treat symptomatic enlargement of the
prostate, or benign prostatic hyperplasia ("BPH"). Approximately 180,000 TURP
procedures were performed in the United States in 1997.
TURP typically involves the electrosurgical removal of abnormal tissue
through a resectoscope, without the need for an incision. Conventional
electrosurgical procedures, however, require the use of hypotonic irrigation
solutions, the excessive absorbtion of which is associated with a potentially
catastrophic complication referred to as "TUR Syndrome." In order to reduce the
risk of TUR Syndrome, most hospitals have determined a strict surgical protocol
limiting the TURP procedure time, which may make it difficult for physicians to
completely resect abnormal prostate tissue in a single procedure. The FUTURA
Resectoscope Sleeve, which utilizes the same patented Microgyn technology used
for the gynecological application, enables the urologist to perform
transurethral procedures using isotonic (physiologic) solutions, eliminating the
risk of TUR Syndrome, and permitting the extra procedure time that may be needed
to complete resection of the prostate.
RESEARCH AND DEVELOPMENT
The Company's research and development activities are performed internally
by its 15-person research and development staff. The Company intends to expand
utilization of its proprietary technologies in a broad range of applications to
enhance the diagnosis and treatment of reproductive disorders, including male
reproductive disorders. Several physician-sponsored clinical studies have been
performed which the Company believes demonstrate the potential utility of the
Company's catheter, guidewire and micro-coil technologies for the treatment of
female and male reproductive disorders. Research and development expense for the
fiscal years ended 1997, 1996 and 1995 were $5.4 million, $3.8 million and $2.6
million, respectively.
MANUFACTURING
The Company manufactures its proprietary catheters and resectoscope sleeves
in environmentally controlled areas at its facility in San Carlos, California.
The Company has recently been inspected by the FDA, and is in substantial
compliance with all FDA requirements including FDA Good Manufacturing Practices
("GMP") for medical devices. The Company has been inspected by the California
Department of Health Services ("CDHS") and is registered with the State of
California to manufacture its medical devices and drugs. The State of California
Food and Drug Branch conducted a two-day inspection of the San Carlos facility
in February 1997 and as a result of that inspection, recommended that Conceptus
be issued
14
a drug license by the CDHS. See "Risk Factors--Dependence Upon Sole Source
Suppliers; Lack of Contractual Arrangements" and "--Limited Manufacturing
Experience."
MARKETING AND DISTRIBUTION
The Company's marketing strategy is designed to promote awareness of the
clinical efficacy and cost-effectiveness of the minimally invasive
interventional gynecology procedures in which the Company's products are used.
The Company implements this strategy by providing clinical and technical
information that encourages the physician to perform procedures utilizing the
Company's products. In the infertility area, a key component of the Company's
marketing strategy is a public relations campaign designed to use the mass media
to increase patient awareness of the benefits of less invasive and more accurate
diagnosis of fallopian tube diseases and disorders and improved tubal therapies
provided by transcervical access procedures. The Company also intends to work
closely with patient education, support and advocacy organizations. The Company
believes that it is critical to develop and maintain close working relationships
with patient organizations as well as physicians, as infertility patients are
increasingly involved in the selection of their therapy. In the therapeutic
hysteroscopy area, the Company plans to promote the benefits of this less
invasive alternative to hysterectomy and the significant safety and cost
advantages afforded by its ERA and FUTURA products. The Company's marketing
strategy will include developing influential product champions, publishing and
presenting on the safety and cost effectiveness of its products, conducting
workshops, exhibiting a strong presence at key gynecologic endoscopy meetings,
and selectively utilizing advertising, direct mail and telemarketing. See "Risk
Factors--Uncertainty of Market Acceptance."
The Company distributes its products in approximately 12 countries through a
combination of direct sales to customers and a worldwide network of
distributors. The Company currently sells its products to international markets
through a limited number of distributors who resell to physicians and hospitals.
Domestically, the Company sells its products through a small direct sales force
and U.S. distributors. Sales to distributors are made on open credit terms and
may include purchase discounts. Of the Company's sales for the fiscal year ended
December 31, 1997, 83% were derived from domestic sales and 17% were derived
from export sales to international distributors. Sales to three of the Company's
distributors, Mallinckrodt Group, Inc. ("Mallinckrodt"), Imagyn Medical
Technologies, Inc. ("Imagyn"), and Schering Health Care, Ltd. ("Schering")
accounted for approximately 63%, 27% and 5%, respectively, of total sales for
the year ended December 31, 1997. Since December 31, 1997, Imagyn has not
purchased any of the Company's products. In March 1998, Imagyn notified the
Company of its intent to terminate the distribution agreement between the
parties as of June 30, 1998. Although the Company and Imagyn are currently
renegotiating the terms of their relationship, there can be no assurance that
the parties will reach an agreement on such terms. There can be no assurance
that the Company will be able to obtain a suitable alternate distributor for its
products for urologic applications. The inability to attract new significant
distributors or the loss of one or more of the Company's distributors could have
a material adverse effect on the Company's business, financial condition and
results of operations. See "Risk Factors--Limited Sales, Marketing and
Distribution Experience; Emerging Market" and "--Dependence Upon International
Distributors and Sales."
The Company is focusing its United States marketing efforts primarily on the
Company's estimated 7,500 interventional gynecologists who maintain a
high-volume practice in gynecological endoscopy, and as a result, primarily
treat infertility and pre- and peri-menopausal symptoms. A key element of the
Company's marketing strategy is to develop relationships with prominent
physicians who are particularly active in interventional gynecology and to
involve these physicians in the Company's clinical and product development
activities. The Company intends to continue to build these relationships through
sales efforts, workshops and meetings to discuss clinical issues and treatments.
Interventional gynecology is an emerging market for which there is no proven
distribution channel in the United States. Accordingly, during the initial phase
of commercializing the Company's products, the
15
Company's marketing and sales strategy involves the use of a combination of
sales specialists directly employed by the Company and contract sales
representatives who have significant experience in physician detailing of
gynecological products. The role of the sales specialists and contract sales
representatives will be to demonstrate the use of the Company's products, while
educating physicians as to the intended clinical benefits of transcervical
fallopian tube access and the safety and cost effectiveness of performing
therapeutic hysteroscopy using isotonic solutions, using detailing techniques
similar to those commonly employed in the medical device industry. The Company
believes that this combination of direct sales specialists, employed in
territories with concentrated numbers of interventional gynecologists, and
contract sales representatives in other territories, will provide the highest
quality, most rapid and cost-effective means for introducing its initial
products. If the Company's product systems are successful, Conceptus intends to
expand its focused distribution channel in the United States interventional
gynecology market by increasing the number of sales representatives that are
directly employed by the Company. There can be no assurance that the Company's
sales or products available for sale will require a sales organization of direct
sales specialists and contract sales representatives, that the Company will be
able to attract and retain the necessary qualified sales personnel, that the
Company will be successful in creating an effective distribution channel for its
products or that the Company will be able to acquire the rights to market
additional products. See "Risk Factors--Limited Sales, Marketing and
Distribution Experience; Emerging Market" and "--Uncertainty of Market
Acceptance."
The Company believes that there are a number of small firms with products
that are complementary to the Company's but which to date have been unable to
establish an effective distribution channel for such products. As part of its
distribution strategy, the Company will seek to acquire or license the rights to
market complementary products from other companies which can be marketed to the
interventional gynecologist.
Although the Company is fully dedicated to meeting the needs of the
interventional gynecologist, some of the Company's products have applications in
two other specialty areas, radiology and urology. To capitalize on the
opportunities available in these other areas, the Company's distribution
strategy also includes entering into partnerships with leading companies in both
radiology and urology, allowing the Company to focus its internal marketing and
sales efforts on interventional gynecology. In July 1996, the Company announced
the signing of an agreement with Mallinckrodt, a major supplier of radiological
contrast media. Pursuant to this agreement, Conceptus granted Mallinckrodt
marketing rights for radiology applications of the T-TAC system in North,
Central and South America. The Company retained all marketing rights for its
T-TAC system in the gynecology market segment. If the Company and Imagyn are
unable to renegotiate the terms of their existing relationship pursuant to which
Imagyn distributes FUTURA products for urologic applications, the Company will
not have a relationship with a distributor of urologic products. There can be no
assurance that the Company will be able to obtain a suitable alternate
distributor for its products for urologic applications. There can be no
assurance that any of the Company's distribution partners will successfully
market the Company's products for applications in radiology or urology. The
failure to establish and maintain effective distribution partnerships for the
Company's products for these applications would have a material adverse effect
on the Company's business financial condition and results of operations. See
"Risk Factors--Limited Sales, Marketing and Distribution Experience; Emerging
Market."
In addition to the Mallinckrodt partnership, the Company currently markets
its products internationally primarily through established distributors of
specialty gynecological products, with one exception. In June 1996, the Company
appointed Schering, a major supplier of reproductive pharmaceuticals to the
interventional gynecology market, as Conceptus' exclusive distributor in the
United Kingdom to this market. The Company's products are currently marketed
through specialty distributors in the Netherlands, Spain, Sweden, Switzerland,
Australia, Israel and South Africa. The Company is negotiating with distributors
to cover the remaining countries in Europe, the Pacific Rim (including Japan)
and Latin America. The Company generally operates under written distribution
agreements with its distributors which grant the
16
distributor the exclusive right to sell the Company's products within a defined
territory. These distributors also typically market other medical products,
although the Company seeks to obtain covenants from its distributors prohibiting
them from marketing medical devices that compete directly with the Company's
products. The Company's distributors typically purchase the Company's products
at a discount from list price and resell the products to hospitals, clinics and
physicians. Sales to international distributors are usually denominated in
United States dollars. The end-user price is determined by the distributor and
varies from country to country. See "Risk Factors--Dependence Upon International
Distributors and Sales."
PATENTS, TRADE SECRETS AND LICENSES
Conceptus's policy is to aggressively protect its proprietary position by,
among other things, filing United States and foreign patent applications to
protect technology, inventions and improvements that are important to the
development of its business. The Company's strategy includes extending the
patent protection of its in-licensed technology (from Target) by filing
procedure-specific method patents wherever possible for the use of the Company's
products in new clinical applications, as well as aggressively pursuing patents
for all its other inventions and developments.
As of March 1, 1998, Conceptus had applied for 14 United States patents,
five of which have been issued to the Company, and has filed 25 foreign patents.
The Company's issued patents contain claims regarding guidewire manipulation, a
novel guidewire design and a delivery mechanism for a tubal occlusion device.
The pending applications cover various aspects of the Company's proprietary
tubal access platform technology, including certain claims specific to
falloposcopy products, as well as the Company's S/TOP device, allowing the use
of a physiologic solution during operative hysteroscopy and other products that
are currently, or in the future may be, used in conjunction with the Company's
product systems. Conceptus is also the licensee (from Target) for exclusive use
in the field of reproductive physiology, of substantial technology developed by
Target as described below, and has granted to Target an exclusive license in
certain fields of interventional medicine outside of the field of reproductive
physiology to certain Conceptus technology. Conceptus's exclusive license of
Target's technology is applicable to all technology available to the Company as
of February 1, 1996. Conceptus does not have any preferential rights for Target
technology developed following that date. As of March 1, 1998, Target held, and
Conceptus exclusively licensed from Target within the field of reproductive
physiology, 78 issued United States patents, numerous United States patent
applications and numerous foreign patents issued and applications pending
covering various aspects of its products and core technology. Target's issued
patents relate to the design of Target's micro-catheters, the initial patent for
which expires in June 2006, certain aspects of guidewire design and other
important aspects of Target's micro-catheter, guidewire and micro-coil
technologies. In the event that such Target patents are at any time invalidated,
the Company's proprietary position in the marketplace would be severely
compromised. In addition, should the Target technology licensed to the Company
be found to infringe upon a third party's technology, the Company's sale of
products based on such infringing Target technology could be limited. Finally,
in the event that the Company materially breaches the terms of its license from
Target, Target will have the right to terminate the license. Any such
termination of this license would deprive the Company of the right to develop or
sell products based on the licensed technology, which would have a material
adverse effect on the Company's business, financial condition and results of
operations. See "Risk Factors--Reliance on Patents and Protection of Proprietary
Technology."
17
GOVERNMENT REGULATION
UNITED STATES
The research, development, manufacture, labeling, distribution and marketing
of the Company's products are subject to extensive and rigorous regulation by
the FDA and, to varying degrees, by state and foreign regulatory agencies. The
Company's products are regulated in the United States as medical devices by the
FDA under the Federal Food, Drug, and Cosmetic Act (the "FDC Act") and most
require clearance or approval by the FDA prior to commercialization. In
addition, material changes or modifications to medical devices also are subject
to regulatory review and clearance or approval. Under the FDC Act, the FDA
regulates the research, clinical testing, manufacturing, safety, labeling,
storage, record keeping, advertising, distribution, sale and promotion of
medical devices in the United States. The testing for, preparation of and
subsequent review of applications by the FDA and foreign regulatory authorities
is an expensive, lengthy and uncertain process. The failure by the Company to
comply with FDA requirements could result in warning letters, fines,
injunctions, civil penalties, recall or seizure of products, total or partial
suspension of production, the government's refusal to grant premarket clearance
or premarket approval for devices, and criminal prosecution. Accordingly, the
Company has invested in building an experienced team of regulatory
professionals. For example, the Company's Senior Vice President, Clinical
Research, Regulatory Affairs and Quality Assurance was appointed by the FDA to
its OB/GYN Advisory Panel.
The FDA also has the authority to require clinical testing of certain
medical devices. If clinical testing of a device is required and if the device
presents a "significant risk," an IDE application must be approved prior to
commencing clinical trials. The IDE application must be supported by data,
typically including the results of laboratory and animal testing. If the IDE
application is approved by the FDA, clinical trials may begin at a specific
number of investigational sites with a maximum number of patients, as approved
by the agency. Sponsors of clinical trials are permitted to sell those devices
distributed in the course of the study provided such costs do not exceed
recovery of the costs of manufacture, research, development and handling. The
clinical trials must be conducted under the auspices of an IRB pursuant to FDA
regulations.
Generally, before a new device can be introduced into the market in the
United States, the manufacturer or distributor must obtain premarket
notification clearance under Section 510(k) of the Federal Food, Drug, and
Cosmetic Act ("510(k)") or a premarket approval ("PMA"). In addition, material
changes to medical devices are also subject to FDA review and clearance or
approval. If a medical device manufacturer or distributor can establish, among
other things, that a device is "substantially equivalent" in intended use and
technological characteristics to certain legally marketed devices, for which the
FDA has not required a PMA, the manufacturer or distributor may seek clearance
from the FDA to market the device by filing a 510(k). Though generally believed
to be a shorter, less costly regulatory path than a PMA, the 510(k) may need to
be supported by appropriate data establishing to the satisfaction of the FDA the
claim of substantial equivalence to the predicate device. In addition, the FDA
may require review by an advisory panel as a condition for 510(k) clearances,
which can further lengthen the regulatory process. In recent years, the FDA has
been requiring a more rigorous demonstration of substantial equivalence.
Following submission of the 510(k), the manufacturer or distributor may not
place the device into commercial distribution unless and until an order is
issued by the FDA finding the product to be substantially equivalent. In
response to a 510(k), the FDA may declare that the device is substantially
equivalent to another legally marketed device and allow the proposed device to
be marketed in the United States. The FDA, however, may require further
information, including clinical data, to make a determination regarding
substantial equivalence, or may determine that the proposed device is not
substantially equivalent and require a PMA. Such a request for additional
information or determination that the device is not substantially equivalent
would delay market introduction of the products that are the subject of the
510(k).
18
If a manufacturer or distributor of medical devices cannot establish that a
proposed device is substantially equivalent to a legally marketed device, the
manufacturer or distributor must seek premarket approval of the proposed device
through submission of a PMA. A PMA must be supported by extensive data,
including, laboratory, preclinical and clinical trial data to prove the safety
and effectiveness of the device as well as extensive manufacturing information.
Following receipt of a PMA, if the FDA determines that the application is
sufficiently complete to permit a substantive review, the FDA will "file" the
application. The PMA approval process can be lengthy, expensive and uncertain.
FDA review of a PMA generally takes approximately two years or more from the
date of filing to complete. If granted, the approval of the PMA may include
significant limitations on the indicated uses for which a product may be
marketed. The PMA process can take several years from initial filing and
requires the submission of extensive supporting data and clinical information.
No assurance can be given that any future products or applications developed by
the Company will not require approval under the more lengthy and expensive PMA
process. If the Company is required to obtain approval for any products pursuant
to the PMA procedure or, if the 510(k) process with respect to any products is
extended for a considerable length of time, the commencement of commercial sales
of the Company's products will be delayed substantially.
As of February 28, 1998, the Company has received five 510(k) clearances for
certain diagnostic and therapeutic indications of its T-TAC system. In addition,
the Company has received two 510(k) clearances for its STARRT Falloposcopy
system and its Stargate Catheter, both for the diagnosis of PTO. Conceptus has
also received two 510(k) clearances for its FUTURA Resectoscope Sleeve in
urologic applications and its ERA Resectoscope Sleeve in gynecological
applications.
The Company is also required to register as a medical device manufacturer
with the FDA and state agencies, such as the CDHS and to list its products with
the FDA. As such, the Company will be periodically inspected by both the FDA and
CDHS for compliance with GMP and other applicable regulations. These regulations
require that the Company manufacture its products and maintain its documents in
a prescribed manner. In July 1994, the Company's San Carlos facility was
inspected by the CDHS with no observations, and the Company was subsequently
granted a California medical device manufacturing license. In February 1997, the
Company's San Carlos facility was inspected by the CDHS, and granted a
California drug manufacturing license. In March 1997, the Company was inspected
by the FDA, with no action indicated.
The Company is required to provide information to the FDA on death or
serious injuries that its medical devices have allegedly caused or contributed
to, as well as product malfunctions that would likely cause or contribute to
death or serious injury if the malfunction were to recur. In addition, the FDA
strictly prohibits the marketing of approved devices for uses other than those
specifically cleared for marketing by the FDA. If the FDA believes that a
company is not in compliance with the law or regulations, it can institute
proceedings to detain or seize products, issue a recall, enjoin future
violations and assess civil and criminal penalties against the company, its
officers and its employees. Failure to comply with the regulatory requirements
could have a material adverse effect on the Company's business, financial
condition and results of operations.
The promotion of most products regulated by the FDA is subject to both FDA
and Federal Trade Commission jurisdictions. The Company is also subject to
regulation by the Occupational Safety and Health Administration and by other
government entities. Regulations regarding the manufacture and sale of the
Company's products are subject to change. The Company cannot predict what
impact, if any, such changes might have on its business, financial condition or
results of operations. See "Risk Factors-- Government Regulations."
INTERNATIONAL
Export sales of investigational PMA devices or devices not cleared for
commercial distribution in the United States to certain countries are subject to
FDA export permit requirements. In order to obtain such
19
a permit, the Company must provide the FDA with documentation from the medical
device regulatory authority of the country in which the purchaser is located,
stating that the sale of the device is not a violation of that country's medical
device laws. Recent regulations eliminate export approval requirements for
investigational devices subject to an approved IDE which are being imported into
certain countries.
The European Union has promulgated rules that require manufacturers of
medical products to obtain by mid-1998 the right to affix to their products the
CE mark, an international symbol of adherence to quality assurance standards and
compliance with applicable European Union Medical Device Directives. The ISO
9000 series of standards for quality operations has been developed to ensure
that companies know the standards of quality to which they must adhere to
receive European Union certification. ISO 9000 certification is one of the CE
mark certification requirements. Failure to receive the right to affix to a
Company product the CE mark will prohibit the Company from selling such product
in member countries of the European Union after mid-1998. The Company received
ISO certification in January 1998. Many countries in which the Company currently
operates or intends to operate either do not currently regulate medical devices
or have minimal registration requirements; however, these countries may develop
more extensive regulations in the future which could adversely affect the
Company's ability to market its products. In addition, significant costs and
requests by regulators for additional information may be encountered by the
Company in its efforts to obtain regulatory approvals. Any such events could
substantially delay or preclude the Company from marketing its products in the
United States or internationally. See "Risk Factors--Government Regulations."
THIRD-PARTY REIMBURSEMENT
Market acceptance of the Company's products in international markets may be
dependent in part upon the availability of reimbursement within prevailing
healthcare payment systems. Reimbursement systems in international markets vary
significantly by country, and by region within some countries, and reimbursement
approvals must be obtained on a country-by-country basis. Many international
markets have government-managed health care systems that determine reimbursement
for new devices and procedures. In most markets, there are private insurance
systems as well as government-managed systems. As in the United States, the
Company expects that ERA and FUTURA products will be covered within the
hysteroscopy procedure reimbursement framework. Large-scale market acceptance of
the Company's tubal catheterization, falloposcopy, sterilization and other
products will depend on the availability and level of reimbursement in
international markets targeted by the Company. Currently, the Company has been
informed by its international distributors that the tubal catheterization system
has been approved for reimbursement in countries in which the Company markets
its products. The Company's falloposcopy system has been approved for
reimbursement only in Australia. Obtaining reimbursement approvals can require
12 to 18 months or longer. There can be no assurance that the Company will
obtain reimbursement in any country within a particular time, for a particular
amount, or at all. Failure to obtain such approvals could have a material
adverse effect on market acceptance of the Company's products in the
international markets in which the Company is seeking approvals and could have a
material adverse effect on the Company's sales, business, financial condition
and results of operations.
Regardless of the type of reimbursement system, the Company believes that
physician advocacy of its products will be required to obtain reimbursement.
Availability of reimbursement will depend on the clinical efficacy and cost of
the Company's systems. There can be no assurance that reimbursement for the
Company's products will be available in the United States or in international
markets under either government or private reimbursement systems, or that
physicians will support and advocate reimbursement for use of the Company's
systems for all indications intended by the Company. Failure by physicians,
hospitals and other users of the Company's products to obtain sufficient
reimbursement from health care payors or adverse changes in government and
private third-party payors' policies toward reimbursement for procedures
employing the Company's products would have a material adverse effect on the
Company's
20
business, financial condition and results of operations. See "Risk
Factors--Uncertainty Relating to Third Party Reimbursement."
COMPETITION
In the infertility segment, the Company believes its primary current
competition to be existing methods for diagnosing and treating diseases and
disorders of the fallopian tubes. Accordingly, the Company competes with
manufacturers of products that are used in other methods for diagnosing and
treating tubal diseases and disorders, such as manufacturers of laparoscopic and
hysteroscopic devices and other products that provide more invasive access to
the fallopian tubes. The Company also competes with certain other companies that
manufacture catheters and guidewires for tubal catheterization and falloposcopic
devices. Additionally, certain smaller companies are developing alternative
catheter-based systems for the diagnosis and treatment of female reproductive
disorders which may compete directly with the Company's systems.
In the therapeutic hysteroscopy market, there are four major endoscope
companies (Karl Storz Endoscopy, Inc., Olympus, Inc., Circon Corporation and
Richard Wolf Medical Instruments Corporation) that account for the majority of
sales of the equipment and instruments used to perform these procedures.
Although the Company believes it has significant intellectual property
protection for its products, there can be no assurance that these companies or
others (e.g. electrosurgical generator manufacturers) will not develop
technology to enable electrosurgical therapeutic hysteroscopy to be performed
with isotonic solution. The major endoscope companies and others also market
cutting loops and coagulating roller balls which would be directly competitive
with those manufactured and marketed by the Company. There are also a number of
companies developing devices to perform endometrial ablation using different
energy sources.
The Company believes that its products have distinct advantages over those
of its competitors based on the Company's advanced proprietary micro-catheter
and guidewire technologies and its proprietary resectoscope sleeve technology.
However, many of the Company's competitors have substantially greater name
recognition and financial resources than the Company and have greater resources
and expertise in research and development, obtaining regulatory approvals,
manufacturing and marketing. Certain of these companies are developing and
marketing devices for the diagnosis and treatment of disorders of the female
reproductive system and others may choose to enter this market at a later date.
See "Risk Factors-- Competition; Uncertainty of Technological Change" and
"--Reliance on Patents and Protection of Proprietary Technology."
PRODUCT LIABILITY AND INSURANCE
The manufacture and sale of medical products involve an inherent risk of
exposure to product liability claims and product recalls. Although the Company
has not experienced any product liability claims to date, there can be no
assurance that the Company will be able to avoid significant product liability
claims and potential related adverse publicity. The Company currently maintains
product liability insurance with coverage limits of $5,000,000 per occurrence
and an annual aggregate maximum of $5,000,000, which the Company believes is
comparable to that maintained by other companies of similar size serving similar
markets. However, there can be no assurance that product liability claims in
connection with clinical trials or sale of the Company's products will not
exceed such insurance coverage limits, which could have a material adverse
effect on the Company, or that such insurance will continue to be available on
commercially reasonable terms, or at all. In addition, the Company may require
increased product liability coverage as more of its products are commercialized.
Such insurance is expensive and in the future may not be available on acceptable
terms, if at all. A successful product liability claim or series of claims
brought against the Company in excess of its insurance coverage, or a recall of
the Company's products, could have a material adverse effect on the Company's
business, financial condition and results of operations. See "Risk
Factors--Product Liability Risk and Recalls; Limited Insurance Coverage."
21
EMPLOYEES
As of March 1, 1998 the Company employed 67 individuals, 28 of whom were
engaged directly in research, development, regulatory and quality assurance
affairs, 9 in manufacturing and 30 in marketing, sales and administrative
positions. The Company also contracts with outside consultants. The Company is
dependent upon a number of key management and technical personnel. The loss of
the services of one or more key employees could have a material adverse effect
on the Company's business, financial condition and results of operations. The
Company's success will also depend on its ability to attract and retain
additional highly qualified management and technical personnel. The Company
faces intense competition for qualified personnel, many of whom are often
subject to competing employment offers, and there can be no assurance that the
Company will be able to attract and retain such personnel. None of the Company's
employees is covered by a collective bargaining agreement. Conceptus believes
that it maintains good relations with its employees. See "Risk
Factors--Dependence Upon Key Personnel."
EXECUTIVE OFFICERS OF THE COMPANY
The executive officers of the Company, and their ages, as of February 28,
1998, are as follows:
NAME AGE POSITION
- -------------------------------------------------- --- --------------------------------------------------------
Kathryn A. Tunstall............................... 47 President, Chief Executive Officer and Director
Steve Bacich...................................... 36 Vice President, Research and Development
Cynthia M. Domecus................................ 38 Senior Vice President, Clinical Research, Regulatory
Affairs and Quality Assurance
Sanford Fitch..................................... 57 Senior Vice President, Chief Financial Officer and
Director
James J. Messemer................................. 39 Vice President, Business Development
Robert Thomas..................................... 36 Vice President, Operations
MS. TUNSTALL joined Conceptus in July 1993 as President, Chief Executive
Officer and a director. Prior to joining Conceptus, Ms. Tunstall spent seven
years as an executive officer and in senior marketing positions of the Edwards
Less Invasive Surgery Division of Baxter International ("Baxter"), a division
engaged in the research and development, manufacturing and marketing of
cardiovascular catheters, serving as President from June 1990 to June 1993 and
serving as Vice President and Director of Worldwide Sales and Marketing from
November 1986 to June 1990. From 1980 to 1986, Ms. Tunstall held various
positions in manufacturing and marketing of McGaw Laboratories, a pharmaceutical
and medical device company, serving most recently as Vice President of
Marketing. She serves as a director of RESOLVE, a non-profit infertility
support, education and advocacy organization. Ms. Tunstall holds a B.A. in
Economics from the University of California and has also completed graduate
level studies in Business and Healthcare Administration.
MR. BACICH joined Conceptus in March 1997 as Vice President, Research and
Development. Prior to joining Conceptus, Mr. Bacich spent seven years as a
Co-founder and Director of New Product Development for Imagyn Medical, Inc., a
medical device manufacturer of gynecological products for infertility and
endoscopic procedures. From August 1987 to September 1989, Mr. Bacich held
engineering positions in research and development and serving most recently as
Senior Staff Engineer, Business Development for the Edwards Less Invasive
Surgery Division of Baxter. From 1985 to 1987, Mr. Bacich held research and
development positions at Mentor Corporation, a reconstructive surgery and
urology company. From 1983 to 1985, Mr. Bacich held research and development
positions at American Medical Optics, an ophthalmic medical device manufacturer
and Division of American Hospital Supply Corporation. Mr. Bacich holds a B.S. in
Biomedical Engineering from the University of California, San Diego.
MS. DOMECUS has served as Senior Vice President, Clinical Research,
Regulatory Affairs and Quality Assurance of Conceptus since May 1994. From March
1992 to May 1994 she served as Senior Director and
22
Director of Regulatory and Quality Affairs for Systemix, a biotechnology firm.
From 1986 to 1992, Ms. Domecus served in varying regulatory affairs capacities
with Collagen Corporation, a biomedical device manufacturer, serving most
recently as Director of Regulatory Affairs from January 1991 to March 1992. Ms.
Domecus has been certified by the Regulatory Affairs Certification Board of the
Regulatory Affairs Professional Society. In 1995, Ms. Domecus was appointed by
the FDA to its OB/GYN Advisory Panel as the industry representative. Ms. Domecus
holds a B.A. in Psychology from the University of the Pacific.
MR. FITCH has served as Vice President, Finance and Operations, Chief
Financial Officer and a director of the Company since December 1994 and was
promoted to Senior Vice President in February 1997. From January 1994 to
December 1994, Mr. Fitch served as Vice President, Finance and Operations and
Chief Financial Officer of Voyant Corporation, a video technology company. From
December 1990 to January 1994, Mr. Fitch served as Chief Financial Officer of
SanDisk Corp., a manufacturer of flash memory devices. From 1983 through 1989,
Mr. Fitch was the Vice President and Chief Financial Officer of Komag Inc., a
manufacturer of rigid media for the disk drive industry. Mr. Fitch holds an B.S.
in Chemistry and an M.B.A. from Stanford University.
MR. MESSEMER has served as Vice President, Business Development of Conceptus
since joining the Company in February 1993. From 1987 to February 1993, Mr.
Messemer held a variety of sales and sales management positions with SciMed Life
Systems, a medical device manufacturer and distributor, serving most recently as
Area Sales Director for the Northeast and Canada from January 1990 to January
1993. From 1984 to 1987, Mr. Messemer worked in sales in the Coronary
Angioplasty and Extracorporeal divisions of C.R. Bard, Inc. ("Bard"), a medical
products company. Prior to joining Bard, Mr. Messemer served as a sales
representative for Ciba Pharmaceutical Company, a pharmaceutical manufacturer.
Mr. Messemer holds a B.S. in Business Administration and Pre-Law from Texas Tech
University.
MR. THOMAS joined Conceptus in March 1997 as Vice President, Operations.
From March 1990 to February 1997, Mr. Thomas was a founder and Vice President of
Thomas Medical Products, a private medical device firm that was acquired by
Vital Signs, Inc. From November 1984 to February 1990, Mr. Thomas served in
various capacities in Operations Management with the Pharmaseal Division of
Baxter Healthcare in the Access Devices business unit. Mr. Thomas holds a B.A.
in Economics from Ursinus College.
During fiscal 1997, Dr. Lee Blumenfeld served as Vice President, Worldwide
Sales and Marketing, a position he held since 1995. Dr. Blumenfeld left the
Company effective as of December 31, 1997.
ITEM 2. PROPERTIES
The Company is currently occupying approximately 14,000 square feet in San
Carlos, California. The facility is subject to a lease which expires in
December, 1999. The Company has leased additional space in the amount of
approximately 16,397 square feet, also in San Carlos, California which is
subject to a lease which expires in May, 2002. The Company believes that it will
be able to lease additional space or renew its existing leases as necessary.
ITEM 3. LEGAL PROCEEDINGS
There are no material pending or threatened legal proceedings against the
Company. The Company from time to time is involved in routine legal matters
incident to its business. While management currently believes the amount of
ultimate liability, if any, with respect to these actions will not materially
affect the financial position, results of operations, or liquidity of the
Company, the ultimate outcome of any litigation is uncertain.
23
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No matters were submitted to a vote of stockholders of the Company during
the fourth quarter of the fiscal year ended December 31, 1997.
PART II
ITEM 5. MARKET FOR THE REGISTRANT'S COMMON STOCK AND RELATED SHAREHOLDER
MATTERS
The Company's Common Stock has been traded on the Nasdaq National Market
under the symbol CPTS since the effective date of the Company's initial public
offering on February 1, 1996. Prior to the initial public offering, no public
market existed for the Common Stock. The following table presents the high and
low closing sale prices for the Company's Common Stock as reported in the Nasdaq
National Market for the period indicated.
HIGH LOW
--------- ---------
Period from January 1, 1997 through March 31, 1997......................... $ 14.25 $ 9.375
Period from April 1, 1997 through June 30, 1997............................ $ 12.75 $ 8.50
Period from July 1, 1997 through September 30, 1997........................ $ 10.25 $ 6.625
Period from October 1, 1997 through December 31, 1997...................... $ 11.00 $ 4.125
As of February 28, 1998, the Company had approximately 130 stockholders of
record and approximately 1,780 beneficial owners of its Common Stock. The
Company's directors, executive officers and principal stockholders, including
BSC, beneficially owned, in the aggregate, approximately 22% of the Company's
outstanding Common Stock. These stockholders, if acting together, would be able
to influence substantially all matters requiring approval by the stockholders of
the Company, including any determination with respect to the acquisition or
disposition of assets by the Company, future issuances of Common Stock or other
securities by the Company, declaration of dividends on the Common Stock and the
election of directors. Such concentration of ownership may also have the effect
of delaying, deferring or preventing a change in control of the Company. See
"Risk Factors--Volatility of Stock Price" and "--Influence by Directors,
Executive Officers and Principal Stockholders." The Company has never paid cash
dividends on its Common Stock and does not anticipate paying cash dividends in
the foreseeable future. The Company intends to retain any future earnings for
reinvestment in its business. Any future determination to pay cash dividends
will be at the discretion of the Board of Directors and will be dependent upon
the Company's financial condition, results of operations, capital requirements
and such other factors as the Board of Directors deems relevant.
24
ITEM 6. SELECTED CONSOLIDATED FINANCIAL DATA
The following table presents selected consolidated financial data of the
Company. This historical data should be read in conjunction with the attached
consolidated Financial Statements and the related notes thereto and
"Management's Discussion and Analysis of Financial Condition and Results of
Operations" appearing in Item 7 of this Form 10-K.
PERIOD FROM
INCEPTION
(SEPTEMBER 18, YEAR ENDED DECEMBER 31,
1992) TO DECEMBER --------------------------------------------
31, 1993 1994 1995 1996 1997
----------------- --------- --------- ---------- ----------
STATEMENT OF OPERATIONS DATA:
Net sales........................................ $ -- $ 389 $ 243 $ 664 $ 1,426
Cost of sales.................................... -- 718 1,021 1,208 3,516
------- --------- --------- ---------- ----------
Gross profit..................................... -- (329) (778) (544) (2,090)
Operating costs and expenses:
Research and development....................... 1,237 1,778 2,589 8,509 5,429
Selling, general and administrative............ 1,081 1,894 2,805 4,824 6,323
------- --------- --------- ---------- ----------
Total operating expenses..................... 2,318 3,672 5,394 13,333 11,752
------- --------- --------- ---------- ----------
Loss from operations............................. (2,318) (4,001) (6,172) (13,877) (13,842)
Interest and investment income, net.............. 62 125 323 2,185 1,784
------- --------- --------- ---------- ----------
Net loss..................................... $ (2,256) $ (3,876) $ (5,849) $ (11,692) $ (12,058)
------- --------- --------- ---------- ----------
------- --------- --------- ---------- ----------
Basic and diluted net loss per share............. $ (1.39) $ (1.29)
---------- ----------
---------- ----------
Shares used in computing basic and diluted net
loss per share................................. 8,396 9,381
---------- ----------
---------- ----------
Pro forma basic and diluted net loss per share
(1)............................................ $ (1.37)
---------
---------
Shares used in computing pro forma basic and
diluted net loss per share (1)................. 4,273
---------
---------
1993 1994 1995 1996 1997
--------- --------- ---------- ---------- ----------
BALANCE SHEET DATA:
Cash, cash equivalents and short-term investments........ $ 1,260 $ 5,253 $ 5,082 $ 39,021 $ 27,058
Working capital.......................................... 976 5,089 4,407 37,078 26,608
Total assets............................................. 1,610 6,221 6,092 40,093 29,480
Long-term portion of debt and capital lease
obligations............................................ 22 264 153 34 1
Redeemable convertible preferred stock................... 3,465 11,453 16,624 -- --
Accumulated deficit...................................... (2,256) (6,132) (11,981) (23,673) (35,731)
Total stockholders' equity............................... (2,254) (6,125) (11,877) 37,595 27,504
- ------------------------
(1) See Note 1 to Notes to Consolidated Financial Statements for information
concerning calculation of pro forma basic and diluted net loss per share
25
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
OVERVIEW
Since its inception on September 18, 1992, Conceptus has been primarily
engaged in the design, development and marketing of minimally invasive devices
for reproductive medical applications. The Company's current focus is on
improving the safety of resectoscopic procedures, developing products for
improved diagnosis of infertility and providing a non-surgical approach to
fallopian tube sterilization, the most commonly performed contraceptive
procedure worldwide. The Company has a limited history of operations and has
experienced significant operating losses since inception. Operating losses are
expected to continue for at least the next several years as the Company
continues to expend substantial resources to fund clinical trials in support of
regulatory and reimbursement approvals, to conduct research and development, and
to expand marketing and sales activities.
The Company's initial commercial products, the T-TAC and STARRT Falloposcopy
systems, have generated limited sales to date. The Company currently sells its
products to international markets through a limited number of distributors who
resell to physicians and hospitals. Domestically, the Company sells its products
through a small direct sales force and U.S. distributors. Sales to distributors
are made on open credit terms and may include purchase discounts. In 1996 and
1995, the Company made adjustments to the profile of its distributors, resulting
in replacement and addition of new distributors in domestic and international
markets. In 1997, the Company added an additional domestic distributor. Although
the Company began marketing components of its T-TAC system in April 1995,
general marketing of the system commenced upon the receipt of a 510(k) clearance
for diagnosis of proximal tubal occlusion in August 1995. Sales in 1996 were
through a small direct sales force and two new significant distributors on open
credit terms and consisted primarily of commercial shipments of T-TAC products.
Sales in 1997 were through a small direct sales force and existing distributors,
as well as a new distributor, on open credit terms and consisted of commercial
shipments of T-TAC and FUTURA products.
In the fourth quarter of 1996 the Company presented results from the IMSF
study of its STARRT Falloposcopy system. Study data showed that use of the
STARRT Falloposcopy system altered infertility diagnosis in the majority of
cases versus conventional infertility diagnosis. In February 1998, the Company
received 510(k) clearance of its second generation STARRT catheter, the Stargate
Catheter, a component of the Company's STARRT Falloposcopy System, for the
diagnosis of PTO. The Stargate Catheter is a modification of the VS Falloposcopy
Catheter, which was previously cleared for marketing in the United States by the
FDA. The Stargate Catheter is designed to improve visualization of the fallopian
tube by reducing the amount light reflected off of tubal surfaces.
On November 26, 1996, the Company completed the acquisition of Microgyn, a
privately held medical device company developing products designed to improve
the safety and performance of resectoscope procedures, including therapeutic
hysteroscopy. The Company acquired all of the outstanding common stock of
Microgyn, Inc. in exchange for $3.0 million in cash on the acquisition date and
$1.0 million in stock paid six months after the acquisition date, plus $752,000
due to assumption of certain liabilities and related acquisition expenses. In
May 1997, the Company satisfied the $1.0 million accrued acquisition cost by
issuing 104,708 shares of Common Stock. Additional contingent consideration in
cash or stock, at the option of Conceptus, is payable to the former shareholders
of Microgyn based upon meeting certain future milestones. The acquisition was
accounted for using the purchase method. The Company is continuing product
development of the Microgyn product portfolio, clinical and marketing activities
and is developing a distribution strategy for both international and domestic
customers.
In the second half of 1997 the Company introduced the ERA and FUTURA
Resectoscope Sleeve products from the Microgyn technology portfolio. These
products allow the use of physiologic solution when performing hysteroscopic
procedures, which increases the safety of resection procedures by eliminating
the risk of dilutional hyponatremia, a complication that can lead to serious
heart, lung, and brain
26
disorders. The Company received 510(k) clearance for its FUTURA Resectoscope
Sleeve for urologic applications in the first quarter of 1997. In September
1997, the Company received 510(k) clearance for its ERA Resectoscope Sleeve for
gynecological procedures. Also in September 1997, the Company entered into a
marketing and distribution agreement with Imagyn, formerly UroHealth, Inc.,
granting Imagyn an exclusive, worldwide license to distribute products for
urologic applications of the resectoscope sleeve. Since December 31, 1997,
Imagyn has not purchased any of the Company's products. In March 1998, Imagyn
notified the Company of its intent to terminate the distribution agreement
between the parties as of June 30, 1998. Although the Company and Imagyn are
currently renegotiating the terms of their relationship, there can be no
assurance that the parties will reach an agreement on such terms. There can be
no assurance that the Company will be able to obtain a suitable alternate
distributor for its products for urologic applications. The inability to attract
new significant distributors or the loss of one or more of the Company's
distributors could have a material adverse effect on the Company's business,
financial condition and results of operations. The Company intends to sell the
ERA Resectoscope Sleeve for gynecologic applications in the United States and
internationally through a combination of a direct sales force and distributors
in certain markets and regions.
In the fourth quarter of 1997, the Company acquired the exclusive
manufacturing rights from Medical Scientific, Inc., the supplier of the
Company's ERA and FUTURA Resectoscope Sleeves. The manufacturing know-how
related to the ERA and FUTURA Resectoscope Sleeves has been transferred to the
Company's facility in San Carlos, with full production anticipated by the end of
the first quarter 1998. The acquisition and transfer of these manufacturing
rights resulted in additional cost of goods expenditures approximating $1.1
million.
Certain of the Company's products are manufactured by original equipment
manufacturers while others are manufactured by Conceptus at its location in San
Carlos, California. If the volume of T-TAC, STARRT, and ERA and FUTURA products
increases significantly, the Company expects to increase its direct
manufacturing operations in order to better control product costs and increase
gross margin. Future revenues and results of operations may fluctuate
significantly from quarter to quarter and will depend upon, among other factors,
actions relating to regulatory and reimbursement matters, the extent to which
the Company's products gain market acceptance, the rate at which the Company
establishes its domestic and international distributor network, the timing and
size of distributor purchases, the progress of clinical trials, and the
introduction of competitive products for diagnosis and treatment of the female
reproductive system.
The Company continues to devote significant resources to the product
development program for the S/TOP device, a non-surgical alternative to surgical
tubal ligation, the most commonly used method of sterilization. The system
utilizes a unique micro-coil designed to be permanently implanted into the
fallopian tube in order to obtain effective sterilization. Peri- and
pre-hysterectomy patients have participated in trials to determine the tissue
response to the implanted microcoil. In July 1997, the Company commenced a Phase
II efficacy study of the S/TOP system in Australia. The Phase II study involves
device placement in fertile women who desire permanent sterilization. Study
patients will be monitored for a minimum of two years.
RESULTS OF OPERATIONS
YEARS ENDED DECEMBER 31, 1997, 1996 AND 1995
Sales increased 115% to $1,426,000 in 1997 from $664,000 in 1996. This
increase was due to increased commercial shipments of the Company's T-TAC
products to a significant domestic distributor, as well as commercial shipments
of the Company's FUTURA products to a new domestic distributor. Sales increased
173% to $664,000 in 1996 from $243,000 in 1995. This increase was due to
increased commercial shipments of the Company's T-TAC products to a significant
domestic distributor and increased sales to international
27
distributors. Sales to domestic customers represented 83% of sales in 1997, 68%
of sales in 1996 and 48% of sales in 1995.
Cost of sales increased 191% to $3.5 million in 1997 from $1.2 million in
1996. This increase was primarily due to approximately $1.1 million associated
with the acquisition of the exclusive manufacturing rights of the Company's ERA
and FUTURA products from MSI, combined with increased unit shipments of T-TAC
and FUTURA products. Cost of sales increased 18% to $1.2 million in 1996 from
$1.0 million in 1995. This increase was primarily due to increased unit
shipments of T-TAC products.
Research and development ("R&D") expenses, which include clinical and
regulatory expenses, increased to $5.4 million in 1997 from $3.8 million in 1996
(net of $4.8 million of acquired in-process research and development) and $2.6
million in 1995. The increase of $1.6 million in 1997 and the prior year
increases were primarily attributable to the increased number of research and
development employees and related use of supplies, prototype materials and
inventory, and increased expenses associated with supporting various clinical
trials.
As discussed above, the Company expensed $4.8 million of acquired in-process
research and development in connection with the acquisition of Microgyn in 1996.
Selling, general and administrative ("SG&A") expenses increased to $6.3
million in 1997 from $4.8 million in 1996 and $2.8 million in 1995. The $1.5
million increase in 1997 and the $2.0 million increase in 1996 were primarily
due to the growth in marketing expenses associated with promoting the Company's
products and growth of United States and European sales and marketing personnel,
increased administrative costs required to support expanding operations and
increased administrative costs of being a public company,
Net interest and investment income decreased to $1.8 million in 1997 from
$2.2 million in 1996. The decrease is a result of lower average cash balances
due to the utilization of cash for operations. Net interest and investment
income increased to $2.2 million in 1996 from $323,000 in 1995. The increase in
1996 was due to higher average cash balances from proceeds of the initial public
offering in February 1996. Proceeds from these financing activities were
in