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SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-KSB
ANNUAL REPORT
Pursuant to sections 13 or 15(d) of The Securities Exchange Act of 1934
For the fiscal year ended February 28, 1997
Commission File Number 0-15382
GAMOGEN, INC.
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(Exact name of registrant as specified in its charter)
NEW YORK 13-3341562
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(State or other jurisdiction (IRS Employer
of incorporation or organization) Identification No.)
24 Carpenter Road, Chester, NY, 10918
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(Address of principal executive offices) (Zip Code)
(914) 469-2042
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(Registrant's telephone number, including area code)
Securities registered or to be registered pursuant to
Section l2(b) of the Act:
None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $.01 par value
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(Title of class)
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
during the past 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes X No
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Check if there is no disclosure of delinquent filers in response to
Item 405 of Regulation S-B is not contained in this form, and no disclosure
will 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-KSB or any amendment to this form 10-KSB. X
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Issuer's revenues for its most recent fiscal year: $343,675.
At February 28, 1997, the aggregate market value of the voting stock of the
registrant held by non-affiliates was approximately $15,400.
At February 28, 1997, the registrant had outstanding 1,230,000 shares of Common
Stock, $.01 par value.
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PART I
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Item 1. Business
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History of the Company
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Gamogen, Inc. (the "Company") was incorporated under the laws of the State of
New York, on March 17, 1986, by its parent company, Repro-Med Systems, Inc.
("Repro-Med") for the purpose of acquiring, developing and marketing three new
medical products for use in the treatment of impotence. In September 1986, the
Company acquired by assignment from Repro-Med, Dr. Adrian Zorgniotti, and
Andrew Sealfon, all rights to an injectable drug combination treatment for male
impotence and two related products: a drug intermixing delivery system and an
implantable prosthesis for dispensing drugs at a purchase price of $300,000.
The assignment of these three products included rights to all related
technology and products. On December 17, 1986, the Company completed a public
offering of 400,000 units consisting of one share of common stock and one
warrant to purchase one-half share of common stock at an offering price of
$5.25 per unit or an aggregate consideration of $2,100,000. The net proceeds to
the Company, after deduction of discounts, commissions and other expenses of
the offering were approximately $1,656,000.
On May 27, 1987, the Company acquired the rights to certain gynecological
products which it assigned to its Gyneco, Inc. ("Gyneco") subsidiary which
immediately commenced manufacturing and marketing a line of gynecological
products. (See "Gynecological Products").
On July 10, 1993, the Company acquired the rights to an Oral Treatment for Male
Impotence developed by Dr. Zorgniotti. On April 12, 1994 the Board of Directors
of the Company approved and on April 14, 1994 the Company signed with Zonagen,
a small US based biotechnology company, an agreement under which Zonagen
acquired all rights of Gamogen to the Company's Oral Treatment for Male
Impotence ("Impotence Agreement"). In exchange for the above rights the Company
received from Zonagen $100,000 in cash and, subject to certain FDA approvals
and Gamogen's agreement not to compete, future payments of $200,000 in
restricted common stock of Zonagen, valued based on the closing price on the
day due, and royalties on Zonagen's future sales of the Oral Treatment as
follows payable in cash to Gamogen. Future product royalties payable to Gamogen
under the Impotence Agreement are equal the following percentages of net sales
of the Oral Treatment for Male Impotence:
Aggregate Net Sales: % Royalty
First $100,000,000 6%
Second $100,000,000 5%
Third $100,000,000 4%
Excess Over $300,000,000 3%
Under certain terms of the Impotence Agreement the above royalty percentages
may be reduced by two percentage points for sales in countries where patent
protection is unavailable or deemed ineffective. There can be no guarantee
concerning the Oral Treatment that FDA approvals will be secured and if secured
that Zonagen will be successful in marketing of the product.
In the year ended February 1995 the Company recorded licensing income from the
Impotence Agreement of $47,107 ($100,000 in payments made by Zonagen less
related expenses of $52,893). In the year ended February 1996 no payments were
received by Gamogen under the Impotence Agreement.
On May 28, 1996 a stock payment was received by Gamogen in the form of 19,512
restricted common stock shares of Zonagen in accordance with the terms of the
Impotence Agreement. The number of shares was
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computed by dividing $200,000 by the NASDAQ closing price on April 12, 1996 of
$10.25 per share. In accordance with the terms of the Impotence Agreement, the
19,512 shares are restricted and bear the appropriate legend. Considering the
generally limited market for restricted shares, the Rule 144 holding period of
a minimum of two years, and the historical variance in the market prices for
Zonagen stock, Gamogen initially valued these shares at 50% of the stock price
on April 12, 1996 or $100,000. Gamogen valued these shares understanding that
the future valuation of these shares may be changed to reflect the length of
the holding period, changes in the current market price of Zonagen common
stock, or other factors which in the opinion of management may affect the value
of these securities. On June 10, 1996 Gamogen received an offer of $4.50 per
share, a total of $87,800, on the 19,512 restricted shares from a small group
of private investors. This price was approximately 50% of the then NASDAQ
market price for Zonagen, Inc. common stock. On June 20, 1996 Gamogen sold the
19,512 restricted shares to the same group of private investors for $87,800.
On January 24, 1997 the Board of Directors Gamogen approved and signed with
Zonagen a conditional amendment to the Impotence Agreement granting Zonagen the
right ("Option") to amend the Impotence Agreement eliminating the following:
1) Gamogen's rights to royalties on Zonagen's future sales of the Oral
Treatment;
2) Gamogen's rights to market the Oral Treatment in counties where Zonagen does
not timely obtain regulatory approval for and commence marketing of the Oral
Treatment.
The Option is conditioned on the payment to Gamogen of one of the following
amounts ("Option Price") less any Maintenance Payments (see below) received by
Gamogen pursuant to the conditional amendment:
(i) if the Option is exercised on or before January 24, 1998, $750,000;
(ii) if the Option is exercised after January 24, 1998 but on or before
January 24, 1999, $1,000,000;
(iii) if the Option is exercised after January 24, 1999 but on or before
July 24, 1999, $1,500,000;
(iv) if the Option is exercised after July 24, 1999 but before the expiration
of the Option, $1,750, 000.
Under the conditional amendment Zonagen is granted the option for a period of
three years ending January 24, 2000, however, Gamogen may terminate the Option
prior to January 24, 2000 if Zonagen fails to make any of the following
payments ("Maintenance Payments") in cash to Gamogen: $75,000 upon the
execution of the conditional amendment and $75,000 on each July 24 and January
24 which occurs after the execution of the conditional amendment and before
Zonagen's exercise of the Option, with the final payment due on July 24, 1999.
On January 24, 1997 Gamogen received from Zonagen the initial Maintenance
Payment of $75,000. As a result of the sale on June 20, 1996 of the 19,512
restricted Zonagen shares for $87,800 and receipt of the initial maintenance
payment of $75,000 on January 24, 1997 Gamogen recorded licensing income of
$162,800 for the year ended February 1997.
On June 24, August 2 and November 30 1996 Zonagen issued press releases
concerning FDA and US patent approvals on its Vasomax product (the Oral
Treatment) which included the following:
"The Woodlands, Texas, June 24, 1996 - Zonagen, Inc. (NASDAQ: ZONA;
Pacific ZNG) announced today that it has received notification from the
United States Patent and Trademark Office that the patent covering the use
of VASOMAX(TM) as a treatment for erectile dysfunction (impotency) has
been allowed. The second, more recent application, is still pending.
Zonagen also announced that it has submitted the IND for VASOMAX(TM) to
the FDA as the first step in its US Phase III development program.
VASOMAX(TM) is currently in a pivotal Phase III trial in Mexico scheduled
to be completed in 1996. The Company has selected Pharmaco-LSR and
Affiliated Research Centers (ARC) for its US clinical development team and
clinical sites. Dr. Irwin Goldstein of Boston University Medical Center, a
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renowned researcher in the field of impotency therapy, has been appointed
as Scientific Advisor for the VASOMAX(TM) program and Dr. David Ferguson,
Senior Vice President, Affiliated Research Centers, will act as special
consultant during the Phase III trials."
"The Woodlands, Texas, August 2, 1996 - Zonagen, Inc. (NASDAQ: ZONA;
Pacific ZNG) today has announced it has begun its U.S. pivotal clinical
trials of VASOMAX (TM), the Company's "on-demand" oral therapeutic for
male impotency. Based in part by what it considers to be encouraging early
data from its Mexican study, the Company has decided to accelerate its
U.S. clinical program. VASOMAX (TM) will be administered to patients this
week in the U.S. and the Company expects to begin pivotal studies by late
August. The Company plans to complete the Phase III portion of the trials
by the first quarter of 1997 and submit an NDA to the FDA by June of 1997.
Joseph S. Podolski, President and CEO said, `The continued clinical
success of VASOMAX(TM) confirms our belief that it may provide a
cost-effective, user-friendly therapy for approximately 40-50% of all
impotent men. Particular attention has been placed on both side effect
profiles and the ability to restore sufficient erectile function to
achieve orgasm on every sexual attempt. The interim analysis of the
Mexican data shows the drug to be well tolerated, with no incidence of
hypotension or fainting. Furthermore, the number of men who were able to
achieve orgasm using VASOMAX(TM) was consistent with earlier pre-clinical
and clinical human studies.'
The Company's Board of Directors made a decision on July 31, 1996 to
accelerate the clinical development of VASOMAX(TM). As a result of this
accelerated U.S. clinical plan, the Company will require additional funds
in the beginning of the fourth quarter of 1996."
"The Woodlands, Texas, November 30, 1996 - ZONAGEN, INC. (Nasdaq: ZONA)
announced today that it completed an initial closing of a private
placement in which the Company sold 1.14 million shares of
newly-authorized Series B Convertible Preferred Stock at a price of $10.00
per share representing gross proceeds of $11.4 million. Each share of the
Company's Series B Convertible Preferred Stock is initially convertible
into approximately 1.51 shares of Common Stock. The conversion price is
subject to adjustment in certain circumstances."
As of May 19, 1997 Zonagen had not received approval by the US FDA or approvals
in other countries for the marketing of Vasomax (the Oral Treatment). There can
be no guarantee concerning the Oral Treatment that approvals by the US FDA or
approvals in other countries will be secured and if secured that Zonagen will
be successful in marketing of the product. As of May 19, 1997 Gamogen has not
received any royalty payments under the Impotence Agreement. Based on the above
press releases by Zonagen, Gamogen does not anticipate royalty payments under
the Impotence Agreement from Zonagen within the next 12 months, with the
exception, subject to the Option, of possible royalty payments by Zonagen
resulting from the sale of the Oral Treatment in Mexico. Although there can be
no guarantee concerning Maintenance Payments under the Option, Gamogen does
anticipate Maintenance Payments from Zonagen of $150,000 within the next 12
months.
Repro-Med, the controlling shareholder of the Company, owns 58.3% of the
Company's Common Stock. Repro-Med, a public corporation, was organized in 1980
and is currently manufacturing and marketing medical devices for the treatment
of male infertility, male impotence, emergency airway management, and
intravenous infusion. Repro-Med's President and Chairman and controlling
shareholder is Andrew I. Sealfon. Mr. Sealfon also serves as Chairman of the
Board and President of the Company.
Company Products
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Gynecological Products
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On May 27, 1987, the Company acquired the gynecological products of Lukens
Corporation-New Jersey for a cash purchase price of $550,000. The acquisition
included the proprietary rights to several gynecological products including the
Masterson Endometrial Biopsy System, the Gyneco Thermal Cautery System for
tubal ligation and certain manufacturing equipment and inventory related to
these products. The Company transferred the assets acquired to its wholly-owned
subsidiary, Gyneco, Inc.
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The Masterson Endometrial Biopsy System is a device for performing in-office
biopsy sampling procedures. The Masterson Endometrial Biopsy System can provide
essential tissue samples for diagnosis of infertility, menstrual disorders,
bleeding, hormonal therapy, and screening for abnormal cytology. The system is
composed of a non-electric vacuum pump which is easily operated with one hand
and sterile individual procedure trays containing a sized metal curette,
fixative cup, cap and label.
The Gyneco Thermal Cautery System was designed to provide a safe, reliable and
effective method for female sterilization. The Gyneco Thermal Cautery Unit
provides low voltage coagulation via a rechargeable battery. In using the
Gyneco Thermal Cautery System, the fallopian tube is retracted by use of a wire
hook into a Teflon shield for safe coagulation and transsection during the
procedure. The acceptance of tubal sterilization has been greatly influenced by
the refinements of instrumentation and techniques after the introduction of
laparoscopy. The endoscopic approach to sterilization constitutes a simple,
safe and effective technique that can be used without prolonged
hospitalization. Research efforts in the field of female sterilization have
focused on methods that provide simplicity, safety and effectiveness. The
Gyneco Thermal Cautery System seems to meet most of these criteria.
Other Gyneco Products include: Gyneloop Stirrups, which fit various operating
tables and are shaped for better patient access and Gyneco fetal monitor
recording paper, leg, and abdominal belts.
Impotency Products
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Oral Treatment for Male Impotence
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On July 10, 1993, the Company acquired the rights to an Oral Treatment for Male
Impotence developed by Dr. Zorgniotti. On April 12, 1994 the Board of Directors
of Gamogen approved and on April 14, 1994 Gamogen signed with Zonagen the
Impotence Agreement (see "History of the Company" above) under which Zonagen
acquired all rights of Gamogen to the Oral Treatment. In exchange for the above
rights Gamogen received from Zonagen $100,000 in cash and 19,512 shares of
restricted common stock of Zonagen and rights to royalties on Zonagen's future
sales of the Oral Treatment. On June 20, 1996 Gamogen sold the restricted
common stock received from Zonagen to a small group of private investors for
$87,800.
On January 24, 1997 Gamogen signed with Zonagen a conditional amendment to the
Impotence Agreement granting Zonagen an Option to amend the Impotence Agreement
(see "History of the Company" above) eliminating the following:
1) Gamogen's rights to royalties on Zonagen's future sales of the Oral
Treatment;
2) Gamogen's rights to market the Oral Treatment in counties where Zonagen does
not timely obtain regulatory approval for and commence marketing of the Oral
Treatment.
The Option is conditioned on the payment to Gamogen of one of the following
amounts ("Option Price") less any Maintenance Payments (see "History of the
Company" above) received by Gamogen pursuant to the conditional amendment:
(i) if the Option is exercised on or before January 24, 1998, $750,000;
(ii) if the Option is exercised after January 24, 1998 but on or before
January 24, 1999, $1,000,000;
(iii) if the Option is exercised after January 24, 1999 but on or before
July 24, 1999, $1,500,000;
(iv) if the Option is exercised after July 24, 1999 but before the expiration
of the Option, $1,750, 000.
Under the conditional amendment Zonagen is granted the option for a period of
three years ending January 24, 2000, however, Gamogen may terminate the Option
prior to January 24, 2000 if Zonagen fails to pay Gamogen
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Maintenance Payments of $75,000 semi-annually beginning on January 24, 1997. On
January 24, 1997 Gamogen received from Zonagen the initial Maintenance Payment
of $75,000. As a result of the sale on June 20, 1996 of the 19,512 restricted
Zonagen shares for $87,800 and receipt of the initial maintenance payment of
$75,000 on January 24, 1997 Gamogen recorded licensing income of $162,800 for
the year ended February 1997. In the year ended February 1996 no payments were
received by Gamogen under the Impotence Agreement. In the year ended February
1995 the Company recorded licensing income from the Impotence Agreement of
$47,107 ($100,000 in payments made by Zonagen less related expenses of
$52,893).
As of May 19, 1997 Gamogen has not received any royalty payments under the
Impotence Agreement. Based on certain press releases by Zonagen (see "History
of the Company" above), Gamogen does not anticipate royalty payments under the
Impotence Agreement from Zonagen within the next 12 months, with the exception,
subject to the Option, of possible royalty payments by Zonagen resulting from
the sale of the Oral Treatment in Mexico. Gamogen does anticipate Maintenance
Payments of $150,000 within the next 12 months under the Option. As of May 19,
1997 Zonagen had not received approval by the US FDA or approvals in other
countries for the marketing of the product. There can be no guarantee
concerning the Oral Treatment that approvals by the US FDA or approvals in
other countries will be secured and if secured that Zonagen will be successful
in marketing of the product.
Injectable Drug Combination Treatment System
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The Company's injectable drug combination combines specific quantities of two
prescription drugs which are currently labeled for other indications,
papaverine hydrochloride and phentolamine mesylate. The drug combination was
tested in over 300 patients by Dr. Zorgniotti between 1984 and 1993 and had
been successful in approximately 80% of the cases. Observed side effects of the
drug combination consists of pharmacological reversible prolonged erection and
development of fibrotic changes of the corpus cavernosum which do not appear to
interfere with the function of the drug but could impair the ability to insert
a prosthesis at a future date. Papaverine hydrochloride alone is now being used
in the treatment of impotence by some physicians.
The Company signed an agreement in January 1988 granting Humagen, Inc.
("Humagen") the exclusive right to market Gamogen's injectable impotence
product in the United States. On August 21, 1989, Humagen and Gamogen
terminated this agreement subject to Humagen's rights to certain royalties on
the future sales of the Company's Injectable Drug Combination Treatment.
Management believes that the Company's injectable drug combination has some
commercial potential, however, due to the significant direct investment
required, the Company has suspended spending on this program. The Company has
not been successful in securing a new partner to continue the development of
the injectable drug combination. There can be no assurance that a new partner
will be secured or if secured that a new partner would be successful in
commercializing the product.
Since spending on the injectable drug combination product has been suspended,
the Company has discontinued development of its two accessory products: the
drug intermixing delivery system and the implantable dispensing prosthesis,
including discontinuing support of their related patents.
Patents
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On May 27, 1987, the Company purchased certain rights to a number of United
States patents and trademarks from Lukens Corporation related to the Gyneco
products as follows: Patent Nos. 3,982,742 for Medical Stirrups and 3,982,542
for Electroresectroscope and Method of Laparoscopic Tubal Sterilization both
issued September 28, 1976, 3,885,590 for a Gas Transmission and Monitoring
Device issued May 27, 1975, and Design Patent Nos. 271,521 for Pump Handle for
use with a Biopsy Specimen Collector issued November 22, 1983, and
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4,257,425 for Biopsy Specimen Collector issued March 24, 1981. The United
States trademarks purchased are GYNECO, GYNECYTE, GYNELOOP, MASTERSON,
CARBOFLATOR.
The Company had conducted limited research into a device for amniocentesis to
improve the sensitivity of the assay. The device was designed to permit
amniocentesis, a process by which the genetic disposition of a fetus is
determined, to be obtained at a much earlier stage in a pregnancy. The US
Patent Office issued Patent Number 5,000,192 for a Prenatal Specimen Collection
Method on March 19,1991.
The patent position of companies such as Gamogen generally is highly uncertain
and involves complex legal and factual questions. Accordingly, there can be no
assurance that patent applications relating to the Company's products or
technology will result in patents being issued or that, if issued, the patents
will afford protection against competitors with similar technology. Moreover,
some patent licenses held may be terminated upon the occurrence of certain
events or become non-exclusive after a specified period. There can be no
assurance that the Company will have the financial resources necessary to
enforce any patent rights it may hold.
Government Regulation
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The development, testing, production and marketing of the Company's products
are subject to regulation by the FDA and the New York State Department of
Health, and may be subject to further FDA regulation as devices under 1976
Medical Device Amendments to the Federal Food, Drug and Cosmetic Act.
Additionally, the Company's products may be subject to regulation by similar
agencies in other states and foreign countries. All the Company's currently
marketed products have received the necessary FDA approvals for marketing in
the US. The FDA reviews all devices regulated within its domain, and may
require additional testing, clinical trials, or create other regulatory action
which may adversely affect the Company's ability to market its medical
products. One of the Company's gynecological products, the Thermal Cautery
System, was approved by a grandfather provision of the FDA regulations having
been in use prior to the Device Act of 1976, and therefore may at the FDA's
direction require recertification under the Pre-Market Approval Application
(PMA) to permit continued marketing. The FDA's PMA process may be costly and
may not be cost effective when applied to products with limited market share
and annual revenues.
Marketing
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Sales of the Masterson Biopsy System decreased $10,381 or 12% in the year due
to continued erosion of the market for this device in the US due to competition
from more convenient lower cost devices. Sales of the Thermal Cautery System
products decreased by $33,889 in the year due primarily to increased
competition in the US from other devices. Other Gyneco products sales decreased
$4,006 or 17% in the current fiscal year. In the prior fiscal year the Company
initiated an advertising effort to introduce its products outside the US. These
efforts continued in the current fiscal year. Various other marketing programs
for the Company's gynecological products are under investigation and may be
implemented as the Company's financial resources allow. There can be no
guarantee that these programs, if pursued, will prevent further erosion of
sales in the US nor increase sales over present levels.
Although no individual customer, either physician, hospital or group of
hospitals under common control accounts for a significant portion of sales of
gynecological products, one hospital group accounted for 10% of sales of such
products for the fiscal year ended February 28, 1997 and 9% for the fiscal year
ended February 29, 1996.
Manufacturing
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The Company and its subsidiary, Gyneco assemble and test the products at a
facility in Chester, NY which is owned by Repro-Med. Gyneco purchases the parts
required to manufacture its gynecological products from various vendors. The
Company believes that it obtains a better price by purchasing certain parts
from a single
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vendor. Certain injection molded parts are produced with tooling
owned by the Company, which believes that it could locate an alternate source
of supply by transferring the tooling to one of numerous injection molding
vendors. Raw materials for molding of the Company's gynecological products are
available from multiple sources at competitive prices. The Company currently
assembles its disposables and sends them to an outside contractor for
sterilization.
Research & Development
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Due to limited financial resources, the Company curtailed research and
development and patent approval work on its Impotence Drug Combination. The
Company continues to seek a partner for the further development and marketing
of this product. Future research efforts by the Company are subject to
availability of funds from non-operating sources and subject to non-compete
requirements of the agreement with Zonagen.
Agreements with Repro-Med
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The Company has agreements with Repro-Med for the lease of manufacturing,
warehouse and office space at Repro-Med's Chester, NY facility and
reimbursement of payroll and other operating expenses based on actual payroll
allocations, occupancy and equipment utilization.
For the fiscal year ended February 28, 1997, on a combined basis, the Company
and it's subsidiary Gyneco paid Repro-Med facility lease payments of $12,528.
The Company's subsidiary Gyneco has an agreement with Repro-Med for the use of
certain tooling owned by Gyneco (see item 12). Under this agreement Repro-Med
paid to Gyneco $62,776 in the fiscal year ended February 1997
Hourly and management compensation costs are paid by Repro-Med and allocated to
Gamogen and Gyneco based agreements for the reimbursement of operating
expenses. Salary and payroll related costs are allocated based on individual
employee time-card reporting. Executive salary and payroll related costs are
allocated based on estimates of time spent in the management of the three
companies. For the fiscal year ended February 1997, on total salary costs of
$923,196, these allocations averaged as follows: Repro-Med 74%, Gyneco 24%, and
Gamogen 2%. This compares to total salary costs of $990,649 for the fiscal year
ended February 1996 which were allocated as follows: Repro-Med 74%, Gyneco 24%,
and Gamogen 2%. Incentive bonuses are paid based on a percentage of
consolidated income before taxes for management and direct employees and on a
percentage of consolidated income after tax for executives. Bonuses paid by
Repro-Med for the fiscal years ended February 1997 and 1996 were $18,800 and
$32,670, respectively. For the fiscal years ended February 1997 and 1996 the
incentive bonuses were fully allocated to Repro-Med and due to minimal earnings
in 1997 and operating losses in 1996 no portion of the bonus payments were
allocated to Gamogen or Gyneco.
Product Liability Insurance
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The Company could be exposed to possible claims for personal injury resulting
from the sale of allegedly defective gynecological products. The Company has
obtained product liability insurance in an amount customary in the medical
device industry for its gynecological products. However, there is no assurance
that this insurance will be sufficient to cover judgments which might be
entered against the subsidiary.
Competition
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Endometrial biopsy is a fast, reliable, safe and simple physician-office based
procedure. It is felt to be a cost-effective alternative to dilation and
curettage (D&C) which, although reliable in diagnosing intrauterine
abnormalities, is typically performed in a hospital operating-room setting
utilizing general anesthesia.
Competitors to Gyneco's Masterson Biopsy System for endometrial biopsy include
the following disposable single-patient devices: Pipelle Vacuum Curette, Vabra
Aspirator, and Tis-U-Trap system. Some physicians
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continue to use traditional stainless steel biopsy instruments which are
available from a number of manufacturers. Stainless steel biopsy instruments
are much less convenient but can be sterilized and reused many times.
Imported from France, the Pipelle is a very inexpensive device combining a
flexible plastic tube 3mm in diameter with a small port near the tip. After
inserting the device, suction is generated by manually withdrawing a locking
plunger. As the plunger is withdrawn a sample column of tissue is suctioned
into the tube. The tube is then withdrawn. Due to it's low cost and convenience
the Pipelle is the leading device for use in outpatient endometrial biopsy
procedures. Numerous devices similar to the Pipelle, including the Z-Sampler,
are also available in the marketplace at prices competitive with the Pipelle.
The Vabra Aspirator and Tis-U-Trap, similar to the Masterson, are ideal when
the physician needs larger specimen samples. Both feature plastic cannula and a
tissue collection chamber but require an external source of suction, typically
a portable electric vacuum pump.
The Gyneco Thermal Cautery System provides a simple, quick, and effective
transection and coagulation of the fallopian tubes. There are three main
surgical device systems which compete with Gyneco's Thermal Cautery System. The
first of these are bipolar cauterization systems, which include a generator and
reusable forceps, and can be acquired from a number of manufacturers. Bipolar
cauterization systems accomplish transection and electrocoagulation through the
use of alternating current arcing to heat and destroy tissue. These systems are
also used in surgery on a routine basis for the elimination of tissue. The
remaining two device systems use mechanical occlusion to effect a tubal
sterilization. Mechanical Occlusion tubal sterilization involves permanently
attaching a number of small mechanical devices using a specialized forceps-like
instrument to occlude portions of each fallopian tube. The two systems are the
Hulka Clip and the Yoon Falope Ring. The Hulka Clip consists of a plastic clamp
and fastening spring. Use of the Hulka Clip requires specialty forceps called a
"clip applicator" and a number of the single-use Hulka Clips. The Hulka Clip is
marketed by Richard Wolf Medical Devices Corporation, Vernon Hills, IL. The
Yoons Falope Ring method consists of a silicone rubber ring which is applied to
a "loop" formed from the fallopian tube. Similar to the Hulka Clip, use of the
Yoons Falope Ring requires a specialty forceps-like applicator. The Yoon Falope
Ring system is marketed by Cabot Medical Corporation, Langhorne, PA.
Employee Incentive Stock Option Plan
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The Company's Board of Directors and shareholders have approved an Incentive
Stock Option Plan ("the Plan"). The Plan authorizes the granting to key
employees of options to purchase an aggregate of 40,000 shares of the Company's
Common Stock at an option price of not less than the fair market value on the
date of the grant. To date no options have been granted under the Plan.
Employees
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There are no employees working solely for the Company. The Company has an
agreement with Repro-Med for the reimbursement of operating expenses which is
based on actual payroll allocations, occupancy and equipment utilization (see
"Agreements with Repro-Med").
Repro-Med has 28 employees as of February 28, 1997.
Item 2. Properties
- ------- ----------
The Company has agreements with Repro-Med for the lease of manufacturing,
warehouse and office space at Repro-Med's Chester, NY facility and
reimbursement of payroll and other operating expenses based on actual payroll
allocations, occupancy and equipment utilization. For the fiscal year ended
February 28, 1997, on a combined basis, the Company and it's subsidiary Gyneco
paid Repro-Med facility lease payments of $12,528.
9
<PAGE>
Item 3. Legal Proceedings
- ------- -----------------
The Company is not a party to any material litigation, nor to the knowledge of
the officers and directors of the Company, is there any material litigation
threatened against the Company.
Item 4. Submission of Matters to a Vote of Security Holders
- ------- ---------------------------------------------------
No matters were submitted to a vote of security holders of the Company during
the last quarter of the fiscal year ended February 28, 1997.
Part II
- -------
Item 5. Market for the Registrant's Common Equity and Related
- ------- -----------------------------------------------------
Shareholder Matters
-------------------
The Company is authorized to issue 4,000,000 shares of Common Stock,
$.01 par value, of which 1,230,000 shares were issued and outstanding as of
February 28, 1997. At December 15, 1989, the Company's Common Stock was held by
approximately 164 beneficial holders.
From December 4, 1986, to March 29, 1987, the Company's stock was traded
over-the-counter. From March 30, 1987, through April 12, l988, the Company's
Units were listed on NASDAQ under the symbol "GAMOU". Starting April 13, 1988,
the Company's Common Stock was listed on NASDAQ under the symbol "GAMO" and its
warrants were listed under the symbol "GAMOU". As of June 1, 1990 the Company
was unable to continue its listing on NASDAQ and may be traded on the "pink
sheets" in the over the counter market.
To the best of Management's knowledge there has been no trading or bid activity
in Gamogen securities for the fiscal years ended February 1993, 1994, 1995, and
1996.
The Company's Common Stock is traded in the over-the-counter market and was
quoted through the National Daily Quotation Service. The following table sets
forth the high and low closing bid quotations for the Company's Common Stock as
reported by the National Quotation Bureau, Inc. for the periods indicated.
These quotations represent bid prices between dealers, do not include retail
mark-ups, mark-downs or commissions and do not necessarily represent actual
transactions.
High Bid Low Bid
-------- -------
Fiscal Year Ending
- ------------------
February 28, 1997:
- ------------------
1st Quarter $0.03 $0.03
2nd Quarter $0.03 $0.03
3rd Quarter $0.03 $0.03
4th Quarter $0.03 $0.03
Fiscal Year Ending
- ------------------
February 28, 1998:
- ------------------
3/1/97 - 5/15/97 $0.03 $0.03
The Company has not declared or paid any cash dividends on its Common Stock and
does not anticipate that any dividends will be paid in the foreseeable future.
10
<PAGE>
Item 6. Management's Discussion and Analysis of Financial Condition and
- ------- ---------------------------------------------------------------
Results of Operations
---------------------
Liquidity and Capital Resources
- -------------------------------
The Company completed its initial public offering in December 1986 from which
it received net proceeds of approximately $1,656,000. The Company spent $75,000
of the net proceeds of the offering in the period between December 8, 1986 and
the end of the fiscal year on February 28, 1987, and approximately $319,000
during the fiscal year ended February 1988, in connection with research,
development, and regulatory approval efforts for the Company's impotence
products and other administrative expenses. During the year ended February
1989, the Company applied the remainder of such proceeds on the acquisition for
$550,000 of certain assets of Gyneco, research, development, and regulatory
approval efforts for the Company's impotence products and other administrative
expenses.
At February 28, 1997, the Company had cash and equivalents on a consolidated
basis of $1,368 and had a net working capital of $121,703. Working capital
increased $21,578 versus the balance at February 29, 1996. The increase in
working capital was due primarily to a decrease in other liabilities offset in
part by a decrease in accounts receivable and inventory resulting from lower
sales.
The Company attempts to maintain sufficient inventory to enable it to promptly
satisfy all customer orders out of existing inventory. The Company sells its
products to US and foreign distributors, US hospitals, and private physicians.
Sales to US distributors, hospitals, and private physicians are mainly on 30
day net payment terms. A variety of payment terms are employed for export sales
including cash prepayments, irrevocable letters of credit, and 45 day net
payment. As of February 28, 1997, 2% of accounts receivable were over 60 days,
5% were at 30-59 days and 93% were current.
On July 10, 1993, the Company acquired the rights to an Oral Treatment for Male
Impotence developed by Dr. Zorgniotti. On April 12, 1994 the Board of Directors
of Gamogen approved and on April 14, 1994 Gamogen signed with Zonagen the
Impotence Agreement (see "History of the Company" above) under which Zonagen
acquired all rights of Gamogen to the Oral Treatment. In exchange for the above
rights Gamogen received from Zonagen $100,000 in cash and 19,512 shares of
restricted common stock of Zonagen and rights to royalties on Zonagen's future
sales of the Oral Treatment. On June 20, 1996 Gamogen sold the restricted
common stock received from Zonagen to a small group of private investors for
$87,800.
On January 24, 1997 Gamogen signed with Zonagen a conditional amendment to the
Impotence Agreement granting Zonagen an Option to amend the Impotence Agreement
(see "History of the Company" above) eliminating the following:
1) Gamogen's rights to royalties on Zonagen's future sales of the Oral
Treatment;
2) Gamogen's rights to market the Oral Treatment in counties where Zonagen does
not timely obtain regulatory approval for and commence marketing of the Oral
Treatment.
The Option is conditioned on the payment to Gamogen of one of the following
amounts ("Option Price") less any Maintenance Payments (see "History of the
Company" above) received by Gamogen pursuant to the conditional amendment:
(i) if the Option is exercised on or before January 24, 1998, $750,000;
(ii) if the Option is exercised after January 24, 1998 but on or before
January 24, 1999, $1,000,000;
(iii) if the Option is exercised after January 24, 1999 but on or before
July 24, 1999, $1,500,000;
(iv) if the Option is exercised after July 24, 1999 but before the expiration
of the Option, $1,750, 000.
11
<PAGE>
Under the conditional amendment Zonagen is granted the option for a period of
three years ending January 24, 2000, however, Gamogen may terminate the Option
prior to January 24, 2000 if Zonagen fails to pay Gamogen Maintenance Payments
of $75,000 semi-annually beginning on January 24, 1997. On January 24, 1997
Gamogen received from Zonagen the initial Maintenance Payment of $75,000. As a
result of the sale on June 20, 1996 of the 19,512 restricted Zonagen shares for
$87,800 and receipt of the initial maintenance payment of $75,000 on January
24, 1997 Gamogen recorded licensing income of $162,800 for the year ended
February 1997. In the year ended February 1996 no payments were received by
Gamogen under the Impotence Agreement. In the year ended February 1995 the
Company recorded licensing income from the Impotence Agreement of $47,107
($100,000 in payments made by Zonagen less related expenses of $52,893).
As of May 19, 1997 Gamogen has not received any royalty payments under the
Impotence Agreement. Based on certain press releases by Zonagen (see "History
of the Company" above), Gamogen does not anticipate royalty payments under the
Impotence Agreement from Zonagen within the next 12 months, with the exception,
subject to the Option, of possible royalty payments by Zonagen resulting from
the sale of the Oral Treatment in Mexico. Gamogen does anticipate Maintenance
Payments of $150,000 within the next 12 months under the Option. As of May 19,
1997 Zonagen had not received approval by the US FDA or approvals in other
countries for the marketing of the product. There can be no guarantee
concerning the Oral Treatment that approvals by the US FDA or approvals in
other countries will be secured and if secured that Zonagen will be successful
in marketing of the product.
The Company derived a significant portion of its funds for continuing operation
as a result of loan advances from an affiliate. As of February 1997 outstanding
net loan advances from the affiliate are $66,314 and are included in Other
Current Liabilities. Under terms of an agreement with its affiliate to extend
repayment terms on this advance balance, the net loan advance of $66,314 is due
on March 1, 1998. Under terms of the extension Gamogen will pay its affiliate
an additional $5,968 in interest on this advance on March 1, 1998. If Gamogen
pays the advance in whole or in part earlier than March 1, 1998 then the
interest amount will be prorated accordingly at an APR of 9%. Gamogen's
anticipated cash flow from operations, including Maintenance Payments of
$150,000 under the Impotence Agreement Option (see above) is expected to be
sufficient to enable it to meet its total net cash requirements through
February 1998, however, the Company anticipates that it will continue to rely
on loan advances from an affiliate to fund periodic cash shortfalls due to
payments required by its vendors under standard trade terms. There can be no
guarantee, however, that loan advances from the Company's affiliate will
continue to be made nor that extensions beyond March 1, 1998 for full payment
of the amount of $66,314 plus related interest of $5,968 will be made.
In an effort to improve its cash flows from operations, the Company has
curtailed research and development in favor of efforts to improve sales of
current products and reduce expenses. There can be no guarantee that
obligations beyond February 1998 can be met from current projected cash flow.
As previously reported, the Company, in consideration of the above items, is
investigating other options to improve its projected cash flow and liquidity.
Under investigation are the issuance of additional common stock and the sale of
the Company's Gyneco subsidiary.
Any statements which are not historical facts contained in this report are
forward looking statements that involve risks and uncertainties, including but
not limited to those relating to the uncertainty related to the Company's
affiliate continuing to make loan advances to the Company or to grant an
extension beyond March 1, 1998 for full payment of the amount owed of $66,314
if unpaid, Zonagen's inability or refusal to pay the Maintenance Payments,
Zonagen's exercise of the Option, approval of, sale of or royalties earned from
the Oral Treatment, other unexpected increases or decreases in sales of the
Company's products, and uncertainty related to Food and
12
<PAGE>
Drug Administration or other government regulation, and other risks identified
in the Company's Securities and Exchange Commission filings.
Results of Operations
- ---------------------
Fiscal 1997 Compared To Fiscal 1996:
- ------------------------------------
Sales were $343,675 in the fiscal year ended February 28, 1997 a decrease of
$50,792 or 13% as compared with sales of $394,467 in fiscal 1996. The sales
decrease was due primarily to decreased sales of the Masterson Biopsy System
and Thermal Cautery System. Selling, general, and administrative expenses were
$330,334 in the current fiscal year as compared with $325,437 in the previous
fiscal year. Depreciation and amortization expense decreased from $14,216 in
the previous fiscal year to $13,753 in the current year. There were no
expenditures for research and development in the current fiscal year.
Due to increased operating losses by the Company's subsidiary, Gyneco, Inc.,
the Company's loss from operations of $148,794 in the fiscal year ended
February 28, 1997 increased versus the loss from operations of $111,800 in the
previous fiscal year. The Company's loss from operations in the fiscal year
ended February 28, 1997 includes Gyneco's loss from operations of $97,587. In
the fiscal year ended February 29, 1996 the Company's loss from operations
included a loss from operations by Gyneco of $62,570.
Due to licensing income of $162,800 (see "Liquidity and Capital Resources"
section above) the Company's net profit for the fiscal year ended February 28,
1997 was $7,825. This compares to the Company's net loss for the fiscal year
ended February 29, 1996 of $111,278.
The net income per share of common stock is $0.01 for the fiscal year ended
February 28, 1997 and compares to a net loss per share of $0.09 in the prior
fiscal year.
Fiscal 1996 Compared To Fiscal 1995:
- ------------------------------------
Sales were $394,467 in the fiscal year ended February 29, 1996 increasing
$20,570 or 6% as compared with sales of $373,897 in fiscal 1995. Selling,
general, and administrative expenses were $325,437 in the current fiscal year
as compared with $253,899 in the previous fiscal year. Depreciation and
amortization expense decreased from $15,257 in the previous fiscal year to
$14,216 in the current year. There were no expenditures for research and
development expenditures in the current fiscal year. The Company's loss from
operations of $111,800 in the fiscal year ended February 29, 1996 increased
versus the loss from operations of $43,900 in the previous fiscal year due
primarily to operating losses by the Company's subsidiary, Gyneco, Inc. The
Company's loss from operations in the fiscal year ended February 29, 1996
includes Gyneco's loss from operations of $62,570. In the fiscal year ended
February 28, 1995 the Company's loss from operations included a loss from
operations by Gyneco of $2,830.
The Company's net loss for the fiscal year ended February 29, 1996 was
$111,278. This compares to the Company's net loss for the fiscal year ended
February 28, 1995 of $30,728, which included licensing income of $47,107 from
the sale of certain of the Company's impotence and a Loss On Termination Of
Building Lease of $35,609. The net loss per share of common stock is $0.09 for
the fiscal year ended February 29, 1996 and compares to a net loss per share of
$0.02 in the prior fiscal year.
Fiscal 1995 Compared To Fiscal 1994:
- ------------------------------------
Sales were $373,897 in the fiscal year ended February 28, 1995 declining
$13,439 or 3% as compared with sales of $387,336 in fiscal 1994. Selling,
general, and administrative expenses were $253,899 in the fiscal year ended
February 1995 as compared with $286,989 in the previous fiscal year.
Depreciation and amortization expense
13
<PAGE>
increased slightly from $15,194 in the previous fiscal year to $15,257 in the
fiscal year ended February 1995. There were no expenditures for research and
development expenditures in the fiscal year ended February 1995 as compared
$5,477 in the prior fiscal year. The Company's net loss from operations of
$43,900 for the fiscal year ended February 1995 was less than the loss from
operations of $95,889 for the previous fiscal year.
The Company's net loss for the fiscal year ended February 1995 was $30,728 as
compared to a net loss of $95,182 in the prior fiscal year and improved versus
the prior fiscal year primarily as a result of the reduction in its net loss
from operations and licensing income of $47,107 from the Impotence Agreement
(see Capital Resources and Liquidity section above). These improvements were
offset in part by a Loss On Termination Of Building Lease of $35,609. The
Company's net losses included the net losses of its subsidiary Gyneco which
were $2,830 in the fiscal year ended February 1995 and $41,968 in the prior
fiscal year. The Company had a net loss per share of $0.02 per share in the
fiscal year ended February 1995 versus a net loss per share of $0.08 in the
fiscal year ended February 1994.
Item 7. Financial Statements and Supplementary Data
- ------- -------------------------------------------
This information appears in a separate section of this report following Part
IV. Selected Financial Data.
<TABLE>
<CAPTION>
Selected Income Statement Data
------------------------------
Year Ended February
-------------------
1993 1994 1995 1996 1997
---- ---- ---- ---- ----
<S> <C> <C> <C> <C> <C>
Sales $418,313 $387,336 $373,897 $394,467 $343,675
Costs and Expenses 507,023 483,225 417,797 506,267 492,469
Interest & Other Income 0 707 13,172 522 163,896
Net Income (Loss) (88,710) (95,182) (30,728) (111,278) 7,825
Net Income (Loss) Per $(0.07) $(0.08) $(0.02) $(0.09) $0.01
Share
Selected Balance Sheet Data
---------------------------
Year Ended February
-------------------
1993 1994 1995 1996 1997
---- ---- ---- ---- ----
Current Assets $ 209,690 $ 198,782 $ 223,458 $ 216,714 $198,485
Total Assets 579,480 466,806 449,074 428,114 396,132
Current Liabilities 30,767 13,275 26,271 116,589 76,782
Total Liabilities 30,767 13,275 26,271 116,589 76,782
Working Capital 178,923 185,507 197,187 100,125 121,703
Stockholders' Equity 548,713 453,531 422,803 311,525 319,350
</TABLE>
Item 8. Disagreements on Accounting and Financial Disclosure
- ------- ----------------------------------------------------
None
14
<PAGE>
PART III
- --------
Item 9. Directors and Executive Officers of the Registrant
- ------- --------------------------------------------------
The following table sets forth certain information with respect to the
Executive Officers and Directors:
<TABLE>
<CAPTION>
Name Age Positions (Held since) Address
---- --- ---------------------- -------
<S> <C> <C> <C>
Andrew I. Sealfon* 52 President (4/87) 23 Allison Drive
Treasurer (3/86) Monroe, NY, 10950
Chairman (7/94)
Director (3/86)
Chief Executive Officer (3/86)
Jesse A. Garringer 47 Executive VP (9/92) 35 Orchard Hill Vista
Secretary (8/93) Florida, NY 10921
Director (7/94)
Chief Financial Officer (1/95)
Dr. Paul Mark Baker 48 Director (7/94) 92 Irwin Ave
Middletown, NY 10940
</TABLE>
* Mr. Sealfon may be deemed to be a "parent" and "promoter", as those terms are
defined under the Securities Act of 1933, as amended, (the "Act") .
Andrew I. Sealfon has served as President and Director of Repro-Med since
March, 1980, and as Repro-Med's Treasurer since May, 1983. He has been
Treasurer of Gamogen since March, 1986, and President of Gamogen since April,
1987. Mr. Sealfon is an electrical engineer and inventor and has been granted
numerous United States patents on medical devices, fluid systems, and
electronic equipment. From 1971 to June 1981, Mr. Sealfon served as Vice
President and Chief Engineer of Ceco Systems, Inc., Glen Cove, New York. He was
employed as a member of the research staff of Riverside Research Institute from
1969 to 1971 and as a member of the technical staff of ITT Federal
Laboratories, Avionics Division from 1967 to 1969. Mr. Sealfon is a graduate of
Lafayette College.
Jesse A. Garringer was hired by the Company and Repro-Med in September 1992 to
the position of Executive Vice President, was elected Secretary of both
companies in August 1993, and was appointed to the Board of Directors of
Gamogen in July 1994. In his position as Executive Vice-President, Mr.
Garringer is responsible for marketing, financial, and general management of
Repro-Med and Gamogen's subsidiary Gyneco, and assists in the strategic and
financial management of Gamogen. Prior to accepting the position of Executive
Vice President Mr. Garringer served in the position of Vice President
Operations for Matrx Medical, Inc. Mr. Garringer held this position from July,
1988 until June, 1992. During the period July and August, 1992 Mr. Garringer
was employed completing certain private consulting projects. Mr. Garringer
helped co-found Matrx Medical, Inc. in a management buyout of two divisions of
Ohmeda in July 1988 and was a major shareholder until its purchase by a large
Canadian medical company in January 1992. Matrx Medical is a leading
manufacturer of medical equipment for the Emergency Medical, Dental and
Veterinary anesthesia markets. In his position, Mr. Garringer was responsible
for Matrx's manufacturing, quality, and distribution operations. Prior to the
buyout and establishment of Matrx Medical, Mr. Garringer held the position of
Business Manager of Emergency Care for Ohmeda and established Ohmeda's position
as a supplier to the Emergency Medical Market. In this position, Mr. Garringer
provided strategic, marketing, product and manufacturing management for the
Ohmeda's Emergency Care division. Mr. Garringer held this position from March,
1984 until July, 1988. Prior to this position, Mr.
15
<PAGE>
Garringer served in various financial and business planning positions for the
following companies: Ohmeda, Division of BOC Ltd., Carborundum Co. a division
of Standard Oil of Ohio, and Pratt & Lambert, Inc.. Mr. Garringer holds an
M.B.A in finance from Canisius College, graduated as an Advanced E.M.T. in the
state of NY, and has served on numerous medical standards committees and as a
delegate to the ISO committee on Medical Suction.
Dr. Paul Mark Baker was appointed to the Board of Directors of Repro-Med in May
1991 and to the Board of Directors of Gamogen in July 1994. Dr. Baker was
awarded his medical degree from Cornell University Medical College in 1975, is
a practicing pediatrician in Middletown, NY and is attending at the Department
of Pediatrics Horton Memorial Hospital and attending at New York
Hospital-Cornell Medical Center in New York City.
Item 10. Executive Compensation
- -------- ----------------------
Andrew I. Sealfon, President of the Company, received $164,219 in salary from
the Repro-Med (including amounts attributable to services to the Company and
Gyneco) during the fiscal year ended February 28, 1997 and earned an incentive
bonus of $5,800 from Repro-Med in fiscal 1997 which is deferred for payment
until June 1997. Under an agreement between the Company and Repro-Med for
reimbursement of operating expenses and payroll costs, 25% of Mr. Sealfon's
salary is allocated to the Company. The Company does not pay for any portion of
Mr. Sealfon's fiscal 1997 bonus. Mr. Sealfon has been granted incentive stock
options in Repro-Med under its 1995 Stock Option Plan.
Jesse A. Garringer, Executive Vice President and Secretary, received $138,108
in salary from Repro-Med (including an amount attributable to services to the
Company and Gyneco) and earned an incentive bonus of $4,350 from Repro-Med in
fiscal 1997 which is deferred for payment until June 1997. Mr. Garringer's
salary is paid by Repro-Med and charged to the Company and it's subsidiary on a
basis commensurate with a direct allocation of time. The Company does not pay
for any portion of Mr. Garringer's fiscal 1997 bonus. Mr. Garringer has been
granted incentive stock options in Repro-Med under its 1995 Stock Option Plan.
Officers of the Company are reimbursed for travel and other expenses incurred
on behalf of the Company. The Company does not have any pension or profit
sharing plan.
Summary Compensation Table:
- ---------------------------
(all figures are in dollars)
<TABLE>
<CAPTION>
Long-term Compensation
-------------------------------
Awards Payouts
Annual Compensation ---------------------- -------
Name and Principle ----------------------------- Restricted Options/ LTIP All Other
Position FYE Salary Bonus Other Stock Awards SARs Payouts Compensation
- ------------------ --- ------ ----- ----- ------------ -------- ------- ------------
<S> <C> <C> <C> <C> <C> <C> <C> <C>
Andrew I. Sealfon, 1997 164,219 5,800 11,926 0 0 0 0
President 1996 142,488 10,100 12,060 0 0 0 0
1995 103,553 53,280 11,631 0 0 0 0
Jesse A. Garringer, 1997 138,108 4,350 5,926 0 0 0 0
Executive Vice 1996 121,863 7,500 6,060 0 0 0 0
President 1995 92,665 39,960 5,635 0 0 0 0
</TABLE>
* Note, under an agreement between Repro-Med and Gamogen (see Item 1),
Executive salaries and all other payroll costs are allocated between
Repro-Med, Gamogen, and Gamogen's subsidiary, Gyneco, on the basis of
individual employee time reporting. The total percentages allocated
for the fiscal year ended February 1997 were as follows: for Gamogen 2%,
for Gyneco 24%, and for Repro-Med 74%.
16
<PAGE>
Item 11. Security Ownership of Certain Beneficial Owners and Management
- -------- --------------------------------------------------------------
The only voting security of the Company is its Common Stock, par value $.01 per
share. The following table sets forth certain information with respect to each
beneficial owner of 5% or more of the outstanding Common stock, each director
and for all officers and directors as a group:
Percent of Outstanding
Name and Address Shares owned Common Stock
- ---------------- ------------ ----------------------
Repro-Med Systems, Inc. (1) 699,200 (2) 58.3%
All officers and directors
as a group (3 persons) 699,200 (2) 58.3%
(1) Repro-Med and Mr. Sealfon May be deemed to be "parents" and "promoters" as
those terms are defined under the Securities Act of 1933, as amended, (the
"Act").
(2) Certain rules and regulations promulgated under the Act may deem the shares
owned by Repro-Med to be beneficially owned by Mr. Sealfon as principal
shareholder of Repro-Med and as Repro-Med's Chairman of the Board and
President.
Item 12. Certain Relationships and Related Transactions
- -------- ----------------------------------------------
In April, 1986, the Company issued 699,200 shares of Common Stock to Repro Med
for $41,779.
Repro-Med and Gamogen have a facility lease and expense sharing agreements (see
item 1).
To economize the Company's production, Repro-Med has designed some of its
needed components around parts which were used in its Gyneco operations.
Commencing in fiscal 1993, Repro-Med compensated Gyneco for the use of certain
tooling, and parts of its proprietary design patent for those items using such
parts on the following basis: on Repro-Med OEM sales, Gyneco is compensated
with a 3% royalty on those sales employing parts relating to Gyneco tooling
used to create such parts, on Repro-Med sales based on the Res-Q-Vac items
employing such tooling is compensated on the basis of a 4% royalty to Gyneco.
Payments to Gyneco from Repro-Med under this arrangement totaled $62,776 in the
fiscal year ended February 1997 and $62,973 in the prior fiscal year.
The foregoing transactions are believed by the Company to be on terms no less
favorable to the Company than those that could have been obtained from
unaffiliated third parties.
Part IV
- -------
<TABLE>
<CAPTION>
Item 13. Exhibits, Financial Statement Schedules and Reports on Form 8-K
- -------- ---------------------------------------------------------------
<S> <C>
(a) 1 and 2 The response to this portion is submitted in the index to Item 8 which
is submitted in a separate section following Part IV
3. Exhibits
3.* Articles of Incorporation and By-laws
4.** Form of Warrant Agreement between the Company and American Stock Transfer
Company.
17
<PAGE>
l0 Material Contracts
l0(1)* 1985 Stock Option Plan
l0(2)* Assignment Agreement between the Company and Repro-Med dated 9/26/86.
l0(3)* License Agreement between the Company and Repro-Med dated 9/26/86.
l0(4)1** Distribution Agreement between the Company, Repro-Med Systems, Inc. and
Humagen, Inc. dated 1/1/88.
l0(4)2*** Amendment to Distribution Agreement between the Company, Repro-Med Systems,
Inc. and Humagen, Inc. dated 3/28/89.
l0(4)3**** Amendment to terminate Distribution Agreement between the Company,
Repro Med Systems, Inc. and Humagen, Inc. dated 8/21/89.
l0(5)***** Assignment Agreement Among Zonagen, Inc., Gamogen, Inc. and
Dr. Adrian Zorgniotti dated 4/13/94.
10(5)2****** Conditional Amendment No. 1 To Assignment Agreement Between
Gamogen, Inc. and Zonagen, Inc.
22 Subsidiary of Registrant: Gyneco, Inc., a wholly owned NY Corporation.
(b) Reports on Form 8-K: A report dated January 24, 1997 on Form 8-K was filed
during the fourth quarter of the fiscal year ended February 28, 1997.
- ---------------------------------------------------------------------------
<FN>
* Incorporated by reference from the Form S-1 Registration Statement of Gamogen, Inc.,
dated Sep 30, 1986
** Incorporated by reference from Form 8-K Report of Gamogen, Inc. dated Feb 18, 1988.
*** Incorporated by reference from Form 10-K Report of Gamogen, Inc. dated Feb 28, 1989.
**** Incorporated by reference from Form 10-K Report of Gamogen, Inc. dated Feb 28, 1990.
***** Incorporated by reference from Form 10-K Report of Gamogen, Inc. dated Feb 28, 1994.
****** Incorporated by reference from Form 8-K Report of Gamogen, Inc. dated Jan 24, 1997.
</TABLE>
18
<PAGE>
SIGNATURES
Pursuant to the requirements of Section 13 or 15 (d) of the Securities Exchange
Act of 1934, the Registrant has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized.
GAMOGEN, INC.
/s/ Andrew I. Sealfon
- ---------------------
Andrew I. Sealfon, President, Treasurer,
Chairman of the Board, Director, and
Chief Executive Officer
Dated: May 20, 1997
Pursuant to the requirements of the Securities Exchange Act of 1934, this
report has been signed below by the following persons on behalf of the
Registrant and in the capacities and on the dates indicated.
<TABLE>
<S> <C>
/s/ Andrew I. Sealfon May 20, 1997
- ---------------------
Andrew I. Sealfon, President, Treasurer, Chairman of the Board,
Director, and Chief Executive Officer
/s/ Jesse A. Garringer May 20, 1997
- ----------------------
Jesse A. Garringer, Executive Vice-President, Secretary,
Director, and Chief Financial Officer
/s/ Dr. Paul Mark Baker May 20, 1997
- -----------------------
Dr. Paul Mark Baker, Director
</TABLE>
19
<PAGE>
WEINGAST, ZUCKER & RUTTENBERG, LLP
CERTIFIED PUBLIC ACCOUNTANTS
11 HOLLAND AVENUE
WHITE PLAINS, NEW YORK 10603
INDEPENDENT AUDITORS' REPORT
BOARD OF DIRECTORS
GAMOGEN, INC. AND SUBSIDIARY
We have audited the accompanying consolidated balance sheets of Gamogen, Inc.
and Subsidiary as of February 28, 1997 and 1996, and the related consolidated
statements of income, stockholders' equity and cash flows for each of the two
years in the period ended February 28, 1997. These financial statements are the
responsibility of the Company's management. Our responsibility is to express an
opinion on these financial statements based on our audit.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of
material misstatement. An audit includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements. An audit
also includes assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall financial
statement presentation. We believe that our audit provides a reasonable basis
for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the consolidated financial position of Gamogen, Inc. and
Subsidiary as of February 28, 1997, and the results of their operations and
their cash flows for each of the two years in the period ended February 28,
1997, in conformity with generally accepted accounting principles.
/s/ Weingast, Zucker & Ruttenberg, LLP
- --------------------------------------
White Plains, NY
May 16, 1997
20
<PAGE>
Gamogen, Inc. and Subsidiary
Consolidated Balance Sheets
----------------------------
<TABLE>
<CAPTION>
Feb 28, 1997 Feb 29, 1996
------------ ------------
Assets
- ------
Current Assets
- --------------
<S> <C> <C>
Cash $ 1,368 $ 431
Accounts Receivable 23,657 33,816
Inventory (Notes 1 & 2) 169,500 176,480
Prepaid Expenses 3,960 5,987
----------- -----------
Total Current Assets 198,485 216,714
----------- -----------
Property, Equipment and Other Assets (Notes 1 & 3)
- --------------------------------------------------
Property and Equipment, Net 25,954 34,176
Other Assets, Net 171,693 177,224
----------- -----------
Total Property, Equipment and Other Assets 197,647 211,400
----------- -----------
Total Assets $ 396,132 $ 428,114
============ =========== ===========
Liabilities and Stockholders' Equity
- ------------------------------------
Current Liabilities
- -------------------
Accounts Payable $ 0 5,849
Accrued Expenses 10,468 2,570
Other Liabilities - Due To Affiliate (Note 4) 66,314 108,170
----------- -----------
Total Current Liabilities 76,782 116,589
----------- -----------
Stockholders' Equity
Common Stock, $.01 Par Value Authorized 4,000,000
Shares, Issued and Outstanding 1,230,000 12,300 12,300
Warrants Outstanding 40 40
Additional Paid-In Capital 1,579,723 1,579,723
Accumulated (Deficit) (1,272,713) (1,280,538)
----------- -----------
Total Stockholders' Equity 319,350 311,525
----------- -----------
Total Liabilities and Stockholders' Equity $ 396,132 428,114
========================================== =========== ============
</TABLE>
See Notes To Financial Statements
21
<PAGE>
Gamogen, Inc. and Subsidiary
Consolidated Statements of Income (Loss)
For the Years Ended
----------------------------------------
<TABLE>
<CAPTION>
Feb 28, 1997 Feb 29, 1996 Feb 28, 1995
------------ ------------ ------------
<S> <C> <C> <C>
Sales (Note 4) $343,675 $ 394,467 $ 373,897
Costs and Expenses:
- -------------------
Cost of Goods Sold 148,382 166,614 148,641
Selling, General and Administrative 330,334 325,437 253,899
Depreciation and Amortization 13,753 14,216 15,257
------------ ------------ ------------
492,469 506,267 417,797
------------ ------------ ------------
Net Income (Loss) From Operations (148,794) (111,800) (43,900)
Other Income (Expense):
- -----------------------
Licensing Income (Note 5) 162,800 0 47,107
Loss on Termination of Lease 0 0 (35,609)
Interest & Other Income 1,096 522 1,674
------------ ------------ ------------
163,896 522 13,172
------------ ------------ ------------
Net Income Before Income Taxes 15,102 (111,278) (30,728)
Provision (Benefit) For Income Taxes (Note7) 7,277 0 0
------------ ------------ ------------
Net Income (Loss) $ 7,825 $ (111,278) $ (30,728)
================= ============ ============ =============
Net Income (Loss) Per Common
Share (Notes 1 & 6) $ 0.01 $ (0.09) $ (0.02)
============================ =============== =========== ============
</TABLE>
See Notes To Financial Statements
<PAGE>
Gamogen, Inc. and Subsidiary
Statements of Cash Flow
For the Years Ended
----------------------------
<TABLE>
<CAPTION>
Feb 28, 1997 Feb 29, 1996
------------ ------------
Cash Flow From Operating Activities:
- ------------------------------------
<S> <C> <C>
Net Income (Loss) 7,825 (111,278)
Adjustments To Reconcile Net Income (Loss)
To Cash Provided By (Used In) Operating Activities:
Depreciation and Amortization 13,753 14,216
(Increase) Decrease In Prepaid Expenses 2,027 24
(Increase) Decrease in Accounts Receivable 10,159 (5,520)
(Increase) Decrease in Inventory 6,980 (41,340)
Increase (Decrease) in Accounts Payable (5,849) 4,739
Increase (Decrease) in Accrued Expenses 7,898 (10,902)
Increase (Decrease) in Other Liabilities - Due To Affiliate (41,856) 96,481
------------ ------------
Cash Provided By (Used In) Operating Activities 937 (53,580)
Cash - Beginning of Year 431 54,011
------------ ------------
Cash - End of Year $ 1,368 $ 431
================== ============ ============
Supplementary Data - Income Taxes Paid $ 894 $ 1,260
- ------------------
</TABLE>
See Notes To Financial Statements
- ---------------------------------------------------------------------
Gamogen, Inc. And Subsidiary
Consolidated Statements of Stockholders' Equity
-----------------------------------------------
<TABLE>
<CAPTION>
Warrants
and
Common Stock Additional
Total .01 Par Value Paid-In Accumulated
Equity Shares $ Amt. Capital (Deficit)
------ ------------------ ---------- -----------
<S> <C> <C> <C> <C> <C>
Stockholders' Equity 2/94 $ 453,531 1,230,000 $ 12,300 $1,579,763 $(1,138,532)
Net Loss FYE 2/95 (30,728) (30,728)
-------- -----------
Stockholders' Equity 2/95 422,803 1,230,000 12,300 1,579,763 (1,169,260)
Net Loss FYE 2/96 (111,278) (111,278)
-------- -----------
Stockholders' Equity 2/96 311,525 1,230,000 12,300 1,579,763 (1,280,538)
Net Income FYE 2/97 7,825
7,825
---------
Stockholders' Equity 2/97 $ 319,350 1,230,000 $ 12,300 $1,579,763 $(1,272,713)
</TABLE>
See Notes To Financial Statements
23
<PAGE>
Gamogen, Inc. and Subsidiary
Notes to Consolidated Financial Statements
February 28, 1997 and 1996
------------------------------------------
Note 1 - Organization and Summary of Significant Accounting Policies
- ------ -----------------------------------------------------------
A. Gamogen, Inc. (the "Company) was incorporated on March 17, 1986 to acquire,
develop and market medical products and services.
These consolidated financial statements include the accounts of Gamogen, Inc.
and Gyneco, Inc. All intercompany balances and transactions have been
eliminated in consolidation.
B. The Company has acquired from Repro-Med Systems, Inc. all rights and
technology to certain impotence products being developed. Repro-Med Systems,
Inc owns 699,200 shares of the Company's Common Stock.
C. Property and Equipment is stated at cost. Property is being depreciated over
thirty-one and a half years and equipment is being depreciated over five to
twelve years utilizing both the straight-line and accelerated methods of
depreciation.
D. Costs incurred in obtaining patents have been capitalized and are being
amortized over seventeen years. Organization costs have been capitalized and
are being amortized over five years. Goodwill costs have been capitalized and
are being amortized over thirty-five years.
E. Inventory is valued at the lower of cost (first-in, first-out method), or
market.
F. The Company has approved an Incentive Stock Option Plan which authorizes the
granting of options to key employees to purchase 40,000 shares of the Company's
Common Stock. To date, no options have been granted under the plan.
G. Losses per share are based on the weighted average number of shares of
Common Stock Outstanding and Common Stock Equivalents. The number of shares
outstanding at February 28, 1997 and 1996 is 1,230,000.
Note 2 - Inventory
- ------ ---------
February 28, 1997 February 29, 1996
----------------- -----------------
Inventory consists of:
Raw Materials $ 69,112 $ 101,538
Work in Process 34,510 22,071
Finished Goods 65,878 52,871
--------- ----------
Total $ 169,500 $ 176,480
--------- ----------
24
<PAGE>
Gamogen, Inc., and Subsidiary
Notes to Financial Statements
February 28, 1997 and February 29, 1996
---------------------------------------
Note 3 - Property, Equipment And Other Assets
- ------ ------------------------------------
<TABLE>
<CAPTION>
Property and Equipment: February 28,1997 February 29,1996
- ----------------------- ---------------- ----------------
<S> <C> <C>
Furniture and Equipment $ 172,639 $ 172,639
Building Improvements 0 30,685
Less: Accumulated Depreciation (146,685) (169,148)
----------- -----------
Net Property and Equipment $ 25,954 $ 34,176
- -------------------------- ----------- -----------
Other Assets:
Patent Costs $ 106,792 $ 106,792
Goodwill 14,137 14,137
Less: Accumulated Amortization (102,803) (97,272)
----------- ----------
18,126 23,657
Impotence Technology 153,567 153,567
----------- ----------
Net Other Assets $ 171,693 $ 177,224
- ---------------- ----------- -----------
</TABLE>
The Company will amortize the Other Asset - Impotence Technology of $153,567
beginning in the fiscal year ended February 28, 1998 based upon the outcome of
the FDA review or approval of the Zonagen Inc. Oral Treatment for male
impotency. If the Oral Treatment is approved by the FDA, amortization will be
taken over a shorter period of time than if the Oral Treatment is not approved
(See Note 5).
Note 4 - Related Party Transactions
- ------ --------------------------
Included in sales for the years ended February 1997, 1996, and 1995 were
$62,776, $62,973, and $47,401, respectively, received from an affiliate for use
of tooling equipment.
The Company has derived a significant portion of its funds for continuing
operation as a result of loan advances from an affiliate of the Company. As of
February 28, 1997 outstanding net loan advances from the affiliate are $66,314
and are included in Other Current Liabilities - Due To Affiliate.
Note 5 - Licensing Income
- ------ ----------------
The Company is receiving licensing income from Zonagen, Inc. from its sale of
rights to Zonagen, Inc. for the Company's Oral Treatment for male impotency.
Note 6 - Earnings Per Share
- ------ ------------------
Earnings per share are computed by dividing net earnings by the weighted
average number of shares of Common Stock and Common Stock Equivalents
outstanding during the period.
<TABLE>
Earnings Per Common Share February 28, 1997 February 29, 1996 February 28, 1995
- ------------------------- ----------------- ----------------- -----------------
<S> <C> <C> <C>
Net Earnings Per Share $0.01 $ (0.09) $ (0.02)
Number of Shares 1,230,000 1,230,000 1,230,000
</TABLE>
Note 7 - Income Tax
- -------------------
At February 28, 1997 the Company had cumulative federal net operating losses of
approximately $1,273,000. These losses can be carried forward for fifteen years
and begin to expire on February 28, 2002.
25
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<S> <C>
<FISCAL-YEAR-END> Feb-28-1997
<PERIOD-END> Feb-28-1997
<PERIOD-TYPE> 12-MOS
<CASH> 1,368
<SECURITIES> 0
<RECEIVABLES> 23,657
<ALLOWANCES> 0
<INVENTORY> 169,500
<CURRENT-ASSETS> 198,485
<PP&E> 172,639
<DEPRECIATION> 146,685
<TOTAL-ASSETS> 396,132
<CURRENT-LIABILITIES> 76,782
<BONDS> 0
0
0
<COMMON> 12,300
<OTHER-SE> 307,050
<TOTAL-LIABILITY-AND-EQUITY> 396,132
<SALES> 343,675
<TOTAL-REVENUES> 343,675
<CGS> 148,382
<TOTAL-COSTS> 492,469
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> 15,102
<INCOME-TAX> 7,277
<INCOME-CONTINUING> 7,825
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 7,825
<EPS-PRIMARY> 0.01
<EPS-DILUTED> 0.01
</TABLE>
