SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-QSB
(MARK ONE)
X QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES
----- EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED
JUNE 30, 2000 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: 0-30619
TRINITY MEDICAL GROUP USA, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
<TABLE>
<CAPTION>
<S> <C>
FLORIDA 68-0438943
--------------------------------------------------- ----------------------------------------
(STATE OR OTHER JURISDICTION OF INCORPORATION) (I.R.S. EMPLOYER IDENTIFICATION NO.)
3753 HOWARD HUGHES PARKWAY, 2ND FLOOR, LAS VEGAS, NV 89109
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES WITH ZIP CODE)
(415) 256-1995
(REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE)
N/A
(FORMER NAME, FORMER ADDRESS AND FORMER FISCAL YEAR, IF CHANGED SINCE LAST REPORT)
</TABLE>
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. YES X NO
----- -----
APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE
PRECEDING FIVE YEARS:
Indicate by check mark whether the registrant has filed all documents and
reports required to be filed by Section 12, 13 or 15(d) of the Securities
Exchange Act of 1934 subsequent to the distribution of securities under a plan
confirmed by a court. YES NO
----- -----
APPLICABLE ONLY TO CORPORATE ISSUERS:
Indicate the number of shares outstanding of each of the issuer's classes of
common stock, as of the latest date.
Class Outstanding at August 14, 2000
Common Stock - $0.001 par value 10,226,000 shares
<PAGE>
INDEX
<TABLE>
<CAPTION>
PAGE
----
<S> <C>
COVER PAGE.............................................................................................1
INDEX..................................................................................................2
PART I - FINANCIAL INFORMATION
Item 1 - Interim Financial Statements
Balance Sheets......................................................................3
Statements of Operations............................................................4
Statements of Cash Flows............................................................5
Notes to Financial Statements.......................................................6
Item 2 - Management's Discussion and Analysis of
Financial Condition and Results of Operation........................................8
PART II - OTHER INFORMATION
Item 2 - Changes in Securities and Use of Proceeds...........................................11
Item 6 - Exhibits and Reports on Form 8-K....................................................12
</TABLE>
2
<PAGE>
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIALS
TRINITY MEDICAL GROUP USA, INC.
(a company in the development stage)
BALANCE SHEETS
<TABLE>
<CAPTION>
ASSETS
June 30, December 31,
2000 1999
------------------ ------------------
(unaudited)
Current Assets:
<S> <C> <C>
Cash $ 33,303 $ 171,485
Subscription receivable from founding shareholders - 9,600
Income tax refund receivable 18,951 18,951
------------------ ------------------
Total current assets $ 52,254 $ 200,036
================== ==================
Computer Equipment 2,100 _____________
------------------ ------------------
Total current assets $ 54,254 $ $200,036
================== ==================
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current Liabilities
Accounts payable $ 2,000 $ 10,343
Accrued commissions 76,700 73,250
Accrued interest payable 48,648 11,345
------------------ ------------------
Total current liabilities 127,348 94,938
Convertible Notes Payable 772,500 732,500
Stockholders' deficit
Convertible Preferred Stock, no par value, 1,000,000 shares
authorized, 9 shares issues and outstanding 34,500
Common Stock, $0.001 par value, 50,000,000 shares authorized,
10,226,000 shares issued and outstanding 10,226 10,226
Additional paid-in capital 228,574 228,574
Deficit accumulated during the development stage (1,118,794) (866,202)
------------------ ------------------
Total stockholders' deficit (845,494) (627,402)
------------------ ------------------
Total liabilities and stockholders' deficit $ 54,354 $ 200,036
================== ==================
</TABLE>
The accompanying notes are an integral part of these statements.
3
<PAGE>
TRINITY MEDICAL GROUP USA, INC.
(a company in the development stage)
STATEMENTS OF OPERATIONS
Period From Inception (September 28, 1998) to June 30, 2000
And three months ended June 30, 2000
<TABLE>
<CAPTION>
Cumulative Three Months Six Months
from inception Ended Ended
to June 30, June 30,
June 30, 2000 2000 2000
------------- ------------ ----------
(unaudited) (unaudited) (unaudited)
<S> <C> <C>
Operating expenses
Research and development $ (294,000) $ - $ -
General and administrative
Acquisition costs $ (404,200) $ - $ -
Administrative costs $ (288,400) $ (88,485) $ (216,409)
Marketing costs (78,250) - -
------------- ------------ --------------
Total operating expenses (1,064,850) (88,485) (216,409)
Other income (expense):
Interest income $ 3,148 $ 78 $ 1,120
Interest expense $ (48,647) $ (18,645) $ (37,303)
Other income $ (8,445) $ - $ -
------------- ------------ --------------
(53,944) (18,567) (36,183)
------------- ------------ --------------
Net Loss (1,118,794) (107,052) (252,592)
============= ============ ==============
Basic and diluted loss per common
share $ (0.01) $ (0.02)
============ ==============
Basic and diluted weighted average
common shares outstanding $ 10,226,000 $ 10,226,000
============ ==============
</TABLE>
The accompanying notes are an integral part of these statements.
4
<PAGE>
TRINITY MEDICAL GROUP USA, INC.
(a company in the development stage)
STATEMENTS OF CASH FLOWS
Period From Inception (September 28, 1998) to June 30, 2000
And Three Months ended June 30, 2000
<TABLE>
<CAPTION>
Cumulative
from inception
to Six Months Ended
June 30, 2000 June 30, 2000
----------- -----------
(unaudited) (unaudited)
Cash flows from operating activities:
<S> <C> <C>
Net loss $ (1,118,793) $ (252,592)
Adjustments to reconcile net loss to net cash used in
operating activities
Stock issued for services 229,200 -
Loss on sale of investment 8,445 -
Changes in assets and liabilities:
Income tax refund receivable (18,952) -
Accounts payable 2,000 (8,343)
Accrued liabilities 125,348 40,753
------------------ ------------------
Net cash used in operating activities 772,752 (220,182)
------------------ ------------------
Cash flows from investing activities:
Purchase of fixed assets (2,100) (2,100)
Purchase of investments (69,330) -
Proceeds from sale of investments 60,885 -
------------------ ------------------
Net cash used in investing activities (10,545) (2,100)
------------------ ------------------
Cash flows provided by financing activities:
Proceeds from issuance of convertible notes payable 772,500 40,000
Proceeds from sale of preferred stock 34,500 34,500
Collection of subscription receivable 9,600 9,600
------------------ ------------------
Net cash provided by financing activities 816,600 84,100
------------------ ------------------
Net increase (decrease) in cash 33,303 (138,182)
Cash - beginning of period - 171,485
------------------ ------------------
Cash - end of period $ 33,303 $ 33,303
================== ==================
Non-cash investing and financing activities:
Issuance of common stock to founding shareholders in exchange
for subscription receivable $ 9,600 $ -
------------------ ------------------
</TABLE>
The accompanying notes are an integral part of these statements.
5
<PAGE>
TRINITY MEDICAL GROUP USA, INC.
(a company in the development stage)
CONDENSED NOTES TO FINANCIAL STATEMENTS
December 31, 1999 to June 30, 2000 (unaudited)
NOTE A - BASIS OF PRESENTATION
The accompanying unaudited financial statements contain all adjustments
(consisting only of normal recurring adjustments) which in the opinion of
management are necessary to present fairly the financial position of the Company
at June 30, 2000, and the results of its operations and its cash flows for the
three month period ended June 30, 2000. The financial statements do not include
comparative first quarter information because the Company had no activity during
the first quarter ended June 30, 2000. Certain information and footnote
disclosures normally included in financial statements have been condensed or
omitted pursuant to rules and regulations of the Securities and Exchange
Commission, although the Company believes that the disclosures in the financial
statements are adequate to make the information presented not misleading.
The financial statements included herein should be read in conjunction with the
financial statements included in the Company's Form 10-SB for the year ended
December 31, 1999, filed with the Securities and Exchange Commission on May 12,
2000.
NOTE B - CAPITALIZATION POLICY
Equipment is recorded at cost. Depreciation is provided using the straight-line
method over the useful lives of the related assets, which ranges from three to
five years. The cost and related accumulated depreciation of equipment sold or
otherwise disposed of are removed from the accounts and the resulting gain or
losses are included in the statement of operations.
NOTE C - GOING CONCERN
The accompanying financial statements have been prepared on a going concern
basis, which contemplates the realization of assets and the satisfaction of
liabilities in the normal course of business. As shown in the financial
statements, the Company is in the development stage and, at June 30, 2000 has
accumulated losses from operations amounting to $1,118,794. For the six month
period ended June 30, 2000, and for the period from inception to June 30, 2000
the Company used $220,182 and $772,752, respectively, of cash in its operations.
Additional testing of the drug therapy, Remune, will require significant
additional financing. These factors, among others, raise substantial doubt about
the Company's ability to continue as a going concern. The financial statements
do not include any adjustments relating to the recoverability and classification
of recorded asset amounts or the amounts and classification of liabilities that
might be necessary should the Company be unable to continue as a going concern
for a reasonable period of time.
Upon becoming a reporting company under United States securities laws, the
Company intends to acquire, in the near term, the rights to Remune and assume
the related obligations specified under the Stock Purchase
6
<PAGE>
TRINITY MEDICAL GROUP USA, INC.
(a company in the development stage)
CONDENSED NOTES TO FINANCIAL STATEMENTS
December 31, 1999 to June 30, 2000 (unaudited)
Agreement for TMG. The Company intends to market Remune in the countries where
it has the rights through partner or affiliated firms, which will carry out the
local regulatory requirements, distribution, and product support. The Company
intends to finance the aforementioned activities through a secondary offering
for between $15,000,000 and $20,000,000. The Company's initial efforts have
focused on the research and development of Remune (through TMG) and securing
sales and marketing rights in Thailand.
There can be no assurance that management will be successful in raising the
necessary funds to complete the clinical trials and obtain the necessary
government approvals for the manufacturing and sale of Remune. The Company's
ability to continue as a going concern will depend upon these factors and the
success of future operations.
NOTE D- CONVERTIBLE NOTES PAYABLE
During the six month period ended June 30, 2000, the Company sold 8 units of its
convertible notes payable at a price of $5,000 per unit to accredited investors
in a private placement offering. Each unit consists of a $5,000, 10% note due
August 30, 2001. Each unit is convertible into 5,000 shares of the Company's
common stock at the election of the Company. Interest accrued on each unit is
convertible to common stock at a rate of $1 per share at the date of conversion.
As of June 30, 2000, no units had been converted to common stock.
NOTE E- CONVERTIBLE PREFERRED STOCK
On June 21, 2000, the Company began to raise additional capital under a new
private placement offering. The private placement offers a maximum of 175 units
at $4,000 per unit. Each unit consists of one hundred shares of the Company's
Series A Preferred Stock (the "Preferred Shares") and a non-callable common
stock purchase warrant (the "Warrant"), designated "A Warrants". Each Preferred
Share is convertible, at the Company's option, into 10 shares of the Company's
common stock par value $0.01 (the "Common Stock"). Each of the A Warrants
entitles the registered holder to purchase up to one thousand shares of the
Common Stock at a price of $4.00 per share for a period of 24 months from the
date of the Private Placement Prospectus. The Preferred Shares and the Warrant
included in the units will not be separately transferable until 90 days after
the date of the Prospectus or such earlier date as the Company may determine.
The Preferred Shares can be converted at the Company's discretion into Common
Stock no later than October 1, 2000 and with approval by the Securities and
Exchange Commission (the "SEC") for the registration of the shares of Common
Stock issuable upon conversion of the Preferred Shares and upon exercise of the
A Warrants. The Company has raised $34,500 under this private placement offering
during the three months ended June 30, 2000. Subsequent to June 30, 2000, the
Company raised an additional $628,000 through this private placement offering.
7
<PAGE>
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND
FINANCIAL CONDITION
Plan of Operation
-----------------
Trinity Medical Group USA, Inc. (the "Company") was incorporated in the State of
Delaware on September 28, 1998 and reincorporated in Nevada in November of 1999
with its principal place of business in California. In December 1999, as the
result of a reorganization, the Company became a Florida corporation. The
Company is an affiliate of Trinity Medical Group, Ltd., a Thailand company
(http: //www.trinitygroups/trinity medical/dsmb.htm) ("TMG"). The Company is a
late development stage company with potential rights to market a patented
vaccine, ("Remune"), designed to induce specific T cell responses in people
infected with the Human Immunodeficiency Virus (HIV). Remune (an immune-based
therapy consisting of whole inactivated HIV-1 virus depleted of its gp120 coat
protein) is based on Dr. Jonas Salk's vaccine technology.
TMG was formed in 1995 after the principals of the TMG and The Immune Response
Corporation (NASDAQ: IMNR) entered into a License and Collaboration Agreement
(the "License and Collaboration Agreement") dated September 15, 1995 with The
Immune Response Corporation to develop and market Remune in ten Southeast Asian
countries including Malaysia, The Philippines, Singapore, Sri Lanka, Myanmar,
Laos, Cambodia, Vietnam and Indonesia, with Thailand as the lead nation (the
"Territory"). On the same day, TMG entered into a Stock Purchase Agreement (the
"Stock Purchase Agreement") with the Immune Response Corporation. Per the Stock
Purchase Agreement, TMG purchased 333,334 shares of The Immune Response
Corporations stock at $15 per share on April 30, 1996. TMG is further obligated
to purchase an additional 333,333 shares of The Immune Response Corporation's
stock at $15 per share upon receiving the required marketing approval from the
governing health authority of Thailand for the drug therapy Remune. TMG is
further obligated to purchase another 333,333 shares of The Immune Response
Corporation's stock at $15 per share upon receiving the required factory
establishment license or approval from the governing health authority of
Thailand to manufacture the drug therapy Remune. TMG recognized the vaccine's
potential in 1995 and paid The Immune Response Corporation $5 million in cash to
secure the rights to develop and market Remune in Southeast Asia.
The Company entered into a Collaboration and Supply Agreement (the "Agreement")
with TMG, dated December 1,1999. Under the terms of the Agreement, the Company
will reimburse TMG for specified research personnel, travel, laboratory,
facility and publication costs associated with clinical trials of Remune until
full regulatory approval in Thailand is granted.
The Agreement also provides that the Company make its best efforts to capitalize
itself with at least $4,000,000 through sale or subscription of common class
shares not to exceed 1 million shares. The Company agrees to prepare and
complete all necessary documentation required for registration of the Company
with the U.S. Securities and Exchange Commission as a reporting company.
In 1999, TMG completed a Phase II double blind placebo controlled clinical trial
in Thailand, the results of which were submitted to the Thailand Food and Drug
Administration for review in March, 2000. In the clinical trial above, Remune
was found to increase mean CD4+ cell counts, with increases in both cellular and
humoral immune responses and stable viral load. A follow up study through
eighty-eight (88) weeks showed a significant decrease of viral load in 30% of
the subjects.
On December 24, 1999, TMG applied for expanded testing with the Ministry of
Public Health in Thailand. The extended project, which has since been approved,
will be coordinated by Mahidol University in Bangkok, Thailand and will confirm
the effectiveness of Remune and study the long term effects in about 10,000 HIV
infected individuals. The financial implications of this study are not known at
this time but the company anticipates revenue from this study during 2000. This
extended study of Remune is not connected to the request for full commercial
8
<PAGE>
approval by the Thai Food and Drug Administration. This extended study of Remune
is not connected to the request for full commercial approval by the Thai Food
and Drug Administration.
The results of the Phase II controlled trial were presented the XIII
International AIDS Conference in Durban, South Africa by Dr. Vina
Churdboonchart. The results of the Phase II clinical trials in Thailand and
other clinical trials using Remune as a treatment for slowing HIV-related
disease progression are encouraging. The global burden of disease and death
related to HIV is increasing at a rate unmatched by any other pathogen. At
present, the most effective treatment for slowing HIV-related disease
progression, antiretoviral medication requiring a daily multi-pill regime, is
complicated to administer, requires close medical monitoring, is extremely
costly, and can cause significant adverse effects in some cases. The study
conditions of the clinical trials in Thailand allowed Remune to be assessed as a
"mono-therapy", that is, without any other anti-viral drugs. Remune requires a
minimum of a once a quarter (or more if needed) injection. As a result, Remune
is both more economical and practical for populations such as Thailand. As
released by MOPH, Thailand, the official number of HIV infected people in
Thailand is 1.0 million people. The estimate for South Asia is approximately 9
million HIV-1 infected people. Remune is potentially a very cost effective
therapy for the treatment of HIV among Thailand's poorest people.
Cash requirements over the next 12 months.
------------------------------------------
Pursuant to a private offering (the "December Private Placement"), the Company
raised $732,500 at the end of 1999 and an additional $40,000 during June 2000.
In the December Private Placement, the Company offered for purchase to
accredited investors 154.5 units at a price of $5,000 per unit. Each unit
consists of a $5,000, 10% per annum note of the Company due August 31, 2001
convertible into 5,000 shares of the Company's Common Stock, par value $.001 per
share (collectively, the "Units").
Over the next 12 months, the Company will require additional capital through the
sale of shares of capital stock or issuance of debt in order to meet its
business needs. The Company anticipates revenue from sale of Remune in Thailand
later this year. The Company is in the process of negotiating Remune licensing
agreements and, if completed, anticipates substantial revenue from licensing
Remune in other countries during the year but cannot predict the amount of
proceeds or the timing of the completion of such transactions.
The current cash on hand will be sufficient to fund operations through the third
quarter of 2000. During the second quarter we received subscriptions for $34,500
in a private offering (the "June Private Placement") through the issuance of a
new class of Preferred Shares and Warrant and expect proceeds of $628,000 during
the third quarter of 2000. In the third quarter we plan to file a registration
statement to register the shares of capital stock issuable under the December
Private Placement and the June Private Placement and two million shares of
common stock that would be sold to the public in a secondary offering. The
secondary offering is projected to produce between $15 million and $30 million
is cash. The Company plans to use $10 million of the proceeds to satisfy the
Stock Purchase Agreement with the Immune Response Corporation, import Remune to
Thailand, and to cover initial expenses for the establishment of Thai
manufacturing facilities as well as The Trinity Immune and Health Center which
will primarily cater to the HIV+ population.
Product Research and Development Plans
--------------------------------------
The Company intends to secure regulatory approval for sale of Remune in Thailand
during the calendar year 2000. Our researchers have concluded a Phase II
clinical study in Thailand of about 300 individuals infected with HIV and
continue to analyze the study group. The results of this study were presented in
five major
9
<PAGE>
scientific conferences in 2000: at the UN/WHO AIDS conference in Geneva,
Switzerland, the UCLA AIDS Conference held in Palm Springs, California, the 5th
Asia-Pacific Congress of Medical Virology in Bali, Indonesia, the First Intl.
Conference on Vaccine Development and Immunotherapy in HIV, Florida, USA and the
XIII International AIDS Conference in Durban, South Africa. A manuscript
detailing the study has been secured and the Company anticipates publication
with positive response. Formal advise about publication is expected in September
of 2000. The Company believes it now has the necessary technical support for
full regulatory approval and is currently working on compiling documentation
required for registration of Remune in Thailand. Upon sufficient capitalization,
the Company intends to purchase plant, equipment and land leases in 2000 for a
handling and storage facility in Thailand. The facility will be located close to
the Bangkok International Airport and will receive Remune shipment in bulk. The
facility will be built to U.S. FDA Good Manufacturing Practice standards and
provide for climate controlled and secure warehousing. The estimated cost for
the facility is $5 million and will require six months to one year to construct.
The capital for this project would be provided by product revenue and the sale
of shares of capital stock, issuance of debt or financing by a banking
institution. The Company intends to increase its employment base in the third
quarter of 2000. The Company will add a Chief Financial Officer, engineering
consultants and additional directors during the third quarter. From our present
level of two employees we estimate having about 10 employees by year-end.
PART II - OTHER INFORMATION
ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS
Pursuant to an Agreement for the Exchange of Common Stock, dated December 31,
1999, between the shareholders of the Company and August Project III Corp., a
Florida corporation ("August Project"), August Project issued to the Company's
shareholders 5,226,000 shares of Common Stock in exchange for 100% of the
outstanding shares of the Company. In addition, certain shareholders of August
Project sold 4,867,000 shares to the shareholders of the Company in exchange for
$175,000. Following the merger, the shareholders of the predecessor Company
owned a total of 10,093,000 out of a total of 10,226,000 outstanding shares of
August Project. August Project was the surviving corporation after the merger.
Prior to the merger, August Project had been approved for listing on the
National Quotation Service Pink Sheets with the following trading symbol: AUUK.
On January 5, 2000, August Project changed its name to Trinity Medical Group
USA, Inc.
In connection with the December Private Placement the Company issued 154.5
notes. The notes were sold to "accredited investors", as that term is defined in
Regulation D promulgated under the Securities Act of 1933, as amended (the
"Securities Act"). The notes were sold in Units. Each Unit cost $5,000 and
consisted of a $5,000, 10% per annum note of the Company due August 31, 2001
convertible into 5,000 shares of the Company's common stock, $0.001 par value,
per share (the "Notes"). The aggregate offering price was $772,500 and the
Company received net proceeds in the amount of $772,500. The Company believes
that the exemption afforded by Section 4(2) of the Securities Act and Regulation
D promulgated thereunder, is applicable to the above issuances as a transaction
by an issuer not involving a public offering.
On May 12, 2000 the Company submitted a Form 10SB to the SEC in order to become
a publicly reporting concern. On May 19, the SEC notified the Company that the
filing was acknowledged and would not need to be reviewed; thus allowing the
Company to proceed with its plans. The Company shares now trade under the symbol
TMGU in the National Quotation Service Pink Sheets. The Company is presently
seeking listing on NASD Over the Counter Bulletin Board exchange and hopes to
have listing on the Small Cap NASDAQ
10
<PAGE>
market in the third quarter.
The Company has paid no dividends on its common stock and cannot assure that it
will achieve sufficient earnings to pay cash dividends on its common stock in
the near future. Further, the Company intends to retain earnings to fund its
operations. Therefore, the Company does not anticipate paying any cash dividends
on its common stock in the foreseeable future.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
A) EXHIBITS:
27 Financial Data Schedule
B) REPORTS ON FORM 8-K
The Company did not file any reports on Form 8-K during the six months
ended June 30, 2000.
11
<PAGE>
SIGNATURES
Pursuant to the requirements 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.
TRINITY MEDICAL GROUP USA, INC.
/s/ James Namnath
----------------------------
By: James Namnath
Chief Executive Officer
12
