As
filed with the Securities and Exchange Commission on February 27, 2008
Registration No. 333
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
AMDL, INC.
(Exact name of registrant as specified in its charter)
|
|
|
Delaware
(State or other jurisdiction
of incorporation or organization)
|
|
33-0413161
(I.R.S. Employer
Identification No.)
|
2492 Walnut Avenue, Suite 100
Tustin, California 92780-7039
(714) 505-4460
(Address, including zip code, and telephone number, including
area code, of registrants principal executive offices)
Gary L. Dreher, President
AMDL, Inc.
2492 Walnut Avenue, Suite 100
Tustin, California 92780-7039
(714) 505-4460
(Name, address, including zip code, and telephone
number, including area code, of agent for service)
Copy to:
Randolf W. Katz, Esquire
Bryan Cave LLP
1900 Main Street, Suite 700
Irvine, California 92614
(949) 223-7100
Richard H. Bruck, Esquire
19100 Von Karman Avenue, Suite 950
Irvine, California 92612
(949) 975-8181
Approximate date of commencement of proposed sale to the public:
From time to time after the effective date of this Registration Statement
If the only securities being registered on this Form are being offered pursuant to dividend or
interest reinvestment plans, please check the following box:
o
If any of the securities being registered on this Form are to be offered on a delayed or continuous
basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in
connection with dividend or interest reinvestment plans, check the following box:
þ
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b)
under the Securities Act, please check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same offering:
o
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act,
check the following box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering:
o
If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective
amendment thereto that shall become effective upon filing with the Commission pursuant to rule
462(e) under the Securities Act, check the following:
o
If this Form is a post-effective amendment to a registration statement filed pursuant to General
Instruction I.D. filed to register additional securities or additional classes of securities
pursuant to Rule 413(b) under the Securities Act, check the following:
o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in
Rule 12b-2 of the Exchange Act. (Check one):
|
|
|
|
|
|
|
Large Accelerated
filer
o
|
|
Accelerated filer
o
|
|
Non-accelerated filer
o
|
|
Smaller reporting company
þ
|
|
|
(Do not check if a smaller reporting company)
|
CALCULATION OF REGISTRATION FEE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proposed
|
|
|
Proposed
|
|
|
|
|
|
|
|
|
|
|
|
maximum
|
|
|
maximum
|
|
|
|
|
|
Title of each class of
|
|
|
Amount
|
|
|
offering
price
|
|
|
aggregate
|
|
|
Amount of
|
|
|
securities to be registered
|
|
|
registered
(1)
|
|
|
per share
(1)(2)
|
|
|
offering price
(2)
|
|
|
registration fee
|
|
|
Common Stock, $.001
par value per share
|
|
|
|
4,345,257
|
|
|
|
$
|
3.18
|
|
|
|
$
|
13,817,918
|
|
|
|
$
|
543.04
|
|
|
|
|
|
|
(1)
|
|
In addition, pursuant to Rule 416 under the Securities Act of 1933, this Registration
Statement includes an indeterminate number of additional shares as may be issuable as a result
of stock splits or stock dividends which occur during this continuous offering.
|
|
(2)
|
|
Estimated solely for the purpose of calculating the amount of the registration fee pursuant
to Rule 457 under the Securities Act of 1933 based upon the reported closing sales price of
the registrants common stock on February 20, 2008 on the American Stock Exchange.
|
The registrant hereby amends this registration statement on such date or dates as may be necessary
to delay its effective date until the registrant shall file a further amendment which specifically
states that this registration statement shall thereafter become effective in accordance with
Section 8(a) of the Securities Act of 1933 or until the registration statement shall become
effective on such date as the Commission, acting pursuant to Section 8(a), may determine.
The information in this prospectus is not complete and may be changed.
We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective.
This prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any jurisdiction
where the offer or sale is not permitted.
SUBJECT
TO COMPLETION, DATED FEBRUARY 27, 2008
PROSPECTUS
AMDL, INC.
4,345,257 SHARES
OF COMMON STOCK
This prospectus relates to shares of common stock of AMDL, Inc. that may be offered for sale
for the account of the selling stockholders identified in this prospectus. The selling
stockholders may offer and sell from time to time up to 4,345,257 shares of our common stock, of
which 1,366,319 shares will be issued to the selling stockholders only if and when they exercise
warrants held by them.
The selling stockholders may sell all or any portion of their shares of common stock in one or
more transactions on the American Stock Exchange, in private, negotiated transactions or a
combination of such methods. Each selling stockholder will determine the prices at which it sells
its shares. Although we will incur expenses in connection with the registration of the common
stock, we will not receive any of the proceeds from the sale of the shares of common stock by the
selling stockholders. However, we will receive gross proceeds of up to approximately $6,476,000
from the exercise of outstanding warrants, if and when they are exercised.
On February 20, 2008, there were 15,731,329 shares of common stock outstanding. Our common
stock is listed on the American Stock Exchange and traded under the symbol ADL. On February 20,
2008, the closing price of the common stock on the American Stock Exchange was $3.18 per share.
We may amend or supplement this prospectus from time to time by filing amendments or
supplements as required. You should read this entire prospectus and any amendments or supplements
carefully before you make your investment decision.
The shares of common stock offered or sold under this prospectus involve a high degree of
risk. See Risk Factors beginning at page 18 of this prospectus to read about certain factors you
should consider before deciding whether to invest in our common stock.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or passed upon the accuracy or adequacy of this
prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is , 2008
TABLE OF CONTENTS
We have not authorized any person to give you any supplemental information or to make any
representations for us. You should not rely upon any information about us that is not contained in
this prospectus or in one of our public reports filed with the Securities and Exchange Commission
(SEC) and incorporated into this prospectus. Information contained in this prospectus or in our
public reports may become stale. You should not assume that the information contained in this
prospectus, any prospectus supplement or the documents incorporated by reference are accurate as of
any date other than their respective dates, regardless of the time of delivery of this prospectus
or of any sale of the shares. Our business, financial condition, results of operations and
prospects may have changed since those dates. The selling stockholders are offering to sell, and
seeking offers to buy, shares of our common stock only in jurisdictions where offers and sales are
permitted.
In this prospectus, AMDL, company, we, us, and our refer to AMDL, Inc., a Delaware
corporation, and its subsidiaries. In this prospectus, unless otherwise specified or unless the
context otherwise requires, all references to $ or
dollars are to U.S. dollars.
ABOUT FORWARD-LOOKING STATEMENTS
This prospectus contains and incorporates by reference forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act
of 1934 which reflect our current view (as of the date such forward-looking statement is made) with
respect to future events, prospects, projections or financial performance. These forward-looking
statements are subject to certain uncertainties and other factors that could cause actual results
to differ materially from those made, implied or projected in such statements. The words
believe, expect, anticipate, project, and similar expressions identify forward-looking
statements which speak only as of the date of the statement made. Except as required by law, we
undertake no obligation to publicly update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
2
BUSINESS
Overview of Our Business
We are an international bio-pharma company that investigates and develops pharmaceutical
products and diagnostic tests for both the detection and treatment of cancer. We also sell OEM
products and test kits which are manufactured by others. Our products may be used by hospital,
clinical, research and forensic laboratories and doctors offices to obtain precise and rapid
identification of certain types of cancer and other diseases. Our DR-70
®
test kit may
be used to assist in the detection of at least 14 different types of cancer, including: lung (small
and non-small cell); stomach; breast; rectal; colon; and liver. As DR-70
®
is a
non-invasive blood test, there are no side effects to the administration of our test. As with
other cancer diagnostic products, false negative and false positive results could pose a small risk
to patient health if their physician is not vigilant in following up on the DR-70
®
results with other modalities that are standard of care for these patients. DR-70
®
is
not yet available for sale in the United States (U.S.). Our DR-70
®
test kit cannot be
sold in the
U.S.
until we receive premarket approval for the DR-70
®
from the
U.S.
Food and Drug Administration (USFDA)
.
As more fully discussed below, we
have submitted a 510(k) application to the USFDA to obtain premarket approval for the
DR-70
®
as a Class II regulated device and such application is currently under review by
the USFDA.
Through our wholly-owned subsidiary, Jade Pharmaceutical Inc. (JPI), we manufacture and
distribute generic, homeopathic, over-the-counter pharmaceutical products and supplements. JPI
manufactures and distributes its products through two wholly-owned Chinese subsidiaries, Yangbian
Yiqiao Bio-Chemical Pharmacy Company Limited (YYB) and Jiangxi Jiezhong Bio-Chemical Pharmacy
Company Limited (JJB). JPI acquired the businesses currently conducted by YYB and JJB in 2005
along with certain assets and liabilities of a predecessor to JJB (JiangXi Shangrao KangDa
Biochemical Pharmacy Co. Ltd). YYBs facilities are located in Tuman City, Jilin Province, China
and JJB is located in Shangrao, Jiangxi Province, China. JPI also researches and develops other
pharmaceutical products which require the approval of the Peoples Republic of China State Federal
Drug Agency (SFDA).
Both JJB and YYB are wholly-foreign owned enterprises (WFOEs). WFOEs are limited liability
companies established under Chinese Company Law that are exclusively owned by foreign investors.
WFOEs are used to, among other things: enable local China based entities to carry on business in
China, rather than operate in a representative capacity; acquire land use certificates to own and
operate facilities in China; employ persons in China; hold intellectual property rights; protect
intellectual property and proprietary technology; and issue invoices to their customers in Renminbi
and record revenues in Renminbi, but convert the profits into U.S. dollars for distribution to
their parent company outside China. There are also potential disadvantages of operating as a WFOE,
including, but not limited to, unlimited liability claims arising from the operations in China and
potentially less favorable treatment from governmental agencies than would be afforded to those
entities operating with a Chinese partner.
We are in the process of establishing another series of entities, including another WFOE that
will acquire, manage and operate a chain of clinics to be known as JPGreen Health and Beauty
Clinics (JPGreen Clinics). The JPGreen Clinics will offer, in addition to a number of Esmond
brand and Jade brand generic pharmaceuticals, anti-aging injectibles and skin care products
containing human placental solution named Goodnak. Initially, the JPGreen Clinics will be
established in Shanghai, China.
Our executive offices are located at 2492 Walnut Avenue, Suite 100, Tustin, California 92780,
telephone number (714) 505-4460. In September 2001, we registered our common stock under the
Securities Exchange Act of 1934 and listed on the American Stock Exchange under the symbol ADL.
You may review any of our public reports or information on file with the SEC at the SECs Public
Reference Room at 100 F Street N.E., Room 1580, Washington, D.C., 20549. You may obtain
information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330 or
review our reports at
http://www.sec.gov
or
http://www.amdlcorporate.com.
Information on,
or
3
accessible through, our website is not incorporated into this prospectus unless this
prospectus specifically indicates otherwise.
Acquisition of Jade Pharmaceutical Inc.
On September 28, 2006, pursuant to the Stock Purchase and Sale Agreement dated May 12, 2006,
as amended, we acquired 100% of the outstanding shares of JPI (and hence, YYB and JJB, JPIs
subsidiaries) from Jade Capital Group Limited, a Hong Kong based British Virgin Islands company
(JCG). The aggregate purchase price of JPI was $9,116,896, consisting of 2,643,000 shares of our
common stock valued at $7,929,000 (based on the price of our common stock at the time of
acquisition), options to purchase 500,000 shares of our common stock valued at $595,000 (based on
the Black-Scholes option pricing model) and $592,896 in acquisition related transaction costs.
The terms of the Stock Purchase and Sale Agreement provided that 100,000 shares of our common
stock (the Escrow Shares) would be deposited into an escrow account held by a third-party escrow
agent until JCG or its shareholders demonstrated that the SFDA or other appropriate agency had
issued a permit or the equivalent regulatory approval, in form and substance satisfactory to us,
for JPI to sell and distribute DR-70
®
in China without qualification. Under the Escrow
Agreement, as amended, if JCG has not notified the escrow agent that the SFDA has issued the
approval to market DR-70
®
before March 31, 2008, or if we dispute that the purported
approval is satisfactory, the Escrow Shares shall be delivered by the escrow agent to us for
cancellation. In the event the Escrow Shares are released to JCG or its shareholders, we will
record the fair value of the 100,000 shares of common stock issued as goodwill.
In accordance with Statement of Financial Accounting Standards No. 141,
Business Combinations,
we have allocated the total purchase price to tangible and identifiable intangible assets acquired
and liabilities assumed based on their estimated fair values. The allocation of the purchase price
is described in our consolidated financial statements which are incorporated into this document by
reference. The fair values assigned to identifiable intangible assets
acquired were based on management's estimates and assumptions of
their fair values. The fair values of the non-compete agreements, customer relationships and trade name
and logo of JPI were determined using an income approach and discounted cash flow techniques.
Our Products and Regulatory Approval
To date, we have not generated significant revenue from the sale of our proprietary or
non-proprietary products. We develop and sell our DR-70
®
immunoassay test for
the detection and monitoring of cancer outside the U.S., and we are a U.S. OEM for non-invasive and
non-therapeutic diagnostic blood and urine products test kits.
Our products, to the extent they may be deemed medical devices or biologics, are governed by
the U.S. Food, Drug and Cosmetics Act and by the regulations promulgated there under by the USFDA
as well as the regulations of state agencies and various foreign governmental agencies in the
jurisdictions where our products are distributed. We (or our distributors) are required in the
U.S. and in foreign countries to obtain approval from those countries regulatory authorities
before we can market and sell our products in those countries. Obtaining regulatory approval is
costly and may take many years, and after it is obtained, it remains costly to maintain. The USFDA
and foreign regulatory agencies have substantial discretion to terminate clinical trials, require
additional testing, delay or withhold registration and marketing approval and mandate product
withdrawals. In addition, later discovery of unknown problems with our products or manufacturing
processes could result in restrictions on such products and manufacturing processes, including
potential withdrawal of the products from the market. If regulatory authorities determine that we
have violated regulations or if they restrict, suspend or revoke our prior approvals, they could
prohibit us from manufacturing or selling our products until we comply, or indefinitely.
4
DR-70
®
DR-70
®
is our proprietary diagnostic test kit which has been shown to
detect at least 14 different common cancers, including, but not limited to: lung (small and
non-small cell); stomach; breast; rectal; colon; and liver cancer. DR-70
®
is a
tumor-marker, which is a biochemical substance indicative of neoplasia, potentially specific,
sensitive, and proportional to tumor load, used to screen, diagnose, assess prognosis, follow
response to treatment, and monitor for recurrence. As DR-70
®
is a non-invasive
blood test, there are no side effects of the administration of the test. As with other cancer
diagnostic products, false positive and false negative test results could pose a small risk to
patient health if their physician is not vigilant in following up on the DR-70
®
test results with other clinically relevant diagnostic modalities.
DR-70
®
is subject to specific USFDA rules applicable to in vitro diagnostic (IVD)
products. Prior to marketing DR-70
®
in the U.S., we are required to make a pre-market
application as an immunology and microbiology device under the category Tumor Associated Antigens
Immunological Test System regulated as a Class II IVD device. We are required to prove the safety
and efficacy of the products and to comply with specified labeling requirements for IVD products
for human use. We must abide by the listing rules of the USFDA when and if DR-70
®
is
approved for sale in the U.S. We have established our Quality System Regulation in accordance with
applicable regulations and were most recently inspected in November 2004. Our Quality System
Regulation program contains applicable complaint provisions that we believe meet the USFDAs
requirements for Medical Device Reporting and we have experienced no incidents or complaints to
date. We also have implemented procedures for preventive and corrective action and changed our
packing and shipping method once in 2002 to improve protection of our product.
In addition, each foreign jurisdiction may have separate and different approval requirements
and processes. Our distribution agreements require our distributors to obtain the requisite
approval and clearance in each jurisdiction in which they sell products. In our experience, once a
foreign approval is obtained, it is generally renewed on a periodic basis, annually or otherwise.
In certain territories, distributors can sell under limited circumstances prior to approval and in
other territories no formal approval is required. On December 20, 2000, the Medical Devices Agency
of United Kingdom Department of Health issued a letter of no objection to the exportation of our
DR-70
®
from the U.S. to the United Kingdom, allowing DR-70
®
to be sold in the
United Kingdom. In late 2006, Mercy Bio Technology Co., Ltd., our distributor in Taiwan, received
Department of Health approval to market DR-70
®
in Taiwan. We have also received
regulatory approval to market DR-70
®
in South Korea and import and market
DR-70
®
in Australia. In Canada, DR-70
®
is approved as a
screening device for lung cancer only.
In 1993, the Cross Cancer Institute, located in Edmonton, Alberta, Canada, approved a clinical
trial protocol for DR-70
®
for lung cancer under the auspices of the Alberta
Cancer Board. The objective of the clinical trial at the Cross Cancer Institute was to evaluate
the sensitivity and specificity of the DR-70
®
lung cancer tumor-marker and to
determine if the level of the tumor-marker correlates with the stage of lung cancer development.
In the Cross Cancer Institute clinical trial, 233 patients with newly diagnosed lung cancer and 238
volunteers with no clinical evidence of disease were selected. The DR-70
®
tumor-marker was measured in blood serum samples collected from both cancer patients and
volunteers. The control group was composed of smokers and non-smokers. The results showed
sensitivity of the lung cancer test was 67% and specificity was 91%. We believe these results,
coupled with data reported in continued studies at the Cross Cancer Institute, demonstrate the
value of the DR-70
®
lung cancer tumor-marker as a diagnostic test for detecting
lung cancer. These tests also helped determine the usefulness of DR-70
®
for
monitoring response to treatment and for predicting the recurrence of lung cancer. The test is
currently available and approved for lung cancer detection and monitoring by Health Canada.
In 1997, clinical studies using DR-70
®
were conducted in Wuhan, China. The results of these
studies have been published in the peer-reviewed Journal of Immunoassay, among others. These
studies
5
determined that the DR-70
®
immunoassay kit detected a number of different
cancers, in addition to lung cancer. The researchers who performed these studies did note that
false positive results were possible for the DR-70
®
immunoassay, much like
other cancer detection tests, due to other conditions affecting the patient, e.g., pregnancy or
recent trauma. In these clinical trials, DR-70
®
was found to have an overall
specificity of 95% and an overall sensitivity of 84%. Thirteen different types of cancer were
found in the screening process, indicating that DR-70
®
has significant usefulness as a
cancer-screening tool. In late 2001, the study was expanded to include more than 700 patients and
the results of this expanded study confirmed the previously published results while providing a
broader statistical base. In May 2003, at a meeting of the American Gastroenterology Society in
Orlando, Florida, clinical studies were presented using DR-70
®
at the
University of Frankfurt to detect colorectal cancer. Samples were taken from 85 gastrointestinal
patients, including 29 patients with hepatocellular cancer, 13 with pancreatic cancer, 30 with
colorectal cancer, 10 with stomach cancer and 3 with esophageal cancer. In these tests,
DR-70
®
was found to have an overall specificity of 93% and an overall
sensitivity of 91%. In November 2004, the results of the study were published in the
gastroenterology journal, Alimentary Pharmacology & Therapeutics. The data for these trials
indicated that patients with advanced tumors exhibited significantly higher
DR-70
®
values than those with early-stage tumors. The authors concluded that
the DR-70
®
immunoassay reliably differs between cancer patients and healthy
controls. In November 2004, researchers at Wuhan University in China performed a clinical trial to
evaluate the diagnostic value of the DR-70
®
immunoassay for the detection of
tongue cancers. In 2005, the results of the Wuhan University oral cancer trial were published in
the British Journal of Oral and Maxillofacial Surgery. These researchers concluded that the serum
concentrations of our DR-70
®
immunoassay were significantly higher in patients
with malignant disease, than in either the benign or healthy control groups. In addition, the
concentration of the DR-70
®
immunoassay in serum correlated significantly with
3-year survival.
In 2001, we released a modified DR-70
®
test and the clinical testing of the
modified test kit was performed in Germany. Studies completed at the University of Frankfurt have
shown DR-70
®
to be a reliable screening test for cancer of the gastrointestinal tract.
An ovarian study was published in the January 2006
German Journal of Obstetrics and Gynecology
.
The German ovarian cancer study demonstrated that the sensitivity of DR-70
®
was 13.1%
higher than CA-125 for the patients included in the study.
In May 2002, we conducted clinical trials using samples obtained from patients at sites in
Texas and Florida. In these monitoring trials, we compared the DR-70
®
values with the
currently accepted assay, Carcinoembryonic Antigen (CEA), at each patient visit in the serial set
of monitoring visits. In September 2003, we submitted our first 510(k) application to the USFDA to
obtain a premarket approval for the DR-70
®
test as a Class II regulated IVD device.
According to the USFDA, a 510(k) is a premarket submission made to USFDA to demonstrate that the
device to be marketed is at least as safe and effective, that is, substantially equivalent, to a
legally marketed device that is not subject to a premarket approval. As submitters of the
application, we must compare our device to one or more similar legally marketed devices and make
and support our substantial equivalence claims.In this 510(k) application, we attempted
to demonstrate that the DR-70
®
test is at least as safe and effective, that is,
substantially equivalent, to the legally marketed predicate device, CEA. In this 510(k)
application, our intended use for the DR-70
®
immunoassay was as an aid in monitoring
patients with colorectal cancer. In January 2004, the USFDA responded to our submission. The
USFDA identified deficiencies in our application and the USFDA advised our consultant, Diagnostic
Oncology CRO, Inc. (DOCRO) that based upon the data submitted, the USFDA determined that the
DR-70
®
kit was not substantially equivalent to any other device that has gone through
the 510(k) approval process. The USFDA further advised that if we had data showing that the
DR-70
®
kit has substantial equivalence, we could submit such additional information for
the USFDAs consideration.
In January 2005, DOCRO supplied additional data in the form of a new 510(k) application to the
USFDA proposing that DR-70
®
be used in tandem with CEA in monitoring colorectal cancer
patients. In June 2005, the USFDA issued a non-substantially equivalence letter and pointed out
several areas of concern regarding the new application for use of DR-70
®
as an
adjunctive test with CEA. In 2006, we
6
explored the use of a modified intended use statement in a potential third 510(k) proposal.
The statistical evidence derived from these alternative trials was not statistically significant.
On November 28, 2006, we submitted a Pre-IDE document to the USFDA, which established our
intent to submit a third 510(k) application in support of the DR-70
®
immunoassay. The Pre-IDE document in support of the DR-70
®
immunoassay
described the unusual regulatory strategy approach that we intended to pursue. On January 25,
2007, we met with the USFDA to support our Pre-IDE document that included a new introduction,
literature review, our proposed regulatory strategy and detailed characterization studies of the
capture antibody, detection antibody, antigen measured in colorectal serum and other information.
On February 28, 2007, the USFDA sent a Pre-IDE review letter in response to our Pre-IDE Application
and the Pre-IDE meeting in January 2007. In the USFDAs Pre-IDE review letter, they listed 37
areas of concern. On May 17, 2007, we responded to each of USFDAs areas of concern. On September
13, 2007, USFDA sent a response letter to our May 2007 response letter in which they listed four
major areas of concern. On October 5, 2007, we submitted our third 510(k) application in support
of the DR-70
®
immunoassay with the following intended use claim: Testing using
the AMDL-ELISA DR-70
®
(FDP) is to be used as an aid in monitoring the
progression of patients who have been previously diagnosed with colorectal cancer. Results of
DR-70
®
FDP testing should be used in conjunction with other clinical modalities
that are standard of care for monitoring disease progression in these patients. On November 13,
2007, we received a letter of deficiency noting four areas of concern in our application and our
application was put on hold pending the USFDAs receipt of our responses to its concerns. We were
granted a 180-day extension to May 12, 2008 to respond in full to the USFDAs concerns. We intend
to respond to the USFDAs concerns by that deadline. We cannot predict the length of time it will
take for the USFDA to review this responsive documentation or whether premarket approval will
ultimately be obtained. Accordingly, we are subject to the risk of failure to maintain our
existing regulatory approvals, and in obtaining the USFDA regulatory approval of DR-70
®
,
as well as the uncertainty and delay until receipt of such approval, if obtained. Therefore, we
are subject to substantial business risks and uncertainties inherent therein, including the
potential of business failure.
JPI submitted an application to the SFDA for approval to market the DR-70
®
test kit
in China. The SFDA has begun the approval process with the DR-70
®
test kit undergoing
standard product review by the Beijing Institute of Medical Device Quality Supervision and
Inspection Center.
In June 2007, the Chinese approval process fundamentally changed. Under the new SFDA guidelines, the SFDA is unlikely
to approve the marketing of DR-70
®
without one of the following: approval by the USFDA, sufficient clinical trials in China, or
product approval from a country where DR-70
®
is registered and approved for marketing and export. JPI intends to proceed with
all of these options in an attempt to meet the new SFDA guidelines, but, there can be no assurances that JPI will obtain approval
for DR-70
®
or what the timing thereof may be.
Our Combination Immunogene Therapy
In August 2001, we acquired a combination immunogene therapy technology that may be effective
in building a cancer patients immune system and could eventually lead to a vaccine to protect
patients known to be at risk because of a family history for certain types of cancer. The
combination immunogene therapy is intended to build the bodys immune system and destroy cancer
cells. This technology involves injecting the cancer patients tumor with a vector carrying both a
granulocyte-macrophage colony stimulating factor and a t-cell co-stimulating factor, thereby
activating an immune response against the cancer cells. We are actively seeking a pharmaceutical
or biotechnology strategic partner with whom to form a joint venture or otherwise license our
combination immunogene therapy technology.
Preliminary tests in Canada conducted on mice injected with human skin and brain cancers
indicated that the combination immunogene therapy can be effective. Additionally, Phase 1 clinical
trials
7
have been completed in Canada. We funded a study conducted by Dr. Lung-Ji Chang at the
University of Florida to target breast cancer with a goal of ultimately developing a vaccine using
the combination immunogene therapy technology. We believe the technology may have potential for
fighting several types of cancer by enhancing ones immune system, thereby increasing the number of
cells that naturally destroy cancer. We also acquired from Dr. Chang other technology relating to
a humanized mouse model for the evaluation of anti-human tumor immunity and the identification of
immuno-modulating genes. We are not currently conducting any trials using our combination
immunogene therapy technology. No assurances can be given that any of these activities will lead
to the development of any commercial products or vaccines or that USFDA approval will be obtained
for any use of our immunogene therapy technology.
On February 22, 2002, AcuVector Group, Inc. (AcuVector) filed a Statement of Claim in the
Court of Queens Bench of Alberta, Judicial District of Edmonton, Canada relating to our
combination immunogene therapy technology acquired from Dr. Chang in August 2001. AcuVector, a
former licensee of Dr. Chang, claims that the terminated license agreement is still in effect.
AcuVector is seeking substantial damages and injunctive relief against Dr. Chang and CDN$20,000,000
in damages against us for alleged interference with the relationship between Dr. Chang and
AcuVector. The claim for injunctive relief seeks to establish that the AcuVector license agreement
with Dr. Chang is still in effect. We performed sufficient due diligence at the time we acquired
the technology to permit us to conclude that AcuVector had no interest in the technology when we
acquired it. Although the case is still in the early stages of discovery, we believe that
AcuVectors claims are without merit and that we will receive a favorable judgment.
We are also defending a companion case filed in the same court by the Governors of the
University of Alberta against us and Dr. Chang. The University of Alberta claims, among other
things, that Dr. Chang failed to remit the payment of the Universitys portion of the monies we
paid to Dr. Chang for the combination immunogene therapy technology we purchased from Dr. Chang in
2001. In addition to other claims against Dr. Chang relating to other technologies developed by
him while at the University, the University also claims that we conspired with Dr. Chang and
interfered with the Universitys contractual relations under certain agreements with Dr. Chang,
thereby damaging the University in an amount which is unknown to the University at this time. The
University has not claimed that we are not the owner of the combination immunogene therapy
technology, just that the University has an equitable interest therein or the revenues therefrom.
Accordingly, if either AcuVector or the University is successful in their claims, we may be
liable for substantial damages, our rights to the technology will be adversely affected, and our
future prospects for exploiting or licensing the combination immunogene therapy technology will be
significantly impaired. However, since the final outcome of either case is not determinable, no
accrual or loss relating to either action is reflected in our accompanying consolidated financial
statements.
Pylori-Probe
Our other proprietary product, Pylori-Probe, is cleared for sale in the U.S.; however, we do
not intend to market Pylori-Probe because another non-invasive test exists.
OEM Products
Our OEM tests include non-invasive and non-therapeutic diagnostic blood tests. Our OEM
product test kits are similar, if not substantially the same, as those offered by others. Our OEM
products have been registered by their respective manufacturers. We purchase these products from
the manufacturer and resell them under our label. We do not have any exclusive or nonexclusive
rights to the technology relating to the OEM products.
8
Historically, our primary OEM product was a keytone strip that was used by diabetics and those
on high protein diets to monitor keytones. Keytone levels, if elevated, are associated with kidney
damage in many patients. Sales of OEM products have been declining for the past few years. Since
the acquisition of JPI, sales of our OEM products represent an insignificant portion of our total
sales. Our line of OEM products currently includes diagnostic test kits for autoimmune and cancer
markers.
We also offer a line of non-proprietary blood tests that are designed to help diagnose a
particular kind of cancer. These tests are generally known by the symbols that denote the type of
cancer, e.g., CEA for colon cancer and PSA for prostate cancer.
Our Strategy
We develop, manufacture and offer for sale non-invasive diagnostic kits to hospitals, doctors,
clinics, and laboratories, giving them the ability to detect certain types of cancer in their
patients. Our kits are designed to provide accuracy, reproducibility and a high degree of
specificity and sensitivity.
We continue to conduct quality assurance and quality control testing on our DR-70
®
product as part of our commitment to quality and to meet government regulations. We are seeking to
create alliances with reference laboratories to make DR-70
®
testing available to
physicians and patients. With just a small amount of blood serum drawn from a patient,
DR-70
®
uses a common micro titer format familiar to most laboratories in the diagnostic
industry to test for the presence of tumors. The DR-70
®
product is capable of detecting
different types of cancer with little or no discomfort to patients. A positive diagnosis of cancer
based on screening with the DR-70
®
test must be followed with additional diagnostic
tests to determine which of the at least 13 different kinds of cancer have been detected in each
patient. DR-70
®
test levels may increase with the progression and stage of the disease.
Our objective is to combine our cancer detection and combination immunogene therapy vaccine
technologies with JPIs China-based pharmaceutical manufacturing, consumer sales and clinical
trials expertise to build a global healthcare enterprise.
In order to meet our objectives, we plan to do the following:
|
|
|
obtain USFDA and SFDA clearance and international approvals for our
DR-70
®
product;
|
|
|
|
|
expand JPIs business through new distribution channels, including, but not limited
to the JPGreen Clinics;
|
|
|
|
|
distribute greater quantities of DR-70
®
kits in approved markets;
|
|
|
|
|
develop DR-70
®
distribution channels in new markets;
|
|
|
|
|
pursue one or more strategic partners to license and develop our combination
immunogene therapy technology;
|
|
|
|
|
in-license North American drugs for manufacture and sales in China and Asia;
JPI has signed a memorandum of understanding with Bio-Health Technology Inc. (BTI) to
act as their sole manufacturer of PROVIN-C. In February of 2008, JPI assisted BTI in
setting up their representative office in Beijing. JPI will submit an application to
the SFDA for approval to market PROVIN-C which we hope will be completed by the end of
2009, although there can be no assurance that such application will
be approved at that
time, if at all; and
|
|
|
|
|
fully utilize our Chinese Good Manufacturing Practices (GMP) recognition
manufacturing facilities to foster worldwide sales of existing and to-be developed
products.
|
9
Successful cancer detection and treatment product development is highly uncertain, and very
few research and development projects produce a commercial product. Product candidates like
DR-70
®
or the combination immunogene therapy technology that appear promising in the
early phases of development, such as in early animal or human clinical trials, may fail to reach
the market for any one of a number of reasons, such as:
|
|
|
the product candidate did not demonstrate acceptable clinical trial results
even though it demonstrated positive preclinical trial results;
|
|
|
|
|
the product candidate was not effective in treating a specified condition or
illness;
|
|
|
|
|
the product candidate had harmful side effects on humans;
|
|
|
|
|
the necessary regulatory bodies, such as the USFDA, did not approve the product
candidate for an intended use;
|
|
|
|
|
the product candidate was not economical for us to manufacture and
commercialize; and
|
|
|
|
|
the product candidate is not cost effective in light of existing therapeutics.
|
There may be other factors that prevent us from marketing a product. Our products compete
with other products or treatments for diseases for which our product may be intended. We cannot
guarantee we will be able to produce commercially successful products, and to date,
DR-70
®
has not been approved for sale in the U.S. by the USFDA or in China by the SFDA.
Further, clinical trial results are frequently susceptible to varying interpretations by
scientists, medical personnel, regulatory personnel, statisticians and others, which may delay,
limit or prevent further clinical development or regulatory approvals of a product candidate.
Also, the length of time that it would take for us to complete clinical trials and obtain
regulatory approval for product marketing may vary by product and by the intended use of a product.
We cannot predict the length of time it would take to complete necessary clinical trials and
obtain regulatory approval in either the U.S. or China.
Sales and Marketing
Currently, our efforts are focused on expanding JPIs business in China, as we do not have
USFDA approval to market DR-70
®
in the U.S. A significant amount of our recent
financings have been used to: (i) renovate JJBs manufacturing facilities; (ii) develop additional
distribution channels for JJB and YYBs existing products; and (iii) investigate and develop or
license new products that can be distributed in China. We are also seeking additional exclusive
and non-exclusive distribution agreements with distributors in countries where we have obtained, or
believe we can obtain, regulatory approval.
We continue to offer OEM or private label test kits to under-served international markets
through distributor relationships and to domestic markets through strategic partnerships and
relationships with larger diagnostic companies, but do not engage in extensive marketing activities
to generate sales of our OEM products. However, we use the internet, select journals, and industry
trade shows for our limited marketing activities.
Manufacturing
We manufacture our DR-70
®
kits at our licensed manufacturing facility located at
2492 Walnut Avenue, Suite 100, in Tustin, California. We are an USFDA/GMP approved manufacturing
facility. We maintain a current Device Manufacturing License issued by the State of California,
Department of Health Services, Food and Drug Branch.
10
In December 2003, our facilities in Tustin, California became CE compliant. Our
DR-70
®
kit conforms to the essential requirements of the CE Mark, which is required to
sell our product in the European Union (EU). The CE Mark is recognized around the world as an
indication of quality practices and is referred to as the Trade Passport to Europe for non-EU
products. As of January 2004 we became EN ISO 1345 compliant, which is important for sales
internationally.
In 2004, the USFDA inspected our facilities and found no deficiencies. Six observations were
made and the USFDAs suggestions were implemented. We were found to be compliant with USFDA
Regulations. All of our OEM products are Class I (GMP not required) or Class II (GMP required, as
defined by the USFDA guidelines) devices and our facilities meet the GMP requirements for each of
our OEM products. We are licensed to manufacture our proprietary products and to repackage our OEM
products at our Tustin location.
Our Patents
Our success depends, in part, on our ability to obtain U.S. and foreign patent protection for
our products, preserve our trade secrets, and operate without infringing upon the proprietary
rights of third parties. The U.S. Patent and Trademark Office has issued to us two patents which
describe methods for measuring ring-shaped particles in extra-cellular fluid as a means for
detecting cancer. Our patent for a method of detecting the tumors using ring shaped particles as a
tumor marker was issued on October 17, 1995 and expires on October 17, 2012. Our patent for a
method for detecting the presence of ring shaped particles as tumor markers was issued on June 3,
1997 and expires on June 3, 2014. We have three additional patent applications pending in the U.S.
with respect to our methodology for the DR-70
®
tumor-markers as reliable indicators of
the presence of cancer. In addition, we have one patent based on our methodology for the
DR-70
®
tumor marker pending in Europe.
In August 2001, we acquired intellectual property rights and an assignment of a U.S. patent
application covering a combination immunogene therapy technology for $2,000,000. The technology
was purchased from Dr. Lung-Ji Chang, who developed it while at the University of Alberta,
Edmonton, Canada. A U.S. patent was issued on May 4, 2004, expires on April 9, 2017, and claims a
gene therapy method for treating cancer using an expression vector comprising a gene encoding the
B7-2 protein in combination with an additional modulating protein, GMCSF. In 2004, we also filed a
continuation patent application on the immunogene therapy technology.
On November 21, 2001, Singapore granted our patent containing claims to the combination
immunogene therapy technology. Singapore is a registration only jurisdiction, which means that
patent applications are not substantively reviewed prior to grant. However, the patent is
enforceable in Singapore, but the validity of such patents is determined by their courts. In
November 2006, we were issued a patent in Australia on our CIT technology claims covering the gene
therapy method for treating cancer using an expression vector comprising a gene encoding the B7-2
protein in combination with an additional modulating protein.
In early 2003, Australia granted us a patent for our humanized mouse model technology acquired
from Dr. Chang. This technology is a research tool suitable for the evaluation of anti-human tumor
immunity and the identification of immuno-modulating genes. In March 2007, Israel granted us a
patent for our humanized mouse model. Patents that are based on the humanized mouse model are
pending in the following countries: Canada, Europe, Japan, and Singapore.
On June 19, 2001, a U.S. patent was issued on a technology for evaluation of vaccines in
animals which was also acquired from Dr. Chang. This patent expires on December 25, 2017.
There can be no assurance however, that any additional patents will be issued to us, or that,
if issued, the breadth or degree of protection of these patents will be adequate to protect our
interests. In addition, there can be no assurance that others will not independently develop
substantially equivalent
11
proprietary information or obtain access to our know-how. Further, there can be no assurance
that others will not be issued patents which may prevent the sale of our test kits or require
licensing and the payment of significant fees or royalties by us in order for us to be able to
carry on our business. Finally, there can be no guarantee that any patents issued to or licensed
by us will not be infringed by the products of others. Defense and prosecution of patent claims
can be expensive and time consuming, even in those instances in which the outcome is favorable to
us. If the outcome is adverse, it could subject us to significant liabilities to third parties,
require us to obtain licenses from third parties or require us to cease research and development
activities or sales.
Research and Development on DR-70
®
During the years ended December 31, 2007 and 2006, we spent $28,628 and $395,964,
respectively, on research and development costs related to DR-70
®
for the USFDA and SFDA
applications for approval of DR-70
®
.
Competition
We have only had limited sales of DR-70
®
to our distributors. We are dependent on
our distributors financial ability to advertise and market DR-70
®
in those countries
where we have distributors. A number of domestic and international companies are in indirect
competition with us in all of these markets. Most of these companies are larger, more firmly
established, have significant marketing and development budgets and have greater capital resources
than us or our distributors. Therefore, there can be no assurance that we will be able to achieve
and maintain a competitive position in the diagnostic test industry.
Many major medical device manufacturers, including Abbott Diagnostics, Baxter Healthcare
Corp., Beckman Diagnostics, Boehringer Mannheim, Centocor, Diagnostic Products Corporation, Bio-Rad
Laboratories, Roche Diagnostic Systems, Sigma Diagnostics and others, are manufacturers or
marketers of other diagnostic products. We are not aware of any efforts currently being devoted to
development of products such as DR-70
®
; however, there can be no assurance that such
efforts are not being undertaken without our knowledge. We believe that most of the diagnostic
products currently manufactured by other companies are complementary to DR-70
®
.
Moreover, such companies could develop products similar to our products and they may be more
successful than we may in marketing and manufacturing their products. In addition, there are a
number of new technologies in various stages of development at the National Institute of Health,
university research centers and at other companies for the detection of various types of cancers,
e.g., identification of proteomic patterns in blood serum that distinguishes benign from cancerous
conditions, which may compete with our product.
JADE PHARMACEUTICAL INC.
Overview of JPIs Business
JPI manufactures and distributes its products through two wholly-owned Chinese subsidiaries,
JJB and YYB. Historically, JJB has primarily been a manufacturer and distributor of large and
small volume injectible fluids as well as other products for external use. YYB, on the other hand,
primarily manufacturers tablets, capsules and other over-the-counter pharmaceutical products.
Sales of JPIs products are approximated to be 40% over-the-counter and 60% to hospitals and other
institutional customers.
JJBs facilities in Shangrao, Jilin Province, China are located on approximately 24 acres of
land housing its 250,000 square foot manufacturing facility. YYB is located in Tuman City, Jilin
Province, China, and operates a 150,000 square foot facility on approximately 3.45 acres of land
there.
12
The management of JJB was notified by the Chinese Military Department of its intent to annex
part of JJBs plant located near a military installation. The proposed area to be annexed contains
the facilities that are used to manufacture large and small volume parenteral solutions.
Management lodged claims against surrendering the plant to the Chinese Military Department and has
not received a response as of the date of this prospectus. If such annexation were to occur,
although we expect that JJB will be compensated fairly for the facility, JJB will may have to spend
significant time and resources finding another location and restarting those operations in another
area. In addition, such new location may need to obtain GMP certification.
JJBs GMP certification has expired for the small volume parenteral solutions injection plant
currently manufacturing Goodnak, and JJB has ceased operations at this facility while modifications
are made to the facility to bring operations in compliance. The cost of these modifications is
estimated at approximately $1,000,000 and JBB hopes to resume operations at that location by the
second quarter of 2008. There can be no assurances that the project will be within budget or that
the GMP certificate will be received by the second quarter of 2008.
Both JJB and YYB utilize the services of more than 200 small suppliers. No raw materials are
imported for their pharmaceutical manufacturing operations and no finished products are currently
exported out of China. All raw materials are stored at the facilities and neither JJB nor YYB has
experienced any difficulty in obtaining raw materials for their manufacturing operations.
JJB has 57 production licenses for large volume injection fluids, small volume injection
fluids, tablets and tinctures and related products.
JJBs primary products in the large volume injectible category are: Glucose injection;
Glucose and Sodium Chloride injection; Sodium Chloride injection; Metroniadazole injection;
Metroniadazole and Glucose injection; Destran 40 Glucose injection; and Heartleaf Houttuynia Herb
Extracts injection. JJBs facility has the capability to produce up to 18 million bottles of large
volume injection fluids annually.
JJBs primary products in the small volume injectible category are: Human Placental Extracts
injection; Heartleaf Houttuynia Herb Extracts injection; Chrondroitin Sulfate injection; Amikacin
Sulfate injection; Muscle injection; Glucose injection; Ribavirin injection; and Gentamycin Sulfate
injection. JJBs facility has the ability to produce 70 million bottles of small volume injection
fluids annually.
JJBs primary products in the tablet category are: Metroniadazole tablets; Domperidone
tablets; Piracetam tablets; Inosine tablets; Oryzanol tablets; compound Benzoic Acid tablets; and
Camphor Solution tablets. JJBs facility has the ability to produce 1.5 billion tablets annually.
JJB has licenses for tinctures and the principal product is compound Benzoic Acid.
JJB has no significant licensing, royalty or other similar agreements or labor contracts other
than standard individual employments contracts with all of JJBs employees, which is customary in
China.
In 2007, JJB introduced a number of new products including Ondansetron Hydrochloride,
Domperidone tablets, levofloxacin tablets and Goodnak injectible solutions. Commencing in
September 2007, JJB began selling Goodnak, an anti-aging skin care product containing human
placental solutions. Goodnak is currently sold in liquid injectible solutions; but, eventually JJB
intends also to offer Goodnak in capsules, sprays and creams to a chain of eight existing and
200-to-be-established JPGreen Health and Beauty Clinics through a newly formed WFOE controlled by
our Hong Kong subsidiary. JJBs facility is currently unable to manufacture Goodnak, but will
resume doing so when the facility becomes GMP re-certified.
13
Among other products, during the first half of 2008, JJB expects to also manufacture and
distribute Omeprazole sodium injectible solutions, Balolloxacin tablets, Prulifloxacin tablets,
Lomefloxacin Aspartate injectible solutions and Roxethromycin tablets.
YYB has 86 product licenses. The following is a list of YYBs principal products: Gu Yian
Ling Pian; Diaitamin Calcium Hydrogen Phosphate and Lysine tablets; Compound Gentian and Sodium
Bicarbonate tablets; Compound Paracetamol and Amantadine Hydrochloride capsules; Bear Bile tablets;
Promethazine and Bile tablets; Compound Declofenac Sodium and Chlorphenamine Maleate tablets;
Paracetamol Caffeine
;
Artificial Cow bezoar and Chlorphenamine Maleate tablets; Paracetamol
Caffeine; Artificial Cow-bezoar and Chlorphenamine Maleate capsules; Trivitamin and Calcium
Gluconate Calcium Hydrogen Phosphate chewable tablets; Calcium Hydrogen Phosphate chewable tablets;
Fenbufen capsules; Nan Bao capsules, Rhizoma Gastrodiane capsules; and Bererine Hydrochloride
tablets. YYBs plant facility was renovated and new manufacturing facilities were completed in
July 2005. YYBs facilities have the capacity to produce more than an aggregate of one billion
tablets and capsules per year.
Currently, although both JJB and YYB have approximately 140 product licenses, only eight
products significantly contribute to JPIs sales. For the year ended December 31, 2007, the top
selling JPI products (unaudited) were as follows:
|
|
|
|
|
|
|
Sales $
|
Product
|
|
(rounded)
|
Domperidone Tablet
|
|
$
|
5,230,300
|
|
Human Placental Histosolution (GOODNAK)
|
|
|
3,706,400
|
|
Diavitamin, Calcium Hydrogen Phosphate and Lysine Tablets
|
|
|
1,420,500
|
|
Levofloxacin Lactate and Sodium Chloride Injection
(concentration)
|
|
|
570,800
|
|
Glucose Injectible Solution (250 ml Bottle)
|
|
|
480,140
|
|
GuYanLin Tablet
|
|
|
470,490
|
|
50% Glucose Injectible Solution (20 mls Amp)
|
|
|
416,980
|
|
Glucose Injectible Solution (500 ml Bottle)
|
|
|
295,700
|
|
Human Placental Histosolution
|
|
|
241,350
|
|
Compound Benzoic Acid and Camphor Solution I
|
|
|
193,250
|
|
Total
|
|
$
|
13,025,910
|
|
Of the foregoing, approximately 40% were over-the-counter sales and 60% were sales to
distributors.
JJB is expected to release the following products in 2008:
|
|
|
|
|
Name of Product
|
|
Use
|
|
Sale Commencement Date
|
Epinastine Tablets
|
|
Allergy
|
|
3
rd
Quarter of 2008
|
Pidotimod Tablets
|
|
Anti-Aging
|
|
3
rd
Quarter of 2008
|
Creatine Phosphate Sodium Injectible
|
|
Heart/Angina
|
|
3
rd
Quarter of 2008
|
Doxtaxel
|
|
Cancer
|
|
3
rd
Quarter of 2008
|
Chinese Strategy
General
JPI is attempting to establish distribution agreements with large pharmaceutical distributors
in the larger cities and provinces in China. See Distribution Agreements below. JPI and its
subsidiaries are also developing new products for distribution in China to complement JJB and YYBs
injectible solutions, tablets and capsules. Currently DR-70
®
and Docetaxel Injections
are products that have been
14
submitted to the SFDA for approval to manufacture and sell in China. JPI expects that sale of
Goodnak and other anti-aging and skin care products through existing distribution channels and
through to-be-opened JPGreen Health and Beauty Centers will
significantly boost sales and profit
margins in 2008. The market for over-the-counter pharmaceuticals in China is estimated to be
growing at a rate of 30% each year and with Chinas large population base, China is believed to be
the fastest growing market in the world for pharmaceuticals and health care products.
Distribution Agreements
Eleven exclusive, one year renewable Distribution and Agency Agreements were signed with JJB
by distributors in third quarter of 2007. These eleven new agreements are specifically for JJBs
new Polypeptide Injection product. These new contracts cover eleven provinces that are located in
four distinct regions:
|
|
|
|
|
|
|
Northern:
|
|
Liaoning and Heilongjiang Provinces
|
|
|
Southern:
|
|
Hunnan, Zehejiang and Fujian Provinces
|
|
|
Western:
|
|
Shanxi, Xinjiang and Gansu Provinces
|
|
|
Central:
|
|
Henan, Sichuan and Guizhou Provinces
|
These eleven new agreements cover cities in provinces that have a combined population of
approximately 376.4 million people. These eleven separate agreements in combination require these
new distributors to purchase a minimum of $24,117,171 of JJBs new Polypeptide Injection product
during the one year period of the agreements and minimum initial order of $13,762,977. As of
December 31, 2007, the distributors purchased approximately 70% of their commitments.
In 2006, JJB executed a Memorandum of Understanding (MOU) with Jiangxi Baikang Medicine Co.,
Ltd. (JBM) for a distribution arrangement for product distribution in China of various existing
and to-be-developed JJB products. As part of the initial phase, JBM transferred the product
license and manufacturing licenses of four new drugs, including Marine and Sodium Chloride
Injection, Lomefloxacin Aspartate Injection, Lysine Hydrochloride Glucose Injection and Omeprazole
Sodium for injection) and two generic drugs (including Roxithromycin capsule and Levofloxacin
capsule) to JBM. Due to the change in the approval process by the SFDA, the completion of the
license transfer from JBM to JJB has been delayed. The approval is currently expected to be
granted in May 2008.
As JJB and YYBs resources permit, both JJB and YYB anticipate expanding their current
domestic Chinese distribution beyond the cities in which they currently sell through the
utilization of new distribution firms in regions currently not covered.
JPGreen Health and Beauty Centers
In order to capitalize on the Chinese interest in anti-aging products, nutritional supplements
and cosmetic products, in July 2007, JPI began direct distribution of similar products through
retail outlets owned and managed by others known as Jade Healthy Supermarkets. The Jade Healthy
Supermarkets are small retail stores operated by others who sell JPIs products at retail to
consumers. As a result of this experience, JPI has refocused these activities to concentrate on
sales to beauty clinics who could offer anti-aging clinical treatments to its clients. These
clinics are now called JPGreen Health and Beauty Clinics. There are currently eight existing
JPGreen Health and Beauty Clinics, These JPGreen locations, typically 300-900 square feet in size,
are being developed through in-house store openings and through the acquisition of existing beauty
and spa businesses. The typical JPGreen Clinic is anticipated to generate, on average,
approximately $400,000 to $700,000 in annual sales with an average net profit margin of at least
30%. Numerous existing beauty and spa businesses have indicated their interest in being acquired
and converted to JPGreen Clinics. JPI currently anticipates, assuming successful funding for this
newline of business is obtained, acquiring and converting up to 200 locations in fiscal year 2008.
15
There can be no assurance that any of the intended acquisitions are completed or that JPI will
receive the necessary funding to adequately finance the acquisition of JPGreen Clinics.
Sales, Marketing and Distribution
Sales of JJBs and YYBs products are approximately 40% over-the-counter and 60% to
institutional or hospital customers. JJB and YYB together had established a multi-level marketing
program consisting of approximately forty sales managers and approximately 1,000 sales
representatives who act as individual marketers of JJB and YYBs over-the-counter products.
Both JJB and YYB are developing educational programs for hospitals, doctors, clinics and
distributors with respect to JJB and YYBs product lines. These educational programs are intended
to improve sales and promotion of JJB and YYBs products. Both JJB and YYB sell to hospitals,
retail stores and distributors who act as agents. One primary distributor has 29 retail outlets
throughout the China. In addition, JJB and YYB have a dedicated sales team that manages its own
direct sales force and sells to retail outlets all over China.
In 2007, 82% of JPIs revenues were derived from JJBs products, 16% were from the sale of
YYBs products and 2% from other activities of JPI. The cost to manufacture most products is
approximately 50%, but the gross margins vary slightly from product to product. JPI estimates that
the gross profit on its products will be approximately 60% for 2008.
The sale of one of JJBs products, Yuxingcao, has been temporarily prohibited in China due to
safety concerns. Although JJB considers its products safe, the prohibition will remain in effect
until such time as the Chinese government determines the source of the unsafe products. The
Chinese authority has allowed the commercial sales of some Yuxingcao products in October 2006 but
not the product manufactured by JJB. None of the Yuxingcao products sold in 2006 was returned
during the nine months ended September 30, 2007. Due to the prohibition of sales of Yuxingcao
products, there were no sales of Yuxingcao for the nine months ended September 30, 2007.
Our management believes there will be no claims from customers on the sale of Yuxingcao as the
quality of the product is not an issue. It is the current policy of the relevant authorities in
China to prohibit the sales of Yuxingcao-related products. No estimate is known at this time for
the resumption of the commercial sales of Yuxingcao.
Manufacturing
The JJB facility has received three GMP Certificates, one for large volume parenteral
solutions (December 26, 2000), one for small volume parenteral solutions (January 27, 2003) and one
for tablets, tinctures and other products for external use (July 27, 2005). YYB received a GMP
Certificate for tablets, capsules and mixtures on December 3, 2004.
JJBs GMP certification has expired for the small volume parenteral solutions injection plant
currently manufacturing Goodnak. JJB has ceased operations while modifications are made to the
facility to bring operations in compliance. The estimated cost of these modifications is
approximately one million dollars and resumption of operations estimated by the second quarter of
2008.
Research and Development
In the past, JJB and YYB entered into joint research and development agreements with outside
research institutes, but all of the prior joint research agreements have expired. JJB and YYB
currently perform all of their own research and development activities on new products at their own
facilities. Currently, JJB is researching and attempting to develop a liver cancer treatment, a
bone growth stimulant and an antibiotic for the treatment of the urinary system. Each of these
products will require an additional investment of funds before these products will be available for
sale, assuming product licenses are
16
obtained for their manufacture. YYB is attempting to develop products for the treatment of
cardiovascular disease, treatments for cancer, and a healthy food series.
Competition
JJB and YYB compete with different companies in different therapeutic categories. For
example, with regard to large and small volume injection fluids, JJB primarily competes with
Jiangxi Zhuhu Pharmaceutical Company, located in Jiangxi Province, and Jiangxi Pharmaceutical
Company, located in Jiangxi Province.
The manufacture of large and small volume injection fluids, small volume injection fluids,
tablets and tinctures and related product include generics, over-the-counter and supplement
pharmacy products. There are at least 70 companies in China approved by the SFDA to manufacture
large and small volume injection fluids. JJB competes with numerous companies for distribution of
JJBs tablets as these are common over the counter pharmaceuticals. YYB completes primarily with
twenty other companies similar to YYB who are licensed to sell herbal extracts throughout China and
Asia. We share the same markets in China as American Oriental Bioengineering, Inc., Tiens Biotech
Group, China Medical Technologies and other companies. Most of these companies are larger, more
established and have significant marketing and development budgets and have greater capital
resources than we. Therefore, there can be no assurance that we will be able to achieve and
maintain a competitive position in this market.
Chinese Credit Facilities
When JPI acquired JJB and YYB, KangDa Pharmaceutical Company, a predecessor of JJB, had a
credit facility and bank loan from Industrial and Commercial Bank of China (ICBC) of
approximately $4.5 million (the KangDa Credit Facility), which was assumed by JPI. The loan from
ICBC is secured by a pledge of the real property on which our Chinese manufacturing facilities are
located. Currently, approximately $3.5 million is due and payable on the KangDa Credit Facility.
JPI is currently negotiating with ICBC to pay off the KangDa Credit Facility and to establish new
loans and credit facilities which will allow JPI to renovate its manufacturing facilities to bring
it in compliance with all Chinese GMP requirements and provide working capital to finance the
operations at up to 200 JPGreen Health and Beauty Clinics in 2008. Should negotiations with the
bank fail, JPI will require additional capital for these needs and to capitalize on other new
opportunities that may arise. The only source of these funds may be the sale of additional
securities by us, which would result in additional dilution to our current shareholders.
Chinese Regulation
Pursuant to Article 9 of the Law of China on Pharmaceutical Administration (China Law),
pharmaceutical manufacturing enterprises must organize production according to the statutory
administrative criteria on quality of pharmaceuticals formulated by the supervisory and
administrative departments in charge of pharmaceuticals of the State Council. The supervisory and
administrative departments issue a Good Manufacturing Practices Certificate to enterprises that
meet the requirements of the China Law. YYBs facility has been issued the GMP certificates
necessary to conduct the current manufacturing operations at their respective facilities. JJBs
facility has been issued GMP certificates necessary to conduct current operations except for the
small volume parenteral solutions injection plant, which facilitys GMP certificate expired in
February 2008. JJB has ceased operations of this facility while modifications are being made to
bring its operations in compliance. The estimated cost of these modifications is approximately one
million dollars and resumption of operations is currently estimated by the second quarter of 2008.
In addition, under Article 31 of China Law, each entity manufacturing pharmaceuticals must
receive the approval of the supervisory and administrative departments in charge of pharmaceuticals
of
17
the State Council and receive a serial approval number to manufacture a specific
pharmaceutical. Both JJB and YYB have product licenses to manufacture all of the products
currently being manufactured by them. Both JJB and YYB are also subject to the Food Sanitation Law
providing standards in sanitation for the consumption or injection of foods.
All new drug applications must be approved by the SFDA.
In June 2007, the Chinese approval process fundamentally changed. Under the new SFDA guidelines, the SFDA is unlikely
to approve the marketing of DR-70
®
without one of the following: approval by the USFDA, sufficient clinical trials in China, or
product approval from a country where DR-70
®
is registered and approved for marketing and export. JPI intends to proceed with
all of these options in an attempt to meet the new SFDA guidelines, but, there can be no assurances that JPI will obtain approval
for DR-70
®
or what the timing thereof may be.
RISK FACTORS
This offering involves a high degree of risk. You should consider carefully the following
risk factors, as well as the other information contained in this prospectus and the documents
incorporated by reference into this prospectus, in evaluating an investment in our common stock.
Limited product development activities; our product development efforts may not result in
commercial products.
We intend to continue to pursue USFDA and SFDA approval of DR-70
®
and licensing of
our combination immunogene therapy technology. Due to limited cash resources, we are limited in
the number of additional products we can develop at this time. Successful cancer detection and
treatment product development is highly uncertain, and very few research and development projects
produce a commercial product. Product candidates like DR-70
®
or the combination
immunogene therapy technology that appear promising in the early phases of development, such as in
early animal or human clinical trials, may fail to reach the market for a number of reasons, such
as:
|
|
|
the product candidate did not demonstrate acceptable clinical trial results
even though it demonstrated positive preclinical trial results;
|
|
|
|
|
the product candidate was not effective in treating a specified condition or
illness;
|
|
|
|
|
the product candidate had harmful side effects on humans;
|
|
|
|
|
the necessary regulatory bodies, such as the USFDA or SFDA, did not approve our
product candidate for an intended use;
|
|
|
|
|
the product candidate was not economical for us to manufacture and
commercialize; and
|
|
|
|
|
the product candidate is not cost effective in light of existing therapeutics.
|
Of course, there may be other factors that prevent us from marketing a product including, but
not limited to, our limited cash resources. We cannot guarantee we will be able to produce
commercially successful products. Further, clinical trial results are frequently susceptible to
varying interpretations by scientists, medical personnel, regulatory personnel, statisticians and
others, which may delay, limit or prevent further clinical development or regulatory approvals of a
product candidate. Also, the length of time that it takes for us to complete clinical trials and
obtain regulatory approval for product marketing may vary by product and by the intended use of a
product. We cannot predict the length of time to complete necessary clinical trials and obtain
regulatory approval.
Our cash position as of February 20, 2008 of approximately $2,835,000 is not sufficient to
conduct significant clinical trials for DR-70
®
or to market our products internationally
by ourselves. With
18
or without additional financing (or cash generated from our pharmaceutical operations in
China), we will likely engage outside distributors and license our products to others, although
there can be no assurances that our products can be successfully licensed.
Our operations in China involve significant risk.
JJB and YYB operate as WFOEs in China. Risks associated with operating as a WFOE include
unlimited liability for claims arising from operations in China and potentially less favorable
treatment from governmental agencies in China than JJB and YYB would receive if JJB and YYB
operated through a joint venture with a Chinese partner.
JJB and YYB are subject to the Pharmaceutical Administrative Law, which governs the licensing,
manufacture, marketing and distribution of pharmaceutical products in China and sets penalty
provisions for violations of provisions of the Pharmaceutical Administrative Law. Compliance with
changes in law may require us to incur additional expenditures which could have a material impact
on our consolidated financial position, results of operations and cash flows.
As in the case of JJB, the Chinese government has the right to annex or take facilities it
deems necessary. Currently, a portion of JJBs facility that produces large and small volume
parenteral solutions has been identified for annexation by the Chinese Military Department. JJB
has objected to the Chinese Military Departments annexation. The outcome of this event cannot be
predicted at this time, but if the Chinese government takes this facility, although we expect that
JJB will be compensated fairly for the facility, JJB will may have to spend significant time and
resources finding another location and restarting those operations in another area. In addition,
such new location may need to obtain GMP certification. Such annexation, or the threat of such
annexation, may negatively impact our results of operation and financial condition.
The value of the RMB fluctuates and is subject to changes in Chinas political and economic
conditions. Historically, the Chinese government has benchmarked the RMB exchange ratio against
the U.S. dollar, thereby mitigating the associated foreign currency exchange rate fluctuation risk;
however, no assurances can be given that the risks related to currency deviations of the RMB will
not increase in the future. Additionally, the RMB is not freely convertible into foreign currency
and all foreign exchange transactions must take place through authorized institutions.
We may not be able to continue to operate our business if we are unable to attract additional
operating capital.
The current level of our revenues is not sufficient to finance all of our operations on a
long-term basis. Currently, our operations do not produce sufficient cash to offset the cash drain
of the USFDA approval process for DR-70
®
and our other general operating and
administrative expenses. Accordingly, our business and operations are substantially dependent on
our ability to raise additional working capital to: (i) finance the costs of USFDA approval of
DR-70
®
in the U.S. and SFDA in China; (ii) supply additional working capital to JPI for
expansion of manufacturing capabilities for new and existing products; and (iii) fund ongoing
general and administrative expenses of our business.
At February 20, 2008, we had cash on hand of approximately $2,835,000 and cash is being
depleted at the rate of approximately $450,000 per month. Assuming (i) the current level of
revenue from the sale of DR-70
®
kits does not increase in the near future, (ii) we do
not require new cancer samples to satisfy the USFDA concerns on our pending 510(k) application,
(iii) we do not conduct any full scale clinical trials for DR-70
®
or our combination
immunogene therapy technology in the U.S. or China, (iv) JPI generates sufficient cash to meet or
exceed its cash requirements, and (v) no outstanding warrants are exercised, the amount of cash on
hand is expected to be sufficient to meet our projected operating
expenses through September, 2008.
19
As of December 31, 2007, we had warrants outstanding that are currently exercisable for up to
an aggregate of 4,528,668 shares of our common stock at a weighted-average exercise price of $4.07
per share. Included within that amount are (i) warrants to purchase a total of 367,137 shares
(including broker warrants) which were issued at an average exercise price of $5.51 per share in
our December 2006 private placement, (ii) warrants to purchase a total of 1,218,373 shares at an
average exercise price of $3.68 per share which were issued in April and May of 2007, and (iii)
warrants to purchase a total of 1,366,319 shares which were issued at an average exercise price of
$4.74 per share in our most recent private placement conducted in November 2007 and February 2008.
In addition, any future equity financing may involve substantial dilution to our stockholders.
Our
independent registered public accounting firm has included a going concern paragraph in their report on our financial
statements.
While
our independent registered public accounting firm expressed an unqualified opinion on our
consolidated financial statements,
our independent auditors did include an explanatory paragraph indicating that there is substantial
doubt about our ability to continue as a going concern due to our working capital
deficit and continuing net losses.
Our ability to continue as an operating entity currently depends, in large measure, upon our
ability to generate additional capital resources. In light of this situation, it is not likely
that we will be able to raise equity. While we seek ways to continue to operate by securing
additional financing resources or alliances or other partnership agreements, we do not at this time
have any commitments or agreements that provide for additional capital resources. Our financial
condition and the going concern emphasis paragraph may also make it more difficult for us to
maintain existing customer relationships and to initiate and secure new customer relationships.
Our current products cannot be sold in certain countries if we do not obtain and maintain
regulatory approval.
We conduct research and clinical trials and we manufacture, distribute and market our products
for their approved indications. These activities are subject to extensive regulation by numerous
state and federal governmental authorities in the U.S., such as the USFDA and the Centers for
Medicare and Medicaid Services (formerly Health Care Financing Administration) and the SFDA in
China as well as by certain foreign countries, including some in the European Union. Currently, we
(or our distributors) are required in the U.S. and in foreign countries to obtain approval from
those countries regulatory authorities before we can market and sell our products in those
countries. Obtaining regulatory approval is costly and may take many years, and after it is
obtained, it remains costly to maintain. The USFDA and foreign regulatory agencies have
substantial discretion to terminate clinical trials, require additional testing, delay or withhold
registration and marketing approval and mandate product withdrawals. In addition, later discovery
of unknown problems with our products or manufacturing processes could result in restrictions on
such products and manufacturing processes, including potential withdrawal of the products from the
market. If regulatory authorities determine that we have violated regulations or if they restrict,
suspend or revoke our prior approvals, they could prohibit us from manufacturing or selling our
products until we comply, or indefinitely.
USFDA
approval for marketing
DR-70
®
is not assured.
On November 13, 2007, we received a letter of deficiency noting four areas of concern with our
pending 510(k) application for our DR-70
®
test kit and the application was put on hold
pending the USFDAs receipt of our response to the USFDAs concerns. We were granted an extension
to May 12, 2008 to respond in full. While we intend to revise our application to address the
USFDAs concerns, the USFDAs response to the revised application cannot be anticipated and no
assurances can be given that we will ever receive USFDA clearance for the commercial sale of
DR-70
®
in the U.S. Furthermore, if USFDA approval is granted, although the approval has
no expiration date, if we are found in violation, the USFDA may impose fines, terminate the
approval or seize our products, at its discretion. In addition,
20
the loss of previously received approvals, or failure to comply with existing or future
regulatory requirements would have a material adverse effect on our business, financial condition
and results of operations.
SFDA
approval for marketing
DR-70
®
is not assured.
JPI submitted an application with the SFDA for approval to market the DR-70
®
test
kit in China. The SFDA has begun the approval process with the DR-70
®
test kit
undergoing standard product review by the Beijing Institute of Medical Device Quality Supervision
and Inspection Center. In June 2007, the Chinese approval process fundamentally changed. Under the new SFDA guidelines, the SFDA is unlikely
to approve the marketing of DR-70
®
without one of the following: approval by the USFDA, sufficient clinical trials in China, or
product approval from a country where DR-70
®
is registered and approved for marketing and export. JPI intends to proceed with
all of these options in an attempt to meet the new SFDA guidelines, but, there can be no assurances that JPI will obtain approval
for DR-70
®
or what the timing thereof may be. If SFDA approval is granted, and if we are found in
violation, the SFDA may impose fines, terminate the approval or seize our products, at its
discretion.
Our future prospects will be negatively impacted if we are unsuccessful in pending litigation over
the combination immunogene therapy technology.
As noted above, we are engaged in litigation with AcuVector and with the Governors of the
University of Alberta over our combination immunogene therapy technology. Although theses cases
are still in the early stages of discovery, we believe they are without merit and that we will
receive a favorable judgment in both. However, if either AcuVector or the University is successful
in their claims, we may be liable for substantial damages, our rights to the technology will be
adversely affected, and our future prospects for exploiting or licensing the combination immunogene
therapy technology will be significantly impaired.
The value of intangible assets may not be equal to their carrying values.
One of our intangible assets includes the combination immunogene therapy technology, which we
acquired from Dr. Chang in August 2001. We also purchased certain intangible assets in our
acquisition of JPI. Whenever events or changes in circumstances indicate that the carrying amount
may not be recoverable, we are required to evaluate the carrying value of such intangibles,
including the related amortization periods. Whenever events or changes in circumstances indicate
that the carrying value of an intangible asset may not be recoverable, we determine whether there
has been impairment by comparing the anticipated undiscounted cash flows from the operation and
eventual disposition of the product line with its carrying value. If the undiscounted cash flows
are less than the carrying value, the amount of the impairment, if any, will be determined by
comparing the carrying value of each intangible asset with its fair value. Fair value is generally
based on either a discounted cash flows analysis or market analysis. Future operating income is
based on various assumptions, including regulatory approvals, patents being granted, and the type
and nature of competing products.
Patent approval for eight original claims related to the combination immunogene therapy
technology was obtained in May 2004 and a continuation patent application was filed in 2004 for a
number of additional claims. No regulatory approval has been requested for our combination
immunogene therapy technology and we do not have the funds to conduct the clinical trials which
would be required to obtain regulatory approval for our combination immunogene therapy technology.
Accordingly, we are seeking a strategic partner to license the combination immunogene therapy
technology from us. If we cannot attract a large pharmaceutical company to license our combination
immunogene therapy technology and conduct the trials required to obtain regulatory approval, or if
regulatory approvals or patents are not obtained or are substantially delayed, or other competing
technologies are developed and obtain general market acceptance, or market conditions otherwise
change,
21
our combination immunogene therapy and other intangible technology may have a substantially
reduced value, which could be material. As intangible assets represent a substantial portion of
assets in our consolidated balance sheet, any substantial deterioration of value would
significantly impact our reported consolidated financial position and our reported consolidated
operating results.
If our intellectual property positions are challenged, invalidated or circumvented, or if we fail
to prevail in future intellectual property litigation, our business could be adversely affected.
The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and
often involve complex legal, scientific and factual questions. To date, there has emerged no
consistent policy regarding breadth of claims allowed in such companies patents. Third parties
may challenge, invalidate or circumvent our patents and patent applications relating to our
products, product candidates and technologies. In addition, our patent positions might not protect
us against competitors with similar products or technologies because competing products or
technologies may not infringe our patents.
We face substantial competition, and others may discover, develop, acquire or commercialize
products before or more successfully than we do.
We operate in a highly competitive environment. Our products compete with other products or
treatments for diseases for which our products may be indicated. Additionally, some of our
competitors market products or are actively engaged in research and development in areas where we
are developing product candidates. Large pharmaceutical corporations have greater clinical,
research, regulatory and marketing resources than we do. In addition, some of our competitors may
have technical or competitive advantages over us for the development of technologies and processes.
These resources may make it difficult for us to compete with them to successfully discover,
develop and market new products.
We have
limited sales of
DR-70
®
and are reliant on our distributors for sales of our
products.
Prior to the acquisition of JPI, virtually all of our operating revenues have come from sales
to two distributors in foreign countries of DR-70
®
kits and from sales to a few domestic
customers of our OEM products. For the year ended December 31, 2007, almost all of our revenues
were derived from sales of DR-70
®
and we had only nominal sales of our OEM products.
Historically, we have not received any substantial orders from any of our customers or distributors
of DR-70
®
or our OEM products. Moreover, none of our distributors or customers is
contractually required to buy any specific number of DR-70
®
kits or OEM products from
us. Accordingly, based upon this fact, historical sales, and the uncertainty of USFDA approval for
sale of DR-70
®
in the U.S., any projection of future orders or sales of
DR-70
®
kits or OEM products is unreliable. In addition, the amount of DR-70
®
purchased
by our distributors or customers can be adversely affected by a number of factors, including their
budget cycles and the amount of funds available to them for product promotion and marketing.
JPI is reliant on its distributors for sales of its products.
Most of JPIs products are sold to distributors. JPIs distributors are not required to
purchase any minimum quantity of products; however, many of JPIs distribution agreements are
subject to termination and cancellation if minimum quantities of specified products are not
purchased by the distributors. JPI has never terminated any distributor for failure to meet the
minimum quantity sales targets.
We are subject to risks associated with our foreign distributors.
Our business strategy includes the continued dependence on foreign distributors for our
DR-70
®
product and local distributors in China for JPIs products. To date, we have not
been successful in generating a significant increase in sales for DR-70
®
through
distribution channels in existing markets or in developing distribution channels in new markets.
We are also subject to the risks associated with our distributors operations, including: (i)
fluctuations in currency exchange rates; (ii) compliance with local
22
laws and other regulatory requirements; (iii) restrictions on the repatriation of funds; (iv)
inflationary conditions; (v) political and economic instability; (vi) war or other hostilities;
(vii) overlap of tax structures; and (viii) expropriation or nationalization of assets. The
inability to manage these and other risks effectively could adversely affect our business.
We do not intend to pay dividends on our common stock in the foreseeable future.
We currently intend to retain any earnings to support our growth strategy and do not
anticipate paying dividends in the foreseeable future.
If we fail to comply with the rules under the Sarbanes-Oxley Act related to accounting controls and
procedures or if material weaknesses or other deficiencies are discovered in our internal
accounting procedures, our stock price could decline significantly.
Section 404 of the Sarbanes-Oxley Act requires annual management assessments of the
effectiveness of our internal controls over financial reporting
commencing December 31, 2007 and a report by our independent
registered public accounting firm addressing the effectiveness of our
internal control over financial reporting for the year ending
December 31, 2008. We are required to document and test our internal control procedures. In the
course of continuing our review of the effectiveness of our internal
controls over financial
reporting as at September 30, 2007, we identified the following issues that individually or
aggregately may materially affect our internal controls of financial reporting:
|
|
|
We did not maintain effective internal control over financial reporting relating to
accurate recording and presentation of certain routine and non-routine accounting
transactions in accordance with GAAP; and
|
|
|
|
|
We did not have adequate controls to property determine and account for (i) the
contractual arrangements with ShenZhen JieKang Technologies Ltd. or (ii) our business
arrangement with Shanghai XiangEn Food Company Ltd. relating to certain retail stores.
|
In order to remediate these issues, we hired an accounting manager for Chinese operations who
is familiar with U.S. GAAP and who reports to our Chief Financial Officer. We have instituted
additional procedures for future accounting periods that will cause the transactions in China to be
reported on a timelier basis and we will continue to ensure that these transactions are recorded in
accordance with U.S. GAAP prior to consolidation. We will continue our efforts to improve or
modify our procedures and controls to provide reasonable assurance with respect to the accurate
reporting of transactions and presentation of our financial disclosures.
Notwithstanding the material weaknesses discussed above, our management has concluded that the
consolidated financial statements included in our Quarterly Report on Form 10-QSB/A for the quarter
ended September 30, 3007, and incorporated by reference into this prospectus fairly present in all
material respects our financial condition, results in operations and cash flows for the period
ended September 30, 2007 in conformity with accounting principles generally accepted in the U.S.
We may identify other material weaknesses in our internal control over financial reporting and
other deficiencies in the future. If any material weaknesses and deficiencies are detected, it
could cause investors to lose confidence in us and result in a decline in our stock price.
If we fail to achieve and maintain the adequacy of our internal controls, we may not be able
to ensure that we can conclude on an ongoing basis that we have effective internal controls over
financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act. Moreover, effective
internal controls, particularly those related to revenue recognition, are necessary for us to
produce reliable financial reports and are important to helping prevent financial fraud. If we
cannot provide reliable financial reports or prevent fraud, our business and operating results
could be harmed, investors could
23
lose confidence in our reported financial information, and the trading price of our stock
could drop significantly. In addition, we cannot be certain that additional material weaknesses or
significant deficiencies in our internal controls will not be discovered in the future.
Loss of our listing on the American Stock Exchange could adversely affect the marketability and
price of our shares.
We are not currently in compliance with the standards for continued listing on AMEX, although
AMEX has not yet taken any action to delist our securities. Unless we meet the standards for
continued listing, AMEX could at any time (i) commence a proceeding to delist our securities or
(ii) include us in the list of companies that are not in compliance with AMEXs continued listing
standards and require that the indicator .BC be added as an extension to our symbol which will be
transmitted with any quotation or trade of our shares. In June 2006, we submitted a plan to become
compliant with AMEXs continued listing standards which plan included the acquisition of JPI. The
JPI acquisition closed on September 28, 2006. On November 10, 2006 AMEX advised us that the plan
period would remain open until we have been able to demonstrate compliance with the continued
listing standards for two consecutive fiscal quarters. As of the date hereof, AMEX has not yet
issued its final letter stating that we are in compliance with the Continued Listing Standards.
Delisting from AMEX may impact our ability to raise capital in the future. The loss of listing on
AMEX could adversely affect the marketability and/or price of our shares because some brokers and
other traders might refrain from purchasing or trading our shares if we were delisted or if they
perceived that a delisting might occur in the near future. Additionally, delisting from AMEX may
adversely impact our ability to raise capital in the future.
Our stock price is volatile, which could adversely affect your investment.
Our stock price, like that of other international bio-pharma cancer diagnostic and treatment
companies, is highly volatile. Our stock price may be affected by such factors as:
|
|
|
clinical trial results;
|
|
|
|
|
product development announcements by us or our competitors;
|
|
|
|
|
regulatory matters;
|
|
|
|
|
announcements in the scientific and research community;
|
|
|
|
|
intellectual property and legal matters;
|
|
|
|
|
broader industry and market trends unrelated to our performance;
|
|
|
|
|
economic markets in Asia; and
|
|
|
|
|
competition in local Chinese markets where we sell JPIs product.
|
In addition, if our revenues or operating results in any period fail to meet the investment
communitys expectations, there could be an immediate adverse impact on our stock price.
We have limited product liability insurance.
We currently produce products for clinical studies and for investigational purposes. We are
producing our products in commercial sale quantities, which will increase as we receive various
regulatory approvals in the future. There can be no assurance, however, that users will not claim
that effects other than those intended may result from our products, including, but not limited to
claims alleged to be related to incorrect diagnoses leading to improper or lack of treatment in
reliance on test results. In the event that liability claims arise out of allegations of defects
in the design or manufacture of our products, one or more claims for damages may require the
expenditure of funds in defense of such claims or one or more substantial awards of damages against
us, and may have a material adverse effect on us by reason of our inability to defend against or
pay such claims. We carry product liability insurance
24
for any such claims, but only in an amount equal to $2,000,000 per occurrence, and $2,000,000
aggregate liability, which may be insufficient to cover all claims that may be made against us.
USE OF PROCEEDS
We will not receive any of the proceeds from sales of common stock by any selling stockholder.
We will receive gross proceeds of up to approximately $6,476,000 from the exercise of the warrants
to purchase 1,366,319 shares of our common stock if and when the warrants held by the selling
stockholders are exercised. We intend to use the proceeds from the exercise of the warrants for
our general working capital needs. There can be no assurance that all, or any, of the warrants
will be exercised. Neither the issuance of the common stock to the selling stockholders upon the
exercise of the warrants nor the transfer of the warrants is part of this offering.
DETERMINATION OF OFFERING PRICE
This offering is being made solely to allow the selling stockholders to offer and sell shares
of our common stock to the public. The selling stockholders may offer for resale some or all of
their shares at the time and price that they choose. On any given day, the price per share is
likely to be based on the bid price for our common stock, as quoted on the American Stock Exchange
on the date of sale, unless shares are sold in private transactions. Consequently, we cannot
currently make a determination of the price at which shares offered for resale pursuant to this
prospectus may be sold.
SELLING STOCKHOLDERS
This prospectus relates to the offering and sale, from time to time, of up to 4,345,257 shares
of our common stock by the stockholders named in the table below. All of the selling stockholders
named below acquired their shares of our common stock and warrants directly from us in private
transactions.
The following table sets forth certain information known to us, as of February 20, 2008, and
as adjusted to reflect the sale of the shares offered hereby, with respect to the beneficial
ownership of common stock by the selling stockholders. The selling stockholders may sell all or
some of the shares of common stock they are offering, and may sell shares of our common stock
otherwise than pursuant to this prospectus. It also assumes that each of the stockholders who have
warrants exercises all of such warrants and sells all of the shares issued upon exercise thereof.
The table below assumes that the selling stockholders sell all of the shares offered by them in
offerings pursuant to this prospectus, and neither dispose of nor acquire any additional shares.
We are unable to determine the exact number of shares that will actually be sold or when or if
these sales will occur.
25
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares beneficially
|
|
|
|
|
|
|
|
|
|
owned as of
|
|
|
Number of
|
|
|
Shares beneficially
|
|
|
|
February 20, 2008
|
|
|
shares being
|
|
|
owned after offering
(1)
|
|
Name of beneficial owner
|
|
Number
|
|
|
Percentage
|
|
|
Offered
|
|
|
Number
|
|
|
Percentage
|
|
Alpha Capital Anstalt
(2)
|
|
|
361,211
|
|
|
|
2.0
|
%
|
|
|
242,718
|
|
|
|
118,493
|
|
|
|
*
|
|
Gemini Master Fund Ltd.
(3)
|
|
|
544,484
|
|
|
|
3.4
|
%
|
|
|
240,000
|
|
|
|
304,484
|
|
|
|
1.9
|
%
|
Eisenberger Investments
(4)
|
|
|
65,946
|
|
|
|
*
|
|
|
|
33,750
|
|
|
|
32,196
|
|
|
|
*
|
|
David Herzog
(5)
|
|
|
77,500
|
|
|
|
*
|
|
|
|
52,500
|
|
|
|
25,000
|
|
|
|
*
|
|
David Herzog HPB, Inc.
|
|
|
48,750
|
|
|
|
*
|
|
|
|
48,750
|
|
|
|
0
|
|
|
|
0
|
|
Cranshire Capital, LP
(6)
|
|
|
169,047
|
|
|
|
1.1
|
%
|
|
|
150,000
|
|
|
|
19,047
|
|
|
|
*
|
|
El Coronado Holdings, LLC
(7)
|
|
|
187,500
|
|
|
|
1.27
|
%
|
|
|
187,500
|
|
|
|
0
|
|
|
|
0
|
|
MAC & CO
(8)
|
|
|
242,720
|
|
|
|
1.5
|
%
|
|
|
242,720
|
|
|
|
0
|
|
|
|
0
|
|
MidSouth Investor Fund LP
(9)
|
|
|
242,720
|
|
|
|
1.5
|
%
|
|
|
242,720
|
|
|
|
0
|
|
|
|
0
|
|
Heidtke 401(k) Profit Sharing Plan and
Trust
(10)
|
|
|
12,137
|
|
|
|
*
|
|
|
|
12,137
|
|
|
|
0
|
|
|
|
0
|
|
Lyman O. Heidtke
(11)
|
|
|
48,543
|
|
|
|
*
|
|
|
|
48,543
|
|
|
|
0
|
|
|
|
0
|
|
Momona, LLC
(12)
|
|
|
72,814
|
|
|
|
*
|
|
|
|
72,814
|
|
|
|
0
|
|
|
|
0
|
|
Alder Offshore Mansterfund LP
(13)
|
|
|
136,500
|
|
|
|
*
|
|
|
|
136,500
|
|
|
|
0
|
|
|
|
0
|
|
Alder Capital Partners I, LP
(14)
|
|
|
352,500
|
|
|
|
2.2
|
%
|
|
|
352,500
|
|
|
|
0
|
|
|
|
0
|
|
John Connors
|
|
|
22,500
|
|
|
|
*
|
|
|
|
22,500
|
|
|
|
0
|
|
|
|
0
|
|
BH Capital Investments LP
(15)
|
|
|
52,500
|
|
|
|
*
|
|
|
|
52,500
|
|
|
|
0
|
|
|
|
0
|
|
Excalibur Small-Cap Opportunities LP
(16)
|
|
|
193,500
|
|
|
|
1.2
|
%
|
|
|
193,500
|
|
|
|
0
|
|
|
|
0
|
|
Credit Suisse Client Nominees (UK) Limited FBO RAB
Special Situations (Master) Fund
Limited
(17)
|
|
|
1,080,811
|
|
|
|
6.7
|
%
|
|
|
242,718
|
|
|
|
838,093
|
|
|
|
5.2
|
%
|
Whalehaven Capital Fund Limited
(18)
|
|
|
194,175
|
|
|
|
1.2
|
%
|
|
|
194,175
|
|
|
|
0
|
|
|
|
0
|
|
Chestnut Ridge Partners, LP
(19)
|
|
|
242,718
|
|
|
|
1.5
|
%
|
|
|
242,718
|
|
|
|
0
|
|
|
|
0
|
|
Boston Financial Partners
(20)
|
|
|
509,301
|
|
|
|
3.2
|
%
|
|
|
75,000
|
|
|
|
434,301
|
|
|
|
2.7
|
%
|
First International Capital Group, Ltd.
(21)
|
|
|
644,480
|
|
|
|
4.1
|
%
|
|
|
250,000
|
|
|
|
394,480
|
|
|
|
2.5
|
%
|
Madden Consulting, Inc.
(22)
|
|
|
50,000
|
|
|
|
*
|
|
|
|
50,000
|
|
|
|
0
|
|
|
|
0
|
|
LWP1, Inc.
(23)
|
|
|
300,000
|
|
|
|
1.9
|
%
|
|
|
300,000
|
|
|
|
0
|
|
|
|
0
|
|
GreenBridge Capital Partners IV, LLC
(24)
|
|
|
485,439
|
|
|
|
3.3
|
%
|
|
|
485,439
|
|
|
|
0
|
|
|
|
0
|
|
Brighton Capital
(25)
|
|
|
19,450
|
|
|
|
*
|
|
|
|
19,450
|
|
|
|
0
|
|
|
|
0
|
|
Galileo Asset Management, S.A.
(26)
|
|
|
334,757
|
|
|
|
2.1
|
%
|
|
|
107,171
|
|
|
|
227,256
|
|
|
|
1.4
|
%
|
Spencer Clarke, LLC
(27)
|
|
|
28,160
|
|
|
|
*
|
|
|
|
28,160
|
|
|
|
0
|
|
|
|
0
|
|
Ariel Imas
|
|
|
9,387
|
|
|
|
*
|
|
|
|
9,387
|
|
|
|
0
|
|
|
|
0
|
|
Braden Anthony Ferrari
|
|
|
9,387
|
|
|
|
*
|
|
|
|
9,387
|
|
|
|
0
|
|
|
|
0
|
|
26
|
|
|
*
|
|
Less than 1%
|
|
(1)
|
|
Assumes all shares offered hereby are sold.
|
|
(2)
|
|
Konrad Ackerman, Director, has sole voting and investment power with respect to
these shares. Includes warrants to purchase 118,493 shares of common stock previously issued
and outstanding.
|
|
(3)
|
|
Gemini Strategies, LLC is the investment manager of Gemini Master Fund, Ltd. and Mr.
Steven Winters is the sole managing member of Gemini Strategies, LLC. Each of Gemini
Strategies, LLC and Mr. Winters disclaims any equitable or beneficial ownership of such
securities. Includes warrants to purchase 166,356 shares of common stock previously issued
and outstanding held by Gemini Master Fund Ltd. and warrants to purchase 138,128 shares held
by Gemini Strategies, LLC.
|
|
(4)
|
|
Stuart Eisenberger, sole owner, has sole investment and voting power over these
shares. Includes warrants to purchase 32,196 shares of common stock previously issued and
outstanding.
|
|
(5)
|
|
Includes warrants to purchase 25,000 shares of common stock previously issued and
outstanding, but does not include any shares owned by David Herzog HPB, Inc. David Herzog has
sole investment and voting power over these shares.
|
|
(6)
|
|
Mitchell R. Kopin, President of Downsview Capital, Inc., the General Partner of
Cranshire Capital, L.P. has sole voting and investment control with respect to these shares.
Includes warrants to purchase 19,047 shares of common stock previously issued and outstanding.
|
|
(7)
|
|
Josiah T. Austin, Managing Member, has sole voting and investment power with respect
to these shares.
|
|
(8)
|
|
Nominee for The Gabelli Healthcare & Wellness RX Trust, a U.S. closed-end mutual
fund (business trust).
|
|
(9)
|
|
Lyman O. Heidtke, General Partner, has sole voting and investment power with respect
to these shares. Does not include any shares held by the Heidtke 401(k) Profit Sharing Plan
and Trust or Lyman O. Heidtke, individually.
|
|
(10)
|
|
Lyman O. Heidtke, Trustee, has sole voting and investment power with respect to
these shares. Does not include any shares held by MidSouth Investor Fund LP or Lyman O.
Heidtke, individually.
|
|
(11)
|
|
Excludes shares held by MidSouth Investor Fund LP and Heidtke 401(k) Profit Sharing
Plan & Trust.
|
|
(12)
|
|
Arte Rabinowitz, Director and President, has sole voting and investment power with
respect to these shares.
|
|
(13)
|
|
Michael Licosati, President of Alder Capital LLC, has sole voting and investment
power with respect to these shares.
|
|
(14)
|
|
Michael Licosati, President of Alder Capital LLC, has sole voting and investment
power with respect to these shares.
|
|
(15)
|
|
Henry Brachfeld, President of BH Capital Investments, LP, has sole voting and
investment power with respect to these shares.
|
|
(16)
|
|
William Hecter, President of the General Partner, has sole voting and investment
power with respect to these shares.
|
|
(17)
|
|
Philip Richards, principal of RAB Special Situations (Master) Fund Limited, has
voting and investment power with respect to these shares. Includes 476,190 shares of common
stock and warrants to purchase 361,903 shares of common stock previously issued and
outstanding.
|
|
(18)
|
|
Michael Finkelstein, Investment Manager, Arthur Jones, Director, Trevor Williams,
Director, and Marco Westfield, Director, have voting an investment control with respect to
these shares.
|
27
|
|
|
(19)
|
|
Kenneth Pasternak, the Managing Member of the General Partner of Chestnut Ridge
Partners, LP, has sole voting and investment control with respect to these shares.
|
|
(20)
|
|
Thomas Brazil, President and beneficial owner, has sole investment power with
respect to these shares. Includes 386,600 shares of common stock and warrants to purchase an
aggregate of 115,701 shares of common stock previously issued and outstanding.
|
|
(21)
|
|
Mr. Benjamin Levi, attorney and beneficial owner, has sole voting and investment
power with respect to these shares. Includes an aggregate of 494,480 shares previously issued
and outstanding.
|
|
(22)
|
|
Thomas Madden, President and Owner, has sole voting and investment power with
respect to these shares.
|
|
(23)
|
|
Jamie Lissette, President and Owner, has sole voting and investment power with
respect to these shares.
|
|
(24)
|
|
Cory P. Schlossmann, managing member, and Joseph Kowal, Member, have voting and
investment power with respect to these shares.
|
|
(25)
|
|
Jeffrey Wolin, Owner, has sole voting and investment power with respect to these
shares.
|
|
(26)
|
|
Marie-Christine Wright, Director and beneficial owner, has sole voting and
investment power with respect to these shares. Includes previously issued and outstanding
warrants to purchase 227,586 shares of common stock.
|
|
(27)
|
|
Reid Drescher, President and CEO, has sole voting and investment power with respect
to these shares.
|
In our most recent private offering, two of the selling shareholders listed above, Galileo
Asset Management, S. A. (and their designees) and Spencer Clarke, LLC (and their designees), acted
as our placement agents for the private placement in November 2007, for which they or their
assignees received, in addition to cash compensation equal to 10% of the purchase price of our
securities sold by them, collectively warrants to purchase an aggregate of 200,751 shares of our
common stock. They will also receive a cash commission of 6% percent upon exercise of the warrants
issued to the purchasers in that private placement. Galileo Asset Management, S.A. and Spencer
Clarke, LLC also received a non-accountable expense allowance of $75,000 each in the offering.
Galileo Asset Management, S.A. has also acted as a placement agent in a number of prior offerings
of our securities. Except as otherwise indicated above or in the footnotes to the table, the
selling stockholders have not held any position or office or had any material relationship with us
or any of our subsidiaries within the past three years and the selling stockholders possess sole
voting and investment power with respect to the shares shown.
The selling stockholders will sell their shares in one or more market transactions on the
American Stock Exchange or in privately negotiated transactions at standard terms, including
commissions at market rates for similar transactions.
PLAN OF DISTRIBUTION
Shares of common stock covered hereby may be offered and sold from time to time by the selling
stockholders. Each selling stockholder will act independently of us in making decisions with
respect to the timing, manner and size of each sale. Each selling stockholder may sell the shares
being offered hereby (i) on the American Stock Exchange, or otherwise at prices and at terms then
prevailing or at prices related to the then current market price or (ii) in private sales at
negotiated prices or by a combination of such methods of sale.
Any broker-dealer participating in such transactions as agent may receive commissions from
each selling stockholder (and, if acting as agent for the purchaser of such shares, from such
purchaser). Usual and customary brokerage fees will be paid by each selling stockholder.
Broker-dealers may agree with each selling stockholder to sell a specified number of shares at a
stipulated price per share, and, to the extent such a broker-dealer is unable to do so acting as
agent for each selling stockholder, to purchase as principal any unsold shares at the price
required to fulfill the broker-dealer commitment to each selling
28
stockholder. Broker-dealers who acquire shares as principal may thereafter resell such shares
from time to time in transactions (which may involve crosses and block transactions and which may
involve sales to and through other broker-dealers, including transactions of the nature described
above) on the American Stock Exchange, in negotiated transactions or by a combination of such
methods of sale or otherwise at market prices prevailing at the time of sale or at negotiated
prices, and in connection with such resales may pay to or receive from the purchasers of such
shares commissions computed as described above.
Each selling stockholder and any underwriter, dealer or agent who participates in the
distribution of such shares may be deemed to be underwriters under the Securities Act of 1933,
and any discount, commission or concession received by such persons might be deemed to be an
underwriting discount or commission. Each selling stockholder may indemnify any broker-dealer who
participates in transactions involving the sale of the shares against certain liabilities,
including liabilities arising under the Securities Act of 1933.
LEGAL MATTERS
The validity of the shares of common stock offered hereby will be passed upon by Bryan Cave
LLP, Irvine, California.
EXPERTS
The consolidated financial statements as of December 31, 2006 and for each of the two years in
the period ended December 31, 2006 incorporated in this prospectus by reference from AMDL, Inc.s
(the Company) Annual Report on Form 10-KSB for the year ended December 31, 2006 have been audited
by KMJ Corbin & Company LLP, an independent registered public accounting firm, as stated in their
report (which report expresses an unqualified opinion and includes explanatory paragraphs relating
to the Companys adoption of Statement of Financial Accounting Standards No. 123(R), Share-Based
Payment, and the substantial doubt about the Companys ability to continue as a going concern),
which is incorporated herein by reference, and has been so incorporated in reliance upon the report
of such firm given upon their authority as experts in accounting and auditing.
AVAILABLE INFORMATION
We file annual, quarterly, and current reports, proxy statements, and other documents with the
SEC. You may read and copy any document we file at the SECs public reference room at: 100 F
Street N.E., Room 1580, Washington, DC 20549. You should call (202) 551-8090 for more information
on the public reference room. The SEC maintains an internet site at
http://www.sec.gov
where
certain reports, proxy and information statements, and other information regarding issuers
(including AMDL) may be found. In addition, such material concerning us may be inspected at the
offices of the American Stock Exchange, 86 Trinity Place, New York, New York 10006.
This prospectus is part of a registration statement filed with the SEC. The registration
statement contains more information than this prospectus regarding us and our common stock,
including certain exhibits filed. You can get a copy of the registration statement from the SEC at
the address listed above or from the SECs internet site.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to incorporate into this prospectus information we file with it in other
documents. This means that we can disclose important information to you by referring to other
documents that contain that information. The information incorporated by reference is considered
to be part of this prospectus, and information we file later with the SEC will automatically update
and supersede this information. We incorporate by reference the documents listed below, except to
the extent information in those documents is different from the information contained in this prospectus,
and all
29
future documents filed with the SEC under Sections 13(a), 13(c), 14, or 15(d) of the
Securities Exchange Act of 1934 until we terminate the offering of these shares (File No. 1-16695):
|
|
|
Registrants Annual Report on Form 10-KSB for the year ended December 31, 2006, as
amended by Amendment No. 1 to our Annual Report on Form 10-KSB filed June 21, 2007;
|
|
|
|
|
Registrants Quarterly Reports on Form 10-QSB for the periods ended March 31, 2007
and June 30, 2007, as well as the Form 10-QSB for the period ended September 30, 2007,
which was amended on February 22, 2008;
|
|
|
|
|
Registrants Current Reports on Form 8-K filed October 5, 2007 and October 15, 2007;
Registrants Current Report on Form 8-K/A filed December 10, 2007; and Portions of
Registrants Current Reports on Form 8-K filed May 7, 2007, June 7, 2007 and December
26, 2007; and
|
|
|
|
|
The description of the Registrants common stock contained in its Registration
Statement on Form 8-A filed September 21, 2001.
|
We will provide without charge to each person, including any beneficial owner of common stock,
to whom this prospectus is delivered, upon the written or oral request of such person, a copy of
any and all of the documents that have been incorporated by reference in this prospectus (not
including exhibits to such documents unless such exhibits are specifically incorporated by
reference therein). Requests should be directed to: AMDL, Inc., 2492 Walnut Avenue, Suite 100,
Tustin, California 92780-7039, Attention: Gary L. Dreher, Chief Executive Officer, Telephone (714)
505-4460.
30
PART II
INFORMATION NOT REQUIRED
IN PROSPECTUS
Item 14. Itemized Statement of Expenses.
The table below sets forth the estimated expenses (except the SEC registration fee, which is
an actual expense) in connection with the offer and sale of the shares of common stock of the
registrant covered by this Registration Statement.
|
|
|
|
|
SEC Registration Fee
|
|
$
|
543
|
|
Legal Fees and Expenses
|
|
|
15,000
|
|
Accounting Fees and Expenses
|
|
|
10,000
|
|
Printing Fees and Expenses
|
|
|
2,000
|
|
Miscellaneous
|
|
|
457
|
|
|
|
|
|
Total
|
|
$
|
28,000
|
|
Item 15. Indemnification of Directors and Officers.
Delaware law and AMDLs Certificate of Incorporation and Bylaws provide that AMDL shall, under
certain circumstances and subject to certain limitations, indemnify any director, officer, employee
or agent of the corporation made or threatened to be made a party to a proceeding, by reason of the
former or present official capacity of the person, against judgments, fines, settlements and
reasonable expenses incurred by the person in connection with the proceeding if certain statutory
standards are met. Any such person is also entitled, subject to certain limitations, to payment or
reimbursement of reasonable expenses in advance of the final disposition of the proceeding.
Proceeding means a threatened, pending or completed civil, criminal, administrative, arbitration
or investigative proceeding, including one by or in the right of the corporation.
AMDLs directors, officers, agents and employees are entitled to indemnification by each of
the selling stockholders against any losses arising out of or based upon any untrue statement or
alleged untrue statement or omission or alleged omission made in this registration statement and
the prospectus contained herein made in reliance upon written information furnished to AMDL by such
selling stockholder for use in this registration statement or the prospectus.
AMDL has also entered into indemnification agreements with its directors whereby AMDL has
agreed to indemnify and hold them harmless from and against any claims, liability, damages or
expenses incurred by them in or arising out of their status, capacities and activities with respect
to AMDL to the maximum extent permitted by Delaware law. AMDL believes that these agreements are
necessary to attract and retain qualified persons as directors and executive officers.
AMDL also maintains a directors and officers insurance policy with aggregate limits of
$2,000,000 pursuant to which our directors and officers are insured against liability for certain
actions in their capacity as directors and officers.
Item 16. Exhibits.
The exhibits to this Registration Statement are listed in the Index to Exhibits included
elsewhere in this Registration Statement.
Item 17. Undertakings.
(a) The undersigned registrant hereby undertakes:
II-1
|
(1)
|
|
To file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
|
|
(i)
|
|
To include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933;
|
|
|
(ii)
|
|
To reflect in the prospectus any facts or events arising after
the effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the aggregate,
represent a fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease in volume of
securities offered (if the total dollar value of securities offered would not
exceed that which was registered) and any deviation from the low or high end of
the estimated maximum offering range may be reflected in the form of prospectus
filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the
changes in volume and price represent no more than a 20% change in the maximum
aggregate offering price set forth in the Calculation of Registration Fee
table in the effective registration statement;
|
|
|
(iii)
|
|
To include any material information with respect to the plan of
distribution not previously disclosed in the registration statement or any
material change to such information in the registration statement;
|
provided, however
, that paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) above do
not apply if the registration statements is on Form S-3 and the information required to be
included in a post-effective amendment by those paragraphs is contained in reports filed
with or furnished to the Commission by the Registrant pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934 that are incorporated by reference in the registration
statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is
part of the registration statement.
|
(2)
|
|
That, for the purpose of determining any liability under the Securities Act of
1933, each such post-effective amendment shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof.
|
|
|
(3)
|
|
To remove from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination of the offering.
|
(b) The undersigned registrant hereby undertakes that, for the purposes of determining any
liability under the Securities Act of 1933, each filing of the registrants annual report pursuant
to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable,
each filing of an employee benefit plans annual report pursuant to Section 15(d) of the Securities
Exchange Act of 1934) that is incorporated by reference in the registration statement shall be
deemed to be a new registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial bona fide offering
thereof.
(c) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers and controlling persons of the registrant pursuant to the
provisions described under Item 15 above, or otherwise, the registrant has been advised that in the
opinion of the Securities and Exchange Commission such indemnification is against public policy as
expressed in the Securities Act of 1933 and is, therefore, unenforceable. In the event that a
claim for indemnification against such liabilities (other than the payment by the registrant of
expenses incurred or paid by a director, officer or controlling person of the Registrant in the
successful defense of any action, suit or proceeding) is asserted by such director, officer or
controlling person in connection with the securities being registered, the registrant will, unless
in the opinion of its counsel the matter has been settled by controlling precedent, submit to a
court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed
in the Securities Act of 1933 and will be governed by the final adjudication of such issue.
II-2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1933, the Registrant certifies
that it has reasonable grounds to believe that it meets all of the requirements for filing on Form
S-3 and has duly caused this registration statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Tustin, State of California on February 27, 2008.
|
|
|
|
|
|
AMDL, INC.
|
|
|
By:
|
/s/ Gary L. Dreher
|
|
|
|
Gary L. Dreher, President
|
|
|
|
|
|
|
POWER OF ATTORNEY
Each director whose signature appears below constitutes and appoints Gary L. Dreher, his true
and lawful attorney-in-fact and agent, with full powers of substitution and re-substitution, for
him and in his name, place and stead, in any all capacities, to sign any or all amendments
(including post-effective amendments) to this registration statement, and to file the same, with
all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange
Commission, granting onto said attorney-in-fact and agent, full power and authority to do and
perform each and every act and thing requisite or necessary to be done in and about the premises,
as fully to all intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorney-in-fact and agent, or his substitute or substitutes, may lawfully
do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Act of 1933, this registration statement has
been signed by the following persons in the capacities on February 27, 2008.
|
|
|
Signature
|
|
Title
|
|
|
|
/s/ Gary L. Dreher
GARY L. DREHER
|
|
President, Chief Executive Officer and
Director (Principal Executive Officer)
|
|
|
|
/s/ Akio Ariura
AKIO ARIURA
|
|
Chief Financial Officer (Principal Financial
Officer and Principal Accounting Officer)
|
|
|
|
/s/ Douglas C. MacLellan
DOUGLAS C. MACLELLAN
|
|
Director
|
|
|
|
/s/ Edward R. Arquilla
EDWARD R. ARQUILLA
|
|
Director
|
|
|
|
/s/ Minghui Jia
MINGHUI JIA
|
|
Director
|
|
|
|
/s/ William M. Thompson, III
WILLIAM M. THOMPSON III
|
|
Director
|
II-3
INDEX TO EXHIBITS
|
|
|
Exhibit
|
|
|
|
|
|
5.1
|
|
*Opinion and Consent of Bryan Cave LLP
|
|
|
|
23.1
|
|
*Consent of Bryan Cave LLP (included within Exhibit 5.1)
|
|
|
|
23.2
|
|
*Consent of KMJ Corbin & Company LLP
|
|
|
|
24.1
|
|
Power of Attorney (included on the signature page of this Registration Statement)
|
II-4
Amdl (AMEX:ADL)
Historical Stock Chart
From May 2024 to Jun 2024
Amdl (AMEX:ADL)
Historical Stock Chart
From Jun 2023 to Jun 2024