AMDL Interim Report 12-15-08

AMDL December 15, 2008

 

Third Quarter Report on AMDL


Symbol: ADL    American Stock Exchange

Share Price - $0.80


  December 15, 2008 

Risk Level: High    12 Month Target: $5.00     Recommendation:
Buy


Data as of December 15, 2008


0.78/20

Bid/Size

 

0.80/65

Ask/Size

 

0.80

Price Open

0.80

Close

 

0.87

Day High

 

0.70

Day Low

2.49

Beta

 

4.35  12/26/07

52wk High/Date

 

0.60  11/19/08

52wk Low/Date

12.7 Million

Market Capitalization

 

15.9 Million

Shares Outstanding

 

141.40

Volatility Avg(20 day)

32.5 Thousand

Avg Vol (10 day)

 

NM

P/E Ratio

 

-0.3842

EPS (TTM)

 

 

SUMMARY

 

Since our last report on AMDL we have lowered our projected share price, however this should not be thought of as a decline in our positive attitude towards the Company, its management or long-term upside potential. In fact, exactly the opposite is true.

 

Current market conditions aside, Wall Street’s lack of reaction to the major initiatives AMDL has taken to build its strengths while reorganizing top management and still producing respectable financials has resulted in AMDL being one of the most under priced stocks we have seen in a long time. While we recognize liquidity still remains somewhat of a problem, AMDL’s management has -- and is -- currently taking the appropriate steps to increase its working capital so the markets no longer view the Company as being in danger of depleting its operational funds. It is for this reason we continue to maintain a bullish view on the Company. (Please see the Opinion section at the end of this report.) 

 

COMPANY OVERVIEW

 

Headquartered in Tustin, California, AMDL is a vertically integrated pharmaceutical company with three distinct business divisions that include: (i) in-vitro (“IV”) diagnostics, (ii) cancer therapeutics and (iii) China-based integrated pharmaceuticals. Collectively, these business units focus on the development, manufacturing, distribution and sales of high quality generic pharmaceuticals, nutritional supplements, cosmetic and medical diagnostic products in the U.S., the People’s Republic of China (“China” or “PRC”) through our subsidiary Jade Pharmaceutical Inc. (“JPI”), Korea, Taiwan and other markets throughout the world.

 

Through its subsidiary Jade Pharmaceuticals Inc. (JPI), the Company manufactures and distributes 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 (“Kangda”).

 

YYB’s facilities are located in Tuman City, Jilin Province, China and JJB is located in Shangrao, Jiangxi Province, China. JPI currently manufactures and markets 49 products. Of these products, 24 are branded generic western drug formulations and 25 are branded Chinese traditional medicine, beauty and nutritional products. Additionally, in the third quarter of 2008 JPI launched a line of facial creams based on the Company’s best-selling Goodnak product line which is an injectable anti-aging pharmaceutical product used primarily for cosmetic purposes. JPI is also licensing other pharmaceutical products which will require the manufacturing approval of the PRC’s State Federal Drug Agency (“SFDA”). 

 

AMDL also sells OEM products and test kits which are manufactured by others. The Company’s products may be used by hospital, clinical, research and forensic laboratories and doctor’s offices to obtain precise and rapid identification of certain types of cancer and other diseases. The Company’s proprietary DR-70® test kit may be used to assist in the detection of at least 13 different types of cancer, including: lung (small and non-small cell), stomach, breast, rectal, colon, and liver.

 

However, in nine of the thirteen cancer types there were not sufficient patient numbers in the clinical trials to equivocally determine the effectiveness at the detection of cancer. As DR-70® is a non-invasive blood test; there are no side effects to the administration of the 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 available for sale in the U.S., however, limitations on the availability of certain components used in the test kit have led management to conclude that it will need to seek USFDA approval of a reformulated test kit.

 

RECENT EVENTS

 

Change in Upper Management

 

Effective October 31, 2008, the Company’s Chief Executive Officer, President and a member of the Board of Directors, Gary L. Dreher retired and Douglas MacLellan assumed the role of Chief Executive Officer and Executive Chairman. Mr. Michael Boswell was appointed as an independent member of the board as Chairman of the Audit and Compensation committees.  Long-standing board member Dr. William Thompson assumed the role of Chairman of the Governance Committee.

 

MacLellan transitioned into his new role after nearly 16 years on AMDL’s Board of Directors.  He was appointed in 1992 and became Chairman of the Audit and Governance committees in 2001. Earlier this year he assumed the role of non-executive Chairman serving as an advisor and lead Company spokesperson for AMDL.  He brings extensive international business experience to his role.  Mr. MacLellan also brings significant experience in China-based business operations and management where he has been actively involved since 1983.  Mr. MacLellan is a recognized authority on Chinese joint venture and wholly foreign owned enterprise (WFOE) structuring and considered an expert on the China government and regulatory and compliance system. 

 

Among his other accomplishments, Mr. MacLellan also brings over twenty years of active board experience to AMDL. He has been a catalyst for the development and financing of global businesses in the United States and internationally. He has served on the board of 18 private and publicly-held companies playing an instrumental role in the strategic planning, general operations, corporate finance, economic policy, asset allocation and mergers & acquisition activities. Furthermore, Mr. MacLellan has helped raise more than US$715 million in capital for many of these organizations.

 

While MacLellan not only has the necessary credentials, it became readily apparent that AMDL was desirous of a more open relationship with the financial media and Wall Street. Since MacLellan took over, we have noticed a considerably greater transparency with regard to both financial and product sales projections. We feel that this step was long past due. This step was long past due.

 

Boswell is co-founder of the TriPoint family of companies and co-founder and member in TriPoint Capital Advisors, LLC -- a boutique merchant bank focused on small and mid-sized growth companies. He has been active in the Chinese market since 2000 providing high-level financial guidance and services to start-up, small and mid-sized companies.

 

Akio Ariura – AMDL’s company’s Chief Financial Officer, was promoted and assumed the additional title of Chief Operating Officer.  As COO and CFO, Ariura is leading the day-to-day operations of AMDL, including direct responsibility for AMDL’s legal, financial, and business affairs, employee development and recruiting,  and high-priority companywide initiatives, including the implementation of its Kingdee ERP accounting system within the US and China.

 

AMDL also expanded its senior management team with the appointment of Mr. Christopher Gee as Director of International Marketing and Sales and Mr. Raymond Gatchalian as Director of Compliance and Information Technology.

 

Gee is a former Apple Inc. executive and tech/biotech industry veteran with extensive business operations, international sales and marketing management experience. While at Apple, Gee successfully managed business development and enterprise computing projects. Gatchalian has an extensive background in IT audit and compliance, working for both large and small companies.  His primary responsibility included planning, conducting and managing system audits and providing consulting services to various IT organizations.

 

DR-70®

 

At the beginning of July, the FDA granted AMDL clearance to market DR-70® as a safe and effective blood test for monitoring patients who have been previously diagnosed with colorectal cancer (CRC). With the approval by the FDA, AMDL is now actively seeking distribution channels.  At the same time the company is pursuing additional clinical trials and working to improve the DR-70® product. While efforts in those directions will likely take six months to a year to come to fruition and could possibly delay an encompassing DR-70® distribution agreement, we feel that management’s obvious decision to proceed cautiously will be justified by the subsequent results.

 

Although the Company has obtained approval from the USFDA to market the then current formulation of DR-70® it has been determined that one of the key components of the DR-70® -- the anti-fibrinogen-HRP is limited in supply and additional quantities cannot be purchased. There are currently enough DR-70® test components to perform approximately 1.2 million individual tests (31,000 test kits) over the next 12-18 months.  Based on current and anticipated orders, this supply is adequate to fill all orders. The Company is currently testing substitute antibodies and will perform additional quality assurance testing in order to validate a significant supply of the current version of the DR-70® test kit.

 

Part of the Company’s research and development efforts through 2010 will include the testing and and validation of an improved version of the DR-70® test kit. The new version will be run on an automated analyzer instead of the manual testing procedure used in the current version. Pilot studies show that the new version will likely be superior to the current version in its performance; i.e., fewer false positives and fewer false negatives. The Company has signed agreements with a reputable third party to take the lead on necessary clinical studies. It is anticipated that this version will be submitted to the USFDA in the latter half of 2010.

 

The depth of the marketplace for DR-70® is evident from the work done by Kalorama Research indicating that the world market for in vitro diagnostic tests for cancer is growing at nearly 11% annually and could reach nearly $8 billion by the end of 2012. FDA clearance to market was based upon data showing DR-70® has the ability to monitor the progression of colorectal cancer post-surgery in patients who are biopsy confirmed with this disease. Post-surgery testing with DR-70® enables cancer patients to determine if their treatment is effective and whether or not their colorectal cancer is out of remission.

 

CRC is the third most common cancer worldwide and the second leading cause of cancer deaths (irrespective of gender) in the United States according to the National Cancer Institute. It is estimated there will be approximately 150,000 new cases diagnosed in the US in 2008, roughly 51,000 deaths due to the disease, and almost half of all patients thought to be "cured" will develop a recurrence of CRC within 5 years — usually due to undetected metastases.

 

The approval of DR-70® marks the first clearance to market the FDA has granted for any monitoring product for CRC since January 14, 1982 when Carcinoembryonic Antigen, or what is commonly known as the CEA test, was approved. Until now, the CEA test has been the only accepted method approved in the U.S. DR-70®offers a new test that can monitor CRC tumors post-surgery.

 

In order to comply with the new SFDA guidelines in China, in September of 2008, the Company retained Jyton & Emergo Medical Technology, a China based company to:

  • Compile technical file and prepare clinical protocol;
  • Clinical trial preparation and design;
  • Clinical trial supervision and monitoring;
  • Apply for SFDA approval

Additionally, now that the USFDA has granted clearance, it is likely that JPI will seek to obtain approval for DR-70® as expediently as possible. 

 

Human Papilloma Virus (HPV)

 

On April 3, 2008 AMDL announced that it has entered into an exclusive sublicense agreement with MyGene International for the MyGene MYHPV Chip® Kit, a diagnostic product designed to screen for cervical cancer in women by providing in-vitro genotype information for the Human Papilloma Virus (HPV), which is linked with cervical cancer in greater than 95% of patients with confirmed cervical cancer. The agreement between MGI and AMDL is an exclusive sublicense to use the patents, trademark, and technology in manufacturing, promoting, marketing, distributing, and selling the MYHPV Chip® Kit in the countries of China (including Hong Kong), Taiwan, Singapore, Malaysia, Thailand, Cambodia, and Vietnam. MGI owns an exclusive worldwide license (excluding Korea) for the MYHPV Chip® Kit.

 

During its most recent due diligence, the company discovered potential issues involving the patents which are an integral part of the license agreements. Although the company is trying to remediate the problems with MGI, it is not known how long this process will take. Since AMDL has remitted an additional $10,000 refundable payment as a show of good faith that it is committed to moving forward with the license agreement, we are going to cover the product briefly since it is potentially a valuable asset. However, we are not incorporating any potential revenues and earnings for this product line until the problems are resolved and anyone looking at the company should make note of the problem in deciding on the advocacy of investing in the stock.

 

HPV is the most common sexually transmitted infection. Globally there are approximately 330 million women presently infected with HPV, with 70% of existing infections in Asian populations. The virus infects the skin and mucous membranes. There are more than 30 important HPV types that can infect the genital areas of men and women.

 

Most people who become infected with certain types of HPV do not even know they have it. Cervical cancer is third leading cancer in women and the second leading cause of cancer deaths in women worldwide. It is well known that certain HPV types are the primary cause of cervical cancer. If HPV infection is detected early, cervical cancer could be prevented. Early diagnosis of HPV infection, which could lead to cervical cancer, is recommended for every woman.

 

According to recent clinical trial assessments in Medical News Today (medicalnewstoday.com), the global market for HPV testing is projected to be $250 million in 2008 with the total available market valued at $1 billion.

 

Studies are underway evaluating the use of HPV tests as a primary screen for cervical cancer in women, supplementing the standard PAP testing. Preventive Oncology International notes that worldwide cervical cancer remains the second most common malignancy in both incidence and mortality, it is the greatest cause of death from cancer in women in the developing world yet HPV screening is lowest there (see Figure 1). Forty percent of the world’s cervical cancer occurs in India and China alone. In developing countries, most of the limited medical funding is spent on disease treatment instead of prevention.

 

 

 

 

Fortunately, the GAVI Alliance (formerly known as the Global Alliance for Vaccines and Immunization) — a partnership of national governments, the World Health Organization, the World Bank, the Bill and Melinda Gates Foundation, the vaccine industry, public health institutions, and nongovernmental organizations — provides technical assistance and financial support for screening and vaccines in countries with a gross national income of less than $1,000 per capita, as well as in China, India, and Indonesia.

 

This pro-active funding is an important way to get in front of the growing crisis. In PRC China alone, at an extremely conservative estimate of 1,000,000 (there are approximately 455,960,489 women between 15 and 64 years old, 2007 CIA Factbook) with HPV screening at a cost of approximately $50 (price quoted in Forbes Magazine, 1/28/08) there is a $50,000,000 million USD annual market potential for a product that actually saves lives, saves human suffering, and saves precious medical financial resources. MyGene International, an international biotech company, estimates HPV testing in PRC China to grow from approximately 16 million tests in 2009 to over 25 million by 2025.

 

Recent advances in vaccines are also proving valuable in the struggle to prevent HPV and possibility of cervical cancer. 2006 saw the launch of Gardasil from Merck and Co., the first vaccine protecting against HPV (human papilloma virus) and the development of cervical cancer. Another HPV vaccine, Cervarix, from Glaxo-Smith Kline, was launched in 2007.

 

According to Visiongain report “World Market for Cancer Vaccines 2007-2012” these two vaccines are  predicted to generate sales of more than $4 billion by 2012, which could see them becoming top selling vaccines on a global level.

Because of the infection rate, many public health experts recommend mandatory HPV vaccination and screenings (George Washington University Report, 12/07). Condoms do not provide comprehensive protection against HPV. Both men and women are carriers of HPV. It is reasonable that those at risk in both sexes should get regular screenings and/or vaccines.

 

HPV Screening Tests: Extremely Important Tool As a primary tool, HPV screening has evolved beyond the Pap smear test (developed in 1941) into a more efficient and precise scientific endeavor in the last decade. As stated in a recent Forbes Magazine health report (“The Cancer That Shouldn't Be” 1/28/08), it borders on the scandalous that cervical cancer, among the few cancers that are preventable, kills 310,000 women a year worldwide.

 

In 2007, 11,150 women in the U.S. were diagnosed with it. Half of them had not had a recent Pap test. Another third did get tested but got false negatives from the 65-year-old Papanicolaou (Pap test) biopsy. The Pap test is valuable; having cut the rate of cervical cancer by 70%, but it is archaic. It calls on a lab technician or machine to peer at a daub of cervical cells under a microscope to spot the abnormal precancerous ones. This approach yields false negatives between 13% and 45% of the time.”

 

Furthermore in China, Qiao Youlin, Director for the Department of Cancer Epidemiology at the Chinese Academy of Medical Sciences in Beijing, said, “In developing countries, most of the limited medical funding is spent on disease treatment instead of prevention.  As a result, developing countries account for 80 per cent of the total number of the world's cases of cervical cancer.”

 

Pap smear test results in developing countries are often unreliable, with poor techniques of obtaining the samples and analyzing them. Unlike Pap smears with lab intensive microscopic evaluations and lab analysis, new biotech companies are developing more efficient and precise HPV testing kits. At the forefront of HPV detection test kits are companies such as MyGene, German diagnostic tools firm Qiagen, and Digene Biotech of Gaithersburg, Maryland (recently acquired by Qiagen).

 

MYHPV Chip® Kit (see Figure 2) was approved as a diagnostic reagent for in-vitro testing for HPV by the KFDA (Korean Food and Drug Administration). The test can diagnose cervical cancer through its direct relationship to HPV infection and provide for specific genotype information at the same time. Genotype information tells the doctor whether the patient is likely to develop cancer or not because some HPV strains are known to be more virulent than others. Features of the MyHPV Chip® Kit include: 

    ·         Pre-Diagnosis of cervical cancer

    ·         Diagnosis of HPV Infection and Genotype Information for the HPV Infection

    ·         Detection of low copy number HPV Infections

    ·         Diagnosis of Multiple HPV Infection

    ·         Sample Collection during PAP test

    ·         Accurate and prompt Results

    ·         Identifying total 24 (19 in the Korean FDA approved version) types of HPV Infections (16 high-risk, 8 low-risk)

 

 

  Figure 2

 

 

Medical News Today reported that the global market for HPV testing is projected to be $250 million in 2008, with the total available market valued at $1 billion. There are more than 10 million HPV tests being performed annually in the United States alone, with only 28% market penetration.

 

The 2007 CIA Factbook indicated that in China there are approximately 455 million women between the ages of 15 and 64 years old. In China alone, at an extremely conservative estimate of 1 million possible patients, with HPV screening at a cost of approximately $50, there is a $50 million annual market potential for HPV testing in China. Estimates indicate that HPV testing in China could grow from approximately 16 million tests in 2009 to over 25 million by 2025.

 

OVERVIEW OF JPI’s BUSINESS

 

JPI is currently the major engine for AMDL in terms of both revenue and profit. JPI manufactures generic, homeopathic over-the-counter pharmaceutical products and supplements. Beginning in the third quarter of 2008, JPI launched a line of facial creams based on its Goodnak product -- the injectible anti-aging pharmaceutical product used primarily for cosmetic purposes.  JPI manufactures and distributes its products through two wholly-owned Chinese subsidiaries, Yangbian Yiqiao Bio-Chemical Pharmacy Company Limited (“YYB”) and Jiangxi Jiezhong Bi-Chemical Pharmacy Company Limited (“JJB”).

 

JPI and YYB currently manufacture and market 49 diagnostic, pharmaceutical, nutritional supplement and cosmetic products. JPI is also researching and developing other pharmaceutical products which will require the approval of the SFDA. The top selling products in China are Goodnak (anti-aging cosmecutical), Domperidone (anti-emetic, Levofloxacin Lactate and Sodium Chloride Injections (antibiotic) and Glucose solutions (pharmaceutical).

 

JJB employs regional sales managers and over three hundred representatives who contact hospitals and distributors throughout China. Distributors have the right to return product only if the product is defective.

 

YYB has established a multi-level marketing program of approximately forty sales managers and engages over 1,000 sales representatives who act as individual marketers of YYB’s products. YYB’s products are primarily sold directly to three institutional or hospital customers.

 

Both JJB and YYB are developing educational programs for hospitals, doctors, clinics and distributors with respect to JJB’s and YYB’s product lines. These educational programs are intended to improve sales and promotion of JJB’s and YYB’s 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 PRC. In addition, JJB and YYB have a dedicated sales team that manages its own direct sales force and retail outlets all over China.

 

JPI currently has 75 in house full-time sales people and is expected to increase this number over the next twelve months to market JPI’s new products.

 

As JJB’s and YYB’s 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 by existing distributors or the in-house sales force.

 

JJB’s 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.

 

JJB has held recent discussions with the Chinese military located in Shangrao County, Jiangxi Province. Based upon these discussions the following initial understanding has been developed on the potential acquisition of JJB’s injection production lines. It should be noted that JJB has two separate Shangrao County based manufacturing facilities that each have two separate production lines. Only one of these JJB production facilities are located adjacent to a Chinese military base and is subject to acquisition by the Chinese military.

 

Under this initial understanding, the Chinese Military will allow at least 2 years for JJB to build new production lines at a new location or acquire another pharmaceutical company, with similar injection production capabilities. This will allow JJB to smoothly transition its production capabilities to an alternative site. JJB will not move its current injectable production from its current location until the new production capabilities are online and have passed all necessary the CGMP approvals.

 

Currently JJB is asking the Chinese military for RMB 30 million (approximately US$4.41 million) in compensation for having to move the two JJB production lines and is also asking for this payment to be made in installments associated with any new plant-building milestones. 

 

The Chinese military is coordinating with Shangrao county and city local governments in order to find an appropriate industrial location and or existing pharmaceutical plant where JJB could move its injectable production lines to. Thus far, the city and county governments have yet to locate any suitable industrial locations and or pharmaceutical plants in the Shangrao Economic Development Region that meet JJB's requirements. The city and county officials intend to continue this search process. Its understood by all parties that this site location process may take some time and thus the acquisition process could be delayed. Alternative sites in other cities are also being considered, wherein JJB could consolidate all four of its production facilities into one new plant location paid for in part by the military.

 

JJB’s 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 modifications required by the SFDA are now complete and operations slated to resume in the first quarter of 2009.

 

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.

 

 JJB’s primary products in the large volume injectable category are:

 

    Human Placental Tissue Extract Lotion

 

    Domperidone Tablet

 

    50% NACL G.S.

 

    Compound Benzoic Acid and Camphor Solution

 

    Levofloxacin Hydrochloride Injection

 

Product Commercialization Pipeline

 

The following products are expected to become commercially viable in:

 

Mid-2009

 

·         Creatine Phosphate Sodium Injections (Heart Medication)

·         Renergie Microlift

·         Fresh Cell

·         Vitamin C Oil

·         Detoxigenol

·         Wrinkle Removing Repair Cream

·         HydraMax Moisturizer Cream

·         HydraMax Whitening Cream

·         Pure Detoxigenol Cream

 

Late 2009

 

·         Docetaxel (Cancer Treatment)

·         Epinastine Tablets (Allergy Pharmaceutical)

·         Pidotiod Tablets (Anti-aging products)

·         TouJin Niangshi (Herbal liver cancer treatment)

 

2010

 

·         Drotaverrine Hydrochloric (Anti-emetic)

·         Diammonium Glycyrrhizinate (Anti-emertic)

 

2011

 

·         MyHPV Chip Kit®

 

2012 

 

·         Combination Immunogene Therapy (CIT) Cancer Vaccine

 

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 JJB’s 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.  It shares the same markets in China as American Oriental Bioengineering, Tiens Biotech Group and China Medical Technologies, along with a number of other companies.

 

FINANCIALS

 

Summary

 

For the three months ended September 30, 2008, total net revenues from product sales increased 59.5% to $9,202,638 from $5,769,292 for the same period in 2007, while net revenues from the amortization of up-front fees was $43,777 as compared to $39,084 for the same period in 2007. A the same time, gross profit for the period increased 35.6% to $4,855,842, as compared to $3,581,684 for the same period in 2007.

 

Looking at a full nine months ended September 30, 2008, net revenues from product sales increased 93.0% to $18,614,993 from $9,646,056 for the same period in 2007, while revenues from the amortization of up-front fees was $128,629 as compared to $39,084 for the same period in 2007. Gross profit for the nine months ended September 30, 2008 increased 74.6% to $9,530,676, compared to $5,460,005 for the same period in 2007.

 

We are happy to see that AMDL continues to provide guidance going forward, most recently for 2009. According to the company’s latest statement, gross revenues for 2009 are expected to range between $60 and $76 million with net income between $11.6 and $14.6 million before foreign currency translation.

 

With around 16.9 million shares outstanding that means earnings per share should range $0.68 to $0.86 per share. At a recent stock price of $0.80 that is a projected 2009 P/E range (ignoring currency translations) of 1.3 to 1.0. ADL is trading about 34% of 2008 projected sales and only 20% of 2009 sales guidance where similar stocks typically trade at 2 times sales or better.

The company’s performance in the coming year will come from:

 

·       The planned geographic expansion from the current 36 to 100% of China's 168 cities with over one million people. That will mean new marketing and distribution acquisitions

·       Potential acquisition of marketing & distribution entities

·       Expanding marketing efforts of Dr-70® for the US and other Asian countries

·       Expand into international markets with Goodnak anti-aging products

 

Therefore, we see AMDL's growth taking place as a result of: 

  • R&D and product development for products with higher gross-profit- margins
  • Developing strategic partnerships with manufacturers and distributors to promote synergistic product distribution and sales
  • Commercializing key products including AMDL's DR-70® ELISA in vitro diagnostic cancer test and new product formulations for its best-selling Goodnak® anti-aging product line
  • Refined sales, marketing and branding strategies to promote the sales of products with higher gross-profit-margins while increasing the associated market share
  • Increasing its core sales and distribution teams which will focus on selling in major cities in China supporting 1 million or more citizens, and selling select products in other international markets
  • Leveraging US and China-based production plants to ensure necessary quantities of both new and existing products are available to meet customer demand

The company has reaffirmed its plans to double sales annually over the next three years, thereby establishing JPI as one of the top 10 pharmaceutical companies in China. See Figure 4.

 

We have not included any sort of potential future acquisitions or sales coming from the company’s Combination Immunogene Therapy technology and management said it will continue to evaluate the business outlook for that product line. We feel that this is a product that will one day be sold since it does not appear to fit with the company’s core business line.

 

Probably the greatest concern is not the Company’s ability to increase revenue and earnings but its need to meet its rising cash requirements until such time as the company generates sufficient earnings to meet those needs. To that end, the company announced on Dec. 9 that it had closed on the first tranche of a private placement offering of 12% senior notes and warrants.

 

In this first closing, AMDL sold $1,077,500 of 12% senior notes at par value. The notes mature at the earlier of 24 months or the completion of a bank or credit facility of not less than $8 million in one or more transactions. The warrants included in the offering have a term of five years from the date of issuance and are exercisable at a price equal to $1.00 per share.

 

Under the terms of the offering the exercise price of the warrants are equal to the greater of $1.00 per share or 115% of the five day volume average weighted prices (VWAP) of the Company’s common stock prior to the closing date of the offering.

 

 

AMDL vs. PEERS IN THE UNITED STATES

 

12-15-08

 

Company

Market Cap

       YTD Price    Performance

ADL AMDL, Inc.

12.72M

-80.30%

ABT Abbott Laboratories

80.68B

-7.39%

BAX Baxter International Inc.

32.78B

-8.91%

BEC Beckman Coulter, Inc.

2.62B

-43.32%

BIO Bio-Rad Laboratories, Inc.

1.52B

-33.5%

 

Figure 3

 

 

 

AMDL vs. PEERS IN THE UNITED STATES

 

12-15-08

Company

Market Cap

       YTD Price    Performance

ADL AMDL, Inc.

12.72M

-80.30%

ABT Abbott Laboratories

80.68B

-7.39%

BAX Baxter International Inc.

32.78B

-8.91%

BEC Beckman Coulter, Inc.

2.62B

-43.32%

BIO Bio-Rad Laboratories, Inc.

1.52B

-33.5%

 

Figure 4

 

 

 



SEGMENT REVENUE BREAKDOWN

 

 

The following is information for the Company’s reportable segments for the nine months ended September 30, 2008:

 

 

China-Wholesale

        China-Direct 

    Corporate    

         Total        

Net revenue

           $ 18,419,796

  $  128,629

$          66,568

$  18,614,993

Gross profit

           $ 9,353,246

  $  128,629

$          48,801

$     9,530,676

Net income (loss)

           $ 6,514,770

  $  128,629

$   (6,976,024)

$       (332,625)

Identifiable assets

           $ 34,892,315

  $            

$    5,041,800

$  39,934,115

 

The following is information for the Company’s reportable segments for the three months ended September 30, 2008:

 

 

   China-Wholesale

  China-Direct

    Corporate    

        Total      

Net revenue

  $  9,171,732

   $  43,777

$          30,906

$     9,246,415

Gross profit

  $  4,789,893

   $  43,777

$          22,172

$     4,855,842

Net income (loss)

  $  3,701,500

   $  43,777

$   (2,176,139)

$     1,569,138

 

In 2007, the Company had two reportable segments, (i) manufacturing and wholesale distribution to distributors, hospitals, clinics and similar institutional entities in China (“China-Wholesale”); and (ii) sales to distributors and institutional entities in the U.S. (“Corporate”).

 

The following is information for the Company’s reportable segments for the nine months ended September 30, 2007:

 

 

  China-Wholesale

  China-Direct

    Corporate    

         Total        

Net revenue

    $  9,513,272

   $  39,084

$          93,700

$    9,646,056

Gross profit

    $  5,344,500

   $  39,084

$          76,421

$    5,460,005

Net income (loss)

    $  2,787,289

   $  39,084

$   (6,092,976)

$   (3,266,603)

 

The following is information for the Company’s reportable segments for the three months ended September 30, 2007:

 

 

  China-Wholesale

  China-Direct

    Corporate    

        Total      

Net revenue

    $  5,736,192

   $  39,084

$          33,100

 $     5,808,376

Gross profit

    $  3,518,805

   $  39,084

$          23,795

 $     3,581,684

Net income (loss)

    $  2,280,950

   $  39,084

$   (1,936,926)

 $        383,108

 

Figure 5


 

OUR OPINION

 

At this point in time, we are forecasting that AMDL will end its 2008 fiscal year with net revenues of between $27 and $29 million and net earnings before foreign currency translation of $1.5 million.

 

AMDL has stated on numerous occasions that its goal is to double revenues every year and they have been on target to do so. Independent of the company’s stated goal, our forecast for fiscal year 2009 is that sales in China will be approximately $60 million. Based on a historical net profit margin of about 17%, we would expect that AMDL’s China operation will generate net earnings before currency translation of about $10.2 million, or about $0.64 per share based on 15.9 million shares outstanding.

 

Based on our discussions with management, we have estimated the revenue per kit on a large volume to be $249 with a cost of sales per kit estimated at $45.  Furthermore, most of the corporate overhead is already covered by JPI operations. Since JPI’s operation is the majority of AMDL’s revenues, G & A for the most part would be allocated to JPI.

 

We are currently estimating that AMDL will sell approximately 30,000 DR-70® kits in 2009. When you consider that there is estimated to be 150,000 new cases colorectal cancer just in the United States alone, our estimate would be extremely conservative if were not for the time required to actually build the distribution pipeline and the limited availability of product.

 

Therefore, at this point in time, we believe that DR-70® will result in about $4.48 million in gross revenue during 2009, of which at least $3 million will fall to the bottom line, thereby providing about $0.19 per share in 2009, assuming a weighted average of about 15.9 million shares.

 

Therefore, we are currently estimating that AMDL’s total net revenues for 2009 to be about $60.5 million with earnings for 2009 of about $13.2 million, or about $0.83 per share based on a weighted average of about 15.9 million shares. Using a conservative multiple of 6 times earnings, results in a 2009 target for AMDL’s shares of $5.00 per share.

 

Furthermore, we want to stress that we believe that if AMDL performs in accordance with our projections, the market will allow the company a higher multiple than the 6 given that the company will at that point be within radar range of many institutional investors.

 

 

FINANCIAL STATEMENTS

 

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)

 

 

 

 

             Three Months Ended September 30           

              Nine Months Ended September 30            

 

                    2008                   

                    2007                   

                    2008                   

                    2007                   

 

Gross revenues

     $  12,398,356

     $     5,808,376

     $  21,766,934

     $     9,646,056

Sales promotion discounts

            3,151,941

                         

            3,151,941

                         

Net revenues

            9,246,415

            5,808,376

         18,614,993

            9,646,056

Cost of sales

            4,390,573

            2,226,692

            9,084,317

            4,186,051

Gross profit

            4,855,842

            3,581,684

            9,530,676

            5,460,005

Operating expenses:

                             

                             

                             

                             

Research and development

                 35,032

                    2,407

               100,779

                 15,534

Selling, general and administrative

            2,565,233

            3,090,059

            8,279,758

            8,330,604

 

            2,600,265

            3,092,466

            8,380,537

            8,346,138

Income (loss) from operations

            2,255,577

               489,218

            1,150,139

           (2,886,133)

Other income (expense):

                             

                             

                             

                             

Interest and other income (expense), net

                    9,449

                       441

                (56,052)

                    3,729

Interest expense

                (82,821)

                (87,081)

              (272,926)

              (276,045)

Total other expense, net

                (73,372)

                (86,640)

              (328,978)

              (272,316)

Income (loss) before provision for income taxes

            2,182,205

               402,578

               821,161

          (3,158,449)

Provision for income taxes

               613,067

                  19,470

            1,153,786

               108,154

Net income (loss)

            1,569,138

               383,108

              (332,625)

          (3,266,603)

Other comprehensive gain (loss):

                             

                             

                             

                             

Foreign currency translation gain

                  64,974

               247,918

            1,372,221

               591,254

Comprehensive gain (loss)

     $     1,634,112

     $        631,026

     $     1,039,596

     $   (2,675,349)

Basic income (loss) per common share

     $               0.10

     $               0.03

     $              (0.02)

     $              (0.29)

Diluted income (loss) per common share

     $               0.09

     $               0.03

     $              (0.02)

     $              (0.29)

Weighted average common shares
outstanding — basic

          15,777,119

          12,550,666

          15,508,848

          11,357,055

Weighted average common shares
outstanding — diluted

          17,988,069

          12,773,521

          15,508,848

          11,357,055

 

 

 

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

 

 

                  September 30,   2008               

                   December 31, 2007  

 

 

                                 (Unaudited)

                        (Audited)

 

ASSETS

                   

                   

 

Current assets:

   

   

Cash and cash equivalents

$  3,357,071

$  6,157,493

Accounts receivable, net

    10,531,356

    2,954,902

Related party receivable

    451,038

   

Inventories

    1,189,877

    921,135

Prepaid consulting

    634,043

    872,688

Prepaid expenses and other current assets

    860,088

    1,248,637

Total current assets

    17,023,473

    12,154,855

Property and equipment, net

    13,573,089

    11,672,462

Intangible assets, net

    5,490,632

    5,615,312

Other assets

    3,846,921

    3,424,549

Total assets

 

$  39,934,115

$  32,867,178

LIABILITIES AND STOCKHOLDERS’ EQUITY

   

   

Current liabilities:

   

   

Accounts payable and accrued expenses

$  3,349,228

$  1,676,347

Related party payable

    133,331

    62,621

Deferred revenue

    131,289

    246,758

Current maturities of notes payable

    3,128,602

    5,159,939

Total current liabilities

    6,742,450

    7,145,665

Notes payable, net of current maturities (Note 7)

   

   

Commitments and contingencies

 

   

   

STOCKHOLDER’S EQUITY

   

   

Preferred stock, $0.001 par value; 25,000,000 shares authorized; none issued and outstanding

   

   

Common stock, $0.001 par value; 100,000,000 shares authorized; 16,006,074 and 15,079,528 shares issued at September 30, 2008 and December 31, 2007, respectively; 15,906,074 and 14,979,528 shares outstanding at September 30, 2008 and December 31, 2007, respectively

    15,906

    14,980

Additional paid-in capital

    67,954,631

    61,525,001

Accumulated other comprehensive income

    2,440,650

    1,068,429

Accumulated deficit

    (37,219,522)

    (36,886,897)

Total stockholders’ equity

    33,191,665

    25,721,513

Total liabilities and stockholders’ equity

$  39,934,115

$  32,867,178



 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)



 

Three Months Ended September 30,

Nine Months Ended September 30,

 

             2008           

             2007            

             2008           

             2007           

 

Gross revenues

     $  12,398,356

     $     5,808,376

     $  21,766,934

     $     9,646,056

Sales promotion discounts

            3,151,941

                         

            3,151,941

                         

Net revenues

            9,246,415

            5,808,376

         18,614,993

            9,646,056

Cost of sales

            4,390,573

            2,226,692

            9,084,317

            4,186,051

Gross profit

            4,855,842

            3,581,684

            9,530,676

            5,460,005

Operating expenses:

                             

                             

                             

                             

Research and development

                 35,032

                    2,407

               100,779

                 15,534

Selling, general and administrative

            2,565,233

            3,090,059

            8,279,758

            8,330,604

 

            2,600,265

            3,092,466

            8,380,537

            8,346,138

Income (loss) from operations

            2,255,577

               489,218

            1,150,139

           (2,886,133)

Other income (expense):

                             

                             

                             

                             

Interest and other income (expense), net

                    9,449

                       441

                (56,052)

                    3,729

Interest expense

                (82,821)

                (87,081)

              (272,926)

              (276,045)

Total other expense, net

                (73,372)

                (86,640)

              (328,978)

              (272,316)

Income (loss) before provision for income taxes

            2,182,205

               402,578

               821,161

          (3,158,449)

Provision for income taxes

               613,067

                  19,470

            1,153,786

               108,154

Net income (loss)

            1,569,138

               383,108

              (332,625)

          (3,266,603)

Other comprehensive gain (loss):

                             

                             

                             

                             

Foreign currency translation gain

                  64,974

               247,918

            1,372,221

               591,254

Comprehensive gain (loss)

     $     1,634,112

     $        631,026

     $     1,039,596

     $   (2,675,349)

Basic income (loss) per common share

     $               0.10

     $               0.03

     $              (0.02)

     $              (0.29)

Diluted income (loss) per common share

     $               0.09

     $               0.03

     $              (0.02)

     $              (0.29)

Weighted average common shares
outstanding — basic

          15,777,119

          12,550,666

          15,508,848

          11,357,055

Weighted average common shares
outstanding — diluted

          17,988,069

          12,773,521

          15,508,848

          11,357,055





AMDL, Inc.

2492 Walnut Avenue

Suite 100

Tustin, CA 92780

 

Douglas MacLellan CEO

 

http://www.amdl.com

 

                               

Market Capitalization: (as of 12/15/08)                                                       $12.7 million

Weighted Average Shares Outstanding: (as of 12/15/08)                         15.9 million

                                                               

 

Disclaimer

 

This disclaimer is an integral part of our service. Please read it before investing in any security on which we report. Opinions are solely those of the staff of The Rudd Report and are subject to change without notice. Our reports are for information only and we do not offer securities or solicit the offer of securities of any company. Our reports are to inform the public and not to promote any company or its securities. We do not inform any company in advance of the nature or conclusions of our reports nor can a company change what we write. In the case of AMDL we received a fee for coverage up through December 31, 2008 in the amount of $18,000. Our reports contain factual statements and opinions. We derive these factual statements from sources that we believe are accurate. However, we do not represent that the facts presented are accurate or complete. Furthermore, the information contained in this report may become inaccurate because of the passage of time and should therefore be read for historical information only.