Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
The following discussion should be read in conjunction with the Consolidated Financial Statements and Notes thereto appearing elsewhere in this Form 10-Q. The following discussion contains 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 relating to future events or our future performance. Actual results may materially differ from those projected in the forward-looking statements as a result of certain risks and uncertainties set forth in this prospectus. Although management believes that the assumptions made and expectations reflected in the forward-looking statements are reasonable, there is no assurance that the underlying assumptions will, in fact, prove to be correct or that actual results will not be different from expectations expressed in this report.
Expanding the product line:
Medical International Technology Inc. has been considerably expanding financial resources in R&D in the last 5 years, having spent several millions of dollars. MIT already has 5 products for the human market and 9 products for the animal market. The company will soon be unveiling two new additions to its human product line and one for its animal line.
MIT's patented technology has received approval in several countries worldwide. These three new products are no exception.
The company is refocusing their efforts and will target FDA approval for 2 of its latest product line first; the Home use injector for diabetics and other treatments requiring daily injections, the second product will target the physicians in their clinics, for vaccination and other biological injection medications. The FDA approval for these 2 products will help the company's credibility all over the world.
MIT products pipeline is already defined for 2010/2011; the realization of these new products design will be achieved by new finance to MIT and or a partnership with Medical and Pharmaceutical Companies.
New products for human diabetes, dentistry and poultry applications and their market potentials:
The International Diabetes Federation states that the diagnosis rate of diabetes has increased over the last two decades from 30 million to 246 million people with a disproportionate ratio coming from the United States, India, and China.
Medical International Technology Inc. is targeting this huge market with their newly developed Med-Jet model MIT-P-I within the next 8 to 10 month. "With our successful Chinese joint venture, MIT intends to introduce this new product in China first, thereafter we will have enough production capacity to sell all over the world", said Mr. Karim Menassa. The Med-Jet MIT-P-I is designed to be safe, precise, accurate, effective, easy to use and friendly to the environment.
Medical International Technology, Inc.
According to the World Health Organization (WHO) statistics, last updated 26 October 2004, the number of dentists in the world was numbered in the millions. There are 234,104 registered Dentist in the USA, 18,861 in Canada, 50,920 in China and it is estimated that 400,000 will be needed by 2030. Statistics show there is an estimated average of 6 to 10 dentists for every 10,000 people in Europe.
It is estimated that 150,000 U.S. dentists could administer about 250 million doses of local Anaesthetics per year for the gums, for a total market of about $3.5 billion.
Medical International Technology Inc. is targeting this lucrative market with their Med-Jet model MIT-H-VI within the next 12 to 16 month. MIT intends to introduce this new product in North America first; other countries will follow shortly after. In the Dental Office, painful needle injections are enough to make even the most rational person skip dental visits. The Med-Jet MIT-H-VI will finally bring an end to traumatic dental visits.
MIT's newly designed Agro-Jet model MIT-XII will help prevent the spread of deadly diseases by providing a needle-free alternative to the vaccination of billions of day-old baby chicks yearly. This high speed vaccinator will be able to inject thousands of birds per hour safely, precisely, accurately, effectively, with ease of use and friendly to the environment.
Chinese Joint Venture:
On May 6, 2009, the Company entered into a certain joint venture agreement (the "Joint Venture Agreement") with Jiangsu Hualan Biotechnology Ltd. (China) ("Jiangsu Hualan"). Pursuant to the Joint Venture Agreement, the parties established a joint venture company, Jiangsu Hualan MIT Medical Technology (MIT China) Ltd. ("MIT China" or the "Joint Venture"), focusing on research, production and sales of medical equipments, import and export of medical equipments and components products, especially Needle-Free Jet Injector products. The total investment by the Joint Venture shall amount to $2,000,000, and the registered capital shall amount to $1,400,000. The Company invested cash of $426,678 and transferred the license rights to produce and sell the Company's needle-free injectors products into the Joint Venture. The license rights were valued at $280,000 under the agreement. The contributions by the Company resulted in the Company owning 49% of the registered capital of the Joint Venture. Jiangsu Hualan contributed cash of $714,000, and owns 51% of the registered capital.
Under the agreement, the Company appointed 1 member to the Board of Directors of the Joint Venture and Jiangsu Hualan appointed 2 members to the Board of Directors. Profits of the Joint Venture will be paid based each parties investment in the registered capital.
Projected Sales and Market Breakdown
On February 6, 2010, we announced in our Corporate Update that the company firmly believes it will grow revenues well past $75,000,000 annually within the next three years. The following information will outline market expectations by category and timeframe:
Our initial target market for the first year is cosmetic Dermatology, Plastic surgery, and General Practitioner for single and mass injections, using Med-Jet models MIT MBX and MIT-H-III. The second year, in addition to the previous models, the introduction of model MIT-H-IV-1 and MIT-H-IV-5 will target private clinics and hospitals. During the third year, the injector for Diabetics, MIT P-I, and the Dental injector, MIT-H-VI, will be introduced and will drastically increase sales to achieve and exceed its forecasted $55,000,000.
Our initial target market for the first year is the pork, cattle, and poultry markets, using our existing and newly redesigned products for mass animal vaccination. The second year in addition to the previous models, MIT will introduce and market its day-old baby chicken injector, a highly-requested product by farmers around the world. During the third year, MIT will present 2 more new products expected to drastically increase sales to achieve and exceed its forecasted $20,000,000.
Medical International Technology, Inc.
Since its establishment in 1990, Jiangyin Lanling Bottle Stoppers Co., Ltd. (one of the members of Hualan Group) has grown to be the leading medical packaging material manufacturer in China with an extensive product range, unparalleled manufacturing scale, leading edge technologies and national recognition as a highly-valued technology enterprise. Lanling is also the leading butyl rubber stopper producer in the Asia Pacific region. Mr. Hua Guoping, President and Chairman of Hualan Group, will be working with Medical International Technology.
China joint venture
The creation of MIT China in June of 2009 has given MIT a unique advantage to expand its production operations and increase its sales and profits in the multi-billion dollar worldwide needle-free injector market. Furthermore, MIT China venture will help Medical International Technology Inc. supply large production volumes in lesser time, which will attract large medical and pharmaceutical partners.
The introduction of our Agro-Jet needle-free injector for animal application is going very well; our veterinary staff is doing an excellent job training our Distributors in the different provinces. These efforts will result in sales growth for the coming months and years.
The construction of a class 10,000 clean room lab, recommended by the SFDA, was completed on January 29, 2010. Having received certification for our production facilities earlier this week brings us a step closer to our goal of beginning production of our Med-Jet line of products and all the disposable accessories in China for the Chinese market.
Our goal is to complete our clinical trials of Med-Jet models MIT-MBX and MIT-H-III in June of 2010 and start marketing and selling in July 2010.
Our objective is to ensure that our injectors become an indispensable, environmentally friendly product for doctors, dentists, veterinarians and home users around the world.
We will continue providing a safe and effective means to help prevent the spread of deadly diseases to both humans and animals through the use of the Med-Jet� and Agro-Jet� needle-free injection system.
Medical International Technology, Inc.
Results of Operations
Results of Operations for the Nine-Months ended June 30, 2010 and 2009
For the nine-month period ended June 30, 2010, the Company experienced a net loss from operations of $765,203 which was primarily due to research and development costs of $141,678 and selling, general and administrative expenses of $897,458. Gross profits for the period were $350,922.
For the nine-month period ended June 30, 2009, the Company experienced a net loss from operations of $1,674,452 which was primarily due to research and development costs of $1,481,373 and selling, general and administrative expenses of $437,323. Gross profits for the period were $244,396.
The reduced net loss between the comparable quarters was due to increased sales as the Company continues to push its products into the market along with reduced research and development costs. Sales for the nine-month period ending June 30, 2010 were $514,893 compared to sales of $392,977 for the same period last year. Gross profits for the period ending June 30, 2010 represented 68% of sales, where gross profits for the same period last year represented 62% of sales. This is primarily a result of the Company experiencing more steady sales beginning in the last quarter of fiscal 2010. Research and development costs decreased primarily as a result of the expiration of the Idee contract, which is currently on a month to month basis.
Liquidity and Capital Resources
For the nine-month period ending June 30, 2010, the Company's cash position increased to $109,892. Net cash used in operating activities was $2,689,090. Primarily as a result of the Company's net loss offset by common stock issued for services of $333,400 and capitalization of related party debt of $3,403,982. Financing activities provided $3,061,970 which was primarily as a result of decreases in amounts due to related parties of 3,156,564 and cash received of $100,000 from issuance of common stock. Cash used by investing activities was $20,606, which was additional capital invested in the MIT China joint venture and acquisitions of new patent rights. The effect of exchange rates on cash increased cash balances by $425,997.
For the nine-month period ending June 30, 2009, the Company's cash position was $100,109. Net cash used in operating activities was $1,063,987, primarily due to the Company's net loss during the period. Financing activities provided $1,941,405, entirely from increased borrowings from related parties. The effect of exchange rates on cash increased cash balances by $73,957.
Plan of Operations
We are engaged in the business of research, development, marketing and sales of needle-free jet injector technology and products for humans and animals, for single and mass injections.
We continue to market our product in all available markets, seek regulatory approvals to expand those market opportunities and improve our products for application to new markets.
The creation of a multi-functional Advisory Board, composed of individuals from diverse backgrounds, is serving to strengthen the management of Medical International Technology Inc. in support to the President and Chief Executive Officer Mr. Karim Menassa. Our goal is to increase efficiency and take further advantage of the opportunities ahead in the global market of needle-free jet-injector for human and animal applications.
We will continue to seek additional funding to expand operations, develop sales revenue, conduct presentation to Medical and Pharmaceutical Companies, achieve sales to a volume sufficient to sustain operations and yield a good return to our shareholders.
Medical International Technology, Inc.
As per our previous fillings for FDA approval for its needle-free injector - the MED-JET, designed specifically for human mass inoculations. The MED-JET is capable of delivering many types of medications such as vaccines, insulin and other types of injectables. Its low-pressure technology offers an advantage to alternative high pressure systems that can cause blowbacks and expose medical workers and patients alike to microscopic traces of blood.
According to the International Sharps Injury Prevention Society (http://www.isips.org), it has been estimated that one out of every seven workers is accidentally struck by a contaminated sharp point each and every year. The Center for Disease Control (CDC:
http://www.cdc.gov/niosh/2000-108.html#5) estimates that there are 600,000 to 800,000 needle stick injuries per year in the U.S. alone, and many are not reported. More than 20 types of infectious agents have been transmitted through needlesticks, including hepatitis B and C, tuberculosis, syphilis, malaria, herpes, diphtheria, gonorrhea, typhus and Rocky Mountain spotted fever. The MED-JET will eliminate this risk to our health care professionals and create a safer workplace. Other advantages include its light weight (0.5 kg) and an excellent medication absorption rate. Additionally, the system has the ability to increase or decrease the volume and pressure of injection. This technology is unique to MIT's MED-JET MBX Injector. The system is designed to inject up to 600 individuals an hour.
The approval process can be expensive and may take extended period of time. There can be no assurance that this system will receive approval from the FDA or if approved gain broad acceptance by the medical community or individual patients.
On December 15, 2005, we received full certification granted under the International Organization for Standardization, as well as the Canadian Medical Device Conformity Assessment System, for devices to be licensed by HEALTH CANADA. These certifications allow MIT to market the Med-Jet Needle-Free Injector for human use in all countries other than the U.S., at this point. The Med-Jet injector has been submitted for FDA approval which, if accepted, will allow MIT to sell the Med-Jet in the United States, making it a truly worldwide system.
MIT's Needle-Free Injection System, designed specifically to allow fast, accurate and safe injections, is rapidly moving toward establishing itself as a valuable instrument in the fight against disease in both humans and animals. Spurred on by growing fears of a world wide epidemic that could match or even exceed the deadly flu pandemic of 1918, which killed millions of people, the MIT team is focusing its efforts to make its Needle-Free Injection System available to the world.
Now that MIT is able to sell its Med-Jet in all countries, other than the U.S., it is working to complete two FDA filings. The first of these will be for use of the Med-Jet for injecting anesthesia in a variety of situations. The second, and most significant in light of the news coming out of Asia concerning the spread of Influenza A (H1N1) to humans, will be the Med-Jet-H III, for mass vaccination in case of a pandemic, such as Avian Influenza, Polio, Tuberculosis, Malaria or HIV.
MIT is also pursuing increasing interest in its Agro-Jet needle-free injector. Having the same benefits as Med-Jet, Agro-Jet will become a valuable instrument in the fight against Avian Flu via its ability to mass inoculate animals at over 1000 injections per hour.
On December 22, 2005 we announced that as part of its continuing restructuring program MIT is forming two divisions. The Human Medical Technology Division will focus on the development, production, marketing and sale of needle-free injectors and other medical technologies for humans. The Animal Medical Technology Division will deal with all aspects of the development, production, marketing and sale of the needle-free injectors and other technologies for animal applications worldwide.
Off Balance Sheet Arrangements
We have no significant off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to our stockholders.