This quarterly report on Form 10-Q and other reports filed by Registrant from time to time with the Securities and Exchange Commission (collectively the "Filings") contain or may contain forward-looking statements and information that are based upon beliefs of, and information currently available to, Registrant's management as well as estimates and assumptions made by Registrant's management. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. When used in the filings, the words "anticipate", "believe", "estimate", "expect", "future", "intend", "plan", or the negative of these terms and similar expressions as they relate to Registrant or Registrant's management identify forward-looking statements. Such statements reflect the current view of Registrant with respect to future events and are subject to risks, uncertainties, assumptions, and other factors (including the risks contained in the section of this report entitled "Risk Factors") relating to Registrant's industry, Registrant's operations and results of operations, and any businesses that Registrant may acquire. Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned.
Although Registrant believes that the expectations reflected in the forward-looking statements are reasonable, Registrant cannot guarantee future results, levels of activity, performance, or achievements. Except as required by applicable law, including the securities laws of the United States, the Registrant does not intend to update any of the forward-looking statements to conform these statements to actual results. Readers are urged to carefully review and consider the various disclosures made throughout the entirety of this quarterly report, which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operations, and prospects.
Financial Summary
Results of Operations for the Nine-Months ended June 30, 2009 and 2008
For the nine-month period ended June 30, 2009, the Company experienced a net loss from operations of $1,674,300 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.
For the nine-month period ended June 30, 2008, the Company's net loss from operations was $696,361, which was primarily due to research and development costs of $102,063 and selling, general and administrative expenses of $763,372. Gross profits for this period were $169,074.
For the nine-months ended June 30, 2009, the Company experienced an increase in sales compared to sales for the same period last year. Sales for the nine-month period ending June 30, 2009 were $392,977 compared to sales of $306,060 for the same period last year. Gross profits for the none-month period ending June 30, 2009 represented 62% of sales, where gross profits for the same period last year represented 55% of sales.
Results of Operations for the Three-Months ended June 30, 2009 and 2008
For the three-month period ended June 30, 2009, the Company experienced a net loss from operations of $581,218 which was primarily due to research and development costs of $581,373 and selling, general and administrative expenses of $171,085. Gross profits for the period were $171,240.
For the three-month period ended June 30, 2008, the Company's net loss from operations was $245,380, which was primarily due to research and development costs of $78,990 and selling, general and administrative expenses of $427,268. Gross profits for this period were $02,898.
For the three-months ended June 30, 2009, the Company experienced an increase in sales compared to sales for the same period last year. Sales for the three-month period ending June 30, 2009 were $234,060 compared to sales of $140,553 for the same period last year. Gross profits for the three-month period ending June 30, 2009 represented 73% of sales, where gross profits for the same period last year represented 73% of sales.
Liquidity and Capital Resources
For the nine-month period ending June 30, 2009, the Company's cash position increased $5,275. Net cash used in operating activities was $950,068; financing activities provided $885,762; and the effect of exchange rates on cash provided $69,581.
For the nine-month period ending June 30, 2008, the Company's cash position increased $11,507. Net cash used in operating activities was $617,133; financing activities provided $326,052; and the effect of exchange rates on cash provided $276,151.
Management Plan of Operations
Medical International Technology, Inc. ("MIT") is 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.
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.
Medical International Technology, Inc. will continue to seek additional funding to expand operations and develop sales revenue to a volume sufficient to sustain operations.
Product Development
Medical International Technologies is still working towards getting FDA approval for its needle-free injector, few more test are required and are being planned - 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 stuck 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, Medical International Technologies, Inc announced that it has 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., MIT is working towards getting FDA approval, more test are required and are being planned at this point. The Med-Jet injector will be submitted for FDA approval as soon as we complete the required testing 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 pandemic 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 the 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 Mexico and USA and other countries around the world 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 many diseases such as Swine Flue and Avian Flu via its ability to mass inoculate animals at over 1000 injections per hour.
