UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
x | ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended June 30, 2011 | |
o | TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number 0-24635
Hypertension Diagnostics, Inc.
(Exact Name of Registrant as Specified in Its Charter)
Minnesota (State or Other Jurisdiction of Incorporation or Organization) | 41-1618036 |
(I.R.S. Employer | |
Identification No.) |
10275 Wayzata Blvd, Suite 310, Minnetonka, MN 55305
(Address of Principal Executive Offices, including Zip Code)
Registrant’s Telephone Number: (952) 545-2457
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered under Section 12(g) of the Exchange Act:
Title of Each Class Title of Each Class Name of Each Exchange on Which Registered
Common Stock ($.01 par value) Redeemable Class B Warrant OTC QB
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes o No x
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.
Yes o No x
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding twelve months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes x No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of Registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendments to this Form 10-K. x
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company x |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o No x
The aggregate market value of voting Common Stock held by non-affiliates of the Registrant, based upon the average of the closing bid and ask price of Common Stock on the OTCQB, the middle tier of the OTC market on September 15, 2011 of $0.09 was approximately $2,843,082.
There were 43,325,843 shares of the issuer’s common stock, $.01 par value per share, outstanding as of September 15, 2011.
DOCUMENTS INCORPORATED BY REFERENCE
None.
Hypertension Diagnostics, Inc.
Annual Report on Form 10-K
For the Year Ended June 30, 2011
INDEX
PART I | 2 |
ITEM 1. Business | 2 |
ITEM 1A. Risk Factors | 11 |
ITEM 2. Properties | 17 |
ITEM 3. Legal Proceedings | 17 |
PART II | 18 |
ITEM 5. Market for Common Equity and Related Stockholder Matters and Issuer Purchases of | |
Equity Securities | 18 |
ITEM 6. Selected Financial Data | 18 |
ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations | 18 |
ITEM 8. Financial Statements and Supplementary Data | 25 |
ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 43 |
ITEM 9A. Controls and Procedures | 43 |
ITEM 9B. Other Information | 43 |
PART III | 43 |
ITEM 10 Directors, Executive Officers and Corporate Governance | 43 |
ITEM 11 Executive Compensation | 45 |
ITEM 12 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 48 |
ITEM 13. Certain Relationships and Related Transactions | 50 |
ITEM 14. Principal Accountant Fees and Services | 50 |
PART IV | 51 |
ITEM 15. Exhibits, Financial Statement Schedules | 51 |
SIGNATURES | 52 |
Forward-Looking Statements
This Annual Report and our public documents to which we refer contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. In addition, we may make forward-looking statements orally in the future by or on behalf of the Company. When used, the words “believe,” “expect,” “can,” “estimate,” “anticipate” and similar expressions are intended to identify forward-looking statements. We caution readers not to place undue reliance on any forward-looking statements and to recognize that the statements are not predictions of actual future results. Actual results could differ materially from those anticipated in the forward-looking statements due to the risks and uncertainties set forth herein under the caption “Risk Factors,” as well as others not now anticipated.
These risks and uncertainties include, without limitation: our ability to develop a business model to timely generate acceptable levels of revenues; negative effect on our stock price resulting from available securities for sale; our need for additional capital; our dependence on our CVProfilor® DO-2020; the availability of third-party reimbursements for the use of our products; increased market acceptance of our products; our marketing strategy may result in lower revenues; the illiquidity of our securities on the OTCQB, the middle tier of the OTC market and the related restrictions on our securities relating to “penny stocks”; potential violations by us of federal and state securities laws; the availability of integral components for our products; our ability to develop distribution channels; increased competition; changes in government regulation; health care reforms; exposure to potential product liability; our ability to protect our proprietary technology; regulatory restrictions pertaining to data privacy issues in utilizing the CDMF; and the ability to manufacture our products on a commercial scale and in compliance with regulatory requirements.
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PART I
Introduction
We were incorporated under the laws of the state of Minnesota on July 19, 1988. We are engaged in the design, development, manufacture and marketing of proprietary devices that non-invasively measure both large and small artery elasticity. Vascular compliance or arterial elasticity is an early indicator of vascular disease. Our product provides important cardiovascular parameters which we believe provide clinically beneficial information useful in screening patients who may be at risk for future cardiovascular disease, provide assistance to physicians with their diagnosis of patients’ cardiovascular disease, and allow for monitoring the effectiveness of various treatments of patients with diagnosed cardiovascular disease.
ITEM 1. Business
We market three products:
CVProfilor® DO-2020 CardioVascular Profiling System. The CVProfilor® DO-2020 System has been approved by the Food and Drug Administration, or FDA, and is marketed to primary care physicians and other health care professionals within the United States. These physicians and other health care professionals can purchase the CVProfilor® DO-2020 directly from us or lease it through a third-party capital lease.
HDI/PulseWave™CR-2000 Research CardioVascular Profiling System. The CR-2000 Research System is being marketed “for research purposes only” to clinical research investigators for the purpose of collecting data in cardiovascular studies.
CVProfilor® MD-3000 CardioVascular Profiling System. The CVProfilor® MD-3000 System is the international version of the CVProfilor® DO-2020 System designed for physicians outside the United States.
Background of Business
Cardiovascular Disease
Cardiovascular disease is the primary cause of heart attacks and strokes and is the leading cause of death worldwide. The disease can manifest itself in many ways, including: hypertension or high blood pressure, coronary artery disease leading to heart attacks, peripheral artery disease, arteriosclerosis (hardening of the arteries) or atherosclerosis (plaque which progressively blocks arteries), aneurysm, stroke, kidney failure, retinopathy and sudden death.
Hypertension, typically defined as blood pressure measuring 140 mmHg or greater systolic pressure and/or 90 mmHg or greater diastolic pressure, is extremely common. According to the American Heart Association, in an estimated 1 in 3 adults in the United Sates aged 18 or older have hypertension. Almost a third of this population is not aware that it has hypertension. Among individuals receiving treatment, nearly 55% have uncontrolled hypertension. In other words, approximately 55% of these individuals are not being properly treated for their high blood pressure and, therefore, face significantly higher increased risk for advanced heart and kidney disease and the occurrence of strokes. According to the National, Heart, Lung, and Blood Institute more than $100 billion is spent in the United States each year on hypertension and its associated complications.
In recognition of the health risks posed by high blood pressure, the AHA issued guidelines that classify individuals with systolic blood pressure between 120-139 mmHg or diastolic blood pressure between 80-89 mmHg as “prehypertensive.” The AHA estimates that an additional 53 to 82 million American adults over the age of 18 have “prehypertension.” Prehypertensive individuals are believed to be at significant risk for developing hypertension and they have a much greater risk of cardiovascular events or dying from cardiovascular disease within 10 years than people with lower or normal blood pressure levels.
Hypertension can easily go undetected and has been called the “silent killer” because it usually produces no clinical symptoms until after it has already seriously damaged the heart, kidneys, brain and/or other vital organs. Hypertension damages the arteries, leading to pathological changes in the tissues and organs supplied by these damaged arteries. It accelerates the development of atherosclerosis in large blood vessels and in the arteries supplying blood to the brain, heart, kidneys and legs. Atherosclerosis is the formation of plaque and the accumulation of fatty deposits lining the walls of arteries, or endothelium, which affect blood flow. The endothelium helps to maintain the flexibility or elasticity of the artery and normally inhibits the accumulation of lipid and cellular deposits on the wall of the artery. Abnormal function of the endothelium and the associated structural changes in the blood vessel wall result in a progressive loss of elasticity of the arteries. Detection of this loss in elasticity can identify individuals with abnormal arterial structure and function, often long before plaque formation can cause morbid cardiovascular events such as heart attacks or strokes. Further, demonstration of normal arterial structure and function might suggest that an individual does not have early atherosclerosis and therefore may not need aggressive risk factor management, despite poor life styles such as obesity, smoking or inactivity.
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There is no simple, clinically applicable method to detect the presence of atherosclerosis prior to plaque obstruction of the arteries leading to heart attack, stroke, angina and other cardiovascular diseases. We believe there have been widespread, global efforts at identification of individuals exhibiting the risk factors associated with atherosclerosis and intervention through lifestyle modification, medical therapy, surgical procedures and medication. We believe the problem with this approach is two-fold: (a) patients without traditional risk factors will not be identified even though up to many of the atherosclerotic clinical events occur in such individuals; and (b) patients who have one or more risk factors may be subjected to intensive and prolonged therapy even though they may not have the atherosclerotic process which the therapy is designed to inhibit.
The Clinical Problem
Cardiovascular specialists spend considerable effort on evaluating heart function, including the clinical use of electrocardiograms (ECGs), echocardiograms and stress tests, but have been unable to assess the functional and structural abnormality of the arteries prior to the late phase of arterial obstruction due to atherosclerosis. In addition, due to the fact that hypertension increases one’s risk for developing cardiovascular disease, physicians put considerable effort into blood pressure measurements even though it, too, is an insensitive and nonspecific means of assessing the underlying condition of the blood vessels. Traditionally, a patient’s arterial blood pressure is obtained clinically by using a sphygmomanometer, that is, an upper-arm blood pressure cuff device. Despite these attempts to identify patients at risk for cardiovascular disease studies show that blood pressure is not necessarily well correlated with actual cardiovascular events. Therefore, focusing on blood pressure levels alone to determine cardiovascular risk may not catch those with actual disease.
Although an elevated blood pressure is associated with a higher risk for cardiovascular events, the elevated blood pressure is not the disease, but merely a relatively crude marker for the likelihood of disease. Furthermore, blood pressure itself is highly variable from moment to moment and day to day in almost all individuals. Elevated serum cholesterol levels, especially an increase in the low-density lipoproteins/high-density lipoproteins (LDL/HDL) ratio, also are associated with a higher risk for morbid cardiovascular events, but this measurement does not identify blood vessel disease directly. Instead, a high LDL/HDL ratio is yet another risk factor (such as smoking or lack of exercise) that might increase the risks associated with blood vessel disease. Various medical techniques such as radiology, magnetic resonance imaging (MRI), computerized tomography (CT) scans and ultrasonography also are not useful in obtaining information about the elasticity of small and/or very small arteries, or arterioles, which are the first blood vessels to become altered with hypertension and other cardiovascular diseases.
The degree of arterial elasticity is related to the condition of the blood vessels, and with declining elasticity comes an increase in the incidence of vascular disease. We believe declining elasticity in the arterial wall precedes the development of overt coronary artery disease by many months and even years. Therefore, the “premature stiffening” of the small arteries and arterioles appears to be an early and sensitive clinical marker for cardiovascular disease, even in patients who have no clinical evidence of traditional risk factors for vascular disease. Further, clinical research data published globally has shown that patients with heart failure, coronary artery disease, hypertension and diabetes all exhibit a loss or reduction of arterial elasticity.
The Company’s Products
Our products capture blood pressure waveform data produced by the beating heart and analyze it in order to provide an assessment of systemic arterial elasticity for both large and very small arteries.
Blood pressure waveform data is produced each time the heart cycles through a complete heartbeat. As the heart contracts pushing a volume of blood into the arteries, pressure within the arteries rise. As the aortic valve closes after the heart has ejected this volume of blood, blood pressure within the arteries falls prior to the next heartbeat. The complete cycle forms a pressure curve or waveform, which reflects the degree or amount of arterial elasticity. Subtle changes in arterial elasticity introduce changes within the entire arterial system that are reflected in this blood pressure waveform or shape. This “blood pressure waveform” or “pulse contour analysis” methodology provides an independent assessment of the elasticity or flexibility of the large arteries which expand briefly as they act as conduits for blood ejected by the heart, and of the small arteries and the arterioles which produce oscillations or reflections in response to the pressure wave generated during each heart beat. The degree of arterial elasticity is related to the condition of the blood vessels and with declining elasticity comes an increase in the incidence of cardiovascular disease.
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Incorporating this physiological phenomenon associated with blood pressure waveforms, Drs. Jay N. Cohn and Stanley M. Finkelstein, Professors at the University of Minnesota Medical School in Minneapolis, Minnesota, and two of our Company’s founders, developed a clinically useful procedure for determining a measure of elasticity for both large and small arteries. Our products use patented and proprietary software programs and algorithms to analyze the contour of the blood pressure waveform so that the arterial elasticity can be determined. The measure of elasticity of the large arteries is called a C1-large artery elasticity index and in the small arteries the measure is called the C2-small artery elasticity index.
The Products
We currently have designed, developed and are marketing three products:
- HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System
- CVProfilor® DO-2020 CardioVascular Profiling System
- CVProfilor® MD-3000 CardioVascular Profiling System
Our products painlessly and non-invasively collect 30 seconds of blood pressure waveform data from the patient. The products analyze this data by means of an embedded computer and then generate a CardioVascular Profile Report or CVProfile™ Report using an external printer. All of our products have four primary components: (a) a custom designed, non-invasive Arterial PulseWave™ Sensor which is positioned over the radial artery at the wrist by means of a special apparatus; (b) an upper-arm blood pressure cuff connected via a hose to an oscillometric blood pressure module within the device; (c) a device enclosure which contains a computer, a high resolution touch-screen display and other electronics and software programs; and (d) an external printer.
HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System
The CR-2000 Research System, first promoted during December of 1998. The CR-2000 Research System is not recognized as a medical device and it is being marketed “for research purposes only” to clinical research investigators for the purpose of collecting data in cardiovascular studies. We have not submitted, and do not intend to submit, an application for the CR-2000 Research System to the FDA for clearance to market it as a medical device for use on patients in the U.S.
The CR-2000 Research System non-invasively collects 30 seconds of blood pressure waveform data, performs an analysis of the digitized blood pressure waveforms, and generates a Research CardioVascular Profile Report that contains 15 cardiovascular parameters (some report parameters are displayed on the screen and the entire report is generated by an external printer). An electronic RS-232 computer output port is standard on all CR-2000 Research Systems so that research scientists and clinical investigators can download the Research CardioVascular Profile Report parameters and waveform data directly to computer systems within their medical centers and research institutions.
The CR-2000 Research System is marketed to pharmaceutical firms, research investigators at academic medical research centers, and government institutes conducting a wide range of cardiovascular disease research.
Five drug manufacturers have permitted the public disclosure of their use of our HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System in their multi-site clinical research trials: Alteon, Inc.; AstraZeneca, LP; Parke-Davis; Pfizer, Inc. and Solvay Pharmaceuticals, Inc. Our CR-2000 Research System was first introduced into the initial 2-year phase of the NHLBI Multi-Ethnic Study of Atherosclerosis, or MESA, research trial in May of 2000. After several years of preparatory efforts, the NHLBI publicly announced the 10-year multicenter study on September 14, 2000. The MESA trial is a prospective clinical study attempting to identify clinically useful markers or parameters for predicting cardiovascular disease before the onset of signs or symptoms. The trial has been designed to be a 10-year investigation of more than 6,000 men and women of many ethnic backgrounds residing throughout the U.S. Each study participant has had his or her C1-large artery elasticity or C-2 small artery elasticity index determined and recorded. Over the remainder of the trial, enrollees will be followed to determine changes in subclinical disease as well as cardiovascular disease morbidity and mortality.
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CVProfilor® DO-2020 CardioVascular Profiling System
On November 1, 2000, the FDA granted us clearance to market the CVProfilor® DO-2020 System as a medical device in the U.S. The CVProfilor® DO-2020 System is currently being promoted to physicians specializing in internal medicine, general and family practice, cardiology, endocrinology, nephrology and to other primary care physicians throughout the U.S.
The CVProfilor® DO-2020 System non-invasively collects 30 seconds of blood pressure waveform data, performs an analysis of the digitized blood pressure waveforms, and generates a CVProfile™ Report. The CVProfile™ Report, printed in the physician’s office using the printer provided as part of the System, contains information on blood pressure (systolic, diastolic and mean arterial pressure), heart rate, pulse pressure, body surface area, body mass index, and both C1-large and C2-small artery elasticity indices.
CVProfilor® MD-3000 CardioVascular Profiling System
An international version of our product, the CVProfilor® MD-3000 CardioVascular Profiling System, was introduced in 2002. The CVProfilor® MD-3000 System is designed for use in physicians’ offices outside the United States to non-invasively assess the health of patients’ large and small arteries for the early detection and management of vascular disease.
Similar to the CVProfilor® DO-2020 System, the CVProfilor® MD-3000 System provides physicians with the ability to immediately print a CVProfile™ Report in their office containing patient specific information on blood pressure (systolic, diastolic and mean arterial pressure), heart rate, pulse pressure, body surface area, body mass index, and both C1-large and C2-small artery elasticity indices. To date, there have been no commercial sales of the MD-3000 to physician or research customers.
CardioVascular Profile (CVProfile™) Report
The Research CardioVascular Profile Report currently generated by the CR-2000 Research System presents the following parameters:
- 1.5 Second Blood Pressure Waveform Graph - Pulse Pressure - Estimated Stroke Volume Index
- Large Artery Elasticity Index - Pulse Rate - Estimated Cardiac Output
- Small Artery Elasticity Index - Estimated Cardiac Ejection Time - Estimated Cardiac Index
- Systolic Blood Pressure - Estimated Stroke Volume - Total Vascular Impedance
- Diastolic Blood Pressure - Body Surface Area - Systemic Vascular Resistance
- Mean Arterial Pressure - Body Mass Index
The CVProfile™ Report currently generated by the CVProfilor® DO-2020 System and the CVProfilor® MD-3000 System presents the following parameters:
- 1.5 Second Blood Pressure Waveform Graph - Mean Arterial Pressure
- C1-Large Artery Elasticity Index - Pulse Pressure
- C2-Small Artery Elasticity Index - Pulse Rate
- Systolic Blood Pressure - Body Mass Index
- Diastolic Blood Pressure - Body Surface Area
Potential Beneficial Medical Outcomes for Patients and Payers
Basic and applied research findings suggest that the arterial elasticity indices can be used to determine the “clinical age” of the body’s arteries and that these values, when viewed in combination with a medical history, physical examination and/or other tests, may provide a meaningful picture of the vascular health for patients of about 15 years of age and older. The C1-large and C2-small artery elasticity indices are of particular clinical importance in such evaluations. These indices indicate the elasticity or flexibility of the patient’s arteries throughout the body, which we believe to be beneficial in assessing vascular disease. These indices also provide valuable information to physicians in screening patients who may be at risk for underlying vascular disease and thereby may have a potential for future life-threatening cardiovascular events.
Clinical research investigators have evaluated thousands of “normal” subjects, as well as many who have cardiovascular disease. They have summarized their data in order to establish the approximate “reference range” for arterial elasticity and other cardiovascular parameters. Patients with normal blood pressure values have been identified who exhibit “premature stiffening” of their small and very small arteries or arterioles. Without the benefit of a CVProfile™ Report, such patients would be considered “clinically normal and asymptomatic.” Thus, we believe that the CVProfilor® DO-2020 System and the CVProfilor® MD-3000 System may help physicians identify such patients and encourage them to modify their lifestyle and/or intervene therapeutically by prescribing medication much earlier in the progression of cardiovascular disease.
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MARKETING, SALES AND DISTRIBUTION
Because of the magnitude and impact cardiovascular disease has on the population, we believe that our products provide an accurate, cost-effective and efficient means with which to screen, risk-stratify and manage patients who may have underlying vascular disease and/or who have been diagnosed with cardiovascular disease.
The Research Market
The CR-2000 Research System is being marketed to pharmaceutical firms, research investigators at academic medical research centers, and government institutes conducting clinical research trials relating to cardiovascular disease and treatment. These organizations are in the business of gathering large amounts of cardiovascular data from human research subjects, non-invasively.
We believe that the CR-2000 Research System provides an innovative means for gathering additional data and information during such critical clinical research endeavors. The clinical research market is diverse, with global pharmaceutical companies, the U.S. federal and foreign governments and medical device manufacturers funding the vast majority of these research endeavors. Therefore, we have been pursuing the following three markets for the CR-2000 Research System:
Pharmaceutical Companies. Pharmaceutical firms often seek new ways to gather additional data and information non-invasively from human subjects engaged in clinical research trials and we actively market to pharmaceutical companies for the inclusion of our CR-2000 Research System in their clinical research trials relating to drugs for the treatment of cardiovascular disease.
Academic Centers. Universities throughout the world conduct clinical research trials, which are financially supported with grants from governmental agencies, disease management foundations and private sponsors. Universities with research centers conducting clinical trials in the areas of preventative cardiology, nephrology and epidemiology are a particular target market for our CR-2000 Research System.
The U.S. Government. The National Institutes of Health, the Veterans’ Affairs Medical Centers, the Agency for Health Care Policy and Research, and the Centers for Disease Control and Prevention often conduct large-scale research projects and clinical trials that represent a significant market opportunity for the CR-2000 Research System.
As of June 30, 2011, the CR-2000 Research System was being utilized in approximately 38 countries throughout the world and users have contributed many of the articles in our bibliography of over 300 published abstracts, articles and presentations that reference either our CR-2000 Research System or our pulse contour analysis methodology. These references not only reinforce the scientific and clinical merit of our arterial waveform analysis methodology, but they broaden the medical community’s understanding of, as well as the clinical application of, employing large and, especially, small artery elasticity indices as early and sensitive markers for the presence of vascular disease in patients.
To date, five pharmaceutical firms and the National Institutes of Health/National Heart, Lung, and Blood Institute, the largest governmental clinical research agency, and the Centers for Disease Control, have allowed us to publicly discuss their use of the CR-2000 Research System for use in multi-site clinical trials.
• Alteon, Inc. used the CR-2000 Research System as part of its Advanced Glycosylation End products (A.G.E.) ‘Crosslink Breaker’ ALT-711 drug trial;
• AstraZeneca, LP used the CR-2000 Research System to obtain additional data in its Trial Of Preventing Hypertension, or TROPHY, study which was designed to investigate whether or not early treatment of subjects with high blood pressure can prevent or at least delay the onset of clinically detectable hypertension;
• The Centers for Disease Control used the CR-2000 Research System to study the effects of pollution on the vasculature;
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• The National Institutes of Health/National Heart, Lung, and Blood Institute used the CR-2000 Research System as one of the primary investigative clinical endpoints for its Multi-Ethnic Study of Atherosclerosis, or MESA, research trial which is a ten-year, multi-site prospective clinical study involving approximately 6,000 subjects of varied ethnic background in an attempt to identify clinically useful procedures for predicting cardiovascular disease;
• Parke-Davis used the CR-2000 Research System for a multi-site cardiovascular drug research trial as part of their ongoing clinical research investigations;
• Pfizer, Inc. used the CR-2000 Research System for a North American cardiovascular drug research trial, AVALON, to study the arterial elasticity impact of their combination drug, Caduet, a combination of Norvasc and Lipitor; and
• Solvay Pharmaceuticals, Inc. chose the CR-2000 Research System for a multi-site cardiovascular drug trial.
The inclusion of the CR-2000 Research System in these important pharmaceutical research trials provide credibility and promotes awareness of our blood pressure waveform analysis technology in the global medical marketplace.
The Practicing Physician Market
The CVProfilor® DO-2020 CardioVascular Profiling System is designed for use by physicians, other health care professionals and trained medical personnel. As of 2007, American Medical Association estimates indicate that there are more than 950,000 licensed physicians actively working in the U.S., about 350,000 of which are included in our target market as potential users of the CVProfilor® DO-2020 System as follows:
• Approximately 346,000 physicians specializing in internal medicine, general and family practice
physicians (that is, primary care physicians);
• Approximately 4,000 non-interventional cardiovascular disease specialists.
Our market focus is toward internists, primary care physicians and other health care providers who can use our product for the cardiovascular risk-stratification of their hypertensive and diabetic patients, and who are directly involved in screening patients for potential underlying vascular disease.
Marketing Strategy
Our primary objective is to establish the CardioVascular Profiling products as the standard for identifying and monitoring patients with cardiovascular disease.
HDI/PulseWave™ CR-2000 Research System
The CR-2000 Research System, originally launched during December of 1998 has been marketed worldwide through international distributors. In the U.S., the CR-2000 Research System is not recognized as a medical device and is marketed “for research purposes only”.
CVProfilor® DO-2020 System
On November 1, 2000, we obtained clearance from the FDA to market the CVProfilor® DO-2020 System in the U.S. for use by physicians and other health care providers to non-invasively screen patients for the presence of vascular disease. On March 16, 2001, we announced that a controlled launch of our FDA cleared CVProfilor® DO-2020 System was underway with the objective of validating pricing, marketing and reimbursement expectations within our U.S. target market of internal medicine, family practice and cardiology physicians prior to implementing a nationwide launch.
In the United States, the CVProfilor® DO-2020 System is being marketed to physicians under two pricing structures. Physicians may:
- purchase a new CVProfilor® DO-2020 System;
- purchase a refurbished CVProfilor® DO-2020 System;
The majority of our revenue is derived from sales of the CVProfilor® to physicians. We use a network of independent distributors and representatives who are not employees of the Company and who sell complementary medical devices to primary care physicians.
CVProfilor® MD-3000 System
Following the introduction of the CVProfilor® MD-3000 System in June 2002, we began introducing the product to our international distributors to market it to cardiovascular specialists, cardiologists and primary care physicians for use in screening, diagnosing and monitoring the treatment of patients with cardiovascular disease within international markets.
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The MD-3000 System is offered to distributors who re-sell it in their territory. Our distributors have the right to set the selling price of the MD-3000 System within their assigned territory. To date, there have been no commercial sales of the MD-3000 to physician or research customers.
Engineering
We provide ongoing technical support for our products. We contract with external hardware and software engineering firms for special projects in support of our products.
Production
We have been producing CR-2000 Research Systems within our manufacturing facility since November 1998 and DO-2020 Physician Systems since March 2001. The design, development and integration of all of the components necessary to fabricate and manufacture our products were undertaken on our behalf by a contract engineering firm. According to testing performed at TÜV Product Service, Inc., the CR-2000 Research System has been found to be in full compliance with all electromagnetic immunity and emissions requirements, and with the requirements for displaying the CE Mark. The CVProfilor® DO-2020 System was also evaluated by Underwriters Laboratories, Inc., and the System complies with the UL electrical safety standard.
Currently, we manufacture all versions of the CardioVascular Profiling System within our facility located in Eagan, Minnesota, using a complete quality system approach in compliance with the FDA’s Quality System Regulations (QSR), and international standards 93/42/EEC, Council Directive Concerning Medical Devices (MDD), and the Canadian Medical Device Regulations (CMDR) . Further, our manufacturing facility has been certified as being in compliance with the ISO-13485: 2003 standard by BSI Product Services. Despite having a small production staff, we believe that we can accommodate current requirements and should be able to meet anticipated future needs to manufacture, test, package, and ship all products within our in-house facility.
Competition
Competition in the medical device industry is intense and many of our competitors have substantially greater financial, manufacturing, marketing, distribution and technical resources than we do. We compete directly with manufacturers of standard blood pressure cuff devices (sphygmomanometers), as well as many established companies manufacturing more elaborate and complex medical instruments.
Government Regulation
Medical devices, such as our CVProfilor® DO-2020 System, are subject to strict regulation by state and federal authorities, including the Food and Drug Administration, or FDA, and comparable authorities in certain states. In addition, our sales and marketing practices are subject to regulation by the United States Department of Health and Human Services pursuant to federal anti-kickback laws, and are also subject to similar state laws.
Under the Federal Food, Drug and Cosmetic Act, or the FDCA, and its relevant amendments and acts (1976 Medical Device Amendments, 1990 Safe Medical Devices Act, 1992 Medical Device Amendments, 1997 FDA Modernization Act, and 2002 Medical Device User Fee and Modernization Act) and the regulations promulgated thereunder, manufacturers of medical devices are required to comply with rules and regulations concerning the design, testing, manufacturing, packaging, labeling and marketing of medical devices. Medical devices intended for human use are classified into three categories (Classes I, II and III), depending upon the degree of regulatory control to which they will be subject. Our products are considered Class II devices.
If a Class II device is substantially equivalent to an existing device that has been continuously marketed since the effective date of the 1976 Amendments, FDA requirements may be satisfied through a Premarket Notification Submission (510(k)) under which the applicant provides product information supporting its claim of substantial equivalence. In a 510(k) Submission, the FDA may also require that it be provided with clinical test results demonstrating the safety and efficacy of the device. The process of obtaining clearances or approvals from the FDA and other applicable regulatory authorities can be expensive, uncertain and time consuming, frequently requiring several years from the commencement of clinic trials or submission of data to regulatory acceptance. On November 1, 2000, our 510(k) submission was granted clearance by the FDA to market our CVProfilor® DO-2020 System. Our CR-2000 Research System is not marketed in the U.S. for the treatment of patients – it is marketed “for research purposes only” to clinical research investigators for the purpose of collecting data in cardiovascular studies.
As a manufacturer of a medical device, we are also subject to certain other FDA regulations, and our manufacturing processes and facilities are subject to continuing review by the FDA to ensure compliance with these regulations. We believe that our manufacturing and quality control procedures conform to the requirements of FDA regulations. FDA clearances and approvals often include significant limitations on the intended uses for which a product may be marketed. FDA enforcement policy strictly controls and prohibits the promotion of cleared or approved medical devices for non-approved or “off-label” uses. In addition, product clearances or approvals may be withdrawn for failure to comply with regulatory standards or the occurrence of unforeseen problems following initial marketing.
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Medical device laws are also in effect in many of the countries outside of the United States in which we do business. In June 1998, the European Union Medical Device Directive became effective. All medical devices must meet the Medical Device Directive standards and receive CE Mark certification to be sold in the European Union. CE Mark certification involves a comprehensive quality system audit and review of product data by the notified body in Europe. Both our CVProfilor® MD-3000 and our CR-2000 Research System have been through this assessment and bear the CE Mark. Other countries have similar requirements based on conformance to quality standards consistent with our ISO-13485 certification and/or the FDA’s Quality System Regulations.
Federal, state and foreign regulations regarding the manufacture and sale of healthcare products and medical devices are subject to future change. We cannot predict what material impact, if any, these changes might have on our business. Future changes in regulations or enforcement policies could impose more stringent requirements on us, compliance with which could adversely affect our business. These changes may relax certain requirements, which could prove beneficial to our competitors and thus adversely affect our business. In addition, regulations of the FDA and state, federal and foreign laws and regulations depend heavily on administrative interpretations, and we cannot assure that future interpretations made by the FDA, or other regulatory authorities, with possible retroactive effect, will not adversely affect us. In addition to the regulations directly pertaining to us and our products, many of our health care provider customers and potential customers are subject to extensive regulation and governmental oversight. Regulatory changes in the healthcare industry that adversely affect the business of our customers could have a material adverse effect on our business, financial condition and results of operations. Failure to comply with the FDA and any applicable regulatory requirements could result in, among other things, civil and criminal fines, product recalls, detentions, seizures, injunctions and criminal prosecutions. Further, we can give no assurance that we will be able to obtain additional necessary regulatory clearances or approvals in the U.S., or internationally, on a timely basis, if ever. Delays in the receipt of, or failure to receive, these clearances or 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.
Reimbursement
Physician reimbursement is an important aspect in the CVProfilor® DO-2020 System’s success. There is no assurance that adequate third party reimbursement for the CVProfilor® DO-2020 System will be sustainable at present, or in the future.
The Centers for Medicare & Medicaid Services, or CMS, a division of the U.S. Department of Health and Human Services, or HHS, has established three levels of coding for health care products and services as follows:
• Level I, Current Procedural Terminology, or CPT, codes for physicians’ services;
• Level II, National Codes for supplies and certain services; and
• Level III, local codes.
The coding system applicable to the CVProfilor® DO-2020 System is Level I. Insurers require physicians to report their services using the CPT coding system.
Having achieved FDA 510(k) clearance to market the CVProfilor® DO-2020 System, we are able to petition the American Medical Association, or AMA, for a recommendation on whether the CVProfilor® DO-2020 System fits within any existing CPT codes or whether it requires a new code application or code revision. In the event the AMA determines that none of the existing CPT codes are appropriate for the CVProfilor® DO-2020 System, we believe that it may take two or more years to obtain a CVProfilor® DO-2020 System technology-specific CPT code. During this time, physicians may be required to use a “miscellaneous” code for patient billing purposes, although the level of reimbursement they receive, if any, will depend on each individual payer’s assessment of the procedure. Our inability to obtain third party reimbursement and/or direct patient payment for the CVProfilor® DO-2020 System would have a material adverse effect on our business.
Many physicians using the CVProfilor® DO-2020 System are obtaining reimbursement today under an existing CPT code. The level of physician reimbursement varies considerably by provider, by patient and by clinic. Reimbursement will always vary considerably by the patient’s medical necessity, by physician, by provider, by geography and by provider coverage plans, making the process of obtaining reimbursement for the CVProfilor® DO-2020 by current physician customers an important component of our success in marketing our products.
Reimbursement is not a factor in the marketing of our HDI/PulseWave™ CR-2000 Research System as our sales of this product are to firms who do not use it in patient care. Rather, the CR-2000 Research System is purchased by entities that utilize it to measure changes in human research subjects and, therefore, typically fund the acquisition of our CR-2000 Research System as part of the total research study cost.
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Patents and Proprietary Technology
Our success depends, in part, on our ability to maintain patent protection for our products and processes, to preserve our trade secrets and to operate without infringing the property rights of others. We are the exclusive assignee of eleven issued U.S. patents, six of which expire on March 20, 2018, three of which expire on September 10, 2019, one of which expires on August 1, 2022 and one of which expired on October 23, 2010.
We also have obtained an exclusive license to utilize the intellectual property described within twelve U.S. patents from the Regents of the University of Minnesota. The requirement to pay a royalty under this license agreement for these patents expires concurrently with the expiration date of the last of these patents to expire, which was December 28, 2010. No further royalty payment is due to the University of Minnesota. The license agreement remains in effect, even though these patents have expired.
These 23 patents (11 exclusively assigned and 12 licensed from the University of Minnesota) relate to our blood pressure waveform analysis procedures, our cardiovascular profiling technology and/or the non-invasive determination of cardiac output. Included in these patents are six U.S. issued patents relating to the design, configuration and manufacturing of our Sensor, which is a key component of our products. The Sensor is manufactured for us by Apollo Research Corp., or Apollo.
We can give no assurance that our current patents and licenses will provide a competitive advantage, that the pending applications will result in patents being issued, or that our competitors will not design around any patents or licenses issued to us.
We intend to rely to the fullest extent possible on trade secrets, proprietary “know-how” and our ongoing endeavors involving product improvement and enhancement. We can give no assurance that nondisclosure agreements and invention assignment agreements, which we have or will execute, will protect our proprietary information and know-how or will provide adequate remedies in the event of unauthorized use or disclosure of that information, or those others will not be able to independently develop that information.
University of Minnesota Research and License Agreement
On September 23, 1988, we entered into a Research and License Agreement, or the License Agreement, with the University of Minnesota, or the University, pursuant to which the University granted to us an exclusive, worldwide license under the patents that relate to our products for diagnostic, therapeutic, monitoring and related uses. The License Agreement is subject to any rights retained by the U.S. government, pursuant to U.S. law and regulations, in the patents and licensed technologies in connection with any U.S. government funding of the University’s research of the license technology. The License Agreement expires with the last to expire of the patents related to the licensed technology (which expired on December 28, 2010). We also have the right to grant sub-licenses under the University’s patents.
In consideration of the License Agreement, we conducted expanded clinical trials of arterial compliance technology and are continuing to use our best efforts to develop commercial medical devices. Through December 31, 2010, we paid a royalty on revenue from commercialization of our products in the amount of three percent (3%) of gross revenue (less certain reductions).
Employees and Consultants
As of June 30, 2011, we employed 3 full-time employees, 1 full-time contract employee, and 1 part-time contract employee, none of whom are engaged in sales positions. We believe that our employee relations are good.
We currently engage consultants and independent contractors and have ongoing consultant relationships with several experts including: experts in quality systems, regulatory affairs and FDA matters and software and hardware engineering consultants.
We may retain additional consultants as necessary to accommodate our need for experts in selected areas of product-related endeavors and other business matters.
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ITEM 1A. RISK FACTORS
The following are important factors that could cause actual results to differ materially from those anticipated in any forward-looking statements made by or on behalf of the Company.
Risks Related to Our Business
We are presently generating minimal revenue. We cannot assure you that we will ever be able to generate significant revenue, attain or maintain profitable operations, or successfully implement our business plan or current development opportunities. As of June 30, 2011, we had an accumulated deficit of $28,018,054. Until we are able to generate significant revenue from our business activities, we expect to continue to incur operating losses and will need to find sources of significant, immediate additional capital to offset such losses to continue operations.
The likelihood of our success must be considered in view of the expenses, difficulties and delays we have encountered, and may encounter in the future. Our profitability is dependent on gaining market acceptance of our products, developing distribution channels, maintaining the capacity to manufacture and sell our products efficiently and successfully, and the continuation of third party reimbursement. We cannot assure you that we will successfully meet any or all of these goals.
We may need additional capital in the future to continue our business. Until such time as our products generate sufficient revenue to fund our operations, we will continue to require additional capital to continue our business, the receipt of which cannot be assured. We believe that we have sufficient capital derived from the proceeds of our prior securities offerings and cash flow from existing operations to meet our needs for the next 12 months after June 30, 2011. Our ability to execute our business strategy depends to a significant degree on our ability to obtain sufficient and timely future financing.
Our long-term capital needs are subject to our ability to raise additional capital and to generate adequate revenue from our products, neither of which can be assured. We may seek additional funds through an additional offering of our equity securities or by incurring indebtedness. We cannot assure you that any additional funds will be available or that sufficient funds will be available to us or that funds will be available in a timely way. Additional funds may not be available on terms acceptable to us or our security holders. Any future capital that is available may be raised on terms that are dilutive to our security holders.
Our success is mainly dependent upon a single product, the CVProfilor® DO-2020 System. We have developed a plan for the marketing of the CVProfilor® DO-2020 System and expect the CVProfilor® DO-2020 System to generate the majority of our revenue. However, we cannot assure you that our marketing plan will be successfully implemented or ultimately generate significant revenue, if any. To date, we have generated only minimal revenue from the CVProfilor® DO-2020 System. Further, even if we successfully market the product, we must be able to manufacture a reliable product and deliver that product to our distributor or customer in a timely fashion. Because we lack extensive manufacturing and marketing experience with this product, we cannot assure you that we will be successful in producing or marketing the CVProfilor® DO-2020 System. Sales of CVProfilor® DO-2020 Systems have taken more time and resources than originally anticipated due to delays in obtaining market acceptance, consistent and satisfactory levels of third party reimbursements for the CVProfilor® DO-2020 Systems and delays in integrating the CVProfilor® DO-2020 Systems into the clinic operations in which they are sold. Further, higher than expected manufacturing, marketing and distribution costs, lower than expected reimbursement levels, lower than expected usage by physicians, and/or other competitive forces may require us to alter our pricing or marketing structure in a manner that could have a material and adverse effect on us. Our ability to sell new customers on purchasing the system has been more challenging than originally anticipated.
The uncertainty of market acceptance of our product and/or the clinical application of the technology will affect our business. Our financial performance depends upon the extent to which our products are accepted by research investigators (regarding the CR-2000 Research System) as being useful, and by physicians and other health care providers as being effective, reliable and safe for use in screening patients for underlying vascular disease (regarding the CVProfilor® DO-2020 System) and for use in screening, diagnosing and monitoring the treatment of patients with vascular disease (regarding the CVProfilor® MD-3000 System). Third party reimbursement to physicians is a complex matter and varies region-by-region. If the CVProfilor® DO-2020 System fails to achieve market acceptance due to lack of appropriate third party reimbursement to physicians, the failure of arterial elasticity parameters to be perceived as reliable and clinically beneficial or any other factors which cause a lack of acceptance by physicians, we will likely be forced to cease operations.
We are unable to predict how our products will be accepted by the market, if at all, or if accepted, what the demand for them could be. Achieving market acceptance requires that we educate the marketplace about the anticipated benefits associated with the use of our products and also requires us to obtain and disseminate additional data acceptable to the medical community as evidence of our product’s clinical benefits. We cannot assure you that we will be successful in educating the marketplace about our products or that available data concerning these benefits will create a demand by the research or medical community for our products. We cannot assure you that our services will be profitable to, or become generally accepted by, physicians. To date, the rate of physician utilization has developed more slowly than we anticipated and is generally lower than we anticipated. In addition, our products are premised on the medical assumption that a loss of arterial elasticity is an indicator of the early onset of vascular disease. While we believe, based on many clinical research studies and trials, that the loss of arterial elasticity is indeed an indicator for the early onset of vascular disease, we cannot assure you that our claims will be fully accepted by the medical community, if at all.
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Our physician customers are dependent upon the availability of third party reimbursement to the physician and/or direct patient payment. Medicare and private health coverage insurers and other payer organizations may not provide or consistently provide reimbursement for our products. The availability of third party reimbursement for our medical products and services may affect the physician’s decision to use our products. As a result, our financial performance may be impacted by the availability of reimbursement, if any, for the cost of our products from government payers, private health coverage insurers and other payer organizations. Our experience has shown that reimbursement associated with the CVProfilor® DO-2020 System varies significantly by the patient’s medical necessity, by physician, by provider, by geography and by provider coverage plans. Not only must the procedure utilizing our products be recognized as a valid medical diagnostic procedure, the payer must offer coverage for the procedure. Further, even if the payer offers coverage, the amount of reimbursement will vary and may or may not be sufficient to cover the cost of the use of our product by the physician. Because of the complex interactions between these factors, consistent reimbursement for the costs associated with our product may not be available. Further, we cannot assure you that adequate third party reimbursement will be available for the CVProfilor® DO-2020 System. Our product user’s inability to obtain adequate third party reimbursement and/or direct patient payment for the CVProfilor® DO-2020 System would have a material adverse effect on our business, financial condition and results of operations.
We have not been successful in growing our sales force. The process of finding qualified sales reps who can convey the clinical and economic value proposition to prospective customers has proved difficult. Currently we do not have any dedicated sales reps directly employed by the Company. Instead, we have been using a network of independent distributors who sell several medical device products to sell the CVProfilor® DO-2020 System to physicians in the U.S. Our revenues are dependent upon growing the network of independent distributors. No assurances can be given that the Company will be successful in growing the network of independent distributors.
We operate in an intensely competitive market. Competition from medical devices, or other medical measures, that are used to screen patients for cardiovascular disease is intense and likely to increase. We compete with manufacturers of non-invasive blood pressure monitoring equipment and instruments. In addition, our products will also compete with traditional blood pressure testing by means of a standard sphygmomanometer, which is substantially less expensive than our products. Many of our competitors have substantially greater capital resources, name recognition, research and development experience, and more extensive regulatory, manufacturing and marketing capabilities than we do. Many of these competitors offer well-established, broad product lines and ancillary services that we do not offer. Some of our competitors have long-term or preferential supply arrangements with physicians, medical clinics, pharmaceutical firms, and hospitals which may act as a barrier to market entry for our products. In addition, other large health care companies or medical instrument firms may enter the non-invasive vascular screening market in the future. Competing companies may succeed in developing products that are more efficacious or less costly than any that we may produce, and these companies also may be more successful than we are in producing, marketing or obtaining third party reimbursement for their new or existing products. Competing companies may also introduce competitive pricing pressures that may adversely affect our sales levels and margins. As a result, we cannot assure you that we will be able to compete successfully with existing or new competitors.
We depend upon sub-assembly contract manufacturers. To date, we have relied on independent contractors for the fabrication of sub-assemblies and major product components used in the production of all our products. Our products must be manufactured in accordance with strict regulatory requirements. To date, our products have been manufactured in limited quantities and not on a large commercial scale. As a result, we cannot assure you that we will not encounter difficulties in obtaining reliable and affordable contract manufacturing assistance and/or in scaling up our manufacturing capabilities. This may include problems involving production yields, per-unit manufacturing costs, quality control, component supply and shortages of qualified manufacturing personnel. In addition, we cannot assure you that we will not encounter problems relating to integration of components if changes are made in the configuration of the present products. Any of these difficulties, as well as others related to these, could result in our inability to satisfy any customer demand for our products in a cost-effective and efficient manner and therefore would likely have a material adverse affect on our business, financial condition and results of operations.
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We depend upon a limited number of suppliers for several key components; failure to obtain certain key components could materially affect our business. By way of example, we currently obtain our Arterial PulseWave™ Sensor, or the Sensor (which is the subject of six of our U.S. issued patents) through a manufacturing services agreement with Apollo Research Corp., or Apollo, our sole supplier of this component. Apollo indicates that they can continue to meet our production needs for the Sensor in the near term. Additionally, we were advised by Omron Colin Medical Corp., our sole supplier of our M1000 Blood Pressure Monitor, that they would be unable to continue to supply us with our M1000 Blood Pressure Monitor. We currently have an inventory of such monitors, which we believe would be sufficient for at least two years of production. If we exhaust our inventory of the Sensor or the Blood Pressure Monitor for manufacture of our existing products and are not able to obtain supply of this component from an alternative supplier, or if we are not able to timely bring to market the new versions of our products utilizing the new monitor or Sensor before exhausting our inventory, we may be forced to suspend our manufacture of our products or delay or cancel shipments to customers which would have a material adverse effect upon our business. If the components are not available for our needs, our products may be unavailable to sell to customers, customers may lose confidence in our products and us, and we may need to make new regulatory applications to reflect changes in product manufacturing with a new component, if available. If we are unable to obtain an adequate supply of components meeting our standards of reliability, accuracy and performance, we would be materially adversely affected.
We lack significant sales and distribution channels. We commenced marketing of the HDI/PulseWave™ CR-2000 Research System in December 1998 and currently have not developed an international distribution network. We commenced marketing of the CVProfilor® DO-2020 System in March 2001 and have yet to generate any significant revenue based on placements of it or from unit sales. We have not yet developed a nationwide distribution network for our products. Currently, we do not have any dedicated sales reps directly employed by the Company. Even as we enter into agreements with distributors and/or independent representatives, we cannot assure you that the distributors or independent representatives will devote the resources necessary to provide effective sales and promotional support for our products. Our ability to expand product sales will largely depend on our ability to develop relationships with distributors or independent representatives who are willing to devote the resources necessary to provide effective sales and promotional support, and to educate, train and service both a sales force and the medical community in its entirety. We cannot assure you that we will be able to accomplish any or all of these objectives. We also cannot assure you that our financial condition will allow us to withstand sales cycles of the length that may be necessary to assure market acceptance for our CR-2000, DO-2020 or MD-3000 Systems.
Our financial results and the market price of our securities are subject to significant fluctuations, which may affect the price of our securities. Our quarterly results and the market price of our securities may be subject to significant fluctuations due to numerous factors, such as variations in our revenue, earnings and cash flow, the ability to meet market expectations, the availability of product components, market acceptance, changes in price, terms or product mix, changes in manufacturing costs or the introduction of new products by us or our competitors. Our inability to successfully market the CVProfilor® DO-2020 System will adversely affect our financial results which may have an adverse effect on the market price of our securities. We cannot assure you that we will ever generate significant revenue or that our revenue or net income will ever improve on a quarterly basis or that any improvements from quarter to quarter will be indicative of future performance. In addition, our expenses may not match revenue on a quarterly basis, and a delay in future revenue would adversely affect our operating results.
In addition, the stock markets are experiencing significant price and volume fluctuations. These market fluctuations may result in the market price of our common stock falling abruptly and significantly or remaining significantly depressed. Significant fluctuations in our stock price may adversely impact our ability to raise additional capital and adversely impact the exercise of warrants which is a potential source of additional capital for the Company.
If we do not adapt to technological change, our business will suffer. The medical device market is characterized by intensive development efforts and advancing technology. Our success will largely depend upon our ability to anticipate and keep pace with advancing technology and competitive innovations. We cannot assure you that we will be successful in identifying, developing and marketing new products or in enhancing our existing product. In addition, we cannot assure you that new products or alternative screening and diagnostic techniques will not be developed that will render our current or planned products obsolete or inferior. Rapid technological development by competitors may result in our products becoming obsolete.
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We are subject to product liability exposure and have limited insurance coverage. We face an inherent business risk of exposure to product liability claims in the event that the use of our products is alleged to have resulted in adverse clinical events. We have obtained a general liability insurance policy that covers potential product liability claims up to $1 million per incident and $2 million aggregate per year. We cannot assure you that liability claims will not be excluded from these policies, will not exceed the coverage limits of these policies, or that the insurance will continue to be available on commercially reasonable terms, or at all. Consequently, a product liability claim or other claim with respect to uninsured liabilities or in excess of insured liabilities would have a material adverse effect on our business, financial condition and results of operations.
Failure to effectively manage the growth of our business would have an adverse effect on our business. In an effort to curtail our expenses and conserve our working capital, we have reduced the number of our employees. The execution of our business plan will likely place increasing demands on our existing management and operations. We must successfully attract, train, motivate, manage and retain new employees and continue to improve our operational, financial and management information systems. We cannot assure you that we will be able to effectively manage any expansion of our business. Our inability to effectively manage our growth could have a material adverse effect on our business, financial condition and results of operations.
We depend upon key personnel and we must hire and retain qualified personnel to be successful. We are highly dependent on a limited number of key management personnel, particularly our Chief Executive Officer and Chairman, Mark N. Schwartz, and our President and Secretary, Greg H. Guettler. We do not have key-person life insurance on these key personnel. Our future success will depend on our ability to attract and retain highly qualified personnel. We cannot assure you that we will be successful in hiring or retaining qualified personnel. We also depend upon consultants for services related to important aspects of our business, such as marketing, regulatory compliance and payer reimbursement. We compete with other companies and organizations for the services of qualified consultants. The loss of key personnel or the availability of consultants, or an inability to hire or retain qualified personnel or consultants, could have a material adverse effect on our business, financial condition and results of operations.
We have a limited number of personnel and the loss of one or more of them may adversely affect our operations. We currently employ three full time employees, one full time contract employee and one part time contract employee and engage the services of several consultants. The loss of one or more of our employees could result in the interruption of our operations and adversely affect our financial condition and results. There is no assurance that we will be able to timely employ replacement personnel or engage the temporary services of consultants in the event that we suffer the loss of one or more of our employees.
If we are unable to protect our proprietary technology, our business will suffer. Our success depends, in part, on our ability to maintain patent protection for our products and processes, to preserve our trade secrets and to operate without infringing the property rights of others. We are the exclusive assignee of several issued U.S. patents, and we have obtained an exclusive license to utilize the intellectual property described within several other U.S. patents from the Regents of the University of Minnesota. Additionally, there are several issued patents which also describe technology involving our products and which may offer us some further protection. Several of the patents that relate to our blood pressure waveform analysis procedures, our cardiovascular profiling technology, and/or the non-invasive determination of cardiac output have expired.
The validity and breadth of claims coverage in medical technology patents involve complex legal and factual questions and, therefore, may be highly uncertain. We cannot assure you that our current patents and licenses will provide a competitive advantage, that the pending applications will result in patents being issued, or that our competitors will not design around any patents or licenses issued to us. In addition, we cannot assure you that any agreements with employees or consultants will protect our proprietary information and “know-how” or provide adequate remedies in the event of unauthorized use or disclosure of our information, or that others will not be able to develop this information independently. We cannot assure you that allegations of infringement of the proprietary rights of third parties will not be made, or that if made, the allegations will not be sustained if litigated. There has been substantial litigation regarding patent and other intellectual property rights in the medical device industry. Litigation may be necessary to enforce patents issued to us, to protect trade secrets or “know-how” we own, to defend us against claimed infringement of the rights of others or to determine the ownership, scope or validity of our proprietary rights and the rights of others. Any of these claims may require us to incur substantial litigation expenses and to divert substantial time and effort of management personnel. An adverse determination in litigation involving the proprietary rights of others could subject us to significant liabilities to third parties, could require us to seek licenses from third parties, and could prevent us from manufacturing, selling or using our products. The occurrence of this litigation or the effect of an adverse determination in any of this type of litigation could have a material adverse effect on our business, financial condition and results of operations.
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Risks Related to Government Regulation
Our business and our products are subject to extensive regulation by both U.S. and foreign governments. Our CVProfilor® DO-2020 System, which is classified as a medical device in the U.S., is subject to regulation by U.S. federal and state authorities and by foreign governments in the countries in which we sell this product. Further, our CVProfilor® MD-3000, the international version of our CVProfilor® DO-2020 intended for use by physicians outside of the U.S., is subject to regulation by the foreign governments in the countries in which we sell this product.
Regulation in the United States. Under various amendments to the Federal Food, Drug and Cosmetic Act, or the FDCA, and related regulations, manufacturers of medical devices are required to comply with very specific rules and regulations concerning the design, testing, manufacturing, packaging, labeling and marketing of medical devices. Failure to comply with the FDCA and any applicable regulatory requirements could result in, among other things, civil and criminal fines, product recalls, detentions, seizures, injunctions and criminal prosecutions.
Our CVProfilor® DO-2020 System was cleared for marketing in the U.S. by the Food and Drug Administration, or the FDA. FDA enforcement policy strictly prohibits the promotion of cleared or approved medical devices for non-approved or “off-label” uses. In addition, the FDA may withdraw product clearances if the CVProfilor® DO-2020 System fails to comply with regulatory standards or if we encounter unforeseen problems following initial marketing. In order to obtain FDA clearance for our product, the facilities and manner in which we operate and do business must adhere to a quality system and in this regard, we are presently ISO-13485:2003 registered. Failure to receive future necessary regulatory clearances or approvals or a lengthy approval process would have a material adverse effect on our business, financial condition and results of operations.
Our level of revenue and profitability as a medical device company may be affected by the efforts of government and third party payers to contain or reduce the costs of health care through various means. In the U.S., there have been, and we expect that there will continue to be, a number of federal, state and private proposals to control health care costs. Significant changes in the nation’s health care system could have a material adverse effect on our business, financial condition and results of operations.
Regulation by Foreign Governments. Our products are subject to regulations that vary from country to country. Although we believe that the CR-2000 and the MD-3000 products can be exported without us having obtained FDA clearance for the marketing of the products in the U.S., there is no assurance that the FDA may not take a contrary position, in which case we could not export our products without first obtaining FDA clearance of the products for marketing in the U.S., which would be an expensive and time consuming process. Export sales of our products may be subject to general U.S. export regulations.
We cannot assure you that foreign regulatory clearances or approvals will be granted on a timely basis, if ever, or that we will not be required to incur significant costs in obtaining or maintaining our foreign regulatory clearances or approvals. The process of obtaining foreign regulatory approvals in certain countries can be lengthy and require the expenditure of large resources. We cannot assure you that we will be able to meet export requirements or obtain necessary foreign regulatory approvals for our products on a timely basis or at all.
In order to obtain a CE Mark for our product (which is required to sell the product in the UK and the European Union), the facilities and manner in which we operate and do business must adhere to a quality system and in this regard, we are presently ISO-13485:2003 registered. Because both the HDI/PulseWave™ CR-2000 Research System and the CVProfilor® MD-3000 System display the CE Mark, they must conform to European Council Directive 93/42/EEC regarding Medical Devices.
Delays in receipt of or failure to receive foreign clearances or approvals, or failure to comply with existing or future regulatory requirements and quality system regulations, would have a material adverse effect on our business, financial condition and results of operations.
Changes in state and federal laws relating to confidentiality of patient medical records could limit our customers’ ability to use services associated with our product. The Health Insurance Portability and Accountability Act of 1996, or HIPAA, mandates the adoption of national standards for the transmission of certain types of medical information and the data elements used in such transmissions to insure the integrity and confidentiality of such information. We believe that our products are in compliance with the regulations under HIPAA and with the rules under HIPAA for electronic healthcare transmissions and code sets used in those transmissions. We may be required to incur additional expenses in order to comply with any amendments to these requirements. In addition, the success of our compliance efforts may also be dependent on the success of healthcare participants in complying with the standards.
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Future regulatory requirements may materially impact our business. Federal, state and foreign regulations regarding the manufacture and sale of healthcare products and diagnostic devices are subject to future change. We cannot predict what material impact, if any, these changes might have on our business. Future changes in regulations or enforcement policies could impose more stringent requirements on us, compliance with which could adversely affect our business. These changes may relax some requirements, which could prove beneficial to our competitors and thus adversely affect our business. In addition, regulations of the FDA and state and foreign laws and regulations depend heavily on administrative interpretations. We cannot assure you that future interpretations made by the FDA, or other regulatory authorities, with possible retroactive effect, will not adversely affect our business, financial condition and results of operations.
We cannot assure you that we will be able to obtain necessary regulatory clearances or approvals in the United States or internationally on a timely basis, if at all. Delays in the receipt of, or failure to receive, these clearances or 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.
Regulations extending to our contractors and customers affect the manufacture and sale of our products. We and the design and manufacturing vendors with whom we contract are subject to regulation by the FDA relating to the design and manufacture of the CVProfilor® DO-2020 System. This regulation includes, but is not limited to, required compliance with the FDA’s Quality System Regulation, or QSR, and equivalent state and foreign regulations. Our failure, or the failure of any of these vendors, to comply with applicable regulations may subject us or one or more of the vendors, or the medical device designed and produced for and by us, to regulatory action. A regulatory action could threaten or cut off our source of supply or cause the FDA to order the removal of the CVProfilor® DO-2020 System from the market. While we believe we could locate and qualify other sources to design or manufacture necessary components, supply interruptions in the meantime may have a materially adverse effect on our business, financial condition and results of operations. Regulatory changes in the healthcare industry that adversely affect the business of our customers could have a material adverse effect on our business, financial condition and results of operations.
Other Risks
Our ability to obtain additional financing requires approval of the Series A Preferred Stockholders. We issued shares of Series A Convertible Preferred Stock and common stock to a group of investors in the August 2003 and February 2004 Placements, in the aggregate. As a result of the voting rights inherent in the Series A Preferred Stock and common stock and certain provisions of the Shareholders’ Agreement, we may not enter into certain transactions without the consent of the holders of a majority of the Series A Preferred Stock purchased in these Placements. In addition, our Articles of Incorporation provide that our Board of Directors is divided into three classes, with each class elected in successive years for a term of three years. This provision of our Articles of Incorporation and the concentration of ownership following the Placement may have the effect of delaying or preventing a change in control of us or changes in our Board of Directors or management.
Our securities are illiquid and will be subject to rules relating to “penny stocks.” On March 17, 2003, we requested that our securities be withdrawn from The Nasdaq SmallCap Market. Since March, 2011, our securities have been quoted on the OTCQB, the middle tier of the OTC market under the symbol “HDII.PK” for our common stock. There can be no assurance that any market will continue to exist for our securities, or that our securities may be sold without a significant negative impact on the price per share.
Our securities are subject to the rules promulgated under the Securities Exchange Act of 1934 relating to “penny stocks.” These rules require brokers who sell securities that are subject to the rules, and who sell to other than established customers and institutional investors, to complete required documentation, make suitability inquiries of investors and provide investors with information concerning the risks of trading in the security. Consequently, an investor would likely find it more difficult to buy or sell our securities in the open market.
Our stock prices may be depressed and our shareholders may experience significant dilution upon the exercise of certain outstanding warrants, which may be affected by the actual or perceived 43,325,843 shares of our common stock issued and outstanding. Of these outstanding shares, all shares are either freely tradable or eligible for sale under either Rule 144 or Rule 144(k).
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As of September 15, 2011, we have a total of 26,851,550 shares of common stock, which may be issued upon exercise of various options or warrants.
As of September 15, 2011, we also have 7,336,680 shares of our common stock issuable upon conversion of our 611,390 outstanding shares of Series A Convertible Preferred Stock.
Moreover, we have registered all the shares of our common stock issuable through our 1995 Long-Term Incentive and Stock Option Plan and 750,000 shares of our common stock issuable through our 1998 Stock Option Plan. We have also registered 287,500 shares purchasable through the exercise of all other outstanding options and warrants.
At any time our common stock trades at prices in excess of the exercise or conversion price of the options or warrants, it is possible that the holders of those options or warrants may exercise their conversion or purchase privileges. If any of these events occur, the number of shares of our outstanding common stock could increase substantially. This increase, in turn, could dilute future earnings per share, if any, and could depress the market value of our common stock.
We cannot predict the extent to which the dilution, the availability of a large amount of shares for sale, and the possibility of additional issuances and sales of our common stock will negatively affect the trading price of our common stock or the liquidity of our common stock.
We do not intend to pay cash dividends on our common stock. We have never paid cash dividends on our common stock and do not anticipate paying any cash dividends on our common stock in the foreseeable future. We anticipate that profits, if any, received from operations will be devoted to our future operations.
We are subject to certain provisions, which could impede takeovers by third parties even if such a change of control might be beneficial to our shareholders. We have established three classes of directors with staggered terms of office, supermajority voting requirements for business combinations, and the right of the Board of Directors to issue, without shareholder approval, preferred stock on terms set by the Board. We are also subject to certain terms of Minnesota law that could have the effect of delaying, deterring or preventing a change of control, including Sections 302A.671 and 302A.673 of the Minnesota Business Corporation Act, which prohibits a Minnesota corporation from engaging in any business combination with any interested shareholder for a period of four years from the date when the person became an interested shareholder unless certain conditions are met.
Minnesota law and our Articles of Incorporation impose limitations on the liability of our directors to our shareholders. Our Articles of Incorporation provide, among other things, that directors, including a person deemed to be a director under applicable law, are not to be personally liable to us or our shareholders for monetary damages for breach of fiduciary duty as a director, except to the extent provided by applicable law (i) for any breach of the director's duty of loyalty to us or our shareholders, (ii) for acts or omissions, not in good faith or that involve intentional misconduct or a knowing violation of law, (iii) under Sections 302A.559 or 80A.23 of the Minnesota Business Corporation Act, as amended, (iv) for any transaction from which the director derived an improper personal benefit, or (v) for any act or omission occurring prior to the date that the applicable articles became effective. Our Articles further provide that if the Minnesota Business Corporation Act hereafter is amended to authorize the further elimination or limitation of the liability of directors, then the liability of our directors will be eliminated or limited to the fullest extent permitted by the Minnesota Business Corporation Act, as so amended.
ITEM 2. Properties
On October 24, 1997, we entered into a non-cancelable operating lease agreement for approximately 6,900 square feet of commercial office and light assembly space at The Waters Business Park in Eagan, Minnesota. Effective September 8, 2010, the term of this operating lease was extended for forty-eight (48) months from November 1, 2010 to October 31, 2014. The monthly gross rent, including basic operating expenses, is approximately $6,000.
ITEM 3. Legal Proceedings
Although we have been involved in various legal actions in the ordinary course of our business, currently we are not aware of any pending legal proceedings against or involving us.
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PART II
ITEM 5. Market for Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Since March, 2011, our common stock have been quoted on the OTCQB, the middle tier of the over-the-counter market under the symbol “HDII.PK” for our common stock. Previously our shares were quoted on the NASDAQ SmallCap Market under the symbol “HDII.OB”.. As of September 15, 2011, there were: (i) 151 shareholders of record of our common stock, without giving effect to determining the number of shareholders who hold shares in “street name” or other nominee status; (ii) 89 holders of our Series A Convertible Preferred Stock, which is convertible into 7,336,680 shares of our common stock; and (iii) 43,325,843 outstanding shares of our common stock, of which all shares are either freely tradable or eligible for sale under Rule 144 or Rule 144(k).
The following table sets forth, for the fiscal quarters indicated, the high and low closing prices of our common stock as reported by the OTCQB or the Over-the-Counter Bulletin Board, as applicable. These quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission, and may not represent actual transactions.
Stock Price | ||||||||
High | Low | |||||||
Fiscal 2011 | ||||||||
First Quarter | $ | 0.09 | $ | 0.09 | ||||
Second Quarter | 0.12 | 0.07 | ||||||
Third Quarter | 0.09 | 0.09 | ||||||
Fourth Quarter | 0.06 | 0.04 | ||||||
Fiscal 2010 | ||||||||
First Quarter | $ | 0.17 | $ | 0.03 | ||||
Second Quarter | 0.19 | 0.05 | ||||||
Third Quarter | 0.23 | 0.15 | ||||||
Fourth Quarter | 0.18 | 0.11 |
Dividend Policy
We have never paid cash dividends and have no plans to do so in the foreseeable future. Our future dividend policy will be determined by our Board of Directors and will depend upon a number of factors, including our financial condition and performance, our cash needs and expansion plans, income tax consequences, and the restrictions that applicable laws and our credit arrangements then impose.
Recent Sales of Unregistered Securities
Option Grants
During the fiscal year ended June 30, 2011, we granted options to purchase shares of common stock to our directors and employees, pursuant to our various Stock Plans.
ITEM 6. Selected Financial Data
As a smaller reporting company, we are not required to provide the information required by this item.
ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations Overview We are engaged in the design, development, manufacture and marketing of proprietary medical devices that we believe non-invasively detect subtle changes in the elasticity of both large and small arteries. We are currently marketing three products: the HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System, the CVProfilor® DO-2020 CardioVascular Profiling System and the CVProfilor® MD-3000 CardioVascular Profiling System.
§ The CR-2000 Research System is being marketed worldwide “for research purposes only” to clinical research investigators for the purpose of collecting data in cardiovascular and pharmaceutical studies.
§ In the U.S., the CVProfilor® DO-2020 System is being marketed to primary care physicians and other health care professionals as a capital sale item .
§ The CVProfilor® MD-3000 System is being marketed through distributors to physicians outside the United States. To date, there have been no commercial sales of the MD-3000 to physician or research customers.
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Critical Accounting Policies
The financial statements are prepared in accordance with accounting principles generally accepted in the U.S., which requires us to make estimates and assumptions in certain circumstances that affect amounts reported in the accompanying financial statements and related footnotes. In preparing these financial statements, management has made its best estimates and judgments of certain amounts included in the financial statements, giving due consideration to materiality. We do not believe there is a great likelihood that materially different amounts would be reported related to the accounting policies described below. However, application of these accounting policies involves the exercise of judgment and use of assumptions as to future uncertainties and, as a result, actual results could differ from these estimates.
Revenue Recognition. We recognize revenue in accordance with U.S. Securities and Exchange Commission’s Staff Accounting Bulletin (SAB) No. 104, “Revenue Recognition.” Pursuant to SAB No. 104, the Company recognizes revenue from the sale of equipment at the time of shipment to a customer or distributor. Shipment occurs only after receipt of a valid purchase order. Payments from customers and distributors are either made in advance of shipment or within a short time frame after shipment. In the case of sales to distributors, such payment is not contingent upon resale of the product to end users. Shipping and handling costs are billed in addition to the equipment sales. At the time of shipment, all of the criteria for revenue recognition set forth in SAB No. 104 have been met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the selling price is fixed or determinable and collectability is reasonably assured.
Equipment rental revenue, whether from a minimum monthly fee or from a per-patient-tested fee, is recognized when all of the criteria for recognition set forth in SAB No. 104 have been met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the selling price is fixed or determinable and collectability is reasonably assured.
In the case of either a sale or rental of our product, there are no post-shipment obligations except for warranty maintenance contracts, which affect the timing of revenue recognition. Neither customers nor distributors have a right to return or exchange our product. Warranty repairs on all of the above are handled on a repair or replacement basis, at our discretion. Further, there is no installation of our product; it is ready to use when plugged into an electrical outlet and no specialized knowledge is required to ready it for use. For these reasons, we have concluded that our revenue recognition policy is appropriate and in accordance with SAB No. 104.
Allowance for Doubtful Accounts. Accounts receivable are reviewed to determine the need for an allowance for amounts that may become uncollectible in the future. The necessity of an allowance is based on management’s review of accounts receivable balances and historic write-offs.
Inventories and Related Allowance for Excess and Obsolete Inventory. Inventories are valued at the lower of cost or market and reviewed to determine the need for an allowance for excess and obsolete inventories. The need for an allowance is based on management’s review of inventories on hand compared to estimated future usage and sales.
Research and Development. Research and development are expensed as incurred.
Deferred Revenue. The Company has warranty maintenance contracts with its customers ranging from 1 to 5 years to provide replacement parts to its customers. The Company requires full payment in advance and these payments are recorded as deferred revenue. The Company recognizes the deferred revenue on a quarterly basis.
Income Taxes. Income taxes are provided for using the liability method of accounting. A deferred tax asset or liability is recorded for all temporary differences between financial and tax reporting. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax basis. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effect of changes in tax laws and rates on the date of enactment.
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The Company accounts for income taxes pursuant to Financial Accounting Standards Board guidance. This guidance prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than not to be sustained upon examination by taxing authorities. The Company believes its income tax filing positions and deductions will be sustained upon examination and, accordingly, no reserves, or related accruals for interest and penalties have been recorded at June 30, 2011 and 2010. In accordance with the guidance, the Company has adopted a policy under which, if required to be recognized in the future, interest and penalties related to the underpayment of income taxes will be classified in operating expenses in the statements of operations. The Company has three open years of tax returns subject to examination.
Stock-Based Compensation. The Company regularly grants options to individuals under various plans. Compensation costs relating to share-based payment transactions, including grants of employee and director stock options, are recognized in the financial statements. That cost will be measured based on the fair value of the equity or liability instrument issued. The Company is required to measure the cost of employee services received in exchange for stock options based on the grant-date fair value of the award, and to recognize the cost over the period the employee is required to provide services for the award. The fair value of options granted during fiscal year 2011 was estimated using the Black-Scholes option pricing model.
Fiscal | Risk-Free | Expected Dividend | Expected | Expected | ||||
Year Ended | Interest Rate | Yield | Life | Volatility | ||||
June 30, 2011 | 3.18% | None | 10 years | 250.86% | ||||
June 30, 2010 | 2.97% | None | 10 years | 161.76% |
1,350,000 stock options were granted during fiscal year 2011. Dividend yield and expected volatility are estimated using historical amounts that are anticipated to be consistent with current values. Expected life of each option is based on the life of the option agreements. Risk-free interest rate is determined using the U.S. treasury rate.
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Results of Operations
As of June 30, 2011, we had an accumulated deficit of $28,018,054. Until we are able to generate significant revenue from our activities, we expect to continue to incur operating losses. As of June 30, 2011, we had cash and cash equivalents of $753,881. We believe that our capital resources will allow us to remain in business for at least the next twelve months following June 30, 2011.
Fiscal Year Ended June 30, 2011 Compared to Fiscal Year Ended June 30, 2010
The following is a summary of our Revenue and Cost of Sales for the fiscal years ended June 30, 2011 and 2010, respectively:
Fiscal Year Ended June 30, 2011 | ||||||||
Equipment | Equipment | Service/ | ||||||
Total | Sales | Rental | Contract | |||||
Revenue | $ 1,389,181 | $ 1,137,300 | $ 48,144 | $ 203,737 | ||||
Cost of Sales | 275,848 | 232,893 | 4,506 | 38,449 | ||||
Gross Profit | $ 1,113,333 | $ 904,407 | $ 43,638 | $ 165,288 | ||||
Gross Profit % | 80.14% | 79.52% | 90.64% | 81.13% | ||||
Fiscal Year Ended June 30, 2010 | ||||||||
Equipment | Equipment | Service/ | ||||||
Total | Sales | Rental | Contract | |||||
Revenue | $ 1,383,669 | $ 1,187,272 | $ 75,820 | $ 120,577 | ||||
Cost of Sales | (19,935) | (26,312) | - | 6,377 | ||||
Gross Profit | $ 1,403,604 | $ 1,213,584 | $ 75,820 | $ 114,200 | ||||
Gross Profit % | 101.44% | 102.22% | 100.00% | 94.71% |
Total Equipment Sales Revenue for the fiscal year ended June 30, 2011 was $1,137,300, compared to $1,187,272 for the fiscal year ended June 30, 2010, a 4.2% decrease.
For the fiscal year ended June 30, 2011, we recognized revenue for the CVProfilor® DO-2020 System “per-patient-tested” rental program of $48,144, compared to $75,820 for the fiscal year ended June 30, 2010, a 36.5% decrease. We have a handful of legacy rental customers and have encouraged them to purchase their CVProfilor® DO-2020 System. We do not use the rental model any longer.
For the fiscal year ended June 30, 2011, Service/Contract income was $203,737, compared to $120,577 for the fiscal year ended June 30, 2010, a 68.9% increase. This increase was a result of an increase in warranty maintenance agreements sold and software upgrades sold primarily in the fourth quarter.
As of June 30, 2010, the Company realized that the Inventory obsolescence reserve established in 2003 was not reflective of the current business sales volume and changed its methodology in estimating this reserve. The Company wanted to be able to better reflect the gross profit on equipment sales. A more appropriate approach was to look at surplus parts components beyond the number of units the Company could sell based on quantities of critical parts. This change, at June 30, 2010, resulted in the Inventory obsolescence reserve account to decrease by $150,614, causing an increase in net inventory and a decrease in cost of sales for the fiscal year. For the year ended June 30, 2011, the surplus parts approach is reflected in the numbers below:
Fiscal Year Ended June 30 | |||||||
2011 | 2010 | ||||||
Cost of Sales, excluding changes in inventory obsolescence reserve………………………………………………… | $ 246,424 | $ 214,215 | |||||
Increase (decrease) in inventory Obsolescence Reserve.. …………………………………………… | 29,424 | (234,150) | |||||
Cost of Sales, as reported ……………………………………………………. | $ 275,848 | $ (19,935) |
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Total selling, general and administrative expenses for the fiscal year ended June 30, 2011 were $717,586 compared to $2,402,773 for the fiscal year ended June 30, 2010, a 70.1% decrease. The following is a summary of the major categories included in selling, general and administrative expenses:
Fiscal Year Ended June 30 | Change from Prior Year | ||||||
2011 | 2010 | Dollar | Percent | ||||
Wages, related expenses and benefits………………………………. | $ 437,444 | $ 483,460 | $ (46,016) | -9.52% | |||
Deferred Compensation………………………………… | (718,684) | 1,135,249 | (1,853,933) | 163.31% | |||
Patents and related expenses…...…………………………………… | 4,210 | 2,875 | 1,335 | 46.43% | |||
Outside consultants………………………………………………….. | 185,904 | 72,506 | 113,398 | 156.40% | |||
Rent (building/equipment) and utilities………………………………… | 54,433 | 53,697 | 736 | 1.37% | |||
Insurance-general and directors/officers liability………………….. | 22,583 | 20,840 | 1,743 | 8.36% | |||
Selling, marketing and promotion…………………….. | 434,625 | 390,790 | 43,835 | 11.22% | |||
Legal and audit/accounting fees………………………………… | 63,879 | 45,274 | 18,605 | 41.09% | |||
Depreciation and amortization……………………………………… | 2,526 | 2,391 | 135 | 5.65% | |||
Stock option expense……………………………………………………. | 129,869 | 106,250 | 23,619 | 22.23% | |||
Other-general and administrative…………………………………. | 100,797 | 89,441 | 11,356 | 12.70% | |||
Total selling, general and administrative expenses……….. | $ 717,586 | $ 2,402,773 | $ (1,685,187) | -70.14% |
Because the Company’s stock price decreased during the twelve month period ended June 30, 2011, deferred compensation expense decreased by $1,853,9334 over the prior year. Outside consultants expenses increased 156.4% due to the use of contract labor for customer service, accounting and IT systems consulting. Legal expenses increased 41% from 2010 to 2011 as the company had additional securities related legal issues in 2011 than in 2010. Selling, marketing and promotion expenses increased by $43,835 because of increase distributor commissions.
As previously mentioned, outside consultants expense increased to $185,904 for the fiscal year ended June 30, 2011 from $72,506 for the fiscal year ended June 30, 2010, a 156.4% increase. A breakdown of outside consultant expense for fiscal years 2011 and 2010 is provided below:
Fiscal Year Ended June 30 | Change from Prior Year | |||||||||||||||
2011 | 2010 | Dollar | Percent | |||||||||||||
Outside Consultants Expense | ||||||||||||||||
SOX/404 Consulting | $ | 14,385 | $ | 3,300 | $ | 11,085 | 335.9 | % | ||||||||
R&D Engineering - Consulting | 1,377 | 10,695 | (9,318 | ) | -87.1 | % | ||||||||||
IT Systems Consulting | 28,331 | 6,443 | 21,888 | 339.7 | % | |||||||||||
Quality Systems & Regulatory | 44,575 | 30,944 | 13,631 | 44.05 | % | |||||||||||
Web Site Consulting | 120 | 80 | 40 | 50.0 | % | |||||||||||
Other Contract Accounting & Customer Service | 97,116 | 21,044 | 76,072 | 361.5 | % | |||||||||||
Total Outside Consultants Expense | $ | 185,904 | $ | 72,506 | $ | 113,398 | 156.4 | % |
Other Contractor expenses increased $76,072 from 2010 to 2011 due to the use of contractors instead of employees in accounting and customer service functions during 2011. The decrease in R&D Consulting expenses of 87.1% from 2010 to 2011 is tied to the development of next generation of the Company’s technology that was developed to test a new sensor technology, which was in the early stages of research and development during 2010. Limited investment was made on this in 2011. The increase in quality System/Regulatory consulting expense is primarily a result of losing our quality manager and shifting that work to an outside consultant.
Other – general and administrative expenses increased to $100,797 for the fiscal year ended June 30, 2011 from $89,441 for the fiscal year ended June 30, 2010, respectively, a 12.7% increase. A breakdown of Other – general and administrative expense for fiscal years 2011 and 2010 is provided below.
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Fiscal Year Ended June 30 | Change from Prior Year | |||||||||||||||
Other general and administrative expenses: | 2011 | 2010 | Dollar | Percent | ||||||||||||
Stock Transfer Agent/Registrar Fees | $ | 4,709 | $ | 4,174 | $ | 535 | 12.8 | % | ||||||||
Telephone | 9,937 | 10,343 | (406 | ) | -3.9 | % | ||||||||||
Postage/Delivery/Courier | 8,835 | 2,432 | 6,403 | 263.3 | % | |||||||||||
Licenses & Fees | 3,080 | 4,197 | (1,117 | ) | -26.6 | % | ||||||||||
SEC Filings Expense | 4,180 | 4,848 | (668 | ) | -13.8 | % | ||||||||||
Office Supplies | 3,714 | 5,106 | (1,392 | ) | -27.3 | % | ||||||||||
State Income Taxes | 1,383 | 1,600 | (217 | ) | -13.5 | % | ||||||||||
Payroll Expense - (Paychex) | 1,754 | 2,743 | (989 | ) | -36.0 | % | ||||||||||
Trash Removal | 768 | 1,089 | (321 | ) | -29.5 | % | ||||||||||
Repairs & Maintenance | 6,669 | 7,266 | (597 | ) | -8.2 | % | ||||||||||
Computer Software/Supplies | 1,016 | 1,888 | (872 | ) | -46.2 | % | ||||||||||
Bank Charges - Credit Cards | 15,930 | 9,878 | 6,052 | 61.3 | % | |||||||||||
Meals & Entertainment | 1,364 | 2,793 | (1,429 | ) | -51.2 | % | ||||||||||
Auto Expense/Parking | 4,006 | 4,943 | (937 | ) | -18.9 | % | ||||||||||
Warehouse Supplies | 621 | 703 | (82 | ) | -11.6 | % | ||||||||||
Travel - Other | 12,159 | 21,673 | (9,514 | ) | -43.9 | % | ||||||||||
Meetings | 0 | (1,353 | ) | 1,353 | 100.0 | % | ||||||||||
Patent Expense | 4,210 | 2,875 | 1,335 | 46.4 | % | |||||||||||
All other components | 16,462 | 2,243 | 14,219 | 633.9 | % | |||||||||||
Total Other-general & administrative | $ | 100,797 | $ | 89,441 | $ | 11,356 | 12.7 | % |
Net income for the fiscal year ended June 30, 2011 was $406,312 compared to a net loss of $989,759 for the fiscal year ended June 30, 2010. For the fiscal year ended June 30, 2011, basic and diluted net loss per share was $0.01 based on weighted average shares outstanding of 42,646,016 and 49,982,696. For the fiscal year ended June 30, 2010, basic and diluted net loss per share was $(.02), based on weighted average shares outstanding of 41,278,165.
Liquidity and Capital Resources
Cash and cash equivalents had a net decrease of $299,767 and a net increase of $355,730 for the years ended June 30, 2011 and June 30, 2010, respectively. The significant elements of these changes were as follows:
Fiscal Year Ended June 30 | ||||||||
Net cash provided by / (used in) operating activities: | 2011 | 2010 | ||||||
— Net income (loss), as adjusted for non-cash items (expenses associated with deferred stock based compensation, depreciation, stock option expense, and inventory obsolescence reserve adjustment) | $ | ( 125,619 | ) | $ | 64,018 | |||
— (Increase) / Decrease in accounts receivable: | (A) 33,768 | (A) 4,427 | ||||||
– (A) Collection of funds prior to shipment directly affects the decrease in accounts receivable | ||||||||
— (Increase) / Decrease in inventory: | (B) 29,606 | (B) 71,018 | ||||||
– (B) We sell mostly reconditioned units, and only replenish inventory for items that are needed to build new units. | ||||||||
— Increase / (Decrease) in accrued vacation, payroll and payroll taxes – (C)Expense amounts that relate to the amount of accrued vacation, accrued payroll, and accrued payroll taxes | (C) (31,116) | (C) 34,790 | ||||||
— Increase / (Decrease) in deferred revenue: – (D) Cash received from warranty maintenance contracts, and is amortized over the length of the contract. | (D) (53,932) | (D) 62,143 | ||||||
— Increase/(Decrease) in accrued commissions: – (E) Expense amounts related to accrued commissions | (E) (64,000) | (E) 110,500 |
23
In fiscal year 2011, for investing activities, The Company loaned $125,000 to a Minot, North Dakota real estate company associated with one of our directors. The Company had no investing activities for the years ended June 30, 2010.
In fiscal year 2011, for financing activities, the Company raised $30,000 through the exercise of warrants. In fiscal year 2010, the Company raised $75,000 through the exercise of warrants held by investors and $1,650 through the exercise of options held by employees.
We have incurred operating losses and have not generated significant cash flow from operations. As of June 30, 2011, we had an accumulated deficit of $28,018,054.
As of June 30, 2011, we had cash and cash equivalents of $753,881 and anticipate that these funds, will allow us to continue our business for at least the next twelve months following June 30, 2011.
Our current marketing strategy focuses on selling the CVProfilor® DO-2020 System to physicians who treat patients with hypertension and diabetes through our independent distributor network. We believe these physicians have the greatest interest in, and use for, our product. The most critical factor in our ability to increase revenue rests in our ability to expand our network of independent distributors selling the CVProfilor® DO-2020 System.
The Company is also exploring the possibility of selling certain assets of the CVProfilor business and licensing its proprietary technology.
No assurance can be given that additional working capital will be obtained in a timely manner or on terms and conditions acceptable to us or our shareholders. Our financing needs are based upon management estimates as to future revenue and expense. Our business plan and our financing needs are also subject to change based upon, among other factors, market conditions, and our ability to materially increase revenues. Should we conclude additional capital is required, efforts to raise additional funds may be hampered by the fact that our securities are quoted on the OTCQB, are illiquid and are subject to the rules relating to penny stocks.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements.
24
ITEM 8. Financial Statements and Supplementary Data
Financial Statements
Hypertension Diagnostics, Inc.
Years Ended June 30, 2011 and 2010
Contents
Report of Independent Registered Public Accounting Firm 26
Audited Financial Statements:
Balance Sheets 27
Statements of Operations 28
Statements of Shareholders’ Equity (Deficit) 29
Statements of Cash Flows 30
Notes to Financial Statements 31
25
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Audit Committee, Shareholders and Board of Directors of
Hypertension Diagnostics, Inc.
We have audited the accompanying balance sheets of Hypertension Diagnostics, Inc. (the “Company”) as of June 30, 2011 and 2010 and the related statements of operations, shareholders’ equity (deficit) and cash flows for the years then ended. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of its internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Hypertension Diagnostics, Inc as of June 30, 2011 and 2010, and the results of its operations and its cash flows for the years then ended, in conformity with U.S. generally accepted accounting principles.
/s/ Moquist Thorvilson Kaufmann Kennedy & Pieper LLC
Edina, Minnesota
September 15, 2011
26
Hypertension Diagnostics, Inc.
Balance Sheets
June 30, | |||||
Assets | 2011 | 2010 | |||
Current Assets: | |||||
Cash and cash equivalents | $ 753,881 | $ 1,053,648 | |||
Accounts receivable, net | 4,305 | 38,073 | |||
Inventory, net | 364,952 | 442,005 | |||
Prepaids and other current assets | 14,505 | 4,986 | |||
Note receivable-related party | 125,000 | - | |||
Total Current Assets | 1,262,643 | 1,538,712 | |||
Property and Equipment: | |||||
Leasehold improvements | 17,202 | 17,202 | |||
Furniture and equipment | 172,052 | 172,052 | |||
Computer & electronic equipment | 598,347 | 580,324 | |||
Equipment rental units | 162,351 | 162,351 | |||
Total Property and Equipment | 949,952 | 931,929 | |||
Less accumulated depreciation and amortization | (933,117) | (930,591) | |||
Property and Equipment, net | 16,835 | 1,338 | |||
Other Assets | 6,530 | 6,530 | |||
Total Assets | $ 1,286,008 | $ 1,546,580 | |||
Liabilities and Shareholders' Equity (Deficit) | |||||
Current Liabilities: | |||||
Accounts payable | $ 20,746 | $ 14,090 | |||
Accrued vacation, payroll and payroll taxes | 51,253 | 82,369 | |||
Accrued commissions | 46,500 | 110,500 | |||
Deferred revenue | 42,390 | 72,202 | |||
Deposits from customers | 970 | 970 | |||
Other accrued expenses | 35,857 | 26,468 | |||
Deferred compensation | 622,500 | 1,316,250 | |||
Total Current Liabilities | 820,216 | 1,622,849 | |||
Long Term Liabilities: | |||||
Deferred revenue, less current portion | 46,429 | 70,549 | |||
Shareholders' Equity (Deficit) | |||||
Series A Convertible Preferred Stock, $.01 par value: | |||||
Authorized shares--5,000,000 | |||||
Issued and outstanding shares—611,390 and 710,993 | |||||
at June 30, 2011 and 2010, respectively. Each share of | |||||
preferred stock is convertible into 12 shares of common | |||||
stock at the option of the holder. (Aggregate | |||||
liquidation preference of $8,444,722 and $8,419,333 | |||||
at June 30, 2011 and 2010, respectively.) | 6,114 | 7,110 | |||
Common Stock, $.01 par value: | |||||
Authorized shares--150,000,000 | |||||
Issued and outstanding shares-- 43,325,843 and 41,916,320 | |||||
at June 30, 2011 and 2010, respectively. | 433,258 | 419,163 | |||
Additional paid-in capital | 27,998,045 | 27,851,275 | |||
Accumulated deficit | (28,018,054) | (28,424,366) | |||
Total Shareholders' Equity (Deficit) | 419,363 | (146,818) | |||
Total Liabilities and Shareholders' Equity (Deficit) | $ 1,286,008 | $ 1,546,580 | |||
See accompanying notes. |
27
Hypertension Diagnostics, Inc.
Statements of Operations
Years Ended June 30, | ||||||||
2011 | 2010 | |||||||
Revenue: | ||||||||
Equipment sales | $ | 1,137,300 | $ | 1,187,272 | ||||
Equipment rental | 48,144 | 75,820 | ||||||
Service/contract income | 203,737 | 120,577 | ||||||
1,389,181 | 1,383,669 | |||||||
Cost of Sales: | ||||||||
Cost of sales | 246,424 | 214,215 | ||||||
Inventory obsolescence reserve | 29,424 | (234,150 | ) | |||||
Net Cost of Sales | 275,848 | (19,935 | ) | |||||
Gross Profit | 1,113,333 | 1,403,604 | ||||||
Expenses: | ||||||||
Selling, general and administrative | 717,586 | 2,402,773 | ||||||
Total Expenses | 717,586 | 2,402,773 | ||||||
Operating (income) loss | 395,747 | (999,169 | ) | |||||
Other Income: | ||||||||
Interest income | 8,033 | 9,410 | ||||||
Other income | 2,532 | - | ||||||
Total Other Income | 10,565 | 9,410 | ||||||
Net income (loss) before income taxes | 406,312 | (989,759 | ) | |||||
Income taxes | - | - | ||||||
Net income (loss) | $ | 406,312 | $ | (989,759 | ) | |||
Net Income (Loss) per Common Share: | ||||||||
Basic | $ | 0.01 | $ | (0.02 | ) | |||
Diluted | $ | 0.01 | $ | (0.02 | ) | |||
Weighted Average Common Shares Outstanding: | ||||||||
Basic | 42,646,016 | 41,278,165 | ||||||
Diluted | 49,982,696 | 41,278,165 | ||||||
See accompanying notes. | ||||||||
28
Hypertension Diagnostics, Inc.
Statements of Shareholders’ Equity (Deficit)
Additional | ||||||||||||||||||||
Preferred | Common Stock | Paid-in | Accumulated | |||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||
Balance at June 30, 2009…………. | 744,536 | $ | 7,445 | 40,963,088 | $ | 409,631 | $ | 27,677,572 | $ | (27,434,607 | ) | $ | 660,041 | |||||||
Conversion of Preferred Stock | ||||||||||||||||||||
into Common Stock …………… | (52,743 | (527 | 632,916 | 6,329 | (5,802 | ) | - | |||||||||||||
Warrants Exercised………………. | 19,200 | 192 | 305,316 | 3,053 | 71,755 | 75,000 | ||||||||||||||
Stock Options Exercised………… | 15,000 | 150 | 1,500 | 1,650 | ||||||||||||||||
Stock based compensation……... | 106,250 | 106,250 | ||||||||||||||||||
Net loss…………………………….. | (989,759 | ) | (989,759 | ) | ||||||||||||||||
Balance at June 30, 2010…………. | 710,993 | 7,110 | 41,916,320 | 419,163 | 27,851,275 | (28,424,366 | ) | (146,818 | ) | |||||||||||
Conversion of Preferred Stock | ||||||||||||||||||||
into Common Stock …………… | (107,283 | (1,073 | 1,287,396 | 12,874 | (11,801 | ) | - | |||||||||||||
Warrants Exercised………………. | 7,680 | 77 | 122,127 | 1,221 | 28,702 | 30,000 | ||||||||||||||
Stock based compensation……... | 129,869 | 129,869 | ||||||||||||||||||
Net income…...…………………. | 406,312 | 406,312 | ||||||||||||||||||
Balance at June 30, 2011…………. | 611,390 | $ | 6,114 | 43,325,843 | $ | 433,258 | $ | 27,998,045 | $ | (28,018,054 | ) | $ | 419,363 | |||||||
See accompanying notes. |
29
Hypertension Diagnostics, Inc.
Statements of Cash Flows
Years Ended June 30, | ||||||||
2011 | 2010 | |||||||
Operating Activities: | ||||||||
Net income (loss) | $ | 406,312 | $ | (989,759 | ) | |||
Adjustments to reconcile net loss to net | ||||||||
cash used in operating activities: | ||||||||
Deferred stock based compensation (income) expense | (693,750 | ) | 1,095,750 | |||||
Depreciation | 2,526 | 2,391 | ||||||
Stock option based compensation | 129,869 | 106,250 | ||||||
Inventory obsolescence reserve | 29,424 | (234,150 | ) | |||||
Change in operating assets and liabilities: | ||||||||
Accounts receivable | 33,768 | 4,427 | ||||||
Inventory | 29,606 | 71,018 | ||||||
Prepaids and other current assets | (9,519 | ) | (1,749 | ) | ||||
Accounts payable | 6,656 | (2,253 | ) | |||||
Accrued vacation, payroll and payroll taxes | (31,116 | ) | 34,790 | |||||
Accrued commissions | (64,000 | ) | 110,500 | |||||
Deferred revenue | (53,932 | ) | 62,143 | |||||
Other accrued expenses | 9,389 | 19,722 | ||||||
Net cash provided by(used in) operating activities | (204,767 | ) | 279,080 | |||||
Investing Activities | ||||||||
Issuance of note receivable-related party | (125,000 | ) | - | |||||
Financing Activities | ||||||||
Proceeds from exercise of warrants | 30,000 | 75,000 | ||||||
Proceeds from exercise of stock options | - | 1,650 | ||||||
Net cash provided by financing activities | 30,000 | 76,650 | ||||||
Net increase/(decrease) in cash and cash equivalents | (299,767 | ) | 355,730 | |||||
Cash and cash equivalents at beginning of period | 1,053,648 | 697,918 | ||||||
Cash and cash equivalents at end of period | $ | 753,881 | $ | 1,053,648 | ||||
Non Cash Investing Activities | ||||||||
Inventory transfer to equipment | $ | (18,023 | ) | $ | - | |||
See accompanying notes. |
30
Hypertension Diagnostics, Inc.
Notes to Financial Statements
Years Ended June 30, 2011 and 2010
1. Organization and Significant Accounting Policies
Description of Business
Hypertension Diagnostics, Inc. (the “Company”) was formed on July 19, 1988 to develop, design and market a cardiovascular profiling system. The Company does not review financial information in a disaggregated manner, and as a result the Company does not report separate segments.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.
Cash Equivalents
The Company considers all highly liquid investments with an original maturity of three months or less at the time of purchase to be cash equivalents. The Company maintains cash in financial institutions. The balances, at times, may exceed federally insured limits.
Accounts Receivable
The Company reviews customers’ credit history before extending unsecured credit. Accounts receivable are reviewed to determine the need for an allowance for amounts that may become uncollectible in the future. The necessity of an allowance is based on management’s review of accounts receivable balances and historic write-offs. Invoice terms can vary from at date of shipment to net 30 days. The Company does not accrue interest on past due accounts receivable. The Company writes off receivables when they are deemed uncollectible after all collection attempts have failed. The Company has determined that an allowance for doubtful accounts is not necessary as of June 30, 2011 and 2010.
Inventory
Inventories are valued at the lower of cost (first-in, first-out method) or market and principally consist of raw materials. Market value encompasses consideration of all business factors including price, contract terms and usefulness. The Company reviews inventory on a regular basis and provides for slow-moving, obsolete or unusable inventories by reducing inventory to its estimated useful or scrap value. A reserve for potential obsolescence was $207,756 and $178,330 at June 30, 2011 and 2010, respectively.
Property and Equipment
Property and equipment are stated at cost. Improvements are capitalized, while repair and maintenance costs are charged to operations when incurred. Depreciation is computed principally using the straight-line method. Estimated useful lives for leasehold improvements are the shorter of the lease term or estimated useful life and 5-7 years for furniture and equipment, computer and electronic equipment and equipment rental units.
Fair Value of Financial Instruments
The Company’s financial instruments are recorded on its balance sheet. The carrying amounts for cash, accounts receivable, note receivable,accounts payable, and accrued expenses approximate fair value due to the immediate or short-term maturity of these financial instruments.
Impairment of Long-Lived Assets
The Company will record impairment losses on long-lived assets used in operations when indicators of impairment are present and the undiscounted future cash flows estimated to be generated by those assets are less than the assets’ carrying amount. To date, no such losses have been recognized.
31
1. Organization and Significant Accounting Policies (continued)
Shipping and Handling Costs
The Company records all amounts billed to customers in a sales transaction related to shipping and handling as sales. The Company records costs related to shipping and handling in cost of sales.
Legal Costs
The Company expenses legal costs related to lawsuits as incurred.
Revenue Recognition
Equipment sales revenue is recognized at the time of shipment to a customer or distributor. Shipment occurs only after receipt of a valid purchase order. Payments from customers and distributors are either received in advance of shipment or within a short time frame after shipment. In the case of sales to distributors, such payment is not contingent upon resale of the product to end users. Shipping and handling costs are included as cost of equipment sales. At the time of shipment, all of the criteria for revenue recognition have been met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the selling price is fixed or determinable and collectability is reasonably assured.
Equipment rental revenue, whether from a minimum monthly fee or from a per-patient-tested fee, is recognized when all of the criteria for revenue recognition have been met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the selling price is fixed or determinable and collectability is reasonably assured.
In the case of either a sale or rental of the Company’s product, there are no post-shipment obligations except for warranty maintenance contracts, which affect the timing of revenue recognition. Neither customers nor distributors have a right to return or exchange product. Warranty repairs on all of the above are handled on a repair or replacement basis, at the Company’s discretion. Further, there is no installation of the product; it is ready to use when plugged into an electrical outlet and no specialized knowledge is required to ready it for use. For these reasons, the Company believes its revenue recognition policy is appropriate.
The Company has warranty maintenance contracts with its customers ranging from 1 to 5 years to provide replacement parts to its customers. These contracts are considered multiple element arrangements when initially sold with the related equipment. When a sale involves multiple elements, revenue is allocated to each respective element based on its estimated fair value. The Company requires full payment in advance and then a portion of the unearned amount is recorded as deferred revenue. The Company recognizes the deferred revenue on a quarterly basis over the maintenance contracts requisite service period. The Company recognizes as current portion deferred revenue the amount that it will recognize over the next 12 months. The remaining amount of deferred revenue is recognized as long-term deferred revenue.
Research and Development Costs
All research and development costs are charged to expense as incurred. The Company incurred $5,646 and $10,695 in research and development costs for the fiscal years ended June 30, 2011, and 2010, respectively.
Income Taxes
The Company accounts for income taxes by following an asset and liability approach to financial accounting and reporting for income taxes. Accordingly, deferred tax assets and liabilities arise from the difference between the tax basis of an asset or liability and its reported amount in the financial statements. Deferred tax amounts are determined using the tax rates expected to be in effect when the taxes will actually be paid or refunds received, as provided under currently enacted tax law. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Income tax expense or benefit is the tax payable or refundable, respectively, for the period plus or minus the change in deferred tax assets and liabilities during the period. In accordance with the guidance, the Company has adopted a policy under which, if required to be recognized in the future, interest related to the underpayment of income taxes will be classified as a component of interest expense and any related penalties will be classified in operating expenses in the statement of operations. The Company has three open years of tax returns subject to examination.
32
1. Organization and Significant Accounting Policies (continued)
The Company recognizes a financial statement benefit of a tax position only after determining that the relevant tax authority would more-likely-than-not sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the consolidated financial statements is the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement with the relevant tax authority.
Net Income (Loss) Per Share
Basic net income (loss) per share is computed using the weighted average number of common shares outstanding during each period. Diluted net income (loss) per share includes the dilutive effect of common shares potentially issuable upon the exercise of stock options, warrants, or the conversion of preferred stock. However, since the Company reported a loss for the year ended June 30, 2010, all potential common shares have been excluded from the calculation of diluted net loss per share, as the effect would have been anti-dilutive.
Stock-Based Compensation
The Company regularly grants options to individuals under various plans. The Company measures and recognizes compensation expense for all stock-based payment awards made to employees and directors on a straight-line basis over the respective vesting period of the awards. The compensation expense for the Company's stock-based payments is based on estimated fair values determined at the time of the grant of the portion of stock-based payment awards that are ultimately expected to vest.
The Company estimates the fair value of stock-based payment awards on the date of grant using the Black-Scholes option pricing model. This option pricing model involves a number of assumptions, including the expected term of the stock options, the volatility of the public market price for the Company's common stock and interest rates.
Recent Accounting Pronouncements
In January 2010, the FASB issued Improving Disclosures About Fair Value Measurements, which requires reporting entities to make new disclosures about recurring or nonrecurring fair-value measurements including significant transfers into and out of Level 1 and Level 2 fair-value measurements and information on purchases, sales, issuances, and settlements on a gross basis in the reconciliation of Level 3 fair-value measurements. This guidance is effective for annual reporting periods beginning after December 15, 2009, except for Level 3 reconciliation disclosures which are effective for annual periods beginning after December 15, 2010. The Company does not expect the adoption of this guidance to have a material impact on its financial statements.
2. Inventory
In evaluating its inventory as of June 30, 2010, the Company realized that the inventory obsolescence reserve methodology established in 2003 was inconsistent with the Company’s revenue model, which had shifted from almost, exclusively, rental to almost exclusively sale of capital equipment. The Company determined a more appropriate method for estimating the value of its inventory was to look at surplus parts components beyond the number of units the Company estimates it can sell based on quantities of critical parts. The change in estimate, at June 30, 2010, resulted in the inventory obsolescence reserve account to decrease by $150,614, causing an increase in net inventory and a decrease in cost of sales for the fiscal year.
Each quarter, the Company will review its inventory and supplier status to determine if further adjustments to the inventory obsolescence reserve are needed.
33
2. Inventory (continued)
At June 30, 2011 and 2010 inventory consisted of the following:
June 30 | |||||||
2011 | 2010 | ||||||
Raw materials……..……………………………………….. | $ 572,706 | $ 617,932 | |||||
Finished goods……………………………………………. | - | 2,403 | |||||
Inventory obsolescence reserve | (207,754) | (178,330) | |||||
Total Inventory……………………………………………. | $ 364,952 | $ 442,005 |
3. | Note Receivable – related party |
On May 3, 2011, the Company entered into a promissory note agreement with Minot 123, LLC, a North Dakota limited liability company (“Minot”), under which the Company loaned Minot $125,000 toward the purchase of an office building located at 123 1st Street, Minot, North Dakota (the “M Building”). At the time the agreement was entered into, Kenneth W. Brimmer a member of the company’s board of directors, was one of the three principals of Minot.
Minot acquired the M Building for an aggregate purchase price of $400,000 comprised of $200,000 in cash and $200,000 obtained through a seller-financed secured loan and associated first mortgage on the M Building.
Under the terms of the promissory note agreement (“Note”), Minot was required to use its best efforts to make M Building operational and rentable, as determined by the board of the Company, by the end of 45 calendar days from the date of the Note. If the M Building was not operational and rentable within 45 calendar days, then Minot could be required by the Company to repay the Note 90 days from the date of such determination with an interest rate of 8%.
Under the May 3, 2011 Agreement, to the extent that the Company determined that M Building was operational and rentable, then the Note would be forgiven and the Company, through a stock purchase, would acquire 100% of Minot from its current shareholders. The Company has elected to exercise its option to receive repayment of the note, a $20,000 payment was received on July 13, 2011, under an agreement with Minot, six monthly payments of $12,500 are due beginning on August 15, 2011 with the final payment including interest and reimbursement of legal fees is due and payable February 15, 2012. The obligation to repay the Note is secured by a second mortgage on M Building, second only to the first mortgage held by the seller of M Building to Minot. Mr. Brimmer is no longer affiliated with Minot.
4. Deferred Compensation Expense
The Company has entered into a Deferred Equity Compensation Agreement with its CEO, Mark N. Schwartz (the “Agreement”), whereby the Company will grant 225,000 phantom shares of its common stock to its CEO for every month of employment for the period January 1, 2010 through December 31, 2011. Prior to January 1, 2010, the Company granted 175,000 phantom shares of its common stock to its CEO for every month of employment. A cash payment will be made to the CEO equal to the price per share of the Company’s common stock times the number of phantom shares accrued at the earliest of certain Event Dates (as defined in the Agreement), which are noted below.
The Company has accrued a total deferred compensation liability of $622,500 at June 30, 2011 which is the fair market value of 12,450,000 phantom shares granted as of June 30, 2011, pursuant to the Agreement. Due to the changes in the closing price of the Company’s common stock during the year (a decrease from $0.135 to $0.050 per share), and the additional 2,700,000 phantom shares issued for the year, the Company recorded a net compensation benefit of $693,750 for the year ended June 30, 2011. For the year ended June, 30, 2010, the Company recorded a net compensation expense of $1,095,750. An increase in the Company’s common stock price would cause an increase in the deferred compensation, while a decrease in the Company’s stock price would cause a decrease in the deferred compensation liability.
34
4. Deferred Compensation Expense (continued)
Per the terms of the employment agreement, payment of the deferred compensation benefit will occur upon one of the following events: i) execution of a definitive agreement resulting in a change of control of the Company’s common stock; ii) termination of employment; iii) death of the CEO; or iv) no later than January 1, 2012. Upon one of these events, a cash payment over 24 months will be made to the CEO equal to the trading price per share of the Company’s common stock times the number of phantom stock shares accrued to date.
5. Income Taxes
Reconciliation of the statutory federal income tax rate to the Company’s effective tax rate is as follows:
2011 | 2010 | |
Federal tax at statutory rate | (34.0)% | (34.0)% |
State income taxes | (2.4) | (6.0) |
Change in valuation allowance | 36.4 | 40.0 |
Effective income tax rate | — % | — % |
At June 30, 2011, the Company has estimated net operating loss carryforwards totaling approximately $20,831,000 for federal income tax purposes and $15,793,116 for state income tax purposes. Loss carryforwards have begun to expire this fiscal year and will continue to expire through 2030.
No benefit has been recorded for such carryforwards due to continued operating losses, and utilization in future years may be limited under Section 382 of the Internal Revenue Code if significant ownership changes have occurred.
Components of deferred tax assets are as follows:
June 30 | |||||||
2011 | 2010 | ||||||
Loss carryforwards……………………………………….. | $8,020,000 | $7,869,000 | |||||
Inventory reserve ………………………………………… | 76,000 | 71,000 | |||||
Deferred compensation ………………………………….. | 234,000 | 528,000 | |||||
Accrued vacation…………………………………………. | 2,000 | 12,000 | |||||
Less valuation allowance………………………………… | (8,332,000) | (8,480,000) | |||||
Net deferred tax assets………………………………….. | $ - | $ - |
At June 30, 2011, the Company has no uncertain tax positions or associated interest and penalties. The Company does not expect any significant increases or decreases to its unrecognized tax positions within twelve months of this reporting date.
The Company is subject to U.S. Federal and Minnesota state income tax. However, to the extent allowed by law, the tax authorities may have the right to examine prior periods where net operating losses or tax credits were generated and carried forward, and make adjustments up to the amount of the net operating loss or credit carryforward amount.
35
6. Shareholders’ Equity
Description of Series A Preferred Stock
On August 28, 2003, the Company designated 4,177,275 shares of the Company’s 5,000,000 authorized shares of preferred stock as Series A Convertible Preferred Stock (the “Series A Preferred Stock”) pursuant to a Certificate of Designation, Preferences and Rights with respect to the Series A Preferred Stock (the “Certificate of Designation”). Each share of the Series A Preferred Stock is initially convertible into twelve (12) shares of the Company’s common stock, subject to adjustment as provided in the Certificate of Designation for customary anti-dilution adjustments and issuances below the conversion price in effect, initially ranging from $0.14 to $0.22 per share from three issuances ranging from an original purchase price of $1.68 to $2.64 . The Series A Preferred Stock is convertible into shares of the Company’s common stock at any time. Further, the Series A Preferred Stock will automatically be converted into the Company’s common stock upon sale of all or substantially all of the Company’s
assets, a consolidation or merger. Each share of the Series A Preferred Stock shall entitle its holder to vote on all matters voted on by holders of the Company’s common stock on an as-if converted basis. With each share of preferred stock issued in each of the three tranches, the holder was granted a warrant, exercisable into Series A Preferred Stock at $2.04, $2.64, and $3.60 per share, respectively.
In addition, so long as any shares of the Series A Preferred Stock are outstanding, the Company may not, without the approval of the majority of the holders of the Series A Preferred Stock then outstanding, take certain corporate actions, as described in the Certificate of Designation. Upon any liquidation, the holders of the Series A Preferred Stock are entitled to receive out of the Company’s assets a liquidation preference equal to an internal rate
of return on the adjusted stated value of the Series A Preferred Stock (currently $1.68 per share) equal to 20%. Any assets remaining after this initial distribution shall be distributed to the holders of the Company’s common stock and the Series A Preferred Stock on an as-if converted basis. As of June 30, 2011 and 2010, the value of this liquidation preference was $8,444,722 and $8,419,333, respectively.
Conversion of Preferred Stock into Common Stock
During the fiscal years ended June 30, 2011 and 2010, certain holders of the Company’s Series A Convertible Preferred Stock elected to convert their shares into shares of the Company’s common stock at a conversion rate of twelve (12) shares of common stock for each share of Series A Convertible Preferred Stock. An aggregate of 107,283 shares of Series A Convertible Preferred Stock were converted into an aggregate of 1,287,396 shares of common stock for the fiscal year ended June 30, 2011 and an aggregate of 52,743 shares of Series A Convertible Preferred Stock were converted into an aggregate of 632,916 shares of common stock for the fiscal year ended June 30, 2010.
Series A Preferred Stock and Common Stock Warrants
The following is a summary of the outstanding stock purchase warrants that were issued in connection with our private placements of Series A Preferred and Common Stock in August 2003 and February 2004 as of June 30, 2011:
36
6. Shareholders’ Equity (continued)
Warrant A | Warrant B | Warrant C | ||||||||||||||||||||||
Preferred | Common | Preferred | Common | Preferred | Common | |||||||||||||||||||
$ | 2.04 | $ | .17 | $ | 2.64 | (1) | $ | .22 | (2) | $ | 3.60 | $ | .30 | |||||||||||
August 2003 Placement | ||||||||||||||||||||||||
Outstanding Balance, June 30, 2009 | - | - | 89,810 | 1,428,171 | 410,198 | 6,523,233 | ||||||||||||||||||
Exercised during fiscal 2010 | - | - | 19,200 | 305,316 | - | - | ||||||||||||||||||
Expired during fiscal 2010 | - | - | - | - | - | - | ||||||||||||||||||
Outstanding Balance, June 30, 2010 | - | - | 70,610 | 1,122,855 | 410,198 | 6,523,233 | ||||||||||||||||||
Exercised during fiscal 2011 | - | - | 7,680 | 122,127 | - | - | ||||||||||||||||||
Expired during fiscal 2011 | - | - | - | - | - | - | ||||||||||||||||||
Outstanding Balance, June 30, 2011 | - | - | 62,930 | 1,000,728 | 410,198 | 6,523,233 | ||||||||||||||||||
Expiration Date | - | - | 09/30/12 | 09/30/12 | 09/30/12 | 09/30/12 | ||||||||||||||||||
February 2004 Placement | ||||||||||||||||||||||||
Outstanding Balance, June 30, 2009 | - | - | 94,496 | 1,502,702 | 82,686 | 1,314,868 | ||||||||||||||||||
Exercised during fiscal 2010 | - | - | - | - | - | - | ||||||||||||||||||
Expired during fiscal 2010 | - | - | - | - | - | - | ||||||||||||||||||
Outstanding Balance, June 30, 2010 | - | - | 94,496 | 1,502,702 | 82,686 | 1,314,868 | ||||||||||||||||||
Exercised during fiscal 2011 | - | - | - | - | ||||||||||||||||||||
Expired during fiscal 2011 | - | - | - | - | - | - | ||||||||||||||||||
Outstanding Balance, June 30, 2011 | - | - | 94,496 | 1,502,702 | 82,686 | 1,314,868 | ||||||||||||||||||
Expiration Date | - | - | 09/30/12 | 09/30/12 | 09/30/12 | 09/30/12 | ||||||||||||||||||
1) In February, 2010, the Company temporarily modified the exercise price on all of the Preferred Stock Warrant B from $2.64 to $1.68 to encourage the exercise of the warrants; at this time, the temporary price reduction is still in effect.
(2) In February, 2010, the Company temporarily modified the exercise price on all of the Common Stock Warrant B from $0.22 to $0.14 to encourage the exercise of the warrants; at this time, the temporary price reduction is still in effect.
In July 2011, the Company extended the above warrants through September 30, 2012 to encourage exercising of these warrants in order for the Company to receive additional funding. No compensation was recorded for this extension due to the warrants were originally connected to a capital raise. During the year ended June 30, 2011, the Company received $30,000 in cash proceeds for the exercise of common and preferred stock warrants of 7,680 and 122,127, respectively.
7. Stock Options
During 1995, the Company adopted the Hypertension Diagnostics, Inc. 1995 Long-Term Incentive and Stock Option Plan (the “1995 Option Plan”) that includes both incentive stock options and nonqualified stock options to be granted to employees, directors, officers, consultants and advisors of the Company. The maximum number of shares reserved under the Plan is 400,000 shares. The Board of Directors establishes the terms and conditions of all stock option grants, subject to the 1995 Option Plan and applicable provisions of the Internal Revenue Code. Incentive stock options must be granted at an exercise price not less than the fair market value of the common stock on the grant date. The options granted to participants owning more than 10% of the Company’s outstanding voting common stock must be granted at an exercise price not less than 110% of fair market value of the common stock on the grant date. The options expire on the date determined by the Board of Directors but may not extend more than ten years from the grant date while incentive stock options granted to participants owning more than 10% of the Company’s outstanding voting stock expire five years from the grant date. At September 22, 2005, the 1995 Option Plan terminated, at which time there were 2,500 shares available for grant. The outstanding options have a weighted average remaining contractual life of 3.46 years.
37
7.Stock Options (continued)
On May 1, 1998, the Board of Directors approved the 1998 Stock Option Plan (the “1998 Option Plan”), under which stock options may be granted to employees, consultants and independent directors of the Company, up to a maximum of 750,000 shares. Stock options may be either qualified or nonqualified for income tax purposes. On December 10, 2001, shareholders of the Company approved an amendment to the Company’s 1998 Option Plan to increase the number of shares reserved under the 1998 Option Plan from 750,000 to 1,250,000. Terms of the 1998 Option Plan are similar to the 1995 Option Plan above. The 1998 Option Plan expired in May 2008. At June 30, 2011, there were 669,572 options outstanding having exercise prices between $0.165 and $4.02 that had been granted under the 1998 Option Plan. The outstanding options had a weighted average remaining contractual life of 2.07 years.
On October 31, 2003, the Board of Directors approved the 2003 Stock Plan (the “2003 Option Plan”), under which stock options, stock appreciation rights, restricted stock and deferred stock may be granted to employees, consultants and independent directors of the Company. On November 10, 2005, the Board of Directors approved the following amendments to the 2003 Option Plan: 1) changed the definition of the term “Stock” to exclude Series A Convertible Preferred Stock; 2) changed the Shares Reserved for Issuance to exclude six million (6,000,000) shares of Series A Convertible Preferred Stock; and 3) eliminated the annual automatic grant of stock options to non-employee directors. Stock options granted may be either qualified or nonqualified for income tax purposes. Up to a maximum of 4,000,000 shares of common stock may be issued under the 2003 Option Plan. Terms of the 2003 Option Plan are similar to the 1995 Option Plan above. At June 30, 2011, there were 3,843,342 options outstanding having exercise prices between $0.11 and $0.20 that had been granted under the 2003 Option Plan. The outstanding options had a weighted average remaining contractual life of 4.16years.
On November 10, 2005, the Board of Directors approved the 2005 Stock Plan (the “2005 Option Plan”), under which stock options, stock appreciation rights, restricted stock and deferred stock may be granted to employees, consultants and independent directors of the Company. Stock options granted will be nonqualified for income tax purposes. Up to a maximum of 6,000,000 shares of common stock may be issued under the 2005 Option Plan. The options granted to participants owning more than 10% of the Company’s outstanding voting stock must be granted at an exercise price not less than 110% of the fair market value of the common stock on the grant date. The options expire on the date determined by the Board of Directors but may not extend more than ten years from the grant date. At June 30, 2011, there were 3,580,000 options outstanding having exercise prices between $0.09 and $0.16 that had been granted under the 2005 Option Plan. The outstanding options had a weighted average remaining contractual life of 7.28 years.
A summary of the outstanding options under all the stock option plans is as follows:
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7. Stock Options (continued)
Shares Available for Grant | Options Outstanding and Exercisable | Weighted Average Exercise Price per Share | Aggregate Intrinsic Value | |||||||||||||
1995 Option Plan | ||||||||||||||||
Balance at June 30, 2009 | - | 263,000 | $ | 0.17 | ||||||||||||
Exercised | - | - | - | |||||||||||||
Canceled/forfeited | - | (3,000 | ) | - | ||||||||||||
Balance at June 30, 2010 | - | 260,000 | 0.17 | |||||||||||||
Exercised | - | - | - | |||||||||||||
Canceled/forfeited | - | - | - | |||||||||||||
Balance at June 30, 2011 | - | 260,000 | $ | 0.17 | $ | - | ||||||||||
Remaining Contractual Life | 3.46 years | |||||||||||||||
1998 Option Plan | ||||||||||||||||
Balance at June 30, 2009 | - | 854,000 | $ | 1.08 | ||||||||||||
Exercised | - | - | - | |||||||||||||
Canceled/forfeited | - | (70,428 | ) | 2.47 | ||||||||||||
Balance at June 30, 2010 | - | 783,572 | 0.95 | |||||||||||||
Exercised | - | - | - | |||||||||||||
Canceled/forfeited | - | (114,000 | ) | 4.63 | ||||||||||||
Balance at June 30, 2011 | - | 669,572 | $ | 0.33 | $ | - | ||||||||||
Remaining Contractual Life | 2.07 years | |||||||||||||||
2003 Option Plan | ||||||||||||||||
Balance at June 30, 2009 | 961,658 | 3,038,342 | $ | 0.19 | ||||||||||||
Granted | (900,000 | ) | 900,000 | 0.11 | ||||||||||||
Exercised | - | (15,000 | ) | 0.11 | ||||||||||||
Canceled/forfeited | 30,000 | (30,000 | ) | 0.20 | ||||||||||||
Balance at June 30, 2010 | 91,658 | 3,893,342 | 0.17 | |||||||||||||
Granted | - | - | - | |||||||||||||
Exercised | - | - | - | |||||||||||||
Canceled/forfeited | 50,000 | (50,000 | ) | 0.15 | ||||||||||||
Balance at June 30, 2011 | 141,658 | 3,843,342 | $ | 0.17 | $ | - | ||||||||||
Remaining Contractual Life | 4.16 years | |||||||||||||||
2005 Option Plan | ||||||||||||||||
Balance at June 30, 2009 | 4,170,000 | 1,830,000 | $ | 0.16 | ||||||||||||
Granted | (400,000 | ) | 400,000 | 0.11 | ||||||||||||
Exercised | - | - | - | |||||||||||||
Canceled/forfeited | - | - | - | |||||||||||||
Balance at June 30, 2010 | 3,770,000 | 2,230,000 | 0.15 | |||||||||||||
Granted | (1,350,000 | ) | 1,350,000 | 0.10 | ||||||||||||
Exercised | - | - | - | |||||||||||||
Canceled/forfeited | - | - | - | |||||||||||||
Balance at June 30, 2011 | 2,420,000 | 3,580,000 | $ | 0.13 | $ | - | ||||||||||
Remaining Contractual Life | 7.28 years |
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7. Stock Options (continued)
The fair value of options granted during fiscal years 2011 and 2010 were estimated using the Black-Scholes option pricing model.
Risk-Free | Expected Dividend | Expected | Expected | |||||||
Fiscal Year Ended | Interest Rate | Yield | Life | Volatility | ||||||
June 30, 2010 | 2.97 | % | None | 10 years | 161.76 | |||||
June 30, 2011 | 3.18 | % | None | 10 years | 250.86 |
On December 17, 2010, the Company granted a total of 1,350,000 new stock options; 900,000 from the 2005 Plan were granted to the four independent board members for their 2011 board service at an exercise price of $0.10 per share, 400,000 from the 2005 Plan were granted to the Company’s President vesting over a two year period at an exercise price of $0.10 per share, and 50,000 from the 2005 Plan were granted to the Company’s Accounting Manager. at an exercise price of $0.09 per share.
Dividend yield and expected volatility are estimated using historical amounts that are anticipated to be consistent with current values. Expected life of option is based on the life of the option agreements. Risk-free interest rate is determined using the U.S. treasury rate.
As of June 30, 2011 and 2010, the Company recognized $129,869 and $106,250 of stock option expense. As of June 30, 2011, there was $87,125 of total unrecognized compensation costs related to the outstanding stock options, which is expected to be recognized over a weighted average period of 0.55 years.
8. Earnings (Loss) Per Share
The following table provides a reconciliation of the numerators and denominators used in calculating basic and diluted earnings per share for the years ended June 30, 2011 and 2010:
2011 | 2010 | |||||||
Basic earnings (loss) per share calculation: | ||||||||
Net income (loss) to common shareholders | $ | 406,312 | $ | (989,759 | ) | |||
Weighted average of common shares outstanding | 42,646,016 | 41,278,165 | ||||||
Basic net earnings (loss) per share | $ | 0.01 | $ | (0.02 | ) | |||
Diluted earnings (loss) per share calculation: | ||||||||
Net income (loss) to common shareholders | $ | 406,312 | $ | (989,759 | ) | |||
Weighted average of common shares outstanding | 42,646,016 | 41,278,165 | ||||||
Series A Convertible Preferred Stock (1) | 7,336,680 | - | ||||||
Stock Options (2) | - | - | ||||||
Warrants (3) | - | - | ||||||
Diluted weighted average common shares outstanding | 49,982,696 | 41,278,165 | ||||||
Diluted net income (loss) per share | $ | 0.01 | $ | (0.02 | ) |
(1) | At June 30, 2011, there 611,390 shares of Series A Convertible Preferred Stock outstanding and 710,933 at June 30, 2010. Using the preferred stock conversion ratio of 12:1, the common stock equivalents attributable to these preferred shares are 7,336,680 at June 30, 2011 and 8,531,196 at June 30, 2010. |
(2) | At June 30, 2011, there were common stock equivalents attributable to outstanding stock options of 8,352,914 common shares and 7,166,914 common shares at June 30, 2010. The stock options are under water at June 30, 2011 and anti-dilutive at June 30, 2010 and therefore have been excluded from diluted earnings per share. |
(3) | At June 30, 2011, there were common stock equivalents of 18,498,636 and 18,712,923 common stock equivalents at June 30, 2010, attributable to warrants. The warrants expire on September 30, 2012. The warrants underwater at June 30, 2011 and are anti- dilutive at June 30, 2010 and therefore have been excluded from diluted earnings per share. |
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9. License Agreement
In September 1988, the Company entered into a license agreement with the Regents of the University of Minnesota (the “Regents”), whereby the Company was granted a license to utilize certain technology developed by the Regents. Under the license agreement, the Company is required to pay royalties on net product revenue containing the technology licensed from the Regents. In the first two years after execution of the agreement, royalties were 1% of net revenue, and for the third and fourth years were 1.5% of net revenue. Beginning in the fifth year, and continuing through the termination of the agreement, royalties were 2% of net revenue, and 3% if the Regents obtained a United States patent on any of the technology covered under the agreement, which occurred. Termination of the license agreement occurs with the expiration of the last patent, or ten years after the date of the first commercial product revenue, if no patent exists. Since the Regents have filed seven U.S. patents, the last of which expired on December 28, 2010. The requirement to pay a royalty under this license agreement for these patents expires concurrently with the expiration date of the last of these patents to expire, which was December 28, 2010. The license agreement remains in effect, even though these patents have expired. Royalties expense was $22,319 and $26,593 in fiscal years 2011 and 2010, respectively. As of June 30, 2011, total accrued royalties are $17,770.
10. Employee Benefit Plan
The Company maintains a Simplified 401(k) qualified retirement plan, which is funded by elective salary deferrals by employees. The Plan covers substantially all employees meeting minimum eligibility requirements. The Plan requires mandatory contributions by the Company. The Company makes contributions on behalf of qualifying contributing participants making elective deferrals in an amount equal to 100% of the elective deferral, not to exceed 3% of employee’s compensation. The matching contributions expense amounted to $10,019 and $8,718 in fiscal years 2011 and 2010, respectively.
11. Commitments
The Company entered into a non-cancelable operating lease agreement for approximately 6,900 square feet of office/warehouse space. Effective September 8, 2010, the term of this operating lease was extended for forty-eight (48) months from November 1, 2010 to October 31, 2014. Rent expense was $73,702 and $77,576 in fiscal years 2011 and 2010, respectively.
The following is a schedule of future minimum lease payments due as of June 30, 2011:
Year ending June 30: | |||||||
2012……………………………………………………………………………….. | $ | 72,186 | |||||
2013……………………………………………………………………………….. | $ | 73,506 | |||||
2014……………………………………………………………………………….. | $ | 74,873 | |||||
2015……………………………………………………………………………….. | $ | 25,112 |
12. Significant Customers and Credit Risk
Revenue from the Company’s products is concentrated among specific customers in the same industry. The Company generally does not require collateral. While no direct (physical) customer accounted for more than 10% of total revenue in the years ended June 30, 2011 and 2010, respectively, one distributor accounted for approximately 80% and 68% of unit sales in the years ended June 30, 2011 and 2010, respectively.
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13. Quarterly Financial Data (unaudited, in thousands, except per share data)
First | Second | Third | Fourth | |||||||||||||
Quarter | Quarter | Quarter | Quarter | |||||||||||||
June 30, 2011: | ||||||||||||||||
Revenue | $ | 257 | $ | 458 | $ | 347 | $ | 327 | ||||||||
Gross Profit | 219 | 365 | 262 | 267 | ||||||||||||
Net income (Loss) | 264 | (181 | ) | (102 | ) | 425 | ||||||||||
Basic and Diluted | ||||||||||||||||
Net income (loss) per common share | 0.01 | (0.01 | ) | 0.00 | 0.01 | |||||||||||
June 30, 2010: | ||||||||||||||||
Revenue | $ | 302 | $ | 458 | $ | 126 | $ | 497 | ||||||||
Gross Profit | 269 | 415 | 103 | 616 | ||||||||||||
Net income (Loss) | (780 | ) | (233 | ) | (334 | ) | 357 | |||||||||
Basic and Diluted | ||||||||||||||||
Net income (loss) per common share | (0.02 | ) | 0.00 | (0.01 | ) | 0.01 |
14. Litigation
Although we have been involved in various legal actions in the ordinary course of our business, currently we are not aware of any pending legal proceedings against or involving us.
15. Subsequent Events
On August 26, 2011 (the “Effective Date”), the Company entered into and closed a definitive Asset Purchase Agreement (the “Agreement”) providing for the sale of selected assets to Cohn Prevention Center, LLC (“CPC”), a Minnesota company, a related party board member and stockholder.
The terms of the Agreement provide for the sale of selected operating assets of the Company’s medical device business (including inventory but excluding cash, accounts receivable, and intellectual property). The Agreement does not limit the ability of CPC to sell the existing inventory of the Company’s parts/products to any customer or in any market where they can be legally sold. Additionally, CPC has agreed to assume all warranty and on-going product support required by regulatory agencies.
In connection with the Agreement, CPC paid the Company on the Effective Date a cash payment of $125,000 and issued a secured promissory note to the Company in the amount of either $150,000 in 12 months or $200,000 in 18 months at the discretion of CPC. Additionally, CPC agreed to pay the Company a cash payment of $1,200 on each of the first 50 units sold within 30 days of receipt of cash from any unit sale made by CPC. Nearly all of the proceeds received at closing will be allocated to cover severance and other costs related to the transaction.
The Company and CPC also entered into a Sublicense Agreement on the Effective Date (the “Sublicense Agreement”), pursuant to which the Company grants CPC a limited license which allows the use of the Company’s intellectual property, technology, and technical know-how for the use of its arterial elasticity measurement technology exclusively in CPC clinics and research related exclusively to CPC clinics. All other applications of the intellectual property, technology and technical know-how will be retained by the Company for the benefit of the Company. Any development of a next generation arterial measurement device, however, would be limited exclusively to use and sale within the CPC network of clinics and to research exclusively related to CPC clinics.
CPC and the Company have also entered into a Sublease Agreement as of the Effective Date with CPC for the Waters II Suite 108 facility on the same pass-through economic terms as the Company has with the existing landlord for the remaining term of the Company’s lease, which expires October 31, 2014.
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15. Subsequent Events (continued)
Upon the closing of this transaction, the Company will have limited operations and intends to seek additional opportunities to license its proprietary technology, intellectual property, technical know-how and other core assets, although there is no assurance these efforts will be successful.
ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
We have not had any disagreements with our current auditors.
ITEM 9A. Controls and Procedures
(a) Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our Chief Executive Officer and principal financial officer, Mark N. Schwartz, and members of our accounting staff, we have evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined under Rule 13a-15(e) and 15d-15(e) promulgated under the Securities and Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this report. Based upon that review, our Chief Executive Officer and principal financial officer have concluded that, as of the evaluation date, our disclosure controls and procedures were effective.
(b) Management’s Annual Report on Internal Controls Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Securities Exchange Act of 1934, as amended). Our internal control system is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with generally accepted accounting principles.
Under the supervision and with the participation of management, including our Chief Executive Officer and principal financial officer, our management assessed the design and operating effectiveness of internal control over financial reporting as of June 30, 2011 based on criteria established in “Internal Control-Integrated Framework” issued by the Committee of the Sponsoring Organizations of the Treadway Commission (“COSO”).
Based on this assessment, management concluded that our internal controls over financial reporting were effective as of June 30, 2011.
(c) Changes in Internal Control Over Financial Reporting
There have been no significant changes in our internal control over financial reporting that occurred during the fourth quarter ended June 30, 2011, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. Other Information
None.
PART III
ITEM 10. Directors and Executive Officers of the Registrant
Our Articles of Incorporation and Bylaws provide that the Board of Directors is classified into three classes, Class I, II and III, with the members of each class to serve (after an initial transition period) for a staggered term of three years. Messrs. Leitner and Stern were each designated as a Class I director; Mr. Guettler was designated as a Class II director; and Messrs. Brimmer and Schwartz and Dr. Cohn were each designated as a Class III director. While the terms of each class have expired, pursuant to the Company’s Bylaws each director shall serve until their successor has been duly elected.
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Name | Age | Position | Director Since |
Larry Leitner (1) (2) | 58 | Director | 2003 |
Alan Stern (1) (2) | 56 | Director | 2003 |
Greg H. Guettler | 57 | President, Secretary and Director | 1997 |
Mark N. Schwartz | 55 | Chief Executive Officer and Chairman of the Board of Directors | 2003 |
Kenneth W. Brimmer(1) (2) | 56 | Director | 1995 |
Jay N. Cohn, M.D. | 81 | Director | 1988 |
(1) Member of the Audit Committee
(2) Member of the Compensation Committee
Larry Leitner – Mr. Leitner is a founding partner of Specialty Commodities, Inc., (“Specialty”) an international commodities importing, trading, and distribution company established in 1987 with offices and warehouses in Los Angeles, California and Fargo, North Dakota. Specialty is one of the largest importers and distributors of nuts, dried fruits, seeds, and grains, supplying the snack food, health, food, bakery and bird food industries in North America and Europe. He received his Bachelor of Science degree from North Dakota State University.
Alan Stern – Mr. Stern is a founding partner of Specialty Commodities, Inc., an international commodities importing, trading, and distribution company established in 1987 with offices and warehouses in Los Angeles, California and Fargo, North Dakota. He received his Bachelor of Arts degree from the City of London School of Business Studies (City University).
Greg H. Guettler – Mr. Guettler has been our President and a Director since September 1997. Mr. Guettler has more than 25 years of experience in sales, marketing and management positions within the medical industry. Prior to joining us, from May 1983 to September 1997, Mr. Guettler was a senior manager at Universal Hospital Services, Inc. Mr. Guettler holds a Bachelor of Arts degree from the University of St. Thomas in St. Paul, Minnesota (1977) and a Master of Business Administration degree (M.B.A.) from the University of St. Thomas Graduate School of Management in St. Paul, Minnesota (1983). Effective August 26, 2011, Mr. Guettler resigned as a Director of the Company.
Mark N. Schwartz – Mr. Schwartz has been our Chief Executive Officer and Chairman of our Board since September 2003. From November 1999 to August 2003, Mr. Schwartz was Chief Financial Officer and served on the Board of Directors of DDD Group plc, a digital media company focused on developing 3D technology for the corporate and consumer markets, which is publicly traded on the London Stock Exchange’s Alternative Investment Market, or AIM. Previously, he founded and was Chief Financial Officer of Bodega Latina Corporation, a Latino oriented grocery retailer operating warehouse supermarkets. From 1982 to 1985, Mr. Schwartz was an investment banker at Credit Suisse First Boston and Donaldson Lufkin & Jenrette, where he secured, structured and negotiated the first round of institutional financing for Starbucks Coffee and also served on its Board of Directors. He received a Bachelor of Arts degree in economics and political science from Claremont McKenna College and a Masters of Business Administration degree with honors from Harvard Business School.
Kenneth W. Brimmer – Mr. Brimmer was elected to our Board of Directors in November 1995, and served as the Chairman of our Board from June 5, 2000 to August 28, 2003. Since May of 2009, Mr. Brimmer has been CEO and principal shareholder of Stencor Company, LLC a privately-owned plastic injection molding and contract manufacturing business. Mr. Brimmer served as a director of STEN Corporation from 1998 until May 2009 and CEO of the company since October 2003. Since December 2001, Mr. Brimmer has also served as Chief Manager of Brimmer Company, LLC. Previously, Mr. Brimmer was President of Rainforest Cafe, Inc. from April 1997 until April 2000 and was Treasurer of Rainforest Café from its inception during 1995 until April 2000. Mr. Brimmer has served on the Board of Directors of Landrys Restaurants, Inc. since June 2004. Landrys Restaurants is a restaurant and casino operator with more than a billion dollars in revenue. Landrys was listed on the New York Stock Exchange until going private in 2010. Mr. Brimmer holds a Bachelor of Arts degree in accounting from Saint John’s University in Collegeville, Minnesota (1977).
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Jay N. Cohn, M.D. – Dr. Cohn has served as a member of our Board of Directors since our inception in July 1988. Since 1974, Dr. Cohn has been employed by the University of Minnesota Medical School as a Professor of Medicine and he was Head of its Cardiovascular Division from 1974 through 1997. Dr. Cohn discovered that arterial elasticity indices could be determined from blood pressure waveforms in the late 1970’s and he is a co-inventor of the pulse contour analysis technology used in our CardioVascular Profiling System Products. Dr. Cohn also serves as Chairman of the Board of Directors of Cohn Prevention Centers (CPC), a development stage company intending to create a nationwide network of clinics providing cardiovascular health assessment. Dr. Cohn received his M.D. degree from Cornell University (1956). Dr. Cohn resigned as a director of the Company effective August 26, 2011.
(b) Family Relationships |
There are no family relationships among any of our directors and executive officers. There are no family relationships among our officers, directors, or persons nominated for such positions.
(c) Legal Proceedings
No officer, director, or persons nominated for these positions, and no promoter or significant employee of our corporation has been involved in legal proceedings that would be material to an evaluation of our management.
(d) | Audit Committee |
The Board of Directors has an Audit Committee currently comprised of Kenneth W. Brimmer, Larry Leitner and Alan Stern. Kenneth W. Brimmer is serving on our audit committee as an audit committee financial expert. The Audit Committee operates under an Audit Committee Charter, adopted effective June 5, 2000, amended and restated on October 31, 2003 and on July 15, 2010. Each of the members of the Audit Committee is an independent director as defined by The Nasdaq Stock Market, Inc. listing standards. The Audit Committee of the Board of Directors is responsible for the selection and approving the compensation of the independent auditors, providing independent, objective oversight of our financial reporting system by overseeing and monitoring management’s and the independent auditors’ participation in the financial reporting process.
(e) | Compensation Committee |
The Board of Directors has a Compensation Committee currently comprised of Kenneth W. Brimmer, Larry Leitner and Alan Stern. Each of the members of the Compensation Committee is an independent director as defined by The Nasdaq Stock Market, Inc. listing standards. The Compensation Committee of the Board of Directors is responsible for recommending compensation programs for our executive management and equity-based compensation for employees, officers, and consultants.
Code of Ethics
We adopted a code of ethics that applies to our principal chief executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions (the "Code of Ethics"). A copy of the Code of Ethics can be obtained, and will be provided to any person without charge, upon written request to the Company’s Secretary at the Company’s headquarters address. The Code of Ethics is also available on our website, located at www.hdii.com.
Section 16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) requires our directors and executive officers and beneficial holders of more than 10% of our common stock to file with the Commission initial reports of ownership and reports of changes in ownership of our equity securities. As of the date of this Report, we believe that all reports needed to be filed have been filed in a timely manner for the year ended June 30, 2011. In making this statement, we have relied solely on copies of any reporting forms received by us.
ITEM 11. Executive Compensation
The following table sets forth the cash and non-cash compensation for the years indicated earned by or awarded to (i) each individual serving as our principal executive officer during our last completed fiscal year (ii) each other individual that served as our executive officer at the end of our last completed fiscal year, and (iii) any individual whose total compensation exceeded $100,000 during the last completed fiscal year but was not an executive officer at the end of such last completed fiscal year (the “Named Executives”).
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Summary Compensation Table
Name and Principal Position | Year | Salary | Bonus | Stock Awards | Option Awards | Non-Equity Incentive Plan Compensation | Nonqualified Deferred Compensation Earnings | All Other Compensation ($) | Total ($) | |||||
(a) | (b) | (c) | (d) | (e) | (f) | (g) | (h) | (i) | (j) | |||||
Mark Schwartz | 2011 | $ | 133,097 | $ | 135,000 | (1) | $ | 268,097 | ||||||
Chief Executive Officer | 2010 | $ | 134,723 | $ | 324,000 | (1) | $ | 458,723 | ||||||
Greg H. Guettler | 2011 | $ | 181,000 | $ | 40,000 | (2) | $ | 221,000 | ||||||
President and Secretary | 2010 | $ | 187,961 | $ | 44,000 | (2) | $ | 231,961 |
(1) | Amount of Stock Award reflects the value of the Phantom Stock of 2,700,000 shares awarded in fiscal year ending June 30, 2011 and 2,400,000 shares awarded in fiscal year ending June 30, 2010 to Mr. Schwartz pursuant to the Deferred Equity Incentive Agreement multiplied by the closing stock price at the end of each fiscal year, $0.06 at June 30, 2011, and $0.135 at June 30, 2010. |
(2) | Amount of stock awards reflects the value of stock options granted of 400,000 for each of the years ended June 30, 2011 and 2010. |
The following table sets forth information concerning outstanding equity awards held by Named Executive Officers and Employees at June 30, 2011.
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Outstanding Equity Awards At Fiscal Year-End
Option Awards | Stock Awards | ||||||||
Name | Number of Securities Underlying Unexercised Options Exercisable | Number of Securities Underlying Unexercised Options Unexercisable | Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options | Option Exercise Price | Option Expiration Date | Number of Shares or Units of Stock That Have Not Vested | Market Value of Shares or Units of Stock That Have Not Vested | Equity Incentive Plan Awards: Number of Earned Shares, Units or Other Rights That Have Vested | Equity Incentive Plan Awards: Market or Payout Value of Earned Shares, Units or Other Rights That Have Vested |
(#) | (#) | (#) | ($) | (#) | ($) | (#) | ($) | ||
(a) | (b) | (c) | (d) | (e) | (f) | (g) | (h) | (i) | (j) |
Mark N. Schwartz | 12,450,000 | $622,500 | |||||||
(1) | (2) | ||||||||
Greg H. Guettler | 171,080 | 0.165 | 12/15/14 | ||||||
25,000 | 1.000 | 06/11/12 | |||||||
150,000 | 0.180 | 05/29/13 | |||||||
63,786 | 0.165 | 12/15/14 | |||||||
400,000 | 0.200 | 12/17/13 | |||||||
424,943 | 0.165 | 12/15/14 | |||||||
150,000 400,000 400,000 | 0.200 0.110 0.100 | 08/03/16 12/16/19 12/17/20 |
(1) | Amount of Equity Incentive Plan Awards reflects the total number of Phantom Stock shares accumulated by Mr. Schwartz since inception of the Deferred Equity Incentive Agreement effective January 1, 2006. |
(2) | Market Value of Unearned Shares reflects the value of the accumulated Phantom Stock shares multiplied by the closing stock price at the end of each fiscal year. |
Employment Agreement
In connection with the August 2003 Private Placement, we entered into an employment agreement dated August 28, 2003 with Mr. Schwartz to serve as our Chief Executive Officer and Chairman of the Board. Pursuant to such employment agreement, Mr. Schwartz was provided a monthly salary of $6,000 cash. Effective March 1, 2005, the Compensation Committee of the Board of Directors approved an increase in the monthly cash salary from $6,000 to $7,000. Effective March 27, 2006, the Compensation Committee approved an increase in the monthly cash salary from $7,000 to $8,333. Effective September 10, 2007, the compensation Committee approved an increase in the monthly cash salary from $8,333 to $9,333. In addition, the employment agreement provides that a bonus or incentive compensation to be paid in shares of our common stock shall be approved by the Compensation Committee
On June 5, 2006, we entered into a Deferred Equity Incentive Agreement (the “Agreement”) with Mr. Schwartz. The effective date of this Agreement is January 1, 2006. Under the terms and conditions of this Agreement, the Company shall grant to Mr. Schwartz certain equity incentive compensation units (“Units”) that would: (1) have a current value related to the net value of our voting common stock; (2) increase or decrease with any future changes in the value of that stock; (3) be payable in cash only upon certain events; and (4) be payable in 2012 without regards to events. For the period January 1, 2009 through December 31, 2009, we will grant to Mr. Schwartz one hundred seventy-five thousand (175,000) phantom units each month. Effective January 1, 2010, the board of directors increased the number of units in the Agreement to 225,000 per month. As of June 30, 2011, the Company has accrued $622,500 in stock compensation benefit relating to this Agreement.
On September 10, 2007, the Compensation Committee approved for Mr. Greg Guettler an increase in the monthly cash salary from $14,000 to $15,083.
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Compensation of Directors
Members of our Board of Directors receive no cash compensation for such service. On November 28, 2006, an option to purchase 480,000 shares of our common stock was granted to Jay Cohn and an option to purchase 450,000 shares each was granted to Alan Stern, Larry Leitner and Ken Brimmer at an exercise price of $0.16 per share, which would vest annually in equal increments over a three year period in accordance with the terms of our 2005 Stock Option Plan. On December 17, 2010, each director was awarded an option to purchase 225,000 shares (totaling 900,000 shares of our common stock) at an exercise price of $0.10 per share, which would vest quarterly over a 12-month period.
ITEM 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Equity Compensation Plan Information
Plan Category | Number of securities to be issued upon exercise of outstanding options, warrants and rights | Weighted-average exercise price of outstanding options, warrants and rights | Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a) | |
(a) | (b) | (c) | ||
Equity compensation plans approved by shareholders | 1995 Plan: 1998 Plan: 2003 Plan: | 260,000 669,572 3,843,342 | $0.17 $0.33 $0.17 | 0 0 141,658 |
2005 Plan: | 3,580,000 | $0.13 | 2,420,000 | |
Total | 8,352,914 | $0.26 | 2,561,658 | |
Security Ownership - Certain Beneficial Owners
Beneficial ownership is shown as of September 24, 2011 for shares held by (i) each person or entity known to us to be the beneficial owner of more than 5% of our issued and outstanding shares of common stock based solely upon a review of filings made with the Commission and our knowledge of the issuances by us, (ii) each of our directors, (iii) our Chief Executive Officer and our two other most highly compensated officers whose compensation exceeded $100,000 during the fiscal year ended June 30, 2011, or the Named Executive Officers, and (iv) all of our current directors and executive officers as a group. Unless otherwise indicated, the persons listed below have sole voting and investment power with respect to the shares and may be reached at 10275 Wayzata Blvd, Suite 310, Minnetonka, MN 55305.
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Beneficial Owner | Class | Shares | Shares Presently Acquirable Within 60 Days (1) | Total | Percentage of Class Beneficially Owned |
Mark N. Schwartz (2) (3) | Common | 5,290,483 | 606,606 | 5,897,089 | 14.19% |
Preferred | 0 | 38,145 | 38,145 | 4.87% | |
Combined | 5,290,483 | 1,064,346 | 6,354,829 | 12.62% | |
Larry Leitner (2) | Common | 1,317,493 | 1,310,329 | 2,627,822 | 6.22% |
Preferred | 0 | 28,160 | 28,160 | 3.64% | |
Combined | 1,317,493 | 1,648,249 | 2,965,742 | 5.90% | |
Alan Stern (2) | Common | 1,265,631 | 1,342,889 | 2,608,520 | 6.17% |
Preferred | 0 | 30,208 | 30,208 | 3.90% | |
Combined | 1,265,631 | 1,705,385 | 2,971,016 | 5.91% | |
Greg H. Guettler (2) (3) | Common | 45,356 | 1,507,202 | 1,552,558 | 3.66% |
Preferred | 0 | 1,408 | 1,408 | 0.19% | |
Combined | 45,356 | 1,524,098 | 1,569,454 | 3.14% | |
Jay N. Cohn (2) | Common | 1,198,764 | 1,645,245 | 2,844,009 | 6.67% |
Preferred | 0 | 42,240 | 42,240 | 5.37% | |
Combined | 1,198,764 | 2,152,125 | 3,350,889 | 6.65% | |
Kenneth W. Brimmer (2) | Common | 196,992 | 1,032,851 | 1,229,843 | 2.93% |
Preferred | 0 | 9,856 | 9,856 | 1.31% | |
Combined | 196,992 | 1,151,123 | 1,348,115 | 2.70% | |
All Officers and Directors | Common | 9,314,719 | 7,445,121 | 16,759,840 | 34.62% |
as a Group (6 individuals) | Preferred | 0 | 150,017 | 150,017 | 16.77% |
Combined | 9,314,719 | 9,245,325 | 18,560,044 | 35.90% | |
Marten Hoekstra | Common | 2,038,769 | 1,119,538 | 3,158,307 | 7.51% |
Preferred | 0 | 70,399 | 70,399 | 8.64% | |
Combined | 2,038,769 | 1,964,320 | 4,003,089 | 7.89% | |
(1) | Shares of common stock subject to options and warrants that are currently exercisable or exercisable within 60 days are deemed to be beneficially owned by the person holding the options and warrants for computing such person’s percentage, but are not treated as outstanding for computing the percentage of any other person. |
(2) | Director. |
(3) | Named Executive Officer. |
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ITEM 13. Certain Relationships and Related Transactions
None.
ITEM 14. Principal Accountant Fees and Services
The following is a summary of the fees billed to us by our current independent accountant Moquist Thorvilson Kaufmann Kennedy & Pieper, LLC (“MTK”) for professional services rendered for the years ended June 30, 2011 and 2010:
2011 | 2010 | ||
Service | MTK | MTK | |
Audit Fees | $37,667 | $35,750 | |
Audit Related Fees | -0- | -0- | |
Tax Fees | 256 | -0- | |
All other Fees | -0- | -0- | |
TOTAL | $37,923 | $35,750 |
Audit fees consist of the aggregate fees billed for professional services rendered for the audit of our annual financial statements, the reviews of the financial statements included in our Forms 10-Q and for any other services that are normally provided by MTK in connection with our statutory and regulatory filings or engagements.
Audit related fees consist of the aggregate fees billed for professional services rendered for assurance and related services that were reasonably related to the performance of the audit or review of our financial statements that were not otherwise included in Audit Fees.
Tax fees consist of the aggregate fees billed for professional services rendered for tax compliance, tax advice and tax planning. These services include assistance regarding federal, state and local tax compliance and consultation in connection with various transactions and acquisitions.
All other fees consist of the aggregate fees billed for products and services provided by VK and MTK and not otherwise included in Audit Fees, Audit Related fees or Tax Fees.
The policy of our Audit Committee is to review and pre-approve both audit and non-audit services to be provided by the independent auditors (other than with de minimis exceptions permitted by the Sarbanes-Oxley Act of 2002). This duty may be delegated to one or more designated members of the Audit Committee with any such approval reported to the committee at its next regularly scheduled meeting. Approval of non-audit services shall be disclosed to investors in periodic reports required by section 13(a) of the Securities Exchange Act of 1934, as amended. All of the fees paid to VK and MTK were pre-approved by the audit committee.
No services in connection with appraisal or valuation services, fairness opinions or contribution-in-kind reports were rendered by MTK. Furthermore, no work of MTK with respect to its services rendered to us was performed by anyone other than MTK.
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PART IV
ITEM 15 Exhibits, Financial Statement Schedules
(a) | Financial Statements |
Report of Independent Registered Public Accounting Firm 31
Audited Financial Statements
Balance Sheets 33
Statements of Operations 34
Statements of Shareholders’ Equity 35
Statements of Cash Flows 36
Notes to Financial Statements 37
(b) | Exhibits |
3.1 | Articles of Incorporation | Exhibit 3.1 of the Company’s Registration Statement on Form SB-2 (File No. 333-53025) filed on May 19, 1998, or the 1998 Registration Statement |
3.2 | Bylaws | Exhibit 3.2 of the Company’s 1998 Registration Statement. |
3.3 | Articles of Amendment of Incorporation dated June 2, 1998 | Exhibit 3.3 of the Company’s 1998 Registration Statement. |
4.1 | Specimen of common stock Certificate | Exhibit 4.1 of the Company’s 1998 Registration Statement. |
4.2 | Specimen of Redeemable Class B Warrant Certificate | Exhibit 4.6 of Registration Statement on Form S-3 (File No. 333-53200) as dated January 4, 2001 and as subsequently amended. |
4.4 | Amendment No. 1 dated October 17, 2002 to Amended and Restated Class B Warrant Agreement between Hypertension Diagnostics, Inc. and Mellon Investor Services, LLC. | Exhibit 4.2 of Current Report on Form 8-K dated October 17, 2002. |
4.8 | Form of Common Stock Purchase Warrant issued dated March 27, 2002. | Exhibit 10.3 of the Current Report on Form 8-K dated March 27, 2002. |
4.11 | Certificate of Designation, Preferences and Rights of Series A Convertible Preferred Stock | Exhibit 4.1 of the Company’s Current Report on Form 8-K dated August 28, 2003, or the August 8-K |
4.13 | Form of Common Stock Warrant originally issued August 28, 2003. | Exhibit 4.7 of the August 8-K. |
4.14 | Form of Preferred Stock Purchase Warrant originally issued August 28, 2003. | Exhibit 4.6 of the August 8-K. |
4.15 | Registration Rights Agreement dated as of August 28, 2003 among Hypertension Diagnostics, Inc. and the Purchaser parties thereto. | Exhibit 4.4 of the August 8-K. |
4.16 | Shareholders’ Agreement dated as of August 28, 2003 by and among Hypertension Diagnostics, Inc. and the holders of Hypertension Diagnostics, Inc. Series A Convertible Preferred Stock. | Exhibit 4.5 of the August 8-K. |
4.17 | Form of Irrevocable Proxy executed in connection with the Securities Purchase Agreement dated as of August 28, 2003. | Exhibit 4.8 of the August 8-K. |
4.18 | Form of Irrevocable Proxy dated August 4, 2003 executed by Messrs. Brimmer, Cohn, Guettler, Murphy and Dr. Chesney. | Exhibit 4.10 of the August 8-K. |
9.1 | Voting Agreement dated as of August 28, 2003 by and among the holders of Hypertension Diagnostics, Inc. Series A Convertible Preferred Stock. | Exhibit 4.3 of the August 8-K. |
10.1 | 1995 Long-Term Incentive and Stock Option Plan * | Exhibit 10.1 of the Company’s 1998 Registration Statement. |
10.2 | 1998 Stock Option Plan * | Exhibit 10.2 of the Company’s 1998 Registration Statement. |
10.3 | Form of Stock Option Agreement for 1998 Stock Option Plan * | Exhibit 10.3 of the Company’s 1998 Registration Statement. |
10.5 | Research and License Agreement between the Company and the Regents of the University of Minnesota, dated September 23, 1998 | Exhibit 10.4 of the Company’s 1998 Registration Statement. |
10.8 | Manufacturing Services Agreement between Apollo Research Corporation and the Company, dated May 14, 1998 | Exhibit 10.13 of the Company’s 1998 Registration Statement. |
10.15 | Letter Agreement dated February 21, 2001 by and between Hypertension Diagnostics, Inc. and Apollo Research Corporation, M. Terry Riggs and Randy Thorton | Exhibit 10.14 of the Company’s Annual Report on Form 10-KSB for the year ended June 30, 2003. |
10.16 | Employment Agreement between Mark Schwartz and the Company, dated August 28, 2003* | Exhibit 10.16 of the Company’s Annual Report on Form 10-KSB for the year ended June 30, 2004 |
10.17 | Deferred Equity Incentive Agreement between Mark N. Schwartz and the Company, dated June 5, 2006* | Filed Herewith. |
10.18 | 2003 Stock Option Plan* | Exhibit 10.1 of the Company’s 2006 Form S-8 Registration Statement |
10.19 | 2005 Stock Option Plan* | Exhibit 10.2 of the Company’s 2006 Form S-8 Registration Statement |
23.1 | Consent of Independent Registered Public Accounting Firm | Filed Herewith. |
31.1 | Certification of Chief Executive Officer and Principal Financial Officer pursuant to 13a-14 and 15d-14 of the Exchange Act | Filed Herewith. |
32.1 | Certificate pursuant to 18 U.S.C. § 1350 | Filed Herewith. |
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SIGNATURES
In accordance with Section 13 or 15(d) of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
HYPERTENSION DIAGNOSTICS, INC.
/s/ MARK N. SCHWARTZ
MARK N. SCHWARTZ, Chief Executive Officer
(Principal executive officer)
Dated: September 15, 2011
In accordance with the requirements of the Exchange Act, this report has been signed below on behalf of the registrant and in the capacities indicated on September 15, 2011.
Each person whose signature appears below constitutes and appoints Mark N. Schwartz as his true and lawful attorneys-in-fact and agents, each acting alone, with full power of substitution and resubstitution, for him and in his name, place and stead, in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K and to file the same, with all exhibits thereto, and other documents in connection therewith, with the U.S. Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, each acting alone, full power and authority to do and perform each and every act and thing requisite and 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 said attorneys-in-fact and agents, each acting alone, or his substitute or substitutes, may lawfully do or cause to be done by virtue thereof.
Signature | Title |
/s/ MARK N. SCHWARTZ Mark N. Schwartz | Chairman of the Board of Directors, Chief Executive Officer and Principal Financial Officer (Principal executive officer) |
/s/ LARRY LEITNER | Director |
Larry Leitner | |
/s/ ALAN STERN | Director |
Alan Stern | |
/s/ KENNETH W. BRIMMER | Director |
Kenneth W. Brimmer | |
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