GLOBAL WHOLEHEALTH PARTNERS CORPORATION Forward-Looking Statements
This Report on Form 10-Q contains forward-looking statements which involve assumptions and describe our future plans, strategies, and expectations, and are generally identifiable by use of words such as "may," "will," "should," "expect," "anticipate," "estimate," "believe," "intend," or "project," or the negative of these words or other variations on these words or comparable terminology. These statements are expressed in good faith and based upon a reasonable basis when made, but there can be no assurance that these expectations will be achieved or accomplished.
Such forward-looking statements include statements regarding, among other things, (a) the potential markets for our products, our potential profitability, and cash flows, (b) our growth strategies, (c) anticipated trends in the in-vitro diagnostics industry, (d) our future financing plans, and (e) our anticipated needs for working capital. This information may involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from the future results, performance, or achievements expressed or implied by any forward-looking statements. These statements may be found under "Management's Discussion and Analysis of Financial Condition and Results of Operations" as well as in this Form 10-Q generally. Actual events or results may differ materially from those discussed in forward-looking statements as a result of various factors, including, without limitation, the matters described in this Form 10-Q generally. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements contained in this filing will in fact occur. In addition to the information expressly required to be included in this filing, we will provide such further material information, if any, as may be necessary to make the required statements, in light of the circumstances under which they are made, not misleading.
Although forward-looking statements in this report reflect the good faith
judgment of our management, forward-looking statements are inherently subject to
known and unknown risks, business, economic and other risks and uncertainties
that may cause actual results to be materially different from those discussed in
these forward-looking statements. Readers are urged not to place undue reliance
on these forward-looking statements, which speak only as of the date of this
report. We assume no obligation to update any forward-looking statements in
order to reflect any event or circumstance that may arise after the date of this
report, other than as may be required by applicable law or regulation. Readers
are urged to carefully review and consider the various disclosures made by us in
our filings with the
Except where the context otherwise requires and for purposes of this Form 10-Q
only, "we" "us" "our" "Company" "our Company" and "
Overview
The Company was founded to develop, manufacture and market in-vitro diagnostic
("IVD") tests for over-the-counter ("OTC" or consumer), or consumer-use and
point-of-care ("POC" or professional) which includes hospitals, physicians'
offices and medical clinics, including those within penal systems throughout the
US and abroad. The Company currently manufactures and markets a range of
diagnostic test kits for consumer use through OTC sales, and for use by health
care professionals, generally located at medical clinics, physician offices and
hospitals known POC, in
The Company believes, according to publicly available sources, that the IVD
industry is a multi-billion dollar industry that is increasing each year. This
assessment includes all laboratory hospital-based products, OTC devices, and
rapid tests performed at the point-of-care. The Company believes that the
following factors can be attributed to the increase in overall need and use of
IVD test kits: an aging baby-boomer population; increasing healthcare costs; the
ever-growing number of uninsured and under-insured in the
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The concepts that distinguish POC technology-operation simple enough for non-laboratory users; little or no maintenance requirement; and rapid, reliable results-mean that it can be applied equally well in many non-clinical settings, such as the OTC market. As advances in medical technology increasingly make it possible to diagnose diseases and physiological conditions from ever-smaller amounts of body fluids, certain diseases and conditions that once required diagnosis by physicians and/or medical technicians inside hospital emergency rooms, exam rooms/bedside studies, or private clinics, can now also be done by inexpensive, easy-to-use diagnostic devices that consumers can use in the comfort and anonymity of their home. Today, the average pharmacy, whether a privately owned neighborhood store, or chain owned, has become an outlet for selling IVD test kits for in-home use.
All of the products we sell are manufactured in an FDA Approved Facility in the
Industry
The use of diagnostics in quality measures often is supported by clinical
practice guidelines. Of all the quality measures contained in The Healthcare
Effectiveness Data and Information Set ("HEDIS") is a widely used set of
performance measures in the managed care industry, developed and maintained by
the
Of course, the development of measures for HEDIS, NQMC and other quality assessment initiatives is a relatively new process and represents only a sample of evidence-based use of diagnostics. Nevertheless, this analysis conveys the essential role of diagnostics in health care quality. Further, the incorporation of diagnostics into quality measures serves as a benchmark for assessing underuse of diagnostics and the health and economic impact of such underuse.
In its annual report on the state of health care quality in the US,
Figure 7.7 Relationship between Application of Selected HEDIS Diagnostic Quality Measures and Avoidable Adverse Health Events, Deaths and Costs
Percent
HEDIS Quality Measure National
Under-use in Estimated Estimated
HEDIS Estimated Annual Annual Annual
Compliant Avoidable Adverse Avoidable Avoidable
Health Plans Health Events Deaths Costs
Breast cancer screening 19.3% 7,600 breast 600-1,000
cancer
(biopsy, needle cases treated in
Stage
aspiration or IV due to late
mammography) diagnosis
Cholesterol management 48.9 14,600 major 6,900-17,000
coronary events
Colorectal cancer 51.9 20,000 cases of 4,200-6,300
colorectal cancer
(FOBT or colonoscopy) diagnosed/treated
at a
later stage
Diabetes management 20.2 14,000 heart 4,300-9,600 $573 million
(HbA1c control) attacks, strokes,
or amputations
549 State of health care quality: industry trends and analysis.
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These and other findings of the 2004
Health care increasingly is subject to demands for improved health and quality of life and constraints on the spending required to deliver these improvements. In vitro diagnostics, henceforth in this report referred to as diagnostics, aid in responding to such demands by enabling accurate detection of health risks and disease at earlier stages and improving treatment and disease management, while diminishing subsequent health problems and their associated costs. Diagnostics serve a key role in the health value chain by influencing the quality of patient care, health outcomes, and downstream resource requirements.
From consumer-friendly at-home pregnancy and glucose monitoring tests to more complex automated laboratory-based systems, these tests are often first-line health decision tools. While diagnostics comprise less than 5% of hospital costs and about 1.6% of all Medicare costs, their findings influence as much as 60-70% of health care decision-making. The value of diagnostics accrues to not only clinicians and patients, but to health care managers, third-party payers, and quality assurance organizations that use diagnostic performance to measure and improve health care quality.
The following data have been culled from various publicly available sources that the Company believes to be accurate but cannot guarantee it. The Company has attempted to provide conservative statistics and believe that it is generally known that the market for IVD products is significant and is continuing to grow.
The pregnancy test is one of the primary home tests used in the world. The
Company believes that approximately, 85,000 retail drug stores in the
The ovulation test market is generally estimated at
The glucose (diabetes) whole blood test is used to test for abnormal glucose
blood levels. A significant number of individuals are affected in
As mentioned in the table 7.7: Diabetes management: There are 14,000 heart
attacks, strokes, or amputations; 4,300-9,600 Deaths, but with Rapid Diagnostic
Testing an annual avoidable cost of
The Company's most recent OTC product is its colorectal test (colon disorders).
The Company estimates the demand for this test to increase with awareness of
availability. It knows of only one other company that is currently offering this
product. The colorectal Cancer screening tests helps detect the possibility of
cancer early and can saves thousands of lives and millions of dollars.
Colorectal cancer screening (FOBT) Fecal Occult Blood Test: 20,000 cases of
colorectal cancer diagnosed/treated at a later stage and 4,200-6,300 deaths, but
with Rapid Diagnostic Testing an annual avoidable cost of
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The Company's cholesterol OTC test and its cholesterol colorimetric POC test are
available to test for abnormal levels of cholesterol in whole blood. There is
evidence that a high blood cholesterol level increases the risk of developing
arteriosclerosis, and with it the risk of coronary heart disease or stroke. This
heart disease is the leading cause of death in
The market for drugs-of-abuse tests for the over-the-counter market is generally estimated to be one of the fastest growing markets of all IVD test products. At present, the Company believes that many law enforcement and governmental agencies are using laboratory testing facilities and must wait for results, often taking one week to ten days. The Company's tests are completed onsite within ten minutes.
A significant number of people are infected by the H-Pylori bacteria, which are associated with ulcers. The Company's H-Pylori test for the POC is one of its newest products.
All of the Company's diagnostic tests, over 90 products are available for international distribution. The Company believes that its tests are excellent for distribution and use in underdeveloped countries because, unlike lab and other rapid diagnostic tests, its test kits do not need refrigeration and can withstand extended periods of excessive heat.
Competition
Several companies around the world carry similar products, typically comprised
of approximately 10-30 different products. However, we carry the largest line of
products that we know of including over 100 products. As of
Marketing and Sales
The company plans on selling through large and small distributors, giving the company the greatest opportunity to sell to a greater amount of people, doctors, hospitals, clinics and governments.
Research and Development:
We are continuing to look for needs in the world to create and work with our scientific team and science partners to make a rapid test for the newest diseases, such as ZIKA, EBOLA, TB, and Malaria.
Results of Operations
Three and six months ended
Operating Expenses Professional Fees
Professional fees relate to expenditures incurred primarily for legal and
accounting services. During the three and six months ended
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Selling, General and Administrative
Selling, general and administrative ("SG&A") costs include all expenditures
related to personnel, travel and entertainment, public company compliance costs,
insurance and other office related costs. During the three and six months ended
Liquidity and Capital Resources
As of
Summary of Cash Flows
Presented below is a table that summarizes the cash provided or used in our activities and the amount of the respective increases or decreases in cash provided by (used in) those activities between the fiscal periods:
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