Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Corporate Overview
Our Company is a pattern recognition company that uses advanced mathematical techniques to analyze large amounts of data to uncover patterns that might otherwise be undetectable. The Company operates primarily in the field of molecular diagnostics where such tools are critical to scientific discovery. The terms artificial
intelligence and machine learning are sometimes used to describe pattern recognition tools.
HDC’s mission is to use its patents, intellectual prowess, and clinical partnerships principally to identify patterns that can advance the science of medicine, as well as to advance the effective use of our technology in other diverse business disciplines, including the high-tech, financial, and healthcare technology markets.
Our historical foundation lies in the molecular diagnostics field where we have made a number of discoveries that play a critical role in developing more personalized approaches to the diagnosis and treatment of certain diseases. However, our SVM assets in particular have broad applicability in many other fields. Intelligently applied, HDC’s pattern recognition technology can be a portal between enormous amounts of otherwise undecipherable data and truly meaningful discovery.
Our Company’s principal asset is its intellectual property which includes advanced mathematical algorithms called Support Vector Machines (SVM) and Fractal Genomic Modeling (FGM), as well as biomarkers that we discovered by applying our SVM and FGM techniques to complex genetic and proteomic data. Biomarkers are biological indicators or genetic expression signatures of certain disease states. Our intellectual property is protected by more than 90 patents that have been issued or are currently pending around the world.
Our business model has evolved over time to respond to business trends that intersect with our technological expertise and our capacity to professionally manage these opportunities. We initially sought only to use our SVMs internally in order to discover and license our biomarker signatures to various diagnostic and pharmaceutical companies. Today, our commercialization efforts include: utilization of our discoveries and knowledge to help develop diagnostic and prognostic predictive tests; licensure of the SVM and FGM technologies directly to diagnostic companies; and, the formation of new ventures with domain experts in other fields where our pattern recognition technology holds commercial promise.
Operational Activities
The Company markets its technology and related developmental expertise to prospects in the healthcare, biotech, and life sciences industries. Given the scope of some of these prospects, the sales cycle can be quite long, but management believes that these marketing efforts may produce favorable results in the future.
NeoGenomics License
On January 6, 2012, we entered into a Master License Agreement (the “NeoGenomics License”) with NeoGenomics Laboratories, Inc. (“NeoGenomics Laboratories”), a wholly-owned subsidiary of NeoGenomics, Inc. (“NeoGenomics”). Pursuant to the terms of the NeoGenomics License, we granted to NeoGenomics Laboratories and its affiliates an exclusive worldwide license to certain of our patents and know-how to use, develop and sell products in the fields of laboratory testing, molecular diagnostics, clinical pathology, anatomic pathology and digital image analysis (excluding non-pathology-related radiologic and photographic image analysis) relating to the development, marketing production or sale of any “Laboratory Developed Tests” or LDTs or other products used for diagnosing, ruling out, predicting a response to treatment, and/or monitoring treatment of any or all hematopoietic and solid tumor cancers excluding cancers affecting the retina and breast cancer. We retain all rights to in-vitro diagnostic (IVD) test kit development.
HEALTH DISCOVERY CORPORATION
Management’s Discussion and Analysis, continued
Upon execution of the NeoGenomics License, NeoGenomics Laboratories paid us $1,000,000 in cash and NeoGenomics issued to us 1,360,000 shares of NeoGenomic’s common stock, par value $0.001 per share, which had a market value of $1,945,000 using the closing price of $1.43 per share for NeoGenomic’s common stock on the OTC Bulletin Board on January 6, 2012. In addition, the NeoGenomics License provides for milestone payments in cash or stock, based on sublicensing revenue and revenue generated from products and services developed as a result of the NeoGenomics License. Milestone payments would be in increments of $500,000 for every $2,000,000 in GAAP revenue recognized by NeoGenomics Laboratories up to a total of $5,000,000 in potential milestone payments. After $20,000,000 in cumulative GAAP revenue has been recognized by NeoGenomics Laboratories, we will receive a royalty of (i) 6.5% (subject to adjustment under certain circumstances) on net revenue generated from all Licensed Uses except for the Cytogenetics Interpretation System and the Flow Cytometry Interpretation System and (ii) a royalty of 50% of net revenue (after the recoupment of certain development and commercialization costs) that NeoGenomics Laboratories derives from any sublicensing arrangements it may put in place for the Cytogenetics Interpretation System and the Flow Cytometry Interpretation System.
NeoGenomics Laboratories agreed to use it best efforts to commercialize certain products within one year of the date of the license, subject to two one-year extensions per product if needed, including a “Plasma Prostate Cancer Test”, a “Pancreatic Cancer Test”, a “Colon Cancer Test”, a “Cytogenetics Interpretation System”, and a “Flow Cytometry Interpretation System.” In January 2013, NeoGenomics informed the Company of its intent to continue under the terms of the license and therefore extend the license for the first of its one-year extensions.
If NeoGenomics Laboratories has not generated $5.0 million of net revenue from products, services and sublicensing arrangements within five years, we may, at our option, revoke the exclusivity with respect to any one or more of the initial licensed products, subject to certain conditions.
The Company believes our relationship with NeoGenomics is instrumental in our medical and diagnostic testing development. We further believe the majority, if not all, of our applications in the medical field will be done in conjunction with the NeoGenomics License.
Plasma Test for Prostate Cancer
NeoGenomics is developing a Blood Test for Prostate Cancer under the direction of Dr. Maher Albitar using the genes patented by HDC. NeoGenomics recently announced that a publication has been submitted for the test and expects a launch of this test in the first half of 2014.
Cytogenetic Analysis
Cytogenetic analysis is the science of studying chromosomes. Microscopic evaluation of individual chromosomes remains the first step in the evaluation of the human genome. Cytogenetic analysis is performed on almost all patients with hematopoietic diseases (blood cancers such as leukemia and lymphoma) and on a significant number of patients with solid tumors. The collected data is useful for diagnosis, prognosis and monitoring of diseases. Currently most of the analysis is performed manually by specially trained technicians. The work is labor-intensive and subjective. Computer automation of this work could significantly reduce cost and improve the quality of the test.
NeoGenomics is currently working on development, validation and commercialization of this new image analysis tool for cytogenetic analysis under the direction of Dr. Maher Albitar.
Flow Cytometry
Management believes that our efforts to develop an SVM-based diagnostic test to help interpret flow cell cytometry data for myelodysplastic syndrome (pre-leukemia) has resulted in a successful proof of concept. The Company, along with NeoGenomics, is now capable of completing development, final validation and commercialization of the new diagnostic test for the interpretation of flow cytometry data. This test has been licensed to NeoGenomics for final development.
HEALTH DISCOVERY CORPORATION
Management’s Discussion and Analysis, continued
SVM Capital, LLC
In January 2007, SVM Capital, LLC (“SVM Capital”) was formed as a joint venture between HDC and Atlantic Alpha Strategies, LLC (“Atlantic Alpha”) to explore and exploit the potential applicability of our SVM technology to quantitative investment management techniques. Atlantic Alpha’s management has over thirty years of experience in commodity and futures trading. Atlantic Alpha reports that the SVM technology is now working well in two distinct investment areas.
First, it is being applied to price data. Utilizing open, high, close, low and volume SVM utilizes an 85 dimensional space to make future predictions. This price driven model is using fifty exchange traded funds (ETFs) which give it a global perspective. Much testing and refinement of this model has been accomplished and is being used for trading by Atlantic Alpha.
Second,
Atlantic Alpha is applying SVM technology to quarterly fundamental corporate data such as sales, earning and projected
earnings. SVM technology is utilized to separate stocks that should outperform and underperform in the next
quarter based on current data.
The Company is actively marketing the SVM Capital product to potential institutional users of the technology. An example of this effort is the recent partnership SVM Capital formed with Lucena Research, LLC (“Lucena”) to further develop and commercialize the technology in the field of financial markets. This transaction allows for SVM Capital to recognize eighty percent of the revenue generated from the SVM improved products offered by Lucena.
Retinalyze
In early 2012, Retinalyze, LLC, a joint venture of which the Company owns fifty percent, launched Retinalytics SVM
TM
, to assist Ophthalmologists and Optometrists in the Detection of Macular Degeneration. While the first Retinalytics SVM
TM
product released focuses on age-related macular degeneration, the Company continues to improve the service and also develop a second product using fundoscopic images of retinal vessels to assist eye care professionals in the detection of Alzheimer’s disease.
The
volume of images processed thus far have been significantly less than expected and revenues to date from Retinalytics
SVM
TM
have been negligible. The Company
continues to evaluate options to improve the product with the goal of solving this slower than expected adoption issue,
thereby allowing the analysis of a higher volume of scans. In addition, the Company is evaluating all options related to the
product, along with the existing partnership, with the goal of optimal commercialization of this technology.
Intellectual Property Developments
Currently, the Company holds the exclusive rights to 62 issued U.S. and foreign patents covering uses of SVM and FGM technology for discovery of knowledge from large data sets. Two new U.S. patents were granted during the 3
rd
Quarter of 2013, including Patent No. 8,489,531, relating to cluster analysis of gene expression data, and Patent No. 8,463,718, for a SVM-based method for analysis of spectral data. New continuation applications were filed prior to issue of the new patents. In addition, new U.S. and international applications were filed covering the company’s latest developments in computer-assisted karyotyping using SVMs. With these new applications, the Company has 21 pending U.S. and foreign patent applications covering uses of the SVM technology as well as biomarkers and diagnostic methods that have been discovered using the SVM technology. The reduction in the total number of issued and pending patents during the past year resulted from the Company’s decision to allow certain foreign patents issued and/or filed in countries that were deemed to have lower strategic value to lapse. This in turn reduced the Company’s total expenses for patent maintenance.
HEALTH DISCOVERY CORPORATION
Management’s Discussion and Analysis, continued
Intel
In October 2012,
the US Patent and Trademark Office (“USPTO”) issued a reexamination certificate for Intel’s U.S. Patent No. 7,685,077,
which issued in 2010 with claims covering SVM-RFE. The reexamination certificate confirms the patentability of the claims as amended
during the reexamination proceedings. The Company submitted a request to the USPTO to initiate interference proceedings once
the reexamination certificate was issued and subsequently received a final rejection in the application that was filed to provoke
the interference. A response referring to these decisions has been submitted to the USPTO, but the USPTO has yet to act on this
response.
Three Months Ended June 30, 2013 Compared with Three Months Ended June 30, 2012
Revenue
For the three months ended June 30, 2013, revenue was $256,560 compared with $276,437 for the three months ended June 30, 2012. The revenue earned during the second quarter of 2013 and 2012 is primarily related to the licensing revenue recognition for the NeoGenomics License.
Operating and Other Expenses
Amortization expense was $65,680 for both the three months ended June 30, 2013 and 2012. Amortization expense relates primarily to the costs associated with filing patent applications and acquiring rights to the patents.
Professional and consulting fees totaled $219,322 for the three months ended June 30, 2013, compared with $122,710 for the same 2012 period. The increase is due primarily to former employees converting to consultants and the hiring of an additional consultant.
Legal
fees increased over the three month period with fees totaling totaled $46,801 during the three months ended June 30, 2013 and
$33,518 during the same period in 2012. The increase in legal fees primarily relates to legal issues in connection with
management changes.
Research and development expense was $23,678 for the three months ended June 30, 2013, and $37,220 for the same period in 2012. This reduction in expense for research and development is related primarily to work completed under the Retinalyze, LLC launch in 2012, which did not recur in 2013.
Compensation expense of $158,009 for the three months ended June 30, 2013 was lower than the $368,331 reported for the comparable 2012 period. The decrease is attributed to the conversion of certain employees to consultants.
Other general and administrative expense decreased to $178,534 for the three months ended June 30, 2013, compared to $190,050, for the same period in 2012. This decrease was due to the elimination of expenses related to investor relation charges, and by reduced travel expenses.
Loss from Operations
The loss from operations for the three months ended June 30, 2013 was $435,464, compared to $541,072 for the three months ended June 30, 2012. This reduction was due to lower costs primarily associated with compensation and other general and administrative expenses.
Other Income and Expense
The
Company received a portion of the NeoGenomics license fee in NeoGenomics stock in January 2012. The Company has chosen to measure
the gain or loss on the value of this asset using the fair value option method. During the three month period
ending June 30, 2013, the change in the NeoGenomics stock fair value decreased by $3,930, which is recorded as other expense
in the statements of operations. During the same three month period in 2012, the change in the NeoGenomics stock
fair value increased by $13,600.
There was no interest income for the three months ended June 30, 2013, compared to $212 in 2012. Interest income decreased because the Company had less cash on hand to invest throughout the 2013 period.
HEALTH DISCOVERY CORPORATION
Management’s Discussion and Analysis, continued
Net Loss
The net loss for the three months ended June 30, 2013 was $439,394, compared to a loss of $527,260 for the three months ended June 30, 2012. The change was due primarily to decreased operating expenses.
The loss attributable to common shareholders was $473,774 for the three months ended June 30, 2013 compared to a loss of $561,845 in the three months ended June 30, 2012. The change is related to lower expenses related to the Company’s attempt to control costs.
Loss
per share was $0.002 for both the three month period ended June 30, 2013 and for the quarterly period ended June 30, 2012.
Six Months Ended June 30, 2013 Compared with Six Months Ended June 30, 2012
Revenue
For the six months ended June 30, 2013, revenue was $540,699 compared with $562,066 for the six months ended June 30, 2012. Revenue is recognized for licensing and development fees over the period earned. The revenue earned is almost entirely related to the licensing revenue recognition for the NeoGenomics License.
Operating and Other Expenses
Amortization expense was $131,360 for both the six months ended June 30, 2013 and 2012. Amortization expense relates primarily to the costs associated with filing patent application and acquiring rights to the patents.
Professional and consulting fees were $498,404 for the six months ended June 30, 2013 compared with $341,469 for the same 2012 period. The increase is due primarily to former employees converting to consultants and the hiring of an additional consultant.
Legal fees totaled $85,956 during the six months ended June 30, 2013 compared to $64,691 during the same period in 2012. The increase in legal fees primarily relates to legal issues in connection with management changes.
Research and Development fees were $58,829 for the six months ended June 30, 2013 and $73,150 for the same period in 2012. This decrease relates primarily to the completion of work related to the launch of the Retinalyze product.
Compensation expense of $324,035 for the six months ended June 30, 2013 was less than the $659,148 reported for the comparable 2012 period. Compensation was reduced as several employees converted to consultant status instead of employees.
Other
general and administrative expenses decreased to $292,867 for six months ended June 30, 2013 compared to $449,086 in
2012. This reduction was due to a one-time bonus for a business development consultant in 2012, the elimination of
investor relation fees, and less travel to investor trade shows.
Loss from Operations
The loss from operations for the six months ended June 30, 2013 was $850,752 compared to $1,156,838 for the period ended June 30, 2012. This reduction in loss from operations was due to lower general and administration costs.
Other Income and Expense
The Company received a portion of the NeoGenomics license fee in NeoGenomics stock. The Company has chosen to measure the gain or loss on the value of this asset using the fair value option method. During the six month period ending June 30, 2013, the NeoGenomics stock fair value increased by $726,170, which is recorded as other income in the statements of operations. During the same period in 2012, the NeoGenomics stock increased by 367,200.
HEALTH DISCOVERY CORPORATION
Management’s Discussion and Analysis, continued
There
was no interest income during the six month period ended June 30, 2013 compared to $992 for the six months ended June 30,
2012. Interest income decreased because the Company had less cash on hand to invest throughout the 2013
period.
Net Loss
The net loss for the six months ended June 30, 2013 was $124,582 compared to $788,646 for the six months ended June 30, 2012. The decreased net loss was due to lower operating expenses and the increased gains recognized on NeoGenomics Stock.
The net loss attributable to common shareholders was $193,167 for the six months ended June 30, 2013 compared to $1,208,078 in the six months ended June 30, 2012.
Net loss per share was $0.001 for the six month period ended June 30, 2013 and $0.005 for the six month period ended June 30, 2012.
Liquidity and Capital Resources
Our ability to continue as a going concern is dependent upon our licensing arrangements with third parties, achieving profitable operations, obtaining additional financing and successfully bringing our technologies to the market. The outcome of these matters cannot be predicted at this time. Our financial statements have been prepared on a going concern basis and do not include any adjustments to the amounts and classifications of the assets and liabilities that might be necessary should we be unable to continue in business.
If the going concern assumption was not appropriate for our financial statements then adjustments would be necessary in the carrying value of assets and liabilities, the reported expenses and the balance sheet classifications used. Such adjustments may be material.
At
June 30, 2013, the Company had $21,574 in cash and cash equivalents and total current liabilities of
$1,221,837. The primary amount of current liabilities relates to $1,024,988 in deferred revenue. Additionally, we
continue to sell our NeoGenomics Stock in order to fund operations. Although the NeoGenomics Stock has increased in value
compared to the acquisition date, the number of shares and amount of cash we can generate from the sale of NeoGenomics Stock
is subject to fluctuating market and price conditions and the value of NeoGenomics stock has declined since June 30, 2013. As a result we do not believe we have sufficient resources to meet
all of our current obligations unless the Company is able to secure revenue via licensing activity or other forms of fund
raising either in the debt or equity markets. None of these options are definitive and there can be no assurances
the Company will be successful in these financing efforts.
As
previously disclosed, the Company has taken steps to reduce its expenditures in order to reduce the “burn rate”
of cash to approximately $185,000 per month. These steps included reducing expenses and allocating our remaining cash reserves for our operational requirements
at a reduced level. In addition, the recent changes in management mentioned in Note H –
Subsequent Events, will allow the monthly expenditures to be reduced further.
The Company has relied primarily on equity and debt financing for liquidity. The Company must increase revenues in order to generate sufficient cash to continue operations. The Company’s plan to have sufficient cash to support operations is comprised of selling its NeoGenomics Stock, generating revenue through licensing its significant patent portfolio, providing services related to those patents, and obtaining additional equity or debt financing. The Company has been unable to generate significant revenue, as further described above. As a result, the Company has implemented a cash conservation program.
The following table summarizes our contr
actual obligations.
|
|
Total
|
|
|
1 Year
Or Less
|
|
|
More Than
1 Year
|
|
Office Lease
|
|
$
|
10,080
|
|
|
$
|
10,080
|
|
|
$
|
-
|
|
Total
|
|
$
|
10,080
|
|
|
$
|
10,080
|
|
|
$
|
-
|
|
HEALTH DISCOVERY CORPORATION
Management’s Discussion and Analysis, continued
Off-Balance Sheet Arrangements
The Company has no off-balance sheet arrangements that provide financing, liquidity, market or credit risk support or involve leasing, hedging or research and development services for our business or other similar arrangements that may expose us to liability that is not expressly reflected in the financial statements.
Forward-Looking Statements
This Report contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 12E of the Securities Exchange Act of 1934, including or related to our future results, certain projections and business trends. Assumptions relating to forward-looking statements involve judgments with respect to, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond our control. When used in this Report, the words “estimate,” “project,” “intend,” “believe,” “expect” and similar expressions are intended to identify forward-looking statements. Although we believe that assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate, and we may not realize the results contemplated by the forward-looking statement. Management decisions are subjective in many respects and susceptible to interpretations and periodic revisions based on actual experience and business developments, the impact of which may cause us to alter our business strategy or capital expenditure plans that may, in turn, affect our results of operations. In light of the significant uncertainties inherent in the forward-looking information included in this Report, you should not regard the inclusion of such information as our representation that we will achieve any strategy, objective or other plans. The forward-looking statements contained in this Report speak only as of the date of this Report as stated on the front cover, and we have no obligation to update publicly or revise any of these forward-looking statements. These and other statements which are not historical facts are based largely on management’s current expectations and assumptions and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those contemplated by such forward-looking statements. These risks and uncertainties include, among others, the failure to successfully develop a profitable business, delays in identifying customers, and the inability to retain a significant number of customers, as well as the risks and uncertainties described in “Risk Factors” section to our Annual Report for the fiscal year ended December 31, 2012.