Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


FORM 10-K

 

 

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

 

For the fis cal year ended December 31, 201 7

 

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

Commission File No. 0-25203


 

OmniComm Systems, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

11-3349762

(State or other jurisdiction of incorporation or organization)

(I.R.S. Employer Identification No.)

2101 West Commercial Blvd, Suite 3500

F or t Lauderdale, FL 33309

(Address of principal executive offices)

  (954)473-1254

  (Registrant’s telephone number, including area code )

 

Securities registered pursuant to Section 12(b) of the Act:

None

 

Securities registered pursuant to Section 12(g) of the Act:

Common Stock, $0.001 par value per share

(Title of class)

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.   Yes  ☐   No  ☒

 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act.   Yes  ☐   No  ☒

 

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 12 months (or 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  ☒   No  ☐

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ☒   No  ☐

 

Indicate by check mark if disclosure of delinquent filers in response 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 amendment to this Form 10-K. ☐

 

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

Accelerated filer

Non-accelerated filer

 

(Do not check if a smaller reporting company)

 

 

 

Smaller reporting company

 

 

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.   ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes  ☐   No  ☒

 

State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked prices of such common equity, as of the last business day of the registrant ’s most recently completed second fiscal quarter.

 

Date

Non-Affiliate Voting Shares Outstanding

Aggregate Market

Value

June 30 , 2017

90,804,629

$19,977,018

 

Our common stock trades on the OTCQX Marketplace (OTCQX). Shares of voting stock held by each officer and director and by each person who owns 10% or more of the outstanding common stock have been excluded in that such person may be deemed to be affiliates. This determination of affiliate status is not necessarily a conclusive determination for other purposes. The registrant has no shares of non-voting common stock authorized or outstanding.

 

Indicate the number of shares outstanding of each of the registrant ’s classes of common stock, as of the latest practicable date.

 

Date

Class

Outstanding Shares

March 29 , 2018

Common Stock, $0.001 par value per share

150,209,472

 

DOCUMENTS INCORPORATED BY REFERENCE

 

Portions of the information to be set forth in our Proxy Statement to be filed by us pursuant to Regulation 14A relating to our 2018 Annual Meeting of Stockholders to be held on June 7, 2018 are incorporated by reference herein in response to Items 10, 11, 12, 13 and 14 of Part III of this Form 10-K.

 

 

 

OMNICOMM SYSTEMS, INC.

ANNUAL REPORT ON

FORM 10-K

FOR THE YEAR ENDED DECEMBER 31, 2017

 

Table of Contents

   

   

Page

   

Part I

   

   

   

   

Item 1.

Business

  4

   

   

   

Item 1A.

Risk Factors

   14

   

   

   

Item 1B.

Unresolved Staff Comments

  21

   

   

   

Item 2.

Properties

21

   

   

   

Item 3.

Legal Proceedings

22

 

 

 

Item 4.

Mine Safety Disclosures

22

   

   

   

   

Part II

   

   

   

   

Item 5.

Market for Registrant ’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

22

   

   

   

Item 6.

Selected Financial Data

22

   

   

   

Item 7.

Management ’s Discussion and Analysis of Financial Condition and Results of Operations

22

   

   

   

Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

33

   

   

   

Item 8.

Financial Statements and Supplementary Data

33

   

   

   

Item 9.

Changes in and Disagreements With Accountants on Accounting and Financial Disclosure

33

   

   

   

Item 9A.

Controls and Procedures

33

   

   

   

Item 9B.

Other Information

33

   

   

   

   

Part III

   

   

   

   

Item 10.

Directors, Executive Officers and Corporate Governance

34

   

   

   

Item 11.

Executive Compensation

34

   

   

   

Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

34

   

   

   

Item 13.

Certain Relationships and Related Transactions; and Director Independence

34

   

   

   

Item 14.

Principal Accounting Fees and Services

34

   

   

   

   

Part IV

   

   

   

   

Item 15.

Exhibits, Financial Statement Schedules

34

   

   

   

 

  Signatures

38

 

 

 

PART I

 

ITEM 1.           BUSINESS

 

This business section and other parts of this Annual Report on Form 10-K (“Annual Report”) contain forward-looking statements that involve risk and uncertainties.  Our actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those set forth in “Risk Factors”, “Management’s Discussion and Analysis of Financial Condition and Results of Operations and elsewhere in this Annual Report. Reference to “us , ” “we , ” “our , ” the “Company” means OmniComm Systems, Inc. ® and our wholly owned subsidiaries OmniComm USA, Inc., OmniComm Ltd., OmniComm Europe GmbH, OmniComm Spain S.L. and OmniComm Systems B.V.

 

Overview

 

OmniComm Systems, Inc. provides web-based electronic data capture (“EDC”) and eClinical (“eClinical”) software and services that streamline the clinical research process. Our EDC and eClinical software and service offerings (“eClinical Products” or “eClinical Solutions”) consist of TrialMaster ® , TrialOne ® , IRTMaster™, Promasys ®  and eClinical Suite™. Our eClinical Products are designed to allow clinical trial sponsors and investigative sites to easily and securely collect, validate, transmit and analyze clinical study data. Our eClinical Products are 21 CFR Part 11 compliant solutions and are designed to offer clinical trial sponsors the ability to conduct clinical trials under multiple platforms, with significant flexibility, ease-of-use and with complete control over collected data.

 

Our eClinical Products offer significant business benefits to our customers and are designed to help clinical trial sponsors more efficiently conduct their clinical trials.  This efficiency can translate into more rapid initiation of data collection, less cost incurred in the data collection process and the ability to make more timely Go/No-Go decisions. We also provide business process consulting services that focus on more effectively integrating EDC and the broader array of eClinical Solutions and processes into the clinical trial process. Our goal is to provide our clients a data collection process that is streamlined, efficient and cost-effective.

 

The benefits of managing a clinical trial using our eClinical Products include:

 

 

Real-time access to the data

 

Faster study completion

 

Cost savings

 

Improved quality and visibility of results

 

Comprehensive clinical development solutions

 

Our Strategy

 

Our primary goal is to establish ourselves as a leading EDC and eClinical software and services provider by offering our customers the highest quality service with a differentiated, user-friendly product. We continually increase the scope and quality of the products and services we offer.  During 2017 we continued to update our products and increase their functionality to offer new solutions to our clients’ challenges. 

 

Key facets of our strategy include:

 

 

Scope Expansion. We plan to continue expanding the scope of services and products offered within the eClinical product spectrum via organic product and service development, through strategic partnerships and relationships and through the selective use of acquisitions;

 

 

Customer Base Expansion.  We will seek to expand the customer base for our existing set of eClinical Solutions and intend to design complementary solutions that will allow us to expand the universe of clients that we service; and

 

 

Diversification.  We intend to continue to diversify our revenue and customer base in order to avoid over-concentration of our business on any solution/product set or client-base.

 

 

Our Business Model

 

The scope of client clinical trial support service needs can vary from trial to trial.  Experience with EDC and other eClinical trial management solutions can also vary based on such factors as client size and sophistication.  Our approach to satisfying the diverse needs of our customers is to offer a variety of EDC solutions.  We offer our eClinical Products under an application service provider (“ASP”) business model as well as technology transition (“Technology Transition”) and technology transfer (“Technology Transfer”) business models (both of which are considered licensed).

 

We offer a fully hosted Technology Transition model designed to allow the client to bring study administration and set-up services in-house yet continue to host the solution with us, as well as a complete Technology Transfer model for clients that want to keep their eClinical technology solution completely in-house. This methodology allows our customers to use our services at their own pace, given the logistics of their human resource, infrastructure and capital constraints. This model allows us the flexibility to deliver eClinical solutions to a broader array of clinical trial sponsors.

 

Our Software Products and Services

 

TrialMaster Electronic Data Capture

 

Our core product is TrialMaster, which allows organizations conducting clinical trials to collect and manage their clinical trial data over the internet. Users at investigative sites such as hospitals and doctors ’ offices can enter data into electronic forms that represent the study protocol, and the data is immediately validated against a set of protocol-specific rules. Sponsor companies and Contract Research Organizations ("CROs") can then perform various data management and monitoring functions, such as comparing the entered data against source documents at the site. When all patient data has been entered, signed and locked, the sponsor company can extract the data for final analysis and produce PDFs of the source data ready for regulatory submission and site archive.

 

While there are many EDC products on the market, OmniComm believes that the breadth of functionality, ease of use and sophistication of implementation puts TrialMaster in a very strong position. The functionality of TrialMaster includes the following:

 

 

A highly productive tool for designing trials, featuring a drag-and-drop interface; a sophisticated JavaScript-based engine for building edit checks; and a tool for configuring how the data is to be exported;
 

A fine-grained security model that allows appropriate privileges to be granted to each user and role;

 

An online eLearning system that can be used to ensure users receive the appropriate training and pass all related assessments before being allowed to perform activities in TrialMaster;

 

A data entry sub-system that responds at the keystroke level to guide the user to enter correct data the first time. For example, if an adverse event is marked as “continuing”, it is impossible to also enter a stop date;

 

The ability to import external data through a file import utility;

 

Task lists and reports that support data entry and data cleaning processes, as well as adhoc reports and “data grids” that provide customizable access to the protocol-specific clinical data;

 

Support for Risk Based Monitoring, including a sophisticated mechanism to select a subset of data for Source Document Verification, based on risk factors for both the site and the patient;

 

The ability to detect Serious Adverse Events and construct Safety Cases that can subsequently be passed electronically to a full safety reporting system using the industry standard E2B message format;
 

The ability to translate both the TrialMaster application and all protocol text into any number of foreign languages, such that data can be entered in one language and reviewed in another;

 

The ability to allow patients to enter their own data, such as for electronic diaries, avoiding the need for a costly and separate system for electronic Patient Reported Outcomes;

  The ability to automatically produce data exports in the FDA-mandated SDTM format. We believe TrialMaster is the only EDC system with this capability; and
 

Application Programing Interfaces (APIs), that allow partner software products to fetch and update data in TrialMaster. The APIs follow the Operational Data Model standard maintained by the Clinical Data Interchange Standards Consortium (CDISC).  

 

In Q2 2018, OmniComm is scheduling a major new release of TrialMaster with a modern user interface and built-in support for mobile devices. This will allow TrialMaster to be accessed from a web browser or a tablet such as an iPad. The patient data entry module can be accessed using a smartphone such as an iPhone. Using “liquid layout” technologies, the TrialMaster display will automatically adjust to the form factor of the device on which it i s running.

 

 

 

TrialOne Phase I Clinic Automation

 

TrialOne is a comprehensive software application suite that provides clinical trial site sponsors, study investigators and study monitors with several tools designed to make the overall Phase I clinic operation more efficient.   Phase I studies are used to conduct the first tests of new drugs or medical devices in humans. They are often held in dedicated Phase I clinics, where volunteers follow a strict timed schedule of dosing followed by measurements such as vital signs, electrocardiograms and repeated blood draws. TrialOne is designed to manage the automation of Phase I clinics. It allows the specification of the schedule and the corresponding dosing and required measurements, then supports the real-time collection of data according to that schedule. Much of the data collection is automated via direct entry from instruments (eSource), such as barcode scanners that read barcodes on both the patients and the vials of blood being filled.

 

The key components of  TrialOne include:

 

Subject Recruitment and Screening

The TrialOne subject recruitment module is designed to provide essential functionality for automating the collection and tracking of information involved in finding, screening and scheduling subject candidates for an early phase study.   The customized database can be searched for volunteers based on specific demographics, medical history and concomitant medications.  Trial sponsors can define study-specific screening test panels and record volunteer screening test results.  Outbound communications can be managed allowing for the scheduling of calls, sending e-mail blasts, printing mailing labels or exporting flexible CSV files.

 

Scheduler

The Scheduler module provides a mechanism for defining the study structure including a time and events schedule.   The module is designed to optimize study build times using a wizard-driven design tool creating database efficiencies using object libraries and templates.   This can quickly produce clear, easy to use, schedule driven electronic case report forms ("CRFs") suitable for complex and adaptive clinical trials including study alarms and real time validation criteria with edits.  Additionally, the Scheduler can define actions or events to be automatically offset relative to the study drug and rapidly address mid-study changes.

 

Sample Tracking

TrialOne allows customers to completely automate their site ’s laboratory. Samples can be tracked and batched while alarms and information can be configured specific to each sample. Dispatch lists and labels are automatically produced for shipment of samples to the central laboratory. Data is then received back electronically into the TrialOne database.

 

Direct Data Capture (“DDC”)  

The DDC module allows capture of real-time data for screening or study at data collection stations, bed-side or roaming.   The system allows for the collection of data online, over an intranet or the internet using a desktop, notebook, or tablet PC.  Using a library of custom drivers the DDC module can collect vital signs or other biologic data directly from devices and/or instrumentation.  As with later phase applications the system can clean data at the point of collection with real-time validation edit checks while enhancing protocol compliance via schedule-driven workflows.  Working with the Subject Recruitment and Screening module the system seamlessly maps data to the recruitment database for future criteria searches.  Automation and authentication checks are maintained using a full array of barcode and scanner support for all aspects of the clinic including subject IDs, sample labeling and event tracking.

 

Ad Hoc Reporting

An integrated Ad Hoc reporting tool is available with wizard-driven report generation with drill-down reports that include interactive charts and graphs.   The Ad Hoc module supports aggregate data and advanced calculations, an advanced and easy to use export feature and distributable system reports by configurable schedules.  Data is protected by event configurable security and role-based security.  The Ad Hoc module allows for real-time data access to important trends such as vital signs and adverse events.

 

AutoEncoder

OmniComm ’s AutoEncoder provides a mechanism to turn free-text descriptions of adverse events and medications into coded entries from industry-standard dictionaries, namely MedDRA® for adverse events and WHO Drug® for medications. The product includes automated selection of proposed codes based on pattern matching against verbatim terms, automated management and use of history records to ensure coding consistency within a trial, an optional review and approval step and the transmission of coded results back to TrialMaster where they are stored as derived data values. The majority of TrialMaster trials use AutoEncoder.

 

In Q2 2018, OmniComm is scheduling a major new release of AutoEncoder with a modern user interface and enhanced functionality. This includes more sophisticated coding algorithms, the ability to manage history matches across a group of trials in a drug program, as well as the ability to load external synonym lists. This new version of AutoEncoder will work with both the current TrialMaster release and the upcoming TrialMaster new release as well as providing a full suite of APIs that will allow the system to work independently of TrialMaster.

 

IRTMaster

 

IRTMaster  is a new offering from OmniComm that provides “Interactive Response Technology” in support of the randomization process in clinical trials. The product allows the setup of trial parameters, such as the different strata for the patient population, then provides sophisticated randomization algorithms to randomize patients across the different treatment groups (such as the investigational medication and placebo). The algorithms include a minimization technique that prevents any significant imbalance across the different treatment groups. For example, in a block of ten patients where five will get the investigational medication and five will get placebo, there is a statistically significant chance that the first five patients will all get placebo; with a minimization algorithm, the chance of such an imbalance is significantly smaller.

 

IRTMaster can be used standalone through its user interface, or can interact with TrialMaster or any external system using API calls. In this mode, it can effectively be considered a “black box” application.

 

The initial release of IRTMaster supports various configuration options as well as randomization and related functions, such as emergency unblinding. A release planned for 2019 will add clinical supplies tracking and thereby complete the functionality.

 

Legacy Products

OmniComm provides two legacy products that have active support-paying customers, but are no longer being actively marketed.

 

The eClinical Suite provides a set of tools for collecting and managing clinical data, including EDC for real-time entry and double data entry ("DDE") for entry from paper originals. It also provides a central system for clinical trials management and another for adverse event reporting. AutoEncoder described above is part of the eClinical Suite and can be used against data collected either in eClinical Suite or in TrialMaster. OmniComm has announced the end of support for the eClinical Suite to be April 30 , 2019.

 

Promasys is a clinical trial data management system for both DDE and EDC that is primarily used at research institutions for investigator-initiated trials. It includes an iPad module for convenient data capture within the clinic and a separate ePRO module.

 

 

Hosting

 

Our customers rely on our eClinical Products to run their clinical trials and, as a result, we need to ensure the availability of our services. We have developed our infrastructure with the goal of achieving availability of our services, which are hosted on a highly-scalable network located in secure third-party co-location data center facilities. We host our eClinical Products ’ services and serve our customers primarily from a Cincinnati, Ohio co-location data center facility operated by and in conjunction with co-location services from CyrusOne, Inc. This co-location, consisting of 230 square feet, is specifically designed to optimize the delivery of our application services and to ensure the availability and security of our customers’ research data. The co-location data facility includes 24 by 7 staffing, enterprise class security, redundant power and cooling systems, large-scale data back-up capabilities and multiple Internet access points and providers.  In addition, we maintain a co-location facility in Fort Lauderdale, Florida which also serves as a back-up facility for purposes of disaster recovery, and a co-location facility in Frankfurt, Germany.  

 

Our hosting operations incorporate industry-standard hardware, databases and application servers in a flexible, scalable architecture. Elements of our hosting infrastructure can be replaced or added with minimal interruption in service in order to reduce the likelihood that the failure of any single device will cause a broad service outage. Our hosting architecture enables us to scale to increasing numbers of customers by adding additional capacity in the form of servers and disk space. Our storage architecture helps to ensure the safe, secure archiving of customers ’ data and to deliver the speed and performance required to enable customers to access and manage their clinical study data in real-time.

 

Support

 

We have a multi-national organization to support our applications worldwide. We offer 24 by 7 support to our customers and their investigator sites through multi-lingual help desks located in our Fort Lauderdale, FL and Bonn, Germany offices.

 

Consulting and Professional Services

 

Our services include hosting solutions, consulting services, customer support, training and the delivery of implementation services for Technology Transfer engagements, including installation, configuration, validation and training. The primary consulting services we offer include:

 

 

Project Management . We assign a project manager to oversee every project and provide up-to-date communications on the status of the project.

 

 

Clinical Services . We have expertise in translating a clinical protocol into an electronic CRF format.  We ensure that CRF design, visit schedule, site and patient definitions, edit checks, derivations and code lists are all optimized to use industry best practices, and, where applicable, CDISC/CDASH standards.

 

 

Training. We provide extensive hands-on and eLearning-based EDC training classes.  Training classes can be conducted at a sponsor location, at an investigator meeting or an investigator site and via web-cast.

 

 

Custom Configuration.   Our EDC and eClinical platforms are flexible and allow for major reconfiguration.  Each trial can be designed to suit the specific client workflows and trial design.  Our eClinical Products include a clinical trial management system (“CTMS”), drug supply, safety and randomization options that can simplify the trial management experience.

 

 

System Integration.  We help our clients integrate our EDC Solutions with existing systems or external systems (Patient Diaries, Medical Devices and Labs, etc.).  We analyze the client’s legacy systems and data management needs in order to decide how to most efficiently integrate EDC.

 

 

SOPs and implementation assistance.   Our client services and support personnel can be engaged to write an implementation plan designed to effectively integrate with our EDC Solutions.  We can also write standard operating procedures (“SOPs”) to help client staff clearly understand their roles in using our eClinical Products to conduct trial activities.  We can also analyze and document business processes to determine where greater operating efficiency may be gained.

 

 

Installation.   There are various architectures for deploying a secure EDC solution to remote investigator sites. These services explore different security, performance and system management alternatives and help the client design and install an optimal solution to meet their unique needs.

 

 

Validation.   We offer test kits that include test cases and documentation to validate the installation of our EDC applications against regulatory requirements.

   

 

Market Opportunity

 

Clinical trials are a critical component in bringing a drug or medical device to market.   All prescription drug and medical device therapies must undergo extensive testing as part of the regulatory approval process.  We believe many clinical trials continue to be conducted in an antiquated manner and fail to optimize the resources available for a successful clinical trial.  We believe that our solutions significantly reduce costs, improve data quality and expedite results.  We believe the data integrity, system reliability, management control and auditable quality of our eClinical Solutions will aid clinical trial sponsors that want to improve clinical trial efficiencies, speed-up results and ensure regulatory compliance.

 

We believe that success in the EDC market is predicated on several criteria.   As the industry grows and matures the ability of participants to fulfill the varied needs of clinical trial sponsors becomes more critical to achieving operational and financial success.  We believe these success criteria include:

 

 

Deployment options.   Successful EDC vendors provide clinical trial sponsors with flexibility in choosing whether to deploy EDC on an ASP, Technology Transfer or Technology Transition basis.  The ultimate criteria for the selection of the type of technology delivery methodology is often predicated on the size and the resources of the clinical trial sponsor.

 

 

Interoperability.   Most clinical trial sponsors have invested in other technology platforms to run their trials.  These include clinical data management systems, interactive voice response systems and central labs.  The ability for an eClinical solution to integrate with existing technology platforms is a key decision making factor.

 

 

Scalability.   The ability to scale the eClinical solutions to absorb additional projects seamlessly is important to trial sponsors.  Scalable solutions will retain their speed and performance metrics as projects and engagements increase in size.

 

 

Migration from hosted to technology transfer solutions.   When clinical trial sponsors decide to bring the eClinical services and solutions in-house it is vital that they do not experience a degradation of speed, performance or system reliability.

 

 

Flexibility.   The more robust eClinical systems will be designed to provide the ability to increase functionality and guarantee interoperability with other industry technology solutions.  As the industry and technology matures clinical trial sponsors will demand new functionality without loss of performance or reliability.

 

 

Systematic adoption of best practices .  eClinical vendors will be expected to assimilate best-practice workflows and process tools.

 

 

Professional services.    The adoption and implementation of eClinical solutions into a clinical trial environment requires significant financial, technical and human resource investment on the part of clinical trial sponsors.  A robust offering of professional services that fully integrate with the technological eClinical offerings will be considered an integral part of any eClinical purchase.

 

License Agreement

 

DataSci, LLC

 

Effective April 2, 2009, we entered into a Settlement and Licensing Agreement with DataSci, LLC (“DataSci”) which relates to a lawsuit filed on June 18, 2008 in the United States District Court for the District of Maryland by DataSci against OmniComm alleging infringement of U.S. Patent No. 6,496,827 B2 entitled “Methods and Apparatus for the Centralized Collection and Validation of Geographically Distributed Clinical Study Data with Verification of Input Data to the Distributed System” (“Licensed Patent”) owned by DataSci. Pursuant to the Settlement and Licensing Agreement, the parties entered into a Stipulated Order of Dismissal of the lawsuit filed by DataSci and DataSci (i) granted us a worldwide, non-exclusive non-transferable right and license under the Licensed Patent the subject of the claim for the Licensed Products and the right to sublicense TrialMaster on a Technology Transfer and Technology Transition basis, and (ii) released us from any and all claims of infringement of the Licensed Patent which may have occurred prior to the effective date of the Settlement and Licensing Agreement. Licensed Products is defined as all products and services of OmniComm and of its subsidiaries in the field of electronic data capture, whether sold by OmniComm directly or through its affiliates, parents, subsidiaries, partners, vendors, agents and/or representatives, including TrialMaster products and services or other products and services that perform the substantially equivalent function of TrialMaster, and any other products and services that OmniComm may develop in the future in the field of electronic data capture. The license expressly excludes the right to make, use, sell, import, market, distribute, oversee the operation of, or service systems covered by a claim (if any) of the Licensed Patent to the extent such systems are used for creating and managing source documentation and conducting remote data validation in clinical trial studies using a tablet PC with stylus, touch screen device, digitizing tablet, digitizer pen or similar mobile processing device (“Digitizing Device”), wherein the source documentation is electronic and is completed using a Digitizing Device. Under the terms of the license, we were obligated to pay royalties quarterly for sales of Licensed Products from January 1, 2008 until December 31, 2017 in the amount of the greater of two percent (2%) of our annual gross revenues from Licensed Products or, alternatively, the annual minimum royalty payment(s). The Settlement and Licensing Agreement and the amendment thereto (described below) could be terminated on thirty (30) days’ notice by the licensor if we were in default on our obligations thereunder and failed to cure such default within the thirty (30) day period after notice is provided. In addition to the payment of royalties, the Settlement and Licensing Agreement imposed certain obligations on us including commercialization, certain sublicensing, other payments, insurance, and confidentiality. In addition and as a license fee for past use of the Licensed Patent which may have occurred prior to the effective date of the Settlement and Licensing Agreement, we issued a warrant to DataSci to purchase 1,000,000 shares of our common stock at an exercise price of $.01 per share.   The Settlement and Licensing Agreement provides that upon the expiration date of the warrant, at DataSci’s sole discretion, DataSci shall exercise its option under the warrant or licensee shall pay DataSci $300,000. The warrant was exercisable commencing on the second anniversary of the Settlement and Licensing Agreement, April 2, 2011, through the expiration date of the warrant on December 31, 2017. On December 31, 2017 DataSci exercised 50% of the warrant for 500,000 common shares and requested cash payment on 50% of the warrant. As a result, DataSci received 500,000 restricted common shares and a net cash payment of $145,000.

 

 

On June 23, 2009, we entered into an agreement to acquire the EDC assets of eResearch Technology.   Concurrent with the consummation of that transaction we entered into the First Amendment to Settlement and Licensing Agreement with DataSci, (i) to include the eResearch Technology EDC assets acquired within the definition of Licensed Products, and as such subject to the royalty payment(s), under and in accordance with the Settlement and Licensing Agreement, and (ii) provide a release by DataSci of any and all claims of infringement of the Licensed Patent in connection with the eResearch Technology EDC assets acquired which may have occurred prior to the effective date of the First Amendment to Settlement and Licensing Agreement for an aggregate amount of $300,000.

 

Our Customers

 

We are committed to developing long-term, partnering relationships with our clients and adapting our products and services to meet the unique and challenging needs of their trials. Our customers include leading pharmaceutical, biotechnology, medical device companies, academic institutions, CROs and other entities engaged in clinical trials. As of December 31, 2017, we had approximately 120 customers, including two of the top ten global pharmaceutical companies, five of the top ten CROs and two of the top biotechnology companies, measured by revenue. Our representative customers by sponsor type include:

 

Trial Sponsor

Sponsor Type

Eli Lilly

Pharmaceutical

Cromsource

Contract Research Organization

PPD

Contract Research Organization

Covance

Contract Research Organization

New York Medical Center

Academic

Saint Jude ’s Children’s Research Hospital

Medical research

ICON

Contract Research Organization

Pfizer

Pharmaceutical

 

Our top five customers accounted for approximately 36% of our revenues during the year ended December 31, 2017 and approximately 37% of our revenues during the year ended December 31, 2016.   One customer accounted for approximately 10% of our revenues during the year ended December 31, 2017.  One customer accounted for approximately 16% of our revenues during the year ended December 31, 2016.

 

Our international customers, principally located in Europe and East Asia, accounted for approximately 23% of our total revenues for the year  ended December 31, 2017 and 17% of our total revenues for the year ended December 31, 2016.

 

One customer accounted for approximately 24% and another customer accounted for approximately 10% of our accounts receivables as of December 31, 2017. Two customers each individually accounted for approximately 11% of our accounts receivables as of December 31, 2016. 

 

Sales and Marketing

 

We sell our products through a direct sales force, relationships with CRO Partners, and through co-marketing agreements with Vendor and Channel Partners.  Our marketing efforts to-date have focused on increasing market awareness of our Company and eClinical Products.  These efforts have primarily been comprised of attendance and participation in industry conferences and seminars.  A primary focus of our future marketing efforts will be to continue increasing our market penetration and market awareness.  As of December 31, 2017, we had 22 full-time employees and consultants in sales and marketing.

 

 

Our efforts during 201 8 will include increasing the number of sales personnel and sales support staff employed in the United States, Europe and East Asia, increasing our attendance and marketing efforts at industry conferences and increasing the number of Company sponsored events including webinars, symposiums and other marketing events. 

 

Clinical trial sponsors have historically outsourced many of their clinical research activities in an attempt to control costs and expand capacity. Our CRO relationships help us position our software solutions as the core platform for their outsourced client trial management services. Through our CRO Preferred Program, we partner with CROs to deliver our eClinical Solutions along with the CRO’s project and data management expertise. We also train, certify and support our CRO and other clinical services partners, which enables them to quickly and cost-effectively implement our technology in sponsors’ studies.  A critical aspect of the program is our ability to deliver our eClinical Solutions on a fixed cost basis to our partners.  Because of the economics intrinsic to the CRO industry, a fixed cost solution affords the partner a stronger ability to manage their costs and deliver cost-effective solutions to their clinical trial sponsor clients.

 

We have been able to obtain valuable insight into our customers ’ needs through the following customer specific initiatives:

 

Innovation Forum: The goal of the Innovation Forum is to ensure that attendees receive practical information, training and collaboration that can be taken back, implemented and shared within their respective organizations. The 2017 Innovation Forum attracted more than 100 attendees, along with the highest number of external thought leading and keynote speakers as well as the largest number of sponsoring and exhibiting partners. Content included product demonstrations, customer case studies, panel discussions, partner presentations and thought provoking presentations from independent industry thought leaders.

 

eClinical webinars:    We host periodic web-based seminars for current and prospective customers, which are typically focused on our products or current developments in the eClinical industry.  These webinars offer informative industry related topics to our customers and foster good relationships with our current and potential customers.

 

Product Development

 

The Company focuses on maintaining high quality product development standards. Product development activities include research and the development of platform and/or client specific software enhancements such as adding functionality, improving usefulness, increasing responsiveness and adapting to newer software and hardware technologies.

 

The Company spent  $2,854,428 during the year ended December 31, 2017 and $2,598,962 during the year ended December 31, 2016 on product development initiatives. The Company’s product development efforts are focused on the continued enhancement and redesign of our eClinical Solutions to keep our technology at the cutting edge in the markets in which we compete.

 

Intellectual Property

 

Our success and ability to compete are dependent on our efforts to develop and maintain the proprietary aspects of our technology. We rely upon a combination of trademark, trade secret, copyright and unfair competition laws, as well as license agreements and other contractual provisions, to protect our intellectual property and other proprietary rights. In addition, we attempt to protect our intellectual property and proprietary information by requiring our employees and consultants to enter into confidentiality, non-competition and assignment of inventions agreements. We have registered trademarks and service marks in the United States and abroad, and have filed applications for the registration of additional trademarks and service marks. Our principal trademarks are “OmniComm Systems,” “TrialMaster,” “TrialBuilder,” “TrialExplorer,” OmniCloud,” “Promasys” and “TrialOne.”  These legal protections afford only limited protection for our technology. Our agreements with employees, consultants and others who participate in development activities could be breached.  However, due to rapid technological change, we believe that factors such as the technological and creative skills of our personnel, new product and service developments and enhancements to existing products and services are more important than the various legal protections of our technology to establish and maintain a technology leadership position.

 

We currently hold several domain names, including the domain names “omnicomm.com,” “promasyssoftware.nl,” “promasyssoftware.com” and “trialmaster.com.” Additionally, legislative proposals have been made by the U.S. federal government that would afford broad protection to owners of databases of information. The protection of databases already exists in the European Union. The adoption of legislation protecting database owners could have a material adverse effect on our business, requiring us to develop additional, complex data protection features for our software products.

 

 

Despite our efforts to protect our proprietary rights, unauthorized parties may attempt to copy aspects of our software solutions or to obtain and use information that we regard as proprietary. The laws of many countries do not protect our proprietary rights to as great an extent as do the laws of the United States. Litigation may be necessary in the future to enforce our intellectual property rights or to determine the validity and scope of the proprietary rights of others. Any such litigation could result in substantial costs and diversion of resources and could have a material adverse effect on our business, operating results or financial condition. There can be no assurance that our means of protecting our proprietary rights will be adequate or that our competitors will not independently develop similar technology. Any failure to meaningfully protect our intellectual property and other proprietary rights could have a material adverse effect on our business, operating results or financial condition.

   

In addition,   since the software and Internet-based industries are characterized by the existence of a large number of patents, trademarks and copyrights it also involves frequent litigation based on allegations of infringement or other violations of intellectual property rights. We, and other companies in our industry, have entered into a settlement and obtained a license from a patent holder (DataSci, LLC) to license third-party technology and other intellectual property rights that are incorporated into some elements of our services and solutions. Our technologies may not be able to withstand third-party claims or rights against their use. Any intellectual property claims against us, with or without merit, could be time-consuming and expensive to litigate or settle, could divert management attention from executing our business plan or require us to enter into royalty or licensing agreements with third parties. Such royalty or licensing agreements, if required, might not be available on terms acceptable to us or at all, which could have a material adverse effect upon our business and financial position. There is no assurance that we will not become subject to infringement claims as the number of products and competitors in our industry segment grows and the functionality of products in different industry segments overlaps. An adverse determination on such a claim would increase our costs and could also prevent us from offering our technologies and services to others.

 

We have licensed in the past, and expect that we may license in the future, certain of our proprietary rights, such as trademarks, technology or copyrighted material, to third parties. We generally provide in our customer agreements that we will indemnify our customers against third-party infringement claims relating to our technology provided to the customer.

 

Competition

 

The market for EDC, data management and interactive response technology systems is highly competitive, rapidly evolving, fragmented and is subject to changing technology, shifting customer needs and frequent introductions of new products and services. We compete with systems and paper-based processes utilized by existing or prospective customers, as well as other commercial vendors of EDC and eClinical applications, clinical data management systems and adverse event reporting software, including:

 

 

systems developed internally by existing or prospective customers;

 

vendors of EDC, eClinical,   clinical trial management systems and adverse event reporting product suites, including Oracle Clinical a business unit of Oracle Corporation and Medidata Solutions;

 

vendors of stand-alone EDC, data management and adverse event reporting products; and

 

CROs with internally developed EDC, clinical data management systems or adverse event reporting systems.

 

Our ability to remain competitive will depend to a great extent upon our ongoing performance in the areas of product development, customer support and service delivery. We believe that the principal competitive factors in our market include the following:

 

 

product functionality and breadth of integration among t he EDC, eClinical and interactive response technology solutions;

 

reputation and financial stability of the vendor;

 

low total cost of ownership and demonstrable benefits for customers;

 

depth of expertise and quality of consulting and training services;

 

performance, security, scalability, flexibility and reliability of the solutions;

 

speed and ease of implementation and integration; and

 

sales and marketing capabilities and the quality of customer support.

 

Government Regulation

 

The conduct of clinical trials is subject to regulation and regulatory guidance associated with the approval of new drugs, biological products and medical devices imposed upon the clinical trial process by the U.S.  federal government and related regulatory authorities such as the FDA and by foreign governments. Use of our software products, services and hosted solutions by entities engaged in clinical trials must be done in a manner that is compliant with these regulations and regulatory guidance. Failure to do so could have an adverse impact on a clinical trial sponsor’s ability to obtain regulatory approval of new drugs, biological products or medical devices. If our product and service offerings fail to allow our customers and potential customers to operate in a manner that is compliant with applicable regulations and regulatory guidance, clinical trial sponsors and other entities conducting clinical research may be unwilling to use our software products, services and hosted solutions. Accordingly, we design our product and service offerings to allow our customers and potential customers to operate in a manner that is compliant with applicable regulations and regulatory guidance. We also expend considerable time and effort monitoring regulatory developments that could impact the use of our products and services by our customers and use this information in designing or modifying our product and service offerings.

 

 

The following is an overview of some of the regulations that our customers and potential customers are required to comply with in the conduct of clinical trials.

 

The clinical testing of drugs, biologics and medical devices is subject to regulation by the FDA and other governmental authorities worldwide. The use of software during the clinical trial process must adhere to the regulations and regulatory guidance known as Good Clinical Practices, other various codified FDA regulations, the Consolidated Guidance for Industry from the International Conference on Harmonization regarding Good Clinical Practice for Europe, Japan and the United States and other guidance documents. Our products, services and hosted solutions are developed using our domain expertise and are designed to allow compliance with applicable rules or regulations.

 

In addition to the aforementioned regulations and regulatory guidance, the FDA has developed regulations and regulatory guidance concerning electronic records and electronic signatures. The regulations, codified as 21 CFR Part 11, are interpreted for clinical trials in a guidance document titled Computerized Systems Used in Clinical Investigations. This regulatory guidance stipulates that computerized systems used to capture or manage clinical trial data must meet certain standards for attributability, accuracy, retrievability, completeness, originality, traceability, inspectability, validity, security and dependability. Other guidance documents have been issued that also help in the interpretation of 21 CFR Part 11.

 

Regulation of the use and disclosure of personal medical information is complex and growing. Federal legislation in the United States, known as the Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes a number of requirements on the use and disclosure of "protected health information" which is individually identifiable, including standards for the use and disclosure by the health care facilities and providers who are involved in clinical trials. HIPAA also imposes on these healthcare facilities and providers standards to assure the confidentiality of health information stored or processed electronically, including a series of administrative, technical and physical security procedures. This may affect us in several ways. Many users of our products and services are directly regulated under HIPAA and, to the extent our products cannot be utilized in a manner that is consistent with the users' HIPAA compliance requirements, our products will likely not be selected. In addition, we may be directly affected by HIPAA and similar state, federal and foreign privacy laws. Under HIPAA, to the extent we perform functions or activities on behalf of customers that are directly regulated by such medical privacy laws, such customers may be required to obtain satisfactory assurance, in the form of a written agreement that we will comply with a number of the same HIPAA requirements.

 

In addition, we are subject to a number of U.S. federal and state and foreign laws and regulations that affect companies conducting business through the Internet. Many of these laws and regulations are still evolving and being tested in courts, and could be interpreted in ways that could harm our business. These may involve user privacy and data protection, rights of publicity, content, intellectual property, advertising, marketing, data security, data retention and deletion, personal information, electronic contracts and other communications, competition, telecommunications, product liability, taxation, economic or other trade prohibitions or sanctions and securities law compliance.

 

Background and History

 

OmniComm Systems, Inc. was originally organized as Coral Development Corp., under the laws of the State of Delaware, on November 19, 1996, by Modern Technology Corp. (“Modern”) for the purpose of combining with an existing privately held company and for  Modern to distribute Coral Development shares as a dividend to Modern shareholders.  On February 17, 1999, OmniComm Systems, Inc., a company organized under the laws of the State of Florida as the Premisys Group, Inc. on March 4, 1997, merged with Coral Development.  Coral Development was the surviving entity post-merger.  The merged entity changed its name to OmniComm Systems, Inc.

 

Employees

 

As of December 31, 2017, we employed 140 employees and consultants Company-wide as follows: 66 out of our headquarters in Fort Lauderdale, Florida, 9 out of a regional operating office in Somerset, New Jersey and 27 in remote locations throughout the United States and Canada.  Our wholly-owned subsidiary, OmniComm Europe, GmbH, employs 18 in Bonn, Germany.  Our wholly-owned subsidiary, OmniComm Ltd., employs 13 in Southampton, England.  Our wholly-owned subsidiary, OmniComm Spain, S. L. employs 2 in Barcelona, Spain.  Our wholly-owned subsidiary, OmniComm Systems B.V. employs 4 in Leiden, the Netherlands and 1 in Japan. We believe that relations with our employees are good.  None of our employees are represented by a collective bargaining agreement.

 

Available Information

 

Our Internet website address is http://www.omnicomm.com .  The information on or accessible through our website is not incorporated by reference in this Annual Report. Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other Securities and Exchange Commission filings, and any amendments to those reports and any other filings, filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 are available free of charge via a link on our website as soon as reasonably practicable after we electronically file the materials with the Securities and Exchange Commission or on the Securities and Exchange Commission website at  http://www.sec.gov .

 

 

ITEM 1A.   Risk Factors

RISK FACTORS

 

An investment in our securities is speculative in nature and involves a high degree of risk.   In addition to the other information contained in this Annual Report, our stockholders and prospective investors should carefully consider the following material risk factors in evaluating us and our business.

 

WE HAVE A HISTORY OF LOSSES , A LARGE ACCUMULATED DEFICIT AND ANTICIPATE FUTURE LOSSES. WE MAY BE  UNABLE TO ACHIEVE OR MAINTAIN PROFITABILITY IN THE FUTURE .

 

We have incurred significant losses since we began doing business. At December 31, 2017, we had an accumulated deficit of approximately $72,323,819 and a working capital deficit of approximately $6,462,136.  We expect our operating cash flows to improve in 2018, but we have little control over the timing of contracted projects.  We expect our client and contract base to expand and diversify to the point where it meets our on-going operating needs, but this may not happen. While we expect to achieve additional revenue through the growth of our business, we cannot assure you that we will generate sufficient revenue to fund our expenses and maintain profitability in any period.

 

OUR A BILITY TO CONDUCT OUR BUSINESS C OULD BE MATERIALLY AFFECTED IF WE WERE UNABLE TO REPAY OR EXTEND THE MATURITY DATES OF OUR OUTSTANDING INDEBTEDNESS.

 

At December 31, 2017, we had outstanding borrowings of $9,922,500 of principal amount, of which:

 

 

approximately $5 0,000, at 10% interest, was due June 2004.  We are in default in the payment of principal and accrued interest;

 

approximately $ 150,000 at 10% interest is due in April 2019;

 

approximately $ 400,000 at 12% interest is due in April 2019;

 

approximately $ 2,190,000 at 10% interest is due in April 2020;

 

approximately $ 4,282,500 at 12% interest is due in April 2020;

 

approximately $ 2,650,000 at 3.5% interest is due in April 2020;

 

an d approximately $20 0,000 at 12% interest is due in April 2021.

 

No assurance can be given that the holder of the $5 0,000 in principal amount 10% Convertible Notes will not seek immediate collection of the amounts due and owing. Further, no assurance can be given that faced with future principal repayment and interest obligations, our cash flow from operations or external financing will be available or sufficient to enable us to meet our financial obligations.  If we are unable to extend the maturity dates of or repay our financial obligations, the holders could obtain a judgment against us in the amount of the borrowings and foreclose on our assets.  Such foreclosure would materially and adversely affect our ability to conduct our business.

 

WE HAVE HISTORICALLY NEEDED AND POTENTIALLY MA Y NEED ADDITIONAL FINANCING TO MEET OPERATING EXPENSES , THE TERMS OF WHICH MAY BE UNFAVORABLE TO OUR THEN-EXISTING STOCKHOLDERS.

 

Our plan of operations going forward may require us to raise additional capital if our reven ue projections are not realized. Even if our projections are realized, we may need to raise additional financing to meet our ongoing obligations, including the repayment of existing debt obligations currently in the amount of $9,922,500. In addition, we may also need to raise additional funds to meet known needs or to respond to future business opportunities, which may include the need to:

 

 

fund more rapid expansion;

 

fund additional capital or marketing expenditures;

 

develop new or enhanced features, services and products;

 

enhance our opera ting infrastructure;

 

respond to competitive pressures; or

 

acquire complementary businesses or necessary technologies.

 

If we raise additional capital through the issuance of debt, this will result in increased interest expense. If additional funds are raised through the issuance of equity or convertible debt securities, the percentage ownership of our stockholders will be reduced, these newly-issued securities may have rights, preferences or privileges senior to those of existing stockholders or debt holders , and the market price of our stock may be adversely affected.  We cannot assure you that additional financing will be available on terms favorable to us, or at all.  If adequate funds are not available or are not available on acceptable terms, our ability to fund our operations, repay our outstanding debt obligations and remain in business may be significantly limited.

 

 

IF WE ARE NOT ABLE TO RELIABLY MEET OUR DATA SECURITY, STORAGE AND MANAGEMENT REQUIREMENTS, OR IF WE EXPERIENCE ANY FAILURE OR INTERRUPTION IN THE DELIVERY OF OUR SERVICES OVER THE INTERNET, CUSTOMER SATISFACTION AND OUR REPUTATION COULD BE HARMED AND CUSTOMER CONTRACTS MAY BE TERMINATED.

 

As part of our current business model, we store and manage in excess of ten terabytes of data for our customers, resulting in substantial information technology infrastructure and ongoing technological challenges, which we expect to continue to increase over time. If we do not reliably meet these data security, storage and management requirements, or if we experience any failure or interruption in the delivery of our services over the Internet, customer satisfaction and our reputation could be harmed and this could lead to reduced revenues and increased expenses. Our hosting services are subject to service level agreements and, in the event that we fail to meet guaranteed service or performance levels, we could be subject to customer credits or termination of these customer contracts. If the cost of meeting these data security, storage and management requirements increases, our results of operations could be harmed.

 

A SYSTEM FAILURE COULD RESULT IN SIGNIFICANTLY REDUCED REVENUES; ANY SIGNIFICANT DISRUPTION IN OUR SERVICE COULD DAMAGE OUR REPUTATION, RESULT IN A POTENTIAL LOSS OF CLIENTS AND ADVERSELY AFFECT OUR FINANCIAL RESULTS.

 

We host our services, serve our customers and support our operations primarily from a co-location data center located in Cincinnati, Ohio, which is operated in conjunction with co-location services from CyrusOne. We also maintain a co-location facility  in Fort Lauderdale, Florida which also serves as a back-up facility for purposes of disaster recovery, and a co-location facility in Frankfurt, Germany. We do not have control over the operations of these facilities. Any system failure, including network, software or hardware failure that causes an interruption in our service could affect the performance of our software and result in reduced revenues. The servers that host our software are backed-up by remote servers, but we cannot be certain that the back-up servers will not fail or cause an interruption in our service.  These facilities and our customers’ clinical trial data could also be subject to and affected by computer viruses, malware, hacking and phishing attacks, electronic break-ins, intentional acts of vandalism or other similar disruptions or misconduct.  Our users depend on Internet service providers, online service providers and other web site operators for access to our products.  Each of these providers may have experienced significant outages in the past and could experience outages, delays and other difficulties due to system failures unrelated to our systems.  Further, our co-location facilities and systems are vulnerable to damage or interruption from fire, flood, power loss, telecommunications and/or power failure, cyber security attacks, terrorist attacks, break-ins, hurricanes, earthquake and similar events. Regionalized power loss caused by hurricanes or other storms if occurring over a long period of time, a decision to close the co-location facilities without adequate notice or other unanticipated problems could result in lengthy interruptions in our services and adversely impact our ability to service our clients.   Our insurance policies have low coverage limits and may not adequately compensate us for any such losses that may occur due to interruptions in our service.

 

Our co-location facilities providers have no obligations to renew their agreements with us on commercially reasonable terms, or at all. If we are unable to renew our agreements with the facilities providers on commercially reasonable terms, if our agreements with our facility providers are prematurely terminated, or if in the future we add additional co-location facility providers, we may experience costs or downtime in connection with the transfer to, or the addition of, new co-location facilities.

 

Any errors, defects, disruptions or other performance problems with our services could harm our reputation and may damage our customers ’ businesses. Interruptions in our services might significantly reduce our revenue, cause us to issue credits to customers, subject us to potential liability, cause customers to terminate their agreements with us and harm our renewal rates.

 

we may expand our business further through new acquisitions in the future. Any such acquisitions, AND OUR FAILURE TO MANAGE OUR GROWTH THEREFROM, could disrupt our business, harm our financial condition and dilute current stockholders ’ ownership interests in our company.

 

We intend to pursue potential acquisitions of, and investments in, businesses, technologies or products complementary to our business and periodically engage in discussions regarding such possible acquisitions.

 

Acquisitions involve numerous risks, including some or all of the following:  

 

 

difficulties in identifying and acquiring complementary products, technologies or businesses;

 

substantial cash expenditures;

 

incurrence of debt and contingent liabilities, some of which we may not identify at the time of acquisition;

 

difficulties in assimilating the operations and personnel of the acquired companies;

 

d iversion of management’s attention away from other business concerns;

 

risk associated with entering markets in which we have limi ted or no direct experience;

 

potential loss of key employees, customers and strategic alliances from either our current business or the target company ’s business; and

 

delays in customer purchases due to uncertainty and the inability to maintain relationshi ps with customers of the acquired businesses.

 

 

If we fail to properly evaluate acquisitions or investments, we may not achieve the anticipated benefits of such acquisitions, we may incur costs in excess of what we anticipate and management resources and at tention may be diverted from other necessary or valuable activities. An acquisition may not result in short-term or long-term benefits to us. The failure to evaluate and execute acquisitions or investments successfully or otherwise adequately address these risks could materially harm our business and financial results. We may incorrectly judge the value or worth of an acquired company or business. In addition, our future success will depend in part on our ability to manage the growth anticipated with these acquisitions.

 

Furthermore, the development or expansion of our business or any acquired business or companies may require a substantial capital investment by us. We may not have these necessary funds or they might not be available to us on acceptable terms or at all. We may also seek to raise funds for an acquisition by issuing equity securities or convertible debt, as a result of which our existing stockholders may be diluted or the market price of our stock may be adversely affected.

 

OUR REVENUES DERIVED FROM INTERNATIONAL OPERATIONS ARE SUBJECT TO RISK, INCLUDING RISKS RELATING TO UNFAVORABLE ECONOMIC, POLITICAL, LEGAL, REGULATORY, TAX, LABOR AND TRADE CONDITIONS IN THE FOREIGN COUNTRIES IN WHICH WE OPERATE, THAT COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR RESULTS OF OPERATIONS.

 

We currently have international office locations and business operations in Southampton, England, Leiden, the Netherlands and Bonn, Germany, and international customers principally located in Europe and East Asia accounted for 23% of total revenues for the year ended December 31, 2017 and 17% of total revenues for the year ended December 31, 2016.  International operations are subject to inherent risks. These risks include:

 

 

the economic conditions in these various foreign countries and their trading partners, including conditions resulting from disruptions in the world credit and equity markets;

 

political instability;

 

acts of terrorism;

 

greater difficulty in accounts receivable collection and enforcement of agreements and longer payment cycles;

 

compliance with foreign laws;

 

changes in regulatory requirements;

 

fewer legal protections for intellectual property and contract rights;

 

tariffs or other trade barriers;

 

staffing and managing foreign operations;

 

exposu re to currency exchange and interest rate fluctuations;

 

potentially adverse tax consequences; and

 

changes to taxation of offshore earnings.  

 

FAILURE TO COMPLY WITH THE U.S. FOREIGN CORRUPT PRACTICES ACT COULD SUBJECT US TO, AMONG OTHER THINGS, PENALTIES AND LEGAL EXPENSES THAT COULD HARM OUR REPUTATION AND HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

 

The Company is subject to the U.S. Foreign Corrupt Practices Act, or the FCPA, which generally prohibits covered entities and their intermediaries from engaging in bribery or making other prohibited payments to foreign officials for the purpose of obtaining or retaining business or other benefits. In addition, the FCPA imposes accounting standards and requirements on U.S. publicly traded corporations and their foreign affiliates, which are intended to prevent the diversion of corporate funds to the payment of bribes and other improper payments, and to prevent the establishment of “off books” slush funds from which such improper payments can be made. The Company is also subject to similar anticorruption legislation implemented in Europe under the Organization for Economic Co-operation and Development ’s Convention on Combating Bribery of Foreign Public Officials in International Business Transactions. The Company and its joint ventures, partners, independent representatives and agents operate in a number of jurisdictions that pose a high risk of potential violations of the FCPA and other anticorruption laws, based on measurements such as Transparency International’s Corruption Perception Index, and the Company utilizes joint ventures, partners, independent representatives and agents for whose actions the Company could be held liable under the FCPA. The Company informs its personnel, joint ventures, partners, independent representatives and agents of the requirements of the FCPA and other anticorruption laws, including, but not limited to their reporting requirements. The Company also has developed and will continue to develop and implement systems for formalizing contracting processes, performing due diligence on partners and agents, and improving its recordkeeping and auditing practices regarding these regulations. However, there is no guarantee that the Company’s employees, joint ventures, partners, independent representatives or other agents have not or will not engage in conduct undetected by the Company’s processes and for which the Company might be held responsible under the FCPA or other anticorruption laws.

 

 

If the Company ’s employees, joint ventures, partners, third-party sales representatives or other agents are found to have engaged in such practices, the Company could suffer severe penalties, including criminal and civil penalties, disgorgement and other remedial measures, including further changes or enhancements to its procedures, policies and controls, as well as potential personnel changes and disciplinary actions. Although the Company does not believe it is currently a target in any enforcement action, any investigation of any potential violations of the FCPA or other anticorruption laws by U.S. or foreign authorities could have an adverse impact on the Company’s business, financial condition and results of operations.

 

Certain private and foreign companies, including some of the Company ’s competitors, are not subject to prohibitions as strict as those under the FCPA or, even if subjected to strict prohibitions, such prohibitions may be laxly enforced in practice. If the Company’s competitors engage in corruption, extortion, bribery, pay-offs, theft or other fraudulent practices, they may receive preferential treatment from personnel of some companies or from government officials, giving the Company’s competitors an advantage in securing business and which would put the Company at a disadvantage.

 

EXTENSIVE GOVERNMENTAL REGULATION OF THE CLINICAL TRIAL PROCESS AND OUR PRODUCTS AND SERVICES COULD REQUIRE SIGNIFICANT COMPLIANCE COSTS AND HAVE A MATERIAL ADVERSE EFFECT ON THE DEMAND FOR OUR SOLUTIONS.

 

The clinical trial process is subject to extensive and strict regulation by the U.S. Food and Drug Administration and other regulatory authorities worldwide. Our software products, services and hosted solutions are also subject to state, federal and foreign regulations. Demand for our solutions is largely a function of such government regulation, which is generally increasing at the state and federal levels in the United States and elsewhere, and subject to change at any time. Changes in the level of regulation, including a relaxation in regulatory requirements or the introduction of simplified drug approval procedures, could have a material adverse effect on the demand for our solutions. For example, proposals to place caps on drug prices could limit the profitability of existing or planned drug development programs, making investment in new drugs and therapies less attractive to pharmaceutical companies. Similarly, the requirements in the United States, the European Union and elsewhere to create a detailed registry of all clinical trials could have an impact on customers ’ willingness to perform certain clinical studies. Likewise, a proposal for government-funded universal health care could subject expenditures for health care to governmental budget constraints and limits on spending. Until the new legislative agenda is finalized and enacted, it is not possible to determine the impact of any such changes.

 

Modifying our software products and services to comply with changes in regulations or regulatory guidance could require us to incur substantial costs. Further, changing regulatory requirements may render our solutions obsolete or make new products or services more costly or time consuming than we currently anticipate. Failure by us, our customers, or our competitors to comply with applicable regulations could result in increased regulatory scrutiny and enforcement. If our solutions fail to comply with government regulations or guidelines, we could incur significant liability or be forced to cease offering our applicable products or services. If our solutions fail to allow our customers to comply with applicable regulations or guidelines, customers may be unwilling to use our solutions and any such non-compliance could result in the termination of or additional costs arising from contracts with our customers.

 

IF OUR LICENSE TO USE THIRD-PARTY TECHNOLOGIES IN OUR PRODUCTS IS TERMINATED, WE MAY BE UNABLE TO DEVELOP, MARKET OR SELL OUR PRODUCTS.

 

We were dependent on a license agreement, as amended pursuant to which we obtained certain rights under intellectual property rights of a third party. This license agreement, and amendment thereto, could have been terminated on thirty (30) days ’ notice by the licensor if we were in default on our obligations under the license agreement, as amended, and failed to cure such default within the thirty (30) day period after notice was provided. The license imposed commercialization, certain sublicensing, payments, royalty, insurance, confidentiality, restrictions and other obligations on us. Our failure, or any third party's failure, to comply with the terms of this license agreement and amendment thereto could have resulted in our losing our rights to the license, which could have resulted in our being unable to develop or sell our products.

 

WE DEPEND PRIMARILY ON THE PHARMACEUTICAL, BIOTECHNOLOGY AND MEDICAL DEVICE INDUSTRIES AND ARE THEREFORE SUBJECT TO RISKS RELATING TO CHANGES IN THESE INDUSTRIES.

 

Our business depends on the clinical trials conducted or sponsored by pharmaceutical, biotechnology , CRO and medical device companies and other entities conducting clinical research. General economic downturns, increased consolidation or decreased competition in the industries in which these companies operate could result in fewer products under development or decreased pressure to accelerate product approval which, in turn, could materially adversely impact our revenues. Our operating results may also be adversely impacted by other developments that affect these industries generally, including:

 

 

the introduction or adoption of new technologies or products;

 

 

 

changes in third-party reimbursement practices;

 

changes in government regulation or governmental price controls;

 

changes in medical practices;

 

the assertion of product liability claims; and

 

changes in general business conditions.

 

Any decrease in R&D expenditures or in the size, scope or frequency of clinical trials conducted or sponsored by pharmaceutical, biotechnology, CRO or medical device companies or other entities as a result of the foregoing or other factors could materially adversely affect our operations or financial condition.

 

WE MAY BE REQUIRED TO SPEND SUBSTANTIAL TIME AND EXPENSE BEFORE WE RECOGNIZE A SIGNIFICANT PORTION OF THE REVENUES, IF ANY, ATTRIBUTABLE TO OUR CUSTOMER CONTRACTS.

 

The sales cycle for some of our software solutions frequently takes six months to a year or longer from initial customer contact to contract execution. During this time, we may expend substantial time, effort and financial resources without realizing any revenue with respect to the potential sale. In addition, in the case of our hosted solutions, we do not begin recognizing revenue until implementation cycles are complete. Moreover, while we begin recognizing revenue upon completion of the scope of work detailed in our contracts, it may be difficult for us to rapidly increase our revenue through additional sales in any period, as revenue from new customers is recognized over the applicable contract term, typically three months to five  years. As a result, we may not recognize significant revenues, if any, from some customers despite incurring considerable expense related to our sales and implementation process. Even if we do realize revenues from a contract, our pricing model may keep us from recognizing a significant portion of these revenues during the same period in which sales and implementation expenses were incurred. Those timing differences could cause our gross margins and profitability to fluctuate significantly from quarter to quarter. Similarly, a decline in new or renewed client contracts in any one quarter will not necessarily be fully reflected in the revenue in that quarter and may negatively affect our revenue in future quarters. This could cause our operating results to fluctuate significantly from quarter to quarter.

 

THE LOSS OF ONE OR MORE MAJOR CUSTOMERS COULD MATERIALLY AND ADVERSELY AFFECT OUR RESULTS OF OPERATIONS AND FINANCIAL CONDITION.

 

Our top five customers accounted for approximately 36% of our revenues for the year ended December 31, 2017 and approximately 37% of our revenues for the year ended December 31, 2016.  One customer accounted for 10% of our revenues for the year ended December 31, 2017 or approximately $2,691,000.  One customer accounted for 16% of our revenues for the year ended December 31, 2016, or approximately $4,167,000.  These customers can terminate our services at any time.  The loss of any of our major customers could have a material adverse effect on our results of operations or financial condition. We may not be able to maintain our customer relationships, and our customers may not renew their agreements with us, which could adversely affect our results of operations or financial condition. A significant change in the liquidity or financial position of any of these customers could also have a material adverse effect on the collectability of our accounts receivables, our liquidity and our future operating results.

 

WE COULD INCUR SUBSTANTIAL COSTS RESULTING FROM PRODUCT LIABILITY CLAIMS RELATING TO OUR PRODUCTS OR SERVICES OR OUR CUSTOMERS ’ USE OF OUR PRODUCTS OR SERVICES.

 

Any failure or errors in a customer ’s clinical trial or adverse event reporting obligations caused or allegedly caused by our products or services could result in a claim for substantial damages against us by our customers or the clinical trial participants, regardless of our responsibility for the failure. Although we are entitled to indemnification under our customer contracts against claims brought against us by third parties arising out of our customers’ use of our products, we might find ourselves entangled in lawsuits against us that, even if unsuccessful, divert our resources and energy and adversely affect our business. Further, in the event we seek indemnification from a customer, we cannot assure you that a court will enforce our indemnification right if challenged by the customer obligated to indemnify us or that the customer will be able to fund any amounts for indemnification owed to us. We also cannot assure you that our existing general liability or professional liability insurance coverage will continue to be available on reasonable terms or will be available in amounts sufficient to cover one or more large claims, or that the insurer will not disclaim coverage as to any future claim.

 

WE FACE INTENSE COMPETITION AND WILL HAVE TO COMPETE FOR MARKET SHARE.

 

There can be no assurance that our products will achieve or maintain a competitive advantage.   There are currently a number of companies who market services and products for web-based clinical trial data collection.  Barriers to entry on the internet are relatively low, and we expect competition to increase significantly in the future.  We face competitive pressures from numerous actual and potential competitors, both online and offline, many of which have longer operating histories, greater brand name recognition, larger customer bases and significantly greater financial, technical and marketing resources than we do.  We cannot assure you that the web-based clinical trials maintained by our existing and potential competitors will not be perceived by clinical trial sponsors as being superior to ours.

 

 

WE MAY BE UNABLE TO PREVENT COMPETITORS FROM USING OUR INTELLECTUAL PROPERTY, AND WE COULD FACE POTENTIALLY EXPENSIVE LITIGATION TO ASSERT OUR RIGHTS.   IF WE CANNOT PROTECT OUR PROPRIETARY INFORMATION, WE MAY LOSE A COMPETITIVE ADVANTAGE AND SUFFER DECREASED REVENUES AND CASH FLOW.

 

We are dependent, in part, on proprietary data, analytical computer programs and methods and related know-how for our day-to-day operations.   We rely on a combination of confidentiality agreements, contract provisions, license agreements, trademarks and trade secret laws to protect our proprietary rights.  Although we intend to protect our rights vigorously, to the extent that our intellectual property and other proprietary rights are not adequately protected, third parties might gain access to our proprietary information, develop and market products or services similar to ours, or use trademarks similar to ours, each of which could materially harm our business.  If we resort to legal proceedings to enforce our intellectual property rights or to determine the validity and scope of the intellectual property or other proprietary rights of others, the proceedings could be burdensome and expensive, even if we were to prevail. There can be no assurance we will be successful in protecting our proprietary rights.  If we are unable to protect our proprietary rights, or if our proprietary information and methods become widely available, we may lose our ability to obtain or maintain a competitive advantage within our market niche, which may have a material adverse effect on our business, results of operations or financial condition.

 

CLAIMS THAT WE OR OUR TECHNOLOGIES INFRINGE UPON THE INTELLECTUAL PROPERTY OR OTHER PROPRIETARY RIGHTS OF A THIRD PARTY MAY REQUIRE US TO INCUR SIGNIFICANT COSTS, TO ENTER INTO ROYALTY OR LICENSING AGREEMENTS OR TO DEVELOP OR LICENSE SUBSTITUTE TECHNOLOGY.

 

We have been, and may in the future be, subject to claims that our technologies infringe upon the intellectual property or other proprietary rights of a third party. Although we believe that our software solutions do not infringe the patents or other intellectual property rights of any third party, we cannot assure you that our technology does not infringe patents or other intellectual property rights held or owned by others or that they will not in the future.  Any future claims of infringement could cause us to incur substantial costs defending against such claims, even if the claims are without merit, and could distract our management from our business. Moreover, any settlement or adverse judgment resulting from such claims could require us to pay substantial amounts or obtain a license to continue to use the technology that is the subject of the claim, or otherwise restrict or prohibit our use of the technology. There can be no assurance that we would be able to obtain a license from the third party asserting the claim on commercially reasonable terms, if at all, that we would be able to successfully develop alternative technology on a timely basis, if at all, or that we would be able to obtain a license from another provider of suitable alternative technology to permit us to continue offering, and our customers to continue using, the applicable technology. In addition, we generally provide in our customer agreements that we will indemnify our customers against third-party infringement claims relating to our technology provided to the customer, which could obligate us to fund significant amounts. Infringement claims asserted against us or our licensor may have a material adverse effect on our business, results of operations or financial condition.

 

FAILURE TO ADAPT TO EVOLVING TECHNOLOGIES AND USER DEMANDS COULD RESULT IN THE LOSS OF USERS .

 

To be successful, we must adapt to rapidly changing technologies and user demands by continuously enhancing our products and services and introducing new products and services.   If we need to modify our products and services or infrastructure to adapt to changes affecting clinical trials, we could incur substantial development or acquisition costs.  As described below, we will be dependent upon the availability of additional financing to fund these development and acquisition costs.  If these funds are not available to us, and if we cannot adapt to these changes, or do not sufficiently increase the features and functionality of our products and services, our users may switch to the product and service offerings of our competitors.

 

WE MAY BE UNABLE TO ADEQUATELY DEVELOP OUR SYSTEMS, PROCESSES AND SUPPORT IN A MANNER THAT WILL ENABLE US TO MEET THE DEMAND FOR OUR SERVICES.

 

Our future success will depend on our ability to develop the infrastructure, including additional hardware and software, and implement the services, including customer support, necessary to meet the demand for our services.   In the event we are not successful in developing the necessary systems and implementing the necessary services on a timely basis, our revenues could be adversely affected, which would have a material adverse effect on our financial condition.

 

FAILURE TO MANAGE GROWTH EFFECTIVELY COULD HARM OUR BUSINESS.

 

To manage our current and anticipated future growth effectively, we must continue to maintain and may need to enhance our information technology infrastructure, financial and accounting systems and controls and manage expanded operations in geographically distributed locations. Our failure to manage our growth effectively could have a material adverse effect on our business, operating results or financial condition.

 

 

IN THE COURSE OF CONDUCTING OUR BUSINESS, WE POSSESS OR COULD BE DEEMED TO POSSESS PERSONAL MEDICAL INFORMATION IN CONNECTION WITH THE CONDUCT OF CLINICAL TRIALS, WHICH IF WE FAIL TO KEEP PROPERLY PROTECTED, COULD SUBJECT US TO SIGNIFICANT LIABILITY.

 

Our software solutions are used to collect, manage and report information in connection with the conduct of clinical trials. This information is or could be considered to be personal medical information of the clinical trial participants. Regulation of the use and disclosure of personal medical information is complex and growing. Increased focus on individuals ’ rights to confidentiality of their personal information, including personal medical information, could lead to an increase of existing and future legislative or regulatory initiatives giving direct legal remedies to individuals, including rights to damages, against entities deemed responsible for not adequately securing such personal information. In addition, courts may look to regulatory standards in identifying or applying a common law theory of liability, whether or not that law affords a private right of action. Since we receive and process personal information of clinical trial participants from our customers, there is a risk that we could be liable if there were a breach of any obligation to a protected person under contract, standard of practice or regulatory requirement. If we fail to properly protect this personal information that is in our possession or deemed to be in our possession, we could be subjected to significant liability.

 

FUTURE SALES OF SHARES BY EXISTING STOCKHOLDERS IN THE PUBLIC MARKET AS WELL AS THE ISSUANCE OF ADDITIONAL SHARES OF OUR COMMON STOCK COULD RESULT IN A DECLINE IN THE MARKET PRICE OF THE STOCK.

 

Sales of a substantial number of shares of our common stock in the public market, or the perception that such sales could occur, could adversely affect the market price of our common stock, may make it more difficult for our stockholders to sell their common stock at a time and price that the stockholder deems appropriate  and could damage our ability to raise capital through the sale of our equity securities.

 

At March 29 , 2018, we had 150,209,472 shares of common stock issued and outstanding and 42,505,597 shares are issuable (i) upon the conversion of convertible debt, (ii) for accrued interest, and (iii) upon the exercise of warrants and options.  Of the issued shares, 76,860,489 shares, including all shares held by our “affiliates”, are subject to the restrictions set forth in Rule 144 under the Securities Act of 1933, as amended (“Securities Act”), and 73,348,983 shares are freely transferable without restriction or registration under the Securities Act.  In general, Rule 144 permits a stockholder who has owned restricted shares for at least six months, to sell without registration, within a three-month period, up to one percent of our then outstanding common stock.  In addition, stockholders other than our officers, directors or 5% or greater stockholders who have owned their shares for at least six months may sell them without the volume limitation.

 

We may also issue our shares of common stock or securities convertible into our common stock from time to time in connection with a financing, acquisition, investment or otherwise. Any such issuance could result in substantial dilution to our existing stockholders and cause the trading price of our common stock to decline.

 

THE EXERCISE OF OUTSTANDING OPTIONS AND WARRANTS AND THE CONVERSION OF OUTSTANDING CONVERTIBLE DEBENTURES WILL BE DILUTI VE TO OUR EXISTING STOCKHOLDERS.

 

As of March 29 , 2018, we had a total of 42,505,597 shares of our common stock issuable upon conversion or exercise of options, warrants and convertible debt and payment of accrued interest.  The issuance of our common stock upon the exercise and/or the conversion of these convertible securities and the payment of accrued interest will have a dilutive effect on our existing stockholders.

 

THE 250,000 SHARES OF SERIES D PREFERRED STOCK ISSUED IN 2010 PROVIDE SUPER-VOTING RIGHTS THAT RESULTED IN A CHANGE OF CONTROL OF THE CORPORATION .

 

Each share of the Series D Preferred Stock entitles the holder to 400 votes at any meeting of our stockholders and such shares of Series D Preferred Stock will vote together with the common stockholders, provided that for the election or removal of directors the shares of Series D Preferred Stock will be voted in the same percentage as all voting shares of common stock voted for each director.  As a result of the change in control, the holder of the Series D Preferred Shares could vote the shares in a manner that could be contrary to the interests of the holders of our common stock.  All shares of the Series D Preferred Stock are owned by our Executive Chairman, Chairman of the Board of Directors and largest shareholder, Cornelis F. Wit.

 


CORNELIS F. WIT, EXECUTIVE CHAIRMAN AND CHAIRMAN OF THE BOARD OF DIRECTORS, CONTROLS APPROXIMATELY 60 % OF OUR OUTSTANDING VOTING SECURITIES. THIS CONCENTRATION OF OWNERSHIP MAY HAVE AN EFFECT ON MATTERS REQUIRING THE APPROVAL OF OUR STOCKHOLDERS, INCLUDING TRANSACTIONS THAT ARE OTHERWISE FAVORABLE TO OUR STOCKHOLDERS.

 

As of March 29 , 2018, Cornelis F. Wit, our Executive Chairman, Chairman of the Board of Directors and largest stockholder ("Mr. Wit"), owned approximately 60% of our outstanding voting securities. This majority ownership of voting securities may delay, deter or prevent a change in control and, given Mr. Wit’s ability to control the outcome of certain matters requiring stockholder approval, may make some transactions more difficult or impossible to complete without the support of Mr. Wit, regardless of the impact of such transaction on our other stockholders.

 

THERE IS ONLY A LIMITED TRADING MARKET FOR OUR COMMON STOCK.

 

There is a limited trading market for our common stock.   We cannot predict the extent to which investor interest in us will lead to the development of an active trading market or how liquid that trading market might become.  If a liquid trading market does not develop or is not sustained, investors may find it difficult to dispose of shares of our common stock and may suffer a loss of all or a substantial portion of their investment in our common stock.

 

PROVISIONS OF OUR CERTIFICATE OF INCORPORATION AND BY-LAWS MAY DELAY OR PREVENT A TAKE-OVER WHICH MAY NOT BE IN THE BEST INTERESTS OF OUR COMMON STOCKHOLDERS.

 

Provisions of our Certificate of Incorporation and By-laws may be deemed to have anti-takeover effects, which include when and by whom special meetings of our stockholders may be called, and may delay, defer or prevent a takeover attempt. In addition, our Certificate of Incorporation authorize the issuance of up to 10,000,000 shares of preferred stock with such rights and preferences as may be determined from time to time by our Board of Directors, of which 250,000 shares are issued and outstanding as of March 29, 2018.  Our Board of Directors may, without stockholder approval, issue additional series of preferred stock with dividends, liquidation, conversion, voting or other rights which could adversely affect the voting power or other rights of the holders of our common stock.

 

ITEM 1B.        UNRESOLVED STAFF COMMENTS

 

None.

 

ITEM 2.           PROPERTIES

 

Our corporate headquarters and other material leased real property as of December 31, 2017 are shown in the following table. We do not own any real property.

 

Location

   

Use

   

Size

   

Expiration of l ease

Fort Lauderdale, Florida

   

Corporate headquarters

   

1 4,825 square feet

   

February 2023

Somerset , New Jersey

   

Office space

   

3,287 square feet

   

March 2021

Bonn, Germany

   

Europ ean headquarters

   

3,714 square feet

   

July 201 8

Southampton, United Kingdom

   

Office s pace

   

1,415 square feet

   

September 20 20

Leiden, Netherlands

 

Office s pace

 

285 square feet

 

October 2018

 

Our principal executive offices are locat ed in commercial office space at 2101 West Commercial Blvd., Fort Lauderdale, Florida, and our telephone number is (954) 473-1254.   Our annual payment under this lease is approximately $414,000.

 

We have a regional operating office located in commercial office space at 399 Campus Drive, Somerset, New Jersey.  Our annual payment under this lease is approximately $53,000.

 

Our European headquarters are located in commercial office space at Kaiserstrasse 139-141, Bonn, Germany.  Our annual payment under this lease is approximately 60,000 Euros or approximately $75,000.

 

We have a research and product development office in the UK for our TrialOne software application. The office is located at Medino House, Rushington Business Park, Totten, Southampton, UK. Our annual payment under this lease is approximately 46,000 British Pounds or approximately $65,000.

 

We have an office in the Netherlands for our Promasys software application. The office is located at Zernikedreef 8, 2333 CL, Leiden, the Netherlands. Our annual payment under this lease is approximately 5,100 Euros or approximately $6,300.

 

We believe these facilities and additional or alternative space available to us will be adequate to meet our needs for the foreseeable future.

 

 

ITEM 3.           LEGAL PROCEEDINGS

 

None.

 

ITEM 4.           MINE SAFETY DISCLOSURES

 

Not Applicable.

   

PART II

 

ITEM 5.           MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

 

Our common stock is traded on a limited basis on the OTC QX Marketplace under the symbol OMCM. The following table sets forth the range of high and low bid prices for our common stock as reported by the OTCQX Marketplace for the periods indicated.  The quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission, and may not represent actual transactions.  The quotation of our common stock on the OTCQX Marketplace Board does not assure that a meaningful, consistent and liquid market for such securities currently exists.

 

   

High

   

Low

 

Fiscal 2017

               

1st Quarter

  $ 0.25     $ 0.18  

2nd Quarter

  $ 0.27     $ 0.21  

3rd Quarter

  $ 0.26     $ 0.19  

4th Quarter

  $ 0.35     $ 0.26  
                 

Fiscal 2016

               

1st Quarter

  $ 0.26     $ 0.18  

2nd Quarter

  $ 0.26     $ 0.16  

3rd Quarter

  $ 0.25     $ 0.14  

4th Quarter

  $ 0.24     $ 0.19  

 

On March 29 , 2018 the closing price of our common stock as reported on the OTCQX Marketplace was $0.30. At March 29, 2018 we had approximat ely 400  stock holders of record; however, we believe that we have in excess of 1,000 beneficial owners of our common stock.

 

Dividend Policy

 

Holders of our common stock are entitled to cash dividends when, and as may be declared by the Board of Directors.   We have never declared or paid any cash dividends on our common stock.  We currently expect to retain future earnings, if any, to finance the growth and development of our business and we do not anticipate that any cash dividends will be paid in the foreseeable future.  Our future payment of dividends will be subject to the discretion of our Board of Directors and will depend on our earnings, capital requirements, expansion plans, financial condition and other relevant factors.  We are currently restricted under Delaware corporate law from declaring any cash dividends due to our current working capital and stockholders’ deficit.  There can be no assurance that cash dividends of any kind will ever be paid.

 

Additionally, pursuant to the terms of the Company ’s 5% Series A Convertible Preferred Stock, Series B Convertible Preferred Stock and Series C Convertible Preferred Stock (collectively, the “Preferred Shares”), the Company is prohibited from declaring and paying dividends on the Company’s common stock until all accrued and unpaid dividends are paid on such Preferred Shares. As of December 31, 2017, the accrued and unpaid dividends on the Series B Convertible Preferred Stock and Series C Convertible Preferred Stock were $2,081,980.

 

Recent Sales of Unregistered Securities

 

On December 31, 2017, the Company issued 500,000 shares of common stock to DataSci, LLC (“DataSci”), pursuant to the exercise of warrants at an exercise price of $.01 per share, for an aggregate purchase price of $5,000. This issuance of common stock was exempt from registration pursuant to Section 4(a)(2) of the Securities Act. DataSci received the warrants on April 2, 2009 pursuant to the Settlement and Licensing Agreement by and between DataSci and the Company.

 

ITEM 6.           SELECTED FINANCIAL DATA

 

Not applicable to a smaller reporting company.

 

ITEM 7.           MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

General

 

The following information should be read in conjunction with the information contained in our audited consolidated financial statements and notes thereto appearing elsewhere herein and other information set forth in this Annual Report.

 

 

Forward-Looking Statements

 

Statements contained in this Annual Report that are not historical fact are "forward-looking statements." These statements can often be identified by the use of forward-looking terminology such as "estimate," "project," "believe," "expect," "may," "will," "should," "intends," or "anticipates" or the negative thereof or other variations thereon or comparable terminology, or by discussions of strategy that involve risks and uncertainties. We wish to caution the reader that these forward-looking statements, contained in this Annual Report regarding matters that are not historical facts, are only predictions and are based on information available at the time and/or management’s good faith belief with respect to future events. No assurance can be given that plans for the future will be consummated or that the future results indicated, whether expressed or implied, will be achieved. While sometimes presented with numerical specificity, these plans and projections and other forward-looking statements are based upon a variety of assumptions, which we consider reasonable, but which nevertheless may not be realized. Because of the number and range of the assumptions underlying our projections and forward-looking statements, many of which are subject to significant uncertainties and contingencies that are beyond our reasonable control, some of the assumptions inevitably will not materialize, and unanticipated events and circumstances may occur subsequent to the date of this Annual Report. Therefore, our actual experience and results achieved during the period covered by any particular projections or forward-looking statements may differ substantially from those projected. Consequently, the inclusion of projections and other forward-looking statements should not be regarded as a representation by us or any other person that these plans will be consummated or that estimates and projections will be realized, and actual results may vary materially. There can be no assurance that any of these expectations will be realized or that any of the forward-looking statements contained herein will prove to be accurate. Forward-looking statements speak only as of the date the statement was made. The Company does not undertake any obligation to update or revise any forward-looking statement made by it or on its behalf, whether as a result of new information, future events or otherwise.

 

Overview

 

We are a healthcare technology company that provides web-based electronic data capture (“EDC”) solutions and related value-added services to pharmaceutical and biotechnology companies, CROs and other clinical trial sponsors worldwide. Our proprietary EDC and eClinical software applications, TrialMaster ® ; TrialOne ®; IRTMaster™; Promasys® ; and eClinical Suite™ (the “eClinical Products” or “eClinical Solutions”), allow clinical trial sponsors and investigative sites to securely collect, validate, transmit and analyze clinical trial data.

 

During fiscal 2017 we sought to build and expand on our strategic efforts. The primary focus of our strategy includes:

 

 

Stimulating demand by providing clinical trial sponsors with high value eClinical applications and services;

 

An emphasis on penetrating the Phase I trial market with our dedicated Phase I solution, TrialOne;

 

Broadening our eClinical suite of services and software applications on an organic basis and on a selective basis via the acquisition or licensing of complementary solutions; and

 

Expanding our business deve lopment efforts in Europe and East Asia to capitalize on our operational and clinical capabilities vis-à-vis our competition in that geographic market.

 

Our business development focus continues to include increasing our penetration of all phases of the clinical trial market with a particular emphasis on becoming the market leader in Phase I EDC services. We believe this market is an operating and strategic strength of the Company due to the inherent flexibility of our solutions including the solutions provided by our TrialOne products and services. We believe we have the ability to produce trials more quickly and economically than our competitors for this specialized and large market. We expect to experience increased success in penetrating the market for larger pharmaceutical, biotechnology and medical device clinical trial sponsors and CROs as we continue expanding our marketing and sales efforts during 2018.

 

 

The Year ended December 31, 2017 compared to the Year ended December 31, 2016

 

Results of Operations

 

A summarized version of our results of operations for the years ended December 31, 2017 and December 31, 2016 is included in the table below.

 

Summarized Statement of Operations

 

For the year ended

 

December 31,

 
           

% of

           

% of

    $    

%

 
   

2017

   

Revenues

   

2016

   

Revenues

   

Change

   

Change

 

Total revenues

  $ 26,979,658             $ 25,419,510             $ 1,560,148       6.1 %
                                                 

Cost of goods sold

    5,280,890       19.6 %     5,374,832       21.1 %     (93,942 )     -1.7 %
                                                 

Gross margin

    21,698,768       80.4 %     20,044,678       78.9 %     1,654,090       8.3 %
                                                 

Salaries, benefits and related taxes

    13,200,837       48.9 %     11,383,727       44.8 %     1,817,110       16.0 %

Rent

    1,125,147       4.2 %     1,071,363       4.2 %     53,784       5.0 %

Consulting services

    321,472       1.2 %     185,340       0.7 %     136,132       73.4 %

Legal and professional fees

    533,221       2.0 %     364,859       1.4 %     168,362       46.1 %

Other expenses

    1,627,514       6.0 %     1,411,384       5.6 %     216,130       15.3 %

Selling, general and administrative

    1,356,427       5.0 %     1,462,774       5.8 %     (106,347 )     -7.3 %

Total operating expenses

    18,164,618       67.3 %     15,879,447       62.5 %     2,285,171       14.4 %
                                                 

Operating income/(loss)

    3,534,150       13.1 %     4,165,231       16.4 %     (631,081 )     -15.2 %
                                                 

Interest expense

    (1,367,120 )     -5.1 %     (1,339,902 )     -5.3 %     (27,218 )     2.0 %

Interest income

    593       0.0 %     2       0.0 %     591       29,550.0 %

Change in derivatives

    795,779       2.9 %     (2,657,910 )     -10.5 %     3,453,689       129.9 %

Transaction gain/(loss)

    5,010       0.0 %     (64,472 )     -0.3 %     69,482       107.8 %
                                                 

Income/(loss) before income taxes

    2,968,412       11.0 %     102,949       0.4 %     2,865,463       2,783.4 %

Income tax (expense)

    (1,194 )     0.0 %     (1,069 )     0.0 %     (125 )     11.7 %

Net income/(loss) attributable to common stockholders

  $ 2,967,218       11.0 %   $ 101,880       0.4 %   $ 2,865,338       2,812.5 %

 

Revenues for the year ended December 31, 2017 increased 6.1% from the year ended December 31, 2016. The table below provides a comparison of our recognized revenues for the years ended December 31, 2017 and December 31, 2016.

 

   

For the year ended

                 

Revenue activity

 

December 31, 2017

   

December 31, 2016

   

$ Change

   

% Change

 

Set-up fees

  $ 4,981,941       18.5 %   $ 6,658,987       26.2 %   $ (1,677,046 )     -25.2 %

Change orders

    1,540,167       5.7 %     1,212,153       4.8 %     328,014       27.1 %

Maintenance

    5,107,787       18.9 %     4,803,171       18.9 %     304,616       6.3 %

Software licenses

    10,658,977       39.5 %     7,885,023       31.0 %     2,773,954       35.2 %

Professional services

    3,359,554       12.5 %     3,843,641       15.1 %     (484,087 )     -12.6 %

Hosting

    1,331,232       4.9 %     1,016,535       4.0 %     314,697       31.0 %

Total

  $ 26,979,658       100.0 %   $ 25,419,510       100.0 %   $ 1,560,148       6.1 %

 

Overall Revenue increased by approximately $1 .6 Million or 6.1% for the year ended December 31, 2017 compared to the year ended December 31, 2016. This is primarily the result of an increase in software licenses.

 

We recorded revenue of $ 20,250,111 including $6,499,120 from licensing, $4,981,941 from set-up fees, and $3,507,439 from maintenance, associated with our TrialMaster software during the year ended December 31, 2017 compared to revenue of $19,865,619, including $6,658,987 from set-up fees, $6,212,624 from licensing, and $3,133,648 from maintenance, for the year ended December 31, 2016.  The increase in revenue is primarily the result of increased business from both new and existing clients.

 

We recorded revenue of $ 4,536,986 associated with our TrialOne software for the year ended December 31, 2017 compared to revenue of $3,003,712 for the year ended December 31, 2016.  TrialOne revenues are primarily comprised of license subscriptions, professional services and maintenance services since the software is currently primarily sold under a technology transfer basis.

 

 

We recorded revenue of $1, 680,090 associated with our eClinical Suite software for the year ended December 31, 2017 compared to revenue of $1,548,124 for the year ended December 31, 2016.  The eClinical Suite revenues are primarily comprised of license subscriptions and revenues associated with our hosting and maintenance services.

 

We recorded $ 218,667 in revenues from hosting activities and $880,988 in maintenance associated with the eClinical Suite for the year ended December 31, 2017 as compared to $243,267 in revenues from hosting activities and $1,104,346 in maintenance for the year ended December 31, 2016.  Generally, these revenues are paid quarterly and are connected to hosting and client support for clients licensing that application.

 

We recorded revenue of $ 512,471, including $101,218 from licensing and $251,483 from maintenance, associated with our Promasys software for the year ended December 31, 2017 compared to revenue of $654,804, including $193,475 from licensing and $324,251 from maintenance, for the year ended December 31, 2016.

 

Our TrialMaster EDC application ha d historically been sold on an application service provider (“ASP”) basis that provides EDC and other services such as an enterprise management suite which assists our clients in the pharmaceutical, biotechnology and medical device industries in accelerating the completion of clinical trials. Our eClinical Suite and TrialOne software applications have historically been sold on a licensed or technology transfer basis.  

 

Generally, ASP contracts will range in duration from one month to several years. ASP Setup fees are generally recognized in accordance with Accounting Standards Codification 605 (“ASC 605”) “Revenue Recognition” , which requires that the revenues be recognized ratably over the life of the contract. ASP maintenance fee revenues are earned and recognized monthly. Costs associated with contract revenues are recognized as incurred.

 

License contracts are typically sold on a subscription basis that takes into account system usage both on a data volume and system user basis.   Pricing includes additional charges for consulting services associated with the installation, validation, training and deployment of our eClinical Solutions.  Licensed contracts of the eClinical Suite have historically been sold on a perpetual license basis with hosting and maintenance charges being paid annually.  The Company expects any licenses it sells of its eClinical Solutions to be sold in three to five year term licenses.

 

Our top five customers accounted for approximately 36% of our revenues during the year ended December 31, 2017 and approximately 37% of our revenues during the year ended December 31, 2016.  One customer accounted for approximately 10% of our revenues during the year ended December 31, 2017.   One customer accounted for approximately 16% of our revenues during the year ended December 31, 2016. The loss of any of these contracts or these customers in the future could adversely affect our results of operations.

 

Cost of goods sold decreased approximately 2% or $93,942 for the year ended December 31, 2017 as compared to the year ended December 31, 2016.  Cost of goods sold were approximately 20% of revenues for the year ended December 31, 2017 compared to approximately 21% for the year ended December 31, 2016. Cost of goods sold relates primarily to salaries and related benefits associated with the programmers, developers and systems analysts producing clinical trials on behalf of our clients and pass-through expenses.

 

Overall, total operating expenses increased approximately 14% for the year ended December 31, 2017 compared to the year ended December 31, 2016.  Total operating expenses were approximately 67% of revenues during the year ended December 31, 2017 compared to approximately 63% of revenues for the year ended December 31, 2016. Operating expenses increased during the year ended December 31, 2017 primarily due to increases in salary and related expenses.

 

Salaries and related expenses were our biggest operating expense at 7 3% of total operating expenses for the year ended December 31, 2017 compared to 72% of total operating expenses for the year ended December 31, 2016.  Salaries and related expenses increased 16% for the year ended December 31, 2017 compared to the year ended December 31, 2016.  The increase in salary expense is primarily related to increases in headcount resulting from the successful procurement of new business.  The table below provides a summary of the significant components of salary and related expenses by primary cost category.

 

   

For the year ended

                 

Expense Category

 

December 31, 2017

   

December 31, 2016

   

$ Change

   

% Change

 

OmniComm corporate operations

  $ 9,167,354     $ 7,859,534     $ 1,307,820       16.6 %

New Jersey operations office

    1,024,865       1,005,264       19,601       1.9 %

OmniComm Europe, GmbH

    637,898       674,312       (36,414 )     -5.4 %

OmniComm Ltd.

    899,224       766,354       132,870       17.3 %

OmniComm Spain S.L.

    392,226       308,689       83,537       27.1 %

OmniComm Systems B.V.

    510,748       547,270       (36,522 )     -6.7 %

Employee stock compensation

    568,522       222,304       346,218       155.7 %

Total salaries and related expenses

  $ 13,200,837     $ 11,383,727     $ 1,817,110       16.0 %

 

 

As of December 31, 2017 we employed 140 employees and consultants Company-wide as follows: 66 out of our headquarters in Fort Lauderdale, Florida, 9 out of a regional operating office in Somerset, New Jersey and 27 in remote locations throughout the United States and Canada.  Our wholly-owned subsidiary, OmniComm Europe, GmbH, employs 18 in Bonn, Germany.  Our wholly-owned subsidiary, OmniComm Ltd., employs 13 in Southampton, England.  Our wholly-owned subsidiary, OmniComm Spain, S. L. employs 2 in Barcelona, Spain.  Our wholly-owned subsidiary, OmniComm Systems B.V. employs 4 in Leiden, the Netherlands and 1 in Japan. We expect to continue to selectively add experienced sales and marketing personnel over the next year in an effort to increase our market penetration, particularly as it relates to the largest pharmaceutical, biotechnology and CRO customers and to continue broadening our client base domestically as well as internationally.

 

During the year ended December 31, 2017 we incurred $568,522 and during the year ended December 31, 2016 we incurred $222,304 in salary expense in connection with ASC 718 Compensation – Stock Compensation , which establishes standards for transactions in which an entity exchanges its equity instruments for services from employees. This standard requires companies to measure the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award.

 

Rent and related expenses increased by 5.0% during the year ended December 31, 2017 as compared to the year ended December 31, 2016.  The table below details the significant portions of our rent expense.  In particular, the increase in 2017 is associated with our expansion of our corporate office.  Our primary data site is located at a co-location facility in Cincinnati, Ohio and we will continue utilizing this facility for the foreseeable future since it is designed to ensure 100% production system up-time and to provide system redundancy. We utilize co-location and disaster recovery space in the Fort Lauderdale, Florida area. This facility provides us with disaster recovery and business continuity services for our operations.  In 2015 we added a co-location facility in Frankfurt, Germany. We currently lease office space in Bonn, Germany for our European subsidiary, OmniComm Europe, GmbH.  That lease expires in July 2018.  We currently lease office space for a regional operating office in Somerset, New Jersey under a lease that expires in March 2021.  Our OmniComm Ltd. subsidiary leases office space in Southampton, UK under a lease that expires in September 2020.  Our OmniComm Systems B.V. subsidiary leases office space in Leiden, the Netherlands under a lease that expires in October 2018. Our Fort Lauderdale, Florida corporate office lease expires in February 2023.  The table below provides the significant components of our rent related expenses by location or subsidiary.  Included in rent for the year ended December 31, 2017 was a credit of $3,156 in non-cash, straight line rent expense recorded to give effect to contractual, inflation-based rent increases in our leases.

 

   

For the year ended

                 

Expense Category

 

December 31, 2017

   

December 31, 2016

   

$ Change

   

% Change

 

Corporate office

  $ 414,489     $ 312,884     $ 101,605       32.5 %

Co-location and disaster recovery facilities

    509,162       474,369       34,793       7.3 %

New Jersey operations office

    52,592       53,414       (822 )     -1.5 %

OmniComm Europe, GmbH

    79,798       78,651       1,147       1.5 %

OmniComm Ltd.

    58,965       59,953       (988 )     -1.6 %

OmniComm Spain S.L.

    7,602       6,613       989       15.0 %

OmniComm Systems B.V.

    5,695       7,074       (1,379 )     -19.5 %

Straight-line rent expense

    (3,156 )     78,405       (81,561 )     -104.0 %

Total

  $ 1,125,147     $ 1,071,363     $ 53,784       5.0 %

 

Consulting services expense increased to $321,472 for the year ended December 31, 2017 compared to $185,340 for the year ended December 31, 2016, an increase of $136,132 or 73.4%. Consulting services were comprised of fees paid to consultants for help with developing our computer applications and for services related to our sales and marketing efforts. The table provided below provides the significant components of the expenses incurred related to consulting services. Consulting fees for product development increased for the year ended December 31, 2017 as we increased the utilization of the services of third-party sources for this work. Consulting fees for sales and marketing were lower for the year ended December 31, 2017 as we decreased the utilization of the services of third-party sources for this work.

 

   

For the year ended

                 

Expense Category

 

December 31, 2017

   

December 31, 2016

   

$ Change

   

% Change

 

Sales and marketing

  $ 77,714     $ 118,500     $ (40,786 )     -34.4 %

Product development

    243,758       66,840       176,918       264.7 %

Total

  $ 321,472     $ 185,340     $ 136,132       73.4 %

 

 

Legal and professional fees increased 46.1% for the year ended December 31, 2017 compared to the year ended December 31, 2016. Professional fees include fees paid to our auditors for services rendered on a quarterly and annual basis in connection with our SEC filings, fees paid to investment bankers for investor relations and related services, and fees paid to our attorneys in connection with representation in matters involving litigation and acquisitions or for services rendered to us related to employment, securities and SEC related matters. The table below compares the significant components of our legal and professional fees for the years ended December 31, 2017 and December 31, 2016, respectively.

 

   

For the year ended

                 

Expense Category

 

December 31, 2017

   

December 31, 2016

   

$ Change

   

% Change

 

Financial advisory

  $ 52,974     $ -0-     $ 52,974       n/a  

Audit and related

    46,777       50,143       (3,366 )     -6.7 %

Accounting services

    269,543       180,389       89,154       49.4 %

Legal-employment related

    32,113       16,943       15,170       89.5 %

Legal-financial related

    121,014       84,425       36,589       43.3 %

General legal

    10,800       32,959       (22,159 )     -67.2 %

Total

  $ 533,221     $ 364,859     $ 168,362       46.1 %

 

Selling, general and administrative expenses (“SG &A”) decreased approximately 7% for the year ended December 31, 2017 compared to the year ended December 31, 2016. This decrease is primarily due to a decrease in our license expense. During the year ended December 31, 2017 we recorded a credit of $108,702 in license fees associated with our license agreement with DataSci, LLC compared to an expense of $94,129 during the year ended December 31, 2016. In addition, SG&A relates primarily to costs incurred in running our offices in Fort Lauderdale, Florida, Somerset, New Jersey, Southampton, England, Leiden, the Netherlands and Bonn, Germany on a day-to-day basis and other costs not directly related to other captioned items in our income statement. SG&A includes the cost of office equipment and supplies, the costs of attending conferences and seminars and other expenses incurred in the normal course of business. In 2017 we spent approximately $701,000 on marketing, sales and advertising as compared to approximately $712,000 in 2016. We expect that the 2018 marketing, sales and advertising expenses will be approximately $1,000,000 as we plan to increase our attendance at tradeshows and our marketing efforts worldwide.

 

During the year ended December 31, 2017 we recognized $130,346 in bad debt expense compared to bad debt expense of $132,767 for the year ended December 31, 2016.  During 2017, we continued to carefully and actively manage our potential exposure to bad debt by closely monitoring our accounts receivable and proactively taking the action necessary to limit our exposure.  We believe that our current allowance for uncollectible accounts accurately reflects any accounts which may prove uncollectible during fiscal 2018.

 

Interest expense was $ 1,367,120 during the year ended December 31, 2017 compared to $1,339,902 for the year ended December 31, 2016, an increase of $27,218.  Interest incurred to related parties was $947,688 during the year ended December 31, 2017 and $918,189 for the year ended December 31, 2016.  Included in interest expense for both periods is the accretion of discounts recorded related to financial instrument derivatives that were deemed a part of the financings that we entered into.  The table below provides detail on the significant components of interest expense for the years ended December 31, 2017 and December 31, 2016.

 

   

For the year ended

                 

Debt Description

 

December 31, 2017

   

December 31, 2016

   

$ Change

   

% Change

 

Accretion of discount from derivatives

  $ 296,182     $ 158,068     $ 138,114       87.4 %

August 2008 convertible notes

    192,000       192,526       (526 )     -0.3 %

December 2008 convertible notes

    516,383       546,980       (30,597 )     -5.6 %

September 2009 secured convertible debentures

    54,962       87,238       (32,276 )     -37.0 %

General interest

    141,598       193,212       (51,614 )     -26.7 %

Related party notes payable

    165,995       161,878       4,117       2.5 %

Total

  $ 1,367,120     $ 1,339,902     $ 27,218       2.0 %

 

We evaluate the cost of capital available to us in combination with our overall capital structure and the prevailing market conditions in deciding what financing best fulfills our short -term and long-term capital needs. Given the overall economic climate and in particular the difficulties nano-cap companies have experienced in obtaining financing, we believe the structure and terms of the transactions we entered into during 2017 and 2016 were obtained at the best terms available to the Company.

 

We record gains/losses related to changes in our derivative liabilities associated with the issuance of convertible debt and warrants that occurred during fiscal 2008 and 2009 and warrants associated with the issuance of promissory notes.  We recorded a net realized gain of $48,375 and a net unrealized gain of $747,404 during the year ended December 31, 2017 compared to a net realized gain of $29,108 and a net unrealized loss of $2,687,018 during the year ended December 31, 2016.  The unrealized gains/losses can be attributed to fair value calculations undertaken periodically on the warrant and conversion feature liabilities recorded by us at the time the convertible debt and warrants were issued.  Accordingly the warrant and conversion feature liabilities are increased or decreased based on the fair value calculations made at each balance sheet date.  This non-cash gain has materially impacted our results of operations during the year ended December 31, 2017 and can be reasonably anticipated to materially affect our net loss or net income in future periods. We are, however, unable to estimate the amount of such income/expense in future periods as the income/expense is partly based on the market price of our common stock at the end of a future measurement date. In addition, if we issue securities which are classified as derivatives we will incur expense and income items in future periods. Investors are cautioned to consider the impact of this non-cash accounting treatment on our financial statements.

 

 

As of December 31, 2017, the Company had cumulative arrearages for preferred stock dividends as follows:

 

Series of Preferred Stock

 

Cumulative Arrearage

 

Series B

  $ 609,887  

Series C

    1,472,093  

Total preferred stock arrearages

  $ 2,081,980  

 

Liquidity and Capital Resources

 

Liquidity is the ability of a company to generate adequate amounts of cash to meet its needs for cash.    We have historically experienced negative cash flows and have relied on the proceeds from the sale of debt and equity securities to fund our operations. In addition, we have utilized stock-based compensation as a means of paying for consulting and salary related expenses. At December 31, 2017, we had working capital deficit of approximately $6,462,136.

 

The table provided below summarizes key measures of our liquidity and capital resources:

 

Liquidity and Capital Resources

 

Summarized Balance Sheet Disclosure

 
   

December 31, 2017

   

December 31, 2016

   

$ Change

   

% Change

 

Cash

  $ 1,176,551     $ 1,439,332     $ (262,781 )     -18.3 %

Accounts receivable, net of allowance for doubtful accounts

    7,492,597       5,455,210       2,037,387       37.3 %

Prepaid expenses

    297,131       195,915       101,216       51.7 %

Prepaid stock compensation, current portion

    -0-       148,422       (148,422 )     -100.0 %

Other current assets

    11,463       35,055       (23,592 )     -67.3 %

Current assets

    8,977,742       7,273,934       1,703,808       23.4 %
                                 

Accounts payable and accrued expenses

    2,586,045       2,123,073       462,972       21.8 %

Patent litigation settlement liability, current portion

    112,500       862,500       (750,000 )     -87.0 %

Deferred revenue, current portion

    7,564,587       7,250,061       314,526       4.3 %

Convertible notes payable, current portion, net of discount

    50,000       50,000       -0-       0.0 %

Conversion feature liability, related parties

    1,604,723       1,740,278       (135,555 )     -7.8 %

Conversion feature liability

    81,224       585,452       (504,228 )     -86.1 %

Warrant liability, related parties

    2,196,570       2,519,614       (323,044 )     -12.8 %

Warrant liability

    1,244,229       1,479,748       (235,519 )     -15.9 %

Current liabilities

    15,439,878       16,610,726       (1,170,848 )     -7.0 %
                                 

Working capital (deficit)

  $ (6,462,136 )   $ (9,336,792 )   $ 2,874,656       30.8 %

 

Cash and Cash Equivalents

 

Cash and cash equivalents decreased to $1,176,551 at December 31, 2017 from $1,439,332 at December 31, 2016. The decrease is primarily comprised of net income of $2,967,218, offset by non-cash transactions of $557,421, changes in working capital accounts of ($2,658,757), investment activities of ($242,384) and financing transactions of ($879,750).

 

Capital Expenditures

 

We are not currently bound by any long -term or short-term agreements for the purchase or lease of capital expenditures. Any amounts expended for capital expenditures would be the result of an increase in the capacity needed to adequately service any increase in our business. To date we have paid for any needed additions to our capital equipment infrastructure from working capital funds and anticipate this being the case in the future.

 

Presently, we have approximately $1,000,000 planned for capital expenditures to further develop the Company’s infrastructure to allow for growth in our operations over the next 12 months.  We expect to fund these capital expenditure needs through a combination of vendor-provided financing, the use of operating or capital equipment leases and cash provided from operations.

 

 

Contractual Obligations

 

The following table sets forth our contractual obligations as of December 31, 2017:

 

Contractual obligation

   

Payments due by period

         
   

Total

   

Less than 1 year

   

1-2 Years

   

2-3 Years

   

3+ Years

 

Promissory notes (1)

  $ 1,102,500     $ -0-     $ 400,000  (2)   $ 702,500  (3)   $ -0-  

Convertible notes (1)

    6,170,000       50,000  (4)     150,000  (5)     5,770,000  (6)     200,000  (7)

Lines of credit (8)

    2,650,000       -0-       -0-       2,650,000       -0-  

Operating lease obligations (9)

    2,046,812       651,376       475,638       339,287       580,511  (10)

Patent licensing fees (11)

    112,500       112,500       -0-       -0-       -0-  

Total

  $ 12,081,812     $ 813,876     $ 1,025,638     $ 9,461,787     $ 780,511  

 

1.

Amounts do not include interest to be paid.

2.

Includes $400,000 in 12% notes payable that mature in April 2019.

3.

Includes $420,000 in 10% notes payable that mature in April 2020 and $282,500 in 12% notes payable that mature in April 2020.

4.

Includes $50,000 in 10% convertible notes currently in default and due that are convertible into shares of common stock at the option of the holder at a conversion rate of $1.25 per share.

5.

Includes $150,000 in 10% convertible notes that mature in April 2019.

6.

Includes $1,770,000 in 10% convertible notes that mature in April 2020 and $4,000,000 in 12% convertible notes that mature in April 2020.

7.

Includes $200,000 in 12% convertible notes that mature in April 2021.

8.

Includes $2,650,000 due on the revolving Line of Credit with The Northern Trust Company.

9.

Includes office lease obligations for our corporate office in Florida, our regional operating office in New Jersey, our co-location and disaster recovery locations in Ohio, Florida and Germany, our office in England, our office in the Netherlands and our European headquarters in Germany.

10.

Includes office lease obligations through 2023.

11.

Relates to guaranteed minimum payments owed in connection with our settlement of a patent infringement lawsuit brought against the Company by DataSci, LLC.

 

Off Balance Sheet Arrangements

 

We have no off balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.

 

Debt Obligations

 

As of December 31, 2017, we were in default on principal and interest payments totaling $143,210 on our 10% Convertible Notes that were issued in 1999.

 

On February 29, 2016, the Company issued a promissory note in the principal amount of $450,000 and warrants to purchase 1,800,000 shares of common stock of the Company at an exercise price of $0.25 per share with an expiration date of April 1, 2019 to Cornelis F. Wit, our then Chief Executive Officer and director, ("Mr. Wit") in exchange for accrued interest in the amount of $450,000.  The note carries an interest rate of 12% per annum and has a maturity date of April 1, 2019. On August 31, 2017, the Company repaid $50,000 to Mr. Wit.

 

On June 30, 2016 the Company and Mr. Wit extended the maturity date of $4,055,000 of convertible debentures originally issued in December 2008.  The debentures carry an interest rate of 12% and have a maturity date of April 1, 2020.  The expiration date of the warrants associated with the debentures was also extended to April 1, 2020. On August 31, 2017, the Company repaid $55,000 to Mr. Wit.

 

On June 30, 2016 the Company and Mr. Wit extended the maturity date of $1,770,000 of convertible debentures to Mr. Wit  originally issued in August 2008.  The debentures carry an interest rate of 10% and have a maturity date of April 1, 2020.  The expiration date of the warrants associated with the debentures was also extended to April 1, 2020.

 

On June 30, 2016, the Company issued promissory notes in the principal amount of $420,000 and warrants to purchase 1,680,000 shares of common stock of the Company at an exercise price of $0.25 per share with an expiration date of April 1, 2020 to two investors, in exchange for existing promissory notes in the same amount.  The notes carry an interest rate of 10% per annum and have a maturity date of April 1, 2020.

 

On June 30, 2016 the Company and our former director, Mr. van Kesteren (“Mr. van Kesteren") extended the maturity date of $150,000 of convertible debentures originally issued in August 2008. The debentures carry an interest rate of 10% and have a maturity date of April 1, 2018. The expiration date of the warrants associated with the debentures was also extended to April 1, 2018. On June 30, 2017 the Company and Mr. van Kesteren extended the maturity date of his $150,000 of convertible debentures to April 1, 2019. The expiration date of the warrants associated with the debentures was also extended to April 1, 2019.

 

On June 30, 2016, the Company issued promissory notes in the principal amount of $372,500 and warrants to purchase 1,490,000 shares of common stock of the Company at an exercise price of $0.25 per share with an expiration date of April 1, 2020 to two investors, in exchange for existing promissory notes in the same amount.  The notes carry an interest rate of 12% per annum and have a maturity date of April 1, 2020. On August 31, 2017, the Company repaid $90,000 to one of the lenders.

 

On April 7, 2017 the Company renewed the $5,000,000 Line of Credit from The Northern Trust Company ("Line of Credit"). The Line of Credit matures on April 7, 2020 and carries a variable interest rate based on the prime rate. At December 31, 2017, $2,650,000 was outstanding on the Line of Credit at an interest rate of 3.5%.

 

 

On June 30, 2017, the Company and the holder extended the maturity date of $200,000 of convertible debentures originally issued in December 2008.  The debentures carry an interest rate of 12% and have a maturity date of April 1, 2021.  The expiration date of the warrants associated with the debentures was also extended to April 1, 2021.

 

During the next twelve months we expect debt in the aggregate amount of $5 0,000 to mature as follows:  $50,000 of 10% convertible notes currently in default and due that are convertible into shares of common stock at the option of the debenture holder at a conversion rate of $1.25 per share.

 

Sources of Liquidity and Capital Resources

 

Because of the historical losses we have experienced from operations we have needed to continue utilizing the proceeds from the sale of debt and equity securities to fund our working capital needs. We have used a combination of equity financing, short-term bridge loans and long-term loans to fund our working capital needs. Other than our revenues, revolving Line of Credit in the amount of $5,000,000, current capital and capital we may raise from future debt or equity offerings or short-term bridge loans, we do not have any additional sources of working capital. In the event that the Line of Credit is called for any reason, Mr. Wit has pledged to replace the borrowing capacity under the Line of Credit with a promissory note that utilizes the same maturity date and interest rate as the Line of Credit.

 

In 2017 the Company repaid $50,000 on the Line of Credit. In 2016 the Company repaid $1,500,000 on the Line of Credit. As of December 31, 2017, the Company had $2,650,000 in outstanding borrowings under the Line of Credit.    

 

We may continue to require substantial funds to continue our research and product development activities and to market, sell and commercialize our technology. We may need to raise substantial additional capital to fund our future operations. Our capital requirements will depend on many factors, including the problems, delays, expenses and complications frequently encountered by companies developing and commercializing new technologies; the progress of our research and product development activities; the rate of technological advances; determinations as to the commercial potential of our technology under development; the status of competitive technology; the establishment of collaborative relationships; the success of our sales and marketing programs; the cost of filing, prosecuting, defending and enforcing intellectual property rights; and other changes in economic, regulatory or competitive conditions in our planned business.  Estimates about the adequacy of funding for our activities are based upon certain assumptions, including assumptions that the research and product development programs relating to our technology can be conducted at projected costs and that progress towards broader commercialization of our technology will be timely and successful. There can be no assurance that changes in our research and product development plans or other events will not result in accelerated or unexpected expenditures.

 

To satisfy our capital requirements, including ongoing future operations, we may seek to raise additional financing through debt and equity financings. There can be no assurance that any such funding will be available to us on favorable terms or at all. If adequate funds are not available when needed, we may be required to delay, scale back or eliminate some or all of our research and product development programs, and our business operations. If we are successful in obtaining additional financings, the terms of such financings may have the effect of diluting or adversely affecting the holdings or the rights of the holders of our common and preferred stock. Further, there can be no assurance that even if such additional capital is obtained or the planned cost reductions are implemented, that we will achieve positive cash flow or profitability or be able to continue as a business.

 

While several of our officers and directors have historically, either personally or through funds with which they are affiliated, provided substantial capital either in the form of debt or equity financing there can be no assurance that they will continue to provide any such funding to us on favorable terms or at all.

 

CRITICAL ACCOUNTING POLICIES

 

The preparation of financial statements and related disclosures in conformity with accounting principles generally accepted in the United States requires management to make judgments, assumptions and estimates that affect the amounts reported. Note 2 of Notes to the Consolidated Financial Statements describes the significant accounting policies used in the preparation of the consolidated financial statements. Certain of these significant accounting policies are considered to be critical accounting policies, as defined below.

 

A critical accounting policy is defined as one that is both material to the presentation of our financial statements and requires management to make difficult, subjective or complex judgments that could have a material effect on our financial condition and results of operations. Specifically, critical accounting estimates have the following attributes: 1) we are required to make assumptions about matters that are highly uncertain at the time of the estimate; and 2) different estimates we could reasonably have used, or changes in the estimate that are reasonably likely to occur, would have a material effect on our financial condition or results of operations.

 

 

Estimates and assumptions about future events and their effects cannot be determined with certainty. We base our estimates on historical experience and on various other assumptions believed to be applicable and reasonable under the circumstances. These estimates may change as new events occur, as additional information is obtained and as our operating environment changes. These changes have historically been minor and have been included in the consolidated financial statements as soon as they became known. In addition, our Management is periodically faced with uncertainties, the outcomes of which are not within our control and will not be known for prolonged periods of time.   Based on a critical assessment of its accounting policies and the underlying judgments and uncertainties affecting the application of those policies, our Management believes that our consolidated financial statements are fairly stated in accordance with accounting principles generally accepted in the United States ("GAAP"), and present a meaningful presentation of our financial condition and results of operations.

 

Our Management believes that the following are our critical accounting policies:

 

ASSET IMPAIRMENT

 

Asset Acquisitions , Goodwill and Intangible Assets

 

We account for asset acquisitions in accordance with ASC 350, Intangibles- Goodwill and Other Intangible Assets . The acquisition method of accounting requires that assets acquired and liabilities assumed be recorded at their fair values on the date of an asset acquisition.

 

The judgments that we make in determining the estimated fair value assigned to each class of assets acquired and liabilities assumed, as well as asset lives, can materially impact net income in periods following an asset acquisition. We generally use either the income, cost or market approach to aid in our conclusions of such fair values and asset lives. The income approach presumes that the value of an asset can be estimated by the net economic benefit to be received over the life of the asset, discounted to present value. The cost approach presumes that an investor would pay no more for an asset than its replacement or reproduction cost. The market approach estimates value based on what other participants in the market have paid for reasonably similar assets. Although each valuation approach is considered in valuing the assets acquired, the approach ultimately selected is based on the characteristics of the asset and the availability of information.

 

Goodwill is evaluated for impairment using a two-step process that is performed at least annually or when circumstances indicate that an impairment may exist. The first step is a qualitative measure. If this first test is passed, the second step is not necessary. If the book value exceeds the fair value, then the second, quantitative test is performed to measure the impairment loss .

 

Long Lived Assets

 

We review long-lived assets for impairment whenever events or changes in circumstances indicate that the related carrying amounts may not be recoverable. Determining whether an impairment has occurred typically requires various estimates and assumptions, including determining which cash flows are directly related to the potentially impaired asset, the useful life over which cash flows will occur, their amount and the asset ’s residual value, if any. In turn, measurement of an impairment loss requires a determination of fair value, which is based on the best information available. We use quoted market prices when available and independent appraisals, as appropriate, to determine fair value.

 

DEFERRED REVENUE

 

Deferred revenue represents cash advances received in excess of revenue earned on on-going contracts.   Payment terms vary with each contract but may include an initial payment at the time the contract is executed, with future payments dependent upon the completion of certain contract phases or targeted milestones.  In the event of contract cancellation, the Company is generally entitled to payment for all work performed through the point of cancellation.

 

REVENUE RECOGNITION POLICY

 

OmniComm ’s revenue model is transaction-based and can be implemented either as an Application Service Provider (“ASP”) or licensed for implementation by a customer.  Revenues are derived from the set-up of clinical trial engagements; licensing arrangements, fees earned for hosting our clients’ data and projects, on-going maintenance fees incurred throughout the duration of an engagement; fees for report writing and project change orders.  The clinical trials that are conducted using our EDC Applications can last from a few months to several years.  Most of the fees associated with our product including post-setup customer support in the form of maintenance charges are recognized ratably over the term of clinical trial projects.  Cost of goods sold is primarily comprised of salaries and taxes and is expensed as incurred.

 

 

The Company recognizes revenues, for both financial statement and tax purposes in accordance with SEC Staff Accounting Bulletin No. 104 “Revenue Recognition in Financial Statements (SAB 104)” (Codified within Accounting Standards Codification (ASC) Revenue Recognition ASC 605) and AICPA Statement of Position 97-2 (SOP 97-2) “Software Revenue Recognition” as amended by SOP 98-9 (Codified within ASC 605.985, Software Industry Revenue Recognition). SAB 104 requires that revenues be recognized ratably over the life of a contract.  The Company will periodically record deferred revenues relating to advance payments in contracts.  Under its licensing arrangements the Company recognizes revenue pursuant to SOP 97-2.  Under these arrangements the Company recognizes revenue when all of the following conditions are satisfied: (1) there is persuasive evidence of an arrangement; (2) the service has been provided to the customer and/or delivery has occurred; (3) the collection of fees is probable; and (4) the fee is fixed or determinable.  SOP 97-2, as amended, requires revenue earned on software arrangements involving multiple elements to be allocated to each element based on the relative fair values of the elements.  We have analyzed each element in our multiple element arrangements and determined that we have sufficient vendor-specific objective evidence (“VSOE”) to allocate revenues to license updates and product support.  License revenues are recognized on delivery if the other conditions of SOP 97-2 are satisfied.  License updates and product support revenue is recognized ratably over the term of the arrangement. In arrangements where term licenses are bundled with license updates and product support and such revenue is recognized ratably over the term of the arrangement, we allocate the revenue to license revenue and to license updates and product support revenue based on the VSOE of fair value for license updates and product support revenue on perpetual licenses of similar products.

 

STOCK BASED COMPENSATION.

 

The Company accounts for its employee equity incentive plans under ASC 718, Compensation – Stock Compensation which addresses the accounting for transactions in which an entity exchanges its equity instruments for goods or services, with a primary focus on transactions in which an entity obtains employee services in share-based payment transactions.

 

ASC 718 requires companies to estimate the fair value of share-based payment awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods in the Company ’s Consolidated Statements of Operations. The Company currently uses the Black-Scholes option pricing model to determine grant date fair value.

 

EFFECT OF RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS

 

During fiscal 2017, we adopted the following new accounting pronouncements:

 

In February 2016, the FASB issued accounting standard update (“ ASU”) No. 2016-02, “Leases (Topic 842)” , (“ASU 2016-02”). This ASU requires that an entity should recognize assets and liabilities for leases with a maximum possible term of more than 12 months. A lessee would recognize a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the leased asset (the underlying asset) for the lease term. This guidance also provides accounting updates with respect to lessor accounting under a lease arrangement. This new lease guidance is effective for fiscal years beginning after December 15, 2019. Entities have the option of using either a full retrospective or a modified approach (cumulative effect adjustment in period of adoption) to adopt the new guidance. Early adoption is permitted for all entities. We are currently evaluating the impact of the adoption of this guidance in our consolidated financial statements.

 

In March 2016, April 2016, and December 2016, the FASB issued ASU 2016-08, " Revenue from Contracts with Customers - Principal versus Agent Considerations (Reporting Revenue Gross versus Net) ", (“ASU 2016-08”), ASU 2016-10, " Revenue from Contracts with Customers - Identifying Performance Obligations and Licensing ", (“ASU 2016-10”), and ASU 2016-20, " Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers" , (“ASU 2016-20”) respectively, which further clarify the guidance for those specific topics within ASU 2014-09. In May 2016, the FASB issued ASU 2016-12, " Revenue from Contracts with Customers - Narrow Scope Improvements and Practical Expedients ", to reduce the risk of diversity in practice for certain aspects in ASU 2014-09, including collectability, noncash consideration, and transition. These updates permit the use of either the retrospective or cumulative effect transition method. Early application is permitted for annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. 

 

In July 2017, The Financial Accounting Standards Board issued Accounting Standards Update 2017-11 “ Earnings per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815) ” (“ASU 2017-11”) This ASU addresses narrow issues identified as a result of the complexity associated with applying generally accepted accounting principles (GAAP) for certain financial instruments with characteristics of liabilities and equity. Part I of the amendment change the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features. The amendments also clarify existing disclosure requirements for equity-classified instruments. Part II of the update recharacterize the indefinite deferral of certain provisions of Topic 480 that now are presented as pending content in the Codification, to a scope exception. Those amendments do not have an accounting effect. Part I of ASU 2017-11 is effective for public business entities for fiscal years, and interim period within those fiscal years, beginning after December 15, 2018, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU-2017-11.

 

Accounting standards-setting organizations frequently issue new or revised accounting rules. We regularly  review all new pronouncements that have been issued since the filing of our Form 10K for the year ended December 31, 2017 to determine their impact, if any, on our financial statements.

 

 

ITEM 7A.        QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable to smaller reporting companies.

 

ITEM 8.           FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 

Our financial statements are set forth on Pages F-1 through F-36 attached hereto.

 

ITEM 9.           CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

 

None.

 

ITEM 9A.        CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

Based on their evaluation as of the end of the period covered by this Annual Report, being December 31, 2017, the Company’s principal executive officer and principal financial officer have concluded that the Company’s disclosure controls and procedures as defined in  Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) are effective such that the information relating to OmniComm, including our consolidating subsidiaries, required to be disclosed by the Company in reports that it files or submits under the Exchange Act (1) is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms, and (2) is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.

 

Management ’s Report on Internal Control over Financial Reporting

 

Management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

 

Management assessed the effectiveness of OmniComm ’s internal control over financial reporting as of December 31, 2017. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control-Integrated Framework (2017). Based on the assessment using those criteria, management concluded that our internal control over financial reporting was effective as of December 31, 2017 to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles.

 

Changes in Internal Control over Financial Reporting

 

There have been no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act, during the fourth quarter ended December 31, 2017 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

It should be noted that any system of controls, however well designed and operated, can provide only reasonable, and not absolute, assurance that the objectives of the system are met. In addition, the design of any control system is based in part upon certain assumptions about the likelihood of future events. Because of these and other inherent limitations of control systems, there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote.

 

ITEM 9B.        OTHER INFORMATION

 

None.

 

 

PART III

 

ITEM 10.         DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

 

The information required in response to this item is incorporated by reference from the information contained in the sections “Nominees for the Board of Directors,” “Management,” “Compliance with Section 16(a) of the Exchange Act,” and “Equity Compensation Plan Information,” in our Proxy Statement for our 2018 Annual Meeting of Stockholders to be held on June 7, 2018 (the “Proxy Statement”).

 

ITEM 11.         EXECUTIVE COMPENSATION

 

The information required in response to this item is incorporated by reference from the information contained in the section captioned “Executive Compensation” in the Proxy Statement.

 

ITEM 12.         SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

 

The information required in response to this item is incorporated by reference from the information contained in the section captioned “Security Ownership of Certain Beneficial Owners and Management” in the Proxy Statement.   The information required by Item 201(d) of Regulation S-K is incorporated by reference from the information contained in the section captioned “Executive Compensation, Equity Compensation Plan Information” in the Proxy Statement.

 

ITEM 13.         CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS; AND DIRECTOR INDEPENDENCE

 

The information required in response to this item is incorporated by reference from the information contained in the section s captioned “Management” and “Certain Relationships and Related Party Transactions” in the Proxy Statement.

 

ITEM 14.         PRINCIPAL ACCOUNTING FEES AND SERVICES

 

The information required in response to this item is incorporated by reference from the information contained in the section captioned “Ratification of the Appointment of Liggett & Webb, P.A. as our independent registered public accounting firm” in the Proxy Statement.

 

PART IV

 

ITEM 15.         EXHIBITS, FINANCIAL STATEMENT SCHEDULES

 

The following documents are filed as a part of this report or are incorporated by reference to previous filings, if so indicated:

 

(a )            Exhibits

 

 

  INCORPORATED BY REFERENCE

 

EXHIBIT NO.

DESCRIPTION

FORM EXHIBIT DATE FILED

2.1

Agreement and Plan of Reorganization (acquisition of OmniComm Systems, Inc.) dated July 22, 1998 (Pursuant to Item 601(b)(2) of Regulation S-K, certain exhibits and or schedules have not been filed. The Company hereby agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request.) 

8-K (File No. 000-25203) 2 03/03/1999

2.2

Amendment to Agreement and Plan of Reorganization dated November 3, 1998

10-SB (File No. 000-25203) 2(c) 12/22/1998

2.3

Agreement and Plan of Merger (acquisition of Education Navigator, Inc. by OmniComm Systems, Inc.) dated June 26, 1998

10-SB/A (File No. 000-25203) 2(c) 07/27/1999

3.1

Certificate of Incorporation (1)

SB-2 (File No. 333-06410) 3(a) 02/06/1997

3.2

Certificate of Merger

10-K (File No. 000-25203) 3.2 03/30/2016

3.3

Certificate of Amendment – Certificate of Incorporation

10-SB/A (File No. 000-25203) 4(a) 07/27/1999

3.4

Certificate of Designation – Series A Preferred Stock

10-SB/A (File No. 000-25203) 4(b) 08/25/1999

3.5

Certificate of Increase – Series A Preferred Stock

10-KSB (File No. 000-25203) 4(c) 03/29/2000

3.6

Certificate of Designation –Series B Preferred Stock

SB-2/A (File No. 333-45640) 4(d) 09/17/2001

3.7

Certificate of Amendment – Certificate of Incorporation

SB-2 (File No. 333-76016) 4(e) 12/27/2001

3.8

By-laws (2)

SB-2 (File No. 333-06410) 3(b) 02/06/1997

3.9

Certificate of Correction – Certificate of Designation – Series B Preferred Stock

10-K (File No. 000-25203) 3.9 03/30/2016

3.10

Certificate of Amendment – Certificate of Designation – Series A Preferred Stock

10-K (File No. 000-25203)

3.10

03/30/2016

3.11

Certificate of Amendment – Certificate of Incorporation

10KSB (File No. 000-25203) 3.8 04/15/2003

3.12

Certificate of Designation – Series C  Preferred Stock

10KSB (File No. 000-25203) 3.9 04/15/2003

3.13

Certificate of Correction – Certificate of Designation – Series A Preferred Stock

10-K (File No. 000-25203) 3.13 03/30/2016

3.14

Certificate of Amendment – Certificate of Incorporation

DEF 14A (File No. 000-25203) A 06/16/2009

3.15

Certificate of Designation – Series D Preferred Stock

8-K (File No. 000-25203) 3.10 11/30/2010

3.16

Certificate of Amendment – Certificate of Designation – Series A Preferred Stock

10-QSB (File No. 000-25203) 3.11 11/13/2015

 

 

EXHIBIT NO. DESCRIPTION FORM EXHIBIT DATE FILED

4.1

Form of 10% Convertible Note

SB-2 (File No. 333-109231) 4.3 09/29/2003

4.2

Notice on requests for non-material agreements

10-K (File No. 000-25203) 4.2 03/31/2015

4.3

Amended and Restated Master Note payable to The Northern Trust Company dated April 7, 2017

10-Q (File No. 000-25203) 4.3 08/11/2017

4.4

Pledge Agreement between The Northern Trust Company and Cornelis F. Wit Revocable Trust dated April 7, 2017

10-Q (File No. 000-25203) 4.4 08/11/2017

4.5

Securities Account Control Agreement between The Northern Trust Company and Cornelis F. Wit Revocable Trust dated April 7, 2017

10-Q (File No. 000-25203) 4.5 08/11/2017

10.1   ø

1998 Stock Incentive Plan

10-SB/A (File No. 000-25203) 10(c) 07/27/1999

10.2   ø

Employment Agreement and Stock Option Agreement between the Company and Cornelis F. Wit

10-QSB (File No. 000-25203) 10.7 08/12/2002

10.3   ø

Amendment to Employment Agreement between the Company and Cornelis F. Wit

SB-2 (File No. 333-109231) 10.8 09/29/2003

10.4   ø

Employment Agreement between the Company and Randall G. Smith

10-QSB (File No. 000-25203) 10.9 11/12/2004

10.5

Lease Agreement (Fort Lauderdale, Florida, for principal executive offices of U.S. Headquarters) dated March 24, 2006 between OmniComm Systems, Inc. and RFP Mainstreet 2101 Commercial, LLC (Pursuant to Item 601(b)(2) of Regulation S-K, certain exhibits and or schedules have not been filed. The Company hereby agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request.)

10-QSB (File No. 000-25203) 10.1 08/14/2006

10.6   ø

Employment Agreement and Stock Option Agreement between the Company and Stephen E. Johnson dated September 4, 2006

10-QSB (File No. 000-25203) 10.1 11/14/2006

10.7

Securities Purchase Agreement dated August 29, 2008 by and between OmniComm Systems, Inc. and each individual or entity named on an executed counterpart of the signature page thereto

10-K (File No. 000-25203) 10.7 03/30/2016

10.8

Form of Debenture dated August 29, 2008

10-K (File No. 000-25203) 4.8 04/14/2009

10.9

Form of Warrant dated August 29, 2008

10-K (File No. 000-25203) 4.9 04/14/2009

10.10

Securities Purchase Agreement dated December 16, 2008 by and between OmniComm Systems, Inc. and each individual or entity named on an executed counterpart of the signature page thereto

8-K (File No. 000-25203) 10.1 12/17/2008

10.11

Form of Debenture dated December 16, 2008

8-K (File No. 000-25203) 10.2 12/17/2008

10.12

Form of Warrant December 16, 2008

8-K (File No. 000-25203) 10.3 12/17/2008

10.13

Settlement and Licensing Agreement with DataSci, LLC effective date April 2, 2009

10-K (File No. 000-25203) 10.13 03/30/2016

10.14

Asset Purchase Agreement with eResearch Technology, Inc. dated June 23, 2009 (Pursuant to Item 601(b)(2) of Regulation S-K, certain exhibits and or schedules have not been filed. The Company hereby agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request.)

8-K (File No. 000-25203) 10.26 06/26/2009

10.15

First Amendment to Settlement and Licensing Agreement with DataSci, LLC dated June 22, 2009

10-K (File No. 000-25203) 10.15 03/30/2016

10.16

Agreement by and between OmniComm, Ltd. and Logos Technologies, Ltd dated August 3, 2009 (Pursuant to Item 601(b)(2) of Regulation S-K, certain exhibits and or schedules have not been filed. The Company hereby agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request.)

8-K (File No. 000-25203) 10.29 08/04/2009

10.17

Securities Purchase Agreement dated September 30, 2009 by and between OmniComm Systems, Inc. and each individual or entity named on an executed counterpart of the signature page thereto

8-K (File No. 000-25203) 10.1 10/05/2009

10.18

Form of Debenture dated September 30, 2009

8-K (File No. 000-25203) 10.2 10/05/2009

10.19

Form of Warrant dated September 30, 2009

8-K (File No. 000-25203) 10.3 10/05/2009

10.20

Form of Security Interest Agreement dated September 30, 2009

8-K (File No. 000-25203) 10.4 10/05/2009

10.21

Securities Purchase Agreement dated December 31, 2009 by and between OmniComm Systems, Inc. and each individual or entity named on an executed counterpart of the signature page thereto

10-K (File No. 000-25203) 10.22 03/31/2015

10.22

Form of Debenture dated December 31, 2009

10-K (File No. 000-25203) 10.23 03/31/2015

10.23

Form of Warrant dated December 31, 2009

10-K (File No. 000-25203) 10.24 03/31/2015

10.24

Subscription Agreement for the Series D Preferred Stock dated November 30, 2010 by and between OmniComm Systems, Inc. and Cornelis F. Wit

8-K (File No. 000-25203) 10.32 11/30/2010

10.25   ø

2009 Equity Incentive Plan and form of stock option agreement relating thereto

DEF 14A (File No. 000-25203) B 06/16/2009

10.26   ø

Form of Restricted Stock Agreement used for grants of restricted stock under the 2009 Equity Incentive Plan

10-K (File No. 000-25203) 10.76 03/31/2015

10.27

Amendment Number One to Securities Purchase Agreement dated September 30, 2009 between the Company and Cornelis F. Wit dated March 30, 2011

10-Q (File No. 000-25203) 10.85 05/15/2015

10.28

Amendment Number Two to Securities Purchase Agreement between the Company and the  Leonard and Janine Epstein 2012 Revocable Trust dated February 22, 2013

10-K (File No. 000-25203) 10.58 03/27/2013

10.29

Amendment Number Two to Securities Purchase Agreement between the Company and  Cornelis F. Wit dated February 22, 2013

10-K (File No. 000-25203) 10.59 03/27/2013

10.30

Amendment Number Two to Securities  Purchase Agreement between the Company and Richard & Carolyn Danzansky dated February 22, 2013

10-K (File No. 000-25203) 10.60 03/27/2013

10.31

Amendment Number Two to Securities Purchase Agreement between the Company and  Paul Spitzberg dated February 22, 2013

10-K (File No. 000-25203) 10.61 03/27/2013

10.32

Amendment Number Two to Securities Purchase Agreement between the Company and  Cornelis F. Wit dated February 22, 2013

10-K (File No. 000-25203) 10.62 03/27/2013

10.33

Share Purchase Agreement (acquisition of Promasys B. V.) dated November 11, 2013 (Pursuant to Item 601(b)(2) of Regulation S-K, certain exhibits and or schedules have not been filed. The Company hereby agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request.)

10-Q (File No. 000-25203) 10.71 11/13/2013

 

 

EXHIBIT NO. DESCRIPTION FORM EXHIBIT DATE FILED

10.34

Lease Agreement Office Accommodation (Leiden, Netherlands, for Promasys B.V.) dated November 1, 2013

10-Q (File No. 000-25203) 10.72 11/13/2013

10.35

Amendment Number Three to Securities Purchase Agreement dated September 30, 2009 between the Company and  Cornelis F. Wit dated January 31, 2015

10-K (File No. 000-25203) 10.67 03/31/2015

10.36

Amendment Number Three to Securities Purchase Agreement dated December 31, 2009 between the Company and  Cornelis F. Wit dated January 31, 2015

10-K (File No. 000-25203) 10.68

03/31/2015

10.37

Warrant agreement with Cornelis F. Wit dated January 31, 2015

10-K (File No. 000-25203) 10.72 03/31/2015

10.38

Amendment Number Three to Securities Purchase Agreement dated September 30, 2009 between the Company and Leonard and Janine Epstein Revocable Trust dated April 1, 2015

10-Q (File No. 000-25203) 10.77 05/15/2015

10.39

Amendment Number Three to Securities Purchase Agreement dated December 31, 2009 between the Company and Richard & Carolyn Danzansky dated April 1, 2015

10-Q (File No. 000-25203) 10.78 05/15/2015

10.40

Amendment Number Three to Securities Purchase Agreement dated December 31, 2009 between the Company and Paul Spitzberg dated April 1, 2015

10-Q (File No. 000-25203) 10.80 05/15/2015

10.41

Pledgor Fee and Reimbursement Agreement with Cornelis F. Wit  dated August 13, 2015

10-Q (File No. 000-25203) 10.88 11/13/2015

10.42

Third Amendment to Lease Agreement (Fort Lauderdale, Florida, for principal executive offices of U.S. Headquarters)  dated September 16, 2010

10-K (File No. 000-25203) 10.42 03/30/2016

10.43

Fourth Amendment to Lease Agreement (Fort Lauderdale, Florida, for principal executive offices of U.S. Headquarters) dated May 29, 2015

10-K (File No. 000-25203) 10.43 03/30/2016

10.44

Lease Agreement (Monmouth Junction, New Jersey) dated  August 12, 2009

10-K (File No. 000-25203) 10.44 03/30/2016

10.45

First Amendment of Lease Agreement (Monmouth Junction, N.J.) dated February 28, 2013

10-K (File No. 000-25203) 10.45 03/30/2016

10.46

Lease Agreement (Bonn, Germany) dated August 1, 2012

10-K (File No. 000-25203) 10.46 03/30/2016

10.47

Lease Agreement (Southampton, United Kingdom) dated September 6, 2012

10-K (File No. 000-25203) 10.47 03/30/2016

10.48  †

Form of Promissory Note and Schedule of Substantially Identical Promissory Notes

10-Q (File No. 000-25203) 10.47 11/13/2017

10.49  †

Form of Extension of Maturity Date of Convertible Debenture and Related Warrants and Schedule of Substantially Identical Extensions of Maturity Date of Convertible Debenture and Related Warrants

10-Q (File No. 000-25203) 10.48 11/13/2017

10.50  †

Form of Extension of Maturity Date of Warrants and Schedule of Substantially Identical Extensions of Maturity Date of Warrants

10-K (File No. 000-25203) 10.50 03/30/2016

10.51

Warrant Termination Agreement with Cornelis F. Wit dated November 19, 2015

10-K (File No. 000-25203) 10.51 03/30/2016

10.52   ø

Amendment No. 2 to Executive Employment Agreement dated April 15, 2016 with Cornelis F. Wit

10-Q (File No. 000-25203) 10.52 05/16/2016

10.53   ø

Amendment No. 1 to Executive Employment Agreement dated April 15, 2016 with Stephen E. Johnson

10-Q (File No. 000-25203) 10.53 05/16/2016

10.54

Form of Common Stock Purchase Warrant and Schedule of Substanially Identical Common Stock Purchase Warrants

10-Q (File No. 000-25203) 10.54 08/11/2017

10.55

Lease Agreement (Somerset, N.J.) dated December 17, 2015

10-Q (File No. 000-25203) 10.55 05/16/2016

10.56 ø

2016 Equity Incentive Plan and form of stock option agreement and form or restricted stock award agreement relating thereto

DEF 14A (File No. 000-25203) A 04/29/2016

10.57 ø

Employment Agreement between the Company and Thomas E. Vickers dated March 14, 2017

8-K (File No. 000-25203) 10.1 03/15/2017

10.58 ø

Amendment No. 1 to Executive Employment Agreement between the Company and Randall G. Smith dated March 14, 2017

8-K (File No. 000-25203) 10.2 03/15/2017
10.59 Lease Agreement Extension (Southampton, United Kingdom) dated September 10, 2017 10-Q (File No. 000-25203) 10.58 11/13/2017

14

OmniComm Systems, Inc. Code of Ethics

10-Q (File No. 000-25203) D 05/16/2016

 

 

 

 

 

EXHIBIT NO. DESCRIPTION FORM EXHIBIT DATE FILED

21

Subsidiaries of the Company*

10-K (File No. 000-25203) 2.1 04/02/2018

23

Consent of Liggett & Webb, P.A., independent registered public accounting firm*  

10-K (File No. 000-25203) 23 04/02/2018

31.1

Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, promulgated under the Securities and Exchange Act of 1934, as amended.*

10-K (File No. 000-25203) 31.1 04/02/2018

31.2

Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, promulgated under the Securities and Exchange Act of 1934, as amended.*

10-K (File No. 000-25203) 31.2 04/02/2018

32.1

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002**

     

101.INS

XBRL Instance Document*

     

101.SCH

XBRL Taxonomy Extension Schema Document*

     

101.CAL

XBRL Taxonomy Extension Calculation*

     

101.DEF

XBRL Taxonomy Extension Definition*

     

101.LAB

XBRL Taxonomy Extension Label*

     

101.PRE

XBRL Taxonomy Extension Presentation*

     

 

 

1.

Incorporated by reference to Exhibit 3(a) filed with our Registration Statement on Form SB-2 dated February 6, 1997.
2. Incorporated by reference to Exhibit 3(b) filed with our Registration Statement on Form SB-2 dated February 6, 1997.

 

 

* Filed herewith

**Furnished herewith

ø  Indicates a management contract or compensatory plan or arrangement

† Pursuant to Instruction 2 of Item 601(a) of Regulation S-K, the Company has filed only the form of the contract, and other contracts substantially identical in all material respects, except as to the parties thereto and certain other details, are described in a Schedule to the exhibit.

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Dated: April 2,   2018

 

  OMNICOMM SYSTEMS, INC.
   
  By: /s/ Cornelis F. Wit                     
  Cornelis F. Wit, Executive Chairman
   
   
   
  By: /s/ Thomas E. Vickers                 
  Thomas E. Vickers, Chief Accounting and
  Financial Officer

 

 

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

 

 

Signature

   

Title

   

Date

   

   

   

   

   

/s/ Cornelis F. Wit

   

Principal Executive Officer

   

April 2 , 2018

Cornelis F. Wit

   

and Executive Chairman

   

   

   

   

   

   

   

/s/ Randall G. Smith

   

Executive Vice Chairman

   

April 2 , 2018

Randall G. Smith   

   

   

   

   

   

   

   

   

   

/s/ Thomas E. Vickers

   

Chief (Principal) Accounting and

   

April 2 , 2018

Thomas E. Vickers

   

Financial Officer

   

   

   

   

   

   

   

/s/ Robert C. Schweitzer

   

Director  

   

April 2 , 2018

Robert C. Schweitzer

   

   

   

   

         

/s/ Adam F. Cohen

 

Director

 

April 2 , 2018

Adam F. Cohen

       

   

   

   

   

   

/s/ Gary A. Shangold

   

Director

   

April 2 , 2018

Gary A. Shangold

   

   

   

   

 

 

OMNICOMM SYSTEMS, INC.

 

  Financial Reporting Package

Form 10-K

 

for the Year Ended

December 31, 2017

   

 

 

 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

 

To the Board of Directors and Stockholders of:

OmniComm Systems, Inc.

 

Opinion on the Financial Statements

 

We have audited the accompanying consolidated balance sheets of OmniComm Systems, Inc. (the “Company”) as of December 31, 2017 and 2016, and the related consolidated statements of operations, comprehensive income/(loss), shareholders ’ (deficit), and cash flows for the years then ended, and the related consolidated notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2017 and 2016, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.

 

Basis for Opinion

 

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 are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting 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.

 

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

 

/s/ Liggett & Webb, P.A.

 

We have served as the Company's auditor since 2010.

 

New York, New York

April 2, 2018

 

 

 

OMNICOMM SYSTEMS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

 

   

December 31, 2017

   

December 31, 2016

 
                 

ASSETS

 
                 

CURRENT ASSETS

               

Cash

  $ 1,176,551     $ 1,439,332  

Accounts receivable, net of allowance for doubtful accounts of $149,980 and $179,813, respectively

    7,492,597       5,455,210  

Prepaid expenses

    297,131       195,915  

Prepaid stock compensation, current portion

    -0-       148,422  

Other current assets

    11,463       35,055  

Total current assets

    8,977,742       7,273,934  

Property and equipment, net

    552,538       637,552  

Other assets

               

Intangible assets, net

    97,925       108,880  

Prepaid stock compensation

    -0-       58,663  

Other assets

    46,714       51,321  
                 

TOTAL ASSETS

  $ 9,674,919     $ 8,130,350  
                 

LIABILITIES AND SHAREHOLDERS' (DEFICIT)

 
                 

CURRENT LIABILITIES

               

Accounts payable and accrued expenses

  $ 2,586,045     $ 2,123,073  

Deferred revenue, current portion

    7,564,587       7,250,061  

Convertible notes payable, current portion

    50,000       50,000  

Patent settlement liability, current portion

    112,500       862,500  

Conversion feature liability, related parties

    1,604,723       1,740,278  

Conversion feature liability

    81,224       585,452  

Warrant liability, related parties

    2,196,570       2,519,614  

Warrant liability

    1,244,229       1,479,748  

Total current liabilities

    15,439,878       16,610,726  
                 

LONG TERM LIABILITIES

               

Line of credit, long term

    2,650,000       2,700,000  

Notes payable, related parties, long term, net of current portion, net of discount of $117,365 and $237,664, respectively

    282,635       212,336  

Notes payable, long term, net of current portion, net of discount of $279,402 and $455,285, respectively

    423,098       337,215  

Deferred revenue, long term, net of current portion

    1,952,366       2,289,169  

Convertible notes payable, related parties, long term, net of current portion

    5,770,000       5,825,000  

Convertible notes payable, long term, net of current portion

    350,000       1,175,000  

Patent settlement liability, long term, net of current portion

    -0-       108,702  
                 

TOTAL LIABILITIES

    26,867,977       29,258,148  
                 

COMMITMENTS AND CONTINGENCIES (See Note 10)

               
                 

SHAREHOLDERS' (DEFICIT)

               

Preferred stock, $0.001 par value, 10,000,000 shares authorized, 3,772,500 shares undesignated

               

Series A convertible preferred stock, 5,000,000 shares authorized, -0- and -0- issued and outstanding, respectively at $0.001 par value; liquidation preference $-0- and $-0-, respectively

    -0-       -0-  

Series B convertible preferred stock, 230,000 shares authorized, -0- and -0- issued and outstanding, respectively at $0.001 par value; liquidation preference $-0- and $-0-, respectively

    -0-       -0-  

Series C convertible preferred stock, 747,500 shares authorized, -0- and -0- issued and outstanding, respectively at $0.001 par value; liquidation preference $-0- and $-0-, respectively

    -0-       -0-  

Series D preferred stock, 250,000 shares authorized, 250,000 and 250,000 issued and outstanding, respectively at $0.001 par value

    250       250  

Common stock, 500,000,000 shares authorized, 148,542,805 and 147,786,917 issued and outstanding, respectively, at $0.001 par value

    148,544       147,788  

Additional paid in capital - preferred

    999,750       999,750  

Additional paid in capital - common

    54,379,454       53,425,956  

Accumulated other comprehensive (loss)

    (397,237 )     (410,505 )

Accumulated (deficit)

    (72,323,819 )     (75,291,037 )
                 

TOTAL SHAREHOLDERS' (DEFICIT)

    (17,193,058 )     (21,127,798 )
                 

TOTAL LIABILITIES AND SHAREHOLDERS' (DEFICIT)

  $ 9,674,919     $ 8,130,350  

 

  See accompanying summary of accounting policies and notes to consolidated financial statements

 

 

 

OMNICOMM SYSTEMS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

 

   

For the year ended

 
   

December 31,

 
   

2017

   

2016

 

Revenues

  $ 26,067,933     $ 24,394,010  

Reimbursable revenues

    911,725       1,025,500  

Total revenues

    26,979,658       25,419,510  
                 

Cost of goods sold

    4,394,918       3,913,407  

Reimbursable expenses-cost of goods sold

    885,972       1,461,425  

Total cost of goods sold

    5,280,890       5,374,832  
                 

Gross margin

    21,698,768       20,044,678  
                 

Operating expenses

               

Salaries, benefits and related taxes

    13,200,837       11,383,727  

Rent and occupancy expenses

    1,125,147       1,071,363  

Consulting services

    321,472       185,340  

Legal and professional fees

    533,221       364,859  

Travel

    986,092       774,379  

Telephone and internet

    152,926       164,014  

Selling, general and administrative

    1,356,427       1,462,774  

Bad debt expense

    130,346       132,767  

Depreciation expense

    336,102       302,893  

Amortization expense

    22,048       37,331  

Total operating expenses

    18,164,618       15,879,447  
                 

Operating income/(loss)

    3,534,150       4,165,231  
                 

Other income/(expense)

               

Interest expense, related parties

    (947,688 )     (918,189 )

Interest expense

    (419,432 )     (421,713 )

Interest income

    593       2  

Change in derivative liabilities

    795,779       (2,657,910 )

Transaction gain/(loss)

    5,010       (64,472 )

Income/(loss) before income taxes

    2,968,412       102,949  

Income tax (expense)

    (1,194 )     (1,069 )

Net income/(loss) attributable to common stockholders

  $ 2,967,218     $ 101,880  
                 

Net income/(loss) per share

               

Basic

  $ 0.02     $ 0.00  

Diluted

  $ 0.02     $ 0.00  

Weighted average number of shares outstanding

               

Basic

    147,865,246       145,868,227  

Diluted

    148,177,984       146,162,427  

  

See accompanying summary of accounting policies and notes to consolidated financial statements

 

 

 

OMNICOMM SYSTEMS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME/( LOSS)

 

   

For the year ended

 
   

December 31,

 
   

2017

   

2016

 

Net income/(loss) attributable to common stockholders

  $ 2,967,218     $ 101,880  

Other comprehensive income/(loss)

               

Change in foreign currency translation adjustment

    13,268       (44,150 )
                 

Other comprehensive income/(loss)

    13,268       (44,150 )
                 

Comprehensive income/(loss)

  $ 2,980,486     $ 57,730  

 

See accompanying summary of accounting policies and notes to consolidated financial statements

 

 

 

OMNICOMM SYSTEMS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENT OF SHAREHOLDERS' (DEFICIT)

FOR THE YEARS ENDED DECEMBER 31, 201 7 AND  DECEMBER 31, 2016

 

   

Preferred Stock

   

Common Stock

                         
   

5% Series A Convertible

   

Series D Preferred

   

Additional

                   

Additional

           

Accumulated

   

 

 
   

 

    $ 0.001    

 

    $ 0.001    

paid in

   

 

    $ 0.001    

paid in

   

 

   

other

   

Total

 
   

Number

of shares

   

Par

value

   

Number

of shares

   

Par

value

   

capital

preferred

   

Number

of shares

   

Par

value

   

capital

common

   

Accumulated

(deficit)

   

comprehensive

(loss)

   

shareholders'

(deficit)

 

Balances at December 31, 2015

    3,637,724     $ 3,637       250,000     $ 250     $ 4,230,792       131,703,577     $ 131,704     $ 49,974,415     $ (75,392,917 )   $ (366,355 )   $ (21,418,474 )
                                                                                         

Employee stock option expense

                                                            35,046                       35,046  
                                                                                         

Foreign currency translation adjustment

                                                                            (44,150 )     (44,150 )
                                                                                         

Restricted stock issuance/(forfeiture)

                                            360,000       360       68,040                       68,400  
                                                                                         

Issuance of common stock, stock option exercise

                                            1,100,000       1,100       128,400                       129,500  
                                                                                         

Cashless issuance of common stock, stock option exercise

                                            7,644       8       (8 )                     -0-  
                                                                                         

Issuance of common stock, in exchange for Series A Preferred Stock

    (3,637,724 )     (3,637 )                     (3,231,042 )     14,615,696       14,616       3,220,063                       -0-  
                                                                                         

Net income/(loss) for the year ended December 31, 2016

    -0-       -0-       -0-       -0-       -0-       -0-       -0-       -0-       101,880       -0-       101,880  
                                                                                         

Balances at December 31, 2016

    -0-       -0-       250,000       250       999,750       147,786,917       147,788       53,425,956       (75,291,037 )     (410,505 )     (21,127,798 )
                                                                                         

Employee stock option expense

                                                            364,271                       364,271  
                                                                                         

Foreign currency translation adjustment

                                                                            13,268       13,268  
                                                                                         

Restricted stock issuance/(forfeiture)

                                            (16,668 )     (17 )     (2,817 )                     (2,834 )
                                                                                         

Cashless issuance of common stock, stock option exercise

                                            22,556       23       (23 )                     -0-  
                                                                                         

Issuance of common stock, stock option exercise

                                            250,000       250       35,000                       35,250  
                                                                                         

Issuance of common stock, warrant exercise

                                            500,000       500       154,500                       155,000  
                                                                                         

Reclassifiacation of conversion feature liability associated with convertible debt

                                                            402,567                       402,567  
                                                                                         

Net income/(loss) for the year ended December 31, 2017

    -0-       -0-       -0-       -0-       -0-       -0-       -0-       -0-       2,967,218       -0-       2,967,218  
                                                                                         

Balances at December 31, 2017

    -0-     $ -0-       250,000     $ 250     $ 999,750       148,542,805     $ 148,544     $ 54,379,454     $ (72,323,819 )   $ (397,237 )   $ (17,193,058 )

  

See accompanying summary of accounting policies and notes to consolidated financial statements

 

 

 

OMNICOMM SYSTEMS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

   

For the year ended

 
   

December 31,

 
   

2017

   

2016

 
                 

CASH FLOWS FROM OPERATING ACTIVITIES

               

Net income/(loss)

  $ 2,967,218     $ 101,880  

Adjustment to reconcile net income/(loss) to net cash provided by/(used in) operating activities

               

Change in derivative liabilities

    (795,779 )     2,657,910  

Interest expense from derivative instruments

    296,182       158,068  

Employee stock compensation

    568,522       222,304  

Provision for doubtful accounts

    130,346       132,767  

Depreciation and amortization

    358,150       340,224  

Changes in operating assets and liabilities

               

Accounts receivable

    (2,167,733 )     (1,495,505 )

Prepaid expenses

    (101,216 )     (25,742 )

Other current assets

    23,592       (20,704 )

Other assets

    4,607       (4,756 )

Accounts payable and accrued expenses

    462,972       615,803  

Patent settlement liability

    (858,702 )     (455,871 )

Deferred revenue

    (22,277 )     291,453  

Net cash provided by/(used in) operating activities

    865,882       2,517,831  
                 

CASH FLOWS FROM INVESTING ACTIVITIES

               

Purchase of property and equipment

    (242,384 )     (260,378 )

Net cash (used in) investing activities

    (242,384 )     (260,378 )
                 

CASH FLOWS FROM FINANCING ACTIVITIES

               

Repayments of notes payable

    (915,000 )     (200,000 )

Repayments of notes payable, related parties

    (105,000 )     (45,000 )

Proceeds/(repayments) from revolving line of credit

    (50,000 )     (1,500,000 )

Proceeds from exercise of stock options

    35,250       129,500  

Proceeds from exercise of warrants

    155,000       -0-  

Net cash provided by/(used in) financing activities

    (879,750 )     (1,615,500 )
                 

Effect of exchange rate changes on fixed and intangible assets 

 

    (19,797 )     6,310  

Effect of exchange rate changes on cash and cash equivalents

    13,268       (44,150 )

Net increase/(decrease) in cash and cash equivalents

    (262,781 )     604,113  

Cash and cash equivalents at beginning of period

    1,439,332       835,219  
                 

Cash and cash equivalents at end of period

  $ 1,176,551     $ 1,439,332  
                 

Supplemental disclosures of cash flow information:

               

Cash paid during the period for:

               

Income taxes

  $ 1,194     $ 1,069  

Interest

  $ 1,051,909     $ 1,445,684  
                 

Non-cash transactions:

               

Notes payable issued in exchange for existing notes payable

  $ 350,000     $ 7,652,500  

Restricted stock issuance/(forfeiture)

  $ (2,834 )   $ 68,400  

Promissory notes issued for accrued interest

  $ -0-     $ 450,000  

Common stock issued in exchange for 5% Series A Preferred Stock

  $ -0-     $ 3,637,724  

Reclassification of conversion feature liability associated with convertible debt

  $ 402,567     $ -0-  

  

See accompanying summary of accounting policies and notes to consolidated financial statements

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

 

NOTE 1:                 ORGANIZATION AND NATURE OF OPERATIONS

 

OmniComm Systems, Inc. (“OmniComm” or the “Company”) is a healthcare te chnology company that provides web-based electronic data capture (“EDC”) solutions and related value-added services to pharmaceutical and biotechnology companies, contract research organizations (“CROs”), and other clinical trial sponsors principally located in the United States, Europe and East Asia. Our proprietary EDC software applications; TrialMaster ® ; TrialOne ® ; IRTMaster ; Promasys ® ; and eClinical Suite , allow clinical trial sponsors and investigative sites to securely collect, validate, transmit, and analyze clinical trial data.

 

Our ability to compete within the EDC industry is predicated on our ability to continue enhancing and broadening the scope of solutions offered through our EDC software and services.   Our research and product development efforts are focused on developing new and complementary software solutions, as well as enhancing our existing software solutions through the addition of increased functionality.  During the year ended December 31, 2017 we spent approximately $2,854,428  and during the year ended  December 31, 2016 we spent approximately $2 ,598,962  on research and product development activities, which is primarily comprised of salaries to our developers and other research and product development personnel and related costs associated with the development of our software products

 

 

NOTE 2:                  SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

BASIS OF PRESENTATION AND PRINCIPLES OF CONSOLIDATION

 

The Company ’s accounts include those of all its wholly-owned subsidiaries and have been prepared in conformity with (i) accounting principles generally accepted in the United States of America; and (ii) the rules and regulations of the United States Securities and Exchange Commission.  All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated in consolidation.

 

ESTIMATES IN FINANCIAL STATEMENTS

 

The preparation of the consolidated financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and footnotes thereto.   Significant estimates incorporated in our financial statements include the recorded allowance for doubtful accounts, the estimate of the appropriate amortization period of our intangible assets, the evaluation of whether our intangible assets have suffered any impairment, the allocation of revenues under multiple-element customer contracts, royalty-based patent liabilities, the value of derivatives associated with debt and warrants issued by the Company and the valuation of any corresponding discount to the issuance of our debt.  Actual results may differ from those estimates.

 

RECLASSIFICATIONS

 

Certain reclassifications have been made in the 2016 financial statements to conform to the 2017 presentation.  These reclassifications did not have any effect on our net income/(loss) or shareholders’ (deficit).

 

FOREIGN CURRENCY TRANSLATION

 

The financial statements of the Company ’s foreign subsidiaries are translated in accordance with ASC 830 - 30, Foreign Currency Matters—Translation of Financial Statements . The reporting currency for the Company is the U.S. dollar. The functional currency of the Company’s subsidiaries, OmniComm Europe GmbH in Germany, OmniComm Spain S.L. in Spain and OmniComm Systems B.V. in the Netherlands is the Euro. The functional currency of the Company's subsidiary, OmniComm Ltd. in the United Kingdom is the British Pound Sterling. Accordingly, the assets and liabilities of the Company’s foreign subsidiaries are translated into U.S. dollars using the exchange rate in effect at each balance sheet date. Revenue and expense accounts of the Company’s foreign subsidiaries are translated using an average rate of exchange during the period. Foreign currency translation adjustments are accumulated as a component of other comprehensive income/(loss) as a separate component of stockholders’ equity. Gains and losses arising from transactions denominated in foreign currencies are primarily related to intercompany accounts that have been determined to be temporary in nature and accordingly, are recorded directly to the statement of operations.  We record translation gains and losses in accumulated other comprehensive income as a component of stockholders’ equity. We recorded a translation gain of $13,268 for the year ended December 31, 2017 and a translation loss of $44,150 for the year ended December 31, 2016.

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

REVENUE RECOGNITION POLICY

 

The Company derives revenues from software licenses and services of its EDC products and services which can be purchased on a stand-alone basis. License revenues are derived principally from the sale of term licenses for the following software products offered by the Company: TrialMaster, TrialOne , IRTMaster, Promasys and eClinical Suite ( the “EDC Software”). Service revenues are derived principally from the Company's delivery of the hosted solutions of its TrialMaster and eClinical Suite software products, and consulting services and customer support, including training, for all of the Company's products.

 

The Company recognizes revenues when all of the following conditions are satisfied: ( 1 )  there is persuasive evidence of an arrangement; ( 2 ) the product or service has been provided to the customer; ( 3 ) the collection of fees is probable; and ( 4 ) the amount of fees to be paid by the customer is fixed or determinable.

 

The Company operates in one reportable segment which is the delivery of EDC software and services to clinical trial sponsors.   The Company segregates its revenues based on the activity cycle used to generate its revenues.  Accordingly, revenues are currently generated through four main activities. These activities include hosted applications, licensing, professional services and maintenance-related services.

 

Hosted Application Revenues

 

The Company offers its TrialMaster and eClinical Suite software products as hosted application solutions delivered through a standard web-browser, with customer support and training services.

 

Revenues resulting from TrialMaster and eClinical Suite application hosting services consist of three components of services for each clinical trial: the first component is comprised of application set up, including design of electronic case report forms and edit checks, installation and server configuration of the system.  The second component involves application hosting and related support services as well as billable change orders which consist of amounts billed to customers for functionality changes made. The third stage involves services required to close out, or lock, the database for the clinical trial.

 

Fees charged for the trial system design, set up and implementation are amortized and recognized ratably over the estimated hosting period.   Work performed outside the original scope of work is contracted for separately as an additional fee and is generally recognized ratably over the remaining term of the hosting period. Fees for the first and third stages of the service are billed based upon milestones.  Revenues earned upon completion of a contractual milestone are deferred and recognized over the estimated remaining hosting period.   Fees for application hosting and related services in the second stage are generally billed quarterly in advance.  Revenues resulting from hosting services for the eClinical Suite products consist of installation and server configuration, application hosting and related support services. Services for this offering are generally charged as a fixed fee payable on a quarterly or annual basis. Revenues are recognized ratably over the period of the service.

 

Licensing Revenues

 

The Company's software license revenues are earned from the sale of off-the-shelf software.   From time-to-time a client might require significant modification or customization subsequent to delivery to the customer.  The Company generally enters into software term licenses for its EDC software products with its customers for 3 to 5  year periods, although customers have entered into both longer and shorter term license agreements.  These arrangements typically include multiple elements: software license, consulting services and customer support. The Company bills its customers in accordance with the terms of the underlying contract. Generally, the Company bills license fees in advance for each billing cycle of the license term which typically is either on a quarterly or annual basis. Payment terms are generally net 30 or net 45  days.

 

In the past the Company has sold perpetual licenses for EDC Software products in certain situations to existing customers with the option to purchase customer support, and may in the future do so for new customers based on customer requirements or market conditions. The Company has established vendor specific objective evidence of fair value for the customer support. Accordingly, license revenues are recognized upon delivery of the software and when all other revenue recognition criteria are met. Customer support revenues are recognized ratably over the term of the underlying support arrangement.   The Company generates customer support and maintenance revenues from its perpetual license customer base.

 

Professional Services

 

The Company may also enter into arrangements to provide consulting services separate from a license arrangement. In these situations, revenue is recognized on a time-and-materials basis. Professional services can be deemed to be as essential to the functionality of the software at inception and typically are for initial trial configuration, implementation planning, loading of software, building simple interfaces and running test data and documentation of procedures.   Subsequent additions or extensions to license terms do not generally include additional professional services.

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

Maintenance Revenues

 

Maintenance includes telephone-based help desk support and software maintenance. The Company generally bundles customer support with the software license for the entire term of the arrangement. As a result, the Company generally recognizes revenues for both maintenance and software licenses ratably over the term of the software license and support arrangement. The Company allocates the revenues recognized for these arrangements to the different elements based on management's estimate of the relative fair value of each element.   The Company generally invoices each of the elements based on separately quoted amounts and thus has a fairly accurate estimate of the relative fair values of each of the invoiced revenue elements.

 

The fees associated with each business activity for the years ended December 31, 2017 and December 31, 2016, respectively are:

 

   

For the year ended

 

Revenue activity

 

December 31, 2017

   

December 31, 2016

 

Set-up fees

  $ 4,981,941     $ 6,658,987  

Change orders

    1,540,167       1,212,153  

Maintenance

    5,107,787       4,803,171  

Software licenses

    10,658,977       7,885,023  

Professional services

    3,359,554       3,843,641  

Hosting

    1,331,232       1,016,535  

Total

  $ 26,979,658     $ 25,419,510  

 

 

COST OF GOOD S SOLD

 

Cost of goods sold primarily consists of costs related to hosting, maintaining and supporting the Company’s application suite and delivering professional services and support. These costs include salaries, benefits, bonuses and stock-based compensation for the Company’s professional services staff. Cost of goods sold also includes outside service provider costs .   Cost of goods sold is expensed as incurred.

 

CASH AND CASH EQUIVALENTS

 

Cash equivalents consist of highly liquid, short-term investments with maturities of 90 days or less.   The carrying amount reported in the accompanying consolidated balance sheets approximates fair value.

 

ACCOUNTS RECEIVABLE

 

Accounts receivable are judged as to collectability by management and an allowance for bad debts is established as necessary. The allowance is based on an evaluation of the collectability of accounts receivable and prior bad debt experience.   The Company had recorded an allowance for uncollectible accounts receivable of $149,980 as of December 31, 2017 and $179,813 as of December 31, 2016.

 

The following table summarizes activity in the Company's allowance for doubtful accounts for the years presented.

 

   

December 31, 2017

   

December 31, 2016

 

Beginning of period

  $ 179,813     $ 116,834  

Bad debt expense

    130,346       132,767  

Write-offs

    (160,179 )     (69,788 )

End of period

  $ 149,980     $ 179,813  

 

 

CONCENTRATION OF CREDIT RISK

 

Cash and cash equivalents and restricted cash are deposited with major financial institutions and, at times, such balances with any one financial institution may be in excess of FDIC-insured limits. As of December 31, 2017, $755,893 was deposited in excess of FDIC-insured limits.  Management believes the risk in these situations to be minimal.

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

Except as follows, the Company has no significant off balance sheet risk or credit risk concentrations. Financial instruments that subject the Company to potential credit risks are principally cash equivalents and accounts receivable. Concentrated credit risk with respect to accounts receivable is limited to creditworthy customers. The Company's customers are principally located in the United States, Europe and East Asia.   The Company is directly affected by the overall financial condition of the pharmaceutical, biotechnology and medical device industries and management believes that credit risk exists and that any credit risk the Company faces has been adequately reserved for as of December 31, 2017.   The Company maintains an allowance for doubtful accounts based on accounts past due according to contractual terms and historical collection experience. Actual losses when incurred are charged to the allowance. The Company's losses related to collection of accounts receivable have consistently been within management's expectations.  As of December 31, 2017, the Company believes no additional credit risk exists beyond the amounts provided for in our allowance for uncollectible accounts.  The Company evaluates its allowance for uncollectable accounts on a monthly basis based on a specific review of receivable aging and the period that any receivables are beyond the standard payment terms. The Company does not require collateral from its customers in order to mitigate credit risk.

 

One customer accounted for 10% of our revenue during the year ended December 31, 2017 or approximately $2,691,000. One customer accounted for 16% of our revenues during the year ended December 31, 2016 or approximately $4,167,000.   The following table summarizes the number of customers who individually comprise 10% or more of total revenue and/or total accounts receivable and their aggregate percentage of the Company's total revenue and gross accounts receivable for the years presented.

 

One customer accounted for approximately 24% of our accounts receivable  as of December 31, 2017. Two customers each individually accounted for approximately 11% of our accounts receivables as of December 31, 2016. 

 

 

   

Revenues

   

Accounts receivable

 

For the period ended

 

Number of

customers

   

Percentage of

total revenues

   

Number of

customers

   

Percentage of

accounts receivable

 

December 31, 2017

    1       10%       1       24%  

December 31, 2016

    1       16%       2       21%  

 

 

The table below provides revenues from European customers for the years ended December 31, 2017 and December 31, 2016.

 

European revenues

 

For the year ended

 

December 31, 2017

   

December 31, 2016

 

European revenues

   

% of Total revenues

   

European revenues

   

% of Total revenues

 
  $3,632,537       14%       $2,702,660       11%  

 

The Company serves all of its hosting customers from third -party web hosting facilities located in the United States. The Company does not control the operation of these facilities, and they are vulnerable to damage or interruption. The Company maintains redundant systems that can be used to provide service in the event the third -party web hosting facilities become unavailable, although in such circumstances, the Company's service may be interrupted during the transition.

 

PROPERTY AND EQUIPMENT

 

Property and equipment are recorded at cost.   Additions and betterments are capitalized; maintenance and repairs are expensed as incurred.  Depreciation is calculated using the straight-line method over the asset’s estimated useful life, which is 5 years for leasehold improvements, computers, equipment and furniture and 3 years for software.  Gains or losses on disposal are charged to operations.

 

ASSET IMPAIRMENT

 

Acquisitions and Intangible Assets

 

We account for acquisitions in accordance with ASC 805, Business Combinations (“ASC 805” ) and ASC 350, Intangibles- Goodwill and Other (“ASC 350” ). The acquisition method of accounting requires that assets acquired and liabilities assumed be recorded at their fair values on the date of a business acquisition. Our consolidated financial statements and results of operations reflect an acquired business from the completion date of an acquisition.

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

The judgments that we make in determining the estimated fair value assigned to each class of assets acquired and liabilities assumed, as well as asset lives, can materially impact net income in periods following an asset acquisition. We generally use either the income, cost or market approach to aid in our conclusions of such fair values and asset lives. The income approach presumes that the value of an asset can be estimated by the net economic benefit to be received over the life of the asset, discounted to present value. The cost approach presumes that an investor would pay no more for an asset than its replacement or reproduction cost. The market approach estimates value based on what other participants in the market have paid for reasonably similar assets. Although each valuation approach is considered in valuing the assets acquired, the approach ultimately selected is based on the characteristics of the asset and the availability of information.

 

Long-lived Assets

 

We review long-lived assets for impairment whenever events or changes in circumstances indicate that the related carrying amounts may not be recoverable. Determining whether an impairment has occurred typically requires various estimates and assumptions, including determining which cash flows are directly related to the potentially impaired asset, the useful life over which cash flows will occur, their amount and the asset ’s residual value, if any. In turn, measurement of an impairment loss requires a determination of fair value, which is based on the best information available. We use quoted market prices when available and independent appraisals and management estimates of future operating cash flows, as appropriate, to determine fair value.

 

DEFERRED REVENUE

 

Deferred revenue represents cash advances received in excess of revenue earned on on-going contracts.   Payment terms vary with each contract but may include an initial payment at the time the contract is executed, with future payments dependent upon the completion of certain contract phases or targeted milestones.  In the event of contract cancellation, the Company is generally entitled to payment for all work performed through the point of cancellation.  As of December 31, 2017, the Company had $9,516,953 in deferred revenues relating to contracts for services to be performed over periods ranging from 1 month to 5 years.  The Company had $7,564,587 in deferred revenues that are expected to be recognized in the next twelve fiscal months.

 

ADVERTISING

 

Advertising costs are expensed as incurred.   Advertising costs were $701,161 for the year ended December 31, 2017 and $712,179 for the year ended December 31, 2016 and are included under selling, general and administrative expenses on our consolidated financial statements.

 

RESEARCH AND PRODUCT DEVELOPMENT EXPENSES

 

Software development costs are included in research and product development and are expensed as incurred.   ASC 985.20, Software Industry Costs of Software to Be Sold, Leased or Marketed , requires the capitalization of certain development costs of software to be sold once technological feasibility is established, which the Company defines as completion to the point of marketability.  The capitalized cost is then amortized on a straight-line basis over the estimated product life.  To date, the period between achieving technological feasibility and the general availability of such software has been short and software development costs qualifying for capitalization have been immaterial.  Accordingly, the Company has not capitalized any software development costs under ASC 985.20.   During the year ended December 31, 2017 we spent approximately $2,854,428 and during the year ended December 31, 2016 we spent approximately $2,598,962, on research and product development activities, which include costs associated with the development of our software products and services for our client’s projects and which are primarily comprised of salaries and related expenses for our software developers and consulting fees paid to third -party consultants.  Research and product development costs are primarily included under Salaries, benefits and related taxes in our Statement of Operations.

 

EMPLOYEE EQUITY INCENTIVE PLANS

 

The OmniComm Systems, Inc. 2016 Equity Incentive Plan (the “2016 Plan”) was approved at our Annual Meeting of Stockholders on June 16, 2016. The 2016 Plan provides for the issuance of up to 10,000,000 shares of our common stock. In addition, the number of shares of common stock available for issuance under the 2016 Plan shall automatically increase on January 1st of each year for a period of nine ( 9 ) years commencing on January 1, 2017 and ending on (and including) January 1, 2025, in an amount equal to five percent ( 5% ) of the total number of shares authorized under the 2016 Plan. As of December 31, 2017 10,500,000 shares were authorized under the 2016 Plan.

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

The predecessor plan, the OmniComm Systems, Inc. 2009 Equity Incentive Plan (the “2009 Plan”) was approved at our Annual Meeting of Stockholders on July 10, 2009 and terminated on June 16, 2016 upon the approval of the 2016 Plan.  The 2009 Plan provided for the issuance of up to 7.5 million shares to employees, directors and key consultants in accordance with the terms of the 2009 Plan documents.  

 

Each plan is more fully described in “Note 1 3, Employee Equity Incentive Plans.”  The Company accounts for its employee equity incentive plans under ASC 718, Compensation – Stock Compensation which addresses the accounting for transactions in which an entity exchanges its equity instruments for goods or services, with a primary focus on transactions in which an entity obtains employee services in share-based payment transactions.

 

ASC 718 requires companies to estimate the fair value of share-based payment awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods in the Company ’s consolidated statements of operations. The Company currently uses the Black Scholes option pricing model to determine grant date fair value.

 

EARNINGS/(LOSS)  PER SHARE

 

The Company accounts for Earnings/(loss) Per Share using ASC 260 – Earnings per Share.  Unlike diluted earnings per share, basic earnings per share excludes any dilutive effects of options, warrants, and convertible securities.

 

INCOME TAXES

 

The Company accounts for income taxes in accordance with ASC 740, Income Taxes.   ASC 740 has as its basic objective the recognition of current and deferred income tax assets and liabilities based upon all events that have been recognized in the financial statements as measured by the provisions of the enacted tax laws

 

Valuation allowances are established , when necessary, to reduce deferred tax assets to the estimated amount to be realized.  Income tax expense represents the tax payable for the current period and the change during the period in the deferred tax assets and liabilities.

 

On December 22, 2017, the Tax Cuts and Jobs Act ("Tax Act") was signed into law by the President of the United States. The Tax Act is a tax reform act that among other things, reduced corporate tax rates to 21 percent effective January 1, 2018. FASB ASC 740, Income Taxes , requires deferred tax assets and liabilities to be adjusted for the effect of a change in tax laws or rates in the year of enactment, which is the year in which the change was signed into law. Accordingly, the Company adjusted its deferred tax assets and liabilities at December 31, 2017, using the new corporate tax rate of 2l percent. See Note 14. Income Taxes.

 

IMPACT OF NEW ACCOUNTING STANDARDS

 

During fiscal 2017, we adopted the following new accounting pronouncements:

 

In February 2016, the FASB issued accounting standard update (“ ASU”) No. 2016 - 02, “Leases (Topic 842 )” , (“ASU 2016 - 02” ). This ASU requires that an entity should recognize assets and liabilities for leases with a maximum possible term of more than 12 months. A lessee would recognize a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the leased asset (the underlying asset) for the lease term. This guidance also provides accounting updates with respect to lessor accounting under a lease arrangement. This new lease guidance is effective for fiscal years beginning after December 15, 2019. Entities have the option of using either a full retrospective or a modified approach (cumulative effect adjustment in period of adoption) to adopt the new guidance. Early adoption is permitted for all entities. We are currently evaluating the impact of the adoption of this guidance in our consolidated financial statements.

 

In March 2016, April 2016, and December 2016, the FASB issued ASU 2016 - 08, " Revenue from Contracts with Customers - Principal versus Agent Considerations (Reporting Revenue Gross versus Net) ", (“ASU 2016 - 08” ), ASU 2016 - 10, " Revenue from Contracts with Customers - Identifying Performance Obligations and Licensing ", (“ASU 2016 - 10” ), and ASU  2016 - 20,  " Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers" , (“ASU 2016 - 20” ) respectively, which further clarify the guidance for those specific topics within ASU 2014 - 09. In May 2016, the FASB issued ASU 2016 - 12, " Revenue from Contracts with Customers - Narrow Scope Improvements and Practical Expedients ", to reduce the risk of diversity in practice for certain aspects in ASU 2014 - 09, including collectability, noncash consideration, presentation of sales tax and transition. These updates permit the use of either the retrospective or cumulative effect transition method. Early application is permitted as of the original effective date for annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. 

 

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

In July 2017, The Financial Accounting Standards Board issued Accounting Standards Update 2017 - 11 Earnings per Share (Topic 260 ), Distinguishing Liabilities from Equity (Topic 480 ), Derivatives and Hedging (Topic 815 ) ” (“ASU 2017 - 11” ) This ASU addresses narrow issues identified as a result of the complexity associated with applying generally accepted accounting principles (GAAP) for certain financial instruments with characteristics of liabilities and equity. Part I of the amendment change the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features. The amendments also clarify existing disclosure requirements for equity-classified instruments. Part II of the update recharacterize the indefinite deferral of certain provisions of Topic 480 that now are presented as pending content in the Codification, to a scope exception. Those amendments do not have an accounting effect. Part I of ASU 2017 - 11 is effective for public business entities for fiscal years, and interim period within those fiscal years, beginning after December 15, 2018, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU- 2017 - 11.

 

Accounting standards-setting organizations frequently issue new or revised accounting rules. We regularly  review all new pronouncements to determine their impact, if any, on our financial statements.

 

 

NOTE 3:                    EARNINGS/(LOSS) PER SHARE

 

Basic income/(loss) per share was calculated using the weighted average number of shares outstanding of 147,865,246 for the year ended December 31, 2017 and 145,868,227 for the year ended December 31, 2016.

 

Antidilutive shares aggregating 43,343,224 for the year ended December 31, 2017 and 43,775,016 for the year ended December 31, 2016 have been omitted from the calculation of dilutive income/(loss) per share as the shares were antidilutive. The table below provides a reconciliation of anti-dilutive securities outstanding as of December 31, 2017 and December 31, 2016.

 

Anti-dilutive security

 

December 31, 2017

   

December 31, 2016

 

Employee stock options

    4,225,000       275,000  

Warrants

    27,020,000       27,860,000  

Convertible notes

    11,980,000       15,490,000  

Shares issuable for accrued interest

    118,224       150,016  

Total

    43,343,224       43,775,016  

 

The employee stock options are exercisable at prices ranging from $0. 17 to $0.34 per share.  The exercise price on the stock warrants range from $0.25 to $0.60 per share.  Shares issuable upon conversion of Convertible Debentures have conversion prices ranging from $0.25 to $1.25  per share.

 

Provided below is the reconciliation between numerators and denominators of the basic and diluted income/(loss) per shares.  

 

   

For the year ended

 
   

December 31, 2017

   

December 31, 2016

 
   

Income/(loss)

   

Shares

   

Per-share

   

Income/(loss)

   

Shares

   

Per-share

 
   

numerator

   

denominator

   

amount

   

numerator

   

denominator

   

amount

 

Basic EPS

  $ 2,967,218       147,865,246     $ 0.02     $ 101,880       145,868,227     $ 0.00  
                                                 

Effect of dilutive securities

    4,766       312,738       -0-       -0-       294,200       -0-  
                                                 

Diluted EPS

  $ 2,971,984       148,177,984     $ 0.02     $ 101,880       146,162,427     $ 0.00  

 

 

NOTE 4 :                 PROPERTY AND EQUIPMENT, NET

 

Property and equipment consists of the following:

 

   

December 31, 2017

   

December 31, 2016

         
   

Cost

   

Accumulated depreciation

   

Net book

value

   

Cost

   

Accumulated depreciation

   

Net book

value

   

Estimated

useful life

(years)

 

Computer & office equipment

  $ 2,322,833     $ 1,949,982     $ 372,851     $ 2,125,067     $ 1,761,879     $ 363,188       5  

Leasehold improvements

    118,380       98,901       19,479       114,719       89,789       24,930       5  

Computer software

    2,010,999       1,886,342       124,657       1,925,462       1,720,399       205,063       3  

Office furniture

    162,799       127,248       35,551       158,436       114,065       44,371       5  

Total

  $ 4,615,011     $ 4,062,473     $ 552,538     $ 4,323,684     $ 3,686,132     $ 637,552          

 

Depreciation expense was $336,102 for the year ended December 31, 2017 and $302,893 for the year ended December 31, 2016.

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

 

NOTE 5 :                 INTANGIBLE ASSETS, NET

 

Intangible assets consist of the following:

 

   

December 31, 2017

   

December 31, 2016

         

Asset

 

Cost

   

Accumulated amortization

   

Net book

value

   

Cost

   

Accumulated amortization

   

Net book

value

   

Estimated

useful life

(years)

 

eClinical Suite customer lists

  $ 1,392,701     $ 1,392,701     $ -0-     $ 1,392,701     $ 1,392,701     $ -0-       3  

Promasys B.V. customer lists

    118,780       32,994       85,786       104,163       21,990       82,173       15  

Promasys B.V. software code

    72,837       60,698       12,139       72,837       46,130       26,707       5  

Promasys B.V. URLs/website

    59,990       59,990       -0-       52,608       52,608       -0-       3  

Total

  $ 1,644,308     $ 1,546,383     $ 97,925     $ 1,622,309     $ 1,513,429     $ 108,880          

 

 

Amortization expense was $ 22,048 for the year ended December 31, 2017 and $37,331 for the year ended December 31, 2016.  

 

Annual amortization expense for the Company ’s intangible assets is as follows:

 

Year

 

Amortization

 

2018

  $ 20,058  

2019

    7,919  

2020

    7,919  

2021

    7,919  

2022

    7,919  

Thereafter

    46,191  

Total

  $ 97,925  

 

 

NOTE 6 :                 ACCOUNTS PAYABLE AND ACCRUED EXPENSES

 

Accounts payable and accrued expenses consist of the following:

 

Account

 

December 31, 2017

   

December 31, 2016

 

Accounts payable

  $ 1,303,073     $ 697,060  

Accrued payroll and related costs

    925,890       886,334  

Other accrued expenses

    184,131       431,961  

Accrued interest

    172,951       107,718  

Total accounts payable and accrued expenses

  $ 2,586,045     $ 2,123,073  

 

 

NOTE 7:                  LINE OF CREDIT, NOTES PAYABLE AND LIQUIDITY

 

On March 18, 2013, the Company entered into a $2,000,000 revolving Line of Credit with The Northern Trust Company ("Line of Credit") guaranteed by Cornelis F. Wit, our then Chief Executive Officer and Director ("Mr. Wit"). Mr. Wit receives 2.0% interest (approximately $9,500 per month) on the assets pledged for the Line of Credit. On December 18, 2013 the Company renewed the Line of Credit and increased the available balance to $4,000,000. On February 3, 2015 the Company renewed the Line of Credit and increased the available balance to $5,000,000. On April 7, 2017 the Company renewed the Line of Credit.  The Line of Credit matures on April 7 , 2020  and carries a variable interest rate based on the prime rate. At December 31, 2017, $2,650,000 was outstanding on the Line of Credit at an interest rate of 3.5%.

 

Our primary sources of working capital are funds from operations and borrowings under our Line of Credit. In the event that the Line of Credit is called for any reason, Mr. Wit has pledged to replace the borrowing capacity under the Line of Credit with a promissory note that utilizes the same maturity date and interest rate as the Line of Credit.

 

To satisfy our capital requirements, we may seek additional financing. There can be no assurance that any such funding will be available to us on favorable terms or at all. If adequate funds are not available when needed, we may be required to delay, scale back or eliminate some or all of our research and product development and marketing programs. If we are successful in obtaining additional financings, the terms of such financings may have the effect of diluting or adversely affecting the holdings or the rights of the holders of our common and preferred stock or result in increased interest expense in future periods.

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

At December 31, 2017, the Company owed $1,102,500 in notes payable all of which are unsecured.  The table below provides details as to the terms and conditions of the notes payable.

 

               

Ending

   

Non related party

   

Related party

 

Origination

 

Maturity

 

Interest

   

principal

           

Long

           

Long

 

date

 

date

 

rate

   

December 31, 2017

   

Current

   

term

   

Current

   

term

 

2/29/2016

 

4/1/2019

    12%     $ 400,000     $ -0-     $ -0-     $ -0-     $ 400,000  

6/30/2016

 

4/1/2020

    10%       420,000       -0-       420,000       -0-       -0-  

6/30/2016

 

4/1/2020

    12%       282,500       -0-       282,500       -0-       -0-  

Discount on notes payable

                    -0-       (279,402 )     -0-       (117,365 )

Total

          $ 1,102,500     $ -0-     $ 423,098     $ -0-     $ 282,635  

 

At December 31, 2016, the Company owed $1,242,500 in notes payable all of which are unsecured.  The table below provides details as to the terms and conditions of the notes payable.

 

               

Ending

   

Non related party

   

Related party

 

Origination

 

Maturity

 

Interest

   

principal

           

Long

           

Long

 

date

 

date

 

rate

   

December 31, 2016

   

Current

   

term

   

Current

   

term

 

2/29/2016

 

4/1/2019

    12%     $ 450,000     $ -0-     $ -0-     $ -0-     $ 450,000  

6/30/2016

 

4/1/2020

    10%       420,000       -0-       420,000       -0-       -0-  

6/30/2016

 

4/1/2020

    12%       372,500       -0-       372,500       -0-       -0-  

Discount on notes payable

                    -0-       (455,285 )     -0-       (237,664 )

Total

          $ 1,242,500     $ -0-     $ 337,215     $ -0-     $ 212,336  

 

On April 1, 2015 the Company issued a promissory note in the amount of $20,000 to our then Chairman and Chief Technology Officer, Randall G. Smith (“Mr. Smith”) in exchange for an existing promissory note in the same amount.  The promissory note carries an interest rate of 12% and has a maturity date of April 1, 2018. O n December 14, 2016 t he $20,000 note was repaid in full .

 

On February 29, 2016, the Company issued a promissory note in the principal amount of $450,000 and warrants to purchase 1,800,000 shares of common stock of the Company at an exercise price of $0.25 per share with an expiration date of April 1, 2019 to our then Chief Executive Officer and Director, Cornelis F. Wit (“Mr. Wit”), in exchange for accrued interest in the amount of $450,000. The note carries an interest rate of 12% per annum and has a maturity date of April 1, 2019. On December 5, 2016 Mr. Wit sold 1,000,000 of the warrants to an employee of the Company. On August 31, 2017 the Company repaid $50,000  of the outstanding principal to Mr. Wit.

 

This issuance caused us to calculate and record a derivative liability for the warrant liability. The warrants were valued using the Black Scholes option pricing model. A value of $325,689 was calculated and allocated to the warrants and recorded as a liability to the issuance of the note payable. As a result of the liability we recorded a discount to the note payable. The carrying amount of the note at the time of issuance was therefore $124,311. The warrant liability (discount) will be amortized over the 37 month duration of the note payable. The Company will continue to perform a fair value calculation quarterly on the warrant liability and accordingly the warrant liability is increased or decreased based on the fair value calculation. The resulting increase or decrease is reflected in the statement of operations as an unrealized gain or loss on changes in derivative liabilities.

 

On June 30, 2016, the Company issued promissory notes in the principal amount of $372,500 and warrants to purchase 1,490,000 shares of common stock of the Company at an exercise price of $0.25 per share with an expiration date of April 1, 2020 to two investors, in exchange for existing promissory notes in the same amount. The notes carry an interest rate of 12% per annum and have a maturity date of April 1, 2020. On August 31 , 2017  a promissory note for $90,000 was repaid in full.

 

This issuance caused us to calculate and record a derivative liability for the warrant liability. The warrants were valued using the Black Scholes option pricing model. A value of $246,921 was calculated and allocated to the warrants and recorded as a liability to the issuance of the notes payable. As a result of the liability we recorded a discount to the notes payable. The carrying amount of the notes at the time of issuance was therefore $125,579. The warrant liability (discount) will be amortized over the 45 month duration of the notes payable. The Company will continue to perform a fair value calculation quarterly on the warrant liability and accordingly the warrant liability is increased or decreased based on the fair value calculation. The resulting increase or decrease is reflected in the statement of operations as an unrealized gain or loss on changes in derivative liabilities.

 

On June 30, 2016, the Company issued promissory notes in the principal amount of $420,000 and warrants to purchase 1,680,000 shares of common stock of the Company at an exercise price of $0.25 per share with an expiration date of April 1, 2020 to two investors, in exchange for existing promissory notes in the same amount. The notes carry an interest rate of 10% per annum and have a maturity date of April 1, 2020.

 

This issuance caused us to calculate and record a derivative liability for the warrant liability. The warrants were valued using the Black Scholes option pricing model. A value of $278,408 was calculated and allocated to the warrants and recorded as a liability to the issuance of the notes payable. As a result of the liability we recorded a discount to the notes payable. The carrying amount of the notes at the time of issuance was therefore $141,592. The warrant liability (discount) will be amortized over the 45 month duration of the notes payable. The Company will continue to perform a fair value calculation quarterly on the warrant liability and accordingly the warrant liability is increased or decreased based on the fair value calculation. The resulting increase or decrease is reflected in the statement of operations as an unrealized gain or loss on changes in derivative liabilities.

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

 

 

NOTE 8:                  CONVERTIBLE NOTES PAYABLE

 

The following table summarizes the convertible debt outstanding as of December 31, 2017.

 

                           

Carrying amount

 

Date of

 

Maturity

   

Interest

   

Principal at

   

Short term

   

Long term

 

issuance

 

date

   

rate

   

December 31, 2017

   

Related

   

Non related

   

Related

   

Non related

 

3/26/1999

 

6/30/2004

      10%     $ 50,000     $ -0-     $ 50,000     $ -0-     $ -0-  

8/29/2008

 

4/1/2019

      10%       150,000       -0-       -0-       -0-       150,000  

8/29/2008

 

4/1/2020

      10%       1,770,000       -0-       -0-       1,770,000       -0-  

12/16/2008

 

4/1/2020

      12%       4,000,000       -0-       -0-       4,000,000       -0-  

12/16/2008

 

4/1/2021

      12%       200,000       -0-       -0-       -0-       200,000  

Total

                  $ 6,170,000     $ -0-     $ 50,000     $ 5,770,000     $ 350,000  

 

The following table summarizes the convertible debt outstanding as of December 31, 2016.

 

                           

Carrying amount

 

Date of

 

Maturity

   

Interest

   

Principal at

   

Short term

   

Long term

 

issuance

 

date

   

rate

   

December 31, 2016

   

Related

   

Non related

   

Related

   

Non related

 

3/26/1999

 

6/30/2004

      10%     $ 50,000     $ -0-     $ 50,000     $ -0-     $ -0-  

8/29/2008

 

4/1/2018

      10%       150,000       -0-       -0-       -0-       150,000  

8/29/2008

 

4/1/2020

      10%       1,770,000       -0-       -0-       1,770,000       -0-  

12/16/2008

 

4/1/2018

      12%       200,000       -0-       -0-       -0-       200,000  

12/16/2008

 

4/1/2020

      12%       100,000       -0-       -0-       -0-       100,000  

12/16/2008

 

4/1/2020

      12%       4,055,000       -0-       -0-       4,055,000       -0-  

9/30/2009

 

4/1/2018

      12%       100,000       -0-       -0-       -0-       100,000  

9/30/2009

 

4/1/2020

      12%       625,000       -0-       -0-       -0-       625,000  

Total

                  $ 7,050,000     $ -0-     $ 50,000     $ 5,825,000     $ 1,175,000  

 

 

10% Convertible Notes

 

During 1999 the Company issued 10% Convertible Notes payable in the amount of $862,500 pursuant to a Confidential Private Placement Memorandum.   There were costs of $119,625 associated with this offering. The net proceeds to the Company were $742,875.   The notes bear interest at 10% annually, payable semi-annually.  The notes were convertible after maturity, which was June 30, 2004, into shares of common stock of the Company at $1.25 per share. We are in default in the payment of principal and interest. As of December 31, 2017, $812,500 of the Convertible Notes had been repaid in cash or converted into 1,495,179 shares of common stock of the Company leaving an outstanding principal balance of $50,000.   There was $93,210 of accrued interest at December 31, 2017.

 

Secured Convertible Debentures

 

On September 30, 2009 the Company sold an aggregate of $1,400,000 principal amount 12% Secured Convertible Debentures (the “Debentures”) and common stock purchase warrants (the “Warrants”) to purchase an aggregate of 5,600,000 shares of our common stock exercisable at a price of $0.25 per share for four years subsequent to the closing of the transaction to four accredited investors including our then  Chief Executive Officer and Director, Cornelis F. Wit (“Mr. Wit”).   The Company received net proceeds of $1,400,000.   The Debentures, which bear interest at 12% per annum, matured on March 30, 2011. The Debentures are convertible at any time at the option of the holder into shares of our common stock based upon a conversion rate of $0.25 per share.  

 

On March 30, 2011 the Company repaid $200,000 of the outstanding principal amounts owed and extended $1,200,000 of the Debentures until April 1, 2013, including $1,100,000 held by Mr. Wit. The Company also extended the expiration date of the warrants associated with the Debentures.  

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

On February 22, 2013 the Company and two holders extended $1,200,000 of the Debentures until January 1, 2016, including $1,100,000  of the Debentures held by Mr. Wit. The expiration date of the warrants associated with the Debentures was also extended to January 1, 2016.

 

On January 31, 2015 the Company and Mr. Wit extended the maturity date of $1,100,000 of the Debentures to April 1, 2017.   The expiration date of the warrants associated with the Debentures was also extended to April 1, 2017. On November 19, 2015 Mr. Wit converted $475,000 of the Debentures into 1,900,000 shares of our common stock. On November 19, 2015 the Company and Mr. Wit agreed to cancel the 1,900,000 warrants related to the $475,000 of Debentures and $475,000 of unrelated promissory notes in exchange for 1,900,000 shares of our common stock. On November 23, 2015 Mr. Wit sold the remaining $625,000 of Debentures and the related warrants to two unrelated non-affiliate stockholders.

 

On April 1, 2015 the Company and the holder extended the maturity date of $100,000 of convertible debentures to April 1, 2018. The expiration date of the warrants associated with the debentures was also extended to April 1, 2018. On June 30, 2017 the Company repaid the $100,000 of Debentures in full.

 

On June 30, 2016 the Company and two holders extended the maturity date of $625,000 of convertible debentures to April 1, 2020. The expiration date of the warrants associated with the debentures was also extended to April 1, 2020. In August 2017 the Company repaid the $625,000 of Debentures in full.


Convertible Debentures

 

August 2008

On August 29, 2008 the Company sold $2,270,000 of convertible debentures and warrants to purchase an aggregate of 4,540,000 shares of our common stock to four accredited investors including our then  Chief Executive Officer and Director, Cornelis F. Wit and one of our then Directors. The convertible debentures, which bear interest at 10% per annum, were due on August 29, 2010. The convertible debentures are convertible at any time at the option of the holder into shares of our common stock based upon a conversion rate of $0.50 per share.

 

On September 30, 2009 the Company and two Affiliates of the Company extended the maturity date of  $1,920,000 of the convertible debentures until August 29, 2013 in accordance with the terms of a Secured Convertible Debenture issued on that date.

 

On February 22, 2013 the Company and Mr. Wit extended the maturity date of $1,770,000 o f the convertible debentures to January 1, 2016. The expiration date of the warrants associated with the debentures was also extended to January 1, 2016.

 

On February 22, 2013 the Company and our then  Director, Guus van Kesteren (“Mr. van Kesteren”) extended the maturity date of $150,000 of the convertible debentures to January 1, 2015. The expiration date of the warrants associated with the debentures was also extended to January 1, 2015.

 

On April 21, 2014 the Company and Mr. van Kesteren extended the maturity date of $150,000 of the convertible debentures to April 1, 2016. The expiration date of the warrants associated with the debentures was also extended to April 1, 2016. On July 31, 2014 Mr. van Kesteren’s term on the Board of Directors ended. Effective on the same date, his convertible note in the amount of $150,000 was reclassified from Related Party to Non-Related Party.

 

On January 31, 2015 the Company and Mr. Wit extended the maturity date of $ 1,770,000 of the convertible debentures to April 1, 2017. The expiration date of the warrants associated with the debentures was also extended to April 1, 2017.

 

On June 30, 2015 the Company and Mr. van Kesteren extended the maturity date of $150,000 of the convertible debentures t April 1, 2017.   The expiration date of the warrants associated with the debentures was also extended to April 1, 2017.

 

On June 30, 2016 the Company and Mr. Wit extended the maturity date of $1,770,000 of the convertible debentures to April 1, 2020. The expiration date of the warrants associated with the debentures was also extended to April 1, 2020.

 

On June 30, 2016 the Company and Mr. van Kesteren extended the maturity date of $150,000 of the convertible debentures to April 1, 2018. The expiration date of the warrants associated with the debentures was also extended to April 1, 2018.

 

On June 30, 201 7 the Company and Mr. van Kesteren extended the maturity date of $150,000 of the convertible debentures to April 1, 2019. The expiration date of the warrants associated with the debentures was also extended to April 1, 2019.

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

December 2008

On December 16, 2008 the Company sold $5,075,000 of convertible debentures and warrants to purchase an aggregate of 10,150,000 shares of our common stock to eleven accredited investors including our then Chief Executive Officer and Director, Cornelis F. Wit (“Mr. Wit”), our then Chief Operating Officer and President, Stephen E. Johnson (“Mr. Johnson”), our then Chairman and Chief Technology Officer, Randall G. Smith (“Mr. Smith”), our then Chief Financial Officer, Ronald T. Linares, and four of our then Directors. The convertible debentures, which bear interest at 12% per annum, were due on December 16, 2010. The convertible debentures are convertible at any time at the option of the holder into shares of our common stock based upon a conversion rate of $0.50 per share.

 

On September 30, 2009 the Company and eight  Affiliates of the Company extended the maturity date of  $4,980,000 of the Convertible Notes until December 16, 2013 in accordance with the terms of a Secured Convertible Debenture issued on that date.

 

On February 22, 2013 the Company and the holders extended the maturity date of $4,505,000 of the convertible debentures including $4,475,000 due to Mr. Wit, $25,000 due to Mr. Johnson, and $5,000 due to Mr. Smith, to January 1, 2016. The expiration date of the warrants associated with the debentures was also extended to January 1, 2016. On May 1, 2015 the $5,000 of convertible debentures to Mr. Smith were repaid in full.

 

On February 27, 2013 the Company and our former director Mr. Veatch ("Mr. Veatch") extended the maturity date of $15,000 of the convertible debentures  to January 1, 2016. The expiration date of the warrants associated with the debentures was also extended to January 1, 2016.

 

On March 6, 2013 the Company and the holder extended the maturity date of $200,000 of the convertible debentures to January 1, 2014. The expiration date of the warrants associated with the debentures was also extended to January 1, 2014.

 

On March 12, 2013 the Company and the holder extended the maturity date of $100,000 of the convertible debentures to January 1, 2015. The expiration date of the warrants associated with the debentures was also extended to January 1, 2015.

 

In December 2013 the Co mpany and two holders extended the maturity date of $360,000 of the convertible debentures, including $160,000 due to our then Director, Guus van Kesteren (“Mr. van Kesteren”), to January 1, 2016. The expiration date of the warrants associated with the debentures was also extended to January 1, 2016. On July 31, 2014 Mr. van Kesteren’s term on the Board of Directors ended. Effective on the same date, his convertible note in the amount of $160,000 was reclassified from Related Party to Non-Related Party.

 

On April 28, 2014 the Company and the holder extended the maturity date of $100,000 of the convertible debentures to  April 1, 2016.   The expiration date of the warrants associated with the debentures was also extended to April 1, 2016.

 

On January 31, 2015 the Company and Mr. Wit extended the maturity date of $4,475,000 of the convertible debentures to  April 1, 2017.   The expiration date of the warrants associated with the debentures was also extended to April 1, 2017. On November 19, 2015 the Company and Mr. Wit agreed to cancel $420,000 of the debentures and 1,680,000 of unrelated warrants in exchange for 1,680,000 shares of our common stock.

 

On April 27, 2015 the Company and the holder extended the maturity date of $200,000 of the convertible debentures to A pril 1, 2018.   The expiration date of the warrants associated with the debentures was also extended to April 1, 2018.

 

On April 30, 2015 the Company and Mr. Johnson extended the maturity date of $25,000 of the convertible debentures to April 1, 2018. The expiration date of the warrants associated with the debentures was also extended to April 1, 2018. The $25,000 of convertible debentures were repaid in full on December 14, 2016.

 

On May 1, 2015 the Company and Mr. van Kesteren extended the maturity date of $160,000 of the convertible debentures to  April 1, 2017. The expiration date of the warrants associated with the debentures was also extended to April 1, 2017.

 

On May 7, 2015 the Company and Mr. Veatch extended the maturity date of $15,000 of the convertible debentures to A pril 1, 2018.   The expiration date of the warrants associated with the debentures was also extended to April 1, 2018. The $15,000 of convertible debentures were repaid in full on December 14, 2016.

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

On June 30, 2015 the Company and the holder extended the maturity date of $100,000 of the convertible debentures to  April 1, 2017.   The expiration date of the warrants associated with the debentures was also extended to April 1, 2017.

 

On June 30, 2016 the Company and Mr. Wit extended the maturity date of $4,055,000 of the convertible debentures to April 1, 2020. The expiration date of the warrants associated with the debentures was also extended to April 1, 2020. On August 31, 2017 the Company repaid $55,000  of the convertible debentures to Mr. Wit.

 

On June 30, 2016 the Company and Mr. van Kesteren extended the maturity date of $160,000 of the convertible debentures to April 1, 2018. The expiration date of the warrants associated with the debentures was also extended to April 1, 2018. The $160,000 of the convertible debentures were repaid in full on December 14, 2016.

 

On June 30, 2016 the Company and the holder extended the maturity date of $100,000 of the convertible debentures to April 1, 2020. The expiration date of the warrants associated with the debentures was also extended to April 1, 2020. The $100,000 of the convertible debentures were repaid in full on August 31, 2017.

 

On June 30, 2017  the Company and the holder extended the maturity date of $200,000 of the convertible debentures to April 1, 2021. The expiration date of the warrants associated with the debentures was also extended to April 1, 2021.

 

The payments required at maturity under the Company ’s outstanding convertible debt at December 31, 2017 are as follows:

 

Year

 

Amount

 

2018

  $ 50,000  

2019

    150,000  

2020

    5,770,000  

2021

    200,000  

Total

  $ 6,170,000  

 

 

NOTE 9 :              FAIR VALUE MEASUREMENT

 

The Company measures the fair value of its assets and liabilities under the guidance of ASC 820, Fair Value Measurements and Disclosures , which defines fair value, establishes a framework for measuring fair value in accordance with generally accepted accounting principles and expands disclosures about fair value measurements. ASC 820 does not require any new fair value measurements, but its provisions apply to all other accounting pronouncements that require or permit fair value measurement.

 

ASC 820 clarifies that fair value is an exit price, representing the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants based on the highest and best use of the asset or liability. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. ASC 820 requires the Company to use valuation techniques to measure fair value that maximize the use of observable inputs and minimize the use of unobservable inputs. These inputs are prioritized as follows:

 

 

Level 1: Observable inputs such as quoted prices for identical assets or liabilities in active markets;

 

 

Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly such as quoted pri ces for similar assets or liabilities or market-corroborated inputs; and

 

 

Level 3: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions about how market participants would price the assets or liabilities.

 

The valuation techniques that may be used to measure fair value are as follows:

 

 

Market approach - Uses prices and other relevant information generated by market transactions involving identical or comparable assets or liabilit ies

 

 

Income approach - Uses valuation techniques to convert future amounts to a single present amount based on current market expectations about those future amounts, including present value techniques, option-pricing models and excess earnings method

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

 

Cos t approach - Based on the amount that currently would be required to replace the service capacity of an asset (replacement cost)

 

  The Company also adopted the provisions of ASC 825, Financial Instruments . ASC 825 allows companies to choose to measure eligible assets and liabilities at fair value with changes in value recognized in earnings. Fair value treatment may be elected either upon initial recognition of an eligible asset or liability or, for an existing asset or liability, if an event triggers a new basis of accounting. The Company did not elect to re-measure any of its existing financial assets or liabilities under the provisions of this Statement and did not elect the fair value option for any financial assets and liabilities transacted in the years ended December 31, 2017 and December 31, 2016.

 

The Company ’s financial assets or liabilities subject to ASC 820 as of December 31, 2017 include the conversion feature and warrant liability associated with convertible debentures issued during fiscal 2008 and 2009, the warrants issued during 2011 and 2016 that are associated with notes payable and the value of Intellectual Property and a customer list associated with the acquisition of Promasys B. V. during 2013. The conversion feature and warrants were deemed to be derivatives (the “Derivative Instruments”) since a fixed conversion price cannot be determined for either of the Derivative Instruments due to anti-dilution provisions embedded in the offering documents for the convertible debentures.  The derivative instruments were not issued for risk management purposes and as such are not designated as hedging instruments under the provisions of ASC 815 Disclosures about Derivative Instruments and Hedging Activities .  See Note 8 – Convertible Notes Payable.

 

Following is a description of the valuation methodologies used to determine the fair value of the Company ’s financial assets including the general classification of such instruments pursuant to the valuation hierarchy.

 

A summary as of December 31, 2017 of the fair value of liabilities measured at fair value on a recurring basis follows:

 

   

Fair value at

   

Quoted prices in

active markets for

identical

assets/liabilities

   

Significant other

observable inputs

   

Significant

unobservable inputs

 
   

December 31, 2017

   

(Level 1)

   

(Level 2)

   

(Level 3)

 

Derivatives: (1) (2)

                               

Conversion feature liability

  $ 1,685,947     $ -0-     $ -0-     $ 1,685,947  

Warrant liability

    3,440,799       -0-       -0-       3,440,799  

Total of derivative liabilities

  $ 5,126,746     $ -0-     $ -0-     $ 5,126,746  

 

( 1 ) The fair value of the derivative instruments was estimated using the Income Approach and the Black Scholes option pricing model with the following assumptions for the year ended December 31, 2017

 

( 2 ) The fair value at the measurement date is equal to the carrying value on the balance sheet

 

 

Significant valuation assumptions for derivative instruments at December 31, 2017

 

Risk free interest rate

    1.56% to 1.81%  

Dividend yield

      0.00%    

Expected volatility

    87.0% to 118.4%  

Expected life (range in years)

           

Conversion feature liability

    1.25 to 3.25  

Warrant liability

    0.25 to 3.25  

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

A summary as of December 31, 2017 of the fair value of assets measured at fair value on a nonrecurring basis follows:

 

   

Carrying amount

   

Carrying amount

   

Quoted prices in

active markets

for identical

assets/ liabilities

   

Significant other

observable inputs

   

Significant

unobservable inputs

 
   

December 31, 2016

   

December 31, 2017

   

(Level 1)

   

(Level 2)

   

(Level 3)

 

Acquired assets (3)

                                       

Promasys B.V. customer list (4)

  $ 82,173     $ 85,786     $ -0-     $ -0-     $ 136,253  

Promasys B.V. software code (4)

    26,707       12,139       -0-       -0-       72,943  

Total

  $ 108,880     $ 97,925     $ -0-     $ -0-     $ 209,196  

 

( 3 ) The fair value of the acquired assets was estimated using the Income Approach with a discounted cash flow valuation methodology applied.

 

( 4 ) The acquired Promasys B.V. customer list and software code are not measured on a recurring basis since their initial fair value has been deemed to have a finite life and is being amortized periodically. Instead the Company performs an impairment analysis on a quarterly basis in order to determine whether the carrying value of the assets reflects the fair value of the assets in a market based transaction.

 

A summary as of December 31, 2016 of the fair value of liabilities measured at fair value on a recurring basis follows:

 

   

Fair value at

   

Quoted prices in active

markets for identical

assets/ liabilities

   

Significant other

observable inputs

   

Significant

unobservable inputs

 
   

December 31, 2016

   

(Level 1)

   

(Level 2)

   

(Level 3)

 

Derivatives: (1) (2)

                               

Conversion feature liability

  $ 2,325,730     $ -0-     $ -0-     $ 2,325,730  

Warrant liability

    3,999,362       -0-       -0-       3,999,362  

Total of derivative liabilities

  $ 6,325,092     $ -0-     $ -0-     $ 6,325,092  

 

( 1 ) The fair value of the derivative instruments was estimated using the Income Approach and the Black Scholes option pricing model with the following assumptions for the year ended December 31, 2016

( 2 ) The fair value at the measurement date is equal to the carrying value on the balance sheet

 

Significant valuation assumptions for derivative instruments at December 31, 2016

 

Risk free interest rate

    0.82% to 1.45%  

Dividend yield

      0.00%    

Expected volatility

    117.3% to 143.8%  

Expected life (range in years)

           

Conversion feature liability

    1.25 to 3.25  

Warrant liability

    0.25 to 3.25  

 

A summary as of December 31, 2016 of the fair value of assets measured at fair value on a nonrecurring basis follows:

 

   

Carrying amount

   

Carrying amount

   

Quoted prices in

active markets

for identical

assets/ liabilities

   

Significant other

observable inputs

   

Significant

unobservable

inputs

 
   

December 31, 2015

   

December 31, 2016

   

(Level 1)

   

(Level 2)

   

(Level 3)

 

Acquired assets (3)

                                       

Promasys B.V. customer list (4)

  $ 92,444     $ 82,173     $ -0-     $ -0-     $ 136,253  

Promasys B.V. software code (4)

    41,274       26,707       -0-       -0-       72,943  

Promasys B.V. URLs/website (4)

    15,159       -0-       -0-       -0-       68,814  

Total

  $ 148,877     $ 108,880     $ -0-     $ -0-     $ 278,010  

 

( 3 ) The fair value of the acquired assets was estimated using the Income Approach with a discounted cash flow valuation methodology applied.

 

( 4 ) The acquired Promasys B.V. software code, customer list and URLs/website are not measured on a recurring basis since their initial fair value has been deemed to have a finite life and is being amortized periodically. Instead the Company performs an impairment analysis on a quarterly basis in order to determine whether the carrying value of the assets reflects the fair value of the assets in a market based transaction.

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

Other identifiable intangible assets, which are subject to amortization, are being amortized using the straight-line method over their estimated useful lives ranging from 3 to 15 years. The Impairment or Disposal of Long-Lived Asset subsection of the Property, Plant and Equipment Topic of the FASB ASC, requires us to test the recoverability of long-lived assets, including identifiable intangible assets with definite lives, whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. In testing for potential impairment, if the carrying value of the asset group exceeds the expected undiscounted cash flows, we must then determine the amount by which the fair value of those assets exceeds the carrying value and determine the amount of impairment, if any.

 

   

Other income/(expense)

 
   

For the year ended

 
   

December 31, 2017

   

December 31, 2016

 

The net amount of gains/(losses) for the period included in earnings attributable to the unrealized and realized gain/(losses) from changes in derivative liabilities at the reporting date

  $ 795,779     $ (2,657,910 )
                 

Total unrealized and realized gains/(losses) included in earnings

  $ 795,779     $ (2,657,910 )

 

The tables below set forth a summary of changes in fair value of the Company ’s Level 3 financial liabilities at fair value for the years ended December 31, 2017 and December 31, 2016. The tables reflect gains and losses for all financial liabilities at fair value categorized as Level 3 as of December 31, 2017 and December 31, 2016.

 

   

Level 3 financial liabilities at fair value

 
                           

Net

   

Reclassification

         
                           

purchases,

   

of conversion

         
   

Balance,

                   

issuances

   

feature liability

   

Balance,

 

For the year ended

 

beginning

   

Net realized

   

Net unrealized

   

and

   

associated with

   

end

 

December 31, 2017

 

of year

   

gains/(losses)

   

gains/(losses)

   

settlements

   

convertible debt

   

of year

 

Derivatives:

                                               

Conversion feature liability

  $ (2,325,730 )   $ 48,375     $ 188,841     $ -0-     $ 402,567     $ (1,685,947 )

Warrant liability

    (3,999,362 )     -0-       558,563       -0-       -0-       (3,440,799 )

Total of derivative liabilities

  $ (6,325,092 )   $ 48,375     $ 747,404     $ -0-     $ 402,567     $ (5,126,746 )

 

 

   

Level 3 financial liabilities at fair value

 
                           

Net

                 
                           

purchases,

                 
   

Balance,

                   

issuances

           

Balance,

 

For the year ended

 

beginning

   

Net realized

   

Net unrealized

   

and

   

Net transfers

   

end

 

December 31, 2016

 

of year

   

gains/(losses)

   

gains/(losses)

   

settlements

   

in and/or out

   

of year

 

Derivatives:

                                               

Conversion feature liability

  $ (901,243 )   $ 29,108     $ (1,453,595 )   $ -0-     $ -0-     $ (2,325,730 )

Warrant liability

    (1,914,923 )     -0-       (1,233,423 )     (851,016 )     -0-       (3,999,362 )

Total of derivative liabilities

  $ (2,816,166 )   $ 29,108     $ (2,687,018 )   $ (851,016 )   $ -0-     $ (6,325,092 )

 

 

 

NOTE 1 0 :               COMMITMENTS AND CONTINGENCIES

 

The Company currently leases office space under operating leases for its office locations and has several operating leases related to server and network co-location and disaster recovery for its operations.   The minimum future lease payments required under the Company’s operating leases at December 31, 2017 are as follows:

 

Year

 

Payments

 

2018

  $ 651,376  

2019

    475,638  

2020

    339,287  

2021

    269,962  

2022

    266,000  

Thereafter

    44,549  

Total

  $ 2,046,812  

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

In addition to annual base rental payments, the Company pays for the operating expenses associated with its leased office space and is responsible for any escalation in operating expenses as determined in the leases.   Rent expense was $1,125,147 for the year ended December 31, 2017 and $1,071,363 for the year ended December 31, 2016.

 

The Company ’s corporate office lease expires in February 2023.   The Company’s lease on its New Jersey field office expires in March 2021.   The Company currently operates its wholly-owned subsidiary, OmniComm Ltd., in the United Kingdom under the terms of a lease that expires in September 2020.   The Company currently operates its wholly-owned subsidiary, OmniComm Europe, GmbH, in Germany under the terms of a lease that expires in July 2018. The Company currently operates its wholly-owned subsidiary, OmniComm Systems B.V., in the Netherlands under the terms of a lease that expires in October 2018.

 

LEGAL PROCEEDINGS

 

From time to time the Company may be involved in litigation relating to claims arising out of our operations in the normal course of business. As of December 31, 2017, there were no pending or threatened lawsuits that could reasonably be expected to have a material effect on the results of our operations.

 

PATENT LITIGATION SETTLEMENT

 

Effective April 2, 2009, we entered into a Settlement and Licensing Agreement with DataSci, LLC (“DataSci”) which relates to a lawsuit filed on June 18, 2008 in the United States District Court for the District of Maryland by DataSci against OmniComm alleging infringement of U.S. Patent No. 6,496,827 B2 entitled “Methods and Apparatus for the Centralized Collection and Validation of Geographically Distributed Clinical Study Data with Verification of Input Data to the Distributed System” (“Licensed Patent”) owned by DataSci. Pursuant to the Settlement and Licensing Agreement, the parties entered into a Stipulated Order of Dismissal of the lawsuit filed by DataSci and DataSci (i) granted us a worldwide, non-exclusive non-transferable right and license under the Licensed Patent the subject of the claim for the Licensed Products and the right to sublicense TrialMaster on a Technology Transfer and Technology Transition basis , and (ii) released us from any and all claims of infringement of the Licensed Patent which may have occurred prior to the effective date of the Settlement and Licensing Agreement. Licensed Products is defined as all products and services of OmniComm and of its subsidiaries in the field of electronic data capture, whether sold by OmniComm directly or through its affiliates, parents, subsidiaries, partners, vendors, agents and/or representatives, including TrialMaster, products and services or other products and services that perform the substantially equivalent function of TrialMaster, and any other products and services that OmniComm may develop in the future in the field of electronic data capture. The license expressly excludes the right to make, use, sell, import, market, distribute, oversee the operation of, or service systems covered by a claim (if any) of the Licensed Patent to the extent such systems are used for creating and managing source documentation and conducting remote data validation in clinical trial studies using a tablet PC with stylus, touch screen device, digitizing tablet, digitizer pen or similar mobile processing device (“Digitizing Device”), wherein the source documentation is electronic and is completed using a Digitizing Device. Under the terms of the license, we were obligated to pay royalties quarterly for sales of Licensed Products from January 1, 2008 until December 31, 2017 in the amount of the greater of two percent ( 2% ) of our annual gross revenues from Licensed Products or, alternatively, the annual minimum royalty payment(s). The Settlement and Licensing Agreement and the amendment thereto (described below) could be terminated on thirty ( 30 ) days’ notice by the licensor if we were in default on our obligations thereunder and failed to cure such default within the thirty ( 30 ) day period after notice is provided. In addition to the payment of royalties, the Settlement and Licensing Agreement imposed certain obligations on us including commercialization, certain sublicensing, other payments, insurance, and confidentiality. In addition and as a license fee for past use of the Licensed Patent which may have occurred prior to the effective date of the Settlement and Licensing Agreement, we issued a warrant to DataSci to purchase 1,000,000 shares of our common stock at an exercise price of $.01 per share.  The Settlement and Licensing Agreement provides that upon the expiration date of the warrant, at DataSci’s sole discretion, DataSci shall exercise its option under the warrant or licensee shall pay DataSci $300,000. The warrant was exercisable commencing on the second anniversary of the Settlement and Licensing Agreement, April 2, 2011, through the expiration date of the warrant on December 31, 2017. On December 31, 2017 DataSci exercised 50% of the warrant for 500,000 common shares and requested cash payment on 50% of the warrant. As a result of the exercise, DataSci received 500,000 restricted common shares and a net cash payment of $145,000.

 

The remaining minimum royalty payments per year are as follows:

 

Year

 

Payment

 

2018

  $ 112,500  

Total

  $ 112,500  

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

On June 23, 2009, we entered into an agreement to acquire the EDC assets of eResearch Technology.   Concurrent with the consummation of that transaction we entered into the First Amendment to Settlement and Licensing Agreement with DataSci, (i) to include the eResearch Technology EDC assets acquired within the definition of Licensed Products, and as such subject to the royalty payment(s), under and in accordance with the Settlement and Licensing Agreement, and (ii) provide a release by DataSci of any and all claims of infringement of the Licensed Patent in connection with the eResearch Technology EDC assets acquired which may have occurred prior to the effective date of the First Amendment to Settlement and Licensing Agreement for an aggregate of $300,000.

 

The Company recorded a credit to earnings of   $108,702 during the year ended December 31, 2017 and a charge of $94,129 during the year ended December 31, 2016,   which amounts represent ( 1 ) the amount of additional license expense incurred above the stipulated minimum in the DataSci License Agreement during the years ended December 31, 2017 and December 31, 2016 and ( 2 ) the accretion of the difference between the total stipulated annual minimum royalty payments and the recorded present value accrual of the annual minimum royalty payments.

 

EMPLOYMENT AGREEMENTS

 

The Company has employment agreements in place with the following members of our executive management team:

 

Cornelis F. Wit, Executive Chairman

 

Randall G. Smith, Executive Vice Chairman

 

Stephen E. Johnson, Chief Executive Officer  and President

 

Thomas E. Vickers, Chief Financial Officer

 

The employment agreements provide, among other things, for participation in employee benefits available to employees and executives. Each of the agreements will renew for successive one -year terms unless the agreement is expressly cancelled by either the employee or the Company ninety days prior to the end of the term. Under the terms of the agreement, the Company may terminate the employee’s employment upon 30 days notice of a material breach and the employee may terminate the agreement under the same terms and conditions. The employment agreements contain non-disclosure and severance provisions, as well as non-compete clauses.

   

 

NOTE 1 1 :              RELATED PARTY TRANSACTIONS

 

On April 1, 2015 the Company issued a promissory note in the amount of $20,000 to our then Chairman and Chief Technology Officer, Randall G. Smith (“Mr. Smith”), in exchange for an existing promissory note in the same amount.  The promissory note carries an interest rate of 12% and has a maturity date of April 1, 2018. The note was repaid in full on December 14, 2016.

 

On April 30, 2015, the Company and Mr. Johnson extended the maturity date of $25,000 of convertible debentures to our then Chief Operating Officer and President, Stephen E. Johnson, originally issued in December 2008. The debentures carry an interest rate of 12% and have a maturity date of April 1, 2018. The expiration date of the warrants associated with the debentures was also extended to April 1, 2018. The convertible debentures were repaid in full on December 14, 2016.

 

As of December 31, 2017, the Company has an aggregate of $5,770,000 of convertible debentures and $400,000 of promissory notes to our Executive Chairman and Chairman of the Board, Cornelis F. Wit (“Mr. Wit”), and have issued certain warrants to Mr. Wit, as follows:

 

In June 2008, Mr. Wit invested $510,000 in convertible notes. On August 29, 2008, Mr. Wit converted the $510,000 and invested an additional $1,260,000 in a private placement of convertible debentures and warrants to purchase 3,540,000 shares of our common stock. The convertible debentures, which bear interest at 10% per annum, were due on August 29, 2010. The convertible debentures are convertible at any time at the option of the holder into shares of our common stock based upon a conversion rate of $0.50 per share. On September 30, 2009, the Company and Mr. Wit extended the $1,770,000 of convertible debentures until August 29, 2013 in accordance with the terms of a Secured Convertible Debenture issued on that date. On February 22, 2013, the Company and Mr. Wit extended the maturity date of the $1,770,000 of convertible debentures to January 1, 2016. The expiration date of the warrants associated with the debentures was also extended to January 1, 2016. On January 31, 2015 the Company and Mr. Wit extended the maturity date of the $1,770,000 of convertible debentures to April 1, 2017. The expiration date of the warrants associated with the debentures was also extended to April 1, 2017. On June 30, 2016 the Company and Mr. Wit extended the maturity date of the $1,770,000 of convertible debentures to April 1, 2020. The expiration date of the warrants associated with the debentures was also extended to April 1, 2020.

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

In February 2008, Mr. Wit invested $150,000 in promissory notes and from September 2008 to December 2008, Mr. Wit invested $4,200,000 in convertible notes. On December 16, 2008, Mr. Wit converted the $4,350,000 into a private placement of convertible debentures and warrants to purchase 8,700,000 shares of our common stock. The convertible debentures, which bear interest at 12% per annum, were due on December 16, 2010. The convertible debentures are convertible at any time at the option of the holder into shares of our common stock based upon a conversion rate of $0.50 per share. On September 30, 2009, the Company and Mr. Wit extended the $4,350,000 of convertible debentures until December 16, 2013 in accordance with the terms of a Secured Convertible Debenture issued on that date. In a private transaction on October 16, 2012, Mr. Wit purchased $125,000 of the December 2008 convertible debentures and the related 250,000 warrants from Mr. Ronald Linares, the Company’s former Chief Financial Officer. On February 22, 2013, the Company and Mr. Wit extended the maturity date of the $4,475,000 of convertible debentures to January 1, 2016. The expiration date of the warrants associated with the debentures was also extended to January 1, 2016. On January 31, 2015 the Company and Mr. Wit extended the maturity date of the $4,475,000 of convertible debentures to April 1, 2017. The expiration date of the warrants associated with the debentures was also extended to April 1, 2017. On November 19, 2015 the Company and Mr. Wit agreed to cancel $420,000 of the debentures and 1,680,000 of unrelated warrants in exchange for 1,680,000 shares of our common stock . On June 30, 2016 the Company and Mr. Wit extended the maturity date of the $4,055,000 of convertible debentures to April 1, 2020. The expiration date of the warrants associated with the debentures was also extended to April 1, 2020. On August 31, 2017, the Company repaid $55,000 to Mr. Wit.

 

On February 29, 2016, the Company issued a promissory note in the principal amount of $450,000 and warrants to purchase 1,800,000 shares of common stock of the Company at an exercise price of $0.25 per share with an expiration date of April 1, 2019 to Mr. Wit in exchange for accrued interest in the amount of $450,000. The note carries an interest rate of 12% per annum and has a maturity date of April 1, 2019. On August 31, 2017, the Company repaid $5 0,000 to Mr. Wit.

 

On March 18, 2013, the Company entered into a $2,000,000 revolving Line of Credit with The Northern Trust Company guaranteed by Mr. Wit. On December 18, 2013 the Company renewed the Line of Credit and increased the available balance to $4,000,000. On February 3, 2015 the Company renewed the Line of Credit and increased the available balance to $5,000,000. On April 7, 2017 the Company renewed the Line of Credit. Mr. Wit receives 2.0% interest (approximately $9,500 per month) on the assets pledged for the Line for Credit. The Line of Credit matures on April 7, 2020 and carries a variable interest rate based on the prime rate. At December 31, 2017, $2,650,000 was outstanding on the Line of Credit at an interest rate of 3.5%.

 

The Company  incurred interest expense payable to related parties of $947,688 for the year ended  December 31, 2017 and $918,189 for the year ended  December 31, 2016.  

 

 

NOTE 1 2 :               STOCKHOLDERS’ (DEFICIT)

 

Our authorized capital stock consists of 5 00,000,000 shares of common stock, $.001 par value per share, and 10,000,000 shares of preferred stock, par value $.001 per share, of which 5,000,000 shares have been designated as 5% Series A Preferred, 230,000 shares have been designated as Series B Preferred Stock, 747,500 shares have been designated as Series C Preferred Stock and 250,000 shares have been designated as Series D Preferred Stock.

 

As of December 31, 2017 we had the following outstanding securities:

 

 

148,542,805  shares of common stock issued and outstanding;

 

27,020,000 warrants issued and outstanding to purchase shares of our common stock;

 

5,275,000  options issued and outstanding to purchase shares of our common stock;

  250,000 Series D Preferred Stock issued and outstanding; and
 

$ 6,170,000 principal amount Convertible Debentures convertible into 12 ,28 0,000 shares of common stock.

 

Common Stock

 

Holders of common stock are entitled to one vote for each share on all matters submitted to a stockholder vote.   Holders of our voting securities do not have cumulative voting rights. Holders of common stock are entitled to share in all dividends that the Board of Directors, in its discretion, declares from legally available funds.  In the event of our liquidation, dissolution or winding up each outstanding share of common stock entitles its holder to participate in all assets that remain after payment of liabilities and after providing for each class of stock, if any, having preference over the common stock.

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

Holders of common stock have no conversion, preemptive or other subscription rights, and there are no redemption provisions for the common stock.   The rights of the holders of common stock are subject to any rights that may be fixed for holders of preferred stock, when and if any preferred stock is outstanding.  All outstanding shares of common stock are duly authorized, validly issued, fully paid and non-assessable.

 

During the first four months of 2016 14,615,696 common shares were issued to the Series A Preferred stockholders who accepted the Series A Preferred Share Exchange Offer.

 

On A pril 13, 2016 an employee exercised stock options granted to the employee. As a result of the exercise, 3,012 common shares were issued to the individual.

 

On A pril 25, 2016 an employee exercised stock options granted to the employee. As a result of the exercise, 1,000,000 common shares were issued to the individual.

 

On A pril 26, 2016 an employee exercised stock options granted to the employee. As a result of the exercise, 1,594 common shares were issued to the individual.

 

On June 1 6, 2016 the Company issued 360,000 restricted shares of our common stock to our Board of Directors under the 2009 Plan. The restrictions on the shares lapse ratably over a 3 year period.

 

On July 20, 2016 an employee exercised stock options granted to the employee. As a result of the exercise, 3,038 common shares were issued to the individual.

 

On December 30, 2016 Thomas E. Vickers, our Chief Financial Officer, exercised stock options granted to him in 2011. As a result of the exercise, 100,000 common shares were issued to him.

 

On March 24, 2017 16,668 restricted shares were forfeited when an employee resigned prior to the lapsing of the restrictions.

 

On June 26, 2017 an employee exercised stock options granted to the employee. As a result of the exercise, 22,556 common shares were issued to the individual.

 

On A ugust 2, 2017  Thomas E. Vickers, our Chief Financial Officer, exercised stock options granted to him in 2012. As a result of the exercise, 100,000 common shares were issued to him.

 

On September 29, 2017 an employee exercised stock options granted to the employee. As a result of the exercise, 50,000 common shares were issued to the individual.

 

On September 29, 2017 Kuno van der Post, our Chief Commercial Officer, exercised stock options granted to him in 2012. As a result of the exercise, 100,000 common shares were issued to him.

 

On December 31, 2017 DataSci exercised 50% of their warrant and as a result 500,000 restricted common shares were issued to DataSci.

 

The 2009 Plan is more fully described in “Note 1 3, Employee Equity Incentive Plans”.

 

Preferred stock

 

Our Board of Directors, without further stockholder approval, may issue preferred stock in one or more series from time to time and fix or alter the designations, relative rights, priorities, preferences, qualifications, limitations and restrictions of the shares of each series. In addition, the Board of Directors may fix and determine all privileges and rights of the authorized preferred stock series including:

 

 

dividend and liquidation preferences,

 

voting rights,

 

conversion privileges, and

 

redemption terms.

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

Our Board of Directors may authorize the issuance of preferred stock which ranks senior to our common stock for the payment of dividends and the distribution of assets on liquidation.   In addition, our Board of Directors can fix limitations and restrictions, if any, upon the payment of dividends on our common stock to be effective while any shares of preferred stock are outstanding.

 

The following table presents the cumulative arrearage of undeclared dividends by class of preferred stock as of December 31, 2017 and December 31, 2016 and the per share amount by class of preferred stock.

 

   

Cumulative arrearage
as of

   

Cumulative arrearage per share
as of

 
   

December 31,

   

December 31,

 

Series of preferred stock

 

2017

   

2016

   

2017

   

2016

 
                                 

Series B

  $ 609,887     $ 609,887     $ 3.05     $ 3.05  

Series C

    1,472,093       1,472,093     $ 4.37     $ 4.37  

Total preferred stock arrearage

  $ 2,081,980     $ 2,081,980                  

 

 

Series A Preferred Stock

 

In 1999, our Board of Directors designated 5,000,000 shares of our preferred stock as 5% Series A Convertible Preferred Stock (“Series A Preferred Stock”), of which - 0 - shares are issued and outstanding.

 

The designations, rights and preferences of the Series A Preferred include:

 

 

the shares are not redeemable,

 

each share of Series A Preferred Stock is convertible into shares of our common stock at any time at the option of the holder at a conversion price of $1. 11 per share, or if not so converted after one year from issuance, at any time at our option if the closing bid price of our common stock has exceeded $3.00 for 20 consecutive trading days, our common stock is listed on The NASDAQ Stock Market or other national stock exchange, and the shares of common stock issuable upon conversion of the Series A Preferred Stock are registered under a registration statement,

 

the conversion price has certain anti-dilution protections for any stock splits, stock dividends, and corporate reorganizations, and certain other corporate transactions and issuances of securities at below the applicable conversion price per share.   The Series A Preferred Stockholders have waived their rights to an anti-dilution adjustment reducing their conversion price as a result of the issuance of the Series B Preferred Stock and Series C Preferred Stock,

 

the shares of Series A Preferred Stock pay a cumulative dividend at a rate of 5% per annum based on the stated value of $1.00 per share, payable when and as declared by the Board of Directors, or upon conversion or liquidation. Dividends on the Series A Preferred Stock have priority to our common stock and are junior to Series B Preferred Stock and Series C Preferred Stock.   At our option, dividends can be paid in cash or shares of common stock valued at the conversion price of the Series A Preferred Stock,

 

in the event of our liquidation or winding up, each share of Series A Preferred Stock has a liquidation preference equal to $1.00 per share, and

 

the holders of the Series A Preferred Stock are entitled to vote together with the holders of our common stock, on the basis of one vote for each share of common stock issuable upon the conversion of the Series A Preferred Stock.

 

In addition, the holders of the Series A Preferred Stock were granted certain demand and piggy-back registration rights for the shares of our common stock issuable upon the conversion of the Series A Preferred Stock.

 

Prior to 2015 the Company had 235,000 shares of its 5% Series A Preferred stock that have been converted by the stockholders into shares of our common stock.  Pursuant to Delaware General Corporate Law, once the Company has a positive net worth, the cumulative dividends would be payable in either cash or in shares of our common stock upon the declaration of dividends by our Board of Directors.

 

In December 2015 the Company initiated an Exchange Offer to the remaining 34 Series A Preferred stockholders. The terms of the exchange offer were 4 shares of our common stock in exchange for each share of Series A Preferred stock and the waiver of the accrued and unpaid dividends on the Series A Preferred shares exchanged. On December 31, 2015 four 5% Series A Preferred Stock Stockholders accepted the Exchange Offer and converted a total of 487,500 Series A shares into 1,950,000 common shares. During the first 4 months of 2016, the remaining Series A Preferred stockholders accepted the Exchange Offer and converted a total of 3,637,724 Series A shares into 14,615,696 common shares.

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

Series B Preferred Stock

 

In August 2001, our Board of Directors designated 200,000 shares of our preferred stock as Series B Convertible Preferred Stock (“Series B Preferred Stock”). A Corrected Certificate of Designations was filed on February 7, 2002 with the Delaware Secretary of State increasing the number of shares authorized as Series B Preferred Stock to 230,000 shares, of which - 0 - shares are issued and outstanding.

 

The designations, rights and preferences of the Series B Preferred Stock include:

 

 

the stated value of each share is $10.00 per share,

 

the shares are not redeemable,

 

each share of Series B Preferred Stock is convertible into shares of our common stock at the option of the holder at any time commencing January 31, 2002 at the option of the holder at $0.25 per share, as adjusted, and the shares automatically convert, subject to limitations based on trading volume, into shares of our common stock at $0.25 per share at such time as we complete a public offering raising proceeds in excess of $25 million at an offering price of at least $0.75 per share.   We may require all outstanding shares of the Series B Preferred Stock to convert in the event the closing bid price of our common stock exceeds $0.50 for 20 consecutive trading days, and our common stock has been listed on The NASDAQ Stock Market or other comparable national stock exchange or an OTC Marketplace and a registration statement registering the shares of common stock issuable upon conversion of the Series B Preferred Stock has been declared effective,

 

the conversion price has certain anti-dilution protections for any stock splits, stock dividends, and corporate reorganizations, and certain other corporate transactions and issuances of securities at below the applicable conversion price per share or market value of the common stock,

 

the shares of Series B Preferred Stock pay a cumulative dividend at a rate of 8% per annum based on the stated value of $10.00 per share, payable when and as declared by the Board of Directors, or upon conversion or liquidation.   At our option, dividends can be paid in cash or shares of common stock valued at the conversion price of the Series B Preferred Stock,

 

  each share of Series B Preferred Stock will rank senior to our Series A Preferred and pari passu with our Series C Preferred Stock,

 

in the event of our liquidation or winding up, each share of Series B Preferred Stock has a liquidation preference equal to $10.00 per share plus accrued and unpaid dividends, and

 

the holders of the Series B Preferred Stock are entitled to vote, together with the holders of our common stock, on the basis of one vote for each share of common stock issuable upon the conversion of the Series B Preferred Stock,

 

There were cumulative arrearages of $609,887 and $609,887, or $3.05 and $3.05 per share, on the Series B Preferred Stock dividends as of December 31, 2017 and December 31, 2016, respectively.

 

The Company has 200,000 shares of its Series B Preferred stock that have been converted by the stockholders into shares of our common stock.  Pursuant to Delaware General Corporate Law, once the Company has a positive net worth, the cumulative dividends would be payable in either cash or in shares of our common stock upon the declaration of dividends by our Board of Directors.

 

In addition, the holders of the Series B Preferred Stock were granted certain mandatory and piggy-back registration rights for the shares of our common stock issuable upon the conversion of the Series B Preferred Stock and were entitled to vote one member to our Board of Directors.

 

Series C Preferred Stock

 

In March 2002, our Board of Directors designated 747,500 shares of our preferred stock as Series C Convertible Preferred Stock of which - 0 - shares are issued and outstanding.

 

The designations, rights and preferences of the Series C Preferred Stock include:

 

 

the stated value of each share is $10.00 per share,

 

the shares are not redeemable,

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

 

each share of Series C Preferred Stock is convertible at any time, at the option of the holder, into a number of shares of common stock determined by dividing the stated value per share of the Series C Preferred Stock by $0.25, which is the Series C Conversion Price.   The Series C Preferred Stock will automatically convert, subject to limitations based on trading volume, into shares of our common stock upon a public offering of our securities raising gross proceeds in excess of $25,000,000 at a per share price greater than 2.5 times the Series C Conversion Price per share, as adjusted for any stock split, stock dividend, recapitalization, or other similar transaction.  In addition, the Series C Preferred Stock will automatically convert into shares of our common stock at the Series C Conversion Price at such time as the closing bid price for our common stock has traded at two times the then prevailing Series C Conversion Price for a period of 20 consecutive trading days, provided that (i) a public trading market exists for our common stock on a national securities exchange, the NASDAQ Stock Market, or the over the counter market; and (ii) the Conversion Shares have been registered for resale and are not subject to any lock-up and the number of shares of the Series C Preferred Stock which can be converted in any 30 -day period will be limited to the number of shares of common stock underlying the Series C  Preferred Stock equal to 10 times the average daily trading volume during the 20 -day look-back period set forth above,

 

the conversion price   has certain anti-dilution protections for any stock splits, stock dividends, and corporate reorganizations, and certain other corporate transactions and issuances of securities at below the applicable conversion price per share or market value of the common stock,

 

the shares of Series C Preferred Stock pay a cumulative dividend at a rate of 8% per annum based on the stated value of $10.00 per share, payable when and as declared by the Board of Directors, or upon conversion or liquidation.   At our option, dividends can be paid in cash or shares of common stock valued at the conversion price of the Series C Preferred Stock,

 

each share of Series C Preferred Stock will rank pari passu with our Series B   Preferred Stock and senior to our Series A  Preferred Stock,

 

in the event of our liquidation or winding up, each share of Series C Preferred Stock   has a liquidation preference equal to $10.00 per share plus accrued and unpaid dividends, and

 

the holders of the Series C Preferred Stock are entitled to vote, together with the holders of our common stock, on the basis of one vote for each share of common stock issuable upon the conversion of the Series C Preferred Stock.

 

There were cumulative arrearages of $1,472,093 and $1,472,093, or $4.3 7 and $4.37 per share, on the Series C Preferred Stock for undeclared dividends as of December 31, 2017 and December 31, 2016, respectively.

   

The Company has 337,150 shares of its Series C Preferred stock that have been converted by the stockholders into shares of our common stock.  Pursuant to Delaware General Corporate Law, once the Company has a positive net worth, the cumulative dividends would be payable in either cash or in shares of our common stock upon the declaration of dividends by our Board of Directors.

 

In addition, the holders of the Series C Preferred Stock were granted certain mandatory and piggy-back registration rights covering the shares of our common stock issuable upon the conversion of the Series C Preferred Stock and were entitled to vote two members to our Board of Directors.

 

Series D Preferred Stock

 

In November 2010, our Board of Directors designated 250,000 shares of our preferred stock as Series D Convertible Preferred Stock of which 250,000 shares are issued and outstanding.

 

The designations, rights and preferences of the Series D Preferred Stock include:

 

 

the stated value of the Series D Preferred is $0.001 per share,

 

the Series D Preferred has no rights to receive dividend distributions or to participate in any dividends declared by the Corporation to or for the benefit of the holders of its common stock,

 

the shares of Series D Preferred are not convertible into or exchangeable for any ot her security of the Corporation,

 

except as provided in Series D Preferred Designation, in the case of the death or disability of Series D Preferred holder, the Series D Preferred is not redeemable without the prior express written consent of the holders of the majority of the voting power of all then outstanding shares of such Series D Preferred. In the event any shares of Series D Preferred are redeemed pursuant, the shares redeemed will automatically be canceled and returned to the status of authorized but uni ssued shares of preferred stock,

 

each share of Series D Preferred entitles the holder to four hundred ( 400 ) votes.  With respect to such vote, the holder is entitled to notice of any stockholders' meeting in accordance with the bylaws of the Company, and is entitled to vote, together as a single class with holders of common stock and any other series of preferred stock then outstanding, with respect to any question or matter upon which holders of common stock have the right to vote.  The Series D Preferred will also entitle the holders to vote the shares as a separate class as set forth herein and as required by law. In the event of any stock split, stock dividend or reclassification of the Corporation's common stock, the number of votes which attach to each share of Series D Preferred shall be adjusted in the same proportion as any adjustment to the number of outstanding shares of common stock. The shares of Series D Preferred present at a meeting of the Company’s stockholders shall vote in the same percentage as all voting shares voted for each director at the Company’s stockholder meeting in connection with the election or removal of directors to or from the Corporation’s Board of Directors,

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

 

in the event of the liquidation, dissolution or winding up of the affairs of the Corporation, whether voluntary or involuntary, the holders of shares of the Series D Preferred then outstanding are entitled to receive before holders of shares of common stock receive any amounts, out of the remaining assets of the Corporation available for distribution to its stockholders, an amount equal to $0.001 pe r share,

 

so long as any shares of Series D Preferred are outstanding, the Company cannot without first obtaining the written approval of the holders of at least a majority of the voting power of the then outstanding shares of such Series D Preferred Stock (i) alter or change the rights, preferences or privileges of the Series D Preferred, or (ii) increase or decrease the total number of authorized sha res of Series D Preferred Stock,

 

the holders of the Series D Preferred are not entitled to rights to subscribe for, purchase or receive any part of any new or additional shares of any class, whether now or hereinafter authorized, or of bonds or debentures, or other evidences of indebtedness convertible into or exchangeable for shares of any class,

 

the Company has a thirty ( 30 ) day “right of first refusal” in which to match the terms and conditions set forth in any bona fide offer received by holders of the Series D Preferred Stock.   The Company must purchase all of those shares of Series D Preferred offered by the holder of the Series D Preferred Stock, and

 

the holders of Series D Preferred cannot, directly or indirectly, transfer any shares of Series D Preferred.   Any such purported transfer shall be of no force or effect and shall not be recognized by the Company.

 

  Warrants Issued for Services and in Capital Transactions

 

The following tables summarize all warrants issued as part of debt transactions for the year s ended December 31, 2017 and December 31, 2016, and the related changes during these years.

 

December 31, 2017

   

December 31, 2017

 

Warrants outstanding

   

Warrants exercisable

 
           

Weighted average

   

Weighted

           

Weighted

 

Range of exercise price

 

Number

outstanding

   

remaining

contractual life

   

average

exercise price

   

Number exercisable

   

average

exercise price

 

$0.25

$0.60     27,020,000       1.84     $ 0.42       27,020,000     $ 0.42  

 

December 31, 2016

   

December 31, 2016

 

Warrants outstanding

   

Warrants exercisable

 
           

Weighted average

   

Weighted

           

Weighted

 

Range of exercise price

 

Number

outstanding

   

remaining

contractual life

   

average

exercise price

   

Number exercisable

   

average

exercise price

 

$0.25

$0.60     27,860,000       2.71     $ 0.42       27,860,000     $ 0.42  

 

Warrants

       

Balance at December 31, 2015

    22,900,000  

Issued

    4,970,000  

Exercised

    -0-  

Expired/forfeited

    (10,000 )

Balance at December 31, 2016

    27,860,000  

Issued

    -0-  

Exercised

    -0-  

Expired/forfeited

    (840,000 )

Balance at December 31, 2017

    27,020,000  

Warrants exercisable at December 31, 2017

    27,020,000  
         

Weighted average fair value of warrants granted during 2017

    n/a  

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

Other Comprehensive (Loss)

 

Due to the availability of net operating losses and related deferred tax valuations, there is no tax effect associated with any component of other comprehensive (loss).   The following table lists the beginning balance, yearly activity and ending balance of the components of accumulated other comprehensive (loss).

 

   

Foreign currency

translation

   

Accumulated other

comprehensive (loss)

 

Balance at December 31, 2015

  $ (366,355 )   $ (366,355 )

2016 Activity

    (44,150 )     (44,150 )

Balance at December 31, 2016

    (410,505 )     (410,505 )

2017 Activity

    13,268       13,268  

Balance at December 31, 2017

  $ (397,237 )   $ (397,237 )

 

 

 

  NOTE 1 3 :               EMPLOYEE EQUITY INCENTIVE PLANS

 

Stock Option Plan s

 

Description of 2016 Equity Incentive Plan

 

In 2016, the Company ’s Board of Directors and stockholders approved the OmniComm Systems, Inc. 2016 Equity Incentive Plan (the “2016 Plan”). The 2016 Plan provides for granting Incentive Stock Options, Nonqualified Stock Options, Stock Appreciation Rights, Restricted Stock Awards, Phantom Stock Unit Awards and Performance Share Units. The 2016 Plan provides for the issuance of up to 10,000,000 shares of our common stock for issuance upon awards granted under the 2016 Plan. In addition, the number of shares of common stock available for issuance under the 2016 Plan shall automatically increase on January 1st of each year for a period of nine ( 9 ) years commencing on January 1, 2017 and ending on (and including) January 1, 2025, in an amount equal to five percent ( 5% ) of the total number of shares authorized under the 2016 Plan. Unless earlier terminated by the Board, the 2016 Plan shall terminate on June 29, 2026. As of December 31, 2017 10,500,000 shares were authorized under the 2016 Plan.

 

The maximum term for any option grant under the 2016 Plan is ten years from the date of the grant; however, options granted under the 2016 Plan will generally expire five years from the date of grant. Options granted under the 2016 Plan generally vest either upon grant or in two installments and may be conditioned on performance. Performance based options may be conditioned upon the attainment of revenue, EDITDA or other financial or performance goals of the Company. The first vesting, which is equal to 50% of the granted stock options, usually occurs upon completion of one full year of employment from the date of grant and the second vesting usually occurs on the second anniversary of the date of grant. The vesting period typically begins on the date of hire for new employees and on the date of grant for existing employees. The restrictions on restricted shares granted under the 2016 Plan generally lapse in three equal annual installments on the anniversary of the date of grant.   Any unvested stock options or restricted shares with restrictions that have not lapsed that are granted under the 2016 Plan are forfeited and expire upon termination of employment.

 

As of December 31, 2017, there were 4,900,000 outstanding options and - 0 - restricted stock shares that have been granted under the 2016 Plan. At December 31, 2017, there were 5,600,000 shares available for grant as options or other forms of share-based compensation under the 2016 Plan.

 

Description of 2009 Equity Incentive Plan

 

In 2009, the Company ’s Board of Directors and stockholders approved the 2009 Equity Incentive Plan of OmniComm Systems, Inc. (the “2009 Plan”).  The 2009 Plan provided for granting Incentive Stock Options, Nonqualified Stock Options, Stock Appreciation Rights, Restricted Stock Awards, Phantom Stock Unit Awards and Performance Share Units.  Pursuant to the 2009 Plan, 7,500,000 shares of the Company’s common stock were authorized for issuance.

 

The maximum term for any op tion grant under the 2009 Plan was ten years from the date of the grant; however, options granted under the 2009 Plan generally expired five years from the date of grant for most employees, officers and directors of the Company.  Options granted under the 2009 Plan generally vested either upon grant or in two installments.  The first vesting, which is equal to 50% of the granted stock options, occurred upon completion of one full year of employment from the date of grant and the second vesting occurred on the second anniversary of the employee’s employment.  The vesting period typically began on the date of hire for new employees and on the date of grant for existing employees. The restrictions on restricted shares granted under the 2009  Plan generally lapsed in three equal annual installments on the anniversary of the date of grant.   Any unvested stock options or restricted shares with restrictions that had  not lapsed that were granted under the 2009  Plan were forfeited and expired upon termination of employment. The 2009 Plan was terminated upon the approval of the 2016 Plan. No further grants will be made under the 2009 Plan.

 

As of December 31, 2017, there were 375,000 outstanding options and 3,876,662 restricted stock shares that have been granted under the 2009 Plan.  At December 31, 2017, there were - 0 - shares available for grant as options or other forms of share-based compensation under the 2009 Plan.

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

The following table summarizes the stock option activity for the Company ’s equity incentive plans:

 

   

Number of

options

   

Weighted average

exercise price
(per share)

   

Weighted average

remaining

contractual term
(in years)

   

Aggregate

intrinsic value

 
                                 

Outstanding at December 31, 2015

    2,002,500     $ 0.14       1.40     $ 198,990  

Granted

    450,000       0.20                  

Exercised

    (1,120,000 )     0.12                  

Forfeited/cancelled/expired

    (107,500 )     0.29                  
                                 

Outstanding at December 31, 2016

    1,225,000       0.17       2.62     $ 83,425  

Granted

    4,650,000       0.26                  

Exercised

    (300,000 )     0.13                  

Forfeited/cancelled/expired

    (300,000 )     0.14                  
                                 

Outstanding at December 31, 2017

    5,275,000     $ 0.26       4.09     $ 130,475  
                                 
                                 

Vested and exercisable at December 31, 2017

    400,000     $ 0.19       1.42     $ 32,638  

 

The aggregate intrinsic value in the table above represents the total intrinsic value (the difference between the Company ’s closing stock price at fiscal year-end and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on December 31, 2017.

 

The total number of shares vested and the fair value of shares vested for the years ended December 31, 2017 and December 31, 2016, respectively, was:

 

Fair value of options vesting  for the year ended

 

Number of options

vested

   

Fair value of

options vested

 

December 31, 2017

    62,500     $ 12,742  

December 31, 2016

    162,500     $ 33,622  

 

 

Cash received from stock option exercises for the year ended December 31, 2017 was $35,250 and $129,500 for the year ended  December 31, 2016.  Due to the Company’s net loss position, no income tax benefit has been realized during the years ended December 31, 2017 and December 31, 2016.

 

The following table summarizes information concerning options outstanding at December 31, 2017:

 

Awards breakdown by price range at December 31, 2017

 
         

Outstanding

   

Vested

 

Strike price range ($)

   

Outstanding

stock options

   

Weighted

average

remaining

contractual life

   

Weighted

average

outstanding

strike price

   

Vested stock

options

   

Weighted

average

remaining

vested

contractual life

   

Weighted

average vested

strike price

 
0.00 to 0.20       300,000       1.93     $ 0.18       250,000       1.48     $ 0.17  
0.21 to 0.30       4,250,000       4.12       0.25       150,000       1.30       0.22  
0.31 to 0.50       725,000       4.82       0.34       -0-       0.00       0.00  
0.00 to 0.50       5,275,000       4.09     $ 0.26       400,000       1.42     $ 0.19  

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

The following table summarizes information concerning options outstanding at December 31, 2016:

 

Awards breakdown by price range at December 31, 2016

 
         

Outstanding

   

Vested

 

Strike price range ($)

   

Outstanding

stock options

   

Weighted

average

remaining

contractual life

   

Weighted

average

outstanding

strike price

   

Vested stock

options

   

Weighted

average

remaining

vested

contractual life

   

Weighted

average vested

strike price

 
0.00 to 0.20       850,000       2.15     $ 0.15       625,000       1.32     $ 0.14  
0.21 to 0.30       375,000       3.70       0.23       112,500       1.67       0.21  
0.31 to 0.50       -0-       0.00       0.00       -0-       0.00       0.00  
0.00 to 0.50       1,225,000       2.62     $ 0.17       737,500       1.38     $ 0.15  

 

The weighted average fair value (per share) of options granted during the year ended December 31, 2017 was $0.21 and $0.19 for the year ended December 31, 2016 using the Black Scholes option-pricing model.

 

Basis for Fair Value Estimate of Share-Based Payments

 

Based on analysis of its historical volatility, the Company expects that the future volatility of its share price is likely to be similar to the historical volatility the Company experienced since the Company ’s commercialization activities were initiated during the second half of 2000. The Company used a volatility calculation utilizing the Company’s own historical volatility to estimate its future volatility for purposes of valuing the share-based payments granted during fiscal 2017 and 2016. Actual volatility, and future changes in estimated volatility, may differ substantially from the Company’s current estimates.

 

The Company utilizes the historical data available regarding employee and director exercise activity to calculate an expected life of the options. The table below presents the weighted average expected life in years of options granted under the Plan as described above. The risk-free rate of the stock options is based on the U.S. Treasury yield curve in effect at the time of grant, which corresponds with the expected term of the option granted.

 

The fair value of share-based payments was estimated using the Black Scholes option pricing model with the following assumptions for grants made during the periods indicated.    

 

   

For the year ended

 

Stock option assumptions

 

December 31, 2017

   

December 31, 2016

 

Risk-free interest rate

    1.81%       1.45%  

Expected dividend yield

    0.0%       0.0%  

Expected volatility

    127.1%       155.5%  

Expected life of options (in years)

    5       5  

 

The following table summarizes weighted average grant date fair value for the Company incentive stock plans:

 

   

Weighted average grant date fair value

 
   

for the year ended December 31,

 
   

2017

   

2016

 

Stock options granted during the period

  $ 0.21     $ 0.19  
                 

Stock options vested during the period

  $ 0.20     $ 0.21  
                 

Stock options forfeited during the period

  $ 0.13     $ 0.28  

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

A summary of the status of the Company ’s non-vested shares underlying stock options as of December 31, 2017, and changes during the year ended December 31, 2017 is as follows:

 

   

Shares underlying stock

options

   

Weighted average grant

date fair value

 

Nonvested shares at January 1, 2017

    487,500     $ 0.19  
                 

Nonvested shares at December 31, 2017

    4,875,000     $ 0.21  

 

 

As of December 31, 2017, approximately $656,978 of total unrecognized compensation cost related to unvested stock options is expected to be recognized over a weighted-average period of 2.08 years.

 

 

NOTE 1 4 :               INCOME TAXES

 

A reconciliation of income tax expense and the amount computed by applying the statutory federal income tax rate to the income before provision for income taxes is as follows :

 

   

December 31, 2017

   

December 31, 2016

 

Federal statutory rate applied to income/(loss) before income taxes

  $ 1,117,014     $ 38,740  

Increase/(decrease) in income taxes results from:

               

Current tax expense/(benefit)

    1,194       1,069  

Nondeductible expenses

    (44,845 )     1,078,519  

Change in deferred assets

    (35,423 )     41,019  

Change in valuation allowance

    (1,036,746 )     (1,158,278 )
                 

Income tax expense/(benefit)

  $ 1,194     $ 1,069  

 

The components of income tax expense /(benefit) for the year ended:

 

   

December 31, 2017

   

December 31, 2016

 

Current tax expense/(benefit):

  $ 1,194     $ 1,069  

Deferred tax expense/(benefit):

               

Bad debt allowance

    11,226       (23,699 )

Operating loss carryforward

    1,060,942       1,140,957  

Amortization of intangibles

    5,482       5,482  

Patent litigation settlement

    (40,904 )     35,538  
      1,037,940       1,159,347  

Valuation allowance

    (1,036,746 )     (1,158,278 )
                 

Total tax expense/(benefit)

  $ 1,194     $ 1,069  

 

Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of our deferred tax assets and liabilities are as follows:

 

   

December 31, 2017

   

December 31, 2016

 

Amortization of intangibles

  $ 261,771     $ 267,253  

Bad debt allowance

    55,436       66,662  

Patent litigation liability accrual

    169,709       128,804  
Impact of the Tax Cuts and Jobs Act     (1,699,440 )     -0-  

Operating loss carryforwards

    17,973,631       19,034,573  

Gross deferred tax assets

    16,761,107       19,497,292  

Valuation allowance

    (16,761,107 )     (19,497,292 )
                 

Net deferred tax liability/(asset)

  $ -0-     $ -0-  

 

 

OMNICOMM SYSTEMS, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND DECEMBER 31, 2016

 

The Company has net operating loss carry forwards (NOL) for income tax purposes of approximately $ 32,543,685.  This loss is allowed to be offset against future income until the year 2037  when the NOL’s will expire. Other timing differences relate to depreciation and amortization for the stock acquisition of Education Navigator in 1998.  The tax benefits relating to all timing differences have been fully reserved for in the valuation allowance account due to the substantial losses incurred through December 31, 2017.  The change in the valuation allowance for the year ended December 31, 2017 was a decrease of $2,736,185. The Company's tax returns for the prior three years remain subject to examination by major tax jurisdictions.

 

On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act ("Tax Act"). The Tax Act establishes new tax laws that affect 2018 and future years, including a reduction in the U.S. federal corporate tax rate to 21 percent effective January 1, 2018. For certain deferred tax assets and deferred tax liabilities, we have recorded a provisional change of $1,699,440, with a corresponding net adjustment to valuation allowance of $1,699,440  as of December 31, 2017.

 

 

NOTE 1 5 :               SUBSEQUENT EVENTS

 

 

Subsequent to December 31, 2017 the Company drew  $1,750,000 on its Line of Credit.

 

Subsequent to December 31, 2017 the Company acquired certain assets and liabilities from Algorithm, Inc. for the price of $500,000 in cash and 1,666,667 restricted common shares.

 

Subsequent to December 31, 2017 the Company cancelled the performance based stock option grants to the executive officers and external directors that had been granted in 2017 as the performance criteria had not been met.

 

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