What changed in this filing

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Item 1. Business

2022-02-28 compared with 2021-03-08 · 184 added, 185 removed, 22 unchanged (94% of the section changed)

OptimizeRx is a digital health company

that provides communications solutions for life science companies, physicians and patients.

Connecting over half of healthcare

providers in the U.S.

and millions of patients through a proprietary network, the OptimizeRx digital health platform helps patients

afford and stay on medications.

The platform unlocks new patient and physician touchpoints for life science companies along the

patient journey, from point-of-care, to retail pharmacy, through mobile patient engagement.

OptimizeRx is a digital health technology company

enabling care-focused engagement between life sciences organizations, healthcare providers, and patients at critical junctures throughout

the patient care journey.

Connecting over 60% of U.S.

healthcare providers and millions of their patients through an intelligent technology

platform embedded within a proprietary point-of-care network, OptimizeRx helps patients start and stay on their medications.

We are a Nevada corporation organized in September

We conduct our operations through our wholly-owned subsidiaries, OptimizeRx Corporation, a Michigan corporation, CareSpeak

Communications, Inc., a New Jersey corporation, CareSpeak Communications, D.O.O, a controlled foreign corporation incorporated in Croatia,

RMDY Health, Inc.

a Delaware corporation, and Cyberdiet, a controlled foreign corporation incorporated in Israel.

2021 Company Highlights

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Our net revenue increased to a record $20.3 million in Q4 2021, up 24% over Q4 2020.

We expanded our sales leadership team by a adding a point of care expert and established a strong

base for growth in 2021.

We launched our TelaRep solution in April and in December, it was recognized as one of the most

innovative products for life sciences in 2020 by PM 360 magazine.

Sales and Marketing Update

Our sales team continues to expand our

business with existing and new clients communicating the increased value of our enterprise platform approach.

We are focused

on increasing the depth and breadth of our business across existing client product portfolios by maximizing the utilization of

We are expanding our business by providing new solutions and obtaining new clients.

Our team is also working

on converting current clients from individual solutions to enterprise platform deals with access to our full set of solutions across

These enterprise deals enable us to increase our revenue per customer, and give us a more predictable and consistent

revenue stream.

While our expenditures were down in 2020

due to the global pandemic, we have continued to ramp up our marketing efforts by focusing more heavily on strategic content with

thought leadership in the media and at events, as well as tailoring our solution marketing with an account-based approach.

efforts are focused on cementing our image as a strategic partner with our buyers, so we have expanded our panel of thought leadership

voices to include more of our leadership team.

They are actively participating as speakers and panelists at industry events, and

we have significantly increased our footprint within earned industry media.

Additionally, we hosted a series of webinars featuring

industry leaders in 2020 to foster collaboration, and we introduced the first annual Innovate4Outcomes event, bringing together

thought leaders from across the healthcare industry to collaborate on solutions to some of the toughest challenges facing life

sciences and providers.

We expanded our attendance and participation

at investor conferences in 2020, most on a virtual basis.

We have built marketing strategy momentum in 2020 with increased industry

visibility that we expect to expand in 2021.

Operational Update

In 2020, we continued to expand our existing

network and physician utilization of our partner networks.

We continue to work individually with our partners to improve point-of-care

workflow, increase overall revenue derived from each channel and increase coupon utilization by providers who have access.

also focused on increasing the number of physicians who have access to our service offerings.

In addition to revenue growth provided

by new pharma brands and network partners, we believe there is significant revenue growth potential within existing brands by better

utilizing our existing partner networks and expanding our available solutions.

We also signed agreements with partners

that give us access to provide messages directly to consumers.

Technology Update

To support our growth and to further improve

the efficiency of our systems, we have moved our core platforms to Amazon Web Services.

As a result of our acquisitions in 2018

and 2019, we now have tech teams based in both Croatia and Israel, in addition to our core team in the U.S., to help develop further

applications throughout the organization.

Achieved positive cashflow from operations of $0.7 million for the year ended December 31, 2021.

We generated net income of $0.4 million in 2021 as compared to a loss of $2.2 million in 2020.

Completed the integration work for our previous acquisitions and paid the last earnout payment related

to the acquisitions.

Raised an additional $70.7 million in capital in a public offering in February 2021.

Enhanced our leadership team by adding Edward Stelmakh as Chief Operating Officer and Chief Financial

Expanded our pipeline for our new Real-World Evidence (“RWE”) messaging solution that we launched

in the second quarter of 2021.

We announced the launch of our new Therapy

Initiation Workflow , which enables pharmaceutical manufacturers to execute market access strategies, and particularly supports the

fast-growing area of specialty medications.

We launched multiple Evidence-Based Physician

Engagement programs and in December, the solution was recognized as one of the most innovative products for life sciences by PM 360 magazine.

We were listed as one of the Americas’

Fastest Growing Companies by Deloitte and the Financial Times

We were added to the S&P SmallCap 600 Index

in October 2021.

Principal Solutions and Applications

Our principal solutions and applications

can be summarized as follows:

Financial Messaging –

Our integrated financial messaging platform is a revolutionary virtual “Patient Support Center”

that allows doctors and staff to access a universe of sample vouchers, co-pay coupons and other patient support options through their EMR and/or e-Prescribe systems.

Our principal solutions and applications can be

summarized as follows:

Financial Messaging – Our integrated financial messaging platform is a revolutionary virtual “Patient Support Center” that allows doctors and staff to access a universe of sample vouchers, co-pay coupons and other patient support options through their EMR and/or e-Prescribe systems.

It allows them to search, print or electronically dispense directly to patients and a national network of pharmacies.

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While samples are still valuable, our solution addresses the fact that many healthcare systems and doctors are looking for an easier, more effective way to increase affordable access and adherence to their prescribed branded medications.

Brand and Therapeutic Support Messaging –

Our brand messaging services include a variety of brand awareness and therapeutic support messaging services that can be tailored to meet the needs of a brand.

Brand and Therapeutic Support Messaging – Our brand messaging services include a variety of brand awareness and therapeutic support messaging services that can be tailored to meet the needs of a brand.

These messages can include brand awareness messages, reminder ads, therapeutic support messages and unbranded messages that can be targeted by specialty, diagnostic code and other criteria.

Brand messaging is highly complementary to our core financial messaging solution.

Historically, we have sold brand messaging based on specific solutions offered by our Electronic Health Record (“EHR”) partners, but we have developed our own proprietary banner messaging system, rolled this solution out in 2017, and expanded it since then.

We also developed our own therapeutic support messaging system and launched it with our first partner in late 2018.

We believe brand messaging represents a significant growth opportunity for us.

Brand Support –

Our brand support is focused on educating and working with pharmaceutical manufacturers on identifying, formulating, and implementing new eRx media strategies for promoting their solutions.

Brand Support – Our brand support is focused on educating and working with pharmaceutical manufacturers on identifying, formulating, and implementing new eRx media strategies for promoting their solutions.

Our services include:

1) Drug File Integration - a service designed to better insure that manufacturers’

drugs are present in every ePrescribing platform available;

2) Sales Force Training –

a service to educate the extended field sales force on this new integrated solution and what to look for within their client base to insure maximum exposure of their brands;

and 3) Strategy Development –

a service that assists pharmaceutical manufacturers in identifying and building a competitive strategy to take advantage of this new digital frontier.

1) Drug File Integration - a service designed to better insure that manufacturers’ drugs are present in every ePrescribing platform available;

2) Sales Force Training – a service to educate the extended field sales force on this new integrated solution and what to look for within their client base to insure maximum exposure of their brands;

and 3) Strategy Development – a service that assists pharmaceutical manufacturers in identifying and building a competitive strategy to take advantage of this new digital frontier.

Currently, this activity results in less than 10% of our revenue, but represents a significant growth opportunity for us.

Patient Engagement –

Our patient engagement activities arose out of our acquisition of CareSpeak Communications in October 2018, followed by our acquisition of RMDY Health in 2019.

Our technology solution provides digital messaging services through our cloud based Mobile Health Messenger (“MHM”) Platform.

Patient Engagement – Our patient engagement activities arose out of our acquisition of CareSpeak Communications in October 2018, followed by our acquisition of RMDY Health in 2019.

Our technology solution provides digital messaging services through our cloud based Mobile Health Messenger (“MHM”) Platform.

We provide interactive health messaging for improved medication adherence and care coordination.

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We enable this functionality for our customers, with our solutions delivering a variety of intervention mechanisms that help treat chronic conditions, such as diabetes and heart disease.

Our core platform competes in the highly

competitive pharmaceutical and life sciences digital marketing industry that is dominated by large well-known companies with established

Evidence-Based Physician Engagement – Our evidence-based physician engagement solution uses predictive analytics via machine learning methods applied to real-world data (RWD) to assist healthcare providers (HCPs) in identifying patients who may be qualified for specific therapies, raise awareness of patient access pathways, and identify early indicators of non-adherence among patient populations.

This real-world evidence (RWE) solution translates into better support for providers as they look to make the best treatment decisions for their patients.

This solution has a “patient-first” focus, helping manufacturers identify which HCPs to engage by first identifying if they have patients in need of support, based on where they are in their care journey and disease state.

This needs assessment is completed in real time using the AI technology on our Therapy Initiation and Persistence Platform , reducing delay in support delivery caused by traditional applications of RWD in engagement activities.

Therapy Initiation Workflow – the therapy initiation workflow is a digital solution focused on accelerating patient access to treatments where time-consuming medical documentation is required of HCPs prior to pharmacies dispensing prescribed drugs.

The new platform enhancement particularly supports the fast-growing area of specialty medications.

In-line with the major digitization paradigm shift across healthcare, this technology enhancement allows life sciences companies to simplify therapy initiation by presenting HCPs with a fully electronic option synchronizing enrollment, benefits verification, prior authorization, and patient support onboarding.

Sales and Marketing Update

Our sales team continues to expand our business

with existing and new clients, strategically focused on the digital connection of care between the pharmaceutical industry, physicians,

and patients.

We continue driving awareness of the increased value of our enterprise platform approach, expanding our share of customer

wallet in reflection of the life sciences budget shift to digital solutions.

We have increased the depth and breadth of our business across

existing client product portfolios by maximizing the utilization of our network.

We are expanding our business by making significant

enhancements to our platform and network to digitize pharmaceutical access solutions in support of major industry paradigm shift towards

improving patient care and adherence through technology.

In 2021 we announced the launch of our new Therapy Initiation Workflow ,

a digital solution focused on accelerating patient access to treatments where time-consuming medical documentation is required of HCPs

prior to pharmacies dispensing prescribed drugs.

The new platform enhancement particularly supports the fast-growing area of specialty

Our team continues to work on converting current clients from individual solutions to enterprise platform deals with access

to our full set of solutions across our network.

These enterprise deals enable us to increase our revenue per customer and give us a more

predictable and consistent revenue stream.

In 2021, we delivered on our marketing strategy

to focus more heavily on strategic content and expansion beyond specific product marketing efforts with a 10x increase in engagement with

our content, resulting in higher brand visibility through organic, non-paid channels.

Our efforts remain focused on cementing our image

as a strategic partner with our buyers, and we have completed a positioning expansion effort to better capture the value of our platform

with our buyers in light of the innovations we have deployed over the last two years.

Additionally, we hosted a series of webinars featuring

industry leaders in 2021 to foster collaboration, and we hosted our second annual Innovate4Outcomes event, partnering with patient advocacy

groups to brainstorm actionable solutions to address standards of care and equal access to treatment for patients.

We have continued building marketing strategy

momentum in 2021 with increased industry visibility that we expect to expand in 2022.

Operational Update

In 2021, we continued expansion of our network,

driving a broad mix of HCP specialties in alignment with our commercial customer therapeutic portfolios.

The introduction of Real-World

Evidence and expansion into omni-channel engagement brought engagement opportunities beyond the point of prescribe, enabling access to

life saving therapies.

Leveraging AI, we engage providers and patients with the right insight at precisely the right time, helping

to drive improved outcomes.

Technology Update

To support our growth and to further improve the

efficiency of our systems, we have moved our core platforms to Amazon Web Services.

As a result of our acquisitions in 2018 and 2019,

we now have tech teams based in both Croatia and Israel, in addition to our core team in the U.S., to help develop further applications

throughout the organization.

All application code, libraires, and 3 rd

party services are maintained at high levels, with an ongoing regimen of patches and upgrades and version synchronization to ensure both

forward looking and reverse compatibility.

Systems enhancements in 2021 included upgrades

and full documentation of processes and procedures and security implementation in support of full Enterprise HITRUST Certification in

2022, as well as for ongoing Sarbanes Oxley, HIPAA, customer assessments and other needs.

All systems are fully scalable, automatically

based on various metrics, thresholds, and are live-live in multiple redundant geographically disparate data centers.

Applications introduced are modular and flexible

allowing enhancements and new solutions to flow through the system which results in rapid implementation by our partners that typically

only takes a few weeks to one quarter.

Our platforms face competition from numerous other

companies, both in attracting users and in generating revenue from advertisers and sponsors.

We compete for users with online services

and websites that provide savings on medications and healthcare products, including both commercial sites and not-for-profit sites.

compete for advertisers and sponsors with health-related web sites, general purpose consumer web sites that offer specialized health sub-channels,

other high-traffic web sites that include both healthcare-related and non-healthcare-related content and services, search engines that

provide specialized health searches, and advertising networks that aggregate traffic from multiple sites.

Our messaging platform competes broadly in the

highly competitive pharmaceutical and life sciences digital marketing industry that is dominated by large well-known companies with established

names, solid market niches, wide arrays of product offerings and marketing networks.

Our messaging offerings compete for pharmaceutical

budgets with a variety of other forms of advertising and promotion.

We have a growing list of potential partners

whom either have content that they want to deliver through our distribution engine and network, or have complementary technology

and want to integrate our solution as a channel partner and thereby increase their reach to clinicians.

Many of our competitors have greater financial, technical,

product development, marketing and other resources than we do.

These organizations may be better known than we are and have more customers

or users than we do.

Our messaging offerings compete for pharmaceutical budgets with a variety of other forms of advertising and promotion.

Our platform is unique in its ability to reach prescribers directly in their workflow through their EHR.

The primary direct competitor

in our space of the market is ConnectiveRx.

However, we believe our breadth of brands offered, extensive list of pharmaceutical

clients, and the vast reach of our network give us a substantial advantage and allow us to achieve a dominant position in the marketplace.

in our financial messaging solution is ConnectiveRx.

We generally compete on the basis of several factors, including size of our network,

quality of our service, our ability to target specific customer needs, and to a lesser extent, price.

We believe we compete favorably

on these metrics.

For more information on risks relating to our competition, see Item 1A.

Risk Factors.

Intellectual Property

In 2012, we were awarded a patent for our

innovative solution (US Patent No.

This award was a result of our extensive research and development efforts.

claims cover our ability to electronically process, display and distribute eligible prescription savings on the medications and

therapies healthcare providers wish to prescribe for their patients.

As part of our acquisition of CareSpeak Communications, we

also acquired (US Patent No.

7,956,727) related to methods and systems for medication management.

We also have other patent applications

submitted in various stages of review.

We use a nationally ranked intellectual

property law firm to further expand and protect our intellectual property.

We believe our current and expanding IP will allow us

to continue being the leader in this rapidly growing space.

We stand ready to prepare additional filings, as necessary, to protect

our intellectual property on any forthcoming solutions that will further assist and support physicians, pharmacists and patients.

OPTIMIZERx, CareSpeak, RMDY Wellness Layers,

Diet Watch, and SampleMD are our licensed trademarks.

We own a number of patents important to our business,

and we expect to continue to file patent applications to protect our research and development investments in new products.

As of December 31,

2021 we held 3 patents and several pending patent applications, including foreign counterpart patents and foreign applications.

United States, patents may last 20 years from the date of the patent’s filing, depending upon term adjustments made by the patent

In addition, we hold numerous trademarks in the United States and other countries.

We also have licenses to intellectual property

for the use and sale of certain of our solutions.

OPTIMIZERx, TELAREP, CareSpeak, RMDY Wellness

Layers, Diet Watch, and SampleMD are our licensed trademarks.

We obtain other intellectual property rights and/or

licenses used in connection with our business when practical and appropriate.

Historically, we have done so both organically, through

commercial relationships and in connection with acquisitions.

Government Regulation

Fraud and Abuse Laws

Anti-Kickback Statutes

The federal healthcare program Anti-Kickback Statute prohibits

persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in exchange

for or to induce either the referral of an individual for, or the furnishing, arranging for or recommending a good or service for

which payment may be made in whole or part under a federal healthcare program such as Medicare or Medicaid.

The definition of remuneration

has been broadly interpreted to include anything of value, including for example gifts, discounts, the furnishing of supplies or

equipment, credit arrangements, payments of cash and waivers of payments.

Several courts have interpreted the statute’s intent

requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals or otherwise generate

business involving goods or services reimbursed in whole or in part under federal healthcare programs, the statute has been violated.

The law contains a few statutory exceptions, including payments to bona fide employees, certain discounts and certain payments

to group purchasing organizations.

Violations can result in significant penalties, imprisonment and exclusion from Medicare, Medicaid

and other federal healthcare programs.

Exclusion of a manufacturer would preclude any federal healthcare program from paying for

its products.

In addition, kickback arrangements can provide the basis for an action under the Federal False Claims Act, which

is discussed in more detail below.

The Anti-Kickback Statute is broad and potentially prohibits many arrangements and practices

that are lawful in businesses outside of the healthcare industry.

Recognizing that the Anti-Kickback Statute is broad and may technically

prohibit many innocuous or beneficial arrangements, the Office of Inspector General of Health and Human Services, or OIG, issued

a series of regulations, known as the safe harbors, beginning in July 1991.

These safe harbors set forth provisions that, if all

the applicable requirements are met, will assure healthcare providers and other parties that they will not be prosecuted under

the Anti-Kickback Statute.

The failure of a transaction or arrangement to fit precisely within one or more safe harbors does not

necessarily mean that it is illegal or that prosecution will be pursued.

However, conduct and business arrangements that do not

fully satisfy each applicable safe harbor may result in increased scrutiny by government enforcement authorities such as the OIG.

Arrangements that implicate the Anti-Kickback Law, and that do not fall within a safe harbor, are analyzed by the OIG on a case-by-case

Government officials have focused recent enforcement efforts on, among other things, the sales and marketing activities

of healthcare companies, and recently have brought cases against individuals or entities with personnel who allegedly offered unlawful

inducements to potential or existing customers in an attempt to procure their business.

Settlements of these cases by healthcare

companies have involved significant fines and/or penalties and in some instances criminal pleas.

In addition to the Federal Anti-Kickback

Statute, many states have their own kickback laws.

Often, these laws closely follow the language of the federal law, although they

do not always have the same exceptions or safe harbors.

In some states, these anti-kickback laws apply with respect to all payors,

including commercial health insurance companies.

False Claims Laws

Federal false claims laws prohibit any

person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government or knowingly

making, or causing to be made, a false statement to get a false claim paid.

Manufacturers can be held liable under false claims

laws, even if they do not submit claims to the government, if they are found to have caused submission of false claims.

Civil False Claims Act also includes whistle blower provisions that allow private citizens to bring suit against an entity or individual

on behalf of the United States and to recover a portion of any monetary recovery.

Many of the recent highly publicized settlements

in the healthcare industry related to sales and marketing practices have been cases brought under the False Claims Act.

of states also have statutes or regulations similar to the federal false claims laws, which apply to items and services reimbursed

under Medicaid and other state programs, or, in several states, apply regardless of the payor.

Sanctions under these federal and

state laws may include civil monetary penalties, exclusion of a manufacturer’s products from reimbursement under government

programs, criminal fines and imprisonment.

Privacy and Security

The Health Insurance Portability and Accountability

Act of 1996, or HIPAA, and the rules promulgated there under require certain entities, referred to as covered entities, to comply

with established standards, including standards regarding the privacy and security of protected health information, or PHI.

further requires that covered entities enter into agreements meeting certain regulatory requirements with their business associates,

as such term is defined by HIPAA, which, among other things, obligate the business associates to safeguard the covered entity’s

PHI against improper use and disclosure.

While not directly regulated by HIPAA, our customers or distributors might face significant

contractual liability pursuant to such an agreement if the business associate breaches the agreement or causes the covered entity

to fail to comply with HIPAA.

It is possible that HIPPA compliance could become a substantial regulatory burden and

expense to our operations, although we do not believe that this will occur as a general website publisher.

As of December 31, 2020, we had 57 full-time

employees in the U.S, as well as 14 full-time international employees.

None of our employees are represented by a labor union with

respect to their employment with us.

We have not experienced any work stoppages, and we consider our relations with our employees

We conduct our operations through our wholly-owned

subsidiaries, OptimizeRx Corporation, a Michigan corporation, CareSpeak Communications, Inc., a New Jersey corporation, CareSpeak

Communications, D.O.O, a controlled foreign corporation incorporated in Croatia, RMDY Health, Inc.

a Delaware corporation, and

Cyberdiet, a controlled foreign corporation incorporated in Israel.

Recent developments

In March 2021, our Board of Directors amended

the 2013 Incentive Plan to increase the number of shares authorized under the Plan to 6,000.000 shares.

The healthcare industry and, in particular, our

customers and partners are subject to applicable U.S.

federal, state and local laws and regulations, including those governing fraud,

abuse, privacy and security.

Many of these laws and regulations are complicated and how they might apply to us, our customers, our partners,

or the specific services and relationships we have with our customers and partners are not always well-defined.

Our failure, or perceived

failure, to accurately apply, or comply with, these laws and regulations could subject us to significant fines and liability, result in

reputational harm, and adversely affect our business.

Risk Factors for more information on the impact of Government Regulations

on OptimizeRx.

As of December 31, 2021, we had 82 full-time employees

in the U.S, as well as 15 full-time international employees, and no part-time employees.

None of our employees are represented by a labor

union or collective bargaining agreement with respect to their employment with us.

The majority of our employees work remotely and are

geographically distributed across the United States, Israel and Croatia.

We supplement our workforce with contractors in the United States

and internationally on an as needed basis.

We consider our relationship with our employees to be good and have not experienced any work

We are dedicated

to maintaining an environment where everyone feels valued, and we celebrate both the differences and similarities among our people.

also believe that diversity in all areas, including cultural background, experience and thought, is essential in making our Company stronger.

In 2021 we introduced a Diversity, Equity & Inclusion Committee, which is actively engaged in improving our culture, hiring

practices and education.

In 2021, we committed to the Parity Pledge – pledging to interview and consider at least one qualified

woman and underrepresented minority for every open role, VP or higher.

We prioritize recruiting, retaining, and incentivizing

a highly qualified, diverse workforce and we incentivize selected employees through the granting of stock-based awards for compensation

and performance and cash-based bonus awards for performance.

We have increased our focus on training and development

for our current employees.

We offer learning and development opportunities and other resources to support our employees in achieving and

enhancing their development objectives.

We equip our managers with the skills and tools to provide

ongoing coaching and feedback so employees can maximize their performance and potential, delivering success for the company and the employee.

Available Information

Our Internet address is www.optimizerx.com.

information on the website is not and should not be considered part of this Form 10-K and is not incorporated by reference in this Form

The website is, and is only intended to be, for reference purposes only.

We make available free of charge on or through our website

our Annual Report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, and amendments to those reports filed

or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) as

soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission

In addition, we will provide, at no cost, paper or electronic copies of our reports and other filings made with

Requests should be directed to:

Secretary, OptimizeRx Corporation, 400 Water Street, Suite 200, Rochester, MI 48307.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business