What changed in this filing

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Item 1. Business

2023-03-10 compared with 2022-02-28 · 184 added, 165 removed, 41 unchanged (89% of the section changed)

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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.

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, and Cyberdiet,

a controlled foreign corporation incorporated in Israel.

We employ a “land and expand” strategy

focused on growing our existing client base and generating greater and more consistent revenues in part through the continued shift in

our business model toward enterprise level engagements, while also broadening our platform with innovative proprietary solutions such

as our TelaRep™ virtual communication solution and our AI-powered real-world evidence solution which uses sophisticated proprietary

Industry Background

Life sciences organizations face a challenging

commercial landscape.

In recent years, they have met increased competition, shrinking market sizes, and inconsistent access to patients

and healthcare professionals - their most important customers.

The majority of new drug approvals, 81%, are specialty medications, leading

to more complex diagnosis criteria, increased utilization management by healthcare payors, and lengthy wait times for patients to begin

treatment once care decisions are made.

As a result, life sciences organizations have

increasingly turned to technology solutions to support their commercial strategies.

Spending on digital solutions to facilitate greater

access to their end markets accounts for one-third of their collective $30bn commercial spend in the United States (U.S.).

We believe significant opportunity exists to address

the unmet needs of life sciences organizations as they relate to digital solutions, including omni-channel access to health care professionals,

for complex commercial challenges.

2022 Company Highlights

Our net revenue increased to a record $61.3 million in 2021, a 42% increase over 2020.

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

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.

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

Our platform eliminates the need for physicians to manage and store physical drug samples by offering a more convenient and efficient way to allocate, administer and track samples and co-pay savings for their patients.

Today, nearly 60% of doctor offices ban or limit drug representatives and the samples they offer.

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.

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.

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.

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.

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

Our HIPAA-compliant, automated, mobile messaging platform allows pharmaceutical manufactures and related entities to directly engage with patients to improve regimen compliance.

We also deliver patient programs with treatment and affordability information, lifestyle and condition trackers, internet device connectivity, forms and surveys, with this all supported by a wide range of communication capabilities delivered via chat, bots, audio and telehealth.

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.

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.

Net revenue increased to a record $62.

5 million in 2022, a 2%

increase over 2021.

Achieved positive cash flow from operations of $10.7 million for

the year ended December 31, 2022.

Gross margins increased from 58% to 62%.

Repurchased 1,214,398 shares during 2022 at an average price of $16.49 per share.

Increased use of Real-World Data Artificial Intelligence (“RWD.AI”) solutions.

Ended the year

with 6 RWD.AI deals.

Acquired the EvinceMed platform and related assets.

Published Company’s first Environmental, Social and Governance (“ESG”) Report.

Announced partnership with Equals 5, becoming the only source capable of delivering true omni-channel engagement

with HCPs, spanning web, social, and point-of-care messaging delivery modalities.

Principal Solutions

Historically, we primarily facilitated financial

messages to health care providers via their EHR and ePrescribe systems using the OptimizeRx proprietary network to solve the ever-increasing

communication barriers between pharmaceutical representatives and healthcare providers.

Over time, as the demand for communication of

an increasing variety of different health information between life science companies, providers, and patients has risen, our platform

has expanded to encompass additional solutions that enable healthcare providers to access information for patients at the point of care.

These solutions include evidence-based physician engagement, point of care banner messaging, social network banner messaging, institutional

account-based banner messaging, innovative patient engagement services, and various accelerators to the therapy initiation workflow.

Our principal solutions can be summarized as follows:

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 RWD-enabled 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 currently care for qualified patients, based on

where they are in their care journey and disease state.

These Artificial Intelligence (“AI”) models provide our clients with

the most relevant targets and fuel the deployment of programs across our other solutions.

Point of Care Banner Messaging

– Our point of care banner messaging solution is utilized to deliver a variety of awareness (brand, therapeutic support,

affordability, HUB, and patient support program) and messaging within the clinical workflow which can be tailored to meet the needs

of each brand.

Social Network Banner Messaging

– This past year we expanded to provide exclusive access to deliver banner messaging to HCPs within their social network apps.

With extensive reach and granular reporting, this solution both expands the ability to reach more prescribers while adding to the mind

share we can capture throughout a care delivery day.

Given these messages are targeted to specific HCPs, many of the same awareness messages

offered on the point of care banner solution are offered here as well.

Institutional Account-based Banner Messaging

– Our Institutional Account-based Banner Messaging solution provides our clients access to delivering banner messaging online and

on the intranets of targeted health system accounts.

This allows our clients to capture additional mind share while also reaching other

prescribers and support staff at key health systems or integrated delivery networks (IDNs).

Financial Messaging – Our

Financial Messaging solution has been enhanced by Patient Support Messaging at the point-of-care.

This solution provides prescribers visibility

to branded copay offers and other patient support programs directly within their EHR and/or e-Prescribe system(s).

It allows them to print,

digitally send directly to patients via SMS, and/or digitally send copay offer details electronically to the dispensing pharmacy.

solution addresses the fact that many healthcare systems and prescribers are looking for an easier, more effective way to increase affordable

access and adherence to their prescribed branded medications.

Patient Engagement – Our technology

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

interactive health messaging for improved medication adherence and care coordination.

Our HIPAA-compliant, automated, mobile messaging

platform allows pharmaceutical manufactures and related entities to directly engage with patients to improve regimen compliance.

Therapy Initiation Workflow –

The therapy initiation workflow is a group of digital solutions focused on accelerating patient access to treatments where time-consuming

medical documentation is required of HCPs prior to pharmacies dispensing prescribed drugs.

These solutions support the fast-growing area

of specialty medications.

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

We employ a sales team of over 19

pe ople, marketing our solutions to new and existing clients.

Our sales team drives awareness of the increased value of our technology

stack as an enterprise platform, enhanced this year by the addition of the social channel, and momentum of our institutional/account-based

banner message solutions offering.

Accordingly, our sales efforts are not directed merely at selling individual solutions, but more broadly

towards selling enterprise platform engagements with access to our full set of solutions across our network.

and marketing organizations work closely together to cultivate customer relationships.

We use a number of methods to market and promote

our solutions, including digital advertising, industry events, trade shows, conferences, media coverage, social media and email.

released a physician survey of 100 physicians across five specialties, detailing the specialty landscape as it pertains to prescribing

pain points specialists experience.

Additionally, we hosted our third annual Innovate4Outcomes event, partnering with Melinta Therapeutics,

bringing individuals together across healthcare verticals, including HCPs, commercial manufacturer representatives, and health tech.

event focused on applying design thinking principles to contributing factors to Anti-Microbial Resistance, and was independently covered

in end-of-year trade publications for the first time.

To support our growth and provide maximum security,

scalability, and flexibility, all of our systems, including from acquisitions, are now hosted and integrated in the cloud.

Our technology

development and systems management core team is in the U.S.

and in Croatia, with contractors in India and Ukraine to provide bench depth,

rich skills experience, and business economies.

The teams are organized into Centers of Excellence focused on Product Domains, Quality

Assurance, Information Security, Data Warehousing and Business Intelligence, Platform Services, and Internal Systems Support.

Systems enhancements in 2022 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.

and documentation of processes and procedures and security implementation for ongoing Sarbanes Oxley, HIPAA, and customer assessments,

and in achieving Enterprise HITRUST Certification, as well as for other needs.

Our platforms face competition from numerous other

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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.

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 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.

and websites that provide savings on medications and healthcare products.

Our messaging offerings compete for pharmaceutical budgets with

a variety of other forms of advertising and promotion.

Our platforms compete 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.

Many of our competitors have greater financial, technical, product

development, marketing and other resources than we do.

These companies may be better known than we are and have more customers or users

As a result, many of these companies may respond more quickly to new or emerging technologies and standards and changes in

customer requirements.

These companies may be able to invest more resources in research and development, strategic acquisitions, and sales

and marketing.

The primary direct competitor 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.

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

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Intellectual Property

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.

We own 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,

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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.

In addition, we hold trademarks in the United

States and other countries.

As of December 31, 2022, OPTIMIZERx, OPTIMIZEMD, CareSpeak, DIETWATCH, Innovate4Outcomes, SPRx, SPx and TELAREP

are our registered trademarks.

We also have several pending trademark applications.

We also have licenses to intellectual property for the use and sale

of certain of our solutions.

In addition, we obtain other intellectual property rights and/or licenses used in connection with our business

when practical and appropriate.

Historically, we have created intellectual property or obtained intellectual property through commercial

relationships and in connection with acquisitions.

Government Regulation

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.

customers and partners are subject to 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.

Any new or amended laws or regulations that impose significant operational restrictions and compliance

requirements may negatively impact 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.

As of December 31, 2022, we had 94 full-time

employees in the U.S, as well as 15 full-time employees in Croatia, and 1 part-time employee.

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 and Croatia.

We supplement our workforce with contractors in the United States

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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.

stoppages.We are dedicated to maintaining an environment where everyone feels valued, and we celebrate both the differences and similarities

among our people.

We also believe that diversity in all areas, including cultural background, experience and thought, is essential in

making our Company stronger.

Our Diversity, Equity & Inclusion Committee (DE&I) is actively engaged in improving our culture,

hiring practices and education.

In 2022, we endeavored to uphold the Parity Pledge – a commitment made in 2021 to interview and

consider at least one qualified woman and underrepresented minority for every open role, VP or higher.

In addition, the DE&I Committee

sponsored quarterly events in 2022, including “Celebrate Women’s History”, “Celebrate Diversity Month”, and “Hot

One’s Trivia Show.”

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.

a highly qualified, diverse workforce.

We pay our employees competitively and offer a broad range

of company-paid benefits, which we believe are competitive with others in our industry.

Moreover, we believe our long-term incentives

are structured in a manner to provide time-based vesting schedules that are retentive and we incentivize selected employees through

the granting of stock-based awards for and cash-based performance bonus awards.

We have increased our focus on training and development

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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.

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

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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