Cumberland Pharmaceuticals Inc. Annual Report 2020

FY2020 Annual Report · Cumberland Pharmaceuticals Inc.

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2020

Improving
Patient Care.

Cumberland Pharmaceuticals is dedicated

to improving the quality of patient care through the delivery of high-quality prescription medicines. With a focus on
underserved niche markets, we continue to expand our reach – growing existing brands, adding innovative products,
and forging partnerships both domestically and around the globe. With a commitment to excellence, we are working
to address poorly met medical needs as we develop new medicine for the future.

Previously named
to the Inc 500’s fastest-
growing private companies
in the U.S., Cumberland
is now a publicly traded
company listed the
NASDAQ stock
exchange.

To Our Shareholders,
Employees & Partners:

Well, what a year it has been…

I am pleased to report that Cumberland has been able to
successfully manage through the pandemic, in spite of
the significant market headwinds and other challenges
that we encountered. Our facilities remained open, our
operations have continued, and we have been able to
keep our organization intact.

While there has been a significant impact on the hospital
admissions and physician office visits associated with
many of our brands, we are very fortunate to enjoy a
diversified product portfolio, along

with a diversified customer base.
We quickly adjusted our market
strategies, retooled our sales
communications and reinvented
the way in which we operate
our business. We developed
new methods to interact with
our customers and support the
patients that need our medicines.

As a result, we were able to generate another year of
overall revenue growth.

We launched several national initiatives during 2020
to help hospitals access our acute care brands during
the healthcare emergency. Our Vibativ® product was
used to help COVID-19 patients who developed bacterial
infections in their lungs. It is a potent antibiotic, FDA
approved to treat hospital-acquired and ventilator-
associated pneumonia that can result from a variety of
infectious organisms. It has been very rewarding to learn
of cases from across the country where Vibativ has been
successfully used to cure pneumonia in COVID patients.

I am also pleased to report that we introduced two
products in 2020.

• Early in the year, we implemented the national

launch of our Next Generation Caldolor® product
featuring a ready-to-use formulation in a pre-mixed
bag, offering time and cost savings associated with its
administration.

• We ended the year with the initial introduction of
our FDA-approved RediTrex® line of injectable
methotrexate products, featuring an innovative
delivery system for patients with arthritis.

We have been closely monitoring our supply chain
including the facilities that supply the raw materials, along
with those that manufacture our products. Overall, the
chain has remained intact with batches of finished goods
shipped to us and then onto the warehouses that supply
our country’s hospital and retail pharmacies. There was
one exception, as the facility packaging Omeclamox®-Pak
encountered financial difficulties due to the pandemic and
suspended operations.

We learned that they are reorganizing, and we are
awaiting a resumption of their operations.

Understandably, enrollment in our clinical trials
has declined due to closures and restrictions in the
institutions that recruit the needed patients. We are
working with the study sites as they reopen and look
forward to a resumption of patient accrual on a more
normalized basis, as we work toward the completion of
each clinical trial.

During 2020 we were able to maintain the compliance
and reporting requirements that apply to us as a publicly
traded, biopharmaceutical company. Those efforts
included hosting a successful FDA audit of our corporate
facility and processes.

Lastly, following an incredible year of change for
everyone, Cumberland remains steadfast on emerging
from the pandemic, with an outstanding organization
focused on maximizing the potential of our existing
brands, while continuing to build a portfolio of
differentiated products. I am confident the resilience
and ingenuity we discovered within our team this past
year has bolstered a strong foundation, that we can build
upon in 2021 and beyond.

I would like to acknowledge and thank my colleagues for
their continued dedication and valuable contributions.
Together, we remain focused on our mission of
advancing patient care through the delivery of high-
quality medicines.

All the best,

AJ Kazimi
Chairman and Chief Executive Officer

We are a unique company with quality
products that deliver real patient
solutions every day.

Cumberland markets seven FDA-approved brands in the United States. Our primary target
markets are hospital acute care and office-based gastroenterology and rheumatology.

We support our approved products in the U.S. through our hospital and field sales
divisions, along with an inside sales capability and team of medical science liaisons.

Our portfolio of FDA-approved brands includes:

(acetylcysteine)
Injection, for
the treatment of
acetaminophen
poisoning

(conivaptan) Injection,
to raise serum sodium
levels in hospitalized
patients with euvolemic
and hypervolemic
hyponatremia

During 2020, we
increased the
availability of Vibativ
to help COVID-19
patients battle their
hospital-acquired and
ventilator-associated
pneumonia.

We focus on select
medical specialties
including hospital
acute care,
gastroenterology
and rheumatology.

(ibuprofen) Injection,
for the treatment of
pain and fever

For more information on our
commercial products, visit
www.cumberlandpharma.com.

(lactulose) for Oral
Solution, a prescription
laxative, for the treatment
of chronic and acute
constipation

(methotrexate) Injection,
for the treatment of active
rheumatoid, juvenile
idiopathic and severe
psoriatic arthritis, as well
as disabling psoriasis

(telavancin) Injection, for the
treatment of certain serious
bacterial infections including
hospital-acquired and ventilator-
associated bacterial pneumonia,
as well as complicated skin and
skin structure infections

(omeprazole, clarithromycin,
amoxicillin) for the treatment
of Helicobacter pylori (H.
pylori) infection and related
duodenal ulcer disease

Cumberland launched
a new ready-to-use
presentation of Caldolor,
our opioid-alternative for
pain management.

Cumberland is
developing new
products to address
unmet medical
needs.

We are building a portfolio of
differentiated products.

We are working to transform Cumberland
by advancing our clinical pipeline. In order
to develop new medicines for the future, we
have continued to expand our pipeline and
have several promising product candidates in
development.

The Company has several Phase II clinical
programs underway, including evaluating
ifetroban in patients with cardiomyopathy
associated with Duchenne Muscular
Dystrophy – a debilitating, degenerative
disease, Systemic Sclerosis - one of the
deadliest autoimmune diseases and those
with Aspirin-Exacerbated Respiratory Disease
- a severe form of asthma.

This pipeline includes potential orphan drug
candidates that are designed to address
unmet medical needs by addressing patient
conditions for which there are no specific
treatments.

If one or more of these candidates are
approved, they have the potential to provide a
very significant impact for our company.

Our pipeline of product candidates includes:

Preclinical

IND

Phase 1

Phase 2

Phase 3

NDA

(aspirin-exacerbated respiratory disease) Boxaban®

(systemic sclerosis) Vasculan™

(Duchenne muscular dystrophy) Dyscorban™

Our
pipeline
of product
candidates
includes:

2020 Highlights

We aim to deliver high-quality medicines that
improve patient care while also achieving
sustained growth and profitability for our
shareholders. Our strategy for accomplishing
these key goals is multi-faceted – we add new

brands, expand product labeling, launch new
marketing programs and establish collaborations
to increase the availability of our products. Those
efforts have strengthened our market presence
and diversified our business.

pandemic. 1

Cumberland had a successful
year in spite of facing
significant market headwinds
and challenges associated
with the novel coronavirus

Early in the pandemic, we made a
special effort to ensure the availability
and distribution of our brands.

Several studies were
published during
2020 demonstrating
the ability of our
Caldolor (ibuprofen)
injection product to
reduce opioid use in
hospitalized patients.

In 2020, we undertook several
initiatives to keep our operations
open, our organization intact and
provide for the health and safety

of our team. 2

We held a national
infectious disease
symposium with experts
discussing the role
of Vibativ - our potent
antibiotic used to treat
life-threatening pneumonia
in COVID-19 patients.

In late 2020,
we entered the
rheumatology market with
the introduction of our
RediTrex (methotrexate)
product line.

We strive to deliver
solutions that help
reduce the overall
costs for healthcare
providers.

Cumberland offers
to cover a significant
percentage of Rx costs
for our gastrointestinal
and rheumatology
patients.

CET represents
an innovative
partnership
to build upon
breakthroughs in the
life sciences sector
and to advance
promising new
biopharmaceutical
technologies.

We are helping
to expand the biopharma
industry in our region and
around the world.

Cumberland Emerging Technologies (CET)

In order to be successful over the long-term, we believe it is crucial to build a pipeline of innovative new
product candidates. We formed Cumberland Emerging Technologies (CET) for just that purpose.

CET represents a joint initiative between Cumberland Pharmaceuticals Inc.; Vanderbilt University; our
state’s supported entrepreneurial ecosystem, Launch Tennessee; and an established international
partner, China’s WinHealth Pharmaceuticals.

The mission at CET is to identify promising research discoveries and advance the resulting
biopharmaceutical products on a development and commercial pathway towards the market.

• CET has established a
series of collaboration
agreements with a select
group of academic research
institutions located across
the mid-south region of the
U.S. - an area rich in scientific
research and innovation
yet underserved by the
biopharmaceutical industry.
We work with our university
partners to identify and
establish arrangements for
each new product candidate.
We then partner with the
university scientific team to
support product development
and also identify opportunities
to secure grant funding.

• CET has collaboration

agreements with Vanderbilt
University, the University of
Tennessee, the University of
Mississippi, Louisiana State
University, and the Medical
College of South Carolina.
These agreements allow us to
combine the strengths and
capabilities of each organization
by working together to identify
early-stage opportunities
and develop promising new
biomedical products to improve
patient care.

• CET’s offices and laboratories
are located in the CET Life
Sciences Center. Located in
downtown Nashville, the Center
houses CET’s activities and
fosters the emerging, local life
sciences industry. The facility
is a business incubator that
provides laboratory, office
space and equipment. It is
financially self-sufficient and
provides infrastructure tailored
to emerging companies seeking
a location for the development
of their technologies and
products.

Partnerships Around the World

We have an established infrastructure with the needed capabilities to support our focus
on the supply of our branded medicines for patients in the U.S.

We have also built a network of carefully selected international partners to bring our
medicines to patients in their countries. We have entered into a series of agreements
with a group of distinguished international companies who have the needed capabilities
to register and commercialize our brands in their territories.

1 Tennessee—

Cardinal Health Inc.
provides warehousing,
shipping and other
distribution support for
our products in the U.S.

2 Latin America—

Laboratorios Grifols, S.A.
is our commercial
partner for Caldolor®

3 Spain & Portugal—

Laboratorios Grifols, S.A.
is our commercial
partner for Caldolor®

4 Qatar —
GerminMED is our
commercial partner

for Caldolor®

5 India—

Sandor Medicaids Pvt. Ltd.
is our commercial partner
for Caldolor®

6 China—
WinHealth Pharma Group is our
commercial partner for Caldolor®
and Acetadote®, as well as an investor
in Cumberland Emerging Technologies

SciClone Pharmaceuticals is our

commercial partner for Vibativ®

Indonesia—

8
PT. ETHICA Industri Farmasi
is our commercial partner
for Caldolor®

9 Australia & New Zealand—

Seqirus™, a CSL Company, is our

commercial partner for Caldolor®

Phebra Pty Ltd., is our commercial
partner for Acetadote®

10 Russia—
R-Pharm JSC is our
commercial partner

for Vibativ®

7 South Korea—
DB Pharm Korea Co. Ltd. is our
commercial partner for Caldolor®
and Vibativ®

Our growth strategy involves maximizing the potential of our existing brands while continuing to
build a portfolio of differentiated products. The result of these efforts has strengthened our market
presence, diversified our revenue stream, and delivered revenue growth in 2020.

Selected Financial Data

(dollars in thousands except per share data)

2016

2017

2018

2019

2020

Net Revenues
Operating Income (Loss)
Net Income (Loss)

Total Assets
Long-Term Obligations
Total Equity

$ 32,187

(1,566)
(945)

$ 26,323
(8,879)
(7,979)

$ 29,345
(11,173)
(6,963)

$ 34,388
(9,288)
(3,538)

$ 37,441
(6,382)
(3,339)

93,405
5,491
73,121

93,232
11,616
63,922

112,694
29,319
55,571

104,549
29,314
51,085

96,463
23,922
46,873

Supplemental Financial Measures (Unaudited) (1)

Adjusted Earnings (Loss)
Adjusted Margin
Adjusted Diluted Earnings
(Loss) per Share

$ 1,683

$ (4,744)

$ (5,531)

(3,398)

5.2 %

(18.0) %

(18.8)%

(9.9) %

(146)

0.0 %

0.10

(0.29)

(0.35)

(0.22)

(0.01)

Reconciliation of Net Income (Loss) Attributable to Common
Shareholders to Adjusted Earnings and Adjusted Diluted
Earnings Per Share (1) (Unaudited)

(dollars in thousands except per share data)

2016

2017

2018

2019

2020

Net Income (Loss) Attributable to
Common Shareholders
Less: Net Loss at Subsidiary Attributable
to Noncontrolling Interests
Net Income (Loss)
Discontinued Operations
Net Income (Loss) from Continuing
Operations
Adjustments to Net Income (Loss)
Income Tax Expense (Benefit)
Depreciation and Amortization
Share-Based Compensation
Other Adjustments to Net Income (1)
Interest Income
Interest Expense
Adjusted Earnings
Adjusted Diluted Earnings per Share
Diluted Weighted-Average Common
Shares Outstanding:

$ (945)

$ (7,979)

$ (6,963)

(3,538)

(3,339)

59
(1,004)
133

71
(8,050)
4,798

76
(7,039)
3,782

9
(3,547)
5,665

80
(3,419)
3,207

(1,137)

(12,848)

(10,821)

(9,212)

(6,626)

(331)
2,397
852
–
(204)
106
$ 1,683
0.10
$

4,175
2,648
1,115
372
(299)
93
$ (4,744)
(0.29)
$

16
2,983
1,365
1,294
(564)
196
$ (5,531)
(0.35)
$

(79)
4,404
1,486
–
(243)
246
(3,398)
(0.22)

$
$

56
4,749
1,047
439
(75)
264
(146)
(0.01)

$
$

16,559

16,325

15,614

15,396

15,162

(1) The supplemental financial measures are Non-GAAP as defined, the reconciliation of these supplemental measures is above.

2020
Financial
Review

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Index

Page Number

PART I

Item 1: Business

Item 1A: Risk Factors

Item 1B: Unresolved Staff Comments

Item 2: Properties

Item 3: Legal Proceedings

Item 4. Mine Safety Disclosures

PART II

Item 5: Market for Registrant’s Common Equity, Related Stockholder Matters and

Issuer Purchases of Equity Securities

Item 6: Selected Financial Data

Item 7: Management’s Discussion and Analysis of Financial Condition and Results of

Operations

Item 7A: Quantitative and Qualitative Disclosures About Market Risk

Item 8: Financial Statements and Supplementary Data

Item 9: Changes in and Disagreements with Accountants on Accounting and Financial

Disclosure

Item 9A: Controls and Procedures

Item 9B: Other Information

PART III

PART IV

Item 15: Exhibits, Financial Statement Schedules

Item 16: Form 10-K Summary

SIGNATURES

PART I

Item 1. Business.

THE COMPANY

Cumberland Pharmaceuticals Inc. (“Cumberland,” the “Company,” or as used in the context of “we,” “us,” or
“our”), is a specialty pharmaceutical company focused on the acquisition, development and commercialization of
branded prescription products. Our primary target markets are hospital acute care, gastroenterology and
rheumatology. These medical specialties are characterized by relatively concentrated prescriber bases that we
believe can be penetrated effectively by small, targeted sales forces. Cumberland is dedicated to providing
innovative products that improve the quality of care for patients and address poorly met medical needs. We promote
our approved products through our hospital and field sales forces in the United States and are establishing a network
of international partners to register and provide our medicines to patients in their countries.

Our portfolio of FDA approved brands include:

•

Acetadote® (acetylcysteine) Injection, for the treatment of acetaminophen poisoning;

Caldolor® (ibuprofen) Injection, for the treatment of pain and fever;

• Kristalose® (lactulose) for Oral Solution, a prescription laxative, for the treatment of chronic and acute

constipation;

• Omeclamox®-Pak, (omeprazole, clarithromycin, amoxicillin) for the treatment of Helicobacter pylori (H.

pylori) infection and related duodenal ulcer disease;

•

Vaprisol® (conivaptan) Injection, to raise serum sodium levels in hospitalized patients with euvolemic and
hypervolemic hyponatremia;

Vibativ® (telavancin) Injection, for the treatment of certain serious bacterial infections including hospital-
acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure
infections; and

• RediTrex® (methotrexate) Injection, for the treatment of active rheumatoid, juvenile idiopathic and severe

psoriatic arthritis, as well as disabling psoriasis.

In addition to these commercial brands, we have Phase II clinical programs underway evaluating our ifetroban
product candidates in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy (“DMD”), a
degenerative disease, Systemic Sclerosis (“SSc”), a deadly autoimmune condition, and Aspirin-Exacerbated
Respiratory Disease ("AERD"), a severe form of asthma.

Cumberland has built core competencies in both product development and commercial capabilities. We have
established the capabilities needed to acquire, develop and commercialize branded pharmaceuticals in the U.S. and
believe we can leverage this existing infrastructure to support our expected growth. Our management team consists
of pharmaceutical industry veterans experienced in business development, product development, regulatory,
manufacturing, sales, marketing and finance. Our business development team identifies, evaluates and negotiates
product acquisition, licensing and co-promotion agreements. Our product development team creates proprietary
product formulations, manages our clinical studies, prepares all regulatory submissions and staffs our medical call
center. Our quality and manufacturing professionals oversee the manufacture, release and shipment of our products.
Our marketing and sales team is responsible for our commercial activities, and we work closely with our distribution
partners to ensure availability and delivery of our products.

Cumberland's growth strategy involves maximizing the potential of our existing brands, while continuing to
build a portfolio of differentiated products. We currently feature seven FDA products approved for sale in the United
States. Through our international partners, we are working to bring our medicines to patients in their countries. We
also look for opportunities to expand our products into additional patient populations through clinical trials, through
new presentations, and through our support for select, investigator-initiated studies. We actively pursue
opportunities to acquire additional marketed products, as well as late-stage development product candidates in our
target medical specialties. Our clinical team is developing a pipeline of new product candidates largely to address
poorly met and unmet medical needs.

We are supplementing these activities with the earlier stage drug development at Cumberland Emerging
Technologies ("CET"), our majority-owned subsidiary. CET partners with academic research institutions to identify
and progress promising, new product candidates, which Cumberland has the opportunity to further develop and
commercialize.

We were incorporated in 1999 and have been headquartered in Nashville, Tennessee since inception. During
2009, we completed an initial public offering of our common shares and listing on the Nasdaq stock exchange. Our
website address is www.cumberlandpharma.com. We make available through our website our Annual Reports on
Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all material press releases, other
filings and amendments to those reports as soon as reasonably practicable after their filing with the U.S. Securities
and Exchange Commission, (“SEC”). These filings are also available to the public at www.sec.gov.

COVID-19 Pandemic

In March 2020, the U.S. declared a health care emergency following the outbreak of the (SARS-CoV-2), a
novel strain of coronavirus that causes COVID-19, a respiratory illness. The Company managed through the
COVID-19 pandemic during 2020, continuing to operate our business - keeping facilities open and our organization
intact. We also maintained our ongoing compliance with the many laws and regulations that apply to us as a publicly
traded, pharmaceutical company.

Throughout the pandemic, Cumberland faced the same headwinds affecting other companies that rely on
hospital admissions and patient visits to drive revenue. Our business and our clinical studies were impacted as less
patients sought elective surgeries and our access to medical facilities was substantially limited. During 2020, we
carefully monitored our supply chain during the pandemic including the flow of raw materials into the plants that
manufacture our products as well as the batches of finished product emerging from those facilities. Several of our
brands were negatively impacted by the lockdowns and postponement of physician office visits and elective
procedures. However, we are fortunate to have a diversified product portfolio, with other brands delivering a strong
performance.

PRODUCTS

Our key products include:

Products

Indication

Acetadote®

Caldolor®

Kristalose®

Acetaminophen Poisoning

Pain and Fever

Chronic and Acute Constipation

Status

Marketed

Omeclamox®-Pak

H. pylori infection and related Duodenal Ulcer disease

Marketed

Vaprisol®

Vibativ®

RediTrex®

Acetadote®

Euvolemic and Hypervolemic Hyponatremia

Serious bacterial infections

Arthritis and psoriasis

Marketed

Approved

Acetadote is an intravenous formulation of N-acetylcysteine, indicated for the treatment of the liver toxicity
associated with acetaminophen poisoning. Acetadote has been available in the United States since Cumberland's
2004 introduction of the product through our hospital sales force. Acetadote is typically used in hospital emergency
departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common
ingredient in many over-the-counter and prescription pain relieving and fever-reducing products. Acetaminophen
overdose continues to be a leading cause of poisonings reported by hospital emergency departments in the United
States, and Acetadote has become a standard of care for treating this potentially life-threatening condition.

Acetadote received U.S. Food and Drug Administration ("FDA") approval as an orphan drug, which provided
seven years of marketing exclusivity from the date of approval. In connection with the FDA's approval of Acetadote,
we committed to certain post-marketing activities for the product. Completion of our first Phase IV commitment
resulted in the FDA's 2006 approval of expanded labeling for the product for use in pediatric patients. Completion of
our second Phase IV commitment resulted in further revised labeling for the product with FDA approval of
additional safety data in 2008. Completion of our third and final Phase IV commitment in 2010 culminated in the
FDA’s approval of a new formulation for the product. The next generation formulation, contains no ethylene
diamine tetracetic acid ("EDTA") or other stabilization agent, chelating agent or preservative. In early 2011,
Cumberland introduced this new Acetadote formulation replacing the original form of the product which we no
longer manufacture.

In June 2013, the FDA approved updated labeling for Acetadote revising the product's indication and providing
new dosing guidance for specific patient populations. As a result, dosing guidance is now included for patients
weighing over 100 kg, and new language has been added to alert health care providers that, in certain clinical
situations, therapy should be extended for some patients.

Beginning in 2012, the United States Patent and Trademark Office (the "USPTO") issued us a series of patents
associated with our Acetadote product. These patents are discussed in Part I, Item I, "Business - Trademarks and
Patents" of this Form 10-K. On November 8, 2012, we learned that the FDA approved an abbreviated new drug
application (ANDA) filed by InnoPharma, Inc. and referencing Acetadote. That product, with the old formulation
containing EDTA, was subsequently introduced by APP, a division of Fresenius Kabi USA, at the end of 2012.

In early 2013, we entered into an agreement with Perrigo Company resulting in the distribution of our
Authorized Generic acetylcysteine injection (our "Authorized Generic") product. Both Acetadote and our
Authorized Generic utilize the new, EDTA-free formulation which accounted for continued significant market share
during 2020.

In November 2015, an Illinois judge issued a final ruling in favor of Cumberland Pharmaceuticals Inc. in a
patent case associated with Acetadote. By ruling in Cumberland's favor, the court upheld the validity of the patent
which encompasses our EDTA-Free formulation and has a term until August 2025. The court also granted a
permanent injunction preventing challengers from marketing a generic version of our proprietary Acetadote product
formulation before the expiration of Cumberland’s patent in August 2025.

On January 26, 2017, an Appeals Court affirmed the District Court ruling in the Company's favor upholding

Cumberland's Acetadote patent and expressly rejected the validity challenge.

During 2020 we continued to distribute our Acetadote brand and, through Perrigo Company, our Authorized

Generic product.

Caldolor®

Caldolor, our intravenous formulation of ibuprofen, was the first injectable product approved in the U.S. for the
treatment of both pain and fever. We conducted a series of clinical studies in over nine hundred adult patients to
develop the data to support our FDA submission for the product's registration. The FDA approved Caldolor for
marketing in the United States in 2009 following a priority review. A non-steroidal anti-inflammatory drug
("NSAID"), the product was indicated for use in adults as a sole treatment for the management of mild to moderate
pain and for the management of moderate to severe pain as an adjunct to opioid analgesics. It was also the first FDA
approved intravenous therapy for treating fever.

In late 2009, we launched Caldolor and stocked the product at major wholesalers serving hospitals nationwide.
We initially worked to establish a core group of medical facilities approving and purchasing the product and then
focused on building more sales volume and treating a broader range of patients within those stocked facilities. We
promote Caldolor in the United States through our dedicated hospital sales force.

We completed a series of Phase IV studies to gather additional data to support our Caldolor product. Those
clinical trials involved another 1,000 patients, adult and pediatric patients. These studies included data on a
shortened infusion time and pre-surgical administration of the product. To address our Phase IV commitment to the
FDA, these studies also included evaluation of the product for the reduction of fever in hospitalized children and the
treatment of pain in children undergoing tonsillectomy surgeries.

In 2015 we received FDA approval for the use of Caldolor in pediatric patients six months of age and older.
Caldolor is the first and only injectable non-steroidal anti-inflammatory drug approved for use in children. We then
initiated a study to collect data on the use of Caldolor in children ranging in age from birth up to six months of age.
Enrollment in that study was completed in 2019.

In early 2018, we completed and filed the application for FDA approval of a next generation Caldolor product
featuring an improved presentation and formulation. In April 2018, the FDA determined that the application was
complete and notified us of their acceptance of the submission for review. There were then a number of
communications with questions addressed through multiple amendments that were submitted to the application.

In January 2019, the FDA approved the application for our next generation Caldolor product. The new,
premixed presentation provides healthcare professionals a formulation that is easy to administer, helping manage the
treatment of patient pain and fever, while reducing opioid consumption. It is provided in a pre-mixed bag containing
800 mg of ibuprofen in a 200 mL patented low sodium formulation for injection that is ready to use.

It is the first and only FDA-approved pre-mixed bag of ibuprofen. Caldolor is still available as an 800 mg/8mL

single–dose vial for dilution in addition to the ready-to-use bag.

In April 2019, we began initial shipments of this next generation Caldolor product to select customers. During
the third and fourth quarters of 2019, there was a growing demand for the new product from these select accounts. In
January 2020, we initiated a full-scale launch of this ready-to-use product. Unfortunately, the launch was impacted
by the COVID-19 pandemic and postponement of elective surgeries. Nonetheless, we do expect an improved
performance of the product after the pandemic abates as more accounts gain access to the new presentation.

During 2020 we distributed both the vial and the ready-to-use premixed bag presentations of Caldolor.

Kristalose®

Kristalose is a prescription laxative administered orally for the treatment of acute and chronic constipation. An
innovative, dry powder crystalline formulation of lactulose, Kristalose is designed to enhance patient acceptance and
compliance. Kristalose is the only prescription laxative available in pre-measured powder packets.

Kristalose dissolves easily in four ounces of water, offering patients a virtually taste-free, grit-free and
essentially calorie-free alternative to lactulose syrups. We conducted a preference study which indicated that
seventy-seven percent of patients surveyed prefer the taste, consistency and portability of Kristalose over similar
products in syrup forms.

We acquired exclusive U.S. commercialization rights to Kristalose in 2006, assembled a dedicated field sales
force and re-launched it in September 2006 as a Cumberland brand. We directed our sales efforts to physicians who
are the most prolific writers of prescription laxatives, including gastroenterologists and internists. We supplemented
this personal promotion with telemarketing campaigns to expand our reach and support of the product.

In late 2011, through a series of transactions, we entered into an agreement to acquire assets associated with the

Kristalose brand including the Kristalose trademark and the FDA registration.

Using preference data as a cornerstone of our marketing efforts, we repositioned the brand in early 2014. The
marketing strategy included an enhanced patient coupon program and expanded managed care coverage for the
product.

We added a co-promotion partner to provide support for the brand in 2017. Poly Pharmaceuticals is promoting
Kristalose to physician targets not covered by our field sales forces. In 2018, we added another partner, Foxland
Pharmaceuticals, Inc., who is repackaging Kristalose and featuring it with additional new physician targets.

During 2020 we continued to support Kristalose through our field sales force as well as our partnerships with

Poly Pharmaceuticals and Foxland Pharmaceuticals, Inc.

Omeclamox®-Pak

Many ulcers of the gastrointestinal tract are caused by an infection from the Helicobacter pylori (“H. pylori”)
bacterium. Omeclamox-Pak is a branded prescription product used for the treatment of these infections and the
related duodenal ulcer disease. This innovative product combines three well-known and widely prescribed
medications: omeprazole, clarithromycin, and amoxicillin.

Omeclamox-Pak was the first FDA approved triple therapy combination medication to contain omeprazole as
the proton pump inhibitor, which works to decrease the amount of acid the stomach produces. Clarithromycin and
amoxicillin are both antibiotic agents which hinder the growth of the H. pylori bacteria.

Interaction of these agents allows the stomach lining to heal effectively. The medications are packaged together

on convenient daily dosing cards, making it simple to follow the twice a day dosing before meals.

While there are competing combination products, Omeclamox-Pak is one of the few actively marketed brands
for this condition. In addition, compared to the competitors, Omeclamox-Pak involves the lowest pill burden and
fewest days of therapy. Our involvement with Omeclamox-Pak began in October 2013, through a co-promotion
agreement with Pernix Therapeutics ("Pernix").

In November 2015, Cumberland entered into an exclusive license and supply agreement with Gastro-Entero
Logic, LLC (“GEL”), assumed full commercial responsibility for Omeclamox-Pak in the United States, and
concluded our agreements with Pernix. Cumberland became responsible for the distribution, national accounts and
all sales promotion of Omeclamox-Pak under the GEL agreement.

In December 2018, we completed an agreement with GEL to acquire all remaining assets associated with
Omeclamox-Pak including the product’s FDA approval as well as the domestic and international trademarks. The
closing of this transaction ended Cumberland’s payments of royalties and manufacturing fees to GEL, and we
assumed responsibility for the maintenance of the product’s FDA approval and for the oversight of the product’s
manufacturing and packaging.

Our field sales force has promoted Omeclamox-Pak to the gastroenterology market segment, which accounts for
the largest component of the prescriber base for this product. We supplemented this personal promotion through
telemarketing campaigns to expand the support and use of the product. We have also established a series of contracts
to provide managed care coverage for Omeclamox-Pak.

The packager for Omeclamox-Pak encountered financial difficulties in 2020 due to the impact of COVID-19,
and their operations are currently suspended. We are awaiting resumption of those operations, while also exploring
other alternatives to restart the product’s packaging. We have notified the FDA that the product is currently not
available.

Vaprisol®

In early 2014, we entered into an agreement with Astellas Pharma US, Inc. ("Astellas") to acquire Vaprisol,
including certain product rights, intellectual property and related assets. Vaprisol is a prescription brand indicated to
raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia. The product was
developed and registered by Astellas. It is one of two branded prescription products indicated for the treatment of
hyponatremia, and the only intravenously administered branded treatment.

Hyponatremia, an imbalance of serum sodium to body water, is the most common electrolyte disorder among
hospitalized patients. These electrolyte disturbances occur when the sodium ion concentration in the plasma is
lower than normal and are often associated with a variety of critical care conditions including congestive heart
failure, liver failure, kidney failure and pneumonia. Vaprisol raises serum sodium to appropriate levels and promotes
free water secretion.

Vaprisol is supported by our hospital sales division. Demand for the product increased during the 2020

pandemic, and we worked to ensure availability of the product to hospitals and clinics during the health care crisis.

Vibativ®

In November 2018, the Company announced an agreement with Theravance Biopharma ("Theravance") to
acquire the Vibativ assets from Theravance and assume global responsibility for the brand including the related
marketing, distribution, manufacturing and regulatory activities.

Vibativ is a patented, FDA approved injectable anti-infective for the treatment of certain serious bacterial
infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin
structure infections. It addresses a range of Gram-positive bacterial pathogens, including those that are considered
difficult-to-treat and multidrug-resistant.

Immediately after the closing, we initiated shipments of Vibativ, assumed responsibility for the supply chain
and distribution of the product in the U.S. and transitioned the brand's responsibilites from Theravance to
Cumberland. Vibativ is supported by our hospital sales division.

During 2020, demand for the product grew, and it was used to treat pneumonia resulting from secondary

bacterial infections in hospitalized COVID-19 patients.

RediTrex®

In November 2016, we announced an agreement with Nordic Group B.V. to commercialize their methotrexate
product line in the United States. This new line of injectable products is designed for treating patients with arthritis
and psoriasis. Cumberland is responsible for the registration and commercialization of these products while Nordic
will manage the product supply. Nordic has registered and is selling their methotrexate products in several European
countries.

During late 2018, we completed the submission and filed with the FDA a New Drug Application for our
methotrexate products. In December 2019, we received FDA approval for RediTrex and began planning for a launch
of this product line. In November 2020, we provided initial shipments of RediTrex to select accounts and began
preparing for a national launch in the second half of 2021, once product supplies are assured and market conditions
return to normal.

PIPELINE

Our development pipeline includes a series of product candidates in Phase II development. During 2020,
enrollment in our studies significantly slowed during the pandemic, due to trial suspensions and the decrease in
eligible patient admissions to medical centers across the country. We look forward to an improvement as the
pandemic subsides and centers begin to reopen with a return of patients eligible for our trials.

Our clinical programs include the evaluation of ifetroban in the following areas:

Aspirin-Exacerbated Respiratory Disease ("AERD")

We have completed the manufacturing and initiated clinical development of an oral formulation of ifetroban
under the brand name Boxaban. We are evaluating this candidate for patients suffering from Aspirin-Exacerbated
Respiratory Disease ("AERD"), also known as Samter’s Triad, a chronic medical condition that consists of three
clinical features: asthma, sinus disease with nasal polyposis and sensitivity to aspirin. AERD is characterized by
sharp increases in inflammatory mediators and platelet activity within the respiratory system. Approximately one in
twenty asthmatic adults in the U.S. suffer from AERD and awareness of the disease is growing within the medical
community. There is no U.S. approved pharmaceutical treatment for AERD.

We completed an initial Phase II clinical study to evaluate the safety and tolerability of Boxaban in AERD
patients. The multicenter study involved sixteen patients at several U.S. medical centers led by the Scripps Research
Institute. Results indicated that Boxaban was well tolerated with no safety concerns noted in patients with a history
of AERD.

In early 2017, the FDA cleared Cumberland’s IND application for the Company’s AERD clinical program.
Following this clearance, we initiated a follow-on multicenter Phase II efficacy study to evaluate the efficacy of
Boxaban in seventy-six patients with symptomatic AERD.

Systemic Sclerosis ("SSc")

In April 2016, we announced the addition of Vasculan to our pipeline. Through Cumberland's ifetroban
program, Cumberland has initiated the clinical development of ifetroban oral capsules for the treatment of systemic
sclerosis.

Systemic sclerosis ("SSc"), also called scleroderma, is a debilitating autoimmune disorder characterized by
diffuse fibrosis of the skin and internal organs, as well as vascular dysfunction. Preclinical studies have shown that
ifetroban prevents and can restore cardiac function in a preclinical model of pulmonary arterial hypertension.

This disease has a high morbidity and the highest case-specific mortality of any rheumatic disorder with 50%
of patients dying or developing major internal organ complications within 3 years of diagnosis. Although several
medications are used to treat the skin disease associated with SSc, there is no universally effective treatment to
improve the function of affected internal organs such as the lungs, heart, and gastrointestinal tract.

The FDA has cleared our IND application to evaluate the safety and efficacy of Vasculan in patients with SSc.

As a result, we initiated a Phase II multicenter study in thirty-four SSc patients.

Duchenne Muscular Dystrophy ("DMD")

On September 24, 2019, Cumberland announced an FDA Orphan Drug Grant funding for a new Phase II

clinical program. The Company has initiated the clinical development of ifetroban for the treatment of
cardiomyopathy associated with Duchenne Muscular Dystrophy (“DMD”). Based on preclinical findings, the FDA
has cleared Cumberland’s application to study ifetroban in DMD patients, 7 years of age and older. In addition,
Cumberland has been awarded just over $1 million in funding from the FDA through their Orphan Drug Grant
program to support this Phase II DMD clinical study. It is the first DMD clinical study approved for FDA Orphan
Product Development funding. During 2020 the FDA awarded a supplemental grant in support of the Phase II study.

Other Clinical Programs

We have also completed Phase II clinical programs with ifetroban in patients with Hepatorenal Syndrome
(“HRS”) and patients with Portal Hypertension (“PH”). Additional pilot studies of ifetroban are underway including
several investigator-initiated trials. We are awaiting further study results before deciding on the best path for
approval for ifetroban, our first new chemical entity.

New Hospital Product Candidate

Cumberland was responsible for the formulation, development and FDA approval of both Acetadote and
Caldolor. Our Medical Advisory Board has helped us identify additional opportunities that address unmet or poorly
met medical needs. As a result, Cumberland has successfully designed, formulated and completed the preclinical
studies for a cholesterol reducing agent for use in the hospital setting.

During 2017, we completed a Phase I study which defined the pharmacokinetic properties and provided a
favorable safety profile for this new product candidate. The study results and a proposed clinical development plan
were discussed with the FDA. A Phase II study has been initiated and and patient enrollment completed. We have
completed the study report, filed it with the FDA and are now determining the next steps for this program.

OUR STRATEGY

Our growth strategy involves maximizing the potential of our existing brands while continuing to build a
portfolio of differentiated products. We currently market seven FDA approved products for sale in the United States.
Through our international partners, we are working to bring our products to patients in their countries. We also look
for opportunities to expand our products into additional patient populations through clinical trials, new indications,
and select investigator-initiated studies. We actively pursue opportunities to acquire additional marketed products as
well as late-stage development product candidates in our target medical specialties. Our clinical team is developing a
pipeline of new product candidates to address unmet medical needs. Further, we are supplementing these activities
with the early stage drug development activities at CET, our majority-owned subsidiary. Specifically, we are seeking
long term sustainable growth by executing the following plans:

Support and expand the use of our marketed products. We continue to evaluate our products following their
FDA approval to determine if additional clinical data could expand their market and use. We will continue to
explore opportunities for label expansion to bring our products to new patient populations. As examples, we have
secured pediatric approval, expanding the labeling for both our Acetadote and Caldolor brands.

Selectively add complementary brands. In addition to our product development activities, we are also seeking to
acquire products or late-stage development product candidates to continue to build a portfolio of complementary
brands. We focus on under-promoted, FDA-approved drugs as well as late-stage development products that address
poorly met medical needs. We will continue to target product acquisition candidates that are competitively
differentiated, have valuable intellectual property or other protective features, and allow us to leverage our existing
infrastructure. Our acquisition of Vibativ represents the largest product acquisition we have completed.

Progress clinical pipeline and incubate future product opportunities at CET. We believe it is important to build
a pipeline of innovative new product opportunities. Our ifetroban Phase II development programs represent the
implementation of this strategy. At CET, we are supplementing our acquisition and late-stage development activities
with the early-stage drug development activities. CET partners with universities and other research organizations to
develop promising, early-stage product candidates, which Cumberland has the opportunity to further develop and
commercialize.

Leverage our infrastructure through co-promotion partnerships. We believe that our commercial infrastructure
can help drive prescription volume and product sales. We look for strategic partners that can complement our
capabilities and enhance the opportunity for our brands. Our co-promotion partnership with Poly Pharmaceuticals,
Inc. and Foxland Pharmaceuticals, Inc. allow us to expand the support for Kristalose across the United States.

Build an international contribution to our business. We have established our own commercial capabilities,
including two sales divisions to cover the U.S. market for our products. We are also building a network of select
international partners to register our products and make them available to patients in their countries. We will
continue to develop and expand our network of international partners while supporting our partners’ registration and
commercialization efforts in their respective territories. The acquisition of Vibativ resulted in several new
international partners and market opportunities.

Manage our operations with financial discipline. We continually work to manage our expenses in line with our
revenues in order to deliver positive cash flow from operations. We remain in a strong financial position, with
favorable gross margins, and a strong balance sheet.

SALES AND MARKETING

Our sales and marketing team has broad industry experience in selling branded pharmaceuticals. Our sales and
marketing professionals manage our dedicated hospital and gastroenterology sales forces, including approximately
50 sales representatives and district managers, direct our national marketing campaigns and maintain key national
account relationships.

Hospital market: We promote Caldolor, Vaprisol, Acetadote, and Vibativ through our dedicated hospital
sales division. This organization targets key hospitals across the U.S. and is comprised of sales
professionals with substantial experience in the hospital market. Independent market data continues to
indicate that the majority of pharmaceutical promotional spending is directed toward large, outpatient
markets on drugs intended for chronic use rather than short-term, hospital use.

We believe the hospital market is under-served and highly concentrated, and that it can be penetrated
effectively by a small, dedicated sales force without large-scale promotional activity. Our established
position in the hospital market provided the rationale for adding Vibativ as our first infectious disease
product that complement our hospital product line. Our strategy has been to increase the focus of our
hospital sales team on targeted, high priority accounts.

Gastroenterology and rheumatology market: We promote Kristalose, Omeclamox-Pak and RediTrex
through a dedicated field sales team addressing a targeted group of physicians who are large prescribers of
the products. Because the markets for gastrointestinal and rheumatology diseases are broad in patient scope,
yet relatively narrow in physician base, we believe they provide opportunities that can be penetrated with a
modest sized sales force. By investing in our sales and marketing activities we believe that we can increase
market share for these products.

Our commercial executives conduct ongoing analyses to evaluate marketing campaigns and promotional
programs in support of our brands. The evaluations include development of product profiles, testing of the profiles
against the needs of the market, determining what additional product information or development work is needed to
effectively market the products and preparing financial forecasts.

We utilize professional branding and packaging as well as promotional items to support our products, including
direct mail, sales brochures, journal advertising, educational and reminder leave-behinds, patient educational pieces,
coupons, and product sampling. We also regularly attend select medical meetings and trade shows to expand the
awareness of our products.

Our national accounts function is responsible for key large buyers and related marketing programs. National
accounts maintain relationships with our wholesaler customers as well as with third-party payors such as group
purchasing organizations, pharmacy benefit managers, hospital buying groups, state and federal government
purchasers and health insurance companies.

MATERIAL CUSTOMERS

Our primary customers are wholesale pharmaceutical distributors in the United States. Total revenue by
customer for each customer representing 10% or more of consolidated gross revenues are summarized below for the
year ended December 31, 2020:

Customer 1
Customer 2
Customer 3

2020

25%
25%
21%

INTERNATIONAL PARTNERSHIPS

We have established our own capabilities to support the commercialization of our products in the U.S. Our
international strategy is to identify and partner with other companies that have the appropriate capabilities to support
our products in their respective countries. We have entered into a series of agreements to establish an international
network, which is summarized in the table below and includes information on our primary partners:

International Partner

Product(s)

Territory

Status

Phebra Pty Ltd

Acetadote

Australia and New Zealand

DB Pharm Korea Co., Ltd.

Caldolor

South Korea

Seqirus (a CSL company)

Caldolor

Australia and New Zealand

Sandor Medicaids Pvt. Ltd.

GerminMED

R-Pharm JSC

PT. ETHICA Industri Farmasi

Laboratorios Grifols, S.A.

Caldolor

Vibativ

Caldolor

India, Pakistan, Bangladesh and Nepal

Qutar

Russia

Indonesia

Spain, Portugal and South America

SciClone Pharmaceuticals, Inc.

Vibativ

China and Hong Kong

WinHealth Pharma Group Co.

Caldolor &
Acetadote

China and Hong Kong

Marketed
Marketed

Marketed

Registration

Development

Our international commercialization agreements include a license to one or more Cumberland products for a
specific territory as noted in the table above. We seek partners who have the local infrastructure to support the
registration and commercialization of our products in their territory.

Under the terms of our agreements our partners are responsible for:

•

Seeking regulatory approvals for the products;

Launching the brand;

Managing the ongoing marketing, sales and product distribution;

Addressing the ongoing regulatory requirements in the international territories;

Remitting any upfront, regulatory and sales milestone payments;

Providing the transfer price for supplies of product; and

Calculating and paying any royalties, as applicable.

Our responsibilities include:

•

Providing a dossier of relevant information to support product registration;

Maintaining our intellectual property associated with the product;

Sharing our marketing strategy, experience and materials for the brand; and

Manufacturing and providing finished product for sale.

During 2020, we worked to support our existing international partners and to identify new companies to

represent our products in select additional territories.

CLINICAL AND REGULATORY AFFAIRS

We have in-house capabilities for the management of our clinical, professional and regulatory affairs. Our team
develops and manages our clinical trials, prepares regulatory submissions, manages ongoing product-related
regulatory responsibilities and manages our medical information call center. Team members have been responsible
for devising the regulatory and clinical strategies for all our products as well as obtaining FDA approvals for
Acetadote, Caldolor and RediTrex.

Clinical development

Our clinical development personnel are responsible for:

•

creating clinical development strategies;

designing, implementing and monitoring our clinical trials; and

creating case report forms and other study-related documents.

Regulatory and quality affairs

Our internal regulatory and quality affairs team is responsible for:

•

preparing and submitting INDs for clearance to begin patient studies;

preparing and submitting NDAs and fulfilling post-approval marketing commitments;

• maintaining investigational and marketing applications through the submission of appropriate reports;

•

submitting supplemental applications for additional label indications, product line extensions and
manufacturing improvements;

evaluating regulatory risk profiles for product acquisition candidates, including compliance with
manufacturing, labeling, distribution and marketing regulations;

• monitoring applicable third-party service providers for quality and compliance with current Good
Manufacturing Practices ("GMPs"), Good Laboratory Practices ("GLPs"), and Good Clinical Practices
("GCPs"), and performing periodic audits of such vendors; and

• maintaining systems for document control, product and process change control, customer complaint

handling, product stability studies and annual drug product reviews.

PROFESSIONAL AND MEDICAL AFFAIRS

Our medical team provides in-house, medical information support for our marketed products. This includes
interacting directly with healthcare professionals to address any product or medical inquiries through our medical
information call center and medical science liaisons. In addition to coordinating the call center, our clinical/
regulatory group generates medical information letters, provides informational memos to our sales forces and assists
with ongoing training for the sales forces.

CLINICAL DEVELOPMENT AND STUDY RESULTS

Vibativ Clinical Manuscripts

Vibativ is a patented, FDA-approved injectable anti-infective for the treatment of certain serious bacterial
infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin
structure infections. It addresses a range of Gram-positive bacterial pathogens, including those that are considered
difficult-to-treat and multidrug-resistant. In November 2018, Cumberland reached an agreement to acquire Vibativ
from Theravance Biopharma and assume global responsibility for the product.

In late 2019, we announced a publication in Infectious Diseases and Therapy, with study results showing
numerically superior cure rates of telavancin compared to vancomycin within a subset of patients who were enrolled
in Phase 3 ATTAIN trials and had hospital-acquired pneumonia caused by bacteria with low susceptibility to
vancomycin. Additionally, an online publication in Drugs - Real World Outcomes, detailed the positive clinical
outcomes that resulted from treating multiple infection types with Vibativ, including complicated skin infections,
bone and joint infections, bacteremia and endocarditis, and lower respiratory tract infections.

In May 2020, Cumberland announced a new study published in Drugs - Real World Outcomes, detailing the
positive clinical outcomes that resulted from treating patients with bacteremia or endocarditis with Vibativ. This
publication is a sub analysis of The Telavancin Observational Use Registry (TOUR™), a study conducted to record
population characteristics, prescription information, and real-world clinical outcomes of patients with Gram-positive
infections treated with Vibativ. The analysis suggests Vibativ is a promising and viable option for patients with
bacteremia or endocarditis, including those with MRSA or another S. aureus pathogen.

Additionally, in May 2020, we announced the publication of two studies confirming the continued in vitro
potency of telavancin. Both publications were part of continued surveillance of telavancin activity since 2011. The
first publication tested a global collection of 24,408 Gram-positive clinical isolates, and the second publication
tested a U.S. collection of 15,882 S. aureus isolates. Both studies documented the sustained in vitro antimicrobial
activity and spectrum of telavancin—many years after its clinical approval—against Gram-positive clinical isolates
collected worldwide over 7 years, from 2011 through 2017.

Caldolor Clinical Manuscripts

In July 2020, Cumberland announced a study published in the Journal of Orthopedic Trauma, evaluating the
efficacy of Caldolor administration in the management of acute pain in orthopedic trauma patients. The study also
measured Caldolor’s ability in minimizing opioid use. This single-center, randomized, double-blind, placebo-
controlled study found that Caldolor (ibuprofen) Injection reduced the quantity of opioids required to manage pain
after a traumatic injury with fracture. In addition, the time to first narcotic medication was longer in the Caldolor
group than with hospital standard of care. Pain was also managed better in the Caldolor group compared to standard
of care narcotics.

Additionally, in August 2020, we announced the results of a review of nine clinical studies evaluating Caldolor.
The comprehensive review was published in the journal Clinical Therapeutics and involved 1,062 adult patients,
with 757 receiving Caldolor and 305 receiving placebo or a comparator medication. The data noted that the use of
Caldolor improved post-surgery recovery, decreased surgical stress, and reduced the use of opioids and over-the-
counter medication. The study determined that patients given Caldolor experienced less postoperative pain and
decreased opioid use. Study authors also concluded that the rapid administration and preemptive use of Caldolor
should be considered in Enhanced Recovery After Surgery protocols for the management of postoperative pain
including that of traumatic origin.

Caldolor Newborn Study

We previously received FDA approval for the use of Caldolor in pediatric patients six months of age and
older. Caldolor is the first and only injectable NSAID approved for use in children. We then initiated a study to
collect data on the use of Caldolor in children ranging in age from birth up to six months of age. Enrollment in that
multi-center study was completed in 2019, and topline results were announced in 2020, indicating that Caldolor was
well tolerated in this patient population, with no safety concerns noted.

Ifetroban Phase II Studies

We have been evaluating our ifetroban product candidate in a series of clinical studies. We have three Phase II
clinical programs underway evaluating our ifetroban product candidates in 1) patients with cardiomyopathy
associated with Duchenne Muscular Dystrophy, a rare, fatal, genetic neuromuscular disease results in deterioration
of the skeletal, heart and lung muscles, 2) Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder
characterized by diffuse fibrosis of the skin and internal organs and 3) Aspirin-Exacerbated Respiratory Disease, a
severe form of asthma.

In addition, we have completed two pilot Phase II studies involving 1) patients suffering from Hepatorenal
Syndrome, a life-threatening condition involving liver and kidney failure and 2) patients with Portal Hypertension
associated with chronic liver disease.

Additional pilot studies of ifetroban are underway, including several investigator-initiated trials.

Enrollment in our clinical studies was interrupted during 2020 due to the COVID-19 pandemic. While
enrollment of new patients is currently limited, we have worked to ensure that patients already entered into a trial
continue to receive their study drug. Many of our clinical study sites have reopened and resumed screening of
patients for potential enrollment into our studies. We are awaiting results from the studies underway before deciding
on the best development path for the registration of ifetroban, our first new chemical entity.

New Hospital Product Candidate Study

A Phase II study has been initiated and patient enrollment completed. We have completed the study report,

filed it with the FDA and are now determining the next steps for this product development program.

BUSINESS DEVELOPMENT

Since inception, we have had an active business development program focused on acquiring rights to marketed
products and product candidates that fit our strategy and target markets. We source business development
opportunities through our international network of advisory firms and individual pharmaceutical industry and
medical advisors. A multi-disciplinary internal management team reviews these opportunities on a regular basis
using a list of selection criteria. We have historically focused on product opportunities that are a strategic fit with our
commercial organization, development expertise and medical focus, employing a variety of transaction structures.

We intend to continue to build a portfolio of complementary, niche products largely through product

acquisitions and late-stage product development.

Our primary targets are under-promoted, FDA approved drugs with existing brand recognition and late-stage
development product candidates that address unmet or poorly met medical needs in the hospital acute care and
gastroenterology markets. We believe that by focusing mainly on approved or late-stage products, we can minimize
the significant risk, cost and time associated with drug development.

Early in 2019, we announced a strategic review of our brands, capabilities, and international partners. This
review followed an accelerated business development initiative, which resulted in a series of transactions. Because
of that progress, we felt that it was prudent to take a fresh look at our product portfolio, partners, and organization to
ensure proper focus and capabilities.

International Partners

As a result of our strategic review, we altered our international arrangements through several new agreements as

well as dissolution of prior agreements..

We executed a License and Distribution agreement with HongKong WinHealth Pharma Group Co. Limited
(“WinHealth”) for our Caldolor and Acetadote brands in China and Hong Kong. Under the terms of the agreement,
WinHealth will provide development milestone payments and purchase supplies of the products following their
registration in China.

We also entered into a Strategic Alliance agreement with WinHealth to explore future business opportunities
that will further the mission and goals of each organization. Founded in Hangzhou, China and currently
headquartered in Hong Kong, WinHealth has developed a wide breadth of capabilities including drug licensing,
product development and registration, and has established a strong network of distribution and sales promotional
capabilities for the Chinese market. WinHealth has established partnerships with international companies that
include Boehringer-Ingelheim, Janssen, Novartis, Pfizer, and Roche, generating approximately $330 million in
annual sales in 2018.

In August 2020, we entered into an agreement with WinHealth Investment (Singapore) Ltd creating WHC
Biopharmaceuticals, Pte. Ltd. The joint venture will focus on acquiring, developing, registering, and
commercializing development stage and commercial stage biopharmaceuticals for China, Hong Kong and other
Asian markets.

Additionally, we completed the assignment and amendment of a Commercialization Agreement with R-Pharma
JSC (“R Pharma”) associated with ongoing distribution of Vibativ in Russia and a number of adjacent countries in
Eastern Europe. R-Pharma is one of the leading multinational pharmaceutical organizations based in Russia.
Headquartered in Moscow and focusing in a wide breadth of therapeutic areas in the specialty and hospital care
markets, R-Pharma generated over $1.6 billion in revenues in 2018.

We are in the process of concluding our Commercialization Agreement with Hikma Pharmaceuticals LLC to
register and distribute Vibativ in a number of countries throughout the Middle East, our agreement with Dr. Reddy’s
Laboratories Limited for the registration and distribution of Vibativ in India, and our License and Distribution
Agreement with PT. EHTICA Industri Farmasi for the registration and distribution of Caldolor in Indonesia.

Poly Co-Promotion Agreement

We entered into a co-promotion arrangement with Poly Pharmaceuticals, Inc. (“Poly”) for our Kristalose
product in 2017. Poly is a privately held U.S. specialty pharmaceutical company that is featuring Kristalose to an
expanded number of physicians. Poly’s sales organization is more than doubling the number of nationwide
physicians that are reached with the Kristalose brand message. During 2019, we extended our co-promotion
arrangement with Poly.

Nordic License Agreement

In November 2016, we announced our agreement to acquire the exclusive U.S. rights to Nordic Group B.V.'s
injectable methotrexate product line. The products are designed for the treatment of active rheumatoid arthritis,
juvenile idiopathic arthritis, severe psoriatic arthritis, and severe disabling psoriasis.

The product line is approved for patient use in various European countries and received FDA approval near the
end of 2019. Cumberland has registered and is commercializing the methotrexate products in the United States
under the brand name RediTrex.

2R and Foxland Agreements

During 2018, we entered into another co-promotion arrangement related to our Kristalose product. We have
agreements with 2R Investments, LLC and with Foxland Pharmaceuticals, Inc. to package, distribute and promote
an authorized generic form of our Kristalose product to physician targets that we do not cover. Cumberland
continues to manage the regulatory activities associated with the product.

Clinigen Strategic Dissolution Agreement

We previously entered into a strategic alliance with the Clinigen Group plc ("Clinigen"), an international
specialty pharmaceutical and services company, to commercialize select Clinigen products in the U.S. In May 2016,
we announced an agreement with Clinigen to acquire an exclusive license and commercialize Ethyol® in the U.S.
We then announced in January 2017, our second agreement with Clinigen to acquire an exclusive license and launch
Totect® in the U.S.

During May 2019, following a strategic review of our partners, products and organization, we entered into a
Dissolution Agreement with Clinigen in which Cumberland will return the exclusive rights to commercialize Ethyol
and Totect in the United States to Clinigen. Under the final terms of the amended Dissolution Agreement we
transitioned from our current arrangement with Clinigen effective December 31, 2019. Under the terms of the
agreement, Cumberland will no longer be involved directly or indirectly with the distribution, marketing and
promotion of either Ethyol or Totect or any competing products. In exchange for the return of these product license
rights and not competing with either product, we will receive $5 million in financial consideration paid over the two-
years following December 31, 2019.

CET University Collaboration Agreements

Through CET, we collaborate with a select group of academic research institutions located in the mid-south
region of the U.S. to identify, co-develop and seek grant funding for promising biomedical technologies emerging
from those research institutions.

CET is collaborating with Vanderbilt University, the University of Mississippi, the University of Tennessee
Research Foundation, Louisiana State University, and the Medical University of South Carolina to identify, co-
develop and seek grant funding for promising biomedical technologies emerging from those research institutions.

These arrangements enable CET to team with university-based researchers to advance their scientific
discoveries and breakthroughs by designing new product candidates to improve patient care and address unmet
medical need.

MANUFACTURING AND DISTRIBUTION

Manufacturing

We partner with third parties for certain non-core, capital-intensive capabilities, including the manufacturing
and distribution of our products. We manage these third-party relationships and are responsible for the quality
review and release of each lot of our products.

Acetadote®

For Acetadote we had agreements with two manufacturers, and one manufacturer provided commercial supplies

of the product during 2020.

Caldolor®

We have agreements with multiple manufacturers for the supply of Caldolor and during 2020 we obtained

commercial supplies from three of these manufacturers for our international and domestic Caldolor requirements.

Kristalose®

We have an agreement for the purchase of Kristalose API with an international supplier. We also have
manufacturing relationships with two packagers who provided finished supplies of the product for commercial and
sampling purposes during 2020.

Omeclamox-Pak®

Prior to our asset purchase agreement with GEL that closed in December 2018, GEL managed the packaging
and supply of Omeclamox-Pak commercial and sample units. Following our acquisition of the remaining rights to
the brand in late 2018, we assumed responsibility for the packaging and supply of the product. During 2019 we
entered into a new packaging arrangement for this product.

During 2020, the packager for Cumberland’s Omeclamox-Pak product encountered financial difficulties due to
the economic impact of COVID-19, and their operations suspended. Cumberland is awaiting resumption of those
operations while also exploring other alternatives to restart the product’s packaging. We informed the FDA of a
shortage of the Omeclamox-Pak effective October 14, 2020, and have not provided a date for the availability of new
inventory.

Vaprisol®

As part of the acquisition of Vaprisol, we purchased a significant existing supply of raw material inventory. In
addition, as part of that transaction, we were assigned a commercial supply agreement with the historical Vaprisol
manufacturer. In 2018, the manufacturer informed us that they would no longer be able to provide the product
following the manufacturing of one final batch which is providing us with a multi-year supply. We identified and
reached an agreement during 2020 with a new manufacturer to provide us with long term supplies of the product.
We subsequently initiated the transfer of the product’s manufacturing to the new facility in 2020.

Vibativ®

Through our acquisition of Vibativ, we acquired a multi-year supply of raw material, work in process and
finished goods inventory. As a result of the agreement, we are now responsible for the future manufacture of the
product and completed the transfer of the product’s manufacturing activities to a new supplier and received FDA
approval for that facility in 2020.

RediTrex®

In 2016, we entered into an agreement with the Nordic Group B.V. ("Nordic") to acquire the exclusive U.S.
rights to Nordic’s injectable methotrexate product line. In 2019, we received FDA approval for the product and
authorization to market them under the RediTrex brand name. Under our agreement with Nordic, they are
responsible for providing us the packaged and labeled commercial supply of RediTrex.

Distribution

Like many pharmaceutical companies, we engage a third-party with appropriate facilities and logistical
expertise to support the U.S. distribution of our products. Cardinal Health has exclusively handled our U.S. product
logistics activities, including warehousing, shipping, and various other customer activities. Our primary customers
are the wholesalers of pharmaceuticals who provide our products to hospitals, clinics and retail pharmacies in the
U.S.

CORPORATE DEVELOPMENT

Cumberland Foundation

In December 2017, we formed the Cumberland Pharma Foundation (the "Foundation") to serve as a vehicle to

facilitate the ongoing philanthropic endeavors of Cumberland Pharmaceuticals Inc.

The Foundation was formed as an independent, nonprofit corporation designed to qualify as a tax-exempt
organization pursuant to Section 501(a) of the Internal Revenue Code. The Foundation’s Board of Directors is
comprised of Cumberland Pharmaceuticals executives who are responsible for overseeing the Foundation’s ongoing
activities including charitable contributions.

During 2018, we provided a grant of 50,000 shares of our common stock to the Foundation. The shares will
address the ongoing financial needs of the Foundation, with most of the shares expected to be held for the
opportunity to realize long term appreciation to support the Foundation’s future. The Foundation maintains
independent financial statements and its contributions will not impact the financial statements of Cumberland
Pharmaceuticals. Initial annual grants by the Foundation have been and remain consistent with the historic level of
contributions made by Cumberland Pharmaceuticals. During 2020, we provided approximately $50,000 in cash
contributions to the Foundation.

Cumberland Health and Wellness Political Action Committee

In November 2017 we formed the Cumberland Health and Wellness Political Action Committee (PAC). The
objective of the PAC is to support candidates and policies that are consistent with Cumberland’s mission of
advancing patient care. The PAC’s activities will be at the local, state and federal level and conducted in a bi-
partisan manner. The initial committee membership is comprised of Cumberland Pharmaceuticals employees. The
PAC received initial funding from us and future funding will include voluntary individual contributions from
Cumberland Pharmaceuticals directors and employees.

PATENTS, TRADEMARKS AND OTHER INTELLECTUAL PROPRIETARY RIGHTS

We own the trademarks for each of our branded pharmaceutical products as well as for our corporate name and
logo. We have applied for trademark registration for other various names and logos. Over time, we intend to
maintain registrations on trademarks that remain valuable to our business.

We seek to protect our products from competition through a combination of patents, trademarks, trade secrets,
FDA exclusivity and contractual restrictions on disclosure. Proprietary rights, including patents, are an important
element of our business. We seek to protect our proprietary information by requiring our employees, consultants,
contractors and other advisors to execute agreements providing for protection of our confidential information upon
commencement of their employment or engagement. We also require confidentiality agreements from entities to
which we provide our confidential information or materials.

Acetadote®

We developed a new formulation of Acetadote (acetylcysteine) Injection as part of a Phase IV commitment in
response to a request by the FDA to evaluate the reduction of ethylene diamine tetraacetic acid ("EDTA") from the
product's formulation. In April 2012, the USPTO issued U.S. Patent number 8,148,356 (the “356 Acetadote
Patent”) which is assigned to us. The claims of the 356 Acetadote Patent encompass the new Acetadote formulation
and include composition of matter claims. Following its issuance, the 356 Acetadote Patent was listed in the FDA

Orange Book. The 356 Acetadote Patent is scheduled to expire in May 2026, which time period includes a 270-day
patent term adjustment granted by the USPTO.

Following the issuance of the 356 Acetadote Patent, we received separate Paragraph IV certification notices
from InnoPharma, Inc. ("InnoPharma"), Paddock Laboratories, LLC (“Paddock”), Mylan Institutional LLC
(“Mylan”), Sagent Agila LLC ("Sagent") and Perrigo Company ("Perrigo") challenging the 356 Acetadote Patent on
the basis of non-infringement and/or invalidity. We responded by filing five separate infringement lawsuits, in the
appropriate United States District Courts, to contest each of the challenges.

On November 12, 2012, we entered into a Settlement Agreement (the “Settlement Agreement”) with Paddock

and Perrigo to resolve the challenges and the pending litigation with those two companies.

On November 1, 2013, the United States District Courts filed opinions granting Sagent’s and InnoPharma’s
motions to dismiss our suits and we agreed not to file an appeal or motion to reconsider, thereby resolving the
challenges and the pending litigation with those two companies.

Under the Settlement Agreement, Paddock and Perrigo admit that the 356 Acetadote Patent is valid and
enforceable and that any Paddock or Perrigo generic version of Acetadote (with or without EDTA) would infringe
upon the 356 Acetadote Patent. In addition, Paddock and Perrigo will not challenge the validity, enforceability,
ownership or patentability of the 356 Acetadote Patent through its expiration currently scheduled for May 2026. On
November 12, 2012, in connection with the execution of the Settlement Agreement, we entered into a License and
Supply Agreement with Paddock and Perrigo (the “License and Supply Agreement”).

Under the terms of the License and Supply Agreement, if a third party receives final approval from the FDA for
an ANDA to sell a generic Acetadote product and such third party made such generic version available for purchase
in commercial quantities in the United States, we are to supply Perrigo with an Authorized Generic version of our
Acetadote product.

On May 18, 2012, we also submitted a Citizen Petition to the FDA requesting that the FDA refrain from
approving any applications for acetylcysteine injection that contain EDTA, based in part on the FDA's request that
we evaluate the reduction or removal of EDTA from our original Acetadote formulation.

On November 7, 2012, the FDA responded to the Citizen Petition denying our request and on November 8,
2012, we learned that the FDA approved the ANDA referencing Acetadote filed by InnoPharma, Inc. We brought
suit against the FDA contesting the FDA's decision to approve the InnoPharma generic on November 13, 2012.

On September 30, 2013, the United States District Court filed an opinion granting a summary judgment in favor

of the FDA regarding this suit.

As noted above, during 2012 the FDA approved the ANDA referencing Acetadote filed by InnoPharma, Inc.
Upon this condition, in accordance with the License and Supply agreement with Perrigo, we began to supply Perrigo
with our Authorized Generic. On January 7, 2013, Perrigo announced initial distribution of our Authorized Generic
acetylcysteine injection product.

On March 19, 2013, the USPTO issued U.S. Patent number 8,399,445 (the “445 Acetadote Patent”) which is
assigned to us. The claims of the 445 Acetadote Patent encompass the use of the 200 mg/ml Acetadote formulation
to treat patients with acetaminophen overdose. On April 8, 2013, the 445 Acetadote Patent was listed in the FDA
Orange Book. The 445 Acetadote Patent is scheduled to expire in August 2025. Following the issuance of the 445
Acetadote Patent we received separate Paragraph IV certification notices from Perrigo, Sagent Pharmaceuticals, Inc.,
and Mylan challenging the 445 Acetadote Patent on the basis of non-infringement, unenforceability and/or
invalidity.

On June 10, 2013, we became aware of a Paragraph IV certification notice from Akorn, Inc. challenging the 445
Acetadote Patent and the 356 Acetadote Patent on the basis of non-infringement. On July 12, 2013, we filed a
lawsuit for infringement of the 356 Acetadote Patent against Akorn, Inc. in United States District Court.

On February 18, 2014, the USPTO issued U.S. Patent number 8,653,061 (the “061 Acetadote Patent”) which is
assigned to us. The claims of the 061 Acetadote Patent encompass the use of the 200 mg/ml Acetadote formulation

to treat patients with acetaminophen overdose. Following its issuance, the 061 Acetadote Patent was listed in the
FDA Orange Book. The 061 Acetadote Patent is scheduled to expire in August 2025.

On May 13, 2014, the USPTO issued U.S. Patent number 8,722,738 (the “738 Acetadote Patent”) which is
assigned to us. The claims of the 738 Acetadote Patent encompass administration methods of acetylcysteine
injection, without specification of the presence or lack of EDTA in the injection. Following its issuance, the 738
Acetadote Patent was listed in the FDA Orange Book and it is scheduled to expire in April 2032.

On December 11, 2014 and March 3, 2015, we became aware of Paragraph IV certification notices from
Aurobindo Pharma Limited and Zydus Pharmaceuticals (USA) Inc., respectively, challenging the 356, 445, 061, and
738 Acetadote Patents on the basis of non-infringement.

On February 10, 2015, the USPTO issued U.S. Patent number 8,952,065 (the “065 Acetadote Patent”) which is
assigned to us. The claims of the 065 Acetadote Patent encompass the use of the 200 mg/ml Acetadote formulation
to treat patients with acute liver failure. The 065 Acetadote Patent is scheduled to expire in August 2025.

On September 30, 2015, the United States District Court for the Northern District of Illinois, Eastern Division
("District Court") ruled in our favor in our lawsuit against Mylan for infringement of the 445 Acetadote Patent. The
opinion upheld our 445 Acetadote Patent and expressly rejected Mylan's validity challenge. The District Court
ruled that Mylan is liable to us for infringement of the 445 Acetadote patent in light of Mylan's Abbreviated New
Drug Application in which Mylan sought to market a generic version of Acetadote.

On November 17, 2015, the District Court entered an order enjoining Mylan and its affiliates from selling or
using its generic version of Acetadote until August 2025, the date of expiration of the 445 Acetadote Patent. On
October 30, 2015, Mylan filed a notice of appeal to the U.S. Court of Appeals for the Federal Circuit (the "Appeals
Court").

On May 3, 2016, the USPTO issued U.S. Patent number 9,327,028 (the “028 Acetadote Patent”) which is
assigned to us. The claims of the 028 Acetadote Patent encompass administration methods of acetylcysteine
injection, without specification of the presence or lack of EDTA in the injection. Following its issuance, the 028
Acetadote Patent was listed in the FDA Orange Book and it is scheduled to expire in July 2031.

On January 26, 2017, the Appeals Court affirmed the District Court ruling in our favor in our lawsuit against
Mylan for infringement of the 445 Acetadote Patent. The Appeals Court opinion affirmed the District Court’s ruling
upholding our 445 Acetadote Patent and expressly rejected Mylan's validity challenge.

On November 3, 2017, we became aware of a Paragraph IV certification notice from Exela Pharma Sciences,

LLC challenging the 356, 445, 061, 738, and 028 Acetadote Patents on the basis of non-infringement.

We are considering our legal options and intend to continue to vigorously defend and protect our Acetadote

product and related intellectual property rights.

Caldolor®

We are the owner of U.S. Patent No. 6,727,286, which encompasses ibuprofen solution formulations, methods
of making the same, and methods of using the same, and which is scheduled to expire in November 2021. This U.S.
patent is listed in the FDA Orange Book and is associated with our completed international application No. PCT/
US01/42894. We have filed for international patent protection in association with this PCT application in various
countries, several of which have been allowed.

We have an exclusive, worldwide license to clinical data for intravenous ibuprofen from Vanderbilt University,
in consideration for royalty obligations related to Caldolor. During 2014, we obtained additional patents for the
brand. On May 27, 2014, the USPTO issued U.S. Patent number 8,735,452 (the “452 Caldolor Patent”) which is
assigned to us. The claims of the 452 Caldolor Patent encompass methods of treating pain using intravenous
ibuprofen. Following its issuance, the 452 Caldolor Patent was listed in the FDA Orange Book and is scheduled to
expire in September 2029.

On October 28, 2014, the USPTO issued U.S. Patent number 8,871,810 (the “810 Caldolor Patent”) which is
assigned to us. The claims of the 810 Caldolor Patent encompass methods of treating pain using intravenous
ibuprofen. Following its issuance, the 810 Caldolor Patent was listed in the FDA Orange Book and is scheduled to
expire in September 2029.

During the third quarter of 2015, we obtained four additional patents for Caldolor. On July 7, 2015, the USPTO
issued U.S. Patent number’s 9,072,710 (the “710 Caldolor Patent”) and 9,072,661 (the “661 Caldolor Patent”) which
are assigned to us. The claims of the 710 Caldolor Patent and the 661 Caldolor Patent include composition and
methods of treating pain, inflammation and fever using intravenous ibuprofen. These Caldolor Patents are listed in
the FDA Orange Book and are scheduled to expire in March 2032. On April 21, 2015, the USPTO issued U.S.
Patent No. 9,012,508 (the “508 Caldolor Patent”) which is assigned to us.

The claims of the 508 Caldolor Patent include methods of treating pain using intravenous ibuprofen. Following
its issuance, the 508 Caldolor Patent was listed in the FDA Orange Book and is scheduled to expire in September
2030. On August 25, 2015, the USPTO issued U.S. Patent number 9,114,068 (the “068 Caldolor Patent”) which is
assigned to us. The claims of the 068 Caldolor Patent include methods of treating pain using intravenous ibuprofen.

Following its issuance, the 068 Caldolor Patent was listed in the FDA Orange Book and is scheduled to expire
in September 2029. On September 22, 2015, the USPTO issued U.S. Patent number 9,138,404 (the “404 Caldolor
Patent”) which is assigned to us.

The claims of the 404 Caldolor Patent include methods of treating pain in critically ill patients with intravenous
ibuprofen. Following its issuance, the 404 Caldolor Patent was listed in the FDA Orange Book and is scheduled to
expire in September 2029.

On March 29, 2016, the USPTO issued U.S. Patent number 9,295,639 (the "639 Caldolor Patent") which is
assigned to us. The claims of the 639 Caldolor Patent include methods of treating pain in critically ill patients with
intravenous ibuprofen. Following its issuance, the 639 Caldolor Patent was listed in the FDA Orange Book and is
scheduled to expire in September 2029.

On May 16, 2017, the USPTO issued U.S. Patent number 9,649,284 (the "284 Caldolor Patent") which is
assigned to us. The claims of the 284 Caldolor Patent include methods of treating pain in critically ill patients with
intravenous ibuprofen. Following its issuance, the 284 Caldolor Patent was listed in the FDA Orange Book and is
scheduled to expire in September 2029. We also have additional patent applications related to Caldolor which are
pending with the USPTO.

Vaprisol®

We own numerous U.S. patents and related international patents for Vaprisol. These patents were acquired in
our February 2014 acquisition of certain product rights, intellectual property and related assets of Vaprisol from
Astellas.

Vibativ®

We own numerous U.S. patents and related international patents for Vibativ. These patents were acquired in our
November 2018 acquisition of certain product rights, intellectual property and related assets of Vibativ from
Theravance. Eleven Vibativ patents are listed in the FDA Orange Book. U.S. Patent number 7,531,623 (the “623
Vibativ Patent”) is scheduled to expire in January 2027 and includes composition of matter claims that encompass
the Vibativ drug substance as well as methods for preparing the Vibativ drug substance.

Remaining Products

We have no issued patents for our RediTrex, Omeclamox-Pak and Kristalose products. We have multiple

granted patents relating to our ifetroban products and patent applications pending with the USPTO.

COMPETITION

The pharmaceutical industry is characterized by intense competition and rapid innovation. Our continued
success in developing and commercializing pharmaceutical products will depend, in part, upon our ability to
compete against existing and future products in our target markets. Competitive factors directly affecting our
markets include but are not limited to:

•

product attributes such as efficacy, safety, ease-of-use and cost-effectiveness;

brand awareness and recognition driven by sales, marketing and distribution capabilities;

intellectual property and other exclusivity rights;

availability of resources to build and maintain developmental and commercial capabilities;

successful business development activities;

extent of third-party reimbursements, insurance coverage; and

establishment of advantageous collaborations to conduct development, manufacturing or commercialization
efforts.

A number of our competitors possess research and development and sales and marketing capabilities as well as
financial resources greater than ours. These competitors, in addition to emerging companies and academic research
institutions, may be developing, or in the future could develop, new technologies that could compete with our
current and future products or render our products obsolete.

Our products face competition from other branded products, generics, and alternate medical treatments. Our
task is to position each brand to feature its competitive advantages, implement a well thought out marketing plan and
provide focused sales and other tactical support.

Acetadote®

Acetadote is our injectable formulation of N-acetylcysteine ("NAC") for the treatment of acetaminophen
overdose. NAC is accepted worldwide as the standard of care for acetaminophen overdose. Our competitors in the
acetaminophen overdose market are those companies selling orally administered NAC including, but not limited to,
Geneva Pharmaceuticals, Inc., Bedford Laboratories division of Hikma Pharmaceuticals, Roxane Laboratories, Inc.,
InnoPharma Inc. and Hospira Inc.

In November 2012, InnoPharma Inc. was granted approval by the FDA to distribute their generic form of the
old formulation of Acetadote containing EDTA. In late 2012, we entered into the Settlement Agreement with
Paddock and Perrigo that included the right to distribute our Authorized Generic Acetadote injection product. Our
branded Acetadote now competes with both the EDTA free Authorized Generic Acetadote distributed by Paddock
and Perrigo along with generic Acetadote products that contain EDTA.

Manufactures of the old Acetadote formulation include: Akorn, AuroMedics Pharma, Fresenius Kabi and

Sagent Pharmaceuticals.

Caldolor®

Caldolor is marketed for the treatment of pain and fever, primarily in a hospital or surgery center setting. A

variety of other products address the acute pain market:

• Morphine, the most commonly used product for the treatment of acute, post-operative pain, is

manufactured and distributed by several generic pharmaceutical companies;

•

Other generic injectable opioids, including fentanyl, meperidine and hydromorphone, address this
market;

•

Ketorolac tromethamine (brand name Toradol®), an injectable NSAID, is also manufactured and
distributed by several generic pharmaceutical companies;

IV acetaminophen (brand name Ofirmev®), an injectable analgesic product is sold by Mallinckrodt plc,
and there are also generic versions from different manufacturers available;

Bupivacaine injectable suspension (brand name Exparel®), product sold by Pacira Pharmaceuticals,
Inc., two additional bupivacaine products, Xaracoll and Posimir, were recently approved; and

IV meloxicam (brand name Anjeso™), a once a day injectable COX-2 preferential NSAID
manufactured by Baudax Bio which was recently approved by the FDA.

We are aware of other product candidates in development to treat acute pain including injectable NSAIDs,
novel opioids, new formulations of existing therapies and extended release anesthetics. We believe non-narcotic
analgesics for the treatment of post-surgical pain are the primary potential competitors to Caldolor.

In addition to the injectable analgesic products above, many companies are developing analgesics for specific
indications such as migraine and neuropathic pain, oral extended-release forms of existing narcotic and non-narcotic
products, and products with new methods of delivery such as transdermal. We are not aware of any approved
injectable products indicated for the treatment of fever in the U.S. other than Caldolor and Ofirmev.

There are, however, numerous drugs available to physicians to reduce fevers in hospital settings via oral
administration to the patient, including ibuprofen, acetaminophen, and aspirin. These drugs are manufactured by
numerous pharmaceutical companies.

Kristalose®

Kristalose is a dry powder crystalline prescription formulation of lactulose indicated for the treatment of
constipation. The U.S. constipation therapy market includes various prescription and over the counter, or OTC,
products. The branded prescription products which we believe are our primary competitors are:

•

Lubiproston (brand name Amitiza®), an oral product indicated for the treatment of chronic idiopathic
constipation, irritable bowel syndrome with constipation in adults, is manufactured and sold by
Mallinckrodt Pharmaceuticals.

• Naloxegol (brand name Movantik®), an oral product indicated for the treatment of opioid-induced
constipation in adults with chronic non-cancer pain and recently acquired by RedHill Biopharma in the first
quarter of 2020.

•

Linaclotide (brand name Linzess®), an oral product indicated for the treatment of irritable bowel syndrome
with constipation and chronic idiopathic constipation. It is sold by Allergan, Inc. and Ironwood
Pharmaceuticals, Inc.

Plecanatide (brand name Trulance®), an oral product indicated for the treatment of irritable bowel
syndrome with constipation and chronic idiopathic constipation. It is sold by Synergy Pharmaceuticals.

• Generic and branded liquid lactulose products are marketed by a number of pharmaceutical companies.

•

Lactitol for oral solution (brand name Pizensy), an oral, osmotic laxative indicated for the treatment of
chronic idiopathic constipation and distributed by Braintree Laboratories, Inc. was recently approved by
the FDA.

There are several hundred OTC products used to treat constipation marketed by numerous pharmaceutical and
consumer health companies. MiraLax (polyethylene glycol 3350), previously a prescription product, was indicated
for the treatment of constipation and manufactured and marketed by Bayer. MiraLax was converted to an OTC

product in February 2007 and recently, the FDA rescinded the approval of the generic prescription polyethylene
glycol 3350 products.

Omeclamox®-Pak

Omeclamox-Pak is a branded prescription product used for the treatment of Helicobacter pylori (H. pylori)
infection and duodenal ulcer disease. It combines three well-known and widely prescribed medications packaged in
a daily dose pack for patient convenience: omeprazole, clarithromycin, and amoxicillin. The three individual
components of Omeclamox-Pak are also available from other suppliers through three separate prescriptions.

While there are several competitor products, Omeclamox-Pak is one of the two actively marketed products for
this condition. In addition, compared to the competing products, Omeclamox-Pak has the lowest pill burden, fewest
days of therapy and convenient twice daily dosing. The prescription combination products, indicated for treatment of
H. pylori, which we believe are our primary competitors are:

•

PrevPac®, an oral product sold by Takeda Pharmaceutical Company. There are also approved generic
versions of PrevPac;

Pylera®, an oral product manufactured and sold by Allergan plc; and

Talicia®, an oral product manufactured by RedHill Biopharma which was recently approved by the FDA.

Vaprisol®

Vaprisol is a patented, prescription brand indicated to raise serum sodium levels in hospitalized patients with
euvolemic and hypervolemic hyponatremia. The product was developed and registered by Astellas and then
launched in 2006. It is one of two branded prescription products indicated for the treatment of hyponatremia, and the
first and only intravenously administered branded treatment. The other competing product is Samsca, an oral
product sold by Otsuka Pharmaceutical Company.

Vibativ®

Effective November 12, 2018, Cumberland acquired the worldwide rights to Vibativ (telavancin) from

Theravance Biopharma.

Vibativ is a potent, once-daily, injectable antibiotic for the treatment of certain gram-positive infections. Vibativ
is approved for the treatment of complicated skin and skin structure infections and hospital-acquired or ventilator-
associated bacterial pneumonia caused by susceptible isolates of Staphylococcus aureus when alternative treatments
are not suitable. There are several generic and branded antibiotics that compete for these indications.

The major generic competitors are vancomycin, linezolid, and daptomycin. Vancomycin is by far the most

widely used agent. Newer branded agents are also available including:

•

Ceftaroline fosamil (brand name Teflaro® ) an injectable antibiotic manufactured and sold by Allergan

• Dalbavancin (brand name Dalvance® ), an injectable antibiotic manufactured and sold by Allergan

• Oritavancin (brand name Orbactiv® ), an injectable antibiotic manufactured and sold by Melinta

We are aware of a number of other novel antibiotics which are currently in development.

Antibiotic drug selection is based both on an empiric and susceptibility proven basis. In the hospital setting, cost
is an important factor which favors the use of generic agents as long as they are effective. Newer agents are often
reserved for two reasons: they are valuable in the treatment of patients that fail to respond to generics and it is
considered good practice to conserve the use of these agents to reduce the risk of resistance.

RediTrex®

RediTrex was introduced by Cumberland in the fourth quarter of 2020. RediTrex is methotrexate for
subcutaneous administration in a unique syringe designed for ease of use, improved accuracy, and enhanced safety.
It is indicated for treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and severe, recalcitrant,
or disabling psoriasis unresponsive to alternative treatments.

This market is highly competitive with drugs from several different therapeutic classes available for treatment.
Methotrexate is considered a standard of care especially when patients fail to respond adequately to low dose
steroids or non-steroidal anti-inflammatory drugs (NSAIDs). Methotrexate is available in multiple dose forms
including oral, subcutaneous, and intra-venous. Methotrexate may be used alone or in combination with drugs from
other therapeutic classes to adequately control patient symptoms.

RediTrex competes with other dose forms and delivery systems for methotrexate including, oral tablets,
conventional vial and syringe administration, and auto-injector pens. Oral tablets and conventional vials are generic
and available from many suppliers. There are two auto-injector pen products available, Rasuvo and Otrexup.

RediTrex also competes with or may be used in combination with drugs from other therapeutic classes
including, injectable biologics like Humira and Enbrel and oral JAK inhibitors like Xaljanz. These newer agents are
more expensive than the methotrexate products but benefit from significant promotion to patients and doctors.

GOVERNMENT REGULATION

The development of new pharmaceutical products can be a long, expensive and risky process. There is no
assurance we will obtain successful study results or secure the needed market approvals for our pipeline product
candidates. Governmental authorities in the U.S. and other countries extensively regulate the research,
development, testing, manufacturing, distribution, marketing and sale of pharmaceutical products. In the U.S., the
FDA under the Federal Food, Drug, and Cosmetic Act, ("FDCA"), the Public Health Service Act, and other federal
statutes and regulations, subjects pharmaceutical products to rigorous review. Failure to comply with applicable
U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to
approve pending New Drug Application ("NDAs") or biologics license applications, ("BLAs"), warning letters,
product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil
penalties, and criminal prosecution.

We, our manufacturers and contract research organizations may also be subject to regulations under other
federal, state and local laws, including the Occupational Safety and Health Act, (OSHA), the Resource Conservation
and Recovery Act, the Clean Air Act and import, export and customs regulations as well as the laws and regulations
of other countries.

FDA Approval Process

The FDA is a regulatory agency within the Department of Health and Human Services. A key responsibility is
to regulate the safety and effectiveness of drugs sold in the United States. The FDA manages this responsibility into
two phases: pre-approval (premarket) and post approval (post market). The FDA reviews manufacturers'
applications to market drugs in the United States; a drug may not be sold unless it has FDA approval. The FDA
continues its oversight of drug safety and effectiveness as long as the drug is on the market.

To market a prescription drug in the United States, a manufacturer needs FDA approval. To get that approval,
the manufacturer must demonstrate the drug's safety and effectiveness according to criteria specified in law and
agency regulations, ensure that its manufacturing plant passes FDA inspection, and obtain FDA approval for the
drug's labeling, a term that includes all written material about the drug, including, for example, packaging,
prescribing information for physicians and patient brochures.

The progression to drug approval begins before FDA involvement. First, scientists work in the laboratory to
discover and develop a new compound. Next, basic questions on safety are answered by nonclinical testing with

animals and then, a drug or biotechnology company develops a prototype drug. That company must seek clearance
from the FDA by way of an Investigational New Drug ("IND") application to test the product with human subjects.

Those tests, called clinical trials, are carried out sequentially in Phase I, II, and III studies, which involve
increasing numbers of subjects. The manufacturer then compiles the resulting data and analyses in an NDA. The
FDA reviews the NDA with three major concerns: (1) safety and effectiveness in the drug's proposed use; (2)
appropriateness of the proposed labeling; and (3) adequacy of manufacturing methods to assure the drug's identity,
strength, quality, and purity.

The FDCA and associated regulations detail the requirements at each step. The FDA uses a few special
mechanisms to expedite drug development and the review process when a drug might address an unmet need or a
serious disease or condition. Those mechanisms include accelerated approval, fast track and priority reviews and the
newer designation, breakthrough therapy.

The sponsor of the drug typically conducts human clinical trials in three sequential phases, but the phases may
overlap. Phase I clinical trials are generally conducted in a small number of healthy volunteers, primarily to collect
and assess pharmacokinetics and safety data at one or more dosages prior to proceeding into patients.

In Phase II clinical trials, the sponsor evaluates the early efficacy of the product in short term trials on the

targeted indication and identifies possible adverse effects and safety risks in a patient population.

Phase III clinical trials typically involve testing for patients in long term trials examining safety and clinical

efficacy in an expanded population at geographically-dispersed test sites.

The FDA requires that clinical trials be conducted in accordance with the FDA's Good Clinical Practice GCP
requirements. The FDA may order the partial, temporary or permanent discontinuation of a clinical trial at any time
or impose other sanctions if it believes that the clinical trial is not being conducted in accordance with FDA
requirements or presents an unacceptable risk to the clinical trial patients. The institutional review board ("IRB"), or
ethics committee (outside of the U.S.), of each clinical site generally must approve the clinical trial design and
patient informed consent and may also require the clinical trial at that site to be halted, either temporarily or
permanently, for failure to comply with the IRB's requirements, or may impose other conditions.

The results of the nonclinical and clinical trials, together with detailed information on the manufacturing and
composition of the product and proposed labeling, are submitted to the FDA in the form of an NDA for marketing
approval. The NDA undergoes a 60-day validation review period before it is accepted for filing.

If the NDA is found to be incomplete, it will not be accepted. Once the NDA is validated and accepted for

filing, the FDA begins an in-depth review of the NDA.

Under policies agreed to by the FDA under the Prescription Drug User Fee Act, or PDUFA (currently PDUFA
VI - effective October 1, 2017), the FDA has a target timeline of 10 months in which to complete its initial review of
a standard NDA and respond to the applicant. The review process and the PDUFA goal date may be extended by
two months to address deficiencies, or by three months if the FDA requests or the NDA sponsor otherwise provides
additional information or clarification regarding information already provided in the submission at any time during
the review clock period. If the FDA's evaluations of the NDA and the clinical and manufacturing procedures and
facilities are favorable and meet all regulations, the FDA will issue an approval letter. Priority review is reserved for
drugs that represent a “significant improvement in safety or efficacy” over existing treatments and FDA endeavors
to complete these reviews in six months.

If the NDA meets with FDA approval, a letter will be sent out indicating approval and final labeling
recommendations. If not, a complete response letter will be sent to applicants indicating that the review cycle for an
application is complete and that the application is not ready for approval.

The complete response letter will describe the specific deficiencies that the agency has identified in an
application and what changes must be made before the application can be approved, with no implication regarding
whether the application will ultimately be approved. An approval letter authorizes commercial marketing of the
drug for the proposed indication(s) under study. FDA reported that NDAs showed a steadier increase with the

percentage of first-cycle approval letters for new molecular entities rising from 56% for FY 2009 applications to
89% for FY 2018 applications.

The time and cost of completing these steps and obtaining FDA approval can vary dramatically depending on

the drug. However, to complete these steps for a novel drug can take many years and cost millions of dollars.

Section 505(b) New Drug Applications

An NDA may be submitted under different methods, a 505(b)(1), 505(b)(2) or 505(j). Section 505(b) provides
for the submission of an NDA to support the approval of a drug. Upon approval, a drug may be marketed only for
the FDA-approved indication(s) in the approved dosage form. Further clinical trials may be necessary to gain
approval for the use of the product for any additional indications or dosage forms.

The FDA also requires post market safety surveillance reporting to monitor the side effects of the drug, which

may result in withdrawal of approval after marketing begins if significant adverse safety findings are found.

Section 505(b)(1) or the 'full' NDA is used for new chemical entities ("NCEs") and requires full clinical and
nonclinical development of a compound. Marketing exclusivity assigned to a 505(b)(1) approval is five years. A
505(b)(2) NDA permits the submission of an NDA where at least some of the information required for approval
comes from studies not conducted by or for the applicant using previously reported safety and efficacy data, and for
which the applicant has not obtained a right of reference. Generally new studies are required to provide data on the
proposed change.

Some examples of products that may be allowed to follow a 505(b)(2) path to approval are drugs which have a
new dosage form, strength, route of administration, formulation or indication or combination drugs. Marketing
exclusivity for a 505(b)(2) submission is three years.

Both 505 (b)(1) and (b)(2) are eligible for seven years of exclusivity for orphan drugs and/or six months for
pediatric exclusivity. Any marketing exclusivity is independent of patent exclusivity. We successfully secured FDA
approvals for Acetadote in January 2004, for Caldolor in June 2009 and for RediTrex in 2019 pursuant to the
505(b)(2) pathway.

Orphan drug designation

The Orphan Drug Act of 1983 (the "Orphan Drug Act") encourages manufacturers to seek approval of products
intended to treat “rare diseases and conditions” with a prevalence of fewer than 200,000 patients in the U.S. or for
which there is no reasonable expectation of recovering the development costs for the product. For products that
receive orphan drug designation by the FDA, the Orphan Drug Act provides tax credits for clinical research, FDA
assistance with protocol design, eligibility for FDA grants to fund clinical studies, waiver of the FDA application
fee, and a period of seven years of marketing exclusivity for the product following FDA marketing approval.

Acetadote received Orphan Drug designation in October 2001 and in 2004 the FDA approved the product to
prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen. Acetadote
was entitled to marketing exclusivity until January 2011 for the treatment of this approved indication.

Section 505(j) abbreviated new drug applications

An ANDA is a type of NDA where approval of a generic drug is based on demonstrating comparability to an
innovator drug product (the RLD or Reference Listed Drug). Applications are "abbreviated" because they generally
don't include preclinical and clinical data to establish safety and effectiveness. Generics must demonstrate that the
product is bioequivalent (i.e., performs in the same manner and is comparable to the 'innovator' product in active
ingredient, dosage form, strength, route of administration, labeling, quality, performance characteristics and intended
use).

Abbreviated applications may be submitted for drug products that are the same as a listed drug and must be
identical in active ingredient(s), form, strength, route of administration, and identical in conditions of use (non-
exclusive uses). Products are declared suitable based on a suitability petition to the FDA. If the petition is approved,
the Sponsor may then submit the ANDA.

The Hatch-Waxman Act

The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act",

is a 1984 United States federal law which established the modern system of generic drugs.

Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. Section 505(j) 21 U.S.C. 355(j) sets forth
the process by which would-be marketers of generic drugs can file ANDAs to seek FDA approval of the generic.
Section 505(j)(2)(A)(vii)(IV), the so-called Paragraph IV, allows 180-day exclusivity to companies that are the
"first-to-file" an ANDA against holders of patents for branded counterparts.

These Hatch-Waxman amendments grant generic manufacturers the ability to mount a validity challenge
without incurring the cost of entry or risking enormous damages flowing from any possible infringement. Hatch-
Waxman essentially redistributes the relative risk assessments and explains the flow of settlement funds and their
magnitude. Hatch-Waxman gives generics considerable leverage in patent litigation.

Health care legislation

On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act, or
PPACA. On March 30, 2010, the Health Care and Education Reconciliation Act of 2010, or HCERA, was enacted
into law, which modified the revenue provisions of the PPACA. The PPACA as amended by the HCERA constitutes
the healthcare reform legislation. The following highlights certain provisions of the legislation that may affect us.

Pharmaceutical Industry Fee: Beginning in calendar-year 2011, an annual fee was imposed on pharmaceutical
manufacturers and importers that sell branded prescription drugs to specified government programs (e.g., Medicare
Part D, Medicare Part B, Medicaid, Department of Veterans Affairs programs, Department of Defense programs and
TRICARE).

The annual fee is allocated to companies based on their previous calendar-year market share using sales data
that the government agencies that purchase the pharmaceuticals will provide to the Treasury Department. Although
we participate in governmental programs that subject us to this fee, our sales volume in such programs is less than
$10 million, with the first $5 million of sales being exempt from the fee. This fee has not had a material impact and
is not expected to have a material impact on our results of operations.

Physician Payments Sunshine Act: The PPACA also includes provisions known as the Physician Payments
Sunshine Act, or Sunshine Act, which require manufacturers of pharmaceuticals and medical devices covered under
Medicare and Medicaid to record any transfers of value to physicians and teaching hospitals and to report this data
to the Centers for Medicare and Medicaid Services, or CMS, for aggregation and subsequent public disclosure.
Under the Sunshine Act, beginning August 1, 2013, we have collected data regarding reportable transfers of value
and have reported such data to CMS. Failure to report appropriate data may result in civil or criminal fines and/or
penalties. In addition to the Federal Sunshine Act, similar reporting requirements have also been enacted on the
state level requiring transparency of interactions with health care professionals.

Medicaid Rebate Rate: We currently provide rebates for products sold to Medicaid beneficiaries.

Product Serialization: In November of 2013, the FDA passed the Drug Supply Chain Security Act (DSCSA).
The DSCSA was created to strengthen the security of the drug distribution supply chain by adding controls such as a
national pharmaceutical track and trace system and establishing national standards for licensing of prescription drug
wholesale distributors and
including
manufacturers, repackagers, wholesale distributors and dispensers to provide transaction information to subsequent
purchasers for certain prescription drugs. We have taken necessary steps to implement this program and are in
compliance with all requirements by the November 2018 deadline.

logistics providers. DSCSA requires

trading partners,

third-party

21st Century Cures Act: The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is
designed to help accelerate medical product development and bring new innovations and advances to patients who
need them faster and more efficiently. The law builds on FDA's ongoing work to incorporate the perspectives of
patients into the development of drugs, biological products, and devices in FDA's decision-making process. The

Cures Act enhances FDA's ability to modernize clinical trial designs and clinical outcome assessments, which will
speed the development and review of novel medical products, including medical countermeasures.

Specifically, the Cures Act enables us to work with FDA in the development of new biomarkers, clinical
outcome assessments, surrogate endpoints, and patient reported outcomes. It allows for the use of data summaries
rather than full clinical trials for approval and the use of real world evidence to support approval of new indications
of approved medical products, or to help satisfy post-approval study requirements for marketed products.

Post Approval Activities

Once a drug is on the U.S. market (following FDA approval of the NDA), the FDA continues to address drug
production, distribution, and use. FDA activities are based on ensuring drug safety and effectiveness, and address
product integrity, labeling, reporting of research and adverse events, surveillance, drug studies, risk management,
information dissemination, off-label use, physician advertising and direct-to-consumer advertising.

If we amend the NDA for an FDA approved product, such as adding safety or efficacy labeling claims,
promoting those new claims, making certain manufacturing changes or product enhancements, we will need FDA
review and approval before the change can be implemented. While physicians may use products for indications that
have not been approved by the FDA, we may not label or promote the product for an indication that has not been
approved.

Securing FDA approval for new indications, product enhancements, and manufacturing and labeling changes
may require us to conduct additional clinical trials under FDA's IND regulations. Even if such studies are conducted,
they are still subject to the same requirements and timelines as an original NDA.

The FDA continuously gathers information about possible adverse reactions to the products it has approved for
use. The FDA requires all manufacturers to report adverse events. It also provides a procedure for consumers and
physicians to voluntarily report their concerns about drugs. The agency collects those reports through MedWatch
and uses its FDA Adverse Event Reporting System (FAERS) to store and analyze them. Because some events may
occur after the use of a drug for reasons unrelated to the product, the FDA reviews the events to assess which ones
may indicate a problem with that particular drug.

They then use information gleaned from the surveillance data to determine a course of action. They might
recommend a change in drug labeling to alert users to a potential problem, or, perhaps, to require the manufacturer
to study the observed association between the drug and the adverse event.

In addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal
laws have been applied to restrict certain marketing practices in the pharmaceutical industry in recent years. These
laws include anti-kickback statutes and false claims statutes.

The federal health care program anti-kickback statute prohibits, among other things, knowingly and willfully
offering, paying, soliciting or receiving remuneration to induce or in return for purchasing, leasing, ordering or
arranging for the purchase, lease or order of any health care item or service reimbursable under Medicare, Medicaid
or other federally financed health care programs. This statute has been interpreted to apply to arrangements between
pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other.
Violations of the anti-kickback statute are punishable by imprisonment, criminal fines, civil monetary penalties and
exclusion from participation in federal health care programs.

Federal False Claims Act

The 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
have a false claim paid.

A number of pharmaceutical and other health care companies have been prosecuted under these laws for
allegedly inflating drug prices they report to pricing services, which in turn were used by the government to set
Medicare and Medicaid reimbursement rates, and for allegedly providing free product to customers with the
expectation that the customers would bill federal programs for the product.

ICH - International Committee on Harmonization

Outside of the U.S., our ability to market our products will depend on receiving marketing authorizations from
the appropriate regulatory authorities. The International Committee on Harmonization (ICH) provides a set of
standards that most Regulatory Authorities adhere to (e.g. U.S., Europe, and Japan) allowing greater harmonization
in the interpretation and application of technical guidelines and requirements for pharmaceutical product
registration, thereby reducing or obviating duplication of testing carried out during the research and development of
new human medicines. Regulatory harmonization offers many direct benefits to both regulatory authorities and the
pharmaceutical industry with beneficial impact for the protection of public health.

ENVIRONMENTAL MATTERS

We are subject to federal, state and local environmental laws and regulations and we believe that our operations
comply with such regulations. We anticipate that the effects of compliance with federal, state and local laws and
regulations relating to the discharge of materials into the environment will not have any material effect on our
capital expenditures, earnings or competitive position.

SEASONALITY

There are no significant seasonal aspects to our business.

BACKLOG

Due to the relatively short lead-time required to fill orders for our products, backlog of orders is not considered

material to our business.

EMPLOYEES

As of December 31, 2020, we had 90 employees. We believe that our future will depend in part on our
continued ability to attract, hire, and retain qualified personnel, including hospital and field sales personnel in
particular.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

We make statements in this Annual Report on Form 10-K that are “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. All statements other than statement of historical facts may be forward-looking statements. In
particular, forward-looking statements include, among other things, statements regarding our intent, belief or
expectations, and can be identified by the use of terminology such as “may,” “will,” “expect,” “believe,” “intend,”
“plan,” “estimate,” “should,” “seek,” “anticipate” and other comparable terms or the negative thereof. In addition,
we, through our senior management, from time to time make forward-looking oral and written public statements
concerning our expected future operations and other developments. While forward-looking statements reflect our
good-faith beliefs and best judgment based upon current information, they are not guarantees of future performance
and are subject to known and unknown risks and uncertainties, including those mentioned in Item 1A, “Risk
Factors,” Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and
elsewhere in this Form 10-K. Accordingly, investors are cautioned not to place undue reliance on any forward-
looking statements. Actual results may differ materially from the expectations contained in the forward-looking
statements as a result of various factors. Such factors include, but are not limited to:

•

The possible or assumed future results of operations, including the accuracy of our estimates regarding
expenses, future revenues, capital requirements and needs for additional financing;

Changes in national or regional economic conditions, including changes in interest rates and the
availability and the cost of capital to us;

The extent of the impact of the COVID-19 pandemic, including the duration and any recurrence of the
COVID-19 pandemic, the duration and scope of related government orders and restrictions, the impact
on our employees, and the extent of the impact of the COVID-19 pandemic on overall demand for our
key products;

The impact of the COVID-19 pandemic on our suppliers, including any disruptions and inefficiencies
in the supply chain for our products;

Our competitive position and competitors, including the size and growth potential of the markets for
our products and product candidates;

The success, cost and timing of our product acquisition and development activities and clinical trials;
and our ability to successfully commercialize our product candidates;

Product efficacy or safety concerns, whether or not based on scientific evidence, resulting in product
withdrawals, recalls, regulatory action on the part of the FDA (or international counterparts) or
declining sales;

The performance of our third-party suppliers and manufacturers which impacts our supply chain and
could create business shutdowns or product shortages; and the retention of key scientific and
management personnel;

Challenges to our patents and the introduction of generic versions of our products and product
candidates, which could negatively impact our ability to commercialize and sell our products and
product candidates and decrease sales a result of market exclusivity;

Changes in reimbursement available to us, including changes in Medicare and Medicaid payment
levels and availability of third-party insurance coverage and the effects of future legislation or
regulations, including changes to regulatory approval of new products, licensing and patent rights,
environmental protection and possible drug re-importation legislation;

Interruptions and breaches of our computer and communications systems, and those of our vendors,
including computer viruses, hacking and cyber-attacks, that could impair our ability to conduct
business and communicate internally and with our customers, or result in the theft of trade secrets or

other misappropriation of assets, or otherwise compromise privacy of sensitive information belonging
to us, our customers or other business partners; and

•

Issuance of new or revised accounting standards by the Financial Accounting Standards Board and the
Securities and Exchange Commission.

The list above contains many, but not all, of the factors that could impact our ability to achieve results
described in any forward-looking statements. Investors should understand that it is not possible to predict or identify
all such factors and should not consider this list to be a complete statement of all potential risks and uncertainties.

Item 1A. Risk Factors.

Risk Factor Summary

Investing in our common stock involves a high degree of risk. You should carefully consider all information in
this Annual Report on Form 10-K prior to investing in our common stock. These risks are discussed more fully in
the section titled “Risk Factors.” These risks and uncertainties include, but are not limited to, the following:

• General economic conditions can have a material adverse effect on our business, financial conditions and

•

result of operations.
The ongoing COVID-19 pandemic may adversely affect our revenues, results of operations and financial
condition.
Failure to implement strategies to enhance our performance could have a material adverse effect on our
business, results of operations and financial conditions.

• Our ability to perform depends on keeping and hiring exceptionally talented management and employees,
and our failure to do so could have a material adverse effect on our business, revenues, results of operations
and financial condition.

• Our success depends, in part, on our ability to successfully obtain or retain high-performing third-party
performers on commercially acceptable terms, and the failure to do so can have a material adverse effect on
our business, financial conditions and results of operations.

• Our business is subject to stringent government regulations, it must adhere to numerous complex pieces of

legislation, and all of our products face regulatory challenges.

• Our business depends on the successful protection of our intellectual property rights and our product
candidates becoming approved by regulatory agencies, commercially viable, and accepted by the market.
• Our business faces a serious financial risk if generic products that compete with any of our branded
pharmaceutical products are approved and sold because sales of our products will be adversely-affected and
our business may not recover the capital costs of bringing that product to market.

• Our business faces an inherent risk of product liability lawsuits related to the testing of our product
candidates and the commercial sale of our products, and if we cannot successfully defend ourselves against
the product liability claim, we may incur substantial liabilities.

• We may attempt to develop internationally and license our products globally, as well as invest in other
businesses or joint ventures, all of which may be unsuccessful, divert our management’s attention and harm
our operating results and prospects.

The risk factors described below and throughout this report should be carefully considered and could materially
affect our business. There are also risks that are not presently known or not presently material, as well as the other
information set forth in this report that could materially affect our business. In addition, in our periodic filings with
the SEC, press releases and other statements, we discuss estimates and projections regarding our future performance
and business outlook. By their nature, such “forward-looking statements” involve known and unknown risks,
uncertainties and other factors that in some cases are out of our control. For a further discussion of forward-looking
statements, please refer to the section entitled “Special Note Regarding Forward-Looking Statements.” These factors
could cause our actual results to differ materially from our historical results or our present expectations and
projections. These risk factors and uncertainties include, but are not limited to the following:

RISKS RELATED TO OUR BUSINESS

Our business could be adversely affected by natural disasters, public health epidemics, and other events beyond
our control.

Our business has been adversely impacted by the recent coronavirus (“COVID-19”) outbreak which has
affected more than 200 countries and has significantly disrupted the day-to-day activities of both individuals and
companies. For example, we have been following the recommendations of health authorities to minimize exposure
risk for our employees since March 2020, including allowing employees to work remotely to the extent possible.
This has included our home office employees and our hospital and field based sales representatives. We rely on
individuals and third-party organizations around the world to supply components, manufacture and distribute our
products and execute our clinical trials. We are aware of a few instances where these individuals and third-party
organizations were adversely impacted by the COVID-19 pandemic. We may experience revenue loss, supply
interruptions, time delays and incur unplanned expenses as a result of the impact of the ongoing COVID-19
pandemic.

The COVID-19 pandemic’s impact on global markets could affect our future access to liquidity and materially
adversely affect our results of operations and financial condition.

The coronavirus has spread throughout much of the world after initially surfacing in Wuhan, China in December
2019. State and local authorities in the United States, like their counterparts in many other countries, have since
forced many businesses to temporarily shut down in an attempt to slow the spread of the virus, and Americans are
being told by public officials to practice “social distancing.” Global stock markets have reacted very negatively, and
economists are projecting a sharp economic slowdown, at least in the near term, even as governments take
emergency relief measures. While the economic impact brought by, and the duration of, COVID-19 is difficult to
assess or predict, the COVID-19 pandemic could result in significant disruption of global financial markets,
reducing our ability to access capital in the future, which could negatively affect our liquidity in the future. The
situation is constantly evolving, however, so the extent to which the COVID-19 outbreak will impact businesses and
the economy is highly uncertain and cannot be predicted. Accordingly, we cannot predict the extent to which our
results of operations, financial condition and cash flows will be affected.

An adverse development regarding our products could have a material and adverse impact on our future
revenues and profitability.

A number of factors may impact the effectiveness of our marketing and sales activities and the demand for our

products, including:

•

Changes in intellectual property protection available for our products or competing treatments;

Any unfavorable publicity concerning us, our products, or the markets for these products such as
information concerning product contamination or other safety issues in any of our product markets,
whether or not directly involving our products;

Perception by physicians and other members of the healthcare community of the safety or efficacy of
our products or competing products;

Regulatory developments related to our marketing and promotional practices or the manufacture or
continued use of our products;

The prices of our products relative to other drugs or competing treatments;

The impact of current or additional generic competitors;

The availability and level of third-party reimbursement for sales of our products; and

The continued availability of adequate supplies of our products to meet demand.

If demand for our products weaken, our revenues and profitability will likely decline. Known adverse effects of
our marketed products are documented in product labeling, including the product package inserts, medical
information disclosed to medical professionals and all marketing-related materials. At this time, no unforeseen or
serious adverse effects outside of those specified in current product labeling have been directly attributed to our
approved products.

We currently market and sell seven products: Acetadote, Caldolor, Kristalose, Vaprisol, Omeclamox-Pak, and
Vibativ with RediTrex being marketed since late 2020. A product contamination or other safety or regulatory issues,
such as a failure to meet certain FDA reporting requirements involving our products could negatively impact us and
possibly lead to a product recall. In addition, changes impacting any of our products in areas such as competition,
lack of market acceptance or demand, government regulation, intellectual property, reimbursement and
manufacturing could have an adverse impact on our future revenues and profitability.

The FDA has requested prescribers and manufacturers of prescription combination products that contain
acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule.
The FDA requested this action to protect consumers from the risk of severe liver damage which can result from
excess acetaminophen. This category of prescription drugs combines acetaminophen with another ingredient
intended to treat pain (most often an opioid), and these products are commonly prescribed to consumers for pain,
such as pain from acute injuries, post-operative pain, or pain following dental procedures.

The FDA also requires manufacturers to appropriately label all prescription combination acetaminophen
products to warn of the potential risk for severe liver injury. The actions the FDA is taking for prescription
acetaminophen combination products do not affect over-the-counter acetaminophen products. The FDA's regulation
of acetaminophen in prescription combination products and over-the-counter products may reduce the number of
acetaminophen overdoses which could result in a lower demand for Acetadote. If the demand for Acetadote
decreases, it could have an adverse impact on our future revenues and profitability.

The commercial success of Caldolor is dependent on many third-parties, including physicians, pharmacists,
hospital pharmacy and therapeutics committees, or P&T committees, suppliers and distributors, all of whom we
have little or no control over. We expect Caldolor to continue to be administered primarily to hospital and surgery
center patients who are unable to receive oral therapies for the treatment of pain or fever. Before we can distribute
Caldolor to any new hospital customers, Caldolor must be approved for addition to the hospitals’ formulary lists by
their P&T committees. A hospital’s P&T committee generally governs all matters pertaining to the use of
medications within the institution, including review of medication formulary data and recommendations of drugs to
the medical staff. We cannot guarantee that we will be successful in getting the approvals we need from enough
P&T committees to be able to optimize hospital sales of Caldolor. Even if we obtain hospital approval for Caldolor,
we must still convince individual hospital physicians to prescribe Caldolor repeatedly. The commercial success of
Caldolor also depends on our ability to coordinate supply, distribution, marketing, sales and education efforts. As
with our other products, if Caldolor is not accepted in the marketplace, it could have an adverse impact on our future
revenues and profitability.

If any manufacturer or partner we rely upon fails to supply our products in the amounts we require on a timely
basis, or fails to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may be
unable to meet demand for our products and may lose potential revenues.

We do not manufacture any of our products, and we do not currently plan to develop any capacity to do so. Our
dependence upon third parties for the manufacture of our products could adversely affect our profit margins or our
ability to develop and deliver products on a timely and competitive basis. If for any reason we are unable to obtain
or retain third-party manufacturers on commercially acceptable terms, we may not be able to sell our products as
planned. Furthermore, if we encounter delays or difficulties with contract manufacturers in producing our products,
the distribution, marketing and subsequent sales of these products could be adversely affected. A long-term inability
to meet demand for our products could result in impairment of our brands overall future and the carrying value of
the assets associated with our brands. The recent COVID-19 pandemic may create local issues for our third party-
manufacturers and introduce delays in our manufacturing process.

Acetadote: We have agreements with two manufacturers, and both manufacturers provided commercial
supplies of the product during 2020. If neither of the manufacturers of Acetadote are able to produce marketable
inventory in sufficient quantities, in the agreed upon time period, we could suffer an inability to meet demand for
our product.

Caldolor: We have agreements with multiple manufacturers for the supply of Caldolor and during 2020 we
obtained commercial supplies from three of these manufacturers for our international and domestic Caldolor
requirements. If the manufacturers of Caldolor are unable to produce marketable inventory in sufficient quantities,
in the agreed upon time period, we could suffer an inability to meet demand for our product.

Kristalose: The active pharmaceutical ingredient for Kristalose is manufactured at a single facility by an
international supplier. We also have manufacturing relationships with two packagers who provided finished supplies
of the product for commercial and sampling purposes during 2020. If these facilities are damaged or destroyed, or if
local conditions result in a work stoppage, we could suffer an inability to meet demand for our product. Kristalose is
manufactured through a complex process. It would be particularly difficult to find a new manufacturer of Kristalose
active pharmaceutical ingredient on an expedited basis. As a result of these factors, our ability to manufacture
Kristalose may be substantially impaired if the manufacturer is unable or unwilling to supply sufficient quantities of
the product.

Omeclamox-Pak: Prior to our asset purchase agreement with GEL that closed in December 2018, GEL
managed the packaging and supply of Omeclamox-Pak commercial and sample units. Following our acquisition of
the remaining rights to the brand in late 2018, we assumed responsibility for the packaging and supply of the
product. During 2019 we entered into a new packaging arrangement for this product. The Company has been
carefully monitoring its supply chain during the pandemic and preparing for its economic impact. The packager for
Cumberland’s Omeclamox-Pak product encountered financial difficulties due to the impact of COVID-19, and their
operations are currently suspended. Cumberland is awaiting resumption of those operations while also exploring
other alternatives to restart the product’s packaging. Meanwhile, we informed the FDA of a shortage of the
Omeclamox-Pak effective October 14, 2020, and have not provided a date for the availability of new inventory.
Cumberland noted that there is currently some remaining inventory of the product in the distribution channels. If we
are unable to obtain marketable inventory in the future, we could suffer an inability to meet demand for our product.

Vaprisol: As part of the acquisition of Vaprisol, we purchased an existing supply of raw material inventory. In
addition, as part of this transaction, we were assigned a commercial supply agreement with the historical Vaprisol
manufacturer. In 2018, the manufacturer informed us that they would no longer be able to provide the product
following the manufacturing of one final batch which is providing us with a multi-year supply. We are currently
working with a new manufacturer to provide us with long term supplies of the product. If we are unable to produce
additional marketable inventory in sufficient quantities of Vaprisol, we could suffer an inability to meet demand for
our product.

Vibativ: Through our acquisition of Vibativ, we acquired a multi-year supply of raw material, work in process
and finished goods inventory. As a result of the agreement, we are now responsible for the manufacture of the
product and completed the transfer of the product’s manufacturing activities to a new supplier during 2020. If we are
unable to obtain marketable inventory in the future, we could suffer an inability to meet demand for our product.

RediTrex: Under our agreement with Nordic, they are responsible for providing us the packaged and labeled
commercial supply of the RediTrex product. If we are unable to obtain marketable inventory in the future, we could
suffer an inability to meet demand for our product.

In addition, all manufacturers of our products and product candidates must comply with current good
manufacturing practices, ("GMPs"), enforced by the FDA through its facilities inspection program. These
requirements include quality control, quality assurance and the maintenance of records and documentation.
Manufacturers of our products may be unable to comply with GMP requirements and with other FDA, state and
foreign regulatory requirements.

We have no control over our manufacturers’ compliance with these regulations and standards. If our third-party

manufacturers do not comply with these requirements, we could be subject to:

•

Fines and civil penalties;

Suspension of production or distribution;

Suspension or delay in product approval;

Product seizure or recall; and

• Withdrawal of product approval.

We are dependent on a variety of other third parties. If these third parties fail to perform as we expect, our
operations could be disrupted and our financial results could suffer.

We have a relatively small internal infrastructure. We rely on a variety of third parties, in addition to our

manufacturers, to help us operate our business. Other third parties on which we rely include:

•

Cardinal Health Specialty Pharmaceutical Services, a logistics and fulfillment company and business
unit of Cardinal, which bills for, collects, warehouses and ships our marketed products; and

Vanderbilt University, WinHealth and the Tennessee Technology Development Corporation, co-owners
with us of CET, and the universities that collaborate with us in connection with CET's research and
development programs.

If these third parties do not continue to provide services to us, or collaborate with us, we might not be able to
obtain others who can serve these functions. This could disrupt our business operations, increase our operating
expenses or otherwise adversely affect our operating results. The recent COVID-19 pandemic may create additional
risk and delays at our independent third-party service providers.

Competitive pressures could reduce our revenues and profits.

The pharmaceutical industry is intensely competitive. Our strategy is to target differentiated products in
specialized markets. However, this strategy does not relieve us from competitive pressures and can entail distinct
competitive risks. Certain of our competitors do not aggressively promote their products in our markets. An increase
in promotional activity in our markets could result in large shifts in market share, adversely impacting us.

Our competitors may sell or develop drugs that are more effective and useful or less costly than ours, and they
may be more successful in manufacturing and marketing their products. Many of our competitors have significantly
greater financial and marketing resources than we do. Additional competitors may enter our markets.

The pharmaceutical industry is characterized by constant and significant investment in new product
development, which can result in rapid technological change. The introduction of new products could substantially
reduce our market share or render our products obsolete. The selling prices of pharmaceutical products tend to
decline as competition increases, through new product introduction or otherwise, which could reduce our revenues
and profitability.

If generic products that compete with any of our branded pharmaceutical products are approved and sold, sales
of our products will be adversely affected.

Generic equivalents for branded pharmaceutical products are typically sold at lower costs than the branded
products. The regulatory approval process in the United States exempts generic products from costly and time-
consuming clinical trials to demonstrate their safety and efficacy and rely instead on the safety and efficacy of prior
products, manufacturers of generic products can invest far less in research and development. After the introduction
of a competing generic product, a significant percentage of the prescriptions previously written for the branded
product are often written for the generic version. In addition, legislation enacted in most U.S. states allows or, in
some instances mandates, that a pharmacist dispense an available generic equivalent when filling a prescription for a
branded product, in the absence of specific instructions from the prescribing physician. Governmental and private

healthcare payors also emphasize substitution of branded pharmaceuticals with less expensive generic
equivalents. Pursuant to the provisions of the Hatch-Waxman Act, manufacturers of branded products often bring
lawsuits to enforce their patent rights against generic products released prior to the expiration of branded products’
patents, but it is possible for generic manufacturers to offer generic products while such litigation is pending. As a
result, branded products typically experience a significant loss in revenues following the introduction of a competing
generic product, even if subject to an existing patent. Our branded pharmaceutical products are or may become
subject to competition from generic equivalents because there is no proprietary protection for some of the branded
pharmaceutical products we sell, because our patent protection expires or because our patent protection is not
sufficiently broad or enforceable. In addition, we may not be successful in our efforts to extend the proprietary
protection afforded our branded products through the development and commercialization of proprietary product
improvements. Competition from generic equivalents could result in a decrease in revenues of our branded
pharmaceuticals or result in a material impairment of our intangible assets or the acceleration of amortization on our
non-impaired intangible assets and may have a material adverse impact on our revenues, financial condition, results
of operations and cash flows.

Any attempt by us to expand the potential market for any of our products is subject to limitations.

Expansion of the market for our products may be subject to certain limitations. In the past, these limitations
have included FDA required Phase IV commitments. We may also experience delays associated with future required
Phase IV clinical studies potentially resulting from, among other factors, difficulty enrolling patients. Such delays
could impact our ability to explore opportunities for label expansion and limit our ability to bring our products to
new patient populations.

In addition, we have largely obtained regulatory approval to market our products in the United States. Not all
foreign jurisdictions may represent attractive opportunities for our products due to pricing, competitive, regulatory
or other factors. In certain foreign jurisdictions, we have licensed the right to market some of our products to third
parties. These third parties are responsible for seeking and maintaining regulatory approval for the products in their
respective jurisdictions. We have no control over these third parties and cannot be sure that marketing approval for
our products will be obtained outside the United States.

Our future growth depends on our ability to identify and acquire rights to products. If we do not successfully
identify and acquire rights to products, our growth opportunities may be limited.

We acquired rights to our products and our product candidates. Our business strategy is to continue to acquire
rights to FDA-approved products as well as pharmaceutical product candidates in the late stages of development.
We do not plan to conduct basic research or preclinical product development, except to the extent of our investment
in CET. As compared to large multi-national pharmaceutical companies, we have limited resources to acquire third-
party products, businesses and technologies and integrate them into our current infrastructure. Many acquisition
opportunities involve competition among several potential purchasers including large multi-national pharmaceutical
companies and other competitors that have access to greater financial resources than we do. With future acquisitions,
we may face financial and operational risks and uncertainties. We may not be able to engage in future product
acquisitions, and those we do complete may not be beneficial to us in the long term.

Furthermore, other products in development may encounter unforeseen issues during their clinical trials. Any
unforeseen issues or lack of FDA approval will negatively affect marketing and development plans for those
products.

Our future growth depends on our ability to successfully integrate acquired product brands into our operations.
If we do not successfully integrate acquired product brands into our operations, our growth opportunities may be
limited.

We added six marketed products to our portfolio of brands, roughly one brand per year, beginning in late 2013
through the launch of RediTrex during late 2020. If we are unable to continue to optimize our sales of our brands or
we are unable to successfully integrate the marketing, sale and distribution of any other potential products into our
current infrastructure or if they require significantly greater resources than originally anticipated, we may face

financial and operational risks and uncertainties. If we are unable to successfully integrate any acquired brands, both
current and future, these product acquisitions may not be beneficial to us in the long term.

Our Hepatoren, Boxaban, Vasculan, and Portaban product candidates have not been approved for sale and may
never be successfully commercialized.

We anticipate that a portion of our future revenue growth will come from sales of our Hepatoren, Boxaban,
Vasculan, and Portaban product candidates. Hepatoren (intravenous ifetroban) is used to treat hepatorenal syndrome
("HRS"), Boxaban (oral ifetroban) is used to treat aspirin exacerbated respiratory disease ("AERD"), Vasculan (oral
ifetroban) is for the treatment of systemic sclerosis ("SSc"), and Portaban (injection and oral ifetroban) is for the
treatment of portal hypertension associated with liver disease. However, none of these products have been approved
by the FDA for marketing, and these product candidates are still subject to risks associated with their development.

The FDA has cleared our IND's for the ifetroban product candidates as we evaluate them as treatments for these
conditions. Delays in the enrollment and completion of the clinical studies could significantly delay commercial
launch and affect our product development costs. Moreover, results from the clinical studies may not be favorable.

Even if they are eventually developed and approved by the FDA, they may never gain significant acceptance in
the marketplace and therefore never generate substantial revenue or profits for us. Physicians may determine that
existing drugs are adequate to address patients' needs. The extent to which these product candidates will be
reimbursed by the U.S. government or third-party payors is also currently unknown.

As a result of the foregoing and other factors, we do not know the extent to which our product candidates will

contribute to our future growth.

If we are unable to maintain, train and build an effective sales and marketing infrastructure, we will not be able
to commercialize and grow our products and product candidates successfully.

As we grow, we may not be able to secure sales personnel or organizations that are adequate in number or
expertise to successfully market and sell our products. This risk would be accentuated if we acquire products in
areas outside of our current focus areas since our sales forces specialize in our existing areas. If we are unable to
expand our sales and marketing capability, train our sales force effectively or provide any other capabilities
necessary to commercialize our products and product candidates, we will need to contract with third parties to
market and sell our products. We must train our employees on proper regulatory compliance, including, but not
limited to, “fair balance” promotion of our products and anti-kickback laws. If we are unable to establish and
maintain compliant and adequate sales and marketing capabilities, we may not be able to increase our product
revenue, may generate increased expenses and may experience regulatory compliance issues.

If governmental or third-party payors do not provide adequate reimbursement for our products, our revenue and
prospects for profitability may be limited.

Our financial success depends, in part, on the availability of adequate reimbursement from third-party
healthcare payors. Such third-party payors include governmental health programs such as Medicare and Medicaid,
managed care providers and private health insurers. Third-party payors are increasingly challenging the pricing of
medical products and services, while governments continue to propose and pass legislation designed to reduce the
cost of healthcare. Adoption of such legislation could further limit reimbursement for pharmaceuticals.

In March 2010, the U.S. government passed into law the Patient Protection and Affordable Care Act,
("PPACA") along with the Health Care and Education Reconciliation Act of 2010, ("HCERA"), which modified the
revenue provisions of the PPACA. The legislation calls for an increase in certain Medicare drug rebates paid by
pharmaceutical manufacturers and an industry fee imposed on pharmaceutical manufacturers according to the
individual manufacturer’s relative percentage of total industry sales to specified government programs. At this time
no assurances can be given that these measures, or any other measures included in the Healthcare Reform Act, will
not have an adverse effect on our revenues in the future. Future cost control initiatives, legislation and regulations
could decrease the price that we receive for any products, which would limit our revenue and profitability.

Since its inception, other legislative changes have been proposed and adopted. These changes included
aggregate reductions of Medicare payments to providers of up to two percent per fiscal year. Additionally, in
January 2013, the American Taxpayer Relief Act of 2012, was signed into law which, among other things, reduced
Medicare payments to several providers, and increased the statute of limitations period for the government to
recover overpayments to providers from three to five years. Further, while the healthcare reform agenda and policies
of the current administration are not fully known, it is possible that additional regulatory changes may take place.
This includes a repeal of all or portions of the PPACA, and Congress could be asked to replace the current
legislation of the PPACA. There is uncertainty with respect to the timing and impact of any changes. These changes
could have an impact on coverage and reimbursement for healthcare products and services covered by plans that
were authorized by the PPACA. At this time, we cannot predict the ultimate content, timing or effect of any
healthcare reform legislation or the impact of potential legislation on us.

Also, reimbursement practices of third-party payors might preclude us from achieving market acceptance for
our products or maintaining price levels sufficient to realize an appropriate return on our investment in product
acquisition and development. If we cannot obtain adequate reimbursement levels, our business, financial condition
and results of operations would be materially and adversely affected.

Our employees have been trained to submit accurate and correct pricing information to payors. If, despite the
training, our employees provide incorrect or fraudulent information, then we will be subject to various
administrative and judicial investigations and litigation.

“Formulary” practices of third-party payors could adversely affect our competitive position.

Many managed healthcare organizations are now controlling the pharmaceutical products included on their
formulary lists. Having products listed on these formulary lists creates competition among pharmaceutical
companies which, in turn, has created a trend of downward pricing pressure in our industry. In addition, many
managed care organizations are pursuing various ways to reduce pharmaceutical costs and are considering formulary
contracts primarily with those pharmaceutical companies that can offer a full line of products for a given therapy
sector or disease state. Our products might not be included on the formulary lists of managed care organizations, and
downward pricing pressure in our industry generally could negatively impact our operations.

Continued consolidation of distributor networks in the pharmaceutical industry as well as increases in retailer
concentration may limit our ability to profitably sell our products.

We sell most of our products to large pharmaceutical wholesalers, who in turn sell to hospitals, surgery centers
and retail pharmacies. The distribution network for pharmaceutical products has become increasingly consolidated
in recent years. Further consolidation or financial difficulties could also cause our customers to reduce the amounts
of our products that they purchase, adversely impacting our business, financial condition and results of operations.

Our CET joint initiative may not result in our gaining access to commercially viable products.

Our CET joint initiative with Vanderbilt University, WinHealth and Tennessee Technology Development
Corporation is designed to help us investigate, in a cost-effective manner, early-stage products and technologies.
However, we may never gain access to commercially viable products from CET for a variety of reasons, including:

•

CET investigates early-stage products, which have risk of failure prior to FDA approval and
commercialization;

In some programs, we do not have pre-set rights to product candidates developed by CET. We would
need to agree with CET and its collaborators on the terms of any product licensed or acquired by us;

• We rely principally on government grants to fund CET’s research and development programs. If these
grants were no longer available, we or our co-owners might be unable or unwilling to fund CET
operations at current levels or at all;

• We may become involved in disputes with our co-owners regarding CET policy or operations, such as
how best to deploy CET assets or which product opportunities to pursue. Disagreement could disrupt
or halt product development; and

•

CET may disagree with one of the various universities with which CET is collaborating on research. A
disagreement could disrupt or halt product development.

We depend on our key personnel, the loss of whom would adversely affect our operations. If we fail to attract and
retain the talent required for our business, our business will be materially harmed.

We are a relatively small company, and we depend to a great extent on principal members of our management,
scientific staff, and sales representatives and managers. If we lose the services of any key personnel, in particular,
A.J. Kazimi, our Chief Executive Officer, or other members of senior management it could have a material adverse
effect on our business prospects. Mr. Kazimi, plays a key role in several operational and strategic decisions such that
any loss of his services due to death or disability would adversely impact our day-to-day operations. We have a life
insurance policy covering the life of Mr. Kazimi. We have entered into agreements with each of our employees that
contain restrictive covenants relating to non-competition and non-solicitation of our customers and suppliers for one
year after termination of employment. Nevertheless, each of our officers and key employees may terminate his or
her employment at any time without notice and without cause or good reason, and so as a practical matter these
agreements do not guarantee the continued service of these employees. Our success depends on our ability to attract
and retain highly qualified scientific, technical, sales and managerial personnel and research partners. Competition
among pharmaceutical companies for qualified employees is intense, and we may not be able to retain existing
personnel or attract and retain qualified staff in the future. If we experience difficulties in hiring and retaining
personnel in key positions, we could suffer from delays in product development, loss of customers and sales and
diversion of management resources, which could adversely affect operating results. The recent COVID-19
pandemic may introduce additional challenges in the retention and hiring of key personnel.

The size of our organization and our potential growth may lead to difficulties in managing operations.

As of December 31, 2020, we had 90 employees. We may need to continue to expand our managerial,
operational, financial and other resources in order to increase our marketing efforts with regard to our currently
marketed products, continue our business development and product development activities and commercialize our
product candidates. We have experienced, and may continue to experience, growth and increased expenses in the
scope of our operations in connection with the continued marketing and development of our products. Our financial
performance will depend, in part, on our ability to manage any such growth and expenses of the current organization
effectively.

We face potential product liability exposure, and if successful claims are brought against us, we may incur
substantial liability for a product or product candidate and may have to limit its commercialization.

We face an inherent risk of product liability lawsuits related to the testing of our product candidates and the
commercial sale of our products. An individual may bring a liability claim against us if one of our product
candidates or products causes, or appears to have caused, an injury. If we cannot successfully defend ourselves
against the product liability claim, we may incur substantial liabilities. Liability claims may result in:

•

Decreased demand for our products;

Injury to our reputation;

• Withdrawal of clinical trial participants;

•

Significant litigation costs;

Substantial monetary awards to or costly settlement with patients;

Product recalls;

Loss of revenue; and

The inability to commercialize our product candidates.

We are highly dependent upon medical and patient perceptions of us and the safety and quality of our products.
We could be adversely affected if we or our products are subject to negative publicity. We could also be adversely
affected if any of our products or any similar products sold by other companies prove to be, or are asserted to be,
harmful to patients. Also, because of our dependence upon medical and patient perceptions, any adverse publicity
associated with illness or other adverse effects resulting from the use or misuse of our products or any similar
products sold by other companies could have a material adverse impact on our results of operations.

We have product liability insurance that covers our clinical trials, the marketing and sale of our products up to a
$10 million annual aggregate limit, subject to specified deductibles. Our current or future insurance coverage may
prove insufficient to cover any liability claims brought against us.

Because of the increasing costs of insurance coverage, we may not be able to maintain insurance coverage at a

reasonable cost or obtain insurance coverage that will be adequate to satisfy any liability that may arise.

Regulatory approval for any approved product is limited by the FDA to those specific indications and conditions
for which clinical safety and efficacy have been demonstrated.

Any regulatory approval is limited to those specific diseases and indications for which a product is deemed to
be safe and effective by the FDA. In addition to the FDA approval required for new formulations, any new
indication for an approved product also requires FDA approval. If we are not able to obtain FDA approval for any
desired future indications for our products, our ability to effectively market and sell our products may be reduced
and our business may be adversely affected.

While physicians may choose to prescribe drugs for uses that are not described in the product’s labeling and for
uses that differ from those tested in clinical studies and approved by the regulatory authorities, our ability to promote
the products is limited to those indications that are specifically approved by the FDA. These “off-label” uses are
common across medical specialties and may constitute an appropriate treatment for some patients in varied
circumstances. Regulatory authorities in the U.S. generally do not regulate the behavior of physicians in their choice
of treatments. Regulatory authorities do, however, restrict communications by pharmaceutical companies on the
subject of off-label use. If our promotional activities fail to comply with these regulations or guidelines, we may be
subject to warnings from, or enforcement action by, these authorities. In addition, our failure to follow FDA rules
and guidelines relating to promotion and advertising may cause the FDA to suspend or withdraw an approved
product from the market, require a recall or payment of fines, or could result in disgorgement of money, operating
restrictions, injunctions or criminal prosecution, any of which could harm our business.

Our business and operations would suffer in the event of system failures, security breaches, including any
cybersecurity incidents, adverse events or other disruptions within our information technology infrastructure at
our corporate headquarters.

Despite the implementation of security measures, our internal computer systems, including those at our
corporate headquarters, are vulnerable to damage from cyber-attacks, computer viruses, unauthorized access, natural
disasters, terrorism, war and telecommunication and electrical failures. In the ordinary course of our business, we
store sensitive data, including intellectual property, our proprietary business information and that of our customers.
We also maintain personally identifiable information of our employees in our data centers and on our networks. The
secure processing and maintenance of this information is critical to our operations. In the event that our corporate
headquarters and/or our computer systems are disabled or materially damaged, it would have a substantial and
material negative effect on our operations. Furthermore, any system failure, accident or security breach that causes
interruptions in our operations could result in a material disruption of our drug development programs. While we
continue to invest in data protection and information technology, our information technology and infrastructure may
be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions. Any such
breach could compromise our networks and the information stored there could be accessed, publicly disclosed, lost
or stolen. To the extent that any disruption or security breach results in a loss or damage to our data or applications,
or inappropriate disclosure of confidential or proprietary information, we may incur liability and the further
development of our products or product candidates may be delayed.

We may develop internationally and license our products globally; therefore, we may have an increased exposure
to foreign regulatory requirements and fluctuations in foreign currency exchange rates.

While we currently have only obtained regulatory approval to market our products in the United States, in the
future we may seek global opportunities for our products and to develop product candidates internationally in the
future. Such opportunities and development will inherently subject us to a number of risks and uncertainties,
including:

•

longer payment cycles and difficulties in enforcing agreements and collecting receivables through
certain foreign legal systems;

political and economic instability or sanctions in areas in which we operate;

potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements and other
trade barriers;

regulations related to customs and import/export matters (including sanctions);

tax issues, such as tax law changes and variations in tax laws;

challenges in collecting accounts receivable from customers in the jurisdictions in which we operate;

complying with laws, rules and regulations relating to the manufacturing, marketing, distribution and
sale of pharmaceutical products in the jurisdictions in which we do or will operate;

operating under regulations in jurisdictions related to obtaining eligibility for government or private
payor reimbursement for our products at the wholesale/retail level;

competition from local, regional and international competitors;

difficulties and costs of staffing and managing foreign operations, including cultural and language
differences and additional employment regulations, union workforce negotiations and potential
disputes in the jurisdictions in which we operate;

difficulties associated with compliance with a variety of laws and regulations governing international
trade, including the Foreign Corrupt Practices Act;

difficulties protecting or procuring intellectual property rights; and

fluctuations in foreign currency exchange rates.

Any of these factors may, individually or as a group, have a material adverse effect on our business and results
of operations. These or other similar risks could adversely affect our revenue and profitability. As we develop
internationally, our exposure to these factors will increase.

Even if a drug candidate that we develop receives regulatory approval, we may decide not to commercialize it if
we determine that commercialization of that product would require more capital and time than we are willing to
invest.

Even if any of our drug candidates receives regulatory approval, it could be subject to post-regulatory surveillance,
and may have to be withdrawn from the market or subject to restrictions if previously unknown problems occur.
Regulatory agencies may also require additional clinical trials or testing, and the drug product may be recalled or
may be subject to reformulation, additional studies, changes in labeling, warnings to the public and negative
publicity. As a result, we may not continue to commercialize a product even though it has obtained regulatory
approval. Further, we may decide not to continue to commercialize a product if the market does not accept the
product because it is too expensive or because third parties, such as insurance companies or Medicare, have not
approved it for substantial reimbursement. In addition, we may decide not to continue to commercialize a product if
competitors develop and commercialize similar or superior products or have proprietary rights that preclude us from
ultimately marketing our products.

Any approved drug product that we bring to the market may not gain market acceptance by physicians, patients,
healthcare payors and others in the medical community.

Even if we are successful in gaining regulatory approval of any of our drug candidates or acquire rights to approved
drug products, we may not generate significant product revenues and we may not become profitable if these drug
products do not achieve an adequate level of acceptance. Physicians may not recommend our drug products until
longer-term clinical data or other factors demonstrate the safety and efficacy of our drug products as compared to
other alternative treatments. Even if the clinical safety and efficacy of our drug products is established, physicians
may elect not to prescribe these drug products for a variety of reasons, including the reimbursement policies of
government and other third-party payors and the effectiveness of our competitors in marketing their products.

Market acceptance of our drug products, if approved for commercial sale, will depend on a number of factors,
including:

•

the willingness and ability of patients and the healthcare community to use our drug products;

the ability to manufacture our drug products in sufficient quantities with acceptable quality and to offer our
drug products for sale at competitive prices;

the perception of patients and the healthcare community, including third-party payors, regarding the safety,
efficacy and benefits of our drug products compared to those of competing products or therapies;

the label and promotional claims allowed by the FDA; and

the pricing and reimbursement of our drug products relative to existing treatments.

We may acquire businesses or assets, form joint ventures or make investments in other companies that may be
unsuccessful, divert our management’s attention and harm our operating results and prospects.

As part of our business strategy, we may pursue additional acquisitions of what we believe to be complementary
businesses or assets or seek to enter into joint ventures. We also may pursue strategic alliances in an effort to
leverage our existing infrastructure and industry experience to expand our product offerings or distribution, or make
investments in other companies. The success of our acquisitions, joint ventures, strategic alliances and investments
will depend on our ability to identify, negotiate, complete and, in the case of acquisitions, integrate those
transactions and, if necessary, obtain satisfactory debt or equity financing to fund those transactions. We may not
realize the anticipated benefits of any acquisition, joint venture, strategic alliance or investment. We may not be able
to integrate acquisitions successfully into our existing business, maintain the key business relationships of
businesses we acquire, or retain key personnel of an acquired business, and we could assume unknown or contingent
liabilities or incur unanticipated expenses. Integration of acquired companies or businesses also may require
management resources that otherwise would be available for ongoing development of our existing business. Any
acquisitions or investments made by us also could result in significant write-offs or the incurrence of debt and
contingent liabilities, any of which could harm our operating results. In addition, if we choose to issue shares of our
stock as consideration for any acquisition, dilution to our shareholders could result.

The acquisitions we have made or make in the future may make us the subject of lawsuits from either an
acquired company’s shareholders, an acquired company’s previous shareholders, or our current shareholders.

We may be the subject of lawsuits from either an acquired company’s shareholders, an acquired company’s previous
shareholders, or our current shareholders. These lawsuits could result from the actions of the acquisition target prior
to the date of the acquisition, from the acquisition transaction itself, or from actions after the acquisition. Defending
potential lawsuits could cost us significant expense and distract management’s attention from the operation of the
business. Additionally, these lawsuits could result in the cancellation of, or the inability to renew, certain insurance
coverage that would be necessary to protect our assets.

We may be required to modify our business practices, pay fines and significant expenses or experience other
losses due to governmental investigations or other enforcement activities.

We may become subject to litigation or governmental investigations in the United States and foreign jurisdictions
that may arise from the conduct of our business. Like many companies in our industry, we have from time to time
received inquiries and other types of information requests from government authorities.

While the ultimate outcomes of investigations and legal proceedings are difficult to predict, adverse resolutions or
settlements of those matters could result in, among other things:

•

significant damage awards, fines, penalties or other payments, and administrative remedies, such as
exclusion and/or debarment from government programs, or other rulings that preclude us from operating
our business in a certain manner;

changes and additional costs to our business operations to avoid risks associated with such litigation or
investigations;

product recalls;

reputational damage and decreased demand for our products; and

expenditure of significant time and resources that would otherwise be available for operating our business.

RISKS RELATING TO GOVERNMENT REGULATION

We are subject to stringent government regulation. All of our products face regulatory challenges.

Virtually all aspects of our business activities are regulated by government agencies. The manufacturing,
processing, formulation, packaging, labeling, distribution, promotion and sampling, advertising of our products, and
disposal of waste products arising from such activities are subject to governmental regulation. These activities are
regulated by one or more of the FDA, the Federal Trade Commission, ("FTC"), the Consumer Product Safety
Commission, the U.S. Department of Agriculture and the U.S. Environmental Protection Agency, ("EPA"), as well
as by comparable agencies in foreign countries. These activities are also regulated by various agencies of the states
and localities in which our products are sold. For more information, see “Business—Government Regulation" in Part
I, Item 1 of this Form 10-K.

Like all pharmaceutical manufacturers, we are subject to regulation by the FDA under the Federal Food, Drug
and Cosmetic Act ("FDCA"). All new drugs must be the subject of an FDA-approved new drug application,
("NDA"), before they may be marketed in the United States. The FDA has the authority to withdraw existing NDA
approvals and to review the regulatory status of products marketed under the enforcement policy. The FDA may
require an approved NDA for any drug product marketed under the enforcement policy if new information reveals
questions about the drug’s safety and effectiveness. All drugs must be manufactured in conformity with GMP, and
drug products subject to an approved NDA must be manufactured, processed, packaged, held and labeled in
accordance with information contained in the NDA. Since we rely on third parties to manufacture our products,
GMP requirements directly affect our third party manufacturers and indirectly affect us. The manufacturing facilities
of our third-party manufacturers are continually subject to inspection by such governmental agencies, and
manufacturing operations could be interrupted or halted in any such facilities if such inspections prove
unsatisfactory. Our third-party manufacturers are subject to periodic inspection by the FDA to assure such
compliance.

Even after regulatory approval, certain developments may decrease demand for our products, including the

following:

•

the re-review of products that are already marketed;

new scientific information and evolution of scientific theories;

the recall or loss of marketing approval of products that are already marketed;

•

changing government standards or public expectations regarding safety, efficacy or labeling changes;
and

greater scrutiny in advertising and promotion.

In the past, clinical trials and post-marketing surveillance of certain marketed drugs of competitors within the
industry have raised concerns that have led to recalls, withdrawals or adverse labeling of marketed products. If
previously unknown side effects are discovered or if there is an increase in negative publicity regarding known side
effects of any of our products, it could significantly reduce demand for the product or require us to take actions that
could negatively affect sales, including removing the product from the market, restricting its distribution or applying
for labeling changes.

In addition, certain health authorities, regulators and agencies have increased their focus on safety when
assessing the balance of benefits and risks of drugs. Some health authorities appear to have become more cautious
when making decisions about approvability of new products and are re-reviewing select products that are already
marketed, adding further to the uncertainties in the regulatory processes. There is also greater regulatory scrutiny,
especially in the U.S., on advertising, and promotion (in particular, direct-to-consumer advertising) and pricing of
pharmaceutical products. Certain regulatory changes or decisions could make it more difficult for us to sell our
products and could have a material adverse effect on our business, results of operations, financial condition and cash
flows.

Manufacturers of drug products and their facilities are subject to continual review and periodic inspections by
the FDA and other regulatory authorities for compliance with GMP and other applicable regulations. If we or a
regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated
severity or frequency, or problems with a facility where the product is manufactured, a regulatory agency may
impose restrictions on that product or the manufacturer, including withdrawal of the product from the market or
suspension of manufacturing. If we, our partners or the manufacturing facilities for our products fail to comply with
applicable regulatory requirements, a regulatory agency may take the following actions, among others:

•

issue warning letters or untitled letters;

impose civil or criminal penalties

suspend or withdraw regulatory approval;

suspend any ongoing clinical trials;

refuse to approve pending applications or supplements to applications submitted by us;

impose restrictions on operations, including costly new manufacturing requirements; or

seize or detain products or require us to initiate a product recall.

Any change in the FDA’s enforcement policy could have a material adverse effect on our business, financial
condition and results of operations. We cannot determine what effect changes in regulations or statutes or legal
interpretation, when and if promulgated or enacted, may have on our business in the future. Such changes, or new
legislation, could have a material adverse effect on our business, financial condition and results of operations.

The recent COVID-19 pandemic has introduced additional strain on the FDA. We are unable to fully understand

the impact this may cause on regulations or the related timeframes pertaining to communication with the FDA.

Proposed legislation may permit re-importation of drugs from other countries into the U.S., including foreign
countries where the drugs are sold at lower prices than in the U.S., which could materially and adversely affect
our operating results and our overall financial condition.

In previous years, legislation has been introduced in Congress that, if enacted, would permit more widespread
re-importation of drugs from foreign countries into the U.S., which may include re-importation from foreign
countries where the drugs are sold at lower prices than in the U.S. Based on recent election results, there could be a
renewed effort for legislation permitting the re-importation of prescription drugs as a means of lowering drug costs.

Such legislation, or similar regulatory changes, if enacted, could decrease the price we receive for any approved
products which, in turn, could materially and adversely affect our operating results and our overall financial
condition.

We must comply with the Foreign Corrupt Practices Act.

We are required to comply with the United States Foreign Corrupt Practices Act, which prohibits U.S.
companies from engaging in bribery or other prohibited payments to foreign officials for the purpose of obtaining or
retaining business. Foreign companies, including some of our competitors, are not subject to these prohibitions. If
our competitors engage in these practices, they may receive preferential treatment from officials or agencies in some
countries, giving our competitors an advantage in securing business from government officials who might give them
priority in obtaining new licenses, which would put us at a disadvantage. We have established formal policies or
procedures for prohibiting or monitoring this conduct, but we cannot assure you that our employees or other agents
will not engage in such conduct for which we might be held responsible. If our employees or other agents are found
to have engaged in such practices, we could suffer severe penalties.

We must comply with the Physician Payment Sunshine Act.

We are required to comply with the United States Physician Payment Sunshine Act, which requires
manufacturers of drugs, medical devices and biologicals that participate in U.S. federal healthcare programs to
report certain payments and items of value given to physicians and teaching hospitals. Manufacturers are required to
report this information annually to The Centers for Medicare & Medicaid Services ("CMS"). Cumberland has
implemented a series of policies and procedures for every employee involved in the data collection process, and has
systems in place to capture the data, which is verified by an outside firm that specializes in reporting the payments.
Cumberland has also established a system to ensure that data was reported completely, in the correct format, and on
time. Despite these policies, procedures and systems, we cannot assure you that we will collect and report all data
accurately. If we fail to accurately report this information, we could suffer severe penalties.

If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or
other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties,
sanctions and fines, which could have a material adverse effect on our business, financial condition, results of
operations and growth prospects.

We participate in and have certain price reporting obligations to the Medicaid Drug Rebate program and other

governmental pricing programs, and we have obligations to report average sales price under the Medicare program.

Under the Medicaid Drug Rebate program, we are required to pay a rebate to each state Medicaid program for
our covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program
as a condition of having federal funds being made available to the states for our drugs under Medicaid and Medicare
Part B. Those rebates are based on pricing data reported by us on a monthly and quarterly basis to CMS, the federal
agency that administers the Medicaid Drug Rebate program. These data include the average manufacturer price and,
in the case of innovator products, the best price for each drug which, in general, represents the lowest price available
from the manufacturer to any entity in the US in any pricing structure, calculated to include all sales and associated
rebates, discounts and other price concessions.

The Healthcare Reform Act made significant changes to the Medicaid Drug Rebate program, such as expanding
rebate liability from fee-for-service Medicaid utilization to include the utilization of Medicaid managed care
organizations as well and changing the definition of average manufacturer price. The Healthcare Reform Act also
increased the minimum Medicaid rebate; changed the calculation of the rebate for certain innovator products that
qualify as line extensions of existing drugs; and capped the total rebate amount at 100% of the average manufacturer
price. Finally, the Healthcare Reform Act requires pharmaceutical manufacturers of branded prescription drugs to
pay a branded prescription drug fee to the federal government.

CMS issued final regulations to implement the changes to the Medicaid Drug Rebate program under the
Healthcare Reform Act. These regulations became effective on April 1, 2016. The issuance of the final regulations
and coverage expansion by various governmental agencies relating to the Medicaid Drug Rebate program has and
will continue to increase our costs and the complexity of compliance, has been and will continue to be time-
consuming to implement, and could have a material adverse effect on our results of operations, particularly if CMS
challenges the approach we take in our implementation of the final regulations.

Federal law requires that any company that participates in the Medicaid Drug Rebate program also participate in
the Public Health Service's 340B drug pricing program in order for federal funds to be available for the
manufacturer's drugs under Medicaid and Medicare Part B. The 340B program requires participating manufacturers
to agree to charge no more than the 340B "ceiling price" for the manufacturer's covered outpatient drugs to a variety
of community health clinics and other entities that receive health services grants from the Public Health Service, as
well as hospitals that serve a disproportionate share of low-income patients. The Healthcare Reform Act expanded
the list of covered entities to include certain free-standing cancer hospitals, critical access hospitals, rural referral
centers and sole community hospitals. The 340B ceiling price is calculated using a statutory formula based on the
average manufacturer price and rebate amount for the covered outpatient drug as calculated under the Medicaid
Drug Rebate program. Changes to the definition of average manufacturer price and the Medicaid rebate amount
under the Healthcare Reform Act and CMS's final regulations implementing those changes also could affect our
340B ceiling price calculations and negatively impact our results of operations.

The Healthcare Reform Act obligates the Secretary of the Department of Health and Human Services ("HHS")
to update the agreement that manufacturers must sign to participate in the 340B program to obligate a manufacturer
to offer the 340B price to covered entities if the manufacturer makes the drug available to any other purchaser at any
price and to report to the government the ceiling prices for its drugs. The Health Resources and Services
Administration ("HRSA"), the federal agency that administers the 340B program, recently updated the agreement
with participating manufacturers. The Healthcare Reform Act also obligates the Secretary of the HHS to create
regulations and processes to improve the integrity of the 340B program. On January 5, 2017, HRSA issued a final
regulation regarding the calculation of 340B ceiling price and the imposition of civil monetary penalties on
manufacturers that knowingly and intentionally overcharge covered entities. The regulation became effective as of
January 1, 2019. Implementation of this final rule and the issuance of any other final regulations and guidance could
affect our obligations under the 340B program in ways we cannot anticipate. In addition, legislation may be
introduced that, if passed, would further expand the 340B program to additional covered entities or would require
participating manufacturers to agree to provide 340B discounted pricing on drugs used in the inpatient setting.

Federal law also requires that a company that participates in the Medicaid Drug Rebate program report average
sales price information each quarter to CMS for certain categories of drugs that are paid under the Medicare Part B
program. Manufacturers calculate the average sales price based on a statutorily defined formula as well as
regulations and interpretations of the statute by CMS. CMS uses these submissions to determine payment rates for
drugs under Medicare Part B. Statutory or regulatory changes or CMS guidance could affect the average sales price
calculations for our products and the resulting Medicare payment rate, and could negatively impact our results of
operations. Also, the Medicare Part B drug payment methodology is subject to change based on potential
demonstration projects undertaken by CMS or potential legislation enacted by Congress.

Pricing and rebate calculations vary across products and programs, are complex, and are often subject to
interpretation by us, governmental or regulatory agencies and the courts. In the case of our Medicaid pricing data, if
we become aware that our reporting for a prior quarter was incorrect, or has changed as a result of recalculation of
the pricing data, we are obligated to resubmit the corrected data for up to three years after those data originally were
due. Such restatements and recalculations increase our costs for complying with the laws and regulations governing
the Medicaid Drug Rebate program and could result in an overage or underage in our rebate liability for past
quarters. Price recalculations also may affect the ceiling price at which we are required to offer our products under
the 340B program.

We are liable for errors associated with our submission of pricing data. In addition to retroactive rebates and the
potential for 340B program refunds, if we are found to have knowingly submitted any false price information to the
government, we may be liable for civil monetary penalties. If we are found to have made a misrepresentation in the
reporting of our average sales price, the Medicare statute provides for civil monetary penalties for each
misrepresentation for each day in which the misrepresentation was applied. Our failure to submit the required price
data on a timely basis could result in a civil monetary penalty per day for each day the information is late beyond the
due date. Such failure also could be grounds for CMS to terminate our Medicaid drug rebate agreement, pursuant to
which we participate in the Medicaid program. In the event that CMS terminates our rebate agreement, federal
payments may not be available under Medicaid or Medicare Part B for our covered outpatient drugs.

CMS and the Office of Inspector General ("OIG") have pursued manufacturers that were alleged to have failed
to report these data to the government in a timely manner. Governmental agencies may also make changes in
program interpretations, requirements or conditions of participation, some of which may have implications for
amounts previously estimated or paid. We cannot assure you that our submissions will not be found by CMS to be
incomplete or incorrect.

In order to be eligible to have our products paid for with federal funds under the Medicaid and Medicare Part B
programs we are required to participate in the VA Federal Supply Schedule ("FSS") pricing program, established
under Section 603 of the Veterans Health Care Act of 1992.

Failure to make necessary disclosures and/or to identify contract overcharges can result in allegations against us
under the False Claims Act and other laws and regulations. Unexpected refunds to the government, and any response
to government investigation or enforcement action, would be expensive and time-consuming, and could have a
material adverse effect on our business, financial condition, results of operations and growth prospects.

The recent COVID-19 pandemic may introduce temporary or permanent healthcare reform measures for which

we cannot predict the financial implication of on our business.

RISKS RELATING TO INTELLECTUAL PROPERTY

Our strategy to secure and extend marketing exclusivity or patent rights may provide only limited or no protection
from competition.

We seek to secure and extend marketing exclusivity for our products through a variety of means, including FDA
exclusivity and patent rights. Additional barriers for competitors seeking to enter the market include the time and
cost associated with the development, regulatory approval and manufacturing of a similar product formulation.

As discussed in Part I, Item 1, Business - Patents, Trademarks, and Other Intellectual Proprietary Rights, of
this report on Form 10-K, we have several patents for formulations of Acetadote, and have previously engaged in
litigation to enforce our patent rights.

We also have additional patent applications relating to Acetadote which are pending with the USPTO and may
or may not be issued. We intend to continue to vigorously defend and protect our Acetadote product and related
intellectual property rights. If we are unsuccessful in protecting our Acetadote intellectual property rights, our
competitors may be able to introduce products into the marketplace that reduce the sales and market share of our
Acetadote product which may require us to take measures such as reducing prices or increasing our marketing
expense, any of which may result in a material adverse effect to our financial condition and results of operations.

While we consider patent protection when evaluating product acquisition opportunities, any products we
acquire in the future may not have significant patent protection. Neither the USPTO nor the courts have a consistent
policy regarding the breadth of claims allowed or the degree of protection afforded under many pharmaceutical
patents. Patent applications in the U.S. and many foreign jurisdictions are typically not published until 18 months
following the filing date of the first related application, and in some cases not at all. In addition, publication of
discoveries in scientific literature often lags significantly behind actual discoveries. Therefore, neither we nor our
licensors can be certain that we or they were the first to make the inventions claimed in our issued patents or
pending patent applications, or that we or they were the first to file for protection of the inventions set forth in these
patent applications. In addition, changes in either patent laws or in interpretations of patent laws in the U.S. and

other countries may diminish the value of our intellectual property or narrow the scope of our patent protection.
Furthermore, our competitors may independently develop similar technologies or duplicate technology developed by
us in a manner that does not infringe our patents or other intellectual property. As a result of these factors, our patent
rights may not provide any commercially valuable protection from competing products.

If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our
technology and products could be adversely affected.

In addition to patents, we rely upon trade secrets, unpatented proprietary know-how and continuing
technological innovation where we do not believe patent protection is appropriate or attainable. For example, the
manufacturing process for Kristalose involves substantial trade secrets and proprietary know-how. We have entered
into confidentiality agreements with certain key employees and consultants pursuant to which such employees and
consultants must assign to us any inventions relating to our business if made by them while they are our employees,
as well as certain confidentiality agreements relating to the acquisition of rights to products. Confidentiality
agreements can be breached, though, and we might not have adequate remedies for any breach. Also, others could
acquire or independently develop similar technology.

We may depend on certain licensors for the maintenance and enforcement of intellectual property rights and
have limited, if any, control over the amount or timing of resources that our licensors devote on our behalf.

When we license products, we often depend on our licensors to protect the proprietary rights covering those
products. We have limited, if any, control over the amount or timing of resources that our licensors devote on our
behalf or the priority they place on maintaining patent or other rights and prosecuting patent applications to our
advantage. While any such licensor is expected to be contractually obligated to diligently pursue its patent
applications and allow us the opportunity to consult, review and comment on patent office communications, we
cannot be sure that it will perform as required. If a licensor does not perform and if we do not assume the
maintenance of the licensed patents in sufficient time to make required payments or filings with the appropriate
governmental agencies, we risk losing the benefit of all or some of those patent rights.

If the use of our technology conflicts with the intellectual property rights of third parties, we may incur
substantial liabilities, and we may be unable to commercialize products based on this technology in a profitable
manner or at all.

If our products conflict with the intellectual property rights of others, they could bring legal action against us or
our licensors, licensees, manufacturers, customers or collaborators. If we were found to be infringing a patent or
other intellectual property rights held by a third party, we could be forced to seek a license to use the patented or
otherwise protected technology. We might not be able to obtain such a license on terms acceptable to us or at all. If
legal action involving an alleged infringement or misappropriation were to be brought against us or our licensors, we
would incur substantial costs in defending the action. If such a dispute were to be resolved against us, we could be
subject to significant damages, and the manufacturing or sale of one or more of our products could be enjoined.

We may be involved in lawsuits to protect or enforce our patents or the patents of our collaborators or licensors,
which could be costly and time consuming.

We have been involved in lawsuits for infringement of the Acetadote Patents as previously described. Because
of their nature, these lawsuits can be costly and time-consuming, and we only experience limited benefits and patent
protection. A significant adverse ruling in any such lawsuit could put our patents at risk of being invalidated or
interpreted narrowly and could compromise the issuance of our existing patent applications.

Competitors may infringe on our patents or the patents of our collaborators or licensors. To counter
infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-
consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is
unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our
patents do not cover the technology in question. An adverse result in any litigation or defense proceeding could put
one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications
at risk of not issuing.

Interference proceedings brought by the USPTO may be necessary to determine the priority of inventions with
respect to our patent applications or those of our collaborators or licensors. Litigation or interference proceedings
may fail and, even if successful, may result in substantial costs and distraction of our management. We may not be
able, alone or with our collaborators and licensors, to prevent misappropriation of our proprietary rights, particularly
in countries where the laws may not protect such rights as fully as in the United States.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property
litigation, some of our confidential information could be disclosed during this type of litigation. In addition, there
could be public announcements of the results of hearings, motions or other interim proceedings or developments.

If we breach any of the agreements under which we license rights to our products and product candidates from
others, we could lose the ability to continue commercialization of our products and development and
commercialization of our product candidates.

We have exclusive licenses for the marketing and sale of certain products and may acquire additional licenses.
Such licenses may terminate prior to expiration if we breach our obligations under the license agreement related to
these pharmaceutical products. For example, the licenses may terminate if we fail to meet specified quality control
standards, including GMP with respect to the products, or commit a material breach of other terms and conditions of
the licenses. Such early termination could have a material adverse effect on our business, financial condition and
results of operations.

We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their
former employers.

As is common in the biotechnology and pharmaceutical industry, we employ individuals who were previously
employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors.
Although no claims against us are currently pending, we may be subject to claims that we or these employees have
inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers.
Litigation may be necessary to defend against these claims. Even if we are successful in defending against these
claims, litigation could result in substantial costs and be a distraction to management.

RISKS RELATED TO OUR FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Our operating results are likely to fluctuate from period to period.

We are a company actively seeking to deliver significant growth. As we execute our business strategy of adding
new products, increasing market share in our existing growth products and striving to maintain market share in our
other products, we anticipate that there may be fluctuations in our future operating results. We may not be able to
maintain or improve our current levels of revenue or income. Potential causes of future fluctuations in our operating
results may include:

•

New product launches, which could increase revenues but also increase sales and marketing expenses;

Acquisition activity and other charges;

Increases in research and development expenses resulting from the acquisition of a product candidate
that requires significant additional studies and development;

Ability to utilize unrecognized federal and state net operating loss carryforwards as a result of the
exercise of nonqualified options

Changes in the competitive, regulatory or reimbursement environment, which could drive down
revenues or drive up sales and marketing or compliance costs; and

Unexpected product liability or intellectual property claims and lawsuits.

See also “Management’s discussion and analysis of financial condition and results of operations—Liquidity and
capital resources.” Fluctuation in operating results, particularly if not anticipated by investors and other members of
the financial community, could add to volatility in our stock price. The recent COVID-19 coronavirus has

negatively impacted the financial markets and may create additional risk for our customers and their ability to pay
for our products.

Our focus on acquisitions as a growth strategy has created intangible assets whose amortization could negatively
affect our results of operations.

Our total assets include intangible assets related to our acquisitions. As of December 31, 2020, intangible assets
relating to products, which are being amortized, represented approximately 29% of our total assets. We may never
realize the value of these assets. U.S. Generally Accepted Accounting Principles ("GAAP") require that we evaluate
on a regular basis whether events and circumstances have occurred that indicate that all or a portion of the carrying
amount of the asset may no longer be recoverable, in which case we would write down the value of the asset and
take a corresponding charge to earnings. Any determination requiring the write-off of a significant portion of
unamortized intangible assets would adversely affect our results of operations.

We may need additional funding and may be unable to raise capital when needed, which could force us to delay,
reduce or eliminate our product development or commercialization and marketing efforts.

We may need to raise additional funds in order to meet the capital requirements of running our business and
acquiring and developing new pharmaceutical products. If we require additional funding, we may seek to sell
common stock or other equity or equity-linked securities, which could result in dilution to our shareholders. We may
also seek to raise capital through a debt financing, which would result in ongoing debt-service payments and
increased interest expense. Any financings would also likely involve operational and financial restrictions being
imposed on us. We might also seek to sell assets or rights in one or more commercial products or product
development programs. Additional capital might not be available to us when we need it. We are unable to predict
the impact of global credit market trends, and if economic conditions deteriorate, our business, results of operations
and ability to raise needed capital could be materially and adversely affected. If we are unable to raise additional
capital when needed due to the reasons listed above and lack of creditworthiness, bank failures, or price decline in
market investments, we could be forced to scale back our operations to conserve cash.

If we are unable to maintain appropriate internal financial reporting controls and procedures, it could cause us
to fail to meet our reporting obligations, result in the restatement of our financial statements, harm our operating
results, subject us to regulatory scrutiny and sanction, cause investors to lose confidence in our reported financial
information and have a negative effect on the market price for shares of our common stock.

Effective internal controls are necessary for us to provide reliable financial reports and mitigate the risk of
fraud. We maintain a system of internal control over financial reporting, which is defined as a process designed by,
or under the supervision of, our principal executive officer and principal financial officer, and affected by our board
of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external purposes in accordance with GAAP.

We cannot assure you that we will not, in the future, identify areas requiring improvement in our internal
control over financial reporting. We cannot assure you that the measures we will take to improve these controls will
be successful or that we will implement and maintain adequate controls over our financial processes and reporting in
the future as we continue to expand. If we are unable to establish appropriate internal financial reporting controls
and procedures, it could cause us to fail to meet our reporting obligations, result in the restatement of our financial
statements, harm our operating results, subject us to regulatory scrutiny and sanction, cause investors to lose
confidence in our reported financial information and have a negative effect on the market price for shares of our
common stock.

In addition, we maintain a system of internal controls and provide training to employees designed to provide
reasonable assurance that unlawful and fraudulent activity, including misappropriation of assets, fraudulent financial
reporting, and unauthorized access to sensitive or confidential data is either prevented or timely detected. However,
in the event that our employees engage in such fraudulent behavior, we could suffer material adverse consequences.

Changes in, or interpretations of, accounting principles could have a significant impact on our financial

position and results of operations.

We prepare our consolidated financial statements in accordance with GAAP. These principles are subject to
interpretation by the SEC and various bodies formed to interpret and create appropriate accounting principles. A
change in these principles can have a significant effect on our reported results and may even retroactively affect
previously reported transactions.

For example, in recent years, the U.S.-based Financial Accounting Standards Board, ("FASB"), has worked
together with the International Accounting Standards Board, ("IASB"), on several projects to further align
accounting principles and facilitate more comparable financial reporting between companies who are required to
follow GAAP under SEC regulations and those who are required to follow International Financial Reporting
Standards, ("IFRS"), outside of the U.S. These efforts by the FASB and IASB may result in different accounting
principles under GAAP that may result in materially different financial results for us in certain areas.

We may incur losses in the future and we may not achieve or maintain profitability.

We intend to continue to spend significant amounts on our efforts to discover and develop drugs. As a result, we

may incur losses in future periods.

We anticipate that our drug discovery and development efforts and related expenditures will increase as we
focus on the studies, including clinical trials prior to seeking regulatory approval, that are required before we can sell
a drug product.

The development of drug products will require us to spend significant funds on research, development, testing,

obtaining regulatory approvals, manufacturing and marketing.

We cannot be certain whether or when we will achieve profitability because of the significant uncertainties
relating to our ability to generate commercially successful drug products. Even if we are successful in obtaining
regulatory approvals for manufacturing and commercializing additional drug products, we may incur losses if our
drug products do not generate significant revenues. If we achieve profitability, we may not be able to sustain or
increase profitability.

We may seek to obtain future financing through the issuance of debt or equity, which may have an adverse

effect on our shareholders or may otherwise adversely affect our business.

If we raise funds through the issuance of additional equity, whether through private placements or public
offerings, such an issuance would dilute ownership of our current shareholders that do not participate in the
issuance. If we are unable to obtain any needed additional funding, we may be required to reduce the scope of,
delay, or eliminate some or all of, our planned research, development and commercialization activities or to license
to third parties the rights to develop and/or commercialize products or technologies that we would otherwise seek to
develop and/or commercialize ourselves or on terms that are less attractive than they might otherwise be, any of
which could materially harm our business.

Furthermore, the terms of any additional debt securities we may issue in the future may impose restrictions on
our operations, which may include limiting our ability to incur additional indebtedness, pay dividends on or
repurchase our common shares, or make certain acquisitions or investments. In addition, we may be subject to
covenants requiring us to satisfy certain financial tests and ratios, and our ability to satisfy such covenants may be
affected by events outside of our control.

Our officers, directors, and principal shareholders, acting as a group, could significantly influence corporate

actions.

As of December 31, 2020, our officers and directors control approximately 41 percent of our common stock.
Acting together, these shareholders could significantly influence any matter requiring approval by our shareholders,
including the election of directors and the approval of mergers or other business combinations. The interests of this
group may not always coincide with our interests or the interests of other shareholders and may prevent or delay a
change in control. This significant concentration of share ownership may adversely affect the trading price of our

common stock because many investors perceive disadvantages to owning stock in companies with controlling
shareholders.

Research analysts may not continue to provide or initiate coverage of our common stock or may issue

negative reports.

The market for our common stock may be affected by the reports financial analysts publish about us. If one of
the analysts covering us downgrades our stock, its price could decline rapidly and significantly. Securities analysts
covering our common stock may discontinue coverage. A lack of research coverage may adversely affect our
stock’s market price.

RISKS RELATED TO OWNING OUR STOCK

The market price of our common stock may fluctuate substantially.

The price for the shares of our common stock sold in our initial public offering was determined by negotiation
between the representatives of the underwriters and us. This price may not have reflected the market price of our
common stock following our initial public offering. Through March 5, 2021, the closing price of our common stock
since our initial public offering has ranged from a low of $2.77 to a high of $17.05 per share. Moreover, the market
price of our common stock might decline below current levels. In addition, the market price of our common stock is
likely to be highly volatile and may fluctuate substantially. Sales of a substantial number of shares of our common
stock in the public market or the perception that these sales may occur could cause the market price of our common
stock to decline.

The realization of any of the risks described in these “Risk Factors” could have a dramatic and material adverse
impact on the market price of our common stock. In addition, securities class action litigation has often been
instituted against companies whose securities have experienced periods of volatility in market price. Any such
securities litigation brought against us could result in substantial costs and a diversion of management’s attention
and resources, which could negatively impact our business, operating results and financial condition. The recent
COVID-19 pandemic may cause increased risk to our common stock’s liquidity and trading price.

Unstable market conditions may have serious adverse consequences on our business.

Our general business strategy may be adversely affected by unpredictable and unstable market conditions.
While we believe we have adequate capital resources to meet current working capital and capital expenditure
requirements, a radical economic downturn or increase in our expenses could require additional financing on less
than attractive rates or on terms that are dilutive to existing shareholders. Failure to secure any necessary financing
in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial
performance and stock price and could require us to delay or abandon clinical developments plans. There is a risk
that one or more of our current service providers, manufacturers and other partners may encounter difficult
economic circumstances, which would directly affect our ability to attain our operating goals on schedule and on
budget. The equity and lending markets have been and will most likely continue to be negatively impacted for an
unknown period of time due to the COVID-19 pandemic.

We experience costs and regulatory risk as a result of operating as a public company, and our management is
required to devote time to compliance initiatives.

We have and will continue to incur costs as a result of operating as a public company, and our management is
required to devote time to compliance initiatives. As a public company, we have and will continue to incur legal,
accounting and other expenses that we did not incur as a private company. In addition, the Sarbanes-Oxley Act of
2002, or Sarbanes-Oxley Act, Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, and other
rules and regulations subsequently implemented by the SEC and Nasdaq, have imposed various requirements on
public companies, including the establishment and maintenance of effective disclosure and financial controls and
changes in corporate governance practices. These rules and regulations have and will continue to result in legal and
financial compliance costs and render some activities more time-consuming and costly. Despite the internal controls
and procedures put in place to maintain compliance with securities laws and regulations, our employees may still fail
to comply with all SEC disclosure and reporting requirements. Such failure could lead to administrative and civil

penalties, criminal penalties, and private litigation with shareholders. The consequences could have a material effect
on our ability to effectively market our products and operate our business.

The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal controls for financial
reporting and disclosure controls and procedures. In particular, we must perform system and process evaluation and
testing of our internal controls over financial reporting to allow management to report on the effectiveness of our
internal controls over financial reporting. Our testing may reveal deficiencies in our internal controls over financial
reporting that are deemed to be material weaknesses.

Our compliance with Section 404 of the Sarbanes-Oxley Act requires that we incur substantial accounting
expense and expend significant management efforts. Moreover, if we are not able to comply with the requirements
of Section 404 of the Sarbanes-Oxley Act in a timely manner, or if we identify deficiencies in our internal controls
over financial reporting that are deemed to be material weaknesses, the market price of our stock could decline and
we could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities, which would
require additional financial and management resources.

Some provisions of our third amended and restated charter, bylaws and Tennessee law may inhibit potential
acquisition bids that you may consider favorable.

Our corporate documents contain provisions that may enable our board of directors to resist a change in control
of our company even if a change in control were to be considered favorable by you and other shareholders. These
provisions include:

•

The authorization of undesignated preferred stock, the terms of which may be established and shares of
which may be issued without shareholder approval;

Advance notice procedures required for shareholders to nominate candidates for election as directors or
to bring matters before an annual meeting of shareholders;

Limitations on persons authorized to call a special meeting of shareholders;

A staggered board of directors;

A restriction prohibiting shareholders from removing directors without cause;

A requirement that vacancies in directorships are to be filled by a majority of the directors then in
office and the number of directors is to be fixed by the board of directors; and

No cumulative voting.

These and other provisions contained in our third amended and restated charter and bylaws could delay or
discourage transactions involving an actual or potential change in control of us or our management, including
transactions in which our shareholders might otherwise receive a premium for their shares over then current prices,
and may limit the ability of shareholders to remove our current management or approve transactions that our
shareholders may deem to be in their best interests and, therefore, could adversely affect the price of our common
stock.

In addition, we are subject to control share acquisitions provisions and affiliated transaction provisions of the
Tennessee Business Corporation Act, the applications of which may have the effect of delaying or preventing a
merger, takeover or other change in control of us and therefore could discourage attempts to acquire our company.

We have never paid cash dividends on our capital stock.

We have never paid cash dividends on our capital stock. The availability of funds for distributions to
shareholders will depend on our financial performance and assets. Any future decision to declare or pay dividends
will be at the sole discretion of our Board of Directors

DEBT-RELATED RISKS

Our Revolving Credit Agreement impose restrictive and financial covenants on us. Our failure to comply

with these covenants could trigger events that would have a material adverse effect on our business.

Our Revolving Credit Agreement contains covenants that restrict the way we conduct business and require us to
satisfy certain financial tests in order to incur debt or take other actions. Additionally, our Revolving Credit
Agreement contains financial covenants that, for example, require us to maintain certain financial ratios which are
measured at the end of each fiscal quarter.

Our Revolving Credit Agreement contains specified quarterly financial maintenance covenants. As of
December 31, 2020, we were in compliance with the Tangible Capital Ratio financial covenant of the Revolving
Credit Agreement and we expect to maintain compliance with the Tangible Capital Ratio financial covenant in
future periods. However, we can make no assurance that we will be able to comply with the restrictive and financial
covenants contained in the Revolving Credit Agreement in the future.

Our inability to comply with the covenants in our debt instruments could lead to a default or an event of default
under the terms thereof, for which we may need to seek relief from our lender in order to waive the associated
default or event of default and avoid a potential acceleration of the related indebtedness or cross-default or cross-
acceleration to other debt. There can be no assurance that we would be able to obtain such relief on commercially
reasonable terms or otherwise and we may be required to incur significant additional costs. In addition, the lender
under our Revolving Credit Agreement may impose additional operating and financial restrictions on us as a
condition to granting any such waiver. If an event of default is not cured or is not otherwise waived, the lender under
our Revolving Credit Agreement may accelerate the maturity of the related debt, foreclose upon any collateral
securing the debt and terminate any commitments to lend, any of which would have a material adverse effect on our
business, financial condition, cash flows and results of operations and would cause the market value of our securities
to decline.

We have risks related to interest rates.

Our revolving credit facility bears interest based on variable interest. Thus, a change in the short-term interest
rate environment (especially a material change) could have a material adverse effect on our business, financial
condition, cash flows and results of operations. As of December 31, 2020, we did not have any outstanding interest
rate swap contracts.

Item 1B. Unresolved Staff Comments.

None.

Item 2. Properties.

As of December 31, 2020, we leased approximately 25,500 square feet of office space in Nashville, Tennessee
for our corporate headquarters. The lease expires in October 2022. We believe these facilities are adequate to meet
our current needs for office space. Manufacturing, packaging or warehousing services are provided to us through
contracts with third-party organizations.

The laboratory space at CET, under an agreement amended in July 2012, is leased through April 2023, with an
option to extend the lease through April 2028. CET leases approximately 14,200 square feet of office and wet
laboratory space in Nashville, Tennessee to operate the CET Life Sciences Center. Cumberland's product
formulation and testing laboratories are located at this facility, along with CET's offices. The CET Life Sciences
Center also provides laboratory and office space, equipment and infrastructure to early-stage life sciences companies
and university spin-outs.

Item 3. Legal Proceedings.

Please see the discussion of our Acetadote patent defense legal proceedings contained in Part 1, Item 1, Business
-Patents, Trademarks and Other Intellectual Proprietary Rights, of this Form 10-K, which is incorporated by
reference herein.

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.

Market Information

Our common stock, no par value, has been traded on the Nasdaq Global Select Market since August 11, 2009
under the symbol “CPIX.” As of March 8, 2021, we had 77 shareholders of record of our common stock. This
excludes shareholders whose shares are held by brokers and other institutions on behalf of shareholders. The closing
price of our common stock on the Nasdaq Global Select Market on March 8, 2021 was $3.21 per share.

Dividend Policy

We have not declared or paid any cash dividends on our common stock. Any future decision to declare or pay

dividends will be at the sole discretion of our Board of Directors.

Performance Graph

The stock performance graph below illustrates a comparison of the total cumulative stockholder return on our
common stock since December 31, 2015 to the Nasdaq Composite and a composite of seven Nasdaq Pharmaceutical
and Specialty Pharmaceutical Stocks which most closely compare to our Company. The graph assumes an initial
investment of $100 on December 31, 2015, and that all dividends were reinvested.

Purchases of Equity Securities

The Company currently has a share repurchase program to repurchase up to $10.0 million of our common stock
pursuant to Rule 10b-18 of the Securities Act of 1934. In January 2019, the Company's Board of Directors
established the current $10.0 million repurchase program to replace the prior authorizations. We repurchased
503,626 shares, 623,478 shares and 443,041 shares of common stock for approximately $1.8 million, $3.5 million
and $2.9 million, and during the years ended December 31, 2020, 2019 and 2018, respectively.

The following table summarizes the activity, by month, during the fourth quarter of 2020:

Period

Total Number
of Shares (or
Units)
Purchased

October

November

December

Total

38,501

31,162 (1)

26,280

95,943

Average
Price Paid
per Share
(or Unit)

$3.14

$3.02

$3.06

Total Number of
Shares (or Units)
Purchased as
Part of Publicly
Announced Plans or
Programs

Maximum Number (or
Approximate Dollar
Value) of Shares (or
Units) that May Yet Be
Purchased Under the
Plans or Programs

38,501

31,162

26,280

$6,364,741

$6,270,602

$6,190,118

(1) Of this amount, 280 shares were repurchased directly in private purchases at the then-current fair market value of common
stock.

Period EndingIndex ValueCOMPARISON OF CUMULATIVE TOTAL RETURNPeer CompositeCPIXNASDAQ Composite12/31/1512/31/1612/31/1712/31/1812/31/1912/31/20$0$50$100$150$200$250$300

Item 6. Selected Financial Data.

The selected consolidated financial data set forth below should be read in conjunction with the audited consolidated
financial statements and related notes and Item 7, “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” and other financial information appearing elsewhere in this Form 10-K. The historical
results are not necessarily indicative of the results to be expected for any future periods.

Statement of income data:

2020

2019

2018

2017

2016

(in thousands, except per share data)

Years Ended December 31,

Net revenues

Costs and expenses

Operating income (loss)

37,441 $

34,388 $

29,345 $ 26,323 $ 32,187

43,823

(6,382)

43,676

40,518

(9,288)

(11,173)

35,202

(8,879)

33,753

(1,566)

Net income (loss) from continuing
operations
Net income (loss) from discontinued
operations
Net income (loss) attributable to common
shareholders

Earnings (loss) per share:

Continuing operations - basic
Discontinued operations - basic

Earnings (loss) per share – basic

Continuing operations - diluted
Discontinued operations - diluted

Earnings (loss) per share – diluted

(6,626)

(9,212)

(10,821)

(12,848)

(1,137)

3,207

5,665

3,782

4,798

133

(3,339)

(3,538)

(6,963)

(7,979)

(945)

(0.43) $

(0.60) $

(0.69) $

(0.80) $

(0.07)

0.21

(0.22) $

(0.43) $

0.21

0.37

0.24

0.30

(0.23) $

(0.45) $

(0.50) $

(0.60) $

(0.69) $

(0.80) $

0.37

0.24

0.30

0.01

(0.06)

(0.07)

0.01

(0.22) $

(0.23) $

(0.45) $

(0.50) $

(0.06)

Balance sheet data:

2020

2019

2018

2017

2016

(in thousands)

As of December 31,

Cash and cash equivalents

Marketable securities
Working capital

Total assets

Total long-term debt (including current
portion) and other long-term obligations
Retained earnings (deficit)

Total equity

24,754 $

28,213 $ 27,939 $ 45,413 $ 34,510

—

24,302

96,463

23,922

(2,131)

46,873

—

26,013

8,291

31,312

104,549

112,694

29,314

1,208

51,085

29,319

4,746

55,571

4,672

50,990

93,232

11,616

11,709

63,922

15,622

50,753

93,405

5,491

18,605

73,121

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial position and results of operations should be read
together with our audited consolidated financial statements and related notes appearing elsewhere in this Form 10-
K. This discussion and analysis may contain forward-looking statements that involve risks and uncertainties –
please refer to the section entitled, “Special Note Regarding Forward-Looking Statements,” contained in Part I,
Item 1A, “Risk Factors,” of this Form 10-K. You should review the “Risk Factors” section of this Form 10-K for a
discussion of important factors that could cause actual results to differ materially from the results described in or
implied by the forward-looking statements described in the following discussion and analysis.

EXECUTIVE SUMMARY

We are a specialty pharmaceutical company focused on the acquisition, development and commercialization of
branded prescription products. Our primary target markets are hospital acute care, gastroenterology and
rheumatology. These medical specialties are characterized by relatively concentrated prescriber bases that we
believe can be penetrated effectively by small, targeted sales forces. Cumberland is dedicated to providing
innovative products that improve the quality of care for patients and address unmet or poorly met medical needs.
We promote our approved products through our hospital and field sales forces in the United States and are
establishing a network of international partners to bring our medicines to patients in their countries.

Our portfolio of FDA approved brands includes:

•

Acetadote® (acetylcysteine) Injection, for the treatment of acetaminophen poisoning;

Caldolor® (ibuprofen) Injection, for the treatment of pain and fever;

• Kristalose® (lactulose) for Oral Solution, a prescription laxative, for the treatment of chronic

and acute constipation;

• Omeclamox®-Pak,

(omeprazole, clarithromycin, amoxicillin)

for

the

treatment of

Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease;

•

Vaprisol® (conivaptan) Injection, to raise serum sodium levels in hospitalized patients with
euvolemic and hypervolemic hyponatremia;

Vibativ® (telavancin) Injection, for the treatment of certain serious bacterial infections
including hospital-acquired and ventilator-associated bacterial pneumonia, as well as
complicated skin and skin structure infections; and

• RediTrex® (methotrexate) Injection, for the treatment of active rheumatoid, juvenile

idiopathic and severe psoriatic arthritis, as well as disabling psoriasis.

Additionally, we have Phase II clinical programs underway evaluating our ifetroban product candidates in
patients with cardiomyopathy associated with Duchenne Muscular Dystrophy (“DMD”), Systemic Sclerosis
(“SSc”), and Aspirin-Exacerbated Respiratory Disease ("AERD"). We have also completed Phase II clinical
programs with ifetroban in patients with Hepatorenal Syndrome (“HRS”) and patients with Portal Hypertension
(“PH”).

We promote our approved products through our hospital and gastroenterology sales forces in the United States,

which together comprised approximately 40 sales representatives and managers as of December 31, 2020.

We have both product development and commercial capabilities and believe we can leverage our existing
infrastructure to support our expected growth. Our management team consists of pharmaceutical industry veterans
experienced in business development, product development, regulatory, manufacturing, sales marketing and finance.
Our business development team identifies, evaluates and negotiates product acquisition, licensing and co-promotion
opportunities. Our product development team creates proprietary product formulations, manages our clinical studies,
prepares all regulatory submissions and manages our medical call center. Our quality and manufacturing
professionals oversee the manufacture, release and shipment of our products. Our marketing and sales professionals

are responsible for our commercial activities, and we work closely with our distribution partners to ensure
availability and delivery of our products.

The following is a summary of our 2020 highlights and recent developments. For more information, please see

Part I, Item I, Business, of this Form 10-K.

•

Early in 2020, we implemented the national launch of our Next Generation Caldolor product featuring a
ready to use formulation in a pre-mixed bag, offering time and cost savings associated with its
administration.

• We launched several national initiatives during 2020 to help hospitals access our acute care brands during
this healthcare emergency. Our Vibativ product was used to help COVID patients who developed bacterial
infections in their lungs.

• We entered into an agreement with Win Health Pharma and formed WHC Biopharmaceuticals, Pte. Ltd – a
joint venture based in Singapore to acquire, develop and commercialize products for China and adjacent
Asian markets.

• We announced a series of publications featuring important new data associated with our Caldolor and

Vibativ brands.

• We ended the year with the initial introduction of our FDA-approved RediTrex line of injectable

methotrexate products, featuring an innovative delivery system for patients with arthritis.

COVID-19 Pandemic

CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES

Accounting Estimates and Judgments

The preparation of the consolidated financial statements in conformity with GAAP requires management to
make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses
during the period. We base our estimates on past experience and on other factors we deem reasonable given the
circumstances. Past results help form the basis of our judgments about the carrying value of assets and liabilities that
are not determined from other sources. Actual results could differ from these estimates. These estimates, judgments
and assumptions are most critical with respect to our accounting for revenue recognition, marketable securities,
inventory, intangible assets and goodwill, research and development accounting, contingent consideration liability,
provision for income taxes and share-based payments.

Revenue Recognition

We recognize revenue in accordance with the Accounting Standards Codification (ASC) Topic 606. Effective
January 1, 2018, we adopted the Financial Accounting Standards Board’s (“FASB”) amended guidance in the form
of Accounting Standards Update (“ASU”) No. 2014-09, "Revenue from Contracts with Customers," (ASC 606).

Our revenue is derived primarily from the product sales of our FDA approved pharmaceutical brands. Revenue
from sales of products is recognized at the point where the customer obtains control of the goods and we satisfy our
performance obligation, which occurs upon either shipment of the product or arrival at its destination, depending
upon the shipping terms of the transaction. Payment terms typically range from 30 to 60 days from date of shipment.
Our net product revenue reflects the reduction from gross product revenue for estimated allowances for chargebacks,
and discounts and reflects sales related accruals for rebates, coupons, product returns, and certain administrative and
service fees. Significant judgments must be made in determining the transaction price for our sales of products
related to these adjustments. Other revenue, which is a component of net revenues, includes non-refundable upfront
payments and milestone payments under licensing agreements along with grant and rental income. Other income
was approximately 4.3% percent of net revenues in 2020, 5.8% in 2019, and 1.8% in 2018 respectively.

Our financial statements reflect accounts receivable allowances of $1.0 million and $0.8 million at

December 31, 2020 and 2019, respectively, for chargebacks and early pay discounts for products.

The following table reflects our sales-related accrual activity for the periods indicated below:

2020

2019

2018

Balance, January 1

Current provision

4,593,167 $

4,961,631 $

4,140,980

13,453,894

13,081,251

11,192,489

Actual product returns and credits issued

(13,983,626)

(13,449,715)

(10,371,838)

Balance, December 31

4,063,435 $

4,593,167 $

4,961,631

The allowances for chargebacks and discounts and sales related accruals for rebates, fee for service and product
returns are determined on a product-by-product basis. We establish them using our best estimate at the time of sale
based on:

Each product’s historical experience adjusted to reflect known changes in the factors that impact

•
such allowances;

•

The contractual terms with direct and indirect customers;

Analyses of historical levels of chargebacks, discounts and returns of product;

Communications with customers;

Purchased information about the rate of prescriptions being written and the level of inventory

•
remaining in the distribution channel, if known; and

Expectations about the market for each product, including any anticipated introduction of

•
competitive products.

Other organizations, such as managed care providers, pharmacy benefit management companies and
government agencies, may receive rebates from us based on either negotiated contracts to carry our products or
reimbursements for filled prescriptions. These entities are considered our indirect customers. When recognizing a
sale to a wholesaler, sales revenues are reduced and accrued liabilities are increased by our estimate of the rebate
that may be claimed.

The allowances for chargebacks and accruals for rebates and product returns are the most significant estimates
used in the recognition of our revenue from product sales. Of the accounts receivable allowances and our sales
related accruals, our accrual for fee for services and product returns represents the majority of the balance. Sales
related accrued liabilities for rebates, product returns, service fees, and administrative fees totaled $4.1 million, $4.6
million and $5.0 million as of December 31, 2020, 2019 and 2018, respectively. Of these amounts, our estimated
liability for fee for services represented $1.0 million, $1.4 million and $1.8 million, respectively, while our accrual
for product returns totaled $1.7 million, $1.9 million and $1.8 million, respectively. If the actual amount of cash
discounts, chargebacks, rebates, and product returns differs from the amounts estimated by management, material
differences may result from the amount of our revenue recognized from product sales. A change in our rebate
estimate of one percentage point would have impacted net sales by approximately $0.4 million for the years ended
December 31, 2020, 2019 and 2018. A change in our product return estimate of one percentage point would have
impacted net sales by $0.3 million for the years ended December 31, 2020, 2019 and 2018.

Fair Value of Marketable Securities

We have historically invested a portion of our cash reserves in short-term cash investments, U.S. Treasury notes
and bonds, corporate bonds and commercial paper in order to maximize our return on cash. We mark the
investments to fair value at the end of each reporting period, with the adjustment being recognized in the statement
of income as a component of interest income. These investments are generally valued using observable market
prices by third-party pricing services, or are derived from such services' pricing models. The level of management
judgment required in establishing fair value of financial instruments for which there is a quoted price in an active
market is minimal. Similarly, there is little subjectivity or judgment required for instruments valued using valuation
models that are standard across the industry and where all parameter inputs are quoted in active markets. Inputs to
the models may include, but are not limited to, reported trades, executable bid and ask prices, broker/dealer
quotations, prices or yields of securities with similar characteristics, benchmark curves or information pertaining to
the issuer, as well as industry and economic events.

Inventories

We record amounts for estimated obsolescence or unmarketable inventory in an amount equal to the difference
between the cost of inventory and the net realizable value based upon assumptions about remaining shelf life, future
demand and market conditions. The estimated inventory obsolescence amounts are calculated based upon specific
review of the inventory expiration dates and the quantity on-hand at December 31, 2020 in comparison to our
expected inventory usage. The amount of actual inventory obsolescence and unmarketable inventory could differ
(either higher or lower) in the near term from the estimated amounts. Changes in our estimates would be recorded in
our statement of operations in the period of the change.

Income Taxes

We provide for deferred taxes using the asset and liability approach. Under this method, deferred tax assets and
liabilities are recognized for the future tax consequences attributable to operating loss and tax credit carry-forwards
and differences between the financial statement carrying amounts of existing assets and liabilities and their
respective tax bases. Our principal differences are related to the timing of deductibility of certain items such as
depreciation, amortization and expense for options issued to nonemployees. Deferred tax assets and liabilities are
measured using management’s estimate of tax rates expected to apply to taxable income in the years in which
management believes those temporary differences are expected to be recovered or settled. The effect on deferred tax
assets and liabilities of a change in tax rates is recognized in our results of operations in the period that includes the
enactment date.

In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that
some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is
dependent upon the generation of future taxable income during the periods in which those temporary differences
become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable
income and tax planning strategies in making this assessment.

The Company’s accounting policy with respect to interest and penalties arising from income tax settlements is

to recognize them as part of the provision for income taxes.

Share-Based Payments

We recognize compensation expense for all share-based payments based on the fair value of the award on the

date of grant. In addition, incremental compensation expense is recognized upon the modification of equity awards.

We issue restricted stock awards at no cost in lieu of stock options to employees, directors and consultants.
Compensation expense for restricted stock granted to employees and directors is generally equal to the fair market
value of the underlying common stock on the date of grant. If a sufficient disincentive for nonperformance does not
exist at the date of grant, the compensation cost is remeasured at each reporting date at the then-current fair market
value of the underlying common stock until the award vests.

Research and Development

We accrue for and expense research and development costs based on estimates of work performed, patient
enrollment or fixed-fee-for-services. As work is performed and/or invoices are received, we adjust our estimates and
accruals. To date, our accruals have not differed materially from our estimates. Total research and development costs
are a function of studies being conducted and will increase or decrease based on the level of activity in any particular
year.

Intangible Assets and Goodwill

Intangible assets include product rights, license agreements, other identifiable intangible assets and goodwill
associated with the Vibativ acquisition. We assess the impairment of goodwill at least annually. We assess the
impairment of identifiable intangible assets subject to amortization whenever events or changes in circumstances
indicate the carrying value may not be recoverable. In determining the recoverability of our intangible assets, we
make assumptions regarding estimated future cash flows and other factors. If the estimated undiscounted future cash
flows do not exceed the carrying value of the intangible assets, we must determine the fair value of the intangible
assets. If the fair value of the intangible assets is less than the carrying value, an impairment loss will be recognized
in an amount equal to the difference. Fair value is determined through various valuation techniques including quoted
market prices, third-party independent appraisals and discounted cash flow models, as considered necessary.

RESULTS OF OPERATIONS

Year ended December 31, 2020 compared to year ended December 31, 2019

The following table presents the statements of operations for the years ended December 31, 2020 and 2019:

Net revenues

Costs and expenses:

Cost of products sold

Selling and marketing

Research and development

General and administrative

Amortization

Total costs and expenses

Operating income (loss)

Interest income

Interest expense

Income (loss) before income taxes

Income tax (expense) benefit

Net income (loss) from continuing
operations

2020

Years ended December 31,
2019

Change

37,441,134 $

34,388,295 $

3,052,839

8,653,020

14,765,465

5,773,825

10,196,299

4,434,120

43,822,729

7,421,316

15,277,740

6,868,480

9,974,384

4,134,557

43,676,477

(6,381,595)

(9,288,182)

75,345

(263,627)

(6,569,877)

(55,902)

243,364

(246,186)

(9,291,004)

79,316

1,231,704

(512,275)

(1,094,655)

221,915

299,563

146,252

2,906,587

(168,019)

(17,441)

2,721,127

(135,218)

(6,625,779) $

(9,211,688) $

2,585,909

The following table summarizes net revenues for the years presented:

Years ended December 31,

2020

2019

Change

Products:

Kristalose

Vibativ

Caldolor

Acetadote

Omeclamox-Pak
Vaprisol

RediTrex

Other

15,567,562 $

12,895,120 $

10,870,990

5,336,943
1,874,206
257,088
1,077,227

856,657

1,600,461

8,691,550

5,222,282
3,824,449
837,829
936,615

—

1,980,450

Total net revenues

37,441,134 $

34,388,295 $

2,672,442

2,179,440

114,661
(1,950,243)
(580,741)
140,612

856,657

(379,989)

3,052,839

Net revenues. Net revenues for the year ended December 31, 2020 were approximately $37.4 million compared
to $34.4 million for the year ended December 31, 2019, representing an increase of $3.1 million or 8.9%. As
detailed in the table above, net revenue increased during the 2020 for four of our marketed products: Kristalose,
Vibativ, Caldolor and Vaprisol. The improvement was led by largest product, Kristalose which delivered $2.7
million in revenue growth, followed by Vibativ, which delivered an additional $2.2 million during 2020 compared to
2019. Our newest product, RediTrex, contributed $0.9 million in incremental revenue during the year after its late
2020 soft launch.

These increases were partially offset by decreased net product sales of Acetadote and Omeclamox-Pak.

We returned the exclusive rights to commercialize Ethyol and Totect in the United States to Clinigen effective
January 1, 2020. As a result, the 2019 revenues and expenses associated with the products are combined and
reclassified into discontinued operations in our financial statements. In exchange for the return of these product
license rights and associated non-compete provision, Cumberland is receiving $5 million in financial consideration
paid over the two-years following the return date. The first four installments totaling $3.0 million due from Clinigen
was recorded during the year ended December 31, 2020, as discontinued operations. We do not incur expenses
associated with these payments from Clinigen.

Kristalose revenue increased by $2.7 million, or 20.7%, compared to December 31, 2019 primarily as a result of

improved sales volume for the product.

Vibativ revenue was $10.9 million compared to $8.7 million in the prior year. This $2.2 million or 25.1%

increase in net revenue was a result of improved sales volume for the product.

Caldolor revenue experienced a 2.2% increase to $5.3 million during the year ended December 31, 2020
compared to $5.2 million in the same period last year. This increase in Caldolor revenue for the year ended
December 31, 2020 was the result of an increase in international shipments when compared to the prior year, which
were partially offset by lower domestic shipments of the product, significantly impacted by COVID-19 and a
reduction in elective surgeries.

Vaprisol revenue increased $0.1 million during the year ended December 31, 2020 compared to the prior year

period due primarily to increased sales of the product.

Acetadote revenue included net sales of our branded product and our share of net sales from our Authorized
Generic. For the year ended December 31, 2020, the Acetadote net revenue decreased $2.0 million compared to the
prior year due to a reduction in sales volume, primarily impacting the Authorized Generic.

Omeclamox-Pak revenue decreased $0.6 million during the year ended December 31, 2020 compared to the
prior year. The decrease was largely the result of decreased sales volume, which were negatively impacted by
COVID-19.

Cost of products sold. Cost of products sold for the year ended December 31, 2020 were $8.7 million compared
to $7.4 million in the prior year. As a percentage of net revenues, cost of products sold were 23.1% compared to
21.6% during the prior year. This change in costs of products sold as a percentage of revenue was attributable to a
change in the product sales mix, particularly the increase in sales of Vibativ. The Vibativ inventory sold during the
period was acquired and paid for by Cumberland as part of the acquisition of the brand during 2018. The increase in
costs of product sold expense was also the result of a step up in the fair value of the inventory over the cost to
Theravance, as required under purchase accounting rules.

Selling and marketing. Selling and marketing expense for the year ended December 31, 2020 were
$14.8 million compared to $15.3 million in the prior year, which was a decrease of $0.5 million. This decrease was
primarily a result of decreases in direct promotional spending, meeting costs and travel expenses. These decreases
were partially offset by increases in salaries as well as increases in royalty costs associated with growth in Vibativ
sales during the period.

Research and development. Research and development costs for the year ended December 31, 2020 were
$5.8 million, compared to $6.9 million last year, representing a decrease of $1.1 million. A portion of our research
and development costs is variable based on the number of trials, study sites, number of patients and the cost per
patient in each of our clinical programs. We continue to fund our ongoing clinical initiatives associated with our
pipeline products. During 2020, we experienced a decrease in study activity which was partially offset by increases
in our annual FDA user fees.

General and administrative. General and administrative expenses for the year ended December 31, 2020 were
$10.2 million compared to $10.0 million last year. The increase resulted from an increase in legal and professional
fees partially offset by lower stock based compensation during the period. A portion of these increased costs were
for 2019 expenses related to our acquisition of Vibativ.

The components of the statements of operations discussed above reflect the following impacts from Vibativ:

Financial Impact of Vibativ

Net revenue
Cost of products sold (1)
Royalty and operating expenses

Vibativ contribution

Years ended December 31,

2020

2019

10,870,990 $

3,366,198

1,952,449

5,552,343 $

8,691,550

2,716,305

1,609,564

4,365,681

(1) The Vibativ inventory included in the costs of product sold during the period was acquired and paid for by Cumberland as part of the
acquisition of the brand during 2018.

Amortization. Amortization expenses represent the ratable use of our capitalized intangible assets including
product and license rights, patents, trademarks and patent defense costs. Amortization for 2020 totaled
approximately $4.4 million compared to $4.1 million in the prior year, which was an increase of $0.3 million over
the prior year. The increase in expense was attributable to the amortization of additional product rights and
capitalized patents.

Income taxes. Income taxes were an expense of $55,902 for the year ended December 31, 2020 and a benefit of

$79,316 for the year ended December 31, 2019.

Year ended December 31, 2019 compared to year ended December 31, 2018

The following table presents the statements of operations for the years ended December 31, 2019 and 2018:

Net revenues

Costs and expenses:

Cost of products sold

Selling and marketing

Research and development

General and administrative

Amortization

Total costs and expenses

Operating income (loss)

Interest income

Interest expense

Income (loss) before income taxes

Income tax (expense) benefit

Net income (loss) from continuing
operations

2019

Years ended December 31,
2018

Change

34,388,295 $

29,344,894 $

5,043,401

7,421,316

15,277,740

6,868,480

9,974,384

4,134,557

43,676,477

6,016,822

14,004,933

7,575,892

10,150,777

2,769,466

40,517,890

(9,288,182)

(11,172,996)

243,364

(246,186)

564,484

(195,848)

(9,291,004)

(10,804,360)

79,316

(16,636)

1,404,494

1,272,807

(707,412)

(176,393)

1,365,091

3,158,587

1,884,814

(321,120)

(50,338)

1,513,356

95,952

(9,211,688) $

(10,820,996) $

1,609,308

The following table summarizes net revenues for the years presented:

Years ended December 31,

2019

2018

Change

Products:

Kristalose

Vibativ

Caldolor

Acetadote

Omeclamox-Pak

Vaprisol

Other

12,895,120 $

12,055,625 $

8,691,550

5,222,282

3,824,449
837,829
936,615
1,980,450

5,075,057

5,001,997

4,284,111
623,297
1,763,874
540,933

Total net revenues

34,388,295 $

29,344,894 $

839,495

3,616,493

220,285

(459,662)
214,532
(827,259)
1,439,517

5,043,401

Net revenues. Net revenues for the year ended December 31, 2019 were approximately $34.4 million compared
to $29.3 million for the year ended December 31, 2018, representing an increase of $5.0 million or 17.2%. Four of
our products, Omeclamox-Pak, Kristalose, Caldolor and Vibativ, experienced an increase in revenue during 2019.
The 17.2% improvement was led by our newest product, Vibativ, which delivered an additional $3.6 million during
the full year of 2019 compared to a partial year during 2018. These increases were partially offset by decreased net
product sales of Acetadote and Vaprisol.

We returned the exclusive rights to commercialize Ethyol and Totect in the United States to Clinigen effective

January 1, 2020. As a result, the 2019 and 2018 revenues and expenses associated with the products are combined
and reclassified into discontinued operations in our financial statements. In exchange for the return of these product
license rights and associated non-compete provision, Cumberland is receiving $5 million in financial consideration

paid over the two-years following the return date. We do not incur expenses associated with these payments from
Clinigen.

Kristalose revenue increased by $0.8 million, or 7.0%, compared to December 31, 2018 primarily as a result of
increased wholesale prices. The product's net revenue was also positively impacted by lower managed care rebates,
resulting in improved net pricing for the product for the year ended December 31, 2019.

Caldolor revenue experienced a 4.4% increase to $5.2 million during the year ended December 31, 2019
compared to $5.0 million in during 2018. This increase in Caldolor revenue for the year ended December 31, 2019
was the result of an 11% increase in domestic shipments of the product and improved net pricing. The changes were
partially offset by a reduction in international shipments of Caldolor in 2019 over 2018.

Omeclamox-Pak revenue increased $0.2 million or 34.4% during the year ended December 31, 2019 compared
to the prior year. The increase was largely the result of increased sales volume partially offset by higher expired
product sales returns.

Vaprisol revenue decreased $0.8 million during the year ended December 31, 2019 compared to the prior year
period due primarily to decreased sales of the product. The prior year period sales were higher as a result of the
arrival of a new lot of the product during April 2018 resolving temporary supply issues associated with the product.

Acetadote revenue included net sales of our branded product and our share of net sales from our Authorized
Generic. For the year ended December 31, 2019, the Acetadote net revenue decreased $0.5 million or 10.7%
compared to 2018 due to a reduction in sales volume as a result of generic competition.

Cost of products sold. Cost of products sold for the year ended December 31, 2019 were $7.4 million, compared
to $6.0 million during 2018. As a percentage of net revenues, cost of products sold were 21.6% compared to 20.5%
during 2018. The change in costs of products sold as a percentage of revenue was attributable to a change in the
product sales mix during the period compared to 2018.

Selling and marketing. Selling and marketing expense for the year ended December 31, 2019 were $15.3
million, which was an increase of $1.3 million compared to 2018's expense of $14.0 million. This increase was
primarily attributable to promotional spending and sales force costs, including salary and benefits for the increased
sales force. The increase in the sales force and promotional spending is due largely to the addition of our newest
brand, Vibativ, during the fourth quarter of 2018.

Research and development. Research and development costs for the year ended December 31, 2019 were $6.9
million, compared to $7.6 million during 2018, representing a decrease of $0.7 million. A portion of our research
and development costs are variable based on the number of trials, study sites and patients involved in the
development of our product candidates. The decrease was primarily the result of the FDA program fee of $1.3
million paid during 2018 associated with the successful RediTrex FDA submission.

General and administrative. General and administrative expense for the year ended December 31, 2019 was
$10.0 million for 2019, compared to $10.2 million during 2018. The $0.2 million or, 1.7%, decrease from the same
period for 2018 was primarily driven by a decrease in compensation and benefits, including non-cash stock based
compensation and deferred compensation.

Amortization. Amortization expenses represent the ratable use of our capitalized intangible assets including
product and license rights, patents, trademarks and patent defense costs. Amortization for 2019 totaled
approximately $4.1 million, which was an increase of $1.4 million over 2018. The increase in expense was
attributable to the amortization of additional product rights and capitalized patents, including those assets associated
with the Vibativ acquisition.

Income taxes. Income tax benefit for the year ended December 31, 2019 was $79,316. As a percentage of
income (loss) before income taxes, income taxes were a benefit of 0.9% for the year ended December 31, 2019
compared to income tax expense as a percentage of loss before income taxes of 0.2% for the year ended
December 31, 2018.

LIQUIDITY AND CAPITAL RESOURCES

Our primary sources of liquidity are cash flows provided by our operations, the proceeds from the Paycheck
Protection Program loan, the amounts borrowed and available under our line of credit and the cash proceeds from
our initial public offering of common stock that was completed in August 2009. We believe that our internally
generated cash flows, existing working capital and our line of credit will be adequate to finance internal growth,
finance business development initiatives, and fund capital expenditures for the foreseeable future.

We invest a portion of our cash reserves in marketable securities including short-term cash investments, U.S.
Treasury notes and bonds, corporate bonds and commercial paper. At December 31, 2020 and December 31, 2019 ,
all our investments had original maturities of less than ninety days and as a result were classified as cash
equivalents.

The following table summarizes our liquidity and working capital as of the years ended December 31:

Cash and cash equivalents

Marketable securities

2020

2019

24,753,796 $

28,212,635

—

Total cash, cash equivalents and marketable securities

24,753,796 $

28,212,635

Working capital (current assets less current liabilities)

24,302,146 $

26,012,840

Current ratio (multiple of current assets to current liabilities)

1.9

2.1

Revolving line of credit availability

— $

1,500,000

The following table summarizes our net changes in cash and cash equivalents for the years ended December 31:

2020

2019

2018

Cash provided by (used in):

Operating activities

Investing activities

Financing activities

Net (decrease) increase in cash and
cash equivalents

5,415,061 $

3,056,356 $

3,112,737

(1,757,789)

(7,116,111)

2,297,848

(27,724,818)

(5,080,529)

7,138,173

(3,458,839) $

273,675 $

(17,473,908)

The net $3.5 million decrease in cash and cash equivalents for the year ended December 31, 2020 was
attributable to cash used by investing and financing activities partially offset by cash provided by operating
activities. Cash provided by operating activities of $5.4 million included non-cash expense add backs for
depreciation and amortization and share-based compensation expense totaling $5.8 million and changes in our
working capital that provided net cash of $5.4 million. The cash provided by operating activities included $3.5
million provided by discontinued operations. This increase was partially offset by a net loss for the period of $6.6
million. Cash used by investing activities of $1.8 million was the result of additions to intangibles of $2.0 million,
which included the payment of $1.0 million for product rights, additions to property and equipment of $0.1 million
and partially offset by proceeds from the surrender of life insurance of $0.5 million. Our financing activities
included a net repayment of $3.5 million under our line of credit net, $1.9 million in cash used to repurchase shares
of our common stock as well as the $0.8 million used for the repurchase of a portion of CET's shares.

As noted above, we continue to repurchase shares of our common stock, as discussed in Part II, Item 5, "Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities", of this
Form 10-K.

The net $0.3 million increase in cash and cash equivalents for the year ended December 31, 2019 was
attributable to cash provided by operating and investing activities offset by cash used in financing activities. Cash
provided by operating activities of $3.1 million included non-cash expense add backs for depreciation and
amortization and share-based compensation expense totaling $5.9 million. The cash provided by operating activities
included $5.5 million provided by discontinued operations. These increases were partially offset by a net loss for
the period of $3.5 million. Changes in our working capital provided net cash of $1.6 million. Cash provided by
investing activities of $2.3 million included net sales of marketable securities of $8.3 million, partially offset by the
$5 million payment to Theravance as part of the acquisition of Vibativ and the addition to intangibles of $0.8
million. Our financing activities included a net repayment of $1.5 million under our line of credit net and $3.5
million in cash used to repurchase shares of our common stock.

The net $17.5 million decrease in cash and cash equivalents for the year ended December 31, 2018 was
attributable to cash used by investing activities offset by cash provided by operating and financing activities. Cash
provided by operating activities of $3.1 million was impacted by a net loss for the period of $7.0 million. This use of
operating cash was offset by non-cash expenses of depreciation and amortization and share-based compensation
expense totaling $4.3 million. Changes in our working capital provided net cash of $5.2 million. The cash provided
by operating activities included $4.5 million provided by discontinued operations. Cash used in investing activities
included $20 million in cash paid for the acquisition of Vibativ during 2018, the use of cash to complete a net
increase in marketable securities of $3.4 million, and the addition to intangibles of $3.8 million. Our financing
activities included $10.2 million in net cash provided by borrowings under our line of credit net of $2.9 million in
cash used to repurchase shares of our common stock.

Shelf Registration

In November 2017, the Company filed its Shelf Registration on Form S-3 with the SEC associated with the sale
of up to $100 million in corporate securities. The Shelf Registration was declared effective in January 2018. It also
included an At the Market ("ATM") feature that allows the Company to sell common shares at market prices, along
with an agreement with B. Riley FBR Inc. to support such a placement of shares. The Company filed an updated
Form S-3 with the SEC in December 2020, which was declared effective in January 2021. The Company intends to
continue an ATM feature through B. Riley FBR, Inc. that would allow the Company to issue shares of its common
stock. The Company did not issue any shares under this ATM during the year ended December 31, 2020.

Debt Agreement

On October 7, 2020, we entered into a Fourth Amendment (“Fourth Amendment”) to the Revolving Credit
Loan Agreement with Pinnacle Bank (the “Pinnacle Agreement”). The Fourth Amendment extends the maturity date
of the Pinnacle Agreement through October 1, 2022 and provides for a principal available for borrowing of up to
$15 million. We also have the ability to request an increase of up to an additional $5 million, upon the satisfaction
of certain conditions and approval by Pinnacle Bank. If fully expanded, the Fourth Amendment would provide a
maximum principal available for borrowing of up to $20 million. On May 10, 2019, we entered into a third
amendment ("Third Amendment") to the Pinnacle Agreement, which extended the term of the Pinnacle Agreement
through July 31, 2021, as well as modified certain definitions and terms of the existing financial covenants. On
October 17, 2018, we entered into a second amendment (“Second Amendment”) which increased the maximum
aggregate principal available for borrowing under the Pinnacle Agreement to $20.0 million. For a summary of the
material terms of the Pinnacle Agreement, as amended, see Note 9 to the accompanying notes to the consolidated
financial statements.

Under the Pinnacle Agreement, we were initially subject to one financial covenant, the maintenance of a Funded
Debt Ratio. On August 14, 2018, we amended the Pinnacle Agreement ("First Amendment") to replace the single
financial covenant with the maintenance of either the Funded Debt Ratio or a Tangible Capital Ratio, as defined in
the First Amendment. The Third Amendment modified the definition of the Funded Debt Ratio and the compliance
target of the Tangible Capital Ratio. Both Third Amendment modifications were related to the Vibativ transaction.

We were in compliance with the Tangible Capital Ratio financial covenant as of December 31, 2020 and we expect
to maintain compliance with the Tangible Capital Ratio financial covenant in future periods.

Paycheck Protection Program

On April 20, 2020, Cumberland received the funding of a loan from Pinnacle Bank in the aggregate amount of
$2,187,140 pursuant to the Paycheck Protection Program (the “PPP”) under the Federal Coronavirus Aid, Relief,
and Economic Security Act ("CARES Act"), which was enacted March 27, 2020.

We applied for this loan after carefully considering, with our bank, the eligibility criteria to participate in this
program, and determining that Cumberland met these criteria. We evaluated and provided information on our
payroll and other qualifying expenses to determine the amount of PPP funds to apply for.

Cumberland has not laid off or furloughed any employees as a result of the COVID-19 pandemic and, based on
assistance from our PPP loan, we currently do not foresee doing so. In October 2020, we submitted a request for
forgiveness of the PPP loan. The request was approved by the lender, Pinnacle Bank, who then submitted it to the
SBA for the SBA's review and approval.

Minimum Product Purchase Requirements

Our manufacturing and supply agreements do not require minimum annual purchase obligations.

Contractual cash obligations

The following table summarizes our contractual cash obligations as of December 31, 2020:

Payments Due by Year

Contractual obligations(1)

Total

2021

2022

2023

2024

2025 and
thereafter

Line of credit(2)
Estimated interest on
debt (2)
Contingent consideration
liability payments (3)
Operating leases
Purchase obligations (4)

$ 15,000,000 $

— $ 15,000,000 $

— $

782,143

547,500

234,643

—

8,200,553
2,256,680

2,353,789
1,144,889

1,022,014
1,019,313

—

894,555
92,478

—

659,515
—

3,270,680
—

—

Total (1)

$ 26,239,376 $ 4,046,178 $ 17,275,970 $

987,033 $ 659,515 $ 3,270,680

The sum of the individual amounts may not agree due to rounding.

The line of credit payments represent the estimated unused line of credit payments and the amount due at maturity. The
estimated interest on debt represents the interest on the principal outstanding on the line of credit. These amounts are
based on the $15.0 million line of credit assuming the current $15.0 million balance outstanding on December 31, 2020
is consistently outstanding through maturity of October 2022. Interest and unused line of credit payments are due and
payable quarterly in arrears.

The contingent consideration liability represents the fair value of the royalty payments of up to 20% of future net sales
as part of the Vibativ acquisition.

4. Represents minimum purchase obligations under our manufacturing agreements.

OFF-BALANCE SHEET ARRANGEMENTS

During 2020, 2019 and 2018, we did not engage in any off-balance sheet arrangements.

RECENT ACCOUNTING PRONOUNCEMENTS

Recent Adopted Accounting Pronouncements

In November 2018, the FASB issued ASU No. 2018-18, “Collaboration Arrangements: Clarifying the
Interaction between Topic 808 and Topic 606” (ASU 2018-18). The issuance of ASU 2014-09 raised questions
about the interaction between the guidance on collaborative arrangements and revenue recognition. ASU 2018-18
addresses this uncertainty by (1) clarifying that certain transactions between collaborative arrangement participants
should be accounted for as revenue under ASU 2014-09 when the collaboration arrangement participant is a
customer, (2) adding unit of account guidance to assess whether the collaboration arrangement or a part of the
arrangement is with a customer and (3) precluding a company from presenting transactions with collaboration
arrangement participants that are not directly related to sales to third parties together with revenue from contracts
with customers. We adopted the standard effective January 1, 2020 with no impact to our consolidated financial
statements.

In January 2017, the FASB issued ASU No. 2017-04, “Simplifying the Test for Goodwill Impairment” (ASU
2017-04). The guidance removes Step 2 of the goodwill impairment test, which requires a hypothetical purchase
price allocation. As a result of the revised guidance, a goodwill impairment will be the amount by which a reporting
unit's carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. The new standard was
adopted by Cumberland effective January 1, 2020 and was applied prospectively with no impact on our consolidated
financial statements.

Recent Accounting Pronouncements - Not Yet Adopted

In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments-Credit Losses,” which changes the
impairment model for most financial assets and certain other instruments. For trade and other receivables, held-to-
maturity debt securities, loans and other instruments, companies will be required to use a new forward-looking
“expected loss” model that generally will result in the earlier recognition of allowances for losses. For available-for-
sale debt securities with unrealized losses, companies will measure credit losses in a manner similar to what they do
today, except that the losses will be recognized as allowances rather than as reductions in the amortized cost of the
securities. Companies will have to disclose additional information, including information they use to track credit
quality by year of origination for most financing receivables. Companies will apply the ASU’s provisions as a
cumulative-effect adjustment, if any, to retained earnings as of the beginning of the first reporting period in which
the guidance is adopted.

Related to ASU No. 2016-13 discussed above, in May 2019, the FASB issued ASU 2019-05, "Financial
Instruments-Credit Losses (Topic 326): Targeted Transition Relief" which provides transition relief for ASU
2016-13 by providing entities with an alternative to irrevocably electing the fair value option for eligible financial
assets measured at amortized cost upon adoption of the new credit losses standard. Certain eligibility requirements
must be met and the election must be applied on an instrument-by-instrument basis. The election is not available for
either available-for-sale or held-to-maturity debt securities. We will adopt both ASU 2016-13 and ASU 2019-05 on
January 1, 2023. The adoption of ASU 2016-13 and ASU 2019-05 are not expected to have a material impact on the
Company’s consolidated financial statements.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk.

Interest Rate Risk

We are exposed to market risk related to changes in interest rates on our cash on deposit in highly-liquid money
market accounts and revolving credit facility. We do not utilize derivative financial instruments or other market risk-
sensitive instruments to manage exposure to interest rate changes. The main objective of our cash investment
activities is to preserve principal while maximizing interest income through low-risk investments. Our investment
policy focuses on principal preservation and liquidity.

We believe that our interest rate risk related to our cash and cash equivalents is not material. The risk related to
interest rates for these accounts would produce less income than expected if market interest rates fall. Based on
current interest rates, we do not believe we are exposed to significant downside risk related to a change in interest on
our money market accounts. The Company did not have any investments in marketable securities at December 31,
2020.

Based on current interest rates, we do not believe we are exposed to significant downside risk related to change

in interest on our investment accounts.

The interest rate risk related to borrowings under our line of credit is based on LIBOR plus an interest rate
spread. There is no LIBOR minimum and the LIBOR pricing provides for an interest rate spread of 1.75% to 2.75%
(representing an interest rate of 3.65% at December 31, 2020). As of December 31, 2020, we had $15.0 million in
borrowings outstanding under our revolving line of credit.

Exchange Rate Risk

While we operate primarily in the U.S., we are exposed to foreign currency risk. A portion of our research and

development is performed abroad.

Currently, we do not utilize financial instruments to hedge exposure to foreign currency fluctuations. We
believe our exposure to foreign currency fluctuation is minimal as our purchases in foreign currency have a
maximum exposure of 90 days based on invoice terms with a portion of the exposure being limited to 30 days based
on the due date of the invoice. Foreign currency exchange losses were immaterial for 2020, 2019 and 2018. Neither
a five percent increase nor decrease from current exchange rates would have had a material effect on our operating
results or financial condition.

Item 8. Financial Statements and Supplementary Data.

See consolidated financial statements, including the reports of the independent registered public accounting

firm, starting on page F-1, which is incorporated herein by reference.

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.

None.

Item 9A. Controls and Procedures.

Our Chief Executive Officer and Chief Financial Officer, with the participation of other members of
management, have evaluated the effectiveness of our disclosure controls and procedures (as defined Rules 13a-15(e)
and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the year ended December 31, 2020.
Based on such evaluations, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date,
our disclosure controls and procedures were effective (at the reasonable assurance level) to ensure that the
information required to be included in this Annual Report on Form 10-K has been recorded, processed, summarized,
and reported within the time periods specified in the SEC’s rules and forms and to ensure that such information was
accumulated and communicated to management to allow for timely decisions regarding disclosure.

Management’s report on internal control over financial reporting is included on page F-1 of this annual report
on Form 10-K, and incorporated herein by reference. During our fourth quarter of 2020, there were no changes in
our internal control over financial reporting (as defined in Rule 13a-15(f) or 15d-15(f)).

Item 9B. Other Information.

Form 8-K, Item 5.02(e). Compensatory Arrangements of Certain Officers

On March 10, 2021, the Company entered into new employment agreements with each of A.J. Kazimi, our
Chief Executive Officer (the “Kazimi Employment Agreement”), Martin Cearnal, our Executive Vice President and
Chief Commercial Officer (the “Cearnal Employment Agreement”), Leo Pavliv, our Executive Vice President,
Operations and Chief Development Officer (the “Pavliv Employment Agreement”), James Herman, our Senior Vice
President, National Accounts and Chief Compliance Officer (the “Herman Employment Agreement,” and Michael
Bonner, our Senior Director, Finance and Accounting and Chief Financial Officer (the “Bonner Employment
Agreement”), and together with the Kazimi Employment Agreement, the Cearnal Employment Agreement, the
Pavliv Employment Agreement, and the Herman Employment Agreement, the “Employment Agreements”). The
Employment Agreements were effective as of January 1, 2021.

Employment Agreements

Each Employment Agreement provides for a salary for services performed, a potential annual bonus and a grant
of restricted common shares pursuant to a restricted stock agreement. Under the terms of each Employment
Agreement, employment is at-will and may be terminated by the Company at any time, with or without notice and
with or without cause. Similarly, each of Mr. Kazimi, Mr. Cearnal, Mr. Pavliv, Mr. Bonner, and Mr. Herman may
terminate his respective employment with us at any time, with or without notice. The Employment Agreements do
not provide for any severance payments in the event employment is terminated for cause nor any severance benefits
in the event employment is terminated as a result of death or permanent disability. The Employment Agreements
include non-competition, non-solicitation and non-disclosure covenants on the part of employees. The Employment
Agreements impose obligations regarding confidential information and state that any discoveries or improvements
conceived, developed or otherwise made by the employees, or with others, are deemed our sole property. The
Employment Agreements do not contain any termination or change in control provisions.

Kazimi Employment Agreement

Pursuant to the Kazimi Employment Agreement, Mr. Kazimi will serve as the Company’s Chief Executive

Officer and will receive a base salary of $610,132.

The foregoing descriptions of the Kazimi Employment Agreement are qualified in their entirety by reference to
the Kazimi Employment Agreement, which is included as Exhibit 10.11 to this Annual Report on Form 10-K and
are incorporated by reference into this Item. The foregoing description of the Kazimi Employment Agreement does
not purport to be complete and is qualified in its entirety by reference to such exhibit.

Cearnal Employment Agreement

Pursuant to the Cearnal Employment Agreement, Mr. Cearnal will serve as the Company’s Executive Vice

President and Chief Commercial Officer and will receive a base salary of $336,500.

The foregoing descriptions of the Cearnal Employment Agreement are qualified in their entirety by reference to
the Cearnal Employment Agreement, which is included as Exhibit 10.12 to this Annual Report on Form 10-K and
are incorporated by reference into this Item. The foregoing description of the Cearnal Employment Agreement does
not purport to be complete and is qualified in its entirety by reference to such exhibit.

Pavliv Employment Agreement

Pursuant to the Pavliv Employment Agreement, Mr. Pavliv will serve as the Company’s Executive Vice

President, Operations and Chief Development Officer and will receive a base salary of $437,500.

The foregoing descriptions of the Pavliv Employment Agreement are qualified in their entirety by reference to
the Pavliv Employment Agreement, which is included as Exhibit 10.13 to this Annual Report on Form 10-K and are
incorporated by reference into this Item. The foregoing description of the Pavliv Employment Agreement does not
purport to be complete and is qualified in its entirety by reference to such exhibit.

Herman Employment Agreement

Pursuant to the Herman Employment Agreement, Mr. Herman will serve as the Company’s Senior Vice

President, National Accounts and Chief Compliance Officer and will receive a base salary of $270,000.

The foregoing descriptions of the Herman Employment Agreement are qualified in their entirety by reference to
the Herman Employment Agreement, which is included as Exhibit 10.15 to this Annual Report on Form 10-K and
are incorporated by reference into this Item. The foregoing description of the Herman Employment Agreement does
not purport to be complete and is qualified in its entirety by reference to such exhibit.

Bonner Employment Agreement

Pursuant to the Bonner Employment Agreement, Mr. Bonner will serve as the Company’s Senior Director,

Finance and Accounting and Chief Financial Officer and will receive a base salary of $220,000.

The foregoing descriptions of the Bonner Employment Agreement are qualified in their entirety by reference to
the Bonner Employment Agreement, which is included as Exhibit 10.14 to this Annual Report on Form 10-K and
are incorporated by reference into this Item. The foregoing description of the Bonner Employment Agreement does
not purport to be complete and is qualified in its entirety by reference to such exhibit.

PART III

The information called for by Part III of Form 10-K (Item 10 – Directors, Executive Officers and Corporate
Governance, Item 11 – Executive Compensation, Item 12 – Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters, Item 13 – Certain Relationships and Related Transactions, and
Director Independence, Item 14 – Principal Accounting Fees and Services), is incorporated by reference from our
proxy statement related to our 2021 annual meeting of shareholders, which is expected to be filed with the SEC on
or around March 12, 2021.

PART IV

Item 15. Exhibits, Financial Statement Schedules.

a. Documents filed as part of this report:

1. Financial Statements

Management’s Report on Internal Control over Financial Reporting

Report of Independent Registered Public Accounting Firm – Consolidated
Financial Statements

Consolidated Balance Sheets

Consolidated Statements of Operations

Consolidated Statements of Cash Flows

Consolidated Statements of Equity

Notes to the Consolidated Financial Statements

(2)

Financial Statement Schedule

Valuation and Qualifying Accounts

b. Exhibits

Exhibit
Number

Description

Page Number

F-1

F-2

F-5

F-6

F-7

F-9

F-10

F-40

3.1

3.2

4.1

4.2

4.3

4.4

Third Amended and Restated Charter of Cumberland Pharmaceuticals Inc., incorporated
herein by reference to the corresponding exhibit to Amendment No. 19 of the Registrant’s
Registration Statement on Form S-1 (File No. 333-142535) as filed with the SEC on July 17,
2009

Second Amended and Restated Bylaws of Cumberland Pharmaceuticals Inc., incorporated
herein by reference to the corresponding exhibit to Amendment No. 19 of the Registrant’s
Registration Statement on Form S-1 (File No. 333-142535) as filed with the SEC on July 17,
2009

Specimen Common Stock Certificate of Cumberland Pharmaceuticals Inc., incorporated
herein by reference to the corresponding exhibit to Amendment No. 5 of the Registrant’s
Registration Statement on Form S-1 (File No. 333-142535) as filed with the SEC on August 6,
2007

Preferred Stock Terms, Rights, and Provisions, incorporated herein by reference to the
corresponding exhibit to Registrant's Registration Statement Form S-3 (File No. 333-221402)
as filed with the SEC on December 19, 2017

Form of Senior Indenture, incorporated herein by reference to the corresponding exhibit to
Registrant's Registration Statement Form S-3 (File No. 333-221402) as filed with the SEC on
November 7, 2017

Form of Subordinated Indenture, incorporated herein by reference to the corresponding exhibit
to Registrant's Registration Statement Form S-3 (File No. 333-221402) as filed with the SEC
on November 7, 2017

4.5#

4.6.1#

4.6.2#

4.7#

4.8

4.9

4.10

4.11

10.7†

10.7.1†

10.10†

10.11#

10 .12#

10.13#

10.14#

10.15#

Form of Option Agreement under 1999 Stock Option Plan of Cumberland Pharmaceuticals
Inc., incorporated herein by reference to the corresponding exhibit to the Registrant’s
Registration Statement on Form S-1 (File No. 333-142535) as filed with the SEC on May 1,
2007

Form of Incentive Stock Option Agreement under the Amended and Restated 2007 Long-
Term Incentive Compensation Plan of Cumberland Pharmaceuticals Inc. incorporated herein
by reference to the corresponding exhibit to the Registrant’s Annual Report on Form 10-K
(File No. 001-33637) as filed with the SEC on March 12, 2013

Form of Non-Statutory Stock Option Agreement under the Amended and Restated 2007 Long-
Term Incentive Compensation Plan of Cumberland Pharmaceuticals Inc. incorporated herein
by reference to the corresponding exhibit to the Registrant’s Annual Report on Form 10-K
(File No. 001-33637) as filed with the SEC on March 12, 2013

Form of Non-Statutory Stock Option Agreement under the Amended and Restated 2007
Directors’ Compensation Plan of Cumberland Pharmaceuticals Inc. incorporated herein by
reference to the corresponding exhibit to the Registrant’s Annual Report on Form 10-K (File
No. 001-33637) as filed with the SEC on March 12, 2013

Warrant to Purchase Common Stock of Cumberland Pharmaceuticals Inc., issued to Bank of
America, N.A. on July 22, 2009, incorporated herein by reference to the corresponding exhibit
to the Registrant’s Annual Report on Form 10-K (File No. 001-33637) as filed with the SEC
on March 19, 2010

Form of Senior Indenture, incorporated herein by reference to the corresponding exhibit to
Registrant's Registration Statement Form S-3 (File No. 333-184091) as filed with the SEC on
September 25, 2012.

Form of Subordinated Indenture, incorporated herein by reference to the corresponding exhibit
to Registrant's Registration Statement Form S-3 (File No. 333-184091) as filed with the SEC
on September 25, 2012

Description of Cumberland Pharmaceutical's Common Stock

Exclusive Distribution Agreement, effective as of July 1, 2010, by and between Cardinal
Health 105, Inc. and Cumberland Pharmaceuticals Inc., incorporated herein by reference to the
corresponding exhibit of the Registrant’s Current Report on Form 8-K (File No. 001-33637)
as filed with the SEC on August 13, 2010

First Amendment to Exclusive Distribution Agreement, dated March 31, 2013, by and
between Cardinal Health 105, Inc. and Cumberland Pharmaceuticals Inc., incorporated herein
by reference to the corresponding exhibit of the Registrant's Current Report on Form 8-K (File
No. 001-33637) as filed with the SEC on June 3, 2013

License Agreement, dated May 28, 1999, by and between Vanderbilt University and
Cumberland Pharmaceuticals Inc., incorporated herein by reference to the corresponding
exhibit to Amendment No. 3 of the Registrant’s Registration Statement on Form S-1 (File No.
333-142535) as filed with the SEC on July 11, 2007

Employment Agreement dated March 10, 2021, effective as of January 1, 2021, by and
between A.J. Kazimi and Cumberland Pharmaceuticals Inc.

Employment Agreement dated March 10, 2021, effective as of January 1, 2021, by and
between Martin E. Cearnal and Cumberland Pharmaceuticals Inc.

Employment Agreement dated March 10, 2021, effective as of January 1, 2021, by and
between Leo B. Pavliv and Cumberland Pharmaceuticals Inc.

Employment Agreement dated March 10, 2021, effective as of January 1, 2021, by and
between Michael P. Bonner and Cumberland Pharmaceuticals Inc.

Employment Agreement dated March 10, 2021, effective as of January 1, 2021, by and
between James L. Herman and Cumberland Pharmaceuticals Inc.

10.17#

10.18#

10.19#

10.20

10.21†

10.21.1†

10.21.2†

10.21.3†

10.23†

10.24

10.24.1

10.24.2†

1999 Stock Option Plan of Cumberland Pharmaceuticals Inc., incorporated herein by reference
to the corresponding exhibit to the Registrant’s Registration Statement on Form S-1 (File No.
333-142535) as filed with the SEC on May 1, 2007

Amended and Restated 2007 Long-Term Incentive Compensation Plan of Cumberland
Pharmaceuticals Inc., incorporated herein by reference to Appendix A of the Registrant’s
Schedule 14A as filed with the SEC on March 12, 2012 and approved by the Registrant's
shareholders on April 17, 2012

Amended and Restated 2007 Directors’ Incentive Plan of Cumberland Pharmaceuticals Inc.,
incorporated herein by reference to Appendix B of the Registrant's Schedule 14A as filed with
the SEC on March 12, 2012 and approved by the Registrant's shareholders on April 17, 2012

Form of Indemnification Agreement between Cumberland Pharmaceuticals Inc. and all
members of its Board of Directors, incorporated herein by reference to the corresponding
exhibit to the Registrant’s Registration Statement on Form S-1 (File No. 333-142535) as filed
with the SEC on May 1, 2007

Lease Agreement, dated September 10, 2005, by and between Nashville Hines Development,
LLC and Cumberland Pharmaceuticals Inc., incorporated herein by reference to the
corresponding exhibit to Amendment No. 3 of the Registrant’s Registration Statement on
Form S-1 (File No. 333-142535) as filed with the SEC on July 11, 2007

First Amendment to Office Lease Agreement, dated April 25, 2008, by and between 2525
West End, LLC (successor in interest to Nashville Hines Development LLC) and Cumberland
Pharmaceuticals Inc., incorporated herein by reference to the corresponding exhibit to
Amendment No. 10 of the Registrant’s Registration Statement on Form S-1 (File No.
333-142535) as filed with the SEC on May 21, 2008

Second Amendment to Office Lease Agreement, dated March 2, 2010, by and between 2525
West End, LLC (successor in interest to Nashville Hines Development LLC) and Cumberland
Pharmaceuticals Inc., incorporated herein by reference to the corresponding exhibit to the
Registrant’s Quarterly Report on Form 10-Q (File No. 001-33637) as filed with the SEC on
May 17, 2010

Third Amendment to Office Lease Agreement, dated September 29, 2015, by and between
2525 West End, LLC (successor in interest to Nashville Hines Development LLC) and
Cumberland Pharmaceuticals Inc., incorporated herein by reference to the corresponding
exhibit to the Registrant's Quarterly Report on Form 10-Q (File No. 001-33637) as filed with
the SEC on November 6, 2015

Amended and Restated Lease Agreement, dated November 11, 2004, by and between The
Gateway to Nashville LLC and Cumberland Emerging Technologies, Inc., incorporated herein
by reference to the corresponding exhibit to the Registrant’s Registration Statement on Form
S-1 (File No. 333-142535) as filed with the SEC on May 1, 2007

First Amendment to Amended and Restated Lease Agreement, dated August 23, 2005, by and
between The Gateway to Nashville LLC and Cumberland Emerging Technologies, Inc.,
incorporated herein by reference to the corresponding exhibit to the Registrant’s Registration
Statement on Form S-1 (File No. 333-142535) as filed with the SEC on May 1, 2007

Second Amendment to Amended and Restated Lease Agreement, dated January 9, 2006, by
and between The Gateway to Nashville LLC and Cumberland Emerging Technologies, Inc.,
incorporated herein by reference to the corresponding exhibit to Amendment No. 10 of the
Registrant’s Registration Statement on Form S-1 (File No. 333-142535) as filed with the SEC
on May 21, 2008

Third Amendment to Amended and Restated Lease Agreement, dated July 3, 2012, by and
between The Gateway to Nashville LLC and Cumberland Emerging Technologies, Inc.,
incorporated herein by reference to the corresponding exhibit to the Registrant's Quarterly
Report on Form 10-Q (File No. 001-33637) as filed with the SEC on August 9, 2012

10.25†

10.28†

10.30#

10.31†

10.32†

10.34

10.35

10.36

10.37

10.38#

10.39#

10.40

10.41

License and Supply Agreement, dated November 16, 2015, by and between Cumberland
Pharmaceuticals Inc. and Gastro-Entero Logic, LLC incorporated herein by reference to the
corresponding exhibit of the Registrant's Annual Report on Form 10-K (File No. 001-33637)
as filed with the SEC on March 14, 2016

Asset Purchase and Royalty Agreement for Kristalose dated November 15, 2011 by and
between Mylan Inc. and Cumberland Pharmaceuticals Inc., incorporated herein by reference
to the corresponding exhibit of the Registrant’s Current Report on Form 8-K (File No.
001-33637) as filed with the SEC on November 22, 2011

Supplemental Executive Retirement and Savings Plan, incorporated herein by reference to the
corresponding exhibit to the Registrant's Current Report on Form 8-K (File No. 001-33637) as
filed with the SEC on May 24, 2012

Settlement Agreement, dated November 9, 2012, by and between Cumberland
Pharmaceuticals Inc., Paddock Laboratories, LLC and Perrigo Company incorporated herein
by reference to the corresponding exhibit to the Registrant’s Annual Report on Form 10-K
(File No. 001-33637) as filed with the SEC on March 12, 2013

License and Supply Agreement, dated November 9, 2012, by and between Cumberland
Pharmaceuticals Inc., Paddock Laboratories, LLC and Perrigo Company incorporated herein
by reference to the corresponding exhibit to the Registrant’s Annual Report on Form 10-K
(File No. 001-33637) as filed with the SEC on March 12, 2013

Revolving Credit Loan Agreement, dated July 31, 2017, by and between Cumberland
Pharmaceuticals Inc. and Pinnacle Bank incorporated herein by reference to the corresponding
exhibit to the Registrant's Quarterly Report on Form 10-Q (File No. 001-33637) as filed with
the SEC on November 8, 2017

Amendment to Revolving Credit Loan Agreement, by and between Pinnacle Bank and
Cumberland Pharmaceuticals Inc., dated August 14, 2018, incorporated herein by reference to
Exhibit 10.1 to the Registrant's Quarterly Report Form 10-Q (File No. 001-33637) as filed
with the SEC on August 14, 2018

First Amendment to Revolving Credit Note and Second Amendment to Revolving Credit
Loan Agreement, dated as of October 17, 2018, by and between Cumberland Pharmaceuticals
Inc. and Pinnacle Bank, incorporated herein by reference to Exhibit 10.1 to the Registrant's
Current Report on Form 8-K (File No. 001-33637) as filed with the SEC on October 19, 2018

Second Amendment to Revolving Credit Note and Third Amendment to Revolving Credit
Loan Agreement, dated as of May 10, 2019, by and between Cumberland Pharmaceuticals Inc.
and Pinnacle Bank, incorporated herein by reference to Exhibit 10.2 to the Registrant's
Quarterly Report on Form 10-Q (File No. 001-336371) as filed with the SEC on May 15,
2019.

Amendment Number 2 to the Amended and Restated 2007 Long-Term Incentive Plan,
incorporated herein by reference to Exhibit 10.1 of the Registrant’s Quarterly Report on Form
10-Q (File No. 001-33637) as filed with the SEC on August 14, 2020

Amendment Number 2 to the Amended and Restated 2007 Directors’ Incentive Compensation
Plan, incorporated herein by reference to Exhibit 10.2 of the Registrant’s Quarterly Report on
Form 10-Q (File No. 001-33637) as filed with the SEC on August 14, 2020

Payment Protection Program Note dated April 20, 2020, by and between Cumberland
Pharmaceuticals Inc. and Pinnacle Bank, incorporated herein by reference to Exhibit 10.3 of
the Registrant’s Quarterly Report on Form 10-Q (File No. 001-33637) as filed with the SEC
on August 14, 2020

Third Amendment to Revolving Credit Note and Fourth Amendment to Revolving Credit
Loan Agreement, dated as of October 7, 2020, by and between Cumberland Pharmaceuticals
Inc. and Pinnacle Bank, incorporated herein by reference to Exhibit 10.1 of the Registrant’s
Quarterly Report on Form 10-Q (File No. 001-33637) as filed with the SEC on November 13,
2020

23.1

23.2

31.1

31.2

32.1

†

††

Subsidiaries of Cumberland Pharmaceuticals Inc., incorporated herein by reference to the
corresponding exhibit to the Registrant’s Registration Statement on Form S-1 (File No.
333-142535) as filed with the SEC on May 1, 2007

Consent of BDO USA, LLP

Consent of BKD, LLP

Certification of Chief Executive Officer Pursuant to Rule 13-14(a) of the Securities Exchange
Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

Certification of Chief Financial Officer Pursuant to Rule 13-14(a) of the Securities Exchange
Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C.
Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

Indicates a management contract or compensatory plan.

Confidential treatment has been granted for portions of this exhibit. These portions have been
omitted from the Registration Statement and submitted separately to the Securities and
Exchange Commission.

Confidential treatment has been requested for portions of this exhibit. These portions have
been omitted from the Registration Statement and submitted separately to the Securities and
Exchange Commission.

Item 16. Form 10-K Summary

Registrants may voluntarily include a summary of information required by Form 10-K under this Item 16. The

Company has elected not to include such summary information.

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, on March 12, 2021.

Cumberland Pharmaceuticals, Inc.

/s/ A. J. Kazimi

By: A. J. Kazimi

Chief Executive Officer
(Principal Executive 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/ A. J. Kazimi
A. J. Kazimi

/s/ Michael P. Bonner
Michael P. Bonner

/s/ Martin E. Cearnal
Martin E. Cearnal

/s/ Gordon R. Bernard
Gordon R. Bernard

/s/ Jonathan I. Griggs
Jonathan I. Griggs

/s/ James R. Jones
James R. Jones

/s/ Joey A. Jacobs
Joey A. Jacobs

/s/ Caroline R. Young
Caroline R. Young

/s/ Kenneth J. Krogulski
Kenneth J. Krogulski

/s/ Joseph C. Galante
Joseph C. Galante

March 12, 2021

Chairman and CEO
(Principal Executive Officer and
Director)

Senior Director and CFO
(Principal Financial and
Accounting Officer

Director

MANAGEMENT’S REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING

The management of Cumberland Pharmaceuticals Inc. and its subsidiaries (the "Company") is responsible
for establishing and maintaining adequate internal control over financial reporting. Cumberland Pharmaceuticals
Inc.’s internal control system was designed to provide reasonable assurance to the Company’s management and
board of directors regarding the preparation and fair presentation of published financial statements. All internal
control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined
to be effective can provide only reasonable assurance with respect to financial statement preparation and
presentation.

Cumberland Pharmaceuticals Inc.’s management assessed the effectiveness of the Company’s internal control
over financial reporting as of December 31, 2020. In making this assessment, it used the criteria set forth by the
Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control – Integrated
Framework (2013).

Based on its assessment, management has concluded that, as of December 31, 2020, the Company’s internal

control over financial reporting was effective based on those criteria.

/s/ A. J. Kazimi
A. J. Kazimi
Chief Executive Officer
March 12, 2021

/s/ Michael Bonner
Michael Bonner
Chief Financial Officer
March 12, 2021

F-1

Report of Independent Registered Public Accounting Firm

To the Shareholders, Board of Directors and Audit Committee
Cumberland Pharmaceuticals Inc.
Nashville, Tennessee

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Cumberland Pharmaceuticals Inc. (the
“Company”) as of December 31, 2020, and the related consolidated statements of operations, equity, and cash flows
for the year ended December 31, 2020, and the related notes and schedule listed in the accompanying index
(collectively referred to as the “financial statements”). In our opinion, the consolidated financial statements referred
to above present fairly, in all material respects, the financial position of the Company as of December 31, 2020, and
the results of its operations and its cash flows for the year ended December 31, 2020, 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 the Company's financial statements based on our audit.

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 audit 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 audit 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 audit 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 include
examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit
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 audit provide a reasonable basis
for our opinion.

Critical Audit Matters

The critical audit matter communicated below is a matter arising from the current-period audit of the financial
statements that was communicated or required to be communicated to the audit committee and that: (1) relates to
accounts or disclosures that are material to the financial statements and (2) involved our especially challenging,
subjective or complex judgments. The communication of critical audit matters does not alter in any way our opinion
on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below,
providing separate opinions on the critical audit matter or on the accounts or disclosures to which it relates.

Customer Allowances for Chargebacks, Discounts and Damaged Goods and Accruals for Rebates, Coupons,
Product Returns and Certain Fees

As described in Note 2 to the consolidated financial statements, revenues from product sales are recorded net of
estimated allowances for chargebacks, discounts and damaged goods and reflects sales related accruals for rebates,

F-2

coupons, product returns and certain fees. These allowances and accruals are determined on a product-by-product
basis, and are established by management as the Company’s best estimate at the time of sale based on each product’s
historical experience adjusted to reflect known changes in the factors that impact such allowances. Management
reviews these allowances on an ongoing basis and adjusts them based on the most recent information available,
including actual results since the end of the reporting period. As of December 31, 2020, consolidated allowances in
accounts receivable for chargebacks, cash discounts and damaged goods were $1.0 million and consolidated
estimated liability for rebates, coupons, product returns and certain fees were $4.1 million. These provisions are
recognized concurrently with the sales of products. Provisions for chargebacks involve estimates of usage by
retailers and other indirect buyers with varying contract prices for multiple wholesalers. The provision for
chargebacks varies in relation to changes in product mix, pricing and the level of inventory at the wholesalers.
Provisions are calculated using historical chargeback experience, and/or expected chargeback levels for new
products and anticipated pricing changes. Provisions for rebates are recognized based on contractual obligations in
place at the time of sales with consideration given to relevant factors that may affect the payment as well as
historical experience for estimated market activity. Provisions for Medicaid are based on historical trends of rebates
paid, as well as on changes in wholesaler inventory levels, pricing data and increases or decreases in sales.

The principal consideration for our determination that performing procedures relating to these allowances and
accruals is a critical audit matter was the significant judgment by management to estimate the reserves due to the
significant measurement uncertainty involved in developing the reserves. Management tracks the various types of
allowances on several different schedules, each of which relates to different contracts agreed to with various
customers or the interplay with government payors. Management exercises judgment in computing the amount of
sales subject to the allowances and tracks the amount of allowances taken over time. All of this in turn led to a high
degree of auditor judgment, subjectivity and effort in performing procedures and evaluating management’s
significant assumptions.

We identified the estimated sales allowances and accruals as a critical audit matter. The primary procedures we
performed to address this critical audit matter included:

•

Testing the completeness and accuracy of the underlying data used to estimate the accrual by agreeing the
sales data used in the calculation to reports that were reconciled to the financial statements, reconciling the
various allowance percentages to signed customer contracts, tracing the allowance amounts used by the
various customers during the year to supporting documentation and comparing the estimated allowances
from the end of 2019 to actual results that occurred during 2020;

Testing the assumptions used by management in the computation of selected allowances to historical results
for the related products and any recent changes in factors that could influence the future allowances to be
claimed;

Comparing actual allowances reported since December 31, 2020 to the estimated reserves and accruals
recorded on the December 31, 2020 consolidated balance sheet;

Testing the clerical accuracy of the individual customer allowances computed by management and agreeing
the total of all estimated allowances to the respective accounts on the financial statements.

/s/ BKD, LLP

We have served as the Company's auditor since 2020.

Nashville, Tennessee
March 12, 2021

F-3

Report of Independent Registered Public Accounting Firm

Shareholders and Board of Directors
Cumberland Pharmaceuticals Inc.
Nashville, Tennessee

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheets of Cumberland Pharmaceuticals Inc. (the
“Company”) as of December 31, 2019, the related consolidated statements of operations, equity, and cash flows for
each of the two years in the period ended December 31, 2019 and the related notes and financial statement schedule
listed in the accompanying index (collectively referred to as the “consolidated financial statements”). In our opinion,
the consolidated financial statements present fairly, in all material respects, the financial position of the Company at
December 31, 2019, and the results of its operations and its cash flows for each of the two years in the period ended
December 31, 2019, in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is
to express an opinion on the Company’s consolidated 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 consolidated 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 consolidated 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 consolidated 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 consolidated financial statements. We believe that
our audits provide a reasonable basis for our opinion.

/s/ BDO USA, LLP

We served as the Company's auditor from 2017 to 2020.

Nashville, Tennessee
March 20, 2020, except for the effects of presenting discontinued operations as discussed in Note 20, as to which the
date is December 10, 2020.

F-4

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Consolidated Balance Sheets

December 31, 2020 and 2019

ASSETS

Current assets:

Cash and cash equivalents
Accounts receivable, net

Inventories, net

Prepaid and other current assets

Current assets associated with discontinued operations

Total current assets

Non-current inventories

Property and equipment, net

Intangible assets, net

Goodwill

Deferred tax assets, net

Operating lease right-of-use assets

Other assets

Total assets

LIABILITIES AND EQUITY

Current liabilities:

Accounts payable

Operating lease current liabilities

Other current liabilities

Current liabilities associated with discontinued operations

Total current liabilities

Revolving line of credit

Operating lease non-current liabilities

Other long-term liabilities

Total liabilities

Commitments and contingencies

Equity:

Shareholders’ equity:

2020

2019

24,753,796 $

28,212,635

12,377,713

10,638,157

2,199,926

—

49,969,592

11,656,742

574,169

7,859,006

8,871,254

2,757,456

2,462,724

50,163,075

15,554,992

747,796

28,118,316

30,920,324

882,000

—

2,028,148

3,234,338

882,000

21,802

2,960,569

3,298,725

96,463,305 $

104,549,283

13,396,286 $

9,993,578

1,016,779

11,254,381

—

25,667,446

15,000,000

1,059,693
7,862,772

920,431

11,084,869

2,151,357

24,150,235

18,500,000

2,076,472
8,737,323

49,589,911

53,464,030

Common stock – no par value; 100,000,000 shares authorized;
14,988,429 and 15,263,555 shares issued and outstanding as of
December 31, 2020 and 2019, respectively

Retained earnings (deficit)

Total shareholders’ equity

Noncontrolling interests
Total equity

Total liabilities and equity

49,121,523

(2,131,013)

46,990,510

(117,116)

49,914,478

1,208,395

51,122,873

(37,620)

46,873,394

51,085,253

96,463,305 $

104,549,283

See accompanying notes to consolidated financial statements.

F-5

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Consolidated Statements of Operations

Years ended December 31, 2020, 2019 and 2018

Revenues:

Net product revenue

Other revenue

Net revenues

Costs and expenses:

Cost of products sold

Selling and marketing

Research and development

General and administrative

Amortization

Total costs and expenses

Operating income (loss)

Interest income

Interest expense

Income (loss) before income taxes

Income tax (expense) benefit

Net income (loss) from continuing operations

Discontinued operations net of tax

Net income (loss)

2020

2019

2018

$ 35,840,673 $ 32,407,845 $ 28,803,961

1,600,461

1,980,450

540,933

37,441,134

34,388,295

29,344,894

8,653,020

7,421,316

6,016,822

14,765,465

15,277,740

14,004,933

5,773,825

10,196,299

4,434,120

6,868,480

9,974,384

4,134,557

7,575,892

10,150,777

2,769,466

43,822,729

43,676,477

40,517,890

(6,381,595)

(9,288,182)

(11,172,996)

75,345

(263,627)

243,364

(246,186)

564,484

(195,848)

(6,569,877)

(9,291,004)

(10,804,360)

(55,902)

79,316

(16,636)

(6,625,779)

(9,211,688)

(10,820,996)

3,206,875

5,665,177

3,782,224

(3,418,904)

(3,546,511)

(7,038,772)

Net loss at subsidiary attributable to noncontrolling interests

79,496

8,752

75,704

Net income (loss) attributable to common shareholders

(3,339,408) $

(3,537,759) $

(6,963,068)

Earnings (loss) per share attributable to common shareholders:

-Continuing operations-basic

-Discontinued operations-basic

Basic

-Continuing operations-diluted

-Discontinued operations-diluted

Diluted

Weighted-average common shares outstanding:

Basic

Diluted

(0.43) $

(0.60) $

0.21

0.37

(0.22) $

(0.23) $

(0.43) $

(0.60) $

0.21

0.37

(0.22) $

(0.23) $

(0.69)

0.24

(0.45)

(0.69)

0.24

(0.45)

15,162,184

15,396,098

15,614,052

15,162,184

15,396,098

15,614,052

See accompanying notes to consolidated financial statements.

F-6

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Consolidated Statements of Cash Flows

Years ended December 31, 2020, 2019 and 2018

Cash flows from operating activities:

Net income (loss)

Discontinued operations

Net income (loss) from continuing operations

Adjustments to reconcile net income (loss) to net cash flows provided
by operating activities:

Depreciation and amortization expense

Deferred tax expense

Share-based compensation

Excess tax benefit derived from exercise of stock options

Decrease in non-cash contingent consideration

Write off of deferred offering costs

Increase in cash surrender value of life insurance policies over
premiums paid
Noncash interest expense

Noncash investment gains

Net changes in assets and liabilities affecting operating activities:

Accounts receivable

Inventories

Other current assets and other assets

Accounts payable and other current liabilities

Other long-term liabilities

Net cash provided by (used in) operating activities from
continuing operations
Discontinued operations
Net cash provided by operating activities

Cash flows from investing activities:

Additions to property and equipment

Additions to intangible assets

Proceeds from surrender of life insurance policies

Increase in cash surrender value of life insurance policies

Cash paid for acquisition

Proceeds from sale of marketable securities

Purchases of marketable securities

2020

2019

2018

(3,418,904) $

(3,546,511) $

(7,038,772)

3,206,875

5,665,177

3,782,224

(6,625,779)

(9,211,688)

(10,820,996)

4,748,565

4,404,175

2,982,703

21,802

65,408

81,886

1,046,516

1,485,898

1,364,698

—

(81,886)

(1,160,202)

(804,167)

440,091

(154,611)

47,636

—

47,525

(26,315)

99,883

(168,440)

(47,288)

528,153

676,750

(4,518,707)

(1,399,012)

2,131,347

1,210,489

6,569,002

1,106,175

(615,199)

3,221,780

4,153,287

(1,859,330)

(729,820)

(159,558)

1,896,819
3,518,242
5,415,061

(2,455,240)
5,511,596
3,056,356

(1,390,808)
4,503,545
3,112,737

(140,817)

(1,973,110)
460,888

(104,750)

—

(246,202)

(772,944)
—

(455,569)

(3,819,486)
—

—
(5,000,000)

—
(20,000,000)

20,062,132

16,122,376

(11,745,138)

(19,572,139)

Net cash provided by (used in) investing activities

(1,757,789)

2,297,848

(27,724,818)

F-7

Cash flows from financing activities:

Borrowings on line of credit

Payments on line of credit

Sales of shares of common stock, net of offering costs

2020

2019

2018

59,000,000

76,000,000

56,000,000

(62,500,000)

(77,500,000)

(45,800,000)

—

200,909

Payments made in connection with repurchase of common shares

(1,851,526)

(3,494,921)

(2,879,426)

Cash settlement of contingent consideration

Repurchase of subsidiary shares from noncontrolling interest

Sale of subsidiary shares to noncontrolling interest

Payments of deferred equity offering costs

Payments of deferred financing costs

Net cash provided by (used in) financing activities

Net increase (decrease) in cash and cash equivalents

Cash and cash equivalents, beginning of year

Cash and cash equivalents, end of year

(819,180)

(1,033,108)

(800,000)

—

1,000,000

—

(135,405)

(10,000)

—

(383,310)

(52,500)

—

(7,116,111)

(5,080,529)

7,138,173

(3,458,839)

273,675

(17,473,908)

28,212,635

27,938,960

45,412,868

$ 24,753,796 $ 28,212,635 $ 27,938,960

Supplemental disclosure of cash flow information:

Net cash paid (refunded) during the year for:

Interest

Income taxes

Noncash investing and financing activities:

215,991 $

198,661 $

(91,486)

16,694

95,965

15,441

Change in unpaid invoices for intangible asset additions

(340,997) $

(576,837) $

(539,467)

Noncash increase in liabilities related to other asset

200,000

Noncash increase in liabilities related to acquisition (see Note 3)

Recognition of operating lease assets and liabilities through adoption
of ASC 842
Vesting of shares related to RediTrex approval

Repurchase of subsidiary shares from noncontrolling interests

Additions to intangible assets from final purchase price allocation

—

—
—

—

14,034,000

3,629,320

862,200

(800,000)
148,000

—

—
—

See accompanying notes to consolidated financial statements

F-8

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Consolidated Statements of Equity

Years ended December 31, 2020, 2019 and 2018

Cumberland Pharmaceuticals Inc.
Shareholders

Common stock

Amount

Retained
earnings
(deficit)

Non-
controlling
interest

Total equity

Balance, December 31, 2017

15,723,075 $ 52,410,941 $ 11,709,222 $

(198,562) $ 63,921,601

Net income (loss)

—

(6,963,068)

(75,704)

(7,038,772)

Share-based compensation

170,759

1,364,698

Proceeds from sale of
common stock, net of offering
costs
Repurchase of common
shares

30,704

200,909

(443,041)

(2,877,935)

—

1,364,698

—

200,909

(2,877,935)

Balance, December 31, 2018

15,481,497 $ 51,098,613 $ 4,746,154 $

(274,266) $ 55,570,501

—

(3,537,759)

(8,752)

(3,546,511)

Net income (loss)
Repurchase of subsidiary
shares to noncontrolling
interest
Sale of subsidiary shares to
noncontrolling interest

Vesting of common stock

Share-based compensation
Repurchase of common
shares

—

180,000

225,536

(685,805)

640,407

862,200

1,485,898

(623,478)

(3,486,835)

—

(114,195)

(800,000)

359,593

1,000,000

—

862,200

1,485,898

(3,486,835)

Balance, December 31, 2019

15,263,555 $ 49,914,478 $ 1,208,395 $

(37,620) $ 51,085,253

Net income (loss)

Share-based compensation
Repurchase of common
shares

—

(3,339,408)

(79,496)

(3,418,904)

228,500

1,046,516

(503,626)

(1,839,471)

—

1,046,516

(1,839,471)

Balance, December 31, 2020

14,988,429 $ 49,121,523 $ (2,131,013) $

(117,116) $ 46,873,394

See accompanying notes to consolidated financial statements

F-9

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements

(1) Organization

Cumberland Pharmaceuticals Inc. (“Cumberland,” the “Company,” or as used in the context of “we,” “us,” or
“our”) is a specialty pharmaceutical company focused on the acquisition, development and commercialization of
branded prescription products. The Company's primary target markets are hospital acute care, gastroenterology and
rheumatology. These medical specialties are characterized by relatively concentrated prescriber bases that the
Company believes can be penetrated effectively by small, targeted sales forces. Cumberland is dedicated to
providing innovative products that improve quality of care for patients and address unmet or poorly met medical
needs. The Company promotes its approved products through its hospital and field sales forces in the United States
and is establishing a network of international partners to bring its medicines to patients in their countries.

Cumberland focuses its resources on maximizing the commercial potential of its products, as well as developing
new product candidates, and has both internal development and commercial capabilities. The Company’s products
are manufactured by third parties, which are overseen by Cumberland’s quality and manufacturing professionals.
The Company works closely with its third-party distribution partners to make its products available in the United
States.

In order to build a pipeline of early-stage product candidates, the Company formed a subsidiary, Cumberland
Emerging Technologies, Inc. ("CET"), which teams with universities and other research organizations to help
advance scientific discoveries from the laboratory to the marketplace. In 2014, the Company organized equity
financing to recapitalize and strengthen the financial position of CET including an investment of approximately $1.0
million from Gloria Pharmaceuticals Co., Ltd. (“Gloria”). As a result, Gloria received shares in CET and joined the
CET ownership group.

In April, 2019, CET entered into an agreement with HongKong WinHealth Pharma Group Co. Limited
(WinHealth) whereby WinHealth made a $1.0 million investment through the purchase of shares of CET stock. As
part of the agreement, WinHealth obtained a Board position at CET and the first opportunity to license CET
products for the Chinese market. In connection with WinHealth's investment in CET, Cumberland also made an
additional $1.0 million investment in CET. Cumberland purchased additional CET shares through contribution of
$0.3 million in cash and a conversion of $0.7 million in intercompany loans payable. Upon completion of the
additional investment by WinHealth and Cumberland, Gloria Pharmaceuticals returned its shares in CET in
exchange for $0.8 million that was funded during 2020.

The Company's ownership in CET is now 85%. As noted above, the ownership interests of CET includes
WinHealth and Cumberland, while the remaining interest is owned by Vanderbilt University and the Tennessee
Technology Development Corporation. The operating results of CET allocated to noncontrolling interests in the
consolidated statements of operations were $79,496, $8,752 and $75,704 for the years ended December 31, 2020,
2019 and 2018, respectively.

Effective January 1, 2007, the Company formed a wholly-owned subsidiary, Cumberland Pharma Sales Corp.

("CPSC"). CPSC is the subsidiary that employs the Company's hospital and field sales force personnel.

F-10

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

(2) Significant Accounting Policies

Principles of Consolidation

The consolidated financial statements of the Company are stated in U.S. dollars and are prepared using U.S.
generally accepted accounting principles. These financial statements include the accounts of the Company and its
wholly and majority-owned subsidiaries. All significant intercompany transactions and accounts have been
eliminated in consolidation.

COVID-19 Pandemic

In March 2020, the U.S. declared a health care emergency following the outbreak of the (SARS-CoV-2), a

novel strain of coronavirus that causes COVID-19, a respiratory illness.

Cumberland has remained open for business, as the Company is considered to be essential by the United States
Department of Homeland Security. The Company has implemented measures to address the impact of the novel
coronavirus on the business and taken appropriate action to protect the employees, secure the supply chain, and
support the patients who can benefit from its medicines. All of the Company's employees have been given the
opportunity to work remotely, and those that wish to work from Cumberland's office and laboratories are
encouraged to practice the behaviors outlined by the Centers for Disease Control.

Cumberland's sales organization has continued to interact with medical professionals, providing information and
product samples as requested. However, much of their contact has shifted from in person to telephonic and
electronic communications. Travel across the organization and attendance at medical meetings have largely been
discontinued. Cumberland has faced the same headwinds affecting other companies that rely on hospital admissions
and patient visits to drive revenue. During this pandemic, less patients sought care, some patients postponed elective
surgeries and Cumberland's access to medical facilities was substantially limited.

Cumberland relies on third-party organizations around the world to supply components, manufacture and
distribute its products. The Company is aware that it may experience revenue loss, supply interruptions, time delays
and incur unplanned expenses as a result of the impact of the ongoing COVID-19 pandemic. The Company
continues to monitor the COVID-19 pandemic situation both in the U.S. and internationally in order to maintain the
employees’ safety and well-being, while also keeping its business operating. Given the uncertainty, magnitude and
impact of such changes, the Company is unable to quantify the impact on the future results as of the date of this
filing.

Use of Estimates

The preparation of the consolidated financial statements in conformity with U.S. generally accepted accounting
principles requires management of the Company to make estimates and assumptions that affect the reported amounts
of assets and liabilities and disclosure of contingent liabilities at the date of the consolidated financial statements and
the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates
under different assumptions and conditions. The Company's most significant estimates include: (1) its allowances
for chargebacks and accruals for rebates and product returns (2) the allowances for obsolescent or unmarketable
inventory and (3) valuation of contingent consideration liability associated with business combinations.

F-11

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

Segment Reporting

The Company has one operating segment which is specialty pharmaceutical products. Management has chosen
to organize the Company based on the type of products sold. Operating segments are identified as components of an
enterprise about which separate discrete financial information is evaluated by the chief operating decision maker, or
decision-making group, in making decisions regarding resource allocation and assessing performance. The
Company, which uses consolidated financial information in determining how to allocate resources and assess
performance, evaluated that our specialty pharmaceutical products compete in similar economic markets and similar
circumstances. Substantially all of the Company’s assets are located in the United States. Total revenues are
primarily attributable to U.S. customers. Net revenues from customers outside the United States were approximately
$2.4 million, $1.5 million and $2.1 million for the years ended December 31, 2020, 2019 and 2018, respectively.

Fair Value of Financial Instruments

Fair value of financial assets and liabilities is the price the Company would receive to sell an asset or pay to
transfer a liability in an orderly transaction with a market participant at the measurement date. The Company's fair
value measurements follow the appropriate rules as well as the fair value hierarchy that prioritizes the information
used to develop the measurements. It applies whenever other guidance requires (or permits) assets or liabilities to be
measured at fair value and gives the highest priority to unadjusted quoted prices in active markets for identical assets
or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements).

A summary of the fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair

value into three broad levels is described below:

Level 1 - Quoted prices for identical instruments in active markets.

Level 2 - Quoted prices for similar instruments in active markets; quoted prices for identical or
similar instruments in markets that are not active; and model-derived valuations whose inputs are
observable or whose significant value drivers are observable.

Level 3 - Significant inputs to the valuation model are unobservable.

We maintain policies and procedures to value instruments using the best and most relevant data available. The
following section describes the valuation methodologies we use to measure different financial instruments at fair
value on a recurring basis.

The Company’s financial instruments include cash and cash equivalents, accounts receivable, accounts payable,
accrued liabilities, contingent consideration liability and a revolving line of credit. The carrying values for cash and
cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate their fair values due to
their short-term nature. The revolving line of credit has a variable interest rate, which approximates the current
market rate.

The Company's fair values of marketable securities are determined based on valuations provided by a third-
party pricing service, as derived from such services' pricing models, and are considered either Level 1 or Level 2
measurements, depending on the nature of the investment. The Company has no marketable securities in which the
fair value is determined based on Level 3. The level of management judgment required in evaluating fair value for
Level 1 investments is minimal. Similarly, there is little subjectivity or judgment required for Level 2 investments
valued using valuation models that are standard across the industry and whose parameter inputs are quoted in active
markets. Inputs to the models may include, but are not limited to, reported trades, executable bid and ask prices,
broker/dealer quotations, prices or yields of securities with similar characteristics, benchmark curves or information
pertaining to the issuer, as well as industry and economic events. The Company believes that the valuations provided
by the third-party pricing service, as derived from such services' pricing models, represent prices that would be
received to sell the assets at the measurement date (exit prices).

F-12

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

Cash and Cash Equivalents

Cash and cash equivalents include highly liquid investments with original maturities of three months or less. As
of December 31, 2020 and 2019, cash equivalents consist primarily of money market funds as well as trading
securities with original maturities of less than ninety days.

Marketable Securities

The Company invests in marketable debt securities in order to maximize its return on cash. Marketable
securities consist of short-term cash investments, U.S. Treasury notes and bonds, corporate bonds, and commercial
paper. At the time of purchase, the Company classifies marketable securities as either trading securities or available-
for-sale securities, depending on the intent at that time. As of December 31, 2020 and 2019, marketable securities
were comprised solely of trading securities. Trading securities are carried at fair value with unrealized gains and
losses recognized as a component of interest income in the consolidated statements of operations. At December 31,
2020 and December 31, 2019 , all our investments had original maturities of less than ninety days and as a result
were classified as cash equivalents.

Accounts Receivable

Trade accounts receivable are recorded at the invoiced amount. The Company records allowances for amounts
that could become uncollectible in the future based on historical experience, including amounts related to
chargebacks and cash discounts. The Company reviews each customer balance to assess collection status.

The majority of the Company’s products are distributed through independent pharmaceutical wholesalers. The
allowances against accounts receivable for chargebacks and discounts are determined on a product-by-product basis,
and established by management as the Company’s best estimate at the time of sale based on each product’s historical
experience adjusted to reflect known changes in the factors that impact such allowances. These allowances are
established based on the contractual terms with direct and indirect customers and analyses of historical levels of
chargebacks and discounts. The allowances in accounts receivable for chargebacks and cash discounts were $1.0
million at December 31, 2020 and $0.8 million at December 31, 2019.

Other organizations, such as managed care providers, pharmacy benefit management companies and
government agencies, may receive rebates from the Company based on either negotiated contracts to carry the
Company’s products or reimbursements for filled prescriptions. These entities are considered indirect customers of
the Company. In conjunction with recognizing a sale to a wholesaler, revenues are reduced and accrued liabilities
are increased by the Company’s estimate of the rebate that may be claimed. Cash discounts are reductions to
invoiced amounts offered to customers for payment within a specified period of time from the date of the invoice.

Inventories

The Company works closely with third parties to manufacture and package finished goods for sale. Based on
the customer relationship with the manufacturer or packager, the Company will either take title to finished goods at
the time of shipment or at the time of arrival from the manufacturer. The Company then warehouses such goods
until distribution and sale. Inventories are stated at the lower of cost or net realizable value with cost determined
using the first-in, first-out method.

The Company continually evaluates inventories for potential losses due to expired, short-dated or slow-moving
inventory by comparing sales history and sales projections to the inventory on hand. When evidence indicates the
carrying value of a product may not be recoverable, a charge is recorded to reduce the inventory to its current net

F-13

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

realizable value. The Company classifies the Vibativ inventories and ifetroban inventories that it does not expect to
sell within one year as non-current inventories.

Prepaid and Other Current Assets

Prepaid and other current assets consist of deferred offering costs, prepaid insurance premiums, prepaid
consulting services, deposits and annual fees paid to the U.S. Food and Drug Administration ("FDA"). The
Company expenses all prepaid and other current asset amounts as used or over the period of benefit primarily on a
straight-line basis, as applicable.

The Company has recorded deferred offering costs for payments directly related to the current Shelf
Registration on Form S-3 that was completed during December 2020 and declared effective in January 2021. These
costs consist of legal and accounting fees that the Company has capitalized. Deferred costs associated with the Shelf
Registration will be reclassified to additional paid in capital on a pro-rata basis as the Company completes sales of
shares under the Shelf Registration. The Company did not issue any shares under this ATM during the year ended
December 31, 2020. During the year ended December 31, 2020, the Company has expensed $0.4 million in deferred
offering costs associated with the Shelf Registration that was declared effective in January 2018.

Property and Equipment

Property and equipment, including leasehold improvements, are stated at cost. Depreciation is recognized using
the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized over
the shorter of the initial lease term plus renewal options, if reasonably assured, or the remaining useful life of the
asset. Upon retirement or disposal of assets, any gain or loss is reflected as a component of operating income (loss)
in the consolidated statement of operations. Improvements that extend an asset’s useful life are capitalized. Repairs
and maintenance costs are expensed as incurred.

Intangible Assets and Goodwill

The Company’s intangible assets and goodwill consist of capitalized costs related to product and license rights,
patents, trademarks and goodwill obtained in the Vibativ acquisition. Goodwill is not amortized for financial
reporting purposes, but is subject to impairment analysis at least annually.

The cost of acquiring product and license rights are capitalized at fair value at the date of acquisition for
products that are approved by the FDA for commercial use. These costs are amortized ratably over the estimated
economic life of the product. The economic life is estimated based upon several factors. This includes the term of
the license agreement, the patent life or market exclusivity of the product and as well as management's expectations
of continued involvement with the product and the assessment of future sales, the future periods under which the
product will be sold and the profitability of the product. This estimate is evaluated on a regular basis during the
amortization period and adjusted if appropriate. If there are any changes made to the useful life of the product and
license rights, the costs associated with such a change, if any, will be capitalized and amortized over the revised
useful life.

Capitalized patent costs consist of outside legal costs associated with obtaining and protecting patents on
products that have been approved for marketing by the FDA. If it becomes probable that a patent will not be issued
or a patent has been declared invalid, related costs associated with the patent application are expensed at the time

F-14

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

such determination is made. All costs associated with obtaining patents for products that have not been approved for
marketing by the FDA are expensed as incurred.

Amortization expense is recognized ratably over the following periods:

Product rights
License rights
Patents

Estimated economic life
Term of license agreement
Life of patent

Impairment of Long-Lived Assets

Long-lived assets, such as property and equipment, operating lease right-of-use assets and intangible assets
subject to amortization, are reviewed for impairment whenever events or changes in circumstances indicate the
carrying amount of an asset may not be recoverable. If events or circumstances arise that require a long-lived asset
to be tested for potential impairment, the Company first compares undiscounted cash flows expected to be generated
by the asset to its carrying value. If the carrying amount of the long-lived asset is not recoverable on an
undiscounted cash flow basis, an impairment charge is recognized to the extent that the carrying value exceeds the
fair value. Fair value is determined through various valuation techniques including quoted market prices, third-party
independent appraisals and discounted cash flow models.

Goodwill and other indefinite lived intangible assets that are not subject to amortization are tested at least
annually for impairment. The impairment analysis for goodwill requires a comparison of fair value to the carrying
value of the reporting unit. The Company's goodwill was acquired in November 2018 with the Vibativ acquisition.
As a result, the Vibativ component of the Company is the reporting unit evaluated for goodwill impairment.
Cumberland determined the fair value of the reporting unit through current and future estimated revenue and
profitability of the product. The Company recorded no impairment charges during 2020, 2019 and 2018.

Joint Venture Agreement

In August 2020, Cumberland entered into an agreement with WinHealth Investment (Singapore) Ltd creating
WHC Biopharmaceuticals, Pte. Ltd. The joint venture, as a limited liability company, will focus on acquiring,
developing, registering, and commercializing development stage and commercial stage biopharmaceuticals for
China, Hong Kong and other Asian markets. The agreement provides for initial investment from WinHealth in the
form of a $0.2 million equity contribution and an initial investment from Cumberland in the form of $0.2 million
convertible note. The joint venture will seek additional future capital from additional investors and has entered into
exclusive option agreements to license intellectual property from both Cumberland Pharmaceuticals Inc. and
Cumberland Emerging Technologies.

Revenue Recognition

Effective January 1, 2018, the Company adopted the Financial Accounting Standards Board’s (“FASB”)
amended guidance in the form of Accounting Standards Update (“ASU”) No. 2014-09, "Revenue from Contracts
with Customers," (ASC 606).

Net Product Revenue

Revenues from product sales are recognized in the amount that reflects the consideration that we expect to
receive for these goods. Depending upon the shipping terms of the transaction, the revenue is recognized at the
point where the customer obtains control of the goods and we satisfy our performance obligation. This occurs upon
either shipment of the product or arrival at its ship to destination. Payment terms typically range from 30 to 60 days
from date of shipment. The Company’s net product revenue reflects the reduction from gross product revenue for
estimated allowances for chargebacks, discounts and damaged goods, and reflects sales related accruals for rebates,
coupons, product returns, and certain administrative and service fees. Significant judgments must be made in
determining the transaction price for our sales of products related to these adjustments.

F-15

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

Sales Rebates and Discounts

The allowances against accounts receivable and accrued liabilities for chargebacks, discounts, service fees and
expired product returns are determined on a product-by-product basis, and established by management as the
Company’s best estimate at the time of sale based on each product’s historical experience adjusted to reflect known
changes in the factors that impact such allowances. These allowances are established based on the contractual terms
with direct and indirect customers and analyses of historical levels of chargebacks, discounts and returns of expired
product.

Other organizations, such as managed care providers, pharmacy benefit management companies and
government agencies, may receive rebates from the Company based on either negotiated contracts to carry the
Company’s products or reimbursements for filled prescriptions. These entities are considered indirect customers of
the Company. In conjunction with recognizing a sale to a wholesaler, sales revenues are reduced and accrued
liabilities are increased by the Company’s estimate of the rebate that may be claimed.

Sales Returns

Consistent with industry practice, the Company maintains a return policy that allows customers to return
product within a specified period prior to and subsequent to the expiration date. The Company’s estimate of the
provision for returns is based upon historical experience, expiration date by product as well as any other factor
expected to impact future returns. Any changes in the assumptions used to estimate the provision for returns are
recognized in the period those assumptions are changed.

Other Revenues

Other revenues primarily consist of income from grant funding programs, licensing agreements, leases and
contract services. Revenue related to grants is recognized when all conditions related to such grants have been met.
All other revenue is recognized when earned.

Cost of Products Sold

Cost of products sold consists principally of the cost to acquire each unit of product sold, including in-bound
freight expense as well as any adjustment in the net realizable value of inventory acquired in acquisitions. Cost of
products sold also includes expenses associated with the reduction in the net realizable value of slow-moving or
expired product.

Selling and Marketing Expense

Selling and marketing expense consists primarily of expenses relating to the advertising, promotion, distribution

and sale of products, including royalty expense, salaries and related costs.

Distribution Costs

Distribution costs are expensed as incurred and are included as a component of selling and marketing expenses

in the consolidated statements of operations. Distribution costs were as follows for the years ended December 31:

Distribution costs

890,686 $

613,637 $

457,814

2020

2019

2018

F-16

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

Advertising Costs

Advertising costs are expensed as incurred and are included as a component of selling and marketing expenses

in the consolidated statements of operations. Advertising costs were as follows for the years ended December 31:

Advertising costs

2,379,424 $

2,594,630 $

2,005,113

2020

2019

2018

Research and Development

Research and development costs are expensed in the period incurred. Research and development costs are
comprised mainly of clinical trial expenses, salaries, wages and other related costs such as materials and supplies.
Research and development expense includes activities performed by third-party providers participating in the
Company’s clinical studies. The Company accounts for these costs based on estimates of work performed, patients
enrolled or fixed fees for services over the period of time the clinical trials are performed.

Income Taxes

The Company provides for deferred taxes using the asset and liability approach. Under this method, deferred tax
assets and liabilities are recognized for future tax consequences attributable to operating loss and tax credit
carryforwards, as well as differences between the carrying amounts of existing assets and liabilities and their
respective tax bases. The Company’s principal differences are related to the timing of deductibility of certain items,
such as inventory, depreciation, amortization and share-based compensation. Deferred tax assets and liabilities are
measured using enacted statutory tax rates that are expected to apply to taxable income in the years such temporary
differences are anticipated to be recovered or settled. The effect on deferred tax assets and liabilities of a change in
tax rates is recognized in income in the period of enactment. The Company only recognizes income tax benefits
associated with an income tax position in which it is “more likely than not” that the position would be sustained
upon examination by the taxing authorities.

In assessing the realizability of deferred tax assets, management considers whether some portion or all of the
deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the
generation of future taxable income during the periods in which those temporary differences become deductible.
Management considers the scheduled reversal of existing temporary differences, projected future taxable income and
tax planning strategies in making this assessment.

The Company’s accounting policy with respect to interest and penalties arising from income tax settlements is

to recognize them as part of the provision for income taxes.

Earnings (Loss) per Share

Basic earnings (loss) per share is calculated by dividing net income (loss) attributable to common shareholders
by the weighted-average number of shares outstanding. Except where the result would be antidilutive to income
from continuing operations, diluted earnings (loss) per share is calculated by assuming the vesting of unvested
restricted stock and the exercise of stock options and warrants and unrecognized compensation costs.

Share-Based Payments

The Company recognizes compensation cost for all share-based payments issued, modified, repurchased or
canceled. Depending on the nature of the vesting provisions, restricted stock awards are measured using either the
fair value on the grant date or the fair value of common stock on the date the vesting provisions lapse. Prior to the
lapse for those equity grants not valued on the grant date, the fair value is measured on the last day of the reporting
period.

F-17

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

Collaborative Agreements

The Cumberland is a party to several collaborative arrangements with research institutions to identify and
pursue promising pharmaceutical product candidates. The funding for these programs is primarily provided through
Federal Small Business Administration (SBIR/STTR) and other grant awards. The Company has determined that
these collaborative agreements, with the exception of the collaborative payment discussed in Note 3 do not meet the
criteria for accounting under ASC Topic 808, Collaborative Agreements. The agreements do not specifically
designate each party’s rights and obligations to each other under the collaborative arrangements. Except for patent
defense costs, expenses incurred by one party are not required to be reimbursed by the other party. Expenses
incurred under these collaborative agreements are included in research and development expenses and funding
received from grants are recorded as net revenues in the condensed consolidated statements of operations.

Discontinued Operations

As discussed further in Note 20, during May 2019, Cumberland entered into a Dissolution Agreement
("Dissolution Agreement") with Clinigen Healthcare Limited ("Clinigen") in which the Company returned the
exclusive rights to commercialize Ethyol® and Totect® in the United States to Clinigen. Under the terms of the
Dissolution Agreement, Cumberland is no longer involved directly or indirectly with the distribution, marketing and
promotion of either Ethyol or Totect or any competing products following December 31, 2019. The Company's exit
from the products meets the accounting criteria to be reported as discontinued operations and the discontinued
operating results have been reclassified in the financial statements and footnotes for all periods presented to reflect
the discontinued status of these products. Refer to Note 20, for additional information.

Recent Accounting Guidance

Recent Adopted Accounting Pronouncements

In November 2018, the FASB issued ASU No. 2018-18, “Collaboration Arrangements: Clarifying the
Interaction between Topic 808 and Topic 606” (ASU 2018-18). The issuance of ASU 2014-09 raised questions
about the interaction between the guidance on collaborative arrangements and revenue recognition. ASU 2018-18
addresses this uncertainty by (1) clarifying that certain transactions between collaborative arrangement participants
should be accounted for as revenue under ASU 2014-09 when the collaboration arrangement participant is a
customer, (2) adding unit of account guidance to assess whether the collaboration arrangement or a part of the
arrangement is with a customer and (3) precluding a company from presenting transactions with collaboration
arrangement participants that are not directly related to sales to third parties together with revenue from contracts
with customers. Cumberland adopted the standard effective January 1, 2020 with no impact on the Company's
consolidated financial statements.

Recent Accounting Pronouncements - Not Yet Adopted

F-18

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

cumulative-effect adjustment, if any, to retained earnings as of the beginning of the first reporting period in which
the guidance is adopted.

Related to ASU No. 2016-13 discussed above, in May 2019, the FASB issued ASU 2019-05, "Financial
Instruments-Credit Losses (Topic 326): Targeted Transition Relief" which provides transition relief for ASU
2016-13 by providing entities with an alternative to irrevocably electing the fair value option for eligible financial
assets measured at amortized cost upon adoption of the new credit losses standard. Certain eligibility requirements
must be met and the election must be applied on an instrument-by-instrument basis. The election is not available for
either available-for-sale or held-to-maturity debt securities. The Company will adopt both ASU 2016-13 and ASU
2019-05 on January 1, 2023. The adoption of ASU 2016-13 and ASU 2019-05 are not expected to have a material
impact on the Company’s consolidated financial statements.

(3)

RediTrex® and Vibativ®

RediTrex

In November 2016, the Company announced an agreement with the Nordic Group B.V. ("Nordic") to acquire
the exclusive U.S. rights to Nordic’s injectable methotrexate product line designed for the treatment of active
rheumatoid arthritis, juvenile idiopathic arthritis, severe psoriatic arthritis, and severe disabling psoriasis.

As consideration for the license Cumberland paid a deposit of $100,000 at closing. The Company provided
$0.9 million in consideration through a grant of 180,000 restricted shares of Cumberland common stock to be vested
upon the FDA approval of the first Nordic product. Cumberland also agreed to provide Nordic a series of payments
tied to the products’ FDA approval, launch and achievement of certain sales milestones. Under the terms of the
agreement, Cumberland is responsible for the product registration and commercialization in the U.S. Nordic is
responsible for product manufacturing and supply.

On November 27, 2019, Cumberland received FDA approval for the first Nordic injectible product and
authorization to market them under the RediTrex brand name. The 180,000 shares of restricted Cumberland
common stock previously provided to Nordic vested upon approval and were valued at $0.9 million on the vesting
date. The FDA approval also resulted in a $1.0 million milestone payment due to Nordic. This milestone payment
was paid in July 2020 and was recorded as an other current liability at December 31, 2019. During December 2020
Cumberland launched RediTrex and the launch also resulted in a $1.0 million milestone payment due to Nordic.
This milestone payment will be paid during 2021 and was recorded as an other current liability at December 31,
2020.

Cumberland has approximately $2.8 million in net intangible assets related to RediTrex at December 31, 2020.

During 2020, Cumberland recognized $0.5 million of other revenue in its condensed consolidated statement of

operations for a collaborative payment due from Nordic. The payment was received during July 2020.

Vibativ

During November 2018, the Company closed on an agreement with Theravance Biopharma ("Theravance") to
acquire the global responsibility for Vibativ including the marketing, distribution, manufacturing and regulatory
activities associated with the brand. Vibativ is a patented, FDA approved injectable anti-infective for the treatment
of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia and
complicated skin and skin structure infections. It addresses a range of Gram-positive bacterial pathogens, including
those that are considered difficult-to-treat and multidrug-resistant. Cumberland acquired Vibativ to further add to its
product offerings, increase its net revenue and positively contribute to the Company's operating results. Cumberland
expects to deduct the goodwill acquired in the acquisition for tax purposes.

Cumberland has accounted for the transaction as a business combination in accordance with ASC 805 and the
product sales are included in the results of operations subsequent to the acquisition date. The Company paid an
upfront payment of $20.0 million at closing and a $5.0 million cash payment during early 2019. In addition,

F-19

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

Cumberland agreed to pay a royalty of up to 20% on future net sales of the product. The future royalty payments
were required to be recognized at their acquisition-date fair value as part of the contingent consideration transferred
in the business combination.

The following table summarizes the initial payments and consideration for the business combination:

Consideration:

Cash paid at closing

Cash payment during early 2019

Fair value of contingent consideration - net sales royalty

Total consideration

20,000,000

5,000,000

9,182,000

34,182,000

The contingent consideration liability represents the future net sales royalty payments discussed above.
Cumberland prepared the valuations of the contingent consideration liability and the intangible assets utilizing
significant unobservable inputs. As a result, the valuations are classified as Level 3 fair value measurements.

The following table presents the changes in the Company's Level 3 contingent consideration liability that is
remeasured at fair value on a recurring basis. The contingent consideration earned and accrued in operating
expenses is paid to the seller quarterly.

Balance at November 12, 2018

Change in fair value of contingent consideration included in operating expenses

Contingent consideration earned and accrued in operating expenses

Balance at December 31, 2018

Adjustment to initial fair value of the contingent consideration liability

Cash payment of royalty during the period

Change in fair value of contingent consideration included in operating expenses

Contingent consideration earned and accrued in operating expenses

Balance at December 31, 2019

Cash payment of royalty during the period

Change in fair value of contingent consideration included in operating expenses
Contingent consideration earned and accrued in operating expenses

Balance at December 31, 2020

Contingent
consideration liability
9,034,000
$

(40,000)

508,000

9,502,000

148,000

(1,033,108)

(804,167)

820,864

8,633,589
(819,180)
(1,160,202)
1,546,346

8,200,553

F-20

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

The following table summarizes the allocation of the fair values of the assets acquired as of the acquisition date

for Vibativ:

Finished goods inventory

Work in process - unlabeled vials

Work in process - validation vials

Raw materials

Total inventory

Intellectual property amortizable intangible assets

Goodwill

Total intangibles and goodwill

Total assets acquired

6,624,000

3,970,000

1,827,000

9,129,000

21,550,000

11,750,000

882,000

12,632,000

34,182,000

The Company's contingent consideration liability is a Level 3 fair value measurement that is updated on a
recurring basis at each reporting period using a valuation model. Consistent with Level 3 fair value
measurements, there are significant inputs to the valuation model that are unobservable. The current portion of
the contingent consideration liability is $3.3 million and the non-current portion is $4.9 million, as of
December 31, 2020.

(4)

Revenues

Product Revenues

The Company’s net product revenues consisted of the following for the years ended December 31:

Products:

Kristalose

Vibativ

Caldolor

Acetadote

Omeclamox-Pak

Vaprisol
RediTrex

2020

2019

2018

15,567,562 $

12,895,120 $

12,055,625

10,870,990

5,336,943

1,874,206
257,088
1,077,227
856,657

8,691,550

5,222,282

3,824,449
837,829
936,615
—

5,075,057

5,001,997

4,284,111
623,297
1,763,874
—

Total net product revenues

35,840,673 $

32,407,845 $

28,803,961

Other Revenues

During 2019, Cumberland executed a License and Distribution agreement with HongKong WinHealth Pharma
Group Co. Limited (“WinHealth”) for our Caldolor and Acetadote brands in China and Hong Kong. In conjunction
with these new arrangements, the Company terminated a previous License and Distribution agreement with Gloria
Pharmaceuticals Co ("Gloria Pharmaceuticals") for the two brands. In addition, we also signed a new License and
Distribution agreement with DB Pharm Korea Co., Ltd. (“DB Pharm”) for Vibativ in South Korea. As a result of
these agreements, Cumberland recognized approximately $0.3 million of non-refundable up-front payments as other
revenue in the consolidated statement of operations during 2019. There were no payments received in 2020.

F-21

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

The Company has agreements with international partners for commercialization of the Company's products
with associated payments included in other revenues. Those agreements provide that each of the partners are
responsible for seeking regulatory approvals for the product, and following approval, each partner will be
responsible for the ongoing distribution and sales in the respective international territories. The Company provides a
dossier for product registration and maintains responsibility for the relevant intellectual property. Cumberland is
typically entitled to receive a non-refundable, up-front payment at the time each agreement is executed as
consideration for the product dossier and for the rights to the distinct intellectual property rights in the respective
international territory. These agreements also typically provide for additional payments upon a partner’s
achievement of a defined regulatory approval and sales milestones. The Company may also be entitled to receive
royalties on future sales of the products and a transfer price on supplies. The contractual payments associated with
the partner’s achievement of regulatory approvals, sales milestones and royalties on future sales are recognized as
revenue upon occurrence, or at such time that the Company has a high degree of confidence that the revenue would
not be reversed in a subsequent period.

The international agreements provide for $1.0 million in non-refundable up-front payments, milestone payments
of up to $2.2 million related to regulatory approvals and up to $4.8 million in payments related to product sales.
From 2012 through December 31, 2020, the Company has recognized a cumulative $1.2 million in upfront payments
as other revenue and has recognized $0.1 million in revenue related to the milestone payments associated with these
international agreements.

Other revenues during 2020, 2019 and 2018 also include funding from federal grant programs including those
secured by CET through the Small Business Administration as well as lease income generated by CET’s Life
Sciences Center. The Life Sciences Center is a research center that provides scientists with access to flexible lab
space and other resources to develop biomedical products. Grant revenue from these programs totaled approximately
$0.8 million, $1.3 million, and $0.1 million for the years ending December 31, 2020, 2019 and 2018, respectively.

(5)

Inventories

The Company's net inventories consisted of the following as of December 31:

Raw materials and work in process

16,223,162 $

19,345,723

2020

2019

Consigned inventory

Finished goods, net of reserve

Total inventories

less non-current inventories

Total inventories classified as current

128,005

416,468

5,943,732
22,294,899
(11,656,742)
10,638,157 $

4,664,055
24,426,246
(15,554,992)
8,871,254

The Company works closely with third parties to manufacture and package finished goods for sale. Based on
the arrangements with the manufacturer or packager, the Company will either take title to the finished goods at the
time of shipment or at the time of arrival at the Company’s warehouses. The Company then holds such goods in
inventory until distribution and sale. These finished goods inventories are stated at the lower of cost or net realizable
value with cost determined using the first-in, first-out method.

The Company continually evaluates inventory for potential losses due to excess, obsolete or slow-moving goods
by comparing sales history and projections to the inventory on hand. When evidence indicates that the carrying
value may not be recoverable, a charge is taken to reduce the inventory to its current net realizable value. At
December 31, 2020 and 2019 the Company had recognized and maintained cumulative net realizable value charges
for potential obsolescence and discontinuance losses of approximately $0.2 million and $0.1 million, respectively.

F-22

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

In connection with the acquisition of certain product rights related to the Kristalose brand, the Company is
responsible for the purchase of the active pharmaceutical ingredient ("API") for Kristalose and maintains the
inventory at the third-party packagers. As the API is consumed in production, the value of the API is transferred
from raw materials to finished goods. API for the Company's Vaprisol brand is also included in the raw materials
inventory total at December 31, 2020 and 2019. Consigned inventory represents Authorized Generic inventory
stored with Perrigo until shipment.

As part of the Vibativ acquisition, Cumberland acquired API and work in process inventories of $15.6 million
that were classified as non-current inventories. At December 31, 2020, the Vibativ non-current inventory was $11.2
million and $15.3 million at December 31, 2019. The Company had Vibativ finished goods included in the non-
current inventories at December 31, 2020 of $2.1 million and we did not have any Vibativ finished goods included
at December 31, 2019. At December 31, 2020 and December 31, 2019, Cumberland had $0.4 million and $0.3
million, respectively, in non-current inventory for API related to its ifetroban clinical initiatives.

(6)

Property and Equipment

Property and equipment consisted of the following at December 31:

Computer equipment

Office equipment

Furniture and fixtures

Leasehold improvements
Total property and
equipment, gross

Less: accumulated depreciation
and amortization

Total property and
equipment, net

Range of
useful lives

3 – 5 years

3 – 15 years

5 – 15 years
3 – 15 years, or

2020

2019

1,275,703 $

1,260,630

806,906

638,903

878,350

646,505

remaining lease term

1,409,744

1,356,640

4,131,256

4,142,125

(3,557,087)

(3,394,329)

574,169 $

747,796

Depreciation expense, including amortization expense related to leasehold improvements, is included in general
and administrative expense in the consolidated statements of operations. Depreciation expense was as follows for
the years ended December 31:

Depreciation expense

314,444 $

269,619 $

213,237

2020

2019

2018

F-23

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

(7)

Intangible Assets and Goodwill

Intangible assets and Goodwill consisted of the following at December 31:

Product and license rights

Less: accumulated amortization

Total product and license rights

Patents

Less: accumulated amortization

Total patents

Trademarks

Less: accumulated amortization

Total trademarks

Total intangible assets

Goodwill

2020

2019

38,543,542 $

37,400,742

(14,709,824)

(11,499,141)

23,833,718

10,306,922

25,901,601

9,882,511

(6,312,460)

(5,127,878)

3,994,462

338,011

(47,875)

290,136

4,754,633

273,110

(9,020)

264,090

28,118,316 $

30,920,324

882,000 $

882,000

Product and license rights include assets associated with the Company's acquired products, including those
discussed in Note 3, RediTrex and Vibativ. In November 2016, the Company acquired the U.S. rights to Nordic
Group B.V.’s injectable methotrexate product line as an asset purchase. The agreement requires the Company to
provide unvested restricted shares of Cumberland common stock and make a series of payments tied to the products’
FDA approval, launch and achievement of certain sales milestones. The payments are being treated as consideration
for the assets acquired and are being capitalized and amortized over the expected useful life of the acquired asset. To
date, the intangible assets related to the product include the $100,000 deposit paid at closing, the 180,000 restricted
shares valued at $0.9 million that vested upon the November 2019 FDA approval, the additional $1.0 million paid to
Nordic during 2020 based on the 2019 FDA approval and the $1.0 million owed to Nordic based on the 2020
product launch.

As discussed in Note 3, during November 2018, the Company acquired Vibativ from Theravance. This resulted
in amortizable intangible assets related to the product rights of $11.8 million and goodwill of $0.9 million. The
intangible assets are being amortized through November 2028, the expected useful life of the acquired asset. The
$0.1 million increase in goodwill during 2019 was a result of changes in the purchase price allocation during the
measurement period.

During 2020 and 2019, the Company recorded an additional $0.5 million and $0.7 million, respectively, in
intangible assets for patents, trademarks and capitalized patent costs, including amounts incurred in the protection of
the Company's intellectual property. These costs will be amortized over the remaining expected useful life of the
associated patents.

Amortization expense related to product and license rights, trademarks and patents were as follows for the years

ended December 31:

Amortization expense

4,434,120 $

4,134,557 $

2,769,466

2020

2019

2018

F-24

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

The expected amortization expense for the Company's current balance of intangible assets are as follows:

Year ending December 31:

2021
2022
2023
2024
2025 and thereafter

4,338,247
3,691,293
3,629,001
3,629,001
12,830,774
28,118,316

(8)

Other Current and Other Long-term Liabilities

Other current liabilities consisted of the following at December 31:

Other current liabilities

2020

2019

Rebates, product returns, administrative fees
and service fees
Employee wages and benefits

Current portion of accrued contingent consideration

Accrued inventory purchases

Accrued payment for asset purchase

Paycheck Protection Program liability

Other

4,072,151 $

4,593,167

998,064

2,787,741

294,000

—

2,187,140

915,285

1,295,905

2,374,776

829,047

1,000,000

—

991,974

Total other current liabilities

11,254,381 $

11,084,869

Other long-term liabilities

Non-current portion of accrued contingent consideration

Deferred compensation

Other

Total other long-term liabilities

2020

2019

4,855,363 $
2,702,772

304,637
7,862,772 $

6,258,813
2,278,164

200,346
8,737,323

F-25

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

(9)

Debt

On October 7, 2020, the Company entered into a Third Amendment to the Revolving Credit Note and Fourth
Amendment (“Fourth Amendment”) to the Revolving Credit Loan Agreement with Pinnacle Bank (the “Pinnacle
Agreement”). The original Pinnacle Agreement was dated July 2017. The Fourth Amendment provides for a
principal available for borrowing of up to $15 million and Cumberland has the ability to request an increase of up to
an additional $5 million, upon the satisfaction of certain conditions and approval by Pinnacle Bank. If fully
expanded, the Fourth Amendment would provide a maximum principal available for borrowing of up to $20 million,
which was also the maximum aggregate principal available for borrowing under the previously amended Pinnacle
Agreement. The Fourth Amendment extends the maturity date of the Pinnacle Agreement through October 1, 2022.

On May 10, 2019, the Company entered into a third amendment ("Third Amendment") to the Pinnacle
Agreement, which extended the term of the Pinnacle Agreement through July 31, 2021 as well as modified certain
definitions and terms of the existing financial covenants, including the definition of the Funded Debt Ratio and the
compliance target of the Tangible Capital Ratio. Both Third Amendment modifications were related to the Vibativ
transaction. Under the Pinnacle Agreement, Cumberland was initially subject to one financial covenant, the
maintenance of a Funded Debt Ratio, as such term is defined in the agreement and determined on a quarterly basis.
On August 14, 2018, the Company amended the Pinnacle Agreement ("First Amendment") to replace the single
financial covenant with the maintenance of either the Funded Debt Ratio or a Tangible Capital Ratio, as defined in
the First Amendment. The Company was in compliance with the Tangible Capital Ratio financial covenant as of
December 31, 2020.

The initial revolving line of credit under the Pinnacle Agreement was for up to an aggregate principal amount of
$12.0 million with the ability to increase the principal amount available for borrowing up to $20.0 million, upon the
satisfaction of certain conditions. On October 17, 2018, the Company entered into a second amendment (“Second
Amendment”) which increased the maximum aggregate principal available for borrowing under the Pinnacle
Agreement to $20.0 million.

The Company had $15.0 million in borrowings under the Pinnacle Agreement at December 31, 2020 and $18.5

million at December 31, 2019.

The interest rate on the Pinnacle Agreement is based on LIBOR plus an interest rate spread. The pricing under
the Fourth Amendment provides for an interest rate spread of 1.75% to 2.75% above LIBOR with a minimum
LIBOR of 0.90% (representing an interest rate of 3.65% at December 31, 2020). In addition, a fee of 0.25% per
year is charged on the unused line of credit. Interest and the unused line fee are payable quarterly.

Borrowings under the line of credit are collateralized by substantially all of our assets.

F-26

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

Paycheck Protection Program Loan

The PPP is administered by the U.S. Small Business Administration ("SBA"). The loan matures April 14, 2022,
and bears interest at a rate of 1.0% per year, payable monthly. The loan may be prepaid at any time prior to maturity
with no prepayment penalties. Funds from the loan are to be used to maintain payroll, continue group health care
benefits and pay for rent and utilities.

Under the terms of the PPP, certain amounts of the loan may be forgiven if they are used for qualifying
expenses as described in the CARES Act, including qualifying payroll costs, covered rent payments, and covered
utilities. From the date of funding the Company has used the loan amount for such qualifying expenses.
Cumberland has elected to account for the proceeds of the loan as a government grant under International
Accounting Standard 20 ("IAS 20"), Accounting for Government Grants and Disclosure of Government Assistance.
The permitted analogous use of IAS 20 outlines a model for the accounting for government assistance, including
forgivable loans. As a result, the Company has recorded the $2,187,140 as a deferred income liability, which is
included as a component of other current liabilities on the consolidated balance sheet. The Company intends to apply
IAS 20 to the PPP loan forgiveness and has presented the amounts expected to be forgiven as deferred income. The
Company will account for the anticipated forgiveness of the PPP loan under IAS 20 when the Company believes that
the forgiveness is reasonably assured.

Cumberland applied for this loan after carefully considering, with its bank, the eligibility criteria to participate
in this program, and determining that Cumberland met these criteria. The Company evaluated and provided
information on our payroll and other qualifying expenses to determine the amount of PPP funds to apply for.

Cumberland has not laid off or furloughed any employees as a result of the COVID-19 pandemic and, based on
assistance from the PPP loan, the Company currently does not foresee doing so. In October 2020, the Company
submitted a request for forgiveness of the PPP loan. The request was approved by the lender, Pinnacle Bank, who
then submitted it to SBA for the SBA's review and approval.

(10)

Shareholders’ Equity

(a)

Initial Public Offering

On August 10, 2009, the Company completed its initial public offering of 5,000,000 shares of common stock at
a price of $17.00 per share, raising gross proceeds of $85.0 million. After deducting underwriting discounts of
approximately $6.0 million and offering costs incurred of approximately $4.2 million, the net proceeds to the
Company were approximately $74.8 million. Contemporaneously with the offering, each outstanding share of
preferred stock was automatically converted into two million shares of common stock.

(b)

Preferred Stock

The Company is authorized to issue 20,000,000 shares of preferred stock. The Board of Directors is authorized
to divide these shares into classes or series, and to fix and determine the relative rights, preferences, qualifications
and limitations of the shares of any class or series so established. At December 31, 2020 and 2019, there was no
preferred stock outstanding.

(c)

Common Stock

During 2020, 2019 and 2018, the Company issued 228,500 shares, 225,536 shares and 170,759 shares of
common stock, respectively, as a result of restricted shares vesting as well as other common share issuances. There
were no option exercise transactions during 2020, 2019 and 2018.

F-27

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

(d)

Warrants

In connection with the amendment to the debt agreements in 2009, the Company issued warrants to purchase up
to 7,500 shares of common stock at $17.00 per share that expired in July 2019. As of December 31, 2020, there
were no outstanding warrants.

(e)

Share Repurchases

The Company currently has a share repurchase program to repurchase up to $10 million of its common stock
pursuant to Rule 10b-18 of the Securities Act. In January 2019, the Company's Board of Directors established the
current $10 million repurchase program to replace the prior authorizations. The Company repurchased 503,626
shares, 623,478 shares and 443,041 shares of common stock for approximately $1.8 million, $3.5 million, and $2.9
million during the years ended December 31, 2020, 2019 and 2018, respectively. There remains $6.2 million
available under the current repurchase program available for share repurchases at December 31, 2020.

(f)

Cumberland Emerging Technologies

In April 2019, Cumberland Emerging Technologies ("CET"), our majority-owned subsidiary, entered into an
agreement whereby Hongkong WinHealth Pharma Group Ltd. ("WinHealth") made a $1 million investment in CET
through the purchase of shares of its common stock. As part of the agreement, WinHealth obtained the rights to
name an individual for appointment to the CET Board of Directors as well as the first opportunity to license CET
products for the Chinese market. In connection with WinHealth's investment in CET, during 2019, Cumberland also
made an additional $1 million investment in CET. Cumberland purchased additional CET shares through
contribution of $0.3 million in cash and a conversion of $0.7 million in intercompany loans payable. Upon
completion of the additional investment by WinHealth and Cumberland, Gloria Pharmaceuticals returned its shares
in CET in exchange for consideration of $0.8 million that was funded during 2020. After the additional investment,
the Company’s ownership in CET is 85%. As CET is a consolidated subsidiary, the Company reports the operating
results of CET and allocates the noncontrolling interests to the non-majority partners.

(g)

Cumberland Foundation

In December 2017, the Company formed the Cumberland Pharma Foundation (the "Foundation") to serve as a

vehicle to facilitate the ongoing philanthropic endeavors of Cumberland Pharmaceuticals Inc.

The Foundation was formed as a nonprofit corporation designed to qualify as a tax-exempt organization
pursuant to Section 501(a) of the Internal Revenue Code. The Foundation’s Board of Directors is comprised of
Cumberland Pharmaceuticals executives who are responsible for overseeing the Foundation’s ongoing activities
including charitable contributions.

In 2018, Cumberland provided a grant of 50,000 shares of the Company's common stock to the Foundation. The
shares will address the ongoing financial needs of the organization, with most of the shares expected to be held for
the opportunity to realize long term appreciation to support the Foundation’s future. The Foundation maintains
separate financial statements and its ongoing operations will not impact the financial statements of Cumberland
Pharmaceuticals. Initial annual grants by the Foundation have been and are expected to remain consistent with the

F-28

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

historic level of contributions made by Cumberland Pharmaceuticals. During 2019, Cumberland Pharmaceuticals
committed approximately $50,000 in cash contributions that were paid to the Foundation during 2020.

(h)

Nordic Group B.V.

On November 27, 2019, Cumberland received approval from the FDA for the pre-filled syringe of the
Methotrexate product. With this approval, Nordic's 180,000 shares of Cumberland's common stock became vested.
The value of these shares at the date of approval was $0.9 million.

(11)

Earnings (Loss) Per Share

The following table shows the computation of the numerator and the denominator used to calculate diluted

earnings (loss) per share for the years ended December 31:

2020

2019

2018

Numerator:

Net income (loss) from continuing
operations
Discontinued operations

Net income (loss)

Net loss at subsidiary attributable to
noncontrolling interests

Net income (loss) attributable to
common shareholders

Denominator:

Weighted-average shares
outstanding – basic
Dilutive effect of restricted stock and
stock options
Weighted-average shares
outstanding – diluted

(6,625,779) $

(9,211,688) $

(10,820,996)

3,206,875

5,665,177

3,782,224

(3,418,904)

(3,546,511)

(7,038,772)

79,496

8,752

75,704

(3,339,408) $

(3,537,759) $

(6,963,068)

15,162,184

15,396,098

15,614,052

—

15,162,184

15,396,098

15,614,052

The Company's anti-dilutive restricted shares and stock options outstanding were as follows for the years

ended December 31:

Anti-dilutive shares and options

197,610

4,000

41,650

2020

2019

2018

F-29

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

(12)

Income Taxes

The components of the Company's net deferred tax assets at December 31 are as follows:

Deferred Tax Assets

Net operating loss and tax credits

Property and equipment and intangibles

Allowance for accounts receivable

Reserve for expired product

Inventory

Deferred charges

Cumulative compensation costs incurred on deductible equity
awards

Total deferred tax assets

Deferred Tax Liabilities

Intangible assets

Net deferred tax assets, before valuation allowance

Less: deferred tax asset valuation allowance

Net deferred tax assets

2020

2019

16,961,650 $

16,964,685

227,056

249,483

438,235

100,362

952,711

227,072

257,564

469,466

35,227

845,765

928,638

19,858,135

1,047,149

19,846,928

(662,014)

(1,313,965)

19,196,121

18,532,963

(19,196,121)

(18,511,161)

— $

21,802

The following table summarizes the amount and year of expiration of the Company's federal and state net

operating loss carryforwards as of December 31, 2020:

Years of expiration

Federal

State

2021

2022 - 2029

2030

2031 - 2039

Indefinite Period
Total federal and state net operating loss carryforwards

— $

4,342,464

—

45,045,442

44,153,819
7,534,351
4,796,324

458,802
9,829,212
263,861

56,484,494 $

59,939,781

F-30

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

Income tax (expense) benefit includes the following components for the years ended December 31:

Current:

Federal

State and other

2020

2019

2018

21,802 $

65,408 $

(55,902)

79,316

—

(16,636)

Total current income tax (expense)
benefit

(34,100)

144,724

(16,636)

Deferred:

Federal

State

Total deferred income tax
(expense) benefit
Total income tax (expense) benefit $

(21,802)

—

(65,408)

—

(21,802)

(65,408)

—

(55,902) $

79,316 $

(16,636)

The Company’s effective income tax rate for 2020, 2019 and 2018 reconciles with the federal statutory tax rate

as follows:

Federal tax expense at statutory rate

State income tax expense (net of federal
income tax benefit)
Permanent differences associated with
general business credits
Change in valuation allowance

Other permanent differences

Other

Net income tax expense

2020

2019

2018

21 %

4 %

6 %

(23) %

(7) %

(3) %

(2) %

21 %

4 %

7 %

(31) %

1 %

— %

2 %

21 %

4 %

1 %

(25) %

(1) %

— %

The Company believes that it is not more likely than not that its net deferred tax assets will be realized. As
such, the net deferred tax assets, with the exception of one noted below, are fully offset with a valuation allowance
as of the periods ended December 31, 2020, December 31, 2019, and December 31, 2018.

The only deferred tax asset not offset with a valuation allowance as of the periods ended December 31,
2019 and December 31, 2018 was the Company’s AMT Credit Carryforward, which became refundable under the
Tax Cuts and Jobs Act passed in 2017. The Company received the balance of the refund related to this credit during
the period ended December 31, 2020, and as such, the deferred tax asset has been realized and all remaining deferred
tax assets are fully offset with a valuation allowance as of December 31, 2020.

F-31

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

As of December 31, 2020, the Company has general business credit carryforwards of $1.7 million. These

credit carryforwards will expire in years 2021 through 2041.

Years of expiration

2021

2022-2029

2030-2039

2040

Federal

173,475

622,276

836,129

97,244

Total federal and state credit carryforwards

1,729,124

The Company expects it will continue to pay minimal taxes in future periods through the continued utilization of net

operating loss carryforwards, as it is able to achieve taxable income through its operations.

The Company is no longer subject to U.S. federal tax examinations for tax years before 2017, and with few
exceptions, the Company is not subject to examination by state tax authorities for tax years which ended before 2017.
Loss carryforwards and credit carryforwards generated or utilized in years earlier than 2017 remain subject to
examination and adjustment. During 2012, the 2009 federal tax return was examined by the Internal Revenue
Service with no significant findings or adjustments. The Company has no unrecognized tax benefits in 2020, 2019
and 2018.

(13)

Stock-Based Compensation Plans

The Company has grants outstanding under three equity compensation plans, with two of the plans available for
future grants of equity compensation awards to employees, consultants and directors. All of the equity plans were
approved by shareholders. The 2007 Long-Term Incentive Compensation Plan (the "2007 Plan") and the 2007
Directors’ Incentive Plan (the "Directors’ Plan") superseded the 1999 Stock Option Plan. The 2007 Plan and the
Directors’ Plan provide for the issuance of stock options, stock appreciation rights and restricted stock. Vesting is
determined on a grant-by-grant basis in accordance with the terms of the plans and the related grant agreements. The
Company has reserved 2.4 million shares of common stock for issuance under the 2007 Plan and 250,000 shares for
issuance under the Directors’ Plan.

The exercise price of stock options is generally 100% of the fair market value of the underlying common stock
on the grant date. The maximum contractual term of stock options is ten years from the date of grant, except for
incentive stock options granted to 10% shareholders, which is five years.

During 2011, the Company began issuing shares of restricted stock with no exercise price to employees and
directors. Restricted stock issued to employees generally cliff-vests on the fourth anniversary of the date of grant.
Restricted stock issued to directors vests on the one year anniversary of the date of grant.

Stock compensation expense is presented as a component of general and administrative expense in the
consolidated statements of operations. Stock compensation expense consisted of the following for the years ended
December 31:

2020

2019

2018

Share-based compensation - employees

1,050,179 $

1,481,016 $

1,244,606

Share-based compensation -
nonemployees

(3,663)

4,882

120,092

Total share-based compensation

1,046,516 $

1,485,898 $

1,364,698

F-32

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

At December 31, 2020, there was approximately $1.7 million of unrecognized compensation cost related to
share-based payments, which is expected to be recognized over a weighted-average period of 2.28 years. This
amount relates primarily to unrecognized compensation cost for employee restricted stock awards.

Stock Options

Stock option activity for 2020 and 2019 was as follows:

Weighted-
average
exercise price
per share

Weighted-
average
remaining
contractual
term (years)

Aggregate
intrinsic
value

Number of
shares

Outstanding, December 31, 2018

5,800 $

13.00

0.9 $

—

Options granted

Options exercised

—

Options forfeited or expired

(5,800)

13.00

Outstanding, December 31, 2019

Options granted

Options exercised

Options forfeited or expired

Outstanding, December 31, 2020

Exercisable at December 31, 2020

—

— $

—

— $

—

The Company did not grant any stock options and there were no options exercised during 2020, 2019 and 2018.

As such, there was no intrinsic value of options or weighted-average fair value of options exercised for the periods.

Restricted Stock Awards

Restricted stock activity was as follows:

Nonvested, December 31, 2018

Shares granted
Shares vested
Shares forfeited

Nonvested, December 31, 2019

Shares granted
Shares vested
Shares forfeited

Nonvested, December 31, 2020

Number
of shares

Weighted-
average
grant-date
fair value

833,741 $
229,669
(225,536)
(22,925)
814,949
231,091
(228,500)
(38,125)
779,415 $

6.09
5.95
6.71
6.20
5.88
3.56
4.62
5.87
5.56

The fair value of restricted stock granted was based on the closing market price of the Company’s common
stock on the date of grant. The restricted stock grants are included in the diluted weighted shares outstanding
computation until they cliff-vest. Once vested they are included in the basic weighted shares outstanding
computation.

F-33

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

(14)

Employee Benefit Plans

The Company sponsors an employee benefit plan that was established on January 1, 2006, the Cumberland
Pharmaceuticals 401(k) Plan (the "Plan"), under Section 401(k) of the Internal Revenue Code of 1986, as amended,
for the benefit of all employees over the age of 21, having been employed by the Company for at least six months.
The Plan provides that participants may contribute up to the maximum amount of their compensation as set forth by
the Internal Revenue Service each year. Employee contributions are invested in various investment funds based
upon elections made by the employees. During 2020, 2019 and 2018, the Company contributed approximately
$50,000 in each year to the Plan as an employer match of participant contributions.

In 2012 and 2013, the Company established non-qualified unfunded deferred compensation plans that allow
participants to defer receipt of a portion of their compensation. The liability under the plans, reflected in other long
term liabilities in the consolidated balance sheet, was $2.7 million and $2.3 million as of December 31, 2020 and
2019, respectively. The Company had assets consisting of company-owned life insurance contracts generally
designated to pay benefits of the deferred compensation plans reflected in other assets in the consolidated balance
sheet of $2.9 million and $3.1 million as of December 31, 2020 and 2019, respectively.

(15)

Leases

The Company is obligated under long-term real estate leases for corporate office space that was extended during
the third quarter of 2015. Prior to this extension, the lease would have expired in October 2016, the lease is now set
to expire in October 2022. In addition, the research lab space at CET, under an agreement amended in July 2012, is
leased through April 2023, with an option to extend the lease through April 2028. The Company also subleases a
portion of the space under these leases.

Rent expense is recognized over the expected term of the lease, including renewal option periods, if applicable,
on a straight-line basis as a component of general and administrative expense. Rent expense and sublease income as
follows for the years ended December 31:

2020

2019

2018

Rent expense

1,166,411 $

1,246,143 $

1,136,610

Sublease income

680,627 $

688,020 $

662,358

In March 2016, the FASB issued ASU 2016-02. ASU 2016-02’s core principle is to increase transparency and
comparability among organizations by recognizing lease assets and liabilities on the balance sheet and disclosing
key information. The primary effect of adopting ASU 2016-02 to the Company was to record right-of-use assets and
obligations for the leases currently classified as operating leases.

The Company’s significant operating leases include the lease of approximately 25,500 square feet of office
space in Nashville, Tennessee for its corporate headquarters. This lease currently expires in October 2022. The
operating leases also include the lease of approximately 14,200 square feet of wet laboratory and office space in
Nashville, Tennessee by CET, our majority-owned subsidiary, where it operates the CET Life Sciences Center. This
lease currently expires in April 2023.

These operating leases resulted in initial ROU assets of $3.6 million and lease liabilities of $3.8 million as of

January 1, 2019 for non-cancelable operating leases with original lease terms in excess of one year.

F-34

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

Operating lease liabilities were recorded as the present value of remaining lease payments not yet paid for the
lease term discounted using the incremental borrowing rate associated with each lease. Operating lease right-of-use
assets represent operating lease liabilities adjusted for lease incentives and initial direct costs. As the Company’s
leases do not contain implicit borrowing rates, the incremental borrowing rates were calculated based on information
available at January 1, 2019. Incremental borrowing rates reflect the Company’s estimated interest rates for
collateralized borrowings over similar lease terms. The weighted-average remaining lease term is 2.0 years and the
weighted-average incremental borrowing rate used to discount the present value of the remaining lease payments is
7.42%.

Lease Position

At December 31, 2020 and 2019, the Company recorded the following on the Consolidated Balance Sheet:

Operating lease right-of-use assets

Right-of-Use Assets

December 31, 2020

December 31, 2019

2,028,148

2,960,569

Lease Liabilities

December 31, 2020

December 31, 2019

Operating lease current liabilities

Operating lease non-current liabilities

Total

1,016,779

1,059,693

2,076,472

920,431

2,076,472

2,996,903

Cumulative future minimum sublease income under non-cancelable operating subleases totals approximately
$0.4 million and will be paid through the leases ending in October 2022 and April 2023. Future minimum lease
payments under non-cancelable operating leases (with initial or remaining lease terms in excess of one year) are as
follows:

Maturity of Leases Liabilities at December 31, 2020

Operating Leases

2021

2022

2023

After 2023

Total lease payments

Less: Interest

Present value of lease liabilities

1,144,889

1,019,313

92,478
—

2,256,680
(180,208)

2,076,472

(16)

Fair Value of Financial Instruments

The Company owns marketable securities that had a maturity date of less than ninety days and are classified as
cash and cash equivalents at December 31, 2020 and December 31, 2019. There were no transfers of assets between
levels within the fair value hierarchy. The following table summarizes the fair value of these marketable securities
by level within the fair value hierarchy:

F-35

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

December 31, 2020

December 31, 2019

Level 1

Level 2

Total

Level 1

Level 2

Total

Commercial Paper

—

— $ 2,119,607 $ 2,119,607

Total fair value of
marketable securities

— $

— $ 2,119,607 $ 2,119,607

The fair values of all other financial instruments outstanding as of December 31, 2020 and 2019 approximate
their carrying values. There were no changes to the valuation techniques for the Level 2 marketable securities
during 2020 or 2019.

(17) Market Concentrations

The Company is focused on the acquisition, development and commercialization of branded prescription
products. The Company’s principal financial instruments subject to potential concentration of credit risk are
accounts receivable, which are unsecured, and cash equivalents. The Company’s cash equivalents consist primarily
of money market funds. Certain bank deposits may be in excess of the insurance limits provided by the Federal
Deposit Insurance Corporation.

The Company’s primary customers are wholesale pharmaceutical distributors in the U.S. Total revenues by
customer for each customer representing 10% or more of consolidated revenues are summarized below for the years
ended December 31:

Customer 1
Customer 2
Customer 3
*: less than 10% of total

2020

25%
25%
21%

2019

31%
28%
17%

2018

28%
25%
26%

The Company’s accounts receivable, net of allowances, due from the customers representing 10% or more of

consolidated revenue was 60% and 59% at December 31, 2020 and 2019, respectively.

(18) Manufacturing and Supply Agreements

The Company utilizes one or two primary suppliers to manufacture each of its products and product candidates.
Although there are a limited number of manufacturers of pharmaceutical products, the Company believes it could
utilize other suppliers to manufacture its prescription products on comparable terms. A change in suppliers,
problems with its third-party manufacturing operations or related production capacity, or contract disputes with
suppliers could cause a delay in manufacturing or shipment of finished goods and possible loss of sales, which could
adversely affect operating results.

(19)

Employment Agreements

The Company has entered into employment agreements with all its full-time employees. Each employment
agreement provides for a salary for services performed, a potential annual bonus and, if applicable, a grant of
restricted common shares pursuant to a restricted stock agreement.

F-36

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

(20)

Discontinued Operations

In 2016, Cumberland entered into an agreement with Clinigen Group Plc ("Clinigen") for the rights and
responsibilities associated with the commercialization of Ethyol in the United States. In 2017, the Company entered
into another agreement with Clinigen for the rights and responsibilities associated with the commercialization of
Totect in the United States. Ethyol and Totect are collectively referred to herein as the "Products."

Early in 2019, Cumberland announced a strategic review the Company's brands, capabilities, and international
partners. This review followed an accelerated business development initiative, which resulted in a series of
transactions. Because of that progress, Cumberland felt that it was prudent to take a fresh look at our product
portfolio, partners, and organization to ensure proper focus and capabilities. During May 2019, Cumberland entered
into the Dissolution Agreement with Clinigen in which the Company returned the exclusive rights to commercialize
Ethyol and Totect (“the Products”) in the United States to Clinigen. This Dissolution Agreement originally targeted
a transition from the Company's arrangements with Clinigen effective September 30, 2019, but was then amended to
change the transition date to December 31, 2019. Under the terms of the Dissolution Agreement, Cumberland was
no longer responsible for the distribution, marketing and promotion of either the Products or any competing products
after December 31, 2019. In exchange for the return of these product license rights and the non-compete provisions
of the Dissolution Agreement, Cumberland is receiving $5 million in financial consideration paid in quarterly
installments over the two-years following the transition date. Cumberland recorded the first four quarterly
installments totaling $3.0 million during the year ended December 31, 2020.

The exit from the Ethyol and Totect Products meets the accounting criteria to be reported as discontinued
operations. December 31, 2019, as the transition date, was the final day Cumberland was responsible for the
Products. Cumberland was responsible for the Products through December 31, 2019 and beginning on January 1,
2020, the Products' rights transitioned back to Clinigen. As a result, January 1, 2020, was the first day of
discontinued operations for the Ethyol and Totect products.

The Products provided revenue, incurred direct expenses and resulted in discontinued operations income during
the periods presented. The following amounts have been separated from continuing operations, as discontinued
operations, for all periods presented. The direct expenses separated for discontinued operations do not reflect the
direct selling and marketing costs attributable to the individuals at Cumberland responsible for promotion of the
Products. Subsequent to the transaction date, those sales and marketing individuals who supported the Products
shifted their efforts from the Products and continue to support other Cumberland brands.

Revenues

Costs of products sold

Selling, Marketing and other

2020

2019

2018

3,206,875 $

13,145,344 $

11,396,871

—

1,330,704

6,149,463

1,361,273

6,253,374

Income from discontinued operations

3,206,875 $

5,665,177 $

3,782,224

The December 31, 2019 current assets associated with discontinued operations included $0.5 million in the
remaining inventory for the Products sold and returned to Clinigen as part of the transaction. Except for the
Products' inventory as of December 31, 2019, no other operating assets and no liabilities were transferred to
Clinigen, as such the accounts receivable and accounts payable associated with discontinued operations were not
sold or disposed of as part of the Dissolution Agreement. The following assets and liabilities have been presented as
assets associated with discontinued operations or liabilities associated with discontinued operations, as appropriate,
in the consolidated balance sheets.

F-37

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

Accounts receivable

Inventory

Current assets associated with discontinued operations

Accounts payable

Other current liabilities

Current liabilities associated with discontinued operations

(21)

Commitments and Contingencies

Commitments

2020

2019

— $

1,922,457

—

540,267

— $

2,462,724

2020

2019

— $

1,918,868

—

232,489

— $

2,151,357

In connection with the acquisition of certain Kristalose assets during 2011, the Company was required to make
quarterly payments based on a percentage of Kristalose net sales through November 2018. The payments were
treated as consideration for the assets acquired and were capitalized. They are being amortized over the remaining
expected useful life of the acquired asset, currently through 2026.

In connection with its licensing agreements for Caldolor, the Company is required to pay royalties based on net
sales over the life of the product. Royalty expense is recognized as a component of selling and marketing expense in
the period that revenue is recognized.

In connection with its licensing agreements for Ethyol and Totect, the Company was required to pay royalties
based on net sales. The royalty expense was recognized as a component of selling and marketing expense in the
period the associated revenue was recognized through the end of the licensing period, December 31, 2019.

In connection with the acquisition of Vibativ, the Company is required to pay royalties based on net sales of the
product. At the purchase date, Cumberland recorded the fair value of this liability and will continue to evaluate the
liability each period and the royalty expense is recognized as a component of selling and marketing expense in the
period that the change in fair value is recognized.

Legal Matters

Cumberland has a number of Patents issued through the United States Patent and Trademark Office (the
“USPTO”) including U.S. Patent number 8,148,356 (the “356 Acetadote Patent”) which is assigned to the Company.
The claims of the 356 Acetadote Patent encompass the new Acetadote formulation and include composition of
matter claims. Following its issuance, the 356 Acetadote Patent was listed in the FDA Orange Book. The 356
Acetadote Patent is scheduled to expire in May 2026, which time period includes a 270-day patent term adjustment
granted by the USPTO.

Since 2012, Cumberland has continued to vigorously defend and protect its Acetadote product and related

intellectual property rights including the use of all its legal options.

The Company is a party to various other legal proceedings in the ordinary course of its business. In the opinion
of management, the liability associated with these matters, will not have a material adverse effect on the Company's
consolidated financial position, results of operations or cash flows.

F-38

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements (Continued)

(22)

Quarterly Financial Information (Unaudited)

The following table sets forth the unaudited operating results for each fiscal quarter of 2020 and 2019:

2020:

Net revenues

Operating income (loss)

Net income (loss) from continuing
operations
Net income (loss) from discontinued
operations
Net income (loss) attributable to
common shareholders

Earnings (loss) per share attributable to
common shareholders (1)
Continuing operations - basic

Discontinued operations - basic

Basic

Continuing operations - diluted

Discontinued operations - diluted

Diluted

2019:

Net revenues

Operating income (loss)

Net income (loss) from continuing
operations
Net income (loss) from discontinued
operations
Net income (loss) attributable to
common shareholders

Earnings (loss) per share attributable to
common shareholders (1)
Continuing operations - basic

Discontinued operations - basic

Basic

Continuing operations - diluted

Discontinued operations - diluted

Diluted

First
Quarter

Second
Quarter

Third
Quarter

Fourth
Quarter

Total

$ 8,330,734 $ 9,598,177 $ 9,250,689 $ 10,261,534 $ 37,441,134

(1,846,001)

(1,580,962)

(1,208,686)

(1,745,946)

(6,381,595)

(1,883,418)

(1,679,211)

(1,275,620)

(1,787,530)

(6,625,779)

818,273

738,622

777,916

872,064

3,206,875

(1,055,620)

(918,275)

(481,737)

(883,776)

(3,339,408)

(0.12) $

(0.11) $

(0.08) $

(0.12) $

0.05

0.06

(0.07) $

(0.06) $

(0.03) $

(0.06) $

(0.12) $

(0.11) $

(0.08) $

(0.12) $

0.05

0.06

(0.07) $

(0.06) $

(0.03) $

(0.06) $

(0.43)

0.21

(0.22)

(0.43)

0.21

(0.22)

$ 8,729,860 $ 9,417,443 $ 6,935,439 $ 9,305,553 $ 34,388,295

(1,323,932)

(1,373,424)

(3,196,436)

(3,394,390)

(9,288,182)

(1,187,553)

(1,338,521)

(3,316,286)

(3,369,329)

(9,211,688)

1,147,136

771,709

1,349,351

2,396,981

5,665,177

(73,878)

(549,507)

(1,953,668)

(960,706)

(3,537,759)

(0.08) $

(0.09) $

(0.22) $

0.08

0.05

0.09

0.16

— $

(0.04) $

(0.13) $

(0.06) $

(0.08) $

(0.09) $

(0.22) $

0.08

0.05

0.09

0.16

— $

(0.04) $

(0.13) $

(0.06) $

(0.60)

0.37

(0.23)

(0.60)

0.37

(0.23)

(1)

Due to the nature of interim earnings per share calculations, the sum of the quarterly earnings (loss) per share

amounts may not equal the reported earnings (loss) per share for the full year.

F-39

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Valuation and Qualifying Accounts

Years ended December 31, 2020, 2019 and 2018

Schedule II

Description

Balance at
beginning of
period

Charged to
costs and
expenses

Charged to
other
accounts

Deductions

Balance at
end of period

Allowance for uncollectible
amounts, cash discounts,
chargebacks, and credits
issued for damaged products:

For the years ended
December 31:

2018

2019

2020

326,697 $ 4,610,899

804,420

5,915,066

792,051

4,940,313

—

$ (4,133,176) (1) $

804,420

(5,927,435) (1)

(4,747,687) (1)

792,051

984,677

Valuation allowance for
deferred tax assets:

For the years ended
December 31:

2018

2019

2020

$ 15,632,235 $ 1,749,817

17,382,052

1,129,109

18,511,161

684,960

—

$ 17,382,052

18,511,161

19,196,121

(1) Composed of actual returns and credits for chargebacks and cash discounts.

F-40

Officers and Directors

Board of Directors

A.J. Kazimi
Chairman
Cumberland Pharmaceuticals

James R. Jones
Former Managing Partner
KPMG LLP-Nashville

Kenneth J. Krogulski
President and Chief
Investment Officer
Berkshire Asset Management,
LLC.

Caroline R. Young
Executive Director
NashvilleHealth

Former President
Nashville Health Care Council

Joseph C. Galante
Former Chairman
Sony Music Nashville

Former President
RCA Records

Dr. Gordon R. Bernard
Executive Vice President
for Research
Vanderbilt University
Medical Center

Martin E. Cearnal
Executive Vice President and
Chief Commercial Officer
Cumberland Pharmaceuticals

Jonathan I. Griggs
Former Vice President
Human Resources
Warner Lambert Corporation

Joey A. Jacobs
Former Chairman &
Chief Executive Officer
Acadia Healthcare Co. Inc

Former Chairman &
Chief Executive Officer
Psychiatric Solutions, Inc.

Management Team

A.J. Kazimi
Chief Executive Officer

Martin E. Cearnal
Executive Vice President,
Marketing & Sales and
Chief Commercial Officer

Leo Pavliv, R.Ph.
Executive Vice President,
Chief Development &
Operations Officer

James L. Herman
Senior Vice President,
National Accounts and
Chief Compliance Officer

Michael P. Bonner
Executive Director, Finance &
Accounting and
Chief Financial Officer

Todd M. Anthony
Executive Director,
Organizational Development

Tan Cheow Choon
Senior Director, International
Business

Barry L. Lee
Senior Director,
Hospital Products

Cindy B. Patton
Senior Director, Field Marketing

Todd Rice, M.D.
Director, Medical Affairs

Corporate Information

Forward Looking Statement
This annual report includes
forward-looking statements
regarding expected future results
of the company. A variety of
factors could cause actual results
to differ materially from expected
results. Please see the risk
factors more fully described in
our Annual Report on Form 10-K
for the year ended December 31,
2020, which is filed with the
U.S. Securities and Exchange
Commission.

Company Headquarters
Cumberland Pharmaceuticals Inc.
2525 West End Avenue, Suite 950
Nashville, Tennessee 37203
Phone: (615) 255-0068
Toll Free: (877) 484-2700
Fax: (615) 255-0094

Stock Listing
NASDAQ Global Select
Market Ticker Symbol: CPIX

Annual Meeting
9:30 a.m. Central Time
Tuesday, April 27, 2021
Cumberland Headquarters
2525 West End, Suite 950
Nashville, Tennessee 37203

Independent Registered Public
Accounting Firm
BKD, LLP
Two American Center
3102 West End Avenue
Suite 1050
Nashville, TN 37203
(615) 988-3600

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