Working together to provide
unique products that improve patient care
2023 Annual Report
2023 Highlights
Delivering Our Products to New Patients
May | Caldolor® Newborn Indication & Study Publication
The FDA approved expanded labeling for our Caldolor product, an intravenously delivered
formulation of ibuprofen, to include use in infants. The non-narcotic agent may now be
administered for the treatment of pain and fever in patients 3 to 6 months of age. With this newly
approved labeling, Caldolor is the only non-opioid product approved to treat pain in infants that is
delivered through injection.
We also shared the positive results from a clinical study investigating the safety and
pharmacokinetics of Caldolor in newborns, published in the journal Pediatric Drugs. The results of
the study support the growing body of evidence that demonstrates Caldolor is a safe therapeutic
option available to practitioners for the treatment of fever and pain in infants, children and adults.
June | Expanded Oncology Sales Division
We expanded our oncology sales division as we work to deliver our newest brand Sancuso® –
to help cancer patients tolerate their chemotherapy treatments. Sancuso is the first and only
FDA-approved prescription patch for the prevention of nausea and vomiting in patients receiving
certain types of chemotherapy.
October | New Vibativ® Pediatric Study Publication
We announced a new publication in Antimicrobial Agents and Chemotherapy detailing the
results of the first clinical study investigating the safety and pharmacokinetics of our Vibativ
product in children 2 to 17 years of age. Vibativ is an intravenous antibiotic approved by the FDA
for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia, as well
as complicated skin and skin structure infections caused by certain gram-positive bacteria. The
results of the study suggest that a single dose of Vibativ is safe in children and they experience
reduced exposure to Vibativ, compared with the same body weight-based dosing in adults.
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2023 Annual Report
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To Our Shareholders,
Employees & Partners:
In many ways 2023 was a building year for Cumberland,
as we continued to integrate our newest products, while
also delivering several significant achievements.
During the year we took a fresh look at our mission
statement and refined it to better capture the spirit of
what we do each day at Cumberland. Our mission is
now: working together to provide unique products that
improve the quality of patient care.
Additionally, we shared the results of the first pediatric
study investigating the safety and pharmacokinetics of
our Vibativ product. The results suggest that a single
dose of Vibativ can be safely administered to children to
fight certain serious skin and lung infections.
Meanwhile, we completed the expansion of our oncology
sales division as we work to deliver our newest brand,
Sancuso, to cancer patients.
In designing this statement, we considered several factors.
First, we wanted our mission to address the
constituencies we serve, which include patients in need
of care, as well as health care providers, our employees,
shareholders, partners and community.
We also sought to reflect Cumberland’s culture, where
teamwork is prized, emphasized and expected – in order
to achieve our goals.
Next, it needed to demonstrate our focus on developing,
acquiring and distributing differentiated brands.
And finally, we wanted to emphasize that the patient is
at the core of everything we do. Our collective efforts
are directed at providing unique products that serve as
better alternatives for poorly met medical needs.
Now, as we report on the progress we made throughout
2023, we are pleased to share a few exciting updates
including the growth opportunities for our portfolio of
branded medicines.
Following the FDA’s approval to expand the labeling
for Caldolor, our non-narcotic agent may now be
administered for the treatment of pain and fever in
patients 3 to 6 months of age. This expanded use
was further supported by the publication of positive
results from a clinical study investigating the safety
and pharmacokinetics of Caldolor in newborns. We are
thrilled to extend Caldolor’s labeling for these youngest
of patients.
As we remain focused on delivering our products to
patients within the U.S., we continue to work with our
partners in their efforts to register and launch Vibativ
in several international markets, which should provide
significant future catalysts for the brand.
We also continue to progress our pipeline of innovative
products designed to improve patient care and patients’
quality of life. Our ifetroban product candidate is being
evaluated in a number of Phase II clinical trials for
patients with a series of unmet medical needs.
It has now been dosed in nearly 1,400 subjects and
has been found to be safe and well tolerated in those
individuals. We look forward to sharing the results from
these studies as they emerge and then deciding on the
best development path for the product, which we believe
has the potential to benefit many patients.
We remain committed to fulfilling our newly
refined mission by building a portfolio of specialty
pharmaceutical brands, which we do by maximizing the
potential of our commercial brands, progressing our
pipeline and also pursuing select acquisitions.
All the best,
A.J. Kazimi
Chairman and Chief Executive Officer
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Products to
enhance patients’ lives
For more information on Cumberland’s approved products,
including safety and full prescribing information, please visit
links to the individual product websites, which can be found
on our corporate website, www.cumberlandpharma.com.
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Products to
enhance patients’ lives
Addressing unmet medical needs
through our product portfolio
With a focus on underserved, specialty markets, including hospital acute
care, gastroenterology and oncology, we develop and acquire medicines
that are designed to offer distinct advantages over prior treatments.
Our portfolio of FDA-approved brands is supported through our
hospital, field, and oncology sales divisions along with our national
accounts and field-based medical teams across the United States.
Our commercial product line includes the brands shown below.
(acetylcysteine) An injection used
for the treatment of acetaminophen
poisoning, which is the leading cause of
drug toxicity in the U.S.
(lactulose) The only branded prescription
laxative product that combines the
established safety and efficacy of lactulose
with the convenience and portability of a
pre-measured dose
(granisetron) The first and only FDA-
approved prescription patch that prevents
nausea and vomiting in patients receiving
certain types of chemotherapy treatment
(ibuprofen) The first injectable therapy
approved in the U.S. for the treatment of
both pain and fever
(conivaptan) The first and only
intravenously administered vasopressin
receptor antagonist, which is used
to raise serum sodium levels in
hospitalized patients with euvolemic
and hypervolemic hyponatremia
(telavancin) An injection used 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
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Building a Pipeline of
Differentiated Products
In addition to our portfolio of FDA-approved brands, we continue to advance our pipeline of new
product candidates. All part of our ifetroban program, our development candidates have the potential
to help multiple patient populations and are designed to treat conditions for which there is currently no
FDA-approved pharmaceutical treatment.
Our Pipeline Includes:
Preclinical
IND
Phase I
Phase II
Phase III
NDA
Dyscorban®
An oral capsule to treat cardiomyopathy associated with duchenne
muscular dystrophy (DMD), a fatal, genetic neuromuscular disease
The FDA has cleared the Investigational New Drug (IND) application
for this program and a Phase II clinical trial in DMD patients has been
initiated, with enrollment advancing.
The FDA has also provided grant awards of over $1 million to
support this study.
Vasculan®
An oral capsule to treat systemic sclerosis (SSc), also known
as scleroderma, a rare, debilitating autoimmune disorder that
results in a thickening of the skin and internal organs
With FDA clearance of our IND, this Phase II study in SSc patients
is well underway.
We are also developing an oral capsule to treat
idiopathic pulmonary fibrosis (IPF), the most common
form of progressive fibrosing interstitial lung disease
Following FDA clearance of our IND, we are in the
process of initiating our Phase II study in IPF patients
in centers of excellence across the U.S.
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Cumberland
Emerging Technologies
A collaboration to advance biomedical innovation
The U.S. leads the world in biomedical innovation,
including the development of new medicines.
To create a long-term product pipeline and also
help build the local biomedical industry, we
formed Cumberland Emerging Technologies
(CET). As a majority owned subsidiary of
Cumberland Pharma, CET helps inventor
scientists and life science companies develop
health care solutions and provides needed
support to advance these solutions toward the
commercial marketplace.
CET partners with several major academic
research institutions, led by joint activities with
Vanderbilt University and the Vanderbilt Medical
Center. Together we work to identify early-stage
biomedical research opportunities and develop
the resulting new biopharmaceutical product
candidates to improve patient care.
CET has also established and manages the
Nashville Life Sciences Center, which serves as
an incubator for Middle Tennessee’s emerging
biomedical industry.
CET represents a joint initiative between
Cumberland Pharmaceuticals, Vanderbilt
University, Launch Tennessee – a state-
supported network created to empower
Tennessee’s entrepreneurial ecosystem –
and WinHealth Pharmaceuticals – our
international partner.
At CET we team with academic research groups
and support the development process for
selected projects, providing critical expertise on
intellectual property, regulatory, manufacturing
and marketing issues essential to the successful
development of new biomedical products.
The Life Sciences Center provides offices,
laboratory space, and equipment to early-stage
companies looking to develop their technologies
and products. We maintain the Cumberland
Pharmaceuticals formulation and testing
laboratory at the CET Life Sciences Center.
Nearly 30 life science companies exist today
because of CET, including a vibrant group of
current tenants at the Life Sciences Center as well
as a growing number of successful graduates.
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Providing Medicines to
Patients Around the World
A look at our key international partnerships
Bringing our medicines to patients throughout
the world through a growing network of
distinguished international partners
Tennessee
Cardinal Health Inc. provides
warehousing, shipping and
other distribution support for
our products in the U.S.
Mexico
PiSA Pharmaceutical is our
commercial partner for Caldolor.
Saudi Arabia and Jordan
Tabuk Pharmaceutical
Manufacturing Company is our
commercial partner for Vibativ.
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To provide for the availability of our products, we have established a network of
distribution partners. Our international partners are responsible for registering
and commercializing select Cumberland products, allowing us to provide our
unique medicines to better the quality of patient lives in their countries.
Russia and CIS
R-Pharm JSC is our commercial
partner for Vibativ.
South Korea
D.B. Pharm Korea Co. Ltd. is
our commercial partner for
Caldolor and Vibativ.
China
WinHealth Pharma Group is our
commercial partner for Caldolor
and Acetadote, and an investor in
Cumberland Emerging Technologies.
SciClone Pharmaceuticals is our
commercial partner for Vibativ.
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Australia
Phebra Pty Ltd. is our
commercial partner for
Acetadote and Caldolor.
India
Sandor Medicaids Pvt.
Ltd. is our commercial
partner for Caldolor.
The once-daily antibiotic infusion with a dual
mechanism of action indicated for MRSA and MSSA
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Sustainability 2023 At a Glance
ENVIRONMENT
Supplies
Contracted with third-party
companies for the
manufacturing, packaging
and warehousing of
our products
Waste
Ensured strict
guidelines and
processes for the safe,
permanent disposal of
all unused product
Returns
Received and
disposed of
5,891
pounds of
damaged and
expired products
SOCIAL
Community
Involvement
Cumberland Pharma Foundation
Contributed to Denver Health,
Loyola University, Tennessee State
Museum, American Heart Association,
Tennessee Historical Society,
Belmont University &
University of Mississippi
Sponsorships
Nashville Health Care Council’s Wall
Street’s View of Healthcare Event
Associations
• Nashville Health Care Council
• Life Science Tennessee
• Nashville Chamber of Commerce
Life Sciences Center
Provide a lab and incubator to help build
the biomedical industry in our area
GOVERNANCE
Board
Independent – 7 of 8
Tenure – Average 9.8 years
Age – Average 66 years
Male/ Female – 6/1
Turnover – None
Board
Meeting
Attendance
100%
Standing
Committee
Attendance
100%
SOCIAL
Employees
Male – 56%
Female – 44%
Minorities – 15%
Ages
6.5% below 30
27.5% between 30 & 50
66% over 50
Turnover – 19.1%
Additions – 20%
Career Development Program
Available to all corporate employees
Cumberland Academy
Provides industry training for
corporate employees
Tenures
35% @ 5 or more years
25% @ 10 or more years
10% @ 15 or more years
Training
Average $4,000
per full-time
employee
Work-related
injuries
None
SOCIAL
Patients
Provided
3
million doses
of our products to patients
Clinical Trials Safety
No trials terminated due to failure
to practice good clinical standards
Advocacy Groups Supported
• Muscular Dystrophy Association
• Parent Project Muscular Dystrophy
Drug Safety Results
• No products listed in
the FDA’ s MedWatch
Safety Alerts
• No products recalled
Patient AffordAbility
We cover up to 71% of
patient Rx costs through
coupons for our GI brand
GOVERNANCE
Compliance
GOVERNANCE
Government Relations
Code of Conduct
Establishes guidelines for all
Board members and employees
Cumberland Health
& Wellness PAC
Supports candidates,
elected officials and
relevant legislation
Ethical Marketing
No government
judgments, decrees
or fines
Health Care
Professionals
All reports regarding
relations filed on time
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Selected Financial Data
Our strategy involves maximizing the potential of our existing brands while continuing to build a
portfolio of unique, differentiated products. The result of these efforts has strengthened our market
presence, diversified our revenue stream and delivered positive cash flow from operations in 2023.
(dollars in thousands except per share data)
Net Revenues
Less Total Expenses
Net Income (Loss)
Cash Flow from Operating Activities
Total Assets
Total Liabilities
Total Equity
2019
$47,553
51,091
(3,538)
3,056
104,549
53,464
51,085
2020
$37,441
40,780
(3,339)
5,415
96,463
49,590
46,873
2021
$35,985
39,493
(3,508)
6,342
84,460
41,858
42,602
2022
$42,011
47,661
(5,650)
8,453
92,925
56,951
35,974
2023
$39,553
45,884
(6,331)
6,094
81,776
52,516
29,260
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)
2019
2020
2021
2022
2023
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
($3,538)
($6,625)
($5,597)
($5,650)
($6,331)
(79)
4,404
1,486
–
(243)
56
4,749
1,047
440
(75)
35
4,606
742
(1,051)
(26)
246
263
98
69
5,328
447
1,368
(98)
586
46
8,280
365
(347)
(287)
668
($2,276)
($146)
($1,193)
$2,050
$2,394
Adjusted Diluted Earnings per Share
($0.32)
($0.01)
($0.08)
$0.14
$0.17
Diluted Weighted-Average Common
Shares Outstanding:
15,764
15,162
14,905
14,809
14,526
(1) The supplemental financial measures are Non-GAAP as defined, the reconciliation of these supplemental measures is above.
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2023 Annual Report
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Board of Directors
A.J. Kazimi
Chairman
Chief Executive Officer
Cumberland Pharmaceuticals
James R. Jones
Director
Former Managing Partner
KPMG LLP-Nashville
Dr. Gordon R. Bernard
Director
Professor of Medicine
Division of Pulmonary & Critical Care Medicine
Vanderbilt University Medical Center
Kenneth J. Krogulski
Lead Director
Managing Partner and
Chief Investment Officer
Berkshire Asset Management
Caroline R. Young
Director
Vice President of Partnership Development
Frist Cressey Ventures
Former President
Nashville Health Care Council
Martin S. Brown
Director
Attorney of Counsel
Adams and Reese LLP
Former Board Director
Brown-Forman Corporation
Joseph C. Galante
Director
Former Chairman
Sony Music Nashville
Former President
RCA Records
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Corporate Information
Forward-Looking
Statements
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, 2023, which is filed
with the U.S. Securities and Exchange
Commission.
Company Headquarters
Cumberland Pharmaceuticals Inc.
1600 West End Avenue, Suite 1300
Nashville, TN 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
Wednesday, April 24, 2024
Cumberland Headquarters
1600 West End Avenue, Suite 1300
Nashville, TN 37203
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(615) 665-1811
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