2024 Annual Report
Unique Medicines, Quality Care, Better Lives
2024 HIGHLIGHTS
New Study Compared Caldolor® to Ketorolac
A study published in Frontiers of Pain Research provided compelling evidence that our Caldolor
product, an intravenously delivered formulation of ibuprofen, is associated with a significantly
reduced incidence of adverse drug reactions when compared to its key competitor, ketorolac.
Notably, patients experienced fewer gastrointestinal complications as well as reduced headaches,
nausea and abdominal pain. Additionally, Caldolor demonstrated a positive impact on health care
resource utilization when compared to ketorolac, with decreased emergency room and outpatient
visits, as well as a shortened hospital length of stay for both adults and children..
FDA Granted Orphan Drug Designations for lfetroban
Our ifetroban product candidate received FDA Orphan Drug and Rare Pediatric Disease
designations for the treatment of cardiomyopathy in Duchenne muscular dystrophy (DMD), a
devastating genetic disorder affecting young boys. These designations recognize the urgent need
for effective treatments and also provide vital support to accelerate research and development.
They represent hope for families and a pathway to bring transformative medicines to a vulnerable
patient population more quickly and efficiently.
FDA Approved New, Simplified Dosing Regimen for Acetadote®
The FDA approved a supplemental New Drug Application for our Acetadote product, an
intravenous formulation of N-acetylcysteine indicated to prevent or lessen liver injury after
ingestion of potentially toxic quantities of acetaminophen. A common over-the-counter pain
reliever and fever reducer, acetaminophen is the leading cause of acute liver failure in the
United States.
The new, streamlined approach is designed to reduce the frequency of medication errors and
potentially serious non-allergic anaphylactoid reactions, without compromising the effectiveness
of Acetadote. By simplifying the dosing regimen, health care providers can administer the life-
saving treatment more efficiently, potentially improving patient outcomes.
Advancing Our
Portfolio and Pipeline
December
November
November
Cumberland’s business strategy has been to establish
two key core competencies – the development of new
medicines and our own capabilities to commercialize
them. We have also been building a network of
international partners to bring our medicines to patients
in their countries.
I am pleased to share a number of key developments
during 2024 that enabled us to advance in our newly
refined mission – working together to provide unique
products that improve the quality of patient care.
We announced the publication of new real-world
outcomes research in 150,000 patients comparing our
Caldolor® product to its key competitor, ketorolac. The
results provided compelling evidence that Caldolor
offers a better safety profile, as a result of its significantly
reduced incidence of adverse drug reactions. Caldolor also
provides a potential significant cost savings to the health
care facility, based on the findings that it improves their
resource utilization.
Additionally, a Caldolor Special Report was published
that presented the growing amount of data supporting
the product’s use as a standard of care for the treatment
of pain and fever. The report presented the studies
demonstrating that Caldolor is a safe and effective
treatment for pain and fever in adults, children and infants.
Meanwhile, we announced the FDA approval of expanded
labeling for Acetadote®, our treatment for the liver injury
associated with acetaminophen toxicity. The newly
approved dosing regimen simplifies the administration
of Acetadote by combining the first two bags of the
standard regimen into a single, slower infusion. The new
approach allows health care providers to administer the
life-saving treatment more efficiently in order to improve
patient outcomes.
We also made significant progress in advancing the
Phase II clinical trials evaluating our ifetroban product
candidate. We closed our study in patients with Duchenne
muscular dystrophy (DMD), approached the conclusion of
enrollment in our systemic sclerosis study and significantly
progressed our study in patients suffering from pulmonary
fibrosis. These programs are designed to address unmet
medical needs in large potential markets.
We were delighted to receive both Orphan Drug
Designation and Rare Pediatric Disease Designation
from the FDA for the use of ifetroban for the treatment of
DMD heart disease, reflecting its potential significance in
treating this devastating condition.
At Cumberland Emerging Technologies (CET) we
announced favorable top-line results from an investigator-
led Phase II study evaluating our new treatment for
delirium in critically ill patients. CET also entered into
a development agreement with a corporate partner
to fund a new product designed to locate sites of
internal bleeding. We are building a long-term pipeline
of innovative biopharmaceutical products at CET in
collaboration with academic research groups.
Turning to our commercial operations, we continued to
be encouraged to see the positive impact on our business
as more states provided favorable Medicaid coverage for
Kristalose®, our prescription-strength laxative.
Manufacturing for our oncology support medication
Sancuso® was transferred to a new facility that received
FDA approval. We then introduced our newly Cumberland-
packaged product, supported by an expanded oncology
sales division.
On the international front, we began shipping Vibativ®,
our potent antibiotic, to Saudi Arabia. Our partner for the
product in China progressed approval in their country –
the world’s second largest pharmaceutical market.
Looking ahead, we remain focused on our mission and will
continue to build our specialty pharmaceutical business
by maximizing the potential of our commercial brands,
progressing our pipeline and pursuing select acquisitions.
We are entering an exciting time for our Company!
I’d like to extend a special thanks to the entire Cumberland
team for their dedicated efforts and many contributions
that enable us to build value and help many patients.
All the best,
A.J. Kazimi
Chairman and Chief Executive Officer
To Our Shareholders,
Employees & Partners:
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2024 Annual Report
Advancing specialty care with innovative medicines
We are dedicated to our mission of working together to provide unique products that improve the quality
of patient care. We develop, acquire and commercialize brands for select medical specialties, including
hospital acute care, gastroenterology and oncology. Cumberland’s products are tailored for underserved,
specialty markets and are designed to offer distinct advantages over prior treatments.
Our innovative product portfolio of FDA-approved brands is supported by our dedicated hospital, field and
oncology sales divisions, as well as our national accounts and field-based medical teams across the country.
Our commercial product line includes the brands shown to the right.
Differentiated Brands,
Unique Profiles,
Patient-Focused
(acetylcysteine)
An injection used
for the treatment of
acetaminophen poisoning,
which is the leading cause
of drug toxicity in the U.S.
(conivaptan)
The only intravenously
administered vasopressin
receptor antagonist, which
is used to raise serum
sodium levels in hospitalized
patients with euvolemic and
hypervolemic hyponatremia
(salt imbalances)
(ibuprofen)
An injectable therapy
that reduces pain, fever
and inflammation for
patients, including those
undergoing surgeries
(granisetron)
An innovative
prescription patch
designed to prevent
nausea and vomiting
in patients receiving
certain types of
chemotherapy
treatment
(lactulose)
The only branded
prescription laxative
product that combines
the established
safety and efficacy
of lactulose with
the convenience
and portability of
a crystalline, pre-
measured dose
(telavancin)
A potent antibiotic delivered
through 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
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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2024 Annual Report
We are developing an innovative new chemical entity – ifetroban – with the potential to help patients
with conditions for which there are no satisfactory approved treatments.
Developing a Pipeline to
Address Unmet Medical Needs
Preclinical
IND
Phase I
Phase II
Phase III
NDA
Our development programs include:
Dyscorban®
An oral capsule to treat cardiomyopathy associated with Duchenne
muscular dystrophy, a fatal, genetic neuromuscular disease
Following a Phase II study, completion of data analysis and a full
study report are underway in preparation for a meeting with the
FDA to determine next steps for the product’s development and
commercialization.
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 nearing completion.
Ifetroban
We are 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, a Phase II
clinical study is underway in IPF patients in centers of
excellence across the U.S.
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Cumberland Pharmaceuticals
The U.S. is a global leader in biomedical
innovation, driving the discovery of new
medicines. To foster our long-term product
development and strengthen the local
biomedical industry, we established Cumberland
Emerging Technologies (CET). A majority-owned
subsidiary of Cumberland Pharmaceuticals, CET
supports inventor-scientists and life science
companies in advancing health care solutions
toward commercialization.
CET is a collaborative initiative between
Cumberland Pharmaceuticals, Vanderbilt
University, Launch Tennessee (a state-backed
network supporting entrepreneurship) and
WinHealth Pharmaceuticals, our international
partner. We work closely with academic research
groups, providing expertise in intellectual
property, regulatory pathways, manufacturing
and marketing to accelerate the development
of promising biomedical products. We
also partner with major academic research
institutions to identify and develop early-stage
biopharmaceutical innovations that enhance
patient care.
Additionally, CET has established and manages
the Nashville Life Sciences Center (LSC), which
houses Cumberland’s formulation laboratories
and also serves as an incubator for Middle
Tennessee’s emerging biopharmaceutical
industry.
The LSC features flexible wet lab, dry lab and
office space with opportunities for custom build
outs. Additionally, it offers shared lab space and
essential laboratory equipment to help tenants
limit overhead costs and maximize resources. It
was founded in response to a shortage of wet lab
space in Middle Tennessee, which has historically
inhibited the startup and progress of new
biomedical companies and commercialization of
new life science technologies.
With a vibrant group of current tenants and a
growing number of successful graduates, the
Life Sciences Center is a main driver behind
building a strong commercial life sciences
ecosystem in Middle Tennessee.
Cumberland Emerging Technologies
Fostering collaboration, developing biomedical products,
advancing innovation
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2024 Annual Report
Tennessee
Cardinal Health Inc. provides
warehousing, shipping and
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.
An overview of our key international partnerships
To ensure the availability of our products, we have built a network of established international partners.
These companies are responsible for registering and commercializing select Cumberland products,
and we support them in their efforts to bring our unique medicines to patients in their countries.
Bringing Our Medicines
to Patients Worldwide
6
Cumberland Pharmaceuticals
Australia
Phebra Pty Ltd. is our
commercial partner for
Acetadote and Caldolor.
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.
South Korea
D.B. Pharm Korea Co. Ltd. is
our commercial partner for
Caldolor and Vibativ.
Russia and CIS
R-Pharm JSC is our commercial
partner for Vibativ.
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2024 Annual Report
1 patch. 5-day
nausea relief.
An innovative FDA-approved
patch designed to help prevent
chemotherapy-associated nausea.
Returns
Received and disposed of 12,480 pounds of damaged
and expired products
Provided
of our products to patients
3.9
Supplies
Contracted with third-
party companies for the
manufacturing, packaging
and warehousing of our
products
Male – 51%
Female – 49%
Career Development Program
Available to all corporate employees
Cumberland Academy
Provides industry training for
corporate employees
Training
Average $600
per full-time
employee
Work-related
injuries
None
Minorities – 27%
Turnover – 9.8% for corporate team
22.5% for sales team
Additions – 23%
Patient Affordability
We cover up to 80% of
patient Rx costs through
coupons for our GI and
oncology support brands
Ages
7% below 30
27% between 30 & 50
66% over 50
Tenures
38% @ 5 or more years
24% @ 10 or more years
12% @ 15 or more years
Drug Safety Results
• No products listed in
the FDA’ s MedWatch
Safety Alerts
• No products recalled
Cumberland Health
& Wellness PAC
Supports candidates,
elected officials and
relevant legislation
Clinical Trials Safety
No trials terminated due to failure
to practice good clinical standards
Advocacy Groups Supported
• Muscular Dystrophy Association
• Parent Project Muscular Dystrophy
Waste
Ensured strict
guidelines and
processes for the safe,
permanent disposal of
all unused product
ENVIRONMENT
SOCIAL
Employees
SOCIAL
Patients
Cumberland Pharma Foundation
Contributed to the American Red Cross for
Disaster Relief following Hurricane Helene,
Denver Health, Vanderbilt University Medical
Center, Gettysburg Foundation, Belmont
University’s Healthcare Hall of Fame, Mary Parish
Center, World Bible School, AACA Museum
Endowment Fund & University of Mississippi
Sponsorships
• Nashville Health Care Council’s Wall
Street’s View of Healthcare Event
• Alliance for an Affordable (Housing)
Nashville Summit
Associations
• Nashville Health Care Council
• Life Science Tennessee
• Nashville Chamber of Commerce
Life Sciences Center
An incubator to help build the biomedical
industry in our area
SOCIAL
Community Involvement
Code of Conduct
Establishes guidelines for all
Board members and employees
Ethical Marketing
No government
judgments, decrees
or fines
Health Care
Professionals
All reports regarding
relations filed on time
Independent – 6 of 7
Tenure – Average 10.8 years
Age – Average 67 years
Male/ Female – 6/1
Turnover – None
Board
Meeting
Attendance
Standing
Committee
Attendance
GOVERNANCE
Board
GOVERNANCE
Government Relations
GOVERNANCE
Compliance
100%
100%
Sustainability 2024 At a Glance
million doses
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2024 Annual Report
Your Non-Opioid Pain Management Solution
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.
Now Approved for
Treating Pain and Fever in
Adults, Children & Newborns
Intravenous Ibuprofen
Board of Directors
Kenneth J. Krogulski
Lead Director
Managing Partner and
Chief Investment Officer
Berkshire Asset Management
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
Joseph C. Galante
Director
Former Chairman
Sony Music Nashville
Former President
RCA Records
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
A.J. Kazimi
Chairman
Chief Executive Officer
Cumberland Pharmaceuticals
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2024 Annual Report
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 and diversified our revenue stream in 2024.
Reconciliation of Net Income (Loss) Attributable to Common Shareholders to Adjusted
Earnings and Adjusted Diluted Earnings Per Share (1) (Unaudited)
(1) The supplemental financial measures are Non-GAAP as defined, the reconciliation of these supplemental measures is above.
(dollars in thousands except per share data)
2020
2021
2022
2023
2024
Net Revenues
Less Total Expenses
$37,441
40,780
$35,985
39,493
$42,011
47,661
$39,553
45,884
$37,868
44,312
Net Income (Loss)
(3,339)
(3,508)
(5,650)
(6,331)
(6,444)
Cash Flow from Operating Activities
5,415
6,342
8,453
6,094
(612)
Total Assets
96,463
84,460
92,925
81,776
75,583
Total Liabilities
49,590
41,858
56,951
52,516
53,037
Total Equity
46,873
42,602
35,974
29,260
22,546
(dollars in thousands except per share data)
2020
2021
2022
2023
2024
Net Income (Loss) from Continuing
Operations
($6,625)
($5,597)
($5,650)
($6,331)
($6,444)
Adjustments to Net Income (Loss)
Income Tax Expense (Benefit)
56
35
69
46
(23)
Depreciation and Amortization
4,749
4,606
5,328
8,280
4,902
Share-Based Compensation
1,047
742
447
365
302
Other Adjustments to Net Income (1)
440
(1,051)
1,368
-
-
Interest Income
(75)
(26)
(98)
(287)
(334)
Interest Expense
263
98
586
668
606
Adjusted Earnings
($146)
($1,193)
$2,050
$2,741
($991)
Adjusted Diluted Earnings per Share
($0.01)
($0.08)
$0.14
$0.20
($0.07)
Diluted Weighted-Average Common
Shares Outstanding:
15,162
14,905
14,809
14,526
14,060
Selected Financial Data
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Cumberland Pharmaceuticals
Stock Listing
Nasdaq Global Select
Market Ticker Symbol: CPIX
Annual Meeting
9:30 a.m. Central Time
Tuesday, April 22, 2025
Cumberland Headquarters
1600 West End Avenue, Suite 1300
Nashville, TN 37203
Independent Registered
Public Accounting Firm
Carr, Riggs & Ingram, LLC
3011 Armory Drive, Suite 300
Nashville, TN 37204
(615) 665-1811
Transfer Agent and
Registrar
Continental Stock Transfer
& Trust Company
1 State Street, 30th Floor
New York, NY 10004
(800) 509-5586
(212) 509-4000
cstmail@continentalstock.com
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, 2024, 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
Corporate Information
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2024 Annual Report