UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): December 8, 2017 (December 5, 2017) | |
Cumberland Pharmaceuticals Inc.
__________________________________________
(Exact name of registrant as specified in its charter)
Tennessee | 001-33637 | 62-1765329 | |
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | |
2525 West End Avenue, Suite 950, Nashville, Tennessee | 37203 | ||
(Address of principal executive offices) | (Zip Code) | ||
Registrant's telephone number, including area code: (615) 255-0068 | |||
Not Applicable
____________________________________________
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 7.01. Regulation FD Disclosure
Cumberland Pharmaceuticals Inc. (the "Company"), is a specialty pharmaceutical company focused on hospital acute care, gastroenterology, and oncology supportive care. Company representatives began meeting with investors utilizing the presentation which is furnished as Exhibit 99.1 and is also on the Company's website.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
Exhibit No. | Description | |
Investor Presentation | ||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Cumberland Pharmaceuticals Inc. | ||
December 8, 2017 | By: Michael Bonner | |
Name: Michael Bonner | ||
Title: Chief Financial Officer | ||
Exhibit Index
Exhibit No. | Description | |
Investor Presentation | ||
Investor Presentation
Safe Harbor
Statement
This presentation contains forward-looking statements
concerning our approved products and product
development, our technology, our competitors, our
intellectual property, our financial condition and our plans
for research and development programs that involve risks,
uncertainties and assumptions. These statements are
based on the current estimates and assumptions of the
management of Cumberland Pharmaceuticals as of the
date of this presentation and are subject to uncertainty and
changes in circumstances. Given these uncertainties, you
should not place undue reliance upon these forward-
looking statements. Such forward-looking statements are
subject to risks, uncertainties, assumptions and other
factors that may cause the actual results of Cumberland
Pharmaceuticals to be materially different from those
reflected in such forward-looking statements.
Important factors that could cause actual results to differ
materially from those indicated by such forward-looking
statements include, among others, those set forth under
the headings "Risk factors" and "Management's discussion
and analysis of financial condition and results of
operations" in our Form 10-K and Form 10-Q Reports on
file with the SEC. The Company does not undertake any
obligation to release publicly any revisions to these
forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the
occurrence of unanticipated events. All statements
contained in this presentation are made only as of the date
of this presentation
2
Company
Overview
• Specialty pharmaceutical company
• Portfolio of seven FDA approved products
• Promoted by two national sales forces
• Several near-term catalysts for new growth opportunities
• Four Phase II products in development with upcoming study milestones
• Proven record of successful product development and product acquisition
• Strong financial position and positive net cash flows from operations
3
Marketed
Brands
HOSPITAL
Acetadote®
(Acetaminophen Toxicity)
Caldolor®
(Pain and Fever)
Vaprisol®
(Hyponatremia)
Ethyol®
(Amifostine)
Totect®
(Dexrazoxane)
GASTROENTEROLOGY
Kristalose®
(Acute/Chronic Constipation)
Omeclamox®-Pak
(H. pylori)
4
• IV treatment for acetaminophen overdose
• Developed and registered by Cumberland
• Acetaminophen is the leading cause of poisoning in the U.S.*
• Acetadote now standard of care
• Cumberland offers both Brand and Authorized Generic
• Favorable court rulings upholding patents
• Maintaining significant market share
*National Poison Data System, American Association of Poison Centers
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• Patented, injectable formulation of ibuprofen
• Developed and registered by Cumberland
• First injectable approved in the US for pain & fever
• Unresolved pain remains leading cause for hospital
readmissions, with a total market potential of over 700M units*
• Significant data supports pre-op management of inflammation
• Pediatric labeling approved by FDA and launched
*Symphony Source Health
6
• Re-launch of an FDA-approved oncology hospital brand
• Protects against the harmful effects of cancer treatments
• Protects the patient’s healthy tissue, not the tumor
• Indicated for use with head & neck and ovarian cancers
• Potential to become Cumberland’s largest selling brand
8
• FDA-approved oncology hospital brand
• Indicated to treat toxic effects of
extravasation (leakage) associated with
anthracycline chemotherapy
• Can limit damage from extravasation
and enable patients to continue treatment
• Anthracyclines are widely used in the
treatment of breast cancer, soft tissue
sarcomas, and lymphomas
Portfolio Expansion
Strategy
PRODUCT
PORTFOLIO
ACQUIRE
Under-Promoted,
Approved Brands
IDENTIFY
Late Stage Candidates
EXPAND
Existing Products
DEVELOP
Early-Stage Candidates
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Ifetroban
Overview
• A potent, selective antagonist of thromboxane receptor (TPr)
• Initially developed by Bristol-Myers Squibb as an anti-platelet agent
• Safety is well-established in 26 clinical studies with over 1,300 subjects
• Cumberland is collaborating with Vanderbilt, Harvard, Scripps and other academic centers
• Cumberland successfully manufactures both IV and oral formulations
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Rationale for
Ifetroban
Ifetroban Inhibits The Thromboxane Receptor (TPr):
• Antagonist of smooth muscle contraction, platelet aggregation, and inflammation
• New data also demonstrates impact on fibrosis
Hepatorenal Syndrome: Renal Vasoconstriction, Liver Inflammation, & Fibrosis
Aspirin Exacerbated Respiratory Disease (AERD): Airway Constriction,
Vasoconstriction, & Cellular Infiltration/Inflammation
Systemic Sclerosis: Vasoconstriction, Autoimmune Inflammatory Process, & Fibrosis
Portal Hypertension: Endothelial Dysfunction, Liver Fibrosis, & Inflammation
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Hepatoren®
in HRS
• Patients with HRS have severe multi-organ dysfunction
• No FDA approved treatment for this unmet medical need
• Orphan Drug candidate, with an estimated patient population of 175,000
• Cumberland has completed initial Phase IIA study
• Ifetroban was well-tolerated across all doses with no safety concerns
• Showed signals of improved kidney function
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Boxaban®
in AERD
14
• Chronic condition characterized by asthma, sinus infections, and nasal polyps
• No FDA approved treatment for this unmet medical need
• Potential Orphan Drug candidate
• Cumberland has completed initial Phase IIA study
• Ifetroban was well-tolerated with no safety concerns
• Showed signals of efficacy and improved respiratory function
Vasculan®
in SSc
• Chronic, life-threatening multi-system autoimmune
• Highest death rate of any autoimmune disease
• No FDA approved treatment for this unmet medical need
• Orphan Drug candidate, with an estimated patient population of 165,000
• Cumberland is currently conducting an initial Phase IIA study
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Portaban™
in PH
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• The most serious complications of liver cirrhosis
• Median survival is 6 years from diagnosis
• No FDA approved treatment for this unmet medical need
• Orphan Drug candidate, with an estimated patient population of 100,000
• Cumberland is currently conducting an initial Phase IIA study
Ifetroban
Development Pipeline
Preclinical IND Phase I NDA Phase II
Safety PK
Phase Il
Efficacy
Phase III
Hepatoren® (hepatorenal syndrome)
Boxaban® (aspirin-exacerbated respiratory disease)
Vasculan™ (systemic sclerosis)
Portaban™ (portal hypertension)
Phase II
Study Data is
Next Milestone
Anti-fibrosis
Anti-inflammatory
Existing Safety Profile of >1,300 Patients
Financial
Overview
($ in millions) 3Q 2017 YTD 2017
N e t R e v e n u e s $11.2 $29.5
C o s t o f P r o d u c t s S o l d 2.2 5.2
G r o s s P r o f i t $9.0 $24.3
S e l l i n g & M a r k e t i n g $6.2 $16.2
R e s e a r c h & D e v e l o p m e n t 0.9 2.9
G e n e r a l A d m i n i s t r a t i v e 2.1 6.6
A m o r t i z a t i o n 0.6 1.8
O p e r a t i n g I n c o m e ( L o s s ) ($0.8) ($3.2)
A d j u s t e d E a r n i n g s $0.1 $0.4
A d j u s t e d E a r n i n g s P e r S h a r e $0.01 $0.02
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Summary
Balance Sheet
($ IN MILLIONS) FY as of Sept 30, 2017
T O TA L A S S E T S $ 9 0 . 4
C A S H & S E C U R I T I E S 5 0 . 1
T O TA L D E B T
8 . 0
R E TA I N E D E A R N I N G S 1 2 . 5
TO TA L E Q U I T Y
*Continued Share Repurchase Program
*Tax carry forward credits of $44 million available
6 5 . 1
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Cumberland
Moving Forward
Diverse product portfolio focused in large and growing markets
Proven development and commercialization capabilities
Various initiatives in place to support near-term growth
Four Phase II products in development with upcoming study milestones
Strong network of strategic partnerships
Strong financial position with positive net cash flows from operations
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Investor Presentation
Appendix
• Unique crystalline formulation of lactulose
• Prescription strength laxative
• Clinically proven increases in patient satisfaction
• Acquired from Mylan Laboratories
• Repositioned to reflect branded status
• New pricing allowed co-pay support
• Expanding Managed Care coverage
23
• IV treatment for hyponatremia
• Patented, branded hospital product
• Delivered in a pre-mixed bag
• Promotes free water secretion in hospitalized patients suffering
from an imbalance of sodium and water levels
• Condition results from a variety of critical care conditions including
ICU, neurology, nephrology, & oncology
• Acquired from Astellas
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9 8
Pills Per Day
H. pylori Treatment
for patients with duodenal ulcer disease
Newest treatment for
Helicobactor pylori (H.
pylori) a frequent cause
of stomach ulcers
A triple therapy brand
• Omeprazole (Prilosec)
• Clarithromycin
• Amoxicillin
Requires fewer pills
than other products that
treat H. pylori
Shorter course of
therapy enhances
compliance
25
Partnership
Strategy Slide
Streamline Operational Effectiveness and Expanding
Market Penetration via Partnerships
U.S. distribution
partnership with
Cardinal Health
Strategic alliance for
brand representation
with the U.S.
Co-Promotional partnership
to expand our hospital
coverage across the U.S.
26
Co-Promotional partnership
to expand medical
specialties covered in
support of Kristalose
International
Network
Bringing our medicines to patients throughout the
world through a growing network of distinguished
international partners
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