Cumberland Pharmaceuticals Inc. · NASDAQ:CPIX
Cumberland Pharmaceuticals — Investor Presentation (June 2018)
32 slides from Cumberland Pharmaceuticals's investor presentation, Jun 1, 2018
Slide 1: Investor Presentation
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Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains forward-looking statements Important factors that could cause actual results to differ concerning our approved products and product materially from those indicated by such forward-looking development, our technology, our competitors, our statements in
Slide 3: Company Overview
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 produ
Slide 4: Marketed Brands
Marketed Brands HOSPITAL GASTROENTEROLOGY ONCOLOGY Acetadote® Kristalose® Ethyol® (Acetaminophen Toxicity) (Acute/Chronic Constipation) (Amifostine) Caldolor® Omeclamox®-Pak Totect® (Pain and Fever) (H. pylori) (Dexrazoxane) Vaprisol® (Hyponatremia) 4
Slide 5: Acetadote
• 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 significan
Slide 6: Caldolor
• 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 manag
Slide 7: Kristalose
• 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 7
Slide 8: Oncology
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Slide 9: Ethyol re-launch
• 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 9
Slide 10: Portfolio Expansion Strategy
Portfolio Expansion Strategy IDENTIFY ACQUIRE Late Stage Candidates Under-Promoted, PRODUCT Approved Brands PORTFOLIO EXPAND DEVELOP Existing Products Early-Stage Candidates 10
Slide 11: Acquisition Initiative
Acquisition Initiative Active, ongoing initiative to identify, evaluate and acquire/license new products into the portfolio Source opportunities through direct efforts and intermediaries GOAL TO ADD ONE NEW Seek commercial and late stage development PRODUCT PER YEAR assets that fit our strategy and f
Slide 12: Methotrexate delivery with Nordic Group
• New delivery of methotrexate designed for the treatment of various forms of arthritis • Exclusive U.S. rights through a long-term partnership with the Nordic Group (based in Europe) • Widely used throughout Europe with a strong brand presence • The U.S. methotrexate market is seeing significant gr
Slide 13: Collaboration Partners
Collaboration Partners Vanderbilt University Nashville University of Tennessee University of Tennessee Health Science Center Knoxville Memphis University of Mississippi Oxford / Jackson Louisiana State University Health Sciences New Orleans 13
Slide 14: Ifetroban Overview
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 o
Slide 15: Rationale for Ifetroban
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 Exacerbate
Slide 16: Ifetroban Development Pipeline
Ifetroban Existing Safety Profile of >1,300 Patients Development Pipeline Preclinical IND Phase I Phase II Phase Il Phase III NDA Safety PK Efficacy Hepatoren® (hepatorenal syndrome) Phase II Boxaban® (aspirin-exacerbated respiratory disease) Study Data is Next Milestone Vasculan® (systemic sclerosi
Slide 17: Financial Overview
Financial Overview ($ in millions) FY 2017 N e t R e v e n u e s $41.2 C o s t o f P r o d u c t s S o l d 7.4 G r o s s P r o f i t $33.8 S e l l i n g & M a r k e t i n g $21.5 R e s e a r c h & D e v e l o p m e n t 3.9 G e n e r a l A d m i n i s t r a t i v e 10.0 A m o r t i z a t i o n 2.4 O
Slide 18: Summary Balance Sheet
Summary Balance Sheet ($ IN MILLIONS) FY as of Dec 31, 2017 C A S H & S E C U R I T I E S $ 5 0 . 1 T O T A L A S S E T S 9 3 . 2 T O TA L L I A B I L I T I E S 9 . 8 R E TA I N E D E A R N I N G S 11 . 7 T OTA L E Q U I T Y 6 3 . 9 *Continued Share Repurchase Program *Tax carry forward credits of $
Slide 19: Building Our Product Portfolio
Building Our Product Portfolio Ifetroban N.G.P. In-Line Brands Deploying a Multifaceted Strategy to Drive Value Creation
Slide 20: Cumberland Moving Forward
Cumberland Moving Forward Diverse product portfolio with 7 FDA approved brands 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 financial position with positive n
Slide 21: (tm. CUMBERLAND‘
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Slide 22: Appendix
Appendix
Slide 23: Totect
• 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 tis
Slide 24: Vaprisol
• 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,
Slide 25: Omeclamox-Pak
Newest treatment for Helicobactor pylori (H. pylori) a frequent cause of stomach ulcers H. pylori Treatment for patients with duodenal ulcer disease A triple therapy brand • Omeprazole (Prilosec) • Clarithromycin • Amoxicillin Requires fewer pills than other products that treat H. pylori Pills Per D
Slide 26: Partnership Strategy
Partnership Strategy Slide Streamline Operational Effectiveness and Expanding Market Penetration via Partnerships U.S. distribution Co-Promotional partnership partnership with to expand our hospital Cardinal Health coverage across the U.S. Co-Promotional partnership Strategic alliance for to expand
Slide 27: International Distribution
Bringing our medicines to patients throughout the International world through a growing network of distinguished Distribution international partners Europe Asia North America Oceania South America Middle East 27
Slide 28: Hepatoren in HRS
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 dose
Slide 29: Boxaban in AERD
Boxaban® in AERD • 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 • Showe
Slide 30: Vasculan in SSc
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 I
Slide 31: Portaban in PH
Portaban® in PH • 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 s
Slide 32: Reconciliation of Net Income to Adjusted Earnings
Reconciliation of Net Income to Adjusted Earnings ($ in thousands except per share data) FY 2017 N e t I n c o m e ( L o s s ) A t t r i b u t e d t o t h e C o m m o n S h a r e h o l d e r s ($7,979) N e t L o s s a t S u b s i d i a r y A t t r i b u t a b l e t o N o n c o n t r o l l i n g I n
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