Cumberland Pharmaceuticals Inc. · NASDAQ:CPIX
Cumberland Pharmaceuticals — Investor Presentation (December 2017)
27 slides from Cumberland Pharmaceuticals's investor presentation, Dec 8, 2017
Slide 1: Investor Presentation
CUMBERLAND* Investor Presentation — se
Slide 2: Safe Harbor Statement
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, uncertaint
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 Acetadote® (Acetaminophen Toxicity) Caldolor® (Pain and Fever) Vaprisol® (Hyponatremia) Ethyol® (Amifostine) Totect® (Dexrazoxane) GASTROENTEROLOGY Kristalose® (Acute/Chronic Constipation) Omeclamox®-Pak (H. pylori) 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: Oncology
(4m CUMBERLAND* PHARMACEUTICALS ONCOLOGY
Slide 8: Ethyol
• 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
Slide 9: 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 10: Portfolio Expansion Strategy
Portfolio Expansion Strategy PRODUCT PORTFOLIO ACQUIRE Under-Promoted, Approved Brands IDENTIFY Late Stage Candidates EXPAND Existing Products DEVELOP Early-Stage Candidates 10
Slide 11: 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 12: 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 13: 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 14: Boxaban in AERD
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 • Sh
Slide 15: 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 16: Portaban in PH
Portaban™ in PH 16 • 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 II
Slide 17: Ifetroban Development Pipeline
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-fib
Slide 18: Financial Overview
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 $16.2 R e s e a r c h & D e v e l o p m e n t 0.9 2.9 G e n e r a l A d m i n i s t r a t i v e 2.
Slide 19: Summary Balance Sheet
Summary Balance Sheet ($ 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
Slide 20: Cumberland Moving Forward
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 par
Slide 21: Cumberland
CUMBERLAND* Investor Presentation — se
Slide 22: Appendix
Appendix
Slide 23: 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 23
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
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.
Slide 26: Partnership Strategy
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
Slide 27: International Network
International Network Bringing our medicines to patients throughout the world through a growing network of distinguished international partners 27
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