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): June 1, 2018 (June 1, 2018) | |
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) | |||
(615) 255-0068 | |||
(Registrant’s telephone number, including area code) | |||
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:
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
The information contained in this Current Report on Form 8-K (including the exhibits hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.
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 are presenting the Company to new investors utilizing the updated presentation which is furnished as Exhibit 99.1 and is also on the Company's website, www.cumberlandpharma.com.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit No. | Description | |
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. | ||||||
Dated: June 1, 2018 | By: | /s/ Michael Bonner | ||||
Michael Bonner | ||||||
Chief Financial Officer | ||||||
Investor Presentation
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 include, among others, those set forth under intellectual property, our financial condition and our plans the headings "Risk factors" and "Management's discussion for research and development programs that involve risks, and analysis of financial condition and results of uncertainties and assumptions. These statements are operations" in our Form 10-K and Form 10-Q Reports on based on the current estimates and assumptions of the file with the SEC. The Company does not undertake any management of Cumberland Pharmaceuticals as of the obligation to release publicly any revisions to these date of this presentation and are subject to uncertainty and forward-looking statements to reflect events or changes in circumstances. Given these uncertainties, you circumstances after the date hereof or to reflect the should not place undue reliance upon these forward- occurrence of unanticipated events. All statements looking statements. Such forward-looking statements are contained in this presentation are made only as of the date subject to risks, uncertainties, assumptions and other of this presentation. For more information on our brands, factors that may cause the actual results of Cumberland including full prescribing and safety information, please see Pharmaceuticals to be materially different from those the links to the product websites which can be found at reflected in such forward-looking statements. www.cumberlandpharma.com. 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 GASTROENTEROLOGY ONCOLOGY Acetadote® Kristalose® Ethyol® (Acetaminophen Toxicity) (Acute/Chronic Constipation) (Amifostine) Caldolor® Omeclamox®-Pak Totect® (Pain and Fever) (H. pylori) (Dexrazoxane) Vaprisol® (Hyponatremia) 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 5
• 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
• 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
• 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
Portfolio Expansion Strategy IDENTIFY ACQUIRE Late Stage Candidates Under-Promoted, PRODUCT Approved Brands PORTFOLIO EXPAND DEVELOP Existing Products Early-Stage Candidates 10
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 focus • Branded, Rx products in hospital acute care or through business development initiative or internal product gastroenterology development • Sales of $5-25 million or larger with attractive margins 11
• 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 growth • Preparing FDA submission for approval in the U.S. 12
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
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 14
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 15
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 sclerosis) Portaban® (portal hypertension) Anti-inflammatory Anti-fibrosis
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 p e r a t i n g I n c o m e ( L o s s ) ($4.0) A d j u s t e d E a r n i n g s * $0.1 *Represents a non-GAAP financial measure. For a reconciliation, see the Appendix. 17
Summary Balance Sheet ($ 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 $44 million available 18
Building Our Product Portfolio Ifetroban N.G.P. In-Line Brands Deploying a Multifaceted Strategy to Drive Value Creation
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 net cash flows from operations Valuation gap given assets, cash, sales, and pipeline 20
Investor Presentation
Appendix
• 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
• 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 24
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 Day Shorter course of 998 therapy enhances compliance 25
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 medical brand representation specialties covered in with the U.S. support of Kristalose 26
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
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 28
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 • Showed signals of efficacy and improved respiratory function 29
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 30
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 study 31
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 t e r e s t s 71 N e t I n c o m e ( L o s s ) ($8,050) I n c o m e T a x E x p e n s e ( B e n e f i t ) $4,175 D e p r e c i a t i o n a n d A m o r t i z a t i o n 2,648 S h a r e - B a s e d C o m p e n s a t i o n 1,115 O t h e r A d j u s t m e n t s t o N e t I n c o m e 372 I n t e r e s t I n c o m e (299) I n t e r e s t E x p e n s e 93 A d j u s t e d E a r n i n g s $54 32