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Cumberland Pharmaceuticals(CPIX) - 2019 Q4 - Earnings Call Presentation
2020-03-19 18:06
Company Overview - Cumberland Pharmaceuticals is a specialty pharmaceutical company with a portfolio of seven FDA-approved products[3] - The company has several near-term catalysts for new growth opportunities, including Vibativ post-acquisition integration and market expansion, Next Generation Caldolor product, and RediTrex methotrexate product line[3] - Cumberland has five Phase II products in development with upcoming study milestones[3] - The company has a strong financial position and positive net cash flows from operations[3] Product Portfolio and Strategy - The company's mission is to advance patient care through the delivery of high-quality medicines[4] - The company's strategy is to build a portfolio of specialized biopharmaceutical brands through product development and acquisition[4] - The company aims to add one new product per year through business development or internal product development, targeting branded Rx products in hospital acute care or gastroenterology with sales of $5-25 million or larger with attractive margins[8] - Caldolor has administered over 2.3 million doses[6] Financial Overview - In 2019, Cumberland Pharmaceuticals had net revenues of $47.5 million[16] - The company's total assets were $104.5 million and total liabilities were $53.5 million as of December 31, 2019[16] - The company has tax carry forward credits of $44 million available[17]
Cumberland Pharmaceuticals(CPIX) - 2019 Q4 - Earnings Call Transcript
2020-03-19 02:50
Financial Data and Key Metrics Changes - Net revenues for Q4 2019 were $13.7 million, a slight increase from $13.5 million in the prior year, while full-year revenues reached over $47 million, up 17% from approximately $40 million in 2018, achieving the goal of double-digit revenue growth [11][30][31] - Adjusted earnings for Q4 2019 were $1.5 million, consistent with the prior year, while full-year adjusted earnings were $5 million or $0.32 per share, a significant increase from a loss of $0.5 million or $0.03 per share in 2018 [11][31] Business Line Data and Key Metrics Changes - For Q4 2019, revenues by product included $4.4 million for Ethyol, $3.2 million for Kristalose, $2.5 million for Vibativ, $1.7 million for Caldolor, and $1.2 million for Acetadote [30] - Full-year revenues by product included $12.9 million for Kristalose, $12.8 million for Ethyol, $8.7 million for Vibativ, $5.2 million for Caldolor, and $3.8 million for Acetadote [30] Market Data and Key Metrics Changes - The company finalized international agreements for Vibativ with partners in the Middle East, Russia, and India, enhancing its international presence [12] - In China, WinHealth Pharmaceuticals will manage Acetadote and Caldolor brands, contributing to the company's R&D initiatives [12] Company Strategy and Development Direction - The company aims to build a specialty pharma business focused on sustained growth and profitability, with key catalysts including the Vibativ acquisition and the launches of Caldolor and RediTrex [36][37] - The strategic review led to a focus on three key acute care brands: Caldolor, Vibativ, and Vaprisol, which are expected to provide better growth opportunities [12][36] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the impact of the coronavirus outbreak on the economy but expressed confidence in the company's ability to maintain operations and support patient needs [7][38] - The company is targeting double-digit revenue growth for 2020 and aims to deliver positive cash flow while returning capital to shareholders [37] Other Important Information - The company returned U.S. rights to Ethyol and Totect, resulting in $5 million in payments over two years, and will present these as discontinued operations starting in 2020 [34][35] - The company has over $44 million in tax net operating loss carry-forwards from prior stock option exercises [35] Q&A Session Summary Question: Has there been any disruption due to tornadoes or COVID-19? - Management confirmed that the business was largely unaffected by tornadoes and emphasized ongoing efforts to manage operations during the COVID-19 outbreak [40][41] Question: Insight on the next-generation Caldolor launch? - Significant adoption of the new presentation was reported, with hospitals transitioning to the next-generation product due to its convenience [43] Question: How will Clinigen financial consideration be accounted for? - It will be considered discontinued operations, with revenue components included in the top line [44][45]
Cumberland Pharmaceuticals(CPIX) - 2019 Q3 - Quarterly Report
2019-11-13 22:19
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 001-33637 | --- | --- | |----------------------------------------------------------------------------|------------------------- ...
Cumberland Pharmaceuticals(CPIX) - 2019 Q3 - Earnings Call Transcript
2019-11-13 03:16
Cumberland Pharmaceuticals, Inc. (NASDAQ:CPIX) Q3 2019 Earnings Conference Call November 12, 2019 4:30 PM ET Company Participants Erin Gull – Corporate Relations A. J. Kazimi – Chief Executive Officer Marty Cearnal – Chief Commercial Officer Ines Macias-Perez – Principal Scientist, Product Development Michael Bonner – Chief Financial Officer Conference Call Participants Andrew D'Silva – B. Riley FBR Operator Thank you for joining the Cumberland Pharmaceuticals Third Quarter 2019 Financial Report and Company ...
Cumberland Pharmaceuticals(CPIX) - 2019 Q2 - Earnings Call Transcript
2019-08-15 02:05
Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) Q2 2019 Earnings Conference Call August 14, 2019 4:30 PM ET Company Participants Erin Gull - Corporate Relations A.J. Kazimi - CEO Marty Cearnal - Chief Commercial Officer Michael Bonner - CFO Conference Call Participants Operator Thank you for joining the Cumberland Pharmaceuticals Second Quarter 2019 Financial Report and Company Update Conference Call. Please stay advice that this call is being recorded at the company’s request and will be archived on Cumberla ...
Cumberland Pharmaceuticals(CPIX) - 2019 Q2 - Quarterly Report
2019-08-14 21:28
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 001-33637 | --- | --- | |----------------------------------------------------------------------------------------------------------- ...
Cumberland Pharmaceuticals(CPIX) - 2019 Q1 - Quarterly Report
2019-05-15 21:12
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ý QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 001-33637 | --- | --- | |---------------------------------------------------------------------------------------------------------- ...
Cumberland Pharmaceuticals(CPIX) - 2018 Q4 - Annual Report
2019-03-11 23:12
Product Portfolio - The company markets eight FDA approved products in the United States, including Acetadote® for acetaminophen poisoning and Caldolor® for pain and fever[11]. - Acetadote has been a standard of care for treating acetaminophen poisoning since its introduction in 2004, with significant market share maintained through an EDTA-free formulation[19][23]. - Caldolor was the first injectable product approved in the U.S. for both pain and fever, with FDA approval received in 2009[26]. - Kristalose, a prescription laxative, is the only product available in pre-measured powder packets, with 77% of patients preferring it over syrup forms[32]. - Omeclamox-Pak is a branded prescription product for treating H. pylori infections and related duodenal ulcers, combining omeprazole, clarithromycin, and amoxicillin[36]. - Vaprisol, acquired in early 2014, is indicated for raising serum sodium levels in hospitalized patients with hyponatremia, and is the only intravenously administered branded treatment for this condition[41][42]. - Ethyol, acquired in May 2016, is indicated to reduce xerostomia in head and neck cancer patients and renal toxicity in ovarian cancer patients, with Cumberland responsible for all marketing and distribution in the U.S.[44]. - Totect is indicated for the treatment of extravasation associated with anthracycline chemotherapy, with its patent expiring in March 2020[189]. - Vibativ was acquired on November 12, 2018, and is approved for treating certain gram-positive infections[191]. Product Development and Pipeline - The product pipeline includes five Phase II candidates, such as Hepatoren® for hepatorenal syndrome and Boxaban® for aspirin-exacerbated respiratory disease[12]. - The company is actively pursuing opportunities to expand its products into additional patient populations through clinical trials and new indications[15]. - The company initiated clinical development of Hepatoren for treating hepatorenal syndrome, completing a Phase II study with 64 patients showing it was well tolerated[54][55]. - Boxaban, an oral formulation of ifetroban, is being evaluated for Aspirin-Exacerbated Respiratory Disease, with initial Phase II results indicating it was well tolerated[56][57]. - In 2018, the company completed a Phase I study for a new cholesterol-reducing agent, which showed a favorable safety profile[105]. Business Strategy - The company aims to maximize the potential of existing brands while expanding its portfolio through acquisitions and late-stage development candidates[15]. - Cumberland's growth strategy includes maximizing existing brands, acquiring complementary products, and progressing clinical pipelines through partnerships and collaborations[69][70][71]. - The acquisition of Vibativ has resulted in several new international partners and market opportunities[74]. - The company aims to build a portfolio of complementary, niche products through acquisitions and late-stage product development, focusing on under-promoted FDA-approved drugs[108]. Marketing and Distribution - The company has established a dedicated sales force for Kristalose and has entered into co-promotion agreements to expand its market reach[34]. - A co-promotion agreement with Piramal Critical Care has expanded the reach of Caldolor and Vaprisol to additional hospitals across the U.S.[109]. - The company has entered into co-promotion arrangements for Kristalose with 2R Investments, LLC and Foxland Pharmaceuticals, enhancing distribution and promotion efforts[115]. - Cardinal Health is responsible for the U.S. distribution logistics of the company's products, including warehousing and shipping[126]. Financial Position - The company maintains a strong financial position with favorable gross margins and a robust balance sheet, utilizing excess cash flow for an ongoing share repurchase program[75]. - In 2018, total revenue by customer for those representing 10% or more of consolidated gross revenues included Customer 1 at 26%, Customer 2 at 24%, Customer 3 at 25%, and Customer 4 at 11%[87]. International Expansion - Caldolor was approved for use in India in 2018, and the company is actively supporting existing international partners while seeking new companies for additional territories[92]. - The company has established an international network of partners, including Phebra Pty Ltd for Acetadote in Australia and New Zealand, and R-Pharm JSC for Vibativ in Russia[89]. Regulatory and Compliance - The company has a commitment to post-marketing activities for its products, including expanded labeling and safety data submissions to the FDA[20]. - The FDA requires post-market safety surveillance reporting, which may lead to withdrawal of approval after marketing begins[204]. - Clinical trials must adhere to Good Clinical Practice (GCP) requirements, and the FDA can halt trials if they do not comply[202]. - The FDA's review process for priority reviews aims to complete evaluations in six months for drugs that significantly improve safety or efficacy[202]. Intellectual Property - The company has filed for trademark registrations for various names and logos to protect its intellectual property[135]. - The 356 Acetadote Patent is scheduled to expire in May 2026, with ongoing litigation to defend its validity against multiple challengers[138]. - The company holds an exclusive, worldwide license to clinical data for intravenous ibuprofen from Vanderbilt University, with royalty obligations related to Caldolor[158]. - The 452 Caldolor Patent was issued on May 27, 2014, and is scheduled to expire in September 2029[158]. - The company obtained four additional patents for Caldolor during Q3 2015, with expiration dates set for March 2032[160]. - The 606 Vaprisol Patent, acquired in February 2014, is scheduled to expire in December 2019[165]. - The company has an exclusive license to promote, sell, and distribute Ethyol in the U.S., with several patents associated with it[166]. - The company has no issued patents for Omeclamox-Pak and Kristalose products, with pending applications for other products[169]. Philanthropy - The Cumberland Pharma Foundation was established in December 2017 with an initial grant of 50,000 shares to support its philanthropic activities[129].