Financial Position and Assets - As of December 31, 2022, intangible assets related to acquisitions represented approximately 33% of total assets [286]. - The aggregate market value of common stock held by non-affiliates as of June 30, 2022, was $17.3 million [428]. - The number of shares of the registrant's Common Stock outstanding as of March 7, 2023, was 14,395,401 [428]. Capital Requirements and Funding - The company may need to raise additional funds to meet capital requirements for business operations and new pharmaceutical product development, which could lead to shareholder dilution [287]. - The company anticipates increased expenditures in drug discovery and development, particularly for clinical trials prior to regulatory approval [288]. - The company intends to continue significant investments in drug discovery and development, which may lead to future losses [314]. Corporate Governance and Control - As of December 31, 2022, officers and directors control approximately 41.81% of common stock, potentially influencing corporate decisions [291]. - The company has never paid cash dividends on its capital stock, indicating a focus on reinvestment [297]. Market Risks and Stock Performance - The market price of the company's common stock may fluctuate substantially, influenced by analyst reports and market conditions [292]. - The company may face challenges in maintaining its NASDAQ listing if it fails to meet minimum requirements, which could negatively impact stock liquidity and market price [294]. Financial Management and Risk Exposure - The company is exposed to market risk related to changes in interest rates on cash deposits and revolving credit facilities, focusing on principal preservation and liquidity [423]. - A portion of the company's research and development is performed abroad, exposing it to foreign currency risk [425]. - The company does not utilize derivative financial instruments to manage exposure to interest rate changes [423]. - The company emphasizes maximizing interest income through low-risk investments [423]. Regulatory and Reporting Status - The company is classified as a non-accelerated filer and a smaller reporting company under the Exchange Act [427]. - The company is not a well-known seasoned issuer as defined in Rule 405 of the Securities Act [426]. Forward-Looking Statements and Uncertainties - The company has made forward-looking statements regarding its future operations, which are subject to various risks and uncertainties [424]. - The company may incur significant losses in the future and may not achieve or maintain profitability due to uncertainties in generating commercially successful drug products [289]. Covenants and Obligations - The Revolving Credit Agreement imposes restrictive covenants that could adversely affect business operations if not complied with [298]. - The sum of individual amounts in the contractual cash obligations may not agree due to rounding [421].

Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) Q4 2022 Earnings Conference Call March 7, 2023 4:30 PM ET Company Participants Molly Aggas - Account Supervisor, Dalton Agency A.J. Kazimi - CEO Todd Anthony - VP, Organizational Development John Hamm - CFO Conference Call Participants Operator Good afternoon, and welcome to Cumberland Pharmaceuticals' 2022 Financial Report and Company Update. This call is being recorded at Cumberland's request and will be archived on the company's website for one year from toda ...

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, 2022 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 Inc. (Exact Name of Registrant as Specified In Its Charter) Tennessee 62-1765329 (State or ...

Cumberland Pharmaceuticals, Inc. (NASDAQ:CPIX) Q3 2022 Earnings Conference Call November 8, 2022 4:30 PM ET Company Participants Molly Aggas - Account Supervisor, Dalton Agency A. J. Kazimi - Founder, Chairman, President & CEO John Hamm - Senior Director of Finance & Accounting & CFO Conference Call Participants Operator Good afternoon, and welcome to Cumberland Pharmaceuticals' Third Quarter 2022 Financial Report and Company Update. This call is being recorded at Cumberland's request and will be archived ...

Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) Q2 2022 Results Conference Call August 9, 2022 4:30 PM ET Company Participants Molly Aggas - Account Supervisor, Dalton Agency A.J. Kazimi - Chief Executive Officer Todd Anthony - Vice President, Organizational Development John Hamm - Chief Financial Officer Operator Good afternoon, and welcome to Cumberland Pharmaceuticals Second Quarter 2022 Financial Report and Company Update. This call is being recorded at the company's request and will be archived on Cumber ...

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, 2022 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 Inc. (Exact Name of Registrant as Specified In Its Charter) Tennessee 62-1765329 (State or Othe ...

Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) Q1 2022 Results Earnings Conference Call May 10, 2022 4:30 PM ET Company Participants Molly Aggas - Account Supervisor, Dalton Agency A.J. Kazimi - Chief Executive Officer Todd Anthony - Vice President, Organizational Development John Hamm - Chief Financial Officer Operator Good afternoon, and thank you for joining Cumberland Pharmaceuticals First Quarter 2022 Financial Report and Company Update. This call is being recorded at the company's request and will be a ...

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 March 31, 2022 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 Inc. (Exact Name of Registrant as Specified In Its Charter) Tennessee 62-1765329 (State or Oth ...

| --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|-------|-------|-------|-------|-------|----------------------------------------------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 00 | 0 | (80) | | | | 中 CUMBERLAND® P H A R M A C E U T I C A L S | | | | | | | | | | Corporate Presentation | | | | | | | | | | Nasdaq CPIX | | | Safe Harbor Statement 2 This presentation contains forward-looking stateme ...

Part I [Business](index=4&type=section&id=Item%201.%20Business) Cumberland Pharmaceuticals specializes in acquiring, developing, and commercializing branded prescription products for acute care, gastroenterology, rheumatology, and oncology - **Cumberland focuses on acquiring, developing, and commercializing branded prescription drugs for hospital acute care, gastroenterology, rheumatology, and oncology**[11](index=11&type=chunk)[12](index=12&type=chunk) - **Cumberland markets eight FDA-approved brands: Acetadote®, Caldolor®, Kristalose®, Omeclamox®-Pak, RediTrex®, Sancuso®, Vaprisol®, and Vibativ®**[13](index=13&type=chunk) - **The company is advancing Phase II clinical programs for ifetroban candidates in Duchenne Muscular Dystrophy (DMD), Systemic Sclerosis (SSc), and Aspirin-Exacerbated Respiratory Disease (AERD)**[13](index=13&type=chunk)[75](index=75&type=chunk) - **In late 2021, Cumberland acquired U.S. rights to Sancuso®, an FDA-approved patch for preventing chemotherapy-induced nausea and vomiting, with the transaction closing in January 2022**[62](index=62&type=chunk) [Products](index=6&type=section&id=Products) The company markets eight FDA-approved products, including Acetadote, Caldolor, and Vibativ, with some facing recent supply chain disruptions Marketed Products and Indications | Products | | :--- | | **Acetadote®** (acetylcysteine) injection, for acetaminophen poisoning | | **Caldolor®** (ibuprofen) injection, for pain and fever | | **Kristalose®** (lactulose) for oral solution, for constipation | | **Omeclamox®-Pak**, for H. pylori infection and duodenal ulcer disease | | **RediTrex®** (methotrexate) injection, for arthritis and psoriasis | | **Sancuso®** (granisetron) transdermal system, for chemotherapy-induced nausea and vomiting | | **Vaprisol®** (conivaptan) injection, for hyponatremia | | **Vibativ®** (telavancin) injection, for serious bacterial infections | - **Omeclamox-Pak became unavailable due to its packager suspending operations in 2020, leading to inventory depletion**[54](index=54&type=chunk) - **Vaprisol is currently unavailable as all inventory was shipped in 2021, pending FDA approval for a new manufacturing facility**[68](index=68&type=chunk) - **The national launch of RediTrex was delayed by the pandemic and implemented in Q4 2021**[61](index=61&type=chunk) [Pipeline](index=10&type=section&id=Pipeline) The clinical pipeline focuses on ifetroban in Phase II trials for AERD, SSc, DMD, and PF-ILDs, alongside a completed Phase II study for a cholesterol-reducing agent - **The company sponsors Phase II clinical programs for ifetroban candidates in Aspirin-Exacerbated Respiratory Disease (AERD), Systemic Sclerosis (SSc), and Duchenne Muscular Dystrophy (DMD)**[75](index=75&type=chunk) - **In September 2021, the Board approved a new clinical program for ifetroban to treat Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)**[89](index=89&type=chunk) - **A Phase II study for a new hospital cholesterol-reducing agent has completed patient enrollment, with next steps under determination**[92](index=92&type=chunk)[155](index=155&type=chunk) [Sales and Marketing](index=14&type=section&id=Sales%20and%20Marketing) Cumberland employs approximately 60 sales professionals across Hospital, Field, and Oncology divisions, with a new oncology team formed in early 2022 for Sancuso - **The company's sales and marketing organization comprises approximately 60 professionals across Hospital, Field, and Oncology divisions**[103](index=103&type=chunk) - **A new oncology sales force was formed in early 2022 to promote the Sancuso brand**[104](index=104&type=chunk) [Material Customers](index=14&type=section&id=Material%20Customers) The company's primary customers are U.S. wholesale pharmaceutical distributors, with three customers accounting for a significant portion of 2021 gross revenues Revenue Concentration by Customer (2021) | Customer | % of Gross Revenue | | :--- | :--- | | Customer 1 | 27% | | Customer 2 | 24% | | Customer 3 | 20% | [Patents, Trademarks and Other Intellectual Proprietary Rights](index=23&type=section&id=Patents%2C%20Trademarks%20and%20Other%20Intellectual%20Proprietary%20Rights) Cumberland protects products via patents and trademarks, with key patents for Acetadote, Caldolor, Vibativ, and Sancuso, but none for Vaprisol, RediTrex, Omeclamox-Pak, or Kristalose - **The '445 Acetadote Patent, covering the 200 mg/ml formulation, expires in August 2025 and has been upheld in court**[184](index=184&type=chunk)[190](index=190&type=chunk)[194](index=194&type=chunk) - **Caldolor is protected by multiple patents, with some extending intellectual property protection to March 2032**[198](index=198&type=chunk) - **Vibativ is covered by U.S. Patent 7,531,623, including composition of matter claims, expiring in January 2027**[204](index=204&type=chunk) - **The company holds no issued patents for Vaprisol, RediTrex, Omeclamox-Pak, and Kristalose products**[206](index=206&type=chunk) [Competition](index=27&type=section&id=Competition) The company faces intense competition from branded drugs, generics, and alternative treatments across its product portfolio, including Acetadote, Caldolor, and Vibativ - **Acetadote competes with generic versions of its old formulation and an Authorized Generic of its new EDTA-free formulation**[212](index=212&type=chunk)[213](index=213&type=chunk) - **Caldolor's primary competitors include generic injectable opioids, ketorolac, IV acetaminophen (Ofirmev®), and other branded non-narcotic analgesics**[214](index=214&type=chunk)[215](index=215&type=chunk) - **Vibativ's major competitors include generic antibiotics like vancomycin, linezolid, and daptomycin, and newer branded agents**[235](index=235&type=chunk)[236](index=236&type=chunk) [Government Regulation](index=30&type=section&id=Government%20Regulation) The company's operations are extensively regulated by the FDA, involving rigorous approval processes, ongoing post-approval compliance, and adherence to healthcare legislation like the Physician Payments Sunshine Act - **The company is subject to extensive regulation by U.S. authorities, including the FDA, and other federal, state, and local laws**[238](index=238&type=chunk)[239](index=239&type=chunk)[240](index=240&type=chunk) - **Cumberland utilized the 505(b)(2) NDA pathway for Acetadote, Caldolor, and RediTrex approvals, allowing reliance on existing data not generated by the applicant**[259](index=259&type=chunk)[260](index=260&type=chunk) - **The company must comply with the Physician Payments Sunshine Act, requiring reporting of transfers of value to physicians and teaching hospitals to CMS**[273](index=273&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from the COVID-19 pandemic, supply chain dependence, generic competition, acquisition and pipeline development uncertainties, and stringent regulation - **The COVID-19 pandemic has adversely impacted business through revenue loss, supply interruptions, clinical trial delays, and potential future liquidity effects**[313](index=313&type=chunk)[314](index=314&type=chunk) - **Dependence on third-party manufacturers for all products poses significant supply disruption risks, as seen with Omeclamox-Pak and Vaprisol**[324](index=324&type=chunk)[329](index=329&type=chunk)[330](index=330&type=chunk) - **Approval and sale of generic equivalents for branded products could significantly reduce revenues and market share due to lower costs**[342](index=342&type=chunk)[343](index=343&type=chunk) - **Future growth depends on successfully acquiring and integrating new products, which involves competition and financial and operational risks**[347](index=347&type=chunk)[348](index=348&type=chunk) - **Ifetroban product candidates face a long, expensive, and uncertain development process with a high risk of failure, as they are not yet approved for sale**[351](index=351&type=chunk) [Properties](index=62&type=section&id=Item%202.%20Properties) As of December 31, 2021, Cumberland leases 25,500 sq ft for its Nashville headquarters, with a new 16,631 sq ft lease commencing in late 2022 - **The company leases 25,500 sq ft for its Nashville, TN headquarters, with the lease expiring in October 2022**[493](index=493&type=chunk) - **A new lease for 16,631 sq ft at the Broadwest development in Nashville has been signed for a new corporate headquarters, commencing in late 2022**[493](index=493&type=chunk) [Legal Proceedings](index=62&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in ongoing legal proceedings defending its Acetadote patents and litigation with Melinta Therapeutics - **The company is involved in legal proceedings to defend its Acetadote patents**[495](index=495&type=chunk) - **The company is also involved in litigation with Melinta Therapeutics, as detailed in the Notes to Consolidated Financial Statements**[495](index=495&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=62&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Cumberland's common stock trades on Nasdaq under 'CPIX', has never paid dividends, and repurchased **$1.4 million** in shares in 2021 under its program - **The company's common stock trades on the Nasdaq Global Select Market under the symbol 'CPIX'**[498](index=498&type=chunk) - **The company has never declared or paid any cash dividends on its common stock**[499](index=499&type=chunk) - **In 2021, the company repurchased 438,359 shares of common stock for approximately $1.4 million under its share repurchase program**[502](index=502&type=chunk) Share Repurchases in Q4 2021 | Period | Total Number of Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | October | 33,071 | $2.74 | | November | 35,095 | $2.56 | | December | 43,656 | $4.68 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=64&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In 2021, net revenues decreased to **$36.0 million**, resulting in a **$5.6 million** net loss, while the company maintained strong liquidity and saw its **$2.2 million** PPP loan forgiven [Results of Operations](index=70&type=section&id=Results%20of%20Operations) Net revenues decreased to **$36.0 million** in 2021 from **$37.4 million** in 2020, resulting in a **$5.6 million** net loss, while 2020 revenues grew to **$37.4 million** from **$34.4 million** in 2019 Net Revenues by Product (2021 vs. 2020) | Product | 2021 Net Revenue ($M) | 2020 Net Revenue ($M) | Change ($M) | | :--- | :--- | :--- | :--- | | Kristalose | 16.0 | 15.6 | 0.4 | | Vibativ | 11.7 | 10.9 | 0.8 | | Caldolor | 5.0 | 5.3 | (0.3) | | Acetadote | 0.9 | 1.9 | (1.0) | | Vaprisol | 1.9 | 1.1 | 0.8 | | Omeclamox-Pak | (0.4) | 0.3 | (0.7) | | RediTrex | 0.1 | 0.9 | (0.8) | | **Total Net Revenues** | **36.0** | **37.4** | **(1.4)** | Net Revenues by Product (2020 vs. 2019) | Product | 2020 Net Revenue ($M) | 2019 Net Revenue ($M) | Change ($M) | | :--- | :--- | :--- | :--- | | Kristalose | 15.6 | 12.9 | 2.7 | | Vibativ | 10.9 | 8.7 | 2.2 | | Caldolor | 5.3 | 5.2 | 0.1 | | Acetadote | 1.9 | 3.8 | (1.9) | | **Total Net Revenues** | **37.4** | **34.4** | **3.0** | - **In 2021, cost of products sold as a percentage of net revenues increased to 24.5% from 23.1% in 2020, primarily due to a product mix shift towards Vibativ**[556](index=556&type=chunk) [Liquidity and Capital Resources](index=76&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2021, cash and cash equivalents were **$27.0 million**, with working capital at **$26.4 million**, supported by an expanded **$20 million** revolving credit facility and a forgiven **$2.2 million** PPP loan Liquidity Summary | Metric | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $27,040,816 | $24,753,796 | | Working capital | $26,409,053 | $24,302,146 | | Revolving line of credit availability | $5,000,000 | $0 | - **The revolving credit agreement with Pinnacle Bank was amended to increase the principal amount to $20 million and extend maturity to October 1, 2024**[586](index=586&type=chunk) - **On June 11, 2021, the company received formal notice that the full $2,187,140 PPP loan received in 2020 was forgiven**[593](index=593&type=chunk)[776](index=776&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=80&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces interest rate risk from its variable-rate revolving credit facility, with **$15.0 million** outstanding, and minimal foreign currency exchange rate risk - **The company is exposed to interest rate risk on its revolving credit facility, with $15.0 million outstanding as of December 31, 2021**[606](index=606&type=chunk) - **The company's exposure to foreign currency fluctuation is minimal, with purchases having a maximum exposure of 90 days**[608](index=608&type=chunk) [Financial Statements and Supplementary Data](index=80&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents consolidated financial statements for 2019-2021, including auditor reports and notes, with customer allowances identified as a critical audit matter for 2021 - **Management concluded that as of December 31, 2021, the company's internal control over financial reporting was effective based on the COSO framework**[638](index=638&type=chunk) - **BKD, LLP identified 'Customer Allowances for Chargebacks, Discounts and Damaged Goods, and Accruals for Rebates, Coupons, Product Returns, and Certain Fees' as a critical audit matter for the 2021 audit**[648](index=648&type=chunk)[649](index=649&type=chunk)[650](index=650&type=chunk) [Controls and Procedures](index=80&type=section&id=Item%209A.%20Controls%20and%20Procedures) The CEO and CFO concluded that disclosure controls and procedures were effective as of December 31, 2021, with no material changes in Q4 2021 - **The CEO and CFO concluded that as of December 31, 2021, the company's disclosure controls and procedures were effective**[610](index=610&type=chunk) - **No material changes in internal control over financial reporting occurred during Q4 2021**[612](index=612&type=chunk) Part III [Directors, Executive Officers, Compensation, and Corporate Governance](index=81&type=section&id=Items%2010-14) Information for directors, executive officers, compensation, and corporate governance is incorporated by reference from the 2022 proxy statement - **Information for Items 10 through 14 is incorporated by reference from the registrant's Proxy Statement for its 2022 annual meeting of shareholders**[616](index=616&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=82&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all exhibits and financial statement schedules filed with the 10-K, including material contracts and Sarbanes-Oxley certifications - **This section contains the list of financial statements, schedules, and exhibits filed with the 10-K**[619](index=619&type=chunk) - **Key exhibits include the Asset Purchase Agreement for Sancuso, amendments to the Revolving Credit Loan Agreement, and various employment and compensation plan agreements**[620](index=620&type=chunk)[624](index=624&type=chunk)[626](index=626&type=chunk)