Part I [Business](index=7&type=section&id=Item%201.%20Business) Eagle Pharmaceuticals is a fully integrated pharmaceutical company specializing in developing and commercializing innovative injectable medicines, primarily in the acute care and oncology sectors [Company Overview](index=7&type=section&id=Company%20Overview) Eagle Pharmaceuticals is a fully integrated pharmaceutical company with expertise in R&D, clinical development, manufacturing, and commercialization, marketing six FDA-approved products through partners and its direct sales force - The company has six commercially launched products: PEMFEXY®, vasopressin, Ryanodex®, Belrapzo, Bendeka, and Treakisym[28](index=28&type=chunk) - Acquired Acacia Pharma on June 9, 2022, adding two FDA-approved products, BARHEMSYS® and BYFAVO®, to expand its presence in the acute care space[29](index=29&type=chunk) - The clinical development pipeline includes CAL02 for severe pneumonia, landiolol for tachycardic supraventricular arrhythmias, and continued research on Ryanodex for conditions like nerve agent exposure and Alzheimer's disease[30](index=30&type=chunk) [Recent Developments](index=7&type=section&id=Recent%20Developments) In early 2023, Eagle announced its withdrawal from the vasopressin market, secured a new credit agreement, made strategic investments in Enalare Therapeutics, completed the Acacia Pharma acquisition, and advanced its pipeline - The company is withdrawing from the vasopressin market, with inventory expected to be depleted by the end of Q2 2023[31](index=31&type=chunk) - Entered into a new credit agreement on November 1, 2022, which includes a **$50 million term loan** and a **$100 million revolving credit facility**[32](index=32&type=chunk) - Committed to a potential equity investment of up to **$55 million** in Enalare Therapeutics and obtained an option to acquire the remaining shares of the company[34](index=34&type=chunk) - Completed the acquisition of Acacia Pharma on June 9, 2022, for approximately **$76 million in cash** and 516,024 shares of common stock, adding BARHEMSYS® and BYFAVO® to its portfolio[36](index=36&type=chunk) - Settled patent litigation with Accord Healthcare and Hospira, Inc. regarding BENDEKA®, granting licenses to market their respective products beginning January 17, 2028[42](index=42&type=chunk)[43](index=43&type=chunk) [Our Competitive Strengths and Strategy](index=10&type=section&id=Our%20Competitive%20Strengths%20and%20Strategy) Eagle's core strategy is to improve existing critical care and oncology injectable drugs, enhancing safety, convenience, and cost-effectiveness through formulation expertise, early market entry, and robust intellectual property - The company's purpose is to develop improved versions of existing injectable drugs to address issues like difficult preparation, waste, and safety concerns[50](index=50&type=chunk) - Key competitive strengths include early market entry before generic competition, the potential for regulatory exclusivity (**3 or 7 years**), and a strong intellectual property portfolio with over **70 owned or licensed U.S. patents**[56](index=56&type=chunk)[52](index=52&type=chunk) - Core strategies involve strengthening the product portfolio via R&D and acquisitions, retaining U.S. commercial rights while partnering abroad, and expanding its patent estate[55](index=55&type=chunk) [Our Products and Product Portfolio](index=12&type=section&id=Our%20Products%20and%20Product%20Portfolio) Eagle's portfolio focuses on acute care and oncology, featuring BARHEMSYS and BYFAVO from the Acacia acquisition, the bendamustine franchise, Ryanodex for malignant hyperthermia, and PEMFEXY for lung cancer - BARHEMSYS is the first and only FDA-approved product for Post-Operative Nausea and Vomiting (PONV) rescue after failed prophylaxis[63](index=63&type=chunk) - BYFAVO is a rapid onset/offset procedural sedative for procedures lasting 30 minutes or less, addressing an area with no innovation for over 20 years[64](index=64&type=chunk) - The bendamustine franchise (Belrapzo, Bendeka, Treakisym) offers liquid formulations that eliminate the need for reconstitution, reducing dosing errors and exposure to cytotoxic powders[69](index=69&type=chunk) - Ryanodex is a differentiated formulation of dantrolene sodium for malignant hyperthermia that reduces reconstitution and administration time from 15-20 minutes to **1 minute**. It is also being studied for treating brain damage from nerve agent exposure[76](index=76&type=chunk)[77](index=77&type=chunk) - PEMFEXY is a ready-to-dilute liquid formulation of pemetrexed for lung cancer, which avoids reconstitution time and safety concerns associated with the lyophilized version, Alimta[85](index=85&type=chunk)[82](index=82&type=chunk) [Sales and Marketing](index=17&type=section&id=Sales%20and%20Marketing) Eagle Pharmaceuticals commercializes products in the U.S. with an internal sales team, except for Bendeka, which is marketed by Teva, a partner on whom the company is highly dependent for revenue - The company utilizes an internal commercial team of **55 direct sales representatives** for products like Ryanodex, Belrapzo, BARHEMSYS, BYFAVO, and PEMFEXY[92](index=92&type=chunk) - The company is highly dependent on its commercial partner, Teva, for the marketing and sales of Bendeka, which represents a substantial portion of its revenue[93](index=93&type=chunk)[94](index=94&type=chunk) Customer Revenue Concentration | Customer | 2022 Revenue % | 2021 Revenue % | 2020 Revenue % | | :--- | :--- | :--- | :--- | | Teva | 33% | 66% | 67% | | Customer A | 19% | 7% | 10% | | Customer B | 12% | 9% | 5% | | Customer C | 12% | 4% | 2% | | Customer D | 9% | 8% | 9% | | Other | 15% | 6% | 7% | [Manufacturing](index=17&type=section&id=Manufacturing) Eagle Pharmaceuticals relies entirely on a network of third-party manufacturers for the production of its sterile injectable products, with its quality department ensuring regulatory compliance and internal standards - The company does not own manufacturing facilities and utilizes a network of third-party manufacturers for all product production[96](index=96&type=chunk) - Manufacturing of sterile injectables is complex, requires specialized expertise, and is subject to a high level of regulatory scrutiny[96](index=96&type=chunk) [Intellectual Property and Exclusivity](index=17&type=section&id=Intellectual%20Property%20and%20Exclusivity) The company's success hinges on its ability to obtain, maintain, and defend its intellectual property, including patents for key products like dantrolene, bendamustine, pemetrexed, amisulpride, and remimazolam, with expirations extending into the 2030s - Owns over **15 issued U.S. patents** for bendamustine formulations and methods of use, with potential expiration between 2031 and 2033[101](index=101&type=chunk) - Acquired Orange-Book listed patents for BARHEMSYS (amisulpride) and licensed patents for BYFAVO (remimazolam) through the Acacia Pharma acquisition, with expirations ranging from 2027 to 2041[103](index=103&type=chunk)[104](index=104&type=chunk) - Exclusively licenses a family of patents for dantrolene (Ryanodex) expected to expire no later than July 1, 2025[99](index=99&type=chunk) - Protects proprietary manufacturing processes and know-how through trade secrets and confidentiality agreements with employees, consultants, and third-party contractors[107](index=107&type=chunk)[108](index=108&type=chunk) [License Agreements](index=19&type=section&id=License%20Agreements) Eagle Pharmaceuticals maintains crucial license agreements, including those with Cephalon (Teva) for Bendeka and SymBio for Treakisym, generating significant royalty revenue, alongside recent deals for pipeline expansion and strategic investments - Under the amended Cephalon (Teva) license, Eagle receives a tiered royalty on Bendeka net sales in the U.S., starting at **30% in October 2019** and increasing to **32% over time**[116](index=116&type=chunk) - The SymBio license for bendamustine products in Japan includes upfront and milestone payments, plus tiered, low double-digit royalties on net sales[119](index=119&type=chunk)[123](index=123&type=chunk) - Amended its agreement with Robert One for PEMFEXY, modifying the royalty structure in exchange for a one-time **$15 million payment** made in January 2023[113](index=113&type=chunk)[114](index=114&type=chunk) - Entered into an agreement with Enalare, committing up to **$55 million in equity investments** and securing an option to acquire the company, which is developing ENA-001, an agnostic respiratory stimulant[129](index=129&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk) [Government Regulation](index=23&type=section&id=Government%20Regulation) The company operates in a highly regulated environment, with products subject to extensive FDA approval processes, post-marketing requirements, and various healthcare laws, including the Anti-Kickback Statute, False Claims Act, and the Inflation Reduction Act - The company's products are subject to extensive regulation by the FDA, governing research, development, testing, manufacturing, and marketing[138](index=138&type=chunk) - Eagle frequently uses the 505(b)(2) NDA pathway, which allows reliance on FDA's previous findings of safety and effectiveness for a reference drug, potentially reducing the need for extensive new clinical studies[160](index=160&type=chunk) - The Hatch-Waxman Act governs the approval of generic drugs (ANDAs) and 505(b)(2) applications, including provisions for patent challenges that can trigger a **30-month stay** on FDA approval[162](index=162&type=chunk) - The business is subject to numerous healthcare laws, including the federal Anti-Kickback Statute, False Claims Act, HIPAA, and the Physician Payments Sunshine Act, which regulate interactions with healthcare providers and reporting of payments[170](index=170&type=chunk)[171](index=171&type=chunk)[175](index=175&type=chunk) - Healthcare reforms, such as the Affordable Care Act (ACA) and the Inflation Reduction Act of 2022 (IRA), impact the business through mechanisms like Medicare price negotiation, inflation-based rebates, and changes to Medicaid drug rebate programs[184](index=184&type=chunk)[187](index=187&type=chunk) [Human Capital Management](index=34&type=section&id=Human%20Capital%20Management) As of December 31, 2022, Eagle Pharmaceuticals had 135 employees, including 55 direct sales representatives, with no unionized staff and good employee relations, focusing on recruiting, retaining, and incentivizing talent - As of December 31, 2022, the company had **134 employees** in the U.S. and **one** in the U.K.[194](index=194&type=chunk) - The internal commercial organization includes **55 direct sales representatives** and support staff[195](index=195&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its financial condition, regulatory approvals, commercialization, reliance on third parties, business operations, and intellectual property, alongside volatility in its common stock [Risks Related to Financial Condition and Need for Additional Capital](index=35&type=section&id=Risks%20Related%20to%20Our%20Financial%20Condition%20and%20Need%20for%20Additional%20Capital) The company's financial stability is vulnerable to macroeconomic conditions, geopolitical events, and the COVID-19 pandemic, with challenges in sustaining profitability, securing additional financing, and utilizing net operating loss carryforwards - The COVID-19 pandemic has adversely impacted and may continue to impact product sales, supply chain, clinical trials, and access to capital markets[202](index=202&type=chunk)[203](index=203&type=chunk) - The company may not be able to sustain profitability and has a history of mixed results, with net income of **$35.6 million in 2022** but a net loss of **$8.6 million in 2021**[211](index=211&type=chunk) - Failure to obtain additional financing could force the company to delay, reduce, or eliminate product development programs[215](index=215&type=chunk) - The ability to use net operating loss carryforwards and other tax attributes may be limited by ownership changes under Section 382 of the Internal Revenue Code[222](index=222&type=chunk) [Risks Related to Regulatory Approval](index=39&type=section&id=Risks%20Related%20to%20Regulatory%20Approval) The company faces substantial uncertainty in obtaining regulatory approval for product candidates, with the 505(b)(2) pathway risking patent infringement lawsuits and clinical development being a lengthy, expensive, and unpredictable process - There is no assurance of receiving regulatory approval for product candidates, which is essential for commercialization. Past setbacks include a Complete Response Letter (CRL) for Ryanodex for exertional heat stroke (EHS)[223](index=223&type=chunk) - The 505(b)(2) regulatory pathway subjects the company to the risk of patent infringement lawsuits, which can automatically delay FDA approval for up to **30 months**[247](index=247&type=chunk)[248](index=248&type=chunk) - Clinical development is inherently uncertain, and failure can occur at any stage. Results from earlier trials are not always predictive of later-stage success[230](index=230&type=chunk) - The company faces risks of being found to have improperly promoted off-label uses of its products, which can lead to significant civil, criminal, and administrative penalties[252](index=252&type=chunk) [Risks Related to Commercialization](index=47&type=section&id=Risks%20Related%20to%20Commercialization%20of%20Our%20Products%20and%20Product%20Candidates) Commercial success depends on market acceptance, faces intense competition, and is vulnerable to revenue concentration from a limited number of products, alongside challenges in securing adequate reimbursement amid increasing pricing pressures and healthcare reforms - Commercial success is critically dependent on gaining market acceptance from physicians, nurses, pharmacists, and patients[267](index=267&type=chunk) - A substantial portion of total revenue is derived from a limited number of products, with Bendeka accounting for **33% of total revenue in 2022**[273](index=273&type=chunk) - The company faces significant competition from other biotechnology and pharmaceutical companies that may have substantially greater financial and technical resources[274](index=274&type=chunk)[275](index=275&type=chunk) - Inability to achieve and maintain adequate levels of coverage and reimbursement from third-party payors could severely hinder commercial success[281](index=281&type=chunk) - Current and future healthcare legislation, such as the Inflation Reduction Act (IRA), may increase the difficulty and cost of commercialization and negatively affect product pricing[286](index=286&type=chunk)[290](index=290&type=chunk) [Risks Related to Reliance on Third Parties](index=52&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) Eagle is heavily dependent on third parties for clinical trials, manufacturing, commercial partnerships like Teva for Bendeka, and product distribution, creating risks of disruption, quality issues, and lack of direct control - The company relies on third-party CROs to conduct preclinical studies and clinical trials, and any failure by these parties to perform could delay or prevent regulatory approval[291](index=291&type=chunk) - The commercialization of Bendeka is dependent on the performance of its strategic partner, Teva, which is responsible for all U.S. commercial activities[295](index=295&type=chunk) - The company does not own manufacturing facilities and relies on third parties for all product manufacturing. Any disruption, quality issues, or failure to maintain regulatory compliance by these manufacturers could halt or delay product supply[299](index=299&type=chunk)[302](index=302&type=chunk) - The company relies on limited sources of supply for its products, and switching manufacturers would be a time-consuming and costly endeavor that could disrupt clinical trials and commercialization[308](index=308&type=chunk) [Risks Related to Business Operations and Industry](index=57&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations%20and%20Industry) The company faces operational risks including challenges in integrating acquisitions, retaining key personnel, potential product liability claims, stringent data privacy regulations, cybersecurity threats, and restrictive debt covenants - The company may fail to realize the anticipated benefits of the Acacia acquisition due to integration difficulties, diversion of management attention, and potential unknown liabilities[319](index=319&type=chunk)[320](index=320&type=chunk) - Future success is highly dependent on the ability to retain key executives, such as the CEO and CFO, and to attract and motivate qualified personnel in a competitive market[330](index=330&type=chunk) - The company is subject to stringent data privacy and security obligations (e.g., HIPAA, CCPA, GDPR), and failure to comply could lead to significant fines, litigation, and reputational harm[336](index=336&type=chunk)[338](index=338&type=chunk)[339](index=339&type=chunk) - Information technology systems are vulnerable to cyberattacks, such as ransomware, which could disrupt operations, compromise sensitive data, and result in significant financial loss[347](index=347&type=chunk)[348](index=348&type=chunk) [Risks Related to Intellectual Property](index=64&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company's competitive position depends on its ability to protect intellectual property, facing risks of patent challenges, invalidation, circumvention by competitors, and costly litigation inherent in its 505(b)(2) strategy - The company relies on a combination of patents, trade secrets, and confidentiality agreements to protect its intellectual property, but the strength of patents in the pharmaceutical field is uncertain[359](index=359&type=chunk) - The 505(b)(2) regulatory strategy requires certifying non-infringement of third-party patents, which often results in costly and time-consuming patent litigation that can delay product launches[365](index=365&type=chunk)[367](index=367&type=chunk) - Failure to comply with obligations in license agreements could result in the loss of rights to critical technology[371](index=371&type=chunk) - The patent protection for the company's products is limited to specific formulations and methods of use, as the active ingredients themselves are off-patent, which may allow competitors to design around the patents[376](index=376&type=chunk) [Risks Related to Ownership of Our Common Stock](index=69&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) The company's stock price is volatile, influenced by various factors, with principal stockholders and management exerting significant control, and future equity sales potentially causing dilution; the company does not intend to pay cash dividends - The trading price of the company's common stock has been and is likely to continue to be volatile[387](index=387&type=chunk) - Principal stockholders and management own a significant percentage of stock, allowing them to exert significant control over matters subject to stockholder approval[390](index=390&type=chunk) - The company does not intend to pay cash dividends, so any returns for stockholders will be limited to the appreciation of their stock[398](index=398&type=chunk) - Anti-takeover provisions in the company's charter and Delaware law could make it more difficult for a third party to acquire the company[400](index=400&type=chunk) [Unresolved Staff Comments](index=74&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - None[412](index=412&type=chunk) [Properties](index=74&type=section&id=Item%202.%20Properties) As of December 31, 2022, Eagle Pharmaceuticals leases all its facilities, including its corporate headquarters in Woodcliff Lake, New Jersey, and additional office and laboratory spaces - The company's corporate headquarters is located in Woodcliff Lake, New Jersey, under a lease expiring in June 2025[412](index=412&type=chunk) - Additional leased facilities include office space in Florida and Indiana, and laboratory space in Massachusetts[413](index=413&type=chunk)[414](index=414&type=chunk)[415](index=415&type=chunk) [Legal Proceedings](index=74&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in several legal proceedings, including commercial litigation with Curia Global, Inc. seeking over $80 million, multidistrict product liability litigation, and ongoing patent infringement lawsuits for its key products - Curia Global, Inc. has filed an arbitration demand and a lawsuit against the company, seeking combined damages in excess of **$80 million** for alleged breaches of supply agreements for vasopressin and PEMFEXY[727](index=727&type=chunk) - The company and its partners are actively defending patents for Bendeka and Belrapzo against multiple ANDA and 505(b)(2) filers, including Dr. Reddy's, with some cases settled and others ongoing[729](index=729&type=chunk)[735](index=735&type=chunk)[737](index=737&type=chunk) - The company received a final judgment of non-infringement in its favor in the patent litigation brought by Par Pharmaceutical regarding its vasopressin ANDA product, which was affirmed on appeal. The product was commercially launched in January 2022[743](index=743&type=chunk)[745](index=745&type=chunk) [Mine Safety Disclosures](index=74&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[418](index=418&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=75&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Eagle Pharmaceuticals' common stock trades on The Nasdaq Global Market under 'EGRX', with no cash dividends anticipated, and an active share repurchase program with approximately $86 million remaining as of December 31, 2022 - The company's common stock is listed on The Nasdaq Global Market under the symbol "EGRX"[419](index=419&type=chunk) - The company has never declared or paid a cash dividend and does not expect to in the foreseeable future[421](index=421&type=chunk) - The company has a share repurchase program, authorized in March 2020 for up to **$160.0 million**. As of December 31, 2022, approximately **$86 million** remained available for future repurchases[427](index=427&type=chunk)[430](index=430&type=chunk) - No equity securities were repurchased during the three months ended December 31, 2022[430](index=430&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=77&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In 2022, total revenue significantly increased to $316.6 million, driven by new product sales, leading to a net income of $35.6 million, a turnaround from a 2021 net loss, supported by strategic acquisitions and a new credit facility [Results of Operations](index=82&type=section&id=Results%20of%20Operations) For the year ended December 31, 2022, Eagle Pharmaceuticals reported a significant revenue increase to $316.6 million, driven by new product launches, resulting in a net income of $35.6 million, despite higher operating expenses Comparison of Years Ended Dec 31, 2022 and 2021 (in thousands) | Financial Metric | 2022 | 2021 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | **$316,610** | **$171,546** | **$145,064** | **Primarily from new product sales of PEMFEXY and vasopressin ($130.6M combined).** | | Product Sales, net | $214,536 | $65,023 | $149,513 | Launch of PEMFEXY and vasopressin. | | Royalty Revenue | $98,266 | $106,523 | ($8,257) | Lower royalties on Teva's sales of BENDEKA. | | **Total Cost of Revenue** | **$94,936** | **$42,180** | **$52,756** | **Higher cost of sales for new products ($41.2M) and amortization of acquired intangibles ($8.3M).** | | **R&D Expenses** | **$34,088** | **$51,275** | **($17,187)** | **Non-recurrence of $15M in upfront license payments made in 2021.** | | **SG&A Expenses** | **$106,626** | **$75,322** | **$31,304** | **Higher professional fees ($16.6M) from Acacia/Enalare deals and increased sales/marketing costs ($9.7M).** | | **Net Income (Loss)** | **$35,642** | **($8,627)** | **$44,269** | **Driven by strong revenue growth from new products, partially offset by higher operating expenses.** | Comparison of Years Ended Dec 31, 2021 and 2020 (in thousands) | Financial Metric | 2021 | 2020 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | **$171,546** | **$187,802** | **($16,256)** | **Lower Bendeka product sales and royalties, and non-recurrence of a $5M milestone payment from 2020.** | | Product Sales, net | $65,023 | $72,323 | ($7,300) | Decreases in Bendeka, Belrapzo, and Ryanodex sales. | | Royalty Revenue | $106,523 | $110,479 | ($3,956) | Lower royalties on Teva's sales of Bendeka. | | **R&D Expenses** | **$51,275** | **$30,785** | **$20,490** | **$15M in upfront payments for license agreements with Combioxin and AOP Orphan.** | | **Net (Loss) Income** | **($8,627)** | **$11,989** | **($20,616)** | **Result of lower revenue and significantly higher R&D expenses.** | [Liquidity and Capital Resources](index=87&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2022, the company's liquidity was $55.3 million in cash and cash equivalents, supported by $50.7 million in operating cash flow, despite significant cash usage for the Acacia acquisition and Enalare investment - Cash and cash equivalents decreased to **$55.3 million** as of December 31, 2022, from **$97.7 million** at the end of 2021[484](index=484&type=chunk) - Net cash provided by operating activities was **$50.7 million** for the year ended December 31, 2022[489](index=489&type=chunk) - Net cash used in investing activities was **$86.8 million**, primarily due to the **$74.2 million** net cash paid for the Acacia acquisition and a **$12.5 million** equity investment in Enalare[493](index=493&type=chunk) - Net cash used in financing activities was **$6.2 million**, reflecting debt proceeds of **$80 million** offset by debt repayments of **$52.2 million**, revolver repayments of **$15.0 million**, and share repurchases of **$18.0 million**[494](index=494&type=chunk) [Contractual Obligations](index=90&type=section&id=Contractual%20Obligations) As of December 31, 2022, Eagle Pharmaceuticals had total material contractual obligations of $167.0 million, primarily comprising purchase obligations for manufacturing and supply, and credit facility and term loan repayments Future Material Contractual Obligations (as of Dec 31, 2022, in thousands) | Obligation | Total | 2023 | 2024 | 2025 | Beyond | | :--- | :--- | :--- | :--- | :--- | :--- | | Operating leases | $3,207 | $1,672 | $1,122 | $413 | $— | | Credit facility and Term loans | $63,750 | $6,250 | $10,000 | $47,500 | $— | | Investment in Enalare | $12,500 | $12,500 | $— | $— | $— | | Purchase obligations | $87,501 | $87,501 | $— | $— | $— | | **Total obligations** | **$166,958** | **$107,923** | **$11,122** | **$47,913** | **$—** | [Critical Accounting Policies and Estimates](index=91&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) The company's critical accounting policies involve significant judgment and estimation, particularly in revenue recognition, where variable consideration like chargebacks and rebates must be estimated, and in business combinations, requiring fair value allocation of acquired assets and liabilities - Revenue recognition requires significant estimates for variable consideration, such as chargebacks, rebates, and returns, which are deducted from gross sales to arrive at net revenue[510](index=510&type=chunk)[513](index=513&type=chunk) - Chargebacks, which are discounts to contracted customers like GPOs, are the most significant component of the company's gross-to-net adjustments[514](index=514&type=chunk)[637](index=637&type=chunk) - Accounting for business combinations requires recording acquired assets and liabilities at their respective fair values, which involves significant management estimates, particularly for intangible assets valued using an income approach[515](index=515&type=chunk)[516](index=516&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=93&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposure is to interest rate sensitivity, affecting its cash and cash equivalents and variable-rate debt, though management believes a hypothetical 1% interest rate change would not materially impact its financial position - The company is exposed to market risk primarily from changes in U.S. interest rates[518](index=518&type=chunk) - As of December 31, 2022, the company had **$63.8 million** in variable-rate indebtedness associated with its Third Amended Credit Agreement[519](index=519&type=chunk) [Financial Statements and Supplementary Data](index=94&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section refers to Item 15 of the Annual Report on Form 10-K for the company's full consolidated financial statements and supplementary data - The company's Financial Statements and Supplementary Data are located in Item 15 of Part IV of the report[520](index=520&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=95&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) This item is not applicable to the company - Not Applicable[521](index=521&type=chunk) [Controls and Procedures](index=96&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2022, with an unqualified opinion from Ernst & Young, LLP - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2022[523](index=523&type=chunk) - Management's assessment of internal control over financial reporting excluded the business of Acacia Pharma Group plc, which was acquired on June 9, 2022[528](index=528&type=chunk) - Based on its evaluation, management concluded that the company's internal control over financial reporting was effective as of December 31, 2022[529](index=529&type=chunk) - No changes in internal control over financial reporting occurred during the fourth quarter of 2022 that have materially affected, or are reasonably likely to materially affect, internal controls[531](index=531&type=chunk) [Other Information](index=100&type=section&id=Item%209B.%20Other%20Information) The company reports that there is no other information to disclose under this item - None[543](index=543&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=100&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance will be incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information required by this item is incorporated by reference from the company's 2023 Proxy Statement[547](index=547&type=chunk) [Executive Compensation](index=100&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information required by this item is incorporated by reference from the company's 2023 Proxy Statement[549](index=549&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=100&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information concerning security ownership of certain beneficial owners, management, and related stockholder matters is incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information required by this item is incorporated by reference from the company's 2023 Proxy Statement[550](index=550&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=100&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Details regarding certain relationships, related party transactions, and the independence of the board of directors are incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information required by this item is incorporated by reference from the company's 2023 Proxy Statement[551](index=551&type=chunk) [Principal Accountant Fees and Services](index=100&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information about the fees paid to and services provided by the principal independent registered public accounting firm is incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information required by this item is incorporated by reference from the company's 2023 Proxy Statement[552](index=552&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=101&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the documents filed as part of the Form 10-K report, including consolidated financial statements and an index of all exhibits - This item contains the consolidated financial statements and a list of all exhibits filed with the report[554](index=554&type=chunk)[556](index=556&type=chunk) [Form 10-K Summary](index=104&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company indicates that there is no Form 10-K summary provided - None[561](index=561&type=chunk)

Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) Q4 2022 Earnings Conference Call March 13, 2023 8:30 AM ET Lisa Wilson - Investor Relations Brian Cahill - Chief Financial Officer Brandon Folkes - Cantor Fitzgerald David Amsellem - Piper Sandler Good morning, everyone. My name is Todd, and I'll be your conference operator. At this time, I'd like to welcome everyone to Eagle Pharmaceuticals Fourth Quarter and Full-Year 2022 Financial Results [Technical Difficulty]. All lines have been placed on mute to prevent any ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ 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 | --- | --- | --- | |----------------------------------------------------------------------------|-------------------------------------------------------------------------|------------------------ ...

Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) Q3 2022 Earnings Conference Call November 7, 2022 8:30 AM ET Company Participants Lisa Wilson - Investor Relations Scott Tarriff - President & Chief Executive Officer Brian Cahill - Chief Financial Officer Conference Call Participants Tim Lugo - William Blair Brandon Folkes - Cantor Fitzgerald David Amsellem - Piper Sandler Operator Good morning, everyone. My name is Todd and I'll be your conference operator. At this time, I'd like to welcome everyone to Eagle Pharm ...

Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) Q2 2022 Earnings Conference Call August 9, 2022 8:30 AM ET Company Participants Lisa Wilson – Investor Relations Scott Tarriff – President and Chief Executive Officer Mike Greenberg – Vice President-Medical Affairs Brian Cahill – Chief Financial Officer Conference Call Participants Lachlan Hanbury-Brown – William Blair David Amsellem – Piper Sandler Operator Good morning, everyone. My name is Katie and I will be your conference operator. At this time, I would like t ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ 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 | --- | --- | --- | --- | |----------------------------------------------------------------------------|---------------------------------------------|--------------------------------------------------- ...

Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) Q1 2022 Earnings Conference Call May 9, 2022 8:30 AM ET Company Participants Lisa Wilson - IR Scott Tarriff - Founder, President, CEO & Director Brian Cahill - CFO Conference Call Participants Brandon Folkes - Cantor Fitzgerald & Co. Lachlan Hanbury-Brown - William Blair & Company David Amsellem - Piper Sandler & Co. Operator Good morning, everyone. My name is Gretchen, and I'll be your conference operator. At this time, I'd like to welcome everyone to Eagle Pharmac ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ 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 | --- | --- | --- | --- | |----------------------------------------------------------------------------|---------------------------------------------|-------------------------------------------------- ...

Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) Q4 2021 Earnings Conference Call March 7, 2022 8:30 AM ET Company Participants Lisa Wilson - Investor Relations Scott Tarriff - Founder, Chief Executive Officer, President Brian Cahill - Chief Financial Officer Conference Call Participants Tim Lugo - William Blair Brandon Folkes - Cantor Fitzgerald David Amsellem - Piper Sandler Operator Good morning, everyone. My name is Ashley, and I'll be your conference operator. At this time, I'd like to welcome everyone to Eag ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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 001-36306 Eagle Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 2834 20-8179278 (State or Other J ...