Financial Data and Key Metrics Changes - Coherus reported net sales of UDENYCA at $110 million for Q4 2020, a decrease from $124 million in Q4 2019, primarily due to a decrease in net selling price amid increased competition [28] - For the full year 2020, UDENYCA net sales were $476 million, down from $356 million in 2019, reflecting an increase in units sold but offset by a decrease in net selling price [29][14] - R&D expenses rose to $45 million in Q4 2020 from $35 million in Q4 2019, with a full-year total of $143 million, an increase of $49 million compared to 2019 [30][31] - The company reported a net income of $10 million, or $0.12 per share, for Q4 2020, and $132 million, or $1.62 per share, for the full year 2020 [33] Business Line Data and Key Metrics Changes - UDENYCA's performance was impacted by COVID-19, which hindered market share growth against new competitors, but the company expects to regain market share as COVID recedes [8][24] - The company is advancing its biosimilar pipeline, with the FDA accepting the BLA for CHS-1420 (Humira biosimilar) for review, with an action date set for December 2021 [15] - The Lucentis biosimilar BLA is on track for submission in mid-2021, following a supportive pre-BLA meeting with the FDA [17] Market Data and Key Metrics Changes - The overall pegfilgrastim market grew 4% quarter-over-quarter in volume, while UDENYCA's market share remained stable [21] - The company anticipates significant growth opportunities in the PD-1 market, projected to be a $25 billion opportunity [20] Company Strategy and Development Direction - Coherus is expanding its late-stage pipeline to include immuno-oncology, with a collaboration announced with Junshi Biosciences for the PD-1 inhibitor toripalimab [9] - The company plans to leverage its existing infrastructure and commercial capabilities to capture a significant share of the $6 billion anti-VEGF ophthalmology market [18] - The strategy includes investing cash flows from the biosimilar business to build a robust immuno-oncology franchise [20] Management's Comments on Operating Environment and Future Outlook - Management views 2021 as a year of fundamental transition and an inflection point for the company, expecting to regain market share as COVID-19 impacts lessen [9][24] - The management expressed confidence in the upcoming BLA submissions and the potential for significant revenue growth from the expanded product portfolio [38][39] Other Important Information - The company plans to host an Analyst Day event later in the year to provide a comprehensive overview of its business and strategies [13] - Coherus has a strong balance sheet with $541 million in cash and cash equivalents at year-end [33] Q&A Session Summary Question: Context on UDENYCA sales and Q1 expectations - Management indicated that Q1 will see a dip in sales due to COVID-19 but expects recovery in Q2 as vaccination rates increase and market dynamics shift [45][49] Question: Growth share and competition with Neulasta Onpro - Management expressed confidence in regaining market share from Neulasta Onpro as COVID-19 impacts recede and emphasized the value proposition of UDENYCA [54][59] Question: Confidence in upcoming BLA submissions - Management provided assurance regarding the BLA for toripalimab, citing strong data and prior discussions with the FDA, while also expressing optimism for the Lucentis and Humira biosimilars [72][75] Question: Impact of new PD-1 entrants on the market - Management highlighted their competitive strategy focused on understanding customer needs and delivering value, indicating confidence in capturing market share despite new entrants [78][81]

PART I [Business](index=4&type=section&id=Item%201.%20Business) Coherus BioSciences is a commercial-stage biopharmaceutical company focused on biosimilars and immuno-oncology, leveraging UDENYCA® cash flows to develop a diverse pipeline [Overview and Pipeline](index=4&type=section&id=Overview%20and%20Pipeline) Coherus, a commercial biopharmaceutical firm, launched UDENYCA® in 2019 and is building an immuno-oncology franchise with toripalimab, alongside other biosimilar candidates - The company's first product, **UDENYCA® (pegfilgrastim-cbqv)**, a biosimilar to Neulasta®, was launched commercially in the United States in January 2019[13](index=13&type=chunk) - **Coherus** is investing cash flows from its biosimilars business to build an immuno-oncology franchise, initiated by in-licensing **toripalimab**, a novel anti-PD-1 antibody, from Junshi Biosciences in February 2021[14](index=14&type=chunk) Product Candidate Pipeline Summary | Category | Product/Candidate | Description | | :--- | :--- | :--- | | **Oncology** | Toripalimab | Anti-PD-1 antibody in collaboration with Junshi Biosciences. BLA submission expected in 2021 for nasopharyngeal carcinoma. | | | UDENYCA® | Pegfilgrastim-cbqv, biosimilar to Neulasta®. Additional presentations are in development. | | | Bevacizumab Biosimilar | Biosimilar to Avastin®, licensed from Innovent. | | **Immunology** | CHS-1420 | Adalimumab biosimilar candidate for Humira®. BLA submitted in Q4 2020, with a potential U.S. launch on or after July 1, 2023. | | **Ophthalmology** | Ranibizumab Biosimilar | Biosimilar to Lucentis®, licensed from Bioeq. BLA resubmission planned for 2021. | | **Small Molecule** | CHS-131 | Oral drug candidate for NASH. The company is seeking strategic alternatives for external financing. | [Market and Franchise Opportunities](index=6&type=section&id=Market%20and%20Franchise%20Opportunities) The company targets a significant market opportunity with its biosimilar and immuno-oncology candidates, addressing multi-billion dollar markets for key reference drugs 2020 U.S. Market Size for Key Reference Drugs | Reference Drug | Coherus Candidate/Product | 2020 Estimated U.S. Sales | | :--- | :--- | :--- | | Neulasta (pegfilgrastim) | UDENYCA® | $2.6 billion | | Avastin (bevacizumab) | Bevacizumab Biosimilar | $1.9 billion | | Lucentis (ranibizumab) | Ranibizumab Biosimilar | $1.5 billion | | Humira (adalimumab) | CHS-1420 | $16.0 billion | | Anti-PD-1 Antibodies | Toripalimab | $15.0 billion | - The company has deprioritized its **CHS-131 (NASH)** program, seeking strategic alternatives, and discontinued the development of **CHS-2020 (Eylea® biosimilar)** to reallocate resources to immuno-oncology[43](index=43&type=chunk)[45](index=45&type=chunk) [Operations, Manufacturing, and Competition](index=9&type=section&id=Operations%2C%20Manufacturing%2C%20and%20Competition) Coherus employs a focused commercial strategy, relies on CMOs for manufacturing, and faces significant competition across its biosimilar and immuno-oncology portfolio - The company utilizes a relatively small, highly concentrated commercial organization focused on **oncologists**, which it plans to leverage for its bevacizumab biosimilar and toripalimab if approved[47](index=47&type=chunk) - **Coherus** relies on agreements with several **contract manufacturing organizations (CMOs)** for the manufacturing and supply of its commercial and pipeline products[48](index=48&type=chunk) - **UDENYCA®** faces competition from originator **Amgen** and biosimilar developers including **Viatris**, **Mylan**, **Sandoz**, and **Pfizer**[50](index=50&type=chunk) - **Toripalimab**, if approved, will compete in a crowded U.S. market against established anti-PD-1/PD-L1 antibodies such as **Keytruda® (Merck)**, **Opdivo® (BMS)**, and **Tecentriq® (Genentech)**[51](index=51&type=chunk) [Collaboration and License Agreements](index=11&type=section&id=Collaboration%20and%20License%20Agreements) Coherus has established key strategic partnerships for toripalimab, ranibizumab, and bevacizumab biosimilars, including a Humira biosimilar settlement with AbbVie Key Collaboration and License Agreement Terms | Partner | Product/Candidate | Key Financial Terms | | :--- | :--- | :--- | | **Junshi Biosciences** | Toripalimab (anti-PD-1) | $150M upfront, 20% royalty on net sales, up to $380M in milestones. Options for two other assets. | | **Bioeq AG** | Ranibizumab (Lucentis) Biosimilar | €10M paid to date, up to €25M in future milestones, low to mid 50% profit share. | | **Innovent** | Bevacizumab (Avastin) Biosimilar | $7.5M paid to date, up to $37.5M in future milestones, mid-teens to low 20% profit share. | | **AbbVie Inc.** | CHS-1420 (Humira Biosimilar) | Global, royalty-bearing, non-exclusive license to commercialize CHS-1420, with a U.S. license period commencing July 1, 2023. | [Intellectual Property and Government Regulation](index=17&type=section&id=Intellectual%20Property%20and%20Government%20Regulation) The company's success depends on protecting its intellectual property through patents and navigating extensive government regulation, including the FDA approval process for biologics and biosimilars - The company owns a patent portfolio of **25 patent families** related to its biosimilar product candidates, covering formulations, manufacturing methods, and drug products[82](index=82&type=chunk) - The **Biologics Price Competition and Innovation Act of 2009 (BPCIA)** created an abbreviated approval pathway (**351(k)**) for biosimilars, requiring demonstration of high similarity to a reference product without clinically meaningful differences in safety, purity, and potency[107](index=107&type=chunk) - The **BPCIA** provides reference products with **12 years** of marketing exclusivity from the date of first licensure, during which the FDA cannot approve a biosimilar application[116](index=116&type=chunk) - The company is subject to numerous healthcare laws, including the federal **Anti-Kickback Statute**, **False Claims Act**, and transparency laws like the **ACA's 'sunshine' provisions**, which require reporting payments to physicians[123](index=123&type=chunk)[124](index=124&type=chunk)[125](index=125&type=chunk)[130](index=130&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including COVID-19 impacts, dependence on UDENYCA®'s commercial success, intense competition, financial needs, development uncertainties, manufacturing reliance, intellectual property litigation, and complex regulations [Risks Related to COVID-19 and Financial Condition](index=36&type=section&id=Risks%20Related%20to%20COVID-19%20and%20Financial%20Condition) The COVID-19 pandemic poses risks to sales and clinical trials, while the company faces financial challenges including a cumulative deficit of **$762.8 million** and ongoing need for future funding - The **COVID-19 pandemic** could harm business operations through decreased sales of **UDENYCA®**, delays in clinical trials, and disruptions in the third-party manufacturing supply chain[162](index=162&type=chunk) - The company has a limited history of profitability, generating net income in 2019 and 2020 but incurring net losses in all prior years, with an accumulated deficit of **$762.8 million** as of December 31, 2020[167](index=167&type=chunk)[168](index=168&type=chunk) - Future funding requirements are substantial and depend on factors like the commercial success of **UDENYCA®**, clinical study costs, and manufacturing expenses. Failure to obtain necessary capital could force delays or termination of development efforts[177](index=177&type=chunk)[179](index=179&type=chunk) [Risks Related to Commercialization and Competition](index=41&type=section&id=Risks%20Related%20to%20Commercialization%20and%20Competition) Commercial success is uncertain due to market acceptance, reimbursement pressures, and intense competition from originator products and other biosimilars, including potential life cycle extensions - Commercial success depends on market acceptance, which is influenced by factors like safety, efficacy, cost, and the ability to secure adequate third-party coverage and reimbursement[191](index=191&type=chunk)[192](index=192&type=chunk) - **UDENYCA®** and other biosimilar candidates face significant competition from reference products and other biosimilars, which could lead to price competition that detrimentally affects market share and revenue[214](index=214&type=chunk)[226](index=226&type=chunk) - Originator companies may develop improved versions of their products (life cycle extension), potentially capturing significant market share and reducing the market for **Coherus's biosimilars**[232](index=232&type=chunk)[233](index=233&type=chunk) [Risks Related to Personnel, Third-Party Reliance, and Manufacturing](index=56&type=section&id=Risks%20Related%20to%20Personnel%2C%20Third-Party%20Reliance%2C%20and%20Manufacturing) The company is highly dependent on key executives and third parties for clinical studies and manufacturing, facing risks from supplier failures and complex biologic production - The company is highly dependent on its key executives, particularly President and CEO **Dennis M. Lanfear**, and the loss of their services could harm the business[236](index=236&type=chunk)[237](index=237&type=chunk) - **Coherus** relies on third-party CROs to conduct clinical studies and is responsible for ensuring their compliance with GCP and other regulations. Failure by CROs to perform can delay or terminate development programs[241](index=241&type=chunk)[242](index=242&type=chunk) - The company depends on a single supplier, **KBI Biopharma**, for the long-term commercial manufacturing of **UDENYCA®**, and the loss of this supplier could materially harm the business[262](index=262&type=chunk)[263](index=263&type=chunk) - The manufacturing of protein-based therapeutics is inherently complex and variable. Failure to achieve the requisite degree of biosimilarity and consistency acceptable to regulators could prevent product approval[272](index=272&type=chunk) [Risks Related to Intellectual Property](index=66&type=section&id=Risks%20Related%20to%20Intellectual%20Property) Success is contingent on avoiding infringement and protecting IP, facing high risks of patent litigation from originator companies and complex BPCIA disputes - The company faces a significant risk of patent infringement claims from third parties, particularly originator companies, which could prevent or delay development and commercialization efforts[287](index=287&type=chunk) - The **BPCIA** created a complex patent dispute resolution process that could result in patent infringement litigation prior to FDA approval, potentially blocking or delaying market entry of a biosimilar product[315](index=315&type=chunk)[319](index=319&type=chunk) - On **May 2, 2019**, the company settled a trade secret lawsuit with **Amgen**. Under the settlement, **Coherus** continues to market **UDENYCA®** and began paying **Amgen** a **mid-single digit royalty** for **five years** starting **July 1, 2019**[308](index=308&type=chunk) - On **January 24, 2019**, **Coherus** and **AbbVie Inc.** entered into settlement and license agreements granting **Coherus** global, non-exclusive rights to commercialize its **Humira biosimilar (CHS-1420)**, with the U.S. license period starting **July 1, 2023**[294](index=294&type=chunk) [Risks Related to Product Development and Regulation](index=77&type=section&id=Risks%20Related%20to%20Product%20Development%20and%20Regulation) Future success depends on successful development and regulatory approval, with risks including evolving biosimilar pathways, failure to demonstrate biosimilarity, and competitive interchangeability designations - The company's future success depends on its ability to develop, obtain regulatory approval for, and commercialize its product candidates beyond **UDENYCA®**[323](index=323&type=chunk)[324](index=324&type=chunk) - The regulatory approval process is lengthy and unpredictable. A **351(k) BLA** for **Bioeq's ranibizumab biosimilar** was withdrawn after the FDA requested additional manufacturing data, with a resubmission planned[330](index=330&type=chunk)[332](index=332&type=chunk) - Failure to demonstrate biosimilarity to the satisfaction of regulatory authorities is a key risk that could prevent approval and commercialization of pipeline candidates[335](index=335&type=chunk) - If a competitor's biosimilar is determined to be "**interchangeable**" with a reference product and **Coherus's** is not, the competitor could gain market exclusivity and a significant commercial advantage[352](index=352&type=chunk)[354](index=354&type=chunk) [Unresolved Staff Comments](index=113&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) Not applicable - The company reports **no unresolved staff comments**[457](index=457&type=chunk) [Properties](index=113&type=section&id=Item%202.%20Properties) The company's headquarters are in **Redwood City, California**, and its analytical and process development laboratory in **Camarillo, California**, both leased and deemed adequate for current needs - Corporate headquarters are leased in **Redwood City, CA**, until **September 2024**[458](index=458&type=chunk) - The analytical and process development laboratory is leased in **Camarillo, CA**, until **May 2027**[458](index=458&type=chunk) [Legal Proceedings](index=113&type=section&id=Item%203.%20Legal%20Proceedings) The company has been involved in several legal proceedings, primarily with **Amgen**, settling a trade secret action and prevailing in a patent infringement case - A trade secret lawsuit with **Amgen** was settled on **May 2, 2019**. **Coherus** continues to market **UDENYCA®** and began paying a **mid-single digit royalty** to **Amgen** for **five years** starting **July 1, 2019**[460](index=460&type=chunk) - A patent infringement suit by **Amgen** regarding its '**707 patent**' was dismissed in **Coherus's** favor, and the dismissal was affirmed by the Federal Circuit in **July 2019**[461](index=461&type=chunk) [Mine Safety Disclosures](index=115&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - The company reports **no mine safety disclosures**[465](index=465&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities](index=115&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) **Coherus's** common stock trades on **The Nasdaq Global Market** under the symbol "**CHRS**"; the company has never paid cash dividends and did not repurchase equity in fiscal year 2020 - The company's common stock is listed on **The Nasdaq Global Market** under the symbol "**CHRS**"[467](index=467&type=chunk) - The company has never paid cash dividends and does not plan to in the foreseeable future. It is also precluded from doing so by the terms of its outstanding convertible notes[470](index=470&type=chunk) - **No equity securities were repurchased** during the fiscal year ended December 31, 2020[475](index=475&type=chunk) [Selected Financial Data](index=116&type=section&id=Item%206.%20Selected%20Financial%20Data) Not required - This item is **not required**[476](index=476&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=116&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In fiscal year 2020, **Coherus** reported net product revenue of **$475.8 million**, a **34%** increase from **$356.1 million** in 2019, driven by higher **UDENYCA®** sales volume, with net income of **$132.2 million** [Results of Operations](index=128&type=section&id=Results%20of%20Operations) For FY2020, net product revenue increased to **$475.8 million** from higher **UDENYCA®** sales, resulting in **$132.2 million** net income despite increased R&D expenses of **$142.8 million** Comparison of Key Financial Metrics (2020 vs. 2019) | Metric | FY 2020 (in millions) | FY 2019 (in millions) | Change (in millions) | | :--- | :--- | :--- | :--- | | Net Product Revenue | $475.8 | $356.1 | $119.7 | | Cost of Goods Sold | $37.7 | $17.1 | $20.6 | | Gross Margin | 92% | 95% | -3% | | R&D Expense | $142.8 | $94.2 | $48.6 | | SG&A Expense | $139.1 | $137.0 | $2.1 | | Net Income | $132.2 | $89.8 | $42.4 | - The increase in R&D expense in 2020 was primarily due to a **$16.0 million** increase in costs for **CHS-1420 BLA** submission activities and a **$14.2 million** increase for **CHS-2020** manufacturing scale-up[549](index=549&type=chunk) - A portion of the manufacturing costs for **UDENYCA®** sold in 2020 and 2019 was expensed as R&D prior to approval, which favorably impacted the gross margin. The company expects to utilize this **zero-cost inventory** by **Q1 2021**[546](index=546&type=chunk) [Liquidity and Capital Resources](index=133&type=section&id=Liquidity%20and%20Capital%20Resources) As of **December 31, 2020**, the company had **$541.2 million** in cash, with **$154.1 million** from operations and **$223.9 million** from financing, including **$230.0 million** in new convertible notes Cash Flow Summary (in millions) | Cash Flow Activity | FY 2020 | FY 2019 | FY 2018 | | :--- | :--- | :--- | :--- | | Net cash from operating activities | $154.1 | $28.4 | $(159.3) | | Net cash used in investing activities | $(14.4) | $(12.7) | $(1.2) | | Net cash from financing activities | $223.9 | $89.4 | $105.4 | - The company ended 2020 with **$541.2 million** in cash and cash equivalents, compared to **$177.7 million** at the end of 2019[576](index=576&type=chunk)[622](index=622&type=chunk) - In **April 2020**, the company issued **$230.0 million** of **1.5% convertible senior subordinated notes due 2026**, with net proceeds of **$222.2 million**[515](index=515&type=chunk)[590](index=590&type=chunk) - Management believes current cash and cash from **UDENYCA®** sales will be sufficient to fund planned expenditures for at least the **next 12 months**[576](index=576&type=chunk) [Critical Accounting Policies and Estimates](index=124&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Critical accounting policies involve significant judgment for revenue recognition, inventory valuation, and income taxes, including a **full valuation allowance** against deferred tax assets of **$200.9 million** - Net product revenue is recorded at a transaction price that includes estimates of variable consideration for chargebacks, rebates, co-pay assistance, and returns. These reserves are based on historical data, contracts, and market trends[526](index=526&type=chunk) - Inventory costs for **UDENYCA®** began to be capitalized upon FDA approval in **November 2018**. Costs incurred before this date were expensed as R&D[533](index=533&type=chunk)[535](index=535&type=chunk) - The company maintains a **full valuation allowance** against its net deferred tax assets (**$200.9 million** as of **Dec 31, 2020**) due to its history of operating losses, meaning it is not currently recognizing these assets on its balance sheet[538](index=538&type=chunk)[539](index=539&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=143&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to interest rate risk on cash equivalents and foreign currency exchange risk from international contracts, but does not currently use derivative instruments to hedge these - The company's primary market risks are interest rate risk on its cash equivalents and foreign currency exchange risk from international contracts[602](index=602&type=chunk)[603](index=603&type=chunk) - Exposure to interest rate risk is considered **not significant** due to the short-term duration of cash equivalent investments[602](index=602&type=chunk) - Foreign exchange risk exists due to transactions with global CROs and manufacturers. The company does not currently use forward exchange contracts to hedge this exposure[603](index=603&type=chunk) [Financial Statements and Supplementary Data](index=144&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section includes the company's audited consolidated financial statements and the independent auditor's **unqualified opinion** on financial statements and internal controls [Report of Independent Registered Public Accounting Firm](index=145&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) **Ernst & Young LLP** issued an **unqualified opinion** on **Coherus BioSciences'** financial statements and internal controls, identifying chargeback and rebate estimates as a **critical audit matter** - The independent auditor, **Ernst & Young LLP**, issued an **unqualified (clean) opinion** on the company's consolidated financial statements[610](index=610&type=chunk) - The auditor also issued an **unqualified opinion** on the effectiveness of the company's internal control over financial reporting as of **December 31, 2020**[611](index=611&type=chunk) - The audit identified the '**Estimate of Reserves for Chargebacks and Rebates**' as a **critical audit matter** due to the significant judgment required for assumptions like channel and payer mix[617](index=617&type=chunk) [Consolidated Financial Statements](index=147&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements show significant growth in 2020, with total assets reaching **$841.6 million** and net income of **$132.2 million**, reflecting a strengthened financial position Key Balance Sheet Data (as of Dec 31, in thousands) | Account | 2020 | 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $541,158 | $177,668 | | Total current assets | $767,479 | $343,009 | | Total assets | $841,649 | $408,927 | | Total current liabilities | $145,653 | $114,969 | | Total liabilities | $560,675 | $303,713 | | Total stockholders' equity | $280,974 | $105,214 | Key Statement of Operations Data (Year ended Dec 31, in thousands) | Account | 2020 | 2019 | 2018 | | :--- | :--- | :--- | :--- | | Net product revenue | $475,824 | $356,071 | $0 | | Total operating expenses | $319,505 | $248,303 | $204,416 | | Income (loss) from operations | $156,319 | $107,768 | $(204,416) | | Net income (loss) | $132,244 | $89,833 | $(209,409) | | Diluted EPS | $1.62 | $1.23 | $(3.22) | [Notes to Consolidated Financial Statements](index=153&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail accounting policies, revenue recognition, licensing agreements, debt obligations including **2026** and **2022 convertible notes**, stock-based compensation, and income tax positions - **Revenue** from **UDENYCA®** is recognized upon delivery to the customer, net of estimated variable consideration for chargebacks, rebates, and other discounts[673](index=673&type=chunk)[674](index=674&type=chunk) - The company's three largest customers, **McKesson**, **AmeriSource-Bergen**, and **Cardinal**, accounted for **38%**, **37%**, and **23%** of total revenue in 2020, respectively[737](index=737&type=chunk) - As of **December 31, 2020**, the company had total debt obligations with a net carrying amount of **$404.0 million**, consisting of the **2026 Convertible Notes ($223.0M)**, **2022 Convertible Notes ($106.5M)**, and the **Term Loan ($74.5M)**[756](index=756&type=chunk)[771](index=771&type=chunk)[784](index=784&type=chunk) - Total unrecognized stock-based compensation expense as of **December 31, 2020**, was **$81.1 million** (**$68.5 million** for stock options and **$12.6 million** for RSUs), expected to be recognized over a weighted-average period of approximately **2.6** and **1.8 years**, respectively[811](index=811&type=chunk)[816](index=816&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=198&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) None - The company reports **no changes in or disagreements** with its accountants on accounting and financial disclosure[848](index=848&type=chunk) [Controls and Procedures](index=198&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were **effective** as of **December 31, 2020**, with no material changes during the **fourth quarter of 2020** - Management concluded that the company's disclosure controls and procedures were **effective** as of **December 31, 2020**[849](index=849&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective** as of **December 31, 2020**, based on the **COSO 2013 framework**[852](index=852&type=chunk) - **No changes** in internal control over financial reporting occurred during the **fourth quarter of 2020** that have materially affected, or are reasonably likely to materially affect, these controls[864](index=864&type=chunk) [Other Information](index=201&type=section&id=Item%209B.%20Other%20Information) Not applicable - The company reports **no other information**[865](index=865&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=202&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the forthcoming **2021 Proxy Statement** - Information regarding directors, executive officers, and corporate governance is incorporated by reference from the forthcoming **2021 Proxy Statement**[869](index=869&type=chunk) [Executive Compensation](index=202&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the forthcoming **2021 Proxy Statement** - Information regarding executive compensation is incorporated by reference from the forthcoming **2021 Proxy Statement**[870](index=870&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=202&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership is incorporated by reference from the forthcoming **2021 Proxy Statement** - Information regarding security ownership is incorporated by reference from the forthcoming **2021 Proxy Statement**[870](index=870&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=202&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding related transactions and director independence is incorporated by reference from the forthcoming **2021 Proxy Statement** - Information regarding related transactions and director independence is incorporated by reference from the forthcoming **2021 Proxy Statement**[871](index=871&type=chunk) [Principal Accounting Fees and Services](index=202&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services is incorporated by reference from the forthcoming **2021 Proxy Statement** - Information regarding principal accounting fees and services is incorporated by reference from the forthcoming **2021 Proxy Statement**[872](index=872&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=203&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists financial statements filed under **Item 8** and all exhibits, including corporate governance documents, material contracts, and certifications - The financial statements required by this item are filed in **Item 8** of the report[874](index=874&type=chunk) - An index of all exhibits filed with the report is provided, including material contracts and certifications[875](index=875&type=chunk)[878](index=878&type=chunk) [Form 10-K Summary](index=203&type=section&id=Item%2016.%20Form%2010-K%20Summary) **No Form 10-K summary is provided** - **No Form 10-K summary is provided**[876](index=876&type=chunk)

UDENYCA® Performance - UDENYCA® has generated over $720 million in revenues since its launch in 2019[6] - UDENYCA® holds over 20% share of the overall pegfilgrastim market[6] - The U S healthcare system has saved approximately $2 billion since UDENYCA® launch[6] - There is an opportunity to capture approximately 70% market share of Neulasta Onpro and Neulasta pre-filled syringe[8] Biosimilar Portfolio - The late-stage biosimilar pipeline increases the potential addressable market to approximately $29 billion[8, 9] - Humira® is expected to reach over $17 billion in annual sales before biosimilar entry in 2023[13] - Coherus submitted a 351(k) BLA for its internally developed Humira® biosimilar, CHS-1420, at the end of 2020[16] - The BLA filing for Avastin® biosimilar is projected for the second half of 2021[19] Core Capabilities and Financial Strength - Coherus reported $365 million in UDENYCA® net product revenue for the nine months ended September 30, 2020[40] - Coherus had $503 million in cash and investments[40]

Coherus BioSciences, Inc. (NASDAQ:CHRS) Q3 2020 Earnings Conference Call November 5, 2020 4:30 PM ET Company Participants McDavid Stilwell - EVP of Corporate Development; IR and Financial Strategy Denny Lanfear - CEO Jean Viret - CFO Chris Thompson - EVP,Sales Dinesh Purandare - EVP, Commercial Strategy & Operations Conference Call Participants Mohit Bansal - Citi Group Balaji Prasad - Barclays Jason Gerberry - Bank of America Greg Gilbert - Truist Securities Douglas Tsao - H.C. Wainwright Chris Schott - JP ...

[CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS](index=4&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD%20LOOKING%20STATEMENTS) This section warns that forward-looking statements involve substantial risks and uncertainties, advising against undue reliance as actual results may differ materially - Forward-looking statements involve substantial risks and uncertainties concerning business, operations, and financial performance[10](index=10&type=chunk) - Key areas of uncertainty include **UDENYCA® sales**, biosimilar candidate development (bevacizumab, adalimumab, ranibizumab, aflibercept), regulatory approvals, market size, financial performance, and **COVID-19 impact**[10](index=10&type=chunk)[12](index=12&type=chunk) - Actual results may differ materially from current expectations due to factors discussed under Part II, Item 1A. Risk Factors[13](index=13&type=chunk) PART I. FINANCIAL INFORMATION [ITEM 1. Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=ITEM%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section presents Coherus BioSciences' unaudited condensed consolidated financial statements, prepared under U.S. GAAP, detailing financial position and performance [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) These balance sheets present the company's financial position, detailing assets, liabilities, and stockholders' equity as of September 30, 2020, and December 31, 2019 | Metric | Sep 30, 2020 (unaudited) | Dec 31, 2019 | | :----- | :----------------------- | :----------- | | **Assets** | | | | Cash and cash equivalents | $292,465 | $177,668 | | Investments in marketable securities | $210,966 | $0 | | Total current assets | $726,920 | $343,009 | | Total assets | $803,733 | $408,927 | | **Liabilities** | | | | Total current liabilities | $133,432 | $114,969 | | Convertible notes due 2026 | $222,718 | $0 | | Total liabilities | $548,002 | $303,713 | | **Stockholders' Equity** | | | | Total stockholders' equity | $255,731 | $105,214 | | Accumulated deficit | $(772,462) | $(894,998) | - Total assets increased significantly from **$408.9 million** at December 31, 2019, to **$803.7 million** at September 30, 2020[16](index=16&type=chunk) - Total liabilities also increased substantially from **$303.7 million** to **$548.0 million**, primarily due to the issuance of Convertible Notes due 2026[16](index=16&type=chunk) [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) These statements present the company's financial performance for the three and nine months ended September 30, 2020, and 2019, detailing revenue, operating expenses, and net income | Metric | Three Months Ended Sep 30, 2020 | Three Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :----- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Net product revenue | $113,551 | $111,684 | $365,405 | $232,215 | | Cost of goods sold | $9,000 | $6,447 | $25,994 | $9,273 | | Research and development | $38,851 | $21,568 | $98,131 | $59,240 | | Selling, general and administrative | $31,984 | $31,828 | $101,386 | $100,967 | | Income from operations | $33,716 | $51,841 | $139,894 | $62,735 | | Net income | $27,933 | $47,043 | $122,536 | $50,606 | | Basic EPS | $0.39 | $0.67 | $1.72 | $0.73 | | Diluted EPS | $0.33 | $0.63 | $1.52 | $0.69 | - Net product revenue increased by **$1.9 million (1.7%)** for the three months and by **$133.2 million (57.4%)** for the nine months ended September 30, 2020, compared to the respective prior periods[22](index=22&type=chunk) - Research and development expenses increased significantly by **$17.3 million (80.1%)** for the three months and **$38.9 million (65.7%)** for the nine months ended September 30, 2020, reflecting increased pipeline activities[22](index=22&type=chunk) - Net income for the three months ended September 30, 2020, decreased to **$27.9 million** from **$47.0 million** in 2019, while for the nine months, it increased to **$122.5 million** from **$50.6 million**[21](index=21&type=chunk) [Condensed Consolidated Statements of Comprehensive Income](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income) This statement details comprehensive income components, including net income and other comprehensive income (loss) items like unrealized gains on available-for-sale securities | Metric | Three Months Ended Sep 30, 2020 | Three Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :----- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Net income | $27,933 | $47,043 | $122,536 | $50,606 | | Unrealized gain on available-for-sale securities, net of tax | $6 | $0 | $18 | $0 | | Foreign currency translation adjustments, net of tax | $(4) | $59 | $285 | $(170) | | Comprehensive income | $27,935 | $47,102 | $122,839 | $50,436 | - Comprehensive income for the nine months ended September 30, 2020, was **$122.8 million**, a significant increase from **$50.4 million** in the prior year, primarily driven by higher net income[24](index=24&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) These statements track changes in stockholders' equity over the three and nine months ended September 30, 2020, and 2019, including common stock issuances and net income | Date | Total Stockholders' Equity | | :--- | :------------------------- | | Dec 31, 2019 | $105,214 | | Sep 30, 2020 | $255,731 | - Total stockholders' equity increased from **$105.2 million** at December 31, 2019, to **$255.7 million** at September 30, 2020, largely due to net income and additional paid-in capital[28](index=28&type=chunk) - Accumulated deficit decreased from **$(894.9) million** to **$(772.4) million**, reflecting the company's profitability during the period[28](index=28&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement provides a breakdown of cash flows from operating, investing, and financing activities for the nine months ended September 30, 2020, and 2019 | Metric | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :----- | :----------------------------- | :----------------------------- | | Net cash provided by operating activities | $121,021 | $10,645 | | Net cash used in investing activities | $(224,457) | $(6,670) | | Net cash provided by financing activities | $218,433 | $88,170 | | Net increase in cash, cash equivalents and restricted cash | $114,997 | $91,975 | | Cash, cash equivalents and restricted cash at end of period | $292,905 | $165,166 | - Net cash provided by operating activities significantly increased to **$121.0 million** for the nine months ended September 30, 2020, from **$10.6 million** in the prior year[37](index=37&type=chunk) - Investing activities show a substantial increase in cash used, primarily due to purchases of marketable securities (**$273.8 million**) and license fee payments (**$7.5 million**)[37](index=37&type=chunk) - Financing activities provided **$218.4 million**, largely driven by proceeds from the issuance of 2026 Convertible Notes (**$222.2 million**)[37](index=37&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations and disclosures for the figures presented in the condensed consolidated financial statements, covering

Coherus BioSciences, Inc. (NASDAQ:CHRS) Q2 2020 Earnings Conference Call August 6, 2020 4:30 PM ET Company Participants David Arrington – Vice President-Investor Relations and Corporate Affairs Denny Lanfear – Chief Executive Officer Jean Viret – Chief Financial Officer Chris Thompson – Executive Vice President-Sales Conference Call Participants Mike Ulz – Baird Ken Cacciatore – Cowan & Company Mohit Bansal – Citigroup Jason Gerberry – Bank of America Chris Schott – JPMorgan Greg Gilbert – Truist Securities ...

Table of Contents 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, 2020 ☐ 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: 001-36721 | --- | --- | --- | |----------------------------------------------------------------------------------------------|-- ...

Coherus BioSciences, Inc. (NASDAQ:CHRS) Q1 2020 Results Earnings Conference Call May 7, 2020 4:30 PM ET Company Participants David Arrington - VP of IR & Corporate Affairs Dennis Lanfear - Chairman, President & CEO Jean Viret - CFO Chris Thompson - EVP, Market Access Conference Call Participants Stacy Ku - Cowen and Company Mike Ulz - Baird Mohit Bansal - Citigroup. Douglas Tsao - H.C. Wainwright Chris Schott - JPMorgan Operator Ladies and gentlemen, thank you for standing by. And welcome to the Coherus Bio ...

Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered 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, 2020 ☐ 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: 001-36721 Coherus BioSciences, Inc. (Exact name ...

Coherus BioSciences, Inc. (NASDAQ:CHRS) Q4 2019 Earnings Conference Call February 27, 2020 4:30 PM ET Company Participants David Arrington - Vice President of Investor Relations & Corporate Affairs Dennis Lanfear - Chief Executive Officer Jean Viret - Chief Financial Officer Vince Anicett - Chief Operating Officer Thomas Fitzpatrick - Chief Legal Officer Conference Call Participants Mohit Bansal - Citigroup Douglas Tsao - H.C. Wainwright Mike Wolff - Baird Ekaterina Knyazkova - JP Morgan Chase & Co Salim Sy ...