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☒
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
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☐
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TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
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Delaware
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94-3134940
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(State or other jurisdiction of
incorporation or organization)
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(IRS Employer
Identification No.)
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Title of Each Class
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Trading Symbol
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Name of Each Exchange on Which Registered
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Common Stock, $0.0001 par value
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NKTR
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NASDAQ Global Select Market
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Large Accelerated Filer
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☒
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Accelerated filer
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☐
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Non-accelerated filer
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☐
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Smaller reporting company
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☐
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Emerging growth company
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☐
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Page
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•
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improve efficacy or safety of a drug as a result of better pharmacokinetics, pharmacodynamics, longer half-life and sustained exposure of the drug;
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improve targeting or binding affinity of a drug to its target receptors with the potential to improve efficacy and reduce toxicity or drug resistance;
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improve solubility of a drug;
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enable oral administration of parenterally-administered drugs, or drugs that must be administered intravenously or subcutaneously, and increase oral bioavailability of small molecules;
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prevent drugs from crossing the blood-brain barrier, or reduce their rate of passage into the brain, thereby limiting undesirable central nervous system effects;
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reduce first-pass metabolism effects of certain drug classes with the potential to improve efficacy, which could reduce the need for other medicines and reduce toxicity;
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reduce the rates of drug absorption and of elimination or metabolism by improving stability of the drug in the body and providing it with more time to act on its target;
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differentially alter binding affinity of a drug for multiple receptors, improving its selectivity for one receptor over another; and
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reduce immune response to certain macromolecules with the potential to prolong their effectiveness with repeated doses.
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Drug Candidate
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Target Indication
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Status(1)
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Bempegaldesleukin (CD122-preferential IL-2 pathway agonist)
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Immuno-oncology
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Phase 1, Phase 2, and Phase 3 studies ongoing in multiple indications
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NKTR-358 (cytokine Treg stimulant)
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Autoimmune Disease
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Phase 1
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NKTR-262 (toll-like receptor agonist)
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Oncology
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Phase 1
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NKTR-255 (IL-15 receptor agonist)
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Immuno-oncology
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Phase 1
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(1)
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Status definitions are:
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•
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On November 6, 2018, we entered into a clinical collaboration with Pfizer to evaluate several combination regimens in multiple cancer settings, including metastatic castration-resistant prostate cancer and squamous cell carcinoma of the head and neck. The combination regimens in this collaboration will evaluate bempegaldesleukin with avelumab, a human anti-PD-L1 antibody in development by Merck KGaA and Pfizer; talazoparib, a poly (ADP-ribose) polymerase (PARP) inhibitor developed by Pfizer; or enzalutamide, an androgen receptor inhibitor in development by Pfizer and Astellas Pharma Inc.
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•
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A Phase 1 study in pancreatic cancer patients in collaboration with BioXcel is planned to evaluate a triplet combination of bempegaldesleukin, BXCL-701 (a small molecule immune-modulator, DPP 8/9), and avelumab (being supplied to BioXcel by Pfizer and Merck KGaA).
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•
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We are also working in collaboration with Vaccibody AS to evaluate bempegaldesleukin with Vaccibody’s personalized cancer neoantigen vaccine in a Phase 1 proof-of-concept study.
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Drug
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Primary or Target
Indications
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Drug
Marketer/Partner
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Status(1)
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NKTR-358
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Autoimmune disease
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Eli Lilly and Company
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Phase 1
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ADYNOVATE® (previously referred to as BAX 855, PEGylated rFVIII) and ADYNOVI® (brand name for ADYNOVATE® in Europe)
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Hemophilia A
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Takeda Pharmaceutical Company Limited
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Approved 2015
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MOVANTIK® (naloxegol tablets) and MOVENTIG® (brand name for MOVANTIK® in Europe)
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Opioid-induced constipation in adult patients with chronic non-cancer pain (US); Opiod-induced constipation in adult patients who have and inadequate response to laxatives (EU).
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AstraZeneca AB
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Approved 2014
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CIMZIA® (certolizumab pegol)
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Crohn’s disease, Rheumatoid arthritis, and Psoriasis/ Ankylosing Spondylitis
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UCB Pharma
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Approved 2008*
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MIRCERA® (C.E.R.A.) (Continuous Erythropoietin Receptor Activator)
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Anemia associated with chronic kidney disease in patients on dialysis and patients not on dialysis
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F. Hoffmann-La Roche Ltd
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Approved 2007*
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Macugen® (pegaptanib sodium injection)
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Age-related macular degeneration
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Bausch Health Companies Inc. (formerly, Valeant Pharmaceuticals International, Inc.)
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Approved 2004
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Somavert® (pegvisomant)
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Acromegaly
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Pfizer Inc.
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Approved 2003
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Neulasta® (pegfilgrastim)
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Neutropenia
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Amgen Inc.
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Approved 2002
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Dapirolizumab Pegol
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Systemic Lupus Erythematosus
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UCB Pharma (Biogen)
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Phase 2
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PEGPH20
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Pancreatic, Non-Small Cell Lung Cancer, and other multiple tumor types
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Halozyme Therapeutics, Inc.
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Further development halted.
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Longer-acting blood clotting proteins
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Hemophilia
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Takeda
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Research/Preclinical
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(1)
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Status definitions are:
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*
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In February 2012, we sold our rights to receive royalties on future worldwide net sales of CIMZIA® and MIRCERA® effective as of January 1, 2012.
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•
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extensive preclinical laboratory and animal testing;
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•
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submission of an Investigational New Drug (IND) prior to commencing clinical trials;
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•
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adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug for the intended indication;
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•
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extensive pharmaceutical development for the characterization of the chemistry, manufacturing process and controls for the active ingredient and drug product; and
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submission to the FDA of an NDA for approval of a drug or a Biological License Application (BLA) for approval of a biological product.
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•
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determine the preliminary efficacy of the product for specific targeted indications;
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•
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determine dosage and regimen of administration; and
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•
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identify possible adverse effects and safety risks.
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•
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the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering, or paying remuneration (a term interpreted broadly to include anything of value, including, for example, gifts, discounts, and credits), directly or indirectly, in cash or in kind, to induce or
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•
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federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment to Medicare, Medicaid, or other third-party payers that are false or fraudulent, or making a false statement or record material to payment of a false claim or avoiding, decreasing, or concealing an obligation to pay money owed to the federal government;
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•
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provisions of the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes, referred to as the “HIPAA All-payer Fraud Prohibition,” that prohibit knowingly and willfully executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters;
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•
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federal transparency laws, including the federal Physician Payment Sunshine Act, which require manufacturers of certain drugs and biologics to track and disclose payments and other transfers of value they make to U.S. physicians (currently defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals as well as physician ownership and investment interests in the manufacturer, and that such information is subsequently made publicly available in a searchable format on a CMS website, effective January 1, 2022, these reporting obligations will extend to include transfers of value made to certain non-physician providers such as physician assistants and nurse practitioners;
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•
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provisions of HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; and
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•
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state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, state transparency reporting and compliance laws; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and which may not have the same effect, thus complicating compliance efforts.
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Year Ended December 31,
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2019
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2018
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2017
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||||||
Third party and direct materials costs
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$
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221.5
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$
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206.9
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$
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125.4
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Personnel, overhead and other costs
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141.7
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130.8
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113.5
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Stock-based compensation and depreciation
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71.4
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61.8
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29.6
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Research and development expense
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$
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434.6
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$
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399.5
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$
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268.5
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Name
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Age
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Position
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Howard W. Robin
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67
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Director, President and Chief Executive Officer
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Gil M. Labrucherie, J.D.
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48
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Chief Operating Officer and Chief Financial Officer
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John Northcott
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42
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Senior Vice President and Chief Commercial Officer
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Jillian B. Thomsen
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54
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Senior Vice President, Finance and Chief Accounting Officer
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Jonathan Zalevsky, Ph.D.
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45
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Chief Research and Development Officer
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•
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delays in obtaining regulatory authorization to commence a clinical study;
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•
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delays in reaching agreement with applicable regulatory authorities on a clinical study design;
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•
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for product candidates (such as bempegaldesleukin and NKTR-358) partnered with other companies, delays caused by our partner;
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•
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imposition of a clinical hold by the FDA or other health authorities, which may occur at any time including after any inspection of clinical trial operations or trial sites;
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•
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suspension or termination of a clinical study by us, our partners, the FDA or foreign regulatory authorities due to adverse side effects of a drug on subjects in the trial;
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•
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delays in recruiting suitable patients to participate in a trial;
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•
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delays in having patients complete participation in a trial or return for post-treatment follow-up;
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•
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clinical sites dropping out of a trial to the detriment of enrollment rates;
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•
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delays in manufacturing and delivery of sufficient supply of clinical trial materials;
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•
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changes in regulatory authorities policies or guidance applicable to our drug candidates; and
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•
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delays caused by changing standards of care or new treatment options.
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•
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designing and conducting large scale clinical studies;
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•
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preparing and filing documents necessary to obtain government approvals to sell a given drug candidate; and/
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•
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marketing and selling the drugs when and if they are approved.
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•
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we have very little control over the timing and level of resources that our collaboration partners dedicate to commercial marketing efforts such as the amount of investment in sales and marketing personnel, general marketing campaigns, direct-to-consumer advertising, product sampling, pricing agreements and rebate strategies with government and private payers, manufacturing and supply of drug product, and other marketing
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•
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collaboration partners with commercial rights may choose to devote fewer resources to the marketing of our partnered drugs than they devote to their own drugs or other drugs that they have in-licensed;
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•
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we have very little control over the timing and amount of resources our partners devote to development programs in one or more major markets;
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•
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disagreements with partners could lead to delays in, or termination of, the research, development or commercialization of product candidates or to litigation or arbitration proceedings;
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•
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disputes may arise or escalate in the future with respect to the ownership of rights to technology or intellectual property developed with partners;
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•
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we do not have the ability to unilaterally terminate agreements (or partners may have extension or renewal rights) that we believe are not on commercially reasonable terms or consistent with our current business strategy;
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•
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partners may be unable to pay us as expected; and
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•
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partners may terminate their agreements with us unilaterally for any or no reason, in some cases with the payment of a termination fee penalty and in other cases with no termination fee penalty.
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•
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the cost, timing and outcomes of clinical studies and regulatory reviews of our drug candidates —important examples include bempegaldesleukin and NKTR-358;
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•
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the commercial launch and sales levels of products marketed by our collaboration partners for which we are entitled to royalties and sales milestone payments—importantly, the level of success in marketing and selling MOVANTIK® by AstraZeneca in the U.S. and ADYNOVATE® by Baxalta (a wholly-owned subsidiary of Takeda) globally, as well as MOVENTIG® (the naloxegol brand name in the EU) by Kirin in the EU;
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•
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if and when we receive potential milestone payments and royalties from our existing collaborations if the drug candidates subject to those collaborations achieve clinical, regulatory or commercial success;
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•
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the progress, timing, cost and results of our clinical development programs;
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•
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the success, progress, timing and costs of our efforts to implement new collaborations, licenses and other transactions that increase our current net cash, such as the sale of additional royalty interests held by us, term loan or other debt arrangements, and the issuance of securities;
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•
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the number of patients, enrollment criteria, primary and secondary endpoints, and the number of clinical studies required by the regulatory authorities in order to consider for approval our drug candidates and those of our collaboration partners;
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•
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our general and administrative expenses, capital expenditures and other uses of cash; and
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•
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disputes concerning patents, proprietary rights, or license and collaboration agreements that negatively impact our receipt of milestone payments or royalties or require us to make significant payments arising from licenses, settlements, adverse judgments or ongoing royalties.
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•
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clinical development and commercialization obligations that are based on certain commercial reasonableness performance standards that can often be difficult to enforce if disputes arise as to adequacy of our partner’s performance;
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•
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research and development performance and reimbursement obligations for our personnel and other resources allocated to partnered drug candidate development programs;
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•
|
clinical and commercial manufacturing agreements, some of which are priced on an actual cost basis for products supplied by us to our partners with complicated cost allocation formulas and methodologies;
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•
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intellectual property ownership allocation between us and our partners for improvements and new inventions developed during the course of the collaboration;
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•
|
royalties on drug sales based on a number of complex variables, including net sales calculations, geography, scope of patent claim coverage, patent life, generic competitors, bundled pricing and other factors; and
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•
|
indemnity obligations for intellectual property infringement, product liability and certain other claims.
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•
|
our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
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•
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the inability of sales personnel to obtain access to or successfully educate adequate numbers of physicians about the potential benefits associated with the use of, and to subsequently prescribe, our products;
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•
|
the lack of complementary products or multiple product pricing arrangements may put us at a competitive disadvantage relative to companies with more extensive product lines; and
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•
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unforeseen costs and expenses associated with creating and sustaining an independent sales and marketing organization.
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•
|
develop drugs utilizing our technologies, either independently or in collaboration with other pharmaceutical or biotechnology companies;
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•
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effectively estimate and manage clinical development costs, particularly the cost of the clinical studies for bempegaldesleukin, NKTR-358, NKTR-262, and NKTR-255;
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•
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receive necessary regulatory and marketing approvals;
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•
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maintain or expand manufacturing at necessary levels;
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•
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achieve market acceptance of our partnered products;
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•
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receive royalties on products that have been approved, marketed or submitted for marketing approval with regulatory authorities; and
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•
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maintain sufficient funds to finance our activities.
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•
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announcements of data from, or material developments in, our clinical studies and those of our collaboration partners, including data regarding efficacy and safety, delays in clinical development, regulatory approval or commercial launch – in particular, data from clinical studies of bempegaldesleukin has had a significant impact on our stock price;
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•
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announcements by collaboration partners as to their plans or expectations related to drug candidates and approved drugs in which we have a substantial economic interest;
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•
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announcements regarding terminations or disputes under our collaboration agreements;
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•
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fluctuations in our results of operations;
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•
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developments in patent or other proprietary rights, including intellectual property litigation or entering into intellectual property license agreements and the costs associated with those arrangements;
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•
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announcements of technological innovations or new therapeutic products that may compete with our approved products or products under development;
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•
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announcements of changes in governmental regulation affecting us or our competitors;
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•
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litigation brought against us or third parties to whom we have indemnification obligations;
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•
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public concern as to the safety of drug formulations developed by us or others;
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•
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our financing needs and activities; and
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•
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general market conditions.
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•
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establishment of a classified board of directors such that not all members of the board may be elected at one time;
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•
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lack of a provision for cumulative voting in the election of directors, which would otherwise allow less than a majority of stockholders to elect director candidates;
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•
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the ability of our board to authorize the issuance of “blank check” preferred stock to increase the number of outstanding shares and thwart a takeover attempt;
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•
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prohibition on stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of stockholders;
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•
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establishment of advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon by stockholders at stockholder meetings; and
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•
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limitations on who may call a special meeting of stockholders.
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•
|
incur or guarantee additional indebtedness or issue disqualified capital stock or cause certain of our subsidiaries to issue preferred stock;
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•
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pay dividends or distributions, redeem equity interests or subordinated indebtedness or make certain types of investments;
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•
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create or incur liens;
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•
|
transfer, sell, lease or otherwise dispose of assets and issue or sell equity interests in certain of our subsidiaries;
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•
|
incur restrictions on certain of our subsidiaries’ ability to pay dividends or other distributions to the Company or to make intercompany loans, advances or asset transfers;
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•
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enter into transactions with affiliates;
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•
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engage in any business other than businesses which are the same, similar, ancillary or reasonably related to our business as of the date of the indenture; and
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•
|
consummate a merger, consolidation, reorganization or business combination, sell, lease, convey or otherwise dispose of all or substantially all of our assets or other change of control transaction.
|
•
|
the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering, or paying remuneration (a term interpreted broadly to include anything of value, including, for example, gifts, discounts, and credits), directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order, or recommendation of, an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs;
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•
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federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment to Medicare, Medicaid, or other third-party payers that are false or fraudulent, or making a false statement or record material to payment of a false claim or avoiding, decreasing, or concealing an obligation to pay money owed to the federal government;
|
•
|
provisions of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), which created new federal criminal statutes, referred to as the “HIPAA All-Payer Fraud Prohibition,” that prohibit knowingly and willfully executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters;
|
•
|
federal transparency laws, including the federal Physician Payment Sunshine Act, which require manufacturers of certain drugs and biologics to track and disclose payments and other transfers of value they make to U.S. physicians (currently defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals as well as physician ownership and investment interests in the manufacturer, and that such information is subsequently made publicly available in a searchable format on a CMS website, effective January 1, 2022, these reporting obligations will extend to include transfers of value made to certain non-physician assistants and nurse practioners;
|
•
|
provisions of HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; and
|
•
|
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, state transparency reporting and compliance laws; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and which may not have the same effect, thus complicating compliance efforts.
|
|
High
|
|
Low
|
||||
Year Ended December 31, 2018
|
|
|
|
|
|
||
1st Quarter
|
$
|
108.44
|
|
|
$
|
57.40
|
|
2nd Quarter
|
104.45
|
|
|
46.25
|
|
||
3rd Quarter
|
68.49
|
|
|
46.46
|
|
||
4th Quarter
|
56.65
|
|
|
30.43
|
|
||
Year Ended December 31, 2019
|
|
|
|
|
|
||
1st Quarter
|
$
|
46.35
|
|
|
$
|
31.58
|
|
2nd Quarter
|
36.30
|
|
|
31.00
|
|
||
3rd Quarter
|
36.27
|
|
|
16.91
|
|
||
4th Quarter
|
23.12
|
|
|
15.87
|
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
||||||||||
Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenue:
|
|
|
|
|
|
|
|
|
|
||||||||||
Product sales
|
$
|
20,117
|
|
|
$
|
20,774
|
|
|
$
|
32,688
|
|
|
$
|
55,354
|
|
|
$
|
40,155
|
|
Royalty revenue
|
41,222
|
|
|
41,976
|
|
|
33,527
|
|
|
19,542
|
|
|
2,967
|
|
|||||
Non-cash royalty revenue related to sale of future royalties(1)
|
36,303
|
|
|
33,308
|
|
|
30,531
|
|
|
30,158
|
|
|
22,058
|
|
|||||
License, collaboration and other revenue
|
16,975
|
|
|
1,097,265
|
|
|
210,965
|
|
|
60,382
|
|
|
165,604
|
|
|||||
Total revenue
|
114,617
|
|
|
1,193,323
|
|
|
307,711
|
|
|
165,436
|
|
|
230,784
|
|
|||||
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Research and development
|
434,566
|
|
|
399,536
|
|
|
268,461
|
|
|
203,801
|
|
|
182,787
|
|
|||||
Other operating expenses(2)
|
120,086
|
|
|
105,855
|
|
|
98,892
|
|
|
74,490
|
|
|
77,368
|
|
|||||
Total operating costs and expenses(2)
|
554,652
|
|
|
505,391
|
|
|
367,353
|
|
|
278,291
|
|
|
260,155
|
|
|||||
Income (loss) from operations
|
(440,035
|
)
|
|
687,932
|
|
|
(59,642
|
)
|
|
(112,855
|
)
|
|
(29,371
|
)
|
|||||
Non-cash interest expense on liability related to sale of future royalties(1)
|
(25,044
|
)
|
|
(21,196
|
)
|
|
(18,869
|
)
|
|
(19,712
|
)
|
|
(20,619
|
)
|
|||||
Interest income (expense) and other income (expense), net
|
25,025
|
|
|
15,989
|
|
|
(17,565
|
)
|
|
(20,081
|
)
|
|
(16,602
|
)
|
|||||
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(14,079
|
)
|
|||||
Provision (benefit) for income taxes
|
613
|
|
|
1,412
|
|
|
616
|
|
|
876
|
|
|
506
|
|
|||||
Net income (loss)
|
$
|
(440,667
|
)
|
|
$
|
681,313
|
|
|
$
|
(96,692
|
)
|
|
$
|
(153,524
|
)
|
|
$
|
(81,177
|
)
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net income (loss) per share(3)
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic
|
$
|
(2.52
|
)
|
|
$
|
4.02
|
|
|
$
|
(0.62
|
)
|
|
$
|
(1.10
|
)
|
|
$
|
(0.61
|
)
|
Diluted
|
$
|
(2.52
|
)
|
|
$
|
3.78
|
|
|
$
|
(0.62
|
)
|
|
$
|
(1.10
|
)
|
|
$
|
(0.61
|
)
|
Weighted average shares outstanding used in computing net income (loss) per share(3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Basic
|
174,993
|
|
|
169,600
|
|
|
155,953
|
|
|
139,596
|
|
|
132,458
|
|
|||||
Diluted
|
174,993
|
|
|
180,119
|
|
|
155,953
|
|
|
139,596
|
|
|
132,458
|
|
|
As of December 31,
|
||||||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
||||||||||
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash, cash equivalents and investments in
marketable securities
|
$
|
1,603,981
|
|
|
$
|
1,918,239
|
|
|
$
|
353,220
|
|
|
$
|
389,102
|
|
|
$
|
308,944
|
|
Working capital
|
$
|
1,067,657
|
|
|
$
|
1,355,685
|
|
|
$
|
270,657
|
|
|
$
|
353,730
|
|
|
$
|
288,805
|
|
Operating lease right-of-use assets(4)
|
$
|
134,177
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets
|
$
|
1,977,356
|
|
|
$
|
2,150,172
|
|
|
$
|
508,866
|
|
|
$
|
568,871
|
|
|
$
|
498,642
|
|
Deferred revenue
|
$
|
8,071
|
|
|
$
|
24,636
|
|
|
$
|
37,970
|
|
|
$
|
66,239
|
|
|
$
|
83,854
|
|
Senior secured notes, net
|
$
|
248,693
|
|
|
$
|
246,950
|
|
|
$
|
245,207
|
|
|
$
|
243,464
|
|
|
$
|
241,699
|
|
Lease liabilities(4)
|
$
|
155,246
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liability related to the sale of future royalties(1)
|
$
|
72,020
|
|
|
$
|
82,911
|
|
|
$
|
94,655
|
|
|
$
|
105,950
|
|
|
$
|
116,029
|
|
Accumulated deficit
|
$
|
(1,864,718
|
)
|
|
$
|
(1,424,051
|
)
|
|
$
|
(2,117,941
|
)
|
|
$
|
(2,021,010
|
)
|
|
$
|
(1,867,486
|
)
|
Total stockholders’ equity
|
$
|
1,405,391
|
|
|
$
|
1,717,575
|
|
|
$
|
87,828
|
|
|
$
|
88,125
|
|
|
$
|
6,429
|
|
(1)
|
In February 2012, we sold all of our rights to receive future royalty payments on net sales of UCB’s CIMZIA® and Roche’s MIRCERA®. As described in Note 7 to our Consolidated Financial Statements, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period. As a result of this liability accounting, even though the royalties from UCB and Roche are remitted directly to the purchaser of these royalty interests starting in the second quarter of 2012, we will continue to record non-cash revenue for these royalties and related non-cash interest expense.
|
(2)
|
Operating costs and expenses in 2017 includes $16.0 million for the impairment of equipment and related costs resulting from the termination of the Amikacin Inhale development program.
|
(3)
|
Basic net income (loss) per share is based upon the weighted average number of common shares outstanding. Diluted net income (loss) per share is based on the weighted-average number of shares of common stock outstanding, including potentially dilutive securities.
|
(4)
|
On January 1, 2019, we adopted Accounting Standards Codification 842, Leases (ASC 842). As described in Note 1 to our Consolidated Financial Statements, ASC 842 generally requires an entity to recognize a lease liability for leases with a term greater than one year, measured as the present value of the lease payments, with an offset to a right-of-use asset. See Note 6 to our Consolidated Financial Statements for additional information on our leases.
|
|
Year Ended December 31,
|
|
Increase/
(Decrease)
|
|
Percentage
Increase/
(Decrease)
|
|||||||||
|
2019
|
|
2018
|
|
2019 vs. 2018
|
|
2019 vs. 2018
|
|||||||
Product sales
|
$
|
20,117
|
|
|
$
|
20,774
|
|
|
$
|
(657
|
)
|
|
(3
|
)%
|
Royalty revenue
|
41,222
|
|
|
41,976
|
|
|
(754
|
)
|
|
(2
|
)%
|
|||
Non cash royalty revenue related to sale of future royalties
|
36,303
|
|
|
33,308
|
|
|
2,995
|
|
|
9
|
%
|
|||
License, collaboration and other revenue
|
16,975
|
|
|
1,097,265
|
|
|
(1,080,290
|
)
|
|
(98
|
)%
|
|||
Total revenue
|
$
|
114,617
|
|
|
$
|
1,193,323
|
|
|
$
|
(1,078,706
|
)
|
|
(90
|
)%
|
|
Year Ended December 31,
|
|
Increase/
(Decrease)
2019 vs.
2018
|
|
Percentage
Increase/
(Decrease)
2019 vs.
2018
|
|||||||||
|
2019
|
|
2018
|
|
|
|||||||||
Cost of goods sold
|
$
|
21,374
|
|
|
$
|
24,412
|
|
|
$
|
(3,038
|
)
|
|
(12
|
)%
|
Product gross profit
|
(1,257
|
)
|
|
(3,638
|
)
|
|
2,381
|
|
|
(65
|
)%
|
|||
Product gross margin
|
(6
|
)%
|
|
(18
|
)%
|
|
|
|
|
|
Year Ended December 31,
|
Increase/
(Decrease)
2019 vs.
2018
|
|
Percentage
Increase/
(Decrease)
2019 vs.
2018
|
||||||||||
|
2019
|
|
2018
|
|
|
|||||||||
Research and development expense
|
$
|
434,566
|
|
|
$
|
399,536
|
|
|
$
|
35,030
|
|
|
9
|
%
|
|
Clinical
Study
Status(1)
|
|
Year Ended December 31,
|
||||||
|
|
2019
|
|
2018
|
|||||
Bempegaldesleukin (CD122-preferential IL-2 pathway agonist)(2)
|
Phase 1/2/3
|
|
$
|
109,355
|
|
|
$
|
98,024
|
|
NKTR-181 (orally-available mu-opioid analgesic molecule)(3)
|
Terminated
|
|
29,830
|
|
|
56,272
|
|
||
NKTR-358 (cytokine Treg stimulant)
|
Phase 1
|
|
27,319
|
|
|
17,002
|
|
||
ONZEALDTM (next-generation topoisomerase I inhibitor)
|
Terminated
|
|
12,733
|
|
|
9,205
|
|
||
NKTR-255 (IL-15 receptor agonist)
|
Phase 1
|
|
12,278
|
|
|
12,981
|
|
||
NKTR-262 (toll-like receptor agonist)
|
Phase 1
|
|
11,379
|
|
|
9,847
|
|
||
Other product candidates
|
Various
|
|
18,585
|
|
|
3,608
|
|
||
Total clinical development, contract manufacturing and other third party costs
|
|
|
221,479
|
|
|
206,939
|
|
||
Personnel, overhead and other costs(4)
|
|
|
141,719
|
|
|
130,837
|
|
||
Stock-based compensation and depreciation
|
|
|
71,368
|
|
|
61,760
|
|
||
Research and development expense
|
|
|
$
|
434,566
|
|
|
$
|
399,536
|
|
(1)
|
Clinical Study Status definitions are provided in the chart found in Part I, Item 1. Business.
|
(2)
|
Development expenses for bempegaldesleukin include expenses under the BMS Collaboration Agreement, other collaboration agreements and our own independent studies. The amounts for the years ended December 31, 2019 and 2018 include $70.5 million and $47.1 million, respectively, of development cost reimbursements from BMS under our collaboration, net of our share of BMS’ costs.
|
(3)
|
As described in Note 14 to our Consolidated Financial Statements, we withdrew our NDA for NKTR-181 and will make no further investment in the program. As a result, in the first quarter of 2020, we expect to incur charges of $45.0 million to $45.0 million, including noncash charges of $19.7 million for the impairment of advance payments to contract manufacturers for commercial batches of NKTR-181, as well as other charges, primarily for non-cancellable commitments to our contract manufacturers and certain severance costs.
|
(4)
|
The amounts for the year ended December 31, 2019 and 2018 include $34.9 million and $15.6 million of employee cost reimbursements from BMS under our collaboration.
|
•
|
the number of patients required for a given clinical study design;
|
•
|
the length of time required to enroll clinical study participants;
|
•
|
the number and location of sites included in the clinical studies;
|
•
|
the clinical study designs required by the health authorities (i.e. primary and secondary endpoints as well as the size of the study population needed to demonstrate efficacy and safety outcomes);
|
•
|
the potential for changing standards of care for the target patient population;
|
•
|
the competition for patient recruitment from competitive drug candidates being studied in the same clinical setting;
|
•
|
the costs of producing supplies of the drug candidates needed for clinical trials and regulatory submissions;
|
•
|
the safety and efficacy profile of the drug candidate;
|
•
|
the use of clinical research organizations to assist with the management of the trials; and
|
•
|
the costs and timing of, and the ability to secure, approvals from government health authorities.
|
|
Year Ended December 31,
|
Increase/
(Decrease)
2019 vs. 2018
|
|
Percentage
Increase/
(Decrease)
2019 vs.
2018
|
||||||||||
|
2019
|
|
2018
|
|
|
|||||||||
General and administrative expense
|
$
|
98,712
|
|
|
$
|
81,443
|
|
|
$
|
17,269
|
|
|
21
|
%
|
|
Year Ended December 31,
|
Increase/
(Decrease) 2019 vs. 2018 |
|
Percentage Increase/
(Decrease) 2019 vs. 2018 |
||||||||||
|
2019
|
|
2018
|
|
|
|||||||||
Interest expense
|
$
|
21,310
|
|
|
$
|
21,582
|
|
|
$
|
(272
|
)
|
|
(1
|
)%
|
|
Year Ended December 31,
|
|
Increase/
(Decrease) 2019 vs. 2018 |
|
Percentage
Increase/ (Decrease) 2019 vs. 2018 |
|||||||||
|
2019
|
|
2018
|
|
|
|
|
|||||||
Non-cash royalty revenue related to sale of future royalties
|
$
|
36,303
|
|
|
$
|
33,308
|
|
|
$
|
2,995
|
|
|
9
|
%
|
Non-cash interest expense on liability related to sale of future royalties
|
25,044
|
|
|
21,196
|
|
|
3,848
|
|
|
18
|
%
|
|
Year Ended December 31,
|
|
Increase/
(Decrease)
2019 vs. 2018
|
|
Percentage
Increase/
(Decrease)
2019 vs. 2018
|
|||||||||
|
2019
|
|
2018
|
|
|
|
|
|||||||
Interest income and other income (expense), net
|
$
|
46,335
|
|
|
$
|
37,571
|
|
|
$
|
8,764
|
|
|
23
|
%
|
|
Payments Due by Period
|
||||||||||||||||||
|
Total
|
|
<=1 Yr
2020
|
|
2-3 Yrs
2021-2022
|
|
4-5 Yrs
2023-2024
|
|
2025+
|
||||||||||
Obligations(1)
|
|
|
|
|
|
|
|
|
|
||||||||||
7.75% senior secured notes due October 2020, including interest (2)
|
$
|
269,106
|
|
|
$
|
269,106
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating leases(3)
|
237,072
|
|
|
16,832
|
|
|
43,738
|
|
|
46,498
|
|
|
130,004
|
|
|||||
Purchase commitments(4)
|
25,819
|
|
|
25,819
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
|
$
|
531,997
|
|
|
$
|
311,757
|
|
|
$
|
43,738
|
|
|
$
|
46,498
|
|
|
$
|
130,004
|
|
(1)
|
The above table does not include certain commitments and contingencies which are discussed in Note 8 to our Consolidated Financial Statements.
|
(2)
|
The amount reflects the repayment of the principal and interest payments through the maturity of the Notes in October 2020. However, we expect to redeem the Notes in the second quarter of 2020 and therefore expect to pay interest only through the redemption date.
|
(3)
|
These amounts primarily result from our Mission Bay Facility and Third Street Facility leases, which both expire in 2030. The leases are discussed in Note 6 to our Consolidated Financial Statements. Our commitment for the Third Street Facility lease includes certain fixed amounts payable that we have excluded from our lease commitment disclosed in Note 6 to our Consolidated Financial Statements.
|
(4)
|
Substantially all of this amount was subject to open purchase orders as of December 31, 2019 that were issued under existing contracts. This amount does not represent minimum contract termination liabilities for our existing contracts.
|
|
Page
|
|
|
Accounting for accrued research and development expenses
|
|
|
|
Description of the Matter
|
|
As more fully described in Note 1 to the consolidated financial statements, the Company records expenses and accruals for estimated costs of research and development activities, including third party contract services costs for clinical research and contract manufacturing. Clinical trial and contract manufacturing activities performed by third parties are expensed based upon estimates of work completed in accordance with agreements with the respective Clinical Research Organization (“CRO”) or Contract Manufacturing Organization (“CMO”). Billing terms and payments are reviewed by management to ensure estimates of outstanding obligations are appropriate as of period end. Tracking the progress of completion for clinical trial and contract manufacturing activities performed by third parties allows the Company to record the appropriate expense and accruals under the terms of the agreements. During 2019, the Company incurred $434.6 million of research and development expenses. The Company recorded an accrued liability of $32.6 million and $7.3 million for clinical trial and contract manufacturing expenses, respectively, as of December 31, 2019.
Auditing the accounting for accrued clinical trial and contract manufacturing expenses is complex because of the high volume of data used in management’s estimates, the assumptions used by management to develop their estimates and verifying the cost and extent of unbilled work performed during the reporting period.
|
|
|
|
How We Addressed the Matter in Our Audit
|
|
We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the accounting for accrued research and development expenses, including the Company’s assessment and estimation of accrued costs for clinical trial and contract manufacturing activities performed by third parties. This assessment was done with the Company’s financial and operational personnel to determine the appropriate project status and estimated accrual of costs.
To test the Company’s accounting for accrued clinical trial and contract manufacturing expenses, our audit procedures included, among others, obtaining supporting evidence from third parties of the research and development activities performed for significant clinical trials and contract manufacturing services. We agreed, on a sample basis, the Company schedules to key milestones and completion terms, activities, timing, and costs to signed CMO and CRO contracts in order to evaluate the status of completion and accuracy of invoices received from the vendors. We met with clinical and manufacturing personnel to understand the status of significant research and development activities. We also tested a sample of subsequent payments by agreeing the invoice to the original accrual and the invoice payments to bank statements.
|
|
|
|
|
|
|
|
|
Accounting for cost-sharing under the Bristol-Myers Squibb (BMS) Collaboration Agreement
|
|
|
|
Description of the Matter
|
|
The Company and Bristol-Myers Squibb Company (BMS) both conduct research and development activities under a Strategic Collaboration Agreement for bempegaldesleukin (NKTR-214). As more fully explained in note 10 to the consolidated financial statements, the Company and BMS share certain internal and external development costs under the collaboration agreement. The Company’s research and development costs include external actual and estimated Clinical Research Organizations (“CRO”) and Contract Manufacturing Organization (“CMO”) costs in addition to internal employee costs. BMS provides reports to support their research and development activities performed and costs incurred in the relevant period under the terms of the agreement. Estimates included in each party’s research and development costs are trued up to actuals by each party when known. Eligible costs incurred by each party during the reporting period are offset and the net amount is owed to the party with the excess costs. The Company has a net receivable of $24.0 million from BMS under the collaboration as of December 31, 2019. During a reporting period in which there is a net receivable to the Company, the net amount of BMS’ reimbursement of collaboration expense is recorded as a reduction of research and development expense.
Auditing the cost-sharing under the collaboration agreement was especially challenging because of the complexity of the data used by the Company for determining the actual and estimated research and development activities that are eligible for reimbursement under the collaboration agreement. The research and development expenses include management’s judgment regarding the estimated third party contract service costs for clinical research and contract manufacturing incurred during the reporting period. Additionally, the Company evaluates the costs incurred and activities performed by BMS to assess their eligibility for reimbursement under the agreement.
|
|
|
|
How We Addressed the Matter in Our Audit
|
|
We evaluated the design and tested the operating effectiveness of controls over the accounting for the cost-sharing conducted under the collaboration agreement, including the Company’s assessment and measurement of its and BMS’s activities performed and costs incurred that are eligible for reimbursement. This includes conducting meetings with program management, clinical operations and manufacturing personnel to determine the progress to date under the collaboration and substantiating the calculation of eligible costs and activities.
Our audit procedures included, among others, testing the eligibility of the Company’s research and development costs against the terms of the agreement. We met with Company personnel and reviewed meeting minutes to understand discussions held with BMS during various committee meetings to corroborate our knowledge of the collaboration activities that have occurred to date. We tested the activities reported by the Company and BMS for appropriate classification and disclosure under the collaboration agreement. We obtained an external confirmation from BMS for the net amount owed to the Company.
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
ASSETS
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
96,363
|
|
|
$
|
194,905
|
|
Short-term investments
|
1,228,499
|
|
|
1,140,445
|
|
||
Accounts receivable
|
36,802
|
|
|
43,213
|
|
||
Inventory
|
12,665
|
|
|
11,381
|
|
||
Advance payments to contract manufacturers
|
31,834
|
|
|
26,450
|
|
||
Other current assets
|
15,387
|
|
|
21,293
|
|
||
Total current assets
|
1,421,550
|
|
|
1,437,687
|
|
||
Long-term investments
|
279,119
|
|
|
582,889
|
|
||
Property, plant and equipment, net
|
64,999
|
|
|
48,851
|
|
||
Operating lease right-of-use assets
|
134,177
|
|
|
—
|
|
||
Goodwill
|
76,501
|
|
|
76,501
|
|
||
Other assets
|
1,010
|
|
|
4,244
|
|
||
Total assets
|
$
|
1,977,356
|
|
|
$
|
2,150,172
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
19,234
|
|
|
$
|
5,854
|
|
Accrued compensation
|
11,467
|
|
|
9,937
|
|
||
Accrued clinical trial expenses
|
32,626
|
|
|
14,700
|
|
||
Accrued contract manufacturing expenses
|
7,304
|
|
|
23,841
|
|
||
Other accrued expenses
|
11,414
|
|
|
9,087
|
|
||
Senior secured notes, net
|
248,693
|
|
|
—
|
|
||
Interest payable
|
4,198
|
|
|
4,198
|
|
||
Lease liability, current portion
|
12,516
|
|
|
—
|
|
||
Deferred revenue, current portion
|
5,517
|
|
|
13,892
|
|
||
Other current liabilities
|
924
|
|
|
493
|
|
||
Total current liabilities
|
353,893
|
|
|
82,002
|
|
||
Senior secured notes, net
|
—
|
|
|
246,950
|
|
||
Lease liability, less current portion
|
142,730
|
|
|
—
|
|
||
Liability related to the sale of future royalties, net
|
72,020
|
|
|
82,911
|
|
||
Deferred revenue, less current portion
|
2,554
|
|
|
10,744
|
|
||
Other long-term liabilities
|
768
|
|
|
9,990
|
|
||
Total liabilities
|
571,965
|
|
|
432,597
|
|
||
Commitments and contingencies
|
|
|
|
|
|
||
Stockholders’ equity:
|
|
|
|
|
|
||
Preferred stock, $0.0001 par value; 10,000 shares authorized; no shares designated, issued or outstanding at December 31, 2019 or 2018
|
—
|
|
|
—
|
|
||
Common stock, $0.0001 par value; 300,000 shares authorized; 176,505 shares and 173,530 shares issued and outstanding at December 31, 2019 and 2018, respectively
|
17
|
|
|
17
|
|
||
Capital in excess of par value
|
3,271,097
|
|
|
3,147,925
|
|
||
Accumulated other comprehensive loss
|
(1,005
|
)
|
|
(6,316
|
)
|
||
Accumulated deficit
|
(1,864,718
|
)
|
|
(1,424,051
|
)
|
||
Total stockholders’ equity
|
1,405,391
|
|
|
1,717,575
|
|
||
Total liabilities and stockholders’ equity
|
$
|
1,977,356
|
|
|
$
|
2,150,172
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Revenue:
|
|
|
|
|
|
||||||
Product sales
|
$
|
20,117
|
|
|
$
|
20,774
|
|
|
$
|
32,688
|
|
Royalty revenue
|
41,222
|
|
|
41,976
|
|
|
33,527
|
|
|||
Non-cash royalty revenue related to sale of future royalties
|
36,303
|
|
|
33,308
|
|
|
30,531
|
|
|||
License, collaboration and other revenue
|
16,975
|
|
|
1,097,265
|
|
|
210,965
|
|
|||
Total revenue
|
114,617
|
|
|
1,193,323
|
|
|
307,711
|
|
|||
Operating costs and expenses:
|
|
|
|
|
|
||||||
Cost of goods sold
|
21,374
|
|
|
24,412
|
|
|
30,547
|
|
|||
Research and development
|
434,566
|
|
|
399,536
|
|
|
268,461
|
|
|||
General and administrative
|
98,712
|
|
|
81,443
|
|
|
52,364
|
|
|||
Impairment of equipment and other costs for terminated program
|
—
|
|
|
—
|
|
|
15,981
|
|
|||
Total operating costs and expenses
|
554,652
|
|
|
505,391
|
|
|
367,353
|
|
|||
Income (loss) from operations
|
(440,035
|
)
|
|
687,932
|
|
|
(59,642
|
)
|
|||
Non-operating income (expense):
|
|
|
|
|
|
||||||
Interest expense
|
(21,310
|
)
|
|
(21,582
|
)
|
|
(22,085
|
)
|
|||
Non-cash interest expense on liability related to sale of future royalties
|
(25,044
|
)
|
|
(21,196
|
)
|
|
(18,869
|
)
|
|||
Interest income and other income (expense), net
|
46,335
|
|
|
37,571
|
|
|
4,520
|
|
|||
Total non-operating expense, net
|
(19
|
)
|
|
(5,207
|
)
|
|
(36,434
|
)
|
|||
Income (loss) before provision for income taxes
|
(440,054
|
)
|
|
682,725
|
|
|
(96,076
|
)
|
|||
Provision for income taxes
|
613
|
|
|
1,412
|
|
|
616
|
|
|||
Net income (loss)
|
$
|
(440,667
|
)
|
|
$
|
681,313
|
|
|
$
|
(96,692
|
)
|
|
|
|
|
|
|
||||||
Net income (loss) per share
|
|
|
|
|
|
||||||
Basic
|
$
|
(2.52
|
)
|
|
$
|
4.02
|
|
|
$
|
(0.62
|
)
|
Diluted
|
$
|
(2.52
|
)
|
|
$
|
3.78
|
|
|
$
|
(0.62
|
)
|
Weighted average shares outstanding used in computing net income (loss) per share
|
|
|
|
|
|
||||||
Basic
|
174,993
|
|
|
169,600
|
|
|
155,953
|
|
|||
Diluted
|
174,993
|
|
|
180,119
|
|
|
155,953
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Net income (loss)
|
$
|
(440,667
|
)
|
|
$
|
681,313
|
|
|
$
|
(96,692
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|||
Net unrealized gain (loss) on available-for-sale investments
|
5,693
|
|
|
(2,975
|
)
|
|
(533
|
)
|
|||
Net foreign currency translation gain (loss)
|
(382
|
)
|
|
(1,230
|
)
|
|
785
|
|
|||
Other comprehensive income (loss)
|
5,311
|
|
|
(4,205
|
)
|
|
252
|
|
|||
Comprehensive income (loss)
|
$
|
(435,356
|
)
|
|
$
|
677,108
|
|
|
$
|
(96,440
|
)
|
|
Common
Shares
|
|
Par
Value
|
|
Capital in
Excess of
Par Value
|
|
Accumulated
Other
Comprehensive
Loss
|
|
Accumulated
Deficit
|
|
Total
Stockholders’
Equity
|
|||||||||||
Balance at December 31, 2016
|
153,212
|
|
|
$
|
15
|
|
|
$
|
2,111,483
|
|
|
$
|
(2,363
|
)
|
|
$
|
(2,021,010
|
)
|
|
$
|
88,125
|
|
Shares issued under equity compensation plans
|
6,312
|
|
|
—
|
|
|
59,528
|
|
|
—
|
|
|
—
|
|
|
59,528
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
36,615
|
|
|
—
|
|
|
—
|
|
|
36,615
|
|
|||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
239
|
|
|
252
|
|
|
(239
|
)
|
|
252
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(96,692
|
)
|
|
(96,692
|
)
|
|||||
Balance at December 31, 2017
|
159,524
|
|
|
15
|
|
|
2,207,865
|
|
|
(2,111
|
)
|
|
(2,117,941
|
)
|
|
87,828
|
|
|||||
Shares issued under equity compensation plans
|
5,721
|
|
|
1
|
|
|
61,728
|
|
|
—
|
|
|
—
|
|
|
61,729
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
88,101
|
|
|
—
|
|
|
—
|
|
|
88,101
|
|
|||||
Sale of stock to Bristol-Myers Squibb (Note 10)
|
8,285
|
|
|
1
|
|
|
790,231
|
|
|
—
|
|
|
—
|
|
|
790,232
|
|
|||||
Adoption of new accounting standards
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
12,577
|
|
|
12,577
|
|
|||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,205
|
)
|
|
—
|
|
|
(4,205
|
)
|
|||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
681,313
|
|
|
681,313
|
|
|||||
Balance at December 31, 2018
|
173,530
|
|
|
17
|
|
|
3,147,925
|
|
|
(6,316
|
)
|
|
(1,424,051
|
)
|
|
1,717,575
|
|
|||||
Shares issued under equity compensation plans
|
2,975
|
|
|
—
|
|
|
23,377
|
|
|
—
|
|
|
—
|
|
|
23,377
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
99,795
|
|
|
—
|
|
|
—
|
|
|
99,795
|
|
|||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
5,311
|
|
|
—
|
|
|
5,311
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(440,667
|
)
|
|
(440,667
|
)
|
|||||
Balance at December 31, 2019
|
176,505
|
|
|
$
|
17
|
|
|
$
|
3,271,097
|
|
|
$
|
(1,005
|
)
|
|
$
|
(1,864,718
|
)
|
|
$
|
1,405,391
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
||||||
Net income (loss)
|
$
|
(440,667
|
)
|
|
$
|
681,313
|
|
|
$
|
(96,692
|
)
|
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
|
|
|
|
|
|
||||||
Non-cash royalty revenue related to sale of future royalties
|
(36,303
|
)
|
|
(33,308
|
)
|
|
(30,531
|
)
|
|||
Non-cash interest expense on liability related to sale of future royalties
|
25,044
|
|
|
21,196
|
|
|
18,869
|
|
|||
Stock-based compensation
|
99,795
|
|
|
88,101
|
|
|
36,615
|
|
|||
Depreciation and amortization
|
13,156
|
|
|
10,870
|
|
|
14,741
|
|
|||
Impairment of equipment from terminated program
|
—
|
|
|
—
|
|
|
15,081
|
|
|||
Accretion of discounts, net, and other non-cash transactions
|
(11,394
|
)
|
|
(10,952
|
)
|
|
(881
|
)
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable
|
6,411
|
|
|
(25,505
|
)
|
|
10,664
|
|
|||
Inventory
|
(1,284
|
)
|
|
(655
|
)
|
|
383
|
|
|||
Operating lease right-of-use assets, net of operating lease liabilities
|
13,090
|
|
|
—
|
|
|
—
|
|
|||
Other assets
|
1,190
|
|
|
(31,652
|
)
|
|
(4,800
|
)
|
|||
Accounts payable
|
12,967
|
|
|
971
|
|
|
2,074
|
|
|||
Accrued compensation
|
1,530
|
|
|
1,674
|
|
|
(10,017
|
)
|
|||
Other accrued expenses
|
3,816
|
|
|
27,947
|
|
|
7,277
|
|
|||
Deferred revenue
|
(16,565
|
)
|
|
(15,331
|
)
|
|
(28,269
|
)
|
|||
Other liabilities
|
533
|
|
|
3,545
|
|
|
(14,928
|
)
|
|||
Net cash provided by (used in) operating activities
|
(328,681
|
)
|
|
718,214
|
|
|
(80,414
|
)
|
|||
Cash flows from investing activities:
|
|
|
|
|
|
||||||
Purchases of investments
|
(1,380,865
|
)
|
|
(2,271,250
|
)
|
|
(404,425
|
)
|
|||
Maturities of investments
|
1,614,036
|
|
|
890,957
|
|
|
347,743
|
|
|||
Sales of investments
|
—
|
|
|
11,963
|
|
|
37,549
|
|
|||
Purchases of property, plant and equipment
|
(26,285
|
)
|
|
(14,239
|
)
|
|
(9,676
|
)
|
|||
Sales of property and plant
|
—
|
|
|
2,633
|
|
|
—
|
|
|||
Net cash provided by (used in) investing activities
|
206,886
|
|
|
(1,379,936
|
)
|
|
(28,809
|
)
|
|||
Cash flows from financing activities:
|
|
|
|
|
|
||||||
Issuance of common stock to Bristol-Myers Squibb (Note 10)
|
—
|
|
|
790,231
|
|
|
—
|
|
|||
Proceeds from shares issued under equity compensation plans
|
23,355
|
|
|
61,735
|
|
|
59,522
|
|
|||
Payment of capital lease obligations
|
—
|
|
|
—
|
|
|
(5,131
|
)
|
|||
Net cash provided by financing activities
|
23,355
|
|
|
851,966
|
|
|
54,391
|
|
|||
Effect of exchange rates on cash and cash equivalents
|
(102
|
)
|
|
(101
|
)
|
|
(46
|
)
|
|||
Net increase (decrease) in cash and cash equivalents
|
(98,542
|
)
|
|
190,143
|
|
|
(54,878
|
)
|
|||
Cash and cash equivalents at beginning of year
|
$
|
194,905
|
|
|
$
|
4,762
|
|
|
$
|
59,640
|
|
Cash and cash equivalents at end of year
|
$
|
96,363
|
|
|
$
|
194,905
|
|
|
$
|
4,762
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
||||||
Cash paid for interest
|
$
|
19,199
|
|
|
$
|
19,471
|
|
|
$
|
20,116
|
|
Cash paid for income taxes
|
$
|
555
|
|
|
$
|
618
|
|
|
$
|
556
|
|
Right-of-use assets recognized in exchange for operating lease liabilities
|
$
|
57,691
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Estimated Fair Value at
|
||||||
|
December 31,
2019 |
|
December 31,
2018 |
||||
Cash and cash equivalents
|
$
|
96,363
|
|
|
$
|
194,905
|
|
Short-term investments
|
1,228,499
|
|
|
1,140,445
|
|
||
Long-term investments
|
279,119
|
|
|
582,889
|
|
||
Total cash and investments in marketable securities
|
$
|
1,603,981
|
|
|
$
|
1,918,239
|
|
|
Fair Value
Hierarchy
Level
|
|
Estimated Fair Value at
|
||||||
|
|
December 31,
2019 |
|
December 31,
2018 |
|||||
Corporate notes and bonds
|
2
|
|
$
|
1,132,182
|
|
|
$
|
1,288,986
|
|
Corporate commercial paper
|
2
|
|
375,473
|
|
|
498,048
|
|
||
Obligations of U.S. government agencies
|
2
|
|
—
|
|
|
12,977
|
|
||
Available-for-sale investments
|
|
|
1,507,655
|
|
|
1,800,011
|
|
||
Money market funds
|
1
|
|
83,546
|
|
|
105,656
|
|
||
Certificate of deposit
|
N/A
|
|
6,951
|
|
|
6,760
|
|
||
Cash
|
N/A
|
|
5,829
|
|
|
5,812
|
|
||
Total cash and investments in marketable securities
|
|
|
$
|
1,603,981
|
|
|
$
|
1,918,239
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Raw materials
|
$
|
1,673
|
|
|
$
|
1,846
|
|
Work-in-process
|
8,267
|
|
|
6,403
|
|
||
Finished goods
|
2,725
|
|
|
3,132
|
|
||
Total inventory
|
$
|
12,665
|
|
|
$
|
11,381
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Building and leasehold improvements
|
$
|
93,097
|
|
|
$
|
77,771
|
|
Laboratory equipment
|
36,623
|
|
|
33,806
|
|
||
Computer equipment and software
|
26,910
|
|
|
23,395
|
|
||
Manufacturing equipment
|
22,030
|
|
|
21,339
|
|
||
Furniture, fixtures, and other
|
9,662
|
|
|
7,959
|
|
||
Depreciable property, plant and equipment at cost
|
188,322
|
|
|
164,270
|
|
||
Less: accumulated depreciation
|
(127,875
|
)
|
|
(120,507
|
)
|
||
Depreciable property, plant and equipment, net
|
60,447
|
|
|
43,763
|
|
||
Construction-in-progress
|
4,552
|
|
|
5,088
|
|
||
Property, plant and equipment, net
|
$
|
64,999
|
|
|
$
|
48,851
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Operating lease cost
|
$
|
14,697
|
|
|
$
|
7,972
|
|
|
$
|
4,515
|
|
Variable lease cost
|
6,408
|
|
|
4,497
|
|
|
3,077
|
|
|||
Total lease costs
|
$
|
21,105
|
|
|
$
|
12,469
|
|
|
$
|
7,592
|
|
Year ending December 31,
|
|
||
2020
|
$
|
14,571
|
|
2021
|
19,219
|
|
|
2022
|
19,832
|
|
|
2023
|
20,461
|
|
|
2024
|
21,110
|
|
|
2025 and thereafter
|
118,058
|
|
|
Total lease payments
|
213,251
|
|
|
Less: portion representing interest
|
(54,741
|
)
|
|
Less: lease incentives
|
(3,264
|
)
|
|
Operating lease liabilities
|
155,246
|
|
|
Less: current portion
|
(12,516
|
)
|
|
Operating lease liabilities, less current portion
|
$
|
142,730
|
|
Year ending December 31,
|
|
||
2019
|
$
|
7,914
|
|
2020
|
10,617
|
|
|
2021
|
13,649
|
|
|
2022
|
14,117
|
|
|
2023
|
14,599
|
|
|
2024 and thereafter
|
98,315
|
|
|
Total future minimum lease payments
|
$
|
159,211
|
|
|
Year ended
December 31, 2019 |
|
Period from
inception to December 31, 2019 |
||||
Liability related to the sale of future royalties—beginning balance
|
$
|
84,810
|
|
|
$
|
—
|
|
Proceeds from sale of future royalties
|
—
|
|
|
124,000
|
|
||
Payments from Nektar to RPI
|
—
|
|
|
(10,000
|
)
|
||
Non-cash CIMZIA® and MIRCERA® royalty revenue
|
(36,303
|
)
|
|
(207,142
|
)
|
||
Non-cash interest expense recognized
|
25,044
|
|
|
166,693
|
|
||
Liability related to the sale of future royalties – ending balance
|
73,551
|
|
|
73,551
|
|
||
Less: unamortized transaction costs
|
(1,531
|
)
|
|
(1,531
|
)
|
||
Liability related to the sale of future royalties, net
|
$
|
72,020
|
|
|
$
|
72,020
|
|
|
|
|
|
Year Ended December 31,
|
||||||||||
Partner
|
|
Agreement
|
|
2019
|
|
2018
|
|
2017
|
||||||
Bristol-Myers Squibb
|
|
NKTR-214
|
|
$
|
—
|
|
|
$
|
1,059,768
|
|
|
$
|
—
|
|
Eli Lilly and Company
|
|
NKTR-358
|
|
7,019
|
|
|
11,634
|
|
|
130,087
|
|
|||
Amgen, Inc.
|
|
Neulasta®
|
|
5,000
|
|
|
5,000
|
|
|
5,000
|
|
|||
Baxalta Incorporated / Takeda
|
|
Hemophilia, including ADYNOVATE® and ADYNOVI™
|
|
378
|
|
|
20,328
|
|
|
11,443
|
|
|||
Ophthotech Corporation(1)
|
|
Fovista®
|
|
—
|
|
|
—
|
|
|
19,123
|
|
|||
Bayer Healthcare LLC(1)
|
|
BAY41-6551 (Amikacin Inhale)
|
|
—
|
|
|
—
|
|
|
17,931
|
|
|||
AstraZeneca AB
|
|
MOVANTIK® and MOVENTIG®
|
|
—
|
|
|
—
|
|
|
4,600
|
|
|||
Other
|
|
|
|
4,578
|
|
|
535
|
|
|
22,781
|
|
|||
License, collaboration and other revenue
|
|
|
|
$
|
16,975
|
|
|
$
|
1,097,265
|
|
|
$
|
210,965
|
|
(1)
|
These collaboration agreements were completed as of December 31, 2017.
|
|
For the year ended
December 31, 2019 |
||
Deferred revenue—December 31, 2018
|
$
|
24,636
|
|
Recognition of previously unearned revenue
|
(16,565
|
)
|
|
Deferred revenue—December 31, 2019
|
$
|
8,071
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Cost of goods sold
|
$
|
4,294
|
|
|
$
|
4,629
|
|
|
$
|
2,333
|
|
Research and development
|
63,224
|
|
|
56,193
|
|
|
21,252
|
|
|||
General and administrative
|
32,277
|
|
|
27,279
|
|
|
13,030
|
|
|||
Total stock-based compensation
|
$
|
99,795
|
|
|
$
|
88,101
|
|
|
$
|
36,615
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Average risk-free interest rate
|
1.8
|
%
|
|
2.8
|
%
|
|
2.0
|
%
|
|||
Dividend yield
|
0.0
|
%
|
|
0.0
|
%
|
|
0.0
|
%
|
|||
Average volatility factor
|
62.2
|
%
|
|
61.0
|
%
|
|
54.2
|
%
|
|||
Weighted-average expected life
|
5.6 years
|
|
|
5.1 years
|
|
|
5.3 years
|
|
|||
Weighted-average grant-date fair value of options granted
|
$
|
12.25
|
|
|
$
|
29.86
|
|
|
$
|
20.08
|
|
(1)
|
Aggregate intrinsic value represents the difference between the exercise price of the option and the closing market price of our common stock on December 31, 2019.
|
|
Units Issued
|
|
Weighted-
Average
Grant
Date Fair
Value
|
|
Aggregate
Intrinsic
Value(1)
|
|||||
Balance at December 31, 2018
|
3,320
|
|
|
$
|
41.57
|
|
|
|
||
Granted
|
3,189
|
|
|
23.32
|
|
|
|
|||
Vested and released
|
(1,159
|
)
|
|
36.33
|
|
|
|
|||
Forfeited and canceled
|
(415
|
)
|
|
43.19
|
|
|
|
|||
Balance at December 31, 2019
|
4,935
|
|
|
$
|
30.85
|
|
|
$
|
106,506
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Domestic
|
$
|
(441,494
|
)
|
|
$
|
680,423
|
|
|
$
|
(97,938
|
)
|
Foreign
|
1,440
|
|
|
2,302
|
|
|
1,862
|
|
|||
Income (loss) before provision for income taxes
|
$
|
(440,054
|
)
|
|
$
|
682,725
|
|
|
$
|
(96,076
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Current:
|
|
|
|
|
|
||||||
Federal
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
State
|
139
|
|
|
699
|
|
|
1
|
|
|||
Foreign
|
495
|
|
|
620
|
|
|
580
|
|
|||
Total Current
|
634
|
|
|
1,319
|
|
|
581
|
|
|||
Deferred:
|
|
|
|
|
|
||||||
Federal
|
—
|
|
|
—
|
|
|
—
|
|
|||
State
|
—
|
|
|
—
|
|
|
—
|
|
|||
Foreign
|
(21
|
)
|
|
93
|
|
|
35
|
|
|||
Total Deferred
|
(21
|
)
|
|
93
|
|
|
35
|
|
|||
Provision for income taxes
|
$
|
613
|
|
|
$
|
1,412
|
|
|
$
|
616
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Income tax expense (benefit) at federal statutory rate
|
$
|
(92,411
|
)
|
|
$
|
143,372
|
|
|
$
|
(33,627
|
)
|
Research credits
|
(10,511
|
)
|
|
(17,295
|
)
|
|
(8,038
|
)
|
|||
Sale of future royalties
|
(7,624
|
)
|
|
(6,995
|
)
|
|
(8,236
|
)
|
|||
Stock-based compensation
|
(672
|
)
|
|
(66,716
|
)
|
|
(20,665
|
)
|
|||
Premium on equity issuance
|
—
|
|
|
(12,551
|
)
|
|
—
|
|
|||
Change in valuation allowance
|
104,440
|
|
|
(46,885
|
)
|
|
(186,124
|
)
|
|||
Non-cash interest expense on liability related to sale of future royalties
|
5,259
|
|
|
4,451
|
|
|
6,604
|
|
|||
Non-deductible officers’ compensation
|
737
|
|
|
3,182
|
|
|
2,547
|
|
|||
Tax law changes
|
23
|
|
|
45
|
|
|
248,155
|
|
|||
Other
|
1,372
|
|
|
804
|
|
|
—
|
|
|||
Provision for income taxes
|
$
|
613
|
|
|
$
|
1,412
|
|
|
$
|
616
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Deferred tax assets:
|
|
|
|
||||
Net operating loss carryforwards
|
$
|
399,361
|
|
|
$
|
300,693
|
|
Research and other credits
|
128,015
|
|
|
116,955
|
|
||
Operating lease liabilities
|
36,907
|
|
|
—
|
|
||
Stock-based compensation
|
30,875
|
|
|
21,518
|
|
||
Property, plant and equipment
|
5,021
|
|
|
2,124
|
|
||
Capitalized research expenses
|
3,705
|
|
|
8,072
|
|
||
Reserves and accruals
|
2,934
|
|
|
8,066
|
|
||
Deferred revenue
|
1,908
|
|
|
4,467
|
|
||
Deferred tax assets before valuation allowance
|
608,726
|
|
|
461,895
|
|
||
Valuation allowance for deferred tax assets
|
(575,087
|
)
|
|
(460,455
|
)
|
||
Total deferred tax assets
|
33,639
|
|
|
1,440
|
|
||
Operating lease right-of-use assets
|
(31,718
|
)
|
|
—
|
|
||
Other
|
(1,725
|
)
|
|
(1,270
|
)
|
||
Total deferred tax liabilities
|
(33,443
|
)
|
|
(1,270
|
)
|
||
Net deferred tax assets
|
$
|
196
|
|
|
$
|
170
|
|
|
December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Beginning balance
|
$
|
27,419
|
|
|
$
|
20,483
|
|
|
$
|
18,413
|
|
Tax positions related to current year
|
|
|
|
|
|
||||||
Additions:
|
|
|
|
|
|
||||||
Federal
|
1,365
|
|
|
2,019
|
|
|
1,206
|
|
|||
State
|
48,493
|
|
|
3,645
|
|
|
1,666
|
|
|||
Reductions
|
—
|
|
|
—
|
|
|
—
|
|
|||
Tax positions related to prior year
|
|
|
|
|
|
||||||
Additions:
|
|
|
|
|
|
||||||
Federal
|
—
|
|
|
669
|
|
|
—
|
|
|||
State
|
277
|
|
|
603
|
|
|
—
|
|
|||
Foreign
|
—
|
|
|
—
|
|
|
—
|
|
|||
Reductions
|
(144
|
)
|
|
—
|
|
|
(802
|
)
|
|||
Settlements
|
—
|
|
|
—
|
|
|
—
|
|
|||
Lapses in statute of limitations
|
—
|
|
|
—
|
|
|
—
|
|
|||
Ending balance
|
$
|
77,410
|
|
|
$
|
27,419
|
|
|
$
|
20,483
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
United States
|
$
|
27,093
|
|
|
$
|
1,090,794
|
|
|
$
|
190,810
|
|
Rest of World
|
87,524
|
|
|
102,529
|
|
|
116,901
|
|
|||
Total revenue
|
$
|
114,617
|
|
|
$
|
1,193,323
|
|
|
$
|
307,711
|
|
|
Year Ended December 31, 2019
|
|
Year Ended December 31, 2018
|
||||||||||||||||||||||||||||
|
Q1
|
|
Q2
|
|
Q3
|
|
Q4
|
|
Q1
|
|
Q2
|
|
Q3
|
|
Q4
|
||||||||||||||||
Product sales
|
$
|
4,398
|
|
|
$
|
4,346
|
|
|
$
|
5,558
|
|
|
$
|
5,815
|
|
|
$
|
6,295
|
|
|
$
|
5,863
|
|
|
$
|
4,256
|
|
|
$
|
4,360
|
|
Total revenue
|
$
|
28,222
|
|
|
$
|
23,315
|
|
|
$
|
29,218
|
|
|
$
|
33,862
|
|
|
$
|
38,018
|
|
|
$
|
1,087,717
|
|
|
$
|
27,762
|
|
|
$
|
39,826
|
|
Cost of goods sold
|
$
|
5,440
|
|
|
$
|
5,018
|
|
|
$
|
4,927
|
|
|
$
|
5,989
|
|
|
$
|
6,646
|
|
|
$
|
5,522
|
|
|
$
|
4,783
|
|
|
$
|
7,461
|
|
Research and development expenses
|
$
|
118,463
|
|
|
$
|
106,686
|
|
|
$
|
99,048
|
|
|
$
|
110,369
|
|
|
$
|
99,424
|
|
|
$
|
88,334
|
|
|
$
|
102,895
|
|
|
$
|
108,883
|
|
Operating income (loss)
|
$
|
(120,687
|
)
|
|
$
|
(110,970
|
)
|
|
$
|
(98,740
|
)
|
|
$
|
(109,638
|
)
|
|
$
|
(86,739
|
)
|
|
$
|
973,600
|
|
|
$
|
(98,634
|
)
|
|
$
|
(100,295
|
)
|
Net income (loss) (1)
|
$
|
(119,632
|
)
|
|
$
|
(110,286
|
)
|
|
$
|
(98,585
|
)
|
|
$
|
(112,164
|
)
|
|
$
|
(95,792
|
)
|
|
$
|
971,460
|
|
|
$
|
(96,143
|
)
|
|
$
|
(98,212
|
)
|
Net income (loss) per share(1) (2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Basic
|
$
|
(0.69
|
)
|
|
$
|
(0.63
|
)
|
|
$
|
(0.56
|
)
|
|
$
|
(0.64
|
)
|
|
$
|
(0.60
|
)
|
|
$
|
5.67
|
|
|
$
|
(0.56
|
)
|
|
$
|
(0.57
|
)
|
Diluted
|
$
|
(0.69
|
)
|
|
$
|
(0.63
|
)
|
|
$
|
(0.56
|
)
|
|
$
|
(0.64
|
)
|
|
$
|
(0.60
|
)
|
|
$
|
5.33
|
|
|
$
|
(0.56
|
)
|
|
$
|
(0.57
|
)
|
(1)
|
As discussed in Note 1, in the fourth quarter of 2019, we adopted ASU 2019-12, effective January 1, 2019, which affected previously reported amounts of net loss and net loss per share for the first three quarters of 2019. We have recast such amounts for the effects of adoption.
|
(2)
|
Quarterly income (loss) per share amounts may not total to the year-to-date income (loss) per share due to rounding.
|
(a)
|
The following documents are filed as part of this report:
|
(1)
|
Consolidated Financial Statements:
|
|
Page
|
|
Reports of Independent Registered Public Accounting Firm
|
66
|
|
Consolidated Balance Sheets at December 31, 2019, and 2018
|
68
|
|
Consolidated Statements of Operations for each of the three years in the period ended December 31, 2019
|
69
|
|
Consolidated Statements of Comprehensive Income (Loss) for each of the three years in the period ended December 31, 2019
|
70
|
|
Consolidated Statements of Stockholders’ Equity for each of the three years in the period ended December 31, 2019
|
71
|
|
Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, 2019
|
72
|
|
Notes to Consolidated Financial Statements
|
73
|
|
(2)
|
Financial Statement Schedules:
|
(3)
|
Exhibits.
|
Exhibit
Number
|
|
Description of Documents
|
|
|
|
2.1(1)
|
|
|
|
|
|
3.1(2)
|
|
|
|
|
|
3.2(3)
|
|
|
|
|
|
3.3(4)
|
|
|
|
|
|
3.4(5)
|
|
|
|
|
|
3.5(6)
|
|
|
|
|
|
4.1
|
|
|
|
|
|
4.2(4)
|
|
|
|
|
|
4.3(7)
|
|
|
|
|
|
4.4(28)
|
|
|
|
|
|
Exhibit
Number
|
|
Description of Documents
|
10.1(8)
|
|
|
|
|
|
10.2(8)
|
|
|
|
|
|
10.3(8)
|
|
|
|
|
|
10.4(8)
|
|
|
|
|
|
10.5(8)
|
|
|
|
|
|
10.6(9)
|
|
|
|
|
|
10.7(10)
|
|
|
|
|
|
10.8(11)
|
|
|
|
|
|
10.9(12)
|
|
|
|
|
|
10.10(13)
|
|
|
|
|
|
10.11(14)
|
|
|
|
|
|
10.12(15)
|
|
|
|
|
|
10.13(16)
|
|
|
|
|
|
10.14(1)
|
|
|
|
|
|
10.15(1)
|
|
|
|
|
|
10.16(17)
|
|
|
|
|
|
10.17(28)
|
|
|
|
|
|
10.18(19)
|
|
|
|
|
|
10.19(28)
|
|
|
|
|
|
10.20(16)
|
|
|
|
|
|
Exhibit
Number
|
|
Description of Documents
|
10.21(18)
|
|
|
|
|
|
10.22(20)
|
|
|
|
|
|
10.23(1)
|
|
|
|
|
|
10.24(1)
|
|
|
|
|
|
10.25(17)
|
|
|
|
|
|
10.26(21)
|
|
|
|
|
|
10.27(22)
|
|
|
|
|
|
10.28(18)
|
|
|
|
|
|
10.29(7)
|
|
|
|
|
|
10.30(7)
|
|
|
|
|
|
10.31(23)
|
|
|
|
|
|
10.32(24)
|
|
|
|
|
|
10.33(25)
|
|
|
|
|
|
10.34(25)
|
|
|
|
|
|
10.35(28)
|
|
|
|
|
|
10.36(26)
|
|
|
|
|
|
10.37(27)
|
|
|
|
|
|
Exhibit
Number
|
|
Description of Documents
|
21.1(28)
|
|
|
|
|
|
23.1(28)
|
|
|
|
|
|
24
|
|
|
|
|
|
31.1(28)
|
|
|
|
|
|
31.2(28)
|
|
|
|
|
|
32.1*
|
|
|
|
|
|
101.SCH**
|
|
Inline XBRL Taxonomy Extension Schema Document.
|
101.CAL**
|
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
|
101.LAB**
|
|
Inline XBRL Taxonomy Extension Label Linkbase Document.
|
101.PRE**
|
|
Inline XBRL Taxonomy Extension Presentation Label Linkbase Document.
|
101.DEF**
|
|
Inline XBRL Taxonomy Extension Definition Linkbase Document.
|
104**
|
|
Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101).
|
+
|
Certain confidential portions (indicated by brackets and asterisks) have been omitted from this exhibit in accordance with the rules of the Securities and Exchange Commission.
|
++
|
Management contract or compensatory plan or arrangement.
|
*
|
Exhibit 32.1 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall such exhibit be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Securities Exchange Act, except as otherwise stated in such filing.
|
**
|
Inline XBRL information is filed herewith.
|
(1)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Annual Report on Form 10-K for the year ended December 31, 2008.
|
(2)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly Report on Form 10-Q for the quarter ended June 30, 1998.
|
(3)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2000.
|
(4)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Current Report on Form 8-K, filed on January 23, 2003.
|
(5)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Annual Report on Form 10-K for the year ended December 31, 2009.
|
(6)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Current Report on Form 8-K, filed on December 12, 2019.
|
(7)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Current Report on Form 8-K, filed on October 6, 2015.
|
(8)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Annual Report on Form 10-K for the year ended December 31, 2011.
|
(9)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Current Report on Form 8-K, filed on June 17, 2015.
|
(10)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Current Report on Form 8-K filed on December 17, 2015.
|
(11)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Current Report on Form 8-K, filed on June 27, 2018.
|
(12)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Annual Report on Form 10-K for the year ended December 31, 2018.
|
(13)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Current Report on Form 8-K, filed on June 27, 2014.
|
(14)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Annual Report on Form 10-K for the year ended December 31, 2012.
|
(15)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended June 30, 2004.
|
(16)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2007.
|
(17)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Annual Report on Form 10-K for the year ended December 31, 2010.
|
(18)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2017.
|
(19)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2019.
|
(20)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2006.
|
(21)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2009.
|
(22)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2016.
|
(23)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2012.
|
(24)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2013.
|
(25)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2018.
|
(26)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Current Report on Form 8-K filed on February 14, 2018.
|
(27)
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2018.
|
(28)
|
Filed herewith.
|
Item 16.
|
Form 10-K Summary
|
By:
|
/s/ GIL M. LABRUCHERIE
|
|
Gil M. Labrucherie
|
|
Senior Vice President, Chief Operating Officer, and Chief Financial Officer
|
By:
|
/s/ JILLIAN B. THOMSEN
|
|
Jillian B. Thomsen
|
|
Senior Vice President, Finance and Chief Accounting Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ HOWARD W. ROBIN
|
|
Chief Executive Officer, President and Director
|
|
February 27, 2020
|
Howard W. Robin
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/s/ GIL M. LABRUCHERIE
|
|
Senior Vice President, Chief Operating Officer, and Chief Financial Officer
|
|
February 27, 2020
|
Gil M. Labrucherie
|
|
(Principal Financial Officer)
|
|
|
|
|
|
|
|
/s/ JILLIAN B. THOMSEN
|
|
Senior Vice President, Finance and Chief Accounting Officer
|
|
February 27, 2020
|
Jillian B. Thomsen
|
|
(Principal Accounting Officer)
|
|
|
|
|
|
|
|
/s/ ROBERT B. CHESS
|
|
Director, Chairman of the Board of Directors
|
|
February 27, 2020
|
Robert B. Chess
|
|
|
|
|
|
|
|
|
|
/s/ JEFFREY R. AJER
|
|
Director
|
|
February 27, 2020
|
Jeffrey R. Ajer
|
|
|
|
|
|
|
|
|
|
/s/ MYRIAM J. CURET
|
|
Director
|
|
February 27, 2020
|
Myriam J. Curet
|
|
|
|
|
|
|
|
|
|
/s/ KARIN EASTHAM
|
|
Director
|
|
February 27, 2020
|
Karin Eastham
|
|
|
|
|
|
|
|
|
|
/s/ R. SCOTT GREER
|
|
Director
|
|
February 27, 2020
|
R. Scott Greer
|
|
|
|
|
|
|
|
|
|
/s/ LUTZ LINGNAU
|
|
Director
|
|
February 27, 2020
|
Lutz Lingnau
|
|
|
|
|
|
|
|
|
|
/s/ ROY A. WHITFIELD
|
|
Director
|
|
February 27, 2020
|
Roy A. Whitfield
|
|
|
|
|
/s/ HOWARD W. ROBIN
|
Howard W. Robin
|
Chief Executive Officer, President and Director
|
/s/ GIL M. LABRUCHERIE
|
Gil M. Labrucherie
|
Senior Vice President, Chief Operating Officer, and Chief Financial Officer
|
/s/ HOWARD W. ROBIN
|
|
/s/ GIL M. LABRUCHERIE
|
Howard W. Robin
|
|
Gil M. Labrucherie
|
Chief Executive Officer, President and Director
|
|
Senior Vice President, Chief Operating Officer, and Chief Financial Officer
|
*
|
This certification accompanies the Annual Report on Form 10-K, to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.
|