Company Quick10K Filing
Quick10K
Ligand Pharmaceuticals
10-K 2018-12-31 Annual: 2018-12-31
10-Q 2018-09-30 Quarter: 2018-09-30
10-Q 2018-06-30 Quarter: 2018-06-30
10-Q 2018-03-31 Quarter: 2018-03-31
10-K 2017-12-31 Annual: 2017-12-31
10-Q 2017-09-30 Quarter: 2017-09-30
10-Q 2017-06-30 Quarter: 2017-06-30
10-Q 2017-03-31 Quarter: 2017-03-31
10-K 2016-12-31 Annual: 2016-12-31
10-Q 2016-09-30 Quarter: 2016-09-30
10-Q 2016-06-30 Quarter: 2016-06-30
10-Q 2016-03-31 Quarter: 2016-03-31
10-K 2015-12-31 Annual: 2015-12-31
10-Q 2015-09-30 Quarter: 2015-09-30
10-Q 2015-06-30 Quarter: 2015-06-30
10-Q 2015-03-31 Quarter: 2015-03-31
10-K 2014-12-31 Annual: 2014-12-31
10-Q 2014-09-30 Quarter: 2014-09-30
10-Q 2014-06-30 Quarter: 2014-06-30
10-Q 2014-03-31 Quarter: 2014-03-31
10-K 2013-12-31 Annual: 2013-12-31
8-K 2019-03-12 Regulation FD, Exhibits
8-K 2019-02-07 Earnings, Exhibits
8-K 2019-02-04 Other Events
8-K 2019-01-23 Other Events
8-K 2019-01-23 Other Events
8-K 2019-01-23 Officers
8-K 2019-01-23 Officers
8-K 2018-12-17 Enter Agreement, Exhibits
8-K 2018-11-09 Other Events
8-K 2018-11-08 Earnings, Exhibits
8-K 2018-10-10 M&A, Exhibits
8-K 2018-10-08 Other Events
8-K 2018-09-24 Other Events
8-K 2018-08-09 Enter Agreement, Exhibits
8-K 2018-08-06 Earnings, Exhibits
8-K 2018-07-30 Other Events, Exhibits
8-K 2018-07-11 Other Events
8-K 2018-06-27 Enter Agreement, Regulation FD, Exhibits
8-K 2018-06-19 Shareholder Vote
8-K 2018-05-22 Enter Agreement, Off-BS Arrangement, Sale of Shares, Exhibits
8-K 2018-05-18 Other Events, Exhibits
8-K 2018-05-10 Other Events
8-K 2018-05-08 Earnings, Exhibits
8-K 2018-04-13 Off-BS Arrangement, Other Events
8-K 2018-03-22 Enter Agreement
8-K 2018-03-06 Enter Agreement, Regulation FD, Other Events
8-K 2018-02-21 Earnings, Exhibits
8-K 2018-01-29 Officers
KOS Kosmos Energy 0
BSAC Banco Santander Chile 0
MVO MV Oil Trust 0
XENT Intersect Ent 0
IRET Investors Real Estate Trust 0
AUMN Golden Minerals 0
EFOI Energy Focus 0
PAGP Plains Gp Holdings 0
SURF Surface Oncology 0
ASRV Ameriserv Financial 0
LGND 2018-12-31
Part I
Item 1.Business
Item 1A.Risk Factors
Item 1B.Unresolved Staff Comments
Item 2.Properties
Item 3.Legal Proceedings
Item 4.Mine Safety Disclosures
Part II
Item 5.Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities
Item 6.Selected Consolidated Financial Data
Item 7.Management's Discussion and Analysis of Financial Condition and Results of Operations
Item 7A.Quantitative and Qualitative Disclosures About Market Risk
Item 8.Consolidated Financial Statements and Supplementary Data
Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Item 9A.Controls and Procedures
Item 9B.Other Information
Part III
Item 10.Directors, Executive Officers and Corporate Governance
Item 11.Executive Compensation
Item 11 Is Hereby Incorporated By Reference To Ligand's Definitive Proxy Statement To Be Filed with The Sec Within 120 Days of December 31, 2018.
Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Item 12 Is Hereby Incorporated By Reference To Ligand's Definitive Proxy Statement To Be Filed with The Sec Within 120 Days of December 31, 2018.
Item 13.Certain Relationships and Related Transactions, and Director Independence
Item 13 Is Hereby Incorporated By Reference To Ligand's Definitive Proxy Statement To Be Filed with The Sec Within 120 Days of December 31, 2018.
Item 14.Principal Accountant Fees and Services
Item 14 Is Hereby Incorporated By Reference To Ligand's Definitive Proxy Statement To Be Filed with The Sec Within 120 Days of December 31, 2018.
Part IV
Item 15.Exhibits and Financial Statement Schedule
Item 16.Form 10-K Summary
EX-10.48 lgnd123118exhibit1048-.htm
EX-21.1 lgnd123118exhibit211-n.htm
EX-23.1 lgnd123118exhibit231-n.htm
EX-31.1 lgnd123118exhibit311-n.htm
EX-31.2 lgnd123118exhibit312-n.htm
EX-32.1 lgnd123118exhibit321-n.htm

Ligand Pharmaceuticals Earnings 2018-12-31

LGND 10K Annual Report

Balance SheetIncome StatementCash Flow

Document
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________________________________________________________________________________
FORM 10-K
_____________________________________________________________________________________________

xANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Fiscal Year Ended December 31, 2018
OR
oTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from              to             .

Commission File No. 001-33093

lgnd-20181231_g1.gif
LIGAND PHARMACEUTICALS INCORPORATED
(Exact name of registrant as specified in its charter)
Delaware77-0160744
(State or other jurisdiction of
incorporation or organization)
(IRS Employer
Identification No.)
3911 Sorrento Valley Boulevard, Suite 110
San Diego, CA
92121 
(Address of Principal Executive Offices)(Zip Code)
Registrant’s telephone number, including area code: (858) 550-7500
Securities registered pursuant to Section 12(b) of the Act:
Title of Each ClassName of Each Exchange on Which Registered
Common Stock, par value $.001 per shareThe Nasdaq Global Market of The Nasdaq Stock Market LLC
Securities registered pursuant to Section 12(g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    Yes  x    No  o 
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934.    Yes  o    No  x
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  o
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes  x    No  o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and "emerging growth company" in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer  x
Accelerated Filer  o
Non-accelerated Filer  o
Smaller reporting company  o
Emerging growth company  o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2 of the Exchange Act).    Yes  o    No  x




The aggregate market value of the Registrant’s voting and non-voting stock held by non-affiliates was approximately $3.6 billion based on the last sales price of the Registrant’s Common Stock on the Nasdaq Global Market of the Nasdaq Stock Market LLC on June 29, 2018. For purposes of this calculation, shares of Common Stock held by directors, officers and 10% stockholders known to the Registrant have been deemed to be owned by affiliates which should not be construed to indicate that any such person possesses the power, direct or indirect, to direct or cause the direction of the management or policies of the Registrant or that such person is controlled by or under common control with the Registrant.

As of February 25, 2019, the Registrant had 20,445,407 shares of Common Stock outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the Proxy Statement for the Registrant’s 2019 Annual Meeting of Stockholders to be filed with the Commission within 120 days of December 31, 2018 are incorporated by reference in Part III of this Annual Report on Form 10-K. With the exception of those portions that are specifically incorporated by reference in this Annual Report on Form 10-K, such Proxy Statement shall not be deemed filed as part of this Report or incorporated by reference herein.





Table of Contents
 
Part I
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
Part II
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Part III
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
Part IV
Item 15.
Item 16.























GLOSSARY OF TERMS AND ABBREVIATIONS 
Abbreviation Definition 
2019 Notes $245.0 million aggregate principal amount of convertible senior unsecured notes due 2019 
2023 Notes $750.0 million aggregate principal amount of convertible senior unsecured notes due 2023 
AACR American Association for Cancer Research 
ADHF Acute decompensated heart failure 
Amended Interest Purchase Agreement
Amended and Restated Interest Purchase Agreement, dated May 31, 2017, between the Company and CorMatrix Cardiovascular, Inc.
AldeyraAldeyra Therapeutics, Inc. 
AMDAge-related macular degeneration 
AmgenAmgen, Inc. 
ANDA Abbreviated New Drug Application 
API Active pharmaceutical ingredient
Apricus Apricus Biosciences, Inc.
AptevoAptevo Therapeutics 
Arcus Arcus Biosciences, Inc.
ASCAccounting Standards Codification 
ASCOAmerican Society of Clinical Oncology 
ASCTAutologous Stem Cell Transplantation
ASH American Society of Hematology 
ASU Accounting Standards Update  
Aziyo Aziyo Med, LLC 
Azure Azure Biotech, Inc. 
Baxter Baxter International, Inc. 
BiTE
Bispecific T cell engager
BMS Bristol Myers Squibb 
C-Stone
CStone Pharmaceuticals Co., Ltd.
CASI CASI Pharmaceuticals, Inc.
Cardioxyl Cardioxyl Pharmaceuticals, Inc.
Code of Conduct
Code of Conduct and Ethics Policy
CoherusCoherus Biosciences, Inc.
CoMComposition of Matter
Company Ligand Pharmaceuticals Incorporated, including subsidiaries 
Convertible Note
Senior Convertible Promissory Note
COPD Chronic obstructive pulmonary disease  
Cormatrix 
Cormatrix Cardiovascular Inc.
Cormatrix Asset Sale
Asset sale from CorMatrix to Aziyo
Corvus Corvus Pharmaceuticals, Inc. 
COSO Committee of Sponsoring Organizations of the Treadway Commission 
CRO Contract Research Organization 
CrystalCrystal Bioscience, Inc.
CStoneCStone Pharmaceuticals
CURxCURx Pharmaceuticals, Inc.
CVR Contingent value right 
CyDexCyDex Pharmaceuticals, Inc.
Daiichi Sankyo
Daiichi Sankyo Company, LTD



Dianomi Dianomi Therapeutics 
DMF Drug Master File 
Eisai
Eisai Inc.
Eli LillyEli Lilly and Company
EMCExtracellular matrix
EPORErythropoietin receptor
ESPPEmployee Stock Purchase Plan, as amended and restated 
EU European Union 
Exelixis
Exelixis, Inc.
FASB Financial Accounting Standards Board 
FDA Food and Drug Administration 
Fred Hutch The Fred Hutchinson Cancer Research Center 
FSGS Focal segmental glomerulosclerosis 
GAAPGenerally accepted accounting principles in the United States
GCSFGranulocyte-colony stimulating factor
GRA Glucagon receptor antagonist
HanAll
HanAll Biopharma Co., Ltd.
Harbour Harbour BioMed
HCO Heavy-chain-only
HNO Nitroxyl
Hovione Hovione FarmCiencia
IPR&D In-Process Research and Development 
IRAK4Interleukin-1 Receptor Associated Kinase-4
IRS Internal Revenue Service 
ITP Chronic immune (idiopathic) thrombocytopenic purpura 
IV Intravenous 
iMBP iMetabolic Biopharma Corporation  
Immunovant 
Immunovant Sciences GmbH
IND Investigational New Drug 
Original Interest Purchase Agreement
Interest Purchase Agreement, dated May 3, 2016, between the Company and CorMatrix Cardiovascular, Inc.
KSQ Therapeutics KSQ Therapeutics, Inc. 
Ligand Ligand Pharmaceuticals Incorporated, including subsidiaries 
Loan and Security Agreement
Loan and Security Agreement, dated May 21, 2014, between the Company and Viking, as amended by the First Amendment to Loan and Security Agreement, dated April 8, 2015, and the Second Amendment to Loan and Security Agreement, dated January 22, 2016
LTP Liver-targeted prodrug 
Lundbeck Lundbeck A/S 
Marinus
Marinus Pharmaceuticals, Inc. 
MCM Mineral Coated Microparticle 
MDS Myelodysplastic syndromes 
Melinta Melinta Therapeutics, Inc. 
Merck Merck & Co., Inc.
MerrimackMerrimack Pharmaceuticals, Inc.
Metabasis Metabasis Therapeutics, Inc. 
Metavant
Metavant Sciences 
MLA Master License Agreement 
MRSA Methicillin-resistant Staphylococcus aureu 



NASH Non-alcoholic steatohepatitis
NDA New Drug Application 
NOLs Net Operating Losses 
NovartisNovartis AG
OMT Open Monoclonal Technology, Inc.
Omthera Omthera Pharmaceuticals, Inc. 
Ono Ono Pharmaceutical Co., Ltd.
Orange Book Publication identifying drug products approved by the FDA based on safety and effectiveness
Palvella Palvella Therapeutics, Inc. 
Par Par Pharmaceutical, Inc. 
PDUFAPrescription Drug User Fee Act
PfizerPfizer Inc.
PharmacopeiaPharmacopeia, Inc.
Phoenix TissuePhoenix Tissue Repair
PPDPost-Partum Depression
PSUPerformance stock unit
Retrophin Retrophin Inc. 
Roivant Roivant Sciences GMBH 
RSU  Restricted stock unit 
SAA Severe Aplastic Anemia 
SAGE Sage Therapeutics, Inc. 
SARM Selective Androgen Receptor Modulator 
SEC Securities and Exchange Commission 
Sedor Sedor Pharmaceuticals, Inc., or RODES, Inc. 
Seelos Seelos Therapeutics, Inc. 
Selexis Selexis, SA 
SermonixSermonix Pharmaceuticals, LLC
Spectrum Spectrum Pharmaceuticals, Inc. 
Sunshine Lake PharmaSunshine Lake Pharma Co., Ltd.
Syros  Syros Pharmaceuticals, Inc.  
TakedaTakeda Pharmaceuticals Company Limited
Tax ActThe Tax Cuts and Jobs Act
TevaTeva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd. and Actavis, LLC
TG Therapeutics TG Therapeutics, Inc. 
TPE Third-party evidence 
TR-BetaThyroid hormone receptor beta
VDP
Vernalis Design Platform
VentiRxVentiRx Pharmaceuticals Inc.
Vernalis Vernalis plc 
Verona Verona Pharma plc 
Viking Viking Therapeutics
VireoVireo Health
WuXi WuXi Biologics Ireland Limited 
WuXi Agreement
The Platform License Agreement, dated March 23, 2015, by and between Ligand and WuXi, as amended
X-ALD X-linked adrenoleukodystrophy 
Zydus CadilaZydus Cadila Healthcare Ltd




PART I


Cautionary Note Regarding Forward-Looking Statements:
You should read the following report together with the more detailed information regarding our company, our common stock and our financial statements and notes to those statements appearing elsewhere in this document.

This report contains forward-looking statements that involve a number of risks and uncertainties. Although our forward-looking statements reflect the good faith judgment of our management, these statements can only be based on facts and factors currently known by us. Consequently, these forward-looking statements are inherently subject to risks and uncertainties, and actual results and outcomes may differ materially from results and outcomes discussed in the forward-looking statements.

Forward-looking statements can be identified by the use of forward-looking words such as “believes,” “expects,” “may,” “will,” “plan,” “intends,” “estimates,” “would,” “continue,” “seeks,” “pro forma,” or “anticipates,” or other similar words (including their use in the negative), or by discussions of future matters such as those related to our future results of operations and financial position, royalties and milestones under license agreements, Capitsol material sales, product development, and product regulatory filings and approvals, and the timing thereof, as well as other statements that are not historical. You should be aware that the occurrence of any of the events discussed under the caption “Risk Factors” could negatively affect our results of operations and financial condition and the trading price of our stock.

The cautionary statements made in this report are intended to be applicable to all related forward-looking statements wherever they may appear in this report. We urge you not to place undue reliance on these forward-looking statements, which speak only as of the date of this report. Except as required by law, we assume no obligation to update our forward-looking statements, even if new information becomes available in the future. This caution is made under the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, as amended.

References to “Ligand Pharmaceuticals Incorporated,” “Ligand,” the “Company,” “we,” “our” and “us” include Ligand Pharmaceuticals Incorporated and our wholly-owned subsidiaries.

Partner Information

Information regarding partnered products and programs comes from information publicly released by our partners and licensees.

Trademarks

Our trademarks, trade names and service marks referenced herein include Ligand®, Captisol®, Captisol-enabled™, LTP technology™, OmniAb®, OmniMouse®, OmniRat®, OmniFlic® and OmniChickenTM which are protected under applicable intellectual property laws and are our property. All other trademarks, trade names and service marks including BaxdelaTM, CarnexivTM, Conbriza®, Duavee®, Evomela®,Kyprolis®, Promacta®, Revolade®, SUREtechnology Platform™, Viviant®, Vivitra®, Bryxta®, and Exemptia® are the property of their respective owners. Solely for convenience, trademarks, trade names and service marks referred to in this report may appear without the ®, ™ or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to such trademarks, trade names and service marks. Use or display by us of other parties’ trademarks, trade dress or products is not intended to and does not imply a relationship with, or endorsement or sponsorship of, us by the trademark or trade dress owners.













Item 1.Business

Overview
We are a biopharmaceutical company focused on developing and acquiring technologies that help pharmaceutical companies discover and develop medicines. Over our more than 30 year history, we have employed research technologies such as nuclear receptor assays, high throughput computer screening, formulation science, liver targeted pro-drug technologies and antibody discovery technologies to assist companies in their work toward securing prescription drug approvals. We currently have partnerships and license agreements with over 110 pharmaceutical and biotechnology companies. Over 200 different programs under license with us are currently in various stages of commercialization and development. We have contributed novel research and technologies for approved medicines that treat cancer, osteoporosis, fungal infections and low blood platelets, among others. Our partners have programs currently in clinical development targeting seizure, coma, cancer, diabetes, cardiovascular disease, muscle wasting, liver disease, and kidney disease, among others. We have over 1,200 issued patents worldwide.
We have assembled our large portfolio of fully-funded programs either by licensing our own proprietary drug development programs, licensing our platform technologies such as Captisol or OmniAb to partners for use with their proprietary programs, or acquiring existing partnered programs from other companies. Fully-funded programs, which we refer to as "shots on goal," are those for which our partners pay all of the development and commercialization costs. For our internal programs, we generally plan to advance drug candidates through early-stage drug development or clinical proof-of-concept and then seek partners to continue development and potential commercialization.

Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) to ultimately generate our revenue. We believe that focusing on discovery and early-stage drug development while benefiting from our partners’ development and commercialization expertise will reduce our internal expenses and allow us to have a larger number of drug candidates progress to later stages of drug development.
Our revenue consists of three primary elements: royalties from commercialized products, license and milestone payments and sale of Captisol material. In addition to discovering and developing our own proprietary drugs, we selectively pursue acquisitions to bring in new assets, pipelines, and technologies to aid in generating additional potential new revenue streams.
2018 and Recent Major Business Highlights
Acquisitions and Other Business Development

In October 2018, we acquired Vernalis, a structure-based drug discovery biotechnology company with a broad pipeline of partnered programs and ongoing collaborations for $43 million in cash. The acquisition of Vernalis provided us with more than eight fully-funded shots on goal, a 70-person research and development team based in Cambridge, England working on a portfolio of collaborations that have the potential to create additional shots on goal, a compound library of unpartnered programs for potential development and out-licensing, and England-based operations that provide a platform to help efficiently pursue investment and acquisition activities in Europe and the United Kingdom.
In December 2018, we announced the acquisition of economic rights to PTX-022 from Palvella for $10 million in cash. We will receive a tiered net sales royalty in the mid-to-upper single digits on any net sales of PTX-022, as well as regulatory and financing milestones. PTX-022 is a novel, orphan-indicated, topical formulation of rapamycin in Phase 2/3 development for the treatment of pachyonychia congenita, a rare skin disorder with no FDA-approved treatment.
In January 2019, we announced an investment in Dianomi, paying a total of $3 million in exchange for a tiered royalty of 2%-3% based on net sales for the first five products to be approved using Dianomi’s patented MCM technology and a loan convertible into $1 million of equity at Dianomi’s next qualified financing.
In March 2018, we announced the signing of a license agreement granting Roivant exclusive global rights to develop and commercialize LGD-6972 (now named RVT-1502), the GRA which we developed through a successful Phase 2 clinical trial. Under the terms of the agreement, we received a $20 million upfront license fee, and are eligible to receive up to an additional $528.8 million of milestone payments and tiered royalties ranging from low double digits to the mid-teens, with the top tier applying to annual net sales above $3 billion. Roivant is responsible for all costs related to the program.
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We expanded the distribution capacity on Captisol. In addition to shipping commercial and clinical material out of our contract manufacturing sites in both Portugal and Ireland last year, we also established a new distribution capability in Ireland in 2018.


Selected Late-Stage Clinical Developments

Retrophin announced that the first patient was dosed in a global, pivotal Phase 3 clinical trial evaluating the long-term nephroprotective potential of sparsentan for the treatment of IgA nephropathy.
Retrophin presented new data examining the long-term effects of sparsentan in FSGS at the American Society of Nephrology Kidney Week 2018, and announced that the Journal of the American Society of Nephrology published online the positive results from Retrophin’s Phase 2 DUET study of sparsentan for the treatment of FSGS.
Retrophin announced that the United States Patent and Trademark Office issued a new patent providing coverage for the use of sparsentan in the treatment of IgAN and broadening the existing coverage to include all doses of sparsentan between 200 and 800 mg/day. The patent has a stated expiration date of March 30, 2030.
Melinta Therapeutics announced positive topline results from its Phase 3 trial of Baxdela™ for the treatment of adult patients with community-acquired bacterial pneumonia.
Viking presented positive results from a 12-week Phase 2 study of VK2809 in patients with non-alcoholic fatty liver disease in an oral late-breaker presentation at the AASLD’s annual meeting in San Francisco, CA.
Viking presented positive results from its Phase 2 study of VK5211 in patients recovering from hip fracture at the American Society for Bone and Mineral Research 2018 annual meeting.
Aldeyra announced enrollment of the first patient in a Phase 3 clinical trial of topical ocular reproxalap for the treatment of allergic conjunctivitis.
Aldeyra also announced that the last patient has been dosed in a Phase 2b clinical trial of topical ocular reproxalap in dry eye disease.
Sermonix announced FDA acceptance of its IND application and the initiation of a 100-patient Phase 2 trial of oral lasofoxifene for the treatment of metastatic breast cancer. Sermonix also announced the presentation of three posters for oral lasofoxifene in metastatic breast cancer at the 2018 San Antonio Breast Cancer Symposium.
Verona announced enrollment of the last patient in its Phase 2 clinical trial evaluating the effect of nebulized ensifentrine (RPL554) as an add-on to dual therapy using long-acting anti-muscarinic / long-acting beta2-agonists and triple therapy in the maintenance treatment of patients with moderate to severe COPD.
Verona announced initiation of a Phase 2 clinical trial to evaluate the pharmacokinetic profile, efficacy and safety of a dry powder inhaler formulation of ensifentrine in patients with moderate-to-severe COPD.
Merrimack announced a poster presentation related to seribantumab at the 2018 ASCO Annual Meeting.
Marinus announced positive results from its Phase 2 clinical trial evaluating ganaxolone IV in women with postpartum depression.
Opthea reported that the last patient was enrolled in its ongoing Phase 2b trial of OPT-302 for wet age-related macular degeneration.

Selected Regulatory Developments

Novartis announced that the FDA expanded the label for Promacta (eltrombopag) to include first-line treatment for adults and pediatric patients two years and older with SAA in combination with standard immunosuppressive therapy.
Novartis announced results of a retrospective, real-world evidence study in patients with ITP treated with Promacta/Revolade (eltrombopag), compared with other second-line therapies, demonstrating that patients experienced better clinical outcomes with Promacta in terms of fewer bleeding episodes.
On October 1, 2018, Amgen announced that the FDA approved the supplemental NDA to expand the prescribing information for Kyprolis to include a once-weekly dosing option in combination with dexamethasone for patients with relapsed or refractory multiple myeloma.
CASI Pharmaceuticals announced that it received National Medical Products Administration (formerly, the China FDA) approval of EVOMELA for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma, and the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
Daiichi Sankyo announced receipt of marketing approval in Japan for MINNEBRO (esaxerenone) for the treatment of hypertension.
SAGE announced that the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted that data support the favorable benefit-risk profile of Zulresso injection for the treatment of postpartum depression. SAGE also announced on November 20, 2018 that the PDUFA action date for the NDA for ZULRESSO is March 19, 2019.

2


Disclosed Licensing Deals Entered into or Expanded

OmniAb Technology

We announced receipt of a $47 million payment as a result of signing an amendment related to our OmniAb platform license agreement with WuXi. Under the amended agreement, we will continue to be eligible to earn royalties at the same rate and terms as the previous agreement and the predefined contract payments have been eliminated. With this new business relationship, WuXi believes it will be able to increase the number of OmniAb antibodies it discovers for its clients in China and around the world.
Worldwide license agreements with venBio Partners, Ferring Pharmaceuticals and Glenmark Pharmaceuticals to use the OmniAb platform technologies to discover fully human antibodies. The agreement with venBio permits the venture capital firm’s portfolio companies to enter into worldwide OmniAb platform agreements under previously agreed-upon terms. We are eligible to receive annual access payments, milestone payments and royalties on future net sales of any antibodies discovered under these licenses.
We entered into OmniChicken license expansions with FivePrime and Amgen, allowing the companies to use the OmniChicken technology.
Worldwide license agreement with iMBP to use the OmniAb platform technologies to discover fully human antibodies. iMBP is an early-stage company with experienced leadership and proprietary research based on functional preservation of key natural enzymes responsible for lipid metabolism. Their discovery-stage programs target obesity and related diseases, with a primary focus on hyperlipidemia. We are eligible to receive a tiered royalty on future sales of up to 6%. As part of the agreement, we will fund and facilitate select early antibody discovery activities, and in return will receive an equity ownership position in iMBP.
OmniAb platform license agreement with Fred Hutch to use the OmniAb rodent platform technologies to discover fully human antibodies. We are eligible to receive a defined share of revenue received by Fred Hutch from companies that commercialize products incorporating any such OmniAb-derived antibody.
Research and development agreement with Janssen Pharmaceuticals for the development by Ligand of a HCO version of OmniChicken, for which we are eligible to earn defined milestone payments. Upon completion of the project, we will be able to make the HCO OmniChicken available to other commercial partners.
 
Captisol Technology

Captisol clinical use license agreements with Sunshine Lake Pharmaceuticals, Merck KGaA and reVision Therapeutics.

Additional Pipeline and Partner Developments

CStone announced two pivotal Phase 2 studies exploring the efficacy and safety of OmniAb-derived CS1001 in patients with natural killer cell/T-cell lymphoma and classical Hodgkin's lymphoma have been initiated and have each enrolled and dosed the first patient.
CStone announced a collaboration agreement with Blueprint Medicines to initiate a proof-of-concept clinical trial in China evaluating BLU-554 in combination with OmniAb-derived CS1001.
CStone also announced the completion of a $260 million series B financing that will primarily fund clinical development of OmniAb-derived CS1001.
Aptevo announced that the first patient was dosed in a Phase 1/1b clinical trial of APVO436, a novel anti-CD123 by anti-CD3 bispecific antibody, which is being developed for the treatment of patients with acute myeloid leukemia and high-grade myelodysplastic syndrome.
Aptevo presented new data for APVO436 at the AACR 2018 Annual Meeting.
Corvus announced updated clinical and biomarker data from its ongoing Phase 1/1b study of CPI-444 in patients with treatment-refractory renal cell carcinoma, which demonstrated an overall survival of 88% at more than 20 months follow-up with CPI-444 administered in combination with atezolizumab.
Corvus announced the publication of results of preclinical studies of CPI-444 demonstrating that it induces dose-dependent antitumor responses as a monotherapy and in combination with anti-PD-1, anti-PD-L1 and anti-CTLA-4 therapies.
On December 3, 2018, Amgen announced the first clinical results from a study evaluating investigational novel BiTE immunotherapy AMG 330. In a Phase 1 dose-escalation study, AMG 330, which targets CD33, provided early evidence of tolerability and anti-tumor activity in patients with relapsed and/or refractory multiple myeloma and relapsed or refractory acute myeloid leukemia.
Seelos closed a reverse merger with Apricus Biosciences and is now publicly traded on the Nasdaq Capital Market under the trading symbol “SEEL”. In conjunction with the reverse merger transaction, Seelos raised gross proceeds of $18 million in a private financing.
3


OmniAb-derived RVT-1401 (previously HL 161) have formed the foundation of a new company called Immunovant during 2018.
Nucorion Pharmaceuticals presented preclinical data for its novel liver-targeting prodrug technology program, CO1010, for the treatment of hepatitis B at the European Association for the Study of the Liver’s International Liver Congress.
Syros Pharmaceuticals announced new preclinical data on SY-1365, its first-in-class selective CDK7 inhibitor, showing that it inhibits tumor cell growth in HR-positive breast cancer cell lines that are resistant to treatment with CDK4/6 inhibitors and that it has synergistic activity in combination with fulvestrant in these treatment-resistant cells.
OmniAb partner Arcus announced that abstracts relating to its portfolio were presented at the Society for Immunotherapy of Cancer Annual Meeting.
Arcus announced that the FDA cleared the IND application for OmniAb-derived AB122 and the company presented a poster on AB122 at the AACR 2018 Annual Meeting.
Arcus also announced a collaboration agreement with Infinity Pharmaceuticals to evaluate AB122 with IPI549, an immuno-oncology candidate that selectively inhibits PI3K-gamma.
MEI Pharma announced a poster presentation related to ME-344 at the 2018 ASCO Annual Meeting.


Internal Pipeline Highlights

We have continued to make progress on our Captisol-enabled (CE) iohexol program, including deepening the preclinical dataset significantly, which is designed to further illustrate the differentiating features of our product. We are in final preparations for making our Clinical Trial Application submission to the health authorities in Canada where our first in-human trial will be run this year. We've manufactured our clinical batches of CE-iohexol and are expecting to initiate the clinical trial this quarter and we plan to have Phase 1 bioavailability data on CE-iohexol in the third quarter of 2019.
We now have five internal antibody-related programs that we initiated in 2018. The programs are focused on targets for which biology is known, centered in the oncology and inflammation therapy areas.

Technologies

A variety of technology platforms that enable elements of drug discovery or development form the basis of our portfolio of fully-funded shots on goal. Platform technologies or individual drugs discovered by Ligand are related to a broad estate of intellectual property that includes over 1,200 patents issued worldwide.

OmniAb Technologies

Our OmniAb technology includes our OmniRat, OmniMouse, OmniFlic and OmniChicken technology platforms for use in discovering fully human antibodies. The OmniRat, OmniMouse, and OmniFlic platforms consist of genetically-engineered transgenic animals that produce a broadly diversified repertoire of antibodies and enable novel fully-human antibody drug discovery and development by our OmniAb partners. Fully-human OmniAb antibodies provide advantages to our partners in that fully-human antibodies have reduced immunogenicity, streamlined development timelines and costs, and accelerated novel antibody discovery. The OmniChicken platform consists of genetically-engineered transgenic chickens which enable the generation of novel antibodies against targets that are not immunogenic in mammals like mice and rats. Currently, more than 40 partners are utilizing OmniAb animals in their drug discovery and development efforts. We acquired these technologies through the acquisition of OMT in January 2016 and Crystal in October 2017.

Vernalis Design Platform (VDP)

The VDP technology leverages our leadership in structure-guided drug discovery in which protein structure, drug fragment screening and modeling are integrated with medicinal chemistry to enable the rapid discovery of novel drugs. The VDP approach establishes structural information via x-ray crystallography and NMR methods and develops reliable assay systems to test biophysical, functional and cellular properties. The VDP has proven success with highly-challenging pharmaceutical targets and has generated a broad portfolio, with over 5,000 novel drug/target complexes determined and over 400 granted and pending patents. We acquired the VDP technology through our acquisition of Vernalis in October of 2018, and maintain state-of-the-art laboratories in Cambridge, UK.

Captisol Technology

Captisol is our patented, uniquely-modified cyclodextrin that is specifically designed to maximize safety, while improving the solubility, stability and bioavailability of APIs. Captisol can enable faster and more efficient development paths for our partners, given its known regulatory acceptance. We maintain both Type IV and Type V DMFs with the FDA. These DMFs contain manufacturing and safety information relating to Captisol that our licensees can reference when developing
4


Captisol-enabled drugs. We also filed a DMF in Japan in 2015. Captisol-enabled drugs are marketed in more than 60 countries, and over 40 partners have Captisol-enabled drugs in development.

LTP Technology Platform

The LTP Technology platform is a novel prodrug technology designed to selectively deliver a broad range of pharmaceutical agents to the liver. A prodrug is a biologically inactive compound that can be metabolized in the body to produce an active drug. The LTP Technology works by chemically modifying biologically active molecules into an inactive prodrug, which will be administered to a patient and later activated by specific enzymes in the liver. The technology can be used to improve the safety and/or activity of existing drugs, develop new agents to treat certain liver-related diseases, and treat diseases caused by imbalances of circulating molecules that are controlled by the liver. The technology is especially applicable to metabolic and cardiovascular indications, among others. Currently 3 programs are utilizing the LTP Technology or related platform(s).

SUREtechnology Platform (owned by Selexis)

We acquired economic rights to over 30 SUREtechnology Platform programs from Selexis in two separate transactions in 2013 and 2015, granting us rights to downstream economics on novel biologics and biosimilars programs. The SUREtechnology Platform, developed and owned by Selexis, is a novel technology that improves the way that cells are utilized in the development and manufacturing of recombinant proteins and drugs. The technology is based on novel DNA-based elements that control the dynamic organization of chromatin within mammalian cells and allow for higher and more stable expression of recombinant proteins. The technology creates advantages over traditional approaches including accelerated development and manufacturing times, high yields and increased compound stability.


5


Partners and Licensees
We currently have partnerships and license agreements with over 110 pharmaceutical and biotechnology companies. In addition to the table below, we also have more than 10 undisclosed partners and licensees.
Big PharmaTickerGenerics Ticker Biotech, continued Ticker 
AbbVie ABBV Alvogen Private Immunovant Private 
AstraZeneca AZN Avion Private J-Pharma Private 
Baxter BAX BioCad Private Marinus MRNS 
Boehringer Ingelheim Private Coherus CHRS MEI MEIP 
BMS BMY Gedeon Richter GEDSF Melinta MLNT 
Daiichi Sankyo DSKY Zydus Cadila CADILAHC Menarini Private 
Eli Lilly LLY Meridian Labs Private 
Eisai 4523 Metavant Private 
GSK GSK BiotechTickerMerrimack MACK 
Janssen JNJ ABBA Private Novogen NVGN 
Merck MRK AiCuris Private Nucorion Private 
Merck KGaA MRK Aldeyra ALDX Opthea OPT 
Novartis NVS Amgen AMGN Outlook OTLK 
Ono 4528 Arcus RCUS Palvella Private 
Otsuka 4768 ARMO Private Phoenix Tissue Private 
Pfizer PFE Asahi Kasei 3407 Precision Biologics Private 
Sanofi SNY Azure Private Retrophin RTRX 
Takeda 4502 bluebird bio BLUE Revision Therapeutics Private 
Cantex Private SAGE SAGE 
Celgene CELG Seattle Genetics SGEN 
Specialty PharmaTickerCorvus CRVS Seelos SEEL 
Achaogen AKAO C-Stone 2616.HK Servier Private 
Aytu Bioscience AYTU CURx Private Sunshine Lake Private 
Aziyo Private Aptevo APVO Symphogen Private 
Beloteca Private Exelixis EXEL Teneobio Private 
CorMatrix Private Five Prime FRPX TG Therapeutics TGTX 
CTI Biopharma CTIC F-Star Private Tizona Private 
Cuda Private Genmab GEN Vaxxas Private 
Ferring Private Genagon Private Vega Private 
Gloria 2437 Genekey Biotech Private VentiRx Private 
Lundbeck LUN Glenmark GLENMARK Verona VRNA 
Sedor Private Gilead Sciences GILD Vertex VRTX 
Sermonix Private HanAll 9420 Viking VKTX 
Shire SHPG Harbour Private Xi'an Xintong Private 
Spectrum SPPI iMetabolic Private XTL Bio XTLB 
Teijin TINLF WuXi Private 
Vireo Health Private 
Upsher-Smith Private 
6


Portfolio
We have a large portfolio of current and future potential revenue-generating programs, including over 200 fully-funded by our partners. In addition to the table below, we also have more than 60 undisclosed programs.
Approved
Blood DisordersCardiovascularCNS
NovartisPromactaBaxterNexterone LundbeckCarnexiv
Exelixis/Daiichi-SankyoMinnebroMenariniFrovatriptan
CancerMedical Device/Cardiology
AmgenKyprolisZydus CadilaVivitraAziyo Base BusinessAziyo
SpectrumEvomelaZydus CadilaBryxta
 
Infectious DiseaseInflammatory/Metabolic
AlvogenVoriconazoleAytuTuzistraBiocadInterferon beta-1a
MelintaBaxdelaPfizerViviant/Conbriza
HikmaVoriconazolePar PharmaceuticalsPosaconazolePfizerDuavee
MerckNoxafil-IVPfizerVfend-IVZydus CadilaExemptia
Phase 3 or Regulatory Submission Stage
Blood DisordersSevere and RareInflammatory/Metabolic
BiocadBCD-066RetrophinSparsentanCoherusCHS-0214
BioverativSutimlimab
  
CancerCNS
OncobiologicsONS-3010TakedaPevonedistatSAGEBrexanolone
OncobiologicsONS-1045SedorCE-Fosphenytoin
Sunshine LakeVilazodone
Other / Undisclosed
Aldeyra TherapeuticsReproxalap
Phase 2
Blood DisordersInfectious DiseaseCNS
NovartisKLM465GileadGS-5734CurXIV Topiramate
Xi'an XintongPradefovirMarinus PharmaGanaxalone IV
SeelosAplindore
Cancer
C-StoneCS1001Eli LillyMerestinibJ-PharmaJPH-203
CantexCX-01Eli LillyPrexasertibPrecision BiologicsNPC-1C
CTI BiopharmaTosedostatGloriaGLS010VentiRx PharmaVTX-2337
SermonixLasofoxifene
CardiovascularOther / UndisclosedSevere and Rare
Cardioxyl / BMSBMS986231Opthea LtdOPT-302Palvella PTX-022
XTL BiohCDR1
Inflammatory and Metabolic
AzureLasofoxifeneVeronaEnsifentrine
MetavantRT-1502VikingVK5211
NovartisECF843VikingVK2809/VK0214
SedorCE-BudesonideVikingVK0612

7


Phase 1
Cancer
AmgenAMG-330IBC GeneriumDepleraServierS55746/S64315
AptevoAPVO436JanssenJNJ64007957SymphogenSYM022
ArcusAB122MEI PharmaME-344SymphogenSYM023
CorvusCPI-444MeridianML-061Upsher-SmithCXCR4
F-StarFS-102NovartisMIK-665VentiRx PharmaVTX-1463
Gedeon RichterBevacizumabNovartisBCL-201Xi'an XintongMB07133
Infectious DiseaseSevere and RareOther / Undisclosed
VaxxasNanopatchIBC GeneriumGNR-008Phoenix TissuePTR-01
TakedaTAK-925
Inflammatory and Metabolic
Gedeon RichterRGB-03HanAll/HarbourHL161
Genekey BiotechPCSK-9ImmunovantRVT-1401
TakedaTAK-020

Pre-Clinical
Other / Undisclosed
ABBAOmniAb ElectraOmniAb Ono PharmaceuticalsOmniAb
AbbVieOmniAb F-StarOmniAb PfizerOmniAb
AchaogenOmniAbFerringOmniAbRevision TherapeuticsCvZ001
AmgenOmniAbFred HutchinsonOmniAbSeattle GeneticsOmniAb
ARMO BiosciencesOmniAbGenmabOmniAbSymphogenOmniAb
AvionCE programsGileadCE-programTeneobioOmniAb
BelotecaCE-ZiprasidoneGlenmarkOmniAbTevaOmniAb
Boehringer IngelheimOmniAbHanAllOmniAbTizonaOmniAb
CelgeneOmniAbiMetabolicOmniAbVegaOmniAb
CelgeneVipadenantJanssenOmniAbVenBioOmniAb
CovagenOmniAbKSQ TherapeuticsOmniAbWuxiOmniAb
Five PrimeOmniAbMerck KGaAOmniAb
Inflammatory and Metabolic
SedorCE-MeloxicamSeelosSLS-010Vireo HealthCE-Cannabinoids
SeelosSLS-008VikingDGAT-1 Inhibitor
Infectious DiseaseCNS
NucorionNUC-101CudaCudafolSAGESAGE-689
NucorionNUC-202CURx PharmaIV LamotrigineSeelosSLS-012
CancerBlood DisordersMedical Device/Cardiology
NucorionNUC-404VikingEPOR AgonistCorMatrixCorMatrix Pipeline
OncobiologicsRituximab
OncobiologicsONS-1050
TG TherapeuticsIRAK4

8


Selected Commercial Programs
We have multiple programs under license with other companies that have products that are already being commercialized. The following programs represent components of our current portfolio of revenue-generating assets and potential for near-term growth in royalty and other revenue. For information about the royalties owed to us for these programs, see “Royalties” later in this business section.
Promacta (Novartis)
We are party to a license agreement with Novartis related to Promacta, which is an oral medicine that increases the number of platelets in the blood. Platelets are one of the three components of blood and facilitate clotting in the blood. Individuals with low platelets can be at significant risk of bleeding or death. Because of the importance of having a sufficient number of platelets, Promacta has broad potential applicability to a number of medical situations where low platelets exist.

Promacta is currently approved for four indications: (1) the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy; (2) thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy; (3) in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with SAA; and (4) patients with SAA who have had an insufficient response to immunosuppressive therapy. Promacta was initially approved in 2008, and the product has been generating royalty revenue for Ligand since 2009. Promacta is known as Revolade in the EU and other non-US markets.
Novartis has been and continues to pursue globalization of the brand and currently markets Promacta in multiple countries for the approved indications. Specifically, Promacta is currently approved for ITP in more than 100 countries, for the Hepatitis C-related indication in more than 50 countries, and for post-immunosuppressive therapy SAA indication in more than 45 counties. Approval of Promacta in the U.S. for the first-line treatment of SAA was obtained in November of 2018.
Beyond the currently-approved indications, Novartis has also disclosed that is performing or supporting development activities to expand the brand into new indications, including as a counter measure for the hematopoietic effects of acute radiation syndrome (H-ARS), and has been granted FDA Breakthrough Therapy designation. As of January 2019, there are 46 open clinical trials related to Promacta (listed as recruiting or open, and not yet recruiting) on the clinicaltrials.gov website.
Promacta (Novartis)
< $100 million4.7%  
$100 to $200 million6.6%  
$200 to $400 million7.5%  
$400 million to $1.5 billion9.4%  
>$1.5 billion9.3%  
We are entitled to receive royalties related to Promacta during the life of the relevant patents or following patent expiry, at a reduced rate for ten years from the first commercial sale, whichever is longer, on a country-by-country basis. Novartis has listed a patent in the FDA’s Orange Book for Promacta with an expiration date in 2028, and absent early termination for bankruptcy or material breach, the term of the agreement expires upon expiration of the obligation to pay royalties. There are no remaining milestones to be paid under the agreement.

9


Kyprolis (Amgen)

Ligand supplies Captisol to Amgen for use with Kyprolis, and granted Amgen an exclusive product-specific license under our patent rights with respect to Captisol. Kyprolis is formulated with Ligand’s Captisol technology and is approved in the United States for the following:

In combination with dexamethasone or combination with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
Kyprolis is also approved in multiple countries outside the U.S. and Amgen continues to invest significantly in Kyprolis to further expand its label and geography. Amgen’s obligation to pay royalties does not expire until four years after the expiration of the last-to-expire patent covering Captisol. Our patents and applications relating to the Captisol component of Kyprolis are not expected to expire until 2033.
Kyprolis (Amgen)
< $250 million1.5%  
$250 to $500 million2.0%  
$500 to $750 million2.5%  
>$750 million3.0%  
Our agreement with Amgen may be terminated by either party in the event of material breach or bankruptcy, or unilaterally by Amgen with prior written notice, subject to certain surviving obligations. Absent early termination, the agreement will terminate upon expiration of the obligation to pay royalties. Under this agreement, we are entitled to receive remaining milestones of up to $1 million, revenue from clinical and commercial Captisol material sales and royalties on annual net sales of Kyprolis.

Evomela (Spectrum and CASI)

Ligand supplies Captisol to Spectrum for use with Evomela, which is a Captisol-enabled melphalan IV formulation. The FDA approved Evomela for use in two indications:
A high-dose conditioning treatment prior to ASCT in patients with multiple myeloma
For the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

Evomela has been granted Orphan Designation by the FDA for use as a high-dose conditioning regimen for patients with multiple myeloma undergoing ASCT. The Evomela formulation avoids the use of propylene glycol, which has been reported to cause renal and cardiac side-effects that limit the ability to deliver higher quantities of therapeutic compounds. The use of the Captisol technology to reformulate melphalan is anticipated to allow for longer administration durations and slower infusion rates, potentially enabling clinicians to safely achieve a higher dose intensity of pre-transplant chemotherapy.
Under the terms of the license agreement, we granted an exclusive license to Spectrum under our patent rights to Captisol relating to the product. We are eligible to receive over $50 million in potential milestone payments under this agreement and royalties on global net sales of the Captisol-enabled melphalan product. Spectrum’s obligation to pay royalties will expire at the end of the life of the relevant patents or when a competing product is launched, whichever is earlier, but in no event within ten years of the commercial launch. Our patents and applications relating to the Captisol component of melphalan are not expected to expire until 2033. Absent early termination, the agreement will terminate upon expiration of the obligation to pay royalties. The agreement may be terminated by either party for an uncured material breach or unilaterally by Spectrum by prior written notice.
Spectrum sub-licensed Evomela rights for Greater China to CASI in 2014. In December 2018, CASI announced China marketing approval of Evomela and a plan to launch the drug in China in 2019.
On January 17, 2019, Spectrum announced that they entered into a definitive agreement to sell its portfolio of seven FDA-approved hematology/oncology products including Evomela to Arotech Biopharma L.L.C..

Baxdela IV (Melinta)
Melinta’s Baxdela IV is a Captisol-enabled delafloxacin-IV that was approved by the FDA in June 2017 for the treatment of acute bacterial skin and skin structure infections. Delafloxacin is a novel hospital-focused fluoroquinolone antibiotic with activity against a variety of disease-causing bacteria-gram-positives, gram-negatives, atypicals and anaerobes, including quinolone-resistant MRSA. Under the terms of the agreement, we may be entitled to regulatory milestones, as well as a royalty on potential future sales by Melinta, and revenue from Captisol material sales.
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Nexterone (Baxter)
We have a license agreement with Baxter, related to Baxter's Nexterone, a Captisol-enabled formulation of amiodarone, which is marketed in the United States and Canada. We supply Captisol to Baxter for use in accordance with the terms of the license agreement under a separate supply agreement. Under the terms of the license agreement we will continue to earn milestone payments, royalties, and revenue from Captisol material sales. We are entitled to earn royalties on sales of Nexterone through early 2033.
Noxafil-IV (Merck)
We have a supply agreement with Merck related to Merck’s NOXAFIL-IV, a Captisol-enabled formulation of posaconazole for IV use. NOXAFIL-IV is marketed in the United States, EU and Canada. We receive our commercial compensation for this program through the sale of Captisol, and we do not receive a royalty on this program.
Duavee or Duavive (bazedoxifene/conjugated estrogens) and Viviant/Conbriza (Pfizer)
Pfizer is marketing bazedoxifene under the brand names Viviant and Conbriza in various territories for the treatment of postmenopausal osteoporosis. Pfizer is responsible for the marketing of bazedoxifene, a synthetic drug specifically designed to reduce the risk of osteoporotic fractures while also protecting uterine tissue. Pfizer has combined bazedoxifene with the active ingredient in Premarin to create a combination therapy for the treatment of post-menopausal symptoms in women. Pfizer is marketing the combination treatment under the brand names Duavee and Duavive in various territories. Net royalties on annual net sales of Viviant/Conbriza and Duavee/Duavive are each payable to us through the life of the relevant patents or ten years from the first commercial sale, whichever is longer, on a country by country basis.
Aziyo Portfolio (Aziyo)
We receive a share of revenue from the currently marketed Aziyo portfolio of commercial pericardial repair and CanGaroo® Envelope ECM products. In addition, Ligand has the potential to receive a share of revenue and potential milestones from the currently marketed CanGaroo® ECM Envelope for cardiac implantable electronic devices. Aziyo’s products are medical devices that are designed to permit the development and regrowth of human tissue.
Exemptia, Vivitra and Bryxta (Zydus Cadila)
Zydus Cadila’s Exemptia (adalimumab biosimilar) is marketed in India for autoimmune diseases. Zydus Cadila uses the Selexis technology platform for Exemptia. We are entitled to earn royalties on sales by Zydus Cadila for ten years following the first commercial sale.
Zydus Cadila’s Vivitra (trastuzumab biosimilar) is marketed in India for breast cancer. Zydus Cadila uses the Selexis technology platform for Vivitra. We are entitled to earn royalties on sales by Zydus Cadila for ten years following the first commercial sale.
Zydus Cadila’s Bryxta (bevacizumab biosimilar) is marketed in India for non-small cell lung cancer. Zydus Cadila uses the Selexis technology platform for Bryxta. We are entitled to earn royalties on sales by Zydus Cadila for ten years following the first commercial sale.
Minnebro (Exelixis)

Daiichi Sankyo announced on January 8, 2019 the receipt of marketing approval in Japan for MINNEBRO Tablets (esaxerenone) for the treatment of hypertension. Our partner, Exelixis, entered into a collaboration agreement with Daiichi Sankyo for the development of esaxerenone, a mineralocorticoid receptor antagonist. Under the terms of the agreement with Exelixis, we are entitled to receive a royalty on future sales.

Summary of Selected Development Stage Programs
We have multiple fully-funded partnered programs that are either in or nearing the regulatory approval process, or given the area of research or value of the license terms we consider particularly noteworthy. We are eligible to receive milestone payments and royalties on these programs. This list does not include all of our partnered programs. For information about the royalties owed to Ligand for these programs, see “Royalties” later in this business section. In the case of Captisol-related programs, we are also eligible to receive revenue for the sale of Captisol material supply.
11


Zulresso-SAGE-547 (SAGE)
Our partner, SAGE, is developing novel medicines to treat life altering central nervous system disorders. SAGE filed an NDA with the FDA in 2018, seeking approval to market and sell Zulresso for the treatment of postpartum depression, or PPD. The NDA is currently under FDA review with a PDUFA date of March 19, 2019. We have the potential to receive milestone payments, royalties and revenue from Captisol material sales for Captisol-enabled programs. SAGE is responsible for all development costs related to the program.
Sparsentan (Retrophin)
Our partner, Retrophin, is developing sparsentan for orphan indications of severe kidney diseases, and has initiated a global pivotal Phase 3 clinical trial to enable an NDA filing for sparsentan for the treatment of FSGS. Additionally, Retrophin initiated a global pivotal Phase 3 clinical trial evaluating the long-term nephroprotective potential of sparsentan for the treatment of IgA nephropathy, a rare, immune complex mediated chronic glomerular disease. Certain patient groups with severely compromised renal function, including those with FSGS and IgA nephropathy, exhibit extreme proteinuria resulting in progression to dialysis and a high mortality rate. Sparsentan, with its unique dual blockade of angiotensin and endothelin receptors, is expected to provide meaningful clinical benefits in mitigating proteinuria in indications where there are no approved therapies.
Under our license agreement with Retrophin, we are entitled to receive potential net milestones of over $70 million and net royalties on future worldwide sales by Retrophin. The royalty term is expected to be 10 years following the first commercial sale. Retrophin is responsible for all development costs related to the program.
Prexasertib- LY2606368 (Eli Lilly)
Our partner, Eli Lilly is conducting Phase 2 clinical trials for prexasertib (Captisol-enabled LY2606368), a checkpoint kinase 1/2, or Chk 1/2, inhibitor for the treatment of solid tumors. Under the terms of the agreement, we may be entitled to regulatory milestones, royalties on potential future sales by Eli Lilly and revenue from Captisol material sales.
BMS-986231 (formerly CXL-1427) (BMS)
Our partner, BMS, is conducting Phase 2 clinical trials for a Captisol-enabled second-generation prodrug that chemically breaks down to produce HNO and an inactive byproduct. HNO is thought to have a dual mode of action, by improving cardiac function and acting as a vasodilator for treating ADHF. Under the terms of the agreement, we may be entitled to development and regulatory milestones, and royalties on potential future sales by BMS and revenue from Captisol material sales.
RVT-1502 (formerly LGD-6972) (Metavant)
Our partner, Metavant, an affiliate of Roivant, is developing RVT-1502, a GRA, which we licensed to Roivant in March 2018. In September 2017, we announced positive results from a Phase 2 clinical study evaluating the efficacy and safety of the compound (formerly known as LGD-6972), as an adjunct to diet and exercise, in subjects with type 2 diabetes mellitis inadequately controlled on metformin monotherapy. Roivant formed Metavant to pursue the development of RVT-1502 and other treatments for cardiometabolic diseases. We are entitled to potential development and regulatory milestones and royalties on potential future sales.

RVT-1401/HL161 (Immunovant, HanAll and Harbour)
Our partner, HanAll has granted Immunovant an exclusive license for the development, manufacture and marketing of RVT-1401 (HL161, an anti-FcRn antibody) for the treatment of pathogenic IgG-mediated autoimmune diseases in the U.S., Canada, Mexico, the EU, the United Kingdom, Switzerland, Latin America, the Middle East and North Africa. Immunovant is currently conducting a Phase 1 clinical trial in healthy volunteers with plans to initiate Phase 2 studies in early 2019 in myasthenia gravis and other inflammatory diseases. Additionally, HanAll and Harbour BioMed, are collaborating to develop HL161 for similar treatment in China and Korea. HanAll retains the rights to HL161 in Korea and Harbour will control the marketing in China. As part of our agreement with HanAll, we are entitled to development and regulatory milestones and royalties on potential future sales from HanAll and sublicense revenues from Immunovant and Harbour based on amounts received by HanAll.
12


TR-Beta - VK2809 and VK0214 (Viking)
Viking is developing VK2809, a novel selective TR-Beta agonist with potential in multiple indications, including hypercholesterolemia, dyslipidemia and NASH. Viking announced positive results from its Phase 2 trial for VK2809 in hypercholesterolemia and fatty liver disease. Viking has also been granted orphan drug status by the FDA for the development of VK0214 for treatment of X-ALD. Under the terms of the agreement with Viking, we may be entitled to up to $375 million of development, regulatory and commercial milestones and tiered royalties on potential future sales. Our TR Beta programs partnered with Viking are subject to CVR sharing and a portion of the cash received will be paid out to CVR holders.
TR-Beta - VK2809 and VK0214 (Viking)
< $500 million3.5%  
$500 to $750 million5.5%  
>$750 million7.5%  

SARM - VK5211 (Viking)
Our partner, Viking, is developing VK5211, a novel, potentially best-in-class SARM for patients recovering from hip-fracture. SARMs retain the beneficial properties of androgens without undesired side-effects of steroids or other less selective androgens. Viking announced positive results from its Phase 2 trial in patients who suffered hip fracture in the fourth quarter of 2017. Under the terms of the agreement with Viking, we may be entitled to up to $270 million of development, regulatory and commercial milestones as well as tiered royalties on potential future sales.
SARM - VK5211 (Viking)
< $500 million7.25%  
$500 to $750 million8.25%  
>$750 million9.25%  

Lasofoxifene (Sermonix and Azure)
Lasofoxifene is a selective estrogen receptor modulator for osteoporosis treatment and other diseases, discovered through the research collaboration between us and Pfizer. Under the terms of the license agreement with Azure, we retained the rights to the oral formulation of lasofoxifene originally developed by Pfizer.
Our partner, Sermonix has a license for the development of oral lasofoxifene for the United States and additional territories. Under the terms of the agreement, we are entitled to receive over $45 million in potential regulatory and commercial milestone payments as well as royalties on future net sales.
Our partner Azure is developing a novel formulation of lasofoxifene targeting an underserved market in women’s health. Under the terms of our agreement with Azure, we are entitled to receive up to $2.6 million in potential development and regulatory milestones as well as royalties on future net sales through the later of the life of the relevant patents (currently expected to be at least until 2027) or 10 years after regulatory approval. Azure may terminate the license agreement at any time upon six months’ prior notice.
Merestinib- LY2801653 (Eli Lilly)
Our partner, Eli Lilly is conducting Phase 2 clinical trials for Captisol-enabled merestinib (formerly known as LY2801653), a c-Met inhibitor for treatment of cancer. Under the terms of the agreement, we may be entitled to regulatory milestones, royalties on potential future sales by Eli Lilly and revenue from Captisol material sales.
Pevonedistat - TAK-924 (Millennium/Takeda)
Our partner, Millennium/Takeda is currently conducting Phase 3 trials for the development of pevonedistat for the treatment of hematological malignancies and solid tumors. Pevonedistat is a Captisol-enabled Nedd8-Activating Enzyme Inhibitor. Under the terms of the clinical-stage agreement, we may be entitled to development milestones from Millennium/Takeda and revenue from Captisol material sales.
JNJ64007957 (Janssen)

Our partner, Janssen, is developing JNJ64007957, a BCMAxCD3 bispecific antibody discovered in part with the OmniAb platform technology. Janssen is currently conducting a Phase I trial for cancer therapy. We are entitled to earn milestones based on the development of JNJ64007957.
13


AMG-330 (Amgen)
Our licensee, Amgen, is developing AMG 330, a bispecific T-cell engager (BiTE) antibody targeting CD33 and CD3, for use in humans for a wide variety of therapeutic indications. Under the terms of the agreement, we are entitled to milestones and royalties on future sales of AMG 330 formulated with Captisol.
Ganaxalone IV (Marinus)
Our partner, Marinus, is conducting Phase 2 clinical trials with Captisol-enabled ganaxolone IV in patients with PPD and refractory status epilepticus. Marinus has exclusive worldwide rights to Captisol-enabled ganaxolone, a GABAA receptor modulator, for use in humans. We are entitled to development and regulatory milestones, royalties on potential future sales and revenue from Captisol material sales.
APVO436 (Aptevo)
Our partner, Aptevo, is currently conducting a Phase 1 trial of APVO436 for the treatment of acute myeloid leukemia. There is a high unmet medical need for targeted immunotherapies such as APVO436, that can potentially treat patients with relapsed or refractory disease, or patients who cannot tolerate traditional chemotherapy. Under the terms of the agreement with Aptevo, we are entitled to milestones and royalties on future sales.
WuXi Partnership
Pursuant to the WuXi Agreement, we have granted WuXi a non-exclusive license to use our OmniRat, OmniMouse and OmniFlic platforms solely to research, develop and make antibodies, and we have agreed to use commercially reasonable efforts to deliver to WuXi animals from such platforms on a purchase order basis to support WuXi’s licensing rights under the WuXi Agreement. Further, WuXi has the right to out-license antibodies it discovers (whether for itself or at the direction of out-licensees) under the WuXi Agreement to out-licensees worldwide. We are entitled to royalties in the low single digits on net sales of products. Unless earlier terminated, the term of the WuXi Agreement shall continue indefinitely. Either party may terminate the WuXi Agreement upon specified notice of the other party's uncured material breach of the WuXi Agreement. In addition, we have the right to terminate the WuXi Agreement if WuXi or one of its out-licensees challenges the validity of one of our patents covering the platform and WuXi has the right to terminate the WuXi Agreement for convenience following a specified period after notice of termination.
In addition to other earlier stage programs, the following programs have been licensed pursuant to the WuXi Agreement:
AB122/GLS010 (Arcus and Gloria)
Our partner, WuXi, has outlicensed the rights to certain programs using the OmniAb technology to Arcus and Gloria. Arcus, is currently conducting a Phase 1 trial to evaluate the safety and tolerability of AB122 in subjects with advanced solid tumors. Additionally, Gloria, is conducting a Phase 2 trial in China to evaluate the efficacy and safety of GLS-010 injection in the treatment of recurrent or refractory classical Hodgkin’s lymphoma. Under the terms of our agreement with WuXi, we are entitled to royalties on potential future sales.
CS1001 (C-Stone)
Our partner, WuXi, has outlicensed the rights to certain programs using the OmniAb technology to C-Stone. C-Stone, is currently conducting a Phase 2 trial to evaluate the efficacy and safety of CS1001 to treat patients with natural killer cell/T-cell lymphoma and classical Hodgkin’s lymphoma. Under the terms of our agreement with WuXi, we are entitled to royalties on potential future sales.
CPI-444 (Corvus)
Our partner, Corvus, is currently conducting a Phase 1b/2 clinical trial in patients with renal cell carcinoma to evaluate CPI-444, an antagonist of adenosine A2A, in combination with the immunotherapy drug atezolizumab. CPI-444 is also being evaluated in a Phase 1b/2 trial in combination with atezolizumab in patients with non-small cell lung cancer who have failed no more than two prior regimens. Under the terms of our agreement with Corvus, we are entitled to development and regulatory milestones and tiered royalties on potential future sales. The aggregate potential milestone payments from Corvus are approximately $220 million for all indications.
14


Ensifentrine – RPL554 (Verona)
Our partner, Verona, is currently conducting a comprehensive Phase 2 clinical trial for the development of ensifentrine as a maintenance treatment of COPD with nebulized and inhaled formulations. Verona has also completed a positive Phase 2a study evaluating ensifentrine as a treatment for cystic fibrosis. Under the terms of our agreement with Verona, we are entitled to development and regulatory milestones, including a £5.0 million payment upon the first approval of any regulatory authority, and royalties on potential future sales.

ECF843 (Novartis)
Novartis is developing ECF843 for the treatment of dry-eye and other ophthalmic indications. ECF843 has been tested in a Phase 2 trial demonstrating the primary endpoint was met. Novartis uses the Selexis technology platform for ECF843. Under the terms of our agreement with Novartis, we are entitled to development and regulatory milestones and royalties on potential future sales.
Royalties
We have multiple programs under license with other companies that have products that are already being commercialized. In addition to the table below, we have generally described a typical Captisol and OmniAb royalty arrangement as low- to mid-single digit royalties. The following table represents substantially all of the disclosed information about our royalty arrangements:

Royalty Table
Ligand Licenses With Tiered Royalties* 
Program Licensee Royalty Rate 
Duavee Pfizer 0.5% - 2.5% 
Viviant/Conbriza Pfizer 0.5% - 2.5% 
CE-Lamotrigine CURx 4.0% - 7.0% 
CE-Topiramate CURx 6.0% - 7.5% 
CE-Budesonide Sedor 8.0% - 10.0% 
CE-Meloxicam Sedor 8.0% - 10.0% 
IRAK4 TG Therapeutics 6.0% - 9.5% 
Lasofoxifene Sermonix 6.0% - 10.0% 
FBPase Inhibitor (VK0612) Viking 7.5% - 9.5% 
SARM (VK5211) Viking 7.25% - 9.25% 
TR Beta (VK2809 and VK0214) Viking 3.5% - 7.5% 
Oral EPO Viking 4.5% - 8.5% 
DGAT-1 Viking 3.0% - 7.0% 
Various Nucorion 4.0% - 9.0% 
Various Seelos 4.0% - 10.0% 
OmniAb-iMetabolic iMetabolic <6% 
OmniAb-Genagon Genagon 4.0% - 6.0% 
Mineral Coated Microparticle technology Dianomi 2.0% - 3.0% 
PTX-022 Palvella 5.0% - 9.8% 
RVT-1502 Metavant Low double digit to mid-teen royalty 
CPI-444 Corvus Mid single digit to low-teen royalty 
Ensifentrine (RPL554) Verona Low to mid-single digit royalty 

15


Ligand Licenses With Fixed Royalties*
ProgramLicenseeRoyalty Rate
EvomelaSpectrum Pharma20%  
BaxdelaMelinta2.5%  
Brexalalone (SAGE-547)SAGE3%  
SparsentanRetrophin9%  
CE-FosphenytoinSedor11%  
PradefovirXi'an Xintong9%  
MB07133Xi'an Xintong6%  
KLM465Novartis14.5% (6.5% in year one)  
Topical lasofoxifeneAzure Biotech5%  
MM-121Merrimack Pharma<1.0%  
MM-141Merrimack Pharma<1.0%  
ME-143MEI PharmaLow single digit royalty  
ME-344MEI PharmaLow single digit royalty  
ReproxalapAldeyra TherapeuticsLow single digit royalty  
PCSK-9GenekeyLow single digit royalty  
CS1001C-StoneLow single digit royalty  
VariousGloriaLow single digit royalty  
4-1BBZhilkang HongyiLow single digit royalty  
AB122ArcusLow single digit royalty  
OmniAb-KSQ TherapeuticsKSQ TherapeuticsSingle digit royalty  

*Royalty rates are shown net of sublicense payments. Royalty tier references for specific rates notated in the table are for up to and including the dollar amount referenced. Higher tiers are only applicable for the dollar ranges specified in the table.

Contract Payments (Milestones)
Many of our programs under license with our partners will generate contract payments to us if our partners reach certain development, regulatory and commercial milestones. The following table represents the potential maximum value of our contract payment pipeline on milestones by development stage, technology and partner (in thousands):
Technology* Stage* Partner* 
OmniAb > $825,000 Preclinical > $40,000 Viking $1,500,000 
Captisol > $175,000 Clinical > $500,000 Metavant $528,750 
Vernalis > $250,000 Regulatory > $1,000,000 Janssen $245,400 
LTP/Hep Direct > $250,000 Commercial > $1,660,000 Seelos $141,800 
NCE/Other > $2,000,000 Other > $300,000 Retrophin $100,750 
Total > $3,500,000 Total > $3,500,000 Corvus (Oncology) $91,500 
Xi'an Xintong $43,125 
Other > $848,675 
Total > $3,500,000 
*All tables exclude our annual access fees and collaboration revenue for development work.
Internal Development Programs 
We have a number of internal development programs focused on a wide-range of indications. Our primary research and development efforts are led by our teams in Emeryville, California and Cambridge, England. The following table represents internal programs eligible for further development or partnership:
16


Program Development Stage Indication 
Luminespib/Hsp90 InhibitorPhase 2Oncology
FAAH InhibitorPhase 1Pain
CE-Sertraline, Oral ConcentratePhase 1Depression
CE-IohexolPhase 1Diagnostics
CCR1 AntagonistPreclinicalOncology
CE-BusulfanPreclinicalOncology
CE-Cetirizine InjectionPreclinicalAllergy
CE-Silymarin for Topical formulationPreclinicalSun damage
FLT3 Kinase InhibitorsPreclinicalOncology
GCSF Receptor AgonistPreclinicalBlood disorders
Liver Specific Glucokinase ActivatorPreclinicalDiabetes
Omnichicken derived antibodies (5 programs)DiscoveryMultiple
Chk1 InhibitorPreclinicalOncology
Manufacturing
We contract with a third party manufacturer, Hovione, for Captisol production. Hovione is a global supplier with over 50 years of experience in the development and manufacture of APIs and Drug Product Intermediates. Hovione operates FDA-inspected sites in the United States, Macau, Ireland and Portugal. Manufacturing operations for Captisol are currently performed at two sites, in both of Hovione's Portugal and Ireland facilities with distribution operations also performed from Hovione's Portugal and Ireland sites. Additionally, we also store and distribute Captisol from a subterranean warehouse controlled by us and located in Kansas. We believe we maintain adequate inventory of Captisol to meet our current and future partner needs.
In the event of a Captisol supply interruption, we are permitted to designate and, with Hovione’s assistance, qualify one or more alternate suppliers. If the supply interruption continues beyond a designated period, we may terminate the agreement. In addition, if Hovione cannot supply our requirements of Captisol due to an uncured force majeure event, we may also obtain Captisol from a third party and have previously identified such parties.
The current term of the agreement with Hovione is through December 2024. The agreement will automatically renew for successive two year renewal terms unless either party gives written notice of its intention to terminate the agreement no less than two years prior to the expiration of the initial term or renewal term. In addition, either party may terminate the agreement for the uncured material breach or bankruptcy of the other party or an extended force majeure event. We may terminate the agreement for extended supply interruption, regulatory action related to Captisol or other specified events. We have ongoing minimum purchase commitments under the agreement.

For further discussion of these items, see below under “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
Competition
Some of the drugs we and our licensees and partners are developing may compete with existing therapies or other drugs in development by other companies. Furthermore, academic institutions, government agencies and other public and private organizations conducting research may seek patent protection with respect to potentially competing products or technologies and may establish collaborative arrangements with our competitors.
Our Captisol business may face competition from other suppliers of similar cyclodextrin excipients or other technologies that are aimed to increase solubility or stability of APIs. Our OmniAb antibody technology faces competition from suppliers of other transgenic animal systems that are also available for antibody drug discovery.
Our competitive position also depends upon our ability to obtain patent protection or otherwise develop proprietary products or processes. For a discussion of the risks associated with competition, see below under “Item 1A. Risk Factors.”
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Government Regulation
The research and development, manufacturing and marketing of pharmaceutical products are subject to regulation by numerous governmental authorities in the United States and other countries. We and our partners, depending on specific activities performed, are subject to these regulations. In the United States, pharmaceuticals are subject to regulation by both federal and various state authorities, including the FDA. The Federal Food, Drug and Cosmetic Act and the Public Health Service Act govern the testing, manufacture, safety, efficacy, labeling, storage, record keeping, approval, advertising and promotion of pharmaceutical products and there are often comparable regulations that apply at the state level. There are similar regulations in other countries as well. For both currently marketed and products in development, failure to comply with applicable regulatory requirements can, among other things, result in delays, the suspension of regulatory approvals, as well as possible civil and criminal sanctions. In addition, changes in existing regulations could have a material adverse effect on us or our partners. For a discussion of the risks associated with government regulations, see below under “Item 1A. Risk Factors.”
Patents and Proprietary Rights

We believe that patents and other proprietary rights are important to our business. Our policy is to file patent applications to protect technology, inventions and improvements to our inventions that are considered important to the development of our business. We also rely upon trade secrets, know-how, continuing technological innovations and licensing opportunities to develop and maintain our competitive position.

Patents are issued or pending for the following key products or product families. The scope and type of patent protection provided by each patent family is defined by the claims in the various patents. The nominal patent expiration dates have been provided. The actual patent term may vary by jurisdiction and depend on a number of factors including potential patent term adjustments, patent term extensions, and terminal disclaimers. For each product or product family, the patents and/or applications referred to are in force in at least the United States, and for most products and product families, the patents and/or applications are also in force in European jurisdictions, Japan and other jurisdictions.

Promacta

Patents covering Promacta are owned by Novartis. The United States patent listed in the FDA’s Orange Book relating to Promacta with the latest expiration date is not expected to expire until 2027. Six months of additional exclusivity to each of the U.S. expiration dates listed in the table has been granted due to pediatric studies conducted by GlaxoSmithKline plc (NYSE:GSK), thereby taking the latest expiration date into 2028. The type of patent protection (e.g., composition of matter or use) and the expiration date for each unexpired patent listed in the Orange Book are provided in the following table. In addition, certain related patents in the commercially important jurisdictions of Europe and Japan are identified in the following table.

Promacta 
United States Corresponding Foreign 
Type of Protection U.S. Patent No. U.S. Expiration Date Jurisdiction Patent Number Expiration Date‡ 
CoM / Use 7,160,870 11/20/2022 EU 1,864,981 5/24/2021 
EU 1,889,838 5/24/2021 
EU 1,294,378 3/14/2025* 
Japan 3,813,875 5/24/2021 
Japan 4,546,919 5/24/2021 
Use 7,332,481 5/24/2021 EU 1,294,378 3/14/2025* 
EU 1,864,981 5/24/2021 
EU 1,889,838 5/24/2021 
Japan 3,813,875 5/24/2021 
Japan 4,546,919 5/24/2021 
CoM / Use 7,452,874 5/24/2021 EU 1,864,981 5/24/2021 
EU 1,889,838 5/24/2021 
Japan 3,813,875 5/24/2021 
Japan 4,546,919 5/24/2021 
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CoM / Use 7,473,686 5/24/2021 EU 1,864,981 5/24/2021 
EU 1,294,378 3/14/2025* 
EU 1,889,838 5/24/2021 
Japan 3,813,875 5/24/2021 
Japan 4,546,919 5/24/2021 
CoM / Use 7,547,719 7/13/2025 EU 1,534,390 5/21/2023 
Japan 4,612,414 5/21/2023 
Use 7,790,704 5/24/2021 EU 1,294,378 3/14/2025* 
EU 1,864,981 5/24/2021 
EU 1,889,838 5/24/2021 
Japan 3,813,875 5/24/2021 
Japan 4,546,919 5/24/2021 
Use 7,795,293 5/21/2023 EU 1,534,390 5/21/2023 
Japan 4,612,414 5/21/2023 
CoM / Use 8,052,993 8/1/2027 EU 2,152,237 
8/1/2027⁑
Japan 5,419,866 8/1/2027 
Japan 5,735,078 8/1/2027 
Japan 6,144,713