lgnd-20191231

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_____________________________________________________________________________________________

FORM 10-K

_____________________________________________________________________________________________


☒			ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Fiscal Year Ended December 31, 2019


☐			TRANSITION 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

LIGAND PHARMACEUTICALS INCORPORATED

(Exact name of registrant as specified in its charter)


Delaware						77-0160744
(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 Class	Trading Symbol	Name of Each Exchange on Which Registered
Common Stock, par value $.001 per share	LGND	The Nasdaq Global Market

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 ☒ No ☐

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 ☐ No ☒

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 ☒ No ☐

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 ☒ No ☐

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 the 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

☒

Accelerated Filer

☐

Non-accelerated Filer

☐

Smaller reporting company

☐

Emerging growth company

☐

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. ☐

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

The aggregate market value of the Registrant’s voting and non-voting stock held by non-affiliates was approximately $1.8 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 28, 2019. 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 21, 2020, the Registrant had 16,505,197 shares of Common Stock outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the Proxy Statement for the Registrant’s 2020 Annual Meeting of Stockholders to be filed with the Commission within 120 days of December 31, 2019 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.	Business	1
Item 1A.	Risk Factors	25
Item 1B.	Unresolved Staff Comments	36
Item 2.	Properties	36
Item 3.	Legal Proceedings	37
Item 4.	Mine Safety Disclosures	37

Part II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities	37
Item 6.	Selected Consolidated Financial Data	39
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	40
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	47
Item 8.	Consolidated Financial Statements and Supplementary Data	48
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	87
Item 9A.	Controls and Procedures	87
Item 9B.	Other Information	87

Part III
Item 10.	Directors, Executive Officers and Corporate Governance	89
Item 11.	Executive Compensation	89
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	89
Item 13.	Certain Relationships and Related Transactions, and Director Independence	89
Item 14.	Principal Accountant Fees and Services	89

Part IV
Item 15.	Exhibits, Financial Statement Schedules	90
Item 16.	Form 10 -K - Summary	90
Signatures			94


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
AAALAC			Accreditation of Laboratory Animal Care International
Ab Initio			Ab Initio Biotherapeutics, Inc.
Abvivo			Abvivo, LLC
ACOVA			ACOVA, Inc.
ADHF			Acute decompensated heart failure
Aldeyra			Aldeyra Therapeutics, Inc.
Amended Interest Purchase Agreement			Amended and Restated Interest Purchase Agreement, dated May 31, 2017, between the Company and CorMatrix Cardiovascular, Inc.
Amgen			Amgen, Inc.
ANDA			Abbreviated New Drug Application
API			Active pharmaceutical ingredient
Aptevo			Aptevo Therapeutics
Arcus			Arcus Biosciences, Inc.
ASC			Accounting Standards Codification
ASCO			American Society of Clinical Oncology
ASCT			Autologous Stem Cell Transplantation
ASU			Accounting Standards Update
Aziyo			Aziyo Med, LLC
Baxter			Baxter International, Inc.
BeiGene			BeiGene Switzerland GmbH
BendaRx			BendaRx Corp.
Bexson Biomedical			Bexson Biomedical, Inc.
BMS			Bristol Myers Squibb
CStone			CStone Pharmaceuticals (Suzhou) Co., Ltd.
CASI			CASI Pharmaceuticals, Inc.
Cardioxyl			Cardioxyl Pharmaceuticals, Inc.
CI-AKI			Contrast-induced acute kidney injury
Code of Conduct			Code of Conduct and Ethics Policy
Coherus			Coherus Biosciences, Inc.
CoM			Composition 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
Crystal			Crystal Bioscience, Inc.
Cumulus			Cumulus Oncology, Ltd.
CVR			Contingent value right
CyDex			CyDex Pharmaceuticals, Inc.


Daiichi Sankyo			Daiichi Sankyo Company, Ltd.
Dianomi			Dianomi Therapeutics, Inc.
DMF			Drug Master File
ESG			Environmental, Social and Governance
Eisai			Eisai Inc.
Eli Lilly			Eli Lilly and Company
ECM			Extracellular matrix
EPA			Environmental Protection Agency
ESPP			Employee Stock Purchase Plan, as amended and restated
EU			European Union
Exelixis			Exelixis, Inc.
FASB			Financial Accounting Standards Board
FDA			Food and Drug Administration
FSGS			Focal segmental glomerulosclerosis
GAAP			Generally accepted accounting principles in the United States
GBM			Glioblastoma
Genagon			Genagon Therapeutics AB
GCSF			Granulocyte-colony stimulating factor
GigaGen			GigaGen, Inc.
Gilead			Gilead Sciences, Inc.
GPCR			G-protein coupled receptor
GRA			Glucagon receptor antagonist
HanAll			HanAll Biopharma Co., Ltd.
Harbour			Harbour BioMed Shanghai Co., Ltd.
HBV			Hepatitis B Virus
HCC			Hepatocellular Carcinoma
Hikma			Hikma Pharmaceuticals PLC
HNO			Nitroxyl
Hovione			Hovione FarmCiencia, S.A.
Icagen			Icagen, Inc.
IPR&D			In-Process Research and Development
IRAK4			Interleukin-1 Receptor Associated Kinase-4
IRS			Internal Revenue Service
IV			Intravenous
iMBP			iMetabolic Biopharma Corporation
Immunovant			Immunovant Sciences GmbH
IND			Investigational New Drug
Kira Pharma			Kira Pharmaceuticals Ltd.
KSQ Therapeutics			KSQ Therapeutics, Inc.
Ligand			Ligand Pharmaceuticals Incorporated, including subsidiaries
LTP			Liver targeting prodrug
Lundbeck			Lundbeck A/S
Marinus			Marinus Pharmaceuticals, Inc.
MCM			Mineral Coated Microparticle
Melinta			Melinta Therapeutics, Inc.
Merck			Merck & Co., Inc.
Merrimack			Merrimack Pharmaceuticals, Inc.


Metabasis			Metabasis Therapeutics, Inc.
Metavant			Metavant Sciences Ltd.
Millennium			Millennium Pharmaceuticals, Inc.
MLA			Master License Agreement
MRSA			Methicillin-resistant Staphylococcus aureu
NASH			Non-alcoholic steatohepatitis
NDA			New Drug Application
NOLs			Net Operating Losses
Novan			Novan, Inc.
Novartis			Novartis AG
Nucorion			Nucorion Pharmaceuticals, Inc.
OMT			Open Monoclonal Technology, Inc.
Ono			Ono Pharmaceutical Co., Ltd.
Opthea			Opthea Limited
Orange Book			Publication identifying drug products approved by the FDA based on safety and effectiveness
Original Interest Purchase Agreement			Interest Purchase Agreement, dated May 3, 2016, between the Company and CorMatrix Cardiovascular, Inc.
Palvella			Palvella Therapeutics, Inc.
Par			Par Pharmaceutical, Inc.
Pfizer			Pfizer, Inc.
PFS			Progression-free Survival
Pharmacopeia			Pharmacopeia, Inc.
Phoenix Tissue			Phoenix Tissue Repair
PhoreMost			PhoreMost Limited
PPD			Post-Partum Depression
PSU			Performance stock unit
R&D			Research and Development
Retrophin			Retrophin Inc.
Roivant			Roivant Sciences GMBH
RSU			Restricted stock unit
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
Sermonix			Sermonix Pharmaceuticals, LLC
Spectrum			Spectrum Pharmaceuticals, Inc.
SQ Innovation			SQ Innovation, Inc.
Sunshine Lake Pharma			Sunshine Lake Pharma Co., Ltd.
Takeda			Takeda Pharmaceuticals Company Limited
Talem			Talem Therapeutics LLC
Tax Act			The Tax Cuts and Jobs Act
Teva			Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd. and Actavis, LLC
TG Therapeutics			TG Therapeutics, Inc.
TR-Beta			Thyroid hormone receptor beta
Valanbio			Valanbio Therapeutics, Inc.


VDP			Vernalis Design Platform
VentiRx			VentiRx Pharmaceuticals, Inc.
Vernalis			Vernalis plc
Verona			Verona Pharma plc
Viking			Viking Therapeutics
Vireo			Vireo Health
WuXi			WuXi Biologics Ireland Limited
WuXi Agreement			The Platform License Agreement, dated March 23, 2015, by and between Ligand and WuXi, as amended
Xi'an Xintong			Xi'an Xintong Medicine Research
X-ALD			X-linked adrenoleukodystrophy
xCella Biosciences			xCella Biosciences, Inc.
Zydus Cadila			Zydus 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^®, LTP^™, LTP technology^™, OmniAb^®, OmniMouse^®, OmniRat^®, OmniFlic^®, OmniClic^™, OmniChicken^® , Vernalis^®, VDP^™ and HepDirect^™ which are protected under applicable intellectual property laws and are our property. All other trademarks, trade names and service marks including Kyprolis^®,Evomela^®, Zulresso^TM, Minnebro^®,Baxdela^®, Carnexiv^TM, Conbriza^TM, Duavee^®, Promacta^®, SUREtechnology Platform^TM, Viviant^®, Vivitra^TM, 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 ^®, ^TM 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. We employ research technologies such as antibody discovery technologies, structure-based drug design, formulation science and liver targeted pro-drug technologies to assist companies in their work toward securing prescription drug and biologic approvals. We currently have partnerships and license agreements with over 120 pharmaceutical and biotechnology companies. Over 200 different programs are in various stages of commercialization and development and fully funded by our collaboration partners and licensees. We have contributed novel research and technologies for approved medicines that treat cancer, osteoporosis, fungal infections and PPD, among others. Our collaboration partners and licensees have programs currently in clinical development targeting cancer, seizure, 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, sale of Captisol material, and revenue from license, milestone and other service payments. 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.

2019 and Recent Major Business Highlights

Major Transactions and Strategic Investments

Consistent with our business model, we pursued novel investments to augment our technology platforms and assets. We acquired Ab Initio in a $12 million acquisition that brought Ligand a patented antigen technology that is synergistic with our OmniAb® therapeutic antibody discovery platform. We also invested $3 million in Dianomi in exchange for equity and a royalty rights on future development programs using Dianomi’s patented Mineral Coated Microparticle (MCM) technology. In 2019, we sold our assets and royalty rights for Promacta to Royalty Pharma for $827 million.

On February 11, 2020, we announced the signing of an agreement to acquire the core assets, partnered programs and ion channel technology from Icagen for $15 million in cash. Icagen will also be entitled to receive up to an additional $25 million of cash payments based on certain revenue achievements. The transaction is subject to certain closing conditions, including a vote of Icagen stockholders, and is expected to close in April 2020.

Corporate and Governance Highlights

Ligand’s Board of Directors is highly committed to policies and practices focused on environmental sustainability, positively impacting our social community and maintaining and cultivating good corporate governance. By focusing on such ESG policies and practices, we believe we can affect a meaningful and positive change in our community and maintain our open, collaborative corporate culture. We will continue our proactive shareholder and employee engagement in 2020. See www.ligand.com for information about our ESG policies and practices.

Sarah Boyce joined our Board, increasing the total number of Directors to nine. Also in 2019, two members of our Board, Nancy Gray and Sarah Boyce, were named to WomenInc’s Most Influential Corporate Directors list.

OmniAb Technology Platform Updates

We continue to invest in and expand the OmniAb Technology platform, and in 2019 we launched OmniClic™, a novel next-generation common light chain OmniChicken-based discovery technology focused on bispecific antibodies. We entered into nine new OmniAb platform license agreements in 2019 with Sanofi, Millennium/Takeda, GigaGen, Talem Therapeutics, Kira Pharma, Genagon, Ascella, Unity Biotechnology and Abvivo. Our scientists and our partners presented data highlighting the utility of the OmniAb platform at multiple conferences throughout the year, and we published multiple papers in peer-reviewed journals.

Development-stage OmniAb partners continue to report progress clinically; notable advancements include:

•CStone’s CS1001, an OmniAb-derived anti-PD-L1 antibody, that demonstrated promising antitumor activity with a complete response rate of 33.3% in a Phase 2 trial in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma. CStone also announced the start of a Phase 3 trial assessing CS1001 in combination with chemotherapy for treatment of gastric or gastro-esophageal cancers.

•Immunovant starting ASCEND-GO 2, a placebo-controlled Phase 2b trial evaluating OmniAb-derived IMVT-1401 in patients with Graves’ ophthalmopathy. IMVT-1401 is a fully human antibody that selectively binds to and inhibits the neonatal Fc receptor.

•Aptevo Therapeutics announcing positive Phase 1 data for APVO436, and GenMab highlighting clinical progress of the OmniAb-derived DuoBody-PD-L1x4-1BB.

Captisol Technology Updates

We reported the highest level of annual Captisol material sales in 2019, and we entered into new Captisol clinical use or license and supply agreements with a number of new partners, including: Millennium/Takeda; Merck KGaA, reVision Therapeutics; SQ Innovation; BendaRx; Bexson Biomedical, Valanbio; and others.

Kyprolis® is an Amgen product that utilizes Captisol in its formulation. We earn royalties on global sales of Kyprolis and also receive revenue for material sales. In September 2019, Amgen announced that the Phase 3 CANDOR study met its primary endpoint of progression-free survival. The regimen resulted in a 37% reduction in the risk of progression or death in patients with relapsed or refractory multiple myeloma. In October 2019, Amgen announced a strategic collaboration with BeiGene, an oncology-focused biotechnology company with an established infrastructure in China, to expand its oncology presence in the region. Kyprolis is currently under regulatory review in China for relapsed and refractory multiple myeloma.

New Captisol-enabled products were launched or expanded into new geographies in 2019, with SAGE launching ZULRESSO™ for the treatment of postpartum depression in the US, and CASI launching Evomela® in China.

Gilead Sciences announced on January 31, 2020 that they are working closely with global health authorities to respond to the novel coronavirus (COVID-19) outbreak through the appropriate experimental use of remdesivir (GS-5734). Remdesivir is formulated with Captisol. Gilead has initiated clinical trials together with Chinese authorities in patients who have been infected with COVID-19 to determine the safety and efficacy of remdesivir as a potential treatment for the virus. Remdesivir was also highlighted in The New England Journal of Medicine for treating the first case of COVID-19 in the United States. We have a non-exclusive supply agreement with Gilead, and our economics are built into Captisol material sales.

On February 20, 2020, we entered into a Captisol Use/Supply Agreement with China Resources Double-Crane Pharmaceuticals Co., Ltd, (“CR Double Crane”), pursuant to which we will supply Captisol to CR Double Crane for use in preclinical and clinical studies of remdesivir to treat the 2019 novel coronavirus, 2019-nCoV. We will receive revenues based on the amount of Captisol ordered by CR Double Crane.

Development-stage Captisol partners reported progress of programs in a variety of therapy areas, notably:

•Marinus announced positive results from a Phase 2 trial of ganaxolone in Refractory Status Epilepticus.

•Merck KGaA announced Phase 2 results for M6620, an ATR kinase inhibitor, demonstrating that addition of M6620 to gemcitabine extended PFS without added toxicity in patients with platinum-resistant cancer.

•Takeda announced results of a Phase 1 proof-of-concept study of Captisol-enabled TAK-925, a selective orexin type-2 receptor (OX2R) agonist, in individuals with narcolepsy type 1.

•SAGE announced plans for SAGE-689, a potential therapy for disorders associated with GABA hypofunction. SAGE expects to commence a Phase 1 trial in 2020.

Vernalis Design Platform (VDP) Updates

We continued to expand our portfolio of VDP-derived partnerships during 2019, following our 2018 acquisition of Vernalis and VDP partners continued to report on development progress.

•Verona Pharma announced positive data in a 4-week Phase 2b COPD trial with nebulized ensifentrine on top of tiotropium therapy. The primary endpoint was met at all doses, and ensifentrine produced clinically and statistically significant improvements in lung function. Verona intends to start Phase 3 in 2020.

•We entered a license agreement with Cumulus for VER250840, a novel, oral, Chk1 kinase inhibitor. We are eligible to receive more than $76 million of milestones and tiered royalties in the mid-to-high single digits.

•We entered into a VDP collaboration with PhoreMost and will share revenues with PhoreMost on any future licenses.

Additional Pipeline Developments

Our existing pipeline of partnered programs continued to advance, with multiple partners reporting on clinical and regulatory developments. Selected highlights include:

•Viking presented new results from a Phase 2 study of VK2809, its novel liver-selective thyroid hormone receptor beta agonist, in patients with non-alcoholic fatty liver disease and elevated low-density lipoprotein cholesterol, and also announced the start of a Phase 2b trial in patients with biopsy-confirmed NASH.

•Palvella announced that the Phase 3 pivotal portion of the seamless Phase 2/3 VALO study of PTX-022 for the treatment of patients with pachyonychia congenita had commenced.

•Retrophin announced new data from the Phase 2 DUET study, examining the impact of sparsentan on quality of life in patients with FSGS.

•Sermonix started a Phase 2 trial of lasofoxifene in breast cancer, and announced grant of Fast Track Designation.

•Sanofi presented positive Phase 3 data of sutimlimab in patients with cold agglutinin disease.

•Metavant informed Ligand that they no longer planned to initiate a proof-of-concept trial for RVT-1502 in Type 1 diabetes following requests from FDA for additional non-clinical studies. Metavant is evaluating its development plans for the program.

•Daiichi Sankyo announced the launch of MINNEBRO® (esaxerenone) tablets in Japan.

Select Partner Financing Events

Multiple partners completed financing events in 2019 to fund development of Ligand-partnered programs. Notably, CStone listed shares on the HKG and raised $266 million it is using to fund development of CS1001. Seelos completed a reverse merger and listed on Nasdaq. In conjunction with the transaction, Seelos generated gross proceeds of $18 million to fund its pipeline. And, Nucorion announced the closing of a $5 million Series B financing to support Phase development for its lead program, NCO-1010 for hepatitis B. NCO-1010 utilizes Ligand’s LTP Platform™ technology. Guangdong Ji-Bao Pharmaceutical Company of Guangzhou, China invested $4 million and Ligand invested $1 million in the Nucorion Series B round.

Internal Pipeline Highlights

We continue to invest in internal R&D with the goal to secure valuable partnerships in the future. In 2019, we announced positive top-line results from a Phase 1 trial of our internal Captisol-enabled (CE) Iohexol program. The trial achieved the primary endpoint by demonstrating pharmacokinetic bioequivalence of CE-Iohexol injection and a reference Iohexol injection (OMNIPAQUE™) after IV administration in healthy adults. CE-Iohexol injection was well tolerated, and adverse events were in line with the known safety profile of OMNIPAQUE. We plan to submit an IND with the FDA and to initiate a Phase 2 study in the U.S. in 2020. We also progressed five internal antibody-related programs leveraging our OmniChicken technology that we initiated in mid-2018. The programs are focused on targets for which biology is known, centered in the oncology space.

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, OmniChicken and OmniClic 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 and OmniClic platforms consist of genetically-engineered transgenic chickens which enable the generation of novel antibodies against targets that are not immunogenic in mammals like mice and rats. We acquired these technologies through the acquisition of OMT in January 2016 and Crystal in October 2017. As of December 31, 2019, we had entered into OmniAb platform license agreements with more than 40 collaboration partners, including 2 partners who have rights through our partnership with WuXi. Our OmniAb partners were working on approximately 180 active programs, of which 12 were in various stages of clinical trials as of December 31, 2019.

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. In addition to solid Captisol powder, we offer our partners access to cGMP manufactured aqueous Captisol concentrate. This product offering was established in 2017 to reduce cycle time and increase Captisol production capacity for large volume drug products. 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 Captisol-enabled drugs. We also have active DMFs in Japan, China and Canada. As of December 31, 2019, Captisol-enabled drugs were being marketed in more than 70 countries, and over 40 partners had Captisol-enabled drugs in development.

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. As of December 31, 2019, we have agreements with 10 partners for active research collaboration using VDP technology on a total of 17 active programs.

HepDirect/LTP Technology Platform

The HepDirect platform is a first generation liver-targeting prodrug technology designed to deliver certain phosphorus-containing drugs to the liver by using a proprietary chemical modification that renders an API biologically inactive until cleaved by a liver-specific enzyme. The HepDirect™ technology may improve the efficacy and/or safety of certain drugs and can be applied to marketed or new drug products to treat liver diseases or diseases caused by hemostasis imbalance of circulating molecules controlled by the liver.

Our LTP platform is a broad second generation liver-targeting prodrug technology that has an activation mechanism similar to HepDirect but with broader applications and many improved features. The proprietary chemical modifications can be used with many chemical classes of drugs in addition to phosphorus-containing compounds and have multiple chemistry strategies, designed to improve flexibility and success rates. In addition, the second generation technology eliminates the undesirable by-products released during activation of the first generation prodrugs. As of December 31, 2019, we had entered into HepDirect/LTP platform agreements with six partners, all of whom had active programs.

SUREtechnology Platform (owned by Selexis)

We acquired economic rights to various SUREtechnology Platform programs from Selexis. 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. As of December 31, 2019, we are entitled to certain economic rights to SUREtechnology Platform license agreements with 14 partners developing or having commercialized 23 programs.

Partners and Licensees

We currently have partnerships and license agreements with over 120 pharmaceutical and biotechnology companies. In addition to the table below, we also have more than 10 undisclosed partners and licensees.

Big Pharma

Ticker

Generics, continued

Ticker

Biotech, continued

Ticker

AbbVie

ABBV

Hikma

HIK

MEI

MEIP

AstraZeneca

AZN

Par

Private

Melinta

MLNT

Baxter

BAX

Zydus Cadila

CADILAHC

Menarini

Private

Boehringer Ingelheim

Private

Biotech

Ticker

Meridian Labs

Private

BMS

BMY

ABBA

Private

Metavant

Private

Daiichi Sankyo

DSKY

ABL Bio

298380

Merrimack

MACK

Eli Lilly

LLY

Abvivo

Private

Novan

NOVN

Eisai

4523

Aldeyra

ALDX

Novogen

NVGN

GSK

Amgen

AMGN

Nucorion

Private

Janssen

JNJ

Arcus

RCUS

Opthea

OPT

Merck

MRK

Asahi Kasei

3407

Outlook

OTLK

Merck KGaA

MRK.DE

Ascella

Private

Palvella

Private

Novartis

NVS

BendaRx

Private

Phoenix Tissue

Private

Ono

4528

Bexson Biomedical

Private

Precision Biologics

Private

Otsuka

4768

bluebird bio

BLUE

Retrophin

RTRX

Pfizer

PFE

Cantex

Private

Revision

Private

Sanofi

SNY

Celgene

CELG

SAGE

Takeda

4502

Corvus

CRVS

Seattle Genetics

SGEN

Specialty Pharma

Ticker

CStone

2616.HK

Seelos

SEEL

Acrotech

Private

Cumulus

Private

Servier

Private

Aytu Bioscience

AYTU

Curon

Private

Sunshine Lake

Private

Aziyo

Private

CURx

Private

Surface

SURF

Beloteca

Private

Aptevo

APVO

Symphogen

Private

CASI

Electra

Private

Talem

Private

CorMatrix

Private

Exelixis

EXEL

Teneobio

Private

CTI Biopharma

CTIC

Five Prime

FRPX

TG Therapeutics

TGTX

Cuda

Private

F-Star

Private

Tizona

Private

Ferring

Private

Genmab

GEN

Unity

UBX

Gloria

2437

Genagon

Private

Valanbio

Private

Lundbeck

LUN

Genekey Biotech

Private

Vaxxas

Private

Proximagen

Private

Glenmark

GLENMARK

Vega

Private

Sedor

Private

GigaGen

Private

VenBio

Private

Sermonix

Private

Gilead Sciences

GILD

VentiRx

Private

Shire

SHPG

HanAll

9420

Verona

VRNA

SQ Innovation

Private

Harbour

Private

Vertex

VRTX

Teijin

TINLF

IBC Generium

Private

Viking

VKTX

Vireo Health

Private

iMetabolic

Private

Virtuoso

Private

Generics

Ticker

Immunovant

IMVT

xCella

Private

Alvogen

Private

J-Pharma

Private

Xi'an Xintong

Private

BioCad

Private

Kira

Private

XTL Bio

XTLB

Coherus

CHRS

KSQ

Private

WuXi

603259

Gedeon Richter

GEDSF

Marinus

MRNS

Zhilkang Hongyi

Private

Commercial and Clinical Stage Partnered 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 100 undisclosed preclinical programs.

Approved

Partner Name

Program

Therapeutic Area

Acrotech/CASI

Evomela

Cancer

Alvogen

Voriconazole

Infectious Disease

Amgen/Ono

Kyprolis

Cancer

Aytu

Tuzistra

Infectious Disease

Aziyo

ECM portfolio

Medical device/Cardiology

Baxter

Nexterone

Cardiovascular

Biocad

Teberif

Inflammatory/Metabolic

Exelixis/Daiichi-Sankyo

Minnebro

Cardiovascular

Hikma

Voriconazole

Infectious Disease

Lundbeck

Carnexiv

Central Nervous System

Melinta

Baxdela

Infectious Disease

Menarini

Frovatriptan

Central Nervous System

Merck

Noxafil-IV

Infectious Disease

Par

Posaconazole

Infectious Disease

Pfizer

Viviant/Conbriza

Inflammatory/Metabolic

Pfizer

Duavee

Inflammatory/Metabolic

Pfizer

Vfend-IV

Infectious Disease

SAGE

Zulresso

Central Nervous System

Zydus Cadila

Vivitra

Cancer

Zydus Cadila

Bryxta/ZyBev

Cancer

Zydus Cadila

Exemptia

Inflammatory/Metabolic

Zydus Cadila

Vortuxi

Inflammatory/Metabolic

Phase 3/Pivotal or Regulatory Submission Stage

Partner Name

Program

Therapeutic Area

Aldeyra

Reproxalap

Other/Undisclosed

Biocad

BCD-066

Blood Disorders

CStone

CS1001

Cancer

IBC Generium

GNR-008

Severe and Rare

Novan

SB206

Infectious Disease

Outlook Therapeutics

ONS-5010

Other/Undisclosed

Retrophin

Sparsentan

Severe and Rare

Sanofi

Sutimlimab

Blood Disorders

Sedor

CE-Fosphenytoin

Central Nervous System

Sunshine Lake

Vilazodone

Central Nervous System

Takeda

Pevonedistat

Cancer

Phase 2

Partner Name

Program

Therapeutic Area

Cantex

CX-01

Cancer

Cardioxyl/BMS

BMS986231

Cardiovascular

CTI Biopharma

Tosedostat

Cancer

Eisai

FYCOMPA

Central Nervous System

Gilead

GS-5734

Infectious Disease

Gloria

GLS010

Cancer

Immunovant

IMVT-1401

Inflammatory/Metabolic

J-Pharma

JPH-203

Cancer

Marinus

Ganaxalone IV

Central Nervous System

Merck

M6620

Cancer

Metavant

RT-1502

Inflammatory/Metabolic

Novartis

KLM465

Blood disorders

Novartis

CE-Trametinib

Cancer

Novartis

ECF843

Inflammatory/Metabolic

Opthea

OPT-302

Other/Undisclosed

Palvella

PTX-022

Other/Undisclosed

Precision Biologics

NPC-1C

Cancer

Sedor

CE-Budesonide

Inflammatory/Metabolic

Seelos

Aplindore

Central Nervous System

Sermonix

Lasofoxifene

Cancer

VentiRx

VTX-2337

Cancer

Verona

Ensifentrine

Inflammatory/Metabolic

Viking

VK5211

Inflammatory/Metabolic

Viking

VK2809

Inflammatory/Metabolic

Viking

VK0214

Inflammatory/Metabolic

Viking

VK0612

Inflammatory/Metabolic

Xi'an Xintong

Pradefovir

Infectious Disease

XTL Bio

hCDR1

Severe and Rare

Phase 1

Partner Name

Program

Therapeutic Area

Amgen

AMG-330

Cancer

Aptevo

APVO436

Cancer

Arcus

AB122

Cancer

Corvus

Cifordenant

Cancer

CSL

CSL-324

Cancer

Cuda

Cudafol

Central Nervous System

F-Star

FS-102

Cancer

Gedeon Richter

Bevacizumab

Cancer

Gedeon Richter

RGB-03

Inflammatory/Metabolic

Genekey Biotech

PCSK-9

Inflammatory/Metabolic


Genmab	Gen1046	Cancer
Gossamer Bio	PFK-158	Cancer
HanAll/Harbour	HL161	Inflammatory/Metabolic
Janssen	JNJ64007957	Cancer
Janssen	JNJ67371244	Cancer
MEI Pharma	ME-344	Cancer
Meridian	ML-061	Cancer
Novartis	MIK-665	Cancer
Novartis	BCL-201	Cancer
Phoenix Tissue	PTR-01	Other/Undisclosed
Proximagen	CXCR4	Cancer
Servier	S55746/S64315	Cancer
Symphogen	SYM022/SYM023	Cancer
Takeda	TAK-020	Inflammatory/Metabolic
Takeda	TAK-925	Severe and Rare
Teva	Anti-IL5	Central Nervous System
Vaxxas	Nanopatch	Infectious Disease
VentiRx Pharma	VTX-1463	Cancer
Xi'an Xintong	MB07133	Cancer

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)

In the first quarter of 2019, we sold our Promacta related intellectual property rights licensed to Novartis, including the royalty stream on worldwide net sales of Promacta to Royalty Pharma for $827.0 million in cash. See detail in “Item 8. Financial Statements and Supplementary Data—Notes to Consolidated Financial Statements—Note (2), Sale of Promacta License.”

Prior to the sale, Promacta accounted for nearly 50% of total revenue. We are entitled to no future royalty revenue from Promacta.

Kyprolis (Amgen)

We supply Captisol to Amgen for use with Kyprolis (carfilzomib), 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 million	1.5%
		$250 to $500 million	2.0%
		$500 to $750 million	2.5%
		>$750 million	3.0%

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 revenue from clinical and commercial Captisol material sales and royalties on annual net sales of Kyprolis.

Evomela (Acrotech and CASI)

We supply Captisol to Acrotech Biopharma for sales of Evomela in the U.S. and to CASI Pharmaceuticals for sales of Evomela in China. Evomela received market approval by the China National Medical Products Administration (NMPA). It is the only approved and commercially available melphalan product in China. Evomela is a Captisol-enabled melphalan IV formulation which is approved by the FDA 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, Acrotech Biopharma has marketing rights worldwide excluding China and CASI Pharmaceuticals has rights to market in China. 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. Acrotech and CASI’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. As described herein, we have entered into a settlement agreement with Teva and Acrotech Biopharma (the holder of the NDA for Evomela) which will allow Teva to market a generic version of Evomela in the United States on June 1, 2026, or earlier under certain circumstances. 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 Acrotech and CASI by prior written notice.

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.

Zulresso (SAGE)

We have a license agreement with SAGE, related to SAGE's Zulresso, a Captisol-enabled formulation of brexanolone for the treatment of PPD. SAGE announced marketing approval on March 21, 2019 for Zulresso. Under the terms of the agreement, we receive royalties and revenue from Captisol material sales.

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. In January 2020, Merck received approval in Japan for NOXAFIL-IV. We receive our commercial compensation for this program through the sale of Captisol, and we do not receive a royalty on this program.

Baxdela IV (Melinta)

Melinta’s Baxdela IV is a Captisol-enabled delafloxacin-IV that was approved 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 future sales by Melinta, and revenue from Captisol material sales.

Duavee or Duavive (bazedoxifene/conjugated estrogens) and Viviant/Conbriza (Pfizer)

Pfizer is marketing bazedoxifene, a selective estrogen receptor modulator, under the brand names Viviantand 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, we have 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, Zybev 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 and Zybev (bevacizumab biosimilar) is marketed in India for various indications. Zydus Cadila uses the Selexis technology platform for Bryxta and Zybev. 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 MINNEBROTablets (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.

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 may be entitled to receive potential 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.

TR-Beta - VK2809 and VK0214 (Viking)


Our partner, 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 million	3.5%
		$500 to $750 million	5.5%
		>$750 million	7.5%

BMS-986231 (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, revenue from Captisol material sales and royalties on potential future sales by BMS.

IMVT-1401/HL161 (Immunovant, HanAll and Harbour)

Our partner, HanAll has granted Immunovant an exclusive license for the development, manufacture and marketing of IMVT-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 2 clinical trial 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.

SARM - VK5211 (Viking)


Viking is also 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. In the fourth quarter of 2017, Viking announced positive results from its Phase 2 trial in patients who suffered hip fracture. 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 million	7.25%
		$500 to $750 million	8.25%
		>$750 million	9.25%

PTX - 022 (Palvella)


We acquired the economic rights to PTX-022 from Palvella in December 2018. PTX-022 is a novel, topical formulation comprising high-strength rapamycin in development to treat pachyonychia congenita (PC). PC is a serious, chronically debilitating lifelong monogenic rare skin disease with no approved treatment. Palvella is continuing enrollment for a pivotal Phase 2/3 clinical trial for PC and is expected to have top line data in late 2020.	PTX - 022 (Palvella)
		< $50 million	5.00%
		$50 to $100 million	7.50%
		>$100 million	9.80%

Lasofoxifene (Sermonix)

Lasofoxifene is a selective estrogen receptor modulator for osteoporosis treatment and other diseases, discovered through the research collaboration between us and 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 potential future net 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 over $25 million in regulatory and development milestones from Millennium/Takeda, revenue from Captisol material sales, and royalties on potential future net sales.

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.

JNJ64007957 (Janssen)

Our partner, Janssen, is developing JNJ64007957, a BCMAxCD3 bispecific antibody discovered in part with the OmniAb platform technology. Janssen is currently conducting two Phase 1 trials, as a single agent and in combination with daratumumab in multiple myeloma. We are entitled to earn development and regulatory milestones based on the development of JNJ64007957.

JNJ-67371244 (Janssen)

Janssen is also developing JNJ-67371244, an anti-CD33xCD3 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 development and regulatory milestones based on the development of JNJ-67371244.

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, revenue from Captisol material sales, and royalties on potential future 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 development and regulatory milestones and royalties on potential future net sales.

Gen1046 (GenMab)

Our partner, GenMab, is currently conducting a Phase 1 trial of Gen1046 for use in patients with malignant solid tumors. Under the terms of the agreement with GenMab, we are entitled to clinical and regulatory milestones and royalties on potential future sales.

SYM022 and SYM023 (Symphogen)

Our partner, Symphogen, is currently conducting Phase 1 trials of SYM022 and SYM023 to determine if it is safe and tolerable for patients with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy for which no standard therapy is available. Under the terms of the agreement with Symphogen, we are entitled to sublicense revenues, milestones and royalties on potential future net 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 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 conducting multiple Phase 1 trials 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 (CStone)

WuXi has also outlicensed the rights to certain programs using the OmniAb technology to CStone. CStone, 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.

SB206 (Novan)

We acquired certain economic rights to SB206 from Novan in May 2019. SB206 is a topical nitric-oxide antiviral gel for the treatment of viral skin infections, including molluscom contagiosum (MC). MC is an infection which causes skin-lesion that affects approximately 6 million people in the United States annually, with the greatest incidence in children aged one to 14 years. In Q1 2020, Novan announced that it did not achieve statistically significant results for its primary end point from its

Phase 3 pivotal trials of SB206 in MC. Novan continues to explore financial as well as strategic options in order to progress SB206.

Ciforadenant – CPI-444 (Corvus)

Our partner, Corvus, is conducting a Phase 1b/2 clinical trial in patients with renal cell carcinoma and metastatic castration resistant prostate cancer to evaluate Ciforadenant, an antagonist of adenosine A2A, in combination with the immunotherapy drug atezolizumab. Positive preliminary data was presented in February at ASCO 2020 Genitourinary Cancers Symposium (ASCO-GU) and additional data will be presented at ASCO 2020 in May/June. Ciforadenant 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.

Perampanel IV (Eisai)

Our partner, Eisai, recently completed an open-label, single group assignment, multicenter, Phase 2 study in Japan to evaluate the safety and tolerability of intravenous perampanel, formulated with Captisol, as substitute for oral tablets as an adjunctive therapy in patients with partial onset seizures (including secondarily generalized seizures) or primary generalized tonic-clonic seizures. The primary endpoint was the number of patients with adverse events and serious adverse events. We are entitled to revenue from Captisol material sales and tiered royalties on potential future sales.

USL-311 (Proximagen)

Our partner Proximagen, a wholly owned subsidiary of ACOVA, is developing USL-311, a CXCR4 antagonist, for the potential treatment of glioblastoma (GBM) and solid tumors. Proximagen is also investigating USL-311 for the potential treatment of inflammation. USL-311 is currently in a Phase 1/2 trial in patients with advanced solid tumors and relapsed/recurrent GBM. We are entitled to development and regulatory milestones and royalties on potential future sales.

Pradefovir (Xi'an Xintong)

Our Chinese licensee, Xi'an Xintong Medicine Research (following its acquisition of Chiva Pharmaceuticals), are developing pradefovir, an oral liver-targeting prodrug of the HBV DNA polymerase/reverse transcriptase inhibitor adefovir, for the potential treatment of hepatitis B virus (HBV) infection. Pradefovir was developed using Ligand’s HepDirect technology. In September 2019, Xi'an Xintong Medicine Research reported positive results from a Phase 2 trial of pradefovir, showing good efficacy, safety and tolerability. At the dose of 75 mg, the reduction of DNA viral load, the percentage of no viral load detected, and HBeAg negative conversion rate were better than tenofovir disoproxil fumarate (TDF) after 24 weeks of treatment. Overall incidence of side effects was less than TDF and there was no renal or skeletal toxicity. Xi'an Xintong Medicine Research is planning for a Phase 3 trial. We are entitled to an annual licensing maintenance fee and royalties on potential future sales.

MB07133 (Xi'an Xintong)

Chinese licensee Xi'an Xintong Medicine Research are also developing MB07133, a liver specific, HepDirect prodrug of cytarabine monophosphate, for the potential treatment of hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma. MB07133 is currently in Phase 1 in China. We are entitled to an annual licensing maintenance fee 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

CE-Budesonide

Sedor

8.0% - 10.0%

CE-Meloxicam

Sedor

8.0% - 10.0%

Ciforadenant

Corvus

Mid-single digit to low-teen royalty

DGAT-1

Viking

3.0% - 7.0%

Duavee

Pfizer

0.5% - 2.5%

Ensifentrine (RPL554)

Verona

Low to mid-single digit royalty

FBPase Inhibitor (VK0612)

Viking

7.5% - 9.5%

IRAK4

TG Therapeutics

6.0% - 9.5%

Kyprolis

Amgen

1.5% - 3.0%

Lasofoxifene

Sermonix

6.0% - 10.0%

Mineral Coated Microparticle

Dianomi

2.0% - 3.0%

OmniAb-Genagon

Genagon

4.0% - 6.0%

OmniAb-GigaGen

GigaGen

Mid-single digit royalty

OmniAb-iMetabolic

iMetabolic

<6%

OmniAb-Kira

Kira

Low to mid-single digit royalty

OmniAb-Takeda

Takeda

Low single digit royalty

Oral EPO

Viking

4.5% - 8.5%

PTX-022

Palvella

5.0% - 9.8%

RVT-1502

Metavant

Low double digit to mid-teen royalty

SARM (VK5211)

Viking

7.25% - 9.25%

SB206

Novan

7.0% - 10.0%

TR Beta (VK2809 and VK0214)

Viking

3.5% - 7.5%

Viviant/Conbriza

Pfizer

0.5% - 2.5%

Various

Nucorion

4.0% - 9.0%

Various

Seelos

4.0% - 10.0%

Ligand Licenses With Fixed Royalties

Program

Licensee

Royalty Rate

4-1BB

Zhilkang Hongyi

Low single digit royalty

AB122

Arcus

Low single digit royalty

Baxdela

Melinta

2.5%

CE-Fosphenytoin

Sedor

11%

CS1001

CStone

Low single digit royalty

Evomela

Acrotech/CASI

20%

KLM465

Novartis

14.5% (6.5% in year one)

MB07133

Xi'an Xintong

ME-143

MEI Pharma

Low single digit royalty

ME-344

MEI Pharma

Low single digit royalty

OmniAb-KSQ Therapeutics

KSQ Therapeutics

Single digit royalty

PCSK-9

Genekey

Low single digit royalty

Pradefovir

Xi'an Xintong

Reproxalap

Aldeyra Therapeutics

Low single digit royalty

Sparsentan

Retrophin

Various

Gloria

Low single digit royalty

Zulresso

SAGE

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

> $800,000

Preclinical

> $20,000

Viking

$1,500,000

Captisol

> $180,000

Clinical

> $450,000

Janssen

$238,000

Vernalis

> $350,000

Regulatory

> $1,600,000

Seelos

$139,000

LTP/Hep Direct

> $275,000

Commercial

> $1,200,000

Retrophin

$100,000

NCE/Other

> $1,700,000

Other

> $50,000

Corvus

$91,000

Total

> $3,300,000

Total

> $3,300,000

Xi'an Xintong

$44,000

Other

> $1,188,000

Total

> $3,300,000

*All tables exclude our annual access fees and collaboration revenue for development work.

Internal Development Programs

We have a number of internal development or unpartnered programs focused on a wide-range of potential indications or disease. In July 2019, we announced positive top-line results from a Phase 1 clinical trial of our internal Captisol-enabled (CE) Iohexol program. The trial achieved the primary endpoint by demonstrating pharmacokinetic bioequivalence of CE-Iohexol injection and a reference Iohexol injection (OMNIPAQUE™) after IV administration in healthy adults. CE-Iohexol injection was well tolerated, and adverse events were in line with the known safety profile of OMNIPAQUE. On November 8, 2019, we presented the positive results from the Phase 1 clinical trial at ASN Kidney week 2019 in Washington D.C. The CE-Iohexol program was established in January 2018 to develop a Captisol-enabled, next-generation contrast agent for diagnostic imaging with a reduced risk of renal toxicity. CI-AKI is the acute impairment of renal function following intravascular administration of an iodinated contrast agent, and occurs most frequently following coronary angiography, percutaneous coronary intervention and contrast-enhanced computed tomography, especially among patients at risk of renal injury such as those with advanced age, diabetes or heart failure. Currently no products are approved to prevent or treat CI-AKI in this setting, and therefore We believe a significant opportunity exists for a safer formulation of contrast agents. The goal is for CE-Iohexol to improve upon the limitations of existing contrast agents and enable a future partner to gain meaningful market share. We plan to submit an IND with the FDA and initiate a Phase 2 study in the U.S. in second half of 2020.

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:

Program

Development Stage

Targeted Indication or Disease

Luminespib/Hsp90 Inhibitor

Phase 2

Oncology

FAAH Inhibitor

Phase 1

Pain

CE-Sertraline, Oral Concentrate

Phase 1

Depression

CE-Iohexol

Phase 1

Diagnostics

CCR1 Antagonist

Preclinical

Oncology

CE-Busulfan

Preclinical

Oncology

CE-Cetirizine Injection

Preclinical

Allergy

CE-Silymarin for Topical formulation

Preclinical

Sun damage

FLT3 Kinase Inhibitors

Preclinical

Oncology

GCSF Receptor Agonist

Preclinical

Blood disorders

Liver Specific Glucokinase Activator

Preclinical

Diabetes

Anti-B7-H3

Preclinical

Oncology

Anti-TIM3

Preclinical

Oncology

Anti-TIGIT

Preclinical

Oncology

Anti-CD38

Preclinical

Oncology

Chk1 Inhibitor

Preclinical

Oncology

Manufacturing

We contract with a third party manufacturer, Hovione, for Captisol production. Hovione operates FDA-inspected sites in the United States, Macau, Ireland and Portugal. Manufacturing and distribution operations for Captisol are performed primarily at Hovione's Portugal and Ireland facilities. 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.

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.”

Environmental, Health and Safety (EHS)

We are committed to providing a safe and healthy workplace, promoting environmental excellence in our communities, and complying with all relevant regulations and industry standards. We establish and monitor programs to reduce pollution, prevent injuries, and maintain compliance with applicable regulations. By focusing on such practices, we believe we can affect a meaningful, positive change in our community and maintain a healthy and safe environment. During 2019, our animal health facility in Emeryville, California, received accreditation from Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), a nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. We expect to continue our effort and to refine our EHS policies and practices in 2020.

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. These activities are subject to additional regulations that apply at the state level. There are similar regulations in other countries as well. For both currently marketed products 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. 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. During the first quarter of 2019, we sold our Promacta related intellectual property rights to RPI Finance Trust, doing business as “Royalty Pharma”. We expect no future royalty revenue from Promacta.

Kyprolis

Patents protecting Kyprolis include those owned by Amgen and those owned by us. The United States patent listed in the Orange Book relating to Kyprolis with the latest expiration date is not expected to expire until 2029. Patents and applications owned by Ligand relating to the Captisol component of Kyprolis are not expected to expire until 2033. Amgen has filed suit against several generic drug companies over their applications to make generic versions of Kyprolis, with a decision expected by April 2020. The type of patent protection (e.g., composition of matter or use) for each patent listed in the Orange Book and the expiration dates for each 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.

Kyprolis

United States

Corresponding Foreign

Type of Protection

U.S. Patent No.

U.S. Expiration Date

Jurisdiction

Patent Number

Expiration Date‡

CoM

7,232,818

4/14/2025

1,745,064

4/14/2025

1,781,688

8/8/2025

2,266,999

8/8/2025

2,270,026

8/8/2025

3,101,026

8/8/2025

Japan

4,743,720

8/8/2025

Japan

5,394,423

4/14/2025

CoM

7,417,042

7/20/2026

1,781,688

8/8/2025

2,266,999

8/8/2025

2,270,026

8/8/2025

3,101,026

8/8/2025

Japan

4,743,720

8/8/2025

Japan

5,394,423

4/14/2025

Use

7,491,704

4/14/2025

1,745,064

4/14/2025

1,781,688

8/8/2025

2,266,999

8/8/2025

2,270,026

8/8/2025

3,101,026

8/8/2025

Japan

4,743,720

8/8/2025

Japan

5,394,423

4/14/2025

CoM

7,737,112

12/7/2027

1,819,353

12/7/2025

2,260,835

12/7/2025

2,261,236

12/7/2025

Japan

4,990,155

12/7/2025

Japan

5,108,509

5/9/2025

Use

8,129,346

4/14/2025

1,745,064

4/14/2025

Japan

5,394,423

4/14/2025

Japan

5,616,569

4/14/2025

CoM

8,207,125

4/14/2025

1,781,688

8/8/2025

1,745,064

4/14/2025

Japan

5,394,423

4/14/2025

Japan

5,616,569

4/14/2025

Japan

4,743,720

8/8/2025

CoM / Use

8,207,126

4/14/2025

1,745,064

4/14/2025

Japan

5,394,423

4/14/2025

Japan

5,616,569

4/14/2025

Use

8,207,127

4/14/2025

1,745,064

4/14/2025

Japan

5,394,423

4/14/2025

Japan

5,616,569

4/14/2025

CoM / Use

8,207,297

4/14/2025

1,745,064

4/14/2025

Japan

5,394,423

4/14/2025

Japan

5,616,569

4/14/2025

CoM

9,493,582

2/27/2033

Japan

6,517,725

2/27/2033

Use

9,511,109

10/21/2029

2,796,134

10/21/2029

Japan

5,675,629

10/21/2029

Japan

6,081,964

10/21/2029

^‡Expiration dates of European and Japanese patents are calculated as 20 years from the earliest nonprovisional filing date to which priority is claimed, and do not take into account extensions that are or may be available in these jurisdictions.

Captisol

Patents and pending patent applications covering Captisol and methods of making Captisol are owned by us. The patents covering the Captisol product, if issued, with the latest expiration date would not be set to expire until 2033 (see, e.g., U.S. Patent No. 9,493,582 (expires Feb. 27, 2033)). Other patent applications covering methods of making Captisol, if issued, potentially have terms to 2040. We have asserted U.S. Patents 8,410,077, 9,200,088, and 9,493,582 against Teva in connection with their attempt to obtain FDA approval to manufacture and sell a generic version of EVOMELA^®. We also own several patents and pending patent applications covering drug products containing Captisol as a component. The type of patent protection (e.g., composition of matter or use) and the expiration dates for several issued patents covering Captisol are provided in the following table. In addition, certain related patents and applications in the commercially important jurisdictions of Europe and Japan are listed in the following table.

Captisol

United States

Corresponding Foreign

Type of Protection

U.S. Patent No.

U.S. Expiration Date

Jurisdiction

Patent Number

Expiration Date‡

CoM

8,114,438

10/26/2025

2,708,225

4/22/2025

Japan

6,141,906

4/22/2025

Japan

6,538,739

4/22/2025

CoM

10,117,940

4/22/2025

2,708,225

4/22/2025

Japan

6,141,906

4/22/2025

Japan

6,538,739

4/22/2025

CoM

7,629,331

10/26/2025

1,945,228

10/26/2025

2,335,707

10/26/2025

2,581,078

10/26/2025

Japan

5,465,432

10/26/2026

Use

8,049,003

12/19/2026

2,583,668

10/26/2025

CoM

8,846,901

10/26/2025

1,945,228

10/26/2025

2,335,707

10/26/2025

2,581,078

10/26/2025

Japan

5,465,432

10/26/2026

CoM

8,829,182

10/26/2025

1,945,228

10/26/2025

2,335,707

10/26/2025

2,581,078

10/26/2025

2,952,197

10/26/2025

Japan

5,465,432

10/26/2026

CoM/Use/MoM

9,617,352

6/8/2026

2,952,197

10/26/2025

CoM/MoM

10,202,468

10/26/2025

N/A

CoM / Use

7,635,773

3/13/2029

Japan

4,923,144

4/28/2029

Japan

6,039,721

4/28/2029

Japan

6,276,828

4/28/2029

Japan

6,444,548

4/28/2029

CoM

8,410,077

3/13/2029

Japan

4,923,144

4/28/2029

Japan

6,039,721

4/28/2029

Japan

6,276,828

4/28/2029

Japan

6,444,548

4/28/2029

CoM

9,200,088

3/13/2029

Japan

4,923,144

4/28/2029

Japan

6,039,721

4/28/2029

Japan

6,276,828

4/28/2029

Japan

6,444,548

4/28/2029

CoM

9,750,822

3/13/2029

Japan

4,923,144

4/28/2029

Japan

6,039,721

4/28/2029

Japan

6,276,828

4/28/2029

Japan

6,444,548

4/28/2029

CoM

10,117,951

3/13/2029

Japan

4,923,144

4/28/2029

Japan

6,039,721

4/28/2029

Japan

6,276,828

4/28/2029

Japan

6,444,548

4/28/2029

MoM

9,751,957

6/28/2033

2,814,849

2/14/2033

Japan

6,508,944

2/14/2033

CoM

9,493,582

2/27/2033

Japan

6,517,725

2/27/2033

MoM

10,323,103

2/27/2033

Japan

6,517,725

2/27/2033

CoM/MoM

10,040,872

2/27/2033

Japan

6,557,144

10/21/2033

^‡ Expiration date of European and Japanese patents are calculated as 20 years from the earliest nonprovisional filing date to which priority is claimed, and do not take into account extensions that are or may be available in these jurisdictions.

Subject to compliance with the terms of the respective agreements, our rights to receive royalty payments under our licenses with our exclusive licensors typically extend for the life of the patents covering such developments. For a discussion of the risks associated with patent and proprietary rights, see below under “Item 1A. Risk Factors.”

OmniAb

Our OmniAb® therapeutic antibody platforms, including OmniRat®, OmniMouse® and OmniChicken™, produce naturally optimized, fully human antibodies in animals. We have received patent protection on OmniAb antibodies and methods in 30 countries, including the United States, multiple countries throughout Europe, Japan and China (see selected cases listed in the table below) and have 56 patent applications pending in 24 countries worldwide. The patents and applications owned by us are expected to expire between 2028 and 2034 and partners are able to use the OmniAb patented technology to generate novel antibodies, which may be entitled to additional patent protection.

OmniAb in OmniMouse and OmniRat

United States

Corresponding Foreign

Type of Protection

U.S. Patent No.

U.S. Expiration Date

Jurisdiction

Patent Number

Expiration Date‡

CoM

8,703,485

10/10/2031

2,152,880