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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________________________________________________________________________________
FORM 10-K
_____________________________________________________________________________________________
Mark One
x
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Fiscal Year Ended December 31, 2016
OR
o
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
Name of Each Exchange on Which Registered
Common Stock, par value $.001 per share
The NASDAQ Global Market of The NASDAQ Stock Market LLC
Preferred Share Purchase Rights
The 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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post 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, or a non-accelerated filer or a smaller reporting company. See definition of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large Accelerated Filer  x
 
Accelerated Filer  o
 
Non-accelerated Filer  o
 
Smaller reporting company  o
 
 
(Do not check if a smaller reporting company)
 
 
 
 
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 $2.3 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 30, 2016. 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.



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As of February 9, 2017, the Registrant had 20,919,894 shares of Common Stock outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the Proxy Statement for the Registrant’s 2017 Annual Meeting of Stockholders to be filed with the Commission on or before May 1, 2017 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

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.
 
 
Part III
 
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
 
 
Part IV
 
Item 15.
Signatures






















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GLOSSARY OF TERMS AND ABBREVIATIONS
Abbreviation
Definition
2019 Convertible Senior Notes
$245.0 million aggregate principal amount of convertible senior unsecured notes due 2019
ABSSSI
Acute bacterial skin and skin structure infections
ADHF
Acute decompensated heart failure
Amended ESPP
Employee Stock Purchase Plan, as amended and restated
Amgen
Amgen, Inc.
AML
Acute myeloid leukemia
ANDA
Abbreviated New Drug Application
AOCI
Accumulated Other Comprehensive Income
API
Active pharmaceutical ingredient
ASCT
Autologous Stem Cell Transplantation
ASU
Accounting Standards Update
Azure
Azure Biotech, Inc.
BACE
Beta-secretase
Baxter
Baxter International, Inc.
BMS
Bristol Myers Squibb
CStone
CStone Pharmaceuticals Co., Ltd
Cardioxyl
Cardioxyl Pharmaceuticals, Inc.
CFDA
China Food and Drug Administration
CIT
Chemotherapy-induced thrombocytopenia
CMC
Chemistry, Manufacturing and Controls
Coherus Biosciences
Coherus Biosciences, Inc.
CoM
Composition of Matter
Company
Ligand Pharmaceuticals Incorporated, including subsidiaries
COSO
Committee of Sponsoring Organizations of the Treadway Commission
CRO
Contract Research Organization
CURx
CURx Pharmaceuticals, Inc.
CVR
Contingent value right
CyDex
CyDex Pharmaceuticals, Inc.
Deciphera
Deciphera Pharmaceuticals, LLC
DMF
Drug Master File
EC
European Commission
Eli Lilly
Eli Lilly and Company
EPOR
Erythropoietin receptor
Ethicor
Ethicor Pharmaceuticals, Ltd
EU
European Union
FASB
Financial Accounting Standards Board
FDA
Food and Drug Administration
FSGS
Focal segmental glomerulosclerosis
GCSF
Granulocyte-colony stimulating factor
Hovione
Hovione FarmCiencia
IPR&D
In-Process Research and Development
IRAK-4
Interleukin-1 Receptor Associated Kinase-4
ITP
Chronic immune (idiopathic) thrombocytopenic purpura
IV
Intravenous


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Ligand
Ligand Pharmaceuticals Incorporated, including subsidiaries
LSA
Loan and Security Agreement
LTP
Liver-targeted prodrug
Lundbeck
Lundbeck A/S
MDS
Myelodysplastic syndromes
Melinta
Melinta Therapeutics, Inc.
Merck
Merck & Co., Inc.
Merrimack
Merrimack Pharmaceuticals, Inc.
Millenium
Millenium Pharmaceuticals, Inc. (aka Takeda Oncology)
MLA
Master License Agreement
MRSA
Methicillin-resistant Staphylococcus aureu
NASH
Non-alcoholic steatohepatitis
NDA
New Drug Application
NOLs
Net Operating Losses
Novartis
Novartis AG
OMT
OMT, Inc. or Open Monoclonal Technology, Inc.
Omthera
Omthera Pharmaceuticals, Inc.
Orange Book
Publication identifying drug products approved by the FDA based on safety and effectiveness
Par
Par Pharmaceutical, Inc.
Pfizer
Pfizer Inc.
PPD
Post-Partum Depression
Retrophin
Retrophin Inc.
SAA
Severe Aplastic Anemia
SAGE
Sage Therapeutics, Inc.
SARM
Selective Androgen Receptor Modulator
Sedor
Sedor Pharmaceuticals, Inc., or RODES, Inc.
Selexis
Selexis, SA
Sermonix
Sermonix Pharmaceuticals, LLC
Spectrum
Spectrum Pharmaceuticals, Inc.
SRSE
Super-refractory status epilepticus
Takeda
Takeda Pharmaceuticals Company Limited
T2DM
Type 2 Diabetes Mellitis
TG Therapeutics
TG Therapeutics, Inc.
TPE
Third-party evidence
TR-β
Thyroid hormone receptor beta
VentiRx
VentiRx Pharmaceuticals Inc.
VIE
Variable interest entity
Viking
Viking Therapeutics
X-ALD
X-linked adrenoleukodystrophy
Zydus Cadila
Zydus Cadila Healthcare Ltd



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PART I
 
 
 
Cautionary Note Regarding Forward-Looking Statements:
You should read the following 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 or incorporated by reference.
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 royalties and milestones under license agreements, Capitsol materials sales, and product development, 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.

Trademarks

Our trademarks, trade names and service marks referenced herein include Ligand®, Captisol®, Captisol-enabled, LTP technology, OmniAb®, OmniMouse®, OmniRat® and OmniFlic®. All other trademarks, trade names and service marks including BaxdelaTM, CarnexivTM, Conbriza®, Duavee®, Evomela®,Kyprolis®, Promacta®, Revolade®, SUREtechnology Platform, and Viviant® are the property of their respective owners. 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.


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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 95 pharmaceutical and biotechnology companies, and over 160 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 500 issued patents worldwide, and over 200 currently pending patent applications.
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 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.
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.
2016 Major Business Highlights for Ligand
Acquisitions

Ligand acquired OMT in January 2016, conferring ownership of a large portfolio of licenses and the OmniAb platform, for $173.4 million in cash and stock.
Ligand acquired the economic rights to multiple medical device programs owned by CorMatrix in May 2016. Ligand paid $17.5 million and in return received a portion of revenue (synthetic royalty) from CorMatrix’s existing marketed products and will have the right to receive future synthetic royalties from potential future products.

Late-Stage Clinical Data

On September 7, 2016, Retrophin announced results from the Phase 2 DUET study of sparsentan for the treatment of FSGS, a rare kidney disorder without an FDA-approved pharmacological treatment that often leads to end-stage renal disease. The study achieved statistical significance in the primary efficacy endpoint for the overall sparsentan treatment group, demonstrating a greater than two-fold reduction of proteinuria compared to irbesartan after the eight-week, double-blind treatment period.
On December 6, 2016, Sage announced its expedited development plan for Sage-547 for treatment of postpartum depression, from a breakthrough therapy meeting with the FDA. The current Sage-547 program in PPD, along with prior Phase 2 data, were confirmed as supporting, if successful, a potential NDA. Sage’s PPD clinical program, now in Phase 3, will require only minor modifications, including an increase in sample size.

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Merck announced that it stopped the Phase 2/3 EPOCH study evaluating verubecestat in people with mild-to-moderate Alzheimer’s disease due to the conclusion that the efficacy endpoint could not be achieved. No safety concerns where noted. Results from EPOCH will be analyzed and presented at an upcoming scientific meeting. The external Data Monitoring Committee recommended that the ongoing Phase 3 APECS study, which is evaluating verubecestat in people with prodromal Alzheimer’s disease, continue unchanged. Results from the APECS study are expected in February 2019.

NDA Submissions, Approvals or Label Expansion for Products Ligand is Entitled to Royalties

On March 15, 2016, Spectrum announced that the FDA approved Evomela for use in two indications: as a high dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation (ASCT) in patients with multiple myeloma and for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
On April 7, 2016, the European Commission approved Promacta for the treatment of children one year and above with chronic immune thrombocytopenia who have not responded to other treatments.
On July 3, 2016, Amgen announced that the European Commission approved an expanded indication for Kyprolis®, to be used in combination with dexamethasone alone, for adult patients with multiple myeloma who have received at least one prior therapy.
On July 4, 2016, Ono Pharmaceuticals, holder of Kyprolis marketing rights in Japan, announced approval in Japan for treatment of patients with relapsed or refractory multiple myeloma.
On October 7, 2016, Lundbeck announced approval of Carnexiv IV as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Carnexiv is the first FDA approved intravenous carbamazepine option.
On October 24, 2016, Melinta Therapeutics announced it submitted a NDA for approval of IV Baxdela for the treatment of patients with acute bacterial skin and skin structure infections.
On November 10, 2016, Amgen announced a collaboration with Janssen Biotech, Inc. to evaluate the combination of Amgen's Kyprolis (carfilzomib) and Janssen's DARZALEX® (daratumumab) in multiple clinical studies in patients with multiple myeloma. The first study initiated as part of this agreement is a Phase 3 registrational trial evaluating Kyprolis in combination with DARZALEX and dexamethasone compared to Kyprolis and dexamethasone alone in patients with multiple myeloma who have had one, two or three prior lines of therapy. The study is anticipated to start enrolling patients in April 2017.

Licensing Deals Ligand Entered into or Expanded in 2016

Worldwide platform license agreement with Emergent Biosolutions for access to the OmniAb technology.
Worldwide platform license agreement with Tizona for access to the OmniAb technology.
Worldwide platform license agreement with ABBA Therapeutics for access to the OmniAb technology.
Worldwide platform license agreement with F-Star for access to the OmniAb technology.
Current OmniAb licensee exercised its option to expand access to the OmniAb platform.
Wuxi sublicensed the Chinese rights of two antibodies developed with the OmniAb platform, including to CStone, a Chinese start-up developing an immuno-oncology therapy whose investigational new drug application has been accepted by the CFDA.  The additional antibody is in preclinical development with an undisclosed partner.
Worldwide platform license agreement with Gilead Sciences for access to the OmniAb technology.
Newly formed Nucorion, co-founded by Ligand, licensed three programs utilizing Ligand’s LTP technology and intends to pursue a pipeline of LTP-based programs for China and other markets.
Worldwide license agreement with Teneobio for access to the OmniAb technology.
License agreement of four programs including aplindore, a CRTH2 antagonist program, CE-acetaminophen, and an H3 receptor antagonist program with Seelos Therapeutics.
Worldwide platform license agreement with Ono Pharmaceuticals for access to the OmniAb technology.
Global license and supply agreement with Novartis for the development and commercialization of a CE-oral liquid formulation of trametinib.
License agreement with Beloteca for the development and commercialization of CE-ziprasidone

Internal Pipeline Highlights

Ligand announced that results from two Phase I clinical trials with LGD-6972, the Company’s investigational glucagon receptor antagonist, were published online in the August issue of the journal Diabetes, Obesity and

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Metabolism. The single- and multiple-dose Phase 1a and Phase 1b studies demonstrated favorable safety, tolerability and pharmacokinetics in normal healthy volunteers and in subjects with type 2 diabetes mellitus. The trial results also demonstrate a robust, dose-dependent reduction of fasting plasma glucose.
Ligand announced initiation of a Phase 2 clinical trial with LGD-6972 for the treatment of T2DM. The randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of LGD-6972, as an adjunct to diet and exercise, in subjects with T2DM whose blood glucose levels are inadequately controlled with metformin. Ligand expects to report the results from the Phase 2 clinical trial in the third quarter of 2017.

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 500 issued patents and over 200 pending patent applications.

Captisol Technology

Captisol is Ligand’s 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. Ligand maintains 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. Ligand also filed a DMF in Japan in 2015. Captisol-enabled drugs are marketed in more than 60 countries, and over 45 partners have Captisol-enabled drugs in development.

OmniAb Technologies

In January of 2016, Ligand acquired OMT and the OmniAb Technologies. OmniAb includes three complementary and globally-branded platforms named OmniRat, OmniMouse and OmniFlic. The OmniAb platforms consist of genetically-engineered transgenic rodents 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, streamline development timelines and costs, and accelerate novel antibody discovery. Currently, more than 25 partners are utilizing OmniAb animals in their drug discovery and development efforts

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 partners are utilizing the LTP Technology or related platform(s).

SUREtechnology Platform (owned by Selexis)

Ligand acquired economic rights to over 30 SUREtechnology Platform programs from Selexis in two separate transactions in 2013 and 2015, granting Ligand 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.

CorMatrix products and technologies/programs (owned by CorMatrix)


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Ligand acquired economic rights to multiple programs owned by CorMatrix in May 2016, granting Ligand rights to receive a portion of revenue (synthetic royalty) from CorMatrix’s existing marketed products and rights to future synthetic royalties from potential future products. Ligand receives a share of revenue from the currently marketed vascular, cardiac, and pericardial tissue repair products and the CanGaroo Envelope for cardiac implantable electronic devices. Additionally, Ligand has the rights to receive a share of potential future revenues from CorMatrix’s developmental pipeline products.


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Partners and Licensees
The following table lists our disclosed partners and licensees. In addition to these 83 Companies, we have over 12 additional undisclosed partners and licensees, mostly biotech companies.
Big Pharma
Ticker
 
Generics
Ticker
 
Biotech, continued
Ticker
AstraZeneca
AZN
 
Alvogen
Private
 
Genmab
GEN
Baxter
BAX
 
Avion
Private
 
Genekey Biotech
Private
BMS
BMY
 
BioCad
Private
 
Gilead Sciences
GILD
Daiichi Sankyo
DSKY
 
Coherus
CHRS
 
Hanall
9420
Eli Lilly
LLY
 
Gedeon Richter
GEDSF
 
Harpoon
Private
GSK
GSK
 
IBC Generium
Private
 
Lubris
Private
Janssen
JNJ
 
Oncobiologics
ONS
 
Marinus
MRNS
Merck
MRK
 
Zydus Cadila
CADILAHC
 
MEI
MEIP
Merck KGaA
MRK
 
 
 
 
Melinta
Private
Novartis
NVS
 
Biotech
Ticker
 
Meridian Labs
Private
Otsuka
4768
 
ABBA
Private
 
Millennium
4502
Pfizer
PFE
 
AiCuris
Private
 
Merrimack
MACK
Sanofi
SNY
 
Aldeyra
ALDX
 
Novogen
NVGN
Takeda
4502
 
Amgen
AMGN
 
Nucorion
Private
 
 
 
ARMO
Private
 
Opthea
OPT
Specialty Pharma
Ticker
 
Azure
Private
 
Precision Biologics
Private
CorMatrix
Private
 
bluebird bio
BLUE
 
Retrophin
RTRX
Cuda
Private
 
Cantex
Private
 
ROAR
Private
Gloria
Private
 
Celgene
CELG
 
SAGE
SAGE
Lundbeck
LUN
 
Chiva
Private
 
Seattle Genetics
SGEN
Ono
4528
 
C-Stone
Private
 
Seelos
Private
Sedor
Private
 
CURx
Private
 
Stemcentrx
ABBV
Sermonix
Private
 
Deciphera
Private
 
Symphogen
Private
Shire
SHPG
 
Aptevo
APVO
 
Teneobio
Private
Spectrum
SPPI
 
Exelixis
EXEL
 
Tizona
Private
Teva
TEVA
 
Five Prime
FRPX
 
VentiRx
Private
Vireo Health
Private
 
ForSight Vision
Private
 
Vertex
VRTX
Upsher-Smith
Private
 
F-Star
Private
 
Viking
VKTX
 
 
 
 
 
 
XTL Bio
XTLB
 
 
 
 
 
 
WuXi
Private
 
 
 
 
 
 
 
 








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Portfolio
We have a large portfolio of current and future potential revenue-generating programs, over 155 of which are fully-funded by our partners. In addition to the table below, we also have more than 40 undisclosed programs.
Commercialized
 
 
Phase 2
 
 
Pre-Clinical
 
Alvogen
Voriconazole
 
Aldeyra
ADX-102
 
ABBA
OmniAb
Amgen
Kyprolis
 
Cardioxyl / BMS
BMS986231-CXL-1427
 
Stemcentryx/AbbVie
OmniAb
Baxter
Nexterone
 
Eli Lilly
LY2606368
 
AiCuris GmBH
Undisclosed
CorMatrix Base
CorMatrix
 
Lubris Biopharma
Lubricin
 
Amgen
OmniAb
Cangaroo Envelope
CorMatrix
 
Merrimack Pharma
MM-121
 
Aptevo
OmniAb
Lundbeck
Carnexiv
 
Merrimack Pharma
MM-141
 
ARMO
OmniAb
Merck
Noxafil-IV
 
Millennium/Takeda
MLN-4924
 
Avion
CE programs
Novartis
Promacta
 
Novartis
KLM465
 
Azure
Lasofoxifene
Pfizer
Viviant/Conbriza
 
Opthea Ltd
OPT-302
 
C-Stone
PDL-1
Pfizer
Duavee
 
Precision Biologics
NPC-1C
 
Celgene
OmniAb
Pfizer
Vfend
 
Retrophin
Sparsentan
 
CorMatrix
CorMatrix Pipeline
Spectrum
Evomela
 
Sanofi
SAR125844
 
Cuda Pharma
CE-Propofol
Zydus Cadila
Exemptia
 
Seelos
Aplindore
 
CURx Pharma
IV Lamotrigine
Zydus Cadila
Vivitra
 
Sermonix Pharma
Lasofoxifene
 
Exelixis (BMS)
XL652
 
 
 
Shire
BAX-69
 
Five Prime
OmniAb
Regulatory Submission Stage
 
VentiRx Pharma
VTX-2337
 
F-Star
OmniAb
Biocad
Interferon beta-1a
 
Vertex
VK-970
 
Genmab
OmniAb
Melinta
Baxdela
 
Viking
VK5211
 
Gilead
OmniAb
Sedor
CE-Fosphenytoin
 
Viking
TR Beta
 
Gloria
PD-1 antibody
 
 
 
Viking
VK0612
 
Hanall Biopharma
OmniAb
Phase 3
 
 
XTL Bio
hCDR1
 
Janssen
OmniAb
Biocad
BCD-066
 
 
 
 
Marinus Pharma
Ganaxalone IV
Coherus
CHS-0214
 
Phase 1
 
 
Merck KGaA
OmniAb
Exelixis/Daiichi-Sankyo
CS-3150
 
 
 
 
 
 
Merck
Verubecestat
 
Amgen
AMG-330
 
Merck KGaA
FGFR1
Oncobiologics
ONS-3010
 
Biocad
EPOR Agonist
 
Merck KGaA
LRP-6
Oncobiologics
ONS-1045
 
Chiva Pharma
Pradefovir
 
Nucorion
NUC-101
SAGE
Brexanolone -SAGE-547
 
Chiva Pharma
MB07133
 
Nucorion
NUC-202
 
 
 
CURx Pharma
IV Topiramate
 
Nucorion
NUC-404
Color Legend
 
 
Deciphera Pharma
Altiratinib
 
Omthera/AstraZeneca
LTP-O3FA
Blood Disorders
 
Eli Lilly
LY3023703
 
Oncobiologics
Rituximab
Cardiovascular
 
Eli Lilly
Merestinib
 
Oncobiologics
ONS4010
CNS
 
Eli Lilly
Prexasertib
 
Ono Pharmaceuticals
OmniAb
Infectious Disease
 
Exelixis/Daiichi-Sankyo
XL652
 
Pfizer
OmniAb
Inflamm/Metabolic
 
F-Star
F-102
 
 
 
Severe and Rare
 
Gedeon Richter
RGB-03
 
SAGE
SAGE-689
Cancer
 
Gedeon Richter
Bevacizumab
 
Seattle Genetics
OmniAb
Other / Undisclosed
 
Gedeon Richter
Trastuzumab
 
Sedor
CE-Meloxicam
Medical Device/Cardiology
 
Gilead
GS-5734
 
Seelos
CE-Acetaminophen
 
 
IBC Generium
GNR-008
 
Seelos
CRTH2 Antagonist

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IBC Generium
Deplera
 
Seelos
H3 Receptor Antagonist
 
 
 
MEI Pharma
ME-344
 
Symphogen
OmniAb
 
 
 
MEI Pharma
ME-143
 
Teneobio
OmniAb
 
 
 
Merrimack Pharma
MM-151
 
Teva
OmniAb
 
 
 
Novartis
CE-Trametinib
 
TG Therapeutics
IRAK4
 
 
 
Otsuka
OPC-269
 
Tizona
OmniAb
 
 
 
ROAR Therapeutics
UC-961
 
Upsher Smith
CXCR4
 
 
 
Sedor
CE-Budesonide
 
Viking
EPOR Agonist
 
 
 
Takeda
TAK-020
 
Viking
DGAT-1 Inhibitor
 
 
 
Upsher-Smith
CXCR4
 
Vireo Health
CE-Cannabinoids
 
 
 
VentiRx Pharma
VTX-1463
 
WuXi
OmniAb
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 Ligand 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 three 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) Hepatitis-C associated thrombocytopenia and (3) SAA. 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 three approved indications. Specifically, ITP is currently approved in more than 100 countries, the Hepatitis C-related indication is currently approved in more than 50 countries, and the SAA indication is approved in more than 45 counties.

Beyond the currently-approved indications, Novartis is also performing development activities to expand the brand into new indications, including a number of oncology-related indications including MDS, AML and CIT. As of January 2017, there are 23 open clinical trials related to Promacta (listed as recruiting or open, and not yet recruiting) on the clinicaltrials.gov website.
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 2029, 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.
Kyprolis (Amgen)
Ligand supplies Captisol to Amgen for use with carfilzomib, and granted 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 U.S. for the following:

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In combination with dexamethasone or 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 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. 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 $2 million, revenue from clinical and commercial Captisol material sales and royalties on annual net sales of Kyprolis.

Evomela (Spectrum)

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 future 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.

CorMatrix Portfolio (CorMatrix)
Ligand receives a share of revenue from the currently marketed CorMatrix portfolio of vascular, cardiac and pericardial tissue repair products. In addition, Ligand has the potential to receive a share of revenue and potential milestones from the currently marketed CorMatrix CanGaroo® ECM Envelope for cardiac implantable electronic devices. CorMatrix’s products are medical devices that are designed to permit the development and regrowth of human tissue.
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 registration and worldwide 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.

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Carnexiv (Lundbeck)
Lundbeck's Carnexiv is a Captisol-enabled carbamazepine-IV that was approved by the FDA in October 2016. Carnexiv is indicated as replacement therapy for oral carbamazepine formulations, when oral administration is temporarily no feasible, in adults with certain seizure types. Under the terms of our agreement with Lundbeck, we may be entitled to development and regulatory milestones, royalties on potential future sales by Lundbeck and revenue from Captisol material sales. Lundbeck is responsible for all development costs related to the program.
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.
Exemptia (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.
Vivitra (Zydus Cadila)
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.
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 are considered particularly noteworthy. We are eligible to receive milestone payments and royalties off of 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 Overview section. In the case of Captisol-related programs, we are also eligible to receive revenue for the sale of Captisol material supply.
Baxdela (Melinta)
Our partner, Melinta , submitted an NDA for approval of a Captisol-enabled delafloxacin-IV in October 2016 for the development of Baxdela, a Captisol-enabled delafloxacin-IV. Delafloxacin is a novel hospital-focused fluoroquinolone antibiotic candidate with potency 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 up to $2.1 million of development and regulatory milestones, as well as a royalty on potential future sales by Melinta, and revenue from Captisol material sales. Melinta is responsible for all development costs related to the program.

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Brexanolone-SAGE-547 (SAGE)
    Our partner, SAGE, is conducting a Phase 3 clinical trial for the development of Captisol-enabled therapeutics for a broad range of debilitating central nervous system conditions. SAGE’s lead clinical program, Captisol-enabled Brexanolone (SAGE-547), is an allosteric modulator of both synaptic and extra-synaptic GABAA receptors that is in clinical development as an adjunctive therapy, a therapy combined with current therapeutic approaches, for the treatment of SRSE. Brexanolone was granted Fast Track designation, which is intended to facilitate the development and expedite the review of drug candidates that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs, and orphan drug designation, which is intended to facilitate drug development for rare diseases, by the FDA for SRSE. Ligand has 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.
SAGE is also conducting a Phase 3 clinical trial for the development of a Captisol-enabled treatment of PPD. In July 2016 SAGE reported top-line results from a Phase 2 placebo-controlled trial in women with severe PPD, in which SAGE-547 achieved a significant, rapid and durable reduction in depression scores. SAGE received Breakthrough Therapy Designation from the FDA for SAGE-547 in PPD in September, 2016. The Breakthrough Therapy Designation is intended to offer a potentially expedited development path and review for promising drug candidates, which includes increased interaction and guidance from the FDA.
Sparsentan (Retrophin)
Our partner, Retrophin, is developing sparsentan for orphan indications of severe kidney diseases, and has completed a Phase 2 clinical trial of sparsentan for the treatment of FSGS. Certain patient groups with severely compromised renal function, including those with FSGS, 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. In January 2015, the FDA granted sparsentan orphan drug designation.
Under our license agreement with Retrophin we are entitled to receive potential net milestones of over $75 million in the future 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 Captisol-enabled LY2606368 (Chk 1/2 inhibitor) for 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.
CXL-1427 - BMS986231 (Cardioxyl /BMS)
Our partner, Cardioxyl (acquired by BMS in 2015) is conducting Phase 2 clinical trials for Captisol-enabled CXL-1427 (nitroxyl donor prodrug) for 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.
Lasofoxifene (Azure Biotech, and Sermonix)
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.
Lasofoxifene is an estrogen partial agonist 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.

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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 up to $45 million in potential regulatory and commercial milestone payments as well as royalties on future net sales.
Verubecestat-MK-8931 (Merck)
Our partner, Merck is developing Verubecestat (MK-8931), a BACE inhibitor for the treatment of Alzheimer’s disease. Alzheimer’s disease is a chronic neurodegenerative disease and responsible for the majority of dementia cases. The leading hypothesis in the field postulates that plaques of amyloid-beta protein within the brain are the main cause of the disease. BACE is a key enzyme in the production of amyloid-beta protein and a BACE inhibitor is expected to reduce amyloid-beta protein generation in Alzheimer’s disease patients to prevent plaques formation. Verubecestat is the leading BACE inhibitor in clinic. In February 2017, Merck halted the first Phase 3 trial in mild-to-moderate Alzheimer’s disease for futility and expects initial data readout from the second Phase 3 trial in prodromal Alzheimer’s disease in 2019.  It is hoped that by attacking amyloid-beta plaque earlier in the disease, Verubecestat can still be effective. We are entitled to a royalty on potential future sales by Merck.  Merck is responsible for all development costs related to the program
TR-Beta - VK2809 (Viking)
Viking is developing VK2809, a novel selective TR-Beta agonist with potential in multiple indications, including hypercholesterolemia, dyslipidemia, NASH, and X-ALD. Viking initiated a Phase 2 trial for VK2809 in hypercholesterolemia and fatty liver disease in 2016 and expects primary outcome readout this year. 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.
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 initiated a Phase 2 trial in hip fracture in 2015. 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.
Merestinib- LY2801653 (Eli Lilly)
Our partner, Eli Lilly is conducting Phase 2 clinical trials for Captisol-enabled merestinib (LY2801653, formerly known as 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 - MLN-4924 (Millennium/Takeda)
Our partner, Millennium/Takeda is currently conducting Phase 2 trials for the development of pevonedistat (MLN-4924) 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.
Motolimod - VTX-2337 (VentiRx Pharmaceuticals/Celgene)
Our partner, VentiRx is currently conducting Phase 2 trials for the development of motolimod for the treatment of ovarian cancer and head and neck cancer. Motolimod is a Captisol-enabled Toll-like Receptor 8 agonist. Motolimod was granted Fast Track and Orphan Designations by the FDA for the treatment of recurrent or persistent ovarian cancer. VentiRx has an exclusive worldwide collaboration with Celgene to develop motolimod. Under the terms of the clinical-stage agreement, we have earned development milestones from VentiRx and revenue from Captisol material sales.
Seribantumab-MM-121 (Merrimack Pharmaceuticals)
Merrimack Pharmaceuticals is currently conducting a Phase 2 trial of seribantumab (MM-121) in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer whose disease has progressed following immunotherapy. The FDA has granted fast track designation to facilitate and expedite the development. Seribantumab is

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an antibody-drug that targets ErbB3 that was developed using the Selexis SUREtechnology Platform. Under the terms of the agreement, we may be entitled to development and commercial milestones, royalties on potential future sales.
CHS-0214 (Coherus Biosciences)
Coherus Biosciences has conducted Phase 3 / MAA-enabling clinical trials for CHS-0214 (etanercept biosimilar) for rheumatoid arthritis and psoriasis. Coherus uses the Selexis’ technology platform for CHS-0214. We are entitled to earn regulatory and sales milestones, and royalties on potential future sales through at least 2026.
AM0010+PD-1 (ARMO Biosciences)
Our partner, ARMO Biosciences, is developing an anti-PD-1 antibody discovered with the OmniAb platform technology.  AM0010+PD-1 is a therapeutic target for cancer therapy.  We are entitled to earn regulatory milestones and royalties on future sales.
ADX-102 (Aldeyra)
              Our partner, Aldeyra, is conducting a phase II study for ADX-102 for the treatment of ocular inflammation.  ADX-102 is a Captisol-enabled ophthalmic solution for the treatment of allergic conjunctivitis that could be active in a broad array of inflammatory ocular diseases.  Under the terms of our agreement with Aldeyra, we are entitled to receive regulatory milestones and royalties on future sales.
Esaxerenone (Exelixis)
              Our partner, Exelixis, entered into a collaboration agreement with Daiichi Sankyo and is conducting a phase 3 pivotal trial (ESAX-HTN) to evaluate esaxerenone (CS-3150) versus eplerenone for essential hypertension in Japanese patients.  Under the terms of the agreement with Exelixis, we are entitled to receive a royalty on future sales.
TAK-020 (Takeda)
              Our partner, Takeda, is conducting a phase I study for TAK-020 for the treatment of rheumatoid arthritis.  TAK-020 is a Captisol-enabled formulation.  We have received an up front fee and revenue from Captisol material sales.
The following table represents our various royalty arrangements:
Royalty Table
Ligand Licenses With Tiered Royalties, Tiers Disclosed*
Promacta (Novartis)
 
Kyprolis (Amgen)
 
Duavee (Pfizer)
 
Viviant/Conbriza (Pfizer)
< $100 million
4.7%
 
< $250 million
1.5%
 
<$400 million
0.5%
 
<$400 million
0.5%
$100 to $200 million
6.6%
 
$250 to $500 million
2.0%
 
$400 million to $1.0 billion
1.5%
 
$400 million to $1.0 billion
1.5%
$200 to $400 million
7.5%
 
$500 to $750 million
2.5%
 
>$1.0 billion
2.5%
 
>$1.0 billion
2.5%
$400 million to $1.5 billion
9.4%
 
>$750 million
3.0%
 
 
 
 
 
 
>$1.5 billion
9.3%
 
 
 
 
 
 
 
 
 
CE-Topiramate (CURx)
 
CE-Budesonide (Sedor)
 
CE-Meloxicam (Sedor)
< $50 million
6.0%
 
< $25 million
8.0%
 
< $25 million
8.0%
$50 to $100 million
6.8%
 
> $25 million
10.0%
 
> $25 million
10.0%
>$100 million
7.5%
 
 
 
 
 
 

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Ligand Licenses With Tiered Royalties, Tiers Undisclosed*
Program
Licensee
Royalty Rate
IRAK4
TG Therapeutics
6.0% - 9.5%
CE-Lamotrigine
CURx
4.0% - 7.0%
Lasofoxifene
Sermonix
6.0% - 10.0%
FBPase Inhibitor
Viking
7.5% - 9.5%
SARM
Viking
7.25% - 9.25%
TR Beta
Viking
3.5% - 7.5%
Oral EPO
Viking
4.5% - 8.5%
DGAT-1
Viking
3.0% - 7.0%
LTP-O3FA
Omthera/AstraZeneca
Tiered mid-to-high single digit royalties
Various
Nucorion
4.0%-9.0%
Various
Seelos
4.0%-10.0%
Ligand Licenses With Fixed Royalties*
Program
Licensee
Royalty Rate
Evomela
Spectrum Pharma
20%
Baxdela
Melinta
2.5%
SAGE-547
SAGE
3%
Sparsentan
Retrophin
9%
CE-Fosphenytoin
Sedor
11%
Pradefovir
Chiva Pharma
9%
MB07133
Chiva Pharma
6%
KLM465
Novartis
14.5% (6.5% in year one)
Topical lasofoxifene
Azure Biotech
5%
MM-121
Merrimack Pharma
<1.0%
MM-151
Merrimack Pharma
<1.0%
MM-141
Merrimack Pharma
<1.0%
ME-143
MEI Pharma
Low single digit royalty
ME-344
MEI Pharma
Low single digit royalty
ADX-102
Aldeyra Therapeutics
Low single 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.

Primary Internal Development Program - Glucagon Receptor Antagonist Program

We are currently developing a small molecule glucagon receptor antagonist for the treatment of Type 2 diabetes mellitus. Compounds that block the action of glucagon may reduce the hyperglycemia that is characteristic of the disease. Glucagon stimulates the production of glucose by the liver and its release into the blood stream. In diabetic patients, glucagon secretion is abnormally elevated and contributes to hyperglycemia in these patients. We announced results in 2016 from two Phase I clinical trials which demonstrated favorable safety, tolerability and pharmacokinetics in normal healthy volunteers and in subjects with type 2 diabetes mellitus. The trial results also demonstrate a robust, dose-dependent reduction of fasting plasma glucose. We also initiated a Phase 2 clinical trial in September 2016 for the treatment of type 2 diabetes mellitus (T2DM). The randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of LGD-6972, as an adjunct to diet and exercise, in subjects with T2DM whose blood glucose levels are inadequately controlled with metformin.

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The following table represents other internal programs eligible for further development funding, either through Ligand or a partner:
Program
 
Development Stage
 
Indication
CCR1 Antagonist
 
Preclinical
 
Oncology
CE-Busulfan
 
Preclinical
 
Oncology
CE-Cetirizine Injection
 
Preclinical
 
Allergy
CE-Clopidogrel
 
Phase 3
 
Anti-coagulant
CE-Sertraline, Oral Concentrate
 
Phase 1
 
Depression
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
Manufacturing
We currently have no manufacturing facilities and rely on a third party, 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 in both of Hovione's Portugal and Ireland sites with distribution operations also performed from Hovione's Portugal and Ireland sites.
We have ongoing minimum purchase commitments under the agreement and are required to pay Hovione an aggregate minimum amount during the agreement term.
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 or if the unit price of Captisol exceeds a set figure, we may obtain Captisol from a third party.
The current term of the agreement with Hovione is through December 2019. 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. 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 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.
Existing or potential competitors to our licensee’s products, particularly large pharmaceutical companies, may have greater financial, technical and human resources than our licensees. Accordingly, these competitors may be better equipped to develop, manufacture and market products. Many of these companies also have extensive experience in preclinical testing and human clinical trials, obtaining FDA and other regulatory approvals and manufacturing and marketing pharmaceutical products.
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.

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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.”
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 has been granted due to pediatric studies conducted by GSK. The type of patent protection (e.g., composition of matter or use) for each patent listed in the Orange Book and the expiration date 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.


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Promacta
United States
Corresponding Foreign
Type of Protection
U.S. Patent No.
U.S. Expiration Date
Jurisdiction
Patent Number
Expiration Date‡
CoM / Use
6,280,959
10/30/2018
N/A
 
 
CoM / Use
7,160,870
11/20/2022
EU
1,864,981
5/24/2021
EU
1,294,378
5/24/2021
Japan
3,813,875
5/24/2021
Use
7,332,481
5/24/2021
EU
1,889,838
5/24/2021
Japan
4,546,919
5/24/2021
CoM / Use
7,452,874
5/24/2021
EU
1,889,838
5/24/2021
Japan
4,546,919
5/24/2021
CoM / Use
7,473,686
5/24/2021
EU
1,864,981
5/24/2021
EU
1,294,378
5/24/2021
Japan
3,813,875
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
N/A
 
 
Use
7,795,293
5/21/2023
N/A
 
 
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
CoM / Use
8,052,994
8/1/2027
EU
2,152,237
8/1/2027
Japan
5,419,866
8/1/2027
Japan
5,735,078
8/1/2027
CoM / Use
8,052,995
8/1/2027
EU
2,152,237
8/1/2027
Japan
5,419,866
8/1/2027
Japan
5,735,078
8/1/2027
CoM / Use
8,062,665
8/1/2027
EU
2,152,237
8/1/2027
Japan
5,419,866
8/1/2027
Japan
5,735,078
8/1/2027
CoM / Use
8,071,129
8/1/2027
EU
2,152,237
8/1/2027
Japan
5,419,866
8/1/2027
Japan
5,735,078
8/1/2027
CoM / Use
8,828,430
8/1/2027
EU
2,152,237
8/1/2027
Japan
5,419,866
8/1/2027
Japan
5,735,078
8/1/2027


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.
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. 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.


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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
EU
1,745,064
4/14/2025
Japan
5,394,423
4/14/2025
CoM
7,417,042
7/20/2026
EU
1,781,688
8/8/2025
Japan
4,743,720
8/8/2025
Use
7,491,704
4/14/2025
EU
1,745,064
4/14/2025
Japan
5,394,423
4/14/2025
CoM
7,737,112
12/7/2027
EU
1,819,353
12/7/2025
EU
2,260,835
12/7/2025
EU
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
EU
1,745,064
4/14/2025
Japan
5,394,423
4/14/2025
CoM
8,207,125
4/14/2025
EU
1,781,688
8/8/2025
Japan
4,743,720
8/8/2025
CoM / Use
8,207,126
4/14/2025
N/A
 
 
Use
8,207,127
4/14/2025
N/A
 
 
CoM / Use
8,207,297
4/14/2025
N/A
 
 
Use
9,511,109
10/21/2029
Japan
5,675,629
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 are owned by us. Other patents and pending patent applications covering methods of making Captisol are owned by Ligand or by Pfizer. 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)). 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.


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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
3/19/2028
EU
2,708,225
pending
Japan
2015-163634
pending
CoM
7,629,331
10/26/2025
EU
1,945,228
10/26/2025
EU
2,335,707
10/26/2025
EU
2,581,078
10/26/2025
Use
8,049,003
12/19/2026
EU
2,583,668
10/26/2025
CoM
8,846,901
10/26/2025
EU
1,945,228
10/26/2025
EU
2,335,707
10/26/2025
EU
2,581,078
10/26/2025
CoM
8,829,182
10/26/2025
EU
1,945,228
10/26/2025
EU
2,335,707
10/26/2025
EU
2,581,078
10/26/2025
CoM / Use
7,635,773
3/13/2029
EU
2,268,269
pending
Japan
4,923,144
4/28/2029
Japan
6,039,721
4/28/2029
 
 
 
Japan
2016-216021
pending
CoM
8,410,077
3/13/2029
EU
2,268,269
pending
Japan
4,923,144
4/28/2029
Japan
6,039,721
4/28/2029
 
 
 
Japan
2016-216021
pending
CoM
9,200,088
3/13/2029
EU
2,268,269
pending
Japan
4,923,144
4/28/2029
Japan
6,039,721
4/28/2029
 
 
 
Japan
2016-216021
pending
CoM
9,493,582
2/27/2033
EU
2,748,205
pending
 
 
 
Japan
2016-166368
pending
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
Ligand has received patent protection in 27 countries, including the United States, multiple countries throughout Europe, Japan and China (see selected cases listed in the table below) and has 19 patent applications pending worldwide. The patents and applications owned by Ligand are expected to expire between 2028 and 2033 and partners are able to use the OMT patented technology to generate novel antibodies, which may be entitled to additional patent protection.



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OmniAb
United States
Corresponding Foreign
Type of Protection
U.S. Patent No.
U.S. Expiration Date
Jurisdiction
Patent Number
Expiration Date‡
 
 
 
EU
2,152,880
5/30/2028
 
 
 
EU
2,336,329
5/30/2028
CoM
8,703,485
10/10/2031
Japan
5,823,690
5/30/2028
 
9,388,233
5/30/2028
N/A
 
 
Use
8,907,157
5/30/2028
N/A
 
 
CoM / Use
9,475,859
4/15/2034
N/A
 
 
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.
LTP Technology
Patent applications related to our LTP Technology include two families owned by Ligand and one owned by Omthera. Each of these patent families include claims directed to composition of matter and use. Patents resulting from these applications, if granted, would have a latest expiration date in 2036.
LGD-6972 (Glucagon Receptor Antagonist)
Patents and pending patent applications covering LGD-6972 are owned by Ligand. Patents covering LGD-6972, if issued, with the latest expiration date would not be set to expire until 2035 (see, e.g., WO 2015/191900 (contains composition of matter and use claims; filed June 11, 2015)). The type of patent protection (e.g., composition of matter or use) and the expiration dates for several issued patents covering LGD-6972 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.
LGD-6972
United States
Corresponding Foreign
Type of Protection
U.S. Patent No.
U.S. Expiration Date
Jurisdiction
Patent Number
Expiration Date‡
CoM
8,710,236
2/11/2028
EU
2,129,654
2/11/2028
EU
2,786,985
pending
Japan
5,322,951
2/11/2028
Japan
2015-196171
pending
CoM
9,169,201
2/11/2028
EU
2,129,654
2/11/2028
EU
2,786,985
pending
Japan
5,322,951
2/11/2028
Japan
2015-196171
pending
CoM / Use
8,907,103
1/2/2031
EU
2,326,618
8/13/2029
EU
2,799,428
8/13/2029
EU
n/a
pending
Japan
5,684,126
8/13/2029
Japan
2016-251460
pending
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.
Human Resources
As of February 6, 2016, we had 22 full-time employees, of whom eight are involved directly in scientific research and development activities.


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Investor Information
Financial and other information about us is available on our website at www.ligand.com. We make available on our website copies of our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish it to, the U.S. Securities and Exchange Commission (SEC). In addition, we have previously filed registration statements and other documents with the SEC. Any document we file may be inspected, at the SEC’s public reference room at 100 F Street NE, Washington, DC 20549, or at the SEC’s internet address at www.sec.gov. These website addresses are not intended to function as hyperlinks, and the information contained in our website and in the SEC’s website is not intended to be a part of this filing. Information related to the operation of the SEC’s public reference room may be obtained by calling the SEC at 800-SEC-0330.

ITEM 1A.
RISK FACTORS
The following is a summary description of some of the many risks we face in our business. You should carefully review these risks in evaluating our business, including the businesses of our subsidiaries. You should also consider the other information described in this report.

Future revenue based on Promacta, Kyprolis and Evomela, as well as sales of our other products, may be lower than expected.

Novartis is obligated to pay us royalties on its sales of Promacta, and we receive revenue from Amgen based on both sales of Kyprolis and purchases of Captisol material for clinical and commercial uses. These payments are expected to be a substantial portion of our ongoing revenues for some time. In addition, we receive revenues based on sales of Evomela and other products. Any setback that may occur with respect to any of our partners' products, and in particular Promacta or Kyprolis, could significantly impair our operating results and/or reduce our revenue and the market price of our stock. Setbacks for the products could include problems with shipping, distribution, manufacturing, product safety, marketing, government regulation or reimbursement, licenses and approvals, intellectual property rights, competition with existing or new products and physician or patient acceptance of the products, as well as higher than expected total rebates, returns, discounts, or unfavorable exchange rates. These products also are or may become subject to generic competition.

Future revenue from sales of Captisol material to our license partners may be lower than expected.

Revenues from sales of Captisol material to our collaborative partners represent a significant portion of our current revenues. Any setback that may occur with respect to Captisol could significantly impair our operating results and/or reduce the market price of our stock. Setbacks for Captisol could include problems with shipping, distribution, manufacturing, product safety, marketing, government regulation or reimbursement, licenses and approvals, intellectual property rights, competition with existing or new products and physician or patient acceptance of the products using Captisol.

If products or product candidates incorporating Captisol material were to cause any unexpected adverse events, the perception of Captisol safety could be seriously harmed. If this were to occur, we may not be able to sell Captisol unless and until we are able to demonstrate that the adverse event was unrelated to Captisol, which we may not be able to do. Further, the FDA could require us to submit additional information for regulatory review or approval, including data from extensive safety testing or clinical testing of products using Captisol. This would be expensive and it may delay the marketing of Captisol-enabled products and receipt of revenue related to those products, which could significantly impair our operating results and/or reduce the market price of our stock.

We obtain Captisol from a sole source supplier, and if this supplier were to cease to be able, for any reason, to supply Captisol to us in the amounts we require, or decline to supply Captisol to us, we would be required to seek an alternative source, which could potentially take a considerable length of time and impact our revenue and customer relationships. We maintain inventory of Captisol, which has a five year shelf life, at three geographically dispersed storage locations in the United States and Europe.  If we were to encounter problems maintaining our inventory, such as natural disasters, at one or more of these locations, it could lead to supply interruptions.

We currently depend on our arrangements with our partners and licensees to sell products using our Captisol technology. These agreements generally provide that our partners may terminate the agreements at will. If our partners discontinue sales of

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products using Captisol, fail to obtain regulatory approval for products using Captisol, fail to satisfy their obligations under their agreements with us, or choose to utilize a generic form of Captisol should it become available, or if we are unable to establish new licensing and marketing relationships, our financial results and growth prospects would be materially affected. Furthermore, we maintain significant accounts receivable balances with certain customers purchasing Captisol materials, which may result in the concentration of credit risk. We generally do not require any collateral from our customers to secure payment of these accounts receivable. If any of our major customers were to default in the payment of their obligations to us, our business, operating results and cash flows could be adversely affected.

Further, under most of our Captisol outlicenses, the amount of royalties we receive will be reduced or will cease when the relevant patent expires. Our low-chloride patents and foreign equivalents are not expected to expire until 2033, our high purity patents and foreign equivalents, are not expected to expire until 2029 and our morphology patents and foreign equivalents, are not expected to expire until 2025, but the initially filed patents relating to Captisol expired starting in 2010 in the United States and in 2016 in most countries outside the United States. If our other intellectual property rights are not sufficient to prevent a generic form of Captisol from coming to market and if in such case our partners choose to terminate their agreements with us, our Captisol revenue may decrease significantly.

Third party intellectual property may prevent us or our partners from developing our potential products; our and our partners’ intellectual property may not prevent competition; and any intellectual property issues may be expensive and time consuming to resolve.

The manufacture, use or sale of our potential products or our licensees' products or potential products may infringe the patent rights of others. If others obtain patents with conflicting claims, we may be required to obtain licenses to those patents or to develop or obtain alternative technology. We may not be able to obtain any such licenses on acceptable terms, or at all. Any failure to obtain such licenses could delay or prevent us from pursuing the development or commercialization of our potential products.

Generally, our success will depend on our ability and the ability of our partners to obtain and maintain patents and other intellectual property rights for our and their potential products.  Our patent position is uncertain and involves complex legal and technical questions for which legal principles are unresolved.  Even if we or our partners do obtain patents, such patents may not adequately protect the technology we own or have licensed.  For example, in January 2016, we received a paragraph IV certification from a subsidiary of Par advising us that it had filed an ANDA with the FDA seeking approval to market a generic version of Merck’s NOXAFIL-IV product.  The paragraph IV certification alleges that Merck’s U.S. Patent No. 9,023,790 related to NOXAFIL-IV and our U.S. Patent No. 8,410,077 related to Captisol, which we refer to as the ‘077 Patent, are invalid and/or will not be infringed by Par’s manufacture, use or sale of the product for which the ANDA was submitted. Although Merck and Par settled this dispute, we could face similar disputes in the future which, if successful, could result in lost revenues or limit our ability to enter into new licenses using the challenged patent.
 
Any conflicts with the patent rights of others could significantly reduce the coverage of our patents or limit our ability to obtain meaningful patent protection. For example, our European patent related to Agglomerated forms of Captisol was limited during an opposition proceeding, and the rejection of our European patent application related to High Purity Captisol is currently being appealed. In addition, any determination that our patent rights are invalid may result in early termination of our agreements with our license partners and could adversely affect our ability to enter into new license agreements. We also rely on unpatented trade secrets and know-how to protect and maintain our competitive position. We require our employees, consultants, licensees and others to sign confidentiality agreements when they begin their relationship with us. These agreements may be breached, and we may not have adequate remedies for any breach. In addition, our competitors may independently discover our trade secrets.

We may also need to initiate litigation, which could be time-consuming and expensive, to enforce our proprietary rights or to determine the scope and validity of others' rights. If this occurs, a court may find our patents or those of our licensors invalid or may find that we have infringed on a competitor's rights. In addition, if any of our competitors have filed patent applications in the United States which claim technology we also have invented, the United States Patent and Trademark Office may require us to participate in expensive interference proceedings to determine who has the right to a patent for the technology.

The occurrence of any of the foregoing problems could be time-consuming and expensive and could adversely affect our financial position, liquidity and results of operations.


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We rely heavily on licensee relationships, and any disputes or litigation with our partners or termination or breach of any of the related agreements could reduce the financial resources available to us, including milestone payments and future royalty revenues.

Our existing collaborations may not continue or be successful, and we may be unable to enter into future collaborative arrangements to develop and commercialize our unpartnered assets. Generally, our current collaborative partners also have the right to terminate their collaborations at will or under specified circumstances. If any of our collaborative partners breach or terminate their agreements with us or otherwise fail to conduct their collaborative activities successfully (for example, by not making required payments when due, or at all), our product development under these agreements will be delayed or terminated. Disputes or litigation may also arise with our collaborators (with us and/or with one or more third parties), including those over ownership rights to intellectual property, know-how or technologies developed with our collaborators. For example, we are asserting our rights to receive payment against one of our collaborative partners which could harm our relationship with sch partner. Such disputes or litigation could adversely affect our rights to one or more of our product candidates and could delay, interrupt or terminate the collaborative research, development and commercialization of certain potential products, create uncertainty as to ownership rights of intellectual property, or could result in litigation or arbitration. In addition, a significant downturn or deterioration in the business or financial condition of our collaborators or partners could result in a loss of expected revenue and our expected returns on investment. The occurrence of any of these problems could be time-consuming and expensive and could adversely affect our business.

Our product candidates, and the product candidates of our partners, face significant development and regulatory hurdles prior to partnering and/or marketing which could delay or prevent licensing, sales-based royalties and/or milestone revenue.

Before we or our partners obtain the approvals necessary to sell any of our unpartnered assets or partnered programs, we must show through preclinical studies and human testing that each potential product is safe and effective. We and/or our partners have a number of partnered programs and unpartnered assets moving toward or currently awaiting regulatory action. Failure to show any product's safety and effectiveness could delay or prevent regulatory approval of a product and could adversely affect our business. The drug development and clinical trials process is complex and uncertain. For example, the results of preclinical studies and initial clinical trials may not necessarily predict the results from later large-scale clinical trials. In addition, clinical trials may not demonstrate a product's safety and effectiveness to the satisfaction of the regulatory authorities. A number of companies have suffered significant setbacks in advanced clinical trials or in seeking regulatory approvals, despite promising results in earlier trials. The FDA may also require additional clinical trials after regulatory approvals are received. Such additional trials may be expensive and time-consuming, and failure to successfully conduct those trials could jeopardize continued commercialization of a product.

The speed at which we and our partners complete our scientific studies and clinical trials depends on many factors, including, but not limited to, our ability to obtain adequate supplies of the products to be tested and patient enrollment. Patient enrollment is a function of many factors, including the size of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the trial and other potential drug candidates being studied. Delays in patient enrollment for our or our partners’ trials may result in increased costs and longer development times. In addition, our partners have rights to control product development and clinical programs for products developed under our collaborations. As a result, these partners may conduct these programs more slowly or in a different manner than expected. Moreover, even if clinical trials are completed, we or our partners still may not apply for FDA approval in a timely manner or the FDA still may not grant approval.

Our drug development programs may require substantial additional capital to complete successfully, arising from costs to: conduct research, preclinical testing and human studies; establish pilot scale and commercial scale manufacturing processes and facilities; and establish and develop quality control, regulatory, marketing, sales and administrative capabilities to support these programs. While we expect to fund our research and development activities from cash generated from operations to the extent possible, if we are unable to do so, we may need to complete additional equity or debt financings or seek other external means of financing. These financings could depress our stock price. If additional funds are required to support our operations and we are unable to obtain them on terms favorable to us, we may be required to cease or reduce further development or commercialization of our products, to sell some or all of our technology or assets or to merge with another entity.

Our OmniAb antibody platform faces specific risks, including the fact that no drug using antibodies from the platform has yet advanced to late stage clinical trials.

None of our collaboration partners using our OmniAb antibody platform have tested drugs based on the platform in clinical trials and, therefore, none of our OmniAb collaboration partners’ drugs have received FDA approval. If one of our OmniAb collaboration partners’ drug candidates fails during preclinical studies or clinical trials, our other OmniAb collaboration partners may decide to abandon drugs using antibodies generated from the OmniAb platform, whether or not

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attributable to the platform. All of our OmniAb collaboration partners may terminate their programs at any time without penalty. In addition, our OmniRat and OmniFlic platforms, which we consider the most promising, are covered by two patents within the U.S. and two patents in the European Union and are subject to the same risks as our patent portfolio discussed above, including the risk that our patents may infringe on third party patent rights or that our patents may be invalidated. Further, we face significant competition from other companies selling human antibody-generating rodents, especially mice which compete with our OmniMouse platform, including the VelocImmune mouse, the AlivaMab mouse, the Trianni mouse and the Kymouse. Many of our competitors have greater financial, technical and human resources than we do and may be better equipped to develop, manufacture and market competing antibody platforms.

If plaintiffs bring product liability lawsuits against us or our partners, we or our partners may incur substantial liabilities and may be required to limit commercialization of our approved products and product candidates.

As is common in our industry, our partners and we face an inherent risk of product liability as a result of the clinical testing of our product candidates in clinical trials and face an even greater risk for commercialized products. Although we are not currently a party to product liability litigation, if we are sued, we may be held liable if any product or product candidate we develop causes injury or is found otherwise unsuitable during product testing, manufacturing, marketing or sale. Regardless of merit or eventual outcome, liability claims may result in decreased demand for any product candidates or products that we may develop, injury to our reputation, discontinuation of clinical trials, costs to defend litigation, substantial monetary awards to clinical trial participants or patients, loss of revenue and the inability to commercialize any products that we develop. We have product liability insurance that covers our clinical trials up to a $10.0 million annual limit. If we are sued for any injury caused by our product candidates or any future products, our liability could exceed our total assets.

Any difficulties from strategic acquisitions could adversely affect our stock price, operating results and results of operations.

We may acquire companies, businesses and products that complement or augment our existing business. We may not be able to integrate any acquired business successfully or operate any acquired business profitably. Integrating any newly acquired business could be expensive and time-consuming. Integration efforts often take a significant amount of time, place a significant strain on managerial, operational and financial resources and could prove to be more difficult or expensive than we predict. The diversion of our management's attention and any delay or difficulties encountered in connection with any future acquisitions we may consummate could result in the disruption of our on-going business or inconsistencies in standards and controls that could negatively affect our ability to maintain third-party relationships. Moreover, we may need to raise additional funds through public or private debt or equity financing, or issue additional shares, to acquire any businesses or products, which may result in dilution for stockholders or the incurrence of indebtedness.

As part of our efforts to acquire companies, business or product candidates or to enter into other significant transactions, we conduct business, legal and financial due diligence with the goal of identifying and evaluating material risks involved in the transaction. Despite our efforts, we ultimately may be unsuccessful in ascertaining or evaluating all such risks and, as a result, might not realize the intended advantages of the transaction. If we fail to realize the expected benefits from acquisitions we may consummate in the future or have consummated in the past, whether as a result of unidentified risks, integration difficulties, regulatory setbacks, litigation with current or former employees and other events, our business, results of operations and financial condition could be adversely affected. If we acquire product candidates, we will also need to make certain assumptions about, among other things, development costs, the likelihood of receiving regulatory approval and the market for such product candidates. Our assumptions may prove to be incorrect, which could cause us to fail to realize the anticipated benefits of these transactions.

In addition, we will likely experience significant charges to earnings in connection with our efforts, if any, to consummate acquisitions. For transactions that are ultimately not consummated, these charges may include fees and expenses for investment bankers, attorneys, accountants and other advisors in connection with our efforts. Even if our efforts are successful, we may incur, as part of a transaction, substantial charges for closure costs associated with elimination of duplicate operations and facilities and acquired IPR&D charges. In either case, the incurrence of these charges could adversely affect our results of operations for particular quarterly or annual periods.

We have restated prior consolidated financial statements, which may lead to possible additional risks and uncertainties, including possible loss of investor confidence.

We have restated our consolidated financial statements as of and for the year ended December 31, 2015 (including the third quarter within that year) and for the first and second quarters of fiscal year 2016 in order to correct certain accounting errors. For a description of the material weaknesses in our internal control over financial reporting identified by management in

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connection with the Restatement and management’s plan to remediate those material weaknesses, see “Part II, Item 9A - Controls and Procedures.”

As a result of the Restatement, we have become subject to possible additional costs and risks, including (a) accounting and legal fees incurred in connection with the Restatement and (b) a possible loss of investor confidence. Further, we are subject to a shareholder lawsuit related to the Restatement which may be costly to defend and divert our management's attention from other operating matters. See "Item 3. Legal Proceedings."
We have identified material weaknesses in our internal control over financial reporting that, if not remediated, could result in additional material misstatements in our financial statements.
As described in “Part II, Item 9A - Controls and Procedures,” management identified control deficiencies that represent material weaknesses. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. As a result of the identified material weaknesses, management has concluded that we did not maintain effective internal control over financial reporting as of December 31, 2016. See “Part II, Item 9A - Controls and Procedures.”

We are developing and implementing a remediation plan to address the material weaknesses. If our remediation efforts are insufficient or if additional material weaknesses in our internal control over financial reporting are discovered or occur in the future, our consolidated financial statements may contain material misstatements and we could be required to restate our financial results, which could materially and adversely affect our business, results of operations and financial condition, restrict our ability to access the capital markets, require us to expend significant resources to correct the material weakness, subject us to fines, penalties or judgments, harm our reputation or otherwise cause a decline in investor confidence.

Changes or modifications in financial accounting standards, including those related to revenue recognition, may harm our results of operations.

From time to time, the Financial Accounting Standards Board, or FASB, either alone or jointly with other organizations, promulgates new accounting principles that could have an adverse impact on our results of operations. For example, in May 2014, FASB issued a new accounting standard for revenue recognition-Accounting Standards Codification Topic 606, Revenue from Contracts with Customers, or ASC 606-that supersedes most current revenue recognition guidance. The new guidance requires a company to recognize revenue upon transfer of goods or services to a customer at an amount that reflects the expected consideration to be received in exchange for those goods or services. The new guidance becomes effective in fiscal 2018 and early adoption in fiscal 2017 is permitted.

We anticipate this standard will have a material impact on our consolidated financial statements by accelerating the timing of revenue recognition for revenues related to royalties, and potentially certain contingent milestone based payments. Our practice has been to book royalties one quarter after our partners report sales of the underlying product. Now, under ASC 606, Ligand will estimate and book royalties in the same quarter that our partners report the sale of the underlying product. As a result, we will book royalties one quarter earlier compared to our past practice. We will rely on our partners’ earning releases and other information from our partners to determine the sales of our partners’ products and to estimate the related royalty revenues. If our partners report incorrect sales, or if our partners delay reporting of their earnings release, our royalty estimates may need to be revised and/or our financial reporting may be delayed.

Any difficulties in implementing this guidance could cause us to fail to meet our financial reporting obligations, which could result in regulatory discipline and harm investors’ confidence in us. Finally, if we were to change our critical accounting estimates, including those related to the recognition of license revenue and other revenue sources, our operating results could be significantly affected.

Our ability to use our net operating loss carryforwards and certain other tax attributes to offset future taxable income may be subject to certain limitations.
As of December 31, 2016 we had U.S. federal and state net operating loss carryforwards (NOLs) of approximately $446.3 million and $140.5 million, respectively, which expire through 2036, if not utilized. As of December 31, 2016, we had federal and California research and development tax credit carryforwards of approximately $21.9 million and $19.4 million, respectively. The federal research and development tax credit carryforwards expire in various years through 2036, if not utilized. The California research and development credit will carry forward indefinitely. Under Sections 382 and 383 of Internal Revenue Code of 1986, as amended (Code) if a corporation undergoes an “ownership change,” the corporation’s ability to use

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its pre-change NOLs and other pre-change tax attributes, such as research tax credits, to offset its future post-change income and taxes may be limited. In general, an “ownership change” occurs if there is a cumulative change in our ownership by “5% shareholders” that exceeds 50 percentage points over a rolling three-year period. Similar rules may apply under state tax laws. We believe we have experienced certain ownership changes in the past and have reduced our deferred tax assets related to NOLs and research and development tax credit carryforwards accordingly. In the event that it is determined that we have in the past experienced additional ownership changes, or if we experience one or more ownership changes as a result future transactions in our stock, then we may be further limited in our ability to use our NOLs and other tax assets to reduce taxes owed on the net taxable income that we earn in the event that we attain profitability. Any such limitations on the ability to use our NOLs and other tax assets could adversely impact our business, financial condition and operating results.

We rely on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cyber security incidents, could harm our ability to operate our business effectively.

Our business is increasingly dependent on critical, complex and interdependent information technology systems, including internet-based systems, to support business processes as well as internal and external communications. Despite the implementation of security measures, our internal computer systems and those of our partners are vulnerable to damage from cyber-attacks, computer viruses, security breaches, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. System failures, accidents or security breaches could cause interruptions in our operations, could lead to the loss of trade secrets or other intellectual property, could lead to the public exposure of personal information of our employees and others, and could result in a material disruption of our clinical and commercialization activities and business operations, in addition to possibly requiring substantial expenditures to remedy. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and our business and financial condition could be harmed.

The occurrence of a catastrophic disaster could damage our facilities beyond insurance limits or we could lose key data which could cause us to curtail or cease operations.

We are vulnerable to damage and/or loss of vital data from natural disasters, such as earthquakes, tornadoes, power loss, fire, floods and similar events, as well as from accidental loss or destruction. If any disaster were to occur, our ability to operate our business could be seriously impaired. We have property, liability, and business interruption insurance which may not be adequate to cover our losses resulting from disasters or other similar significant business interruptions, and we do not plan to purchase additional insurance to cover such losses due to the cost of obtaining such coverage. Any significant losses that are not recoverable under our insurance policies could seriously impair our business, financial condition and prospects.

We sold the 2019 Convertible Senior Notes, which may impact our financial results, result in the dilution of existing stockholders, and restrict our ability to take advantage of future opportunities.
    
In August of 2014, we sold $245.0 million aggregate principal amount of 0.75% Convertible Senior Notes due 2019, or the 2019 Convertible Senior Notes. We will be required to pay interest on the 2019 Convertible Senior Notes until they come due or are converted, and the payment of that interest will reduce our net income. The sale of the 2019 Convertible Senior Notes may also affect our earnings per share figures, as accounting procedures require that we include in our calculation of earnings per share the number of shares of our common stock into which the 2019 Convertible Senior Notes are convertible. The 2019 Convertible Senior Notes may be converted, under the conditions and at the premium specified in the 2019 Convertible Senior Notes, into cash and shares of our common stock, if any (subject to our right to pay cash in lieu of all or a portion of such shares). If shares of our common stock are issued to the holders of the 2019 Convertible Senior Notes upon conversion, there will be dilution to our shareholders equity. Upon the occurrence of certain circumstances, holders of the 2019 Convertible Senior Notes may require us to purchase all or a portion of their notes for cash, which may require the use of a substantial amount of cash. If such cash is not available, we may be required to sell other assets or enter into alternate financing arrangements at terms that may or may not be desirable. The existence of the 2019 Convertible Senior Notes and the obligations that we incurred by issuing them may restrict our ability to take advantage of certain future opportunities, such as engaging in future debt or equity financing activities.

Impairment charges pertaining to goodwill, identifiable intangible assets or other long-lived assets from our mergers and acquisitions could have an adverse impact on our results of operations and the market value of our common stock.

The total purchase price pertaining to our acquisitions in recent years of CyDex, Metabasis, Pharmacopeia, Neurogen and OMT have been allocated to net tangible assets, identifiable intangible assets, in-process research and development and goodwill. To the extent the value of goodwill or identifiable intangible assets or other long-lived assets become impaired, we

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will be required to incur material charges relating to the impairment. Any impairment charges could have a material adverse impact on our results of operations and the market value of our common stock.

Our charter documents and concentration of ownership may hinder or prevent change of control transactions.

Provisions contained in our certificate of incorporation and bylaws may discourage transactions involving an actual or potential change in our ownership. In addition, our Board of Directors may issue shares of common or preferred stock without any further action by the stockholders. Our directors and certain of our institutional investors collectively beneficially own a significant portion of our outstanding common stock. Such provisions and issuances may have the effect of delaying or preventing a change in our ownership. If changes in our ownership are discouraged, delayed or prevented, it would be more difficult for our current Board of Directors to be removed and replaced, even if you or our other stockholders believe that such actions are in the best interests of us and our stockholders.

We may be subject to prosecution for violation of federal law due to our agreement with Vireo Health, which is developing drugs using cannabis.

In November 2015, we entered into a license agreement and supply agreement with Vireo Health granting Vireo Health an exclusive right in certain states within the United States and certain global territories to use Captisol in Vireo’s development and commercialization of pharmaceutical-grade cannabinoid-based products. However, state laws legalizing medical cannabis use are in conflict with the Federal Controlled Substances Act, which classifies cannabis as a schedule-I controlled substance and makes cannabis use and possession illegal on a national level. The United States Supreme Court has ruled that it is the Federal government that has the right to regulate and criminalize cannabis, even for medical purposes, and thus Federal law criminalizing the use of cannabis preempts state laws that legalize its use. While the Obama administration effectively stated that it is not an efficient use of resources to direct Federal law enforcement agencies to prosecute those lawfully abiding by state-designated laws allowing the use and distribution of medical and recreational cannabis, the Trump administration has indicated that it will reconsider such policy and practice, especially with respect to recreational cannabis. Further, even if the Trump administration affirms the same approach with respect to medical or recreational cannabis initially, there is no guarantee that such policy and practice will not change regarding the low-priority enforcement of Federal laws in states where cannabis has been legalized. Any such change in the Federal government’s enforcement of Federal laws could result in Ligand, as the supplier of Captisol, to be charged with violations of Federal laws which may result in significant legal expenses and substantial penalties and fines.

Our stock price has been volatile and could experience a sudden decline in value.

The market prices for securities of biotechnology and pharmaceutical companies have historically been highly volatile, and the market has recently experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. Continued volatility in the overall capital markets could reduce the market price of our common stock in spite of our operating performance. Further, high stock price volatility could result in higher stock-based compensation expense.

Our common stock has experienced significant price and volume fluctuations and may continue to experience volatility in the future. Many factors may have a significant impact on the market price of our common stock, including, but not limited to, the following factors: results of or delays in our preclinical studies and clinical trials; the success of our collaboration agreements; publicity regarding actual or potential medical results relating to products under development by us or others; announcements of technological innovations or new commercial products by us or others; developments in patent or other proprietary rights by us or others; comments or opinions by securities analysts or major stockholders; future sales of our common stock by existing stockholders; regulatory developments or changes in regulatory guidance; litigation or threats of litigation; economic and other external factors or other disaster or crises; the departure of any of our officers, directors or key employees; period-to-period fluctuations in financial results; and price and volume fluctuations in the overall stock market.

Our results of operations and liquidity needs could be materially negatively affected by market fluctuations and economic downturn.

Our results of operations could be materially negatively affected by economic conditions generally, both in the United States and elsewhere around the world. Continuing concerns over inflation, energy costs, geopolitical issues, the availability and cost of credit, and the U.S. financial markets have contributed to increased volatility and diminished expectations for the economy and the markets going forward. Domestic and international equity markets periodically experience heightened volatility and turmoil. These events may have an adverse effect on us. In the event of a market downturn, our results of operations could be adversely affected by those factors in many ways, including making it more difficult for us to raise funds if

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necessary, and our stock price may further decline. We cannot provide assurance that our investments are not subject to adverse changes in market value. If our investments experience adverse changes in market value, we may have less capital to fund our operations.

Item 1B.
Unresolved Staff Comments
None.
 
Item 2.
Properties
We currently lease premises consisting of approximately 5,000 square feet of office space in San Diego which serves as our corporate headquarters. The lease expires in May 2023.
We lease approximately 1,500 square feet of laboratory space located at the Bioscience and Technology Business Center in Lawrence, Kansas, leased through December 2017.

Item 3.
Legal Proceedings

From time to time we are subject to various lawsuits and claims with respect to matters arising out of the normal course of our business.  Due to the uncertainty of the ultimate outcome of these matters, the impact on future financial results is not subject to reasonable estimates.

Paragraph IV Certification by Par Pharmaceuticals

On January 7, 2016, the Company received a paragraph IV certification from Par Sterile Products, LLC, a subsidiary of Par Pharmaceuticals, Inc., or Par, advising us that it had filed an ANDA with the FDA seeking approval to market a generic version of Merck’s NOXAFIL-IV product. On February 19, 2016, Merck filed an action against Par in the United States District Court for the District of New Jersey, asserting that Par's manufacture, use or sale of the product for which the ANDA was submitted would infringe Merck's U.S. Patent No. 9,023,790. On October 31, 2016, the parties to the lawsuit entered into a consent judgment dismissing all claims, counterclaims, affirmative defenses and demands. The parties have reported to the court that they entered into a confidential settlement agreement, and that they submitted the agreement to the Federal Trade Commission and the United States Department of Justice pursuant to Section 112(a) of the Medicare Prescription Drug, Improvement and Modernization Act of 2003. 

Class Action Lawsuit

In November 2016, a putative shareholder class action lawsuit was filed in the United States District Court for the Southern District of California against the Company, its chief executive officer and chief financial officer. The complaint alleges violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and Rule 10b-5 promulgated thereunder, and seeks unspecified compensatory damages and other relief on behalf of a purported class of purchasers of the Company’s securities between November 9, 2015 and November 14, 2016, inclusive. The complaint’s allegations relate generally to the Company’s November 2016 restatement of certain prior period financial statements.  In January 2017, a purported Company shareholder filed a motion for appointment of lead counsel and lead plaintiff. The motion is scheduled to be heard by the court in March 2017. No trial date has been set. The Company believes that the lawsuit is without merit and intends to vigorously defend against the lawsuit.
Securities Litigation

In 2012, a federal securities class action and shareholder derivative lawsuit was filed in Pennsylvania alleging that the Company and its chief executive officer assisted various breaches of fiduciary duties based on our purchase of a licensing interest in a development-stage pharmaceutical program from the Genaera Liquidating Trust in 2010 and our subsequent sale of half of our interest in the transaction to Biotechnology Value Fund, Inc.  The district court granted our motion to dismiss an amended complaint on November 11, 2015 and the plaintiff has appealed that ruling to the U.S. Third Circuit Court of Appeals.  The Company intends to continue to vigorously defend against the claims against the Company and its chief executive officer.  The outcome of the matter is not presently determinable.


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Item 4.
Mine Safety Disclosures
Not applicable.
PART II
 
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities
Market Information
Our common stock is traded on the NASDAQ Global Market under the symbol “LGND.”
The following table sets forth the high and low intraday sales prices for our common stock on the NASDAQ Global Market for the periods indicated:
 
 
Price Range
 
Low
 
High
Year Ended December 31, 2016:
 
 
 
1st Quarter
$
82.06

 
$
108.79

2nd Quarter
95.05

 
131.84

3rd Quarter
97.22

 
139.79

4th Quarter
87.50

 
110.83

Year Ended December 31, 2015:
 
 
 
1st Quarter
$
51.54

 
$
77.11

2nd Quarter
75.67

 
100.90

3rd Quarter
82.10

 
111.25

4th Quarter
84.46

 
111.85

As of February 15, 2017, the closing price of our common stock on the NASDAQ Global Market was $104.28
Holders
As of February 15, 2017, there were approximately 576 holders of record of the common stock.

Purchases of Equity Securities By the Issuer and Affiliated Purchasers

The following table presents information regarding repurchases by us of our common stock during the three months ended December 31, 2016 under the stock repurchase program approved by our board of directors in September 2015, under which we may acquire up to $200 million of our common stock in open market and negotiated purchases for a period of up to three years.

ISSUER PURCHASES OF EQUITY SECURITIES

 
  
Total Number of
Shares Purchased
 
Average Price Paid
Per Share
 
Total Number of
Shares Purchased as
Part of Publicly
Announced Plans or
Programs
 
Maximum Dollar Value of
Shares that May Yet Be
Purchased Under the
Program (in thousands)
October 1 - October 31, 2016
 
15,000

 
$
93.91

 
15,000

 
$
196,548

November 1 - November 30, 2016
 
10,000

 
$
93.83

 
10,000

 
$
195,610

December 1 - December 31, 2016
 

 
$

 

 
$
195,610

Total
  
25,000

 
$
93.88

 
25,000

 
$
195,610

 
Performance Graph

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The graph below shows the five-year cumulative total stockholder return assuming the investment of $100 and is based on the returns of the component companies weighted monthly according to their market capitalizations. The graph compares total stockholder returns of our common stock, of all companies traded on the NASDAQ Stock market, as represented by the NASDAQ Composite® Index, and of the NASDAQ Biotechnology Stock Index, as prepared by The NASDAQ Stock Market Inc. The NASDAQ Biotechnology Stock Index tracks approximately 181 domestic biotechnology stocks.
The stockholder return shown on the graph below is not necessarily indicative of future performance and we will not make or endorse any predictions as to future stockholder returns.
stockperformancegraphv3.jpg
 
 
12/31/2012
 
12/31/2013
 
12/31/2014
 
12/31/2015
 
12/31/2016
Ligand
 
75
%
 
154
%
 
1
%
 
104
%
 
(6
)%
NASDAQ Market (U.S. Companies) Index
 
17
%
 
40
%
 
15
%
 
7
%
 
9
 %
NASDAQ Biotechnology Stocks
 
33
%
 
66
%
 
34
%
 
12
%
 
(21
)%



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Table of Contents

Item 6.
Selected Consolidated Financial Data
The following selected historical consolidated financial and other data are qualified by reference to, and should be read in conjunction with, our consolidated financial statements and the related notes thereto appearing elsewhere herein and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Our selected statement of operations data set forth below for each of the years ended December 31, 2016, 2015, 2014, 2013, and 2012 and the balance sheet data as of December 31, 2016, 2015, 2014, 2013 and 2012 are derived from our consolidated financial statements.
 
 
Year Ended December 31,
 
2016
 
2015
 
2014
 
2013
 
2012
Consolidated Statements of Operations Data:
(in thousands)
Royalties
$
59,423

 
$
38,194

 
$
29,994

 
$
23,584

 
$
14,073

Material sales
22,502

 
27,662

 
28,488

 
19,072

 
9,432

License fees, milestones, and other revenues
27,048

 
6,058

 
6,056

 
6,317

 
7,883

     Total revenues
108,973

 
71,914

 
64,538

 
48,973

 
31,388

Cost of sales
5,571

 
5,807

 
9,136

 
3,357

 
1,226

Intangible Amortization
10,643

 
2,375

 
2,375

 
2,375

 
2,375

Research and development expenses
21,221

 
11,005

 
9,747

 
9,274

 
10,790

General and administrative expenses
26,621

 
24,378

 
22,570

 
17,984

 
15,782

Lease exit and termination costs
1,032

 
1,020

 
1,084

 
560

 
1,022

Write-off of acquired IPR&D

 

 

 
480

 

     Total operating costs and expenses
65,088

 
44,585

 
44,912

 
34,030

 
31,195

Income (loss) from operations
43,885

 
27,329

 
19,626

 
14,943

 
193

Income (loss) from continuing operations including noncontrolling interests
(2,367
)
 
227,444

 
10,892

 
8,832

 
(2,674
)
Loss attributable to noncontrolling interests

 
(2,380
)
 
(1,132
)
 

 

Income (loss) from continuing operations
(2,367
)
 
229,824

 
12,024

 
8,832

 
(2,674
)
Discontinued operations (1)
731

 

 

 
2,588

 
2,147

Net income (loss)
(1,636
)
 
229,824

 
12,024

 
11,420

 
(527
)
Basic per share amounts:
 
 
 
 
 
 
 
 
 
Income (loss) from continuing operations
$
(0.11
)

$
11.61

 
$
0.59

 
$
0.43

 
$
(0.14
)
Discontinued operations (1)
0.04

 

 

 
0.13

 
0.11

Net income (loss)
$
(0.08
)
 
$
11.61

 
$
0.59

 
$
0.56

 
$
(0.03
)
Weighted average number of common shares-basic
20,831

 
19,790

 
20,419

 
20,312

 
19,853

Diluted per share amounts:
 
 
 
 
 
 
 
 
 
Income (loss) from continuing operations
$
(0.11
)

$
10.83

 
$
0.56

 
$
0.43

 
$
(0.14
)
Discontinued operations (1)
0.04



 

 
0.12

 
0.11

Net income (loss)
$
(0.08
)
 
$
10.83

 
$
0.56

 
$
0.55

 
$
(0.03
)
Weighted average number of common shares-diluted
20,831

 
21,228

 
21,433

 
20,745

 
19,853

(1) We sold our Oncology product line (“Oncology”) on October 25, 2006.


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December 31,
 
2016
 
2015
 
2014
 
2013
 
2012
 
(in thousands)
Consolidated Balance Sheet Data:
 
 
 
 
 
 
 
 
 
Cash, cash equivalents, short-term investments, restricted cash and investments
$
149,393

 
$
229,947

 
$
168,597

 
$
17,320

 
$
15,148

Working capital (deficit)
(64,076
)
 
(8,109
)
 
162,379

 
(4,058
)
 
(11,616
)
Total assets
601,585

 
503,061

 
258,029

 
104,713

 
104,260

Long-term obligations (excludes long-term portions of deferred revenue, net and deferred gain)
3,603

 
3,330

 
208,757

 
24,076

 
39,967

Accumulated deficit
(431,127
)
 
(429,491
)
 
(659,315
)
 
(671,339
)
 
(682,759
)
Total stockholders’ equity
341,290

 
237,282

 
26,318

 
49,613

 
26,485


Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations

Results of Operations

Revenue
(Dollars in thousands)
2016
 
2015
 
Change
 
% Change
 
2014
 
Change
 
% Change
Royalty Revenue
$
59,423

 
$
38,194

 
$
21,229

 
56
 %
 
$
29,994

 
$
8,200

 
27
 %
Material Sales
22,502

 
27,662

 
(5,160
)
 
(19
)%
 
28,488

 
(826
)
 
(3
)%
License fees, milestones and other revenue
27,048

 
6,058

 
20,990

 
346
 %
 
6,056

 
2

 
 %
Total revenue
$
108,973

 
$
71,914

 
$
37,059

 
52
 %
 
$
64,538

 
$
7,376

 
11
 %

Total revenue for 2016 increased $37.1 million or 52% compared with 2015 and for 2015 it increased $7.4 million or 11% compared with 2014. Royalty revenue increased year over year in 2016 and 2015 primarily due to an increase in Promacta and Kyprolis royalties. Material sales decreased year over year in 2016 and 2015 due to timing of customer purchases of Captisol for use in clinical trials and in commercialized products. The increase in license fee, milestones and other revenues in 2016 compared to 2015 is primarily due to OMT license fees and a milestone payment received from Spectrum as a result of the FDA approval of Evomela.

The following table represents royalty revenue by program (in thousands):
 
Year ended December 31,
 
2016
 
2015
 
2014
Promacta / Revolade
$
43,043

 
$
29,295

 
$
23,300

Kyprolis
12,145

 
7,317

 
4,558

Third Largest Royalty
1,357

 
390

 
1,244

Other Royalties
2,878

 
1,192

 
892

     Total
$
59,423

 
$
38,194

 
$
29,994


The following table represents material sales by clinical and commercial use (in thousands):
 
Year ended December 31,
 
2016
 
2015
 
2014
Clinical material sales
$
9,325

 
$
10,049

 
$
13,798

Commercial material sales
13,177

 
17,613

 
14,690

     Total
$
22,502

 
$
27,662

 
$
28,488


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Operating Costs and Expenses
(Dollars in thousands)
2016
 
2015
 
Change
 
% Change
 
2014
 
Change
 
% Change
Cost of sales
$
5,571

 
$
5,807

 
$
(236
)
 
(4
)%
 
$
9,136

 
$
(3,329
)
 
(36
)%
Amortization of intangibles
10,643

 
2,375

 
8,268

 
348
 %
 
2,375

 

 
 %
Research and development
21,221

 
11,005

 
10,216

 
93
 %
 
9,747

 
1,258

 
13
 %
General and administrative
26,621

 
24,378

 
2,243

 
9
 %
 
22,570

 
1,808

 
8
 %
Lease exit and termination costs
1,032

 
1,020

 
12

 
1
 %
 
1,084

 
(64
)
 
(6
)%
Total operating costs and expenses
$
65,088

 
$
44,585

 
$
20,503

 
46
 %
 
$
44,912

 
$
(327
)
 
(1
)%

Total operating costs and expenses for 2016 increased $20.5 million or 46% compared with 2015. Cost of sales decreased year over year in 2016 and 2015 primarily due to lower material sales as a result of timing of customer purchases. Amortization of intangibles increased in 2016 compared with 2015 due to the acquisition of OMT and the corresponding amortization of intangible assets. Research and development expenses and general and administrative expenses increased year over year in 2016 and 2015 due primarily to expenses associated with OMT which we acquired in January 2016 and increases in stock-based compensation expense, business development activities, headcount related expenses and timing of internal development costs.

We are developing several proprietary products. Our programs represent a range of future licensing opportunities to expand our partnered asset portfolio. Our development focus for the year ended December 31, 2016, 2015, and 2014 has been LGD-6972, our novel glucagon receptor antagonist program. We completed a Phase 1b trial in 2015 and initiated a Phase 2 trial in 2016.

We do not provide forward-looking estimates of costs and time to complete our ongoing research and development projects as such estimates would involve a high degree of uncertainty. Uncertainties include our inability to predict the outcome of research and clinical studies, regulatory requirements placed upon us by regulatory authorities such as the FDA and EMA, our inability to predict the decisions of our partners, our ability to fund research and development programs, competition from other entities of which we may become aware in future periods, predictions of market potential for products that may be derived from our work, and our ability to recruit and retain personnel or third-party contractors with the necessary knowledge and skills to perform certain research. Refer to “Item 1A. Risk Factors” for additional discussion of the uncertainties surrounding our research and development initiatives.

Other (expense) income
(Dollars in thousands)
2016
 
2015
 
Change
 
% Change
 
2014
 
Change
 
% Change
Interest expense, net
$
(12,178
)
 
$
(11,802
)
 
$
(376
)
 
3
 %
 
$
(4,860
)
 
$
(6,942
)
 
143
 %
Increase in contingent liabilities
(3,334
)
 
(5,013
)
 
1,679

 
(33
)%
 
(5,135
)
 
122

 
(2
)%
Gain on deconsolidation of Viking

 
28,190

 
(28,190
)
 
(100
)%
 

 
28,190

 
 %
Loss from Viking
(23,132
)
 
(5,143
)
 
(17,989
)
 
350
 %
 

 
(5,143
)
 
 %
Other income, net
2,719

 
1,768

 
951

 
54
 %
 
1,671

 
97

 
6
 %
Total other (expense) income
$
(35,925
)
 
$
8,000

 
$
(43,925
)
 
(549
)%
 
$
(8,324
)
 
$
16,324

 
(196
)%

The year over year increase in interest expense in 2016 and 2015 is due to interest expense related to the 2019 Convertible Senior Notes partially offset by interest income. The year over year increase in contingent liabilities in 2016 and 2015 is due to an increase in the fair value of CyDex and Metabasis related contingent liabilities. We recorded a gain on deconsolidation of Viking in 2015, primarily related to the equity milestone received from Viking upon the close of the Viking

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IPO. We recorded a loss from Viking in 2016 for our proportionate share of Viking’s losses based on our ownership of Viking common stock and $10.7 million for loss on dilution resulting from Viking's financing. The 2016 year over year increase in loss from Viking is primarily due to an impairment charge of $7.4 million recorded in the fourth quarter of 2016, an increase in Viking's research and development activities as well as a full year of absorbed losses in 2016 versus 2015 which was a partial year as the Company began accounting for Viking under the equity method in May of 2015. The increase in other income in 2016 compared to 2015 is primarily due to the gain on the sale of short-term investments.

Income tax benefit (expense)
(Dollars in thousands)
2016
 
2015
 
Change
 
% Change
 
2014
 
Change
 
% Change
Income before income tax (benefit) expense
$
7,960

 
$
35,329

 
$
(27,369
)
 
(77
)%
 
$
11,302

 
$
24,027

 
213
 %
Income tax benefit (expense)
(10,327
)
 
192,115

 
(202,442
)
 
(105
)%
 
(410
)
 
192,525

 
(46,957
)%
Income from operations
$
(2,367
)
 
$
227,444

 
$
(229,811
)
 
(101
)%
 
$
10,892

 
$
216,552

 
1,988
 %
Effective Tax Rate
130
%
 
(544
)%
 
 
 
 
 
4
%
 
 
 
 


Our effective tax rate for 2016, 2015 and 2014 was 129.7% , (543.8)% , and 3.6% , respectively. Our tax rate is affected by recurring items, such as the U.S. federal and state statutory tax rates and the relative amounts of income we earn in those jurisdictions, which we expect to be fairly consistent in the near term. It is also affected by discrete items that may occur in any given year, but are not consistent from year to year. In addition to state income taxes, the following had the most significant impact on the difference between our statutory U.S. income tax rate (35% in 2016 and 2015 and 34% in 2014) and our effective tax rate:

2016

$6.3 million (79%) increase in valuation allowance primarily relating to Viking deferred tax asset
$1.4 million (18%) increase in uncertain tax positions
$1.2 million (15%) increase from non cash contingent liability charges that are nondeductible for tax purposes
$1.5 million (19%) reduction from R&D credits

2015

$231.4 million (655%) reduction from the valuation allowance release against a significant portion of our deferred tax assets. The tax benefit is primarily comprised of U.S. federal and state net operating loss carryforwards, R&D tax credits, and other temporary differences
$5.8 million (16%) reduction from rate changes due to changes in state law
$2.1 million (6%) reduction from adjustments relating to the discontinuation of the Avinza product line
$27.2 million (77%) increase in uncertain tax positions
$3.3 million (9%) increase in deferred tax assets from completion of 382 analysis
$1.7 million (5%) increase from non cash CVR and contingent liability charges that are nondeductible for tax purposes

2014

$7.2 million (64%) reduction due to release of valuation allowance against a portion of our deferred tax assets.
$1.7 million (15%) increase from non cash contingent liability charges that are nondeductible for tax purposes
$0.7 million (6%) increase from state taxes net of federal benefit
$0.6 million (4%) increase from nondeductible stock based and executive compensation



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Discontinued operations, net

In 2006, we entered into a purchase agreement with Eisai pursuant to which Eisai agreed to acquire our Oncology product line which included four marketed oncology drugs: ONTAK, Targretin capsules, Targretin gel and Panretin gel. Certain liabilities were recorded associated with the disposal of the product line. During the year ended December 31, 2016 we recognized a $1.1 million gain due to subsequent changes in certain estimates and liabilities previously recorded. We recorded a provision for income taxes related to the gain of $0.4 million.
    
Net loss attributable to noncontrolling interests

We recorded $2.4 million as a net loss attributable to noncontrolling interests for the year ended December 31, 2015 compared with $1.1 million for the year ended December 31, 2014. The net loss attributable to noncontrolling interests was recorded as a result of our determination that prior to Viking's IPO we held a variable interest in Viking. We recorded 100% of the losses incurred from May 21, 2014 through deconsolidation of Viking, as net loss attributable to noncontrolling interest due to the fact that we were considered the primary beneficiary with no equity interest in the variable interest entity.

Liquidity and Capital Resources
We have financed our operations through offerings of our equity securities, borrowings from long-term debt, issuance of convertible notes, product sales and the subsequent sales of our commercial assets, royalties, license fees, milestones and other revenues, capital and operating lease transactions.

We had net loss of $1.6 million for the year ended December 31, 2016. At December 31, 2016, our accumulated deficit was $431.1 million and we had a working capital deficit of $64.1 million. We believe that our currently available funds, cash generated from operations as well as existing sources of and access to financing will be sufficient to fund our anticipated operating, capital requirements and debt service requirement. We expect to build cash in the future as we continue to generate significant cash flow from royalty, license and milestone revenue and Captisol material sales primarily driven by continued increases in Promacta and Kyprolis sales, recent product approvals and regulatory developments, as well as revenue from anticipated new licenses and milestones. In addition, we anticipate that our liquidity needs can be met through other sources, including sales of marketable securities, borrowings through commercial paper and/or syndicated credit facilities and access to other domestic and foreign debt markets and equity markets.

Investments

We invest our excess cash principally in U.S. government debt securities, investment-grade corporate debt securities and certificates of deposit. We have established guidelines relative to diversification and maturities of our investments in order to provide both safety and liquidity. These guidelines are periodically reviewed and modified to take advantage of trends in yields and interest rates. Additionally, we own certain securities which are classified as short-term investments that we received as a result of a milestone and an upfront license payment as well as 6.3 million shares in Viking.     

Borrowings and Other Liabilities

2019 Convertible Senior Notes
    
We have convertible debt outstanding as of December 31, 2016 related to our 2019 Convertible Senior Notes. In August 2014, we issued $245.0 million aggregate principal amount of convertible senior unsecured notes. The Notes are convertible into common stock upon satisfaction of certain conditions. Interest of 0.75% per year is payable semi-annually on August 15th and February 15th through the maturity of the notes in August 2019.

Upon the occurrence of certain circumstances, holders of the 2019 Convertible Senior Notes may redeem all or a portion of their notes, which may require the use of a substantial amount of cash. At December 31, 2016, we had a working capital deficit of $64.1 million, which includes the 2019 Convertible Senior notes that are currently redeemable as of December 31, 2016 but excludes another $30.0 million that is classified as mezzanine equity.  As noted in Note 6, the debt may change from current to non-current period over period, primarily as a result of changes in the Company’s stock price. Management believes that it is remote that holders of the notes would choose to convert their notes early because the fair value of the security that a noteholder can currently realize in an active market is greater than the conversion value the noteholder would realize upon early conversion. In the unlikely event that all the debt was converted, we have 3 business days following a

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50 trading day observation period from the convert date to pay the principal in cash. We have positive operating income and positive cash flow from operations for the three years ended December 31, 2016 and, accordingly, while there can be no assurance, we believe we have the ability to raise additional capital through our active S-3, by liquidating assets, or via alternative financing arrangements such as convertible or high yield debt.

Repurchases of Common Stock

During the year ended December 31, 2016, we repurchased 40,500 common shares at a weighted average price of $96.90 per share, pursuant to the repurchase plan, or approximately $3.9 million of common shares.

During the year ended December 31, 2015, we repurchased 6,120 common shares at a weighted average price of $79.92 per share, pursuant to the repurchase plan, or approximately 0.5 million of common shares.

Contingent Liabilities

CyDex

In connection with the acquisition of CyDex in January 2011, we issued a series of CVRs and also assumed certain contingent liabilities. We may be required to make additional payments upon achievement of certain clinical and regulatory milestones to the CyDex shareholders and former license holders. We pay CyDex shareholders, through 2016, 20% of all CyDex-related revenue, but only to the extent that, and beginning only when, CyDex-related revenue for the year exceeds $15.0 million; plus an additional 10% of all CyDex-related revenue recognized during such year, but only to the extent, and beginning only when aggregate CyDex-related revenue for such year exceeds $35.0 million. See footnote 7, Balance Sheet Account Details.
 

Metabasis

In connection with the acquisition of Metabasis in January 2010, we entered into four CVR agreements with Metabasis shareholders. The CVRs entitle the holders to cash payments as frequently as every six months as proceeds are received by us upon the sale or licensing of any of the Metabasis drug development programs and upon the achievement of specified milestones. See footnote 7, Balance Sheet Account Details.
Leases and Off-Balance Sheet Arrangements

We lease our office facilities under operating lease arrangements with varying terms through April 2023. The agreements provide for increases in annual rents based on changes in the Consumer Price Index or fixed percentage increases of 3.0%. We had no off-balance sheet arrangements at December 31, 2016, 2015 and 2014.
Contractual Obligations
As of December 31, 2016, future minimum payments due under our contractual obligations are as follows (in thousands):
 
 
Payments Due by Period
 
Total
 
Less than 1 year
 
1-2 years
 
3-4 years
 
Thereafter
Purchase obligations (1)
$
61

 
$
36

 
$
25

 
$

 
$

Contingent liabilities (2)
$
4,977

 
$
4,977

 
$

 
$