Ligand Pharmaceuticals, Inc. (LGND) News http://investor.ligand.com/rss The latest news released by Ligand Pharmaceuticals, Inc. (LGND) en-us Equisolve Investor Relations Suite http://content.stockpr.com/ligand/files/logo-ligand.png Ligand Pharmaceuticals, Inc. (LGND) News http://investor.ligand.com/rss 88 31 Ligand to Participate in Two Upcoming Investor Conferences http://investor.ligand.com/news/detail/324/ligand-to-participate-in-two-upcoming-investor-conferences Mon, 22 May 2017 09:00:00 -0400 http://investor.ligand.com/news/detail/324/ligand-to-participate-in-two-upcoming-investor-conferences

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that company executives are scheduled to participate in the following upcoming investor conferences:

  • 14th Annual Craig-Hallum Institutional Investor Conference in Minneapolis. Conference takes place on Wednesday, May 31, 2017 with one-on-one meetings only. John Higgins, CEO; Matt Foehr, President and COO; and Matt Korenberg, CFO, will attend for Ligand.
  • Jefferies Healthcare Conference in New York City. Presentation takes place on Thursday, June 8, 2017 at 4:00 p.m. Eastern time (1:00 p.m. Pacific time). John Higgins, CEO; Matt Foehr, President and COO; and Matt Korenberg, CFO, will attend for Ligand.

A live webcast of the presentation will be available on Ligand’s website at www.ligand.com. A replay of the presentation will be archived on the website for 30 days.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono- and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Contacts:
Ligand Pharmaceuticals Incorporated
Todd Pettingill
investors@ligand.com
(858) 550-7500
@Ligand_LGND
or
LHA
Bruce Voss
bvoss@lhai.com
(310) 691-7100

Source: Ligand Pharmaceuticals Incorporated

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Ligand Reports First Quarter 2017 Financial Results http://investor.ligand.com/news/detail/323/ligand-reports-first-quarter-2017-financial-results Tue, 09 May 2017 16:01:00 -0400 http://investor.ligand.com/news/detail/323/ligand-reports-first-quarter-2017-financial-results

Conference Call Begins at 4:30 p.m. Eastern Time Today

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today reported financial results for the three months ended March 31, 2017, and provided an operating forecast and program updates. Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time.

“We are pleased to be reporting a substantial increase in first quarter royalty revenue led by Promacta®, Kyprolis® and EVOMELA®, as well as strong cash flow from operations. In addition to achieving solid sales growth, our partners made important clinical, regulatory and commercial progress on a global basis,” said John Higgins, Chief Executive Officer. “During the first quarter we completed enrollment in a Phase 2 clinical trial with our novel, small-molecule GRA program for the treatment of type 2 diabetes mellitus, and we look forward to reporting topline results this September. We also added to our Shots-on-Goal business model with new licensing agreements including those for OmniAb® and Captisol®.”

First Quarter 2017 Financial Results

Total revenues for the first quarter of 2017 were $29.3 million, compared with $29.6 million for the same period in 2016. Royalties were $24.2 million, compared with $14.4 million for the same period in 2016, an increase of 68%, primarily due to higher royalties from Promacta and Kyprolis and new royalties from EVOMELA this period, compared to a year ago. Material sales were $1.1 million, compared with $5.3 million for the same period in 2016 due to timing of Captisol® purchases for use in clinical trials and commercial products. License fees, milestones and other revenues were $3.9 million, compared with $9.9 million for the same period in 2016, which included receipt of a $6.0 million approval milestone for EVOMELA.

Cost of goods sold was $0.3 million for the first quarter of 2017, compared with $1.0 million for the same period in 2016 due to the timing and mix of Captisol sales. Amortization of intangibles was $2.7 million, compared with $2.5 million for the same period in 2016. Research and development expense was $8.7 million, compared with $4.0 million for the same period of 2016 due to enrollment costs of our Phase 2 GRA trial and non-cash stock-based compensation expense. General and administrative expense was $7.3 million, compared with $7.1 million for the same period in 2016.

Net income for the first quarter of 2017 was $5.1 million, or $0.22 per diluted share, compared with $6.6 million, or $0.30 per diluted share for the same period in 2016. Adjusted net income for the first quarter of 2017 was $12.6 million, or $0.57 per diluted share, compared with $13.6 million, or $0.63 per diluted share for the same period in 2016.

As of March 31, 2017, Ligand had cash, cash equivalents and short-term investments of $159.4 million. Cash generated from operations was $24.2 million for the 2017 first quarter.

2017 Financial Forecast

The Company expects 2017 revenues to consist of three components: royalties, material sales and contract (license and milestone) revenue. Ligand affirms previous guidance of 2017 core revenue to include royalties of approximately $87 million, material sales of approximately $23 million and contract payments of at least $20 million. During 2017, Ligand estimates it could potentially receive up to an additional $24 million of contract payments; however, external events are out of Ligand’s control so the Company will provide more information about the timing and probability for additional contract revenue, if any, expected to be booked in 2017 as the year progresses. Ligand notes that with core revenue of $130 million, adjusted earnings per diluted share would be approximately $2.70. This amount is expected to be higher in the event additional contract revenue is received in 2017.

First Quarter 2017 and Recent Business Highlights

Portfolio Program Progress

Promacta®/Revolade®

  • Novartis reported first quarter 2017 net sales of Promacta/Revolade (eltrombopag) of $175 million, a $44 million or 34% increase over the same period in 2016.
  • Novartis reported Revolade (eltrombopag) was approved in Canada for the treatment of pediatric (≥1 years to <18 years) chronic immune thrombocytopenia purpura to increase platelet counts in patients who have had an insufficient response to corticosteroids or immunoglobulins.
  • Novartis announced the publication of a study conducted by the National Institutes of Health demonstrating that 58% of patients with treatment-naïve severe aplastic anemia achieved complete response at six months when treated with eltrombopag at the initiation of and concurrent with standard immunosuppressive treatment. The data are published in the latest issue of The New England Journal of Medicine.

Kyprolis® (carfilzomib), an Amgen Product Utilizing Captisol

  • On April 26, 2017, Amgen reported first quarter 2017 net sales of Kyprolis (carfilzomib) of $190 million, a $36 million or 23% increase over the same period in 2016.
  • On February 28, 2017, Amgen announced positive results from a planned overall survival (OS) interim analysis of the Phase 3 head-to-head ENDEAVOR trial. The study met the key secondary endpoint of OS, demonstrating that patients with relapsed or refractory multiple myeloma treated with Kyprolis (carfilzomib) and dexamethasone (Kd) lived 7.6 months longer than those treated with Velcade® (bortezomib) and dexamethasone (Vd) (median OS 47.6 months for Kd versus 40.0 for Vd, HR = 0.79, 95 percent CI, 0.65 – 0.96).
  • On March 1, 2017, Amgen announced that new data from the Kyprolis (carfilzomib) clinical development program would be presented at the 16th International Myeloma Workshop, March 1-4, 2017, in New Delhi.

Additional Pipeline and Partner Developments

  • Melinta Therapeutics announced that the new drug applications (NDAs) for IV and oral Baxdela™ (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) were accepted for filing by the Food and Drug Administration (FDA) and were granted a Prescription Drug User Fee Act (PDUFA) date of June 19, 2017. Additionally, Melinta announced that the FDA does not plan to hold an Advisory Committee meeting for the NDAs. If approved, Ligand is entitled to receive a 2.5% royalty on net sales of the IV formulation of Baxdela and a $1.5 million approval milestone payment.
  • Melinta Therapeutics announced signing a development and commercialization agreement with Menarini Group, granting Menarini exclusive rights to commercialize delafloxacin under its own brands in 68 countries in Europe, Asia-Pacific including China, South Korea and Australia (excluding Japan), and the Commonwealth of Independent States including Russia.
  • Retrophin announced plans to initiate a single Phase 3 clinical trial to enable an NDA filing for sparsentan for the treatment of focal segmental glomerulosclerosis. The trial will include an interim analysis of proteinuria as a surrogate endpoint to serve as the basis for an NDA filing for Subpart H accelerated approval of sparsentan. Retrophin expects to initiate the trial in the second half of 2017.
  • Sage Therapeutics presented brexanolone data at the American Academy of Neurology 2017 annual meeting.
  • Aldeyra provided an update on its Phase 3 clinical program of ADX-102 in noninfectious anterior uveitis and anticipates beginning the Phase 3 trial in the second quarter of 2017.
  • Aldeyra announced the last patient had completed dosing in Aldeyra's multicenter, double-blind, randomized Phase 2b clinical trial of ADX-102 in allergic conjunctivitis.
  • Biocad announced receiving marketing authorization from the Ministry of Health of the Russian Federation for its interferon beta-1a biosimilar of Merck’s Rebif®.
  • Merck announced 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 were 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.
  • Novartis announced that it had exercised an option to in-license ECF843 (Lubricin) for ophthalmic indications from Lubris Biopharma. Ligand acquired economic rights to the Lubricin program from Selexis, SA in 2015.
  • Opthea Limited announced positive results from its Phase 1/2a clinical trial of OPT-302 for wet age-related macular degeneration (wet AMD). Opthea is planning to initiate a Phase 2b trial in wet AMD and a Phase 2a trial in diabetic macular edema in the second half of 2017.
  • Viking Therapeutics announced positive initial results from a proof-of-concept study of VK2809 in an in vivo model of glycogen storage disease 1a (GSD 1a) and announced funding of initial clinical development of VK2809 for treatment of GSD 1a with plans to file an investigational new drug (IND) application in the second half of 2017.
  • Janssen filed an IND application for an antibody discovered using Ligand’s OmniAb technology. The IND filing resulted in a $1 million milestone payment to Ligand. Janssen has a royalty-free license to the OmniAb technology (entered into with OMT in October of 2013), but will potentially pay Ligand further development and commercial milestones upon clinical success and regulatory approval of any therapeutic developed using the OmniAb technology.
  • Marinus Pharmaceuticals presented Phase 1 clinical data showing the safety and tolerability of ganaxolone IV at the 6th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures.
  • Merck KGaA announced it licensed rights to develop Captisol-enabled VX-970 from Vertex Pharmaceuticals. Economic terms of the original agreement between Ligand and Vertex remained unchanged.
  • XTL Biopharmaceuticals announced the receipt of additional preclinical data regarding the role of hCDR1 as a potential treatment for Sjögren's syndrome from Prof. Edna Mozes of The Weizmann Institute of Science and the developer of hCDR1.

New Licensing Deals

  • Ligand announced a worldwide platform license agreement with bluebird bio, Inc. Under the license, bluebird will be able to use the OmniRat®, OmniMouse® and OmniFlic® platforms to discover fully human mono- and bispecific antibodies and antibody fragments. Ligand is eligible to receive annual platform access payments, development milestone payments and royalties for each product incorporating an OmniAb antibody. Bluebird will be responsible for all costs related to the programs. Ligand previously disclosed rights to a single-antibody partnership had been licensed to bluebird, but this new agreement gives bluebird full access to the OmniAb platform.
  • Ligand announced an expansion of its license with Sermonix Pharmaceuticals to include worldwide rights to develop and commercialize oral lasofoxifene. Ligand originally licensed U.S. rights to oral lasofoxifene to Sermonix in February of 2015, and has now expanded the agreement to include the rest of the world. Ligand is entitled to commercial milestones and royalties on net sales ranging from 6-10% upon commercialization of oral lasofoxifene.
  • Ligand announced a commercial license and supply agreement with Marinus Pharmaceuticals granting rights to use Captisol in the formulation of IV ganaxolone. Ligand is entitled to milestone payments, royalties and revenue from Captisol material sales related to IV ganaxolone.
  • Ligand entered into a Captisol Clinical Use/Supply Agreement with Eisai.

Internal Glucagon Receptor Antagonist (GRA) Program

  • Ligand announced the completion of enrollment in the Company’s Phase 2 clinical trial with its novel, small-molecule GRA program (LGD-6972) for the treatment of type 2 diabetes mellitus. The Company expects to report topline results in September 2017.

Adjusted Financial Measures

The Company reports adjusted net income and adjusted net income per diluted share, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company’s financial measures under GAAP include stock-based compensation expense, amortization of debt-related costs, amortization related to acquisitions, changes in contingent liabilities, net losses of Viking Therapeutics, mark-to-market adjustment for amounts owed to licensors, fair value adjustments to Viking Therapeutics convertible note receivable and warrants, unissued shares relating to the Senior Convertible Note, and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included in this press release. However, other than with respect to total revenue, the Company only provides guidance on an adjusted basis and does not provide reconciliations of such forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in contingent liabilities, net losses of Viking Therapeutics, mark-to-market adjustments for amounts owed to licensors, effects of any discrete income tax items and fair value adjustments to Viking Therapeutics convertible note receivable. Management has excluded the effects of these items in its adjusted measures to assist investors in analyzing and assessing the Company’s past and future core operating performance. Additionally, adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

Conference Call

Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (877) 407-4019 from the U.S. or (201) 689-8337 from outside the U.S., using the passcode “Ligand.” To participate via live or replay webcast, a link will be available at www.ligand.com.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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 affairs and commercialization) to ultimately generate our revenue. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono- and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding: Ligand’s future revenue growth, including the timing, mix and volume of Captisol orders, the timing of the initiation or completion of clinical trials by Ligand and its partners, the timing of regulatory filings with the FDA and other regulatory agencies, the timing of new product launches by Ligand and its partners and the related royalties Ligand expects to receive from its partners, the timing of review of clinical data by the FDA, expected value creation for shareholders and guidance regarding the full-year 2017 financial results. Actual events or results may differ from Ligand's expectations. For example, Ligand may not receive expected revenue from material sales of Captisol, expected royalties on other partnered products and research or development milestone payments. Ligand and its partners may not be able to timely or successfully advance any product(s) in its internal or partnered pipeline. In addition, there can be no assurance that Ligand will achieve its guidance for 2017 or any portion thereof or beyond, that Ligand's 2017 revenues will be at the levels as currently anticipated, that Ligand will be able to create future revenues and cash flows by developing innovative therapeutics, that results of any clinical study will be timely, favorable or confirmed by later studies, that products under development by Ligand or its partners will receive regulatory approval, that there will be a market for the product(s) if successfully developed and approved, or that Ligand's partners will not terminate any of its agreements or development or commercialization of any of its products. Further, Ligand may not generate expected revenues under its existing license agreements and may experience significant costs as the result of potential delays under its supply agreements. Also, Ligand and its partners may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result in increased costs and delays, or limit Ligand's ability to obtain regulatory approval. Further, unexpected adverse side effects or inadequate therapeutic efficacy of Ligand's product(s) could delay or prevent regulatory approval or commercialization. In addition, Ligand may not be able to successfully implement its strategic growth plan and continue the development of its proprietary programs. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Other Disclaimers and Trademarks

The information in this press release regarding certain third-party products and programs, including Promacta, a Novartis product, and Kyprolis, an Amgen product, comes from information publicly released by the owners of such products and programs. Ligand is not responsible for, and has no role in, the development of such products or programs.

Ligand owns or has rights to trademarks and copyrights that it uses in connection with the operation of its business including its corporate name, logos and websites. Other trademarks and copyrights appearing in this press release are the property of their respective owners. The trademarks Ligand owns include Ligand®, Captisol® and OmniAb®. Solely for convenience, some of the trademarks and copyrights referred to in this press release are listed without the ®, © and TM symbols, but Ligand will assert, to the fullest extent under applicable law, its rights to its trademarks and copyrights.

 
LIGAND PHARMACEUTICALS, INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in thousands, excluding per-share data)

 
Three Months Ended March 31,
2017   2016
Revenues:
Royalties $ 24,230 $ 14,390
Material sales 1,121 5,341
License fees, milestones and other revenues 3,916   9,917  
Total revenues 29,267 29,648
Operating costs and expenses:
Cost of goods sold 341 955
Amortization of intangibles 2,715 2,524
Research and development 8,673 4,004
General and administrative 7,322   7,069  
Total operating costs and expenses 19,051   14,552  
Income from operations 10,216 15,096
Other expense, net (2,800 ) (2,614 )
Increase in contingent liabilities (140 ) (1,306 )
Loss from Viking (1,083 ) (1,605 )
Total other expense, net (4,023 ) (5,525 )
Income before income taxes 6,193 9,571
Income tax expense (1,114 )   (3,694 )
Income from continuing operations 5,079     5,877  
Income from discontinued operations, net of taxes   731  
Net income: $ 5,079   $ 6,608  
 
Basic per-share amounts:
Income from continuing operations $ 0.24 $ 0.28
Discontinued operations   0.04  
Net income $ 0.24   $ 0.32  
Diluted per-share amounts:
Income from continuing operations $ 0.22 $ 0.26
Discontinued operations   0.03  
Net income $ 0.22   $ 0.30  
 
Weighted average number of common shares-basic 20,937,627 20,707,926
Weighted average number of common shares-diluted 23,019,189 22,283,979
 
 
LIGAND PHARMACEUTICALS, INCORPORATED
CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited, in thousands)

   
March 31, 2017 December 31, 2016
Assets
Current assets:
Cash, cash equivalents and short-term investments $ 159,374 $ 141,048
Note receivable from Viking 3,207
Inventory 7,629 1,923
Other current assets 641   2,175
Total current assets 174,701 163,053
 
Deferred income taxes 140,843 123,891
Goodwill and other identifiable intangible assets 274,197 276,912
Investment in Viking 7,262 8,345
Note receivable from Viking 3,207
Commercial license rights 25,630 25,821
Property and equipment, net 1,898 1,819
Other assets 1,821   1,744
Total assets $ 629,559   $ 601,585
 
Liabilities and Stockholders' Equity
Current contingent liabilities $ 111 $ 5,088
Accounts payable and accrued liabilities 11,136 9,131
Short-term debt 215,748   212,910
Total current liabilities 226,995 227,129
 
Long-term portion of contingent liabilities 3,035 2,916
Other long-term liabilities 915   687
Total liabilities 230,945 230,732
Equity component of currently redeemable convertible notes 26,948   29,563
Total Ligand Pharmaceuticals stockholders' equity 371,666   341,290
Total liabilities and stockholders' equity $ 629,559   $ 601,585
 
 
LIGAND PHARMACEUTICALS INCORPORATED
ADJUSTED FINANCIAL MEASURES

(Unaudited, in thousands, excluding per-share data)

 
Three months ended March 31,
2017   2016
 
 
Net income $ 5,079 $ 6,608
Stock-based compensation expense 6,045 4,118
Non-cash interest expense(1) 2,838 2,669
Amortization related to acquisitions 2,906 2,532
Loss from Viking 1,083 1,605
Increase in contingent liabilities(2) 140 1,306
Other(3) (85 ) (205 )
Income tax effect of adjusted reconciling items above (4,482 ) (4,267 )
Excess tax benefit from stock-based compensation(4) (875 )
Discontinued operations, net of tax   (731 )
Adjusted net income from continuing operations $ 12,649   $ 13,635  
Diluted per-share amounts attributable to common shareholders:
Net income $ 0.22 $ 0.30
Stock-based compensation expense 0.26 0.18
Non-cash interest expense(1) 0.12 0.12
Amortization related to acquisitions 0.13 0.11
Loss from Viking 0.05 0.07
Increase in contingent liabilities(2) 0.01 0.06
Other(3) (0.01 )
Income tax effect of adjusted reconciling items above (0.19 ) (0.19 )
Excess tax benefit from stock-based compensation(4) (0.04 )
Discontinued operations, net of tax (0.03 )
2019 Senior Convertible Notes share count adjustment 0.02   0.02  
Adjusted net income from continuing operations $ 0.57   $ 0.63  
 
Weighted average shares used in calculation of GAAP diluted earnings per share 23,019 22,284
Weighted average dilutive potential common shares issuable of 2019 Senior Convertible Notes 941 750
Weighted average shares used in calculation of adjusted diluted earnings per share 22,078 21,534
(1)   Non-cash debt related costs is calculated in accordance with the authoritative accounting guidance for convertible debt instruments that may be settled in cash.
 
(2) Changes in fair value of contingent consideration related to CyDex and Metabasis transactions.
 
(3) Amounts due to Bristol-Myers Squibb relating to the Retrophin license agreement and fair market value adjustment on Viking note and warrants.
 
(4) Excess tax benefits from stock-based compensation are recorded as a discrete item within the provision for income taxes on the consolidated statement of income pursuant to ASU 2016-09, which was previously recognized in additional paid-in capital on the consolidated statement of stockholders’ equity.

Ligand Pharmaceuticals Incorporated
Todd Pettingill, 858-550-7500
investors@ligand.com
Twitter: @Ligand_LGND
or
LHA
Bruce Voss, 310-691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

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Ligand to Report First Quarter 2017 Results on May 9th http://investor.ligand.com/news/detail/322/ligand-to-report-first-quarter-2017-results-on-may-9th Thu, 13 Apr 2017 09:00:00 -0400 http://investor.ligand.com/news/detail/322/ligand-to-report-first-quarter-2017-results-on-may-9th

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today plans to report first quarter 2017 financial results on May 9, 2017. Ligand’s CEO John Higgins, President and COO Matt Foehr and CFO Matt Korenberg will host the conference call.

First Quarter 2017 Earnings Call

What:

   

Ligand conference call to discuss financial results and provide general business updates

 
When: Tuesday, May 9, 2017
 
Time: 4:30 p.m. Eastern time (1:30 p.m. Pacific time)
 
Conference Call: (877) 407-4019 within the U.S.
(201) 689-8337 outside the U.S.
Passcode: Ligand
 
Webcast:

Live conference call webcast and replay accessible at www.ligand.com

 

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Ligand Pharmaceuticals Incorporated
Todd Pettingill, 858-550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Bruce Voss, 310-691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

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Ligand Enters Commercial License and Supply Agreements with Marinus Pharmaceuticals for Captisol-Enabled Ganaxolone http://investor.ligand.com/news/detail/321/ligand-enters-commercial-license-and-supply-agreements-with-marinus-pharmaceuticals-for-captisol-enabled-ganaxolone Wed, 05 Apr 2017 09:00:00 -0400 http://investor.ligand.com/news/detail/321/ligand-enters-commercial-license-and-supply-agreements-with-marinus-pharmaceuticals-for-captisol-enabled-ganaxolone

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that it has entered into commercial License and Supply Agreements (License Agreement) with Marinus Pharmaceuticals, Inc., granting rights to use Ligand’s Captisol in the formulation of its intravenous (IV) ganaxolone. Captisol is a patent protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Marinus is preparing to initiate clinical trials with Captisol-enabled ganaxolone IV in patients with postpartum depression (PPD) and status epilepticus (SE).

This License Agreement replaces the prior research agreement which allowed Marinus to evaluate ganaxolone IV with Captisol in preclinical and Phase 1 clinical studies. Under this new agreement, Marinus receives exclusive worldwide rights to Captisol-enabled ganaxolone for use in humans. In addition to an upfront payment, Ligand is entitled to potential milestone payments, royalties and revenue from future sales of Captisol-enabled ganaxolone.

“This agreement allows Captisol-enabled ganaxolone to go into later-stage testing and potential commercialization in indications that have significant unmet clinical needs,” said John Higgins, Chief Executive Officer of Ligand Pharmaceuticals. “Ligand’s portfolio of fully-funded shots on goal continues to grow and contains a large number of Captisol-enabled drugs. We continue to be encouraged by the recent progress of our partners, including Marinus.”

“Ganaxolone IV formulated with Captisol has produced a good safety, tolerability, and toxicity profile in preclinical and Phase 1 testing,” commented Christopher M. Cashman, President and Chief Executive Officer of Marinus Pharmaceuticals. “We look forward to moving ganaxolone IV into Phase 2 clinical trials in patients with PPD and SE this year.”

About Ganaxolone

Ganaxolone, a positive allosteric modulator of GABAA, is being developed in three different dose forms (intravenous, capsule, and liquid) intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Ganaxolone exhibits antiseizure and antianxiety actions via its effects on synaptic and extrasynaptic GABAA receptors. Ganaxolone has been studied in more than 1,500 subjects, both pediatric and adult, at therapeutically relevant dose levels and treatment regimens for up to two years. In these studies, ganaxolone was generally safe and well tolerated. The most commonly reported adverse events were somnolence, dizziness and fatigue.

About Marinus Pharmaceuticals, Inc.

Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS) is a biopharmaceutical company dedicated to the development of ganaxolone, which offers a new mechanism of action, demonstrated efficacy and safety, and convenient dosing to improve the lives of patients suffering from epilepsy and neuropsychiatric disorders. Ganaxolone is a positive allosteric modulator of GABAA that acts on a well-characterized target in the brain known to have both antiseizure and antianxiety effects. Ganaxolone is being developed in three different dose forms (IV, capsule and liquid) intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Marinus is currently evaluating ganaxolone in orphan pediatric indications for the treatment of genetic seizure and behavior disorders, and preparing to initiate Phase 2 studies in status epilepticus, an orphan indication, and postpartum depression. For more information visit www.marinuspharma.com.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These include statements regarding Marinus’ planned development of Captisol-enabled intravenous ganaxolone including the target indications. Actual events or results may differ from our expectations. For example, Marinus may choose to abandon Captisol-enabled intravenous ganaxolone; Marinus’ clinical development plan may fail for a variety of reasons beyond Ligand’s and Marinus’ control including increased costs or company priorities; the safety, tolerability and efficacy data from a new clinical trial or other study in Captisol-enabled intravenous ganaxolone may conflict with the results of prior clinical trials; or Captisol-enabled intravenous ganaxolone might not be successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other important risk factors affecting Ligand can be found in Ligand's prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission, available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Ligand Pharmaceuticals Incorporated
Todd Pettingill, 858-550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Bruce Voss, 310-691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

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Ligand Announces Licensing Partner Janssen Has Filed an IND for an Antibody Discovered Using the OmniAb® Technology http://investor.ligand.com/news/detail/320/ligand-announces-licensing-partner-janssen-has-filed-an-ind-for-an-antibody-discovered-using-the-omniab-technology Tue, 28 Mar 2017 09:00:00 -0400 http://investor.ligand.com/news/detail/320/ligand-announces-licensing-partner-janssen-has-filed-an-ind-for-an-antibody-discovered-using-the-omniab-technology

IND filing results in $1 million milestone payment to Ligand

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that CNA Development LLC, an affiliate of Janssen Pharmaceuticals, Inc. (Janssen) has filed an IND for an antibody discovered using Ligand’s OmniAb technology. This IND filing results in a $1 million milestone payment to Ligand.

“This milestone represents an important step in the development process and is the second IND filed with the FDA for an antibody discovered with the OmniAb technology,” said John Higgins, Chief Executive Officer of Ligand. “Ligand acquired the OmniAb technology platform in January of 2016 and has since entered into multiple new licensing agreements for the technology. This IND filing represents continued value creation from the OmniAb acquisition and continues to build on Ligand’s shots-on-goal business model.”

Janssen gained access to the OmniAb platform in October of 2013 and is able to use the OmniRat®, OmniMouse® and OmniFlic® platforms to discover fully human mono- and bispecific antibodies. Ligand is eligible to receive development milestone payments and royalties for each product incorporating an OmniAb antibody. Janssen is responsible for all costs related to the programs.

About OmniAb®

OmniAb includes three transgenic animal platforms for producing mono- and bispecific human therapeutic antibodies. OmniRat® is the industry’s first human monoclonal antibody technology based on rats. It has a complete immune system with a diverse antibody repertoire and generates antibodies with human idiotypes as effectively as wild-type animals make rat antibodies. OmniMouse® is a transgenic mouse that complements OmniRat and expands epitope coverage. OmniFlic® is an engineered rat with a fixed light chain for development of bispecific, fully human antibodies. The three platforms use patented technology, have broad freedom to operate and deliver fully human antibodies with high affinity, specificity, expression, solubility and stability.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These include statements regarding Ligand's license agreement with Jannsen under which Ligand may receive milestone payments and royalties. Actual events or results may differ from our expectations. For example, there can be no assurances that the FDA will approve the IND filed by Janssen; Janssen may choose to delay or abandon their program related to the OmniAb antibodies, including for reasons beyond Janssen’s control; and Janssen may not successfully develop or market any antibodies discovered under the license agreement. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other important risk factors affecting Ligand can be found in Ligand's prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission, available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Ligand Pharmaceuticals Incorporated
Todd Pettingill
858-550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Bruce Voss
310-691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

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Ligand to Participate in Upcoming Investor Conference http://investor.ligand.com/news/detail/319/ligand-to-participate-in-upcoming-investor-conference Thu, 09 Mar 2017 08:00:00 -0500 http://investor.ligand.com/news/detail/319/ligand-to-participate-in-upcoming-investor-conference

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that company executives are scheduled to participate in the following upcoming investor conference:

  • 29th Annual ROTH Conference in Laguna Niguel, California. Presentation takes place on Tuesday, March 14, 2017 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time). John Higgins, CEO and Matt Foehr, President and COO will present for Ligand.

A live webcast of the presentation will be available on Ligand’s website at www.ligand.com. A replay of the presentation will be archived on the website for 30 days.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Ligand Pharmaceuticals Incorporated
Todd Pettingill
(858) 550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Bruce Voss
(310) 691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

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Ligand Provides Highlights from Today’s Analyst Day Event http://investor.ligand.com/news/detail/318/ligand-provides-highlights-from-todays-analyst-day-event Tue, 28 Feb 2017 16:10:00 -0500 http://investor.ligand.com/news/detail/318/ligand-provides-highlights-from-todays-analyst-day-event

Webcast available at www.ligand.com

SAN DIEGO--(BUSINESS WIRE)-- At an Analyst Day event held today in New York City, Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) reviewed the recent progress of its business, its revenue growth opportunities and its portfolio of partnered assets and unpartnered development programs. Management also discussed the OmniAb and Captisol discovery and formulation technologies as well as its financial outlook for 2017.

Highlights of presentations by Ligand’s senior management include the following:

Business model and growth drivers:

  • Ligand has more than 155 fully-funded programs in partnership with more than 92 different pharmaceutical and biotechnology companies, and is eligible to receive over $2 billion in milestone payments based on success. 14 products have been approved and are generating commercial revenue for Ligand today, and the company projects that in 2020 more than 28 products from its portfolio will be commercialized and generating revenue for Ligand.
  • Ligand estimates that in 2017 its partners will spend more than $2 billion on R&D to advance partnered programs, including funding 32 Phase 3 trials and 39 Phase 2 trials.
  • Global product sales by partners on which Ligand is entitled to receive royalty payments are projected to be approximately $1.9 billion in 2017. The blended average royalty rate to Ligand during this period is expected to be close to 4.6% of net sales.
  • Ligand identified major growth drivers that could occur in 2017 including;
    • Results from Ligand’s Phase 2 trial of GRA (LGD-6972) in type 2 diabetes
    • Update on Retrophin’s approval pathway for Sparsentan
    • Completion of Viking Therapeutics’ Phase 2 trial of VK5211 (SARM) in hip fracture
    • Potential approval of Melinta Therapeutics’ BAXDELA
    • Completion of Viking Therapeutics’ Phase 2 trial of VK2809 (TRβ) in hypercholesterolemia and fatty liver disease
    • Potential approval of Sage Therapeutics’ brexanolone (SAGE-547)

Asset portfolio review:

  • Promacta® sales have continued to grow under Novartis, surpassing $600 million in annual sales in 2016 for the first time ever, and pushing into the top of the tiered royalty structure earlier in the year. The drug is approved to treat idiopathic thrombocytopenia in over 100 countries, thrombocytopenia induced by Hepatitis C in over 50 countries and aplastic anemia in over 45 countries. 23 clinical trials are ongoing to potentially expand Promacta indications to include MDS (Phase 2), chemotherapy-induced thrombocytopenia (Phase 2) and others.
  • Kyprolis®, developed and marketed by Amgen, for the treatment of multiple myeloma, which uses Captisol in its formulation, has also shown significant growth, with worldwide sales reaching close to $700 million in 2016. Kyprolis was approved to be marketed in Japan by Ono Pharmaceutical Co in 2016. Trials are ongoing to further expand Kyprolis’ label including a Phase 3 trial in combination with Darzalex which is expected to begin in the second quarter of 2017.
  • Management provided an update on the Big 6, which now includes the following programs:
    • Melinta Therapeutics’ NDA stage BAXDELA for treatment of infection
    • Retrophin’s Phase 2/3 Sparsentan for treatment of focal segmental glomerulosclerosis (FSGS)
    • Sage Therapeutics’ Phase 3 brexanolone for treatment of super-refractory status epilepticus and also for post-partum depression
    • Sermonix Pharmaceuticals’ Phase 2/3 lasofoxifene for oncology and women’s health
    • Bristol-Myers Squibb’s Phase 2/3 BMS986231 for treatment of cardiovascular disease
    • Eli Lilly’s Phase 2 prexasertib for various oncology indications
  • Management also provided an update to the Next 12, which now includes the following drug types: oncology (6), metabolic disease (2), cardiovascular (1), inflammation (1) specialty (1) and biosimilar (1).
  • Additionally, Ligand provided updated metrics to describe the portfolio as a whole, noting;
    • 33% are in Phase 2 development or later
    • Captisol programs make up more than a third of the portfolio, with Selexis programs making up a quarter and current OmniAb programs making up a fifth
    • The portfolio is widely diversified across indications but also has a significant number of oncology programs
  • GRA is Ligand’s proprietary glucagon receptor antagonist in development as an oral treatment for type 2 diabetes (T2DM), which recently completed enrollment of its ongoing Phase 2 trial. At the Analyst Day event management discussed the growing need for novel treatments for T2DM and GRA’s positive safety and efficacy profile. The company expects topline results in September 2017.
  • Ligand also highlighted the strength of the intellectual property protecting its portfolio and technologies, with over 700 worldwide issued patents.

Underlying technologies review:

  • Management gave an update on the progress of Captisol, highlighting that since Ligand’s acquisition of CyDex in 2011, over 450 research and animal use agreements have been executed with potential partners, and that the number of inbound requests for Captisol samples passed 800 for the first time in 2016. Captisol has patent-protection through 2033 in major markets.
  • Roland Buelow, Ph.D., VP of Antibody Technologies and founder of Ligand-acquired OMT Technologies and inventor of the OmniAb technology platform, discussed the growing number of antibody therapeutics in development and the novel approach of the OmniAb platform. To date, OmniAb partners have initiated over 300 discovery projects with the technology, and Ligand estimates that approximately 30 OmniAb-discovered antibodies will enter the clinic in the next five years. By 2027, Ligand estimates that over 50 Phase 1 trials will be completed or in-process, with multiple Phase 2 and Phase 3 trials ongoing, three or more OmniAb therapeutics on the market and cumulative revenue received at that time of over $300 million.

Financial outlook:

  • Management highlighted Ligand’s recent history of significant revenue growth, sustained low cash operating expenses and resulting strong EBITDA and cash flow generation.
  • Ligand also reiterated and gave additional detail regarding recent core revenue and core adjusted EPS guidance for 2017 as follows:
    • Core royalties are projected to be $87 million, taken from a range of $80 million to $95 million that is calculated based on applying contractual royalty rates to sell-side analyst estimates.
    • Core materials sales are projected to be $23 million, which shows continued growth over prior years when normalizing historical sales to remove historical lumpy ordering patterns of a significant customer.
    • Core milestone and license revenues are projected to be $20 million, with potential upside of an additional $30 million of milestones including; licensing/financing, NDA-related, trial start and other types of milestones.
    • Based on core revenue of $130 million, adjusted EPS is expected to be $2.70, although this amount could increase based on potential receipt of upside milestones beyond $20 million.
  • Management also reiterated its projected cash operating expense structure of $28 million to $30 million, which implies 2017 EBITDA of $96 million, compared to $74 million in 2016 or a 30% increase.
  • Ligand reiterated that the 2017 tax rate for adjusted EPS is expected to be between 36% and 39%, although the actual cash tax rate is expected to be less than 1%.
  • Management also provided a general outlook through 2020, which included the expectation that:
    • Royalties grow in line with consensus sell-side research
    • Milestones continue at a core level of $20 million - $30 million, with potential upside
    • Materials grow at a 5% - 10% CAGR
    • Cash operating expense expected to be relatively flat with only modest annual increases
    • Fully-diluted share count projected to grow at 0.2 million shares annually
    • Adjusted EPS tax rate continues to be between 36% and 39%, while actual cash tax rate is less than 1% through 2020

A webcast of the Analyst Day presentations can be accessed at www.ligand.com for the next 90 days.

Adjusted Financial Measures

The company reports adjusted results for diluted net income per share and net income, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The company’s financial measures under GAAP include stock-based compensation expense, amortization of debt-related costs, amortization related to acquisitions, changes in contingent liabilities, net losses of Viking Therapeutics, mark-to-market adjustment for amounts owed to licensors, fair value adjustments to Viking Therapeutics convertible note receivable and warrants, unissued shares relating to the Senior Convertible Note, unissued shares relating to the anti-dilutive effect of fourth quarter and fiscal year 2016 GAAP net loss and adjustments for discontinued operations, and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included in this press release. However, other than with respect to total revenue, the Company only provides guidance on an adjusted basis and does not provide reconciliations of such forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in contingent liabilities, net losses of Viking Therapeutics, mark-to-market adjustments for amounts owed to licensors and fair value adjustments to Viking Therapeutics convertible note receivable. Management has excluded the effects of these items in its adjusted measures to assist investors in analyzing and assessing the Company’s past and future core operating performance. Additionally, adjusted diluted earnings per share is a key component of the financial metrics utilized by the company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding: growth in the number of products in Ligand’s portfolio, the research and development expenditures of Ligand’s partners, the average royalty rate expected based on sales by Ligand’s partners, Ligand’s future revenues and other projected financial measures, the timing and results of Ligand’s clinical trials and clinical trials to be conducted by Ligand’s partners, Ligand’s expected tax rate, Ligand’s projected operational and financial results, and guidance regarding 2017 financial results. Actual events or results may differ from Ligand's expectations. For example, Ligand may not receive expected revenue from material sales of Captisol, expected royalties on partnered products and research and development milestone payments. Ligand and its partners may not be able to timely or successfully advance any product(s) in its internal or partnered pipeline. In addition, there can be no assurance that Ligand will achieve its guidance for 2017 or any portion thereof or beyond, that Ligand's 2017 revenues will be at the levels or be broken down as currently anticipated, that Ligand will be able to create future revenues and cash flows by developing innovative therapeutics, that results of any clinical study will be timely, favorable or confirmed by later studies, that products under development by Ligand or its partners will receive regulatory approval, that there will be a market for the product(s) if successfully developed and approved, or that Ligand's partners will not terminate any of its agreements or development or commercialization of any of its products. Further, Ligand may not generate expected revenues under its existing license agreements and may experience significant costs as the result of potential delays under its supply agreements. Also, Ligand and its partners may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result in increased costs and delays, or limit Ligand's ability to obtain regulatory approval. Further, unexpected adverse side effects or inadequate therapeutic efficacy of Ligand's product(s) could delay or prevent regulatory approval or commercialization. In addition, Ligand may not be able to successfully implement its strategic growth plan and continue the development of its proprietary programs. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Ligand Pharmaceuticals Incorporated
Todd Pettingill, 858-550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Bruce Voss, 310-691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

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Ligand Expands License with Sermonix to Include Worldwide Rights for Oral Lasofoxifene http://investor.ligand.com/news/detail/317/ligand-expands-license-with-sermonix-to-include-worldwide-rights-for-oral-lasofoxifene Tue, 28 Feb 2017 16:01:00 -0500 http://investor.ligand.com/news/detail/317/ligand-expands-license-with-sermonix-to-include-worldwide-rights-for-oral-lasofoxifene

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that it has expanded its license with Sermonix Pharmaceuticals to include worldwide rights to develop and commercialize oral lasofoxifene. Ligand originally licensed the U.S. rights to oral lasofoxifene to Sermonix in February of 2015, and has now expanded the agreement to include the rest of the world. Sermonix is focused on breast and ovarian cancer treatment with oral lasofoxifene, particularly an indication in the treatment of advanced Estrogen Receptor positive (ER+) endocrine-resistant breast cancer.

“Lasofoxifene is an asset with a rich heritage originating at Ligand and with a substantial set of global clinical data. This agreement with Sermonix represents an expansion of our relationship and enables further development of oral lasofoxifene on a worldwide basis,” said John Higgins, Chief Executive Officer of Ligand Pharmaceuticals. “This amendment includes an upfront payment, additional commercial milestones and 6% to 10% royalties on ex-US sales and is consistent with our shots-on-goal business model of partnering the development of our assets to create a robust pipeline with limited required R&D spending by Ligand.”

About Lasofoxifene and Ligand’s Lasofoxifene Partnerships

Lasofoxifene was discovered through a research collaboration between Ligand and Pfizer that began in 1991. The oral, 0.5 mg form of lasofoxifene tartrate was developed by Pfizer under the trade name Fablyn®, and progressed through regulatory approval in the EU. After Pfizer acquired Wyeth and its drug Conbriza® (bazedoxifene), a similar SERM program, rights to all forms of lasofoxifene reverted to Ligand in 2011. In 2013 Ligand licensed lasofoxifene to Azure Biotech for the development of a novel formulation targeting an underserved market in women's health. Also in 2013, Ligand licensed to Ethicor Pharmaceuticals Ltd rights to manufacture and distribute oral lasofoxifene as an unlicensed medicinal product in the European Economic Area, Switzerland and the Indian Subcontinent. Ligand and Ethicor mutually terminated that agreement in early 2017.

About Sermonix Pharmaceuticals

Sermonix Pharmaceuticals LLC is a biotechnology company with a targeted focus on bringing female-specific oncology products through proof of concept, clinical development, and regulatory approval. The company was founded in 2014 by David Portman, MD, a leading clinical researcher and expert in women's health, menopause and selective estrogen receptor modulator (SERM) therapy. Sermonix has as its lead product oral lasofoxifene, with exclusive worldwide licensing rights obtained from Ligand Pharmaceuticals, Inc. (NASDAQ: LGND). The Sermonix internal management team, led by Dr. Portman, has significant experience in all stages of the drug development and regulatory process. James Symons, MS, PhD, is Vice President of Clinical Development at Sermonix, and led the global lasofoxifene VVA program while at Pfizer. Paul Plourde, MD, VP Sermonix Oncology Clinical Development, was previously with Astra-Zeneca, where he was instrumental in the development and approval of tamoxifen, Arimidex® and Faslodex®. Barry Komm, PhD, Sermonix Chief Scientific Officer, was former head of the SERM program at Wyeth and Pfizer, playing a key role in the development and approval of bazedoxifene and Duavee®. Elizabeth Attias, MMSc, ScD, is Vice President of Business Development. Miriam Portman, M.D., is the Chief Operating Officer of Sermonix. She is former Co-director and Founder of the Columbus Center for Women's Health Research. Sermonix Non-Executive Chairman of the Board is Anthony Wild, PhD, former president of both Parke-Davis Pharmaceuticals and Warner-Lambert's Pharmaceutical Division.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These include statements regarding Sermonix’s planned development of lasofoxifene including the target indications. Actual events or results may differ from our expectations. For example, Sermonix may choose to abandon lasofoxifene or may choose a different target indication; Sermonix’s clinical development plan may fail for a variety of reasons beyond Ligand’s and Sermonix’s control including increased costs or company priorities; and the safety, tolerability and efficacy data from a new clinical trial or other study in lasofoxifene may conflict with the results of prior clinical trials. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other important risk factors affecting Ligand can be found in Ligand's prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission, available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Ligand Pharmaceuticals Incorporated
Todd Pettingill, 858-550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Bruce Voss, 310-691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

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Enrollment Completed in Ligand’s Phase 2 Trial of LGD-6972 in Type 2 Diabetes http://investor.ligand.com/news/detail/316/enrollment-completed-in-ligands-phase-2-trial-of-lgd-6972-in-type-2-diabetes Mon, 27 Feb 2017 09:00:00 -0500 http://investor.ligand.com/news/detail/316/enrollment-completed-in-ligands-phase-2-trial-of-lgd-6972-in-type-2-diabetes

Ligand expects to report topline results in September 2017

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announces the completion of enrollment in the Company’s Phase 2 clinical trial with its novel, small-molecule glucagon receptor antagonist LGD-6972 for the treatment of type 2 diabetes mellitus (T2DM). This randomized, double-blind, placebo-controlled study is evaluating 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. The Company expects to report topline results in September 2017.

In this Phase 2 study, subjects with T2DM are being treated with one of three doses of LGD-6972 (5 mg, 10 mg, or 15 mg) or placebo once daily for 12 weeks. The primary endpoint is change from baseline in hemoglobin A1c (HbA1c). Secondary endpoints include change from baseline in fasting plasma glucose, insulin, glucagon and GLP-1, as well as changes in lipids, blood pressure and body weight. In a subset of subjects, an oral glucose tolerance test is also being conducted at baseline and at the end of treatment.

“We are pleased with the rapid enrollment of patients, an accomplishment that enables us to report topline data by the end of the third quarter of 2017, ahead of our timeline projections,” said John Higgins, Chief Executive Officer. “Antagonism of the glucagon pathway is one of the most promising new therapeutic approaches for type 2 diabetes, and we believe LGD-6972 has potential valuable therapeutic properties. We look forward to obtaining data later this year, and to exploring potential partnerships for this program, consistent with our shots-on-goal business model.”

Based on Phase 1 trial results that were published in Diabetes, Obesity and Metabolism in January 20171, Ligand believes LGD-6972 holds potential to have promising and differentiating properties given its potency in lowering plasma glucose in patients with T2DM and its preliminary safety profile.

About Ligand’s Glucagon Receptor Antagonist Program

Glucagon is a hormone produced by the pancreas that stimulates the liver to produce glucose (sugar). Overproduction of glucose by the liver is an important cause of high glucose levels in patients with T2DM and is believed to be due in part to inappropriately elevated levels of glucagon. Glucagon receptor antagonists (GRA) are designed to lower glucose levels by reducing the production of glucose by the liver. GRAs are novel molecules that have demonstrated a reduction of glucose and HbA1c in mid-stage clinical trials.

Preclinical studies have shown that LGD-6972 is highly potent and selective, that it inhibits glucagon-induced hyperglycemia in both rats and monkeys and that it also significantly lowers glucose in a mouse model of T2DM. Additionally, LGD-6972 significantly lowered fasting and non-fasting glucose levels in a mouse model of type 1 diabetes and reduced HbA1c, ketone bodies and free fatty acids. LGD-6972 also has been shown to have additive effects when used in combination with insulin therapy and may be useful in an insulin-sparing regimen.

About Diabetes

Diabetes is a growing global epidemic that as of 2015 affected more than 415 million people worldwide2. In North America, approximately 44 million people have diabetes2. If current trends continue, by 2050 fully 33% of the U.S. population will be affected3. People with T2DM either are resistant to the effects of insulin or do not produce enough insulin to maintain a normal glucose level. Sustained high glucose levels can cause diabetic complications such as heart disease, stroke, kidney failure, neuropathy, lower-limb amputations and blindness. Although T2DM is more common in adults, it increasingly affects children as childhood obesity increases. An estimated 90% to 95% of Americans with diabetes have T2DM4.

The global market for diabetes drugs is expected to nearly double to $68 billion by 20225 as treatment paradigms shift toward combination therapies and novel non-insulin drugs. Global sales of the top 10 non-insulin diabetes drugs exceeded $15 billion in 2016 and are expected to increase to $20 billion by 20206.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These include statements regarding the timing of the release of topline results from the Phase 2 clinical trial of LGD-6972 with subjects with T2DM, the potential for LGD-6972 to treat patients with T2DM, the potential for LGD-6972 to exhibit best-in-class properties, Ligand’s ability to partner the program in the future, the number of patients affected by diabetes, the annual total sales of non-insulin diabetes drugs and the expected future sales of such drugs. Actual events or results may differ from our expectations. For example, patients in the Phase 2 clinical trial could drop out during the course of treatment which require additional enrollment to complete the Phase 2 clinical trial; the timing of the data from our third party clinical contractors could be delayed due to circumstances beyond Ligand’s control; Ligand could require additional time to analyze the data prior to release; the clinical trial could fail to reach its primary or secondary endpoints which could result in Ligand’s inability to partner the program; and the safety and tolerability data from a new clinical trial in LGD-6972 may conflict with the results of the Phase 1 clinical trials; the number of patients diagnosed with diabetes may be more or fewer than Ligand believes; and the total sales of non-insulin diabetes drugs is dependent on market acceptance of such drugs. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other important risk factors affecting Ligand can be found in Ligand's prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission, available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

References

1. Eric G. Vajda, et al. Pharmacokinetics and pharmacodynamics of single and multiple doses of the glucagon receptor antagonist LGD-6972 in healthy subjects and subjects with type 2 diabetes mellitus, Diabetes Obes Metab 2017; 19(1):24–32.

2. Diabetes: Facts and Figures. International Diabetes Federation website. http://www.idf.org/about-diabetes/facts-figures.

3. James P Boyle, et al. Projection of the year 2050 burden of diabetes in the U.S. adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. American Diabetes Association, Population Health Metrics. 2010 Oct 22;8:29

4. 2014 National Diabetes statistics report. Centers for Disease Control and Prevention website. http://www.cdc.gov/diabetes/data/statistics/2014StatisticsReport.html.

5. Type 2 Diabetes-Global Drug Forecast & Market Analysis to 2022. GlobalData

6. Thomson Reuters Cortellis, 2020 sales based on analyst consensus projections, 2016

Ligand Pharmaceuticals Incorporated
Todd Pettingill, 858-550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Bruce Voss, 310-691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

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Ligand Reports Fourth Quarter and Full Year 2016 Financial Results http://investor.ligand.com/news/detail/315/ligand-reports-fourth-quarter-and-full-year-2016-financial-results Thu, 23 Feb 2017 16:01:00 -0500 http://investor.ligand.com/news/detail/315/ligand-reports-fourth-quarter-and-full-year-2016-financial-results

Conference Call Begins at 4:30 p.m. Eastern Time Today

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today reported financial results for the three and 12 months ended December 31, 2016, and provided an operating forecast and program updates. Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time.

“2016 was an exceptional year for Ligand. We reported substantial revenue growing more than 50% over last year and strong operating cash flow. Evomela, a new commercial product with a high royalty rate to Ligand, launched and joined Promacta® and Kyprolis® as major drivers of royalty revenue. We also had a very successful year operating our OmniAb business following the acquisition of OMT approximately one year ago. Additionally, many new deals entered our portfolio and numerous late-stage partnered assets generated meaningful positive news,” said John Higgins, Chief Executive Officer. “2017 is positioned to be another year of strong growth in revenue and cash flow. We anticipate beginning to receive royalties from new product launches, and look forward to major data readouts from many late-stage partnered programs, results from our Phase 2 GRA trial and partners entering the clinic with antibodies from our OmniAb platform.”

Fourth Quarter 2016 Financial Results

Total revenues for the fourth quarter of 2016 were $38.2 million, compared with $21.2 million for the same period in 2015, an increase of 80%. Royalty revenues were $19.6 million, compared with $11.5 million for the same period in 2015 primarily due to higher royalties from Promacta and Kyprolis. Material sales were $9.1 million, compared with $7.2 million for the same period in 2015 due to timing of Captisol® purchases for use in clinical trials and commercial products. License and milestone revenues were $9.5 million, compared with $2.4 million for the same period in 2015 due to a higher number of contract payments and contributions from OmniAb-related deals.

Cost of goods sold was $2.9 million for the fourth quarter of 2016, compared with $0.9 million for the same period in 2015 due to the timing and mix of Captisol sales. Amortization of intangibles was $2.7 million, compared with $0.6 million for the same period in 2015 due primarily to additional amortization of intangibles related to the acquisition of OMT. Research and development expense was $6.4 million, compared with $2.3 million for the same period of 2015 as a result of the addition of OMT-related expenses, timing of spending on internal development programs and non-cash stock-based compensation expense. General and administrative expense was $6.6 million, compared with $6.2 million for the same period in 2015 due to costs associated with OMT and non-cash stock-based compensation expense.

GAAP net loss for the fourth quarter of 2016 was $3.1 million, or $0.15 per share, compared with GAAP net income for the fourth quarter of 2015 of $6.3 million, or $0.29 per diluted share. GAAP net income for the fourth quarter of 2016 was impacted by a $9.0 million non-cash charge related to Viking Therapeutics, primarily for a markdown of the book value of our holdings in Viking to current market values. Adjusted net income for the fourth quarter of 2016 was $16.1 million, or $0.74 per diluted share, compared with adjusted net income for the same period in 2015 of $12.2 million, or $0.59 per diluted share. Adjusted net income and EPS are now being reported on a fully-taxed basis, as disclosed in the Form 8-K filed with the Securities and Exchange Commission January 18, 2017. See “Adjusted Financial Measures” and the accompanying table below for the adjusted calculations and reconciliation to comparable GAAP financial measures.

As of December 31, 2016, Ligand had cash, cash equivalents and short-term investments of $141.0 million. Cash generated from operations was $21.0 million and $63.0 million for the 2016 fourth quarter and full year, respectively.

Full Year Financial Results

Total revenues in 2016 were $109.0 million, compared with $71.9 million for 2015, an increase of 52%. Royalty revenues were $59.4 million, compared with $38.2 million for 2015 primarily due to higher royalties from Promacta and Kyprolis. Material sales were $22.5 million, compared with $27.7 million for 2015 due to timing of Captisol purchases for use in clinical trials and commercial products. License and milestone revenues were $27.0 million, compared with $6.1 million for 2015 due to a higher number of contract payments and contributions from OmniAb-related deals.

Cost of goods sold was $5.6 million in 2016, compared with $5.8 million for 2015 due to the timing and mix of Captisol sales. Amortization of intangibles was $10.6 million, compared with $2.4 million for 2015 due primarily to additional amortization of intangibles related to the acquisition of OMT. Research and development expense was $21.2 million, compared with $11.0 million for 2015 as a result of the addition of OMT-related expenses, timing of spending on internal development programs and non-cash stock-based compensation expense. General and administrative expense was $26.6 million, compared with $24.4 million for 2015 due to costs associated with OMT and non-cash stock-based compensation expense.

GAAP net loss in 2016 was $1.6 million, or $0.08 per share, compared with GAAP net income in 2015 of $229.8 million, or $10.83 per diluted share. The difference is primarily attributable to a net income tax benefit in 2015 of $206.0 million, or $9.70 per diluted share, from the release of valuation allowance. 2016 GAAP net loss was also impacted by a $23.1 million non-cash charge associated with our investment in Viking, primarily consisting of a loss on dilution as a result of Viking financings and the mark-to-market charge taken in the fourth quarter of 2016. Adjusted net income for 2016 was $46.7 million, or $2.15 per diluted share, compared with adjusted net income in 2015 of $47.6 million, or $2.31 per diluted share.

2017 Financial Forecast

The Company expects 2017 revenues to consist of three components: royalties, material sales and contract (license and milestone) revenue. At this time, Ligand estimates 2017 core revenue to include royalties of approximately $87 million, material sales of approximately $23 million and contract payments of at least $20 million. During 2017, Ligand estimates it could potentially receive up to an additional $30 million of contract payments, however external events are out of Ligand’s control so the Company will provide more information about the timing and probability for any additional contract revenue expected to be booked in 2017 as the year progresses. Ligand estimates that cash expenses for 2017 will be in the range of $28 million to $30 million, consistent with the cash expenses incurred for 2016. Ligand notes that with core revenue of $130 million, adjusted earnings per diluted share would be approximately $2.70. This amount is expected to be higher in the event additional contract revenue is received in 2017. The core adjusted EPS figure reflects the Company’s new fully-taxed adjusted EPS methodology, including a 36% to 39% tax rate, but the Company continues to pay less than 1% cash taxes as it utilizes its over $500 million of remaining NOLs.

ASC 606 – Revenue Accounting Standard

In May 2014 the Financial Accounting Standards Board issued Accounting Standards Codification Topic 606 (ASC 606), Revenue From Contracts With Customers, which is intended to provide a single, comprehensive revenue recognition model for all contracts with customers and thereby improve comparability within industries, across industries, and across capital markets. Companies must implement this new standard no later than January 1, 2018 and they can elect to adopt the standard after January 1, 2017. At this time, Ligand does not expect to adopt ASC 606 as of January 1, 2017.

Fourth Quarter 2016 and Recent Business Highlights

Portfolio Program Progress

Promacta®/Revolade®

  • Novartis reported fourth quarter 2016 net sales of Promacta (eltrombopag) of $178 million, a $45 million or 34% increase over the same period in 2015.

Kyprolis® (carfilzomib), an Amgen Product Utilizing Captisol

  • On February 2, 2017, Amgen reported fourth quarter 2016 net sales of Kyprolis (carfilzomib) of $183 million, a $35 million or 24% increase over the same period in 2015.
  • On February 2, 2017, Ono Pharmaceutical reported that Kyprolis sales in Japan were ¥11 billion ($9.7 million) since the product was launched in August of 2016 through December 31, 2016.
  • 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.

Additional Pipeline and Partner Developments

  • Retrophin announced positive top-line results from the Phase 2 DUET study of sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS). 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. Additional data from the Phase 2 DUET study of sparsentan for the treatment of FSGS were presented at the late-breaking High-Impact Clinical Trials oral session at the American Society of Nephrology Kidney Week 2016. Retrophin also announced it would meet with the FDA in January 2017 regarding the regulatory pathway for sparsentan in FSGS.
  • Lundbeck announced FDA approval of Carnexiv™ (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Ligand earned a $1.25 million milestone payment upon approval and is entitled to receive a royalty of 2.75% on net sales of Carnexiv.
  • Sage Therapeutics announced an expedited development plan for brexanolone (SAGE-547) in the treatment of postpartum depression (PPD) following receipt of formal meeting minutes from a breakthrough therapy meeting with the FDA. Sage anticipates announcing top-line data from the PPD registration trials in 2H 2017.
  • Melinta Therapeutics announced that the NDAs for approval of IV and oral Baxdela™ (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) were accepted for filing by the FDA and were granted a PDUFA date of June 19, 2017. If approved, Ligand is entitled to receive a 2.5% royalty on net sales of the IV formulation of Baxdela and a $1.5 million approval milestone payment.
  • The FDA granted orphan designation to Merck’s Noxafil for treatment of invasive aspergillosis.
  • 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.
  • Eli Lilly presented data on Captisol-enabled prexasertib (LY2606368) demonstrating activity in patients with BRCA wild type sporadic high-grade serous ovarian cancer at the European Society for Medical Oncology 2016 Congress.
  • Viking Therapeutics announced it expects the Phase 2 clinical trial of VK5211 in patients recovering from hip fracture surgery and the Phase 2 clinical trial of VK2809 in patients with primary hypercholesterolemia and non-alcoholic fatty liver disease to be completed in the second quarter of 2017.
  • Viking Therapeutics announced positive initial results from a proof-of-concept study of VK2809 in an in vivo model of glycogen storage disease 1a (GSD 1a) and announced funding of initial clinical development of VK2809 for treatment of GSD 1a with plans to file and IND in the second half of 2017.
  • Aldeyra provided an update on its Phase 3 clinical program of ADX-102 in noninfectious anterior uveitis and anticipates beginning the Phase 3 trial in the second quarter of 2017.
  • Aldeyra announced that it had enrolled the first patient in a Phase 2b clinical trial of ADX-102 for the treatment of allergic conjunctivitis and also presented results of a Phase 2 clinical trial of ADX-102 topical ophthalmic solution in a challenge model of allergic conjunctivitis.
  • Merck KGaA announced it licensed rights to develop Captisol-enabled VX-970 from Vertex Pharmaceuticals. Economic terms of the original agreement between Ligand and Vertex remained unchanged.
  • Takeda presented clinical data on Captisol-enabled pevonedistat in older patients with acute myeloid leukemia at ASH 2016.
  • XTL Biopharmaceuticals announced the company intends to pursue Sjögren-Larsson Syndrome as the second indication for its lead drug candidate hCDR1.
  • Oncobiologics presented final data from the Phase 1 trial evaluating bioequivalence of ONS-3010 (Humira® biosimilar) and the U.S. and European originator versions of Humira (adalimumab).
  • Gilead Sciences highlighted Captisol-enabled GS-5734 for the treatment of Ebola virus infection at JP Morgan’s healthcare conference.

New Licensing Deals

  • Ligand announced a worldwide license agreement with Ono Pharmaceutical to use the OmniAb platform technologies to discover fully human antibodies. Ligand is eligible to receive annual access payments, milestone payments and royalties on future net sales of any antibodies discovered under these licenses.
  • Ligand announced global license and supply agreements with Novartis for the development and commercialization of a Captisol-enabled oral liquid formulation of trametinib, a kinase inhibitor currently indicated as a single agent or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation. Ligand will be eligible to receive royalties on future net sales and revenue from Captisol material sales. Novartis will be responsible for all costs related to the program.
  • Ligand entered into a Captisol Clinical Use/Supply Agreement with Eisai.

Internal Glucagon Receptor Antagonist (GRA) Program

  • Ligand announced its GRA program was featured in an article published in Nature Reviews Drug Discovery entitled Targeting hepatic glucose metabolism in the treatment of type 2 diabetes.

Adjusted Financial Measures

The Company reports adjusted results for diluted net income per share and net income, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company’s financial measures under GAAP include stock-based compensation expense, amortization of debt-related costs, amortization related to acquisitions, changes in contingent liabilities, net losses of Viking Therapeutics, mark-to-market adjustment for amounts owed to licensors, fair value adjustments to Viking Therapeutics convertible note receivable and warrants, unissued shares relating to the Senior Convertible Note, unissued shares relating to the anti-dilutive effect of fourth quarter and fiscal year 2016 GAAP net loss and adjustments for discontinued operations, and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included in this press release. However, other than with respect to total revenue, the Company only provides guidance on an adjusted basis and does not provide reconciliations of such forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in contingent liabilities, net losses of Viking Therapeutics, mark-to-market adjustments for amounts owed to licensors and fair value adjustments to Viking Therapeutics convertible note receivable. Management has excluded the effects of these items in its adjusted measures to assist investors in analyzing and assessing the Company’s past and future core operating performance. Additionally, adjusted diluted earnings per share is a key component of the financial metrics utilized by the Company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

Conference Call

Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (877) 407-4019 from the U.S. or (201) 689-8337 from outside the U.S., using the passcode “Ligand.” To participate via live or replay webcast, a link will be available at www.ligand.com.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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 affairs and commercialization) to ultimately generate our revenue. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono- and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding: Ligand’s future revenue growth, including the timing, mix and volume of Captisol orders, the timing of the initiation or completion of clinical trials by Ligand and its partners, the timing of new product launches by Ligand and its partners and the related royalties Ligand expects to receive from its partners, the timing of review of clinical data by the FDA, expected value creation for shareholders and guidance regarding the full-year 2017 financial results. Actual events or results may differ from Ligand's expectations. For example, Ligand may not receive expected revenue from material sales of Captisol, expected royalties on other partnered products and research or development milestone payments. Ligand and its partners may not be able to timely or successfully advance any product(s) in its internal or partnered pipeline. In addition, there can be no assurance that Ligand will achieve its guidance for 2017 or any portion thereof or beyond, that Ligand's 2017 revenues will be at the levels as currently anticipated, that Ligand will be able to create future revenues and cash flows by developing innovative therapeutics, that results of any clinical study will be timely, favorable or confirmed by later studies, that products under development by Ligand or its partners will receive regulatory approval, that there will be a market for the product(s) if successfully developed and approved, or that Ligand's partners will not terminate any of its agreements or development or commercialization of any of its products. Further, Ligand may not generate expected revenues under its existing license agreements and may experience significant costs as the result of potential delays under its supply agreements. Also, Ligand and its partners may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result in increased costs and delays, or limit Ligand's ability to obtain regulatory approval. Further, unexpected adverse side effects or inadequate therapeutic efficacy of Ligand's product(s) could delay or prevent regulatory approval or commercialization. In addition, Ligand may not be able to successfully implement its strategic growth plan and continue the development of its proprietary programs. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Other Disclaimers and Trademarks

The information in this press release regarding certain third-party products and programs, including Promacta, a Novartis product, and Kyprolis, an Amgen product, comes from information publicly released by the owners of such products and programs. Ligand is not responsible for, and has no role in, the development of such products or programs.

Ligand owns or has rights to trademarks and copyrights that it uses in connection with the operation of its business including its corporate name, logos and websites. Other trademarks and copyrights appearing in this press release are the property of their respective owners. The trademarks Ligand owns include Ligand®, Captisol® and OmniAb®. Solely for convenience, some of the trademarks and copyrights referred to in this press release are listed without the ®, © and TM symbols, but Ligand will assert, to the fullest extent under applicable law, its rights to its trademarks and copyrights.

LIGAND PHARMACEUTICALS, INCORPORATED

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in thousands, excluding per-share data)

 
Three Months Ended December 31, Year Ended December 31,
2016   2015 2016   2015
Revenues:
Royalties $ 19,581 $ 11,546 $ 59,423 $ 38,194
Material sales 9,056 7,206 22,502 27,662
License fees, milestones and other revenues 9,548   2,440   27,048   6,058  
Total revenues 38,185 21,192 108,973 71,914
Operating costs and expenses:
Cost of goods sold 2,896 884 5,571 5,807
Amortization of intangibles 2,731 594 10,643 2,375
Research and development 6,408 2,276 21,221 11,005
General and administrative 6,626 6,190 26,621 24,378
Non-continuing expenses 169   234   1,032   1,020  
Total operating costs and expenses 18,830   10,178   65,088   44,585  
Income from operations 19,355 11,014 43,885 27,329
Other expense, net (2,393 ) (3,049 ) (9,459 ) (10,034 )
Increase in contingent liabilities (738 ) (37 ) (3,334 ) (5,013 )
Gain on deconsolidation of Viking 28,190
Loss from Viking (8,994 ) (2,102 ) (23,132 ) (5,143 )
Total other expense, net (12,125 ) (5,188 ) (35,925 ) 8,000  
Income before income taxes 7,230 5,826 7,960 35,329
Income tax (expense) benefit (10,355 ) 515   (10,327 ) 192,115  
(Loss) income from continuing operations including noncontrolling interests $ (3,125 ) $ 6,341   $ (2,367 ) $ 227,444  
 
Discontinued operations:
Gain on sale of Oncology Product Line, net of tax     731    
Net (loss) income: (3,125 ) 6,341   (1,636 ) 227,444  
Less: net loss attributable to noncontrolling interests (2,380 )
Net (loss) income attributable to common shareholders $ (3,125 ) $ 6,341   $ (1,636 ) $ 229,824  
 
Basic per-share amounts:
(Loss) income from continuing operations $ (0.15 ) $ 0.32 $ (0.11 ) $ 11.61
Discontinued operations     0.04    
Net (loss) income $ (0.15 ) $ 0.32   $ (0.08 ) $ 11.61  
Diluted per-share amounts:
(Loss) income from continuing operations $ (0.15 ) $ 0.29 $ (0.11 ) $ 10.83
Discontinued operations     0.04    
Net (loss) income $ (0.15 ) $ 0.29   $ (0.08 ) $ 10.83  
 
Weighted average number of common shares-basic 20,898,453 19,932,908 20,831,454 19,789,991
Weighted average number of common shares-diluted 20,898,453 21,541,821 20,831,454 21,227,887
 

LIGAND PHARMACEUTICALS, INCORPORATED

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited, in thousands)

 
December 31, 2016 December 31, 2015
Assets
Current assets:
Cash, cash equivalents and short-term investments $ 141,048 $ 200,219
Accounts receivable, net 14,700 6,170
Note receivable 3,207 4,782
Inventory 1,923 1,633
Other current assets 2,175   1,908
Total current assets 163,053 214,712
 
Deferred income taxes 123,891 189,083
Goodwill and other identifiable intangible assets 276,912 60,585
Investment in Viking 8,345 29,728
Commercial license rights 25,821 8,554
Property and equipment, net 1,819 372
Other assets 1,744   27
Total assets $ 601,585   $ 503,061
 
Liabilities and Stockholders' Equity
Current contingent liabilities $ 5,088 $ 10,414
Accounts payable and accrued liabilities 9,131 10,422
Short-term debt 212,910   201,985
Total current liabilities 227,129 222,821
 
Long-term debt
Long-term portion of contingent liabilities 2,916 3,033
Other long-term liabilities 687   297
Total liabilities 230,732 226,151
Equity component of currently redeemable convertible notes 29,563   39,628
Total Ligand Pharmaceuticals stockholders' equity 341,290   237,282
Total liabilities and stockholders' equity $ 601,585   $ 503,061
 

LIGAND PHARMACEUTICALS INCORPORATED

ADJUSTED FINANCIAL MEASURES

(Unaudited, in thousands, excluding per-share data)

 

Three months ended
December 31,

 

Year ended
December 31,

2016   2015 2016   2015
 
 
Net income $ (3,125 ) $ 6,341 $ (1,636 ) $ 229,824
Stock-based compensation expense 5,204 2,947 18,893 12,458
Non-cash interest expense(1) 2,795 2,628 10,926 10,274
Amortization related to acquisitions 2,895 638 11,072 2,419
Loss from Viking(2) 8,994 2,102 23,132 5,143
Increase in contingent liabilities(3) 738 37 3,334 5,013
Fair market value adjustment on Viking note and warrants(4) 765 (462 ) 765
Mark-to-market adjustment for investments owed to licensors(5) (68 ) (40 ) (36 ) 531
Income tax effect of adjusted reconciling items above(6) (7,295 ) (3,174 ) (23,726 ) (12,800 )
Deferred tax asset valuation allowance(7) 5,939 5,939 (205,996 )
Discontinued operations, net of tax     (731 )  
Adjusted net income from continuing operations $ 16,077   $ 12,244   $ 46,705   $ 47,631  
Diluted per-share amounts attributable to common shareholders:
Net income $ (0.15 ) $ 0.29 $ (0.08 ) $ 10.83
Stock-based compensation expense 0.25 0.14 0.91 0.59
Non-cash interest expense(1) 0.13 0.12 0.52 0.48
Amortization related to acquisitions 0.14 0.03 0.53 0.11
Loss from Viking(2) 0.43 0.10 1.11 0.24
Increase in contingent liabilities(3) 0.04 0.16 0.24
Fair market value adjustment on Viking note and warrants(4) 0.04 (0.02 ) 0.04
Mark-to-market adjustment for investments owed to licensors(5) 0.03
Income tax effect of adjusted reconciling items above(6) (0.35 ) (0.15 ) (1.14 ) (0.60 )
Deferred tax asset valuation allowance(7) 0.28 0.29 (9.70 )
Discontinued operations, net of tax (0.04 )
2019 Senior Convertible Notes share count adjustment (0.03 ) 0.02   (0.09 ) 0.05  
Adjusted net income from continuing operations $ 0.74   $ 0.59   $ 2.15   $ 2.31  
 
Weighted average shares used in calculation of GAAP diluted earnings per share 20,898 21,542 20,831 21,228
Shares excluded due to anti-dilutive effect on GAAP net loss 1,728 1,884
Weighted average dilutive potential common shares issuable of 2019 Senior Convertible Notes (843 ) (789 ) (995 ) (499 )
Weighted average shares used in calculation of adjusted diluted earnings per share 21,783 20,753 21,720 20,729

(1) Non-cash debt related costs is calculated in accordance with the authoritative accounting guidance for convertible debt instruments that may be settled in cash.

(2) Loss from Viking reflects the Company's share of Viking's net loss of $1.2 million and $5.1 million for the three and twelve months ended December 31, 2016 respectively, and the decrease in the book value of the Company's equity method investment in Viking of $0.3 million and $10.6 million for the three and twelve months ended December 31, 2016, respectively, as a result of the Company's decreased ownership percentage in Viking after Viking's financing and an in impairment charge of $7.4 million for the year ended December 31, 2016 as a result of an other than temporary decrease in the value of our investment in Viking.

The $28.2 million gain on deconsolidation of Viking in 2015 is not reflected above as an adjustment to GAAP results as the $28.2 million gain comprises primarily $29.2 million in consideration we received from a licensing arrangement, which we consider to be recurring in nature and core to our operations. The $29.2 million payment consists of the license fee, in the form of Viking common stock, we received under the Master Licensing Agreement (“MLA”) entered into between the Company and Viking in May of 2014 whereby the Company granted Viking rights to five programs. Pursuant to the MLA, as partial consideration for the grant of the rights and licenses under the MLA, upon the consummation of an initial public offering (“IPO”), Viking was required to issue to the Company shares of Viking common stock. In May 2015, Viking completed its IPO, at which time the Company received approximately 3.7 million shares of Viking common stock.

(3) Changes in fair value of contingent consideration related to CyDex and Metabasis transactions.

(4) Changes in fair value of Viking Therapeutics, Inc. note receivable and warrants.

(5) Amounts due to Bristol-Myers Squibb relating to the agreement with Retrophin.

(6) Prior to the quarter ended December 31, 2016, adjustments to GAAP included a separate income tax expense adjustment from GAAP tax expense to the amount of cash taxes paid or payable for the respective period. As of December 31, 2016, the presentation includes the tax effect of the adjustments to GAAP as prescribed by the updated Compliance and Disclosure Interpretations issued by the SEC in May, 2016. In the three months ended December 31, 2016 and 2015, cash taxes paid were $2 thousand and $9 thousand, respectively. A reconciliation to the previously reported adjusted results is presented below.

(7) Deferred tax asset valuation allowance for the three and twelve months ended December 31, 2016 relates to a valuation allowance placed on the deferred tax asset associated with Viking losses including the other than temporary impairment charge of $7.4 million. Deferred tax asset valuation allowance for the twelve months ended December 31, 2015 primarily relates to the release of previously reserved net operating losses and credits.

         

Three months ended
December 31,

 

Year ended
December 31,

2016 2015 2016 2015
Adjusted net income from continuing operations - as revised (see above) $ 16,077 $ 12,244 $ 46,705 $ 47,631
Amortization of CyDex acquired intangible assets (618 ) (638 ) (2,450 ) (2,419 )
Income tax effect of the reconciling items (see above) 7,295 3,174 23,726 12,800
Deferred tax asset valuation allowance (5,939 ) (5,939 )
Non-cash income taxes (as previously reported) 10,355   (523 ) 10,327   13,592  
Adjusted net income from continuing operations (as previously reported) $ 27,170   $ 14,257   $ 72,369   $ 71,604  
 
Adjusted EPS from continuing operations as previously reported $ 1.25 $ 0.69 $ 3.33 $ 3.45

Note: Adjusted net income per share basic and diluted as presented above were also revised as a result of the changes to the income tax effect of the adjustments to GAAP as noted above

Ligand Pharmaceuticals Incorporated
Todd Pettingill, (858) 550-7500
investors@ligand.com
Twitter: @Ligand_LGND
or
LHA
Bruce Voss, (310) 691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

]]>
Dr. Christel Iffland Joins Ligand as Vice President, Antibody Technologies, Expands Team Focused on OmniAb Drug Discovery Platform http://investor.ligand.com/news/detail/314/dr-christel-iffland-joins-ligand-as-vice-president-antibody-technologies-expands-team-focused-on-omniab-drug-discovery-platform Tue, 14 Feb 2017 16:30:00 -0500 http://investor.ligand.com/news/detail/314/dr-christel-iffland-joins-ligand-as-vice-president-antibody-technologies-expands-team-focused-on-omniab-drug-discovery-platform

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces the appointment of Christel Iffland, Ph.D. as a Vice President of Antibody Technologies.

Dr. Iffland joins Ligand from Merck KGaA/EMD Serono where she served as Group Leader of Antibody Display Technologies, a Senior Scientist of Phage Technologies and Structural Biology and Associate Director of Antibody Technologies. At Ligand, Dr. Iffland will support current and new partnerships and collaborations for the OmniAb franchise, providing scientific guidance and input. Additionally, she will contribute to the continued growth and next-generation innovation of OmniAb and to the technical assessment of new opportunities.

“Christel has been a longtime user of the OmniAb technology and we are delighted to welcome her to Ligand as we further expand our scientific team focused on antibodies and antibody technologies,” said John Higgins, Ligand’s Chief Executive Officer. “Our acquisition of the OmniAb technology last year transformed and expanded Ligand’s business model. Antibody treatments are the fastest-growing segment of the pharmaceutical industry and will continue to be an important area of focus for Ligand as we expand our portfolio of more than 150 fully-funded shots-on-goal.”

Dr. Iffland received her Ph.D. in Molecular and Cell Biology from the Université de Nice Sophia-Antipolis in Nice, France and completed post-doctoral research training at both the Dana-Farber Cancer Institute at Harvard Medical School and the Albert Einstein College of Medicine. Dr. Iffland is an author of numerous scientific publications and patents and is a prior recipient of the Merck Award for Patent and Inventorship.

About OmniAb®

OmniAb includes three transgenic animal platforms for producing mono- and bispecific human therapeutic antibodies. OmniRat® is the industry’s first human monoclonal antibody technology based on rats. It has a complete immune system with a diverse antibody repertoire and generates antibodies with human idiotypes as effectively as wild-type animals make rat antibodies. OmniMouse® is a transgenic mouse that complements OmniRat and expands epitope coverage. OmniFlic® is an engineered rat with a fixed light chain for development of bispecific, fully human antibodies. The three platforms use patented technology, have broad freedom to operate and deliver fully human antibodies with high affinity, specificity, expression, solubility and stability.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Actual events or results may differ from our expectations. For example, there can be no assurances that Ligand will be able to develop a next-generation OmniAb technology or that the antibody treatments will continue to be the fastest-growing segment of the pharmaceutical industry. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other important risk factors affecting Ligand can be found in Ligand's prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission, available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Ligand Pharmaceuticals Incorporated
Todd Pettingill, (858) 550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Bruce Voss, (310) 691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

]]>
Reminder: Ligand to Host Analyst Day on February 28th in New York City http://investor.ligand.com/news/detail/313/reminder-ligand-to-host-analyst-day-on-february-28th-in-new-york-city Mon, 13 Feb 2017 16:30:00 -0500 http://investor.ligand.com/news/detail/313/reminder-ligand-to-host-analyst-day-on-february-28th-in-new-york-city

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) will host an Analyst Day on Tuesday, February 28, 2017 from 10:00 a.m. to 11:30 a.m. Eastern time (7:00 a.m. to 8:30 a.m. Pacific time) in New York City at the Andaz 5th Avenue, 485 5th Avenue at East 41st Street.

Presenters will include:

  • John Higgins, Chief Executive Officer
  • Matt Foehr, President and Chief Operating Officer
  • Matt Korenberg, Chief Financial Officer
  • Roland Buelow, Ph.D., Vice President, Antibody Technologies
  • Eric Vajda, Ph.D., Vice President, Preclinical Research and Development

Presentations will cover the following topics:

  • Update on Ligand’s business model and financials, expanded portfolio, technology platforms and intellectual property
  • Overview of partner and license portfolio and highlights of Big 6 and Next 12 programs
  • Research investment priorities
  • Outlook for OmniAb antibody discovery business and a review of the OMT acquisition one year following the deal
  • Update on Glucagon Receptor Antagonist (GRA) development program for Type 2 diabetes
  • Details of 2017 financial outlook

The event will be webcast live and will be available at www.ligand.com. A replay of the webcast will be available for 90 days following the event. The presentation will be followed by a luncheon reception for those attending in person. For more information or to reserve a seat, please contact Ani Mikaelian at amikaelian@lhai.com.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Ligand Pharmaceuticals Incorporated
Todd Pettingill, (858) 550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Bruce Voss, (310) 691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

]]>
Ligand to Host Analyst Day on February 28th in New York City http://investor.ligand.com/news/detail/312/ligand-to-host-analyst-day-on-february-28th-in-new-york-city Tue, 24 Jan 2017 16:30:00 -0500 http://investor.ligand.com/news/detail/312/ligand-to-host-analyst-day-on-february-28th-in-new-york-city

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) will host an Analyst Day on Tuesday, February 28, 2017 from 10:00 a.m. to 11:30 a.m. Eastern time (7:00 a.m. to 8:30 a.m. Pacific time) in New York City.

Company presenters will include:

  • John Higgins, Chief Executive Officer
  • Matt Foehr, President and Chief Operating Officer
  • Matt Korenberg, Chief Financial Officer
  • Roland Buelow, Ph.D., Vice President, Antibody Technologies

The event will be webcast live and will be able to be accessed at www.ligand.com. A replay of this webcast will be available for 90 days following the event. For more information or to reserve a seat, please contact Ani Mikaelian at amikaelian@lhai.com.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono- and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Ligand Pharmaceuticals Incorporated
Todd Pettingill
(858) 550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Bruce Voss
(310) 691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

]]>
Ligand to Report Fourth Quarter and Full Year 2016 Results on February 23rd http://investor.ligand.com/news/detail/311/ligand-to-report-fourth-quarter-and-full-year-2016-results-on-february-23rd Mon, 23 Jan 2017 16:30:00 -0500 http://investor.ligand.com/news/detail/311/ligand-to-report-fourth-quarter-and-full-year-2016-results-on-february-23rd

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today plans to report fourth quarter and full year 2016 financial results on February 23, 2017. Ligand’s CEO John Higgins, President and COO Matt Foehr and CFO Matt Korenberg will host the conference call.

Fourth Quarter and Full Year 2016 Earnings Call

   
What: Ligand conference call to discuss financial results and provide general business updates
 
When: Thursday, February 23, 2017
 
Time: 4:30 p.m. Eastern time (1:30 p.m. Pacific time)
 
Conference Call:

(877) 407-4019 within the U.S.

(201) 689-8337 outside the U.S.
Passcode: Ligand
 
Webcast:

Live conference call webcast and replay accessible at www.ligand.com

 

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono- and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Ligand Pharmaceuticals Incorporated
Todd Pettingill, 858-550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Bruce Voss, 310-691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

]]>
Ligand Enters Commercial License and Supply Agreements for Captisol®-enabled trametinib http://investor.ligand.com/news/detail/310/ligand-enters-commercial-license-and-supply-agreements-for-captisol-enabled-trametinib Thu, 22 Dec 2016 09:15:00 -0500 http://investor.ligand.com/news/detail/310/ligand-enters-commercial-license-and-supply-agreements-for-captisol-enabled-trametinib

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces it has entered into global license and supply agreements with Novartis for the development and commercialization of a Captisol-enabled oral liquid formulation of trametinib, a kinase inhibitor currently indicated as a single agent or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation. Under the terms of the license, Ligand will be eligible to receive a license fee, royalties on future net sales, and revenue from Captisol material sales. Novartis will be responsible for all costs related to the program.

“This represents an expansion of our relationship with Novartis as they develop an oral liquid formulation potential treatment option,” commented John Higgins, Chief Executive Officer of Ligand. “This transaction continues to show the ability of Captisol to address unmet solubility and other formulation issues facing the industry.”

About Captisol®

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including Amgen’s Kyprolis®, Baxter International’s Nexterone® and Spectrum’s EVOMELA®. There are more than 40 Captisol-enabled products currently in various stages of development.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These include statements regarding clinical development of Captisol-enabled trametinib, the possibility of regulatory approval for a pediatric indication, commercial success, efficacy, potency, competitiveness and the strength of Ligand's product portfolio. Actual events or results may differ from our expectations. For example, there can be no assurance that Captisol-enabled trametinib will progress through clinical development or receive required regulatory approvals within the expected timelines or at all, that further clinical trials will confirm any safety or other characteristics or profile, that there will be a market of any size for Captisol-enabled trametinib or that Captisol-enabled trametinib will be beneficial to patients or successfully marketed. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other important risk factors affecting Ligand can be found in Ligand's prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission, available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Ligand Pharmaceuticals Incorporated
Todd Pettingill, 858-550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Bruce Voss, 310-691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

]]>
Ligand Enters into Worldwide OmniAb® Platform License Agreement with ONO PHARMACEUTICAL CO., LTD. http://investor.ligand.com/news/detail/309/ligand-enters-into-worldwide-omniab-platform-license-agreement-with-ono-pharmaceutical-co-ltd Thu, 22 Dec 2016 08:30:00 -0500 http://investor.ligand.com/news/detail/309/ligand-enters-into-worldwide-omniab-platform-license-agreement-with-ono-pharmaceutical-co-ltd

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces it has entered into a worldwide license agreement with ONO PHARMACEUTICAL CO., LTD. (TSE: 4528). Under the license, ONO will be able to use the OmniRat®, OmniMouse® and OmniFlic® platforms to discover fully human mono- and bispecific antibodies. Ligand is eligible to receive annual platform access payments, development milestone payments and royalties for each product incorporating an OmniAb antibody. ONO will be responsible for all costs related to the programs.

“Gaining access to the OmniAb platform provides ONO with an industry-leading novel technology for the discovery of antibody therapeutics,” said John Higgins, Chief Executive Officer of Ligand. “This agreement continues to demonstrate the demand of companies with rich R&D histories to use OmniAb in their search for novel antibody therapeutics and further expands the global diversity of our OmniAb partners.”

“Following the development of human anti PD-1 monoclonal antibody OPDIVO®, we will continue to provide hope to sufferers of various diseases,” said Hiromu Habashita, Corporate Officer, and Executive Director of Discovery & Research. “The access to OmniAb® platforms is expected to dramatically improve our discovery research in novel antibody therapeutics.”

About OmniAb®

OmniAb includes three transgenic animal platforms for producing mono- and bispecific human therapeutic antibodies. OmniRat® is the industry’s first human monoclonal antibody technology based on rats. It has a complete immune system with a diverse antibody repertoire and generates antibodies with human idiotypes as effectively as wild-type animals make rat antibodies. OmniMouse® is a transgenic mouse that complements OmniRat and expands epitope coverage. OmniFlic® is an engineered rat with a fixed light chain for development of bispecific, fully human antibodies. The three platforms use patented technology, have broad freedom to operate and deliver fully human antibodies with high affinity, specificity, expression, solubility and stability.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono- and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies, including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

About ONO PHARMACEUTICAL CO., LTD.

ONO PHARMACEUTICAL CO., LTD., headquartered in Osaka, Japan, is an R&D-oriented pharmaceutical company committed to create innovative medicines in specific areas. It focuses especially on the oncology and diabetes areas. For more information, please visit the company’s website at http://www.ono.co.jp/eng/index.html.

Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These include statements regarding Ligand's license agreement with ONO under which Ligand may receive annual platform access payments, milestone payments and royalties (which, as used herein includes royalty-like payments based upon the development and commercialization of any products based on antibodies discovered under the license). Actual events or results may differ from our expectations. For example, there can be no assurances that ONO will successfully develop or market any antibodies discovered under the license. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other important risk factors affecting Ligand can be found in Ligand's prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission, available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Ligand Pharmaceuticals Incorporated
Todd Pettingill, (858) 550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Bruce Voss, (310) 691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

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Ligand Partner Retrophin Reports Additional Positive Data from Phase 2 DUET Study of Sparsentan in Focal Segmental Glomerulosclerosis at ASN Kidney Week 2016 http://investor.ligand.com/news/detail/308/ligand-partner-retrophin-reports-additional-positive-data-from-phase-2-duet-study-of-sparsentan-in-focal-segmental-glomerulosclerosis-at-asn-kidney-week-2016 Mon, 21 Nov 2016 07:30:00 -0500 http://investor.ligand.com/news/detail/308/ligand-partner-retrophin-reports-additional-positive-data-from-phase-2-duet-study-of-sparsentan-in-focal-segmental-glomerulosclerosis-at-asn-kidney-week-2016

Significant reduction of proteinuria compared to irbesartan

Statistically significant difference in modified partial remission; complete remission also observed

Further analysis supports sparsentan generally safe and well-tolerated

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) partner Retrophin, Inc. today announced additional results from the Phase 2 DUET study of sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS), a rare kidney disorder without an FDA-approved pharmacologic treatment that often leads to end-stage renal disease. These new findings are being presented today in the late-breaking High-Impact Clinical Trials oral session at the American Society of Nephrology (ASN) Kidney Week 2016 in Chicago.

“The prevalence of FSGS is on the rise and without an approved therapy, many patients diagnosed with the disorder face a progressive decline and the high likelihood of end-stage renal disease,” said Howard Trachtman, MD, Professor of Pediatrics; Director, Division of Pediatric Nephrology, NYU School of Medicine, NYU Langone Medical Center. “These findings from the DUET study underscore the potential of sparsentan as a first-in-class treatment for FSGS.”

As announced in September, top-line data from DUET showed the sparsentan treatment group achieved statistical significance in the study’s primary efficacy endpoint, reduction of proteinuria. These results showed a greater than two-fold reduction of proteinuria compared to irbesartan, after an eight-week, double-blind treatment period.

An analysis of the secondary endpoint presented today showed that a significantly greater proportion of patients receiving sparsentan achieved modified partial remission of proteinuria, compared to irbesartan-treated patients. Modified partial remission, defined as proteinuria levels of less than or equal to 1.5 g/g and greater than 40 percent reduction of proteinuria from baseline, is associated with long-term preservation of renal function in FSGS. In addition, four patients receiving sparsentan achieved complete remission, compared to zero irbesartan-treated patients. Also presented today was a post-hoc, intention-to-treat (ITT) analysis showing that the sparsentan treatment group again demonstrated a greater than two-fold reduction of proteinuria, compared to irbesartan. Further analysis of the safety database from the initial eight-week, double-blind treatment period presented today showed sparsentan was generally safe and well-tolerated.

“These new results add to the growing body of evidence from the DUET study, reinforcing our confidence that sparsentan may represent a significant advancement in the treatment of FSGS,” said Stephen Aselage, chief executive officer of Retrophin. “We thank the DUET investigators for their diligence, as well as the patients and their families for their commitment to finding new and better treatment options for FSGS.”

New findings from the DUET study presented at ASN Kidney Week include:

  • An analysis of the secondary endpoint, which showed that after the eight-week, double-blind treatment period, 28.1 percent of patients receiving sparsentan (n=64) achieved modified partial remission of proteinuria, compared to 9.4 percent of irbesartan-treated patients (n=32, p=0.040).
  • The proportion of patients achieving modified partial remission increased during the open label period. After 48 weeks of treatment with sparsentan (n=26), 57.7 percent of patients achieved modified partial remission. In addition, 50.0 percent of patients that transferred from irbesartan to sparsentan at the beginning of the open label period achieved modified partial remission after 40 weeks of treatment (n=12).
  • Complete remission, defined as proteinuria less than 0.3 g/g, was achieved by four patients receiving sparsentan during the eight-week, double-blind treatment period, compared to zero irbesartan-treated patients.
  • A post-hoc ITT analysis (imputing zero change in proteinuria for the 13 patients missing baseline or week 8 data) showed a statistically significant difference in the mean reduction of proteinuria from baseline for the sparsentan treatment group (n=73), compared to the irbesartan group (n=36), after the study’s eight-week, double-blind treatment period. The sparsentan group achieved a 42.7 percent mean reduction of proteinuria compared to 15.7 percent for the irbesartan group (p=0.004).
  • The ITT analysis also showed that after eight weeks of treatment with 400 mg and 800 mg of sparsentan (n=60), the mean reduction of proteinuria from baseline was 44.8 percent, compared to 15.9 percent for the irbesartan-treated patients in these two cohorts (n=28, p=0.008).
  • During the eight-week, double-blind period, the incidence of treatment-emergent adverse events (TEAE) for the sparsentan group was similar to the irbesartan group, except for edema. The severity of edema did not significantly worsen from baseline and no patients withdrew from the study as a result of edema during the eight-week, double-blind treatment period. The most common TEAEs in the study were headache, hypotension, dizziness, edema, nausea, diarrhea, vomiting and upper abdominal pain. The incidence of serious adverse events was similar across both groups.
  • 84 percent of patients who completed the eight-week, double blind treatment period continue to receive sparsentan in the open-label extension.

About the DUET Study

The DUET study is an international, randomized, double-blind, Phase 2 clinical trial assessing the safety and efficacy of sparsentan in 109 patients with primary focal segmental glomerulosclerosis (FSGS), of which 96 qualified for the evaluable efficacy database. The primary endpoint is the reduction of proteinuria, as compared to irbesartan, which is part of a class of drugs used to manage FSGS in the absence of an FDA-approved pharmacologic treatment. After a two-week washout period, patients were randomized to receive daily oral doses of 200 mg, 400 mg, and 800 mg of sparsentan or 300 mg of irbesartan. After completing an initial eight weeks of randomized treatment, all patients were eligible to receive sparsentan as part of the study’s open-label extension.

About Focal Segmental Glomerulosclerosis (FSGS)

Focal segmental glomerulosclerosis, or FSGS, is a rare disorder without an FDA-approved pharmacologic treatment option that is estimated to affect up to 40,000 patients in the U.S. with similar prevalence in Europe. The disorder is defined by progressive scarring of the kidney and often leads to end-stage renal disease. FSGS is characterized by proteinuria, where protein is found in the urine due to a breakdown of the normal filtration mechanism in the kidney. Other common symptoms include swelling in parts of the body known as edema, as well as low blood albumin levels, abnormal lipid profiles, and hypertension.

Reduction in proteinuria is widely regarded to be beneficial in the treatment of FSGS, and may be associated with a decreased risk of progression to end-stage renal disease. Achieving modified partial remission of proteinuria, defined as proteinuria levels of less than or equal to 1.5 g/g and greater than 40 percent reduction of proteinuria from baseline, is associated with long-term preservation of renal function in patients with FSGS. In the absence of an FDA-approved pharmacologic treatment, patients with FSGS are currently managed with angiotensin receptor blockers, angiotensin converting enzyme inhibitors, calcineurin inhibitors, and steroids.

About Sparsentan

Sparsentan could be the first FDA-approved pharmacologic treatment for focal segmental glomerulosclerosis, or FSGS, a rare kidney disorder that often leads to end-stage renal disease. Sparsentan’s dual mechanism of action combines angiotensin receptor blockade with endothelin receptor type A blockade. In several forms of chronic kidney disease, endothelin receptor blockade has been shown to have an additive beneficial effect on proteinuria in combination with renin-angiotensin blockade via angiotensin receptor blockade or angiotensin converting enzyme inhibitors.

The Phase 2 DUET study of sparsentan met the primary efficacy endpoint for the combined treatment group, demonstrating a greater than two-fold reduction of proteinuria compared to irbesartan, after the eight-week, double-blind treatment period. Retrophin is working with the FDA to determine the most expeditious path forward to advance the development of sparsentan towards approval. In 2015, the FDA and European Commission each granted sparsentan orphan drug designation for the treatment of FSGS.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These include statements regarding the possible use of sparsentan as a treatment options for FSGS, the timing and results of review by the Food and Drug Administration (FDA) of sparsentan, Retrophin’s plans to present the DUET study results at an upcoming medical meeting or in a peer-reviewed publication, and the ability of patients to continue in an open-label study of sparsentan. Actual events or results may differ from our expectations. For example, Ligand has no control whether Retrophin terminates the open-label study of sparsentan, including due to adverse events reported by patients, there can be no assurance that success in a Phase 2 clinical trial will result in success in future clinical trials; the safety and tolerability data from a new clinical trial in sparsentan may conflict with the results of the Phase 2 DUET clinical trial; and the number of patients diagnoses with FSGS may be more or fewer than Retrophin believes. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other important risk factors affecting Ligand can be found in Ligand's prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission, available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Ligand Pharmaceuticals Incorporated
Todd Pettingill, 858-550-7500
investors@ligand.com
Twitter: @Ligand_LGND
or
LHA
Bruce Voss, 310-691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

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Ligand Reports Third Quarter 2016 Financial Results http://investor.ligand.com/news/detail/307/ligand-reports-third-quarter-2016-financial-results Thu, 03 Nov 2016 16:01:00 -0400 http://investor.ligand.com/news/detail/307/ligand-reports-third-quarter-2016-financial-results

Conference Call Begins at 4:30 p.m. Eastern Time Today

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today reported financial results for the three and nine months ended September 30, 2016, and provided an operating forecast and program updates. Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time to discuss this announcement and answer questions.

“Our solid third quarter financial performance is highlighted by all-time high royalty revenues. In addition, we had a very active quarter with new licensings further increasing our portfolio of partnered assets,” said John Higgins, Chief Executive Officer of Ligand. “Novartis continues to make excellent progress with growing sales, expanding indications and entering new geographies with Promacta®. Amgen is focused on growing Kyprolis®, and Spectrum’s product Evomela® is showing good momentum in sales growth following its launch earlier this year. Also, recent positive clinical and regulatory milestones were achieved with a few of our more important portfolio programs, notably for programs or technologies licensed to Retrophin, Lundbeck and Melinta. We also initiated a Phase 2 clinical trial with LGD-6972 for the treatment of type 2 diabetes mellitus.”

Ligand is in the process of evaluating certain deferred tax assets (DTA) recorded in the third quarter of 2015. Ligand is reviewing the amount of net operating loss carryforwards recorded as a result of capitalized R&D expenses associated with two acquisitions accounted for in 2010. As a result, the amount of DTA Ligand recorded in connection with the release of its valuation allowance could be reduced by approximately 10% of the $217 million DTA booked in the third quarter of 2015. The impact of the reduction would reduce the one-time DTA gain and would reduce GAAP net income for that period by the same amount. The balance sheet for the third quarter of 2015 and every subsequent period would reflect the reduction in DTA. The 2015 GAAP net income and earnings per share, which would be impacted by the reduction in DTA, are not available at this time, but will be reported in Ligand’s Form 10-Q for the third quarter of 2016, which will include Ligand’s conclusion regarding the reduction in DTA. The GAAP and adjusted net income and EPS figures for the three and nine month periods ended September 30, 2016 would be unaffected by the changes.

Third Quarter 2016 Financial Results

Total revenues for the third quarter of 2016 were $21.6 million, compared with $17.7 million for the same period in 2015. Royalty revenues were $15.7 million, compared with $9.8 million for the same period in 2015 primarily due to higher royalties from Promacta® and Kyprolis®. Material sales were $4.2 million, compared with $6.0 million for the same period in 2015 due to timing of Captisol® purchases for use in clinical trials and commercial products. License and milestone revenues were $1.7 million, compared with $1.9 million for the same period in 2015.

Cost of goods sold was $1.0 million for the third quarter of 2016, compared with $1.3 million for the same period in 2015 due to the timing and mix of Captisol sales. Amortization of intangibles was $2.7 million, compared with $0.6 million for the same period in 2015 due primarily to additional amortization of intangibles related to the acquisition of OMT. Research and development expense was $6.3 million, compared with $1.9 million for the same period of 2015 as a result of the addition of OMT-related expenses, timing of spending on internal development programs and non-cash stock-based compensation expense. General and administrative expense was $6.3 million, compared with $5.0 million for the same period in 2015 due to costs associated with OMT and non-cash stock-based compensation expense.

GAAP net income for the third quarter of 2016 was $0.6 million, or $0.03 per share. Adjusted net income for the third quarter of 2016 was $13.5 million, or $0.62 per diluted share, compared with adjusted net income for the same period in 2015 of $12.0 million, or $0.57 per diluted share. See “Adjusted Financial Measures” and the accompanying table below for the adjusted calculations and reconciliation to comparable GAAP financial measures.

As of September 30, 2016, Ligand had cash, cash equivalents and short-term investments of $124.1 million.

Year-to-Date Financial Results

Total revenues for the nine months ended September 30, 2016 were $70.8 million, compared with $50.7 million for the same period in 2015. Royalty revenues were $39.8 million, compared with $26.6 million for the same period in 2015 primarily due to higher royalties from Promacta® and Kyprolis®. Material sales were $13.5 million, compared with $20.5 million for the same period in 2015 due to timing of Captisol® purchases for use in clinical trials and commercial products. License and milestone revenues were $17.5 million, compared with $3.6 million for the same period in 2015 due to the addition of OmniAb revenue as of January 2016 and the timing of milestones and upfront license fees.

Cost of goods sold was $2.7 million for the nine months ended September 30, 2016, compared with $4.9 million for the same period in 2015 due to the timing and mix of Captisol® sales. Amortization of intangibles was $7.9 million, compared with $1.8 million for the same period in 2015 due primarily to additional amortization of intangibles related to the acquisition of OMT. Research and development expense was $14.8 million, compared with $8.7 million for the same period of 2015 as a result of timing of spending on internal development programs and non-cash stock-based compensation expense. General and administrative expense was $20.0 million, compared with $18.2 million for the same period in 2015 due to costs associated with OMT and non-cash stock-based compensation expense.

GAAP net income for the nine months ended September 30, 2016 was $1.5 million, or $0.07 per diluted share. Adjusted net income for the nine months ended September 30, 2016 was $45.3 million, or $2.09 per diluted share, compared with adjusted net income for the same period in 2015 of $57.3 million, or $2.75 per diluted share.

Revised Financial Forecast

The Company is revising expectations for full-year 2016 total revenues to be between $110 million and $114 million, and adjusted earnings per diluted share to be between $3.37 and $3.44. This compares to previous Company expectations for full-year 2016 total revenues to be between $115 million and $119 million, and adjusted earnings per diluted share to be between $3.41 and $3.46. The revised outlook for total revenues reflects expected lower sales for Captisol due to timing of certain regulatory and clinical events. The Company expects total revenues for the fourth quarter of 2016 to be between $39 million and $43 million, including approximately $19 million in royalty revenues. Fourth quarter adjusted earnings per diluted share is expected to be between $1.29 and $1.36. For 2017, we are maintaining our previously disclosed guidance of greater than $160 million of revenue and greater than $5.03 of adjusted earnings per diluted share.

The adjusted net income per diluted share guidance excludes non-cash stock-based compensation expense, non-cash debt-related costs, amortization related to acquisitions, changes in contingent liabilities, non-cash net losses of Viking Therapeutics equity, mark-to-market adjustment for amounts owed to licensors, fair value adjustments to Viking Therapeutics convertible note receivable and warrants, non-cash tax benefit (expense), unissued shares relating to the Senior Convertible Note and adjustments for discontinued operations, net of non-cash tax expense.

Third Quarter 2016 and Recent Business Highlights

Portfolio Program Progress

Promacta®/Revolade®

  • Novartis announced Q3 2016 net sales of Promacta® (eltrombopag) of $168 million, a $51 million or 44% increase over Q3 2015. Novartis also announced that Promacta is now approved in more than 100 countries.

Kyprolis® (carfilzomib), an Amgen Product Utilizing Captisol

  • On September 27, 2016, Amgen announced top-line results of the Phase 3 CLARION trial, which evaluated an investigational regimen of Kyprolis® (carfilzomib), melphalan and prednisone (KMP) versus Velcade® (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant. The trial did not meet the primary endpoint of superiority in progression-free survival (PFS). A Phase 3 study evaluating Kyprolis in combination with lenalidomide plus dexamethasone (KRd) versus Velcade in combination with lenalidomide plus dexamethasone (VRd) in newly diagnosed multiple myeloma patients called ENDURANCE, an investigator-sponsored study, is underway independently by the ECOG-ACRIN Cancer Research Group.
  • In July 2016, Amgen announced that the European Commission approved an extended indication for Kyprolis® (carfilzomib), to be used in combination with dexamethasone alone, for adult patients with multiple myeloma who have received at least one prior therapy. Also, Ono Pharmaceuticals, holder of Kyprolis® (carfilzomib) marketing rights in Japan, announced approval in Japan for treatment of patients with relapsed or refractory multiple myeloma.

Additional Pipeline and Partner Developments

  • Retrophin announced positive top-line results from the Phase 2 DUET study of sparsentan for the treatment of focal segmental glomerulosclerosis. 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. Additional data from the Phase 2 DUET study of sparsentan for the treatment of focal segmental glomerulosclerosis will be presented at the late-breaking High-Impact Clinical Trials oral session at the American Society of Nephrology (ASN) Kidney Week 2016.
  • Lundbeck announced FDA approval of Carnexiv™ (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Ligand earned a $1.25 million milestone payment upon approval and is entitled to receive a royalty of 2.75% on net sales of Carnexiv.
  • Melinta Therapeutics announced that it has submitted NDAs to the FDA for approval of IV and oral Baxdela™ (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). With the submission, Ligand earned a $1.5 million milestone payment. If approved, Ligand is entitled to receive a 2.5% royalty on net sales of the IV formulation of Baxdela and an additional $1.5 million approval milestone payment. Baxdela was the subject of several poster presentations at IDWeek 2016, held October 26-30 at the New Orleans Ernest N. Morial Convention Center.
  • The FDA granted orphan designation to Merck’s Noxafil for treatment of invasive aspergillosis.
  • Viking Therapeutics announced the first patient has been dosed in the company's Phase 2 clinical trial of VK2809 in patients with primary hypercholesterolemia and non-alcoholic fatty liver disease.
  • Viking Therapeutics announced positive top-line results from a proof-of-concept study of VK0214 in a mouse model of X-linked adrenoleukodystrophy (X-ALD), showing VK0214 rapidly reduced plasma very long chain fatty acid levels by more than 25% in treated animals compared with vehicle controls (p<0.01). Detailed study results were presented at the 86th Annual Meeting of the American Thyroid Association.
  • Aldeyra Therapeutics announced plans for ADX-102 (formerly NS2) for the first-ever vehicle-controlled Phase 3 clinical trial in noninfectious anterior uveitis, as well as a Phase 3 clinical trial in Sjögren-Larsson Syndrome. Aldeyra also announced the expected advancement of ADX-102 to a Phase 2b clinical trial in allergic conjunctivitis and the addition of a clinical program in dry eye syndrome.
  • Eli Lilly presented data on Prexasertib (LY2606368) demonstrating activity in patients with BRCA wild type sporadic high-grade serous ovarian cancer at the European Society for Medical Oncology 2016 Congress.
  • Merrimack Pharmaceuticals announced the FDA granted seribantumab (MM-121) Fast Track designation for development in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer whose disease has progressed following immunotherapy.
  • Lubris BioPharma announced positive results of a clinical trial that showed recombinant human lubricin demonstrated significant improvement in both signs and symptoms of dry eye disease compared to sodium hyaluronate (HA). Results were published in the September issue of The Ocular Surface.
  • Opthea announced that the Phase 1 dose-escalation study of OPT-302 met its primary objective demonstrating safety and tolerability as monotherapy and in combination with the current wet AMD standard of care Lucentis®. Opthea is recruiting patients for its Phase 2a dose-expansion trial and expects data by the end of 2016.

New Licensing Deals

  • Ligand announced worldwide license agreements with Gilead Sciences, F-Star Biotechnology Limited and TeneoBio to use certain or all of the OmniAb platform technologies to discover fully human antibodies. Ligand is eligible to receive annual access payments, sublicensing fees, milestone payments and royalties on future net sales of any antibodies discovered under these licenses.
  • Ligand announced licensing rights to four programs to Seelos Therapeutics including aplindore for the treatment of various CNS disorders, a CRTH2 antagonist for the treatment of respiratory disorders, a Captisol-enabled™ acetaminophen program for pain and fever management and an H3 receptor antagonist program for the treatment of narcolepsy. Ligand is entitled to receive milestones and net sales royalties ranging from 4% to 10% for the various programs licensed.
  • Ligand announced a license agreement for its LTP technology with Nucorion Pharmaceuticals, a venture-funded biotechnology company focused on developing anti-cancer and anti-viral agents initially directed to China, of which Ligand is a minority shareholder. Three initial programs fall under the license: NUC-202, a targeted anticancer analog for the treatment of hepatocellular carcinoma; NUC-404, a targeted nucleotide analog for the treatment of hepatitis B; and NUC-101, a targeted nucleotide analog for the treatment of hepatitis C. Ligand is eligible to receive milestones in addition to royalties ranging from 5% to 9% on future net sales of any approved program.

Internal Glucagon Receptor Antagonist (GRA) Program

  • Ligand announced initiation of a Phase 2 clinical trial with LGD-6972 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. Results from two Phase 1 clinical trials with LGD-6972 were published online in the August 2016 issue of the journal Diabetes, Obesity and Metabolism.

Adjusted Financial Measures

The adjusted financial measures discussed above and in the tables below for the three and nine months ended September 30, 2016 and 2015 exclude non-cash stock-based compensation expense, non-cash debt-related costs, amortization related to acquisitions, changes in contingent liabilities, non-cash net losses of Viking Therapeutics equity, mark-to-market adjustment for amounts owed to licensors, fair value adjustments to Viking Therapeutics convertible note receivable and warrants, non-cash tax benefit (expense), unissued shares relating to the Senior Convertible Note and adjustments for discontinued operations, net of non-cash tax expense.

Management has presented net income and net income per share on an adjusted basis. Ligand believes the presentation of adjusted financial measures provides useful supplementary information to investors and reflects amounts that are more closely aligned with the cash profits for the period. Ligand uses these adjusted financial measures in connection with its own budgeting and financial planning. These adjusted financial measures are in addition to, and not a substitute for, or superior to, measures of financial performance prepared in conformity with GAAP.

Conference Call

Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (877) 407-4019 from the U.S. or (201) 689-8337 from outside the U.S., using the passcode “Ligand.” To participate via live or replay webcast, a link will be available at www.ligand.com.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding: Ligand’s future revenue growth, including the timing, mix and volume of Captisol orders, the timing of the initiation or completion of clinical trials by Ligand and its partners, the timing of review of clinical data by the FDA, expected value creation for shareholders and guidance regarding the full-year 2016 and 2017 financial results. Actual events or results may differ from Ligand's expectations. For example, Ligand may not receive expected revenue from material sales of Captisol, expected royalties on other partnered products and research or development milestone payments. Ligand and its partners may not be able to timely or successfully advance any product(s) in its internal or partnered pipeline. In addition, Ligand's review of DTA may result in a reduction of DTA greater than currently expected. Any resulting reclassification to the 2015 financial statements may also result in Ligand's inability to rely on the auditors' opinion with respect to the 2015 financial statements and the need for a new audit of the 2015 financial statements and amended periodic reports for 2015 and 2016. In addition, there can be no assurance that Ligand will achieve its guidance for 2016 or 2017 or any portion thereof or beyond, that Ligand's 2016 or 2017 revenues will be at the levels as currently anticipated, that Ligand will be able to create future revenues and cash flows by developing innovative therapeutics, that results of any clinical study will be timely, favorable or confirmed by later studies, that products under development by Ligand or its partners will receive regulatory approval, that there will be a market for the product(s) if successfully developed and approved, or that Ligand's partners will not terminate any of its agreements or development or commercialization of any of its products. Further, Ligand may not generate expected revenues under its existing license agreements and may experience significant costs as the result of potential delays under its supply agreements. Also, Ligand and its partners may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result in increased costs and delays, or limit Ligand's ability to obtain regulatory approval. Further, unexpected adverse side effects or inadequate therapeutic efficacy of Ligand's product(s) could delay or prevent regulatory approval or commercialization. In addition, Ligand may not be able to successfully implement its strategic growth plan and continue the development of its proprietary programs. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Other Disclaimers and Trademarks

The information in this press release regarding certain third-party products and programs, including Promacta, a Novartis product and Kyprolis, an Amgen product, comes from information publicly released by the owners of such products and programs. Ligand is not responsible for, and has no role in, the development of such products or programs.

Ligand owns or has rights to trademarks and copyrights that it uses in connection with the operation of its business including its corporate name, logos and websites. Other trademarks and copyrights appearing in this press release are the property of their respective owners. The trademarks Ligand owns include Ligand®, Captisol® and OmniAb®. Solely for convenience, some of the trademarks and copyrights referred to in this press release are listed without the ®, © and TM symbols, but Ligand will assert, to the fullest extent under applicable law, its rights to its trademarks and copyrights.

LIGAND PHARMACEUTICALS, INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, in thousands)
   
Three Months Ended September 30,   Nine Months Ended September 30,
2016   2015   2016   2015  
Revenues:
Royalties $ 15,698 $ 9,755 $ 39,842 $ 26,648
Material sales 4,219 6,046 13,445 20,456
License fees, milestones and other revenues 1,702   1,900   17,500   3,618  
Total revenues 21,619   17,701   70,787   50,722  
Operating costs and expenses:
Cost of goods sold 999 1,250 2,674 4,923
Amortization of intangibles 2,706 593 7,912 1,780
Research and development 6,305 1,945 14,813 8,730
General and administrative 6,305 4,971 19,995 18,190
Non-continuing expenses 245   345   863   786  
Total operating costs and expenses 16,560   9,104   46,257   34,409  
Income from operations 5,059 8,597 24,530 16,313
Other expense:
Other expense, net (1,901 ) (1,445 ) (7,065 ) (6,986 )
Increase in contingent liabilities (958 ) 2,301 (2,595 ) (4,976 )
Gain on deconsolidation of Viking 28,190
Loss from Viking (1,396 ) (2,169 ) (14,139 ) (3,040 )
Total other expense, net (4,255 ) (1,313 ) (23,799 ) 13,188  
Income before income taxes 804 7,284 731 29,501
Income tax benefit (expense) (160 ) UR   28   UR  
Income from continuing operations including noncontrolling interests $ 644   UR   759   UR  
 
Discontinued operations:
Gain on sale of Oncology Product Line, net of tax     731    
Net income: $ 644   UR   $ 1,490   UR  
Less: net loss attributable to noncontrolling interests       (2,380 )
Net income attributable to common $ 644   UR   $ 1,490   UR  
 
Basic per share amounts:
Income from continuing operations $ 0.03 UR $ 0.04 UR
Discontinued operations     0.04    
Net income $ 0.03   UR   $ 0.07   UR  
Diluted per share amounts:
Income from continuing operations $ 0.03 UR $ 0.03 UR
Discontinued operations     0.03    
Net income $ 0.03   UR   $ 0.07   UR  
 
Weighted average number of common shares-basic 20,887 19,887 20,806 19,741
Weighted average number of common shares-diluted 22,997 21,460 22,742 21,122

UR - Under Review

 
LIGAND PHARMACEUTICALS, INCORPORATED
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
     
September 30, 2016   December 31, 2015
ASSETS
Current assets:
Cash, cash equivalents and short-term investments $ 124,115 $ 200,219
Accounts receivable, net 6,586 6,170
Note receivable from Viking 3,207 4,782
Inventory 4,027 1,633
Other current assets 2,756   1,908
Total current assets 140,691 214,712
Deferred income taxes UR UR
Goodwill and other identifiable intangible assets 279,794 60,585
Investment in Viking 17,339 29,728
Commercial license rights 25,985 8,554
Other assets 3,570   399
Total assets UR   UR
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities $ 10,937 $ 10,422
Current portion of contingent liabilities 5,079 10,414
2019 convertible senior notes, net 210,115  
Total current liabilities 226,131 20,836
2019 convertible senior notes, net 201,985
Long-term portion of contingent liabilities 3,933 3,033
Other long-term liabilities 408   297
Total liabilities 230,472   226,151
Total Ligand Pharmaceuticals stockholders' equity UR   UR
Total liabilities and stockholders' equity UR   UR

UR - Under Review

 
LIGAND PHARMACEUTICALS INCORPORATED
ADJUSTED FINANCIAL MEASURES

(Unaudited, in thousands)

   
Three months ended September 30, Nine months ended September 30,
2016   2015 2016   2015
 
 
Net income(UR) $ 644 $ 224,539 $ 1,490 $ 248,857
Non-cash stock-based compensation expense 5,331 2,836 13,690 9,511
Non-cash debt related costs 2,752 2,588 8,130 7,646
Amortization related to acquisitions 2,270 6,385
Increase in contingent liabilities 958 (2,301 ) 2,595 4,976
Loss from Viking (a) 1,396 2,169 13,923 3,040
Mark-to-market adjustment for investments owed to licensors 109 (593 ) 31 571
Fair market value adjustment on Viking note and warrants (152 ) (462 )
Non-cash tax benefit(UR) 160 (217,255 ) 257 (217,255 )
Discontinued operations, net of non-cash tax expense     (731 )  
Adjusted net income $ 13,468   $ 11,983   $ 45,308   $ 57,346  
Diluted per-share amounts attributable to common shareholders:
Net income(UR) $ 0.03 $ 10.46 $ 0.07 $ 11.78
Non-cash stock-based compensation expense 0.23 0.13 0.60 0.45
Non-cash debt related costs 0.12 0.12 0.36 0.36
Amortization related to acquisitions 0.10 0.28
Increase in contingent liabilities 0.04 (0.11 ) 0.11 0.24
Loss from Viking (a) 0.06 0.10 0.61 0.14
Mark-to-market adjustment for investments owed to licensors (0.03 ) 0.03
Fair market value adjustment on Viking note and warrants (0.01 ) (0.02 )
Non-cash tax expense(UR) 0.01 (10.12 ) 0.01 (10.29 )
2019 Senior Convertible Notes share count adjustment 0.03 0.01 0.10 0.03
Discontinued operations, net of non-cash tax expense     (0.03 )  
Adjusted net income $ 0.62   $ 0.57   $ 2.09   $ 2.75  
 
GAAP-Weighted average number of common shares-diluted 22,997 21,460 22,742 21,122
Less: 2019 Senior Convertible Notes share count adjustment 1,184 463 1,046 232
Adjusted weighted average number of common shares-diluted 21,813 20,997 21,696 20,890

(a) Loss from Viking reflects the Company’s share of Viking's net loss of $1,068 and $3,835 for the three and nine months ended September 30, 2016, respectively, and the decrease in the book value of the Company's equity method investment in Viking of $328 and $10,304 for the three and nine months ended September 30, 2016, respectively, as a result of the Company's decreased ownership percentage in Viking after Viking's financing.

(UR) - The amounts for the three and nine months ended September 30, 2015 may be adjusted as a result of the DTA review referenced in the earnings announcement.

Ligand Pharmaceuticals Incorporated
Todd Pettingill, 858-550-7500
investors@ligand.com
Twitter: @Ligand_LGND
or
LHA
Bruce Voss, 310-691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

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Ligand Partner Melinta Therapeutics Submits Baxdela New Drug Application for Hospital-Treated Skin Infections http://investor.ligand.com/news/detail/306/ligand-partner-melinta-therapeutics-submits-baxdela-new-drug-application-for-hospital-treated-skin-infections Mon, 24 Oct 2016 09:21:00 -0400 http://investor.ligand.com/news/detail/306/ligand-partner-melinta-therapeutics-submits-baxdela-new-drug-application-for-hospital-treated-skin-infections

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner Melinta Therapeutics, a privately held company developing novel antibiotics to treat serious bacterial infections, announced today that it has submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for approval of IV and oral Baxdela™ (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Baxdela is an investigational anionic fluoroquinolone with a broad spectrum of antimicrobial activity, including activity against methicillin-resistant Staphylococcus aureus (MRSA). Melinta’s NDAs are based on the results of two Phase 3 studies (NCT01811732 and NCT01984684), in both of which Baxdela met the primary endpoint of non-inferiority to a combination regimen of vancomycin plus aztreonam in reducing lesion size at the primary infection site at 48-to-72 hours. In addition, Baxdela met the primary endpoint, the investigator assessment of clinical cure, for the European Medicines Agency (EMA) in both studies. Baxdela was shown to be well-tolerated among Phase 3 study participants, with less than 1% of patients discontinuing for treatment-related adverse events. With the submission, Ligand has earned a $1.5 million milestone payment. If approved, Ligand is entitled to receive a 2.5% royalty on net sales of the IV formulation of Baxdela and an additional $1.5 million approval milestone payment.

“Baxdela, if approved, represents a potentially attractive treatment option for the nearly 3 million patients hospitalized annually in the U.S. with serious skin infections,” stated Eugene Sun, M.D., Melinta’s Chief Executive Officer. “These patients have a high rate of treatment failure, and frequently have underlying medical conditions that pose challenges to the choice of antibiotic. Baxdela has been tested in over 2,600 patients to date, and was well-tolerated with fewer than 1% of Baxdela-treated patients discontinuing due to treatment-related adverse events.”

Baxdela has been designated a Qualified Infectious Disease Product (QIDP) by the U.S. FDA, which provides for priority review. According to Melinta’s press release, Melinta could receive a regulatory decision by mid-year 2017 consistent with Prescription Drug User Fee Act (PDUFA) priority review timelines.

“Baxdela has demonstrated in clinical trials a broad spectrum of activity and the ability to treat patients with serious co-morbidities, both of which are compelling characteristics sought by physicians according to our market research. We believe that Baxdela’s ability to treat challenging patients in hospitals will be a major driver of adoption,” concluded John Temperato, Melinta’s President and Chief Operating Officer. “If approved, we plan to support the introduction of Baxdela for the treatment of ABSSSI with a focused acute-care hospital sales force. We believe we can further leverage the resources of such a sales team in the future as we seek to complete clinical studies and file applications to market Baxdela in additional indications such as community-acquired bacterial pneumonia and complicated urinary tract infections.”

About Baxdela

Baxdela (delafloxacin) is an investigational anionic fluoroquinolone antibiotic for hospital-treated skin infections, known as acute bacterial skin and skin structure infections (ABSSSI). Baxdela has robust in-vitro antimicrobial activity, including activity against methicillin-resistant Staphylococcus aureus (MRSA), a major cause of hospital-treated skin infections, a favorable tolerability profile, and both intravenous and oral dosage forms, which may facilitate hospital discharge. The studies (studies 302 and 303) were Phase 3, multicenter, randomized, double-blind, active-controlled trials to evaluate IV and oral Baxdela compared with vancomycin plus aztreonam for the treatment of patients with ABSSSI. Both studies met the primary endpoints for efficacy.

Overall adverse event rates were similar between treatment arms in the Phase 3 studies, which enrolled over 1,500 individuals. The most common treatment-emergent adverse events in the Phase 3 studies on Baxdela were diarrhea and nausea, which were generally mild and did not lead to treatment discontinuation. The treatment discontinuation rate due to treatment-related adverse events for patients treated with Baxdela in the Phase 3 trials was 0.8%. Unlike some other quinolones, Baxdela has not shown any potential for QT prolongation or phototoxicity in definitive clinical studies. In addition, there were no elevated rates of liver or glucose abnormalities compared to vancomycin plus aztreonam in the clinical studies conducted to date.

The 450 mg tablet has been shown to have bioequivalent exposure (area under the curve) to the 300 mg IV dose, and can be dosed without regard to food. There are no anticipated drug-drug interactions with delafloxacin other than co-administration with chelating agents.

Melinta is also assessing Baxdela in a clinical trial in patients with hospital-treated community-acquired bacterial pneumonia (CABP) and planning to initiate a clinical trial in complicated urinary tract infections (cUTI) in the near future. Baxdela has been designated a Qualified Infectious Disease Product (QIDP) and has been granted fast track designation for community-acquired bacterial pneumonia by the U.S. Food and Drug Administration.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono- and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies, including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These include statements regarding the timing of review and approval, if any, by the FDA of the Baxdela NDA; the timing of the $1.5 million payment payable to Ligand; the potential payments to Ligand upon approval of Baxdela; and the description of the side effects for Baxdela. Actual events or results may differ from our expectations. For example, there can be no assurances that the FDA will approve Baxdela or that, if approved, Melinta will successfully launch Baxdela; the side effects or efficacy of Baxdela may prove different or worse than the results from previous clinical trials; and Baxdela may not be accepted as a treatment option by doctors and other health professionals. In addition, there can be no assurance that Melinta will make the required milestone payment. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other important risk factors affecting Ligand can be found in Ligand's prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission, available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Ligand Pharmaceuticals Incorporated
Todd Pettingill
investors@ligand.com
(858) 550-7500
or
LHA
Bruce Voss
bvoss@lhai.com
(310) 691-7100

Source: Ligand Pharmaceuticals Incorporated

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Ligand Announces Third Quarter 2016 Earnings Release Date and Participation in the Stephens Fall Investment Conference http://investor.ligand.com/news/detail/305/ligand-announces-third-quarter-2016-earnings-release-date-and-participation-in-the-stephens-fall-investment-conference Thu, 13 Oct 2016 09:00:00 -0400 http://investor.ligand.com/news/detail/305/ligand-announces-third-quarter-2016-earnings-release-date-and-participation-in-the-stephens-fall-investment-conference

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today plans to report third quarter 2016 financial results on November 3, 2016. Ligand’s CEO John Higgins, President and COO Matt Foehr and CFO Matt Korenberg will host the conference call. Ligand also announced participation in the upcoming Stephens Fall Investment Conference.

Third Quarter Earnings Call

What:       Ligand conference call to discuss financial results and provide general business updates
 
When: Thursday, November 3, 2016
 
Time: 4:30 p.m. Eastern time (1:30 p.m. Pacific time)
 
Conference Call: (877) 407-4019 within the U.S.
(201) 689-8337 outside the U.S.
Passcode: Ligand
 
Webcast:

Live conference call webcast and replay accessible at www.ligand.com

Investment Conference

Ligand executives are scheduled to participate in the upcoming Stephens Fall Investment Conference in New York on Wednesday, November 9, 2016 at 1:00 p.m. Eastern time (10:00 a.m. Pacific time). John Higgins, CEO and Matt Korenberg, CFO will present for Ligand. A live webcast will be accessible at www.ligand.com and replay will be available for 30 days.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. 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. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.

Follow Ligand on Twitter @Ligand_LGND.

Ligand Pharmaceuticals Incorporated
Todd Pettingill
(858) 550-7500
investors@ligand.com
or
LHA
Bruce Voss
(310) 691-7100
bvoss@lhai.com

Source: Ligand Pharmaceuticals Incorporated

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