On November 5, 2019 Boston Scientific Corporation (the "Company") (NYSE:BSX) reported that, pursuant to the previously announced cash tender offer (the "Tender Offer") for up to $1.0 billion aggregate principal amount (the "Aggregate Maximum Principal Amount") of the outstanding senior notes listed in the table below (the "Securities"), approximately $1.6 billion in aggregate principal amount of the Securities were validly tendered and not validly withdrawn on or prior to 5:00 p.m., Eastern Standard Time (EST), on November 4, 2019 (the "Early Tender Date") (Press release, Boston Scientific, NOV 5, 2019, View Source [SID1234550378]). Withdrawal rights for the Tender Offer expired at 5:00 p.m. EST on November 4, 2019, and, accordingly, Securities validly tendered in the Tender Offer may no longer be withdrawn except where additional withdrawal rights are required by law.

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The table below summarizes certain information regarding the Securities and the Tender Offer, including the aggregate principal amount of each series of Securities that were validly tendered and not validly withdrawn on or prior to the Early Tender Date, and the order of priority and purchase price information for the Securities.

The offer with respect to the Securities is subject to the Aggregate Maximum Principal Amount. The Company will purchase up to the Aggregate Maximum Principal Amount of its Securities, subject to the Acceptance Priority Level as set forth in the table above (each, an "Acceptance Priority Level"). The Company reserves the right, but is under no obligation, to increase the Aggregate Maximum Principal Amount at any time, including on or after November 5, 2019 (the "Price Determination Date"), subject to applicable law.

Proration Factor is rounded to the nearest tenth of one percent.

The Tender Offer is being made pursuant to an Offer to Purchase, dated October 22, 2019 (the "Offer to Purchase"), which sets forth the terms and conditions of the Tender Offer. The Tender Offer will expire at midnight EST on November 19, 2019 (one minute after 11:59 p.m. EST on November 19, 2019), or any other date and time to which such Tender Offer is extended (such date and time, as it may be extended with respect to a Tender Offer, the "Expiration Date"), unless earlier terminated. However, because the aggregate principal amount of Securities validly tendered and not validly withdrawn would cause the Aggregate Maximum Principal Amount to be exceeded and the Company does not expect to increase the Aggregate Maximum Principal Amount, the Company does not expect to accept any further tenders of Securities.

Holders of Securities that validly tendered and did not validly withdraw their Securities prior to the Early Tender Date are eligible to receive the Total Consideration (as defined below), which is inclusive of the "Early Tender Payment" of $30 per $1,000 principal amount of validly tendered and accepted Securities. The consideration (the "Total Consideration") offered per $1,000 principal amount of Securities of each series of Securities validly tendered and accepted for purchase pursuant to the Tender Offer will be determined in the manner described in the Offer to Purchase by reference to the applicable "Fixed Spread" for such Securities specified in the table above plus the applicable yield to maturity based on the bid-side price of the applicable "U.S. Treasury Reference Security" specified in the table above as quoted on the applicable page on the Bloomberg Bond Trader at 11:00 a.m. EST today, November 5, 2019, the first business day following the Early Tender Date. The Total Consideration will be determined by taking into account the applicable par call date for each series of Securities, if any. The Company expects to issue a press release today after the close of trading on the New York Stock Exchange to announce the Total Consideration payable in connection with the Tender Offer.

All holders of Securities accepted for purchase will also receive accrued and unpaid interest on Securities validly tendered and accepted for purchase from the applicable last interest payment date up to, but not including, the settlement date.

Securities tendered prior to or at the Early Tender Date and accepted for purchase will be accepted based on the Acceptance Priority Levels noted on the table above, with 1 being the highest Acceptance Priority Level and 4 being the lowest Acceptance Priority Level, and will have priority over Securities tendered after the Early Tender Date, regardless of the Acceptance Priority Levels of the Securities tendered after the Early Tender Date. Because the aggregate principal amount of Securities validly tendered and not validly withdrawn prior to the Early Tender Date would cause the Aggregate Maximum Principal Amount to be exceeded, such Securities will be purchased subject to the Acceptance Priority Levels and subject to proration as described in the Offer to Purchase and the table above. Any tendered Securities not accepted for purchase will be promptly credited to the Holder’s account with DTC or otherwise returned to the Holder without cost.

The settlement date for the Securities that are validly tendered on or prior to the Early Tender Date is expected to be November 12, 2019, the fifth business day after the Early Tender Date, assuming the conditions to the satisfaction of the Tender Offer are satisfied.

The Company’s obligation to accept for payment and to pay for the Securities validly tendered in the Tender Offer is not subject to any minimum tender condition but is subject to the satisfaction or waiver of the conditions described in the Offer to Purchase, including the financing condition that the Company shall have closed one or more debt financings resulting in net proceeds in an amount, together with cash on hand, not less than the amount required, upon the terms and subject to the conditions of the Tender Offer, to purchase all the Securities validly tendered and accepted for purchase in the Tender Offer and to pay accrued interest thereon and fees and expenses associated therewith. The Company reserves the right, subject to applicable law, to: (i) waive any and all conditions to the Tender Offer; (ii) extend or terminate the Tender Offer; (iii) increase or decrease the Aggregate Maximum Principal Amount; or (iv) otherwise amend the Tender Offer in any respect.

The Company or its affiliates may also from time to time, after completion of the Tender Offer, purchase additional Securities in the open market, in privately negotiated transactions, through tender or exchange offers or otherwise, or the Company may redeem Securities that are redeemable pursuant to their terms.

Information Relating to the Tender Offer

Barclays Capital Inc., BofA Securities and Goldman Sachs & Co. LLC are acting as the lead dealer managers (the "Lead Dealer Managers") for the Tender Offer. The information agent and tender agent for the Tender Offer is D.F. King & Co., Inc. (the "Tender and Information Agent"). Copies of the Offer to Purchase are available by contacting the Tender and Information Agent at (866)-406-2285 (U.S. toll-free) or (212)-269-5550 (banks and brokers) or email at [email protected]. Questions regarding the Tender Offer should be directed to Barclays Capital Inc., Liability Management Group at (212) 528-7581 (collect) or (800) 438-3242 (toll free), BofA Securities, Liability Management Group at (980) 387-3907 (collect) or (888) 292-0070 (toll-free) or Goldman Sachs & Co. LLC, Liability Management Group at (212) 902-6351 (collect) or (800) 828-3182 (toll-free). Citigroup Global Markets Inc., Deutsche Bank Securities Inc., J.P. Morgan Securities LLC and Wells Fargo Securities, LLC are acting as the co-dealer managers for the Tender Offer (collectively with the Lead Dealer Managers, the "Dealer Managers").

None of the Company, its affiliates, their respective boards of directors or managing members, the Dealer Managers, the Tender and Information Agent or the trustee with respect to any series of Securities is making any recommendation as to whether holders of Securities should tender any Securities in response to the Tender Offer, and neither the Company nor any such other person has authorized any person to make any such recommendation. Holders of Securities must make their own decision as to whether to tender any of their Securities, and, if so, the principal amount of Securities to tender.

This press release shall not constitute an offer to sell, a solicitation to buy or an offer to purchase or sell any securities. The Tender Offer is being made only pursuant to the Offer to Purchase and only in such jurisdictions as is permitted under applicable law.

The full details of the Tender Offer, including complete instructions on how to tender Securities, are included in the Offer to Purchase. The Offer to Purchase contains important information that should be read by holders of Securities before making a decision to tender any Securities.

On November 5, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, reported that the United States Food and Drug Administration (FDA) has granted AUTO1 orphan drug designation for treatment of acute lymphoblastic leukemia (ALL) patients (Press release, Autolus, NOV 5, 2019, View Source [SID1234550683]).

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According to the National Institute of Health’s National Cancer Institute, in the United States, there will be an estimated 5,930 new cases of ALL and an estimated 1,500 related deaths in 2019. Patients are predominantly children; approximately 60% of cases occur at age < 20 years. ALL occurs when the bone marrow makes too many immature lymphocytes, which are a type of white blood cell. Despite a high rate of response to induction chemotherapy, only 30–40% of adult patients with ALL will achieve long-term remission. Similarly, pediatric patients typically respond well to first-line treatment (combination chemotherapy) but 10 to 20% of total patients relapse with chemotherapy-resistant disease, leading to a significant unmet need in pediatric patients with high-risk relapsed or refractory ALL.

"We are pleased to receive orphan drug designation for AUTO1 for acute lymphoblastic leukemia," said Dr. Christian Itin, chairman and chief executive officer of Autolus. "From the data reported in our ongoing studies, we have seen strong remission rates and excellent CAR T cell expansion and persistence without inducing high-grade CRS, a serious adverse event affecting a significant number of patients on currently available CAR T treatments. We look forward to presenting data on AUTO1 at ASH (Free ASH Whitepaper) at the end of the year."

Orphan drug designation is granted by the FDA Office of Orphan Products Development to drugs and biologics which are intended for the treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Under the Orphan Drug Act, the FDA may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the United States following marketing approval by the FDA. For more information about orphan designation, please visit the FDA website at www.fda.gov.

About AUTO1
AUTO1 is a CD19 CAR T cell investigational therapy designed to overcome the limitations in safety – while maintaining similar levels of efficacy – compared to current CD19 CAR T cell therapies. Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, AUTO1 may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the T cells’ abilities to engage in serial killing of target cancer cells. In 2018, Autolus signed a license agreement under which Autolus acquired global rights from UCL Business plc (UCLB), the technology-transfer company of UCL, to develop and commercialize AUTO1 for the treatment of B cell malignancies. AUTO1 is currently being evaluated in two Phase 1 studies, one in pediatric ALL and one in adult ALL.

On November 5, 2019 Heat Biologics, Inc. (NASDAQ:HTBX), a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer, reported that an abstract has been posted on The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) website in connection with the Company’s planned poster presentation at SITC (Free SITC Whitepaper)’s 34th Annual Meeting on November 8, 2019 (Press release, Heat Biologics, NOV 5, 2019, View Source [SID1234550287]).

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The abstract summarizes the latest interim top line data from Cohort B of the Company’s Phase 2 trial of the Company’s "off-the-shelf" cell-based therapy, HS-110, in combination with Opdivo (Nivolumab) in advanced non-small cell lung cancer (NSCLC), which completed enrollment in July 2019. This cohort enrolled patients who had previously received a checkpoint inhibitor (CPI) and whose disease had subsequently progressed. The data suggests that re-challenging the immune system with nivolumab and HS-110 after checkpoint inhibitor treatment failure may restore responsiveness and clinical benefit. Additionally, the combination of HS-110 and nivolumab is well-tolerated, and no increase in the incidence of immune-related adverse events was observed to date, as compared to CPI monotherapy. The full abstract is available at: View Source

Jeff Wolf, Heat Biologics’ CEO, commented, "NSCLC patients who progressed after checkpoint inhibitor treatment have limited therapeutic options. The latest results are encouraging and suggest that HS-110 in combination with nivolumab may address this key unmet medical need. As of this data cut, the median overall survival (OS) is estimated to be 11.8 months, with 70% of the patients still alive. I am unaware of any published checkpoint combination studies that offered superior OS in patients that had experienced previous checkpoint inhibitor treatment failure in NSCLC. This data also compares favorably to reported studies using chemotherapy following checkpoint inhibitor progression 1, 2 ".

Signals of clinical efficacy were observed in the reported objective response rate (ORR), disease control rate (DCR) and progression free survival (PFS). Importantly, patients experiencing dermal injection site reactions (ISR) had statistically significant improvement in PFS and OS compared to those without ISR (Hazard Ratio = 0.40, p=0.0068 and Hazard Ratio = 0.16, p=0.0005, respectively). Additional data will be presented at SITC (Free SITC Whitepaper) on November 8 ,2019.

Details of Heat Biologics’ poster presentation:

Abstract Title: Treating advanced non-small lung cancer (NSCLC) patients after checkpoint inhibitor treatment failure with a novel combination of Viagenpumatucel-L (HS-110) plus nivolumab

Poster #: P411
Date: Friday, November 8, 2019, 7am – 8pm (Eastern Time)
Location: Gaylord National Hotel & Convention Center, Washington DC

References:

1 Costantini A, Corny J, Fallet V et al. Efficacy of next treatment received after nivolumab progression in patients with advanced nonsmall cell lung cancer. ERJ Open Res. 2018 Apr 20;4(2).

2 Schvartsman G, Peng SA, Bis G, et al. Response rates to single-agent chemotherapy after exposure to immune checkpoint inhibitors in advanced non-small cell lung cancer. Lung Cancer. 2017 Oct;112:90-95.

On November 5, 2019 Genecast (Beijing) Technology reported that it closed a $43 million Series D financing to expand its non-invasive cancer diagnostic business (Press release, ChinaBio, NOV 5, 2019, View Source [SID1234550315]). Founded in 2014, Genecast has developed a circulating tumor DNA detection technology that provides individualized cancer diagnoses. The company offers oncology diagnostic products and services to China biopharmas, collaborating with more than 20 biopharmas and providing comprehensive pre-clinical and clinical testing services. The D round, which brings Genecast’s total VC backing to $93.5 million, was led by CICC Capital.

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On November 5, 2019 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported financial results for the three and nine months ended September 30, 2019 and provided an operating forecast and program updates (Press release, Ligand, NOV 5, 2019, View Source [SID1234550331]). Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time to discuss this announcement and answer questions.

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"We are very pleased with how the company is performing as we approach the end of the year," said John Higgins, Chief Executive Officer of Ligand. "In the past quarter we had new products and market launches from our partnered portfolio that we expect to drive increased royalties. Substantial new data were announced for late-stage or marketed products that hold the promise for further revenue growth. In addition, we acquired a company to further expand our antibody discovery business and closed new licensing deals, adding to our large partner portfolio. Financially, the business is strong in regards to both the balance sheet and the financial growth outlook. We are doing well as a company and are pleased to expand our Board last month with the addition of Sarah Boyce, a talented and accomplished biotech executive."

Third Quarter 2019 Financial Results

Total revenues for the third quarter of 2019 were $24.8 million, compared with $45.7 million for the same period in 2018. Royalties in the third quarter of 2019 were $9.8 million and primarily consisted of royalties from Kyprolis and EVOMELA. Royalties in the third quarter of 2018 were $36.1 million and included royalties from Promacta, which was sold to Royalty Pharma as of March 6, 2019, for $827 million; Ligand did not receive any Promacta royalties in the third quarter of 2019 and will not receive any Promacta royalties going forward. Material sales were $6.8 million for the third quarter of 2019, compared with $7.0 million for the same period in 2018. License fees, milestones and other revenues were $8.2 million for the third quarter of 2019, compared with $2.5 million for the same period in 2018.

Cost of material sales was $3.1 million for the third quarter of 2019, compared with $1.5 million for the same period in 2018, with higher costs due to the mix of Captisol sales. Amortization of intangibles was $3.6 million for the third quarter of 2019, compared with $5.7 million for the same period in 2018. Research and development expense was $13.7 million for the third quarter of 2019, compared with $5.5 million for the same period of 2018, with the increase due to costs associated with the Vernalis Design Platform ("VDP") research team and non-cash amortization of the upfront investments in the Palvella and Novan programs. General and administrative expense was $9.5 million, compared with $9.6 million for the same period in 2018.

Net loss for the third quarter of 2019 was $15.3 million, or $0.81 per diluted share, compared with net income of $67.4 million, or $2.80 per diluted share, for the same period in 2018. The third quarter of 2019 net loss was affected by a non-cash change in the value of Ligand’s investments of $10.5 million, while the third quarter of 2018 net income was affected by a net non-cash $59.3 million gain from the value of Ligand’s investments. Adjusted net income for the third quarter of 2019 was $9.5 million, or $0.49 per diluted share, compared with $31.7 million, or $1.32 per diluted share, for the same period in 2018. The third quarter 2019 adjusted diluted EPS was impacted by a change in tax assumptions resulting in a reduction of EPS by $0.12 in the quarter. Please see the table below for a reconciliation of net loss to adjusted net income.

As of September 30, 2019, Ligand had cash, cash equivalents and short-term investments of $1.1 billion. Cash used for share repurchases in the third quarter of 2019 was approximately $181.2 million, which repurchased approximately 1.8 million shares.

Year-to-Date Financial Results

Total revenues for the nine months ended September 30, 2019 were $93.3 million, compared with $191.9 million for the same period in 2018. Royalties in the nine months ended September 30, 2019 were $35.9 million, compared with $88.3 million for the nine months ended September 30, 2018. Royalties for the nine months ended September 30, 2019 primarily consisted of royalties from Promacta, Kyprolis and EVOMELA and do not include contribution from Promacta after March 6, 2019, whereas 2018 royalties included a full nine months of Promacta royalties. Material sales were $24.4 million, compared with $19.0 million for the same period in 2018, with the change due to the timing of Captisol purchases for use in clinical trials and commercial products. License fees, milestones and other revenues were $33.0 million, compared with $84.5 million for the same period in 2018, which included a $47 million payment from WuXi Biologics to amend its OmniAb platform license agreement as well as a $20 million upfront payment upon the licensing of Ligand’s GRA program.

Cost of material sales was $9.4 million for the nine months ended September 30, 2019, compared with $3.4 million for the same period in 2018, with the change due to higher sales and mix of Captisol sales in 2019. Amortization of intangibles was $10.6 million, compared with $12.3 million for the same period in 2018. Research and development expense was $37.2 million, compared with $19.0 million for the same period of 2018, with the increase due to costs associated with recent acquisitions. General and administrative expense was $31.6 million, compared with $26.6 million for the same period in 2018, with the increase due to costs associated with recent acquisitions and non-cash stock-based compensation expense.

Net income for the nine months ended September 30, 2019 was $636.7 million, or $31.29 per diluted share, compared with $185.8 million, or $7.61 per diluted share, for the same period in 2018. Net income for the nine months ended September 30, 2019 was impacted by an after-tax gain of approximately $643 million on the sale of Ligand’s Promacta license to Royalty Pharma. Adjusted net income from continuing operations for the nine months ended September 30, 2019 was $48.2 million, or $2.37 per diluted share after taking into account the tax changes primarily related to Promacta, compared with $127.9 million, or $5.44 per diluted share, for the same period in 2018. Please see the table below for a reconciliation of net income to adjusted net income.

2019 Financial Guidance

Ligand is affirming its revenue guidance for 2019 with total revenues expected to be approximately $118 million. Revenues, cost of goods and operating expenses are all performing in line with expectations and guidance. Ligand is updating its guidance for adjusted diluted EPS to $3.00 per share from $3.20 per share previously to account for changes in tax expense allocated to adjusted EPS compared with initial estimates, primarily related to the $827 million sale of the Promacta royalty earlier this year.

Third Quarter 2019 and Recent Business Highlights

OmniAb Platform Updates

Acquisition and New Licenses

Ligand acquired Ab Initio Biotherapeutics for $12 million. Ab Initio has a patented antigen technology that is synergistic with the OmniAb therapeutic antibody discovery platform, providing Ligand’s current and potential new partners enhanced capabilities for the discovery of therapeutic antibodies against difficult-to-access cellular targets. Ab Initio has a collaboration agreement with Pfizer to discover novel therapeutic antibodies against an undisclosed target in the G-protein coupled receptor superfamily.
Ligand entered into new OmniAb license agreements with Takeda, GigaGen, Talem Therapeutics, Kira Pharma and AbVivo.
Select OmniAb Partner Updates

CStone Pharmaceuticals released pooled safety data from the Phase 1b (GEMSTONE-101) study of their anti-PD-L1 antibody CS1001 in a poster presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress, demonstrating the promising safety and tolerability profile of CS1001.
CStone Pharmaceuticals announced results from the esophageal squamous cell carcinoma cohort of a Phase 1b clinical trial of CS1001 in an oral presentation at the 22nd Annual Meeting of the Chinese Society of Clinical Oncology.
Recent OmniAb Publications

A paper by Ligand scientists entitled "Discovery of high affinity, pan-allelic, and pan-mammalian reactive antibodies against the myeloid checkpoint receptor SIRPα" was published in the journal mAbs.
Other Licensing and Acquisition Events

Ligand entered a license and supply agreement with SQ Innovation AG for use of Ligand’s Captisol technology in the formulation of high-concentration furosemide for the treatment of edema in patients with heart failure. Ligand is eligible to receive potential milestone payments and royalties, as well as revenue from Captisol materials sales.
Ligand entered into new Captisol clinical use or license and supply agreements with Millennium/Takeda, BendaRx Corporation, Hikma, the University of Edinburgh and Quadria Bio.
Additional Pipeline and Partner Developments

Kyprolis third quarter sales totaled $280 million, consisting of Amgen-reported October 29, 2019 Q3 sales of Kyprolis of $266 million and Ono Pharmaceutical Co.-reported October 30, 2019 Q3 sales of Kyprolis in Japan of $14 million.
On September 13, 2019 Amgen announced the Phase 3 CANDOR study evaluating Kyprolis in combination with dexamethasone and Darzalex compared to Kyprolis and dexamethasone alone met its primary endpoint of progression-free survival. The regimen resulted in a 37% reduction in the risk of progression or death in patients with relapsed or refractory multiple myeloma treated with KdD and the median PFS for patients treated with Kd alone was 15.8 months.
Amgen announced on October 31 that it has entered into a strategic collaboration with BeiGene to expand its oncology presence in China. BeiGene is an oncology-focused biotechnology company with an established commercial and clinical development organization in China. Under the agreement, BeiGene will commercialize Kyprolis in China over the next 5 to 7 years along with two other oncology products, Xgeva and Blincyto. Amgen and BeiGene will share the profits and losses equally. Kyprolis is currently in a Phase 3 trial in China.
CASI Pharmaceuticals launched Evomela in China; Evomela uses Ligand’s Captisol technology in its formulation.
Retrophin announced that it will present new data from the Phase 2 DUET Study examining the impact of sparsentan on quality of life in focal segmental glomerulosclerosis at the American Society of Nephrology (ASN) Kidney Week 2019.
Novan completed patient recruitment in the B-SIMPLE (Berdazimer Sodium In Molluscum Patients with Lesions) Phase 3 pivotal trials with SB206 for the treatment of molluscum contagiosum. Novan affirmed that topline data from these trials are expected in the first quarter of 2020.
Sage Therapeutics launched Zulresso (brexanolone) injection. With this launch, Zulresso is the 11th FDA-approved drug to use Ligand’s Captisol technology.
Sermonix Pharmaceuticals announced enrollment and dosing of the first patient into a Phase 2 clinical trial of its lead investigational drug, lasofoxifene, and announced completion of a $26 million financing to fund the trial through to completion.
Verona Pharma presented data from a Phase 2b trial with nebulized ensifentrine in chronic obstructive pulmonary disease (COPD) at the CHEST Annual Meeting and presented data from a Phase 2 trial with its dry powder inhaler formulation of ensifentrine in COPD at the European Respiratory Society International Congress.
Marinus Pharmaceuticals announced that results from its Phase 2 trial of ganaxolone in Refractory Status Epilepticus (RSE) were presented at the Neurocritical Care Society 17th Annual Meeting in Vancouver, BC. Ganaxolone met the primary endpoint in the study with none of the 17 patients progressing to IV anesthetics within 24 hours of treatment initiation.
In September, results of a randomized Phase 2 study of M6620, an ATR kinase inhibitor in development by Merck KGaA formulated using Captisol, were presented at ESMO (Free ESMO Whitepaper) 2019 demonstrating that the addition of M6620 to gemcitabine extended PFS without additional toxicity in patients with platinum-resistant, high-grade serous ovarian cancer.
Takeda Pharmaceutical announced results of a Phase 1 clinical proof-of-concept study of Captisol-enabled TAK-925, a selective orexin type-2 receptor (OX2R) agonist, in individuals with narcolepsy type 1.
Opthea announced positive Phase 2b results demonstrating that OPT-302 combination therapy met the primary endpoint of superiority in mean visual acuity gain at 24 weeks compared to Lucentis monotherapy in treatment-naïve patients with wet age-related macular degeneration; these data were presented at the European Society of Retina Specialists 2019 Congress.
Nucorion Pharmaceuticals closed a $5 million Series B financing to support the Phase 1 clinical development in the U.S. for its lead program, NCO-1010, for the treatment of hepatitis B; NCO-1010 utilizes Ligand’s LTP Platform technology.
Internal R&D

Ligand announced positive topline results from a Phase 1 clinical trial of its internal Captisol-enabled Iohexol program. Clinical data will be presented at ASN Kidney Week 2019 in Washington, DC on November 8th, 2019 and the 2019 Contrast Media Research Symposium in Erice, Italy on November 11th, 2019.
Corporate Events

Ligand announced the appointment of Sarah Boyce to the Company’s Board of Directors, increasing the total number of Ligand directors to nine. Ms. Boyce brings a breadth of commercial and business development experience that will be valuable as the Company builds its portfolio of tools and drug discovery technologies to help serve the pharmaceutical industry.
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 and intangible assets, changes in contingent liabilities, mark-to-market adjustments for amounts relating to its equity investments in public companies, excess tax benefit from share-based compensation, unissued shares relating to its Senior Convertible Notes, gain on the sale of Promacta and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included at the end of this press release. However, other than with respect to total revenues, the Company only provides financial 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, changes in the market value of its investments in public companies, stock-based compensation expense and effects of any discrete income tax items. 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 (833) 591-4752 from the U.S. or (720) 405-1612 from outside the U.S., using the conference ID 6093759. To participate via live or replay webcast, a link is available at www.ligand.com.