Nucorion Pharmaceuticals, Inc.

国内创新药IND       1、德琪医药：ATG-037 作用机制：CD73抑制剂 适应症：实体瘤 6月12日，德琪医药的ATG-037的临床试验申请（IND）获CDE受理。ATG-037是一款口服CD73小分子抑制剂，可逆转由腺苷介导的免疫抑制效应。在临床前研究中，ATG-037单药以及与ICI或化疗药物的联用显示了良好的抗肿瘤活性，且可克服抗CD73抗体药物治疗中常见的 “钩状效应”；此外，GLP药物毒理学研究显示该药物的治疗窗口较宽。       2、宝船生物：BC011抗体注射液 作用机制：TNFR2抗体 适应症：肿瘤 6月12日，宝船生物的BC011抗体注射液的IND获CDE受理。BC011是一款新型的TNFR2非阻断治疗抗体，2020年，宝船生物与百奥赛图达成合作，双方共同开发BC011项目。临床前研究表明，与其他TNFR2抗体产品相比，BC011在体外能够有效促进CD8+T细胞增殖；此外，在人源化的TNFR2肿瘤同源小鼠模型中，BC011单一疗法在剂量依赖性方式下可显著抑制肿瘤生长。与人源化抗PD-1或PD-L1抗体联用，和单药相比，BC011也显著提高了抗肿瘤活性。同时，BC011抗体显著增加了肿瘤微环境中Teff/Treg的比率，在TNFR2人源化小鼠中也显示了良好的耐受性，剂量增加到100 mg/kg仍未观察到产品相关毒性。       3、海创：HP515片 作用机制：THRβ激动剂 适应症：非酒精性脂肪肝 6月12日，海创药业的HP515片的IND获CDE受理。HP515是一款甲状腺激素受体β（THR-β）激动剂，目前正在开发用于非酒精性脂肪性肝炎（NASH）。THR-β是主要的肝脏甲状腺激素（TH）受体，对胆固醇和甘油三酯水平的代谢发挥关键作用。NASH是非酒精性脂肪肝病（NAFLD）从肝脂肪变性进展到肝硬化中间的一个阶段，其主要病理特征肝细胞大泡性脂肪变伴肝细胞损伤和炎症与酒精性肝炎相似，通常好发于无过量饮酒史的中年超重肥胖人群。NASH 与2 型糖尿病和高脂血症等代谢紊乱关系密切，因此又称代谢功能障碍相关脂肪性肝炎（MASH）。       4、首药控股：SY-7166片 作用机制：—— 适应症：多发性骨髓瘤 6月12日，首药控股的SY-7166片的IND获CDE受理。SY-7166是一款新型的选择性蛋白酶体小分子抑制剂，可用于多发性骨髓瘤 （MM）的治疗。该药物具有良好的临床前抗肿瘤活性、安全性优良，与其它药物联合，有望提高MM现有疗法的安全性和依从性。       5、吉源生物：人GLP-1和FGF21双因子高表达脂肪干细胞注射液 作用机制：—— 适应症：2型糖尿病 6月13日，吉源生物的人GLP-1和FGF21双因子高表达脂肪干细胞注射液的IND获CDE受理。该药物创造性地利用基因技术将肠源性多肽（GLP-1）和肝脏分泌的细胞因子（FGF21）与脂肪间充质干细胞相融合，研发出能够协同靶向调节糖脂代谢异常的CAR-Like间充质干细胞；不但能实现GLP-1和FGF21对糖脂代谢的调控作用，还可利用其归巢特性实现靶向局部治疗，起到保护胰岛β细胞和抑制并发症的疗效，在矫正2型糖尿病代谢紊乱和修复组织器官等方面取得突破性成果。       6、集宝医药：NCO-48F1片 作用机制：—— 适应症：乙肝 6月13日，集宝医药的NCO-48F1片的IND获CDE受理。NCO-48F由丰诚集团旗下广东集宝医药与美国Nucorion公司合作开发的一种新型治疗乙肝新药，目前已在美国完成了Ia期临床试验，显示安全耐受性良好；Ib期临床试验在美国正在进行中。 国内创新药上市获批       1、礼来：高血糖素鼻用粉雾剂 作用机制：重组glucagon 适应症：低血糖 6月12日，礼来的高血糖素鼻用粉雾剂（商品名：Baqsimi）的上市申请获NMPA批准。Baqsimi为首款上市的胰高血糖素鼻喷剂，通过患者鼻粘膜被动吸收，无需患者进行吸气配合；同时，给药者无需掌握专业技术，在30秒内即可完成给药，成功率高达90%以上。2019年，Baqsimi获FDA 批准用于4 岁及以上糖尿病患者严重低血糖的治疗，对于糖尿病患者，严重低血糖若没有得到及时治疗可能导致意识丧失，癫痫发作，昏迷、甚至死亡。2023年4月，礼来宣布将Baqsimi的全球权益出售给Amphastar，总交易金额10.75亿美元。 该药物治疗严重低血糖的疗效和安全性在两项分别包含83和70名成年胰岛素患者的临床研究中得到验证。患者在出现胰岛素引发的低血糖之后，接受一剂Baqsimi，或者一剂胰高血糖素注射，试验结果表明，Baqsimi能够有效提高血糖水平。此外，在一项包含48名4岁以上1型糖尿病患者的儿科研究中，Baqsimi表现出类似的效果。       2、兴盟生物：泽美洛韦玛佐瑞韦单抗注射液 作用机制：抗rabies virus单抗 适应症：狂犬病 6月12日，兴盟生物的泽美洛韦玛佐瑞韦单抗注射液（商品名：克瑞毕®）的上市申请获NMPA批准。该药物由泽美洛韦和玛佐瑞韦等量混合而成，两种单抗结合表位不连续、不重叠，具有不同的抗原位点独特互补的优势，有效拓宽了中和病毒谱广度。克瑞毕®具有双靶点、更广谱、起效快、早保护以及易推注、反应轻等临床优势，是国内首个符合世界卫生组织（WHO）推荐的抗狂犬病鸡尾酒抗体。研究结果显示，克瑞毕®能够迅速提升受试者体内的狂犬病病毒中和抗体水平，且安全性良好，不良反应发生率显著低于对照组；此外，同时使用狂犬病疫苗和克瑞毕®不会影响疫苗接种后狂犬疫苗中和抗体的产生，且在接种狂犬病疫苗到疫苗诱导抗体产生的“空窗期”内，使用克瑞毕®后能够更高、更快达到人体血清保护滴度。此前，该药物已被FDA授予“孤儿药”资格。       3、协和麒麟：依伏卡塞片 作用机制：钙敏感受体激动剂 适应症：甲状旁腺功能亢进 6月12日，协和麒麟的依伏卡塞片的上市申请获NMPA批准。依伏卡塞（evocalcet）属于一种新型拟钙剂，不仅可以有效降低甲状旁腺激素、血钙及FGF23，并通过抑制骨溶出来降低血磷；同时，它在药物的生物利用度上有了明显的改善，并大大减低了胃肠道副作用及与其它药物的相互作用。该药物已于2018年在日本上市，用于继发性甲状旁腺功能亢进症。一项在日本开展的单中心纵向研究结果表明，evocalcet可显著降低腹透继发性甲状旁腺功能亢进症患者的全段甲状旁腺素（iPTH）水平，受试者第16周iPTH较基线显著降低（346pg/ml vs 258pg/ml），并保持至32周；同时，试验中患者胃肠道不良反应显著降低。甲状旁腺功能亢进症（SHPT）是矿物质代谢紊乱(MBD)的重要表现类型之一，也是慢性肾脏病(CKD)患者常见且严重的并发症之一，在CKD-MBD 患者中的转化率接近50%。根据中华医学会肾脏病学分会数据显示，2017 年中国终末期肾病患者数量约290 万人，透析率只有20%多，而透析率在发达国家为90%，未来国内SHPT 的人数将逐渐增加，产品市场潜力大。       4、诺华：盐酸卡马替尼片 作用机制：MET受体酪氨酸激酶抑制剂 适应症：非小细胞肺癌 6月13日，诺华的盐酸卡马替尼片的上市申请获NMPA批准。卡马替尼（Capmatinib）是一种强效、口服、选择性、ATP竞争性的c-Met激酶抑制剂，对c-Met具有高度选择性，能有效抑制c-Met依赖性肿瘤细胞的增殖和迁移，有效诱导细胞凋亡，具有抗肿瘤活性。该药物此前在美国、日本、欧盟、瑞士、巴西、新加坡等地区获批上市，用于METex14外显子跳突非小细胞肺癌全线治疗。 该药物在中国的获批主要基于全球多中心临床研究GeoMETry mono-1及针对中国人群的注册临床研究GeoMETry-C。GeoMETry mono-1在一项治疗METex14跳跃突变的晚期非小细胞肺癌初治患者开展的前瞻性、开放标签、多队列的II期临床研究，经独立评审委员会评估后的客观缓解率（ORR）分别为：经治患者ORR为41%，初治患者为68%；中位反应持续时间分别为9.7个月和12.6个月；中位PFS分别为5.4个月和12.4个月。GeoMETry-C是一项一线治疗METex14跳突晚期非小细胞肺癌患者的研究，盲态独立审查委员会和研究者评估的ORR分别为53.3%和60%，且在中国患者重点整体不良反应发生率与全球人群相似。       全球新药III期临床汇总 封面图来源：123rf 版权声明/免责声明 本文为授权转载文章。 本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。 文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。 如有任何问题，请与我们联系。 衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn MNC新药管线大比武！罗氏蝉联榜首，辉瑞第二，恒瑞首次上榜，排名第八 CAR-T黑框警告，再起波澜 艾伯维又一款 ADC 强势来袭，已被CDE纳入突破性治疗品种名单...... 点击这里，发现价值信息！

Conference Call and Webcast at 8:30 a.m. Eastern Time Today SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Inc. (Nasdaq: LGND) today reported financial results for the three and twelve months ended December 31, 2023, and provided an operating forecast and business updates. Ligand management will host a conference call and webcast today beginning at 8:30 a.m. Eastern time to discuss this announcement and answer questions. “2023 was a transformative year for Ligand, both operationally and financially. We refocused the company to be a lean-infrastructure, high-margin business,” said Todd Davis, CEO of Ligand. “We enhanced our deal making capabilities with the strengthening of our senior team and opening of a Boston office. These initiatives will help us execute on a larger scale and continue to expand our portfolio through a focus on life science royalty opportunities. We are now well positioned and resourced to close on multiple new investments. We also saw important clinical and regulatory events across our existing partnered assets and expect this momentum will continue in 2024 and beyond.” Fourth Quarter 2023 Financial Results Total revenues for the fourth quarter of 2023 were $28.1 million. Revenues for the same period in 2022 excluding sales related to COVID-19 were to $26.8 million. Total revenues for the fourth quarter of 2022 including COVID-19 related sales were $50.4 million. Royalties for the fourth quarter of 2023 were $22.5 million, compared with $22.0 million for the same period in 2022. Core Captisol® sales (excluding sales of Captisol related to COVID-19) were $3.9 million for the fourth quarter of 2023, compared with $3.3 million for the same period in 2022. There were no Captisol sales related to treatments for COVID-19 for the fourth quarter of 2023, compared with $23.5 million for the same period in 2022. Contract revenue was $1.7 million for the fourth quarter of 2023, compared with $1.5 million for the same period in 2022, with the difference due to the timing of partner milestone events. Costs of Captisol sales were $1.6 million for the fourth quarter of 2023, compared with $21.6 million for the same period in 2022, with the decrease due to lower total Captisol sales during the fourth quarter of 2023 and $9.8 million in accelerated depreciation on Captisol manufacturing equipment during the fourth quarter of 2022. Amortization of intangibles was $8.3 million for the fourth quarter of 2023, compared with $8.5 million for the same period in 2022. Research and development expenses were $5.5 million for the fourth quarter of 2023, compared with $9.2 million for the same period in 2022, with the decrease attributed to lower stock-based compensation, employee related expenses and lab supply expenses. General and administrative expenses were $16.0 million for the fourth quarter of 2023, compared with $31.1 million for the same period in 2022, with the decrease primarily attributed to lower stock-based compensation and employee related expenses for the fourth quarter of 2023 and a one-time stock compensation expense associated with the retirement of our former CEO in the fourth quarter of 2022. Net income from continuing operations for the fourth quarter of 2023 was $18.2 million, or $1.03 per diluted share, compared to a net loss of $14.5 million, or $0.86 per share, for the same period in 2022. Net income from continuing operations for the fourth quarter of 2023 included a $16.0 million gain in short term investment primarily driven by an increase in the value of our holdings in Viking Therapeutics (Nasdaq: VKTX) stock. The net loss for the fourth quarter of 2022 was impacted by the aforementioned Captisol equipment accelerated depreciation, a one-time stock compensation expense and a $24.8 million deferred tax asset valuation allowance during the fourth quarter of 2022, which was partially offset by a non-cash gain of $44.2 million from the value of Ligand's short-term investments. Adjusted net income from continuing operations for the fourth quarter of 2023 was $24.4 million, or $1.38 per diluted share, compared to $23.5 million, or $1.36 per diluted share, for the same period in 2022. Excluding the impact of gains from sales of Viking Therapeutics stock and gross profit from Captisol sales related to COVID-19, core adjusted net income for the fourth quarter of 2023 was $18.6 million, or $1.05 per diluted share, compared with $13.0 million, or $0.75 per diluted share, for the same period in 2022. The table below shows a reconciliation of net income (loss) from continuing operations to adjusted net income from continuing operations. As of December 31, 2023, Ligand had cash, cash equivalents and short-term investments of $170.3 million. Full Year 2023 Financial Results Total revenues for 2023 were $131.3 million. Revenues for 2022, excluding Captisol sales related to COVID-19, were $108.2 million. Total revenues for 2022 including COVID-19 related sales were $196.2 million. Royalties for 2023 were $83.9 million, compared with $72.5 million for 2022, with the increase primarily attributable to the increase in sales of Kyprolis®, Rylaze®, Vaxneuvance™ and Pneumosil®. Core Captisol sales were $28.4 million for 2023, compared with $16.4 million for 2022. The difference in sales was due to the timing of customer orders. There were no Captisol sales related to COVID-19 in 2023, compared with $88.1 million in 2022. Contract revenue for 2023 was $19.0 million, compared to $19.2 million for 2022. Cost of Captisol sales were $10.5 million for 2023, compared to $52.8 million for 2022, with the decrease due to lower total sales of Captisol during 2023 and $9.8 million in accelerated depreciation on Captisol manufacturing equipment during 2022. Amortization of intangibles was $33.7 million for 2023, compared with $34.2 million for 2022. Research and development expenses were $24.5 million for 2023, compared with $36.1 million for 2022, with the decrease primarily attributed to lower share-based compensation and employee-related expenses, partially offset by an increase in R&D expenses due to the Novan acquisition. General and administrative expenses were $52.8 million for 2023, compared with $70.1 million for 2022, with the decrease primarily attributable to decreases in share-based compensation expenses including a one-time charge associated with the retirement of our former CEO in the fourth quarter of 2022, and employee-related expenses. In September 2023, Ligand spun out its Pelican subsidiary through a merger with Primordial Genetics, to form a privately held company, Primrose Bio, which resulted in a gain on the sale of Pelican in the amount of $2.1 million for 2023. Net income from continuing operations for 2023 was $53.8 million, or $3.03 per diluted share, compared to a net loss from continuing operations of $5.2 million, or $0.31 per share for 2022. The increase in net income from the prior year is due primarily to the aforementioned Captisol equipment accelerated depreciation in 2022, a one-time stock compensation expense and a $24.8 million deferred tax asset valuation allowance during 2022; partially offset by an increase in gain from short-term investments which increased to $46.4 million in 2023 from $28.5 million in 2022. Adjusted net income from continuing operations for 2023 was $107.4 million or $6.09 per diluted share, compared with $82.2 million, or $4.79 per diluted share for 2022. Excluding the impact of gains from sales of Viking Therapeutics stock and gross profit from Captisol sales related to COVID-19, core adjusted net income for 2023 was $71.7 million, or $4.06 per diluted share, compared with $41.9 million, or $2.44 per diluted share, for 2022. The table below shows a reconciliation of net income (loss) from continuing operations to adjusted net income from continuing operations. 2024 Financial Guidance Ligand is reaffirming 2024 financial guidance introduced at its Investor and Analyst Day held on December 12, 2023. The Company expects 2024 royalties ranging from $90 million to $95 million, sales of Captisol ranging from $25 million to $27 million and contract revenue ranging from $15 million to $20 million. These revenue components result in total revenue forecast of $130 million to $142 million. Ligand notes that with total revenue of $130 million to $142 million, adjusted earnings per diluted share are expected to range from approximately $4.25 to $4.75. Fourth Quarter 2023 and Recent Business Highlights On January 5, 2024, the U.S. Food and Drug Administration (FDA) approved ZELSUVMI™ (berdazimer topical gel, 10.3%) as a first-in-class medication for the treatment of molluscum contagiosum in adults and pediatric patients one year of age or older. Ligand acquired ZELSUVMI through its acquisition of assets from Novan, along with other assets. ZELSUVMI is the first and only topical prescription medication that can be applied by patients, parents, or caregivers at home to treat this highly contagious viral skin infection. Merck (NYSE: MRK) announced the FDA accepted for priority review a new BLA for V116, its investigational 21-valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumonia in adults. The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 17, 2024. If approved, Ligand is entitled to a low single digit royalty on worldwide net sales. Sermonix Pharmaceuticals (private) announced it entered into a strategic collaboration and exclusive license agreement with Henlius for the rights to develop, manufacture and commercialize Sermonix's lead investigational drug, lasofoxifene, in China. Under the terms of the agreement, Henlius will receive exclusive rights and sublicenses to lasofoxifene for at least two estrogen receptor-positive (ER+)/HER2- breast cancer indications in the territory, with Sermonix retaining all other global rights. Sermonix plans to work with Henlius to accelerate the clinical development of the Phase 3 ELAINE-3 multi-regional clinical trial in China, making lasofoxifene available to Chinese patients as soon as possible. Travere Therapeutics (Nasdaq: TVTX) announced a successful pre-NDA meeting for FILSPARI® in IgA Nephropathy (IgAN). After meeting with the FDA, Travere plans to submit a supplemental New Drug Application (sNDA) in the first quarter of 2024 for conversion of the existing U.S. Accelerated Approval of FILSPARI to full approval. Travere also completed regulatory engagement on focal segmental glomerulosclerosis (FSGS) in which the FDA communicated that the Phase 3 DUPLEX study results alone are not sufficient to support an sNDA submission for an FSGS indication for FILSPARI. As a result, Travere plans to conduct additional analyses of FSGS data with plans to re-engage the FDA in 2024 and is implementing a strategic reorganization to focus near-term resources on the ongoing FILSPARI launch in IgAN. Travere also announced fourth quarter 2023 results reporting that it received 459 new patient start forms for FILSPARI in the fourth quarter of 2023 and net product sales of $14.9 million for the fourth quarter. Eisai Co., Ltd. has obtained marketing authorization approval from the Japanese Ministry of Health, Labour and Welfare for the Captisol-enabled™ injection formulation of its antiepileptic drug (AED) Fycompa® (perampanel) in Japan as an alternative therapy when oral administration is temporarily not possible. Fycompa is a first-in-class AED discovered and developed by Eisai. Aldeyra Therapeutics (Nasdaq: ALDX) announced receipt of a Complete Response Letter (CRL) from the FDA for the NDA of reproxalap, an investigational drug candidate, for the treatment of dry eye disease. The potential NDA resubmission is anticipated in the first half of 2024, pending FDA special protocol assessment (SPA) feedback and positive results from the proposed trial. Aldeyra intends to include in the potential NDA resubmission a draft label describing chronic and acute symptomatic benefit, in addition to acute reduction in ocular redness of reproxalap. The review period for the potential NDA resubmission is expected to be six months. Palvella Therapeutics (private) announced that the FDA has granted Breakthrough Therapy Designation to QTORIN rapamycin™ for the treatment of microcystic lymphatic malformations (Microcystic LMs). Microcystic LMs is a chronically debilitating and lifelong genetic disease affecting an estimated more than 30,000 patients in the U.S. There are currently no FDA-approved treatments for Microcystic LMs. In November, Viking Therapeutics, Inc. (Nasdaq: VKTX) announced the presentation of new results from the ongoing Phase 2b clinical trial of VK2809, a novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). The latest findings from the VOYAGE study were featured in a late breaking poster presentation at the Liver Meeting® 2023, the annual meeting of the American Association for the Study of Liver Diseases (AASLD). The newly reported findings demonstrated robust and comparable liver fat reductions among patients with or without Type 2 diabetes, as well as patients with either F2 or F3 fibrosis. Verona Pharma (Nasdaq: VRNA) announced they have entered into a debt financing facility providing the company with access to up to $400 million from funds managed by Oxford Finance LLC and Hercules Capital, Inc. The debt facility provides non-dilutive capital and further financial flexibility to support Verona Pharma’s continued growth, including the planned commercial launch of ensifentrine. The debt facility replaces the existing facility of up to $150 million with an affiliate of Oxford. Adjusted Financial Measures Ligand 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 share-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, transaction costs, income tax affect of adjusted reconciling items and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included at the end of this press release. However, the Company 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, share-based compensation expense and the 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 and webcast today beginning at 8:30 a.m. Eastern time (5:30 a.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (800) 715-9871 (North America toll-free number) using the conference ID 875533. International participants outside of Canada may use the toll number (647) 932-3411 and use the same conference ID. To participate via live or replay webcast, a link is available at . About Ligand Pharmaceuticals Ligand is a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines. Ligand does this by providing financing, licensing our technologies or both. Our business model seeks to generate value for stockholders by creating 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 and diversified manner. Our business model is based on funding programs in mid- to late-stage drug development in return for economic rights and licensing our technology to help partners discover and develop medicines. We partner with other pharmaceutical companies to attempt to leverage what they do best (late-stage development, regulatory management and commercialization) in order to generate our revenue. Our Captisol® platform technology is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. We have established multiple alliances, licenses and other business relationships with the world’s leading pharmaceutical companies including Amgen, Merck, Pfizer, Jazz, Takeda, Gilead Sciences and Baxter International. For more information, please visit . Follow Ligand on X (f/k/a Twitter) @Ligand_LGND. We use our investor relations website and X as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Investors should monitor our website and our X account, in addition to following our press releases, SEC filings, public conference calls and webcasts. 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 ability to expand its portfolio with life sciences royalty opportunities; the timing of clinical and regulatory events of Ligand’s partners; the timing of the initiation or completion of preclinical studies and clinical trials by Ligand and its partners; the timing of product launches by Ligand or its partners; and guidance regarding the full-year 2024 financial results. Actual events or results may differ from Ligand's expectations due to risks and uncertainties inherent in Ligand’s business, including, without limitation: Ligand relies on collaborative partners for milestone payments, royalties, materials revenue, contract payments and other revenue projections and may not receive expected revenue; Ligand may not receive expected revenue from Captisol material sales; Ligand and its partners may not be able to timely or successfully advance any product(s) in its internal or partnered pipeline or receive regulatory approval and there may not be a market for the product(s) even if successfully developed and approved; Ligand may not achieve its guidance for 2024; Ligand faces competition in acquiring royalties and locating suitable royalties to acquire; Ligand may not be able to create future revenues and cash flows through the acquisition of royalties or by developing innovative therapeutics; products under development by Ligand or its partners may not receive regulatory approval; the total addressable market for our partners’ products may be smaller than estimated; Ligand faces competition with respect to its technology platforms which may demonstrate greater market acceptance or superiority; Ligand is currently dependent on a single source sole supplier for Captisol and failures by such supplier may result in delays or inability to meet the Captisol demands of its partners; Ligand’s partners may change their development focus and may not execute on their sales and marketing plans for marketed products for which Ligand has an economic interest; Ligand’s and its partners’ products may not be proved to be safe and efficacious and may not perform as expected and uncertainty regarding the commercial performance of such products; Ligand or its partners may not be able to protect their intellectual property and patents covering certain products and technologies may be challenged or invalidated; Ligand's partners may terminate any of its agreements or development or commercialization of any of its products; 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, challenges, costs and charges associated with integrating acquisitions with Ligand’s existing businesses; Ligand may not be able to successfully commercialize Novan's berdazimer program and may not be able to outlicense or sell Novan's programs or assets; Ligand may not be able to successfully implement its strategic growth plan and continue the development of its proprietary programs; restrictions under Ligand's credit agreement may limit its flexibility in operating its business and a default under the agreement could result in a foreclosure of the collateral securing such obligations; changes in general economic conditions, including as a result of war, conflict or epidemic diseases and ongoing or future litigation could expose Ligand to significant liabilities and have a material adverse effect on the company. 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 as well as in Ligand's public periodic filings with the Securities and Exchange Commission available at . Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release, including the possibility of additional license fees and milestone revenues we may receive. 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 V116, a Merck product candidate, FILSPARI, a Travere Therapeutics product, Fycompa, an Eisai Co. Ltd., product, reproxalap, an Aldeyra Therapeutics product candidate, and QTORIN, a Palvella Therapeutics product candidate, 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 ZELSUVMI, a Novan product. Solely for convenience, some of the trademarks and copyrights referred to in this press release are listed without the ®, © and ™ 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, except per share amounts) Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Revenues: Royalties $ 22,463 $ 22,019 $ 83,910 $ 72,527 Captisol - Core 3,922 3,347 28,372 16,429 Captisol - COVID — 23,533 — 88,066 Contract revenue 1,716 1,483 19,032 19,223 Total revenues 28,101 50,382 131,314 196,245 Operating costs and expenses: Cost of Captisol 1,641 21,614 10,512 52,827 Amortization of intangibles 8,338 8,539 33,654 34,237 Research and development 5,488 9,197 24,537 36,082 General and administrative 15,992 31,131 52,790 70,062 Total operating costs and expenses 31,459 70,481 121,493 193,208 Gain on sale of Pelican — — (2,121 ) — (Loss) income from operations (3,358 ) (20,099 ) 11,942 3,037 Gain from short-term investments 16,025 44,248 46,365 28,540 Interest income, net 1,562 783 7,055 247 Gain on derivative instruments 250 — 250 — Other income (expense), net 2,618 (792 ) (1,952 ) 4,187 Total other income, net 20,455 44,239 51,718 32,974 Income before income taxes 17,097 24,140 63,660 36,011 Income tax benefit (expense) 1,091 (38,674 ) (9,841 ) (41,230 ) Net income (loss) from continuing operations 18,188 (14,534 ) 53,819 (5,219 ) Net loss from discontinued operations — (2,951 ) (1,665 ) (28,142 ) Net income (loss): $ 18,188 $ (17,485 ) $ 52,154 $ (33,361 ) Basic net income (loss) from continuing operations per share $ 1.04 $ (0.86 ) $ 3.11 $ (0.31 ) Basic net loss from discontinued operations per share $ — $ (0.17 ) $ (0.10 ) $ (1.67 ) Basic net income (loss) per share $ 1.04 $ (1.04 ) $ 3.02 $ (1.98 ) Shares used in basic per share calculation 17,466 16,890 17,298 16,868 Diluted net income (loss) from continuing operations per share $ 1.03 $ (0.86 ) $ 3.03 $ (0.31 ) Diluted net loss from discontinued operations per share $ — $ (0.17 ) $ (0.09 ) $ (1.67 ) Diluted net income (loss) per share $ 1.03 $ (1.04 ) $ 2.94 $ (1.98 ) Shares used in diluted per share calculation 17,676 16,890 17,757 16,868 LIGAND PHARMACEUTICALS INCORPORATED CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in thousands) December 31, 2023 December 31, 2022 Assets Current assets: Cash and cash equivalents $ 22,954 $ 45,006 Short-term investments 147,355 166,864 Accounts receivable, net 32,917 30,424 Inventory 23,969 13,294 Income tax receivable 6,395 4,614 Prepaid expenses 1,182 1,132 Other current assets 2,657 2,267 Total current assets 237,429 263,601 Deferred income taxes, net 46,062 8,530 Goodwill and other identifiable intangible assets, net 402,976 448,128 Commercial license and other economic rights, net 67,291 10,182 Operating lease right-of-use assets 6,062 10,914 Finance lease 3,393 4,095 Equity method investment in Primrose Bio 12,595 — Other investments 35,726 3,000 Other assets 21,530 14,218 Total assets $ 833,064 $ 762,668 Liabilities and Stockholders' Equity Current liabilities: Accounts payable and accrued liabilities $ 14,894 $ 20,988 Current contingent liabilities 256 57 Current operating lease liabilities 403 670 Current finance lease liabilities 7 45 Deferred revenue 1,222 355 2023 convertible senior notes, net — 76,695 Total current liabilities 16,782 98,810 Long-term contingent liabilities 2,942 3,456 Long-term operating lease liabilities 5,755 10,336 Long-term deferred revenue 1,444 44 Deferred income taxes, net 77,470 30,615 Other long-term liabilities 27,758 21,922 Total liabilities 132,151 165,183 Total stockholders' equity 700,913 597,485 Total liabilities and stockholders' equity $ 833,064 $ 762,668 LIGAND PHARMACEUTICALS INCORPORATED ADJUSTED FINANCIAL MEASURES (Unaudited, in thousands, except per share amounts) Three months ended December 31, Year ended December 31, 2023 2022 2023 2022 Net income (loss) from continuing operations $ 18,188 $ (14,534 ) $ 53,819 $ (5,219 ) Adjustments: Share-based compensation expense 5,721 27,664 25,743 50,881 Finance lease impairment charge and other — 10,821 — 10,821 Non-cash interest expense (1) 81 95 240 734 Amortization related to acquisitions and intangible assets 8,338 8,539 33,654 34,237 Amortization of commercial license and other economic rights (2) (23 ) (32 ) (1,049 ) (355 ) Change in contingent liabilities (3) (397 ) 698 (265 ) (144 ) Novan operating loss 5,183 — 5,520 — Transaction costs (210 ) — 3,078 — Gain from short-term investments (16,025 ) (44,248 ) (46,365 ) (28,540 ) Realized gain (loss) from short-term investments 7,180 — 44,377 (288 ) Gain on sale of Pelican — — (2,121 ) — Credit losses and impairment charges for commercial license rights 405 — 4,519 — Loss from equity method investment in Primrose Bio 1,761 1,829 Other (4) (156 ) 1,904 530 (34 ) Income tax effect of adjusted reconciling items above 816 8,093 (9,144 ) (4,561 ) Tax benefit related to decrease in unrecognized tax benefits (5) (7,206 ) — (7,206 ) — Tax expense related to increase in valuation allowance (6) — 24,799 — 24,799 Excess tax benefit (shortfall) from share-based compensation (7) 757 (267 ) 228 (138 ) Adjusted net income from continuing operations $ 24,413 $ 23,532 $ 107,387 $ 82,193 Realized gains from sales of VKTX stock, net of tax (5,780 ) — (35,720 ) — Captisol - COVID gross profit, net of tax (8) — (10,514 ) — (40,268 ) Core adjusted net income from continuing operations $ 18,633 $ 13,018 $ 71,667 $ 41,925 Diluted per-share amounts attributable to common shareholders: Diluted net income (loss) per share from continuing operations $ 1.03 $ (0.86 ) $ 3.03 $ (0.31 ) Adjustments: Share-based compensation expense 0.32 1.60 1.46 2.96 Finance lease impairment charge and other — 0.63 — 0.63 Non-cash interest expense (1) — 0.01 0.01 0.04 Amortization related to acquisitions and intangible assets 0.47 0.49 1.91 1.99 Amortization of commercial license and other economic rights (2) — — (0.06 ) (0.02 ) Change in contingent liabilities (3) (0.02 ) 0.04 (0.02 ) (0.01 ) Novan operating loss 0.29 0.31 Transaction costs (0.01 ) — 0.17 — Loss (gain) from short-term investments (0.91 ) (2.56 ) (2.63 ) (1.66 ) Realized gain from short-term investments 0.41 — 2.52 (0.02 ) Gain on sale of Pelican — — (0.12 ) — Credit losses and impairment charges for commercial license rights 0.02 — 0.26 — Loss from equity method investment in Primrose Bio 0.10 — 0.10 — Other (4) — 0.10 0.04 0.01 Income tax effect of adjusted reconciling items above 0.05 0.48 (0.49 ) (0.27 ) Tax benefit related to decrease in unrecognized tax benefits (5) (0.41 ) — (0.41 ) — Tax expense related to increase in valuation allowance (6) — 1.44 — 1.44 Excess tax benefit (shortfall) from share-based compensation (7) 0.04 (0.02 ) 0.01 (0.01 ) Adjustment for shares excluded due to anti-dilution effect on GAAP net loss — 0.01 — 0.02 Adjusted diluted net income per share from continuing operations $ 1.38 $ 1.36 $ 6.09 $ 4.79 Realized gains from sales of VKTX stock, net of tax (0.33 ) — (2.03 ) — Captisol - COVID gross profit, net of tax (8) — (0.61 ) — (2.35 ) Core adjusted diluted net income per share from continuing operations $ 1.05 $ 0.75 $ 4.06 $ 2.44 GAAP - weighted average number of common shares - diluted 17,676 16,890 17,757 16,868 Shares excluded due to anti-dilutive effect on GAAP net loss — 390 — 298 Diluted effect of the 2023 Notes (9) — — (119 ) — Adjusted weighted average number of common shares - diluted 17,676 17,280 17,638 17,166 (1) Amounts represent non-cash debt related costs that are calculated in accordance with the authoritative accounting guidance for convertible debt instruments that may be settled in cash and for revolving credit facility. (2) Amounts represent the amortization of commercial license and other economic rights to revenue. (3) Amounts represent changes in fair value of contingent consideration related to CyDex and Metabasis transactions. (4) Amounts primarily relate to restructuring costs, losses associated with our equity investment in Nucorion, gain or loss from change in fair value or derivative assets as well as gain on debt extinguishment in the prior year period. (5) Amounts represent discrete tax benefit related to the release of FIN48 reserves associated with certain R&D tax credits during the fourth quarter of 2023 due to the lapse of applicable statute of limitation. (6) Amounts represent discrete tax expense related to the valuation allowance established during the fourth quarter of 2022 against deferred tax asset for California research and development credits and net operating losses. (7) Excess tax benefits from share-based compensation are recorded as a discrete item within the provision for income taxes on the consolidated statements of operations as a result of the adoption of an accounting pronouncement (ASU 2016-09) on January 1, 2017. Prior to the adoption, the amount was recognized in additional paid-in capital on the consolidated statement of stockholders' equity. (8) Captisol - COVID gross profit, net of tax, represents gross profit, net of tax, for Captisol supplied for use in formulation with remdesivir, an antiviral treatment for COVID-19. (9) Excluding the impact from the adoption of accounting pronouncement (ASU 2020-06) on January 1, 2022, as the Company has intended to settle the principal balance in cash. Under the standard, the Company is required to reflect the dilutive effect of the 2023 Notes by application of the if-converted method, The 2023 Notes were fully paid off on May 15, 2023, the debt maturity date.

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 six months ended June 30, 2023, and provided an operating forecast and business updates. Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time to discuss this announcement and answer questions. “We are pleased to report continued momentum across our portfolio of partnered assets, with multiple positive developments for our commercial and pipeline products,” said Todd Davis, CEO of Ligand. “Ligand has a strong balance sheet with $219 million in cash, and, after a recent paydown of convertible notes, we are debt free with positive cash flows that can also be deployed. We are well positioned to make additional investments, that, paired with our enhanced deal skillset and expanded team, are expected to add robust programs and diversity to our product pipeline.” Second Quarter 2023 Financial Results Total revenues for the second quarter of 2023 were $26.4 million. Revenues for the same period in 2022 excluding sales related to COVID-19 were $23.9 million. Total revenues for the second quarter of 2022 including COVID-19 related sales were $50.1 million. Royalties for the second quarter of 2023 were $20.4 million, compared with $17.8 million for the same period in 2022, with the increase primarily attributable to Kyprolis, Rylaze and Vaxneuvance. Core Captisol sales were $5.2 million for the second quarter of 2023, compared with $3.3 million for the same period in 2022. The increase in sales was due to the timing of customer orders. There were no Captisol sales related to COVID-19 for the second quarter of 2023, compared with $26.2 million for the same period in 2022. Contract revenue was $0.7 million for the second quarter of 2023, compared with $2.8 million for the same period in 2022. The difference was due to the timing of partner milestone events. Cost of Captisol was $1.7 million for the second quarter of 2023, compared with $12.4 million for the same period in 2022, with the decrease due to lower total Captisol sales. Amortization of intangibles was $8.5 million, compared with $8.6 million for the same period in 2022. Research and development expense was $6.9 million, compared with $8.5 million for the same period in 2022, with the decrease attributed to lower stock based compensation, employee related expenses and lab supply expenses. General and administrative expense was $11.3 million, compared with $12.1 million for the same period in 2022, with the decrease primarily attributable to lower legal expenses. Net income from continuing operations for the second quarter of 2023 was $2.3 million, or $0.13 per diluted share, compared with net income from continuing operations of $12.6 million, or $0.74 per share, for the same period in 2022. The decrease in net income from the prior year period is due primarily to the decrease in COVID-19 related sales offset by increases in royalty revenue, gain from short term investments and interest income. Adjusted net income from continuing operations for the second quarter of 2023 was $25.1 million, or $1.42 per diluted share, compared with $7.4 million, or $0.43 per diluted share, for the same period in 2022 which excluded the impact of gross profit, net of tax, for Captisol sales related to COVID-19. See the table below for a reconciliation of net income from continuing operations to adjusted net income from continuing operations. On May 15, 2023, the 2023 Notes maturity date, we paid off the remaining balance of the convertible notes in amount of $77.1 million (including interest). As of June 30, 2023, Ligand had cash, cash equivalents and short-term investments of $219.0 million. Also in Q2, Ligand put in place a $50 million share repurchase program that expires in April 2026. The timing and amount of repurchase transactions, if any, will be determined by the Company’s management based on its evaluation of market conditions, share price, legal requirements and other factors. Year-to-Date Financial Results Total revenues for the six months ended June 30, 2023 were $70.3 million. Revenues for the same period in 2022 excluding sales related to COVID-19 were $54.5 million. Revenues for the six months ended June 30, 2022 including COVID-19 related sales were $86.6 million. Royalties for the six months ended June 30, 2023 were $37.6 million, compared with $31.3 million for the same period in 2022, with the increase primarily attributable to Kyprolis and the growth in sales of drugs using the Pelican platform. Core Captisol sales were $15.8 million for the six months ended June 30, 2023, compared with $9.6 million for the same period in 2022. The difference in sales was due to the timing of customer orders. There were no Captisol sales related to COVID-19 for the six months ended June 30, 2023, compared with $32.1 million for the same period in 2022. Contract revenue was $16.9 million for the six months ended June 30, 2023, compared with $13.7 million for the same period in 2022. The difference was due to the timing of partner milestone events. Cost of Captisol was $5.4 million for the six months ended June 30, 2023, compared with $17.1 million for the same period in 2022, with the decrease due to lower total Captisol sales. Amortization of intangibles was $17.1 million for both the six months ended June 30, 2023 and 2022. Research and development expense for the six months ended June 30, 2023 was $13.5 million, compared with $17.6 million for the same period in 2022, with the decrease attributed to lower employee related expenses and lab supply expenses. General and administrative expense for the six months ended June 30, 2023 was $22.1 million, compared with $24.0 million for the same period in 2022, with the decrease primarily attributable to lower legal expenses. Net income from continuing operations for the six months ended June 30, 2023 was $45.9 million, or $2.57 per diluted share, compared with net loss from continuing operations of $0.3 million, or $0.02 per share, for the same period in 2022. The increase in net income was driven by a gain from short term investments of $43.5 million in the current year period and a loss from short term investments of $14.8 million for the same period in 2022. Adjusted net income from continuing operations for the six months ended June 30, 2023 was $65.0 million, or $3.69 per diluted share, compared with $18.4 million, or $1.07 per diluted share, for the same period in 2022 which excluded the impact of gross profit, net of tax, for Captisol sales related to COVID-19. See the table below for a reconciliation of net income (loss) from continuing operations to adjusted net income from continuing operations. 2023 Financial Guidance Ligand is reaffirming its 2023 revenue guidance of $124 million to $128 million and raising adjusted EPS guidance. Guidance for royalties is unchanged at $78 million to $82 million. Sales of Captisol are now expected to be $24 million (previously $21 million) and contract revenue is now expected to be $22 million (previously $25 million). We now expect 2023 adjusted diluted EPS of $4.85 to $5.00 (previously $4.60 to $4.75). The increase in EPS guidance is driven primarily by additional gains realized from the sale of Viking Therapeutics securities. Due to the unpredictable nature of the pandemic and related Captisol sales, Ligand excludes Captisol sales related to COVID-19 from guidance and will update investors as orders are received and shipped each quarter. Second Quarter 2023 and Recent Business Highlights On July 14, 2023 Ligand made a $3 million bridge loan to Novan, Inc. (Nasdaq: NOVN) in contemplation of Novan filing for bankruptcy relief. On July 17th Novan filed for bankruptcy relief and Ligand entered into an agreement with Novan to purchase its assets for $15 million in cash and provide them up to $15 million in debtor-in-possession financing, inclusive of the $3 million bridge loan. The purchase is subject to approval by the bankruptcy court. Novan’s assets include Berdazimer gel, which is in development for molluscum contagiosum infection, and has an NDA with the FDA and an assigned PDUFA goal date of January 5, 2024. If the purchase agreement is approved, and Ligand’s bid is successful in the anticipated bankruptcy sale and auction process, Ligand will acquire the Novan assets and consistent with Ligand’s business model, will seek to outlicense or sell the existing development programs and commercial business assets of Novan. On July 17, 2023 Travere Therapeutics (Nasdaq: TVTX) announced that 417 new patient start forms (PSFs) were received in the second quarter and a total of 563 PSFs have been received since the accelerated approval of FILSPARI was obtained in the first quarter of 2023. Travere also announced the sale of its bile acid product portfolio to Mirum Pharmaceuticals for $210 million upfront and up to $235 million in additional sales based milestones. The sale enables Travere to further focus its efforts on the ongoing launch of FILSPARI for IgA nephropathy and pursing a potential regulatory path forward in FSGS. Viking Therapeutics, Inc. (Nasdaq: VKTX) announced its Phase 2b clinical trial of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) achieved its primary endpoint, with patients receiving VK2809 experiencing statistically significant reductions in liver fat content from baseline to Week 12 as compared with placebo. The median relative change from baseline in liver fat as assessed by magnetic resonance imaging, proton density fat fraction (MRI-PDFF) ranged from 38% to 55% for patients receiving VK2809. Additionally, VK2809-treated patients demonstrated statistically significant reductions in low-density lipoprotein cholesterol (LDL-C), triglycerides, and atherogenic lipoproteins compared with placebo. Merck (NYSE: MRK) announced its Phase 3 clinical trial of V116, an investigational 21-valent pneumococcal conjugate vaccine, met key immunogenicity and safety endpoints in two Phase 3 trials. If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults. Results from the STRIDE-3 trial demonstrated statistically significant immune responses compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in vaccine-naïve adults for serotypes common to both vaccines. Positive immune responses were also observed for serotypes unique to V116. Additionally, results from STRIDE-6 demonstrated that V116 was immunogenic for all 21 pneumococcal serotypes in the vaccine among adults who previously received a pneumococcal vaccine at least one year prior to the study. In both studies, V116 had a safety pro to the comparator in the studies. Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the European Commission marketing authorization of JZP458 (approved as Rylaze in the U.S.) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase. Verona Pharma Plc (Nasdaq: VRNA) submitted an NDA to the FDA for approval of ensifentrine for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Verona also published results from its Phase 3 ENHANCE trials in the American Journal of Respiratory and Critical Care Medicine demonstrating improvements in lung function, symptoms and quality of life measures, a substantial reduction in the rate and risk of COPD exacerbations and a favorable safety profile. Palvella Therapeutics announced a planned pivotal Phase 3 study design of QTORIN rapamycin for the treatment of Microcystic Lymphatic Malformations, following previously announced positive Phase 2 results. Additionally, Palvella announced QTORIN rapamycin did not show a treatment effect when compared to placebo in the pivotal Phase 3 trial in Pachyonychia Congenita and will no longer continue development in that indication. Gilead Sciences, Inc. (Nasdaq: GILD) received FDA approval of Veklury (remdesivir) for COVID-19 treatment in patients with severe renal impairment, including those on dialysis. With this approval, Veklury is now the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease. The U.S. approval follows the European Commission decision to extend the approved use of Veklury to treat COVID-19 in people with severe renal impairment, including those on dialysis. Xintong Pharmaceuticals made an NDA submission of pradefovir for hepatitis B virus (HBV) in China and received Priority Review. Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) announced positive top-line results from its Phase 3 clinical trial of reproxalap in patients with allergic conjunctivitis. The clinical trial successfully achieved statistical significance for the primary and all secondary endpoints. Adjusted Financial Measures Ligand 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 share-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, income tax affect of adjusted reconciling items and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included at the end of this press release. However, the Company 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, share-based compensation expense and the 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 (888) 350-3452 using the conference ID 6501694. Callers outside the U.S. may dial 1 (646) 960-0369. To participate via live or replay webcast, a link is available at . About Ligand Pharmaceuticals Ligand is a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines. Ligand does this by providing financing, licensing our platform technologies or both. Our business model generates value for stockholders by creating 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 and diversified manner. Our business model is based on funding mid to late-stage drug development in return for economic rights and licensing our technology platforms to help partners discover and develop medicines. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) to generate our revenue. We have two primary platform technologies that are available for outlicense – Captisol and Pelican. Our Captisol platform technology is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. For our Captisol partners, our team supplies the Captisol material needed for their programs. Our Pelican Expression Technology is a robust, validated, cost-effective and scalable platform for recombinant protein production that is especially well-suited for complex, large-scale protein production where traditional systems are not. We have established multiple alliances, licenses and other business relationships with the world’s leading pharmaceutical companies including Amgen, Merck, Pfizer, Jazz, Takeda, Gilead Sciences and Baxter International. For more information, please visit . 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, University Distinguished Professor 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 Gilead Sciences' VEKLURY®, Amgen’s KYPROLIS®, Baxter International’s NEXTERONE®, Acrotech Biopharma L.L.C.’s and CASI Pharmaceuticals’ EVOMELA®, Melinta Therapeutics’ BAXDELA™ and Sage Therapeutics’ ZULRESSO™. There are many Captisol-enabled products currently in various stages of development. Ligand maintains a broad global patent portfolio for Captisol with approximately 390 issued patents worldwide relating to the technology (including over 40 in the U.S.) and with the latest expiration date in 2033. Other patent applications covering methods of making Captisol, if issued, extend to 2040. About the Pelican Expression Technology™ Platform Pelican is a validated, cost-effective and scalable platform for recombinant protein production that is especially well-suited for complex, large-scale protein production where traditional systems are not. Multiple global manufacturers have demonstrated consistent success with the platform and the technology is currently out-licensed for numerous commercial and development-stage programs. The versatility of the platform has been demonstrated in the production of enzymes, peptides, antibody derivatives and engineered non-natural proteins. Partners seek the platform as it can contribute significant value to biopharmaceutical development programs by reducing development timelines and costs for manufacturing therapeutics and vaccines. Given pharmaceutical industry trends toward large molecules with increasing structural complexities, Pelican is well positioned to meet these growing needs as one of the most comprehensive broadly available protein production platforms in the industry. Follow Ligand on Twitter @Ligand_LGND. We use Twitter and our investor relations website as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Investors should monitor our Twitter account and our website, in addition to following our press releases, SEC filings, public conference calls and webcasts. 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: the potential to acquire Novan's assets and outlicense or sell its programs and assets; the ability for Travere to focus its efforts on the launch of FILSPARI and pursuing a potential regulatory path forward in FSGS; the timing of clinical and regulatory events of Ligand’s partners; the expansion and diversity of Ligand’s portfolio; and guidance regarding the full-year 2023 financial results. Actual events or results may differ from Ligand's expectations due to risks and uncertainties inherent in Ligand’s business, including, without limitation: Ligand may not receive expected revenue from royalties, Captisol material sales and license fees and milestone revenue; Ligand and its partners may not be able to timely or successfully advance any product(s) in its internal or partnered pipeline; Ligand may not achieve its guidance for 2023; Ligand may not be able to create future revenues and cash flows through its partnerships or otherwise; results of any clinical study may not be timely, favorable or confirmed by later studies; products under development by Ligand or its partners may not receive regulatory approval; the total addressable market for our partners’ products may be smaller than estimated; Ligand faces competition with respect to its technology platforms which may demonstrate greater market acceptance or superiority; Ligand is currently dependent on a single source sole supplier for Captisol and failures by such supplier may result in delays or inability to meet the Captisol demands of its partners; there may not be a market for the product(s) even if successfully developed and approved; Ligand’s partners may not execute on their sales and marketing plans for marketed products for which Ligand has an economic interest; Ligand’s and its partners’ products may not be proved to be safe and efficacious and may not perform as expected and uncertainty regarding the commercial performance of such products; Ligand relies on collaborative partners for milestone payments, royalties, materials revenue, contract payments and other revenue projections; Ligand or its partners may not be able to protect their intellectual property and patents covering certain products and technologies may be challenged or invalidated; Ligand's partners may terminate any of its agreements or development or commercialization of any of its products; 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; 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; unexpected adverse side effects or inadequate therapeutic efficacy of Ligand's or its partners’ product(s) could delay or prevent regulatory approval or commercialization; challenges, costs and charges associated with integrating acquisitions with Ligand’s existing businesses; Ligand may not be able to acquire, stabilize, outlicense or sell Novan's programs or assets; Ligand may not be able to successfully implement its strategic growth plan and continue the development of its proprietary programs; restrictions under Ligand's credit agreement may limit its flexibility in operating its business and a default under the agreement could result in a foreclosure of the collateral securing such obligations; pandemics and other epidemic diseases could adversely impact the business of Ligand and its partners and impair global economic activity; changes in general economic conditions, including as a result of the war between Russia and Ukraine; the spin-off of OmniAb may not achieve the intended strategic, operational and financial benefits; and ongoing or future litigation could expose Ligand to significant liabilities and have a material adverse effect on the company. 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 as well as in Ligand's public periodic filings with the Securities and Exchange Commission available at . Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release, including the possibility of additional license fees and milestone revenues we may receive. 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 Kyprolis, an Amgen product, Rylaze, a Jazz Pharmaceuticals product, Pneumosil, a Serum Institute of India product, Berdazimer gel, a Novan product, FILSPARI, a Travere Therapeutics product, QTORIN, a Palvella Therapeutics product, Veklury, a Gilead Sciences product, and other programs described herein, 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 Pelican Expression TechnologyTM. Solely for convenience, some of the trademarks and copyrights referred to in this press release are listed without the ®, © and ™ 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, except per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Revenues: Royalties $ 20,430 $ 17,820 $ 37,584 $ 31,252 Captisol - Core 5,220 3,325 15,842 9,551 Captisol - COVID — 26,220 — 32,116 Contract revenue 716 2,761 16,919 13,723 Total revenues 26,366 50,126 70,345 86,642 Operating costs and expenses: Cost of Captisol 1,669 12,361 5,386 17,060 Amortization of intangibles 8,539 8,550 17,078 17,130 Research and development 6,854 8,467 13,517 17,646 General and administrative 11,287 12,086 22,142 24,011 Total operating costs and expenses 28,349 41,464 58,123 75,847 Income (loss) from operations (1,983 ) 8,662 12,222 10,795 Gain (loss) from short-term investments 3,991 (1,909 ) 43,524 (14,786 ) Interest income (expense), net 2,036 (140 ) 3,231 (795 ) Other income, net (873 ) 2,048 (270 ) 4,303 Total other income (expense), net 5,154 (1 ) 46,485 (11,278 ) Income (loss) before income taxes 3,171 8,661 58,707 (483 ) Income tax (expense) benefit (881 ) 3,938 (12,803 ) 153 Net income (loss) from continuing operations 2,290 12,599 45,904 (330 ) Net loss from discontinued operations — (13,494 ) (1,665 ) (15,950 ) Net income (loss): $ 2,290 $ (895 ) $ 44,239 $ (16,280 ) Basic net income (loss) from continuing operations per share $ 0.13 $ 0.75 $ 2.67 $ (0.02 ) Basic net loss from discontinued operations per share $ — $ (0.80 ) $ (0.10 ) $ (0.95 ) Basic net income (loss) per share $ 0.13 $ (0.05 ) $ 2.58 $ (0.97 ) Shares used in basic per share calculation 17,276 16,868 17,170 16,846 Diluted net income (loss) from continuing operations per share $ 0.13 $ 0.74 $ 2.57 $ (0.02 ) Diluted net loss from discontinued operations per share $ — $ (0.79 ) $ (0.09 ) $ (0.95 ) Diluted net income (loss) per share $ 0.13 $ (0.05 ) $ 2.48 $ (0.97 ) Shares used in diluted per share calculation 17,730 17,058 17,851 16,846 LIGAND PHARMACEUTICALS INCORPORATED CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in thousands) June 30, 2023 December 31, 2022 Assets Current assets: Cash, cash equivalents and short-term investments $ 219,041 $ 211,870 Accounts receivable, net 27,994 30,424 Inventory 26,906 13,294 Income tax receivable — 4,614 Other current assets 2,770 3,399 Total current assets 276,711 263,601 Deferred income taxes, net 8,530 8,530 Goodwill and other identifiable intangible assets, net 431,050 448,128 Commercial license and other economic rights, net 10,783 10,182 Operating lease right-of-use assets 11,392 10,914 Finance lease 3,762 4,095 Other assets 15,877 17,218 Total assets $ 758,105 $ 762,668 Liabilities and Stockholders' Equity Current liabilities: Accounts payable and accrued liabilities $ 16,873 $ 20,988 Income tax payable 11,387 — Current operating lease liabilities 680 670 2023 convertible senior notes, net — 76,695 Other current liabilities 448 457 Total current liabilities 29,388 98,810 Long-term contingent liabilities 3,505 3,456 Long-term operating lease liabilities 10,991 10,336 Deferred income taxes, net 27,665 30,615 Other long-term liabilities 21,664 21,966 Total liabilities 93,213 165,183 Total stockholders' equity 664,892 597,485 Total liabilities and stockholders' equity $ 758,105 $ 762,668 LIGAND PHARMACEUTICALS INCORPORATED ADJUSTED FINANCIAL MEASURES (Unaudited, in thousands, except per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Net income (loss) from continuing operations $ 2,290 $ 12,599 $ 45,904 $ (330 ) Adjustments: Share-based compensation expense 7,207 7,001 13,138 14,110 Non-cash interest expense (1) 64 175 159 501 Amortization related to acquisitions and intangible assets 8,539 8,550 17,078 17,130 Amortization of commercial license and other economic rights (2) (508 ) (147 ) (1,001 ) (237 ) Change in contingent liabilities (3) 779 (348 ) 108 (939 ) Loss (gain) from short-term investments (3,991 ) 1,909 (43,524 ) 14,786 Realized gain from short-term investments 16,645 (44 ) 37,197 (288 ) Other (4) 94 (1,700 ) 196 (3,366 ) Income tax effect of adjusted reconciling items above (5,655 ) (8,928 ) (3,675 ) (8,669 ) Excess tax benefit from share-based compensation (5) (353 ) 70 (565 ) 87 Adjusted net income from continuing operations $ 25,111 $ 19,137 $ 65,015 $ 32,785 Captisol - COVID gross profit, net of tax (6) — (11,763 ) — (14,384 ) Adjusted net income from continuing operations excluding Captisol - COVID $ 25,111 $ 7,374 $ 65,015 $ 18,401 Diluted per-share amounts attributable to common shareholders: Diluted net income (loss) per share from continuing operations $ 0.13 $ 0.74 $ 2.57 $ (0.02 ) Adjustments: Share-based compensation expense 0.41 0.41 0.75 0.82 Non-cash interest expense (1) — 0.01 0.01 0.03 Amortization related to acquisitions and intangible assets 0.48 0.50 0.97 1.00 Amortization of commercial license and other economic rights (2) (0.03 ) (0.01 ) (0.06 ) (0.01 ) Change in contingent liabilities (3) 0.04 (0.02 ) 0.01 (0.05 ) (Gain)/Loss from short-term investments (0.23 ) 0.11 (2.47 ) 0.86 Realized gain from short-term investments 0.94 — 2.11 (0.02 ) Other (4) 0.01 (0.10 ) 0.01 (0.20 ) Income tax effect of adjusted reconciling items above (0.31 ) (0.52 ) (0.22 ) (0.51 ) Excess tax benefit from share-based compensation (5) (0.02 ) — (0.03 ) 0.01 Adjustment for shares excluded using the if-converted method under ASU 2020-06 (7) — — 0.04 — Adjusted diluted net income per share from continuing operations $ 1.42 $ 1.12 $ 3.69 $ 1.91 Captisol - COVID gross profit, net of tax (6) — (0.69 ) — (0.84 ) Adjusted diluted net income per share from continuing operations excluding Captisol - COVID $ 1.42 $ 0.43 $ 3.69 $ 1.07 GAAP - weighted average number of common shares - diluted 17,730 17,058 17,851 16,846 Shares excluded due to anti-dilutive effect on GAAP net loss — — — 279 Diluted effect of the 2023 Notes (7) — — (240 ) — Adjusted weighted average number of common shares - diluted 17,730 17,058 17,611 17,125 (1) Amounts represent non-cash debt related costs that are calculated in accordance with the authoritative accounting guidance for convertible debt instruments that may be settled in cash. (2) Amounts represent the amortization of commercial license and other economic rights to revenue. (3) Amounts represent changes in fair value of contingent consideration related to CyDex and Metabasis transactions. (4) Amounts primarily relate to gain on debt extinguishment and adjustments associated with our equity investment in Nucorion. (5) Excess tax benefits from share-based compensation are recorded as a discrete item within the provision for income taxes on the consolidated statements of operations as a result of the adoption of an accounting pronouncement (ASU 2016-09) on January 1, 2017. Prior to the adoption, the amount was recognized in additional paid-in capital on the consolidated statement of stockholders' equity. (6) Captisol - COVID gross profit, net of tax, represents gross profit, net of tax, for Captisol supplied for use in formulation with remdesivir, an antiviral treatment for COVID-19. (7) Excluding the impact from the adoption of accounting pronouncement (ASU 2020-06) on January 1, 2022 as the Company intends to settle the principal balance in cash. Under the standard, the Company is required to reflect the dilutive effect of the 2023 Notes by application of the if-converted method, which resulted in an additional 484,463 potentially dilutive shares for the three months ended June 30, 2023, as well as 928,780 and 1,360,030 potentially dilutive shares for the three and six months ended June 30, 2022, respectively. View source version on businesswire.com: Contacts Ligand Pharmaceuticals Incorporated Simon Latimer investors@ligand.com (858) 550-7766 Twitter: @Ligand_LGND LifeSci Advisors Bob Yedid bob@lifesciadvisors.com (516) 428-8577 Source: Ligand Pharmaceuticals Incorporated View this news release online at: