Adapalene/Benzoyl Peroxide/Clindamycin

《中东北非（MENA）地区医药市场进入策略全面剖析》重磅直播课程，火热报名中！2023年10月，FDA批准多款新药，包括新分子实体、新适应症及新制剂等，预计很快就会上市，造福广大患者。以下为上月批准新药的情况汇总，以期为相关药品研发企业提供参考。01Cosentyx生产厂家：诺华申请类型：新适应症图1. Cosentyx作用机制示意图，来源：药渡数据Cosentyx（secukinumab，司库奇尤单抗）是第一个也是唯一一个特异性靶向和阻断白细胞介素-17A（IL-17A）的全人类生物制剂。此前，已批准治疗银屑病关节炎、中度至重度斑块状银屑病、强直性脊柱炎和非影像学中轴型脊柱关节炎。2023年10月6日，FDA批准Cosentyx用于治疗成人中度至重度化脓性汗腺炎（HS），批准的剂量为300mg。此次批准是基于临床三期项目SUNSHINE和SUNRISE的分析，其中每两周或每四周服用Cosentyx 300mg的患者，化脓性汗腺炎临床反应（HisCR50）缓解的比例高于安慰剂。02VELSIPITY生产厂家：Pfizer申请类型：新分子VELSIPITY（etrasimod，伊曲莫德）是一种每日一次的口服鞘氨醇1-磷酸（S1P） 受体调节剂，可选择性地与S1P受体亚型1、4和5结合。图2. VELSIPITY结构式，来源：药渡数据2023年10月12日FDA批准用于治疗成人中度至重度活动性溃疡性结肠炎（UC）。VELSIPITY的批准推荐剂量为2毫克。FDA的批准是基于ELEVATE UC的3期临床的结果，该项目评估了VELSIPITY 2mg每日一次剂量，对既往至少一种常规生物制剂或Janus激酶（JAK）抑制剂治疗失败或不耐受的UC患者临床缓解的安全性和有效性。研究均达到所有主要和关键的次要疗效终点，表明其良好的安全性与有效性。03XPHOZAH生产厂家：ARDELYX INC申请类型：新适应症图3. Xphozah结构式，来源：药渡数据2023年10月17日，美国FDA批准Xphozah（tenapanor）用于降低患有慢性肾脏病（CKD）成人透析患者的血清磷水平，作为对磷酸盐结合剂应答不足或对任何剂量的磷酸盐结合剂治疗不耐受的患者的附加治疗。磷含量高的慢性肾脏病患者传统上使用磷酸盐结合剂进行治疗。这种结合剂可以在消化过程中从食物中吸收磷，使用剂量较大。Xphozah是第一个也是目前唯一一个磷酸盐吸收抑制剂，它是一种单片剂，每天服用两次。Xphozah的批准基于三项3期临床试验，分别为TEN-02-201[NCT02675998]、TEN-02-301[NCT03427125]和TEN-02-202[NCT03824587]。这些试验的重点是评估Xphozah降低透析成人慢性肾脏病患者血清磷的安全性和有效性，所有试验都成功达到了主要和关键的次要终点。此前，tenapanor已于2019年获得FDA批准用于治疗成人便秘型肠易激综合征，商品名为Ibsrela。04COMBOGESIC IV生产厂家：AFT PHARMS LTD申请类型：新组合物2023年10月17日，FDA批准Maxgesic®IV，用于缓解轻度至中度疼痛，并作为成人阿片类止痛药的辅助药物，用于治疗中度至重度疼痛。Maxigestic®IV是1000mg扑热息痛和300mg布洛芬溶液的独特组合，用于术后输液。将以Combogesic®IV的商品名在美国上市。此次批准是基于III期临床阶段项目的积极数据，在该项目中，Maxgesic®IV证明与对乙酰氨基酚IV、布洛芬IV以及安慰剂相比，它具有良好的耐受性，起效更快，疼痛缓解率更高。Maxigestic®IV的卓越镇痛效果，也得到了包括阿片类药物使用率的降低等一系列次要终点的支持。05ZILBRYSQ生产厂家：UCB INC申请类型：新分子图4. zilucoplan知识图谱，来源：药渡数据2023年10月17日， FDA批准zilucoplan（商品名：Zilbrysq）的新药上市申请，用于治疗乙酰胆碱受体（AChR）抗体阳性的全身型重症肌无力（gMG）成年患者。该药是首款获FDA批准用于gMG的补体C5抑制剂，每日自行皮下给药一次。zilucoplan的双重作用机制，可阻止末端补体途径的激活以及膜攻击复合物（MAC）的下游组装和活性，从而阻止其损坏突触后膜，破坏离子通道传导和损害神经肌肉信号传递。此次获批主要基于一项随机双盲、安慰剂对照的多中心III期RAISE研究结果。与安慰剂相比，第12周时zilucoplan组患者重症肌无力-日常生活活动能力量表(MG-ADL)总评分较基线有统计学意义上的改善；zilucoplan组的重症肌无力定量评分(QMG)、重症肌无力复合评分(MGC)和改良的15项重症肌无力生活质量(MG-QoL15r）评分较基线均有显著改善。06QLOSI生产厂家：ORASIS PHARMACEUTICALS, LTD申请类型：新制剂2023年10月17日，美国FDA批准Qlosi（0.4%盐酸毛果芸香碱滴眼液）上市，用于治疗成人老花眼。Qlosi是一种不含防腐剂的低剂量毛果芸香碱和多面载体构成的滴眼液。主要作用机制是收缩瞳孔，从而增强景深，改善近视力和中距视力。Qlosi可每日使用，或根据需要使用，每日最多两次。此次批准是基于III期临床试验NEAR-1和NEAR-2的结果。两项试验均在第8天达到其主要和关键次要终点，显著提高了视力表多读三行的患者比例。接受第一剂治疗后一小时内40%的患者多读三行，这一比例在接受第二剂治疗后达到50%。受试者最早在接受治疗20分钟后，就可获得视力改善，并且疗效可持续长达8个小时。07BIMZELX生产厂家：UCB INC申请类型：新适应症2023年10月17日， FDA批准BIMZELX®(bimekizumab-bkzx)用于治疗中度至重度斑块性银屑病的成人患者。Bimekizumab是首个也是唯一一个被批准用于治疗成人中重度斑块型银屑病的IL-17A和IL-17F抑制剂，作用机制为选择性抑制驱动炎症过程的关键细胞因子——白细胞介素17A (IL-17A)和白细胞介素17F (IL-17F)。Bimekizumab的批准得到了三个III期、多中心、随机、安慰剂和/或活性对照试验的数据支持，这些试验评估了bimekizumab在1480名中度至重度斑块性银屑病成人患者中的疗效和安全性。在第16周，85%-91%接受BIMZELX治疗的患者获得了清晰或几乎清晰的皮肤，59-68%达到了完全清除的目标。08ZITUVIO生产厂家：ZYDUS WORLDWIDE DMCC申请类型：活性成分新盐型2023年10月18日，FDA批准Zituvio（sitagliptin）上市，作为饮食和运动的辅助药物，以改善成人2型糖尿病的血糖控制。Zituvio含有活性成分sitagliptin，一种二肽基肽酶-4（DPP-4）抑制剂。肠促生长素，包括胰高血糖素样肽-1（GLP-1）和葡萄糖依赖性促胰岛素多肽（GIP），全天由肠道释放，并且水平会随着用餐而升高。sitagliptin通过减缓肠促生长素的失活，而在2型糖尿病患者中发挥作用。sitagliptin于2006年首次以Januvia（磷酸西格列汀）的商品名获得批准。Zituvio为含有游离碱形式的sitagliptin。09CABTREO生产厂家：BAUSCH HEALTH US, LLC申请类型：新组合物2023年10月20日，FDA批准Cabtreo（磷酸克林霉素、阿达帕林和过氧化苯甲酰）外用凝胶1.2%/0.15%/3.1%的新药申请，适用于十二岁及以上寻常痤疮患者的局部治疗。该药结合抗生素、类维生素A和抗菌剂三种作用机制，旨在治疗与中度至重度痤疮相关的炎症、细菌和毛囊角化过度。是首个也是当前唯一一个经FDA批准的固定剂量、三联组合的痤疮局部治疗药物。两项多中心、随机、双盲III期临床试验（试验1和试验2，分别为NCT04214639和2NCT04214652）评估表明，在试验1中，接受Cabtreo治疗的患者获得皮肤症状清除或几乎清除的比例(49.6%)，显著高于接受赋形剂凝胶治疗的患者(24.9%)。在试验2中，接受Cabtreo治疗成功的患者(50.5%)相对于赋形剂凝胶组(20.5%)，具有与试验1一致的显著治疗成功率。10ZYMFENTRA生产厂家：CELLTRION申请类型：新制剂图5. Zymfentra作用机制示意图，来源：药渡数据Infliximab是一种抗肿瘤坏死因子α（tumor necrosis factor alpha，TNFα）的单克隆抗体。2023年10月20日，FDA批准Zymfentra（infliximab）用于中重度活动性溃疡性结肠炎（UC）和克罗恩病（CD）成人患者，在接受静脉给予infliximab单抗治疗后的维持治疗。Zymfentra是获FDA批准用以治疗炎症性肠病（IBD）的首个infliximab皮下制剂，可提供血清中稳定升高的infliximab单抗水平。一项随机、安慰剂对照、双盲、III期研究LIBERTY-UC表明第54周时，ZYMFENTRA的临床缓解率 (43.2%) 显著高于安慰剂 (20.8%)。一项随机、安慰剂对照、双盲III期研究LIBERTY-CD表明第54周时，ZYMFENTRA组的临床缓解率高于安慰剂组（分别为62.3%和32.1%，P<0.0001）。与此同时，ZYMFENTRA组在第54周时的内镜缓解率也高于安慰剂组（分别为51.1%和17.9%，P<0.0001）。ZYMFENTRA和安慰剂组在维持阶段的安全性总体上相当。11AGAMREE生产厂家：SANTHERA PHARMA申请类型：新分子图6. 其最新FDA批准状态，来源：药渡数据2023年10月26日，FDA批准Agamree(vamorolone)上市，用于治疗2岁及以上患者的杜氏肌营养不良症(DMD)。Agamree以40mg/mL口服混悬液形式提供，通过糖皮质激素受体发挥抗炎和免疫抑制作用。此次批准基于随机、双盲、安慰剂和活性对照的2b期VISION-DMD研究(NCT03439670)的数据，该研究评估了vamorolone对4岁至7岁DMD患儿的疗效和安全性。服用vamorolone 6mg/kg/天的治疗达到了主要终点，在24周时从基线到站立测试(TTSTAND)速度的变化优于安慰剂。此外，在多个次要终点方面优于安慰剂，包括站立速度、6分钟步行测试及10米跑/走时间。12OMVOH生产厂家：ELI LILLY AND CO申请类型：新适应症2023年10月26日，IL-23p19单抗Mirikizumab（商品名：Omvoh）获得FDA批准，用于治疗成人中至重度溃疡性结肠炎（UC）。该药品为首个获批用于治疗UC的IL-23抗体。Mirikizumab是一种人源化IgG4单克隆抗体，能够特异性地与IL-23的p19亚基结合，从而阻断IL-23介导的炎症反应而不影响IL-12介导的免疫反应。IL-23是一种参与炎症过程的细胞因子，被认为与多种慢性免疫介导的疾病相关。FDA的批准是基于两项随机双盲、安慰剂对照的临床III期试验。一项是为期12周的诱导治疗研究（UC-1），另一项是为期40周的维持治疗研究（UC-2）。试验结果显示，Omvoh治疗12周后，65%的患者获得临床应答，24%的患者获得临床缓解，而安慰剂组的临床应答和临床缓解率分别为43%和15%。在12周达到临床缓解的患者中，66%的患者在连续治疗1年期间维持临床缓解，而安慰剂组则为40%。安全性方面，与安慰剂组（UC-1为7.2%，UC-2为8.3%）相比，使用Omvoh的患者因不良事件停止治疗的可能性较小（UC-1和UC-2分别为1.6%和1.5%）。13CABAZITAXEL生产厂家：SANDOZ申请类型：新制剂2023年10月27日，FDA批准山德斯公司提交卡巴他赛注射液505 (b)(2)申请，此次获批基于FDA对上市药物JEVTANA(卡巴他赛)注射液60mg/1.5mL(NDA#201023;赛诺菲-安万特)的安全性和有效性的调查结果。JEVTANA于2010年6月17日获批，作为一种两瓶制剂，用于治疗激素难治性转移性前列腺癌患者。山德士提交的卡巴他赛注射液的活性成分、给药途径和剂型与JEVTANA相同。山德士制剂的规格为10mg/mL，有4.5mg/4.5mL小瓶和60mg/6ml小瓶两种包装。给药前，用0.9%氯化钠溶液或5%葡萄糖溶液稀释后输注。含有一瓶13%乙醇的稀释剂，给药前需要进行两步稀释，与JEVTANA不同，山德士产品不需要两步稀释。此外，山德士产品的辅料含量不同，乙醇浓度增加到19.8%，并且含有聚乙二醇300 (PEG 300)，而JEVTANA不含PEG。由于该药品依赖于Jevtana的安全性和有效性，因此，没有提交新的临床信息。14LOQTORZI生产厂家：COHERUS BIOSCIENCES INC申请类型：新适应症2023年10月27日，君实生物海外合作方Coherus Biosciences宣布，PD-1单抗特瑞普利单抗LOQTORZI™ (toripalimab-tpzi) 已获FDA批准，联用顺铂/吉西他滨一线治疗晚期复发或转移性鼻咽癌（NPC）；作为单药疗法，用于铂类化疗后进展的不可切除或转移性鼻咽癌（NPC）NPC。这是国产PD-1在美国斩获的首个上市批准，具有里程碑意义。此前，美国地区尚无其他PD-1单抗获批鼻咽癌适应症。此次获批基于JUPITER-02（一项随机、双盲、安慰剂对照、国际多中心III期临床研究）及POLARIS-02（一项多中心、开放标签、II期关键注册临床研究）的研究结果。相较于对照组，特瑞普利单抗+化疗显著延长mPFS 13.2 个月，提升了近3倍，疾病进展或死亡风险降低 48%。3 年OS率较对照组提升了15.3%，死亡风险降低37%，具有显著的统计学差异。封面图来源：123rf恶性肿瘤的细胞免疫治疗现状与iNKT细胞疗法新进展《中东北非（MENA）地区医药市场进入策略全面剖析》重磅直播课程，火热报名中！DRUGTIMES点击在看 共济新药研发浪潮

Revenue of $2.24 billion, up 9% on both a Reported and Organic1 basis Year-over-year revenue growth in all segments on both a Reported and Organic Basis GAAP Net Loss Attributable to Bausch Health Companies Inc. of $378 Million Adjusted EBITDA Attributable to Bausch Health Companies Inc. (non-GAAP)1 of $830 Million, up 8% Provides updated full-year Revenue and Adjusted EBITDA (non-GAAP)1 guidance Received U.S. Food and Drug Administration ("FDA") approval for CABTREOTM (IDP-126), the first and only FDA-approved fixed-dose, triple-combination topical treatment for acne LAVAL, QC / ACCESSWIRE / November 2, 2023 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) ("Bausch Health" or the "Company" or "we" or "our") today announced its third-quarter 2023 financial results and other key updates from the quarter. "We are pleased with our solid third-quarter performance, as each of our business segments posted year-over-year revenue growth on both a reported and organic basis. We remain focused on advancing our R&D pipeline, strengthening our balance sheet and executing on our commercial strategies to drive global growth," said Thomas J. Appio, Chief Executive Officer, Bausch Health. Bausch Health (excl. B+L) R&D Update RED-C: prevention and delay of first episode of hepatic encephalopathy Enrollment of two global Phase 3 trials on track and expected to be completed in Q1 2024 Amiselimod (S1P modulator): treatment of mild to moderate Ulcerative Colitis Phase 2 study completed enrollment in July 2023 and induction portion of the study is expected to be completed in Q4 2023 CABTREOTM: first triple combination product for the treatment of acne vulgaris Received FDA approval on October 20, 2023 Commercial launch expected in Q1 2024 New Drug Submission was submitted to Health Canada on May 30, 2023 Clear + Brilliant® Touch: fractionated laser device for skin rejuvenation Planned regulatory submissions on track for Europe, Canada, and Asia Pacific markets in 2024 Next Generation Fraxel®: fractionated laser device for skin resurfacing FDA submission planned in Q1 2024 and approval is expected 1H 2024 ___________________________________ 1 This is a non-GAAP measure or a non-GAAP ratio. For further information on non-GAAP measures and non-GAAP ratios, please refer to the "Non-GAAP Information" section of this news release. Please also refer to tables at the end of this news release for a reconciliation of this and other non-GAAP measures to the most directly comparable GAAP measure. Third Quarter 2023 Revenue Performance Total reported revenues were $2.24 billion for the third quarter of 2023, compared with $2.05 billion in the third quarter of 2022, an increase of $192 million, or 9%. Excluding the impact of foreign exchange of $6 million and acquisitions, divestitures, and discontinuations of $19 million, revenue increased by 9% organically1 compared with the third quarter of 2022. Reported revenues by segment were as follows: Three Months Ended September 30, Reported Change (in millions) 2023 2022 Amount Pct. Change at Constant Currency1 (Non-GAAP) Change in Organic Revenue1 (Non-GAAP) Total Bausch Health Revenues $ 2,238 $ 2,046 $ 192 9 % 9 % 9 % Bausch Health (excl. B+L) $ 1,231 $ 1,104 $ 127 12 % 10 % 10 % Salix segment $ 614 $ 544 $ 70 13 % 13 % 13 % International segment $ 275 $ 250 $ 25 10 % 3 % 4 % Solta Medical segment $ 83 $ 72 $ 11 15 % 17 % 17 % Diversified segment $ 259 $ 238 $ 21 9 % 9 % 9 % Bausch + Lomb segment $ 1,007 $ 942 $ 65 7 % 8 % 7 % Salix Segment Salix segment reported and organic1 revenues were $614 million for the third quarter of 2023, compared with $544 million for the third quarter of 2022, an increase of $70 million, or 13%. Sales growth was driven by Xifaxan®, Relistor®, and Trulance®. International Segment International segment reported revenues were $275 million for the third quarter of 2023, compared with $250 million for the third quarter of 2022, an increase of $25 million, or 10%. Excluding the impact of foreign exchange of $17 million and divestitures and discontinuations of $1 million, segment revenues increased organically1 by 4% compared with the third quarter of 2022, led by strong performances in Latin America and Poland. Solta Medical Segment Solta Medical segment reported revenues were $83 million for the third quarter of 2023, compared with $72 million in the third quarter of 2022, an increase of $11 million, or 15%, which was driven by growth in the Asia Pacific region. Excluding the impact of foreign exchange of $1 million, segment revenues increased organically1 by 17% compared with the third quarter of 2022. Diversified Segment Diversified segment reported revenues were $259 million for the third quarter of 2023, compared with $238 million for the third quarter of 2022, an increase of $21 million, or 9% on both a reported and organic1 basis, primarily attributable to increases in sales in Generics and Neurology. Bausch + Lomb Segment Bausch + Lomb segment reported revenues were $1,007 million for the third quarter of 2023, compared with $942 million for the third quarter of 2022, an increase of $65 million, or 7%. Excluding the impact of foreign exchange of $10 million, acquisitions of $15 million and divestitures and discontinuations of $3 million, the Bausch + Lomb segment revenue increased organically1 by 7%, compared with the third quarter of 2022, driven by increases across all business units. Consolidated Operating Income Consolidated operating income was $14 million for the third quarter of 2023, compared with operating income of $244 million for the third quarter of 2022, a decrease of $230 million. The change is primarily due to an increase in goodwill impairments, higher selling, general and administrative expenses, and investments in research and development, which were partially offset by higher revenues and associated gross profit, and lower amortization of intangible assets. Net (Loss) Income Attributable to Bausch Health Net loss attributable to Bausch Health for the third quarter of 2023 was $378 million, compared with net income attributable to Bausch Health of $399 million for the third quarter of 2022, a decrease of $777 million, primarily due to the decrease in Operating Income and a gain on extinguishment of debt of $570 million recorded in the third quarter of 2022. Adjusted net income attributable to Bausch Health (non-GAAP)1 for the third quarter of 2023 was $377 million, compared with $277 million for the third quarter of 2022, an increase of $100 million primarily due to higher revenues and gross profit, partially offset by higher selling, general and administrative expenses and investments in research and development. (Loss) Earnings Per Share Attributable to Bausch Health GAAP loss per share attributable to Bausch Health for the third quarter of 2023 was $1.03, compared with earnings per share of $1.10 for the third quarter of 2022. Adjusted EBITDA Attributable to Bausch Health (non-GAAP)1 Adjusted EBITDA attributable to Bausch Health (non-GAAP )1 was $830 million for the third quarter of 2023, as compared to $766 million for the third quarter of 2022, an increase of $64 million. Cash Provided by (Used in) Operating Activities The Company generated $281 million of cash from operating activities in the third quarter of 2023 compared with cash used of $1,263 million in the third quarter of 2022. The increase in cash flow reflects improved operating results as well as the impact in 2022 of a reduction of $1.2 billion from restricted cash in connection with the settlement of legacy U.S. securities litigation. Balance Sheet Highlights as of September 30, 2023: Cash and cash equivalents of $780 million. Bausch Health (excl. B+L) had availability under its 2027 revolving credit facility of $952 million and Bausch + Lomb had availability of approximately $300 million under its revolving credit facility. Bausch Health (excl. B+L) has an accounts receivable credit facility which provides for up to $600 million of availability, $350 million of which was drawn as of September 30, 2023. 2023 Financial Outlook The Company updated its full-year revenue and Adjusted EBITDA (non-GAAP)1 guidance: Previous Guidance (as of Aug. 3, 2023) Current Guidance (as of Nov. 2, 2023) BHC BHC (excl. B+L) B+L BHC BHC (excl. B+L) B+L Revenues (in Billions) $ 8.45 - $8.65 $ 4.50 - $4.65 $ 3.95 - $4.00 $ 8.585 - $8.710 $ 4.550 - $4.625 $ 4.035 - $4.085 Organic1 growth vs. Prior Year 2%-5% 4%-6% Adjusted EBITDA1 (in Billions) $ 3.00 - $3.15 $ 2.30 - $2.40 $ 0.70 - $0.75 $ 3.01 - $3.11 $ 2.30 - $2.35 $ 0.71 - $0.76 Other than with respect to GAAP revenues, the Company only provides guidance on a non-GAAP basis. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA (non-GAAP)1 to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. Because deductions (such as restructuring, gain or loss on extinguishment of debt and litigation and other matters) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amount of these deductions may be material and, therefore, could result in projected GAAP net income (loss) being materially less than projected Adjusted EBITDA (non-GAAP)1. These statements represent forward-looking information and may represent a financial outlook, and actual results may vary. Please see the risks and assumptions referred to in the "Forward-looking Statements" section of this news release. The guidance in this news release is only effective as of the date it is given and will not be updated or affirmed unless and until the Company publicly announces updated or affirmed guidance. Conference Call Details Date: Thursday, November 2, 2023 Time: 8:00 a.m. ET Webcast: A replay of the conference call will be available on the investor relations website. About Bausch Health Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit and connect with us on Twitter and LinkedIn. Forward-looking Statements This news release contains forward-looking information and statements, within the meaning of applicable securities laws (collectively, "forward-looking statements"), including, but not limited to, statements relating to the Company's: future prospects and performance, financial guidance, research and development efforts and anticipated timing or results thereof, proposed plan to separate its eye health business, including the timing thereof, management of its balance sheet, generation of cash, ability to launch and commercialize new products, including the timing of regulatory processes with respect to the Company's product pipeline, ability to enforce and defend its Xifaxan® intellectual property rights, ability to execute its growth strategies generally, and other corporate and strategic transactions. Forward-looking statements may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and positive and negative variations or similar expressions, and phrases or statements that certain actions, events or results may, could, should or will be achieved, received or taken, or will occur or result, and similar such expressions also identify forward-looking information. These forward-looking statements, including the Company's 2023 financial outlook and full-year guidance, are based upon the current expectations and beliefs of management and are provided for the purpose of providing additional information about such expectations and beliefs, and readers are cautioned that these statements may not be appropriate for other purposes. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Company's most recent annual and quarterly reports and detailed from time to time in the Company's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which risks and uncertainties are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties relating to the Company's plan to separate its eye health business from the remainder of Bausch Health. In particular, the Company can offer no assurance that any spinoff transaction will occur at all, or that any spinoff or other separation transaction will occur on the terms and timelines anticipated by the Company. They also include risks and uncertainties related to the uncertainty of commercial success for new and existing products; challenges to patents; challenges to the Company's ability to enforce and defend against challenges to its patents; the impact of patent expirations and the ability of the company to successfully execute strategic plans. They also include risks and uncertainties related to the challenges the Company faces as a result of the closing of the initial public offering of Bausch + Lomb (the "B+L IPO"), including the transitional services being provided by and to Bausch + Lomb, any potential actual or perceived conflict of interest of some of our directors and officers because of their equity ownership in Bausch + Lomb and/or because they also serve as directors or officers of Bausch + Lomb and our ability to timely consolidate the financial results of the Bausch + Lomb business. They also include, but are not limited to, risks and uncertainties caused by or relating to the COVID-19 pandemic, the potential resurgence of the COVID-19 virus and any resulting reinstitution of lockdowns and other restrictions, the evolving reaction of governments, private sector participants and the public to that pandemic, and the potential effects and economic impact of the pandemic and the reaction to it, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a significant adverse impact on the Company. They also include economic factors, such as interest rate, inflation rate and currency exchange rate fluctuations; and competition, including technological advances, new products and patents attained by competitors. Additional information regarding certain of these material factors and assumptions may be found in the Company's filings described above. The Company believes that the material factors and assumptions reflected in these forward-looking statements are reasonable in the circumstances, but readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law. Non-GAAP Information To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP financial measures and non-GAAP ratios to provide supplemental information to readers. Management uses these non-GAAP measures and ratios as key metrics in the evaluation of the Company's performance and the consolidated financial results and, in part, in the determination of cash bonuses for its executive officers. The Company believes these non-GAAP measures and ratios are useful to investors in their assessment of our operating performance and the valuation of the Company. In addition, these non-GAAP measures and ratios address questions the Company routinely receives from analysts and investors, and in order to assure that all investors have access to similar data, the Company has determined that it is appropriate to make this data available to all investors. However, these measures and ratios are not prepared in accordance with GAAP nor do they have any standardized meaning under GAAP. In addition, other companies may use similarly titled non-GAAP financial measures and ratios that are calculated differently from the way we calculate such measures and ratios. Accordingly, our non-GAAP financial measures and ratios may not be comparable to such similarly titled non-GAAP financial measures and ratios used by other companies. We caution investors not to place undue reliance on such non-GAAP measures and ratios, but instead to consider them with the most directly comparable GAAP measures and ratios. Non-GAAP financial measures and ratios have limitations as analytical tools and should not be considered in isolation. They should be considered as a supplement to, not a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. The reconciliations of these historic non-GAAP financial measures and ratios to the most directly comparable financial measures and ratios calculated and presented in accordance with GAAP are shown in the tables below. However, as indicated above, for guidance purposes, the Company does not provide reconciliations of projected Adjusted EBITDA (non-GAAP) to projected GAAP Net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations. Specific Non-GAAP Measures Adjusted EBITDA (non-GAAP) and Adjusted EBITDA attributable to Bausch Health (non-GAAP) Adjusted EBITDA (non-GAAP) is Net income (loss) (its most directly comparable GAAP financial measure) adjusted for interest expense, net, (Benefit from) provision for income taxes, depreciation and amortization and certain other items described below. Adjusted EBITDA attributable to Bausch Health (non-GAAP) is Adjusted EBITDA (non-GAAP) further adjusted to exclude the Adjusted EBITDA attributable to noncontrolling interest (non-GAAP) as defined below. Management believes that Adjusted EBITDA (non-GAAP) and Adjusted EBITDA attributable to Bausch Health (non-GAAP), along with the GAAP measures used by management, most appropriately reflect how the Company measures the business internally and sets operational goals and incentives. In particular, the Company believes that these metrics focus management of the Company's underlying operational results and business performance. As a result, the Company uses these metrics to assess the financial performance of the Company and to forecast future results as part of its guidance. Management believes these metrics are a useful measure to evaluate current performance. These metrics are intended to show our unleveraged, pre-tax operating results and therefore reflects our financial performance based on operational factors. In addition, cash bonuses for the Company's executive officers and other key employees are based, in part, on the achievement of certain Adjusted EBITDA (non-GAAP) targets. Adjusted EBITDA (non-GAAP) is Net income (loss) (its most directly comparable GAAP financial measure) adjusted for interest expense, net, (Benefit from) provision for income taxes, depreciation and amortization and the following items: Asset impairments, including loss on assets held for sale: The Company has excluded the impact of impairments of finite-lived and indefinite-lived intangible assets, as well as impairments of assets held for sale, as such amounts are inconsistent in amount and frequency and are significantly impacted by the timing and/or size of acquisitions and divestitures. The Company believes that the adjustments of these items correlate with the sustainability of the Company's operating performance. Although the Company excludes impairments of intangible assets and assets held for sale from measuring the performance of the Company and the business, the Company believes that it is important for investors to understand that intangible assets contribute to revenue generation. Goodwill impairments: The Company excludes the impact of goodwill impairments. When the Company has made acquisitions where the consideration paid was in excess of the fair value of the net assets acquired, the remaining purchase price is recorded as goodwill. For assets that we developed ourselves, no goodwill is recorded. Goodwill is not amortized but is tested for impairment. The amount of goodwill impairment is measured as the excess of a reporting unit's carrying value over its fair value. Management excludes these charges in measuring the performance of the Company and the business. Restructuring, integration and transformation costs: The Company has incurred restructuring costs as it implemented certain strategies, which involved, among other things, improvements to its infrastructure and operations, internal reorganizations and impacts from the divestiture of assets and businesses. With regard to infrastructure and operational improvements which the Company has taken to improve efficiencies in the businesses and facilities, these tend to be costs intended to right size the business or organization that fluctuate significantly between periods in amount, size and timing, depending on the improvement project, reorganization or transaction. Additionally, with the completion of the B+L IPO, as the Company prepares for post-separation operations, the Company is launching certain transformation initiatives that will result in certain changes to and investment in its organizational structure and operations. These transformation initiatives arise outside of the ordinary course of continuing operations and, as is the case with the Company's restructuring efforts, costs associated with these transformation initiatives are expected to fluctuate between periods in amount, size and timing. These out-of-the-ordinary-course charges include third-party advisory costs, as well as certain severance-related costs (including the severance costs associated with the departure of Bausch + Lomb's former CEO). Investors should understand that the outcome of these transformation initiatives may result in future restructuring actions and certain of these charges could recur. The Company believes that the adjustments of these items provide supplemental information with regard to the sustainability of the Company's operating performance, allow for a comparison of the financial results to historical operations and forward-looking guidance and, as a result, provide useful supplemental information to investors. Acquisition-related costs and adjustments excluding amortization of intangible assets: The Company has excluded the impact of acquisition-related costs and fair value inventory step-up resulting from acquisitions as the amounts and frequency of such costs and adjustments are not consistent and are significantly impacted by the timing and size of its acquisitions. In addition, the company excludes acquisition-related contingent consideration non-cash adjustments due to the inherent uncertainty and volatility associated with such amounts based on changes in assumptions with respect to fair value estimates, and the amount and frequency of such adjustments are not consistent and are significantly impacted by the timing and size of the Company's acquisitions, as well as the nature of the agreed-upon consideration. In addition, the Company excludes the impact of acquisition-related costs and fair value inventory step-up resulting from acquisitions as the amounts and frequency of such costs and adjustments are not consistent and are impacted by the timing and size of its acquisitions. Gain (loss) on extinguishment of debt: The Company has excluded gain (loss) on extinguishment of debt as this represents a gain or loss from refinancing our existing debt and is not a reflection of our operations for the period. Further, the amount and frequency of such amounts are not consistent and are significantly impacted by the timing and size of debt financing transactions and other factors in the debt market out of management's control. Share-based compensation: The Company has excluded costs relating to share-based compensation. The Company believes that the exclusion of share-based compensation expense assists investors in the comparisons of operating results to peer companies. Share-based compensation expense can vary significantly based on the timing, size and nature of awards granted. Separation and IPO costs and separation-related and IPO-related costs: The Company has excluded certain costs incurred in connection with activities regarding: (i) the separation of the eye-health business and the separation of the Solta aesthetic medical device business (which was suspended in 2022) from the remainder of the Company and (ii) the registration of the eye-health business and the suspended registration of the Solta aesthetic medical device businesses as independent publicly traded entities. Separation and IPO costs are incremental costs directly related to effectuating the separation of the eye-health business and the suspended initial public offering ("IPO") of the Solta aesthetic medical device business (the "Solta IPO"), and include, but are not limited to, legal, audit and advisory fees, talent acquisition costs and costs associated with establishing a new board of directors and related board committees. Separation-related and IPO-related costs are incremental costs indirectly related to the separation of the eye-health business and the suspended Solta IPO and include, but are not limited to, IT infrastructure and software licensing costs, rebranding costs and costs associated with facility relocation and/or modification. As these costs arise from events outside of the ordinary course of continuing operations, the Company believes that the adjustments of these items provide supplemental information with regard to the sustainability of the Company's operating performance, allow for a comparison of the financial results to historical operations and forward-looking guidance and, as a result, provide useful supplemental information to investors. Other Non-GAAP adjustments: The Company has excluded certain other amounts, including legal and other professional fees incurred in connection with legal and governmental proceedings, investigations and information requests regarding certain of our legacy distribution, marketing, pricing, disclosure and accounting practices, litigation and other matters, and net (gain) loss on sale of assets or other disposition of assets. Given the unique nature of the matters relating to these costs, the Company believes these items are not normal operating expenses. For example, legal settlements and judgments vary significantly, in their nature, size and frequency, and, due to this volatility, the Company believes the costs associated with legal settlements and judgments are not normal operating expenses. In addition, as opposed to more ordinary course matters, the Company considers that each of the recent proceedings, investigations and information requests, given their nature and frequency, are outside of the ordinary course and relate to unique circumstances. The Company has also excluded IT infrastructure investments that are the result of other, non-comparable events to measure operating performance. These events arise outside of the ordinary course of continuing operations. The Company has also excluded certain other costs, including professional fees associated with contemplated, but not completed, strategic transactions. The Company excluded these costs as the consideration of such matters are outside of the ordinary course of continuing operations and are infrequent in nature. The Company believes that the exclusion of such out-of-the-ordinary-course amounts provides supplemental information to assist in the comparison of the financial results of the Company from period to period and, therefore, provides useful supplemental information to investors. However, investors should understand that many of these costs could recur and that companies in our industry often face litigation. Adjusted EBITDA attributable to Bausch Health (non-GAAP) is Adjusted EBITDA (non-GAAP) further adjusted to exclude the Adjusted EBITDA attributable to noncontrolling interest (non-GAAP). Adjusted EBITDA attributable to noncontrolling interest (non-GAAP) is Net income attributable to noncontrolling interest (its most directly comparable GAAP financial measure) adjusted for the portion of the adjustments described above attributable to noncontrolling interest. Adjusted Net Income (non-GAAP) and Adjusted Net Income attributable to Bausch Health Adjusted net income (non-GAAP) is Net income (its most directly comparable GAAP financial measure), adjusted for asset impairments, including loss on assets held for sale, goodwill impairments, restructuring, integration and transformation costs, acquisition-related costs and adjustments excluding amortization of intangible assets, gain (loss) on extinguishment of debt, share-based compensation, separation and IPO costs and separation-related and IPO-related costs and other non-GAAP adjustments as these adjustments are described above, and amortization of intangible assets and acquisition-related costs and adjustments excluding amortization of intangible assets, as described below: Amortization of intangible assets: The Company has excluded the impact of amortization of intangible assets, as such amounts are inconsistent in amount and frequency and are significantly impacted by the timing and/or size of acquisitions. The Company believes that the adjustments of these items correlate with the sustainability of the Company's operating performance. Although the Company excludes the amortization of intangible assets from its non-GAAP expenses, the Company believes that it is important for investors to understand that such intangible assets contribute to revenue generation. Amortization of intangible assets that relate to past acquisitions will recur in future periods until such intangible assets have been fully amortized. Any future acquisitions may result in the amortization of additional intangible assets. Acquisition-related costs and adjustments excluding amortization of intangible assets: In addition to the acquisition-related costs and adjustments as described above, the company has excluded the expense directly attributable to one-time commitment and structuring fees related to a bridge loan facility put in place prior to the acquisition of XIIDRA and certain other ophthalmology assets. The company excluded these costs as they are outside of the ordinary course of continuing operations and are infrequent in nature. The company believes that the exclusion of such out-of-the-ordinary-course amounts provides supplemental information to assist in the comparison of the financial results of the company from period to period and, therefore, provides useful supplemental information to investors. Adjusted net income attributable to Bausch Health (non-GAAP) is Adjusted net income (non-GAAP) further adjusted to exclude the Adjusted net income attributable to noncontrolling interest (non-GAAP). Adjusted net income attributable to noncontrolling interest (non-GAAP) is Net income attributable to noncontrolling interest (its most directly comparable GAAP financial measure) adjusted for the portion of the adjustments described above attributable to noncontrolling interest. Historically, management has used Adjusted net income (loss) (non-GAAP) for strategic decision making, forecasting future results and evaluating current performance. This non-GAAP measure excludes the impact of certain items (as described above) that may obscure trends in the Company's underlying performance. By disclosing this non-GAAP measure, it is management's intention to provide investors with a meaningful, supplemental comparison of the Company's operating results and trends for the periods presented. Management believes that this measure is also useful to investors as such measure allows investors to evaluate the Company's performance using the same tools that management uses to evaluate past performance and prospects for future performance. Accordingly, the Company believes that Adjusted net income (non-GAAP) is useful to investors in their assessment of the Company's operating performance. It is also noted that, in recent periods, our GAAP Net income (loss) was significantly lower than our Adjusted net income (non-GAAP). Commencing in 2017, management of the Company identified and began using certain new primary financial performance measures to assess the Company's financial performance. In addition, subsequent to the B+L IPO, the Company began presenting Adjusted net income (non-GAAP) attributable to Bausch Health Companies Inc. as it may be useful to investors in their assessment of the Company and its performance. Organic Revenue (non-GAAP) and Change in Organic Revenue (non-GAAP) Organic revenue (non-GAAP) and Change in organic revenue (non-GAAP), are defined as GAAP Revenue and change in GAAP Revenue (the most directly comparable GAAP financial measures), adjusted for changes in foreign currency exchange rates (if applicable) and excluding the impact of recent acquisitions, divestitures and discontinuations, as defined below. Organic revenue (non-GAAP) is impacted by changes in product volumes and price. The price component is made up of two key drivers: (i) changes in product gross selling price and (ii) changes in sales deductions. The Company uses organic revenue (non-GAAP) and change in organic revenue (non-GAAP) to assess performance of its reportable segments, and the Company in total. The Company believes that providing these non-GAAP measures is useful to investors as they provide a supplemental period-to-period comparison. The adjustments to GAAP Revenue to determine Organic Revenue (non-GAAP) and Changes in Organic Revenue (non-GAAP) are as follows: Foreign currency exchange rates: Although changes in foreign currency exchange rates are part of our business, they are not within management's control. Changes in foreign currency exchange rates, however, can mask positive or negative trends in the business. The impact of changes in foreign currency exchange rates is determined as the difference in the current period reported revenues at their current period currency exchange rates and the current period reported revenues revalued using the monthly average currency exchange rates during the comparable prior period. Acquisitions, divestitures and discontinuations: In order to present period-over-period organic revenue (non-GAAP) growth/change on a comparable basis, revenues associated with acquisitions, divestitures and discontinuations are adjusted to include only revenues from those businesses and assets owned during both periods. Accordingly, organic revenue and change in organic revenue exclude from the current period, revenues attributable to each acquisition for twelve months subsequent to the day of acquisition, as there are no revenues from those businesses and assets included in the comparable prior period. Organic revenue and change in organic revenue exclude from the prior period, all revenues attributable to each divestiture and discontinuance during the twelve months prior to the day of divestiture or discontinuance, as there are no revenues from those businesses and assets included in the comparable current period. Constant Currency Changes in the relative values of non-U.S. currencies to the U.S. dollar may affect the Company's financial results and financial position. To assist investors in evaluating the Company's performance, we have adjusted for the effects of changes in foreign currencies. The impact of changes in foreign currency exchange rates is determined by comparing the current period reported revenues at their current period currency exchange rates and the current period reported revenues revalued using the monthly average currency exchange rates during the comparable prior period. Please also see the reconciliation tables below for further information as to how these non-GAAP measures and ratios are calculated for the periods presented. FINANCIAL TABLES FOLLOW Bausch Health Companies Inc. Table 1 Condensed Consolidated Statements of Operations For the Three and Nine Months Ended September 30, 2023 and 2022 (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2023 2022 2023 2022 Revenues Product sales $ 2,213 $ 2,022 $ 6,281 $ 5,857 Other revenues 25 24 68 74 2,238 2,046 6,349 5,931 Expenses Cost of goods sold (excluding amortization and impairments of intangible assets) 612 573 1,824 1,677 Cost of other revenues 11 11 30 35 Selling, general and administrative 715 661 2,151 1,959 Research and development 153 133 452 387 Amortization of intangible assets 253 290 795 902 Goodwill impairments 402 119 402 202 Asset impairments 4 1 54 15 Restructuring, integration, separation and IPO costs 14 10 40 58 Other expense, net 60 4 - 6 2,224 1,802 5,748 5,241 Operating income 14 244 601 690 Interest income 6 3 19 8 Interest expense (339) (385) (965) (1,157) Gain on extinguishment of debt - 570 - 683 Foreign exchange and other (7) 7 (38) 4 (Loss) income before income taxes (326) 439 (383) 228 Provision for income taxes (56) (36) (181) (30) Net (loss) income (382) 403 (564) 198 Net loss (income) attributable to noncontrolling interest 4 (4) 11 (13) Net (loss) income attributable to Bausch Health Companies Inc. $ (378) $ 399 $ (553 $ 185 Bausch Health Companies Inc. Table 2 Reconciliation of GAAP Net (Loss) income to Adjusted Net Income (non-GAAP) For the Three and Nine Months Ended September 30, 2023 and 2022 (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2023 2022 2023 2022 Net (loss) income $ (382) $ 403 $ (564) $ 198 Non-GAAP adjustments:(a) Amortization of intangible assets 253 290 795 902 Goodwill impairments 402 119 402 202 Asset impairments 4 1 54 15 Restructuring, integration and transformation costs 31 13 85 38 Acquisition-related costs and adjustments (excluding amortization of intangible assets) 60 4 77 2 Gain on extinguishment of debt - (570) - (683) IT infrastructure investment 8 2 22 10 Separation costs, separation-related costs, IPO costs and IPO-related costs 6 27 20 114 Legal and other professional fees 4 4 17 27 Gain on sale of assets, net (5) - (4) (3) Litigation and other matters, net of insurance recoveries 24 - (55) 7 Other 2 - 9 8 Tax effect of non-GAAP adjustments (17) (2) 36 (69) Total non-GAAP adjustments 772 (112) 1,458 570 Adjusted net income (non-GAAP) 390 291 894 768 Adjusted net income attributable to noncontrolling interest (non-GAAP) (13) (14) (26) (27) Adjusted net income attributable to Bausch Health Companies Inc. (non-GAAP) $ 377 $ 277 $ 868 $ 741 (a) The components of and further details respecting each of these non-GAAP adjustments and the financial statement line item to which each component relates can be found on Table 2a. Bausch Health Companies Inc. Table 2a Reconciliation of GAAP to Non-GAAP Financial Information For the Three and Nine Months Ended September 30, 2023 and 2022 (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2023 2022 2023 2022 Cost of goods sold reconciliation: GAAP Cost of goods sold (excluding of amortization and impairments of intangible assets) $ 612 $ 573 $ 1,824 $ 1,677 Fair value inventory step-up resulting from acquisitions(a) (2) - (2) - Adjusted cost of goods sold (excluding of amortization and impairments of intangible assets) (non-GAAP) $ 610 $ 573 $ 1,822 $ 1,677 Selling, general and administrative reconciliation: GAAP Selling, general and administrative $ 715 $ 661 $ 2,151 $ 1,959 IT infrastructure investment(b) (8) (2) (22) (10) Legal and other professional fees(c) (4) (4) (17) (27) Separation-related and IPO-related costs(d) (3) (20) (16) (84) Transformation costs(e) (19) (10) (48) (10) Adjusted selling, general and administrative (non-GAAP) $ 681 $ 625 $ 2,048 $ 1,828 Research and development reconciliation: GAAP Research and development $ 153 $ 133 $ 452 $ 387 Separation-related costs(d) (1) - (1) - Adjusted research and development (non-GAAP) $ 152 $ 133 $ 451 $ 387 Amortization of intangible assets reconciliation: GAAP Amortization of intangible assets $ 253 $ 290 $ 795 $ 902 Amortization of intangible assets(f) (253) (290) $ (795) (902) Adjusted amortization of intangible assets (non-GAAP) $ - $ - $ - $ - Goodwill impairments reconciliation: GAAP Goodwill impairments $ 402 $ 119 $ 402 $ 202 Goodwill impairments(g) (402) (119) (402) (202) Adjusted goodwill impairments (non-GAAP) $ - $ - $ - $ - Asset impairments: GAAP Asset impairments $ 4 $ 1 $ 54 $ 15 Asset impairments(h) (4) (1) (54) (15) Adjusted asset impairments (non-GAAP) $ - $ - $ - $ - Restructuring, integration, separation and IPO costs reconciliation: GAAP Restructuring, integration, separation and IPO costs $ 14 $ 10 $ 40 $ 58 Restructuring and integration costs(e) (12) (3) (37) (28) Separation and IPO costs(d) (2) (7) (3) (30) Adjusted restructuring, integration, separation and IPO costs (non-GAAP) $ - $ - $ - $ - Bausch Health Companies Inc. Table 2a (continued) Reconciliation of GAAP to Non-GAAP Financial Information For the Three and Nine Months Ended September 30, 2023 and 2022 (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2023 2022 2023 2022 Other expense, net reconciliation: GAAP Other expense, net $ 60 $ 4 $ - $ 6 Litigation and other matters, net of insurance recoveries(i) (24) - 55 (7) Acquisition-related contingent consideration(j) (26) (4) (40) (2) Gain on sale of assets, net(k) 5 - 4 3 Acquisition-related costs(l) (15) - (18) - Other(m) (1) - (1) - Adjusted other expense, net (non-GAAP) $ (1) $ - $ - $ - Gain on extinguishment of debt reconciliation: GAAP Gain on extinguishment of debt $ - $ 570 $ - $ 683 Gain on extinguishment of debt(n) - (570) - (683) Adjusted gain on extinguishment of debt (non-GAAP) $ - $ - $ - $ - Interest expense reconciliation: GAAP Interest expense $ (339) $ (385) $ (965) $ (1,157) Acquisition-related financing costs(o) (16) - (16) - Adjusted Interest expense (non-GAAP) $ (355) $ (385) $ (981) $ (1,157) Foreign exchange and other reconciliation: GAAP Foreign exchange and other $ (7) $ 7 $ (38) $ 4 Other(p) (2) - (9) (8) Adjusted foreign exchange and other (non-GAAP) $ (9) $ 7 $ (47) $ (4) Provision for income taxes reconciliation: GAAP Provision for income taxes $ (56) $ (36) $ (181) $ (30) Tax effect of non-GAAP adjustments(q) (17) (2) 36 (69) Adjusted provision for income taxes (non-GAAP) $ (73) $ (38) $ (145) $ (99) Net income attributable to noncontrolling interest reconciliation: GAAP Net loss (income) attributable to noncontrolling interest $ 4 $ (4) $ 11 $ (13) Noncontrolling interest portion of amortization of intangible assets(r) (5) (7) (17) (11) Noncontrolling interest portion of all other adjustments(s) (12) (3) (20) (3) Adjusted net income attributable to noncontrolling interest (non-GAAP) $ (13) $ (14) $ (26) $ (27) (a) Represents the sole component of the non-GAAP adjustment of "Cost of goods sold" (see Table 2). (b) Represents the sole component of the non-GAAP adjustment of "IT infrastructure investment" (see Table 2). (c) Represents the sole component of the non-GAAP adjustment of "Legal and other professional fees" (see Table 2). (d) Represents the two components of the non-GAAP adjustment of "Separation and IPO costs and separation-related and IPO-related costs" (see Table 2). (e) Represents the two components of the non-GAAP adjustment of "Restructuring, integration and transformation costs" (see table 2). (f) Represents the sole component of the non-GAAP adjustment of "Amortization of intangible assets" (see Table 2). (g) Represents the sole component of the non-GAAP adjustment of "Goodwill impairments" (see Table 2). (h) Represents the sole component of the non-GAAP adjustment of "Asset impairments" (see Table 2). (i) Represents the sole component of the non-GAAP adjustment of "Litigation and other matters, net of insurance recoveries" (see Table 2). (j) Represents the sole component of the non-GAAP adjustment of "Acquisition-related costs and adjustments (excluding amortization of intangible assets)" (see Table 2). (k) Represents the sole component of the non-GAAP adjustment of "(Gain) loss on sale of assets, net" (see Table 2). (l) Represents the sole component of the non-GAAP adjustment of "Acquisition-related costs" (see Table 2). (m) Represents the sole component of the non-GAAP adjustment of "Other" (see Table 2). (n) Represents the sole component of the non-GAAP adjustment of "Gain on extinguishment of debt" (see Table 2). (o) Represents the sole component of the non-GAAP adjustment of "Interest expense" (see Table 2). (p) Represents the sole component of the non-GAAP adjustment of "Other" (see Table 2). (q) Represents the sole component of the non-GAAP adjustment of "Tax effect of non-GAAP adjustments" (see Table 2). (r) Represents the portion of the non-GAAP adjustments above attributable to noncontrolling interest (see Table 2). (s) Represents the portion of the non-GAAP adjustments above attributable to all other adjustments (see Table 2). Bausch Health Companies Inc. Table 2b Reconciliation of GAAP Net (Loss) income to Adjusted EBITDA (non-GAAP) For the Three and Nine Months Ended September 30, 2023 and 2022 (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2023 2022 2023 2022 Net (loss) income $ (382) $ 403 $ (564) $ 198 Interest expense, net 333 382 946 1,149 Provision for income taxes 56 36 181 30 Depreciation and amortization 301 335 935 1,034 EBITDA 308 1,156 1,498 2,411 Adjustments: Goodwill impairments 402 119 402 202 Asset impairments 4 1 54 15 Restructuring, integration and transformation costs 31 13 85 38 Acquisition-related costs and adjustments (excluding amortization of intangible assets) 45 4 62 2 Gain on extinguishment of debt - (570) - (683) Share-based compensation 29 33 103 91 Separation costs, separation-related costs, IPO costs and IPO-related costs 6 27 20 114 Other adjustments: Litigation and other matters, net of insurance recoveries 24 - (55) 7 IT infrastructure investment 8 2 22 10 Legal and other professional fees(a) 4 4 17 27 Gain on sale of assets, net (5) - (4) (3) Other 2 - 9 8 Adjusted EBITDA (non-GAAP) 858 789 2,213 2,239 Adjusted EBITDA attributable to noncontrolling interest (non-GAAP)(b) (28) (23) (68) (40) Adjusted EBITDA attributable to Bausch Health Companies Inc. (non-GAAP) $ 830 $ 766 $ 2,145 $ 2,199 (a) Legal and other professional fees incurred during the three and nine months ended September 30, 2023 and 2022 in connection with recent legal and governmental proceedings, investigations and information requests related to, among other matters, our distribution, marketing, pricing, disclosure and accounting practices. (b) Adjusted EBITDA attributable to noncontrolling interest (non-GAAP) is Net (income) loss attributable to noncontrolling interest adjusted for the noncontrolling interest portion of the adjustments above as follows: Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2023 2022 2023 2022 Net loss (income) attributable to noncontrolling interest $ 4 $ (4) $ 11 $ (13) Noncontrolling interest portion of adjustments for: Interest expense, net (9) (4) (21) (6) Depreciation and amortization (9) (11) (29) (17) All other adjustments (14) (4) (29) (4) Adjusted EBITDA attributable to noncontrolling interest (non-GAAP) $ (28) $ (23) $ (68) $ (40) Bausch Health Companies Inc. Organic Growth (non-GAAP) - by Segment For the Three Months Ended September 30, 2023 and 2022 (unaudited) Table 3a Calculation of Organic Revenue for the Three Months Ended September 30, 2023 September 30, 2022 Change in GAAP Revenues Change in Organic Revenue Revenue as Reported Changes in Exchange Rates(a) Acquisitions Organic Revenue (Non-GAAP)(b) Revenue as Reported Divestitures and Discontinuations Organic Revenue (Non-GAAP)(b) Amount Pct. Amount Pct. (in millions) Bausch Health (excl. B+L) Salix $ 614 $ - $ - $ 614 $ 544 $ - $ 544 $ 70 13 % $ 70 13 % International 275 (17 ) - $ 258 250 (1 ) 249 25 10 % 9 4 % Solta Medical 83 1 - $ 84 72 - 72 11 15 % 12 17 % Diversified Neuro 136 - - 136 126 - 126 10 8 % 10 8 % Dermatology 61 - - 61 61 - 61 - - % - - % Generics 38 - - 38 26 - 26 12 46 12 46 % Dentistry 24 - - 24 25 - 25 (1 ) (4 )% (1 ) (4 )% Total Diversified 259 - - 259 238 - 238 21 9 % 21 9 % Bausch Health (excl. B+L) revenues 1,231 (16 ) - $ 1,215 1,104 (1 ) 1,103 127 12 % 112 10 % Bausch + Lomb Vision Care 648 13 (12 ) 649 597 (2 ) 595 51 9 % 54 9 % Surgical 185 (3 ) (3 ) 179 172 (1 ) 171 13 8 % 8 5 % Pharmaceuticals 174 - - 174 173 - 173 1 1 % 1 1 % Total Bausch + Lomb revenues 1,007 10 (15 ) $ 1,002 942 (3 ) 939 65 7 % 63 7 % Total Bausch Health Companies Inc. revenues $ 2,238 $ (6 ) $ (15 ) $ 2,217 $ 2,046 $ (4 ) $ 2,042 $ 192 9 % $ 175 9 % (a) The impact for changes in foreign currency exchange rates is determined as the difference in the current period reported revenues at their current period currency exchange rates and the current period reported revenues revalued using the monthly average currency exchange rates during the comparable prior period. (b) To supplement the financial measures prepared in accordance with GAAP, the Company uses certain non-GAAP financial measures. For additional information about the Company's use of such non-GAAP financial measures, refer to the body of the news release to which these tables are attached. Organic revenue (non-GAAP) for the three months ended September 30, 2023 is calculated as revenue as reported adjusted for the impact for changes in exchange rates (previously defined in this news release) and acquisitions. Organic revenue (non-GAAP) for the three months ended September 30, 2022 is calculated as revenue as reported less revenues attributable to divestitures and discontinuances during the twelve months prior to the day of divestiture or discontinuance, as there are no revenues from those businesses and assets included in the comparable current period. Bausch Health Companies Inc. Organic Growth (non-GAAP) - by Segment For the Nine Months Ended September 30, 2023 and 2022 (unaudited) Table 3b Calculation of Organic Revenue for the Nine Months Ended September 30, 2023 September 30, 2022 Change in GAAP Revenues Change in Organic Revenue Revenue as Reported Changes in Exchange Rates(a) Acquisitions Organic Revenue (Non-GAAP)(b) Revenue as Reported Divestitures and Discontinuations Organic Revenue (Non-GAAP)(b) Amount Pct. Amount Pct. (in millions) Bausch Health (excl. B+L) Salix $ 1,667 $ - $ - $ 1,667 $ 1,509 $ - $ 1,509 $ 158 10 % $ 158 10 % International 781 (15 ) - 766 727 (8 ) 719 54 7 % 47 7 % Solta Medical 244 7 - 251 201 - 201 43 21 % 50 25 % Diversified Neuro 353 - - 353 375 - 375 (22 ) (6 )% (22 ) (6 )% Dermatology 165 - - 165 178 - 178 (13 ) (7 )% (13 ) (7 )% Generics 92 - - 92 96 - 96 (4 ) (4 )% (4 ) (4 )% Dentistry 74 - - 74 73 - 73 1 1 % 1 1 % Total Diversified 684 - - 684 722 - 722 (38 ) (5 )% (38 ) (5 )% Bausch Health (excl. B+L) revenues 3,376 (8 ) - 3,368 3,159 (8 ) 3,151 217 7 % 217 7 % Bausch + Lomb Vision Care 1,881 48 (12 ) 1,917 1,745 (2 ) 1,743 136 8 % 174 10 % Surgical 563 4 (7 ) 560 530 (5 ) 525 33 6 % 35 7 % Pharmaceuticals 529 7 - 536 497 - 497 32 6 % 39 8 % Total Bausch + Lomb revenues 2,973 59 (19 ) 3,013 2,772 (7 ) 2,765 201 7 % 248 9 % Total Bausch Health Companies Inc. revenues $ 6,349 $ 51 $ (19 ) $ 6,381 $ 5,931 $ (15 ) $ 5,916 $ 418 7 % $ 465 8 % (a) The impact for changes in foreign currency exchange rates is determined as the difference in the current period reported revenues at their current period currency exchange rates and the current period reported revenues revalued using the monthly average currency exchange rates during the comparable prior period. (b) To supplement the financial measures prepared in accordance with GAAP, the Company uses certain non-GAAP financial measures. For additional information about the Company's use of such non-GAAP financial measures, refer to the body of the news release to which these tables are attached. Organic revenue (non-GAAP) for the nine months ended September 30, 2023 is calculated as revenue as reported adjusted for the impact for changes in exchange rates (previously defined in this news release) and acquisitions. Organic revenue (non-GAAP) for the nine months ended September 30, 2022 is calculated as revenue as reported less revenues attributable to divestitures and discontinuances during the twelve months prior to the day of divestiture or discontinuance, as there are no revenues from those businesses and assets included in the comparable current period. Bausch Health Companies Inc. Table 4 Other Financial Information (unaudited) (in millions) September 30, 2023 December 31, 2022 Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents $ 760 $ 564 Restricted cash 20 27 Cash, cash equivalents and restricted cash $ 780 $ 591 Debt Obligations Senior Secured Credit Facilities: Revolving Credit Facilities $ 175 $ 470 AR Credit Facility 350 - Term Loan Facilities 5,312 4,925 Senior Secured Notes 9,305 7,905 Senior Unsecured Notes 5,798 5,798 Other 12 12 Total long-term debt and other, net of premiums, discounts and issuance costs 20,952 19,110 Plus: Unamortized premiums, discounts and issuance costs 1,478 1,656 Total long-term debt and other $ 22,430 $ 20,766 Maturities of Debt Obligations (at principal amount) Remainder of 2023 $ 39 $ 150 2024 155 150 2025 2,794 2,789 2026 896 891 2027 6,648 6,938 2028 7,218 4,990 2029 - 2032 3,202 3,202 Total debt obligations $ 20,952 $ 19,110 Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Cash provided by (used in) operating activities $ 281 $ (1,263) $ 642 $ (1,203) Investor Contacts: Media Contact: Lisa Wilson Kevin Wiggins ir@bauschhealth.com corporate.communications@bauschhealth.com (877) 281-6642 (toll free) (908) 541-3785 SOURCE: Bausch Health Companies Inc. 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