Lisdexamfetamine Dimesylate

Achieves Third Quarter Net Sales of $505.5 Million, Reflecting 1.7% Year-Over-Year Growth Reaffirms Full Year Net Sales Guidance and Raises Full Year Adjusted EBITDA Guidance After Adjusting Both Metrics for the Therakos Transaction Delivers Third Consecutive Quarter of Acthar® Gel Growth, Underscoring Increase in Patient and Prescriber Demand; Expects Brand to Grow Approximately 10% in Full Year 2024 Successfully Launched Acthar Gel SelfJect™ Device and Expanded the Rollout of INOmax ® EVOLVE™ DS Delivery System to U.S. Hospitals Nationwide Specialty Generics Segment Maintains Momentum with Seventh Consecutive Quarter of Year-Over-Year Growth Net Proceeds from Sale of Therakos ® Business Expected to Reduce Net Debt by More Than 60% in the Fourth Quarter DUBLIN, Nov. 5, 2024 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today reported its financial results for the third quarter ended September 27, 2024.1 "Our third quarter results demonstrate the successful execution of our strategy to stabilize the base business and position Mallinckrodt for long-term growth. We are pleased to reaffirm our full year net sales guidance and again raise our Adjusted EBITDA guidance, even after adjusting for the Therakos transaction," said Siggi Olafsson, President and Chief Executive Officer. "In Specialty Brands, Acthar Gel achieved its third consecutive quarter of growth from rising prescriber referrals and patient demand. We also made important progress on our recent launches, with positive momentum in our Acthar Gel SelfJect device and an expanded rollout of our INOmax EVOLVE DS delivery system to U.S. hospitals nationwide. In Specialty Generics, we delivered our seventh consecutive quarter of solid growth due to our ability to consistently and reliably deliver high-quality products, and we remain on track for another year of double-digit net sales growth in 2024." Mr. Olafsson added, "I am grateful to our teams for their continued commitment to Mallinckrodt, bringing our strategy to life and serving our patients. It is because of their efforts that we are positioned to finish 2024 on a strong note as we continue building on our momentum and advancing our strategic priorities." Third Quarter 2024 Financial Results1 Mallinckrodt's net sales in the third quarter of 2024 were $505.5 million, as compared to $497.0 million in the third quarter of 2023. This reflects an increase of 1.7% on a reported and constant currency basis. The Company's Specialty Brands segment reported net sales of $286.0 million, as compared to $286.2 million in the third quarter of 2023. This stability reflects growth in Acthar Gel, uptake in Acthar SelfJect and Terlivaz® and the continued growth of Therakos, slightly offset by continued competition in the U.S. for INOmax from alternative nitric oxide products. Mallinckrodt's Specialty Generics segment reported net sales of $219.5 million, as compared to $210.8 million in the third quarter of 2023. This 4.1% growth was driven by the Company's established track record as a reliable and consistent producer of high-quality products amidst ongoing market shortages due to quality and other disruptions, in both the finished-dosage products and Controlled Substance active pharmaceutical ingredient (API) businesses, partially offset by a decline in the Acetaminophen (APAP) business as a result of the overall softening of the market. The Company's net loss for the third quarter was $26.2 million, a 98.5% improvement as compared to a net loss of $1.7 billion in the third quarter of 2023. Mallinckrodt's Adjusted EBITDA in the third quarter was $160.6 million, as compared to $180.6 million in the third quarter of 2023, a decrease of 11.1%. This decrease was primarily driven by approximately $7.3 million of transaction-related compensation expenses for the sale of Therakos, as well as incremental commercial investments for Acthar Gel and Terlivaz and the impact of nitric oxide competition in the U.S., partially offset by continued strength in the Specialty Generics segment, and growth in the Specialty Brands segment. Gross profit as a percentage of net sales was 43.7% for the third quarter, as compared to 30.3% for the third quarter of 2023. Adjusted gross profit as a percentage of net sales was 65.4% for the third quarter, as compared to 66.3% for the third quarter of 2023. Mallinckrodt's cash balance at the end of the third quarter of 2024 was $410.5 million. Total outstanding principal debt was $1.64 billion, and outstanding net debt was $1.23 billion. Nine Month 2024 Results1 Mallinckrodt's net sales were $1.5 billion for the nine months ended September 27, 2024, as compared to $1.4 billion for the nine months ended September 29, 2023. This reflects an increase of 6.5%. The Company recorded a net loss of $134.9 million for the nine months ended September 27, 2024, as compared to $2.7 billion for the nine months ended September 29, 2023. Mallinckrodt's Adjusted EBITDA was $479.5 million for the nine months ended September 27, 2024, as compared to $448.1 million for the nine months ended September 29, 2023, an increase of 7.0%. Third Quarter 2024 Business Segment Update Specialty Brands Acthar Gel net sales were $126.4 million in the third quarter, an increase of 3.5% versus the prior year quarter and the third consecutive quarter of year-over-year growth for the brand, reflecting increasing prescriber referrals and patient demand. Additionally, the Company successfully launched SelfJect mid-quarter and has received enthusiastic physician and patient feedback. Given the brand's return to growth and positive momentum, the Company now expects full year 2024 Acthar Gel net sales to grow approximately 10%. Terlivaz net sales were $7.3 million, reflecting 65.9% year-over-year growth and 37.7% sequential growth in net sales. The Company continued to expand adoption in the third quarter through outreach to healthcare providers emphasizing the importance of early patient identification and treatment initiation. Mallinckrodt remains focused on establishing Terlivaz as the preferred first-line treatment for HRS patients with rapid reduction of kidney function. INOmax (nitric oxide) gas net sales in the third quarter were $64.0 million, down 12.2% compared to the prior year period, as it continued to be impacted by competitive pressures in the U.S. Following the successful introduction of the INOmax EVOLVE DS device pilot program earlier this year, the Company expanded the commercial rollout of EVOLVE to U.S. hospitals nationwide late in the third quarter. At quarter end, there were 100 devices in nearly a dozen hospitals across the U.S. The Company is focused on further expanding the rollout of EVOLVE to help meet the needs of neonatal intensive care patients and healthcare professionals by offering improved automation, which enhances safety features, and a streamlined design that elevates the user experience. Therakos net sales were $67.6 million in the third quarter, an increase of 2.4% on a reported basis and 2.2% on a constant currency basis. As previously announced, the Company entered into a definitive agreement to sell the Therakos business to CVC Capital Partners for $925 million, subject to customary adjustments. Mallinckrodt will use net proceeds from the transaction to pay down debt and expects this to reduce the Company's net debt by more than 60% following transaction close. Closing remains on track to occur in the coming weeks, subject to customary closing conditions. Specialty Generics The Specialty Generics segment reported year-over-year net sales growth of 4.1% in the third quarter of 2024. These results were driven by strong performance in finished-dosage products and increased demand for Controlled Substance APIs, slightly offset by softness in the APAP business stemming from excess supply in the broader market. Net sales in the Specialty Generics segment have grown for the past seven quarters, and its third quarter performance is particularly notable given the strong comparable quarter in 2023, which was driven by the launch of lisdexamfetamine dimesylate capsules (generic form of Vyvanse®). Please see "Non-GAAP Financial Measures" included in this release for a discussion of non-GAAP measures and reconciliation of GAAP and non-GAAP financial measures for the third quarter. Please see the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Quarterly Report on Form 10-Q for the quarter ended September 27, 2024 to be filed with the U.S. Securities and Exchange Commission ("SEC") for additional information. 2024 Financial Guidance Update Mallinckrodt today reaffirmed its net sales guidance and raised its Adjusted EBITDA guidance for full year 2024. The Company's updated guidance assumes that the Therakos transaction will close by the end of November and, accordingly, removes approximately $25 million in net sales and approximately $12 million in Adjusted EBITDA that were previously expected to be contributed by Therakos in the month of December. The updated Adjusted EBITDA guidance also reflects approximately $16 million of transaction-related compensation expenses for the sale of Therakos, for a total impact to the Company's full year Adjusted EBITDA of approximately $28 million. The Company's updated guidance is as follows: Mallinckrodt notes that for full year 2024 Therakos is expected to generate approximately $270 million in net sales and approximately $135 million in Adjusted EBITDA. The Company does not provide the comparable GAAP measures for its forward-looking non-GAAP guidance or a reconciliation of such measures because the reconciling items described in the definition of Adjusted EBITDA provided below are inherently uncertain and difficult to estimate and cannot be predicted without unreasonable effort. The variability of such items may have a significant impact on our future GAAP results. Conference Call and Webcast Mallinckrodt will hold a conference call today, November 5, 2024, at 8:30 a.m. Eastern Time to discuss its financial results and performance for the third quarter 2024. The live call and subsequent replay can be accessed as follows: Live Call Participant Registration (including dial-in): Audio Only Webcast Link (live and replay): At the Mallinckrodt website: About Mallinckrodt Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The Company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit . Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the Company in advance of or in lieu of distributing a press release or a filing with the SEC disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website. NON-GAAP FINANCIAL MEASURES This press release contains financial measures, including Adjusted EBITDA, adjusted gross profit, adjusted selling, general, and administrative ("SG&A") expenses, adjusted research and development ("R&D") expenses, net sales growth (loss) on a constant-currency basis, and net debt, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. Adjusted EBITDA represents net income or loss prepared in accordance with accounting principles generally accepted in the U.S. ("GAAP") and adjusted for certain items that management believes are not reflective of the operational performance of the business. Adjustments to GAAP amounts include, as applicable to each measure, interest expense, net; income taxes; depreciation; amortization from intangible assets and right-of use asset resulting from finance leases; restructuring charges, net; non-restructuring impairment charges; inventory step-up expense; discontinued operations; changes in fair value of contingent consideration obligations; significant legal and environmental charges; divestitures; liabilities management and separation costs; gains on debt extinguishment, net; unrealized gain or loss on equity investment; reorganization items, net; share-based compensation; fresh-start inventory related expenses; and other items identified by the Company. The Company has forecasted a full-year 2024 adjusted EBITDA for Therakos, consistent with the Company's calculation of the consolidated Company Adjusted EBITDA. As such, certain amounts that management considers to be non-recurring or non-operational are excluded from these measures because management and the chief operating decision maker evaluate the operating results of the excluding such items. These items may include, but are not limited to, depreciation and amortization, share-based compensation, net restructuring charges, non-restructuring impairment charges and liabilities management and separation costs. Also, Therakos Adjusted EBITDA excludes allocations of intercompany corporate overhead costs and fresh-start inventory related expenses and other items identified by the Company. Adjusted gross profit, adjusted SG&A expenses and adjusted R&D expenses represent amounts prepared in accordance with GAAP, adjusted for certain items that management believes are not reflective of the operational performance of the business. Adjustments to GAAP amounts include, as applicable to each measure, the aforementioned items in the Adjusted EBITDA paragraph. The adjustments for these items are on a pre-tax basis for adjusted gross profit and adjusted SG&A expenses. Segment net sales growth (loss) on a constant-currency basis measures the change in segment net sales between current- and prior-year periods using a constant currency, the exchange rate in effect during the applicable prior-year period. Net debt of $1.2 billion as of September 27, 2024, reflects $1.6 billion in total debt outstanding on a GAAP basis less $410.5 million in cash and cash equivalents (unrestricted cash) on a GAAP basis. The Company has provided these adjusted financial measures because they are used by management, along with financial measures in accordance with GAAP, to evaluate the Company's operating performance and liquidity. In addition, the Company believes that they will be used by investors to measure Mallinckrodt's operating results. Management believes that presenting these adjusted measures provides useful information about the Company's performance across reporting periods on a consistent basis by excluding items that the Company does not believe are indicative of its core operating performance. These adjusted measures should be considered supplemental to and not a substitute for financial information prepared in accordance with GAAP. The Company's definition of these adjusted measures may differ from similarly titled measures used by others. Because adjusted financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management strongly encourages investors to review the Company's unaudited condensed consolidated financial statements and publicly filed reports in their entirety. A reconciliation of certain of these historical adjusted financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release. Further information regarding non-GAAP financial measures can be found on the Investor Relations page of the Company's website. Predecessor and Successor Periods Mallinckrodt's financial results presented in this press release include Successor and Predecessor periods. The Successor period runs for the three and nine months ended September 27, 2024, while the Predecessor period is for the three and nine months ended September 29, 2023. We do not believe that reviewing the results of the Successor period in isolation would be useful in identifying trends in or reaching conclusions regarding our overall operating performance. Management believes that our key performance metrics such as net sales and segment results of operations for the three and nine months ended September 27, 2024 (Successor) provide a meaningful comparison and are useful in identifying current business trends when compared to the three and nine months ended September 29, 2023 (Predecessor). Mallinckrodt's results of operations as reported in its unaudited condensed consolidated financial statements for the Successor and Predecessor periods are in accordance with GAAP. The comparison of the Predecessor and Successor periods for the periods presented here is not in accordance with GAAP. However, the Company believes that the comparison is useful for management and investors to assess Mallinckrodt's ongoing financial and operational performance and trends. CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS Statements in this press release that are not strictly historical, including statements regarding future financial condition and operating results, expected product launches, legal, economic, business, competitive and/or regulatory factors affecting Mallinckrodt's businesses, the ongoing strategic review, and any other statements regarding events or developments Mallinckrodt believes or anticipates will or may occur in the future, may be "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve a number of risks and uncertainties. There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: the parties' ability to satisfy the conditions to the divestiture of the Therakos business, including the ability to complete the divestiture on the anticipated timeline or at all; the potential impact of the divestiture on our businesses and the risk that consummating the divestiture may be more difficult, time-consuming and costly than expected; changes in Mallinckrodt's board of directors, business strategy and performance; Mallinckrodt's initiative to explore a variety of potential divestiture, financing and other transactional opportunities; the exercise of contingent value rights by the Opioid Master Disbursement Trust II (the "Trust"); Mallinckrodt's repurchases of debt securities; the liquidity, results of operations and businesses of Mallinckrodt and its subsidiaries; governmental investigations and inquiries, regulatory actions, and lawsuits, in each case related to Mallinckrodt or its officers; Mallinckrodt's contractual and court-ordered compliance obligations that, if violated, could result in penalties; historical commercialization of opioids, including compliance with and restrictions under the global settlement to resolve all opioid-related claims; matters related to Acthar Gel, including the settlement with governmental parties to resolve certain disputes and compliance with and restrictions under the related corporate integrity agreement; the ability to maintain relationships with Mallinckrodt's suppliers, customers, employees and other third parties following the emergence from the 2023 bankruptcy proceedings, as well as perceptions of the Company's increased performance and credit risks associated with its constrained liquidity position and capital structure; the possibility that Mallinckrodt may be unable to achieve its business and strategic goals even now that the emergence from the 2023 bankruptcy proceedings was successfully consummated; the non-dischargeability of certain claims against Mallinckrodt as part of the bankruptcy process; developing, funding and executing Mallinckrodt's business plan; Mallinckrodt's capital structure since its emergence from the 2023 bankruptcy proceedings; scrutiny from governments, legislative bodies and enforcement agencies related to sales, marketing and pricing practices; pricing pressure on certain of Mallinckrodt's products due to legal changes or changes in insurers' or other payers' reimbursement practices resulting from recent increased public scrutiny of healthcare and pharmaceutical costs; the reimbursement practices of governmental health administration authorities, private health coverage insurers and other third-party payers; complex reporting and payment obligations under the Medicare and Medicaid rebate programs and other governmental purchasing and rebate programs; cost containment efforts of customers, purchasing groups, third-party payers and governmental organizations; changes in or failure to comply with relevant laws and regulations; any undesirable side effects caused by Mallinckrodt's approved and investigational products, which could limit their commercial profile or result in other negative consequences; Mallinckrodt's and its partners' ability to successfully develop, commercialize or launch new products or expand commercial opportunities of existing products, including Acthar Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector and the INOmax Evolve platform; Mallinckrodt's ability to successfully identify or discover additional products or product candidates; Mallinckrodt's ability to navigate price fluctuations; competition; Mallinckrodt's and its partners' ability to protect intellectual property rights, including in relation to ongoing and future litigation; limited clinical trial data for Acthar Gel; the timing, expense and uncertainty associated with clinical studies and related regulatory processes; product liability losses and other litigation liability; material health, safety and environmental liabilities; business development activities or other strategic transactions; attraction and retention of key personnel; the effectiveness of information technology infrastructure, including risks of external attacks or failures; customer concentration; Mallinckrodt's reliance on certain individual products that are material to its financial performance; Mallinckrodt's ability to receive sufficient procurement and production quotas granted by the U.S. Drug Enforcement Administration; complex manufacturing processes; reliance on third-party manufacturers and supply chain providers and related market disruptions; conducting business internationally; Mallinckrodt's ability to achieve expected benefits from prior or future restructuring activities; Mallinckrodt's significant levels of intangible assets and related impairment testing; natural disasters or other catastrophic events; Mallinckrodt's substantial indebtedness and settlement obligation, its ability to generate sufficient cash to reduce its indebtedness and its potential need and ability to incur further indebtedness; restrictions contained in the agreements governing Mallinckrodt's indebtedness and settlement obligation on Mallinckrodt's operations, future financings and use of proceeds; actions taken by third parties, including the Company's creditors, the Trust and other stakeholders; Mallinckrodt's variable rate indebtedness; Mallinckrodt's tax treatment by the Internal Revenue Service under Section 7874 and Section 382 of the Internal Revenue Code of 1986, as amended; future changes to applicable tax laws or the impact of disputes with governmental tax authorities; the impact of Irish laws; the impact on the holders of Mallinckrodt's ordinary shares if Mallinckrodt were to cease to be a reporting company in the United States; the comparability of Mallinckrodt's post-emergence financial results and the projections filed with the Bankruptcy Court; and the lack of comparability of Mallinckrodt's historical financial statements and information contained in its financial statements after the adoption of fresh-start accounting following emergence from the 2023 bankruptcy proceedings. The "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's Annual Report on Form 10-K for the fiscal year ended December 29, 2023, Quarterly Report on Form 10-Q for the quarterly period ended March 29, 2024, Quarterly Report on Form 10-Q for the quarterly period ended June 28, 2024, Quarterly Report on Form 10-Q for the quarterly period ended September 27, 2024 to be filed with the SEC, and other filings with the SEC, which are available from the SEC's website () and Mallinckrodt's (), identify and describe in more detail the risks and uncertainties to which Mallinckrodt's businesses are subject. There may be other risks and uncertainties that we are unable to predict at this time or that we currently do not expect to have a material adverse effect on our business. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. Given these uncertainties, one should not put undue reliance on any forward-looking statements. CONTACTS Investor Relations Derek Belz Vice President, Investor Relations 314-654-3950 [email protected] Media Michael Freitag / Aaron Palash / Aura Reinhard / Catherine Simon Joele Frank, Wilkinson Brimmer Katcher 212-355-4449 Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2024. SOURCE Mallinckrodt plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024年11月5日，武田（TOKYO：4502/NYSE：TAK）发布2024财年上半年（FY2024H1, 截至2024年9月30日的六个月）业绩报告。 核心营业利润率达30.2%，同比增长2.2个百分点。 报告期内，公司全球收入达到23840亿日元（156.34亿美元），同比增长5%（按固定汇率计算，下同）；核心营业利润率达30.2%，同比增长2.2个百分点。 公司上调了全年预测及管理指导，预计全年收入持平或略有增长。 受到仿制药影响，中枢神经系统（CNS）兴奋剂VYVANSE（赖氨酸安非他命）销售大幅下滑，在美国市场下降29%，全球市场下降18%；武田预计VYVANSE的销售将在下半年面临加速的仿制药侵蚀。 武田表示，成长期和新发布的产品组合表现出色，收入同比增长18.7%至11270亿日元（79亿美元），占总营收的47%；这些产品的增长一定程度上对冲了仿制药带来的冲击，使上半年业绩强于预期。 其中，克罗恩病和溃疡性结肠炎药物维得利珠单抗（安吉优/Entyvio）录得4732亿日元（31.03亿美元）；得益于在美国推出了注射笔剂型，Entyvio的整体销售额同比增长10.7%，驱动武田在美国的营收增长10%。 用于治疗遗传性血管性水肿的拉那利尤单抗（达泽优/Takhzyro）销售额同比增长16.7%至1110亿日元（7.28亿美元）。 武田与和黄医药合作的小分子抗癌药呋喹替尼（爱优特/Fruzaqla）录得231亿日元（1.51亿美元），并于9月在日本获批，有望进一步放量。 武田正在聚力投资后期管线项目，针对1型发作性睡病的TAK-861和用于IgA肾炎等自免疾病的mezagitamab（TAK-079）均已启动III期临床试验。 首席执行官Christophe Webe表示，“公司的后期研发项目正持续推进，多个项目在本财年进入III期临床阶段，整体业务和长期前景依然强劲。” 全球医疗情报领导者 解锁隐藏在数据中的商业潜力  关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。 联系我们 投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写 点击阅读原文，解锁完整双语新闻