Mayne Pharma, Inc.

Q3'24 net revenue of $1.07 billion increased 4% as reported, or 3% in constant currency(1), compared to Q3'23. Q3'24 net revenue, excluding COVID-related revenue of ~$120 million in Q3’23 and ~$60 million in Q3’24, increased 11% compared to Q3'23. Q3'24 net loss of $(101) million compared to $(227) million of net loss in Q3'23. Q3'24 Adjusted EBITDA(1) of $163 million increased 55% as reported, or 53% in constant currency, compared to Q3'23. (1) See “Non-GAAP Financial Measures” below and the GAAP to non-GAAP reconciliation provided later in this release. SOMERSET, N.J.--(BUSINESS WIRE)-- Catalent, Inc. (NYSE: CTLT) (“Catalent”), the leader in enabling the development and supply of better treatments for patients worldwide, today announced financial results for the third quarter of fiscal 2024, which ended March 31, 2024. “I am pleased to report that in the fiscal third quarter Catalent returned to growth, including double-digit non-COVID year-on-year revenue growth. We also continued our momentum in both the Biologics segment and the Pharma and Consumer Health segment, which drove an increase in consolidated sequential revenue and adjusted EBITDA margin for the second consecutive quarter, as we continue to make progress toward our near-term margin objectives. Additionally, we achieved record third quarter non-COVID customer wins, and our non-COVID customer wins in the first three quarters of the fiscal year increased double digits over the prior year. This momentum reflects the value of our diverse portfolio to our customers and supports our expectations for continued future growth,” said Alessandro Maselli, President and Chief Executive Officer of Catalent, Inc. Commenting on Catalent’s pending transaction with Novo Holdings A/S (“Novo Holdings”), which is expected to close towards the end of calendar year 2024, subject to customary closing conditions, Mr. Maselli said, “Catalent will remain a leading global service provider to the biotech and pharmaceutical industries following the completion of the transaction with Novo Holdings, a world-class investment firm focused on life sciences. Under private ownership, we will benefit from access to additional capital and resources to provide enhanced service for the benefit of customers and patients. Catalent is a patient-first organization with a mission to develop, manufacture and supply products that help people live better and healthier lives – and this will remain our top priority.” Third Quarter 2024 Consolidated Results Net revenue of $1.07 billion increased 4% as reported, or 3% in constant currency(1), from the $1.04 billion reported for the third quarter a year ago. Overall organic net revenue (i.e., excluding the effect of acquisitions, divestitures, and currency translation) increased by 3% over the same period. Net loss was $(101) million, or $(0.56) per basic and diluted share, compared to net loss of $(227) million, or $(1.26) per basic and diluted share, in the third quarter a year ago. EBITDA from operations(1) was $105 million, an increase of $230 million from the EBITDA (loss) from operations(1) of $(125) million reported in the third quarter a year ago. Third quarter fiscal 2024 Adjusted EBITDA(1) was $163 million, or 15.1% of net revenue, compared to $105 million, or 10.1% of net revenue, in the third quarter a year ago. This represents an increase of 55% as reported and an increase of 53% on a constant-currency basis, compared to the fiscal 2023 period. Adjusted Net Loss(1) was $(10) million, or $(0.06) per diluted share, compared to Adjusted Net Loss(1) of $(17) million, or $(0.09) per diluted share, in the third quarter a year ago. (1) See “Non-GAAP Financial Measures” below and the GAAP to non-GAAP reconciliation provided later in this release. Third Quarter 2024 Segment Review (Dollars in millions) Three Months Ended March 31, Constant Currency 2024 2023 Change % Biologics Net revenue $ 461 $ 475 (3 )% Segment EBITDA 49 6 876 % Segment EBITDA margin 10.6 % 1.1 % Pharma and Consumer Health Net revenue 613 563 8 % Segment EBITDA 153 125 21 % Segment EBITDA margin 24.9 % 22.3 % Inter-segment revenue elimination — (1 ) (75 )% Unallocated costs (97 ) (256 ) 62 % Combined totals Net revenue $ 1,074 $ 1,037 3 % EBITDA (loss) from operations $ 105 $ (125 ) * * Not meaningful Biologics segment 2024 vs. 2023 2024 vs. 2023 Year-Over-Year Change Three Months Ended March 31, Nine Months Ended March 31, Net Revenue Segment EBITDA Net Revenue Segment EBITDA Organic (3) % 876 % (15) % (55) % Constant-currency change (3) % 876 % (15) % (55) % Foreign exchange translation impact on reporting — % 6 % — % — % Total % change (3) % 882 % (15) % (55) % Pharma and Consumer Health segment 2024 vs. 2023 2024 vs. 2023 Year-Over-Year Change Three Months Ended March 31, Nine Months Ended March 31, Net Revenue Segment EBITDA Net Revenue Segment EBITDA Organic 8 % 21 % 3 % (2) % Impact of acquisitions — % — % 2 % 3 % Constant-currency change 8 % 21 % 5 % 1 % Foreign currency translation impact on reporting 1 % 1 % 1 % 2 % Total % change 9 % 22 % 6 % 3 % Segment Net Revenue as a % of Total Net Revenue Three Months Ended March 31, 2024 December 31, 2023 September 30, 2023 June 30, 2023 March 31, 2023 Biologics 43 % 43 % 46 % 38 % 46 % Pharma and Consumer Health 57 % 57 % 54 % 62 % 54 % Net Revenue 100 % 100 % 100 % 100 % 100 % Balance Sheet and Liquidity As of March 31, 2024, Catalent had $4.98 billion in total debt, and $4.82 billion in total debt net of cash, cash equivalents, and marketable securities, compared to $4.78 billion in total net debt as of December 31, 2023. Catalent's total available liquidity as of March 31, 2024 was approximately $1.3 billion. Catalent's ratio of First Lien Debt over LTM Adjusted EBITDA was 4.4x at March 31, 2024. Catalent's senior secured credit agreement requires that this ratio remain below 6.5x. Catalent’s net leverage ratio(1) as of March 31, 2024 was 9.3x, compared to 10.3x at December 31, 2023 and 4.9x as of March 31, 2023. (1) See “Non-GAAP Financial Measures” below and the GAAP to non-GAAP reconciliation provided later in this release. Previously Announced Merger Agreement with Novo Holdings On February 5, 2024, Catalent announced that it entered into a merger agreement pursuant to which Novo Holdings, a leading international life science and health care investor, will acquire Catalent in an all-cash transaction that values Catalent at $16.5 billion on an enterprise value basis. The transaction is expected to close towards the end of calendar year 2024, subject to customary closing conditions, including approval by Catalent stockholders and receipt of required regulatory approvals. The transaction is not subject to any financing contingency. In light of the pending transaction with Novo Holdings, and as is customary during the pendency of such transactions, Catalent will not host an earnings conference call and no longer provides forward-looking guidance. About Catalent, Inc. Catalent, Inc. (NYSE: CTLT), is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,500 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply approximately 70 billion doses of nearly 8,000 products annually. Catalent’s expert workforce of nearly 18,000 includes more than 3,000 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated nearly $4.3 billion in revenue in its 2023 fiscal year. For more information, visit . Non-GAAP Financial Measures Use of EBITDA from operations, Adjusted EBITDA, Adjusted Net Income and Segment EBITDA Management measures operating performance based on consolidated earnings from operations before interest expense, expense (benefit) for income taxes, and depreciation and amortization, adjusted for the income or loss attributable to non-controlling interests (“EBITDA from operations”). EBITDA from operations is not defined under U.S. GAAP, is not a measure of operating income, operating performance, or liquidity presented in accordance with U.S. GAAP, and is subject to important limitations. Catalent believes that the presentation of EBITDA from operations enhances an investor’s understanding of its financial performance. Catalent believes this measure is a useful financial metric to assess its operating performance across periods by excluding certain items that it believes are not representative of its core business and uses this measure for business planning purposes. In addition, given the significant investments that Catalent has made in the past in property, plant and equipment, depreciation and amortization expenses represent a meaningful portion of its cost structure. Catalent believes that EBITDA from operations will provide investors with a useful tool for assessing the comparability between periods of Catalent's ability to generate cash from operations sufficient to pay taxes, to service debt and to undertake capital expenditures because it eliminates depreciation and amortization expense. Catalent presents EBITDA from operations in order to provide supplemental information that it considers relevant for the readers of its consolidated financial statements, and such information is not meant to replace or supersede U.S. GAAP measures. Catalent’s definition of EBITDA from operations may not be the same as similarly titled measures used by other companies. Catalent evaluates the performance of its segments based on segment earnings before non-controlling interest, other (income) expense, impairments, restructuring costs, interest expense, income tax expense (benefit), and depreciation and amortization (“segment EBITDA”). Moreover, under Catalent’s credit agreement, its ability to engage in certain activities, such as incurring certain additional indebtedness, making certain investments and paying certain dividends, is tied to ratios based on Adjusted EBITDA, which is not defined under U.S. GAAP, is not a measure of operating income, operating performance, or liquidity presented in accordance with U.S. GAAP, and is subject to important limitations. Adjusted EBITDA is the covenant compliance measure used in the credit agreement governing debt incurrence and restricted payments. Because not all companies use identical calculations, Catalent’s presentation of Adjusted EBITDA may not be comparable to similarly titled measures of other companies. Management also measures operating performance based on Adjusted Net Income and Adjusted Net Income per share. Adjusted Net Income is not defined under U.S. GAAP, is not a measure of operating income, operating performance, or liquidity presented in accordance with U.S. GAAP and is subject to important limitations. Catalent believes that the presentation of Adjusted Net Income and Adjusted Net Income per share enhances an investor’s understanding of its financial performance. Catalent believes these measures are a useful financial metric to assess its operating performance across periods by excluding certain items that it believes are not representative of its core business and Catalent uses these measures for business planning purposes. Catalent defines Adjusted Net Income as net earnings adjusted for amortization attributable to purchase accounting and adjustments for other cash and non-cash items included in the table below, partially offset by its estimate of the tax effects of such cash and non-cash items. Catalent believes that Adjusted Net Income and Adjusted Net Income per share provides investors with a useful tool for assessing the comparability between periods of its ability to generate cash from operations available to its stockholders. Catalent’s definition of Adjusted Net Income may not be the same as similarly titled measures used by other companies. Adjusted Net Income per share is computed by dividing Adjusted Net Income by the weighted average diluted shares outstanding. The most directly comparable U.S. GAAP measure to EBITDA from operations, Adjusted EBITDA, and Adjusted Net Income is net earnings. Included in this release is a reconciliation of net earnings to EBITDA from operations, Adjusted EBITDA and Adjusted Net Income. Catalent does not provide a reconciliation of forward-looking non-GAAP financial measures to their comparable U.S. GAAP financial measures because it could not do so without unreasonable effort due to the unavailability of the information needed to calculate reconciling items and due to the variability, complexity and limited visibility of the adjusting items that would be excluded from the non-GAAP financial measures in future periods. When planning, forecasting, and analyzing future periods, Catalent does so primarily on a non-GAAP basis without preparing a U.S. GAAP analysis as that would require estimates for various cash and non-cash reconciling items that would be difficult to predict with reasonable accuracy. For example, equity compensation expense would be difficult to estimate because it depends on Catalent’s future hiring and retention needs, as well as the future fair market value of its common stock, all of which are difficult to predict and subject to constant change. It is equally difficult to anticipate the need for or magnitude of a presently unforeseen one-time restructuring expense or the values of end-of-period foreign currency exchange rates. As a result, Catalent does not believe that a U.S. GAAP reconciliation would provide meaningful supplemental information about its outlook. Use of Constant Currency As changes in exchange rates are an important factor in understanding period-to-period comparisons, Catalent believes the presentation of results on a constant-currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant-currency information compares results between periods as if exchange rates had remained constant period over period. Catalent uses results on a constant-currency basis as one measure to evaluate its performance. Catalent calculates constant currency by calculating current-year results using prior-year foreign currency exchange rates. Catalent generally refers to such amounts calculated on a constant-currency basis as excluding the impact of foreign exchange or being on a constant-currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with U.S. GAAP. Results on a constant-currency basis, as Catalent presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with U.S. GAAP. Forward-Looking Statements This release contains both historical and forward-looking statements and guidance. All statements other than statements of historical fact, are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally can be identified by the use of statements that include phrases such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “project,” “predict,” “hope,” “foresee,” “likely,” “may,” “could,” “target,” “will,” “would,” or other words or phrases with similar meanings. Similarly, statements that describe Catalent’s objectives, plans, or goals are, or may be, forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Catalent’s expectations, projections, and guidance. Some of the factors that could cause actual results to differ include, but are not limited to, the following: the completion of Catalent’s closing procedures, including without limitation its evaluation of the effectiveness of its internal controls over financial reporting; Catalent’s ability to resolve productivity issues at three of its manufacturing facilities, the impact of such issues on product made at these facilities, the timing of recovering unproduced batches and resumption of normal activities at these facilities, and the impact of such issues on Catalent’s results of operations and financial condition; the declining demand for various vaccines and treatments for the SARS-Co-V-2 strain of coronavirus and its variants (“COVID-19”) from both patients and governments around the world may affect sales of the COVID-19 products Catalent manufactures; participation in a highly competitive market and increased competition that may adversely affect Catalent’s business; demand for its offerings, which depends in part on its customers’ research and development and the clinical and market success of their products; product and other liability risks that could adversely affect Catalent’s results of operations, financial condition, liquidity and cash flows; failure to comply with existing and future regulatory requirements; failure to provide quality offerings to customers could have an adverse effect on Catalent’s business and subject it to regulatory actions and costly litigation; problems providing the highly exacting and complex services or support required; global economic, political and regulatory risks to Catalent’s operations, including risks from inflation, disruptions to global supply chains, or from the Ukrainian-Russian war; inability to enhance existing or introduce new technology or service offerings in a timely manner; inadequate patents, copyrights, trademarks and other forms of intellectual property protections; fluctuations in the costs, availability, and suitability of the components of the products Catalent manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials; changes in market access or healthcare reimbursement in the United States or internationally; fluctuations in the exchange rate of the U.S. dollar against other currencies; adverse tax legislative or regulatory initiatives or challenges or adjustments to Catalent’s tax positions; loss of key personnel; risks generally associated with information systems; inability to complete any future acquisition or other transaction that may complement or expand its business or divest of non-strategic businesses or assets and difficulties in successfully integrating acquired businesses and realizing anticipated benefits of such acquisitions; risks associated with timely and successfully completing, and correctly anticipating the future demand predicted for, capital expansion projects at existing facilities; offerings and customers’ products that may infringe on the intellectual property rights of third parties; environmental, health, and safety laws and regulations, which could increase costs and restrict operations; labor and employment laws and regulations or labor difficulties, which could increase costs or result in operational disruptions; additional cash contributions required to fund Catalent’s existing pension plans; substantial leverage that may limit its ability to raise additional capital to fund operations and react to changes in the economy or in the industry; exposure to interest-rate risk to the extent of its variable-rate debt preventing it from meeting its obligations under its indebtedness; and the impact of and risks related to impairment losses with respect to goodwill or other assets and the possibility that we may incur additional impairment charges, including at Catalent’s Biomodalities and Consumer Health reporting units. Important risk factors relating to the pending merger of Catalent with an affiliate of Novo Holdings (the “Merger”) that also may cause a difference between actual results and forward-looking statements include, but are not limited to: (i) the completion of the Merger on anticipated terms and timing, including obtaining required Catalent stockholder approval and antitrust and other regulatory approvals and clearances, and the satisfaction of other conditions to the completion of the Merger; (ii) potential litigation relating to the Merger that could be instituted by or against Catalent, Novo Holdings or their respective affiliates, directors or officers, including the effects of any outcomes related thereto; (iii) the risk that disruptions from the Merger will harm Catalent’s business, including current plans and operations; (iv) the ability of Catalent to retain and hire key personnel; (v) potential adverse reactions or changes to business or governmental relationships resulting from the announcement or completion of the Merger; (vi) continued availability of capital and financing and rating agency actions; (vii) legislative, regulatory and economic developments affecting Catalent’s business; (viii) general economic and market developments and conditions; (ix) certain restrictions during the pendency of the Merger that may impact Catalent’s ability to pursue certain business opportunities or strategic transactions; (x) unpredictability and severity of catastrophic events, including but not limited to acts of terrorism, pandemics, outbreaks of war or hostilities, as well as Catalent’s response to any of the aforementioned factors; (xi) significant transaction costs associated with the Merger; (xii) the possibility that the Merger may be more expensive to complete than anticipated, including as a result of unexpected factors or events; (xiii) the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger, including in circumstances requiring Catalent to pay a termination fee or other expenses; (xiv) competitive responses to the Merger; (xv) Catalent’s management response to any of the aforementioned factors; (xvi) the risks and uncertainties pertaining to Catalent’s business, including those set forth in Catalent’s most recent Annual Report on Form 10-K and Catalent’s subsequent Quarterly Reports on Form 10-Q, aas such risk factors may be amended, supplemented or superseded from time to time by other reports filed or furnished by Catalent with the Securities and Exchange Commission (“SEC”); and (xvii) the risks and uncertainties that are described in the definitive proxy statement filed with the SEC on April 15, 2024 (the “Proxy Statement”). These risks, as well as other risks associated with the Merger, are more fully discussed in the Proxy Statement. While the list of factors presented here is, and the list of factors presented in the Proxy Statement is, considered representative, no such list should be considered a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Consequences of material differences in results as compared with those anticipated in the forward-looking statements could include, among other things, actions of governmental authorities, business disruption, operational problems, financial loss, legal liability to third parties and similar risks, any of which could have a material impact on Catalent’s financial condition, results of operations, credit rating or liquidity. These forward-looking statements speak only as of the date of this release or as of the date they are made, and Catalent does not undertake to and specifically disclaims any obligation to publicly release the results of any updates or revisions to these forward-looking statements that may be made to reflect future events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events. Important Information and Where to Find It In connection with the Merger, Catalent has filed with the SEC the Proxy Statement. Catalent may also documents with the SEC regarding the proposed Merger. This release is not a substitute for the Proxy Statement or any other document that Catalent may the SEC. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS THAT ARE FILED OR WILL BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER AND RELATED MATTERS. Investors and security holders may obtain free copies of the Proxy Statement and other documents that are filed or will be filed with the SEC by Catalent through the website maintained by the SEC at , Catalent’s website at or by contacting Catalent’s Investor Relations Team at: Catalent, Inc., Investor Relations 14 Schoolhouse Road Somerset, New Jersey 08873 investors@catalent.com (732) 537-6325 Participants in the Solicitation Catalent and certain of its directors, executive officers and other employees may be deemed to be participants in the solicitation of proxies from Catalent’s stockholders in connection with the proposed Merger. Additional information regarding the identity of the participants, including a description of their direct or indirect interests, by security holdings or otherwise, are or will be set forth in the Proxy Statement and other materials filed with the SEC in connection with the proposed Merger. Information relating to the foregoing can also be found in Catalent’s proxy statement for its 2023 annual meeting of stockholders, which was filed with the SEC on December 15, 2023 (the “Annual Meeting Proxy Statement”). To the extent holdings of securities by potential participants (or the identity of such participants) have changed since the information printed in the Annual Meeting Proxy Statement, such information has been or will be reflected on Catalent’s Statements of Change in Ownership on Forms 3 and 4 filed with the SEC. You may obtain free copies of these documents using the sources indicated above. More products. Better treatments. Reliably supplied.™ Catalent, Inc. Consolidated Statements of Operations (Unaudited; dollars and shares in millions, except per share data) Three Months Ended March 31, FX Impact Constant Currency Increase (Decrease) 2024 2023 Change $ Change % Net revenue $ 1,074 $ 1,037 $ 5 $ 32 3 % Cost of sales 845 857 2 (14 ) (2 )% Gross margin 229 180 3 46 26 % Selling, general, and administrative expenses 214 190 — 24 12 % Goodwill impairment adjustments — 210 — (210 ) (100 )% Other operating expense, net 32 15 (1 ) 18 147 % Operating loss (17 ) (235 ) 4 214 91 % Interest expense, net 65 51 — 14 28 % Other expense (income), net 4 (4 ) 3 5 132 % Loss before income taxes (86 ) (282 ) 1 195 69 % Income tax expense (benefit) 15 (55 ) — 70 126 % Net loss $ (101 ) $ (227 ) $ 1 $ 125 55 % Weighted average shares outstanding – basic 182 181 Weighted average shares outstanding – diluted 182 181 Earnings (loss) per share: Basic Net loss $ (0.56 ) $ (1.26 ) Diluted Net loss $ (0.56 ) $ (1.26 ) * Not meaningful Catalent, Inc. Consolidated Statements of Operations (Unaudited; dollars and shares in millions, except per share data) Nine Months Ended March 31, FX impact Constant Currency Increase (Decrease) 2024 2023 Change $ Change % Net revenue $ 3,080 $ 3,208 $ 38 $ (166 ) (5 )% Cost of sales 2,511 2,383 28 100 4 % Gross margin 569 825 10 (266 ) (32 )% Selling, general and administrative expenses 669 612 4 53 9 % Goodwill impairment charges 687 210 — 477 * Other operating expense 68 40 (1 ) 29 73 % Operating loss (855 ) (37 ) 7 (825 ) * Interest expense, net 189 130 — 59 45 % Other expense (income), net 21 (2 ) 5 18 * Loss before taxes (1,065 ) (165 ) 2 (902 ) * Income tax expense (benefit) 1 (19 ) 2 18 96 % Net loss $ (1,066 ) $ (146 ) $ — $ (920 ) * Weighted average shares outstanding – basic 181 180 Weighted average shares outstanding – diluted 181 180 Earnings (loss) per share: Basic Net loss $ (5.87 ) $ (0.81 ) Diluted Net loss $ (5.87 ) $ (0.81 ) Catalent, Inc. Condensed Consolidated Balance Sheets (Unaudited; dollars in millions) March 31, 2024 June 30, 2023 ASSETS Current assets: Cash and cash equivalents $ 162 $ 280 Trade receivables, net 875 1,002 Inventories 742 777 Prepaid expenses and other 744 633 Total current assets 2,523 2,692 Property, plant, and equipment, net 3,735 3,682 Other non-current assets, including intangible assets 3,621 4,403 Total assets $ 9,879 $ 10,777 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Current portion of long-term obligations and other short-term borrowings $ 47 $ 536 Accounts payable 377 424 Other accrued liabilities 583 570 Total current liabilities 1,007 1,530 Long-term obligations, less current portion 4,933 4,313 Other non-current liabilities 328 323 Total shareholders' equity 3,611 4,611 Total liabilities and shareholders' equity $ 9,879 $ 10,777 Catalent, Inc. Condensed Consolidated Statements of Cash Flows (Unaudited; dollars in millions) Nine Months Ended March 31, 2024 2023 CASH FLOWS FROM OPERATING ACTIVITIES: Net cash provided by operating activities $ 54 $ 58 CASH FLOWS FROM INVESTING ACTIVITIES: Acquisition of property, equipment, and other productive assets (252 ) (455 ) Proceeds from maturity of marketable securities — 89 Proceeds from sale of property and equipment 1 8 Payment for acquisitions, net of cash acquired — (474 ) Payment for investments (2 ) (2 ) Net cash used in investing activities (253 ) (834 ) CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from borrowing 1,060 715 Payments related to long-term obligations (971 ) (176 ) Financing fees paid (16 ) (4 ) Exercise of stock options 9 4 Other financing activities 2 33 Net cash provided by financing activities 84 572 Effect of foreign currency exchange on cash and cash equivalents (3 ) 7 NET DECREASE IN CASH AND CASH EQUIVALENTS (118 ) (197 ) CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 280 449 CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 162 $ 252 Catalent, Inc. Reconciliation of Net Earnings (Loss) to EBITDA from Operations and Adjusted EBITDA* (Unaudited; dollars in millions) Three months ended March 31, 2023 June 30, 2023 September 30, 2023 December 31, 2023 March 31, 2024 Net loss $ (227 ) $ (110 ) $ (759 ) $ (206 ) $ (101 ) Interest expense, net 51 56 58 66 65 Income tax expense (benefit) (55 ) (67 ) (38 ) 24 15 Depreciation and amortization 106 114 112 121 126 EBITDA (loss) from operations (125 ) (7 ) (627 ) 5 105 Goodwill impairment charges (adjustments) 210 — 689 (2 ) — Stock-based compensation 6 — 19 16 17 Impairment charges and gain/loss on sale of assets 6 93 (1 ) 15 13 Restructuring costs 9 30 2 17 11 Acquisition, integration, and other special items 8 9 7 11 — Foreign exchange (gain) loss (8 ) (4 ) 9 2 (1 ) Site transformation costs — — 14 16 7 Pension settlement charges — — — 3 9 Impacts from COVID-19 contract settlement — — — 24 — Fire loss contingency — — — 9 — Other adjustments (1 ) 1 — 7 2 Adjusted EBITDA $ 105 $ 122 $ 112 $ 123 $ 163 Favorable (unfavorable) FX impact 2 Adjusted EBITDA at constant currency $ 161 * Refer to Catalent's description of non-GAAP measures, including EBITDA from operations and Adjusted EBITDA as referenced above. Catalent, Inc. Reconciliation of Net Loss to Adjusted Net (Loss) Income* (Unaudited; dollars in millions, except per share data) Three months ended March 31, 2023 June 30, 2023 September 30, 2023 December 31, 2023 March 31, 2024 Net loss $ (227 ) $ (110 ) $ (759 ) $ (206 ) $ (101 ) Amortization (1) 34 35 34 33 34 Goodwill impairment charges (adjustments) (2) 210 — 689 (2 ) — Stock-based compensation 6 — 19 16 17 Impairment charges and gain/loss on sale of assets (3) 6 93 (1 ) 15 13 Restructuring costs (4) 9 30 2 17 11 Acquisition, integration, and other special items (5) 8 9 7 11 — Foreign exchange (gain) loss (8 ) (4 ) 9 2 (1 ) Site transformation costs (6) — — 14 16 7 Pension settlement charges (7) — — — 3 9 Impacts from COVID-19 contract settlement (8) — — — 24 — Fire loss contingency (9) — — — 9 — Other adjustments (10) — — (1 ) 7 1 Estimated tax effect of adjustments (11) (12 ) (83 ) (21 ) 13 — Discrete income tax benefit items (12) (43 ) 31 (16 ) (3 ) — Adjusted net (loss) income (ANI) $ (17 ) $ 1 $ (24 ) $ (45 ) $ (10 ) Weighted average shares outstanding – basic 181 182 Weighted average shares outstanding – diluted 181 182 Earnings per share: Net loss per share – basic $ (1.26 ) $ (0.56 ) Net loss per share – diluted $ (1.26 ) $ (0.56 ) ANI per share: ANI (loss) per share – basic $ (0.09 ) $ (0.06 ) ANI (loss) per share – diluted (13) $ (0.09 ) $ (0.06 ) * Refer to Catalent's description of non-GAAP measures, including Adjusted Net Income (Loss) as referenced above. (1) Represents the amortization attributable to purchase accounting for previously completed business combinations. (2) Non-cash goodwill impairment charges during the three months ended March 31, 2023 were associated with the Company's Consumer Health reporting unit. Non-cash goodwill impairment charges during the three months ended September 30, 2023 were associated with the Company's Biomodalities and Consumer Health reporting units. (3) For the three months ended June 30, 2023, represents fixed asset impairment charges primarily associated with an idle facility in the Biologics segment. Impairment charges and gain/loss on sale of assets for the three months ended December 31, 2023 and for the three months ended March 31, 2024 includes fixed asset impairment charges associated with equipment for a product with significant decline demand in the Company's Biologics segment. (4) Restructuring costs represent employee and non-employee restructuring charges associated with Catalent's plans to reduce costs, consolidate facilities, and optimize its infrastructure across the organization. (5) Acquisition, integration and other special items include costs associated with its October 2022 acquisition of Metrics Contract Services. (6) Represents operational and engineering enhancements and costs related to a transformation program in our Biologics segment. (7) Represents the loss on settlement of a frozen domestic qualified pension plan. (8) For the three months ended December 31, 2023, represents one-time inventory charges for the settlement of a COVID-19 agreement where revenue from the settlement was deferred into future periods, a majority of which is expected within fiscal year 2024. (9) For the three months ended December 31, 2023, represents one-time loss contingency accruals for inventory and damages sustained from a fire at a facility in our Biologics segment. (10) For the three months ended December 31, 2023, primarily represents one-time charges of penalties and interest on a value-added tax settlement in Western Europe. (11) The tax effect of adjustments to Adjusted Net (Loss) Income is computed by applying the statutory tax rate in the jurisdictions to the income or expense items that are adjusted in the period presented; if a valuation allowance exists, the rate applied is zero. (12) Discrete period income tax expense items are unusual or infrequently occurring items, primarily including: changes in judgment related to the realizability of deferred tax assets in future years, changes in measurement of a prior-year tax position, deferred tax impact of changes in tax law, and purchase accounting. (13) For the three months ended March 31, 2024 and 2023, represents Adjusted Net (Loss) Income divided by the weighted average sum of fully diluted shares outstanding, which is equal to (a) the number of shares of common stock outstanding, plus (b) the number of shares of its common stock that would be issued assuming exercise or vesting of all potentially dilutive instruments. For the three months ended March 31, 2024 and 2023, the weighted average number of shares was 182 million and 181 million, respectively. Catalent, Inc. Reconciliation of Segment EBITDA to Net (Loss) Earnings (Unaudited; dollars in millions, except per share data) Three Months Ended March 31, Nine Months Ended March 31, 2024 2023 2024 2023 Biologics Segment EBITDA $ 49 $ 6 $ 136 $ 299 Pharma and Consumer Health Segment EBITDA 153 125 380 368 Sub-Total $ 202 $ 131 $ 516 $ 667 Reconciling items to net loss Unallocated costs (1) (97 ) (256 ) (1,033 ) (394 ) Depreciation and amortization (126 ) (106 ) (359 ) (308 ) Interest expense, net (65 ) (51 ) (189 ) (130 ) Income tax expense (15 ) 55 (1 ) 19 Net loss $ (101 ) $ (227 ) $ (1,066 ) $ (146 ) (1) Unallocated costs include restructuring and special items, stock-based compensation, impairment charges, gain on sale of subsidiary, certain other corporate directed costs, and other costs that are not allocated to the segments. Catalent, Inc. Calculation of Net Leverage Ratio (Unaudited; dollars in millions) March 31, 2023 June 30, 2023 September 30, 2023 December 31, 2023 March 31, 2024 Incremental Term Loan B-3, due 2028 $ 1,422 $ 1,418 $ 1,415 $ 1,411 $ 1,408 Incremental Term Loan B-4, due 2028 — — — 600 600 Revolving credit facility 550 500 585 — — Unamortized discount and debt issuance costs (12 ) (11 ) (12 ) (25 ) (24 ) Total Secured Debt 1,960 1,907 1,988 1,986 1,984 Senior Notes, due 2027, 5.000% 500 500 500 500 500 Senior Notes, due 2028 (EUR), 2.375% 895 904 872 910 893 Senior Notes, due 2029, 3.125% 550 550 550 550 550 Senior Notes due 2030, 3.500% 650 650 650 650 650 Finance Leases / Other 323 366 412 434 426 Unamortized discount and debt issuance costs (29 ) (28 ) (26 ) (25 ) (23 ) Total Unsecured Debt 2,889 2,942 2,958 3,019 2,996 Total Debt 4,849 4,849 4,946 5,005 4,980 Cash and Cash Equivalents 252 280 209 229 162 Total Net Debt $ 4,597 $ 4,569 $ 4,737 $ 4,776 $ 4,818 Adjusted EBITDA Q4 2022 358 Q1 2023 187 187 Q2 2023 283 283 283 Q3 2023 105 105 105 105 Q4 2023 122 122 122 122 Q1 2024 112 112 112 Q2 2024 123 123 Q3 2024 163 LTM Adjusted EBITDA $ 933 $ 697 $ 622 $ 462 $ 520 First Lien Debt / Adj. EBITDA 2.2x 2.9x 3.5x 4.8x 4.4x Net Debt / Adj. EBITDA 4.9x 6.6x 7.6x 10.3x 9.3x View source version on businesswire.com: Contacts Investor Contact: Catalent, Inc. Paul Surdez 732-537-6325 investors@catalent.com Source: Catalent, Inc. View this news release online at:

编者按：本文来自药智头条，作者葵花籽；赛柏蓝授权转载，编辑yuki“专利悬崖”意指药品专利保护期届满后，其销售额与利润大幅下滑的现象。此种现象如同一道无形的悬崖，原研药即便在光辉成就之下，亦无法回避这一严峻现实。对于原研药企而言，在寻求新增长点与巩固专利“护城河”的过程中，均面临着诸多挑战。利拉鲁肽、达沙替尼、那他珠单抗等多款年销售额超5亿美元的大品种都将在今年先后失去美国专利保护。2024年在美专利到期的十大药物资料来源：Fierce Pharma01 达沙替尼（Sprycel）适应症：慢性粒细胞白血病研发企业：BMS2023年美国销售额：14.5亿美元生物类似药上市时间：2024年9月达沙替尼是百时美施贵宝（BMS）肿瘤学主打产品之一，是一种针对癌细胞中特定蛋白质并阻止癌细胞生长的药物。BMS财报显示，达沙替尼2023年全球销售额约为19.3亿美元，其中14.5亿美元来自美国市场。达沙替尼于2006年首次获FDA批准，用于对先前治疗药物（包括伊马替尼）具有耐药性或不耐受的费城染色体阳性慢性髓系白血病慢性期（Ph+CML-CP）成人患者以及用于对先前治疗药物具有耐药性或不耐受的Ph+ALL成人患者。BMS在一份年度证券文件中解释说，由于与Apotex和一些未披露名称的公司达成了和解协议，某些仿制药获准在2024年9月上市，或在某些情况下提前上市。据悉，目前Teva、Biocon、Lupin、Dr.Reddy's Laboratories、Alebmic的仿制药已获得FDA暂定批准。02那他珠单抗（Tysabri）适应症： 多发性硬化症、克罗恩病研发企业：渤健2023年美国销售额：9.98亿美元生物类似药上市时间：2024年下半年那他珠单抗于2004年获得FDA批准用于治疗多发性硬化症，2008年获批用于治疗克罗恩病。该药在2009年销售额高达11亿美元。根据渤健2023年第四季度财报，2023年该药在美国的销售额为9.98亿美元，较2022年的11.2亿美元下降约11%。在特拉华州联邦法院驳回百健对山德士的专利侵权诉讼约两个月后，山德士于2023年8月获得了美国首个、也是迄今为止唯一一个那他珠单抗生物类似药的批准。03米拉贝隆（Myrbetriq）适应症：膀胱过度活动症研发企业：安斯泰来2023年美国销售额：6.4亿美元生物类似药上市时间：2024年5月2012年6月，米拉贝隆在美国获批上市。2023年6月，美国特拉华州地区法院作出裁决，宣布该药2030年的一项关键专利无效，这促使安斯泰来公开回应，并强调该药在2024年5月前仍受专利保护。不久之后，安斯泰来又获得了一项2030年的膀胱过度活动症药物专利，并发起了新一轮针对仿制药公司的诉讼。安斯泰来寻求获得FDA禁令，禁止生物类似药在该专利到期前上市。FDA的桔皮书显示，米拉贝隆的监管专属期将于2024年9月到期。该药的部分专利将于2024年5月到期。与此同时，Lupin和Alkem两家公司的米拉贝隆仿制药已获得FDA批准，此外，Aurobindo的仿制药也获得了初步批准。04利拉鲁肽（Victoza）适应症：2型糖尿病研发企业：诺和诺德2023年美国销售额：5.25亿美元生物类似药上市时间：2024年6月作为诺和诺德第一代GLP-1糖尿病药物，利拉鲁肽自2010年获批以来已顺利享受了14年的独占期，包括将其专利悬崖延长至2024年的儿科独占期。目前，生物类似药竞争者Teva、山德士和晖致正急于蚕食利拉鲁肽已经日薄西山的销售额。根据诺和诺德2023年年度报告，2023年利拉鲁肽在美国的销售额为5.25亿美元，较2022年9.3亿美元大幅下降。根据美国证券交易委员会的一份文件，Teva、山德士和晖致为主要的仿制药公司。其中，Teva计划在2024年6月推出利拉鲁肽生物类似药。05Emflaza (deflazacort)适应症： 杜氏肌营养不良症研发企业：PTC Therapeutics2023年美国销售额：2.55 亿美元生物类似药上市时间：2024年2月在经历了之前的定价争议之后，PTC Therapeutics获批治疗杜氏肌营养不良症（DMD）的关键药物Emflaza已经面临着新的生物类似药竞争。印度Aurobindo公司在2024年2月获得FDA最终批准后，正在计划推出Emflaza生物类似药，该药的标签范围涵盖了5岁及以上患者。06注射用醋酸奥曲肽微球 (Sandostatin LAR) 适应症：肢端肥大症，类癌瘤引起的严重腹泻研发企业： 诺华2023年美国销售额：1.99 亿美元仿制药上市时间：2024年Sandostatin LAR于1998年首次获得FDA批准治疗肢端肥大症，还可用于治疗转移性类癌引起的严重腹泻和潮红。晖致总裁Rajiv Malik在今年1月举行的摩根大通医疗保健会议上表示，将Sandostatin LAR列为今年计划推出的仿制药之一。根据晖致最新消息，Sandostatin LAR仿制药申请正在接受FDA审查。虽然Sandostatin LAR此前一直保持着美国的独家经营权，但其销售额已逐年大幅下降。去年Sandostatin在美国的销售额为1.99亿美元，同比下降2%。07Dulera (糠酸莫米松+福莫特罗)适应症： 哮喘研发企业：欧加隆2023年美国销售额：1.56 亿美元仿制药上市时间：2024年下半年Dulera是一款皮质类固醇糠酸莫米松和长效β受体激动剂福莫特罗的复方制剂，通过吸入器给药。Dulera曾被视为潜在的“重磅炸弹”，2010年获批用于治疗哮喘，但2012年治疗慢性阻塞性肺病（COPD）的第二次申请遭 FDA拒批。尽管获批折戟，但其销售额仍呈上升趋势，2015年达到5.36亿美元的峰值。到2017年，由于价格竞争压力以及需求下降，Dulera的销售额缩水至2.87亿美元。2023年更是骤降至1.56亿美元。Dulera已于2020年失去了在美国的专利保护，但至今未有相关仿制药上市。印度仿制药巨头Lupin曾于2020年4月向FDA递交了Dulera仿制药的上市申请，但其申请在2022年底被FDA拒绝批准。上个月，该公司表示将在2024年5月之前对FDA的决定做出回应。08奥卡西平 (Oxtellar XR）适应症： 癫痫研发企业：Supernus Pharmaceuticals2023年美国销售额：1.13 亿美元仿制药上市时间：2024年9月2012年，奥卡西平作为辅助疗法获得批准后销售额逐年攀升；2019年，奥卡西平作为单药疗法获批，销售额继续增长，2021年首次突破1亿美元，2023年在美国的销售额为1.13亿美元。十年前，Actavis和TWi Pharma首次对奥卡西平发出仿制药挑战。Supernus分别于2017年和2018年在针对仿制药生产商的侵权案中胜诉，因为法院判决其专利期有效至2027年。奥卡西平失去专利保护对其的影响并不大。在2月份的季度电话会议上，Supernus首席执行官Jack Khattar表示，预计仿制药竞争要到9月份才会开始。2024年奥卡西平和Trokendi XR的合并净销售额将在1.25亿美元到1.35亿美元之间。09Venofer (蔗糖铁)适应症：慢性肾病患者缺铁性贫血研发企业：CSL2023年美国销售额：0.9亿美元仿制药上市时间：2024年Venofer于2000年获得FDA批准用于治疗慢性肾病成人患者的缺铁性贫血。多年来，Venofer一直在回击潜在的仿制药挑战者。晖致在2月的投资者推介会上称其Venofer仿制药正在接受监管审查。CSL在2021年底以117亿美元收购Vifor Pharma时获得该药，据CSL投资者报告，该药物2023年的全球销售额为1.8亿美元，预计其中二分之一来自美国市场。10Prolensa (bromfenac)适应症：白内障手术后的术后眼部炎症研发企业：Bausch + Lomb2023年美国销售额：0.415亿美元仿制药上市时间：2024年1月FDA于2013年批准Bausch+Lomb的Prolensa滴眼液作为白内障手术患者术后炎症的治疗药物，但它并不是第一款进入美国市场的含有非甾体抗炎药物溴芬酸活性成分的滴眼液产品。Prolensa最初是由日本公司Senju开发，2000年在日本上市。ISTA公司于 2002年获得该药在美国的使用权，ISTA后来被Bausch+Lomb收购。2005年，该产品在美国获批上市，商品名为Xibrom（溴芬酸0.09%），作为白内障手术后眼部炎症的每日2次滴眼液选择。2010年，ISTA开发的溴芬酸的每日1次滴眼液版本Bromday获批上市。在Prolensa获得FDA批准的同一年，Lupin曾向FDA提交溴芬酸的仿制药上市申请。经历了长达近3年的诉讼后，Lupin仿制药于2023年11月获得FDA 批准。除了Lupin之外，Metrics、Innopharma、Apotex和Paddock也向FDA提交了Prolensa的仿制药上市申请。END内容沟通：13810174402医药代表交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

众所周知，一款药品是存在生命周期的，一旦其专利期到期，便会面临来自仿制药或生物类似药的威胁，导致其销售额出现下滑。这也是众多药企选择多线布局以避免过分依靠一款产品来支撑整体收入的重要原因之一。修美乐（阿达木单抗）是近期的典型例子。2023年，修美乐正式失去市场独占权，接受来自安进、三星生物、山德士（Sandoz）等十家公司的阿达木单抗生物类似药产品的竞争。据艾伯维财报，2023年修美乐全球销售额约为144亿美元，同比下滑32%。2024年，同样有多款产品将在美国失去市场独占权，如下表所示。2024年失去美国独家经营权的十款产品注：销售额单位为亿美元药品：达沙替尼（Sprycel）适应症：慢性粒细胞白血病公司：BMS达沙替尼是慢性粒细胞白血病（CML）领域近20年来的创新药物，为这类患者提供了显著提高其生存率的可能。根据BMS最近的一份收益报告，2023年达沙替尼的全球销售额约为19.3亿美元，其中14.5亿美元来自美国市场。BMS曾就达沙替尼的专利纠纷进行过多次诉讼。近期，BMS在一份年度证券文件中表示，由于与Apotex以及其他公司达成和解协议，这些公司的达沙替尼仿制药被允许在2024年9月或“在某些情况下更早”上市。到目前为止，Biocon、Lupin、Dr. Reddy's Laboratories、Alebmic和Teva的达沙替尼均已获得FDA批准。除了仿制药之外，Sprycel也面临来自剂型创新产品的威胁。例如Xspray Pharma开发了达沙替尼定形固体分散体片剂（XS004，商品名Dasynoc），该产品与Sprycel具有生物等效性，但其剂量比Sprycel低30%。Xspray Pharma表示，XS004可以通过降低剂量来减少药物副作用。FDA已于今年2月受理XS004的上市申请，并将其PDUFA日期定为2024年7月31日。药品：那他珠单抗（Tysabri）适应症： 多发性硬化症、克罗恩病公司：Biogen那他珠单抗最初于2004年被FDA批准用于治疗多发性硬化症，并在2008年扩大适应症至克罗恩病。第二年，该药物的销售额达到了11亿美元，跻身重磅炸弹药物。根据Biogen财报，2023年该药物在美国的销售额为9.98亿美元。目前，美国仅有山德士的那他珠单抗生物类似药PB006（商品名Tyruko）获批上市。在2023年Q3财报发布会上，山德士透露计划于2024年上半年在美国和欧洲市场推出Tyruko。药品：米拉贝隆（Myrbetriq）适应症：膀胱过度活动症公司：安斯泰来米拉贝隆于2012年6月在美国获批上市。FDA的橙皮书显示，米拉贝隆的监管排他期将于2024年9月到期，其部分专利将于2024年5月到期。根据安斯泰来的财务报告，Myrbetriq在2023年的美国销售额为964亿日元（约合6.4亿美元）。目前，Lupin和Alkem的米拉贝隆仿制药已经获得了FDA的批准，而Aurobindo的仿制产品也已申报上市。在2023年财报发布会上，Lupin首席执行官Vinita Gupta表示将在今年4-6月推出该产品。药品：利拉鲁肽（Victoza）适应症：2型糖尿病公司：诺和诺德利拉鲁肽是诺和诺德推出的第一代GLP-1产品，该产品于2010年1月在美国获批上市。自2014年以来，利拉鲁肽虽然面临来自度拉糖肽（Trulicity）的竞争，但是仍然每年为诺和诺德创造了几十亿美元的收入。2023年，该产品的美国销售额约为5.25亿美元。目前，Teva、山德士和晖致（Viatris）等公司已对利拉鲁肽所占有的市场虎视眈眈。其中Teva计划在2024年6月将其产品推进市场。与此同时，山德士的利拉鲁肽生物类似药也被允许在今年6月22日之前或者“在某些情况下更早”上市。晖致表示，希望在与诺和诺德达成和解后在6月推出其产品。不过，诺和诺德早已推出了第二代GLP-1产品——司美格鲁肽。该产品正在糖尿病和肥胖市场势如破竹，2023年Ozempic的美国销售额约为Victoza的17倍。药品：Deflazacort（Emflaza）疾病：杜氏肌营养不良症公司：EmflazaDeflazacort是PTC Therapeutics于2017年2月在美国推出的杜氏肌营养不良症（DMD）治疗药物。根据PTC财报，2023年Emflaza在美国的销售额为2.55亿美元。就Deflazacort而言，PTC拥有的专利和监管排他性已经基本耗尽仅剩一个排他性尚未到期——2-5岁DMD患者，该排他性将于2026年到期。印度公司Aurobindo的Deflazacort仿制药已在今年2月获得FDA批准，适用人群为5岁以上DMD患者。药品：奥曲肽（Sandostatin）适应症：肢端肥大症，类癌瘤引起的严重腹泻公司：诺华奥曲肽早在1988年便已在美国上市。但是，诺华后来推出了复杂剂型版本Sandostatin LAR，极大地延长了该产品的生命周期。诺华首席财务官Harry Kirsch在2023年财报发布会上表示，Sandostatin LAR是一种非常难以生产的产品，对仿制药生产商的生产能力要求极高。这便是多年来奥曲肽的市场地位无法被撼动的关键原因。不过，今年晖致希望改变这种状况。晖致总裁Rajiv Malik在1月份的JP摩根大会上表示，将在今年推出Sandostatin LAR的仿制药。目前其仿制药的上市申请正在接受FDA的审查。虽然Sandostatin LAR此前一直保持着美国的独家经营权，但其销售额已逐年大幅下降。去年Sandostatin在美国的销售额为1.99亿美元，同比下降2%。药品：糠酸莫米松+福莫特罗（Dulera）适应症：哮喘公司：OrganonDulera曾被认为是潜在的重磅炸弹，于2010年在美国获批用于治疗哮喘。不过，其慢性阻塞性肺病（COPD）适应症未能获批，导致其市场空间被压缩。2015年，该产品的全球销售额达到了5.36亿美元。然而，来自葛兰素史克（GSK）的竞品Breo（糠酸氟替卡松+维兰特罗）加入了市场竞争，凭借哮喘和COPD两大适应症成为了轰动一时的药物。不过，去年Dulera的全球销售额有所回升，约为1.94亿美元，同比增长8%。Dulera已于2020年失去了在美国的专利保护，但至今未有相关仿制药上市。印度仿制药巨头Lupin曾于2020年4月向FDA递交了Dulera仿制药的上市申请，但其申请在2022年底被FDA拒绝批准。上个月，该公司表示将在2024年5月之前对FDA的决定做出回应。药品：奥卡西平缓释片（Oxtellar XR）适应症：癫痫公司：Supernus奥卡西平缓释片（Oxtellar XR）是Supernus推出的抗癫痫药物，于2012年被批准为癫痫患者的辅助疗法。不过，其销售表现平平，在被批准为单药疗法后三年其年销售额才达到1亿美元。2023年，该产品的销售额也仅为1.134亿美元。因而，失去Oxtellar XR的专利保护对Supernus的业绩影响并不大。在2月份的2023年财报发布会上，Supernus首席执行官Jack Kattar表示，奥卡西平缓释片的仿制药可能要到9月才开始加入市场竞争。Oxtellar XR第一次面临仿制药的威胁是在近十年前。当时，Actavis和TWi Pharma与Supernus均展开了专利诉讼，最后Supernus胜诉，Oxtellar XR的专利保护期得以维持到2027年。然而，Supernus在2020年与Apotex在侵权案件中败诉。去年6月，Supernus不得不与Apotex达成和解，同意后者于今年9月1日开始销售奥卡西平缓释片的仿制产品。该仿制药已于去年7月获FDA批准上市。在与Apotex达成和解之前，Supernus还对RiconPharma提起过诉讼，最终Supernus也未胜诉。Supernus的另一款抗癫痫药物托吡酯缓释片（Trokendi XR）也于2023年遭受了仿制药的冲击。为缓解这两款抗癫痫产品到达专利悬崖的难题，Supernus在2021年以4亿美元收购了Adamas，获得了治疗左旋多巴诱导运动障碍以及多发性硬化症行走障碍的Gocovri以及用于左旋多巴诱导运动障碍的Osmolex。其中，Gocovri在2023年为创造了1.2亿美元的收入。药品：蔗糖铁（Venofer）适应症：慢性肾病患者缺铁性贫血公司：CSL蔗糖铁是CSL在2021年底以117亿美元收购Vifor Pharma时获得的产品之一。根据CSL的投资者报告，该药物在2023年的全球销售额为1.8亿美元。CSL未按地域统计药物收入，不过，按以往表现可推测其美国销售额约为0.9亿美元。与奥曲肽类似，蔗糖铁的专利早已过期，但因制剂复杂性而获得了较长时间的市场独占期。晖致亦相信可以在2024年改变这种状况。目前，该公司开发的蔗糖铁仿制药正在接受FDA的监管审查，有望成为首款蔗糖铁仿制药。药品：溴芬酸（Prolensa）适应症：白内障手术后的术后眼部炎症公司：Bausch+Lomb溴芬酸最初由日本公司Senju开发，并于2000年在日本上市。其美国权益于2002年被ISTA（现已被Bausch+Lomb收购）收入囊中。三年后，该产品在美国获批上市，商品名为Xibrom（溴芬酸0.09%），作为白内障手术后眼部炎症的每日2次滴眼液选择。2010年，ISTA开发的溴芬酸的每日1次滴眼液版本Bromday获批上市。2013年，溴芬酸的另一款每日1次滴眼液版本Prolensa（溴芬酸0.07%）获批上市。根据美国证券交易委员会（SEC）的一份年度文件，去年Prolensa的销售额约占Bausch+Lomb整体收入的1%。在Prolensa获得FDA批准的同一年，Lupin曾向FDA提交溴芬酸的仿制药上市申请，但被Bausch+Lomb和Senju起诉，引发了30个月的中止期，阻止了Lupin仿制药的批准。去年11月，该仿制药终于获FDA批准。除了Lupin之外，Metrics、Innopharma、Apotex和Paddock也向FDA提交了Prolensa的仿制药上市申请。参考来源：The top 10 drugs losing US exclusivity in 2024. FiercePharma. 推荐阅读2023年专利即将到期的10款重磅药物Copyright © 2024 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。↑长按识别二维码 / 扫码即可报名↑