In October 2023, William Blair wrote that in fiscal year 2024, Catalent anticipates 30% Y/Y growth in nonCOVID biologics revenue, reaching approximately $1.35 billion to $1.80 billion. This growth is primarily fueled by a 60%-plus expansion attributed to Sarepta, translating into an estimated total revenue of nearly $700 million from the collaboration. Despite this, questions remain about Catalent's manufacturing capacity and the future role of Thermo Fisher Scientific Inc TMO as a secondary manufacturer. W ...

It has been about a month since the last earnings report for Catalent (CTLT) . Shares have added about 0.4% in that time frame, underperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Catalent due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts. Catalent Q3 Earnings Lag Estimates, Gross Margin ...

Leadership Transition - Harry Christiaens, PhD, retires as CEO after 20 years of leadership, remaining on the Board [1] - Jeremie Trochu appointed as new CEO, bringing 20 years of experience in the biopharma and CDMO industry [1][2] - Jeremie Trochu has a proven track record in global business growth, market expansion, and large-scale transformations, with deep transatlantic experience in European and North American markets [2] Company Growth and Vision - Ardena has grown from a local 10-person consultancy to a world-leading CDMO with over 500 employees and five facilities across Europe under Harry Christiaens' leadership [3] - The company recently invested EUR 25 million in state-of-the-art GMP nanomedicine and aseptic fill-finish capabilities [3] - Jeremie Trochu's global mindset and US market experience align with Ardena's ambitions for international expansion [3] Industry Expertise and Services - Ardena is a leading CDMO specializing in advanced drug development for innovative and complex molecules, aiming to accelerate therapies to the clinic and patients [4] - The company provides integrated services including solid-state chemistry, API and nanomedicine development, analytical and formulation development, drug product manufacturing, and regulatory services [5] - Ardena serves a wide range of clients, from emerging biotechs to big pharma, supporting drug discovery and development processes [5]

Company Overview - Catalent, Inc. has entered a strategic partnership with Siren Biotechnology to support the development and manufacturing of adeno-associated viral (AAV) immuno-gene therapies, which is expected to enhance its Biologics business and strengthen its position in this niche market [1][5]. Collaboration Details - Under the partnership, Catalent will provide process development and cGMP manufacturing for Siren Biotechnology's AAV vector-based therapeutic candidates intended for clinical trials, along with process optimization support at its Baltimore, MD facility [2]. - The collaboration aims to facilitate the development and commercial manufacturing of safe and high-quality AAV gene therapies, potentially offering life-saving treatments for cancer patients [3]. Industry Prospects - The global adeno-associated virus vector manufacturing market was valued at $767.7 million in 2022 and is projected to grow at a CAGR of 22.5% from 2023 to 2030, driven by an increase in clinical trials and advancements in gene therapies [4]. Financial Performance - Catalent reported a year-over-year improvement in its overall top-line and bottom-line results for the third quarter of fiscal 2024, with continued momentum in the Biologics segment contributing to increased consolidated sequential revenues and adjusted EBITDA margin for the second consecutive quarter [6]. Stock Performance - Catalent's shares have increased by 68.2% over the past year, significantly outperforming the industry, which saw a decline of 10.1%, while the S&P 500 index grew by 26.5% during the same period [7].

Catalent, Inc. (CTLT) reported third-quarter fiscal 2024 adjusted loss per share of 6 cents, which was narrower than the year-ago period’s loss per share of 9 cents. The Zacks Consensus Estimate was pegged at an earnings per share (EPS) of 24 cents.The adjustments include charges related to amortization, and impairment charges and gain/loss on the sale of assets, among others.The company’s GAAP loss per share was 56 cents during the quarter, narrower than the year-ago period’s loss per share of $1.26.Revenu ...

Catalent (CTLT) came out with a quarterly loss of $0.06 per share versus the Zacks Consensus Estimate of $0.24. This compares to loss of $0.09 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -125%. A quarter ago, it was expected that this maker of drug delivery technologies would post a loss of $0.03 per share when it actually produced a loss of $0.24, delivering a surprise of -700%.Over the last four quarters, the company has ...

Part I. Financial Information This section presents the company's financial statements, management's discussion, market risk disclosures, and internal controls [Financial Statements (unaudited)](index=9&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) For the nine months ended March 31, 2024, Catalent reported a net loss of $1.066 billion, a significant increase from a $146 million loss in the prior-year period, primarily driven by a $687 million goodwill impairment charge. Total assets decreased to $9.88 billion from $10.78 billion, mainly due to the goodwill impairment. Cash from operating activities was $54 million, a slight decrease from the prior year Consolidated Statements of Operations Highlights | | Three Months Ended March 31, | Nine Months Ended March 31, | | :--- | :--- | :--- | :--- | :--- | | (In millions) | **2024** | **2023** | **2024** | **2023** | | **Net revenue** | $1,074 | $1,037 | $3,080 | $3,208 | | **Gross margin** | $229 | $180 | $569 | $825 | | **Goodwill impairment charges** | $0 | $210 | $687 | $210 | | **Operating loss** | $(17) | $(235) | $(855) | $(37) | | **Net loss** | $(101) | $(227) | $(1,066) | $(146) | | **Net loss per share (Basic & Diluted)** | $(0.56) | $(1.26) | $(5.87) | $(0.81) | Consolidated Balance Sheets Highlights | | March 31, 2024 | June 30, 2023 | | :--- | :--- | :--- | | (In millions) | | | | **Cash and cash equivalents** | $162 | $280 | | **Goodwill** | $2,339 | $3,039 | | **Total assets** | $9,879 | $10,777 | | **Total liabilities** | $6,268 | $6,166 | | **Total shareholders' equity** | $3,611 | $4,611 | Consolidated Statements of Cash Flows Highlights | | Nine Months Ended March 31, | | :--- | :--- | :--- | | (In millions) | **2024** | **2023** | | **Net cash provided by operating activities** | $54 | $58 | | **Net cash used in investing activities** | $(253) | $(834) | | **Net cash provided by financing activities** | $84 | $572 | | **Net decrease in cash and cash equivalents** | $(118) | $(197) | [Notes to Unaudited Consolidated Financial Statements](index=18&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) The notes detail significant accounting policies, revenue recognition, business combinations, and major financial events. Key disclosures include a $687 million goodwill impairment charge, restructuring activities including a facility closure, and the pending merger agreement with Novo Holdings for $16.5 billion. The company also details its debt structure, including new term loans, and identifies major customers, with one customer representing 31% of net trade receivables - The company operates through two reportable segments: Biologics and Pharma and Consumer Health[43](index=43&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk) - A goodwill impairment charge of **$687 million** was recorded for the nine months ended March 31, 2024, related to the Consumer Health and Biomodalities reporting units due to underperformance and macroeconomic conditions[77](index=77&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) - On February 5, 2024, Catalent entered into a merger agreement with Novo Holdings to be acquired for **$63.50 per share** in cash, valuing the company at an enterprise value of **$16.5 billion**. The deal is subject to stockholder and regulatory approval[137](index=137&type=chunk)[138](index=138&type=chunk)[139](index=139&type=chunk) - One customer in the Biologics segment represented **31% of net trade receivables** as of March 31, 2024, and **14% of consolidated net revenue** for the third quarter[50](index=50&type=chunk) - In December 2023, the company incurred **$600 million** in new Term B-4 Loans to repay its existing Revolving Credit Facility[86](index=86&type=chunk) - The company is undergoing restructuring plans to reduce costs and optimize infrastructure, which includes closing its San Francisco facility. Restructuring costs for the nine months ended March 31, 2024, were **$30 million**[95](index=95&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=44&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion focuses on financial performance, segment results, and liquidity. For the nine months ended March 31, 2024, net revenue decreased 4% to $3.08 billion, primarily due to a significant decline in COVID-19 related programs. This led to a substantial net loss of $1.066 billion, exacerbated by a $687 million goodwill impairment. The Biologics segment saw a 15% revenue decline, while the Pharma and Consumer Health segment grew 6%. The company believes its liquidity, including $1.10 billion available under its revolving credit facility, is sufficient for the next 12 months [Q3 FY2024 vs. Q3 FY2023 Results](index=47&type=section&id=Three%20Months%20Ended%20March%2031%2C%202024%20Compared%20to%20the%20Three%20Months%20Ended%20March%2031%2C%202023) In Q3 FY2024, net revenue increased 4% to $1.074 billion (3% in constant currency), driven by growth in prescription products, gene therapy, and consumer health, which was partially offset by declining COVID-19 program demand. Gross margin improved to 21.3% from 17.4% in the prior year. The company reported a net loss of $101 million, a significant improvement from the $227 million loss in Q3 2023, which had included a $210 million goodwill impairment charge Q3 FY2024 vs. Q3 FY2023 Performance Summary | (Dollars in millions) | Q3 2024 | Q3 2023 | Change % (Constant Currency) | | :--- | :--- | :--- | :--- | | **Net revenue** | $1,074 | $1,037 | 3% | | **Gross margin** | $229 | $180 | 26% | | **Operating loss** | $(17) | $(235) | 91% | | **Net loss** | $(101) | $(227) | 55% | - Organic revenue grew **3%**, driven by prescription products, Zydis commercial products, and consumer health products, partially offset by a decline in COVID-19 related programs[170](index=170&type=chunk) Q3 FY2024 Segment Performance (Constant Currency) | Segment | Net Revenue Change % | Segment EBITDA Change % | | :--- | :--- | :--- | | **Biologics** | (3)% | 876% | | **Pharma and Consumer Health** | 8% | 21% | [Nine Months FY2024 vs. FY2023 Results](index=53&type=section&id=Nine%20Months%20Ended%20March%2031%2C%202024%20Compared%20to%20the%20Nine%20Months%20Ended%20March%2031%2C%202023) For the first nine months of FY2024, net revenue decreased 4% to $3.08 billion (-5% in constant currency), primarily due to a significant decline in demand for COVID-19 related programs. Gross margin fell to 18.5% from 25.7%. The company recorded a net loss of $1.066 billion, compared to a $146 million loss in the prior-year period, largely driven by a $687 million goodwill impairment charge. The Biologics segment revenue declined 15%, while the Pharma and Consumer Health segment grew 5% (3% organic) Nine Months FY2024 vs. FY2023 Performance Summary | (Dollars in millions) | 9M 2024 | 9M 2023 | Change % (Constant Currency) | | :--- | :--- | :--- | :--- | | **Net revenue** | $3,080 | $3,208 | (5)% | | **Gross margin** | $569 | $825 | (32)% | | **Goodwill impairment charges** | $687 | $210 | * | | **Operating loss** | $(855) | $(37) | * | | **Net loss** | $(1,066) | $(146) | * | - Organic revenue decreased **6%** on a constant-currency basis, primarily due to a significant decline in demand for COVID-19 related programs[188](index=188&type=chunk) - A goodwill impairment charge of **$687 million** was recorded, associated with the Consumer Health and Biomodalities reporting units[192](index=192&type=chunk) Nine Months FY2024 Segment Performance (Constant Currency) | Segment | Net Revenue Change % | Segment EBITDA Change % | | :--- | :--- | :--- | | **Biologics** | (15)% | (55)% | | **Pharma and Consumer Health** | 5% | 1% | [Liquidity and Capital Resources](index=59&type=section&id=Liquidity%20and%20Capital%20Resources) The company's principal sources of liquidity are cash from operations and capital markets. As of March 31, 2024, Catalent had $1.10 billion available under its revolving credit facility. Management believes cash on hand and available borrowings are adequate to meet liquidity needs for the next 12 months. For the nine months ended March 31, 2024, cash from operations was $54 million, cash used in investing was $253 million (down from $834 million due to less M&A), and cash from financing was $84 million - As of March 31, 2024, the company had **$1.10 billion** in borrowing capacity available under its revolving credit facility[210](index=210&type=chunk) Cash Flow Summary (Nine Months Ended March 31) | (Dollars in millions) | 2024 | 2023 | $ Change | | :--- | :--- | :--- | :--- | | **Operating activities** | $54 | $58 | $(4) | | **Investing activities** | $(253) | $(834) | $581 | | **Financing activities** | $84 | $572 | $(488) | - The company was in compliance with all material debt covenants under its Credit Agreement and Senior Notes Indentures as of March 31, 2024[218](index=218&type=chunk)[222](index=222&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=62&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that there have been no material changes in its quantitative and qualitative disclosures about market risks from those disclosed in its Annual Report on Form 10-K for the fiscal year ended June 30, 2023 - As of March 31, 2024, there has been no material change in the company's market risk information from the Fiscal 2023 10-K[232](index=232&type=chunk) [Controls and Procedures](index=63&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that as of March 31, 2024, the company's disclosure controls and procedures were not effective at a reasonable assurance level. This conclusion is based on the identification of five distinct, unremediated material weaknesses in internal control over financial reporting related to contract modifications, income tax provisions, revenue recognition, the financial statement close process, and inventory reconciliation. The company has outlined remediation plans for each weakness, which are currently in progress - The CEO and CFO concluded that as of March 31, 2024, disclosure controls and procedures were not effective due to material weaknesses in internal control over financial reporting[234](index=234&type=chunk) - The company identified five material weaknesses that remain unremediated as of March 31, 2024: - **Contract Modifications:** Ineffective controls to properly identify and assess accounting for contract modifications under ASC 606 - **Income Tax Provision:** Ineffective controls over the preparation and review of the interim income tax provision - **Revenue Recognition:** Ineffective controls over revenue recognition for customer agreement modifications at the Bloomington, Indiana facility - **Financial Statement Close Process:** Ineffective controls over evaluating and accounting for complex non-routine transactions, such as goodwill impairment assessments - **Inventory Reconciliation:** Ineffective controls over inventory reconciliation at the Baltimore, Maryland facility[236](index=236&type=chunk)[237](index=237&type=chunk)[239](index=239&type=chunk)[242](index=242&type=chunk)[244](index=244&type=chunk) - Management has developed and is implementing remediation plans for each material weakness, with an expected completion by the fourth quarter of fiscal 2024[245](index=245&type=chunk)[246](index=246&type=chunk)[249](index=249&type=chunk)[250](index=250&type=chunk)[251](index=251&type=chunk) Part II. Other Information This section covers legal proceedings, risk factors, equity sales, and other disclosures [Legal Proceedings](index=67&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in a shareholder class-action lawsuit (City of Warwick Retirement System v. Catalent, Inc., et al.) alleging violations of securities laws, including overstated revenue and material weaknesses in internal controls. The company filed a motion to dismiss the complaint in November 2023 and is awaiting the court's decision. Related derivative claims have been voluntarily dismissed - The company is defending against a shareholder class-action lawsuit alleging accounting schemes and failure to disclose adverse facts between August 2021 and May 2023. A motion to dismiss is pending[130](index=130&type=chunk) - Two related shareholder derivative lawsuits (Husty and Brown) were voluntarily dismissed by the plaintiffs in April and May 2024[131](index=131&type=chunk)[132](index=132&type=chunk) [Risk Factors](index=67&type=section&id=Item%201A.%20Risk%20Factors) The primary risk factors highlighted relate to the pending merger with Novo Holdings. These include the risk that the merger may not be completed on time or at all, potential adverse effects on the business during the pendency of the deal, the requirement to pay a substantial termination fee of approximately $345 million under certain circumstances, and restrictions on business activities while the agreement is in effect. Other risks include potential litigation related to the merger - There is a risk that the pending merger with Novo Holdings may not be completed within the anticipated timeframe, or at all, due to failure to meet closing conditions like stockholder and regulatory approvals[257](index=257&type=chunk)[258](index=258&type=chunk) - The company could be required to pay Novo Holdings a termination fee of approximately **$345 million** if the Merger Agreement is terminated under specific circumstances[259](index=259&type=chunk)[263](index=263&type=chunk) - The announcement and pendency of the merger could disrupt business, affect employee retention, and negatively impact relationships with customers and suppliers[261](index=261&type=chunk) - While the Merger Agreement is in effect, the company is subject to restrictions on its business activities, including limitations on acquisitions, asset sales, investments, and incurring debt[266](index=266&type=chunk)[267](index=267&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=69&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the quarter ended March 31, 2024, the company did not sell any unregistered equity securities and did not purchase any of its own equity securities - No unregistered equity securities were sold during the period[274](index=274&type=chunk) - The company did not purchase any of its equity securities during the period[275](index=275&type=chunk) [Defaults Upon Senior Securities](index=70&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None reported - None[276](index=276&type=chunk) [Mine Safety Disclosures](index=70&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - Not applicable[277](index=277&type=chunk) [Other Information](index=70&type=section&id=Item%205.%20Other%20Information) During the fiscal quarter ended March 31, 2024, none of the company's directors or officers adopted or terminated any trading plans for the purchase or sale of company securities - No directors or officers adopted or terminated Rule 10b5-1 trading plans during the quarter[278](index=278&type=chunk)

• 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. (1) • Q3'24 Adjusted EBITDA of $163 million increased 55% as reported, or 53% in constant currency, compared to Q3'23. "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, w ...

Investors with an interest in Medical - Drugs stocks have likely encountered both Takeda Pharmaceutical Co. (TAK) and Catalent (CTLT) . But which of these two stocks presents investors with the better value opportunity right now? Let's take a closer look.The best way to find great value stocks is to pair a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system. The Zacks Rank favors stocks with strong earnings estimate revision trends, and our Style Scores highlight comp ...

SAN DIEGO, April 10, 2024 (GLOBE NEWSWIRE) -- Shareholder rights law firm Robbins LLP informs investors it is investigating the acquisition of Catalent, Inc. (NYSE:CTLT) by Novo Holdings, a holding and investment company that is responsible for managing the assets and wealth of the Novo Nordisk Foundation. Under the terms of the agreement, Catalent stockholders will receive $63.50 in cash for each share of Catalent common stock owned. If you own shares of Catalent, Inc. click here. Is the Proposed Acquisiti ...