Johnson & Johnson Acquires Intra-Cellular Therapies, Strengthening Leadership in Neuroscience Field.

This acquisition includes CAPLYTA® (lumateperone), which is approved by the U.S. Food and Drug Administration (FDA).The First and Only Drug for Adjunctive Treatment and Monotherapy of Bipolar I and II Depression; meanwhile, the drug has also been approved for the treatment of adult schizophrenia.

--A supplemental New Drug Application (sNDA) for CAPLYTA as an adjunctive treatment for major depressive disorder has been submitted to the U.S. FDA; if approved, CAPLYTA is expected to become a standard treatment option for the most common form of depression.

--CAPLYTA joins Johnson & Johnson's robust lineup of therapeutic drugs,Its peak annual sales are expected to exceed $5 billion., and further solidified sales growth that exceeds analysts' expectations from now until the end of this decade.

-- A promising clinical-stage pipeline for generalized anxiety disorder as well as Alzheimer’s disease-related psychosis and agitation, with the potential to be the best in its class.

New Brunswick and Bedminster, New Jersey — (Business Wire) Johnson & Johnson (NYSE: JNJ) and Intra-Cellular Therapies (NASDAQ: ITCI) today announced that they have entered into a definitive agreement,Johnson & Johnson to Acquire All Outstanding Shares of Intra-Cellular Therapies for $132 Per Share in Cash.Intra-Cellular Therapies, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of treatments for central nervous system (CNS) disorders. The total equity value of this acquisition is approximately $14.6 billion.

Johnson & Johnson Chairman and CEO Joaquin Duato said, "Building on our nearly 70-year legacy in neuroscience, the acquisition of Intra-Cellular Therapies into our innovative pharmaceuticals business represents a unique opportunity that underscores our commitment to transforming care and advancing research in some of today’s most devastating neuropsychiatric and neurodegenerative diseases. This acquisition further differentiates our portfolio, acting as a catalyst for Johnson & Johnson’s short- and long-term strategic growth, delivering significant value to patients, healthcare systems, and shareholders."

According to the agreement, Johnson & Johnson will incorporate Intra-Cellular Therapies' CAPLYTA (CAPLYTA®, lumateperone), an oral therapy taken once daily, approved for the treatment of adult schizophrenia, as well as for use as a monotherapy or in combination with lithium or valproate as an adjunctive therapy.Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression)This acquisition also includes ITI-1284, a promising compound currently in Phase 2 research, being studied for generalized anxiety disorder (GAD) as well as psychosis and agitation related to Alzheimer’s disease. Additionally, it features a clinical-stage pipeline that further complements and strengthens Johnson & Johnson's current areas of focus.

Jennifer Taubert, Executive Vice President of Johnson & Johnson and Chairman of Global Innovative Pharmaceuticals, stated: "We are delighted to welcome the outstanding talent and world-class expertise of Intra-Cellular Therapies to Johnson & Johnson. By working together, we have the opportunity to impact more patients suffering from neuropsychiatric and neurodegenerative diseases, significantly advance healthcare, and help improve the lives of millions of people worldwide."

Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies, stated, "The success of CAPLYTA and the strong pipeline we have built are a testament to the passion and dedication of our outstanding team. We are proud to have helped hundreds of thousands of patients. Johnson & Johnson has long been committed to the field of neuroscience, and we believe that by working together, we can bring benefits to even more patients worldwide."

In December 2024, Intra-Cellular Therapies announced to the U.S. Food and Drug Administration (FDA)Submission of a Supplemental New Drug Application (sNDA) for CAPLYTA as an Adjunctive Treatment for Adults with Major Depressive Disorder (MDD).

In two global, double-blind, placebo-controlled Phase 3 studies, CAPLYTA, as an adjunctive treatment to antidepressants, demonstrated statistically and clinically significant improvements in depressive symptoms based on both clinician assessments and patient self-reported outcomes. The safety profile of CAPLYTA in these studies was consistent with existing clinical data, with no new safety concerns identified.

If approved, CAPLYTA could become the first drug in over 15 years to be approved for treating major depressive disorder and depressive symptoms associated with bipolar I and II disorders.Currently, more Phase 3 trials of CAPLYTA for bipolar I disorder (bipolar mania) with manic episodes or manic episodes with mixed features are ongoing.Positive Topline Results Announced in November 2024 for CAPLYTA in Preventing Relapse in Adults with Schizophrenia.

Although the exact mechanism of action of CAPLYTA is unclear, it is unique in that it has a high occupancy of serotonin 5-HT2A receptors and a low occupancy of dopamine D2 receptors at therapeutic doses. In short-term clinical trials for all three approved indications, CAPLYTA was similar to placebo in terms of weight change, metabolic effects, and extrapyramidal symptoms, which are often considered reasons for discontinuation.

The most common adverse reactions are somnolence/sedation, dizziness, nausea, and dry mouth. For all three approved indications, CAPLYTA can be taken at any time of the day, without regard to food intake, and does not require titration; adult patients can start treatment at an effective dose.

"CAPLYTA has demonstrated robust efficacy, proven safety, and good tolerability across all three approved indications, without the need for dose titration commonly required by such therapies. With positive Phase 3 data as an adjunctive treatment for major depressive disorder and additional Phase 3 trials ongoing for other mental health disorders, we believe CAPLYTA has the potential to become a new standard of care for treating some of the most prevalent and debilitating mental health disorders today," said Dr. John Reed, Executive Vice President of Johnson & Johnson and Head of Innovative Medicine.

As the mental health crisis intensifies and the global population ages, more than 1 billion people worldwide — 1 in every 8 individuals — are living with neuropsychiatric or neurodegenerative disorders. In the United States:

• Approximately 2.4 million adults suffer from schizophrenia,This is a serious chronic mental illness that causes distortions in thinking, perception, emotions, and behavior;

• Approximately 6.1 million adults suffer from bipolar disorder,This is a chronic, lifelong disease that causes drastic changes in a person’s mood, energy, and ability to think clearly, making it difficult for patients to carry out daily activities.

• It is estimated that 21 million adults suffer from major depressive disorder,This is one of the most common mental illnesses and a leading cause of disability;

• Approximately 6.8 million adults suffer from generalized anxiety disorder,It is a mental and behavioral disorder that causes excessive and uncontrollable worry and fear.

• Approximately 6 million adults suffer from Alzheimer's disease,This is a neurodegenerative brain disease that causes progressive memory loss and cognitive decline, severely impacting daily life.

Transaction Details and Completion Path

Under the terms of the agreement, Johnson & Johnson will acquire all outstanding shares of Intra-Cellular Therapies for $132 per share in cash. Johnson & Johnson expects to fund the transaction through a combination of cash on hand and debt. The company anticipates maintaining a strong balance sheet and continuing to support its established capital allocation priorities, which include investment in R&D, competitive dividends, value-creating acquisitions, and strategic share repurchases.

This transaction is expected to be completed later this year.Specifically, it depends on the approval of relevant regulatory authorities, the approval of Intra-Cellular Therapies shareholders, and other customary closing conditions for such transactions. After the completion of the transaction, the common stock of Intra-Cellular Therapies will no longer be listed for trading on the NASDAQ Global Select Market.

Johnson & Johnson will provide details on any potential impact of this transaction on adjusted earnings per share (EPS) when it releases preliminary full-year 2025 guidance during its fourth-quarter earnings call on Wednesday, January 22, 2025.

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