Darigabat

Download PDF Cerevel's clinical-stage assets complement AbbVie's emerging neuroscience pipeline and leading on-market brands in psychiatry, migraine and Parkinson's disease Emraclidine, a potential best-in-class, next-generation antipsychotic, is in trials designed to be registration enabling for schizophrenia Cerevel is a strong strategic fit for AbbVie and has potential to meaningfully impact revenue into the next decade AbbVie reaffirms previously issued 2024 full-year adjusted diluted EPS guidance range of $10.71-$10.91; reaffirms previously issued third-quarter adjusted diluted EPS guidance range of $2.92-$2.96 NORTH CHICAGO, Ill., Aug. 1, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has completed its acquisition of Cerevel Therapeutics (NASDAQ: CERE). With the completion of the acquisition, Cerevel is now part of AbbVie. "AbbVie's acquisition of Cerevel strengthens our foundation in neuroscience and positions us to deliver sustainable long-term performance into the next decade and beyond," said Robert A. Michael, chief executive officer, AbbVie. "Our new Cerevel colleagues share our commitment to deliver meaningful change for patients living with neurological and psychiatric conditions. We are excited to welcome the talented Cerevel team to AbbVie." There are multiple programs in Cerevel's pipeline across several neurological and psychiatric conditions such as schizophrenia, Parkinson's disease and mood disorders, where there continues to be significant unmet need for patients. Cerevel's pipeline is highly complementary to AbbVie's existing neuroscience portfolio and the completion of the acquisition is an important step forward to delivering new and better tolerated therapies. Emraclidine, a potential best-in-class, next-generation antipsychotic, is a positive allosteric modulator (PAM) of the muscarinic M4 receptor that is being studied for the treatment of schizophrenia – a disease that affects approximately 24 million people worldwide.1 In a Phase 1b study, emraclidine has shown promising efficacy and safety and is currently completing two Phase 2 trials that were designed to be registration enabling. Tavapadon, a first-in-class dopamine D1/D5 selective partial agonist for the management of Parkinson's disease, is currently in Phase 3 studies and has potential for both monotherapy and adjunctive treatment. Tavapadon's efficacy and safety-tolerability profile could enable its utility in early Parkinson's disease, becoming a near-term complementary asset to AbbVie's existing symptomatic therapies for advanced Parkinson's disease. Recently, tavapadon met the primary endpoint in a pivotal Phase 3 study and data from additional Phase 3 trials of tavapadon are expected later this year. CVL-354, currently in Phase 1, is a potential best-in-class kappa opioid receptor (KOR) antagonist that has the potential to provide significantly improved efficacy and tolerability compared to existing treatments for major depressive disorder (MDD). Darigabat, currently in Phase 2, is an alpha 2/3/5 selective GABAA receptor PAM for treatment-resistant epilepsy and panic disorder. For additional background on the acquisition, please read the announcement press release here and view AbbVie's investor presentation here. Financial Terms AbbVie has acquired all outstanding Cerevel common stock for $45.00 per share. It is expected that Cerevel's common stock will cease to trade on the NASDAQ stock exchange prior to market open on August 1, 2024. This acquisition is expected to be accretive to adjusted diluted earnings per share (EPS) beginning in 2030. Full-Year 2024 Outlook AbbVie is reaffirming its previously issued 2024 full-year adjusted diluted EPS guidance range of $10.71-$10.91. This guidance includes a $0.19 per share dilutive impact related to the completed Cerevel acquisition. AbbVie's 2024 adjusted diluted EPS guidance includes an unfavorable impact of $0.60 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter. The company's 2024 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2024, as both cannot be reliably forecasted. AbbVie is reaffirming its previously issued 2024 third-quarter adjusted diluted EPS guidance range of $2.92-$2.96. AbbVie's 2024 third-quarter adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred in the quarter, as both cannot be reliably forecasted. __________________ 1 World Health Organization: Schizophrenia Key Facts. Available at: https://www-who-int.libproxy1.nus.edu.sg/news-room/fact- sheets/detail/schizophrenia. January 10, 2022. About AbbVie in Neuroscience At AbbVie, our commitment to preserving personhood of people around the world living with neurological and psychiatric disorders is unwavering. With more than three decades of experience in neuroscience, we are providing meaningful treatment options today and advancing innovation for the future. AbbVie's Neuroscience portfolio consists of approved treatments in neurological conditions, including migraine, movement disorders and psychiatric disorders, along with a robust pipeline of transformative therapies. We have made a strong investment in research and are committed to building a deeper understanding of neurological and psychiatric disorders. Every challenge makes us more determined and drives us to discover and deliver advancements for those impacted by these conditions, their care partners and clinicians. For more information, visit www.abbvie.com. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. Forward-Looking Statements Some statements in this news release, including those relating to the acquisition of Cerevel by AbbVie, are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward- looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period, the risk that the businesses will not be integrated successfully, disruption from the transaction making it more difficult to maintain business and operational relationships, negative effects of the consummation of the acquisition on the market price of AbbVie's common stock and/or operating results, significant transaction costs, unknown liabilities, the risk of litigation and/or regulatory actions related to the acquisition or Cerevel's business, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. View original content:https://www.prnewswire.com/news-releases/abbvie-completes-acquisition-of-cerevel-therapeutics-302212336.html SOURCE AbbVie Media: Gabrielle Tarbert, (224) 244-0111, gabrielle.tarbert@abbvie.com; Investors: Liz Shea, (847) 935-2211, liz.shea@abbvie.com

CEO Richard Gonzalez was clear that AbbVie did its due diligence and he does not expect big problems from the U.S. Federal Trade Commission. AbbVie’s $8.7 billion acquisition of Cerevel will help fill in gaps in the Chicago pharma’s pipeline with new areas to explore in neuroscience, but will regulators play ball? CEO Richard Gonzalez was clear that AbbVie did its due diligence and he does not expect big problems from the U.S. Federal Trade Commission, even though both companies have a schizophrenia drug. “Obviously we looked very carefully at the FTC risk before we proceeded forward. I can tell you, this acquisition is not anti-competitive,” Gonzalez said in a Thursday investor call. He noted that psychiatry is a very “crowded and fragmented” market with “literally dozens” of available medicines. Most entrants only capture portions of the market, leaving plenty of room for new options. Gonzalez also said that there are no overlapping mechanisms between Cerevel’s pipeline and AbbVie. Cerevel’s emraclidine is a muscarinic M4 selective positive allosteric modulator currently in phase 2 testing. As for Vraylar, which AbbVie markets for schizophrenia, Gonzalez said the therapy has a pretty low share of that market with the bulk of sales coming from bipolar disorder. “We have a lot of confidence that we will be able to get this through the FTC,” Gonzelez said. Analysts seemed to agree with Gonzalez. Mizuho Securities flagged overlap in schizophrenia, Parkinson's disease and major depressive disorder as areas that the FTC could take a closer look at—specifically the former. Mizuho’s Graig Suvannavejh, Ph.D., similarly noted the fragmented market that already exists in schizophrenia, with more than 20 available treatments and many companies involved. So even if the FTC does zoom in on this area of the overlapping portfolios, “we don't see a particular reason to be concerned,” Suvannavejh wrote. William Blair analysts similarly pointed to schizophrenia and the deal’s focus, emraclidine, but suggested there are other areas that could draw some additional scrutiny including Parkinson’s, where AbbVie has Duopa/Duodopa approved and ABBV-951 in development. Cerevel has tavapadon in phase 3 in the indication. “Despite the overlap, we note that these assets are all exploring different mechanisms and different lines of use, and the CNS space offers multiple generic and brand therapies that lessen the risk of market concentration,” William Blair wrote in a Thursday morning note.   A well-behaving molecule Emraclidine emerged as the highlight of the deal on AbbVie’s investor call. Chief Operating Officer Robert Michael called the therapy a “multibillion-dollar peak-sales opportunity” with significant potential to contribute to AbbVie’s growth in the 2030s. The therapy is going up against Karuna Therapeutics’ KarXT in the muscarinic class. That therapy was recently accepted by the FDA for review. Michael said that Cerevel’s asset is differentiated as a positive allosteric modulator that targets the M4 subtype, compared to KarXT which activates M1 and M4. Emraclidine is also just one active ingredient, whereas KarXT is a combination of xanomeline and trospium. Cerevel’s option is dosed once daily and does not need titration. Ease of dosing is key with the schizophrenia population, Michael noted. “The molecule itself, it behaves quite well. It has a good half-life and has minimal food effect. It is once a day, and I think that's a critical differentiator, especially in schizophrenia,” said Roopal Thakker, M.D., chief medical officer. Finally, “contrary to what has been reported for the most advanced muscarinic receptor modulator,” emraclidine has also had low rates of gastrointestinal side effects such as nausea, vomiting, dyspepsia and constipation. AbbVie plans to quickly bulk up the emraclidine program once the deal closes. Michael detailed a plan to add additional studies to expand the use case in schizophrenia, particularly in international markets such as Europe and Japan. The company will also target an adjunctive indication to pair emraclidine with existing anti-psychotic drugs which could help address an unmet need in psychiatric care. The drug will also be developed in a long-acting injectable formulation, which could help with patient adherence, Michael said. Other potential indications for emraclidine include dementia-related psychosis in patients with Alzheimer's and Parkinson's diseases. Thakker expects an initial approval for emraclidine in 2026 with international regulatory clearance in the following years. “It is clear to us that the majority of the deal value is likely ascribed to emraclidine,” William Blair wrote. But Cerevel also brings tavapadon, a dopamine D1/D5 selective partial agonist for Parkinson’s, darigabat for treatment-resistant epilepsy and CVL-871 for dementia-related apathy.   Done deals This is AbbVie’s second acquisition in a week, following the $10.1 billion cash offer for ImmunoGen, the maker of antibody-drug conjugate ovarian cancer treatment Elahere. Gonzalez has made no secret of his desire for deals on recent earnings calls and suggested today that these two could quell his appetite for bigger outlays—for now. “We have previously said that our BD efforts were focused on identifying assets that can drive growth in the next decade and we've accomplished that by adding to our oncology and neuropsych pipeline through both the Immunogen and Cerevel deals,” Michael said. “I would not anticipate similar-sized transactions for the foreseeable future. That said, we will continue to pursue smaller size, early stage opportunities that can further support growth in the next decade.” And that’s not because AbbVie can’t do another big deal. Michael said the company has the balance sheet capacity. “It's because of the strength of our current on market and pipeline portfolio, plus five key growth areas which both Immunogen and Cerevel both very nicely complement,” he said. Mizuho expects the deal will go ahead as announced, with both boards already in support and few outside pharmas likely to make a better bid.