Core Insights - Viatris (VTRS) has acquired Tokyo-based Aculys Pharma, focusing on enhancing its Central Nervous System (CNS) portfolio and expanding its presence in Japan and the Asia-Pacific region [1][3][6] Acquisition Details - The acquisition involves an undisclosed upfront payment to Aculys Pharma's shareholders, with additional payments linked to regulatory and commercial milestones, as well as royalties based on net sales [2] - Viatris has secured exclusive rights to develop and commercialize pitolisant and Spydia (diazepam nasal spray) in Japan and select Asia-Pacific markets [1][6][7] Product Information - Pitolisant is a selective/inverse agonist of the histamine H3 receptor, with plans for marketing approval in Japan by the end of 2025 for treating excessive daytime sleepiness (EDS) and cataplexy in narcolepsy patients [4][9] - Spydia, approved in June 2025 in Japan, is the first intranasal anti-seizure medication for status epilepticus, addressing unmet needs in neurological emergencies [7][8] Strategic Rationale - The acquisition aims to leverage Viatris' commercial infrastructure and CNS expertise, aligning with its strategy to grow in high-impact therapeutic areas [9][10] - This move complements Viatris' existing innovative portfolio in Japan, which includes products for various conditions, thereby positioning the company for near- and mid-term growth [10]

Core Viewpoint - Idorsia Ltd has secured a CHF 150 million new money facility to extend its cash runway to mid-2026 and has provided an update on the restructuring of its convertible bond debt, along with an upgraded financial outlook for 2025 and beyond [2][3][9]. Financial Update - The new money facility will be drawn down in the coming days and has a maturity of 24 months, fully backed by a bondholder group [3]. - The company expects net sales of around CHF 130 million for QUVIVIQ in 2025, with a projected non-GAAP operating loss of approximately CHF 175 million [16][19]. - Idorsia aims to achieve sustainable commercial profitability in 2026 and overall profitability by the end of 2027, with QUVIVIQ sales ramping up to around CHF 210 million in 2026 and CHF 270 million in 2027 [19][20]. Commercial Strategy - The company is focusing on the commercial ramp-up of QUVIVIQ, which has seen a 50% growth quarter on quarter in Q1 2025, with 10 million tablets prescribed compared to 15 million for the entire year of 2024 [6][8]. - Efforts are being made to secure reimbursement in various countries, including Spain and the Nordic region, and to expand co-promotion partnerships in the GP market [6][9]. Debt Restructuring - Approximately 90% of bondholders have agreed to amend terms and exchange bonds for newly created notes in Idorsia Investments SARL, which will help remove the convertible debt overhang [9][12]. - The restructuring will sequester rights to three of Idorsia's assets, allowing for the repayment of the newly created notes [11][13]. R&D and Pipeline - Idorsia has a strong track record in discovering first- or best-in-class drugs and is prioritizing assets in its pipeline that have the greatest potential for mid-term value creation [10]. - The company is actively working on several compounds, including QUVIVIQ, lucerastat, and others, with ongoing clinical trials and regulatory discussions [25][36][29]. Future Outlook - The company expects to achieve positive operating cash flow from 2028 onwards and plans to raise CHF 50 million via a new equity line to extend its cash runway [21]. - Idorsia is also exploring options to finance operations and repay the new money facility at maturity [21].

Financial Performance Q1 2025 - Total Revenues were $3.3 billion, a decrease of 11% compared to Q1 2024[16, 74] - Adjusted EBITDA was $923 million, a decrease of 23% compared to Q1 2024[16, 74] - Adjusted EPS was $0.50, a decrease of 25% compared to Q1 2024[16, 74] - Free Cash Flow was $493 million, or $535 million excluding transaction costs[17] Impact of Indore Facility - The FDA issued a warning letter and import alert related to the oral finished dose manufacturing facility in Indore, India, leading to an estimated revenue impact of ~$140 million in Q1 2025[8, 94] - The estimated full-year 2025 revenue impact is ~$500 million, with an adjusted EBITDA impact of ~$385 million, including ~$100 million in penalties and supply disruptions[2, 94] - The estimated 2025 net sales impact by region is approximately $300 million in North America, $75 million in Europe, and $125 million in Emerging Markets[2] Financial Guidance 2025 - Total Revenues are projected to be between $13.5 billion and $14 billion[99] - Adjusted EBITDA is projected to be between $3.89 billion and $4.19 billion[99] - Adjusted EPS is projected to be between $2.16 and $2.30[99] - Free Cash Flow is projected to be between $1.8 billion and $2.2 billion[99] R&D Pipeline Update - Positive Phase 3 readouts were achieved for novel fast-acting meloxicam and XULANE LO[18] - A positive Phase 3 readout for EFFEXOR® for generalized anxiety disorder was achieved, and an sNDA was filed in Japan[18] - Selatogrel and cenerimod enrollment are on track[18] - The company is advancing 11 Phase 3 programs[22] Capital Allocation - The company returned >$450 million of capital to shareholders YTD, including >$300 million in share repurchases and ~$143 million in dividends paid[18, 111] - The company expects $500 million-$650 million in total share repurchases in 2025[2]

Core Insights - Nxera Pharma has made significant progress since its transformation from Sosei Heptares, aiming to lead biopharmaceutical innovation in Japan and globally [2][3] - The company anticipates 2025 to be a pivotal year with key data readouts from multiple clinical trials and new studies commencing [3] Operational Highlights - Neurocrine initiated a Phase 3 program for NBI-1117568 targeting schizophrenia, supported by positive Phase 2 data [5] - Nxera assigned rights for cenerimod to Viatris, receiving an upfront payment of US$10 million, with additional milestone and royalty potential [6] - An agreement was signed with Holling Bio-Pharma for the commercialization of daridorexant in Taiwan, with a potential launch in 2026 [6] - Clinical development plans for partnered muscarinic agonists include multiple Phase 2 and Phase 3 studies scheduled for 2025 [6] Financial Highlights - Revenue for Q1 2025 totaled JPY 6,644 million (US$43.5 million), an increase of JPY 2,033 million (US$12.5 million) year-over-year, primarily due to the launch of QUVIVIQ® and an R&D milestone event [11] - R&D expenses rose to JPY 3,808 million (US$25.0 million), reflecting increased investment and the impact of a weaker Yen [11] - Operating loss improved to JPY 2,193 million (US$14.4 million) from JPY 3,076 million (US$20.7 million) in the prior year [11] - Net loss decreased to JPY 760 million (US$5.0 million) from JPY 3,281 million (US$22.1 million) in the previous year [11] - Cash and cash equivalents as of 31 March 2025 were JPY 34,465 million (US$230.0 million), an increase of JPY 2,197 million (US$24.3 million) since the beginning of the year [11] Corporate Developments - New appointments to the Board of Directors include Ms. Naoko Shimura and Ms. Nicola Rabson as External Directors [6] - Mr. Kiyoshi Kaneko was appointed Chief Commercial Officer, and Ms. Mariko Nakafuji was promoted to Chief Legal Officer [11] Pipeline and Strategy - Nxera is advancing over 30 active programs from discovery to late clinical stages, focusing on neurology, metabolic diseases, and immunology [10][12] - The company aims to address major unmet needs in rapidly growing medical areas, leveraging its NxWave™ discovery platform [10][12]