Nimbus Apollo, Inc.

The increasing number of clinical trials and subsequent approvals are expected to drive substantial market growth. Projections indicate that the IgAN treatment market by registering a CAGR of 6.2% in the forecast period 2025 to 2035 in the United States NEWARK, DE / ACCESSWIRE / January 13, 2025 / The IgA Nephropathy Market is poised for significant growth over the forecast period from 2025 to 2035, driven by advancements in diagnostics, therapeutic innovations, and an increasing prevalence of chronic kidney disease (CKD). In 2025, the market is valued at USD 46,821.70 million, with projections estimating a substantial increase to USD 99,655.4 million by 2035, reflecting a robust CAGR of 7.6%.Key factors fueling this growth include the rising adoption of biologics and biosimilar, an uptick in government funding for research and treatment programs, and improved accessibility to healthcare in emerging markets. The growing awareness among healthcare professionals and patients about IgA nephropathy, also known as Berger\'s disease, further strengthens market momentum.The emergence of targeted therapies, such as corticosteroids, immunosuppressant, and advanced monoclonal antibodies, has revolutionized treatment regimens. These therapies effectively manage proteinuria and inflammation, improving patient outcomes. Meanwhile, innovations in molecular diagnostics ensure early and precise disease detection, playing a pivotal role in reducing disease progression.North America currently dominates the market, owing to strong healthcare infrastructure, high awareness levels, and the availability of advanced treatment options. However, Asia-Pacific is anticipated to exhibit the fastest growth rate due to increasing patient populations and government investments in healthcare infrastructure.IgAN is an autoimmune disease that attacks the kidneys. It affects blood filtration in the small blood vessels of the kidneys. It occurs when an abnormal protein damages the filtering unit (glomerulus) inside the kidneys. This, in turn, causes pain leading to patients undertaking different forms of treatments. Which are Some Prominent Drivers of IgA Nephropathy Market?Conventional treatments and approval of medication favoring the growth of the marketConventional major treatments to manage IgAN include ACE inhibitors (angiotensin-converting enzyme inhibitors) and ARBs (angiotensin II receptor blockers), to manage symptoms like high blood pressure, etc. Other treatments include corticosteroids, to slow the progression of the disease, and other immunosuppressants like MMF, cyclophosphamide, etc.TARPEYO (budesonide) delayed-release capsules are the first and only FDA-approved drug for the treatment of IgAN. It is indicated for IgAN patients, who are at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. It was approved by the US FDA in December 2021, under an accelerated approval pathway, recognizing the urgent need for safe and efficacious therapies.The availability of therapeutic treatments creates lucrative opportunities for the IgA nephropathy marketTarpeyo: Calliditas Therapeutics ABTarpeyo (developed under the project name Nefecon) is a patented oral formulation of a potent and well-known active substance- budesonide for targeted release. The formulation is designed to deliver the drug to the Peyer\'s patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models. Tarpeyo is derived from the TARGIT technology, which allows the substance to pass through the stomach and intestine without being absorbed and released in a pulse-like fashion only when it reaches the lower small intestine.In addition to its potent local effect, another advantage of using this active substance is its very low bioavailability, i.e., around 90% of it is inactivated in the liver before it reaches systemic circulation. This means that a high concentration can be applied locally where needed but with only very limited systemic exposure and side effects.Sparsentan: Travere Therapeutics, IncSpartan is a first-in-class, orally active, single-molecule that functions as a high-affinity dual-acting antagonist of both endothelin type A (ETA) and angiotensin II subtype 1 (AT1) receptors which are associated with kidney disease progression.Endothelin I and angiotensin II lead to a decline in kidney function by contributing to inflammation and fibrosis in the kidney, changes to the shape of podocytes, podocyte loss, and increased permeability of the glomerular filtration barrier. Endothelin I and angiotensin II are also vasoconstrictive, meaning they cause a narrowing of blood vessels and an increase in pressure in the glomeruli.Reimbursement of treatments propelling the growth of the IgA nephropathy marketProactively approaching reimbursement can induce a positive impact both during the early stages of product development and well after product launch. The report considers reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select markets with better market access can be a critical business and price strategy.To assist patients and their healthcare providers who prescribe Tarpeyo, Calliditas has launched a comprehensive patient support program - Tarpeyo Touchpoints. It is a full-service patient and provider support program designed to accelerate and streamline access to Tarpeyo. It utilizes biologics by McKesson\'s Pharmacy Elite model integrated hub and exclusive specialty pharmacy under one roof and is staffed by care navigators and a designated rare pod team (nurses, pharmacists, fulfillment, and distribution team).Key Takeaways from Market StudyThe global IgA Nephropathy Market size will grow from USD 46,821.70 million in 2025 to USD 99,655.4 million by 2035, with a CAGR of 7.6%.Biologics and biosimilars are projected to dominate the therapeutic segment, offering enhanced efficacy and fewer side effects.North America leads the market, accounting for over 40% of revenue share in 2025. Asia-Pacific is expected to witness the fastest CAGR during 2025-2035.Increased healthcare expenditure and favorable government initiatives are boosting market dynamics globally.Innovative technologies in diagnostics and the adoption of digital health platforms will further drive market growth.\"The IgA Nephropathy Market is entering an era of transformative growth fueled by advancements in targeted therapies and precision medicine. Stakeholders focusing on R&D collaborations, digital health integration, and market expansion in developing economies will be well-positioned to capitalize on this growth trajectory. The integration of AI in diagnostics and a surge in biosimilar approvals further underscore the market\'s evolution,\" Says Sabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.)A Detailed Full Report - https://www.futuremarketinsights.com/reports/iga-nephropathy-marketCountry-wise Insights:The section below discusses the industry analysis for the IgA nephropathy market in several nations. Market demand analysis for important nations in numerous areas of the world, including North America, Latin America, East Asia, South Asia & Pacific, Western Europe, Eastern Europe, and Middle East & Africa, is provided.The United States is expected to remain the leader in North America, with a larger market share through 2035. In South Asia and the Pacific, India is expected to grow at a CAGR of 9.1% by 2035.CountriesValue CAGR (2025 to 2035)United States6.2%Germany4.4%China9.0%France2.4%India9.1%Spain5.7%Australia & New Zealand6.5%South Korea6.0%IgA Nephropathy Market Day-by-Day Opportunities:The IgA Nephropathy Market offers opportunities for stakeholders across the value chain, including pharmaceutical companies, diagnostic service providers, and healthcare technology firms. Key opportunities include:R&D in Precision Medicine: Investments in personalized medicine to create patient-specific therapies will likely transform disease management strategies.Expanding Biosimilars Market: Development and commercialization of cost-effective biosimilars will ensure accessibility in cost-sensitive regions.Technological Advancements in Diagnostics: AI-powered diagnostic tools and molecular biomarker research present avenues for early diagnosis.Strategic Collaborations: Partnerships between biotech companies and research institutions are expected to accelerate drug discovery processes.Component Insights:Therapeutics: Biologics are expected to dominate, accounting for more than 50% of market revenue by 2035. Monoclonal antibodies such as belimumab and rituximab show promise in reducing renal inflammation and improving patient prognosis.Diagnostics: Molecular diagnostics are anticipated to grow at a CAGR exceeding 8%, driven by the demand for early and accurate detection of IgA nephropathy.Services: Increased focus on patient-centered care has led to growth in home-based care services and telemedicine adoption.How do biomarkers contribute to the early diagnosis of IgA nephropathy?Biomarkers play a crucial role in the early diagnosis of IgA nephropathy (IgAN), also known as Berger\'s disease, by providing non-invasive and specific indicators of the disease\'s presence and progression. Here are the main ways in which biomarkers contribute to the early diagnosis of IgA nephropathy:Identification of Disease-Specific Biomarkers:Galactose-Deficient IgA1 (Gd-IgA1): Elevated levels of Gd-IgA1 in serum and urine have been identified as significant biomarkers for IgAN. Studies have shown that Gd-IgA1 levels correlate with disease activity, making it a potential marker for early diagnosis and monitoring of the diseaseImmune Complexes: The presence of Gd-IgA1-containing immune complexes is associated with the pathogenesis of IgAN. Measuring these complexes can help in identifying patients at risk for developing the diseaseCorrelation with Disease Activity:Biomarkers such as serum Gd-IgA1 and Gd-IgA1-specific antibodies have been linked to disease activity. Their levels can indicate inflammation and damage within the kidneys, allowing for earlier intervention before significant renal impairment occursNon-Invasive Testing:The use of serum and urinary biomarkers allows for non-invasive testing methods compared to traditional kidney biopsies, which are invasive and carry risks. This non-invasive approach can facilitate earlier diagnosis and monitoring without subjecting patients to unnecessary proceduresDifferentiation from Other Kidney Diseases:Certain biomarkers help differentiate IgAN from other renal diseases. For instance, assessing serum IgA levels and the serum IgA/C3 ratio can aid in distinguishing IgAN from conditions that present similarly, such as minimal change disease or focal segmental glomerulosclerosisMonitoring Progression and Treatment Response:Biomarkers not only assist in diagnosis but also in monitoring disease progression and response to treatment. For example, changes in urinary protein excretion can indicate worsening kidney function or effectiveness of therapeutic interventionsPredictive Models:Recent advancements include the use of machine learning models that incorporate various biomarkers to predict the likelihood of IgAN development or progression. These models analyze multiple factors, including age, serum albumin levels, and urinary findings, providing a comprehensive assessment that enhances diagnostic accuracyRegional Analysis of IgA Nephropathy Market:North America:Leading region with over 40% of revenue share in 2025.Strong focus on R&D and patient access to advanced therapies.Europe:Second-largest market, driven by government funding and adoption of biosimilars.Key focus on collaborative research initiatives.Asia-Pacific:Fastest-growing region, with a CAGR of over 8%.Increasing awareness, expanding healthcare infrastructure, and government support.Latin America & Middle East:Emerging markets with growing adoption of biologics and molecular diagnostics.Competitive Landscape:Key players in the IgA Nephropathy Market are employing a variety of strategies to maintain their competitive edge. Among these, product innovation remains a top priority, with companies focusing on developing unique formulations and advanced treatment options. To ensure effective market penetration, firms are forging strategic alliances with healthcare providers, aiming to streamline distribution networks and enhance accessibility to their products.Additionally, many organizations are actively pursuing partnerships and collaborations to diversify their product portfolios and strengthen their foothold in the global market. These partnerships not only accelerate R&D activities but also open avenues for expansion into emerging markets, boosting their overall market presence.Recent Industry Developments in IgA Nephropathy Market:March 9, 2023: Sandoz announced plans to establish a state-of-the-art biologics manufacturing facility in Lendava, Slovenia, by signing a memorandum of understanding (MOU).February 9, 2023: Takeda completed its acquisition of Nimbus Lakshmi, Inc., a subsidiary of Nimbus Therapeutics, thereby enhancing its pipeline of innovative therapeutics.January 11, 2023: Sanofi Ventures increased its capital commitment to over USD 750 million for its Evergreen Venture Fund, with a focus on scaling its investment capabilities and expanding its global influence.Key Players of IgA Nephropathy Market:Novartis AGSanofi S.A.AstraZenecaTakeda Pharmaceutical Company LimitedPfizer Inc.Validus Pharmaceuticals LLCOrganon Group of CompaniesKey Segments of IgA Nephropathy Market:By Diagnosis & Treatment:In terms of diagnosis & treatment, the industry is divided into- diagnosis and treatment.By Disease Type:In terms of disease type, the industry is segregated into- primary IgA nephropathy and secondary IgA nephropathy.By Indication:In terms of indication, the industry is segregated into- hematuria, proteinuria, hypertension, edema and others.By Population Type:In terms of population type, the industry is segregated into- pediatrics and adults.By Route of Administration:In terms of route of administration, the industry is segregated into- oral and parenteral.By End User:In terms of end user, the industry is segregated into- hospitals, specialty clinics, homecare and others.By Region:Key countries of North America, Latin America, Western Europe, Eastern Europe, South Asia and Pacific, East Asia and Middle East and Africa (MEA) have been covered in the report.AuthorSabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.) holds over 12 years of experience in the Healthcare, Medical Devices, and Pharmaceutical industries. His curious and analytical nature helped him shape his career as a researcher.Identifying key challenges faced by clients and devising robust, hypothesis-based solutions to empower them with strategic decision-making capabilities come naturally to him. His primary expertise lies in areas such as Market Entry and Expansion Strategy, Feasibility Studies, Competitive Intelligence, and Strategic Transformation.Holding a degree in Microbiology, Sabyasachi has authored numerous publications and has been cited in journals, including The Journal of mHealth, ITN Online, and Spinal Surgery News.Explore FMI\'s Extensive Coverage in the Healthcare Domain:The global sales of surgical navigation system is estimated to be worth USD 1,235.7 million in 2025 and anticipated to reach a value of USD 2,255.2 million by 2035.The aortic stents grafts market size is anticipated to be worth USD 2.5 billion in 2023. The market is assumed to surge at a CAGR of 5% during the forecast period and, reach USD 4.2 billion by 2033.The coronary artery bypass graft market is estimated to be valued at USD 17,612.1 million in 2023. The coronary artery bypass graft industry is likely to cross a valuation of USD 22,765.9 million by 2033.In 2023, the adoption of coronary stent in India stands at a valuation of USD 843.8 million. This surge is attributed to the demand for minimally invasive procedures to address the rising cases of cardiovascular diseases.The coronary intravascular lithotripsy market size is projected to be worth USD 324.4 Million in 2023. The market is likely to surpass USD 592.2 Million by 2033 at a CAGR of 6.2% during the forecast periodThe visual electrophysiology market is anticipated to flourish at a steady CAGR of 7.0% between 2023 and 2033.The immunochemistry analyzer market is expected to register a CAGR of 16% during the forecast period, up from USD 14.2 Billion in 2021, to reach a valuation of USD 72.69 Billion by 2032.The immunochemistry products market is anticipated to record a CAGR of 7.25% during the forecast period, up from USD 2.08 Billion in 2021 to reach a valuation of USD 4.5 Billion by 2032.The global birch allergy treatment market garnered a market value of USD 571 Million in 2023 and is expected to accumulate a market value of USD 1123.24 Million by registering a CAGR of 7%The global nasal allergy treatment market enjoys a valuation of USD 6.6 Billion in 2022, and it is further projected to expand at a CAGR of 6.7%About Future Market Insights (FMI)Future Market Insights (FMI) is a leading provider of market intelligence and consulting services, serving clients in over 150 countries. FMI is headquartered in Dubai and has delivery centres in the United Kingdom, the United States, and India. FMI\'s latest market research reports and industry analysis helps businesses navigate challenges and make critical decisions with confidence and clarity amidst breakneck competition. Our customized and syndicated market research reports deliver actionable insights that drive sustainable growth. A team of expert-led analysts at FMI continuously tracks emerging trends and events in a broad range of industries to ensure that our clients prepare for the evolving needs of their consumers.Join us as we commemorate 10 years of delivering trusted market insights. Reflecting on a decade of achievements, we continue to lead with integrity, innovation, and expertise.Contact Us:Future Market Insights Inc.Christiana Corporate, 200 Continental Drive,Suite 401, Newark, Delaware - 19713, USAT: +1-347-918-3531For Sales Enquiries: [email protected]Website: https://www.futuremarketinsights.comLinkedIn | Twitter | Blogs | YouTubeSOURCE: Future Market Insights Inc.

DUBLIN--( BUSINESS WIRE )--The "Psoriatic Arthritis - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Psoriatic Arthritis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Psoriatic Arthritis pipeline landscape is provided which includes the disease overview and Psoriatic Arthritis treatment guidelines. The assessment part of the report embraces, in depth Psoriatic Arthritis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Psoriatic Arthritis collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Psoriatic Arthritis R&D. The therapies under development are focused on novel approaches to treat/improve Psoriatic Arthritis. Psoriatic Arthritis Emerging Drugs Chapters This segment of the Psoriatic Arthritis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Psoriatic Arthritis Emerging Drugs Sotyktu: Bristol Myers Squibb Sotyktu (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, representing a new class of small molecules. It is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed Sotyktu to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Sotyktu achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Sotyktu selectively inhibits TYK2 at physiologically relevant concentrations. At therapeutic doses, Sotyktu does not inhibit JAK1, JAK2 or JAK3. Currently, the drug is in the Phase III stage of its development for the treatment of Psoriasis Arthritis. HS-10374: Hansoh BioMedical R&D Company HS-10374 mechanism of action is to inhibit (TYK2) that is tyrosine-kinase 2. TYK2 inhibitors work by blocking the TYK2 protein and the cellular signals that run through it. Those signals can in turn activate other immune proteins and are associated with inflammation. Its route of administration is orally. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Psoriasis Arthritis. si-544: selection si-544, the Companys lead candidate, selectively blocks Kv1.3, a key ion channel expressed disease-associated effector memory T (TEM) cells. Kv1.3 is essential for the chronic activation and proliferation of these cells which escape the control of the immune system and become malignant. TEM cells drive inflammation in many autoimmune diseases, including atopic dermatitis, psoriasis, rheumatoid arthritis, and multiple sclerosis. Currently, the drug is in the Phase I stage of its development for the treatment of Psoriasis Arthritis. Psoriatic Arthritis: Therapeutic Assessment Major Players in Psoriatic Arthritis There are approx. 20+ key companies which are developing the therapies for Psoriatic Arthritis. The companies which have their Psoriatic Arthritis drug candidates in the most advanced stage, i.e. Phase III include, Bristol Myers Squibb. Phases The report covers around 25+ products under different phases of clinical development like Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Psoriatic Arthritis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. Psoriatic Arthritis: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Psoriatic Arthritis therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Psoriatic Arthritis drugs. Psoriatic Arthritis Report Insights Psoriatic Arthritis Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Psoriatic Arthritis Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players Pfizer selectION Therapeutics GmbH Jiangsu HengRui Medicine Co., Ltd. Nimbus Lakshmi, Inc. Hansoh BioMedical R&D Company Bio-Thera Solutions Mylan Inc. ACELYRIN Inc. Key Products PF-06700841 si-544 SHR0302 NDI-034858 HS-10374 BAT2506 MYL-1401A ABY-035 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/v6c9p4 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Delivered First Quarter Total Revenue of $64.8 Million, Driven by Strong Drug Discovery Revenue of $32.6 Million Reports First Subjects Enrolled in Both Ongoing Phase 1 Study of MALT1 Inhibitor SGR-1505 and Newly Initiated Phase 1 Study in Healthy Subjects Cash Position Significantly Strengthened by $147.3 Million Distribution from Sale of Nimbus’s TYK2 Inhibitor to Takeda NEW YORK--(BUSINESS WIRE)-- Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based computational platform is transforming the way therapeutics and materials are discovered, today announced financial results for the first quarter ended March 31, 2023. “We are very pleased with our achievements during the first quarter, which included strong contributions from our software business and our drug discovery collaborations,” stated Ramy Farid, Ph.D., chief executive officer of Schrödinger. “We are making excellent progress across our pipeline of proprietary and collaborative programs. We advanced the first program in our collaboration with BMS to development candidate status, and today reported that we have begun enrollment and dosing in both our ongoing Phase 1 study of SGR-1505 in patients with advanced B cell malignancies and our newly-initiated Phase 1 study in healthy volunteers. The transition to being a clinical-stage company represents a significant milestone for Schrödinger and an important step toward delivering our medicines to patients.” “We delivered a very strong quarter, with software and drug discovery making equal contributions to our revenue result, reflecting our balanced business model. We also made substantial progress in both collaborative and proprietary programs and added capital to our balance sheet, and our partners achieved significant corporate and development milestones further validating our platform,” stated Geoff Porges, MBBS, chief financial officer of Schrödinger. “With our highly differentiated technology, our growing pipeline and our strong cash position, we are well positioned to achieve our goals for 2023 and beyond.” First Quarter 2023 GAAP Financial Results Total revenue for the first quarter increased 33% to $64.8 million, compared to $48.7 million in the first quarter of 2022. Software revenue for the first quarter was $32.2 million, compared to $33.1 million in the first quarter of 2022. Software revenue in the first quarter of 2023 included a small number of multi-year agreements that did not fully offset revenue from multi-year agreements in the first quarter of 2022. Drug discovery revenue was $32.6 million for the first quarter and included a $25 million milestone from BMS, compared to $15.6 million in the first quarter of 2022. Software gross margin increased to 78% for the first quarter, compared to 77% in the first quarter of 2022. Operating expenses were $76.2 million for the first quarter, compared to $56.6 million for the first quarter of 2022. The increase was driven by additional headcount to support the company’s progressing internal pipeline and its software business, CRO expenses, and royalties. Other income for the first quarter was $186.0 million, primarily associated with changes in fair value of equity investments, interest income, and a $147.3 million gain relating to the cash distributions from Nimbus in connection with the sale of Nimbus’s TYK2 inhibitor to Takeda. Other expense for the first quarter of 2022 was $5.8 million driven primarily by changes in the fair value of the company’s equity investments. Net income for the first quarter was $129.1 million, compared to net loss of $34.4 million in the first quarter of 2022. During the first quarter, Schrödinger reported a non-cash tax expense of $26.4 million associated with the cash distribution from Nimbus. At March 31, 2023, Schrödinger had cash, cash equivalents, restricted cash and marketable securities of approximately $532 million, compared to approximately $456 million at December 31, 2022. Three months ended March 31, 2023 2022 % Change (in millions) Total revenue $ 64.8 $ 48.7 33% Software revenue 32.2 33.1 (3%) Drug discovery revenue 32.6 15.6 109% Software gross margin 78 % 77 % Operating expenses $ 76.2 $ 56.6 35% Other income (expense) $ 186.0 $ (5.8 ) – Net income (loss) $ 129.1 $ (34.4 ) – For the three months ended March 31, 2023, Schrödinger reported a non-GAAP net loss of $27.5 million compared to a non-GAAP net loss of $28.3 million for the three months ended March 31, 2022. See “Non-GAAP Information” below and the table at the end of this press release for a reconciliation of non-GAAP net income (loss) to GAAP net income (loss). 2023 Financial Outlook As of May 4, 2023, Schrödinger maintained its financial guidance for the fiscal year ending December 31, 2023: Software revenue growth is expected to be in the range of 13 to 17 percent Drug discovery revenue is expected to range from $70 million to $90 million Software gross margin is expected to be similar to software gross margin for the full year 2022 Operating expense growth in 2023 is expected to be significantly lower than operating expense growth in 2022 and to be similar to revenue growth in 2023 Cash used for operating activities in 2023 is expected to be below cash used for operating activities in 2022 For the second quarter of 2023, software revenue is expected to range from $27 million to $31 million. Recent Highlights Corporate In April, Schrödinger received a $36.0 million distribution, which is the second cash distribution from Nimbus Therapeutics in connection with Takeda’s acquisition of Nimbus Lakshmi, Inc., a wholly-owned subsidiary of Nimbus, and its tyrosine kinase 2 (TYK2) inhibitor, NDI-034858. Schrödinger received the first distribution of $111.3 million in February 2023 for a total distribution of approximately $147.3 million, all of which was recognized as other income in the company’s first quarter 2023 financial results. NDI-034858 is being evaluated for the treatment of multiple autoimmune diseases following positive Phase 2b results in psoriasis. In April, Schrödinger published its inaugural corporate sustainability report. The report highlights the company's vision and approach to corporate sustainability, summarizes the company’s 2022 achievements and discloses key data about its corporate sustainability efforts in alignment with GRI and SASB reporting standards. Pipeline Schrödinger continues to advance its MALT1 inhibitor, SGR-1505, in Phase 1 clinical development. A dose-escalation study designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and early signals of clinical activity of SGR-1505 as a monotherapy is ongoing in patients with relapsed or refractory B-cell malignancies. Today Schrödinger announced that it has also initiated a Phase 1 study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SGR-1505. Schrödinger is continuing to progress its CDC7 inhibitor, SGR-2921, through IND-enabling studies to support a planned IND submission in the first half of 2023. SGR-2921 has exhibited strong anti-tumor activity as a monotherapy and in combination with standard of care agents in multiple preclinical tumor models. Schrödinger continues to advance its Wee1 inhibitor, SGR-3515, through IND-enabling studies to support a potential IND submission in 2024. Schrödinger continues to advance its multi-target collaboration with BMS and today announced that it received a $25 million milestone payment associated with the advancement of the SOS1/KRAS program to development candidate status. This payment was recognized in drug discovery revenue in the first quarter of 2023. Schrödinger’s collaborator, Morphic Therapeutic, made significant progress advancing MORF-057, an oral α4β7 integrin inhibitor, reporting positive topline results of the EMERALD-1 Phase 2a study in adults with moderate to severe ulcerative colitis (UC). MORF-057 achieved the primary endpoint and demonstrated consistent clinical improvement across other key measures with a favorable tolerability profile. The company continues to progress a pipeline of early-stage wholly-owned programs with potential across a broad range of therapeutic areas. Schrödinger is planning to review its drug discovery programs during its Pipeline Day, a virtual and in-person event that will take place on September 28, 2023. Platform Schrödinger scientists published research showing how the company’s computational methods can be used to refine AlphaFold2 structures for hit discovery. While the publication of the open source AlphaFold protein structure database covers the complete human proteome and represents a significant scientific advance, computational methods are required to adequately refine the AlphaFold structures to improve their utility for drug discovery. Schrödinger scientists published a study describing how FEP+ can be used with homology models for protein thermostability predictions, which can extend Schrödinger’s platform and the use of FEP+ thermostability prediction to targets for which an experimental structure is unavailable. Protein engineering for thermostability has a range of applications, including in the design of antibodies and in chemical industries where protein stability requires optimization to enable enzymes to withstand specific chemical conditions or to extend the shelf-life of protein products. Webcast and Conference Call Information Schrödinger will host a conference call to discuss its first quarter 2023 financial results on Thursday, May 4, 2023, at 4:30 p.m. ET. The live webcast can be accessed under "News & Events" in the investors section of Schrödinger’s website, . To access the call by phone, please dial 1-888-396-8049 (domestic) or 1-416-764-8646 (international) and refer to conference ID 21402709. The archived webcast will be available on Schrödinger’s website for approximately 90 days following the event. Non-GAAP Information Included in this press release is certain financial information that has not been prepared in accordance with generally accepted accounting principles in the United States (GAAP). The company presents non-GAAP net income (loss) and non-GAAP net income (loss) per share, which exclude gains and losses on equity investments, changes in fair value, and non-cash income tax benefits and expenses relating to the company’s gains and losses on equity investments. Adjusting net income to exclude the impact of these items results in a financial presentation for the company without the impact of our equity investments. Management believes non-GAAP net income (loss) and non-GAAP net income (loss) per share are useful measures for investors, taken in conjunction with the company’s GAAP financial statements because they provide greater period-over-period comparability with respect to the company’s operating performance, by excluding non-cash mark-to-market and other valuation adjustments for our equity investments, non-recurring cash distributions from our equity investments and the tax impact of these distributions that are not reflective of the ongoing operating performance of the business. However, the non-GAAP measures should be considered only in addition to, not as a substitute for or as superior to, net income (loss) and net income (loss) per share or other financial measures prepared in accordance with GAAP. Other companies in our industry may calculate non-GAAP net income (loss) and non-GAAP net income (loss) per share, differently than we do, limiting their usefulness as comparative measures. For a reconciliation of non-GAAP net income (loss) and non-GAAP net income (loss) per share to GAAP net income (loss) and GAAP net income (loss) per share, respectively, please refer to the tables at the end of this press release. About Schrödinger Schrödinger is transforming the way therapeutics and materials are discovered. Schrödinger has pioneered a physics-based computational platform that enables discovery of high-quality, novel molecules for drug development and materials applications more rapidly and at lower cost compared to traditional methods. The software platform is licensed by biopharmaceutical and industrial companies, academic institutions, and government laboratories around the world. Schrödinger’s multidisciplinary drug discovery team also leverages the software platform to advance a portfolio of collaborative and proprietary programs to address unmet medical needs. Founded in 1990, Schrödinger has approximately 800 employees and is engaged with customers and collaborators in more than 70 countries. To learn more, visit , follow us on LinkedIn and Instagram, or visit our blog, Extrapolations.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 including, but not limited to those statements regarding Schrödinger’s expectations about the speed and capacity of its computational platform, its financial outlook for the fiscal year ending December 31, 2023 and second quarter ending June 30, 2023, its plans to continue to invest in research and its strategic plans to accelerate the growth of its software licensing business and advance its collaborative and proprietary drug discovery programs, the long-term potential of its business, its ability to improve and advance the science underlying its platform, the initiation, timing, progress, and results of its proprietary drug discovery programs and product candidates and the drug discovery programs and product candidates of its collaborators, the clinical potential and favorable properties of its CDC7, MALT1, and Wee1 inhibitors, including SGR-1505, SGR-2921, and SGR-3515, the clinical potential and favorable properties of its collaborators’ product candidates, as well as expectations related to the use of its cash, cash equivalents and marketable securities. Statements including words such as “aim,” “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and statements in the future tense are forward-looking statements. These forward-looking statements reflect Schrödinger’s current views about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to the company and on assumptions the company has made. Actual results may differ materially from those described in these forward-looking statements and are subject to a variety of assumptions, uncertainties, risks and important factors that are beyond Schrödinger’s control, including the demand for its software platform, its ability to further develop its computational platform, its reliance upon third-party providers of cloud-based infrastructure to host its software solutions, factors adversely affecting the life sciences industry, fluctuations in the value of the U.S. dollar and foreign currencies, its reliance upon its third-party drug discovery collaborators, the uncertainties inherent in drug development and commercialization, such as the conduct of research activities and the timing of and its ability to initiate and complete preclinical studies and clinical trials, whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials, uncertainties associated with the regulatory review of IND submissions, clinical trials and applications for marketing approvals, the ability to retain and hire key personnel and the direct and indirect impacts of the ongoing COVID-19 pandemic on its business and other risks detailed under the caption “Risk Factors” and elsewhere in the company’s Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2023, filed with the Securities and Exchange Commission on May 4, 2023, as well as future filings and reports by the company. Any forward-looking statements contained in this press release speak only as of the date hereof. Except as required by law, Schrödinger undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events, changes in expectations or otherwise. Condensed Consolidated Statements of Operations (Unaudited) (in thousands, except for share and per share amounts) Three months ended March 31, 2023 2022 Revenues: Software products and services $ 32,213 $ 33,081 Drug discovery 32,569 15,582 Total revenues 64,782 48,663 Cost of revenues: Software products and services 7,115 7,511 Drug discovery 11,974 13,169 Total cost of revenues 19,089 20,680 Gross profit 45,693 27,983 Operating expenses: Research and development 40,741 27,822 Sales and marketing 9,145 6,671 General and administrative 26,308 22,133 Total operating expenses 76,194 56,626 Loss from operations (30,501 ) (28,643 ) Other income (expense): Gain on equity investments 147,322 — Change in fair value 35,737 (6,164 ) Other income 2,937 339 Total other income (expense) 185,996 (5,825 ) Income (loss) before income taxes 155,495 (34,468 ) Income tax expense (benefit) 26,359 (28 ) Net income (loss) 129,136 (34,440 ) Net income (loss) per share of common and limited common stockholders, basic: $ 1.81 $ (0.48 ) Weighted average shares used to compute net income (loss) per share of common and limited common stockholders, basic: 71,467,097 71,050,432 Net income (loss) per share of common and limited common stockholders, diluted: $ 1.75 $ (0.48 ) Weighted average shares used to compute net income (loss) per share of common and limited common stockholders, diluted: 73,818,611 71,050,432 Condensed Consolidated Balance Sheets (Unaudited) (in thousands, except for share and per share amounts) Assets March 31, 2023 December 31, 2022 Current assets: Cash and cash equivalents $ 233,206 $ 90,474 Restricted cash 4,486 5,243 Marketable securities 294,482 360,613 Accounts receivable, net of allowance for doubtful accounts of $125 and $125 46,691 55,953 Unbilled and other receivables, net for allowance for unbilled receivables of $100 and $100 13,473 13,137 Prepaid expenses 11,396 8,569 Total current assets 603,734 533,989 Property and equipment, net 16,493 14,244 Equity investments 101,539 25,683 Goodwill 4,791 4,791 Intangible assets, net — 587 Right of use assets 105,982 105,982 Other assets 6,234 3,311 Total assets $ 838,773 $ 688,587 Liabilities and Stockholders' Equity: Current liabilities: Accounts payable $ 11,987 $ 9,470 Income taxes payable 26,318 355 Accrued payroll, taxes, and benefits 13,152 24,882 Deferred revenue 51,578 57,931 Lease liabilities 11,810 11,006 Other accrued liabilities 8,562 5,166 Total current liabilities 123,407 108,810 Deferred revenue, long-term 20,348 25,598 Lease liabilities, long-term 104,058 105,485 Other liabilities, long-term 700 800 Total liabilities 248,513 240,693 Stockholders' equity: Preferred stock, $$0.01 par value. Authorized 10,000,000 shares; zero shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively — — Common stock, $$0.01 par value. Authorized 500,000,000 shares; 62,362,015 and 62,163,739 shares issued and outstanding at March 31, 2023 and December 31, 2022 , respectively 623 622 Limited common stock, $$0.01 par value. Authorized 100,000,000 shares; 9,164,193 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively 92 92 Additional paid-in capital 840,446 828,700 Accumulated deficit (250,002 ) (379,138 ) Accumulated other comprehensive loss (899 ) (2,382 ) Total stockholders' equity of Schrödinger stockholders 590,260 447,894 Total liabilities and stockholders' equity $ 838,773 $ 688,587 Condensed Consolidated Statements of Cash Flows (Unaudited) (in thousands) Three Months Ended March 31, 2023 2022 Cash flows from operating activities: Net income (loss) $ 129,136 $ (34,440 ) Adjustments to reconcile net income (loss) to net cash used in operating activities: Gain on equity investments (147,322 ) — Fair value adjustments (35,737 ) 6,164 Depreciation and amortization 1,760 969 Stock-based compensation 10,880 9,134 Noncash investment (accretion) amortization (964 ) 1,504 Gain on disposal of property and equipment — (4 ) Decrease (increase) in assets, net of acquisition: Accounts receivable, net 9,262 2,935 Unbilled and other receivables (336 ) (7,390 ) Reduction in the carrying amount of right of use assets — 1,221 Prepaid expenses and other assets (5,750 ) (7,725 ) Increase (decrease) in liabilities, net of acquisition: Accounts payable 2,468 1,328 Income taxes payable 25,963 43 Accrued payroll, taxes, and benefits (11,730 ) (7,454 ) Deferred revenue (11,603 ) (7,079 ) Lease liabilities (623 ) 489 Other accrued liabilities 3,502 594 Net cash used in operating activities (31,094 ) (39,711 ) Cash flows from investing activities: Purchases of property and equipment (3,580 ) (1,696 ) Purchases of equity investments (4,125 ) — Distribution from equity investment 111,329 — Acquisition, net of acquired cash — (6,427 ) Purchases of marketable securities (58,823 ) (55,068 ) Proceeds from maturity of marketable securities 127,401 99,495 Net cash provided by investing activities 172,202 36,304 Cash flows from financing activities: Issuances of common stock upon stock option exercises 867 908 Contribution by noncontrolling interest — — Net cash provided by financing activities 867 908 Net increase (decrease) in cash and cash equivalents and restricted cash 141,975 (2,499 ) Cash and cash equivalents and restricted cash, beginning of period 95,717 123,267 Cash and cash equivalents and restricted cash, end of period $ 237,692 $ 120,768 Supplemental disclosure of cash flow and noncash information Cash paid for income taxes $ 86 $ 37 Supplemental disclosure of non-cash investing and financing activities Purchases of property and equipment in accounts payable 218 317 Purchases of property and equipment in accrued liabilities 86 343 Acquisition of right to use assets, contingency resolution 1,820 1,513 Acquisition of right of use assets — 1,146 Acquisition of lease liabilities — 1,146 Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) Three Months Ended March 31, 2023 2022 (in thousands, except per share data) Net income (loss) (GAAP) $ 129,136 $ (34,440 ) Income tax expense (benefit) 26,359 — Gain on equity investments (147,322 ) — Change in fair value (35,737 ) 6,164 Non-GAAP net loss $ (27,564 ) $ (28,276 ) Non-GAAP net income (loss) per share of common and limited common stockholders, basic and diluted $ (0.38 ) $ (0.40 ) View source version on businesswire.com: Contacts Jaren Irene Madden (Investors) Schrödinger, Inc. jaren.madden@schrodinger.com 617-286-6264 Allie Nicodemo (Media) Schrödinger, Inc. allie.nicodemo@schrodinger.com 617-356-2325 Source: Schrödinger, Inc. 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