Financial Data and Key Metrics Changes - Earnings per share (EPS) for Q1 2025 were $1.05, an increase of nearly 11% compared to $0.95 in Q1 2024, affirming the company's full-year EPS guidance of 8% growth [7][12] - Consolidated reported earnings were $1.50 per share, up $0.10 per share versus the same period in 2024, with revenues higher by $0.44 per share due to authorized rate increases and acquisitions [13][14] - Operating costs increased by $0.15 per share, primarily due to employee-related costs and acquisition-related expenses [14] Business Line Data and Key Metrics Changes - The company achieved a constructive settlement in the general rate case in Missouri, with an annualized revenue increase of $63 million expected [15] - In Virginia, a settlement approved a $15 million annualized increase in water and wastewater revenues [15] Market Data and Key Metrics Changes - The company continues to expect to grow its dividend at 7% to 9% per year, in line with its EPS growth target [11] - The total debt to capital ratio was 58%, within the target of less than 60%, with strong credit ratings affirmed by S&P and Moody's [21] Company Strategy and Development Direction - The company aims for long-term earnings and dividend growth of 7% to 9%, driven by a capital investment program targeting approximately $3.3 billion in 2025 [10][22] - The company is focused on infrastructure investments, particularly in PFAS remediation and lead service line replacement, while maintaining a strong regulatory and operational execution [22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to execute financial and operational plans, with no expected material impact from recent tariff-related announcements [20] - The company highlighted the need for significant investments in U.S. water infrastructure, estimating a total of $625 billion over the next twenty years [29] Other Important Information - The Board approved an increase in the quarterly cash dividend from $0.765 to $0.825 per share, marking an 8.2% increase [11] - The company is well-positioned for growth through acquisitions, with approximately 37,000 customer connections under agreement [26] Q&A Session Summary Question: Thoughts on pulling forward 2026 equity issuance - Management stated there are no plans to pull forward equity issuance and will evaluate the market as needed [37] Question: Acquisition outlook under potential recession - Management expects a continuous flow of acquisition opportunities, potentially driven by recession or reduced federal funding [38] Question: Update on California rate case - Management did not disclose the percentage increase for the California rate case and confirmed a separate proceeding for cost of capital [43][44] Question: Update on California desalination project - Management confirmed that the last major permit approval was received, and they expect to break ground on the desalination project this year [49] Question: Legislative progress and opportunities - Management did not quantify the opportunities from legislative changes but noted they would help earned returns in each state [56]

Business Overview - Agios views PYRUKYND® as having a multi-billion dollar market opportunity [9] - Agios aims to maximize the potential of the PYRUKYND® franchise and progress key pipeline programs in 2025 [11] - Agios anticipates several clinical and regulatory catalysts in 2025, including a potential FDA approval for PYRUKYND® in thalassemia with a PDUFA goal date of September 7, 2025 [13] Clinical Development - Approximately 67% of thalassemia patients are non-transfusion dependent, representing about 4,000 adults in the U S [19] - Approximately 33% of thalassemia patients are transfusion dependent, representing about 2,000 adults in the U S [19] - Agios's PYRUKYND® has the potential to be the first and only approved therapy for all subtypes of thalassemia [23] - The Phase 3 RISE UP study of PYRUKYND® in sickle cell disease completed enrollment in October 2024, with topline data expected in late 2025 [31] - Tebapivat's Phase 2b study in lower-risk MDS expects patient enrollment completion in late 2025 [34, 41] Commercial Performance & Financials - PYRUKYND® net revenue was $8 7 million for Q1 2025, compared to $8 2 million in Q1 2024 [68] - Agios had $1 4 billion in cash, cash equivalents, and marketable securities as of March 31, 2025 [68, 74]

Core Viewpoint - Regeneron Pharmaceuticals reported disappointing first-quarter 2025 results, with adjusted EPS of $8.22, missing estimates and down 14% year-over-year, primarily due to lower revenues and higher operating expenses [1][2][17] Financial Performance - Total revenues decreased 4% year-over-year to $3 billion, missing the Zacks Consensus Estimate of $3.27 billion, driven by lower sales of Eylea and Libtayo [2][17] - Eylea sales in the U.S. plummeted 39% year-over-year to $736 million, impacted by increased competition and market share loss [4][17] - Total Eylea and Eylea HD sales in the U.S. were $1 billion, down 26% year-over-year, also missing estimates [7][17] - Collaboration revenues from Sanofi and Bayer totaled $1.53 billion, up 20.9% year-over-year, exceeding estimates [8][9] Product Performance - Sanofi's collaboration revenues increased 30% to $1.2 billion, driven by higher Dupixent sales, which rose 19% year-over-year to $3.7 billion [9] - Libtayo sales were $285.1 million, up 8% year-over-year, but missed estimates [10] - Eylea HD generated $307 million in revenues, a 54% increase year-over-year, but total Eylea and Eylea HD sales were still down significantly [6][7] Cost and Expenses - Gross margin decreased to 85% from 89% due to higher inventory write-offs and reserves [11] - Adjusted R&D expenses rose 6% year-over-year to $1.2 billion, while adjusted SG&A expenses decreased 8% to $537 million [11] Shareholder Actions - The board authorized a new share repurchase program for up to $3 billion, with $1.052 billion repurchased in Q1 2025 [12] - A cash dividend of $0.88 per share was declared in April 2025 [12] Regulatory Updates - The FDA approved a label expansion for Dupixent and accepted applications for Eylea HD and other drugs, but also issued complete response letters for some applications [13][14][15][16] Strategic Developments - Regeneron entered a 10-year agreement with Fujifilm Diosynth Biotechnologies to enhance manufacturing capacity in the U.S. [19]

Core Viewpoint - Milestone Pharmaceuticals (MIST) received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for CARDAMYST (etripamil) nasal spray, intended for treating paroxysmal supraventricular tachycardia (PSVT) [1][2] Regulatory Issues - The CRL does not raise concerns about the clinical safety or efficacy of etripamil but highlights two Chemistry, Manufacturing, and Controls (CMC) issues that need to be resolved before approval [2][11] - The first issue involves nitrosamine impurities, with the FDA requesting additional data based on new draft guidance issued after MIST's NDA submission [3] - The second issue relates to a facility inspection involved in the drug's release testing, which underwent a change in ownership during the NDA review, necessitating a compliance evaluation [4] Market Reaction - Following the CRL issuance, MIST's shares fell by 66.2%, with a year-to-date loss of 67.8%, contrasting with the industry's growth of 2.2% [2][7] - Analysts remain cautiously optimistic about the drug's prospects, suggesting a potential commercial launch in 2026, delayed from the original expectation of mid-2025 [8][11] Company Response and Financial Position - MIST has expressed its intent to request a Type A meeting with the FDA to clarify the path forward and is committed to addressing the outstanding issues [9] - As of December 31, 2024, MIST reported $69.7 million in cash and short-term investments, providing a runway for ongoing development efforts, although additional capital may be needed if delays continue [10] Investor Perspective - The CRL is viewed as a temporary obstacle rather than a fundamental rejection of CARDAMYST's therapeutic potential, with the absence of clinical concerns being a positive indicator for eventual approval [11]

Core Insights - The global membrane chromatography market is projected to grow from an estimated USD 324.4 million in 2024 to USD 779.3 million by 2030, with a compound annual growth rate (CAGR) of 16.0% from 2025 to 2030 [3][7]. Market Overview - The growth of the membrane chromatography market is primarily driven by the increasing demand for biopharmaceuticals and a heightened regulatory focus on cleaning validation for downstream purification processes [3][4]. - Membrane chromatography offers significant advantages over traditional column chromatography, including higher binding capacities and reduced buffer consumption, which are critical for optimizing biopharmaceutical production [3][4]. Regulatory Environment - Regulatory approvals for biopharmaceutical manufacturing are fueling market growth, as evidenced by Boehringer Ingelheim Biopharmaceuticals China's successful pre-approval inspections by the European Medicines Agency and the U.S. Food and Drug Administration in April 2024 [5]. - The increasing endorsement of biopharmaceuticals by regulatory bodies is driving demand for membrane chromatography [5]. Research and Development - The biopharmaceutical industry's annual R&D spending exceeds USD 202 billion, significantly outpacing other sectors, which underscores the commitment to innovation and the growing number of product launches [6]. - Innovations such as Waters Corporation's introduction of the XBridge Premier GTx BEH SEC columns in August 2023 for gene therapy applications exemplify advancements in membrane chromatography technology [6]. Market Segmentation - The report segments the global membrane chromatography market based on product, technique, end use, and region, providing a comprehensive analysis of trends and forecasts from 2018 to 2030 [2][8]. - Key product segments include capsules, cassettes, cartridges, syringe filters, and membrane filters, among others [8][10]. Competitive Landscape - The competitive landscape includes major players such as 3M, Asahi Kasei, Danaher, Merck, and Thermo Fisher Scientific, highlighting the diverse market participants and their strategic positioning [10][12].

As filed with the Securities and Exchange Commission on February 10, 2025. Registration No. 333-282324 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________ AMENDMENT NO. 7 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 __________________________________________ APIMEDS PHARMACEUTICALS US, INC. (Exact name of registrant as specified in its charter) __________________________________________ | Delaware | 2834 | 85-1099700 | | - ...

As filed with the Securities and Exchange Commission on February 6, 2025. Registration No. 333-282324 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________ AMENDMENT NO. 6 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 __________________________________________ APIMEDS PHARMACEUTICALS US, INC. (Exact name of registrant as specified in its charter) __________________________________________ | Delaware | 2834 | 85-1099700 | | -- ...

As filed with the Securities and Exchange Commission on January 29, 2025. Registration No. 333-282324 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________ AMENDMENT NO. 5 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 __________________________________________ APIMEDS PHARMACEUTICALS US, INC. (Exact name of registrant as specified in its charter) __________________________________________ | Delaware | 2834 | 85-1099700 | | -- ...

As filed with the Securities and Exchange Commission on January 8, 2025. Registration No. 333-282324 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________ AMENDMENT NO. 4 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 __________________________________________ APIMEDS PHARMACEUTICALS US, INC. (Exact name of registrant as specified in its charter) __________________________________________ | Delaware | 2834 | 85-1099700 | | --- ...

As filed with the Securities and Exchange Commission on December 19, 2024. Registration No. 333-282324 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________ AMENDMENT NO. 3 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 __________________________________________ APIMEDS PHARMACEUTICALS US, INC. (Exact name of registrant as specified in its charter) __________________________________________ | Delaware | 2834 | 85-1099700 | | - ...