How do we know if we are living in a miracle moment. And if we are, what should we do. On July 27th, 2023, I received an email asking me if I wanted to be interviewed by Oprah Winfrey for a special she was doing about obesity.It is an incredible time to be a physician scientist specializing in obesity. After decades of struggling to improve the health of our patients, we finally have effective new medications for this disease. Until 2023, my research focused on the care of obesity was only published in acad ...

It's Monday afternoon and I am meeting Donna for the first time in my busy clinic at Boston Healthcare for the Homeless program. Donna can't sit still. She's twisting her scarf and her hands and she appears to be on the verge of tears as she tells me more about her situation.She had been doing great in a treatment program, but was kicked out over an argument. She's been back in the shelter, and then last night, all of her belongings and medication were stolen from underneath her bunk. This is not at all the ...

Core Viewpoint - Gilead Sciences, Inc. (GILD) has demonstrated strong stock performance, gaining 27.2% over the past six months, significantly outperforming the industry and broader market indices [1][7]. Gilead's HIV Portfolio - The recent FDA approval of lenacapavir, branded as Yeztugo, introduces the first and only twice-yearly injectable option for HIV prevention in the U.S., enhancing Gilead's market-leading HIV treatment portfolio [2][4]. - Gilead's flagship drug, Biktarvy, holds over 51% market share in the U.S. treatment market, while Descovy maintains over 40% market share in the PrEP market [3][4]. - Yeztugo addresses barriers to PrEP adoption, such as adherence and healthcare access, and is expected to increase uptake among underserved populations [5][4]. Financial Performance and Growth - Gilead's stock has outperformed the industry, sector, and S&P 500 index, supported by the FDA approval of Yeztugo and rising earnings estimates [6][7]. - Earnings estimates for Gilead have increased, with the 2025 bottom-line estimate rising to $7.92 from $7.91, and the 2026 estimate improving to $8.48 from $8.39 [15]. Liver Disease Portfolio - Gilead's liver disease portfolio has been strengthened by the FDA approval of seladelpar for primary biliary cholangitis (PBC), which has shown encouraging initial uptake [9][10]. Oncology Business Challenges - Gilead's oncology portfolio faces challenges, particularly in the Cell Therapy franchise due to competitive pressures, but positive results from the ASCENT-03 study on Trodelvy may bolster future growth [11][12]. Strategic Positioning - Gilead's strategic collaborations and acquisitions, including a partnership with Merck for HIV treatment, position the company for continued growth despite competitive pressures from other firms like GSK [17][18]. - The company maintains a strong cash position of $7.9 billion, supporting its attractive dividend yield of 2.83%, which is sustainable [19].

Altimmune (ALT) 2025 Conference June 04, 2025 09:55 AM ET Speaker0 Alright. Welcome everyone to twenty twenty five Jefferies Global Healthcare Conference. My name is Roger Song, one of the senior analyst covers Mecha Biotech in The US. It's my great pressure to have the fireside chat with our next presenting company, Altimmune, the CEO of the Pennant and CMO, Scott Harris. Welcome, gentlemen. Speaker1 Thank you. Speaker0 Awesome. Yeah. So, we know know lots eyes on the upcoming phase two MeSH data, But befo ...

Core Viewpoint - Gilead Sciences, Inc. has demonstrated strong performance in a volatile market, with shares up 21.1% year-to-date, significantly outperforming the industry and the S&P 500 Index, which declined by 4.7% [1][8]. Group 1: HIV Market Leadership - Gilead is a dominant player in the HIV market, with its flagship drug Biktarvy accounting for over 51% of the treatment market share in the U.S. [4] - The company’s Descovy for pre-exposure prophylaxis (PrEP) maintains over 40% market share in the U.S. [5] - The FDA has accepted new drug applications for lenacapavir for HIV prevention, with a target action date of June 19, 2025, which could enhance Gilead's HIV franchise [5][6]. Group 2: Liver Disease Portfolio - The FDA approval of seladelpar (Livdelzi) for primary biliary cholangitis (PBC) strengthens Gilead's liver disease portfolio and validates its CymaBay acquisition [7][9]. Group 3: Oncology Business Challenges - Gilead's oncology portfolio, including the Cell Therapy franchise and Trodelvy, faces competitive pressures, particularly in the U.S. and Europe, which are expected to continue into 2025 [10]. - Despite challenges, positive results from the phase III ASCENT-03 study on Trodelvy indicate potential for improvement in the oncology business [11]. Group 4: Financial Performance and Estimates - Gilead's shares trade at a price/earnings ratio of 13.70x forward earnings, lower than the large-cap pharma industry's average of 14.62x but higher than its historical mean of 10.53x [12]. - Earnings estimates for Gilead have increased, with the 2025 bottom-line estimate rising to $7.91 from $7.87, and the 2026 estimate improving to $8.39 from $8.31 [14]. Group 5: Strategic Positioning and Dividends - Gilead's strategic deals and acquisitions are aimed at diversifying its business, although Biktarvy sales may face pressure due to Medicare Part D redesign [17]. - The company has a strong cash position of $7.9 billion as of March 31, 2025, and has consistently increased dividends, declaring a quarterly dividend of $0.79 per share for Q2 2025, indicating a sustainable yield of 2.91% [18].

Financial Data and Key Metrics Changes - The company ended Q1 2025 with $150 million in cash, cash equivalents, and short-term investments, an increase from $132 million at the end of 2024, primarily due to $35 million raised from the ATM facility [22][20] - R&D expenses for Q1 2025 were $15.8 million, down from $21.5 million in the same period of 2024, with $9.2 million specifically related to pemidutide development [22][24] - General and administrative expenses rose to $6 million from $5.3 million in Q1 2024, mainly due to increased non-cash stock compensation [23] Business Line Data and Key Metrics Changes - The company is focused on the development of pemidutide, with significant progress in the NASH program, including the upcoming readout of the IMPACT Phase 2b MATCH trial [8][12] - The trial enrolled 212 participants with biopsy-confirmed F2F3 NASH, enhancing the study's power [12] Market Data and Key Metrics Changes - The company is expanding into alcohol use disorder (AUD) and alcohol liver disease (ALD), with plans for Phase II trials in these areas [9][10] - The market research indicates that a drug like pemidutide, which reduces alcohol consumption and liver inflammation, would be well-received by patients and physicians [18] Company Strategy and Development Direction - The company aims to establish pemidutide as a foundational treatment across multiple fibrotic liver diseases, focusing on NASH, AUD, and ALD [10][19] - The strategic partnership with Hercules Capital for a $100 million credit facility is intended to support the ongoing development of pemidutide [9][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the trial's key efficacy and safety objectives for pemidutide, which could become the first therapy to achieve statistical significance on NASH endpoints at 24 weeks [8][13] - The company anticipates 2025 to be a transformative year, with significant milestones expected from the IMPACT trial and the initiation of Phase II trials for AUD and ALD [19][24] Other Important Information - The company is preparing for an end-of-Phase II meeting with the FDA in Q4 2025, which will discuss the potential for accelerated approval in F4 cirrhosis [78][79] - The company has a large safety database for pemidutide, which may allow for more efficient trial designs in Phase III [73] Q&A Session Summary Question: Can you provide commentary on the distribution of F2 and F3 in the Phase 2b population? - Management indicated that the demographics of the final qualifying population are similar to other studies, but precise numbers will be presented later [28][29] Question: What is the ideal population for pemidutide post-IMPACT? - The focus is on treating NASH with obesity, as a significant percentage of NASH patients are obese, which is a key factor in the treatment strategy [30][31] Question: How are you handling study discontinuations? - Management reported satisfaction with the discontinuation rates and stated that data will be available at the time of the readout [36] Question: How important is weight loss in this study? - Weight loss is crucial, as it addresses comorbidities associated with NASH, and the company aims to achieve clinically meaningful weight loss [40][41] Question: What are the expected placebo responses for fibrosis and NASH resolution endpoints? - Management noted that placebo responses have varied historically, but they expect to control the placebo response effectively in their trial [87][88] Question: Will you discuss NASH F4 cirrhosis with the FDA? - The company intends to discuss F4 with the FDA and believes they will be successful in this area [78][79] Question: Can you confirm the cash runway with the Hercules facility? - The facility will provide $15 million upfront, with additional tranches available, potentially extending the cash runway into Q3 2026 [81][82]

Financial Performance - Total revenue reached $65 million, reflecting a 63% increase adjusting for a one-time settlement agreement milestone received in Q1 2024[9] - U S net product sales grew by 41% to $34 9 million[10] - Collaboration revenue was $30 1 million[34] Prescription Trends - Q1 2025 script growth increased by 2% compared to Q4 2024[15, 16] - Early Q2 2025 prescription volume is tracking approximately 8% higher than Q1 2025[16] Market Access and Clinical Validation - The company tripled the U S field reimbursement team to 15 specialists[12] - Over 30 major healthcare plans removed prior authorizations and expanded formulary coverage for NEXLETOL and NEXLIZET[12] Global Expansion - Products are approved in 40 countries globally[21] - Approximately 472,500 patients have been reached internationally through February 2025[24] Pipeline Development - The company is developing a triple combination product with an estimated LDL-C reduction of approximately 60%-70%[19] - A program targeting Primary Sclerosing Cholangitis (PSC) is in development, with an IND planned for 2026, addressing a market opportunity estimated at over $1 billion annually[27, 30]

OPKO Health (OPK) Q1 2025 Earnings Call April 30, 2025 04:30 PM ET Company Participants Yvonne Briggs - Investor Relations and Corporate Development ExecutivePhillip Frost - Chairman & CEOElias Zerhouni - President & Vice ChairmanAdam Logal - SVP & CFOJeffrey Cohen - MD - Equity ResearchBilly Smith - Equity ResearchMichael Petusky - Managing Director Conference Call Participants James Stamos - AnalystYi Chen - Managing Director & Senior AnalystEdward Tenthoff - Sr. Research AnalystYale Jen - Senior Managing ...