Ironwood Pharmaceuticals (IRWD) reported an adjusted loss of 14 cents per share for the first quarter of 2025, which was wider than the Zacks Consensus Estimate of a loss of 5 cents. The company had reported an adjusted loss of 2 cents per share in the year-ago quarter.Total revenues in the first quarter were $41.1 million, which also missed the Zacks Consensus Estimate of $59 million. Revenues decreased around 45.1% year over year. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)Sh ...

NASDAQ:ZLAB | HKEX:9688 © 2025. Zai Lab. All Rights Reserved. Forward-Looking Statements This presentation contains forward-looking statements, including statements relating to our strategy and plans; potential of and expectations for our business, commercial products, and pipeline programs; our goals, objectives, and priorities and our expectations under our growth strategy (including our expectations regarding our commercial products and launches, clinical stage products, revenue growth / CAGR, profitabil ...

NEW YORK, May 08, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, announces that its Founder and Chief Scientific Officer, Michael Newman, Ph.D., will serve as an Expert Speaker and Chair of Day 2 at the 6th Annual Cytokine-Based Drug Development Summit taking place May 15-16, 2025 in Boston. Dr. Newman will deliver a presentation titled “Pulsed Cytokine Delivery for Anti-Tum ...

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $50 million, a 5% increase from $47.5 million in Q1 2024, primarily due to growth in Fanapt revenue from the bipolar commercial launch [18][19] - Net loss for Q1 2025 was $29.5 million, compared to a net loss of $4.1 million in Q1 2024, reflecting increased expenses related to commercial activities and a $15 million payment for a licensing agreement [23][24] - Operating expenses in Q1 2025 were $91.1 million, up from $56.7 million in Q1 2024, driven by higher R&D and SG&A expenses [25] Business Line Data and Key Metrics Changes - Fanapt net product sales were $23.5 million in Q1 2025, a 14% increase from $20.6 million in Q1 2024, with total prescriptions increasing by approximately 14% [19][9] - HETLIOZ net product sales were $20.9 million in Q1 2025, a 4% increase from $20.1 million in Q1 2024, despite ongoing generic competition [20] - PONVORY net product sales were $5.6 million in Q1 2025, an 18% decrease from $6.8 million in Q1 2024, attributed to a decrease in volume [21] Market Data and Key Metrics Changes - Fanapt reached a milestone of 2,000 weekly prescriptions by the week of April 25, 2025, making it one of the fastest-growing atypical antipsychotics [9][26] - HETLIOZ continues to retain the largest market share despite generic competition for over two years [20] - The company expanded its psychiatry sales force to approximately 300 representatives, enhancing its market reach [27] Company Strategy and Development Direction - Vanda is in a new growth phase with multiple commercialized products and a robust pipeline, including recent NDA filings for Tradipitant and Vicente [7][8] - The company is focusing on expanding its commercial infrastructure and anticipates significant revenue growth from its product launches in 2025 and beyond [26][30] - Vanda expects to have six products commercially available by 2026, indicating a strong pipeline and market potential [29][30] Management's Comments on Operating Environment and Future Outlook - Management highlighted the strong market response to the commercial launch of Fanapt, with significant increases in new patient starts and total prescriptions [26][27] - The company anticipates variability in HETLIOZ revenue due to ongoing generic competition and inventory stocking changes [20][30] - Management reiterated its revenue guidance for 2025, expecting total revenues from key products to be between $210 million and $250 million, reflecting a growth of 626% compared to 2024 [30][31] Other Important Information - The company has initiated direct-to-consumer campaigns for both Fanapt and PONVORY, receiving positive feedback and increasing brand awareness [46] - Vanda is actively working through D120 questions from the EMA regarding its marketing applications for Fanapt and HETLIOZ [51] Q&A Session Summary Question: What kind of placebo adjusted change on MADRS or HAM D would be desired for a competitive profile for milseperidone? - Management indicated that they have not prespecified the margin, noting variability in major depression studies [35] Question: Can you provide details on the Phase III social anxiety study design? - Management stated that the study is set to begin in Q3 and referred to previously conducted studies for design details [36] Question: What is the latest strategy for tradipitant for gastroparesis? - Management explained the complexity of the FDA review process and that a new filing is not required at this time [39][41] Question: How long will the direct-to-consumer campaign run and how is its effectiveness measured? - Management confirmed the campaign's focus on bipolar disorder and PONVORY, noting positive feedback and increased awareness [45][46] Question: What is the market opportunity for Bisanti in major depressive disorder? - Management acknowledged that Bisanti would compete directly with CAPLYTA, emphasizing its once-daily dosing advantage [58] Question: When might the long-acting injectable formulations of Bisanti enter the clinic? - Management indicated that the long-acting injectable for Fanapt is initiating Phase III studies, while Bisanti is still in the formulation phase [61]

Inotiv (NOTV) Q2 2025 Earnings Call May 07, 2025 04:30 PM ET Company Participants Steven Halper - Managing DirectorRobert Leasure - CEO, President & DirectorBeth Taylor - SVP of Finance & CFOJohn Sagartz - Chief Strategy Officer & DirectorNelson Cox - Equity Research AssociateDavid Windley - Managing Director Conference Call Participants Matt Hewitt - Senior Research Analyst Operator Good day, everyone, and welcome to today's Innotiv Second Quarter Fiscal twenty twenty five Earnings Call. At this time, all ...

Financial Data and Key Metrics Changes - For Q2 of fiscal 2025, total revenue was $124.3 million, a 4.4% increase from $119 million in Q2 of fiscal 2024, primarily driven by an increase in RMS segment revenue [8][25] - Adjusted EBITDA for Q2 was $8 million, or 6.4% of total revenue, compared to $3.1 million, or 2.6% of total revenue in the same quarter last year [27][28] - Consolidated net loss attributable to common shareholders was $14.9 million, or a loss of $0.44 per diluted share, compared to a loss of $48.1 million, or $1.86 per diluted share in Q2 of fiscal 2024 [27] Business Line Data and Key Metrics Changes - RMS segment revenue increased by $6.6 million, or 9.1%, compared to Q2 of fiscal 2024, mainly due to higher NHP volumes sold [25][26] - DSA revenue decreased to $45.3 million from $46.6 million in Q2 of fiscal 2024, primarily due to a decline in general toxicology services revenue [26] - DSA net new orders were $44.5 million, a 27% increase over Q2 of fiscal 2024, with a book to bill ratio of 1.01:1 [26][28] Market Data and Key Metrics Changes - The company noted geopolitical and macroeconomic risks affecting the industry, but expects continued year-over-year revenue and adjusted EBITDA growth for the next two quarters [9][23] - The company has not seen material changes in demand due to current tariffs, although there is some cost inflation linked to tariffs [22][23] Company Strategy and Development Direction - The company is focused on client satisfaction, integration of scientific services, and site optimization plans to improve operational efficiency and margins [7][10] - A revised RMS site optimization plan is expected to yield annual cost savings of $6 million to $7 million, with completion anticipated by March 2026 [11][12] - The company is adapting to FDA announcements regarding drug development and animal testing, positioning itself to leverage new methodologies [18][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the level of quoting and awards in the DSA segment, expecting improvements in margins starting in Q3 of fiscal 2025 [49][86] - The company is monitoring NIH funding impacts but has not seen significant changes in business yet [52][54] - Management remains confident in the company's ability to navigate geopolitical and macroeconomic uncertainties while creating value for clients and shareholders [23][24] Other Important Information - The company plans to hold an Investor Day on May 29 to further discuss its strategic plan and focus on client excellence [87] - The company has made significant investments in acquisitions and site optimizations to prepare for future growth [7][10] Q&A Session Summary Question: Changes in marketing strategies post-FDA announcement - Management has integrated new services into their discovery sales process and is seeing some growth, though not as rapid as expected [35][36] Question: Focus areas in the revised RMS optimization plan - The revised plan aims to improve efficiencies and reduce costs, with a focus on maximizing existing resources rather than expanding capacity [40][41] Question: Current demand trends and quoting activity - Management reported a positive start to the current quarter, with strong quoting and closing activity [46][49] Question: Impact of NIH funding on customer mix - There has been no dramatic impact from NIH funding yet, with some customers increasing orders while others have reduced them [52][54] Question: DSA margin improvement timeline - Management expects to see benefits from identified margin improvement areas sooner rather than later, with some improvements already noted [66][68]

Cytokinetics, Incorporated (CYTK) reported a net loss of $1.36 per share for the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $1.41. In the year-ago quarter, the company reported a net loss of $1.33 per share. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)The year-over-year deterioration was due to higher operating expenses.Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and comme ...

Vertex Pharmaceuticals Incorporated (VRTX) reported adjusted earnings of $4.06 per share for the first quarter of 2025, missing the Zacks Consensus Estimate of $4.22. Earnings declined 14.7% on a year-over-year basis.The company reported total revenues of $2.77 billion for the first quarter, which missed the Zacks Consensus Estimate of $2.82 billion. Total revenues rose 3% year over year, primarily driven by higher sales of Trikafta/Kaftrio (marketed as Kaftrio in Europe). (Find the latest EPS estimates and ...

Advancing Life-Changing Discoveries in Neuroscience Neurocrine Biosciences (Nasdaq: NBIX) Q1 2025 Earnings Presentation May 5,2025 Safe Harbor and Forward-Looking Statements In addition to historical facts, this presentation contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may br ...

Vertex Pharmaceuticals (VRTX) Q1 2025 Earnings Call May 05, 2025 04:30 PM ET Company Participants Susie Lisa - SVP - Investor RelationsReshma Kewalramani - CEO, President & DirectorStuart Arbuckle - EVP & COODuncan McKechnie - SVP - North America Commercial OperationsCharles Wagner - EVP & CFOGeoff Meacham - Managing DirectorMichael Yee - Managing DirectorLiisa Bayko - Managing DirectorDavid Risinger - Senior Managing Director, BiopharmaGena Wang - MD - Biotech Equity Research Conference Call Participants J ...