Investors interested in stocks from the Medical - Biomedical and Genetics sector have probably already heard of Alkermes (ALKS) and CSL Limited Sponsored ADR (CSLLY) . But which of these two stocks presents investors with the better value opportunity right now? Let's take a closer look.Everyone has their own methods for finding great value opportunities, but our model includes pairing an impressive grade in the Value category of our Style Scores system with a strong Zacks Rank. The proven Zacks Rank puts an ...

Core Insights - Valneva SE has entered into an exclusive agreement with CSL Seqirus for the marketing and distribution of its three proprietary vaccines in Germany [1][2] - The agreement includes the commercialization of Valneva's chikungunya vaccine IXCHIQ® starting July 2025, and its Japanese Encephalitis vaccine IXIARO® and cholera/ETEC vaccine DUKORAL® from January 2026 [2] - This new agreement replaces a previous partnership with Bavarian Nordic, which is set to conclude at the end of December 2025 [2][3] Company Performance - Valneva's product sales reached €48.6 million in Q1 2025, with €42.8 million coming from proprietary vaccines [4] - The company anticipates product sales to grow to €170-180 million in 2025, contributing to positive cash flows for its commercial business [4] Strategic Focus - The partnership with CSL Seqirus is expected to enhance Valneva's commercial sales in Germany, leveraging CSL's strong presence in the travel vaccine market [4] - Valneva specializes in developing vaccines for infectious diseases, focusing on unmet medical needs and applying expertise across multiple vaccine modalities [5][6] Pipeline Development - Revenues from the commercial business support the advancement of Valneva's vaccine pipeline, which includes a Lyme disease vaccine candidate partnered with Pfizer and a Shigella vaccine candidate [7]

Core Viewpoint - CSL has received FDA approval for ANDEMBRY®, a novel treatment for hereditary angioedema (HAE), marking a significant advancement in the management of this rare genetic disorder [1][3][11] Group 1: Product Overview - ANDEMBRY is the first monoclonal antibody developed entirely by CSL, targeting factor XIIa to prevent HAE attacks in patients aged 12 and older [1][3][11] - The treatment offers once-monthly subcutaneous self-injection, providing a convenient administration method [1][3] - ANDEMBRY has shown a median reduction of more than 99% in HAE attacks compared to placebo, with a least squares mean reduction of 89.2% [6][7] Group 2: Clinical Trial Data - The approval is based on data from the pivotal Phase 3 VANGUARD trial, which demonstrated the efficacy and safety of ANDEMBRY [3][12] - In the pivotal trial, 62% of patients treated with ANDEMBRY remained attack-free throughout the treatment period [7] - The most common adverse reactions reported were nasopharyngitis and abdominal pain, with injection-site reactions occurring in 14% of patients [4][7] Group 3: Market Impact and Availability - ANDEMBRY's approval expands CSL's HAE franchise and reinforces the company's commitment to innovation in the HAE community [6][8] - The product is set to launch commercially immediately, with availability expected before the end of June 2025 [9] - ANDEMBRY has also received approvals in multiple regions, including Australia, the UK, the EU, Japan, Switzerland, and the UAE [8]

Core Viewpoint - Investors in the Medical - Biomedical and Genetics sector should consider Kamada (KMDA) and CSL Limited Sponsored ADR (CSLLY) for potential value opportunities, with KMDA currently presenting a stronger case for investment [1] Valuation Metrics - Kamada has a Zacks Rank of 2 (Buy), indicating a stronger earnings outlook compared to CSL Limited Sponsored ADR, which has a Zacks Rank of 4 (Sell) [3] - KMDA's forward P/E ratio is 22.98, while CSLLY's forward P/E ratio is 24.59, suggesting that KMDA may be undervalued relative to CSLLY [5] - The PEG ratio for KMDA is 0.92, indicating better expected earnings growth relative to its price, whereas CSLLY has a PEG ratio of 1.96 [5] - KMDA's P/B ratio is 1.59, significantly lower than CSLLY's P/B ratio of 4.02, further supporting KMDA's valuation advantage [6] - Based on these metrics, KMDA holds a Value grade of A, while CSLLY has a Value grade of D, reinforcing KMDA's position as the superior value option [6]

European Commission converts conditional approval of FILSPARI (sparsentan) into standard marketing authorization for the treatment of IgA Nephropathy (IgAN) Decision follows positive recommendation from Committee for Medicinal Products for Human Use (CHMP) from February 2025EU approval is based on the complete data set from the phase-III PROTECT studyST. GALLEN, Switzerland and SAN DIEGO, April 29, 2025 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) are pleased to announce that the ...

- KOSTAIVE represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trialsWALTHAM, Mass. and SAN DIEGO, Feb. 14, 2025 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) and sa-mRNA pioneer Arcturus Therapeutics (Nasdaq: ARCT) today announced that the European Commission has granted marketing authorization for KOSTAIVE ® (ARCT ...

Fiona Mead Company Secretary For further information, please contact: Investors Media Chris Cooper Investor Relations CSL Limited P: +61 455 022 740 E: chris.cooper@csl.com.au For immediate release 11 February 2025 Results Presentation for the Half-year ended 31 December 2024 Melbourne, Australia – CSL (ASX:CSL; USOTC:CSLLY) Please find attached the slides for the presentation on the half year results that will be given by the Chief Executive Officer and the Chief Financial Officer shortly. The briefing wil ...

Financial Data and Key Metrics Changes - Revenue for the first half of fiscal year 2025 was AUD 8.5 billion, up 5% at constant currency [8] - NPATA was AUD 2.1 billion, also up 5%, while net profit after tax increased by 7% to AUD 2 billion [8][41] - Gross profit was AUD 4.728 billion, reflecting a 5% increase [41] - Cash flow from operations rose by 18% to AUD 1.259 billion [44] Business Line Data and Key Metrics Changes - CSL Behring reported a strong growth of 10%, driven by a 15% increase in the Ig franchise and a 9% growth in the albumin portfolio [9][13] - CSL Seqirus experienced a revenue decline of 9%, primarily due to decreased immunization rates in the US [24][48] - CSL Vifor's revenue increased by 6%, supported by growth in iron and nephrology products [31][48] Market Data and Key Metrics Changes - Immunization rates in the US have significantly declined, particularly in the 18 to 64 age group, impacting CSL Seqirus [11][25] - Vaccination rates outside the US are stabilizing, providing some optimism for future market conditions [11][25] - In China, CSL Behring's albumin portfolio saw exceptional performance, contributing to overall growth [16][95] Company Strategy and Development Direction - The company is focused on maintaining leadership in the iron market and expanding CSL Vifor's portfolio into new geographies [52][36] - CSL Behring is preparing for the global launch of ANDEMBRY and aims to complete the rollout of Rika technology across US plasma centers [50][51] - The company is confident in achieving its financial guidance for fiscal year 2025, expecting revenue growth of approximately 5 to 7% [52] Management's Comments on Operating Environment and Future Outlook - Management reaffirmed guidance for NPATA growth of 10% to 13% for fiscal year 2025, despite challenges in the Seqirus business [7][64] - The company anticipates increased revenue from avian flu vaccine contracts in the second half of the fiscal year [51][67] - Management expressed confidence in the long-term growth potential of the Ig franchise and the successful launch of new products [50][92] Other Important Information - The gross margin for CSL Behring improved by 170 basis points to 51.7% at constant currency [46] - General and administrative costs increased by 27% due to one-off project costs, expected to normalize in the second half [43][120] - The interim dividend was increased by 9% to US$1.30 per share [44] Q&A Session Summary Question: What is the expectation for Behring's gross margin in the second half? - Management indicated that while the first half showed strong performance, they expect the second half to be slightly lower, maintaining a full-year guidance of 100 basis points plus gross margin expansion [58][60] Question: How does Seqirus' performance impact overall guidance? - Management acknowledged Seqirus' weaker performance but noted that pandemic contracts in the second half would help offset this [64][67] Question: What are the drivers behind the strong growth in the Ig franchise? - Management attributed the growth to successful product launches and increased capacity, allowing them to meet patient needs effectively [70][71] Question: Can you provide details on the avian flu contracts? - Management confirmed that contracts have been signed and revenue will be recognized in the second half, but specific volumes were not disclosed [75][79] Question: What is the outlook for KCENTRA following the loss of a contract? - Management stated that KCENTRA remains a market leader despite the contract loss and expects growth moving forward [86][87] Question: How is HEMGENIX performing in the market? - Management expressed optimism about HEMGENIX, citing positive patient feedback and ongoing reimbursement efforts in Europe [90][92] Question: What is the impact of generic competition on FERINJECT? - Management acknowledged the presence of generic competition but emphasized their ability to grow volume and maintain market leadership [134][135]

Core Insights - CSL Limited and uniQure Inc announced the four-year results from the pivotal HOPE-B study, confirming the long-term durability and safety of Hemgenix for adults with hemophilia B [1][2] Group 1: Study Results - Hemgenix demonstrated sustained factor IX activity levels over four years, providing long-term bleed protection compared to prophylactic treatment [2][4] - The mean factor IX levels were recorded at 41.5 IU/dL in year one, 36.7 IU/dL in year two, 38.6 IU/dL in year three, and 37.4 IU/dL in year four [4] - The adjusted annualized bleeding rate (ABR) for all bleeds decreased by approximately 90% from lead-in to year four, with joint bleeds reducing from a mean ABR of 2.34 to 0.09 [5] Group 2: Patient Outcomes - In year four, 94% of patients remained free of continuous prophylaxis treatment, and no patients returned to continuous prophylaxis between year three and year four [5] - There were no serious adverse events related to the treatment throughout the study [5] Group 3: Product Information - Hemgenix, approved by the FDA in 2022, is the first gene therapy for adults with hemophilia B, applicable to patients with or without AAV5-neutralizing antibodies [3]

Core Insights - CSL announced the four-year results from the pivotal HOPE-B study, confirming the long-term durability and safety of HEMGENIX for adults with hemophilia B [1][4] - HEMGENIX is the first gene therapy approved for hemophilia B, providing significant long-term bleed protection and reducing the need for routine factor IX prophylaxis [1][11] Study Results - The HOPE-B trial involved 54 adult male participants, with 51 completing four years of follow-up [2][8] - Mean factor IX levels were sustained at 37.4 IU/dL at year four, with a 90% reduction in the adjusted annualized bleeding rate (ABR) from 4.16 (lead-in) to 0.40 [2][5] - Joint bleeds decreased from a mean ABR of 2.34 at lead-in to 0.09 during year four, with 94% of patients remaining free of continuous prophylaxis [2][5] Safety Profile - No serious adverse events related to HEMGENIX were reported, and it was generally well-tolerated [3][9] - The most common treatment-related adverse events were increases in alanine transaminase (ALT), with 16.7% of participants requiring supportive care [3][16] Company Commitment - CSL is dedicated to ongoing data analyses of HEMGENIX to provide healthcare providers and patients with necessary information for informed treatment decisions [4][20] - The company has established a post-marketing registry to gather additional evidence on the long-term safety and efficacy of HEMGENIX [4][20]