Notizie in diretta • 15h
CSL Faces A$7 Billion Write-Down as FY26 Outlook Softens and New Therapies Roll Out CSL announced an A$7 billion non-cash impairment, largely tied to the Vifor kidney treatment business and other assets. It cut its FY26 revenue and net profit forecasts to about A$15.2 billion and A$3.1 billion respectively after a 90-day review.
Management highlighted weaker demand for US immunoglobulin, softer albumin pricing in China, competition in iron therapies and geopolitical uncertainty in the Middle East as key operational challenges.
CSL Canada reported that the first Canadian patient has received HEMGENIX, its one-time gene therapy for hemophilia B, with public reimbursement now in place in Ontario and British Columbia and other provinces assessing coverage.
The combination of a large write-down, reduced FY26 guidance and clear headwinds in core markets indicates a longer, more complex turnaround, while CSL continues to progress new therapies like HEMGENIX that may broaden its treatment portfolio.
Investors can consider the risks from pressure on existing product lines and the size of the impairment alongside the potential long-term contribution of gene therapies and other growth initiatives, noting that the timing and scale of any benefits remain uncertain. Major Estimate Revision • May 12
Consensus EPS estimates have been downgraded. The consensus outlook for earnings per share (EPS) in fiscal year 2026 has deteriorated. 2026 revenue forecast decreased from US$15.8b to US$15.4b. Now expected to report a loss of US$0.44 per share instead of US$2.76 per share profit previously forecast. Biotechs industry in Australia expected to see average net income growth of 2.8% next year. Consensus price target down from AU$195 to AU$149. Share price fell 21% to AU$98.55 over the past week. Valuation Update With 7 Day Price Move • May 11
Investor sentiment deteriorates as stock falls 19% After last week's 19% share price decline to AU$101, the stock trades at a forward P/E ratio of 15x. Average trailing P/E is 28x in the Biotechs industry globally. Total loss to shareholders of 65% over the past three years. Upcoming Dividend • Mar 03
Upcoming dividend of US$1.30 per share Eligible shareholders must have bought the stock before 10 March 2026. Payment date: 09 April 2026. The company is paying out more than 100% of its profits but is generating plenty of cash to support the dividend. Trailing yield: 2.8%. Lower than top quartile of Australian dividend payers (6.0%). Higher than average of industry peers (1.9%). Valuation Update With 7 Day Price Move • Feb 17
Investor sentiment deteriorates as stock falls 16% After last week's 16% share price decline to AU$152, the stock trades at a forward P/E ratio of 22x. Average trailing P/E is 28x in the Biotechs industry globally. Total loss to shareholders of 47% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at AU$293 per share. Declared Dividend • Feb 16
First half dividend of US$1.30 announced Shareholders will receive a dividend of US$1.30. Ex-date: 10th March 2026 Payment date: 9th April 2026 Dividend yield will be 2.5%, which is lower than the industry average of 2.8%. Sustainability & Growth Dividend is not covered by earnings (101% earnings payout ratio). However, it is covered by cash flows (57% cash payout ratio). The dividend has increased by an average of 8.9% per year over the past 10 years and has been stable with no material reductions to payments, indicating a long track record of dividend growth and stability. The company's earnings per share (EPS) would need to grow by 12% to bring the payout ratio under control. EPS is expected to grow by 115% over the next 3 years, which is sufficient to bring the dividend into a sustainable range. Reported Earnings • Feb 14
First half 2026 earnings released: EPS: US$0.83 (vs US$4.15 in 1H 2025) First half 2026 results: EPS: US$0.83 (down from US$4.15 in 1H 2025). Revenue: US$8.33b (down 1.8% from 1H 2025). Net income: US$401.0m (down 80% from 1H 2025). Profit margin: 4.8% (down from 24% in 1H 2025). Revenue is forecast to grow 4.9% p.a. on average during the next 3 years, compared to a 7.5% growth forecast for the Biotechs industry in Australia. Over the last 3 years on average, earnings per share has increased by 1% per year but the company’s share price has fallen by 20% per year, which means it is significantly lagging earnings. Annuncio • Feb 11
CSL Limited Estimates Ordinary Dividend for the Six Months Period Ended December 31, 2025, Payable on April 9, 2026 CSL Limited estimated the ordinary dividend of USD 1.30000000 per share for the six months period ended December 31, 2025, payable on April 9, 2026. Ex date is on March 10, 2026 with Record date is on March 11, 2026. New Risk • Feb 11
New minor risk - Financial position The company has a high level of debt. Net debt to equity ratio: 49% This is considered a minor risk. Having a high level of debt increases the company's balance sheet risk. The company has a higher interest repayment burden, leading to the need to allocate a greater amount of its earnings towards servicing the debt, potentially limiting growth options or shareholder distributions. It can also increase the risk of bankruptcy if business conditions deteriorate enough that the company can no longer meet its debt obligations. Currently, the following risks have been identified for the company: Minor Risks High level of debt (49% net debt to equity). Dividend is not well covered by earnings (101% payout ratio). Large one-off items impacting financial results. Profit margins are more than 30% lower than last year (9.1% net profit margin). Annuncio • Dec 09
CSL Announces Five-Year (60-Month) Results from the Pivotal Phase 3 Hope-B Study CSL announced five-year (60-month) results from the pivotal Phase 3 HOPE-B study, confirming the long-term Durability and safety of a one-time infusion of HEMGENIX®? (etranacogene dezaparvovec-drlb) in adults living with hemophilia B. Published in the New England Journal of Medicine (NEJM) and presented simultaneously at the American Society of Hematology (ASH) Annual Meeting, the data reaffirm HEMGENIX's consistent performance over time to deliver durable factor IX activity levels, sustained bleed protection compared to prophylaxis treatment, and continued freedom from routine prophylaxis. HEMGENIX remains the only commercially available gene therapy for adults with hemophilia B and can be used in patients with or without AAV5 neutralizing antibodies. In the Phase 3, open-label, single-dose, single-arm HOPE-B trial, 54 adult male participants with severe or moderately severe hemophilia B, with or without preexisting AAV5 neutralizing antibodies, were infused with a single dose of HEMGENIX. Of the 54 participants, 50 completed five years of follow-up. The five-year follow-up analysis demonstrated: Durable Factor IX Activity: Mean factor IX activity levels were sustained at greater than 36% during years one through five post-infusion: mean factor IX activity levels of 41.5 IU/dL (n=50) at year one, 36.7 IU/dL (n= 50) at year two, 38.6 IU/dL (n=48) at year three, 37.4 IU/dL (n=47) at year four, and 36.1 IU/dL (n= 48) at year five. Sustained Bleed Protection: The mean adjusted annualized bleeding rate (ABR) for all bleeds was reduced by approximately 90% from the lead-in (4.16, n=54) compared to year five (0.40, n=51) post-infusion. Additionally, joint bleeds were reduced by 93% from lead-in (mean ABR of 2.34 at lead-in to 0.16 at year five) and spontaneous bleeds were reduced by 94% (mean ABR of 1.52 during lead-in versus 0.09 during year five). Freedom from Prophylaxis: 94% of patients remained free of continuous prophylaxis treatment following their one-time gene therapy infusion. This rate has remained consistent over time, with only one participant resuming continuous factor IX prophylaxis at month 30 post-infusion. Favorable Safety Profile: No serious adverse events were related to treatment with HEMGENIX. HEMGENIX was generally well-tolerated, with a total of 100 treatment-related adverse events (TRAEs), most of which occurred in the first four months post-infusion. Only five TRAEs were reported between years four and five. The most common adverse events were reported between years four and 5. The most common adverse events was reported between years four and five". Board Change • Nov 01
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Independent Non- Executive Director Cameron Price was the last director to join the board, commencing their role in 2025. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Valuation Update With 7 Day Price Move • Oct 28
Investor sentiment deteriorates as stock falls 19% After last week's 19% share price decline to AU$178, the stock trades at a forward P/E ratio of 21x. Average trailing P/E is 31x in the Biotechs industry globally. Total loss to shareholders of 34% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at AU$311 per share. Annuncio • Sep 17
CSL Limited, Annual General Meeting, Oct 28, 2025 CSL Limited, Annual General Meeting, Oct 28, 2025. Location: racv city club, level 17, 501 bourke street, and, melbourne 3000 Australia Upcoming Dividend • Sep 04
Upcoming dividend of US$1.62 per share Eligible shareholders must have bought the stock before 09 September 2025. Payment date: 03 October 2025. Payout ratio is a comfortable 47% and this is well supported by cash flows. Trailing yield: 2.1%. Lower than top quartile of Australian dividend payers (5.6%). In line with average of industry peers (2.2%). Major Estimate Revision • Aug 25
Consensus EPS estimates fall by 22% The consensus outlook for earnings per share (EPS) in fiscal year 2026 has deteriorated. 2026 revenue forecast decreased from US$16.8b to US$16.2b. EPS estimate also fell from US$7.10 per share to US$5.50 per share. Net income forecast to shrink 11% next year vs 2.3% decline forecast for Biotechs industry in Australia. Consensus price target down from AU$315 to AU$288. Share price fell 20% to AU$217 over the past week. Valuation Update With 7 Day Price Move • Aug 25
Investor sentiment deteriorates as stock falls 20% After last week's 20% share price decline to AU$217, the stock trades at a forward P/E ratio of 26x. Average trailing P/E is 28x in the Biotechs industry globally. Total loss to shareholders of 24% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at AU$342 per share. Board Change • Aug 22
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Non-executive Director Brian Daniels was the last director to join the board, commencing their role in 2024. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Annuncio • Aug 21
CSL Limited Announces Unfranked Dividend for the Period of Six Months Ended June 30, 2025, Payable on October 03, 2025 CSL Limited announced unfranked dividend of USD 1.62000000 for the period of six months ended June 30, 2025. Record Date is September 10, 2025. Ex- date is September 09, 2025. Payment date is October 03, 2025. Declared Dividend • Aug 21
Final dividend of US$1.62 announced Shareholders will receive a dividend of US$1.62. Ex-date: 9th September 2025 Payment date: 3rd October 2025 Dividend yield will be 1.6%, which is lower than the industry average of 2.8%. Sustainability & Growth Dividend is covered by both earnings (47% earnings payout ratio) and cash flows (55% cash payout ratio). The dividend has increased by an average of 8.5% per year over the past 10 years and has been stable with no material reductions to payments, indicating a long track record of dividend growth and stability. EPS is expected to grow by 41% over the next 3 years, which should provide support to the dividend and adequate earnings cover. Annuncio • Aug 19
CSL Limited Provides Earnings Guidance for the Year 2026 CSL Limited provided earnings guidance for the year 2026. For the year, the company expects 2026 group revenue growth is anticipated to be approximately 4-5% over Financial Year 2025 at constant currency. "CSL's NPATA for FY26, excluding the non-recurring restructuring cost, is anticipated to be in the range of approximately $3.45 billion to $3.55 billion at constant currency, representing growth over FY25 of approximately 7-10%. Reported Earnings • Aug 19
Full year 2025 earnings released: EPS: US$6.20 (vs US$5.47 in FY 2024) Full year 2025 results: EPS: US$6.20 (up from US$5.47 in FY 2024). Revenue: US$15.6b (up 5.1% from FY 2024). Net income: US$3.00b (up 14% from FY 2024). Profit margin: 19% (up from 18% in FY 2024). The increase in margin was driven by higher revenue. Revenue is forecast to grow 6.9% p.a. on average during the next 3 years, compared to a 8.2% growth forecast for the Biotechs industry in Australia. Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has fallen by 8% per year, which means it is significantly lagging earnings. Annuncio • Aug 08
Health Canada Authorized CSL's Andembry (Garadacimab) as Once-Monthly Treatment for Hereditary Angioedema (Hae) CSL announced that Health Canada has granted a marketing authorization for ANDEMBRY (garadacimab) for routine prevention of attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ANDEMBRY is a monoclonal antibody designed to target activated FXII (FXIIa), a plasma protein at the top of the HAE cascade that plays a key role in attacks of swelling in people with HAE. ANDEMBRY reinforces CSL's decades-long commitment to advancing innovation for the HAE community and is authorized with a prefilled pen for subcutaneous self-injection. HAE is a rare, chronic, and potentially life-threatening genetic disorder characterized by recurrent and predictable attacks of angioedema. Attacks of HAE are often painful and can affect multiple sites of the body, including the abdomen, larynx, face, and extremities. ANDEMBRY inhibits the top of the HAE Cascade while other HAE therapies target downstream mediators. The Health Canada authorization is based on data from the pivotal placebo-controlled Phase 3 VANGUARD trial evaluating the efficacy and safety of ANDEMBRY. The pivotal study (The Lancet, April 2023) demonstrated that treatment with ANDEMBRY: Reduced HAE attacks by a median of more than 99% and a reduced least squares mean of 89.2%, compared to placebo. Led to 62% of ANDEMBRY-treated patients remaining attack-free throughout the treatment period. The most common adverse reactions in the pivotal trial were injection site erythema, injection site bruising, injection site pruritus, injection site urticaria, headache, and abdominal pain. A published interim analysis (Allergy, Oct 2024) of the ongoing open-label extension study (median ANDEMBRY exposure of 13.8 months) showed that ANDEMBRY has a favorable long-term safety profile and provides sustained reductions in HAE attacks. Annuncio • Jun 18
CSL Limited announces U.S. Food and Drug Administration Approves Csl's Andembry®? (Garadacimab-Gxii) Treatment Targeting Factor Xiia with Once-Monthly Dosing for All Patients from the Start CSL announced the U.S. Food and Drug Administration (FDA) approved ANDEMBRY®? (garadacimab-gxii), the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. By targeting factor XIIa, a plasma protein that plays a key role in attacks of swelling in people with HAE, ANDEMBRY inhibits the top of the HAE cascade to prevent HAE attacks. ANDEMBRY, the only treatment to offer once-monthly dosing from the start for all patients, is a subcutaneous self-injection delivered in 15 seconds or less via an autoinjector with a citrate-free formula. HAE is a rare, chronic, and potentially life-threatening genetic disorder characterized by recurrent and predictable attacks of angioedema. This regulatory approval for ANDEMBRY is another crucial step in building toward the global availability of ANDEMBRY, which was recently approved in Australia, the United Kingdon (UK), the European Union (EU), Japan, Switzerland, and United Arab Emirates. CSL Behring will launch ANDEMBRY commercially immediately, with availability before the end of June. Healthcare professionals and patients interested in learning more about ANDEMBRY or accessing the therapy are encouraged to utilize ANDEMBRY ConnectSM, designed to offer comprehensive support and assistance through various programs. Patients who have abdominal attacks of HAE can experience extreme pain, diarrhea, nausea, and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face or throat can result in airway closure, asphyxiation and, if left untreated, death. ANDEMBRY is a novel monoclonal antibody inhibiting factor XIIa (anti-FXIIa mAb) that has completed the Phase 3 pivotal study as a new type of once-monthly subcutaneous prophylactic treatment for attacks related to HAE, a form of bradykinin-mediated angioedema. ANDEMBRY is CSL's first homegrown recombinant monoclonal antibody to gain FDA approval. It was discovered and optimized by scientists at CSL's Bio21-based research site, with formulation and manufacturing for the clinical programs completed at the CSL Broadmeadows Biotech Manufacturing Facility. ANDEMBRY uniquely inhibits the plasma protein, FXIIa. FXII is the first protein activated in the HAE pathway, initiating the cascade of events leading to an HAE attack. What are the possible side effects of ANDEMBRY? The most common side effects of ANDEMBRy include: Redness, itchiness, and bruising (injection-site reactions) Stomach (dominal) pain; Runny or stuffy nose, sneezing, watery eyes (nasopharyngitis). Annuncio • May 23
CSL Vifor Announces England's Nice Recommends Filspari®? (Sparsentan) as A Treatment Option for IgA Nephropathy CSL Vifor announced that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that sparsentan can be used in the NHS in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0 g/day or more, or a urine protein-to-creatinine ratio of 0.75 g/g or more. NICE has provided guidance to ensure that only patients responding to treatment continue. The decision follows authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025. What this means in practice is that there is enough evidence to show that sparsentan provides benefits and value for money, so it can be used routinely if it is considered the most suitable treatment option in this population. Sparsentan must be funded in England within 90 days of final publication of this guidance which is expected to be 27 June 2025. Upcoming Dividend • Mar 03
Upcoming dividend of US$1.30 per share Eligible shareholders must have bought the stock before 10 March 2025. Payment date: 09 April 2025. Payout ratio is a comfortable 48% and this is well supported by cash flows. Trailing yield: 1.6%. Lower than top quartile of Australian dividend payers (6.2%). In line with average of industry peers (1.6%). Annuncio • Feb 15
CSL and Arcturus Therapeutics Announces Marketing Authorization Grant by European Commission Marketing Authorization for Kostaive (Arct-154), A Self-Amplifying Mrna Covid-19 Vaccine CSL and Arcturus Therapeutics announced that the European Commission has granted marketing authorization for KOSTAIVE (ARCT-154), a self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. KOSTAIVE is the first sa-mRNA COVID-19 vaccine to receive approval from the European Commission (EC). KOSTAIVE is currently marketed in Japan against COVID-19. The European Commission approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on December 12, 2024. CSL - including three businesses: CSL Behring, CSL Seqirus and CSL Vifor - provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Annuncio • Feb 14
European Commission Approves CSL's ANDEMBRY®? (Garadacimab) for the Prevention of Recurrent Attacks of Hereditary Angioedema (HAE) CSL announced that the European Commission (EC) has approved ANDEMBRY®? (garadacimab), the first and only once-monthly treatment targeting factor XIIa to prevent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. ANDEMBRY inhibits plasma protein factor XIIa, which initiates the cascade of events leading to angioedema at various sites of the body. ANDEMBRY reinforces CSL's decades-long commitment to delivering innovative treatment modalities to the HAE community and comes with a convenient patient-centric pre-filled pen (auto-injector) enabling subcutaneous self-injection. The approval of ANDEMBRY is based on the efficacy and safety data from the pivotal international Phase 3 VANGUARD trial and its open-label extension study. The detailed results of the VANGUARD trial were published in The Lancet in April 2023 and the primary results of the ongoing open-label extension study were published in Allergy (October 2024). ANDEMBRY (garadacimab) is a novel Factor XIIa-inhibitory monoclonal antibody (anti-FXIIa mAb) that has completed Phase 3 clinical development as a new type of once-monthly subcutaneous prophylactic treatment for attacks related to HAE, a form of bradykinin-mediated angioedema. ANDEMBRY is CSL's first homegrown recombinant monoclonal antibody to gain approval. It was discovered and optimized by scientists at CSL's Bio21-based research site, with formulation and manufacturing for the clinical programs completed at the CSL Broadmeadows Biotech Manufacturing Facility. ANDEMBRY uniquely inhibits the plasma protein, FXIIa. Interactions: Patients should inform their doctor if they are taking any other medicines, including any medicines, vitamins or supplements that buy without a prescription from pharmacy, supermarket or health food shop. Side effects: The most commonly observed side effects associated with ANDEMBRY in the phase 3 clinical trial were injection site reactions (2/39, 5.1%) including red reactions (2/39,5.1%) including red reactions. Declared Dividend • Feb 13
First half dividend of US$1.30 announced Shareholders will receive a dividend of US$1.30. Ex-date: 10th March 2025 Payment date: 9th April 2025 Dividend yield will be 1.4%, which is lower than the industry average of 2.8%. Sustainability & Growth Dividend is covered by both earnings (48% earnings payout ratio) and cash flows (69% cash payout ratio). The dividend has increased by an average of 8.2% per year over the past 10 years and has been stable with no material reductions to payments, indicating a long track record of dividend growth and stability. EPS is expected to grow by 44% over the next 3 years, which should provide support to the dividend and adequate earnings cover. Reported Earnings • Feb 12
First half 2025 earnings: EPS and revenues miss analyst expectations First half 2025 results: EPS: US$4.15 (up from US$3.94 in 1H 2024). Revenue: US$8.48b (up 5.3% from 1H 2024). Net income: US$2.01b (up 5.6% from 1H 2024). Profit margin: 24% (in line with 1H 2024). Revenue missed analyst estimates by 1.1%. Earnings per share (EPS) also missed analyst estimates by 4.4%. Revenue is forecast to grow 6.6% p.a. on average during the next 3 years, compared to a 9.1% growth forecast for the Biotechs industry in Australia. Over the last 3 years on average, earnings per share has increased by 6% per year but the company’s share price has fallen by 1% per year, which means it is significantly lagging earnings. Annuncio • Feb 08
CSL Behring's Gene Therapy HEMGENIX®? (etranacogene dezaparvovec-drlb) Four Years Post-Infusion Data Continue to Show Sustained Efficacy and Safety in Adults with Hemophilia B CSL announced the four-year results from the pivotal HOPE-B study confirming the long-term durability and safety of a one-time infusion of HEMGENIX®? (etranacogene dezaparvovec-drlb) for adults living with hemophilia B. In an oral presentation at the 18th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), data showed that through four years, HEMGENIX continues to deliver elevated and sustained factor IX activity levels, can offer long-term and greater bleed protection compared to prophylactic treatment, can eliminate the need for routine factor IX prophylaxis, and maintains a favorable safety profile. Approved in 2022 by the U.S. Food and Drug Administration (FDA), HEMGENIX is the first gene therapy for the treatment of adults with hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. It is also the only approved gene therapy for hemophilia B that can treat adult patients with and without AAV5 neutralizing antibodies thereby providing the potential for a greater number of eligible patients to be treated. The multi-year clinical development of HEMGENIX was led by uniQure and sponsorship of the clinical trials transitioned to CSL after it licensed global rights to commercialize the treatment. Additionally, CSL established a post-marketing registry, which will be informative to all stakeholders and will generate additional evidence on the long-term safety, efficacy, and durability of gene therapy. HEMGENIX has also been granted conditional marketing authorization by the European Commission (EC) for the European Union and European Economic Area, the UK's Medicines and Healthcare products Regulatory Agency (MHRA), as well as authorization by Health Canada, Switzerland'sSwissmedic and provisional approval by Australia'sTherapeutic Goods Administration (TGA). To determine eligibility to receive HEMGENIX, will be tested for Factor IX inhibitors. If this test result is positive, a retest will be performed 2 weeks later. If both tests are positive for Factor IX inhibitors, doctor will not administer HEMGENIX to the company. Treatment for elevated liver enzymes could include corticosteroids. Annuncio • Dec 14
CSL Receives Positive CHMP Opinion for Garadacimab in Hereditary Angioedema (HAE) CSL announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting a marketing authorization for garadacimab as a once-monthly prophylactic treatment for hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. Garadacimab is a monoclonal antibody that targets activated factor XII (factor XIIa), a plasma protein that plays a key role in attacks of swelling in people with HAE, thereby inhibiting the HAE cascade at the top to prevent HAE attacks. The final European Commission (EC) decision is expected in First Quarter 2025. Attacks of HAE are often painful and can spread to multiple sites of the body, including the abdomen, larynx, face, and extremities. Current HAE preventive therapies work at various downstream steps in the cascade, but none prevent the cascade at its start. The CHMP positive opinion is based on data from the pivotal placebo-controlled Phase 3 VANGUARD trial and its open-label extension study, both evaluating the efficacy and safety of garadacimab. The pivotal study met its primary endpoint and showed that garadacimab led to 62 percent of patients achieving attack-free status throughout the treatment period, reduced the median number of HAE attacks to zero and reduced the mean number of HAE attacks per month by 86.5% compared to placebo. Interim analysis of the ongoing open-label extension study (median garadacimab exposure 13.8 months) showed that garadacimab has a favorable long-term safety profile and provides sustained HAE attack reduction. The full results from VANGUARD were published in The Lancet (April 2023) and the primary results of the ongoing open-label extension study were published in Allergy (October 2024). If granted, the centralized marketing authorization of garadacimab would be valid in all EU member states. The final opinion was published in the CHMP meeting highlights on the EMA website. Recent Insider Transactions • Nov 07
MD, CEO & Executive Director recently sold AU$1.1m worth of stock On the 31st of October, Paul McKenzie sold around 4k shares on-market at roughly AU$287 per share. This transaction amounted to 15% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Paul's only on-market trade for the last 12 months. Annuncio • Oct 17
CSL Vifor and Travere Therapeutics Announces Swissmedic Approval of FILSPARI (Sparsentan) for the Treatment of IgA Nephropathy CSL Vifor and Travere Therapeutics, Inc. announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion =1.0 g/day (or urine protein-to-creatinine ratio =0.75 g/g). Swissmedic approval was supported by results from the pivotal phase-III PROTECT study of FILSPARI in IgAN and follows full marketing approval by the U.S. Food and Drug Administration in September 2024 and conditional marketing authorization by the European Medicines Agency in April 2024. Annuncio • Sep 14
Japan's Ministry of Health, Labor and Welfare Approves CSL and Arcturus Therapeutics Holdings Inc.'s Updated Self-Amplifying mRNA Covid-19 Vaccine for Protection Against JN.1 Strain CSL and Arcturus Therapeutics Holdings Inc. announced that Japan's Ministry of Health, Labor and Welfare (MHLWs) granted approval and authorization for their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE. The updated vaccine is targeted to protect against the JN.1 lineage of Omicron subvariants for adults 18 years of age and older. CSL's exclusive partner in Japan, Meiji Seika Pharma, will begin distributing the updated vaccine in time for the October COVID-19 vaccination campaign, marking the commercially available sa-mRNA COVID-19 vaccine for adults 18 and older. In May 2024, a Japanese health ministry panel recommended that COVID-19 vaccines be updated to target the JN.1 lineage of Omicron subvariants for the 2024/2025 national immunization program. This aligns with recent recommendations from the World Health Organization. The approval is based on clinical evidence supporting the safety and effectiveness of CSL and Arcturus Therapeutics’ sa-mRNA COVID-19 vaccine, including published data demonstrating superior immunogenicity to Omicron BA 4/5 compared to a conventional mRNA COVID-19 vaccine booster and follow-up data demonstrating duration of immunity lasting up to one year. Recent Insider Transactions Derivative • Sep 07
MD, CEO & Executive Director exercised options and sold AU$1.1m worth of stock On the 3rd of September, Paul McKenzie exercised options to acquire 4k shares at no cost and sold these for an average price of AU$304 per share. This trade did not impact their existing holding. For the year to June 2020, Paul's total compensation was 23% salary and 77% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since December 2023, Paul's direct individual holding has increased from 22.46k shares to 26.95k. Company insiders have collectively sold AU$1.1m more than they bought, via options and on-market transactions in the last 12 months. Upcoming Dividend • Sep 02
Upcoming dividend of US$1.45 per share Eligible shareholders must have bought the stock before 09 September 2024. Payment date: 02 October 2024. Payout ratio is a comfortable 48% and the cash payout ratio is 79%. Trailing yield: 1.3%. Lower than top quartile of Australian dividend payers (6.3%). Lower than average of industry peers (2.0%). Declared Dividend • Aug 15
Final dividend of US$1.45 announced Shareholders will receive a dividend of US$1.45. Ex-date: 9th September 2024 Payment date: 2nd October 2024 Dividend yield will be 1.1%, which is lower than the industry average of 2.8%. Payout Ratios Payout ratio: 48%. Cash payout ratio: 85%. Reported Earnings • Aug 13
Full year 2024 earnings: EPS misses analyst expectations Full year 2024 results: EPS: US$5.47 (up from US$4.55 in FY 2023). Revenue: US$14.8b (up 11% from FY 2023). Net income: US$2.64b (up 20% from FY 2023). Profit margin: 18% (up from 17% in FY 2023). The increase in margin was driven by higher revenue. Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 3.2%. Revenue is forecast to grow 6.7% p.a. on average during the next 3 years, compared to a 8.1% growth forecast for the Biotechs industry in Australia. Over the last 3 years on average, earnings per share has increased by 1% per year whereas the company’s share price has remained flat. Annuncio • May 23
Nature Communications Publishes Pivotal Data Demonstrating Efficacy and Tolerability of CSL and Arcturus Therapeutics' COVID-19 Vaccine CSL and Arcturus Therapeutics announced Nature Communications has published results from an integrated phase 1/2/3a/3b study evaluating the safety, immunogenicity, and efficacy of ARCT, 154, a novel self-amplifying (sa-mRNA) COVID-19 vaccine and the world's first approved sa-mRNA COVID-19 vaccine. The results demonstrate that two 5 mg doses of ARCT-154, sa-mRNA vaccine, were well-tolerated, immunogenic and provided significant protection against multiple strains of COVID-19. The efficacy of ARCT-154 against severe COVID-19 was 100% in healthy persons aged 18-59 and more than 90% in persons at risk of severe consequences of the disease due to co-morbidities or older age. During the observer-blind, randomized, controlled phase 1, 2, 3a and 3b integrated study, adults =18 years old receive two 5 µg doses of ARCT-154 or saline placebo 28 days apart. Phase 2/3a/3b participants were stratified by age (< 60 or = 60 years of age) and by risk of severe COVID-19 prior to being randomized 3:1 (phase 1/2/3a) or 1:1 (phase 3b) to vaccine or placebo groups. The primary endpoints were vaccine efficacy up to 2 months after dose 2, reactogenicity within up to 7 days of each dose, safety within up to 28 days after each dose, and immunogenicity measured 28 days after each dose From August 15 to January 12, 2023, 1,001 participants were randomized (748 ARCT-154 and 253 placebo) in the integrated phase 1/2/3a study, and 16,100 participants (8,056 ARCT-154 and 8,044 placebo) in the phase 3b study. In the phase 1/2/3a studies, ARCT-154 was safe and well tolerated. Most solicited adverse events were mild or moderate and resolved quickly, and rates of related or severe unsolicited adverse events were similar in the ARCT-154 and placebo groups. The phase 3b study confirmed these observations. Four weeks after the second ARCT-154 dose in phase 3b, the neutralizing antibody seroconversion rate was 94.1% (95% CI: 92•1–95•8). There were 640 confirmed, protocol-defined COVID-19 cases, mainly of the Delta variant, that were determined to be eligible for analysis, including 43 severe cases and 10 deaths attributed to COVID-19. ARCT-154 absolute efficacy was 56.6% (95% CI: 48.7– 63.3) against any COVID-19, 95•3% (80.5–98.9) against severe COVID-19 and 86.5% (-7.4–98.3) against death due to COVID-19. Efficacy against severe COVID-19 was 100% in healthy 18-59-year-olds and 91.9% (37.9-98.9) in participants in that age group with underlying co-morbidities, which put them at risk for severe disease. In adults aged 60 years or older, efficacy was 54.3% (28.2–70.9) against COVID-19 of any severity and 94.4% (58.2–99.3) against severe COVID-19. Buy Or Sell Opportunity • Apr 27
Now 21% undervalued after recent price drop Over the last 90 days, the stock has fallen 6.7% to AU$273. The fair value is estimated to be AU$347, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 12% over the last 3 years. Earnings per share has declined by 6.4%. For the next 3 years, revenue is forecast to grow by 7.3% per annum. Earnings are also forecast to grow by 15% per annum over the same time period. Annuncio • Apr 24
CSL Vifor and Travere Therapeutics Announces European Commission Approves FILSPARI® (sparsentan) for the Treatment of IgA Nephropathy CSL Vifor and Travere Therapeutics, Inc. announced that the European Commission has granted conditional marketing authorization (CMA) for FILSPARI (sparsentan) for the treatment of adults with primary IgAN with a urine protein excretion =1.0 g/day (or urine protein-to-creatinine ratio =0.75 g/g). The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway. The European Commission's decision follows the Committee for Medicinal Products for Human Use (CHMP)'s positive opinion in February 2024, based on results from the pivotal phase-III PROTECT study of FILSPARI in IgAN. The PROTECT study met its primary endpoint at the pre-specified interim analysis with statistical significance. After 36 weeks of treatment, patients receiving FILSPARI achieved a mean reduction in proteinuria from baseline of 49.8 percent, compared to a mean reduction in proteinuria from baseline of 15.1 percent for irbesartan-treated patients. The two-year confirmatory results from the study showed treatment with FILSPARI achieved statistical significance on the eGFR chronic slope endpoint versus irbesartan and demonstrated clinically meaningful kidney function preservation. Buy Or Sell Opportunity • Mar 11
Now 20% undervalued Over the last 90 days, the stock has risen 4.3% to AU$281. The fair value is estimated to be AU$352, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 12% over the last 3 years. Earnings per share has declined by 6.4%. For the next 3 years, revenue is forecast to grow by 7.3% per annum. Earnings are also forecast to grow by 15% per annum over the same time period. Annuncio • Mar 06
CSL Seqirus Confirms Full Preparation to Implement the Fda's Vaccines and Related Biological Products Advisory Committee CSL Seqirus confirmed it is fully prepared to deliver its influenza vaccine portfolio for the 2024/25 U.S. season, based on the trivalent strains recommended this week by the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC). During the meeting, the committee confirmed the viral strain selection of influenza vaccines for the Northern Hemisphere 2024/25 season, which aligns with the February 2024World Health Organization (WHO) annual recommendations and is unchanged from the Southern Hemisphere 2024 season. The VRBPAC's recommendation follows the October 2023 VRBPAC meeting, where the committee strongly supported the WHO's recommendation to expeditiously remove the B/Yamagata influenza virus strain from quadrivalent influenza vaccines and transition to trivalent influenza vaccines for the 2024/25 season. The recommendation was grounded in data from the WHO's global influenza response and surveillance system, which detected a decline in B/Yamagata circulation before the onset of the COVID-19 pandemic and no further circulation of B/Yamagata lineage viruses since March of 2020. The strain selection for the 2024/25 influenza season reflects the removal of B/YamagATA and it will not be included in the vaccines manufactured and delivered by CSL Seqirus. CSL Seqirus worked closely with the FDA during 2023 to align on a path forward and is fully prepared to transition its complete portfolio of seasonal influenza vaccines in the U.S. market from quadrivalent to trivalent formulations for the 2024/25 influenza year. CSL Seqirus completed its transition plan for the 2024/2025 season by December 2023 and regulatory and manufacturing teams are on track to convert the full U.S. portfolio. As a result of this effort, CSL Seqirus received FDA approval on March 4, 2024 for all of its U.S. trivalent influenza vaccines. Across the world, CSL Seqirus is collaborating with regulatory bodies and public health authorities on an appropriate transition timeline for each country that aims to ensure a smooth transition, increase vaccine confidence and improve immunization rates. The undetectable circulation of B/YamAGata is a testament to the critical role of widely implemented influenza immunization programs, amongst other contributing factors such as the inherent characteristics and epidemiology of the B/YamagATA virus and the unique environment created by the COVID-19 pand pandemic. Upcoming Dividend • Mar 04
Upcoming dividend of US$1.19 per share Eligible shareholders must have bought the stock before 11 March 2024. Payment date: 03 April 2024. Payout ratio is a comfortable 48% and the cash payout ratio is 98%. Trailing yield: 1.3%. Lower than top quartile of Australian dividend payers (6.3%). Lower than average of industry peers (2.7%). Declared Dividend • Feb 16
First half dividend of US$1.19 announced Shareholders will receive a dividend of US$1.19. Ex-date: 11th March 2024 Payment date: 3rd April 2024 Dividend yield will be 1.1%, which is lower than the industry average of 2.8%. Payout Ratios Payout ratio: 48%. Cash payout ratio: 98%. Reported Earnings • Feb 14
First half 2024 earnings: EPS misses analyst expectations First half 2024 results: EPS: US$3.94 (up from US$3.37 in 1H 2023). Revenue: US$8.05b (up 12% from 1H 2023). Net income: US$1.90b (up 17% from 1H 2023). Profit margin: 24% (in line with 1H 2023). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 8.0%. Revenue is forecast to grow 7.4% p.a. on average during the next 3 years, compared to a 8.4% growth forecast for the Biotechs industry in Australia. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has remained flat, which means it is well ahead of earnings. 
