ItovebiTM (inavolisib)-based regimen demonstrated a statistically significant and clinically meaningful benefit, reducing the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in the INAVO120 study1 The U.S. FDA recently approved the Itovebi-based regimen as a first-line treatment for people with HR-positive, HER2-negative breast cancer with a PIK3CA mutation, one of the most commonly mutated genes in HR-positive disease2 Basel, 31 October 2024 - Roche (SIX: RO, ROG; ...

Financial Data and Key Metrics - Year-to-date group sales grew by 6% at constant exchange rates, driven by strong base business growth of 8% [3] - COVID-19 sales decreased by approximately CHF 800 million, and the loss of exclusivity (LOE) impact was also around CHF 800 million, both in line with guidance [3] - Full-year COVID-19 sales decline is expected to be CHF 1.1 billion, with a CHF 300 million impact in Q4 due to a rapid antigen order from the previous year [7][12] - Core EPS growth guidance was raised, with group sales expected to grow in the mid-single-digit range [12] Business Line Performance - Pharma division grew by 9%, while Diagnostics grew by 8% in the base business [3] - Oncology sales increased by 2% to CHF 11.9 billion, driven by strong performance in HER2 franchise and Tecentriq [22][23] - Hematology sales grew by 12% to CHF 5.8 billion, with Hemlibra achieving a 42% market share [28] - Neurology franchise grew by 14%, reaching CHF 7 billion in sales, driven by Ocrevus and Elevidys [31][33] - Immunology sales increased by 1% to CHF 4.6 billion, with Xolair growing by 12% [36][37] - Ophthalmology franchise grew by 47%, reaching CHF 3 billion in sales, led by Vabysmo [38] Market Performance - North America base business grew by 10%, EMEA by 6%, and APAC by 5%, excluding COVID-19 sales [50] - China experienced a slowdown due to macroeconomic conditions, but the company remains the market leader [50] - The US market saw strong growth in Vabysmo, with market shares increasing in AMD, DME, and RVO [38] Strategic Direction and Industry Competition - The company expects to launch two new NMEs (PiaSky and Itovebi) in 2024, with the new and young portfolio now making up 56% of Pharma sales [9][10] - Key growth opportunities include Itovebi EU approval, Evrysdi GYM329 readout, and anti-TL1A Phase 3 trials in UC and Crohn's disease [10][11] - The company completed the acquisition of LumiraDx, which is expected to contribute significantly to Diagnostics sales in the coming years [55] Management Commentary on Operating Environment and Future Outlook - The company expects strong base business growth to continue into Q4 and next year, with no significant COVID-19 impact expected in 2025 [7][12] - Management highlighted cost discipline and confidence in achieving core EPS growth, with plans to increase dividends in Swiss francs [12] - The company remains optimistic about its pipeline, with several key readouts and regulatory events expected in 2025 [45][46] Other Important Information - The company received five regulatory approvals in Q3, including Itovebi in the US and Vabysmo in the EU [4][5] - Key launches in Diagnostics include the cobas pro serology solution and the Respiratory flex test, which leverages TAGS technology [5][53] - The company expects to deliver 12 key launches in Diagnostics by the end of 2024, with nine already achieved by Q3 [55][56] Q&A Session Summary Question: Impact of Amgen's EYLEA biosimilar on Vabysmo - The company does not expect material impact on Vabysmo's growth trajectory, as the ophthalmology market has been about 50% generic biosimilar [58] Question: Tecentriq sales outlook - Tecentriq is expected to grow low single digits for the next year, with competitive pressure in adjuvant lung in the US [59] Question: Xolair biosimilar entry in 2025 - The company confirmed no biosimilar entry for Xolair in 2025, but did not provide specific reasons [63] Question: Elevidys sales and market traction - Elevidys sales reached CHF 137 million, with strong adoption in Gulf states and health tourism observed [65] Question: Fenebrutinib in MS - The company is pleased with the results so far and does not plan to change the primary endpoint [66] Question: TL1A opportunity in IBD - The TL1A pathway is well-validated in IBD, with a potential $10 billion market opportunity and significant unmet need [84][85] Question: Ocrevus subcutaneous formulation - The company expects the subcut formulation to expand Ocrevus use in settings where IV is not available, with an incremental CHF 2 billion sales opportunity [77] Question: Inavolisib physician feedback - Physicians are excited about inavolisib, and the company is working to generate additional data with other CDK4/6 backbones [90] Question: Prasinezumab and Lunsumio outlook - Prasinezumab is a high-risk, high-reward trial, and Lunsumio's real opportunity lies in moving beyond third-line follicular lymphoma [93][94]

Swiss pharma giant Roche Holding AG (RHHBY) posted strong growth in the third quarter. Sales increased 6% year over year to CHF 15.1 billion and were up 9% at constant exchange rates (CER).Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.The company reports under two divisions — Pharmaceuticals and Diagnostics. All growth rates mentioned below are on a year-over-year basis and at CER.Total sales increased 6% in the first nine months of 2024 to CHF 45 billion. Excluding COVID-19-relat ...

Group sales grew by 6%1 at constant exchange rates (CER) (2% in CHF) in the first nine months, driven by the high demand for both our medicines and diagnostics; excluding COVID-19-related products, sales increased by 8%In the third quarter, Group sales rose by 9% (6% in CHF), as they did in the second quarter Pharmaceuticals Division sales rose by 7% in the first nine months; the strong growth of 9% in the base business2 was driven by continued high demand for our newer medicines to treat severe diseases; V ...

Over the last couple of years, one of the biggest stories in the stock market has been around pharmaceutical companies that are thriving due to the proliferation of their weight loss drug treatments. The two firms that most readily come to mind are Eli Lilly NYSE: LLY and Novo Nordisk NYSE: NVO. These firm’s GLP-1 receptor agonist drugs have seen skyrocketing sales due to their unprecedented ability to help patients lose considerable amounts of body weight in a relatively short amount of time.This isn't sur ...

The new VENTANA CLDN18 (43-14A) RxDx Assay helps fulfil an unmet medical need by enabling clinicians to identify patients with gastric or gastroesophageal junction (GEJ) cancer who may benefit from a targeted treatment option. CLDN18.2 is an emerging biomarker in gastric and GEJ cancers and helps predict the likelihood of response to targeted therapy. As the leader in companion diagnostics, Roche continues to build on its commitment to improve personalised healthcare to enable better patient outcomes. TUCSO ...

VYLOY is the first and only CLDN18.2-targeted treatment approved in the U.S. for adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive TOKYO, Oct. 18, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY™ (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of ad ...

Roche (RHHBY) announced that the FDA has approved pipeline candidate, inavolisib, for the treatment of breast cancer, under the brand name Itovebi. The drug is approved in combination with Pfizer's Ibrance (palbociclib) and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDAapproved test, following recurrence on or after c ...

BRISBANE, Calif., Oct. 10, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced an agreement with Roche to advance the evaluation of amezalpat (TPST-1120) in combination with atezolizumab (Tecentriq®) and bevacizumab, the current standard of care for unresectable or metastatic hepatocellular carcinoma (HCC), into a pivotal Phase 3 trial for the first-lin ...

I publish my best ideas and top coverage on the Growth Stock Forum . If you're interested in finding great growth stocks, with a focus on biotech, consider signing up. We focus on attractive risk/reward situations and track each of our portfolio and watchlist stocks closely. To receive e-mail notifications for my public articles and blogs, please click the follow button . And to go deeper, sign up for a free trial to Growth Stock Forum. Shares of Roche Holding AG ( OTCQX:RHHBY ) pulled back this month after ...