Roche Holding AG

Roche Holding AG is a research healthcare company. It operates through the Roche Pharmaceuticals and Diagnostics segments. The Roche Pharmaceutical division comprises the business segments, such as Roche Pharmaceuticals and Chuga. The Diagnostic division consists of the following four business areas: centralized and point of care solutions, molecular diagnostics, tissue diagnostics and diabetes care. The company was founded by Fritz Hoffmann-La Roche on October 1, 1896 and is headquartered in Basel, Switzerland.

Basel, 23 August 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has been made aware of an inadvertent disclosure of the second interim analysis of the Phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq® (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC).

[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on Phase III Skyscraper-01 study in PD-L1-high metastatic non-small cell lung cancer

The cobas ® connection modules (CCM) sample conveyors system has been extended with newly developed elevator and overhead conveyor modules enabling more flexibility in lab design. CCM Vertical optimises the use of laboratory space without compromising on sample throughput of CCM up to 2,500 samples per hour.

Roche launches a new addition to the cobas® connection modules, the CCM Vertical, helping to improve laboratory efficiency

Ninety-four (94%) percent of global survey respondents working in healthcare agree that using data to drive healthcare creates new opportunities for patients and doctors to benefit from more personalised healthcare approaches. Yet 43% say disconnected or incompatible systems and data remain one of the greatest inhibitors to their organisation's ability to become more data-driven.

New opportunities and persistent challenges revealed as organisations attempt more data-driven approaches to healthcare, says new report from Harvard Business Review Analytic Services

Expanded alliance includes an agreement on eco social collaboration to jointly foster more sustainable diagnostic solutions, and the renewal of an agreement on hematology solutions for commercial and hospital laboratories, complementing the Roche Diagnostics portfolio 25-year partnership between Roche and Sysmex brings hematology testing innovations to laboratories and helps patients get access to routine hematology diagnostics solutions BASEL, Switzerland , Aug. 3, 2023 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the expansion of their Global Business Partnership Agreement with Sysmex. As part of the renewed framework, the companies strengthen their commitment to their long-standing partnership.

Roche expands long-term alliance with Sysmex

Roche Holding AG (OTCQX:RHHBY) Q2 2023 Earnings Conference Call July 27, 2023 8:00 AM ET Company Participants Bruno Eschli - Head, Investor Relations Thomas Schinecker - Chief Executive Officer, Roche Group Teresa Graham - Chief Executive Officer, Roche Pharmaceuticals Matthew Sause - Chief Executive Officer, Roche Diagnostics Alan Hippe - Chief Financial and Information Officer Conference Call Participants Sachin Jain - Bank of America Matthew Weston - Credit Suisse Mark Purcell - Morgan Stanley Michael Leuchten - UBS Richard Vosser - JPMorgan Richard Parkes - BNP Paribas Peter Welford - Jefferies Simon Baker - Redburn Andrew Baum - Citi Emily Field - Barclays Luisa Hector - Berenberg Holger Blum - Patinex Management Rajesh Kumar - HSBC Operator Ladies and gentlemen, welcome to Roche's Half Year Results Webinar 2023. My name is Henrik and I'm the technical operator for today's call.

Roche Holding AG (RHHBY) Q2 2023 Earnings Call Transcript

Roche's (RHHBY) performance in the first half of 2023 was ordinary as COVID-19-test sales continue to decline and dent the top line.

Roche (RHHBY) 1H Revenues, Earnings Down on Lower COVID-19 Test Sales

Roche said it had abandoned certain drug development projects or acquisitions under consideration because of planned price cuts in best-selling prescription medicines in the United States.

Roche: have abandoned some trials due to U.S. drug pricing plans

Roche said first-half core operating profit fell 14% as the Swiss drugs and diagnostics maker was hit by a sharp decline in sales of COVID-19 products but the strong launch of a new eye drug mitigated the decline.

Eye drug success mitigates Roche's earnings decline

Basel, 27 July 2023 Excluding COVID-19 products, Group sales increase strongly by 8%1 at constant exchange rates (CER) In line with the expected declining demand for COVID-19 products, Group sales decrease 2% (-8% in Swiss francs) Pharmaceuticals Division sales grow strongly by 8% due to continued high demand for newer medicines; new eye medicine Vabysmo is the strongest growth driver Diagnostics Division's base business continues its good growth momentum with an increase of 6%, while total divisional sales are 23% lower due to exceptionally high demand for COVID-19 tests in the first half of 2022 Core earnings per share decrease 5%, driven by lower demand for COVID-19 products and a base effect from a patent settlement in 2022; IFRS net income down 9% due to lower core operating profit and higher interest expenses Highlights in the second quarter of 2023: US and EU approvals of Columvi (aggressive form of blood cancer) US approval of Elevidys for Roche partner Sarepta (first gene therapy for children with Duchenne muscular dystrophy) Positive phase III data for subcutaneous injection of Ocrevus (multiple sclerosis); positive long-term efficacy and safety data for Evrysdi (spinal muscular atrophy) and positive phase II data for fenebrutinib (multiple sclerosis) Start of phase III study of tiragolumab in combination with Tecentriq and Avastin (liver cancer) Partnership with Alnylam to co-develop phase II RNAi therapeutic zilebesiran (hypertension in patients with high cardiovascular risk) WHO prequalification of cobas HPV test enables improved access to cervical cancer screening in low and lower-middle income countries Outlook for 2023 confirmed Roche CEO Thomas Schinecker: “In the first half of 2023, sales in the base business of both our divisions grew strongly, largely offsetting the impact of declining demand for COVID-19 products. Vabysmo continues its strong momentum – now providing treatment for patients with severe eye conditions in over 70 countries.

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong growth in both divisions' base business; Group sales and profit reflect declining demand for COVID-19 products

Roche's (RHHBY) Evrysdi gets a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for extended use in infants under two months with spinal muscular atrophy.

Roche (RHHBY) SMA Drug Gets Positive CHMP Opinion for Expanded Use

Alnylam Pharmaceuticals

Swiss pharmaceutical group Roche said on Monday it had entered into a partnership with U.S. biopharmaceutical company Alnylam to co-develop and co-commercialise zilebesiran, a therapy to treat hypertension in patients with high cardiovascular risk.

Roche enters partnership with Alnylam for hypertension therapy

Basel, 24 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today a new partnership with Alnylam to develop and commercialise zilebesiran, an investigational RNAi therapeutic currently in Phase 2 for the treatment of hypertension. Hypertension affects more than 1.2 billion adults worldwide and is the main, independent, preventable risk factor for death and disability, with approximately 80% of the adults with hypertension worldwide not being able to effectively manage their blood pressure.1

Roche enters partnership with Alnylam to co-develop and co-commercialise RNAi therapeutic zilebesiran to treat hypertension in patients with high cardiovascular risk

Basel, 21 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the Evrysdi® (risdiplam) European Union (EU) marketing authorisation, which would include infants with genetically confirmed diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies, including from birth to below two months.1 The recommendation is based on an interim analysis from the ongoing RAINBOWFISH trial in pre-symptomatic babies with Type 1 SMA from birth to six weeks. In SMA, early treatment is critical to counteract ongoing and irreversible loss of motor neurons.3 ,4,5 A final decision regarding the approval is expected from the European Commission later this year. “Treating babies with SMA early helps them to carry out daily activities such as sitting, standing, and walking,” said Levi Garraway, M.D., Ph. D., Chief Medical Officer and Head of Global Product Development. “This CHMP recommendation is an important step towards treating babies from birth with an oral formulation, and is a testament to Evrysdi's impact on preserving precious muscle function and improving the daily lives of people with SMA.” The CHMP decision is based on the RAINBOWFISH interim analysis (n=18), which included 6 babies with 2 or 3 copies of the SMN2 gene who completed at least one year of study assessments. Of these, 100% (6/6) were able to sit after one year of treatment with Evrysdi, 67% (4/6) could stand and 50% (3/6) could walk independently. All infants were alive at 12 months without permanent ventilation.   The RAINBOWFISH data show that the safety profile of Evrysdi in pre-symptomatic babies is consistent with the safety profile seen in previous trials with symptomatic SMA patients. The most common adverse reactions were fever, diarrhoea, rash, upper respiratory tract infection (including nasopharyngitis, rhinitis), lower respiratory tract infection (including pneumonia, bronchitis), constipation, vomiting and cough. Evrysdi is currently approved in the EU for the treatment of patients aged two months or older.6 Roche is currently investigating Evrysdi in combination with an anti-myostatin molecule targeting muscle growth in the Ph II/III trial MANATEE for the treatment of SMA. About Evrysdi ® ( risdiplam ) Evrysdi is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube.

CHMP recommends Roche's Evrysdi for babies under two months old with spinal muscular atrophy (SMA)

Basel, 20 July - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that data from its ophthalmology portfolio will be highlighted in 25 abstracts at the 2023 American Society of Retina Specialists (ASRS) Annual Meeting, which will be held from 28 July to 1 August in Seattle, United States. The data further advance the depth of clinical and real-world evidence supporting the use of Vabysmo® (faricimab), the first and only bispecific antibody for the eye, for the treatment of neovascular or ‘wet' age-related macular degeneration (nAMD) and diabetic macular edema (DME).1-14

New clinical and real-world data for Roche's Vabysmo at ASRS reveal improved outcomes for people with two leading causes of vision loss

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that data from its ophthalmology portfolio will be highlighted in 25 abstracts at the 2023 American Society of Retina Specialists (ASRS) Annual Meeting, which will be held from July 28 to August 1 in Seattle, WA. The data further advance the depth of clinical and real-world evidence supporting the use of Vabysmo® (faricimab-svoa), the first and only bispecific antib.

New Clinical and Real-World Data for Genentech's Vabysmo at ASRS Reveal Improved Outcomes for People With Two Leading Causes of Vision Loss

Roche will unveil the next generation of core lab and molecular systems and cobas® connection modules. Attendees can experience an integrated lab that goes beyond simply connecting individual technologies, demonstrating true end-to-end operational excellence.

Roche to showcase next-generation diagnostic solutions at the American Association of Clinical Chemistry 2023 Clinical Lab Expo

Roivant Sciences Ltd

Roche is in discussions to buy a stomach-disease treatment from Roivant for around $7 billion. The report sent ROIV stock surging Friday.

Roivant Surges As Roche Reportedly Considers $7 Billion Drug Takeover

Biotech company Roivant Sciences is nearing a deal to sell an experimental drug to treat inflammatory bowel diseases including ulcerative colitis and Crohn's disease to Roche in a deal that could be valued at more than $7 billion, the Wall Street Journal reported on Thursday.

Roivant in talks to sell bowel disease drug to Roche in over $7 bln deal - WSJ

Roivant, started by presidential candidate Vivek Ramaswamy, could seal a deal in coming days

Roivant in Talks to Sell Stomach Drug to Roche in Deal Valued at More Than $7 Billion

TG Therapeutics

Roche unveiled positive results Thursday for a rival to TG Therapeutics' infusion for multiple sclerosis patients, and TGTX stock crashed.

How Roche Just Cut Top 1% Biotech Stock TG Therapeutics Down A Peg

LEXINGTON, Mass.--(BUSINESS WIRE)--KSQ Therapeutics, Inc. (“KSQ”), a clinical-stage biotechnology company developing cancer therapies using its proprietary CRISPRomics® discovery platform, announced today it has entered into a worldwide license and collaboration agreement with Roche for the development and commercialization of KSQ-4279. KSQ-4279 is a first-in-class, potent, and selective small molecule inhibitor of USP1, a protein that regulates DNA damage response (DDR) in a manner distinct fr.

KSQ Therapeutics Enters Worldwide License Agreement with Roche for KSQ-4279, a Clinical-Stage USP1 Inhibitor for Cancer

Basel, 13 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III OCARINA II trial evaluating OCREVUS® (ocrelizumab) as a twice a year 10-minute subcutaneous injection met its primary and secondary endpoints in patients with relapsing forms of MS or primary progressive MS (RMS or PPMS). OCREVUS subcutaneous injection was shown to be non-inferior to OCREVUS given by intravenous infusion (IV), as measured by pharmacokinetics (levels in the blood) over 12 weeks. OCREVUS subcutaneous injection was also comparable with OCREVUS IV in controlling magnetic resonance imaging (MRI) lesion activity in the brain over 12 weeks. The safety profile of OCREVUS subcutaneous injection was consistent with that of OCREVUS IV.

Positive Phase III results for Roche's OCREVUS (ocrelizumab) twice a year, 10-minute subcutaneous injection in patients with multiple sclerosis

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the Phase III OCARINA II trial evaluating Ocrevus® (ocrelizumab) as a twice a year 10-minute subcutaneous injection met its primary and secondary endpoints in patients with relapsing forms of MS or primary progressive MS (RMS or PPMS). Ocrevus subcutaneous injection was shown to be non-inferior to Ocrevus given by intravenous infusion (IV), as measured by pharm.

Positive Phase III Results for Genentech's Ocrevus (ocrelizumab) Twice a Year, 10-Minute Subcutaneous Injection in Patients With Multiple Sclerosis

Roche's (RHHBY) blood cancer portfolio gets a boost with the EC's approval of Columvi (glofitamab-gxbm) for treating patients with R/R DLBCL.

Roche (RHHBY) Blood Cancer Drug Columvi Wins EC Approval

Basel, 11 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has granted conditional marketing authorisation for Columvi® (glofitamab) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. With this approval, Columvi is the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with the most common and aggressive form of lymphoma following multiple lines of therapy. Columvi has the potential to change the current standard of care in DLBCL. As well as inducing early and long-lasting responses in people with heavily pre-treated or refractory DLBCL, Columvi is designed to be given for a fixed period of time meaning that people have a target end date for their course of treatment and the possibility of a treatment-free period. It is also a chemotherapy-free treatment option that is off-the-shelf, meaning that people do not have to wait for cell collection and genetic engineering - a multistep process that can take several weeks - before starting treatment. This could be particularly important for patients who are at a high-risk of their disease progressing.

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