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.

Following the label expansion, Roche's (RHHBY) Evrysdi is now approved to treat people of all ages with SMA in the European Union.

Roche's (RHHBY) Evrysdi Gets Label Expansion in EU for Newborns

Basel, 29 August 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Tecentriq® SC (atezolizumab) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. It will be provided by the National Health Service (NHS) England. Injecting Tecentriq subcutaneously (under the skin) takes approximately seven minutes, compared with 30-60 minutes for intravenous (IV) infusion. Tecentriq SC will be available to patients in Great Britain for all indications in which the IV formulation of Tecentriq has been previously approved, including certain types of lung, bladder, breast and liver cancer.2

Roche's Tecentriq becomes the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain, reducing treatment time to just minutes

Basel, 29 August 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved the extension of the Evrysdi® (risdiplam) European Union (EU) marketing authorisation to include infants with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies from birth to below two months.1 Interim data from the ongoing RAINBOWFISH trial in pre-symptomatic babies from birth to six weeks with Type 1 SMA supported the marketing authorisation extension.

European Commission approves Roche's Evrysdi for babies under two months old with spinal muscular atrophy (SMA)

Shares of several companies developing anti-TIGIT therapies rise after Roche (RHHBY) accidentally leaks encouraging late-stage study data.

Biotech Stocks Rally After Roche's (RHHBY) Accidental Data Leak

Roche's (RHHBY) stock jumps 4.3% on Wednesday after the company inadvertently publishes encouraging second interim analysis data from its combination drug study to treat cancer.

Roche (RHHBY) Up on Upbeat Data From Combo Drug Cancer Study

Gilead Sciences

Merck

Cancer drug stocks were boosted on Wednesday after Roche accidentally published positive interim results from its lung cancer treatment study. The Swiss drugmaker said that it had been made aware of the inadvertent disclosure of the second interim analysis from its Phase 3 study evaluating its investigational anti-TIGIT (T cell immunoreceptor with immunoglobulin and ITIM domains) immunotherapy tiragolumab in combination with the established immune-oncology drug Tecentriq for people with lung cancer.

Cancer drug stocks soar after Roche accidentally releases positive interim lung cancer trial results

iTeos Therapeutics, Inc.

Arcus Biosciences

Roche accidentally published positive interim results from a lung cancer treatment study, which boosted shares of rivals Iteos and Arcus.

How Roche's Accidental Cancer Update Lifted Iteos And Arcus More Than 30%

Shares of biopharmaceutical companies developing anti-TIGIT cancer therapies, including Gilead Sciences Inc. GILD, +0.54%, Arcus Biosciences Inc. RCUS, -0.84% and iTeos Therapeutics Inc. ITOS, +2.80%, got a boost premarket on Wednesday after Roche AG RHHBY, -1.10% said there had been an “inadvertent disclosure” of interim data from a study of its anti-TIGIT therapy tiragolumab in non-small cell lung cancer. The interim results showed positive data for overall survival with tiragolumab, but the results were “not mature” at the time of the analysis that was disclosed, Roche said in a release.

Gilead, Arcus, iTeos, other biopharmas get boost from accidental disclosure of Roche lung cancer trial data

Swiss drug maker Roche said on Wednesday it had been made aware of an inadvertent disclosure in a study of its new immunotherapy for patients with lung cancer using an experimental class of drugs known as anti-TIGIT.

Roche reports inadvertent disclosure in lung cancer immunotherapy study

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), 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). SKYSCRAPER-01.

Genentech Provides Update on Phase III SKYSCRAPER-01 Study in PD-L1-High Metastatic Non-Small Cell Lung Cancer

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.

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