Roche 2020: Built for innovation PharmaLive – PharmaLive

Roche is focused on finding new treatments and diagnostics that help patients live longer, better lives, and evolve the practice of medicine.

By Andrew Humphreys [emailprotected]

F. Hoffmann-La Roche ltd.

KonzernHauptsitz Grenzacherstrasse 124 CH-4070 Basel Switzerland Telephone: +41-61-688 1111 Website: roche.com

FINANCIAL PERFORMANCE

(All sales are in millions of dollars, except EPS, and were translated using the Federal Reserve Boards average rate of exchange in 2019: SFr 0.9937)

2019

Revenue $61,856

Net income $13,583

Diluted EPS $15.72

R&D expense $11,770

1H 2020

Revenue $29,467

Net income $8,519

Diluted EPS $9.38

R&D expense $5,824

BEST-SELLING Rx PRODUCTS

(All sales are in millions of dollars and were translated using the Federal Reserve Boards average rate of exchange in 2019: SFr 0.9937)

2019

Avastin $7,118

Rituxan/MabThera $6,518

Herceptin $6,077

Ocrevus $3,732

Perjeta $3,544

Actemra/RoActemra $2,326

Xolair $1,981

Tecentriq $1,887

Lucentis $1,838

Kadcyla $1,402

Hemlibra $1,389

Activase, TNKase $1,340

Esbriet $1,136

Alecensa $882

Pulmozyme $756

CellCept $660

Mircera $595

Gazyva/Gazyvaro $555

1H 2020

Avastin $2,853

Rituxan/MabThera $2,455

Herceptin $2,214

Ocrevus $2,089

Perjeta $1,953

Actemra/RoActemra $1,470

Tecentriq $1,305

Hemlibra $1,009

Xolair $964

Kadcyla $842

Lucentis $733

Activase, TNKase $695

Esbriet $570

Alecensa $543

Pulmozyme $354

CellCept $316

Gazyva/Gazyvaro $312

Mircera $253

Outcomes Creativity Index Score: 2 Manny Awards N/A Cannes Lions N/A LIA: Health & Wellness N/A Clio Health 1 One Show: HW&P N/A MM&M Awards 1 Global Awards N/A Creative Floor Awards N/A

Roche has a more than 120-year history of advancing the field of medicine and bringing novel treatments and diagnostics to patients. The patient is and will remain at the core of what we do, the reason we come to work every day, Roche executives say. Our autonomous research and development centers and alliances with more than 200 external partners foster a diversity of scientific approaches and agility. Our global geographical scale and reach enables us to attract talent in the leading global science clusters and to bring our diagnostics and medicines quickly to people who need them.

The corona pandemic continues to pose an enormous challenge worldwide. I am grateful that, in close collaboration with health authorities, we have been able to make a number of SARS-CoV-2 tests available and start several global Actemra/RoActemra phase III studies in COVID-19 pneumonia. At the same time, Roches regular business was significantly impacted by the pandemic in the second quarter. But we now see clear signs of recovery. Furthermore, the uptake of our recently introduced medicines and diagnostic tests continues to be strong. Based on our current assessment of the impact of the pandemic, we can confirm the outlook for the full year. CEO Severin Schwan

2020 Performance & Outlook

Group sales in first-half 2020 increased 1% to CHF 29.28 billion ($29.47 billion) and core EPS rose 2%, ahead of sales. IFRS net income grew 3% at constant exchange rates, due to the strong underlying core results. As a result of the continued appreciation of the Swiss franc against most currencies, the IFRS net income expressed in Swiss francs declined 5% to CHF 8.47 billion ($8.52 billion).

Sales in the Pharmaceuticals Division during the 2020 first half improved 1% to CHF 23.2 billion ($23.35 billion). Roche says the COVID-19 pandemic had an overall negative impact on the divisions sales, especially during May. Hospitalizations and out-patient visits were down, which particularly impacted sales of Ocrevus, Hemlibra, Lucentis and Rituxan/MabThera. Key growth drivers during first-half 2020 were the cancer medicine Tecentriq, the hemophilia drug Hemlibra, the multiple sclerosis product Ocrevus, Actemra/RoActemra in immunology and Perjeta in breast cancer. The new medicines (+37%) generated sales of CHF 8.9 billion ($8.96 billion) and increased by CHF 2.5 billion ($2.52 billion) at constant exchange rates over same-time 2019, more than offsetting the impact of the competition from biosimilars (CHF 2.1 billion at constant exchange rates).

U.S. sales fell 4% compared to the 2019 first half. While sales of Hemlibra, Ocrevus, Tecentriq and Actemra/RoActemra rose, competition from biosimilars for Herceptin, Avastin and Rituxan/MabThera impacted this growth as expected. Hemlibra sales advanced 80%, resulting from the ongoing U.S. rollouts. Sales for Ocrevus went up 19% and were driven by both new and returning patient demand. First-half 2020 sales of both Hemlibra and Ocrevus were partly impacted by COVID-19 effects. Tecentriq sales rose 52%, driven by growth in the new indications ES-SCLC and triple-negative breast cancer. In the United States and other countries, increased use of Actemra/RoActemra in patients with severe COVID-19 pneumonia can be observed as countries included it in their treatment guidelines, Roche says. Actemra/RoActemra is not currently approved for this use; Roche is conducting several phase III clinical trials in severe COVID-19 pneumonia.

Sales in Europe during the first six months of 2020 increased (+5%) as the strong demand for Tecentriq, Ocrevus, Hemlibra, Kadcyla, Perjeta and Actemra/RoActemra was able to offset the impact of lower sales of Herceptin (-33%) and Rituxan/MabThera (-34%). The first biosimilar versions of Avastin could come to market in Europe during second-half 2020.

In the International region (+11%), first-half 2020 growth was mostly driven by Russia and China. Growth in China resulted from a strong uptake of Perjeta and Alecensa, which was partially offset by the National Reimbursement Drug List price cut and COVID-19 impact for Herceptin, Rituxan/MabThera and Avastin.

Sales decreased in Japan 2% versus the January-June 2019 period, resulting from considerable competition from biosimilars, generics and government price cuts. This decrease was partially compensated by recently launched medicines including Tecentriq, Hemlibra and Perjeta.

Diagnostics Division sales for the January-June 2020 period grew 3% to CHF 6.08 billion ($6.12 billion). The Molecular Diagnostics business area (+61%) was the main growth contributor. Sales of the recently developed cobas SARS-CoV-2 PCR tests could offset the negative impact of the COVID-19 pandemic on products for routine diagnosis, management says. First-half growth was reported in North America (+13%), EMEA (+5%), Latin America (+6%) and Japan (+1%). In the Asia-Pacific region (-9%), decreased sales were strongly impacted by the COVID-19 pandemic shutdown in China. Overall, demand was impacted by COVID-19 in all regions in Q2 2020. Routine testing declined significantly due to a decrease in regular health checks while emergency and SARS-Co-V-2 testing rose significantly.

The core operating profit increased 2% in the Pharmaceuticals Division and 9% in the Diagnostics Division for the first six months of 2020.

Based on the current assessment of the COVID-19 impact, full-year 2020 sales are expected to grow in the low- to mid- single digit range, at constant exchange rates. Core earnings per share are targeted to increase broadly in line with sales, at constant exchange rates. Roche expects to increase the companys dividend in Swiss francs further.

COVID-19 Pandemic Response

Ever since the early phase of the COVID-19 pandemic, we have been partnering with healthcare providers, laboratories, authorities and organizations to provide patients with the tests, treatments and care they need, Roche management says. The portfolio of our recently developed SARS-Co-V-2 tests as well as our existing diagnostics menu for critical care have become a significant factor in supporting patient management during the COVID-19 pandemic. Roche is working closely with healthcare providers around the world, and has significantly increased production to provide tests globally.

According to Roche, no major manufacturing supply chain issues have been identified and the Groups planned drug launches, filings, pivotal phase III study readouts and pivotal trial starts are largely on track.

The global phase III randomized, double-blind, placebo-controlled clinical study COVACTA was initiated to assess the safety and efficacy of intravenous Actemra/RoActemra plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. The first patients were enrolled during early April.

On July 29, Roche reported that the COVACTA study did not meet the primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality. Roche remains dedicated to continuing the Actemra/RoActemra clinical study program in COVID-19 to further explore the product in other treatment settings, including in combination with an antiviral.

The global phase III, randomized, double-blind, multicenter study REMDACTA was initiated to assess the safety and efficacy of Actemra/RoActemra plus the antiviral remdesivir, versus placebo plus remdesivir in hospitalized patients with severe COVID-19 pneumonia. In collaboration with Gilead Sciences, the clinical trial began enrollment during June. Data from the REMDACTA study are designed to supplement the phase III COVACTA trial; results were anticipated during 2020.

Results from Roches phase III EMPACTA study reported in September demonstrated that Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalized patients with COVID-19 associated pneumonia. EMPACTA represents the first worldwide phase III study to show efficacy with Actemra/RoActemra in COVID-19 associated pneumonia and the first trial with a focus on enrolling largely underserved and minority patients. Started in the United States during May 2020, the trial was expanded to sites in other countries, including Brazil, Kenya, Mexico, South Africa and Peru.

MARIPOSA a worldwide phase III randomized, double-blind, placebo-controlled study was initiated to test the safety and efficacy of 8 mg/kg vs 4 mg/kg intravenous Actemra/RoActemra plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia. Results were expected to be reported during 2020.

Roche additionally launched an internal early research program focused on the discovery of medicines for COVID-19 and is assessing a large number of potential collaborations. As of July, six Roche medicines including Actemra/RoActemra, Esbriet, Avastin and Pulmozyme already approved for other diseases, were being evaluated in 28 Roche or Roche-supported clinical studies in COVID-19 infection. Several new compounds also are being evaluated in pre-clinical research.

Roche and Regeneron joined forces during August in the fight against COVID-19. The companies agreed to develop, manufacture and distribute REGN-COV2, Regenerons investigational antiviral antibody combination, to people worldwide. REGN-COV2 could provide a much-needed treatment option for people already experiencing COVID-19 symptoms and has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic. The collaboration is anticipated to increase supply of REGN-COV2 to at least three-and-a-half times the current capacity, with the potential for additional expansion.

Roches Elecsys IL-6 test received FDA Emergency Use Authorization in June to help in identifying patients at high risk of severe inflammatory response in patients with confirmed COVID-19. Interleukin 6 is an early indicator for acute inflammation to aid in the management of critically ill patients, according to Roche. The test is additionally available in markets accepting the CE Mark.

Roche filed for Emergency Use Authorization (EUA) from the U.S. FDA for the Elecsys Anti-SARS-CoV-2 S antibody test, which launched in September for markets accepting the CE Mark. Roche says using the Elecsys Anti-SARS-COV-2 S antibody test, together with the Elecsys Anti-SARS-CoV-2 test that was issued EUA during May, can help to more effectively determine the percentage of a population who already have antibodies against SARS-COV-2. According to Roche, the high specificity of the Elecsys Anti-SARS-CoV-2 antibody test is crucial to determine reliably if a person has been exposed to the virus and if the patient has developed antibodies.

Pharma Product Approvals & Pipeline Updates During 2020

Regulatory authorities worldwide granted approvals for new Roche medicines, line extensions of existing products and new tests during 2020. In the second quarter alone, Roche completed phase III trial enrollment for pivotal studies in Alzheimers and Huntingtons disease and started four significant phase III trials in oncology.

The U.S. FDA approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) in early June for treating people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. This is the first cancer immunotherapy regimen approved for the treatment of unresectable or metastatic HCC. The marketing application was reviewed under the FDAs Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring the new treatment option rapidly to patients in the United States and around the globe.

During September, the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Tecentriq in combination with Avastin for the treatment of adults with advanced or unresectable HCC who have not received prior systemic therapy.

Tecentriq won U.S. regulatory clearance in May as a first-line treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained 50% of tumor cells [TC 50%] or PD-L1 stained tumor-infiltrating covering 10% of the tumor area [IC 10]), as determined by an FDA-approved test), with no EGFR or ALK genomic tumor aberrations.

Near the end of July, the U.S. regulatory agency granted approvals for Tecentriq plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) for people with advanced melanoma. The supplemental Biologics License Application for Tecentriq was approved under priority review. The review was additionally performed under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology products among international partners.

During September, Roche presented new data from multiple phase III trials of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020. Data from the phase III IMpassion031 trial showed that Tecentriq in combination with chemotherapy improved pathological complete response for patients with early triple-negative breast cancer (TNBC), when compared to placebo plus chemotherapy. Final overall survival data from the phase III IMpassion130 trial were consistent with previous interim analyses in patients with metastatic TNBC, whose tumors expressed PD-L1 and who received Tecentriq plus nab-paclitaxel. Results from the phase III IMpassion131 study, assessing Tecentriq in combination with paclitaxel for treating people with metastatic TNBC and whose tumors expressed PD-L1, did not meet the trials primary endpoint of progression-free survival.

Gavreto was the recipient of U.S. marketing approval during September for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer. Composed of the active chemical pralsetinib, the once-daily, oral precision therapy selectively inhibits RET-altered cancers. Gavreto also garnered FDA Priority Review for treating people with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer.

Genentech and Blueprint Medicines are joint commercialization partners for pralsetinib in the United States via a deal announced in July. Roche obtained co-development and co-commercialization rights for the investigational medicine, which is also in late-stage development for various types of thyroid cancer and other solid tumors. Roche is additionally responsible for commercial activities outside the United States, excluding Greater China.

U.S. health regulators granted approval in August to Evrysdi (risdiplam) for the treatment of spinal muscular atrophy (SMA) in adults and children 2 months and older. Evrysdi represents the first medicine for SMA that can be administered at home. In two clinical studies, the medicine improved motor function in people living with SMA over a broad spectrum of ages and levels of disease severity, including Types 1, 2, and 3 SMA. Evrysdi helped infants survive without permanent ventilation and achieve the ability to sit without support, regarded as a key motor milestone not typically seen in the natural course of the disease.

Roche unveiled in late September new 2-year data from Part 1 of the pivotal FIREFISH study of Evrysdi in infants aged 2-7 months with symptomatic Type 1 SMA. The 2-year results in infants treated with the therapeutic dose of Evrysdi (17/21) demonstrated that they continued to improve and achieve motor milestones. Exploratory efficacy data demonstrated 88% of infants treated with Evrysdi were alive and did not require permanent ventilation at two years, and 59% of infants were able to sit without support for at least 5 seconds.

Data unveiled in June of an exploratory efficacy analysis from Part 1 of the pivotal SUNFISH study in people aged 2-25 years with type 2 or 3 SMA demonstrate that risdiplam significantly improved motor function after 24 months of treatment compared to natural history data. Also, preliminary 12-month data from JEWELFISH a study in people with all types of SMA aged 6 months to 60 years previously treated with other SMA therapies demonstrated that treatment with risdiplam resulted in rapid and sustained increases in SMN protein levels.

One-year data reported in April from FIREFISH Part 2 demonstrate that the study met the primary endpoint with 29% of infants sitting without support for five seconds by month 12, as assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development Third Edition.

Enspryng (satralizumab-mwge) won marketing clearance in August as the first FDA-approved subcutaneous treatment option for anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD) that can be self-administered by a person with NMOSD or a caregiver every four weeks. Enspryng is additionally the first approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology. The U.S. approval was supported by one of the largest clinical study programs undertaken for this rare disease.

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Roche 2020: Built for innovation PharmaLive - PharmaLive