Roche Reports Strong 2019 Financial Results: Tecentriq and Hemlibra Surge, China Sales Up 36%

 Roche Announces 2019 Financial Results Today，EntireCompanyAchieved throughout the yearRevenue615100 million Swiss francs, year-on-year increase8%, among whichPharmaceutical DivisionIncomeCHF 48.5 billion（+10%），DiagnosisDepartmentRevenueCHF 12.9 billion (+1%）。Operating profit reached175.48CHF 100 million，Year-on-year growth19%；Cash Flow Growth13% to167.64100 million yuan.

In terms of specific products, the original oncology "three musketeers"—bevacizumab (RMB 7.073 billion, +4%), trastuzumab (RMB 6.039 billion, -12%), and rituximab (RMB 6.477 billion, -4%)—remained largely stable, while new products saw rapid volume growth: Tecentriq (RMB 1.875 billion, +143%), Hemlibra (RMB 1.38 billion, >500%), and Ocrevus (RMB 3.708 billion, +57%).Sales in China reached CHF 3.062 billion, an increase of 36%.Among them, rituximab increased by 16%;The HER2 franchise (Herceptin, Perjeta, and Kadcyla) grew by 59%;Bevacizumab Increased by 47%。

Top 11 Products by Sales in 2019

HER2 franchise：Herceptin + Perjeta + Kadcyla

Herceptin has become HER2+ since its approvalBreast Cancerthe gold standard for patient treatment, but as patents expire, it faces impact from biosimilars,Its 2019 sales fell by 12% to CHF 6.039 billion。To address the impact of the expiration of the trastuzumab patent, Roche had strategically positioned itself in the early years byPerjeta and Kadcyla, with 2019 sales of CHF 3.522 billion (+29%) and CHF 1.393 billion (+45%), respectively）。In Q4 2019, the sales of Perjeta + Kadcyla surpassed those of Herceptin, with the annual sales of the HER2 “trio” reaching CHF 10.9 billion in 2019.

CD20 franchise：Rituxan + Ocrevus + Gazyva

Rituxan’s sales in 2019 amounted to CHF 6.477 billion (-4%), of which CHF 4.89 billion came from the oncology segment, auto-ImmunityThe portion amounts to USD 1.587 billion.

Gazyva is a second-generation anti-CD20 monoclonal antibody developed in response to the expiration of Rituxan’s patent. It features enhanced ADCC activity through Fc region engineering, although its epitope differs slightly from that of Rituxan.Gazyva’s sales reached CHF 552 million (+43%) in 2019, including its use in combination with the BTK inhibitor ibrutinib as first-line treatment for CLL, and in combination with the Bcl-2 inhibitor Venclexta as first-line treatment for AML, will further solidify Gazyva's position.Furthermore, in September 2019, Gazyva was granted Breakthrough Therapy Designation (BTD) for the treatment of adult patients with lupus nephritis, holding promise to address this unmet medical need., sales are expected to experience rapid growth following approval.In terms of product substitution for HER2 and CD20, Roche has performed exceptionally well in product innovation and maintenance.

Ocrelizumab is a humanized anti-CD20 monoclonal antibody that was approved for marketing in March 2017 for the treatment of adult patients with relapsing or primary progressive multiple sclerosis (RRMS and PPMS).Given that the maintenance dose of ocrelizumab is 600 mg every six months, the semi-annual dosing regimen offers better adherence., and it rapidly gained market traction after launch,Its sales reached CHF 3.708 billion (+57%) in 2019。

Tecentriq

2019 was also a fruitful year for Tecentriq,In March, Tecentriq was approved for first-line treatment of SCLC and TNBC, marking the first approval of PD-1/PD-L1 inhibitors as first-line therapy for these two types of tumors.Furthermore, Tecentriq was approved in December for use in combination with albumin-bound paclitaxel for non-squamousNSCLCfirst-line treatment.Benefiting from the approval of new indications,Tecentriq’s sales increased by 143% in 2019, reaching CHF 1.875 billion.。

In the expansion to other indications, Tecentriq in combination with Avastin is also poised to take the lead in first-line liver cancer treatment.IMbrave150ClinicalThe results showed that, compared with the current standard first-line therapy sorafenib, Tecentriq + Avastin significantly improved patients' OS (HR=0.58).Currently, the company has already submitted toFDASubmitted BLA application, expected to be approved in the first half of 2020, providing new momentum for its growth.

Hemlibra

Hemlibra is an IgG4 bispecific antibody with affinity for coagulation factor IXa and coagulation factor X, mimicking FVIIIa in vivo to enable FIXa to catalyze the formation of FXa from FX, thereby exerting its procoagulant effect.。For patients with anti-FVIII antibodies, Hemlibra still works well;Furthermore, compared with recombinant coagulation factors administered twice weekly, Hemlibra enables dosing every 2 weeks (Q2W) or even every 4 weeks (Q4W), resulting in better adherence.Therefore, since the launch of Hemlibra, sales have grown rapidly, with its 2019 sales revenue increasing by over 500% to reach CHF 1.38 billion.。

However, Hemlibra may need to face direct competition from gene therapies in the future.BioMarin’s gene therapy for hemophilia A, BMN 270, has recently submitted a Biologics License Application (BLA), while Spark’s SPK-8011 and Sangamo/Pfizer’s SB-525 are both in Phase III clinical trials.Clinical。In theory, gene therapy requires only a single treatment to achieve a "curative" effect, resulting in better adherence.Hemlibra may be significantly impacted following the market launch of gene therapies.

M&A Transactions in 2019

In December 2019, Roche officially completed the acquisition of SPARK.。SPARK holds the first gene therapy product approved in the United States, Luxturna, and its gene therapy candidates SPK-8011 for hemophilia A and SPK-9001 for hemophilia B are currently in Phase III clinical trials.Amid the growing momentum in gene therapy, SPARK has provided Roche with a comprehensive gene therapy platform and future growth drivers.

In November 2019, Roche announced the acquisition of Promedior for $1.4 billion, gaining access to its Phase II candidate drug PRM-151 for pulmonary fibrosis and myelofibrosis.。PRM-151 is a recombinant human pentraxin-2 protein that has received Breakthrough Therapy designation for the treatment of idiopathic pulmonary fibrosis (IPF).There is a significant unmet need in the field of idiopathic pulmonary fibrosis (IPF). Currently, the only approved drugs are Roche’s pirfenidone and Boehringer Ingelheim’s nintedanib, both of which are blockbuster drugs with annual sales exceeding $1 billion.If PRM-151 is ultimately approved for market launch, it holds significant potential.

Highlights of 2020

In addition to the aforementioned use of Tecentriq + Avastin for first-line HCC and Gazyva for lupus nephritis, there are several other areas to look forward to in 2020.

First, the oral SMA medication RisdiplamRisdiplam improves symptoms in patients with SMA by modulating the alternative splicing of SMN2.In the FIREFISH Phase III clinical trial, risdiplam significantly improved symptoms in patients with Type I SMA.Roche submitted its New Drug Application (NDA) to the FDA in November 2019; after market approval,Will compete with Ionis/Biogen’s ASO drug Spinraza and Novartis’s gene therapy Zolgensma for the SMA market。

Next is satralizumab, an IL-6R antibody for the treatment of neuromyelitis optica spectrum disorder (NMOSD).。The results of its Phase III clinical SAKURA SKY study showed that satralizumab in combination withImmunityInhibitor therapy can significantly reduce the risk of relapse in patients with NMOSD.Currently, the C5 complement antibody eculizumab was approved in June 2019 for the treatment of NMOSD. In addition, Viela Bio’s CD19 antibody inebilizumab submitted a Biologics License Application (BLA) in August 2019.If satralizumab is approved in 2020, it will compete with the above two agents. Compared with the Q2W dosing regimen of eculizumab, the Q4W dosing regimen of satralizumab offers certain advantages in terms of patient compliance.

Roche and Genentech’s innovations never disappoint, with a robust pipeline that promises to deliver more products in the future.

China Region Surges 36%

China has also become an important growth driver for Roche’s Pharmaceuticals Division, thanks to increased product penetration.Sales in China reached CHF 3.062 billion, an increase of 36%。Among them, rituximab increased by 16%;The HER2 franchise (Herceptin, Perjeta, and Kadcyla) grew by 59%;Bevacizumab increased by 47%。Furthermore, in terms of drug review and approval, the new indications for pertuzumab in neoadjuvant therapy and first-line treatment for advanced disease were approved, and it was included in the 2019 National Reimbursement Drug List.Alectinib’s first-line treatment has also been approved and successfully included in the national medical insurance, with the entire China region continuing to maintain strong growth potential.