Roche : Full-Year 2022 Investor Update

Media Release

Ad hoc announcement pursuant to Art. 53 LR

Basel, 2 February 2023

Roche reports good results for 2022 despite decline in demand for COVID-19 products

• Group sales grow by 2%1 at constant exchange rates (CER) and 1% in Swiss francs, despite lower COVID-19-related sales in both divisions
• Pharmaceuticals Division sales increase by 2%; continued strong growth of newer medicines more than compensating for the impact of biosimilars and lower sales of Actemra/RoActemra (severe COVID-19)
• Diagnostics Division sales grow by 3%; ongoing strong momentum in base business (+7%) more than compensating for the continuing decline in the demand for COVID-19 tests in the second half of the year
• Highlights in the fourth quarter of 2022 (incl. January 2023):
• • US approvals of Lunsumio (follicular lymphoma), Tecentriq (advanced rare sarcoma) and Actemra/RoActemra (COVID-19)
  • US priority review of glofitamab (aggressive form of blood cancer)
  • Positive phase III data for Vabysmo (serious retinal vascular condition) and for Tecentriq plus Avastin (early-stage liver cancer)
  • Priority review for crovalimab (rare blood disease) in China
  • New study proves high medical value of Elecsys NT-proBNP heart test
  • US approval for Alzheimer's tests; US Emergency Use Authorization for mpox virus test
• Core earnings per share rise by 5% (+2% in CHF)
• IFRS net income amounts to CHF 13.5 billion (-6%;-9% in CHF)
• Board proposes dividend increase to CHF 9.50. If approved by shareholders, this would be the 36th consecutive dividend increase.

F. Hoffmann-La Roche Ltd	4070 Basel	Group Communications	Phone [phone]
	Switzerland	Roche Group Media Relations	www.roche.com

1/15

Outlook for 2023

Due to the sharp decline in sales of COVID-19 products of roughly CHF 5 billion, Roche expects a decrease in Group sales in the low single digit range (at constant exchange rates). Excluding this COVID-19 sales decline, Roche anticipates solid underlying sales growth in both divisions.

Core earnings per share are targeted to develop broadly in line with sales decline (at constant exchange rates). Roche expects to further increase its dividend in Swiss francs.

Key figures	CHF millions		% change
January-December 2022	2022		2021	At CER1		In CHF
Group sales	63,281		62,801	2		1
Pharmaceuticals Division	45,551		45,041	2		1
Diagnostics Division	17,730		17,760	3		0
Core operating profit	22,173		21,897	3		1
Core EPS - diluted (CHF)	20.30		19.81	5		2
IFRS net income	13,531		14,935	-6		-9

Roche CEO Severin Schwan: "We achieved good results in 2022, even though the demand for COVID-19 products declined, as expected. The diagnostics base business and our newer medicines continued their strong growth. While we had pipeline setbacks in 2022, I am particularly pleased that we brought two new medicines to patients: Vabysmo for certain severe eye diseases and Lunsumio for a currently incurable form of blood cancer. For the current year we expect solid underlying growth in both divisions, which will largely compensate for the further significant drop in sales of roughly CHF 5 billion in COVID-19 products."

F. Hoffmann-La Roche Ltd	4070 Basel	Group Communications	Phone [phone]
	Switzerland	Roche Group Media Relations	www.roche.com
			2/15

Group results

In 2022, Roche achieved sales growth of 2% (+1% in CHF) to CHF 63.3 billion.

Core operating profit increased by 3% (+1% in CHF), reflecting the good underlying business performance.

IFRS net income was CHF 13.5 billion, a decrease of 6% compared to the previous year. This was due to higher impairment of intangible assets and higher interest costs and income taxes.

Core earnings per share increased by 5% (+2% in CHF). This includes the positive impact of the repurchase of Roche shares held by Novartis.

Sales in the Pharmaceuticals Division increased by 2% to CHF 45.6 billion. Newer medicines to treat severe diseases continued their strong growth. Vabysmo, an eye medicine launched at the beginning of 2022, is already one of the top five growth drivers. This medicine, together with Ocrevus (multiple sclerosis), Hemlibra (haemophilia), Evrysdi (spinal muscular atrophy) and Tecentriq (cancer), generated additional sales totalling CHF 3.2 billion.

Sales of COVID-19 medicines were generally lower (with a decline of roughly CHF 0.5 billion): the drop in sales of Actemra/RoActemra (severe COVID-19 pneumonia) was only partially made up by the sales growth of Ronapreve (high-risk patients) in Japan.

As expected, the impact of biosimilars on the sales of the cancer medicines MabThera/Rituxan, Herceptin and Avastin continued to slow down (combined CHF 1.9 billion of sales reduction).

Sales in the United States decreased slightly (-1%). The sales growth of the newer medicines Ocrevus, Vabysmo, Hemlibra and Tecentriq partially compensated for the sales decline of Actemra/RoActemra (COVID-19) and medicines whose patents have expired.

In Europe, sales were also slightly down (-2%), mainly due to lower sales of the COVID-19 medicine Ronapreve. Excluding this base effect, sales in Europe increased by 6%, as the newer medicines more than offset the impact of biosimilars.

Sales in Japan increased by a substantial 26%. The key factors were supplies of Ronapreve to the government, followed by sales growth of Evrysdi, Polivy, Hemlibra and Enspryng. This more than offset the impact of biosimilars and government price cuts.

Sales in the International region grew by 1%. In China, sales decreased by 7% due to biosimilars, lower sales of Rocephin and local COVID-19 measures. Excluding China, sales in the region increased by 6%, mainly as a result of a higher demand for Perjeta, Hemlibra, Ocrevus and Kadcyla.

F. Hoffmann-La Roche Ltd	4070 Basel	Group Communications	Phone [phone]
	Switzerland	Roche Group Media Relations	www.roche.com
			3/15

The Diagnostics Division increased its sales by 3% to CHF 17.7 billion. The division's base business - up 7% - achieved good results over the year and across all regions. Growth was mainly driven by immunodiagnostic products.

Roche's broad portfolio of COVID-19 tests generated sales totalling CHF 4.1 billion in 2022 (2021: CHF 4.7 billion).

Sales in the Asia-Pacific and North America regions increased by 23% and 13%, respectively. The 16% drop in sales in the EMEA region is primarily due to the reduced demand for COVID-19 testing.

Pharmaceuticals Division: pipeline

In 2022, Roche brought two important new medicines to patients: Vabysmo (serious eye diseases) and Lunsumio (blood cancer). Currently, Roche has a total number of 87 new compounds and 65 additional indications in clinical development or registration.

Oncology remained the primary area for research and development, with the cancer immunotherapy portfolio a key driver. Ophthalmology, neuroscience and immunology represent other significant areas of late-stage investments.

Key regulatory approvals, filings and read-outs in the fourth quarter of 2022

(incl. January 2023)

Oncology and haematology

Roche reached a number of regulatory milestones and presented new data from its leading haematology portfolio, which spans numerous blood diseases, including haemophilia A, paroxysmal nocturnal haemoglobinuria (PNH) and various types of blood cancers.

• Data from the HAVEN 7 study reinforced the efficacy and safety of Hemlibra in infants with severe haemophilia A without factor VIII inhibitors. These initial results support the benefit of starting treatment with Hemlibra at birth, as early preventive treatment in infants.
• Based on the results of the HAVEN 6 study, the CHMP recommended the expansion of the EU label for Hemlibra to include people with moderate haemophilia A. If approved, Hemlibra will offer an effective and convenient prophylactic treatment option for these people.
• New and updated data supported the use of Polivy in diffuse large B-cell lymphoma (DLBCL), an aggressive form of blood cancer, including its potential as a treatment option for previously untreated patients. In January 2023, China simultaneously approved two indications: Polivy for the treatment of previously untreated DLBCL, and for relapsed or refractory DLBCL.

F. Hoffmann-La Roche Ltd	4070 Basel	Group Communications	Phone [phone]
	Switzerland	Roche Group Media Relations	www.roche.com
			4/15

• Positive new data from a phase III study in China demonstrated that crovalimab is effective and well-tolerated in people with PNH. PNH is an ultra-rare and life- threatening blood condition, where red blood cells are targeted and destroyed by the complement system, a part of the immune system. Based on these data, China granted priority review for approval of crovalimab.
• The FDA approved Lunsumio to treat people with relapsed or refractory follicular lymphoma (FL), a blood cancer that grows slowly, but is currently incurable. As a first- in-classT-cell-engaging bispecific antibody that can be initiated in an outpatient setting, Lunsumio with its high response rates and fixed duration could change the way advanced FL is treated.
• The FDA granted priority review for approval of glofitamab, a potential first-in-class bispecific antibody that may improve the lives of people with diffuse large B-cell lymphoma (DLBCL).
• Lunsumio and glofitamab are both part of Roche's leading programme for bispecific CD20xCD3 antibodies. Recently presented data further support the potential of these two compounds as effective, off-the-shelf,fixed-duration treatment options for people with blood cancer.

In December, the FDA approved Tecentriq as the first-ever therapy for certain advanced sarcoma (alveolar soft part sarcoma; ASPS). ASPS is a rare, insidious soft tissue sarcoma most common in younger people that is often advanced at diagnosis, can spread slowly but inexorably over decades, and often returns following surgery. For those diagnosed with advanced ASPS, only an estimated 20% will live for five years.

The FDA also accepted the Biologics License Application for the subcutaneous formulation of Tecentriq. If approved, this new formulation would be administered under the skin within minutes, compared with up to an hour for an infusion.

Today, more than 70% of people with early-stage liver cancer (hepatocellular carcinoma, HCC) may have their cancer return after surgery, which is associated with a poorer prognosis and shorter survival. In January, Roche reported positive results from the IMbrave050 study. It is the first phase III study to show that a cancer immunotherapy combination, Tecentriq plus Avastin, reduced the risk of a relapse in people with this type of liver cancer.

Ophthalmology

Vabysmo is the first bispecific antibody for the eye. It simultaneously targets and inhibits two signalling pathways that drive neovascular or 'wet' age-related macular degeneration (nAMD) and diabetic macular oedema (DME) - two of the leading causes of vision loss. Launched at the beginning of 2022, the eye medicine showed a strong uptake.

F. Hoffmann-La Roche Ltd	4070 Basel	Group Communications	Phone [phone]
	Switzerland	Roche Group Media Relations	www.roche.com
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