Johnson & Johnson 2022Q3: blockbuster products face patent cliff, ibrutinib is "besieged"

A few days ago, Johnson & Johnson released its third-quarter 2022 financial report, with global revenue of $23.
791 billion, an increase of 1.
9% year-on-year; Net profit was US$4.
458 billion, a year-on-year increase of 21.
6%.

Johnson & Johnson's global revenue mainly includes three major segments: pharmaceutical business, medical device business and consumer health care business
.

Among them, the revenue of pharmaceutical business was 13.
214 billion US dollars, a year-on-year increase of 2.
6%, including six major business segments: immunology, infectious diseases, neuroscience, oncology, pulmonary hypertension, and cardiovascular/metabolic business; Medical device business revenue was US$6.
782 billion, a year-on-year increase of 2.
1%, including interventional, orthopedics, vision care, and surgery; Consumer Healthcare revenue decreased 0.
4%
year-over-year to $3,795 million.

2022Q3 Johnson & Johnson business revenue

Based on third-quarter performance, Johnson & Johnson's sales growth was mainly from the self-immunity and oncology segments
.
Let's take a look at blockbuster drug sales
.

Sales of ustekinumab, a blockbuster product in the field of self-exemption, exceeded $2 billion, but the patent cliff is coming

In the third quarter, Johnson & Johnson's self-immunity revenue was $4.
287 billion, up 0.
9%
year-over-year.
Among them, the ace product ustekinumab (Starno, ustekinumab, Stelara) revenue was 2.
449 billion US dollars, a year-on-year increase of 3%.

Usenumab was approved by the FDA in 2009 for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis
.
In 2019, ustekinumab was approved for marketing in China for the treatment of adult patients with moderate to severe plaque psoriasis, and was the first inhibitor
approved in China to target interleukin 12 (IL-12) and IL-23.

At present, ustekinumab is approved for use in nearly 90 countries or regions around the world, and more than 2 million patients receive ustekinumab treatment regimen
.
In 2021, ustekinumab had global sales of $9.
134 billion, making it a veritable blockbuster
.
However, the U.
S.
patent for ustekinumab expires in 2023, when Johnson & Johnson will face competition
for generic drugs.

In addition to ustekinumab, Johnson & Johnson immunity includes Tremfya, Infliximab (Remicade), Golimumab (Simponi) and so on
.
Among them, gusecumab is a biological agent targeting IL-23, which is a regulator of the core pathway of psoriasis
.
In the third quarter of this year, gusecumab sales were $729 million, a year-on-year increase of 35.
9%.

Infliximab is a human mouse chimeric IgG1 monoclonal antibody targeting tumor necrosis factor (TNF-α) for the treatment of a variety of autoimmune diseases, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, and ankylosing spondylitis
.
In the third quarter of this year, infliximab sales were $558 million, a year-on-year decrease of 26.
6%.

Golimumab is a fully humanized anti-TNF-α monoclonal antibody drug that targets and neutralizes the soluble and transmembrane-active form of TNF-α, preventing it from binding to TNF receptors, thereby inhibiting the biological activity
of TNF.
In 2009, golimumab was approved by
the FDA.
At present, golimumab is approved worldwide for rheumatoid arthritis, ankylosing spondylitis, psoriasis, ulcerative colitis, ankylosing spondylitis, etc
.
In the third quarter of this year, gollimumab sales were $545 million, a year-on-year decrease of 4.
6%.

Oncology: A number of products are good, and the performance of ibrutinib continues to decline

In the third quarter, Johnson & Johnson's oncology business generated total revenue of $4.
064 billion, up 10.
9%
year-over-year.
Among them, darazalex, as the world's first approved fully human monoclonal antibody targeting CD38, is mainly indicated for multiple myeloma, which was approved by the FDA in 2015 and has been approved for marketing
in many countries around the world 。 In the third quarter of this year, the revenue of daratumumab was 2.
052 billion US dollars, a year-on-year increase of 29.
8%; As a new generation of androgen receptor (AR) inhibitors, mainly for the treatment of prostate cancer, apattamide inhibits the growth of cancer cells by blocking the androgen signaling pathway in prostate cancer cells, and in the third quarter of this year, apattamide sales were $490 million, a year-on-year increase of 42.
2%.

Johnson & Johnson's ibrutinib is the world's first marketed BTK inhibitor, approved by the FDA in November 2013 for the treatment of mantle cell lymphoma (MCL), and currently ibrutinib is also approved for the treatment of graft-versus-host disease, marginal zone lymphoma, small lymphocytic lymphoma, Fahrenheit macroglobulinemia, chronic lymphoblastic leukemia, etc
.

BTK plays a key role
in the occurrence and development of tumors.
At present, BTK inhibitors are a hot spot in research and development worldwide, and there are 5 BTK drugs on the market, in addition to ibrutinib, there are orelabrutinib, zebrutinib, telutinib hydrochloride, and akalutinib
.
As the leader in the BTK inhibitor track, ibrutinib dominates, with sales of $9.
8 billion last year, accounting for 87%.

However, since the beginning of this year, due to the influence of competitors, the sales performance of ibrutinib has shown a downward trend
.
In 2022H1, ibrutinib sales were $2.
008 billion, down 10.
4%
year-on-year.
In the third quarter of this year, ibrutinib sales were $911 million, a year-on-year decrease of 14.
6%.

Ibrutinib is currently suffering from stiff competition
from competitors.
Especially zebrutinib
from BeiGene.
On October 12 of this year, BeiGene announced that zebrutinib achieved a favorable result
of progression-free survival (PFS) compared with ibrutinib in the global phase III ALPINE trial.

Shortly after the results of the ALPINE trial were announced, on October 14, Simcere Pharmaceutical ibrutinib capsules were approved for marketing by the State Food and Drug Administration and are the first imitation
of ibrutinib.
In addition, domestic Hisun Pharmaceutical, CP Tianqing, etc.
are also laying out the research and development of ibrutinib generic drugs, and it is conceivable how fierce
the competition for domestic BTK inhibitors will be in the future.

Spin-offs and layoffs go hand in hand

On this year's third-quarter earnings call, Johnson & Johnson said it would spin off its consumer health business, Kenvue, to be completed by the end of next year, and on October 21, Endpoints reported that Johnson & Johnson would lay off more than 60 jobs
in its New York office due to economic factors.

Despite the patent cliff crisis and declining sales of core products, Johnson & Johnson remains optimistic, setting a sales target of $60 billion
by 2025.
Under the new strategy, what is the future development of Johnson & Johnson? We keep watching
.

Reference sources:

1.
Johnson & Johnson 2022Q3 financial report;

2.
J&J sets sights on $60B in pharma sales by 2025, targets 8 brands to deliver growth； fiercepharma.