PFIZER INC: FUNDAMENTAL ANALYSIS REPORT+NEXT TARGET|MUST READ 🔔Late last month, Pfizer announced that its drug abrocitinib had been approved by Japan's Ministry of Health, Labor and Welfare (MHLW) as a treatment for patients aged 12 and older with moderate to severe atopic dermatitis or eczema.
The Japanese approval of abrocitinib under the trade name Cibinqo came just weeks after the UK Medicines and Healthcare Products Regulatory Agency (MHRA) approved the drug for adults and adolescents with moderate to severe eczema. Let's take a look at why the MHLW approved the drug for use in eczema, as well as its sales potential and what it means for Pfizer.
Typically, first-line therapy for eczema patients is topical corticosteroids (TCS), which are effective in treating most eczema patients. But for the large minority of eczema patients who do not experience significant benefits from TCS, there is a huge unmet medical need. And this is where Pfizer's Cibinqo can make a big difference in treating complex eczema cases.
For context, the leading eczema drug is Dupixent, which was developed jointly by Regeneron and Sanofi. Dupixent is also approved as a complementary treatment for a type of asthma and chronic rhinosinusitis with nasal polyps, bringing the drug's sales to more than $8 billion last year. And although Pfizer will release the full results of the drug's latest phase 3 trial later, Cibinqo was found to outperform Dupixent in all measures of efficacy. More patients who received 200 milligrams of Cibinqo once daily compared to 300 mg of Dupixent once every two weeks reported a four-point improvement in peak itch severity on the numeric rating scale in the second week of treatment compared to baseline levels before treatment.
Simply put, the Peak Itch Digital Rating Scale is used by health care providers to measure the intensity of itching in patients with moderate to severe eczema. Although full study data have not yet been published, Cibinqo has demonstrated greater efficacy than Dupixent in reducing itching in patients with eczema in the second week of treatment. This should lead to an improvement in the quality of life of eczema patients.
With a better understanding of Cibinqo's effectiveness in treating eczema, we can now explore the sales potential of this drug for Pfizer. Cibinqo's Phase 3 clinical trial showing higher efficacy compared to Dupixent is certainly an advantage. However, in the coming months, when Pfizer presents additional data, it will become clear how much of an efficacy advantage Cibinqo has over Dupixent.
This is because last month the U.S. Food and Drug Administration (FDA) issued new warnings for Janus kinase inhibitors such as Cibinqo. This may encourage health care providers worldwide to exercise caution when prescribing Cibinqo in favor of Dupixent if the benefits are deemed to outweigh the risks compared to Dupixent. The encouraging news for Cibinqo is that, at first glance, the percentage of patients who discontinued Cibinqo was similar to those who discontinued Dupixent because of adverse events.
There are approximately 105 million adults in Japan, and given that the prevalence of eczema among adults is estimated at 6.5%, there are 6.8 million adults with eczema. Since 23.3% of eczema cases in Japan are estimated to be moderate to severe, there are about 1.6 million adults with moderate to severe eczema. Of these 1.6 million, about 19% will not be able to control their symptoms with TCS alone. Thus, the real market of adult patients in Japan with moderate to severe eczema for Cibinqo is about 300,000. Cibinqo is expected to win 10% or 30,000 of these patients, which conservatively accounts for the remaining efficacy and safety issues of Cibinqo compared to the leader Dupixent.
Since the Institute for Economic and Clinical Analysis estimates that the annual price in the United States is between $30,000 and $40,000, and prescriptions in Japan are on average 43% cheaper than in the United States, Cibinqo would have a net price of $10,000 per year. Thus, this eczema indication should generate about $300 million in annual revenue for Pfizer in Japan alone. Although this is a fraction of a percent compared to Pfizer's expected revenue of $78 billion to $80 billion this year, it is a good additional income for the company.
Although Cibinqo looks like a promising new drug for Pfizer, the company is not idly waiting for results. While established drugs such as the COVID-19 Comirnaty vaccine and the Prevnar-13 pneumonia vaccine are generating significant revenue, Pfizer is working to discover, research, and commercialize the next line of breakthrough drugs.
Pfizer, for example, recently increased its research and development spending from $3.8 billion in the first half of last year to $4.5 billion this year. While no guarantee increased R&D spending will lead to the discovery of more drugs and approvals, it's the best chance pharmaceutical stocks have at innovating and staying relevant. That's why Pfizer's dividend yield of 3.7% is safe for the foreseeable future and is the best choice in its sector for stable income.
