Pfizer’s R&D pipeline
In its first-quarter earnings release, Pfizer (PFE) guided for YoY (year-over-year) mid-single-digit operational revenue growth from 2020 to 2025. Pfizer has discontinued a few of the 15 R&D (research and development) programs it previously believed had blockbuster potential. However, there are still multiple investigational therapies as well as label expansion programs in the company’s R&D pipeline that could prove to be major revenue drivers for it in the coming years. After 2020, Pfizer also doesn’t expect any significant loss of exclusivity until 2025.
Key regulatory approvals YTD
As we discussed in the previous article, Ibrance was approved in metastatic breast cancer indications in males, which was the first regulatory approval for the drug based on real-world data.
In February 2019, Pfizer issued a press release announcing the European Commission’s approval of Zirabev, a biosimilar of Avastin, in advanced or metastatic cancer indications approved for the reference drug. On April 3, the company issued a press release announcing the European Commission’s approval of Vizimpro as a first-line therapy for EGFR (epidermal growth factor receptor) mutated locally advanced or metastatic NSCLC (non-small cell lung cancer) patients. In March 2019, Pfizer issued a press release announcing the FDA’s approval of Trazimera, a biosimilar of Herceptin, in HER2 (human epidermal growth factor receptor-2) overexpressing cancer indications such as breast cancer and metastatic gastric cancer.
Tafamidis’s growth prospects
On May 6, Pfizer issued a press release announcing the FDA’s approval of Vyndaqel and Vyndamax, both with the active ingredient tafamidis, in ATTR-CM (cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis) indications. Vyndaqel already secured approval in this indication in March 2019. With an annual list price of $225,000 in the United States, Refinitiv expects tafamidis to cross the $1.0 billion revenue mark by 2024.
According to its first-quarter earnings conference call, Pfizer estimates that there are ~100,000 eligible patients for tafamidis in the United States. However, diagnosis rates for this disease are lower than 1% due to the use of invasive biopsies as well as the absence of treatment options. To address these problems and increase diagnosis rates, Pfizer plans to focus on educating cardiologists about signs and symptoms in cardiomyopathy. The company also plans to increase the usage of noninvasive diagnosis methods such as scintigraphy.