Fidanacogene elaparvovec is a gene therapy commercialized by Pfizer, with a leading Phase III program in Hemophilia B (Factor IX Deficiency). According to Globaldata, it is involved in 7 clinical trials, of which 3 were completed, 3 are ongoing, and 1 was terminated. GlobalData uses proprietary data and analytics to provide a complete picture of Fidanacogene elaparvovec’s valuation in its risk-adjusted NPV model (rNPV). Buy the model here.

The revenue for Fidanacogene elaparvovec is expected to reach an annual total of $204 mn by 2036 in the US based off GlobalData’s Expiry Model. The drug’s revenue forecasts along with estimated costs are used to measure the value of an investment opportunity in that drug, otherwise known as net present value (NPV). Applying the drug’s phase transition success rate to remaining R&D costs and likelihood of approval (LoA) to sales related costs provides a risk-adjusted NPV model (rNPV). The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress.

Fidanacogene elaparvovec Overview

Fidanacogene elaparvovec (SPK-9001, PF-06838435) is under development for the treatment of hemophilia B. The therapeutic candidate is administered by intravenous route as a solution. The therapeutic candidate uses an engineered adeno-associated virus to deliver the human FIX gene (AAV8-hFIX19 vector) to liver cells, where FIX is normally made. It is a new molecular entity.

Pfizer Overview

Pfizer discovers, develops, manufactures and commercializes biopharmaceuticals. The company offers products to treat various conditions such as cardiovascular, metabolic and pain, cancer, inflammation, immune disorders and rare diseases. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services. Pfizer sells its products through wholesalers, retailers, hospitals, clinics, government agencies and pharmacies. It has major manufacturing facilities in India, China, Japan, Ireland, Italy, Belgium, Germany, Singapore, and the US. The company provides its products in North America, South America, Asia-Pacific, Australia, Europe, Africa and the Middle East. Pfizer is headquartered in New York, the US.

The company reported revenues of (US Dollars) US$100,330 million for the fiscal year ended December 2022 (FY2022), an increase of 23.4% over FY2021. The operating profit of the company was US$36,551 million in FY2022, compared to an operating profit of US$23,652 million in FY2021. The net profit of the company was US$31,372 million in FY2022, compared to a net profit of US$21,980 million in FY2021.

For a complete picture of Fidanacogene elaparvovec’s valuation, buy the drug’s risk-adjusted NPV model (rNPV) here.

GlobalData

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, drug margins and company expenses. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate valuation, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA) and phase transition success rate (PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.