Tividenofusp alfa is a fusion protein commercialized by Denali Therapeutics, with a leading Phase III program in Mucopolysaccharidosis II (MPS II) (Hunter Syndrome ). According to Globaldata, it is involved in 3 clinical trials, which are ongoing. GlobalData uses proprietary data and analytics to provide a complete picture of Tividenofusp alfa’s valuation in its risk-adjusted NPV model (rNPV). Buy the model here.
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The revenue for Tividenofusp alfa is expected to reach an annual total of $34 mn by 2039 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.
Tividenofusp alfa Overview
DNL-310 is under development for the treatment of mucopolysaccharidosis II. The drug candidate is administered through intravenous route.The drug candidate consists of iduronate 2 sulfatase enzyme fused to Fc domain. It is developed based on enzyme transport vehicle (ETV) platform.
Denali Therapeutics Overview
Denali Therapeutics is a clinical-stage biopharmaceutical company that develops a portfolio of product candidates engineered to cross the blood-brain barrier for neurodegenerative diseases and lysosomal storage diseases. The company’s proprietary platform technology called the Transport Vehicle enabled programs include tividenofusp alfa (DNL310, ETV:IDS) for mucopolysaccharidosis II (MPS II or Hunter syndrome); BIIB122/DNL151 (LRRK2 inhibitor) for Parkinson’s disease; and DNL343 (eIF2B activator) for amyotrophic lateral sclerosis (“ALS”). Its pipeline products include Iduronate 2-sulfatase, LRRK2, Progranulin, Sulfamidase, Alpha-L-iduronidase, eIF2B and RIPK1 (Peripheral). The company’s pipeline products are intended for the treatment of Alzheimer’s disease, Parkinson’s disease, lysosomal storage disorder disease, neurodegeneration, amyotrophic lateral sclerosis and other indications. Denali Therapeutics is headquartered in San Francisco, California, the US.
The company reported revenues of (US Dollars) US$330.5 million for the fiscal year ended December 2023 (FY2023), compared to a revenue of US$108.5 million in FY2022. The operating loss of the company was US$196.7 million in FY2023, compared to an operating loss of US$340.7 million in FY2022. The net loss of the company was US$145.2 million in FY2023, compared to a net loss of US$326 million in FY2022.
For a complete picture of Tividenofusp alfa’s valuation, buy the drug’s risk-adjusted NPV model (rNPV) here.
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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.
