FDA Approves LungFX Device For Ex Vivo Lung Perfusion

Research evidence excerpt

FDA Approves LungFX Device For Ex Vivo Lung Perfusion

TD Cowen United Therapeutics

Global Research June 29, 2026

VALUATION METHODOLOGY AND RISKS

Valuation Methodology

Biotechnology:

In calculating our 12-month target price, we employ one or more valuation methodologies,

which include a discounted earnings analysis, discounted cash flow analysis, net present value

analysis and/or a comparable company analysis. These analyses may or may not require

the use of objective measures such as price-to-earnings or price-to-sales multiples as well as

subjective measures such as discount rates.

We make investment recommendations on certain early stage, pre-revenue companies based

upon an assessment of their business model, technology, probability of market success,

and the potential market opportunity, balanced by an assessment of applicable risks. Such

companies may not be assigned a price target.

Investment Risks

There are multiple risks that are inherent with an investment in the biotechnology sector.

Beyond systemic risk, there is also clinical, regulatory, and commercial risk. Additionally,

biotechnology companies require significant amounts of capital in order to develop their

clinical programs. The capital-raising environment is always changing and there is risk that

necessary capital to complete development may not be readily available.

Risks To The Price Target

United Therapeutics derives most of its product revenue from its pulmonary hypertension

franchise, most specifically Orenitram, Remodulin, Tyvaso, and Adcirca. Forecasting

sales for any product is difficult, and its outlook could be altered by new safety/efficacy

findings, emerging competition, alterations in the medical treatment paradigm, currency

fluctuations or changes in the pricing/reimbursement environment.