There’s at least one good thing to say about Iovance Biotherapeutics(NASDAQ: IOVA), a small-cap biotech. The drugmaker is an innovative company. It developed Amtagvi, a medicine that became the first of its kind approved for advanced melanoma (skin cancer).
However, this breakthrough hasn’t led to solid performances. Since Amtagvi’s launch last year, Iovance Biotherapeutics’ stock has been southbound. Even so, with an average price target of $9.10, which implies a potential upside of 261% from its current levels, Wall Street continues to have faith in the company. Should investors consider buying Iovance Biotherapeutics’ shares?
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The process involved in manufacturing and administering Amtagvi is complex. It requires physicians to collect a piece of the patients’ tumors from which they extract T cells (which, among other things, help fight cancer) to grow in a lab. From that, patient-specific infusions of Amtagvi are manufactured in a specialized facility. Before receiving Amtagvi, patients have to undergo chemotherapy. The entire process typically takes over a month.
There are also significant expenses associated with the medicine that wouldn’t exist if Amtagvi were an oral pill. All these factors have made it challenging for Iovance Biotherapeutics. Earlier this year, the company revised its guidance after realizing it had been too optimistic with its estimates of activating authorized treatment centers where Amtagvi can be administered to patients.
Still, Amtagvi is generating decent sales. In the second quarter, Iovance Biotherapeutics reported revenue of about $60 million, almost double what it reported in the year-ago period. Most of that was from Amtagvi. The company’s other commercialized product, Proleukin, another cancer medicine, generates relatively little revenue. For fiscal 2025, Iovance expects total product revenue of $250 million to $300 million. Again, most of that will be from Amtagvi. That’s not bad for a medicine that was only approved last year.
Those bullish on the stock might point out several things. First, Amtagvi could earn approval in other regions within the next 12 months, including Canada and Europe. That would significantly expand Iovance Biotherapeutics’ addressable market. Considering the medicine could generate upward of $200 million in the U.S. the year after approval, the global opportunities look attractive.
Second, even in the U.S., Iovance has barely scratched the surface of the patient population it is targeting. Amtagvi is indicated for melanoma patients who have undergone some prior therapies unsuccessfully. In the U.S., 8,000 patients die from the disease every year. Even if not all of them would be eligible for Amtagvi, it is certainly a lot more than the just over 100 Iovance has treated so far.
Third, Amtagvi could earn important label expansions down the line. The medicine is being investigated across a range of other indications, including lung, endometrial, and cervical cancer. If it can score phase 3 clinical wins, that could expand the therapy’s target market and jolt Iovance Biotherapeutics’ stock price.
However, even with all that, the biotech remains a risky bet. The complex and expensive nature of the medicine it develops and manufactures will make it challenging to gain significant traction while allowing it to turn a profit. Expanding into new territories will help Amtagvi’s sales, but it will also significantly increase its expenses.
Further, Iovance isn’t exactly cash-rich. The company ended the second quarter with about $307 million in cash, equivalents, and restricted cash, which it believes will enable it to last until the fourth quarter of next year. That’s not very long. Amtagvi-related sales and various financing options it could pursue should allow it to keep the lights on even longer, but it’s rarely a good sign when a company says that its cash will run out within a year and a half.
Finally, Iovance Biotherapeutics could encounter clinical and regulatory obstacles with Amtagvi, which could negatively impact its stock price. The biotech stock looks too risky for most investors. I don’t expect Iovance Biotherapeutics to hit its average Wall Street price target in the next 12 months.
But investors with a large appetite for risk might still want to consider initiating a small position in the stock. Given its innovative potential and the possibility that it will execute its plan flawlessly, its shares could skyrocket.
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Prosper Junior Bakiny has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Iovance Biotherapeutics. The Motley Fool has a disclosure policy.
