This Stock Is Up 74% This Year: Is It Too Late to Buy?

After several years of underperforming the market, Iovance Biotherapeutics (IOVA 1.61%) is finally bouncing back. The biotech company's shares have soared 74% this year. However, the stock still looks pretty cheap -- it is trading for just under $5 apiece. And for what it's worth, several Wall Street analysts think it could rise even more. Its average price target (according to Yahoo! Finance) is $8.80. Should investors rush to buy the company's shares?

Image source: The Motley Fool.

A high-risk, high-reward play

Iovance Biotherapeutics developed Amtagvi, an approved medicine for treating melanoma. Amtagvi is manufactured from patients' own cancer-fighting cells, which are harvested, grown in a lab, and then reinserted back into the patient. Amtagvi's sales are growing at a good clip. In the first quarter, Iovance Biotherapeutics' revenue (mostly from this product) increased 45% year over year to $71.4 million. Meanwhile, Iovance Biotherapeutics is making progress in regions outside the U.S. It earned approval for Amtagvi in Canada last year, and could see the medicine's sales improve meaningfully as it ramps up commercial efforts in the country.

Further, Iovance Biotherapeutics could obtain approval for Amtagvi in several other countries, including across the European Union. Launching the medicine in these regions would significantly expand its addressable opportunity, likely even more so than the Canadian market. Elsewhere, the company is making clinical progress. Iovance Biotherapeutics is developing Amtagvi for the treatment of endometrial cancer. The company also boasts several other pipeline candidates. Provided the biotech company can earn significant clinical wins over the next few years while also making solid commercial progress with Amtagvi, it could maintain the momentum it has had so far this year.

Expand

NASDAQ: IOVA

Iovance Biotherapeutics

Today's Change

(-1.61%) $-0.07

Current Price

$4.28

Key Data Points

Market Cap

$1.9BMarket cap calculated using publicly traded shares outstanding only. Does not include unlisted, private, or dual-class non-traded shares. Implied market cap may vary.Market cap calculated using publicly traded shares outstanding only. Does not include unlisted, private, or dual-class non-traded shares. Implied market cap may vary.

Day's Range

$4.19 - $4.48

52wk Range

$1.70 - $5.63

Volume

10.3M

Avg Vol

15.1M

Gross Margin

25.04%

However, several factors could derail Iovance Biotherapeutics' plans, including the very real risk of clinical or regulatory setbacks every drugmaker faces. It has already encountered several. For instance, Iovance Biotherapeutics announced earlier this year that it was withdrawing its regulatory application for Amtagvi in the United Kingdom due to "procedural reasons," although it said it would resubmit it promptly. Beyond potential regulatory roadblocks, there is a much bigger issue with the Company. The medicines it develops are complex to manufacture and administer.

It takes about a month for Amtagvi to be manufactured after patients' cells have been harvested. And before receiving treatment, they have to undergo chemotherapy. Can Iovance Biotherapeutics eventually turn a profit, given that its therapies are so complex and expensive to administer? It's not clear that it can, and the company's bull case depends on a lot of things going right. Iovance Biotherapeutics may maintain its momentum if it continues to post strong financial results while eventually earning new approvals and label expansions. But the company is trading at a low price for a reason, and it could fall much further if it faces headwinds. So, Iovance Biotherapeutics is fairly risky, and only investors comfortable with volatility should consider initiating a position.