With shares of Bluebird Bio (BLUE -0.29%) down nearly 43% so far in 2022, it's reasonable to think that the gene therapy maverick is looking a bit worse for the wear. The past couple of years saw it retreating from the EU market, facing questions from regulators about the safety of its therapies, and confronting concerns about its solvency moving forward by doing extensive layoffs.

Nonetheless, a couple of major new developments could point toward a turnaround in progress. And that means there could be an opportunity for brave investors to buy the dip. However, let's analyze the situation before you go rushing to invest, as it's quite a risky proposition. 

Why buying a few shares could be a good choice

There are two big reasons supporting a purchase of Bluebird stock. In the last couple of months, it got the green light to commercialize two of its gene therapies in the U.S., Skysona and Zynteglo. Skysona treats cerebral adrenoleukodystrophy (CALD), a rare and ultimately fatal neurodegenerative disease that impacts young boys, and Zynteglo treats beta thalassemia, a hereditary blood disorder.

Analysts estimate, on average, that sales of the two medicines will bring in around $79.2 million next year.​​ And that's quite a bit more than the company's trailing 12-month revenue of just over $6 million. So it's reasonable to expect a high rate of revenue growth in the short term.

Pricing and profitability may continue to be bugbears

The trouble with Bluebird is that commercializing new medicines doesn't accomplish much for shareholders if the medicines are too difficult for patients to access. There are a pair of constraints suggesting that might be the case, starting with Zynteglo's price point of $2.8 million for the single (potentially near-curative) dose of the treatment. Skysona's price tag is even higher, at $3 million, and it isn't expected to be curative, only to slow the progression of CALD.

The company claims that those prices are lower than the cost of a lifetime of treatment, which for beta thalassemia is around $6.4 million, at least according to the investor materials. It also claims that it'll offer an 80% refund if Zynteglo doesn't actually live up to its promise after two years, and that it's working with public and private insurers to guarantee that its medicines are covered.

If the terms of coverage leave patients on the hook for a significant sum, it'll be a fierce headwind to revenue growth, to say the least. And that's exactly what happened when it tried to compete in the EU with Zynteglo, leading it to a sheepish exit from the market in August 2021.

The second constraint is the therapy manufacturing process, which is not simple. Bluebird needs to operate qualified treatment centers to administer the therapies. It's building a network of them nationwide by linking up with clinics that already treat patients with the disorders. That's important because Zynteglo is produced from a sample of a patient's cells, which need to be harvested, shipped to a manufacturing site, processed appropriately, and then returned to the treatment center in short order for infusion into the patient. That entire process is likely to be quite expensive, not to mention difficult to scale up.

Finally, aside from the issues with the pricing of its therapies, the biotech's pipeline looks a bit thin. It has one late-stage program for sickle cell disease, and a pair of earlier-stage programs for the same indication. It should be submitting its approval application to regulators for the most mature of those programs as soon as Q1 of next year.

Still, if there's a delay in the approval process and a competitor like CRISPR Therapeutics beats it to the punch with commercializing a gene therapy for sickle cell disease, it's hard to see how its pipeline has much in the way of fuel for future top-line growth. That's an unlikely outcome, but it's still a risk.

Wait for confirmation of the therapy model's profitability

Given the above, it's quite risky to buy the dip with Bluebird Bio. Even if you're accustomed to the level of risk involved with biotech stocks, there are still probably better options out there. The company could perform very well in the short term due to its rising therapy sales, if not necessarily the long term, when profitability could be a concerning factor.

But for most investors, it's best to steer clear until Bluebird can show that its therapies can be sold at a profit. Pay attention to its earnings reports in 2023 to see.