ImmunoGen, Inc. Pushes Its Pipeline Forward

ImmunoGen (IMGN +0.00%) reported results from its first fiscal quarter on Tuesday, but there wasn't much to talk about on the financial side. Sales of Kadcyla, the first drug the biotech helped develop, aren't particularly material after ImmunoGen sold the rights to royalties on the drug last year. The most important aspect of the earnings conference call is, once again, ImmunoGen's pipeline.

ImmunoGen results: The raw numbers

Data source: Company press release.

What happened with ImmunoGen this quarter?

• The biotech produced revenue -- $14.9 million in its first fiscal quarter, compared to $13.2 million in the year-ago quarter -- but the number is fairly meaningless since it includes milestone payments and non-cash royalties from Kadcyla. Likewise, the earnings line isn't useful for determining ImmunoGen's future; the company lost $33.7 million, or $0.39 per share, compared to a loss of $22.3 million, or $0.26 per share, for the same quarter last year.
• The most important numbers -- the ones highlighted in the table above -- are the amount of cash ImmunoGen is burning and the amount it has remaining. The cash usage has gone up substantially from the third quarter of last year to this year, but that's to be expected as the biotech pushes more drugs into larger clinical trials. Fortunately, the sale of its royalty stream on Kadcyla also netted ImmunoGen plenty of cash. It's sitting on twice as much as it was this time last year. ImmunoGen expects to have between $165 million and $170 million in cash at the end of its fiscal year in June 2016.
• On the pipeline front, mirvetuximab soravtansine, arguably ImmunoGen's most important drug, is about to start a phase 2 trial, called Forward I, in ovarian cancer patients who have failed three to four previous treatments. Given the unmet need, the trial could be the basis for FDA approval with just a phase 2 trial.
• ImmunoGen is also planning on starting a phase 2 trial called Forward II, which will test patients earlier in their disease progression. Mirvetuximab soravtansine will be combined individually with Roche's Avastin, Johnson & Johnson's (JNJ +0.12%) Doxil, and carboplatin to see which combination works best. By combining the drugs that are already used to treat ovarian cancer, ImmunoGen doesn't have to worry about competing with them. Since carboplatin is available as a generic, it might be the best option because it would keep the price of the combination therapy down -- or allow ImmunoGen to charge more. On the other hand, if the drug works well with Avastin or Doxil, ImmunoGen might be able to strike a deal with Roche or Johnson & Johnson to get them to pay for some of the clinical trial cost.

What management had to say 
ImmunoGen's president and CEO, Dan Junius, is excited about the potential for mirvetuximab soravtansine to get a quick approval. According to him, "We are planning to meet with the FDA about an accelerated pathway for mirvetuximab in ovarian cancer in the first half of 2016 and to report findings for the full 40 patient dataset at ASCO next year." As previously mentioned, the company isn't waiting for the FDA meeting to push ahead with Forward I, a clinical trial that could be the basis for approval, which is scheduled to start by the end of this year.

While mirvetuximab is likely to be ImmunoGen's next drug approved, Junius pointed out that the company is still pushing drugs out of the laboratory and into the clinic. He said, "We've submitted the IND for IMGN 779 product candidate. This is the fourth IND in four years ahead of our goal of submitting an IND for new product candidates every 18 months." IND is short for Investigational New Drug, an application that's required before the FDA signs off on clinical trials for the drug.

Looking forward
ImmunoGen remains a multiyear story. The solid data we've seen from mirvetuximab soravtansine makes for a clear path forward, but it's undoubtedly a long one.