Dyax's (UNKNOWN:DYAX.DL) second quarter earnings call is this Wednesday, and there's plenty that investors interested in the company need to know. Here are the three most important questions I think management should answer during the call, ranked in order of increasing importance.
3. How's Kalbitor selling, and what is management doing to grow sales?
One of the things that I like best about Dyax is that it's not a wholly clinical stage company. Kalbitor -- Dyax's single approved drug designed to fight hereditary angioedema (HAE) attacks -- isn't a big seller, but every little bit helps. Management has previously guided for Kalbitor to bring in between $60 million and $70 million in revenue this year. Given that we're at the halfway point for 2015, it'll be good to know if Kalbitor -- which sold $16 million last quarter -- is still maintaining that run rate. If Dyax discovers certain particularly effective tactics to unlock Kalbitor's revenue potential, those will hopefully also be of use if its experimental drug DX-2930 comes to market. Since both drugs would be indicated for treating HAE, Kalbitor's marketing could be a nice opportunity for management to build out the necessary expertise to effectively monetize DX-2930.
2. Are there plans to further expand the Licensing and Funded Research Portfolio (LFRP)?
Dyax has 11 drugs in clinical trials in its LFRP, all of which are licensed out to another company in exchange for milestones and potential royalties. And Dyax isn't playing around -- its partners include big names like Biogen and Eli Lilly. Management has guided for the LFRP to bring in between $7 million and $9 million in fees this year, exclusive of royalties. Eli Lilly's cancer drug Cyramza is the one drug in Dyax's LFRP that has commercialized, so Dyax received $3.4 million in royalties last quarter. Keep an eye out for more about management's strategy to expand and further monetize this portfolio. Does that mean more drugs heading into the clinic? More partners? Both? While the LFRP doesn't bring in the revenue of Kalbitor, I see a lot more upside in this diverse group of drugs, and investors should look forward to hearing more on it from management.
1. What's DX-2930's timeline?
Dyax trumpeted DX-2930's phase 1b data in a special call in March. And there was lots for management to be excited about. The drug, which is designed to prevent HAE attacks, succeeded in doing just that in two arms of the trial. Patients given 300 mg and 400 mg doses saw 100% and 88% declines in HAE attacks compared to placebo, respectively, during the 6-week primary efficacy interval. Although the trial was small (37 people, to be precise), it was excellent to see such substantial -- and statistically significant -- responses.
On the call announcing DX-2930's phase 1b results, Chief Medical Officer Burt Adelman noted that management plans to "sit down with the FDA and try to figure out based upon what we believe our strong proof of concept and dose response data what the minimum pathway forward to approval is." We'll want to know if those conversations have begun -- and if so, what the timeline for the drug looks like from here. Stay tuned, because that information will help us better understand how soon the drug could potentially come to market -- and how much cash burn investors will have to endure between now and then.
Early days yet
Dyax is still early in its potential growth cycle. After all, if DX-2930 makes it to market, analysts estimate peak sales of around $400 million or $500 million, easily outstripping Kalbitor. Hopefully this quarter's earnings call will give us better clarity into what the growth ramp looks like across the company's entire drug portfolio.