Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) Q4 2022 Earnings Call Transcript

Matt Sherman: Yes. Hi, Paul. It’s Matt. So yes, in regards to our plan to initiate a cohort of 3116 in combination with encorafenib and cetuximab, we’re obviously very excited overall with the preclinical data we’ve generated to date showing that we can inhibit multiple nodes along the RTK, RAS and MAP kinase pathway in combination with 3116 and show an additive or even a synergistic combination effect on tumor killing. So as we’ve initiated a number of these combination cohorts now looking at the unmet medical need in treating advanced-stage colorectal cancer and while cetuximab and encorafenib have activities demonstrated in the BEACON study a number of years ago, that was somewhat limited activity with an objective response rate of approximately 20% and the PFS of about 4 months. So they’re showing a lot of headroom for improvement in treating these patients and recognizing this might be a huge opportunity for 3116 and colorectal cancer.

Paul Jeng: Got it. Very helpful. Thanks so much.

Operator: Please stand by for our next question. Our next question comes from Tyler Van Buren with Cowen. Your line is now open.

Tyler Van Buren: Great, thank you. Good morning guys. I had a couple for you. The first is can you help us understand what the magnitude of the one-time reserve for QINLOCK sales in Germany was and elaborate more on your expectations for the cadence of ex-U.S. sales throughout the year? And the second is for vim in TGCT, you’ve presented an extensive claims analysis, but what other data points give you confidence in this market, given that patients are so diffused throughout the country and not necessarily concentrated in centers of excellence?

Steve Hoerter: Yes, good morning, Tyler. Thanks for the set of questions. I’ll ask Tucker to comment first on the reserve in Germany. Margarida, perhaps you can then comment on what you see as the cadence in terms of the commercial business across Europe. And then, Dan, why don’t you take the final question with respect to vimseltinib claims analysis and the confidence we have and the size of the opportunity. Tucker?

Tucker Kelly: Sure, Tyler. So we haven’t quantified the amount of the reserve in Germany that we took in the fourth quarter. But just to remind folks, what happened is that the German authorities in November changed the law. It used to be that you had a 12-month period of free pricing and that got shortened to six months effective retroactively based on the law change in November. So in the fourth quarter, we took a reserve based on the net sales that we had booked at our free pricing price in the third quarter. And then in the fourth quarter, the sales in Germany were booked at an estimate because we’re still not at our final price in Germany, but an estimate of where we think we may end up with the German authorities on pricing. So we haven’t quantified it, but it certainly was a larger number in the quarter that we wanted to make sure people understood that as they looked at the quarter-over-quarter change in international product sales.

Margarida Duarte: Okay. I will take the second one. Thanks, Tyler, for the question. So I would say that the cadence for the rest of the year in Europe will come from two key strategic drivers. The first one is to continue to successfully drive price and reimbursement in the countries where we don’t have yet access, so that we can launch in new markets in the future; And the second one, I would say, is to continue to successfully execute on our launch strategy and continue to raise awareness to drive demand and to expand the prescriber base. And I would also offer to and €“ say that I’m extremely pleased with the success that we are seeing so far and with the strong demand that we continue to see.