FibroGen, Inc. (NASDAQ:FGEN) Q2 2023 Earnings Call Transcript

Operator: One moment for our next question. Our next question comes from the line of Jason Gerberry of Bank of America. Please proceed with your question.

Jason Gerberry: Hi guys, thanks for taking my question. Going back to the patent topic in China, is the process with the generic challengers entirely an issue of patent validity and if the patent is found valid, then there’s a barrier until the expiry of the crystalline form IP or is there potential avenue of those generic challengers have different non-infringing crystalline form molecules they can potentially have an avenue to be found non-infringing. Just wanted to understand that dynamic a little bit better. And then, on pamrev for ambulatory DMD, I am wondering, if you could highlight any important mechanistic differences why pamrev might be more effective here than say, the non-ambulatory setting. Thanks.

Thane Wettig: Thanks Jason. Chris, if you could take the first question?

Chris Chung : Absolutely. So with respect to generic challenges, so, first and foremost our competition matter patent is valid and all generic applicants on the patent linkage system in China have declared that they respect those patents. So that is a fact and this is why we’re very confident that there will be no generic on the market until after that expiry. With respect to the crystalline patents. Crystalline patents are not considered part of the patent linkage system, which means they’re not enforceable by the Health Authority, but they are enforceable by the court of law and that is what we will have to pursue. As to whether a generic applicant could potentially have a crystalline form and alternative polymorph patent that could get around us that unfortunately I think it’s a question we have to defer to the patent attorneys to answer. I hope that’s helpful.

Thane Wettig: No, that the other question was around the ambulatory versus non-ambulatory DMD. And I think we’ve always said that we expect a non-ambulatory DMD to be the most challenging because the patients have already lost so much function and they wheelchair-bound and the signal-to-noise ratio of the endpoint, the performance of the upper limb. We expect it to be a challenge and turned out to be a challenge. We also didn’t see any clinically meaningful efficacy, in terms of the other endpoints including FPC percent predicted, ejection fraction by cardiac MRI. Unfortunately and it was very sad for all of us at FibroGen because we’re really hoping to be able to deliver a therapy for these patients with non-ambulatory DMD, which is so desperately needed.

So now we turn our attention to ambulatory DMD where because these are younger patients, they already – they still have much more functions. I think the North Star Ambulatory Assessment is a more holistic type of endpoint. We do feel like we still have a possibility of showing a benefit in this patient population and we’re really looking forward to those top-line results in the near future.

Jason Gerberry: Yes. Thank you.

Operator: One moment for our next question. Our next question comes from the line of Annabel Samimy of Stifel. Please proceed with your question.

Annabel Samimy : Hi. Thanks for taking my questions. Just while we’re on the DMV topic, I guess, one of the things we’re wondering is, if in the ambulatory GM D trial, you don’t necessarily see function, but you see benefit on some of these other markers such as the injection fraction or FEC. Do you see an avenue for filing on that? And in the non-ambulatory understanding that the non-ambulatory is more challenging, but with FEC and injection fraction or they is it also more challenging on those measures as well or with a strictly on the functional endpoints that you are referring to? Thank you.