Gubra A/S (GUBRA) Earnings Call Transcript & Summary

[Operator Instructions] Now I will hand the conference over to the speaker. Please go ahead.

Thank you very much and welcome to this presentation of the news that Gubra could announce this morning. I'm Henrik Blou, I'm the CEO of Gubra. And with me here today, I have Louise Dalboge, our Chief Scientific Officer; and Kristian Borbos, our Chief Financial Officer. They will be able to help during the questions section. So what we announced today was a deal with AbbVie where we have our GUBamy amylin program, which is now partnered with AbbVie. So it's a transformative deal for Gubra and we really are very, very satisfied with what we have obtained here. So we see great potential for GUBamy. It's an amylin peptide discovered and developed by Gubra and now with a strong partner on board, we can unfold the potential of GUBamy. So really it can accelerate the development towards the market and we have with this deal now AbbVie, they are going into the obesity field. So it's a very strong partner. It was everything we dreamed of for this asset. We -- I'll just go to the next slide here. So what we have done today is that we have made an exclusive global license agreement to develop and commercialize GUBamy, our long-acting amylin analog. Hence it will be in the hands of AbbVie after closing of the transaction. Closing is subject to standard regulatory approvals and other customary closing conditions. And in this agreement, Gubra is eligible to a $350 million upfront. There's a milestone package up to $1.875 billion and tiered royalties on global net sales. So generally about GUBamy. The therapies in the overweight and obesity management market today are efficient, however, there are still room for improvement and alternatives are needed. GUBamy has the potential to be developed as a stand-alone therapy and also as part of a combination therapy. The molecule that we've developed is a balanced amylin so it's balanced on the receptors of amylin family and calcitonin. And by balanced, I mean that it resembles the native amylin when it comes to the receptor profile. We've developed a compound with a long half-life, 11 days, and that means that it's perfectly suited for once weekly dosing. As mentioned, there is potential both as a combination therapy and also as a stand-alone treatment. GUBamy has been developed to have excellent physical and chemical stability at neutral pH and also, we have a very long patent exclusivity. So with the various results that we have presented, it's in our opinion the best-in-class amylin that we have here. So previously we have announced results from the first clinical trial with GUBamy. It's an SAD trial, single ascending dose, and what we did see in that trial was that it's well tolerated, adverse events being predominantly GI-related, mild and transient. We saw, as mentioned, a favorable pharmacokinetic profile, 11 days half-life. And after just a single dose of GUBamy, we did see reduced body weight in a dose-dependent manner and the effect was sustained for the duration of the trials for 6 weeks. We did see in the higher doses that we could get to approximately a 3% body weight decrease in the high dose groups whereas the placebo group gained approximately 1%. So bear in mind, this was after a single dose of GUBamy and yes, in our opinion, very, very strong results. So that supported the further development of GUBamy. And we have an ongoing MAD, multiple ascending dose, Phase I trial and 2 first cohorts are what we call Part A where subjects are treated for 6 weeks with the same dose. There's also a Part B where subjects are treated for 12 weeks. There's a titration phase and a plateau phase and that part is currently ongoing. So that was a quick run through of the various aspects and this in our opinion very strong deal, which was exactly what we were hoping for. It's been our strategy from the beginning to keep relevant parties in the market informed of the data and whenever the right deal terms were on the table, we would strike a deal and that happened this morning when we were able to sign this agreement with AbbVie. In our opinion, the excellent partner to bring this forward at speed and with a significant development and commercial muscle. So with that, we will be opening up for questions. Moderator, please initiate.

[Operator Instructions] The next question comes from Thomas Bowers from SEB.

Congratulations on the deal. So firstly, just on the royalty levels, you don't say much about it. So can you maybe just give us some directional guidance here? Are we looking at some similar levels to what we've seen with other deals in the obesity and the MAD space here in the early clinical development stages? So give us any directional would be great. And then just in regards to the clinical data, how much have you provided to AbbVie? So I'm just curious whether they have seen any initial part of the MAD data ahead of this deal? And maybe a third question just could be -- I should address this to AbbVie. But what edge do you believe that GUBamy have compared to other amylin opportunities? There's also at least a few available out there for partnering. So is there an edge in the data? And any molecule that has made AbbVie more interested in GUBamy or is this maybe more from a financial perspective?

So to start out on the questions regarding royalties. So at Gubra, we see great potential of amy and therefore, it's been a key point for us to secure royalties in the agreement and we have secured that. We cannot comment on the level. It's tiered royalties on global net sales. And it was really important for us because we see a great potential when this comes to the market. And with a strong partner like AbbVie, a very solid engine for development and commercialization, we believe that the royalties to Gubra will be significant. For the second question, the clinical data and how much is shown. So as you would expect, there's been a very thorough due diligence from the AbbVie team and they have been looking into all aspects of this asset and the history of it. So the clinical data from the MAD study are still blinded and the data from the SAD part are unblinded and those we presented earlier. For the third question with regards to other amylin assets out there. As you mentioned, there are several amylins in development and I think interesting data has been coming out from the various programs, all supporting the very interesting biology with amylin when it comes to management of overweight and obese patients. So what we see in our data package is a very long half-life, we see a very nice effect on weight after just a single dose and sustained body weight reduction. So in our opinion, it's the best-in-class amylin, very, very strong data and I'm sure that has been part of the assessment from AbbVie and why they wanted to enter this agreement with Gubra.

And maybe if I just could follow up just on the interim data, MAD data here for April. Is this still something that we can expect or is the news flow now in the hands of AbbVie?

So right now there is some timing between signing and closing and in that period, we will be running the program as planned. After closing, it's a very close dialog with AbbVie, whatever changes, how to accelerate the program, the development and so on. So that's about as precise as I can get to the answer of that question as of now.

The next question comes from Martin Parkhoi from SEB.

We stay in SEB also. Yes, I also have a couple of questions. Firstly, I know it's very, very long term, but have you discussed supply and manufacturing commitment with AbbVie? Secondly, when is AbbVie set to take over the development, meaning that the cost for the partnership that you guided for Friday, does that hold or will AbbVie already take over some cost in '25? And then thirdly, of course when we look at the potential for GUBamy or what we should call it going forward, then there is both a potential in monotherapy, but also a potential in a combination therapy. This is the first product from AbbVie within obesity. Have you discussed with them that they will build a broader pipeline, which also means that they could do some combination potential as well and is that part of the deal?

So first of all with regards to supply and manufacturing, that's a key thing we know in the obesity market. It's a high volume market and that is one of the reasons why it's been important for Gubra to select a very strong player with a very strong muscle, financial muscle so that it's being taken forward at speed through the development phases and also with regards to all the other aspects that needs to be in place in order to have a strong commercial launch. So we have a -- that's a key reason for us to select a partner like AbbVie that they have a strong muscle because it takes a strong muscle to go into the obesity space. With regards to costs this year, we -- now it's all about getting this developed at speed and naturally AbbVie will be able to develop this faster than Gubra would be able to and really it's for the 2 parties now to collaborate in the best way to ensure it gets developed as fast as possible. So it means that AbbVie will conduct most activities going forward, but of course there is a phase where we are completing and/or transferring some of these activities to AbbVie. So we signed this morning and we will have further clarity later on. I guess this is for after closure when really the transfer of activities and this program as such will be initiated from Gubra to AbbVie. With regards to the potential with mono and also combination, this is a key moment today, right, because a very big player AbbVie signals the clear intention to go into the obesity space and they do that not just to play, but to win, right? So GUBamy will be a key asset in their pipeline. And I think you should ask AbbVie with regards to their plans in general in the obesity space, but I think it would be natural for them to build a pipeline with several assets.

Just a follow-up on the potential milestones of almost USD 2 billion. I'm just trying to understand that will there already be milestones related to the outcome of the Phase I data we are seeing potentially in April and also on the Part B of that or is it -- are the package more back-end loaded?

Yes. So what we are disclosing today is that it's a milestone package including development, commercial and sales milestones. So I think you have to read into that language. Generally we don't guide on milestones and we cannot get into more specifics. But I think the milestone package as such is very attractive and it's of course one of the key reasons for Gubra to go into this partnership. We were after sort of terms in general that we think are very attractive so we have an upfront, which we believe is attractive. We have a milestone package, which we believe to be attractive. And then we also have the royalties, a key thing as we see great potential for this program. And then of course last, but not least, it was key for us to get a very strong player with significant muscle to go into this space. And I think we have obtained exactly what we were hoping for in all respects here.

Thank you very much and also a huge congratulation from my side.

The next question comes from Suzanne van Voorthuizen from BLK.

This is Suzanne from Kempen. Can you clarify what the rough time line is for closing of the deal? Second, we're curious to learn what you plan to do with the $350 million upfront, any thoughts you can share on this? And then looking beyond, can you remind us of the news flow that is next to come for the rest of the pipeline?

So with regards to timing of closing, it's I think some very standard procedures ahead of us, regulatory or approvals from various authorities. We see no significant risk here, but of course it's something that has to be done and it has to be done at whatever speed it takes. So we cannot really go into sort of a guesstimate for a date for the closing, but we are very confident on our side that we will get to a closing and that there should be no problems related to that. $350 million upfront, it's of course a nice new problem that we have. I think now it's all about celebrating for us here and the team. It's all about carrying on the activities towards closing. At that point in time, we will receive the upfront payment and we will be able to comment on our line of thinking there. So as you also mentioned here, we have a pipeline. I think we have a very interesting pipeline. Already on Friday, we signaled our great belief in the pipeline. And for example the next program in line, our UCN2 for high quality weight loss, and that is something that we are driving forward at speed and we are planning to take that into the clinic as the next pipeline program. But again I think financials like this, it shows the commitment of our new partner. It shows that we are able to build in significant value in our pipeline programs and it opens up for a range of possibilities and we have to assess that carefully now. With regards to news flow for the rest of the year from the pipeline, any comments from the rest of the team here.

No. I think the startup of the UCN2 clinical trial and the preparation for that, I think that's a very important next news flow for Gubra on the operational side. Then of course we also have a service business that is having great times. So there will also come some quarterly news on that front also.

That was Gubra's CFO, Kristian, answering that question.

The next question comes from Harry Gillis from Berenberg.

Just a quick one. We were wondering whether this was a competitive deal and you had other players involved in the process alongside AbbVie. And then perhaps could you just touch on a little bit more why AbbVie is such a strong partner for you? I know you discussed the strength of their commercial and development muscle, but perhaps anything on their scientific expertise given obesity is a relatively new area for them?

Yes. So we've been through a very thorough process. We have over a significant period of time produced data in the GUBamy program and we have ensured to keep a long range of potential partners updated on the progress. We have had several players that we took into more sort of lengthy discussions and eventually when we were able to negotiate the right terms here with AbbVie, we struck a deal and we did that this morning. So I think the fact that AbbVie now is going into obesity with this as their first asset is a very strong signal and it's a signal that there's a great belief in GUBamy as a centerpiece in an obesity pipeline going forward. When a company like AbbVie goes into a new area especially one like obesity, it's after careful considerations and it's a serious step for them. And the fact that GUBamy is not third or fourth obesity project in our pipeline, but it's the first and it will receive a great amount of attention and investments and muscle that it was a key element in our decision.

The next question comes from Charles Weston from RBC Europe Limited.

First of all, in terms of time lines for launch, I appreciate that you're expecting AbbVie to accelerate things. But sort of before you did the deal, what would have been your expectations for approval and launch timelines for GUBamy? Secondly, this is a subcutaneous product. Is there any interest from either party on making it oral? And lastly, just following on from one of the previous questions around the $350 million and you highlighted that you have plenty of investments to make in the existing pipeline. Is there now going to be more desire from the Board to take more clinical risk and take assets perhaps further through the development pathway before outlicensing?

Thank you for your questions. Time line towards launch, what we've communicated so far is that we have a Phase I trial ongoing. We have had a readout from SAD and there's an MAD part that would be ongoing, sort of the active part of it, throughout the year this year. So there are numerous ways of taking an asset forward. We've never sort of come in with an estimate for a launch date and, as mentioned previously, are clear. There are definitely possibilities now for AbbVie to develop this at speed towards the market. It's their clear intention. However, I won't start guessing on a potential launch date here. So it's been developed as a subcu program so far and it's -- there are no -- so the molecule as such is not designed for oral delivery. So you can speculate that you can, I don't know, combine with other technologies further down the line to change the route of administration. But generally this is a subcu product and the fastest way towards the market will be to develop it further as a subcu product. And with regards to the large upfront that's coming our way in the not-too-distant future, we communicated on Friday our strong belief in the current pipeline and that there are certain investments that we are looking into in that pipeline. I think the financials that we see now, I mean it clearly marks the value of this project as being a high value project. It also shows the commitment from our new partner. And it's such a significant size that it's opening up a range of opportunities and I won't at this point in time start speculating whether it will drive further investments than already communicated in the pipeline or not. I think that's still something that we should consider carefully together with our Board of Directors and so on. So I mean we signed the deal this morning and now it's time to celebrate and clearly there are a range of careful considerations to be made.

And can I just follow up on the royalty question right from the start. You said that you weren't going to be able to disclose what these were. But is there even a rough guide you can provide, low single digits, high single digits, that kind of broad area?

No, I cannot provide any further details here. I can just underscore that it was a key element for us in this agreement. We see a very strong commercial potential in GUBamy and of course Gubra should have a part in that and that we have now.

Thank you very much and congratulations.

[Operator Instructions] There are no more questions at this time. So I hand the conference back to the speakers for any closing comments.

Thank you very much for all the questions. Thank you very much for the very large interest that we have experienced today from a lot of players and people around Gubra. It's definitely a day of celebration. We have secured a very nice agreement on this key asset for Gubra and we are very pleased. So that was what we had for you, for now and thank you for listening in. Bye.