Our commercial team is focused on making this new standard of care outlined in all the medical guidelines the new standard of practice for health care professionals.
Allison Wey: Thanks, John. In addition, can we expect any material updates on the sales progression of Ogluo in the European market and timing of any associated milestone received?
John Shannon: Well, first, Ogluo is doing fine in Europe. In the near term, we don’t expect any material updates regarding Ogluo and we don’t have any near-term expectations regarding milestones.
Allison Wey: Thanks. Considering the pronounced prevalence of diabetes in specific international markets such as Mexico, could the team shed some light on the market entry strategy for Gvoke?
John Shannon: So we’ve evaluated all the larger markets outside the U.S. And with the exception of our partnership in Europe, based on the market opportunity assessment, financial analysis, the economics simply don’t work for Xeris. And therefore, we don’t have any plans to launch Gvoke in any other major markets.
Allison Wey: Thanks, John. Any updates on the Keveyis patent? Paul, do you want to take that?
Paul Edick: Yes. There — as I’ve mentioned it a couple of times in our previous calls, we have continued to go through the appeal process. We’re now in the process of filing our appeal with the Federal Circuit Court and that we’ll update as we have future events.
Allison Wey: Thanks. Are there plans to add more to the development pipeline other than levothyroxine in the coming quarters?
Paul Edick: We’ve said we’re going to be very disciplined about how we approach our pipeline and how we use our technologies for our own portfolio. Right now, levothyroxine once-weekly sub-Q injection is our focus. It’s the best opportunity that we have. That said, down the road, as we are able from an allocation of resources perspective, we will continue to use our technologies to develop new products that we can bring into our pipeline and eventually into our portfolio. Right now, the focus is levothyroxine.
Allison Wey: Thanks, Paul. Moving on to our XeriJect technology and the current and potential partnerships. So please provide a comprehensive update on the strategic trajectory with Regeneron, Amgen-Horizon, outlining anticipated timelines and potential inflection points expected by year end 2023.
Paul Edick: This is a great question and I think people are going to hate the answer. The projects and partnerships that we have with both Amgen Horizon and Regeneron are highly confidential. We’re working on other people’s molecules and other people’s products with our formulation technology and there’s very little that we’re able to say publicly. What I can say is Amgen-Horizon has gone quite well. We hit the target product profile. We got our payment and now we’re waiting on their decision whether they want to pick up the license for further development. I think that’s a great outcome. The Horizon, I’ve said previously, we’re in the process of formulating the initial products. They could continue to add products from the platform.
And they can — at any time and they can pick up a license at any point in time for continued development as well. So we’re very pleased with where those partnerships are at this point. I will add that they do take time. I mean the formulation process is not something that happens overnight.
Allison Wey: Thanks, Paul. So what are the competitive advantages of the XeriJect platform relative to other providers of the subcutaneous injection process? John, do you want to take that?
John Shannon: Sure. So with our XeriJect platform, we can reach ultra-high concentrated sub-Q injections. So what does that mean? Our XeriJect technology allows us to formulate 400 to 600 milligrams per milliliter in a sub-Q delivery that can be administered in a 15- to 30-second injection through a very small gauge needle. This is in comparison to other technologies and might deliver a 1- to 7-minute sub-Q infusion. Our Xeriject technology allows us to formulate drugs that are traditionally IV administration and potentially moving them out of the infusion center or doctor’s office into a self-administration form, potentially even at home.
Allison Wey: That’s great. So, John, can you talk to how your team identifies potential medicines like TEPEZZA or potential partners that could benefit from having a XeriJect formulation on their molecule?
John Shannon: Well, yes, I think it just covered the value proposition of XeriJect. So the ideal candidate today is a drug that is currently IV administered in an infusion center or a doctor’s office and could benefit from becoming a sub-Q administration, potentially at home. So when talking to companies, we focus on those types of products as true partnering opportunities.
Allison Wey: Right, thanks. So Paul, how long does it take to determine if the technology platform is a good fit?
Paul Edick: Yes. Each partnership is different and we go through several months of formulation refinement to work to achieve a desired target product profile. As John was going through, the identification of a target is immediately a fit. We’ve not failed to formulate anything that we’ve attempted to or been given by a potential partner to formulate. At the end of the day, getting to whether or not that is a viable asset takes several rounds of formulation and hundreds of rounds of optimization of that formulation.
Allison Wey: So then why has no one moved forward with a license yet?
