Release Date: August 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Omeros Corp (OMER, Financial) significantly reduced its outstanding 2026 notes by 55%, from $216 million to $98 million, through a favorable debt repurchase and exchange transaction.
- The company has $158.9 million in cash and investments as of June 30, 2024, providing a solid financial cushion.
- Omeros Corp (OMER) has multiple promising clinical programs, including the MASP-3 inhibitor zaltenibart, which has shown strong efficacy and safety profiles in Phase II studies.
- The company is preparing for the resubmission of its Biologics License Application (BLA) for narsoplimab in TA-TMA, with ongoing engagement with the FDA.
- Omeros Corp (OMER) has a $25 million delayed draw facility available, contingent on FDA approval of narsoplimab, providing additional financial flexibility for early commercialization efforts.
Negative Points
- Omeros Corp (OMER) reported a net loss of $56 million for Q2 2024, a significant increase from the $37.2 million net loss in Q1 2024.
- The company incurred $17.6 million in R&D expenses related to narsoplimab manufacturing, which contributed to the increased net loss.
- Interest expense for the second quarter was $9.2 million, higher than the first quarter due to increased interest expenses associated with the DRI transaction.
- The company faces ongoing uncertainty regarding the timing of FDA approval for narsoplimab, which is critical for future revenue generation.
- Omeros Corp (OMER) experienced a decrease in cash and investments by $71.4 million from March 31, 2024, primarily due to significant expenses related to narsoplimab manufacturing and debt repurchase.
Q & A Highlights
Q: The first one is on the quarter in terms of the expenses, can you give us any modeling or any idea as to how this expense that we modeled in basically would factor into the future?
A: Sure. I think -- I hope we were pretty clear, Steve, that those expenses that were -- the large expenses and charges and costs incurred in the second quarter were those that we don't expect to be repeated. There was a large manufacturing cost, there was a repurchase of the term loan related debt, $21.2 million, where, again, that was at 75% off par. So all of that got retired and then there were the term loan related transaction costs.
Q: For the purposes of future when you see approval, what else do you need now that you've got this manufacturing expense done? What else do you need to be able to go out there and when you will get approval, what else would you need to literally go into the markets?
A: Well, there's one rather large component that we would need, which would be FDA approval. And we're working hard to secure that. I mean when you look at the data, we think the data are very clear. And frankly, as I said, we have a meeting scheduled with FDA. Those were part of the prepared comments. And we believe we're in very good shape with respect to the data and the case for its approval. So we just need to play this out a bit. But that's really what we need in the U.S. We're also pursuing, as you know, EMA approval for narsoplimab.
Q: Can you tell us when that additional meeting with the FDA is expected to happen? And whether there's any new information or data that they passed for ahead of that meeting?
A: We won't specify the date of the meeting and the information is, as you might expect, it's information on our programs and responses to FDA questions.
Q: On 906, I just wanted to clarify that you guys do have the monotherapy data in-house? And if so, can you give us a sense for just level of confidence around that program? And anything you can tell us at this point on the Phase III design, both for PNH but also C3G?
A: First, I'll talk about the monotherapy data. Unfortunately, we can't give you any specific details on that data because, as Greg said, that's been submitted to an ASH abstract and it's embargoed until ASH publishes that, which will come later in the year. The data is strong, we're feeling positive about everything we're seeing, both in that adjunctive switch study as well as the data we've already presented in the naive study. And Greg also mentioned that we've amended that protocol to develop data to help with dose selection.
Q: Regarding zaltenibart and the C3G program. You're currently still enrolling patients for the Phase II study. Do you have any timeline set to complete that study ahead of the potential launch in the first quarter of next year, whether or not there could be any potential overlap between Phase II and Phase III during that time?
A: We think that we will have data from the C3G Phase II study later this year or early next. And also, as I noted, we're planning to initiate the Phase III program early in 2025. I would actually anticipate having no overlap between Phase II and Phase III. The Phase II study has a [indiscernible]. And if you recall, I believe it was 7 patients that Novartis presented at an ASH meeting or an ERA meeting, so you can get a good sense of efficacy with small numbers of patients in an open-label study. So we would -- as soon as we gather the data to see a strong efficacy signal, we would start initiating Phase III activities immediately before we run the study out completely.
Q: Regarding OMS1029. You're expecting data in the third quarter of this year. How quickly do you think, pending good data, how quickly do you think you'd be able to get this into the clinic following the study?
A: If the data are as clear as we would hope, then I think we would get right to finalizing a clinical trial design. We would get the necessary input from key opinion leaders in the field to make sure that the trial design makes sense, and we'll deliver a clear answer. So I would expect us to move into the clinic sometime early in 2025.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
