This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
Operator
Greetings and welcome to the Catalyst Pharmaceuticals second quarter 2024 financial results conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, the conference is being recorded. It is now my pleasure to introduce your host, Michael Kahl, CFO. Thank you, Michael. You may begin.
Michael Kahl
Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's second quarter 2024 financial results and business highlights. Richard Daley, President and CEO, will lead the call today, and Jeffrey Del Carmen, our Chief Commercial Officer, and I will also present. Additionally, Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, will be available for the Q&A. Before we begin, I would like to remind you that in our remarks this morning and in the Q&A session, we will make statements about expected future results, which may be forward-looking statements for purposes of federal securities laws. These statements relate to our current expectations, estimates, and projections and do not guarantee future performance. They involve risks, uncertainties, and assumptions that are difficult to predict and may not prove to be accurate. Actual results may vary from the expectations contained in our forward-looking statements. These forward-looking statements should be considered only in conjunction with the detailed information contained in our SEC filings, including the risk factors described in our 2023 Annual Report on Form 10-K filed with the SEC on February 28, 2024, and in our second quarter 2024 quarterly report on Form 10-Q, which was filed yesterday, August 7, 2024, with the SEC. At this time, I'll turn the call over to Rich.
Stephen Miller
Thanks, Mike, and thank you all for joining today's call. Today we'll review our second quarter 2024 corporate performance, provide an update on our regulatory and strategic growth initiatives, dive deeper into individual product performance, and conclude with a comprehensive overview of our financial results. In the second quarter of 2024, we achieved outstanding results across our commercial portfolio with total revenues of $122.7 million, a 23.2% increase over quarter two, 2023, underscored by a record organic revenue growth from Ferdaps. The successful ongoing commercialization of Agamri for Duchenne's muscular dystrophy and the continued solid performance of FICOMPA. We are reiterating our full-year 2024 net product guidance for both FerdApps and FICOMPA. Agamri continues to deliver strong performance, and we are updating our Agamri full-year 2024 net product revenue guidance from the $25 to $30 million range we provided earlier this year to $35 to $40 million. As a result of our strong performance, we are also updating our full-year 2024 total revenue financial guidance. Previously, we guided to a full-year total revenue range of between $455 to $475 million. Due to the solid performance of both FirdApps and FICOMPA and the outstanding uptake of Agamri, we now believe that we will achieve total revenue at the upper end of the range. Jeff will provide further details about our commercial performance during this discussion, and Mike will give a deeper dive into the financials later in this call. Now let's review our regulatory, clinical, and business development milestones. First up, regulatory. In May, we received U.S. approval for Ferdaps' expanded maximum daily dose of 100 milligrams for treating LEMS, up from the previous 80 milligrams. This milestone enhances treatment flexibility for healthcare professionals, aligning with our mission to address the evolving patient needs and optimize outcomes for the limited patient community. As awareness of this new dosing option grows among patients and physicians, we anticipate a gradual increase in FredApps daily dosing over the coming quarters. In parallel, we continue to actively collaborate with our partner in Japan, Dido Pharma, as we await the next regulatory milestones for FERDAPs, the NDA decision from Japanese regulatory authorities, which is expected at the end of Q3 or the beginning of Q4 this year. In clinical, the summit study, a five-year initiative to collect long-term safety and quality of life data for GAMRI continues to advance. The study, once initiated, will gather long-term patient safety and quality of life data, offering a deeper understanding of the product's potential benefit for patients. Site identification and initiation are on track. Annual analyses of patient data is planned, potentially leading to future FDA submissions for updated product labeling, furthering our commitment to enhancing patient care and providing the latest safety information. Moving to business development, subsequent to the end of Q2 in July 2024, we entered into a license agreement with CHI Pharma for them to commercialize Agamri in Canada. As you know, CHI already holds commercial rights for Ferdaps in Canada. CHI expects to submit an application to Health Canada for regulatory approval of Agamri in early 2025. Our growing partnership with CHI is a great example of our commitment to improving access for patients in targeted ex-US markets. In our efforts to build our portfolio, we hear consistent feedback from potential partners. First, our strong commercial execution across a diverse portfolio makes us an excellent partner for companies looking for a US partner. Second, our launch capabilities engender trust with potential partners and are an attractive selling point. Third, our strong balance sheet makes us a formidable negotiator in acquiring new assets. Our strategy remains focused on delivering value for our stakeholders by continuing to execute our buy and build plan. With the ongoing commercialization of Agamri, we continue to prove our capabilities in identifying, integrating, and launching products that deliver value for patients, providers, and payers. We are confident in our ability to leverage the focused execution of our strategic initiatives while maintaining our commitment to advancing patient care, unlocking growth potential, and delivering value for stakeholders. Underpinned by exemplary track record and dedicated team, we believe that we are ideally positioned to drive further growth and achieve sustained success. To summarize, we remain focused on our threefold growth strategy, outstanding execution, portfolio diversification, and ex-US expansion through partnerships. First, let's focus on outstanding execution. Our consistent performance continues to demonstrate our commitment to improving the lives of patients we serve and delivering on the promise of growing the company. Second, portfolio diversification. Our expanded focus in orphan therapeutics and adjacent orphan assets has yielded increased opportunities, and our team is rigorously evaluating each for fit and value. We continue in our tireless efforts to bring on new products, and we are excited about our prospects. We remain opportunistic in pursuing the right deals at the right time, and we are well-positioned to leverage our strong balance sheet to capitalize on accretive or near-accretive opportunities. Third, targeted ex-US partnerships. We are building alliances with companies that can leverage our portfolio outside the US in high-value markets to bring improved care options to patients and providers. As we add to our portfolio, we expect to build our global presence through these cost-effective partnerships. In the second quarter, we successfully navigated an increasingly dynamic business environment, delivered on our top line across the portfolio, successfully drove the commercialization of the GAMRI, and expanded our commercial footprint. We will continue to work for the remainder of the year to deliver on our strategy, executing and delivering our plan, diversifying our portfolio, and expanding our ex-US partnerships. Now I'll turn the call to Jeff, who will provide a commercial update.
Jeff
Thanks, Rich, and good morning, everyone. We are incredibly pleased to report the tremendous quarterly performance across our entire commercial portfolio. These results showcase our strategic focus and operational excellence that drive our commercial success. As Rich mentioned, Catalyst had an excellent Q2, driven by the combination of sustained organic growth of Ferdaps, stable revenues from FICOMPA, and the strong commercial launch of Agamri. Q2 total net revenues of $122.7 million, a 23.2% growth versus the same quarter last year, positions Catalyst well to achieve the upper end of our previously provided combined 2024 total revenue guidance of between $455 million to $475 million. I will now provide a breakdown of Q2 net revenues by product. Let me start with Ferdap's performance. Q2 net sales of 77.4 million represent a 19.2% increase over the same quarter last year, a direct result of steady new patient enrollments, an annual discontinuation rate below the forecasted 20%, and a high refill rate. Net new patients in Q2 were above our forecast in the highest quarterly total since Q1 2022. Prescription approval rates were greater than 90% across all payers, government or private commercial insurers. Ordering patterns and refill rates of 95% in Q2 were greater than historical norms of 90%. We expect to return to 90% refill rates in Q3 and Q4 and the resulting 15% or greater growth quarter versus the same quarter in 2023. We remain confident in achieving FERDAP's full year 2024 guidance of between 295 million and 310 million. Our demonstrated strategic growth initiatives continue to drive organic growth. We maintain a pipeline of about 500 diagnosed LEMS patients in various stages of their diagnostic journey, not yet on Ferdaps. Half of our new patient enrollments typically come from this group, a prime reason for our ability to consistently deliver 15 to 20% annual growth. Furthermore, LEMS education programs targeting healthcare providers and potential LEMS patients continue to yield a high level of voltage-gated calcium channel antibody testing shortening the diagnostic journey for LEMS patients and leading to more patients being eligible for treatment with Ferdaps. Lastly, as we have mentioned before, more than 90% of small cell lung cancer LEMS patients are undiagnosed. Therefore, we are working with key thoracic oncology institutions to institute screening for newly diagnosed small cell lung cancer patients resulting in a greater diagnosis of small cell lung cancer in LEMS patients. Now let me provide an update on FICOMPA. Q2 net revenues of $36.5 million further fortifies our revenue diversification. We expect continued stable net revenues in the second half of 2024, in line with the full year 2024 net revenue guidance of between 130 million and 135 million. As I mentioned last quarter, epilepsy regional account managers are enhancing Ferdaps' share of voice by conducting secondary Ferdaps calls with healthcare providers. This strategy leverages the 45% overlap in physician call points between Ficompa and Ferdaps, boosting Ferdaps' visibility. We have seen early indicators that this tactic is working as several patient enrollments have been a direct result of this initiative. Let's shift our focus to a gamut. Q2 product net revenues were 8.7 million. Thanks to our dedicated efforts leading up to the March 13th, 2024 product launch, we successfully exceeded our initial launch expectations. Thus far, 46% of new enrollments are transitions from Enflaza while 42% are switches from prednisone, which we believe is a positive sign for the acceptance of a gamma ray. In addition, approximately 80% of the top MD centers of excellence and greater than 140 healthcare providers have submitted at least one gamma ray enrollment form. Around 89% of our current patients are reimbursed patients and average less than 30 days to approval. We expect the time to approval to decrease as payers finalize their policies over the next couple months. Based on the promising demand trend and encouraging payer landscape, we are revising our Montgomery full year 2024 guidance to between 35 million and 40 million of net product revenue. In summary, we are confident in our ability to continue the significant strides we are making with FERDFs reflecting our commitment to sustained organic growth. We continue to achieve stable net revenues with Vicompa and are surpassing our revenue projections for Agamri. Our emphasis remains on maintaining excellence in commercial execution while strategically leveraging our capabilities to optimize our performance. I want to thank the entire team at Catalyst for their unwavering commitment to patients, and look forward to a successful second half of 2020. I will now turn the call back over to Mike.
Michael Kahl
Thanks, Jeff. Our performance during the second quarter of 2024 has set us on pace for another strong year, driven by our solid financial performance and strong execution. With the successful launch of Agamri in mid-March, along with the continued performance of Firdabs and FICOMPA, we have established the foundation to achieve another revenue record-breaking year in 2024. As you heard from Jeff, we had an outstanding quarter in product revenue performance. In the second quarter of 2024, net income before income taxes was $55.8 million, a 15% increase compared to $48.5 million for the second quarter of 2023. We reported gap net income of $40.8M or $0.33 per diluted share, an increase of 8% year-over-year compared to Q2 of 2023 of $37.8M or $0.33 per diluted share. Coupled with our disciplined approach to cost management, this increase in net income is driven by organic growth of FERDAPs and FICOMPA and the addition of a GAMRI. Non-GAAP net income for the second quarter of 2024 was $69.6 million, or $0.56 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FICOMPA, AGAMRI, and RESURGY of $9.3 million, stock-based compensation expense of $4.4 million, the income tax provision of $15 million, and depreciation of $91,000. This compares to non-GAAP net income in the second quarter of 2023 of $60.4 million, or 53 cents per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FICOMPA and RESURGY of $8.5 million, stock-based compensation expense of $3.3 million, the income tax provision of $10.8 million, and depreciation of $82,000. Our effective tax rate through the first half of 2024 was 24.5% compared to 21.5% through the first half of 2023. The effective tax rate is affected by many factors, including the number of stock options exercised in any given period and is likely to fluctuate in future periods. Cost of sales expense was approximately $15.4 million in the second quarter of 2024. compared to $12 million in the second quarter of 2023 and consisted principally of royalties. As a reminder, royalties for FERDAPs increased by 3% when net product sales exceed $100 million in any calendar year, which was surpassed during the second quarter of 2024. As a result, we expect cost of sales to trend higher as the year progresses. Additionally, GAMRI carries the royalty in the range of low double digits to mid-20s as a percent of net revenue, depending on sales achievements within a calendar year. Further details on our royalty obligations for GAMRI are disclosed in our Q2 2024 Form 10-Q and are expanded upon within the MD&A section. Research and development expenses were $3 million in the second quarter of 2024, slightly down from $4 million in the second quarter of 2023. SG&A expenses for the second quarter of 2024 totaled $40.7 million compared to $28.4 million in Q2 2023. The overall difference in SG&A expenses in the second quarter of 2024 was principally due to incremental operating expenses in support of the launch of the GAMRI. As reported, we ended the second quarter of 2024 with cash and cash equivalents of $375.7 compared to $137.6 million at December 31st, 2023. The increase in cash of $238.1 million was driven in part by the January 9th, 2024 capital raise that resulted in $140.7 million in net cash proceeds. The remaining increase in cash is driven primarily by $96.1 million generated from operations of the business. I'd like to note that we generated approximately $53.2 million more in cash from operations for the first half of 2024 than we did for the first half of 2023. This underscores our strategic and effective capital utilization, driving incremental cash flows for the company's benefit. We believe our current funds continue to provide the financial flexibility to support our strategic initiatives including business development and portfolio expansion, meet our potential contractual obligations, and sustain our commercial and R&D programs. More detailed information analysis of our second quarter 2024 financial performance may be found in our quarterly report on Form 10-Q, which was filed with the Securities and Exchange Commission yesterday, August 7th, and can be found on the Investor Relations page on our website at www.catalystpharma.com. At this time, I will turn the call back over to Rich. Rich?
Stephen Miller
Thanks, Mike. The momentum in our portfolio is exciting. Ferdaps continues to grow as predicted due to the incredible focus of our field teams. Agamri is off to a great launch due to the strong partnership between our medical, commercial, and patient advocacy teams. And Phycompa continues to deliver in the highly competitive market because of the relentless focus of our epilepsy team. We had a robust start to this year, and we look forward to a strong second half in 2024. We are confident in our ability to capitalize on the opportunities ahead. Our unwavering commitment to advancing patient care, unlocking growth potential, and delivering value to our stakeholders remain to the forefront of our efforts. Supported by our exemplary track record and our dedicated team, we are ideally positioned to drive further growth and achieve sustained success. At Catalyst, our mission is resolute. to pioneer innovative medicines for patients with rare orphan diseases. We look forward to providing updates on our progress, and we thank our catalyst team for their commitment and all of you for your continued support. We now turn the call back over to our operator. We look forward to answering your questions. Thank you.
Operator
Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Thank you. Our first question is from Charles Duncan with Cantor Fitzgerald. Please proceed with your question.
Charles Duncan
Hey, good morning, Rich, Jeff, and team. Congratulations on a really nice 2Q. And thanks for taking our questions. I had a couple. First of all, on a gamary, do you believe that there was any bolus in the first quarter of sales because patients or caregivers were waiting for the drug to be approved and launched? And then secondarily, I know you don't have any experience with this yet in this market. but what would you anticipate for summer in terms of patient and prescriber attendance, if you will?
Stephen Miller
Charles, thanks for the question. This is something we thought a lot about, especially as we queued up the patients beginning in December of last year. I'm going to turn it to Jeff. Jeff will give you the answer. Thanks.
Jeff
Hi, Charles, and thanks for your question. There was significant pent-up demand leading up to the commercial launch that we had in March. So yes, to answer your first question, we did see significant interest prior to that, which helped the late launch, the late part of Q1, but also it helped Q2. So again, strong pent-up demand there. We are seeing, again, significant demand and interest moving forward. What we see is a lot of the sites, I mentioned it on the call, 80% of the high volume centers of excellence for DMD have enrolled at least one patient. And we've seen greater than 140 healthcare providers prescribe or submit an enrollment for a GAMRE. Now what we expect moving forward are the increase in the depth of interest from those physicians in the centers. as we move into Q3 and Q4. So, yeah, we are excited about the demand so far, and we expect that to continue.
Stephen Miller
So, Jeff, as far as Charles' question regarding the summer, do you see any sequicity so far in the summer? Any downward trend or upward?
Jeff
We see continued strong interest, Charles, so we expect the launch trajectory to stay the same.
Stephen Miller
And then, Charles, to the first part of your question, this bolus we saw, I think we referred to this in the first quarter call as a step up. So we had a very light first quarter because we only had two weeks. We expected to have this nice step up and then what we see is a continued traditional curve, and that's what I think we're experiencing. Thanks for the question.
Charles Duncan
That's helpful. A quick question on Ferdaps. Congratulations on the approval of the new higher dose. I had a question about that in terms of the future adoption and persistency, if you will, for patients. Will the new dose impact discontinuations, either fewer discontinuations due to increased efficacy or satisfaction, or will it perhaps result in more discontinuations due to less tolerability. What's your sense of how that adoption of that higher dose will go for continued use?
Jeff
Good question, Charles. And what I can tell you is, again, our annual discontinuation rate is under 20%. And within that, we see the majority of the discontinuations happen within six months of prescribing or initiating therapy on Ferdaps. So at this time, we don't expect the discontinuation to change or increase because of that more flexibility in the dose going up to 100 milligrams.
Charles Duncan
Okay. Last quick question for Rich, bigger picture strategy, thinking about some of, you know, what you have to bring to the party in terms of in licensing. Do you have a goal for yet this year? And are you focused more on neuromuscular or perhaps rare epilepsy or other areas of, you know, call it neuroinnovation? Thanks.
Stephen Miller
Great question, Charles. So our business development strategy remains the same. We're looking at orphan and differentiated orphan. We're looking at things that are accretive or nearly accretive, and we want to bring in income diversity. So we like the opportunities in neuro because we feel like we have a great footprint there, but we're not stopping. We're not just isolating ourselves to neuro because we believe that the infrastructure that we have behind the outward facing organization, the sales organization, the patient advocacy organization, really supports just about any orphan condition that we would have. So we really feel like we can bring that strength to anything. So we like the neuro space, but we really want to move within the neuro space if the opportunity presents itself, when it does present itself, or outside. So we're looking very broadly. We want to take advantage of those opportunities that come our way.
Charles Duncan
Thanks, Rich. Nice quarter.
Stephen Miller
Thank you very much, Charles. We really appreciate your support.
Operator
Thank you. Our next question is from Samantha Semienkow with Citibank. Please proceed with your question.
Samantha
Hi, good morning, and thanks for taking the question, and let me add my congratulations on a really nice and strong quarter. So while it's still really early in the launch for Gamma-8, I'm wondering how you think about the patient mix will evolve over the next several quarters. It seems the percentages that are coming from Enthalasa and prednisone thus far are really holding steady from what you shared on the first quarter. And I'm wondering how generic and SLAZA is fitting into the overall steroid landscape as well. And then I have a follow-up.
Stephen Miller
Thanks, Samantha. Those are great questions. I'll turn it right over to Jeff for that.
Jeff
Hi, Samantha. As far as the mix moving forward, we expect it to remain the same, like you said. It's pretty flat and similar to what we saw early on in the launch, and it's carried forward. We're very excited about that because it shows the strong interest in the adoption of a GAMRI across all patients that were on steroids, not just a specific segment. So excited about that. As far as the generic entrance for Inflaza coming over, and we have not seen an impact so far on adoption of a GAMRI for those patients. So no impact early on.
Samantha
Got it, great. And then just on FERDAPs, I wonder if you could share just any updates on the process or the timing of the ongoing FERDAPs Paragraph 4 litigation. And thank you.
Stephen Miller
Steve, do you want to take that?
spk04
Sure. Well, Samantha, as you know, it's generally bad practice to comment on ongoing litigation. I can tell you that we are working diligently to bring the cases to a rapid as favorable a manner as possible for Catalyst.
Samantha
Understood. Thanks so much for taking the questions.
Stephen Miller
Thank you.
Operator
Thank you. Our next question is from Jason Gerberry with Bank of America. Please proceed with your question.
Jason Gerberry
Hey, good morning. Thanks for taking my questions. Maybe just first on BizDev, are you generally inclined to do more deals funded with cash and back-end success-based milestones or talk about maybe appetite to take on some leverage to go after some larger targets that could be more transformational?
Stephen Miller
Great question, Jason. So we would be looking for opportunities to add to the income statement right now and look for that opportunity. I think we could handle a deal or two with the cash that we have, and then I think we would probably look to dip into a leverage opportunity. After that, I think we would be looking to look for more of a transformational opportunity. We like the building of the income diversity as a stepwise function for the company. We think that's the best path forward for us. We like our product mix at this point in time. And we want to build up that strength of the income statement and continue to build a balance sheet. And at that point, I think looking at more of a transformational opportunity. Mike, any comments?
Michael Kahl
I think you covered it. We have a strong balance sheet. We're ready. Yep.
Jason Gerberry
So it sounds like maybe more of a sequencing of deals where something that involved leverage would be after other deals that maybe improve your profitability. in your cash flow base than you'd consider larger transformational deals. Is that the right way to think about it?
Stephen Miller
I think so, yeah. When you think about what we're trying to do is build up the strength of the company. We feel like we're really in a great position right now. We feel like we're strong. We know we're strong. And then as we think about the long term of the company, we want to work our way back in the pipeline. So as we build that future orientation of the company, we want to have that strong cash flow strong balance sheet to be able to take on that transformational opportunity. Okay.
Jason Gerberry
And then if I can ask a question about Ferdaps, just the growth that you're seeing, it looks like maybe it's two-thirds volume, maybe a third price mix. I assume that that volume is mostly patients that don't have small cell lung as a component of their disease. So is that kind of what you're seeing in terms of the mix and what's driving this kind of 15 to 20% growth?
Jeff
It's pretty accurate there. We are seeing, you know, from the non-small cell lung cancer LEMS patients, we've seen steady about a low 20% as far as our mix goes of our total LEMS patients that have small cells. So, you know, we expect that. It's our opportunity moving forward to help increase that share. As I mentioned on the call, about 90% of those patients, small cell lung cancer lens patients, are undiagnosed there, are undiagnosed at this time. So we're applying a lot of resources towards helping those patients get diagnosed sooner. So that's where our growth will be coming from. But as far as today, you're accurate about how you described dividing up that growth. Got it. Thanks so much, guys. Thank you.
Operator
Thank you. Our next question is from June Lee with Truist Securities. Please proceed with your question.
June Lee
Good morning. This is Austin for June. Congrats on the quarter, and thanks for taking the questions. It was mentioned in the prepared remarks that refill rates were higher than historical norm for FERVACs. Can you explain what led to that and why you expect it to return back to 90% in the following quarters? Also on third apps, how soon after approval of the 100 milligram dose did you start seeing patients switch to the higher dose? And how much of an impact do you think they had in the quarter?
Stephen Miller
Thank you. Thanks, June. And thanks for your support as well. Jeff, do you want to take that?
Jeff
Sure. As I had mentioned on the Q1 earnings call, we saw some impact from the change healthcare that impacted the refill rate in February. Overall for the quarter in Q1, we were at about 86%, and so traditionally our historical norms are 90%. In April and May, we saw a recovery there, and we saw higher than the 90% historical norm refill rate, and it actually went up to 95% because of that. So patients that were impacted by that in Q1 filled their rates, filled their prescriptions more in Q2. We expect that to normalize and return to the 90% for Q3 and Q4, and still delivering the 15% or greater growth for FERDAPs. As far as the 100 milligram expansion, you know, it's a great thing for patients and healthcare providers. It really does give them the flexibility to manage and treat their LEMS symptoms. And also, just a quick step back, 40% of LEMS patients prior to the label expansion were on 80 milligrams. And those patients, the average daily dose went up by about a milligram, 1.1 milligram, since that label expansion. We did not expect or do not expect that bolus to just happen immediately. We expect that increase of the average daily dose to reach its full impact in the subsequent quarters.
June Lee
Thank you.
Stephen Miller
So I just want to clarify a statement Jeff made. Fifteen percent growth is 15 percent growth over Q2 2023, just to clarify. So we've turned to that growth as we do a comparison. We look at Q3 2024, the 15% growth we'll see is versus Q3 2023. Thanks.
Operator
Thank you. Our next question is from Leland Gershel with Oppenheimer and Company. Please proceed with your question.
Leland Gershel
Hi, good morning. My congrats on the strong quarter as well. And thanks for taking the question. Just a question again on Agamri. You know, these patients with Duchenne often are not seeing their specialists that frequently if they're medically stable, you know, maybe once every three months, sometimes once every six months. I'm just wondering if you've been seeing patients coming in to switch to Agamri because it's now available, or are they sort of waiting for their next visual deployment to change steroids? Just sort of an observational question if you have questions. Thank you.
Jeff
Hi, Leland. It's really Center of Excellence specific. Some sites had that pent-up demand, like I mentioned earlier, where they were ready to go as soon as it became commercially available. And then over time, they will wait for other patients to come in and have that discussion. And in other cases, there's outreach going on to the boys living with DMD and their caregivers about switching. So it really is specific. It's dependent on the staff and the physicians, how they want to go, the process that they put in place. Okay, thanks very much.
Operator
Thank you. Our next question is from Joe Catanzaro with Piper Sandler. Please proceed with your question.
Joe Catanzaro
Great. Hey, everybody. Thanks for taking my questions. Maybe first one, honing in on per depth a bit more. I'm curious, Jeff, what do you attribute the sort of highest level of new patient starts in the quarter to? I know you cited a couple things. Maybe you could just speak to that, which of those you expect to sort of continue and maybe which factors maybe fade, if at all. That'd be super helpful, and then I have one quick follow-up. Thanks.
Jeff
Sure. Hey, Joe. As we constantly mention, and I think it's very important in ultra-orphan disease, is to maintain that pipeline that we always do, and that's over 500 patients that are in various stages of their LEMS journey. And, you know, so we have ongoing conversations between the field and the healthcare providers with those patients. That's where we have the most success, and about 40 to 50% of our new enrollments come from those leads. So as a team, what we constantly focus on are increasing the voltage-gated antibody testing, the VGCC antibody testing, and then when those patients are tested, and if they are positive, we usually can identify where those patients are through our lead sources, and then we try to help those patients by giving those leads to our RANs. But that's how we ensure that we always have a robust pipeline for future enrollments. And we will continue to do that, and we're always on the search to find additional sources of new leads.
Joe Catanzaro
Great. That's helpful. And then my quick follow-up, I guess, on portfolio expansion. Rich, I read into maybe some of your comments as there being sort of inbound inquiries to you guys. Wondering if you could characterize the current projects that you're diligencing, you know, how many of those, what percent originated as inbound inquiries versus outbound inquiries?
Stephen Miller
Thanks. That's a great question, Joe. Really, I think what we see now is an uptick in inbound inquiries because of the performance that we see, we're seeing, I guess the best way I could characterize it is that we are, we're looking at the performance of the company and now the execution, we're getting these inquiries because we're a place that people want to place their products. So I would say we're probably at a 30, 30%, 35% of the inquiries, I'm sorry, of the products that we're talking about are inbound, where people are calling us and saying, hey, we'd like to talk to you about an opportunity. And I think that's really exciting. You can go from one product to three products in the space of about 18 months, and you're really hustling for products. And we continue to hustle for products. I want to emphasize that. We are working diligently to bring on new products that fit who we are and are differentiated, which is critical for us. to have companies approach us with products that are in our space and fit. We're excited about that. So I'd say about 30, 35%. Okay, great.
Joe Catanzaro
That's helpful and interesting. Thanks for taking my question.
Stephen Miller
Thank you. Thanks for your support as well.
Operator
Thank you. There are no further questions at this time. This does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.
Disclaimer