Earnings Call Transcript - CPRX Q2 2024

Operator, 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. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Michael Kalb, CFO. Thank you, Michael. You may begin.

Michael Kalb, CFO

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 Daly, President and CEO will be leading the call today, and Jeffrey Del Carmen, our Chief Commercial Officer, and I will also present. Additionally, Dr. Steven Miller, our Chief Operating Officer and 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 are not guarantees of 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 we filed yesterday, August 7, 2024 with the SEC. At this time, I'll turn the call over to Rich.

Richard Daly, President and CEO

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 2024, we achieved outstanding results across our commercial portfolio with total revenues of $122.7 million, a 23.2% increase over Q2 2023, underscored by record organic revenue growth from FIRDAPSEE. The successful ongoing commercialization of AGAMREE for Duchenne’s Muscular Dystrophy, and the continued solid performance of FYCOMPA. We are reiterating our full year 2024 net product guidance for both FIRDAPSEE and FYCOMPA. AGAMREE continues to deliver strong performance and we are updating our AGAMREE full year 2024 net product revenue guidance from the $25 million to $30 million range we provided earlier this year to the $35 million to $40 million. As a result of our strong performance, we are also updating our full year 2024 total revenue financial guidance. Prior to this, we guided to a full year total revenue range of $455 million to $475 million. Due to the solid performance of both FIRDAPSEE and FYCOMPA and the outstanding uptake of AGAMREE, 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 US approval for FIRDAPSEE's 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 LEM patient community. As awareness of this new dosing option grows among patients and physicians, we anticipate a gradual increase in FIRDAPSEE daily dosing over the coming quarters. In parallel, we continue to actively collaborate with our partner in Japan, DyDo Pharma, as we await the next regulatory milestones for FIRDAPSEE, 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 AGAMREE, 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 analysis 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 Kye Pharma for them to commercialize AGAMREE in Canada. As Kye already holds commercial rights for FIRDAPSEE in Canada, they expect to submit an application to Health Canada for regulatory approval of AGAMREE in early 2025. Our growing partnership with Kye 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 collaboration. 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 AGAMREE, 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 our 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 AGAMREE, 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.

Jeffrey Del Carmen, Chief Commercial Officer

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 FIRDAPSEE, stable revenues from FYCOMPA, and the strong commercial launch of AGAMREE. 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. First, let me start with FIRDAPSEE 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 and the highest quarterly total since Q1 2022. Prescription approval rates were greater than 90% across all payers, whether 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, resulting in a 15% or greater growth quarter versus the same quarter in 2023. We remain confident in achieving FIRDAPSEE 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 who are not yet on FIRDAPSEE. Half of our new patient enrollments typically come from this group, a prime reason for our ability to consistently deliver a 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 FIRDAPSEE. Lastly, as we have mentioned before, more than 90% of small cell lung cancer LEMS patients remain 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 LEMS patients. Now let me provide an update on FYCOMPA. Q2 net revenues of $36.5 million further fortify 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 FIRDAPSEE's share of voice by conducting secondary FIRDAPSEE calls with healthcare providers. This strategy leverages the 45% overlap in physician call points between FYCOMPA and FIRDAPSEE, boosting FIRDAPSEE's 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 AGAMREE. Q2 product net revenues were $8.7 million. Thanks to our dedicated efforts leading up to the March 13, 2024 product launch, we successfully exceeded our initial launch expectations. Thus far, 46% of new enrollments are transitions from EMFLAZA, while 42% are switches from prednisone, which we believe is a positive sign for the acceptance of AGAMREE. In addition, approximately 80% of the top DMD centers of excellence and greater than 140 healthcare providers have submitted at least one AGAMREE enrollment form, and around 89% of our current patients are reimbursed, averaging less than 30 days to approval. We expect the time to approval to decrease as payers finalize their policies over the next couple of months. Based on the promising demand trend and encouraging payer landscape, we are revising our AGAMREE 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 FIRDAPSEE reflecting our commitment to sustained organic growth. We continue to achieve stable net revenues with FYCOMPA and are surpassing our revenue projections for AGAMREE. 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 2024. I will now turn the call back over to Michael.

Michael Kalb, CFO

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 AGAMREE in mid-March, along with the continued performance of FIRDAPSEE and FYCOMPA, 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 GAAP net income of $40.8 million or $0.33 per diluted share, an increase of 8% year-over-year compared to Q2 of 2023 of $37.8 million 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 FIRDAPSEE and FYCOMPA and the addition of AGAMREE. 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 FYCOMPA, AGAMREE and RUZURGI 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 $0.53 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FYCOMPA and RUZURGI 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 FIRDAPSEE 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, AGAMREE carries royalties in the range of low double digits to mid-twenties as a percent of net revenue, depending on sales achievements within a calendar year. Further details on our royalty obligations for AGAMREE 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 AGAMREE. As reported, we ended the second quarter of 2024 with cash and cash equivalents of $375.7 million compared to $137.6 million at December 31, 2023. The increase in cash of $238.1 million was driven in part by the January 9, 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 would 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 and 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 7, and can be found on the Investor relations page on our website. At this time, I will turn the call back over to Rich. Rich?

Richard Daly, President and CEO

Thanks, Mike. The momentum in our portfolio is exciting. FIRDAPSEE continues to grow as predicted due to the incredible focus of our field teams. AGAMREE is off to a great launch due to the strong partnership between our medical, commercial, and patient advocacy teams, and FYCOMPA continues to deliver in the highly competitive market. Because of the relentless focus of our epilepsy team, we had a robust start 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 remains at 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, Operator

Thank you. We will now be conducting a question-and-answer session. Our first question is from Charles Duncan with Cantor Fitzgerald. Please proceed with your question.

Charles Duncan, Analyst

Hey, good morning, Rich, Jeff, and team. Congratulations on a really nice Q2 and thanks for taking our questions. I had a couple, first of all, on AGAMREE. 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?

Richard Daly, President and CEO

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.

Jeffrey Del Carmen, Chief Commercial Officer

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 part of Q1, but also it helped Q2. So again, strong pent-up demand there. We are seeing 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 AGAMREE. Now, what we expect moving forward are the increases in the depth of interest from those physicians in the centers as we move into Q3 and Q4. So we are excited about the demand so far, and we expect that to continue.

Richard Daly, President and CEO

So, Jeff, as far as Charles' question regarding the summer, do you see any cyclicity so far in the summer, any downward trend or upward?

Jeffrey Del Carmen, Chief Commercial Officer

We see continued strong interest, Charles. So we expect the launch trajectory to stay the same.

Richard Daly, President and CEO

And then, Charles, to the first part of your question, this bolus we saw, we had a very light first quarter because we only had two weeks. We expected to have this nice step-up, and what we are experiencing is a continued traditional curve. That's what I think we're experiencing. Thanks for the question.

Charles Duncan, Analyst

That's helpful. Quick question on FIRDAPSEE. Congratulations on the approval of the new higher dose. I had a question about that in terms of future adoption and persistency 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?

Jeffrey Del Carmen, Chief Commercial Officer

Good question, Charles. Our annual discontinuation rate is under 20%. Within that, we see the majority of the discontinuations happen within six months of prescribing or initiating therapy on FIRDAPSEE. So at this time, we don't expect the discontinuation to change or increase because of the more flexibility in the dose going up to 100 milligrams.

Charles Duncan, Analyst

Okay, last quick question for Rich. Bigger picture strategy. Thinking about some of what you have to bring to the party in terms of licensing, do you have a goal for this year? And are you focused more on neuromuscular or perhaps rare epilepsy or other areas of neuro innovation?

Richard Daly, President and CEO

Great question, Charles. Our business development strategy remains the same. We're looking at orphan and differentiated orphan therapies. We're focusing on things that are accretive or nearly accretive and we want to bring in income diversity. We like the opportunities in neuro because we feel like we have a strong footprint there. But we're not just isolating ourselves to neuro, because we believe that the infrastructure that we have behind our outward-facing organization, sales organization, and patient advocacy 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, or outside. So we're looking very broadly and want to take advantage of those opportunities that come our way.

Operator, Operator

Thank you. Our next question is from Samantha Semenkow with Citibank. Please proceed with your question.

Samantha Semenkow, Analyst

Hi, good morning, and thanks for taking the question. And let me add my congratulations on a really nice and strong quarter. So while still really early in the launch for AGAMREE, 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 EMFLAZA and prednisone thus far really holding steady from what you shared on the first quarter. I'm wondering how generic EMFLAZA fits into the overall steroid landscape as well? And then I have a follow-up.

Richard Daly, President and CEO

Thanks, Samantha. Those are great questions. I'll turn it right over to Jeff for that.

Jeffrey Del Carmen, Chief Commercial Officer

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 AGAMREE across all patients that were on steroids, not just a specific segment. So we're excited about that. As far as the generic entrance for EMFLAZA coming in, we have not seen an impact so far on adoption of AGAMREE for those patients. So no impact early on.

Samantha Semenkow, Analyst

Got it. Great. And then just on FIRDAPSEE, I wonder if you could share any updates on the process or timing of the ongoing FIRDAPSEE paragraph four litigation, and thank you.

Steven Miller, Chief Operating Officer and Scientific Officer

Sure. Well, Samantha, as 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 favorable conclusion for Catalyst.

Operator, Operator

Thank you. Our next question is from Jason Gerberry with Bank of America. Please proceed with your questions.

Jason Gerberry, Analyst

Hey, good morning. Thanks for taking my questions. Maybe just first on business development, are you generally inclined to do more deals funded with cash and backend success-based milestones, or can you talk about your appetite to take on some leverage to go after some larger targets that could be more transformational?

Steven Miller, Chief Operating Officer and Scientific Officer

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 leveraging opportunities after that. We think a transformational opportunity is what we're looking for. We like the building of 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 the balance sheet. At that point, I think looking at a transformational opportunity makes sense.

Michael Kalb, CFO

I think you covered it. We have a strong balance sheet. We're ready. So it sounds like maybe more of a sequencing of deals or something that involves leverage would be after other deals that improve your profitability in your cash flow base, then you'd consider larger transformational deals. Is that the right way to think about it?

Jason Gerberry, Analyst

Okay. And then if I can ask a question about FIRDAPSEE, just the growth that you're seeing. It looks like maybe two-thirds volume, maybe a third price mix. I assume that that volume is mostly patients who 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?

Michael Kalb, CFO

It's pretty accurate. We are seeing from the non-small cell lung cancer LEMS patients steady low 20% as far as our mix goes, of our total LEMS patients that have small cell. We expect our opportunity moving forward to help that share. As we mentioned on the call, about 90% of those patients, small cell lung cancer LEMS patients are currently undiagnosed. We are applying a lot of resources toward helping those patients get diagnosed sooner. 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.

Operator, Operator

Our next question is from Joon Lee with Truist Securities. Please proceed with your question.

Unidentified Analyst, Analyst

Good morning. This is Osma on for Joon. Congrats on the quarter, and thanks for taking the questions. It was mentioned in the prepared remarks that refill rates were higher than historical norms reported. Can you explain what led to that and why you expect to return back from 90% in the following quarters? And then also on FIRDAPSEE, how soon after the approval of the 100 milligram dose did you start seeing patients switch to a higher dose, and how much of an impact do you think they had in the quarter? Thank you.

Richard Daly, President and CEO

Thanks, Osma, and thanks for your support as well. Jeff, you want to take that?

Jeffrey Del Carmen, Chief Commercial Officer

Sure. As I mentioned on the Q1 earnings call, we saw some impact from the change in healthcare that impacted the refill rate in February. Overall for the quarter in Q1, we were at about 86%. Traditionally, our historical norms are 90%. In April and May, we saw a recovery there, and we saw a refill rate of 95%. Patients that were impacted by that in Q1 filled their prescriptions more in Q2. We expect that to normalize and return to the 90% for Q3 and Q4 while still delivering 15% or greater growth for FIRDAPSEE. As far as the 100 milligram expansion, it's a great thing for patients and healthcare providers. It really does give them the flexibility to manage and treat their LEMS symptoms. Just a quick step back: 40% of LEMS patients prior to the label expansion were on 80 milligrams. Those patients' average daily doses went up by about 1.1 milligrams. Since that label expansion, we do not expect that bolus to just happen immediately. We expect that increase in the average daily dose to reach its full impact in subsequent quarters. Thank you.

Richard Daly, President and CEO

I just want to clarify a statement Jeff made. A 15% growth is 15% growth over Q2 2020, just to clarify.

Operator, Operator

Thank you. Our next question is from Leland Gershall with Oppenheimer and Company. Please proceed with your question.

Leland Gershall, Analyst

Hi. Good morning, Mike. Congrats on the strong quarter as well. Thanks for taking the question. Just a question again on AGAMREE: these patients with Duchenne often are not seeing their specialists that frequently. If they're medically stable, maybe once every three months or sometimes once every six months. I'm just wondering if you've been seeing patients coming in to switch to AGAMREE because it's now available, or are they waiting for their next scheduled appointment to change steroids? Just sort of an observational question, if you have any perspective there. Thank you.

Michael Kalb, CFO

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. In other cases, there's outreach going on to the boys living with DMD and their caregivers about switching. It really is specific. It's dependent on the staff and the physicians and the processes they put in place.

Operator, Operator

Our next question is from Joe Catanzaro with Piper Sandler. Please proceed with your question.

Joe Catanzaro, Analyst

Great. Hey, everybody, thanks for taking my questions. Maybe first one, honing in on FIRDAPSEE a bit more 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 of things. Maybe you could just speak to that, which of those you expect to continue, and maybe which factors might fade, if at all? That'd be super helpful. And then I have one quick follow-up. Thanks.

Michael Kalb, CFO

Sure. Hey, Joe, as we consistently mention, and I think it's very important in ultra orphan disease, is to maintain that pipeline that we always do. That's over 500 patients in various stages of their LEMS journey. We have ongoing conversations with healthcare providers about those patients. That's where we have the most success. About 40% to 50% of our new enrollments come from those leads. So as a team, what we focus on continuously are increasing the voltage-gated calcium channel antibody testing, the VGCC antibody testing, and when those patients are tested and if they are positive, we can usually identify those patients through our lead sources. We try to help those patients by giving those leads to our reps. That's how we ensure that we always have a robust pipeline for future enrollments, and we will continue to do that. We're always on the search to find additional sources of new leads.

Joe Catanzaro, Analyst

Great. That's helpful. And then my quick follow-up, I guess, on portfolio expansion. Rich, I read into some of your comments as there being some inbound inquiries to you guys. Wondering if you could characterize the current projects that you're diligent in. How many of those, what percent originated as inbound inquiries versus outbound inquiries?

Michael Kalb, CFO

That's a great question, Joe. What we've seen 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 looking at the performance of the company and execution. We're getting these inquiries because we're a place that people want to place their products. I would say we're probably at about 30% to 35% of the products that we're talking about that 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. 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% to 35%.

Operator, 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.