Q2 2022 Catalyst Pharmaceuticals Inc Earnings Call
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If anyone should require operator assistance during the conference, please press star 0 on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Ali Brandon. You may begin.
Good morning, everyone, and thank you for joining our conference call to discuss Cata's second quarter 2022 financial resource and corporate highlights.
Leading the call today is Patrick Macanani, Chairman and Chief Executive Officer.
We are also joined by Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, and Jeffrey Zell-Carmen, our Chief Commercial Officer.
Before we begin, I would like to remind you that in the following comments 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 Law.
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 prove not to be addressed, especially in light of the continued effects of COVID-19.
Actual results may vary from the expectations contained in our forward-looking statements. The forward-looking statements should be considered only in conjunction with the detailed information contained in our FCC filings, including the risk factors described in our 2021 Annual Report on Form 10-K . At this time, I'll turn the call over to Pat.
Thanks, Sally.
Good morning everyone and thank you for joining us today on our second quarter 2022 financial results and corporate update call.
We are very pleased to report that we delivered exceptional financial performance again for the second quarter of 2022, having achieved an all-time high in total FERDAPs net revenue of $53 million, representing an increase of 57.7% compared to the same period last year.
Net income before income taxes for Q2 of 2022 was $28.2 million, a 77.6% increase compared to $15.9 million for Q2 of 2021.
We reported GAAP net income of $21.6 million for Q2 of 2022, or 21 cents per basic share and 20 cents per diluted share.
We continue to bolster our cash position as we ended the second quarter of 2022 with $220.8 million in cash and investments and no funded debt.
Our second quarter results reinforced the strength of our strategy.
and we are maintaining our full year 2022 guidance of total revenues to be between $195 million to $205 million.
And as of now, we are guiding to the upper end of that total revenue range.
We continue to expect operating expenses of $65 to $70 million for the full year.
Our success is directly attributable to the continued exemplary execution by all of our employees in every functional area. Your continued dedication to ensuring the patients come first in all of our daily activities at Catalyst leads to our successful execution and progress as individuals and as a company.
Our confidence and our strong cash flow enabled us to opportunistically take advantage of the market conditions by repurchasing 600,000 shares of our common stock in the open market during the second quarter at an average price of $7.26 per share or about $4.4 million.
Since the start of our share repurchase program in March of 2021, we have repurchased approximately 3.2 million shares for an aggregate price of an average price of $5.92 per share or about $19 million in the aggregate.
We will continue to be disciplined in executing share repurchases when we feel it is prudent and beneficial to our shareholders.
Allie will provide more financial details in her presentation.
We are pleased to have resolved our issues with Jucovis Pharmaceuticals by reaching a mutually agreeable settlement to the patent litigation and the litigation challenging to reserve your approval.
As part of the settlement agreement, we have acquired certain intellectual property rights, including US and Mexico rights to resurge and its US NDAs.
We also received a license of use for their know-how related to the manufacturing of the product.
We believe the data included in the agreement may be useful, in addition to our existing data, to assist in optimizing FERDAPs' accrued labeling.
We are pleased to report that the transition of assets is underway and occurring efficiently.
As of now, we plan to use the limited supply of Resurgi that we repurchase from Jucobis to supply those patients with neuromuscular conditions other than limbs who are without access to an approved drug and who were being treated with Resurgi at the time of the settlement under investigators sponsored by NDs.
At the same time, we will continue to concentrate our focus and resources on addressing the full needs of the LMS patient community.
Having completed this transaction just several weeks ago, we are continuing to evaluate the complexities and the issues related to our path forward for a resurging in the U.S. and Mexico.
With that said, our supplemental new drug application to support the approved use of FERD-Aps for pediatric lens patients has been accepted by the FDA for review. If approved, this would likely expand the use of FERD-Aps for this age group later this year.
While the US LIMS pediatric population is a minimal number of patients, this initiative is part of our commitment to ensure that all patients have access to FERDAPs for the treatment of LIMS.
During this quarter, we also made significant progress in our efforts to identify acquisition opportunities towards building a diversified, patient-centered portfolio aligned with our overarching growth strategy.
Our key priority on this strategy and business development front continues to remain broadening and diversifying our product portfolio through collaborative partnerships, acquisition of commercial stage assets or acquisitions of companies with approved rare disease therapies.
To accomplish these objectives, our Chief Strategy Officer, Dr. Preeti Sundaram, is tasked with spearheading a stringent and disciplined approach to evaluating assets for portfolio expansion.
At this time, we're actively engaged in advanced stages of due diligence and evaluating several opportunities to acquire products and or companies with commercial stage products.
While no agreements have been entered into at this time, we believe we are on a path to accomplish this objective in the second half of this year.
We look forward to providing updates on our progress as permissible.
We've also made significant progress in building the foundation of our formal Environmental, Social and Governance, or ESG program.
We recently published our inaugural set of industry-specific disclosures recommended by the Sustainability Accounting Standards Board, or SASB, which is now available on the Catalyst website.
This initiative constitutes the first stage of our ESD journey, and we look forward to advancing our efforts on this front.
In summary, our exceptional performance was driven by the achievement of several important milestones resulting in the financial accomplishments for the quarter and increasingly strong cash possession.
We are optimistic about our future and believe we are well positioned to continue to execute our growth strategy to deliver long-term value for stakeholders.
I'll now turn the call over to Jeff Del Carmen, our Chief Commercial Officer, who will provide further highlights on our commercial performance.
Thanks Pat and good morning everyone. The commercial team delivered another strong quarter, building upon the momentum from Q1.
Q2 FERDAP's net sales were $53 million, which represents 23.3% growth quarter over quarter and 57.7% growth quarter versus the same quarter last year. I'm proud of the flawless execution demonstrated by the entire commercial organization.
We were successful in accomplishing our two main commercial objectives in Q2.
seamlessly transitioning the remaining adult Resergy Lems patients to FERDAPs without elapsin therapy and continued significant organic growth through naive new patient enrollment.
While a few more Resergy patients may transition to FERDAPs over the next few months, we feel that close to 100% of adult LEMs patients formerly on Resergy are now being treated with FERDAPs.
Payer approval rates were greater than 90% for adult LEM patients transitioning from Resergy.
the Catalyst Patient Services team did a tremendous job supporting the needs of adult LEM patients, caregivers, and healthcare professionals.
during this process to deliver uninterrupted therapy.
Our organic growth was also strong with 36 percent more naive new enrollments in Q2 than in Q1.
June naive new enrollments matched March 2022 for the highest monthly total since launch.
Additionally, operational excellence maintained favorable access of greater than 90% across all payers, government or private commercial insurers, continued high compliance of greater than 90% and contributed to an annual discontinuation rate of approximately 15%.
Patients enrolled in Catalyst Pathways, including those who are covered by Medicare and accessing Foundation assistance, have an average copay of less than $2 per month.
We expect steady organic growth in the second half of 2022, primarily driven from new patient enrollments of already diagnosed LEM's patients, not yet on FERDAS, as well as the significant number of patients that are unfortunately misdiagnosed or undiagnosed.
Leading indicators thus far in Q3 are very positive.
July net new patients were ahead of forecast due to low discontinuation rates and consistent new enrollments.
Our marketing strategies continue to deliver significant return on investment by generating robust patient leads, as well as educating healthcare providers, patients, and caregivers about LENs and FERD apps.
We currently have approximately 500 high quality patient leads stemming from our salesforce, non-personal promotion, and a non-personal promotion.
various data sources, digital marketing, inside sales and conferences.
Our focus on these leads will help accelerate the opportunity for these patients to receive treatment for this disease.
As I have mentioned in the past, another opportunity for organic growth is the approximately 50 to 60% of cases of LEMs that are associated with an underlying cancer, typically small cell lung cancer.
Recent new enrollments are approaching 25% tumor lapse.
Our focused efforts to educate small cell lung cancer treaters through multiple marketing channels continue to show strong engagement.
yielding even more patients with a proper diagnosis of lumps.
We continue to demonstrate our commitment to the LEMS community. In July , Catalyst brought together legacy LEMS patient ambassadors, new ambassadors, and the LEMS Patient Advisory Council.
for training insights and the opportunity to interact with other LEMS patients. This inaugural patient forum is believed to be the largest gathering of LEMS patients in the United States.
Furthermore, we participated at several regional and national conferences.
such as the American Academy of Neurology, ASCO, and the International Lung Cancer Conference to educate their members about limbs and foreacts.
In closing, we are pleased with our performance in Q2 and are excited about the significant opportunity ahead to help all adult LEMSS patients. We are confident that the strategies and tactics we have put in place will deliver sustained organic growth in the second half of 2022 and beyond. I want to thank the entire team at Catalyst for their unwavering commitment to the LEMSS community.
I'll now turn the call over to Dr. Steven Miller, our Chief Operating Officer and Chief Scientific Officer for an update on R&D activities.
Thanks Jeff. Our clinical and regulatory strategy for FERDAPs continues to focus on expanding access to all patients for the treatment of LEMs and enhancing the FERDAPs patent estate to maximize commercial durability.
I will begin by discussing key updates around recent events relating to our intellectual property estate for FERDAPS.
The recent favorable settlement of the patent litigation resolving certain intellectual property disputes demonstrates the robustness of our FERDAP intellectual property estate and reinforces its exclusivity which has patent expiry dates to 2034.
As part of the settlement agreement, we acquired two patents that will further bolster our intellectual property portfolio for FERDAS.
One of these two patents meets the FDA's requirements for Orange Book listability and as such it was filed for listing in the FDA's Orange Book.
This will bring the total number of Orange Book listed patents to six and should provide additional intellectual property protection to February 25, 2037.
While the other patent is not listable in the orange book, it is still a valid patent and that is applicable to products containing amifampradine and is therefore enforceable.
As part of the patent litigation settlement, we acquired the U.S. and Mexico rights to ros 71.
The acquisition of this asset aligns with our goals to serve all patients. We continue to supply Risurgi to existing IND holders for their patients that were on therapy at the time of the acquisition and will also offer assistance to transition to investigational amifabricine phosphate or commercial FERDAPs if applicable and if the patient's doctor feels the transition to these products is in the best medical interest of the patients.
This is consistent with our goal of providing a safe and effective therapy for all LENS patients.
During the first quarter of 2022, we filed a US supplemental new drug application seeking approval for FERDEP to treat pediatric LEMPS patients, and that supplement was accepted for review in the second quarter of this year.
We expect the agency to act on this supplement this year and we remain cautiously optimistic. The FDA will find it acceptable and approve it.
While this initiative was underway prior to the litigation settlement, the recently acquired Risurgi safety data for pediatric LEMs may be beneficial in providing additional support for this supplemental NDA if needed. As you may recall, the previously approved Risurgi NDA was for pediatric use in LEMs patients. For more information, visit www.risurgi.com
An approval of this supplement would expand the access to FERDEX to include children aged 6 and above as well as adults. However, as Pat mentioned, the pediatric LEMs patient population is a very small patient group with a total U.S. population estimated to be less than 30 in the United States.
We also plan to seek through a supplementary NDA to increase the maximum dose of FURDOT from 80 mg per day to 100 mg per day.
A number of FERDAS patients are already being treated at this dose after their physicians worked with the specialty pharmacy and the insurance providers to justify the higher dose.
This planned supplement will offer healthcare providers yet another tool to optimize the treatment of patients with FERDAPs along with our many other patient support programs. The previously prescribed acquisition of Rzergi rights will also give us access to safety and efficacy data that further supports catalysts seeking an increase in the FERDAPs maximum dosage to 100 milligrams daily. As a reminder, Rzergi was previously approved at a maximum dosage of 100 milligrams per day for children.
These initiatives are part of our ongoing commitment to provide an approved safe and effective treatment for all LEMs patients.
Moving on to patients with neuromuscular conditions other than LEMs, at the time of the settlement agreement some patients were receiving Rieserke treatment for these neuromuscular conditions under FDA required investigator sponsored INDs. We are presently able to continue to supply Rieserke to those patients currently receiving treatment under these INDs. In doing so, our teams are actively verifying that these IND applications are current and patient engagement with these physicians is ongoing.
This is important because the physicians treating these patients have an obligation to monitor the safe use of
Recently, our Chief Medical Officer and I participated in an in-person meeting with our sub-licensed partner, Daito Pharma, in Japan to discuss the progress related to the FURDAPs Phase III clinical trial in Japan. The trial is proceeding on the previously disclosed schedule and we anticipate the study to be completed in early 2023.
In addition, translation of catalyst MBA documents to Japanese is underway in order to assemble and file an MBA in Japan in late 2023 or early 2024.
Finally, on the long-term strategy front, we have been accelerating our efforts with our business development initiatives and we are making substantial progress in evaluating strategic opportunities. We remain confident in identifying the right opportunities to maximize our capabilities and resources.
We have uniquely strong teams that are highly aligned with these content and as we continue to execute on our initiatives across our business development and operations enterprises to achieve our goals. Our recent achievements demonstrate our ongoing ability to manage our initiative successfully and achieve important milestones that have us in an excellent position to further advance our long-term growth strategies. At this time I would like to turn the call over to Ale Grande our CFO .
Thanks, Steve. We are very pleased with our financial results for the second quarter of 2022.
Total revenue for the second quarter of 2022, principally from FERDAP's product revenue net, was $53.1 million, a 46.1% increase when compared to total revenue of $36.4 million for the second quarter of 2021.
Net income before income taxes for the second quarter of 2022 was $28.2 million, a 77.6 increase year-over-year compared to net income before income taxes for the second quarter of 2021 of $15.9 million.
We reported a gap second quarter 2022 net income of $21.6 million or $0.21 per basic and 20 cents per diluted share an increase of 77.5% year-over-year.
compares to the second quarter of 2021 gap net income of $12.2 million, or 12 cents per basic and 11 cents per diluted share.
Our effective tax rate for the first half of 2022 on an annualized basis of 23.7% compared to 23% for the first half of 2021.
For 2022, we expect that we will continue to benefit from the use of our deferred tax assets, primarily the Florida state net operating losses and the orphan drug tax credit, although those are subject to certain limitations resulting in a more normalized tax rate.
non-GAAP net income for the second quarter of 2022 was $30.3 million, or $0.29 per basic and $0.28 per diluted share, which excludes from GAAP net income of $21.6 million, stock base compensation expense of $2 million, depreciation of $37,000, and an income tax provision of $6.6 million.
This compares to non-GAAP net income for the second quarter of 2021 of $17.4 million or $0.17 for a basic and $0.16 for diluted share, which excludes from GAAP net income of $12.2 million, stock-based compensation expense of $1.5 million, depreciation of $31,000, and an income tax provision of $3.7 million.
The above represents an approximately 73.7% year-over-year increase of non-GAAP net income.
Cost of sales of $7.6 million for the second quarter of 2022 increased when compared to $4.6 million for the second quarter of 2021. This represents 31.2% of total operating costs for Q2-22 up from 22.1% of total operating costs for the second quarter of 2021.
For the second quarters of both 2022 and 2021, cost of sales was approximately 14% of product revenue net and consisted principally of royalties.
As a reminder, royalties for FERDAS net sales increases by 3% on incremental net product sales exceeding $100 million in any calendar year. We expect to exceed $100 million in net product sales during the third quarter of 2022 and consequently expect the cost of sales to turn higher for the remaining two quarters of the year. For more information, visit www.fers.com
Research and development expenses were $4 million in the second quarter of 2022 compared to $4.5 million in the second quarter of 2021. And the expenses decreased as a percentage of total operating expenses to 16.2% for the second quarter of 2022 from 21.7% for the second quarter of 2021.
SG&A expenses for the second quarter of 2022 totaled $12.9 million compared to $11.5 million for the second quarter of 2021.
GNA expenses as a percentage of total operating expenses decreased to 52.6% for Q222 compared to 56.2% for the second quarter of 2021.
As reported, we ended the quarter with cash and investments of $220.8 million and no funded debt, which we believe will enable us to advance our R&D programs and support our strategic initiative of acquiring opportunities and innovative technologies to enable growth and body creation.
As a reminder, subsequent to June 30, 2022, during mid-July, we entered into a settlement agreement with Jackals Pharmaceuticals.
Since this was a third quarter 2022 transaction, it had no impact on our 2022 second quarter resource. However, we are currently assessing the accounting and tax impacts of this transaction.
Once our analysis is complete, we will provide guidance to the market if it is determined that the impact of this transaction is material.
More detailed information and analysis of our Q22 financial performance may be found in our quarterly report on Form 10Q, which was filed with the Securities and Exchange Commission yesterday, August 9th, and can be found on the investor relations page of our website at www.catalystforma.com.
And with that, I'll turn the call over to Pat.
I'll turn the call over to Pat. Thanks, Shelley.
In closing our prepared remarks, I'd like to add that Catalyst is well positioned to deliver sustained performance with an unwavering commitment to the LENS community and execution of our strategic priorities.
We anticipate that 2022 will continue to be a transformative year for the company, with increased momentum to diversify and invest in innovative opportunities for rare diseases.
We approach these objectives from a position of strength and look forward to enhancing our growth potential and long-term value for our stakeholders.
Finally, I'd like to thank all of our valued employees for their continued dedication and commitment to positively impacting patients' lives.
Operator, we'd now like to open the call for questions.
Thank you. And at this time, we will 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 would like to remove your question from the queue. The participant is using speaker equipment and may be necessary to pick up your handset before pressing the start keys.
One moment, please, while we poll for questions.
Our first question comes from the line of Charles Duncan with Cancer Fitzgerald. Please proceed with your questioning.
Hey yeah good morning Pat and team congratulations on a really nice quarter. Thank you for taking our
Good morning, Charles. Thank you.
Morning Pat. So quickly perhaps for I had a couple of questions kind of for each of you. The first is for Jeff on the commercial front. I guess I'm wondering as you think about that guidance range for
What are you most interested in seeing happen to achieve that upper end and possibly raise anagen behaviour in order to achieve that middle set?
Would it be new patients? Would it be
Or would it be switches? It seems like the latter is already done. But what are you most keyed in on?
Sure, thanks for the question Charles. Good to hear from you. The good thing is you know all leading indicators and metrics that we've had are pointing to consistent and sustained growth.
we are looking at early in Q3 already seeing strong new patient enrollments as well as low discontinuation rates. So that's where, you know, in order to continue our growth, that's where we're going to get it from. And, you know, like I mentioned earlier,
we have significant patient leads and we know there are a lot of patients out there that we can still help and you know, we have those leads and our field force is doing a great job focusing on the treaters for those patients. So we hope to be able to help those patients and those should come in. We were hopeful here in Q3 or Q4. So to answer your question that that's where we see the the ability to hit the higher end of our of our guidance.
Okay, thank you and you provided a lot of nice detail in your prepared comments. I had fewer questions. Moving on to Steve. Steve, you mentioned pediatric limbs supplemental application realize it's not a very large market opportunity but I think from an optics standpoint it is a good one, good initiative. I guess the question that I had was are you able to provide
the FDA and secondarily use words cautiously optimistic. I'm wondering if that's just a prudent statement or is there something that you're kind of wondering about in terms of what the FDA how the FDA will review the analysis and would you bring it back soon?
Thank you for the questions, Charles. Let me answer your second question first. It's just a prudent statement. It would be very presumptuous of any of us to make a statement about what we think that the FDA is going to do. We have to respect them to do their job and review the application. So I am unaware of anything that is deficient in the...
application. We think it's acceptable, but again, that's up to the FDA to decide, not us. And can you remind me of the first question, Charles? Yeah, the information that you provided, obviously not all that granular.
Yes, obviously we had an expanded access program for years even before approval and continued it after approval for patients that wanted to continue to seek treatment. We encouraged them to switch to Resurg because that was the approved product for pediatric lens, but some patients didnít. The bottom line is that what we submitted in our application was all of the pediatric safety data that we had along with the simulation of the
how adult data translates to pediatric patients. It's exactly the same approach that Jacobus took to get Risorgi approved for pediatric patients.
Okay, makes sense. Back to you, Pat. One last question regarding business development activities. Appreciate all the color on that and the goal of completing something by the end of the year. I guess my question is, would you anticipate if something happened by the end of the year that that could be accretive to revenue opportunities next year? Would you look to leverage the established commercial infrastructure?
And finally, do you have a preference for use of cash or stock in some future transaction?
Yeah.
Great question, Charles. Obviously, we would...
Love to think we could leverage our sales force.
with the same call point. I think that's going to be difficult. We spent a lot of time.
looking at neuro and neuromuscular opportunities, and really we came up empty. So we, as you know, about a year ago, we expanded our therapeutic reach.
to look into other therapeutic categories other than oncology. But we nevertheless expect that there will be some synergy in terms of back office, market access, patient services, things like that. But not with the field force.
And we anticipate that it would be accretive to revenues next year.
We're we you know, we we
again, our focus shifted about six months ago to approved or marketed products.
So that's now where we are focused. With regard to cash or stock.
I think that.
We're in a position.
Our cash position is strong, continues to grow quarter by quarter.
We have not tapped into the debt market. We know that there's plenty of debt available if we want to take it on.
So I think the needs and the desires of a target come into play, and I think we're in equally good position to do a cash deal or a stock deal or a combination.
And our next question comes from...
I'm sorry.
Our next question is on the line over to Kanton.
Canson-Zaro with popular standard please
Hey, guys. Thanks for taking my questions, and congrats on the ninth quarter here. Maybe the first one, in terms of guidance and in light of what you saw in 2Q, where your expectations are for the pace of naïve new patient enrollments in the second half of the year relative to what you saw in the first half, it seems like you saw some good steady growth. Would you expect that to sort of continue at the same pace, accelerate, or perhaps temper in the back half of the year? Thanks, and have a follow-up or two.
Thanks, Joe, for the question. Turn that over to Jeff. Yeah, and based on the leading indicators, like I mentioned, Joe, we do expect the pace of the growth to continue. New enrollments are very strong. Discontinuation rates remain steady. So, you know, we're excited about the growth potential that's still remaining out there.
Okay, got it. And then, Jeff, go ahead, Pat. Sorry.
Yeah, no, but just to reiterate what Jeff had said earlier that
The organic growth, we still anticipate to be in the 15 to 20 percent range for the year.
And so, you know, we're confident that there are a number of naive patients out there that we can help.
Okay, I just wanted to follow up on something I think you said, Jeff, that about 25% of the naive new enrollments in the quarter were from tumor limbs. Just wondering if you have a target number there that would mean you're sort of capturing as much of that opportunity as possible.
We haven't quite established what the target number is. You know, our goal for 2022 is to really, you know, implement some educational tools out there to help physicians or small cell lung cancer treaters to learn about LEMs and then that there's a treatment out there, FERDAPs. So, you know, that was our whole goal, to learn and to implement those channels or those programs this year and then to see more of the return next year.
We're happy to see the initial return here, so the increase. I had mentioned previously that 20% of the new enrollments were about about 20% were tumor LEMs patients. Now that we're starting to see about 25%, we're hopeful that that'll accelerate next year to potentially 35-ish, but we haven't really put a final target in place to what we're hoping to see in 2023.
Okay, and last one from me, Steve, you mentioned that one patent you received from Jacobit that you intend to have listed. I'm wondering if maybe you could provide some details around explicitly what that one patent covers.
That patent contains claims for a new and novel previously unknown impurity that appears in all products that contain amefapatine.
Okay, got it. Thanks so much for taking my questions and congrats again on the quarter.
Thank you Joe.
And our next question comes from the line of June Lee with Truett Securities. Please proceed with your question.
Good morning guys, this is Les on for June and thank you for taking my questions. I just want to follow up on the patent question. So now after acquiring two additional patents from Jacobus, you now have a potential to have six in the orange book and IP protection out to 2037. My question is, are you aware of any potential ANDA filers for generic version of ME-Fantra than coming this fall?
Is there a chance there will be a filer? And essentially how strong is your IP to prevent any potential filers for a generic being approved? Thank you.
Well, let me answer your second question.
I'll take the first part of that, Les. You know, we...
We anticipate, as we've said, you know, very nice growth for the product long term.
And we would be remiss if we didn't think that generic.
competition or generic companies would not at some point.
file and or paragraph four. So we're prepared for that.
So we don't know of any yet, but.
We'll be ready. Steve, you want to talk about the strength of the IP?
Sure. There's very little that I can actually say regarding the strength of the patents on advice to counsel. It's generally a bad practice to talk about potential future litigation strategies. Basically, at a very high level, I can just tell you that we believe they're good patents and they are enforceable.
Well, thank you for that, caller. I've done one more for me on the...
IND patients that are still on re-surgery, when do you expect that to conclude and the patients to transition to fairlaps? Thank you.
Do you want me to take that or you Pat?
Yeah, go ahead Steve, please take that.
We are in the midst of transferring all the assets from...
Jacobus with regard to the purchase of the Risurgi assets. Part of those assets include existing inventory of Risurgi. We are still evaluating.
the duration to which we can continue to provide that and what the long-term plans are for the ongoing supply of Risergi to patients who are currently receiving Risergi.
And I'll add to that, Steve, that most of those patients under investigator I&Ds are not LMS patients.
Most are other neuromuscular conditions like congenital myosinic syndrome.
So, it's probably not appropriate to discuss off-label use.
of FERD apps for those patients at this point, Les.
Great. Thank you for that caller, guys. Appreciate it. Thank you.
Thank you.
And we have reached the end of the question and answer session. I'll now turn the call back over to Pat McEnany for closing remarks.
Thanks everyone for joining our call. We look forward to our next corporate update. Have a great day.
And this concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.
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