Catalyst Pharmaceuticals Inc. Q1 2023 Earnings Call
Thank you for standing by the presentation will begin momentarily. Please remain on the wall.
[music].
Greetings and welcome to the catalyst Pharmaceuticals first quarter 2023 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.
Under this conference is being recorded.
Now my pleasure to introduce your host Ali Grande Chief Financial Officer. Thank you Allen you may begin.
Good morning, everyone and thank you for joining our conference call to discuss first quarter 2023.
Hi.
The country is Patrick Mcenany, Chairman and Chief Executive.
Uh huh.
We're also joined by Doug.
Chief operating officer, and Chief Scientific Officer and.
Yes, It was El Carmen Chief commercial officer.
And for the Q&A session.
Gary.
Medical and regulatory.
Before we begin I would like to remind you.
That in our remarks, this morning and in the Q&A.
We will make statements I would expect this is Jerry.
You may be forward looking statements for purposes.
Purposes of ferrous.
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 accurate.
Actual results may vary from the expectations contained and that's the way it is.
These forward looking statements should be considered in conjunction with the detailed information contained.
Our SEC filings, including the risk factors described in <unk> 2022.
<unk> reports on Form 10-K at this time I'll turn the call over to Pat.
Thanks Shelly.
Welcome everyone for our first quarter 2023 results conference call.
We started 2023 strong as we made meaningful progress across all of our functional areas.
I'm very pleased to report on our record breaking first quarter 2023 financial performance as shared in yesterday's press release and I will now highlight several key points.
We achieved total revenues of $85 $4 million during the quarter, representing 98% growth year over year.
The exceptional performance reflects third apps product net revenues of $57 5 million, achieving a net revenue increase of 34% year over year.
Total revenues were bolstered by five copper in net product revenues of $27 $8 million for the approximately two months.
On the U S rights to the product.
The 2023 first quarter.
non-GAAP income for the first quarter was 46 8 million or <unk> 44 cents per basic share and 41 cents per diluted share yes.
Yes, it excludes from GAAP net income noncash stock based compensation depreciation amortization of intangible assets and our income tax provision.
GAAP net income for the first quarter was $29 $6 million or 28 cents per basic share and 26 cents per diluted share.
This reflects among other expenses.
The expenses related to the amortization of the intangible assets associated with the acquisitions by copper and reserves.
Which were approximately $6 5 million expenses related to the transition services agreement with.
With Bayside third party copper where.
Approximately $7 million.
For the two months period.
And $2 $9 million in noncash stock based compensation.
We ended the quarter with a cash position of about $148 million.
The outstanding first quarter performance reinforces the belief in our strategy and we reaffirm 2023 total revenue guidance of between 375 million to $385 million, representing a 75% to 80% increase in total revenue compared.
For 2022.
We expect operating expenses of 106 hundred $70 million for the full year 2023.
Which includes amortization expenses of about $32 million for this year.
This also includes the operating expenses directly related to pipe copper, which at this time, we estimate to be $40 million to $45 million per year.
Keep in mind that we are still fine tuning our pro forma expenses to account for the <unk> acquisition.
We are also forecasting the noncash non-GAAP net income for 2023 will be between $195 million to $205 million.
During the first quarter, we announced that we successfully completed the purchase of U S rights to <unk> copper by January 24 2023.
This marks an important milestone for catalyst as we broadened our commercial product portfolio with the first and none of my noncompetitive Alpha receptor antagonists for epilepsy further augmenting the already strong revenue growth of <unk>.
Effective may one we.
We on boarded the full U S commercial team for the five capital brand, including marketing promotion and medical support activities.
I am pleased to report that.
Copper commercial medical affairs integration is for the most part completed and our newly established franchise teams are actively field engaged as of this week.
We're excited to welcome our new FA comp of team members, who bring a wealth of passion experience and expertise in the epilepsy field to the catalyst family.
Building upon our exceptional commercial capabilities, we are poised to fully benefit from our diversified portfolio to achieve targeted run rate synergies they positioned catalysts to benefit from this long term revenue and income opportunity.
Moving onto our critical business, we are making meaningful progress focused on expanding the use of <unk>.
The phase III Registrational study in Japan is progressing on plan.
We anticipate study completion by the end of 2023 and assuming success in that study, we anticipate an NDA submission to the Japanese regulatory agency.
Our partner <unk> pharma in the second quarter of 2024.
Based upon an acceptance of the NDA to market the product in Japan. We also plan to accelerate our global growth expansion strategy preferred apps into other countries in Asia, and South and Central America.
Initiatives are already underway to identify potential partnership opportunities in these territories as part of our longer term strategic growth plans.
Along with our global expansion plans. We are also planning to seek an increase from the FDA and the maximum daily dose differed apps from 80 milligrams per day to 100 milligrams per day as we know there are quite a number of <unk> patients that could benefit from being treated with 100 milligrams per day.
Just last week, we received the minutes from our type C meeting with the FDA regarding the supplemental NDA submission requirements for the application seeking to expand the maximum daily dosage preferred apps from 80 to 100 milligram.
Based on the positive response from the meeting we anticipate filing the NDA seeking approval of the change early in the third quarter of this year.
During this quarter, we gained significant ground in identifying acquisition opportunities towards building a diversified rare disease portfolio.
Our key priority on the strategy front, we made two smartly continue to broaden and diversify our product portfolio through collaborative global partnerships acquisition of commercial stage assets and or acquisitions of companies that own those type of assets are.
Company is fully resource and there is capacity from multiple perspectives to add in tuck in rare disease programs with a preference towards neurology commercial or late stage assets.
Our mission, which has been driven our strategy since inception is to improve the lives of those who suffer from rare and difficult to treat diseases.
This commitment to providing these patients who are safe and effective medicine, while enabling affordability and accessibility.
Remains core to our values.
With that in mind, we are proud to share that earlier. This month, we released our inaugural ESG report, highlighting our commitment and progress on environmental social and governance initiatives that benefit our patients people and communities.
We look forward to advancing our ESG journey as we continue building, our strong and sustainable Foundation.
Without question, we achieved meaningful results as we successfully executed across multiple initiatives, while delivering an exceptional financial performance that exceeded expectations.
Looking ahead, we are well positioned for sustained growth with our two branded products and a sound strategy for our company's future supported by our recent achievements.
Coupled with our expanding capabilities and prudent approach to capital allocation. We will continue executing our long term vision to drive sustainable growth and deliver value for all our various stakeholders.
I'll now turn the call over to Jeff Deuel, Carman, our Chief commercial officer, who will provide an update on our commercial activities.
Yeah.
Thanks, Pat and good morning, everyone as Pat mentioned catalysts had an excellent start to 2023.
And by the combination of strong start ups net revenues and compelling revenues from five copper are.
The record Q1 total net revenues of $85 4 million physicians catalyst well to achieve our combined 2023 revenue guidance of 375 million to 385 million.
First let me start with <unk> performance Q1, net sales of $57 5 million.
Representing a 34% increase quarter over the same quarter last year, a direct result of our sustained cadence of new patient starts I compliance and consistent low discontinuation rate.
Scratch and approval rates were greater than 90% across all payers government or private commercial insurers.
Patient all analysts pathways, including those who are covered by Medicare and accessing foundation assistance.
And average co pay of less than $2 per month.
Our strategic growth initiatives will continue to drive organic growth moving forward.
<unk> education programs targeting healthcare providers have already resulted in a significant increase in voltage gated calcium channel antibody tests, which will shorten the diagnostic journey for Lam stations and lead to more patients being eligible for treatment with perhaps.
Additionally, the recently hired oncology thought leader liaisons will focus on the top 30 thoracic oncology centers to accelerate diagnosis of small cell lung cancer Lemon station.
Currently greater than 80% of small cell lung cancer advanced patients are undiagnosed.
We continue to maintain a pipeline of approximately 450 diagnose lung patients that are not yet on furnaces, which contribute around 50% of new patient enrollments each quarter.
Now, let me provide an update on <unk> com.
We have established a new commercial fight comp a franchise that.
That is highly synergistic with our <unk> business.
Integration has gone exceptionally well.
Credit to the entire organization and our commercial capability to execute flawlessly without interruption to the Fedex business.
Ah by capital sales force and marketing teams are fully staffed with 34 highly experienced personnel with a deep understanding by Tampa and passion to help patients living with epilepsy.
During the first week of May we successfully held our flight Tampa launch meeting in which our <unk> commercial team was trained and certified.
On conclusion of our fine chemical franchise launch meeting.
Tire fight catheter team and our corporate leadership, we're all energized.
Future growth opportunities.
At Phi capital sales team of 27 regional account managers and three area business directors were deployed into the field effective may fit.
Q1, net revenues for <unk> were $27 8 million for the approximately two months that we own the U S rights to the product.
Which adds further confidence towards achieving our <unk> full year 2023, net product revenue forecast of $130 million.
Adding <unk> to our portfolio is an ideal strategic fit for our existing commercial infrastructure with a 45% overlap in Pi Kappa and Fedex physician call points.
And an increased share of voice that will benefit both franchises in driving growth.
In summary, we are making meaningful progress on sustained organic growth for <unk> as.
As well as the successful execution of our launch of buy copper commercial business we.
We are highly focused on continued commercial execution.
So, let's and remain confident in our 2023 total revenue guidance of 375 million to 385 million.
I want to thank the entire team are catalysts for their unwavering commitment to patients and look forward with successful 2023.
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.
Thanks, Jeff.
Clinical development and regulatory strategy for <unk> continues to focus on expanding access to <unk> patients enhancing the <unk> patent of state to maximize its commercial potential and integrating the newly acquired for copper product into catalyst organisation.
First I would like to discuss our development efforts to increase the indicated maximum dose referred us from 80 milligrams per day to 100 milligrams.
As announced earlier this week. The agency has responded that they accept our approach for the filing of a supplemental NDA, we expect U S. NDA submission to be submitted early in the third quarter of this year.
Currently there are a number of <unk> patients who are already being treated at a 100 milligram daily doses referred ups. After their physician works with the pharmacy and insurance providers to justify the higher dose.
Other patients on the current indicated maximum dose of 80 milligrams per day and their physicians have expressed the need to increase the patient's daily dosage.
The 100 milligrams to optimize therapy and this plant supplement if approved will help those patients.
We believe that our dataset constitutes an acceptable basis for seeking a 100 milligram maximum indicated daily dosage products regarding our.
Our global expansion, our sub licensee partner direct in Japan has completed enrollment and their <unk> phase III clinical trial, which is required to seek approval for the Japanese market and the safety follow up phase of that study is ongoing we continue to anticipate completion of that trial by the end of the year and far.
If a Japanese NDA submission in the second quarter of 2024.
It is estimated that there are about 200 to 1300 lamps patients in Japan.
Under our license agreement for filing of the NDA in Japan is an important milestone for <unk> and catalyst because it expands our territory further advance our efforts to expand our global footprint of <unk> into other markets in Asia.
And in Central and South America.
As previously reported.
We recently completed the acquisition of the U S rights to fight copper or for ethanol, which is the first and only approved Apple receptor antagonist for inhibitor <unk>.
Catalyst five top of integration efforts are progressing well as Jeff reported.
And we have completed the successful integration of the commercial team.
We are also well along with the process of integrating psychotics manufacturing quality and pharmacovigilance functions into our organization and anticipate beginning to distribute fly cockpit and catalyst trade dress by the fourth quarter of this year.
Emperor receptors enable fast excitatory synaptic transmission throughout the central nervous system couple of Prologis believed that seizure generation and spreading can be dependent on over activation of Apple receptors hyperactivity induced by seizures might also alter app a receptor function and duration of excitation hi, Brad.
Provision of apparatus sectors is highly toxic in a couple of apologists believes it adds to secondary.
Sure.
For example, as an Apple receptor antagonist can act to reverse these effects and improved seizure control.
Like copper is approved as an anti seizure medication to treat partial onset seizures with or without secondary generalized seizures in people with epilepsy, who we're four years of age and older and with other medications to treat primary generalized tonic clonic seizures and people with epilepsy, who are 12 years of age and older.
Moving onto our medical information function Atlas neuromuscular medical science liaison surround myself are actively reaching out to oncology health care providers to build relationships and provide education about the importance of testing their patients for labs in order to expand the use of <unk> by those patients.
Colleges that already treat language in their practice, which were found that patients referred us maintained muscle strength, improving the patients and physicians perception of wellbeing and the patient's ability to maintain functional mobility. All of these domains are critical for the patients quality of life.
Atlas has also onboard at the new Flex Hopper MSL team and their new director all with prior epilepsy experience to support for example.
By Capa is a mature product for which extensive published information in real world data is available.
<unk> team will bring this information to healthcare providers to treat epilepsy and also to address any questions that these physicians that have about using for copper at <unk>.
Previously reported a recent publication identified a number of rare epilepsy, where shrunk to responsive for carpet treatment.
As a service to the physician community Atlas provides support for the development of continuing medical education or CME programs that are part of a form of ongoing education of healthcare providers.
Atlas has over the past three years provided support for three CME programs for various aspects of the diagnosis treatment and management of lunch over this period of time over 8000 health care providers have utilized to CME programs learning modules and about 2500 have taken the CMA test in order to be granted CME credit.
With the maintenance of their medical licenses last quarter, we responded.
We sponsored a new lamp CME program targeted oncologist to treat small cell lung cancer due to the correlation between Ms cancer and associated labs in just a few months. This recent program has already had 200 learners and 280 CME testing in.
In short these programs we're now.
Through these programs we have now reached far more health care providers don't there are lumps patients.
These programs successes, maybe one of the many contributing factors to the overall commercial success of <unk> for the treatment of.
Tablets will continue to support the creation of new CME programs for both <unk> and now for for copper in the future.
Moving onto business development, Pat described our significant portfolio expansion with the acquisition of copper in the first quarter and we are continuing to identify additional assets for potential acquisition. It is also important to point out how far the capa acquisition fits into our broader business development strategy.
The specific biochemical origins epilepsy are increasingly being elucidated the field of epilepsy treatment is evolving into a precision medicine approach with increasing numbers of rare epilepsy is being identified and targeted therapies being developed for each as a rare disease company catalysts acquisition of Phytophthora is our entree into this expand.
<unk> therapeutic area.
<unk> is actively pursuing additional therapies that are commercial stage or very late stage products in development, including those could extend beyond epilepsy and neuromuscular rare disease.
At this time I would like to turn the call over to Ali Grande our CFO .
Thanks, Steve.
We saw some catalysts first quarter 2020, how citizens.
A year of exceptional financial performance and strong execution.
And the business development front, we were very close.
Closer P is the appreciation of the U S right.
$160 million in cash and integration efforts underway.
I remind you that my company operation.
Operation.
So that's where the first quarter of 2023, okay, only a little over two months of activity, yes, why their product in late January .
Revenues for the first quarter 'twenty to 'twenty, three or $85 4 million and 98% increase when compared to total revenues of $43 1 million for the first quarter 2022.
But rather than your net first of all I guess 2023.
Acquiring in late January 2021.
With $27 8 million.
Revenue for the first quarter 2023 lead product fair enough, but $67 5 million for increased year over year compared to 43 million for the first quarter 2022.
Net income before income taxes for the first quarter of 2023 87.
Seven.
In a 114% increase year over year.
$17 5 million for the first full year 2022.
We reported GAAP net income for the first quarter of 2023, $29 6 million 28 cents per basic and <unk> 26 cents per diluted share an increase of 123% year over year compared to GAAP net income for the first quarter 'twenty to 'twenty two.
Pinpoint to Marion.
Let's take two cents per basic and diluted share.
Reminder, in the first quarter of the time, they like many companies in our industry.
Are impacted by the reset of the patient deductibles.
In the first quarter, we recorded expenses related to our annual commitment to make sure I have worked on Asia about once you say your foundation.
That fund named patient programs.
Yes.
non-GAAP net income for the first quarter 2023.
$26 8 million or 44 cents per basic what he wants.
Sure.
Excluded from GAAP net income stock based compensation expense of $2 9 million.
Appreciate you know 69000.
Amortization of intangible assets related to our acquisitions, let me say.
We explained 5 million and an income tax variation of $7 7 million.
This compares to non-GAAP net income in the first quarter of 2022 of $19 4 million 13 cents per basic and 12 cents per diluted share.
Clearly from GAAP net income.
The base compensation of $1 9 million depreciation on.
And an income tax variation a footprint in the area.
Yeah, but also represents an approximately 141% increase of non-GAAP net income year over year.
As I mentioned with if I come back recession, what do you think that approximately 158 million in licensing any tangible.
We expect to amortize on a straight line basis.
Next approximately five years amortization for intangibles in connection with both.
The first concept.
In late January 2023, and there is at least <unk>.
<unk> product.
Playa during July 2022, with approximately $6 5 million for the first quarter of 2023.
Did not have any amortization in the comparable 2020 to Florida.
Not acquire either product.
In the first quarter of 2020.
We expect intangible related amortization for acquired products to be approximately $8 5 million per quarter for the rest.
23.
Our effective tax rate for the first quarter of 2023 on an annualized basis.
Eight 8%.
Page 24, 2% for the first quarter of 2022.
For 2023.
Statutory federal income tax rate of 21%, what's been really driven by state income taxes anticipated permanent differences.
But very often they are credit.
But the orphan drug tax credit claims.
Yes, it does.
Fate is affected by many factors, including the number of stock options exercise and then we give them.
Very good and it's likely to fluctuate in future periods.
Selling expenses were approximately $9 9 million in the first quarter of 2023.
Slide $49 million in the first quarter 2020.
Thanks, everybody.
So a reminder, royalties increased.
Increased by 3% when net products sales exceed 100 million in any calendar year. So we expect cost of sales to trend higher as the year progresses.
Cost of sales so if I come back in 2023.
Of amortization of intangible.
Patrick.
Research and development expenses were $3 6 million in the first quarter of 2023.
90000 people employed in the slightly up from 5 million in the first quarter of 2022.
<unk> expenses for the first quarter of 'twenty to 'twenty three 'twenty.
$29 7 million.
<unk> 16 point Boy Maryanne and Q1 2022.
SG&A expenses decreased slightly as a percentage of total operating expense at 60%, but you went to nine three compared to 64% for Q1 'twenty.
Yes.
Our defense and SG&A expenses in the fiscal year 'twenty three.
A huge commercial expenses.
Transition services agreement related to fight sometime during January 2023.
Contribution.
First of all it is 23.
Five or six of your organization.
The consideration will be used over the full year.
23.
You know it.
As reported we ended the quarter with cash and cash equivalents of $148 million.
During January 2023, we used approximately 163.
Of our available cash for the acquisition of the U S rights for quite sometime we believe our remaining funds.
While our financial flexibility.
That's all.
That's the border specific initiatives play opportunity, leading to future growth and value creation.
More detailed information on it.
First quarter 2023 financial for appointment maybe filed quarterly report.
On Form 10-Q, which was filed with the Securities and Exchange Commission yesterday May 10, and can be found on the Investor Relations page on our website.
Ww that catalyst climate dot com with that I'll turn the call over to Pat.
Thanks Sally.
In closing our prepared remarks, we are very optimistic about our path forward as we continue to strengthen our position as a leader within the neuroscience space.
We are well positioned to drive sustainable growth with our sights set on further expansion that aligns with our core mission to deliver value to patients healthcare providers and shareholders.
I am proud of our team's accomplishments let me. Thank all of our employees for their dedication and ongoing commitment to the patient communities we serve.
At this time I'd like to turn the call over to the operator to open the line for questions.
Thank you we will now be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue you May press.
Start to if you'd like to remove your question from the queue for participants using speaker equipment may be necessary to pick up your handset before pressing the star.
One moment, while we poll for questions.
Thank you. Our first question is from Joon Lee with <unk> Securities. Please proceed with your question.
Hi, Good morning. This is less on for Julien. Thank you for taking my questions first I'll start out and start ups can you talk about any seasonal trends that you might have seen in <unk>.
Other impacts that drove the quarter over quarter slide India for that sales.
Did you say slide from the product sales.
Quarter over quarter sequentially, yes.
Yeah, So Jeff do you want to take that question.
Sure.
What we saw in Q1 were very pleased with the net revenue results in Q1.
The typical seasonal factors impacted the quarter.
Such as what patients tried to do in December to ensure that they have medication over the holidays. They try to pull forward their prescriptions or the shipment into December so that impacts January a little bit as well as some of these patients want to get their drug before some of the burner.
Fifth our reset copays and deductibles in January so that always impacts its not just preferred apps, but it's for the industry in general that's what happens in Q1 also for gross to net the accrual percentages always higher so you accrue the Medicare manufacturing rebates for all Medicare pays.
<unk> into Q1, and then gross to net will well.
Paul a little bit off throughout the rest of the year. So that's why you see inflated gross to net and in the first quarter.
And then and I already also talked about the reauthorization process, but during that reauthorization process that for the most part happens in January .
We are we provide bridge shipments for these patients so that they don't have an interruption in any of their their medication.
Those are the seasonal factors that we have as well as again like I mentioned all the other products in the industry it impacted but for the most part in the first quarter.
Yes.
Yes.
John .
That's typical especially in the specialty pharmaceutical area.
And where you're dealing with.
One specialty distributor.
And as Jeff pointed out.
There.
We gave away because on the bridge shipments we can't charge for the that's for.
Free of charge to patients that are waiting for reauthorization.
It's pretty typical in the business and so that delay can be anywhere from a week to three weeks getting that reauthorization in which you are not only giving away free product, but youre, giving away revenue if you will so.
And I think if you look back at us historically.
With a few exceptions, you'll see that Q4 versus Q1.
Sort of flat.
There are exceptions like in Q1 of last year, we on boarded a number of the reserves you patients so that was skewed.
So, but otherwise its pretty typical.
And I'll leave it with this is once again like we've said throughout the.
Our call today, we confirm our forecast and guidance.
<unk> apps as well as site count before 2003.
Given the strong performance with <unk>.
Start ups revenues in Q.
That's very helpful. I understand the impacts in the industry wide and I just wanted to get a sense of it.
Same for you thought there was something else. So just thank you for the explanation on the details.
Regarding just I guess, you've touched on the guidance. It has there been a shift in the mix of the guidance or is that still the same as you provided last quarter for that.
For the separate product line.
Yeah right now there's no change in the mix. The proportion is the same as we talked about last time less.
Got it Okay, and then if we normalize by comp.
For the.
Full three months run rate.
That would imply a very strong quarter, I mean, probably more so than what everyone expected that say.
Can you provide any color that you think drove that upside and can we expect the remaining quarters to be similar any strong I mean, if we do it with like a normalized run rate something around $40 million per quarter.
Does that seem reasonable or is that a high number.
Yes, that's a great question and I'll, let Jeff take the swell.
One one quick thing as with any integration you have to allow for a transition period.
What we're doing is we feel like we're going to be much more efficient with our sales force.
We are taking about 40%.
From a size perspective, our number of field personnel versus what was previously used.
As for five Tampa and larger territories, but with that we want to allow for that transition period.
Period to take hold and that's why we're very confident in the flat to 2023 versus 2022.
Let me add to that.
As Jeff pointed out in your earlier question.
It is more of a retail product.
As a result.
<unk> here.
You know your rebates in your re authorizations and things like that also are reflected in the month of January and so I don't think you can merely take those two months and extrapolate for the full year I think that would be.
A mistake and I think right now for the moment.
That changes, we'll certainly provide an update on the guidance, but I think that we're still very comfortable sitting with that $1 30 for this year.
Correct and we are very confident that we can demonstrate growth in 2024 with <unk>.
Hello, guys. Thank you for the color.
Good luck on the progress thank you.
Great. Thank you.
Thank you. Our next question is from Joe Catanzaro with Piper Sandler. Please proceed with your question.
Everybody. Thanks, so much for taking my questions. Maybe first one for me just wondering if you could comment on the cadence of new patient enrollments in the quarter and the split you're seeing between non tumor lemons and tumor lambs and whether that dynamic is changing in any way with some of your efforts.
<unk>.
And then with regards to your comments on you know further global expansion opportunities wondering if we should think about that in the same way you sort of struck a collaboration with dyno in Japan, and then maybe related to Dino are there any milestones associated with the completion of their phase III and then subsequent NDA filing.
Yeah.
Sure.
Do you want to take that.
The first question Hi, Joe Thanks for the question.
The cadence of new patient enrollments in Q1 exceeded forecast.
So we had a strong new patient enrollments there in Q1, and we continue to see that.
That's strong cadence here, thus far in Q2.
As far as the mix goes we saw and we estimate about a 25% of our new enrollments in Q1, our tumor landscape.
Keep in mind that some patients come in with that tumor lens.
10 code, but there are some patients that come in that are relapsed patients and then over so we have to make an assumption. So over the next two years as they get their scans a will be diagnosed with it.
So based on all of those factors, we are estimating that we're about 25%.
The mix of our total enrollments are two months.
And Joe with regard to our global efforts.
<unk>.
The dialogue pharma transaction for.
For Japan serves as a really good model for other territories.
In Asia in South and Central America.
And.
With regard to milestones there is undisclosed.
Millstone based on our filing and accepting <unk>.
Okay got it that's all helpful. Thanks for taking my questions.
Sure sure.
Thank you. Our next question is from Charles Duncan with Cantor Fitzgerald. Please proceed with your question.
This is Pete stavropoulos on for Charles Hi, Pat and team.
Congratulations on all the progress for the quarter.
First question is.
Is that there is greater than 800 diagnosed patients.
They're being treated with first apps, but wondering what you can say or what that number suggest in terms of penetration into the total lambs opportunity and are there any specifics you can give into penetration as a result of the oncology outreach efforts.
I'll turn that over to Jeff.
So what we're seeing right now is about a 25%.
Penetration.
Of current patients that are still living.
And diagnosed with lung so that's what we're seeing is about a 25% penetrated.
As far as.
Your what was your other question Pete about about that and with the tumor patients. What we think we can get as far as penetration.
Yes, sorry, it was actually I was asking what do you think the oncology efforts outreach efforts has been impacting.
Okay excellent and what I can say there is the.
The unfortunate news for small cell lung cancer patient that 80 greater than 80% of these patients are undiagnosed.
And so it's up to us to help these patients get diagnosed so that they can get a benefit from the treatment with start ups and so we've seen an uptick recently, just a slight uptick in 25% or so.
Into the percent of our new enrollment center small cell lung cancer limitation, but we're hopeful that we can get to about 30%.
The mix will be the tumor lapsed patients. So that's what our all our efforts are geared towards.
Okay, and you know all of the patients on first apps. You know can you provide any you know are the proportion of off or any color about how patients who would like to go from from 80 milligrams and be up those 200 milligrams.
Yes, right now there are 40% to 40% of our current patients are on 80 milligrams or higher.
We know that lens is a progressive disease and also from hearing from patients and physicians and from former recertification and were higher that patients will benefit from a higher dose some of these patients. So.
So we feel like there will be.
That's a huge benefit again to these funds patients also we do see some physicians that patients that don't want to go to the Max dose. So when you have a cap of 80 those patients that are at 60, or even 70 milligrams don't want to go to 80 milligrams, if thats the Max dose.
So now having 100 that allows for some of these patients to also benefit from a higher dose if that's what is necessary to help treat their therapies.
Alright, Thank you and one question I guess on a comp so it's.
What's the potential for developing if I kind of put in the rare epilepsy indications and if I heard you correctly, you mentioned earlier in the call bad.
Epilepsy.
Logging into a precision medicine approach you know are there any specific epilepsy do you believe if I can't but can be utilize them.
Well there have already been.
Seven different rare epilepsies that were identified in our recently published paper that we did a press release not too long ago.
With regard to other rare epilepsies that may develop.
The current label for for copper actually contains a fairly broad description of of clinical characteristics of epilepsies that can be treated with the drug specific.
Specific rare epilepsy.
<unk> presents with those clinical characteristics that physician will be able to prescribed by comp are on label for that rare epilepsy, and determined whether or not the patient responds well to that but as I said there is already seven that had been identified because of the relative maturity of this product we do not anticipate doing any formal clinical trials two updates.
Our label to specifically call out specific rare epilepsies, but our team of them ourselves. We will continue to provide any information that is relevant for the treatment of rare epilepsies to the physician community.
With like all of us.
Okay. Thank you for taking our questions and congratulations on the quarter once again.
Thank you Pete.
Thank you there are no further questions at this time I would like to hand, the floor back over to Patrick mechanism for any closing comments.
Yeah, I'd like to thank everybody for joining us today, and we look forward to our next earnings call have a great day.
This.
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