Q2 2020 Catalyst Pharmaceuticals Inc Earnings Call
[music].
Hello, and welcome to the coldest pharmaceuticals second quarter 2020 results.
At this time, all participants are in listen only mode.
I did want to require operator assistance. Please press star zero under telephone keypad. A question answer session will follow the formal presentation. As a reminder, this conference is being recorded its called my pleasure control over the Elie Radinsky Oh. Please go ahead.
Good morning, everyone. Welcome to today's conference call joining me on Playskool ambitions, Italys team, including Patrick Mcinerney, Chairman and Chief Executive Officer, That's just do Emily Chief operating officer acute scientific officer, there Gary engine Ito, <unk>, Jude medical and regulatory officer, Jeff.
Okay, I mean, chief commercial officer.
Before we begin I would like to remind you say the phone call. My name. The Q any session. We will make statements about expected future resorts, which maybe forward looking statements for purposes of sales decreased about.
These statements relate to a current expectations estimates and projections are not guarantees of future performance.
They involve risks uncertainties assumptions that are difficult to predict.
I mean, there's not too, yes, right, especially in light of probably my team.
Actual results may vary.
Looking statements should be considered only in conjunction with a detailed information contained.
Filing.
This afternoon, describing our 2019 I don't report on form 10-K.
This silent on that the coal into that.
Thanks, Alex.
And thanks, everyone for joining us this morning first second quarter results from business update call.
Oh that everyone is things shaped unhealthy, Germany is unprecedented in challenging times.
We have a number of items to update you on this morning I'll start with how pleased we are but the second quarter financial results were achieved.
Despite operating under very difficult conditions on the Coca 19 environment, we manage to generate $29.6 million had net revenue and net income of 9.8 million, which included noncash stock based compensation expense of $1.8 million.
Additionally, we ended the quarter with $115.1 billion, who cash and cash equivalents had no funded debt. How he will provide you with more financial details in a few minutes.
I want to emphasize how proud I am up our teams ongoing effort to demonstrate their steadfast commitment to the patients. So we serve.
They have shown a remarkable resilience and ability to continue to expand the number of patients benefiting from firdapse to treat Merrill Lynch condition.
<unk> was 19 continues to make it difficult for patients who may have lambs and have not received a definitive diagnosis from their position because of their inability to schedule.
Concerns about in person meeting with their position.
That's had an impact on the number of patients enrolled in catalyst pathways.
As we had previously anticipated travel for our sales representatives to physicians offices continues to be mostly restricted by the pandemic.
Having said that our base of adults.
Then patients remained solid and intact as we add new patients, albeit at a slower pace than we projected before the same dynamic.
We are resolute in our decision at the beginning of this year to double our field sales force and you had or inside marketing support team to assess catalysts outreach to physicians and patients suffering from rounds.
When the effect of the covered 19 pandemic are behind US I believe that we'll see that we're well positioned the company for future growth.
Jeff will provide you with more details on our commercial operations momentarily.
We were extremely pleased to announce this morning, Ted yesterday, we received a notice of allowance from U.S. patent and trademark office for our pending patent number 14, 128 672 for a methods of administering three four domino parenting.
I pod pay was a patent issue feed for the pattern.
Sure issue within six eight weeks this patent when issued by U.S.P.T. O would have the expiration date I've no earlier than June 29, 2032.
The expiration of this patent could also be extended based on delays and patent prosecution if any.
Yes extension, if any will be calculated after the patent has been issued.
This pattern will further strengthen and reinforce our exclusivity or the Firdapse brand in the United States will continue to attempt to add value to catalyst and all of our various stakeholders by further enhancing our intellectual property portfolio folio.
With regard to our clinical development programs. We're obviously very disappointed that we did not achieve positive that's care results with the M.S.K.
002 phase three study of Firdapse as a potential treatment for musk antibody positive my cidade grab those patients.
Based on our review of topline data. Unfortunately, this study did not replicate the robust efficacy results. There were seen in our proof of concept study conducted in Italy, we.
We've just recently received final.
Statistical output.
And are continuing to analyze these final data and findings with our neuromuscular advisors.
So did to decide on whatever path, we will be going forward for this program.
For it actually showed a significant and differentiated treatment benefit for limbs patients and we will continue our development efforts to bring this much needed medication to patient suffering with other rare neuromuscular conditions. When we who are currently today without any approved therapy.
Steve will have more to add one who reports on our R&D activities and other clinical programs.
As previously announced we have promoted Jeff Joe Karma to Chief Commercial Officer, Jeff is responsible for leading sales marketing and commercial operations as we continue our Firdapse watch execution through this unprecedented time.
Jeff is proving is going to be by leading the sales and marketing team that successfully launched firdapse in January of last year for the treatment of adult men stations, but then the United States.
Jeff's leadership and experience catalyst as well positioned for sustained success as we continue to expand access to hurt absent olin's community.
As well as prepare for potential launch of Firdapse for other treatment of patients suffering from other rare neuromuscular diseases.
Last week, we also reported yet our marketing authorization prefer apps to treat lambs was approved by health Canada.
We believe that the commercial opportunity in Canada is about 10% I'd be U.S. prevalence of LEMS patients.
We're excited about providing a health Canada approved drug programs patients, while expanding our global footprint, where their neighbors to the north.
We're currently in final discussions with an established Canadian marketing and distribution partner and expect to finalize our agreement in the during their future.
Several weeks ago, we've met with the Pharmaceuticals, and medical device agency or PMB, a regulatory agency responsible for approving drugs and Japan to discuss the clinical and regulatory requirements for gave me an approval or Firdapse for 11 stations.
I believe that we have an agreement.
So a reasonable and efficient program to gain approval in Japan.
We are in early discussions with several potential sales and marketing partners in the territory.
Stable have a little bit more to say on that program shortly.
As you can imagine we're very disciplined over three important recommendations filed by the magistrate and our lawsuit challenging GFT A's authority. So proved reserves you. Despite our orphan drug exclusivity for Firdapse [laughter].
For context, however, I want to stress that the interim reported the magistrate tennis recommendations is by no means to is positive and final decision lies with the district Court judge.
Our next step in the process to file our objections to the reporting recommendations and our attorneys are harder work on that and expect to documents to be filed this week.
In other words. This has been just the next step in the process has given us an opportunity to provide further focus on the legal issues, we see us be paramount in our case, we still expect a final decision in this case sometime later this year.
I'll now turn the call over to Jeff Delcarmen, Our Chief Commercial officer, who will provide you with an update on our commercial operations.
Thank you Pat and good morning, everyone.
I'm very excited about the opportunity coming at the catalyst commercial team and continue the success that we've had since launch.
As we previously shared cobot 19 has impacted certain aspects of our commercial business.
However, we continue to drive key areas of our business forward.
Mid March we announced the suspension of all travel face to face interaction.
To ensure the safety of our team our patience in all health care professionals.
Some areas of the country appear to be starting to open up we're still seeing and greatly reduced number of land patient office visits.
Well stations have been rightfully worried about venturing out the hospitals and physician offices.
Anything other than emergency care.
As a reminder, Latin stations had two separate key risk factors, making dense susceptible to severe cobot 19 disease.
They are often over the age 60 and have weakened immune systems.
We have adjusted our approach significantly we continue to support our patients caregivers in health care professionals. During a time that requires flexibility and willingness to do everything necessary to support the lens community.
Despite these obstacles.
Our second quarter 2020, net sales of 29.6 million.
Represents an increase of 3% over net sales in Q2 2019.
This is a significant achievement considering Q2 2019 with prior to the commercial availability of reserve.
Well as the co the 19 pandemic.
I'm proud to say that we now have over 600 patients.
That have received the firdapse prescription since launch.
Our new patient enrollments were slightly lower than expected in Q2, we continued the positive trend of strong medication compliance and persistence.
90 day discontinuation rates have continued to improve from last quarter trending to around 15%.
Since the end of January we see Discontinuations or is there GE has slowed significantly.
In fact June Discontinuations were the lowest monthly total.
April of 2019.
I'm extremely pleased with our commercial teams ability to deliver this result, despite the significant challenges we faced.
Based on early observations in the third quarter. We believe this strong performance will continue into the second half of the year.
In July.
Patient enrollment approached pre covert 19 level.
We feel that there is pent up demand specifically.
Ill patients that are diagnosed with lands that are not yet on fair that that will be prescribed firdapse. Once these patients are able to visit their healthcare provider.
Also among our existing base a patient.
Clients and adherence remained very high.
Discontinuation rate remained low in July.
Our catalyst athletes patient services team continues to do a tremendous job responding today should be.
Doing everything possible to support our patients and physicians during this period.
We reiterate our confidence in our supply firdapse for the length community and we are happy to report that no one patient.
Has gone without medication.
Well documented concerned that rare disease patients have at this time.
Prescription approval rates remain around 90% across all payers.
Lynn or private commercial insurers are financial and co pay support programs continue in full force.
Patients enrolled in catalyst pathways, including those who are covered by Medicare and accessing foundation assistance have an average co pay of less than $2 a month.
We are also happy to see that Cobot 19 has not significantly increased the number of adult LEMS patients on firdapse.
Got it needed to transition to Medicaid or our patient assistance program.
Our customer service levels and ratings continue to exceed expectations.
Further validates who we are as a company and how we always focused on doing what's right for patients.
Despite the challenges posed by the pandemic, our regional account managers patient access the eight health and medical Science Liaisons has done an excellent job being a valued resource for both healthcare providers lends community.
We remain confident that are updated commercial strategies field force expansion inside sales lead generation of communication effort.
And expanded non personal promotion to healthcare professionals in Illinois community will successfully positioned the team for growth in the second half of 2020.
While these are challenging times, our team is committed to making firdapse accessible to all adult patients with lands.
I'll now turn the call over to Dr., Stephen Miller, our Chief operating officer in Chief Scientific Officer for an update on R&D activities Steve.
Thanks for the commercial update just I will now provide an update on our clinical pipeline to develop firdapse for additional neuromuscular indications first I will turn to our phase three clinical trial results for emulex KMG to evaluate the safety tolerability and potential efficacy of Firdapse for the symptomatic treatment these patients yesterday.
Today, we announced topline results from our phase three clinical trial, I must say owed to evaluating firdapse for the treatment of adults within their list.
As previously stated its based on our review of the topline data from the trial statistical significance for the primary endpoint of my senior gravis activities of daily living score or MG ideal was not achieved nor was it achieved for the secondary endpoint of quantitative my senior grab a score or two mg.
With P values of 0.220 0.37 for each of these on points respectively.
This trial was a multi site international trial conducted in the United States, Italy, and Serbia. It was double blind placebo controlled clinical trial conducted under special protocol assessment would be asked yet.
Trial enrolled more than 60 analyst antibody positive patients, but also enrolled more than term anti acetylcholine receptor antibody my sumit gravis or a Chr mg patients.
Who were assessed with the same clinical endpoints, however, achieving statistical significance in the subgroup of patients was not required by the protocol.
Additional details of this trial are available on critical clinical trials start growth.
Naturally we are disappointed by these results and even surprised given the results seen in the proof of concept study.
What's lumps population Firdapse was safe and well tolerated in the EMEA was KMG patient population on a positive note. The emulex KMG patients, but ultimately were randomized showed a clinical improvement of 5.3 points on the Mg radio scale during the six week running period prior to randomization.
A two point improvement or more is considered clinically meaningful. So this mg radio decrease represents a significant clinical improvement in the patients condition. During the run in period of the trial for 47 of the 55 randomized Mewas KMG patients who participated in the trial continued to be.
Open label extension study and a preliminary review of the unlock data from that study indicates that.
The significant improvements seen during running continues into the open label extension demonstrating to us a durable clinical effect.
Our analysis of all the trial data is ongoing I mean in near future. We will be meeting with several of our newest KMG to opinion leaders to discuss the results we factor patients and their families for participating in this trial and also the investigators for their dedication to this important clinical research catalyst plans are making a complete analysis of all trial.
Data available at a future medical meeting or in a future publication.
The second trial I would like to provide an update on is our proof of concept study in SMB type three which is ongoing in Italy, and Servier, obviously evaluating the safety tolerability and potential efficacy of them separately for the symptomatic treatment of estimated type three in ambulatory patients.
Estimate is caused by related genetic defects to the some and protein and motor neurons. This initial proof of concept study as a crossover design with a two week treatment time in each period and is designed to measure changes and some a disease symptoms for walnuts study disease progress.
SMB type three has an estimated prevalence of between 2000 903600 patients.
It is important to note that all four types of vessel may or caused by various another key effects to the same gene the codes for the us some improved resulting in variations in severity, which are broadly characterize as estimate types one two for.
This is proof of concept study is successful catalyst intends to discuss the design of a multi center phase three clinical trial with the FDA, which we intend to address those symptomatic treatment and disease progression and perhaps more than one type of vessels.
Covered my team restrictions did cause a delay in starting we estimate trial in Serbia, but those restrictions have now been listed in the last patients are enrolled and actively participating in the study and we anticipate reporting topline results from the study by the end of year.
Moving on to market expansion plans for Firdapse catalyst Canadian MD us for the symptomatic treatment of loans was approved in early August of this year, we anticipate having Canadian labeled products complete.
Depleted and ready in the near future as was previously discussed catalyst is actively seeking a marketing distribution partner to market Firdapse in the Canadian market.
Catalyst is also continuing to market expansion activities and the territory of Japan. As was previously reported covered my team delayed or meeting with the Japanese pharmaceuticals, and medical device agency or PMT.
So Q3, but I can now report that we have complete the meeting have reached a tentative agreement on a regulatory pathway to seek approval of Firdapse in Japan.
Tablets will be conducting a small clinical trial in Japanese subjects and the details of the trial will be made available at a future date when registered on the Japanese National Institute of public Health registry of clinical trials website.
Fortunately three years ago, the Japanese government designated the approval of Emmis equity and as a priority drugs for the Ministry of health Labor and will offer or am I still don't.
And they have been actively soliciting companies to develop and file and MBK for this drug.
Due to the fact that this drug is a priority for the Haynesville Dover do they have been helpful. Uncooperative in this process to formalize the regulatory path to seek approval of Firdapse in Japan.
Patients have long.
Requested a long acting version of Firdapse in order to eliminate the need to clamor daily activities around multiple doses of Firdapse. We're now actively developing this new product and will provide updates in the future when the product characteristics have been finalized at this stage of the development program is variety of targeted the formulations have been developed.
And their drug release properties are being studied in order to optimize the long acting symptomatic treatment of works.
Thomas will also be supporting investigator sponsored proof of concept studies in the near future for additional neuromuscular conditions to be evaluated such as to how does this disease hereditary are obviously with liability to pressure pauses or it's a few treats and possibly others.
As the plans for these trials are finalized catalysts will provide more details about the trial design disease prevalence and timing.
Moving onto intellectual property Pat described the recent allowance of our pending patent message of administering three for Diamond appeared this patent claims a method of treating a human patients diagnosed with through four.
Diamond appeared insensitive disease by administration for dashboards salts to slow settling patients having certain mutations in each a wheel hub in that two Gee. We're pleased that a patent for this discovery that was made by the Firdapse developments in many years ago as fundamental out and we believe this pattern will provide additional protection for the for.
Thats product franchise.
This extended period of product detection will from the catalyst to carry a research a new uses and product improvements for years.
Upon issuance catalyst intends to list. This patent EMEA is warrants book with an expiration date of at least June 29, 2030, so upon being listed in the Orange book No generic equivalent of Firdapse, maybe approved by the FDA unless the generic drug application can prove that they do not infringe the listed pad or until the African successfully.
Colleges the validity of list.
In the first half of 20 twice the Cobot mentioned health emergency has little effect on our R&D programs with only minor delays to the U.S.K. Mg estimate and the long acting Firdapse programs and there has was no effects on the commercial production.
However, the Kennedy's disease in ancient Pp programs are investigator sponsored studies that were delayed by several months due to academic institutions related restrictions that are now being lifted catalyst anticipates efficiency programs will be resume this fall.
Despite the challenging time environment due to covert my team and the impacts of the global Health crisis is having an has had on our timelines we remain extremely committed to our research programs to evaluate firdapse for other neuromuscular indications. Additionally, our current supplier firdapse for patients with labs and for ongoing clinical trials has not been.
Affected by covered my team.
Overall, we are excited about the opportunities to expand the current firdapse label into additional indications as well as an additional countries and to develop a better product for all these patients we will provide any updates on these clinical and regulatory pass as they become available I will now turn the call overtime demographics, our chief Financial Office Officer today.
View, our financial results since the.
Yesterday, we filed our second quarter 2020 form 10-Q, and reported GAAP net income of 9.8 million or nine cents based on that at a share compared to GAAP net income of $11 million oil 11 cents per basic and 10 cents per diluted share.
Thank you have 2019.
For the second point have 2020, non-GAAP net income excluding 1.9 million of expenses related to non cash stock based compensation, what's the 11.6 million for 11 cents per basic and diluted share.
In comparison to second quarter 2018, non-GAAP net income.
Excluding 925000 of expenses related non cash stock based compensation, but 11.9 million 12 cents per basic and 11 cents per diluted share.
Revenue for freight absolutely 29.6 million for the second point of 2020.
We did it cost of sales of 4.1 million.
Second quarter 2019, net revenue from freight EPS was 28.8 million related cost of sales in the portion.
4.3 million.
What do you remember that gross margin in both at 2020 and play 19.
Can you to that some of the inventory manufactured and expense prior to the FDA approval.
Research and development expenses Swift Wifi million for the second quarter 2020.
Compared to 4.6 million for the second 2018.
Research and development expenses for the second quarter of 2020 were in line with dose of the second quarter 2018, and primarily consisted of expenses for medical and regulatory Affairs high quality assurance program expenses from our ongoing freed up sinful Trauson study.
Cost for our expanded access programs.
We have been that research and development cost will continue to be substantial complaints when we consider our ongoing as we can team I ongoing technical trials on studies understate empty and estimate Thanksgiving continue expanded access program.
Let me add things limitation proliance affect us began to move forward with every flight clinical study evaluating freight upswing achievements of lamps in Japan and begin to evaluate Esa treatment for other analysts that ADCC.
Again expenses for the second part of 2020 totaled 10.8 million compared to 9 million in the second quarter 2018.
The increase when compared to the same period in 2018 is primarily attributable to the expansion.
Salesforce in the first quarter 2020, including related non cash stock based compensation the cost of additional supporting personnel.
The cost of contracting with everybody sees Steven infill sales agent.
We expect that DNA expensive, we'll continue to be substantially in 2020, as we continue to be on first our infrastructure and commercial and patient programs in support of the expansion of our sales activities referred us.
We continue to pursue I lawsuit against the FDA.
On June 30, 20 claim catalyze had cash and investments.
115.1 million I know funded that.
Ladies and information and analysis, maybe in the company's quarterly report on form 10-Q.
Which was filed with the Securities and Exchange Commission yesterday other sense.
Dan.
The Investor Relations page of our website.
You, though you, though that federally pharma dotcom.
Now I'll turn the call or is that.
Thanks Sally.
I just want to reiterate how pleased I am with the operational results that our team has realized during 2020.
We look forward to continue our effort to assist adult lens patients and their treating physicians to find their way to an FDA approved therapy for this debilitating disease.
We will continue our efforts to study firdapse for other rare neuromuscular conditions that are without an effective therapy as well as advancing our work when I am more patient friendly long acting formulation of hurt apps.
This morning's announcement regarding the notice of allowance for our pending pad is very important as we continue to invest in firdapse has the potential therapy for other rare neuromuscular conditions.
Lastly, we are excited to see our global footprint expand as we gain approval in Canada and continue our efforts to prepare to seek approval in Japan.
As well as our concerted effort to bring other molecules and door companies under the catalyst umbrella.
And with that we'll open the line for questions operator.
Thank you would that be conducting a question answer session. If you look to be placed on the question Q. Please press star one under telephone keypad, a confirmation tone will indicate your line is in the question Q you May press star to if you'd like to move your question, probably Q for participants using speaker equipment and maybe.
As a starting to pick up your handset before pressing star one one moment, please what we pull for questions.
First question today is coming from Charles Duncan from Cantor Fitzgerald. Your line is now live.
Thank you.
Thanks and team thanks for taking our questions and congratulations on the commercial performance during this very challenging year.
Thank you Charles.
Yes, so had a couple of.
Questions on the commercial side, then and then one on the pipeline the future.
With regard to net revenue impressed with that given the challenges of co bid, but I'm wondering if you could determine dilute that little bit and and talk about the impact of new patients versus persistence and was there any pricing action.
In the quarter and then I wanted to ask you follow up regarding the size of the sales force.
Sure, Jeff you want to take that.
Yeah no problem.
As far as new patient enrollments for the quarter, we're not giving out exact numbers that they were slightly lower than.
We had.
Forecasted.
The positive side is we really focused on patients that were already diagnosed.
Not yet on Firdapse and we have a strong analytics team here. It provides us those leads.
And our sales force goes out there in has those discussions with the physician and however that position in the often want to engage we are ready to go with virtual engagements or life face to face if that city or that institution allows.
And so that's where we're we've been able to help those patients get enrolled in by identifying those patients and as far as the Discontinuations like I mentioned, Charles we significantly.
Stabilized the Discontinuations and we're seeing about 15% of patients now on to 90 day patients that are discontinuing. So we had a strong month quarter that on that side as well.
Charles on Jeffrey Jeff.
Let me just add that we did gain new patients in second quarter and without being specific as you know as a challenging quarter and we did say.
When we.
At our Q1 results call, though we were withdrawn guidance because we just didn't know what was going to happen the rest of year.
And.
Pleasantly surprised that new patient enrollments dead growth, albeit not at the pace that we had predicted our early in the year when we gave guidance.
But we more patients are continuing in Q2 and so far in Q3 two have.
New naive patients having access to an FDA approved therapy, and Firdapse and with regard to pricing there was no.
In Q2, there was no.
Our actually this year Theres been no change in.
The price of Firdapse.
Okay, that's helpful and to Jeff I really appreciated all the operating metrics that you shared regarding the size of the sales force.
Feel like it's rightsize, now and and I guess it to two results.
Nice nice to see but do you feel like Salesforce, who is fully operational there or is it really kind of the perhaps a second half the year impact, where we see them being able to get out and.
And tied to new prescribers are deep in the prescriber interactions.
Jeff.
Charles Fantastic question in.
The first thing then I'll stress is we have not seen the full impact.
Our expansion.
We hired such experienced sales represented regional account managers, we call them here.
And we do feel this is right sized and we feel like I mentioned that there is a pent up demand.
And.
The reason why they are still making are providing value.
Because we find lead.
Whether it's from inside sales.
Whether it's from non personal promotion.
Ultimately the regional account managers that are reaching out to the healthcare providers to discuss.
Firdapse, it's appropriate for that patient and that's how the patient ultimately gets enrolled.
So we are seeing a benefit we feel the 10 is rightsized and we are excited about the future because we know we have yet to see the full impact.
On this chemo have won the country open it up.
Let me just that let me just add to that Charles essentially no.
Early this year, we basically doubled the size of our field sales force, we brought onboard and then side.
Marketing support team.
That assists, our ramps are regional account managers and.
And so that that was completed actually in February in early March and of course, we all know what happened in March and for the no no travel ban or were they travel ban I should say and so.
Yes, it's been challenging a difficult because let me tell you these regional account managers.
Want to get out there and they want to assist patients in finding it approved therapy and so it's been challenging because the meetings for the most part of than virtual they've been on teams are zoom are just telephonically and what what's exciting is that just very seasoned team.
Has in place as things turn around we're going to really see the traction we gained by doubling that salesforce and bringing on board the.
Inside marketing as supporting.
That makes it tough sense, if I could just asking question on that on the pipeline either either for Steve or or Gary.
Okay.
Thinking about that MUSC empty result, and I'm, a little surprise as well given the randomized withdrawal.
Protocol design and the and I think you said there is an average of five point in improvement.
During the first first part of it in the run in Phase of this study so.
So I'm wondering if you've been able take a look at patient level data and if you've identified any outliers are patient heterogeneity that would.
Cause you to think about this result is being perhaps not the result of an ineffective drug but the result of.
Trial that was somehow compounded and then what what you would see as potential next steps.
It's the latter.
Okay. Thank you for the question Charles.
The as you point out the data is somewhat paradoxical with.
What appeared to be.
Hey, good clinical improvement during running big that lack of statistical significance and the randomize portion of clinical trial.
This is topline data that we've only received a few days ago. We haven't had time to go through all the patient data in detail. Our analysis is ongoing and part of that analysis. Once we work through will also be to meet with our key opinion leaders for us to try to get a better understanding of exactly what happened in this trial and once we have a clear.
Understanding both among ourselves and our two opinion leaders, we will be deciding.
On what the ultimate future the program is.
Okay last question for Pat sorry for all the questions.
Congratulations and the new IP I'm, a little surprised about that because I don't think we've ever really talked about that perhaps have overlooked it.
Our diligence in the past that I'm kind of wondering what what are the key claims or anything in particular that you could highlight about that.
And do you feel that that this particular Pat.
Has if you will.
Resiliency in terms of any any challenges and does it does it change your perspective on investing in the Firdapse franchise.
So Charles.
We right now we can't speculate on how it made sense any particular company or program.
Other than we believe that our pattern is strong and we'll be very enforceable against any potential generic competition.
With regard to the claims you know maybe Steve can you give you a high level look.
That that.
Notice of allowance in the patent.
Claims are listed by the way.
Steve.
As we said in our press release the claims are centered around.
The method of use of the drug to treat step sensitive disease in patients that are slow acetyl letters that have certain.
Defects to the.
Legal that codes for the settle transfer is tied to June.
At this point I can't comment on any strategies or how we might actually implemented the defensive those.
Our claims, but we feel that overall, it's a useful and we do intend to ensure that to the degree that it makes sense to defend our intellectual property.
Thanks for taking my questions congrats on the quarter.
Thank you Charles.
Thank you. My next question today is coming from joke zero from Piper Sandler Your line is alive.
Hi that this Charles on for Jeff Thanks for taking my questions.
First question guidance.
And if or when do you plan on reissuing 2020 guidance.
Yes, that's a great question Joe Thanks for the question.
When I think that when we get more comfortable with what the rest of this year is going to look like.
Hopefully.
This pandemic.
We will be for the most part behind us by the end of next year or early Q1 or two till next year, but it's still too early for us at this 0.2 to provide guidance or actually be able to to state. When we will be able to provide guidance again, just based on the fluid nature.
This disease and the pandemic so.
No. It's at this point, we're not prepared to say when we will be able to provide guidance.
Okay got it.
Just looking for some.
Quantitative firdapse metrics.
Would you be able to say the total existing reimbursed patients on therapy at the ended the quarter.
Well, we'd be able to say that.
Yes.
Could you could you are you able to provide the number of total reimburse patients on firdapse at the end of Q.
Yes, we've just some of these metrics that we provided early on were very important as we launched the drug and we in the past two quarters, we've pulled back.
On providing all the metrics that we previously provided.
And feel that.
The variance from quarter to quarter can be too.
Too much emphasis on a particular metric so we're more comfortable with given guidance that are that are.
The.
The number of enrolled in patients Undrawn.
Reimbursed strike is growing and.
That's that's about the extent of the guidance.
We're per paired to provide or metrics over.
Prepare to provide at this point.
Okay.
I understand.
To the extent that you're able to talk about MUSC Mg data in any detail at this point.
Wondering where exactly that trial failed in the randomized portion.
More that that placebo score it can change and that the firdapse Corey and JBL steady.
And then what could have potential path forward look like.
Joe It's a little too early for us to give any details about.
How the specific response came out in the two treatment arms of the studies, we're still analyzing all the data we will have more to say about it in the future. After we completed the analysis.
Okay. Thanks.
Last question on the patent.
Could you explain in some greater detail.
How exactly.
A patent covering.
Hello.
Phenotype for that too.
Translates to broad patent exclusivity for using required to happened as patients.
I guess in lens and potentially indication the on levels.
You know, Joe you're asking a question about.
Regardless of enforcing the patent and I just can't comment on it.
Okay. Thanks, Thanks for taking my question.
Thank you Jeff.
Thank you next question today is coming from Leland Gershell from Oppenheimer. Your line is alive.
Hi, good morning, Thanks for taking my questions and.
Good.
The execution during the the challenging quarter.
Hi, David a question on on just as you have the discontinuation rates.
We understand correctly, when you mentioned, 15% or so with a 90 day discontinuation rates does that include patients who are.
Switching off to reserve be or is it simply patients who have discontinued three four dep therapy.
With regard to switches to to reserves are those patients primarily patients who had been on his or D. And then when on Firdapse undergoing back or is it also a mix of new patients who hadn't been treated going on firdapse, but then for whatever reason opting to go unreserved follow thank you.
Sure, Jeff you want to take that question.
Sure. The then did 90 day.
Discontinuation rate of 15% does include reserves.
Any patients that does continue to go to research.
Okay.
In the linear your other question.
Could you repeat that second part of it.
Yes, just so we have sort of a handle on switches from firdapse and want to understand if the patients who are switching from firdapse are those patients who had previously been on.
Reserve DNR or for whatever reason going back on or is it new patients.
Coming onto therapy for the first time, who.
May want perhaps dosing flexibility that was there could you provide just that we understand what the.
What the components of switches are going forward as more patients as the mix shift to more patients who had not previously benign any then it before debt formulation. Thanks.
Sure. So the new enrollments that we are getting right now none of those patients.
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Immune into first quarter, we saw a couple of patients that had does that were previously on a three for that.
But since the first quarter, we really haven't seen any patients new enrollments that were on three four down so what we call naive patients. So naive to three four down that those are the patients that we've seen that are newly enrolled.
Okay. Thank you.
And then a question just on the Japanese opportunity would you be able to to help us understand what the potential patient population.
With lens that treatable with with Firdapse would be and.
Any timelines you could share on.
When you might be.
Able to be approved there. Thank you.
Sure.
In regard to the patient population.
The.
It's a Japan is about 40% of the US population and as you know up.
Vast industrial economy, and so the patients have access to medical care, just like our western Europe in the United States. So I would anticipate that.
You can just use above 40% of the U.S. numbers.
For to model, Japan with regard to timelines, it's too early for us to say, where we haven't disclosed anything publicly about overall timelines at this point.
I might add.
That we do expect orphan designation.
And this and that would come with a priority review.
So there is an interest.
Image shell W to get this drug approved.
As quickly as possible for the Japanese population.
Alright, great well, thanks, very much taking the questions and congratulations.
Thank you lately.
Thank you we reach of our question answer session, let's turn the floor back over to management for any further closing comments.
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