Q1 2020 Earnings Call
[music].
Greetings and welcome to the catalyst Pharmaceuticals first quarter 2020 results conference.
At this time all participants are in listen only mode. A question and answer session will follow the formal presentation.
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Pleasure to introduce your host with all the Gordo CFO thinking you may begin.
Good morning, everyone and welcome to at least Caltrain School.
Joining me on to leave school I remember some of the kinda listing, including Patrick Mcinerney, Chairman and Chief Executive Officer, Dr., Stephen <unk>, Chief Operating Officer, Chief Scientific Officer in the third Gary engine Ito, Chief Medical Officer, and head of regulatory Affairs, and Dan Brennan Chief Commercial officer.
Before we begin we'd like to remind you that in the following comments and in the Q1 a session. We will make statements about expected future results, which maybe forward looking statements for purposes of federal Securities Law.
These statements relate to our current expectations estimates and projections.
Not guarantees of future performance.
They will risks uncertainties assumptions that are difficult to predict a nice true not to be a jury.
Actual results may vary.
These forward looking statements should be concealer only in conjunction with the detail information contained <unk> SEC filings.
Polluting the risk factors described.
Oh boy on form 10-K.
This time I'll turn the call for it to that.
Thanks, Alex.
Thanks, everyone for joining us this morning for first quarter results in business update call.
I hope that everyone is staying safe and healthy during these unprecedented and challenging times.
I'd like to start by saying that our priorities as a company.
Ensuring the safety and well being over catalyst team members.
Shaped gardy and uninterrupted supply or Firdapse churned adult.
Population.
That's supporting health care providers and patient community.
In addition, we had catalyst or working diligently to complete clinical studies evaluating firdapse for other rare neuromuscular diseases, including Musk antibody positive my question I grew up ish.
I'm proud of how quickly our team has adapted to the covert 19 business environment.
On March 16th we announced the suspension of all travel and face to face interactions with physicians patients or other contractors are vendors, including clinical trial sites.
All employees are required to work remotely from home as we've all expanded the use of digital communications as well as other enabling technology to conduct our daily tasks.
During this first quarter, we demonstrated solid execution across all functional areas of the company.
Our first quarter revenues were a minimally impacted by covered 19, as we recorded 29.1 million and net revenues achieving our internal revenue forecast.
Versus $12.4 million for the first quarter of 2000 underwriting.
This represents a 134% had decreased quarter to quarter.
Recognizing that the first quarter of last year was first quarter of the launch or Firdapse.
During the first quarter 2020, we generated an after tax operating profit of $10.4 million or 10 cents per share basic and fully diluted.
We also ended the quarter with almost $102 million in cash and investments and no funded debt.
The current patient base that is on reimbursed for Puredepth is fairly stable.
Remember the lens is a chronic disease and firdapse is an oral medication administered at home and delivered monthly to the patients residents.
However, we.
Switching to get there will be some headwinds in the second quarter when it comes to new patient starts for Firdapse.
Based on what we've seen to date, we expect some level of disruption associated with delayed diagnosis and new patient starts.
This is driven by data that suggest it pays should judge it took concessions officers are down by about 70%.
Additionally, as mentioned earlier, we implemented I didn't know travel policy for a field sales force on March 16, and as a result, they've been unable to have face to face interactions with physicians or their staff.
But as previously mentioned there has been minimal impact to the ongoing treatment of existing patients.
Again, we're doing a good job in communication with physician offices and patients through virtual meetings and other digital tools.
Due to the current uncertainties regarding the impact of crop at 19 pandemic, what our operations or financial results. We've decided that it is best to withdraw the 2020 net revenue guidance, we provided earlier this year.
The extended the impact of covered 19 on our business for the remainder 2020, well be driven primarily by the severity and duration of the pandemic.
Well, we've adopted many practices to mitigate the impact that the disruption at this time it is too difficult to reasonably estimate how the pandemic will ultimately affect firdapse revenues.
And we'll provide more information shortly regarding the current commercial activities for Firdapse.
Regardless of the current operating environment, we believe that our Firdapse franchise is strong and resilient as it provides a vital solution to a chronic in some cases life threatening disease and patients will continue to shake and receive treatment programs.
Earlier, we said that our safety stock or Firdapse includes manufactured in packaged product. It takes us to mid year 2021.
Also we have active pharmaceutical ingredient ingredient or a P.I. in stock and campaigns are underway for additionally, P.I. it should curious through 2023.
We have several qualified finished dosage form contract manufacturers in place and each of them has contingency plans in the event there one is required.
It is important to note that our entire supply chain is based in United States.
And our April 8th press release, we provided an update on our clinical development timelines at that point in time, we still expected to announced phase three results for MUSC Amaechi trial in first half of this year.
Since then we've seen that the pandemic is caused many clinical trial sites in the U.S. and Europe to temporarily suspend their clinical trial activities and redeploy staff members.
Our by care for covert 19 patients.
We are fortunate that the clinical portion of our trial has been completed.
With that last patient last visit occurring several weeks ago.
However, while the after years recent provision for guidance for conducting clinical trials. During the covered my team pandemic is helpful. Several of the site close out activities needs to be conducted in person by catalyst or a clinical research organizational staff at the site.
As soon as it is safe for CRH and contractors to travel and watch the sides are able to meet with studies sponsors will be on the doorsteps to wrap up this trial.
After completing or close out does it at all the trial sites will then be in a position to lock the database and begin to analyze the data and generate the topline data to report on.
Based on all of these factors, we now believe there will be in a position to announce topline data from this trial in the next quarter.
Assuming this trial is successful we expect to submit a supplement to our new drug application for Firdapse for the treatment a MUSC Mg later this year or early next year.
As previously announced duty covered 19 restrictions imposed by the Serbia and government.
Our recruited and screen SDMA type three study subjects at the site will not be able to start as originally scheduled.
Because of this this study has been delayed and based on available information. We now expect to have topline data from that study to report on later this year.
Steve will provide more information on these programs and we look forward to providing additional updates on our clinical development activities as we have more information.
We continue to make progress at our geographic expansion efforts for Firdapse in Japan, and Canada last quarter, we announced a way of submitted our NDS firdapse for limbs in Canada, which was accepted in granted a priority review.
We expect to potential approval of this NDS in the second half of this year.
We're also an early discussions with potential marketing partners in both Canada and Japan.
Expansion or product offerings, and diversifying our pipeline remains critically important part of our strategic plan.
Good day plunger, our vice President business development has been very engaged in reviewing potential transactions for partnering and for products and door companies to acquire it would represent a good strategic fit for US However, new agreements have been entered into to date.
So small degree the pandemic has also slowed the progress over a lawsuit against the FDA regarding their unauthorized approval of reserves.
Hi, hearing had been scheduled in March on a number a procedural issues, but was delayed until mid April did it becomes 19 related obstacles on the magistrates docket.
It was procedural issues have been resolved indication is proceeding to what appears to be a final briefing, which will take place.
At that point will be awaiting a final decision the timetable for that decision is still somewhat open but seems most likely to occur at some point later this year.
Our confidence in the strength of our position in this case remains unchanged, but this sort of litigation is always difficult to predict.
Lastly in April as we were pleased to announce the catalyst became a corporate partner with the first responders Children's Foundation.
Hi, Good 19 Emergency response fund this fund provides financial assistance to the families of emergency in healthcare workers.
That are on the front line during those covert 19 pandemic, we're honored to be part of this very important cost.
I'll now turn the call over to Dan bread, and our Chief commercial officer to provide you with details on our commercial operations.
Thanks, Pat and good morning, everyone.
We are happy with our continued success, helping adult lens patients with Firdapse now that we have officially moved out of our launch here with 46, new patients prescribed firdapse in the first quarter over 575 patients have now received a firdapse prescription from initial launch to the ended the first quarter.
2020.
We were excited to see a noticeable uptick in new patient enrollments in January and February compared to the last few months in 2019.
As a direct result of our updated commercial strategies.
Will force expansion and initiation of a well run inside sales lead generation and communication effort.
March new patient enrollments were ahead of forecast and that was even looking like we might have our first month of 20, plus enrollments since mid last year, but as Pat mentioned on March 16th we pulled our sales force from the field and began to see the impact of a greatly reduced number of land patient office.
As you May know less patients have two separate key risk factors, making them susceptible to severe cobot 19 disease in that they are often over 60 years old and have weakened immune systems. They have been rightfully worried about venturing out to hospitals or.
Physician offices for anything other than emergency care.
Has that already indicated our first quarter net sales of 29.1 million within our target, but I will explain how we arrived there for a few different reasons than expected.
We felt the beginning of the year headwinds normally experienced with medication in an ultra rare disease area with patients changing insurance carriers, the reset of deductibles and new co payment about new co my payment about.
And the payer reauthorization process.
In our favor was the increased number of new enrollments mentioned earlier as well as an unforeseen slight increase in forward purchasing a prescriptions that patients requested in order to ensure that they had enough medication on hand to address their anxiety about medical supply shortages in light of the Corona virus pandemic.
We were also happy to see continued strong medication compliance and persistence. The 90 day discontinuation rates have continued to improve from last quarter.
Our catalyst pathways patient services teams have done a tremendous job responding to worries in requests doing everything possible to support the patients and physicians during this period.
Early in March we communicated confidence in our manufacturing supply and inventory to the ones community and we're happy to report that Dot one patient has experienced a gap with their on hand medication, which is a well documented concern that rare disease patients have at this time.
Prescription approval rates remain around 90% across all government or private commercial insurers are co pay and financial support programs continue in full force in the Q1 average out of pocket was a dollar and nine cents per patient per month.
We have increased our use of social media as another way to update communication to the lens community.
The customer service levels and ratings remain as high as they have ever done.
This is a testament to who we are as a company always willing to go to incredible lengths to make a difference even during these challenging times for our employees to get out and about.
I'm proud of the level of collaboration cooperation and support from our commercial patient services and medical affairs teams. During these times.
Moving forward, we will continue to see increased levels of virtual interactions with phone video and email communication from our patient access liaisons with patients and by our field force with health care providers, whether that be electronic introductions educational calls or an increased utilization of new.
Really created digital educational materials that are approved for email use responding to position questions and request.
While these are challenging times, we remain confident in the ability of our team to bring firdapse to positions and adult patients. We remain confident that our catalyst pathways programs will continue to help any adult LEMS patients who needs firdapse to obtain it regardless of their insurance coverage or ability to.
Okay, we're looking forward to getting back to growth with Firdapse in adult LEMS patients and also excited about the prospect of helping additional patient populations like must positive Miocene you grab it as we work to expand firdapse indications in the coming months and years I will now turn the call.
Or to Dr., Stephen Miller, our Chief operating Officer, and Chief Scientific Officer for an update on R&D activities.
Thanks for the commercial update them and I'll provide an update on our clinical pipeline to develop firdapse for additional neuromuscular indications.
First I will turn to our phase three trial and I'm your west KMG.
Evaluate for safety Tolerability and potential efficacy of Firdapse for the symptomatic treatment of them U.S.K. Mart senior Travis.
As we reported in March we completed and exceeded our enrollment goals for this phase three trial and I'm pleased to report that we successfully completed all subject visits by mid April further clinical portion of the trial and collected all necessary clinical endpoint and safety data.
When the status with this clinical trial was reported in March we indicated the topline results would be reported during the first time for 2020.
This was based on statements by public health authorities and government officials at that point in time regarding when the covert 19 related restrictions and mitigation strategies.
And our assessment of what impact the timing of those covered my team restrictions wearable and the trial.
By the time of our April.
Good night team update press release, only a few subjects maybe to complete their lives visits for the sites in Italy, Serbia and the U.S. about this point in time, Serbia also announced restrictions on the conduct clinical trials, but fortunately did not materially affect the completion of the last ambulance KMG patient there.
Correct, Yes, somebody proof of concept for which I'll discuss in a moment.
Since that time it has become clear the covert like dream restrictions and mitigation strategies will be used later than we previously anticipated.
And that the easing of restrictions as was recently described by the White House will be a more gradual three phase process.
Prolong restrictions are delaying the completion of required regulatory.
Clinical trial closeout activities prior to Unblinding reporting of topline results and now we anticipate reporting topline results in Q3 of this year.
We're conducting frequent meetings of our database lock team to find and implement alternative strategies for continued monitoring and remote drug accountability and where needed those strategies are being presented to local regulatory authorities for implementation. However, catalyst will never do anything we would compromise safety as well for patients. This is also led to fund.
Turning to have ways of getting studied medications to patients while most research sites are closed.
As we previously mentioned we remain cautiously optimistic about the outcome of this phase three trial Assembly was KMG as a relatively homogeneous disease and we are hopeful the response to treatment will be similar to a previous proof of concept trial.
Assuming positive results of this phase three trial, we hope to file a supplemental and be a firdapse for our newest KMG later by the end of this year or in the first quarter or 20 to 21.
Gross KMG is an auto immune disease for which there is currently no approved treatment and we believe there are about 3000 to 4800.
Yes patients with emulex, KMG and the United States, assuming the trial is successful we look forward to one day potentially being able to provide an FDIC approved treatment option for these patients.
Second trial that I would like to provide an update on these are proof of concept study. Some a type three which is at all which is ongoing in Italy in Serbia.
Valuating the safety tolerability of potential efficacy of them for operating for the symptomatic treatment of estimate three and ambulatory patients on April if we announced that we would not be reporting topline results for this trial in Q2 due to clinical delays caused by the Serbian governments response to covert my team I hope emergency.
But we were able to provide we were unable to provide guidance on future reporting due to be unknowns at that time regarding the easing of cobot 19 related restrictions. We now believe for top line results will be available before the end of year.
Estimate is caused by related genetic defects some improved team and motor neurons. This initial proof of concept study is a crossover design with a two week treatment time in each period.
Designed to measure changes in SMB disease symptoms, but does not address disease progression.
SMB type three.
Estimated prevalence of between 3500 4200 patients. It is important to note that all four tights types of estimate or caused by various Truman defects.
Same gene codes for the us protein, resulting in variations and severity, which are broadly characterized as it may types. One through four differs proof of concept CRO successful catalyst and times to discuss the design of a multi center phase three clinical trial with the after which we intend to address both symptomatic treatment.
And disease progression and perhaps more than one type of somebody.
Moving onto market expansion plans for Firdapse.
The review of catalyst pending new drug submission in Canada for the treatment of labs is ongoing catalyst was granted priority review for this drug RMBS, which will be which will reduce the review cycle time six months.
Most expects approval of assembly.
For 2020 and has not yet started commercialization activities in Canada.
Carlos is also continuing our market expansion activities in the territory of Japan.
We expect it to meet with the Japanese pharmaceuticals, and medical device agencies or PMT regarding the regulatory pathway to seek approval for ducks in Japan, and the second quarter, but due to the ongoing covert 19 restrictions in Japan. This meeting has been delayed until the second half twentytwenty.
Approximately three years ago, the Japanese government designated the approval of MBR for Aberdeen actually priority drug for the Ministry of Health Labor and welfare and they have been actively soliciting companies to develop and file and then be a for this drove.
An update on the regulatory pathway for filing an idea in Japan will be provided wants catalyst on the PMTA come to an agreement on what will be required to file that EMEA in Japan.
Patients have requested a long acting version for Firdapse in order to eliminate the need to plan their daily activities around multiple doses Firdapse. We're now actively developing this new product will provide updates in the future when the product characteristics have been finalized at this stage of the development program can be formulations are being developed.
Other drug release properties are being started in order to optimize for long acting symptomatic treatment of loans.
Due to the types of activities that.
We are ongoing in the first half of 2020 to covert.
Corporate making health emergency has had no effect to the date.
On the progress of this program.
Finally catalyst will also begin proof of concept studies in the near future for additional neuromuscular conditions to be evaluated such as Kennedy's disease.
Hereditary.
Neuropathy with liability to pressure policies as the details of these trials are finalized catalyst will provide more details about the trial design disease and prevalence.
I have some final comments on the ongoing public health emergency related to the cobot nights few virus. Despite the challenging current environment due to covert 19 and be impacts that this global health crisis is having on our timelines we remain extremely committed to these trials evaluating firdapse and other neuromuscular indications. Additionally, as Pat mentioned.
But our current support Firdapse for patients with Worms. We're also confident in the supply of product needed for ongoing clinical trials.
New these trials as efficiently as possible 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 path as we become available I will now.
On the call over to Alexander or Chief Financial Officer to review our financial results.
Thanks, Steve.
Yesterday, we filed our first quarter form 10-Q, and reported GAAP net income of 10 point Fivemillion 10 cents per basic and diluted share compared to a GAAP net loss of 645001 cents per basic and little issue in the same period 2019.
For the first quarter 2020, non-GAAP net income excluding 1.5 million of expenses related to non cash that weeks compensation was 11.9 million 12 cents per basic and 11 cents per then this year.
In comparison first quarter 2019, non-GAAP net income excluding 933000 of expenses related to non cash stock based compensation was 289004 cents per basic and diluted share.
Net revenue for freight which was launched during January 2000, 1929 point.
1 million for the first quarter 2020.
Related cost of sales bullet point 2 million.
For the first quarter 2018, net product revenue for yet from trade ups.
12.4 million with related cost of sales in the quoted 1.7 million.
It's important to remember that our gross margins continued to benefit from the inventory manufacture and expense.
Prior to the FDA approval fairness.
Research and development expenses would flip point 2 million for the first quarter 2020, as compared to 3.3 million visitors call. It 20000 night.
Research and development expenses for the first quarter 2020, and the first would have 20 team.
Hi, Andy consisted of expenses, the medical and regulatory affairs.
I'd issuance Berlin's expenses, some ongoing freight ups clinical trials and studies and caused.
On the exit.
We expect that research and development costs will continue to be substantially 2020, as we complete ongoing clinical trials one study.
You SK Mg estimate to type three continue expanded access program and our sustained release limitation for the answer for that.
The answer to evaluate trade ups as a treatment for others.
The thesis.
Assuming positive results from the trial.
Bps supplemental NV for freight ups for the treatment of IMMU SK Mg.
As you and expenses specifically of 2020 totaled 10.1 million compared to 8.1 million in the first quarter 219.
The increase when compared to the same period in 2019 is primarily attributable to increases in headcount due to the expansion of the sales. Please.
Contracting with earlier these ses experience in say sales agency and an increase in noncash stock compensation expense.
We expect that as Danny will continue to increasing to 20 as we continue to bill.
Preset CIT and commercial and patient.
In support of our sales activities, we refer to.
We continue to pursue our lawsuit against the FDA.
In March 31st 2020 steadily has had cash and investments of 101.8 million no funded.
More detailed information on analysis, maybe found in the Companys quarterly report on form 10-Q, which was filed with the Securities and Exchange Commission yesterday May 11.
And can be found on the Investor Relations page of our website at www dot steadily spine.
Now I'll turn the call we did that.
Thank you Alley.
Again, I'm very proud of the entire catalyst team and the way in which our organization has come together during this global pandemic.
We're committed to bringing lifesaving treatments to patients in need and then these challenging times, you'll continue to fully support our patients healthcare providers and the broader community.
We started off 2020.
A strong execution and expect to continue down momentum through the balance of this year.
Despite the difficult times that we face today.
I have never been more optimistic about the prospects for our company in the second half of this year and beyond.
Thank you again every two everyone who joined US this morning, and with that we'll open the lines for questions operator.
Thank you the floor is now open for questions. If you would like to ask a question. Please press star one on your telephone keypad at this time a confirmation total indicate your line is in the question Q.
You May press Star too if you would like to remove your question from the Q for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.
Once again, that's star one to register questions at this time.
My first question is coming from Joe kept Bizzaro Piper Sandler. Please go ahead.
Hi, guys. Thanks, so much for taking my questions here.
Maybe first a couple on on on the commercial launch here I'm wondering if maybe you'd be able to provide some metrics that you previously provided namely how many patients who are actively receiving insurance reimburse firdapse at the end of one Q and Dan you noted that 90 day discontinuation rates continue to improve just wondering at this point of view.
Have a good sense of how many new patient starts you need per quarter to outpace the rate of existing patients coming off therapy. Thanks.
Sure. So the first question.
Again was on the.
Can you repeat the first part I got the second part on the 90 day discontinuation.
Yes. So the first part is with regards to a metric I think you got the previously provided there on how many patients were actively receiving insurance reimbursed.
Firdapse at the end of.
Q.
Yes, I mean, we're trying to now that we're through the launch here and we were able to give you a lot of metrics to get into detail. We're trying to just.
Rely on the sales levels.
To give you from here on out a clear understanding of our performance.
We did have somewhere in the neighborhood of 335 to 340 patients that were reimbursed, but some of these metrics again, we gave them last year. So you had an idea of where things are going but they are variable and that gets complex like for example in the first quarter.
That number jumps around because a lot of patients are changing insurance.
Our getting reauthorizations done and such.
So thats why weve stuck with the with the revenue level as far as the 90 day discontinuation rate Yeah. We're very happy with that I think I mentioned last year in middle of the year. It was around 35% by the end of year. It got down to 25%. We're actually now looking like it's lower than 20% and we hope that holds.
Did a lot of the programs that we have in place and so that is an important metric for us and in order to get the growth that we we are hoping and ultimately with the the previous guidance, we need to be in the neighborhood of 15 to 20 patients new patient enrollments per per month in order to to get that type of.
Growth.
Okay got it that that's very helpful and I'd just ask one one follow up then I think you also mentioned that.
There was maybe an uptick in long term longer term prescriptions.
Towards the ended the quarter just wondering if you could elaborate a little bit on that and how that could potentially impact to Q revenues. Thanks.
We were first very interested in making sure that we were.
Making sure that patients had coverage in the third anxieties.
There.
We're pleased with regards to being able to get continued supply and so we did see in the middle and end of March a little bit of additional prescribing. So so perhaps a few advance scripts coming in that normally would have waited until April coming in at the end of the month.
And some small percentage of patients that went up to 60 or 90 days, but overall it didnt have a very large impact and we think it's because we've provided such good service to them and they have good confidence with us we communicated in at bats, and so the impact really is somewhere in the one to one and a half million dollars range.
Which will ultimately resolve throughout the rest of the year.
Okay got it that that's very helpful. Thanks, so much for taking my questions.
Sure.
Thanks, Jeff.
Thank you. Our next question is coming from Charles Duncan of Cantor Fitzgerald. Please go ahead.
Monotaro morning, Pat Yeah, Good morning patent team.
Thanks for all the information and appreciate the challenges that you have to as.
As a lot of folks in terms of managing this current pandemic.
I wanted to ask your question and then a couple for Dan and maybe one for Steve with regard to you as as you think about whether or not to withdraw versus widened guidance I'm wondering if if withdrawing isn't an abundance of.
Caution or are you seeing anything new just kind of.
Let us know your philosophy on.
And why now you would withdraw versus white guidance.
Yeah, we gave a lot of thought to that.
Charles and we have we talked a great deal about it at the board level as well as what the audit Committee and we just felt if we were not comfortable with in this environment and leaving that guidance out at 135 to 155.
Which was already a fairly wide range.
We didn't think it'd be appropriate so lower the guidance or to widen it and then perhaps have to come back in a month or two or three and do it again, so until we have a better handle on what things look like for us and for the health care community at large.
Yeah, we felt as the prudent thing to do it it's nothing more than that it's there is no trend. In fact, you know were extremely optimistic about.
The qualitative direction of the company and what we're seeing out there.
The commercial side so.
I hope that answers your question.
Yes, it does and I I appreciate the challenge and and I I appreciate the conservativism hopefully it proves to be the case, maybe if I could ask Dan a couple of questions related to that which is he mentioned increase you still have virtualized platforms.
Im reaching out with two potential prescribers and I am wondering Dan if you could provide any additional.
I guess information on what those platforms may be not specific names, but but really this strategy behind them.
Well I mean did it mainly gets to staying in contact with physicians and continuing to remind them that patience with rare disease has significant issues and so we're doing that and quickly move to approve a lot of our materials that we had in hand to to be able to be emailed.
That we have increased our digital presence.
In reminders to physicians online with banners in such that drives them to our web sites and asked them to request for a phone consultation in such a we're having virtual lunches and so we have all of those.
In place and we still are seeing new patient starts, but do but it is very evident that patients and physicians just aren't seeing each other and to some extent with tele medicine that helps but but we can really tell that physicians and patients just started seeing each other during this time.
Makes sense and we've asked the question of many of our neurology and psychiatry focus.
Revenue generators, and I guess I'm wondering if you could characterize the at least qualitatively you discussions.
With that prescribers in April versus May and what would you anticipate and in June using those virtualized formats.
Well, it's it's it really does depend upon the physician and a system that they are in the in the hospital to some extent to me. It's all over the board you have physicians.
Perhaps an academic centers that are over run with covidien. They completely shifted resources that don't want to talk to anyone and you have others that are like yet I have some time to talk and I. Appreciate your willingness to provides us a virtual lunch and have a discussion with me about your programs that you still have in place and their curious and.
So it does carry the gamut some some positions enjoy being able to communicate back and forth with email and will reach out to us and talk to US sales representative if and when they have a patient that actually has a calder come in to to get a diagnosis and we've seen some of those.
Just even in the last week, we can have where patients are actually still getting diagnosed and whether that be.
Continuing to get antibody test.
Or medium testing, we're pleased to see that thats still happening, but Charles it's really all it's all over the board.
Okay. Appreciate that one last question for Steve and that is really related to the ongoing MUSC and she study.
Oh.
Steve if you could remind us or update us on youre kind of view on the condo could that study appreciate that it's almost.
Ramped up but as you look at you know measures of quality or heterogeneity.
Dispersion within the Emerald sample, how do you feel about that and what what drives you're cautious optimism on now outcome of that study.
Well <unk> effects Charles.
As I mentioned.
In my.
Opening remarks the.
Patient population is relatively homogeneous for U.S.K. and by that I meant that.
<unk>.
I mean was carry my senior gravis patients diseases caused by a single antibody to a single protein in the neuromuscular junctions and so what happens is that neuromuscular junction and that protein in that junction has a very specific function and so the expectation when you have a disease that is so specific.
Is that there should be quite a bit of Homer Jim generically and the type of damage that's done to the neuromuscular junctions wells to clinical presentation of the patient they all have similar symptoms and similar.
Infirmities related to the disease no more importantly that homogeneity and the fact that single protein, which affected also results in homogeneity to response, we actually saw that and the Lamberty mice.
LEMS mice.
Disease, where the patients had an antibody to voltage good calcium channels and in that case all of the patients had a very similar clinical presentation of our similar response to treatment not only in our two trials, but in other trials were published literature as well. So there's a lot of similarity in terms of how would you maybe the patient.
Dilution and so because of the fact that we had a very robust resolved in or proof of concept trial for the treatment of ambulatory My senior gravest.
Coupled with the fact that be disease cause of disease as well as the clinical presentation appears to be very homogeneous we believe.
But we should see similar trying to findings for this ongoing trial and we remain cautiously optimistic about the.
Current Roe.
Very good thanks for all the added color and look forward to.
Gaining additional traction over the course the year. Thank you. Thanks, Charles the question Charles.
Good.
Oh excuse me. Thank you. Our next question is coming from Leland Castle of Oppenheimer. Please go ahead.
Hey, good morning time, Thank you for taking my questions congratulations on.
Hi, and navigating this.
This whole situation that we're all faced with.
So successfully wanting to ask your perspective on business development activities, you know how those may have been impacted.
By covert 19 itself, perhaps by maybe some more uncertainty around.
Current your financials.
With regard to the deferred up business.
Perhaps you can comment on on your efforts there and.
And any focused that you may be directing your efforts towards in terms of.
Particular projects or assets that may be of interest in the near future. Thanks.
Thanks for the question later on.
We have stated earlier that we are really not looking for early stage opportunities and terms or product opportunities looking for later later stage beyond proof of concept ideally we'd like to find project. So we could bolt on where their sales reps many neuromuscular.
Or at least neurology.
Nature, and so our criteria is fairly tight right now.
We are seeing a fair amount of opportunities.
And I think that's because of Dave's extensive rolodex.
That that we're now seeing all of these opportunities I think also the pandemic has probably.
Caused us to see more opportunities. So we normally would because companies are concerned about their next round of financing.
And.
The capital markets are open I think the valuations are ground down pretty good.
And so.
I think it's a very.
Jerry fertile environment for us.
Two to.
To find the right opportunity of the product acquisition.
And or a company at this time.
Thank you that that's helpful. I also just a quick question on on the production itself.
Now do you have been market for some time was wondering if you could define from your experience may be hard to see from the numbers that we see but any particular seasonality that you determine from.
Firdapse has its launched into lemons.
And then any seasonality that may affect the limbs population or the the overall neuromuscular patient population. Thank you.
Dan you want to take that question.
Yeah, I mean, we haven't to date.
In any of that seasonality, mainly because you know last year in the summer months, we are really in the launch growth phase and but we would expect that this summer months would have an increased level.
Level of prescriptions, just because he actually does affect the neuromuscular junctions negatively and so you actually have an increased symptomatology with with the summer months. So we're we're encouraged that concept and we'll be ready it looking for that but we didnt, we haven't seen at thus far.
Okay. That's great. Thanks, very much for the information.
Great. Thank you Leyland pipe.
Thank you. Our next question is coming from Scott Henry of Roth Capital. Please go ahead.
Thank you and good morning, just a couple of questions around the launch or just trying to get my arms around it.
You know for clarity it sounds like you know if the churn rate is called 15%.
Not.
All right are you seeing really any new patients now at this point given covert 19, I guess, what I'm getting at is we it sounds like we should expect a at least some decline in twoq versus first quarter I, just want to make sure I'm interpreting that correctly.
Scott, Let me address it and then I'll turn it over to Dan.
You know, our our our reimburse number of reimbursed patients on Firdapse.
It was fairly stable and we expect that and those that are that are on drug for a longer than 90 gauge I'm, including in that in that category are really stable, we view that as a pretty good base now people do drop out they can't so they just continue the unfortunate.
Only some pass away, but that's a fairly stable number and albeit you know we've expanded double our field force and as Dan mentioned Weve employed a lot of new.
Technology to to reach patients and to reach physicians and despite the fact that in in April.
We saw a downtick as it comes as compared to January February and March where we were starting to get on a role before the pandemic.
Having said that we were happy.
With the reduction, but we are enrolling new patients and I don't want to get into 10 numbers again, I think that over the past year. The launch year. We we've provided a lot of different launch metrics.
To investors into analyst and we felt it was important to do so we think now the most important thing and will rest on our revenues as we as we move forward and I think that it's important to understand as we talked about earlier the qualitative direction of what is actually happening.
In the patient and physician community.
With Firdapse. So again, we at all like to be sitting here with better numbers. In Q2, then maybe we're seeing for the moment, but it it's not falling off a cliff and we are enrolling new patients.
So Dan we may have something you want to add to that I'm not sure. If I had one smart analysts got the had some additional color you're looking for.
No I think that that was helpful right there.
But I guess in a related question from a pricing standpoint, or we now at it at a time, where the revenue per patient is he is relatively stable as well and in over time, you would you expect that to creep up for for one reason another or how should we think about that revenue per patient trend.
Oh, I don't see any significant changes to the revenue per patient trends.
Okay, and Oh, I guess further any color.
On a at least qualitatively, what you're thinking about how how the jacobus launches proceeding and I are you noticing any impact from that relative to the last quarter. It doesn't remain relatively modest.
It it remains relatively modest I mean, we did see again with the change of insurance and Reauthorizations, a small uptick again at the very beginning of the year.
That has again subsided. So I think it it's still becomes a minor impact and really what what matters for us in that we've seen a was working and especially working with the with the expansion of our Salesforce and employing this inside sales.
Is communicating to many position to quite honestly, our just seeing their first or second lens patient and are happy to hear that there is a medication available and their quickly getting onto to Firdapse. I mean, that's for us getting back onto that pre co that trend of new patient enrollments is the name of the game.
Okay, Great a in a final question just for clarification I think he said there were 46 new patient.
In the quarter are are you distinguishing between those naive to therapy or perhaps switches who had used at pryor.
Yes, part for the most part yeah all of those perhaps other than one or two our naive previously never on three four DAP and so these these are truly patients that have either already been diagnosed and and just hadn't had access.
To this this type of great medicine.
Sure they were people that were newly diagnosed.
Okay, great. Thank you for taking the questions.
Thank you Scott.
Thank you at this time I'd like to turn the floor back over to pad for closing comments.
Thank you for joining us today, we look forward to further updates pleased to be safe and have a great day.
Ladies and gentlemen, thank you for your participation. This concludes today's event you may disconnect. Your lines at this time and have a wonderful day.
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