Earnings Call Transcript - CPRX Q1 2020

Operator, Operator

Greetings and welcome to the Catalyst Pharmaceuticals First Quarter 2020 Results Conference. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. It’s now my pleasure to introduce your host, Ms. Ali Grande, CFO. Thank you. You may begin.

Alicia Grande, CFO

Good morning, everyone, and welcome to today's conference call. Joining me on today's call are members of the Catalyst team, including Patrick McEnany, Chairman and Chief Executive Officer; Dr. Steven Miller, Chief Operating Officer and Chief Scientific Officer; Dr. Gary Ingenito, Chief Medical Officer and Head of Regulatory Affairs; and Dan Brennan, our Chief Commercial Officer.

Patrick McEnany, CEO

Thank you, Ali, and thanks everyone for joining us this morning for our first quarter results and 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 are ensuring the safety and well-being of our Catalyst team members, safeguarding an uninterrupted supply of Firdapse to an adult LEMS population, and supporting healthcare providers and patient communities. In addition, we have catalysts who are working diligently to complete clinical studies, evaluating Firdapse for other rare neuromuscular diseases, including MuSK antibody-positive Myasthenia Gravis. I'm proud of how quickly our team has adapted to the COVID-19 business environment. On March 16, we announced the suspension of all travel and face-to-face interactions with physicians, patients, or other contractors or 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 minimally impacted by COVID-19 as we recorded 29.1 million in net revenues, achieving our internal revenue forecast versus $12.4 million for the first quarter of 2019. This represents a 134% increase quarter-to-quarter, recognizing that the first quarter of last year was the first quarter of the launch of Firdapse. During the first quarter of 2020, we generated an after-tax operating profit of $10.4 million or $0.10 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 days on reimburse Firdapse are fairly stable. Remember, LEMS is a chronic disease, and Firdapse is an oral medication administered at home and delivered monthly to the patient’s residence.

Dan Brennan, CFO

Thanks, Pat, and good morning, everyone. We are happy with our continued success helping adult LEMS patients with Firdapse now that we have officially moved out of our launch year. With 46 new patients prescribed Firdapse in the first quarter, over 575 patients have now received a Firdapse prescription from initial launch to the end of the first quarter of 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, field force expansion, and the initiation of a well-run inside sales lead generation and communication effort. March new patient enrollments were ahead of forecast and it was even looking like we might have our first month of over 20 enrollments since mid-last year, but as Pat mentioned, on March 16, we pulled our salesforce from the field and began to see the impact of a greatly reduced number of LEMS patient office visits. As you may know, LEMS patients have two separate key risk factors, making them susceptible to severe COVID-19 disease, as they are often over 60 years old and have weakened immune systems. They have rightfully been worried about venturing out to hospitals or physician offices for anything other than emergency care. As Pat already indicated, our first quarter net sales of 29.1 million were at 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 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 of 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 coronavirus pandemic.

Steven Miller, COO and CSO

Thanks for the commercial update, Dan. Now I'll provide an update on our clinical pipeline to develop Firdapse for additional neuromuscular indications. First, I will turn to our Phase 3 trial and MuSK MG to evaluate the safety, tolerability, and potential efficacy of Firdapse for the symptomatic treatment of MuSK Myasthenia Gravis. As we reported in March, we completed and exceeded our enrollment goals for this Phase 3 trial, and I'm pleased to report that we successfully completed all subject visits by mid-April for the clinical portion of the trial and collected all necessary clinical endpoint and safety data. When the status of this clinical trial was reported in March, we indicated that the top-line results would be reported in the first half of 2020. This was based on statements by public health authorities and government officials at that point in time regarding when the COVID-19-related restrictions and mitigation strategies would be eased, and our assessment of what impact the timing of those COVID-19 restrictions would have on the trial. By the time of our April 8 COVID-19 update press release, only a few subjects needed to complete their last visits for the sites in Italy, Serbia, and the U.S.; about this point in time Serbia also announced restrictions on the conduct of clinical trials that fortunately did not materially affect the completion of the last MuSK MG patient there, but did affect the SMA proof of concept trial, which I'll discuss in a moment. Since that time, it has become clear that COVID-19 restrictions and mitigation strategies will be eased later than we previously anticipated, and that the easing of restrictions, as recently described by the White House, will be a more gradual three-phase process. These prolonged restrictions are delaying the completion of required regulatory and clinical trial closeout activities prior to un-blinding and reporting of top-line results. Now, we anticipate reporting top-line results in Q3 of this year. We are conducting frequent meetings of our database log team to find and implement alternate strategies for continued monitoring and remote drug accountability, and where needed those strategies are being presented to local regulatory authorities for implementation. However, we will never do anything that would compromise the safety and welfare of our patients. This has also led to finding alternative ways of getting study medications to patients while our most research sites are closed. As we previously mentioned, we remain cautiously optimistic about the outcome of this Phase 3 trial as MuSK MG is a relatively homogeneous disease, and we are hopeful the response to treatment will be similar to our previous proof of concept trial. Assuming positive results of this Phase 3 trial, we hope to file a supplemental NDA for Firdapse for MuSK MG later by the end of this year or in the first quarter of 2021. MuSK MG is an autoimmune disease for which there is currently no approved treatment and we believe there are about 3,000 to 4,800 patients with MuSK MG in the United States. Assuming the trial is successful, we look forward to one day potentially being able to provide an FDA-approved treatment option for these patients. The second trial that I would like to provide an update on is our proof of concept study in SMA Type 3, which is ongoing in Italy and Serbia, and is evaluating the safety, tolerability, and potential efficacy of amifampridine for the symptomatic treatment of SMA Type 3 in ambulatory patients. On April 8, we announced that we would not be reporting top-line results for this trial in Q2 due to clinical delays caused by the Serbian government's response to the COVID-19 health emergency, but we were unable to provide guidance on future reporting due to the unknowns at that time regarding the easing of COVID-19-related restrictions. We now believe the top-line results will be available before the end of the year. SMA is caused by related genetic defects to the SMN protein in motor neurons. This initial proof of concept study is a crossover design with a two-week treatment time in each period and is designed to measure changes in SMA disease symptoms, but does not address disease progression. SMA Type 3 has an estimated prevalence of between 3,500 and 4,200 patients. It is important to note that all four types of SMA are caused by various genetic defects to the same gene that codes for the SMN protein, resulting in variations in severity, which are broadly characterized as SMA Types 1 through 4. If this proof of concept trial is successful, Catalyst intends to discuss the design of a multicenter Phase 3 clinical trial with the FDA in which we intend to address both symptomatic treatment and disease progression and perhaps more than one type of SMA. Moving on to market expansion plans for Firdapse, the review of Catalyst's pending new drug submission in Canada for the treatment of LEMS is ongoing. Catalyst was granted priority review for this drug NDS, which will reduce the review cycle time to six months. Catalyst expects approval of this NDS in the second half of 2020 and has not yet started commercialization activities in Canada. Catalyst is also continuing our market expansion activities in the territory of Japan. We expected to meet with the Japanese Pharmaceuticals and Medical Device Agencies or PMDA regarding the regulatory pathway to seek approval of Firdapse in Japan in the second quarter, but due to the ongoing COVID-19 restrictions in Japan, this meeting has been delayed until the second half of 2020. Approximately three years ago, the Japanese government designated the approval of amifampridine as a priority drug for the Ministry of Health Labor and Welfare, and they have been actively soliciting companies to develop and file an NDA for this drug. An update on the regulatory pathway for filing an NDA in Japan will be provided once Catalyst and the PMDA come to an agreement on what will be required to file that NDA in Japan. Patients have requested a long-active version of Firdapse in order to eliminate the need to plan their daily activities around multiple doses of Firdapse. We are 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, candidate formulations are being developed and their drug release properties are being studied in order to optimize for long-acting symptomatic treatment of LEMS. Due to the activities ongoing in the first half of 2020, the COVID-19 health emergency has had no effect 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 and hereditary neuropathy with liability to pressure palsies. 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 COVID-19 virus. Despite the challenging current environment due to COVID-19 and the impact this global health crisis is having on our timelines, we remain extremely committed to these trials and evaluating Firdapse in other neuromuscular indications. Additionally, as Pat has mentioned about our current supply of Firdapse for patients with LEMS, we are also confident in the supply of product needed for ongoing clinical trials so that we can continue 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 in additional countries, and to develop a better product for all these patients. We will provide any updates on these clinical and regulatory paths as they become available. I will now turn the call over to Alicia Grande, our Chief Financial Officer to review our financial results.

Alicia Grande, CFO

Thanks, Steve. Yesterday we filed our first quarter Form 10-Q and reported GAAP net income of 10.4 million or $0.10 per basic and diluted share, compared to a GAAP net loss of 645,000, or $0.01 per basic and diluted share in the same period of 2019. For the first quarter of 2020, non-GAAP net income, excluding 1.5 million of expenses related to non-cash stock-based compensation was 11.9 million or $0.12 per basic and $0.11 per diluted share. In comparison, first quarter 2019 non-GAAP net income excluding 933,000 of expenses related to non-cash stock-based compensation was 289,000 or $0.00 for basic and diluted share. Net product revenue for Firdapse, which was launched in January 2019, was 29.1 million for the first quarter of 2020 with the related cost of sales of 4.2 million. For the first quarter of 2019, net product revenue for Firdapse was 12.4 million with a related cost of sales in the quarter of 1.7 million. It's important to remember that our gross margins continue to benefit from the inventory manufactured and expensed prior to the FDA approval of Firdapse. Research and development expenses were 4.2 million for the first quarter of 2020, compared to 3.3 million for the first quarter of 2019. Research and development expenses for the first quarter of 2020 and the first quarter of 2019 primarily consisted of expenses for medical and regulatory affairs, quality assurance programs, expenses from our ongoing Firdapse clinical trials and studies, and cost for our Expanded Access Program. We expect that research and development costs will continue to be substantial in 2020 as we complete our ongoing clinical trials and studies in MuSK MG and SMA Type 3, continue our Expanded Access Program, and sustain our release formulation program for Firdapse. We began to evaluate Firdapse as a treatment for other neuromuscular diseases, and assuming positive results from the trial, we will file a supplemental NDA for Firdapse for the treatment of MuSK MG. SG&A expenses for the first quarter of 2020 totaled 10.1 million, compared to 8.4 million in the first quarter of 2019. The increase when compared to the same period in 2019 is primarily attributable to increases in headcount due to the expansion of the sales force or contracting with a rare disease experienced inside sales agency, and an increase in non-cash compensation expense. We expect that SG&A will continue to increase in 2020 as we continue to build our infrastructure and commercial and patient programs in support of our sales activities for Firdapse and continue to pursue our lawsuit against the FDA. On March 31, 2020, Catalyst had cash in investments of 101.8 million and no funded debt. More detailed information and analysis may be found in the company's 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.

Patrick McEnany, CEO

Thank you, Ali. 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 are committed to bringing life-saving treatments to patients in need and in these challenging times we will continue to fully support our patients, healthcare providers, and the broader community. We started 2020 with strong execution and expect to continue that 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 to everyone who joined us this morning. And with that, we'll open the lines for questions.

Operator, Operator

Thank you. Our first question is coming from Joe Catanzaro of Piper Sandler. Please go ahead.

Joe Catanzaro, Analyst

Hi, guys, thanks so much for taking my questions here. Maybe first a couple on the commercial launch year. 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 reimbursement for Firdapse at the end of 1Q? And, Dan, you noted that 90-day discontinuation rates continue to improve, just wondering at this point, if you 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.

Dan Brennan, CFO

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?

Joe Catanzaro, Analyst

Yeah. So the first part is with regards to a metric I think you guys have previously provided around how many patients were actively receiving insurance reimbursed Firdapse at the end of 1Q?

Dan Brennan, CFO

Yeah, I mean, we're trying to – now that we're through the launch year, and we were able to give you a lot of metrics to get into detail, we're trying to just, you know, rely on the sales levels to give you – from here on out, you know, a clear understanding of our performance. We did have somewhere in the neighborhood of 335 patients 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 were going, but they're variable and it gets complex. Like, for example, in the first quarter, that number jumps around because a lot of patients are changing insurance. They're getting reauthorizations done and such. So, that's why we’ve stuck 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 the middle of the year, it was around 35%. By the end of the 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. In order to get the growth that we are hoping and ultimately with the previous guidance, we need to be in the neighborhood of 15 patients to 20 patients, new patient enrollments per month in order to get that type of growth.

Joe Catanzaro, Analyst

Okay, got it. That's very helpful. If I could just ask one follow-up, Dan, I think you also mentioned that there was maybe an uptick in longer-term prescriptions towards the end of the quarter, just wondering if you could elaborate a little bit on that and how that could potentially impact 2Q revenues? Thanks.

Dan Brennan, CFO

Right. We were first very interested in making sure that we were making sure that the patients had coverage and that their anxieties were at ease 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, perhaps a few advanced 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 days or 90 days, but overall, it didn't have a very large impact. And we think it's because we've provided such good service to them, and they have good confidence in us. We communicated in advance. And so the impact really is somewhere in the one-to-one and a $0.5 million range, which will ultimately resolve throughout the rest of the year.

Charles Duncan, Analyst

Yeah. Good morning Pat and team. Thanks for all the information and appreciate the challenges that you face managing this current pandemic. I wanted to ask you a question, then a couple for Dan and maybe one for Steve, with regard to you, as you think about whether or not to withdraw or widen guidance, I'm wondering if withdrawing is in abundance of caution or are you seeing anything new? Just kind of let us know your philosophy on why now you would withdraw versus widen guidance?

Patrick McEnany, CEO

Yeah. We gave a lot of thought to that, Charles, and we talked a great deal about it. At the board level as well as with the audit committee, and we just felt if we were not comfortable with in this environment and leaving that guidance out, which was already a fairly wide range. We didn't think it'd be appropriate to 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 healthcare community at large, we felt it was the prudent thing to do. It's nothing more than that. There is no trend. In fact, you know, we're extremely optimistic about the qualitative direction of the company, and what we're seeing out there on the commercial side. So, I hope that answers your question.

Charles Duncan, Analyst

Yeah, it does. And I appreciate the challenge, and I appreciate the conservatism. Hopefully, it proves to be the case. Maybe if I could ask Dan a couple of questions related to that, which is he mentioned increased use of virtualized platforms in reaching out to potential prescribers. And I'm wondering, Dan, if you could provide any additional, I guess, information, what those platforms may be – not specific names, but really the strategy behind them?

Dan Brennan, CFO

Well, I think it mainly gets to staying in contact with physicians and continuing to remind them that patients with rare diseases have significant issues. And so we're doing that and quickly moved to approve a lot of our materials that we had in hand to be able to be emailed that we have increased our digital presence and reminders to physicians online with banners and such, that drive them to our websites and ask them to request for a phone consultation and such. We're having virtual launches. And so we have all of those in place and we still are seeing new patient starts, but it is very evident that patients and physicians just aren't seeing each other, and to some extent with telemedicine that helps, but we can really tell that physicians and patients just aren't seeing each other during this time.

Charles Duncan, Analyst

Make sense. And we've asked the question of many of our neurology and psychiatry focused revenue generators, but I guess I'm wondering if you could characterize at least qualitatively your discussions with prescribers in April versus May and what would you anticipate in June using those virtualized formats?

Dan Brennan, CFO

Well, it really does depend upon the physician and the system that they're in, in the hospital to some extent and it's all over the board. Yes, physicians, perhaps in academic centers that are overrun with COVID, and they've completely shifted resources don't want to talk to anyone. And you have others that are like yeah, I have some time to talk and I appreciate your willingness to provide this, you know, a virtual launch and have a discussion with me about your programs that you still have in place and they're curious and so it does carry the gamut. Some physicians enjoy being able to communicate back and forth with email and will reach out to us and talk to a sales representative if and when they have a patient that actually has called or come in to get a diagnosis, and we've seen some of those, just even in the last week, week and a half where patients are actually still getting diagnosed and whether that be to continue to get antibody tests or. We're pleased to see that that's still happening. But Charles, it's really all over the board.

Charles Duncan, Analyst

Okay, appreciate that. One last question for Steve, and that is related to the ongoing MuSK MG study. Steve, if you could remind us or update us on your view on the conduct of this study, appreciate that, it's almost wrapped up, but as you look at measures of quality or heterogeneity, dispersion within the enrolled sample, how do you feel about that and what drives your cautious optimism on the outcome of that study?

Steven Miller, COO and CSO

Thanks Charles. As I mentioned in my opening remarks, the patient population is relatively homogeneous for MuSK. By that I mean that all the MuSK Myasthenia Gravis patients’ disease is caused by a single antibody to a single protein in the neuromuscular junction. 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 a significant amount of homogeneity in the type of damage that's done to the neuromuscular junction, as well as the clinical presentation of the patient. They all have similar symptoms and similar remedies related to the disease. More importantly, that homogeneity and the fact that it's a single protein that's affected also results in homogeneity to response. We actually saw that in the Lambert-Eaton myasthenic – LEMS myasthenic disease, where the patients had an antibody to voltage-gated calcium channels, and in that case, all of the patients had a very similar clinical presentation, a very similar response to treatment, not only in our two trials but in other trials that were published in the literature as well. So, there's a lot of similarity in terms of the homogeneity of the patient population, and so because of the fact that we had a very robust result in our proof of concept trial for the treatment of MuSK Myasthenia Gravis, coupled with the fact that the cause of the disease, as well as the clinical presentation appears to be very homogeneous, we believe that we should see similar kinds of findings for this ongoing trial and we remain cautiously optimistic about the outcome of the current trial.

Charles Duncan, Analyst

Very good. Thanks for all the added color and look forward to gaining additional traction over the course of the year. Thank you.

Dan Brennan, CFO

Thanks Charles.

Operator, Operator

Excuse me. Thank you. Our next question is coming from Leland Gershell of Oppenheimer. Please go ahead.

Leland Gershell, Analyst

Hey, good morning, Pat, thank you for taking my questions. Congratulations on navigating this, you know, this whole situation that we're all faced with so successfully. Wanted to ask your perspective on business development activities, you know, how those may have been impacted by COVID-19 itself, perhaps by some more uncertainty around current year financials with regard to the Firdapse business, perhaps you can comment on your efforts there? And any focus that you may be directing your efforts towards in terms of, you know, particular projects or assets that may be of interest in the near future? Thanks.

Patrick McEnany, CEO

Thanks for the question, Leland. We stated earlier that we are really not looking for early-stage opportunities in terms of product opportunities, looking for later-stage beyond proof of concept. Ideally, we'd like to find projects that we could bolt-on with our sales reps meaning neuromuscular or at least in neurology in nature. Our criteria is fairly tight right now. We are seeing a fair amount of opportunities. And I think it's because we are now seeing all of these opportunities. I think also, the pandemic has probably caused us to see more opportunities than we normally would because companies are concerned about their next round of financing. And through the capital markets are open, I think the valuations are ground down pretty good. I think it's a very, very fertile environment for us to find the right opportunity of a product acquisition and/or a company at this time.

Leland Gershell, Analyst

Thank you. That’s helpful. Also, just a quick question on the Firdapse business itself, now that you've been marketed for some time, I was wondering if you could design from your experience maybe harder to do from the numbers that we see, but any particular seasonality that you've determined from Firdapse as it's launched into LEMS, and any seasonality that may affect the LEMS population or the overall neuromuscular patient population? Thank you.

Patrick McEnany, CEO

Dan, you want to take that question?

Dan Brennan, CFO

Yeah, I mean, we haven't to date seen any of that seasonality, mainly because, you know, last year in the summer months, we were really in the launch growth phase. But we would expect that the summer months would have an increased level of prescriptions just because heat actually does affect the neuromuscular junction negatively. And so, you actually have an increased symptomatology with the summer months. So, we're encouraged by that concept, and we'll be ready looking for that, but we haven't seen it thus far.

Scott Henry, Analyst

Thank you, and good morning. Just a couple questions around the launch, just trying to get my arms around it, you know, for clarity, it sounds like, you know if the churn rate is, you know, call it 15%, are you seeing really any new patients now at this point given COVID-19? I guess what I'm getting at is we, it sounds like we should expect at least some decline in 2Q versus the first quarter. Just want to make sure I am interpreting that correctly.

Patrick McEnany, CEO

Scott, let me address it, and then I'll turn it over to Dan. You know, our number of reimbursed patients on Firdapse is fairly stable and we expect that – and those that are on the drug for longer than 90 days, I'm including in that – in a category are really stable and we view that as a pretty good base. Now, people do drop out, they cancel. They unfortunately 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, we've employed a lot of new technology to reach patients and to reach physicians. And despite the fact that in April, we saw a downtick as compared to January, February, and March where we were starting to get on a roll before the pandemic. Having said that, we weren't happy with the reduction, but we are enrolling new patients. I don't want to get into numbers again. I think that over the past year, the launch year we've provided a lot of different launch metrics to investors and analysts. We thought it was important to do so. We think now the most important thing and we'll rest on our revenues as we move forward. It’s important to understand the qualitative direction of what is actually happening in the patient and physician community with Firdapse. So, again, we would all like to be sitting here with better numbers in Q2 than maybe we're seeing for the moment, but it's not falling off a cliff. And we are enrolling new patients. So Dan, you may have something you want to add to that.

Dan Brennan, CFO

I'm not sure I have much more to add unless, Scott, you had some additional color you were looking for.

Scott Henry, Analyst

No, I think that was helpful, right there. But I guess in a related question, from a pricing standpoint, are we now at a time where the revenue per patient is relatively stable as well and, you know, over time, you know, would you expect that to creep up for one reason or another? How should we think about that revenue per patient trend?

Dan Brennan, CFO

I don't see any significant changes to the revenue per patient trends.

Scott Henry, Analyst

Okay. And I guess further, any color on at least qualitatively, what you're thinking about how the Jacobus launch is proceeding, and are you noticing any impact from that relative to the last quarter, or does it remain relatively modest?

Dan Brennan, CFO

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 still becomes a minor impact, and really what matters for us and that we've seen was working, especially working with the expansion of our sales force and employing this inside sales, is communicating to many physicians who, quite honestly, are just seeing their first to second LEMS patient and are happy to hear that there's a medication available, and they're quickly getting on to Firdapse. And that's for us, getting back onto that pre-COVID trend of new patient enrollments is the name of the game.

Scott Henry, Analyst

Okay, great. And then final question, just for clarification, I think you said there were 46 new patients in the quarter, are you distinguishing between those naive to therapy, or perhaps switches who have used it prior?

Dan Brennan, CFO

Yep, for the most part, you know all of those, perhaps other than one or two, are naive previously never on Firdapse, and so these are truly patients that have either already been diagnosed and just hadn't had access to this type of great medicine or they were people that were newly diagnosed.

Patrick McEnany, CEO

Thank you for taking the questions.

Operator, Operator

Thank you. At this time, I'd like to turn the floor back over to Pat for closing comments.

Patrick McEnany, CEO

Thank you for joining us today. We look forward to further updates. Please be safe and have a great day.

Operator, Operator

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.