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Edited Transcript of CPRX.OQ earnings conference call or presentation 12-May-20 12:30pm GMT

Q1 2020 Catalyst Pharmaceuticals Inc Earnings Call

Coral Gables Jun 19, 2020 (Thomson StreetEvents) -- Edited Transcript of Catalyst Pharmaceuticals Inc earnings conference call or presentation Tuesday, May 12, 2020 at 12:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Alicia Grande

Catalyst Pharmaceuticals, Inc. - VP, Treasurer & CFO

* Daniel J. Brennan

Catalyst Pharmaceuticals, Inc. - Chief Commercial Officer

* Patrick J. McEnany

Catalyst Pharmaceuticals, Inc. - Co-Founder, Chairman, President & CEO

* Steven R. Miller

Catalyst Pharmaceuticals, Inc. - COO & Chief Scientific Officer

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Conference Call Participants

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* Charles Cliff Duncan

Cantor Fitzgerald & Co., Research Division - Senior Analyst

* Joseph Michael Catanzaro

Piper Sandler & Co., Research Division - VP & Senior Biotech Analyst

* Leland James Gershell

Oppenheimer & Co. Inc., Research Division - MD & Senior Analyst

* Scott Robert Henry

Roth Capital Partners, LLC, Research Division - MD, Senior Research Analyst & Head of Pharmaceuticals Research

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Presentation

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Operator [1]

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Greetings, and welcome to the Catalyst Pharmaceuticals First Quarter 2020 Results Conference. (Operator Instructions) As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Ali Grande, CFO.

Thank you. You may begin.

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Alicia Grande, Catalyst Pharmaceuticals, Inc. - VP, Treasurer & CFO [2]

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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, Chief Commercial Officer.

Before we begin, I would like to remind you that in the following comments, and in the Q&A session, we will make statements about expected future results, which may be forward-looking statements for purposes of federal securities laws. These statements relate to our current expectations, estimates and projections and are not guarantees of future performance. They involve risks, uncertainties and assumptions that are difficult to predict and may prove not to be accurate. Actual results may vary. These forward-looking statements should be considered only in conjunction with the detailed information contained in our SEC filings, including the risk factors described in our annual report on Form 10-K.

At this time, I'll turn the call over to Pat.

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Patrick J. McEnany, Catalyst Pharmaceuticals, Inc. - Co-Founder, Chairman, President & CEO [3]

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Thanks, 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 the health care providers and patient communities.

In addition, we at Catalyst 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 have 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 base that is on reimbursed Firdapse is fairly stable.

Remember that LEMS is a chronic disease and Firdapse is an oral medication administered at home and delivered monthly to the patient's residents. However, we expect that there will be some headwinds in the second quarter when it comes to new patient starts for Firdapse. Based on what we have seen to date, we expect some level of disruption associated with delayed diagnosis and new patient starts. This is driven by data that suggests the patient visit to physicians' offices are down by about 70%.

Additionally, as mentioned earlier, we implemented a no-travel policy for our 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 are 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 COVID-19 pandemic on our operations or financial results, we've decided that it is best to withdraw the 2020 net revenue guidance that we provided earlier this year. The extent of the impact of COVID-19 on our business for the remainder of 2020 will be driven primarily by the severity and duration of the pandemic. While we have adopted many practices to mitigate the impact of the disruption, at this time, it's too difficult to reasonably estimate how the pandemic will ultimately affect Firdapse revenues.

Dan will 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 and in some cases, life-threatening disease and patients will continue to seek and receive treatment for LEMS.

Earlier, we said that our safety stock of Firdapse includes manufactured and packaged product that takes us to midyear 2021. Also, we have active pharmaceutical ingredient, or API, in stock and campaigns are underway for additional API that should carry us through 2023. We have several qualified finished dosage form contract manufacturers in place, and each of them has contingency plans in the event that one is required. It is important to note that our entire supply chain is based in the United States.

In our April late press release, we provided an update on our clinical development time lines. At that point in time, we still expected to announce Phase III results for our MuSK-MG trial in the first half of this year. Since then, we have seen that the pandemic has caused many clinical trial sites in the U.S. and Europe to temporarily suspend their clinical trial activities and redeploy staff members to provide care for COVID-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 FDA's recent provision for guidance for conducting clinical trials during the COVID-19 pandemic is helpful, several of the site closeout activities need to be conducted in person by Catalyst or clinical research organizational staff at the site. As soon as it is safe for our CRA and contractors to travel, and once the sites are able to meet with study sponsors, we'll be on the doorsteps to wrap up this trial.

After completing a closeout visit at all the trial sites, we'll then be in a position to lock the database and begin to analyze the data and generate the top line data to report on.

Based on all of these factors, we now believe that we'll be in a position to announce top line 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 of MuSK-MG later this year or early next year.

As previously announced, due to COVID-19 restrictions imposed by the Serbian government, our recruited and screened SMA Type 3 study subjects at the site will not be able to start as originally scheduled. Because of this, the study has been delayed, and based on available information, we now expect to have top line 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 on our geographic expansion efforts for Firdapse in Japan and Canada. Last quarter, we announced that we have submitted our NDS of Firdapse for LEMS in Canada, which was accepted and granted a Priority Review. We expect the potential approval of this NDS in the second half of this year. We are also in early discussions with potential marketing partners in both Canada and Japan.

Expansion of product offerings and diversifying our pipeline remains a critically important part of our strategic plan. David Ailinger, our Vice President of Business Development, has been very engaged in reviewing potential transactions for partnering and for products and/or companies to acquire that will represent a good strategic fit for us. However, no agreements have been entered into to date.

To a small degree, the pandemic has also slowed the progress of our lawsuit against the FDA regarding their unauthorized approval of Ruzurgi. A hearing had been scheduled in March on a number of procedural issues, but was delayed until mid-April due to the COVID-19-related obstacles on the magistrate's docket. Those procedural issues have been resolved and the case is proceeding to what appears to be a final briefing which will take place. At that point, we'll 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 that Catalyst became a corporate partner with the first responders, Children's Foundation, COVID-19 Emergency Response Fund. This fund provides financial assistance to the families of emergency and health care workers that are on the front line during this COVID-19 pandemic. We are honored to be part of this very important cause.

I'll now turn the call over to Dan Brennan, our Chief Commercial Officer, to provide you with details on our commercial operations.

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Daniel J. Brennan, Catalyst Pharmaceuticals, Inc. - Chief Commercial Officer [4]

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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 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 20-plus enrollments since mid-last year, but as Pat mentioned, on March 16, we pulled our sales force 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 2 separate key risk factors making them susceptible to severe COVID-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.

As Pat already indicated, our first quarter net sales of $29.1 million was 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 the medication in an ultra-rare disease area with patients changing insurance carriers, the reset of deductibles and new co-payment applied 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.

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 and 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 LEMS community, and we are happy to report that not 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. Our co-pay and financial support programs continue in full force, and the Q1 average out-of-pocket was $1.09 per patient per month. We have increased our use of social media as another way to update communication to the LEMS community. The customer service levels and ratings remain as high as they have ever been. This is a true 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 e-mail 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 newly created digital educational materials that are approved for e-mail use responding to physician questions and requests.

While these are challenging times, we remain confident in the ability of our team to bring Firdapse to physicians and adult LEMS patients. We remain confident that our Catalyst Pathways programs will continue to help any adult LEMS patient who needs Firdapse to obtain it regardless of their insurance coverage or ability to pay.

We are 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 MuSK-positive Myasthenia Gravis as we work to expand Firdapse's indications in the coming months and years.

I will now turn the call over to Dr. Steven Miller, our Chief Operating Officer and Chief Scientific Officer, for an update on R&D activities.

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Steven R. Miller, Catalyst Pharmaceuticals, Inc. - COO & Chief Scientific Officer [5]

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Thanks for the commercial update, Dan. And now I'll provide an update on our clinical pipeline to develop Firdapse for additional neuromuscular indications.

First, I will turn to our Phase III trial in 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 III trial, and I'm pleased to report that we've 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 top line results will 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 was recently described by the White House, will be a more gradual 3-phase process. These prolonged restrictions are delaying the completion of required regulatory clinical trial closeout activities prior to unblinding and reporting of top line results, and 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, Catalyst 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 where our most research sites are closed.

As we previously mentioned, we remain cautiously optimistic about the outcome of this Phase III trial as MuSK-MG is a relatively homogeneous disease, and we're hopeful that the response to treatment will be similar to our previous proof-of-concept trial.

Assuming positive results of this Phase III 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 U.S. 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 COVID-19 health emergency. But we were able to provide -- but we were unable to provide guidance on future reporting date due to the unknowns at that time regarding the easing of COVID-19-related restrictions. We now believe that 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 2-week treatment time in each period, and it's 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 4 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 III clinical trial with the FDA, in which we intend to address both symptomatic treatment and disease progression in perhaps more than 1 type of SMA.

Moving on to market expansion plans for Firdapse. The review of Catalyst pending new drug submission in Canada for the treatment of LEMS is ongoing. Catalyst was granted Priority Review for this drug NDS, which will be -- which will reduce the review cycle time to 6 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 3 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-acting 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 the long-acting symptomatic treatment of LEMS.

Due to the types of activities that were ongoing in the first half of 2020, the COVID-19 health emergency has had no effect to the date and 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 impacts that this global health crisis is having on our time lines, 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 Ali Grande, our Chief Financial Officer, to review our financial results.

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Alicia Grande, Catalyst Pharmaceuticals, Inc. - VP, Treasurer & CFO [6]

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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 noncash 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 noncash stock-based compensation, was $289,000 or $0.00 per basic and diluted share.

Net product revenue for Firdapse, which was launched during 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 -- from Firdapse was $12.4 million with 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, manufacture and expense prior to the FDA approval of Firdapse.

Research and development expenses were $4.2 million for the first quarter of 2020 as 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, our quality assurance programs, expenses from our ongoing Firdapse clinical trials and studies, and cost for 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 our sustained release formulation program for Firdapse, begin to evaluate Firdapse as a treatment for other neuromuscular diseases and assuming positive results from the trial, prepare 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 noncash stock 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 and 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 at www.catalystpharma.com.

Now I'll turn the call over to Pat.

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Patrick J. McEnany, Catalyst Pharmaceuticals, Inc. - Co-Founder, Chairman, President & CEO [7]

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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, health care providers and the broader community.

We started off 2020 with a 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?

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question is coming from Joe Catanzaro of Piper Sandler.

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Joseph Michael Catanzaro, Piper Sandler & Co., Research Division - VP & Senior Biotech Analyst [2]

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Maybe first, a couple 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 were actively receiving insurance-reimbursed 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?

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Daniel J. Brennan, Catalyst Pharmaceuticals, Inc. - Chief Commercial Officer [3]

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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.

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Joseph Michael Catanzaro, Piper Sandler & Co., Research Division - VP & Senior Biotech Analyst [4]

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Yes. 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?

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Daniel J. Brennan, Catalyst Pharmaceuticals, Inc. - Chief Commercial Officer [5]

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Yes. I mean, we're trying to -- now that we're through the launch year, and we are 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 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, 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 due to 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 are hoping and ultimately with the previous guidance, we need to be in the neighborhood of 15 to 20 patients -- new patient enrollments per month in order to get that type of growth.

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Joseph Michael Catanzaro, Piper Sandler & Co., Research Division - VP & Senior Biotech Analyst [6]

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Okay. Got it. That's very helpful. And if I could just ask one follow-up, Dan. I think you also mentioned that there was maybe an uptick in long-term -- 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?

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Daniel J. Brennan, Catalyst Pharmaceuticals, Inc. - Chief Commercial Officer [7]

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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 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 with us. We communicated in advance. And so the impact really is somewhere in the $1 million to $1.5 million range, which will ultimately resolve throughout the rest of the year.

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Operator [8]

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Our next question is coming from Charles Duncan of Cantor Fitzgerald.

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Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division - Senior Analyst [9]

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Thanks for all the information, and appreciate the challenges that you have as there's a lot of folks in terms of managing this current pandemic. I wanted to ask you a question and then a couple for Dan and maybe one for Steve. With regard to U.S., as you think about whether or not to withdraw versus widened guidance, I'm wondering if withdrawing is an abundance of caution? Or are you seeing anything new? Just kind of let us know your philosophy on why now you would withdraw versus widened guidance.

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Patrick J. McEnany, Catalyst Pharmaceuticals, Inc. - Co-Founder, Chairman, President & CEO [10]

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Yes. 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 in this environment and leaving that guidance out at $1.35 to $1.55, 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 1 month or 2 or 3 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, we felt it was the prudent thing to do. It's nothing more than that. It's -- there is no trend. In fact, 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.

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Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division - Senior Analyst [11]

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Yes, 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 with -- 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.

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Daniel J. Brennan, Catalyst Pharmaceuticals, Inc. - Chief Commercial Officer [12]

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Well, I mean, it mainly gets to staying in contact with physicians and continuing to remind them that patients with rare disease have significant issues. And so we're doing that and quickly move 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 drives 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 the physicians and patients just aren't seeing each other during this time.

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Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division - Senior Analyst [13]

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Makes 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?

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Daniel J. Brennan, Catalyst Pharmaceuticals, Inc. - Chief Commercial Officer [14]

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Well, it's -- it really does depend upon the physician and the system that they're in and the hospital to some extent.

I mean it's all over the board. You have physicians perhaps in academic centers that are overrun with COVID and they've completely shifted resources, they don't want to talk to anyone. And you have others that are like, yes, I have some time to talk, and I appreciate your willingness to provide this 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 e-mail and will reach out to us and talk to our 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 to 1.5 weeks, where patients are actually still getting diagnosed and whether that be continuing to get antibody tests or EM testing, we're pleased to see that, that's still happening. But Charles, it's really all -- it's all over the board.

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Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division - Senior Analyst [15]

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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 kind of view on the conduct of that study. I 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?

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Steven R. Miller, Catalyst Pharmaceuticals, Inc. - COO & Chief Scientific Officer [16]

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Well, thanks, Charles. As I mentioned in my opening remarks, the patient population is relatively homogeneous for MuSK. And by that, I meant 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 quite a bit of homogeneity and 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 properties related to the disease.

Now 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 -- 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 2 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 disease -- 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.

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Operator [17]

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Our next question is coming from Leland Gershell of Oppenheimer.

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Leland James Gershell, Oppenheimer & Co. Inc., Research Division - MD & Senior Analyst [18]

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Congratulations on navigating this whole situation that we're all faced with so successfully. I wanted to ask your perspective on business development activities. How those may have been impacted by COVID-19 itself, perhaps by maybe 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 toward in terms of particular projects or assets that may be of interest in the near future?

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Patrick J. McEnany, Catalyst Pharmaceuticals, Inc. - Co-Founder, Chairman, President & CEO [19]

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Yes. Thanks for the question, Leland. We have 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. And so our criteria is fairly tight right now. We are seeing a fair amount of opportunities. And I think it's because of Dave's extensive Rolodex that 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 though the capital markets are open, I think the valuations are ground down pretty good.

And so I think it's a very fertile environment for us to find the right opportunity of a product acquisition and/or a company at this time.

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Leland James Gershell, Oppenheimer & Co. Inc., Research Division - MD & Senior Analyst [20]

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That's helpful. And also just a quick question on the Firdapse business itself. Now that you've been in market for some time, I was wondering if you could define 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?

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Patrick J. McEnany, Catalyst Pharmaceuticals, Inc. - Co-Founder, Chairman, President & CEO [21]

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Dan, you want to take that question?

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Daniel J. Brennan, Catalyst Pharmaceuticals, Inc. - Chief Commercial Officer [22]

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Yes. I mean we haven't to date seen any of that seasonality, mainly because last year, in the summer months, we were really in the launch growth phase and -- 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 at looking for that. But we didn't -- we haven't seen it thus far.

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Operator [23]

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Our next question is coming from Scott Henry of Roth Capital.

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Scott Robert Henry, Roth Capital Partners, LLC, Research Division - MD, Senior Research Analyst & Head of Pharmaceuticals Research [24]

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Just a couple of questions around the launch. Just trying to get my arms around it. For clarity, it sounds like if the churn rate is, 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 -- it sounds like we should expect at least some decline in 2Q versus first quarter. Just want to make sure I am interpreting that correctly.

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Patrick J. McEnany, Catalyst Pharmaceuticals, Inc. - Co-Founder, Chairman, President & CEO [25]

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Scott, let me address it, and then I'll turn it over to Dan. Our reimbursed -- number of reimbursed patients on Firdapse is fairly stable. And we expect that -- and those that are on drug for longer than 90 days, I'm including in that category, are really stable, and we view that as a pretty good base. Now people do drop out, they cancel, they discontinue, they -- unfortunately, some pass away. But that's a fairly stable number. And albeit 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. And 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 to analysts and 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. 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'd all like to be sitting here with better numbers in Q2 than maybe we're seeing for the moment. But I it's not flowing off a cliff, and we are enrolling new patients. So Dan, you may have something you want to add to that?

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Daniel J. Brennan, Catalyst Pharmaceuticals, Inc. - Chief Commercial Officer [26]

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

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Scott Robert Henry, Roth Capital Partners, LLC, Research Division - MD, Senior Research Analyst & Head of Pharmaceuticals Research [27]

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

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Daniel J. Brennan, Catalyst Pharmaceuticals, Inc. - Chief Commercial Officer [28]

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

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Scott Robert Henry, Roth Capital Partners, LLC, Research Division - MD, Senior Research Analyst & Head of Pharmaceuticals Research [29]

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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?

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Daniel J. Brennan, Catalyst Pharmaceuticals, Inc. - Chief Commercial Officer [30]

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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 what we've seen was working and 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 or second LEMS patient and are happy to hear that there's a medication available and they're quickly getting on to Firdapse. I mean that's, for us, getting back onto that pre-COVID-19 trend of new patient enrollments is the name of the game.

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Scott Robert Henry, Roth Capital Partners, LLC, Research Division - MD, Senior Research Analyst & Head of Pharmaceuticals Research [31]

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Okay. Great. And then a 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 switchers who had used it prior?

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Daniel J. Brennan, Catalyst Pharmaceuticals, Inc. - Chief Commercial Officer [32]

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Yes. For the most part, yes, all of those, perhaps other than 1 or 2, are naive, previously never on 3,4-DAP. 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.

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Operator [33]

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

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Patrick J. McEnany, Catalyst Pharmaceuticals, Inc. - Co-Founder, Chairman, President & CEO [34]

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

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Operator [35]

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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.