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Catalyst Pharmaceuticals Inc
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Greetings and welcome to the Catalyst Pharmaceuticals Inc. Second Quarter 2018 Financial Results Conference Call . At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.
I would now like to turn the conference over to your host Aly Grande, Chief Financial Officer. Please go ahead.
Good morning, everyone. Thanks for joining our conference call. On today’s call, we have Pat McEnany, Chairman and Chief Executive Officer; Dr. Steve Miller, Chief Operating Officer and Chief Scientific Officer; and Dr. Gary Ingenito, Chief Medical Officer and Head of Regulatory Affairs.
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 the 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 which 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 in our Annual Report on Form 10-K.
At this time, it is my pleasure to turn the call over to Pat McEnany, our Chief Executive Officer.
Thank you Aly and good morning everybody. Thanks for joining us today and welcome to our second quarter 2018 results call. We are pleased to update you on our recent milestones of developments.
Steve Miller will provide a status report on our pipeline and development activities for Firdapse. And lastly Aly will review our financial results for the second quarter. We will then take your questions.
Further on future calls, we expected our new chief Commercial Officer, Dan Brennan will join us to provide you with updates about our Firdapse commercialization activities.
With that, let me start by highlighting the key takeaways from the second quarter as well as recent activities. During the second quarter of this year, we are pleased to report that the FDA had accepted for prior review our new drug application for Firdapse for the symptomatic treatment of Lambert-Eaton myasthenic syndrome or LEMS.
Priority review is granted by the FDA for drugs such as for Firdapse that has the potential to both address and provide a significant improvement in safety or effectiveness of the treatment of the condition. We are working closely with the FDA to assist them in the review process and we have received a PDUFA goal date of November 28th of this year.
Our NDA submission which is currently under active review includes the positive results from our LMS-003 confirmatory Phase III trials and patients with LEMS. Those previously announced in November of 2017. This trial achieves statistical significance for both the co-primary endpoints and the secondary endpoint.
With the FDA acceptance and review of our NDA, our focus is now on working closely with the FDA to assist them and the review process of this NDA continuing to convert enrolled patients in the LEMS and CMS expanded access program.
Pushing forward as quickly as possible with our currently ongoing clinical trials evaluating Firdapse for the treatment of congenital myasthenic syndromes, MuSK, antibody positive myasthenia gravis and spinal muscular atrophy type 3.
Preparing for the potential launch of Firdapse early next year. Completing our plans for a comprehensive patient services program to ensure that all underscored all patients who have access Firdapse and exploring other potential indications for Firdapse for other rare neuromuscular disorders.
As previously announced, we have recently appointed Dan Brennan as Chief Commercial Officer. Dan is responsible for leading sales, marketing and commercial operations as we prepare for potential launch of Firdapse in early 2019. Dan has extensive experience of leading commercial efforts at Biopharmaceutical companies particularly ones focused on rare neurological diseases.
We are excited to have him on-board and look forward to utilizing his extensive knowledge in the commercialization of our therapeutics for rare neuromuscular disorders. Dan shares the same passion as the rest of the Catalyst see and bringing safe and effective therapies for patients suffering from rare diseases.
Since joining us in June, Dan has already made great progress in building our commercial leadership team. On Monday, we announced that we have added several key senior leadership positions to the commercial operation, which will be an integral part of our plan for potential launch of Firdapse.
These includes, Senior Vice President of Commercial Operations and Analytics, Senior Vice President of Sales and Marketing, Senior Director of Patient Services, and Senior Director of Patient Efficacy and Engagement. This talent team has extensive experience of launching treatments for a number of rare neurological disorders.
Additionally, we have recently hired three additional Senior Medical Science Liaison that have a wealth of experience and working within the neuromuscular physician community. This brings a number of MSLs currently on our Medical Affairs Team to five.
Lastly, as part of our patient services program, we have finished our manufacturing plans to assure that all patients who have access to Firdapse assuming approved. We are also developing a program to assist patients who are in our extended access program with an easy and smooth transition to the commercial product, once we launch the product.
To ensure that the transition is a positive experience, we have already begun the progress to manufacture adequate supplies of commercial product to meet the expanded requirements of all of these patients.
I will now turn the call over Steve Miller, our Chief Operating Officer and Chief Scientific Officer, who will provide more information about our development programs.
Thank you, Pat and good morning everyone. As Pat previously mentioned, our NDA for the symptomatic treatment of LEMS was accepted by the FDA and is under active review at this time. The NDA was granted priority review and was assigned the PDUFA goal date of November 20 of this year. Catalyst remains hopeful that the NDA will be approved on or about this call date.
As we previously announced, the NDA submission that we filed in March is only for Firdapse for the treatment of LEMS and did not include an indication for the limited subtypes of the congenital myasthenic syndromes or CMS that are mechanistically similar to LEMS.
Catalyst continues to work diligently and conducting our Phase 2 trial evaluating Firdapse in patients with CMS in order to collect additional safety and efficacy data in both adult and pediatric CMS patients.
Enrollment for the CMS trial was currently ongoing and we anticipate top-line results in the first half of 2019. Assuming successful top-line results, Catalyst anticipates meeting with the agency to discuss the suitability of the clinical results, as well as the structure content of the supplement to include a general CMS indication in the Firdapse label pending a successful outcome of such amazing Catalyst hope to filed a supplement to its NDA for the additional CMS indication.
We also continue to enroll patients in our Phase 3 trial evaluating Firdapse for the treatment of MuSK antibody positive myasthenia gravis or MuSK-MG. This trial has being conducted under an FDA special protocol assessment or SPA.
We look forward to continuing enrollment and expect top-line results in the second half of 2019. This Phase 3 trial is a confirmatory clinical trial that Catalyst hopes will confirm and expand on the previously announced positive results of a proof-of-concept trial that was reported in early 2017.
Catalyst is hopeful, that is confirmatory trial is successful that it together with the results of the previously reported proof-of-concept study will provide adequate evidence of safety and efficacy for the MuSK-MG indication that Catalyst hopes to include in the Firdapse label by way the future supplement to its already approved NDA.
As previously reported, Catalyst has been granted Orphan Drug Designation for Firdapse, the treatment of myasthenia gravis. We have recently initiated a proof-of-concept trial of Firdapse in spinal muscular atrophy or SMA type 3. And expect to dose on first patient in the second half of 2018. This trial will be conducted in Europe and we expect to enroll approximately 12 patients. We look forward to announcing top-line results from this trial in the second half of 2019.
As we continue to support our Expanded Access Program, which provides amifampridine phosphate tablets to patients with LEMS and CMS. In these cases, amifampridine phosphate tablets are provided free of charges, if the patients have no other treatment option and their physicians believe that this treatment could provide relief to their patients.
I will now turn the call over to Aly Grande, our Chief Financial Officer to review your financial results.
Thanks Steve. All reference to per share in this call refers to basic and diluted shares. For the quarter ended June 30, 2018 Catalyst reported a GAAP net loss of 6 million or $0.06 per share compared to a GAAP net loss of 3.9 million or $0.05 per share for the same period in 2017.
For the first quarter of 2018, non-GAAP net loss was the same as GAAP net loss as there were no non-GAAP adjustments. Excluding our non-cash gain of 210,000 attributable to a change in fair value of liability classified warrant. Non-GAAP net loss was 4.1 million or $0.05 per share for the second quarter of 2017.
Research and development expenses was 3.7 million for the second quarter of 2018 compared to 2.5 million for the same period in 2017. The increase in R&D when compared to the same period in 2017 was principally due to increases in consulting expense, milestone expenses in connection with the acceptance of our NDA submission in May 2018.
Expenses from our Medical Affairs Program and compensation and related personnel costs, as we expand our headcount to support currently ongoing trials and programs. We expects that that research and development costs will continue to be substantial during the balance of 2018 as we work towards completing trials evaluating Firdapse for the treatment CMS and MuSK-MG and SMA type 3 continues Expanded Access Program for Firdapse and all development program and process are recently accepted in this nation with Firdapse for LEMS.
General and administrative expenses for the second quarter of 2018 totaled 2.6 million compared to 1.7 million in the second quarter of 2017. The increase when compared to the same period 2017 is primarily due to increases in pre-commercialization expenses, headcount and corporate expenses as we build up our infrastructure and commercial programs in preparation for potential trade off launch in 2019.
We have set the G&A cost including pre-commercialization cost will continue to increase in 2018 compared with the G&A cost incurred in 2017 as we continue to expand our operations in preparation for a potential launch in 2019. That always had no revenue, neither the second quarter of 2018 or 2017.
At June 30, 2018, Catalyst have cash in investments of $73.4 million and no debt. Although there can be no assurance when we related to these resources will be sufficient to support our planned operations through 2018 without comparing revenues and cash received that we might received in 2019 if we are successfully updating and [indiscernible] on launching the product in 2019.
More detailed information on our analysis maybe found in the Company's quarterly report in Form 10-Q which was filed with the Securities and Exchange Commission yesterday August 7, 2018 and can be found on the Investor Relations page of our website at www.catalystpharma.com.
I will now turn the call back to Pat.
Thanks Aly. The Catalyst team is highly motivated with the acceptance of our NDA and its receipt of a prior day reviewing. We are working closely with the FDA to assist them in their review of our NDA and we look forward to the potential approval of our NDA for Firdapse for the treatment of LEMS and bringing treatment LEMS community and FDA approved therapy.
We are also pleased about the progress we are making in evaluating Firdapse for additional indications. Finally, we are excited to have expanded our commercial leadership team and are grateful for the experience these new hires bringing commercialization activities for therapies for rare and neurological diseases.
We are confident that we are taking the steps necessary for a successful commercial launch of Firdapse for LEMS pending FDA approval. We also look forward to providing you with any additional update on our other pipeline and business development activities as they become available.
This will end the formal presentation and we will turn the call over to the operator for questions.
Thank you sir. At this time we will be conducting a question-and-answer session. [Operator Instructions] Our first question today comes from Edward Nash of SunTrust Robinson Humphrey. Please go ahead.
Great. Thanks so much for taking my call. And I want to welcome Dan to the team. Nice to have you onboard. I wanted to start maybe Pat, maybe you could see - I know we have discussed this before. But as we are getting now closer to that PDUFA or Steve what are your guys thoughts on the [Adcom] (Ph)? Do you still see a little bit - there won't be an [Adcom] or how do you feel about that?
We don’t believe there is going to be an Adcom and that is based on the communications with the FDA. So it's unlikely let’s put it that way.
Okay. And then can you just remind us with regard to the - I appreciate the update on the timing for the CMS in the MuSK-MG trials. But could you just remind us again, the number of patients that you target enrollment per each and what the primary end points for both?
Steve, would you like to take that?
Sure. For the CMS trial, the target enrollment is about 20 patients. The endpoints is MFM or Motor Function Measure, and SGI. And for the MuSK-MG trial, the target enrollment is 60 patients and the primary endpoint is MGADL or myasthenia gravis activities of daily living.
Okay, great. And the SMA trial, you said they will start in the second half of this year?
Yes, it will.
Okay and so that trial based on that data that you will get from that trial. I assume you would still need to move on to do a second study, or is there any chance that based on positive data that trial could be potentially filed for accelerated approval?
No. we believe that that will actually require second trial. The design of the trial does not include a duration of treatment that is long enough to assess whether or not Firdapse would reduce the progression of the SMA disease.
Okay. And then my last question I will jump off. With regard to the CMS in the MuSK-MG indications or both of those would be supplemental filing, supplemental NDA findings?
That is correct. Our NDA that is currently being review by the FDA is only for the LEMS indication. Any new indications that we add would be supplements to already approved NDA.
Okay. Great, thank you guys so much.
Thanks Edward.
The next question is from Scott Henry of Roth Capital. Please go ahead.
Thank you and good morning. First question Pat. Now that NDA Firdapse has been accepted. Can we assume, does that puts the whole jack a bus risk kind of to bed in terms of them beating you to a filing? Is that by being accepted? Is that now clear?
Well, technically, I don’t believe it is Scott. I think that again, they are a privately held company. So we don’t know where they are - if they are at all pursuing in NDA. And so until you receive your approval it’s really not game set match. So and again there is not very much public information out there about where they are. The only information we get is really anecdotal and it’s from MSOs who are in this year calling on the KOLs and the LEMS experts. And so, we are moving ahead and we expect that we will be approved by the PDUFA date.
Okay great. Thanks for that clarity. And then with regards to the model, I thought we may see the 2.6 million milestone in Q2. I gather will that be fully expensed in Q3 or is it possible of the amortize. How should we think about that 2.6 million?
We have actually renegotiated that in the 10-Q Scott with the [actually] (Ph) shareholders who are parties to the to the license who would [indiscernible]. And so renegotiated that and the milestones have changed. And those detailed are laid out in the queue. And so we did pay a $1 million and that did hit --.
In Q3.
That is a Q3 expense. Even though it occurred and reserved when we signed an amendment to that agreement.
Yes if you are referring to the milestone upon approval of the NDA. We will reach…
He is talking about the acceptance to $2.6 million.
Yes. We only paid a portion of that. And that has been recorded on Q2.
It's been renegotiated Scott favorably for us.
Yes.
Okay. Great. I will take a look at the 10-Q. I did see that appendix at the end. And then as far as the G&A, approximately how much of that is selling in 2Q? And any color on how much you would see selling expenses at sort of the steady state?
Yes. I don't know fairly you have that that's [indiscernible], but I expected that from you Scott. So we have got that number. Of the $5.3 million in G&A that we have for six months, $1.5 million was that selling expense. That once approved that will then shift to the selling expense and not in G&A.So if you backed out the 1.5, we were 3.8 outside of selling expense.
Okay, great. Thank you for taking the questions.
Okay, thanks Scott.
[Operator Instructions] Our next question comes from [Arrie Gold] (Ph) of Oppenheimer. Please go ahead.
Hi this is Arrie Gold on for [Levin] (Ph) at Oppenheimer. Thanks for taking my question.
Hi, good morning.
Good morning. I understand you are looking to monetize your legacy drug assets. Just wanted to know how progress has been on that front?
We don't have any new information to report at this time. We have been seeing this for a while, but we think we are fairly close to monetizing at least one of those assets. And the other we are currently in a little bit of a dispute over our license with Northwest and we are hoping to amicably resolve that in the very near future. The generic Sabril asset we are making a great deal of progress on the regulatory front. And as we do that it makes it more likely that we will then be in a position of monetize that or partner it.
Okay. Thank you.
There are no further questions at this time. I would like to turn the call back over to Patrick McEnany for closing remarks.
Thank you all for your participation in this morning's call. We are pleased with the progress we have achieved and anticipate the balance of 2018 to be an exciting year for us. And thank you again for your shareholder support as we move forward with our progress. Thank you.
This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.