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spk00: The conference will begin shortly. To raise your hand during Q&A, you can dial star 11. The conference will begin shortly.
spk05: To raise your... Thank you for standing by and welcome to the Minerva Neurosciences Third Quarter 2022 Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 11 on your telephone. As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Jeff Reiss, Executive Vice President, Chief Financial Officer, and Chief Business Officer. Please go ahead, sir.
spk03: Good morning. A press release with the company's third quarter 2022 financial results and business highlights became available at 7.30 a.m. Eastern Time today and can be found on the Investors section of our website. Our quarterly report on Form 10Q was also filed electronically with the Securities and Exchange Commission this morning and can be found on the SEC's website at www.sec.gov. Joining me on the call today from Minerva are Dr. Remy Lutringer, Executive Chairman and Chief Executive Officer, and Mr. Fred Alholm, Chief Financial Officer. Following our prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind you that today's discussion will include statements about the company's future expectations, plans, and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. We caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors that are more fully detailed under the caption risk factors in our filings with the SEC, including our quarterly report on form 10Q for the quarter ended September 30th, 2022 filed with the SEC earlier today. Any forward-looking statements made on this call speak only as of today's date, Wednesday, November the 9th, 2022, and the company disclaims any obligation to update any of these forward-looking statements to reflect events or circumstances that occur after today's call, except as required by law. I would now like to turn the call over to Remy Lutringer.
spk04: Thank you, Jeff, and good morning, everyone. Thank you for joining us today. As we previously reported on August 17, 2022, we submitted our NDA for oliparidone to treat negative symptoms of schizophrenia to the FDA. The submission included the data from two clinical trials, our Phase 2b and Phase 3 studies in patients diagnosed with schizophrenia with negative symptoms. We believe that these trials are adequate and well-controlled for the purposes of submitting an NDA. The overall data set included results from two doses, 32 mg and 64 mg, administered in both studies, each of 12-week duration, double-blind and placebo-controlled. Also included was the data from the six-month open-label extension to the Phase 2b study, and data from the nine-month open-label extension to the Phase 3 study. We also provided additional supporting data requested by the FDA. Following the receipt of the refusal to file letter from the FDA in October, we have requested a Type A meeting to discuss the FDA's reasons for not accepting our NDA for substantive review. We expect the Type A meeting to occur before the end of this year, and the minutes are normally available 30 days after the meeting. I would like to make a few comments regarding our NDA for word of paradigm. First, It is important to note that there are no approved drugs in the US to treat the negative symptoms of schizophrenia, which represents a huge unmet medical need. Furthermore, to my knowledge, there are no drugs currently being developed or in clinical studies which have a specific and direct benefit on negative symptoms of schizophrenia. It is true that other drugs in development bring down negative symptoms as a function of improving positive symptoms, and side effects of antipsychotics, but none have been shown to be effective directly and specifically on disease-related negative symptoms. Furthermore, our two studies have demonstrated that by reducing the severity of negative symptoms, Roliparidone improves the overall functioning of the patient. Again, to my knowledge, Roliparidone is the only drug which has shown this effect in patients. Last but not least, it is well described in the related scientific literature that antipsychotic drugs which block dopaminergic pathways in the brain may cause drug-related worsening of negative symptoms over and above those negative symptoms which are disease-related. We believe that there is a large subset of patients diagnosed with schizophrenia who do not need continuous treatment with antipsychotics or positive symptoms yet, still suffer negative symptoms that make it difficult to lead some semblance of a normal life. Considering all of these factors from the start, we developed Roliparidone as a monotherapy for this patient's subpopulation. Having worked in clinical practice, I know there is a significant number of these patients in the community whom we have recruited and studied in our clinical trials. We have discussed with the FDA the need for a treatment for the specific subpopulation of U.S. patients, and the FDA has previously acknowledged that negative symptoms represent a significant unmet medical need. We look forward to discussing the FDA's reasons for not accepting our MDA at the Type A meeting, and we'll provide an update following that meeting. I will now turn it over to Fred for the financial update.
spk01: Thank you, Remy. Earlier this morning, we issued a press release summarizing our operating results for the third quarter ended September 30th, 2022. A more detailed discussion of our results may be found in our quarterly report on Form 10-Q filed with the SEC earlier today. Cash, cash equivalents, and restricted cash as of September 30th, 2022 were approximately $40.3 million compared to $60.9 million as of December 31st, 2021. In September 2022, we filed a shelf registration statement on form S3 to register up to $200 million in new shares of common stock. We also entered into an open market sale agreement with Jefferies LLC, pursuant to which we may offer and sell shares of our common stock from time to time through Jefferies by any method permitted by law deemed to be an at-the-market offering. During the nine months ended September 30th, 2022, no shares of our common stock were issued or sold under the agreement. As of September 30th, 2022, an aggregate of $22.6 million was eligible for sale under our effective registration statement on form S3. We expect that the company's existing cash and cash equivalents will be sufficient to meet its anticipated capital requirements for at least the next 12 months based on our current operating plan. For the three months ended September 30, 2022 and 2021, research and development expense was $2.4 million and $4.5 million, respectively, a decrease of approximately $2.1 million. For the three months ended September 30, 2022 and 2021, non-cash stock compensation expense included in R&D was $0.5 million in both periods. The nine months ended September 30, 2022 and 2021, R&D expense was $11.5 million and $13.3 million, respectively, a decrease of approximately $1.8 million. The nine months ended September 30, 2022 and 2021, non-cash stock compensation expense included in R&D was $1.5 million and $1.8 million, respectively. The decrease in R&D expense for both the three- and nine-month periods ended September 30, 2022 versus the comparable prior year periods was primarily due to lower costs for the Phase III clinical trial of Roloperidone due to the completion of the 40-week open-label extension in 2021, partially offset by higher consulting fees in support of the NDA submission in August 2022. For the three months ended September 30th, 2022 and 2021, general and administrative expense was $2.8 million and $3 million, respectively, a decrease of approximately $0.2 million. For the three months ended September 30th, 2022 and 2021, non-cash stock compensation expense included in GNA was $0.5 million and $0.6 million, respectively. For the nine months into September 30, 2022 and 2021, G&A expense was $8.7 million and $10.7 million, respectively, a decrease of approximately $2 million. For the nine months into September 30, 2022 and 2021, non-cash stock compensation expense included in G&A was $1.6 million and $2.2 million, respectively. The decrease in G&A expense for both the three- and nine-month periods ended September 30, 2022, versus the comparable prior year periods was primarily due to lower legal and insurance costs. For the three months ended September 30, 2022 and 2021, non-cash interest expense for the sale of future royalties was $1.9 million and $1.7 million, respectively, an increase of approximately $0.2 million. For the nine months ended September 30, 2022 and 2021, non-cash interest expense for the sale of future royalties was $5.5 million and $4.6 million, respectively, an increase of approximately $0.9 million. The increase in non-cash interest expense for both the three and nine-month periods ended September 30, 2022, versus the prior year periods was primarily due to interest accruing with effect from January 19, 2021, the date at which the company entered into an agreement to sell our royalty interest in Celtorexin to Royalty Pharma, as well as an increase in the underlying balance of the liability, which totaled $71.8 million at September 30, 2022. The effective interest rate is based upon estimates which contain significant assumptions regarding the timing and amount of expected royalty and milestone payments to be recognized over the royalty period. Net loss was $6.9 million for the third quarter of 2022, or net loss per share of $1.29 basic and diluted, as compared to net loss of $9.2 million, or net loss per share of $1.72 basic and diluted for the third quarter of 2021. Net loss was $25.4 million for the nine months ended September 30th, 2022, or net loss per share of $4.75 basic and diluted, as compared to net loss of $28.6 million or net loss per share of $5.36 basic and diluted for the nine months ended September 30th, 2021. Now we would like to turn the call over to the operator for any questions. Operator?
spk05: Certainly. Ladies and gentlemen, if you have a question at this time, please press star 1 1 on your telephone. One moment for our first question. And our first question comes from the line of Andrew Stein from Jefferies. Your question, please.
spk09: Hi. Thanks, and good morning. Thanks for sharing the updates and having me. So, you know, despite the RTF that you received, which is unfortunate, can we infer at this juncture whether the FDA now does feel comfortable about any of the issues they previously outlined in your prior Type C meeting? you know, the formulations, US versus XUS, MITT, the endpoint, or even Roloperidone as a monotherapy. And now the follow-up. Thank you.
spk04: Yeah, hello. So, obviously, a great question. So, I think, yes, I mean, obviously, each time you have a meeting with the FDA, you have discussions and you achieve something. So, this says, I think... because the FDA has really proposed to have this type A meeting after sending us the refusal to file. And so because we have an open dialogue, I think I would look like to comment more on what has been achieved and what has not been achieved. So we'll see what happens during this meeting. Again, the FDA has proposed to have this meeting to discuss the few items they have and we will report after we have hopefully a very good discussion with the FDA.
spk09: Thanks. And so, you know, at this juncture, it does not seem as if you would consider a new study maybe after the type, you know, if there's nothing that changes the FDA stance, then would that be the point where you consider another study. But if not, then I guess the root of my question is then when would you consider doing another study? What dynamics would have to play out first? Thank you.
spk04: I think the answer to your question is that we need to have the meeting. Again, the meeting hopefully will help to clarify the content of the NDA, yes, and hopefully we'll be able to, how to say, convince the NDA that, I mean, we have two well-adequated and controlled studies, and this is enough to have as part of the review of our NDA. So, again, I mean, let us have the meeting, and we will give you more clarity after the meeting.
spk05: Sounds good. Thank you. Thank you. You're welcome. One moment for our next question. And our next question comes from the line of Tom Schrader from BTIG. Your question, please.
spk08: Hey, good morning. This is Song from Tong. Thanks for taking our question. So kind of as a follow-up, so if you guys were required additional data before World Paradigm could be approved, like does partnership make more sense now? And then... Any other thoughts on what the trial might look like, how similar or different it may be? Or, yeah, thank you.
spk04: I think for the first part of the question, I will hand over to Jeff, yes, I mean, to give you his view, yes. But concerning the trial, again, you know, we will discuss the topics that the FDA raised in the letter we received for the refusal to file. And obviously, based on this, I mean, we will see what is next and what other additional data we can provide. So, again, keep with us, and hopefully we will have a good meeting with the FDA and have complete clarity. Jeff, can you take the first part, please?
spk02: Yeah, nothing really much to add to that, Tom. You know, I think in terms of what the path forward looks like, we'll have a whole clearer idea, a much clearer idea following the Type A meeting. And then from a strategy point of view, we can address that kind of question, whether it's necessary to do another study, whether it's best to do that study on our own, or whether it's best to do it with a partner. I think those are decisions that we'll need to take following the Type A meeting. Great.
spk08: Thank you for the color.
spk05: Thank you. Once again, if you have a question at this time, please press star 1-1 on your telephone. One moment for our next question. And our next question comes from the line of Douglas South from HC Wainwright. Your question, please. Hi, good morning.
spk07: Thanks for taking the questions. Just in getting the refuse to file letter from FDA, did they cite anything specific, or was it merely... just sort of notifying of the decision and indicating a willingness to have a type A meeting?
spk04: Great question, Doug. So normally they have always to give a reason why, yes, I mean, and these are the topics we will go to discuss. So definitely they gave a few reasons why, yes, and this is what we will discuss in the type A, definitely.
spk07: Okay, and so can you give us some, you know, would they – Again, was it largely focused on the same issues that they had, you know, raised in the previous interactions with the agency?
spk04: So I think, as I said before, I think it's not really wise to go into the details here, because we have an open dialogue and then obviously the next meeting step is this Taipei meeting. So I really would not like to comment on this. As I said before, I mean, we are making progress each time we speak. So I'm really hoping that in the Taipei meeting, we will be able to clarify the few items still open.
spk07: Okay, great. Thank you.
spk05: One moment for our next question. And our next question comes from the line of Miles Minter from William Blair. Your question, please.
spk06: Hey, just a clarification question. Did the FDA truly propose this type A meeting as a recommendation? Because my understanding is that that is a non-RTF thing to put in a letter. Or did they just sort of have commentary in there saying this is a potential path forward like it is for all RTFs? That's the first question.
spk04: No, it proposes as a type A meeting.
spk06: Okay. And then something that is in your control, I believe when you requested the type A meeting, you have to submit a list of questions that you'd like addressed in that meeting. Can you give us at least a flavour of what those lists of questions were? Because they came from you and that's not interpreting how the FTA is going to respond to them. Thank you.
spk04: No, no. So the list of questions we have is obviously extremely limited and is completely focused on what was in the letter from the FDA. So it's not new questions or whatever. It's really focusing on the few points that they raised in the letter. This is the principle of the type A milestone.
spk07: Okay. Thanks for the question.
spk04: You're welcome.
spk05: Thank you. One moment for our next question. And our next question is a follow-up from the line of Andrew Tsai from Jefferies. Your question, please.
spk09: Thanks. Just one more follow-up. Appreciate you taking the questions. You know, are you working on other assets in the pipeline? Are there next steps that we can look forward to perhaps next year? Just wanted to kind of gauge your thoughts on quote-unquote contingencies or contingency planning. Thank you.
spk04: Yeah, so great question as well. So clearly, obviously, the complete focus is on road preparedness because this is really the most important asset because it's a very late-stage asset and it is a value driver. But it is true that we have an early-stage pipeline and obviously we are moving this pipeline not as fast as we would like to have this pipeline moving, but we are moving. So, yes, indeed. I mean, if, I mean, the things are going well with this early period, which I think it will go very well, the rest of the pipeline will move technically. Yes, and we can report probably during the course of next year what we have achieved on this early stage pipeline. Absolutely. Okay.
spk09: Yep, perfect. Well, fingers crossed on the type A. Good luck. Thanks. Thank you so much. Thank you so much.
spk05: Thank you. This does conclude the question and answer session of today's program. I'd like to hand the program back to Remy Luthringer for any further remarks.
spk04: Yes, thank you so much. So really, ladies and gentlemen, this concludes our earnings call. I'm really Looking forward to give you an update after the type A meeting. So as we have mentioned, I think in our precedes, this meeting will take place before end of the year. And we have requested the meeting, sorry. And normally we get minutes 30 days later. And obviously as soon as we have clarity, we will give you all the insight we achieved and all the, how to say, what we achieved basically at the end of the day with the FDA in order to move forward. Goliperidone, which, as you know, is an extremely important drug. There's no approved drug in the United States. Thank you again for your time, and looking forward to give you the next update.
spk05: Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.
spk00: The conference will begin shortly. To raise your hand during Q&A, you can dial star 1 1.
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