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Edited Transcript of ZGNX earnings conference call or presentation 6-Aug-19 8:30pm GMT

Q2 2019 Zogenix Inc Earnings Call

SAN DIEGO Aug 11, 2019 (Thomson StreetEvents) -- Edited Transcript of Zogenix Inc earnings conference call or presentation Tuesday, August 6, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Ashish M. Sagrolikar

Zogenix, Inc. - Executive VP & Chief Commercial Officer

* Michael P. Smith

Zogenix, Inc. - Executive VP, CFO, Treasurer & Secretary

* Stephen J. Farr

Zogenix, Inc. - Co-Founder, CEO, President & Director

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Conference Call Participants

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* Alexander Lim

Mizuho Americas Llc - MD & Head of Investment Banking

* David A. Sherman

LifeSci Advisors, LLC - Director of Research

* Jason Nicholas Butler

JMP Securities LLC, Research Division - MD and Senior Research Analyst

* Lachlan Hanbury-Brown

William Blair & Company L.L.C., Research Division - Associate

* Nirav Y. Shelat

Piper Jaffray Companies, Research Division - Research Analyst

* Roanna Clarissa H. Ruiz

SVB Leerink LLC, Research Division - Associate

* Sadia Rahman

BofA Merrill Lynch, Research Division - Research Analyst

* Yatin Suneja

Guggenheim Securities, LLC, Research Division - MD & Senior Biotechnology Analyst

* Brian Ritchie

LifeSci Advisors, LLC - MD

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Presentation

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Operator [1]

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Greetings, and welcome to the Zogenix Second Quarter 2019 Financial Results Conference Call. (Operator's Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Brian Ritchie. Please go ahead.

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Brian Ritchie, LifeSci Advisors, LLC - MD [2]

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Thank you, operator, and thank you all for joining us this afternoon. With me on today's call are Chief Executive Officer, Dr. Stephen Farr; and Chief Financial Officer, Michael Smith. Ashish Sagrolikar, Chief Commercial Officer, will also be available during the Q&A session.

This afternoon, Zogenix issued a news release announcing financial results and providing a business update for the 3 and 6 months ended June 30, 2019. Please note that certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, Zogenix management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Zogenix' news releases and SEC filings, including in the annual report on Form 10-K and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, August 6, 2019. Zogenix undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.

Now I'd like to turn the call over to Steve.

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [3]

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Thank you, Brian, and good afternoon to everyone who's joining us on today's call. Since our last investor call, we are very pleased to have made positive strides in advancing both our key FINTEPLA programs: first, in reaching an agreement with the FDA in regard to the NDA resubmission for Dravet syndrome; and second, in completing patient enrollments into our global Phase III study for Lennox-Gastaut syndrome or LGS. These are 2 childhood-onset epilepsies that can present life-long difficulty to patients and their families. As a reminder, FINTEPLA is the brand name of our lead drug candidate, ZX008 or fenfluramine.

As previously announced, following a constructive meeting with the FDA at the end of May, we now have a clear understanding and defined path forward for the resubmission of the FINTEPLA NDA for the treatment of seizures associated with Dravet syndrome. With the FDA's concurrence, we are able to submit the NDA without the additional chronic toxicity studies specified in the agency Refusal to File or RTF letter which we received in early April.

In addition, we have resolved the data set issue also noted in the RTF letter and have implemented a remediation and validation plan agreed upon with the FDA for the resubmitted data sets. It's important to reinforce that the study results were determined using the correct data set unless unfortunate error was limited to uploading an incorrect clinical data set to the submission portal.

Working through these issues with the FDA highlighted the strong support by physician and care giver communities for FINTEPLA as a potential future treatment option in Dravet syndrome, and we are on track to resubmit the NDA in September.

In parallel to our U.S. regulatory activities, I'm pleased to report that the European regulatory applications for FINTEPLA for the treatment of seizures associated with Dravet syndrome remains under active review. We are currently assuming priority review for our forthcoming FINTEPLA NDA resubmission and correspondingly are preparing to launch FINTEPLA in the United States in the first half of 2020.

To ensure commercial readiness, we have a number of ongoing activities, such as interacting with clinicians and the Dravet community to increase our understanding on critical treatment and care needs, including the continued demand for new, more efficacious and better-tolerated treatment options for many patients and also discussing the investigational FINTEPLA data generated to date.

As part of these efforts, we are increasing our level of engagement with community stakeholders, physicians and advocacy groups through meetings, medical conferences and medical education programs. And during the remainder of 2019, Zogenix will have a significant presence at several upcoming U.S. and European medical meetings, such as the European Pediatric Neurology Society in September and the Child Neurology Society in October and the American Epilepsy Society in December.

We also recently launched a Dravet awareness campaign in United States, including a website, draveturgency.com, designed to help clinicians understand the need for both improved seizure control and better quality of life of patients and their families.

Turning to product manufacturing. During the second quarter, we finalized commercial scale validation on our suppliers for both the drug substance and the finished drug product. We're also pleased to report that distribution via specialty pharmacy has been established and is already up and running and supplying drug to patients participating in our Expanded Access Program or EAP. We are encouraged by the strong interest and participation we have seen from the Dravet community in both our EAP and the ongoing open-label extension studies.

In total, there are currently 380 Dravet patients being treated with FINTEPLA across these programs. More than 260 of these patients have now been on FINTEPLA for at least 1 year, which continues to show a favorable safety profile and no incidence of valvular heart disease.

I'd now like to move on to our work in Lennox-Gastaut syndrome or LGS, another difficult-to-treat severe childhood-onset epilepsy, for which new and more effective treatments are urgently needed. As I mentioned earlier, we announced last month that we have completed enrollments for and randomized the last of 263 patients into the treatment period of Study 1601. As a reminder, this Phase III trial is an ongoing, global, double-blind, placebo-controlled, 3-arm trial in subjects between 2 and 35 years of age. We expect the top line safety and efficacy data in LGS from Study 1601 will be available in the first quarter of 2020.

In addition to our recent regulatory development and commercial preparedness activities, we're also pleased to report that our intellectual property position has strengthened through the recent notice of allowance for 1 U.S. patent application and the issuance of 2 new U.S. patents. The allowed patent application covers the safe use of fenfluramine for epilepsy treatment and the 2 issued patents cover the propriety synthetic process we use to manufacture fenfluramine. The granting of these patents will bring our issued U.S. patent portfolio for FINTEPLA to 7, which in combination with our international patent portfolio and global regulatory market exclusivity factions also provide proprietary protection up to 2036 and potentially beyond.

Earlier this year, we discussed plans to initiate a randomized control study of FINTEPLA in Doose syndrome. In response to input from members of the advisory boards, we engaged to prepare for this study, we stressed the urgent need for new treatments in several exploratory study of FINTEPLA in several severe epilepsy syndromes, including Doose syndrome. We expect this study to begin late in this year and look forward to providing further information in the coming months.

In conclusion, we made good progress in multiple regulatory development, medical affairs and commercial areas for both Dravet and the LGS programs and have strengthened our global proprietary intellectual property position for FINTEPLA.

Looking ahead to the remainder of the year, we are preparing the NDA for FINTEPLA in Dravet syndrome for resubmission in September. In addition, our MAA application in Dravet syndrome remains under review in Europe. We remain on track with our LGS program and anticipate top line results in the first quarter of next year. And moreover, we are preparing to initiate a Phase II study of FINTEPLA in several severe childhood-onset epilepsy conditions later in the year. With that, I'll now turn the call over to Mike for his review of the financials. Mike?

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Michael P. Smith, Zogenix, Inc. - Executive VP, CFO, Treasurer & Secretary [4]

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Thanks, Steve, and good afternoon, everyone. Today, we issued a press release summarizing our business and financial results for the quarter ended June 30, 2019, which I'll now summarize. We recognized $1.1 million in revenue in the second quarter of 2019. This is a result of our March 2009 strategic distribution partnership for Japan with Nippon Shinyaku, for which we received upfront payments in the second quarter of $15.5 million for development activities related to FINTEPLA for the treatment of Dravet syndrome and LGS.

Total operating expenses for the second quarter were $41.9 million. R&D expense totaling $27.1 million for the quarter was the main component of our operating expenses, and we were predominantly driven by the ongoing global LGS Phase III program, a continued high level of participation of patients in our FINTEPLA open-label extension study and work related to our FINTEPLA NDA and MAA resubmissions.

SG&A expenses for the second quarter ended June 30, 2019 totaled $15.5 million, which reflects an 80% increase versus the second quarter of 2018. Our SG&A expense increase was driven by continued investment in preparations to prospectively launch FINTEPLA for the treatment for Dravet syndrome in the U.S. and in various countries in Europe in the coming years.

Net loss for the second quarter ended June 30, 2019 was $37.8 million or $0.89 per share. This compares with a net loss of $29 million or $0.83 per share in the second quarter ended June 30, 2018. In the first half of 2019, net loss was $73 million or a net loss of $1.72 per share compared with a net loss of $59.2 million or a net loss of $1.69 per share in the 6 months ended June 30 in the prior year.

We ended the second quarter with cash, cash equivalents and marketable securities totaling $463 million. With the continued strong balance sheet, we remain well positioned to execute on our strategic plan to bring FINTEPLA to market as a potential new treatment option for Dravet syndrome and LGS patients and their family and expand our pipeline through targeted business development, acquisition or licensing deals for rare disease therapeutic opportunities.

I'll now turn the call over to the operator to begin the Q&A session.

Operator, could you please provide the instructions?

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Questions and Answers

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Operator [1]

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[Operator's Instructions) Our first question comes from Difei Yang with Mizuho.

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Alexander Lim, Mizuho Americas Llc - MD & Head of Investment Banking [2]

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This is Alex on for Difei. I was wondering if you could comment a little bit on spending trends for the second half of '19 and into 2020 with the launch of FINTEPLA. How should we think about your cash burn going forward in the coming 6 to 12 months?

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [3]

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Alex, I'm going to hand that over to Mike who'll address it for you.

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Michael P. Smith, Zogenix, Inc. - Executive VP, CFO, Treasurer & Secretary [4]

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Yes. Sure. Thanks, Steve. Yes, so we would expect a similar cash operating expenses in the second half of the year as we have this year. They're slightly above where we were last year. Our R&D is relatively similar in the context of Dravet program concluding, but we do have a -- we have an ongoing open-label extension study that contributed to the R&D line as well as the LGS program, and we'll be starting a third program that's the -- in this year as we have to the first half. SG&A will go up slightly as we start to plan with respect to launching in the following year. And we haven't given any specific guidance on 2020 as yet. And so I think common sense says that it will be an increase over this year, but we're not guiding any specifics with respect to those costs.

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Alexander Lim, Mizuho Americas Llc - MD & Head of Investment Banking [5]

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Okay. Great. And then, if I may, just a final question. I'm wondering if you could give us an update on the ZX008 combo studies with CBD. Should we still expect to see some data from these studies by the end of the year?

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [6]

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Yes. Alex, as you know, we do have a study ongoing. It's an investigator-initiated study in a few centers in United States. Looking at the addition of ZX008 to patients who are taking various forms of CBD, these are investigator-initiated studies. So really, the publication of those data will be the responsibility of the physicians. There's a possibility that, that data may be available later in the year. But we will sort of follow up with that, but you might expect to see something later this year, if not, early next year.

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Operator [7]

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Our next question comes from Yatin Suneja with Guggenheim Partners.

Okay. Let's move on to Tim Lugo with William Blair.

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Lachlan Hanbury-Brown, William Blair & Company L.L.C., Research Division - Associate [8]

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This is Lachlan on for Tim. A couple from us. Following up on the prior question, how are you thinking about your combination use with Epidiolex? They just reported significant sales growth. They're obviously getting a good amount of use. I would like to hear your thoughts there? And then secondly, just have you given any thought to perhaps the size of this exploratory Phase II trial?

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [9]

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Yes. I -- it was difficult to hear you precisely, but let me see if I can decipher to my answer here. So we certainly expect that some of the use of FINTEPLA in the marketplace will be in combination with CBD. We also expect there to be patients who will be on our therapy and not on CBD. We have conducted the appropriate drug-drug interaction studies that will inform our future label in terms of how those products will be used together. Ashish, is there anything you want to say about commercial combination of those 2?

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Ashish M. Sagrolikar, Zogenix, Inc. - Executive VP & Chief Commercial Officer [10]

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At this point in time, it will be premature to say how physicians will use it. But I think what you have characterized makes absolute sense based on what we are hearing from the physicians. There is a need for multiple therapies. And each single therapy is not suitable for every patient. So we will see as the landscape evolves.

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [11]

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Thank you. And to refer to your second question, we haven't provided any information yet in terms of the size of that exploratory Phase II program. It's our intent to include several epilepsy syndromes into that study and of course, have adequate number of patients in order to be able to provide meaningful data. So we will provide more information on that protocol as we go forward this year.

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Operator [12]

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Our next question comes from Tazeen Ahmad with Bank of America.

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Sadia Rahman, BofA Merrill Lynch, Research Division - Research Analyst [13]

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This is Sadia Rahman on for Tazeen. My question has been regards to competitor development in Dravet and LGS. Can you comment on how you think FINTEPLA's mechanism and clinical data positions it within the competitive landscape? And specifically, how do you view the potential for gene therapy for Dravet treatment? Well, it's several years out, do you think mechanistically, it makes sense to try this group?

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [14]

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First, it's -- with respect to FINTEPLA, it does have its own unique matters of action in Dravet syndrome. It's a drug which has a different pharmacology to all the other antiepileptic drugs that are available today. And we are clearly thrilled to have been able to generate what we see as efficacy data that could create a new standard of care for the treatment of Dravet syndrome. So from that perspective, we think we have a very valuable drug and the drug that will be used widely by the Dravet syndrome community.

In terms of gene therapy, you're absolutely right. It's a long way off. It's an exciting opportunity, we believe. We do think that treating a high flow insufficiency with a gene therapy makes sense, and we'll continue to monitor area as we move forward.

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Sadia Rahman, BofA Merrill Lynch, Research Division - Research Analyst [15]

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Okay. And on your Phase III publication for Dravet, what new information could we look forward to there?

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [16]

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You mean our upcoming conferences or peer-reviewed publications?

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Sadia Rahman, BofA Merrill Lynch, Research Division - Research Analyst [17]

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Peer-reviewed publication.

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [18]

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Yes. We've got a number either in preparation on the peer review right now, which are really associated with our pivotal trials that we conducted with the Dravet program. So Study 1, Stage 1504 as well as open-label extension study. So those will be forthcoming and hopefully, over the next 6 to 12 months.

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Operator [19]

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Our next question comes from Danielle Brill with Piper Jaffray.

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Nirav Y. Shelat, Piper Jaffray Companies, Research Division - Research Analyst [20]

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This is Nirav on for Danielle Brill. I just had a couple. The first one was with Epidiolex on the market, and I think there's going to be a pretty short interval between FINTEPLA's launch in Dravet and its launch in LGS. So I was wondering how you were thinking about pricing?

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [21]

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Ashish, would you like to address that question?

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Ashish M. Sagrolikar, Zogenix, Inc. - Executive VP & Chief Commercial Officer [22]

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Definitely. In terms of the launch timing, I think it'll depend on our submission and as the agencies approved. So it will be premature to comment on that. And for pricing, it's too early to determine what the potential list price for FINTEPLA will be. We will be addressing potential considerations closer to the approval. However, as you know, it is -- FINTEPLA is not intended for the general epilepsy but for the Dravet, and we are looking at primarily the strength in Dravet's community and most importantly, ability of patients and families to have access to the therapy. Once we have our LGS data published and if it is positive, and when we receive approval, then that's the time we will be visiting how we will be looking at the price across indication.

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Nirav Y. Shelat, Piper Jaffray Companies, Research Division - Research Analyst [23]

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I I see. Okay. That's very helpful. The other question I had was from your interactions with experts. If we were to get FINTEPLA results in Phase III LGS trial to be similar to what Epidiolex has seen, what would you expect adoption to look like in competition with Epidiolex?

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [24]

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Yes, I don't think it's fair for us to speculate what our Phase III data are going to be until we read out Phase III results. So maybe that's a question we can actually address when we have those data.

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Operator [25]

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Our next question comes from Jason Butler with JMP Securities.

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Jason Nicholas Butler, JMP Securities LLC, Research Division - MD and Senior Research Analyst [26]

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I had 2. First, you mentioned that there are 380 Dravet patients across the Expanded Access Program in the 008. Can you just break out what the numbers are for each of those? And then secondly, on the newly allowed patent for covering elements to assure safe use, can you speak to how that patent could tie directly to language either in the product label or REMS program or both?

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [27]

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Yes. Thanks, Jason, for your questions. With respect to the breakout of Dravet patients in Expanded Access versus an open-label extension, it's approximately 100 in Expanded Access and the remainder in open label. I'm going to make the point here that, no, we have not -- we didn't start our EAP broadly. Deliberately, we started it in a small number of centers to get experience and confidence with the process. And now we're starting to expand the numbers of centers that can -- we can -- that could provide early access program. And that's really in demand what we're actually seeing by families out there. So we do expect as we move forward here prior to the product being approved, that the number of patients in Expanded Access will increase.

Second question, I've forgotten. And so appreciate if you could just give me a quick reminder.

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Jason Nicholas Butler, JMP Securities LLC, Research Division - MD and Senior Research Analyst [28]

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Sure. Just on the newly allowed patent for elements to assure safe use, just how that might tie in directly to the language in the label or the REMS program?

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [29]

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Very closely. Because it really does describe the distribution system that we've been putting in place that will be both reflected in the dosing administration in the label as well as elements of the future REMS program.

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Operator [30]

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(Operator Instructions) Our next question comes from David Sherman with LifeSci Capital.

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David A. Sherman, LifeSci Advisors, LLC - Director of Research [31]

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I I was just wondering, with regards to the Phase II exploratory study that you're talking about, do you envision standardizing background therapy? Or is there potentially going to be a need to do dose adjustments like you had done with stiripentol?

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [32]

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Sorry, David, could you just repeat that again for me and make sure I got it absolutely right?

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David A. Sherman, LifeSci Advisors, LLC - Director of Research [33]

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Sorry. I was just wondering, with the exploratory study, are you going to need to do any dose adjustments like you had done with the stiripentol trial?

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [34]

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Now we have that information. And clearly, that type of dose adjustment if patients are taking drugs with a drug-drug interaction -- a known drug-drug interaction with FINTEPLA, yes, that could -- that would be part of the protocol.

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Operator [35]

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Our next question comes from Yatin Suneja with Guggenheim Partners.

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Yatin Suneja, Guggenheim Securities, LLC, Research Division - MD & Senior Biotechnology Analyst [36]

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I apologize earlier, there was something wrong with my headset. Maybe 2 questions for me. First, could you maybe talk about your confidence in getting a priority review. Once you submit the file, what the timelines would be if you get the priority review? And then second, a little bit broader question. Could you maybe talk about how you are thinking about building the pipeline? Are there certain areas within the nearest psychiatry indications or disease area where you might be interested in the type of asset or transaction that you could do?

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [37]

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Okay. Thanks, Yatin. Glad we were able to connect. With respect to priority review, I've -- I'm not going to dive into the specifics of our interaction with the FDA at the meeting, but we feel very confident that the NDA resubmission will qualify for priority review, and that's really -- we factored that into our planning as we move forward here.

With respect to the pipeline, we are looking at a broad array of potential opportunities, but they're all characterized by being in the rare disorder space. Some of them are clearly heavily focused in neurology and even in the treatment of seizures, but there are other opportunities that are broader than that. So we are obviously looking intently at a variety of -- a number of things right now. We'd like to move a few of these closer to finish line. Clearly, we can't come to have any one of them until they've been signed, but we feel that there's a few opportunities ahead of us that we would like to move to closure. So in terms of the -- where they're at in development stage, we would prefer things that are either in preclinical or in the Phase II arena or up -- coming up to Phase III. I think in that particular environment, we would be able to uptick with -- the position of the asset, we'll be able to do appropriate development to increase on value as we move forward.

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Yatin Suneja, Guggenheim Securities, LLC, Research Division - MD & Senior Biotechnology Analyst [38]

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Got it. And then just one more quick question on the P&L side. I saw an uptick on R&D and G&A. Can you just maybe help us model it going forward for the second half? Should we anticipate the further uptick in R&D? I understand you might be building the commercial, so the G&A might go up, but just help us understand how we can model that.

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [39]

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Yes. I'll pass it over to Mike to address that question for you.

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Michael P. Smith, Zogenix, Inc. - Executive VP, CFO, Treasurer & Secretary [40]

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Yes. Yatin, SG&A will grow modestly in the second half versus the first half as it's getting closer to the launch. The R&D may increase slightly, not significantly. That is reflective of an increasing amount of patients that are being continually treated in -- with our -- in not just Dravet but with FINTEPLA for Dravet and LGS. So we do have our ongoing LGS study, and the Dravet study is concluded. But most of the patients -- predominantly most of the patients that ran through our Phase III programs are now enrolled in our open-label extension study. And so as patients are rolling into that study and continuing and not dropping out and then we're having LGS patients continue as well into its open-label extension study, we've got an increase versus where we were last year. We're just getting a lot more patient exposures. And that will continue until we're commercial in terms of those patients being on treatment. And we'll transition them to commercially available drug once we're approved.

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Operator [41]

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Next question comes from Marc Goodman with SVB Leerink.

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Roanna Clarissa H. Ruiz, SVB Leerink LLC, Research Division - Associate [42]

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This is Roanna Ruiz on the line for Marc. I just want to touch upon your distribution network. I think you mentioned it briefly in the prepared remarks. Could you give us any color around the number of locations? And do you -- did you build up any sort of buffer to meet up pent-up demand?

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [43]

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Thanks for your question. I can hand that over to Ashish to address it for you.

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Ashish M. Sagrolikar, Zogenix, Inc. - Executive VP & Chief Commercial Officer [44]

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Yes. Roanna, this is Ashish. And from a distribution network perspective, what we are looking at is our first indication to launch is going to be in Dravet syndrome. And given the monitoring that we will be needing to be doing for FINTEPLA, we are planning to have a limited distribution through a specialty pharmacy, where we can not only ensure that we follow the proper protocols but also have the monitoring systems in place so that it can be managed as we launch the product.

As far as your second concern in terms of the availability of the product, as we said in the prepared remark, the -- we've been able to do the validation for both our drug as well as the final product earlier, and those validation studies were very successful. We feel very confident that we'll be able to handle any demand that will come at the time of the launch.

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Roanna Clarissa H. Ruiz, SVB Leerink LLC, Research Division - Associate [45]

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Okay. Great. And just one quick follow-up. For your Expanded Access Program, just thinking ahead, when do you expect those patients to convert to paid drug after potential launch of FINTEPLA?

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Ashish M. Sagrolikar, Zogenix, Inc. - Executive VP & Chief Commercial Officer [46]

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Yes. That's a good question. I think it's going to be very difficult to speculate exactly how much time it will take, and it'll depend on individual patient's insurance and their situation. And as you have seen in some of the parallel therapies, it has taken anywhere between 6 to 9 months, depending on the condition of the patient and also place where they are in. So we will expect around the similar time frame. But our goal is to, at the time of the launch, be prepared to help transition these patients from early access program to the commercial therapy -- commercial product.

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Operator [47]

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I would like to turn the floor over to Steve for closing comments.

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President & Director [48]

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Oh, thank you, operator. We are focused on resubmitting our FINTEPLA NDA in Dravet syndrome in September as we've just discussed. And obviously, we're actively preparing for an expected U.S. commercial launch next year. We're also very excited about the expected availability of the top line Phase III data from our FINTEPLA/LGS program in the first quarter of 2020. So we look forward to providing you with further updates throughout the second half of this year. With that, I thank you for joining us today. Enjoy the rest of your day. Goodbye.

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Operator [49]

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This concludes today's conference. Thank you for your participation.