Zogenix, Inc. (ZGNX)

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ZGNXhttp://www.nasdaq.com/symbol/zgnxHealth Care2010Major Pharmaceuticals

Latest Zogenix, Inc. (ZGNX) company news

Harry Boxer’s five stocks to watch today

Stocks across technology, biotech and digital advertising round out our top charts to watch today.

Amicus Therapeutics Inc. FOLD, +5.76% rose 28 cents to close at $13.96 on 3.7 million shares traded Tuesday. Price had popped out of a strong base formation on July 11 with positive FDA news. Now a bull wedge has been created that just may be the fuel needed for this stock to extend even farther over the next several days. Next targets: $15 and $17. Short interest of 11.7 times its average volume could fuel the move as short-sellers cover on a rally.

Kopin Corp. KOPN, +0.22% had a big day with the announcement of its new high-brightness LCD product line. The wearables-technology stock climbed 5.6% and closed at $4.52 on heavy volume of 2 million shares traded. That is one of the highest volume days the stock has seen in the past few years. Its movement in the past two sessions is significant, given the increasing volume and its breakout from a key lateral resistance level. Look for next targets at $4.75 and possibly $5.25 with continued momentum in the near term. Short interest of 10.4 times its average volume could fuel the move as short-sellers cover on a rally.

The Trade Desk Inc. TTD, -0.45% gained $1.63, closing at $61.72, on 1.2 million shares traded Tuesday. When price moved up past its lateral resistance level on Sept. 11, it next formed a bull flag. After an IPO just about a year ago, the digital-advertising stock has been on the rise, gaining 27% just since Aug. 17 on news of strong earnings and its outlook for the rest of 2017. If the stock closes above $63, it could well move to $70 and perhaps $75.

Universal Display Corp. OLED, -2.93% hit an all-time high of $145.30 and jumped $5.52, or 4%, on Tuesday, closing at $142.20 on unusually heavy volume of 1.6 million shares traded. The move came with news of a very positive outlook from a Goldman Sachs analyst, who forecasted that the stock may reach as high as $254 given its potentially game-changing display technology. This stock has gained 27% in the past three weeks. With momentum in its current rising channel, price could reach our next target of $175-$180.

Zogenix Inc. ZGNX, -4.04% rose 30 cents to close at $14.55 on very heavy volume of 1.1 million shares traded Tuesday. The higher-volume level comes as the market anticipates the company’s clinical-trial results announcement at the end of the month. If price can break above the bull flag it is forming near the $15.10 resistance level, it could start to run. A double-bottom formation around $13.60 may signal that it has run out of energy. Short interest of 11.8 times its average volume could fuel a move up.

See Harry’s video-chart analysis on these stocks.

The writer has no holdings in any of the securities mentioned.

Harry Boxer is founder of TheTechTrader.com, a live trading room featuring his stock picks, technical market analysis, and live chart presentations.

Are Options Traders Betting on a Big Move in Zogenix (ZGNX) Stock?

Investors in Zogenix, Inc. ZGNX need to pay close attention to the stock based on moves in the options market lately. That is because the Sep 15, 2017 $20 Call had some of the highest implied volatility of all equity options today.

What is Implied Volatility?

Implied volatility shows how much movement the market is expecting in the future. Options with high levels of implied volatility suggest that investors in the underlying stocks are expecting a big move in one direction or the other. It could also mean there is an event coming up soon that may cause a big rally or a huge sell off. However, implied volatility is only one piece of the puzzle when putting together an options trading strategy.

What do the Analysts Think?

Clearly, options traders are pricing in a big move for Zogenix shares, but what is the fundamental picture for the company? Currently, Zogenix is a Zacks Rank #3 (Hold) in the Medical - Drugs industry that ranks in the Top 43% of our Zacks Industry Rank. Over the last 60 days, no analyst has increased the earnings estimates for the current quarter, while one analyst has dropped its estimates. The net effect has taken our Zacks Consensus Estimate for the current quarter from a loss of 92 cents per share to a loss of 97 cents in that period.

Given the way analysts feel about Zogenix right now, this huge implied volatility could mean there’s a trade developing. Often times, options traders look for options with high levels of implied volatility to sell premium. This is a strategy many seasoned traders use because it captures decay. At expiration, the hope for these traders is that the underlying stock does not move as much as originally expected.

Looking to Trade Options?

Each week, our very own Dave Bartosiak gives his top options trades. Check out his recent live analysis and options trade for the NFLX earnings report completely free. See it here: Bartosiak: Trading Netflix's (NFLX) Earnings with Options or check out the embedded video below for more details:
 

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Zogenix, Inc. (ZGNX) Jumps: Stock Rises 5.2%

Zogenix, Inc. ZGNX was a big mover last session, as the company saw its shares rise over 5% on the day. The move came on solid volume too with far more shares changing hands than in a normal session. This continues the recent uptrend of the company- as the company is now up 52.6% in the past one-month time frame.

The company has seen no estimate revisions over the past one month, and the Zacks Consensus Estimate for the current quarter has also remained unchanged. The recent price action is encouraging though, so make sure to keep a close watch on this firm in the near future. 

Zogenixcurrently has a Zacks Rank #3 (Hold) while its Earnings ESP is 0.00%.

Zogenix, Inc. Price and Consensus

Zogenix, Inc. Price and Consensus | Zogenix, Inc. Quote

A better ranked stock in the Medical - Drugs industryis MEI Pharma, Inc..MEIP which carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Is ZGNX going up? Or down? Predict to see what others think: Up or Down

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3 Biotech Stocks That Could Soar in September

Winter seems to always be coming in Game of Thrones, but here in the real world, autumn is on the way. While the leaves will start falling in September, some biotech stocks could be set to soar.

Quite a few biotechs have important catalysts coming up in the next month. Three biotechs that could especially benefit from big news on the way are Alnylam Pharmaceuticals (NASDAQ:ALNY), PTC Therapeutics (NASDAQ:PTCT), and Zogenix (NASDAQ:ZGNX). Here's what they have in store in September.

Charts in front of hundred dollar bill

Image source: Getty Images.

Alnylam Pharmaceuticals

Alnylam stock has soared in 2017, up close to 130% year to date. The biotech has reported positive results from a phase 2 study of experimental hemophilia drug fitusiran. Alnylam also received breakthrough-therapy designation for givosiran in treating acute hepatic porphyrias (a rare nervous system disease) and an influx of cash from partner Sanofi

But Alnylam should have the biggest news of all coming up in the next few weeks -- potentially even earlier than September. The biotech expects to announce top-line data from its late-stage study of patisiran in treating patients with hereditary ATTR (hATTR) amyloidosis. If those results are positive, Alnylam intends to file for regulatory approval by the end of 2017. 

There is a risk, however, that those results won't be as good as desired. Rival Ionis Pharmaceuticals reported concerning side effects in May from its late-stage study of inotersen, a potential competitor to patisiran. But if Alnylam reports solid efficacy without similar serious side effects, expect its stock to take off even more than it already has so far in 2017.

PTC Therapeutics

PTC Therapeutics is another biotech stock that's performed well in 2017, with shares up more than 70% year to date. Much of those gains have come in anticipation of an FDA advisory committee meeting scheduled for Sept. 28. The committee will review PTC's regulatory filing for Translarna in treating nonsense Duchenne muscular dystrophy (nmDMD). 

The results from this committee meeting should be quite interesting. PTC Therapeutics tried to file for approval of Translarna last year, but the FDA wouldn't accept the company's submission. The company decided to move forward anyway, filing under protest. 

Sarepta Therapeutics (NASDAQ:SRPT) already scored a controversial approval for its DMD drug, Exondys 51. With Sarepta's launch of Exondys 51 seemingly going pretty well, PTC Therapeutics wants its chance, too. A positive recommendation by the FDA advisory committee would be huge in the biotech's getting that chance. 

Zogenix

Zogenix hasn't soared like Alnylam and PTC Therapeutics have so far this year. In fact, the stock is barely above its price at the start of 2017. That could soon change, though.

The biotech expects to announce results from its late-stage study of ZX008 in treating Dravet syndrome by the end of September. Good news from that study should bode well for another pivotal late-stage study of the drug for the same indication that's close to completing enrollment. 

One company that will probably watch what happens with Zogenix intensely is GW Pharmaceuticals (NASDAQ:GWPH). GW Pharma should complete its regulatory filing for Epidiolex in October for treating Dravet syndrome and Lennox-Gastaut syndrome (LGS). Good news for ZX008 could mean that Zogenix and GW Pharma will compete directly against each other in the next few years. 

Sinking in September?

Investors should be aware, though, that each of these stocks could just as easily sink in September instead of soar. Clinical results and regulatory decisions aren't always positive. 

PTC Therapeutics probably faces the greatest risk. Filing under protest with the FDA isn't a high-probability move. Alnylam could also experience a similar fate as Ionis with its late-stage results. And even if Zogenix gets good news from its first late-stage study for ZX008, there's still another one to go before possibly filing for approval.

The possibility for huge rewards typically comes joined at the hip with the possibility of huge failure. Both exist for Alnylam, PTC, and Zogenix. 

Keith Speights has no position in any of the stocks mentioned. The Motley Fool owns shares of and recommends Alnylam Pharmaceuticals and Ionis Pharmaceuticals. The Motley Fool has a disclosure policy.

Edited Transcript of ZGNX earnings conference call or presentation 8-Aug-17 8:30pm GMT

Q2 2017 Zogenix Inc Earnings Call

SAN DIEGO Aug 13, 2017 (Thomson StreetEvents) -- Edited Transcript of Zogenix Inc earnings conference call or presentation Tuesday, August 8, 2017 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Brian Ritchie

LifeSci Advisors, LLC - MD

* Michael P. Smith

Zogenix, Inc. - CFO, EVP, Treasurer and Secretary

* Stephen J. Farr

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

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Conference Call Participants

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* Ashiq Mubarack

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Presentation

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Operator [1]

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Good day, and welcome to the Zogenix, Inc. Second Quarter 2017 Financial Results Conference Call. Today's conference is being recorded.

At this time, I would like to turn the conference over to Brian Ritchie, LifeSci Advisors. Please go ahead, sir.

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

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Thank you, operative, 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, Mike Smith. This afternoon, Zogenix issued a news release announcing financial results and providing a business update for the second quarter and 6 months ended June 30, 2017.

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's 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 8, 2017. 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 and Director [3]

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Thank you, Brian, and good afternoon to everyone who is joining us on today's call. I'm very pleased to report that we're on track to announce top line safety and efficacy results from our first Phase III trial in Dravet Syndrome late in this quarter. As a reminder, Study I, which was fully enrolled in April, is a 3-arm double-blind fixed-dose placebo-controlled trial designed to enroll approximately 40 subjects per treatment group and includes patients from sites in the United States, Canada, Europe and Australia. A total of 119 subjects have been randomized into 1- or 2-dose groups of ZX008, 0.2 and 0.8 milligrams per kilogram per day or placebo. After a 6-week baseline period, randomized subjects are titrated to their target dose over 2 weeks and then held to that fixed dose for 12 weeks of maintenance treatment.

The primary objective of the study is to demonstrate that ZX008 at the high dose is superior to placebo in controlling seizures based on the change in the frequency of convulsive seizures between baseline and the combined titration and maintenance periods. The percent of patients who achieved equal or greater than 50% reduction in convulsive seizures, a measurement of the longest seizure-free interval, are key secondary endpoints. The same 3 analyses are all key secondary endpoints for a comparison of the lower dose versus placebo. Other secondary endpoints include assessments of clinical global impression and quality of life. We are pleased to be close the availability of top line results from our first pivotal trial of low-dose fenfluramine and controlling seizures in children and young adults with Dravet syndrome. This will be a significant milestone for our company.

The second planned pivotal trial in our Phase III Dravet syndrome program is Study 1504, a double-blind randomized 2-arm Phase III trial in which all subjects will be taking stiripentol as part of their baseline standard of care. As a reminder because study 1504 permits stiripentol, it draws from patients who are excluded from study 1, which is beneficial for both enrollments of the study and expanding the scope of clinical experience of ZX008 in Dravet syndrome. We initiated the safety and efficacy portion of study 1504 in early February and the trial is now approximately 2/3 enrolled. During the second quarter, sites in the U.K. and Spain joined the study, adding to those in France, the Netherlands, Germany, the U.S. and Canada who are actively enrolling subjects. All 24 of the planned sites are now up and running. We are continuing to drive recruitment efforts during the summer months to reach a target of last patient enrolled into the study during the current quarter.

Across the entire Phase III program in Dravet syndrome, over 300 patients have been screened. All patients, currently more than 120, who have completed one of the ongoing randomized control trials, have elected to enter Study 1503, the open-label long-term extension study. The vast majority of these patients, around 97%, remain in the trial today on ZX008 treatment. Moreover, the first Dravet syndrome child in our Phase III program has now entered their second year of open-label treatment in Study 1503. Safety, including cardiac safety, is being evaluated in the clinical program by an independent data safety monitoring committee. Their most recent formal meeting occurred in July, the outcome of which was a recommendation to continue the trials without modification. We believe this outcome is a positive indicator regarding the safety profile of ZX008 as administered in the studies to pediatric patients.

Turning now to our second current target indication for ZX008, we were pleased to recently announce the receipt of orphan drug designation in Lennox Gastaut Syndrome, or LGS, in the U.S. As you know, the FDA also previously accepted our IND submission, allowing us to proceed into a Phase III trial. We intend to initiate the study in the fourth quarter of this year, following our first Phase III results in Dravet syndrome, and have been engaged in a number of activity to ensure a fast and successful start for this global Phase III trial. Study start up is underway with a participation of 17 U.S. sites that are being fast tracked for patient enrollment. Feasibility for additional sites is also underway in the U.S. and other countries. Based on our efforts to date, we continue to expect that the first patients will enter the planned Phase III LGS trial in the fourth quarter of this year.

Moving into the LGS indication for ZX008 presents a significant opportunity for Zogenix as there are an estimated 30,000 to 50,000 LGS patients in the U.S. and Europe. LGS is another severe catastrophic childhood-onset epilepsy with a high unmet need in which approximately 80% of patients remain uncontrolled despite currently available treatments. A broad spectrum of anti-epileptic drugs or AEDs are commonly used, including valproate, clobazam, levetiracetam, lamotrigine, topiramate and rufinamide. Nearly all who patients are being treated with multiple AEDs, generally 3 or 4, and treatment is often continually modified due to poor efficacy and its horrible side effects. Unfortunately, the vast majority of LGS patients would experience debilitating features throughout their entire life. And based on the unique profile of ZX008, we believe it has significant potential as a safe and effective treatment for LGS.

Before I turn the call over to our Chief Financial Officer, Mike Smith, let me review the potential -- potentially value-enhancing milestones we expect for ZX008 over the next 12 months. Top line data from Phase III Study 1 in Dravet syndrome, top line data from Phase III Study 1504 in Dravet syndrome, filing for regulatory approval for -- in the U.S. and Europe for Dravet syndrome and finally, initiating a global Phase III study in LGS.

And 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. - CFO, EVP, Treasurer and Secretary [4]

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Thank you, Steve. Before jumping into the financials, I'd like to briefly touch on the recently announced termination of our Relday license agreement with DURECT Corporation. In September 2015, we announced positive results from a Phase Ib study for Relday, a proprietary long-acting injectable formulation of risperidone in schizophrenia patients. At that time, we stated our intention to advance the program further by securing a global strategic development and commercialization partner so we could focus our internal efforts on ZX008 for Dravet syndrome. Despite multiple expressions of interest and due diligence engagement surrounding the asset, ultimately, we are unable to conclude a global licensing partnership for the program. Accordingly, we have now returned full development and commercial rights related to Relday to DURECT, which allows us to focus 100% of our efforts on building a product portfolio focused on orphan CNS disorders, beginning with ZX008 in Dravet. Consistent with this strategic focus, in April, we completed the fulfillment of all remaining orders of SUMAVEL DosePro and now have no further obligations to supply Endo with additional product.

With that, here are our financial results for the quarter. Total revenue for the second quarter ended June 30, 2017, was $7.1 million, this consisted entirely of contract manufacturing revenue for SUMAVEL DosePro. This compared to total revenue of $2.1 million in the second quarter of 2016, which also consisted nearly entirely of contract manufacturing revenue. The $5 million increase in revenue in the second quarter of this year was due to the delivery of more SUMAVEL DosePro units to Endo.

R&D expenses for the second quarter ended June 30, 2017, totaled $14.9 million, and that's up from $10.4 million in the second quarter of the prior year as we continue to enroll patients into and expand the scope of our Phase III studies for ZX008 in both U.S. and Europe. Selling, general and administrative expenses for the second quarter ended June 30, 2017, totaled $5.5 million, and that is down from $6.8 million in the second quarter ended June in the year prior.

Net loss from continuing operations for the second quarter in 2017 was $22.5 million compared to $18.2 million in the second quarter of the prior year. Net loss from discontinued operations for both the second quarter ended June 30, 2017, and June 30, 2016, was $0.6 million. We reported a total net loss for the second quarter ended June 30, 2017, of $23 million or $0.93 per share. This compares with a net loss of $18.8 million or $0.76 per share in the second quarter for 1 year ago.

Turning to the 6 month period ended June 30 in '17 and 2016, total revenue for the 6 months ended June 30, 2017, was $9.8 million, comprised, again, almost entirely of contract manufacturing revenue. This compared with total revenue of $11.3 million in the same 6-month period of 2016. The decrease was due to a reduction in the number of SUMAVEL DosePro units that we delivered to Endo.

Research and development expenses for the first half of 2017 totaled $28.2 million, and this is up from $18.4 million in the first half of the year prior, and again, reflects the continued enrollment and expansion of our Phase III clinical trials for ZX008 in Dravet syndrome. SG&A expenses for the 6-month ended June 30, 2017, totaled $12.1 million, and this compares favorably to $13 million in the same 6-month period of the prior year.

Net loss from continuing operations for 6 months ended June this year was $43.6 million compared with $28.5 million for the 6 months ended June 30, 2016. Net loss from discontinuing operations for the 6 months ended June 30, 2017, was $0.7 million compared to $0.8 million for the same 6-month period of the prior year.

We reported total net loss for the 6 months ended June 30, 2017, of $44.3 million or $1.79 per share. And this compares with an net loss of $29.2 million or $1.18 per share in the same 6-month period of the prior year.

We ended the quarter with $65.8 million in cash and cash equivalents, and this compares to $91.6 million that we had at the start of this year. Our ZX008 Phase III program for Dravet remains a predominant operational focus for the company, and as Steve noted, Study 1 remains on track for its first top line readout in the program for the third quarter of this year.

Our next Phase III program, investigating the potential of ZX008 as a treatment in LGS, remains on track to initiate following our Study 1 readout.

As these key milestones approach, we are pleased to remain in strong financial position with over $65 million in cash and cash equivalents. We currently estimate that we have enough cash to fund our operations into the first half of 2018.

I'll now turn the call over to the operator to begin the Q&A session. Operator, would you please provide the instructions?

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our next question will come from Tim Lugo of William Blair & Company.

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Ashiq Mubarack, [2]

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This is Ashiq Mubarack on for Tim. So I was just wondering if you could kind of remind us about what you might define as a successful data for Study 1. Have your expectations kind of shifted? Or I mean, can you share maybe some of your thoughts there if they have changed at all?

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

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Yes, thanks to your question. Obviously, our definition of a successful study is meeting the primary endpoints of the trial and also the key secondaries as well. You will recall that we have actually powered our trial, we think, rather conservatively to assess a 40-point difference between active and placebo and -- just based upon what we've seen in open label with this drug and also recognizing the placebo response in this patient population has been recorded has been quite low over a number of trials. So we have powered it conservatively 90% power to detect a 40-point difference.

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Ashiq Mubarack, [4]

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Okay, great. And would you be able to tell us about any regulatory communications you've had recently or are there any plans to speak with the FDA anytime soon?

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President and Director [5]

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Really, there's been no -- other than routine updates, there's been really no formal interaction with the FDA. We obviously, we're busy doing our Phase III program, and we look forward to getting the results from that Phase III program at the end of this quarter.

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Ashiq Mubarack, [6]

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Okay, that makes sense. And then just last one. Can you talk a little bit about your expectations for SG&A maybe particularly on hiring and any thoughts there for the remainder of the year?

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President and Director [7]

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I'll hand that over to Mike.

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Michael P. Smith, Zogenix, Inc. - CFO, EVP, Treasurer and Secretary [8]

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Yes. Yes, so we, as you well might likely know, that we retained full global rights to the product and so we've got a lot of flexibility with respect to how we introduce the product should we be successful in Phase III and garnering approval. We expect that the overall scope of SG&A will be similar to that for a orphan company, if we decide to commercialize and so there's a lot of leverage that we can gain from having a product that basically is in a small patient population, roughly 5,000 treatable patients in the U.S. for this first indication. So we don't expect to be on the high level at all for SG&A but more standard in terms of an orphan company with 1 product.

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Operator [9]

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(Operator Instructions) And with no further questions at this time, I'd like to turn the call back over to Dr. Farr, President and CEO.

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Stephen J. Farr, Zogenix, Inc. - Co-Founder, CEO, President and Director [10]

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Thank you, operator. We are obviously looking forward to the availability of top line data from Study 1 later in this quarter. We continue to believe that ZX008 has potential to transform the lives of children and their families with Dravet syndrome. Our Phase III program remains on track and we're also preparing to initiate a Phase III program in LGS, once, of course, we have the first pivotal trial results from Dravet syndrome. Importantly, our clinical development activity continues to be supported by a strong balance sheet, and we look forward to keeping everyone updated on our progress in the second half of 2017. Thank you for joining us today, enjoy the rest of your day.

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Operator [11]

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And ladies and gentleman, this does conclude today's conference. We thank you for your participation. You may now disconnect.

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