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Zogenix's (ZGNX) Stephen Farr on Q2 2016 Results - Earnings Call Transcript

Zogenix, Inc. (NASDAQ:ZGNX)

Q2 2016 Earnings Conference Call

August 09, 2016, 04:30 PM ET

Executives

Brian Ritchie - IR LifeSci Advisors

Stephen Farr - President and CEO

Ann Rhoads - CFO

Analysts

Andrew Finkelstein - Stifel

Difei Yang - Brean Capital

Rohit Vanjani - Oppenheimer

Raju Prasad - William Blair

Operator

Good day and welcome to the Zogenix Incorporated Second Quarter 2016 Financial Results Conference Call. Today’s call is being recorded.

And at this time, I would like to turn the call over to Brian Ritchie of LifeSci Advisors. Please go ahead.

Brian Ritchie

Thank you. 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, Ann Rhoads.

This afternoon, Zogenix issued a news release announcing financial results and providing a business update for the second quarter ended June 30, 2016.

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’s 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 09, 2016. 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.

Stephen Farr

Thank you, Brian, and good afternoon to everyone who is joining us live on today’s call.

Second quarter was another busy one for Zogenix, importantly our Phase 3 program evaluating ZX008 an adjunctive therapy for children associated with Dravet syndrome is progressing well both in the United States as well as in Europe.

During the second quarter, we initiated our multinational study, Study 1502 with sites in Western Europe and in Australia. We're now actively enrolling patients at sites for our North American study, Study 1501 as well as in Study 1502.

For Study 1501 over half of the planned 24 sites are now able to enroll patients and we expect the majority of the other sites will be active by September, pending final IRB approvals.

Study 1502, which is planned for total of 30 sites is now open for enrolling patients at 13 sites over four countries. We expect to have the vast majority of the remaining participating sites up and running in the August, September time period.

We are truly gratified by the enthusiasm we're seeing for our Phase 3 program from some of the leading U.S. and European academic centers who care for large number of Dravet patients, which we view as validation of potential of ZX008 to make a significant difference in the lives of Dravet patients and their families.

For example the principle investigator study 1501, Dr. Joseph Sullivan from the Paediatric Epilepsy centre UCSF, running of children's' hospital enrolled his allocated member of subjects within the first week of his site being up and running.

Most importantly though based on the current figures of Study 1501 and 1502 we continue to expect that the U.S. and European submissions for market organizations for ZX008 will occur in 2017. For us this is the key timeline on which to focus.

Let me move briefly on to Study 1504, which is a two-part study to investigate the effect of adjunctive ZX008 for Dravet patients who are not completely controlled on a stiripentol regimen. The first site was initiated recently for cohort 1, this is the PK portion of the trial and we expect that Study 1504 will be getting enrolling patients too.

Next I'd like to discuss two important upcoming catalysts for us. At the 12th European Congress on Epileptology which takes place September 11 through the 15 in Prague, Czech Republic, there will be an update on efficacy and cardiovascular safety in a new cohort of Dravet syndrome patients participate in an ongoing prospective open-label trial of ZX008 or low-dose fenfluramine that's being conducted in Belgium.

As you know the open-label data generate the data shown unprecedented levels of efficacy with respect to seizure reductions. These results further enhance our confidence in a potential for a positive outcome for our ongoing Phase 3 program.

There will also be presentations on our work on the burden of illness in Dravet syndrome as well as efforts towards a composite clinical end point that refract patient and caregiver relevant outcome measured through semi qualitative research and on the global impact to Dravet syndrome this were being led by expert Dr. Rima Nabbout in Paris.

In addition, a poster will be presented by Dr. Mark Jensen of the University of Washington and Seattle reporting new data from an expert panel on caregiver Dravet syndrome. This work by funded by Zogenix under an investigator initiated study group.

And lastly at the same conference, we will be sponsoring a symposium entitled, Understanding the Biology and treating early onset of epileptic enteropathy in the year 2020 and this will be with international experts speakers including Dr. Joe Sullivan from the U.S. Lieven Lagae from Belgium, Rima Nabbout from France, Ben Whalley from the United Kingdom and [Tim] from Germany.

Another important upcoming milestone for us the availability of topline data from the Phase 2 investigator initiated study obviously ZX008 in Lennox Gastaut syndrome, a drug-resistant, childhood onset epilepsy syndrome.

This study is currently being conducted by Lieven Lagae, MD, PhD, who is a professor at the University of Leuven in Belgium. Professor Lagae intensely submit a late breaking abstract full presentation of the topline data at the 2016 American Epilepsy Society Meeting which will take place December 2 through the 6 in Houston, Texas.

I am pleased to report that this study is enrolling well and there are number of patients currently on drug.

Before I conclude my comments on the ZX008 I would like to talk a little bit about the significant presence we had of the 2016 Dravet syndrome foundation annual meeting, which took place in June in Coral Gables, Florida. This unique meeting pulled together multiple stakeholders in the Dravet syndrome community, panelist, caregivers, clinicians, researchers and pharmaceutical industry professionals.

For Zogenix the conference provide us with an important opportunity to discuss our Phase 3 clinical program for ZX008 to a significant number of parents and clinical investigators. Again we were quite pleased with the high level of interest in ZX008 from each of the stakeholders groups in attendants.

Now let me turn to Ralday, our proprietary once-monthly subcutaneous investigational formulation of risperidone for the treatment of schizophrenia. Our process aimed at...


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