Gregory Gin - IR Brian Leuthner - President and CEO Andrew Saik - CFO.

Martin Auster - Credit Suisse Jason Butler - JMP Securities LLC Benjamin Burnett - Leerink Partners LLC Unidentified Analyst - Maxim.

Good day, ladies and gentlemen. Welcome to the Edge Therapeutics Fourth Quarter and Full Year 2017 Conference Call. At this time all participants are in a listen-only mode. After management's prepared remarks there would be a question-and-answer session and instructions will follow at that time. As a reminder, this conference call is being recorded.

I'll now introduce your host for today's conference, Greg Gin of Edge Therapeutics. Please go ahead..

Thank you, Bruce. Good morning everyone and welcome to today's conference call to discuss our fourth quarter and full year 2017 financial results and corporate highlights. Let me remind you that today's conference call may contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

To the extent that any statements made on this call contain information that is not historical, these statements are forward-looking statements and are not guarantees of future performance and involve risks and uncertainties, including those noted in this morning's press release and Edge's filings with the SEC.

Investors, potential investors, and other listeners are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements. Actual results may differ materially from those projected in the forward-looking statements.

Edge specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law. One more comment, following today's call and Q&A session the company will be in a quiet period until we announce the outcome from the interim analysis of our Phase 3 NEWTON 2 study which is expected by the end of April.

While we acknowledge that some of you may have questions in the coming weeks we appreciate your understanding and look forward to reengaging with everyone once we have communicated the outcome of the interim analysis. And with that, I will now turn the call over to Brian..

Thanks Greg and good morning everyone and thank you for joining us today. Since 2009 Edge has been focused on developing EG-1962 in order to help advance the standard of care for patients with aneurysmal subarachnoid hemorrhage or aSAH.

We believe that EG-1962 has the potential to improve patient outcomes compared to the current standard of care oral nimodipine by delivering 100 to a 1000 times of concentration of nimodipine directly into the cerebral spinal fluid in the brain with sustained delivery over 21 days.

Results from our Phase 2 NEWTON study and non-clinical studies supported our hypothesis and provides a rationale for our Phase 3 NEWTON 2 study EG-1962. We believe that oral nimodipine while showing to be affective at improving patient outcomes following aSAH provides limited efficacy due to sub optimal drug exposure in the brain.

In fact it is virtually impossible to get concentrations of nimodipine that are similar to those provided by EG-1962 into the brain with oral nimodipine without causing dose limiting and potentially life threatening hypotension.

In 2007 Edge achieved meaningful progress towards our goal of addressing the unmet needs in patients with aneurysmal subarachnoid hemorrhage. Our Phase 3 NEWTON 2 study is proceeding on track to the interim analysis after we completed the pre-planned utility analysis in December.

We also began preparing for potential commercialization of EG-1962, in fact a key step in establishing the supply of EG-1962 for potential commercialization with securing a commercial supply agreement with an external manufacturer for EG-1962.

In addition as part of our pre-commercial planning we continued to gain a better understanding regarding the health economics and the tremendous economic burden of aSAH patients. We expect to report the top line results of our Phase 3 NEWTON 2 study in late 2018.

By the end of April we anticipate reporting the outcomes from the formal interim analysis for efficacy upon the completion of the 90 day follow-up visit of the first 210 patients in NEWTON 2. Now during recent investor meetings we received a number of questions regarding the various scenarios around the interim analysis.

The DMC or Data Monitoring Committee can recommend one of the following possible outcomes from this analysis. The DMC may recommend proceeding to full enrolment of 374 patients. This is the outcome that we planned for.

In this case the study needs to achieve a 10% to 15% absolute difference in the proportion of favorable outcomes of EG-1962 patients versus oral nimodipine patients at 374 patients enrolled. As I previously stated we expect top line results from the full NEWTON 2 study in late 2018.

A key point here is that we've spoken to hundreds of our target customers, the neurosurgeons and neurointensivist and to them a clinically meaningful benefit is around a 10% to 15% absolute difference in outcome. We believe that the sample sizes of our NEWTON 2 study is designed to detect that effect.

Or the DMC may recommend stopping the study with 210 patients based on overwhelming efficacy. Remember that they are the considerably higher threshold to stop the study for efficacy at the interim time point than to achieve success at full enrolment.

For the study to be stopped early, the results from the interim analysis would need to be greater than about 20% absolute difference in the proportion of favorable outcomes among EG-1962 treated patients versus patients receiving oral nimodipine.

Now in this case we would go meet with the FDA and the other health authorities to discuss submission of a market application following the interim analysis.

Another scenario, if the study nearly missed the threshold for stopping at the interim is that the DMC may recommend stopping enrolment and waiting for the efficacy data from the additional patients randomized after the 210th patient up to the time of the interim analysis. Now we often get asked is there a form of futility analysis.

So there is no form of futility analysis built into the interim analysis. However the DMC as you know may recommend amending or terminating the study for safety concerns or based on benefit risk assessment that does not justify additional subject enrolment.

So now for some of you that may be new to the Edge story I'd like to briefly review some of the key components of the NEWTON 2 study. It seems conducted at about 75 centers in North America, Europe, Israel, and Asia.

The study design was informed by three key factors; our encouraging Phase 2 study results, input from thought leaders in neurosurgery and neuro critical care, and discussions with regulators. We've designed the Phase 3 study to mirror the key design elements of the Phase 2 NEWTON study.

That is we've used the same patient populations as WFNS 2 through 4 with an extra ventricular drain or EVD, the same comparator EG-1962 versus standard of care oral nimodipine and the same assessment for efficacy, the GOSE with favorable outcomes defined by score of 6 through 8.

Now we expect the results of the NEWTON 2 study if positive to form the basis for our marketing application to the U.S. FDA for the approval of EG-1962 for the treatment of aneurysmal subarachnoid hemorrhage. If positive we also plan to pursue regulatory submissions in other geographies.

So from a manufacturing and supply chain perspective we believe we're in a solid position as we prepare for commercialization having secured that commercial supply agreement with the external manufacturer of EG-1962 for initial product launch and thereafter.

Now turning to other pre-commercial activities for EG-1962 let me briefly touch on some key findings from independent research on commercial payers views of EG-1962. The research finding suggest that EG-1962 pricing flexibility and access would be supported by payers based on a 10% to 15% improvement versus standard of care.

And as I mentioned that is the primary endpoint of the NEWTON 2 study. So we think a 10% to 15% absolute difference may support premium pricing based on payer research. Now most payer respondents were emphatic. The EG-1962 management should be left to the hospitals. So with that I'll turn the call over to Andrew do discuss our financial results..

Thank you Brian. As of December 31, 2017 cash and cash equivalents and markets securities were $88.1 million compared to $106.4 million as of December 31, 2016. Net cash used in operating activities were $40.7 million for the year.

Research and development expenses for the fourth quarter were $10.8 million inclusive of approximately $0.6 million of non-cash stock compensation expenses. For the full year 2017 R&D expenses were $34.3 million including $2.7 million of non-cash stock compensation expense.

R&D expenses during 2017 reflected increased spending primarily due to an increase in external expenses related to EG-1962 clinical development, EG-1964 formulation development, and personnel related costs for the NEWTON 2 study.

General and administrative expenses were $5.3 million for the fourth quarter including approximately $0.9 million of noncash compensation expense. For all of 2017 G&A expenses were $17.7 million including $3.5 million of noncash compensation expense.

G&A spending during 2017 reflected increases in personnel related costs, Investor Relation costs, stock based compensation expenses, and legal and professional fees. We reported a net loss of $13.9 million in the fourth quarter and $50.9 million for the full year 2017. As of February 22, 2018 we had 30.9 million shares outstanding.

As we look ahead our expected cash burn is roughly $50 million to $60 million dollars in 2018. Based on our current plans we expect our cash and cash equivalents to be sufficient to fund our operations through the full data readout from our NEWTON 2 study which is anticipated to incur in late 2018 with a cash cushion left over afterwards.

And now I'll turn it back over to Brian..

Thanks Andrew. So in closing 2018 will be a pivotal year for Edge.

Looking ahead we believe that we are operationally and financially well positioned to execute on our corporate growth strategy in particular continuing to advance EG-1962 through achievement of key additional clinical milestones including the NEWTON 2 interim analysis by the end of April, and as the study continues to full enrolment as planned top line results from the study in the late 2018.

In 2018 we're also focused on expanding our pipelines by conducting additional preclinical development in order to select the next precise base development candidate as well as pursuing external business development opportunities to acquire additional products for our development and potential commercialization portfolio.

So thank you all again for joining us today. We appreciate your continued support. Operator, we're ready to take questions now. .

[Operator Instructions]. And the first question comes from the line of Marty Auster from Credit Suisse. Your line is now open..

Thanks for taking my question guys. I had two quick ones this morning.

First, on the interim, thanks for laying out the possible scenarios for the company, it sounded from what you described like this is not an option but was wondering if you could confirm whether the company has flexibility to expand the planned enrolment for the NEWTON 2 study based on any recommendations coming out of the interim? And then my second question was on manufacturing.

Congratulations on the arrangement with Oakwood securing commercial supply for EG-1962, are there any changes being made to the process between the clinical trial material that was prepared and the commercial material of Oakwood? And then can you walk us through whether CMC or any of the -- if there are any changes that's likely to be a gating factor in terms of timing of your filing with FDA? And in general what your readiness for filing would be if you were to succeed on an interim analysis? Thanks..

Okay, sure. So let me go with first question. So for 1962 the manufacturing with Oakwood, there have been no changes or no substantial changes made as we look forward to the clinical supply to the commercial supply. We've been doing pretty much fine tuning of things but no substantial changes.

So we believe that things are on track if we do hit on the interim analysis from manufacturing standpoint. We believe that things are going at least according to plan. Now as far as the interim analysis and expanding patients, at that time we don't expect to increase the sample size of the study going forward. So we're looking at 374. .

Could you, sorry for the follow-up, but could you confirm if there is flexibility, if there is an adaptive kind of capability in the trial for you to kind of consider adjusting the end if you need to or want to in the interim?.

I do believe there might be, actually let me throw that over to Andrew because I know Andrew you've asked this question recently to Herb..

Yeah, no, that's right Brian. So my understanding is that the DMC cannot recommend an increase in the sample size. We do have some discretion internally as to whether or not we can increase it but as you mentioned our current plans are not to change the sample size of the study. .

Thanks, really helpful. I will get back in queue. .

Thanks Marty..

And our next question comes from the line of Jason Butler from JMP Securities. Your line is now open. .

Hi, excuse me, thanks for taking the questions.

First one, can you just give us any additional color around the feedback you got from payers specifically as well as hospitals when you speak to them about pricing?.

Yeah, I'm going to give you -- Andrew and Ben, our COO have been doing a lot of work on that. So, Andrew do you want to provide some color or additional comments, we are getting a lot of it back. .

Yeah, sure. So I will start off with the responses from hospitals. So we used an independent research company to go to the payer, I'm sorry, instead of hospital I meant payers. So with regard to the payers we used an independent research company to go to five of the largest payers.

We gave them the characteristics of EG-1962 at a 10% to 15% improvement to standard of care. And this is really something just for us to start gauging pricing. So it was meant to cover a wide range of prices and we tested and again this is in our deck that I think is on our website and we've been using at various conferences.

We tested price points from $25,000 up to $150,000 and the responses that we got were varied. Three of the five said they would pay for the product at any price point we tested based on the 10% to 15% improvement in positive outcome. The other two said it would go through various levels of review within their processes.

But none of them said that they wouldn't pay for it at any of the price points we tested. So this is -- look this is indicative, it is positive, it is what we want to hear. It is in no way a guarantee that payers are going to pick up this product right away.

But certainly it gives us encouragement that at a 10% to 15% improvement we can justify premium pricing. In terms of the physicians as Brian mentioned we didn't need to use primary or a research company for that. We have access through locked and through our commercial team to 100s of neuro scientists and surgeons.

And they've been very consistent that a 10% improvement, standard of care is what they need to see to justify moving from the old standard of care which is the oral to our product. So we believe that those are the two keys to getting access to the market and we're very comfortable with it at a 10% plus improvement.

We're going to be successful on both fronts. .

Yeah I would say, to echo the point that Andrew said, the two things we really look at is the clinical point is 10% to 15% with doctors. And that's where we went out and tested it with payers and that's also how we've set up and designed the two studies to show that 10% to 15% effect, absolute difference..

Great, thanks and then just a quick follow-up, have you received feedback from your regulatory agencies that that 10% to 15% benefit over standard of care would also support approval in Europe?.

Yes, we met with the European authorities also. So we believe that the protocol that we're using feels harmonized and as you know we have European centers enrolling as well as other centers outside in Australasia and throughout the world Canada and we didn’t [indiscernible] Canada as well..

Okay great. Thanks for taking the questions. .

Thank you Jason. .

And our next question comes from the line of Paul Matteis from Leerink. Your line is now open. .

Hey, thanks so much, this is Ben Burnett on for Paul Matteis. I had a question about powering of the Phase 3. So for the interim analysis you've said that you need approximately 20% effect for do you want to oral nimodipine.

So I guess just thinking about the variability and the powering at this point if you hit that what is the probability that the interim will be positive, could you guys disclose that?.

Can you ask your question again, I'm not quite sure..

So I guess I was asking, if you hit -- oh, go ahead..

What we have done is -- so we have powered as you probably know we mentioned, we powered the overall study at 85% power. So we didn’t use more chart I can tell you on the interim analysis. So that is why it is a very high level to hit that 20% absolute difference. .

Okay, so you haven’t said commentary around how I guess how the interim would be powered. .

No. .

Okay, that was and just to clarify the 85% powering for the completed study that was for the 10% to 15% that you are talking about. .

Yes, absolutely. .

Okay, and if I may just one more question, just about the patient mix that you're seeing in the Phase 3, do you have any visibility into the baseline WFNS level of patients entering in the study and I guess if you do how does this compare with what you saw in Phase 2?.

So we do have visibility but this is an ongoing study so it's one of those things that we don't give out until the study is completed. We expect to hear -- we expect to be somewhere between the twos and threes and fours to be similar to what we see in general studies in the past. But we don't give out specifics on an ongoing study. .

Okay, okay, thanks very much..

And our next question comes from the line Alex Poshner [ph] from Maxim. Your line is now open. .

Hey guys, you actually answered my questions. Thank you for the call. .

Yeah, thank you Alex. .

[Operator Instructions]. And I'm showing no further questions at this time..

Okay, well then we would like to thank everyone again for the for the questions and for your ongoing support of Edge Therapeutics and hope you have a great day..

Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program and you may all discontent. Everyone have a great day..