Good day, ladies and gentlemen, and welcome to the Protalix BioTherapeutics Inc., Second Quarter 2017 Financial Results and Corporate Update Conference. At this time all participants are in a listen-only mode. Later we'll conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] As a reminder this conference call is being recorded. I would now like to introduce your host for today's program Yossi Maimon, Chief Financial Officer. Please go ahead.

Thank you, Jonathan. Thank you everybody. Good morning and welcome to the Protalix BioTherapeutics first half of '17 earnings results and corporate update. With me today is Moshe Manor, our President and CEO. Just like to remind you that we've just issued the press release announcing the results, which is available on our website. Also I'd like to remind you to take a moment to read the disclaimer about forward-looking statement in the press release, the earnings release and conference includes some forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and in our filings with the US SEC, the Form 10-Q we will file for the second quarter of '17 will also include the detailed discussion of applicable risk factor, as well as our 10-K that we've filed for 2016. With that I will now turn the call to Mr. Moshe Manor.

Thank you, Yossi. Good morning and thank you for joining us. I'm delighted to be here today to discuss the progress we've started achieve over the past few months. We've been able to continue our momentum in the second quarter with involvement progressing for Pegunigalsidase, which is PRX-102 and now Oral PRX-106, deepening partner discussions for Alidornase PRX-110, recording additional sales in Brazil and most recently completing a refinancing and financing to preserve the Company's cash underwriting to 2019, following the conversion of notes that will phase out in cash during the first quarter. On today's call we'll first review our earnings result for the first six months of 2017and then provide a brief corporate update. I'll now turn the call over to Yossi to review the Company's financials.

Thanks, Moshe. So let's begin. For the six months ended June 30, 2017 we reported a net loss of $20.6 million or $0.16 per share, excluding onetime non-cash charge of $38.1 million in connection with the re-measurement of an embedded derivative, compared to a net loss of $19.5 million or $0.20 per share for the same period in '16. The conversion feature as you may recall from the last quarter we discussed, for the Company's 7.5% convertible note was accounted for as a derivative until April 12. On that date we basically got the shareholder approval for the nice market 20% rule. The derivative was separated from the debt component of the convertible note and was measured as fair value in each of the different cut off period. Given the fluctuation in our share and as a result notes fair value, the derivative was increased or decreased against a non-cash charge to the P&L through April 12. Following date, after the shareholders meeting approval the derivative was reversed in its entirety into the shareholders' section and will not be re-measured again and will figure any additional non-cash changes going forward. We recorded total revenues of $9.2 million for the period, compared to $2.4 during the same period in '16. The increase is attributed mainly to the increase in sales of drug that we have shipped to Brazil and from drug substance that we have sold to Pfizer. R&D expenses were $15.2 million, compared to $17.3 million for the same period in '16. Selling General and Administrative expense were $5.4 million, compared to $4.2 million incurred in the same period in '16. The increase is mainly attributed to the increase of activities in Brazil. As of June 30, we had $34.5 million of cash and cash equivalents and in July, we…

Thank you, Yossi. Starting with our lead product candidate, PRX-102 for Fabry disease, we are making great progress with all three clinical trial, the enrollment is ongoing in over 25 active clinical sites globally with most in the U.S. Of significant interest we can share with you today that today all patient switching from pegunigalsidase alfa - to pegunigalsidase alfa from Fabrazyme and the Balance study has been made with excellent tolerability and without any infusion reaction observed. This is an important piece of information and a new piece of data for us as we have seen great safety results from naive patient only and seeing this excellent trend in patient switching from a different ERT is reassuring. Also another important milestone is our clinical trial is that an increasing number of patients in our study have been moved to home care therapy following successful initial infusion periods in the infusion center. This is yet another important indicator as the CIs in the study are becoming increasingly confident in our product candidate, safety profile and the tolerability of the patient to safely switch from a different ERT to our track. This quarter we also received FDA approval for our manufacturing facility to develop not only our current commercial to treat gaucher disease, but also our clinical right candidate PRX-102 to treat Fabry disease. We are very confident and extremely optimistic regarding the potential of our drug candidate to become the drug of choice for all Fabry patients globally with both the potential and superiority in our once every two weeks infusion with our 1 milligram per kilogram dosing regimen and the maintenance of clinical stability with our once monthly 2 milligram per kilogram regimen. Turning to PRX-110, [indiscernible] as I mentioned earlier, our Phase II data was recently the subject…

[Operator Instructions] Our first question comes from the line of Ram Selvaraju from Rodman & Renshaw. Your question please.

Hey, this is Mitchell on for Ram. Thank you for taking our questions. My first question is when does the company anticipate moving PRX-110 into late stage compared or controlled trials in cystic fibrosis?

Can you please repeat your - we can't clearly, barely hear you.

Yeah. When does the company anticipate moving PRX-110 into a late stage compared or controlled trial in cystic fibrosis patients?

Yeah, we actually are now in discussion as we pointed out with - both with preparing with regulatory and with our medical advisory board to design the best, what will be the best study and based on the discussion, it was then and our discussion with partner we'll take decisions on the next phase, Ram.

Okay. And how does the FDA's decision on permitting the NDA submission for Galafold potentially impact the regulatory timeline for completion of development and possible marketing authorization for PRX-102 to treat Fabry disease?

Well, I think this is positive development from our side because as we see the FDA is more open and more flexible in terms of bringing new product based on the need to bring new products to the market. So based on what we understand now, it would provide us the opportunity to actually engage with the FDA after they say once we have the interim analysis or so and to talk about earlier submission after one year - with one year data.

Okay. And what's likely to be the cost of the pivotal development of PRX-102?

So, the total cost of the trial for the development, we estimated to be in the neighborhood of $40 million fully loaded of the way through approval.

Okay, great. Thank you, guys.

Sure.

Thank you. Our next question comes from the line Peter Welford from Jefferies. Your question please.

Hi. Thanks for taking my questions. Just speaking first of all is 102, wondering if there are any final thought to go to the FDA ahead of time the interim data to understand the potential pool that maybe needed for them to consider as a passage or would you have only consider going to the FDA once the interim data are in hand next year? And then on the finances, just wonder if you could I guess talk a little bit about the - it looks as though the shipments to Pfizer was pretty high this quarter if I think 3.6 million were to Brazil presumably the balance were to Pfizer this quarter. So I'm just facing or should we read anything into that? And can you also then perhaps do why the COGS as well was relatively high this quarter compared to what we've seen in prior periods? Thank you.

Sure. Thanks, Peter for the - it's Yossi, I'll try to take these questions one at a time so. The first one, I think it's a good question. I think that our current thinking is to generate the data first, set of data and once we'll have the one-year data from the Balance study by that time we will have longer term data from the Phase I to additional data from other studies. I think that that will give us a very robust set of data to go into the FDA and see how we can proceed. So that's with in connection with the FDA. So we see it as a very positive change in the FDA recently. And I think it's good for us and for the entire Fabry community. As far the shipments that we're shipping to Pfizer the way to think about it is basically we're selling, we're building up inventory. Pfizer is doing - is one of our supplier for the life organization [ph] for the full and finish process. So the way we do it is we sell it to Pfizer and then we buy back from Pfizer when it's a fully packaged file, so some these increased revenues that you see coming from Pfizer basically is kind of an inventory buildup if you will for the shipments, for future shipments into Brazil, directly related to that the cost is higher because those shipments that we're making through Pfizer are basically done at cost de minimis gross profit on those.

That's great. Thank you.

This does conclude the question-and-answer session as well as today's program. Thank you, ladies and gentlemen for your participation in today's conference. This does conclude the program. You may now disconnect.