Good day, and welcome to the Kamada's Fourth Quarter and Full-Year 2018 Earnings Call. Today's conference is being recorded. At this time, I'd like to turn the conference over to Bob Yedid with LifeSci Advisors. Please go ahead, sir.

Thank you, Amanda. Good morning. This is Bob Yedid from LifeSci Advisors. Thank you all for participating in today's call. Joining me from Kamada are Amir London, Chief Executive Officer; and Chaime Orlev, Chief Financial Officer. Earlier this morning, Kamada announced financial results for the fourth quarter and full-year 2018 ended December 31, 2018. If you have not received this news release or you would like to be added to the Company's distribution list, please call me at (646) 597-6989. Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations, future results for Kamada. I encourage you to review the Company's filings with the Securities and Exchange Commission, including without limitation, the Company's forms 20-F and 6-K, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, February 12, 2019. Kamada undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. With those prepared remarks, it's my pleasure now to turn the call over to Amir London, CEO. Amir?

Thank you, Bob. And thanks also to our listeners for your interest in Kamada and for participating in today's call. Let me begin by saying that we’re extremely pleased with the trends demonstrated in our business during 2018. We ended the year with very strong operating performance, specifically total revenues in the fourth quarter were $48.2 million, which represented a 35% increase compared to the fourth quarter of 2017. The strong results in the fourth quarter of 2018 was primarily driven by successful effort to expedite release and shipment over the last year to the U.S. some of which were delayed loss of the third quarter due to the labor strike as well as increased manufacturing efficiency. Our [indiscernible] enrollment in the fourth quarter helps to drive clearly a 2018 total revenue of $114.5 million, an increase of 11% compared to full-year 2017. In general, the overall growth in 2018 was primarily driven by the successful launch of strong sales in the U.S of KedRAB, our anti-rabies IgG product. Our high revenues resulted in greater efficiencies and our profitability metrics include significantly of 2017, that will be further detailed by Chaime. Our 2018 performance is indicative of our successful strategic collaborations, robust operating systems and the proficiency demonstrated by our industry leading team. We are also positioned well to drive further meaningful growth in 2019. In regards to the top line, we are reiterating our previously provided full-year 2018 total revenue guidance of $125 million to $130 million which represent another strong year of a double-digit percentage growth of full-year 2018 total revenue. This reflects continues growth in our Proprietary Products business, principally the growth of GLASSIA and continued growth of our KedRAB product in 2018, which we referred full-year of this product commercialization in the U.S. Looking ahead, I…

Thank you, Amir, and good day, everyone. We are pleased with our robust fourth quarter and full-year 2018 financial performance. We again delivered double-digit percentage revenue growth and our profitability metrics include -- including adjusted EBITDA operating income and net income grew all strong. With that, let me begin by discussing the financial results for the fourth quarter ended December 31, 2018. Total revenues were $48.2 million in the fourth quarter, a 35% increase from the $35.7 million recorded in Q4 2017. Revenues from the Proprietary Products segment were $43.1 million, a robust increase from the $29 million reported in Q4 2017, primarily driven by our ability to expedite release and shipment of GLASSIA to the U.S on account of delayed third quarter product shipment due to delayed [indiscernible]. Revenues from the Distributed Products segment were $5.1 million as compared to $6.7 million recorded in Q4 of 2017. Such decrease was mainly related to timing of sales and product availability. Gross profit was $21.2 million in Q4 2018, a substantial increase from the $11.6 million reported in Q4 2017. Gross margin improved significantly from 33% in the prior year period with 44% due primarily to a significant increase in sales of GLASSIA which contributed to manufacturing efficiency and sales of KedRAB in the U.S. Net income for the fourth quarter of 2018 was $17.7 million or a profit of $0.44 per diluted share compared to net income of $6.3 million or a profit of $0.16 per diluted share in Q4 of 2017. I will now discuss the financial results for the year ended December 31, 2018. Total revenues for the year were $114.5 million, an 11% increase from the $102.8 million recorded in full-year 2017. This total annual revenue are in line with the recently provided 2018 expected revenue guidance…

Thank you. [Operator Instructions] We will take our first question from Raj Denhoy with Jefferies.

Hi. Good morning. Maybe I could start with the rabies, the KedRAB product. You noted in your remarks, I think in the release as well that the primary driver of the success in the growth this year was the launch of that product and the strong sales you’re seeing. Is there anything you could offer in terms of what percentage of the market maybe you’re taking now in the United States, the prospects for continued growth for that product? Anything, any more detail around it would be helpful. Thank you.

Yes. Good morning, Raj. Thank you for joining us today. Thank you for the question. As mentioned in the call, we are very pleased with the launch of the product. The overall market anti-rabies IgG market in the U.S is around $150 million. We have taken a significant portion over the first year and we expect that we can reach anything between 30% to 50% of the market in a matter of two year. So this is our goal. Our target is to consider that Kedrion, our commercial partner is selling in the market, so this is a revenue that they see, while we share the revenues with them.

So if you think about the growth you’ve described for next year, right? Is another -- you think about adding another $14 million, $15 million of revenue in 2019, given the guidance you’ve give us is the majority of that going to be again rabies, the contribution from the product continuing to grow?

Not only the growth between 2018 and 2019 will be on combination of continued growth of last year as well as growing the rabies product in the U.S. From 2017 to 2018, majority of the growth came from the rabies product.

Okay. Maybe I can just ask a couple on the pipeline. So you gave us some updates on GvHD and lung transplants, what is the expectation as when we can start to see revenue contribution? I realized that you’re very early in the clinical work behind these products, but given the unsatisfied need right now the marketplace for products like these, is there a chance that maybe you could expedite the approvals and we could see something sooner rather than later in terms of revenue contribution?

We expect to have results from and to finalize the existing studies with the Phase 2 studies for both indications between 2019 and 2020. And based on the results on those studies, we move forward into Phase 3 pivotal study. Having said that, we are already selling the products for GvHD in an Early Access Program in Europe. So as we mentioned, as being an unmet medical need in the life threatening situation, this is a size of treatment which are considered so early access. We have taken the step with partner company in Europe that it specializes in Early Access Programs and they’re offering solution in the European [ph] market. In the U.S., the situation is different as we know, as we mentioned, all IV indications are partnered with Shire, now part of Takeda. We talk to Takeda to decide if they want to move forward with a pivotal study once we have result from the existing program, and if they would like with our partnership to promote an Early Access opportunity.

Okay. That’s helpful. And my last question is really just, you highlighted the strength of the balance sheet. Maybe you could talk a bit about your plans. Is M&A increasingly important to you? What types of assets will you be looking at? How much urgency should we see from the company in terms of potentially expanding the portfolio here?

So all options are being considered. We will continue to talk within our areas of expertise. We are well funded to move forward within held program independently if that will be the decision. And to use the fund, our resources for business development initiative and also inhaled program. And as we continue progressing our commercial business and we’re generating cash, of course, it will allow us to develop [indiscernible] well positioned and we don’t see [indiscernible] to the market through a [indiscernible] anytime sooner.

And part of the question was really just in terms of the urgency, right? Is there something that the company feel they need to do expeditiously here in terms of building out the portfolio in a sense we are all aware of the 2021 transfer of manufacturing to Takeda, is there activities that are planned in preparation for that in order to sort of use the capacity you have in your own internal facilities or find other sources of revenue for the company?

We are active in the business development field. We are proactively looking for different opportunities. And when we have something to report, we will be happily [indiscernible].

I appreciate it. Thank you.

Thank you, Raj.

We will take our next question from Keay Nakae with Chardan.

Yes, thanks. I wonder if I could just ask again about the 2019 revenue growth drivers. Is that -- should we think about that as being more evenly split between last year in the rabies product in 2019?

Thank you for the question. So like I mentioned, answering the previous question, both products will contribute to the growth between 2018 and 2019 based on the current orders in our production combined scheduling, we expect last year will have a slightly larger contribution to the growth compared to the anti-rabies product.

Okay. That’s helpful. Then with respect to your discussions with the FDA, the trial for inhaled AAT, have you had discussions with them since the government reopened?

Can you repeat the last part of the question? I’m not sure, I understood.

Okay. Have you had just any communications with the FDA since the FDA agency was reopened with the budget negotiations about between [indiscernible] weeks ago?'

Yes, we had. So we had communication and we are actively moving forward in terms of receiving the feedback and we’re optimistic that we will resolve the issue [indiscernible] over the last few weeks, harmonizing the protocol between the two territories, Europe and U.S.

Okay. Very good. That’s all I have. Thanks.

We will take our next question from Patrick Dolezal with LifeSci Capital.

Hi. Thanks for taking the question. The first one here, given the recent acquisition of Shire by Takeda, can you just speak about your relationship with Takeda thus far? And specifically maybe provide a little context regarding the likelihood of expanding the existing supply agreement for GLASSIA?

Thank you. So as we all know, the official closing of Takeda's Shire deal was just a few weeks ago. So only after that discussion with Takeda people have started, we have our contact and we are talking through to the right people on the different topic. And when we have more updates we will definitely do that.

Great. Thanks. And then on inhaled AAT, do you have any additional detail on the anticipated timing of the next FDA response and also how much additional R&D spend might we expect as a result of the launch of that study?

So the timelines have not changed, we have announced that we expect upon FDA positive response through our recent submission, we expect to be able to initiate the study in midyear. Our overall expected investments for the inhaled pivotal study from [indiscernible] is between $30 million to $35 million. Expanded over a few years of five to six years in total [indiscernible] until product launch. So if you divide the amount by the number we use, you can calculate the average annual investments, which Kamada take overall investments independently. And that will be in addition to our R&D investments in 2018.

Great. Thank you.

At this time, there is no more questions. I would like to turn the call back over to Amir London for any additional or closing remarks.

Thank you. In summary, we are pleased with how our business [indiscernible] following the labor strike earlier this year. Our ability to generate total revenue for the full-year, near our initial estimate is indicative of our strength in our business. As we look ahead, Kamada has three important growth driver over the next several years, [indiscernible] KedRAB as well as the pipeline has provided multiple long-term catalyst. Based on expectations, we are excited about our first full-year of commercial sales of KedRAB in 2018, as customers look for stable source of supply in a $150 million market as well as additional regulatory approval of our rabies vaccine, such as the one recently received in Canada. Moreover, our business continues to be supported by a very strong balance sheet as we stand toward a number of key milestones, we are excited about opportunities ahead of us in 2019 and beyond. Thank you for joining us on today’s call and we look forward to providing you with further updates of the progress on our first quarter call. Thank you very much.

This concludes today’s call. Thank you for your participation. You may now disconnect.