Kamada Ltd (KMDA) 2014 Q4 法說會逐字稿

Welcome to the Kamada Limited Fourth Quarter and Year End Financial Results conference call. At this time all participants are in a listen-only mode.

Following management's prepared remarks we'll hold a Q&A session. (Operator Instructions)

As a reminder, this conference is being recorded I must advise you this conference is being recorded February 11, 2015.

I would now like to turn the conference over to Ann Marie Fields. Please go ahead, Ma'am.

Good morning. This is Anne Marie Fields with LHA. Thank you all for participating in today's call.

Joining me from Kamada are David Tsur founder and Chief Executive Officer and Gil Efron Chief Financial Officer.

Earlier this morning Kamada announced financial results for the fourth quarter and year end 2014. If you have not received this new release or if you would like to be added to the Company's distribution list please call LHA in New York at 212-838-3777 and speak with Carolyn Curran.

Before we begin I would like to caution that comments made during this conference call my management will contain forward looking statements that involve risks and uncertainties regarding the operations and future results of Kamada.

I encourage you to review the Company's filings with the Securities and Exchange Commission including without limitation the Company's forms 20F and 6K, which identify 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 the live broadcast, February 11, 2014. Kamada undertakes no obligation to revise or update any statements to reflect offence or circumstances after the date of this conference call. With that said, I'd like to turn the call over to David Tsur. David?

Thank you, Anne Marie, and my thanks to our listeners for interest in Kamada and for participating in today's call.

I am pleased to report that throughout the fourth quarter and the '014 year we continued to make excellent progress advancing our leadership position in alpha-1 trypsin for multiple indications with a focus on the treatment of open indications of unmet need.

We stayed focused on our strategic plan to develop core commercial business while advancing our clinical development programs. As a result, we have posted solid revenue performance as well as achieved [compounding] clinical development.

Before I go into the specific commercial and clinical accomplishments, I will turn the call over to Gil Efron, our CFO for detailed review of our fourth quarter and yearend financial results. Gil, please.

Thank you David and good day everyone. As David noted, the fourth quarter in particular was a very strong period for Kamada. I'm very pleased to report that we achieved record revenue in the fourth quarter and delivered 2014 full year revenue at the top end of our total financial guidance.

Total revenue for the fourth quarter of 2014 was $25.8 million compared with $24.4 million in the prior year fourth quarter and $17.1 million in the third quarter of 2014. Revenue from the proprietary products segment was $20 million compared with $18.6 million in 2013 fourth quarter and $9.1 million in the third quarter of 2014 with the changes being primarily due to ordering patents of Glassia from Baxter.

The revenue from distribution segment was $5.8 million in both the fourth quarter of 2014 and 2013. Total revenue for the 2014 year was $71.9 million compared with $70.6 million in 2013. Proprietary products revenue for the year was $45.2 million compared with $50.7 million in 2013, which included a $4.5 million milestone payment. Excluding this milestone payment, revenues from proprietary products in 2014 were the same as in 2013.

This is largely due to ordering patents from Baxter. 2014 revenue in the distributed products segment increased 34% to $26.7 million from $20 million in 2013. In September 2014 we executed an extension to our agreement with Baxter that provides for minimum revenues from 2010 to 2017 of $191 million up to $165 million in a 2013 extension and up from $110 million in the original 2010 agreement. At year end 2014 the cumulative remaining commitment from Baxter is approximately $70 million, leaving a meaningful purchase obligation and revenue stream for the coming years.

Turning to the rest of the P&L, R&D expenses for the fourth quarter decreased to $3.4 million from $3.6 million in the fourth quarter last year and from $4.2 million in the third quarter of 2014. The decrease was primarily due to changes in activities in activity in support of various clinical studies including three key clinical trials, the closing and analysis of the European Phase 2/3 study of inhaled AAT, as well as a decrease in the fourth quarter of facility costs allocated to R&D use compared with prior quarters.

R&D expenses for 2014 of $60 million increased from $12.7 million in 2013 as we continue to support various clinical studies, specifically the three important clinical trial during the period as I just referenced and due to higher facility costs allocated to R&D on various R&D projects.

During the fourth quarter of 2014, SG&A expense decreased to $2.4 million from $2.9 million in the prior year largely due to a decrease in expense for doubtful debt. SG&A expenses for the 2014 year increased to $10.4 million from $10 million in 2013.

Gross profit for the fourth quarter of 2014 was $8.0 million compared with $8.9 million in the fourth quarter of 2013 and $4.4 million in the third quarter of 2014. The decrease in gross profit in the 2014 fourth quarter is a result of lower revenue and product mix within the Distributed Product Segment, as well as excess capacity in the Proprietary Products Segment during the year that led to higher costs [avail] in the short term and due to a one time sales incentive in certain markets.

Fourth quarter gross margin of 31% declined from 36% a year ago and increased from 26% in the third quarter of 2014. Our gross margin was affected by the reasons mentioned before. Full year 2014 gross profit decreased to $15.6 million from $26.4 million in 2013, with gross margin declining to 22% from 37%. Excluding the three million inventory write-off in the second quarter of 2014 and the $4.5 million milestone payment in the second quarter of 2013, gross profit for 2014 decreased to $18.6 million from $21.9 million in the prior year.

We reported operating income of $2.2 million in the fourth quarter of 2014 compared with operating income of $2.4 million for the year ago fourth quarter and compared with an operating loss of $2.5 million in the third quarter of 2014. The operating loss for 2014 year was $10.9 million compared with operating income of $3.7 million in 2013.

Net income for the fourth quarter of 2014 was $1.7 million or $0.05 per diluted share, compared with net income in the prior year fourth quarter of $1.6 million or $0.04 per diluted share, and compared with a net loss of $2.9 million or $0.09 per diluted share in the third quarter of 2013. Adjusted net income for the fourth quarter of 2014 was $2.4 million compared with adjusted net income of $2 million for the same period in 2013 and compared with an adjusted net loss of $1.9 million in the third quarter of 2014.

Net loss for the full year 2014 was $12.6 million or $0.35 per share, compared with a net income of 500,000 dollars or $0.01 per share in 2013. Adjusted EBITDA for the fourth quarter of 2014 was $3.6 million compared with $3.5 million for the fourth quarter of 2013 and compared to a loss of $800,000 in the third quarter of 2014. Adjusted EBITDA for 2014 was negative $4.4 million, compared with positive $9.4 million for 2013.

Looking now to the balance sheet, we closed the year with cash, cash equivalents and short-term investments of $51.9 million which compares with $74.2 million as of December 31, 2013. During 2014 year we used $9.9 million in cash to fund operations, $3.1 million for capital expenditures and $7.7 million for repayment of convertible debt. With that overview of our financial performance, let me now turn the call back to David.

Thank you Gil. We are pleased with both our commercial and clinical progress and execution of our strategic plan to grow our core business which provides significant cash flow and supports our robust clinical development program.

Throughout 2014, we accomplished several important objectives that will strengthen our core revenue base over the coming year and beyond. We executed the second extension for our strategic agreement with Baxter for Glassia to treat Alpha-1 Antitrypsin deficiency for AATD in the US which increased Baxter minimum purchase obligation to $191 million and extended the agreements [well for] 2017 with a transition to royalty revenue from this agreement not before 2018.

In addition, with FDA approval of a meaningful enhancement to our infusion rates for Glassia following this study conducted by Baxter. These enhancements considerably reduce the patient's weekly infusion time from over an hour to approximately 15 minutes and provides Glassia with significant patient benefits.

AATD augmentation and maintenance therapy represents approximately $750 million market that is growing approximately 10% a year due to better diagnostic and disease awareness. Glassia is the only ready to use infusion product on the market. This along with reduced infusion time gives Glassia a significant competitive advantage and strengthens the strategic partnership between Kamada and Baxter.

Our strong partnership with Baxter including the committed orders for the coming year and the consistent increase in number of patients treated by Glassia which grow by 25% during '14 gives us strong visibility including increasing number of patients being treated by Glassia worldwide, which we expect will double within the next four to five years. US growth for Baxter along with increasing sales of Glassia in the six other countries, around the world where we market the product are expected to provide platform from which we can achieve our midterm revenue goal of $100 million revenues in 2017, including approximately 75% growth in the proprietary products segment by 2017.

In order to support this anticipated growth we engineered important enhancements to our manufacturing processes which receive FDA approval in mid '014. These enhancements support efficiencies and provide for the nearly 50% increase in capacity which will allow us to improve profitability and provide ample supply for the growing sales of our proprietary protein plasma therapeutics and for our expanding clinical development program.

Turning now to a discussion of our robust clinical pipeline which features a mix of late and early stage development programs. In the fourth quarter we continued to generate favorable data from studies with our IV antitrypsin to treat newly diagnosed type 1 diabetes and to treat graft versus host disease or GvHD, both orphan indications with significant unmet medical need, importantly our improved infusion rate can be used for these indications as well.

In October the FDA granted orphan drug designation for our intravenous Alpha-1 Antitrypsin therapy to treat GvHD which is a major complication of allogeneic hematopoietic cell transplantation or HCT. Severe acute GvHD can be life threatening and it is associated with the loss of proteins including AAT.

There are no drugs specific for GvHD approved by the FDA and current treatment is serious adverse event. Consequently, there is a great need for an effective treatment in this often indication with amounts approximately in excess of $500 million.

Glassia is expected to decrease GvHD related symptoms including progressive tissue damage and thereby potentially increase survival rates and possible reduce or eliminate the need for steroid therapy.

In December we were pleased to announce that positive [inter-linked] data from phase one-two clinical study being conducted by the Fred Hutchinson Cancer Research Center in Seattle, Washington using our AAT therapy for the treatment of GvHD were highlighted in a poster presentation at the 56th American Society of Hematology Annual Meeting.

Preliminary results indicate that continuous administration of AAT as therapy for steroid resistance [got] GvHD is feasible in the subject population. Indication of healing of the [bottom quarter] was seen to decrease in the area in intestinal protein loss including AAT and endoscopy valuation, additionally the preliminary results show that following the elimination of poor inflammatory cytokines, AAT administration suppressed serum levels of poor inflammatory cytokines and interfered with GvHD analysis.

Given the federal safety profile of Glassia is a strong rationale to support the development of this new indication and increase likelihood of our AAT becoming an effective therapy for this potentially life threatening disease. We look forward to the continuation of this important study and reporting additional findings.

In addition to GvHD we are evaluating our AAT therapy as a treatment for newly diagnosed type 1 diabetes in pediatric patients. This is also a treatment for which we have [often] drug designation status from the FDA.

Most recently we are pleased to report additional data from ongoing extension study with our open label phase one two clinical trial in this indication which showed that the majority of patients who continued treatment with AAT maintained capacity of insulin secretion and attained the [same] target with HbA1c level below 7.5% for more than two years after their diagnosis of type 1 diabetes.

Treatment of type 1 diabetes patients with Kamada AAT may have several medical benefits, including slowing the progression of the disease, improvement of body control, reduction of daily [saline] dose requirements and most importantly reduction of diabetes complications.

We are encouraged by the ongoing positive results from the extension study of our phase one two trial as they corroborate with earlier results from this study and demonstrate the ability of the effect of Kamada AAT treatment in newly diagnosed type 1 diabetes.

Despite the limitation of small sample size, this result are favorable. The scientific rationale for the [destination] of AAT to treat type 1 diabetes is based on the anti-inflammatory immune [modulatory] activity of AAT which was recently published in the Journal of Diabetes Science and Technology. This mechanism of actions support better (inaudible) processes of autoimmune mediated issuing (inaudible).

We continue to believe that our IV AC can be groundbreaking treatment for newly diagnosed type 1 diabetes patients. Patients may demonstrate the ability to halt disease progression and allow the pancreas to maintain [progression of self] insulin. Moreover, this favorable data validates our enthusiasm as we continue to enroll patients in our phase two three clinical study underway in Israel and for which we have plans to expand internationally.

Turning now to our late stage program with AAT therapy, our inhaled alpha-1 to treat alpha-1 deficiency. In September last year we reported data analysis from our European phase two three study of inhaled alpha-1 to treat alpha-1 deficiency.

(Inaudible) the primary and secondary endpoints. Important, very important lung function parameters showed concordance of potential treatment effect in the reduction of inflammatory injury to the lung which is known to be associated with reduced loss of respiratory function.

This data are very promising and important as they demonstrate improvement in lung function parameters that will [tough] not to be sustained in the study of such short duration and in so few patients studied.

We remain encouraged by the constructive dialog we had with the European co-rapporteurs regarding our plans to file for approval with the European Medicines Agency for our inhaled AAT as a treatment for AATD. They agreed that the application fulfills the requirements relating to unmet medical need and benefit to public health, and that it may meet the scope of Conditional Approval if the Company convincingly proves the positive benefit-risk balance of the product by the time of Marketing Authorization Application, MAA filing.

The co-rapporteurs have requested the addition of supplemental data analyses that may address the benefit-risk balance and support the already available safety and efficacy data. We are in the process of conducting the additional analyses and plan to file the MAA with the EMA in this year's fourth quarter. In addition, we expect to present the complete data set from the Phase 2/3 clinical study in advance of the upcoming American Thoracic Society Annual Meeting in May 2015 in Denver.

In conjunction with the ATS meetings we plan to host a two hour seminar to present our inhalation results. This meeting will feature an expert panel of clinicians who are considered the leading specialists in treating AATD. We will be reporting more about this as we get closer to the event. We continue to enroll and treat patients in our US phase two clinical study of inhaled alpha-1 to treat AATD.

The staff is testing for PK parameters in epithelial lining fluid and serum as well as for safety and tolerability. This is an important study that the FDA requires for approval. We look forward to completing enrollment of this study by midyear and to reporting the data in the second half of next year. We intend to use the study that along with those from the European phase two three study discuss our (inaudible) pathway in the US and FDA.

Finally, let's review our US phase three study of anti-rabies immunoglobulin for the post-exposure prophylactic treatment of rabies. As previously announced, we expect to be pro-data from this pivotal study by mid-year, and subject to positive data, expect to file a Biologics License Application with the FDA in the second half of 2015. We have a strategic partnership for the clinical development, sales and marketing of this product in the U.S. with Kedrion Biopharma.

In the US there are approximately 40,000 post exposure prophylaxis treatment administrated each year, representing a nearly $100 million market opportunity. In addition to other opportunities to our rabies prophylaxis as the World Health Organization estimates that each year approximately 10 million people worldwide require medical treatment against rabies after being bitten by an animal suspected of rabies infection.

We use one significant provider of anti-rabies immunoglobin in the US. We anticipate a healthcare provider will want to diversify the source of supply particularly if competing high quality products approved for use.

In closing, our accomplishments in 2014 have laid a foundation for us to grow our core commercial business and advance our clinical programs. As a result, we have a number of important milestones in the coming months and year and should create value for our stakeholders.

And finally, Kamada is a strong based business. We have secure orders in target of $100 million revenues during '017.

We are planning to double the number of alpha-1 patients on drugs by '018. We have completed two phase three clinical trials during 2014 that will be available during second quarter 2015. We have three ongoing phase two clinical trials for type 1 diabetes, GvHD, inhaled alpha-1 in the US. We have a strong partnership with leading companies like Baxter, Kedrion, Chiesi and others, and in preparation of our coming opportunities we have hired additional VP Medical Director and extending staff and budget in regulatory [space] and business development.

And now operator, please open the call for questions.

(Operator Instructions)

If you're using a speaker phone please pick up your handset before entering your request. One moment please for the first question.

Our first question is from Raj Denhoy with Jefferies. Please go ahead with your question.

Hi, good morning. I wonder if I could start a little bit with the proprietary products segment in the quarter. I'm not sure if you'll give us these numbers, but how much of the proprietary sales were Glassia versus your other proprietary products?

We didn't give this number yet. We will provide it in 20F. But this was a significant portion of the revenue in the quarter.

I guess what I'm trying to understand is you know the proprietary product sales as you describe them, if you exclude the milestone payment of second quarter of last year, were essentially flat. But it seems like the Glassia sales through Baxter seem to be accelerating or picking up by some of the descriptions you provided, so I'm trying to get a sense of how those two different pieces are working together in terms of the other proprietary products versus the Glassia piece in 2014.

I think if you look on - what David has just mentioned our target to reach about $100 million in 2017 and then looking into doubling the number of the patients that own Glassia worldwide, and the major portion of it is from in the US and -- this is the way we are looking to achieve. So we look on the ability to grow the revenue from Baxter in the midterm and that will be part of this growth in revenue that we believe we will reach by 2017.

Which that was sort of my second question. So then you think about 2017, if our numbers are rough, you know, Glassia is maybe a $30 million, 31, $32 million business for you right now. So when you get to $100 million, Glassia will be about $60 million of that or so? And the balance will come from the other proprietary product which will be inclusive I guess as some of the new indications graft versus host, the rabies, potentially even diabetes at that point?

Yes. I cannot confirm the number that you have mentioned, but this is probably the way to think about it, if we are looking to double the number of patients on Glassia worldwide.

Okay. But in terms of that other piece, if the balance is $40 million, would you offer in terms of you know, if it is those new indications that you're working on, how much you expect each of those to be contributing by 2017? Or even if you want to offer which of them will be the biggest contributors come 2017?

If you look on the indications in the pipeline, in Europe the health product if approved, assuming that we will file by the end of this year, it will not get into the market before 2017 and will not contribute a significant portion in 2017, and then I would say very similar with the rabies, we will file in the second half of this year with the EMA and we should assume that we will start reaching the number only towards the beginning of 2017.

Okay. Well again, so then the balance of that $40 million will come from where? Is that graft versus host or some other...

No it will come from the existing product that we have today in [DAM].

Okay. So none of these new indications are yet in that number. Sorry to be a bit obtuse, but...

Yes, the number will come from specific (inaudible) not new indications.

Okay. That's very helpful. Thank you.

And then may I just ask one on inhalable in terms of your discussions in the United States with the FDA. Maybe you could provide an update on where you are in the trial here in the United States if you had any discussions with the FDA in terms of how you're going to progress from this point.

Yes as we have mentioned, the trial in the US is still ongoing, and we're planning to approach the FDA in second quarter of this year to discuss the regulatory pathway in the US following the results that we have and additional analyses that we are conducting in the trial in the US.

Okay thank you.

Your next question comes from the line of Yigal Nochomovitz with Oppenheimer. Please go ahead with your question.

Hi, thanks very much for taking my question. You know just going back to the $100 million number. Just to clarify, is this the first time that you've introduced this $100 million so-called guidance in 2017, and just so I understand correctly, given the 75% growth in proprietary driving this estimate, at least the way I do the math, it seems that that implies about a 20% decline in the distribution segment which seems a bit conservative, so can you just clarify if that's the right way to think about it? Thanks.

First of all, yes, this is the first time that we've introduced them, this number. We do not foresee a decline in distribution in that segment.

Okay. I guess I was just doing the $45 million run rate times the 75% growth in the proprietary, it's due about $80 million in proprietary, which is how I got to $20 million in distribution which seemed like a bit of a decline, but that's not the correct way to model?

I think what we are trying to say is the growth will come from our proprietary products and mainly from the Alpha-1 Antitrypsin to treat alpha-1 deficiency.

Okay great. And then on going to the clinical side, on the GvHD study, I would be interested to know are we going to see more data in the phase one two in 2015 beyond the first cohort, 30 mg/kg, and are you, you know, how much are going to push the dose in eh second through fourth cohorts in that study?

Yigal, thank you for asking. I will pass the question to Pnina Strauss, our VP of Clinical Development in IP that she has joined us.

Hi, hello, good morning. Well with regard to the GvHD trial, currently we are in the process of continuing enrolling patients into the second cohort, and it is assumed that by the end of this year there would be additional new data probably again in the ASH conference in presentation of an abstract with additional data to support the second cohort. At the moment, the clinical has progressed as planned. Second cohort is another dose range, and we will provide the data once we have analyzed the information.

Okay great. And just on the inhaled plans. Could you provide any additional color on what sort of types of additional analyses you are looking at that have been requested by EMA?

Well we have been meeting with the rapporteurs, the EMA representatives for submission, and as mentioned by David, they have requested additional types of analysis to further demonstrate the benefit, the efficacy that is arising from the study in lung functions and others. So we are currently focusing on these analyses, planning to submit these to the authorities when complete.

Maybe worth mentioning, Yigal that the figures that we received from the [outside carriers] that they would be looking at the totality of the data and then will not reject [first work] analysis, so it's important that we continually analyze the data.

Okay great. Thank you very much.

Your next question comes from the line of David Lewis of Morgan Stanley. Please go ahead with your question.

Hey good morning. This is actually [James] in for David. Thanks for taking the question.

First I wanted to talk a little bit about Glassia. As you look forward to your target of doubling the number of patients in the next several years, what do you see in the marketplace that gives you the confidence that you'll be able to get to that number, and in particular, what does that assume from a market growth perspective and what does that assume from a share perspective? You know is this a function of a faster pace identification, or is it a function of Baxter converting more of their Aralast business to Glassia, or how should we think about that?

Thank you. The market dynamics that market is growing by 10% to 12% annually, and we expect it to continue and even increase, and the specific goals of Glassia is due to both new patient identification and the advantages of Glassia over any other drug in the market today, and we see in effect that this is, the performance in 2014, we have been growing number of patients at 25%, and we are working in close relation to Baxter. If you go to the conferences, you can see that Baxter is promoting Glassia only and based on forecast of actual number of patients on marketing activities, we are confident that this will happen and we are preparing for larger volumes, especially during 16 and 17.

That's helpful. And of the $191 million in guaranteed or rather committed Glassia purchases, how much is still to come?

As I mentioned, it's about $70 million.

Okay perfect. And then finally just on rabies immunoglobulin. Anything you can tell us about you know, your expectations for share upon launch and how much that particular product is contributing to the growth to the $100 million target through 2017?

We expect and hope that rabies will be launched in the US during '17, but in our model we incorporated a modest figure of rabies sales in the US also an important contribution to profitability, and usually when there are two players in the market you would expect both of them to have an important market share. I can tell you that the rabies already sold in 10 countries and each of their markets we have at least 50% market share. I don't if we will reach 50% market share, definitely not in the first year, but our target within time is to have an important market share. I don't know if it will be 25% or 45% but we expect within years to reach an important market share.

Okay that's very helpful. I will get back in queue.

Your next question comes from the line of Adnan Butt with RBC Capital Market. Please go ahead with your question.

Well good morning. Just a couple of questions here. first, did I hear correctly that the phase two US study, the inhaled AAT study, the data for that would be in 2016, so that's next year? And then from the ongoing phase two study, are there any activity measures the Company is looking at as whether they are functional or buy marker related?

Could you repeat the second question? We couldn't hear it.

So from the US phase two study. Are there any activity measures, you know biomarker or functional the Company will be evaluating over the course of the year?

Okay. Hi, hello, this is Pnina Strauss. Well with regards to the data, it is still not clear when exactly the data will be published. However, we are planning to complete this study within the second half of 2015 and most probably the data will be published 2016.

With regards to biomarkers, this is - [the advent] of a PK study that is aiming to measure different biomarkers at ELF, epithelial lining fluid in the lungs, and different biomarkers in serum.

So in terms of functionality, the functionality that we will examine is based on biomarkers which is for example, functional AAT or a different, again, biomarkers that indicate functionality of AAT as well as different biomarkers indicating activity. For example, anti-inflammatory cytokines or pro-inflammatory cytokines and same goes for biomarkers in serum. So I hope this answers your question.

That's fine. Thank you so much.

Your next question comes from the line of Steven Tepper with Migdal Capital Markets. Please go ahead with your question.

Hi, thank you for taking my question. I have a couple of question regarding the inhaled products. Have you got any indication from EMA what type of data or phase four study will you be required to conduct if you get that and conditional approval? The second issue that would be interesting to me, is do you have any indication in regarding the reimbursement in different countries and Europe?

Do you have any development on the reimbursement issue for this product based on the understudy that you've conducted? And the third thing is regarding Chiesi. Is there any, is there any trigger that will require them to make some kind of payment if you get approval, or you submit to the EMEA, is any trigger or some kind of milestone?

Thank you for the question. We expect that we might be able to perform a [post-liken fluid] trial and we have to submit our proposal to the EMEA when we file the MEA during last quarter of this year. So we are working on trial design and we will be glad to share with you in due time.

Regarding the collaboration with [PAC] and their clinicians, we are working in close relations and we are meeting from time to time and we all met with the EMEA, and we are working on the next submission to the EMA in '15. If this will trigger a payment, I think that what we believe that milestone payment from PAC is to do with regulatory submissions and milestones, but we didn't mention any specific amount or a milestone.

As to the reimbursement, you know today in Europe while the potential is at least as big as in the US our only 2,500 patients on drug. Mainly in Germany, Spain, France, Austria, Italy and there is full reimbursement also never efficacy results were submitted to the regulators.

And this is why we design our trials to meet the requirements and we believe that we will be able to show that the results that we obtain convincing and we will be able to show the whatever is necessary to get the reimbursement in those countries where the drug is already reimbursed.

And on top of this, in additional markets and geography where the drug is not reimbursed today because the [need and alike] of efficacy data, and we believe that we will have the necessary supporting data to get a centralized registration and to be able to launch the product in those countries where it is already sold [reimburse] in additional countries where the product hopefully will be registered and reimbursement will be in place and to create more awareness to additional patients will be identified and treated.

Okay thank you very much.

(Operator Instructions)

Next you have a follow-up question from Yigal Nochomovitz with Oppenheimer. Please go ahead with your question.

Yes hi thanks. I was just wondering on the ATS conference, are you going to be presenting at the conference, or are you going to be presenting outside the official conference when you discuss the phase two three data? Thank you.

We are planning to release the additional data ahead of the ATS conference and to present outside of the conference itself.

Okay great. Thank you.

There are no further questions at this time. Mr. Tsur, please proceed with your presentation or any closing remarks.

Thank you everybody for participating on this call. I would like to know that we will be participating in the upcoming global health conference taking place in February 24 and 25 in New York and the Cowen Healthcare Conference taking place March 2 to 4 in Boston, and for those attending the conference and would like to meet with us, please reach out to your respective RBC or Cowen representative or contact Ann Marie Fields or - at LHA. David, please.

Thank you for your questions and your continued interest in Kamada. We look forward to updating you again when we report our first quarter 2015 financial results. Have a good day. Thank you very much.

Ladies and gentlemen, that concludes your conference for today. We thank you for your participation and ask that you please disconnect your lines.