Paul Arndt - Investor Relations-LifeSci Advisors Amir London - Chief Executive Officer Chaime Orlev - Chief Financial Officer.

Keay Nakae - Chardan Capital Markets Patrick Dolezal - LifeSci Capital.

Good day and welcome to the Kamada Fourth Quarter and Fiscal Year and 2017 Financial Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Paul Arndt with LifeSci Advisors. Please go ahead sir..

Thank you, Lisa and good morning everyone. This is Paul Arndt with 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 2017.

If you have not received this news release or if you would like to be added to the Company's distribution list, please call Bob Yedid from LifeSci Advisors at area code 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 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, 20-F and 6-K 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, Wednesday, February 7, 2018. Kamada undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.

With that said, I would now like to turn the call over Amir London. Amir..

Thank you, Paul. And thanks also to our listeners for your interest in Kamada and for participating in today's call. I'm pleased to report Kamada's financial performance for full year 2017 was strong and we achieved total revenue growth of 33% compared to 2016.

Our revenue growth continued to be driven by higher sales of GLASSIA in the US for the treatment of Alpha-1 Antitrypsin Deficiency. Last year Kamada's proprietary drug which we manufacture and is from - Shire in the US is part of a strategic agreement between our Company.

Kamada total revenue in 2017 were $102.8 million comprised of $79.5 million from our proprietary product segments which includes GLASSIA and $23.3 million from our Distributed Products segment. Importantly, this result exceeded our previously provided guidance of $100 million in total revenue for 2017.

I should also point out that we closed 2017 on a very strong note as we recorded significant revenue growth of 47% in the fourth quarter versus the corresponding period of 2016. 2017 revenues was Kamada's highest annual revenues when the company was founded. From a stability standpoint, we reported positive operating and net income for full year 2017.

Specifically, we generated operating income of $7.4 million as compared to an operating loss of $5.5 million for the full year 2016 a substantial improvement of $12.9 million. In addition, we recorded $6.9 million in net income that's compared to a net loss of $6.7 million in 2016 an improvement of $13.6 million.

Also our gross profit grew 50% year-over-year and our overall gross margin improved to 31% from 28% with the proprietary product growth margin improving to 35% from 33% last year.

Looking ahead from a top line perspective in 2018, we continue to forecast total revenues within the range of $116 million to $120 million which would represent another year of strong growth versus total revenues for 2017.

This expected growth we primarily resolve from continued GLASSIA sale growth and the launch of KEDRAB in the US which I will discuss shortly. Finally, we enter 2018 with a strong balance sheet including $43 million on cash and short-term investments which provide us with a financial resources needed to continue to executing our business trend.

With a completion of another year of growth in progress I'd like to highlight a few important aspects of our GLASSIA agreement with Shire. As you know, our 20-year agreement with Shire includes two phases.

During the first phase which began in 2010 and currently extend through 2020 we manufactured and sell GLASSIA to Shire, which they market and sell in the US. And in addition have the rights to sell in markets in Canada, Australia and New Zealand.

In the second phase, which extends until 2040 Shire will [indiscernible] GLASSIA and pay royalties to Kamada on their sales. Based on the current agreement Kamada will generate substantial manufacturing revenues in 2020. Specifically, the minimum revenue guaranteed by Shire to Kamada believed [ph] 2018 through 2020 is approximately $177 million.

This potential upside related to possible increase demand. With that said, I'd like to focus on the period beginning in 2021 when the agreement shift to the warranty phase keep Shire sales affecting on GLASSIA on a debt basis [ph].

It's important to understand that the AAT deficiency market in the US is growing approximately 10% annually, which is a very solid growth rate compared to other segments of the biopharma industry and is substantially driven by increasing patient count to better disease awareness and diagnosis [indiscernible] price increase.

Moreover, it's our belief that GLASSIA will continue to capture an increasing market share at the first ready-to-use liquid AAT products and is the only AAT product approved by the FDA for self-infusion. During the royalty period which extends for 20-year if it began in 2021.

Kamada will receive low double-digit royalties on Shire sales on GLASSIA decreasing later to less than 10% royalties. This is an important factor in evaluating Kamada's long-term cash flow generation potential and the company's value. Moving on, let me now discuss another key driver of near term revenue growth for Kamada.

Our anti-rabies IgG product, which received FDA approval in the third quarter of 2017 and will be sold by Kedrion, our commercial partner in the US under the brand name KEDRAB.

As a reminder, rabies is a life-threatening condition that impacts approximately 40,000 people in the US each year representing an annual market opportunity of over $100 million of which we expect KEDRAB to take a significant market share.

KEDRAB is answering the rabies market which due recently is dominated by single supplier and customers in need for another reliable supplier. KEBRAB will be launched in the US in early 2018 and meaningful sale of the product are expected to ramp up throughout the year.

To-date Kamada has sold over 1.5 million vials of our rabies IgG under our brand name KamRAB. In numerous markets outside the US for over $50 million. To give you the product is which we have had significant experience. To this end, in the fourth quarter, we signed a supply agreement with an international organization for our rabies IgG.

This three-year agreement will extend to 2020 is expected to generate revenues for Kamada approximately $13 million. The country working [indiscernible] KamRAB traditionally, commercially, attractive markets globally.

From a commercial standpoint, we expect both GLASSIA and KEDRAB to the primary driver of our revenue and profitability growth over the next few years. Let us now discuss some recent highlights related to our robust clinical pipeline. I will begin the clinical program of our proprietary inhaled AAT for the treatment of Alpha-1 deficiency.

As you know, we are in discussions with FDA to obtain guidance on the clinical and regulatory pathways for inhaled AAT in the US. We expect an improved IND for Phase 3 clinical study by 2018. This approval of FDA, our intention remains initiate the clinical study in the second half of this year.

As previously discussed, we intend to utilize the data to be obtained from this planned pivotal Phase 3 clinical trial if successful to resubmit the marketing authorization application to the European Medicine Agency.

Kamada also has three ongoing clinical programs the AAT, IV AAT in the treatment of graft-versus-host disease, lung transplant rejection and type-1 diabetes.

In regards to AAT for the treatment of acute GvHD, we recently announced an innovative collaboration with Mount Sinai Acute GvHD International Consortium or MAGIC to conduct a proof-of-concept clinical trial assessing the safety and preliminary efficacy of Kamada's AAT IV and preemptive therapy for patients at high-risk for the development of steroid-refractory acute GvHD.

The study will be initiated this quarter and will be conducted in five US centers. All of them are members of MAGIC, which consists of 23 bone marrow transplantation of BMT centered in the US, Europe and Asia. This is an investigator-initiated study, co-funded by Mount Sinai and Kamada.

The study is based on an innovative approach of early intervention driven by biomarkers an algorithm that has been developed by the investigators to diagnose on Day seven following BMT, the patients at risk for non-relapse mortality. The algorithm utilizes proprietary biomarkers or prediction of mortality risk.

Non-relapse mortality is closely related to non-responsiveness to steroids which are current standard-of-care for acute GvHD. Early intervention based on risk prediction and prior to the development of the clinical symptoms of acute GvHD could prevent patients from further disease progression.

Top-line results from this study are expected to be available during the second half of 2019. Importantly, Kamada has exclusive rights to develop and commercialize its AAT IV product for the preemption of GvHD using this biomarkers.

This innovative biomarker driven approach would lead the treatment breakthrough in early intervention treatment for acute GvHD in area of significant unmet medical needs. And highly potential to provide a substantial market opportunity for Kamada.

Therefore, we studies - replaced [ph] previously planned clinical trial that was designed to evaluate IV AAT as the first line treatment for acute GvHD patients. We also recently announced interim results for our Phase 2 trial IV AAT for the prevention of lung transplant rejection which is being conducted in collaboration with Shire.

As a reminder, Phase 2 trial is a randomized open label study of 30 lung transplant patients to value add the safety and efficacy of IV AAT to prevent lung transplant rejection compared with standard-of-care treatment.

This is a two-year study with the first year consistent variation of treatment of AAT and standard-of-care versus standard of care alone and then additional one-year follow-up. The interim for standardized data from the first six months of treatment for the initial 16 patients in the study.

The interim data showed that IV AAT demonstrated a favorable Safety and Tolerability profile consistent with previously observed results in other indications.

The interim report are encouraging and we look forward to the next interim following one-year of treatment for all patients which is effective in the second half of 2018 as well as top-line results from the study, which are anticipated in the second half of 2018.

Importantly the next interim report will include efficacy measures such as lung rejection, pulmonary functions, pulmonary infection, primary graft dysfunction, number of days on ventilator machine and hospitalization duration.

Moving on, as you recall we announced top-line results on our Phase 2 trial of AAT in newly diagnosed type-1 diabetes patients in the fourth quarter of 2017. To reiterate some of those results, well no significant treatment effect was observed in the overall study population.

In the previous term sub-group of patients between the ages of 12 and 18 years old a trend towards better efficacy were demonstrated in the high-dose ARM of 120 milligram per kilogram AAT. Based on these results Kamada in our external pipeline [technical difficulty] key opinion leaders.

They lead us [technical difficulty] in a larger population, [technical difficulty] as such we are proactively seeking a partner for the following development of our type-1 diabetes program.

As I said before, important to note that all of this progress and indications are already in late stage clinical development and each represent a substantial market opportunity for Kamada. With that I will now turn the call over to Chaime. For his review of the financial results. Chaime, please..

Thank you Amir and good day, everyone. To reiterate Amir's earlier statement from a financial standpoint. 2017 was a strong year for Kamada. We exceeded our revenue guidance achieved profitability and are well positioned for future growth. With that, let me begin my financial review by discussing the fourth quarter financial results.

Total revenue for the fourth quarter was $35.7 million, a 47% increase from the $24.3 million reported in the fourth quarter of 2016. Revenue from the proprietary product segment were $29 million a robust 64% increase from the $17.7 million reported in the fourth quarter of 2016. Mainly driven by an increase in GLASSIA sales.

Revenues from the distributed product segment were $6.7 million a 2% increase from the $6.6 million reported in the fourth quarter of 2016. Gross profit was $11.6 million up a substantial 148% from the $4.7 million recorded in the fourth quarter of 2016.

Gross margin improved significantly to 33% from 19% in the prior year period due mainly to a significant increase in sales over GLASSIA. Net income for the quarter was $6.3 million or profit of $0.16 per diluted share compared to net loss of $1.8 million or loss of $0.05 per diluted share in the fourth quarter of 2016.

Moving onto the results for the 12 months ended December 31, 2017. The total revenue were $102.8 million which exceeded our guidance for the year and represented 33% increase from the $77.5 million reported for the full year 2016.

Proprietary product segments generated $79.5 million of revenue, a substantial 42% increase from the $56 million generated for full year 2016. Again driven mainly by increased sales of GLASSIA. Gross profit for the proprietary products segment were $28.2 million a significant 55% increase from the $18.2 million reported in full year 2016.

Gross margin for this segment increased from 33% to 35% in full year 2017. R&D spending for the year totaled $11.9 million a decrease of 26% as compared to the $16.2 million in the same period of 2016. This decrease is mainly attributable for the delay in the initiation of the next Phase 3 study of our AAT inhaled program.

For 2017, selling, general and administrative expenses represent a 12% of overall revenue as compared to 13% during 2016. And finally, net income for the year was $6.9 million or profit of $0.18 per diluted share compared to a net loss of $6.7 million or loss of $0.18 per diluted share for the year ended December 31, 2016.

This represents a $13.6 million year-over-year change driven mainly by higher gross profit and reduced R&D spending. 2017 represents Kamada's first year of profitability and we believe our growing base of revenue from our proprietary products will allow us to remain profitable going forward.

Turning to the balance sheet, at December 31, 2017 the company had cash, cash equivalents and short-term investments of $43 million compared with $28.6 million as of December 31, 2016. As we previously committed to our shareholders. We're pleased to report that we generated positive cash flow from operations of $3.9 million in 2017.

During full year 2017 we invested $4.4 million in capital expenditures require to support our increased production capability and $15.3 million was provided by financing activities including the $15.6 million that we raised in a follow-on offering in the third quarter.

During 2017, our net working capital increased principally due to an increase of $11 million in our trade receivables compared to year end 2016. This increase represents the timing around cash to be received from sales of all products during the fourth quarter mainly to Shire.

During 2018, we expect our cash flow to gradually improve as the year moves along. Most importantly, we expect to be cash flow positive again in 2018. I will now open the call to questions.

Operator?.

[Operator Instructions] we'll go first to Keay Nakae of Chardan Capital Markets..

Couple of questions. With respect to GLASSIA.

What do you estimate GLASSIA's market share in the US for AATD as of this point?.

Data about market share is a public data or data which resides with Shire. We're not publishing the specific data. What I can say that based on public information that we have, Shire in total for the AAT franchise meaning our product and their legacy product is approximately 20% of the market, 20% to 25% of the market. GLASSIA is growing.

We're adding more and more patient on treatment and you see it in our growth of overall GLASSIA sales to Shire in the US..

Okay, with respect to the operating expense in 2018. Just wondering if you can give us a sense of what R&D spending might look like relative to the $12 million that you did in 2017..

For 2017 R&D investment were lower than what we've experienced in previous year primarily due to the delay in moving forward with the next inhaled study.

If you'd like to have kind of benchmark or reference I think you should go back and see what were investment in R&D was in previous years 2016, 2015 and we are planning to be along the same lines of investment in terms of dollar amount, not percentage but dollar amount..

Okay and with the commencement of the Phase 3, should we think about more that R&D spending happening in the back half of the year relative to the front half of the year?.

We expect that the actual R&D or [indiscernible] investment will primarily be start in 2019 - for the inhaled clinical trial.

So the plan is to obtain the IND approval by mid-year to prepare for this study, to initiate the study before the end of the year which we don't expect significant inhaled investment this year, but the actual investment will start next year..

Okay, thanks that's helpful. All right, that's all I have..

We'll go next to Anthony Petrone of Jefferies..

Good morning, this Catherine in for, Anthony Petrone. I have two quick questions and then a follow-up.

First, could you please talk about the market opportunity for IV GLASSIA in treating lung transplant projection patients? And could you also provide more details around the next steps in the clinical development and timing for market plan? Thank you..

Okay, currently the number of lung transplanted patients in the US is approximately 2,000 patients per year and a similar amount in Europe. So we're looking at total population of approximately 4,000 patients. Currently there is no specific treatment for those patients, standard-of-care.

As you know on steroids and [indiscernible] and the current treatment of the dosing and the study we're doing is equivalent to approximately 250 grams of AAT which is similar to the AAT deficiency treatment. But I'm using the numbers of the AAT deficiency reimbursement which are around $100,000 per patients.

It's translating to an annual market opportunity of around $400 million..

Great. Thank you.

And could you also provide an update on Shire order trend for GLASSIA and provide us with the next step for inhalable GLASSIA studies?.

Yes. So in inhaled as I mentioned we're in active discussions with FDA and we expect an IND approval by mid-year so we can initiate the study, the next study which will be a pivotal study for registration in the US and for resubmission in Europe by end of the year.

But this was a timeline to initiate the study, we expect the study to last between four to five years and soon after that assuming successful study to launch the product in both territories..

Great and one last one if you would allow me.

Could you please recap the timeline for GLASSIA tech and money factored and transfer to Shire and give us an update, if any?.

Yes as we described in our update. The current agreement in terms of supply extends until end of 2020 reminding all listeners that this agreement in terms of supply phase has been extended already four times previously by back Baxalta and Shire in [indiscernible] 2010.

So this is information we currently have and if and when we have, additional information we'll be happy to share it with the public. The current agreement in terms of supply until end of 2020 one may feel that start in 2021, Shire will take over manufacturing..

Great. Thank you and congratulations on the good quarter..

[Operator Instructions] we'll go next to Patrick Dolezal of LifeSci Capital..

So the first one here.

I was just curious, if you could give us a little more color on the margins for KamRAB in the US market?.

Yes, so we've not provided specific input stability guidance. So for the product, but what we've said in the past and I will lead to that, that this is going to be highly profitable product from Kamada.

We can sell the product in ex-US, rest of the world markets and for many years and prices in the US are 5x compared with the prices in the countries we've been active so far. We're definitely looking for highly profitable product.

The other market which we're currently targeting as a result of the FDA approval including our announcement from two months ago results to winning in a contract with undisclosed international organization and also is the higher margin [indiscernible] markets. So all in all, this product is going to generate a high margin for Kamada..

Great. Okay. And then I was also curious if you could provide any guidance on the timing updates on Phase 3 trial design for inhaled AAT..

Yes, so we expect an IND approval by mid-year, which will the timing after we finalize the plan and the protocol and the path forward with FDA to share it with the public. We feel it's premature right now to share our discussions once they're finalized, we'll be happy to do that. So we should wait patiently until middle of the year..

Okay, thank you..

At this time, we have no further questions. I would like to turn the call back over to Amir London for any additional or closing comments..

Thank you. In summary, Kamada concluded 2017 extremely well positioned for further success in 2018 and beyond. As I emphasize, GLASSIA is a major growth project in the area of AAT deficiency with attractive levels of guaranteed sales from our partner Shire through 2020.

Kamada will enjoy substantial royalty streams on GLASSIA currently estimated to commence in 2021, which would continue for period of 20-year until 2040. We're in advance discussion with FDA in respect to continuing our inhaled AAT program and if approved, we expect to initiate pivotal Phase 3 trial of inhaled AAT in the second half of 2018.

We have a valuable clinical pipeline focused on IV AAT including GvHD, lung transplant and type-1 diabetes. We also have a strong balance sheet with $43 million of cash at the end of 2017 which provide us with the financial resources needed to continue to grow our business.

And finally, we expect multiple value enhancing milestones expected this year and anticipate 13% to 17% [indiscernible] revenue growth. We remain excited about the positive momentum in our business and look forward to 2018. In closing, Kamada remains committed to growing our business and enhancing long-term shareholder value.

Thank you all for joining us today on the call and we look forward to providing you with further updates on the progress throughout the year. Thank you very much..

That does conclude our conference for today. We thank you for your participation. You may now disconnect..