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Kamada Ltd. (KMDA)

Q4 2016 Earnings Call· Mon, Feb 6, 2017

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Transcript

Operator

Operator

Good day, and welcome to the Kamada Fourth Quarter and Fiscal Year 2016 Earnings Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Paul Arndt. Please go ahead, sir.

Paul Arndt

Management

Thank you, Amie. Good morning. 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 Gil Efron, Deputy CEO and Chief Financial Officer. Earlier this morning, Kamada announced financial results for the 2016 fourth quarter and the 12 months ended December 31, 2016. If you have not received this news release or if you’d like to be added the Company’s distribution list, please call Bob Yedid from LifeSci Advisors 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 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 the conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, Monday, February 06, 2017. 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 like to turn the call over to Amir London. Amir?

Amir London

Chief Executive Officer

Thank you, Paul, and thanks also to our listeners for your interest in Kamada and for participating in today’s call. We are very pleased with both, our financial performance and the progress achieved with our development pipeline in 2016. We believe we’ve laid a strong foundation in 2016 that positions us well for further success in 2017, including attaining our previously stated objective of reaching $100 million in total revenue in 2017 as well as generating positive cash flow this year. Before I look ahead to 2017, let me discuss some of our significant 2016 achievements. Let me begin with some key financial metrics. First, our sales of GLASSIA continued to be robust and helped to drive year-over-year growth of 30% in our Propriety Products segment and 11% year-over-year growth in total revenue. I will discuss last year’s progress shortly in the context of our recently extended agreement with Shire, but this product continued to perform exceedingly well with over 25% increase in number of patients treated with GLASSIA globally in 2016. This provides us with confidence that our 2017 revenue and cash flow expectations are achievable. Looking again at cash flow, we reached cash flow breakeven in the fourth quarter of 2016. In addition our gross profit grew 40% year-over-year in 2016 and our gross margin improved to 27.9% from 22.6%. Gil will provide a detailed review of our financial results shortly. So, let me now move on to our market growth and development, and operational accomplishments in 2016. Let me begin with our proprietary inhaled Alpha-1 Antitrypsin therapy for the treatment of Alpha-1 Antitrypsin Deficiency, which is important progress for this product candidate in both the Europe and the U.S. Before I detail this progress, let me remind you that we believe our inhaled AAT represents an attractive…

Gil Efron

CEO

Thank you, Amir, and good day, everyone. Kamada’s financial performance in 2016 was quite strong, and we are in an excellent position to grow our business further in 2017. Let me begin my review of the financials with the discussion of our fourth quarter results. I follow this with the review of our results for the 12 months ended December 31, 2016. Total revenues for the fourth quarter of 2016 was $24.3 million, a decrease of 5.5% from the $25.6 million for the fourth quarter of 2015. Revenues from the Proprietary Products segment were $17.7 million in the fourth quarter of 2016, flat as compared to the 2015 fourth quarter. It should be pointed out that our Proprietary Products revenues in 2016 were back-ended toward the fourth quarter, while 2016 Proprietary Products revenues were more evenly recorded throughout the year, resulting in difficult comparison for the fourth quarter of 2016. For the fourth quarter of 2016, Distributed Products revenue was $6.6 million compared with $8.1 million in the same quarter of 2015. The decrease was due to increased competition for this product. Gross profit for the fourth quarter of 2016 was $5 million, a decrease of 38% compared with $8 million for the fourth quarter of 2015. Gross margin decreased to 20.5% compared to 31.4% in the fourth quarter of 2015. The decrease in profitability was mainly due to a one-time $2.6 million inventory write-off and unexpected temporary shutdown of our manufacturing plant. Our plant has already returned to full functionality during the fourth quarter. Looking now to the rest of the P&L, R&D expenses in the fourth quarter of 2016 were $4.2 million, below the $4.5 million in the fourth quarter of 2016. Selling, general and administrative expenses in the fourth quarter of 2016 were $2.6 million, a decrease…

Operator

Operator

Thank you. [Operator Instructions] We’ll take our first question from Raj Denhoy of Jefferies. Please go ahead.

Raj Denhoy

Analyst · Jefferies. Please go ahead

Hi. Good morning. I wondered if I could ask a couple of questions, first on rabies in United States. If there is any update in terms of timing around approval for rabies in United States? And then just to clarify again that you haven’t included anything for that product in the United States in your 2017 guidance?

Amir London

Chief Executive Officer

Hi, Raj; it’s Amir. First of all, the PDUFA date is end of August of this year, and we expect a positive response, positive feedback. So, with that PDUFA date, we expect to be able to launch the product towards the end of the year or beginning 2018. We have not included any projection for rabies in the U.S. in our $100 million estimation or forecast for this year.

Raj Denhoy

Analyst · Jefferies. Please go ahead

Okay. And then, when you think about that -- the process of generating sales in United States, I mean is it -- I mean, there is only one other competitor; so, is it a question of sort of getting on formularies or tenders or how do we think about the pace at which that business could start to contribute you even if it’s in 2018?

Amir London

Chief Executive Officer

Okay. So, as you said, there is one predominant supplier in the market. The second supplier, Sanofi, has lost significant market share due to shortages over the years, by the way not only in the U.S. And the market is expecting, and we hear it from the buyers that they are expecting a second trusted supplier, and we plan on being that supplier. Every hospital has to have anti-rabies IgG on their shelves. So, they are expecting to have at least two trusted suppliers; we will be that second one together with Grifols.

Raj Denhoy

Analyst · Jefferies. Please go ahead

Okay. And then, maybe could ask about the Shire relationship. I mean, as you noted, it’s been extended to 2020, it seems to be quite beneficial to you. But, may you could talk a bit about your understanding of Shire’s plans here. They had been constructing a facility in Europe to take production at some point. Is that still the case? Do you have any insight into what their ultimate plans are in terms of whether they’re going to assume production or whether they’ll continue to source it from you?

Amir London

Chief Executive Officer

So, as it’s happened in the past, our agreements, supply agreements with Baxter and Baxalta and Shire have been extended already four times in the past. We don’t have any visibility beyond 2020 currently. They may decide to construct their plant and make the product themselves, then we’ll be moving into the royalty based portion of the agreement or they will ask us to continue supplying them with the product. So, they still have time to make the decision. I’m sure that in due time, we will have sufficient capacity to support an extended number of patients in the U.S. as we’ve done in the past. For the last six years or seven years since the agreement has been signed, we haven’t missed a single shipment. So, either or they continue buying it from us after 2020 or they make the product themselves, we believe we are in a good position. Once we have any clarity from Shire beyond 2020, we’ll definitely update the market.

Operator

Operator

We will take our next question from Lauren Chung with Maxim Group. Please go ahead.

Lauren Chung

Analyst · Maxim Group. Please go ahead

Hi. Good morning. Thanks for taking my call. I had a question about your pipeline on the AAT IV for the acute Graft-Versus-Host Disease. You mentioned that you’re waiting from the European regulators about the trial design. How do you envision that trial design versus the U.S. design, and do you envision those trials -- you said you will be running in parallel; could you give me some more color on that timeline of those?

Amir London

Chief Executive Officer

Yes. We already have discussion with European and we’ve got feedback through Scientific Advice discussions, and that is of course very encouraging, very positive. Basically, they accepted the design of the U.S. study with some comments, some modifications. We are meeting in the next two weeks with our advisory board for Europe to digest that feedback and be able to make some modification to the current study, so we can submit a CPA and get approved CPA for Phase 2/3 study in Europe this year. This is our plan for the year. We are planning to run a parallel to the U.S. study. As you may know, the rights for the AAT IV indication in the U.S. are already Shire’s rights, based on the agreement signed in 2010, and we are collaborating with Shire in the U.S. while in Europe we have the right and we plan on continuing independently. And this is one of the reasons for parallel two studies which we’ll be running in both territories.

Operator

Operator

[Indiscernible] Please go ahead.

Unidentified Analyst

Analyst

Two quick questions. The first, can you give some more color on the write-down maybe in the last quarter? And second, what can we expect profitability wise in 2017?

Gil Efron

CEO

Yes. It was result of an unexpected expense or the onetime expense in the fourth quarter and it was for two reasons altogether resulting in about $2.6 million of expense, one was a write-off of inventory, I can say not GLASSIA related. And then, the second reason was an unexpected shutdown of the facility, was returning from a planned maintenance and shutdown, and that took us a little longer to return. But at this time, we’ve already recovered in the middle of Q4 and we are up and running as planned. So, could you repeat the second question? I’m not sure I remember it.

Unidentified Analyst

Analyst

Yes, sure. No problem. So, I asked that what can you -- what can we expect profitability wise in 2017? You’ve talked about being profitable, earlier in the call, but can you give some color about it?

Amir London

Chief Executive Officer

So, we haven’t given specific guidance on profitability, but with $100 million sales and the majority of the growth from the 77 this year or the 70 last year coming from GLASSIA, which represent 50% gross margin, you can calculate the impact of that on our bottom line. With that said, we expect to be profitable and cash positive in 2017.

Operator

Operator

It appears there are no further questions at this time. I would like to turn the conference back to our presenters for any additional or closing remarks.

Amir London

Chief Executive Officer

Thank you very much. In closing, we are extremely pleased with our financial performance, patent development progress and operational achievements in 2016. We continue to focus strong revenue growth in 2017 as well as moving to a position of profitability. We also expect to achieve further meaningful progress in our various clinics and regulatory development related, value-creating milestones in 2017. Kamada enters 2017 in an extremely strong operating position, and we remain focused on and committed to growing our business and enhancing shareholder value. Thank you for joining us today on our call. And we look forward to providing you with further update on our progress throughout the year. Enjoy the rest of your day. Thank you very much.

Operator

Operator

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