Earnings Labs

Kamada Ltd. (KMDA)

Q1 2016 Earnings Call· Mon, May 9, 2016

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Transcript

Operator

Operator

Welcome to the Kamada 2016 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following management’s prepared remarks, we will hold a Q&A session. [Operator Instructions] As a reminder, this conference is being recorded May 9th, 2016. I would now like to turn the conference over to Anne Marie Fields. Please go ahead Ma’am.

Anne Marie Fields

Analyst

Thank you. Good morning. This is Anne Marie Fields with LHA. 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 first quarter. If you have not received this news 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 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 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 the live broadcast, May 9th, 2016. 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 to Amir London. Amir?

Amir London

Analyst

Thank you, Ann Marie. And my thanks to our listeners for your interest in Kamada and for participating in today’s call. Throughout the first quarter, we made meaningful progress with strategic initiatives to grow our revenues and advance our clinical programs across a number of orphan indications. We continued to build our core Protein Plasma business, led by significant increases in the number of patients treated with Glassia in the U.S. through Baxalta which gives us confidence in our ability to achieve our revenue goals for 2016 and 2017. We are pleased with the consistently increasing number of patients treated by Glassia as recently reflected by achieving a sales milestone and expect this growth to continue in the coming years. We also made important progress with our clinical programs which I will review in a moment. But first, let me turn the call over to Gil Efron for a review of our financial performance for the first quarter of 2016. Gil?

Gil Efron

Analyst

Thank you, Amir, and good day, everyone. We are very pleased with our financial performance during the first quarter. We are also pleased to be introducing 2016 revenue guidance that underscores the progress we are making with our plasma-derived therapeutics. Our expectation for 2016 also gives us confidence in our ability to achieve our goal to reach $100 million in revenue in 2017, which includes mainly growth in Proprietary Product segment. Now let’s turn to our financial – first quarter 2016 financial results. Total revenues for the first quarter of 2016 of $14.8 million, compared with $8.9 million for the first quarter of 2015. Revenues from the Proprietary Product segment were $11.1 million, up from $3.3 million in the 2015 first quarter. You may recall, that during last year’s first quarter, there was a delay in the release of product batches as we awaited final validation of a filling process. That process was validated in April 2015 and the revenues delayed from the first quarter of 2015 were realized in the second quarter of 2015. First quarter 2016 revenues were inline with our expectations including our Glassia sales. As of the end of 2015, the cumulative remaining commitment from Baxalta for the year 2016 through 2018, was approximately $97 million, leaving a meaningful minimum purchase obligation in revenue stream for the coming years. 2016 order for Baxalta already exceeds the minimum commitment for 2016 and we expect that to continue through 2017 and 2019. For the first quarter of 2016, Distributed Products revenue was $3.7 million, compared with $5.7 million in the same quarter of 2015, with a decline largely due to timing of orders. Gross profit for the first quarter of 2016 was $4.8 million, compared with $0.4 million for the first quarter of 2015. Gross margin increased to…

Amir London

Analyst

Thank you, Gil for that financial overview. Let me begin my review with our strategic partnership with Baxalta. This partnership continues to strengthen as we work together to grow Glassia revenues and to expand its use into other orphan indications. As you certainly remember, late last year, we were pleased to announce a third extension to agreement with Baxalta. Not only that this latest extension had approximately $50 million in minimum revenue commitment, but it also extends the timeframe in which Kamada will continue to manufacture the products for Baxalta. This is important because it provides efficiencies and higher gross margins for Kamada and it gives us visibility into our revenues for the coming three years. Furthermore, it underscores the growing number of AATD patients being treated with Glassia in the U.S. and validates Baxalta's confidence in its growth over the coming years. We remain confident in Glassia’s ability to continue to grow and take market share due to the unique competitive advantages it offers patients and physicians. Glassia is the only ready-to-infuse AAT product and has an enhanced infusion rate which is a meaningful difference for both patients and physicians. The AAT augmentation market is over $0.5 billion in the U.S. annually, and it’s growing by approximately 10% a year as a result of better diagnostics and disease state awareness programs underway by all three major players. Baxalta is doing a superb job leveraging Glassia’s competitive advantages, growing Glassia by much more than the industry average and gaining market share. In addition to the U.S., we are expanding our global AAT presence through registrations of products and expansion of a chosen marketing network in different countries where AATD is prevalent. During 2016, we plan to file Glassia registration in the different countries in Eastern Europe and Latin America. Let’s…

Operator

Operator

[Operator Instructions] Our first question…

Amir London

Analyst

While we are waiting for the first question, I’d like to note that we will be participating in the upcoming Jefferies Healthcare Conference taking place June 7, through 10 in New York City. For those attending the conference, would like to meet with us, please contact Anne Marie Fields at LHA at 212-838-3777. Thank you.

Operator

Operator

Our first question is from the line of Raj Denhoy with Jefferies. Please go ahead.

Raj Denhoy

Analyst

Hi, good morning. I wonder if I could, maybe, start on the guidance, particularly the $100 million guidance for 2017 that you are sticking with. I don’t think it’s was anybody the sharp step-up in revenue growth you are going to need to see in 2017 to achieve that from the guidance you’ve given here in 2016. And so the question is really around, where you’ll see that growth? Is it going to come from – partially from the Rabies approval you are expecting in 2017? Do you expect to see an acceleration in the AAT business? Just really any help around how you get comfortable with that sharp acceleration actually be helpful.

Gil Efron

Analyst

Raj, thank you for the question. As we have mentioned before, we did not assume a Rabies or inhaled revenues in the 2017 guidance. And we do see growth coming from the Proprietary Product segment and more specifically from Glassia sales. I think you have few indications for the basis for our confidence in this number and this is related to the achievement of the sales milestone very recently for sales in the U.S. For Glassia, as well as for the level or the coming orders from Baxalta for 2016, which already exceeded we are having as a minimum commitment for this year. And we believe this trend will continue through 2017 and, okay, Amir?

Amir London

Analyst

Thank you, Raj, it’s Amir. The majority of the increase will be coming from the increase in number of patients treated with Glassia in the U.S. We see this growth coming and that is the main contribution for the increase compared to 2015 and 2016.

Raj Denhoy

Analyst

Right, now, I guess, I understand that. But just, just be sure, if you look at the growth rates, right, if you – most of the growth into next year is going to come from proprietary products. That segment has to grow something, 35% to 40% assuming that Distributed Products is roughly flat, which you haven’t seen that kind of growth really ever in that product line as long as we’ve been following you guys. And so, I suppose you have better visibility into the underlying patient trends, but, again, just trying to be comfortable with the fact that you can see that level of step-up and growth, when you are out from now.

Amir London

Analyst

Correct. Yes, like I said, what you – and we talked about in the past, based on the minimum commitment that Baxalta has in the original contract with Kamada, there has minimum commitment of purchasing, and the increasing number of patients treated with Glassia in the U.S. has not been reflected in our sales to Baxalta in the last three to four years. But this increase is happening and starting this year, and in greater next year, this is going to be reflected in our sales to Baxalta. So it’s in inventory management aspects, the two of them are now changing and will be reflected in our sales will be reflected in our sales to Baxalta starting this year and continuing in greater rate next year.

Raj Denhoy

Analyst

Okay, that’s helpful and just one last one for me, just with inhaleable submission in Europe, perhaps you could just provide us with some milestones we can look forward to really timing of events that we can look to over the next several quarters and months?

Amir London

Analyst

There is a formal process that is being managed by EMA. And so, if you follow that process starting when, we announced the fact that our submission was validated. The next step for us will be with call day 120, that’s when we get the questions from EMA. And that you know, we will kick-off a process of asking us questions, providing answers, usually it takes few intervals of those question answers, and then finally, we expect in mid-2017 to get the final call from EMA.

Raj Denhoy

Analyst

Okay, that’s helpful. Thank you.

Amir London

Analyst

You are welcome.

Operator

Operator

That is all the questions we have for today. I will now turn the call over to Mr. London for any closing remarks.

Amir London

Analyst

Thank you for your continued interest in Kamada. We look forward to updating you again when we report our second quarter 2016 financial results. Have a good day.

Operator

Operator

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