Earnings Labs

Kamada Ltd. (KMDA)

Q2 2016 Earnings Call· Tue, Aug 2, 2016

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Transcript

Operator

Operator

Good day and welcome to the Kamada Limited Second Quarter 2016 Earnings Call. Today's conference is being recorded. At this time, I would like to turn the conference over to your host, Brian Ritchie, of LifeSci Advisors. Please go ahead sir.

Brian Ritchie

Management

Thank you, and good morning. This is Brian Ritchie 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 second quarter and the six months ended June 30, 2016. If you have not received this news release or if you would like to be added to the Company's distribution list, please call [indiscernible] from LifeSci at 646-597-6992. 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, August 2, 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

Management

Thank you. And my thanks for your interest in Kamada, and for participating in today's call. We are very pleased with our financial performance in the second quarter and in the first half of 2016. We also continue to advance our key strategic initiatives aimed at expanding revenue growth and progressing our clinical program across a number of orphan indications. Importantly, the number of patients treated with Glassia in the U.S. continue to increase in the second quarter. Based on patients trend and our financial results in the second quarter and first half of 2016, we remain confident in our ability to achieve our revenue guidance $75 million to $80 million in 2016 and our goal of $100 million in 2017. While Gil will provide the detailed review of our financial results shortly, I would like to share with you a few of the highlights of our performance in the first half of 2016, and these results continue to drive our confidence in Kamada's 2016 and 2017 revenue projection. Our total revenue for the first half of 2016 increased 20% to $33.9 million over the first half of 2015 serving our proprietary product area, revenues grew approximately 46% to $23.2 million in the first six months of 2016 and compared to the first six months of 2015. What is most exciting about these results is that our revenue typically stronger in the second half of the year. For example, in 2015 and 2014 sales in the second half were approximately 49% and 45% greater than the first half of those years, respectively. In addition to the revenue growth, we see significant improvement in our profit and margin as Gil will detail later on. With that, let me now provide you with the strategic operational update. I will begin with the…

Gil Efron

Management

Thank you, Amir, and good day everyone. We are very pleased with our financial performance during the second quarter and first six months of 2016. First, let's take a look at our second quarter results, followed by our results for the six months that ended June 1, 2016. Total revenue for the second quarter of 2016 were $19.1 million, down slightly from the $19.2 for the second quarter of 2015. Revenue from the proprietary product segment was $12.1 million in the second quarter of 2016, as compared to $12.7 million in the 2015 second quarter. As a reminder, in last year's first quarter there was a delay in release of product ventures as we awaited final validation of proceeding 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. Therefore we recommended looking in comparison between the first half of 2016 with total revenues of $33.9 million compared to the first half of 2015 with revenues of $28.2 million, representing 20% growth year-over-year. Receiving stronger momentum in our proprietary segment as I will elaborate in a minute we are certainly pleased with our sales performance in this year's second quarter, and the results were in line with our expectation including Glassia sale. As I said on the first quarter call, at the end of 2015, the cumulative remaining contractual commitment from Baxalta for the year 2016 through 2018 was approximately $97 million, which lets a meaningful minimum purchase obligation in revenue stream for Kamada for the coming year. As previously reported, our 2016 order from Baxalta have already exceeded the minimum commitments of 2016 and increased again during this quarter and we expect that to continue through 2017 and 2018. As we announced in…

Operator

Operator

Thank you, sir. [Operator instructions] And we will take our first question from Raj Denhoy from Jefferies.

Raj Denhoy

Analyst

Hi, good morning.

Gil Efron

Management

Good morning, Raj.

Raj Denhoy

Analyst

I wonder if I could start with -- now that they've completed the Baxalta transaction, are you in discussions with them about their plans for Glassia in terms of insourcing manufacturing come 2018-2019 in that period?

Amir London

Management

No, not yet. The current agreement as you know is until end of 2018 and agreements has been expanded multiple times since it was initially signed 2010. We are in a close contact with Baxalta side of detail in regards to ongoing operation, ongoing productivity, ongoing supplies and I'm sure that we were talking to them in the near future in regards to their plan beyond 2018.

Raj Denhoy

Analyst

Okay. And one thing both you and they have highlighted is the recent label extension into allowing patient to self-administer Glassia in the United States. I guess I'm curious how big of an opportunity you think that is and what percentage of patients are currently self-administering or could self-administer the therapy in the United States?

Amir London

Management

We don't have specific data regarding it and it's not something that we have announced or reported. We are confident that this is another competitive advantage of the product compared to the other products on the market and we see a highly significant growth of patients on Glassia in general and will soon – this is going to support this additional growth, but I don't have specific number to provide in terms of what will be the specific contribution of enhanced infusion to those that we are seeing.

Raj Denhoy

Analyst

Okay and just my last question is just you mentioned you've gotten your 120-day questions back from the MEA or in the MAA. I'm curious if there's any more you can provide on that? You know that that it can be 2017 till you respond, given that you want to include the Phase 3 data for the United States. Is there something in particular that they're asking about that Phase 2 data will answer, or is it really just that you feel that having a more complete submission will be favorable? If there's anything more you can provide on that, it would be helpful.

Amir London

Management

Yes. I just said, we did receive the 120 question and it was part of our plan to include the data from Phase 2 study. As we have mentioned, we are planning to have top-line data in viewing this quarter and to have this full data by the end of this year and this is in-line with the timing that we expect the response to be.

Raj Denhoy

Analyst

But there isn't anything in particular? The study in United States is slightly different in terms of what it's looking at. Is it something that the Europeans are asking for relative to that data? Or is it really just more in the sake of totality to give them everything you have?

Amir London

Management

I think it's the latter at the end. The totality of the data that we have and of course in this type of indication, when you have only few studies, the more data that you have from different sources, the better the information is for the decision-maker.

Raj Denhoy

Analyst

Okay. That's all. Thank you.

Operator

Operator

[Operator instructions] It appears that we have no additional questions at this time. I would like to turn the conference back over to Amir London, CEO of Kamada for additional and closing comments.

Amir London

Management

Thank you. In closing, we are extremely pleased with our performance and achievements to date in 2016 and we look forward to further meaningfully opportunities throughout the remainder of the year. We continue to focus strong revenue growth in 2016 and 2017 with relevant meaningful clinical and regulatory progress in our various development program. Kamada remains focused on growing our business and enhancing shareholder value. Thank you for joining us today. And we look forward to providing you with further updates on our progress throughout the second half of 2016. Enjoy the rest of the day. Thank you.

Operator

Operator

And ladies and gentlemen, this does conclude today's conference. And we do thank you for participation. You may now disconnect and have a wonderful rest of your day.