Earnings Labs

Kamada Ltd. (KMDA)

Q1 2019 Earnings Call· Tue, May 14, 2019

$8.16

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Transcript

Operator

Operator

Greetings and welcome to the Kamada's First Quarter 2019 Earnings Call. [Operator Instructions] Please note this conference is being recorded. I'd now turn the conference over to your host today Mr. Bob Yedid with LifeSci Advisors. Please proceed, sir.

Bob Yedid

Analyst

Thank you and good morning. This is Bob Yedid from 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 first quarter ended March 31, 2019. If you have not received this news release or if you would like to be added to the Company's distribution list, please email me @lifesci@bob@lifesciadvisor.com or see the company's website under the Investor section. 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 future operations and 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 this live broadcast, May 14, 2019. 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, it's my pleasure now to turn the call over to Amir London, Chief Executive Officer. Amir?

Amir London

Analyst

Thank you, Bob. And thanks all to our listeners for your interest in Kamada and for participating in today's call. Let me begin by saying that we are extremely pleased with our solid start to 2019. We began the year with very strong operating performance. Total revenues in the first quarter were $26.8 million, which represented a 54% increase compared to the third quarter of 2018. This impressive result was primarily driven by increased sales of GLASSIA and KedRAB of anti-rabies IgG product. From a profitability standpoint, our gross operating and net income improved substantially year-over-year in the first quarter of 2019. In addition, we continued to maintain the substantial cash position which increased to $55.8 million of cash in short-term investment at the end of the first quarter which provide us the financial resources needed to continue executing on our business plan. Based on our strong performance in the first quarter, and our positive outlook for the remainder of the year, we are reiterating our previously provided [Indiscernible] 2019 total revenue guidance of $125 million to $130 million which represent another strong year of double-digit percentage growth over full-year 2018 total revenue. This guidance reflects continued growth in our proprietary product business, principally the growth of GLASSIA and continued growth of KedRAB in 2019. As a reminder, our GLASSIA supply agreement with Takeda which extend through the end of 2020 will be followed by an expected flow of future royalty payments for 20 years, until 2040. Before we start our clinical pipeline, I would like to highlight KedRAB which is an important driver of new time revenue growth of Kamada. You will recall that this product was launched with Kedrion, our commercial partner in the US in 2018. This launch continues to meet our expectation. As we approach the…

Chaime Orlev

Analyst

Thank you, Amir and good day, everyone. We're pleased with our robust first quarter 2019 financial performance. Once again, we delivered double-digit percentage revenue growth and our profitability metrics including adjust EBITDA, operating income and net income were all strong. With that, let me now discuss the specific financial results for the first quarter ended March 31st, 2019. The revenue was $26.8 million in the first quarter of 2019, a 54% increase from the $17.4 million recorded in the first quarter of 2018. Revenues from the proprietary product segments in the first quarter of 2019 were $20.4 million, a substantial 67% increase from the $12.2 million reported in the first quarter of 2018. Primarily driven by increased sales of both of our core products GLASSIA and KedRAB. Revenues from the distributive product segments was $66.4 million in the first quarter of 2019, a solid 23% increase from the $5.2 million recorded in the first quarter of 2018. Gross profit was $11.2 million in the first quarter of 2019, a 59% increase from the $7 million reported in the first quarter of 2018. Gross margin increased to 42% from 40% in the first quarter of 2018 due to the increase in revenue and favorable product sales mix. Net income was $4.9 million or profit of $0.12 per diluted share in the first quarter of 2019, compared to net income of $1.3 million or a profit of $0.03 per diluted share. Looking ahead from a P&L perspective, I should add that when we begin the Human Factor Study and phase 3 study for our inhaled AAT program which Amir outlined earlier, we expect that the R&D spent will increase beginning in the second quarter and continuing throughout 2019. During the first quarter of 2019, we generated positive cash flow from operation of $6.1 million which contributed to our strong financial position. As of March 31st, 2019, the company had cash, cash equivalents and short-term investments totaling $55.8 million compared to $50.6 six million at December 31st, 2019. With that I'll open up the call for questions. Operator?

Operator

Operator

[Operator Instructions] Our first question comes from Raj Denhoy with Jefferies. Please proceed with your question.

Raj Denhoy

Analyst

Hi, good morning. Wonder if maybe I could start with the results in the quarters. So the proprietary products know about, it's little about $20 million in the quarter. Very strong growth as you noted relative to last year, but if you if we think about the guidance for the year that line probably has to do something north of a $100 million or right around a $100 million which does imply the next three quarters need to improve fairly substantially off that number. And so I'm just trying to get some sense of what will drive that increase. Will it be KedRAB or will be it expected orders from Takeda for GLASSIA? Anything you can help in terms of the acceleration in the revenue over the balance of the year we should.

Amir London

Analyst

Okay, hi, Raj. Good morning. Last year we finished with $115 million in sales. And we gave the guidance of this year it will be between $125 million, $130 million. The growth comes from both KedRAB being the first year, the first full year of sales and their continuous increase in the number of patient treated on GLASSIA which adapt to our continued growth of GLASSIA sales to Takeda. So it's a combination of those products. And we had a strong first quarter which positions us very well to be able to meet that guidance. And we are encouraged and optimistic for the rest of the year.

Raj Denhoy

Analyst

Okay. Maybe I could follow up on KedRAB because you mentioned it's $150 million market roughly in the United States. Any sense of where you and Kedrion share stands at this point and your expectations for continuing to increase that share position over the course of the year?

Amir London

Analyst

Yes. So we did disclose in 2018 with strong or modest fortune, we sold $12 million of KedRAB to Kedrion. We would not disclose what then split between us and Kedrion in terms of market revenue in market sales but you can assume that Kedrion has their significant share above the $12 million of KedRAB sold them. And that would be the market share. Now if you're looking at our next two three years outlook, we expect to - and we believe that we can reach 30 to 20 maybe after 50% market share basically competing with one strong player and that 30%, 40%, 50% of $150 million will be shared between Kamada and Kedrion.

Raj Denhoy

Analyst

That's helpful. Maybe just I could segue way the trial, the GLASSIA trial, so good progress on that front, but I guess I'm curious about the timing of the trial at this point. You expect to complete the human factor study by the end of the year and then begin the phase 3 study, I'm curious your thoughts on the timing to enroll the 250 patients. I think in times past we talked about that trial being ATT naive patients and so how long do you think it'll take to identify those 250 patients and enroll them. And how much of a deterrent do you think it'll be that the control arm is a placebo. So those patients aren't receiving any ATT at all.

Amir London

Analyst

Okay. So as I just said, for the Human Factor Study which has estimated requirement already started and we expect to be able to initiate the phase 3 study with third patient being the second part of the year meaning before the end of the year of course. We estimate based on past experience and discussion we had in KOL as well as specific sites that we plan to engage in to the study that the overall equipment of the 250 patients will take up to 24 months meaning up to two years. And is going to be - the site are going to be open in the US and selected European countries. Placebo could be a challenge but with experience we have and the fact that there are multiple European countries where IV treatment is not available currently, we believe that we will be able to successfully to include the patients. There is a lot of excitement amongst physicians and patients on the fact that being held to - is going to be back in clinic first week, we recently came from the Alpha One Foundation Global meeting which is biannual conference of all key stakeholders in the Alpha One deficiency field. And there was a lot of excitement around we have. Recently there was a survey among Alpha One patients and the vast majorities of them are expecting and are preferring the health treatment over IV. So we believe the market is there. The product is there and we need to prove it in successfully way we study.

Operator

Operator

There are no further questions in queue at this time. I would like to turn the call back over to Mr. London for closing comment.

Amir London

Analyst

Thank you. In summary, we are pleased with how business is performing across all segments. Our revenue growth came in strong, our profitability metrics are improving and we have a very strong balance sheet. Kamada will find path so we have I think very promising and have the potential for the importance source of value creation for our shareholders, along with other typical significant pipeline of opportunities ahead of us. Therefore, we firmly believe Kamada will be well positioned for continued success. Thank you all for joining us on today's call. And we look forward to providing you with further update on our progress throughout the rest of the year. Thank you.

Operator

Operator

This does conclude teleconference. You may disconnect your line at this. And thank you thank you for your participation.