Operator
Operator
Welcome to the Kamada’s Third Quarter 2017 Earnings Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Paul Arndt with LifeSci Investors. Please go ahead.
Kamada Ltd. (KMDA)
Q3 2017 Earnings Call· Mon, Nov 13, 2017
$8.16
-0.49%
Same-Day
+4.30%
1 Week
+0.00%
1 Month
-3.23%
vs S&P
-6.06%
Operator
Operator
Welcome to the Kamada’s Third Quarter 2017 Earnings Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Paul Arndt with LifeSci Investors. Please go ahead.
Paul Arndt
Management
Thank you, Tracy 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 Gil Efron, Deputy CEO and Chief Financial Officer. Earlier this morning, Kamada announced financial results for the 2017 third quarter. If you have not received this news release or if you would like to be added into 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 this live broadcast, Monday November 13, 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 now like to turn the call over Amir London. Amir, please go ahead.
Amir London
Management
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 strong financial performance continued in the third quarter and contributed to our achievement of revenue growth of 26% over the first nine months of 2017. Our revenue growth continued to be driven with the growing sales of GLASSIA in the U.S. with a treatment of Alpha-1 Antitrypsin Deficiency or AATD followed by Shire as part of the strategic agreement between our companies. Gil will provide further details on our financial performance shortly but I would like to highlight a few key metrics, third, total revenues I the third quarter were $23 million comprised of $17 million from our proprietary product segments and $6 million from our distribution segment and were presented solid increase of 18% over the third quarter of 2016. On a year-to-date basis sales were up 26% to $67.1 million driven by very strong revenue growth in our proprietary product segment which include GLASSIA. From a profitability standpoint we generated positive operating and net income over the first nine months of the year specifically we generated in operating income of $1 million over the first nine months of 2017 as compared to an operating loss of 3.6 million in the corresponding period of 2016 a substantial improvement in operating income of $4.6 million. In addition we generated $0.6 million in net income over the first nine months of 2017 as compared to a net loss of $4.9 million in the corresponding period of 2016. Following our strong performance for the first nine months of 2017, we remain confident in our ability to obtain our previously stated objective of reaching $100 million in total revenue in 2017 of which $76 million to $78 million…
Gil Efron
Management
Thank you, Amir and good day everyone. To reiterate what Amir said, we continue to expect that we would generate revenues of $100 million in 2017 and we also have good visibility into 2018 revenues allowing us to guide the $160 million to $120 million of revenue in 2018. With that, let me begin my review of the third quarter financials. Total revenues was $22.9 million, an 18% increase from the $19.4 million reported in the third quarter of 2016. Revenues from the Proprietary Products segment was $17.1 million, a 13% increase from the $15 million reported in the third quarter of 2016 mainly driven from increase in GLASSIA sale. Revenues from the distributed product segment were $5.9 million, an 35% increase from the $4.3 million reported in the third quarter of 2016 mainly driven from timing of August from our customers. Gross profit was $6.4 million, up more 3% from the $6.3 million in the second quarter of 2016. Gross margins was 28% versus 32% on the prior year period. Gross profit margins were adversely affected by an increase of [indiscernible] in production in the proprietary product segment in the third quarter of 2017 compared to Q3 of 2016. Turning now to the rest of the P&L, R&D expenses in the third quarter of 2017 were $3.4 million, down 23% or $1 million on the third quarter of 2016 in which we have still ongoing studies and regulatory work for enhanced AAT in the U.S. and EU, [indiscernible]. Selling, general and administrative expenses were $3.3 million up 16% from $2.9 million in the same period of 2016. For the third quarter of 2017, we recorded an operating loss of $0.3 million compared to the $1 million operating loss recorded in the same period of 2016. Net loss was $0.2…
Operator
Operator
[Operator Instructions]. We will go to Raj Denhoy with Jefferies.
Raj Denhoy
Analyst
I wonder if I could start with the guidance for the year, you know again endorsed a $100 million for 2017, and just by the model it requires a very significant step up in the fourth quarter and I guess the question is really around your visibility into that big step up you know to something around $33 million about 35% growth to the fourth quarter, is that mostly coming from orders from Shire, is there anything being pulled forward from 2018 to the fourth quarter, maybe if you just could give us a little bit of detail around that.
Amir London
Management
We are highly confident in meeting the $100 million. If you look at the three years, typically you know the third quarter and the fourth quarter was stronger and we have those orders from Shire and we plan to supplying it. So this is our 2017 and we're not cooling from 2018, 2018 we have given our projection and this is based on the continued growth of last year and launching the rabies product in the U.S. So bottom line we're highly confident that we will be meeting the $100 million for the year.
Raj Denhoy
Analyst
And then you mentioned rabies in 2018, you talked about generating some revenues in that year, is there anything you can tell us in terms of what your expectations are and maybe also just along those lines I mean I think there is an expectation or an assumption that the market in United States for rabies is about a $100 million, you and Kedrion maybe overtime could capture half of that, is that still the assumption on how we should think about that market?
Amir London
Management
Correct. So the growth from 2017 $100 million to the projection we have given to 2018 is coming from continued growth of GLASSIA and the launch of KEDRAB in the U.S. So this $16 million to $20 million increase is a combination of both. We didn’t guide specifically the KEDRAB contribution but it's going to grow throughout the year, I can say that its already the orders for the product and the product will be launched beginning of the year. So based on what we're seeing and what we have told so it looks good, it looks very good and the assumption that you've made you know although in a course of few years we will be able to take a significant market share up to potentially 50%, we think it’s a good assumption.
Raj Denhoy
Analyst
And you're relationship with Kedrion there, are you splitting? You know how does that arrangement work in terms if you do get the $50 million say in end market sales in the United States, how will you and Kedrion split the revenues?
Amir London
Management
We did not disclose the exact details of it but what I can say is that its kind of a revenue sharing type of agreement and we will be -- both companies will be benefitting from those sales.
Raj Denhoy
Analyst
Okay, fair enough. And then just two last one I'm sorry on GLASSIA, so I don’t know if there is any more you can provide us in terms of your discussions with the FDA around starting the trial in the United States, you seemed so confident that you know latter part of 2018 you can begin that trial but is there anything you can share in terms of what the FDA is looking for, are they comfortable with the end points you selected now for that trial? I mean anything you can help us out with?
Amir London
Management
So we have finished discussing with the FDA, we have submitted a protocol we received the comments and questions we are working through those comments. We recently had further discussion with them and we're expecting the R&D to be approved in the first part of 2018 by mid-year and that we will be able to initiate the study in the second part of the year. So once we completed the discuss with the FDA we will be happy to update of course on the scope of the study and the details as you may remember when we submitted the protocol we spoke about it that we are going to put a lung function as a primary endpoint, we talked about two years study. So [indiscernible] release I believe that we have submitted in July where we highlighted the main component of the protocol we submitted we are now working through the comments received from the FDA.
Raj Denhoy
Analyst
Okay, fair enough and just one last one sorry -- there was another liquid AAT product approved in September, [indiscernible] had a product approved, I'm curious that you think that we will have an impact on the market having a second liquid product available in the United States and really how to think about that competitive launch?
Amir London
Management
The product has been approved, as far as we know it hasn’t been launched yet, but you know one should expect it will be launched in the next few months. As far as we know their approval does not include yet, a self-infusion well we have it on label so the competitive advantage of having self-infusion approved by the FDA still remains with GLASSIA and with the market growing over 10% a year as total we believe that we have significant growth ahead of us even with tougher competition because there is going to be two liquid product on the market.
Operator
Operator
We will go next to Patrick Dolezal with LifeSci Capital.
Patrick Dolezal
Analyst
I just had a couple of quick questions here. I'm curious I see AAT deficiency market and if you could provide a little addition granularity there, is it fair assumption that it is still growing at about 10%?
Amir London
Management
Yes, correct. So based on the information that we have and what has been published your assumption is correct. The market has been growing 10% a year and is growing 10% a year in total.
Patrick Dolezal
Analyst
Okay, great. And then in terms of business development I was just curious if you've any updates on that front for you all at that moment in terms of in-licensing of products things like that? Yes is there any update in terms of business development for you guys, in terms of in-licensing any new products.
Amir London
Management
Not yet. When we will have update to report we will happily do it.
Patrick Dolezal
Analyst
And I think I will ask one more just with regard to AAT and type-1 diabetes. I know that you guys kind of had made the decision in late December that you all were going to kind of stop the trial short and that obviously contributed to the powering, can you just remind us of kind of the rationale behind making that decision?
Amir London
Management
So as we announced in December 2015 two years ago we decided to turn the -- what was then planned as interim report to turn it into the final report, make it a Phase 2 study and basically to be able to expedite the result of the study so we can move forward quicker with the results so it was a business decision based on clinical information that we wanted to have it earlier and now with the data which is available to us we are happy with the decision we have made over two years ago.
Patrick Dolezal
Analyst
And then just the timing of the full data set and kind of plans for future steps for that program?
Amir London
Management
Yes, so we will have the full data set in the first quarter of the year and as mentioned during the call we're proactively looking for partners that would like to work with us on further development of that indication based on the results of the Phase 2 study.
Operator
Operator
And it appears that there are no further questions at this time. So I would like to turn the conference back to Mr. London for any additional or closing remarks.
Amir London
Management
Thank you. In summary Kamada remains in strong operating position with multiple potential value enhancing milestones upcoming based on our financial outlook we continue to expect that we will achieve revenue and financial goals for 2017 which will present strong growth versus 2016. We expect to continue growing significantly in 2018 and we are excited about the positive momentum in our business as we look forward into the fourth quarter of 2017 and into 2018. Kamada remains committed to growing our business and enhancing long term shareholder value. Thank you for joining us on today's call and we look forward to providing you with further update in our progress throughout the remainder of the year. Enjoy the rest of your day. Thank you.
Operator
Operator
This does conclude today's conference. We thank you for your participation. You may now disconnect.