Kamada's CEO Discusses Q2 2013 Results - Earnings Call Transcript

Aug. 2.13 | About: Kamada Ltd (KMDA)

Kamada Ltd. (NASDAQ:KMDA)

Q2 2013 Results - Earnings Call Transcript

August 1, 2013 10:00 AM ET

Executives

Anne Marie Fields - Investor Relations, LHA

David Tsur - Chief Executive Officer

Gil Efron - Chief Financial Officer

Analysts

Adnan Butt - RBC Capital Market

David Lewis - Morgan Stanley

Raj Denhoy - Jefferies

David Ferreiro - Oppenheimer & Co.

Adnan Butt - RBC Capital Markets

Operator

Welcome to the Kamada Ltd. Second quarter earnings conference call. At this time, all participants are in a listen-only mode following management’s prepared remarks, we'll hold a Q&A session. (Operator Instructions)

As a reminder, this conference is being recorded August 1, 2013. I would now like to turn the conference over to Ann Marie Fields. Please go ahead madam.

Ann Marie Fields

Thank you, Sarah. Good morning. This is Anne Marie Fields with LHA. Thank you all for participating in today's call. Joining me from Kamada are David Tsur, Chief Executive Officer and Gil Efron, Chief Financial Officer.

Before the opening of trading on NASDAQ this morning Kamada announced financial results for the second quarter ended June 30, 2013. 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 U.S. Securities and Exchange Commission including without limitation the company's forms F1 and 6K which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statement.

Furthermore the content of this conference call contains time sensitive information that is accurate only as of the date of the live broadcast, August 1, 2013. Kamada undertakes no obligation to revise of 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 David Tsur. David?

David Tsur

Thank you, Ann Marie and good morning and thank you for joining us. I'd like to extend a particular welcome this morning to our listeners and (inaudible) the United States. Kamada Limited achieved (inaudible) quarter is a highlights including our successful IPO on the NASDAQ, as well as the expansion of our U.S. strategic distribution agreement with Baxter.

Our U.S. IPO significantly strengthened our balance sheet and gives us the platform for (inaudible) Kamada's levels. It provides us the capital to expand and accelerate our pharmaceutical development programs and puts us in a stronger position in any potential licensing or partnership discussions or negotiations.

We also achieved 17% revenue growth and strong EBITDA of over $4 million, magnificent progress, advancing our clinical trials, fortifying our patent portfolio and receive GMP compliance certification for Israel.

But before I go in to greater detail on the business, let me turn over to Gil Efron who will provide you with more financial detail on the global. So Gil remarks, I will provide a brief business update. And we then will we call for you for questions. Gil please?

Gil Efron

Thank you, David and good morning everyone. As reported in our press release, we made solid progress in the second quarter. We are pleased with this performance and look forward to delivering ongoing topline growth and profitability while continuing to make prudent investments in our clinical development pipeline and manufacturing processes.

Let's turn to review of our results. Total revenue for the second quarter 2013 increased 17% to $16.1 million, with proprietary product revenue mainly attributed to the $4.5 million funds achieved under the agreement with Baxter, partially offset by expected declines from the distributed product.

Revenue from Proprietary Products segment increased 70% to $11.9 million and revenue from the distributed product declined 37% to $4.2 million compared to the same quarter last year. For the first half of 2013, proprietary products revenue was $20 million up slightly from $19.2 million for the same period in 2012.

Revenue in the Distribution segment declined 37% to $8.8 million. As previously reported due to the timing of orders from Baxter we expect a [steady] product revenue to be much lower in the second half of the year, which is reflected in the [guidance] we provided in April for $54 million revenues from our Proprietary Products segment for the entire year of 2013.

Given today’s financial report this implies that the $4 million in the second half of 2013 which we believe would be [worked] to the fourth quarter. Turning to the rest of the P&L, R&D expenses in the second quarter of 2013 of $2.6 million up were largely in line with the $2.7 million in the second quarter of 2012.

And were down from $3.7 million in the first quarter of this year as accepted. (inaudible) 2013 R&D expenses were $6.3 million compared to $6.2 million a year ago. SG&A expenses in the second quarter of 2013 was $3.2 million increased from $1.6 million in the prior year and included a one-time management compensation payment of $1.4 million associated with the successful US IPO.

SG&A for the first half of 2013 increased to $12.9 million from $4 million in 2012. Gross profit for the second quarter of 2013 rose to $7.4 million from $3.3 million a year ago while gross margin expanded to 46% from 24% in the second quarter of 2012. Gross margin expansion is due to milestone revenues under the technology transfer agreement with Baxter.

Gross profit for the first half of 2013 rose to $11.6 million from $8.9 million and gross margin expanded to 40% from 27% in the comparable year period. We expect gross margin expansion in the second half of the year with increase in Proprietary Products segment.

In the second quarter of 2013 the company reported operating income of $1.6 million and this compares with an operating loss of $1.2 million for the second quarter of 2012. Operating income for the first six months of 2013 was $360,000 compared with an operating loss of [$720,000] a year ago.

Net income for the second quarter of 2013 was $2,000, $0.03 per diluted share and this compares with the net loss of (inaudible) or 0.08 per share. Adjusted EBITDA for the second quarter of 2013 was $4.2 million compared with [$6 million] adjusted EBITDA for the same quarter last year.

The net loss for the six months ended June 2013 narrowed to $1.1 million or $0.04 per share from a net loss of $0.7 million or $0.10 per share.

Looking now to the balance sheet. We significantly strengthened our balance sheet with net proceeds from our U.S. IPO of $53 million consequently at the end of the second quarter, we have cash and cash equivalents and short-term investment of $82.6 million up from $33.8 million as of December 31, 2012.

During the quarter, we used $3.8 million in cash flow operation and invested $1.5 million in CapEx mainly related to our new logistic infrastructure, which we expect to launch this year. (inaudible) when strengthened balance sheet, we are in good position to invest in several (inaudible) which will provide (inaudible) robust product portfolio of to (inaudible) with significant market opportunity while maintaining our focus on building long-term profitability.

With that [quarter] overview, let me now turn the call back to David.

David Tsur

Thanks for the review, Gil. We continue to successfully implement our strategic plan which includes driving growth in our Proprietary Products segment, (inaudible) while advancing the development of our clinical pipeline especially late stage (inaudible) AAT products in Europe.

With this in mind, we are particularly pleased to announce an extension of our U.S strategic agreement with Baxter under which minimum revenues, from 2010 through 2016 will increase to $165 million from $110 million previously estimated.

The agreement also extends our production of Glassia for Baxter’s distribution through '16, pushing transition to royalty payments for Glassia produced by Baxter until 2017. Until that time, we will continue to produce Glassia for distribution by Baxter, which we expect will result in higher profitability for Kamada in 2015 and 2016. As Gil mentioned Baxter ordered timeline a strong increase in the second half of the year.

Moving to a review of our clinical pipeline, and as [regulatory report] that n track to complete the European pivotal, multi-center Phase 2/3 clinical trial of our inhaled Alpha-1 in European in parallel.

We are making progress with plans for a Phase 2/3 clinical trial in Israel to treat patients newly diagnosed with type 1 diabetes with our Alpha-D1-AAT, our iv (inaudible) administration, we plan to start an advanced clinical trial by the end of the year and aim to prove efficacy Alpha-1 to hold the progression of the disease, and to maintain the ability of the pancreas to produce insulin.

We are also in advance discussion to include additional trial sites out of Israel which would substantially expand the scope of this study. We look forward to updating you as we finalize these plans.

During the second quarter, (inaudible) clinical data was published in peer-reviewed journal that highlighted the effects Alpha-1 in xenograft transplantation model and demonstrated the potential role of Alpha-1 in the early stages of Type-1 diabetes. This data supported results from the previous Phase 1/2 study in (inaudible) patients is newly diagnosed type 1 diabetes, which showed our AAT therapeutic had high safety and tolerability profile with an encouraging sign of efficacy including improving metabolic control and beta-cells [function] 12 to 16 months on diagnosis.

It indicated Alpha-1 maybe effective on beta cells better service leading to a addressable halt disease progression re-modulation of the autoimmune attack. This is an exciting opportunity for Kamada and we look forward to advancing this high-potential therapeutic.

We also are evaluating additional indications for our Alpha-1 and we'll elaborate on those plans as we make progress.

And let me now address our manufacturing, in order to meet expected growth in Alpha-1 product demand, we designed and implemented enhancements to our manufacturing processes to significantly improve capacity. We filed a request for approval of these enhancements with the U.S. FDA and intend to provide requested additional data during the second half of 2013.

We expect the FDA to approve these improvements in the first half of 2014. In the meantime we are distributing finished goods produced by the existing approved process as planned. Our 2013 revenue forecast does not assume U.S. approval of the improved manufacturing process.

We recently announced the Israeli Ministry of Health completed a GMP audit of our manufacturing facility in Beit Kama. The audit was performed as part of their routine evaluation of our manufacturing process and concluded that we comply with the GMP requirements. This audit also qualifies as an audit by the European Union.

In closing, we have made great progress on product sales, advancing clinical trials enhancing, manufacturing and strengthening our financial position. We have an exceptionally exciting company and remain on track to achieve sales (inaudible) in the coming months and look forward to a strong second half of the year.

And now operator please open the call for questions, while we await your questions. I would like note that now that we are listed and traded on the NASDAQ, we are committed to maintaining strong presence in the [U.S.] investors.

In addition to number of investment conferences we (inaudible) will be in the U.S. monthly to meet with investors. We hope you will join us at one of these conferences, operator, so we are ready for the first question.

Question-and-answer session

Operator

(Operator Instructions) Our first question is from Adnan Butt with RBC Capital Market. Please go ahead with your question.

Adnan Butt - RBC Capital Market

Good morning, everyone. Thanks for taking my question. It's about revenue guidance. So when the company says revenue should be second half weighted, should we expect them to be higher in the third quarter, fourth quarter or are there going to be more fourth quarter weighted?

Gil Efron

As I said before, we bridge revenues in the second half would be weighted more towards the fourth quarter.

Adnan Butt - RBC Capital Market

Okay. And if I can ask a question on manufacturing capacity, could you remind us what it is currently, what will it be once the FDA approves it. And then finally what is Baxter bringing online?

And then finally in terms of Baxter's, of the Baxter agreement, assuming the European approval for inhaled AAT, is this sufficient capacity to supply both markets?

David Tsur

Our capacity is the manufacturing side is fully dedicated to Alpha-1 by IV auto registration with the (inaudible) to treat patients in the range of 1,600 and then we still the cost of statement is between $80,000 and $100,000 per patient per year. If by inhaled this maybe four-times the number of patients and maybe the number of patients fees by inhaled would be 5,000 to 6,000 patients in which the capacity is fully dedicated to the inhaled. We can expand capacity.

At the same time, [Basra] building will complete on time their facility to use for their own geography which is U.S., Canada, New Zealand and Australia, the capacity which is much bigger multiple times our capacity, their production distribution wise to provide also their territory. We do have long term supply agreements with paste supplier (inaudible) more than two suppliers to support our existing and future demand and we believe that if and when needed we can sign additional long-term supply agreements for the paste to support our phase.

Adnan Butt - RBC Capital Market

And just one pipeline question. The ongoing Phase II, III study for inhaled AAT, was there FDA feedback in terms of deciding those end points and what are the end points for the -- and U.S. study that's going to be enrolling?

David Tsur

Yes. With regard to the Phase II trial in the U.S., the primary end point for this trial will be the (inaudible) and of course secondary will be Phase II (inaudible). We did have discussions with the FDA while approving the Phase II trial in the U.S. while approving the IND and then we believe the big difference also on prior discussions that we had with the FDA is the way we earn. The skin trial is designed together with the results from (inaudible) trial and we will be able to apply for marketing (inaudible) in the U.S. (inaudible).

Operator

Your next question comes from the line of David Lewis with Morgan Stanley.

David Lewis - Morgan Stanley

Gil, thanks for the commentary on the pacing of the third and the fourth quarter. I apologize if I missed it. Revenue expectations for 2013, can you provide us with your outlook or range?

Gil Efron

We guided the 2013, $74 million total, of which we expect $54 million to be in the proprietary product segment. We achieved $20 million in the first half and that is why $34 million for the second half of the year. And as we said before, we expect that to be weighted towards the fourth quarter.

David Lewis - Morgan Stanley

Okay, very helpful. Then regarding the FDA communication on manufacturing timing, can you give us anymore insight in to specifically what some of the new data requests were and what gives you the confidence that the approval is likely in the first half of ‘14?

David Tsur

Thank you. We are working on preparation for some information of FDA following clarification from the FDA, we are readying information that require us more time to collect and prepare and we are confident so that we are able to get the new process approved.

David Lewis - Morgan Stanley

And Gil you had talk before that any potential delay in the FDA timing was not going to affect ’13 guidance and obviously based on your outlook, it isn’t. Are there any implications for gross margins maybe you could, may be walk us through how would you expect gross margins in the back half of ‘13 to compare to the first half of ‘13? Thank you.

Gil Efron

In the first half of the year, when we had low revenue compared with product, this affected the gross margin and then as we get in to the second half of year, we retire revenues and that should affect the margins.

Operator

Your next question comes from the line of Raj Denhoy with Jefferies.

Raj Denhoy - Jefferies

I wonder if I could ask a little bit about your visibility into the orders from back stream, the back half of the year. Obviously we’ve got your guidance in terms of the expectation for the big step up in the second half, but I am curious the visibility you have or has back already place those orders at this point and you just expect to fill them as you move through the year?

David Tsur

Yeah, you know the major agreement is for forecast and so we have minimum order by Baxter and we are obliged as there is same in minimal order for DC next year and using another to support supply patients and based on logistic consideration about to take decision whether they need more during the first quarter, the last quarter and we expect sales to further grow during ’14 and more during ’15 and ‘16. In terms of ability to the 2013 revenue is great on orders from the (inaudible).

Raj Denhoy - Jefferies

Okay. I guess what I was just trying to get at is your level of confidence in those numbers and whether there was any risk around perhaps those orders getting pushed out further into maybe 2014, but it sounds from your commentary that those are fairly set at this point in terms of what we should expect in the back half?

David Tsur

These are same contractual orders and our forecast is based on the minimum orders, probably happened in the past that it was beyond the minimum and we are conservative and this is based on the minimum orders.

Raj Denhoy - Jefferies

Okay, that is fair. And maybe just if I could ask one question to get your opinion on or your views on, earlier there was a deal signed between (inaudible) and Aerodyne which included some capacity or some view on developing inhalable products using those two companies relative technologies. I'm curious do you have any views on the merits of that at this point or how competitive that could be to what you're developing?

David Tsur

I think that what we can say is that we are very focused, we are very advanced, we already have U.S FDA approved IND. We have fully completed Phase II for our CF. We are going to slow start late stage Phase II in the U.S. even for the CF. And for the alpha-1 for the deficiency not even close to where we standing and we believe that the device that we have (inaudible) is the best device and the best combination between our product. So we believe that we are in the good shape and file much more advances than any other company.

Operator

Your next question comes from the line of David Ferreiro with Oppenheimer.

David Ferreiro - Oppenheimer & Co.

Thank you for taking the questions. I was wondering if you could just give a little more clarity on inhale filing and approval fine lines. Especially if you expect the ongoing inhaled efficacy study to read out early in 14 and the PK studies to read out? After that file next year or are there additional manufacturing cost, is that a potentially slowing down? And also you have discussed with the FDA about the appropriateness of the breakthrough designation on inhale product?

David Tsur

No on the timeline for the inhaled, in Europe we will mostly release top line data, something during the first quarter next year hopefully beginning quarter. And then we are going to submit our file during the '14. We expect product license approval during '15 and we also expect product launch in Europe during '15.

While in the U.S. we offset the trial, the Phase 3 trial, we start toward the end of this year and we will hopefully have the result by the end of next year and hopefully and we believe based on the European data and the U.S. data and we will have to submit them to the U.S. FDA.

We believe that we will have sufficient data to apply for marketing license for and we believe that this Alpha-1 inhaled product will be launched in the U.S. during the '16. We've already shared with the U.S. FDA all our interim reports. Full interim reports with first [excellent] safety data and I think we've already mentioned in the past that you know we even provided the FDA the entire open data which we were not able to see so they feel very confident with the data and upon reviewing full interim reports, they accepted and approved our select [Phase 2 NDA] and our U.S. Phase 2 trial for the deficiency.

David Ferreiro - Oppenheimer & Co.

Okay, and then just one question on the IV market now, can you provide us any color for your partner Baxter seeing, regarding Glassia uptick in market share?

David Tsur

We cannot share due to confidentiality details. While I think that the fact that all new operations by Baxter on Glassia, patients are loyal, Baxter moving forward increasing orders and we already [committed] the tech license, their new plant with moving forward and Baxter very active in sales and marketing activity expending their more presence in the market and efforts in patients [identification], I think that we are moving forward and market share that we are very happy with.

Operator

Your next question comes from the line of Adnan Butt with RBC Capital Markets. Please go ahead with your question.

Adnan Butt - RBC Capital Markets

Just two questions on the pipeline again. First on the inhaled AAT study. You mentioned that there are patients enrolling into the expansion phase, can you give me the breakdown of patients on treatment who're enrolling versus those on placebo?

And then secondly can you say a bit about the diabetes study, what do you expect end points there to be and when will that study read out? And that's it from me, thanks.

David Tsur

On the open label extension we have now approximately 70 new patients in AAT extension study, primarily we had about 150 patients in the double-blinded trial and all these patients that completed already the trial are eligible for the open-label extension with also patients on (inaudible) double-blinded trial. In terms of the diabetes trial [endpoints] certainly probably be similar to the endpoints in the Phase 1/2 trial such as peptide level, [HBI13] level and et cetera.

Next time they are ready (inaudible) trial (inaudible).

Adnan Butt - RBC Capital Markets

And is it too early to know when we might have some data from that, Gil?

Gil Efron

I'm not sure, I understood the question?

Adnan Butt - RBC Capital Markets

When we might see some results from the diabetes study, that is it too early to estimate that, results from the diabetes study?

Gil Efron

Yeah we expect to start the study, yea, I mean it's too early in this year and then in a which has not been completed yet the design of the trial but it will take some time to enroll patients to the trial and then it’s a tricky period and (inaudible).

Gil Efron

During the similar trials, we take ultimately one year complete the trend and then when results will be very good. This is double blind placebo controlled trial, it will take some time. In the mean time I think what you can tell following the completion of the (inaudible) Phase II, II trial, we have more than 10 patients on drug under open label and I think this is very positive signs to patients on drug for almost two years and this is their own choice which is very much supported by the physicians. So this is a good sign and all our experience is now to prepare the best product design which will be hopefully initiate before the end of the year (inaudible) and we are very encouraged by additional (inaudible), but efficacy date for the new trial definitely will be not to be released we also think.

Operator

There are no further questions at this time. Please proceed with your presentation or any closing remarks. Ladies and gentlemen, that concludes your call for today. We thank you for your participation and ask that you please disconnect your lines.

David Tsur

Thank you for the questions and your continuous interest in Kamada. We have a very strong first half of 2013 and look forward to continue on this goals and trajectory in the coming quarter. We look forward to updating you again when we report our third quarter in our coming visit. Thank you very much.

Operator

Thank you. Ladies and gentlemen, you may now disconnect.

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