Earnings Labs

Kamada Ltd. (KMDA)

Q3 2016 Earnings Call· Thu, Nov 10, 2016

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Transcript

Operator

Operator

Good day, and welcome to the Kamada Limited Third Quarter 2016 Earnings Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Bob Yedid. Please go ahead sir.

Bob Yedid

Management

Thank you, Jim, good morning. This is Bob Yedid 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 third quarter and the nine months ended September 30, 2016. If you have not received this news or if you like to be added the company's distribution list please call Paul Arndt from LifeSci at area code 646-597-6992 or go to the company's Investor Relations Web site. 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 this live broadcast, November 10, 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'd like to turn the call over to Amir London. Amir?

Amir London

Management

Thank you, Bob, and thanks to our listeners for your interest in Kamada and for participating in today's call. We are very pleased with our financial performance in the third quarter and in the first nine months 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 growth in our proprietary product revenue is driven by the growth in our sales of Glassia, which is consistent with the growth in the number of patients treated with Glassia in the U.S, which we reported for 2014-2015, to be continued as well during this year. This growth resulted in the increasing orders from our strategic partner in the U.S. share [ph]. Based on patient trends and our strong financial results in the third quarter and first nine months of 2016, we are very confident in our ability to achieve our revenue guidance of $75 million to $80 million in 2016, and reiterate our goal of $100 million of total revenues in 2017. While Gil will provide a detailed review of our financial results shortly, I'd like to share with you a few of the highlights of our performance for the third quarter of 2016, as these results continue to drive our confidence in Kamada's 2016 and 2017 revenue projections. Our total revenues for the third quarter 2016 was $19.4 million, a solid increase of 21% from the third quarter of 2015. Sales in our proprietary product grew a robust 57% to $15 [ph] million in the third quarter of 2016 as compared to prior year period. What is most exciting about this result is we expect the strong revenue momentum to continue into the fourth quarter of 2016, which is typically our strongest…

Gil Efron

Management

Thank you, Amir, and good day everyone. We are very pleased about our strong financial performance during the third quarter and first nine months of 2016. First, let's take a look at our third quarter results followed by our results for the nine months ended September 30, 2016. Total revenue for the third quarter of 2016 were $19.4 million, up a solid 21% from the $16.1 million for the third quarter of last year. Revenues from the proprietary product segment was $15 million in the third quarter of 2016, up a robust 57% as compared to the $9.6 million in the 2016 third quarter. As a new stuff, we have an increase in Glassia sales this year as a result of increase in number of patients treated by Glassia in the last two years as well as since the beginning of this year. For the third quarter of 2016, distributed products revenue was $4.3 million compared with $6.5 million in the same quarter of 2015 and the decrease is due to the timing of orders and sales during the year and the different product mix. Gross profit for the third quarter of 2016 was $6.3 million, up 69% compared with $3.7 million for the third quarter of 2016. Gross margin increased to 32.4% from 23.1% in Q3 2015, primarily as a result of the increase in profitability in the Proprietary Products from 28% to 37% and the higher mix of the Proprietary Products revenue [indiscernible] distributed products revenue. Looking now to the rest of the P&L. R&D expense in the third quarter of 2016 were $4.4 million, down slightly from $5 million in the third quarter of 2015. Selling, general and administrative expenses in the third quarter of 2016 were $2.9 million, an increase of 8% from a year ago.…

Operator

Operator

Certainly. [Operator Instructions] And we'll take our first question from Raj Denhoy from Jefferies.

Raj Denhoy

Analyst

Hi, good morning guys.

Amir London

Management

Good morning, Raj.

Raj Denhoy

Analyst

I wonder if I could start with the Phase 2 data that you recently announced the long data. As you noted, quite compelling in terms of looking at the levels of AAT in the lung. I'm just curious how you think the regulators will view that data, again given that it is not clinical, but really looking at other surrogates versus the Phase 2/3 data that ultimately failed on its primary endpoint. How do we think about those two things in balances as you move to get that product reviewed in Europe?

Amir London

Management

Yes, Raj, thank you for the question. We believe the regulator will look on the significant advantage of the results that we saw in the Phase 2 study that may have a link to the European study explaining the results that we did see in the European study. And then this will help us designing the next step in the U.S. towards an additional clinical study and for the inhaled AAT.

Raj Denhoy

Analyst

Okay, but I guess the question is really, we're trying to gauge the prospects for that review now in Europe. And it is now really kind of on the doorstep of it in 2017. Have you been able to gauge any initial reactions to the Phase 2 data or is it really just sort of too new at this point?

Amir London

Management

Yes, I was planning to take those results, include them in the response to the day 120 questions. So we are planning to respond by the beginning of the year, in January 2017, including this data.

Raj Denhoy

Analyst

Okay, fair enough. And then just for a second question, just on the extension of the deal, the arrangement with Shire now, the 2020. The question is really around why Shire is extending that? Our understanding was, and I think as you always articulated that they would eventually transfer manufacturing over to their own facility. And the thought was that by 2018 that facility they were building in Europe would be up and running and they would transfer the product there, and start to pay you royalty. Now that's been pushed out to 2020. Are they still planning on building a facility? Do you have any input into what Shire is doing at this point?

Amir London

Management

Hi, Raj, thanks for the question, it's Amir. This is of course an internal Shire decision [indiscernible] now it's moving to Shire, so we are not fully aware of all the internal criteria for making such a decision. What we know for sure is that we have the capacity to continue supporting the significant increase in number of patients as treated there with Glassia in the U.S. And compared to the regional agreement when it was first signed, we have a much more capacity to support the increase. So we believe it has to do with the fact that there are internal capacity and a plan therefore their own plan is being pushed. [Indiscernible] continue supplying their needed quantities and we haven't missed a single order in six years and we will continue to supply them as much as needed and if needed we can grow our capacity even further.

Raj Denhoy

Analyst

Okay, that's helpful. Thank you.

Operator

Operator

[Operator Instructions] And at the time, it appears there are no further questions. That will conclude our question-and-answer session then. I would like to turn it back to our CEO for additional or closing remarks.

Amir London

Management

Thank you. In closing, we are extremely pleased with our performance and operational and financial achievements to date in 2016. We continue to focus strong revenue growth in 2016 and 2017 as well as 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 on the call. And we look forward to providing you with further updates on our progress throughout the balance of 2016. For investors and equity research analysts who would like to meet with us, we will be participating in the LifeSci Corporate Access Event in Samsung Peace Forum on January 9-11, 2017, in conjunction with the JPMorgan Healthcare Conference. If you would like to meet with us, please email bobyedid@lifesci, the contact information is on the press release. Enjoy the rest of your day. Thank you.

Operator

Operator

And that will conclude today's conference. And we do thank you for your participation.