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Kamada Ltd. (KMDA)

Q4 2017 Earnings Call· Wed, Feb 7, 2018

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Transcript

Operator

Operator

Good day and welcome to the Kamada Fourth Quarter and Fiscal Year and 2017 Financial Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Paul Arndt with LifeSci Advisors. Please go ahead sir.

Paul Arndt

Management

Thank you, Lisa 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 Chaime Orlev, Chief Financial Officer. Earlier this morning, Kamada announced financial results for the fourth quarter and full year 2017. If you have not received this news release or if you would like to be added to 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 the live broadcast, Wednesday, February 7, 2018. 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.

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 financial performance for full year 2017 was strong and we achieved total revenue growth of 33% compared to 2016. Our revenue growth continued to be driven by higher sales of GLASSIA in the US for the treatment of Alpha-1 Antitrypsin Deficiency. Last year Kamada's proprietary drug which we manufacture and is from - Shire in the US is part of a strategic agreement between our Company. Kamada total revenue in 2017 were $102.8 million comprised of $79.5 million from our proprietary product segments which includes GLASSIA and $23.3 million from our Distributed Products segment. Importantly, this result exceeded our previously provided guidance of $100 million in total revenue for 2017. I should also point out that we closed 2017 on a very strong note as we recorded significant revenue growth of 47% in the fourth quarter versus the corresponding period of 2016. 2017 revenues was Kamada's highest annual revenues when the company was founded. From a stability standpoint, we reported positive operating and net income for full year 2017. Specifically, we generated operating income of $7.4 million as compared to an operating loss of $5.5 million for the full year 2016 a substantial improvement of $12.9 million. In addition, we recorded $6.9 million in net income that's compared to a net loss of $6.7 million in 2016 an improvement of $13.6 million. Also our gross profit grew 50% year-over-year and our overall gross margin improved to 31% from 28% with the proprietary product growth margin improving to 35% from 33% last year. Looking ahead from a top line perspective in 2018, we continue to forecast total revenues within the range of $116 million to $120…

Chaime Orlev

Management

Thank you Amir and good day, everyone. To reiterate Amir's earlier statement from a financial standpoint. 2017 was a strong year for Kamada. We exceeded our revenue guidance achieved profitability and are well positioned for future growth. With that, let me begin my financial review by discussing the fourth quarter financial results. Total revenue for the fourth quarter was $35.7 million, a 47% increase from the $24.3 million reported in the fourth quarter of 2016. Revenue from the proprietary product segment were $29 million a robust 64% increase from the $17.7 million reported in the fourth quarter of 2016. Mainly driven by an increase in GLASSIA sales. Revenues from the distributed product segment were $6.7 million a 2% increase from the $6.6 million reported in the fourth quarter of 2016. Gross profit was $11.6 million up a substantial 148% from the $4.7 million recorded in the fourth quarter of 2016. Gross margin improved significantly to 33% from 19% in the prior year period due mainly to a significant increase in sales over GLASSIA. Net income for the quarter was $6.3 million or profit of $0.16 per diluted share compared to net loss of $1.8 million or loss of $0.05 per diluted share in the fourth quarter of 2016. Moving onto the results for the 12 months ended December 31, 2017. The total revenue were $102.8 million which exceeded our guidance for the year and represented 33% increase from the $77.5 million reported for the full year 2016. Proprietary product segments generated $79.5 million of revenue, a substantial 42% increase from the $56 million generated for full year 2016. Again driven mainly by increased sales of GLASSIA. Gross profit for the proprietary products segment were $28.2 million a significant 55% increase from the $18.2 million reported in full year 2016. Gross…

Operator

Operator

[Operator Instructions] we'll go first to Keay Nakae of Chardan Capital Markets.

Keay Nakae

Analyst

Couple of questions. With respect to GLASSIA. What do you estimate GLASSIA's market share in the US for AATD as of this point?

Amir London

Management

Data about market share is a public data or data which resides with Shire. We're not publishing the specific data. What I can say that based on public information that we have, Shire in total for the AAT franchise meaning our product and their legacy product is approximately 20% of the market, 20% to 25% of the market. GLASSIA is growing. We're adding more and more patient on treatment and you see it in our growth of overall GLASSIA sales to Shire in the US.

Keay Nakae

Analyst

Okay, with respect to the operating expense in 2018. Just wondering if you can give us a sense of what R&D spending might look like relative to the $12 million that you did in 2017.

Amir London

Management

For 2017 R&D investment were lower than what we've experienced in previous year primarily due to the delay in moving forward with the next inhaled study. If you'd like to have kind of benchmark or reference I think you should go back and see what were investment in R&D was in previous years 2016, 2015 and we are planning to be along the same lines of investment in terms of dollar amount, not percentage but dollar amount.

Keay Nakae

Analyst

Okay and with the commencement of the Phase 3, should we think about more that R&D spending happening in the back half of the year relative to the front half of the year?

Amir London

Management

We expect that the actual R&D or [indiscernible] investment will primarily be start in 2019 - for the inhaled clinical trial. So the plan is to obtain the IND approval by mid-year to prepare for this study, to initiate the study before the end of the year which we don't expect significant inhaled investment this year, but the actual investment will start next year.

Keay Nakae

Analyst

Okay, thanks that's helpful. All right, that's all I have.

Operator

Operator

We'll go next to Anthony Petrone of Jefferies.

Unidentified Analyst

Analyst

Good morning, this Catherine in for, Anthony Petrone. I have two quick questions and then a follow-up. First, could you please talk about the market opportunity for IV GLASSIA in treating lung transplant projection patients? And could you also provide more details around the next steps in the clinical development and timing for market plan? Thank you.

Amir London

Management

Okay, currently the number of lung transplanted patients in the US is approximately 2,000 patients per year and a similar amount in Europe. So we're looking at total population of approximately 4,000 patients. Currently there is no specific treatment for those patients, standard-of-care. As you know on steroids and [indiscernible] and the current treatment of the dosing and the study we're doing is equivalent to approximately 250 grams of AAT which is similar to the AAT deficiency treatment. But I'm using the numbers of the AAT deficiency reimbursement which are around $100,000 per patients. It's translating to an annual market opportunity of around $400 million.

Unidentified Analyst

Analyst

Great. Thank you. And could you also provide an update on Shire order trend for GLASSIA and provide us with the next step for inhalable GLASSIA studies?

Amir London

Management

Yes. So in inhaled as I mentioned we're in active discussions with FDA and we expect an IND approval by mid-year so we can initiate the study, the next study which will be a pivotal study for registration in the US and for resubmission in Europe by end of the year. But this was a timeline to initiate the study, we expect the study to last between four to five years and soon after that assuming successful study to launch the product in both territories.

Unidentified Analyst

Analyst

Great and one last one if you would allow me. Could you please recap the timeline for GLASSIA tech and money factored and transfer to Shire and give us an update, if any?

Amir London

Management

Yes as we described in our update. The current agreement in terms of supply extends until end of 2020 reminding all listeners that this agreement in terms of supply phase has been extended already four times previously by back Baxalta and Shire in [indiscernible] 2010. So this is information we currently have and if and when we have, additional information we'll be happy to share it with the public. The current agreement in terms of supply until end of 2020 one may feel that start in 2021, Shire will take over manufacturing.

Unidentified Analyst

Analyst

Great. Thank you and congratulations on the good quarter.

Operator

Operator

[Operator Instructions] we'll go next to Patrick Dolezal of LifeSci Capital.

Patrick Dolezal

Analyst

So the first one here. I was just curious, if you could give us a little more color on the margins for KamRAB in the US market?

Amir London

Management

Yes, so we've not provided specific input stability guidance. So for the product, but what we've said in the past and I will lead to that, that this is going to be highly profitable product from Kamada. We can sell the product in ex-US, rest of the world markets and for many years and prices in the US are 5x compared with the prices in the countries we've been active so far. We're definitely looking for highly profitable product. The other market which we're currently targeting as a result of the FDA approval including our announcement from two months ago results to winning in a contract with undisclosed international organization and also is the higher margin [indiscernible] markets. So all in all, this product is going to generate a high margin for Kamada.

Patrick Dolezal

Analyst

Great. Okay. And then I was also curious if you could provide any guidance on the timing updates on Phase 3 trial design for inhaled AAT.

Amir London

Management

Yes, so we expect an IND approval by mid-year, which will the timing after we finalize the plan and the protocol and the path forward with FDA to share it with the public. We feel it's premature right now to share our discussions once they're finalized, we'll be happy to do that. So we should wait patiently until middle of the year.

Patrick Dolezal

Analyst

Okay, thank you.

Operator

Operator

At this time, we have no further questions. I would like to turn the call back over to Amir London for any additional or closing comments.

Amir London

Management

Thank you. In summary, Kamada concluded 2017 extremely well positioned for further success in 2018 and beyond. As I emphasize, GLASSIA is a major growth project in the area of AAT deficiency with attractive levels of guaranteed sales from our partner Shire through 2020. Kamada will enjoy substantial royalty streams on GLASSIA currently estimated to commence in 2021, which would continue for period of 20-year until 2040. We're in advance discussion with FDA in respect to continuing our inhaled AAT program and if approved, we expect to initiate pivotal Phase 3 trial of inhaled AAT in the second half of 2018. We have a valuable clinical pipeline focused on IV AAT including GvHD, lung transplant and type-1 diabetes. We also have a strong balance sheet with $43 million of cash at the end of 2017 which provide us with the financial resources needed to continue to grow our business. And finally, we expect multiple value enhancing milestones expected this year and anticipate 13% to 17% [indiscernible] revenue growth. We remain excited about the positive momentum in our business and look forward to 2018. In closing, Kamada remains committed to growing our business and enhancing long-term shareholder value. Thank you all for joining us today on the call and we look forward to providing you with further updates on the progress throughout the year. Thank you very much.

Operator

Operator

That does conclude our conference for today. We thank you for your participation. You may now disconnect.