Kamada Ltd.

Greetings and welcome to the Commodad Limited fourth quarter and fiscal year 2020 earnings call. At this time, all lines are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Bob Yedid with LifeSci Advisors. Thank you. You may begin.

Thank you, Melissa, and welcome to everyone joining the call. This is Bob Yedid from Lifestyle Advisors. Thank you for participating in today's call. And joining me are from Comida, Amir London, Chief Executive Officer, and Jaime Orlev, Chief Financial Officer. Early this morning, Comida announced financial results for the three and 12 months ended December 31, 2020. If you have not received this press release, please go to the investors page of the company's website. Before we begin, I'd like to caution the 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 Comida. I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation, the company's forms 20F and 6K, which identify specific factors which 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, February 10th, 2021. Comida 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 to turn the call over to Amir London, CEO. Amir.

Thank you, Bob. My thanks also to our investors and analysts for your interest in Kamada and for participating in today's call. Let me begin by highlighting our strong overall financial results for full year 2020. Despite the significant headwinds caused by the global coronavirus crisis, we overcame meaningful operational challenges and met our key financial targets. For full year 2020, we recorded total revenues of $133.2 million, which is in line with our guidance of $132 million to $137 million. And the 5% increase over the $127.2 million in total revenue generated in 2019. In a year which was greatly impacted by COVID-19, we are pleased with this result and believe they indicate the fundamental strength of our business, which, as I will discuss shortly, will drive Commerzat growth prospects. Commerzat's core focus is on driving profitable growth from our current commercial activities and manufacturing expertise. We intend to expand our proprietary plasma-derived product business by maximizing the market potential of our existing proprietary product portfolio, broadening our distributed product portfolio, enhancing our current manufacturing capabilities, and evolving into a vertically integrated plasma-derived company. In addition, we continue to develop our pipeline, primarily focusing on the Pivotal Phase III Innovate Clinical Trial of Inhered AAT for the Treatment of Alpha-1 Antitrypsin Deficiency and on Exploring New Strategic Business Development Opportunities funded by our strong cash position of nearly $110 million as of December 31st, 2020. Moreover, we plan to leverage our FDA-approved IGG platform technology as a strategic business line with the ability to respond to future potential pandemic situations. Let me now elaborate on three of our recent important achievements executing on these key initiatives. I will start with our recently announced acquisition of the privately held Blood and Plasma Research, or BNPR, in Beaumont, Texas, and the establishment of our own subsidiary, Kamada Plasma, which represents our entry into the U.S. plasma collection market and drives us toward our strategic goal of becoming a fully integrated specialty plasma company. This facility specializes in collection of hyperimmune plasma used by Kamada to manufacture our NTD products, which are distributed in international markets. By investing in BNPR facility and leveraging its FDA license, to open additional centers in the U.S., we plan to significantly expand our hyperimmune plasma collection capacity. This planned expansion is expected to improve our IGG competitive position in various markets. We are extremely excited about the future opportunities this acquisition will provide for our business. Secondly, in regards to our COVID-19 IGG product, We believe this program clearly demonstrates our ability to quickly respond to emerging pandemic situations. We recently initiated the supply of this investigational product to the Israeli MOH for the treatment of COVID-19 patients in Israel. As a reminder, the initial order is sufficient to treat approximately 500 hospitalized patients and is expected to generate approximately $3.5 million in revenue for Ramadan. Importantly, the Israeli MOH has initiated a multi-center clinical study in which our product is being administrated. In parallel, we are ramping up our COVID-19 IgG manufacturing production, utilizing plasma collected in the U.S. by our partner, Kejiro Biopharma. This manufacturing increase will support potential additional demand from the Israeli MOH and possibly other international markets. We previously reported the completion of enrollment and positive insurance results from our Phase 1-2 open-label, single-arm, multi-center clinical trial. We are currently assembling the final study report, and we plan to publish it before the end of the current quarter. Together with Cadreon, our partner for the development program, we continue to evaluate the best suitable plan for the U.S. and or the EU COVID-19 IgG clinical program, and we will advance our development upon the conclusion of this review. While we are, of course, pleased that the rollout of COVID-19 vaccines has commenced in some countries, we remain confident that there will be a continued market demand for plasma-derived IgG as a treatment for COVID-19-infected patients. Thirdly, we continue to expand our Israel-based distribution segment by augmenting our existing distributed product portfolio. specifically in the emerging area of biosimilars. As recently reported, we entered into agreements with two international pharmaceutical companies to commercialize three biosimilar product candidates in Israel. Subject to approval by EMA and also by the Israeli MOH, the three products are expected to be launched in Israel between 2022 and 2024. These three products are added to the six other biosimilar products previously licensed from Alvotec, and further positioned Kamada as a leader in the emerging biosimilar market in Israel. We estimate the potential collective maximum sale generated by the distribution of this nine biosimilar product achievable following regulatory approval and within several years to be in the range of $25 million to $35 million annually. Before I summarize, let me now turn to the current status of our INNOVATE Phase III clinical program for our propriety in health AAT for the treatment of Alpha-1 anthocyanin deficiency. As a reminder, INNOVATE is a randomized, double-blind, placebo-controlled, pivotal Phase III trial designed to assess the success and safety of in health AAT in patients with Alpha-1 deficiency and moderate lung disease. While we continue to recruit patients into the study, the COVID-19 pandemic has limited our ability to open new study sites, and it continues to slow down the rate of recruitment, which has been true for many other clinical trials. From a strategic standpoint, we continue to evaluate parting opportunities for the development and commercialization of this important strategic pipeline product. In addition to the three significant strategic initiatives described above, our new plasma collection capabilities, the rapid development and supply agreement of the COVID-19 IGG, and the expansion of our biosimilar portfolio, we are intensely focused on driving higher organic growth by, one, continuing to increase CADRA market share in the U.S., where we believe we have significant room to grow. Two, expanding the sales of Glacier in our IGG portfolio in ex-U.S. markets, including the registration and launch of the product in new territories. Three, generating royalties from Glacier, projected to be in the range of $10 to $20 million per year, commencing in 2022. And four, leveraging our plasma-derived manufacturing capabilities for the provision of contract manufacturing services, such as those of the FDA-approved and commercialized specialty IGG product, which is expected to add between $8 to $10 million in annual revenue, starting in 2023. we continue to firmly believe in the strength of our business, which consists of multiple lines of activity, which can drive significant long-term growth opportunities for Kamada. With that, I now ask Jaime to review our financial results for the fourth quarter and the full year 2020. Jaime, please.

Thank you, Amir, and good day, everyone. We believe the core drivers of our business helped deliver solid results in 2020 in the face of the global COVID-19 pandemic. In the fourth quarter, total revenues were $31.5 million compared to $32.1 million in the fourth quarter of 2019. For the full year ended December 31, 2020, total revenues were $133.2 million, up 5% from the $127.2 million for the year ended December 31, 2019. As Amir noted, this is in line with our guidance of $132 to $137 million, which we view as a significant accomplishment during a year with many COVID-19 related operational challenges. From a profitability standpoint, our gross profits for the fourth quarter of 2020 was $10.2 million, and gross margins were 33%. Down from $12.1 million, of total gross profit or 38% margin in the fourth quarter of 2019. For the year ended December 31st, 2020, our gross profit was 47.6 million and gross margins were 36% compared to 49.7 million of gross profit and 39% margin in the year ended December 31st, 2019. These results were in line with the guidance we provided at the beginning of the year of an annual decrease of three to five percentage points in proprietary product segment gross margin, primarily attributable to change in product sales mix and reduced plant utilization. Our distribution product segment margins were also negatively impacted in 2020 by a shift in product mix from 2019. Operating expenses, including research and development, sales and marketing, G&A, as well as other expenses, totaled $7.5 million in the fourth quarter of 2020 as compared to $6.6 million in the fourth quarter of 2019. For the full year, these costs totaled $28.3 million as compared to $27 million for the full year of 2019. As the case in the second and third quarters, enrollment during the fourth quarter in the company's pivotal phase three Innovate Clinical trial, which resumed in the third quarter, but at a slow pace was impacted by the ongoing COVID-19 pandemic. This again resulted in a lower than expected increase in research and development expenses in the fourth quarter. For full year 2020, research and development expenses increased 4% year over year versus our guidance of a 13 to 15% increase. Moving on. Net income was 1.6 million or 4 cents per share on a fully diluted basis in the fourth quarter of 2020 as compared to net income of 5.4 million or 13 cents per share in the fourth quarter of 2019. Net income was 17.1 million or 38 cents per share in the year end of December 31st, 2020 as compared to net income of 22.3 million or 55 cents per share in 2019. Kamada continues to operate from a position of financial strength and is generating positive cash flow from operating activities, with a total of 109.3 million in cash balances as of December 31st, 2020, as compared to 73.9 million at December 31st, 2019. As previously reported, the transition of Glacier Manufacturing to Takeda and the continued uncertainty in the operating environment created by the ongoing global COVID-19 pandemic are expected to result in reduced revenues and profitability in 2021. That concludes our prepared remarks. We will now open the call for questions. Melissa?

Thank you. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question comes from the line of Raj Dhanoy with Jefferies. Please proceed with your question.

Hi, this is Anthony for Raj. I have a couple of questions on biosimilars, and then I'll move over to plasma and COVID. On the biosimilar products, Amir, can you maybe describe to us a little bit of detail around the approval pathway? These are biosimilars. Biosimilars have several hurdles to clear, PK studies, PB studies. In some cases, there are comparative studies to prove similarity, and so I'm just wondering what the specific approval pathway for these products look like, and if any of them have an abbreviated pathway that we should expect. And then when we think about the 2022 to 2024 window as it relates to timing, how should we expect the three products to sort of evolve in terms of catalysts and approval over those three years, two years rather?

Hi, Anthony. Good morning. Thank you for the question. So basically I would like to refer to that on all nine products, the three, six that were signed with AlvoTech and then the three additional products from the other two agreements signed a few weeks ago. So in total, we are moving forward basically with this portfolio. We are relying on approvals from primarily EMA, the European authorities. So the companies that own the product will get them approved by EMA, and then the file basically goes to the Israeli Ministry of Health, which needs to approve it. Israeli Ministry of Health typically, usually approves based on EMA or U.S. approvals, so we do not foresee significant hurdles in those approvals once it's approved by the European authorities. The first product has already been submitted to the MOH here in Israel. and we expect approval and launch next year. Now, the three products, the three new products are expected to be approved between 2022 and 2024. I believe it's going to be around one product per year, and then we expect to be the first or the second biosimilar product in the Israeli market, taking a significant market share. When you add up all nine products, we expect, the sales from this portfolio to be between $25 to $35 million. I want to remind everyone that this is in addition to our existing distribution business in Israel, which is currently around $30 million per year. So that's a significant growth engine for Kamada. Profitability of those products is going to be higher than the current profitability, which is currently still primarily tendered products, which are plasma-derived. So we expect that the overall segment, our distribution segment, is going to grow significantly in terms of revenue, but also in terms of profitability over the next few years.

That's helpful. And again, the $25 million to $30 million base, I think you cut off a bit, is the underlying and distributed. $25 million to $35 million base.

Yeah, so currently if you follow our report, for example, for this, for 2020, you see approximately $30 million in the distribution segment, and this is before without the new biosimilar portfolio.

Thank you. And then the follow-ups, I'll pivot over to plasma collection. And just wondering, you know, it seems to be indications that, Following the Beaumont Center, there'll be an effort to add plasma collection. And so maybe just a little bit more details there, Aimee, on will it exclusively continue to be high titer collection? Will the focus be exclusively on high titer IGG collection for specialty products? Or will the company eventually look to expand into broader general plasma collection? And when we think about the pathway to adding collection capacity, will it be exclusively through acquisition, or will the company at some point begin to build its own plasma stars?

Thank you. Good question. So, the BMON facility, basically, our plan is to invest in maximizing the capacity collection capacity in the BMO facility and to leverage its license to open additional centers. So Kamada plans to open additional centers. Referring to the last part of your question in terms of opening centers or through acquisitions. So basically this acquisition gives us the license and opportunity now to initiate the expansion by opening additional centers. The immediate focus is on hyperimmune plasma. This will give us the ability to strategically build the company as a vertically integrated company, basically source our own plasma for our hyperimmune products. It improved our competitive profile by owning the plasma and not purchasing all of it from external suppliers. We are not ruling out the option that this will eventually evolve into also opening a regular source plasma collection, but the immediate current focus is on the IP immune for our specific specialty plasma needs.

That's helpful. A couple of follow-ups there. I'll press a bit is, you know, what is the annual collection capacity a few months today? You know, where do you expect that to trend to in terms of liters per year? You know, when you think about building out new facilities, you know, how many, how large do you envision the footprint can become over time?

So, we did not disclose the specific volumes of the B1 facility, but as I said, you know, we plan to maximize its capacity. Unlike, you know, regular plasma collection centers that there are plenty of those in the U.S. and there is a lot of kind of benchmark and standards around it and everyone in this industry knows exactly, you know, how much such a plasma collection center can collect, et cetera, et cetera. In the specialty plasma business, it's different. We would like to collect at least, you know, over the next few years, So we will become primarily almost self-sufficient in terms of growing that business and being able to supply. And as I mentioned before, having a better competitive profile with our high premium products in the international markets and be able to grow that collection business pair our specific needs as we grow our hyperimmune portfolio in the different markets.

And maybe one for Jaime on collection. Maybe just, you know, can you review what the eventual gross margin or overall margin benefit the company could expect in hyperimmune specifically by bringing collections in-house? And I'll hot-block you. Thanks again.

Yeah, so it's a good question, but it really depends on the different markets, of course, in, you know, the U.S. and, you know, the Western markets where prices are, end product prices are higher than, you know, it has one aspect in the developing countries where we participate in large tenders, highly competitive tenders, It has its effect. We did not disclose yet, you know, what the impact is going to be on our gross margins, but as you can assume, owning the plasma versus buying the plasma has a significant impact in an industry where the cost of plasma is the number one component to the cost of goods.

Thank you.

Thank you. Our next question comes from line of Kay Nakai with Charter and Capital Markets. Please proceed with your question.

Yes, good morning. For the phase three inhaled study, can you give us a sense of when you now think you'll be able to complete enrollments?

Thank you, Kai. So originally, when we put the plan together and what we have shared with the public was that we expect that enrollment will take around two years. Because of the COVID situation, we had to delay the opening of additional sites. So the actual timelines for recruitment, of course, will take longer in terms of duration. Once the COVID situation improves and the new sites, primarily in Europe, will be opened, we will be able to give a more accurate focus in terms of the timelines. In that, you know, without the COVID situation, this should have taken us two years to complete recruitment.

Okay. So... With respect to the European sites, in terms of the overall percentage of recruiting sites, the sites that are still closed would represent about what percentage?

Of the overall recruitment?

Yes.

As described in the past, you know, we were planning to open sites in Europe and the U.S., primarily in the U.S. because of the landscape of countries where there is no current IV treatment available for patients. We've done a lot of the legwork in terms of being ready to open the sites, but in countries where the country is almost under lockdown. There is no ability to effectively recruit patients. We decided not to open the sites yet. Once the situation improves and the COVID, you know, pandemic is in a different state and we decide to open the sites, we will be able to give a better forecast in terms of the timeline to complete recruitment.

Okay. So obviously that trial impacts R&D. So having just finished the full year, R&D relatively flat to 2019. So compared to the, you know, 13.6 million you spent in R&D in 2020, what should we anticipate R&D spend to look like in 2021?

We expect it to be at a similar range because we expect that the current programs that we are running, you know, will continue at the same rate. I think that's a good estimation for 2021. And once the COVID situation improves, we will be able to go back to the rate that we were anticipating for 2020, and that's a guidance that we've given in terms of planned R&D expense that eventually It was not executed because of the delay with the recruitment of in-health study.

Okay. In terms of the new plasma collection facility in Beaumont, is there also intermediate products that you can, that are collected that you can sell to others?

Yes, there is an option also to sell it to third parties. The main focus and the main priority is to collect plasma for our needs, focusing on the hyperimmune plasmas. But the answer to your question is yes. There is also different plasma products that are being sold to third-party clients.

but that's a small amount of the plasma collected, or how do we characterize that?

Correct. It's not going to have a significant impact on our overall PNL.

Okay. In terms of the COVID hyperimmune, you talked about plans to publish the results from the first study, but when should we expect some clarity on moving that product forward in clinical trials.

Okay. So there is a clinical trial which basically started. This is sponsored by the Israeli Ministry of Health. And that's a study that we provide the product and the ministry is sponsoring. The study synopsis is for hospitalized patients, similar inclusion criteria. to our Phase 1-2 study that we reported. The first cohort of the study is approximately 135 patients which are being randomized one-to-one against standard of care and convalescent plasma. It's a multisensory study in Israel. In addition to the study, other hospitals in Israel can treat patients through a named patient procedure. So basically, the treatment is available for all hospitals in Israel per the Ministry of Health procedures, and the hospitals decide if they want to treat through a clinical trial or on an inpatient basis.

Right. And how about plans for any type of U.S. clinical study?

Okay, so as I mentioned on the call, we're still evaluating together with CADRE on what is the best suitable plan for the U.S. and or Europe, and we will advance the development once we reach the conclusion of this review.

And do you expect to make that decision in the first half of this year?

Most likely, yes. The data from the Israeli study, the data from other studies that are being done abroad like the one that is being done by the NIH will support, will partially support this decision. Okay. I want to also re-emphasize what I mentioned earlier that we are ramping up the production of the product in our FDA-approved facility. using plasma collected in the US. And this manufacturing increase supports the potential additional demand that we expect from the Israel Ministry of Health and possibly other international markets.

Okay. And then just in terms of how we think about product revenue in 2021, starting with the distributed products. Again, we just finished the year with, as you referenced, you know, just slightly north of 30 million in revenue from distributed products. How should we think about that in 2021?

So, as you noticed, we did not provide yet specific guidance for 2021 due to the uncertainty in the with the covet situation in terms of the israel distribution business you should assume that the current pace will be similar we are registering and launching new products but in part to that there was some stockpiling of ivg products by the hospitals in israel in 2020 and that inventory is available for them also for 2021. In general, our overall portfolio for the Israel distribution is growing. It's not just a biosimilar product that we have been emphasizing, but we, over the last few years, every year we sign additional agreements, additional in-licensing deals. We are registering additional products for the Israeli market, and that business is steadily growing.

Okay. And in terms of the proprietary products for CADRAB or CAMRAB, how should we think about their growth prospects in 2021?

So this is, I think, part of the uncertainty regarding the COVID situation, and we will not give that, in this time, specific guidance in regard to those products. For Glacier, you are familiar with the $25 million supply that we are going to supply to Takeda this year. As a reminder, we also sell the product in other markets outside of the U.S., and this has been growing over the last few years. In regards to the other specifics, we are not giving currently yet guidance for 2021.

Okay. All right. That's all I have. Thank you.

Thank you, Kai.

Thank you. Ladies and gentlemen, that concludes our question and answer session. I'll turn the floor back to Mr. London for any final comments.

Thank you. In summary, we are proud of the strength of our business in 2020, despite the global COVID-19 pandemic. We believe that the fundamentals of our business are solid. We have multiple organic commercial growth catalysts. Our FDA approved plasma direct technology platform is a strategic asset in our ability to quickly respond to emerging pandemic situation. And we have a very strong balance sheet which can support or business development opportunities. As such, we remain highly confident in Commodore's future prospects. Thank you for joining us on today's call, and we look forward to providing you with further updates on our progress throughout 2021. We hope you all stay healthy and safe. Thank you very much.

Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.