Kamada Ltd.

Greetings and welcome to the Common Unlimited second quarter 2022 earnings call. At this time, all participants 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, Bob Yedid. Thank you. You may begin.

Thank you, Raul. for participating in today's call. This is Bob Yedid with LifeSci Advisors. Joining me from Kamada are Amir London, Chief Executive Officer, and Jaime Orlev, Chief Financial Officer. Earlier today, Kamada announced its financial results for the three and six months ended June 30th, 2022. If you have not received this news release, please go to the investors page of the company's website at www.comeda.com. Before we begin, I'd 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 Comeda. 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 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, August 17, 2022. The company undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. Before turning the call over to management, analysts or investors can email questions for the question and answer session to my email address at the end of the press release, bob at lifebyadvisors.com. Also, you can prompt and ask questions live as usual, on any conference call at the end here. And Melissa will give those instructions. 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 start by emphasizing that six months into 2022, and based on our positive outlook for the rest of the year, we are highly encouraged by the performance of our business in 2022 and believe it is a testament to our ability to rapidly transition from our past dependency on Glacier sales to Takeda to a diversified, fully integrated commercial company and a global leader in the plasma-derived specialty market. Importantly, We are making critical progress, leveraging each of our key growth catalysts, which include the commercialization of our immovable portfolio in the U.S. market, as well as in new territories, Kedrop growth in the U.S., our distribution product in Israel, our U.S. plasma collection business, Glacier royalty income, and the recently expanded inhaled AAT clinical program. During the first half of 2022, we generated total revenues of $51.7 million, representing a 5% increase year-over-year. Our adjusted EBITDA was $4.6 million, and excluding loss associated with a labor strike, the adjusted EBITDA would have been $8 million, representing 15% margin. It's important to note that during the first six months of the year, we generated $16.4 million of operating cash flow, which supported the increase of our cash position to almost $30 million as of June 30, 2022. This increase validates our effective operations being a cash-generating business. The portfolio of the four FDA-approved immunoglobulins we acquired late last year continues to gain traction in multiple markets, and delivered strong sales and profitability for Kamada in the second quarter. As a reminder, the acquired product generated collective revenue of approximately $42 million in 2021, with over 50% gross margin. And we anticipate to significantly grow the new portfolio revenue year over year, starting already this year through proactive promotional activities in the U.S. where our newly established subsidiary, Kamada Inc., is responsible for the commercialization and direct sale of the product. We expect this marketing effort will begin to bear fruit in the U.S., commencing in the second half of this year, 2022. We are also seeing, already, meaningful sales growth from this product in the international markets, outside of North America. including the recently signed $11.4 million agreement to supply one of the four acquired FDA-approved commercial products to an undisclosed international organization operating principally in Latin America. Half of the anticipated revenues to be generated by this agreement are expected in the fourth quarter of this year, and the balance will be extended to the first half of 2023. This important supply agreement strongly validates our ability to grow the sales of our newly acquired portfolio in the international markets. We are continuing to pursue additional commercial contracts in key strategic territories and are encouraged by the significant opportunities ahead of us. This new supply agreement and our proactive selling effort through our current distribution relationship underscore Kamada's huge commitment to leveraging these new strategic assets. I should also add that we continue to expect receipt of SBA approval for the production of CytoGAM, the largest of the four acquired products at our Israeli facility during the first half of 2023 after completion of the tech transfer activities, which are now nearly complete. The ability to manufacture CytoGAM leveraging our own facility will generate higher gross margin in the future as compared to the current sourcing from a contract manufacturer. Our outlook for a stronger second half of the year is driven by multiple key factors, including anticipated continued growth of the new IDG portfolio, including sales boosted by the new value-based supply agreements, and the expected growth of CADREP sales to CADREON supporting the product's continued increase in market sales during 2022. In addition, total revenues in the second half of the year will include two full quarters of Glacier royalty income as compared to only four months in the first half of the year. Second half profitability will continue to be driven by the new IGD products and Kedrop sales, all of which generate more than 50% gross margins and glacial royalties, which are pure profits. Moreover, the now concluded labor strike will have a substantially reduced impact on the second half of the year's profitability as compared to the third half. Based on our promising outlook for the remainder of the year, we are reiterating our full-year 2022 revenue guidance of between $125 million to $135 million, with expected EBITDA margins of 12% to 15%. This guidance represents a 20% to 30% increase over 2021 revenue and more than 2.5 times 2021 EBITDA. Moreover, we continue to project revenue growth at a double-digit rate in the foreseeable years ahead. Before I continue to discuss other prospects in our business, I will mention that the recently resolved labor strike at our manufacturing facility in Israel was concluded with an execution of an eight-year collective agreement. This new agreement will be effective through the end of 2029, when certain economic terms may be renegotiated by the parties after the first four years of the agreement. Of significance, the strike had no impact on the availability of our products in the international markets. However, as previously indicated, the company's second quarter financial results were negatively impacted by this one-time loss associated with the effect of the rock stoppage at the Israeli plant, which Jaime will discuss further shortly. I would like now to discuss Kamada Plasma, our U.S.-based plasma collection company. Our early 2021 acquisition of the Plasma Collection Center represented Kamada's entry into the U.S. plasma collection market and supported our strategic goal of becoming a fully integrated specialty plasma product company. We remain focused on expanding the high-training plasma collection capacity at this center and continue to advance our plans to open additional centers in the U.S. to further enhance our supply of specialty and regular plasma. Our site selection process for a second collection center is close to finalization and will be followed by construction and startup activities in the second half of this year. We also intend to initiate the required activities for a third center by year-end. As a reminder, the planned expansion of our plasma collection capabilities is expected to enhance our IGG competitive position in various markets, boost continued revenue growth, and strengthen our supply chain. Moving on to CADRAB, our rebate in the globulin. Based on the continued moderation of the COVID pandemic in the U.S., we are highly encouraged by the product in-market sales by CADREON during the first half of the year, which grew significantly in comparison to pre-COVID pandemic sales levels. We believe this trend will continue and expect Kedrop to be an increasingly important growth driver for us over the next few years as it continues to gain market share in the $150 million U.S. market. With respect to royalty income on Glacier sales, The second quarter represented the first full quarter for which we received royalty income from Takeda around sales of this product. Royalty revenue for the second quarter was $3.7 million, meeting our expectations and prior guidance. With that, let's now turn to our recently expanded in-health AAT clinical program and the ongoing Pivotal Phase III innovative clinical trial that is evaluating the safety and efficacy of our innovative in-health AAT product for the treatment of AAT deficiency. Over the past few months, patient screening and recruitment began at traditional European sites. We are pleased with the current rate of enrollment in the study. As we said on our last call, the independent data safety monitoring board recommended in the second quarter the trial continued without modification. To date, no patients have discontinued treatment prematurely, and no drug-related serious adverse events have been reported. As a reminder, this is a unified study, and the tribe's data are expected to qualify for regulatory submissions with both the FDA and the EMA. To reiterate what we have said previously, a substantial opportunity exists for NRDA-T to be a transformational product in a market that is already over $1 billion in annual sales in the U.S. and Europe and growing steadily. And we are excited to further advance this tribe. Moving on to our Israeli distribution segment, as we have said previously, we intend to launch a portfolio of 11 biosimilar products through 2028. The products are expected to be launched upon the fifth of the Israeli regulatory approval. Collectively, these products have an annual anticipated peak sales achievable within several years of launch of more than $40 million. These anticipated revenues are in addition to our current distribution product segment sales. In closing, I'd like to highlight the successful Virtual Investment Analyst Day we hosted in June that emphasized the dramatic transformation of our business that we accomplished over just several months. If you have not already done so, I would encourage you to review this material so you can gain a deeper understanding of our anticipated growth catalysts. Moving forward, we continue to execute on our corporate strategy on all fronts and believe we have the appropriate catalyst to drive double-digit growth in the years ahead. We're excited about our prospects as Kamada is uniquely positioned for growth as a global leader in the specialty plasma industry with multiple value-creating upcoming milestones. With that, I'm going to turn the call over to Jaime for his review of our second quarter 2022 financial results. Jaime, please.

Thank you, Amir, and good day, everyone. In the second quarter of 2022, total revenues were 23.6 million dollars. For the first six months of 2022, total revenues were $51.7 million, an increase of 5% year over year. It is a solid indication to our rapid transition from prior dependency of Glacier sales to Takeda into having a more diversified operation with multiple growth drivers. The year over year growth during the first six months of 2022 was primarily driven by continued strong sales of our recently acquired IGG products. As Amir mentioned, we forecast a strong second half of the year driven by multiple factors, including continued growth of the new IGG products in the U.S., which will be driven by the ongoing marketing efforts, as well as expansion of ex-U.S. sales of these products by the Verizig supply agreement. Moreover, we expect continued growth of Kedriab to Kedrian in the second half of the year in support of the product in-market sales rule. The three months ended June 30th, 2022 represents our first full quarter receiving royalty income from Takeda on their sales of Glacia. We recognize $3.7 million of royalty income in the second quarter, which is in line with our anticipated quarterly projections. The second half of the year is expected to include two full quarters of royalty income as compared to only four months in the first half. The gross profit for the second quarter of 2022 was $7.2 million representing 31% margins compared to 9.1 million or 37% margin in the second quarter of 2021. Gross profits for the first six months of 2022 was $18.5 million, an increase of 3% year over year, and representing 36% margin. We recently resolved the labor strike at our manufacturing facility in Israel. As a result of the strike, we incurred a loss of $3.3 million, which significantly impacted our gross profits for the second quarter and first half of the year. Excluding such loss, the company's reported gross profit and gross margins would have increased year over year. It is important to note that as the labor strike ended in mid-July, we are expecting to record a subsequent portion of such loss in the third quarter. As discussed in the first quarter, the company is accounting for depreciation expenses associated with intangible assets, which were generated through the recent acquisition of the four IGG products. In the second quarter and first half of 2022, Cost of goods sold in our proprietary segment included $1.4 million and $3.7 million, respectively, of depreciation expenses associated with these assets. Second quarter and first half gross margins, excluding such intangible assets, depreciation, and the labor strike-related loss, would have been 51% and 48%, respectively. Looking ahead to the second half of 2022, the increased sales of the new IGG portfolio and CADRA would generate meaningful gross profitability, as each of these products generates more than 50% gross margin. The Globsia royalties generates pure profit, and the now concluded labor strike will have a substantially reduced impact on the second half profitability as compared to the first half. Research and development investments during the first half of the year increased compared to the prior year period, primarily due to the expansion of our ongoing physical pivotal phase three trial for inhaled AAT and is related to the opening of new clinical sites and the manufacturing of clinical supply for the study. Selling and marketing expenses for the second quarter and first half of 2022 increased as well. This increase is attributable to the establishment of our U.S. commercial operations to support the distribution and sale of the recently acquired portfolio of four FDA-approved commercial products. In addition, these costs include pre-commercial activities associated with new product launches in the Israeli distribution segment, including one of the 11 biosimilar products, which recently obtained Israeli Ministry of Health approval. As in Q1, we continue to account for financing expenses with respect to re-evaluation of the contingent consideration and long-term assumed liabilities, all of which are related to the recent acquisition. During the second quarter and first half of the year, these finance charges total $1.9 million and $3.9 million respectively. For the second quarter, we recorded a net loss of $3.9 million or $0.09 per share on a fully diluted basis. Our adjusted EBITDA was $1.3 million for the second quarter of 2022. Adjusted EBITDA for the first six months of 2022 was $4.6 million. Adjusted EBITDA for the first six months, excluding the labor strike-related loss, would have been $6.2 million, which would represent 15% margins over first half revenue. Based on our expectation of significant revenue growth and enhanced profitability in the second half of the year, we continue to expect meeting our 2022 annual guidance of revenue at the range of $125 million to $135 million and anticipate generating adjusted EBITDA at a rate of 12% to 15% of total revenue. Lastly, during the second quarter of 2022, we generated $10.9 million of operating cash flow, which is a strong testament of the company's operation cash generating capabilities. As of the end of June, the company's total cash position was approximately $30 million. 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 Anthony Petrone with Mizuho Group. Please proceed with your question.

Thanks, and congratulations on a strong quarter here in execution with the new portfolio. Amir, I want to start with the contract on Birzig, the $11.4 million in the second half to Latin America. Just a little bit more detail on that. Was that a one-time order, or should we expect that to continue into next year? And then I'll have several follow-ups. Thanks.

Hi, Anthony. Thank you for the question and for participating. So the current agreement is between the fourth quarter of this year and the first half of 2023. So we're looking at $11.4 million, which is roughly half of it will be this year, and the balance will be next year. Beyond that, we will need to wait and see if that international organization is issuing another tender. I assume that if it happens, it will happen towards the end of 2023, and we'll be covering 2024 and beyond. That organization is an organization that we have done some business in the past, and there are other tenders for other products which are part of our portfolio. So we believe that there's an opportunity to grow the business with that organization beyond just Varizeg.

That's helpful. And then Varizeg, I know, obviously, prophylactic treatment for varicella, chickenpox, and that's certainly quite different than monkeypox. But is there any chance potentially of a reformulated version of Varizeg to address monkeypox? If not, is there anything out there, you know, potentially that Kamada can participate in on that front? And then I'll have a couple more.

Okay. So as far as I know, there is no connection at all between the Varizig and the monkeypox. The increase in the demand for Varizig, and we see it not only from that organization, but we have grown ourselves for this product also in other territories. It's linked to COVID. There are papers coming especially from Latin America that show a link between the prevalence of varicella booster and COVID. So that's the main result of the main reason why we see such a significant increase demand in multiple territories. We are selling the product in the U.S., Canada, some European countries, some international territories, and now this significant new agreement with that international organization, and we anticipate to continue seeing the growth of that product beyond just that agreement with additional clients around the world. In regards to your question, we don't have in our portfolio currently something which is directly for the treatment or for the prophylactic treatment or all treatment of monkeypox. There are very few, as you may know, potential such products. This is not something which is currently in our portfolio. If there will be indication that general IVIG as a quote-unquote cocktail of inoglobulin is a relevant treatment for monkeypox. And I'm saying if, and putting a disclaimer on this right now, then, of course, we have IVIG for the Israeli market, and this can drive growth of that product.

Okay. And then, you know, second half international sales of the four IG products, Cytogam, Hepagam, as well as Verizeg. We talked about that in WinRow. Are any of these products not launched at this point, or did 2Q have active sales internationally from the entire portfolio? And then when you just think about the second half ramp internationally for the portfolio, maybe just a little bit more detail on which of the four products you expect to sort of lead the sort of uptake and which countries we should be expecting the most traction from.

Okay. So when we bought the portfolio, the business was primarily North America. I think we talked about it just after the acquisition. I believe that over 95% of sales of last year came from the U.S. and Canada. We are leveraging our international presence, our very strong international network. As we anticipated and we said right after the acquisition, we believe that we can do better with those products, and not only in the U.S. and Canada by proactively promoting the products, but also to leverage our international network to grow the business significantly in other markets. And we are very happy. that we are already seeing meaningful sales growth for those products in those markets. Varizic is just one example. But all four products are being sold in additional territories. And this is, of course, in addition to CamRub, our anti-rabidino globulin, and our legacy anti-D product, CamRub, and Glacia, which is sold outside of the U.S. as part of CamRub business, unrelated to Takeda. So, as I said, all four products are being sold in international markets. In some of the markets, it's sold as a registered product, some it's unregistered. But the business is growing, and this is becoming a more and more significant component of a growth engine catalyst of our business, and we're very happy with that.

And thanks for that, Amir. And the last one for me is on Cytogam specifically. One of the synergies the company spoke about at the time of the acquisition here was in the United States, maybe even North America as well more broadly, that that product specifically really did not have any sales and marketing push behind it. And so, you know, maybe just a little bit of an update on that initiative around Cytogam on the marketing front. Thanks.

Yes. We established our core marketing and sales team in the U.S. We hired the people. We already announced in the previous quarter that John Knight is our VP of Commercial Operations for the U.S. market. We also already hired the regional sales managers and the medical affairs team to support it, and sales and marketing activities have been initiated. We are focused on the key transportation centers in the U.S. because Cytogram, of course, is a treatment related to transportation. We're also leveraging the same sales and marketing team when we talk about HEPA-GAM because this is also for consultation centers. VARISIC is also for immunocompromised patients, so consultation centers are relevant for that. So all those activities are synergetic, and we can basically, with the same team, promote those three products in their relevant medical centers. So this is already happening, and we expect to start seeing the results of this commercial activity already in the second part of this year. And actually, in reality, we'll be seeing an increase in demand between Q1 and Q2, and we expect to see the same type of increase also during the second part of the year.

All right. Thank you very much. I'll hop back in.

Thank you. Ladies and gentlemen, I'll turn the floor back to Bob Yetted for any questions that came in through email.

Yeah, we do have a couple of questions that came in through email. And Amir, maybe you can help explain how you've reduced your dependence on Glossier sales and accomplished the sort of strategic shift that you talked about during the call and what some of the key components are.

Yes, so as I said during the call, we're very, very encouraged by the performance of the business in 2022, and we actually see, and it's happening, how we are transitioning from the part dependency we had on Glass Yourself to Paqueda to almost a new Kamada. It's a certified food-integrated company with multiple growth catalysts. So this past dependency on Glacier, which was until the middle of 2021, is gone. It's almost a new company. I think it's highly encouraging that we've made this transition in just a matter of a few months. And when we're looking on the current business and looking forward, those multiple growth engines are the new portfolio of the four FDA-approved immoglobulins. We just talked about it. Kevlar Growth in the U.S. market, which is growing significantly since the beginning of the year. Kamada Plasma, our fully-owned plasma collection company in the U.S. The growth we see and we expect to continue seeing in our distribution business in the Israeli market, including the portfolio of the 11 biosimilars that we plan to launch between this year and 2028, adding $40 million to our business. The royalty payment from Takeda, which started earlier this year, and we had the full quarter, the second quarter, of $3.7 million, which is exactly according to our expectations. And Glacier. and Kamrab, the anti-rabidine globulin, in the international markets outside of the U.S. So all those six pillars of activity created a diversified, commercial, fully integrated leader in the specialty plasma space, and it's happening. So if in the past we spoke about that it will happen in the future, that once we do this and that, this will happen. Now, a few months into 2022, I can say it's happening. It's real. It's a new Canada with a very strong prospect for continued growth moving forward.

Okay, that's helpful. The other question we had is, now that you've just talked about the U.S. sales and marketing organization you have, Does that open up additional opportunity and you have an expanded product portfolio? Does that open up additional opportunities?

to look at other Plasma derived products or other products to bring in into Kamada over time Absolutely, so as we continue building our US presence and building our sales and marketing infrastructure It's our plan to either acquire or in-license additional products, which will be a good fit with our commercial team. And this could be plasma-derived products, or this could be products that are geared towards targeting transportation centers. We will continue to focus on the business development in order to make it happen.

So the answer is yes.

Okay, great.

And the last question is one, just looking at the financials so far this year, you're running at less than half of your target for the year in terms of revenue guidance. And just, you know, help us understand, you know, you expressed some confidence in hitting your full year guidance for revenues. Help us understand some of the key factors there that give you that viewpoint.

Okay.

So, yes, looking at the second part of the year, the outlook for the second part of the year is that it's going to be a significantly stronger six months with a few catalysts that we already know them and we are in the execution phase. One is, of course, the sales of the VARISIG, execution of the VARISIG agreements. This is around 50% of this $11.4 million. This is an additional $5.5 million that we did not have in the first half, and we're going to have in the second half of the year. The new portfolio in the U.S. market are growing. This is an additional increase compared to the first half of the year. Cadrap is growing significantly, and we have female orders from Cadrion, which we are going to supply second part of the year. Second part of the year includes two full quarters of Glacier royalties versus only four months that we had in the first six months. So when you add all of this in addition to our distribution business in Israel, you basically see that we have strong distribution support to our projection for the year and that the second half will be stronger than the first half.

Great. Thank you. Those are the questions that we have from the analysts and investors. I'll turn it back to Melissa.

Thank you. Ladies and gentlemen, there are no further questions at this time. I'll turn the floor back to Mr. London for any final comments.

Thank you. Thank you very much. In closing, on behalf of the entire Commodity team, we look forward to continuing to provide clinicians and patients with an expanding portfolio of important life-saving products that we develop and manufacture and commercialize. We thank you all for your participation in today's call and for your support, and we remain firmly committed to creating long-term, sustainable shareholder value. Thank you for your participation in today's call, and 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.