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.