Kamada Ltd.

Greetings. Welcome to the Kamada Limited First Quarter 2022 Earnings Conference Call. At this time, all participants are in ocean-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press the star zero and the telephone keypad. Please note, this conference is being recorded. I will now turn the conference over to your host, Bob Yiddish of Difestyle Advisors. You may begin.

Thank you, Shamali. This is Bob Yedid of LifeSci Advisors. Thank you all for participating in today's call. Joining me from Comida are Amir London, Chief Executive Officer, and Jaime Orlev, Chief Financial Officer. Earlier today, Comida announced its financial results for the three months ended March 31st, 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 Form 20F, and 6K, which identify specific risk 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 live broadcast Tuesday, May 17, 2022. Comida undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. If you would like to ask questions, please feel free to register for the Q&A session live at the end of the call, or feel free to email me, Bob Yeted, Bob at LifeSciAdvisors.com. With that said, it's my pleasure to turn the call over to Amir Lundin, CEO. Amir?

Thank you both. My thanks also to our investors and analysts for your interest in Kamada and for participating in today's call. Our business is off to a very strong start in 2022. During the first quarter of the year, we have effectively executed on our corporate strategy and continue advancing toward becoming a fully integrated global leader in the plasma-derived specialty market. Our performance during recent months is a strong testimonial of comrade's ability to concurrently execute on multiple fronts, developing and advancing our key growth catalysts. Those catalysts include commercialization of our IGG portfolio in the U.S. market, as well as in new territories, Kedra growth in the U.S., the Israeli distribution activity, our U.S. plasma collection business, the last year royalty income, which started in March, and the inhaled AAT clinical program, which is expanding. Moreover, during the first quarter, we generated $5.5 million of operating cash flow that supported the increase of our cash position to a total of $22 million. Importantly, the first quarter represented the first full calendar quarter commercializing the portfolio of the four FDA-approved immunoglobulins we acquired late last year. I'm pleased to report that these four products delivered solid initial sales and profitability for Kamada, meeting our plans and expectations. As a reminder, the acquired product generated collective revenues exceeding $40 million in 2021, with over 50% gross margins. And we anticipate to strongly grow the new portfolio revenues year over year through proactive promotional activities in the U.S., where our newly established subsidiary, Kamada Inc., is responsible for the commercialization and direct sales of the products. Our recently appointed Vice President of U.S. Commercial Operations, Joe Knight, has begun building out our team with multiple senior staff members. all of them experienced sales and marketing professionals with established relationships with relevant U.S. healthcare providers. We intend to actively promote these compelling products to hospitals and physicians throughout the U.S., mainly focusing on transplantation centers. We also intend to leverage our existing strong international distribution network to grow product revenue in new territories. I'm very happy to report today that sales of the products have already been initiated during the first quarter in few additional new countries, mainly in the Middle East. I should also add that we continue to expect receipt of FDA approval for the production of Cytoderm, the largest of the four required products, at our Israeli facility during the first half of 2023 after completion of the tech transfer activities which are currently at an advanced stage. Now, let's turn to the performance of our overall business in the first quarter of 2022. We generated total revenues of $28.1 million, representing strong 13% growth over the first quarter of 2021. We also achieved gross profit of $11.3 million and gross margins of 40% in the first quarter. as compared to 36% in the prior year period. This increase in our profitability was mainly driven by the four new IGG portfolio products, which generated gross margins of over 50%. Based on a strong start to 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 2.5x over 2021 EBITDA. Moreover, we continue to project revenue growth at a double-digit rate in the foreseeable years ahead. I would now like to discuss the recently established Kamada Plasma. our U.S.-based plasma collection company. You will recall our early 2021 acquisition of a plasma collection center in Texas that specializes in the collection of hyperionium plasma used for the manufacturing of one of our specialty products. This acquisition represented common entry into the U.S. plasma collection market and supported our strategic goal of becoming a fully integrated specialty plasma company. We remain focused on expanding the high-terrain plasma collection capacity to 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. In fact, we are already in the process of selecting the site location for a second collection center to be followed by construction and startup activities later this year. We are also planning 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 IDG competitive position in various markets, support continued revenue growth, and strengthen our supply chain. Moving on to CADROG, our anti-rabies IDG. Based on the recent moderation of the COVID pandemic in the U.S., We are encouraged by the product in-market sales by Cadrion during the first quarter, which has grown significantly in comparison to the pre-COVID pandemic sales level, and we believe the trend will continue. We expect Cadrub 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. You will recall that the FDA approved a label expansion for the product late last year, which differentiated CADRAB as the first and only human rabies hemoglobulin available in the U.S. to be clinically studied in children and confirm the safety and effectiveness of its use in the pediatric population. Moreover, we are also expanding sales of the product in additional important international markets, such as in Canada, Australia, and Latin America. As for Lasya, in March, Takeda initiated sales of the product from its own production, generating royalty income to Kamada. Royalty for March was $1.4 million, meeting our expected monthly rate. Turning to our in-health AET clinical program. The moderation of the COVID pandemic allows us to expand our ongoing pivotal Phase III Innovate clinical trial that evaluates the safety and efficacy over innovative in-health AAP products for the treatment of AAP deficiency to new European sites. Most recently, patient screening and recruitment began at three new sites in three European countries. In the coming weeks, three additional sites are expected to be initiated in three other European countries. Moreover, the Independent Data Safety Monitoring Board, the DSMB, recently recommended that the trial continue without modification. To date, no patients have discontinued treatment prematurely, and no drug-related serious adverse events have been reported. Additionally, to date, nine patients have already completed the full two-year treatment period. Importantly, this is a unified study, and the trial's data are expected to qualify for regulatory submissions with both the FDA and the EMA. A substantial opportunity exists for Inherit AAT 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're excited to further advance this strike. Moving to other commercial activities. In our Israel distribution segment, we plan to launch a portfolio of 11 biosimilar products between this year 2022 and 2028. The products are expected to be launched upon receipt 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 segment sales. We look forward to the launch of the first of these biochemical products later this year. In closing, We continue to execute on our corporate strategy on all fronts, and we believe that we have the appropriate catalyst to drive double-digit growth in the years ahead. We're excited about our future prospects. Kamada is uniquely positioned for growth as a global leader in the specialty plasma industry with multiple value-creating upcoming catalysts. With that, I now turn the call over to Jaime for his review of the first quarter 2022 financial results. Jaime, please.