Kamada Ltd.

Welcome to Commodity Limited fourth quarter full year 2022 earnings conference call. At this time, all participants are in listen only mode. Question and answer session will follow the formal presentation. If anyone today should require operator assistance during the conference, please press star zero from your telephone keypad. Please note this conference is being recorded. At this time, I'll turn the conference over to Troy Williams, the Lifestyle Advisor. Troy, you may now begin.

Thank you, Rob. This is Troy Williams with Lifesize Advisors, and thank you all for participating in today's call. 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 12 months into December 31st, 2022. If you have not received this news release, please go to the investors page of the company's website at www.kamada.com. 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 the model. 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 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, March 15th, 2023. Kamata 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 is my pleasure to turn the call over to Amir London, CEO. Amir?

Thank you, Troy. My thanks also to our investors and analysts for your interest in Kamada and for participating in today's call. The recently completed 2022 year was a transformational period for Kamada as we embarked on a new and exciting chapter in the company's evolution. Most importantly, we have now completed our rapid transition from our historical dependence on glass herself to Takeda to a diversified, fully integrated specialty plasma company with six FDA-approved proprietary products and strong commercial capabilities in the U.S. market, as well as global sales footprint in over 30 countries. The success of this strategic shift is supported by our impressive full-year 2022 financial results, which met our annual guidance. Specifically, we achieved total revenues of $129 million and EBITDA of approximately $18 million, representing margins of 14%. Our strong performance in 2022 represented revenue growth of over 25% as compared to 2021, and a 3x increase in EBITDA. Moreover, we generated record operating cash flow of $28.6 million during 2022, supporting the increase in our cash position to $34 million as of December 31, 2022, which is nearly double what it was at the end of 2021. Looking ahead, we expect the momentum from 2022 to extend throughout 2023, with profitability to further meaningfully enhance as compared to last year. As such, we are introducing full-year 2023 revenue guidance of $138 million to $146 million, and EBITDA of $22 million to $26 million. The midpoint of that range would represent profitability growth of approximately 35% over 2022. Our impressive results in 2022 and positive outlook for this year are the consequence of our ability to leverage multiple growth drivers, including the portfolio of four FDA-approved IGGs that we acquired in late 2021, ketchup sales in the U.S., Galatia royalties received from Takeda, other proprietary products sold in international markets, and our thriving Israeli distribution business. This significant catalyst, which I will discuss further momentarily, are driving our annual double-digit revenue growth with significant upside potential and limited downside risk. Most importantly, The acquisition completed in November 21 of the four FDA-approved IGGs consisting of CytoGem, HepaGem, Virizic, and Winro, following a thorough search for the ideal assets for Kamada, was a critical strategic and synergetic advancement for the company. I'm thrilled to report that the full year 2022 revenues of the acquired product increased by 24% as compared to full year 2021, and are generating growth margins of over 50%. During 2022, as part of the establishment of our direct presence in the U.S. market, we deployed a team of U.S.-based experienced cells and medical affairs professionals who have rapidly established operation in these key markets. The U.S. cells team is making good progress in promoting our portfolio of specialty plasma products to physicians, and other healthcare practitioners through direct engagement and opportunities at medical conventions. The medical affairs team is working to educate physicians while addressing the scientific and clinical inquiries, including participating in major medical conferences in the U.S. As a reminder, our activities promoting these important therapies represent the first time in over a decade that these hyperimmune specialty products have been supported by field-based activity in the U.S. market. We are encouraged by the continued positive feedback received from key U.S. physicians who are seeking to publish new clinical data related to our portfolio while conducting educational symposiums that we believe will have a positive impact on the understanding of these products, contributing to continued growth in demand. We expect to begin seeing the impact of our activity later this year. We are also leveraging our existing strong international distribution network to grow product revenues in new territories, primarily in Latin America and the Middle East. Our achievements with these key products in 2022, including winning a new $11.4 million procurement agreement for Varizy from an international organization operating principally in Latin America, and securing a $22 million extension of a Canadian supply tender. Both of these agreements will contribute to our results this year. Of course, we are continuing to pursue additional commercial contracts in key strategic territories and are highly encouraged for the significant opportunities ahead of us in 2023 and beyond. These supply agreements and our proactive selling efforts through our long-standing distribution relationships underscore Canada's firm commitment to leveraging these new strategic assets. Of the four acquired products, the largest is CytoGum, indicated for the prophylaxis of CMV disease associated with solid organ transplantation. This proprietary and unique therapy is the only FDA-approved IgG product for its indication. We recently submitted an application to the FDA to manufacture CytoGum at our plant in Israel and expect to receive regulatory approval by mid-year. The anticipated FDA approval will mark the successful conclusion of the technology transfer process for Cypogram from the previous manufacturer, TSL Bearing. The ability to manufacture this product at our facility will positively impact our plant utilization and efficiency. Let's move on to CADRAB, our Revit immunoglobulin. In the past year, CADRAB marketed in the U.S. by CADREON continued to gain significant market share in the U.S. market, which is estimated to be $150 million annually. CADRAB's commercial team successfully leveraged the FDA approval obtained in 2021 for a label expansion for the product that helped differentiate it as the first and only human-ready immunoglobulin available in the U.S. to be clinically studied in children. we anticipate that several of the products will continue to grow significantly over the next few years. Also, to reiterate what we have said previously, I should highlight that this product also generates more than 50% growth margin for Kamada. Moving on, during 2022, as planned, we began receiving lesser royalty payments from Takeda. For full year 2022, we generated royalty income of $12.2 million, and we expect to receive payments in the range of $10 million to $20 million annually through 2040, which will help us grow our profitability and cash position. In addition, we continue to grow sales of the product in international markets to our local partners. Now let's look a little further ahead at future catalysts. I will begin with Kamada Plasma, our U.S.-based plasma collection company. Our early 2021 acquisition of a plasma collection center in New Houston, Texas represented Canada's entry into the U.S. plasma collection market and supported our strategic goal of becoming a fully integrated specialty plasma product company. Last year, we expanded the hyperunion plasma collection capacity at our first center and are currently advancing our plan to open additional centers in the U.S. to further enhance our supply of specialty plasma and regular plasma. Let's now turn to our ongoing Pivotal Phase III Innovate clinical trial that is evaluating the safety and efficacy of our innovative in-health AAT product for the treatment of AAT deficiency. We remain very excited about the potential of this promising product candidate that's shown to be highly effective in delivering AAT directly into the patient's lungs. A substantial opportunity exists for NLDAT to be a transformational product in a market that is already over $1 billion in annual sales in the U.S. and the EU. We are currently conducting the Innovate Clinical Trial, a randomized and double-blind placebo-controlled pivotal phase 3 study. During 2022, we began to accelerate trial recruitment with seven clinical sites now open and enrolling patients. In addition, the Independent Data Safety Monitoring Board, the DSMD, recommended in November 2022 the study continue without modification for the fourth time since the trial was initiated. To date, 50 patients have been enrolled for treatment, including 19 patients who have already completed the two-year study treatment period at the first trial site in Leiden, the Netherlands. Importantly, No drug-related serious adverse events were reported to date, and the high-level patient adherence to the treatment is encouraging. Moreover, based on encouraging safety observed to date, the study inclusion criteria was revised to also include patients with severe airflow limitation. Throughout 2023, we intend to continue expediting trial recruitment, and to meet with the FDA and the European Medicine Agency, EMA, to discuss study progress and potential opportunities to shorten the regulatory pathway. In our Israel distribution segment, we are leveraging our expertise and strong presence in the Israeli market to register, market, and distribute more than 25 products that are developed and manufactured by our international partners. In recent years, we have significantly grown our pipeline of distributed products, In 2023, we anticipate continuing to launch new therapies across multiple medical specialties. An area of strategic focus in this business is the planned distribution of a portfolio of 11 biosimilar products expected to be launched upon receipt of Israeli regulatory approval through 2028, with overall annual anticipated peak sales within several years of launch of more than $40 million. Included in this portfolio are eight products to a distribution agreement with Alvotec, a global leader in the development and manufacturing of biosimilar drugs. To summarize, 2022 was a year of significant progress for Kamada, during which we achieved rapid financial improvement by leveraging multiple robust value-creating catalysts. And we are well-positioned to further substantial revenue and profitability growth in 2023 and the years beyond, with limited downside risk and substantial upside potential as a global leader in the specialty plasma industry. Importantly, looking past 2023, based on our multiple catalysts, we continue to project annual double-digit growth in revenues and profitability in the foreseeable years ahead of us. With that, I now turn the call over to Jaime. Jaime, please.