Kamada Ltd.

Greetings. Welcome to Commodus Limited's fourth quarter and full year 2023 earnings conference call. At this time, all participants are in a listen-only mode. The 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 Brian Ritchie with LifeSci Advisors. Mr. Ritchie, you may now begin.

Thank you. This is Brian Ritchie with LifeSci Advisors. Thank you all for participating in today's call. Joining me from Kamada are Amir London, Chief Executive Officer, and Jaime Orlov, Chief Financial Officer. Earlier today, Kamada announced its financial results for the three and 12 months ended December 31st, 2023. 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 Kamada. 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 6, 2024. Kamada undertakes no obligation to revise or update any of the 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, Brian. My thanks also to our investors and analysts for your interest in Kamada and for participating in today's call. We are extremely pleased with the strong financial and operational momentum we experienced throughout our business during 2023, which allowed us to achieve our full year guidance. Importantly, we are well positioned for farther top and bottom line growth this year. I will begin with a high-level review of our robust financial results for full year 2023. With total revenues of $142.5 million, which represented year-over-year growth of 10%, an EBITDA of $24.1 million, an increase of 35% as compared to the 12 months ended December 31st, 2022, we achieved the top and the bottom line growth anticipated in our business during 2023. We continue to effectively leverage the growth and drivers in our business, focusing on a significant increase in CADRAB U.S. market share and the promotion of CytoGAM in the U.S. market. Looking ahead, we expect the momentum generated last year to extend through 2024, with full-year revenue and profitability to be meaningfully increased as compared to 2023. As such, we are introducing full-year 2024 revenue guidance of $156 million to $160 million and adjusted EBITDA guidance of $27 million to $30 million. The midpoint of these ranges would represent top-line and profitability growth of approximately 11% and 18% respectively, over 2023. To reiterate what we have said previously, we anticipate annual double-digit revenue and profitability growth in the foreseeable years beyond 2024 with significant upside potential and limited downside risk. Additionally, I would like to highlight our strong balance sheet. We ended the year with over $55 million in cash, and we continue to have the financial flexibility to both accelerate the growth of our existing business and pursue compelling business development opportunities, a process we are actively engaged in. In 2023, CADRAB, our anti-rabid immunoglobulin, was especially impactful, and throughout the year, we experienced a significant increase in demand for the product in the U.S. Following the recent amendment and extension of our distribution agreement with CADREON, we fully expect this trend to continue in 2024 and beyond. The substantial market share growth demonstrated by CADRAB is being driven by CADREON's extensive market coverage and robust commercial activity, as well as the FDA approval for a label expansion for the product obtained in 2021 that has differentiated it as the first and only human ribozemoglobulin available in the U.S. to be clinically studied in children. In 2023, Kamada generated approximately $32.8 million in revenues from sales of CADROB to CADREON for distribution in the U.S. market, which more than doubled our sales compared to 2022. Based on the new distribution agreement, further growth is expected in 2024. Looking ahead with CADROB, they amended and extended the distribution agreement is a tremendous milestone for Kamada. In fact, this strategic agreement with Kedron represents the largest commercial agreement since Kamada's inception. Specifically, within the first four years of the eight-year term, which began this past January, Kedron will purchase minimum quantities of Kedron with revenues to Kamada of approximately $180 million. The revised financial terms reflect Kedron's significant U.S. market share and focused continued growth throughout the eight-year term, as well as the potential expansion of Kedra, distribution by Kedrion to other territories beyond the U.S. We believe the continuation of this partnership maximizes the future growth and value potential of this important product. Moreover, this agreement must effectively exploit the U.S. business by allowing us to focus our own internal sales efforts on the commercialization of other specialized FDA-approved imoglobulin products, primarily in transplant centers. Well, CADREON continues to promote CADRAB in numerous hospitals and medical centers across the U.S. Moving on, our U.S. team established in 2022 continues to achieve steady progress in promoting our specialty IgG portfolio to physician and other healthcare practitioners through direct engagement and opportunities at medical meetings. As we have said previously, our activities promoting these important therapies, primarily Cytogem and Varizig, represent the first time in over a decade that these hyperimmune specialty products are being supported by field-based activity in the U.S. Each of these products made important contributions to our financial results in 2023, and we expect further impact this year. Importantly, in October 2023, results from an investigator-initiated five-year retrospective study consisting of 325 lung transplant patients evaluating the real-world use of cytogram in combination with antiviral agents for the prevention of CMV disease in high-risk CMV mismatched lung transplant recipients were published by Dr. Fernando Torres, the Chief the Clinical Chiefs Division of Pulmonary and Critical Care at the University of Texas Southwestern Medical Center, and the results were also presented at ID Week 2023 in Boston, Massachusetts. The high-risk mismatch patients are CMV seronegative patients receiving a lung from a seropositive donor. Dr. Torres concluded that the use of proactive multimodality CMV prophylactic consisting of antivirals and immune augmentation with CMV inoglobulin may improve outcomes among high-risk CMV mismatch lung transplant recipients. We are in the process of sharing this result with physicians and transplantation experts promoting the advantages of CytoGAM. We have already been notified that two additional studies related to the benefit of CytoGAM conducted by U.S. leading transplantation KOLs were accepted for presentation at transplantation-related medical meetings during this year. Of note, our Cytogram Scientific Advisory Board, which was established last year and consists of eight U.S.-based world-renowned thought leaders in the solid organ transplantation field, continues to evaluate new opportunities and future research and development possibilities for this important product. Moving on, looking further ahead at future catalyst, enrollment continues in the ongoing pivotal Phase III Innovate clinical trial for unhealed Alpha-1 anti-treatment therapy for the treatment of Alpha-1 deficiency. Of significance, we recently received positive feedback from the FDA in a meeting conducted with the agency. The FDA reconfirmed the overall design of our ongoing clinical program and endorsed the Data and Safety Monitoring Board unblinded positive safety assessment. The FDA also accepted our plan to conduct an open-level extension study, which is expected to be initiated in mid-2024. The agency also expressed its willingness to potentially accept a key value smaller than 0.1 alpha level in evaluating innovative for meeting the study efficacy primary endpoint for registration, which may allow for the acceleration of the program. As a result, we plan to present a revised statistical analysis plan, SAP, and study protocol for the Innovate Study and seek FDA feedback by mid-2024. As a reminder, the European Medicine Agency, the EMA, previously also reconciled the overall design of the ongoing Innovate Study and acknowledged the statistically and clinically meaningful improvements in lung function measured by FEV1 demonstrated in our prior Phase 2-3 European study. In parallel to the clinical and regulatory progress recently achieved, we also continue to have active discussions related to potential partnering of this promising late-stage product candidate. To reiterate what we have said previously, Kamada's investigational in-health AAT treatment is a non-invasive at-home treatment with an expected better ease of use and quality of life for Alpha-1 patients as compared to current IV standard of care. The inhaled product is a leading new innovative Alpha-1 treatment in advanced clinical stage, and it will present a substantial opportunity to be a transformational product in a market that is already over $1 billion in annual sales in the U.S. and the E.U. We also continue to be pleased with the progress achieved at Kamada Plasma, our U.S.-based plasma collection company. Our 2021 acquisition of a plasma collection center in New Houston, Texas 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 continue to successfully expand the hyperunion plasma collection capacity at our first center, and construction is nearly completed at our second plasma collection center located in Houston, Texas, expected to be open during the second half of this year. Finally, I would like to note our new logo launched a few weeks ago, which, if you're currently viewing the webcast, you've hopefully noticed by now. This new logo represents the transformation Kamada is going through as a leading innovative vertically integrated technology profitable specialty plasma company. With that, I'll turn the call over to Jaime for a detailed discussion of our financial results for the fourth quarter and the full year 2023. Jaime, please go ahead.