Kamada Ltd.

Greetings. Welcome to Commodore Limited's second quarter 2023 earnings conference call. At this time, all participants are in listen-only mode. Any question and answer session will follow the formal presentation. If anyone 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, the LifeSci Advisors. Brian, you may now begin.

Thank you, and 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 his financial results for the three- and six-month-ended June 30, 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, August 16, 2023. AMADA 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's 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. I'm pleased to report a strong start to 2023 continued in the second quarter, both financially and operationally, and we are well positioned to achieve our 2023 full year guidance, which I will discuss momentarily. I will begin with a high-level review of our strong financial results for the first six months of 2023. With total revenues of $68.2 million, which represented year-over-year growth of 32%, an adjusted EBITDA of $9.9 million, an increase of 24% as compared to the first half of 2022, we achieved the top and bottom-line growth anticipated in our business in the first six months of the year. Importantly, we continue to effectively leverage our multiple growth drivers, including a significant increase in Caterpillars for further distribution in the U.S., the portfolio of four FDA-approved hemoglobulins acquired in late 2021, Phytogram, Hepagram, Varizig, and Winro, and our Israeli distribution business. Looking ahead, we expect the momentum for the first half of the year to extend to the remainder of 2023. with annual profitability to be further meaningfully enhanced as compared to last year. As such, we are reiterating our full-year 2023 revenue guidance of $138 million to $146 million and adjusted EBITDA of $22 million to $26 million. The midpoint of the range represents profitability growth of approximately 35% over 2022. To reiterate what we have said previously, beyond 2023, we continue to anticipate annual double-digit revenue and profitability growth in the foreseeable years ahead of us, with significant upside potential and limited downside risk. As previously reported, in May, we entered into a securities purchase agreement with CIMI, the leading private equity firm in Israel, and a large existing shareholder of Kamada, under which Fini will purchase an additional $60 million of our ordinary shares in a private placement. An extraordinary general meeting of the shareholders of the company to approve the private placement will be held later this month on August 29, 2023. As a reminder, under the terms of the purchase agreement, Kamada will issue an aggregate of approximately $10 12.6 million ordinary shares to Finney at a price of $4.75 per share, which represents the average closing price of the company's shares on NASDAQ during the 20 trading days prior to the date of the purchase agreement. Upon the closing of the transaction, Finney is expected to beneficially own approximately 38% of Kamada's outstanding ordinary shares and will become the controlling shareholder of the company within the meaning of the Israeli company's law. This strategic investment, if approved, will provide us with financial flexibility, allowing us to accelerate the growth of our existing business and pursue compelling business development opportunities. The process that we have initiated is expected to be further ramped up upon receipt of the shareholder approval and closing of the private placement. With respect to our existing business, let's begin with Kedrop, our anti-rabbit in the global. We were pleased to announce last month that Kedrion has exercised its option to extend our distribution agreement for Kedrop in the U.S. through March 2026. Moreover, we remain in active discussion with Kedrion to potentially further expand the scope of our collaboration. During 2022, we generated approximately 16,000 million in revenue from CEDR to CADREON for further distribution in the U.S. market, which is estimated to be a total of $150 million annually. During the first six months of this year, we experienced a significant increase in demand for the product in the U.S., and we anticipate even further momentum in the second half of the year that includes the summer months. Also, as a reminder, this product continues to generate more than 50% growth margins for Kamada. Additionally, our U.S. team established during 2022 continues to achieve good progress in promoting our specialty in the global portfolio to physicians and other healthcare practitioners through direct engagement and opportunities at medical meetings. As we have said previously, our activities promoting these important therapies, primarily cytosine and viruses, We present 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 remain encouraged by the positive feedback received from key U.S. physicians who are seeking to publish new clinical data related to our products while conducting educational symposiums that we believe will have a positive impact on understanding of these medicines, contributing to continued growth in demand. Importantly, in May of this year, we announced FDA approval of our application to manufacture CytoGum at our Israeli facility after completing the technology transfer of the product manufacturing from its prior manufacturer, CSL Bearing. I'm happy to report today that we recently obtained a similar approval from Health Canada, thereby successfully completing the tech transfer of this product. This approval ensures continuous supply of CytoGum to the U.S. and the Canadian markets, with no interruption, and we expect to initiate sale of the product manufactured in our Israel facility early in the first quarter of this year. Moving on, looking further ahead as future catalysts, we continue to be pleased with the progress made at Kamada Plasma, our U.S.-based plasma collection company. Our 2021 acquisition of the 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. We are successfully expanding the hyperunion plasma collection capacity at our first center, and we plan on opening our second collection center in Houston, Texas, in early 2024. On the development side, enrollment is ramping in our ongoing pivotal phase three in-office clinical trial for the inhaled alpha-1 antitreatment therapy for the treatment of alpha-1 deficiency. And the study has enrolled 62 patients through the end of July, which is approximately 30% of the overall required enrollment to the study. I'm happy to update today that we've recently received positive scientific advice from the European Medicine Agency, the EMA, that we consume the overall design of the ongoing study and acknowledge the statistically and clinically meaningful improvement in lung function measured by SED1 demonstrated in our previous Phase II-III European study. As a reminder, the results of the previous study served as the basis for the design and the selection of the primary endpoint of our current pivotal Phase III study. We are planning to complete our discussion with the FDA regarding the study progress by end of this year. As a reminder, Kamadad's investigation in health AAP 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 the current IEV standard of care. The inhaled product is the 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 Europe. With that, I now turn the call over to Jaime for a detailed discussion of our second quarter and first half 2023 financial results. Jaime, please go ahead.