Kamada Ltd.

Thank you for standing by. This is the conference operator. Welcome to the Kamada Limited second quarter 2020 earnings conference call. As a reminder, all participants are in listen only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star then one on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing star and zero. I would now like to turn the conference over to Troy Williams of LifeSci Advisors. Please go ahead.

Troy Williams Thank you and good morning, everyone. This is Troy Williams of LifeSci Advisors. Thank you all for participating in today's call. Joining me from Comida are Amir London, Chief Executive Officer, and Chaime Orlev, Chief Financial Officer. Earlier this morning, Comida announced financial results for the three and six months into June 30, 2020. If you have not received this news release, please go to the investor's page of the company's website at www.comida.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 Comida. 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, August 12, 2020. 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 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. I hope you all are keeping safe and healthy in these challenging times. Let me begin by discussing the significant progress we have achieved in the development of our plasma-derived immunoglobulin product, as a potential therapy for COVID-19 disease. Following our announcement in June of being the first company globally with an availability of a COVID-19 IgG product for compassionate youth treatment in Israel, earlier this week we announced initiation of a Phase 1-2 clinical study in Israel. This is an open-label, single-arm, multi-central study to assess the safety, pharmacokinetics, and pharmacodynamics of our IgG product in 12 hospitalized non-ventilated COVID-19 patients with pneumonia. Our product has also been evaluated for SARS-CoV-2 neutralization activity and the preliminary results are highly encouraging and suggest potential high neutralization titer. Lastly, we intend to further explore the potential of our IgG product to prevent COVID-19 disease in Healthy Subjects at Risk in a Separate Study. We are very excited by this meaningful progress, and we believe our product has the potential to be an effective treatment for hospitalized non-ventilated COVID-19 patients with pneumonia, and we look forward to the results of this trial later this year. As a reminder, this milestone is part of our global collaboration agreement established in April 2020 with Cadrion Biopharma for the development, manufacturing, and distribution of our IgG product as a potential treatment for COVID-19 patients. Pursuant to the collaboration between the two companies, Cadrion is responsible for the collection of COVID-19 convalescent plasma from U.S. recovered patients. Cadrion is already collecting the plasma through its plasma business unit, CAD Plasma, at 23 FDA approved centers across the United States. We intend to expand our COVID-19 clinical development program to the U.S. and plan to conduct a pre-IND meeting with the U.S. FDA during the current quarter in order to obtain FDA acceptance for our proposed clinical development program. If FDA clearance of the IND is received, Kamada and Kadrian intend to initiate the clinical program in the U.S. in early 2021. Moving on, I'd like to report that we are accelerating our commercial and business development efforts, and we are working to mitigate the effect of the planned transition of Glastonbury Manufacturing to Takeda during 2021. I am optimistic that our organic commercial growth as well as additional business development opportunities and many more. As a reminder, we anticipate revenues of approximately $65 million from sales of glasses to Takeda this year and in the range of $25 million to $50 million in 2021 based on Takeda supply needs. In addition, based on the agreement between the companies upon the initiation of sales of Galassia manufactured by Takeda, we will receive royalty payments from Takeda at a rate of 12% on net sales through August 2025 and at a rate of 6% thereafter until 2040 with a minimum of $5 million annually for each of the years from 2022 to 2040. In addition to Glacia's contribution, we expect Kedrub's revenue and U.S. market share to continue to grow. As a reminder, Kedrub U.S. market share increased from approximately 10% in 2018 to approximately 20% in 2019, and it continues to grow. In addition, we anticipate continued strong contribution from our distributed product in Israel both existing products as well as new products which we will be launching in Israel during the next few years. Going forward, we also expect meaningful growth from our existing proprietary IGG product portfolio as well as Glacia in the international markets outside of the U.S. Moreover, the contract manufacturing agreement we signed in late 2018 for an FDA-approved commercial stage specialty hyperimmunoglobulin product, which is currently in its technology transfer phase, is expected to have significant contribution to our plant utilization and growth starting in the beginning of 2023. In addition to all of that, we believe that our leading development programs, the IGG product for COVID-19 and the InHealth AAT, if approved have substantial market opportunities. Beyond the significant existing internal potential growth catalyst, we intend to utilize our strong balance sheet to identify additional business development opportunities that leverage our expertise and manufacturing capabilities. We are optimistic about the future of our business, and we are confident that our actions will generate significant shareholder value. Let's now turn to the current status of our innovative Phase III clinical program for our propriety in Health AAT for the treatment of Alpha-1 antitrypsin deficiency. As you will recall, we've been recruiting patients into the Phase III trial in Europe through February 2020. However, as we said on our last call in March, due to the effect of the COVID-19 pandemic on health care systems, Recruitment into the study was temporarily halted. I am pleased to report today that recruitment into the study restarted in June. As a reminder, INNOVATE is a randomized, double-blind, placebo-controlled, pivotal, phase three trial designed to assess the efficacy and safety of inhaled AAT in patients with alpha-1 deficiency and moderate lung disease. up to 250 patients will be randomized one-to-one to receive either inhaled AAT at a dose of 80 milligram once daily or placebo over two years of treatment. The primary endpoint of the INOVAIT trial is lung function measured by FEV1. Secondary endpoints include changes in lung density as measured by CT scan as well as other parameters of Disease Severity, such as additional pulmonary functions, reservations rate, and six-minute walk test. Before I turn the call over to Chaime for his review of the second quarter and the first half of 2020 financial review, I'd like to take this opportunity and mention the recent changes in our Board of Directors, which were also announced this morning. First, I would like to thank Mr. Leon Riccanati for his contribution to Kamada as an investor, director, and chairman, an office he held for the last seven years. His continued support and contribution to Kamada, and to myself personally, was invaluable. I believe that Ms. Lila Hasher Topilsky's nomination as Kamada's chairperson is indicative of Femi's confidence in the company's long-term growth prospects, market position, corporate strategy, and our solid management team. Over the past several months, since Lilakh's appointment to come on the board, she's made significant contribution, and I congratulate her on her appointment, and I look forward to our continued successful cooperation. As a background, the Femi Opportunity Fund is the leading private equity investor in Israel, and is Kamada's lead shareholder. Lastly, I'm happy to welcome Professor Ari Shamis to Kamada's Board of Directors. Ari's extensive experience as a senior executive at leading hospitals in Israel will be important in strengthening our business, including our commercial product, as well as our clinical pipeline. Professor Shamis is a highly respected healthcare authority in Israel and we look forward to his significant contribution to Kamada. With that, I'll now ask Chaime to review our financial results. Chaime.