Kamada Ltd.

Greetings. Welcome to the Commodad Limited first quarter 2021 earnings conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Bob Yetting. You may begin.

Thank you, operator, and thank you, everyone, for joining today's call. This is Bob Yedin with LifeSci Advisors. With joining me today from Comida are Amir London, Chief Executive Officer, and Jaime Orlev, Chief Financial Officer. Earlier this morning, Comida announced financial results for the three months ended March 31st, 2021. If you had not received this news release, please go to the investors page of the company's website at www.comida.com. Before we begin, I'd like to caution the 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 Exchange Commission, including without limitation the company's forms 20F and 6K, which identified 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 this live broadcast, Wednesday, May 12th, 2021. Comet undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. With those remarks, it's my pleasure to turn the call over to Amir London, CEO. Amir.

Thank you, Bob. I thank also to our investors and analysts for your interest in Kamada and for participating in today's call. While the global pandemic continues to create commercial challenges, our sales and financial results for the first quarter of 2021 were in line with our expectations. Jaime will provide all the key details around the first quarter financial results shortly, but I'd like to begin by highlighting the recently announced amendment to the Glacier License Agreement with Takeda, whereby upon completion of the transition of Glacier Manufacturing to Takeda, which is expected by the end of 2021, we would transfer to Takeda the Glacier U.S. BLA. In exchange for the BLA transfer, we will receive a $2 million payment from Takeda expected by the end of the year. In addition, the term of the final sales-based milestone of $5 million due to Kamada under the license agreement was amended and resulted in recognition of the income in the first quarter. Based on the 10th transition of Glycerin Manufacturing to Takeda later this year and its continued distribution of the product in the U.S., the transfer of the BLA to Takeda was a sound strategic next step for both sides. Also, in connection with the transition of Gladstone and affection to Tocada later this year, we are planning to implement a workforce downsizing during the early part of the third quarter, which is expected to result in an annualized reduction in labor costs of approximately 10%. These cost savings are in line with the plan to align our workforce to the lower plant utilization maintaining a profitable and effective operation meeting market demands. With that, I would like now to turn to our product pipeline and discuss our Innovate Phase III clinical program for our proprietary inhaled AAT for the treatment of Alpha-1 antitrypsin deficiency. As a reminder, Innovate is a randomized, double-blind, placebo-controlled, pivotal Phase III trial performed under an FDA IND and a European CTA designed to assess the efficacy and safety of inhaled AAT in patients with alpha-1 deficiency and moderate lung disease. This program continues to be a high priority for Karmada, and we continue to evaluate strategic opportunities for engaging a commercialization partner for this important product candidate in a market which is currently estimated at over $1 billion, and growing 6% to 8% annually. Moving on, I'd like to discuss the important progress we continue to achieve around the development of our plasma-derived immunoglobulin product as a potential therapy for COVID-19 disease. We were pleased to announce top-end results from our Phase I-II open-label single-arm multicenter clinical trial of our IgG product in Israel. To briefly reiterate the results, 11 of the 12 patients recovered following receipt of the treatment. Seven patients were discharged from the hospital at or before day five post-treatment, and the remaining four patients were discharged by day nine. Following the infusion of the product, IgG level in the plasma of all patients increased, and preliminary results demonstrated that the IgG level increase was associated with enhanced neutralization activity. In addition, we were encouraged to observe that our IgG product demonstrated a favorable safety profile and there were no infusion-related reactions or adverse events considered related to the study drug. Under our existing agreement, we continue to supply the product to the Israeli Ministry of Health, the MOH, for the treatment of COVID-19 patients in Israel. As a reminder, The initial order from the MOH for the product is sufficient to treat approximately 500 hospitalized patients and is expected to generate approximately $3.4 million in revenue for Kamada. The therapy is available nationwide in Israel, and patients are being treated as part of the MOH clinical study or on a named patient basis. During the first quarter, we also finalized the ramp-up in manufacturing of the product by utilizing plasma collected in the U.S. by Kedrion. This scaled-up manufacturing on our commercial scale production line can accommodate possible demand from additional international markets. We are currently in discussions with several countries regarding the potential supply of our IgG product. In general, we believe that even after global deployment of COVID-19 vaccination, there would still be specific populations that will continue to need and IgG products, mainly immunocompromised patients, which are expected to continue to be at risk due to their condition. Lastly, we believe that our activity during the COVID-19 pandemic clearly demonstrated our ability to quickly and professionally respond to such emerging situations. Moving on to the formation of Kamada Plasma, our new subsidiary in the U.S. We are extremely excited about the future opportunities provided by our recent acquisition of the Plasma Collection Center in Beaumont, Texas, and the establishment of our own collection capabilities. The acquisition represents our entry into the U.S. plasma collection market and drives us toward our strategic goal of becoming a fully integrated specialty plasma company. I am pleased to report today with integration and expansion activities are proceeding as planned at this facility. By leveraging our FDA license, we plan to open additional centers in the U.S., through which we intend to significantly expand our hyper-immune plasma collection capacity. This planned expansion is expected to improve our IgG competitive position in various markets. We look forward to sharing additional details with you regarding this potential growth opportunity in the coming quarters. Lastly, we continue to proactively explore new strategic business development opportunities that will utilize and expand our core plasma-derived development, manufacturing, and commercialization expertise. As a reminder, we are focused on identifying plasma-derived products that we can acquire or provide manufacturing services for. Our team is fully engaged, and we are currently in active discussions that we hope will lead to realizing these opportunities, which will be funded by our strong cash position of nearly $110 million as of March 31st, 2021. Our strategy is focused on driving profitable growth for our current commercial activities, as well as our plasma-derived product development and manufacturing expertise. As such, we intend to continue evolving into a vertically integrated specialty plasma-derived company through the development and all the acquisition of plasma collection and product distribution capabilities. In summary, we continue to firmly believe in the strength of our overall business, which consists of multiple lines of activity that can each drive significant long-term growth opportunities for Kamada. With that, I now ask Jaime to review our financial results for the third quarter of 2021. Jaime, please.