Kamada Ltd.

Greetings and welcome to the Commodad Limited fourth quarter and fiscal year 2020 earnings call. At this time, all lines 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. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Bob Yedid with LifeSci Advisors. Thank you. You may begin.

Thank you, Melissa, and welcome to everyone joining the call. This is Bob Yedid from Lifestyle Advisors. Thank you for participating in today's call. And joining me are from Comida, Amir London, Chief Executive Officer, and Jaime Orlev, Chief Financial Officer. Early this morning, Comida announced financial results for the three and 12 months ended December 31, 2020. If you have not received this press release, please go to the investors page of the company's website. 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 and Exchange Commission, including without limitation, the company's forms 20F and 6K, which identify specific factors which 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, February 10th, 2021. Comida 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, Bob. My thanks also to our investors and analysts for your interest in Kamada and for participating in today's call. Let me begin by highlighting our strong overall financial results for full year 2020. Despite the significant headwinds caused by the global coronavirus crisis, we overcame meaningful operational challenges and met our key financial targets. For full year 2020, we recorded total revenues of $133.2 million, which is in line with our guidance of $132 million to $137 million. And the 5% increase over the $127.2 million in total revenue generated in 2019. In a year which was greatly impacted by COVID-19, we are pleased with this result and believe they indicate the fundamental strength of our business, which, as I will discuss shortly, will drive Commerzat growth prospects. Commerzat's core focus is on driving profitable growth from our current commercial activities and manufacturing expertise. We intend to expand our proprietary plasma-derived product business by maximizing the market potential of our existing proprietary product portfolio, broadening our distributed product portfolio, enhancing our current manufacturing capabilities, and evolving into a vertically integrated plasma-derived company. In addition, we continue to develop our pipeline, primarily focusing on the Pivotal Phase III Innovate Clinical Trial of Inhered AAT for the Treatment of Alpha-1 Antitrypsin Deficiency and on Exploring New Strategic Business Development Opportunities funded by our strong cash position of nearly $110 million as of December 31st, 2020. Moreover, we plan to leverage our FDA-approved IGG platform technology as a strategic business line with the ability to respond to future potential pandemic situations. Let me now elaborate on three of our recent important achievements executing on these key initiatives. I will start with our recently announced acquisition of the privately held Blood and Plasma Research, or BNPR, in Beaumont, Texas, and the establishment of our own subsidiary, Kamada Plasma, which 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. This facility specializes in collection of hyperimmune plasma used by Kamada to manufacture our NTD products, which are distributed in international markets. By investing in BNPR facility and leveraging its FDA license, to open additional centers in the U.S., we plan to significantly expand our hyperimmune plasma collection capacity. This planned expansion is expected to improve our IGG competitive position in various markets. We are extremely excited about the future opportunities this acquisition will provide for our business. Secondly, in regards to our COVID-19 IGG product, We believe this program clearly demonstrates our ability to quickly respond to emerging pandemic situations. We recently initiated the supply of this investigational product to the Israeli MOH for the treatment of COVID-19 patients in Israel. As a reminder, the initial order is sufficient to treat approximately 500 hospitalized patients and is expected to generate approximately $3.5 million in revenue for Ramadan. Importantly, the Israeli MOH has initiated a multi-center clinical study in which our product is being administrated. In parallel, we are ramping up our COVID-19 IgG manufacturing production, utilizing plasma collected in the U.S. by our partner, Kejiro Biopharma. This manufacturing increase will support potential additional demand from the Israeli MOH and possibly other international markets. We previously reported the completion of enrollment and positive insurance results from our Phase 1-2 open-label, single-arm, multi-center clinical trial. We are currently assembling the final study report, and we plan to publish it before the end of the current quarter. Together with Cadreon, our partner for the development program, we continue to evaluate the best suitable plan for the U.S. and or the EU COVID-19 IgG clinical program, and we will advance our development upon the conclusion of this review. While we are, of course, pleased that the rollout of COVID-19 vaccines has commenced in some countries, we remain confident that there will be a continued market demand for plasma-derived IgG as a treatment for COVID-19-infected patients. Thirdly, we continue to expand our Israel-based distribution segment by augmenting our existing distributed product portfolio. specifically in the emerging area of biosimilars. As recently reported, we entered into agreements with two international pharmaceutical companies to commercialize three biosimilar product candidates in Israel. Subject to approval by EMA and also by the Israeli MOH, the three products are expected to be launched in Israel between 2022 and 2024. These three products are added to the six other biosimilar products previously licensed from Alvotec, and further positioned Kamada as a leader in the emerging biosimilar market in Israel. We estimate the potential collective maximum sale generated by the distribution of this nine biosimilar product achievable following regulatory approval and within several years to be in the range of $25 million to $35 million annually. Before I summarize, let me now turn to the current status of our INNOVATE Phase III clinical program for our propriety in health AAT for the treatment of Alpha-1 anthocyanin deficiency. As a reminder, INNOVATE is a randomized, double-blind, placebo-controlled, pivotal Phase III trial designed to assess the success and safety of in health AAT in patients with Alpha-1 deficiency and moderate lung disease. While we continue to recruit patients into the study, the COVID-19 pandemic has limited our ability to open new study sites, and it continues to slow down the rate of recruitment, which has been true for many other clinical trials. From a strategic standpoint, we continue to evaluate parting opportunities for the development and commercialization of this important strategic pipeline product. In addition to the three significant strategic initiatives described above, our new plasma collection capabilities, the rapid development and supply agreement of the COVID-19 IGG, and the expansion of our biosimilar portfolio, we are intensely focused on driving higher organic growth by, one, continuing to increase CADRA market share in the U.S., where we believe we have significant room to grow. Two, expanding the sales of Glacier in our IGG portfolio in ex-U.S. markets, including the registration and launch of the product in new territories. Three, generating royalties from Glacier, projected to be in the range of $10 to $20 million per year, commencing in 2022. And four, leveraging our plasma-derived manufacturing capabilities for the provision of contract manufacturing services, such as those of the FDA-approved and commercialized specialty IGG product, which is expected to add between $8 to $10 million in annual revenue, starting in 2023. we continue to firmly believe in the strength of our business, which consists of multiple lines of activity, which can drive significant long-term growth opportunities for Kamada. With that, I now ask Jaime to review our financial results for the fourth quarter and the full year 2020. Jaime, please.