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Kamada Ltd.
8/11/2021
Greetings and welcome to the Commodore Limited second quarter 2021 earnings conference call. At this time, all participants are on listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press store zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Bob Yadid with LifeSci Advisors. Thank you. You may begin.
Thank you, Doug, and welcome to all our listeners. This is Bob Yadid with LifeSci Advisors. Thank you all for participating in today's call. Joining me from Comida are Amir London, Chief Executive Officer, and Jaime Orlev, Chief Financial Officer. Earlier this morning, Comida announced financial results for the three and six months ended June 30th, 2021. If you have not received this news release, please go to the investor's page of the company's website at www.comeda.com. Before we begin, I'd 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 Comeda. 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 identifies specific risk factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content in this conference call contains time-sensitive information that is accurate only as of the date of the slide broadcast, Wednesday, August 11, 2021. Kamada 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. I'm pleased to report today that our business continued to perform as anticipated through the first half of 2021. Jaime will provide the key details around our second quarter and first six months financial results shortly. But I'd like to indicate that despite the expected decrease in revenue as compared to the first half of last year, we achieved gross margins of 37% in the first half of this year, as compared to 34% during the first six months of 2020. With that, let me begin by indicating two recent advancements. The first is related to the workforce downsizing we previously discussed, which was largely completed during the second quarter. As we mentioned on our last call, this downsizing is expected to result in an annualized reduction in overall labor costs of approximately 10%. As a reminder, the downsizing was implemented in order to align our workforce to the lower utilization of our plant following the plant completion of the transition of Glacier Manufacturing to Takeda later this year. The second is the recent FDA approval of a label update for Kedrub, our human rabies immunoglobulin product, Atric, marketed by Kedrion in the US. This label expansion confirms our product safety and effectiveness in children. K-Dub is now indicated for passive, transient, post-exposure prophylaxis of rabies infection in persons of all ages when given promptly after contact with a rabid or possibly rabid animal. This FDA approval was based on data from a U.S. post-marketing pediatric study. the first and only clinical trial to establish pediatric safety and effectiveness of any H-Rig in the U.S. Importantly, this label update has the potential to increase CADRAB U.S. market share and product revenues. While the ongoing global COVID-19 pandemic continues to impact sales of CADRAB, we anticipate that sales of this product will continue to grow meaningfully in the years to come in the U.S. capturing a significant portion of the estimated annual $150 million U.S. H-Rig market. Turning to our product pipeline. The Innovate Phase III clinical program for a propriety-inhaled AAT for the treatment of Alpha-1 antitrypsin deficiency is continuing to progress. As a reminder, Innovate is a randomized, double-blind, placebo-controlled, pivotal Phase III trial performed under an IND and European CTA designed to assess the efficacy and safety of inhaled AAT in patients with alpha-1 deficiency and moderate lung disease. This high-priority program continues to be the focus of potential commercial partner discussions for us as we remain focused on evaluating strategic opportunities for this important product candidate in a market which is currently already estimated at over $1 billion and growing 6% to 8% annually. We are engaged in ongoing dialogue with multiple parties and are pleased with the level of external interest generated in our product. Potential partners have clearly recognized the value of this compelling development program. Let's move on to the progress of our plasma-derived hemoglobin product as a potential therapy for COVID-19 disease. During the second quarter, we completed the supply of the product to the Israeli Ministry of Health, per our initial supply agreement. As a reminder, the initial order from the Israeli Ministry of Health for the product is sufficient to treat approximately 500 hospitalized patients and has generated approximately $3.4 million in revenues for Kamada. The therapy is available nationwide in Israel and patients are continuing to be treated as part of the MOH clinical study, or on a named patient basis. We remain in active discussion with several countries regarding the possible supply of our IgG product. Moving on to Kamada Plasma, our U.S. plasma collection arm. We've initiated plans to leverage our FDA license and open additional centers in the U.S., through which we intend to significantly expand our plasma collection capacity. This plan expansion is expected to enhance our ITG competitive position in various markets. Lastly, we are having productive active discussions with multiple parties around new strategic business development opportunities that will utilize and expand our core plasma-derived development, manufacturing, and commercialization expertise. We are excited about the direction of this dialogue and believe there are interesting prospective transactions available to us that could significantly impact our business. As we have said previously, we are focused on identifying plasma-derived products that can be acquired or we can provide manufacturing services for. Our team remains highly focused on realizing these compelling opportunities, which will be funded by our strong cash position of nearly $105 million as of June 30th, 2021. As a reminder, our strategy is focused on driving profitable growth from our current commercial activities, as well as our plasma-derived product development and manufacturing expertise. As such, we intend to further evolve into a vertically integrated specialty plasma-derived company through the development and all the acquisition of plasma-derived products and distribution capabilities. In summary, we remain highly confident in the strengths of our overall business, which consists of multiple revenue-generating operating lines that can each drive significant long-term growth opportunities for Kamada. With that, I ask Jaime to review our financial results. Jaime, please.
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