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spk03: 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.
spk01: 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?
spk00: 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.
spk02: Thank you, Amir, and good day, everyone. As Amir noted, our business performed as expected throughout the first half of 2021. In the second quarter of 2021, total revenues were $24.2 million compared to $33.1 million for the second quarter of 2020. For the first six months of 2021, total revenues were $49.1 million compared to $66.4 million in the similar period of 2020. This decrease is mainly related to the expected reduction of sales of Glassy to Takeda due to the product manufacturing transition that will be completed this year. During the first six months of 2021, we sold approximately $17 million of Glacier to Takeda, which is part of our overall expected 25 million in products revenue from the supplier to Takeda for full year 2021. From a profitability standpoint, gross profit for the second quarter of 2021 was 9.1 million as compared to 11.1 million in the second quarter of 2020. For the first six months, our total gross profit was $18 million as compared to 22.6 million of total gross profits in the first six months of 2020. In both the second quarter and first half of 2021, our gross margins were 37%. an increase from 34% in the equivalent period in 2020. Looking ahead to the second half of 2021, we do expect a shift in product sales mix with higher weighted sales in our distribution product, which have lower gross margins, as well as continued reduction in Glossier sales to Takeda. Therefore, we would not expect our gross margins in the second half of the year to be as strong as they were in the first half. Operating expenses in the second quarter of 2021 included approximately 600,000 in other expenses related to a one-time severance-related cost associated with the workforce downsizing, which was largely concluded. Moving on, net income was approximately 900,000, or two cents per share, in the second quarter of 2021 as compared to net income of 3.5 million or 10 cents per share in the second quarter of 2020. For the first six months, net income was 3.6 million or 8 cents per share as compared to net income of 8.7 million or 20 cents per share in the first six months of 2020. So the first half of 2021, our adjusted EBITDA excluding the one-time severance cost, was $6.7 million compared to $11.8 million in the first half of 2020. Summit as a balance sheet continues to be a significant strength of our company. As of June 30th, 2021, the company had cash, cash equivalents, and short-term investments of approximately $105 million as compared to approximately $109 million on December 31st, 2020. The decrease is mainly related to working capital timing differences. As Amir mentioned, we intend to leverage these cash resources for expansion of our plasma collection activity and targeted strategic business development opportunities. That concludes our prepared remarks. We will now open the call for questions. Doug?
spk03: Thank you. Ladies and gentlemen, at this time, we would like to conduct a question and answer session. If you'd like to ask your question, you may press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. Our first question comes from the line of Anthony Petron with Jefferies. Please proceed with your question.
spk04: Uh, good morning gentlemen and, uh, congrats on, on a first, uh, strong execution over the past first half through the pandemic here. Uh, first question would be on, on timing for Bond City, the biosimilar for Terra Paratide. And I know that's still on track for, for next year, just trying to get a sense of, uh, you know, sort of launch preparations behind the scenes and sort of expectations into 2022 for that product. And then similarly on the hyperimmune globulin contract manufacturing, contract signed last quarter, 12-year agreement with an undisclosed partner. Just, again, timing on when that will begin and how that's going to ramp over the next couple of years. And then I'll have a few follow-ups. Thanks.
spk00: Hi, Anthony. Tamir, thank you for the questions. So regarding the biosimilar, yes, we are on track. We are on track to get the product launched early next year, in 2022, as we've indicated in previous discussions. And regarding the tech transfer, this is also moving forward according to the plan. We are going to manufacture the different validation batches over the next few months. We plan to submit the file amendment to the FDA, and we are on track to have the product approved to be manufactured at our facility before the end of 2022 and initiate commercial production in the beginning of 2023, according to the plan. This is a 12-year agreement with expected a revenue that can be as high as $10 million a year for a total of $120 million for the course of the agreement.
spk04: Okay, and then on the follow-up here, you've sort of indicated here on the Innovate trial and the development of Inhalable, potentially their strategic partnerships in the mix there. Just maybe sort of the latest thoughts there on how this asset could actually evolve now that you're seeking partnerships. And then the last one I'll squeeze in will be on plasma centers. The company has been adding capabilities on that end. Maybe just a broader sort of outlook on the initiatives in the supply chain. How many plasma centers overall do you think Kamada will have at critical mass? And will those be exclusively hyperimmune focused or just broader as it relates to plasma collections overall. Thanks.
spk00: Thank you. Thank you for the question. Regarding the INNOVATE study, the study is ongoing, and we are in the process of expanding it with a plan to open additional sites. The partnering process, as we've indicated in the prepared remarks, is ongoing. It's a high focus for us for bringing on board potential commercial partners. In terms of more details, we'll be happy to share this when things will mature and materialize. We are in discussions with multiple parties. We are pleased with the level of interest that has been generated today by this program, by the different parties, and we believe this is definitely an important validation, having external partners recognizing the value of this compelling development program. So stay tuned, and we will update once we have more information about this potential commercialization agreement. In regards to Kamada Plasma, so the site in Texas, the one that we've acquired, we have completed the integration of that into Kamada according to the plan. We are growing the capacity of that facility. This facility is focused on hyperimmune collection, only hyperimmune collection. while in terms of our plan moving forward, our focus, at least for the time being, will continue to be on the hyperimmune plasma. It's important for us to be vertically integrated, and as we come at the focus on specialty hyperimmune plasma products, we are planning to be fully vertically integrated in that regard. We are not ruling out the option that part of the plan we will also be collecting source plasma. Once our plan is finalized, we will share it with you and with the public in terms of how many centers, how many liters of plasma we plan to collect, and how we are going to go about this network of plasma collection centers in the U.S. But this is definitely part of our strategy to be a player in the plasma collection space. for Kamada internal needs, but also potentially as a company that will be selling Plasma to external clients.
spk04: Thanks again, Amir.
spk03: If there are no further questions in the queue, I'd like to hand the call back over to Amir London for closing remarks.
spk00: Thank you. In closing, we remain confident in the strengths and the fundamentals of our business. and we look forward to executing on multiple potential compelling partnership and business development opportunities by utilizing our solid balance sheet. We also leverage our core expertise in development and effecting and commercialization of plasma-derived therapeutics to further our evaluation into a vertically integrated company by expanding our plasma collection capabilities. Thank you all for joining us on today's call. We look forward to providing you with further updates on our progress during the second half of the year. We hope you all stay healthy and safe. Thank you very much.
spk03: Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time and have a wonderful day.
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