Q2 2024 Kamada Ltd Earnings Call
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Operator: Greetings and welcome to Kamada Limited's second quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode.
Operator: Ch-Ch-Ch- [inaudible] right or wrong, but I don't know if I'm right or wrong, but I don't know if I'm right or wrong. [inaudible] [inaudible] [inaudible] I don't know. Greetings and welcome to Kamada Limited's 2nd Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief 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.
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Speaker Change: Greetings and welcome to Kamada Limited's 2nd Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode.
Operator: A brief 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.
Speaker Change: A brief question and answer session will follow the formal presentation.
Speaker Change: If anyone should require operator assistance during the conference...
Operator: As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Troy Williams, Lifesci Advisor. Thank you, Mr. Williams. You may begin. This conference called by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Kamada. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company forms 20-F and 6-K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking document.
Speaker Change: Please press star zero on your telephone keypad.
Troy Williams: It is now my pleasure to introduce your host, Mr. Troy Williams, Lifesay Advisor.
Operator: Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, Wednesday, August 14, 2021. Kamada undertakes no obligation to revise or update any statements to reflect events after the data.
Troy Williams: Thank you, Mr. Williams; you may begin. This conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Kamada. I encourage you to review the company's violence with a very easy-to-change commission, including, without limitation, that the company forms 20F and 6K, which identifies specific factors that may cause actual results, too, for events to differ materially from those described in the forward-looking statements.
Speaker Change: [inaudible]
Speaker Change: [inaudible]
Speaker Change: [inaudible]
Speaker Change: This conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Kamada.
Speaker Change: I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation that the company forms 20-F and 6-K, which identify specific factors that may cause actual results to, or events that differ materially from those described in the forward-looking statements.
Troy Williams: Furthermore, the contents of this conference call contain time-sensitive information that is accurate only as of the date of the live broadcast, Wednesday, August 14, 2024. Kamada undertakes no obligation to revise or update any statements to recollect events or circumstances after the date of this conference call.
Speaker Change: Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, Wednesday, August 14, 2024.
Speaker Change: Amada undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.
Troy Williams: With that said, it is my pleasure to turn the call over to Amir London, CEO. Amir. I have a review of our growth strategy, which is successfully reflected in the strong financial results we delivered in the second quarter and first half of 2024, and provided a summary of the drivers we are focused on for the balance of this year and into 2025.
Amir London: With that said, it's my pleasure to turn the call over to Amir London, CEO. Amir, please review our growth strategy, which is successfully reflected in the strong financial results we delivered in the second quarter and first half of 2024, and provide a summary of the drivers we are focused on for the balance of this year and into 2025. Then I'll turn the call over to Chaime for a more detailed review of our financial results.
Speaker Change: CEO. With that said, it's my pleasure to turn the call over to Amir London, CEO. Amir?
Speaker Change: [inaudible]
Amir London: Annabel Samimy, Amir London, Brian Ritchie, Chaime Orlev, Amir London
Amir London: Thank you very much for joining us today for a high-level review of our growth strategy, which is successfully reflected in the strong financial results we delivered in the second quarter and first half of 2024, and provide a summary of the drivers we are focused on for the balance of this year and into 2025.
Amir London: Then, I'll turn the call over to Jaime for a more detailed review of our financial results.
Amir London: Then, I'll turn the call over to Chaime for a more detailed review of our financial results.
Amir London: Following this, we will open the call for your questions. So, let's begin. I'm pleased to report that the strong financial and operational start of 2024 has reported that the last quarter continues through our second quarter, supporting and validating our growth strategy we are executing on. Kamada's growth strategy is built upon four main pillars: one, organic growth of our existing commercial portfolio of six FD approved products marketed in over 30 countries; secondly, M&A transactions, which expect to support and expedite our growth; thirdly, the plasma collection centers we are opening; and lastly, the ongoing Phase III pivotal trial over in held AET product that is targeting an over $2 billion market.
Amir London: Following this, we will open the call for your questions. So let's begin. I am pleased to report that the strong financial and operational start of 2024 that last quarter continued through our second quarter, supporting and validating our growth strategy we are executing on. Kamala's road strategy is built upon four main pillars.
Amir London: Following this, we will open the call for your questions.
Amir London: So let's begin.
Chaime: I am pleased to report that the strong financial and operational start to 2024, as reported last quarter, continued through our second quarter, supporting and validating our growth strategy we are executing on.
Chaime: Kamala's growth strategy is built upon four main pillars.
Amir London: One, organic growth of our existing commercial portfolio of six FDA-approved products marketed in over 30 countries. Secondly, M&A transactions, which are expected to support and expedite our growth. Thirdly, the plasma collection centers we are opening, and lastly, the ongoing phase 3 pivotal trial of our inhaled AAT product that is targeting an over $2 billion market. During the first six months of 2024, we have achieved significant progress advancing each of these growth catalysts, as I will shortly detail.
Kamala: One, organic growth of our existing commercial portfolio of six FDA-approved products marketed in over 30 countries.
Kamala: Secondly, M&A transactions, which are expected to support and expedite our growth.
Kamala: Thirdly, the plasma collection centers we are opening, and lastly, the ongoing phase 3 pivotal trial of our inhaled AAT product that is targeting an over $2 billion market.
Amir London: During the first six months of 2024, we have achieved significant progress advancing each of these growth catalysts, as I will shortly detail.
Kamala: During the first six months of 2024, we have achieved significant progress advancing each of these growth catalysts, as I will shortly detail.
Amir London: But first, I will provide a high-level summary of the financials. Total revenue were up 13% to $42.5 million for the second quarter as compared to the second quarter of 2023. An adjusted EBDA for the second quarter was $9.1 million, a 51% increase compared to the prior year quarter. Total revenues were up 18% to $80.2 million for the first half of 2024 as compared to the prior year period, and first half adjusted EBDA was $16.6 million, up 68% over the prior year period with the 21% margin of revenue. We are especially pleased with this substantial increase in profitability.
Amir London: But first, I'll provide a high-level summary of the financials. Total revenue was up 13% to $42.5 million for the second quarter as compared to the second quarter of 2020. An adjusted EBDA for the second quarter was $9.1 million, a 51% increase compared to the prior yield court.
Kamala: But first, I'll provide a high-level summary of the financials.
Kamala: Total revenue was up 13% to $42.5 million for the second quarter as compared to the second quarter of 2023.
Kamala: And adjusted EBITDA for the second quarter was $9.1 million, a 51% increase compared to the prior year quarter.
Amir London: Total revenues were up 18% to $80.2 million for the first half of 2024 as compared to the prior year period, and first half adjusted EBITDA was $16.6 million, up 68% over the prior year period, with a 21% margin of revenue. We are especially pleased with this substantial increase in profitability. In addition, for the first half of the year, we reported $15 million of cash provided by operating activities, which demonstrates our ability to convert our reported adjusted EBITDA to operational cash flow.
Kamala: Total revenues were up 18% to $80.2 million for the first half of 2024 as compared to the prior year period.
Speaker Change: and first half at Jatid Ibida was $16.6 million, up 68% over the prior year period with a 21% margin of revenue.
Speaker Change: We are especially pleased with this substantial increase in profitability.
Amir London: In addition, for the first half of the year, we reported $15 million cash provided by operating activities, which demonstrate our ability to convert our reported adjusted EBDA to operational cash flow. Based on our continued strong performance and expectation for a cadence of financial results in the second half of 2024 consistent with those achieved in the first six months of the year, we are reiterating our full year 2024 revenue guidance of between $158 million to $162 million and our adjusted EBDA guidance of $28 million to $32 million. We continue to benefit from the strengths of our diverse commercial portfolio, including our six FD approved products, with Cadum and Cytogram being our two key products.
Speaker Change: In addition, for the first half of the year, we reported $15 million of cash provided by operating activities, which demonstrates our ability to convert our reported adjusted EBITDA to operational cash flow.
Amir London: Based on our continued strong performance and expectation for a cadence of financial results in the second half of 2024 consistent with those achieved in the first six months of the year, we are reiterating our full year 2024 revenue guidance of between $158 million and $162 million and our adjusted EBITDA guidance of $28 million to $32 million. We continue to benefit from the strengths of our diverse commercial portfolio, including our six FDA-approved products, with Kedem and CytoGarm being our two key products, of Significant Post-Product, Demonstrated, Significant EOVU growth in the first half of the year compared to the first six months of 2020. During the first quarter, we completed the successful launch in Israel of our first biosimilar product.
Speaker Change: Based on our continued strong performance and expectation,
Speaker Change: For a cadence of financial results in the second half of 2024 consistent with those achieved in the first six months of the year, we are reiterating our full year 2024 revenue guidance of between $158 million to $162 million and our adjusted EBITDA guidance of $28 million to $32 million.
Speaker Change: We continue to benefit from the strengths of our diverse commercial portfolio including our six FDA approved products with Cadum and Cytogram being our two key products.
Amir London: Of significant, both products demonstrated significant e-over-year growth in the first half of the year as compared to the first six months of 2023. During the first quarter, we completed the successful launch in Israel of our first biosimilar product. We expect to launch our next biosimilar product at the end of this year, and we have several other in the pipeline to be launched in the coming years. We anticipated biosimilars will become an increasingly important aspect of our distribution business in Israel, with peak potential annual sales between $30 to $34 million. Importantly, we continue to maintain a very strong balance sheet.
Speaker Change: Of significance, both products demonstrated significant year-over-year growth in the first half of the year as compared to the first six months of 2023.
Speaker Change: During the first quarter, we completed a successful launch in Israel of our first biosimilar product. We expect to launch our next biosimilar product by the end of this year, and we have several others in the pipeline to be launched in the coming years.
Amir London: We expect to launch our next biosimilar product by the end of this year, and we have several others in the pipeline to be launched in the coming years. We anticipate that biosimilars will become an increasingly important aspect of our distribution business in Israel, with peak potential annual sales between $30 to $34 million. Importantly, we continue to maintain a very strong balance.
Speaker Change: We anticipate that biosimilars will become an increasingly important aspect of our distribution business in Israel, with peak potential annual sales between $30 to $34 million.
Speaker Change: Importantly, we continue to maintain a very strong balance sheet.
Amir London: We ended the second quarter with approximately $56.6 million in cash, and we have the financial strengths to both accelerate the growth of our existing business as well as pursue compelling business development and M&A opportunities. A process we remain actively engaged in and which could expand our commercial portfolio.
Amir London: We ended the second quarter with approximately $56.6 million in cash, and we have the financial strength to both accelerate the growth of our existing business, as well as pursue compelling business development and M&A opportunities, a process we remain actively engaged in and which could expand our commercial portfolio. These opportunities are expected to support our continued double-digit growth beyond 2024. As for our plasma collection centers, we continue to progress Kamada's plasma operation in the U.S. We are successfully expanding the specialty plasma collection capacity at our first center in Beamont, Texas, focused on the collection of anti-Rabies and anti-D plasma types, and are planning to open our new center in Houston, Texas by end of next month, while advancing the construction of a third site located in San Antonio which is expected to be open in early 2025, has a reminder that each new collection center contributes annual revenues between 8-10 million dollars.
Speaker Change: We ended the second quarter with approximately $56.6 million in cash, and we have the financial strength to both accelerate the growth of our existing business, as well as pursue compelling business development and M&A opportunities.
Speaker Change: A process we remain actively engaged in and which could expand our commercial portfolio.
Amir London: Radio. These opportunities are expected to support our continued double-digit growth beyond 2024. As for our Plasma Collection Centers, we continue to progress Kamada's plasma operation in the U.S. We are successfully expanding the specialty plasma collection capacity at our first center in Beaumont, Texas, focused on the collection of anti-rebus and anti-D plasma types and are planning to open our new center in Houston, Texas, by the end of the next month, while advancing the construction of our third site located in San Antonio, which is expected to be open in early 2025.
Speaker Change: These opportunities are expected to support our continued double-digit growth beyond 2024.
Speaker Change: As for our plasma collection centers, we continue to progress Kamada's plasma operation in the U.S.
Speaker Change: We are successfully expanding the specialty plasma collection capacity at our first center in Beamont, Texas, focused on the collection of anti-Rebbies and anti-D plasma types.
Speaker Change: and are planning to open our new center in Houston, Texas by end of next month, while advancing the construction of a third site located in San Antonio, which is expected to be open in early 2025.
Amir London: As a reminder, each new collection center contributes annual revenues between 8 to 10 million dollars. Looking further ahead at our growth pillars and catalyst, enrollment continues in our ongoing pivotal Phase III innovative clinical trial for inhaled AET therapy. As a reminder, at ADC we filed an IND amendment with the FDA that consisted of a revised statistical analysis plan and study protocol, which, if approved, may allow for the acceleration of the program. We continue to anticipate further after feedback before the end of this year. As we have said previously, in a parallel to the clinical and regulatory progress achieved here, we also continue to have discussion related to the potential partnering of this promising investigational late-stage product candidate, which targets a market of over $2 billion.
Speaker Change: As a reminder, each new collection center contributes annual revenues between $8 to $10 million.
Amir London: Looking further ahead at our growth pillars and catalysts, enrollment continues in our ongoing pivotal Phase III Innovate Clinical Trial for In-Health AET Therapy. As a reminder, earlier this year, we filed an IND amendment with the FDA that consisted of a revised statistical analysis plan and study protocol, which, if approved, may allow for the acceleration of the program. We continue to anticipate further FDA feedback before the end of this. As we have said previously, in parallel to the clinical and regulatory progress achieved here, we also continue to have discussions related to the potential partnering of this promising late-stage product candidate, which targets a market of over $2 billion. With that, I will now turn the call over to Chaime for a detailed discussion of our financial results for the second quarter and first half of 2021. Chaime, please go ahead.
Speaker Change: Looking further ahead at our growth pillars and catalysts, enrollment continues in our ongoing pivotal Phase III Innovate clinical trial for inhaled AET therapy.
Speaker Change: As a reminder, earlier this year we filed an IND amendment with the FDA that consisted of a revised statistical analysis plan and study protocol, which, if approved, may allow for the acceleration of the program.
Speaker Change: We continue to anticipate further FDA feedback before the end of this year.
Speaker Change: As we have said previously, in parallel to the clinical and regulatory progress achieved here, we also continue to have discussions related to the potential partnering of this promising investigational late-stage product candidate, which targets a market of over $2 billion.
Jaime: With that, I will now turn the call over to Jaime for a detailed discussion of our financial results for the second quarter and first half of 2024. Jaime, please go ahead.
Haimee: With that, I will now turn the call over to Chaime for a detailed discussion of our financial results for the second quarter and first half of 2024. Chaime, please go ahead.
Jaime: Thank you, Amir. As Amir stated at the top of the call, our performance continues to be excellent through the midpoint of 2024. Total revenues for the quarter were approximately 42.5 million, a 13% increase compared to the second quarter of 2023. For the first half of the year, total revenues were 80.2 million, up 80% in the prior year period. The first half sales represented 50% of the midpoint of our annual guidance. The year-over-year growth was primarily driven by increased sales of both KEDRAB and PSG due to increased demand for the two products in the US market.
Chaime Orlev: Thank you, Amir. As Amir stated at the start of the call, our performance continues to be excellent through the midpoint of 2024. Total revenues for the quarter were approximately $42.5 million, a 13% increase compared to the second quarter of 2020. For the first half of the year, total revenues were $80.2 million, up 80% from the prior year period.
Haimee: Thank you, Amir.
Haimee: As Amir stated at the top of the call, our performance continues to be excellent through the midpoint of 2024.
Haimee: Total revenues for the quarter were approximately $42.5 million, a 13% increase compared to the second quarter of 2023.
Haimee: For the first half of the year, total revenues were $80.2 million, up 80% from the prior year period.
Chaime Orlev: The first half sales represented 50% of the midpoint of our annual guidance. The year over year growth was primarily driven by increased sales of both CatRab and CycloGram due to increased demand for the two products in the U.S. Approximately 70% of our revenues during the first half of 2024 were generated by sales in the U.S. Total gross profit for the second quarter of 2024 was $19 million, representing a 45% margin compared to the $14.4 million, or 39% margin, in the prior year.
Haimee: The first half sales represented 50% of the midpoint of our annual guidance.
Haimee: The year-over-year growth was primarily driven by increased sales...
Speaker Change: of both CADRAB and CycloGram due to increased demand.
Speaker Change: for the two products in the U.S. market.
Jaime: Approximately 70% of our revenues during the first half of 2024 were generated by sales in the US market. Total growth profit for the second quarter of 2024 was $19 million, representing a 45% margin compared to the 14.4 million or 39% in the prior year period. Total growth profit for the first six months of 2024 was 35.7 million, representing a 45% margin, compared to 26.3 million and margin of 39% for the first six months of 2020. Operating expenses for the first six months of 2024 total $26 million and increase of 11% over the prior year period, which was in line with our expectation.
Speaker Change: Approximately 70% of our revenues during the first half of 2024 were generated by sales in the U.S. market.
Speaker Change: Total gross profit for the second quarter of 2024 was $19 million, representing a 45% margin compared to the $14.4 million, or 39% margin, in the prior year period.
Chaime Orlev: Tolu Gross Profit for the first 6 months of 2024 was $35.7 million, representing a 45% margin compared to $26.3 million and a margin of 39% for the first 6 months of 2024, operating expenses for the first six months of 2024.
Speaker Change: Total gross profit for the first six months of 2024 was $35.7 million, representing a 45% margin compared to $26.3 million, a margin of 39% for the first six months of 2022.
Speaker Change: Operating expenses for the first six months of 2024.
Chaime Orlev: $12.26 million, an increase of 11% over the prior year period, which was in line with our plan. The plan increase was in support of our expanded commercial activities, as well as our ongoing Phase 3 Innovate trial. Net income for the second quarter was $4.4 million, or $0.08 per diluted share, as compared to net income of $1.8 million, or $0.04 per share, recorded in the second quarter of 2020. In the first half of 2024, net income was $6.8 million, or $0.12 per share, versus negligible income for the same period in 2020.
Speaker Change: Total $26 million, an increase of 11% over the prior year period, which was in line with our expectations.
Jaime: A planned increase was in support of our expanded commercial activities, as well as our ongoing Phase 3 Innovate trial. Net income for the second quarter was 4.4 million or 8 cents per the looted share, as compared to net income of 1.8 million or 4 cents per share, recorded in the second quarter of 2023. For the first half of 2024, net income was 6.8 million or 12 cents per share, versus negligible income for the same period of 2023. Adjusted EBDA was 9.1 million in the second quarter of 2024, as compared to 6 million in the second quarter of 2023.
Speaker Change: The plan increase was in support of our expanded commercial activities, as well as our ongoing Phase 3 Innovate trial.
Speaker Change: Net income for the second quarter was $4.4 million, or $0.08 per diluted share, as compared to net income of $1.8 million, or $0.04 per share, recorded in the second quarter of 2023.
Speaker Change: For the first half of 2024, net income was $6.8 million, or $0.12 per share, versus negligible income for the same period of 2023.
Chaime Orlev: Adjusted EBDA was $9.1 million in the second quarter of 2024, as compared to $6 million in the second quarter of 2023. Adjusted EBDA was $16.6 million in the first six months of 2024, as compared to $9.9 million in the first six months of 2020. The adjusted EBITDA for the first half of the year represents a 21% margin of revenues and 55% of our mid-point annual guidance. Finally, our financial position remains strong and provides us with the strength and flexibility to accelerate the growth and profitability of our existing business and pursue compelling new business development options, which collectively will continue to support double-digit top and bottom line growth rates beyond. That concludes our prepared remarks. We will now open the call to questions. Thank you. There's nothing we can think of, question or not. You would like to ask a question. Hello, landmarks. Newton, Chaime Orlev.
Speaker Change: Adjusted EBITDA was $9.1 million in the second quarter of 2024 as compared to $6 million in the second quarter of 2023. Adjusted EBITDA was $16.6 million in the first six months of 2024 as compared to $9.9 million in the first six months of 2023.
Jaime: Adjusted EBDA was 16.6 million in the first 6 months of 2024, as compared to 9.9 million in the first 6 months of 2023. The adjusted EBDA for the first half of the year represented a 21% margin of revenues and 55% of our midpoint annual guidance.
Speaker Change: The adjusted EBITDA for the first half of the year represents a 21% margin of revenues and 55% of our mid-point annual guidance.
Jaime: Finally, our financial position remains strong and provides us the strength and flexibility to accelerate the growth and profitability of our existing business and pursue compelling new business development opportunities, which collectively will continue to support double-digit top and bottom line growth rates beyond 2024.
Speaker Change: Finally, our financial position remains strong and provides us the strength and flexibility to accelerate the growth and profitability of our existing business and pursue compelling new business development opportunities.
Speaker Change: which collectively will continue to support double-digit top and bottom line growth rates beyond 2024.
Jaime: That concludes our pre-very marks.
Operator: We will now open the call to questions. Thank you. Now we can think of a question in our session. If you would like to ask a question, please let us know, and we will give you that.
Speaker Change: That concludes our prepared remarks. We will now open the call to questions.
Speaker Change: Thank you.
Speaker Change: It was not a question and answer session.
Speaker Change: If you would like to ask a question, please press the star 1 button on the end of the QBR. Confirmation code will indicate your time has been entered. If you would like to remove your questions from the queue, for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Operator: I can't open the call when we need to. If you would like to remove your questions from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before passing with stockies.
Operator: We would like to remove your questions from, For participants using speaker equipment, it may be necessary to pick up a handset before passing the start. One moment, please, while we close for questions. The first question comes from the line of Annabel Samimy with CFL.
Operator: One more please, well, close the questions.
Operator: The first question comes on the line of Annable Sammy, which is safer. Please go ahead.
Speaker Change: One moment please, while we hold for questions.
Speaker Change: The first question comes from the line of Annabel Samimy with CFL, please go ahead.
Annabel Samimy: Hi everyone, thanks for taking my questions in such great order. I had a few here. First on inhaled AADT, I'm just curious, I know you're saying that you expect a response from FDA before the end of the year, but is there any dialogue during this period, and do you have any sense of where this might land? Is there any kind of pushback that you expect? And if they do, in fact, accept the new statistical plan, how could that impact the timing of the trial? How does it change the size, and maybe you can just help us understand what kind of impact that would have.
Annabel Samimy: Hi, everyone. Thanks for taking my questions in great quarter. So I had a few here.
Amir Pralassemi: Hi everyone, thanks for taking my questions in great order.
Annabel Samimy: First on the inhaled ADT.
Amir Pralassemi: So I had a few here. First, on the inhaled AADT, I'm just...
Annabel Samimy: I'm just curious. I know you're saying that the expected response from FDA before the end of the year, but is there any dialogue during this period? Do you have any sense of where this might land? Is there any kind of pushback that you expect? If they do, in fact, accept a new statistical plan. How could that impact the timing of the trial? How does it change the sizing? Maybe you can just help us understand what kind of impact that would have.
Amir Pralassemi: I was curious, I know you were saying that you expect a response from FDA before the end of the year, but is there any dialogue during this period and do you have any sense of where this might land? Is there any kind of pushback that you expect?
Speaker Change: and if they do, in fact, accept the new statistical plan, how could that impact the timing of the trial?
Speaker Change: How does it change the sizing?
Speaker Change: and the other people. So I'm going to start with you, and then maybe you can help us understand what kind of impact that would have. So that's my first
Amir London: So that's my first question. And then the second is if you could help us understand where enrollment is at this point, has enrollment become more competitive as we see a couple other players in the market, and to try and understand how you are in terms of timing. Okay, Annabel. Thank you for your question.
Annabel Samimy: That's my first question.
Annabel Samimy: Then the second is if you can help us understand where enrollment is at this point. Has the enrollment become more competitive as we see a couple of other players in the market to try to understand how you are in terms of timing there?
Speaker Change: Has the enrollment become more competitive as we see a couple other players in the market? And to try and understand how you are in terms of timing there.
Amir London: Hi, Annable. Thank you for your questions. As described during the call, we did submit the revised statistical plan to the FDA during the second quarter. We expect feedback before the end of the year. We didn't receive feedback yet. We're just waiting now to get the initial feedback, and if needed, there's going to be additional discussion between us and the FDA in order to have a clear roadmap in regards to that previous discussion about potentially changing the p-value for efficacy.
Amir London: So, as described... We did submit the revised statistical plan to the FDA during the second quarter. We expect feedback before the end of the year. But we haven't received feedback yet.
Annabel: Hi Annabel, thank you for your question.
Speaker Change: in the call, we submit. Let's submit.
Speaker Change: The revised statistical plan
Speaker Change: to the FDA during the second quarter. We expect feedback before the end of the year. We didn't receive feedback yet.
Amir London: So we're just waiting now to get the initial feedback, and if needed, there will be additional discussions between us and the FDA in order to have a clear roadmap in regards to that previous discussion about potentially changing the p-value for efficacy. Enrollment continues. We are around 40% to 45% into the study enrollment. In general, being a rare disease and being a placebo-controlled study, recruitment is always a challenge in those types of studies.
Operator: At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press stars zero on your telephone keypad. As a reminder, this conference is being recorded.
Speaker Change: So...
Speaker Change: We're just waiting now to get, you know, the initial feedback and if needed there's going to be additional discussion between us and the FDA in order to have a clear roadmap in regards to that previous discussion about potentially changing the p-value for efficacy.
Troy Williams: It is now my pleasure to introduce your host, Mr. Troy Williams, Lifesay Advisor. Thank you Mr. Williams, you may begin. This conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Kamada.
Amir London: Enrollment continues. We are around 40 to 45 percent into the study enrollment. In general, being a rare disease and being a placebo control study, recruitment is always a challenge in those types of studies, but we are making progress. We open additional sites recently, and we expect to complete enrollment to the study by end of next year. The impact of potentially reducing number of patients and other subjects will be reflected in a matter of a few months' difference in terms of recruitment into the study.
Speaker Change: Enrollment continues, we are around 40-45% into the study enrollment.
Speaker Change: In general, being a rare disease and being a placebo-controlled study, recruitment is always important.
Amir London: But we are making progress. We opened additional sites recently, and we expect to complete enrollment in the study by the end of next year. The impact of potentially reducing the number of patients, and the number of subjects, will be reflected in a matter of a few months' difference in terms of recruitment into the study.
Speaker Change: a challenge in those type of studies, but we are making progress. We opened additional sites recently.
Speaker Change: and we expect to complete enrollment to the study by end of next year. The impact of...
Speaker Change: Reducing, potentially reducing number of patients, number of subjects will be reflected in a matter of a few months difference in terms of recruitment into the study.
Troy Williams: I encourage you to review the company's violence with a very easy-to-change commission, including without limitation that the company forms 20F and 6K, which identifies specific factors that may cause actual results, too, for events to differ materially from those described in the forward-looking statements. Furthermore, the contents of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast Wednesday, August 14, 2024. Kamada undertakes no obligation to revise or update any statements to recollect events or circumstances after the date of this conference call.
Annabel Samimy: Ruby. Okay, great.
Annabel Samimy: Okay, great. And if I can have a follow-up on CMV, when can we expect the next data releases and any movement on the guidelines yet with regard to its use for prophylaxis in high-risk patients? Thanks. Do you mean CytoGAM and CMV?
Annabel Samimy: And if I can have a follow-up on CMV, when can we expect the next data releases and any movement on the guidelines yet, with regards to the use for prophylaxis and high-risk patients? Thanks. You mean, try to come in CMV? That's all the question? Yes, sorry, try to come in CMV, yes. So we are working with multiple USKOLs on different studies and different data collections initiatives based on either a kind of historical data which is already in their systems and is being pulled out in order to see the benefits of Cytogam versus standard of care primarily focused on the high-risk patient population.
Speaker Change: Okay, great, and if I can have a follow-up on CMV, when can we expect the next data releases and any movement on the guidelines yet with regards to its use for prophylaxis in high-risk patients?
Amir London: That was the question? Yes, sorry, CytoGAM and CMV, yes. Yeah. So we are working with multiple U.S. KOLs on different studies and different data collection initiatives, based on either a kind of historical data that is already in their systems and is being pulled out in order to see the benefits of CytoGAM versus the standard of care, primarily focused on the high-risk patient population. Working on the consensus document is something that the KOLs are doing; it's a process that is being revised or discussed every few months, every few years. Sorry.
Speaker Change: You mean Cytogam and CMV? That was the question? Yes, sorry. Cytogam and CMV. Yes. Yeah. So we are working with multiple U.S. KOLs on different studies and different data collections.
Speaker Change: Initiative. Thank you. Thank you.
Speaker Change: Based on either a kind of historical data, which is already in their systems And it's being pulled out in order to see the benefits of cytogum
Amir London: With that said, it is my pleasure to turn the call over to Amir London CEO, Amir. I have a review of our growth strategy, which is successfully reflected in the strong financial results we delivered in the second quarter and first half of 2024, and provided summary of the drivers we are focused on for the balance of this year and into 2025.
Speaker Change: versus the standard of care, primarily focused on the...
Amir London: Working on the conference document is something that the KOLs are doing. It's a process which is being revised or being discussed in every few months, every few years, sorry. So we expect we believe that this is going to be part of the next discussion of that forum. In general, I can say that the work that we have been doing since 2023, since last year, related to almost relaunching the product in the US market in terms of new clinical and medical data, having people on the ground talking to the physicians and presenting the data, is being fruitful.
Speaker Change: High-Risk Patient Population, working on the consensus document is something that
Speaker Change: The KOLs are doing, it's a process which is being...
Speaker Change: Revised, I've been discussing every few months, every few years, sorry.
Amir London: So we expect, we believe that this is going to be part of the next discussion in that forum. In general, I can say that the work that we've been doing since 2023, since last year, related to almost relaunching the product in the U.S. market in terms of new clinical and medical data, having people on the ground, you know, talking to physicians and presenting the data is being fruitful. And we see the results in this last six months' CytoGAM sales and CytoGAM performance, and we are optimistic that this will continue moving into next year and the years to come. Okay, great. Thank you.
Speaker Change: So we expect, we believe that this is going to be part of the next discussion of that forum. In general, I can say that the work that we've been doing since 2023, since last year,
Amir London: Then, I'll turn the call over to Jaime for a more detailed review of our financial results. Following this, we will open the call for your questions.
Speaker Change: related to almost relaunching the product in the U.S. market in terms of new clinical and medical data, having people on the ground talking to the physicians.
Amir London: So, let's begin. I'm pleased to report that the strong financial and operational start of 2024 has reported that the last quarter continues through our second quarter, supporting and validating our growth strategy we are executing on. Kamada's growth strategy is built upon four main pillars, one, organic growth of our existing commercial portfolio of six FD approved products marketed in over 30 countries, secondly, M&A transactions, which expect to support and expedite our growth, thirdly, the plasma collection centers we are opening, and lastly, the ongoing Phase III pivotal trial over in held AET product that is targeting an over $2 billion market. During the first six months of 2024, we have achieved significant progress advancing each of these growth catalysts as I will shortly detail.
Speaker Change: and presenting the data is being fruitful and we see the results in this last six months.
Amir London: And we see the results in these last six months, Cytogam cells and Cytogam performance, and we are optimistic that this will continue moving into next year and the years to come.
Speaker Change: Thank you very much.
Annabel Samimy: Okay, great, thank you.
Speaker Change: Okay, great. Thank you
Operator: Thank you. Thank you, and thank you for the questions, comments, or anything else at all. We hope you have a fantastic evening, and we'll see you next time. Hello, Amir and Chaime. This is Richard Henke with the Zags.
Speaker Change: Thank you.
Speaker Change: Thank you, and if you have any questions, please do not hesitate to contact me.
Richard: Hello, Amir and Jaime. This is Richard. Thank you for his axe. I'm calling on behalf of David Bouts. He's got a few questions for you. I think the first one you just answered, he was curious about how the timelines for the program for the FA3 Innovate trial would be possibly revised. And I think you used, you know, you stated David and answer on that or, you know, where things stand.
Richard Henke: I'm calling on behalf of David Bouts. He's got a few questions for you, and I think the first one you just answered. He was curious about how the timelines for the program for the Phase III Innovate trial would possibly be revised, and I think you stated you gave an answer to that or where things stand. So I guess his next question is, what is it, the AAT program? Are you focused on finding a global commercialization partner or possibly smaller regional partnerships? Could you talk about that a little bit? First question. I've just got a few questions.
Richard Henke: Hello Amir and Chaime, this is Richard Henke with Zaggs. I'm calling on the behalf of David Bautz. He's got a few questions for you and I think that the first one you just answered, he was curious about
Amir London: But first, I will provide a high-level summary of the financials. Total revenue were up 13% to $42.5 million for the second quarter as compared to the second quarter of 2023, an adjusted EBDA for the second quarter was $9.1 million, a 51% increase compared to the prior year quarter. Total revenues were up 18% to $80.2 million for the first half of 2024 as compared to the prior year period, and first half adjusted EBDA was $16.6 million, up 68% over the prior year period with the 21% margin of revenue.
Speaker Change: How the timelines for the program for the phase 3 innovate trial would be Possibly revised and I think you use you know you stated you gave an answer on that or you know where things stand So I guess his next question is the what is the AET program?
Richard: So I guess the next question is the, what is the AET program? Are you focused on finding a global commercialization partner, or possibly smaller regional partnerships? Could you talk about that a little bit?
Speaker Change: Are you focused on finding a global commercialization partner or possibly smaller regional partnerships? Could you talk about that a little bit? First question, I've just got a few questions.
Amir London: Number of first question. I've just got a few questions. Yeah, so we're talking with potential partners. It's primarily, of course, focus on the US and Europe. These are the two main markets where the business potentially, the patients are and the regulatory agencies that we're working with. It could be one partner for both territories. It could be, you know, two separate, two different partners for the two territories. So this is our focus, US and the European. And we're working with the FD and the EMA as regulatory agencies in order to get the product approved.
Amir London: So we are talking with potential partners. It's primarily, of course, focused on the US and Europe. These are the two main markets where the business potential patients are, and the regulatory agencies that we are working with could be one partner for both territories, or it could be two different partners for the two territories. So this is our focus, U.S. and Europe, and we're working with the FDA and the EMEA as regulatory agencies in order to get the product approved.
Speaker Change: Yeah, so we're talking with potential partners. It's primarily, of course, focused on the U.S. and Europe. These are the two main markets where the business potential is, the patients are, and the regulatory agencies that we're working with.
Amir London: We are especially pleased with this substantial increase in profitability. In addition, for the first half of the year, we reported $15 million cash provided by operating activities, which demonstrate our ability to convert our reported adjusted EBDA to operational cash flow. Based on our continued strong performance and expectation for a cadence of financial results in the second half of 2024 consistent with those achieved in the first six months of the year, we are reiterating our full year 2024 revenue guidance of between $158 million to $162 million and our adjusted EBDA guidance of $28 million to $32 million.
Speaker Change: It could be one partner for both territories or it could be two different partners for the two territories.
Speaker Change: So this is our focus, U.S. and European, and we're working with the FDA and the EMA as regulatory agencies in order to get the product approved.
Richard: Thank you.
Amir London: Next question, business development opportunities, are you guys open to licensing earlier stage assets or is the focus going to simply be on commercial stage products? The focus is on commercial stage or near commercialization stage products. So we would like to support the growth of the company, the commercial growth of the company, in addition to our strong organic growth, we would like to support it through M&A. The investment that was made last year by the Simmy Fund was specifically targeting other MNAs.
Richard: Next question: business development opportunities. Are you guys open to in-licensing earlier stage assets, or is the focus going to simply be on commercial stage products? The focus is on commercial stage or near commercialization stage.
Speaker Change: Next question, business development opportunities, are you guys open to in-licensing earlier stage assets or is the focus going to simply be on commercial stage products?
Speaker Change: The focus is on commercial stage or near commercialization stage.
Amir London: So we would like to support the growth of the company, the commercial growth of the company in addition to our strong organic growth. We would like to support it by M&A's. The investment that was made last year by the Simifan was specifically targeting another M&A's.
Speaker Change: So we would like to support.
Speaker Change: The growth of the company, the commercial growth of the company, in addition to our strong organic growth, we'd like to support it by M&As. The investment that was made last year by the FIMI fund was specifically targeting another M&As.
Amir London: We continue to benefit from the strengths of our diverse commercial portfolio including our six FD approved products, with cadum and cytogram being our two key products. Of significant, both products demonstrated significant e-over-year growth in the first half of the year as compared to the first six months of 2023. During the first quarter, we completed the successful launch in Israel of our first biosimilar product. We expect to launch our next biosimilar product at the end of this year and we have several other in the pipeline to be launched in the coming years. We anticipated biosimilars will become an increasingly important aspect of our distribution business in Israel with peak potential annual sales between $30 to $34 million.
Richard: I think we, the board, are happy with the transaction we've done late '21 and the way that we've integrated the new product we acquired back then into Kamada, establishing our US commercial team, and we would like to build on that success and to leverage that success with additional commercial products. Got it. All right. Thank you, Amir.
Amir London: We, the board, are happy with the transaction we did late 21 and the way that we integrated the new product we acquired back then into Kamada, establishing our U.S. commercial team, and we would like to build on that success and leverage that success with additional commercial projects. Got it. All right. Thank you, Amir.
Speaker Change: We, the board, are happy with the transaction we've done late 2021 and the way that we've integrated
Speaker Change: the new product we acquired back then into Kamada, establishing our U.S. commercial team, and we would like to build on that success and to leverage that success with additional commercial products.
Richard Henke: Final question. This is a positive cash flow starting to ramp up, which is fantastic. So keeping your retail ownership in mind and keeping our retail investor network in mind, any thought to potentially paying a dividend in the future? question or a comment?
Richard: Final question. This is a positive casual starting to ramp up, which is fantastic. So keeping your retail ownership in mind and keeping our retail investor network in mind, he thought to potentially paying the dividend in the future.
Speaker Change: Got it. All right. Thank you Amir. Final question.
Speaker Change: This is a, you know, positive cash flow starting to ramp up, which is fantastic. So keeping your retail ownership in mind and keeping our retail investor network in mind, any thought to potentially paying the dividend in the future?
Amir London: Importantly, we continue to maintain a very strong balance sheet. We ended the second quarter with approximately $56.6 million in cash and we have the financial strengths to both accelerate the growth of our existing business as well as pursue compelling business development and M&A opportunities. A process we remain actively engaged in and which could expand our commercial portfolio.
Amir London: It's a question or a comment. It's a question. So can you repeat the question, please? Yeah. You guys are starting to get your positive casual starting to ramp up. So now you guys have, with your retail ownership and our retail investor network that are interested in the stories, or any thought about potentially paying the dividend in the future. So you thought about that, and you talked about it. So we might pay dividend in the future. Currently we are focused on M&A's and BD transactions. Like you asked me on the previous question. Right. You'd like to utilize the money we are generating from the existing business to continue growing the business through M&A's.
Richard Henke: It's a question, so can you repeat the question, please? Yeah, you guys are starting to get, your positive cash flow is starting to ramp up. So now you guys have, you know, with your retail ownership and our retail investor network, you know, that were, you know, that are interested in the story, is there any thought about potentially paying a dividend in the future? Have you thought about that? Have you talked about it?
Speaker Change: It's a question, or a comment. It's a question. So can you repeat the question please?
Speaker Change: Yeah, you guys are starting to get... your positive cash flow is starting to ramp up.
Amir London: Radio. These opportunities are expected to support our continued double digit growth beyond 2024.
Speaker Change: So now you guys have, you know, with your retail ownership and our retail, you know, investor network, you know, that we were You know that that are interested in the stories or any thought about potentially paying a dividend in the future Have you thought about that? Have you thought about it?
Amir London: As for our Plasma Collection Centers, we continue to progress Kamada's Plasma operation in the U.S. We are successfully expanding the specialty Plasma Collection capacity at our first center in Beaumont, Texas, focused on the collection of anti-rebus and anti-D plasma types and are planning to open our new center in Houston, Texas by end of the next month, while advancing the construction of our third site located in San Antonio, which is expected to be open in early 2025. As a reminder, each new collection center contributes annual revenues between 8 to 10 million dollars.
Amir London: So we might pay dividends in the future. Currently, we are focused on M&As and BD transactions, like you asked me about in the previous question. And we would like to utilize the money we are generating from the existing business to continue growing the business through M&As. In the future, dividends could also be an option.
Speaker Change: So, we might pay dividends in the future. Currently, we are focused on M&As and BD transactions, like you asked me on the previous question, and we would like to utilize the money we are generating.
Speaker Change: from the existing business to continue growing the business through M&A's.
Amir London: In the future, dividend could also be an option. This is not something currently discussed or approved by the boat. Got it. Okay.
Richard Henke: This is not something currently being discussed or approved by the board. Got it. Okay. That was it.
Speaker Change: In the future, dividend could also be an option. This is not something currently discussed or approved by the board.
Amir London: Thank you very much, Amir. Thank you. The next question comes from the line of Troy Williams from Lifestyle Advisors.
Richard: That was that. Thank you very much, Amir. You're welcome.
You're welcome: Got it. Okay. That was it. Thank you very much, Amir. You're welcome.
Amir London: Looking further ahead at our growth pillars and catalyst, enrollment continues in our ongoing pivotal Phase III innovative clinical trial for inhaled AET therapy. As a reminder, at ADC we filed an IND amendment with the FDA that consisted of a revised statistical analysis plan and study protocol, which, if approved, may allow for the acceleration of the program. We continue to anticipate further after feedback before the end of this year. As we have said previously, in a parallel to the clinical and regulatory progress achieved here, we also continue to have discussion related to the potential partnering of this promising investigational late-stage product candidate, which targets a market of over $2 billion.
Troy Williams: Next question comes from the line of Tri-Williams from Lifesay Advisor's Peacecolyte. Thanks. I just wanted to see if you could expand on what your current market share of CADRAB is and your expectations there for the future. Thanks. So we believe that in the US market, CADRAB is anywhere between 40 to 50% market share. We continue growing the product. We continue taking market share. We believe the product is still room to grow. Above the 50% that we have been discussing in the past. We have the $180 million guaranteed revenues for this coming four years.
You're welcome: Thank you. Next question comes from the line of Troy Williams from Lifestyle Advisors. Please go ahead.
Troy Williams: Thanks. I just wanted to see... to expand on what's your current market share of Kedrab and your expectations there for the future? So we believe that in the U.S. market, Kedra is anywhere between 40 to 50% market share.
Troy Williams: Thanks. I just wanted to see if you could expand on what's your current market share of Kedrad and your expectations there for the future. Thanks.
Speaker Change: So we believe that in the U.S. market, CADRAB is anywhere between 40 to 50 percent market share.
Amir London: We continue growing the product, we continue taking market share, and we believe the product still has room to grow above the 50% that we have been discussing with you and the Kedron Group. Mr. Williams, are you done with the questions? Yes, that was all.
Speaker Change: We continue growing the product, we continue taking market share, we believe the product has still room to grow above the 50% that we have been discussing.
Jaime: With that, I will now turn the call over to Jaime for a detailed discussion of our financial results for the second quarter and first half of 2024. Jaime, please go ahead. Thank you, Amir. As Amir stated at the top of the call, our performance continues to be excellent through the midpoint of 2024. Total revenues for the quarter were approximately 42.5 million, a 13% increase compared to the second quarter of 2023. For the first half of the year, total revenues were 80.2 million, up 80% in the prior year period.
Speaker Change: We have $180 million guaranteed revenues for the coming four years. This is a minimum commitment by Cadrion and we believe that it can grow even further.
Amir London: This is like a minimum commitment by CADRAB, and we believe that it can grow even further.
Speaker Change: [inaudible]
Troy Williams: Mr. Williams, are you done with the question? Yes, that was all.
Speaker Change: Mr. Williams, are you done with your question?
Operator: Thank you. Thank you. Ladies and gentlemen, we have reached the end of the question and answer session. I would now like to turn the floor over to Amir London for closing.
Speaker Change: Yes, that was all. Thank you.
Operator: Ladies and gentlemen, we have reached the end of the question and answer session.
Speaker Change: Thank you. Ladies and gentlemen, we have reached the end of the question and answer session. I would now like to turn the floor over to Amir London for closing comments.
Amir London: I would now like to turn the floor over to Amir London for closing comments. Thank you very much. So, in closing, the successful execution of a growth strategy is reflected in the strong financial results we deliver in the second quarter and the first half of 2024. We are excited about our opportunities to advance the four main pillars of our growth strategy described during the presentation. We look forward to continuing to support clinicians and patients with the important life-saving products that we develop from the factory and commercialize. We thank all of our investors for their support and remain committed to creating long-term shareholder value.
Amir London: Thank you very much. In closing, the successful execution of our growth strategy is reflected in the strong financial results we delivered in the second quarter and the first half of 2024. We are excited about our opportunities to advance the four main pillars of our growth strategy, described during the presentation. We look forward to continuing to support clinicians and patients with the important life-saving products that we develop, manufacture, and commercialize. We thank all of our investors for their support and remain committed to creating long-term shareholder value.
Amir London: Thank you very much. So, in closing, the successful execution of our growth strategy is reflected in the strong financial results we delivered in the second quarter and the first half of 2024.
Jaime: The first half sales represented 50% of the midpoint of our annual guidance. The year over year growth was primarily driven by increased sales of both KEDRAB and PSG due to increased demand for the two products in the US market. Approximately 70% of our revenues during the first half of 2024 were generated by sales in the US market. Total growth profit for the second quarter of 2024 was $19 million, representing a 45% margin compared to the 14.4 million or 39% in the prior year period.
Speaker Change: We are excited about the opportunities to advance the four main pillars of our growth strategy.
Amir London: described during the presentation. We look forward to continuing to support clinicians and patients with important life-saving products that we develop, manufacture, and commercialize. We thank all of our investors for their support and remain committed to creating long-term shareholder value.
Amir London: We hope you all stay healthy and safe, and thank you for joining us on today's call.
Amir London: We hope you all stay healthy and safe, and thank you for joining us on today's call. Good day, everyone. Thank you. This concludes our teleconference today. You may disconnect your lines at this time. Thank you for your participation. The End, Upcoming Releases in October majdhhhhl Mew Soo So, Normal Mon Swag TOM HOMER Totally Mambo Omande Is this gonna be a love affair? Uh Mm Mmmm Do y e h thing Go Go Go, Ritchie, Troy Williams, Amir London, Brian Ritchie, Chaime Orlev, Kamada Ritchie, Troy Williams, Amir London, Brian Ritchie, Chaime Orlev, Kamada Ritchie, Troy Williams, Amir London, Brian Ritchie, Chaime Orlev, Kamada Ritchie, Troy Williams, Amir London, Brian Rit
Amir London: We hope you all stay healthy and safe and thank you for joining us on today's call.
Operator: Good day, everyone.
Operator: Thank you.
Speaker Change: Good day, everyone.
Operator: This concludes our today's teleconference. You may disconnect your lines at the time. Thank you for your participation. Thank you.
Speaker Change: Thank you.
Jaime: Total growth profit for the first six months of 2024 was 35.7 million, representing a 45% margin, compared to 26.3 million and margin of 39% for the first six months of 2020. Operating expenses for the first six months of 2024, total $26 million and increase of 11% over the prior year period, which was in line with our expectation. A planned increase was in support of our expanded commercial activities, as well as our ongoing phase 3 innovate trial.
Speaker Change: [inaudible]
Jaime: Net income for the second quarter was 4.4 million or 8 cents per the looted share, as compared to net income of 1.8 million or 4 cents per share, recorded in the second quarter of 2023. For the first half of 2024, net income was 6.8 million or 12 cents per share, versus negligible income for the same period of 2023. Adjusted EBDA was 9.1 million in the second quarter of 2024, as compared to 6 million in the second quarter of 2023.
Jaime: Adjusted EBDA was 16.6 million in the first 6 months of 2024, as compared to 9.9 million in the first 6 months of 2023. The adjusted EBDA for the first half of the year, represented 21% margin of revenues, and 55% of our midpoint annual guidance. Finally, our financial position remains strong, and provides us the strength and flexibility to accelerate the growth and profitability of our existing business, and pursue compelling new business development opportunities, which collectively will continue to support double digits top and bottom line growth rates beyond 2024.
Operator: That concludes our pre-very marks. We will now open the call to questions. Thank you. Now we can think of a question in our session. If you would like to ask a question, please let us know, and we will give you that. I can't open the call when we need to. If you would like to remove your questions from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before passing with stockies.
Operator: One more please, well, close the questions.
Annabel Samimy: The first question comes on the line of Annable Sammy, which is safer. Please go ahead. Hi, everyone. Thanks for taking my questions in great quarter. So I had a few here. First on the inhaled ADT. I'm just curious. I know you're saying that the expected response from FDA before the end of the year, but is there any dialogue during this period? Do you have any sense of where this might land? Is there any kind of pushback that you expect?
Speaker Change: I Who am I?
Annabel Samimy: If they do, in fact, accept a new statistical plan. How could that impact the timing of the trial? How does it change the sizing? Maybe you can just help us understand what kind of impact that would have. That's my first question. Then the second is if you can help us understand where enrollment is at this point, has the enrollment become more competitive as we see a couple of other players in the market to try to understand how you are in terms of timing there?
Amir London: Hi, Annable. Thank you for your questions. As described during the call, we did submit the revised statistical plan to the FDA during the second quarter. We expect feedback before the end of the year. We didn't receive feedback yet. We're just waiting now to get the initial feedback and if needed, there's going to be additional discussion between us and the FDA in order to have a clear roadmap in regards to that previous discussion about potentially changing the p-value for efficacy.
Amir London: Enrollment continues. We are around 40 to 45 percent into the study enrollment. In general, being a rare disease and being a placebo control study, recruitment is always a challenge in those type of studies but we are making progress. We open additional sites recently and we expect to complete enrollment to the study by end of next year. The impact of potentially reducing number of patients and other subjects will be reflected in a matter of a few months difference in terms of recruitment into the study.
Annabel Samimy: Ruby. Okay, great.
Amir London: And if I can have a follow-up on CMV, when can we expect the next data releases and any movement on the guidelines yet, with regards to the use for prophylaxis and high-risk patients? Thanks. You mean, try to come in CMV? That's all the question? Yes, sorry, try to come in CMV, yes. So we are working with multiple USKOLs on different studies and different data collections initiatives based on either a kind of historical data which is already in their systems and is being pulled out in order to see the benefits of cytogam versus standard of care primarily focused on the high-risk patient population.
Amir London: Working on the conference document is something that the KOLs are doing. It's a process which is being revised or being discussed in every few months, every few years, sorry. So we expect we believe that this is going to be part of the next discussion of that forum. In general, I can say that the work that we have been doing since 2023, since last year, related to almost relaunching the product in the US market in terms of new clinical and medical data having people on the ground talking to the physicians and presenting the data is being fruitful. And we see the results in these last six months cytogam cells and cytogam performance and we are optimistic that this will continue moving into next year and the years to come.
Annabel Samimy: Okay, great, thank you. Thank you.
Richard: Hello, Amir and Jaime. This is Richard. Thank you for his axe. I'm calling on the behalf of David Bouts. He's got a few questions for you. I think the first one you just answered, he was curious about how the timelines for the program for the FA3 innovate trial would be possibly revised. And I think you used, you know, you stated David and answer on that or, you know, where things stand.
Amir London: So I guess the next question is the, what is the AET program? Are you focused on finding a global commercialization partner or possibly smaller regional partnerships? Could you talk about that a little bit? Number of first question. I've just got a few questions. Yeah, so we're talking with potential partners. It's primarily, of course, focus on the US and Europe. These are the two main markets where the business potentially, the patients are and the regulatory agencies that we're working with.
Amir London: It could be one partner for both territories. It could be, you know, two separate, two different partners for the two territories. So this is our focus, US and the European. And we're working with FD and the EMA as regulatory agencies in order to get the product approved. Thank you.
Amir London: Next question, business development opportunities. Are you guys open to in licensing earlier stage assets or is the focus going to simply be on commercial stage products? The focus is on commercial stage or near commercialization stage. So we would like to support the growth of the company, the commercial growth of the company in addition to our strong organic growth. We would like to support it by M&A's. The investment that was made last year by the Simifan was specifically targeting another M&A's.
Amir London: I think we the board happy with the transaction we've done late 21 and the way that we've integrated the new product we acquired back then into Kamada establishing our US commercial team and we would like to build on that success and to leverage that success with additional commercial products. Got it. All right.
Amir London: Thank you, Amir.
Unnamed Speaker: Final question. This is a positive casual starting to ramp up, which is fantastic. So keeping your retail ownership in mind and keeping our retail investor network in mind and he thought to potentially paying the dividend in the future.
Amir London: It's a question or a comment. It's a question. So can you repeat the question, please? Yeah. You guys are starting to get your positive casual starting to ramp up. So now you guys have with your retail ownership and our retail investor network that are interested in the stories or any thought about potentially paying the dividend in the future. So you thought about that and you talked about it. So we might pay dividend in the future.
Amir London: Currently we are focused on M&A's and BD transaction. Like you asked me on the previous question. Right. You'd like to utilize the money we are generating from the existing business to continue growing the business through M&A's. In the future dividend could also be an option. This is not something currently discussed or approved by the boat. Got it. Okay. That was that.
Amir London: Thank you very much, Amir. You're welcome. Thank you.
Troy Williams: Next question comes from the line of Tri-Williams from Lifesay Advisor's Peacecolyte. Thanks. I just wanted to see if you could expand on what your current market share of CADRAB and your expectations there for the future. Thanks. So we believe that in the US market, CADRAB is anywhere between 40 to 50% market share. We continue growing the product. We continue taking market share. We believe the product is still room to grow. Above the 50% that we have been discussing in the past.
Troy Williams: We have the $180 million guaranteed revenues for this coming four years. This is like a minimum commitment by CADRAB and we believe that it can grow even further. Mr. Williams, are you done with the question? Yes, that was all. Thank you.
Operator: Ladies and gentlemen, we have reached the end of question and answer session.
Amir London: I would now like to turn the floor over to Amir London for closing comments. Thank you very much.
Amir London: So, in closing, the successful execution of a growth strategy is reflected in the strong financial results we deliver in the second quarter and the first half of 2024. We are excited about our opportunities to advance the four main pillars of our growth strategy described during the presentation. We look forward to continuing to support clinicians and patients with the important life-saving products that we develop from the factory and commercialize. We thank all of our investors for their support and remain committed to creating long-term shareholder value.
Amir London: We hope you all stay healthy and safe and thank you for joining us on today's call. Good day, everyone. Thank you.
Operator: This concludes our today's teleconference. You may disconnect your lines at the time. Thank you for your participation. Thank you.