Q4 2023 Kamada Ltd Earnings Call

Okay.

Operator: Greetings. Welcome to Kamada Limited's fourth quarter and full year 2023 earnings conference call. At this time, all participants are in a listen-only mode.

Greetings and welcome to Communist Limited's fourth quarter and full year 2023 earnings conference call.

At this time all participants are in a listen only mode.

Operator: The question and answer session will follow the formal presentation. If anyone today should require operator assistance during the conference, please press star zero from your telephone keypad. Please note, this conference is being recorded. At this time, I'll turn the conference over to Brian Ritchie with LifeSciAdvisor. Mr. Ritchie, you may now begin.

A question and answer session will follow the formal presentation.

If anyone today should require operator assistance during the conference. Please press star zero from your telephone keypad.

Please note this conference is being recorded.

At this time I'll turn the conference over to Brian Ritchie with lifestyle advisors. Mr. Ritchie you may now begin.

Brian Ritchie: Thank you. This is Brian Ritchie with LifeSci Advisors. Thank you all for participating in today's call. Joining me from Kamada are Amir London, Chief Executive Officer, and Chaime Orlev, Chief Financial Officer. Earlier today, Kamada announced its financial results for the 3 and 12 months ended December 31, 2023. If you have not received this news release, please go to the investors page of the company's website at www.amada.com. Before we begin, I would 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 Kamada. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's 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

Thank you this is Brian Ritchie with lifestyle advisors. Thank you all for participating in today's call joining me from commodity Amir, London, Chief Executive Officer, and Jaime <unk> Chief Financial Officer.

Earlier today <unk> announced its financial results for the three and 12 months ended December 31st 2023.

If you have not received this news release. Please go to the investors page of the company's website at www dot amount of dotcom.

Before we begin I would.

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 commander I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation, the company's forms 20-F and <unk>.

6K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward looking statements. Furthermore, the content of this conference call.

Brian Ritchie: Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, Wednesday, March 6, 2024. Kamada undertakes no obligation to revise or update any of the statements to reflect events or circumstances after the date of this conference call. With that said, it is my pleasure to turn the call over to Amir London, CEO.

Time sensitive information that is accurate only as of the date of the live broadcast Wednesday March six 2024.

Undertakes no obligation to revise or update any of these statements to reflect events or circumstances. After the date of this conference call with that said it is my pleasure to turn the call over to a mere London CEO Amir.

Amir London: Thank you, Brian. My thanks also to our investors and analysts for your interest in Kamada and for participating in today's call. We are extremely pleased with the strong financial and operational momentum we experienced throughout our business during 2023, which allowed us to achieve our full-year guidance. Importantly, we are well positioned for further top and bottom line growth this year. I will begin with a high-level review of our robust financial results for full year 2023. With total revenues of $142.5 million, which represented year-over-year growth of 10%, and Yibida of $24.1 million, an increase of 35% as compared to the 12 months ended December 31st, 2022. We achieved the top and bottom line growth anticipated in our business during 2023. We continue to effectively leverage the growth drivers in our business, focusing on a significant increase in CADRAB US market share and promotion of CytoGram in the US market.

Thank you, Brian and thanks also to our investors and analysts for your interest in Colorado and for participating in today's call.

We are extremely pleased with our strong financial and operational momentum we experienced throughout toward business during 2023, which allowed us to achieve our full year guidance.

Importantly, we are well positioned for further top and bottom line growth.

I will begin with a high level review of our robust financial results for full year 2023.

With total revenues of $142 5 million, which was presented to you hopefully you grow 10%.

It would be down $24 1 million go, though an increase of 35% as compared to the 12 months ended December 31st 2022, we achieved the top and the bottom line growth anticipated business during 2023.

We continue to effectively leverage the growth drivers in our business focusing on the significant increase in ketchup U S market share and the promotional cycle in the U S market.

Amir London: Looking ahead, we expect the momentum generated last year to extend to 2024, with revenue and profitability to be meaningfully increased as compared to 2023. As such, we are introducing fully a 2024 revenue guidance of $156 million to $160 million and adjusted EBITDA guidance of $27 million to $30 million. The midpoint of these ranges would represent top line and profitability growth of approximately 11% and 18%, respectively, over 2020.

Looking ahead, we expect the momentum generated last year to extend through 2020 full with full year revenue and profitability to be meaningfully increased as compared to 2023.

As such we are introducing full year 'twenty twentyfold revenue guidance 156 million to $160 million and adjusted EBITDA guidance of 27 million to $13 million they.

They need the point of this range this would represent topline and profitability growth of approximately 11% and 18% respectively. Although 2023.

Amir London: To reiterate what we have said previously, we anticipate annual double-digit revenue and profitability growth in the foreseeable years beyond 2024, with significant upside potential and limited downside risk. Additionally, I would like to highlight our strong balance sheet. We ended the year with over $55 million in cash, and we continue to have the financial flexibility to both accelerate the growth of our existing business and pursue compelling business development opportunities, a process we are actively engaged in. In 2023, CADRAB, our anti-rabies immunoglobulin, was especially impactful. And throughout the year, we experienced a significant increase in demand for the product in the U.S.

To reiterate what we have said previously we anticipate annual double digit revenue and profitability growth in the foreseeable years beyond 2020, full with significant upside potential and limited downside risk.

Additionally, I would like to highlight our strong balance sheet. We ended the year with over $55 million in cash and we continue to have the financial flexibility to both accelerate the growth of all the existing business and pursue compelling Peters and set up into opportunities that process. We are actively in.

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In 2023 cat drop our anti rabies immunoglobulin, well, especially impactful.

Well do you experience a significant increase in demand so they told us in the U S.

Amir London: Following the recent amendment and extension of our distribution agreement with Cadrion, we fully expect this trend to continue in 2024 and beyond. The substantial market share growth demonstrated by Kedrub is being driven by Kedrion's extensive market coverage and robust commercial activity, as well as the FDA approval for a label expansion for the product obtained in 2021 that differentiates it as the first and only human ribosomal globulin available in the U.S. to be clinically studied in children. In 2023, Kamada generated approximately $32.8 million in revenues from sales of Cadrock to Cadrion for distribution in the U.S. market, which more than doubled our sales compared to 2022.

Following the recent amendment and extension of our distribution agreements as Catriona, we fully expect this trend to continue in 2024 and beyond.

The substantial market should grow demonstrated they can't drop is being driven by catch me on his extensive market coverage and robust commercial activity.

What does it actually have proven for a label expansion for the pro Doc for obtaining 'twenty 'twenty. One. So it has differentiated it is the first and only human rabies immunoglobulin available in the U S to be clinically studied in children.

In 2023 comment that generated approximately 32.8 million revenues from sales of catalog to catch me on for distribution in the U S. Small kids with small then doubled our sales compared to 2022.

Amir London: Based on the new distribution agreement, further growth is expected in 2024. Looking ahead to Kedrub, the amended and extended distribution agreement is a tremendous milestone for Kamada. In fact, this strategic agreement with Kedrub represents the largest commercial agreement since Kamada's inception. Specifically, within the first four years of the eight-year term, which began this past January, Kedron will purchase minimum quantities of Kedron with revenues to Kamada of approximately $180 million.

Based on the new distribution agreement with all the growth is expected in 'twenty 'twenty four.

Looking ahead with Cat club than men's and the amended and extended the distribution agreement is a tremendous milestone for comment though in fact, the strategic agreement with schedule and represents the largest commercial agreement since inception.

Basically within the first full use of the ATM, Tim which began this past January Camden will purchase minimum quantities of catch Robyn with revenues to Commodore of approximately $180 million.

Amir London: The revised financial terms have sent Kedrub significant U.S. market share and forecasted continued growth throughout the eight-year term, as well as the potential expansion of Kedrub distribution by Kedrion to other territories beyond the U.S. We believe the continuation of this partnership maximizes the future growth and value potential of this important product. Moreover, this agreement most effectively exploits the U.S. business by allowing us to focus our own internal sales efforts on the commercialization of our other specialized FDA-approved immunoglobulin products, primarily in transit consent, while Cadrion continues to promote care drugs in numerous hospitals and medical centers across the U.S. Moving on, our U.S. team, established in 2022, continues to achieve steady progress in promoting our specialty IgG portfolio to physicians and other healthcare practitioners through direct engagement and opportunities at medical meetings.

And besides financial tend to affect catch up significant market share and forecasted continued growth throughout the eighth uhm.

Well the potential expansion of catalog distribution to catch me on two other territories beyond the U S.

We believe the continuation of its partnership maximizes the future growth and value potential of this important product.

Moreover, these agreements most effectively exploit the U S business by allowing us to focus on the only channel and so therefore, all the commercialization of other specialized SBA approved hemoglobin many products.

Natalie and consequent centers when cadre on continues to promote Quechua numerous hospitals and medical centers across the U S.

Moving on our U S team established during 2022 continues to achieve steady progress in promoting our specialty portfolio.

Diesel and other heska position is through direct engagement and opportunities at medical meetings.

Amir London: As we said previously, our activities promoting these important therapies, primarily cytogram and varizig, represent the first time in over a decade that these hyperimmune specialty products are being supported by field-based activity in the U.S. Each of these products made an important contribution to our financial results in 2023, and we expect further impact this year. Importantly, in October 2023, results from an investigator-initiated five-year retrospective study consisting of 325 lung transplant patients evaluating the real-world use of cytogum in combination with antiviral agents for the prevention of CMV disease in high-risk CMV mismatched lung transplant recipients were published by Dr. Fernando Torres, the Clinical Chief, Division of Pulmonary and Critical Care at the University of Texas Southwestern Medical Center, and High-risk mismatch patients are CMV seronegative patients receiving a lung from a seropositive donor. Dr. Torres concluded that the use of proactive multi-modality CMV prophylactic consisting of antivirals and immune augmentation with CMV inoglobulin may improve outcomes among high-risk CMV mismatched lung transplant receptors.

As we've said previously our activities promoting this important therapies.

So I think I mean, obviously I present, the first time in over a decade this hyper immune specialty products.

Supported by field based activity in the U S.

Each of these products made important contributions to our financial results in 2023, and we expect further impact you see.

Importantly, it's all about 2023 results from an investigator initiated five year retrospective study consisting of 325 lung transplant patients evaluating the really won't use a site to come in combination with the anti viral agents for the prevention of CMV disease.

He is in high risk C. N V mismatched not transferred to see Piceance, well published by Doctor Fernando Torres The chiefs the clinical the clinical Chiefs division of pulmonary and critical care that the University of Texas Southwestern Medical Center.

The results were also presented at I D week 23 in Boston, Massachusetts.

He is mismatched patience I'll CMV seronegative patients receiving along from seropositive donor.

So totally has concluded that the use of proactive multi modality CMV prophylactic consisting of Antivirals and immuno limitation, we see globally and it may improve outcomes among high risk seemed V mismatch lung transplant recipients.

Amir London: We are in the process of sharing this result with physicians and transportation experts to promote the advantages of cytokinesis. We have already been notified that two additional studies related to the benefits of cytosome conducted by U.S. leading transplantation care centers were accepted for presentation at transplantation-related medical meetings this year. Of note, our CytoGram Scientific Advisory Board, which was established last year and consists of eight U.S.-based world-renowned thought leaders in the solid organ transplantation field, continues to evaluate new opportunities and future research and development possibilities for this important project. Moving on, looking further ahead at future catalysts, enrollment continues in the ongoing Pivotal Phase III Innovate clinical trial for inhaled alpha-1 antidepressant therapy for the treatment of alpha-1 deficiency, of Significance, which recently received positive feedback from the FDA in a meeting conducted with the agency.

We are in the process of sharing this result, as conditions and transportation experts promoting the advantage of cyclical.

We've already been notified that two additional studies related to the benefits of site to them conducted the U S. Leading transportation Kols were accepted for presentation at transplantation related medical meetings during this year.

Of note our site took him scientific Advisory Board, which was established last year and consists of eight U S based.

All we know and thought leaders in the solid organ transplantation field continues to evaluate new opportunities in future research and development possibilities for this important product.

Moving on looking further ahead the future catalyst enrollment continues.

Ongoing pivotal phase.

Phase III clinical trial for inhaled Alpha one antitrypsin therapy for the treatment of Alpha one deficiency.

Of significance, we recently received positive feedback from the F D. A.

<unk> conducted with the agency.

Amir London: The SKA reconceived our design of our ongoing clinical program and endorsed the Data and Safety Monitoring Board's unblinded positive safety assessment. The FDA also accepted our plan to conduct an open-label extension study, which is expected to be initiated in mid-2024. The agency also expressed its willingness to potentially accept a key value smaller than 0.1 alpha level in evaluating innovations for meeting the study efficacy primary endpoint for registration, which may allow for the acceleration of the program.

The FDA reconfirmed the overall design, although ongoing clinical program and endorsed the data and safety monitoring Board Unblinded positive safety assessment.

That's D also accepted our plan to conduct an open label extension study, which is expected to be initiated in mid 2024.

The agency also expressed its willingness to potentially accept a T value smaller than do appointing one alpha level.

Value 18, innovate for meeting the study's secrecy primary endpoint for registration.

They allow for the acceleration of the program.

Amir London: As a result, we plan to present a revised Statistical Analysis Plan, SAP, and study protocol for the innovative study and seek FDA feedback by mid-2024. As a reminder, the European Medicine Agency, the EMA, previously also reconfirmed the overall design of the ongoing innovative study and acknowledged the statistically and clinically meaningful improvement in lung function measured by FEV1 demonstrated in our prior Phase II-III European study. In parallel to the clinical and regulatory progress recently achieved, we also continue to have active discussions related to potential posturing of this promising late-stage product candidate. To reiterate what we have said previously, Kamada's investigational inhaled AAT treatment is a non-invasive at-home treatment with an expected better ease of use and quality of life for alpha 1 patients as compared to the current IEV standard of care.

As a result.

I have to present a revised study.

Cut analysis plan Sop and study protocol for the study and seek FDA feedback, but he needs 2024.

As a reminder of the European Medicines agency. The EMA previously also reconfirmed the overall design of the ongoing study and acknowledge the statistically and clinically meaningful improvement in lung function measured by F. N. B one demonstrated a trial phase two three European study.

In parallel with the clinical and regulatory progress recently achieved we also continue to have active discussions related to potential partnering of this promising late stage product candidates.

To reiterate what we have said previously.

Some of that was in the PK study and held a pre treatment is a noninvasive at home treatment with an expected better ease of use and quality of life. So I'll find patients as compared to current standard of care.

I mean has it brought us the leading new innovative also on treatment and advanced clinical stage and each represents substantial opportunity to be a transformational product in the market. It is already over $1 billion on sale in the U S and the EU.

Chaime Orlev: Bautz, Amir London, Chaime Orlev, Troy Williams, Kamada We also continue to be pleased with the progress achieved at Kamada Plasma, our U.S.-based plasma collection company. Our 2021 acquisition of the Plasma Collection Center in Houston, Texas represented Kamada's entry into the U.S. plasma collection market and supported our strategic goal of becoming a fully integrated specialty plasma product company. We continue to successfully expand the Hyperunion Plasma Collection capacity at our first center, and construction is nearly completed at our second plasma collection center located in Houston, Texas, expected to be open during the second half of this year. Finally, I'd like to note our new logo, which, if you're currently viewing the webcast, you've hopefully noticed by now. This new logo represents the transformation Kamada is going through as a leading, innovative, vertically integrated, profitable specialty plasma company. With that, I'll now turn the call over to Chaime for a deeper discussion of our financial results for the fourth quarter and the full year 2020. Honey, please go ahead.

We also continue to be pleased with the progress achieved it's come with a plasma or U S based plasma collection company.

Our 2021 acquisition of the plasma collection center in Houston, Texas, but presented Communist entry into the U S doesn't collection market.

Both of those so could you go to becoming a fully integrated specialty class a product company.

We continue to successfully expand the Hyperion your plasma collection capacity. The first center and construction is nearly completed the second plasma collection center located in Houston, Texas and expect it to be opened during the second half of TCU.

Finally, I would like to note a new logo launched a few weeks ago wage if you're currently viewing the webcast hopefully knock us right now.

These new logo are presenting their transformation comedy is going through its a leading innovative vertically integrated profitable specialty plasma company.

With that I'll turn the call over to Jaime.

A discussion of our financial results for the fourth quarter and the full year 2023.

Tiny please go ahead.

Chaime Orlev: Thank you, Amir. As previously highlighted, our business performed extremely well in 2020. Total revenues for the full year were approximately $142.5 million, a 10% increase from the $129.3 million recorded in fiscal year 2020. The year-over-year growth was primarily driven by increased sales of Kedra to Kedrion due to increased demand for the product in the U.S. While our cytogram sales during 2023 were a temporary impact, the short-dated inventory we initially purchased as part of the product acquisition in 2021, the technology transfer approval, We believe that our promotion of the product will support revenue growth during 2025. Total gross profit for 2023 was $55.5 million, representing a 39% margin, up 19% compared to $46.7 million, or a 36% margin in 2020.

Thank you Amir.

As previously high that highlight our business performed extremely well in 2023.

Total revenues for the whole year worth approximately $142 $5 million, a 10% increase from the $129 $3 million recorded in fiscal year 2020 to the.

The year over year growth was primarily driven by increased sales of catch up to country on due to increased demand for the product in the U S market.

While our siding sales during 2023 were temporarily impacted by the short dated inventory. We initially purchased as part of the product acquisition in 2021, the technology transfer approval.

And fresh product batches available since October 20th 23 ensure continuous long term supply of the product to the U S and Canadian market without interruption, we believe that our promotion of the product will support revenue growth during 2024.

Total gross profit for 2020 fleet was $55 $5 million, representing a 39% margin up 90% 19%.

Parents at 40, 617 million or 836% margin in 2022.

Chaime Orlev: As previously discussed, the company is accounting for amortization expenses associated with intangible assets which were generated through the late 2021 acquisition of our IGG, Prada. The company's progs in sales and marketing included approximately $5.4 million and $1.7 million, respectively, of such amortization expenses for full year 2021. Operating expenses, including R&D, sales and marketing, G&A, and other expenses, totaled $45.4 million, an increase of approximately 8% over the prior year.

As previously discussed the company is accounting for amortization expenses associated with intangible assets, which were generated through the late 2021 acquisition of G. G.

Product okay.

The company's Cogs and sales and marketing.

Included approximately $5 4 million and $1 $7 million, respectively of such amortization expenses for full year 2022.

Operating expenses, including R&D sales and marketing G&A and other expenses totaled $45 $4 million, an increase of approximately 8% over the prior year.

Chaime Orlev: The increase as compared to 2022 was below our original anticipation and related to the advancement of our commercial activities, as well as our ongoing phase three innovation. We expect our overall operating expenses, including R&D, sales, and marketing, and G&A, to increase between 10% to 15% during 2024 compared to 2020, as we continue to advance our commercial activities as well as our faith-free innovation. As we did throughout 2023 and 2022, we continue to account for financing expenses with respect to revaluation of contingent consideration and long-term soon liability, all of which are related to the acquisition completed in 2021. Revaluation of contingent consideration and the long-term assumed liabilities totaled $1 million during 2023, significantly lower than in 2020. Such decrease was associated with a temporary reduction in cytogram sales during 2020. Net income for the fiscal year 2023 was $8.3 million, or $0.15 per diluted share, as compared to a net loss of $2.3 million, or a loss of $0.05 per share recorded in 2020.

The increase as compared to 2022 was below our original anticipation and was related to the advancement of our commercial activities as well as our ongoing phase III innovate trial.

We expect our overall operating expenses, including R&D sales and marketing and G&A to increase between 10% to 15% during 2024 compared to 2020 as.

As we continue to advance our commercial activities as well as our phase III trial.

As we did throughout 2023 and 2022, we continue to account for financing expenses with respect to revaluation of contingent consideration and long term so likelihood at.

All of which are related to the acquisition completed in 2021.

Revaluation of contingent consideration and the long term assumed liabilities totaled $1 million during 2023 significantly lower than in 2022, such decrease was associated with a temporary reduction of cytokine sales during 2023.

Net income for the fiscal year, 'twenty, 'twenty, three with $8.3 million or 15 cents per diluted share as compared to the net loss of $2 3 million.

Or a loss of five cents per share recorded in 2022.

Chaime Orlev: Adjust the DBDAF for the 12-month end of December 31st, 2023, with $24.1 million, up 35% compared to the $17.8 million in the prior year. As Amir highlighted earlier, we anticipate continued momentum through 2024 with double digit top and bottom line growth. Specifically, we're introducing full-year 2024 revenue guidance of between $156 million and $160 million, and adjusted EBDA guidance of $27 million to $30 million. And finally, cash provided by operating activities was $4.3 million for the full year 2023, with total cash and cash equivalents. We maintain the financial strength and flexibility to accelerate the growth and profitability of our existing business beyond 2024 at double-digit rates and pursue compelling new business development opportunities.

Adjusted EBITDA for the 12 months ended December 31st 2023.

With $24 1 million up 35% compared to the $17 8 million in the prior year.

As a mirror highlighted earlier, we anticipate continued momentum through 'twenty 'twenty, four with double digit top and bottom line growth.

Specifically, we are introducing full year 2020 for revenue guidance of between 156 million to $160 million and adjusted EBITDA guidance of 27 million to 30 more.

Finally cash provided by operating activities was $4 $3 million for the full year 2023, with total cash and cash equivalent.

A $55 $6 million by the end of 2023 we maintain the financial strength and flexibility to accelerate the growth and profitability of our existing business beyond 2020 before at double digit rate and pursue compelling new business development opportunities.

Operator: That concludes our prepared remarks, and we will now open the call. Thank you. We'll now be conducting the question and answer session. If you would like to ask a question today, please press star 1 on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. If participants are using speaker equipment, it may be necessary to pick up your handset before pressing the star key.

That concludes our prepared remarks, and we will now open the call for questions.

Okay.

Thank you.

Well now be conducting a question and answer session.

If you'd like to ask a question today. Please press star one from your telephone keypad and a confirmation tone will indicate your line is in the question queue.

If I start to feel 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 keys.

Operator: One moment, please, while we poll for questions. Thank you. Thank you. And our first question is from the line of Annabel. Samimy with CIFL.

One moment. Please so we poll for questions. Thank you.

Thank you and our first question is from the line of Annabel.

So maybe with Stifel. Please proceed with your questions.

Annabel Eva Samimy: Please proceed with your questions. Hi, thanks for taking my questions. I have a few, actually.

Hi, Thanks for taking my questions I have a few actually.

Amir London: So first on Cytogam, what would the normalized growth rate have been for Cytogam without the interruption? And what type of Cytogam studies do you expect will be presented? If you can just give a little clarity on that. And then, the second question, I was wondering if we could dig a little deeper on the potential changes to the AAT program, the accelerated; what are some of the changes you propose to ensure that p-value? And would this also hold with the EU authorities?

So first on <unk>.

And again, what would the normalized growth rate have been for side again without interruption.

And what type of data.

The studies.

<unk> will be presented him if he can just give me a little clarity on that and then the second.

I was wondering if we.

We can dig a little deeper on the potential changes to the ATM program.

The accelerated what are some of the changes proposed a change to that P value and.

This also goes with the EU authorities and then I.

Amir London: And then, while we're on that topic, I'd love your thoughts on Sanofi's acquisition of Inhiberix and its implications for the AAT program in the market. And I'll probably get back to you after those questions. Thanks. Thanks, Annabel. I'm not sure I understood the last question. Let me start with the first two and then, if you can just repeat it.

While we're on that topic I'd love your thoughts on this acquisition.

Okay.

Locations for the HD program in the market.

Get back in queue. After this question. Thanks.

Yeah.

Thanks, Annabel I'm not sure I understood. The last question, let me start with the first two and then if you can just repeat it so it regards to sorry to come if it wasn't for the short dated inventory.

Amir London: So in regards to Cy2Gram, if it wasn't for the short-dated inventory, if I'm looking at end-user sales and user usage, 2023 numbers were similar to 2022, meaning that there is around a $5 million gap between the two years in terms of our. We expect this to go back to a place where it was in 2022 and even beyond. Because we do a lot of medical affairs and promotional activities in the market And so that's, I hope this answers your question regarding whether we try to kind of isolate the impact of the short-dated inventory on ourselves. And what type of studies are the investigators proposing, and how do they plan on expanding this market?

If I'm looking at end user sales end user usage 2023 numbers were similar to 2022.

Meaning that there is around $5 million gap between the two years.

In terms of a well.

Our sales to the channel through the wholesalers. So there's approximately the different the gap between the years.

And moving into 'twenty 'twenty full of calls with the fresh batches now available. We expect this to go back to a place where it was in 2022 and even beyond that because we do we do we do a lot of kind of medical affairs and promotional activities in the market to expect there in market share.

And the market usage.

<unk> started increasing.

So that's I hope this answers your question regarding if we try to kind of isolate the impact of the short dated inventory on ourselves.

Okay, and then and what type of studies R. R.

Or an investigator's proposing them how do they plan on expanding this market.

Amir London: Or the SAB, how do they think that they can expand the market? The two studies have already been accepted for presentation in 2024 at two different medical transportation-related medical conferences. Conference agendas, I believe, were not yet disclosed, so I cannot give the exact details of those two abstracts, but they have to do with the benefits of using a cytogram in addition to standard of care in the reduction of the viral load of the patients and improve their transplantation outcomes.

Oh I see.

How do they like that.

They understand the market.

The two studies have already been accepted for presentation in that 'twenty 'twenty, four and two different medical transportation related to medical conferences.

Yes, they'll same conference agenda, where I believe we're not yeah, that's disclosed so.

I cannot give the exact details of that.

To absorb but they have to do with the benefits of using <unk>.

The fact of gum in addition to standard of care.

The reduction of the viral load of the patients and improve their transportation outcome.

Okay, great and if we can afford to.

Amir London: Great. And if we can move over to the AAP program. Yes. I guess. What are some of the changes you propose to satisfy or accelerate the program, and is that going to be accepted by the EU as well? Hulk.

T program.

Yes.

I guess what are some of the changes proposed.

Two.

Fire accelerate the program and is that going to be accepted.

I E are as well.

Okay, great so in general.

Amir London: So, in general, I just want to start saying that we were very pleased with the positive figures from the FDA. As mentioned during the call, the agency reconfirmed the overall study design, endorsed the safety data which was reviewed by the DSMB and found it to be robust, so we presented the DSMB data, up to date in terms of the number of patients in the study who have completed a significant treatment duration, and we have very robust safety data, which really satisfied the agency and waived additional requirements for safety evaluation. And they have also accepted our open-label extension study, which is about to start in the middle of the year. We approached both agencies, the EMA and the FDA, with discussion questions related to potential ways to shorten the study duration and accelerate the program. We found the FDA team highly supportive and cooperative in the direction we're evaluating. The agency is willing to potentially accept and is agreeing that the T value will be 0.1. It will be sufficient to prove a frequency of FEV1 instead of the traditional 0.05.

I want to start saying that we were very pleased with the positive figures on the bats D. A.

As mentioned during the call the agency that we reconfirm. The overall study design endorsed the safety data, which was reviewed whether this can be and found it to be robust. So we presented the deals and b data and up to date in terms of number of patients in this.

Study, which are completed.

Significant treatment duration.

We are we have a very robust safety data, which really satisfied.

The agency in in waves additional requirements.

Safety evaluation and they also accepted the open label extension study, which is about to start middle of the year.

And we approach both agency the EMA and the F D a.

Whereas a discuss some questions related to potential ways to shorten the study duration et cetera with the program.

We found the SBA team highly supportive and cooperative in the direction. We are evaluating the agency's willing to potentially accept a degree that the P value would be 0.1.

Sufficient to prove the efficacy of actually want instead of the traditional zero point of view, we're sorry, we're preparing the revised statistical plan, which may show that we need less than 220 patients recruited to the study this really.

Amir London: We're preparing the revised statistical plan, which may show that we need less than 220 patients to be recruited to the study. If this indeed will be the case, then we'll be able to shorten the study duration due to quicker recruitment. With that information, we will go back to the EU, to the EMA, sorry, and basically get their consent to basically have the same path. Okay, great. And then I just want to know if you have any comments about the Sanofi acquisition of Inhibrix and their AOT program. Any thoughts around that?

That will be the case and then it's supposed to do.

Leave it the case that we were able to show in terms of study duration due to quicker recruitment.

With that information, we will go back to the U to the email sorry, and basically get their consent.

So too does he have the same path forward.

Okay, Great and then.

Just wanted to know if you had any comments about that.

Tennessee acquisition.

Hey, Brooks and they're a T program are there any thoughts around that.

Amir London: Yes, absolutely. So the Sanofi acquisition of the Inebrix program, which is a recombinant protein, we think it's a very important trend, a very important transaction. It puts a lot of focus on alpha deficiency in general. We believe that if the products make it to the market, Sanofi, with their significant marketing and promotional power, will create better awareness and greater awareness about alpha deficiency. As you may know, the majority of alpha 1 patients are still misdiagnosed or undiagnosed.

Yes, absolutely so listen I think when they saw the neighbor. It's a program, which is recombinant <unk> T. We think that's very important and a trend.

Trend is very important.

Transaction it puts a lot of focus a lot of times the efficiency in general we believe that these products will make it to the market Sanofi with their significant there.

Marketing and promotional power will create a better awareness and greater awareness from the efficiency. As you may know majority of the Alpha one patients are still missed the EIS and also theres enough, so and they like a powerhouse like Sanofi being active in there.

Amir London: So a powerhouse like Sanofi being active in the alpha 1 space will definitely significantly increase the market in general through better diagnostics and better coverage. So this is a very positive sign. In terms of Inherald, we believe Inherald has significant advantages in general. It's a non-invasive at-home treatment with a different mechanism of action. And we believe that if it makes it to the market, it's going to be a transformational product that will do very well in the market. The Inebrix Sanofi product, although it has advantages, it's still an IV treatment when we come with Inherald, which is non-invasive, and we come with an efficacy study. So we believe we have sufficient advantages, significant advantages, that if we make it to the market, it's going to be a highly competitive product. Also, the inhaled product, because we go directly into the lungs, versus IV treatment, we give one-eighth of the dose compared to the current standard of care, and approximately one-fifth of the dose compared to the Inibrix treatment. In terms of cost of goods, and potential competitiveness, we also have a significant advantage. Freedman

Also on space, we'll definitely going to significantly increase the market in general.

I'll stick some better coverage. So this is a very positive sign in terms of in house. We believe in held has significant advantages in general it's a noninvasive at home treatment with a different mechanism of action.

And we believe that if it if it makes it to the market is going to be a transformational pro Doc that is willing to compete very well in the market.

The neighborhood Sanofi product.

Although has advantages it's still an IV treatment.

Well, we can always inhales noninvasive and we call within a efficacy study.

We believe we have sufficient advantages significant advantages that this makes it the market is going to be highly competitive product also being held project because we go directly into the lungs versus the IV treatment. We gave one eighth of the doe's compared with the Collins started.

Kill and approximately one fifth of the dose compared to say new bricks treatment. So in terms of cost of goods.

And potential.

That's it from US and we also have a significant advantage.

Brian Ritchie: Thank you. At this time, I'll turn the call over to Brian Ritchie to see if we have any questions from the web. Thanks. Just a couple here, Amir and Chaime.

Thank you.

Is it back in the queue.

Thank you at this time I'll turn the call over to Brian Ritchie, Let's see if we have any questions from the web.

Okay.

Thanks, just a couple here a mirrored heinie werth, what could a potential partnership for inhaled <unk> to look like.

Amir London: First, what could a potential partnership for Inhaled AAT look like? Yes, so thank you, Brian. Building on what I just answered, Annabel, about the previous question, we believe that in-house Alfa 1 has significant advantages.

Yes, so thank you, Brian and so building on what I, just and sub Annabel on the previous question. We believe that our it has that song has significant advantages we believe that in order to compete well in the market, especially with a powerhouse like Sanofi.

Amir London: We believe that in order to compete well in the market, especially with a powerhouse like Sanofi, it will be a good move for Kamada to partner the program with a strategic partner that has significant marketing and commercial capabilities and resources. And we're looking for such a type of partnership that will allow us to bring the product to the market in the fastest way and to compete well with a superior product. Great. And then what? Maybe an update on that. BD product acquisition opportunities and what might be available.

Hey, it would be a good.

Good move for comedy to partner the program ways and its strategic part of it has a significant marketing and commercial capabilities and resources.

And we're looking for such type of partnership.

And that will allow us to bring the product to the market.

And the fastest way and to compete well with a superior product.

Great and then what.

Maybe an update on on.

B D product acquisition opportunities and what might be available.

Yeah.

Amir London: Yes, so we are proactively looking for products in the travel space, as well as in transplantation. This is a specialty we're covering. It will be very highly synergetic with our expertise and staff. Our Big D team is working proactively, evaluating some opportunities.

Yes, so we are proactively looking for product in the plasma space.

As well as in transplantation.

Do you see this person through recovering that be very highly synergetic with our expertise in and stuff.

T D D team is working proactively evaluating some opportunities.

Amir London: Once we have news to update the market, we'll be happy to do so. Great. Thank you. That's all the questions that have come in over the web.

Once we have news to update the market will be happily do so.

Great. Thank you that's all the questions that have come in over the web.

Amir London: I would ask you to maybe make some closing comments. Yes, so in closing, we're very pleased with our exceptional performance during 23 and excited about the potential opportunities that LIHEAD has based on the amendment, the amended care job agreement, the existing ongoing let's take in health alpha clinical program, and the strength of our commercial portfolio and balance. We look forward to continuing to support clinicians and patients with important life-saving products that we develop, manufacture, and commercialize. We thank you all for your support and remain committed to creating long-term shareholder value. We hope you all stay safe. Thank you very much. Thank you. This will conclude today's conference. We will disconnect your lines at this time. Thank you for your participation, and have a wonderful day!

Thank you to maybe make some closing comments.

Yeah.

Yes. So in closing, we're very pleased with our exceptional performance during the 20th three and excited about the potential opportunities that lie ahead based on the amendment amended.

Casualty agreement existing ongoing late stage inhaled Alpha one clinical program and the strength of our commercial portfolio and balance sheet. We look forward to continuing to support the nation's as patients with important lifesaving products that we develop an affection commercialized. We thank you all for your support.

We're committed to creating long term shareholder value.

We hope you all stay itself.

Nice and healthy thank you very much.

Thank you. This will conclude today's conference we disconnect your lines at this time. Thank you for your participation and have a wonderful day.

Yeah.