Q3 2023 Kamada Ltd Earnings Call
[music].
Speaker 1: Good day ladies and gentlemen and welcome to Kamada Limited's third quarter of 2023 earnings conference call.
Good day, ladies and gentlemen, and welcome to chicken items in this quarter.
Streety Street earnings Conference call.
Speaker 1: At this time, all participants are either sent only most. A question and answer session will follow the formal presentation.
At this time, all participants are in listen only mode.
A question and answer session will follow the presentation.
As a reminder, this country's cool is being recorded.
Speaker 1: I will now turn the conference over to Mr Brian Ritchie. Please go and hit sir.
I'll now turn the conference at the tooth, which Brian Ritchie. Please go ahead Sir.
Speaker 2: Thank you. This is Brian Ritchie with LifeSci Advisors. Thank you all for participating in today's call. Joining me from Kamata, Amir London, Chief Executive Officer, and Jaime Orloff, Chief Financial Officer.
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, Jaime <unk> Chief Financial Officer.
Speaker 2: Earlier today, Komata announced its financial results for the three and nine months ended September 30, 2023. If you have not received this news release, please go to the investors page of the company's website at www.komata.com.
Earlier today, <unk> announced its financial results for the three and nine months ended September 32023.
If you have not received this news release. Please go to the investors page of the company's website at www dot commodity dot com.
Speaker 2: Before we begin, I would like to caution that comments made during this conference called by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Kamado.
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 tomorrow.
Speaker 2: I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's forms 20F and 6K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statement. I challenge you to review the company's filings with the Securities and Exchange Commission,
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 6K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward looking statements.
Speaker 2: Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast.
Furthermore, the content of this conference call contains time sensitive information that.
Exactly only as of the date of the live broadcast Monday November 13 2023.
Speaker 2: MATA undertakes no obligation to revise or update any statement to reflect events or circumstances after the date of this conference call. With that said, it's my pleasure to turn the call over to Amir London, CEO . Amir?
Mana undertakes no obligation to revise or update any statements to reflect events or circumstances. After the date of this conference call with that said, it's my pleasure to turn the call over to Amir London CEO Amir.
Yeah.
Speaker 3: Thank you, Brian . My thanks also to our investors and analysts for your interest in Amada and for participating in today's call.
Thank you Brian.
Thanks also to our investors and analysts for your interest in Colorado and football dissipating in today's call.
Speaker 3: to begin, I'd like to indicate that the company continues to conduct its business operation in Israel with no effect on business continuity.
To begin I'd like to indicate that the company continues to conduct its business operation in Israel with no effect on business continuity at global supply of Florida, you don't expect it to be interrupted as a result of the recent events is right.
Speaker 3: and its global supply of products is not expected to be interrupted as a result of the recent events in its
Speaker 3: With that, I now pivot to the strong financial and operational momentum throughout our business that has us well positioned to achieve our 2023 full year guidance, which I will discuss momentarily.
With that now he's up to the strong financial and operational momentum.
That's a business that has us well positioned to achieve our 2023 fully your guidance, which I will discuss momentarily.
Speaker 3: I'll begin with a high-level review of our robust financial results for the first nine months of 2020.
I'll begin with a high level review of our robust financial results for the first nine months of 2023 with total revenues of $106 1 million, which represented year over year growth of 26% and adjusted EBITDA of $17.7 million an increase of <unk>.
Speaker 3: With total revenues of $106.1 million, which represented year-over-year growth of 26%, an adjusted EBD gap of $17.7 million, an increase of 67% as compared to the first nine months of 2022, we achieved the top and bottom line growth anticipated in our business in the first nine months of the year.
67% as compared to the first nine months of 2022, we achieved the top and bottom line growth anticipated in our business in the first nine months over the year.
Speaker 3: We continue to effectively leverage the multiple growth drivers in our business, including a significant increase in CADRAB sales to CADRION for distribution in the U.S. market, the portfolio of four FDA-approved immunoglobulins acquired in late 2021, Cytogum, Hepagum, Vavizib and Winro, and our Israeli distribution business.
We continue to effectively leverage the multiple growth drivers in our business, including a significant increase in CAG sales to catch me on for distribution in the U S market the portfolio a full FDA approved even though global names acquired in late 2021, cytokine HIPAA going forward, you're going to enroll.
Is there any distribution business.
Speaker 3: Looking ahead, we expect the momentum for the first nine months of the year to extend through the fourth quarter of 2023, with annual profitability to be increased as compared to last year. As such, we are reiterating our full year 2023 revenue guidance of $138 million to $146 million and adjusted EBITDA of $22 million to $26 million.
Looking ahead, we expect the momentum for the first nine months of the year to extend this to the fourth quarter of 2023.
And your profitability to be increased as compared to last year as such we are reiterating our full year 2023 revenue guidance of $138 million to 146 million tolar, and adjusted EBITDA of $22 million to $26 million.
Speaker 3: The midpoint of that range would represent the stability growth of the proximity 35% over 2026.
The midpoint of this range would represent profitability growth of approximately 35% over 2022.
Speaker 3: To reiterate what we have said previously, beyond 2023, we continue to anticipate annual double-digit revenue and profitability growth in the foreseeable years ahead, with significant upside potential and limited downside risk.
To reiterate what we have said previously beyond 'twenty to 'twenty three we continue to anticipate annual double digit revenue and profitability growth in the foreseeable use ahead with significant upside potential and limited downside risk.
Speaker 3: While I noted our multiple growth drivers earlier, CADRAP, our anti-rabid hemoglobin, has been especially impactful during the first nine months of 2023, a trend we expect to continue in the fourth quarter and beyond.
While I noted that with multiple growth drivers and the other cat drop all empty rabbits hemoglobin has been.
Absolutely impactful during the first nine months of 2023, a trend we expect to continue in the fourth quarter and beyond.
Speaker 3: Throughout the first nine months of 2023, we experienced a significant increase in demand for the products in the U.S., and we anticipate the continuation of this momentum moving forward.
Well the first nine months of 'twenty, three we experienced a significant increase in demand for the products in the U S and we anticipate the continuation of this momentum moving forward.
Speaker 3: The significant market share growth demonstrated by KEDLAB is being driven by Kedrion's excellent commercial activity and thanks to the FDA approval obtained in 2021 for a label expansion for the product that has differentiated it as the first and only human rabies immunoglobulin available in the U.S. market to be clinically studied in children.
Second market your growth demonstrated by catch up is being driven by cadre alums excellent commercial activity and thanks to the SBA approval obtained in 2021 for the label expansion for the product that has differentiated it is the first and only human rabies immunoglobulin available in the U S.
All kids to be clinically studied in children.
Our future prospects for further enhancing late August when we received shareholder approval and then close the previously announced $60 million private placement with a female opportunity funds, the leading private equity firm in Israel and allows existing common shareholders.
Speaker 3: Our future prospects were further enhanced in late August when we received shareholder approval and then closed the previously announced $60 million private placement with the FIMI Opportunity Fund, the leading private equity firm in Israel, and a large existing Kamedah shareholder.
Speaker 3: This strategic investment provides us with the financial flexibility, allowing us to accelerate the growth of our existing business and pursue compelling business development.
These strategic investments provide us with the financial flexibility, allowing us to accelerate the growth of our existing business and pursue compelling business development opportunities.
Speaker 3: While Jaime will discuss the next process from the private placement in more detail shortly, I would like to highlight that as a result of this transaction, we are also able to take down the entire remaining outstanding balance of our existing bank loan and we are now debt free.
Well Jaime will discuss the net profit from the private placement in more detail shortly I would like to highlight that the result of this transaction. We are also able to pay down the entire remaining outstanding balance.
Listing bank loan and we are now debt free.
Speaker 3: Moving on, our US team established in 2022 continues to achieve steady progress in promoting of specialty IDG portfolio to physicians and other healthcare practitioners throughout direct engagement and opportunities with medical needs.
Moving on our U S team established during 2022 continues to achieve steady progress promoting our specialty IGT portfolio to physicians and other healthcare practitioners throughout direct engagement and opportunities at medical meetings.
Speaker 3: As we said previously, our activities promoting these important therapies, primarily Cytogum and Varizig, represent the first time in over a decade that these hyperimmunoglobulins specialty products have been supported by field-based activity in the U.S.
And we have said previously our activities promoting these important therapies, primarily sited and vibrancy.
The first time in over a decade, because this hyper immune globulins specialty product have been supported by field based activity in the U S.
Speaker 3: We are excited about the future growth potential of Cytogam and are pleased to report that Cytogam manufactured at our Igloolik facility is now available for commercial sale in the U.S.
We are excited about the future growth potential of site to come and are pleased to report that site to come into effect.
The facility is now available for commercial sale in the U S. Please.
Speaker 3: Please follow the previously received FDA approval of the technology transfer process of CytoGram from its previous manufacturer, CSL Berry.
This follows the people to receive FDA approval of the technology transfer process of cycle come from its previous wouldn't affect Sorel CSL behring.
Speaker 3: The availability of COVID-19 in Canada is expected before the US.
We have an ability of Colorado and effective factored them in Canada is expected to be full by year end.
Speaker 3: We have also recently established our first scientific advisory board consisting of eight US-based world-renowned thought leaders in the solid organ transportation field.
We have also recently established our first scientific advisory board consisting of a U S based well do we know in 40 years in the solid organ transplantation field.
Speaker 3: The advisory board focused on our newly implemented U.S. clinical program for cytokine, including new opportunities and future research and development possibilities.
The advisory both Fuckwits Pheno and newly implemented U S clinical program for <unk>, com, including new opportunities and future research and development possibilities.
Speaker 3: As we said, will be the case, key US traditions are beginning to proactively support the use of this product, starting with Cytogram, which was the subject of a presentation at the recently held ID week 2023 in Boston.
As we said would be the case key U S. Depletions are beginning to proactively support the use of this product starting with cycle, which was the subject of a poster presentation at the recently held I'd be weak 2023 in Boston.
Speaker 3: At this important medical meeting, results were presented of an investigator initiated five-year retrospective study consisting of 325 lung transplant patients evaluating the real-world use of Cytogam in combination with antiviral agents for the prevention of CMV disease in high-risk CMV mismatch lung transplant recipients.
This important medical meeting results were presented of an investigator initiated five year retrospective study consisting of 325 lung transplant patients evaluating the real world use of site to come in combination with the anti viral agents for the prevention of CMV.
<unk> in high risk C N V mismatch lung transplant recipients.
Speaker 3: The presenting KOL, Dr. Fernando Torres, Clinical Chief, Division of Pulmonary and Critical Care at University of Texas Southwestern Medical Center, concluded that the use of proactive multimodality CMV prophylaxis consisting of antivirals and immune augmentation with CMV imoglobulin may improve outcomes among high-risk CMV mismatched lung transplants. Thank you.
The preventive care, well Fernando Torres clinical Chiefs division of pulmonary.
Critical care.
City of Texas Southwestern Medical Center concluded that the use of proactive multi modality CMV prophylaxis, consisting of Antivirals and immune augmentation with C. N V hemoglobin in may improve outcomes among high risk CMV mismatched lung transplant recipients.
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Speaker 3: Moving on, looking farther ahead as future catalysts, we continue to be pleased with the progress made at Commodore Plasma, our U.S.-based plasma collection company. Our 2021 acquisition of a plasma collection center near Houston, Texas, represented Commodore's entry into the U.S. plasma collection market and supported our strategic goal of becoming a fully integrated specialty plasma product company.
Moving on looking further ahead as future catalysts, we continue to be pleased with the progress made it come at the plasma our U S based plasma collection company.
Our 2020, one acquisition of our plasma collection Center in Houston, Texas presented come with its entry into the U S plasma collection market and supported our strategic goal of becoming a fully integrated specialty plasma product company.
Speaker 3: We continue to successfully expand the hyperimmune plasma collection capacity to our first center and we plan on opening our second collection center in Houston, Texas early next year.
We continue to successfully expand the hyper immune plasma collection capacity at our first center in Newtown opening our second collection Center in Houston, Texas early next year.
On the development side enrollment continues to ramp up you know ongoing people.
The phase III.
Clinical trial for inhaled Alpha one antitrypsin therapy for the treatment of Alpha one deficient patients.
Speaker 3: To date, we've enrolled over 30% of the overall required enrollment in the study.
To date, we've enrolled over 30% of the although the required enrollment to the study.
Speaker 3: We have recently also received positive feedback from the independent Data and Safety Monitoring Board, the DSMB, which recommended study continuation without modification for the six times since the study was initiated, based on encouraging safety data observed in the study to date.
We have recently also received positive feedback from the independent data safety monitoring board. The D. S M B, which will command it started continuation without modification for the six times since the study was initiated based on encouraging safety data observed in the studies to date.
Speaker 3: In addition, as we reported on our last call, the European Medicine Agency, the EMA, has recently reconfirmed the overall design of the ongoing study and acknowledged the statistically and clinically meaningful improvement in lung function measured by FED-1 demonstrated in our previous Phase II-III European study.
In addition, as we reported on our last call the European Medicines agency. The EMA cause recently reconfirmed. The overall design of the ongoing study and acknowledge the statistically and clinically meaningful improvement in lung function measured by S&P, one demonstrated the previous phase II.
Three European study.
Speaker 3: We continue to anticipate advancing our discussion with the FDA regarding study progress by end of this year.
We continue to anticipate advancing discussion with the FDA regarding study progress by end of this year.
Speaker 3: As a reminder, Kamada's investigational inhaled AEP treatment is a non-invasive at-home treatment with an expected better ease of use and quality of life for alpha-1 deficient patients as compared to the current IEV standard of care.
As a reminder, Commodore investigational inhaled <unk> treatment, even noninvasive at home treatment with an expected better ease of use and quality of life for Alpha one deficient patients as compared to the current standard of care.
Speaker 3: The in-health product is the leading new innovative alpha deficiency treatment in advanced clinical stage and it represents a substantial opportunity to be a transformational product in the market that is already over $1 billion in annual sales in the US and the EU.
The inhaled products ease of V, leading new innovative alpha one deficiency treatment in advanced clinical stage and each represents a substantial opportunity to be a transformational product in the market because he is already over $1 billion in annual sales in the U S and the EU.
Finally, I'd like to formally welcome professor bathroom in dotcom and Asahi Tyack, well recently appointed as independent directors on our board well circle back is known internationally as one of the most innovative and highly recognized researchers in the field of human Reynolds stem cell.
Speaker 3: And finally, I'd like to formally welcome Professor Benjamin Dekel and Asaf Itchayek, who were recently appointed as independent directors on our board. Professor Dekel is known internationally as one of the most innovative and highly recognized researchers in the field of human renal stem cell biology and regenerative medicine.
Oh Gee.
And regenerative medicine.
Speaker 3: at Mitre Triac, over 15 years of high-tech industry experience in senior management and finance executive positions.
Admittedly, it's higher cause over 15 years of high Tech industry experience in senior management and finance executive positions.
Speaker 3: We look forward to leveraging the scientific and financial expertise of these highly accomplished individuals as we continue advancing our existing business and pipeline and evaluate potential new projects.
We look forward to leveraging the scientific and financial expertise of these highly accomplished individuals as we continue advancing our existing business and pipeline and evaluate potential new opportunities.
Speaker 3: With that, I'll now turn the call over to Jaime for a deeper discussion of our financial results in the third quarter and the first nine months of 2023. Jaime, please go ahead.
With that I'll turn the call over to Jaime for a detailed discussion of our financial results for the third quarter and the first nine months of 2023.
Jaime Please go ahead.
Thank you Amir and good day everyone.
Speaker 4: We're happy to report a significant year-over-year increase in revenues and profitability for the third quarter and first nine months of 2020.
Happy to report the significant year over year increase in revenues and profitability for the third quarter and first nine months of 2022.
Total revenues for the third quarter or approximately $37.9 billion.
Speaker 4: Total revenues for the third quarter were approximately $37.9 million.
Speaker 4: And for the nine months of 2023, total revenues were $106.1 million, an increase of 18% and 26% respectively.
And for the nine months of 2023 total revenues were $106 1 million, an increase of 18% and 26% respectively.
Speaker 4: The year-over-year growth was primarily driven by increased sales of Kedron due to increased demand for the product in the U.S.
The year over year growth was primarily driven by increased sales of catch up catch up due to increased demand for the product in the U S market.
Speaker 4: Total gross profit for the third quarter of 2023 was $14.8 million, representing 39% margins, compared to $12.9 million, or a 40% margin, in the third quarter of 2023.
Total gross profit for the third quarter of 2023 was $14 $8 million, representing 39% margin compared to $12 $9 million or a 40% margin in the third quarter of 2022.
Speaker 4: Total gross profit for the first nine months of 2023 was 41.1 million, representing 39% of Southern California.
Total gross profit for the first nine months of 2023 was $41 1 billion, representing a 39% margin.
Speaker 4: compared to $31.4 million or a 37% margin in the first nine months of 2020.
Compared to $31 $4 million.
Or a 37% margin in the first nine months of 2022.
Speaker 4: As previously discussed, the company is accounting for depreciation expenses associated with intangible assets, which were generated through the late 2021 acquisition of our IGG product.
Previously discussed the company is accounting for depreciation expenses associated with intangible assets, which will generate the late 'twenty or 'twenty, one acquisition of our ITG products.
Speaker 4: The company's cost of goods sold and sales and marketing expenses includes approximately $1.3 million and $400,000 respectively of such depreciation expenses per quarter.
Cost of goods sold and sales and marketing expenses includes approximately $1.3 million and $400000 respectively.
Such depreciation is depreciation expenses per quarter.
Speaker 4: Operating expenses, including R&D, sales and marketing.
Operating expenses, including R&D sales and marketing.
Speaker 4: and other expenses totaled $10.4 million in the third quarter of 2023 compared to $10.3 million in the third quarter of 2022.
G&A and other expenses totaled $10 4 million in the third quarter of 2023 compared to $10 3 million in the third quarter of 2022.
Speaker 4: Operating expenses for the first nine months of 2023 totaled $33.8 million, an increase of approximately 9% over the prior year period. The increase, as compared to 2022, is related to the advancement of our commercial activities, as well as our face-to-face.
Operating expenses for the first nine months of 2020 to me totaled $33 8 million, an increase of approximately 9% over the prior year period the.
The increase as compared to 2022 is related to the advancement of our commercial activities as well as our phase III innovate trial.
As we did throughout 2022, we continue to account for financing expenses with respect to the revaluation of contingent consideration and the long term assumed liability all of which are related to the acquisition completed in 2021.
Speaker 4: Net income for the third quarter of 2023 was approximately $3.2 million, or $0.06 per share on a fully diluted basis, as compared to a net income of $500,000, or $0.01 per share in the prior year.
Net income for the third quarter of 2023 was approximately $3 $2 million or six cents per share on a fully diluted basis as compared to a net income of $500000 or one cents per share in the prior year period.
Speaker 4: Adjusted EB down was $7.9 million for the third quarter of 2023, up 31% as compared to the $6 million in the third quarter of 2022.
Adjusted EBITDA was seven 9 million for the third quarter of 2023 up 31% as compared to the 6 million in the third quarter 2022.
Speaker 4: For the first nine months of 2023, Adjusted EBDA was $17.7 million, up 67% as compared to the $10.6 million in the first nine months of 2023.
For the first nine months of 2000 Twenty's to my adjusted EBITDA was $17, seven, though up 67% as compared to the $10 6 million in the first nine months of 2022.
Speaker 4: As Amir highlighted earlier, we are reiterating our full year 2023 revenue guidance of $138 million to $146 million.
The mere highlighted earlier, we are reiterating our full year 'twenty 'twenty revenue guidance of 138 million to 146 million.
Speaker 4: and adjusted EBDA guidance of $22 million to $26 million.
And adjusted EBITDA guidance of 22 million to 26.
Speaker 4: The midpoint of such range represents approximately 35% growth as compared to fiscal year 2022.
The midpoint of such range represents approximately 35% growth as compared to fiscal year 2022.
Finally cash.
Speaker 4: Cash provided by Operating Activities was $900,000 in the third quarter of 2023 as compared to cash provided by Operating Activities of $5.5 million in the third quarter of 2022.
Cash provided by operating activities was $900000 in the third quarter of 2023 as compared to cash provided by operating activities.
$5 5 million in the third quarter of 2022.
Speaker 4: Our total cash position as of September 30th, 2023 was $52.6 million as compared to $34.3 million on December 31st, 2022.
Our total cash position as of September 32023.
It was $52 $6 million as compared with $34 3 million on December 31st 2022.
This includes $58 2 million of net proceeds from the previously announced $60 million financing, which closed in September of 2023.
Speaker 4: In addition, during the quarter, we paid a total of $17.4 million.
In addition, during the quarter, we paid a total of $17 4 million to close the standing balance of the bank loan.
Speaker 4: to close the outstanding balance of the bank loan.
Speaker 4: and $11.5 million was used for old milestone payments.
And $11 5 million was used for old milestone payments.
Speaker 4: These actions are reflected in our cash balance as of September 30th, 2021.
These actions are reflected in our cash balance as of September 32023.
Speaker 4: Importantly, as Amir noted, we are now debt-free.
Importantly, as Amir noted we are now debt free.
Before proceeding to take your questions.
Speaker 4: I would like to also note that we filed today the notice of the company's annual general meeting to be held on Thursday, December 28. We will now
I'd like to also note that we filed today the notice of the company's annual general meeting to be held on Thursday December 20th.
We will now open the call for questions operator.
Yeah.
Speaker 1: Thank you, sir. Ladies and gentlemen, we will now be conducting the question and answer session.
Thank you, Sir ladies and gentlemen.
Conducting the question and answer session.
Speaker 1: If you would like to ask a question, please press star then 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue.
As a Christian faith space talking one on your telephone keypad.
Automation tone will indicate that the law and he seemed to finish in Q.
He might start two to leave the question Ken.
Speaker 1: For participants making use of speaker equipment, it may be necessary to pick up the handset before pressing the start key.
But like I said, it's making he's a speaker equipment it may be necessary to pick up the handset before pressing the star cage.
Okay.
Speaker 1: Our first question comes from Annabel, from Mimi of Stifle. Please go ahead.
Our first question comes from and if all some Mimi offer stifle Pease go ahead.
Speaker 5: Hi guys, thanks for taking my question and good quarter, so I just want to understand some of the dynamics For kids around you're obviously seeing some very significant growth there Can you tell us it's been approved for some time? So can you tell us what what do you think the key underlying drivers are is it primarily the label change? Is there something else that?
Hi, guys. Thanks for taking my question and good quarter. So I just wanted to understand sort of the dynamics for our country and you're obviously seeing some great growth there.
Can you tell us its been up here for some time. So can you tell us what do you think the key underlying drivers or is it primarily the label change or something else that.
Driving that underlying growth.
Speaker 5: driving that underlying growth, refocus on the sales, can we depend on that consistent growth and those consistent trends going into the next couple of years.
A refocus on the cells.
Yeah.
And on that consistent.
Great.
Going into the next couple of years. Thank you.
Yeah.
Speaker 3: Hi Annabel, thank you for the question. We believe there are multiple dynamics in the market which positively affect the significant growth of the cash market share. It has to do with the level of expansion that we have.
Hi, Annabel. Thank you for the question Yeah, we believe.
Multiple dynamics of the market, which are published positively affect the significant growth of the casual dining market share. It has to do with the label expansion that we have.
Speaker 3: a received and that we have implemented last year or end of 2021.
And receives and that we have in and implemented.
Laughter feel at the end of 2020, one into 'twenty to 'twenty two and then the impact of this you know into 2023 of called the end of the or the pandemic of the fact that you know the overall market has gone back to where it was prior to the pandemic. This also has a significant effect the accident on the wall.
Speaker 3: 2022 and then the impact of this into 2023. Of course, the end of the pandemic and the fact that the overall market has gone back to where it was prior to the pandemic, this also has a significant effect.
Speaker 3: The excellent work done by our partners Cadrion in the U.S. market with a very wide coverage and reaching almost every hospital in America and being able to promote the product and its benefits. Also, there was another product that was in the market until late last year which exited the market and we are able to take a significant market share from that exit of that product.
<unk> done a bio a powerhouse cadre on India, a small cut with a very wide coverage.
Change almost every hospital in America, and being able to promote that.
Product and its benefits and also there was another product that was in the markets until the late class steel, which actually could the market we are able to take it.
So the Mexican market share from that exit of let's say product.
Speaker 5: Great. And anything that you can update us on regarding some pipeline efforts that you have going on?
Okay.
Great and anything that you can update us on regarding some pipeline efforts that you have going on.
Pipeline, that's what that's the question.
Speaker 6: Anything in the pipeline that you have any updates with regard to the clinical studies that you're enrolling right now?
And then anything and in the pipeline that you have any update with regard to the clinical studies that you're enrolling right now.
And as for for E. A T indication or an H. So that says you.
Speaker 6: and for the AT indication or any selections from, you know, early-stage programs that you are willing to go take forward.
You know early stage programs that you are willing to take forward.
Yeah. So so my life what is of course, we're all being held they can I spoke about it on the call. So we are advancing the recruitment for the study and discussing with the regulators and we had a very positive discussion with the EMA. We expect to have a similar discussion with FDA before year end.
Speaker 3: Yeah, so main effort is, of course, around being held at key and I spoke about it on the call. So we are advancing.
Speaker 3: the recruitment to the study and discussion with the regulators and we had a very positive discussion with EMA. We expect to have a similar discussion with the FDA before year-end. We had a successful BS&B meeting recently which has kind of validated the excellent safety process of the product and the safety data that we are accumulating from the current study.
And we had to fix a successful be it shouldn't be a meeting recently, which is kind of validated the excellent safety profile of the product and the safety data that we're accumulating from there from the current study.
Speaker 3: In addition, we do have three early-stage development programs of other plasma-derived products that we have discussed in previous calls. We have a product which is a plasma eyedropper.
In addition, we do have three early stage development programs over other plasma derived product that we have discussed in previous calls we have a product which is a plasma eye drops that is a pre clinical stage, we have an anti <unk> tuberculosis, and even globally in product which is in preclinical.
Speaker 3: that is a preclinical stage. We have an anti-tuberculosis hemoglobin product, which is in preclinical development. And we have a device that we are developing. We call it JetImmune, which is an automated portable small-scale system for extracting and purifying a hyperinumene with rubber lanes from convalescent plasma.
Development and we have a device that we're developing we call. It Jack IMMU, one which is an automated portable a small scale system for extracting purifying, hey, hyperemia and the name of Grumblings from convalescent plasma. So it's those three early stage programs, which are under development.
Speaker 3: So these are the three early stage programs which are under development. Once we make some material progress, we will update all of them in preclinical studies and we hope to start clinical studies in 2025 for the three products.
Once we make some material progress we will update all of their mother and the preclinical.
Studies, and we hope to start clinical studies, they may 2025 for the three products.
Okay, great. Thank you so much.
Thank you, ladies and gentlemen at this change I'm handing over to Japan, which if a patient some of it cost. Thank you.
Speaker 1: Thank you. Ladies and gentlemen, at this stage, I'm handing it over to Brown Ritchie for questions from the webcast. Thank you.
Speaker 2: Thank you. A couple of questions that have come in off the web first.
Thank you a couple of questions.
In off the web but first.
Speaker 2: you know, at various points of the year, as you've already talked about.
You know at various points of the year, which you've already talked about.
Ted Rob has been the driver prior.
Speaker 2: driver. Prior to that, you talked about the four products, the four IGG products being, you know, the primary driver. Seems like there's a lot of diversity in your business, if you will. Maybe, Amir, talk a little bit about that, if you could.
Prior to that you talked about the four products before I G. G products being the primary driver. It seems like there's a lot of diversity in your business. If you will maybe a mere talk a little bit about that if he could.
Speaker 3: Yes, a commonest business is very healthy, if I may use this term. I think we continue to effectively leverage multiple growth.
Yes, a colorado business, he's very very healthy if I may use this with time I think we continue to effectively leverage.
Multiple growth drivers in our business. So as a as we mentioned catch up has been growing significantly with an increase in market share. We also see a nice international growth. So the full FDA approved products required late 'twenty one and.
Speaker 3: in our business. As we mentioned, CareDrop has been growing significantly with an increase in market share. We also see a nice international growth of the four FDA-approved products required, like 21.
Speaker 3: We are investing in the medical, clinical, and commercial activities around cytogram and varizig in the U.S. market with a commercial and medical team we've established in the U.S.
We are investing in the Medicare.
Medical clinical and commercial activities are onsite took them into buy everything in the U S market with the commercial and medical team was established in the U S. And we have always really good solution business, which is growing and so all of that.
Speaker 3: and we have our digital distribution business which is growing. So all of that, if I may, it's like a nice matrix of products and territories that each one of them is contributing to overall growth and looking forward into 2024 and beyond, we expect this growth to continue with the multiple growth drivers that we own.
If I may it's like a nice matrix of products and territories, but each one of them is contributing to our overall growth and looking forward.
Into 'twenty 'twenty, four and beyond we expect this growth to continue with the multiple growth drivers that we own.
Speaker 2: Thanks Amir. Another question that's come in now that the private placement has closed, maybe talk a little bit about what you'll be looking for from a business development standpoint and potentially looking to add.
Thanks Samir.
Another question that's come in now that the private placement has closed maybe talk a little bit about what you'll be looking for from a business development standpoint, and potentially looking to add.
Speaker 3: Yes, so with this fund, thanks to the CIMI investment, we are proactively looking to add some business development initiatives. We are looking to leverage.
Yes, so with the additional funds thanks to the family.
Last month, we are proactively looking.
To add some business development initiatives, we are looking to leverage the commercial end.
Speaker 3: the commercial infrastructure that we have established in the US market to bring in, to acquire or to enlighten the world.
Our infrastructure that we have established in the U S market are.
Two to bring into to acquire in license.
Speaker 3: additional products. This could be either primarily in the transplantation field, where we are currently mainly focused, or specialty plasma products.
Our products are this could be the primarily in the transplantation field, where we are currently mainly focused specialty plasma products.
Speaker 3: And we are, as I mentioned, we are proactively looking for opportunities and we are screening the different assets which are brought to us and hoping that in the future we will be able to close such a transaction which will help us to continue growing the business in addition to the organic growth I just spoke about, so also to grow through M&A.
And we all as I mentioned, we are proactively looking to alternatives and then we are screening the different assets, which are brought to us.
Maybe helping that.
In the future, we would be able to close.
Such a transaction, which will help us to continue growing the business. In addition to the organic growth I just spoke about so also to grow through M&A.
Speaker 2: Terrific. Thank you, Amir. And with that, I'll pass the call back over to you for any closing remarks.
Terrific. Thank you Amir and with that I'll pass the call back over to you for any closing remarks.
Speaker 3: Thank you, Brian . In closing, we are pleased with our solid performance during the first nine months of the year. We are excited about the potential opportunities that Lye had following the closing of the $60 million financing. We look forward to continuing to support clinicians and patients with the important life-saving product that we developed, manufactured and commercialized, and we thank you all, new investors, for their support and remain committed to creating long-term shareholder value.
Thank you Brian So in closing we are pleased with our solid performance during the first nine months of the year. We are excited about the potential opportunities that lie ahead. Following the closing of a 50 million dollar financing, we look forward to continuing to support clinicians and patients with important lifesaving.
A lot of that we developed in the sector and commercialize and we thank you all you investors for their support and we remain committed to creating long term shareholder value. Thank you all and we hope you all stay healthy and safe. Thank you.
Speaker 3: Thank you all and we hope you all stay healthy and safe. Thank you.
Thank you Sir.
Speaker 1: Thank you, sir. Ladies and gentlemen, that concludes today's event. Thank you for joining us. And you may now disconnect your line.
It is unchanged and that concludes today's event. Thank you for joining us and you may now disconnect your line.
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