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| We also continue to be pleased with the progress achieved at Kamada Plasma, our US-based plasma collection company |
| 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 |
| 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 opportunity |
| We believe the continuation of this partnership maximizes the future growth and value potential of this important product |
| Importantly, we are well positioned for further top and bottom line growth this year |
| With total revenues of $142.5 million, which represented year-over-year growth of 10%, and EBITDA of $24.1 million, an increase of 35% as compared to the 12 months ended December 31, 2022, we achieved the top and the bottom line growth anticipated in our business during 2023 |
| We continue to effectively leverage the growth drivers in our business, focusing on the significant increase in KEDRAB US market share and the promotion of CYTOGAM in the US market |
| And is that going to be accepted by the EU as well? Amir London In general, I just want to start saying that we were very pleased with the positive feedback from the FDA |
| And we have a very robust safety data, which really satisfied the agency and waived additional requirements for safety evaluation |
| Additionally, I would like to highlight our strong balance sheet |
| As previously highlighted, our business performed extremely well in 2023 |
| 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 market and commercial capabilities and resources |
| As Amir highlighted earlier, we anticipate continued momentum through 2024 with double digits top and bottom line growth |
| The substantial market share growth demonstrated by KEDRAB is being driven by Kedrion's extensive market coverage and robust commercial activity as well as FDA approval for label expansion for the product obtained in 2021 that has differentiated it as the first and only human rabies immunoglobulin available in the US to be clinically studied in children |
| First, what could a potential partnership for an inhaled AAT look like? Amir London Building on what I just answered Annabel on the previous question, we believe that inhaled alpha-1 has significant advantages |
| So, in terms of cost of goods and potential competitiveness, we also have significant advantage |
| So in closing, we're very pleased with our exceptional performance during 2023, and excited about the potential opportunities that lie ahead based on the amended KEDRAB agreement, existing ongoing late stage inhaled alpha-1 clinical program, and the strength of our commercial portfolio and balance sheet |
| The inhaled product is a leading new innovative alpha-1 treatment in advanced clinical stage and it represents a substantial opportunity to be a transformational product in a market that is already over $1 billion in annual sales in the US and the EU |
| To reiterate what we have said previously, Kamada's investigation on 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 current IV standard of care |
| And we believe that if it makes it to the market, it's going to be a transformational product that is going to compete very well in the markets |
| So this is a very positive sign |
| In terms of inhaled, we believe inhaled has significant advantages in general |
| So, like a powerhouse like Sanofi being active in the alpha-1 space will definitely going to significantly increase the market in general by better diagnostics and better coverage |
| We believe that if the product will make it to the market, Sanofi, with their significant marketing and promotional power, will create better awareness and greater awareness to alpha-1 deficiency |
| Looking ahead, we expect the momentum generated last year to extend through 2024, with full year revenue and profitability to be meaningfully increased as compared to 2023 |
| 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 |
| So we believe we have sufficient advantages, significant advantages [indiscernible] market is going to be a highly competitive product |
| We continue to successfully expand the high premium 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 |
| Torres concluded that the use of proactive multimodality CMV prophylactic consisting of antivirals and immune augmentation with CMV immunoglobulin may improve outcomes among high-risk CMV mismatch lung transplant recipients |
| Moving on, our US team, established in 2022, continues to achieve steady progress in promoting our specialty IgG portfolio to physician and other health care practitioners through direct engagement and opportunities at medical meetings |
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| Revaluation of contingent consideration and the long-term assumed liabilities totaled $1 million during 2023, significantly lower than in 2022 |
| As you may know, majority of the alpha-1 patients are still misdiagnosed or undiagnosed |
| Net income for the fiscal year 2023 was $8.3 million or $0.15 per diluted share as compared to the net loss of $2.3 million or a loss of $0.05 per share recorded in 2022 |
| Such decrease was associated with a temporary reduction of CYTOGAM sales during 2023 |
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