Kamada Ltd.

Greetings. Welcome to the Kamada Limited third quarter 2022 earnings conference call. This time, all participants are in listen-only mode. Any question and answer session will follow the formal presentation. If anyone today should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. At this time, we'll turn the conference over to Bob Yedid of LifeSci Advisors. Bob, you may now begin.

Rob, thank you very much. This is Bob Yadid from Westside Advisors. Thank you all for participating in today's call. Joining me from Comida are Amir London, Chief Executive Officer, and Jaime Orlev, Chief Financial Officer. Earlier today, Comida announced its financial results for the three and nine months ended September 30th, 2022. If you have not received this news release, please go to the investors page of the company's website at www.comeda.com. If there are any questions at the end of this call, please feel free to email your questions to ir.comeda.com. Before we begin, I'd like to caution that comments made during this conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Comeda. I encourage you to review the company's filings with Securities and Exchange Commission, including without limitation the company's forms 20F and 6K, which identify specific risk factors which may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast Tuesday, November 22nd, 2022. Comida 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 Lundin, Chief Executive Officer. Amir.

Thank you, Bob. My thanks also to our investors and analysts for your interest in Kamada and for participating in today's call. I'm pleased to report Kamada's strong third quarter performance, which demonstrates the successful strategic transition of the company and is consistent with our previously communicated positive outlook. You will recall that we had forecasted that our financial results in the second half would meaningfully improve as compared to the last year and the first six months of this year. Our performance in the third quarter indicates that our business is beginning to realize the significant benefits of the acquired portfolio of four FDA-approved IGGs, consisting of Cytogam, Hepagam, Varizig, and Winro. In fact, I can now confidently say that we have completed our rapid transition from our past dependency on Glacier Cell to Takeda, into a diversified, fully integrated commercial company and a global leader in the plasma-derived specialty markets. On our last call, I laid out our expected key sales and profitability drivers for the second half of the year. This included our IGG portfolio, sales of CADRA to CADREON, and Glacier Royalty Income. All of these were indeed important contributors to our sales and profitability growth in the third quarter, in which we generated total revenues of $32.2 million, representing a 40% increase year-over-year, and growth margins of 40%, up from the 25% in the third quarter of 2021 and 31% in the second quarter of 2022. Our adjusted EBITDA for the third quarter was $6 million, representing a 19% margin. and for the first nine months of the year, adjusted EBITDA was $10.6 million, representing a 13% margin. This EBITDA level is consistent with our annual guidance, and it represents a 58% increase as compared to last year. We also continue to generate positive cash flow from operating activities for the third consecutive quarter, resulting in a cash position of $31.3 million as of September 30, 2022. This significant cash generation is indicative of our profitable commercial operations. We expect to report further sales growth and enhanced profitability in the fourth quarter, and as a result, we are reiterating our full-year 2022 revenue guidance of between $125 to $135 million, with expected EBITDA margins of 12% to 15%. This guidance represents a 20% to 30% increase over 2021 revenue. It will be more than 2.5 times 2021 EBITDA. Looking further ahead, we continue to forecast growth at a double-digit rate in the foreseeable years beyond 2022. The portfolio of the four FBA approved in the Global LIMS we acquired late last year continues to gain traction in multiple markets and again delivered strong sales and profitability for Kamada during the third quarter. As a reminder, the acquired product generated collective revenues of approximately $42 million in 2021 with over 50% gross margins and we anticipate that we will significantly grow the new portfolio revenues year over year, beginning already this year. I'm pleased to report that in recent months, as part of the establishment of our direct presence in the U.S. market, we deployed a team of U.S.-based experienced cells and medical affairs professionals who rapidly established our operation in this key market. The U.S. cells team is making good progress in promoting our portfolio of specialty plasma-derived to physician and other healthcare professionals to direct engagement and opportunities at medical meetings. Our medical affairs team is working to educate physicians while addressing the scientific and clinical inquiries. Throughout 2022, our team participated and presented at major medical conferences in the U.S., including International Society of Heart and Lung Transplants, American Transplant Congress, and the American Association for the Study of Liver Disease. This area of activities represents the first time in over a decade that these high premium products have been supported by field-based activity in the U.S. We are encouraged by the positive feedback received from key U.S. physicians who are seeking to publish new clinical data related to our portfolio while conducting educational symposium that we believe will have a positive impact on understanding of these products, contributing to continued growth in demand. Outside the U.S., we continue to generate meaningful sales growth from these products in the international markets. I would highlight the recently signed $11.4 million agreement to supply Varizig, one of the four products, to an international organization operating principally in Latin America. This agreement will be a key driver for us in the fourth quarter, as approximately half of the anticipated revenues to be generated by this agreement are expected during this period, while the balance will be extended to the first half of 2023. From a strategic standpoint, this important supply agreement strongly validates our ability to grow the sales of our newly acquired portfolio in the different international markets. In addition, We recently secured a second significant tender with extension of an existing supply agreement from the Canadian Blood Services, CBS, for the supply of all four products for an additional three years for an approximate total value of $22 million. This award secures the ongoing sale of those products in the Canadian market. CBS manages the Canadian supply of blood products for all Canadian provinces and territories excluding QIPEC. The extension with CBS is for a three-year period, commencing on April 1, 2023, with an option to extend for up to two additional years. We are continuing to pursue additional commercial contracts in key strategic territories and are highly encouraged by the significant opportunities ahead of us. These supply agreements and our proactive selling efforts through our long-standing distribution relationship underscore Commodore's firm commitment to leveraging these new strategic assets. I should also add, as we continue to expect, receipt of FDA approval for the manufacture of Cytogram, the largest of the four acquired products, at our Israeli facility during the first half of 2023. Let's move on to CADRAP, our rabbit in the globally. Based on the continued moderation of the COVID pandemic in the U.S. and increased travel and outdoor activities, we remain encouraged by the product in-market sales by CADREON through the first nine months of the year, which again grew significantly during the third quarter in comparison to the pre-COVID pandemic sales levels. We believe the trend will continue and expect CADRAP to be an increasingly important growth driver for us over the next few years, as it continues to gain market share in the $150 million U.S. market. I should highlight that this product also generates more than 50% growth margins for Kamada. Next, we continue to receive royalty income on Glacier sales from Takeda. During the third quarter, we generated royalty income of $3.5 million. As a reminder, Royalty income from Takeda represents pure profit for Kamada, and our Galatia royalty agreement with Takeda extends out to 2040. Now let's look a little further ahead at future catalysts. I begin with Kamada Plasma, our U.S.-based plasma collection company. Our early 2021 acquisition of Plasma Collection Center near 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 remain focused on expanding the high premium plasma collection capacity at this center and continue to advance our plans to open additional centers in the U.S. to further enhance our supply of specialty and normal source plasma. In fact, we're in the process of finalizing the selection of a site in Texas for our second collection center with construction and startup activities to be initiated in the near future. As we have said previously, the planned expansion of our plasma collection capabilities is expected to enhance our IGG competitive position in various markets, boost continued revenue growth, and strengthen our supply chain. Let's now turn to our ongoing Pivotal Phase III Innovate clinical trial that is evaluating the safety and efficacy of an innovative in-health AT product for the treatment of AT deficiency. You will recall that earlier this year, following the moderation of the COVID pandemic, the study was expanded and now includes six sites across Europe. I'm pleased to report that enrollment has recently begun to accelerate. To date, 30 patients were enrolled for treatment, including 14 patients who have already completed the two-year study treatment period at the initial trial site in Leiden, the Netherlands. Importantly, none of those patients discontinued treatment prematurely, and no drug-related serious adverse events were reported. This high level of patient adherence to the treatment is encouraging. Additionally, as part of a routine and planned monitoring process, and for the first time since study initiation, the Independent Data Safety Monitoring Board, the DSMB, recently recommended that the trial continue without modification. Moreover, based on the encouraging safety indicators observed to date, the DSMB supported an expansion of the inclusion criteria to also include subjects with severe airflow limitation. The previous inclusion criteria limited the trial to include only patients with FEV1 between 80 and 50%, but the extended criteria also allows us to include patients with FEV1 over 40%. This important change is expected to further expedite patient enrollment. Importantly, we intend to meet with the FDA and with the EMA through the first half of 2023 to discuss trial progress and explore potential opportunities to shorten the regulatory pathway. As the most advanced investigational product for AT deficiency, a substantial commercial opportunity exists for in-health AT to be a transformational next-generation augmentation therapy in the growing AAT market, which is already over a $1 billion market in annual sales in the U.S. and the EU. In summary, we continue to execute on our corporate strategy on all fronts and believe we have the appropriate catalyst to drive double-digit growth in the foreseeable years ahead of us. We're excited about our near-term prospects, as well as our longer-term outlook, as Canada is uniquely positioned for growth as a global leader in the specialty thousand industry with multiple value-creating milestones expected in the months and the quarters ahead. With that, I now turn the call over to Jaime for his review of our third quarter 2022 financial results. Jaime, please.