Financial Data and Key Metrics Changes - Total revenues for the first nine months of 2025 were $135.8 million, representing an 11% year-over-year increase [4][10] - Adjusted EBITDA was $34.2 million, up 35% year-over-year, with a 25% margin on revenues [4] - Net income for the first nine months of 2025 was $16.6 million, or $0.29 per diluted share, up 56% compared to the first nine months of 2024 [12] Business Line Data and Key Metrics Changes - Revenue growth was primarily driven by increased sales of Glassia in ex-U.S. markets, particularly in Latin America and the CIS region [5] - The anti-CMV immunoglobulin Cytogam is undergoing a comprehensive post-marketing research program to demonstrate its advantages [6][31] - The company launched its first biosimilar product in Israel, expected to generate approximately $2.5 million in revenues in 2025, with plans for two additional biosimilars [7] Market Data and Key Metrics Changes - The company has a significant market share in the U.S. for its anti-rabies immunoglobulin Kamrab, with a firm commitment for minimum orders through 2027 [4] - Sales of Cytogam have been below expectations due to inventory management and fewer transplants performed in some hospitals [33] Company Strategy and Development Direction - The company is guided by a four-pillar growth strategy, including organic commercial growth, business development, M&A transactions, plasma collection operations, and advancing its inhaled AAT program [4][39] - Active due diligence is being conducted over several potential commercial targets, with expectations to secure transactions in early 2026 [8][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continuing to generate profitable growth through the remainder of 2025, reiterating annual revenue guidance of $178 million-$182 million [4] - The company is addressing challenges in the Cytogam market and expects resumed growth in the coming months [33] Other Important Information - The Houston plasma collection facility has received FDA approval, with expectations for the San Antonio site to follow in early 2026 [9] - Each plasma collection center is expected to generate annual revenues of $8 million-$10 million at full capacity [9] Q&A Session Summary Question: Details on the Cytogam study and its differences from previous clinical data - The SHILD study will test Cytogam's use in late CMV after antiviral treatment, differing from its current prophylactic use [15][16] Question: Enrollment status for the ATD treatment - Enrollment is at 60-65%, with completion expected by early 2027 and top-line results anticipated in H1 2029 [18][20] Question: Performance of the distribution business - The distribution business has seen actual usage growth, with expectations for continued growth due to a richer product portfolio [24] Question: Plasma collection relative to proprietary product needs - Currently, the majority of plasma collected is normal source plasma, with plans to increase specialty plasma collection over time [25][26] Question: Interim data release for the ATD treatment clinical trial - Results from the interim analysis will be shared through a press release before the end of the year [27][28] Question: Performance of Cytogam and growth drivers - Cytogam sales have been below plan due to inventory management and fewer transplants, but growth is expected to resume [31][33] Question: Future of Glassia royalties - Royalties from Glassia are expected to be above $10 million in 2026, with single-digit growth anticipated thereafter [34][35] Question: Current business development activities - The company is conducting thorough due diligence for potential transactions, with expectations for successful integration of new assets [36][37]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $44 million, representing a 17% increase year over year from $37.7 million in Q1 2024 [4][11] - Adjusted EBITDA for Q1 2025 was $11.6 million, a 54% increase from $7.5 million in Q1 2024 [4][13] - Net income for Q1 2025 was $4 million, or $0.07 per share, up 67% from $2.4 million, or $0.04 per share, in Q1 2024 [13] Business Line Data and Key Metrics Changes - Growth was primarily driven by increased sales of Glacia and Kamrab in ex-U.S. markets, as well as Varezig sales and Glacier royalties income [5][11] - Gross profit for Q1 2025 was $20.7 million with a gross margin of 47%, compared to $16.7 million and 44% in Q1 2024 [12] Market Data and Key Metrics Changes - The company expects to launch two additional biosimilars later in 2025, following the successful launch of its first biosimilar in Israel, which is projected to generate approximately $2 million in revenue this year [8] - The plasma collection operation expanded with a new center in San Antonio, Texas, expected to contribute annual revenues of $8 million to $10 million once at full capacity [9][10] Company Strategy and Development Direction - The company is focused on a four-pillar growth strategy: organic commercial growth, business development and M&A, plasma collection operations, and advancing the Phase III inhaled Alpha-one program [6][39] - A comprehensive post-marketing research program for Cytogam was initiated, consisting of 10 studies aimed at enhancing CMV disease management [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued profitable growth throughout 2025, reiterating annual revenue guidance of $178 million to $182 million and adjusted EBITDA guidance of $38 million to $42 million [5][6] - The company is monitoring the impact of tariffs and NIH spending cuts but does not anticipate a direct impact on its business at this time [21][31] Other Important Information - The company is currently at around 55% enrollment for the INNO2VATE clinical trial and expects to conduct an interim futility analysis by the end of 2025 [26][10] - The tax rate reported for the quarter was 40%, compared to 3% a year ago, but this was attributed to changes in fair tax liability with no cash effect [33][34] Q&A Session Summary Question: Growth contributors for Cytogam - Management clarified that while Cytogam is a growth contributor, the significant growth came from other products in the portfolio [15][17] Question: Impact of tariffs on global business - The CFO indicated that there should be no direct impact on sales from tariffs, but the situation will be monitored [21][24] Question: Timing of Cytogam post-marketing study completion - The CEO mentioned that the comprehensive program spans approximately four years, with some results expected as early as late 2025 [30] Question: Impact of NIH spending cuts - Management does not expect NIH spending cuts to impact the business due to the unique nature of its products [31] Question: Future tax rates - The CFO noted that tax rates may fluctuate through 2025 but expect to have a clearer effective tax rate by the end of the year [34]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $44 million, representing a 17% increase year over year from $37.7 million in Q1 2024 [4][11] - Adjusted EBITDA for Q1 2025 was $11.6 million, a 54% increase compared to $7.5 million in Q1 2024 [4][13] - Net income for Q1 2025 was $4 million, or $0.07 per share, up 67% from $2.4 million, or $0.04 per share, in Q1 2024 [13] Business Line Data and Key Metrics Changes - Growth was primarily driven by increased sales of Glacia and Kamrab in ex-U.S. markets, as well as Varezig sales and Glacier royalties income [5][11] - Gross profit for Q1 2025 was $20.7 million with a gross margin of 47%, compared to $16.7 million and 44% in Q1 2024 [12] Market Data and Key Metrics Changes - The company expects to launch two additional biosimilars later in 2025, following the first biosimilar product launch in Israel, which is projected to generate approximately $2 million in revenue this year [8] - The plasma collection operation expanded with a new center in San Antonio, Texas, expected to contribute annual revenues of $8 million to $10 million [9][10] Company Strategy and Development Direction - The company is focused on a four-pillar growth strategy: organic commercial growth, business development and M&A, plasma collection operations, and advancement of the inhaled Alpha-one program [6][39] - A comprehensive post-marketing research program for Cytogam was initiated, consisting of 10 studies aimed at advancing CMV disease management [6][7] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued profitable growth throughout 2025, reiterating annual revenue guidance of $178 million to $182 million and adjusted EBITDA guidance of $38 million to $42 million [5][6] - The company is monitoring the impact of tariffs and NIH spending cuts but does not anticipate a direct impact on its business [21][31] Other Important Information - The company is currently at around 55% enrollment for the pivotal Phase III INNO2VATE clinical trial for inhaled alpha-one antitrypsin therapy [26] - The tax rate reported for the quarter was 40%, compared to 3% a year ago, with expectations of fluctuations in tax expenses through 2025 [33][34] Q&A Session Summary Question: Growth contributors and Cytogam investment - Management clarified that Cytogam did not significantly contribute to growth this quarter, with the increase coming from other products [15][18] Question: Updates on CMV guidelines - Management indicated that new clinical data from ongoing studies could lead to updates in CMV management guidelines [19][20] Question: Impact of tariffs on global business - Management stated that there should be no direct impact on sales from tariffs, but they will continue to monitor the situation [21][24] Question: Timing of Cytogam post-marketing study completion - The comprehensive program is expected to span around four years, with some results available as early as late 2025 [30] Question: Impact of NIH spending cuts - Management does not anticipate any impact from NIH spending cuts on the business [31] Question: Tax rate changes - The tax rate change was due to shifts between deferred tax assets and liabilities, with expectations of a clearer effective tax rate by the end of 2025 [33][34] Question: Annual guidance implications from strong Q1 - Management will monitor progress in Q2 and may update guidance if strong performance continues [37]