Financial Data and Key Metrics Changes - Total revenues for the first half of 2025 were $88.8 million, representing an 11% year-over-year increase, while adjusted EBITDA was $22.5 million, up 35% year-over-year, with a 25% margin on revenues [4][11] - For the second quarter, revenues were $44.8 million, up 5% compared to the prior year quarter, and adjusted EBITDA was $10.9 million, up 20% year-over-year [4][11] - Net income for the first half of 2025 was $11.3 million or $0.19 per diluted share, compared to $6.8 million or $0.12 per diluted share in 2024 [13][14] Business Line Data and Key Metrics Changes - Revenue growth for the first half of 2025 was primarily driven by increased sales of Glacier in ex-U.S. markets and VariSig sales in the U.S., as well as Glacier royalty payments [6][7] - The company anticipates launching two additional biosimilars later this year, with expected revenues of approximately $2.5 million in 2025 from the first biosimilar launched in Israel [7][8] Market Data and Key Metrics Changes - The company is ramping up plasma collection at its Texas-based plasma centers, with each center expected to generate annual revenues of between $8 million to $10 million at full capacity [9] - The market for inhaled alpha-one antitrypsin therapy is projected to grow significantly, with expectations that it could reach a $2 billion market by the time the company has results from its study [26] Company Strategy and Development Direction - The company is guided by a four-pillar growth strategy focusing on organic commercial growth, business development and M&A transactions, plasma collection operations, and the advancement of its pivotal Phase III Inhaled AAT program [5][41] - The company is actively conducting due diligence on several potential commercial targets to enrich its portfolio and expects to secure compelling in-licensing collaborations or M&A transactions [8][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continuing to generate profitable growth through the remainder of 2025 and has increased its adjusted EBITDA guidance to between $40 million to $44 million [5][14] - The company is closely monitoring the evolving tariff situation, assessing that recently imposed tariffs are not applicable to drug products and have not impacted operations [15] Other Important Information - The company ended the first half of 2025 with a cash balance of $66 million, which is planned to be used for new business development initiatives [14] - Gross profit for the first half of 2025 was $39.7 million with a gross margin of 45%, compared to $35.7 million and 45% in 2024 [12] Q&A Session Summary Question: Dynamics behind KEDRAB and Cytogam - Management indicated that KEDRAB and Cytogam are performing according to expectations, with growth anticipated once additional clinical data is available [17][19] Question: Cash position for impactful business development - Management plans to utilize existing cash and has additional funding sources available for commercial stage assets, focusing on plasma-derived products and specialty pharma [22][23] Question: Competitive landscape for inhaled AAT program - Management noted that their inhaled AAT program is the most advanced in terms of efficacy studies, with a growing market and multiple new technologies being developed [24][26] Question: Distribution revenue segment and future outlook - Management confirmed that the revenue from the new biosimilar product is not a one-time sale and expects continued growth in the distribution channel [30][31] Question: SG&A expenses and future expectations - Management stated that they have been disciplined in managing expenses and anticipate a slight fluctuation in the second half of the year but aim to maintain profitability [33][34] Question: Tax rate expectations - Management expects an effective tax rate between 20% and 25% as the company utilizes its tax loss carryforwards [35][38]

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]