Financial Data and Key Metrics Changes - For the full year of 2025, total adjusted constant currency revenue growth was 13% and adjusted EBITDA growth was 26% year-over-year, resulting in positive free cash flow while investing significantly in future growth [5][15] - Total adjusted revenues for Q4 of 2025 were $118.3 million, up 18.5% compared to Q4 of 2024, with adjusted EBITDA increasing approximately 29% from $17.6 million to $22.7 million [15][16] - Adjusted EBITDA margin was 19.2% in Q4 of 2025, an improvement of approximately 110 basis points over the prior year [16] Business Line Data and Key Metrics Changes - Stent graft revenues grew 36% on a constant currency basis in Q4 compared to the same period last year, driven by AMDS in the U.S. and strong international growth [6][19] - On-X revenues increased 24% year-over-year on a constant currency basis, supported by global market share gains and new U.S. market opportunities [7][8] - Tissue processing revenue increased 6% year-over-year on a constant currency basis, while BioGlue revenues were flat compared to the same period last year [8][19] Market Data and Key Metrics Changes - Revenues in Asia Pacific increased 32%, North America increased 18%, EMEA increased 17%, and Latin America increased 9% compared to Q4 of 2024 [20] - Q4 gross margins were 63% in both 2025 and 2024, with the 2024 gross margin negatively impacted by an idle plant charge due to a cybersecurity incident [20] Company Strategy and Development Direction - The company plans to replicate its proven strategy by introducing additional stent graft products already generating revenue in Europe to the U.S. and Japan, aiming to expand the total addressable market [7] - Future growth is expected to be driven by AMDS commercialization in the U.S., On-X heart valve data, NEXUS PMA, and the ARTISAN IDE trial [32][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in delivering sustainable double-digit revenue growth and driving EBITDA margin expansion, with expectations for constant currency growth between 10%-14% for 2026 [23][26] - The company anticipates challenges in the second and third quarters of 2026 due to tougher comparisons and recovery of the tissue backlog [25] Other Important Information - The company recorded a $2.3 million adjustment to revenue for estimated payback obligations due to Italian government legislation, which has been excluded from adjusted revenue [17][18] - Free cash flow for the full year was approximately $1 million, despite significant investments in the business [22] Q&A Session Summary Question: Impact of Italian clawback on growth - The Italian clawback was specific to the EMEA line and did not impact major product lines, thus not skewing growth rates [36][38] Question: Commentary on AMDS sell-in versus sell-through - Management does not typically break out details on AMDS revenue but noted that implantations are continuing to grow positively [40][41] Question: Progress on AMDS target accounts - The company is in the early stages of AMDS rollout, with significant opportunities to open new accounts and increase implants in existing accounts in 2026 [44][45] Question: Market opportunity for NEXUS - The NEXUS device is positioned in a nascent market with a $150 million U.S. opportunity, and the company believes it is well-positioned against competitors [46][48] Question: Pricing for AMDS and NEXUS - The company sees strong demand for AMDS and NEXUS at their current price points, supported by favorable reimbursement dynamics [54] Question: CapEx plans for 2026 - CapEx is expected to be approximately $50 million in 2026, primarily for capacity expansion and IT system improvements [71][72]

Financial Data and Key Metrics Changes - Product sales for Q4 2025 were $7.6 million, a decrease of 1.6% compared to Q4 2024, with domestic sales growing 8.7% to $7 million [12][13] - Full-year product sales for 2025 totaled $27.6 million, reflecting a growth of 4.3% compared to 2024 [14] - A non-cash impairment write-down of approximately $2.9 million is expected due to the shift in strategy regarding Re-Tain [15] Business Line Data and Key Metrics Changes - The First Defense product line saw a significant growth of 41.3% in Q4 2025 compared to Q4 2024, indicating strong demand [5] - There is a noted shift towards the Tri-Shield product within the First Defense suite, reflecting a migration from Dual-Force products [14] Market Data and Key Metrics Changes - Domestic sales showed an increase of 8.7%, while international sales declined by 52.6% in Q4 2025, primarily due to order timing in Canada [13][14] - The total addressable market for First Defense is estimated to be approximately $900 million worldwide, driven by increased calf values and the need for early-life calf health solutions [8] Company Strategy and Development Direction - The company is shifting its strategic focus to prioritize First Defense, pausing investments in Re-Tain due to regulatory challenges and a high confidence in First Defense's growth potential [6][7] - Plans include expanding the sales team by 50% and creating two new U.S. sales territories to drive growth in First Defense [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the future sales and profit growth potential of First Defense, emphasizing the importance of operational excellence and capacity expansion [17][18] - The company is optimistic about the ongoing investigational studies for Re-Tain, which are expected to provide valuable data for future partnerships [41] Other Important Information - The company is repurposing manufacturing assets from Re-Tain to support First Defense, which is expected to enhance production capacity without significant additional capital [6][11] - A write-down of approximately $600,000 is planned for inventory deemed unsuitable for requirements [16] Q&A Session Summary Question: Impact of regional pathogens on foreign sales development - Management acknowledged the complexity of international sales and the need for experienced personnel to navigate product requirements and market strategies [22] Question: Explanation for contract manufacturer's failure to comply with FDA requirements - Management declined to provide details but confirmed that the Incomplete Letter from the FDA was solely due to issues with the contract manufacturer [24][25] Question: Timeline for securing a strategic partner for Re-Tain - Management expressed confidence in the product's capabilities and indicated that they would seek partnerships after completing investigational studies in 2026 [28][41] Question: Clarity on the self-imposed milk discard period for Re-Tain - Management clarified that the discard period is necessary to avoid impacting cheese production, but it is still less than competitors' requirements [47][48] Question: Explanation for exceeding sales expectations - Management attributed the sales exceeding expectations to effective management practices and a strong commercial team, despite complexities from previous backorder situations [54][55]

Just a short time ago, President Trump announced a new change on cannabis policy. In an executive order signed this afternoon, the president laid out his intention to reclassify cannabis under the Controlled Substances Act. Right now, cannabis is a schedule one substance along with drugs like heroin, LSD.Under the law, these drugs are considered to have the highest potential for abuse and no medical use. Under the executive order, cannabis would now become a schedule three substance, falling into the same c ...

All right, so we're coming off last week, two weeks of gains and a lot of it was that PC on Friday at least that kind of kept us going. Y the fact that inflation came in just a tick lower giving people confident about the Fed rate cut. What areas of the market does that make you bullish on.>> So a lot of what I've been talking about for a while is focusing on down on the market cap spectrum. So look at those small and mids and these are exactly the companies that are going to benefit the most for this kind ...

RT Charles Gorrivan (@CGorrivan)Two GOP lawmakers were invited to an FDA approval meeting involving Patrick Soon-Shiong’s Anktiva, an unusual step for an agency meant to stay apolitical. Officials “forcefully” objected and the plan was dropped. Scoop w/ @rachelcohrs and @gerryfsmith. https://t.co/fO90P6PRPI ...

RT Thomas Brewster (@iblametom)🚨NEW🚨 A couple made millions from an anti-choking device that sucked objects out of throats, claiming it was FDA-approved.But the FDA had told them to stop selling it.Meanwhile, similar devices were on Amazon up until this week when I flagged them.https://t.co/3yuenho1sV ...

Company Overview - Kura Oncology is preparing for the FDA approval of ziftomenib, with a PDUFA date set for November 30, indicating confidence in obtaining a competitive label for relapsed/refractory NPM1-mutant AML [3]. Product Development - The company has received positive feedback from key opinion leaders (KOLs) regarding the efficacy, simplicity, compatibility, and safety of ziftomenib compared to competitors [3]. - Kura's commercial team is fully established and ready for market access and preapproval information exchanges [3]. Future Prospects - Kura Oncology is also advancing ziftomenib in combination with standard treatments for frontline indications, indicating a strategic focus on expanding its therapeutic applications [4].

Technology & Procedure - Hystotripsy, utilizing targeted ultrasound waves, offers a non-invasive method for tumor destruction [2] - The Edison system by HystoSonics is currently the only commercially available hystotripsy machine for human use [2] - Hystotripsy mechanically destroys tumor cells by rapidly expanding and contracting gases within them, liquefying the tissue instantly [7] - The procedure typically takes 1 to 3 hours, depending on the number of tumors targeted [18] Clinical Trials & Applications - Hystotripsy received FDA approval in October 2023 and is expanding availability [20] - While primarily focused on liver tumors, hystotripsy has potential applications for tumors in other organs [13] - Trials are underway for kidney and pancreatic tumors, with US availability for pancreatic tumor treatment expected in 2026 [15][16] - Future trials may explore applications for prostate (BPH and cancer), uterine fibroids, breast tumors, thyroid nodules, and even brain tumors [17] Post-Procedure & Immune Response - Most patients can return home a few hours after the procedure [19] - The body's immune system naturally absorbs the liquefied tumor [11] - Animal studies suggest hystotripsy may offer a systemic immunologic benefit by exposing hidden tumor antigens to the immune system [11][12]

Core Insights - Arquitos Capital Management reported a net return of 13.1% for Q2 2025, with year-to-date gains reaching 28.8% as of June 30, 2025 [1] Company Overview - Liquidia Corporation (NASDAQ:LQDA) is a biopharmaceutical company focused on developing, manufacturing, and commercializing products for unmet patient needs in the U.S. [2] - As of September 22, 2025, Liquidia's shares closed at $22.90, with a market capitalization of $1.922 billion [2] Stock Performance - Liquidia's stock experienced a decline of 19.40% over the past month, but it gained 120.85% over the last 12 months [2] - Following the FDA approval and launch of its flagship drug Yutrepia, Liquidia's stock price fell from over $19 in early June to $12.46 by the end of Q2 2025, attributed to investor concerns regarding the commercial rollout and potential competition [3] Product Launch and Market Position - The launch of Yutrepia is critical for Liquidia, as it aims to penetrate a previously monopolistic market [3] - Despite challenges such as patent disputes and FDA approval delays, Liquidia's shares have increased by 200% compared to the original purchase price over three years [3]

Clinical Trial Results & FDA Approval - Lilly's oral pill data for obesity and Type 2 diabetes initially caused significant market disappointment [1][2] - The recent data is viewed as the final step before submitting plans to the FDA for approval of the pill [2] - FDA approval is anticipated no earlier than 2026 [4] Market Expectations & Potential - Long-term expectations for the pill have decreased due to weight loss percentage and gastrointestinal side effects [3] - Despite lowered expectations, the pill is still projected to become a multi-billion dollar product in the US market [3] Side Effects & Advantages - The pill's side effects include diarrhea, nausea, and gastrointestinal issues, comparable to other medications like Wegovy [5] - The primary advantage of the pill is its convenience as a once-daily oral medication compared to weekly injections [6]