Core Insights - The international operations of Avanos Medical are crucial for assessing its financial resilience and growth prospects [1][2][3] Revenue Performance - The total revenue for Avanos Medical in the quarter was $167.5 million, reflecting a year-over-year increase of 0.8% [4] - Revenue from Europe, Middle East, and Africa accounted for 14.15% of total revenue, amounting to $23.7 million, which was a surprise increase of 3.4% compared to analyst expectations [5] - Asia Pacific and Latin America contributed $13 million, or 7.76% of total revenue, representing a surprise increase of 12.07% over expectations [6] Future Revenue Forecasts - For the current fiscal quarter, total revenue is anticipated to be $167.69 million, a decline of 2.3% year-over-year, with expected contributions of 13.9% from Europe, Middle East, and Africa and 7.1% from Asia Pacific and Latin America [7] - The forecast for total revenue for the entire year is $677.36 million, a reduction of 1.5% from the previous year, with expected contributions of 13.8% from Europe, Middle East, and Africa and 7.1% from Asia Pacific and Latin America [8] Market Dynamics - Avanos Medical's reliance on international markets presents both opportunities and challenges, making it essential to track international revenue trends for future projections [9] - Financial analysts are closely monitoring these developments to refine earnings estimations, influenced by various factors including local market status [10]

Core Insights - NeuroOne Medical Technologies Corporation has made significant operational progress with its OneRF® Ablation System, including a successful 510(k) submission to the FDA for the Trigeminal Nerve Ablation System to treat facial pain ahead of schedule [3][6] - The company completed an oversubscribed capital raise of $8.2 million, which is expected to fully fund operations through at least fiscal year 2026 [5][6] - The company anticipates potential revenue generation from the trigeminal nerve ablation as early as late calendar year 2025, contingent upon FDA clearance [4][6] Recent Company Highlights - The OneRF® Ablation System has shown clinical success, with patients remaining seizure-free after treatment [3] - The company has strengthened its management team by hiring Dr. Parag Patil as Chief Medical Advisor and Emily Johns as General Counsel [6] - Significant media interest has been secured, including features on major news outlets [6] Financial Performance - Product revenue for the second quarter of fiscal 2025 was $1.4 million, consistent with the same quarter of the previous year, while for the first six months, it increased by 98% to $4.7 million compared to $2.4 million in the same period of fiscal 2024 [9][10] - License revenue of $3.0 million was recorded in the first six months of fiscal 2025, derived from an expanded distribution agreement with Zimmer [9] - Product gross profit increased to $0.8 million, or 55.6% of revenue, in the second quarter of fiscal 2025, compared to 28.3% in the same quarter of the prior year [10] Operating Expenses and Losses - Total operating expenses for the second quarter of fiscal 2025 were $3.5 million, slightly higher than $3.3 million in the same quarter of the prior year [11] - The net loss improved to $2.3 million, or ($0.07) per share, compared to a net loss of $2.9 million, or ($0.11) per share, in the same quarter of the prior year [12] Future Outlook - The company maintains its fiscal year 2025 product revenue guidance of $8.0 million to $10.0 million, representing an increase of 132% to 190% compared to fiscal year 2024 [15] - Expected product gross margin for fiscal year 2025 is projected to range between 47% and 51%, compared to 31% in fiscal year 2024 [15]

Core Insights - Microbix Biosystems Inc. and Aurevia Oy are launching a pilot external quality assessment program to enhance clinical laboratories' proficiency in diagnosing bacterial vaginosis using molecular diagnostic methods [1][3] - The program aims to provide definitive diagnoses for bacterial vaginosis and other vaginal infections, improving treatment plans and patient care [2][5] Company Overview - Microbix Biosystems Inc. specializes in creating proprietary biological products for human health, with a monthly sales target of C$ 2.0 million or more and a workforce of over 120 employees [6] - The company manufactures critical ingredients and devices for the global diagnostics industry, including antigens for immunoassays and laboratory quality assessment products [6][7] - Microbix is ISO 9001 & 13485 accredited and has a presence in over 30 countries through a network of international distributors [6] Industry Context - Bacterial vaginosis is a common condition affecting a significant percentage of women, traditionally diagnosed through less definitive methods [2] - Molecular diagnostic tests offer a more accurate means of diagnosis by distinguishing the organisms present in vaginal flora [2] - The EQA program will utilize simulated samples created by Microbix to emulate clinical specimens, ensuring safe and stable testing conditions [4][3] Program Details - The pilot program, titled "Bacterial vaginosis and vaginitis multiplex nucleic acid detection," will assess clinical labs' capabilities in diagnosing bacterial vaginosis and other vaginal infections [3] - Microbix has developed three quality assessment products (QAPs) specifically for this pilot, designed to emulate the workflow of molecular diagnostic tests [4] - Following the pilot study, an ongoing program for bacterial vaginosis is expected to be integrated into Aurevia's Labquality EQAS portfolio [3] Leadership Commentary - Aurevia's EQA Solutions Manager emphasized the importance of validating emerging molecular diagnostic tests to improve access to care and ensure accurate diagnoses [5] - The CEO of Microbix expressed pride in collaborating with Aurevia to validate next-generation diagnostic tests, aiming to support clinical labs in achieving high levels of accuracy and quality assurance [5]

Financial Data and Key Metrics Changes - The company reported total revenue of $32.9 million for Q1 2025, an 18% increase from $27.9 million in Q1 2024, primarily driven by growth in the biologics product family [5][12] - Adjusted EBITDA for Q1 2025 was $3 million, compared to an adjusted EBITDA loss of $1 million in Q1 2024 [15] - Net income for Q1 2025 was $58,000, or $0.00 per share, compared to a net loss of $4.4 million, or $0.03 per share, in the same period last year [15] Business Line Data and Key Metrics Changes - The biologics product family experienced significant growth, while spinal implant sales declined by 10% or $1.2 million year over year [12] - The company launched two new innovative products, Trivium and FiberX, aimed at rejuvenating its core demineralized bone offerings [8] - The company anticipates mid double-digit revenue growth in its biologics product family for the fiscal year 2025 [10] Market Data and Key Metrics Changes - The company received royalties from licensing its Simply Max Q code to a distributor in the chronic wound care space, which is expected to generate additional income [9] - CMS has extended the local coverage determination for skin substitutes to December 31, 2025, potentially increasing royalty income [9] Company Strategy and Development Direction - The company has achieved full vertical integration of its biologics products, marking a significant strategic milestone [7] - The focus is on self-sustainability, profitability, and cash generation, with a targeted revenue guidance for 2025 in the range of $127 million to $131 million, representing 8% to 11% growth [11] - The company is rationalizing its hardware product lines to optimize cash management [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's future, emphasizing the importance of being realistic regarding government policy impacts on revenue [22] - The company is focused on maintaining its growth in the biologics sector while managing the transition in its hardware offerings [24] - Management expects steady revenue growth throughout the remainder of the year, with cash flow from operations anticipated to improve in Q4 [27] Other Important Information - The company terminated a restrictive investor rights agreement with OrbiMed, which is seen as a positive development for shareholders [6] - The company has added processing capacity at its Belgrade facility to support growing production needs [9] Q&A Session Summary Question: What are the assumptions for incremental minimum payments and royalties from the Amneal deals? - Management has not included additional minimums under the royalty agreement and assumes full manufacturing under the manufacturing license agreement for the remainder of 2025 [19][20] Question: Can you walk through the different drivers for growth in the biologics business? - Key drivers include growth from Amneal and VBM, with a focus on transitioning customers to new product lines [23][24] Question: How should we think about EBITDA and cash flow through the rest of the year? - Cash flow from operations is expected to be tighter in Q3 but improve in Q4, with steady revenue growth anticipated [27] Question: What is the outlook for sales and marketing expenses? - Sales and marketing expenses are expected to increase in Q2 and beyond, aligning more closely with Q4 of the previous year [32] Question: Will there be margin improvements from in-house production? - Management expects margin improvements from bringing production in-house, particularly for products like Fibrex and Trivium [34][35]

Core Insights - BioStem Technologies, Inc. reported a record first quarter in 2025, with revenue increasing by 73% year-over-year to $72.5 million, driven by strong performance in its wound care portfolio, particularly the Vendaje AC product [2][7][13] - The company is focused on transitioning more customers to Vendaje AC to enhance brand consistency and is also working on reducing selling, general, and administrative expenses by phasing out licensing fees associated with AmnioWrap2 [2][3] - BioStem has received IRB approval for a new clinical trial for its BioREtain Amnion Chorion product aimed at treating venous leg ulcers, marking its third prospective clinical trial [3][4] Financial Performance - Preliminary net revenue for Q1 2025 was $72.5 million, a 73% increase from $41.9 million in Q1 2024 [7][13] - Gross profit reached $71.7 million, representing a gross margin of 99%, compared to 95% in the same quarter of the previous year [7][13] - Operating expenses increased to $66.4 million from $35.1 million in Q1 2024, primarily due to higher sales and marketing costs [7][13] Clinical Trials and Product Development - BioStem launched the BR-AM-DFU clinical trial to evaluate Vendaje for non-healing diabetic foot ulcers, aiming to validate the clinical efficacy of its BioREtain technology [4] - The company has expanded its intellectual property portfolio, holding 55 issued patents and 52 pending patents, reinforcing its innovation leadership in regenerative medicine [5] Market Position and Strategic Focus - The company is actively pursuing an uplisting to Nasdaq and is currently under SEC review regarding its Form 10 registration [2][7] - BioStem aims to strengthen its position in the chronic wound care market while maintaining a focus on clinical evidence to support product adoption [2][3]

Financial Data and Key Metrics Changes - Revenue in Q1 2025 was $896,000, up 39% compared to $647,000 in Q1 2024 [26] - Unit sales increased approximately 46% due to growth from patients with full insurance reimbursement coverage and the company's financial assistance program [26] - Gross margin in Q1 2025 was 84.4%, down from 88.4% in Q4 2024, attributed to a higher growth rate of discounted financial assistance patients [27][28] - Operating loss for Q1 2025 was $2,300,000, an increase of 25% compared to a $1,800,000 loss in Q1 2024 [30] Business Line Data and Key Metrics Changes - Significant growth of 40% in Q3 2024, 43% in Q4 2024, and 39% in Q1 2025 for IV stem technology [9] - 300 patients were treated in Q1 2025, an annualized rate of 1,200 patients, representing only 0.2% of the 600,000 severely affected children in the U.S. [18] - The rectal expulsion device (RED) received FDA clearance and is currently in a soft launch phase [16][21] Market Data and Key Metrics Changes - Total covered lives increased from 4 million a year ago to approximately 51 million today [11] - The company expects to see increased orders following the publication of independent guidelines by the academic society [33][34] Company Strategy and Development Direction - The company is focused on achieving cash flow breakeven and profitability through increased insurance coverage and the effective date of the category one CPT code on January 1, 2026 [25][20] - The strategy includes leveraging strong published data to drive insurance expansion and sustainable revenues [8][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding continued revenue growth due to the expected increase in insurance policy coverage and the category one CPT code [21][25] - The company is cautiously optimistic about the timeline for receiving guidelines and subsequent policy coverage from payers [33][35] Other Important Information - The company settled a lawsuit for $750,000, which will be paid in equal monthly installments starting January 2026 [42] - The legal settlement is viewed positively as it mitigates further risks and legal fees [42][43] Q&A Session Summary Question: When do you expect the guidelines to be published? - Guidelines are expected to be published by the end of the month, with orders anticipated to increase based on policy coverage from those guidelines [33][34] Question: How do you see your operating expenses in the near and medium term? - Operating expenses are expected to increase as investments in sales and marketing are necessary, but as a percentage of sales, they are expected to decrease [36][37] Question: Can you provide more color on RED and its launch? - The response to the RED soft launch has been stronger than expected, with a significant need for the technology noted [38][40] Question: Can you provide details on the legal settlement? - The legal settlement from 2019 will be paid in installments starting January 2026, and it is seen as a positive step for the company [41][42]

Financial Data and Key Metrics Changes - Revenue in Q1 2025 was $896,000, up 39% compared to $647,000 in Q1 2024 [25] - Unit sales increased approximately 46% due to growth from patients with full insurance reimbursement coverage and the company's financial assistance program [25] - Gross margin in Q1 2025 was 84.4%, down from 88.4% in Q4 2024, attributed to a higher growth rate of discounted financial assistance patients [26][27] - Operating loss for Q1 2025 was $2,300,000, an increase of 25% compared to a $1,800,000 loss in Q1 2024 [29] Business Line Data and Key Metrics Changes - The company reported significant growth in the IV stim technology, with a 39% growth in Q1 2025 [9] - The rectal expulsion device (RED) received FDA clearance and is currently in a soft launch phase, expected to enhance revenue opportunities [15][21] Market Data and Key Metrics Changes - Total covered lives increased from approximately 4 million a year ago to about 51 million today, indicating a substantial expansion in market access [11] - The company is focused on achieving blanket insurance coverage and the implementation of a category one CPT code effective January 1, 2026, which is critical for scaling operations [10][14] Company Strategy and Development Direction - The company aims to achieve cash flow breakeven and profitability by focusing on insurance policy coverage and the category one CPT code [20][24] - The strategy includes leveraging strong published data to drive insurance expansion, leading to sustainable revenues and margins [8][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued revenue growth due to the expected publication of guidelines and the implementation of the CPT code [32][34] - The company anticipates that as insurance coverage increases, the percentage of sales through full-price purchase orders will also rise, enhancing revenue potential [19][20] Other Important Information - The company is currently managing a legal settlement from 2019, which will be paid in installments starting January 2026, allowing the company to move forward without the burden of ongoing litigation [42][45] - The company has made strides in expanding its insurance coverage, which is expected to positively impact sales volume in the coming quarters [26] Q&A Session Summary Question: When do you expect the guidelines to be published? - Guidelines are expected to be published by the end of the month, which will lead to increased orders based on policy coverage [32][33] Question: How do you see your operating expenses in the near and medium term? - Operating expenses are expected to increase as investments in sales and marketing are necessary to meet upcoming demand, but as a percentage of sales, they are expected to decrease [35][37] Question: Can you provide more details on the RED technology? - The response to the RED technology has been stronger than expected, and the company is optimistic about its commercial execution despite the slow uptake in revenue [38][40] Question: Can you provide details on the legal settlement? - The legal settlement amounts to $750,000, to be paid in equal monthly installments starting January 2026, which the company views as a positive step to eliminate legal risks [42][45]

Media: Troy Kirkpatrick VP, Public Relations 858.617.2361 [email protected] Investors: Adam Reiffe Sr. Director, Investor Relations 201.847.6927 [email protected] SOURCE BD (Becton, Dickinson and Company) BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions t ...

Group 1: Event Overview - The 27th China Beijing International Science and Technology Industry Expo concluded with over 600 new technology products launched and 43 projects signed, totaling over 5.8 billion yuan [1] - The exhibition area increased by 50% compared to the previous year, covering 50,000 square meters with over 800 domestic and international companies showcasing more than 1,200 cutting-edge technologies and innovations [1] Group 2: Technological Innovations - Notable exhibits included the Zhuque II and III rockets, the Chang Zheng 8甲 rocket, and the "Cloud Walker" supersonic aircraft model, which is expected to complete its first flight by 2026 [4] - The ROPA orthopedic surgical robot, which enhances precision and efficiency in surgeries, was highlighted as a significant advancement in medical technology [4][8] - The AI digital road station and the MogoMind AI model were showcased for their capabilities in real-time traffic data integration and decision-making, applicable in smart city and autonomous driving scenarios [5] Group 3: Robotics and Automation - The event featured various robots, including the N2 robot, which gained popularity among children for its engaging design and capabilities [2][3] - The Tian Gong 2.0 humanoid robot demonstrated advanced walking capabilities and was part of a broader trend towards integrating robotics in manufacturing and logistics [3] Group 4: Impact on Daily Life - Innovations such as AI-powered smart pillows, anti-fraud digital assistants, and AI waste incineration technology were presented as solutions to enhance quality of life and environmental sustainability [7] - The AI waste incineration technology aims to stabilize pollutant emissions by dynamically adjusting operational parameters based on real-time monitoring [7] Group 5: International Collaboration - The concurrent Beijing International Investment Trade Fair facilitated opportunities for international cooperation, particularly in high-tech sectors like robotics and semiconductor manufacturing [10] - Saudi Arabian entities engaged in discussions with Chinese companies to explore partnerships in advanced manufacturing and green energy [10]

Financial Data and Key Metrics Changes - Total revenue for the first quarter was $26.2 million, down 10% compared to the same period in 2024, primarily due to pricing pressure in the OEM channel [9][20] - Gross margin for the first quarter was 56%, down nine percentage points year over year, driven by a $4 million drop in MONOVISC and ORTHOVISC sales [22][23] - Operating expenses decreased by 12% year over year to $19 million, reflecting cost-saving measures [26] Business Line Data and Key Metrics Changes - Revenue in the commercial channel increased by 18% year over year to $11.3 million, with international OA pain products growing by 13% [20] - The regenerative solutions portfolio achieved 33% growth year over year, driven by the performance of the Integrity product [12][20] - OEM channel revenue decreased by 23% to $14.9 million, primarily due to lower pricing for MONOVISC and ORTHOVISC [21] Market Data and Key Metrics Changes - The company experienced ongoing pricing challenges in the domestic OA pain market, impacting overall revenue [6][9] - International OA pain management growth was reported at 13% year over year, indicating strong performance in global markets [9][20] Company Strategy and Development Direction - The company is focusing on leveraging proprietary hyaluronic acid technologies and has made progress in strategic initiatives [7][8] - Plans to diversify revenue sources and grow the OEM channel outside of existing partnerships are underway, particularly through new product expansion programs [11] - The anticipated U.S. approvals of HYALOFAST and CINGAL are seen as key drivers for future growth in tendon and cartilage repair markets [8][18] Management's Comments on Operating Environment and Future Outlook - Management acknowledged ongoing pricing pressures but expressed confidence in the company's ability to return to historic production levels in the second half of the year [35] - The company expects modest pricing rebounds in the second quarter and anticipates accelerated growth in the second half of the year [29][30] - Management remains optimistic about the long-term trajectory, driven by investments in regenerative solutions and upcoming product launches [33] Other Important Information - The company ended the first quarter with $53 million in cash and no debt, indicating a strong liquidity position [27][71] - Adjusted EBITDA guidance for 2025 has been updated to a range of negative 3% to positive 3%, reflecting lower pricing and manufacturing challenges [30][31] Q&A Session Summary Question: Timeline and investment for the CINGAL bioequivalence study - Management expects to begin the study by the end of the year and will provide further updates as progress is made [38][39] Question: OEM guidance and expected improvement in revenue - Sequential growth in OEM revenue is anticipated to be driven primarily by pricing adjustments [41] Question: Commercial revenue guidance maintenance - The decision to maintain guidance was based on strong Q1 performance and expected challenges in Q2 [43] Question: Timing for HYALOFAST final module filing - The final module is expected to be filed by the end of the year, with updates to be provided in future earnings calls [48][49] Question: Distribution plans for CINGAL - Management is exploring distribution opportunities and will provide more details as they develop [68] Question: Cash flow expectations and regulatory process funding - The company has sufficient cash to navigate the regulatory processes for both HYALOFAST and CINGAL [71][72]