Financial Data and Key Metrics Changes - For Q1 2025, total revenue was $8 million, with $7.8 million from U.S. net product revenue for Nefi and $200,000 from collaboration revenue [19][20] - The company reported a net loss of $33.9 million or $0.35 per share for the first quarter [23] - Cash, cash equivalents, and short-term investments stood at $275.7 million as of March 31, 2025, indicating a runway of at least three years [24] Business Line Data and Key Metrics Changes - Nefi generated $7.8 million in U.S. net product revenue in Q1 2025, reflecting strong demand among healthcare providers and patients [5][19] - The company has expanded commercial insurance coverage from 27% to 57% during the year, with ongoing discussions for further coverage [6][14] Market Data and Key Metrics Changes - The U.S. market potential for Nefi is estimated at $3 billion, with 6.5 million patients prescribed epinephrine and an additional 13.5 million diagnosed patients without prescriptions [5] - The company aims to achieve 80% commercial lives coverage by Q3 2025, with current coverage at 57% without prior authorization [45][68] Company Strategy and Development Direction - The company is focused on deepening physician engagement, expanding access, and establishing a global commercial footprint for Nefi [11] - A comprehensive direct-to-consumer campaign titled "Hello Nefi, Goodbye Needles" is set to launch, aimed at raising awareness and driving adoption [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum of Nefi, citing strong early revenue and positive physician testimonials [25] - The company anticipates an inflection point in sales during Q3 2025, particularly with the launch of the one-milligram dose and the DTC campaign [62] Other Important Information - The company plans to invest $40 million to $50 million in the DTC campaign for the remainder of 2025, with expected benefits starting in Q3 [21][22] - The co-promotion agreement with ALK will allow the company to retain full control over U.S. commercialization while benefiting from ALK's sales force [20] Q&A Session Summary Question: How much of the Q1 sales figure is attributed to inventory? - Management indicated that Q1 numbers were minimally influenced by inventory, with steady inventories at that point [28][29] Question: What would the gross to net discount look like in Q1? - The gross to net discount was around 60% for Q1, expected to decrease to closer to 50% as payer coverage improves [30][31] Question: Can you confirm that there are no prior auth requirements for access to Nefi for 57% of commercial lives? - Management confirmed that 57% have coverage without prior authorization, while about 90% have coverage when including those requiring prior authorization [35][36] Question: What is the strength of the Nefi experience program? - The Nefi experience program has enrolled over 2,500 physicians, with positive feedback and high prescription rates among participants [41][42] Question: How is the company tracking towards the goal of 80% commercial lives by Q3? - Management noted ongoing negotiations with several payers, with a high approval rate for prior authorizations, indicating positive progress towards the goal [44][46] Question: What is the current market share and where does the company hope to be by the end of the year? - The company currently holds about 1.3% market share overall, with higher shares among targeted physicians, and expects to see growth with upcoming catalysts [70][72]

Waldencast (WALD) Q1 2025 Earnings Call May 14, 2025 08:30 AM ET Speaker0 Good day, and welcome to the Waldencast First Quarter twenty twenty five Earnings Call. All participants will be in listen only mode. A question and answer session will follow the formal presentation. Please note that this event is being recorded. I will now hand you over to Alison Malkin, Partner ICR. You may proceed. Speaker1 Thank you and welcome to the Weldon Cast plc first quarter fiscal twenty twenty five earnings call. Here wit ...

Kornit Digital (KRNT) Q1 2025 Earnings Call May 14, 2025 08:30 AM ET Speaker0 Greetings, and welcome to Kornit Digital's First Quarter twenty twenty five Earnings Conference Call. As a reminder, this call is being recorded. I would now like to turn the conference over to our host, Mr. Jared Maeman, Investor Relations for Kornit Digital. Mr. Maeman, you may begin. Speaker1 Thank you, operator. Good day, everyone, and welcome to Kornit Digital's first quarter twenty twenty five earnings conference call. Joini ...

Similarweb (SMWB) Q1 2025 Earnings Call May 14, 2025 08:30 AM ET Speaker0 Greetings and welcome to the SimilarWeb Q1 Fiscal twenty twenty five Earnings Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Rami Myerson, Vice President, Investor Relations. Thank you. You may begin. Speaker1 Thank you, operator. Welcome everyone to our fir ...

Financial Data and Key Metrics Changes - Revenue for the second fiscal quarter decreased by 1% to $18 million compared to $18.1 million for the prior year period [13] - For the six months ended March 31, 2025, revenue decreased by 9% to $34.9 million compared to $32.1 million for the prior year period [13] - The company reported a net loss attributable to common shareholders of $111.4 million for the three months ended March 31, 2025, compared to a loss of $15.8 million for the same period in the prior year [17] - EBITDA for the three months ended March 31, 2025, was a loss of $14.7 million compared to a loss of $16.5 million for the same period in the prior year [17] - Adjusted EBITDA for the three months ended March 31, 2025, was a gain of $12.7 million compared to a loss of $16.5 million for the same period in the prior year [17] Business Line Data and Key Metrics Changes - Alico harvested approximately 4.7 million and 8.7 million pound solids of fruit for the three and six months ended March 31, 2025, respectively, compared to 5.8 million and 10.4 million pound solids in the same periods of the prior fiscal year [14] - Land management and other operations revenue increased by 10,774% for the three and six months ended March 31, 2025, primarily due to increased rock and sand royalty income and sod sales [15] Market Data and Key Metrics Changes - The company completed the sale of 2,100 acres of land in the second quarter of 2025, contributing to other income of $15.3 million for that quarter [16] - The company raised its outlook for land sales to potentially exceed $50 million for the fiscal year, a 150% increase from prior guidance [6] Company Strategy and Development Direction - The company is transitioning to a diversified land company, having completed its major capital investment in citrus operations [5] - Alico is actively engaged with agricultural operators to diversify its remaining agricultural activities, including sod production and seasonal crop leases [7] - The company is pursuing development opportunities for its properties, including the Corkscrew Grove Villages project, which aims to create mixed-use master plan communities [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic transformation, projecting a cash balance of approximately $25 million and net debt of about $60 million by the end of the fiscal year [19] - The company expects to generate approximately $20 million in adjusted EBITDA for fiscal year 2025, supported by land sales and cash generated from citrus harvests [20] Other Important Information - The company amended its credit agreement to adjust financial covenants and reduce insurance coverage requirements, resulting in cost savings [12] - A $50 million share repurchase program was announced as part of the capital allocation strategy [12] Q&A Session Summary Question: Can you provide additional details on the $15.8 million from land sales in the quarter? - The $15.8 million was from the sale of 2,100 acres located in Henry County [25][26] Question: Are there ongoing discussions for additional land sales to achieve the $50 million target? - The company is in discussions for additional land sales, but the timing is uncertain due to the diligence process [28] Question: What milestones can be expected for the Corkscrew project before potential entitlement approvals? - The entitlement approvals themselves will serve as milestones, with individual meetings and revisions expected throughout the process [29]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $23 million, including net product revenues of $17.4 million, consistent with Q1 2024 and an increase from $16.4 million in Q4 2024 [5][17] - Net loss for Q1 2025 was $38.6 million, an improvement from a net loss of $46.6 million in Q1 2024, attributed to higher license revenues and lower expenses [18] - Cash and cash equivalents as of March 31, 2025, were $194.7 million, down from $250.9 million at December 31, 2024, primarily due to net loss from operations [18] Business Line Data and Key Metrics Changes - The company reported $5.6 million in milestone and royalty payments included in total revenue for the quarter [6] - The LOTUS-seven study showed an overall response rate of 95.5% and a complete response rate of 90.9% in 22 efficacy evaluable patients [14] Market Data and Key Metrics Changes - The company is focusing on maintaining its position as a treatment option for third-line plus DLBCL patients, with promising data from the LOTUS-seven study [5][10] - The competitive landscape is highlighted by the potential of ZYNLATA plus glufitamab to be a best-in-class combination in a highly competitive market [6][11] Company Strategy and Development Direction - The company aims to expand the use of ZYNLATA into earlier lines of therapy in DLBCL and indolent lymphomas, believing in the potential for significant revenue growth [10][22] - The strategy includes pursuing regulatory discussions and compendia strategies based on the data from ongoing trials [8][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming catalysts and the company's cash runway expected to fund operations into the second half of 2026 [10][21] - The management is optimistic about the promising data from ongoing trials and the potential to change treatment paradigms for patients with aggressive lymphoma [15][22] Other Important Information - The LOTUS-five trial is on track to reach the pre-specified number of progression-free survival events by the end of 2025, with top-line data expected thereafter [8][20] - The company is engaged in discussions for potential research collaborations to advance its programs [9][20] Q&A Session Summary Question: Follow-up time for patients and CR conversion times - Management indicated that follow-up assessments are ongoing, with high complete response rates being a strong biomarker for durability [27][28] Question: Competitive strategy and regulatory engagement - The company plans to engage with regulatory authorities once sufficient data from approximately 100 patients is available [30] Question: Expected patient numbers at upcoming conferences - Management confirmed that more patients than the 22 already discussed will be presented at the EHA and ICML conferences, but exact numbers cannot be disclosed [34] Question: Timing for LOTUS-five data readout - The company expects to reach the pre-specified number of PFS events this year, with data readout potentially at the end of this year or early next year [42] Question: Discontinuation of the ADCT-602 program - The discontinuation of the ADCT-602 program has minimal capital implications, allowing focus on advancing other research programs [50][51]

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]

Financial Data and Key Metrics Changes - Net sales for Q1 2025 increased by 4.5% to $10 million compared to $9.6 million in the same quarter last year, driven by higher volumes with recurring national customers [18] - Profit for Q1 2025 remained flat at $3.4 million compared to the previous year [19] - Gross margin decreased to 33.9% from 35.6% year-over-year, primarily due to higher cost of goods sold [19] - Operating loss for Q1 2025 was $1.7 million, compared to a loss of $700,000 in Q1 2024 [20] - Cash used in operating activities increased to $5.4 million from $2.4 million year-over-year, driven by higher inventory purchases [21] Business Line Data and Key Metrics Changes - The company launched a new multifunctional soda line, which includes flavors like berry bubbly and strawberry vanilla, and secured national distribution in Sprouts Farmers Market [8][9] - Expanded presence at Albertsons Safeway for Reed's Ginger Ale, adding over 1,100 new points of distribution [10] - Successfully launched a national offshoot program with Flying Cauldron at Albertsons, exceeding internal projections [10] Market Data and Key Metrics Changes - Distribution gains were noted in three states at Trader Joe's for classic new alcohol products, reflecting growing demand across core functional and alcohol portfolios [12] - The company executed national display programs across core product lines at Sprouts Farmers Market, strengthening visibility [11] Company Strategy and Development Direction - The company is focused on sustainable growth and profitability, with a commitment to delivering premium, better-for-you beverages [15] - A strategic initiative includes transitioning from glass bottles to cans, enhancing cost structure and scalability [13] - The company is taking a measured approach to innovation, prioritizing its heritage and brand credibility [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about operational improvements and the alignment across the team, laying groundwork for profitable growth [22] - The company expects some modest gross margin pressure in Q2 due to seasonal promotion activity and higher trade spend [14] - Management is focused on improving cash flow performance in the second half of 2025 [26] Other Important Information - The company appointed Rude Baker to the board of directors, bringing extensive experience in the beverage industry [7] - The company is actively evaluating alternative suppliers and sourcing strategies to mitigate potential disruptions from global trade dynamics [13] Q&A Session Summary Question: Operating expenses were higher than expected; what should be expected going forward? - The increase in SG&A is attributed to upfront investments in personnel and marketing to support strategic initiatives [26] Question: Will gross margins be pressured in Q2? - There may be seasonal compression in gross margins due to trade discounts and additional investment in the functional beverage launch [28] Question: Is there any revenue guidance for the year? - The company has not provided specific revenue guidance but is focused on growth and operating efficiency [33]

Smith Douglas Homes (SDHC) Q1 2025 Earnings Call May 14, 2025 08:30 AM ET Speaker0 Thank you for standing by. My name is Tina, and I will be your conference operator today. At this time, I would like to welcome everyone to the Smith Douglas Homes First Quarter twenty twenty five Earnings Call and Webcast. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. Thank you. I would now like to turn the call over to Joe Thomas ...

Scholar Rock Holding (SRRK) Q1 2025 Earnings Call May 14, 2025 08:15 AM ET Company Participants Rushmie Nofsinger - Vice President of Corporate Affairs & Investor RelationsDavid Hallal - CEO & ChairmanAkshay Vaishnaw - President, R&DKeith Woods - COOVikas Sinha - CFOMichael Yee - Managing DirectorDavid Nierengarten - Managing Director - Equity ResearchGary Nachman - Managing Director - Equity ResearchMalcolm Hoffman - Senior BioPharma Equity Research AssociateAndres Maldonado - Vice President Conference Cal ...