The fancier the slides, the weaker the product.Spend time on the latter.Over generalization, but everything I need to see (as an investor) can be expressed in text bullet points and bar charts. ...

Incyte (INCY) Q2 2025 Earnings Call July 29, 2025 08:00 AM ET Company ParticipantsGreg Shertzer - Senior Director - IRBill Meury - CEO, President & DirectorChristiana Stamoulis - EVP & CFOPablo Cagnoni - President and Head of Research & DevelopmentSalveen Richter - Biotechnology Equity ResearchMohamed Issa - EVP & Head - U.S. OncologyBrian Abrahams - MD & Co-Head of Biotechnology ResearchMatteo Trotta - EVP & GM - U.S. DermatologyConor MacKay - Equity Research Senior AssociateKripa Devarakonda - VP - Biotec ...

Core Product Development Principle - Shipping something to someone always wins, emphasizing rapid iteration and feedback loops over big launches [1][34] - The key is enabling rapid iterative loops to get feedback from real users and maximize shots at the goal [1] - In the age of AI, this translates to building a "skateboard" first, then evolving it to a "car," ensuring a continuously viable product [2][4] - A continuously viable solution is significantly more valuable because it provides feedback along the way, avoiding building in a vacuum [5][6] Feedback Loop Implementation - Establish a feedback loop with real users who can see something, provide feedback, and allow for iterative improvements, ideally within a day [7] - Being able to ship every day is crucial for a fast feedback loop, requiring specific focus on the target customers [9] - Work with real people (not just personas) to understand their problems and build empathy [10][11] - Write the PI (Product Information) FAQ or launch blog post early to sanity check and communicate the product effectively [12] Navigating Constraints and AI Integration - Design the best product first, before considering constraints like legal, compliance, and financial aspects [15] - AI accelerates all aspects of product building, but the fundamental process of talking to users and getting feedback remains the same [26] - Product management becomes more critical as the cost of writing code approaches zero, emphasizing customer knowledge and rapid feedback [28][29]

Company Overview - Nilörn Group is a global company established in the 1970s, specializing in adding value to brands through branding and design, particularly in labels, packaging, and accessories for the fashion and clothing industry [1] - The company provides comprehensive, creative, and customized solutions in branding, design, product development, and logistics [1] - Nilörn Group operates through its own subsidiaries in multiple countries, including Sweden, Denmark, the UK, Germany, Belgium, Portugal, Hong Kong, India, Turkey, China, Bangladesh, Italy, Switzerland, Vietnam, the USA, and Pakistan [1] Upcoming Presentation - A presentation will be held via Teams on July 16 at 08:30 am CET, where the CEO will present the report [2] - Participants can register for the presentation through a provided link [2]

User Acquisition - The primary challenge is acquiring users [1] - Success hinges on creating a desirable product and effectively promoting it [1] Product Development - The real difficulty lies in creating a product that people desire [1] Funding - Securing funding is challenging without a product that attracts users [1]

Technology Evolution - Technology potential is increasing significantly with the evolution of computing [1] - Products need to evolve rapidly because yesterday's solutions may not be useful today, emphasizing the need for adaptation and speed [2] - Optimizing for speed is crucial, rather than striving for a perfect but static product [2] Challenges of Speed and Scale - Evolving products rapidly becomes challenging when hundreds or thousands are already deployed [3] - Managing training, production at scale, and continuous evolution simultaneously is a key problem [4]

Competitive Landscape - Startups face existential threats and must ship products quickly to survive [1] - Larger companies like Amazon may not face the same immediate pressure to deliver high-quality products, as employees' jobs may be more secure [1] - The company believes that if it had shipped a product of similar quality to some hyperscalers, it would have been out of the market a year ago [1] Product Development - Startups need to ship products fast to survive [1] - The quality of the product is critical for the company's survival in the market [1]

Merger Negotiations - Eyenovia is in ongoing negotiations for a binding merger agreement with Betaliq, a clinical-stage pharmaceutical company focused on glaucoma [2] - The exclusivity period for the merger discussions has been extended until June 7, 2025, to facilitate the completion of the agreement [2] Optejet Development - The development of the Optejet user-filled device (UFD) is progressing well, with plans to file for U.S. regulatory approval in September 2025 [3] - Approval of the Optejet could lead to multiple commercial opportunities, both directly with consumers and through partnerships with eye care practitioners and license partners [3] Financial Performance - For Q1 2025, Eyenovia reported a net loss of $3.5 million, or $1.59 per share, a significant improvement from a net loss of $10.9 million, or $18.75 per share, in Q1 2024 [6][16] - Research and development expenses decreased by 85% to $0.7 million in Q1 2025, compared to $4.4 million in Q1 2024 [6] - General and administrative expenses were reduced by 35% to $2.4 million in Q1 2025, down from $3.6 million in Q1 2024 [7] - Total operating expenses for Q1 2025 were $3.0 million, a decrease of 70% from $10.1 million in Q1 2024 [7] Cash Position - As of March 31, 2025, the company's unrestricted cash and cash equivalents were $3.9 million, an increase from $2.1 million at the end of 2024 [7][14] - A debt restructuring agreement was entered into earlier this year, deferring certain repayment obligations until October 2025, which has contributed to extending the company's cash runway [4][5]

Financial Data and Key Metrics Changes - The company reported adjusted EBITDA of $30 million for Q1 2025, at the high end of guidance, driven by strong operational performance and increased production and sales volumes, primarily due to the Augusta acquisition [6][24] - Net sales increased by 46% to $378 million compared to Q1 2024, largely attributed to the Augusta acquisition [6][24] - The company incurred a consolidated net loss of approximately $6 million from continuing operations, equating to $0.36 per diluted share [23] Business Line Data and Key Metrics Changes - The Augusta mill integration is progressing well, with targeted volume and cost synergies expected by the end of 2026 [7] - Fixed cost structure was reduced by eliminating over 200 positions, representing around 10% of total roles, aiming for $30 to $40 million in savings for 2025 [7][18] Market Data and Key Metrics Changes - Industry shipments increased by 2% in Q1 2025 compared to Q1 2024, with demand projected to grow by 3% to 5% in 2025 [8][9] - Industry utilization rates improved to 88% in Q1 2025 from 84% in Q1 2024, but remain below the cross-cycle average of 90% to 95% [10] Company Strategy and Development Direction - The company aims to strengthen its position as a premier independent supplier of paperboard packaging products, focusing on product development in compostable food service products, lightweight folding cartons, and alternative poly-free barrier technologies [13][14][15] - The company is exploring expansion into additional paperboard substrates, which make up approximately 50% of the paperboard market outside of SBS [15][17] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about medium to long-term industry prospects, expecting strong margins and cash flows through the cycle [34] - The company anticipates continued demand recovery, with internal utilization projected at around 85% and revenue expectations of approximately $1.5 to $1.6 billion for 2025 [29] Other Important Information - The company repurchased approximately $11 million of its shares in Q1 2025, totaling about $15 million since the new $100 million share buyback authorization [7][26] - The company is targeting a reduction in SG&A as a percentage of sales to 6% to 7% by year-end 2025 [25] Q&A Session Summary Question: What is the current status of FPB imports and exposure to tariffs? - Management noted that imports were up in 2024, with forecasts indicating a 5% decrease in imports and a 1% increase in exports for 2025 [38] Question: What are the criteria for evaluating M&A opportunities for expanding product offerings? - The company emphasized the need for strategic fit, quality assets, and a belief in the ability to win in the market [46] Question: What is the expected impact of cost savings in Q2 and the status of synergies from Augusta? - Management expects to see roughly double the amount of savings in Q2 compared to Q1, with a significant portion of the $40 million to $50 million in synergies from Augusta being volume synergies [50][51]

Financial Data and Key Metrics Changes - In Q4 2024, YUPELRI net sales increased by 10% year-over-year, reaching $66.7 million, marking an all-time high [4] - Full year YUPELRI sales totaled $239 million, with an 8% increase in net sales for 2024 and an 11% growth in demand [11][14] - Collaboration revenue grew by 8% to approximately $19 million in Q4 [32] - Operating expenses, excluding share-based compensation, increased to $22 million due to higher commercial and medical affairs spending [32] Business Line Data and Key Metrics Changes - YUPELRI's hospital performance saw doses increase by 49% year-over-year, with 285,000 redoses pulled through to hospital customers [4][13] - The hospital business accounts for roughly 10% of total YUPELRI volume, with 90% coming from community settings [77] - Ample enrollment in the CYPRESS study for ampreloxetine is on track, with expectations for expedited NDA filing [5][20] Market Data and Key Metrics Changes - TRELEGY reported full year sales of $3.5 billion, up 26% year-over-year, triggering a $50 million milestone payment [15] - The company anticipates achieving an additional $150 million in milestones from TRELEGY in 2025 and 2026 [16] Company Strategy and Development Direction - The company aims to grow YUPELRI revenue while increasing brand profitability, with potential near-term sales milestones in the U.S. and royalties from China [7] - For ampreloxetine, the focus is on completing enrollment in the CYPRESS study and preparing for an expedited NDA filing [8] - The company is committed to maximizing the value of TRELEGY and returning excess capital to shareholders [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the financial position entering 2025, with $88 million in cash and no debt [39] - The company is focused on driving YUPELRI growth through strong demand generation and a patient-centered strategy [40] - Management highlighted the potential impact of ampreloxetine on patients with MSA suffering from nOH symptoms [41] Other Important Information - The company completed market research indicating a significant unmet need for better nOH therapies, with over 70% of surveyed neurologists agreeing [25] - The target product profile for ampreloxetine aligns with physician preferences, suggesting a favorable outlook if approved [28] Q&A Session Summary Question: What drove the success in the hospital channel this quarter? - The success was attributed to effective execution of strategy and wins in larger systems, with therapeutic interchange contributing to increased volume [45][46] Question: What is the trend for the hospital performance into 2025? - Q1 is typically softer, but there is a demonstrated need for YUPELRI, which may provide a tailwind [60] Question: What are the next steps for YUPELRI in China? - The company is waiting for regulatory feedback from Viatris, with a typical two-year window expected from submission to approval [62] Question: What was the nature of the recent FDA feedback on ampreloxetine? - The feedback was from a Type C meeting to clarify filing content and ensure alignment on key requirements for full approval [67] Question: What percentage of YUPELRI sales are non-hospital sales? - The hospital business accounts for roughly 10% of total YUPELRI volume, with the community setting making up the majority [77] Question: What is the bar for success for the CYPRESS readout? - A one-point change in the OHSA composite score is considered clinically meaningful for success [88]