Key Takeaways J&J's Innovative Medicine unit is expected to post Q1 growth despite Stelara LOE impactJNJ's growth likely driven by Darzalex, Tremfya, Erleada and the uptake of newer therapies like CarvyktiJNJ faces pressure from Stelara biosimilars, Imbruvica decline and Part D redesign headwindsJohnson & Johnson (JNJ) , via its Innovative Medicine segment, markets a broad portfolio of blockbuster therapies across key areas including neuroscience, cardiovascular and metabolic diseases, immunology, oncology, ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $75.5 million, with product revenue net at $59.9 million, an increase from $51.9 million in Q3 2025 and $54.4 million in Q4 2024 [5][20] - Royalty revenue was $15.6 million in Q4 2025, compared to $2.6 million in Q3 2025 and $4.7 million in Q4 2024 [6][30] - Net income based on GAAP for Q4 2025 was $13.4 million, or $0.20 per basic share, compared to $8.8 million in Q3 2025 [26][27] Business Line Data and Key Metrics Changes - NERLYNX sales included U.S. net sales of $55.2 million in Q4 2025, up from $51.8 million in Q3 2025 [29] - Total prescriptions for NERLYNX increased by approximately 1.4% quarter-over-quarter, while new prescriptions decreased by about 11.4% [6][22] - NERLYNX ex-factory bottle sales were 3,298 in Q4 2025, representing a 12% increase quarter-over-quarter [21] Market Data and Key Metrics Changes - The distribution model showed that 63% of business was through the specialty pharmacy (SP) channel and 37% through the specialty distributor (SD) channel [19] - Demand in the SD channel grew by about 17% quarter-over-quarter and 46% year-over-year [23] Company Strategy and Development Direction - The company is focused on increasing awareness of NERLYNX's dual indication in HER2-positive breast cancer and enhancing clinical education [16][17] - Puma is evaluating several drugs for potential in-licensing or acquisition to diversify its portfolio [15] Management's Comments on Operating Environment and Future Outlook - Management expressed commitment to maintaining positive net income and financial discipline, guiding for continued profitability in 2026 [37] - The company anticipates net NERLYNX product revenue for fiscal year 2026 to be in the range of $194 million to $198 million [31] Other Important Information - The company reported cash earned of approximately $3.1 million in Q4 2025, with total outstanding principal debt decreasing to approximately $22 million [35] - The company plans to submit a protocol amendment to the FDA to increase the dose of alisertib in ongoing trials [13] Q&A Session Summary Question: Can you speak to the dynamics around the inventory build this fourth quarter? - Management noted that inventory builds are typical at the end of the year, driven by expectations of price increases [41] - It was mentioned that inventory usually burns off in the first quarter following the fourth quarter build [42]

Protagonist Therapeutics FY Conference Summary Company Overview - **Company**: Protagonist Therapeutics (NasdaqGM:PTGX) - **Event**: FY Conference at the 44th J.P. Morgan Healthcare Conference - **Date**: January 13, 2026 Key Points Industry and Market Context - Protagonist is positioned in the biopharmaceutical industry, focusing on innovative therapies for unmet medical needs, particularly in the areas of immunology and rare diseases [2][26] Core Assets and Development Pipeline - **Icotrokinra (Ico)**: - Partnered with Johnson & Johnson (J&J) - Aims to set a new standard of care in psoriasis and other IL-23-mediated indications - First and only oral IL-23 pathway blocker in late-stage development - Potential market opportunity exceeding $80 billion across four indications: psoriasis, psoriatic arthritis, ulcerative colitis (UC), and Crohn's disease [4][5][6] - Anticipated peak sales of over $10 billion [6] - **Rusfertide**: - Partnered with Takeda - A synthetic peptide mimetic of hepcidin, targeting polycythemia vera (PV) - Phase 3 VERIFY study results deemed practice-changing, with potential peak revenue of $1-$2 billion [10][11] - Fast-track status and breakthrough therapy designation expected to expedite approval [12] - **Emerging Assets**: - **PN-881**: An oral IL-17 antagonist, expected to enter Phase I studies [13][15] - **PN-8047**: An oral hepcidin functional mimetic, complementing Rusfertide, with Phase I initiation expected by year-end [16][17] - **PN-477**: A novel oral triple agonist for obesity, with IND-enabling studies ongoing [18][19] - **PN-458**: A new dual GLP-1/GIP agonist for obesity, enhancing the obesity portfolio [20] Financial Position - Protagonist ended Q3 2025 with approximately $679 million in cash, sufficient to fund operations through 2028 [21][22] - Revenue potential from partnered assets: - Icotide: Eligible for $600 million in future milestones and 6%-10% royalty range, averaging around 7.25% [22][23] - Rusfertide: Potential opt-out fee of $400 million, with royalties ranging from 14%-29% based on sales [24][25] Strategic Vision - Protagonist aims to maximize shareholder value while expanding its discovery pipeline, with aspirations to grow its market cap from $5 billion to $10-$20 billion [33] - The company emphasizes the importance of partnerships with pharmaceutical companies for scaling and expertise, particularly in the obesity space [34][46] Upcoming Catalysts - Anticipated commercial launches for Icotide and Rusfertide within the year [26] - Completion of pivotal studies and initiation of Phase II studies for emerging assets [26] Additional Insights - The company is focused on maintaining a balance between funding internal R&D and returning capital to shareholders through potential stock buybacks and dividends [34][35] - Protagonist is committed to expanding its pipeline with a focus on high-priority targets in immunology, including IL-4 [53] Conclusion Protagonist Therapeutics is at a pivotal growth stage, with a robust pipeline of innovative therapies and a strong financial position, poised for significant market impact in the coming years. The strategic partnerships and upcoming product launches are expected to drive value creation and enhance shareholder returns.

The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this Application Proof, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Application Proof. Application Proof of Genuine Biotech Limited 真實生物科技有限公司 (the "Company") (Incorporated in the Cayman Islands with limited liability) WARN ...

Core Insights - Xenon Pharmaceuticals Inc. has appointed Tucker Kelly as Chief Financial Officer, bringing extensive strategic and commercial finance expertise to the company as it prepares for the commercialization of its lead candidate, azetukalner [1][2] Company Overview - Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of therapeutics for patients in need [4] - The company is advancing azetukalner, a selective Kv7 potassium channel opener, currently in Phase 3 clinical trials for epilepsy, major depressive disorder, and bipolar depression [5] Leadership Appointment - Tucker Kelly has over 25 years of experience in corporate and financial strategy for life sciences companies, previously serving as Executive Vice President, CFO, and Treasurer at Deciphera Pharmaceuticals [2] - His role at Deciphera included overseeing the company's growth and strategic financial planning, culminating in a $2.4 billion acquisition by Ono Pharmaceuticals in 2024 [2] Compensation Details - In connection with his appointment, Mr. Kelly was granted an option to purchase 225,000 common shares at an exercise price of $41.90, with shares vesting over four years [3] - Additionally, he received 30,000 restricted share units (RSUs) that will vest over four years, subject to his continued service with the company [3]

Financial Data and Key Metrics Changes - Total revenues for Q2 2025 were $102.6 million, a 5% increase compared to $97.9 million for the same period in 2024, primarily driven by growth in Fanapt revenue due to the bipolar commercial launch [15][16] - Net loss for the first six months of 2025 was $56.7 million, compared to a net loss of $8.7 million for the same period in 2024, with operating expenses increasing to $182.2 million from $117.3 million [20][27] - Cash and cash equivalents as of June 30, 2025, were $325.6 million, a decrease of $49.1 million compared to December 31, 2024 [21] Business Line Data and Key Metrics Changes - Fanapt net product sales for the first six months of 2025 were $52.8 million, a 21% increase compared to $43.7 million in the same period in 2024, attributed to increased volume [16][22] - HETLIOZ net product sales were $37.1 million for the first six months of 2025, a 4% decrease compared to $38.8 million in the same period in 2024, due to a decrease in volume [16][19] - POMVORY net product sales were $12.7 million for the first six months of 2025, an 18% decrease compared to $15.4 million in the same period in 2024, attributed to a decrease in volume and price [19] Market Data and Key Metrics Changes - Fanapt revenue increased by 27% compared to the same period in the prior year, driven by the launch of the bipolar I indication, with total prescriptions increasing by approximately 24% compared to 2024 [7][22] - HETLIOZ continues to retain the majority of market share despite generic competition for over two and a half years [17] - POMVORY new patient prescriptions grew to a record high since the initiation of Vanda's commercial launch [30] Company Strategy and Development Direction - The company is focused on expanding its sales force and increasing prescriber awareness for Fanapt and POMVORY, with plans to grow the sales force to approximately 50 representatives for POMVORY [29][30] - Vanda is preparing for the potential launch of Bisanti, with commercial product preparedness expected by the end of Q2 2026 [38] - The company aims to achieve total revenue from Fanapt, HETLIOZ, and POMVORY of between $210 million and $250 million by year-end 2025, indicating significant growth potential [33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing commercial efforts for Fanapt and POMVORY, noting significant growth indicators and a strong market response [28][29] - The company anticipates variability in HETLIOZ revenue due to continued generic competition and inventory stocking changes at specialty pharmacy customers [18][19] - Management highlighted the importance of ongoing investments in R&D and commercial strategies to facilitate future revenue growth [34] Other Important Information - The NDA for Bisanti for the acute treatment of bipolar I disorder was accepted for filing by the FDA, with a PDUFA target action date of February 21, 2026 [9][10] - The company is also pursuing regulatory updates for Tradipitant, with a target filing date for motion sickness set for December 30, 2025 [11][52] Q&A Session Summary Question: Outlook for Bisanti commercialization - Management expects to be ready for launch by the end of Q2 2026 if approved, with minimal additional commercial operation spend needed [38] Question: Nature of dispute related to POMVORY - The dispute relates to a gross to net item, with approximately $3 million recognized for the three months ended December 31, 2024, under dispute [42] Question: Progress on Tradipitant - Tradipitant for motion sickness is under review, with potential market entry as early as January 1, 2026, if approved [52] Question: Interactions with the FDA regarding Bisanti - Regulatory review is ongoing with no major issues reported, and the company is encouraged by the progress [58] Question: Margins and Medicaid impact for Bisanti - Medicaid typically accounts for 30% to 40% of unit volume, with significant rebates impacting net revenue calculations [60][62]