Core Insights - Johnson & Johnson (JNJ) has received FDA approval for the subcutaneous formulation of its EGFR/MET inhibitor, Rybrevant, now marketed as Rybrevant Faspro, which is approved for all indications of the intravenous version [1][8] Group 1: Product Approval and Advantages - Both Rybrevant and Rybrevant Faspro are approved in the U.S. for four indications related to EGFR-mutated non-small cell lung cancer (NSCLC), including two first-line and two second-line settings [2] - The subcutaneous formulation offers significant advantages in patient convenience, reducing administration time to about five minutes compared to several hours for the intravenous version [3][8] - The approval of Rybrevant Faspro is supported by data from the late-stage PALOMA-3 study, demonstrating its effectiveness compared to the IV formulation [5][8] Group 2: Competitive Landscape - With this approval, JNJ is better positioned to compete with AstraZeneca's Tagrisso, the current standard of care for EGFR-mutated NSCLC, although Tagrisso's oral administration remains a competitive advantage [4] Group 3: Oncology Sales and Growth Strategy - JNJ's oncology segment comprises approximately 27% of total revenues, with oncology sales rising nearly 21% year-over-year to $18.52 billion in the first nine months [10] - The company aims to achieve $50 billion in oncology sales by the end of the decade, having doubled its oncology sales from $10.7 billion in 2019 to $20.8 billion in 2024 [12] - JNJ is actively building its oncology pipeline through acquisitions, including a recent agreement to acquire Halda Therapeutics for $3.05 billion to enhance its prostate cancer portfolio [14]

Table of Contents As filed with the Securities and Exchange Commission on December 19, 2025 Registration No. 333-290598 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 KAZIA THERAPEUTICS LIMITED (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Australia 2834 Not applicable (I.R ...

Table of Contents As filed with the Securities and Exchange Commission on December 19, 2025 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 KAZIA THERAPEUTICS LIMITED (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 Australia 2834 Not applicable (Primary Standard Industrial Classification Code Number) Three International Towers Le ...

Core Insights - Johnson & Johnson (JNJ) received FDA approval for its precision therapy Akeega for a second indication in prostate cancer, specifically for BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC) [2][8] - The approval is based on the phase III AMPLITUDE study, which demonstrated a 54% reduction in the risk of radiographic progression or death with the Akeega-prednisone combination [3][8] - JNJ aims to achieve $50 billion in oncology sales by the end of the decade, with oncology currently accounting for approximately 27% of its total revenues [9][11] Drug Approval and Efficacy - Akeega combines the PARP inhibitor niraparib and the CYP17 inhibitor abiraterone acetate, marking the first FDA-approved precision medicine combination for BRCA2m mCSPC [3][5] - The drug's use has been expanded to an earlier stage of the disease, following its previous approval for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) in 2023 [4][8] Financial Performance and Growth Strategy - JNJ's oncology sales rose nearly 21% year over year in the first nine months to $18.52 billion, driven by strong market growth and key products [9] - The company has seen its stock rise 46% this year, outperforming the industry average growth of 16% [6] - JNJ is actively building its oncology pipeline through acquisitions, including a recent agreement to acquire Halda Therapeutics for $3.05 billion [13] Market Position and Future Outlook - The oncology segment's growth is supported by new drug launches, contributing significantly to revenue increases [10][12] - JNJ's ambitious target of $50 billion in oncology sales requires more than doubling its sales from 2024 levels, reflecting confidence in its marketed cancer drugs and pipeline [11][12]

Core Viewpoint - Revolution Medicines (RVMD) is a clinical-stage oncology company valued at $15 billion, focusing on targeted therapies for RAS-addicted cancers stemming from mutations in RAS proteins [1]. Group 1: Stock Performance - RVMD has gained 96.53% since the Trend Seeker "Buy" signal was issued on September 2 [2]. - The stock recently traded at $78.47, reaching an all-time high of $79.07 on December 3 [4][6]. - RVMD shares are up nearly 60% over the past year, with a 30.78% increase in the last month alone [6][7]. Group 2: Technical Indicators - Barchart gives RVMD a 100% technical "Buy" opinion, indicating strong momentum [6][7]. - The stock has a Weighted Alpha of +109.79 and a Relative Strength Index (RSI) of 80.28, suggesting strong upward momentum [7]. - A technical support level is identified around $75.12 [7]. Group 3: Financial Projections - Revenue for Revolution Medicines is projected to increase by 903.48% next year [7]. - Earnings are estimated to decrease by 12.15% next year [7]. Group 4: Analyst Sentiment - Wall Street analysts are overwhelmingly bullish on RVMD, although sentiment varies across other platforms [6].

Financial Data and Key Metrics Changes - Total revenue growth for the first nine months of the year was 21%, with recurring revenue growth of 26% [3][4] - The company is focused on maintaining financial discipline while achieving strong financial performance [4] Business Line Data and Key Metrics Changes - The late-stage programs, including Epkinly, RENA-S, and PETO, are expected to have meaningful registrational data and potential launches in 2027 [3][4] - Epkinly has been approved in third-line DLBCL and third-line follicular lymphoma, with ongoing efforts to expand into earlier lines of therapy [24][28] Market Data and Key Metrics Changes - The total addressable market for Epkinly in second-line follicular lymphoma is around 9,000 patients across major markets, contributing to a larger total addressable market of approximately 146,000 [27][28] - The company anticipates that PETO could exceed $1 billion in sales by 2029, indicating strong market potential [21] Company Strategy and Development Direction - The company has transitioned from a technology and out-licensing model to owning and developing its own assets, focusing on building capabilities in the U.S. and Japan [6][7] - The acquisition of Merus is part of a strategy to enhance capabilities in antibody development, particularly in oncology [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed high confidence in the clinical data for PETO, highlighting its breakthrough therapy designation and strong efficacy in combination therapies [12][13] - The company is optimistic about the upcoming clinical readouts and potential launches, particularly in 2026 and 2027 [21][42] Other Important Information - The company is committed to investing in its late-stage programs while managing leverage, aiming to be below three times gross leverage within 24 months of the Merus acquisition [52] - The focus remains on maximizing the potential of existing products while exploring new opportunities for growth [53] Q&A Session Summary Question: What is the strategy for continuing growth of own products? - The company aims to own at least 50% of new products entering the clinic and has been building out development and commercialization capabilities since 2019 [6][7] Question: What is the rationale behind the Merus acquisition? - The acquisition is intended to leverage existing expertise in antibodies and oncology, enhancing the company's growth trajectory [9][10] Question: How does PETO compare to competitors? - PETO is positioned as a potential best-in-class product with strong efficacy data, and the company plans to expand its clinical trials [15][16] Question: What are the expectations for Epkinly's market performance? - The company expects Epkinly to achieve peak year sales of $3 billion, contingent on successful expansion into earlier lines of therapy [24][28] Question: How will the company manage operating expenses with upcoming launches? - The company plans to invest strategically in areas with clear return opportunities while maintaining operational efficiency [55]

Core Insights - AbbVie is a leading player in the immunology sector, driven by three major drugs: Skyrizi, Rinvoq, and Humira, which collectively contribute to nearly 50% of the company's revenue [1] - Following the loss of U.S. exclusivity for Humira in 2023, AbbVie has experienced a strong recovery, primarily due to the increasing sales of Skyrizi and Rinvoq [2][3] Sales Performance - The combined sales of Skyrizi and Rinvoq have increased by 53% year-over-year, reaching $18.5 billion [3][9] - AbbVie anticipates that the combined sales of these two drugs will exceed $25 billion by 2025 and surpass $31 billion by 2027 [4][9] Market Position and Growth Drivers - AbbVie has successfully launched Skyrizi and Rinvoq across major indications, including a new indication for atopic dermatitis, which has bolstered their market position [2][4] - The company is also expecting regulatory submissions for new indications for Rinvoq, which could add approximately $2 billion to peak-year sales [4] Competitive Landscape - AbbVie faces competition from Johnson & Johnson, which markets Stelara and Tremfya, and Eli Lilly, which has recently entered the immunology market with Omvoh [6][7] Valuation and Stock Performance - AbbVie shares are currently trading at a slight discount to the industry average, with a price/earnings (P/E) ratio of 16.31 compared to the industry's 16.91 [11] - The stock has outperformed the industry year-to-date [8]

Core Insights - The company has undergone a significant transformation from focusing on anti-infectives to oncology, indicating a strategic pivot to a more lucrative market segment [3]. Group 1: Company Background - Summit has a long history, with the current leadership team having worked together for 10 to 20 years, showcasing stability and experience within the organization [4]. - The company initially invested in the anti-infective business but found it challenging to receive appropriate compensation for breakthroughs, leading to the shift towards oncology [3]. Group 2: Leadership and Team - The leadership team, including Co-CEO Robert Duggan, emphasizes the diverse skill set and flexibility of team members, which enhances the company's ability to evaluate and adapt to market needs [2]. - The integration of the team from Pharmacyclics signifies a strengthening of the company's capabilities in oncology, marking a transition to a second-generation leadership approach [3].

Summary of Xencor Conference Call Company Overview - **Company**: Xencor - **Industry**: Biopharmaceuticals, specifically focusing on protein engineering and bispecific antibodies - **Key Executives Present**: Basil Dahiyat (Co-founder, President, CEO), Dane Leone (Executive Vice President, Chief Strategy Officer) [1][2] Core Points and Arguments Expansion into Autoimmune Diseases - Xencor is re-entering the autoimmune disease space with the development of the anti-TL1A antibody, XmAb 942, after previously focusing on oncology [3][4] - The decision to return to autoimmune diseases was driven by the potential for creating differentiated clinical assets [4] - XmAb 942 is designed for high potency and long half-life, targeting TL1A, an inflammatory cytokine linked to inflammatory bowel diseases (IBD) [5][6] Clinical Data and Studies - Phase 1 data for XmAb 942 showed a half-life of over 71 days and sustained suppression of TL1A for over 16 weeks in healthy volunteers [7] - The ongoing Phase 2b study, XENITH-UC, aims to enroll approximately 220 patients to assess clinical remission in ulcerative colitis [11] - The study is designed to facilitate a seamless transition into registration-enabling studies, aiming for a competitive time to market [9] Future Developments - XmAb 412, a bispecific antibody targeting TL1A and IL-23, is expected to enter first-in-human trials in 2026 [10][12] - The combination of TL1A and IL-23 targeting is anticipated to enhance efficacy in IBD treatment [12][13] Other Autoimmune Programs - Xencor is also developing plamotamab, a CD20/CD3 bispecific antibody for rheumatoid arthritis (RA), leveraging their oncology experience to optimize dosing regimens [14][15] - XmAb 657, another bispecific targeting CD19/CD3, is in early development stages for myositis and other indications [16][17] Oncology Developments - XmAb 819, targeting ENPP3 in renal cell carcinoma, has shown a 25% overall response rate in heavily pretreated patients [23][24] - The company plans to expand the use of XmAb 819 into colorectal and lung cancers by 2026 [23][25] - XmAb 541, targeting CLDN6 in gynecologic tumors, is also progressing with early promising data [26][27] Partnerships and Collaborations - Xencor has established partnerships with Amgen and Johnson & Johnson, focusing on bispecific antibodies and other therapeutic areas [30][31] - The partnership with Amgen includes a phase 3 trial for Xaluritamig in metastatic castration-resistant prostate cancer, with potential royalties and milestones for Xencor [30] - Future partnerships are anticipated to enhance Xencor's capabilities and market reach [34][35] Additional Important Information - Xencor aims to be a commercial company, focusing on maximizing stakeholder value through strategic clinical development and potential partnerships [34][36] - The company is well-funded through 2028, allowing for flexibility in decision-making regarding asset management and partnerships [36] This summary encapsulates the key points discussed during the conference call, highlighting Xencor's strategic direction, clinical developments, and partnership strategies in the biopharmaceutical industry.

Financial Data and Key Metrics Changes - The company guided for approximately $150 million in sales for the first half of the year, with less than $100 million expected for the fourth quarter, indicating a strong start to the launch [2] - The operating margin improved to roughly 50% in the third quarter, reflecting a disciplined cost focus and operational efficiency [36][39] Business Line Data and Key Metrics Changes - The HIV prevention business collectively grew 42% year over year, with Descovy growing 32% year over year in HIV prevention [6] - Sunlenca's launch is expected to drive steady, consistent, durable growth similar to Biktarvy, which had $3.5 billion in sales in the third quarter [3] Market Data and Key Metrics Changes - The CDC estimates that at least 2.2 million people in the U.S. would benefit from HIV prevention, indicating a significant market opportunity [8] - Currently, about 500,000 people are on HIV prevention therapy, suggesting substantial room for market expansion [12] Company Strategy and Development Direction - The company is focused on changing prescriber habits and building awareness for the new injectable options versus oral medications [2][5] - There is a strong emphasis on expanding the HIV prevention market, with plans for specific advertising campaigns to raise awareness [5][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of the HIV prevention market, noting that the market is just beginning to develop [7][9] - The company highlighted the importance of building awareness and transitioning patients from existing therapies to new options [12][13] Other Important Information - The patent settlement for Biktarvy extends exclusivity until at least 2036, providing long-term stability for the company [15] - The company has a deep pipeline of next-generation HIV treatment alternatives, with multiple programs in clinical development [16][18] Q&A Session Summary Question: Can you discuss the strategy for educating patients and physicians on the benefits of the injectable option? - Management acknowledged that changing habits takes time and emphasized the importance of building a sales force and healthcare educators to raise awareness [5] Question: Where is the demand for Sunlenca coming from in the early days of the launch? - The company noted that there has been a surprising number of naive patients starting on Sunlenca, as well as patients switching from generic Truvada and other long-acting options [10][11] Question: What are the plans for Anito-cel in terms of clinical development? - Management confirmed that there are plans to move Anito-cel into earlier lines of treatment, with significant market opportunities identified [25][26] Question: Can you provide an update on Trodelvy's regulatory submissions and growth potential? - The company expects to receive an updated label for Trodelvy next year, which should drive significant growth [28] Question: How is the company approaching business development, particularly in China? - Management highlighted a shift towards innovative assets in China and noted that a significant portion of their corporate development interest is now sourced from that region [33][34]