Financial Data and Key Metrics Changes - The base business, excluding Veclury, grew 4% year over year, primarily driven by growth in the HIV business [6][50] - Total product sales, including Veclury, were down by 1% from last year, reflecting fewer COVID-19 related hospitalizations [8][50] - Non-GAAP diluted EPS was $1.81, with a product gross margin flat year over year at 85% [52][54] Business Line Data and Key Metrics Changes - HIV sales were up 6% year over year, with Biktarvy sales increasing by 7% [7][22] - Livedelzi achieved first-quarter sales of $40 million, reflecting early momentum in its launch [27] - Veclury sales were down 45% year over year, reflecting lower rates of COVID-19 related hospitalizations [28] - Trodelvy sales were down 5% year over year, impacted by inventory dynamics and lower average realized price [29][98] - Cell therapy sales were down 3% year over year, with Yescarta sales up 2% year over year [31] Market Data and Key Metrics Changes - The HIV treatment market continues to grow at an expected rate of 23% annually [22] - Descovy sales increased by 38% year over year, driven by higher average realized price and demand [23][78] - The liver disease segment saw sales of $758 million, up 3% year over year [26] Company Strategy and Development Direction - The company is focused on multiple upcoming launches, including lenacapavir, anetocel, and Trodelvy [13][34] - Gilead Sciences, Inc. has no major loss of exclusivity (LOE) until the end of 2033, positioning itself for top-line growth across therapeutic areas [14] - The company is increasing investment in US manufacturing and R&D infrastructure [15][89] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming FDA decision on lenacapavir for PrEP, with a potential launch immediately following [9][38] - The company remains well-positioned to adapt to potential policy outcomes in the US [14] - Management noted that the first quarter was lighter than expected but emphasized the variability of the business [54][93] Other Important Information - Gilead Sciences, Inc. received an upgrade in its long-term debt rating from BBB+ to A- [58] - The company returned $1.7 billion to shareholders in the first quarter of 2025 through dividends and share repurchases [58] Q&A Session Summary Question: Expectations for lenacapavir for PrEP and reimbursement dynamics - Management is excited about the upcoming PDUFA date and expects around 75% access within the first six months post-launch, reaching about 90% at the twelve-month mark [62] Question: Impact of HHS and CDC cuts on launch dynamics - Management has not seen anything that would alter plans for the lenacapavir launch and is actively engaging with policymakers [68] Question: Implications of COVID-19 on Descovy and lenacapavir - Descovy saw a 38% growth year over year, driven by market development initiatives, which supports the opportunity for lenacapavir [78] Question: Tariff risks and US market supply - Management indicated that the majority of Gilead's IP is in the US, which suggests lower value for pharmaceutical imports, and they have invested significantly in US manufacturing [86][89] Question: Cannibalization of Descovy by lenacapavir - Management believes lenacapavir will attract both switch patients from daily orals and naive patients, potentially accelerating market growth [124]

Financial Performance - Total product sales, excluding Veklury, increased by 4% year-over-year (YoY) to $6.3 billion[9, 13] - Total HIV product sales increased by 6% YoY, driven by pricing and demand, reaching $4.6 billion[9, 13] - Biktarvy sales increased by 7% YoY, reaching $3.1 billion[9, 17] - Descovy sales increased significantly by 38% YoY, reaching $586 million[9, 17] - Liver disease product sales increased by 3% YoY, reaching $758 million, driven by increased demand across PBC, HBV, and HDV products[13, 20] - Veklury sales decreased by 45% YoY to $302 million, reflecting lower COVID-19 related hospitalizations[13, 23] - Cell Therapy product sales decreased by 4% YoY to $464 million[13] Product & Pipeline Updates - Trodelvy sales decreased by 5% YoY to $293 million due to inventory dynamics and pricing[9, 13] - Livdelzi sales reached $40 million in Q125, showing continued launch momentum in PBC[9, 19] - Positive topline Phase 3 ASCENT-04 data evaluating Trodelvy + pembrolizumab in 1L PD-L1+ mTNBC[9] - Livdelzi received EU approval in February 2025 for PBC, including related pruritus[9, 38]

Core Insights - The weight loss therapy market is rapidly growing, with leading drugs like Wegovy and Zepbound gaining significant sales traction [1] - Pfizer has faced multiple setbacks in its attempts to enter the weight loss market, particularly with its candidates danuglipron and lotiglipron [2][3][5] Group 1: Pfizer's Weight Loss Drug Development - Pfizer discontinued lotiglipron after phase 1 studies due to potential liver issues [3] - The danuglipron program faced challenges, with a twice-daily version showing efficacy but high side effects, leading to its abandonment [4] - Pfizer scrapped the danuglipron project entirely after a phase 2 study indicated liver injury in a patient, marking a significant setback [5] Group 2: Future Prospects and Other Opportunities - Despite setbacks in the weight loss market, Pfizer is not exiting this area and will pursue other therapeutic options [6] - Pfizer's oncology market prospects are more promising, bolstered by the acquisition of Seagen for $43 billion, enhancing its cancer treatment capabilities [7][8] - Pfizer reported a 7% year-over-year revenue increase to $63.6 billion and a 69% rise in adjusted earnings per share to $3.11 [9] Group 3: Investment Considerations - Pfizer's strong financial performance and deep pipeline make it an attractive option for investors, despite recent challenges in the weight loss sector [10] - The stock offers a forward yield of 7.8%, with a 54% increase in dividends over the past decade, appealing to dividend-seeking investors [9]

Financial Data and Key Metrics Changes - The company reported encouraging clinical data for MRT-6160, mapping a clear path to Phase 2 studies, with a focus on achieving over 80% degradation of VAV1 and cytokine modulation between 82% to 99% [37][62]. - The company maintains a strong balance sheet, providing a cash runway anticipated into 2028 [65]. Business Line Data and Key Metrics Changes - MRT-6160 demonstrated a dose-dependent pharmacokinetic profile with over 90% VAV1 degradation in T cells after administration, consistent with preclinical studies [15][20]. - The NEK7 program is on track for an IND submission in the first half of the year, with plans for clinical proof of concept trials in various inflammatory conditions [26][64]. Market Data and Key Metrics Changes - The company is focusing on the oncology market, particularly in castration-resistant prostate cancer, where early signs of clinical response have been observed [51][54]. - The NEK7 program targets the NLRP3 inflammasome, which is critical in many inflammatory conditions, indicating a broad potential market for the drug [24][34]. Company Strategy and Development Direction - The company aims to expand its portfolio of oral immunology and inflammation (I&I) drugs, leveraging its clean platform for drug discovery [35][62]. - There is a strategic focus on developing MRT-2359 for prostate cancer, with plans to prioritize this indication over others due to its significant unmet need [54][63]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety profile of MRT-6160, with no serious adverse events reported in the Phase 1 study [20][21]. - The management is optimistic about the potential of MRT-8102 and plans to submit an IND in the first half of the year, indicating a proactive approach to clinical development [64][65]. Other Important Information - The company has established a strategic development agreement with Novartis for MRT-6160, aiming to accelerate its development [10][11]. - The preclinical data for MRT-8102 shows a favorable safety margin, supporting its advancement into clinical trials [30][31]. Q&A Session Summary Question: On VAV1, how does the company decide on the most promising indications to pursue? - The company is still preparing for Phase 2 studies, with preclinical data suggesting strong potential in indications driven by T and B cells, such as ulcerative colitis and rheumatoid arthritis [70][71]. Question: How does ex vivo simulation differ from in vivo measurement? - The company indicated that the exact percentage of in vivo biomarker reduction will depend on the disease type, but they are confident in the molecule's ability to achieve significant effects in patients [74][75]. Question: What is the ideal application for MRT-2359 in prostate cancer? - The company sees potential in targeting both castrate-resistant and castrate-sensitive prostate cancer, with a focus on combinations with androgen receptor inhibitors [78][80]. Question: How does the company compare its cytokine inhibition to other therapies? - The company believes it compares favorably to BTK inhibitors and IL-17 antagonists, achieving up to 99% inhibition in healthy volunteers [89][90]. Question: What are the interim factors for expanding the prostate cancer cohort? - The company mentioned an interim efficacy assessment is in place before expanding enrollment, considering the heavily pretreated nature of the patient population [92][93]. Question: What are the expected on-target side effects for VAV1? - The company does not anticipate significant on-target toxicities based on preclinical data, but acknowledges a potential risk of infections [105][106]. Question: How does GSPT1 degradation correlate with clinical activity? - The company noted that the responder in the biomarker-positive group was a neuroendocrine bladder cancer patient, indicating that high N-MYC expression is a good target, although such patients are rare [108][109].

Core Viewpoint - Pfizer is experiencing a transition phase with declining COVID product sales but growth in non-COVID drugs and new acquisitions, positioning the company for future operational growth [2][3][17]. Sales Performance - Sales of Pfizer's COVID products, Comirnaty and Paxlovid, are projected to decline to approximately $11 billion in 2024 from $56.7 billion in 2022, with similar revenues expected in 2025, excluding one-time benefits [3]. - Non-COVID operational revenues improved by 12% in 2024, surpassing the guidance range of 9-11%, driven by key products and new acquisitions [4]. Growth Drivers - Pfizer's acquisition of Seagen and the performance of its oncology drugs, which generated $3.4 billion in sales in 2024 (up 38% pro forma), are significant contributors to growth [6][7]. - The oncology segment accounts for about 25% of total revenues, with a 26% operational growth in 2024, supported by drugs like Xtandi and Padcev [7]. Stock Performance and Valuation - Pfizer's stock has risen 5.9% over the past three months, although it has declined 9.8% in the last six months, underperforming the industry [1][8]. - The stock is trading at a forward price/earnings ratio of 9.0, lower than the industry average of 17.51 and its own 5-year mean of 11.11, indicating an attractive valuation [10]. Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings has increased from $2.93 to $2.97 per share, while the estimate for 2026 has decreased from $3.04 to $2.99 per share [11]. Future Outlook - Pfizer anticipates continued growth in non-COVID sales and significant cost reductions, aiming for savings of at least $6 billion, which should support profit growth [17]. - The company returned $9.5 billion to shareholders through dividends in 2024, with a dividend yield of around 6.4%, making it appealing for long-term investors [18].

Core Viewpoint - AbbVie is expanding its presence in the obesity treatment market by in-licensing GUB014295, a long-acting amylin analog, from Gubra, with a total potential deal value of $2.225 billion [1][2][3] Industry Overview - The obesity market is projected to reach $100 billion by 2030, with current dominance by GLP-1 drugs from Eli Lilly and Novo Nordisk [3] - Major pharmaceutical companies, including Merck, Pfizer, Amgen, and AstraZeneca, are actively pursuing opportunities in the obesity space through in-house development or licensing deals [3] AbbVie's Product Performance - AbbVie has successfully launched Skyrizi and Rinvoq, generating combined sales of $17.7 billion in 2024, particularly excelling in the inflammatory bowel disease market [5][6] - The company anticipates combined sales of Skyrizi and Rinvoq to exceed $31 billion by 2027, driven by market growth and new indications [7] Pipeline and Acquisitions - AbbVie has a robust pipeline with several early/mid-stage candidates and expects multiple regulatory submissions and approvals in the next 12 months [8][9] - The company has been active in acquisitions, signing over 20 early-stage deals in 2024 to enhance its pipeline in immunology, oncology, and neuroscience [11][12] Sales Trends and Challenges - AbbVie is experiencing declining sales from Humira due to biosimilar competition, with a sharper decline expected in 2025 [13] - The aesthetics portfolio, including Juvederm fillers, has also seen a decline, with a 14.6% drop in sales in 2024 [14][15] Stock Performance and Valuation - AbbVie stock has outperformed the industry with a 14.8% increase over the past year [16][18] - The stock trades at a price/earnings ratio of 16.52, slightly below the industry average of 17.80, but higher than many large drugmakers [19][20] Earnings Estimates - The Zacks Consensus Estimate for AbbVie's 2025 earnings has increased from $12.24 to $12.29 per share, indicating positive sentiment [22]

Group 1 - The company is in a strong position, supported by a robust portfolio of commercial products addressing significant medical needs [2] - Growth expectations for 2025 are driven by strengths in oncology, animal health, and new product launches, which are anticipated to offset challenges from GARDASIL in China [3] - The company aims to sustain strong growth into 2026 and 2027, with a focus on execution and performance of existing and new products [3]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 KAZIA THERAPEUTICS LIMITED (Exact name of Registrant as specified in its charter) As filed with the Securities and Exchange Commission on January 30, 2024 (State or other jurisdiction of incorporation or organization) Registration No. 333- Australia 2834 Not applicable (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identificatio ...