Core Viewpoint - Puma Biotechnology's shares have declined by 9.6% over the past month due to concerns regarding a weak revenue outlook for 2026 [1][7]. Company Overview - Puma Biotechnology's only marketed product is Nerlynx (neratinib), which is approved for treating early-stage HER2-positive breast cancer and advanced or metastatic HER2-positive breast cancer [2]. - Nerlynx sales accounted for the majority of Puma's revenue, with sales increasing by 4.6% year-over-year to $204.1 million in 2025 [3]. 2026 Financial Outlook - For 2026, Puma Biotechnology expects total revenues to be between $214 million and $221 million, with Nerlynx sales projected to be between $194 million and $198 million [4][7]. - The guidance indicates a cautious growth trajectory for Nerlynx, reflecting a conservative demand outlook [4]. Pipeline Developments - Puma is developing alisertib, an aurora kinase A inhibitor, in mid-stage studies for hormone receptor-positive breast cancer and small-cell lung cancer [8][9]. - Initial phase II data for alisertib is expected in Q2 2026, which could enhance the company's position in the anti-cancer drug market if successful [9]. Competitive Landscape - Puma Biotechnology relies solely on Nerlynx for revenue, raising concerns about its growth potential amid intense competition from other approved treatments like Roche's Herceptin and Novartis' Tykerb [10]. - The bearish outlook for 2026, combined with competition and potential setbacks in ongoing studies, poses challenges for the company [11].

Core Insights - Ironwood Pharmaceuticals (IRWD) and Puma Biotechnology (PBYI) are small-cap biotech firms heavily reliant on a single key drug while attempting to expand their limited pipelines [1][2] Ironwood Pharmaceuticals (IRWD) - Ironwood's primary product, Linzess (linaclotide), is approved for treating irritable bowel syndrome with constipation (IBS-C) and functional constipation, marketed in collaboration with AbbVie [3][4] - Linzess sales faced a decline of 15% year-over-year in 2025, attributed to gross-to-net rebate adjustments and pricing pressure, despite strong prescription demand [5][6] - Ironwood anticipates a revenue rebound in 2026, projecting total revenues of $450-$475 million, representing a 54% year-over-year increase at the midpoint [6][10] - The company is developing apraglutide for short bowel syndrome, with a confirmatory phase III study expected to start in Q2 2026 [7][8] - Ironwood's 2026 earnings per share (EPS) estimates indicate a significant increase of around 533%, with positive trends in EPS estimates [16][28] - Year-to-date, IRWD shares have increased by 9.2%, trading at a price-to-sales (P/S) ratio of 2.02, indicating a premium valuation compared to PBYI [21][22][28] Puma Biotechnology (PBYI) - Puma's sole marketed product, Nerlynx, is approved for early-stage HER2-positive breast cancer and has seen a 4.5% year-over-year sales increase to $204.1 million in 2025 [11][12] - Despite rising demand, PBYI issued a weaker-than-expected 2026 financial outlook, projecting total revenues of $214-$221 million and net product revenues from Nerlynx between $194 million and $198 million [12][13] - PBYI is developing alisertib for hormone receptor-positive breast cancer and small-cell lung cancer, with interim data expected in Q2 2026 [14] - The Zacks Consensus Estimate for PBYI's 2026 EPS implies a year-over-year decrease of 36%, with downward trends in EPS estimates [18][28] - Year-to-date, PBYI shares have risen by 0.8%, with a P/S ratio of 1.35, indicating a lower valuation compared to IRWD [21][22] Comparative Analysis - Ironwood holds a Zacks Rank 3 (Hold), while Puma Biotechnology has a Zacks Rank 4 (Sell), suggesting a more favorable outlook for IRWD [25][28] - Ironwood's strategy of strengthening the Linzess franchise and advancing apraglutide positions it for long-term growth, contrasting with PBYI's reliance on a single product and muted outlook [27][28]

Summary of Puma Biotechnology FY Conference Call Company Overview - **Company**: Puma Biotechnology (NasdaqGS: PBYI) - **Key Product**: NERLYNX (neratinib), FDA approved for HER2-positive breast cancer - **Pipeline Drug**: Alisertib, an Aurora kinase inhibitor in clinical trials Key Points Product Pipeline - NERLYNX is approved for both extended adjuvant and metastatic HER2-positive breast cancer based on Phase III trials (ExteNET and NALA) [4][30] - Alisertib is in two Phase II trials: ALISCA-Breast for HER2-positive and HER2-negative metastatic breast cancer, and ALISCA-Lung for small cell lung cancer [4][30] Commercialization and Revenue - NERLYNX generated **$59.9 million** in Q4 2025, up from **$54.4 million** in Q4 2024 and **$51.9 million** in Q3 2025 [5][6] - Total bottles sold in Q4 2025: **3,298**, compared to **2,964** in Q4 2024 and **2,949** in Q3 2025 [6] - Expected revenue for full year 2026: **$214 million - $221 million**, with a net income of **$10 million - $13 million** [9] Market Potential - U.S. market for NERLYNX in the extended adjuvant setting: approximately **28,300** patients with early-stage HER2-positive breast cancer [8] - In the EU, about **37,000** patients with early-stage HER2-positive breast cancer, with **65%-70%** being HR-positive [8] Clinical Trials and Efficacy - Alisertib shows promise in various cancers, with a focus on HR-positive, HER2-negative breast cancer and small cell lung cancer [12][19] - In previous trials, alisertib demonstrated a **23%** objective response rate in HR-positive, HER2-negative breast cancer [14] - Ongoing studies aim to optimize dosing and evaluate biomarkers for better efficacy [18][24] Intellectual Property - NERLYNX patents extend to **2030**, with additional use patents until **2031** [25] - Alisertib's composition patent extends to **2029**, with further extensions for specific uses until **2034** [26] Financial Health - Cash and cash equivalents at the end of December: **$97.5 million** [29] - The company has maintained profitability since 2016, with a focus on staying net income positive [41][42] Future Milestones - Interim data from ALISCA-Breast1 and ALISCA-Lung1 trials expected in **2026** [27] - Full data from ALISCA-Breast1 anticipated in **Q4 2026** [28] Management and Governance - CEO: Alan Arak, with a diverse board covering commercial, clinical, finance, and regulatory aspects [28] Additional Insights - The FDA's preference for randomized studies over single-arm approvals may impact future drug approval strategies [36] - The company is exploring biomarker-directed approaches to enhance treatment efficacy [36][40] This summary encapsulates the key points discussed during the Puma Biotechnology FY Conference Call, highlighting the company's product pipeline, commercialization efforts, market potential, clinical trial outcomes, financial health, and future milestones.

Core Insights - Puma Biotechnology (PBYI) reported fourth-quarter 2025 adjusted earnings of 29 cents per share, exceeding the Zacks Consensus Estimate of 24 cents, but down from 43 cents in the same quarter last year [1] - Total revenues for the fourth quarter reached $75.5 million, surpassing the Zacks Consensus Estimate of $68 million, and reflecting a 28% year-over-year increase [2] Financial Performance - Product revenues from Nerlynx totaled $59.9 million in Q4, up nearly 10% year over year, beating estimates of $54 million [4] - Royalty revenues surged 232% year over year to $15.6 million [4] - Total operating costs for the quarter were $58.4 million, an increase of 28% year over year [4] - For the full year 2025, total revenues were $228.4 million, slightly down from $230.5 million in the previous year [6] Guidance and Projections - For 2026, net product revenues are projected to be between $194 million and $198 million, with total revenues expected to range from $214 million to $221 million, which is below the Zacks Consensus Estimate of $235.7 million [7][8] - The company anticipates a net loss of approximately $8 million to $10 million for Q1 2026 [12] Pipeline Developments - Puma Biotechnology is developing alisertib, an aurora kinase A inhibitor, for hormone receptor-positive breast cancer and small-cell lung cancer [13] - The company is conducting a phase II study (ALISCA-Lung1) for alisertib as a monotherapy for extensive-stage SCLC, with interim data expected in Q2 2026 [14] - Another phase II study (ALISCA-Breast1) is underway for alisertib in combination with endocrine treatment for HER2-negative, hormone receptor-positive metastatic breast cancer, with initial data also expected in Q2 2026 [15] Market Performance - PBYI's shares have increased by 154.2% over the past year, compared to the industry's rise of 19.9% [9]

Core Insights - Puma Biotechnology reported a total revenue of $75.5 million for Q4 2025, driven by NERLYNX product revenue of $59.9 million and a significant increase in royalty revenue to $15.6 million [5][4][7] Financial Performance - Q4 2025 product revenue net, consisting entirely of NERLYNX sales, totaled $59.9 million, an increase from $51.9 million in Q3 2025 and $54.4 million in Q4 2024 [4] - GAAP net income for Q4 2025 was $13.4 million, or $0.20 per basic share, compared to $8.8 million in Q3 2025 [19] - Non-GAAP net income for Q4 2025 was $15.1 million, or $0.30 per basic share, excluding stock-based compensation [19] - Gross revenue from NERLYNX sales was $82.9 million in Q4 2025, up from $70.0 million in Q3 2025 [20] Inventory and Sales Dynamics - Management noted an inventory build of approximately $5.7 million at specialty pharmacies, impacting Q4 product revenue [3][7] - New prescriptions decreased by about 11.4% compared to Q3 2025, while total prescriptions increased by 1.4% [2] Clinical Development - The ALISCA-Breast1 trial for alisertib reached enrollment ahead of schedule with 164 patients, and interim data is expected in Q2 2026 [6][15] - The ALISCA-Lung1 trial is examining alisertib monotherapy, with preliminary data suggesting better activity in patients with relevant biomarkers [16] Guidance and Future Outlook - For 2026, Puma expects net NERLYNX product revenue of $194–$198 million and royalties of $20–$23 million, with a projected net income of $10–$13 million [7][22] - Q1 2026 guidance includes net NERLYNX product revenue of $36 million to $39 million and a projected net loss of $8 million to $10 million [23] Marketing and Sales Strategy - The sales team is focused on expanding healthcare provider reach, with Q4 2025 call activity increasing by 23% year over year [8] - NERLYNX demand increased by about 7% quarter over quarter and 7% year over year, with specialty distributor demand growing by 17% sequentially [9][10] Cost and Cash Management - Cost of sales in Q4 2025 was $23.2 million, including $2.4 million of amortization related to the neratinib license [21] - Puma generated approximately $3.1 million of cash in Q4 2025, with outstanding principal debt declining to approximately $22 million [25]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $75.5 million, with product revenue net of $59.9 million, an increase from $51.9 million in Q3 2025 and $54.4 million in Q4 2024 [5][21] - 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 [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 [30] - Total prescriptions for NERLYNX increased by approximately 1.4% quarter-over-quarter, while new prescriptions decreased by about 11.4% [6][24] - NERLYNX ex-factory bottle sales were 3,298 in Q4 2025, representing a 12% increase quarter-over-quarter [22] Market Data and Key Metrics Changes - The distribution model showed that 63% of business was purchased through the specialty pharmacy (SP) channel, while 37% was through the specialty distributor (SD) channel [19] - Demand in the SD channel grew by about 17% quarter-over-quarter and 46% year-over-year [24] 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] - 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 [38] - The company anticipates net NERLYNX product revenue for fiscal year 2026 to be in the range of $194 million to $198 million [32] 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 [36] - The company plans to initiate a second trial of alisertib in small cell lung cancer [14] 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 [42] - It was mentioned that inventory usually burns off in the first quarter following the fourth quarter build [43]

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]

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][22][29] - Royalty revenue reached $15.6 million in Q4 2025, compared to $2.6 million in Q3 2025 and $4.7 million in Q4 2024 [6][31] - Net income based on GAAP was $13.4 million, or $0.20 per basic share, compared to $8.8 million in Q3 2025 [28][29] 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 [30] - Total prescriptions for NERLYNX increased by approximately 1.4% quarter-over-quarter, while new prescriptions decreased by about 11.4% [6][24] - NERLYNX ex-factory bottle sales were 3,298 in Q4 2025, representing a 12% increase quarter-over-quarter [23] 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 [21] - Stronger growth was observed in the SD channel, driven by increased sales in group purchasing organizations and 340B purchasing [21] Company Strategy and Development Direction - The company is focused on expanding NERLYNX's market presence and increasing awareness among healthcare professionals [18] - Puma is evaluating several drugs for potential in-licensing or acquisition to diversify its portfolio [17] - The company plans to initiate a second trial of alisertib in small cell lung cancer, indicating a commitment to expanding its clinical pipeline [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving positive net income for the full year 2026, attributing this to financial discipline [39][40] - The company acknowledged the significant unmet need for patients with breast cancer and lung cancer, emphasizing its commitment to addressing these challenges [41] Other Important Information - The company anticipates net NERLYNX product revenue for fiscal year 2026 to be in the range of $194 million to $198 million [32] - SG&A expenses were reported at $18.4 million in Q4 2025, an increase from $16.8 million in Q3 2025 [35][36] 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 [44] - It was mentioned that inventory usually burns off in the first quarter following the fourth quarter build [45][46]

Drug Approvals and Market Potential - NERLYNX is currently approved in the United States for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer and for use in combination with capecitabine for advanced or metastatic HER2-positive breast cancer [22]. - As of December 31, 2025, NERLYNX has received approval in over 40 countries outside the United States, including the European Union, China, and Australia [23]. - The FDA has approved NERLYNX (neratinib) for extended adjuvant treatment of early stage HER2-positive breast cancer, based on two-year data from the ExteNET trial [32]. - NERLYNX was launched in the United States in July 2017 and received approval in February 2020 for use in combination with capecitabine for advanced or metastatic HER2-positive breast cancer [105]. - Neratinib received marketing approval in the U.S. on July 17, 2017, providing five years of regulatory exclusivity [112]. - In the U.S., neratinib in combination with capecitabine received marketing approval on February 25, 2020, granting three years of regulatory exclusivity [112]. - In Europe, neratinib obtained marketing approval on August 31, 2018, which provides 10 years of regulatory exclusivity [112]. - Between 2019 and 2024, marketing approvals for neratinib were obtained in multiple countries including Argentina, Brazil, and China [112]. - The company is pursuing commercialization of NERLYNX in Europe and other countries, with various approvals across multiple regions for both extended adjuvant and metastatic treatments [108]. - In 2022, an estimated 2.3 million new breast cancer cases and 670,000 related deaths occurred globally, highlighting the market potential for HER2-targeted therapies [26]. Clinical Trials and Efficacy - The ExteNET trial enrolled 2,840 patients across 41 countries, demonstrating a 33% reduction in the risk of invasive disease recurrence or death with neratinib compared to placebo (hazard ratio = 0.67, p = 0.009) [35]. - The two-year disease-free survival (DFS) rate for the neratinib arm was 93.9%, compared to 91.6% for the placebo arm [35]. - In the five-year follow-up of the ExteNET trial, neratinib showed a 27% reduction in the risk of invasive disease recurrence or death (hazard ratio = 0.73, p = 0.008), with a five-year iDFS rate of 90.2% for neratinib versus 87.7% for placebo [38]. - For hormone receptor-positive patients, the five-year iDFS rate was 91.2% for neratinib compared to 86.8% for placebo, indicating a 40% reduction in risk of invasive disease recurrence or death (hazard ratio = 0.60, p = 0.002) [39]. - The Phase III NALA trial showed a statistically significant improvement in progression-free survival (PFS) for neratinib plus capecitabine with a hazard ratio of 0.76 (p=0.0059) [52]. - The median overall survival (OS) for patients treated with neratinib plus capecitabine was 21.0 months, compared to 18.7 months for lapatinib plus capecitabine [53]. - The overall cumulative incidence of CNS metastases was 22.8% for the neratinib plus capecitabine arm, compared to 29.2% for the lapatinib plus capecitabine arm (p=0.043) [54]. - In the TBCRC 022 trial, 49% of patients experienced a CNS Objective Response by composite criteria, with a median overall survival of 13.5 months [61]. Adverse Events and Management - The most common adverse event for neratinib-treated patients was diarrhea, with about 39.9% experiencing grade 3 or higher diarrhea [34]. - The CONTROL trial is investigating the use of antidiarrheal prophylaxis or dose escalation to reduce neratinib-associated diarrhea [45]. - The incidence of grade 3 diarrhea for patients receiving loperamide prophylaxis was 31%, while it was 28% for those receiving loperamide plus budesonide, and 21% for loperamide plus colestipol [47]. - The adoption of neratinib dose escalation regimen 1 (DE1) resulted in a significantly lower incidence of grade 3 diarrhea at 13%, compared to the historical control of 39.8% from the ExteNET trial [47]. - The median cumulative duration of grade 3 diarrhea was reduced to 2-2.5 days in the CONTROL DE study cohorts, compared to 5.0 days in the ExteNET trial [47]. - The proportion of patients discontinuing neratinib due to diarrhea was lower in DE cohorts, with DE1 at 3% and DE2 at 6%, compared to 17% in ExteNET [47]. Research and Development Strategies - The company aims to maximize the value of its programs by maintaining flexibility in commercialization strategies, including independent sales or partnerships [25]. - The company plans to in-license or acquire additional drugs and technologies to build a sustainable product pipeline [25]. - The company is focused on advancing the development of alisertib in hormone receptor-positive breast cancer and small cell lung cancer [25]. - The ongoing Phase II trial for alisertib in small cell lung cancer aims to enroll up to 60 patients and analyze biomarkers [81]. - The primary endpoint of the ALI-4201 trial is objective response rate, with secondary endpoints including PFS and overall survival [82]. - The company initiated a Phase II trial of alisertib in combination with endocrine treatment for chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer, actively enrolling patients as of November 2024 [94]. - The ALISCATM-Breast1 trial aims to enroll a total of 150 patients, with expectations to exceed this number due to a larger screening pool [95]. Financial Obligations and Licensing Agreements - The company has entered into an exclusive license agreement with Takeda for alisertib, which has shown activity in various cancers and was tested in over 1,300 patients across 22 trials [24]. - The company is obligated to make milestone payments totaling approximately $187.5 million to Pfizer upon achieving certain milestones, with a one-time payment of $12.5 million triggered by worldwide net sales of $250.0 million in 2022 [125][127]. - The company paid a milestone payment of $1.8 million, including accrued interest, in September 2021, and the royalty obligation to Pfizer is set at a fixed rate in the low-to-mid teens of net sales for licensed products [125][128]. - In September 2022, the company entered into an exclusive license agreement with Takeda, paying an upfront fee of $7.0 million and potentially up to $287.3 million in future milestone payments [130]. - The company has received an upfront payment of $50.0 million from Pierre Fabre and may receive additional milestone payments up to $240.0 million based on regulatory and sales activities in the Third Pierre Fabre Territory [150]. - The company is entitled to receive double-digit royalties on net sales of licensed products in both the Licensee Territory and the Third Pierre Fabre Territory [150]. - The Specialised Therapeutics Agreement allows the company to receive double-digit royalties on sales of licensed products throughout the STA Territory, with STA responsible for regulatory and commercialization activities [135]. - The Knight Agreement includes potential regulatory and commercial milestone payments, along with double-digit royalties on sales of licensed products in the Knight Territory [146]. Regulatory Environment and Compliance - The company must comply with extensive regulatory requirements throughout the drug development process, including pre-clinical tests, clinical trials, and manufacturing compliance [157]. - The FDA review process for new drug applications (NDAs) typically takes about 10 months from the filing date for a new molecular entity, with a total review time of approximately 12 months [167]. - The FDA may grant orphan drug designation for drugs intended to treat rare diseases, which can provide exclusivity for seven years upon first approval for the designated condition [174]. - The FDA mandates that approved NDA holders report adverse reactions and maintain pharmacovigilance programs, ensuring compliance with cGMPs [181]. - The EU Clinical Trials Regulation (CTR) harmonizes clinical trial assessments across member states, allowing for a single application for multi-center trials [191]. - Medicines used in clinical trials in the EU must comply with GMP, and the approval process varies by country, potentially requiring additional testing [193]. - The EMA evaluates marketing authorization applications (MAAs) within a maximum of 210 days, with potential for accelerated review in exceptional cases [197]. - All new MA applications must include a risk management plan (RMP) to document measures for minimizing risks associated with the product [205]. - The advertising and promotion of medicinal products must comply with EU directives and member state regulations, prohibiting off-label promotion and direct-to-consumer advertising of prescription medicines [206]. - Non-compliance with EU laws regarding clinical trials and product marketing can result in severe penalties, including delays in MA and product withdrawals [207].

Puma Biotechnology Earnings Call Commercial Update February 26, 2026 Forward-Looking Safe-Harbor Statement This presentation contains forward-looking statements, including statements regarding commercialization of NERLYNX® and the potential indications and development of our drug candidates. All forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These ...