Bliss GVS Pharma Ltd Management Discussions

Annexure - VII to Boards Report

Global economic overview

The global economic environment of CY23 recorded significant positive developments amidst ongoing geopolitical tensions. With inflation falling to 6.8% coupled with GDP growth of 3.2%, the economy has outperformed the predictions of the International Monetary Fund (IMF). Effective monetary policies resulting in reduced energy prices and increased expenditures, stimulating consumption, have propelled the growth of the economy, especially in the United States and other key emerging nations. Geopolitical turmoil has led to fluctuations in commodity prices worldwide, however, with the normalising of supply chains, shipping costs have reduced notably. It is expected for advanced economies such as the US to adopt more relaxed fiscal policies in the coming years. The adoption of more lenient fiscal policies than the Eurozone and other economies currently in recovery has already led the United States to exceed pre-pandemic GDP levels impressively.

Outlook

The global economy is poised on a delicate growth trajectory. It is expected for the global economy to maintain the growth of 3.2% in 2024 and then follow the same trajectory of 3.2% in 2025. While there is improvement, the growth still fails to meet the expected demand, owing to factors such as implementation of strict monetary policies, reduced fiscal support and subdued productivity. However, the US economy is expected to surpass the IMFs predictions in the upcoming financial years. Advanced economies facing an initial dip, are expected to rebound in 2025. On the other hand, emerging markets and developing economies are projected to maintain stable growth trajectories. The global inflation is forecasted to decrease from 6.8% in 2023 to 5.9% in 2024 imDlvina Dositive develomrients in the suddIv chains.

Indian economic overview

Despite persistent inflation, India remained one of the worlds fastest-growing economies in FY24. India observed a rise in inflation from a low of 4.9% in October 2023 to 5.7% in December of that same year, however, a reduction in inflation to 5.1% was recorded in January 2024 due to positive development in the food industry. The Indian economy showed remarkable resilience in the face of adversity, competing against global peers. The economy grew by 8.2% in FY24.

India, utilising its G20 chair, has relentlessly promoted substantial multilateral efforts. In the times of global crisis, Indias banking industry demonstrated resilience and have substantially driven the economys growth by incorporating effective monetary policies. Current statistics indicate continuous growth in the upcoming financial years as well.

Industry and services sectors have played pivotal roles in accelerating the upward trajectory of the Indian economy, positioning the country as a frontrunner among both advanced and emerging market economies. The IMF predicts India is enroute to become the worlds third-largest economy by 2027 (measured in USD at market exchange rates). Indias contribution to global economic growth is expected to increase by 200 basis points over the next five years, underscoring its expanding influence on the international stage.

Outlook

The Indian Governments fiscal policy for FY25 aims at strengthening the domestic economy and maintaining macroeconomic stability amidst potential external challenges. Focusing on inclusivity and sustainability, the strategy intends to equip the economy to navigate unforeseen headwinds effectively. A significant capital is allocated towards sustaining infrastructure development and preparation of a collaborative approach towards fiscal federalism to support state-level initiatives. Priority is given to key sectors such as healthcare, education, agriculture and rural development, ensuring sustainable growth and a better future. Resource allocation systems are innovated to optimise cash management, reflecting the governments commitment to strengthen the Indian economy and foster a comprehensive development across all sectors.

Industry overview

Global pharmaceutical industry

The financial year of 2024 witnessed the global pharmaceutical business undergoing considerable transformations in the midst of several headwinds. Significant disruptions in the healthcare market resulted in a fundamental shift to the bygone business strategies. Economic restrictions, increased competition and stringent policies have dictated industry growth and altered market expectations. The current scenario predicts augmentation of the healthcare delivery system in the future, resulting in the development of diverse healthcare system and changing in the dynamics of medical purchases. The change in the demography with the increase in the number of ageing patients and evolving requirements are driving the growth of the industry. Regulatory policies like the Inflation Reduction Act in the United States has forced pharmaceutical corporations to reassess their research and development strategies, pricing structures and market expansion techniques.

Key highlights

• Growth for COVID-19 vaccines and treatment has improved by two percentage points, despite a low prediction

• The growth rise can be attributed to patients receiving better treatments, particularly in immunology, endocrinology and oncology.

• Over the next five years, Latin America and Asia will see an increase in medicine consumption compared to other regions.

• Global pharmaceutical usage increased by 14% during the last five years, with a further expected 12% increase by 2028, reaching 3.8 trillion defined daily doses each year.

• Global spending on medicines at marked prices has climbed by 35% in the last five years and is expected to rise by 38% by 2028.

• The updated projection for the US market, based on predicted net prices, has been revised by 3 percentage points to a 2-5% CAGR through 2028, indicating stronger recent growth and expected greater patient use of higher value medications.

Spending and growth by regions

• Health System modifications: Governments in the United States and the European Union are implementing policies to mediate drug prices and improve access to healthcare services.

• Demographic changes: An increase in the number of elderly people in countries such as Spain, Switzerland, South Korea and China has increased the demand for preventative care investments to reduce future healthcare costs.

• Shifting Patient Experiences: Despite increased trust in pharmaceuticals, the public is yet to form a consolidated opinion on the business. Companies are relentlessly implementing patient engagement techniques and advanced technologies such as generative AI and blockchain to suit changing consumer demands and to optimise experiences.

Spending and growth by regions

• Healthcare Mergers and Acquisitions: In the light of increase in consolidations in 2024, there is a notable emphasis on system-wide drug placements in healthcare M&A industry.

• Cybersecurity Focus: The upsurge in digital attacks on pharmaceutical companies highlights the requisite for enhanced cybersecurity efforts to protect sensitive patient data and continuous business operations.

• Advances in AI: The advancement in technology, including generative AI techniques, has altered drug development procedures, making it easier to identify novel chemical structures and improve predictive scientific research.

• Regenerative Medicine: The creation of innovative medications facilitating gene and cell therapies, creates new complications and regulatory issues; it has become a necessity for regulatory frameworks to align with the scientific advances.

Indian pharmaceutical industry

The Indian pharmaceutical industry plays a prominent role in the global market. Being one of the biggest suppliers of economical vaccines in the world, India occupies 20% of the global supply share by volume. The country accounts for 60% of global vaccine production which contributes to 70% of the WHOs demand for Diphtheria, Tetanus and Pertussis (DPT) and Bacillus Calmette-Guerin (BCG) vaccines, and 90% of the WHOs demand for the measles vaccine. The pharmaceutical industry is currently at a value of USD 50 billion and is expected to reach USD 65 billion by CY24 and USD 130 billion by CY30. India is a major exporter of pharmaceuticals with its distribution expanding over 200+ countries. India meets 50% of Africas and 40% of the USAs demand for generics.

Government initiatives

• Government Schemes: The Indian government has implemented several schemes and initiatives to bolster the pharmaceutical industry. The Strengthening of Pharmaceuticals Industry (SPI) scheme, the Production Linked Incentive (PLI) for pharmaceuticals and for the promotion of domestic manufacturing of critical Key Starting Materials (KSMs)/Drug Intermediates and Active Pharmaceutical Ingredients (APIs) have driven the growth of the industry effectively. Additionally, schemes like the promotion of Bulk Drug Parks aim to enhance productivity, quality and competitiveness while encouraging domestic manufacturing of vital inputs and intermediates.

• Research and Development Support: Government- backed research and development aid in continuous innovation to meet the evolving needs of the consumers.

The National Policy on Research and Development and Innovation in the Pharma-MedTech Sector allocates substantial financial aid to the industry, encouraging collaborations between industries, MSMEs, SMEs, startups and government institutes. The policy emphasises upon industry-academia partnerships, key focus areas, product development and affordable healthcare solutions. This will foster innovation, strengthen research capabilities and position India as a global leader in pharmaceutical R&D.

• Infrastructure Development: India prides in constructing the highest number of US-FDA-compliant plants outside the US, indicating a robust infrastructure for pharmaceutical manufacturing. The countrys expertise in producing low-cost generic patented drugs and end-to-end manufacturing augments its position in the global pharmaceutical market. Indias strong domestic demand and strategic initiatives like the launch of the largest National Health Protection Scheme, underscore the Governments commitment to support and advance the pharmaceutical industry.

Trends and innovations

The Indian pharmaceutical company showcased remarkable resilience while navigating headwinds in the reported financial year. The industry underwent transformations amidst turmoil; however, it is expected to grow further to USD 120-130 billion over the next ten years. Continuous innovation and urge to meet the evolving demands will propel the growth of the Country.

• Adoption of Digital Technologies: Advanced digital technologies such as smart sensors, advanced analytics and automation are incorporated to enhance operational efficiencies. The adoption of digital solutions aims to streamline processes, improve product quality control and create a more agile and responsive industry framework.

• Enhancing Cybersecurity: With the increasing reliance on digital innovation, cybersecurity has become a primary requisite for the pharmaceutical sector in India. The companies rely on the integrity of sensitive data and maintenance of seamless operations to uphold the trust of their consumers, therefore, the rise in demand for a robust cybersecurity is observed to safeguard against potential cyber threats and breaches.

• Growing focus on sustainability- The conscious efforts to develop a sustainable future has emerged as a key trend in the pharmaceutical industry. The Indian pharmaceutical companies are adopting green manufacturing practices to reduce their carbon footprint and minimise environmental impact. The paradigm shift of embracing sustainable practices aligns with the evolving expectations of the consumers and regulatory requirements, driving the industry towards a more bright future.

Growth opportunities

• AI and Automation Advancements: The integration of AI and automation in drug discovery and manufacturing processes presents a lucrative opportunity for pharmaceutical firms to streamline operations, lower expenditure and expedite the development of novel treatments. Tools such as AlphaMissense and GNoME facilitate faster molecule design and property prediction, thus fostering the emergence of innovative materials and technologies.

• Flexible Manufacturing for Personalized Medicine:

Medical advancements in genomics and biomarker identification are fuelling the development of personalised medicines, customised to meet the requirement of the patients. Companies investing in flexible manufacturing technologies, such as modular manufacturing and single-use systems can capitalise on the growing demand for personalised drugs and adapt to changing formulations.

• Real-World Data Integration: The incorporation of real-world data into drug development processes streamlines safety evaluations, providing accurate analysis of a larger demographic and identification of minute details overlooked during clinical trials. The integration improves efficacy and facilitates the discovery of potential new treatments.

• Health Equity and Accessibility: The emphasis on health equity and develop accessibility presents the companies with opportunities to develop effective treatments accessible to an expansive demographic, addressing health disparities and affordability. The strategy aligns with the Companys increased demand to tap into unmarked clientele and understand the societal needs.

• Regulatory Changes and Data Transparency:

Governments and regulatory bodies globally are emphasising data transparency, quality assurance and traceability in the pharmaceutical supply chain. The shift presents opportunities for companies to leverage the potential of advanced technologies such as blockchain to ensure compliance, mitigate the risk of counterfeit drugs and foster collaboration among stakeholders. Consequently, an industry with integrity and increased reverence can be observed.

Challenges

1. Regulatory compliance and quality standards- Indian pharmaceutical companies are presented with the challenge of complying with international regulations and maintenance of high-quality standards. While developing innovative medications, it is imperative for the companies to allocate resources to ensure definite adherence to foreign jurisdictions, notably the United States. Conducting extensive research while adhering to evolving laws across different countries is a formidable obstacle. It is a challenge for industry participants to balance innovations with compliance. The Indian healthcare sector plays a vital role in guiding pharmaceutical companies by updating regulatory frameworks regularly.

2. Intellectual property rights (IPR)- The protection of intellectual property rights, particularly patents, is crucial for pharmaceutical companies. A significant investment is made in research and development to discover new drugs, patents serve as a deterrent against unauthorised copying of formulations. This allows companies to recoup their investments and generate profits. However, complexities arise ensuing access to affordable healthcare while safeguarding patents. Patent expirations and legal disputes can disrupt the dynamics of the pharmaceutical market. The industry is progressing towards developing mutually beneficial licensing agreements and streamlining operations to promote innovation while ensuring accessibility to essential medications.

3. Price controls and market dynamics- The imposition of monetary policies by the Indian government plays a crucial role in ensuring accessibility and affordability for all segments of society. However, these regulations impose challenges on pharmaceuticals as recuperating from investments made in research, development, and marketing becomes difficult. Despite enhancing accessibility to affordable medicines, stringent monetary policies negatively impact the pharmaceuticals profitability. To foster further the development of sustainable and equitable healthcare system, striking a balance between marketing freedom and affordability is essential.

4. Global supply chain disruption- The Indian pharmaceutical sector is reliant on imported raw materials and essential ingredients, making it vulnerable to global supply chain disruptions. Disturbance in the international supply chain can affect manufacturing processes and availability of medicines in India. Pharmaceutical companies must explore alternative local sourcing to mitigate global supply chain turmoil. The Government can devise initiatives to strategize consistent and reliable supply of medicines in the domestic market amidst global uncertainties.

5. Research and development- The Indian pharmaceutical sector faces significant challenges in conducting research and development (R&D) to develop new medicines. While India boasts a robust R&D infrastructure, there is a pressing need for increased funding in research and innovation initiatives. Developing novel and effective medicines necessitates substantial investment of time, resources and expertise.

Despite these factors posing a complex challenge for pharmaceutical companies, innovation still remains at forefront to stay ahead of competitors and augment medical progress. The Indian pharmaceutical industry remains committed to overcome these challenges and maintain its contribution in consolidating Indias position on the global medical map.

African Pharmaceutical Industry1

Africas pharmaceutical market presents a unique scenario with immense potential for growth. Historically, the continent has relied heavily on imports for medicine, with domestic manufacturing lagging behind. Almost 95% of the drugs consumed by the whole continent is imported while some Sub-Saharan countries rely entirely on imported medicines. Initiatives have been taken in Africa in recent years to rediscover the pharmaceutical sector and strengthen regulations around the same. The goal is to boost the continents self-reliance and tip the balance towards the middle.

Key Trends and Growth Opportunities:

• Shifting Market Focus: Stagnant growth in established markets is pushing pharmaceutical companies to explore new opportunities. Africas booming population and rising healthcare needs make it a prime target.

• Demographic Boom: Africas population is projected to double by 2050, creating a massive patient pool and increasing demand for medicines.

• Changing Disease Profile: Non-communicable diseases like cancer and diabetes are becoming the leading health concerns in Africa, necessitating new treatment options.

• Policy Push for Self-Sufficiency: The COVID-19 pandemic exposed Africas vulnerabilities in medicine production. Governments are now prioritising local manufacturing and sustainable markets.

• Public-Private Partnerships: Economically challenged countries are embracing public-private partnerships and creating business-friendly policies to attract investment.

• Regulatory Harmonization: Initiatives like the African Medicines Agency aim to streamline regulations across the continent, fostering a more unified market.

• Mobile Technology Integration: Mobile technology holds immense potential to improve diagnostics, data collection, and medicine distribution, addressing existing market inefficiencies.

Africa posing opportunities for India

• Limited domestic manufacturing: Africa relies heavily on imports for medicine, with weak local production of essential drugs and vaccines.

• Weak distribution networks: Inefficient distribution systems increase costs and allow counterfeit drugs to enter the market.

• Lack of universal healthcare: Many Africans cannot afford essential medicines due to the absence of universal healthcare coverage.

• Limited clinical research: Africas unique disease profile and genetic diversity are not well-reflected in clinical trials, hindering the development of relevant treatments.

• The brain drain of healthcare workers: African nations struggle to retain healthcare professionals due to better opportunities abroad.

Company overview

With a legacy spanning over three decades, Bliss GVS has established itself as a powerful pharmaceutical company. Founded in 1984, the Company prides in 40 years of expertise in manufacturing, marketing, and exporting over 250 branded formulations in various dosage forms. The Company has a global outreach, especially focusing on Sub- Saharan Africa. The Company enjoys a strong position in Africas anti-malarial market with its flagship brand, Lonart, which is WHO-endorsed.

Bliss GVS boasts of an extensive product portfolio, especially in the specialised market. The Company is considered as global leaders in Suppositories and Pessaries dosage forms. Bliss GVS facilities maintain European GMP standards and are accredited with EU GMP, US FDA, WHO GMP, OHSAS-18001:2007 and ISO-14001:2004, making it Indias first EU-GMP certified suppository maker.

Bliss GVSs relentless efforts to diversify their product portfolio has ushered the Company into a new domain of dermatology and herbal treatments. The Company is resolute to meet the evolving demands and exceed the expectations of their clients.

Human resource management

Bliss GVS Pharma Limited considers their workforce as one of their most valuable assets. The Company is committed to create a productive and holistic work environment, dedicated to provide a safe workplace for its employees. The Company includes a variety of skill development and engagement programmes to motivate its employees. Bliss GVS values their employees skills and provides necessary workshops to hone their skills to grow in their careers. The Company prioritises the health and safety of its employees by developing a comprehensive Environmental, Health and Safety (EHS) policy. Bliss GVS certified industrial hygiene practices are followed to ensure safety of the workers health and well-being.

Research and Development

Bliss GVSs Research & Development Centre religiously adheres to the regulations laid in the Good Laboratory Practices. The Company is equipped with the latest tools and pieces of equipment, such as particle size analyser, gas chromatography, high-performance liquid chromatography, dissolution testers, stability chambers and lab scale manufacturing equipment.

The Companys R&D team is certified by the Department of Scientific and Industrial Research (DSIR), Government of India. The team plays an important role in developing an innovation-driven culture throughout the organisation. Constituting proficient professionals in formulation and analytical development, the Company strives to innovate safe and effective medications that meet the evolving patients needs and regulatory requirements.

Quality assurance

Bliss GVS Pharma prioritizes patient safety and customer satisfaction by placing quality assurance at the forefront of everything they do. Their commitment is reflected in the certifications by various national and international regulatory authorities, including CDSCO (WHO GMP), US FDA, TGA, Health Canada, EU-GMP, ISO 9001, ISO 14001, ISO 22000, ISO 45001, and ANSI 455-4. These certifications are testaments to their dedication to maintaining the highest quality and safety standards throughout their operations.

Continuous improvement is ingrained in Bliss GVS Pharmas philosophy. They achieve this through a self-assessment framework encompassing Quality Risk Management, internal audits, and management reviews. A comprehensive Quality Management System (QMS) governs their processes, procedures, and responsibilities for achieving quality objectives. This system ensures quality is embedded in every aspect, from product development to distribution.

Quality Risk Management plays a vital role, allowing them to proactively identify, assess, and mitigate potential risks that could impact product quality and safety. By addressing these risks, Bliss GVS Pharma safeguards consumer health and maintains the integrity of its products.

The Company implements rigorous and extensive process control measures. This includes regular equipment calibration and qualification, process and system validation, adherence to operating procedures, and continuous process verification. They also leverage advanced analytical tools like chromatography, spectroscopy, and microbiological testing to assess the quality attributes of their products. These techniques enable them to accurately analyse raw materials and finished products, ensuring compliance with specifications and pharmacopeial requirements.

Regular internal and external audits are conducted to evaluate compliance with both regulatory requirements and internal quality standards. These audits provide valuable feedback for improvement and ensure the continued effectiveness of their quality systems.

Driven by feedback, data analysis, and innovation, Bliss GVS Pharma nurtures a culture of continuous improvement.

They actively seek opportunities to enhance their processes, technologies, and systems to deliver superior-quality products to their customers.

This dedication to excellence extends to their employees. Bliss GVS Pharma believes quality is a collective effort and encourages employee involvement through training, empowerment, and recognition programs. Finally, Bliss GVS Pharma invests in research and development, coupled with state-of-the-art manufacturing equipment. This ensures their products consistently meet the highest quality standards.

In conclusion, Bliss GVS Pharma upholds the most stringent quality standards throughout its operations. Their robust quality systems, advanced control tools, and continuous improvement initiatives all contribute to ensuring the safety, efficacy, and integrity of their products. This commitment to quality ultimately earns the trust and confidence of their customers and stakeholders.

Risk management

Risk	Explanation	Mitigation
Market volatility	The Companys sales and profitability can alter due to fluctuations in demand, pricing pressures, currency exchange rates and competitive dynamics. This can consequently shake the consumers trust in the Company.	Market volatility is something that each business has to face and the Company mitigates the risk by participating in extensive research and taking responsible measures for any changes.
Non compliance	Risks can be associated with the Companys inability to comply with laws, regulations and guidelines set by pharmaceutical regulatory authorities.	The Company is vigilant and understands compliance risks associated with the line of business. To maintain a strict adherence to all regulatory guidelines the Company has a team of experts dealing with the requirements in regular intervals.
Supply chain volatility	Transportation issues, geopolitical turmoil or supply disruptions can affect the timely delivery of raw materials, components or finalised products, resulting in production setbacks and scarcity of vital medications.	The Company mitigates these risks by diversifying suppliers and stockpiling critical materials to ensure a buffer against disruptions.

Financial Statement Standalone (in lakh)

Particulars	FY 2024	FY 2023	Y-O-Y (%)
Revenue	60,545.97	59,833.95	1%
EBITDA	10,716.87	9,015.52	19%
PBT before Exceptional Items	11,134.38	11,569.22	(4)%
PBT	7,025.77	11,569.22	(39)%
PAT	5,064.49	8,547.86	(41)%

Consolidated (in lakh)

Particulars	FY 2024	FY 2023	Y-O-Y (%)
Revenue	77,024.49	75,158.75	2%
PBT before Exceptional Items	14,606.81	10,607.16	38%
PBT	11,687.20	10,607.16	10%
PAT	8,157.79	7,673.48	6%
EBITDA	15,062.26	11,732.25	28%

 

Particulars	For the year ended March 31,2024	For the year ended March 31, 2023	Variance (%)	Reason for Variancefor more than 25%
Current Ratio	6.59	4.76	38%	Improvement due to decrease in current liabilities on account of reduction in capital creditors and lower utilisation of current borrowings
Debt-Equity Ratio	0.07	0.08	(17)%	-
Interest Coverage Ratio	23.50	12.94	82%	Improvement due to decrease in finance cost component
Debt Service Coverage Ratio	2.86	6.79	(58)%	Reduced due to increase in current maturities of long term debt
Return on Equity Ratio	0.05	0.10	(49)%	Due to decrease in profitability on account of one time exceptional item
Inventory Turnover Ratio	14.59	11.26	30%	Increase due to built up of stock to cater orders in hand
Trade Receivables turnover Ratio	1.52	1.47	3%	-
Trade Payable turnover Ratio	4.83	3.73	29%	Improvement due to reduction in creditors on account of timely payments
Net Working Capital turnover Ratio	1.24	1.21	2%	-
Operating Profit %	51%	47%	7%	-
Net Profit %	8%	13%	(40)%	Decrease due to one time exceptional item

Outlook

Bliss GVS Pharma is dedicated to uphold the highest standards in the pharmaceutical industry. Upon incorporating advanced technology and stringent operational practice, the Company has streamlined operations to meet the expectations of their consumers. Beyond simply complying with certifications like cGMP, the Company prioritises cultivating a culture of excellence and regulatory adherence across all aspects of its manufacturing teams. The Company incorporates quality into both products and processes, maintaining consistent integrity while pursuing cost- effectiveness through efficiency. The Company aims to continue progressing forward with renewed vigour, sustained by stable R&D investments and a robust manufacturing infrastructure. The Companys continued innovation and enhanced R&D capabilities aim to improve operational efficiency and diversify further into the global market.

Internal control systems and their adequacy

To ensure accurate recording of financial and operational information and compliance with various internal controls, statutory compliances and other regulatory compliances, the Company has a strong internal financial control system that is proportionate to the size, scale and complexity of its operations.

No significant or important observation regarding the effectiveness or appropriateness of such controls was made by the Companys internal auditors throughout the assessment period. The finance department closely monitors and assesses the effectiveness and sufficiency of the Companys internal control system, as well as its compliance with operational systems, accounting procedures and internal regulations at all of the Companys locations.

The effectiveness of the internal financial control system in the Company has been assessed and monitored by M/s. Kalyaniwalla & Mistry LLP, Chartered Accountants and Statutory Auditors of the Company. It complies with the Companys operating system, accounting practices and standards at all of its sites.

Corrective measures are performed in the relevant areas and controls are improved following the results of the Internal Audit functions report. The Audit Committee of the Board is given a presentation outlining any major audit observations, recommendations and recommended corrective action. In order to correctly manage the books of account and publish financial statements, the Company complies with all applicable Indian Accounting Standards.

Cautionary Statement

The Management Discussion and Analysis (MDA) section may contain forward-looking statements regarding potential future developments. These statements involve known and unknown risks and uncertainties that could materially affect final results. In addition to macro-environmental changes, a worldwide pandemic could introduce unforeseen, unprecedented and continuously evolving risks to the Company and its operating environment. The facts and figures in the report are derived from assumptions based on available internal and external data, making them susceptible to change as underlying variables are dynamic. Any forward-looking statement made in this context reflects the Companys current intentions, beliefs or assumptions as of the date it was made. The Company does not undertake to update or revise any forward-looking statements, whether due to new data, unexpected developments or other factors.