Windlas Biotech Ltd IPO

Some of the competitive strengths are as follows

Innovative portfolio of complex generic products supported by robust R&D capabilities:
Windlas Biotech is focused on developing and launching new complex generic products, particularly those related to the formulation manufacturing process and drug delivery. The manufacturing of complex generics provides for higher profitability owing to limited competition with presence of only a few players. The R&D and innovation capabilities focus on (i) creating novel formulations of existing molecules aimed towards improving patients benefit through reduction of ‘pill burden’ or improvement of organoleptic features of the product; (ii) launching low cost ‘first-tolaunch’ generic products in the market, i.e., launching immediately after the patent expiry of products, and (iii) creating new delivery mechanism of an approved drug. 

Long-term relationships with Indian pharmaceutical companies:
Windlas Biotech has developed relationships with leading Indian pharmaceutical companies, including Pfizer Limited, Sanofi India Limited, Cadila Healthcare Limited/ Zydus Healthcare Limited, Emcure Pharmaceuticals Limited, Eris Lifesciences Limited, Intas Pharmaceuticals Limited and Systopic Laboratories Private Limited. The company’s operational track record in successful delivery of products, responsiveness, dosage innovation, complex generic product development, quality and technical standards, turnaround times, and productivity has facilitated the strengthening of their customer base and helped them in expanding their product and service offerings as well as geographic reach. The CDMO agreements with the customers are typically long-term in nature where the validity of the contract ranges between two to five years, with the option of renewal on mutually agreed terms. These long-term agreements allow them to plan their capital expenditure and enhance their ability to benefit from increasing economies of scale.

Efficient and quality compliant manufacturing facilities with significant entry barriers:
Windlas Biotech continuously aim to improve cost-efficiencies and increase productivity in their operations through use of automation in process equipment as well as use of software in capacity and resource planning and minimization of waste. The company has also made significant investments in quality management systems and have moved from a ‘paper-based’ approach to ‘electronic-based’ systems in manufacturing and quality controls as well as validation activities which enables them to undertake data analytics and track product level information across the different facilities and teams. Also, developing the expertise to comply with stringent regulatory audits and validation requirements has been a challenge for both pharmaceutical companies and CDMOs, and has been seen as a significant barrier to entry for many CDMOs, as facilities can take years to construct and properly validate.

Risk Factors:

Some of the risk factors are as follows

1.    The company is dependent on the success of their relationships with their CDMO customers. Any adverse developments or inability to enter into or maintain such relationships could have an adverse effect on their business. 

2.   The company is subject to strict technical specifications, quality requirements, regular inspections and audits by their CDMO customers. Failure to comply with the quality standards and technical specifications prescribed by such customers may lead to loss of business from such customers and could negatively impact their reputation and business prospects.

3.    Manufacture of injectables will be a new business for the Company and if they are unable to establish themselves in this business segment, their results of operations and cash flows may be adversely affected.