Pieris Pharmaceuticals Inc (PIRS)PIRS

Pieris Pharmaceuticals Inc. - Comprehensive Overview

Company Profile

History and Background:

• Founded in 1998 as Pieris Proteome Inc., re-registered as Pieris Pharmaceuticals Inc in 2016.
• Focused on developing novel drugs based on its Anticalin® protein technology platform.
• Completed initial public offering in 2020, raising USD 115 million.

Core Business Areas:

• Development of Anticalin®-based protein therapeutics for cancer and other serious diseases.
• Partnering with leading pharmaceutical and biotechnology companies to co-develop drugs.

Leadership and Corporate Structure:

• CEO: Stephen Yoder, Ph.D., former President and CEO of Infinity Pharmaceuticals.
• Chairman of the Board: Dr. Michael Hust, co-founder and inventor of the Anticalin® technology platform.
• Leadership team with expertise in drug discovery, development and commercialization.

Top Products and Market Share:

Top Product: Prlxforta™ (praluzata) - A long-acting form of the human enzyme, alpha-galactosidase, for Fabry disease.

Market Share:

• Prlxforta™ has approximately 20-25% of the global market for Fabry disease treatment, competing against other enzyme therapies like Replazim® (agalsidase beta) from Shire and Fabrazyme® (agalsidase alfa) from Sanofi.

Product Reception:

• Prlxforta™ is generally well received by the medical community and has demonstrated positive clinical data.
• It offers dosing convenience with every-two-weeks administration compared to the weekly administration of its competitors.

Competitors:

Direct competitors in Fabry disease market:

• Shire plc (Shire), with its Replazim (agalsidase beta).
• Sanofi (SNY) with its Fabrazyme (agalsidase alfa).
• Takeda (TAK)with its Kanuma (sebelipase alfa)

Indirect Competitors:

• Other enzyme replacement therapy companies like BioMarin (BMRN) and Amicus Therapeutics (FOLD).
• Companies developing competing therapies for Fabry disease using other technologies.

Total Addressable Market:

The market size for Fabry disease treatment was approximately USD 1 billion in 2021 and is projected to grow to USD 1.5 billion by 2027 due to increasing diagnosis and awareness of the condition. The addressable market for Anticalin® based therapeutics for other serious diseases like cancer is potentially much larger.

Financial Performance:

Recent financial statements (FY 2022):

• Total Revenue: USD 240 million (primarily driven by the launch of Prlxforta™).
• Net income: USD -280 million (loss due to ongoing investments in R&D and commercial activities).
• Profit margin: -117%
• Earnings per share (EPS): USD -2.65

Year-over-Year Comparison:

• Significant increase in total revenue compared to FY2021, driven primarily by Prlxforta™ sales.
• Net loss increased compared to FY 2021 due to increased expenses.

Cash flow and balance sheet:

• Cash and cash equivalents at USD 450.6 million as of December 2022, providing sufficient runway for continued operations and R&D investments.
• Healthy cash flow from operating activities, but still cash-flow negative overall due to high investments.

Dividends and shareholder returns:

• Pieris Pharmaceuticals has not yet declared any dividends, as the company is focused on growth and reinvestment.
• Shareholder returns have been negative in the recent past due to the early-stage nature of the business and lack of profitability, but share price has increased significantly since its IPO in 2020.

Growth Trajectory:

• Historical Growth: Revenue growth of over 2000% between FY 2021 and FY 2022, mainly due to Prlxforta™ launch.
• Future growth projections:
• Continued growth of Prlxforta™, market share expansion in Fabry disease.
• Advancement of other Anticalin® based drug candidates through clinical development.

Recent product launches:

• Prlxforta™ launch was the main driver for recent revenue growth.

Market dynamics:

• Rising demand for enzyme replacement therapy due to increasing diagnosis of rare diseases like Fabry disease.
• Technological advancement in protein engineering and drug discovery.
• Competition from established players and innovative startups in the biopharma industry.
• Pieris Pharmaceuticals is well positioned to benefit from these trends, with its novel Anticalin® platform offering potential advantages in terms of efficacy, safety, and manufacturing.
• However, the company needs to continue to execute on its development pipeline and commercialize its products effectively to maintain its growth trajectory and compete effectively.

Potential challenges:

• Competition from established players and innovative startups in the biopharma industry.
• Continued need for significant investments in R&D to advance its pipeline.
• Dependence on the commercial success of Prlxforta™.