TOT BIOPHARM (1875. HK):Steadily Expanding CDMO Project

On August 7th, the Hang Seng Indexes Company Limited (HSIL) announced that biotech stocks have begun to show signs of improvement recently, benefiting from policy support and three consecutive months of capital inflows. With the introduction of more policies, the HS HK-listed Biotech Index has outperformed the market since July.

Obviously, the positive changes revealed in HSIL’s article provide investors with a new perspective, which may also indicate that the entire pharmaceutical sector is entering a new turning point.

Against the backdrop of the entire sector still being undervalued, pharmaceutical companies have marched into the financial reporting season these days, providing a window for the market to evaluate their value and predict future development.

TOT BIOPHARM COMPANY LIMITED (1875. HK) (hereafter referred to as TOT BIOPHARM), which submitted its interim report recently, has shown impressive business performance. So how should we view this report card of the company?

1. Financial Report Highlights: Significant Transformation Results to Achieve A Turnaround

The highlights revealed in the company's financial report can be summarized from the following aspects.

Firstly, there is strong revenue growth and impressive results in turning losses into profits.

In the first half of the year, TOT BIOPHARM reported operating revenue of 520 million yuan, a year-on-year increase of 59%, showing the strong growth momentum of the company's overall business. Among them, the growth in CDMO/CMO revenue is especially noteworthy, rising up to 144% year on year to 114 million yuan, and the product sales revenue reached 400 million yuan, a year-on-year increase of 44%, mainly by ongoing strong sales of core product Pusintin® (bevacizumab injection), demonstrating the solid foundation of the company's core business.

It is worth noting that the company achieved a turnaround from loss to profit during the period, with a net profit of 31.559 million yuan in the first half of the year. This transformation not only reflects the profitability of the company's business, but also enhances market confidence in its future development.

Secondly, there stands the company's excellent performance to generate revenue.

The company's ability to generate revenue continues to strengthen, and the net cash flow from operating activities continues to show a positive trend. The data shows that the net cash flow from operating activities of 27.801 million yuan in the first half of the year presents the company's excellent cash flow management and capital operation capabilities.

The core highlight of this report lies in the significant achievements of the company's strategic transformation.

This is directly reflected in the strong growth of CDMO/CMO business.

In the first half of the year, this business segment achieved a revenue of 114 million yuan, a year-on-year increase of 144%. It can be seen under the exponential growth that the company has successfully nurtured explosive growth points.

Secondly, the transformation fruits are also reflected in the significant increase in the company's CDMO projects and the certainty of future growth.

According to the financial report, the company added 20 new projects in the first half of the year, bringing the total to 115 projects. Among the new projects, 17 were ADC; In the meantime, 2 new pre-BLA (pre-biologics license application) projects have also been added, with a total of 8 in process. These projects will be directly linked to the commercial production of future products, providing the company with a clear path for performance growth and enormous commercial potential.

In addition, the company’s backlog reached184 million yuan, a year-on-year increase of 104%. This remarkable achievement not only proves the strong driving force of the company's business, but also provides a guarantee for the stable growth of its future revenue.

Besides, TOT BIOPHARM also features a firm determination and strategic vision for enterprise transformation in talent allocation and team building.

TOT BIOPHARM has realized rapid expansion of its professional talent team in the CDMO field, with its talent structure constantly being optimized. According to the financial report, the number of CDMO team members increased by 29% to 492 compared to the same period last year, accounting for 86% of the total number of employees in the group. Meanwhile, in its core niche of ADC CDMO, its team size has also reached a year-on-year increase of 27%. This series of data reflects the company's emphasis and investment in CDMO business.

Finally, the transformation achievements are also reflected in the continuous acceleration of the company's quality management system and multiple international recognition.

High standard of quality management ensures the high standards and quality of the company’s products and services. Its quality management system can meet the GMP standards of China, the United States, and Europe, and has been widely recognized by the domestic and foreign industries, which provides pass for its products and services to enter the international market, facilitating the company’s global expansion.

Furthermore, high-frequency GMP audits undergone further manifest the stability and reliability of the company’s quality management system. According to the data, as of June 30, 2024, the Group underwent more than 60 GMP audits cumulatively. This included passing the EU QP audit with zero defects on the first attempt, passing the official GMP audit directly on-site in Colombia, and passing the GMP audits in Indonesia, Egypt and other countries. Furthermore, the Group assisted its customers in completing inspections by their overseas partnering MNC pharmaceutical companies and other institution on multiple occasions, and successfully collaborated with its customers in completing the licensing with high recognition.

In the fiercely competitive pharmaceutical market, quality is the key to standing out for enterprises. TOT BIOPHARM continuously improves its quality management system, and its achievements fully demonstrate the company's outstanding performance in quality management, which will help the company attract more investment and cooperation opportunities, and thus promote further business development.

Overall, TOT BIOPHARM's financial report reveals the company's highlights in multiple aspects. These highlights not only demonstrate the company's current business strength, but also provide solid support for the company's future sustainable development and market competitiveness.

1. Confidence to Rally from 3 Bottoms Ahead of the Industry?

The valuation of the pharma industry is often affected by compounding factors in the capital market, and the industry is facing a multitude of challenging trends formed by three bottoms: policy bottom, fundamental bottom, and sentiment bottom.

From a policy bottom perspective, the government continues to increase policy support for the pharma industry, providing a stable external environment and development opportunities for the industry.

Since the beginning of this year, many regions have issued intensive policies to support pharmaceutical innovation to promote the high-quality development of innovative drugs in an all-round way. And just before this, on July 30th, Shanghai also issued the "Several Opinions on Supporting the Innovative Development of the Whole Chain of the Biomedical Industry", which triggered a heated response in the market. The policy support for innovative drugs will obviously bring new opportunities to the CXO industry, which is known as the "water seller" of innovative drugs.

In terms of fundamental bottom, the entire pharma industry has shown weak performance in recent years. Nowadays, with the optimization of industry structure and the improvement of innovation capabilities, the fundamentals of the pharmaceutical sector are gradually improving, and those directions with sustainable profitability are becoming the focus of capital allocation.

As regards sentiment bottom, after a long period of sluggish environment, the market is gradually recovering confidence in the pharmaceutical sector, and the recovery of investor sentiment will inject momentum for the valuation repair of the sector.

In this context, as an pharmaceutical company, TOT BIOPHARM shows unique advantages in the industry, especially the series of gratifying changes in its fundamentals accompanying the transformation, enabling the company's value growth to be re-examined by the market.

Since it shifted to biopharmaceutical CDMO in an all-round manner in 2020, the company has established new growth points from series of actions to layout in the CDMO field. This has withstood continuous verification.

Looking ahead, with the increasing demand for global pharma R&D outsourcing services under the industry background, TOT BIOPHARM is expected to further expand its market share in the CDMO business and builds a strong engine for climbing new highs in revenue. Moreover, the company has successfully collaborated with its customers in completing the licensing multiple times, laying a solid foundation for the company's expansion into international markets.

Focusing on biopharmaceuticals and emerging from the ADC field, TOT BIOPHARM has established a high-level domestic commercial production line that integrates antibodies, ADC substance, and drug products, and continues to build a cutting-edge ADC CDMO technology platform, representing the company's professional capabilities and technical strength in the field of biopharmaceuticals, especially ADC. Regarding the high technical barriers in the research and production of ADC drugs, TOT BIOPHARM has established a competitive advantage in the field of ADC CDMO with its high standard production line and technology platform, consolidating the company's market position in biopharmaceutical CDMO.

Biologics, a well deserved hot field nowadays, contains broad prospects in the ADC market. According to Frost&Sullivan, the global ADC market is expected to grow at a high compound annual growth rate of 30.0% from $7.9 billion in 2022 to $64.7 billion in 2030. The rapid development of the ADC track will also provide broad incremental space for the ADC CDMO business market. TOT BIOPHARM, a pharma company with a deep layout in it, will undoubtedly continue to benefit.

In summary, the combination of the three bottoms has brought opportunities for the pharma industry to navigate challenges, while TOT BIOPHARM, with its core competitiveness in the industry and comprehensive advantages in track layout, holds the potential to rally ahead of the entire industry. With the improvement of the market environment and the enhancement of the company's own strength, TOT BIOPHARM is expected to achieve both excellent performance and good valuation.

3. Conclusion

Through in-depth analysis of the company and its pharmaceutical sector, TOT BIOPHARM's development potential and future prospects can be clearly seen in the current market environment.

The core competitiveness of TOT BIOPHARM, especially its active layout in the biopharmaceutical CDMO business, indicates that the company will occupy a more important position in the future pharmaceutical market.

It is believed that TOT BIOPHARM's subsequent market performance will also be worth waiting with the continuous growth of performance and the improvement of market recognition.