Company: RPID
Filing Date: 2025-11-07
Form Type: 10-Q
Source: 0001380106-25-000200
Chunk: 263

Company: RAPID MICRO BIOSYSTEMS, INC.
Filing Date: 2025-11-07
Form: 10-Q
Item: Part II, Item 1A
Chunk 263
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, including with respect to revenue and gross margins, which may not be replicated in future periods. Our cash flow goal also depends on our ability to realize additional cost savings that we believe are reasonably achievable, but are not guaranteed. We will need to generate significant additional revenue, significantly improve our gross margin and/or further reduce costs to achieve positive cash flow and profitability, and even if achieved, we cannot be sure that we will sustain positive cash flow and profitability for any substantial period of time. While our goal to achieve positive cash flow is underpinned by our recent and historical performance, such performance is not necessarily indicative of our future results.

Our limited operating history makes it difficult to evaluate our future prospects and the risks and challenges we may encounter.

We launched our current second-generation Growth Direct platform in 2017 for which we are continuing to grow our manufacturing and sales and marketing capabilities. Consequently, predictions about our future success or viability may not be as accurate as they could be if our products had a longer commercial history. While our product and services revenue has continued to increase in recent periods, if our strategy to grow and scale our business is not successful, we may not be able to achieve continued revenue growth. Our limited operating history, evolving business and rapid growth make it difficult to evaluate our future prospects and the risks and challenges we may encounter, and we may not continue to grow at or near historical rates.

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In addition, as we seek to innovate in and disrupt the current microbial quality control ("MQC") market, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown challenges. We are transitioning to a company capable of supporting commercial manufacturing, sales and marketing at scale in the United States and abroad. We may not be successful in such a transition and, as a result, our business may be adversely affected.

Our business depends on the commercial success of our Growth Direct platform, which may not be achieved or maintained.

Our business is dependent on sales of our Growth Direct systems and related consumables and services. Our ability to achieve and maintain commercial market acceptance of our Growth Direct platform will depend on a number of factors, including:

•significant acceptance by drug manufacturers of automated MQC testing;

•our ability to increase awareness of the capabilities of automated MQC testing and our technology and solutions;

•our customers’ willingness to adopt new technologies and workflows;

•our ability to integrate our platform with our customers’ existing workflows, including related to regulatory validation processes;

•whether our platform reliably provides advantages over the conventional