Company: RPID
Filing Date: 2025-11-07
Form Type: 10-Q
Source: 0001380106-25-000200
Chunk: 264

Company: RAPID MICRO BIOSYSTEMS, INC.
Filing Date: 2025-11-07
Form: 10-Q
Item: Part II, Item 1A
Chunk 264
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, manual method of MQC testing and other automated technologies and is perceived by customers to be cost effective;

•the continued growth of the pharmaceutical and biopharmaceutical industry, in particular biologics and cell and gene therapies;

•our ability to execute on our business strategy, including continuing to expand in the market for cell and gene therapies;

•the rate of adoption of our platform and solutions by drug manufacturers;

•prices we charge for our systems and consumables;

•the relative reliability and robustness of our platform as a whole and the components of our platform;

•our ability to develop new products for existing customers and to expand our capabilities within the MQC testing workflow;

•our ability to expand the use of our platform with existing customers;

•other competitive automated MQC testing platforms; and

•the impact of our investments in product innovation and commercial growth.

We cannot assure our stockholders that we will be successful in addressing each of these criteria or other criteria that might affect the market acceptance of our products. If we are unsuccessful in achieving and maintaining commercial market acceptance of our Growth Direct platform, our business, financial condition, results of operations and prospects could be adversely affected.

Our operating results have fluctuated significantly in the past and will fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations.

Our quarterly and annual operating results have fluctuated significantly in the past and may fluctuate significantly in the future, which makes it difficult for us to predict our future operating results. For example, we have experienced positive trends in our gross margins, improving from (5)%  to 6% for the nine months ended September 30, 2024 and September 30, 2025, respectively. Expansion in gross margins in future periods may not be linear and may be subject to 

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variability from period to period. Additionally, revenue growth and operating expenses may also be subject to variability from period to period. For example, we recently raised guidance with respect to Growth Direct system placements and total revenue for the full year ending December 31, 2025, together with the receipt of a large, multi-system customer order that we expect to contribute to our fourth quarter and full year 2025 results. If fulfilled in the contemplated timeframe, these system sales would be expected to contribute meaningfully to Growth Direct system revenue and placements in the fourth quarter. However, there can be no assurance that we will meet our guidance or achieve placement of the ordered