Company: RPID
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0001380106-25-000058
Chunk: 35

Company: RAPID MICRO BIOSYSTEMS, INC.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 35
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 the MQC testing market with alternative automated solutions, such as Interscience, which offers a partially-automated system for MQC testing, and Clever Culture Systems, which offers an environmental monitoring product focused on the pharmaceutical microbiology market. There are also several established companies in the bioprocessing technology market with whom we do not currently compete, but that could develop products that will compete with us in the future. 

Many of the established companies have substantially greater financial and other resources than us, including larger research and development teams or more established marketing and sales and commercial teams. Smaller or early-stage companies may also prove to be significant competitors, particularly if they establish collaborative arrangements with large companies. These competitors also compete with us in recruiting and retaining qualified engineering, sales, marketing and management personnel, as well as in acquiring technologies complementary to, or necessary for, our programs.

Seasonality

Our revenues vary from quarter to quarter as a result of factors such as our customers’ budgetary cycles and extended summer vacation periods that can impact our ability to deliver products and provide onsite services to our customers during those periods. We expect this volatility to continue for the foreseeable future, which may cause fluctuations in our operating results and financial metrics.

Government regulation

We provide products and services used for quality-control testing in pharmaceutical product and medical device manufacturing. Although our Growth Direct platform is not directly subject to regulation by the FDA, our customers’ products and product candidates are subject to extensive regulation by the FDA and other federal and state authorities in the United States, as well as comparable authorities in foreign jurisdictions. In the United States, many of our customers’ products are regulated as either medical devices or drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and its implementing regulations, or as biological products under the FDCA and the Public Health Service Act, or the PHSA, and their implementing regulations, each as amended and enforced by the FDA. The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage, 

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installation, servicing, recordkeeping, premarket clearance or approval, adverse event reporting, advertising, promotion, marketing and distribution, and import and export of medical devices, drugs and biological products to ensure that such products distributed domestically are safe and effective for their intended uses and otherwise meet the applicable requirements of the FDCA and the PHSA. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or