UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): January 16, 2025
(Exact name of registrant as specified in its charter)
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Not Applicable
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
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The | ||||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company þ
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 7.01 | Regulation FD Disclosure. | ||||
On January 16, 2025, Rapid Micro Biosystems, Inc. updated its corporate presentation for use in meetings with investors, analysts and others. The presentation is available through the Investor Relations section of its website and a copy of the presentation is furnished as Exhibit 99.1 to this report.
The information furnished under this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as otherwise expressly stated in such filing.
Item 9.01 | Financial Statements and Exhibits. | ||||
(d)Exhibits.
| Exhibit No. | Description | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| RAPID MICRO BIOSYSTEMS, INC. | ||||||||
| Date: January 16, 2025 | By: | /s/ Sean Wirtjes | ||||||
| Sean Wirtjes | ||||||||
| Chief Financial Officer | ||||||||
Rapid Micro Biosystems 43rd Annual J.P. Morgan Healthcare Conference Rob Spignesi, President & CEO January 16, 2025 R A P I D M I C R O B I O S Y S T E M S N A S D A Q : R P I D © 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc.
Rapid Micro Biosystems Disclaimers 2 This presentation has been prepared by Rapid Micro Biosystems, Inc. (the “Company”) solely for informational purposes. This presentation includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the Company’s guidance, including with respect to the fourth fiscal quarter and full year 2024; the benefits and features of the Company's products and technology, including its Growth Direct platform and rapid sterility offering; the integration of the Company's Growth Direct technology with Lonza's MODA-EM software system; the Company's goal to achieve positive cash flow by the end of 2027 without additional financing, including the revenue and gross margin drivers behind such goal; and the Company's efforts to drive sustainable, long-term growth and shareholder value. In some cases, you can identify forward-looking statements by terminology such as “outlook,” “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements involve known and unknown risks, uncertainties and assumptions which may cause actual results to differ materially from any results expressed or implied by any forward-looking statement, including, but not limited to risks related to, the Company's ability to achieve positive cash flow without requiring additional financing; the Company's ability to achieve its business objectives; the Company's significant losses since inception; the Company’s ability to meet its publicly announced guidance and other expectations about its business and operations; the effectiveness of the Company's sales processes; the Company’s need to develop new products and adapt to technological changes; the Company’s ability to establish and maintain its position as a leading provider of automated microbial quality control testing; the Company’s ability to maintain its manufacturing capabilities; the Company's ability to improve the gross margins of its products and services; risks related to third-parties; the Company’s ability to retain key management and other employees; risks related to regulatory and intellectual property matters; risks related to supply chain disruptions and the impact of inflation; the impact of macroeconomic volatility; and the other important factors outlined under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in its other filings with the SEC, which are available on the SEC's website at www.sec.gov and the Investor Relations page of its website at investors.rapidmicrobio.com. Although the Company believes that the expectations reflected in its forward-looking statements are reasonable, it cannot guarantee future results. The Company has no obligation, and does not undertake any obligation, to update or revise any forward-looking statement made in this presentation to reflect changes since the date of this presentation, except as may be required by law. The Company has presented preliminary financial results for the fourth fiscal quarter and full year 2024 that have not been audited and are subject to adjustment based on the Company’s completion of year-end financial close processes. © 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc.
Rapid Micro Biosystems C Our vision We are transforming a critical, regulated part of the global pharmaceutical manufacturing process, bringing microbial quality control into the 21st century. The new standard in microbial quality control 3© 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc.
Rapid Micro Biosystems The standard in automating microbial quality control 4 ~25% Year / Year Growth ~$28M Total Revenue 2 0 2 4 R E V E N U E 1 G L O B AL S Y S T E M S 1 C U S T O M E R S ~$15M Recurring Revenue 135+ Cumulative Validations 160+ Cumulative Placements ~20 Countries 100% Approved CAR-T Manufacturers 70% Top 20 Global Pharma2 1 Preliminary and Unaudited for the year ended December 31, 2024 2 By revenue © 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc.
Rapid Micro Biosystems Record quarterly (Q4) and full year revenue; ninth quarter in a row exceeding / meeting revenue guidance Over 160 cumulative Growth Direct systems now placed globally Inflected to positive gross margins in Q3 & Q4 Announced collaboration with Lonza implementing Growth Direct globally to enable end-to-end automation of MQC testing across cell & gene manufacturing network 2024 revenue guidance exceeded with strong fourth quarter 5 RE S ULTS Q 4 2 0 2 4 1 FY 2 0 2 4 1 Total Revenue ~$8.2M ~30% growth ~$28.1M ~25% growth Recurring Revenue ~$4.2M ~$15.5M Systems Placed 6 21 Systems Validated 4 16 © 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc. S E L E C T H I G H L I G H T S 1 Preliminary and Unaudited for the year ended December 31, 2024
Rapid Micro Biosystems Insecure and lacking data integrity High volume testing and mandated by regulators Manual, paper-based and slow Subjective and prone to human error 6 Challenges in a traditional microbial quality control (MQC) lab © 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc.
Rapid Micro Biosystems Scientific and technology innovation Growing demand for more complex therapies Faster & leaner manufacturing Data integrity & security focus Regulatory scrutiny + F A C T O R S D R I V I N G C H A N G E Discovery & research QC & ANALYSIS Bioprocessing & manufacturing T O D A YT O D A Y T O D A Y Flexible single use technologiesHigh-throughput R&D automation MQC has not kept up with pharma industry innovation + + + 7© 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc.
Rapid Micro Biosystems THE GROWTH DIRECT® (GD) PLATFORM The only fully automated, high-throughput and secure MQC solution… Proprietary Consumables Data & Software Global Validation & Support Services …delivering a compelling value proposition Data Integrity Supports global quality regulatory compliance and improved data handling and management Operational Efficiency Enables faster decision making by accelerating time to results by 50% or faster compared to the traditional method Insight & Accuracy Eliminate human quality control errors, preventing costly recalls and regulatory interventions 8 Introducing the Growth Direct® platform © 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc.
Rapid Micro Biosystems P ULL QC T E S T FORM 1. FILL OUT A S S A Y INFO 2. P RE P A RE S A MP LE S 3. LOA D INCUB A T OR 4. P ULL S A MP LE S 5. P E RFORM COUNT S 6. RE CORD COUNT S 7. RE T URN S A MP LE S 8. S HIFT S A MP LE S 9. P ULL S A MP LE S 10. P E R FOR M C OU N T S 11. DIS CA RD 15. K E Y INT O L IMS 14. P E RFORM DUA L-RE A D 12. RE CORD COUNT S 13. RE S ULT S Prepare sample & automated loading 1 Automated incubation and analysis & Data handling 2 Results Manual & subject to error 15 steps 5-14 days to result / test Unsecured Automated & accurate 2 steps Results in half the time Full data integrity 9 Growth Direct® transforms and modernizes MQC M A N U A L W O R K F L O W G R O W T H D I R E C T ® A U T O M A T E D W O R K F L O W © 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc.
Rapid Micro Biosystems The Growth Direct® System brings MQC into the 21st Century Discovery & research QC & ANALYSIS Bioprocessing & manufacturing T O D A YT O D A Y T O D A Y 10 Scientific and technology innovation Growing demand for more complex therapies Faster & leaner manufacturing Data integrity & security focus Regulatory scrutiny + F A C T O R S D R I V I N G C H A N G E + + + © 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc. Flexible single use technologiesHigh-throughput R&D automation
Rapid Micro Biosystems Market forces pushing pharma industry to automation 11 Regulatory Pressure Increasing regulatory scrutiny and enforcement around data integrity and quality Industry Change Growth in complex biologics, and cell & gene therapies which require faster, more accurate, higher throughput testing capabilities Large and Growing Market $5B annual recurring revenue + $5B global system opportunity Sources: FDA, EvaluatePharma, Alliance for Regen. Medicine © 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc.
Rapid Micro Biosystems Growth strategy focused on land and expand augmented by innovation 12 PU R SU E AD J A C E N T M AR K ET S D R I VE EN T ER PR I SE D EPL O Y M EN T S EXP AN D I N T O N EW G EO G R AP H I E S L AU N C H N EW PR O D U C T S AN D SER VI C E S G R O W N EW C U ST O M ER AD O PT I O N BIO PHARMA ( inc l . ce l l & gene) CDMO STERILE INJECTABLE, VACCINE, & OTHER LAND AND EXPAND STRATEGY Sample automation Additional test types (e.g. sterility) Data services and SaaS Automated microbial ID Core Growth Direct Capabilities EM + W/BB + Sterility + EM + W/BB + Sterility + EM + W/BB + Sterility + Site 1 Site 2 Site 3+ © 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc.
Rapid Micro Biosystems 13 C U S T O M E R S E G M E N T S W I T H E S T A B L I S H E D U S E G L O B A L S I T E S W I T H G R O W T H D I R E C T S Y S T E M S of approved CAR-T manufacturers have GD system placed 100% cumulative systems validated 135+ cumulative consumables sold 6M+ customer manufacturing sites ~100 cumulative systems placed 160+ of top 20 global pharma are customers 70% G R O WTH D I R E C T AP P L I C AT I ON S Environmental Monitoring Water Testing Bioburden Testing Rapid Sterility Testing Biologics Small Molecules CDMO Personal Care Products Cell & Gene Therapy / CAR-T Customer base includes 70% of the top 20 global pharma companies1 with significant growth potential © 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc. 1 By revenue
Rapid Micro Biosystems Collaborating in automated MQC 14 • Lonza sought an end-to-end, automated solution to streamline MQC testing and get critical cell and gene therapies to patients faster • Implemented the Growth Direct with Lonza’s MODA-EM software module across their cell and gene therapy manufacturing network in North America, Europe and Asia • Lonza achieved: ▪ More accurate testing ▪ Faster processing (TTR <72 hrs vs up to 8 days previously) ▪ Improved compliance ▪ Cost savings • Sets a clear standard for the industry to emulate • Lonza publication available on RPID website © 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc. www.rapidmicrobio.com/learning-center/publications
Rapid Micro Biosystems Rapid Sterility System Growth through innovation: R AP I D S T E R I L I T Y S Y S T E M C O M P E N D I AL M E T H O D Time to Results (TTR) As little as 1 - 3 Days 14 Days As little as 12 hours Time to Detection (TTD) 3 – 5 Days 15 Growth Direct® Rapid Sterility System © 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc.
Rapid Micro Biosystems 2022 2023 2024e $17.1M ~$28.0M1 $22.5M Strong and consistent revenue growth and margin improvement 16 +30% R E V E N U E G R O S S M A R G I N Revenue Growth Drivers • New customer wins • Drive global deployments at existing customers • Launch new products and services • Strong consumable and service growth Gross Margin Expansion Drivers • Reduce product costs • Improve manufacturing efficiency • Increase service productivity 2022 2023 2024e1 Recurring Non-recurring Focused goal of achieving positive cash flow by the end of 2027 without the need for additional financing 50+ percentage point improvement © 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc. 1 Preliminary and Unaudited for the year ended December 31, 2024
Rapid Micro Biosystems 17 Growth Direct® is the industry-leading platform Chosen by 70% of the top 20 global pharma companies1 with significant commercial runway Operating behind strong barriers to entry First mover advantage, little competition & robust patent portfolio Enabling advanced pharmaceutical manufacturing Growth Direct systems placed with 100% of approved CAR-T manufacturers An expanding $10B+ market Dominated by manual, legacy processes that face increasing FDA scrutiny Attractive, high-growth business model Driving high-yield recurring revenue Creating the future of rapid, secure MQC automation to drive sustainable, long-term growth and shareholder value 1 By revenue © 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc.
Rapid Micro Biosystems Thank you © 2025, Rapid Micro Biosystems, Inc. | RAPID MICRO BIOSYSTEMS® and GROWTH DIRECT® are registered trademarks of Rapid Micro Biosystems, Inc., and the company logo is a trademark of Rapid Micro Biosystems, Inc.