RGEN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-10-30

• On October 6, 2026, we completed our previously announced acquisition of BioLife Solutions, Inc. (“BioLife”), a company focused on developing cell processing tools and services for the cell and gene therapy market, for approximately $1.9 billion, comprised of approximately 7.2 million shares in our …

• Three Months Ended September 30,Nine Months Ended September 30,

• During the three and nine months ended September 30, 2026, product revenue increased by $20.5 million, or 10.9%, and $67.3 million, or 12.5%, respectively, as compared to the same period in 2025. This growth is widespread across our portfolio of products and includes contributions from all our franc…

• During the three months ended September 30, 2026, product revenue increased 27.9% in Europe and 6.3% in North America, and decreased 3.2% in Asia Pacific and the rest of the world. During the nine months ended September 30, 2026, product revenue increased 19.6% in Asia Pacific and the rest of the wo…

• Three Months Ended September 30,Nine Months Ended September 30,

Text removed vs the prior filing · source: 10-Q · 2026-07-29

• On July 21, 2026, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) to acquire all of the outstanding shares of common stock of BioLife Solutions, Inc. (“BioLife”), a publicly traded company focused on developing cell processing tools and services for the cell and gene therapy…

• At the closing of the Transaction, BioLife stockholders will be entitled to $11.25 in cash per share plus 0.1442 shares of Repligen common stock per BioLife share. The Transaction is subject to customary closing conditions, including (among others) (i) the adoption and approval of the Merger Agreeme…

• During the three and six months ended June 30, 2026, product revenue increased by $21.8 million, or 11.9%, and $46.8 million, or 13.3%, respectively, as compared to the same period in 2025. This growth is widespread across our portfolio of products and includes contributions from all our franchises.

• During the three months ended June 30, 2026, product revenue increased 43.3% in Asia Pacific and the rest of the world and 17.3% in North America, and decreased 6.1% in Europe. During the six months ended June 30, 2026, product revenue increased 36.1% in Asia Pacific and the rest of the world, 11.2%…

• Royalty and other revenues in the three and six months ended June 30, 2026 and 2025 relate to royalties received from a third-party systems manufacturer associated with our OPUS® chromatography columns. Royalty revenues are variable and are dependent on sales generated by our partners.

Text added vs the prior filing · source: 10-Q · 2026-10-30

• result, automated and business process controls that rely on information from the systems were also deemed ineffective because they could have been adversely affected.

• •Irrespective of the effects of the IT general controls deficiencies, management did not perform certain business process-level controls related to inventory valuation and the financial statement close process either in a timely manner or with an appropriate precision threshold.

• As of September 30, 2026, the Company has not remediated these material weaknesses. In connection with the remediation plan previously disclosed in the Form 10-K, the Company performed remediation activities during the nine months ended September 30, 2026, as detailed below.

• IT General Controls - During the nine months ended September 30, 2026, our remediation activities included the following with respect to IT general controls:

• •Continued execution of controls that we worked to improve during fiscal year 2025 that did not have a sufficient period of time to demonstrate operating effectiveness as of December 31, 2025;

Text removed vs the prior filing · source: 10-Q · 2026-07-29

• 26, 2026 (“Form 10-K”). Notwithstanding the material weaknesses, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that the unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q are fairly stated in all material respects i…

• Irrespective of the effects of the IT general controls deficiencies, management did not perform certain business process-level controls related to inventory valuation and the financial statement close process either in a timely manner or with an appropriate precision threshold.

• As of June 30, 2026, the Company has not remediated these material weaknesses. In connection with the remediation plan previously disclosed in the Form 10-K, the Company performed remediation activities during the six months ended June 30, 2026 as detailed below.

• IT General Controls - During the six months ended June 30, 2026, our remediation activities included the following with respect to IT general controls:

• Continued execution of controls that we worked to improve during fiscal year 2025 that did not have a sufficient period of time to demonstrate operating effectiveness as of December 31, 2025;

Text added vs the prior filing · source: 10-Q · 2026-10-30

• adverse effect on our business, financial condition or results of operations, nor are we aware of any governmental proceedings involving potential monetary sanctions of $0.3 million or more.

Text added vs the prior filing · source: 10-Q · 2026-10-30

• We may be unable to successfully and efficiently integrate BioLife’s business into the Repligen enterprise, which could adversely affect our business, financial condition and results of operations.

• Our ability to realize the anticipated benefits of the acquisition of BioLife depends on the successful and efficient integration of BioLife’s business into our existing business. The integration process may require significant management attention and resources and could result in unforeseen diffic…

Text removed vs the prior filing · source: 10-Q · 2026-07-29

• We may be unable to complete the pending strategic acquisition of BioLife in a timely manner or at all, and even if we are able to complete the acquisition, we may be unable to successfully integrate BioLife’s business, any of which could adversely affect our business and financial condition.

• The pending strategic acquisition of BioLife is subject to various closing conditions, many of which are outside of our control. Our inability to complete the pending acquisition of BioLife in a timely manner or at all could have a material adverse effect on our business as our ability to execute on…

• Even if we are able to complete the acquisition, we may be unable to successfully and efficiently integrate BioLife’s business into the Repligen enterprise following the closing.

• Realization of the value from the pending acquisition of BioLife relies on successful and efficient integration following the closing. We may not be able to integrate BioLife’s business successfully into our existing business, retain key employees or realize the anticipated cost savings or synergies…