On November 9, 2021 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three and nine months ended September 30, 2021 (Press release, Eagle Pharmaceuticals, NOV 9, 2021, View Source [SID1234594847]).

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Business and Recent Highlights:

Entered into a worldwide licensing agreement for the commercial rights to CAL02, a novel first-in-class antitoxin agent ready for Phase 2b/3 development for the treatment of severe bacterial pneumonia in combination with traditional antibacterial drugs.
Vasopressin updates:
In August 2021, received favorable decision from the U.S. District Court for the District of Delaware that Eagle’s proposed vasopressin product does not infringe any of the patents Par Pharmaceutical, Inc. asserted against Eagle.
U.S. Food and Drug Administration ("FDA") maintained Priority Review for the Company’s ANDA with December 15, 2021 GDUFA date.
Received a 30-day information request from the FDA; Eagle fully responded to the request on September 20, 2021, and there are no other review requests outstanding.
Granted U.S. Patent No. 11,103,483, "Formulations of Bendamustine," which has been listed in the FDA Orange Book for BENDEKA and BELRAPZO.
Entered into a licensing agreement for the U.S. commercial rights to landiolol, a leading hospital emergency use product in Europe and Japan. Landiolol is currently approved in Europe for the treatment of non-compensatory sinus tachycardia and tachycardic supraventricular arrhythmias. Eagle will support the submission of a new drug application to the FDA seeking approval for landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.
Financial Highlights

Third Quarter 2021

Total revenue for Q3 2021 was $39.9 million, compared to $49.9 million in Q3 2020, primarily reflecting lower product sales of BELRAPZO and BENDEKA, partially offset by higher product sales of TREAKISYM.
Q3 2021 net loss was $5.6 million, or $0.43 per basic and diluted share, compared to net income of $7.1 million, or $0.52 per basic and $0.51 diluted share in Q3 2020.
Q3 2021 adjusted non-GAAP net income was $7.5 million, or $0.57 per basic and $0.56 per diluted share, compared to adjusted non-GAAP net income of $16.1 million, or $1.19 per basic and $1.17 per diluted share, in Q3 2020.
Cash and cash equivalents were $99.7 million, net accounts receivable was $45.3 million, and debt was $28.0 million as of September 30, 2021.
"We are preparing for two significant product launches, vasopressin and PEMFEXY, expected within the next ninety days that we believe will meaningfully increase the revenue and profitability of Eagle. With the recent licensing of CAL02 and landiolol, our expectation going forward is that we will utilize our cash and possibly the balance sheet to further strengthen the pipeline and portfolio," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

Third Quarter 2021 Financial Results

Total revenue for the three months ended September 30, 2021 was $39.9 million, as compared to $49.9 million for the three months ended September 30, 2020.

Q3 2021 BELRAPZO product sales were $4.9 million, compared to $8.7 million in Q3 2020.

Q3 2021 RYANODEX product sales were $4.5 million, compared to $4.2 million in Q3 2020.

Royalty revenue was $27.7 million in the third quarter of 2021, compared to $27.6 million in the third quarter of 2020. BENDEKA royalties were $26.5 million in the third quarter of 2021, compared to $27.6 million in the third quarter of 2020. A summary of total revenue is outlined below:

Gross Margin was 79% during the third quarter of 2021, as compared to 76% in the third quarter of 2020. The increase in gross margin for the third quarter of 2021 was driven by revenue mix.

R&D expense was $23.3 million for the third quarter of 2021, compared to $4.8 million in the third quarter of 2020. The increase includes a $10.0 million upfront payment related to our license agreement with Combioxin for CAL02, a $5.0 million upfront expense related to our licensing agreement with AOP Orphan for landiolol, a $0.8 million increase in development and pre-launch inventory costs for vasopressin and a $1.1 million increase related to PEMFEXY. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the third quarter of 2021 was $7.6 million.

SG&A expenses in the third quarter of 2021 totaled $18.5 million compared to $17.7 million in the third quarter of 2020. This increase is primarily related to higher external legal costs partially offset by a decrease in stock-based compensation expense. Excluding stock-based compensation and other non-cash and non-recurring items, third quarter 2021 SG&A expense was $14.5 million.

Net loss for the third quarter of 2021 was $5.6 million, or $0.43 per basic and diluted share, compared to net income of $7.1 million, or $0.52 per basic and $0.51 per diluted share, in the third quarter of 2020, due to the factors discussed above.

Adjusted non-GAAP net income for the third quarter of 2021 was $7.5 million, or $0.57 per basic and $0.56 per diluted share, compared to adjusted non-GAAP net income of $16.1 million or $1.19 per basic and $1.17 per diluted share in the third quarter of 2020. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

2021 Expense Guidance

R&D spend in 2021, on a non-GAAP basis, is expected to be $34-$38 million, as compared to $27.8 million in 2020.
SG&A spend in 2021, on a non-GAAP basis, is expected to be $52-$56 million, as compared to $50.9 million in 2020.
The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.
Liquidity

As of September 30, 2021, the Company had $99.7 million in cash and cash equivalents plus $45.3 million in net accounts receivable. The Company had $28.0 million in outstanding debt. Therefore, as of September 30, 2021, the Company had net cash plus receivables of $117.0 million.

In the third quarter of 2021, the Company purchased $8.3 million of its common stock as part of its $160.0 million Share Repurchase Program. From August 2016 through September 30, 2021, the Company has repurchased $219.4 million of its common stock.

Conference Call

As previously announced, Eagle management will host its third quarter 2021 conference call as follows:

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-8292 (US) or 402-220-6069 (International) and entering conference call ID EGRXQ321. The webcast will be archived for 30 days at the aforementioned URL.

On November 9, 2021 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported an interim clinical data update from its TCR-engineered cell therapy (TCR-T) approach ACTengine IMA203 targeting PRAME (Press release, Immatics, NOV 9, 2021, View Source [SID1234594863]). Data from patients treated at the first three of four dose levels of the ongoing IMA203 Phase 1a dose escalation study show a high preliminary objective response rate (partial responses according to RECIST 1.1) at doses below 1 billion total transduced cells. The data will be presented as a late-breaking oral presentation on Saturday, November 13 at 12:00-12:15 pm EST at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). In addition, Immatics will present preclinical proof-of-concept data for its next-generation IMA203CD8 candidate at the SITC (Free SITC Whitepaper) Annual Meeting on Friday, November 12 and will provide an overall update on all IMA200 programs including IMA201 (MAGEA4/A8) and IMA202 (MAGEA1) in a conference call on November 9, 2021 at 8:30 am EST.

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Key clinical findings from IMA203 Phase 1a trial
In the ongoing ACTengine IMA203 trial, Immatics is treating advanced solid cancer patients utilizing TCR-T cells directed against an HLA-A*02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME). PRAME is homogenously expressed and highly prevalent across several solid cancer indications. The chosen PRAME target peptide has been identified by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT, demonstrating natural and specific occurrence of the target on tumors at high copy numbers.

Clinical and biological activity: IMA203 demonstrates objective responses (RECIST 1.1.) at low cellular doses across several solid cancer types

At data cut-off on October 5, 2021, 18 patients received ACTengine IMA203 T cells across dose level 1 (DL1) to dose level 4 (DL4).
All patients were heavily pretreated with a median of 4 lines of prior systemic treatment.
16 patients were evaluable for tumor response analysis according to RECIST 1.1 with at least one post-treatment tumor assessment at the time of data cut-off. All 16 patients received dose levels 1 to 3 – below 1 billion total transduced cells. For the remaining 2 patients, the first tumor response assessment is still pending.
15 out of 16 patients (94%) achieved disease control. Tumor shrinkage was observed in 14 patients (88%).
8 out of 16 patients (50%) showed objective responses; onset of responses in all cases was detected within 6 weeks following infusion of IMA203 T cells.
All responses occurred above DL1; 8 out of 13 patients (62%) treated at DL20F1 and DL3 receiving up to 0.59 billion total transduced cells had objective partial responses. Responses were observed in patients with synovial sarcoma, malignant melanoma, uveal melanoma, and head and neck cancer.
As of data cut-off, partial responses were confirmed in subsequent scans in two synovial sarcoma patients and one uveal melanoma patient.
Longer follow-up is required for patients infused at higher dose levels DL3 and DL4 are required to assess response durability and response rate at target dose.
IMA203 continues to show high levels of T cell engraftment, persistence, and tumor infiltration at first three dose levels. Clinical response was associated (p=0.016) with infiltration of IMA203 T cells into the tumor tissue and showed an emerging trend towards higher peak vector copies of IMA203 T cells in blood (p=0.065) – supporting the mechanism-of-action.
The ACTengine IMA203 trial is currently recruiting patients to the 4th and highest dose level (up to approximately 2.5 billion total transduced cells) of the Phase 1a dose escalation cohort.
Preliminary Objective Response Rates (ORR; RECIST 1.1, confirmed and unconfirmed)

Dose Level ORR
DL1 0/3 (0%)
DL21 6/10 (60%)
DL3 2/3 (67%)

All dose levels DL21 & DL3
All comers 8/16 (50%) 8/13 (62%)
Melanoma 3/3 (100%) 3/3 (100%)
Head & Neck Cancer 1/3 (33%) 1/1 (100%)
Synovial Sarcoma 3/5 (60%) 3/5 (60%)
Uveal Melanoma 1/2 (50%) 1/2 (50%)
Safety: IMA203 treatment was well tolerated with transient and manageable treatment-emergent adverse events (TEAEs)

At data cut-off on October 5, 2021, 19 patients were evaluable for safety analysis.
Most frequent TEAEs included expected transient cytopenia (Grade 1-4) associated with lymphodepletion and transient low to moderate (Grade 1-2) cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS).
No additional dose limiting toxicities (DLT) were observed since the previous data release on March 17, 2021.

"We observed multiple clinical responses early-on during dose escalation and saw anti-tumor activity at much lower doses than would have been expected in the field of TCR-T. IMA203 T cells will now be tested at the target dose level and have the potential to provide meaningful benefits to patients with advanced stages of cancer," commented Martin Wermke, MD, Coordinating Investigator of Immatics’ ACTengine trials in Germany and Head of the Early Clinical Trial Unit of the National Center for Tumor Diseases at the University Hospital Carl Gustav Carus in Dresden, Germany. "I am looking forward to presenting this exciting data set to the scientific and medical community at SITC (Free SITC Whitepaper) and to supporting the further development of IMA203."

Following the completion of the dose escalation portion of the study (Phase 1a) and the determination of the recommended Phase 2 dose (RP2D), Immatics plans to expand the IMA203 study to multiple Phase 1b (dose expansion) study cohorts:

IMA203 as a monotherapy
IMA203 in combination with an immune checkpoint inhibitor
IMA203CD8, next-generation TCR-T where IMA203 cells are co-transduced with a CD8 co-receptor

Cedrik Britten, M.D., Chief Medical Officer at Immatics, commented: "The unexpected high clinical response rate in PRAME-positive patients before reaching our target cell dose has shifted our expectations of what cell therapy could potentially achieve in solid cancers. This is a very promising first step, which encourages us to double down efforts for a focused development strategy of our programs targeting PRAME. Our immediate next steps aim to maximize the benefit for PRAME-positive patients through (1) ACTengine IMA203 monotherapy at target dose, (2) combination with checkpoint inhibitors, and (3) our efficacy-enhanced next-gen TCR-T approach ACTengine IMA203CD8. In addition, we are gearing up for clinical testing of our off-the-shelf Bispecifics program, TCER IMA402 targeting PRAME, which has the potential of delivering transformational benefits for patients, combined with the advantages of easy and fast supply at significantly reduced cost of goods."

Preclinical update on next-generation ACTengine IMA203CD8
IMA203CD8 consists of IMA203-engineered T cells targeting PRAME co-transduced with CD8αβ T cell co-receptor that plays an important role during T cell antigen recognition and T cell activation. The IMA203CD8 product candidate has the potential to harness the potency of CD4 T cells. Engagement of CD4 T cells, in addition to CD8 T cells, might further enhance depth and durability of anti-tumor response and clinical outcome of TCR-T in solid cancer patients.

Immatics has exclusively licensed the CD8αβ technology from Baylor College of Medicine in Houston, Texas.
IMA203CD8 product candidate demonstrates enhanced anti-tumor activity in preclinical proof-of-concept data, which will be presented on-site at the SITC (Free SITC Whitepaper) Annual Meeting on Friday, November 12, 2021 between 7 am – 8:30 pm EST as well as virtually throughout the duration of the conference. The poster will also be available on Immatics’ website following the poster presentation.
IND submission for IMA203CD8 cohort is expected in the first half of 2022.

Further updates on the ACTengine IMA200 Programs

IMA201 (MAGEA4/A8) and IMA202 (MAGEA1)

The dose escalation Phase 1a study with ACTengine IMA201 and IMA202 product candidates directed at MAGEA4/8 and MAGEA1 HLA-A*02 peptides respectively, continue to advance with IMA202 at dose level 3 and IMA201 at dose level 2.
At data cut-off on September 17, 2021, 12 heavily pretreated patients have been treated; 8 out of 12 patients showed disease control. Tumor shrinkage was observed in 6 patients.
All treatment-emergent adverse events (TEAEs) for both IMA201 and IMA202 continue to be transient and manageable. No dose limiting toxicities (DLT) or higher grade CRS/ICANS have been observed.
The next step in the IMA201 and IMA202 trials is to complete dose escalation including target dose (DL3).
IMA204 (COL6A3 exon 6)

ACTengine IMA204 is a potential first-in-class TCR-T directed against COL6A3 exon 6, a novel tumor stroma target highly expressed in several solid cancers. IMA204 utilizes a next-generation CD8-independent TCR with full functionality in both CD4 and CD8 T cells.
IND-enabling studies are close to completion. Submission of the IND application for IMA204 is now expected in 2022 to allow accelerated initiation of the multiple ACTengine IMA203 Ph1b cohorts.
1DL2 here includes patients dosed with DL2, EC1 and EC2 (EC1: Enrichment cohort with intermediate dose level between DL1 and DL2 , EC2: between DL2 and DL3)

Immatics conference call
Immatics will host a conference call on Tuesday, November 9, 2021 at 8:30 am EST / 2:30pm CET to discuss these clinical data and the company’s comprehensive strategy to target PRAME via different programs. The webcast and presentation can be accessed directly through this link. Participants may also access the slides and the webcast on the Immatics website in the Investors section under "Presentations" at www.investors.immatics.com/events-presentations. A replay of the webcast will be made available shortly after the conclusion of the call and archived on the Company’s website for at least 90 days.

About Immatics’ PRAME Programs
Immatics’ PRAME programs are directed against an HLA-A*02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers – such as uterine carcinoma, synovial sarcoma, melanoma, ovarian carcinoma, uveal melanoma, squamous NSCLC, breast carcinoma and HNSCC – thereby supporting the programs’ potential to address a broad cancer patient population. Immatics’ PRAME peptide demonstrates a high copy number per tumor cell and is homogenously and specifically expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT. Through its proprietary TCR discovery and engineering platform XCEPTOR, the Company has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine IMA203, and its TCR Bispecifics pipeline, TCER IMA402. Both therapeutic modalities have distinct attributes and mechanisms of actions suitable for cancer patients at different disease stages and tumor types.

ACTengine IMA203 is currently being evaluated in an ongoing Phase 1a dose escalation cohort utilizing a 3+3 design with four increasing IMA203 dose levels to determine the Recommended Phase 2 Dose (RP2D). Immatics plans to expand the IMA203 study to multiple Phase 1b study cohorts including (1) IMA203 as a monotherapy, (2) IMA203 in combination with an immune checkpoint inhibitor and (3) IMA203CD8, a next-generation cell therapy where IMA203 engineered T cells are co-transduced with a CD8αβ co-receptor.

TCER IMA402 is a PRAME-specific "off-the-shelf" biologic that leverages the body’s immune system by redirecting and activating T cells towards cancer cells. TCER IMA402 has previously demonstrated anti-tumor activity against PRAME-positive cancer cells in an in vivo mouse model leading to consistent tumor regression including complete responses.

About ACTengine programs
ACTengine is a personalized approach for patients with advanced solid tumors. The patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor, an approach also known as TCR-T. ACTengine programs IMA201 (NCT03247309), IMA202 (NCT03441100) and IMA203 (NCT03686124) are currently in clinical development in the US and in Germany. The objective of the three Phase 1 clinical trials is to evaluate safety, tolerability and initial signs of clinical and biological efficacy in target-positive solid cancer patients. IMA204 is currently in pre-clinical development. All ACTengine product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.

The ACTengine T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth. The ACTengine IMA200 Programs are co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).

On November 9, 2021 Sanofi reported the completion of its acquisition of Kadmon Holdings, Inc. The acquisition further strengthens growth and expansion for the General Medicines portfolio (Press release, Sanofi, NOV 9, 2021, View Source [SID1234594879]).

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Shareholders of Kadmon common stock voted to approve the acquisition at a special meeting of stockholders on November 5, 2021 and will receive $9.50 per share in cash, which represents a total equity value of approximately $1.9 billion (on a fully diluted basis).

Sanofi completed its acquisition of Kadmon through the merger of a wholly owned subsidiary of Sanofi with and into Kadmon, pursuant to Section 251 of the General Corporation Law of the State of Delaware, with Kadmon continuing as the surviving corporation and becoming an indirect, wholly owned subsidiary of Sanofi.

As of November 9, 2021, Kadmon common stock will cease to be traded on the NASDAQ Global Select Stock Market and will be subsequently deregistered.

Centerview Partners acted as exclusive financial advisor to Sanofi while Weil, Gotshal & Manges LLP acted as legal counsel to Sanofi. Cantor Fitzgerald & Co. and Moelis & Company LLC acted as exclusive financial advisors to Kadmon in the transaction, while DLA Piper LLP (US) acted as legal counsel. H.C. Wainwright & Co., LLC acted as capital markets advisor to Kadmon management.

On November 9, 2021 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that members of the management team will participate at the following investor conferences (Press release, Neurocrine Biosciences, NOV 9, 2021, View Source [SID1234594895]):

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Kevin Gorman, Chief Executive Officer, and Matt Abernethy, Chief Financial Officer will present at the Jefferies London Healthcare Conference at 1:00 p.m. Greenwich Mean Time (8:00 a.m. Eastern Time) on Tuesday, Nov. 16, 2021 in London.
Matt Abernethy, Chief Financial Officer, and Eiry Roberts, Chief Medical Officer, will present at the Evercore ISI 4th Annual HealthCONx Virtual Conference at 10:55 a.m. Eastern Time on Tuesday, Nov. 30, 2021.
The live presentations will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentations will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

On November 9, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO) ("Thermo Fisher") reported that it has priced an offering of €2.8 billion aggregate principal amount (the "Offering") of the following euro-denominated notes, which will be issued by Thermo Fisher Scientific (Finance I) B.V., its indirect, wholly owned finance subsidiary (Press release, Thermo Fisher Scientific, NOV 9, 2021, View Source [SID1234594911]):

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€1,700,000,000 aggregate principal amount of its floating rate senior notes due 2023 (the "floating rate notes"), at the issue price of 100.744% of their principal amount,
€550,000,000 aggregate principal amount of its 0.000% senior notes due 2023 (the "2023 notes"), at the issue price of 100.321% of their principal amount, and
€550,000,000 aggregate principal amount of its 0.000% senior notes due 2025 (the "sustainability notes" and together with the floating rate notes and the 2023 notes, the "notes"), at the issue price of 99.868% of their principal amount.
The Offering is expected to close on or about November 18, 2021, subject to customary closing conditions. The notes will be fully and unconditionally guaranteed by Thermo Fisher. The floating rate notes will pay interest quarterly.

Thermo Fisher intends to use the net proceeds from the sale of the floating rate notes and the 2023 notes to pay a portion of the cash consideration payable for the pending acquisition of PPD, Inc. ("PPD"). Thermo Fisher may also determine to use a portion of the net proceeds from the sale of the floating rate notes and the 2023 notes for general corporate purposes, which may include the acquisition of companies or businesses, repayment and refinancing of debt, including debt of PPD, working capital and capital expenditures or the repurchase of its outstanding equity securities or it may temporarily invest the net proceeds in short-term, liquid investments until they are used for their ultimate purpose.

Thermo Fisher intends to allocate an amount equal to the net proceeds from the sale of the sustainability notes to finance or refinance, in whole or in part, certain green or social eligible projects. Pending allocation to green or social eligible projects, such net proceeds may be temporarily invested in cash, cash equivalents, short-term investments, or used to repay other borrowings.

The joint book-running managers for the Offering are Barclays Bank PLC, Morgan Stanley Europe SE, BofA Securities Europe SA, Citigroup Global Markets Europe AG and Mizuho Securities Europe GmbH. Barclays Bank PLC is also acting as the sustainability structuring agent for the sustainability notes.

The Offering is being made pursuant to an effective registration statement on Form S-3 filed with the U.S. Securities and Exchange Commission (the "SEC"). Prospective investors should read the prospectus forming a part of that registration statement and the prospectus supplement related to the Offering and the other documents that Thermo Fisher has filed with the SEC for more complete information about Thermo Fisher and the Offering. These documents are available at no charge by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, Thermo Fisher, the underwriters or any dealer participating in the Offering will arrange to send you the prospectus if you request it by calling Barclays Bank PLC at +1 888 603 5847, Morgan Stanley Europe SE at +44 (0)20 7677 4799, BofA Securities Europe SA at +33(0) 1 8770 0000, Citigroup Global Markets Europe AG at +49 69 1366 8362 or Mizuho Securities Europe GmbH at +49 69 42729 3000.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the notes, nor shall there be any offer, solicitation or sale of the notes in any jurisdiction in which such offer, solicitation or sale would be unlawful.

MiFID II and UK MiFIR – professionals/ECPs-only / No PRIIPs or UK PRIIPs KID – Manufacturer target market (MiFID II and UK MiFIR product governance) is eligible counterparties and professional clients only (all distribution channels). No PRIIPs or UK PRIIPs key information document (KID) has been prepared as not available to retail in European Economic Area ("EEA") or United Kingdom ("UK").

This press release is addressed only to specific individuals who are individuals (i) who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order") and qualified investors falling within Article 49(2)(a) to (d) of the Order and (ii) to whom it may otherwise lawfully be communicated under the Order (all such persons together being referred to as the "relevant persons"). This press release must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this press release relates is available only to relevant persons and will be engaged in only with relevant persons. By reading this press release, the reader acknowledges that it is a person either (i) outside the UK or (ii) falling within one of the foregoing categories.

This press release is an advertisement and is not a prospectus for the purposes of Prospectus Regulation (as defined below). A prospectus will be prepared and made available to the public as required and in accordance with the Prospectus Regulation. Investors should not subscribe for any notes referred to in this press release except on the basis of information contained in such prospectus. The prospectus, when published, will be available on the website of Euronext Dublin at https://live.euronext.com (opens in a new tab).

For these purposes, the expression "Prospectus Regulation" means either Regulation (EU) 2017/1129 or Regulation (EU) 2017/1129 as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018, as appropriate.

In connection with the issue of the notes, Morgan Stanley Europe SE (the "Stabilising Manager") (or persons acting on behalf of the Stabilising Manager) may over-allot notes or effect transactions with a view to supporting the market price of the notes at a level higher than that which might otherwise prevail. However, there is no assurance that the Stabilising Manager (or persons acting on behalf of the Stabilising Manager) will undertake stabilisation action. Any stabilisation action may begin on or after the date in which adequate public disclosure of the final terms of the Offering is made and, if begun, may be ended at any time, but it must end no later than the earlier of 30 days after the issue date of the notes and 60 days after the date of the allotment of the notes. Any stabilisation action or overallotment must be conducted by the Stabilising Manager (or persons acting on behalf of the Stabilising Manager) in accordance with all applicable laws and rules.

This press release is released by Thermo Fisher Scientific (Finance I) B.V. and contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) 596/2014 ("MAR"). For the purposes of MAR, this press release is made by Sharon Briansky at Thermo Fisher Scientific (Finance I) B.V.

The legal entity identifier of Thermo Fisher International is 549300SM0PJC1F3RPL91.