RNA 9000 Purity and Integrity Kit Allows for Critical High-Resolution Analysis for mRNA Therapeutics

Broad range RNA integrity and quality analysis kit for SCIEX capillary electrophoresis instruments launches at TIDES 2022

At TIDES 2022, SCIEX , a global leader in life science analytical technologies, and a company of Danaher Corporation (NYSE:DHR), launches the RNA 9000 Purity & Integrity kit, for the BioPhase 8800 system and PA 800 Plus system.

As genomic medicine takes center stage and the demand for RNA-based therapeutics and vaccines grows, the integrity and quality of RNA species is increasingly important. Scientists have been faced with complex methods that have low resolution and poor transferability, as they work to accelerate therapeutic drug development and meet critical timelines. For intact mRNA analysis, scientists need validated, production-ready methods and instrument platforms that allow them to confidently distinguish desired therapeutic products from unwanted impurities.

This RNA 9000 Purity and Integrity kit is a purpose-built, high resolution analysis method for mRNA therapeutics. It was specifically designed to provide significantly higher resolution for a wide variety of therapeutically-relevant mRNA classes, from 50-9,000 bases.

"For scientists, this kit has the power and capability to transform the analysis of mRNA therapeutics and vaccines. Not only can it be used for final product quality control to assess quality and length post nanoparticle or viral vector encapsulation, but it can also be used during early-stage development immediately following IVT (in-vitro transcribe) to ensure the integrity and size of the mRNA payload is what the researchers are targeting. This kit is truly a unique solution with its analytical resolution," said Jérémie Parot PhD, Research Scientist at SINTEF.

"The ability to help biopharmaceutical developers accelerate the development of RNA-based medicines and bridge the developability gap can bring more life-changing medicines to market," said Susan Darling, Senior Director of CE and Biopharma at SCIEX. "Compatibility with both the BioPhase 8800 system and the PA 800 Plus system means scientists have the ability to run the assay in a 21cfr part 11b compliant way, across instruments, across sites, across the globe."

With this kit, scientists could expect to:

Minimize time to market with exceptional reproducibility, experiment to experiment
Estimate a target therapeutic size
Experiment with minimal sample material and have the ability to detect low level impurities present in samples

To learn more about RNA 9000 Purity and Integrity kit, see here .

About SCIEX

SCIEX delivers solutions for the precision detection and quantification of molecules, empowering our customers to protect and advance the wellness and safety of all. We have been at the forefront of the field of mass spectrometry for 50 years. From the launch of the first ever commercially successful triple quadrupole in 1981, we have developed groundbreaking technologies and solutions that influence life-changing research and outcomes.

Today, as part of the Danaher Corporation (NYSE:DHR) family of global science and technology companies, we continue to pioneer robust solutions in mass spectrometry and capillary electrophoresis. Our customers can quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster and keep food healthier and safer.

That's why thousands of life science experts around the world choose SCIEX to get the answers they can trust to better inform critical decisions that positively impact lives.

For more information, visit sciex.com .

Let's connect: Twitter , LinkedIn , Facebook , and Instagram .

Advances in human wellness depend on the power of precise science.

The SCIEX clinical diagnostic portfolio is For In Vitro Diagnostic Use. Rx Only. Product(s) not available in all countries. For information on availability, please contact your local sales representative or refer to www.sciex.com/diagnostics . All other products are For Research Use Only. Not for use in Diagnostic Procedures.

Trademarks and/or registered trademarks mentioned herein, including associated logos, are the property of AB Sciex Pte. Ltd. or their respective owners in the United States and/or certain other countries (see www.sciex.com/trademarks ).

View source version on businesswire.com: https://www.businesswire.com/news/home/20220509005736/en/

Lulu VanZandt
Senior Manager, Brand, Public Relations and Social Media
lulu.vanzandt@sciex.com
M: +1 (508) 782-9484

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Danaher Corporation AND SUBSIDIARIES
CONSOLIDATED CONDENSED STATEMENTS OF EARNINGS
($ and shares in millions, except per share amounts)
(unaudited)

	Three-Month Period Ended
	March 31, 2023	April 1, 2022
Sales	{replace1}nbsp; 7,167	{replace1}nbsp; 7,688
Cost of sales	(2,797)	(2,983)
Gross profit	4,370	4,705
Operating costs:
Selling, general and administrative expenses	(2,147)	(2,092)
Research and development expenses	(429)	(441)
Operating profit	1,794	2,172
Nonoperating income (expense):
Other income (expense), net	24	(20)
Interest expense	(68)	(54)
Interest income	48	1
Earnings before income taxes	1,798	2,099
Income taxes	(348)	(374)
Net earnings	1,450	1,725
Mandatory convertible preferred stock dividends	(21)	(41)
Net earnings attributable to common stockholders	{replace1}nbsp; 1,429	{replace1}nbsp; 1,684
Net earnings per common share:
Basic	{replace1}nbsp; 1.96	{replace1}nbsp; 2.35
Diluted	{replace1}nbsp; 1.94	{replace1}nbsp; 2.31
Average common stock and common equivalent shares outstanding:
Basic	729.4	716.3
Diluted	737.2	737.7

Danaher Corporation RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES
Diluted Net Earnings Per Common Share and Adjusted Diluted Net Earnings Per Common Share ¹

	Three-Month Period Ended
	March 31, 2023	April 1, 2022
Diluted Net Earnings Per Common Share (GAAP)	{replace1}nbsp; 1.94	{replace1}nbsp; 2.31
Amortization of acquisition-related intangible assets ^A	0.52	0.52
Fair value net (gains) losses on investments ^B	(0.03)	0.03
Separation costs ^C	0.04	—
Loss on partial settlement of a defined benefit plan ^D	—	0.01
Impairments and other charges ^E	—	0.06
Tax effect of the above adjustments ^F	(0.10)	(0.11)
Discrete tax adjustments ^G	(0.01)	(0.06)
Adjusted Diluted Net Earnings Per Common Share (Non-GAAP)	{replace1}nbsp; 2.36	{replace1}nbsp; 2.76

	Three-Month Period Ended
	March 31, 2023	April 1, 2022
Pretax	{replace1}nbsp; 384	{replace1}nbsp; 386
After-tax	310	311

	Three-Month Period Ended
	March 31, 2023	April 1, 2022
Pretax	{replace1}nbsp; (22)	{replace1}nbsp; 24
After-tax	(17)	18


^C	Costs incurred in the three-month period ended March 31, 2023 related to preparation for the anticipated separation of the Company's Environmental & Applied Solutions business primarily related to professional fees for legal, tax, finance and information technology services and duplicative general and administrative costs ($28 million pretax as reported in this line item, $25 million after-tax).

^D	Loss on a partial settlement of a defined benefit plan as a result of the transfer of a portion of the Company's non-U.S. pension liabilities related to one defined benefit plan to a third-party in the three-month period ended April 1, 2022 ($10 million pretax as reported in this line item, $9 million after-tax).

^E	Charges incurred primarily related to impairments of accounts receivable and inventory as well as accruals for contractual obligations in Russia incurred in the three-month period ended April 1, 2022 ($43 million pretax as reported in this line item, $40 million after-tax).

^F	This line item reflects the aggregate tax effect of all nontax adjustments reflected in the preceding line items of the table. In addition, the footnotes above indicate the after-tax amount of each individual adjustment item. Danaher estimates the tax effect of each adjustment item by applying Danaher's overall estimated effective tax rate to the pretax amount, unless the nature of the item and/or the tax jurisdiction in which the item has been recorded requires application of a specific tax rate or tax treatment, in which case the tax effect of such item is estimated by applying such specific tax rate or tax treatment. The MCPS dividends are not tax deductible and therefore the tax effect of the adjustments does not include any tax impact of the MCPS dividends.

^G	Discrete tax adjustments and other tax-related adjustments for the three-month period ended March 31, 2023, include the impact of net discrete tax benefits of $5 million related primarily to excess tax benefits from stock-based compensation and the release of reserves for uncertain tax positions due to the expiration of statutes of limitation, partially offset by tax costs related to the separation of the Environmental & Applied Solutions business and changes in estimates associated with prior period uncertain tax positions. Discrete tax adjustments and other tax-related adjustments for the three-month period ended April 1, 2022, include the impact of net discrete tax benefits of $41 million related primarily to excess tax benefits from stock-based compensation and the changes in estimates associated with prior period uncertain tax positions.


¹	Each of the per share adjustment amounts above have been calculated assuming the Mandatory Convertible Preferred Stock ("MCPS") had been converted into shares of common stock.

Notes to Reconciliation of GAAP to Non-GAAP Financial Measures

^A	Amortization of acquisition-related intangible assets in the following historical periods (only the pretax amounts set forth below are reflected in the amortization line item above):


^B	Net (gains) losses on the Company's equity and limited partnership investments recorded in the following historical periods (only the pretax amounts set forth below are reflected in the fair value net (gains) losses on investments line above):

Average and Adjusted Average Common Stock and Common Equivalent Diluted Shares Outstanding
(shares in millions)

	Three-Month Period Ended
	March 31, 2023	April 1, 2022
Average common stock and common equivalent shares outstanding - diluted (GAAP) ²	737.2	737.7
Converted shares ³	8.6	8.6
Adjusted average common stock and common equivalent shares outstanding - diluted (non-GAAP)	745.8	746.3


²	The impact of the MCPS Series B calculated under the if-converted method was anti-dilutive for the three-month periods ended March 31, 2023 and April 1, 2022, and as such 8.6 million shares underlying the MCPS Series B were excluded from the calculation of diluted EPS in both periods and the related MCPS Series B dividends of $21 million were included in the calculation of net earnings for diluted EPS for the periods.

	The impact of the MCPS Series A calculated under the if-converted method was dilutive for the three-month period ended April 1, 2022, and as such 11.0 million shares underlying the MCPS Series A were included in the calculation of diluted EPS in the three-month period and the related MCPS Series A dividends of $20 million were excluded from the calculation of net earnings for diluted EPS.

³	The number of converted shares assumes the conversion of all MCPS and issuance of the underlying shares applying the "if-converted" method of accounting and using an average 20 trading-day trailing Volume Weighted Average Price ("VWAP") of $246.26 and $281.28 as of March 31, 2023 and April 1, 2022, respectively.

Sales (Decline) Growth by Segment, Core Sales (Decline) Growth by Segment and Base Business Core Sales Growth by Segment

	% Change Three-Month Period Ended March 31, 2023 vs. Comparable 2022 Period
		Segments
	Total Company	Biotechnology	Life Sciences	Diagnostics	Environmental & Applied Solutions
Total sales (decline) growth (GAAP)	(7.0) %	(16.0) %	2.5 %	(10.0) %	5.0 %
Impact of:
Acquisitions/divestitures	— %	— %	(1.0) %	— %	(0.5) %
Currency exchange rates	3.0 %	3.0 %	3.5 %	2.5 %	2.0 %
Core sales (decline) growth (non-GAAP)	(4.0) %	(13.0) %	5.0 %	(7.5) %	6.5 %
Impact of COVID-19 related testing, vaccines and therapeutics	10.0 %	+Low-teens	+Low-single digit	+High-teens	— %
Base business core sales growth (non-GAAP)	6.0 %	Flat	+High-single digit	+Low-double digit	6.5 %

Forecasted Core Sales (Decline) Growth and Base Business Core Sales Growth

The Company provides forecasted sales only on a non-GAAP basis because of the difficulty in estimating the other components of GAAP revenue, such as currency translation, acquisitions and divested product lines.

	% Change Three-Month Period Ending June 30, 2023 vs. Comparable 2022 Period	% Change Year Ending December 31, 2023 vs. Comparable 2022 Period
Core sales (decline) growth (non-GAAP)	-High-single digit	-High-single digit
Impact of COVID-19 related testing, vaccines and therapeutics	+Low-double digit	+Low-double digit
Base business core sales growth (non-GAAP)	+Mid-single digit	+Mid-single digit

Operating Profit Margins and Year-Over-Year Core Operating Margin Changes

			Segments
		Total Company	Biotechnology	Life Sciences	Diagnostics	Environmental & Applied Solutions
Three-Month Period Ended April 1, 2022 Operating Profit Margins (GAAP)		28.30 %	36.10 %	19.10 %	33.50 %	20.30 %
	First quarter 2023 impact from operating profit margins of businesses that have been owned for less than one year	(0.15)	(0.15)	(0.45)	—	0.15
	First quarter 2022 impairments of accounts receivable and inventory as well as accruals for contractual obligations in Russia	0.55	0.60	1.45	0.10	0.10
	First quarter 2023 costs incurred related to preparation for the anticipated separation of the Company's Environmental & Applied Solutions business	(0.40)	—	—	—	—
Year-over-year core operating profit margin changes for the first quarter 2023 (defined as all year-over-year operating profit margin changes other than the changes identified in the line items above) (non-GAAP)		(3.30)	(4.55)	(1.30)	(5.10)	3.95
Three-Month Period Ended March 31, 2023 Operating Profit Margins (GAAP)		25.00 %	32.00 %	18.80 %	28.50 %	24.50 %

Cash Flow and Free Cash Flow
($ in millions)

	Three-Month Period Ended		Year-over-Year Change
	March 31, 2023	April 1, 2022	Year-over-Year Change
Total Cash Flows:
Net cash provided by operating activities (GAAP)	{replace1}nbsp; 1,947	{replace1}nbsp; 1,968
Total cash used in investing activities (GAAP)	{replace1}nbsp; (304)	{replace1}nbsp; (503)
Total cash used in financing activities (GAAP)	{replace1}nbsp; (262)	{replace1}nbsp; (274)

Free Cash Flow:
Net cash provided by operating activities (GAAP)	{replace1}nbsp; 1,947	{replace1}nbsp; 1,968	~ (1.0)%
Less: payments for additions to property, plant & equipment (capital expenditures) (GAAP)	(275)	(250)
Plus: proceeds from sales of property, plant & equipment (capital disposals) (GAAP)	—	2
Free cash flow (non-GAAP)	{replace1}nbsp; 1,672	{replace1}nbsp; 1,720	~ (3.0)%

Contacts:
Erika Winkels	Ryan Weispfenning
Public Relations	Investor Relations
+1-763-526-8478	+1-763-505-4626

Investor Contact:		Media Contact:
Garen Sarafian		Katie Savastano
ir@bauschhealth.com		corporate.communications@bauschhealth.com
877-281-6642 (toll-free)		(908) 569-3692

RNA 9000 Purity and Integrity Kit Allows for Critical High-Resolution Analysis for mRNA Therapeutics

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Craig Cooper – Chief Executive Officer and Executive Director

Niall Cairns - Executive Chairman

King Nelson – Non-executive Director

Charlie Taylor – Non-executive Director

Sanjeev Bhavnani – Chief Clinical Officer

Catherine Liao – Chief Strategy Officer

Mark Gorelick – Chief Product Officer

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