Life Science News

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the first quarter ended April 2, 2022.

First Quarter 2022 Highlights

  • First quarter revenue was $11.82 billion.
  • First quarter GAAP diluted earnings per share (EPS) was $5.61.
  • First quarter adjusted EPS was $7.25.
  • Delivered very strong financial results in the first quarter, with 16% Core organic growth and $1.68 billion of COVID-19 testing revenue.
  • Strengthened our unique customer value proposition with the opening of a new biorepository in Vacaville, California, to advance our cell and gene therapy services. We also brought additional bioproduction capacity online for single-use containers and cell culture media.
  • Reflecting the customer value proposition for our pharma and biotech customers, and as an example of our trusted partner status, Moderna announced a 15-year strategic collaboration agreement with Thermo Fisher to enable large-scale U.S. manufacturing of future mRNA-based vaccines and therapies.
  • Building on our environmental, social and governance priorities and enabling broad adoption of sustainable solutions, we exceeded the milestone of shipping more than one million readily recyclable paper coolers to transport cold-chain products without the use of traditional polystyrene foam coolers.
  • Repurchased $2.0 billion of stock and increased our dividend by 15 percent.

"We are very pleased to deliver another quarter of excellent performance," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "We started the year with great momentum, executing our proven growth strategy and continuing to be a trusted partner for our customers. Our PPD clinical research business is performing very well, the integration is going smoothly and we are even more excited about the opportunities we have to further enable the success of our pharma and biotech customers."

Casper added, "The strong execution by our team in the first quarter positions us to deliver another outstanding year."

First Quarter 2022

Revenue for the quarter grew 19% to $11.82 billion in 2022. Organic revenue growth was 3%, acquisitions increased revenue by 18% and currency translation decreased revenue by 2%. Core organic growth was 16%. COVID-19 testing revenue was $1.68 billion.

GAAP Earnings Results

GAAP diluted EPS in the first quarter of 2022 was $5.61, versus $5.88 in the same quarter last year. GAAP operating income for the first quarter of 2022 was $2.82 billion, compared with $3.05 billion in the year-ago quarter. GAAP operating margin was 23.9%, compared with 30.8% in the first quarter of 2021.

Non-GAAP Earnings Results

Adjusted EPS in the first quarter of 2022 was $7.25, versus $7.21 in the first quarter of 2021. Adjusted operating income for the first quarter of 2022 was $3.45 billion, compared with $3.51 billion in the first quarter of 2021. Adjusted operating margin was 29.2%, compared with 35.4% in the first quarter of 2021.

Annual Guidance for 2022

The company will provide updated 2022 financial guidance during its earnings conference call this morning at 8:30 a.m. Eastern Daylight Time.

Use of Non-GAAP Financial Measures

Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and Core organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, April 28, at 8:30 a.m. Eastern Daylight Time. To listen, dial (844) 200-6205 within the U.S. or (929) 526-1599 outside the U.S. The access code is 310385. You may also listen to the call live on our website, www.thermofisher.com , by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financials." An audio archive of the call will be available under "News and Events" through Friday, May 13, 2022.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com .

Safe Harbor Statement

The following constitutes a "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements that involve a number of risks and uncertainties. Important factors that could cause actual results to differ materially from those indicated by forward-looking statements include risks and uncertainties relating to: the duration and severity of the COVID-19 pandemic; the need to develop new products and adapt to significant technological change; implementation of strategies for improving growth; general economic conditions and related uncertainties; dependence on customers' capital spending policies and government funding policies; the effect of economic and political conditions and exchange rate fluctuations on international operations; use and protection of intellectual property; the effect of changes in governmental regulations; any natural disaster, public health crisis or other catastrophic event; and the effect of laws and regulations governing government contracts, as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected. Additional important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in our most recent annual report on Form 10-K, which is on file with the SEC and available in the "Investors" section of our website under the heading "SEC Filings." While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if estimates change and, therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.

Condensed Consolidated Statement of Income (unaudited)

Three months ended

April 2,

% of

April 3,

% of

(In millions except per share amounts)

2022

Revenues

2021

Revenues

Revenues

$

11,818

$

9,906

Costs and operating expenses:

Cost of revenues (a)

6,214

52.6

%

4,557

46.0

%

Selling, general and administrative expenses (b)

1,808

15.3

%

1,543

15.6

%

Amortization of acquisition-related intangible assets

609

5.2

%

423

4.3

%

Research and development expenses

364

3.1

%

320

3.2

%

Restructuring and other costs (c)

2

0.0

%

14

0.1

%

8,997

76.1

%

6,857

69.2

%

Operating income

2,821

23.9

%

3,049

30.8

%

Interest income

18

12

Interest expense

(136

)

(125

)

Other income/(expense) (d)

(163

)

(183

)

Income before income taxes

2,540

2,753

Provision for income taxes (e)

(301

)

(416

)

Equity in earnings/(losses) of unconsolidated entities

(19

)

Net income

2,220

2,337

Less: net income attributable to noncontrolling interests and redeemable noncontrolling interest

5

Net income attributable to Thermo Fisher Scientific Inc.

$

2,215

18.7

%

$

2,337

23.6

%

Earnings per share attributable to Thermo Fisher Scientific Inc.:

Basic

$

5.66

$

5.93

Diluted

$

5.61

$

5.88

Weighted average shares:

Basic

392

394

Diluted

395

397

Reconciliation of adjusted operating income and adjusted operating margin

GAAP operating income

$

2,821

23.9

%

$

3,049

30.8

%

Cost of revenues adjustments (a)

11

0.1

%

8

0.1

%

Selling, general and administrative expenses adjustments (b)

7

0.0

%

16

0.1

%

Restructuring and other costs (c)

2

0.0

%

14

0.1

%

Amortization of acquisition-related intangible assets

609

5.2

%

423

4.3

%

Adjusted operating income (non-GAAP measure)

$

3,450

29.2

%

$

3,510

35.4

%

Reconciliation of adjusted net income

GAAP net income attributable to Thermo Fisher Scientific Inc.

$

2,215

$

2,337

Cost of revenues adjustments (a)

11

8

Selling, general and administrative expenses adjustments (b)

7

16

Restructuring and other costs (c)

2

14

Amortization of acquisition-related intangible assets

609

423

Other income/expense adjustments (d)

167

197

Provision for income taxes adjustments (e)

(169

)

(130

)

Equity in earnings/losses of unconsolidated entities

19

Adjusted net income (non-GAAP measure)

$

2,861

$

2,865

Reconciliation of adjusted earnings per share

GAAP diluted EPS attributable to Thermo Fisher Scientific Inc.

$

5.61

$

5.88

Cost of revenues adjustments (a)

0.03

0.02

Selling, general and administrative expenses adjustments (b)

0.02

0.04

Restructuring and other costs (c)

0.01

0.04

Amortization of acquisition-related intangible assets

1.54

1.06

Other income/expense adjustments (d)

0.42

0.50

Provision for income taxes adjustments (e)

(0.43

)

(0.33

)

Equity in earnings/losses of unconsolidated entities

0.05

0.00

Adjusted EPS (non-GAAP measure)

$

7.25

$

7.21

Reconciliation of free cash flow

GAAP net cash provided by operating activities

$

2,202

$

1,978

Purchases of property, plant and equipment

(640

)

(628

)

Proceeds from sale of property, plant and equipment

2

5

Free cash flow (non-GAAP measure)

$

1,564

$

1,355

Segment data

Three months ended

April 2,

% of

April 3,

% of

(In millions)

2022

Revenues

2021

Revenues

Revenues

Life Sciences Solutions

$

4,231

35.8

%

$

4,203

42.4

%

Analytical Instruments

1,518

12.8

%

1,387

14.0

%

Specialty Diagnostics

1,482

12.5

%

1,615

16.3

%

Laboratory Products and Biopharma Services

5,442

46.0

%

3,597

36.3

%

Eliminations

(855

)

-7.1

%

(896

)

-9.0

%

Consolidated revenues

$

11,818

100.0

%

$

9,906

100.0

%

Operating income and operating margin

Life Sciences Solutions

$

2,176

51.4

%

$

2,279

54.2

%

Analytical Instruments

301

19.8

%

272

19.6

%

Specialty Diagnostics

353

23.9

%

428

26.5

%

Laboratory Products and Biopharma Services

620

11.4

%

531

14.8

%

Subtotal reportable segments

3,450

29.2

%

3,510

35.4

%

Cost of revenues adjustments (a)

(11

)

-0.1

%

(8

)

-0.1

%

Selling, general and administrative expenses adjustments (b)

(7

)

0.0

%

(16

)

-0.1

%

Restructuring and other costs (c)

(2

)

0.0

%

(14

)

-0.1

%

Amortization of acquisition-related intangible assets

(609

)

-5.2

%

(423

)

-4.3

%

GAAP operating income

$

2,821

23.9

%

$

3,049

30.8

%

(a) Adjusted results in 2022 and 2021 exclude charges for the sale of inventories revalued at the date of acquisition.

(b) Adjusted results in 2022 and 2021 exclude certain third-party expenses, principally transaction/integration costs related to recent acquisitions and charges/credits for changes in estimates of contingent acquisition consideration.

(c) Adjusted results in 2022 and 2021 exclude restructuring and other costs consisting principally of severance, abandoned facility and other expenses of headcount reductions within several businesses and real estate consolidations. Adjusted results in 2021 also exclude $13 of charges for compensation due to employees at recently acquired businesses at the date of acquisition.

(d) Adjusted results in 2022 and 2021 exclude net gains/losses on investments and losses on the early extinguishment of debt.

(e) Adjusted provision for income taxes in 2022 and 2021 excludes incremental tax impacts for the pre-tax reconciling items between GAAP and adjusted net income and incremental tax impacts as a result of tax rate changes.

Note:

Consolidated depreciation expense is $250 and $198 in 2022 and 2021, respectively.

Organic and Core organic revenue growth

Three months ended

April 2, 2022

Revenue growth

19 %

Acquisitions

18 %

Currency translation

-2 %

Organic revenue growth

3 %

COVID-19 testing revenue

-12 %

Contribution of PPD to Core organic revenue growth (a)

1 %

Core organic revenue growth

16 %

(a) Adjustment to include the contribution of PPD to Core organic revenue growth as though the acquisition had occurred on January 1, 2021.

Note:

For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release.

Condensed Consolidated Balance Sheet (unaudited)

April 2,

December 31,

(In millions)

2022

2021

Assets

Current assets:

Cash and cash equivalents

$

2,752

$

4,477

Accounts receivable, net

7,889

7,977

Inventories

5,483

5,051

Other current assets

2,652

2,608

Total current assets

18,776

20,113

Property, plant and equipment, net

8,448

8,333

Acquisition-related intangible assets, net

19,378

20,113

Other assets

4,424

4,640

Goodwill

41,721

41,924

Total assets

$

92,747

$

95,123

Liabilities, redeemable noncontrolling interest and equity

Current liabilities:

Short-term obligations and current maturities of long-term obligations

$

1,866

$

2,537

Other current liabilities

10,204

10,899

Total current liabilities

12,070

13,436

Other long-term liabilities

8,157

8,377

Long-term obligations

31,389

32,333

Redeemable noncontrolling interest

113

122

Total equity

41,018

40,855

Total liabilities, redeemable noncontrolling interest and equity

$

92,747

$

95,123

Condensed Consolidated Statement of Cash Flows (unaudited)

Three months ended

April 2,

April 3,

(In millions)

2022

2021

Operating activities

Net income

$

2,220

$

2,337

Adjustments to reconcile net income to net cash provided by operating activities:

Depreciation and amortization

859

621

Change in deferred income taxes

(339

)

24

Other non-cash expenses, net

337

317

Changes in assets and liabilities, excluding the effects of acquisitions

(875

)

(1,321

)

Net cash provided by operating activities

2,202

1,978

Investing activities

Acquisitions, net of cash acquired

(40

)

(1,343

)

Purchases of property, plant and equipment

(640

)

(628

)

Proceeds from sale of property, plant and equipment

2

5

Other investing activities, net

8

(32

)

Net cash used in investing activities

(670

)

(1,998

)

Financing activities

Repayment of debt

(375

)

(2,803

)

Net proceeds from issuance of commercial paper

626

Repayment of commercial paper

(1,259

)

Purchases of company common stock

(2,000

)

(2,000

)

Dividends paid

(103

)

(87

)

Net proceeds from issuance of company common stock under employee stock plans

2

20

Other financing activities, net

(36

)

20

Net cash used in financing activities

(3,145

)

(4,850

)

Exchange rate effect on cash

(99

)

137

Decrease in cash, cash equivalents and restricted cash

(1,712

)

(4,733

)

Cash, cash equivalents and restricted cash at beginning of period

4,491

10,336

Cash, cash equivalents and restricted cash at end of period

$

2,779

$

5,603

Free cash flow (non-GAAP measure)

$

1,564

$

1,355

Notes:

For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release.

Supplemental Information Regarding Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures such as organic revenue growth, which is reported revenue growth, excluding the impacts of revenues from acquired businesses and the effects of currency translation. We also report Core organic revenue growth, which is reported revenue growth including the impact of PPD revenue, excluding the impacts of COVID-19 testing revenue, and excluding the impacts of acquisitions other than PPD and currency translation. We calculate period-to-period Core organic revenue growth by adding to the baseline period PPD's pre-acquisition revenues from such period. We report these measures because Thermo Fisher management believes that in order to understand the company's short-term and long-term financial trends, investors may wish to consider the impact of acquisitions, foreign currency translation and/or COVID-19 testing on revenues. In particular, given PPD's significance relative to our existing businesses, management believes it is appropriate to also present information on a basis that includes PPD pre-acquisition revenues in order to demonstrate the impact PPD has on our current growth profile. Core organic revenue growth amounts are not necessarily indicative of the combined results of operations that would have been realized had the PPD acquisition occurred on January 1, 2021. Thermo Fisher management uses these measures to forecast and evaluate the operational performance of the company as well as to compare revenues of current periods to prior periods.

We report adjusted operating income, adjusted operating income margin, adjusted net income, and adjusted EPS. We believe that the use of these non-GAAP financial measures, in addition to GAAP financial measures, helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company's core operating performance, especially when comparing such results to previous periods, forecasts, and to the performance of our competitors. Such measures are also used by management in their financial and operating decision-making and for compensation purposes. To calculate these measures we exclude, as applicable:

  • Certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition, significant transaction/acquisition-related costs, including changes in estimates of contingent acquisition-related consideration, and other costs associated with obtaining short-term financing commitments for pending/recent acquisitions. We exclude these costs because we do not believe they are indicative of our normal operating costs.
  • Costs/income associated with restructuring activities, such as reducing overhead and consolidating facilities. We exclude these costs because we believe that the costs related to restructuring activities are not indicative of our normal operating costs.
  • Equity in earnings/losses of unconsolidated entities; impairments of long-lived assets; and certain other gains and losses that are either isolated or cannot be expected to occur again with any predictability, including gains/losses on investments, the sale of businesses, product lines, and real estate, significant litigation-related matters, curtailments/settlements of pension plans, and the early retirement of debt. We exclude these items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods.
  • The expense associated with the amortization of acquisition-related intangible assets because a significant portion of the purchase price for acquisitions may be allocated to intangible assets that have lives of up to 20 years. Exclusion of the amortization expense allows comparisons of operating results that are consistent over time for both our newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies.
  • The tax impacts of the above items and the impact of significant tax audits or events (such as changes in deferred taxes from enacted tax rate changes), the latter of which we exclude because they are outside of our normal operations and difficult to forecast accurately for future periods.

We report free cash flow, which is operating cash flow, excluding net capital expenditures to provide a view of the continuing operations' ability to generate cash for use in acquisitions and other investing and financing activities. The company also uses this measure as an indication of the strength of the company. Free cash flow is not a measure of cash available for discretionary expenditures since we have certain non-discretionary obligations such as debt service that are not deducted from the measure.

Thermo Fisher Scientific does not provide GAAP financial measures on a forward-looking basis because we are unable to predict with reasonable certainty and without unreasonable effort items such as the timing and amount of future restructuring actions and acquisition-related charges as well as gains or losses from sales of real estate and businesses, the early retirement of debt and the outcome of legal proceedings. The timing and amount of these items are uncertain and could be material to Thermo Fisher Scientific's results computed in accordance with GAAP.

The non-GAAP financial measures of Thermo Fisher Scientific's results of operations and cash flows included in this press release are not meant to be considered superior to or a substitute for Thermo Fisher Scientific's results of operations prepared in accordance with GAAP. Reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measures are set forth in the tables above.

Media Contact Information:
Ron O'Brien
Thermo Fisher Scientific
Phone: 781-622-1242
E-mail: ron.obrien@thermofisher.com

Investor Contact Information:
Rafael Tejada
Thermo Fisher Scientific
Phone: 781-622-1356
E-mail: rafael.tejada@thermofisher.com

News Provided by Business Wire via QuoteMedia

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Valens GroWorks (CSE:VGW)(CSE:VGW.CN) (the “Company” or “Valens“) and its wholly-owned subsidiary Supra THC Services Inc. (“Supra“) are pleased to announce a collaboration between Supra and Thermo Fisher Scientific (Mississauga) Inc. to develop a “Centre of Excellence in Plant Based Medicine Analytics” centered in Kelowna, British Columbia. This agreement is the first of its kind between a Canadian cannabis company and a world leader in Health Science services, with an ability to deliver innovative technologies, purchasing convenience and comprehensive services to this emerging market.
Supra’s operations are located in the Company’s state-of-the-art 17,000 sq ft Kelowna facility, currently undergoing modifications ahead of a significant expansion. Supra will utilize a suite of Thermo Fisher Scientific sector-leading advanced analytical instrumentation to provide analytical services, research and development, forensic analysis and support for clinical trials as well as being a demonstration and training site for Thermo Fisher Scientific clients and third parties involved in this rapidly evolving sector. It will also be used as a regional resource center for universities and companies.
Dr. Rob O’Brien, CEO and Chief Science Officer of Supra THC Services Inc. stated; “There are many plants such as Cannabis that contain active ingredients which could be effective treatments for disease or provide critical health improvements. However, conducting proper clinical trials with materials that contain many active ingredients is challenging, particularly if the effective absorbed dose can vary significantly depending on how the material is consumed. For example, the effectiveness of absorption of active ingredients contained in an oil carrier is much different if that oil is placed under the patients tongue, then if the oil, or edible, is swallowedTo measure the amount of active ingredients and metabolites in blood, urine, hair and saliva, advanced instrumentation and a team of highly qualified personal is essential. With the Supra THC Services team and advanced instrumentation from Thermo Fisher Scientific, many significant advances are expected.”
Luc Dionne, Canadian Sales Manager with Thermo Fisher Scientific (Mississauga) Inc., states We welcome the opportunity to work with Dr. Rob O’Brien and the Supra THC Services team, an organization that conducts testing activities in plant based medicine. Dr. O’Brien has an extensive background in analytical chemistry and is a recognized authority in scientific circles. Dr. O’Brien has worked closely with Thermo Fisher Scientific in the past using several of our market leading technologies to successfully perform testing on natural products, pharmaceutical formulations and environmental samples. We are delighted that his team has selected Thermo Fisher Scientific‘s cost effective analytical testing solutions to promote the advancement of testing protocols to meet the rigorous and regulatory requirements of this market segment.
About Valens GroWorks Corp.
Valens GroWorks Corp. is a CSE-listed company with an aggressive buildout strategy in progress. The Company seeks to capture a broad spectrum of medical cannabis users and adult recreational users once legalized, as well as clinical trial and R&D clients, in pursuit of its ambitious seed-to-sale and farm-to-pharma objectives. The Company also provides management, consulting, testing and support services to domestic and international licensees, as well as financing and managing buildouts of fully-licensed 3rd party operations.
The Company has two wholly-owned subsidiaries based in the Okanagan Valley of British Columbia: 1) Valens Agritech Ltd. (“VAL”) which holds a Health Canada Dealer’s License, and 2) Supra THC Services Inc., a Health Canada licensed cannabis testing lab providing sector-leading analytical and proprietary services to Licensed Producers and ACMPR patients. For more information, please visit http:/valensgroworks.comhttp://www.valensagritech.com and http://www.suprathc.ca.
About Thermo Fisher Scientific (Mississauga) Inc.
Thermo Fisher Scientific (Mississauga) Inc. is a wholly owned subsidiary of Thermo Fisher Scientific Inc. (NYSE: TMO) the world leader in serving science, with revenues of more than US$20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands — Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services — we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. For more information, please visit www.thermofisher.com.
On behalf of the Board of Directors,
VALENS GROWORKS CORP.
(signed) Tyler Robson
Chief Executive Officer
For further information, please contact:
Greg Patchell
Telephone: +1.250.860.8634
Notice regarding Forward Looking Statements
This news release contains certain “forward-looking statements” within the meaning of such statements under applicable securities law. Forward-looking statements are frequently characterized by words such as “plan”, “continue”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Various assumptions were used in drawing the conclusions or making the projections contained in the forward-looking statements throughout this news release. Forward-looking statements are based on the opinions and estimates of management at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. The Corporation is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable law.
The CSE or other regulatory authority has not reviewed, approved or disapproved the contents of this press release. We seek Safe Harbour.
Click here to connect with Valens GroWorks (CSNX:VGW) to receive an Investor Presentation.

Thermo Fisher Scientific Expands Global Footprint to Support Cell and Gene Therapy Clinical Trials in Japan

To help meet increasing demand for cell and gene therapy clinical trial support around the globe, Thermo Fisher Scientific, the world leader in serving science, today announced the expansion of its Fisher BioServices cryogenic service capabilities in Japan.
This expansion enables its customers to seamlessly conduct clinical trials across multiple
geographies and provides patients around the world with access to life
changing therapies. As a leading service provider to the cell and gene
therapy community, Fisher BioServices is uniquely positioned with the
experience, resources, and global expertise to support its customers on
their path towards commercialization.
The facility in Tokyo was expanded to include cryogenic storage and
logistics by utilizing a combination of proven components and validated
procedures developed with years of experience in the cell and gene
therapy business. The new modules within this facility allow Fisher
BioServices to configure and replicate each site to meet the specific
requirements of individual clinical trials with minimal variation,
regardless of volume or geographic location. The facility is also
supported by a global comprehensive and integrated Quality System based
on regulatory requirements, industry best practices and trained
personnel.
“Japan is an increasingly important market for cell and gene therapy
companies conducting clinical trials,” said Dennis Barger, Fisher
BioServices vice president and general manager. “The addition of
cryogenic services to this facility in Japan, combined with our existing
capabilities in Europe and the US, enables us to seamlessly support our
customers’ global trials as they develop and commercialize their
therapies.”
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc.
(NYSE: TMO) is the world leader in serving science, with revenues of $17
billion and more than 50,000 employees in 50 countries. Our mission is
to enable our customers to make the world healthier, cleaner and safer.
We help our customers accelerate life sciences research, solve complex
analytical challenges, improve patient diagnostics and increase
laboratory productivity. Through our premier brands – Thermo Scientific,
Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services
– we offer an unmatched combination of innovative technologies,
purchasing convenience and comprehensive support. For more information,
please visit www.thermofisher.com.

Abbott Enters into Consent Decree with U.S. Food and Drug Administration for its Sturgis, Mich., Plant; Agreement Creates Pathway to Reopen Facility

  • After FDA approval, Abbott could restart the site within two weeks; from the time of restart it would take six to eight weeks before product is available on shelves
  • Abbott will continue to import formula from FDA-registered facility in Ireland to help alleviate near-term supply shortage
  • CDC concluded its investigation with no findings of a link between Abbott formulas and infant illnesses

Abbott (NYSE: ABT) has agreed to enter into a consent decree with the U.S. Food and Drug Administration (FDA) related to its Sturgis, Mich. infant formula plant. The decree is an agreement between FDA and Abbott on the steps necessary to resume production and maintain the facility. This does not affect any other Abbott plant or operation. The decree is subject to court approval.

"Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely re-open the facility," said Robert B. Ford , chairman and chief executive officer, Abbott. "We know millions of parents and caregivers depend on us and we're deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years."

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Viemed Provides Update Concerning Successful Appeal of Office of Inspector General Findings

Viemed Healthcare, Inc. (the " Company " or " Viemed ") (NASDAQ:VMD and TSX:VMD.TO), a home medical equipment supplier and the nation's largest independent provider of ventilation that provides post-acute respiratory care services, is providing an update concerning the Company's appeal of claims related to findings from the U.S. Department of Health and Human Services Office of Inspector General ("OIG") in a May 2021 report ("Report"). Based on an objective and independent review of patients' medical records, the Centers for Medicare and Medicaid Services' ("CMS") Qualified Independent Contractor ("QIC") responsible for evaluating the Company's Reconsideration appeals determined that approximately 77% of the claims it reviewed were medically necessary and properly payable under Medicare rules and regulations, overturning OIG's and CMS's initial recommendations and determinations.

"The success of our latest round of appeals is an extremely positive development for patients and their families who depend on payors to hold up their end of the health care delivery network," said Casey Hoyt, Viemed's CEO. "We wholeheartedly believe in protecting and advancing the rights of these patients to have access to the care prescribed by qualified licensed physicians. As a leader in the respiratory care industry, we will continue to support responsible rulemaking and other initiatives to ensure that the best care remains available to those in need."

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Applied UV Announces Order for The Renaissance Cleveland Hotel

Applied UV Announces Order for The Renaissance Cleveland Hotel

$2M Furnishings Order Expected Subject to Initial "Model Room" Product Approval

Applied UV, Inc. (NasdaqCM: AUVI ) ("Applied UV" or the "Company"), a pathogen elimination technology company that applies the power of narrow-range ultraviolet light ("UVC") for surface areas and catalytic bioconversion technology for air purification to destroy pathogens safely, thoroughly, and automatically, announces that its wholly owned subsidiary MunnWorks, a custom manufacturer of luxury mirrors and furniture for the hospitality market, has received a model room order from The Renaissance Cleveland Hotel , which will be fully funded by the developer of the hotel. Upon successful acceptance of the "Model Room" order, a follow-on $2M order is expected. This order for hotel furniture will be manufactured in MunnWorks 100,000 square foot Brooklyn, NY manufacturing facility, which MunnWorks acquired on March 31 st , 2022, through the purchase of VisionMark LLC's luxury furniture manufacturing business.

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Medtronic receives FDA approval for latest generation drug-eluting coronary stent system

The Onyx Frontier™ drug-eluting stent offers an innovative delivery system and builds upon the acute performance and clinical data from the Resolute Onyx™ drug-eluting stent

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received U.S. Food and Drug Administration (FDA) approval for the Onyx Frontier™ drug-eluting stent (DES). As the latest evolution in the Resolute DES family, Onyx Frontier DES leverages the same best-in-class stent platform as Resolute Onyx™ DES, with an enhanced delivery system 1 designed to improve deliverability and increase acute performance 2 in even the most challenging of cases. 1

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Medtronic completes acquisition of Intersect ENT

Acquisition adds innovative bioabsorbable steroid-eluting sinus implants to ENT portfolio

- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that it has completed the acquisition of Intersect ENT, expanding the company's comprehensive ear, nose, and throat (ENT) portfolio with innovative products used in sinus procedures to improve post-operative outcomes and to treat nasal polyps.

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Danaher Joins Bespoke Gene Therapy Consortium for Rare Diseases

Consortium aims to speed the development and delivery of customized or 'bespoke' gene therapies

Danaher Corporation (NYSE: DHR) announced that it has joined the Bespoke Gene Therapy Consortium (BGTC). Launched in October 2021 the BGTC will generate gene therapy resources that the research community can use to streamline gene therapy development for rare disorders, making the process more efficient and less costly. Danaher's Life Science companies join the Food and Drug Administration (FDA), the National Institutes of Health (NIH), twelve pharmaceutical and biotech companies and nine non-profits, and will be represented by experts from Danaher Corporation and its companies, notably Pall Corporation, Aldevron and Cytiva. The project is managed by the Foundation for the National Institutes of Health (FNIH) as part of the Accelerating Medicines Partnership® program.

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