On October 21, 2020 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the third quarter ended September 26, 2020 (Press release, Thermo Fisher Scientific, OCT 21, 2020, View Source [SID1234568719]).

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Third Quarter 2020 Highlights

Third quarter revenue increased 36% to $8.52 billion.
Third quarter GAAP diluted earnings per share (EPS) increased 157% to $4.84.
Third quarter adjusted EPS increased 91% to $5.63.

Generated $2.0 billion of COVID-19 related revenue in the quarter and returned the base business to growth.

Further expanded our global pandemic response, including launching the Amplitude Solution to automate high-throughput PCR-based testing, adding significant capacity for viral transport media production in Europe and introducing two new COVID-19 antibody tests that are available in the U.S. and Europe.

Continued to increase our capacity to help governments and biopharma customers globally meet future demand for new therapies and vaccines, most recently partnering with the Economic Development Board of Singapore to build our first pharma services facility there, which will include the only high-speed live virus filling line in Singapore.

Launched the Just Project to benefit historically black colleges and universities by donating more than $25 million of COVID-19 diagnostic test kits, instruments, supplies and technical assistance to enable the safe return of students and staff, and also established a $20 million Foundation for Science supporting STEM education in underserved communities.

Expanded our well-established center of excellence in Suzhou, China, by opening a new bioproduction factory for manufacturing single-use technologies to meet demand for biologics in the Asia-Pacific region.

Launched innovative Thermo Scientific products across our businesses, highlighted by two Selectris imaging filters for cryo-electron microscopes that accelerate research in structural analysis of proteins, and the POROS Oligo (dT)25 Affinity Resin to advance mRNA-based therapies and vaccines.
Adjusted EPS, adjusted operating income, adjusted operating margin and free cash flow are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of Non-GAAP Financial Measures."

"We further accelerated our exceptional growth momentum in the third quarter," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "Our teams executed very well to build on our leadership in supporting the global pandemic response and also captured opportunities to grow our base business.

"We’ve continued to meet COVID-related customer demand by launching new products across our company, such as tests and automated workflows to accurately diagnose the virus and enable society’s return to work and school. At the same time, we’re adding new capabilities, including scaling up production of sample collection products and essential laboratory supplies as well as increasing our pharma services capacity to support new therapies and vaccines. The combination of all these activities is creating a strong foundation for future growth."

Casper added, "The past nine months have been nothing short of incredible for our company, and I’m truly humbled by our colleagues around the world who are making a meaningful and positive impact on society through their work. We’re on track to deliver a record year, and importantly, positioning our company for an even brighter future."

Third Quarter 2020

Revenue for the quarter grew 36% to $8.52 billion in 2020, versus $6.27 billion in 2019. Organic revenue growth was 34%, currency translation increased revenue by 1% and acquisitions increased revenue by 1%.

GAAP Earnings Results

GAAP diluted EPS in the third quarter of 2020 increased 157% to $4.84, versus $1.88 in the same quarter last year. GAAP operating income for the third quarter of 2020 increased to $2.43 billion, compared with $0.95 billion in the year-ago quarter. GAAP operating margin increased to 28.5%, compared with 15.1% in the third quarter of 2019.

Non-GAAP Earnings Results

Adjusted EPS in the third quarter of 2020 increased 91% to $5.63, versus $2.94 in the third quarter of 2019. Adjusted operating income for the third quarter of 2020 grew 97% compared with the year-ago quarter. Adjusted operating margin increased to 32.9%, compared with 22.7% in the third quarter of 2019.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the company’s four business segments, as highlighted below. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

Life Sciences Solutions Segment

In the third quarter of 2020, Life Sciences Solutions Segment revenue grew to $3.42 billion, compared with revenue of $1.70 billion in the third quarter of 2019. Segment adjusted operating margin increased to 54.9%, versus 34.5% in the 2019 quarter.

Analytical Instruments Segment

Analytical Instruments Segment revenue was $1.34 billion in the third quarter of 2020, compared with revenue of $1.36 billion in the third quarter of 2019. Segment adjusted operating margin was 12.8%, versus 23.0% in the 2019 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue grew to $1.43 billion in the third quarter of 2020, compared with revenue of $0.88 billion in the third quarter of 2019. Segment adjusted operating margin increased to 27.9%, versus 25.3% in the 2019 quarter.

Laboratory Products and Services Segment

In the third quarter of 2020, Laboratory Products and Services Segment revenue increased to $3.11 billion, compared with revenue of $2.62 billion in the third quarter of 2019. Segment adjusted operating margin was 11.4%, versus 11.6% in the 2019 quarter.

Use of 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, including adjusted EPS, adjusted operating income and adjusted operating margin, which exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs; restructuring and other costs/income; and amortization of acquisition-related intangible assets. Adjusted EPS also excludes certain other gains and losses that are either isolated or cannot be expected to occur again with any predictability, tax provisions/benefits related to the previous items, and the impact of significant tax audits or events. We exclude the above items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. We also use a non-GAAP measure, 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. We believe that the use of non-GAAP 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 performance, especially when comparing such results to previous periods or forecasts.

For example:

We exclude costs and tax effects associated with restructuring activities, such as reducing overhead and consolidating facilities. We believe that the costs related to these restructuring activities are not indicative of our normal operating costs.

We exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs. We exclude these costs because we do not believe they are indicative of our normal operating costs.

We exclude the expense and tax effects 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 3 to 20 years. Based on acquisitions closed through the end of the third quarter of 2020, adjusted EPS for full-year 2020 will exclude approximately $3.25 of expense for the amortization of acquisition-related intangible assets. 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.

We also exclude certain gains/losses and related tax effects, the impact of significant tax audits or events (such as changes in deferred taxes from enacted tax rate changes or the estimated initial impacts of U.S. tax reform legislation), which are either isolated or cannot be expected to occur again with any predictability and that we believe are not indicative of our normal operating gains and losses. For example, we exclude gains/losses from items such as the sale of a business or real estate, gains or losses on significant litigation-related matters, gains on curtailments of pension plans and the early retirement of debt.

We also 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.

Thermo Fisher’s management uses these non-GAAP measures, in addition to GAAP financial measures, as the basis for measuring the company’s core operating performance and comparing such performance to that of prior periods 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.

The non-GAAP financial measures of Thermo Fisher’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’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 accompanying tables. Thermo Fisher 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’s results computed in accordance with GAAP.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, October 21, 2020, at 8:30 a.m. Eastern time. To listen, dial (833) 714-0931 within the U.S. or (778) 560-2662 outside the U.S. The passcode is 1570827. 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 "Financial Results." An audio archive of the call will be available under "Webcasts and Presentations" through Friday, November 6, 2020.

On October 21, 2020 ERYTECH Pharma (Euronext Paris : ERYP – Nasdaq : ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances in red blood cells (the "Company"), reported the implementation of an at-the-market program allowing the Company to issue and sell ordinary shares in the form of American Depositary Shares ("ADSs"), to eligible investors at market prices, with aggregate gross sales proceeds of up to $30,000,000 (subject to a regulatory limit of 20% dilution), from time to time, pursuant to the terms of a sales agreement with Cowen acting as sales agent (Press release, ERYtech Pharma, OCT 21, 2020, View Source [SID1234568715]).

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The ATM program will allow the Company to issue ordinary shares in the form of ADSs, each representing one ordinary share of the Company, that may be sold through Cowen, at the Company’s discretion and instruction, at prevailing market prices on Nasdaq from time to time, without shareholders’ preferential subscription rights, for an aggregate offering amount of up to $30 million, being specified that the maximum number of new shares to be admitted on the regulated market of Euronext Paris is capped at 20% of the number of shares admitted to trading on such market, including shares admitted without prospectus during the last twelve months at the date of their issuance. Only eligible investors (as described in greater detail below) may purchase ADSs under the ATM program. The ATM program will be effective until September 21, 2023, unless terminated prior to such date in accordance with the sales agreement or the maximum number of ADSs to be sold thereunder has been reached.

The establishment of this financing facility follows the resolutions adopted at the Company’s Annual General Meeting of Shareholders on June 26, 2020. A new shelf registration statement on Form F-3 was filed by the Company with the U.S. Securities and Exchange Commission on September 21, 2020 to roll over the Company’s previously filed shelf registration and to cover the ATM program, but has not yet become effective.

The ADSs and the ordinary shares will be issued through a capital increase without shareholders’ preferential subscription rights under the provisions of Article L. 225-138 of the French Commercial Code (Code de commerce) and pursuant to the 25th resolution adopted by the Annual General Meeting of Shareholders held on June 26, 2020. The new ordinary shares to be sold in the form of ADSs would be issued in one or more offerings at market prices of the ADSs at the time of pricing of the considered capital increase.

The ATM program may only be issued to the categories of investors defined in the 25th resolution described above including natural or legal persons, including companies, trusts or investment funds or other investment vehicles whatever their form, governed by French or foreign law and investing on a regular basis in the pharmaceutical, biotechnological or medical technology sectors and/or companies, institutions or entities, whatever their form, governed by French or foreign law, that carry out a significant part of their activities in the pharmaceutical, cosmetic or chemical sectors or in medical devices and/or technology or in research in these sectors. The new ordinary shares will be admitted to trading on the regulated market of Euronext Paris and the issued ADSs will trade on Nasdaq.

The Company expects to use the net proceeds from sales of any ADSs and ordinary shares issued under the ATM program primarily to fund the research and development of its product candidates, and for working capital and general corporate purposes.

On an illustrative basis, assuming the issue of 4,016,064 ADSs at a price of $7.47 (or €6.331) the last reported sale price of the ADSs on Nasdaq on September 17, 2020, for the maximum gross proceeds of $30,000,000 (or €25,430,194 2), a holder of 1% of the outstanding Company’s share capital as of the date of this press release, would hold 0.83% of the outstanding Company’s share capital after the completion of the transaction (calculated on the basis of the number of outstanding shares on the date of publication of this press release).

During the term of the ATM program, the Company will publish a quarterly communication as part of the publication of its quarterly results, as well as an update after each capital increase on a dedicated location on its corporate website in order to inform investors about the main features of each issue that may be completed under the ATM program from time to time.

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. When available, copies of the prospectus supplement and the accompanying prospectus relating to these securities may be obtained from Cowen, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926. No prospectus will be subject to the approbation of the Autorité des Marchés Financiers ("AMF").

This press release does not constitute an offer to sell or a solicitation to buy the securities mentioned and no sale of such securities will be made in any state or province in which such offer, solicitation or sale would be unlawful until the securities are registered or their distribution is permitted under the securities laws of that state or province.

Information available to the public

No prospectus will be filed with the AMF. Detailed information concerning the Company, in particular with regard to its business, results, forecasts and corresponding risk factors, is provided in (i)] the Company’s 2019 universal registration document, filed with the AMF on March 19, 2020 and under number D. 20-0140[, and (ii) the 2020 half-year financial report published on September 21, 2020. These documents, as well as other regulated information and all of the Company’s press releases, are available on its website and on the AMF website (www.amf-france.org) and are available free of charge on request at the Company’s registered office at 60 Avenue Rockefeller, Bâtiment Adénine – 69008 Lyon, France.

On October 21, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has entered into a license agreement for worldwide non-exclusive rights of several Chugai’s antibody engineering technologies with Novo Nordisk A/S (Press release, Chugai, OCT 21, 2020, View Source [SID1234568712]).

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Under the terms of agreement, Novo Nordisk will receive the rights to use several Chugai’s antibody engineering technologies for their research activities and optional rights for the development and marketing of therapeutic antibodies applying those technologies. In return for the license, Chugai will receive a fee for technology access. In case Novo Nordisk creates a candidate antibody and exercises optional rights, Chugai will receive an upfront payment, milestone payments according to the development status, and royalty payment if the compound is launched as an approved antibody drug.

"Antibody engineering technology is one of Chugai’s core competencies and has led to the creation of innovative antibody drugs," said Dr. Junichi Nezu, Chugai’s Vice President, Head of Research Division. "We have high hopes that Novo Nordisk will utilize Chugai’s proprietary antibody engineering technologies to solve unmet medical needs and create novel medicines."

"With this agreement we have secured long-term access to antibody engineering technologies from Chugai which is one of the world leading companies within this field" added Lars Fogh Iversen, Senior Vice President, Global Research Technologies, Novo Nordisk. "Novo Nordisk is committed to protein-based therapeutics and access to premier technologies is essential to advancing the highest quality therapeutic programs."

On October 20, 2020 Xspray Pharma reported the company has based on the authorisation granted by the annual general meeting on 14 May 2020, and in accordance with that the Company indicated in a press release on 20 October 2020, successfully carried out a directed share issue at a subscription price of SEK 142.50 per share (the "Issue") (Press release, Xspray, OCT 20, 2020, View Source [SID1234650115]). The subscription price has been determined through an accelerated bookbuild transaction.

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A number of Swedish and international institutional investors, including Tredje AP-fonden, Handelsbanken Fonder, Andra AP-fonden, Swedbank Robur Fonder, Fjärde AP-fonden and TIN Ny Teknik have subscribed for shares in the Issue. The Company believes that using the flexibility provided by a non-pre-emptive placing is the most appropriate transaction structure in order to raise capital in a time- and cost-effective manner, whilst also further diversifying and strengthening the Company’s shareholder base.

The Company intends to use the net proceeds from the Issue to:

Enhance the Company’s financial position ahead of negotiating a deal pertaining to its lead product, HyNap-Dasa
Continue to expand the product portfolio
Complete the construction of its new manufacturing facility at a CMO in Malta
General corporate purposes
"The interest in Xspray is extremely motivating and we would like to thank the investors for their confidence in Xspray and our R&D. With the additional capital, we now have the financial strength required for our business development negotiations with potential partners for our most advanced project HyNap-Dasa. It will also allow us to speed up development of the next-in-line product candidates in our pipeline. We plan to start the study program with HyNap-Nilo already in Q1 2021 and to bring the exciting but not yet communicated subsequent product candidates forward in development. Furthermore, we are now able to finalize the expansion of our production capability in Malta allowing us to work at full speed with several products simultaneously," says Per Andersson, CEO Xspray Pharma.

The Issue is expected to raise proceeds for the Company of SEK 265 million, before transaction costs. The Issue will result in an increase in the number of shares in Xspray of 1,861,291, from 17,031,213 to 18,892,504, and an increase in the share capital by SEK 1,861,291 from SEK 17,031,213 to 18,892,504 resulting in a dilution of approximately 10%.

In connection with the Issue, the Company has agreed to a lock-up undertaking on future share issuance for a period of 90 days, subject to customary exceptions. In addition, the management and Board of Directors have undertaken not to sell any shares in Xspray during the same period subject to the right to sell shares to cover tax liabilities and to exercise holdings in the Company’s incentive program and customary exceptions.

Citigroup Global Markets Limited, Pareto Securities AB and Zonda Partners are acting as Joint Bookrunners in connection with the Issue. Vinge is acting as legal advisor to the Company and Baker McKenzie is acting as legal advisor to Citigroup Global Markets Limited, Pareto Securities AB and Zonda Partners.

On October 20, 2020 Chaperone, a new drug development bio venture, reported that it has completed attracting 26 billion won in Series C investment (Press release, Shaperon, OCT 20, 2020, View Source;idx=33&pNo=4&code=press_en [SID1234629322]).

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This investment includes follow-up investments from four existing investors, including Smilegate Investment, Yuanta Investment, and Seoul Investment Partners, as well as a total of nine investments, including POSCO Technology Investment, Moorim Capital, BNK Venture Investment, Albatros Investment, JX Partners, and Nova Healthcare. agency participated.

The amount by investor was 9 billion won by POSCO Technology Investment-Moorim Capital Investment Association and 7 billion won by Smilegate Investment, and other institutions were responsible for the rest.

With this investment as an opportunity, Chaperon is currently in phase 2 clinical trial for atopic dermatitis treatment in Korea and phase 2 clinical trial for COVID-19 treatment in Europe, as well as septicemia treatment that has completed phase 1 clinical trial and phase 1 clinical trial. It plans to accelerate the development and commercialization of Alzheimer’s dementia and ulcerative colitis treatments. In addition, the development of nanobody therapeutics, which are alpaca-derived fragment antibodies that overcome the limitations of existing antibodies, will also be accelerated.

To this end, Lee Myung-se, who recently served as CEO of Eli Lilly Philippines and Korea representative director of Abbott and Mundipharma, has been recruited as co-CEO, and co-CEO Seung-Yong Sung, the founder, is promoting global commercialization in the technology and business fields.

The NLRP3 inflammatory complex inhibitor being developed by Chaperon is a newly emerging target in new drug development to the extent that less than 10 bio companies around the world have substances that have entered the clinical stage, and multinational pharmaceutical companies are highly interested in it.

While competitive substances inhibit only IL-1β, Chaperone’s new drug substance simultaneously controls the initiation and amplification steps of the inflammatory complex, suppressing a wide range of inflammatory factors such as IL-1β, IL-6, and TNF-α, resulting in various inflammatory factors. It is more effective for acute chronic inflammatory diseases and shows the fastest clinical stage compared to competitors.

Co-CEO Lee Myung-se said, "With the goal of an IPO in 2021, we will materialize commercialization through global open innovation based on the world’s first GPCR receptor-modulating inflammatory complex inhibitor and nanobody platform technology established by only a handful of companies in the world."