O July 22, 2020 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the second quarter ended June 27, 2020 (Press release, Thermo Fisher Scientific, JUL 22, 2020, View Source [SID1234562245]).

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Second Quarter 2020 Highlights

•Second quarter revenue increased 10% to $6.92 billion.
•Second quarter GAAP diluted earnings per share (EPS) increased 5% to $2.90.
•Second quarter adjusted EPS increased 28% to $3.89.

•Leveraged our industry-leading scale and expertise to meet strong global demand for COVID-19 products and services. Highlights in the second quarter included:
–Generated approximately $1.3 billion of COVID-related revenue
–Received expansion of emergency use authorization (EUA) to run our PCR test on additional instruments and consumables for greater workflow flexibility
–Designed and built a new facility in Lenexa, Kansas, to manufacture highly specialized viral transport media (VTM) for sample collection under a U.S. government contract
–Formed a collaboration with WuXi Diagnostics and Mayo Clinic to develop a total antibodies serology test
–Secured a multi-year pharma services contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to support accelerated vaccine development and production.

•Continued to increase our global pharma services capacity to meet strong customer demand, announcing a strategic partnership with CSL Limited to provide our entire portfolio of pharma services and operate their new biologics facility in Lengnau, Switzerland, and beginning construction of a new site in Plainville, Massachusetts, that will double our viral vector manufacturing capacity.

•Launched innovative products and services across our businesses, including two new-generation Exploris mass spectrometers that extend our Orbitrap platform, a digital service offering for increased remote instrument support and a cell culture medium that enhances bioproduction efficiency.

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 delivered an extraordinary quarter," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "We quickly mobilized our resources to support the global COVID-19 response and made a significant contribution to our customers and society while effectively managing the company through the current economic environment.

"Our teams worked with relentless intensity to establish Thermo Fisher as a global leader in COVID-19 testing and leverage our pharma services leadership to support the development and production of therapeutics and vaccines. At the same time, we continued to execute our growth strategy, developing new products and capabilities across our businesses that will position us well for years to come."

Casper added, "I’m very proud of what we’ve accomplished so far this year. Our performance demonstrates the strength of our company, the talent and sheer determination of our teams, and the scale of our role in helping customers and governments navigate these unprecedented times."

Second Quarter 2020

Revenue for the quarter grew 10% to $6.92 billion in 2020, versus $6.32 billion in 2019. Organic revenue growth was 11% and currency translation decreased revenue by 1%.

GAAP Earnings Results

GAAP diluted EPS in the second quarter of 2020 increased 5% to $2.90, versus $2.77 in the same quarter last year. GAAP operating income for the second quarter of 2020 was $1.39 billion, compared with $1.50 billion in the year-ago quarter. GAAP operating margin was 20.1%, compared with 23.7% in the second quarter of 2019. GAAP results for the second quarter of 2019 reflect a gain on the sale of the company’s Anatomical Pathology business in June 2019.

Non-GAAP Earnings Results

Adjusted EPS in the second quarter of 2020 increased 28% to $3.89, versus $3.04 in the second quarter of 2019. Adjusted operating income for the second quarter of 2020 grew 26% compared with the year-ago quarter. Adjusted operating margin increased to 27.0%, compared with 23.5% in the second 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 second quarter of 2020, Life Sciences Solutions Segment revenue was $2.60 billion, compared with revenue of $1.71 billion in the second quarter of 2019. Segment adjusted operating margin was 47.4%, versus 35.6% in the 2019 quarter.

Analytical Instruments Segment

Analytical Instruments Segment revenue was $1.05 billion in the second quarter of 2020, compared with revenue of $1.32 billion in the second quarter of 2019. Segment adjusted operating margin was 12.9%, versus 21.6% in the 2019 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue was $0.99 billion in the second quarter of 2020, compared with revenue of $0.94 billion in the second quarter of 2019. Segment adjusted operating margin was 21.6%, versus 25.7% in the 2019 quarter. The company sold its Anatomical Pathology business at the end of June 2019.

Laboratory Products and Services Segment

In the second quarter of 2020, Laboratory Products and Services Segment revenue was $2.79 billion, compared with revenue of $2.63 billion in the second quarter of 2019. Segment adjusted operating margin was 10.1%, versus 13.1% 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 second quarter of 2020, adjusted EPS for full-year 2020 will exclude approximately $3.23 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, July 22, 2020, at 8:30 a.m. Eastern time. To listen, dial (877) 273-7122 within the U.S. or (647) 689-5496 outside the U.S. 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, August 28, 2020.

On July 22, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported the pricing of an underwritten public offering of 20,000,000 shares of its common stock at a price to the public of $1.90 per share. CASI has granted the underwriters a 30-day option to purchase up to an additional 3,000,000 shares of its common stock (Press release, CASI Pharmaceuticals, JUL 22, 2020, View Source [SID1234562242]). The offering is expected to close on or about July 24, 2020, subject to satisfaction of customary closing conditions. The gross proceeds to CASI from the offering, excluding any exercise by the underwriters of their 30-day option to purchase additional shares, are expected to be approximately $38.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by CASI.

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Oppenheimer & Co. Inc. is acting as the sole bookrunning manager, and Brookline Capital Markets, a division of Arcadia Securities, LLC is acting as co-manager, for the offering.

CASI intends to use the net proceeds of the offering for working capital and general corporate purposes, which include, but are not limited to advancing our product portfolio, acquiring the rights to new product candidates and general and administrative expenses.

The securities described above are being offered by CASI pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed on December 13, 2017 and declared effective by the U.S. Securities and Exchange Commission ("SEC") on December 22, 2017. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, by telephone at (212) 667-8055, or by email at [email protected].

Before investing in the offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that CASI has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about CASI and the offering.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

On July 22, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the Phase Ib study of the company’s novel MDM2-p53 inhibitor candidate APG-115 as a single agent or in combinations for the treatment of Chinese patients with relapsed/refractory acute myeloid leukemia (r/r AML), or relapsed/progressed high/very high risk myelodysplastic syndrome (MDS) has dosed its first patient in China (Press release, Ascentage Pharma, JUL 22, 2020, View Source [SID1234562241]). As the first MDM2-p53 inhibitor entering clinical studies for the treatment of solid tumors in China, this is the first study of APG-115 in patients with hematologic malignancies.

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This multicenter Phase Ib clinical study in China is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of APG-115 as a single agent or in combination with azacitidine or cytarabine in patients with hematologic malignancies, including r/r AML and relapsed/progressed high/very high risk MDS.

AML is a clonal proliferative disease of the bone marrow, of which the incidence rate increases with age. AML is the most common type of leukemia in China, with an incidence rate of 1.62-2.32 cases per 100,0001. The standard induction therapy for AML comprises the "7+3" regimen (7 days of cytarabine plus 3 days of anthracycline drugs), but up to 40% of newly diagnosed AML patients do not achieve complete response (CR) during initial induction therapy, which is considered as refractory, or relapse within 6 months after achieving CR2.

MDS is a heterogeneous hematopoietic disease caused by abnormal pluripotent stem cells, and the condition is characterized by poor hematopoietic function, bone marrow failure, reduction in peripheral blood cells, and reduced survival rates. The incidence rate of MDS in China is approximately 5 cases per 100,000. Although hypomethylating agents can produce a high response rate in patients with MDS, many patients eventually develop drug resistance to hypomethylating agents. Patients who have developed the acquired drug resistance commonly face a very poor prognosis. In patients with high-risk MDS, treatment failure with hypomethylating agents is associated with an average survival of less than 6 months3. As a result, both refractory/progressed AML and MDS represent an urgent medical need for more effective therapies.

APG-115 is an orally administered, selective, small-molecule inhibitor of the MDM2-p53 protein-protein interaction (PPI). APG-115 has strong binding affinity to MDM2 and is designed to activate tumor suppression activity of p53 by blocking the MDM2-p53 PPI. APG-115 is the first MDM2-p53 inhibitor entering clinical development in China, with multiple ongoing clinical studies in solid tumors in China and the US. At present, APG-115 is being investigated in a range of hematologic malignancies globally.

"Currently, there remains to be significant unmet medical needs in the treatment of hematologic malignancies, including AML and MDS," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "We have also noticed that drug development targeting the MDM2-p53 pathway has received growing interest. As the first MDM2-p53 inhibitor entering clinical study in China, APG-115 has already demonstrated favorable safety profiles and preliminary efficacy in solid tumors. We will actively explore APG-115’s therapeutic potential in hematologic malignancies, to hopefully provide more options of AML and MDS treatment to patients in China and around the world."

References:

1.Chang R, Wu S, Chen W, et al. Analysis on epidemiological characteristics of leukemia in Gansu Province from 2003 to 2012 [Article in Chinese]. Modern Preventive Med. 2014;41(21):3841-04.

2.Thol F, Schlenk RF, Heuser M, Ganser A. 2015. How I treat refractory and early relapsed acute myeloid leukemia. Blood 126: 319-27

3.Prebet T, Gore SD, Esterni B, Gardin C, Itzykson R, et al. 2011. Outcome of high-risk myelodysplastic syndrome after Azacitidine treatment failure. J Clin Oncol 29: 3322-7

About APG-115

APG-115 is an orally administered, selective, small-molecule inhibitor of the MDM2-p53 PPI. APG-115 has strong binding affinity to MDM2 and is designed to activate p53 tumor suppression activity by blocking the MDM2-p53 PPI. Ascentage Pharma has previously commenced three clinical trials of APG-115 in the US, including a Phase I study as single agent, a Phase Ib/II study in combination with pembrolizumab for treatment of metastatic melanoma and other advanced solid tumors, and a Phase I/II study as a single agent or in combination with chemotherapy for treatment of salivary gland cancer. APG-115 is the first MDM2-p53 inhibitor to enter clinical studies in China. A Phase I study as a single agent, and a Phase Ib study as a single agent or in combination with chemotherapy for treatment of AML (acute myeloid leukemia) or MDS (myelodysplastic syndrome) are ongoing in China.

On July 22, 2020 Olema Oncology, a biopharmaceutical company developing innovative targeted therapies for women’s cancers, reported the closing of an oversubscribed $54 million Series B financing (Press release, Olema Pharmaceuticals, JUL 22, 2020, View Source [SID1234562240]). Proceeds will be used to advance OP-1250, the Company’s lead program in breast cancer, into Phase 1/2 clinical development and expand ongoing research and development activities.

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The financing was co-led by BVF Partners L.P., Logos Capital and Janus Henderson Investors, with participation from new investors Cormorant Asset Management, RA Capital Management, Wellington Management Company, Surveyor Capital (a Citadel company), Venrock Healthcare Capital Partners, and Foresite Capital. Graham Walmsley, M.D., Ph.D., Managing Partner at Logos Capital, has joined Olema’s Board of Directors, which also includes Frank McCormick, Ph.D., FRS, DSc (Hon), Professor, UCSF Helen Diller Family Comprehensive Cancer Center; Andy Rapapport, Partner Emeritus of August Capital; Gorjan Hrustanovic, Ph.D., Principal at BVF Partners, L.P.; and Cyrus Harmon, Ph.D., President and Chief Executive Officer of Olema Oncology.

"We are delighted to have the support of this premier syndicate of investors who share our commitment to developing targeted therapies designed to improve the lives of women living with breast cancer," said Dr. Harmon. "With our deep insight into the biology of breast cancer, including target engagement, receptor binding and intracellular signaling, we have carefully selected OP-1250 as our lead program and are advancing it into human studies. Our goal is to develop more effective medicines to treat estrogen receptor-positive breast cancer."

Olema expects to initiate a Phase 1/2 dose-escalation and expansion clinical trial of OP-1250 in the second half of 2020. The trial will evaluate OP-1250 as a single agent in women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) recurrent, locally advanced or metastatic breast cancer, followed by studies of OP-1250 in combination with other targeted breast cancer therapies.

"We are excited to continue financing the next stage of growth for Olema, and to help build a premier targeted oncology company focused on women’s cancers," said Dr. Hrustanovic. "We were attracted to Olema by its excellent science, robust preclinical data, experienced management team, and potential to make a significant impact on what remains a large unmet need among patients with breast and other hormone-positive cancers. We see a tremendous opportunity for OP-1250 to become a backbone of therapy for patients living with breast and other cancers."

On July 22, 2020 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, reported that it has commenced a registered underwritten public offering of its common shares (the "Offering") (Press release, Aurinia Pharmaceuticals, JUL 22, 2020, View Source [SID1234562239]).

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Jefferies and SVB Leerink are acting as joint book-running managers for the Offering.

The Company will grant the underwriters an option exercisable, in whole or in part, in the sole discretion of the underwriters, to purchase up to an additional 15% of common shares, for a period of up to 30 days. The Offering is subject to market conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.

The Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, research and development, as well as working capital and general corporate purposes.

The Offering is subject to customary closing conditions, including NASDAQ and TSX approvals. For the purposes of the TSX approval, the Company intends to rely on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as NASDAQ.

The Offering is being made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on June 19, 2020 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated June 17, 2020. The prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") will be filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement will be available upon request in the United States by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6218, or by email at [email protected]; and in Canada by contacting Jefferies Securities, Inc., attention: Steven Latimer, 161 Bay Street, Suite 2700 Toronto, Ontario M5J 2S1, by telephone at 416-572-2215.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.