Thermo Fisher Scientific Reports First Quarter 2019 Results

On April 24, 2019 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the first quarter ended March 30, 2019 (Press release, Thermo Fisher Scientific, APR 24, 2019, View Source [SID1234535358]).

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First Quarter 2019 Highlights

First quarter revenue increased to $6.12 billion.
First quarter GAAP diluted earnings per share (EPS) increased 41% to $2.02.
First quarter adjusted EPS increased 12% to $2.81.
Launched a range of new products, including two Thermo Scientific instruments for materials analysis – the Nicolet Summit FTIR spectrometer and the Helios 5 DualBeam scanning electron microscope – and in specialty diagnostics, received FDA clearance for a new ImmunoCAP test for peanut allergy.
Recently opened new Customer Solution Centers in Beijing and Delhi to help scientists in the food and beverage industry develop advanced analytical workflows that improve food quality and safety.
Announced $150 million expansion of our pharma services sites in Italy and North Carolina to increase capacity and capabilities of our global sterile manufacturing network and meet growing customer demand for biologics development and manufacturing services.
Announced agreement to acquire Brammer Bio, a leader in viral vector manufacturing, for $1.7 billion, significantly expanding our capabilities in the fast-growing gene and cell therapy market.
Repurchased $750 million of stock and increased our dividend by 12 percent.
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’re pleased to deliver another quarter of excellent growth on the top and bottom line," said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. "Our teams are strengthening our competitive position by successfully executing our growth strategy – a combination of launching great new products, leveraging our scale in high-growth and emerging markets, and enhancing our unique value proposition to be the strongest partner possible for our customers.

"I’m especially excited about our pending acquisition of Brammer Bio, which we announced in March. As a leader in viral vector manufacturing, Brammer Bio helps pharma and biotech customers deliver breakthrough gene and cell therapies to patients with rare diseases. We also continue to deploy capex to expand our pharma services capacity and capabilities in the U.S. and Europe to meet increasing customer demand and ultimately make a difference for countless patients and their families."

Casper added, "We’re off to a strong start, and we’re on track to deliver another outstanding year."

First Quarter 2019

Revenue for the quarter grew 5% to $6.12 billion in 2019, versus $5.85 billion in 2018. Organic revenue growth was 7%; acquisitions increased revenue by 1% and currency translation decreased revenue by 3%.

GAAP Earnings Results

GAAP diluted EPS in the first quarter of 2019 increased 41% to $2.02, versus $1.43 in the same quarter last year. GAAP operating income for the first quarter of 2019 grew to $0.92 billion, compared with $0.79 billion in the year-ago quarter. GAAP operating margin increased to 15.0%, compared with 13.4% in the first quarter of 2018.

Non-GAAP Earnings Results

Adjusted EPS in the first quarter of 2019 increased 12% to $2.81, versus $2.50 in the first quarter of 2018. Adjusted operating income for the first quarter of 2019 grew 7% compared with the year-ago quarter. Adjusted operating margin was 22.4%, compared with 22.0% in the first quarter of 2018.

2019 Guidance Update

Thermo Fisher is raising its 2019 revenue and earnings guidance to reflect strong operational performance and the acquisition of Brammer Bio, partially offset by a more adverse foreign exchange environment. The company is raising its revenue guidance to a new range of $25.17 to $25.47 billion versus its previous guidance of $24.88 to $25.28 billion. This would result in 3 to 5% revenue growth over 2018. The company is raising its adjusted EPS guidance to a new range of $12.08 to $12.22, versus its previous guidance of $12.00 to $12.20, for 9 to 10% growth year over year.

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 first quarter of 2019, Life Sciences Solutions Segment revenue grew 7% to $1.61 billion, compared with revenue of $1.50 billion in the first quarter of 2018. Segment adjusted operating margin increased to 34.9%, versus 34.5% in the 2018 quarter.

Analytical Instruments Segment

Analytical Instruments Segment revenue grew 5% to $1.32 billion in the first quarter of 2019, compared with revenue of $1.26 billion in the first quarter of 2018. Segment adjusted operating margin increased to 21.3%, versus 19.6% in the 2018 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue increased 1% to $0.96 billion in the first quarter of 2019, compared with revenue of $0.95 billion in the first quarter of 2018. Segment adjusted operating margin was 25.3%, versus 25.6% in the 2018 quarter.

Laboratory Products and Services Segment

In the first quarter of 2019, Laboratory Products and Services Segment revenue grew 4% to $2.51 billion, compared with revenue of $2.41 billion in the first quarter of 2018. Segment adjusted operating margin was 11.3%, versus 11.6% in the 2018 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, the impact of significant tax audits or events and the results of discontinued operations. 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, and also excludes operating cash flows from discontinued operations 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 first quarter of 2019, adjusted EPS 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, the early retirement of debt and discontinued operations.

We also report free cash flow, which is operating cash flow, excluding net capital expenditures, and also excludes operating cash flows from discontinued operations 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, April 24, 2019, 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, May 10, 2019.

Blue Earth Diagnostics Announces Presentations on Axumin® (Fluciclovine F 18), 18F-Fluciclovine and 18F-rhPSMA at Upcoming American Urological Association’s 2019 Annual Meeting

On April 24, 2019 Blue Earth Diagnostics, a molecular imaging diagnostics company, reported upcoming presentations at the American Urological Association’s 2019 Annual Meeting, AUA2019, being held May 3 – 6, 2019, in Chicago, Ill (Press release, Blue Earth Diagnostics, APR 24, 2019, View Source [SID1234535376]). Presentations on Axumin (fluciclovine F 18) Injection include additional analyses from the LOCATE clinical trial (NCT02680041), a prospective, U.S., multicenter, open-label study investigating the impact of 18F fluciclovine PET/CT imaging on patient management of biochemically recurrent prostate cancer after initial prostate cancer treatment and negative or equivocal findings on standard-of-care imaging.

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Additional presentations include an investigational use of 18F-fluciclovine and initial clinical experience by the Technical University of Munich with 18F-rhPSMA-7, a Prostate Specific Membrane Antigen-targeted radiohybrid PET imaging agent representative of the family of rhPSMA agents that the company licensed in 2018. Details of the presentations to be made by Blue Earth Diagnostics collaborators are listed below.

AXUMIN (FLUCICLOVINE F 18) PRESENTATIONS
Date: Friday, May 3, 2019
Presentation: PET/CT with 18F-fluciclovine to predict recurrence in post-treatment prostate cancer and its role in altering treatment plans
Abstract Number: MP13-01
Presenter: Julio Chong, MD, Icahn School of Medicine at Mt Sinai, New York, NY
Session Title & Times: Prostate Cancer: Detection and Screening I – 1:00 – 3:00 p.m. CT
Location: MCP: W180

Date: Saturday, May 4, 2019
Presentation: Localization of recurrence of prostate cancer with 18F-fluciclovine positron emission tomography in patients with and without prior prostatectomy: Results from LOCATE
Abstract Number: MP36-18
Presenter: Gerald Andriole, Jr., MD, Washington University, St. Louis, Mo. on behalf of the LOCATE study group
Session Title & Times: MP36: Prostate Cancer: Detection and Screening V – 1:00 – 3:00 p.m. CT
Location: MCP: W180

Date: Monday, May 6, 2019
Presentation: Sites of prostate cancer recurrence delineated with 18F-fluciclovine positron emission tomography in patients with negative or equivocal conventional imaging
Abstract Number: PD60-12
Presenter: Gerald Andriole, Jr., MD, Washington University, St. Louis, Mo. on behalf of the LOCATE study group
Session Title & Times: PD60: Prostate Cancer: Detection and Screening VII, 7:00 – 9:00 a.m. CT
Presentation Time: 8:50 – 9:00 a.m. CT
Location: MCP: W185d

INVESTIGATIONAL 18F-FLUCICLOVINE PRESENTATION
Date: Saturday, May 4, 2019
Presentation: Evaluation of fluciclovine (FACBC) PET scan for staging high-risk prostate cancer before primary treatment*
Abstract Number: PD23-08
Presenter: Mehrdad Alemozaffar, MD, Emory University, Atlanta, Ga.
Session Title & Times: PD23: Imaging/Radiology: Uroradiology I, 7:00 – 9:00 a.m. CT
Presentation Time: 8:10 – 8:20 a.m. CT
Location: MCP: W184d

PRESENTATIONS BY THE TECHNICAL UNIVERSITY OF MUNICH ON INITIAL CLINICAL EXPERIENCE WITH 18F-RHPSMA
Date: Friday, May 3, 2019
Presentation: 18F-rhPSMA-7 positron emission tomography for the detection of biochemical recurrence of prostate cancer following radical prostatectomy*
Abstract Number: MP09-16
Presenter: Tobias Maurer, MD, University of Hamburg-Eppendorf (previously Technical University of Munich), Germany
Session Title & Times: MP09: Prostate Cancer: Staging I – 9:30 – 11:30 a.m. CT
Location: MCP: 180

Date: Friday, May 3, 2019
Presentation: Diagnostic efficacy of 18F-rhPSMA-7 positron emission tomography for N-staging of patients with high risk primary prostate cancer*
Abstract Number: PD17-04
Presenter: Tobias Maurer, MD, University of Hamburg-Eppendorf (previously Technical University of Munich), Germany
Session Title & Times: PD17: Prostate Cancer: Staging II, 3:30 – 5:30 p.m. CT
Presentation Time: 4:00 – 4:10 p.m. CT
Location: MCP: 185d

Blue Earth Diagnostics invites participants at AUA2019 to attend the above presentations and to learn more about the company at Booth 3040.

NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Presentations noted by "*" discuss results of investigational studies or experiences with an investigational agent for which the safety and efficacy have not been established by the FDA.

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION ABOUT AXUMIN
INDICATION
Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at www.axumin.com.

ABOUT AXUMIN (FLUCICLOVINE F 18)
Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues, and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications, such as glioma.

Arrowhead Pharmaceuticals to Webcast Fiscal 2019 Second Quarter Results

On April 24, 2019 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it will host a webcast and conference call on May 8, 2019, at 4:30 p.m. EDT to discuss its financial results for the fiscal 2019 second quarter ended March 31, 2019 (Press release, Arrowhead Pharmaceuticals, APR 24, 2019, View Source [SID1234535393]).

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Conference Call and Webcast Details Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 5049067.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 5049067.

ABC2 Awards Grant to Develop Natural Disease History Benchmark for the Development of ONC201 in Midline Gliomas

On April 24, 2020 Oncoceutics reported that Accelerate Brain Cancer Cure (ABC2) has awarded a $116,523 grant to a research team at University of California, Los Angeles to perform a natural disease history study of adult midline gliomas, a certain type of aggressive brain tumors (Press release, Oncoceutics, APR 24, 2019, View Source [SID1234558358]). The study will follow patients from first diagnosis through a series of therapeutic interventions that for a subset of patients will include ONC201, an investigational agent in clinical trials for H3 K27M-mutant gliomas that has induced radiographic regressions in some patients.

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"Novel therapies are desperately needed for treatment of H3 K27M-mutant gliomas," said Max Wallace, Chief Executive Officer of ABC2. "A dedicated natural history study will open up the path to accelerated approval based on radiographic responses to new treatments such as ONC201 in this rare and immediately life-threatening disease."

ONC201 is the first antagonist of D2-like dopamine receptors DRD2/3 to be developed for clinical neuro-oncology. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ONC201 for the treatment of adult recurrent H3 K27M-mutant high-grade glioma. Diffuse midline gliomas harboring the histone H3 K27M mutation have a dismal prognosis with a median survival from diagnosis consistently reported to be between 8 and 11 months. The mutation was chosen by the World Health Organization (WHO) as a criterion for WHO grade IV designation, the most severe grade that is associated with a diffuse and aggressive growth pattern. No drug has been approved for H3 K27M-mutant glioma and no investigational therapy has shown clinically meaningful efficacy in this indication. Radiation is typically used in newly diagnosed patients and associated with some benefit before the tumor progresses, leading to the dismal survival rates.

Despite the increased awareness for the prognostic importance of the H3 K27M mutation, dedicated studies of midline gliomas are sparse, particularly in adults. Response criteria that are often applied, e.g. RANO criteria, were developed for supratentorial glioblastoma that have different radiographic features than midline gliomas, including H3 K27M-mutant gliomas. Consequently, the utility of these criteria for many midline glioma patients are confounded by a number of features often found in this disease: minimal or no contrast enhancement, diffuse growth, multifocal dissemination, and sub-centimeter lesions (not measurable as per some criteria). With the disease classifications that consider phenotypic as well as genotypic disease characteristics (e.g. WHO 2016) and patient registries that collect historical data the disease can be studied in more detail. However, many features of midline gliomas are still poorly understood, including tumor growth rates, dissemination patterns, response to therapies, and the relationship of clinical outcomes to these features.

"The goal of the study is to quantify the dynamics of how midline gliomas change over time on clinical imaging to better understand the natural progression of this disease and if treatments can alter those dynamics," said Timothy F. Cloughesy, MD, Clinical Professor and Director of the Neuro-Oncology Program at the University of California, Los Angeles. "The natural disease history could serve as a benchmark for new therapies such as ONC201 and other agents targeting glioma. We are very thankful to ABC2 for their support that will allow us to research this important and unaddressed topic."

BERGENBIO ASA: INVITATION TO FIRST QUARTER PRESENTATION AND WEBCAST

On April 24, 2019 BerGenBio ASA (OSE:BGBIO), reported that it will announce its results for the first quarter on Wednesday, 8 May 2019 (Press release, BerGenBio, APR 24, 2019, View Source [SID1234535359]). A presentation by BerGenBio’s senior management team will take place at 10:00 am CET at:

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Felix Konferansesenter,
Bryggetorget 3,
0125 Oslo.

The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in the section: Investors/Financial Reports from 7:00 am CET the same day.

-Ends-

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Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304

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+47 917 86 513

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