Pacira to Report Second Quarter 2018 Financial Results on Thursday August 2, 2018

On July 25, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported that it will report its second quarter financial results before the open of the U.S. markets on Thursday, August 2, 2018 (Press release, Pacira Pharmaceuticals, JUL 25, 2018, View Source;p=RssLanding&cat=news&id=2359881 [SID1234527867]). Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

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To participate in the conference call, dial 1-877-845-0779 and provide the passcode 5387259. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 5387259. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

Varian Reports Results for Third Quarter of Fiscal Year 2018

On July 25, 2018 Varian (NYSE: VAR) reported its third quarter fiscal year 2018 results (Press release, Varian Medical Systems, JUL 25, 2018, View Source [SID1234527868]). All comparisons in this announcement are year-over-year unless noted otherwise.

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GAAP Net Earnings, GAAP Net Earnings per Diluted Share, Non-GAAP Net Earnings and Non-GAAP Net Earnings per Diluted Share refer only to continuing operations.

Non-GAAP Net Earnings and Non-GAAP Net Earnings per Diluted Share are defined as GAAP Net Earnings and GAAP Net Earnings per Diluted Share adjusted to exclude the amortization of intangible assets, acquisition-related expenses and benefits, restructuring and impairment charges, significant litigation charges or benefits, legal costs and significant effects of tax legislation.

"In the third quarter, the team continued to deliver robust results, and we strengthened our leadership in radiation therapy with strong orders and revenue performance," said Dow Wilson, Chief Executive Officer of Varian. "Investment will continue to be a key driver of our long-term growth and value creation, and we made strategic investments in the quarter in R&D, Sales, and Marketing to support the company’s future innovation and growth strategies."

The company ended the quarter with $536 million in cash and cash equivalents and $18 million of debt. Net cash provided by operating activities was $102 million. During the quarter, the company invested $39 million to repurchase 325,000 shares of common stock.

Oncology Systems Segment
In the fiscal third quarter, Oncology revenues totaled $667 million, up 18 percent in dollars and 16 percent in constant currency. Gross orders were $763 million, up 11 percent in dollars and 9 percent in constant currency. Gross orders in the Americas increased 9 percent in dollars and in constant currency, driven by North America at 9 percent. In EMEA, gross orders rose 27 percent in dollars and 21 percent in constant currency; in APAC, gross orders decreased 7 percent in dollars and 9 percent in constant currency. Operating earnings for the segment increased 20 percent.

Particle Therapy Segment
In the fiscal third quarter, Particle Therapy revenues totaled $42 million, down 39 percent. The company did not book any new ProBeam orders in the quarter.

Acquisition-Related Expenses and Impairment Charges in Q3
Varian’s GAAP net earnings include acquisition-related expenses totaling $13 million for the quarter, primarily driven by acquisition costs and the loss related to hedging the Australian dollar purchase price of Sirtex, partially offset by the breakup fee received from Sirtex in connection with the termination of the acquisition. Additionally, GAAP net earnings include an impairment charge of $11 million related to the expected refinancing of the Maryland Proton Treatment Center in Baltimore. Together, these costs, and their associated tax effects, reduced Varian’s net earnings in the third quarter of fiscal 2018 by $0.20 per diluted share on a GAAP basis, and were excluded from non-GAAP results.

FY18 Annual Guidance Updated
Considering the financial and operational performance year-to-date and the impact of currency and tariffs, fiscal year 2018 guidance is updated to the following:

Revenue growth range of 9 percent to 11 percent
Non-GAAP Operating earnings as a percentage of revenues range of 17.5 percent to 18.0 percent
Non-GAAP effective tax rate of 20 percent
Weighted average diluted shares of 93 million
Non-GAAP Net Earnings per diluted share range of $4.43 to $4.48
Cash flows from operations range of $475 million to $550 million
Please refer to "Discussion of Non-GAAP Financial Measures" below for a description of items excluded from expected non-GAAP earnings.

Investor Conference Call
Varian Medical Systems is scheduled to conduct its third quarter fiscal year 2018 conference call at 2:00 p.m. Pacific Time today. To access the live webcast or replay of the call, visit the Investor Relations page on our website at www.varian.com/investors. To access the call via telephone, dial 1-877-869-3847 from inside the U.S. or 1-201-689-8261 from outside the U.S. The replay can be accessed by dialing 1-877-660-6853 from inside the U.S. or 1-201-612-7415 from outside the U.S. and entering conference ID 13680748. The teleconference replay will be available through 5:00 p.m. Pacific Time, Friday, July 27, 2018.

Innovent Receives IND Approval to Initiate Clinical Trials in China with its anti-OX40 Agonistic Antibody IBI101 and its anti-RANKL Antibody IBI307

On July 25, 2018 Innovent Biologics, a world-class China-based biopharmaceutical company that develops and intends to commercialize high quality innovative antibody-based therapeutics, reported that it has received Investigational New Drug (IND) approval from the China Food and Drug Administration (CFDA) to initiate clinical trials in China with IBI101, an anti-OX40 agonistic antibody, and with IBI307, an anti-RANKL antibody (Press release, Innovent Biologics, JUL 25, 2018, View Source [SID1234527869]).

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Innovent’s IBI101, is the first OX40-targeted molecule to receive IND approval in China. OX40 is one of the most important targets in the field of immune-oncology. Innovent will be among one of a few companies pursuing the development of OX40 agonists in early stage clinical trials globally. IBI307 is an anti-RANKL antibody under development for the treatment of osteoporosis and lytic bone lesions associated with cancer metastasis. Currently there is no anti-RANKL inhibitors approved for marketing in China.

"The IND approvals for IBI101 and IBI307 by CFDA once again demonstrate Innovent’s capability and commitment to lead the rapid development of China’s biopharmaceutical market. As part of our 17 drug candidates under development, we will prepare to bring these two targeted therapeutic agents into clinical trials quickly," said Michael Yu, Founder, Chief Executive Officer and Chairman. "Innovent will continue to discover and develop new biopharmaceutical drugs to expand our portfolio of products to treat patients. With today’s rapid improvements in cancer treatment modalities, we will utilize our well-established platform to discover, develop, manufacture and commercialize innovative high-quality biopharmaceutical drugs."

About IBI101

IBI-101 is a fully human monoclonal antibody drug candidate that was developed to treat cancers and hepatitis B. IBI101 binds to and stimulates OX40, which should increase the survival and activation of tumor specific T cells. OX40 agonists can be combined with a variety of therapeutic products, such as our PD-1 mAb, sintilimab, and other products in our pipeline, resulting in improved outcomes for patients. Innovent intends to pursue simultaneous development of this asset in China as well as outside of China. There are currently no OX40 agonists approved globally.

About IBI307

IBI307 is a fully human monoclonal antibody drug candidate that we are developing for the treatment of osteoporosis and lytic bone lesions associated with cancer metastasis. It binds to RANKL (RANK ligand), a molecule that controls the activation and survival of osteoclasts, the cells that remodel bone. By blocking the activity of RANKL, bone resorption is inhibited resulting in stronger and denser bones. There are currently no RANKL inhibitors approved for marketing in China.

Thermo Fisher Scientific Reports Second Quarter 2018 Results

On July 25, 2018 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the second quarter ended June 30, 2018 (Press release, Thermo Fisher Scientific, JUL 25, 2018, View Source [SID1234527850]).

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Second Quarter 2018 Highlights

Grew revenue 22% to $6.08 billion.
Increased GAAP diluted earnings per share (EPS) 19% to $1.85.
Increased adjusted EPS 20% to $2.75.
Launched suite of new mass spectrometry systems for life sciences and applied markets – highlighted by the Thermo Scientific Q Exactive UHMR for protein research – as well as new products for clinical research and diagnostics, including the Ion Torrent Oncomine Childhood Cancer Research Assay and the Thermo Scientific B.R.A.H.M.S. Kryptor Gold immunoassay analyzer in Europe.
Opened new Precision Medicine Science Center in the U.S., giving customers greater access to the range of technologies and expertise we offer to help them accelerate development of individualized patient treatments.
Announced agreement to acquire Gatan Inc., a leading provider of instrumentation and software to enhance the performance of electron microscopy systems.
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 excellent quarter, which reflects the strength of our global competitive position," said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. "Conditions across our end markets globally were strong and our team executed well to capture the opportunities for growth.

"Among the highlights during the quarter, we launched a comprehensive line-up of new products to help our customers meet their goals in life science research, applied markets and clinical settings. We continued to effectively leverage our scale to deliver strong growth in Asia-Pacific and emerging markets, including China. We also announced our agreement to acquire Gatan, which is a great fit with our electron microscopy business and will strengthen our customer offering."

Casper added, "Our excellent first half of the year positions us to achieve a very successful 2018."

Second Quarter 2018

Revenue for the quarter grew 22% to $6.08 billion in 2018, versus $4.99 billion in 2017. Organic revenue growth was 8%; acquisitions increased revenue by 12% and currency translation increased revenue by 2%.

GAAP Earnings Results

GAAP diluted EPS in the second quarter increased 19% to $1.85, versus $1.56 in the same quarter last year. GAAP operating income for the second quarter of 2018 grew to $0.94 billion, compared with $0.75 billion in the second quarter of 2017. GAAP operating margin increased to 15.4%, compared with 15.0% in the second quarter of 2017.

Non-GAAP Earnings Results

Adjusted EPS in the second quarter of 2018 increased 20% to $2.75, versus $2.30 in the second quarter of 2017. Adjusted operating income for the second quarter of 2018 grew 21% compared with the year-ago quarter. Adjusted operating margin was 23.1%, compared with 23.2% in the second quarter of 2017.

2018 Guidance Update

Thermo Fisher is raising its 2018 revenue and earnings guidance to reflect strong operational performance, partially offset by less favorable foreign exchange. The company is raising its revenue guidance to a new range of $23.68 to $23.86 billion versus its previous guidance of $23.62 to $23.86 billion. This would result in 13 to 14% revenue growth over 2017. The company is raising its adjusted EPS guidance to a new range of $10.89 to $11.01, versus its previous guidance of $10.80 to $10.96, for 15 to 16% 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 second quarter of 2018, Life Sciences Solutions Segment revenue grew 12% to $1.57 billion, compared with revenue of $1.40 billion in the second quarter of 2017. Segment adjusted operating margin increased to 33.3%, versus 31.9% in the 2017 quarter.

Analytical Instruments Segment

Analytical Instruments Segment revenue grew 13% to $1.31 billion in the second quarter of 2018, compared with revenue of $1.17 billion in the second quarter of 2017. Segment adjusted operating margin increased to 22.2%, versus 19.9% in the 2017 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue grew 8% to $0.93 billion in the second quarter of 2018, compared with revenue of $0.86 billion in the second quarter of 2017. Segment adjusted operating margin was 27.2% in both periods.

Laboratory Products and Services Segment

Laboratory Products and Services Segment results reflect the acquisition of Patheon in late August 2017. In the second quarter of 2018, segment revenue grew 42% to $2.55 billion, compared with revenue of $1.79 billion in the second quarter of 2017. Segment adjusted operating margin was 13.2%, versus 13.7% in the 2017 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 from continuing operations, less 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. In 2018, based on acquisitions closed through the end of the second quarter of 2018, our adjusted EPS will exclude approximately $3.35 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 from continuing operations, less 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 25, 2018, at 8:30 a.m. Eastern time. To listen, dial (844) 579-6824 within the U.S. or (763) 488-9145 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 10, 2018.

Tolero Pharmaceuticals Announces First Patient Dosed with Investigational Agent TP-0184, an Activin A Receptor Type 1 (ACVR1) Inhibitor, in Phase 1 Study of Patients with Advanced Solid Tumors

On July 25, 2018 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported that the first patient has been dosed in a Phase 1 study evaluating investigational agent TP-0184, an activin A receptor type 1 (ACVR1) inhibitor, in patients with advanced solid tumors (Press release, Tolero Pharmaceuticals, JUL 25, 2018, View Source [SID1234527870]). The Phase 1, open-label, dose-escalation study will evaluate the safety, pharmacokinetics, and pharmacodynamics of TP-0184 administered orally daily for the first 21 days of a 28-day cycle across a range of doses.

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"The initiation of this study of TP-0184 represents an important milestone for Tolero Pharmaceuticals, as it marks the second investigational agent from our development program to enter the clinical research stage this year,"said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals, Inc. "We look forward to understanding more about the profile of TP-0184 and its role in inhibiting ACVR1, which is mutated in approximately 1-4 percent of solid tumors and 32 percent of diffuse intrinsic pontine gliomas (DIPGs), an aggressive form of pediatric brain cancer."

The primary objective of the Phase 1 study is to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of TP-0184 orally administered daily for 21 days, over a range of doses in patients with advanced solid tumors. Secondary objectives in the study are to evaluate the pharmacokinetics and pharmacodynamics of TP-0184, observe patients for any evidence of antitumor activity of TP-0184 by objective radiographic assessment, and establish the recommended Phase 2 dose for future studies with TP-0184. The trial is being conducted at sites in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT03429218).

About TP-0184
TP-0184 is small molecule inhibitor of ACVR1, an activin A receptor type 1 (ACVR1) inhibitor, which is involved in the transforming growth factor beta (TGFβ) signaling pathway. ACVR1, also known as activin receptor-like kinase 2 (ALK2), is mutated in multiple types of cancers, including diffuse intrinsic pontine glioma (DIPG), a malignancy with high morbidity and mortality affecting the pediatric population.1,2,3 ACVR1 mutations are present in approximately 1-4 percent of solid tumors and, more commonly, in 32 percent of diffuse intrinsic pontine gliomas (DIPGs), a brain cancer with high morbidity and mortality afflicting the pediatric population.4,5 There is currently no approved therapy for the treatment of DIPG. ACVR1 is also involved in regulation of iron hemostasis, through stabilization of hepcidin and reduction of bioavailable iron, which is associated with anemia of chronic inflammation.4 TP-0184 is currently being evaluated in a Phase 1 clinical trial in advanced solid tumors (NCT03429218).