Exicure to Present at BIO CEO & Investor Conference, Immuno-Oncology 360° Summit and LEERINK Partners 7th Annual Global Healthcare Conference

On January 31, 2018 Exicure, Inc., the pioneer in gene regulatory and immunotherapeutic drugs utilizing three-dimensional, spherical nucleic acid (SNA) constructs, reported that Dr. David Giljohann, Chief Executive Officer of Exicure, will present a company update at the annual BIO CEO & Investor Conference on Tuesday, February 13, 2018 at 1:45 pm EST at the New York Marriott Marquis in New York City (Press release, Exicure, JAN 31, 2018, View Source;p=RssLanding&cat=news&id=2329459 [SID1234523655]). The company will also present at the Immuno-Oncology 360° Summit (IO360°) on Thursday, February 8, 2018 at 11:15 am EST. This meeting will take place at The Roosevelt Hotel in New York City.

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Additionally, the company plans to present a company overview at the LEERINK Partners 7th Annual Global Healthcare Conference on Wednesday, February 14, 2018 at 9:30 am EST at the Lotte New York Palace Hotel in New York City.

A live webcast of the BIO CEO & Investor Conference and the LEERINK Partners Global Healthcare Conference presentations will be available on the Events & Presentations section of Exicure’s website and will also be archived.

Protagonist Therapeutics to Participate in the Leerink Partners 7th Annual Global Healthcare Conference

On January 31, 2018 Protagonist Therapeutics, Inc. (NASDAQ: PTGX) reported that Dinesh V. Patel, Ph.D., the company’s President and Chief Executive Officer, will provide a corporate overview at the Leerink Partners 7th Annual Global Healthcare Conference taking place on February 14-15 at the Lotte New York Palace in New York, NY (Press release, Protagonist, JAN 31, 2018, View Source;p=RssLanding&cat=news&id=2329405 [SID1234523656]).

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The Protagonist Therapeutics presentation is scheduled for Wednesday, February 14 at 9:30 am Eastern Time.

A live audio webcast of the presentation may be accessed by visiting the Investors page of Protagonist Therapeutics corporate website at View Source A replay of the presentation will be available for 30 days following the presentation.

Thermo Fisher Scientific Reports Fourth Quarter and Full Year 2017 Results

On January 31, 2018 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the fourth quarter and full year ended December 31, 2017 (Press release, Thermo Fisher Scientific, JAN 31, 2018, View Source [SID1234523657]).

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Fourth Quarter and Full Year 2017 Highlights

Fourth quarter revenue grew 22% to $6.05 billion.

Full year revenue grew 14% to $20.92 billion.

Fourth quarter GAAP diluted earnings per share (EPS) decreased 18% to $1.30.
Full year GAAP diluted EPS increased 10% to $5.59. GAAP results include a one-time tax provision of $204 million associated with the recent enactment of tax reform legislation in the U.S.

Fourth quarter adjusted EPS increased 16% to $2.79.
Full year adjusted EPS increased 15% to $9.49.

Invested $0.9 billion in R&D during the year and launched high-impact products across all segments, highlighted by the Thermo Scientific Q-Exactive HF-X mass spectrometer, Thermo Scientific Krios G3i cryo transmission electron microscope, Applied Biosystems SeqStudio genetic analyzer and the Oncomine Dx Target Test.

Delivered strong year-over-year growth in Asia-Pacific and Emerging Markets, led by outstanding performance in China, and added new capabilities to support growth opportunities in China, South Korea and the Middle East.

Deployed $7.8 billion in 2017 on strategic acquisitions, adding leading biopharma contract development and manufacturing services through Patheon and expanding our offerings in bioproduction, cloud-based informatics, electron microscopy and transplant diagnostics.

Returned $1 billion of capital to shareholders in 2017 through stock buybacks and dividends.
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 an excellent 2017, with a very strong finish in the fourth quarter that capped off another outstanding year," said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. "Our performance demonstrates the continued success of our proven growth strategy and great execution by our teams.

"Among the highlights of 2017, we launched innovative new products in our key technology platforms, and enabled breakthroughs in proteomics, genetic analysis and structural biology. We continued to leverage our industry-leading scale to deliver strong performance in high-growth emerging markets, particularly China, India and South Korea. It was also a very active year for strategic M&A. We significantly enhanced our value proposition with the addition of Patheon’s leading services offering for pharma and biotech customers."

Casper concluded, "We’re in an excellent position as we begin 2018, and we’re energized about our prospects for the future."

Fourth Quarter 2017

Revenue for the quarter grew 22% to $6.05 billion in 2017, versus $4.95 billion in 2016. Organic revenue growth was 8%; acquisitions increased revenue by 11% and currency translation increased revenue by 3%.

GAAP Earnings Results

GAAP diluted EPS in the fourth quarter decreased to $1.30, versus $1.59 in the same quarter last year, due to the one-time tax provision previously noted. GAAP operating income for the fourth quarter of 2017 grew to $0.96 billion, compared with $0.75 billion in the fourth quarter of 2016. GAAP operating margin increased to 15.8%, compared with 15.2% in the fourth quarter of 2016.

Non-GAAP Earnings Results

Adjusted EPS in the fourth quarter of 2017 increased 16% to $2.79, versus $2.41 in the fourth quarter of 2016. Adjusted operating income for the fourth quarter of 2017 grew 18% compared with the year-ago quarter. Adjusted operating margin decreased 80 basis points to 24.0%, compared with 24.8% in the fourth quarter of 2016.

Full Year 2017

Revenue for the full year grew 14% to $20.92 billion in 2017, versus $18.27 billion in 2016. Organic revenue growth was 5%; acquisitions increased revenue by 9% and currency translation increased revenue slightly.

GAAP Earnings Results

GAAP diluted EPS for the full year increased to $5.59, versus $5.09 in 2016. GAAP diluted EPS in 2017 reflects the one-time tax provision. GAAP operating income for 2017 grew to $2.97 billion, compared with $2.45 billion a year ago. GAAP operating margin was 14.2% in 2017, compared with 13.4% in 2016.

Non-GAAP Earnings Results

Adjusted EPS for the full year rose 15% to $9.49, versus $8.27 in 2016. Adjusted operating income for 2017 grew 15% compared with 2016, and adjusted operating margin expanded 10 basis points to 23.2%, compared with 23.1% a year ago.

Annual Guidance for 2018

The company will provide 2018 financial guidance on its earnings conference call this morning at 8:30 a.m. Eastern time.

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 fourth quarter of 2017, Life Sciences Solutions Segment revenue grew 11% to $1.58 billion, compared with revenue of $1.42 billion in the fourth quarter of 2016. Segment adjusted operating margin increased to 35.6%, versus 32.9% in the 2016 quarter.

For the full year 2017, Life Sciences Solutions Segment revenue rose 8% to $5.73 billion, compared with revenue of $5.32 billion in 2016. Segment adjusted operating margin increased to 33.1% in 2017, compared with 30.0% a year ago.

Analytical Instruments Segment

Results for the Analytical Instruments Segment reflect the acquisition of FEI Company in September 2016. Segment revenue grew 16% to $1.41 billion in the fourth quarter of 2017, compared with revenue of $1.22 billion in the fourth quarter of 2016. Segment adjusted operating margin was flat at 24.5%.

For the full year 2017, Analytical Instruments Segment revenue rose 31% to $4.82 billion, compared with revenue of $3.67 billion in 2016. Segment adjusted operating margin grew to 21.3%, versus 20.3% in 2016.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue grew 10% to $0.91 billion in the fourth quarter of 2017, compared with revenue of $0.83 billion in the fourth quarter of 2016. Segment adjusted operating margin was 26.5%, versus 27.2% in the 2016 quarter.

For the full year 2017, Specialty Diagnostics Segment revenue grew 4% to $3.49 billion, compared with revenue of $3.34 billion in 2016. Segment adjusted operating margin was 26.7%, versus 2016 results of 27.2%.

Laboratory Products and Services Segment

Laboratory Products and Services Segment results reflect the acquisition of Patheon in late August 2017. In the fourth quarter of 2017, segment revenue grew 43% to $2.40 billion, compared with revenue of $1.68 billion in the fourth quarter of 2016. Segment adjusted operating margin was 12.5%, versus 14.0% in the 2016 quarter.

For the full year 2017, Laboratory Products and Services Segment revenue grew 16% to $7.83 billion, compared with revenue of $6.72 billion in 2016. Segment adjusted operating margin was 12.9%, versus 14.4% in 2016.

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, benefits from tax credit carryforwards, 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 5 to 20 years. In 2018, based on acquisitions closed through the end of 2017, our adjusted EPS 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, benefits from tax credit carryforwards and the impact of significant tax audits or events (such as the effect on deferred tax balances of enacted changes in tax rates or, in 2017, the incremental impact of tax reform legislation in the U.S.), 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, January 31, 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, February 16, 2018.

Atossa Genetics to Host Conference Call to Present Additional Findings from its Phase 1 Study of Oral Endoxifen Thursday February 1, 2018 at 4:30 pm EST

On January 31, 2018 Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, reported that it will host a conference call on February 1, 2018 at 4:30 pm EST to discuss additional findings from its Phase 1 study of Atossa’s proprietary oral Endoxifen (Press release, Atossa Genetics, JAN 31, 2018, http://ir.atossagenetics.com/news/detail/836/atossa-genetics-to-host-conference-call-to-presentadditional-findings-from-itsphase-1-study-of-oral-endoxifenthursday-february-1-2018-at-4-30-pm-est [SID1234523648]). Endoxifen is an active metabolite of the FDA-approved drug tamoxifen, which is currently used to treat breast cancer and for breast cancer prevention in high-risk patients.

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The objectives of this double-blinded, placebo-controlled, Phase 1 study of 48 healthy female subjects were to assess the pharmacokinetics of proprietary formulations of both oral and topical Endoxifen dosage forms as single (oral) and repeat (oral and topical) doses, as well as to assess safety and tolerability. Preliminary results from the study, which were announced on September 14, 2017 and October 25, 2017, showed that all objectives of the study were successfully met: there were no clinically significant safety signals and no clinically significant adverse events and both the oral and topical Endoxifen were well tolerated. In the topical arm of the study, low but measurable Endoxifen levels were detected in the blood in a dose-dependent fashion. In the oral arm of the study, participants exhibited dose-dependent Endoxifen levels that met or exceeded the published therapeutic level.

Additional findings from the oral arm of the Phase 1 study will be announced during the conference call on February 1, 2018. Due to expected high call attendance, participants are asked to preregister for the call through the following link: View Source Please note that registered participants will receive their dial in number upon registration and will dial directly into the call without delay. Those without internet access or who are unable to pre-register may dial in by calling: 1-844-824-3830 (domestic), 1-412-317-5140 (international) and Canada Toll Free: 1-855-669-9657. Callers should ask to be joined into the Atossa Genetics call.

The conference call will also be available through a live webcast at www.atossagenetics.com. Details for the webcast may be found on the Company’s IR events page at View Source

Management will answer pre-submitted questions gathered prior to the conference call in the Question and Answer period of the call. Interested parties may submit questions for management’s consideration prior to the call by submitting them in writing to Atossa Genetics’ Investor Relations at [email protected].

A replay of the call will be available approximately one hour after the end of the call through March 1, 2018. The replay can be accessed via Atossa’s website or by dialing 877-344-7529 (domestic) or 412-317-0088 (international) or Canada Toll Free at 855-669-9658. The replay access code is 10116753.

Atossa is developing proprietary Endoxifen with two routes of delivery to potentially address two distinct patient populations: oral Endoxifen for breast cancer survivors and topical Endoxifen for women with a condition called mammographic breast density (or, MBD). When a patient is treated for breast cancer, doctors typically prescribe oral tamoxifen for 5-10 years to reduce the risk of recurrent and new tumors. Tamoxifen can have uncomfortable as well as serious side effects. Perhaps more importantly, not all patients benefit from tamoxifen therapy due to their inability to effectively metabolize tamoxifen into Endoxifen. Recent research continues to confirm the key role Endoxifen plays in reducing the risk of recurrent and new breast cancer in these patients. It is estimated that more than one million breast cancer survivors in the U.S. are recommended to take tamoxifen. Atossa is developing oral Endoxifen for these patients who are "refractory" to tamoxifen meaning that they are not benefiting from tamoxifen.

There is no FDA-approved treatment for MBD, which affects more than ten million women in the U.S. It is well accepted that MBD increases the risk of breast cancer, which is why approximately 30 states now require that a finding of MBD be reported to the patient, physician or both. It is believed that not only does MBD make mammography less effective because MBD can hide cancerous tumors, but also the tissue itself may be more prone to develop cancer. For these reasons, Atossa is developing topical Endoxifen as a potential treatment for MBD.

Results from Atossa’s Phase 1 study have paved the way for upcoming Phase 2 studies: a study using Atossa’s proprietary topical Endoxifen to treat MBD which will be performed at South General Hospital in Stockholm and a study using Atossa’s proprietary oral Endoxifen to treat women who are refractory to tamoxifen. We plan to open both of these studies in the first quarter of 2018.

Atossa has also started a program to deliver Chimeric Antigen Receptor Therapy, or CAR-T, cells into the ducts of the breast for the potential targeted treatment of breast cancer. This is a novel approach using Atossa’s proprietary intraductal microcatheter technology for the potential transpapillary, or "TRAP," delivery of T-cells that have been genetically modified to attack breast cancer cells. We believe this method has several potential advantages including the reduction of toxicity by limiting systemic exposure of the T-cells; improved efficacy by placing the T-cells in direct contact with the target ductal epithelial cells that are undergoing malignant transformation; and, lymphatic migration of the CAR-T cells potentially extending their cytotoxic actions into the regional lymph system, which could limit tumor cell dissemination. We are also using our intraductal microcatheters in a Phase 2 study at Montefiore Medical Center in New York where we are targeting the delivery of Fulvestrant to the site of early stage breast cancer and ductal carcinoma in situ.

Atossa is developing its products to reduce the risk of developing breast cancer and to provide new approaches to effectively treat breast cancer patients in a cost-effective and safer manner. A study conducted by Defined Health, a leading market research firm, estimates that the potential market for Endoxifen exceeds $1 billion in annual sales and the potential market for Atossa’s intraductal microcatheters to delivery therapeutics exceeds $800 million as a treatment and replacement for surgery.

CAR-T has been the subject of much attention recently. In October 2017, pioneer CAR-T company Kite Pharma was acquired for $11.9 billion by Gilead; in August 2017 Novartis received the first FDA approval in the CAR-T field for Kymriah for the treatment of B-cell Acute Lymphoblastic Leukemia; and in January 2018 Celgene Corporation announced the acquisition of Juno Therapeutics for $9 billion.

Atossa’s 2018 potential milestones include:

First quarter of 2018 – opening the Phase 2 Study of topical Endoxifen to treat MBD at Stockholm South General Hospital in Sweden (which we plan to complete in 2018).
First quarter of 2018 – opening the Phase 2 Study of oral Endoxifen to treat patients who are not responding to Tamoxifen (which we plan to complete in 2018).
Second half of 2018 – commencing one or more studies administering TRAP CAR-T with our microcatheters.
Throughout 2018 – continuing our Phase 2 study administering Fulvestrant with our microcatheters.
The American Cancer Society (ACS) estimates that approximately 250,000 women will be diagnosed with breast cancer in the United States this year and that approximately 40,000 will die from the disease. It is the second leading cause of cancer death in American women. Although about 100 times less common than women, breast cancer also affects men. The ACS estimates that the lifetime risk of men getting breast cancer is about 1 in 1,000; 2,470 new cases of invasive breast cancer will be diagnosed; and 460 men will die from breast cancer in 2017.

Alexion to Present at the Leerink Partners 7th Annual Global Healthcare Conference

On January 31, 2018 Alexion Pharmaceuticals (Nasdaq: ALXN) reported that management will present at the Leerink Partners 7th Annual Global Healthcare Conference in New York City on Wednesday, February 14, 2018 at 11:00 a.m., ET (Press release, Alexion, JAN 31, 2018, View Source [SID1234523659]).

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An audio webcast of the presentation will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.