On July 25, 2018 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the second quarter ending June 30, 2018 (Press release, Integra LifeSciences, JUL 25, 2018, View Source [SID1234527855]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Second Quarter 2018 Consolidated Results

Reported revenue was $366.2 million, an increase of 29.8% compared to the second quarter of 2017; the acquisition of Codman contributed $79.2 million of revenue to the second quarter, and organic revenues increased 3.4%. Relative to the foreign currency rates used in April 2018 guidance, the second quarter revenues would have been $368.4 million, if the foreign currency rates were stable throughout the quarter;

GAAP earnings per share was $0.14, flat compared to the second quarter of 2017;

Adjusted earnings per share was $0.60, reflecting an increase of 33.3% compared to the second quarter of 2017;

The company has successfully exited the first wave of Codman transition services agreements and assumed full operational control of all commercial services and functions covering approximately 60% of the revenue associated with the acquired business;

The company is raising the low end of its full-year 2018 total revenue and earnings per share guidance as follows:

Total revenue of $1.475 billion to $1.490 billion (previously $1.470 billion to $1.490 billion);

Guidance range reflects lower foreign currency benefit based on current rates (expected foreign currency benefit was reduced from $15 million to $8 million)

GAAP EPS of $0.71 to $0.77 (previously $0.69 to $0.77);

Adjusted EPS of $2.36 to $2.42 (previously $2.34 to $2.42); and

The company is reiterating full-year 2018 organic sales growth guidance of approximately 5%.

Total revenues for the second quarter of 2018 were $366.2 million, reflecting an increase of 29.8% over the second quarter of 2017. Sales in the Codman Specialty Surgical segment increased 49.8% compared to the second quarter of 2017, driven by the Codman acquisition and strong performance in the Dural Access and Repair and Advanced Energy businesses. Sales in the Orthopedics and Tissue Technologies segment increased 3.6%, reflecting broad-based strength in our regenerative technologies business, following the completion of the commercial expansion strategy.

Total organic revenues increased 3.4% over the second quarter of 2017, excluding acquisitions, divestitures and the effect of currency exchange rates.
"We look forward to an acceleration in organic growth in the second half of 2018, as we realize the benefits of a larger sales organization, improved sales productivity and an expanded product portfolio," said Peter Arduini, Integra’s president and chief executive officer. "The successful integration of Codman and the completion of the hiring associated with our OTT channel expansion strategy increase our confidence for the second half of the year."
The company reported GAAP net income of $11.4 million, or $0.14 per diluted share, for the second quarter of 2018, compared to GAAP net income of $10.8 million, or $0.14 per diluted share, in the second quarter of 2017. The slight increase in GAAP net income is a result of higher revenues and better operating expense leverage.
The adjusted measures discussed below are computed with the adjustments to GAAP reporting that are set forth in the attached reconciliation.

Adjusted EBITDA for the second quarter of 2018 was $85.9 million, or 23.5% of revenue, compared to $62.7 million, or 22.2% of revenue, in the second quarter of 2017. The margin improvement was largely based on better operating expense leverage, mostly from selling, general and administrative costs.
Adjusted net income for the second quarter of 2018 was $50.5 million, an increase of 42.7% from the prior year’s quarter. Adjusted earnings per share for the second quarter of 2018 was $0.60, an increase of 33.3% over the prior year’s quarter.
2018 Full-Year Outlook

The company is raising the low end of its full-year 2018 total revenue guidance by $5 million to a new range of $1.475 billion to $1.490 billion. The company is also raising the low end of its full-year 2018 GAAP earnings per share guidance range to $0.71 to $0.77, and adjusted earnings per share guidance range to $2.36 to $2.42, an increase of two cents.
The company expects full-year 2018 organic revenue growth to be approximately 5.0%, consistent with prior guidance.
"We were pleased with the strong operational performance from both segments in the second quarter, which enabled us to achieve 40% growth in adjusted net income and 130 basis points of adjusted EBITDA margin expansion, compared to the prior year’s quarter," said Glenn Coleman, Integra’s chief financial officer. "Given the strong momentum we expect in the second half of 2018, we are raising the low-end of our revenue and EPS guidance ranges."

In the future, the company may record, or expects to record, certain additional revenues, gains, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online
Integra has scheduled a conference call for 8:30 AM ET today, Wednesday, July 25, 2018, to discuss financial results for the second quarter and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the call.
Integra’s management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com.
Access to the live call is available by dialing (334) 323-0522 and using the passcode 7616000. The call can also be accessed via a webcast link provided on investor.integralife.com. A replay of the call will be available through July 30, 2018 by dialing (719) 457-0820 and using the passcode 7616000. The webcast will also be archived on the website.

On July 25, 2018 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq: EGRX) reported that the Company will release its 2018 second quarter financial results on Tuesday, August 7, 2018, before the market opens (Press release, Eagle Pharmaceuticals, JUL 25, 2018, View Source [SID1234527851]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will host a conference call to discuss the results as follows:

Date Tuesday, August 7, 2018
Time 8:30 a.m. EDT
Toll free (U.S.) 877-876-9177
International 785-424-1669
Webcast (live and replay)
www.eagleus.com, under the "Investor Relations" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-727-5306 (US) or 402-220-2670 (International) and entering conference call ID EGRXQ218. The webcast will be archived for 30 days at the aforementioned URL.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On July 24, 2018 A-Alpha Bio reported that it has been awarded a National Science Foundation Phase I Small Business Innovation Research (SBIR) grant for $225,000 to develop AlphaSeq: a cell-based platform that will accelerate cancer drug development by enabling high-throughput and quantitative characterization of protein-protein interactions (Press release, A-Alpha Bio, JUL 24, 2018, View Source [SID1234636894]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Proteins bind to one another, like Lego pieces, to form complex biological machines. In cancer cells, these machines are dysregulated, causing cell-survival and uncontrolled growth. Pharmaceutical companies are developing drugs that kill cancer cells by blocking key protein-protein interactions. However, blocking any of the millions of protein-protein interactions that occur in healthy cells could cause serious side-effects, making specificity a major concern.

"A-Alpha Bio’s AlphaSeq technology is a game-changer for preclinical drug screening," said Randolph Lopez, CTO and Co-founder of A-Alpha Bio. "It lets us measure the effect of a drug on thousands of protein-protein interactions simultaneously, instead of having to measure each one individually. Pharmaceutical companies will not have to limit their preclinical testing to a small number of likely off-target effects. With AlphaSeq, they can avoid costly and potentially life-threatening surprises during clinical trials by screening their drugs against whole protein networks"

Protein interactions are already widely recognized as being critically important for the development of many different types of drugs. AlphaSeq provides a unique advantage over existing approaches by combining high accuracy and throughput, which is enabled by advances in the fields of synthetic biology and DNA sequencing. This SBIR grant is aimed at expanding the capabilities of AlphaSeq for screening interactions with challenging proteins and insoluble small molecule drugs. Once completed, A-Alpha Bio will be eligible to apply for a Phase II grant (up to $750,000) for pilot testing and scale-up.

On July 24, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for CYAD-101, the first non-gene edited allogeneic clinical program (Press release, Celyad, JUL 24, 2018, View Source [SID1234532513]). The FDA has indicated that the Allo-SHRINK trial, evaluating the safety and clinical activity of CYAD-101 in patients with unresectable colorectal cancer in combination with standard chemotherapy, is allowed to proceed.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Christian Homsy, CEO of Celyad: "We are pleased to have achieved this important milestone. Celyad is the first company clinically evaluating a non-gene edited CAR-T candidate, which, we believe, offers significant advantages over gene edited approaches. Our non-gene edited program consists of a family of technologies aimed at reducing or eliminating T cell receptor (TCR) signaling without requiring genetic manipulation. CYAD-101 is part of a robust clinical development plan, establishing the foundations of next generation CAR-T products."

CYAD-101, Celyad’s first allogeneic CAR-T cell product, encodes both the company’s auto-logous CYAD-01 CAR-T and a novel peptide, TIM (TCR Inhibiting Molecule), an inhibitor of TCR signaling. TCR signaling is responsible for the Graft versus Host Disease (GvHD), and tampering or eliminating its signaling could therefore reduce or eliminate GvHD. In CYAD-101, the TIM peptide is encoded alongside the CAR construct allowing allogeneic T cell production through a single transduction step. CYAD-101 benefits from using a manufac-turing process that is highly similar to Celyad’s well established process for its clinical au-tologous CAR-T cell products.

While autologous CAR-T therapies now have well established efficacy in B cell malignancies, the approach can be more challenging for some patients, especially those where the quality of the apheresis is poor. Allogeneic CAR-T cell therapy may provide an alternative approach for this patient population, utilizing cells manufactured from a healthy donor which could allow greater reproducibility and reduced manufacturing costs.