The Medicines Company Reports First-Quarter 2018 Results

On April 25, 2018 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the first quarter ended March 31, 2018 (Press release, Medicines Company, APR 25, 2018, View Source;p=RssLanding&cat=news&id=2344446 [SID1234525674]).

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Thermo Fisher Scientific (PRNewsfoto/Thermo Fisher Scientific)

First Quarter 2018 Highlights

First quarter revenue grew 23% to $5.85 billion.
First quarter GAAP diluted earnings per share (EPS) increased 2% to $1.43.
First quarter adjusted EPS increased 20% to $2.50.
Launched new products across our portfolio, including Thermo Scientific Vanquish Duo UHPLC systems for pharma QA/QC, the Thermo Scientific Chromeleon XTR Laboratory Management System and the Ion GeneStudio S5 Series of next-generation sequencing instruments.
Held first China-U.S. Precision Medicine Summit in Beijing, convening more than 400 thought leaders across government, academia and industry to promote global collaboration in the prevention, diagnosis and treatment of disease.
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 start the year on a very strong note, with excellent revenue and earnings growth," said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. "Our team did a great job meeting customer needs across our end markets and successfully executed our growth strategy to deliver outstanding results.

"On the innovation front, we kicked off 2018 by strengthening our leading technology platforms, including new instruments and software that help our customers to simplify workflows and better manage information in their labs. Geographically, we continued to leverage our industry-leading scale to deliver another great quarter in emerging and high-growth regions, with double-digit growth in China, India and South Korea. We also continued to demonstrate the power of our customer value proposition, especially in pharma and biotech, where we’re making great progress in integrating the capabilities we gained from the Patheon acquisition to make our offering for these customers even stronger."

Casper concluded, "We’re off to a great start in 2018, which positions us to deliver another excellent year."

First Quarter 2018

Revenue for the quarter grew 23% to $5.85 billion in 2018, versus $4.77 billion in 2017. Organic revenue growth was 7%; acquisitions increased revenue by 12% and currency translation increased revenue by 4%.

GAAP Earnings Results

GAAP diluted EPS in the first quarter increased 2% to $1.43, versus $1.40 in the same quarter last year. GAAP operating income for the first quarter of 2018 grew to $0.79 billion, compared with $0.62 billion in the first quarter of 2017. GAAP operating margin increased to 13.4%, compared with 13.0% in the first quarter of 2017.

Non-GAAP Earnings Results

Adjusted EPS in the first quarter of 2018 increased 20% to $2.50, versus $2.08 in the first quarter of 2017. Adjusted operating income for the first quarter of 2018 grew 20% compared with the year-ago quarter. Adjusted operating margin was 22.0%, compared with 22.5% in the first quarter of 2017.

2018 Guidance Update

Thermo Fisher is raising its 2018 revenue and earnings guidance to reflect strong operational performance, a more significant impact from acquisitions and a more favorable foreign exchange environment. The company is raising its revenue guidance to a new range of $23.62 to $23.86 billion versus its previous guidance of $23.42 to $23.72 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 $10.80 to $10.96, versus its previous guidance of $10.68 to $10.88, for 14 to 15% 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 2018, Life Sciences Solutions Segment revenue grew 10% to $1.50 billion, compared with revenue of $1.36 billion in the first quarter of 2017. Segment adjusted operating margin increased to 34.5%, versus 31.8% in the 2017 quarter.

Analytical Instruments Segment

Analytical Instruments Segment revenue grew 19% to $1.26 billion in the first quarter of 2018, compared with revenue of $1.05 billion in the first quarter of 2017. Segment adjusted operating margin increased to 19.6%, versus 18.2% in the 2017 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue grew 9% to $0.95 billion in the first quarter of 2018, compared with revenue of $0.87 billion in the first quarter of 2017. Segment adjusted operating margin was 25.6%, versus 26.9% in the 2017 quarter.

Laboratory Products and Services Segment

Laboratory Products and Services Segment results reflect the acquisition of Patheon in late August 2017. In the first quarter of 2018, segment revenue grew 42% to $2.41 billion, compared with revenue of $1.70 billion in the first quarter of 2017. Segment adjusted operating margin was 11.6%, versus 12.7% 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, 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. In 2018, based on acquisitions closed through the end of the first quarter of 2018, our adjusted EPS will exclude approximately $3.42 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 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, May 11, 2018.

NanOlogy to Present Abstract on Preclinical Study of Nebulized NanoPac for Lung Cancer at 2018 ASCO Annual Meeting

On April 25, 2018 NanOlogy LLC, a clinical-stage pharmaceutical development company, reported that it will present an abstract detailing results of a preclinical trial of a nebulized form of NanoPac (submicron particle paclitaxel) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting in Chicago, June 1 – 5 (Press release, NanOlogy, APR 25, 2018, View Source [SID1234525695]).

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The abstract, "NanoPac Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model," will be presented Sunday, June 3, 8 am to 11:30 am, in Hall A of the McCormick Place.

NanOlogy is currently conducting Phase 2 clinical trials of NanoPac sterile suspension for ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer and pancreatic mucinous cysts.

In addition, NanOlogy and affiliate, DFB Soria, are progressing clinical trials of Soria-developed SOR007, a topical ointment form of NanoPac for cutaneous metastases and actinic keratosis. Clinical trials for NanoDoce, (submicron particle docetaxel) are planned in 2018 pending IND approval.

The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into patent-pending, stable, naked submicron particles with exponentially increased surface area and unique geometry. The technology enables delivery of concentrated doses of paclitaxel and docetaxel directly into the disease site without the serious adverse side effects associated with systemic infusions of the chemotherapy.

Adaptimmune to Report First Quarter 2018 Financial Results and Business Update on Wednesday May 9, 2018

On April 25, 2018 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it will announce financial results for the First Quarter 2018 and provide a general business update before the open of the U.S. markets on Wednesday May 9, 2018 (Press release, Adaptimmune, APR 25, 2018, View Source;p=RssLanding&cat=news&id=2344498 [SID1234525678]). Following the announcement, the company will host a live teleconference and webcast at 8:00 a.m. EDT (1:00 p.m. BST) on the same day.

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The press release and the live webcast of the conference call will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address.

To participate in the live conference call, if preferred, please dial (833) 652-5917 (U.S.) or (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (2967789).

NewLink Genetics Announces Presentation of Abstracts at ASCO 2018 Annual Meeting

On April 25, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) today reported that two abstracts pertaining to the company’s indoximod program will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting in Chicago (Press release, NewLink Genetics, APR 25, 2018, View Source [SID1234525696]).

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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

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Poster Discussion Session: Poster Board #204 – Abstract 4015 – Phase 2 trial of the IDO pathway inhibitor indoximod plus gemcitabine / nab-paclitaxel for the treatment of patients with metastatic pancreas cancer – to be presented during the discussion session, "Gastrointestinal (Noncolorectal) Cancer," Sunday, June 3, 2018, 4:45 PM – 6:00 PM CT

Poster Discussion Session: Poster Board #339 – Abstract 9512 – Phase 2 trial of the IDO pathway inhibitor indoximod plus checkpoint inhibition for the treatment of patients with advanced melanoma – to be presented during the discussion session, "Melanoma/Skin Cancers," Monday, June 4, 2018, 4:45 PM – 6:00 PM CT

The complete text of abstracts selected for presentation at the ASCO (Free ASCO Whitepaper) 2018 Annual Meeting will be posted to the ASCO (Free ASCO Whitepaper) website on Wednesday, May 16th at 5pm ET.

"We are pleased to have the opportunity to present the results at ASCO (Free ASCO Whitepaper) from both of these Phase 2 trials of indoximod in combination therapies for patients with pancreatic cancer and advanced melanoma. We continue to gather data supporting the potential for our differentiated IDO pathway inhibitor, indoximod, in multiple combinations to improve the lives of patients with cancer," said Nicholas N. Vahanian, MD, President.

About Indoximod

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including anti-PD-1/PD-L1 agents, chemotherapy, radiation and cancer vaccines across multiple indications such as melanoma, pancreatic cancer and other malignancies.

GSK delivers Q1 sales of £7.2 billion, -2% AER, +4% CER
Total EPS 11.2p, -48% AER, -33% CER; Adjusted EPS 24.6p, -2% AER, +11% CER
Significant currency impact in the quarter reflecting movements in Sterling

On April 25, 2018 GlaxoSmithKline reported financial highlights for the first quarter of 2018 (Press release, GlaxoSmithKline, APR 25, 2018, View Source [SID1234525740]).

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• CER sales growth across all 3 businesses. Pharmaceuticals sales £4.0 billion -4% AER, +2% CER;
Vaccines £1.2 billion +7% AER, +13% CER; Consumer Healthcare £2.0 billion -3% AER, +2% CER
• Adjusted Group operating margin of 26.6%, down 0.2 percentage points AER, up 1.3 percentage points
CER. Pharmaceuticals 33.2%; Vaccines 27.4%; Consumer Healthcare 19.4%
• Total EPS 11.2p, -48% AER, -33% CER, reflecting revaluation of Consumer Healthcare business
following agreement to acquire full ownership
• Adjusted EPS 24.6p, -2% AER, +11% CER driven by continued operating and financial efficiencies
• Q1 free cash flow £324 million -50% primarily reflecting impact of £317 million Vaccine sales milestone
payment to Novartis
• 19p dividend declared for quarter. Continue to expect 80p for FY 2018
• Guidance for CER growth in Adjusted EPS for 2018 maintained
Novartis transaction
• Agreement reached with Novartis to acquire full ownership of Consumer Healthcare business for
$13 billion, subject to shareholder approval
Product and pipeline highlights
• Sales of Ellipta Respiratory products, £386 million +25% AER, +34% CER and Nucala £104 million
+76% AER, +86% CER. Landmark IMPACT data for Trelegy Ellipta published in NEJM. sNDA
approved in US and data submitted to European Medicines Agency to support expanded label.
OSMO study demonstrating Nucala improves asthma control in severe eosinophilic asthma patients
uncontrolled on Xolair presented at AAAAI
• Continued growth from dolutegravir-based HIV products, including new 2 drug regimen Juluca, with
sales of £964 million +15% AER, +23% CER. Positive CHMP opinion received for Juluca in Europe
• Shingrix sales of £110 million; approved in Europe and Japan (23 March)

Emma Walmsley, Chief Executive Officer, GSK said:
"GSK has continued to make good progress in the first quarter with sales growth on a CER basis across all
three businesses. We are strongly focused on commercial execution with encouraging starts for our most
recent new product launches, Shingrix, Trelegy and Juluca. This performance combined with continued cost
discipline has driven a further improvement in the Group’s Adjusted operating margin at CER. We also agreed
to acquire full ownership of the Consumer Healthcare business during the quarter, delivering on one of our key
capital allocation priorities. This will help improve future cash generation and support capital planning for the
Group’s main priority to strengthen the Pharmaceuticals business and R&D pipeline.

2018 guidance
The Group expects to make continued progress in 2018, although the expectation for Adjusted EPS growth
is impacted by a number of factors including, in particular, uncertainties relating to the timing and extent of
potential generic competition to Advair in the US.
In the event that no substitutable generic competitor to Advair is introduced to the US market in 2018, the
Group continues to expect 2018 Adjusted EPS growth of 4 to 7% at CER. In the first quarter, the Group has
made continued progress, with encouraging performances from new launches, Shingrix, Trelegy and Juluca
and other new products, as well as agreeing the buyout of Novartis’ shareholding in the Consumer Healthcare
Joint Venture, subject to shareholder approval. However, the Group has also seen increased pricing and
competitive pressures in the US inhaled respiratory market in the first quarter, and GSK now expects a decline
in 2018 US Advair sales of around 30% at CER.
In the event of a mid-year introduction of a substitutable generic competitor to Advair in the US, the Group
expects full year 2018 US Advair sales of around £750 million at CER (US$1.30/£1), with Adjusted EPS
flat to down 3% at CER.
The effective tax rate for 2018 is expected to be approximately 19-20% of Adjusted profits after the impact
of US tax reform which is expected to benefit the Group effective tax rate by two to three percentage points.
GSK is not able to give guidance for Total results as it cannot reliably forecast certain material elements of
our Total results such as the future fair value movements on contingent consideration and put options. It
should be noted that contingent consideration cash payments are made each quarter primarily to Shionogi by
ViiV Healthcare which reduce the balance sheet liability and are hence not recorded in the income statement.
An explanation of the acquisition-related arrangements with ViiV Healthcare, including details of cash
payments to Shionogi, is set out on page 37.
If exchange rates were to hold at the closing rates on 31 March 2018 ($1.40/£1, €1.14/£1 and Yen 149/£1)
for the rest of 2018, the estimated negative impact on full-year 2018 Sterling turnover growth would be around
5% and if exchange gains or losses were recognised at the same level as in 2017, the estimated negative
impact on 2018 Sterling Adjusted EPS growth would be around 8%