Thermo Fisher Scientific Reports Third Quarter 2017 Results

On October 25, 2017 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the third quarter ended September 30, 2017 (Press release, Thermo Fisher Scientific, OCT 25, 2017, View Source [SID1234521158]).

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Third Quarter 2017 Highlights

Reported revenue of $5.1 billion.
Reported GAAP diluted earnings per share (EPS) of $1.34.
Reported adjusted EPS of $2.31.
Launched four new electron microscopy systems for structural biology and materials science research, released the new iQ Series air-quality monitoring platform, and enabled the first FDA-approved gene therapy, which uses our proprietary magnetic bead technology.
Opened Precision Medicine Customer Experience Center in Guangzhou, China, to showcase our range of technologies and services for advancing personalized healthcare.
Completed acquisition of Patheon, adding leading contract development and manufacturing outsourcing services to significantly enhance our value proposition for biopharma customers.
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."

"Our team executed very well to deliver another excellent quarter, with strong performance on the top and bottom line," said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific.

"We also continued to set our company up for an even stronger future by successfully executing our growth strategy. Among the highlights in the quarter, we expanded our analytical instrument platforms for both life sciences and applied markets, and contributed to a groundbreaking achievement in gene therapy. In Asia-Pacific, we built on our industry-leading scale and depth of capabilities in China to help our customers advance precision medicine.

"We were also very pleased to close our acquisition of Patheon in late August. Two months into the integration, we’re even more excited about the new opportunities we have to help our pharma and biotech customers achieve their goals."

Casper concluded, "We’ve made great progress during the past nine months, and are in an excellent position to achieve our growth goals for the year."

Third Quarter 2017

Revenue for the quarter grew 14% to $5.1 billion in 2017, versus $4.5 billion in the third quarter of 2016. Organic revenue growth was 5%; acquisitions increased revenue by 8% and currency translation increased revenue by 1%.

GAAP Earnings Results

GAAP diluted EPS in the third quarter increased 13% to $1.34, versus $1.19 in the same quarter last year. GAAP operating income for the third quarter of 2017 grew to $636 million, compared with $541 million in the third quarter of 2016. GAAP operating margin was 12.4%, compared with 12.0% in the third quarter last year.

Non-GAAP Earnings Results

Adjusted EPS in the third quarter of 2017 rose 14% to $2.31, versus $2.03 in the year-ago quarter. Adjusted operating income for the third quarter of 2017 grew 13% compared with the same quarter last year. Adjusted operating margin was 22.9%, compared with 23.0% in the third quarter of 2016, reflecting the dilutive impact from the acquisition of Patheon.

2017 Guidance Update

Thermo Fisher is raising its 2017 revenue and earnings guidance to reflect the acquisition of Patheon, strong operational performance and a more favorable foreign exchange environment. The company is raising its revenue guidance to a new range of $20.50 to $20.66 billion versus its previous guidance of $19.71 to $19.89 billion. This would result in 12 to 13% revenue growth over the previous year. The company is raising its adjusted EPS guidance to a new range of $9.29 to $9.38, versus the $9.15 to $9.28 previously communicated, for 12 to 13% growth over 2016.

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 third quarter of 2017, Life Sciences Solutions Segment revenue grew 5% to $1.38 billion, compared with revenue of $1.31 billion in the third quarter of 2016. Segment adjusted operating margin increased to 32.8%, versus 29.6% in the 2016 quarter.

Analytical Instruments Segment

Analytical Instruments Segment results reflect the acquisition of FEI Company in September 2016. Revenue for the segment grew 32% to $1.19 billion in the third quarter of 2017, compared with revenue of $898 million in the third quarter of 2016. Segment adjusted operating margin increased to 21.6%, versus 21.2% in the 2016 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue grew 6% to $844 million in the third quarter of 2017, compared with revenue of $799 million in the third quarter of 2016. Segment adjusted operating margin was 25.9%, versus 26.8% in the 2016 quarter.

Laboratory Products and Services Segment

Laboratory Products and Services Segment results reflect the acquisition of Patheon in late August 2017. In the third quarter of 2017, Laboratory Products and Services Segment revenue grew 15% to $1.93 billion, compared with revenue of $1.67 billion in the third quarter of 2016. Segment adjusted operating margin was 12.6%, versus 14.3% in the 2016 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, 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, net of 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 2017, based on acquisitions closed through the end of the third quarter of 2017, our adjusted EPS will exclude approximately $2.85 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), 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, net of 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, October 25, 2017, at 8:30 a.m. Eastern time. To listen, dial (877) 201-0168 within the U.S. or (647) 788-4901 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, November 3, 2017.

YmAbs Raises $50 Million in Equity Financing

On October 25, 2017 Y-mAbs Therapeutics, Inc. (YmAbs), an immunotherapy company discovering and developing innovative treatments for patients with cancer, reported that it has closed a private placement among HBM Healthcare Investments and its current shareholders raising $50 million (Press release, Y-mAbs Therapeutics, OCT 25, 2017, View Source [SID1234521160]).

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YmAbs’ Founder, President and Head of Business Development and Strategy, Thomas Gad said, "We are very pleased to welcome HBM as a significant shareholder in YmAbs, together with our existing shareholders, who continue to show strong support and commitment to bringing breakthrough immunotherapies to children faced with advanced cancers and clear unmet medical needs. This new financing sets YmAbs in a strong financial position to further advance its late stage oncology pipeline."

Dr. Claus Møller, Chief Executive Officer further notes, "This funding is an important financial achievement for YmAbs, and enables us to focus on bringing our lead compounds, burtomab and naxitamab, through the final steps of the regulatory pathway towards approval."

Andreas Wicki, Chief Executive Officer of HBM Healthcare Investments added: "We are delighted to add YmAbs to our portfolio of promising healthcare companies. YmAbs’ approach to immunotherapy shows great promise and will further advance innovation and product development in the pediatric oncology field. YmAbs is a young and rapidly growing company that we are excited to support and to accompany on the way to further success."

UNITED THERAPEUTICS CORPORATION REPORTS
THIRD QUARTER 2017 FINANCIAL RESULTS

On October 25, 2017 United Therapeutics Corporation (NASDAQ: UTHR) reported its financial results for the third quarter ended September 30, 2017 (Press release, United Therapeutics, OCT 25, 2017, View Source [SID1234521159]).

"Our third quarter net revenues totaled $446 million," said Martine Rothblatt, Ph.D., United Therapeutics Chairman and Chief Executive Officer. "In addition, Orenitram’s third quarter net revenues grew 29%, as compared to the same period in the prior year, resulting in two consecutive quarters of greater than 20% net revenue growth for this product. This further confirms our belief in the organic growth opportunity of Orenitram, which is the only true oral prostacyclin analog therapy for the large and increasing number of pulmonary arterial hypertension (PAH) patients. We also continued to invest in our growing pipeline of late stage programs in cardiopulmonary diseases and oncology, including the initial enrollment of patients into our phase III DISTINCT study of dinutuximab in small cell lung cancer, and our SOUTHPAW study of Orenitram in patients with WHO Group 2 pulmonary hypertension associated with left heart failure. Finally, we have continued to invest in our regenerative medicine and organ manufacturing programs to ultimately find a cure for PAH and other end-stage organ diseases."

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3RD QUARTER RESULTS

GSK delivers Q3 sales of £7.8 billion, +4% AER, +2% CER (Press release, GlaxoSmithKline, OCT 25, 2017, View Source [SID1234521161]).

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Total EPS 24.8p, +49% AER, +46% CER; Adjusted EPS 32.5p, +3% AER, flat CER


Financial highlights



Sales growth in Pharmaceuticals and Consumer Healthcare; Vaccines sales flat


Pharmaceuticals sales £4.2 billion +3% AER, +2% CER; Vaccines £1.7 billion +5% AER, flat at CER; Consumer Healthcare £2.0 billion +5% AER, +2% CER


Improved Total operating margin of 23.9% (+4.9 points, including 0.2 points currency benefit) and EPS (24.8p), primarily reflecting reduced transaction-related charges related to valuations of Consumer Healthcare and HIV businesses


Improved Adjusted Group operating margin of 31.5% (+1.0 point, no currency effect) primarily reflecting leverage from sales growth, focus on costs and benefits of restructuring. Pharmaceuticals 34.0% (-0.3 points, no currency effect); Vaccines 41.3% (+1.6 points, including 0.3 points adverse currency effect); Consumer Healthcare 20.0% (+3.9 points, including 1.3 points currency benefit)


YTD free cash flow £1.6 billion (9 months 2016: £1.3 billion)


19p dividend declared for quarter. Continue to expect 80p for FY 2017


Guidance for 2017 Adjusted earnings per share growth maintained at 3% to 5% CER

Product and pipeline highlights



New product sales of £1.7 billion, +44% AER, +40% CER, driven by continued strong performance from Tivicay/Triumeq in HIV, Relvar/Breo Ellipta and Nucala in Respiratory and meningitis vaccines


Trelegy Ellipta approved in the US for COPD and positive opinion received in Europe. Positive results from landmark IMPACT study show benefits of Trelegy Ellipta in reducing COPD exacerbations compared to dual therapies


Shingrix vaccine for shingles approved in US and Canada


Phase III results for Nucala (mepolizumab) in COPD published in New England Journal of Medicine with regulatory filings planned for this year


In Oncology, CHMP PRIME designation granted for 2857916 (BCMA antibody-drug conjugate) for relapsed and refractory multiple myeloma and new data to be presented at an upcoming scientific conference; option exercised from Adaptimmune to develop T-cell therapy (NY-ESO-1) for multiple tumour types

OncoSec Announces Fourth Quarter and Year End Financial Results for Fiscal Year 2017

On October 25, 2017 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported financial results for the fourth quarter and fiscal year ended July 31, 2017 (Press release, OncoSec Medical, OCT 25, 2017, View Source [SID1234521172]).

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"We have made significant progress this past quarter in advancing the development of our lead clinical program, ImmunoPulse IL-12, which we believe could provide a meaningful clinical benefit to metastatic melanoma patients with limited or no treatment options," said Punit Dhillon, President and CEO of OncoSec. "Our organization remains focused on advancing our PISCES/KEYNOTE-695 registration-directed trial to address this significant unmet medical need through an innovative accelerated pathway."

Fourth Quarter 2017 and Recent Highlights

Program Highlights and Upcoming Milestones

Presented positive Phase 2 data with ImmunoPulse IL-12 as monotherapy and in combination with pembrolizumab at the 2017 9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research.
50% (11/22) BORR observed at 24 weeks (42.9% [9/21] achieved RECIST v1.1 BORR).
41% (9/22) complete responders (CR), 9% (2/22) partial responders (PR), and 9% (2/22) stable disease (SD) for a total disease control rate of 59% (38.1% [8/21] achieved RECIST v1.1 durable CR) in predicted anti-PD-1 non-responder melanoma patients at 24 weeks.
Comprehensive immune monitoring data demonstrated combination of ImmunoPulse IL-12 and pembrolizumab can convert "cold" tumors to "hot" tumors, priming a coordinated innate and adaptive immune response, suggesting a synergistic relationship with anti-PD-1.
Favorable safety profile with <10% SAE as ImmunoPulse IL-12 monotherapy or in combination with pembrolizumab.
Initiated global, open-label, registration directed clinical trial, PISCES/KEYNOTE-695, of ImmunoPulse IL-12 in combination with pembrolizumab.
Enrolling patients with unresectable metastatic melanoma who have progressed or are progressing on an anti-PD-1 therapy.
Global study in the U.S. and Australia.
ImmunoPulse IL-12 granted Fast Track and Orphan Drug Designation in the U.S.
Clinical trial collaboration and supply agreement with Merck (known as MSD outside the US and Canada); attained KEYNOTE status.
Anticipate initial data mid-2018.
Late breaking poster presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd 2017 Annual Meeting to be held in National Harbor, MD on November 8-12, 2017.
Additional abstract highlighting preclinical data from novel multi-gene expression platform.
Presented comprehensive immune monitoring data from the Phase 2 clinical trial demonstrating that ImmunoPulse IL-12 in combination with pembrolizumab is well-tolerated and yields clinically meaningful synergy in immunologically "cold" tumors at the 2nd World Congress on Electroporation and Pulsed Electric Fields in Biology, Medicine and Food & Environmental Technologies.
Corporate Highlights

Added industry veterans Dr. Annalisa Jenkins, MBBS, FRCP and Daniel J. O’Connor to the Board of Directors;
Initiated a Technology Access Program collaboration with Jounce Therapeutics; and,
Raised and obtained commitments for $8.1 Million in offerings priced at or above market price
Fourth Quarter and Year-End 2017 Financial Results

For the fourth quarter of fiscal 2017 and the fiscal year ended July 31, 2017, OncoSec reported a net loss of $5.8 million and $21.4 million, or $0.28 per share and $1.06 per share, respectively, compared to a net loss of $6.6 million and $26.9 million, or $0.39 per share and $1.63 per share, respectively, for the same period last year. The decrease in net loss for the year ended July 31, 2017, compared with the same period in 2016, resulted primarily from: i) a $2.2 million decrease in non-cash stock-based compensation expense caused by an overall lower stock price and the Company’s tender offer exchange in December 2016 of certain then-outstanding stock options for a lesser number of new stock options with a lower exercise price; ii) a $1.8 million decrease in the costs of our research and development programs caused by our refocusing of resources to our higher priority PISCES/KEYNOTE-695 clinical program; and, iii) a $1.4 million decrease in personnel costs due to reduced headcount.

There were no revenues for the fiscal years ended July 31, 2017 or July 31, 2016.

Research and development expenses were $3.3 million and $12.0 million for the fourth quarter of fiscal 2017 and the fiscal year ended July 31, 2017, respectively, compared to $3.6 million and $14.7 million for the same periods in 2016. General and administrative expenses were $2.6 million and $9.5 million for the fourth quarter of fiscal 2017 and the fiscal year ended July 31, 2017, compared to $3.0 million and $12.1 million for the same period in 2016.

At July 31, 2017, OncoSec had $11.4 million in cash and cash equivalents, as compared to $28.7 million of cash and cash equivalents at July 31, 2016. OncoSec expects these funds to be sufficient to allow it to continue to operate its business to the third calendar quarter of 2018.

About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study)

PISCES is a global, multicenter phase 2b, open-label trial of intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or "tavo") delivered by electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of intratumoral tavo plus electroporation in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).