Shire reports strong Q2 2017 operating results and cash flow; updates full year guidance
Q2 product sales growth of 7% on a combined pro forma basis; generated $1.2 billion operating cash flow
Over-delivered Year 1 Baxalta integration cost synergies, recognizing $400 million vs $300 million target
Exploring strategic review of Neuroscience franchise, including potential of independent public listing
Significant pipeline progress with SHP643 (lanadelumab); Phase 3 topline data demonstrates potential to change treatment paradigm for patients with HAE; U.S. approval of MYDAYIS for patients with ADHD; September launch planned
August 3, 2017 - Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG) announces unaudited results for the three months ended June 30, 2017.
Flemming Ornskov, M.D., M.P.H., Shire Chief Executive Officer, commented:
"During the second quarter, we delivered strong top-line growth of 7% on a pro forma basis, generating product sales of $3.6 billion. Our Immunology franchise grew by 18%, and we saw significant contributions across our broad and diverse portfolio. Shire remains ahead of schedule to deliver at least $700 million in cost synergies from the Baxalta integration by Year 3. The Q2 performance resulted in strong operating cash flow of $1.2 billion and enabled us to reduce Non GAAP net debt by $880 million in the quarter.
"We also continue to drive the late-stage clinical pipeline. In Q2 we announced positive topline data from our Phase 3 pivotal trial of SHP643 in HAE, and anticipate submission of the BLA in late 2017 or early 2018. MYDAYIS, a once-daily treatment for patients with ADHD, received US FDA approval and will be launched in September.
"We are at an exciting inflection point, with both our rare disease and neuroscience businesses performing strongly and each having significant growth potential over the coming years. The strength and scale of our business provides us with the opportunity to further optimize our franchise portfolio - one of our key priorities communicated earlier this year. By year end, we expect to complete a formal evaluation of the full range of strategic options for the neuroscience franchise, including the potential for its independent public listing.
"As we enter the second half of 2017, we are focused on generating strong organic growth while continuing to deliver on our key priorities - launching more than 80 products globally by leveraging our expanded commercial platform, progressing our late-stage pipeline, integrating Baxalta, and paying down debt. We have updated our 2017 full year guidance and remain very confident about Shire's long-term prospects."
Financial Highlights
Q2 2017(1) | Growth(1) | Non GAAP CER(1)(2) | |
Product sales | $3,592 million | +55% | +56% |
Product sales excluding legacy Baxalta | $1,882 million | +7% | |
Total revenues | $3,746 million | +54% | +56% |
Operating income from continuing operations | $399 million | +315% | |
Non GAAP operating income(2) | $1,492 million | +53% | +54% |
Net income margin(3)(4) | 6% | 13ppc | |
Non GAAP EBITDA margin(2)(4) | 43% | 1ppc | |
Net income | $240 million | N/M | |
Non GAAP net income(2) | $1,135 million | +47% | |
Diluted earnings per ADS(5) | $0.79 | N/M | |
Non GAAP diluted earnings per ADS(2)(5) | $3.73 | +10% | +11% |
Net cash provided by operating activities | $1,223 million | +107% | |
Non GAAP free cash flow(2) | $1,064 million | +130% |
(1) Results include Baxalta Inc. (Baxalta) (acquired on June 3, 2016), unless otherwise noted. Percentages compare to equivalent 2016 period. (2) The Non GAAP financial measures included within this release are explained on pages 28 - 29, and are reconciled to the most directly comparable financial measures prepared in accordance with US GAAP on pages 22 - 24. (3) US GAAP net income as a percentage of total revenues. (4) Percentage point change (ppc). (5) Diluted weighted average number of ordinary shares 913 million.
Product sales growth
Earnings growth
· Generated Non GAAP earnings per ADS of $3.73, underscoring continued focus on commercial excellence and operating efficiency.
· Continued to progress Baxalta integration, while delivering $400 million in cost synergies in year 1 - exceeding our target of $300 million - which contributed to a Non GAAP EBITDA margin of 43% for the quarter; on-track to achieve at least $700 million in synergies by year 3.
Strong cash flow
· Strong operating cash flow enabled $880 million reduction in Non GAAP net debt since March 31, 2017; remain on-track to achieve our year-end debt target.
Product and Pipeline Highlights
Regulatory updates
· Received U.S. Food and Drug Administration (FDA) approval of MYDAYIS, a new once-daily treatment option for symptom control in Attention Deficit Hyperactivity Disorder (ADHD) patients 13 years and older.
· Granted European Union (EU) Conditional Marketing Authorization for NATPAR (Parathyroid Hormone) for the treatment of patients with Chronic Hypoparathyroidism.
· Received European Medicines Agency (EMA) validation of VEYVONDI [von Willebrand factor (Recombinant)] Marketing Authorization Application for treatment of von Willebrand Disease (VWD).
· Submitted Investigational New Drug (IND) application to FDA for gene therapy candidate SHP654 for the treatment of hemophilia A.
Clinical and business development updates
· Reported positive topline data for SHP643 (lanadelumab), which was acquired with Dyax Corp. (Dyax), an investigational treatment that reduced Hereditary Angioedema (HAE) monthly attack rate by 87% versus placebo in a Phase 3 26-week pivotal trial.
· Entered into an agreement with Parion Sciences to develop and commercialize SHP659 (formerly known as P-321), an investigational epithelial sodium channel (ENaC) inhibitor for the potential treatment of Dry Eye Disease in adults.
· Expanded broad antibody research platform through license agreement with Novimmune S.A. to develop and commercialize an innovative, differentiated bi-specific antibody in pre-clinical development for the treatment of hemophilia A and hemophilia A patients with inhibitors.
FINANCIAL SUMMARY - SECOND QUARTER 2017 COMPARED TO SECOND QUARTER 2016
Revenues
Operating results
Earnings per share (EPS)
Cash flows
Debt
OUTLOOK
Following the strong performance in the first half of the year, we are updating our guidance for 2017.
The guidance incorporates accelerated synergy capture as well as an updated view on our product sales, primarily due to a new generic LIALDA competitor. We have also revised our depreciation estimate to be $450 - $500 million, based on updates resulting from the Baxalta integration, and we have lowered our capital expenditure forecast to $800 - $900 million.
Non GAAP EPS has been upgraded by raising the midpoint of our guidance range by 10 cents to $15.00, driven by cost discipline and accelerated synergy capture.
The diluted earnings per ADS forecast assumes a weighted average number of 914 million fully diluted ordinary shares outstanding for 2017.
Our US GAAP diluted earnings per ADS outlook has been updated to reflect ongoing integration activities, which has accelerated the recognition of synergies, and the change in fair value of contingent consideration for SHP643 (lanadelumab) resulting from the positive topline Phase 3 results.
Full Year 2017 | US GAAP Outlook | Non GAAP Outlook(1) |
Total product sales | $14.3 - $14.6 billion | $14.3 - $14.6 billion |
Royalties & other revenues | $600 - $700 million | $600 - $700 million |
Gross margin as a percentage of total revenue(2) | 67.5% - 69.5% | 74.5% - 76.5% |
Combined R&D and SG&A | $5.3 - $5.5 billion | $4.9 - $5.1 billion |
Net interest/other | $500 - $600 million | $500 - $600 million |
Effective tax rate | ~7% | 16% - 17% |
Diluted earnings per ADS(3) | $5.65 - $6.05 | $14.80 - $15.20 |
(1) For a list of items excluded from Non GAAP Outlook, refer to pages 28 - 29 of this release.
(2) Gross margin as a percentage of total revenues excludes amortization of acquired intangible assets.
(3) See page 24 for a reconciliation between US GAAP diluted earnings per ADS and Non GAAP diluted earnings per ADS.
RECENT DEVELOPMENTS
Corporate Strategy
Shire to assess strategic options for its Neuroscience franchise
Business Development
Shire enters into a licensing agreement for Novimmune bi-specific antibody
Products
FIRAZYR for the treatment of HAE in Japan
VEYVONDI for the treatment of adults affected by VWD
MYDAYIS for the treatment of ADHD
INTUNIV for the treatment of ADHD in Japan
Pipeline
SHP654 for the treatment of hemophilia A
SHP643 for the treatment of HAE
SHP647 for the treatment of ulcerative colitis
SHP680 for the treatment of multiple neurological conditions
Board Changes
In accordance with Shire's normal succession planning, the Company announces that the following Non-Executive Directors will retire from the Board with effect from the conclusion of the 2018 Annual General Meeting ("AGM"):
Al Stroucken, Non-Executive Director, will assume the position of Chairman of the Remuneration Committee effective August 3, 2017. Anne Minto will continue to serve as a member of the Remuneration Committee to enable a period of transition until her retirement from the Board. Anne will fully support Al in the shareholder consultation process ahead of the publication of the new Directors' Remuneration Policy that will be put forward for shareholder approval at the 2018 AGM. The Board, supported by the Nomination & Governance Committee, will continue to evaluate Board and committee membership, including succession plans for the roles of Senior Independent Director and Chairman of the Science & Technology Committee, and will announce further changes once finalized.
Dividend
In respect of the six months ended June 30, 2017, the Board resolved to pay an interim dividend of 5.09 U.S. cents per Ordinary Share (2016: 4.63 U.S. cents per Ordinary Share).
Dividend payments will be made in Pounds Sterling to holders of Ordinary Shares and in U.S. Dollars to holders of ADSs. A dividend of 3.85(1) pence per Ordinary Share (2016: 3.51 pence) and 15.27 U.S. cents per ADS (2016: 13.89 U.S. cents) will be paid on October 20, 2017, to shareholders on the register as of the close of business on September 8, 2017.
Holders of Ordinary Shares are notified that, in order to receive UK sourced dividends via Shire's Income Access Share arrangements ("IAS Arrangements"), they need to have submitted a valid IAS Arrangements election form to the Company's Registrar, Equiniti, by no later than 5pm (BST) on September 22, 2017. Holders of Ordinary Shares are advised that:
Internet links to the newly formatted IAS Arrangements election forms can be found at:
http://investors.shire.com/shareholder-information/shareholder-forms.aspx
(1) Translated using a GBP:USD exchange rate of 1.3221.
ADDITIONAL INFORMATION
The following additional information is included in this press release:
Page | |
Overview of Second Quarter 2017 Financial Results | 9 |
Financial Information | 14 |
Non GAAP Reconciliations | 22 |
Notes to Editors | 25 |
Forward-Looking Statements | 26 |
Non GAAP Measures | 28 |
Trademarks | 29 |
For further information please contact:
Investor Relations | |||
Ian Karp | ikarp@shire.com | +1 781 482 9018 | |
Robert Coates | rcoates@shire.com | +44 1256 894874 | |
Media | |||
Lisa Adler | lisa.adler@shire.com | +1 617 588 8607 | |
Debbi Ford | debbi.ford@shire.com | +1 617 949 9083 |
Dial in details for the live conference call for investors at 14:00 BST / 9:00 EDT on August 3, 2017:
UK dial in: | 0808 237 0030 or 020 3139 4830 |
US dial in: | 1 866 928 7517 or 1 718 873 9077 |
International Access Numbers: | Click here |
Password/Conf ID: | 96350792# |
Live Webcast: | Click here |
The quarterly earnings presentation will be available today at 13:00 BST / 8:00 EDT on:
- Shire's IR Briefcase in the iTunes Store
OVERVIEW OF SECOND QUARTER 2017 FINANCIAL RESULTS COMPARED TO SECOND QUARTER 2016
Product sales increased 55% to $3,592 million (Q2 2016: $2,322 million), primarily due to the inclusion of a full quarter of legacy Baxalta sales in Q2 2017. Excluding legacy Baxalta, product sales increased 7%.
(in millions) | Total Sales Year on year growth | ||||||||||||||||
Product sales by franchise | U.S. Sales | International Sales | Total Sales | Reported | Non GAAP CER | ||||||||||||
HEMOPHILIA | $ | 383.1 | $ | 360.8 | $ | 743.9 | N/M | N/M | |||||||||
INHIBITOR THERAPIES | 76.1 | 144.6 | 220.7 | N/M | N/M | ||||||||||||
Hematology total | 459.2 | 505.4 | 964.6 | N/M | N/M | ||||||||||||
CINRYZE | 164.7 | 11.2 | 175.9 | +2 | % | +2 | % | ||||||||||
ELAPRASE | 39.8 | 121.2 | 161.0 | +5 | % | +5 | % | ||||||||||
FIRAZYR | 118.1 | 19.3 | 137.4 | +1 | % | +1 | % | ||||||||||
REPLAGAL | - | 122.1 | 122.1 | +3 | % | +6 | % | ||||||||||
VPRIV | 37.3 | 50.6 | 87.9 | -0 | % | +2 | % | ||||||||||
KALBITOR | 20.6 | - | 20.6 | +16 | % | +16 | % | ||||||||||
Genetic Diseases total | 380.5 | 324.4 | 704.9 | +2 | % | +3 | % | ||||||||||
IMMUNOGLOBULIN THERAPIES | 407.9 | 102.6 | 510.5 | N/M | N/M | ||||||||||||
BIO THERAPEUTICS | 75.9 | 96.3 | 172.2 | N/M | N/M | ||||||||||||
Immunology total | 483.8 | 198.9 | 682.7 | N/M | N/M | ||||||||||||
VYVANSE | 460.1 | 58.1 | 518.2 | +0 | % | +0 | % | ||||||||||
ADDERALL XR | 67.2 | 4.2 | 71.4 | -30 | % | -30 | % | ||||||||||
MYDAYIS | 15.7 | - | 15.7 | N/A | N/A | ||||||||||||
Other Neuroscience | 5.2 | 24.9 | 30.1 | -16 | % | -12 | % | ||||||||||
Neuroscience total | 548.2 | 87.2 | 635.4 | -3 | % | -2 | % | ||||||||||
LIALDA/MEZAVANT | 187.5 | 20.3 | 207.8 | +7 | % | +8 | % | ||||||||||
PENTASA | 83.3 | - | 83.3 | +14 | % | +14 | % | ||||||||||
GATTEX/REVESTIVE | 63.7 | 11.6 | 75.3 | +69 | % | +70 | % | ||||||||||
NATPARA | 34.5 | - | 34.5 | +73 | % | +73 | % | ||||||||||
Other Internal Medicine | 31.2 | 52.2 | 83.4 | -6 | % | -3 | % | ||||||||||
Internal Medicine total | 400.2 | 84.1 | 484.3 | +15 | % | +16 | % | ||||||||||
Oncology total | 45.8 | 16.7 | 62.5 | N/M | N/M | ||||||||||||
Ophthalmology total | 57.4 | - | 57.4 | N/A | N/A | ||||||||||||
Total product sales | $ | 2,375.1 | $ | 1,216.7 | $ | 3,591.8 | +55 | % | +56 | % | |||||||
Hematology
Hematology, acquired with Baxalta in June 2016, reported product sales of $965 million. Hematology includes sales of recombinant and plasma-derived hemophilia products (primarily factor VIII and factor IX) and inhibitor therapies. Pro forma Q2 2017 growth in Hematology was approximately 1%. U.S. sales growth in Hemophilia, which benefited from stocking in the quarter, was partially offset by overall hematology performance in our international markets due to the timing of large orders.
Genetic Diseases
Genetic Diseases product sales increased 2%. Growth was primarily driven by our lysosomal storage diseases (LSD) portfolio.
ELAPRASE sales increased by 5%, while REPLAGAL sales increased by 3%. Both products benefited from an increase in the number of patients on therapy.
Immunology
Immunology, acquired with Baxalta in June 2016, reported product sales of $683 million. Immunology includes sales of antibody-replacement immunoglobulin and bio therapeutics therapies. Pro forma Q2 2017 growth in Immunology was approximately 18% (20% at Non GAAP CER) as the franchise benefited from growth in both immunoglobulin therapies and bio therapeutics. The U.S. benefited from growth in demand for our subcutaneous portfolio. International experienced growth across most regions with some benefit due to the timing of large orders.
Neuroscience
Neuroscience product sales decreased 3%, primarily driven by ADDERALL XR.
ADDERALL XR sales decreased 30%, primarily due to additional generic competition since August 2016. VYVANSE sales growth was impacted by destocking in the second quarter of 2017 compared to stocking in the same period in the prior year.
MYDAYIS, approved by the FDA on June 20, 2017, contributed $16 million of product sales related to launch stocking.
Internal Medicine
Internal Medicine product sales increased 15%, with strong growth from GATTEX/REVESTIVE and NATPARA.
GATTEX/REVESTIVE and NATPARA continued to perform well with sales increasing 69% and 73%, respectively, primarily due to an increase in the numbers of patients on therapy.
During Q2 2017, a generic version of LIALDA was approved by the FDA; Shire expects generic competition to negatively impact future LIALDA product sales.
Oncology
Oncology, acquired with Baxalta in June 2016, reported sales of $63 million. Oncology includes sales of ONCASPAR and ONIVYDE, the latter of which was approved in the EU on October 18, 2016 and has contributed to international growth in 2017.
Ophthalmology
Ophthalmology product sales relate to XIIDRA, which was made available to patients starting on August 29, 2016. XIIDRA contributed $57 million of product sales with 13% prescription growth since Q1 2017.
Baxalta pro forma product sales growth
The following table presents Q2 2017 reported legacy Baxalta product sales compared with Q2 2016 pro forma legacy Baxalta sales.
(in millions) | Pro forma Year on year growth | ||||||||||||||||
Product sales by franchise | U.S. Sales | International Sales | Total Sales | Reported | Non GAAP CER | ||||||||||||
HEMOPHILIA | $ | 383.1 | $ | 360.8 | $ | 743.9 | +3 | % | +5 | % | |||||||
INHIBITOR THERAPIES | 76.1 | 144.6 | 220.7 | -7 | % | -5 | % | ||||||||||
Hematology total | 459.2 | 505.4 | 964.6 | +1 | % | +2 | % | ||||||||||
IMMUNOGLOBULIN THERAPIES | 407.9 | 102.6 | 510.5 | +19 | % | +20 | % | ||||||||||
BIO THERAPEUTICS | 75.9 | 96.3 | 172.2 | +18 | % | +20 | % | ||||||||||
Immunology total | 483.8 | 198.9 | 682.7 | +18 | % | +20 | % | ||||||||||
Oncology total | 45.8 | 16.7 | 62.5 | +18 | % | +20 | % | ||||||||||
Total | $ | 988.8 | $ | 721.0 | $ | 1,709.8 | +8 | % | +9 | % | |||||||
(in millions) | Year on year growth | ||||||||
Revenue | Reported | Non GAAP CER | |||||||
SENSIPAR royalties | $ | 46.4 | +30 | % | +31 | % | |||
ADDERALL XR royalties | 13.4 | +158 | % | +157 | % | ||||
FOSRENOL royalties | 12.1 | +6 | % | +7 | % | ||||
3TC and ZEFFIX royalties | 8.2 | -32 | % | -32 | % | ||||
Other royalties and revenues | 73.9 | +73 | % | +77 | % | ||||
Total royalties and other revenues | $ | 154.0 | +44 | % | +46 | % | |||
Royalties and Other Revenues increased 44%, primarily due to the inclusion of a full quarter of contract manufacturing revenue acquired with Baxalta.
Cost of sales
(in millions) | Q2 2017 | % of total revenues | Q2 2016 | % of total revenues | ||||||||||
Cost of sales (US GAAP) | $ | 1,108.9 | 30 | % | $ | 778.1 | 32 | % | ||||||
Expense related to the unwind of inventory fair value adjustments | (145.0 | ) | (280.7 | ) | ||||||||||
Depreciation | (67.0 | ) | (22.4 | ) | ||||||||||
Non GAAP cost of sales | $ | 896.9 | 24 | % | $ | 475.0 | 20 | % | ||||||
Cost of sales as a percentage of total revenues decreased to 30% primarily due to lower expense related to the unwind of inventory fair value adjustments.
Non GAAP cost of sales as a percentage of total revenues increased to 24%, primarily due to the impact of a full quarter of lower margin product franchises acquired with Baxalta.
R&D
(in millions) | Q2 2017 | % of total revenues | Q2 2016 | % of total revenues | ||||||||||
R&D (US GAAP) | $ | 542.4 | 14 | % | $ | 294.8 | 12 | % | ||||||
Impairment of IPR&D intangible assets | (20.0 | ) | (8.9 | ) | ||||||||||
Costs relating to license arrangements | (123.7 | ) | - | |||||||||||
Depreciation | (12.8 | ) | (5.8 | ) | ||||||||||
Non GAAP R&D | $ | 385.9 | 10 | % | $ | 280.1 | 12 | % | ||||||
R&D increased by $248 million, or 84%, primarily due to milestone and upfront payments associated with license arrangements, and the inclusion of a full quarter of Baxalta costs.
Non GAAP R&D increased by $106 million, or 38%, primarily due to the inclusion of a full quarter of Baxalta costs. Non GAAP R&D expense as a percentage of total revenues decreased 2 percentage points.
SG&A
(in millions) | Q2 2017 | % of total revenues | Q2 2016 | % of total revenues | ||||||||||
SG&A (US GAAP) | $ | 899.1 | 24 | % | $ | 675.3 | 28 | % | ||||||
Legal and litigation costs | (7.6 | ) | (1.6 | ) | ||||||||||
Depreciation | (40.9 | ) | (19.7 | ) | ||||||||||
Non GAAP SG&A | $ | 850.6 | 23 | % | $ | 654.0 | 27 | % | ||||||
SG&A increased by $224 million, or 33%, primarily due to the inclusion of a full quarter of Baxalta related costs and increased XIIDRA marketing costs.
Non GAAP SG&A increased by $197 million, or 30%, primarily due to the inclusion of a full quarter of Baxalta related costs and increased XIIDRA marketing costs. Non GAAP SG&A as a percentage of total revenues decreased 4 percentage points.
Amortization of acquired intangible assets
Shire recorded amortization of acquired intangible assets of $434 million (Q2 2016: $213 million). The increase is primarily related to amortization on the intangible assets acquired with the Baxalta transaction.
Integration and acquisition costs
In Q2 2017, Shire recorded integration and acquisition costs of $344 million. Integration costs of $193 million, primarily related to Baxalta, including employee severance and acceleration of stock compensation, third-party professional fees and expenses associated with facility consolidations. Additionally, integration and acquisition costs included a net charge of $151 million, relating to the change in fair value of contingent consideration, primarily related to SHP643 which was acquired from Dyax in 2016.
In Q2 2016, Shire recorded integration and acquisition costs of $363 million. Integration and acquisition costs related to the Baxalta and Dyax transactions were $417 million, and included costs relating to investment banking and other transaction-related fees, as well as integration costs related to employee severance and acceleration of stock compensation, and third-party professional fees. These costs were partially offset by a net credit of $58 million relating to the change in fair value of contingent consideration.
Other expense, net
(in millions) | Q2 2017 | Q2 2016 | ||||||||||
Other expense, net (US GAAP) | $ | (137.7 | ) | $ | (79.6 | ) | ||||||
Amortization of one-time upfront borrowing costs for Baxalta and Dyax | 1.7 | 25.9 | ||||||||||
Gain on sale of long term investments | (13.2 | ) | - | |||||||||
Non GAAP Other expense, net | $ | (149.2 | ) | $ | (53.7 | ) | ||||||
Other expense, net increased by $58 million, primarily due to higher interest expense incurred on borrowings used to fund the acquisitions of Dyax and Baxalta.
Non GAAP Other expense, net increased by $96 million, primarily due to higher interest expense as noted above.
Taxation
(in millions) | Effective tax rate | Effective tax rate | ||||||||||||
Q2 2017 | Q2 2016 | |||||||||||||
Income tax expense (US GAAP) | $ | (24.3 | ) | 9 | % | $ | 70.9 | (427 | %) | |||||
Tax effect of adjustments | (187.6 | ) | (215.8 | ) | ||||||||||
Non GAAP Income tax expense | $ | (211.9 | ) | 16 | % | $ | (144.9 | ) | 16 | % | ||||
The effective tax rate on US GAAP income in Q2 2017 was 9% (Q2 2016: -427%) and on a Non GAAP basis was 16% (Q2 2016: 16%).
The effective rate in Q2 2017 on US GAAP income from continuing operations is low primarily due to the combined impact of the relative quantum of profit before tax for the period by jurisdiction and the reversal of deferred tax liabilities from the Baxalta acquisition, as well as acquisition and integration costs in higher tax territories.
Discontinued operations
The loss from discontinued operations in Q2 2017 was $1 million, net of taxes, associated with the divested DERMAGRAFT business. The loss in Q2 2016 was $249 million, net of taxes of $101 million, primarily due to the establishment of legal contingencies related to the divested DERMAGRAFT business.
FINANCIAL INFORMATION
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