(Filing, Annual, ImmunoGen, 2016, AUG 25, 2016, View Source [SID:1234514746])

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On August 25, 2013, Soligenix, Inc. (the "Company") reported it entered into an agreement with SciClone Pharmaceuticals, Inc. ("SciClone"), pursuant to which SciClone provided the Company with access to its oral mucositis clinical and regulatory data library in exchange for exclusive commercialization rights for SGX942 (dusquetide), a novel, first-in-class therapy being developed by the Company for the treatment of oral mucositis in patients with head and neck cancer, subject to the negotiation of economic terms (Filing, 8-K, Soligenix, AUG 25, 2016, View Source [SID:SID1234515114]).

On September 9, 2016, the Company and SciClone entered into an exclusive license agreement (the "License Agreement"), pursuant to which the Company granted rights to SciClone to develop, promote, market, distribute and sell SGX942 in the People’s Republic of China, including Hong Kong and Macau, as well as Taiwan, South Korea and Vietnam (the "Territory"). Under the terms of the License Agreement, SciClone will be responsible for all aspects of development, product registration and commercialization in the Territory, having access to data generated by the Company. In exchange for exclusive rights, SciClone will pay to the Company royalties on net sales, and the Company will supply commercial drug product to SciClone on a cost-plus basis, while maintaining worldwide manufacturing rights.

In connection with the execution of the License Agreement, the Company entered into a common stock purchase agreement (the "Purchase Agreement") with SciClone pursuant to which the Company sold 3,529,412 shares of the Company’s common stock, par value $0.001 per share ("Common Stock"), to SciClone for $0.85 per share, for an aggregate price of $3,000,000. As additional consideration for expanded territorial rights in South Korea, Taiwan and Vietnam, SciClone agreed to purchase the shares of Common Stock at a premium above the current market price, with the purchase price being equal to one hundred thirty five percent (135%) of the average trading price of the Common Stock over the ten trading days prior to September 9, 2016. As part of the transaction, the Company granted SciClone certain demand registration rights.

The Purchase Agreement is provided to give investors information regarding the agreements’ respective terms. It is not provided to give investors factual information about the Company or SciClone. In addition, the representations, warranties and covenants contained in the Purchase Agreement were made only for purposes of that agreement and as of specific dates, were solely for the benefit of the parties to that agreement, and may be subject to limitations agreed by the contracting parties, including being qualified by disclosures exchanged between the parties in connection with the execution of such agreement. The representations and warranties may have been made for the purposes of allocating contractual risk between the parties to the agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors are not third-party beneficiaries under the agreement and should not view the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or conditions of the Company.

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On August 25, 2016 argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, reported its second quarter business update and half year financial results for 2016, in accordance with IFRS as adopted by the European Union (Press release, arGEN-X, AUG 25, 2016, View Source [SID:1234514755]).

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The half year results will be discussed during a conference call and webcast presentation today at 3 pm CET / 9 am EDT. To participate in the conference call, please select your phone number below, and use the confirmation code 49998398. The webcast may be accessed on the homepage of the argenx website at www.argenx.com or by clicking here.

"This quarter was a seminal one for us as we made substantial progress against several very important corporate goals: advancing our clinical and other pipeline programs and in closing a significant financing with key U.S. institutional investors as well as entering into a strategic transaction with AbbVie for our oncology candidate AGRX-115. We believe these accomplishments have driven argenx forward to become a new and more substantial company with a full and mature clinical pipeline, an advanced platform and the financial and strategic support to derive value from them," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "During the quarter we announced data from our Phase 1 MAD and SAD studies of ARGX-113 which led to the selection of our Phase 2 dose and demonstrated the drug’s strong safety profile and its ability to rapidly reduce IgG levels in healthy volunteers. Our lead oncology candidate ARGX-110 showed further evidence of anti-tumor activity in T-cell lymphoma patients and is on track to announce top-line data in this expansion cohort by end of year. We are looking forward to executing on our strategic plan for the remainder of 2016 to bring ARGX-113 into two Phase 2 indications and to examine the breadth of potential for ARGX-110 as a monotherapy and a combination agent in TCL and AML."

SECOND QUARTER 2016

Announced initial results from its Phase 1 multiple ascending dose (MAD) study of ARGX-113 in healthy volunteers. The compound continues to show favorable safety and tolerability across multiple doses and dosing regimens with promising pharmacodynamics effects relating to speed, depth and duration of IgG reduction.
Published efficacy and safety data from its ARGX-111 Phase 1 expansion study in patients with MET amplified tumors in conjunction with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting (Chicago, USA). The data confirm ARGX-111 to have a favorable safety profile and to continue to show signs of anti-tumor activity.
Presented efficacy and safety data from its Phase 1 expansion study of ARGX-110 in patients with T-cell lymphoma (TCL) during an e-poster session at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress (Copenhagen, Denmark). The data from the Phase 1 expansion study show evidence of clinical and/or biological anti-tumor activity with ARGX-110 in highly refractory cutaneous TCL & peripheral TCL patients with confirmed overexpression of CD70.
Entered into placement agreements with several predominant U.S. institutional investors relating to the issue of a total of 2,703,000 new shares for an aggregate amount of €30,003,300. The transaction was led by MPM Oncology Impact Fund with participation from Aquilo Capital, Burrage Capital, DAFNA Capital, Perceptive Advisors and certain other existing and new institutional investors.
Announced collaboration with AbbVie to develop and commercialize ARGX-115. ARGX-115 is argenx’ preclinical-stage human antibody asset targeting the novel immuno-oncology target GARP, a protein believed to contribute to immunosuppressive effects of T-cells. argenx received an upfront payment of $40M.
FINANCIAL HIGHLIGHTS (as of 30 June, 2016) (compared to financial highlights as of 30 June 2015)

Operating income of EUR 7.0 million (30 June 2015: EUR 4.3 million).
Net loss of EUR 7.4 million (30 June 2015: EUR 7 million).
Cash position of EUR 108.7 million (cash, cash-equivalents and financial assets) allowing Company to pursue development of its product portfolio as planned.

On August 25, 2016Medtronic plc (NYSE: MDT) reported financial results for its first quarter of fiscal year 2017, which ended July 29, 2016 (Press release, Medtronic, AUG 25, 2016, View Source;p=RssLanding&cat=news&id=2197342 [SID:1234514731]).

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The company reported first quarter worldwide revenue of $7.166 billion, a decrease of 1 percent, or an increase greater than 5 percent on a constant currency, constant weeks (CCCW) basis. Foreign currency translation had a negative $7 million impact on revenue. The first quarter of fiscal year 2017 contained 13 weeks, one less week than the first quarter of fiscal year 2016. The extra week occurs every six years as a result of the company’s 52-53 week fiscal year calendar. While it is difficult to calculate an exact impact from the extra week, the company estimates that it resulted in an approximate $450 million benefit to revenue and $0.08 to $0.10 benefit to non-GAAP diluted earnings per share (EPS) in the first quarter of the prior fiscal year.
First quarter GAAP net income and diluted EPS were $929 million and $0.66, increases of 13 percent and 16 percent, respectively. As detailed in the financial schedules included through the link at the end of this release, first quarter non-GAAP net income and diluted EPS were $1.444 billion and $1.03, representing increases of approximately 11 to 14 percent and approximately 14 to 16 percent, respectively, on a CCCW basis.
U.S. revenue of $4.002 billion represented 56 percent of company revenue and decreased 3 percent, or increased in the low-single digits on a constant weeks basis. Non-U.S. developed market revenue of $2.231 billion represented 31 percent of company revenue and increased 2 percent, or increased in the mid-single digits on a CCCW basis. Emerging market revenue of $933 million represented 13 percent of company revenue and was flat, or increased in the low-double digits on a CCCW basis.
"Q1 was another strong quarter for Medtronic, where our diversified businesses and geographies delivered solid results," said Omar Ishrak, Medtronic chairman and chief executive officer. "In addition to our solid top- and bottom-line performance, we also continue to generate significant free cash flow, and we continue to strategically deploy our capital against our priorities of reinvesting with discipline in M&A and R&D, returning substantial cash to our shareholders, and deleveraging our balance sheet."
Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic & Peripheral Vascular (APV) divisions. CVG worldwide revenue of $2.518 billion decreased 2 percent, or increased in the mid-single digits on a CCCW basis, driven by strong, balanced growth across all three divisions.
CRHF revenue of $1.334 billion decreased 3 percent, or increased in the mid-single digits on a CCCW basis. The division outperformed the market in core implantables on the strength of the Amplia MRI(TM) and Compia MRI(TM) Quad CRT-D, Evera MRI ICD, and Micra TPS pacemaker. AF Solutions grew in the mid-thirties on a CCCW basis on the strength of the Arctic Front Advance cryoballoon and recent FIRE AND ICE clinical data. The Diagnostics business also had a solid quarter, growing in the low-double digits on a CCCW basis, on the continued global adoption of the Reveal LINQ insertable cardiac monitor.
CSH revenue of $762 million decreased 3 percent, or increased in the mid-single digits on a CCCW basis, driven by high-twenties growth on a CCCW basis in transcatheter aortic heart valves as a result of strong customer adoption of the CoreValve Evolut R. Coronary declined in the mid-single digits on a CCCW basis, but drug-eluting stents grew in the mid-single digits on a CCCW basis in markets outside the United States driven by Resolute Onyx(TM) in Europe and emerging markets.
APV revenue of $422 million increased 2 percent, or increased in the high-single digits on a CCCW basis, with high-single digit growth on a CCCW basis in the Aortic business, driven by the continued strength of the Endurant IIs aortic stent graft, the Heli-FX EndoAnchor System, and Valiant Captivia thoracic stent graft. The Peripheral Vascular business grew in the high-single digits on a CCCW basis, with strong above-market growth in drug-coated balloons, driven by the clinically differentiated IN.PACT Admiral DCB, which holds the leading market position in the U.S. and globally.
Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Solutions and the Patient Monitoring & Recovery (PMR) divisions. MITG worldwide revenue of $2.424 billion decreased 1 percent, or increased in the mid-single digits on a CCCW basis, another strong quarter for the group with above market growth.
Surgical Solutions revenue of $1.348 billion was flat, or increased in the mid-single digits on a CCCW basis, driven by high-single digit growth on a CCCW basis in Advanced Stapling and mid-single digit growth on a CCCW basis in Advanced Energy. Early Technologies grew in the high-single digits on a CCCW basis, led by strong growth in GI Solutions.
PMR revenue of $1.076 billion decreased 3 percent, or increased in the mid-single digits on a CCCW basis, driven by growth in Renal Care Solutions from the recent acquisition of Bellco. The division also returned to market with the Puritan Bennett(TM) 980 ventilator and Capnostream(TM) 20 capnography monitor, which had previously been under shipping holds.
Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Spine, Brain Therapies, Specialty Therapies, and Pain Therapies divisions. This is the first quarter RTG revenue is reported in its new four division structure. RTG worldwide revenue of $1.772 billion decreased 2 percent, or increased in the mid-single digits on a CCCW basis. Group results were driven by strong Brain Therapies and Specialty Therapies growth, as well as by continued improvement in U.S. Spine, offsetting declines in Pain Therapies, all on a CCCW basis.
In the Spine division, which now includes the Core Spine, BMP, and Kanghui businesses, revenue of $645 million decreased 6 percent, or was flat on a CCCW basis. The Core Spine business grew in the low-single digits in the U.S. on a constant weeks basis, in-line with the market, as a number of new products and focus on procedural innovation is driving improved results. BMP grew in the mid-single digits on a CCCW basis, with high-single digit growth in the U.S. on a constant weeks basis partially offset by the continued loss of InductOs(TM) sales in Europe as a result of a shipping hold.
In the Brain Therapies division, which now includes the Neurovascular, Brain Modulation, and Neurosurgery businesses, revenue of $489 million increased 6 percent, or increased in the low-double digits on a CCCW basis. All three businesses had strong quarters, with Neurovascular growing in the high-teens, Neurosurgery growing in the low-double digits, and Brain Modulation growing in the mid-single digits, all on a CCCW basis.
In the Specialty Therapies division, which now includes the Pelvic Health, Advanced Energy, and ENT businesses, revenue of $356 million increased 3 percent, or increased in the low-double digits on a CCCW basis. All three businesses delivered strong quarters, with Advanced Energy growing in the high-teens, and Pelvic Health and ENT both growing in the high-single digits, all on a CCCW basis.
In the Pain Therapies division, which now includes the Pain (Spinal Cord Stimulation and Drug Pumps) and Interventional Spine businesses, revenue of $282 million decreased 9 percent, or decreased in the low-single digits on a CCCW basis. After adjusting for the divestiture of our drug business, which occurred in the third quarter of fiscal year 2016, Pain Therapies revenue was flat on a CCCW basis. Spinal Cord Stimulation declined in the mid-single digits on a CCCW basis, as the business faced competitive pressures. Drug Pumps grew in the mid-single digits on a CCCW basis, as the business returned to growth following declines over the past year as a result of its April 2015 U.S. FDA consent decree. Interventional Spine grew in the low-single digits on a CCCW basis.
Diabetes Group
The Diabetes Group includes the Intensive Insulin Management (IIM), Diabetes Service & Solutions (DSS), and Non-Intensive Diabetes Therapies (NDT) divisions. Diabetes Group worldwide revenue of $452 million increased 2 percent, or increased in the high-single digits on a CCCW basis. The group had strong, broad-based performance across all three divisions.
IIM grew in the high-single digits on a CCCW basis, driven by continued strong sales in Europe and Asia Pacific of the MiniMed 640G System with the enhanced Enlite sensor and SmartGuard(TM) technology.
NDT grew in the mid-seventies on a CCCW basis, led by strong U.S. sales of the iPro2 Professional Continuous Glucose Monitor (CGM) technology with Pattern Snapshot.
DSS grew in the high-single digits on a CCCW basis as a result of solid growth of consumables, revenue from the company’s acquisition of Diabeter in Europe, and continued strong growth of the MiniMed Connect, which over 18,000 people with diabetes are now using to view their insulin pump and CGM information on a smartphone.
Revenue Outlook and EPS Guidance
The company today reiterated its fiscal year 2017 revenue outlook and EPS guidance. Consistent with the company’s long-term, mid-single digit constant currency revenue growth expectation, the company continues to expect fiscal year 2017 revenue growth to be in the range of 5 to 6 percent on a CCCW basis, which excludes the benefit of the extra selling week in the company’s first quarter of fiscal year 2016, as well as the estimated benefit from foreign currency in fiscal year 2017.
In addition, the company reiterated its diluted non-GAAP EPS guidance for fiscal year 2017. The company expects fiscal year 2017 diluted non-GAAP EPS growth in the range of 12 to 16 percent on a CCCW basis, which excludes the estimated negative impact of foreign currency translation, as well as the benefit from the extra selling week in the company’s first quarter of fiscal year 2016. This annual EPS growth range is consistent with the company’s long-term, double digit constant currency EPS growth expectation, and continues to imply fiscal year 2017 diluted non-GAAP EPS in the range of $4.60 to $4.70. Other than as noted, EPS guidance does not include charges or gains that would be recorded as non-GAAP adjustments to earnings during the fiscal year.
"We feel very good about our momentum to start our fiscal year, and we are confident in our ability to sustain this performance over the coming quarters," said Ishrak. "We also remain focused on fully understanding and leading the shift to value-based healthcare systems that reward value and patient outcomes over volume, and we continue to develop partnerships and insights into how we can utilize our expertise to play a role in this evolution. We feel the appropriate application of medical technology can help address inefficiencies and improve outcomes in healthcare delivery, driving new forms of value creation – for both our customers and our shareholders."