On January 23, 2018 Johnson & Johnson (NYSE: JNJ) reported sales of $20.2 billion for the fourth quarter of 2017, an increase of 11.5% as compared to the fourth quarter of 2016 (Press release, Johnson & Johnson, JAN 23, 2018, View Source [SID1234523486]).

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Operational sales results increased 9.4% and the positive impact of currency was 2.1%. Domestic sales increased 9.8% (Press release, Johnson & Johnson, JAN 23, 2018, View Source [SID1234523486]). International sales increased 13.5%, reflecting operational growth of 9.0% and a positive currency impact of 4.5%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales for the fourth quarter of 2017 increased 4.2%, domestic sales increased 4.1% and international sales increased 4.3%.*

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Worldwide sales for the full-year 2017 were $76.5 billion, an increase of 6.3% versus 2016. Operational results increased 6.0% and the positive impact of currency was 0.3%. Domestic sales increased 5.4%. International sales increased 7.4%, reflecting operational growth of 6.6% and a positive currency impact of 0.8%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales for the full-year 2017 increased 2.4%, domestic sales increased 1.6% and international sales increased 3.3%.*

Net loss and diluted loss per share for the fourth quarter of 2017 were $10.7 billion and $3.99, respectively. Fourth-quarter 2017 net loss included after-tax intangible amortization expense of approximately $0.9 billion and a net charge for after-tax special items of approximately $14.6 billion. Included in these special items is a provisional amount of approximately $13.6 billion associated with the recent enactment of tax legislation.** Fourth-quarter 2016 net earnings included after-tax intangible amortization expense of approximately $0.3 billion and a net charge for after-tax special items of approximately $0.3 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $4.8 billion and adjusted diluted earnings per share were $1.74, representing increases of 9.5% and 10.1%, respectively, as compared to the same period in 2016.* On an operational basis, adjusted diluted earnings per share increased 5.7%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

Net earnings and diluted earnings per share for the full-year 2017 were $1.3 billion and $0.47, respectively. Full-year net earnings included after-tax intangible amortization expense of approximately $2.5 billion and a charge for after-tax special items of approximately $16.2 billion. Included in these special items is a provisional amount of approximately $13.6 billion associated with the recent enactment of tax legislation.** Full-year 2016 net earnings included after-tax intangible amortization expense of approximately $0.9 billion and a charge for after-tax special items of approximately $1.3 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the full-year of 2017 were $20.0 billion and adjusted diluted earnings per share were $7.30, representing increases of 6.8% and 8.5%, respectively, as compared to the same period in 2016.* On an operational basis, adjusted diluted earnings per share also increased 7.6%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

"Johnson & Johnson delivered strong adjusted earnings per share growth of 8.5% and total shareholder return of greater than 24% in 2017, driven by the robust performance of our Pharmaceutical business, while continuing to make investments in acquisitions, innovation and strategic partnerships to accelerate growth in each of our businesses," said Alex Gorsky, Chairman and Chief Executive Officer. "As we enter 2018 and look beyond, we are experiencing an incredible pace of change in health care. Johnson & Johnson is uniquely positioned to lead during this dynamic era and deliver innovative solutions for patients and consumers that drive sustainable, long-term growth. We are pleased with the passage of recent legislation modernizing the U.S. tax system, which enables Johnson & Johnson to invest in innovation at higher levels to help address the most challenging unmet medical needs facing health care today."

Mr. Gorsky continued, "I want to thank all of our talented colleagues for their commitment, passion and dedication to transforming the lives of patients and consumers worldwide."

The Company announced its 2018 full-year guidance for sales of $80.6 billion to $81.4 billion reflecting expected operational growth in the range of 3.5% to 4.5%. The Company also announced adjusted earnings guidance for full-year 2018 of $8.00 to $8.20 per share reflecting expected operational growth in the range of 6.8% to 9.6%.* Adjusted earnings guidance excludes the impact of after-tax intangible amortization expense and special items.

Segment Sales Performance
Worldwide Consumer sales of $13.6 billion for the full-year 2017 represented an increase of 2.2% versus the prior year, consisting of an operational increase of 1.3% and a positive impact from currency of 0.9%. Domestic sales increased 2.7%; international sales increased 1.9%, which reflected an operational increase of 0.4% and a positive currency impact of 1.5%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales decreased 0.5%, domestic sales decreased 0.7% and international sales decreased 0.3%*.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were negatively impacted by declines in the Baby Care and Oral Care businesses, mostly offset by growth in over-the-counter products, including TYLENOL analgesics and upper respiratory products, and NEUTROGENA beauty products.

Worldwide Pharmaceutical sales of $36.3 billion for the full-year 2017 represented an increase of 8.3% versus the prior year with an operational increase of 8.0% and a positive impact from currency of 0.3%. Domestic sales increased 6.7%; international sales increased 10.8%, which reflected an operational increase of 10.1% and a positive currency impact of 0.7%. Sales included the impact of the acquisition of Actelion Ltd. which was completed in June 2017 and contributed 4.2% to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 4.2%, domestic sales increased 3.1% and international sales increased 5.8%.* Worldwide operational sales growth was negatively impacted by approximately 1.8 points due to a positive adjustment of U.S. rebate accruals in the first half of 2016, which did not repeat in the first half of 2017.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by new products and the strength of core products. Strong growth in new products include DARZALEX (daratumumab), for the treatment of patients with multiple myeloma, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer and TREMFYA (guselkumab), for the treatment of adults living with moderate to severe plaque psoriasis.

Additional contributors to operational sales growth included STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, INVEGA SUSTENNA/XEPLION/TRINZA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer, and XARELTO (rivaroxaban), an oral anticoagulant, partially offset by declines in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, due to biosimilar entrants.

During the quarter, the U.S. Food and Drug Administration (FDA) approved JULUCA (rilpivirine and dolutegravir), the first, complete, single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection; a 10 mg once-daily dose of XARELTO (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism after completing at least six months of initial anticoagulation therapy; and SIMPONI ARIA (golimumab) for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis. The European Commission approved TREMFYA (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis and granted approval to broaden the existing marketing authorization for ZYTIGA (abiraterone acetate) plus prednisone / prednisolone to include the treatment of newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer.

Regulatory applications for approval were submitted to the FDA and European Medicines Agency to expand the current indication of DARZALEX (daratumumab) for use in combination with bortezomib, melphalan and prednisone, as a treatment for newly diagnosed patients with multiple myeloma ineligible for autologous stem cell transplantation. In addition, a supplemental New Drug Application was submitted to the FDA for two new XARELTO (rivaroxaban) vascular indications: reducing the risk of major cardiovascular (CV) events such as CV death, heart attack or stroke in patients with chronic coronary and/or peripheral artery disease (CAD/PAD), and for reducing the risk of acute limb ischemia in patients with PAD.

Also in the quarter, a worldwide collaboration and license agreement was executed with Legend Biotech, a subsidiary of GenScript Biotech Corporation, to develop, manufacture and commercialize a chimeric antigen receptor (CAR) T-cell therapy, LCAR-B38M, targeting BCMA for the treatment of multiple myeloma.

Worldwide Medical Devices sales of $26.6 billion for the full-year 2017 represented an increase of 5.9% versus the prior year consisting of an operational increase of 5.7% and a positive currency impact of 0.2%. Domestic sales increased 4.5%; international sales increased 7.1%, which reflected an operational increase of 6.7% and a positive currency impact of 0.4%. Sales included the impact of the acquisition of Abbott Medical Optics which contributed 4.5%, to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.5%, domestic sales were flat and international sales increased 3.0%.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by electrophysiology products in the Cardiovascular business; endocutters and biosurgicals in the Advanced Surgery business; ACUVUE contact lenses in the Vision Care business; and wound closure products in the General Surgery business, partially offset by declines in the Diabetes Care business and spine products in the Orthopaedics business.

On January 22, 2018 Sanofi and Bioverativ Inc., a biopharmaceutical company focused on therapies for hemophilia and other rare blood disorders, reported that they have entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Bioverativ for $105 per share in cash, representing an equity value of approximately $11.6 billion (on a fully diluted basis) (Press release, Sanofi, JAN 22, 2018, View Source [SID1234523419]). The transaction was unanimously approved by both the Sanofi and Bioverativ Boards of Directors.

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"With Bioverativ, a leader in the growing hemophilia market, Sanofi enhances its presence in specialty care and leadership in rare diseases, in line with its 2020 Roadmap, and creates a platform for growth in other rare blood disorders. Together, we have a great opportunity to bring innovative medicines to patients worldwide, building on Bioverativ’s success in driving new standards of care with its extended half-life factor replacement therapies," commented Olivier Brandicourt, Sanofi’s Chief Executive Officer. "Combined, we will continue to leverage our scientific know-how, disciplined focus and development expertise that best position us to drive value for our shareholders and create breakthrough treatments for patients."

Bioverativ Chief Executive Officer, John Cox, noted, "Bioverativ was created to bring meaningful progress to people living with hemophilia and other rare blood disorders, and I am extremely proud of the accomplishments we’ve made toward that mission over the past year. We have expanded upon the success of Eloctate and Alprolix, which are making a difference in the lives of people with hemophilia every day, and built a pipeline of novel programs for people with rare blood disorders. Sanofi brings proven capabilities and a global infrastructure, which we believe will help to more rapidly expand access to our medicines globally and further our mission of transforming the lives of people with rare blood disorders. Our Chairman, Brian Posner, our entire Board and I strongly believed our spin-off would create meaningful value for shareholders, and this transaction delivers tremendous value for the shareholders who have invested in and supported our mission."

Business EPS is a non-GAAP financial measure (see appendix to Sanofi quarterly financial release for definitions)
Creating a Leading Hemophilia Portfolio

With approximately $10 billion in annual sales and 181,0002 people affected worldwide, hemophilia represents the largest market for rare diseases and is expected to grow above 7%3 per year through 2022. Treatment options for patients are shaped by shifting standards of care worldwide and include prophylaxis and extended half-life products, and the development and adoption of innovative therapies.

Bioverativ’s extended half-life therapies, Eloctate [Antihemophilic Factor VIII (Recombinant), Fc Fusion Protein] and Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] for the treatment of hemophilia A and B, respectively, represented the first major advancements in the hemophilia market in nearly two decades when launched. In 2016, Bioverativ generated $847 million in sales and $41 million in royalties.

Bioverativ currently markets the two products in the United States, Japan, Canada and Australia, and plans to expand into additional geographies. The therapies are also commercialized in the European Union and other countries under a collaboration agreement.

Sanofi believes factor replacement therapy will remain the standard of care in hemophilia for many years due to excellent safety and its increasingly superior long-acting profile. Sanofi will be able to leverage Bioverativ’s clinical expertise and existing commercial platform to advance fitusiran, an investigational RNA interference (RNAi) therapeutic for hemophilia A and B, with or without inhibitors. Sanofi recently announced a restructuring of its rare disease alliance with Alnylam Pharmaceuticals, with Sanofi obtaining global development and commercialization rights to fitusiran.

Strengthening Sanofi’s Specialty Care Portfolio

One of the priorities of Sanofi’s 2020 roadmap is to "Reshape the Portfolio" and focus on areas where the company currently has, or can effectively build, a leadership position. The addition of Bioverativ supports this priority by adding to our portfolio a differentiated offering of innovative therapies and providing a platform for growth in rare blood disorders, which will expand our presence in specialty care, further strengthen our leadership position in rare diseases and meet the needs of the patient community.

Beyond its two marketed products, Bioverativ’s pipeline includes a program in Phase 3 testing for cold agglutinin disease, and early stage research programs and collaborations in hemophilia, and other rare blood disorders, including sickle cell disease and beta thalassemia. Sanofi’s R&D organization will support Bioverativ in bringing these important therapies to patients faster. Furthermore, Sanofi’s global presence, proven expertise and success in launching specialty medicines, and established footprint in key emerging markets will help Bioverativ fully capitalize on growth opportunities for Bioverativ’s current and future products.

Delivering Shareholder Value

The addition of Bioverativ is expected to drive meaningful value for Sanofi’s shareholders, with strong cash flows from Bioverativ’s growing products expected to increase Sanofi’s financial and operational scale. The acquisition is expected to be immediately accretive to Sanofi’s Business EPS in FY2018 and up to 5% accretive in FY2019. Sanofi is also projected to achieve ROIC in excess of cost of capital within three years. Sanofi expects to preserve its strong credit rating.

Source: WFH 2016, MRB 2016, ATHN 2016, Evaluate Pharma
Note that the total estimated population with hemophilia is larger at ~400,000 estimated patients versus ~181,000 identified patients

Source: WFH 2016, MRB 2016, ATHN 2016, Evaluate Pharma
Transaction Terms

Under the terms of the merger agreement, Sanofi will commence a tender offer to acquire all of the outstanding shares of Bioverativ common stock at a price of $105 per share in cash. The $105 per share acquisition price represents a 64 percent premium to Bioverativ’s closing price on January 19, 2018.

The consummation of the tender offer is subject to various conditions, including the tender of at least a majority of the outstanding Bioverativ shares, redelivery of a tax opinion delivered at signing, the expiration or termination of the waiting period under the Hart Scott Rodino Antitrust Improvements Act and receipt of certain other regulatory approvals, and other customary conditions. Following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with Bioverativ and the outstanding Bioverativ shares not tendered in the tender offer will be converted into the right to receive the same $105 per share in cash paid in the tender offer. The tender offer is expected to commence in February 2018.

Sanofi plans to finance the transaction with a combination of cash on hand and through new debt to be raised. The tender offer is not subject to any financing condition. Subject to the satisfaction or waiver of customary closing conditions, the transaction is expected to close within three months.

Lazard is acting as exclusive financial advisor to Sanofi. Guggenheim Securities and J.P. Morgan Securities LLC are acting as financial advisors to Bioverativ. Weil, Gotshal & Manges LLP is serving as legal counsel to Sanofi. Paul, Weiss, Rifkind, Wharton & Garrison LLP is serving as legal counsel to Bioverativ.

Conference Call

Sanofi will host a webcast live on Sanofi’s website at 2:00 pm CET/8:00 am EST on Monday, January 22, 2018. The webcast details and full presentation will be made available on Sanofi’s Investor Relations webpage.

On January 22, 2018 Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that company management will be participating in Noble Capital Markets’ Fourteenth Annual Investor Conference taking place January 29-30, 2018 at the W Hotel, Fort Lauderdale, Florida. James Caruso, president and chief executive officer of Cellectar Biosciences, will present a company overview and update on Monday, January 29, 2018 at 1:00 p.m. Eastern time (Press release, Cellectar Biosciences, JAN 22, 2018, View Source [SID1234523412]).

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Mr. Caruso’s presentation will be webcast live at noble.mediasite.com/mediasite/Play/bd87d408fdd34479a0030edf85b4af221d and will be accessible on the Events and Presentations section of the company’s website where it will be archived for a period of time.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The PDCTM platform provides selective delivery of a diverse range of oncologic payloads to cancerous cells, whether a hematologic cancer or solid tumor, the primary tumor, a metastatic tumor or cancer stem cells. The selective delivery of oncologic payloads allows for the modification of the payloads’ therapeutic window which may maintain or enhance drug potency while reducing the number and severity of adverse events. The PDC platform takes advantage of a metabolic pathway utilized by all tumor cell types in all stages of the tumor "cycle." This allows the PDC molecules to gain access to the intracellular compartment of the tumor cells and for the PDCs to continue to accumulate over time, which enhances drug efficacy. The PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens as are required by other targeted delivery platforms. In addition to the benefits provided by the mechanism of entry, PDCs offer the potential advantage of having the ability to be conjugated to molecules in numerous ways, thereby increasing the types of molecules selectively delivered via the PDC. The PDC platform possesses the potential for the discovery and development of the next generation of cancer-targeting agents.

On January 22, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that Novartis (SIX Swiss Exchange: NOVN) intends to transition Arzerra (ofatumumab) for the treatment of certain chronic lymphocytic leukemia (CLL) indications from commercial availability to limited availability via compassionate use programs in all markets around the world except the United States (Press release, Genmab, JAN 22, 2018, View Source [SID1234523372]). Novartis will work with regulatory authorities to establish compassionate use programs for patients outside the US currently being treated with Arzerra as an ongoing treatment, to ensure continuity of treatment for all patients who benefit from Arzerra. As a consequence, Novartis will pay Genmab a lump sum of USD 50 million as payment for lost potential milestones and royalties. This amount will be included in Genmab’s 2018 guidance which will be issued on February 21, 2018. Royalties will continue to be earned on net sales of Arzerra. Arzerra is marketed under a collaboration agreement between Genmab and Novartis.

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"Novartis’ intention to transition Arzerra to compassionate use programs in the non-US markets reflects the fact that many more drugs have become available for CLL over the last five years and that there is a low number of patients using Arzerra outside of the US market. The compassionate use programs will ensure that patients who benefit from Arzerra can remain on treatment. We welcome the continued commercial availability of Arzerra for US patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Patients accessing the compassionate use program will be offered continued treatment with Arzerra for as long as they benefit from it, free of charge.

Novartis intends to start the transition process as soon as a carefully structured plan has been agreed with the various regulatory authorities.

The two Phase III studies of ofatumumab currently ongoing in Relapsing Multiple Sclerosis and the study of Arzerra in indolent non-Hodgkin lymphoma will continue.

About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.

In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate, for use in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL, and for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. In the European Union, Arzerra is currently approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy and in combination with fludarabine and cyclophosphamide for adult patients with relapsed CLL. In more than 60 countries worldwide, including the United States and EU member countries, Arzerra is also currently indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.

Please consult the full European Summary of Product Characteristics and full US Prescribing information, including Boxed Warning, for all the labeled safety information for Arzerra.

Under the collaboration with Novartis, a subcutaneous formulation of ofatumumab is also being investigated in two Phase III clinical studies in relapsing multiple sclerosis.

Novartis has rights to develop ofatumumab in autoimmune indications, including multiple sclerosis.

On January 22, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will webcast its Quarterly Update Conference Call for the fourth quarter 2017 on Tues., Feb. 20 at 4:30 p.m. ET/1:30 p.m. PT (Press release, Halozyme, JAN 22, 2018, View Source [SID1234523415]). Dr. Helen Torley, president and chief executive officer, will lead the call. On the same date, Halozyme will release financial results for the fourth quarter and year-ended December 31, 2017 following the close of trading.

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The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the Investors page of www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The live call may be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 95494046.