On January 23, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 1,242 million in 2017. Net sales were USD 884 million in the U.S. and net sales in the rest of the world were USD 358 million (Press release, Genmab, JAN 23, 2018, View Source [SID1234523485]). Genmab receives royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

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DARZALEX was approved in the U.S. in November 2015, in Europe in May 2016 and in Japan in September 2017. Worldwide net sales of DARZALEX in 2016 were USD 572 million, resulting in royalty income of DKK 458 million to Genmab.

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 19, 2018 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported that Norman Michael Greenberg, Ph.D., Senior Vice President and Chief Scientific Officer, will deliver a presentation on the Company’s lead programs in immuno-oncology as part of the Immunotherapy Showcase during the 2018 Precision Medicine World Conference on Wednesday, January 24, 2018, at 1:45 PM PT in Mountain View, CA (Press release, Atreca, JAN 23, 2018, View Source [SID1234523488]).

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Dr. Greenberg’s talk, titled "Mining the Immunoresponsome: Anti-Cancer Antibodies from Elite Responder Patients", will take place in the Boole Room, Track 4, in the Computer History Museum.

On January 23, 2018 Skyhawk Therapeutics, Inc. ("Skyhawk"), a new private company focused on the discovery and development of small molecule therapeutics that correct RNA expression, reported the close of $8 million in seed funding led by major family and biotech investors, including Tim Disney, the Duke of Bedford, Alexandria Venture Investments, and other undisclosed private investors (Press release, Skyhawk Therapeutics, JAN 23, 2018, https://www.prnewswire.com/news-releases/skyhawk-therapeutics-launches-with-8-million-in-seed-financing-to-advance-its-novel-platform-and-portfolio-of-small-molecules-that-correct-rna-expression-300586378.html [SID1234551690]). Proceeds of the financing will advance Skyhawk’s portfolio of specific and selective small molecules that initially target RNA exon skipping, which drives a set of 50+ diseases that include both broad-based neurological conditions and previously "undruggable" oncogenes in cancer.

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"We are pleased be working with leading investors to advance our mission of revolutionizing disease treatment with small molecules that correct RNA expression," said founding investor and executive chairman of Skyhawk’s board of directors, Bill Haney. "The Skyhawk team has spent the last 12 months building an expansive intellectual property base covering its unique drug discovery tools and small molecule library portfolio. The company’s first drug candidate targets a set of exon-skipping-driven cancer indications, and we are focusing our energy on driving it into the clinic in 2019."

Initially, Skyhawk is targeting diseases driven by a type of RNA mis-splicing called "exon skipping," where key regions on the RNA are left out during the RNA splicing process. Skyhawk’s proprietary technology enables the rational design of small molecules that target specific binding pocket regions on RNA, using both sequence and structural specificity, at particular moments in the RNA splicing process. By doing so, they reverse the mis-splicing and treat the disease.

"The ability to use small molecule therapeutics to selectively target RNA and correct RNA expression is potentially transformative," said Catherine Nuccio of Alexandria Venture Investments. "The technology has now moved beyond proof of concept and is applicable in a range of diseases for the benefit of a broad base of patients. We are excited to seed and support the team that helped to develop the initial technology and its mechanisms."

There are 50+ known diseases driven by exon skipping, from broad based neurological conditions to major cancers, and hundreds more driven by similar forms of RNA mis-expression.

Skyhawk Founders and Board of Directors
Skyhawk founders and founding board of directors include:

William Haney, Skyhawk co-founder and executive chairman of the Skyhawk board of directors, and co-founder and CEO of Dragonfly Therapeutics. Bill is currently CEO of Dragonfly Therapeutics, a Boston-based biotech that develops novel first-in-class therapeutics targeted at natural killer (NK) cells and other cells of the innate immune system. He is an investor and entrepreneur, having started or helped start more than a dozen technology companies.
Kathleen McCarthy, Skyhawk co-founder and CEO. Kathleen is a leading expert in developing small molecules to target RNA splicing. As a pre-clinical scientist at the Spinal Muscular Atrophy (SMA) Foundation in New York and at Roche in Basel, Switzerland, Kathleen helped bring the first-ever small molecule therapeutic targeting mRNA-protein interactions to clinical trials in SMA. She is a co-inventor and co-author on numerous patents and publications describing small molecules that specifically and selectively target RNA expression.
Kevin Koch, Skyhawk founding board member, venture partner with OrbiMed Advisors, LLC and President and CEO of Edgewise Therapeutics. Dr. Koch was formerly SVP of Drug Discovery: Chemical and Molecular Therapeutics at Biogen, where he managed global drug discovery and immunology. He was the co-founder of Array BioPharma, where he oversaw the invention of over 20 clinical development candidates, and has held senior positions at Amgen Inc. and Pfizer Central Research.
Andrew Boyd, Skyhawk founding board member and Fidelity Head of Global Equity Capital Markets. Andrew is head of Global Equity Capital Markets at Fidelity Management & Research Company, where he leads the private equity investments across the Fidelity funds. In this role he has been at the forefront of technology development, and has been a leading investor in firms such as Uber, Snapchat and SpaceX.
Andrew Bedford, Skyhawk founding board member, technology investor and Duke of Bedford, England. Andrew currently manages a broad portfolio of London properties, and, as the 15th Duke of Bedford, England, serves as a British nobleman and peer. He is an investor and board member in numerous companies with 30+ years’ experience in international real estate and technology.
Skyhawk Founding Scientific Advisory Board
Skyhawk’s founding scientific advisory board (SAB) is comprised of scientists with expertise in RNA-based disease and neurological conditions, mechanisms of RNA splicing, alternative splicing regulation in cancer, DNA replication and RNA structural biology. Members include:

Friedrich Metzger, founding chairman of the Skyhawk scientific advisory board and former Head of Discovery Rare Diseases at Roche. Dr. Metzger is a leading scientist in RNA-based disease and neurological conditions. At Roche, Dr. Metzger spent 15 years running drug discovery programs for Alzheimer’s, ALS, Parkinson’s, Duchenne Muscular Dystrophy and Spinal Muscular Atrophy (SMA). He is the senior author on the Science and Nature papers describing the first small molecules that could specifically and selectively target RNA expression.
Jacqueline A. Lees, founding member of the Skyhawk scientific advisory board, Associate Director of the Koch Institute for Integrative Cancer Research, and Professor of Biology at MIT. Dr. Lees is a leading scientist in cancer cell cycle regulation and alternative splicing regulation in cancer. Her research focuses on metastasis and personalized medicine, and the genetic causes of cancer.
Adrian Krainer, founding member of the Skyhawk scientific advisory board, member of the American Academy of Arts & Sciences, and Professor at Cold Spring Harbor Laboratory. Dr. Krainer is a world expert on the role of mRNA splicing proteins in cancer, and neurological and rare diseases. His lab is leading the understanding of mechanisms of RNA splicing, and the means by which faulty splicing can be corrected.
Steven Bell, founding member of the Skyhawk scientific advisory board, Investigator at Howard Hughes Medical Institute, member of the National Academy of Sciences, and Professor of Biology at MIT. Dr. Bell is a leading scientist in the study of DNA replication, with an emphasis on how assembly of enzymes is regulated during the cell cycle to ensure genomic maintenance.
Frédéric Allain, founding member of the Skyhawk scientific advisory board and Professor/Head of the Institute of Molecular Biology and Biophysics at ETH, Zurich, Switzerland. Dr. Allain is a leading scientist in the role of RNA in disease and the use of NMR technology to elucidate the structure of protein RNA complexes. He and his team are expert in the use of biophysical tools to study protein RNA interactions and mRNA splicing regulation, with a focus on the segment of genetic diseases that originate from post-transcriptional misregulation of gene expression often caused by splicing, RNA editing or translation defects.
"Skyhawk’s founding team has unique depth of experience in this growing area of small molecule therapeutic development." said Tim Disney, founding investor in Skyhawk. "To support their mission we put together a long-term, science-focused group of investors, who share their humility in the face of this great opportunity, and a strong interest on getting drugs to patients, quickly."

On January 23, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas" ) reported that it has completed the acquisition of Mitobridge, Inc. ("Mitobridge"), and Mitobridge has become a wholly owned subsidiary of Astellas as of January 23, 2018 (U.S. Eastern Time) (Press release, Astellas Pharma US, JAN 23, 2018, View Source [SID1234523489]).

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Astellas and Mitobridge

By exercising the option right to acquire Mitobridge, Astellas paid $225 million1 to acquire 100% of the equity in Mitobridge. In addition, Mitobridge shareholders will be eligible for additional payments from Astellas that total up to $225 million2 depending on the progress of various programs in clinical development.

The transaction accelerates Astellas’ research and development in diseases associated with mitochondrial dysfunctions and will enable the delivery of innovative new treatment options to patients. At this point, Astellas will maintain the organization in Cambridge, MA, and retain the Mitobridge name as a division of Astellas.

Astellas is still reviewing the impact of the completion of the acquisition on its financial results for the fiscal year ending March 31, 2018.

(1) As Astellas is a shareholder in Mitobridge, the actual payment by Astellas to Mitobridge shareholders after adjustment based on the estimate of cash and cash equivalents etc. held by Mitobridge is $161.7 million. The amount is subject to further true-up based on actual numbers as of the closing date.

(2) As Astellas is a shareholder in Mitobridge, the actual payment by Astellas to Mitobridge shareholders will be $165.5 million.