SeaSpine to Report First Quarter 2018 Financial Results on May 3, 2018

CARLSBAD, Calif., April 19, 2018 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today that it will release first quarter 2018 financial results after the close of trading on Thursday, May 3, 2018. The Company’s management team will host a conference call beginning at 1:30pm PT / 4:30pm ET to discuss the financial results and recent business developments.

Individuals interested in listening to the conference call may do so by dialing (877) 418-4766 for domestic callers or (614) 385-1253 for international callers, using Conference ID: 8167947. To listen to a live webcast, please visit the Investors section of the SeaSpine website at: www.seaspine.com.

The call will be archived until Thursday May 17, 2018. The audio archive can be accessed by calling (855) 859-2056 in the U.S. or (404) 537-3406 from outside the U.S. The passcode for the audio replay is 8167947.

About SeaSpine

SeaSpine is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery, complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete procedural solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Investor Relations Contact
Lynn Pieper
(415) 937-5402
ir@seaspine.com

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“Patch” May Help Recovery After Shoulder Surgery for Rotator Cuffs

Shoulder injury? Get “patched up” – literally, says renowned orthopedic surgeon and sports medicine and arthroplasty specialist, Kevin D. Plancher, MD, who is using advanced technology – an all-natural, biologic “patch” about the size of a postage stamp – to repair and heal a certain type of tendon tear in the rotator cuff.

“We find that patients with the patch recover successfully from surgery, and require less time to rehabilitate the injured shoulder, even those patients with diabetes and whom are overweight,” states Dr. Plancher, who founded New York and Connecticut-based Plancher Orthopaedics & Sports Medicine.

This patch helps resolve partial tears of rotator cuff tendons seen in many pro athletes and “weekend warriors”. It can also help large tears caused by injury or by the degeneration of shoulder tissue due to age,” Dr. Plancher says.

Developed by Rotation Medical, Inc., now distributed by Smith & Nephew, it is a “bio-inductive implant.” The patch is composed of collagen fibers from the Achilles tendons of bovine animals, including cows and sheep. Applied to the injured tendon arthroscopically with special instruments, the patch appears to foster new tissue growth that thickens and strengthens the tendon. Eventually, the implant “dissolves” and is absorbed by the body. The federal Food and Drug Administration cleared the way for the implant’s use in 2014.

Researchers are hoping this implant will be the “breakthrough” in rotator cuff repair, Dr. Plancher says. Initial clinical data involving 200 patients and presented at the May 2017 meeting of the Arthroscopy Association of North America indicated that use of the patch resulted in statistically significant improvement in overall shoulder function and pain following surgery. Patch patients generally reported feeling better in the first six months following their procedure than did patients who had undergone more traditional rotator cuff treatments after two years.

“As orthopedic surgeons, we have been searching for a new ‘gold standard’ – that would transform our approach to rotator cuff repair,” Dr. Plancher says. “Most perplexing has been the risk of an injured shoulder tendon re-tearing, actually pulling away from its sutures, in cases of large tears when the tendon has to be affixed to the bone.

Dr. Plancher’s enthusiasm is well founded. Rotator cuff injuries are common with approximately 4 million Americans suffering from a rotator cuff disorder, either due to injury or age, and more than 50 percent of those older than age 60 reportedly have some degree of rotator cuff tear.

The rotator cuff consists of a stabilizing system of four major tendons and muscles that keep the head of the upper arm bone in the shoulder socket, allowing the arm to be raised and rotated. Partial — or complete — tears of these tendons can occur from normal wear over time; repetitive use as occurs in certain sports, such as baseball or tennis, or in occupations like painting or carpentry; and even injury from falls or heavy lifting.

Symptoms of rotator cuff problems include a dull ache in the shoulder, arm weakness, difficulty in lifting or rotating an arm and disturbed sleep. Partial tendon tears, seen in many athletes can affect their careers and can degenerate and often become full thickness tears.

Of course, the best medicine is prevention. To minimize risk of rotator cuff injury, Dr. Plancher advises:

  •     Exercise regularly to keep muscles strong and flexible in and around the shoulder blades and on the backs of shoulders.
  •     Warm up muscles before engaging in sports and other vigorous activities.
  •     Avoid lifting – or trying to catch – large, heavy objects.
  •     Don’t keep arms raised or out from the side for long periods of time. If you must do so, take breaks and put a cold compress on the stressed shoulder several times daily.

Most importantly, if you have any of the above mentioned symptoms for a prolonged period of time make sure you seek medical attention from a fellowship trained shoulder surgeon.

Kevin D. Plancher, MD, MPH, is a board-certified orthopaedic shoulder surgeon, pioneer of shoulder procedures and the founder of Plancher Orthopaedics & Sports Medicine.

Plancher Orthopaedics & Sports Medicine is a comprehensive orthopaedics and sports medicine practice with offices in New York City and Greenwich, CT. http://www.plancherortho.com

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RTI Surgical Schedules First Quarter 2018 Earnings Call for May 3, 2018

April 19, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, today announced that it plans to release financial results for the first quarter 2018 on Thursday, May 3, 2018 prior to the market open.

RTI will host a conference call and simultaneous audio webcast to discuss first quarter results at 9:00 a.m. ET the same day. The conference call can be accessed by dialing (877) 383-7419 (U.S.) or (760) 666-3754 (International). The webcast can be accessed through the investor section of RTI’s website at www.rtix.com. A replay of the conference call will be available on RTI’s website for one month following the call.

About RTI Surgical, Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic and trauma procedures and are distributed in nearly 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements, gaining market share and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

Contacts

RTI Surgical, Inc.
Media Contact:
Molly Poarch, +1-224-287-2661
mpoarch@rtix.com
or
Investor Contact:
Nathan Elwell, +1-847-530-0249
nelwell@lincolnchurchilladvisors.com

 

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Spikes of Graphene Can Kill Bacteria on Knee & Hip Implants

By Chalmers University of Technology – 04.16.18

A tiny layer of graphene flakes becomes a deadly weapon and kills bacteria, stopping infections during procedures such as implant surgery. This is the findings of new research from Chalmers University of Technology, Sweden, recently published in the scientific journal Advanced Materials Interfaces.

Operations for surgical implants, such as hip and knee replacements or dental implants, have increased in recent years. However, in such procedures, there is always a risk of bacterial infection. In the worst-case scenario, this can cause the implant to not attach to the skeleton, meaning it must be removed.

Bacteria travel around in fluids, such as blood, looking for a surface to cling on to. Once in place, they start to grow and propagate, forming a protective layer, known as a biofilm.

A research team at Chalmers has now shown that a layer of vertical graphene flakes forms a protective surface that makes it impossible for bacteria to attach. Instead, bacteria are sliced apart by the sharp graphene flakes and killed. Coating implants with a layer of graphene flakes can therefore help protect the patient against infection, eliminate the need for antibiotic treatment, and reduce the risk of implant rejection. The osseointegration—the process by which the bone structure grow to attach the implant—is not disturbed. In fact, the graphene has been shown to benefit the bone cells.

Chalmers University is a leader in the area of graphene research, but the biological applications did not begin to materialise until a few years ago. The researchers saw conflicting results in earlier studies. Some showed that graphene damaged the bacteria, others that they were not affected.

“We discovered that the key parameter is to orient the graphene vertically. If it is horizontal, the bacteria are not harmed” said Ivan Mijakovic, Professor at the Department of Biology and Biological Engineering.

 

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Ortho Sales Partners Announces the Appointment of Chris Stewart as Senior Vice President and General Manager of Hospital Strategy

Ortho Sales Partners, the global leader in commercialization services for the orthopedic industry, is pleased to announce the addition of Chris Stewart to the companies executive team. Mr. Stewart is a very well regarded leader and innovator that brings an in-depth knowledge of the supplier, hospital and physician relationship. In addition to having a cross functional leadership role, Mr. Stewart will lead the organization and its clients in strategies related to hospital access and supply chain value analysis illustration as well as enhancing Ortho Sales Partners software and logistics platforms developed to optimize supply chain delivery and clinician user experience.

Prior to joining Ortho Sales Partners, Mr. Stewart was the Assistant Vice President and Business Unit Leader of Medical Device Management for HealthTrust. Mr. Stewart managed consulting services for hospital IDN memberships comprised of approximately 1,600 acute and 2,000 ASC facilities. He oversaw a team of orthopedic, spine, osteobiologic and cardiovascular specialists who worked with hospital clients to actively manage their clinically sensitive implant service lines. Using data as an asset, his team developed strategic roadmaps to help hospitals and physicians achieve financial and clinical alignment, so they could plan, not just react, to financial pressures and complex market changes.

Previously, Mr. Stewart served in sales and sales management roles for Stryker Corporation. He currently serves as an ambassador and advisor to the Princess Charlene of Monaco Foundation, which is committed to empowering children to lead fulfilling lives, helping to transform lives through sports and putting an end to drowning.

Mr. Stewart holds a bachelor’s degree in economics and business administration from the University of Tennessee, Knoxville. He has presented at numerous healthcare forums on topics that include physician engagement, clinical best practice, alternative service models for the OR, strategic alliance of GPOs, shifting reimbursement models, new technologies, changing population demographics and the future of supply chain delivery.

About his new role, Mr. Stewart said: “I am excited to be joining this team of accomplished industry thought leaders who share the same vision and passion for enhancing value within this ever-changing healthcare environment”

Kevin McGann, CEO of Ortho Sales Partners, said: “We are very pleased to announce the addition of Chris Stewart to our team at Ortho Sales Partners.  Chris is a well-respected healthcare executive, who has tremendous knowledge of the hospital networks, ambulatory surgery centers and group purchasing organizations.  His experience in creating value added programs, and the utilization of data to direct purchasing behaviors is a tremendous asset to manufacturers, healthcare providers and physicians across the entire industry”

_____________

About Ortho Sales Partners

Ortho Sales Partners has created a unique platform to help companies in any stage commercialize their products in a very efficient way. We have worked closely with many organizations and produced results that have profoundly impacted each client’s business.

Our services are geared to meet you where you are today and help your business grow by utilizing proven industry executives that bring you an objective analysis and recommendations going forward. Our market knowledge is based on current trends and competitive analysis from industry stalwarts from some of the highest growth companies.

Ortho Sales Partners’ headquarters are in Scottsdale, Arizona but we have several offices across the US. (http://www.orthosalespartners.com).

 

Additional Product Platforms

Surg.io (http://www.surg.io)

OrthoEx (http://www.orthoex.com)

The De Angelis Group (http://www.orthospinesearch.com)

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SpineGuard® Announces First Spinal Deformity Surgery in China with PediGuard® by Prof. Yong Qiu

April 18, 2018

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets instruments designed to secure the placement of surgical implants by bringing real-time digital technology into the operating room, announced today that Professor Yong QIU performed the first spinal deformity surgery in China with the PediGuard® device.

Pr. Yong QIU is the Chairman of Orthopedic Surgery at Nanjing Drum Tower Hospital, President of the Chinese Scoliosis Research Society, and Vice-President of the Chinese Association of Orthopedic Surgeons and one of the leading scoliosis surgeons in China. His spine center is the largest scoliosis center in China, performing around 600 scoliosis surgeries per year, the majority of which are among the most complex cases in China.

This surgery case demonstrates the ability of XinRong Medical to quickly bring to market PediGuard enabled surgeries with the most preeminent surgeons in China, and highlights Xinrong’s ability to assist leading foreign brands in navigating the local tendering and hospital approval process.

“PediGuard increases safety for better screw placement, reduces surgical time by 15%, decreases X-ray exposure for patients, surgeons and staff and also helps train the young surgeons. It is a very useful and convenient device that is effective without any other supplementary equipment for complex spine surgery, especially for spinal deformity cases,” said Professor Yong Qiu, Chairman of Orthopedic Surgery of Nanjing Drum Tower Hospital.

“It is an immense honor for SpineGuard that Professor Yong Qiu performed the first spinal deformity surgery in China with the PediGuard device to secure pedicle screw placement. Professor Yong Qiu, who was trained in France, is the most experienced surgeon for spinal deformity in China with over 3,000 spinal deformity surgeries to his credit,” added Patricia Lempereur, International Director of Sales and Marketing at SpineGuard.

“We are honored by the use of PediGuard for spinal deformity cases at the Nanjing Drum Tower Hospital, one of the world most famous hospitals for spinal deformity with over 9,000 cases since their opening. We look forward to extending our collaboration with Pr. Yong Qiu with the use of PediGuard technology in training junior surgeons in China for pedicular screw placementChina market is growing rapidly, with spine surgery cases expected to grow around in the mid double digits in next 5 years. XinRong covers 2600 hospitals in China. We have great confidence that with the wide application PediGuard by Chinese surgeons will continue to dramatically enhance surgery case outcomes,” concluded Christine Zhang, XinRong Medical Group’s CEO.

The event was also reported by Chinese television news program, watch here.

More information on the DSG® technology and surgeons’ testimonials here.

Next financial press release: 2018 Half-year revenue: July 11, 2018

About SpineGuard®

Founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 60,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

About XinRong Medical Group

XinRong Medical Group, a leader in medical technology, is dedicated to increasing patient affordability and providing the most advanced solutions for surgeons such that they can deliver the best patient care. XinRong Medical offers innovative solutions in orthopedic surgery, neurosurgery, reconstructive surgery, and minimally invasive therapy. Established in 2000 in Jiangsu Province, China, XinRong Medical was one of the first companies in China cleared by CFDA to manufacture Orthopedic Implants. In 2014, the Company received a strategic investment from The Blackstone Group (NYSE: BX). For additional information about XinRong Medical, please refer to our website www.XRBest.Com, or contact us directly at +86-512-58100828 or info@xrmed.com.

Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Stéphane Bette
Chief Executive Officer
Tel: +33 (0)1 45 18 45 19
s.bette@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Mathilde Bohin / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.eu

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Histogenics Corporation Announces the Appointment of Susan Washer to Its Board of Directors

WALTHAM, Mass., April 18, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies (RCTs) that may offer rapid-onset pain relief and restored function, today announced the appointment of Susan Washer to its Board of Directors.

“Having known and worked with Sue for over 15 years, we are extremely pleased to welcome her to Histogenics’ Board of Directors,” stated Garheng Kong, M.D., Ph.D., Chairman of the Board of Directors of Histogenics.  “We believe Sue’s experience in the growing area of cell and gene therapies combined with her expertise in the development of novel gene therapies make her an excellent choice for the Histogenics Board of Directors.”

“The Histogenics restorative cell therapy platform and the NeoCart product opportunity are compelling for patients and clinicians, and I’m excited to be joining the Board of Directors,” noted Sue Washer, President & Chief Executive Officer of Applied Genetic Technologies Corporation (AGTC).  “I look forward to contributing to the growth of Histogenics as it prepares for potential FDA submissions and commercialization and continues to broaden its product platform both internationally and in other potential therapeutic applications.”

Ms. Washer is the President and Chief Executive Officer of AGTC, where she has served in such capacity since March 2002 and as a member of its board of directors since November 2003. Ms. Washer was also AGTC’s Chief Operating Officer from October 2001 to March 2002. From June 1994 to October 2001, Ms. Washer led two entrepreneurial firms including serving as president and CEO of Scenic Productions and as the Founding Executive Director and then Business Advisor for the North Florida Technology Innovation Center, a public-private organization financing and providing services to entrepreneurial companies licensing STEM based technology from Florida universities.  Ms. Washer currently serves on the board of directors of Biotechnology Innovation Organization (BIO) and the Alliance for Regenerative Medicine. Previously, Ms. Washer served as chairman of the BioFlorida board and the Southeast BIO board and continues her involvement with both organizations as a member of their respective boards.

From October 1983 to June 1994, Ms. Washer served in various research and pharmaceutical management positions with Abbott Laboratories and Eli Lilly and Company. Ms. Washer received a B.S. in biochemistry from Michigan State University and an M.B.A. from the University of Florida.

About Histogenics Corporation

Histogenics (Nasdaq:HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use. Histogenics recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line, one-year superiority data in the third quarter of 2018. NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit www.histogenics.com.



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First Case for Augmented Shoulder Baseplate

By: Elizabeth Hofheinz, M.P.H., M.Ed., April 17, 2018

Zimmer Biomet Holdings, Inc., based in Warsaw, Indiana, has announced that the first surgical case utilizing its Comprehensive Augmented Baseplate was performed by John W. Sperling, M.D., an orthopedic surgeon at Mayo Clinic.

According to the company, “This newly cleared baseplate boasts a simplified circular design at three augment heights (3mm, 5mm and 7mm buildup), allowing for augment placement in any orientation to accommodate various unique bone anatomies. Its circular design also allows bone ingrowth into the rim of the baseplate for optimal fixation.”

“The Comprehensive Augmented Baseplate is a component of the Comprehensive Reverse Shoulder System, a next-generation reverse shoulder prosthesis engineered to offer high-quality intraoperative flexibility and clinically proven technologies.”

“The system aims to minimize the potential challenges of removing well-fixed humeral stems by allowing conversion to a reverse shoulder using any of the existing Comprehensive stems. Additionally, the Comprehensive Augmented Baseplate leverages Mayo Clinic’s patented methodology for the optimization of shoulder arthroplasty components developed by Dr. Sperling at Mayo Clinic, Rochester, Minn., to provide relevant sizing for a conservative approach to bone removal to preserve bone stock if a future revision procedure is necessary.”

 

READ THE REST HERE

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Johnson & Johnson Reports 2018 First-Quarter Results

NEW BRUNSWICK, N.J.April 17, 2018 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) today announced sales of $20.0 billion for the first quarter of 2018, an increase of 12.6% as compared to the first quarter of 2017. Operational sales results increased 8.4% and the positive impact of currency was 4.2%. Domestic sales increased 6.1%. International sales increased 19.9%, reflecting operational growth of 10.9% and a positive currency impact of 9.0%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 4.3%, domestic sales increased 1.3% and international sales increased 7.6%.*

Net earnings and diluted earnings per share for the first quarter of 2018 were $4.4 billion and $1.60, respectively. First-quarter 2018 net earnings included after-tax intangible amortization expense of approximately $1.0 billion and a charge for after-tax special items of approximately $0.3 billion. First-quarter 2017 net earnings included after-tax intangible amortization expense of approximately $0.2 billion and a charge for after-tax special items of approximately $0.4 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $5.6 billion and adjusted diluted earnings per share were $2.06, representing increases of 11.8% and 12.6%, respectively, as compared to the same period in 2017.* On an operational basis, adjusted diluted earnings per share also increased 5.5%.A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

“We are pleased with the strong and consistent performance delivered by our colleagues around the world, demonstrated by our sales and EPS growth in the first quarter,” said Alex Gorsky, Chairman and Chief Executive Officer. “Our Pharmaceutical business continues to deliver robust growth and we are pleased with the improvement in our Consumer business. In our Medical Devices businesses, we have areas of leadership and continue to make investments and portfolio choices to improve performance.”

Mr. Gorsky continued, “The U.S. tax legislation passed late last year is creating the opportunity for us to invest more than $30 billion in R&D and capital investments in the U.S. over the next four years, which is an increase of 15%.”

The Company increased its sales guidance for the full-year 2018 to a range of $81.0 to $81.8 billion, reflecting expected operational growth in the range of 4.0% to 5.0%. Additionally, the Company reaffirmed its adjusted earnings guidance for full-year 2018 to a range of $8.00 to $8.20 per share, reflecting expected operational growth in the range of 6.8% to 9.6%.

Segment Sales Performance
Worldwide Consumer sales of $3.4 billion for the first quarter 2018 represented an increase of 5.3% versus the prior year, consisting of an operational increase of 1.3% and a positive impact from currency of 4.0%. Domestic sales increased 1.6%, international sales increased 8.2%, which reflected an operational increase of 1.2% and a positive currency impact of 7.0%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 2.0%, domestic sales increased 1.6% and international sales increased 2.3%*.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by beauty products primarily NEUTROGENA, AVEENO, and Dr. Ci Labo, and international analgesics in over-the-counter products, partially offset by the negative impact of domestic baby care products.

Worldwide Pharmaceutical sales of $9.8 billion for the first quarter 2018 represented an increase of 19.4% versus the prior year with an operational increase of 15.1% and a positive impact from currency of 4.3%. Domestic sales increased 9.9%; international sales increased 33.1%, which reflected an operational increase of 22.5% and a positive currency impact of 10.6%. Sales included the impact of Actelion Ltd which contributed 7.6%, to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 7.5%, domestic sales increased 2.2% and international sales increased 15.3%.*

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 ZYTIGA  (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer, STELARA (ustekinumab) and international SIMPONI/SIMPONI ARIA (golimumab), biologics for the treatment of  a number of immune-mediated inflammatory diseases, XARELTO (rivaroxaban), an oral anticoagulant, and INVEGA SUSTENNA/XEPLION/TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults.

During the quarter, the U.S. Food and Drug Administration (FDA) approved an additional indication for ZYTIGA (abiraterone acetate), in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer and ERLEADA (apalutamide) an oral androgen receptor inhibitor for the treatment of patients with non-metastatic castration-resistant prostate cancer. In addition, the Committee for Medicinal Products for Human Use issued a positive opinion recommending marketing authorization for JULUCA (rilpivirine and dolutegravir), the first, single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 infection.

Also in the quarter, a marketing authorization application was submitted to the European Medicines Agency for apalutamide, an oral androgen receptor inhibitor for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer.

Worldwide Medical Devices sales of $6.8 billion for the first quarter 2018 represented an increase of 7.5% versus the prior year consisting of an operational increase of 3.2% and a positive currency impact of 4.3%. Domestic sales increased 2.2%; international sales increased 12.7%, which reflected an operational increase of 4.2% and a positive currency impact of 8.5%. Sales included the partial quarter impact of the recently acquired surgical vision business  which contributed 3.1%, to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.1%, domestic sales decreased 0.2% and international sales increased 2.4%.*

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

During the quarter, the acquisition of Orthotaxy S.A.S., a privately-held developer of software-enabled surgery technologies, including a differentiated robotic-assisted surgery was completed. In addition, the Company announced a binding offer from Platinum Equity, a private investment firm, to acquire its LifeScan business for approximately $2.1 billion, subject to customary adjustments.

Subsequent to the quarter, ACUVUE OASYS with Transitions received 510(k) clearance from the FDA and is indicated for vision correction and the attenuation of bright light.

Additionally, Johnson & Johnson plans to implement actions across its global supply chain that are intended to enable the company to focus resources and increase investments in critical capabilities, technologies and solutions necessary to manufacture and supply its product portfolio of the future, enhance agility and drive growth. The Company expects these supply chain actions will include expanding our use of strategic collaborations, and bolstering our initiatives to reduce complexity, improving cost-competitiveness, enhancing capabilities and optimizing our network.  Discussions regarding specific future actions are ongoing and are subject to all relevant consultation requirements before they are finalized.

In total, the Company expects these actions to generate approximately $0.6 to $0.8 billion in annual pre-tax cost savings that will be substantially delivered by 2022. The Company expects to record pre-tax restructuring charges of approximately $1.9 to $2.3 billion, which will be treated as a special item.

About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.

* Operational sales growth excluding the net impact of acquisitions and divestitures, as well as adjusted net earnings, adjusted diluted earnings per share and operational adjusted diluted earnings per share excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company’s website at www.investor.jnj.com. Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

Johnson & Johnson will conduct a conference call with investors to discuss this news release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website at www.investor.jnj.com. A replay and podcast will be available approximately two hours after the live webcast by visiting www.investor.jnj.com.

Copies of the financial schedules accompanying this press release are available at www.investor.jnj.com/historical-sales.cfm. These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, a pharmaceutical pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can be found on the company’s website at www.investor.jnj.com.

NOTE TO INVESTORS CONCERNING FORWARD-LOOKING STATEMENTS

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; increased scrutiny of the health care industry by government agencies. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.govwww.jnj.com or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

 

Johnson & Johnson and Subsidiaries

Supplementary Sales Data

(Unaudited; Dollars in Millions)

FIRST QUARTER

Percent Change

2018

2017

Total

Operations

Currency

Sales to customers by

segment of business

Consumer

    U.S.

$       1,436

1,414

1.6

%

1.6

    International

1,962

1,814

8.2

1.2

7.0

3,398

3,228

5.3

1.3

4.0

Pharmaceutical

    U.S.

5,354

4,872

9.9

9.9

    International

4,490

3,373

33.1

22.5

10.6

9,844

8,245

19.4

15.1

4.3

Medical Devices

    U.S.

3,161

3,092

2.2

2.2

    International

3,606

3,201

12.7

4.2

8.5

6,767

6,293

7.5

3.2

4.3

U.S.

9,951

9,378

6.1

6.1

International

10,058

8,388

19.9

10.9

9.0

Worldwide

$     20,009

17,766

12.6

%

8.4

4.2

 

 

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OrthoTrophix Will Present Data on Long-Term Clinical Benefit of TPX-100 in Mild to Severe Knee Osteoarthritis Patients at OARSI Annual Meeting 2018

OAKLAND, Calif.April 17, 2018 /PRNewswire/ — OrthoTrophix, Inc., a privately held biopharmaceutical company, announced today that the company plans to report long-term clinical benefits in mild to severe knee osteoarthritis (OA) patients who were treated with TPX-100 at the 2018 OARSI annual meeting (Liverpool, U.K.26-29 April 2018).

OrthoTrophix previously presented the results of a Phase 2 clinical study in which the company’s OA drug candidate, TPX-100 improved knee function and physical quality of life at 6 and 12 months after treatment compared with placebo (N=93). A follow-on protocol, TPX-100-4, assessed the same patient reported outcomes in subjects who participated in TPX-100-1. The average time from the initial TPX-100 treatment was 30 months, with a range of 28 – 35 months.  Exclusion criteria included knee surgery or investigational drugs for OA in the interim between TPX-100-1 and TPX-100-4.  Of the 93 subjects in TPX-100-1, 53 enrolled in TPX-100-4. Topline results of this follow-on study will be included in the poster session of the 2018 OARSI annual meeting under the abstract entitled “TPX-100 LEADS TO MARKED, SUSTAINED IMPROVEMENTS IN SUBJECTS WITH KNEE OSTEOARTHRITIS.”

The company’s Chief Medical Officer, Dawn McGuire, MD., FAAN stated, “The long-term follow-on study enrolled over half the TPX-100-1 subjects, despite being an observational study only. The sustained improvement in knee function for more than two years in knees injected with TPX-100  confirms our confidence in TPX-100 as a drug with the potential to modify the disease of knee osteoarthritis as patients actually experience it.”

About OrthoTrophix, Inc.

OrthoTrophix, Inc., based in Oakland, California, is a privately held biopharmaceutical company focused on the development and commercialization of revolutionary therapeutics for the treatment of diseases and conditions involving the hard tissues.  Founded by three co-founders in 2011, the primary focus of OrthoTrophix has been regeneration and repair of cartilage in the knee and other joints with its novel proprietary compounds which promote formation of new cartilage and bone tissues and thereby repair the respective defects.  OrthoTrophix has received over $30 million from its preferred stock financing and research and development revenues since its inception.

This press release contains “forward-looking” statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development and cannot be guaranteed. OrthoTrophix undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect OrthoTrophix’ business.

Company Contact
Yoshi Kumagai
President and CEO
Tel:  (510) 488-3824

 

SOURCE OrthoTrophix, Inc.

Related Links

http://www.orthotrophix.com

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