News Article | December 24, 2016
CHICAGO, Dec. 23, 2016 /PRNewswire-USNewswire/ -- The Muscular Dystrophy Association today celebrated news of the U.S. Food and Drug Administration's decision to grant approval for nusinersen (brand name Spinraza), the first disease-modifying drug to treat the most common genetic cause of...
News Article | February 10, 2017
The corticosteroid Emflaza (deflazacort) is now approved by the U.S. Food and Drug Administration as treatment for Duchenne muscular dystrophy in patients aged 5 years old and above. Corticosteroids are a common treatment option for DMD around the world but this is the first time that the FDA has approved any drug in the class to treat the condition and also the first time that Emflaza was approved for any kind of use. The third major proof point in the Muscular Dystrophy Association's research program, Emflaza joins two other drugs approved for treating muscular dystrophy: Exondys 51 and Spinraza. "This approval follows decades of MDA researcher ... that was made possible by the hard work, dedication, and unwavering commitment of our donors and sponsors," said Steven M. Derks, MDA CEO and president. "We hope that this treatment option will benefit many patients with DMD," said Dr. Billy Dunn, Division of Neurology director at the FDA Center for Drug Evaluation and Research. The FDA also granted Emflaza priority review and fast track and orphan drug designations. The orphan drug designation comes with incentives to encourage and assist in drug development for rare diseases. Marketed by Illinois' Marathon Pharmaceuticals, Emflaza is available as tablets and oral suspension. Both forms were approved by the FDA. As an immunosuppressant and anti-inflammatory, Emflaza was shown to slow loss of muscle function and strength, maintain respiratory and cardiac function, and reduce incidence of scoliosis in DMD patients. More importantly, the drug results in less severe side effects typically experienced when using corticosteroids, scuh as bone mass loss, weight gain, behavioral issues, and glucose intolerance. The drug's effectiveness was observed in a clinical study involving 196 male patients between the ages of 5 and 15. All of the study participants had documented dystrophin gene mutation and had experience muscular weakness before 5 years old. By week 12, those given deflazacort had improved strength across various muscles and overall muscle strength ability was maintained until the study ended at week 52. Similar results were observed in another trial that lasted 104 weeks with 29 male patients but this experiment also showed that participants on deflazacort seemed to lose walking ability later than those given placebo. The most common of muscular dystrophies, DMD occurs as the result of the lack of dystrophin, a protein that aids in keeping muscle cells together. Symptoms first appear typically at 3 to 5 years old, worsening over time. DMD commonly manifests in individuals without known family histories of the condition and mainly affects boys. It is said that the condition occurs in about one in every 3,600 male infants across the globe. People diagnosed with DMD experience progressive loss of ability to do activities independently, often requiring wheelchair use by the time they hit their early teen years. As the condition progresses, chances of life-threatening conditions developing involving the respiratory system and the heart grow. Life expectancy and disease severity vary but many patients usually succumb to DMD in their 20s or 30s. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.
News Article | November 7, 2016
CAMBRIDGE, Mass. & CARLSBAD, Calif.--(BUSINESS WIRE)--Biogen (NASDAQ:BIIB) and Ionis Pharmaceuticals (NASDAQ:IONS) announced that SPINRAZATM (nusinersen), an investigational treatment for spinal muscular atrophy (SMA), met the primary endpoint at the interim analysis of CHERISH, the Phase 3 study evaluating SPINRAZA in later-onset (consistent with Type 2) SMA. The analysis found that children receiving SPINRAZA experienced a highly statistically significant improvement in motor function compared to those who did not receive treatment. SPINRAZA demonstrated a favorable safety profile in the study. “ These results, along with our successful trial in infantile-onset SMA, reinforce the potential of SPINRAZA to benefit a broad range of SMA patients,” said Michael Ehlers, M.D., Ph.D., executive vice president, head of Research and Development at Biogen. “ We will make regulators around the globe aware of this data and will continue working closely with them to bring SPINRAZA to families affected by SMA as quickly as possible.” Biogen is preparing for the potential launch of SPINRAZA in the U.S. possibly as early as the end of 2016 or the first quarter of 2017. CHERISH is a fifteen-month study investigating SPINRAZA in 126 non-ambulatory patients with later-onset SMA (consistent with Type 2), including patients with the onset of signs and symptoms at greater than 6 months and an age of 2 to 12 years at screening. Results from the primary endpoint of the pre-specified interim analysis demonstrated a difference of 5.9 points (p= 0.0000002) at 15 months between the treatment (n=84) and sham-controlled (n=42) study arms, as measured by the Hammersmith Functional Motor Scale Expanded (HFMSE). From baseline to 15 months of treatment, patients who received SPINRAZA achieved a mean improvement of 4.0 points in the HFMSE, while patients who were not on treatment declined by a mean of 1.9 points. The HFMSE is a reliable and validated tool specifically designed to assess motor function in children with SMA, and a change of three points or greater in the HFMSE has previously been identified as clinically meaningful. Data from the other endpoints analyzed were consistently in favor of children who received treatment. SPINRAZA demonstrated a favorable safety profile. The majority of the adverse events were considered to be either related to SMA disease, common events in the general population, or events related to the lumbar puncture procedure. No patients discontinued the study. With the positive interim analysis, the CHERISH study will be stopped and participants will be able to transition into the SHINE open-label extension study to receive SPINRAZA. Full study results will be presented at future medical congresses. “ These data further validate the potential of SPINRAZA as a treatment for patients with SMA,” said B. Lynne Parshall, chief operating officer of Ionis Pharmaceuticals. “ We are grateful to all the families and clinicians who have participated in all of the SPINRAZA studies. Without their commitment and support, this program would not have been able to progress so quickly.” The U.S. Food and Drug Administration (FDA) recently accepted the company’s New Drug Application (NDA) for SPINRAZA as a treatment for SMA and communicated they plan to act early on the NDA under an expedited review. Additionally, the European Medicines Agency (EMA) recently validated Biogen’s Marketing Authorization Application (MAA) in the EU. The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted Accelerated Assessment status and the FDA granted Priority Review to SPINRAZA. Biogen is initiating regulatory filings in other countries in the coming months. Biogen initiated a global expanded access program (EAP) in infantile-onset SMA earlier this year. The company will continue to explore where and when the EAP may be broadened to include patients with later-onset SMA (consistent with Type 2). SPINRAZA has been studied in both presymptomatic and symptomatic patients with SMA including patients likely to develop or diagnosed with SMA Types 1, 2, and 3. The SPINRAZA Phase 3 program is comprised of two registrational studies, ENDEAR and CHERISH. ENDEAR is a thirteen-month study investigating SPINRAZA in 122 patients with infantile-onset SMA, including patients with the onset of signs and symptoms of SMA at up to six months of age. The endpoint pre-specified for the interim analysis of the study evaluated the proportion of motor milestone responders from the motor component of the Hammersmith Infant Neurological Examination (HINE). Given the results of the positive interim analysis, the ENDEAR study is being stopped and participants are able to transition into the SHINE open-label study, in which all patients will receive SPINRAZA. Additionally, the SHINE open-label extension study for patients who previously participated in ENDEAR or CHERISH is open and is intended to evaluate the long-term safety and tolerability of SPINRAZA. Two additional Phase 2 studies, EMBRACE and NURTURE, were designed to collect additional data on SPINRAZA. EMBRACE is studying a small subset of patients with infantile or later-onset SMA who do not meet the age and other criteria of ENDEAR or CHERISH. NURTURE is an open-label, ongoing study in pre-symptomatic infants who are up to six weeks of age at time of first dose to determine if treatment before symptoms begin would prevent or delay the onset of SMA symptoms. An interim analysis of NURTURE showed that infants treated for up to one year with SPINRAZA achieved motor milestones in timelines more consistent with normal development than what is observed in the natural history of patients with Type 1 SMA. Three infants experienced adverse events considered possibly related to SPINRAZA, all of which resolved. In addition, no infants have discontinued or withdrawn from the study and no new safety concerns have been identified. NURTURE is currently active and enrolling. All studies are being conducted on a global scale. Spinal Muscular Atrophy (SMA) is characterized by loss of motor neurons in the spinal cord and lower brain stem, resulting in severe and progressive muscular atrophy and weakness. Ultimately, individuals with the most severe type of SMA can become paralyzed and have difficulty performing the basic functions of life, like breathing and swallowing. Due to a loss of, or defect in the SMN1 gene, people with SMA do not produce enough survival motor neuron (SMN) protein, which is critical for the maintenance of motor neurons. The severity of SMA correlates with the amount of SMN protein. People with Type 1 SMA, the most severe life-threatening form, produce very little SMN protein and do not achieve the ability to sit without support or live beyond 2 years without respiratory support. People with Type 2 and Type 3 produce greater amounts of SMN protein and have less severe, but still life-altering forms of SMA. Currently, there is no approved treatment for SMA. To support awareness and education in SMA, Biogen has launched Together in SMA in the United States. Together in SMA is a program created to provide informational materials and resources to the SMA community. Learn more at www.TogetherinSMA.com. SPINRAZA is an investigational, potentially disease-modifying therapy for the treatment of SMA that was discovered and developed by Ionis Pharmaceuticals, a leader in antisense therapeutics. SPINRAZA is an antisense oligonucleotide (ASO) that is designed to alter the splicing of SMN2, a gene that is nearly identical to SMN1, in order to increase production of fully functional SMN protein.7 ASOs are short synthetic strings of nucleotides designed to selectively bind to target RNA and regulate gene expression. Through use of this technology, SPINRAZA has the potential to increase the amount of functional SMN protein in infants and children with SMA. Both the U.S. and EU have granted SPINRAZA Orphan Drug status. Additionally, both the U.S. and EU regulatory agencies have granted special status to SPINRAZA, including Fast Track Designation and Priority Review in the U.S. and Accelerated Assessment in the EU. Biogen exercised its option to worldwide rights to SPINRAZA in August 2016. Biogen and Ionis Pharmaceuticals acknowledge support from the following organizations for SPINRAZA: Cure SMA, Muscular Dystrophy Association, and SMA Foundation, intellectual property licensed from Cold Spring Harbor Laboratory and the University of Massachusetts Medical School. Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For more information, please visit www.biogen.com. Follow us on Twitter. Ionis is the leading company in RNA-targeted drug discovery and development focused on developing drugs for patients who have the highest unmet medical needs, such as those patients with severe and rare diseases. Using its proprietary antisense technology, Ionis has created a large pipeline of first-in-class or best-in-class drugs, with over a dozen drugs in mid- to late-stage development. Drugs currently in Phase 3 development include volanesorsen, a drug Ionis is developing and plans to commercialize through its wholly owned subsidiary, Akcea Therapeutics, to treat patients with either familial chylomicronemia syndrome or familial partial lipodystrophy; IONIS-TTR , a drug Ionis is developing with GSK to treat patients with all forms of TTR amyloidosis; and SPINRAZA (nusinersen), a drug Ionis is developing with Biogen to treat infants and children with spinal muscular atrophy. Ionis' patents provide strong and extensive protection for its drugs and technology. Additional information about Ionis is available at www.ionispharma.com. This press release contains forward-looking statements, including statements relating to the potential safety and efficacy of SPINRAZA, clinical trial results, potential regulatory approval and the timing thereof, and planning for launch readiness. These statements may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Factors which could cause actual results to differ materially from our current expectations include: the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies or may fail to approve or may delay approval of SPINRAZA or grant marketing approval that is different than anticipated; and risks relating to the potential launch of SPINRAZA, including preparedness of healthcare providers to treat patients, the ability to obtain and maintain adequate reimbursement for SPINRAZA and other unexpected difficulties or hurdles. For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement. This press release includes forward-looking statements regarding Ionis' strategic relationship with Biogen and the development, activity, therapeutic potential, safety and commercialization of SPINRAZA. Any statement describing Ionis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Ionis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis’ programs are described in additional detail in Ionis’ annual report on Form 10-K for the year ended December 31, 2015, and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the Company. BIOGEN and the BIOGEN logo are registered trademarks of BIOGEN. SPINRAZATM is a trademark of BIOGEN. Ionis Pharmaceuticals™ is a trademark of Ionis Pharmaceuticals, Inc. Akcea Therapeutics™ is a trademark of Ionis Pharmaceuticals, Inc.
News Article | November 10, 2016
CALGARY, ALBERTA--(Marketwired - Nov. 9, 2016) - DIRTT Environmental Solutions Ltd. ("DIRTT" or the "Company") (TSX:DRT), a leading technology-enabled designer, manufacturer and installer of fully customized, prefabricated interiors, today announced its financial results for the three and nine-month periods ended September 30, 2016. This news release contains references to Canadian dollars and United States dollars. Canadian dollars are referred to as "$" and United States dollars are referred to as "US$". For the three months ended September 30, 2016 the Company reported: For the nine months ended September 30, 2016 the Company reported: "The third quarter represents the first time we have exceeded $70 million in revenue and highlights the growing momentum we are seeing in almost all of our industry segments," said Mogens Smed, DIRTT CEO. "Perhaps more notable is that the energy sector, which significantly reduced our growth in 2015 and 2016 was only 1% of our business in Q3. Our long-term strategies of diversifying into complementary industries such as healthcare and education and accelerating investment in new solutions and leading edge technology such as ICEreality™ are paying strong dividends." Scott Jenkins, President of DIRTT added, "While the energy sector has been a drag on our growth in the prior year and in 2016, we are encouraged that our other industry segments have generated growth in excess of 20% year-to-date and over the last 12 months on a consolidated basis. At the beginning of 2015, the energy sector represented approximately 28% of revenue; now that the challenges of the energy sector are largely behind us, we are confident that our overall growth will improve in 2017." Mogens Smed added, "As discussed previously we have increased our investment in our distribution partners along with adding strategic sales, marketing and business development resources during the year. These team members and our strategic programs focused on our partners are starting to support our growth prospects throughout North America and abroad. Conventional construction is faced with ever growing skilled labor shortages, continual quality issues, time delays and cost overruns. DIRTT on the other hand continues to set new standards for our customized, high quality solutions as the announcement of our reduction in manufacturing lead times demonstrates. Our growing list of clients understand that with DIRTT there truly is a better way to build." Appointment of Mr. Richard J. Haray to the Board of Directors DIRTT would like to welcome Mr. Richard J. Haray to the Board of Directors effective November 8, 2016. Mr. Haray brings a wealth of commercial real estate, procurement, marketing and legal expertise to DIRTT's Board and is currently Senior Vice President, Corporate Services of the Interpublic Group, one of the world's leading organizations of advertising agencies and marketing services companies with over 50,000 employees and 450 offices in 120 countries worldwide. Commenting on the addition of Mr. Haray to the Board of Directors, DIRTT Board Chair Steve Parry said, "Richard's vast real estate network and experience, as well as his role as a member of one of the world's pre-eminent marketing and advertising companies, will be tremendous assets to DIRTT. His interest in DIRTT speaks volumes as to his belief in our prospects and his ability to contribute to our goals as we move forward." Mr. Haray began his tenure at IPG in 1996 overseeing real estate and insurance. He played a key role in centralizing this function and getting IPG on a path to better service and significant cost savings. In October 2005, Mr. Haray took on the additional responsibility of corporate-wide global sourcing and procurement efforts. Prior to his tenure at IPG, Mr. Haray was Vice President and Lease Counsel of Rockefeller Center Management Corporation. Prior to Rockefeller Group, he held positions at both Shearman and Sterling and Willkie Farr & Gallagher as a Real Estate Associate. He is a life-long resident of New York City and currently sits on the Board of the Bryant Park Management Corporation, Regional Plan Association and Fordham University President's Council. Mr. Haray is a member of CoreNet, a corporate real estate professional organization and CRELC, a corporate leadership group focusing on current real estate issues and trends. Mr. Haray is also a board member of the James Lenox Association for the elderly and actively works on behalf of several New York-based charities, including the St. Francis Food Pantries, Muscular Dystrophy Association, and scholarship foundations benefiting Fordham and St. John's Universities. Mr. Haray received his BA from St. John's University and his JD Degree from St. John's University School of Law, where he served as Editor-in-Chief of the Law Review. Revenue increased by $9.5 million, or 15.2%, for Q3 2016 compared with Q3 2015. The increase was the result of a general increase in activity from small and medium-sized projects in Q3 2016, from a diverse range of industry segments. In addition, installations revenue in Q3 2016 increased by $1.8 million to $2.1 million, compared with $0.3 million in Q3 2015. During Q3 2016, revenue from energy represented 1% of total revenue as compared to 6% in Q3 2015. The impact to the Canadian dollar value of US revenue was negligible as the average US dollar decreased from 1.3087 from Q3 2015 to 1.3046 in Q3 2016. These decreases in revenue were more than offset by increases in other segments. Below is a breakdown of percentage revenue by sector for Q3 2016 versus Q3 2015: Revenue increased by $17.1 million, or 9.9%, for YTD 2016 compared with the same period in 2015. The 2015 period included revenue of $8.4 million from the previously announced US$30.0 million US energy sector contract, compared to nil during the 2016 period. This business was partially offset by the $4.3 million contribution (2% of total revenue) from the residential market during the 2016 period. The remainder of the increase in the 2016 period was the result of a general increase in activity from small and medium-sized projects, from a diverse range of industry segments. During YTD 2016 the energy industry represented only 4% of revenue whereas in 2015 it represented 12%. This decrease in revenue has been more than offset by increases in other industry segments. The stronger average US dollar versus the comparable period in 2015 (YTD 2016 - 1.3213; YTD 2015 - 1.2598) also increased the Canadian dollar value of US revenue which contributed to the higher revenue in the 2016 period. Below is a breakdown of percentage revenue by sector for YTD 2016 versus YTD 2015: Gross profit for Q3 2016 improved to $31.0 million from $27.8 million in Q3 2015, an increase of 11.4%. However, gross profit % slightly declined by 150 basis points to 43.3% from 44.8%. The decrease in gross profit % was due primarily to changes in product/service revenue mix, greater volatility in the timing of monthly production volumes, and a higher level of installations revenue. Adjusted gross profit for Q3 2016 improved to $31.7 million from $28.4 million for Q3 2015, an increase of 11.3%. However, adjusted gross profit % declined by 150 basis points to 44.3% from 45.8% for the same reasons discussed above with respect to gross profit. Gross profit for YTD 2016 improved to $82.3 million from $73.0 million for the same period in 2015, with gross profit % widening 110 basis points to 43.6% from 42.5%. Relatively steady timing of manufacturing volumes for most of the 2016 period, combined with a diverse project mix, contributed to the increase in gross profit % in 2016. Adjusted gross profit for YTD 2016 improved to $84.7 million from $75.2 million for the same period in 2015, with adjusted gross profit % widening 110 basis points to 44.9% from 43.8% for the same reasons discussed above with respect to gross profit. The higher US dollar to Canadian dollar average exchange rate (YTD 2016 - 1.3213; YTD 2015 - 1.2598) also contributed to increased gross profit and adjusted gross profit in YTD 2016, as the positive impact on US dollar revenue exceeded the negative impact on US dollar-based production costs. US dollar-based production costs include those costs incurred at our manufacturing facilities in Savannah, Georgia and Phoenix, Arizona. Additionally, some of our largest raw material costs incurred at all of our manufacturing facilities are also denominated in US dollars. Selling, general and administrative ("SG&A") % increased slightly by 30 basis points from 34.7% to 35.0% in Q3 2016 compared with Q3 2015. SG&A expenses increased by $3.5 million, or 16.2%, for Q3 2016 compared with Q3 2015. The increase reflects DIRTT's ongoing investment in long-term growth initiatives. The most significant change can be attributed directly to sales-related efforts as salaries and commissions increased by $1.2 million. These costs reflect the addition of personnel focused on generating and supporting higher business volumes. Other increases in SG&A in Q3 2016 included depreciation and amortization expense of non-manufacturing-related assets of $0.7 million, travel and marketing costs of $0.6 million, professional fees of $0.2 million, rent expense of $0.2 million, stock-based compensation expense of $0.1 million, and $0.5 million in other operating expense items. The increase in depreciation and amortization expense of non-manufacturing-related assets correlates with the increase in our investment in leasehold improvements and software and product development. Adjusted SG&A % decreased slightly by 20 basis points from 29.3% to 29.1% in Q3 2016 compared with Q3 2015. Adjusted SG&A expenses increased by $2.7 million, or 14.7%, for Q3 2016 compared with Q3 2015. The reason for the increase is the same as discussed above with respect to SG&A, excluding the impact from increased non-cash depreciation and amortization of non-manufacturing-related assets and stock-based compensation expense incurred in the period. SG&A % increased by 270 basis points from 37.4% to 40.1% in YTD 2016 compared with the same period in 2015. SG&A expenses increased by $11.6 million, or 18.0%, for YTD 2016 compared with the same period in 2015. The increase reflects DIRTT's ongoing investment in long-term growth. The most significant changes can be attributed directly to marketing-related efforts as travel, marketing and trade show costs increased by $3.4 million, of which $1.2 million was related to DIRTT Connext™, DIRTT's largest and most important sales, marketing and training initiative which occurs every June in Chicago. The other significant change can be attributed directly to sales-related efforts as salaries and commissions increased by $1.6 million. These costs reflect adding personnel focused on generating and supporting higher business volumes. We expect the additional sales and marketing resources to support growth in 2017 and beyond. Other increases in SG&A in YTD 2016 included depreciation and amortization expense of non-manufacturing-related assets of $2.1 million, stock-based compensation expense of $1.2 million, software licenses and computer supplies of $0.8 million, rent expense of $0.7 million, professional service fees of $0.5 million, and $1.3 million in other operating expense items. Adjusted SG&A % increased by 140 basis points from 32.3% to 33.7% in YTD 2016 compared with the same period in 2015. Adjusted SG&A expenses increased by $8.3 million, or 14.9%, for YTD 2016 compared with the same period in 2015. The reason for the increase is the same as discussed above with respect to SG&A, excluding the impact from increased non-cash depreciation and amortization of non-manufacturing-related assets and stock-based compensation expense in the year. The higher US dollar to Canadian dollar average exchange rate (YTD 2016 - 1.3213; YTD 2015 - 1.2598) also contributed to the overall increase in SG&A and adjusted SG&A expenses across the organization for YTD 2016, as certain of these expenditures are denominated in US dollars. Adjusted EBITDA decreased slightly by $0.1 million for Q3 2016 compared with Q3 2015. Adjusted EBITDA % for Q3 2016 declined by 250 basis points from 18.0% in Q3 2015 to 15.5%. Adjusted EBITDA decreased by $2.2 million, or 9.8%, for YTD 2016 compared with the same period in 2015. Adjusted EBITDA % for YTD 2016 weakened by 230 basis points from 12.9% in YTD 2015 to 10.6%. The decrease in YTD 2016 was mainly due to the increase in foreign exchange loss of $3.5 million and higher adjusted SG&A expenses of $8.3 million, partially offset by higher adjusted gross profit of $9.5 million. Gains or losses in foreign exchange ("FX") are primarily the result of the period end revaluation of monetary assets and liabilities held within our Canadian companies. The largest component of these assets and liabilities is our holdings of US dollar cash and cash equivalents. The increase in foreign exchange loss of $3.5 million is the result of significant fluctuations in the CAD-US exchange rate in the year-over-year periods. During YTD 2015, the US dollar increased by $0.17 compared to year-end 2014, resulting in a $2.5 million gain on the revaluation of these monetary assets and liabilities. Conversely, during YTD 2016, the US dollar depreciated by $0.07 compared to year-end 2015, resulting in a $1.0 million loss being recognized. These amounts exclude any gains or losses resulting from the revaluation of our US dollar-denominated long-term debt, as these amounts have been added back in the determination of Adjusted EBITDA as per reconciliation below. Our growth strategy consists of five key initiatives: (1) increasing penetration of existing markets by providing continued support and increased investment to our existing DPs throughout North America; (2) expanding into new geographies, such as the Middle East and United Kingdom, by capitalizing on recent and continued investment alongside new international DPs; (3) penetrating new vertical markets such as the healthcare, education and residential sectors; (4) continuing to invest in ICE® and new innovative interior construction solutions such as the Enzo Approach, residential interiors and timber frame construction; and (5) partnering with industry leaders to monetize innovative solutions. Our previously announced programs to support our top-tier and next tier Distribution Partners, such as the DIRTT Movers Program, DIRTT Green Learning Center loan program, increasing investment in product development and ICE development are contributing to the momentum we are seeing as we start the fourth quarter of the year. Our unveiling of ICEreality™, bringing augmented reality to the construction industry, will change, we believe, the way people design, create, collaborate and build interiors. We believe the increasing investment our Distribution Partners are making in our business, with the addition of staff, increased investment in Green Learning Centers and their increased investment in DIRTT Connext, where their attendance was up 55%, is a strong indication of the long-term prospects for our business. We believe DIRTT Solutions and the resulting more efficient and cost-effective construction experience are a superior alternative to conventional construction across all sectors of the construction industry, and that a continued increase in global construction activity can be expected to result in an ongoing improvement to our revenue. We plan to invest additional resources, including continuing to develop and expand ICE and new DIRTT Solutions and test projects, to pursue further opportunities in the healthcare, education, government, corporate and residential sectors of the construction industry. At September 30, 2016, we had $88.1 million in cash and cash equivalents compared with $91.4 million at December 31, 2015. At September 30, 2016, we also had access to an undrawn US$18.0 million revolving credit facility. In March 2016, we signed a fourth amendment to the amended and restated loan agreement with our lenders which, among other things, provided us with an additional capital financing facility of US$10.0 million, of which $7.8 million (US$6.0 million) was drawn as at September 30, 2016. We expect to draw on the remainder of this facility by December 31, 2016. Adjusted gross profit, Adjusted gross profit %, Adjusted SG&A, Adjusted SG&A %, Adjusted EBITDA, Adjusted EBITDA % and cash provided by operating activities before changes in non-cash working capital are non-IFRS measures. Non-IFRS measures do not have a standard meaning as prescribed by IFRS, and are therefore unlikely to be comparable to similar measures presented and calculated by other companies. DIRTT believes the non-IFRS measures are useful supplemental measures that may assist investors in assessing DIRTT's business. The non-IFRS measures should not be considered as the sole measure of the Company's performance and should not be considered in isolation from, or as a substitute for, analysis of its financial statements. For a reconciliation of these non-IFRS measures as well as the rationale for management's use of such measures, see the Company's management's discussion and analysis for the three and nine-month periods ended September 30, 2016, available at http://www.sedar.com. DIRTT will host a conference call and webcast on Thursday, November 10, 2016 at 9 a.m. ET, 7 a.m. MT to discuss its third quarter results in greater detail. President Scott Jenkins and CFO Derek Payne will host the call. To access the conference call by telephone dial +1 844.413.7152 (toll-free in North America). Please call 10 minutes prior to the start of the call. In addition, a live webcast (listen only mode) of the conference call will be available at: http://edge.media-server.com/m/p/uie5r3uq Investors are invited to submit questions by email before and during the conference call. Please send them to email@example.com. A replay of the conference call will be available at 1.855.859.2056 by entering the passcode 2058996, from noon (ET) Thursday, November 10, 2016 to midnight (ET) Thursday, November 17, 2016 or through the webcast archives at http://edge.media-server.com/m/p/uie5r3uq or on DIRTT's website at www.dirtt.net/company/investor. DIRTT Environmental Solutions (Doing it Right This Time) uses its proprietary 3D software to design, manufacture and install fully customized prefabricated interiors. The Company's customers in the corporate, government, education and healthcare sectors benefit from DIRTT's precise design and costing; rapid lead times with the highest levels of customization and flexibility; and faster, cleaner construction. DIRTT's manufacturing facilities are in Phoenix, Savannah, Kelowna and Calgary. DIRTT's team supports nearly 100 Distribution Partners throughout North America, the Middle East and Asia. DIRTT trades on the Toronto Stock Exchange under the symbol "DRT." For more information visit www.dirtt.net. Certain information and statements contained in this news release constitute "forward-looking information" and "forward-looking statements" (collectively, "Forward-Looking Information") as defined under applicable Canadian securities laws and the Company hereby cautions investors about important factors that could cause the Company's actual results or outcomes to differ materially from those projected in any Forward-Looking Information contained in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as "will likely result", "are expected to", "will continue", "is anticipated", "believes", "estimated", "intends", "plans", "projection" and "outlook"), are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such Forward-Looking Information. In particular and without limitation, this news release contains Forward-Looking Information pertaining to the following: comments with respect to the Company's revenue, objectives and priorities for 2016 and beyond; comments with respect to shipping trends, order entry momentum and revenue growth expectations for the fourth quarter of 2016; project timetables; the benefits of the DIRTT Movers Program; the anticipated use of its credit facilities, comments with respect to the new GLC in London, United Kingdom; its growth strategies and opportunities; its ability to meet working capital requirements and financial obligations; use and deployment of the Company's capital; and its outlook for its operations and the Canadian, US and international economies, and in particular, the US and Canadian construction industry. 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New factors emerge from time to time, and it is not possible for DIRTT's management to predict all of these factors and to assess in advance the impact of each such factor on the Company's business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in Forward-Looking Information. No assurance can be given that these expectations will prove to be correct and such Forward-Looking Information contained in this news release should not be unduly relied upon. In addition, this news release may contain Forward-Looking Information attributed to third party industry sources. For a detailed description of the risks and uncertainties facing the Company and its business and affairs, readers should refer to the Company's annual financial statements, management's discussion and analysis and annual information form for the year ended December 31, 2015, all of which are available at http://www.sedar.com. 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News Article | December 19, 2016
Graying hair, crow's feet, an injury that's taking longer to heal than when we were 20 - faced with the unmistakable signs of aging, most of us have had a least one fantasy of turning back time. Now, scientists at the Salk Institute have found that intermittent expression of genes normally associated with an embryonic state can reverse the hallmarks of old age. This approach, which not only prompted human skin cells in a dish to look and behave young again, also resulted in the rejuvenation of mice with a premature aging disease, countering signs of aging and increasing the animals' lifespan by 30 percent. The early-stage work provides insight both into the cellular drivers of aging and possible therapeutic approaches for improving human health and longevity. "Our study shows that aging may not have to proceed in one single direction," says Juan Carlos Izpisua Belmonte, a professor in Salk's Gene Expression Laboratory and senior author of the paper appearing in the Cell. "It has plasticity and, with careful modulation, aging might be reversed." As people in modern societies live longer, their risk of developing age-related diseases goes up. In fact, data shows that the biggest risk factor for heart disease, cancer and neurodegenerative disorders is simply age. One clue to halting or reversing aging lies in the study of cellular reprogramming, a process in which the expression of four genes known as the Yamanaka factors allows scientists to convert any cell into induced pluripotent stem cells (iPSCs). Like embryonic stem calls, iPSCs are capable of dividing indefinitely and becoming any cell type present in our body. "What we and other stem-cell labs have observed is that when you induce cellular reprogramming, cells look younger," says Alejandro Ocampo, a research associate and first author of the paper. "The next question was whether we could induce this rejuvenation process in a live animal." While cellular rejuvenation certainly sounds desirable, a process that works for laboratory cells is not necessarily a good idea for an entire organism. For one thing, although rapid cell division is critical in growing embryos, in adults such growth is one of the hallmarks of cancer. For another, having large numbers of cells revert back to embryonic status in an adult could result in organ failure, ultimately leading to death. For these reasons, the Salk team wondered whether they could avoid cancer and improve aging characteristics by inducing the Yamanaka factors for a short period of time. To find out, the team turned to a rare genetic disease called progeria. Both mice and humans with progeria show many signs of aging including DNA damage, organ dysfunction and dramatically shortened lifespan. Moreover, the chemical marks on DNA responsible for the regulation of genes and protection of our genome, known as epigenetic marks, are prematurely dysregulated in progeria mice and humans. Importantly, epigenetic marks are modified during cellular reprogramming. Using skin cells from mice with progeria, the team induced the Yamanaka factors for a short duration. When they examined the cells using standard laboratory methods, the cells showed reversal of multiple aging hallmarks without losing their skin-cell identity. "In other studies scientists have completely reprogrammed cells all the way back to a stem-cell-like state," says co-first author Pradeep Reddy, also a Salk research associate. "But we show, for the first time, that by expressing these factors for a short duration you can maintain the cell's identity while reversing age-associated hallmarks." Encouraged by this result, the team used the same short reprogramming method during cyclic periods in live mice with progeria. The results were striking: Compared to untreated mice, the reprogrammed mice looked younger; their cardiovascular and other organ function improved and - most surprising of all - they lived 30 percent longer, yet did not develop cancer. On a cellular level, the animals showed the recovery of molecular aging hallmarks that are affected not only in progeria, but also in normal aging. "This work shows that epigenetic changes are at least partially driving aging," says co-first author Paloma Martinez-Redondo, another Salk research associate. "It gives us exciting insights into which pathways could be targeted to delay cellular aging." Lastly, the Salk scientists turned their efforts to normal, aged mice. In these animals, the cyclic induction of the Yamanaka factors led to improvement in the regeneration capacity of pancreas and muscle. In this case, injured pancreas and muscle healed faster in aged mice that were reprogrammed, indicating a clear improvement in the quality of life by cellular reprogramming. "Obviously, mice are not humans and we know it will be much more complex to rejuvenate a person," says Izpisua Belmonte. "But this study shows that aging is a very dynamic and plastic process, and therefore will be more amenable to therapeutic interventions than what we previously thought." The Salk researchers believe that induction of epigenetic changes via chemicals or small molecules may be the most promising approach to achieve rejuvenation in humans. However, they caution that, due to the complexity of aging, these therapies may take up to 10 years to reach clinical trials. Other authors included: Aida Platero-Luengo, Fumiyuki Hatanaka, Tomoaki Hishida, Mo Li, David Lam, Masakazu Kurita, Ergin Beyret, Toshikazu Araoka, Eric Vazquez-Ferrer, David Donoso, Jose Luis Roman, Jinna Xu and Concepcion Rodriguez of the Salk Institute; Estrella Nuñez Delicado of Universidad Católica San Antonio de Murcia; Gabriel Núñez of the University of Michigan Medical School; Josep Maria Campistol of Hosplital Clinic of Barcelona and Isabel Guillén and Pedro Guillén of Fundación Dr. Pedro Guillén. The work and the researchers involved were supported in part by a National Institutes of Health Ruth L. Kirschstein National Research Service Award Individual Postdoctoral Fellowship, the Muscular Dystrophy Association, Fundación Alfonso Martin Escudero, the Hewitt Foundation, the Uehara Memorial Foundation, the Nomis Foundation, a JSPS Postdoctoral Fellowship for Research Abroad, the University of California, San Diego, the G. Harold and Leila Y. Mathers Charitable Foundation, The Leona M. and Harry B. Helmsley Charitable Trust (2012-PG-MED002), The Glenn Foundation, Universidad Católica San Antonio de Murcia (UCAM) and Fundación Dr. Pedro Guillén. Article: In Vivo Amelioration of Age-Associated Hallmarks by Partial Reprogramming, Juan Carlos Izpisua Belmonte, Cell, doi: 10.1016/j.cell.2016.11.052, published 15 December 2016.
News Article | February 16, 2017
Paris, February 16th, 2017, 5:45 pm: HiPay Group (ISIN code FR0012821916 - HIPAY), a Fintech company specialized in online payments, looks back at a year of sustained growth. With €30.7 million in revenue - a 19 % growth in 2016, combined with a positive business outlook, the Group reinforces its market position and continues to pursue its expansion based on its solutions in omni-channel payment, data and analytics and global payment coverage. Revenue increased by 16% over the fourth quarter, reaching €8.2 million. The runrate, transactions processed with HiPay during the last month of the year, extrapolated over twelve months, reached 2.4 billion euros. The fourth quarter confirmed the high level of growth observed throughout the year. Transactions processed climbed to €507 million over the last three months, representing more than twice the number of transactions processed during the same period in 2015 (+103%). In 2016, the payment activity's sales totaled €19.2 million, a 46% growth compared to 2015. Transactions processed increased by 90% over the year, reaching €1.5 billion, with a monthly record in December of €190 million. This dynamic growth demonstrates the significance of the HiPay platform. The payment division now represents 90% of the transactions processed by the Group. HiPay Enterprise, our solution for large e-tailers, added more than a hundred new clients during the year, in France and internationally, including Claudie Pierlot, ePRICE, ID Kids, Intermarché, Maje, Natalys, Netatmo, Sandro, Verbaudet, and Videdressing. Regarding HiPay Professional, the payment solution dedicated to smaller e-tailers, the number of active clients reached 2,500 merchants. The micropayment division sales decreased by 9% during the exercise, of which -28% in the last quarter. This decline is related to, in part, the decision by carriers to discontinue a historical payment method, and also to the termination of non-strategic activities by refocusing on more promising verticals. In line with this strategy, HiPay Mobile will continue to strengthen its teams to sustain its position in the gaming market and to increase its business performance with new products, such as donations via SMS. Beginning with the 2013 AFM Telethon (French Muscular Dystrophy Association), the new offering is now launched with other associations, including SOS Villages d'Enfants and Fondation Hôpitaux de Paris - Hôpitaux de France. We're a global payment provider processing more than 2bn € annually across 150 countries and 220 payment types. By harnessing data analytics we help deliver valuable customer insights that enable our client's businesses to succeed. More information on hipay.com Find us on Twitter, LinkedIn and Google+ HiPay Group is listed on the Euronext Paris Compartment C (ISIN code: FR0012821916/Mnemo: HIPAY). This press release does not constitute an offer to sell or a solicitation of an offer to buy HiPay Group shares. If you wish to obtain more information about HiPay Group, please refer to our website hipay.com, under the Investors heading. This press release may contain some forward-looking statements. Although HiPay Group considers that these statements are based on reasonable statements on the publication date of this release, they are by their very nature subject to risks and uncertainties that could cause the actual results to differ from those indicated or projected in these statements. HiPay Group operates in a continually changing environment and new risks could potentially emerge. HiPay Group assumes no obligation to update these forward-looking statements, whether to reflect new information, future events or other circumstances.
News Article | February 15, 2017
A puzzling question has lurked behind SMA (spinal muscular atrophy), the leading genetic cause of death in infants. The disorder leads to reduced levels of the SMN protein, which is thought to be involved in processing RNA, something that occurs in every cell in the body. So why does interfering with a process that happens everywhere affect motor neurons first? Scientists at Emory University School of Medicine have been building a case for an answer. It's because motor neurons have long axons. And RNA must be transported to the end of the axons for motor neurons to survive and keep us moving, eating and breathing. Now the Emory researchers have a detailed picture for what they think the SMN protein is doing, and how its deficiency causes problems in SMA patients' cells. The findings are published in Cell Reports. "Our model explains the specificity -- why motor neurons are so vulnerable to reductions in SMN," says Wilfried Rossoll, PhD, assistant professor of cell biology at Emory University School of Medicine. "What's new is that we have a mechanism." Rossoll and his colleagues showed that the SMN protein is acting like a "matchmaker" for messenger RNA that needs partners to transport it into the cell axon. RNA carries messages from DNA, huddled in the nucleus, to the rest of the cell so that proteins can be produced locally. But RNA can't do that on its own, Rossoll says. In the paper, the scientists call SMN a "molecular chaperone." That means SMN helps RNA hook up with processing and transport proteins, but doesn't stay attached once the connections are made. "It loads the truck, but it's not on the truck," Rossoll says. Using fluorescence inside living cells as well as biochemistry, they showed that SMN promotes an interaction between the 'zipcode' region of a test RNA and a transport protein. Some of the experiments included cells from SMA patients, obtained through a collaboration with Han Phan, MD, a pediatric neurologist at Children's Healthcare of Atlanta, and the Laboratory for Translational Cell Biology at Emory. The first author of the paper is Paul Donlin-Asp, PhD, a former Biochemistry, Cell and Developmental Biology graduate student, now at the Max Planck Institute in Frankfurt,. Co-senior author is Gary Bassell, PhD, chair of the Department of Cell biology at Emory University School of Medicine. Scientists have known for 20 years that SMN is necessary in every cell of the body, since disrupting the gene in a mouse causes early embryonic death, before muscle or nerve cells form. However, humans have two SMN genes, one more than mice, so a mutation in the first gene usually leads to reduced levels of SMN protein but not its elimination. An antisense-based treatment called nusinersen, which removes a roadblock in the expression of the second SMN gene, was recently approved by the FDA. Rossoll says his team's research helps to clarify SMN's role in motor neurons and other cells, and insights into its function could be important for optimizing delivery of the newly available treatment or development of additional treatments. The research was supported by the Muscular Dystrophy Association, the Weissman Family Foundation, the National Institute of Neurological Disorders and Stroke (R01NS091749, F31NS084730, P30NS055077) and the ARCS Fellowship Roche Foundation.
News Article | November 17, 2016
Casey’s General Store locations and customers in its 14-state area rallied together to raise a record $1,527,208 million during the Muscular Dystrophy Association's Summer Camp pinup program to help kids fighting muscular dystrophy and related life-threatening diseases experience a week of fun and friendship at MDA Summer Camp — all at no cost to their families. “For 10 years, Casey’s employees and customers have continued to go above and beyond to raise vital funds for individuals living with muscle-debilitating diseases in our communities,” said Casey’s General Store President and CEO Terry Handley. “We’re honored to put our collective strength behind helping such a worthy cause that will send some amazing kids to MDA Summer Camp where they will have a chance to discover new interests and independence in an environment where barriers don’t exist." From Aug. 1 to Sept. 5, Casey’s General Store and its associates sold pinups for $1 and $5 contributions to MDA, with the goal of helping send more than 1,900 local kids to MDA Summer Camp through their local office locations. This year’s pinups also included a “buy two, get one free” coupon for 7UP products. Funds raised during the summer camp pinup program help support MDA’s efforts to make each camp fully-accessible and medically-safe for its campers. They also help provide meals and snacks for each child, 24-hour medical staff on site, lodging for the full week and offer customized activities, such as swimming, horseback riding, zip-lining, adaptive sports and more, so every child can fully participate and truly live unlimited. “We are extremely grateful for the generosity of Casey’s General Store employees and customers who opened their hearts to help individuals with muscle-debilitating diseases live longer and grow stronger,” said MDA National Director of Retail Partnerships Sabrina Hughes. “Because of this year’s record-breaking pinup donations, we will be able to help give over nineteen hundred local kids the invaluable, life-changing experience of attending MDA Summer Camp where they will have the chance to gain important life skills to help them face daily challenges that having a muscle-debilitating disease can often bring.” Casey’s General Store has raised more than $8 million since 2006 in support of MDA’s shared mission to find treatments and cures for people whose abilities to move have been compromised by neuromuscular disease - including everyday abilities like walking, running, hugging, talking and even breathing. In addition to summer camp pinup sales, Casey’s contributions from year-round local events help support MDA families, including the Casey’s General Store Muscle Team Dinner & Auction on Nov. 2, 2016. Casey’s employees regularly participate in MDA Lock-Up events and also are involved in providing activities and volunteering at MDA Summer Camps across the Midwest. About MDA MDA is leading the fight to free individuals — and the families who love them — from the harm of muscular dystrophy, ALS and related muscle-debilitating diseases that take away physical strength, independence and life. We use our collective strength to help kids and adults live longer and grow stronger by finding research breakthroughs across diseases; caring for individuals from day one; and empowering families with services and support in hometowns across America. Learn how you can fund cures, find care and champion the cause at mda.org.
News Article | March 1, 2017
CHICAGO, March 1, 2017 /PRNewswire-USNewswire/ -- Tens of thousands of retailers nationwide have rallied together to raise funds to help the Muscular Dystrophy Association (MDA) save and improve the lives of kids and adults with muscular dystrophy by participating in the 35th annual MDA...
News Article | February 16, 2017
The Maria Jackson Insurance Agency, a San Antonio firm that offers asset protection services and financial planning assistance to communities throughout southern Texas, is embarking on a charity drive to raise support and awareness for the Muscular Dystrophy Association’s Muscle Walk. The MDA Muscle Walk is a life changing community-oriented event that empowers families struggling with Muscular Dystrophy, and funds raised during the event go to researching cures and treatments for several muscle-debilitating diseases. The Maria Jackson Insurance Agency hosted a Rally Day on February 1st with the goal of raising $500 for MDA in a single afternoon. “It was truly a blessing. MDA's Fundraising Director, Margaret Adams, was kind enough to visit our office with the father of a child who received support from the MDA. He touched our hearts with his story, and we are so glad to have the opportunity to work with such a great organization,” said Maria Jackson, owner and executive director of the Maria Jackson Insurance Agency. Jackson and her team are pursuing additional efforts to raise awareness and community support for the MDA Muscle Walk. Efforts to bring in support over social media and email channels are already underway, and the agency is planning a full length feature article on the charity event which will soon be released in the Maria Jackson Insurance online magazine “Our Hometown”: http://www.mariajacksonagency.com/Our-Hometown-Magazine_39. A dozen charitable causes and nonprofit organizations operating in and around San Antonio have enjoyed the support of the Maria Jackson Insurance Agency over the last two years. As members of the “Agents of Change” charity support network, Jackson and her team are committed to working with new charities in the region on a bimonthly basis. All those who want to know more about the charity event to support the MDA Muscle Walk in San Antonio are encouraged by the Jackson team to visit the following page and take action to further the cause: http://www.mariajacksonagency.com/Walking-For-Muscles-With-MDA_24_community_cause. Details regarding previous charity drives hosted by the Maria Jackson Insurance Agency can be found on the firm’s Community Causes listing: http://www.mariajacksonagency.com/community-cause?page=1. Serving from offices in San Antonio, TX, Maria Jackson Insurance Agency is committed to bringing local communities an insurance agency that understands their needs. Taking pride in its team of professionals, Maria Jackson Insurance Agency works with carriers to assemble a variety of products and services for its customers. From all of the products a typical consumer needs (home, auto, boat, ATV, etc.,) to all financial services products and tools (retirement, savings, long term care, disability, etc.,) and business insurance (liability, building, auto) to workplace and individual benefits (accident, critical illness, cancer, disability, life), Maria Jackson covers all the bases for insurance needs in the San Antonio, Texas area. To reach the Maria Jackson Insurance Agency, visit http://www.mariajacksonagency.com/ or call (210) 494-2471.