ATNX = RBC Capital analyst Kennen MacKay noted that the San Antonio Breast Cancer Symposia, or SABCS, announced that Athenex’s oraxol abstract was selected for the event’s official press program and will remain under embargo until the morning of its presentation on December 13. He stated that SABCS “traditionally selects what they see as the most practice changing and sensational abstracts” for media embargo, calling this the “third SABCS win” for the company following a title change to reflect oraxol achieving a survival advantage and the inclusion of “major breast cancer KOL thought leader” Dr. Hope Rugo. MacKay keeps an Outperform rating on Athenex shares.
NTLA = Back on November 1, 2019, Raymond James analyst Steven Seedhouse upgraded Intellia Therapeutics to Outperform from Market Perform with a $24 price target. In a research note to investors, Seedhouse says Intellia’s NTLA-2001 is poised to benefit from the “heavy lifting” Pfizer (PFE) is doing commercially with Vyndaqel in ATTR-cardiomyopathy, adding that Intellia is also advancing manufacturing related activities in support of a Phase 1 trial for engineered cell program WT1-TCR in AML. The analyst also says Intellia’s lead gene editing program, NTLA-2001 has “really good” primate data showing TTR knockdown potentially better than Alnylam’s (ALNY) patisiran. He expects the market will already start to impute downstream clinical benefit for NTLA-2001 after only a few patients with initial TTR knockdown data, because of the collective data for Ionis Pharmaceuticals’ (IONS) inotersen and Alnylam’s patisiran showing knockdown is relevant.
JKS = Reports Q3 revenue $1.05B, consensus $1.01B. Kangping Chen, JinkoSolar’s CEO commented, “I’m pleased to report strong operational and financial results for Q3 which I believe marks a turning point for our business, as we begin to increasingly benefit from our technology transformation, industry-leading cost structure and expanding mono capacity. Module shipments during the quarter were 3,326 megawatts, an increase of 12.6% year-over-year and a slight decrease sequentially. Our integrated production costs continued to decrease, which, combined with our high-quality products and global distribution footprint, allowed us to initiate a reset of our gross margin, expanding it to 21.3% during the quarter, a significant 6 percentage point increase year-over-year. We are very optimistic about our growth prospects next quarter and throughout 2020 where we expect to see our overall profitability strengthen and margins expand. Our technological transformation began in 2016 when we started producing mono wafers, and have since then accumulated three years of operational and technical expertise which we applied in our mono production facility in Leshan, Sichuan Province. This technological transformation is now largely complete, with Phase I of the production facility having begun operations and ramped up to full 5GW capacity during the second quarter of 2019. I believe this reflects our strategic foresight and strong execution capabilities. We are now at a strategic turning point in our corporate history with mono-based high-efficiency products accounting for nearly 75% of the total solar module shipments during the quarter, which is expected to increase to 99% in 2020. The late announcement of the government subsidy policy for PV projects in China earlier this year delayed a large number of projects which we believe will restart during the fourth quarter and the first quarter of 2020. This delay is expected to drive strong domestic demand over the next six months, especially since China’s national renewable energy information management center recently announced that it is accelerating the formulation of subsidy policies for PV projects in 2020. With the cost of solar energy now falling below that of conventional energy sources in many markets across the globe and more aggressive clean energy targets being set by governments, we are also very confident and optimistic that global demand will significantly increase next year. We currently estimate that global installations next year will be approximately 20% higher than this year. We continue to invest in product development to meet growing market demand for high-quality and efficient products. We expanded our production capacity of N-type cells to 800MW during the quarter, and are currently ramping up to full production which is expected to begin next quarter. Our N-type cells reached a record high efficiency of 24.58% in June 2019. We also recently unveiled a new Tiger module which, with its 20.78% efficiency and peak power output of 460W, offers our clients significantly improved efficiency, lower production costs and a better internal rate of return. With domestic demand rebounding strongly and overseas demand driven by aggressive new clean energy targets, we expect the fourth quarter and full year 2020 to generate strong growth in shipments and strengthen our overall profitability and margin profile. With the demand growing rapidly both domestically and overseas for our mono products, we have strategically decided to convey our confidence in next year’s strong growth with total solar module shipments expected to be in the range of 18.0 GW to 20.0 GW for the full year 2020, an approximately 35% year-over-year increase. As one of the largest and most innovative solar module manufacturers in the world, we will continue to drive growth in this new era of grid parity and deliver long-term sustainable value to our shareholders.”
SAEX = SAExploration Holdings announced a combined $130M of new projects in Alaska, Canada and the Middle East. The largest contract is valued at approximately $112Mn for onshore data acquisition services to be performed on the North Slope of Alaska. The data acquisition services will be conducted over the next three winter seasons, beginning in Q1 2020. In association with this multi-year project award, SAE has entered into a separate agreement with Geospace Technologies Corporation to purchase 30,000 new state-of-the-art GCL recording channels. The new Geospace channels will primarily be utilized during the aforementioned multi-year contract in Alaska, but are also intended to be utilized in other regions, when available, during the off season. The balance of the new project awards consists of various contracts in Canada, slated to be performed primarily during the upcoming Q1 2020 winter season, and a new research and development pilot contract in the Middle East with two major integrated oil companies, where thousands of next-generation wireless sensors, dropped by a smart, automated fleet of drones, will take high-density, 3D images of the subsurface. Michael Faust, Chairman and CEO of SAE, commented “We are very pleased to announce these new projects and are grateful that our customers have displayed such confidence in our ability to continue to deliver high quality products and services safely and efficiently. Our backlog for the remainder of 2019 is approximately $67 million and our contracted backlog for 2020 is already at approximately $96 million. SAE is committed to deploying cutting edge technology to further minimize our footprint and reduce environmental exposure everywhere we operate. The purchase of 30,000 small light-weight GCL recording channels, and the automated drone deployment pilots, are strong examples of that commitment to continuously raising the bar on health, safety and environmental protection.”
On November 18, 2019, Geospace Technologies (GEOS) announced the receipt of an order for its GCL wireless recording system from SAExploration, a wholly-owned subsidiary of SAExploration Holdings,(SAEX). The order is for 30,000 single-channel recording stations and related equipment. Revenue on the order will be approximately $12.5 million and the company expects delivery of the system to occur in its second quarter ending March 31, 2020. Walter Wheeler, President and CEO of Geospace Technologies, said, “Our GCL represents the most advanced technology available in cable-free seismic recording systems, and we are very appreciative of the conscious choice made by SAExploration to incorporate this unique technology in their operations.”
ESPR = Esperion (NASDAQ: ESPR) today announced that pooled analyses from four Phase 3 clinical studies of bempedoic acid were presented at the American Heart Association (AHA) Scientific Sessions in Philadelphia. Bempedoic acid is being developed as a convenient, once-daily, oral therapy for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C) added onto maximally tolerated statin therapy. Bempedoic acid and the bempedoic acid 180 mg + ezetimibe 10 mg fixed dose combination (FDC) tablets’ new drug applications (NDAs) are currently under regulatory review by the U.S. Food and Drug Administration (FDA) and the marketing authorisation applications (MAAs) are currently under centralized review by the European Medicines Agency (EMA).
The presentation, titled “Bempedoic Acid and Glycemic Control: A Pooled Analysis of 4 Phase 3 Clinical Trials” was delivered by Lawrence A. Leiter, MD, FRCPC, FACP, FACE, FAHA Director of the Lipid Clinic at St. Michael’s Hospital and Professor of Medicine and Nutritional Sciences, University of Toronto. The presentation highlighted that bempedoic acid reduced hemoglobin A1c (HbA1c) by 0.19% versus placebo in patients with diabetes (n=1,134) at 12 weeks. The analysis also showed that patients on bempedoic acid had fewer instances of new-onset diabetes as well as hyperglycemia than those on placebo.
In addition, a poster, titled “Efficacy of Bempedoic Acid: A Pooled Analysis of 4 Pivotal Phase 3 Clinical Trials” was presented by Maciej Banach, MD, PhD, FAHA, FESC. The poster highlighted that in the pooled Phase 3 studies, bempedoic acid significantly lowered LDL-C in patients with hypercholesterolemia when added-on to maximally tolerated statin therapy, which may mean no statin at all. In patients on background statin therapy, bempedoic acid lowered LDL-Cholesterol by 18% compared to placebo. In patients not on statin background therapy and considered statin intolerant, bempedoic acid lowered LDL-Cholesterol by 25% compared to placebo.
“We are very pleased with the pooled analyses from the Phase 3 LDL-C lowering clinical development program showing bempedoic acid not only lowered LDL-C by 25% but also reduced HbA1c by 0.19% in 1,134 patients with diabetes,” said Tim Mayleben, president and chief executive officer of Esperion. “These pooled analyses further support our confidence that bempedoic acid could be a convenient and important, oral, once-daily drug for the millions of patients on maximally tolerated statin therapy who need additional LDL-C lowering.”
Bempedoic acid is our lead, non-statin, oral, once-daily, LDL-C lowering therapeutic candidate, currently under regulatory review by the FDA and EMA. With a targeted mechanism of action, bempedoic acid is a first-in-class, ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptor. Bempedoic acid has been observed to reduce hsCRP, a key marker of inflammation associated with cardiovascular disease. Completed Phase 3 studies conducted in more than 4,000 patients, with over 2,600 patients treated with bempedoic acid, demonstrated up to 18 percent placebo corrected LDL-C lowering when used with moderate- and high-intensity statins and 21 to 28 percent placebo corrected LDL-C lowering when used with low dose or no background statin.
Bempedoic Acid / Ezetimibe Fixed Dose Combination Tablet
Through the complementary mechanisms of action of inhibition of cholesterol synthesis (bempedoic acid) and inhibition of cholesterol absorption (ezetimibe), the bempedoic acid / ezetimibe fixed dose combination tablet is a non-statin, orally available, once-daily, LDL-C lowering therapeutic candidate, currently under review by the FDA and EMA. Inhibition of ATP Citrate Lyase (ACL) by bempedoic acid lowers LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptor. Inhibition of Niemann-Pick C1-Like 1 (NPC1L1) by ezetimibe results in reduced absorption of cholesterol from the gastrointestinal tract, thereby reducing delivery of cholesterol to the liver. Phase 3 data demonstrated that this combination resulted in a 29 percent placebo corrected LDL-C lowering when used with maximally tolerated statins, a 44 percent LDL-C lowering when used with no background statin (post-hoc analysis), and a 34 percent reduction in high sensitivity C-reactive protein (hsCRP).
CLEAR Cardiovascular Outcomes Trial
The effect of bempedoic acid on cardiovascular morbidity and mortality has not yet been determined. Esperion initiated a global cardiovascular outcomes trial (CVOT) to assess the effects of bempedoic acid on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease (CVD) who are only able to tolerate less than the lowest approved daily starting dose of a statin and considered “statin averse.” The CVOT — known as CLEAR Cardiovascular Outcomes Trial — is an event-driven, global, randomized, double-blind, placebo-controlled study that completed enrollment in August 2019 of 14,032 patients with hypercholesterolemia and high CVD risk at over 1,400 sites in 32 countries.
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