NVAX = B. Riley FBR resumed coverage of Novavax with a Buy rating and $12 price target.
TNXP = Tonix Pharmaceuticals Holding announced that it received the official minutes from the Breakthrough Therapy Type B Clinical Guidance meeting with the U.S. Food and Drug Administration for Tonmya or TNX-102 SL, cyclobenzaprine sublingual tablets, for the treatment of posttraumatic stress disorder, PTSD. The minutes are consistent with the the guidance received at the meeting. As previously announced, the primary endpoint of the RECOVERY Phase 3 trial will be at Week 12, and the Company plans to add an unblinded interim analysis that allows for a potential sample size adjustment. The ongoing RECOVERY trial is enrolling patients with PTSD from civilian or military traumas that occurred within nine years of screening. Seth Lederman, M.D., President and Chief Executive Officer of Tonix commented, “The minutes from our Breakthrough Therapy Clinical Guidance meeting are consistent with the agreement that we previously announced. With more than 50 percent of the current target number of participants enrolled, we look forward to reporting the results of the interim analysis in the first quarter of 2020, followed by topline data in the second quarter of 2020.” As previously communicated, the Phase 3 study design changes are being implemented after the FDA indicated the importance of showing persistence of treatment effect at Week 12 in a pivotal study. The primary endpoint will be mean change from baseline in the severity of PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5,CAPS-5, assessed at Week 12. Week 12 was the same timepoint analyzed for the CAPS-5 primary endpoint in the previous Phase 3 HONOR and Phase 2 AtEase studies of Tonmya for PTSD.
PTI = Still attracting buyer interest after November 7, quarterly report. Proteostasis Therapeutics, Inc. (NASDAQ:PTI), a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF) and other diseases caused by dysfunctional protein processing, on November 7, 2019, announced financial results for the third quarter ended September 30, 2019 and provided a corporate update.
“With equally strong demand from both US and ex-US clinical centers, we were able to complete enrollment in a little over four months for our 28-day global Phase 2 study of our doublet and triplet cystic fibrosis transmembrane conductance regulator (CFTR) combinations, and we now expect to report top line results later this quarter,” said Meenu Chhabra, President and Chief Executive Officer of Proteostasis Therapeutics. “CFTR modulator therapy is on the threshold of transforming CF from a life limiting disease into a chronic condition, increasing life span and quality of life. Yet standard of care CFTR modulator treatment still leaves behind many people with CF, as tolerability, efficacy, access and eligibility remain disparate across patient populations. PTI is committed to delivering additional CFTR modulator treatment options to address these significant unmet needs.”
Earlier this week, PTI announced the completion of enrollment in the Company’s 28-day, Phase 2 study evaluating its proprietary doublet (PTI-808 and PTI-801) and triplet (PTI-808, PTI-801 and PTI-428) CFTR modulator combinations, at doses selected based on the totality of dose range finding data from approximately 250 CF subjects studied thus far. The study design targeted up to 30 F508del homozygous and up to 30 F508del heterozygous subjects. Study endpoints include safety, changes in sweat chloride concentration and changes in percent predicted FEV1 (ppFEV1). Due to rapid enrollment from centers in the United States, Canada, Western Europe, and New Zealand, data from the study are now expected in the fourth quarter of 2019 instead of the first quarter of 2020.
Data from the Company’s CF clinical development programs were recently highlighted at the North American Cystic Fibrosis Conference in presentations delivered by Patrick Flume, M.D., Professor of Medicine and Pediatrics, Medical University of South Carolina and Jennifer L. Taylor-Cousar, M.D., M.S.C.S., Associate Professor of Medicine and Pediatrics, and Co-Director and CF Therapeutics Development Network Director of the Adult CF Program at National Jewish Health.
Last month, PTI hosted a cystic fibrosis patient summit on the disparity in access to CFTR modulator treatments. The event featured members of the CF community, including thought leaders, people with CF and CF advocates, and panel discussions focused on current unmet needs in CF.
In July, PTI announced the appointment of Geoffrey S. Gilmartin, M.D., M.M.Sc., as the Company’s Chief Medical Officer (CMO), and Andrey E. Belous, M.D., Ph.D., as a Senior Medical Director. Dr. Gilmartin served previously as the medical lead for the Kalydeco label expansion program at Vertex Pharmaceuticals Inc. Dr. Belous joined the Company from Galapagos NV, where he most recently served as a Medical Director for the Company’s Phase 3 program in Idiopathic Pulmonary Fibrosis (IPF).
BOX = Reported a revenue beat. Box reports Q3 adjusted EPS (1c), consensus (1c). Reports Q3 revenue $177.2M, consensus $174.63M. “With these solid results and our delivery of key product and go-to-market initiatives, we are in a strong position to continue to improve our balance between growth and profitability,” said Aaron Levie, co-founder and CEO of Box. “In Q3, we launched Box Shield, major new Relay enhancements, and deeper integrations with IBM, Microsoft Teams, and Slack. These new products and capabilities will enable our customers to expand their use of Box for frictionless security and compliance, seamless internal and external collaboration and workflows, and a more productive workplace by leveraging a best-of-breed IT stack. And with Box Suites, we are making it easier than ever for customers to adopt the full power of Box.”
AVX = Kyocera Corporation announced that it has made a proposal to a special committee of the board of directors of AVX Corporation to acquire all outstanding shares of common stock of AVX not owned by Kyocera for $19.50 per share in cash. The proposal represents a 29.7% premium over the closing price as of November 26, and 27.4%, 27.6% and 27.0% premium over a 1-, 3- and 6- month average closing share price, respectively. Kyocera currently owns approximately 72% of AVX’s outstanding shares of common stock. If the transaction is completed, AVX would become a wholly owned subsidiary of Kyocera. “The proposal will be reviewed by the special committee. No assurance can be given whether such proposal will lead to a transaction or as to any of the terms or conditions of such transaction. Kyocera does not intend to disclose any developments unless or until it otherwise deems further disclosure is appropriate or required,” the company stated.
CENTA = Central Garden & Pet reports Q4 adjusted EPS 4c, consensus 17c. Reports Q4 revenue $540.74M, consensus $521.94M. Tim Cofer, Central Garden & Pet’s new Chief Executive Officer said, “My early days at Central have strengthened my conviction that Central is well-positioned as a leader in the pet and garden industries. One of my observations is that we have opportunities to enhance our position by investing more in demand creation capabilities and initiatives to drive long-term sustainable profitable growth.”
PDS = Still attracting buyer interest after November 19, 2019, press release on the rollout of its Alpha brand.
Precision Drilling Corporation (TSX:PD; NYSE:PDS) is pleased to announce the commercialization of its automation services and the new brand roll-out of its Alpha™ technology offering, which includes the following core services:
AlphaAutomation™ – previously referred to as Process Automation Control (PAC)
Precision’s AlphaAutomation technology significantly enhances the efficiency and value of its Super Triple drilling rig fleet and currently includes 32 systems deployed across various basins in the U.S. and Canada. The benefits of enhanced drilling efficiency, well-cost savings and consistency gains AlphaAutomation provides when combined with Precision’s Super Triple rig package is a compelling performance and value proposition for our customers. AlphaAutomation systems are currently contracted at commercial rates, earning expected returns and achieving over 90% utilization, demonstrating that Precision has achieved commercial acceptance.
A key component of AlphaAutomation is its open platform, which is designed to host multiple drilling performance applications consisting of in-house, customer-developed or third-party applications. Precision has partnered with various industry leaders and currently has 15 revenue generating AlphaApps either commercialized or in development, adding to its growing portfolio of technology offerings.
Precision intends to continue deploying this offering across its standardized Super Triple fleet, driven by continued customer demand to lower drilling costs and improve capital efficiency. This includes 24 additional systems over the next 12 months, which have already been included in Precision’s previously guided 2020 capital expenditure budget range of $60 million to $80 million.
Precision’s CEO, Kevin Neveu stated: “I am excited to announce the full commercialization of Precision Drilling’s automation technology and to unveil the Alpha designation for Precision’s digital technologies. AlphaAutomation running on our Super Triple rigs has provided unequivocally safe, cost efficient, consistent and repeatable drilling performance on all types of oil and gas wells. Achieving this milestone is a result of three years of field-hardening the software, extensively training our crews and closely collaborating with our customers in order to overcome field acceptance hurdles and fully demonstrate the value our technology delivers. We have drilled over 1,000 wells with AlphaAutomation and have successfully deployed this highly scalable technology throughout North America. Without question, our Alpha technology offering significantly enhances Precision’s competitive positioning and our High Performance, High Value strategy.”
UAA = Met with Jeffries on November 22, 2019. Jefferies analyst Randal Konik said his recent meetings with Under Armour CEO Kevin Plank and incoming CEO Patrik Frisk left him confident that the company is well positioned for long-term growth and margin expansion and “ready to play offense again!” The company is becoming a better-run enterprise, with “clean” inventories, a shortened go-to-market process and enhanced design capabilities while its product roadmap looks “compelling,” Konik tells investors. He has a Buy rating and $22 price target on Under Armour shares.
On November 27, 2019, Raymond James analyst Matthew McClintock upgraded Under Armour (UAA) to Strong Buy from Outperform with an unchanged price target of $30, representing 67% upside. The shares closed Tuesday up 63c to $17.99. The analyst has become more comfortable with the company’s risk/return profile, particularly regarding execution risk and valuation. Under Armour is ahead of plan with new product already available at wholesale partners and selling through at higher level, McClintock tells investors in a research note. Further, after speaking to investors, the analyst believes the ongoing communication between Under Armour and the Securities and Exchange Commission/Department of Justice is likely less to be an overhang to the stock than he originally feared.
AAXN = Axon (Nasdaq: AAXN), the global leader in connected public safety technologies, and its subsidiary Axon Public Safety Canada Inc., today announced the Halton Regional Police Service (HRPS) as the first law enforcement agency in Canada to partner with Axon for its virtual reality (VR) empathy training program through Axon Academy, a network of online and in-person training for law enforcement. HRPS has received 20 Oculus Go headsets to begin training their internal teams and will officially launch their program in the first quarter of 2020.
HRPS is deploying Axon’s VR empathy-based training in an effort to increase community safety following an increasing number of mental health calls seen in the region. The program provides officers with an immersive training experience where trainees can put themselves in the shoes of both the officer responding to the scene and the person in crisis. With this deployment, HRPS will have access to three different VR training scenarios that Axon currently offers: autism, schizophrenia and suicide empathy training. The agency will also gain access to future training scenarios as they are developed.
“Axon’s innovative empathy-based training will complement our existing training program and further enable our frontline officers to manage and de-escalate potentially high-stakes interactions,” says Deputy Chief Roger Wilkie, the Halton Regional Police Service. “This partnership with Axon will ultimately serve to bolster community safety and well-being.”
Raymond James analyst Brian Gesuale downgraded Axon two notches, to Market Perform from Strong Buy, as he believes the stock’s “unsustainable energetic move higher” this month cannot be reconciled with fundamentals of the business. The stock has rallied about 50% in the last three weeks without any increases to his model, noted Gesuale, who said “some of this can be chalked up to short covering and a technical breakout.” However, he adds that it is hard to know when those catalysts will run their course and the stock’s positive momentum will reverse.
ADSK = Moving higher after quarterly report showed beats but they pulled forward sales from Q4, an analyst warns. Lots of bullish analyst commentary after earnings report.
Autodesk reports Q3 non-GAAP EPS 78c, consensus 72c. Reports Q3 revenue $843M, consensus $825.77M.
“Our strong performance continued in Q3 as revenue, billings, ARR, earnings and free cash flow came in above expectations,” said the company. “We continue to demonstrate the cash generating power of our business model, and this quarter drove a record last twelve months free cash flow of nearly $1B. The breadth and depth of our product portfolio in Construction paved the way for another strong quarter. In Manufacturing, we continue to displace competitors and grow faster than the overall market. Q3 results were driven by all regions and products, and once again drove robust margin expansion. Outstanding execution, our resilient subscription business model and steady demand for our products produced billings over $1B, a 55% year-over-year growth.”
Stifel analyst Adam Borg raised his price target for Autodesk to $190 from $160 saying the company delivered a “solid” fiscal Q3 print, with all key metrics above guidance and expectations. Importantly, Autodesk offered an early look into fiscal 2021 and expects revenue and free cash flow to each grow above 20% year-over-year, which is in-line with consensus and “better-than-feared,” Borg tells investors in a research note. He continues to believe Autodesk remains well positioned across end markets and reiterates a Buy rating on the shares.
Barclays analyst Saket Kalia raised his price target for Autodesk to $195 from $173 saying last night’s Q3 results were better than expected. The fiscal 2020 annual recurring revenue guide is going down for mechanical reasons, not fundamental, Kalia tells investors in a research note. Further, he believes Autodesk’s preliminary fiscal 2021 view on free cash flow “squashes a bear point” on long term deferred comparable next year and sets a reasonable cadence through fiscal 2023 for growth. Kalia keeps an Overweight rating on the shares.
Mizuho analyst Matthew Broome raised his price target for Autodesk to $195 from $190 saying the company reported better than expected fiscal Q3 results, with “very strong” billings, and “good upside” to revenue and earnings. The analyst sees “multiple long-term growth drivers” that should help Autodesk continue to outperform underlying market growth rates. He keeps a Buy rating on the shares.
Credit Suisse analyst Brad Zelnick raised his price target for Autodesk to $185 from $175 saying the company reported “solid” Q3 results. He reiterates a Outperform rating on the shares.
Wedbush analyst Steve Koenig said Autodesk outperformed on all major metrics in Q3, but also noted that the strong Q3 results were helped by early closes of some Q4 deals with upfront revenue recognition. Billings results were “spectacular,” added Koenig, who said the primary negative in the quarter was a reduction in Q4 ARR and revenue guidance that came in below consensus. Given the “many moving parts” that don’t support confidence in meeting prior FY20 objectives, Koenig keeps a Neutral rating on Autodesk shares, though he raised his price target on the stock to $171 from $162 given his higher free cash flow estimates.
Oppenheimer analyst Koji Ikeda raised his price target for Autodesk to $200 from $175 saying the company reported “good” Q3 results and increased the full year free cash flow guidance. He believes Autodesk continues to perform well in a “shaky macro environment” and maintains an Outperform rating on the shares.
RBC Capital analyst Matthew Hedberg raised his price target on Autodesk to $189 and kept his Outperform rating after its Q3 earnings beat and narrowed higher FY20 guidance midpoint. The analyst says the company is making progress around “construction, manufacturing and monetizing its non-paying users”, while also citing its maintained annualized recurring revenue guidance that followed “rightsizing for some shift to upfront revenue, product-mix, and FX”. Hedberg remains positive on Autodesk given the improving macro backdrop, his higher conviction in the model transition and free cash generation, as well as the company’s ability to expand its Annualized Revenue Per Subscription metric.
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