B. Riley FBR analyst Mayank Mamtani earlier today added Intercept Pharmaceuticals (ICPT) to his firm’s Alpha Generator list. The analyst sees “strong” strong fundamentals over next year and a high likelihood of FDA approval in mid-2020. Mamtani lowered his price target for Intercept to $158 from $169 and keeps a Buy rating on the shares. His new target reflects the company’s recent capital raise, the removal of removing Gilead (GILD) as near-term competitor with selonsertib’s recent failure, and the push out of a European launch from the second half of 2020 to Q1 of 2021.
Friday, May 10, 2019
Thursday, May 9, 2019
Planet Fitness Plans Expansion, Targeting Sites of Retailers Who Went Under
Gym chain Planet Fitness is planning to open a total of 225 new locations this year, some of which will be in sites formerly occupied by Toys R Us or Sears, though the company has not specified where all of those locations will be.
For Planet Fitness, retail closures can mean opportunities for new locations.
“Looking ahead, real estate trends appear to remain in our favor as many brick-and-mortar retailers continue to close stores and landlords are increasingly looking to Planet Fitness as key tenants who drive traffic to their centers,” Planet Fitness CEO Chris Rondeau said during the company’s quarterly earnings call in February.
Last year, Rondeau articulated a similar notion when he said that the gyms drive traffic and “we can’t be Amazoned.”
Planet Fitness is currently working with retailers who are looking to downsize in markets in which the gym chain is looking to expand, according to Rondeau. Toward that end, the company has hired a handful of in-house real estate brokers to source sites.
Recently the Hampton, New Hampshire-based fitness specialist announced a collaboration with retailer Kohl’s to open as many as 10 Planet Fitness locations adjacent to Kohl’s stores in 2019, and perhaps more after that. During the company’s Q1 2019 earnings call this month, Rondeau said those locations will occupy about 20K SF to 25K SF each in various markets nationwide.
“This complementary partnership made strategic sense to both brands,” Rondeau said. As Planet Fitness continues to grow, pairing with Kohl’s is an opportunity to introduce shoppers to the company’s fitness concept, while simultaneously driving traffic to Kohl’s stores.
In fact, Rondeau said, his company’s research shows that its members tend to stay nearby for shopping after visiting a Planet Fitness. Seventy-six percent of members combine gym visits with other shopping, the gym says, while 89% of members shop at other retailers within their gym’s shopping center.
“In today’s retail landscape, we believe our differentiated approach to fitness continues to drive traffic to our shopping centers across the country, which is why partners like Kohl’s are interested in looking at a PF become tenants in their centers,” Rondeau said.
The company has already gotten off to a strong start this year, opening 65 locations during the first quarter, and ending Q1 with more than 13.6 million members and more than 1,800 locations.
Planet Fitness’s first-quarter 2019 revenues of $148.8M represented a 22.7% increase year over year, and the company expects a 15% increase for the full year. Same-store sales were up 10.2% compared with a year ago, the latest quarter in 12 straight years of annual sales growth. Investors are responding. Shares of Planet Fitness have ballooned by more than 400% over the last four years.
While Planet Fitness was mum on exactly where the 225 gyms will go, it announced five locations in Northern Virginia Wednesday, all filling suburban big-box vacancies.
Joint Corp. sees FY19 revenue up 26%-32%, consensus $40.72M
Adjusted EBITDA to grow between 67% and 100%, compared to $2.9 million in 2018 and Company-owned or managed clinic expansion, through a combination of both greenfields and buybacks, to range from 8 to 12.
PTC Therapeutics, MRI Interventions announce strategic investment
PTC Therapeutics and MRI Interventions announced a strategic equity investment, with PTC purchasing $4M in shares of MRI common stock. PTC and MRI have also entered into a supply agreement for MRI’s neurosurgical devices for PTC’s current and future gene therapy programs. MRI is a platform neurosurgery company developing products designed for navigation, ablation, deep brain stimulation, biopsy, aspiration and gene therapy. PTC Therapeutics and certain other accredited investors have entered into a securities purchase agreement to purchase MRI Interventions’ common stock for a purchase price of $3.10 per share. Closing of the transaction is expected to occur on May 17. Effective upon closing of the transaction, PTC Therapeutics, as the lead investor, will also receive the right to participate in future financings by MRI Interventions in addition to certain registration rights pursuant to the terms of the securities purchase agreement. In addition, PTC Therapeutics will also receive the right to designate a director nominee for MRI Interventions’ board of directors for so long as PTC Therapeutics’ satisfies certain conditions as set forth in the securities purchase agreement. PTC Therapeutics initial director nominee, which MRI Interventions’ board of directors has resolved to appoint to serve as a director on the board of directors of MRI Interventions, effective as of the closing of the transaction, will be Marcio Souza, COO of PTC Therapeutics.
FibroGen has topline results from pooled analyses of roxadustat Phase 3 program
FibroGen (FGEN) announced topline results from the pooled safety analyses of the global Phase 3 program for roxadustat, an inhibitor of hypoxia-inducible-factor, or HIF, prolyl hydroxylase activity, or HIF-PHI. The global pivotal Phase 3 trials were conducted by FibroGen and collaboration partners AstraZeneca (AZN) and Astellas Pharma (ALPMY), for treatment of anemia in chronic kidney disease, or CKD, patients across the non-dialysis-dependent, or NDD, incident dialysis, and dialysis-dependent, or DD, CKD populations, enrolled from more than 50 countries. These pooled analyses of adjudicated events for safety assessment of roxadustat are part of the overall benefit-risk assessment. For the planned new drug application, or NDA, submission to the FDA, one of the safety endpoints to be evaluated is Major Adverse Cardiac Events, or MACE, a composite endpoint of all-cause mortality, stroke and myocardial infarction, in pooled analyses against placebo in NDD and against epoetin alfa in DD from the pivotal Phase 3 trials. The NDA submission package to the FDA will be based on the totality of evidence, and the company will continue to discuss the specific statistical standards with the FDA. For the European Medicines Agency, it was agreed that the primary safety assessment is MACE+, a composite endpoint of MACE plus heart failure requiring hospitalization and unstable angina requiring hospitalization. In the pooled analyses of around 4,000 dialysis patients, the upper bound of the 95% confidence interval was below the pre-specified non-inferiority margin for the time to first MACE+ analyses. Based on the MACE safety analyses of this population, the company believes there is no clinically meaningful difference in risk of MACE between roxadustat and epoetin alfa. The roxadustat global Phase 3 program enrolled over 1,500 incident dialysis patients, a subpopulation of DD-CKD population, which the company believes offers a better setting for comparing roxadustat to epoetin alfa than the stable dialysis population, that is stable on both dialysis and erythropoiesis stimulating agent. Roxadustat demonstrated superiority to epoetin alfa in the time to first MACE+ in this subpopulation. In the MACE analysis, there is a trend toward reduced risk for patients on roxadustat, compared to epoetin alfa. In the non-dialysis pool of approximately 4,300 patients, non-inferiority was demonstrated for roxadustat compared to placebo in the time to first MACE+, based on the upper bound of the 95% CI being below the prespecified non-inferiority margin. Based on the MACE safety analyses of this population, the company believes there is no clinically meaningful difference in risk of MACE between roxadustat and placebo. Of note, multiple MACE and MACE+ analyses in NDD-CKD from the roxadustat global Phase 3 program are being performed in intent-to-treat analyses that demonstrated comparability of roxadustat to placebo. ITT is among the several statistical methods that the company will discuss with the FDA. In these analyses, roxadustat was comparable based on a commonly applied non-inferiority margin of 1.3.
Medtronic to acquire Tital Spine
Medtronic plc (NYSE: MDT), a global leader in medical technology, today announced that it has entered into a definitive agreement pursuant to which it will acquire Titan Spine, a privately-held titanium spine interbody implant and surface technology company. The boards of directors of both companies have unanimously approved the transaction. Terms of the transaction are not being disclosed.
Interbody implants are spacers that can be inserted between the vertebrae during spinal fusion surgery to help relieve pressure on nerves and hold the vertebrae in place while fusion occurs. Implant material and shape is thought to play a role in the bone growth process during fusions, and today there is a growing demand from surgeons for titanium interbody devices.
“We’ve built the broadest Spine portfolio – implants, instruments, enabling technologies, and biologics – in order to provide complete procedural solutions for surgeons’ biggest challenges,” said Jacob Paul, senior vice president and president of the Spine division, which is part of the Restorative Therapies Group at Medtronic. “Titan Spine has pioneered the spine implant surface technology category over the past several years. We feel that surface-enhanced titanium implants combined with our comprehensive biologics portfolio can have a positive impact on patient outcomes in spinal procedures.”
Medtronic’s acquisition of Titan Spine strengthens Medtronic’s position as a leading innovator in procedural solutions for spine surgery. In bringing the two companies together, Medtronic will acquire Titan Spine’s complete portfolio, which consists of a comprehensive line of titanium, surface-enhanced interbody fusion devices.
Emergent BioSolutions price target lowered to $61 from $68 at Wells Fargo
Wells Fargo analyst David Maris lowered his price target on Emergent BioSolutions to $61 and kept his Market Perform rating after its miss on Q1 revenue and earnings last week. The analyst also lowers his FY19 and FY20 EPS outlook by 7c and 41c to $3.01 and $3.27 respectively, reflecting the delays in its negotiations for a follow-on contact for its AMAC2000 Smallpox Vaccine and the management’s expectations for its FY19 earnings to be “even more heavily back half weighted.”
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