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Thursday, August 8, 2019

Merck KGaA’s profit bolstered by lab supplies, drug milestone payments

Germany’s Merck KGaA posted a gain in quarterly earnings that was slightly higher than market expectations thanks to strong sales growth at its lab supplies unit and milestone payments from drug development partners.

Second-quarter earnings before interest, taxes, depreciation and amortisation (EBITDA), adjusted for special items, gained 23.8% to 1.14 billion euros (£1.05 billion), Merck said on Thursday, slightly above the analyst estimate of 1.11 billion euros in a Refinitiv poll.
Merck’s Life Science unit, which makes supplies and gear for the biotech industry, saw adjusted EBITDA gain 18 percent to 533 million euros, driven by demand for gene editing technology and water purification, among other processing tools.
The unit is benefiting from a race in the drug industry to develop new treatments.
Adjusted EBITDA at Merck’s own pharmaceuticals business jumped 39% to 528 million euros, helped by agreed payments from partners Pfizer for achievements in developing cancer drug Bavencio and GlaxoSmithKline for advancing novel cancer immunotherapy bintrafusp alfa.
Merck confirmed its guidance for an underlying increase of 10-13% in 2019 EBITDA and adjusted for one-off items but now sees a positive effect of 0% to +2% from currencies.

Siemens Healthineers to buy U.S. firm Corindus for $1.1B

Siemens Healthineers has agreed to buy Corindus Vascular Robotics for $1.1 billion (£903.7 million) in the biggest acquisition since the Siemens subsidiary listed on the stock market last year.

Healthineers is paying $4.28 per share for Massachusetts-based Corindus, which develops robotic systems for minimally invasive vascular therapy procedures, a 77% premium to the U.S. company’s closing price on Wednesday.
Systems produced by Corindus, which has approximately 100 employees, allow doctors to guide catheters and stent implants with controlling modules.
Corindus made a loss of $35 million last year on revenue of $10.8 million. But Jochen Schmitz, Healthineers’ finance chief, told analysts on Thursday he expected the unit to post a profit in 2023.
Corindus’ board has approved the deal, Corindus said in a statement, but the deal is still subject to shareholder agreement.
“We believe the transaction will deliver immediate, compelling and certain value to all Corindus stockholders,” Corindus Chief Executive Mark Toland said.
Rival Philips is the second-largest shareholder in Corindus with a 12.8% stake, according to Refinitiv data. Healthineers’ Schmitz said he doesn’t expect a counter bid from the Dutch company.
A Philips spokesman said the company was reviewing the announcement and wouldn’t comment further.
In 2015, Philips bought U.S. medical equipment maker Volcano, specialized in equipment for minimally invasive surgery, for $1.2 billion, strengthening its position in image-guided therapies.
Siemens and Corindus said the deal is expected to close by the end of the year.

Vifor Pharma AG reports 1H results

Vifor Pharma AG (OTCPK:GNHAF): 1H Non-GAAP EPS of CHF2.11.
Revenue of CHF913.3M (+22.2% Y/Y)

Wednesday, August 7, 2019

Planet Fitness Boosts Plans for More Gyms

Chain Puts More ‘Boots on the Ground’ to Locate Sites

A Planet Fitness built two years ago in Joplin, Missouri. (CoStar)
A Planet Fitness built two years ago in Joplin, Missouri. (CoStar)
Planet Fitness has broken out in the health and wellness sector to become a highly sought-after tenant. And now, the New Hampshire-based chain plans to deliver more locations this year than originally planned.
In its latest earnings report, the company said it planned to open 250 to 260 new locations this year. That’s up from the 225 locations leadership had projected earlier this year. It opened 230 locations last year.
“Planet Fitness continues to leverage a size and scale to capitalize on current real estate trends and dominate the market where we operate,” Chris Rondeau, Planet Fitness CEO, said on the company’s earnings call.
Planet Fitness opened 53 new franchise locations in the second quarter alone, putting the total count at 1,859. Locations typically occupy about 20,000 square feet.
New locations have helped increase the company’s revenue. It reported $181.7 million in the second quarter, a more than 29% increase from last year. A key figure is same-store sales, which increased 8.8%. Through the first six months of the year, net income climbed from nearly $54 million to more than $71 million.
Rondeau said the new guidance on store locations reflects strong financial backing of franchisees and their growing sophistication in expanding within their territories.
But it’s also in how Planet Fitness has approached finding real estate for new locations. Over the past year, “we put more boots on the ground where we’re working with the commercial real estate brokers for the landlords,” said Dorvin Lively, the company’s president.
Three or four years ago, “we were basically letting franchisees bring sites to us” for approval, Lively said. “And in many cases, we would decline the sites.”
In addition to the real estate move, Lively noted the chain is now a highly sought-after tenant, unlike four or five years ago. “We weren’t No. 1 on the calling list when something was coming up,” he said.
Though founded in 1992, the chain didn’t start selling franchises until 2003, and it took a while for the business to take hold as a franchise. It helps that consumers are increasingly seeking new health and wellness options. It also helps that, as more and more traditional retailers close, the owners of shopping centers have become more receptive to leasing space to gyms, salons and other ventures that can generate regular foot traffic and face little competition online.
A prime example is Planet Fitness’ recent deal with discount department store chain Kohl’s. Kohl’s announced earlier this year that it would lease space next to its department stores to Planet Fitness. The goal is to generate more traffic for the retailer.
If successful, Kohl’s, which has more than 1,100 stores around the country, said the program could expand.
Rondeau said the company is on track to open five by the end of the year, four franchises and one corporate-owned, with more to come next year.

AxoGen Q2 conference call

Operator
Thank you. At this time, we’ll be conducting a question-and-answer session. [Operator Instruction] our first question comes from Richard Newitter with Leerink Partners. Please state your question.
Richard Newitter — Leerink Partners — Analyst
Hi. Thanks for taking the questions. Karen and Pete, I was hoping maybe we could just start off with, guidance. I appreciate that the quarter came in toward the low end, you’re at low end year range, but maybe you could just keys out for us. What exactly it is being delayed by productivity gains and what gives you kind of visibility into, I guess the future productivity contemplation that you have in your guidance for the back half that this is the right range. It feels like productivity and sales force related issues have kind of made a little bit challenging to forecast the business.
So, help us understand what’s contemplated in your guidance in the back half, maybe even between the third quarter and the fourth quarter. What exactly led to the delays and what gives you confidence that you have visibility into the back half and for the new full-year target. Thanks.
Karen Zaderej — Chairman, Chief Executive Officer, and President
Sure. Thanks, Rich. So, we’ve demonstrated that as you take these territories and make them smaller and more geographically dense so we can generate both better productivity and high growth in those territories. And that’s what we’re looking to replicate across more metropolitan areas. At the same time, we’re taking some of the geographically diffuse cities and moving those to independent agencies. So there is some moving pieces in both geography and our percents of revenue to make these changes happen. We see that as a strong footing and platform for continued long-term growth.
The transition, if you looked at our original guidance, was that we would remain flat. We see the — productivity has remained relatively flat with our direct reps, and we’ve not seen the uptick that we expect to see — that we would originally hope to see in the full year, but we think it’s a timing thing. Because as we look back at territories that we’ve done this previously, we do see how they come up when you give that good concentration allowing the reps to focus. And just from a practical matter, you can see how that would happen in that it reduces driving time for the rep, they’re not driving out to cover a trauma case that might be five or six hours from their house, instead they are focusing on the territory on the high value accounts or are close to their home where they can spend more time and having better touch points with their surgeons so that we don’t lose surgeons during their wait period and we can continue to drive penetration in those accounts.
[MORE]

Rexahn Reports 2Q Results and Provides Update on RX-3117 Development

Rexahn Pharmaceuticals, Inc. (NasdaqCM: REXN), a clinical stage biopharmaceutical company developing innovative therapies to improve patient outcomes in cancers that are difficult to treat, today announced financial results for the three and six months ended June 30, 2019 and provided an update on RX-3117 development.
Recent Highlights and RX-3117 Development Updates:
  • Announced a collaboration and license agreement with BioSense Global LLC, a New Jersey- and Suzhou, China-based biopharmaceutical company, to advance the development and commercialization of RX-3117 for pancreatic and other cancers in Greater China. Under the agreement, Rexahn will receive an upfront payment, a portion of which has been paid, and will be eligible to receive up to $126 million in development and regulatory milestones and up to $100 million in commercial milestones for each product containing RX-3117, contingent on achieving commercial goals.
  • As of July 24, 2019, an overall response rate of 23% has been observed in 40 patients that have had at least one scan on treatment in the Phase 2a study of RX-3117 in combination with ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) in patients newly diagnosed with metastatic pancreatic cancer. The Company previously reported in January 2019 an overall response rate of 38% in the first 24 patients who had at least one scan on treatment. Preliminary and unaudited data indicates that the median progression free survival for patients in the study is approximately 5.4 months.  Patients currently active in the study will continue to be treated and final data from the trial is expected to be available in 2020.
  • Transferred its stock exchange listing to the Nasdaq Capital Market from its previous listing on NYSE American.
  • Effected a 1-for-12 reverse stock split of outstanding shares on April 12, 2019.
  • As of August 7, 2019, had approximately $15.3 million in cash, cash equivalents, and marketable securities (unaudited). Rexahn expects that its cash, cash equivalents and marketable securities will be sufficient to fund the company’s currently expected cash flow requirements for its activities for at least the next 12 months.
“We are surprised and disappointed with the most recent preliminary data from the ongoing Phase 2a trial of RX-3117 in combination with ABRAXANE in first line metastatic pancreatic cancer patients,” said Douglas J. Swirsky president and chief executive officer of Rexahn. “RX-3117 appears to be well tolerated and we are evaluating development options for RX-3117 in other indications, including through our collaboration with BioSense.  In the near term, we are focused on supporting our collaborations with BioSense and Zhejiang Haichang Biotechnology Co., Ltd. as we evaluate the best path forward for our programs.”

Demand for bulletproof backpacks surging in the wake of shootings

Bulletproof backpacks are reportedly rising in popularity as shootings increase across the nation and in the wake of two weekend massacres that left more than 30 people dead.
More companies are offering bulletproof backpacks for students as they gear up to go back to school as a means of protection if a potential threat were to enter their classroom, The New York Times reports.
The shields, which can cost up to $200, started becoming more in-demand after the Parkland, Fla., school shooting in 2018. After the El Paso, Texas, and Dayton, Ohio, shootings over the weekend, the products are back in the spotlight — especially as many students are days and weeks away from the new school year.
J.T. Lewis, a 19-year-old student at the University of Connecticut and the brother of one of the Sandy Hook Elementary School shooting victims, carried an armored backpack on campus to make him feel safer, the Times reports.
“I don’t know if it’s going to have any effect,” Lewis, who’s running for a seat in the Connecticut State Senate, told the Times. “But it might if I get shot from behind.”
Multiple companies, including Guard Dog Security — which has been marketing the product since the Newtown, Conn., shooting in 2012 — and ArmorMe have been selling the gear in stores such as Office Max, Office Depot and Kmart, the Times reports.
Other companies have sold protective panels that could be placed into a backpack.
“It could be the difference between life and death,” Yasir Sheikh, who runs Guard Dog, told the Times.
Since the Parkland massacre, there’s been, on average, one school shooting every 12 days, according to CNN, leading to gun control advocates speaking out in defense of tighter gun laws.