Sarepta Therapeutics (NASDAQ:SRPT): Q3 Non-GAAP EPS of -$1.14 misses by $0.22; GAAP EPS of -$1.70 misses by $0.35.
Revenue of $99.04M (+26.2% Y/Y) beats by $0.55M.
Thursday, November 7, 2019
Cutera EPS misses by $0.04, beats on revenue
Cutera (NASDAQ:CUTR): Q3 GAAP EPS of -$0.19 misses by $0.04.
Revenue of $46.12M (+13.7% Y/Y) beats by $4.46M.
Tabula Rasa HealthCare EPS beats by $0.05, misses on revenue
Tabula Rasa HealthCare (NASDAQ:TRHC): Q3 Non-GAAP EPS of $0.22 beats by $0.05; GAAP EPS of -$0.39 beats by $0.03.
Revenue of $74.27M (+36.5% Y/Y) misses by $1.43M.
Teva: Opioid settlement will not derail ability to cut debt
Teva Pharmaceutical Industries Ltd on Thursday expressed confidence in its ability to continue paying down its huge debt burden even if it is forced to pay billions of dollars to settle thousands of U.S. opioid lawsuits.
Attorneys general of four U.S. states had agreed on a proposed settlement under which Israel-based Teva would provide $23 billion (£17.94 billion) worth of generic Suboxone and pay $250 million in cash over 10 years.
Reuters reported that the generic Subaxone that Teva plans to give away as part of its settlement will likely cost the company far less than the $23 billion figure put forth by Teva based on the way the drugmaker plans to account for the value of the treatment.
Teva Chief Executive Kare Schultz said such an agreement supports those suffering from drug addiction and is far preferable to many separate lawsuits by cities and counties.
“It also means that the burden to our cash flow will be over a 10-year period. That’s why it’s really possible for us to bring a significant benefit to society while still serving our debt and staying in business,” Schultz said in an interview with Reuters.
Teva’s debt load soared after it paid more than $40 billion in 2016 to buy Allergan’s generic drugs business.
Its debt load fell to $26.9 billion at the end of September from $28.7 billion three months earlier. At the same time, Teva said it remained on track to achieve a two-year restructuring target of $3 billion in spending reductions.
Schultz noted that Teva sought to refinance its debt schedule but not add to it and that any bond refinancing would not raise its interest rate burden over a manageable amount.
Teva, the world’s largest generic drugmaker, earned 58 cents per diluted share excluding one-time items in the July-September period, down from 68 cents a year earlier and largely in line with expectations.
Revenue fell 6% to $4.26 billion due to generic competition for its multiple sclerosis drug Copaxone and declines in sales in the United States, Russia and Japan, although it posted gains in some of its newly launched drugs.
Its shares, which had taken a beating this year, jumped 9.9% in New York after the company nudged up its full-year earnings guidance.
For 2019, the company raised its forecast for adjusted earnings per share (EPS) to $2.30-$2.50 from $2.20-$2.50 and revenue to $17.2 billion to $17.4 billion from $17.0 billion to $17.4 billion. Analysts are forecasting EPS of $2.38 on revenue of $17.18 billion.
Revenue in North America dipped 9% to $2.05 billion, with North American sales of Copaxone down 41% to $271 million. Its new migraine drug Ajovy had revenue of $25 million, while sales of Huntington’s treatment Austedo rose to $105 million from $62 million.
Schultz said that sales of Ajovy should get a boost from a new auto-injector delivery system it hopes will receive U.S. clearance in the next few months.
He said that 2020 will show a small increase in operating profit due to sales growth of Ajovy, Austedo and generic drugs, while the drag from lower Copaxone sales will largely subside.
Teva said it had legal settlements of $468 million in the third quarter, mainly in connection with U.S. opioid cases.
Teva also named Eli Kalif as its new chief financial officer effective Dec. 22.
The company is also being investigated by U.S. authorities for price fixing but Schultz said he believed there was no evidence of collusion.
Takeda’s Ninlaro successful in late-stage myeloma “switch” maintenance study
Takeda Pharmaceutical Company (TAK +1.2%) announces positive results from a Phase 3 clinical trial, TOURMALINE-MM4, evaluating Ninlaro (ixazomib) as first-line maintenance therapy in adult multiple myeloma patients who have not received stem cell transplantation. The study met the primary endpoint of progression-free survival versus placebo.
The company says this is the first industry-sponsored study to explore “switch” maintenance, the use of medicines not included in initial induction therapy.
No new safety signals were observed.
Final results will be submitted for presentation at a future medical conference.
Ninlaro is not currently approved for this use.
Juul ends mint-flavored product sales
Juul (JUUL) is halting the sale of mint-flavored products about a month after deciding to end fruit-flavored pod sales.
Mint pods account for about 70% of Juul’s U.S. sales, sources tip CNBC.
Last week, Altria (MO -0.3%) announced that it’s writing down its investment in Juul by $4.5B, but it’s unclear if that amount factors in the loss of mint-flavored products.
Sensus Healthcare Reports Third Quarter 2019 Financial Results
Sensus Healthcare, Inc. (Nasdaq: SRTS), a medical device company specializing in highly effective, non-invasive, minimally-invasive and cost-effective treatments for oncological and non-oncological conditions, announces financial results for the three and nine months ended September 30, 2019.
Highlights from the third quarter of 2019 and recent weeks include:
- Launched Sculptura™ Modulated Robotic Brachytherapy with Beam Sculpting™ capabilities and Robotic Respiratory Tracking (Sculptura) at several important medical conferences including the American Society for Radiation Oncology (ASTRO) and the American Association for Physicists in Medicine (AAPM)
- Received regulatory clearance for the SRT-100™ in Korea
- Continued work with key advocates to improve Centers for Medicare and Medicaid Services (CMS) reimbursement for superficial radiation therapy (SRT)
- Premier, Inc., with approximately 4,000 member hospitals and health systems across the U.S., added SRT to its group purchasing contracts effective August 1
- Increased worldwide installed base of SRT systems to approximately 450 systems
- Shipped 16 SRT systems including 14 SRT-100 Vision™ systems during the third quarter
- Delivered three of five planned SRT-100+ systems to a large dermatology group
- Reported revenues of $5.8 million compared with $6.3 million for the third quarter of 2018
- Cash and investments as of September 30, 2019 were $14.9 million, with no debt
Management Commentary
“The third quarter and recent weeks were highlighted by our launch of Sculptura at major medical conferences, as we took important initial steps to build awareness for the capabilities of this important product,” said Joe Sardano, Sensus Healthcare’s chairman and chief executive officer. “We had a larger presence at this year’s ASTRO trade show, the foremost meeting of radiation oncologists that took place in September, and were delighted with the interest shown by potential customers. Prior to that, our showcasing of Sculptura at the AAPM meeting and at the American Brachytherapy Society’s Annual Meeting generated excitement among physicians and physicists for its new features and technology. We are very pleased with the work of our oncology team and the interest being generated in this recently approved product.
“Our research agreement with the Perelman School of Medicine at the University of Pennsylvania is moving forward as planned, with patient treatments set to begin by the first quarter of 2020. This research will support Sculptura marketing and help expand the indications for use in late 2020 and beyond. We continue to work with leading academic hospitals to place Sculptura and expect up to three more systems to be sold by the end of the year.
“Earlier this year Sensus was notified that SRT was added to Premier’s group purchasing contracts effective August 1, 2019 for the Oncology market. Premier has 4,000 member hospitals and health systems throughout the U.S., and we have begun making inroads. Premier represents a fruitful avenue for growth.
“We continued our efforts to improve CMS reimbursement for SRT and have been actively engaged to push for a revaluation of our main code, 77401. While CMS has made public that this code is due for revaluation based on current criteria, the agency is sticking to revalue by 2021 as they have previously declared. Our expectation is that a new rate will be set for 2021 and we expect to know that rate this time next year. The anticipated higher rate should accelerate future SRT-100+ and Vision sales in the U.S. as it will provide much needed clarity and direction.
“We continued to invest in sales and marketing, and exhibited our SRT systems for the treatment of keloids and non-melanoma skin cancer at several regional dermatology trade shows. During the quarter, our SRT-100+ was featured on a popular dermatology cable TV program, where a young woman’s keloids were treated successfully on-air. We expect the SRT-100+ to continue to be featured on this show, which is hosted by Dr. Sandra Lee. The show should support continued exposure for SRT to treat keloids, particularly given a recent clinical study showing just a 3% recurrence rate after surgery and SRT.
“We shipped 14 Vision systems and 2 SRT-100s during the quarter. We also began shipments of SRT-100+ systems to a large dermatology practice in a shared-revenue program,” Mr. Sardano added.
“Our international results were mixed. While we received clearance from Korea and regulatory approvals in new large markets including Brazil and India are in process, our sales efforts in China have not gone as planned and impacted Q3 revenues. The current geopolitical upheaval with China has temporarily cooled our expectations for that market, but we are optimistic that the U.S. and China will soon reach an agreement to resolve the current trade dispute.
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