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Friday, July 19, 2019

FDA tentatively OKs Amneal’s generic Otezla

The FDA tentatively approves Amneal Pharmaceuticals’ (AMRX -3.5%) marketing application for a generic version of Celgene’s (CELG -0.5%) psoriasis med Otezla (apremilast).
Tentative approval means that the application met the criteria for approval but patent issues need to be resolved before the agency grants full approval.

Intuitive Surgical’s Q2 Performance Lauded By Bullish Analysts


Intuitive Surgical's Q2 Performance Lauded By Bullish Analysts
Robotic surgical system manufacturer Intuitive Surgical, Inc. ISRG 0.52% reported above-consensus second-quarter results Thursday.

The Analysts

Canaccord Genuity analyst Jason Mills maintained a Buy rating on Intuitive Surgical and lifted the price target from $575 to $610.
Stifel analyst Rick Wise rates the shares a Buy, with a $570 price target.
Morgan Stanley analyst David Lewis reiterated an Overweight rating and $620 price target.
Cantor Fitzgerald analyst Craig Bijou reiterated an Overweight rating and $620 price target.
Raymond James analyst Lawrence Keusch maintained an Outperform rating and $610 price target.

Cannacord Recommends Adding To Positions

Intuitive’s top-line and bottom-line upside in the second quarter was achieved on the back of strong procedure growth, aided by an expanding geographic and procedure footprint, Mills said in a Thursday note.
The company narrowed its procedure growth guidance range from 15-17% to 16-17%, the analyst said.
The strong underlying trends support a bullish view on the stock, he said.
Mills said he expects the double-digit procedure growth to be sustained for several years to come.
Cannacord recommends adding to positions in the stock, attributing the positive stance to expected strong business trends in the form of robust procedure growth; expanding demand for systems; and strong revenue per procedure.

Stifel: Procedure Growth Guidance Could Prove Conservative

Intuitive’s higher procedure growth guidance is more modest than many previous guidance revisions, setting the company up for a second-half volume deceleration, Wise said in a Thursday note.
Many previous guidance hikes proved to be conservative, the analyst said.
Stifel predicted a negative stock reaction to the earnings report, as the company suggested hernia and colorectal procedure growth moderated despite overall healthy demand — while also suggesting operating expenditure investment will potentially limit EPS upside.
Wise sees these investments as measures to support broader new platform, commercialization, development/clinical initiatives and the building of global scale.

Morgan Stanley Eyes Competitive Pressure

Competitive concerns have weighed on stock performance since the first quarter, Lewis said in a Friday note.
Johnson & Johnson JNJ 0.73%‘s recent updates suggest a delay in its Verb system of about 18-24 months, and Medtronic PLC MDT 0.32%‘s likely to issue its next update in the fall, the analyst said.
“We continue to believe the technology gap between Medtronic Gen 1 and Intuitive’s ecosystems and pipeline is much wider than consensus appreciates.”
Morgan Stanley expects the overhang to persist, with volatility likely to create attractive entry points.
The average price of $477 at which the company repurchased $200 million worth of shares suggests a valuation floor for the stock, improving the risk-reward profile, Lewis said.

Cantor Confident In Intuitive’s Fundamentals

The premium Intuitive shares enjoy relative to peers is justified given its top-line growth profile, the building momentum of robotic surgery and a pipeline that can significantly expand its addressable market, Bijou said in a Thursday note.
The analyst raised his 2019 and 2020 EPS and revenue estimates for Intuitive.
“We remain confident in ISRG’s underlying fundamentals and momentum and maintain our longterm positive view on ISRG, anchored by the long-term growth potential of SP and ION.”

RayJay: ‘We Remain Constructive’

Solid underlying system placements were somewhat obscured by operating leases, Keusch said in a Friday note.
The analyst said he is supportive of flexible financing options given the increased visibility of future cash flows.
Keusch also pointed to the better-than-expected procedure growth and capital placements, both of which are considered important metrics.
“We remain constructive on ISRG shares, given a multi-year new product cycle, geographic expansion, and robotic surgery moving into mainstream adoption, plus significant balance sheet optionality with a $5B in net cash position.”
Although investors are concerned about competition in 2020, Raymond James said it is already discounted in the stock. The firm said it would buy the stock following the robust second-quarter performance.

Afya Opens Above IPO Price

Afya NASDAQAFYA made its public debut Friday morning, opening at $23.50 after being priced at $19 per share.
The company has listed its shares on the Nasdaq under the symbol AFYA.
Afya is a medical education company, delivering an end-to-end physician-centric ecosystem serving medical students through their medical residency preparation, graduation program and continuing medical education activities.
Bank of America Merrill Lynch, Goldman Sachs, UBS and Itau BBA are the global coordinators for the offering.

Pfizer Canada to manage EpiPen distribution ahead of possible shortage

As a precautionary measure to assure supply, Pfizer Canada (PFE), the manufacturer of Mylan’s (MYL +0.9%) emergency allergic reaction med EpiPen (epinephrine injection), will take over distribution as it tries to sidestep a potential shortage of the 0.3 mg formulation there. At present, it has a supply of product and shipments are continuing, adding that the issue should be resolved by early October.
EpiPen Jr (0.15 mg) is not affected.

CTI to start Phase 3 for myelofibrosis med in Q3

CTI BioPharma Corp. (Nasdaq: CTIC) (‘CTI’ or ‘the Company’) today announced the outcome of a Type B, End-of-Phase-2a meeting with the U.S. Food and Drug Administration (‘FDA’ or ‘the Agency’) for the continued development of its investigational myelofibrosis treatment candidate, pacritinib.
Following this meeting, CTI plans to evaluate 200 mg of pacritinib administered twice daily (BID) in 180 patients with myelofibrosis and severe thrombocytopenia. The Company plans to initiate the Phase 3 PACIFICA study in the third quarter of 2019.
‘We are pleased to be able to move the pacritinib program forward and are now in the process of finalizing an amendment to the PAC203 protocol, which the FDA will review, to allow a transition to the new PACIFICA Phase 3 study, in which we plan to compare the 200 mg BID dose of pacritinib to Physician’s Choice in myelofibrosis patients with severe thrombocytopenia, an important unmet medical need,’ said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. ‘We anticipate initiating the trial in the third quarter, which would put us on track for topline Phase 3 data in mid-2021.’

Key events next week – healthcare

Noteworthy events during the week of July 21 – 27 for healthcare investors.
SUNDAY (7/21): International AIDS Society Conference on HIV Science, Mexico City (4 days). Merck (NYSE:MRK): Data on MK-8591. ViiV Healthcare (NYSE:GSK)(NYSE:PFE)(OTCPK:SGIOY): Data from Phase 3 TANGO study on dolutegravir/lamivudine regimen in patients switching from TAF-containing three-drug regimen. Gilead Sciences (NASDAQ:GILD): 15 abstracts, including Descovy, Biktarvy, GS-6207 and GS-9620.
MONDAY (7/22): European Neurology Congress, London (3 days). Theravance Biopharma (NASDAQ:TBPH): Phase 2 data on ampreloxetine in symptomatic neurogenic orthostatic hypotension.
Mediwound (NASDAQ:MDWD): Analyst Day, NYC.
Marker Therapeutics (NASDAQ:MRKR): Conference call and webcast on Phase 1/2 data on MultiTAA in pancreatic adenocarcinoma.
WEDNESDAY (7/24): Crescita Therapeutics (OTC:CRRTF): Investor presentation webcast.
FRIDAY (7/26): American Society of Retinal Specialists Annual Meeting, Chicago (5 days). Clearside Biomedical (NASDAQ:CLSD): Multiple presentations on SCS Microinjector.

Health Insurance Innovations up on ruling for non-ACA-compliant plans

Online health insurance exchange operator Health Insurance Innovations (HIIQ +4%) is up on average volume in apparent response to a positive ruling by a judge regarding non-ACA-compliant health plans.