Consensus $433.73M. Cuts FY19 adjusted EBITDA view to $66M-$68M from $67M-$71M. The company states: “While the Company still expects direct-to-consumer sales to be its fastest growing channel, it plans to slow the pace of hiring in 2019 and place more emphasis on sales representative productivity. Inogen still expects international business-to-business sales to have a solid growth rate, but now expects domestic business-to-business sales to have a slightly negative growth rate. Given the difficult growth comparisons Inogen faces in the domestic business-to-business channel, the restructuring challenges of some providers, and its rental plan, it expects negative growth in the domestic business-to-business channel in the second quarter of 2019 compared to the second quarter of 2018, with modest growth in the back half of 2019 compared to the back half of 2018. Due to the ongoing restructure challenges some HME providers face, the company plans to continue to look for ways to partner with providers to drive portable oxygen concentrator adoption. Inogen now plans to slightly change its rental intake criteria to accept more new rental patient additions to increase access to patients who otherwise could not obtain a portable oxygen concentrator from their current homecare provider. Since rental reimbursement revenue is recognized monthly compared to the mostly immediate revenue recognition of direct-to-consumer sales, the company does not expect a meaningful rental revenue benefit from increasing its new rental setups until next year and beyond. While Inogen expects rental revenue to take time to ramp, the Company believes it can improve its close rate and lead usage by slightly changing its intake criteria on rental patients. Inogen continues to expect rental revenue to grow modestly in 2019.”
https://thefly.com/landingPageNews.php?id=2905175
Tuesday, May 7, 2019
Adaptimmune price target lowered to $6 from $16 at Raymond James
Raymond James analyst Reni Benjamin lowered his price target for Adaptimmune to $6 from $16, while reiterating an Outperform rating on the shares after the company presented Q1 financial results and provided a “major update” for the ongoing clinical programs. The analyst notes that preliminary results from synovial sarcoma patients treated at therapeutically relevant doses of ADP-A2M4 showed “promising results,” and that the company plans to initiate a Phase 2 SPEARHEAD-1 study of ADP-A2M4 in synovial sarcoma patients in the second half of 2019 and to initiate two additional studies to evaluate efficacy and durability of ADP-A2M4 and ADP-A2M10 with radiation in several solid tumor indications. Outside of synovial sarcoma, all other indications showed promising but mixed results, he added.
Aerie Pharma backs FY19 revenue view $110-120M, consensus $113.02M
Backs forecast for FY19 cash burn of $130M-$140M
Halozyme reaffirms FY19 revenue view $205M-$215M, consensus $209.09M
Sees FY19 revenue from royalties of $72M-$74M, with the decrease primarily attributable to the ongoing impact from biosimilars in Europe and updated expectations for the US launched products; product sales related to API increased to reflect additional customer orders; operating expenses of $265M-$275M, or $225M-$235M excluding an expected increase in cost of goods sold; operating cash burn of $45M-$55M; debt repayment of approximately $90Mm the company expects to pay off the remainder of the royalty-backed debt by the end of the Q1 of FY20; and year-end cash, cash equivalents and marketable securities balance of $210M-$220M.
Allakos announces ‘positive’ Phase 1 results for AK002
Allakos announced positive Phase 1 results in patients with severe allergic conjunctivitis. Patients administered AK002 reported a 78% median improvement in ocular symptoms by Allergic Conjunctivitis Symptom Score and a 71% median improvement in physician assessed signs and symptoms using the Ocular Symptom Score. In addition, patients suffering from comorbid atopic dermatitis, asthma and allergic rhinitis, despite treatment with currently available therapies, reported improvements in their symptoms while receiving AK002.
Fate Therapeutics reports Q1 EPS (30c), consensus (24c)
Reports Q1 revenue $2.63M, consensus $2.37M. “These past several months have been particularly inspiring for the Company, as we have delivered on our multi-year journey to be the first to bring iPSC-derived cell products to patients with cancer. We believe the ability to cost-effectively mass-produce cell-based cancer immunotherapies that can be safely delivered to patients ‘on demand’ in multiple doses has the potential to transform outcomes for many patients, especially when combined with therapeutic agents that have complementary mechanisms of action such as checkpoint inhibitors and monoclonal antibodies,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “We are very encouraged by the initial observations of safety and tolerability from the three patients who received multiple doses of FT500 in the first dose cohort, and we are excited with the initiation of the multi-dose checkpoint inhibitor combination arm where patients have previously progressed or failed therapy. In addition, we continue to make tremendous progress in advancing additional candidates from our off-the-shelf, iPSC-derived NK cell and T-cell product pipeline toward the clinic, and we look forward to generating initial clinical data with FT516 and FT596 in 2019.”
FDA Warns of Premature Battery Depletion in Some Medtronic Pacemakers
The U.S. Food and Drug Administration on Tuesday said it issued an alert about the potential for the batteries of certain Medtronic PLC (MDT) implantable pacemakers to drain more quickly than expected and without warning to patients.
The agency said it is aware of three events related to the issue, including one that resulted in the death of a pacemaker-dependent patient.
The FDA said about 132,000 of the devices have been sold in the U.S., adding that it isn’t currently recommending removal and replacement of the pacemakers due to the low frequency of device failure. Instead, the agency said patients and physicians should carefully monitor the battery status of the devices using home monitoring systems.
The alert covers several models of Medtronic’s Azure, Astra, Percepta, Serena and Solara pacemakers. The FDA said it recently approved improvements to Medtronic’s manufacturing process and a new component for newly made pacemakers.
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