Piper Jaffray analyst Tyler Van Buren said Bluebird Bio made substantial progress in Q2 and reported what he believes were very positive datasets across its key development programs. The analyst, who contends that Bluebird is “entering an exciting period of time,” recommends that investors own the shares to realize the additional value that will be generated from LentiGlobin, bb2121(7), and Lenti-D as the company has the potential for its first three product approvals over the period of 2019-2020. Van Buren maintains an Overweight rating on Bluebird Bio shares.
Thursday, August 2, 2018
Cross Country Healthcare hit post Q2 results
Segment revenue: Nurse and Allied Staffing $179.3M (-1% Y/Y); Physician Staffing $21.3M (-14% Y/Y) & Other Human Capital Management Services $3.9M (+6% Y/Y).
Contribution income: Nurse and Allied Staffing $16.9M (-6.6% Y/Y); Physician Staffing $1.4M (-30% Y/Y) & Other Human Capital Management Services $0.3M (+50% Y/Y).
Average Nurse and Allied Staffing revenue per FTE per day of $276; Average field FTEs were 7,143 (-0.2% Y/Y).
For Physician Staffing, days filled were 13,751 (-12.4% Y/Y) & revenue per day filled $1,551.
Gross profit margin declined 80 bps to 26.2%.
Adj. EBITDA margin declined 96 bps to 4.25%.
CFO was $4.7M (-80.5% Y/Y).
The Company had $32.6M in cash and quivalents and a $97.5M term loan, par value, outstanding under the term loan.
Repurchased 157,056 shares of common stock for $1.8M, at an average market price of $11.53 per share.
Q3 Outlook: Revenue: $195-205M; Gross profit margin of 25.5-26%; Adj. EBITDA $8-9M & Adj. EPS $0.02-0.04.
Epizyme Halts Phase 2 Trial, Continues Talks to Lift Clinical Hold
Epizyme said today it will halt a Phase II clinical trial assessing its lead candidate, the cancer treatment tazemetostat in relapsed and/or refractory diffuse large B-cell lymphoma (r/r DLBCL).
The trial halt comes more than three months after the FDA imposed a partial clinical hold on tazemetostat stemming from a separate trial—a hold that the company said it is working to have lifted.
The company said it will end its Phase II trial evaluating tazemetostat as monotherapy in cohorts of patients with r/r DLBCL (NCT01897571). The cohorts include DLBCL patients who have received tazemetostat in combination with prednisolone; as well as cohorts of DLBCL patients with EZH2 activating mutations, and with wild-type EZH2 who have been receiving tazemetostat as monotherapy.
“Epizyme has conducted an interim assessment of data from this trial and concluded that the clinical activity seen in these cohorts is not sufficient to warrant further development of tazemetostat in DLBCL as a monotherapy or in combination with prednisolone,” the company said in a statement, tucked within its announcement of second-quarter results. Epizyme finished Q2 with a net loss of $29.128 million, up from a net loss of $28.024 million in the year-ago quarter.
Epizyme added that it plans to present clinical data from each of the study cohorts at a medical meeting later this year. The company has two additional combination studies in DLBCL ongoing and plans to evaluate other potential combinations in this aggressive and difficult-to-treat cancer longer term.
The terminated trial was designed to assess tazemetostat in non-Hodgkin lymphoma (NHL), of which DLBCL is the most common form. Other trials of tazemetostat in NHL indications include a Phase I/II study evaluating tazemetostat in first-line DLBCL with the “R-CHOP” chemotherapy combination of rituximab, cyclophosphamide, doxorubicin hydrochloride (hydroxydaunomycin), vincristine sulfate (oncovin), and prednisone (NCT02889523); and a Phase I study in r/r DLBCL in combination with the Genentech (Roche) cancer immunotherapy Tecentriq (atezolizumab; NCT02220842).
Additionally, tazemetostat is in clinical trials that include a Phase II study as monotherapy in adults with INI1-negative tumors or r/r synovial sarcoma (NCT02601950); a Phase II trial in mesothelioma (NCT02860286); a Phase I/II study in non-small-cell-lung cancer, in combination with Tecentriq (part of Genentech’s Morpheus umbrella study; NCT03337698), a Phase II study in recurrent ovarian, primary peritoneal, or endometrial cancer (NCT03348631), and a Phase II study in molecularly-targeted tumors (NCT03155620). The last two trials are being carried out by the NIH’s National Cancer Institute.
Possible Protocol Changes
In April, the FDA imposed its partial clinical hold on U.S.-based enrollment of new patients in clinical trials of tazemetostat after a patient in a Phase I pediatric study (NCT02601937) developed a secondary T-cell lymphoblastic lymphoma (T-LBL).
Epizyme said today it has since reviewed the single T-LBL case in detail, and completed a comprehensive assessment of tazemetostat safety data and clinical activity observed to date across clinical trials. The company said it has also convened a panel of external experts to review and validate the assessment, and will include the information in a formal response to regulators.
In addition, Epizyme said, it has obtained new consent from all patients in its clinical trials and updated its informed consent form based on the safety report that followed the lymphoma case.
“Epizyme plans to continue its engagement with the [FDA] in the weeks ahead and then finalize its response to regulatory authorities, including changes that may be proposed to study protocols,” the company stated. “Once the company has gained alignment with regulators in the U.S., France and Germany, it is anticipated that the partial clinical hold would be lifted and that enrollment activities would be allowed to proceed in those countries.”
The company cited the “potential impact” of the partial clinical hold, and its need to include more mature durability data, in delaying a planned New Drug Application (NDA) submission for tazemetostat for the treatment of patients with epithelioid sarcoma (ES).
In October, Epizyme plans to present updated data from part of NCT02601950 evaluating tazemetostat as a monotherapy for ES. A recent assessment of interim data from the full 62-patient ES cohort in the study showed an objective response rate that remained consistent with what was observed in the initial 31 enrolled patients. Enrollment in the trial was completed in July 2017. In addition, durability data from the cohort continue to mature.
DexCom price target raised to $125 from $112 at BMO Capital
BMO Capital analyst Joanne Wuensch raised her price target on DexCom to $125 and kept her Outperform rating, saying the company delivered on high expectations in Q2. The analyst cites underlying volume increases, the outperformance of G5 system, and the contribution of the FDA’s new iCGM classification following the approval of Tandem’s Basal IQ with G6. Wuensch adds that the slight contraction in gross margins was related to incremental manufacturing lines costs to meet the strong demand.
Exact Sciences thesis remains firmly intact, says Cowen
Cowen analyst Doug Schenkel lowered his price target on Exact Sciences following its slight Q2 miss, but he said his buy thesis remains firmly intact. He said the slight miss was due to a compliance issue and changes in salesforce initiatives, but the revenue target remains intact. Schenkel maintained his Outperform rating but lowered his price target to $65 from $85 on Exact Sciences shares.
Mylan may have negative read-through from Teva report, says Wells Fargo
Wells Fargo analyst David Maris highlighted some items in Teva’s (TEVA) Q2 earnings report and conference call that he believes may have a negative read-through for Mylan (MYL). For one, Teva management said they expect the North American generics environment to remain challenging. Additionally, Copaxone sales were relatively flat sequentially, which would be a negative for Mylan if expectations are for increased contribution from Mylan’s Copaxone generic in Q2. Mylan has a large pipeline of biosimilars and Teva mentioned it is building a facility for biosimilars in Germany, which indicates more competition, added Maris, who keeps a Market Perform rating on Mylan shares.
Sellers of short-term health plans upped by eased ObamaCare rules
- Health Insurance Innovations and eHealth shares were higher
- The Trump administration issued a final rule that makes it easier to enroll in short-term health insurance plans.
- Carriers will be able to make short-term plans renewable for up to 36 months.
Companies that sell short-term health plans got a boost Wednesday after the Trump administration issued a final rule that loosened restrictions on plans that don’t comply with the Affordable Care Act.
The new rule allows consumers to enroll in short-term coverage for up to 36 months, instead of just 3 months allowed under the ACA rules set up under former President Barack Obama, more commonly known as Obamacare.
Shares of the companies that sell the plans jumped after the rule was released.
Health Insurance Innovations shares rose more than 13 percent in early afternoon trading, while eHealth shares were up more than 5 percent.
Short-term plans, which were designed to provide temporary care for people in between jobs, often come with substantially lower monthly premiums than other forms of insurance but tend to offer less coverage. They generally don’t preexisting conditions or prescription drugs.
In an interview Wednesday with CNBC’s “Squawk Box,” Health and Human Services Secretary Alex Azar said the new rules could provide relief to part-time or contract workers or people in rural areas that can’t afford a traditional ACA plan.
“We believe in options,” Azar said. “This is instead giving many millions of Americans an additional option.”
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