The Daily Biotech Pulse: Hologic, Celgene Earnings, FDA To Rule On Alkermes Depression Drug

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech stocks hitting 52-week highs on Jan. 30)

• Varian Medical Systems, Inc. VAR
• EXACT Sciences Corporation EXAS

Down In The Dumps

(Biotech stocks hitting 52-week lows on Jan. 30)

• Oramed Pharmaceuticals, Inc. ORMP

Stock In Focus

Hologic Q1 Results Beat Estimates

Hologic, Inc. HOLX reported Q12019 non-GAAP EPS of 58 cents per share on revenues of $830.7 million, up 5 percent year-over-year. The results exceeded the consensus estimates, which called for EPS of 57 cents per share on revenues of $817.94 million. The company raised its full-year constant currency revenue and EPS guidance.

Roche Reports Strong FY18 Results

Roche Holdings AG Basel ADR Common Stock RHHBY reported 7 percent increase in FY2018 sales and net income rose 24 percent, exceeding estimates of most analyst. The company forecast low- to mid-single digit sales growth for FY2019.

Surmodics Q1 Results Exceed Estimates

SurModics, Inc. SRDX reported Q1 2019 non-GAAP EPS of 12 cents Vs. 10 cents a year ago, on revenues of $22.2 million, up 31 percent year-over-year. The results were ahead of expectations. The company raised the low end of its FY19 revenue guidance from $94 million to $97 million. The company also narrowed its non-GAAP bottom line guidance to earnings of 2-22 per share. Analysts, on average, estimate EPS of 7 cents per share on revenues of $93.76 billion.

On The Radar

PDUFA Date

Alkermes Plc ALKS awaits FDA decision on its NDA for ALKS 5461, which is being evaluated as an adjunctive treatment for major depressive disorder, or MDD, with an inadequate response to standard antidepressant therapies. FDA's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, which met jointly to discuss the NDA Nov. 1, voted 2-21 against approval of the drug, citing the inadequate benefit-risk profile.

Earnings

Celgene Corporation CELG Q4 EPS $2.39 Beats $2.32 Estimate, Sales $4.037B Beat $3.98B Estimate

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