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Friday, August 9, 2019

Epizyme EPS misses by $0.01

Epizyme (NASDAQ:EPZM): Q2 GAAP EPS of -$0.53 misses by $0.01.
Revenue of $5.9M (-50.8% Y/Y)

Hikma Pharmaceuticals reports 1H results

Hikma Pharmaceuticals (OTCPK:HKMPF): 1H Non-GAAP EPS of $0.72; GAAP EPS of $0.76.
Revenue of $1.05B (+7.3% Y/Y)

CASI Pharmaceuticals EPS misses by $0.07

CASI Pharmaceuticals (NASDAQ:CASI): Q2 GAAP EPS of -$0.16 misses by $0.07.
cash and equivalents of $70.3M

Diplomat Pharmacy EPS misses by $1.94, beats on revenue

Diplomat Pharmacy (NYSE:DPLO): Q2 GAAP EPS of -$2.13 misses by $1.94.
Revenue of $1.29B (-9.2% Y/Y) beats by $60M.
Shares +5.26% PM.

Analyst action premarket, Aug. 9

Addus HomeCare (NASDAQ:ADUS) initiated with Outperform rating at William Blair.
Denali Therapeutics (NASDAQ:DNLI) initiated with Buy rating and $30 (57% upside) price target at BTIG Research.
Cronos Group (NASDAQ:CRON) upgraded to Buy with a C$22 (20% upside) price target at PI Financial. Upgraded to Hold with a C$17 price target at Canaccord.
Avedro (NASDAQ:AVDR) downgraded to Market Perform with a $27 (16% upside) price target at Cowen and Company.
Corindus Vascular Robotics (NYSEMKT:CVRS) downgraded to Market Perform with a $4.28 (flat) price target at Cowen. Shares down 1% premarket.
Nektar Therapeutics (NASDAQ:NKTR) downgraded to Hold with a $23 (22% downside risk) price target at Jefferies. Downgraded to Neutral with a $33 price target at JPMorgan. Downgraded to Neutral at Mizuho Securities. Shares down 30% premarket on concerns of diminishing patient responses to NKTR-214 (bempegaldesleukin).
Wright Medical Group (NASDAQ:WMGI) downgraded to Neutral with a $25 (14% upside) price target at BofA Merrill Lynch. Shares down 5% premarket after Q2 miss and guidance cut.

Bayer: $8B to settle Roundup claims

Bloomberg reports that Bayer (OTCPK:BAYRY) is proposing to pay $8B to settle more than 18,000 Roundup cancer claims, although plaintiffs’ attorneys want more than $10B. Any deal could take months to work out.
Shares are up 4% in Europe.

Nektar down 33% premarket on NKTR-214 quality control issue

In the earnings call yesterday after the close, Nektar Therapeutics (NASDAQ:NKTR) President & CEO Howard Robin mentioned a “softening in response rates” in the Phase 1/2 PIVOT-02 study evaluating NKTR-214 (bempegaldesleukin), combined with Bristol-Myers Squibb’s (NYSE:BMY) Opdivo (nivolumab) or Opdivo + Yervoy (ipilimumab) between the first and second Fleming cohorts in melanoma (the issue was first raised at ASCO in early June).
Apparently two of the earliest production batches of product were different than the other 20 batches produced. Specifically, there was a single “suboptimal” batch of in-process intermediate that was used to produce the two lots, most of which were used in the study. All subsequent product has been produced within specifications.
To address the issue, the company has developed a “comprehensive control strategy” to limit variances in raw materials, intermediates and final product that is currently being validated for commercial-scale manufacturing. It has also revamped the structure of its CMC organization with supply chain and manufacturing now reporting to SVP of Manufacturing Kevin Brodbeck, Ph.D. Biologics Process Sciences is now reporting to Chief Scientific Officer Jonathan Zalevsky, Ph.D.
Shares down 33% premarket on modestly higher volume.