The Daily Biotech Pulse: Gilead Earnings, Codexis Sings Pact With Merck, Eli Lilly Reports Positive Trial Results

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 Feb. 4)

• AEterna Zentaris Inc. AEZS
• Axsome Therapeutics Inc AXSM
• BioSpecifics Technologies Corp. BSTC
• Dr.Reddy's Laboratories Ltd RDY(reacted to Dec. quarter results)
• Eli Lilly And Co LLY
• Medpace Holdings Inc MEDP
• Osiris Therapeutics, Inc. OSIR
• Veracyte Inc VCYT
• XBiotech Inc XBIT

Down In The Dumps

(Biotech stocks hitting 52-week lows on Feb. 4)

• Leap Therapeutics Inc LPTX

Stock In Focus

Gilead Q4 EPS Misses Estimate

Gilead Sciences, Inc. GILD reported a year-over-year decline in fourth-quarter revenues from $5.9 billion to $5.8 billion, weighed down by a decline in Hepatitis C virus product sales. Non-GAAP net oncome per share also fell from $1.44 to $1.78. Analysts, on average, estimated EPS of $1.71 on revenues of $5.49 billion.

For 2019, Gilead guided to product sales of $21.30 billion to $21.80 billion and product gross margin of 85-87 percent.

Separately, the company announced an 11-percent increase in its quarterly cash dividend to 63 cents, beginning in the first quarter.

The stock fell 3.64 percent to $67.50 in after-hours trading.

Codexis Sings Agreement For Upgrades to Platform Installed at Merck

Codexis, Inc. CDXS, a protein engineering company, announced the signing of an agreement with Merck & Co., Inc. MRK, under which the former will install certain CodeEvolver protein technology upgrades into Merck's platform license installation. Codexis will also maintain the upgrades for a multi-year term.

The companies did not divulge the financial terms of the deal.

Codexis had signed a CodeEvolver platform technology license agreement with Merck in 2015 for granting Merck a non-exclusive license to use the technology to develop novel enzymes for use in the manufacture of pharmaceutical products.

The stock rallied 10.08 percent to $21.51 in after-hours trading.

See Also: Attention Biotech Investors: Mark Your Calendar For These February PDUFA Dates

Opko Health Announces Debt Offering Worth $200M

Opko Health Inc. OPK intends to offer $200 million agreement principal amount of convertible senior notes due 2025 in an underwritten public offering. The company said it intends to use the net proceeds to fund R&D to further, develop and commercialize its portfolio of proprietary pharmaceutical and diagnostic products, among other things.

The stock slumped 14.20 percent to $3.02 in after-hours trading.

BiolineRX To Offer ADS & Warrants

BIOLINERX LTD/S ADR BLRX has commenced an underwritten public offering of ADS, each representing one of its ordinary share, with each ADS to be sold in a fixed combination with a warrant to purchase ADSs. All the securities earmarked for the offering are to be sold by the company. The company said it intends to use the net proceeds for general corporate purposes, including working capital and funding clinical trials.

The stock plummeted 19.63 percent to 59 cents in after-hours trading.

Eli Lilly's Eczema Drug Meets Primary Endpoint In Late-stage Trials

Eli Lilly said baricitinib, which it is evaluating in two Phase 3 studies dubbed BREEZE-AD1 and BREEZE-AD2 for adult patients with moderate to severe atopic dermatitis met the primary endpoint at Week 16 defined by the Investigator's Global Assessment for AD score of clear or almost clear.

"These are two of five studies that will be part of the placebo-controlled data program intended to support global registration," the company said.

Lilly also said it will present the full data results from both the BREEZE-AD1 and BREEZE-AD2 studies at future scientific venues and in peer-reviewed journals.

Sanofi Reports Positive Trial Results For Blood Cancer Drug

Sanofi SA SNY said a Phase 2 trial that evaluated its Isatuximab for treating patients with relapsed/refractory multiple myeloma met the primary endpoint of prolonging progression free survival.

"We look forward to engaging with regulatory authorities with the goal of bringing this potential new treatment to patients as quickly as possible," said John Reed, Head of Research and Development at Sanofi.

Roche Makes Regulatory Submission For Expanded Indication For Kadcyla

Roche Holdings AG Basel ADR RHHBY said it has submitted sBLA for its Kadcyla for adjuvant treatment of people with HER-2 positive early breast cancer with residual disease after neoadjuvant treatment, The drug has a Breakthrough Therapy Designation for the indication. Roche has licensed technology for Kadcyla from ImmunoGen, Inc. IMGN.

Kadcyla was approved in 2013 for treating HER-2 positive late-stage breast cancer.

On The Radar

Earnings

Array Biopharma Inc ARRY
BIO-TECHNE Corp TECH Q2 Adj. EPS $1.06 Beats $0.98 Estimate, Sales $174.5M Beat $170.19M Estimate
Neurocrine Biosciences, Inc. NBIX (after the close)