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Tuesday, January 21, 2020

Adaptive Biotech sees a 52% jump in 2019 revenue; shares up 4% after hours

On a preliminary basis, Adaptive Biotechnologies (NASDAQ:ADPT) expects 2019 revenues to be $84M – 85M, up ~52% at the midpoint and slightly above consensus of ~$83M.
Final Q4 and 2019 results will be released in late February.
Shares up 4% after hours.

Cutera adds to preliminary results-stoked sell-off

Thinly traded micro cap Cutera (CUTR -8.1%) is down on over 70% higher volume, a modest 280K shares, after it announced preliminary Q4 and 2019 results on January 12. The stock has slumped 15% since then.
A Stephens report that several sales executives have departed, including for EVP of Sales North American Larry Laber, has added to the bearishness.

Merck sues Teva to block entry of generic Dificid

Merck (MRK -1.1%) has filed patent infringement litigation in New Jersey against Teva Pharmaceutical Industries (TEVA -1.6%) in a move to block the market entry of the latter’s generic version of antibiotic Dificid (fidaxomicin).
Merck claims that Teva’s candidate infringes on five Dificid patents, one expiring in January 2024 and four in January 2028. It sued Teva in 2015 over the same patents (case still pending).

Genprex soars on accelerated review status for Oncoprex in lung cancer

Nano cap Genprex (GNPX +308.3%) rallies on a healthy 45x surge in volume in reaction to Fast Track status in the U.S. for immunogene therapy Oncoprex, combined with AstraZeneca’s Tagrisso (osimertinib), for the treatment of patients with EGFR mutation-positive non-small cell lung cancer (NSCLC) who have progressed on osimertinib alone.
A Phase 1/2 study is next up.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
Oncoprex consists of the TUSC2 gene complexed with a lipid nanoparticle.

Arrowhead dives on bearish start of RNAi coverage

Shares of Arrowhead Pharmaceuticals (ARWR) crashed to a two-month low Tuesday after an analyst initiated overage of ARWR stock with an underperform rating.
SVB Leerink analyst Mani Foroohar expects competitive headwinds to batter ARWR stock over the next year. Further, Big Pharma rivals are likely to launch cardiovascular and lipid drugs with massive sales forces before Arrowhead reaches the market, he said.
“We see the next 12 months as far more challenging than the past two years as Arrowhead faces sky-high expectations in the face of increasingly clear competitive headwinds,” he said in a note to clients. Foroohar initiated coverage with an ARWR stock price target of 32.
In morning trading on the stock market today, ARWR stock tumbled 13.3%, near 48.90, in moderate volume.
Arrowhead is working on a technology that interferes in ribonucleic acid, or RNA. RNA acts as a messenger, carrying instructions from the DNA that control protein creation. The technology is often called RNAi.
Arrowhead’s lead drug is called ARO-AAT. If approved, it would treat alpha-1 antitrypsin deficiency, a genetic condition that can cause lung and liver problems. It’s important to note that Arrowhead’s drug is the furthest along among RNAi-focused companies.
But Foroohar sees ARWR stock challenged by the likes of Vertex Pharmaceuticals (VRTX). Vertex is further behind Arrowhead in developing a treatment for alpha-1 antitrypsin deficiency. But Vertex’s drug could improve liver and lung disease “with the convenience of a pill,” he said.
“An update on the first of several Vertex (drugs called) correctors is expected in 2020 and represents a major risk catalyst to our — and Street — ARO-AAT estimates,” he said.

Rivaling Big Pharma In Cardio Diseases

A number of assets in Arrowhead’s pipeline focus on cardiovascular and lipid disorders. But the biotech company is far from the only player in this space.
Arrowhead’s targets are genetically validated. But the biotech company is going up against larger Big Pharma stalwarts in these disorders, Foroohar said.
This suggests “the orphan pricing necessary for Arrowhead to capture value from these assets may not be realizable, as launching these drugs against lower-priced competitors with broad labels, robust datasets and sizable sales forces is outside Arrowhead’s core competency,” he said.

ARWR Stock Benefits From RNAi Deal

Further, ARWR stock benefits from an RNAi partnership with Johnson & Johnson (JNJ) in hepatitis B. But even that can’t save ARWR stock, Foroohar said. He also noted investors have baked a substantial acquisition premium into shares.
“A partnering transaction for key Arrowhead pipeline assets or strong data from Vertex in alpha-1 antitrypsin deficiency or competitors in cardio-metabolic programs could flatten this premium,” Foroohar said.

Speculation drives virus-related names higher

Alpha Pro Tech (APT +37.3%), iBio (IBIO +20.5%) and Lakeland Industries (LAKE +33%) spike after the CDC says a traveler from China carried the coronavirus to Seattle.
There is some speculative buying action on the companies potentially seeing a sales increase from their products on health concerns.

FDA OKs Horizon’s teprotumumab for thyroid eye disease

The FDA approves Horizon Therapeutics’ (HZNP -0.4%) Tepezza (teprotumumab-trbw) for the treatment of thyroid eye disease, an Orphan Drug, Priority Review, Fast Track and Breakthrough Therapy indication. The agency’s action date was March 8.
The company will conduct a post-marketing study to assess safety in a larger patient population.
Commercial launch will begin shortly.
Horizon expects to pay ~$105M in milestones in H1. It secured the rights to teprotumumab in 2017 via its $145M acquisition of River Vision Development Corp.