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Monday, January 13, 2020

OrthoPediatrics updates guidance

OrthoPediatrics Corp. (NASDAQ:KIDS) reports Q4 revenue is anticipated to be $19M on a preliminary basis. The tally is up 30% from a year ago.
For the full year, OrthoPediatrics’ revenue is expected to be up 26% to $72.6M.
The company plans to release full results in early March.
Source: Press Release
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Verona Pharma up 59% premarket on positive ensifentrine data

Thinly traded nano cap Verona Pharma (NASDAQ:VRNA) is up 59% premarket on modest volume in reaction to positive results from a Phase 2b clinical trial evaluating lead drug ensifentrine or placebo as an add-on treatment to tiotropium (Boehringer Ingelheim’s Spiriva Respimat) for the treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD).
The study met the primary endpoint of improved lung function as measured by the improvement in peak forced expiratory volume in one second (FEV1) at week 4 in patients receiving ensifentrine added on to tiotropium compared to placebo added on to tiotropium. The primary objective was achieved at all doses tested.
The results support dose selection for Phase 3 studies.
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Lilly’s Tyvyt + Alimta successful in lung cancer study

Eli Lilly (NYSE:LLY) announces positive results from a China-based Phase 3 clinical trial, ORIENT-11, evaluating the combination of Tyvyt (sintilimab injection), Alimta (pemetrexed) and platinum-based chemo for the first-line treatment of advanced/recurrent nonsquamous non-small cell lung cancer (nsqNSCLC), without sensitive EGFR mutation or ALK rearrangement.
The study met the primary endpoint of progression-free survival based on an interim analysis by the Independent Data Monitoring Committee.
No new safety signals were observed.
The trial is being conducted by sentilimab development partner Innovent Biologics. A marketing application in China is next up.
Additional data will be presented at an upcoming medical conference.
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Lannett +15% premarket on NDA approval of Numbrino

The FDA has approved Lannett’s (NYSE:LCI) New Drug Application (NDA) for Cocaine Hydrochloride (HCl) Nasal Solution 4% (40 mg/mL), the company’s branded local anesthetic product.
Product launch is expected shortly under the brand name NUMBRINO.
NUMBRINO is indicated for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.
Shares are up 15% premarket.
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Emergent Biosolutions reports prelim 2019 results and FY20 guidance

Emergent BioSolutions (NYSE:EBS) reports FY19 prelim revenue in the range of $1.1B-$1.5B against prior guidance of $1.06B-$1.14B, consensus estimate of $1.1B.
FY19 gross margin in the range of 56-58% up 200-400 bps from prior year.
FY19 net income in the range of $53M-$63M down from prior guidance of $80M-$110M.
FY19 adj. net income in the range of $150M-$160M.
FY19 adj. EBITDA in the range of $280M-$290M.
FY20 revenue in the range of $1.18B-$1.28B; adj. net income $160M-$210M; and adj. EBITDA of $300M-$360M.
#JPM20
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Organogenesis Holdings reports preliminary Q4 revenue results

Organogenesis Holdings (NASDAQ:ORGO) says it expects Q4 Net revenue to be between $72.6M to $74.6M (+14% to +17% Y/Y) vs. consensus of $70.39M, comprising of Advanced Wound Care products revenue growth of 14% to 16%; Surgical & Sports Medicine products revenue growth of 18% to 24%; PuraPly products growth of 37% to 40% and non-PuraPly commercially available products revenue growth of 14% to 18%.
For FY2019 Net revenue is expected to be in the range of $258.9M to $260.9M (+34% to +35% Y/Y), vs. consensus of $256.75M.
#JPM20
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Seeking Alpha’s JPMorgan Healthcare Conference coverage

The 38th Annual JPMorgan Healthcare Conference is underway, with plenty of deals, abstracts, test results, and operational updates.
Our news coverage of #JPM20 is here.
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