Indication intelligence, analysis and sector perception

RegMed Investors’ (RMi) pre-open: tensions weigh on this market and it’s not all about trade

May 7, 2019 8:13am

Don’t get comfortable with yesterday’s upside, Tuesday’s seven (7) earnings’ releases

News: Vericel (VCEL) has entered into exclusive license and supply agreements with MediWound Ltd. (MDWD), a severe burn and wound management company and reported Q1 financial results

The 6 W’s: Who, what, where, when, why and what of it … the real question is who is going to report what?

Critical information ahead of “our” universe’s open! I provide intelligence and analysis for short and near-term investment.

Dow futures are DOWN -0.53% (-139 points), S&P futures are DOWN -0.55% (-16 points) and NASDAQ futures are DOWN -0.62% (-49 points)

U.S. stock index futures were lower on Tuesday morning, as market participants continued to monitor trade relations between the U.S. and China;

European stocks traded slightly lower, after it was confirmed Chinese Vice-Premier Liu He would attend trade talks in Washington;

Asia Pacific stocks are mixed amid renewed US-China trade uncertainty;

Data docket: job openings and labor turnover survey (JOLTs) due at 10 a.m. ET; and consumer credit numbers due at 3 p.m. ET.

Tuesday’s ETF indications in the pre-market:

The iShares Nasdaq Biotechnology (IBB) is NOT indicating;

The SPDR S&P Biotech ETF (XBI) is NOT indicating;

The Health Care Select Sector SPDR ETF (XLV) is NOT indicating;

The iShares Russell 2000 (IWM) is indicating a NEGATIVE -0.52% DOWNSIDE;

Henry’omics:

Dow futures indicate a decline at the open as futures on the S&P and NASDAQ were lower.

Yet, traders are optimistic that Beijing and Washington will reach a deal despite the latest escalation of tariffs, however continued uncertainty about the outcome of the talks continues to weigh on the markets.

Anyone who reads my posts knows that I am about making money, no matter what happens in the sector. Instead of trying to guess at what sector will do, I continue to do what I always do, and that means watching what the patterns and markets are telling me.

Get ready for the seven (7) Q1/19 results and their resulting share pricing influences!

From Monday’s closing bell post, “today’s market and sector description, a crumble and a comeback. After the open’s crash, life was breathed into the sector although volume was low and percentage upswings weak.”

Upside volume stats … a compelling comparison

Monday: 7 out of the 32 upside had higher than the 3 month average volume;
Last Friday: 3 out of the 37 upside had higher than the 3 month average volume;
Thursday: 2 out of the 17 upside had higher than the 3 month average volume;

Downside volume stats … lean

Monday: 2 out of the 8 downside had higher than the 3 month average volume
Last Friday: 2 out of the 4 downside had higher than the 3 month average volume;
Thursday: 5 out of the 23 downside had higher than the 3 month average volume;

Q2/19 so far:

In May, there were 2 negative and 2 positive closes;

In April, there has been 10 positive and 11 negative closes;

Companies in my headlights – It’s your decision; I provide an idea and context:

Tuesday’s Q1 reporting includes: Applied Genetic Technologies AGTC; Vericel (VCEL); Audentes Therapeutics (BOLD); Editas Medicine (EDIT); Fate Therapeutics (FATE), Voyager Therapeutics (VYGR) and Regenxbio (RGNX);

MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, has entered into exclusive license and supply agreements with Vericel Corporation (VCEL) to commercialize NexoBrid® in North America (NA). NexoBrid is a topically-administered biologic product that removes eschar in patients with deep partial and full-thickness thermal burns, which is approved in the European Union and other international markets. The pivotal U.S. P3 DETECT clinical study met its primary and all secondary endpoints, and the submission of the Biological License Application (BLA) to the U.S. FDA is planned for Q4/19. $17.5 M upfront, sales royalties and up to $132.5 million in potential milestones; leveraging VCEL’s commercial capabilities and presence in U.S. burn care market. Great news for VCEL but, cash dilutionary yet I’d watch ANY upside ride and then SELL into strength;

Vericel (NASDAQ:VCEL) is also scheduled to announce Q1 earnings results, before market open. Net loss of $2.8 million, or $0.07 per share, compared to $7.7 M, or $0.21 per share, in Q1/2018;
Non-GAAP adjusted EBITDA loss of $0.4 million compared to a loss of $2.6 million in the first quarter of 2018;
As of March 31, 2019, the company had $84.1 M in cash and short-term investments compared to $82.9 million as of December 31, 2018; and
Full year 2019 revenue guidance for MACI® and Epicel® was raised to $110 to $114 million compared to previous full year revenue guidance of $108 million to $112 million.
The consensus EPS Estimate was -$0.07 and the consensus Revenue Estimate is $22.51M (+24.8% Y/Y). Let’s see …

Opinions expressed are those of the author and are subject to change, and not intended to be a forecast of future events, a guarantee of future results, nor investment advice.

Whether information or intelligence is good, bad or somewhere in between; I put into context what is relevant and useful for investors. All investments are subject to risks. Investors should consider investment objectives.

Henry McCusker, the editor and publisher of RegMed Investors does not hold or have positions in securities referred to in this publication.

35 companies, 1 interpreter!

Insight, foresight and recommendation

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Editor and Publisher ... Henry McCusker enters his tenth (10th) year at RegMed Investors with past experience in sell-side analysis, buy-side management, corporate management and due diligence.

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Henry McCusker, the editor and publisher of RegMed Investors does not hold or have positions in securities referred to in this publication.