RegMed Investors’ (RMi) closing bell; a welcomed upside for the oversold

May 4, 2018 5:29pm

The sector cruised as tailwinds proffered

A couple of “beats’ to consensus and expectation lifted the cloud cover yet, the “ups” were off the mid-day highs

Validating there is continuous profiteering in this market and it’s not over

Pre-open indications: 4 HIT and 4 MISS

Q1/18 “earnings”: Ionis Pharmaceuticals (IONS) and Alnylam Pharmaceuticals (ALNY)

End of day briefing; the “numbers” speak; if you know what happened today, you’ll understand what you need to do Monday!

Henry’omics:

Today’s moves … the oversold were recognized but, will it be sustained?

So I don’t dwell on “good” moves of the session, I have marinated blue cheese stuffed olives in a shaken distilled potatoes’ based beverage to celebrate the week’s end – remember it’s all about the vegetables and TGIF!

Some sector “names” stocks kept the lights on:  BLUE (after yesterday’s slip), ALNY (after Wednesday and Thursday’s slip), BMRN, SLDB (again) and IONS (after Thursday’s slip)

While losers hid in the open – ADVM, VCEL, NTLA, VSTM and ONCE

The advance/decline line scenario of 45 covered companies:   

• The open started positive with an ADL of 23/15 and 7 flats;
• The mid-day stayed positive with an A/DL of 30/11 and 4 flats
• The close concluded positive with an A/DL of 34/8 and 3 flat;

From Friday’s pre-open newsletter, “… mind over matters at hand. TGIF although the masking of today’s indicators is an issue! Key nonfarm-payrolls data ahead, focus on the signals not the noise.”

As I also stated, “What’s missing from the sector is something to make investors jump through the usual hoops – low volume, volatility and sentiment’s depression! I also don’t see pronounced catalysts, and if weak earnings reports aren’t enough, what pushes us away from the SELL button – losses but is there a reason to push the BUY button to even consider doubling down for a … perceived upside?”

Pre-open indications: 4 hit and 4 miss

• Editas Medicine (EDIT) closed +$1.40 – hit;
• Aduro Biotech (ADRO) closed up +$0.15 – miss;
• Alnylam Pharmaceuticals (ALNY) closed up +$4.04 – hit;
• CRISPR Therapeutics (CRSP) closed up +$1.32 – miss;
• Ions Pharma (IONS) closed up +$2.74 – hit;
• Sage Therapeutics (SAGE) closed up +$0.25 – miss;
• uniQure (QURE) closed down -$0.18 – hit;
• Verastem Oncology (VSTM) closed down -$0.05 – miss;

MY working five (5) trend lines:

… The greatest volume to the downside:  ADVM, XON, VCEL, NTLA and VSTM

… Upside volume was weighted to:  ALNY, IONS, EDIT, SGMO and BMRN

… Biggest $ downside:  ADVM (-$1.025), ONCE (-$0.82), VCEL (-$0.35), NTLA (-$0.30) and QURE (-$0.18)

… Best moves to the $ upside:  BLUE (+$4.50), ALNY (+$4.04), BMRN (+$3.08), SLDB (+$2.77) and IONS (+$2.74)

… Flats: BSTG, AST and ONVO

Q1/18 financial results i.e. earning – the LPS (loss-per-share) skirmish:

Ionis Pharma (IONS)…

Platform Development:

• Expanded strategic research collaboration with Biogen (BIIB) for neurological diseases invested in TEGSEDI™ commercialization through Akcea
• SPINRAZA ® for SMA – one of the most successful orphan disease drug launches in history
• TEGSEDI (inotersen) for hereditary transthyretin amyloidosis (hATTR) – potential to transform the lives of people with hATTR; on-track to launch in 2018
• WAYLIVRA (volanesorsen) for FCS and FPL – potential first treatment for people with FCS; global on-track to launch in 2018
• Collaboration with AstraZeneca for Cardiovascular, Renal and Metabolic Diseases

The “numbers”:

Ionis reported a net loss of $10.8 million forQ1/18, compared to net income of $9 million for Q1/17, all according to GAAP. On a pro forma basis, Ionis reported net income of $17.6 million forQ1/18, compared to net income of $29.9 million for the Q1/17. Ionis' GAAP net loss increased and its pro forma net income decreased in the Q1/18 primarily due to increased operating expenses as Ionis prepares to commercialize TEGSEDI and WAYLIVRA.

• Total revenues increased by 25%, driven by SPINRAZA royalties
• Revenues increased by 25%, driven by SPINRAZA royalties
• GAAP operating and net loss near breakeven; on track for 3^rd consecutive year of pro forma operating profitability

Cash will increase to more than $2 billion, combining Ionis' Q1 cash balance of more than $1 billion with $1 billion expected upon closing of IONS' expanded collaboration with BIIB

IONS closed up +$2.75

Alnylam Pharmaceuticals, Inc. (ALNY) …

Platform development:

• Advanced patisiran, an investigational RNAi therapeutic for the treatment of patients with hereditary ATTR amyloidosis,
• Received acceptance from the FDA and the European Medicines Agency (EMA) of patisiran’s New Drug Application (NDA) and Marketing Authorization Application (MAA),
• Advanced ALN-TTRsc02, a subcutaneously administered investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis, with updated data from the P1 study presented at ISA, and receipt of a positive opinion from the EMA Committee for Orphan Medicinal Products (COMP) in the EU for ALN-TTRsc02 for the treatment of ATTR amyloidosis,
• Advanced givosiran, an investigational RNAi therapeutic in development for the treatment of acute hepatic porphyrias (AHPs),
• Presented new positive P1 and P1/2 open-label extension (OLE) study results at the European Association for the Study of the Liver (EASL) meeting,
• Completed enrollment of the first 30 patients in the ENVISION P3 study, which comprise the interim analysis cohort for a potential accelerated approval by the FDA,
• With partner Sanofi, advanced fitusiran – an investigational RNAi therapeutic in development for the treatment of hemophilia A and B with or without inhibitors – with the initiation of dosing in the ATLAS Phase 3 program,
• Announced plans to collaborate with Regeneron to identify RNAi therapeutics targeting the genetically validated target HSD17B13 for nonalcoholic steatohepatitis (NASH) and potentially other related diseases,
• Announced a settlement of all pending litigation with Dicerna, in which DRNA agreed to pay $25 million in cash and equity to ALNY and also agreed to restrictions on its development and other activities relating to oligonucleotide-based therapeutics directed toward certain Alnylam targets, for periods ranging from eighteen months up to four years.

Presented new data from the APOLLO P3 study, including:

• Data at the International Symposium on Amyloidosis (ISA), including results on the effects of patisiran on cardiomyopathy manifestations; and,
• New data from a post-hoc analysis presented at the American Academy of Neurology (AAN) meeting on the effects of patisiran on the composite rate of all-cause hospitalization and mortality.

The “numbers”

ALNY reported a loss of $141.2 million or -$1.41 per share,

• Revenues were $21.9 million in Q1/18, as compared to $19 million in Q1/17.

ALNY had cash, cash equivalents and fixed income marketable securities, and restricted investments of $1.568 billion, as compared to $1.73 billion at 12/31/17.

ALNY closed up +$4.04

Daily analytics:

U.S. stocks rose sharply Friday as shrugging off lackluster numbers in the government's monthly jobs report

• The Dow rose 332.4 points or +1.39% to 24,262.57 having dropped more than 150 points shortly after the opening bell,
• The S&P 500 rose 33.69 points or +1.28%after having fallen 0.4% earlier in the day.
• The NASDAQ rose 121.47 or +1.18% to 76.09

The CBOE Volatility Index (VIX) widely considered the best gauge of fear in the market,

• Friday traded at 14.77, down -7.11 %
• Thursday traded at 15.90 , down -0.44% …
• Wednesday traded at 15.97, up +3.10 %
• Tuesday traded at 15.49, down -2.76%
• Monday traded at 16.05, up +4.15%
• Last Friday traded at 15.41 ,down -5.11 %

The iShares Russell 2000 (IWM) indicated:

• Friday was up +1.22%
• Thursday -0.55%
• Wednesday +0.36%
• Tuesday +0.46%
• Monday -0.90%
• Last Friday -0.14%

The iShares NASDAQ Biotechnology (IBB) indication:

• Friday was up +1.06%
• Thursday -1.36%
• Wednesday -1.32%
• Tuesday +0.39%
• Monday -1.86%
• Last Friday +0.29%

The count in May - decliners versus gainers:

……. look at the differences in decliners:

• Friday’s decliners ranged from -0.28% <XON -$0.05 > to -16.14% <ADVM -$1.025 > in 8 equities;
• Thursday’s decliners ranged from -0.08% <BMRN -$0.07> to -4.97% <SGMO -$0.85 > in 29 equities;
• Wednesday’s decliners ranged from -0.11% <XON -$0.02 > to -4.40% < BMRN -$3.79> in 15 equities;
• Tuesday’s decliners ranged from -0.75% <VCEL -$0.10> to -17.33% <RENE.L> in 15 equities;

Versus

… Look at the percentage’s (%) and spreads …

• Friday’s gainers ranged from +0.17% <SAGE +$0.25 > to +17.20% <SLDB +$2.77 > in 34 equities;
• Thursday’s gainers ranged from +0.45% <BTX +$0.01 > to +8% <AST +$0.10 > in 11 equities;
• Wednesday’s gainers ranged from +0.26% <IONS +$0.11 > to +5.66% <SLDB +$0.83 > in 22 equities;
• Tuesday’s gainers ranged from +0.45% <FIXX +0.09> to +5.30% <PSTI +$0.07> in 25 equities;

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.