Hurricane Sandy ensured that this week's trading week would be a shortened one and all thoughts and prayers are with those suffering and still dealing with the aftermath of that terrible storm. Around us, however, the world is still moving forward; the politicians are still politicking, world economies are still slowing, and - most importantly to those following VFC's Stock House - our favorite (or not so favorite) stocks and stories are again trading along and moving forward.
Again, the bulk of our thoughts go to those who need the strength right now - in all of the world's flashpoints and flood zones - but here's a look at some of our much-watched stories right now...
Earnings: With focus being drawn away from the markets earlier this week during the two day trading stand-down, some of the company's we've been following have postponed releasing their quarterly earnings reports. Mannkind Corp (MNKD) has pushed to Thursday (from Monday) and Dendreon (DNDN) has rescheduled to Friday, vice Tuesday.
Mannkind just saw its stock hammered as the company went through another round of financing and dilution in order to fund the new trials necessary to bring Afrezza before the FDA again as a potential inhaled insulin product for diabetics. Afrezza had previously demonstrated success in Phase III trials, but the FDA required new trials in order to test Mannkind's next-generation inhaler. Investors watching the earnings report will be keyed more into timelines, updates and expectations for Afrezza than the monetary impact of the recent financing, since that's already on the table.
Dendreon, as noted earlier in the week, will be looking to convince investors that cost-cutting measures are having a positive impact on the bottom line, as is the announced expanded coverage by insurance companies for Provenge. Numbers supporting these events may not be wholly evident in the reported-quarter's numbers, but company could offer insights into trends seen during the month of October. Should Provenge regain traction and start inching higher towards the $100 million/quarter mark again, then a rebound could materialize. Having traded to the mid threes again, it looks like investors are sceptical.
Pfizer (PFE) also delayed its report until Thursday.
Healthcare, Biotech, Pharmaceutical:
Amarin Corporation (AMRN): Excitement and anticipation continues to build among this company's long-sided investors in regards to a potential buyout or major partnership, especially after the UK's Daily Mail issued a speculative report tying AstraZeneca to the rumor, but nothing has materialized to date and shares slipped this week, giving back most of the rumor-fueled gains of last week.
Amarin did, however, report the issuance of another patent for Vascepa, further strengthening the company's intellectual position, even as news of a final FDA decision for Vascepa's New Chemical Entity (NCE) is still forthcoming. The patent news had little impact on the share price, but this continues to be one of the more-watched stories in the sector right now, as many analysts still have price targets on the stock in the mid-twenty dollar range in anticipation of a buyout.
Each day that goes by without a public commercialization plan or NCE announcement will keep the more weak-stomached investors skittish, but the right news could easily push this stock towards twenty again. The downside would be a plan to 'go it alone' with Vascepa, then a trip to under ten is possible, although general consensus among analysts and media outlets see that as the outcome of lowest probability.
Sunshine Heart (SSH): Sunshine shares have also slipped a bit both this week and last and are back to trading for closer to six dollars than seven. A similar dip during mid-October proved to be an opportune trading point, as shares quickly approached seven dollars again before tailing off into the low sixes. With multiple catalysts still pending for the quarter, SSH could again be trading at attractive prices for those looking towards the future of the company's C-Pulse Heart Assist system, a device already approved in Europe that has thus far proven to not only halt the progression of heart failure in patients with Class III and ambulatory Class IV heart failure.
Still pending within the current quarter is the official start of a pivotal trial in the United States that - if successful - would support an approval submission with the FDA. Sunshine last month received FDA clearance for the C-Pulse in conjunction with this trial, another milestone met on the path to the start date. Additionally, it is expected that the company could see its first commercial sales as a result of the European approval within the current quarter, offering another potential catalyst as the US trial moves forward.
Funding is set through the mid-way point of the trial, while a large - still unidentified - strategic investor put three million dollars into Sunshine's latest round of financing and appointed a member to the board. Such moves hint at potential partnerships and/or buyouts.
Given the recent pullback, SSH could be back into trading or accumulation territory.
NeoStem, Inc. (NBS): With NeoStem positioning for an increase in exposure this month, it could be worth keeping an eye on this story with shares slipping lower over the past few trading days. According to a mid-week press release, NeoStem officials will be presenting at four notable conferences during the month of November, starting next Tuesday in Los Angeles at the American Heart Association - Scientific Sessions 2012. NeoStem's most advanced treatment candidate, AMR-001, is designed to repair damaged heart tissue following a heart attack and - as a result of the regenerative aspects of the treatment - to also prevent major cardiac events from re-occurring. Such a developing stem cell technology could be of high interest at the AHA conference.
AMR-001has already successfully completed Phase I trials and a Phase II trial - titled PreSERVE -is already underway with results expected to start rolling in during the latter half of 2013. In milestone news relating to this trial, NeoStem last month received approval from a data monitoring committee to continue moving forward with PreSERVE. Also of note, NeoStem announced last month data confirming the ability of its VSEL technology to assist in bone-growing. Both news items cement NeoStem's place in the stem cell space and have contributed to the company's market cap settling at just around the one hundred million level in market cap, after trading for a significantly lower cap earlier in the year.
These recent successes will certainly be on show this month with four pending presentations, meaning NBS could be in the spotlight again, following a recent dip.
Roundup: After some question as to whether or not the number would appear following Sandy, this week also offers us October's jobs report on Friday - the last major economic news before next week's election. It's still anyone's guess who wins this one, so any market reaction to the election likely wouldn't occur until Wednesday morning. The first post-Sandy trading day fared well on the heels her beating, as the DOW traded relatively flat, while oil dropped in light of decreased demand.
Much of the northeastern coastline is in shambles right now, but - as they say - we will prevail.
Thoughts to those who need them.
Disclosure: Long AMRN, SSH, DNDN.
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