@adamfeuerstein looks like $GALT owners dumping $30mm newly issued SEC Form 8K shares on market from "time to time" #shortstock— Bo Czernyk (@MDsearchlight) November 6, 2013On Oct. 25, Galectin announced an "At The Market" equity sales agreement through which the company's broker MLV & Co. will sell up to $30 million in stock. These ATM stock sales are opaque -- the timing of sales and the number of shares sold is known only by the company and its broker. Galectin is only obligated to disclose ATM sales in its quarterly SEC filings. Galectin's ATM was announced a week after the stock hit an all-time high of $12.45 per share. You could say the company is being smart and opportunistic, but the market tends to view the dilution and opacity of ATMs bearishly. At Thursday's close, the stock is down 28% from its high. Galectin shares are under added selling pressure because its largest shareholder, 10X Fund, has been exercising warrants.
@adamfeuerstein Well having seen the results and the stock price reaction, are you revising your opinion on KERX's outlook?— Johnny Chung (@jc4jax) November 6, 2013No. I still believe investors are significantly under-estimating the risks involved with Keryx Pharmaceuticals ( KERX). I'm not surprised to see Keryx shares higher following the release of the Zerenex pre-dialysis kidney disease data this week. Keryx today is where Amarin ( AMRN) was 18 months ago before reality set in and the stock blew up. The two companies are very similar. Keryx has weak intellectual property protection for Zerenex and isn't likely to receive the market exclusivity or patent term extensions it needs. These are important issues I wrote about last March and are still very much in play. Keryx CEO Ron Bentsur has shifted his position and now insists he can market Zerenex on its own. What this tells me is partners are scared off by the patent and market exclusivity issues. I told you, Keryx is Amarin redux. Did you know Keryx isn't alone developing an iron-based phosphate binder? Vifor Pharma, a unit of Galenica Group, has already submitted its own iron-based phosphate binder PA21 for FDA approval. The expected approval decision date is Dec. 1. PA21 was developed in partnership with Fresenius Medical Care, which controls about one-third of the kidney dialysis market. If PA21 is approved, Fresenius isn't likely to put its own iron-based phosphate binder on the shelf in favor of Zerenex. That leaves Keryx in the difficult position of negotiating with Davita ( DVA), the other large dialysis service provider without much leverage. Another interesting wrinkle: PA21 was designed specifically so the iron is not absorbed by the body, which means there is no effect on iron stores, hemoglobin or anemia. This is not a bug, but a feature of PA21. Keryx will have you believe dialysis providers are clamoring for Zerenex because its iron is absorbed by the body and therefore has positive effects on hemoglobin and anemia and reduces utilization of IV irons. Yet Fresenius chose PA21, even though Zerenex has been around forever. Lastly, there's this week's study results in which Keryx re-packages Zerenex for kidney disease patients not yet on dialysis.
@adamfeuerstein $NAVB,you were totally correct on poor sales & demand.I should have listened to you.What do you think about their pipeline?— Mark (@FUNKYBUNCH34) November 6, 2013Navidea Pharma ( NAVB) is in serious trouble when typically table-pounding Ladenburg analyst Kevin DeGeeter cuts his price target in half to $3.50 and writes the following: On 11/6/13, NAVB reported 3Q13 financial results in line with our forecast and disclosed Norgine BV as the European marketing partner for Lymphoseek. While we believe it is still too early to draw conclusions regarding the U.S. launch of Lymphoseek, we are lowering our PT on shares of NAVB from $7.50 to $3.00 based on concerns regarding the European growth model and NAVB's governance structure. Specifically, after an extended negotiation process we were disappointed by the selection Norgine as the European partner for Lymphoseek. While we view Europe as a significantly smaller market opportunity we are concerned Norgine, which does not have any prior experience selling to radiology departments, does not have adequate commercial presence to drive optimal reimbursement and distribution of Lymphoseek. As such, we are cutting our peak gross EU sales forecast from $35M to $12M. Additionally, we, and other investors, in our view, continue to struggle with the terms and structure of NAVB's September $30M financing. Given that NAVB already had a single large shareholder with the potential to exert significant influence over corporate governance, we question the wisdom of placing $30M with a single (new) institutional investor and further accentuating shareholder concentration. Lymphoseek revenue in the September quarter was a miniscule $144,000. As I explained more than a year ago, this product is not going to perform well commercially. Navidea's pipeline offers nothing of value and its balance sheet/shareholder structure are a mess. Navidea is trading at a three-year low. Greg F. writes: I saw your article on Cytori Therapeutics (CYTX). The biggest problem with Cytori is their technology sucks. It has small capacity, low yields, FDA concerns and it is old technology. They spent over $400 million developing a technology that doesn't work and will not be FDA approved. Tell that to the shareholders. It looks to me like they found a buyer that was sold a lot of hype. Regardless of his experience in the stem cell field, it's going to fail simply because the technology is terrible. Agreed. I've long maintained Cytori's biggest problem is that the stem cell "soup" spun out of its belly-fat liposuction machines isn't an effective therapy for anything. This is why Cytori is shut out doing business in the U.S. -- FDA won't approve its stem-cell processing device because the company hasn't run clinical trials demonstrating patients benefit from the stem cells. Cytori seems to be migrating to Asia now where regulatory standards are more lax. -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein