Overreaction to FDA - Dynavax' HBV Decision

The Vaccines and Related Biological Products board voted its confidence in the immunogenicity of Dynavax's (DVAX-$2.44) Heplisav by a 13 – 1 vote; however, the committee said in an 8 – 5 decision, with one abstention, that it could not recommend the vaccine for approval to the FDA due to insufficient clinical safety data, especially in certain minority groups.

To ask Dynavax – or any company -- to power the study design specifically tailored to those at minority groups at higher-risk would be cost prohibitive. The biotech has spent more than $300 million (in just the last five years) to move the drug through the pipeline approval process.

If a larger cohort represented by a more diverse ethnic sampling is necessary, how come an under-represented enrollment of blacks (about nine-percent) was sufficient when the FDA positively reviewed GlaxoSmithKline’s (GSK) other adjuvant vaccines, like the Hep-A drug Havrix and the combination DTP-HBV vaccine Infanrix?

Continue Reading at YCharts: Dynavax: Little Stock With a Big Story – Plunge a Buy Opportunity?

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.

Priceline Paddles Upstream with Kayak Software

Though Kayak Software (KYAK-$39.68) is looking to move beyond the meta-search business, its business model is tethered to the “hunt.” In fact, the loss of any airline ticket search business would prove material to Kayak. The company derives 25% of sales from airfare searches. Moreover, management has previously stated in regulatory filings that “a significant number of travelers who use (our) websites and mobile applications for non-air travel services” come to Kayak first to conduct queries on airline ticket pricing information.

 

Continue reading at YCharts: Priceline’s Kayak Deal Has Competitive Pitfalls, But Here’s Why It Makes Sense, Anyway

 

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.

Carl Icahn - Netflix 'Tomb Raider' or Savior?

Unlike past proxy battles, Icahn’s $168.9 million invested in Netflix (NFLX-$79.60) is a highly leveraged bet. He controls his stake principally through in-the-money call options: Of 4.7 million shares “bought” in the past 60 days, almost 4.3 million (90%) were two-year call options (at $36.05 a share) purchased at premiums ranging from $18.94 to $24.78 per contract, which expire on September 4, 2014.

If Icahn is serious about turning Netflix’s performance around, he’ll have to spend millions more to convert his “beneficially”-owned stake into actual ownership.

Continue reading at YCharts: Carl’s Icahn’s Netflix Position Made of Cheapy Options: a Not-So-Serious Man

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.

Monster Beverage's Stock Needs Caffeine Jolt

Although Monster Beverage’s (MNST-$45.50) net sales in the second quarter grew by 28.2% to $592.6 million, gross profit fell 100 basis points to 51.8% due to a 31.9% increase in promotional allowances. Given the frenzied elbowing for domestic share, gross margins at Monster in coming quarters will likely decelerate further.

Although management will deny it, recent adverse publicity due to the Food and Drug Administration launching an investigation into five deaths allegedly tied to Monster Energy drinks means the company will need to improve its “public image.” Ergo, to get in front of a public debate whose aim would be to restrict sales of energy drinks to minors and/or regulate caffeinated-energy drinks, look for Monster to increase the budgets for two line items that fall under operating expenses: merchandise displays and direct/advertising – pressuring net operating margins well into next year.

Continue reading at YCharts: Monster Beverage Stock: There are Problems Beyond the Recent Health Scare

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.