GW pharma partner Almirall hints at Sativex approval timing of Q1 2010

From pipelinereview.com (February 25th 2010):


Following publication of Spanish company Almirall's 2009 results today:


"The regulatory filing of Sativex® for the treatment of spasticity due to multiple sclerosis was submitted in UK and Spain under the European decentralised procedure, following the announcement of positive results in a phase III study where Sativex® showed relevant improvement in spasticity in multiple sclerosis patients. It is expected that the outcome of the regulatory submission will be known during the first quarter of 2010. Following potential approval in the UK and Spain, submissions for approval would be made in other European countries during 2010 under the mutual recognition procedure. Development of Sativex® for oncological pain in ongoing with results from an ongoing phase II/III study expected mid 2010."


"Silodosin (a licensed product from Recordati for use in the treatment of benign prostatic hyperplasia) was recently approved by the European Comission and we expect the regulatory outcome from Sativex® (used in the treatment of spasticity in multiple sclerosis) during this first quarter of 2010. Pending pricing and reimbursement processes, both products could generate sales in 2010, and could contribute to sustain the base business in the years to come."


"Free Cash Flow has reached € 206,4 mill despite the acquisition of linaclotide European rights (US$ 40 Mill downpayment + US$15 Mill of equity following positive phase III CC data) and milestone payments to GW Pharma (GBP 8 Mill) after the positive Phase III and continued regulatory progress of Sativex®"

Pound drops to 9 month low against Dollar

The possibility of an extension to the U.K.'s asset purchase (quantitative easing) programme and fears of a Hung parliament added to a bearish slant on the British pound. Sterling hit 1.52 against the U.S. Dollar, a 9 month low and an 11 month low against the Japanese Yen. Despite rating agency Moody's saying that Greece's credit rating would be downgraded if the fiscal debt reduction measures were not actioned, the Pound even fell against the Euro. Currency traders are looking for a safe haven, but they seem to be few and far between. Investors have a choice of a debt engorged America or Europe, Japan weighed down with all sorts of problems (ageing population, deflation, debt etc.) or emerging markets with all their intrinsic risks. Maybe gold looks the most solid bet given all this uncertainty. A tough trading environment for currency speculators that's for sure!

PIIGS debt may cause global economy to stumble in 2011

The debt default worries of the PIIGS European economies (Portugal, Ireland, Italy, Greece, Spain) look increasingly to be disregarded by the markets after the worries of last week. In order to safeguard the integrity of the Euro, there is significant political pressure for the more economically strong countries such as Germany to step in to the weaker economies such as Greece. However for politicians like Angela Merkel to sell any bail outs to their electorates is a difficult task. Greece and the other PIIGS countries are seen by French and German voters as having brought their problems on themselves through bloated state pension schemes, poor tax collection, excessive spending and an inability for politicians to tackle powerful unions.

For the Euro to collapse would be embarassing for European leaders and therefore it is unlikely to happen. But the scale of debt rollovers is so large that it may become a huge issue as international bond investors refuse to take on the risk especialy if PIIG polititicians won't take the difficult decisions and cut their budget deficits or raise taxes. Either route may mean that these politicians are voted out of office at the next national election. So these countries are stuck between a rock and a hard place! Without the flexibility to devalue their currencies, which countries like Greece used before the Euro, things are looking bleak for these heavily indebted economies. Suddenly the U.K.'s decision to keep the pound looks good for the British economy especially with the debt being racked up in the recession. Overall I fear that the glut of debt in Europe and the U.S. will come back to haunt the stock markets of the world in late 2010 and 2011, especially when stimulus spending comes to an end in the United States.

Disapointing Nighthawk Energy update from Jolly Ranch project forces sale

Nighthawk Energy (HAWK) announced a further update from its Jolly Ranch shale oil/gas prospect this morning. The market was unimpressed with a 10% fall to 26.75p as the company issued very much a “jam tomorrow” story and this disappointed many short term traders. Although production is expected to ramp up from 150 barrels per day gross (BPD) to 1000 BPD by end 2010, 1000 BPD was originally talked about by end of 2009. It has been clearly stated by MD David Bramhil that Nighthawk is in the game of proving up the Jolly Ranch project not making it a producing asset at this stage. However, solid production flows from the test wells are needed to attract outside interest. The flows from the horizontal drilling seem to have disappointed since the company is now focused on marketing the project on the basis of the economics of vertical wells –“With these assumptions and taking account of all royalties and production taxes, plus applicable regional and federal taxes, the discounted cash flow over the life of the well has been estimated to beUS$4.7 million, providing a rate of return on the cost of the well of 330% on a discounted basis. On this basis, capital expenditure on the well pays back in less than six months”.


HAWK said this morning that $18 million of cash and liquid securities was still available but given the cash burn to date, it is unlikely that funds will be available after the fourth quarter of 2010 at these production rates. I believe a takeover is unlikely until 2011 when more robust production data is available. Although news on the Revere project is still awaited, the risks of HAWK now seem to significant given the longer term “proving up” story on the Jolly Ranch project and the patchy flow rates to date. Regrettably I have decided to “kill a weed” this morning and I have sold my holding in the company at a 30% loss to focus on other more short-medium term opportunities. Such is the way with shares, that it is hard to sell a loser. But my funds are better invested in stocks such as GW Pharmaceuticals (GWP). These small caps can be rich winners, but painful losers! When selling a stock, it is always right to look at what the future gain will be on your asset if you invested it elsewhere, not on what your current loss is.

Glaxo's Avandia diabetes drug drags down share price

Glaxo Smithkline (GSK) fell 2.6% yesterday to finish at £12.03 following reports in the The New York Times that the future of its diabetes drug, Avandia, was a matter of "fierce debate" within the U.S. Food and Drug Administration (FDA) because of ongoing concerns about its side effects on the heart. On Saturday the Senate Finance Committee released a report critical of Avandia and the FDA.

However, the problems should be seen in context. In 2009, Avandia represented only £0.8 billion in global sales compared with the company's £30 billion in global revenue ($44 billion) and it is due to go off patent in 2012.

GSK's strategy to grow its business in emerging markets and maintain diversification by having both a pharmaceutical and consumer segment seems smart. With a forward price/earnings (p/e) of 10 and a dividend yield over 5%, any further weakness below £12 seems a good entry point for a medium term return. 

Desire petroleum suffers from buy on rumour, sell on fact

After rising as high as £1.32, Desire Petroleum (DES) fell back with a bump to finish the day down 4p at £1.13. At 3.30pm the long awaited RNS was released which said that the Ocean Guardian had spudded the well at 14.15 GMT. Further news will be released after the 30 days of drilling. For most traders in this stock, and there are many, 30 days is a long time to wait. Without any news flow DES will inevitably drift for a while until rumours from the rig begin to leak. But Contrarian Investor is a little patient so after closing my position at 128p, I have bought back. This one is too volatile to stay on the sidelines for too long. Nice to see FOGL staying in positive territory. I am sure that further rises are on the way.

Upward move in DRAM memory chip looking positive for Micron Technology

Micron Technology (MU) opened above the $9 mark today as isuppli forecasted that  Global DRAM sales are expected to rise 40 percent this year, ending three consecutive years of decline.DRAM chips are used mainly in PC's. Global revenue was forecast to rise for dynamic random access memory (DRAM) chip sales this year to $31.9 billion, up from $22.7 billion last year (+40.5%) and 45% up from 2008 levels. Volume and price per chip are expected to continue rising through 2010.Unlike past trends in the highly cyclical industry, iSuppli believes the current upcycle will not be followed by rapid declines in revenue and price growth in following quarters.

No stopping stampede for Falkland Island Oil shares

The Falkland Oil drillers continued to power ahead this morning as the Ocean Guardian Rig starts drilling on the Liz field: Desire Petroleum (DES) 129p +10%, Rockhopper (RKH) 76.75p +10%, Falkland Oil and Gas (FOGL)159p +5.3%, Borders and Southern (BOR) 69p +2.2%. The North Falklands basin drillers, Desire and Rockhopper are getting the majority of the action given the relative rates of news flow from the Northern and Southern basins.

News flow from Desire Petroleum and Nighthawk Energy

Desire Petroleum (DES) began drilling on its prospect in the Falkland Islands this morning. It would be surprising not to get an RNS updating shareholders during this week. Falkland Oil and Gas (FOGL) and BHP's announcement on hiring of a deep water rig for their South Falklands prospects should also be due any week now.

The key seismic and production information from the Jolly Ranch and Revere projects is expected from Nighthawk Energy (HAWK) this week. Should either be a highly exciting or demoralising news release for HAWK shareholders!

Portfolio Update - February 21st 2010

The market’s had a good week, with most of the major indices up 3% or so. Sentiment seems to have turned positive over the last 2 weeks after the negativity early in February. One of Contrarian Investor UK’s principles to maintain adequate diversification is being broken this week as my portfolio is too heavily weighted towards GW Pharma and the Falkland Islands Oil companies.  But the “binary bet” on the success of GW’s Sativex cannabis spray for Multiple Sclerosis is far too tempting a target. The previous application for the drug was rejected because of inadequate clinical trial data. This was addressed with an additional phase III clinical and the new application made for a European licence in the summer of 2009 looks very strong.  I have used Contract’s For Difference (CFDs) to limit the downside risk to 20% or so, but approval should move GW Pharma up at least 50-60%. As for the Falklands Oil drillers, all the hype and TV/press coverage is just too tempting to exploit and again the upward move on these shares will be so significant that a guaranteed stop loss using a CFD seems a sensible trade, albeit a gamble. “Fortune favours the brave”.

Coal of Africa (CZA) – Significant upward move in this share price this week on no news from 130p range to a high of 153p. Positions closed despite long term conviction in this stock, especially as Vele mine approval was finally given this month.  This strategy appeared to have paid off on Friday with CZA falling as much as 5% at one point. I will watch for a potential re-entry point if the positive market sentiment turns for the worse.

GW Pharma (GWP) – Still no news on the Sativex European approval but given the timings of the Decentralised approval process (DCP) for drugs in Europe it would be expected that news is not far off.  Have increased position once again at 87p.

Falklands Islands Oil (Falkland Oil and Gas –FOGL, Desire Petroleum – DES, Borders and Southern Petroleum BOR) – Its been an exciting week for the Falklands Oil stocks as Argentina issued a decree that any vessel passing through its waters would need a permit to visit the Falklands which made investors somewhat nervous. On Friday, the Ocean Guardian Rig, contracted by Desire Petroleum arrived on the Liz field in the North Falklands basin and is due to spud this afternoon. I took the opportunity to top up my holding in Desire Petroleum despite some reservations about my significant exposure to the Falklands Oil sector. The risks are significant but the geology of the Falklands basin and oil finds in the previous drilling campaign by Shell/Lasmo gives more than hope that oil will be found in economic quantities. If the Ocean Guardian Rig does strike it rich then I would expectd Desire’s share price to be closer to £20 than 1 so the risk/reward ratio still looks enticing despite the strong run up in the Falkland Island Oil shares. Falkland Oil and Gas and Borders and Southern Petroleum have been relatively benign for a couple of weeks now, so a rise in these Southern Basin stocks would be expected on any news from the Northern Basin drilling campaign.
Nighthawk Energy (HAWK) - Nice move back up from 27p to just over 30p as the company announced the appointment of a new non-exec. director. News on Jolly Ranch should be imminent and therefore I am hopeful of a solid move towards 40p in the next week.

ITV (ITV) – A move up from below 50p to 53p as news on potential government approval of Product Placement on UK TV came through. Position still in deficit but given TV market revenue rebound in both January and February, outlook looks positive.

Amgen (AMGN) – News was received this week that an opinion on the FDA application for Prolia (denosumab) would be received by end July. I have trimmed by position a little this week because of a shift in the portfolio to GWP and the Falkland’s shares but will look to top up in the next few weeks.

Intel (INTC) - Position closed at $21.7, following a good rise in the semiconductor stocks this week. I like Intel long term but it trades within a range of $19-$22 so a move to the upper end triggered a sale.

Micron (MU) – The worst performing stock in the portfolio but Micron continues to rebound from its lows close to $8 to finish Friday at $8.9. Holding

FDA decision on Amgen's Prolia by end July 2010

The U.S. Food and Drug Administration (FDA) has accepted Amgen's (AMGN) application for its osteoporosis drug Prolia (denosumab) and will make its approval decision by July 25, the company said on Friday.The FDA asked Amgen last October to provide additional information before it would proceed with its review and the company submitted its response in late January. A European decision on Prolia approval is expected in the first half of 2010.

Desire's Ocean Guardian Rig arrives on Liz field

Channel 4 news web site has just published a story that the Ocean Guardian rig drilling for Desire Petroleum has arrived at the Liz field in the UK exclusion zone off the Falklands Islands.   Position topped up at 110p.

PRODUCT PLACEMENT AND IMPACT ON ITV REVENUES

Paid for product placement on TV is currently outlawed in the UK and as recently as March 2009, Andy Burnham, the Secretary of State at the time, showed no signs this was going to change. He stated he had “very serious concerns” about the relaxation of product placement laws because it was “blurring the boundaries between advertising and editorial.”. Six months on, the new Secretary of State, Ben Bradshaw, is expected to make an announcement this week at the Royal Television Society which will pave the way for relaxation of the rules on commercial television. A consultation is expected to take place over the next three months with changes, if they are to occur, being implemented next year. A change in the rules has the support of the Conservatives and the Liberal Democrats so even a change in Government next year is unlikely to affect the outcome of the consultation.

Currently producers of UK TV programmes are allowed to include “real” products as props in the production of television programmes. As a result an industry that has grown out of this need in which placement agencies are paid by advertisers to arrange for their brands to be placed into TV programmes by providing the product as a free prop to production companies. This saves the producers money as they don’t have to buy the products they need and, for the client, they get some “free” exposure for their placed product. However, due to the rules preventing undue prominence of products in programmes, the exposure brands get is normally small, uncontrolled and incidental. This, in itself, is not a problem as the money invested by the brand is usually a relatively modest fee paid to the placement agency, in return for what can be potentially high profile media exposure.

What might happen?
At this point no one knows what the Government policy will be on this matter as they seem set to take a significant u-turn in the space of just six months. It seems, however, increasingly likely that some form of paid for placement will be allowed on commercial TV from some time next year. In other words, brands will be able to pay for the right for their product to be featured in the programme, in return for a certain set of contracted rights and benefits from the producer of the programme. This has divided the commercial television broadcasters with ITV keen to see the rules relaxed, whilst the likes of Channel 4 and many of the others less enthusiastic. ITV are the broadcaster and the producer in many cases, while the others are largely just broadcasters who are commissioning the programmes for the independent producers - it’s more difficult for them to see the commercial benefits.

The Arguments in favour of relaxation are;
• Product placement already exists in Film and imported US TV programmes which are broadcast, unedited, in the UK. Viewers are used to it and it levels the playing field for UK producers
• Content broadcast online is not regulated and product placement is common place in dramas such as Kate Modern and Sophia’s Diary
• Real products lend credibility to programmes; it makes the programmes more “real”
• Product placement in programmes gives credibility to brands
• It can help change consumer behaviour by allowing advertisers to demonstrate how they want their products to be used e.g. new mobile phone functions
• Media exposure can be easily measured and priced
• Advertisers who fund TV shows will be able to include their products

The Arguments against are;
• It will blur the lines between editorial and advertising causing viewer confusion and/or cynicism
• Editorial integrity will be compromised by the demands of the advertisers who have their products placed
• The use of the product is not controlled so that clients run the risk of inappropriate use of their product or it being placed in a bad light e.g. brake failure on a car, skin issues from cosmetics etc
• You might be able to put a price on exposure but if it’s subliminal how do advertisers put a value on its effectiveness?
• Paid products placed in programmes could be ambushed by brands who sponsor the programme unless safeguards are put in place
• Logistically and contractually complex to deliver
• A marginal commercial benefit for significant editorial compromises

Figures of £100 million in product placement revenues have been banded around, but this seems to be a long term goal. If this iniative is allowed, this is good news for ITV revenues and therefore shareholders though the actual effect on the bottom line may not be felt to a great extent for many years.

2/3 of S&P 500 companies have beaten on top line

This morning I was listening to the the excellent and highly recommended S&A Investor Radio Podcast by Frank Curzio (available for free from the Itunes store). Frank interviewed head of research for TheStreet.com's Action Alerts portfolio (Jim Cramer's Charitable portolion), Stephanie Link, and she cited the statistic that 2/3 of companies that had reported so far in the S&P 500 had beaten on revenues. This is an interesting statistic since it indicates that perhaps economic recovery in the U.S. is better than expected as the hypothesis has been that aggressive cost cutting has grown bottom line profits but the sales revenues were still weak due to low economic activity.The U.S. economy looks to be set for good growth in the next 6 months, helped by the continued stimulus package.The continued deficit issues make the back end of 2010 and 2011 much more hazy.

Although I have been selling down portfolio positions over the last week to bank some profits in stocks such as Coal of Africa (CZA), Intel (INTC) and Amgen (AMGN), any significant weakess in the markets is very much seen as a buying opportunity for favoured names. Certainly a trading market, not a buy and hold by any means!

Coal of Africa positioned offloaded on share price strength

The holding in South African miner Coal of Africa was sold yesterday as the price surged to £1.53. The price is off nearly 5% today to £1.46 as commodity prices have been under pressure as the U.S. dollar has risen on the news that the Fed has tightened the discount window for emergency funds. CZA rose from around £1.30 earlier in the week and moved to a year high (marginally higher than the Vele mine approval news day). Although it is considered a great long term play, a 15% rise on no news is seen as a selling opportunity particularly given the U.S. and UK markets have shown a strong rally since early February. Overall Contrarian Investor has been trimming holdings on the market strength.