Make a lot of money. Lose a lot of money. Investors in biotech Spectrum Pharmaceuticals (SPPI +0.00%) could have done either during the last seven months.
From mid-April through early July, shares soared more than 80%. If you bought Spectrum in July, though, you're probably not a happy camper. Shares have dropped more than 36% since then.
Can Spectrum reverse course with its upcoming quarterly earnings results? Here are three things to watch that could make a difference.
1. Will Raj walk the talk?
In August, Spectrum CEO Rajesh Shrotriya told attendees at the Southern California Investor Conference the company would hit $300 million in revenue by the end of 2012. Third-quarter results will indicate how realistic his prediction actually is.
At the end of the first six months of 2012, Spectrum's revenue totaled $128.5 million. If we add revenue for Allos Therapeutics, which was acquired in September, the combined revenue for the first half of the year tops $153 million.
Reaching $300 million in revenue certainly appears to be feasible for Spectrum. If results from the third quarter show an even better growth rate than Shrotriya's projection, shares could begin another up swing.
2. Will generic rivals to Fusilev affect sales more than expected?
Continued strong sales for Fusilev are critical for Spectrum to reach the $300 million mark. The possibility exists, though, that generic rivals could begin to make a dent in sales.
At least two of the manufacturers of generic leucovorin are still encountering manufacturing problems -- Bedford Labs and Teva Pharmaceuticals (TEVA 3.31%). Another entrant, Sagent Pharmaceuticals (NASDAQ: SGNT), also recently began selling the generic drug.
Spectrum points to several factors that the company feels are in its favor. First, Fusilev is a purer form of leucovorin called levoleucovorin that has its own reimbursement J-code. Second, the company notes that generic leucovorin shortages have not affected Europe, yet Fusilev continues to grow strongly there.
The first point is important. Oncologists are reimbursed more for Fusilev than they are for generic leucovorin. Some observers have stated that Spectrum is cutting prices on Fusilev to make the drug even more attractive to doctors. If prescribing Fusilev makes financial sense for oncologists, logic seems to dictate that they will prescribe it over alternatives.
With short interest topping 60%, many seem to think that the generics will take their toll on Fusilev. Another strong quarter won't necessarily prove them wrong, but it could convince some investors that Spectrum's positive outlook for Fusilev isn't just hype.
3. How is assimilation of Allos progressing?
One wild card could be how the assimilation of Allos Therapeutics is progressing. While the acquisition was only finalized in September, Spectrum has already announced an expansion and restructuring of its sales force to promote the company's broadened product portfolio.
This appears to be a good move. Other pharmaceutical companies have taken similar steps. Questcor (NASDAQ: QCOR), for example, increased its sales force several times over the last few years with great results. Horizon Pharma (HZNP +0.00%) also recently announced that it was nearly doubling its sales staff.
There probably won't be any hard numbers in the quarterly results to indicate any good or bad developments with the integration of Allos. However, management comments in the earnings conference call have the potential to provide investors reasons to be encouraged or discouraged.
Predictions
My prediction is that this quarterly results release will be solid. However, I also predict that it won't be enough to change the opinions of many naysayers. Until the generic manufacturing issues are resolved, doubts about Fusilev's ability to compete will linger.
However, if the earnings results are strong enough to bring some investors off the sidelines, the short-sellers could begin covering their shorts, and a new surge could begin. We shall soon know which scenario plays out.
