1. Zero
This is the number of anaphylactic events that have occurred in patients with kidney disease taking Rockwell Medical's anemia drug Triferic. That's out of more than 100,000 doses given.
Why is this number so important? Anaphylactic reaction is listed as a serious adverse effect for Amgen's (AMGN -1.65%) market-leading anemia drug Epogen. Earlier this year, Affymax had to recall Omontys after multiple reports of patients experiencing severe allergic reactions. Three of those patients died.
Triferic's positive safety profile stands out as a key benefit. Rockwell recently announced the results from a safety study conducted in support of the New Drug Application, or NDA, for the drug. The findings were solid -- no adverse events directly linked to Triferic. Adverse events that did occur among patients taking the drug also occurred in similar numbers among patients taking placebo.
2. Nine
Just nine companies control 83% of the U.S. dialysis market. Two of them -- DaVita Healthcare Partners (DVA -0.44%) and Fresenius Medical Care (FMS -2.50%) -- control 71% of the U.S. market.
This means that if Rockwell Medical gains approval for Triferic from the Food and Drug Administration, the company only has to win the business of a few customers to wrap up most of the U.S. market. Even better news is that Rockwell already claims most of these nine as customers. DaVita and Fresenius actually participated in the phase 3 clinical studies of Triferic.
3. 35
Rockwell's research shows that Triferic reduces the need for expensive erythropoiesis-stimulating agent, or ESA, drugs like Amgen's Epogen by 35%. The impact of this on dialysis providers is enormous.
DaVita, Fresenius, and other providers of dialysis services spend around $2 billion each year on ESAs. If Triferic could reduce their costs by 35%, that would equate to $700 million in annual savings. Even if the actual reduction is well below the 35% ESO reduction that Rockwell found in its study, we're still looking at big savings for dialysis providers.
4. 2.3 million
A really important number to keep in mind is 2.3 million. That's how many dialysis patients across the world are estimated to suffer from anemia -- and the number is growing by 5%-7% each year. Only 436,000 or so of them are in the U.S.
While Rockwell Medical is focused primarily on winning approval for Triferic in the U.S. market right now, the global market is even larger. CEO Rob Chioini said recently that the company is in discussions with multiple potential partnerships and licensing opportunities outside of the U.S.
5. 31.2 million
The biggest number on our list represents the amount of cash in dollars that Rockwell Medical had at the end of last quarter. The company says that's enough to take Triferic to commercialization.
Rockwell's stock suffered earlier in 2013 when it appeared that cash would run too low. A secondary stock offering and debt financing deal helped alleviate those problems. With clinical studies ending, the company's cash outflow should decrease considerably, allowing Rockwell to stretch that $31.2 million out for a while.
A couple more numbers
All five of these numbers point to a couple of other numbers that should interest investors. Sales of Triferic are projected to hit close to $250 million annually. That figure doesn't include other products sold by the company. Rockwell Medical's market cap currently stands around $500 million.
Rockwell's stock seems poised to go up considerably from current levels if Triferic gains FDA approval. Keep in mind that nothing's ever a certainty when it comes to the approval process. However, the drug's efficacy and safety profile look solid. The odds of approval should be pretty good. At this point, the numbers for Rockwell Medical seem to add up nicely.
