Obviously, the issue is cash/potential dilution. Ideally, they will partner something in the pipeline for some up-front money and avoid any ATM transactions, but the "market" is not going to wait and see - they are bailing out.
So, Q2 sales will probably come in around $12M - then in order to hit the current annual revenue estimate of $49M, they need to do $30M of sales the rest of the year, which should be no problem - 20% sequential growth from $12M would be $14.4M in Q3 and $17.3M in Q4. I wish they would have put a stake in the ground and confirmed an annual number - saying that the run rate is $45M-$50M in Q2 without any further growth may give the impression they are not counting on significant growth going forward?
I was going off Yahoo's key stats table - they report Debt of $8+B and TTM EBITDA of less than $1B? I didn't see any EBITDA reported in the earnings release, but then the narrative speaks to a 4X ratio? Did they have a big acquisition in the past 12 months that would distort the TTM EBITDA number?
By comparison, Valeant's Debt/EBITDA ratio is only about 6-times - debt of $30B vs EBITDA of $5B. A ratio of 6X is considered high - 9X is negligent!
Their Debt/EBITDA ratio is 9+ times - that may be sustainable when everything is rosy, but any kinks in the revenue or profitability outlook will make that ratio look dangerous - the shares are basically an option at this stage.
A lot of redemptions going on in the hedge fund industry recently, most likely in funds that were long biotech - those that have been short since the beginning of the year have some happy investors. The political environment created by Valeant, Shrekl, etc. certainly hasn't helped - even if your company isn't part of the the acquire and gouge business model, it will still get caught up in the downdraft.
Based on early experience by the hospitals, it is becoming clear that they are trusting the T2 to make decisions about treatment - the one hospital tests the patients twice - once to determine if anti-fungal treatment is needed and second to see if the infection has been cleared. Initially, the company was very hesitant in their speculation on whether T2 would replace blood culture, but it is clear from the experiences they are hearing from the hospitals using T2 that blood culture will ultimately be replaced by T2. The bad thing is that some of the hospitals (15%-20%) are waiting for the bacteria panel to be available before they commit to the system. It is understandable to wait 6-9 months to avoid separate approval and implementation efforts, but how much money and how many lives will be wasted in the interim?
No doubt - "we will see" is the operative word in the biotech world these days - most of the speculative value has been wrung out of the market. I am still hopeful NVDQ will ratchet the growth rate up in the 2nd half, but Arun needs to show he can start producing or they need to bring in someone else.
When CFO's leave "abruptly" to join another company, it may be a sign of bad things about the company, when a CFO retires before his contract is up, it is usually due to health/family issues - who knows, his wife may be sick and he is retiring to be spend more time with her. Did you listen to the earnings call, what possibly do you think they are hiding - that they closed only 4 contracts in Q1 vs the 5 that were reported?
Relax, sparky - the guy is 65+ years old - he may have some health issues that he needs to deal with and does not want them disclosed publicly. You can fault the BOD for hiring someone that old, but I doubt he signed a contract thinking he was going to retire in 8 months or even if he was thinking about retiring, I'm sure he told them differently. Either way, the CFO leaving is not a big deal to a company at this stage of their life cycle.
GSA - Are you trying to model what you think is going to happen to the sales number if the metrics hold or are you looking for flaws in their marketing program?
copp - after watching most of the AdCom, I am curious as to what the formal rules of "engagement" are for these panels. From what I could tell, the sponsor has no right to question or challenge any of the FDA's presentation (and vice versa) and when it came to the panel discussion and voting sessions, the sponsor was not able to join the discussion to clarify or correct any points unless someone on the panel asked them to. This doesn't lend itself to a very healthy analysis of key issues and the panel discussions reflected it - they seemed more bewildered than definitive in their conclusions and voting.
bionerd - the most disturbing thing to me was that all of the FDA's "evidence" against Etep's clinical efficacy was grounded in the comparison of the Etep boys to age-based natural history. I didn't notice it at the time the FDA's briefing docs came out, but they emphasized in the discussion of of the comparison to the CINRG loss of ambulation analysis that they believed the enrollment criteria for the Etep trial resulted in a trial population that was "enriched for patients with a better prognosis than the overall Exon-51 population" (see page 57). Nothing could be further from the truth and I can't believe SRPT didn't spend any time in their presentation focusing on how the FDA's age-based comparisons were not rational. At one point during the panel discussion, Kaye was desperately trying to state the point that an 11-year old with a 500-meter 6MWT ability is not the same as an 11-year old with a 200-meter 6MWT, but he was cut off and botched it. IMO, this should have been a key focus of their presentation.
Unfortunately, the AdCom did not have any real DMD experts that were able to bring this issue to light and hash it out, which would have gone a long way toward discrediting much of the FDA's analysis and presenting the data and experience of the Etep boys in the proper light - i.e. these boys were selected because they were on the verge of losing ambulation within a year or two and not outliers that would be expected to remain ambulant until for 4 years.
Just proves how stupid Cramer is if he thinks this opens the door for Drisa - the FDA would never approve that drug for safety reasons and given their history of failed efficacy results, it is very unlikely they would be able to design and execute a trial that would generate a hint of efficacy, let alone a statistically significant result. BMRN hasn't disclosed their strategy for Drisa since their rejection - IMO the odds are better they scrap the program, rather than continue to invest in a no-win situation.
Are you really that clueless - SRPT had no control over what parents decided to testify - every AdCom meeting is open to public testimony for a reason and it is not because the sponsor controls the process. If you watched the AdCom it was clear that SRPT had very little control over the proceedings - they were unable to directly address the distortions presented by the FDA.
Congrats - you secured the loser post of the day before the market even opened! The parents were fighting for their children's lives and the lives of all DMD boys - their stories are more relevant than all the distorted charts and graphs the FDA pedaled out.
thig - I don't have much faith in Woodcock - I suspect she was just playing good cop to the rest of the FDA's bad cop routine to appease the parents into believing it wasn't completely one-sided?
It was clear the panel was uncomfortable with the size of the trial and the historical comparison, so there was no hope of a full approval (Question 7). The question of whether AA was warranted based on the data wasn't specifically discussed or voted upon. The "science" did not support full approval and the "politics" of the adcom panel agenda did not allow the AA issue to be decided.
Was whether the "totality" of the data (including the parent/patient/doctor testimonies) was sufficient to warrant AA. Question 3 was whether the dystrophin results on their own were sufficient to predict a reasonable likelihood of clinical benefit and Question 7 was whether the data warranted full approval, which was never really a possibility. Not sure how the panel would have voted on that one - it was difficult to figure out if they simply didn't believe in the historical control comparison presented by SRPT (or the n was too small) or if they really bought into the distorted comparisons presented by Farkas? What is clear is that there are flaws/complications in both the 6MWT and dystrophin measurements that may not be resolved simply by increasing the N?
He dismissed Christine McSherry's "data" on falls before and after Etep as unscientific, but considers Farkas' quotes and data references from other studies/trials as more relevant? It is hard sometimes to figure out what AF's agenda is, but intelligence certainly isn't part of it.