We have a cc approaching on Nov 7, and a case management conference before the judge on Nov6.
On Aug 9th the Federal Circuit Court on appeal overturned a previous District Court ruling that was unfavorable to Sequenom. In a scathing reversal of the District's Court original ruling, a unanimous three-judge-panel of the Federal Circuit Court vacated, reversed, and remanded the case back to the District Court's Judge Susan Ilston, to [in essence] "...try it again, do it right this time, give Sequenom the injunction against Ariosa that it was seeking..."
The recent (Oct 2013) Motion for Summary Judgement before the same Judge Susan Ilston saw her reading from a completely different playbook as her comments indicated a 180-degree shift in favor of Sequenom, and consistent with the guidance and direction provided to her by the Federal Circuit.
Meanwhile, Sequenom continues licensing it's MaterniT21+ technology overseas where it's patent has already been tested and upheld in Europe.
The 2nd Quarter conference call was weak, due to Medicare reimbursement issues that resulted from "coding changes" at Medicare. This "coding change" issue was felt across the entire landscape of companies that perform genetic/lab diagnostic testing; heavy hitters such as LabCorp cited this problem as having an impact on their bottom line. These issues are expected to be mostly resolved now, but there may be lingering effects seen in the 3rd Qtr results of all these companies.
Since the start of the year, we have seen BCBS sign on to agreements with Sequenom, and we have seen several of the other major insurers updating their coverage policies to allow for reimbursement of NIPT such as MaterniT21+ specifically.
Last CC Sequenom warned that they would stop performing tests for non-payors, and whil this would help the bottom line it might lead to a relative decrease in the acceleration/trajectory of the run rate. Considering the changes in policies coming out in the past few months,
Its simple considering how much they overpay themselves they need to do the following:
1. Exponential quarter over quarter growth in volume of tests. And oh by the way not a bunch of non revenue freebies they provide to hype the volume #
2. Premium pricing $1400+/ test
3. Complete disclosure and transparency regarding the illegal insurance capping scheme they had in place (maybe still do)
4. While we are on the subject of transparency how about as it relates to collections and AR
Anything less than the above is a complete waste of money- their competitors have half the expense in sales and G&A and appear to be out selling SQNM at every turn.
Sentiment: Strong Sell
LMAO "appear to be out selling SQNM at every turn " they are price dumping !!! why do you think verinata / illumina never reports verinata's numbers to the public. because they trying to destroy sqnm before court litigation ends.
Awesome post, Avranj! Thanks!
Lots of FDA stuff coming down the pike soon, also.
List of SQNM's recent & Upcoming FDA-related activities:
June 2013: Completed FDA study for Factor II and Factor V Leiden Genotyping Test.
September 2013: Completed FDA study of T21 test in HIGH-Risk pregnencies.
October 2013: Submitted Premarket 510(k) Notification to FDA for Factor II and Factor V Genotyping Test (now called IMPACT)
December 2013: Will complete FDA study of T21 test for LOW-RISK pregnencies.
It would be nice to get more PR's about this stuff.
Do be fooled by the passive way Sequenom releases information - you wrote -
""Submitted Premarket 510(k) Notification to FDA for Factor II and Factor V Genotyping Test (now called IMPACT)""
The 510k approved sumbittal was actually for the Impact DX "system'"as well as the (pilot test 510k process) approved submittal of the Factor test. That is IMPACT DX SYSTEM & FACTOR TEST
Sentiment: Strong Buy
The timing of the Quarterly conference call on November 7th is perfect, as they can address the ongoing's of what happened with Judge Illston on November 6th. Although we won't get anything definitively, we should see clearly that the tables have turned and there is a good chance for Sequenom's victory. If they are victorious on the legal front, this stock will be in the twenties, two years from now.