Pernix Therapeutics Holdings Inc. (fka PTXTQ)

[humboldt111502]

Pernix Therapeutics Investor Watchlist: updated 7/23/2016

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12% Treximet note interest payment due and premium to pay off drops from 106-103%:

Aug 1

(debt restructure news could come soon after)

After Aug 1, company saves 3% on the principal owed on Treximet notes, equating to around $6m in possible savings.
Then company should refund/refinance the existing 12% bonds by purchasing the outstanding bonds at 3% premium above
principal owed at time. After refunding old notes, issue new ones with lower interest rates (4-5%) and better terms.
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New Jersey Annual Report Due (will have to report current directors, etc):

Due by July 31 (last day of the anniversary month of the entity's formation)

Filed on July 22nd last year.
(possibly followed up with PR confirming CEO to be Sedor)
(possible ammendedments to articles of incorporation in Maryland around same time)
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PR confirming ER date/guidence on earnings:

~ July 28-29

(ER date has NOT been postponed since it was never confirmed yet. No reason to
think it would be delayed though. Aug 15 by absolute latest)
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Q2 Earnings report:

~ Aug 4, 8am

2015 Q2 had $47m rev, street estimates for 2016 Q2 only $40.33m

Positive Trx uptrends for core 3 meds - confirmed by Matt Duffy in recorded call.

With recent Q2 Trx data suggesting possibility of revenue approaching $47-50 mil in Q2,
there is high chance of meeting or beating Q2 2015 numbers AND exceeding current street
estimates by an estimated ~$6-10m. EPS probably still negative, but much improved over Q1.
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Institutional quarterly holding report 13f-HR's due by:

2Q 2016 (June) August 15, 2016 (Monday)
3Q 2016 (September) November 14, 2016 (Monday)
4Q 2016 (December) February 14, 2017 (Tuesday)
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FDA Final Action on Pernix Citizen Petition:

Estimated Tuesday, Aug 23rd. (180 days after submission)
Watch for comments closing on regulations.gov
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Attending PAINweek 2016 (DD suggests presentation of zx007 clinical data):

sept 8th
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gsk vs pernix: (relating to treximet deal)

arbitration hearing was held in April 2016
second hearing is scheduled for August 2016.
A decision by the arbitrators is expected in October 2016.

if lose will have to pay ~$15m more to GSK
if ruled in favor, PTX should get payment upwards of $50m from GSK
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ZX007 (zohydro with intellitab) category 3 abuse potential study results / NDA submission:

sometime 2016 (probably after being presented at painweek in Sept)
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Treximet Phase IV Trial on Workplace Migraine Treatment in progress (NCT01086358) :

Verified nearing full enrollment (59/60 patients) June 24 from recruiting doctor
Unknown when to expect news (possibly fall or winter)
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Silenor OTC study completion:

mid Q3 (August)
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Treximet alternate dose study completion:

mid Q3 (August)
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Pernix vs Actavis/Alvogen: (related to generic zohydro entry)

- pernix sues both companies after submitting generic ndas (march)
- pernix ammends/strengthens complaint with 3 new Zohydro patents in May
- during pre-trial motions... actavis/alvogen argue zohydro patents are not enforceable (july)
- pernix repsonds with strong argument that actavis/alvogen claims on invalidity are frivolous
(no ruling on motion yet)
- pernix notifies court they will file preliminary injunction to extend blocking generic entry
until case settled (unless defendants agree voluntarily) (7/20)
- trial scheduled for December unless timeline changes

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Final conversion of Silenor ot OTC market:

mid 2018 (evaluating go-it-alone launch vs partnership with OTC leader)

Following guide path laid out by meeting with FDA:
-Label comprehension study
-Transient Study – healthy subjects
-Actual use study

(news on studies unknown)
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Silenor approved and launched in Canada with partner (Paladin), Approved in
Korea with partner (CJ) and potential for Japan is large (doxepin never
approved):

(Paladin also has right to launch in South America)

unknown when to expect news
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Silenor possible combination/alternative isomers formulas:

Discovery Phase – IP Filed (unknown when to expect news)

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Possible Buyout (minimum price target of $3.00):

Sometime after Aug 1 2016...

Probably after refinancnig debt, paying more of it down, couple positive Earnings reports,
patent litigations are over, and zx007 launched (maybe early 2017).
Read "Speculating on Pernix" for detailed article on buyout scenario:
http://seekingalpha.com/article/3979465-speculating-pernix-therapeutics
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(always do your own DD, use this information at your own risk)