June 4, Jefferies Global Healthcare Conference

Transcription

1 June 4, 2015 Jefferies Global Healthcare Conference

2 Safe Harbor Statement The following presentation includes forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of You should be aware that our actual results could differ materially from those contained in the forward looking statements. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties inherent in our business including, without limitation: the rate and degree of market acceptance of, and our ability and our distribution and marketing partners ability to obtain coverage and reimbursement for, any approved products; our ability to successfully execute our sales and marketing strategy, including to continue to successfully recruit and retain sales and marketing personnel in the U.S.; risks associated with our acquisition of certain assets related to the product Zohydro ER from Zogenix, Inc. ( Zogenix ), and the hiring of certain employees of Zogenix related to the Zohydro ER business, including our success in hiring certain of the Zohydro Employees and ability to manage such employees, and our ability to successfully integrate the Zohydro ER business into our operations and realize the anticipated benefits of this acquisition; our ability to obtain additional financing; our ability to maintain regulatory approvals for our products; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to manage our anticipated future growth; the ability of our products to compete with generic products as well as new products that may be developed by our competitors; our ability to comply with regulatory requirements regarding the sales, marketing and manufacturing of our products; the performance of our manufacturers, over which we have limited control; our ability and the ability of our partners to obtain and maintain intellectual property protection for our products; our ability to operate our business without infringing the intellectual property rights of others; the success and timing of our clinical development efforts; the loss of key scientific or management personnel; regulatory developments in the U.S. and foreign countries; our ability to either acquire or develop and commercialize other product candidates in addition to our current products; and other risks detailed in the section titled Item 1A. Risk Factors in the Company s Annual Report on Form 10-K for the year ended December 31, You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Pernix is a registered trademark of Pernix Therapeutics, LLC. Other trademarks referenced herein are the property of their respective owners Pernix Therapeutics Holdings, Inc. 2

3 Investment Highlights Rapidly growing specialty pharmaceutical company In-market products & pipeline opportunities focused in pain & CNS markets Dedicated 200-person specialty sales force building 3 core brands Proven, integrated commercial platform Compelling financial performance 2014 (A) 2015 Guidance Net Sales $121.7m $220m - $240m Adjusted EBITDA $23.8m $45m 55m Attractive pipeline of business development opportunities in target markets 3

4 Pernix Commercial Footprint Pernix Sales Force (200) Neuroscience Specialty Sales Force Pain Management Specialty Sales Force 4 Further leverage through future acquisitions

5 Treximet Overview Product Overview Approved 2008, re-launched Sept Serves unmet need in migraine abortive therapy Acute treatment of migraine attacks with/without aura Adults Pediatric patients aged 12 years Once-daily oral combination therapy Fixed dose combination Bi-layer tablet with dual MOA Large Market Opportunity million triptan Rx dispensed Treximet market share: 2% (by volume) 1% market share gain = $110m sales Growth Strategy/Tactics Sampling started week of 3/23 Accelerating growth in both TRx and NRx since sampling began Positive wholesaler ordering patterns in May Marketing activities ramping in 2Q Pernix Pharmacy Direct 5

6 Treximet Progress (weekly TRx) 6,000 5,500 5,383 Samples become available to sales force 5,000 4,500 4,292 4,635 TRx 4,000 3,500 3,000 Pernix Therapeutics closes acquisition of Treximet and begins promotion Call deck optimized 2,500 2,000 Treximet TRx 6 Source: Symphony Health Source Pharmaceutical Audit Suite (PHAST).

7 Silenor Overview Product Overview For the treatment of insomnia characterized by difficulties with sleep maintenance The only non-controlled prescription sleep medication for people who have trouble staying asleep Re-launched mid-2014 Weekly TRx reached all-time high week ending 5/15/15 Large Market Opportunity 40 million people experience sleep problems in the U.S. 10% have chronic insomnia 1% market share gain = $160m of sales Growth Strategy/Tactics Added 100 sales reps May 4, 2015 Conversion of GABA agonist market Pernix Pharmacy Direct Consumer awareness is a priority in % 7

8 Silenor Progress (weekly Rx) 3,000 2,800 2,600 2,400 Silenor Consumer Engagement 2,200 Silenor ReLaunch 2,000 1,800 1,600 1,400 1,200 1,000 03/28/14 04/11/14 04/25/14 05/09/14 05/23/14 06/06/14 06/20/14 07/04/14 07/18/14 08/01/14 08/15/14 08/29/14 09/12/14 09/26/14 10/10/14 10/24/14 11/07/14 11/21/14 12/05/14 12/19/14 01/02/15 01/16/15 01/30/15 02/13/15 02/27/15 03/13/15 03/27/15 04/10/15 04/24/15 05/08/15 05/22/15 8 Source: Symphony Health Source Pharmaceutical Audit Suite (PHAST)

9 Zohydro ER Overview Zohydro Product Overview ER with BeadTek Extended Release (ER) oral formulation of hydrocodone bitartrate with abuse-deterrent technology Combination of IR/ER beads in a capsule Launched 5/4/2015 True 12-hour dosing allows more consistent pain relief Peak plasma levels in 5 hours Inactive ingredient immediately forms a viscous gel when crushed and dissolved in liquids or solvents Large Growth Opportunity 100 million adults affected by chronic pain (U.S.) 1) 114 million hydrocodone/apap Rx written in 2014 in U.S. 2) ~30% for chronic pain Zohydro ER market share: 0.02% 1% of hydrocodone/apap TRx = $430m of sales Growth Strategy/Tactics Transitioning to Zohydro ER with BeadTek PBMs and pharmacies removing from restricted list Improve managed care access Capture hydrocodone/apap chronic pain Rx Leverage synergies with CNS portfolio 9 1) Institute of Medicine Relieving Pain in America: A blueprint for Transforming Prevention, Care, Education and Research. 2) Symphony Health Source Pharmaceutical Audit Suite (PHAST).

10 Zohydro ER Launch Progress PTX inherited two major hurdles to script growth Pharmacy stocking Payer access Pharmacy Stocking Rapid actions have resulted in 99% of PTX trade customers ordering Zohydro ER with Beadtek 2nd and 3rd largest US pharmacy chains were previously not stocking Zohydro ER All US pharmacy chains now filling Zohydro ER with Beadtek scripts Payer Access Proposals have been submitted to all major PBMs with initial favorable reaction 15 HMO Managed Care decisions to remove restrictions are pending All existing contracts have been transferred to prevent coverage gaps 10

11 Zohydro ER Snapshot (weekly Rx) Zohydro ER acquisition closed 5/4 launched Zohydro ER with BeadTek 1,800 1,600 1,400 1,200 1, /28/14 4/11/14 4/25/14 5/9/14 5/23/14 6/6/14 6/20/14 7/4/14 7/18/14 8/1/14 8/15/14 8/29/14 9/12/14 9/26/14 10/10/14 10/24/14 11/7/14 11/21/14 12/5/14 12/19/14 1/2/15 1/16/15 1/30/15 2/13/15 2/27/15 3/13/15 3/27/15 4/10/15 4/24/15 5/8/15 5/22/15 11

12 Marketing Initiatives by Product 12 New campaign for HCPs and Consumers includes pediatric indication DTC and media blitz this month (MIGRAINE AWARENESS MONTH) Bellamy Young (Scandal) media tour Online marketing, twitter activity, blogger integration and video programming on YouTube Patient programs - starter kit, educational tools, consumer website and access programs New campaign to include BeadTek technology focused on True 12-Hour Control Proactive launch to wholesalers, pharmacists and MCOs with new formulation information Updated website, advertising and SEM, including MOA video on BeadTek and direct mail to prescribers and pharmacists Patient Offerings including education materials, safety initiatives and access programs Debi Mazar (Entourage) on Modern Living with Kathy Ireland and other shows Consumer magazine advertising Online marketing, SEM, twitter blogger integration New consumer MOA video on website Patient starter kit & educational materials and direct mail to consumers and HCPs driving them to Symposium at Sleep (June 6-10)

13 Pernix Pharmacy Direct Program Enables script ownership from time it is written to when it is filled Eliminates abandonment between physician and pharmacy, increasing script fulfillment and refills 25% increase in fill rate in pilot cities Switch whole practices from zolpidem / eszopiclone to Silenor and from sumatriptan to Treximet Provide access to our products more broadly and avoid negative feedback loop to physicians Enables closer relationship with our patients 13

14 IP / Life Cycle Management Strategy Pediatric exclusivity granted 4/16 LCM Four Orange Book patents OTC Switch BeadTek ZX007 (Altus) (1) Patent Expiry Lifecycle Management 14 1) Patent rights acquired through the Zohydro ER acquisition expire in 2019 and also include the right to license additional patents from Altus that extend coverage for the ZX007 product to 2029.

15 Accelerating Financial Performance May 2014: Re-launched August 2014: Acquired CNS product from GSK Evaluating 30+ opportunities in specialty areas April 2015: Acquired from Zogenix $250 $200 April 2014: Licensing agreement with Osmotica $220 - $240m 1) in millions $150 $100 $50 $0 -$50 $122 $85 $45 - $55m 1) $ A 2013A 2014A 2015E Revenue Adjusted EBITDA 1) 15 (1) 2015E net sales based on mid-point of guidance for $220 million - $240 million; Adj. EBITDA based on mid-point of guidance for $45 million - $55 million

16 Thank You 16