(1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of...

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Oppenheimer Healthcare Conference Doug Drysdale – Chairman, President & Chief Executive Officer December 11, 2014

Transcript of (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of...

Page 1: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.

Oppenheimer Healthcare ConferenceDoug Drysdale – Chairman, President & Chief Executive OfficerDecember 11, 2014

Page 2: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.

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Safe Harbor StatementThe following presentation includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval of our product candidates, including as a result of the need to conduct additional studies, or the failure to obtain such approval of our products or product candidates; changes in regulatory standards or the regulatory environment with any of our product candidates; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; changes in industry practice; and one-time events. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission. Such documents may be read free of charge on the company’s web site, www.pernixtx.com, or the SEC’s web site at www.sec.gov. 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. ©2014 Pernix Therapeutics Holdings, Inc.

Page 3: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.

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Investment Highlights• Rapidly growing specialty pharma company with growing CNS franchise

• Opportunity to expand into adjacent TAs such as pain and women’s healthcare

• Organic growth from enhanced promotion, pharmacy and managed care initiatives, and LCM

• Re-launched Silenor in May 2014; Acquired Treximet in August 2014

• Aggressive M&A and product acquisition activity, supplemented by LCM and in-licensing

• Transformed financial profile: 2015 guidance of $230 mm of net sales, $95 mm of Adjusted EBITDA

Page 4: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.

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2012A 2013A 2014E 2015E

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0

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Revenue EBITDA

$ in

mill

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Accelerating Sales Growth(1)

(1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue of $230 million and adjusted EBITDA of $95 million. Excludes transaction related expenses and non-cash items.

Page 5: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.

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Solid Performance Year-to-Date

Three Months Ended 9/30 ($ MM) Nine Months Ended 9/30 ($ MM)

• The period ended 9/30/14 includes one month of Treximet sales

Three Months Ending 9/30/13 Three Months Ending 9/30/14($5.0)

$0.0

$5.0

$10.0

$15.0

$20.0

$25.0

$30.0

$35.0

$18.3

$31.5

($2.0)

$6.9

Nine Months Ending 9/30/13 Nine Months Ending 9/30/14($20.0)

($10.0)

$0.0

$10.0

$20.0

$30.0

$40.0

$50.0

$60.0

$70.0

$80.0

$60.9 $67.9

($7.3)

$1.0

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Quarterly Adj. EBITDA(1)

(1) 4Q 2014E and 2014E based on midpoint of 2014E guidance for Adj. EBITDA of $22 – 24 million.

1Q 2013 2Q 2013 3Q 2013 4Q 2013 2013 1Q 2014 2Q 2014 3Q 2014 4Q 2014E 2014E($10.0)

($5.0)

$0.0

$5.0

$10.0

$15.0

$20.0

$25.0

$ in

mill

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Financial Highlights• 3Q 2014 net sales up 72% year-over year, reflecting only one month

of Treximet

• Net sales for base business (excluding Treximet and divested / discontinued products) increased 20% year-over-year in 3Q 2014

• Silenor prescriptions up 41% since new promotional efforts began in May

• $6.9 million of Adjusted EBITDA in 3Q 2014

• 2014E guidance: $110 - $120 million of net sales; $22 - $24 mm of Adj. EBITDA

• 2015E guidance: $230 mm of net sales; $95 mm of Adj. EBITDA

Page 8: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.

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Seasoned Management

Doug DrysdaleChairman, President, CEOAlvogen, Actavis, Alpharma, Forest, Elan, DuPont Merck

Terry NovakCOOBMS, Innovex, DSM, Patheon, Alvogen

Sanjay PatelCFOCantor Fitzgerald, Clinton Health Access Initiative, Sectoral Asset Management, UBS

Alex MironovSVP Corporate DevelopmentAlvogen, Inspirion, Pfizer, Ranbaxy

Barry SiegelSVP General CounselBuchanan Ingersoll & Rooney PC

Rick ShalabySVP Commercial OperationsMerck, PDI, Amarin

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Transformed Specialty Platform(1)

• Specialty sales force, repositioned and geographically optimized – 100 territories

• Priority is highest ROI, chronic products– Treximet, Silenor

• Legacy business of primary care and generic products supports infrastructure and provides operating leverage

• Significant business development opportunities in CNS and adjacent TAs

CNS franchise is a platform for business development

(1) Chart reflects net revenue mix for 2015E

Treximet

Silenor

Other

Page 10: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.
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Large market opportunity

• Treximet has 2% market share by volume

• Sensitive to promotion, not promoted since 2012

• Serves an unmet need in migraine abortive therapy— provides superior pain relief vs. placebo and vs. sumatriptan and naproxen components alone

• First-ever pediatric extension for adolescents submitted to FDA in November 2014

Commercial execution

• 100 specialty reps selling Treximet in 1st detail position

• Focus on neurology and high-prescribing primary care audiences

• Price realignment effective September 2nd

• Maintaining managed care coverage with no material changes to date

• Co-pay coupon and coverage assistance programs in place

• Positive initial response from physicians

Treximet AcquisitionTotal acquisition price of $252m financed with $220m debt and $32m cash

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• Fixed dose combination (85mg sumatriptan / 500mg naproxen)– Launched by GSK in 2008– Bilayer tablet developed by POZEN with dual MOA– Superior efficacy vs. component parts (faster onset of action, longer

duration of pain relief)

• Attractive label– Acute treatment of migraine attacks with or without aura in adults– Once-daily oral dosing

• 4 Orange Book patents: 3 expire Aug. 2017; 1 expires Oct. 2025– Anticipated pediatric exclusivity through Feb. 2018– Opportunities for life cycle management post-LOE

Treximet Overview

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Re-Launch Underway

October-1

3

November-1

3

December-1

3

January-14

Febru

ary-14

March

-14

April-14

May-1

4

June-14

July-14

August-14

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4$0.0

$5,000,000.0

$10,000,000.0

$15,000,000.0

$20,000,000.0

$25,000,000.0

Monthly Retail Sales(1) ($ MM)

Pernix sales from Sept 2014

• No promotion since January 2013• Customer feedback:

– Physicians thought Treximet had been discontinued

– Pleased that “Treximet is back”– Samples and access are priority

• Pricing realigned with competing brands• Samples distributed starting November • Focus on commercial payers

1) Source: Symphony Health Source Pharmaceutical Audit Suite (PHAST).

Page 14: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.

A Good Day Starts at Night

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• Monthly NRx’s up 49% and TRx’s up 41% since promotion began in May• Consumer awareness is a priority in 2015

– Non-personal HCP and Consumer promotion beginning January 1st

• 100 sales professionals, 2nd detail position• Managed care access has added an additional 58+ million lives that now have

coverage for Silenor; expect to add 1.6 million additional lives on Jan 1, 2015• Little competitive promotion and sampling

– Silenor can dominate share of voice and can be sampled as non-scheduled– Many patients fear current treatment options more than their insomnia

SilenorA Good Day Starts at Night

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Large market opportunity

• Silenor is the only non-controlled prescription sleep medication for people who have trouble staying asleep (the most common type of insomnia)

• Minimal competitive promotion and sampling

• Silenor will dominate share of voice within targeted specialty audience

• Majority of patents with insomnia are not treated with a Rx

• Issues with current prescription sleep aids

• Minimal sales force promotion of Silenor since 2011

Commercial execution

• Significant revenue growth potential through increased ethical promotion

• Expansion of Silenor communications to consumers

• Social media and public relations focus in 2015

• 9 Orange Book patents

• No generics expected until 2020

• 58 million covered lives recently added

• Market access programs initiated

SilenorRe-launched mid-2014

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1,000

1,200

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1,600

1,800

2,000

2,200

Silenor Progress (weekly Rx)

Re-launch with original sales

force alignment

Silenor New Campaign & Sales Force Expansion

Source: Symphony Health Source Pharmaceutical Audit Suite (PHAST)

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Silenor Prescription Trends

2,000

2,500

3,000

3,500

4,000

4,500

5,000

October-

13

November-

13

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January

-14

Febru

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March-14

April-14

May-14

June-14

July-14

August-

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Septem

ber-14

October-

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3,000

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NRx TRx

• Prescriber base is widening• New Rx up 49% since April 2014; Weekly TRx up 41%

Silenor Unique Prescribers Silenor Monthly Prescriptions

Source: Symphony Health Source Pharmaceutical Audit Suite (PHAST)

Page 19: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.

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• FDA guidance provides a clear path forward for OTC Silenor – 3 years to NDA submission– 15 month FDA review

• Reasonable OTC development costs of $10mm-15mm – Label comprehension study– Transient Study – healthy subjects– Actual use study

• Plan to partner commercial OTC launch

Silenor OTC Development

Page 20: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.

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Study Status Timelines

Treximet Adolescent sNDA submitted November 2014 Approximately 6 months

Treximet Alternate DoseCRO agreements executed; Protocol in final stages of development

Begin enrollment 2Q 2015

Silenor Arousability Study site selected; Protocol finalized

Begin enrollment in January 2015

Silenor OTC program Protocol and strategy in development stage

Request for FDA meeting 1Q 2015Plan to file IND in 2015

Development Pipeline

Page 21: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.

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Business Development StrategyLeverage Commercial

Infrastructure• Leverage 100-person specialty sales force• US products/assets in complementary therapeutic areas

Chronic vs. Acute • Preference for chronic-use / refill products• De-emphasis on acute / single-use products

Patient Compliance • Preference for compliant patient populations (e.g. women’s health)• Direct pharmacy to improve patient contact and follow-up

Pricing Power / Reimbursement

• Products that serve an unmet need• Patient-types or products with price robustness

Franchise Depth • 505(b)2 and novel development programs with long exclusivities• Driving towards innovation, late-stage development

Page 22: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.

Financials

Page 23: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.

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Balance Sheet and Capitalization(in millions) June 30, 2014 September 30, 2014

Balance SheetCash $60.8 $16.4

Debt $78.1 $303.8

CapitalizationWeighted Average Basic shares outstanding 37.8 38.2

Fully-diluted shares outstanding(1) 58.4 58.2

(1) Reflects diluted share count at the end of each period, including dilutive impact of convertible debt, in-the-money outstanding options and warrants, and non-vested restricted stock.

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Financial Guidance

(in millions) 2014E 4Q 2014E Implied

2015E

Revenue $110-120 $42 - $52 $230

Adjusted EBITDA $22-24 $21 - $23 $95

Page 25: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.

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Summary

Page 26: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.

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Significant Organic Growth OpportunitiesLarge Market Opportunities Enhanced Promotion Managed Care &

Pharmacy Initiatives Focus on Innovation

• 2013 triptan sales of $4.7 billion– Treximet has 2%

share by volume

• Treximet pediatric sNDA submitted Nov 2014– Migraine has 8% -

23% prevalence in children 11 or older

• 70 million adults in the U.S. affected by insomnia – Silenor has 0.2%

share by volume

• Promotion-sensitive brands (Treximet, Silenor, Cedax)

• Expanded specialty sales force to cover 97% of business

• Re-launched Silenor in May 2014

• Interim launch of Treximet in September 2014– Full re-launch in 1Q

2015

• Managed care initiatives to expand access to key brands and maintain unrestricted coverage– Maintained 140+

million coverage lives for Treximet with no material changes post-transition

– Added 58+ million coverage lives for Silenor

• Pharmacy programs in place to prevent denials, rejections or switches

• Treximet pediatric sNDA submitted

• Other key studies to begin in 2015:– Treximet alternative

dose– Silenor Arousability– Silenor OTC

Page 27: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.

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Achievements and Milestones Refocused organization on specialty markets Built industry-leading team Improved base business profitability Launched Khedezla April 2014 Re-launched Silenor May 2014 Re-launched Treximet September 2014 EBITDA positive 3Q14• Silenor OTC development initiation• Treximet alternate dose development start• Further acquisitions of complementary growth products

Page 28: (1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue.

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Contact information

Pernix Therapeutics10 North Park Place, Suite 201Morristown, NJ 07960

Investor Relations Contact:Sanjay PatelChief Financial Officer(800) [email protected]