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Form 8-K PERNIX THERAPEUTICS HOLD For: Nov 10

November 10, 2014 5:02 PM EST


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
�Pursuant to Section�13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 10, 2014
PERNIX THERAPEUTICS HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
Maryland
001-14494
33-0724736
(State or other jurisdiction
�of incorporation)
(Commission File Number)
(IRS Employer Identification No.)

10 North Park Place, Suite 201
Morristown, New Jersey
07960
(Address of principal executive offices)
(Zip Code)
Registrants telephone number, including area code: (800) 793-2145
�(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o
Written communications pursuant to Rule�425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule�14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule�14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule�13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))




Item 2.02 Results of Operations and Financial Condition

On November 10, 2014, Pernix Therapeutics Holdings, Inc. (Pernix) issued a press release announcing its financial results for the third quarter ended September 30, 2014. A copy of the press release is attached hereto as Exhibit 99.1.
The information provided in the Item 2.02, including Exhibit 99.1, is intended to be furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Pernix is also disclosing that it may use the pernixtx.com website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.
Forward-Looking Statements

Certain statements in this Current Report on Form 8-K, including but not limited to statements set forth in the attached press release, may constitute forward-looking statements.� These forward looking statements involve a number of known and unknown risks, uncertainties and other factors that may cause such forward-looking statements not to be realized and that could cause actual results to differ materially from Pernixs expectations in these statements. For more information about other risks that could affect the forward-looking statements herein, please see Pernixs most recent quarterly report on Form 10-Q, annual report on Form 10-K and other filings made with the Securities and Exchange Commission. Pernix expressly disclaims any obligation to release publicly any updates or revisions to any forward-looking statements to reflect any changes in expectations, or any change in events or circumstances on which those statements are based, unless otherwise required by law.

Item 9.01 Financial Statements and Exhibits

�(c) Exhibits


Exhibit No.
Description
99.1
Press release, dated November 10, 2014.

2

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
PERNIX THERAPEUTICS HOLDINGS, INC.
Dated:��November�10, 2014�������
By:
/s/�Sanjay S. Patel
Sanjay S. Patel
Chief Financial Officer


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EXHIBIT INDEX
Exhibit No.
Description
99.1
Press release, dated November 10, 2014.

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Exhibit 99.1
Pernix Therapeutics Reports Third Quarter 2014 Financial Results and Reaffirms Guidance

Third Quarter net revenues increased 72% year-over-year, following the launch of TREXIMET
Company Reiterates Full Year 2014 and 2015 Guidance
Conference Call and Webcast Today, November 10th, beginning at 10:00am EST
MORRISTOWN, NJ -- (BUSINESS WIRE) -- November 10, 2014 -- Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX) today reported financial results for the third quarter and year-to-date periods ending September 30, 2014, and reaffirmed full-year guidance for 2014 and 2015.
Financial Highlights

Ϡ�
Third Quarter net revenues of $31.5 million, an increase of 72% year-over-year, following the launch of TREXIMETat the beginning of September
Ϡ�
Excluding TREXIMET, discontinued and divested products, net sales increased 20% year-over-year
Ϡ�
Gross margins of 62.9% vs. 47.7% in the third quarter of 2013
Ϡ�
Adjusted EBITDA of $6.9 million vs.��($2.0) million in the third quarter of 2013
Ϡ�
Cash and cash equivalents of $16.4 million
Ϡ�
Filed $300 million shelf registration statement and $100 million at-the-market offering programto provide financial flexibility and the ability to opportunistically access the capital markets
Business Highlights
Ϡ�
Completed the acquisition of TREXIMET
Ϡ�
Realigned sales force and executed staged re-launch of TREXIMET
Ϡ�
SILENOR weekly TRxs up more than 30% since promotion began in May 2014
Ϡ�
Engaged contract sales team to promote Cedax during cough and cold season
Ϡ�
Continuing to evaluate and pursue business development opportunities in complementary specialty areas
This has been a strong quarter in which we have seen significant growth, said Doug Drysdale, Chairman, President and Chief Executive Officer. This performance is being driven by the strength of our Specialty Brands, TREXIMET and SILENOR, as well as improving costs from our on-going restructuring initiatives, leading to meaningful top-line and bottom-line growth.
Financial Update - Third Quarter ending September 30, 2014
Net sales were $31.5 million for the third quarter of 2014 compared with $18.3 million reported in the third quarter of 2013, an increase of 72%. Strong net sales were driven by sales of TREXIMET, acquired in August 2014 and re-launched September 2, 2014; growth of SILENOR and continued performance in the Companys base portfolio.
Net sales of TREXIMETfor the third quarter and year-to-date period of 2014 were $16.3 million, including some restocking within the wholesale and retail channels.
Net sales of our product portfolio excluding TREXIMET, including SILENOR, our seasonal/cough & cold products, CEDAX, ZUTRIPRO, VITUZ and REZIRA, as well as our portfolio of generic products through Macoven Pharmaceuticals and Cypress Pharmaceuticals for the third quarter of 2014 were $14.2 million compared with $17.1 million in the prior-year period. Increased sales from TREXIMET and SILENOR were partially offset by the discontinuation of a number of generic products in 2013, as well as the sale of profitable Cypress generic products in September 2013. Excluding TREXIMET and the discontinued and divested products, net sales increased by 20% year-over-year.
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Adjusted EBITDA increased to $6.9 million, compared to ($2.0) million for the same period last year.
Reported GAAP net loss increased from ($5.8) million to ($11.7) million, or ($0.16) to ($0.31) per basic and diluted share, respectively reflecting $8.2 million, or $0.22 per basic and diluted share, of amortization associated with the acquisition of TREXIMET intellectual property.
On a non-GAAP basis, adjusted net loss for the third quarter of 2014 was ($0.9) million, compared with ($2.4) million a year ago. Non-GAAP adjusted diluted loss per share was ($0.02) versus ($0.07) in Q3 2013.
Gross profit increased 127% to $19.8 million for the third quarter of 2014, compared with $8.7 million in the prior-year period, driven by the inclusion and performance of TREXIMET. Gross profit, as a percentage of net sales, was 62.9% for the quarter, versus 47.7% in the prior-year period.
Selling, general and administrative (SG&A) expenses for the third quarter of 2014 were $15.0 million, compared with $11.7 million in the same period in 2013, an increase of 28% versus previous year. However, SG&A expenses as a percentage of net sales were 48% in the third quarter of 2014, compared with 64% in the prior year. The overall increase in SG&A includes the addition of marketing and selling expenses for TREXIMET and SILENOR.��Excluding amortization and marketing, operating expense for the quarter was down 12% year-over-year.
R&D expenses for the third quarter of 2014 were $0.3 million, compared with $0.6 million in the prior-year period, reflecting further development of OTIC and Hylira, as well as life-cycle management of SILENOR, the SILENOR OTC development programs and commencement of TREXIMET life-cycle management initiatives.
Financial Results  Year-to-Date Period ending September 30, 2014
In the first nine months of fiscal 2014, net sales were $67.9 million, compared with $60.9 million in the first nine months of the prior year, representing an 11.4% increase. Increased sales from TREXIMET and SILENOR were partially offset by the discontinuation of a number of generic products in 2013, as well as the sale of profitable Cypress generic products in September 2013.
Adjusted EBITDA was $1.0 million compared to ($7.3) million during the prior-year period, an increase of $8.3 million.
On a non-GAAP basis, adjusted net loss was ($6.8) million, compared with ($9.5) million last year. Non-GAAP adjusted diluted loss per share were ($0.18), compared with ($0.26) last year. This was attributable to benefits from strategic pricing initiatives, the inclusion and performance of TREXIMET and lower tax provision expense.
On a GAAP basis, net loss for the year-to-date period of 2014 was ($27.5) million, compared with ($19.4) million for the same period in 2013. GAAP diluted loss per share was ($0.73), compared with ($0.54) last year, reflecting $8.2 million, or $0.22 per basic and diluted share, of amortization associated with the acquisition of TREXIMET intellectual property.
Net sales of our product portfolio excluding TREXIMET, including SILENOR, our seasonal/cough & cold products, CEDAX, ZUTRIPRO, VITUZ and REZIRA, as well as our portfolio of generic products through Macoven Pharmaceuticals and Cypress Pharmaceuticals for the year-to-date ending September 30, 2014 were $48.2 million compared with $56.0 million in the prior-year period.
2014 and 2015 Full-Year Guidance
Today the Company reaffirms its financial guidance for 2014 and 2015.��With the addition of TREXIMET, Pernix estimates FY 2014 revenue to be in the range of $110 million to $120 million with Adjusted EBITDA of $22 million to $24 million. Pernix estimates FY 2015 revenue will be approximately $230 million with Adjusted EBITDA of approximately $95 million.
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CONFERENCE CALL AND WEBCAST
Pernix will hold a conference call for investors today, November 10th, beginning at 10:00am/U.S. Eastern Time.
To participate in the conference call:
Ϡ�
Please dial (877) 312-8783 (domestic) or (408) 940-3874 (international).
Ϡ�
Participants can reference the passcode 14525070.
Please dial in approximately 15 minutes prior to the call.
The conference call will also be available via a live listen-only webcast and can be accessed through the Investor Relations section of www.pernixtx.com. The passcode is 14525070.� Please allow extra time prior to the call to visit the Pernix website and download any software that may be needed to listen to the webcast.
A replay of the conference call will be available through November 17, 2014, at (855) 859-2056 domestic and (404) 537-3406 international.� The passcode for the replay is 14525070. An online archive of the webcast will be available on the Pernix website for 30 days following the call.
About Pernix Therapeutics
Pernix Therapeutics is a specialty pharmaceutical business�with a focus on acquiring, developing and commercializing prescription drugs primarily for the U.S. market. The Company targets underserved therapeutic areas such as CNS, including neurology and psychiatry, and has an interest in expanding into additional specialty segments.��The Company promotes its branded products to physicians through its Pernix sales force, uses contracted sales organizations to market its non-core, cough and cold products, and markets its generic portfolio through its wholly owned subsidiaries, Macoven Pharmaceutical, LLC and Cypress Pharmaceuticals, Inc.��
To learn more about Pernix Therapeutics, visit�www.pernixtx.com.
Non-GAAP Financial Measures

Pernix is disclosing non-GAAP financial measures in this press release. Primarily due to acquisitions, Pernix believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with U.S. generally accepted accounting principles (GAAP). In addition to disclosing its financial results determined in accordance with GAAP, Pernix is disclosing non-GAAP results that exclude items such as amortization expense and certain other expense and revenue items in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance. Whenever Pernix uses a non-GAAP measure, it will provide a reconciliation of non-GAAP financial measures to the most closely applicable GAAP financial measure. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures set forth herein and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP.

3

Cautionary Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.��Statements including words such as estimate, plan, project, forecast, intend, expect, anticipate, believe, seek, target or similar expressions are forward-looking statements.��Because these statements reflect the Companys current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect the Companys future financial results and could cause actual results to differ materially from those expressed in forward-looking statements contained in the Companys Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Pernix Therapeutics Holdings Inc.
Investor Relations
Sanjay Patel, (800) 793-2145 ext. 1009
Chief Financial Officer
- or -
Doug Drysdale, (800) 793-2145 ext. 1001
Chairman, President and Chief Executive Officer

Media Relations
Marianne Lambertson, (800) 793-2145 ext. 1012
Vice President, Marketing and Corporate Communications

4

PERNIX THERAPEUTICS HOLDINGS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS (in thousands, except per share data)
September�30,
December�31,
2014
2013
(unaudited)
ASSETS
Current assets:
���Cash and cash equivalents
$ 16,429 $ 15,647
���Accounts receivable, net
51,844 25,681
���Inventory, net
11,592 13,810
���Note receivable, net of unamortized discount of $172 and $101, respectively
4,675 4,749
���Prepaid expenses and other current assets
10,512 5,879
���Income tax receivable
5,403 1,318
���Deferred income taxes
12,152 9,301
Total current assets
112,607 76,385
Property and equipment, net
1,066 6,872
Other assets:
���Goodwill
45,890 42,497
���Intangible assets, net
319,139 80,022
���Note receivable, net of unamortized discount of $0 and $319, respectively
4,531
���Other long-term assets
11,490 1,079
Total assets
$ 490,192 $ 211,386
LIABILITIES
Current liabilities:
���Accounts payable
$ 9,507 $ 3,444
���Accrued personnel expenses
2,715 3,803
���Accrued allowances
45,082 34,286
���Other accrued expenses
10,428 5,533
���Contingent consideration  Cypress acquisition
1,330
���Other liabilities
5,327 4,072
���Debt
18,782 17,000
Total current liabilities
91,841 69,468
Long-term liabilities:
���Other liabilities
11,390 14,386
���Debt
1,310
���Senior convertible notes
65,000
���Senior secured notes  TREXIMET
220,000
���Deferred income taxes
13,006 15,499
Total liabilities
401,237 100,663
Commitments and contingencies
STOCKHOLDERS EQUITY
Common stock, $.01 par value, 90,000 shares authorized, 40,623 and 39,318 issued and 38,204 and 37,189 outstanding at September 30, 2014 and December 31, 2013, respectively
382 372
Treasury stock, at cost, 2,419 and 2,129 shares held at September 30, 2014 and December 31, 2013, respectively
(5,075 ) (4,001 )
Additional paid-in capital
126,317 119,554
Accumulated deficit
(32,669 ) (5,202 )
Total stockholders�equity
88,955 110,723
Total liabilities and stockholders equity
$ 490,192 $ 211,386
5

PERNIX THERAPEUTICS HOLDINGS,�INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands, except per share data, unaudited)

Three Months Ended
September 30,
Nine Months Ended
September 30,
2014
2013
2014
2013
Net revenues
$ 31,479 $ 18,295 $ 67,913 $ 60,946
Costs and operating expenses:
����Cost of product sales
11,689 9,572 30,350 33,812
����Selling, general and administrative expenses
15,049 11,740 42,415 38,960
����Research and development expense
290 633 1,604 3,633
��� Depreciation and amortization expense
10,159 2,317 14,319 6,419
����(Gain) / loss on disposal of assets
7 (4 ) 160 1
����(Gain) / loss on sale of PML (including impairment charge)
(13 )
6,659
������� Total costs and operating expenses
37,181 24,258 95,507 82,825
Loss from operations
(5,702 ) (5,963 ) (27,594 ) (21,879 )
Other income (expense):
���Change in fair value of put right
(2,146 )
(6,116 )
���Change in fair value of contingent consideration
522
805
���Interest expense, net
(5,335 ) (783 ) (8,833 ) (3,492 )
���Gain on sale of investment
3,605
��������Total (loss) income, net
(5,335 ) (2,407 ) (8,833 ) (5,198 )
Loss before income taxes
(11,037 ) (8,370 ) (36,427 ) (27,077 )
��� Income tax expense (benefit)
655 (2,547 ) (8,960 ) (7,666 )
Net loss
$ (11,692 ) $ (5,823 ) $ (27,467 ) $ (19,411 )
Other comprehensive income (loss)
��Unrealized gains during the period, net of tax of $411 for the nine
������months ended September 30, 2014
(702 )
��Reclassification adjustment for net realized gain included in net
������loss, net of tax of $1,322 for the nine months ended September 30, 2014
(2,273 )
Comprehensive loss
$ (11,692 ) $ (5,823 ) $ (27,467 ) $ (22,386 )
Net loss per share, basic
$ (0.31 ) $ (0.16 ) $ (0.73 ) $ (0.54 )
Net loss per share, diluted
$ (0.31 ) $ (0.16 ) $ (0.73 ) $ (0.54 )
Weighted-average common shares, basic
38,121 37,121 37,743 36,204
Weighted-average common shares, diluted
38,121 37,121 37,743 36,204
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Supplemental Financial Information
The following table presents a reconciliation of Pernixs net loss to adjusted EBITDA.��The Company defines EBITDA as net income plus interest, income tax expense, depreciation and amortization and presents these measures to assist investors in evaluating Pernixs operating performance and comparing the Companys results with those of other companies.��Adjusted EBITDA should not be considered in isolation from or as a substitute for net income.

PERNIX THERAPEUTICS HOLDINGS, INC.
GAAP Net Loss to Adjusted EBITDA Reconciliation Table
(in thousands, except per share data, unaudited)

Three Months Ended
September 30,
Nine Months Ended
September 30,
2014
2013
2014
2013
GAAP net loss
$ (11,692 ) $ (5,823 ) $ (27,467 ) $ (19,411 )
Depreciation and amortization
10,159 2,317 14,319 6,419
Interest expense, net
5,335 783 8,833 3,492
Income tax expense (benefit)
655 (2,547 ) (8,960 ) (7,666 )�
EBITDA
4,457 (5,270 ) (13,275 ) (17,166 )
One-time contract termination fee
745
745
Increase in basis of acquired inventory included in COGS
194 412 2,591 5,123
Deal expenses
532 576 1,005 1,104
Stock compensation
878 491 3,398 1,516
Stock compensation - ParaPRO
131 (1,175 ) 426
Severance expenses
111
877
(Gain) / loss on disposal of assets
7 (4 ) 160 1
(Gain) / loss on sale of PML (including
����impairment charge)
(13 )�
6,659
Change in fair value of put right
2,146
6,116
Change in fair value of contingent consideration
(522 )
(805 )
Gain on sale of investment
(3,605 )�
Adjusted EBITDA
$ 6,911 $ (2,040 ) $ 985 $ (7,290 )


7

The following table presents a reconciliation of Pernixs net loss to adjusted net income / (loss).��The Company defines adjusted net income / (loss) as net income / (loss) reflecting adjustments for stock-based compensation, amortization of product rights, interest related to convertible securities, one-time contract termination fees, transaction-related expenses, severance expenses, impairment of assets held for sale, acquisition adjustments related to inventory sold, changes in fair value of acquisition-related payments and put rights, gain on the sale of investments, the gain or loss on the divestiture of certain assets and the related tax impacts and presents these measures to assist investors in evaluating Pernixs operating performance and comparing the Companys results with those of other companies.��Adjusted net income / (loss) should not be considered in isolation from or as a substitute for net income.

PERNIX THERAPEUTICS HOLDINGS, INC.
GAAP Net Loss to Adjusted Net Income Reconciliation Table
(in thousands, except per share data, unaudited)

Three Months Ended
September 30,
Nine Months Ended
September 30,
2014
2013
2014
2013
GAAP net loss
$ (11,692 ) $ (5,823 ) $ (27,467 ) $ (19,411 )
Amortization expense
10,107 2,136 14,057 5,931
Interest related to convertible securities
1,300
1,300
One-time contract termination fee
745
745
Increase in basis of acquired inventory included in COGS
194 412 2,591 5,123
Deal expenses
532 576 1,005 1,104
Stock compensation
878 491 3,398 1,516
Stock compensation - ParaPRO
131 (1,175 ) 426
Severance expenses
111
877
Impairment of assets held for sale
6,457
(Gain) / loss on sale of PML
(13 )
202
Change in fair value of contingent consideration
(522 )
(805 )
Change in fair value of put right
2,146
6,116
(Gain) / loss on disposal of assets
7 (4 ) 160 1
Gain on sale of investment
(3,605 )
Tax effect related to adjustments
(3,116 )(1) (1,986 )(1) (8,946 )(1) (5,849 )(1)
Adjusted net income / (loss)
$ (947 ) $ (2,443 ) $ (6,796 ) $ (9,453 )
Adjusted net income / (loss) per common share, basic
$ (0.02 ) $ (0.07 ) $ (0.18 ) $ (0.26 )
Adjusted net income / (loss) per common share, dilutive
$ (0.02 ) $ (0.07 ) $ (0.18 ) $ (0.26 )
Weighted average number common shares outstanding
38,121 37,121 37,743 36,204
Weighted average number common shares outstanding
����assuming dilution
38,121 37,121 37,743 36,204

(1)The tax effect related to adjustments includes the tax effect of the associated pre-tax amounts, calculated by determining the jurisdictional location of the pre-tax amounts and applying that jurisdictions applicable tax rate.
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