Form 8-K PERNIX THERAPEUTICS HOLD For: Nov 10
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
�Pursuant to Section�13 or 15(d) of the Securities Exchange Act of 1934
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Date of Report (Date of earliest event reported): November 10, 2014
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PERNIX THERAPEUTICS HOLDINGS, INC.
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(Exact name of registrant as specified in its charter)
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Maryland
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001-14494
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33-0724736
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(State or other jurisdiction
�of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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10 North Park Place, Suite 201
Morristown, New Jersey
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07960
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code: (800) 793-2145
�(Former name or former address, if changed since last report.)
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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:
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Written communications pursuant to Rule�425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule�14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule�14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule�13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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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.
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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.
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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.
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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.
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Description
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99.1
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Press release, dated November 10, 2014.
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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.
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� PERNIX THERAPEUTICS HOLDINGS, INC.
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Dated:��November�10, 2014�������
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By:
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/s/�Sanjay S. Patel
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Sanjay S. Patel
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Chief Financial Officer
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EXHIBIT INDEX
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Exhibit 99.1
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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
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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.
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Financial Highlights
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Third Quarter net revenues of $31.5 million, an increase of 72% year-over-year, following the launch of TREXIMET� at the beginning of September
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Excluding TREXIMET, discontinued and divested products, net sales increased 20% year-over-year
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Gross margins of 62.9% vs. 47.7% in the third quarter of 2013
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Adjusted EBITDA of $6.9 million vs.��($2.0) million in the third quarter of 2013
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Cash and cash equivalents of $16.4 million
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Filed $300 million shelf registration statement and $100 million at-the-market offering program�to provide financial flexibility and the ability to opportunistically access the capital markets
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Business Highlights
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Completed the acquisition of TREXIMET
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Realigned sales force and executed staged re-launch of TREXIMET
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SILENOR� weekly TRxs up more than 30% since promotion began in May 2014
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Engaged contract sales team to promote Cedax during cough and cold season
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Continuing to evaluate and pursue business development opportunities in complementary specialty areas
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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.
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Financial Update - Third Quarter ending September 30, 2014
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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.
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Net sales of TREXIMET�for the third quarter and year-to-date period of 2014 were $16.3 million, including some restocking within the wholesale and retail channels.
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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.
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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.
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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.
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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.
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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.
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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.
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Financial Results Year-to-Date Period ending September 30, 2014
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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.
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Adjusted EBITDA was $1.0 million compared to ($7.3) million during the prior-year period, an increase of $8.3 million.
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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.
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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.
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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.
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2014 and 2015 Full-Year Guidance
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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
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Pernix will hold a conference call for investors today, November 10th, beginning at 10:00am/U.S. Eastern Time.
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To participate in the conference call:
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Please dial (877) 312-8783 (domestic) or (408) 940-3874 (international).
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Participants can reference the passcode 14525070.
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Please dial in approximately 15 minutes prior to the call.
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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.
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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.
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About Pernix Therapeutics
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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.��
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To learn more about Pernix Therapeutics, visit�www.pernixtx.com.
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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.
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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.
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Pernix Therapeutics Holdings Inc.
Investor Relations
Sanjay Patel, (800) 793-2145 ext. 1009
Chief Financial Officer
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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
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PERNIX THERAPEUTICS HOLDINGS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS (in thousands, except per share data)
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September�30,
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December�31,
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2014
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2013
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(unaudited)
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ASSETS
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Current assets:
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���Cash and cash equivalents
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� | $ | 16,429 | � | � | $ | 15,647 | � |
���Accounts receivable, net
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� | � | 51,844 | � | � | � | 25,681 | � |
���Inventory, net
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� | � | 11,592 | � | � | � | 13,810 | � |
���Note receivable, net of unamortized discount of $172 and $101, respectively
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� | � | 4,675 | � | � | � | 4,749 | � |
���Prepaid expenses and other current assets
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� | � | 10,512 | � | � | � | 5,879 | � |
���Income tax receivable
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� | � | 5,403 | � | � | � | 1,318 | � |
���Deferred income taxes
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� | � | 12,152 | � | � | � | 9,301 | � |
Total current assets
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� | � | 112,607 | � | � | � | 76,385 | � |
Property and equipment, net
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� | � | 1,066 | � | � | � | 6,872 | � |
Other assets:
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���Goodwill
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� | � | 45,890 | � | � | � | 42,497 | � |
���Intangible assets, net
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� | � | 319,139 | � | � | � | 80,022 | � |
���Note receivable, net of unamortized discount of $0 and $319, respectively
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