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Brand & Generic Business Units Drive Strong Earnings
WOODCLIFF LAKE, N.J., Aug. 4 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. (NYSE:PRX) today reported results for the second quarter ended June 27, 2009.
For the second quarter ended June 27, 2009, Par reported total revenues of $404.0 million and net income of $23.8 million, or $0.71 per diluted share, which included a one-time gain related to the acquisition of certain assets of MDRNA's Hauppauge, NY facility. Adjusting for this item, earnings per diluted share were $0.65 for the three month period ended June 27, 2009. This is compared to reported revenues of $112.9 million and a net loss of $21.2 million, or $0.64 loss per diluted share for the same period in 2008, which included a one-time development milestone payment to a partner. Adjusting for this item, loss per diluted share was $0.61 for the three month period ended June 28, 2008.
For the six months ended June 27, 2009, total revenue was $608.0 million with net income of $39.9 million, or $1.18 per diluted share. This is compared to total revenues of $267.9 million and a net loss of $19.8 million, or $0.60 per diluted share in the same period of 2008.
Second Quarter Highlights
Key Product Sales (Net sales comparisons at the product level are to first quarter 2009)
-- Metoprolol: For the quarter ended June 27, 2009, net sales of
metoprolol succinate reached $306 million, an increase of 173% from
the first quarter 2009. The increase was driven by market exclusivity
and additional product supply which led to increased volume and price.
Par remained the exclusive supplier of metoprolol succinate through
the second quarter. Par is the authorized generic for all strengths
of AstraZeneca's Toprol XL.
-- Sumatriptan: Net sales of sumatriptan injection were $21.8 million for
the quarter ended June 27, 2009 compared to $16.0 million in the first
quarter. The increase was principally due to trade buying patterns,
which included the release of backorders. Par remained the exclusive
supplier of generic Imitrex 4mg and 6mg starter kits and 4mg
prefilled cartridges and had one competitor in the 6mg prefilled
cartridges throughout the second quarter.
-- Meclizine: Net sales for the three months ended June 27, 2009 were
$8.9 million compared to $9.8 million in the first quarter of 2009.
The decrease was due primarily to trade buying patterns. Par was the
exclusive supplier of meclizine in the first half of 2009.
-- Dronabinol: Net sales for the second quarter 2009 were $5.5 million
compared to $7.0 million in the first quarter. The decrease was due
to competitive pricing pressures.
-- Other generic products: For the second quarter 2009, net sales from
all other generic products were $39.6 million compared to $43.0
million in the first quarter. The decrease primarily reflects the
discontinuation of fluticasone and a decline in volume and price of
certain products, including ibuprofen, due to continued competition in
the market, tempered by an increase in volume of certain products such
as tramadol APAP and fluoxetine HCl, as well as the launch of
risperidone ODT in June 2009.
-- Megace ES: Net sales were $17.1 million for the three months ended
June 27, 2009 compared to $13.5 million in the first quarter. The
increase in net sales was due to the increase in prescription demand
and the return to normal trade buying patterns.
-- Nascobal B12 Nasal Spray: Net sales were $2.2 million for the three
months ended June 27, 2009. Strativa Pharmaceutical purchased
Nascobal from QOL Medical, LLC on March 31, 2009 and re-launched the
product on June 15, 2009.
Total net revenues for the three months ended June 27, 2009, were $404 million, up $291 million, or nearly 258%, from the year ago period, principally driven by the lack of competition in metoprolol succinate and meclizine, as well as the launches of sumatriptan injection and dronabinol in the second half of 2008.
Gross margin for the second quarter 2009 was $86.4 million, or 21.4% of total revenue, an increase of $61.3 million from the comparable period in 2008. Total generic gross margin in the second quarter 2009 was $70.7 million, or 18.5% of total generic revenue, compared to $9.2 million, or 9.9% of total generic revenue in the second quarter 2008. This increase is due primarily to higher sales of metoprolol and meclizine and the launches of sumatriptan and dronabinol. These four products contributed $52.5 million of gross margin, or 15.3% of such generic revenue. Gross margin of all other generic products was approximately $18.2 million, or 46% of other generic revenue. This compares to $5.4 million, or 10.0% of other generic revenue, in the second quarter of 2008. The increase in gross margin percentage was due to the trimming of the generic product line as part of the resizing of Par's generic division in the fourth quarter of 2008. Strativa's gross margin of $15.7 million, or 72% of total Strativa revenue, decreased compared to the second quarter of 2008 due to lower sales of Megace ES.
Research and development (R&D) expenses decreased 63% to $5.9 million in the second quarter of 2009 compared to the second quarter 2008 due primarily to the resizing of the generic division, which included a headcount reduction and lower development and biostudy costs.
Selling, general and administrative (SG&A) expenses for the second quarter 2009 increased to $44.1 million compared to $36.7 million in the second quarter 2008. The increase reflects an increase of $6.8 million related to on-going expenditures supporting Strativa sales and marketing, driven primarily by an increase in the field force and other activities in preparation for the re-launch of Nascobal B12 Nasal Spray, as well as development costs of other products.
Cash and cash equivalents and marketable securities aggregate balance as of June 27, 2009, was $202.3 million and reflects significant one-time cash outflows related to the purchase of Nascobal B12 Nasal Spray (approximately $55 million), the year-to-date repurchase of $13.8 million face value of Par's convertible debt at a discount and, as previously reported in the first quarter, the settlement of litigation with Pentech (approximately $66 million).
Face Value of Convertible Debt as of June 27, 2009, was $128.2 million. An additional $35.5 million in convertible debt was repurchased subsequent to the balance sheet date at a discount. The face value of convertible debt currently stands at $92.7 million and matures on September 30, 2010, unless earlier converted or repurchased.
Product and Pipeline Update
Strativa's New Drug Application (NDA) for ondansetron orally dissolving film strip (ODFS) has been accepted by the FDA for review. Pursuant to Prescription Drug User Fee Act (PDUFA), Strativa expects the FDA will complete its review by February 7, 2010. If approved, ondansetron ODFS could launch by mid-2010.
BioAlliance Pharma, Strativa's development partner for miconazole, mucoadhesive bucccal tablets (MBT), which is marketed under the brand name Loramyc in Europe, submitted its NDA to the FDA. Pursuant to PDUFA, BioAlliance expects the FDA will complete its review by second quarter 2010. If approved, Strativa could launch the product in the second half of 2010.
Par successfully launched five strengths of risperidone ODT, a generic version of Risperdal M-TAB, during the second quarter, and was the exclusive supplier of .25mg, 3mg and 4mg strengths of the product during the period. Risperdal M-TAB had $108.0 million in annual sales in 2008 according to IMS Health.
Par also launched calcitonin-salmon nasal spray, the generic version of Miacalcin , during the quarter. Annual U.S. sales of Miacalcin were approximately $104 million in 2008, according to IMS Health.
Par currently has approximately 37 ANDAs pending with the FDA, 14 of which Par believes to be first-to-file and/or first-to-market opportunities with a brand value of approximately $5.9 billion.
Conference Call
Par has scheduled a conference call for Tuesday, August 4 at 9:00 am EDT to discuss results for the second quarter of 2009. Par invites investors and the general public to listen to a webcast of the conference call. Access to the live webcast can be made via the Company's website at http://www.parpharm.com/ and will be available for two weeks. The dial-in number is 866-788-0539 for domestic callers and 857-350-1677 for international callers. The access number is 40463383. A replay of the conference call will be available commencing approximately one hour after the call. The replay dial-in number is 888-286-8010 for domestic callers and 617-801-6888 for international callers. The access number is 95297063.
Non-GAAP Measures
Par believes it prepared its condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP) and pursuant to accounting requirements of the Securities and Exchange Commission applicable to quarterly reports on Form 10-Q. In an effort to provide investors with additional information regarding Par's results and to provide a meaningful period-over-period comparison of Par's financial performance, the Company sometimes uses non-GAAP financial measures as defined by the Securities and Exchange Commission. The differences between the U.S. GAAP and non-GAAP financial measures are reconciled in an attached schedule. In presenting comparable results, the Company discloses non-GAAP financial measures when it believes such measures will be useful to investors in evaluating Par's underlying business performance. Management uses the non-GAAP financial measures to evaluate Par's financial performance against internal budgets and targets. In addition, management internally reviews Par's results excluding the impact of certain items, as it believes that these non-GAAP financial measures are useful for evaluating Par's core operating results and facilitating comparison across reporting periods. Importantly, Par believes non-GAAP financial measures should be considered in addition to, and not in lieu of, U.S. GAAP financial measures. Par's non-GAAP financial measures may be different from non-GAAP financial measures used by other companies.
About Par
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit http://www.parpharm.com/.
Safe Harbor Statement
Certain statements in this news release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2008, in other of the Company's filings with the SEC from time to time, including Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.
PAR PHARMACEUTICAL COMPANIES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Share Data)
(Unaudited)
June 27, December 31,
2009 2008
---- ----
ASSETS
------
Current assets:
Cash and cash equivalents $139,359 $170,629
Available for sale marketable debt and
equity securities 62,980 93,097
Accounts receivable, net 261,950 83,408
Inventories 55,072 42,504
Prepaid expenses and other current
assets 15,581 20,040
Deferred income tax assets 37,474 53,060
Income taxes receivable 22,257 35,397
------ ------
Total current assets 594,673 498,135
Property, plant and equipment, at cost
less accumulated depreciation and
amortization 79,271 79,439
Available for sale marketable debt and
equity securities 1,150 1,949
Intangible assets, net 78,252 35,208
Goodwill 63,729 63,729
Deferred financing costs and other
assets 828 1,159
Non-current deferred income tax assets,
net 67,211 68,618
------ ------
Total assets $885,114 $748,237
======== ========
LIABILITIES AND STOCKHOLDERS' EQUITY
------------------------------------
Current liabilities:
Current portion of long-term debt $- $130,141
Accounts payable 38,622 22,879
Payables due to distribution agreement
partners 177,103 91,451
Accrued salaries and employee benefits 14,550 11,850
Accrued expenses and other current
liabilities 37,466 38,352
------ ------
Total current liabilities 267,741 294,673
Long-term debt, less current portion 120,038 -
Other long-term liabilities 41,259 41,581
Commitments and contingencies - -
Stockholders' equity
Common Stock, par value $0.01 per share,
authorized 90,000,000 shares; issued
37,560,564 and 37,392,469 shares 375 374
Additional paid-in capital 325,173 319,976
Retained earnings 199,360 159,470
Accumulated other comprehensive gain 816 122
Treasury stock, at cost 2,792,963 and
2,716,010 shares (69,648) (67,959)
------- -------
Total stockholders' equity 456,076 411,983
------- -------
Total liabilities and stockholders'
equity $885,114 $748,237
======== ========
PAR PHARMACEUTICAL COMPANIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Per Share Data)
(Unaudited)
Three Months Ended Six Months Ended
------------------ ----------------
June 27, June 28, June 27, June 28,
2009 2008 2009 2008
---- ---- ---- ----
Revenues:
Net product sales $400,149 $108,289 $600,372 $259,526
Other product related
revenues 3,852 4,648 7,664 8,339
----- ----- ----- -----
Total revenues 404,001 112,937 608,036 267,865
Cost of goods sold 317,593 87,829 457,559 193,236
------- ------ ------- -------
Gross margin 86,408 25,108 150,477 74,629
Operating expenses:
Research and development 5,937 15,955 13,109 33,113
Selling, general and
administrative 44,117 36,690 77,077 68,037
Settlements and loss
contingencies, net 61 - (3,315) -
Restructuring costs 81 - 1,482 -
-- - ----- -
Total operating expenses 50,196 52,645 88,353 101,150
------ ------ ------ -------
Gain on sale of product
rights and other 265 500 1,365 2,125
--- --- ----- -----
Operating income (loss) 36,477 (27,037) 63,489 (24,396)
Gain on bargain purchase 3,021 - 3,021 -
Gain on extinguishment of
senior subordinated
convertible notes 504 - 749 -
Equity in loss of joint
venture - (310) - (330)
Loss on marketable
securities and other
investments, net - (433) (55) (433)
Interest income 667 2,129 1,824 5,143
Interest expense (2,595) (3,544) (5,162) (7,054)
------- ------- ------- -------
Income (loss) from
continuing operations
before provision
(benefit) for income
taxes 38,074 (29,195) 63,866 (27,070)
Provision (benefit) for
income taxes 14,087 (8,236) 23,624 (7,495)
------ ------- ------ -------
Income (loss) from
continuing operations 23,987 (20,959) 40,242 (19,575)
Discontinued operations:
Gain from discontinued
operations - - - 505
Provision for income taxes 176 268 352 713
--- --- --- ---
Gain (loss) from
discontinued operations (176) (268) (352) (208)
---- ---- ---- ----
Net income (loss) $23,811 ($21,227) $39,890 ($19,783)
======= ======== ======= ========
Basic earnings (loss) per
share of common stock:
Income (loss) from
continuing operations $0.71 ($0.63) $1.20 ($0.59)
Gain (loss) from
discontinued operations 0.00 (0.01) (0.01) (0.01)
---- ----- ----- -----
Net income (loss) $0.71 ($0.64) $1.19 ($0.60)
===== ======= ===== =======
Diluted earnings (loss)
per share of common stock:
Income (loss) from
continuing operations $0.71 ($0.63) $1.19 ($0.59)
Gain (loss) from
discontinued operations 0.00 (0.01) (0.01) (0.01)
---- ----- ----- -----
Net income (loss) $0.71 ($0.64) $1.18 ($0.60)
===== ======= ===== =======
Weighted average number of
common shares
outstanding:
Basic 33,630 33,304 33,616 33,262
====== ====== ====== ======
Diluted 33,771 33,304 33,772 33,262
====== ====== ====== ======
Reconciliation Between Reported (GAAP) and Adjusted Net Income (Loss)
(In thousands, except per share data)
(Unaudited)
Three Months Ended
------------------
June 27, June 28,
2009 2008
---- ----
Reported Net Income (Loss) $23,811 ($21,227)
Development Milestone Payments - 1,250
Gain on Bargain Purchase (3,021) -
Restructuring Costs 81 -
Estimated Tax on Adjustments 1,094 (475)
----- ----
Adjusted Net Income (Loss) (non-GAAP measure) $21,965 ($20,452)
======= ========
Diluted Earnings (Loss) Per Share:
Reported $0.71 ($0.64)
===== ======
Adjusted (non-GAAP measure) $0.65 ($0.61)
===== ======
Six Months Ended
----------------
June 27, June 28,
2009 2008
---- ----
Reported Net Income (Loss) $39,890 ($19,783)
Change in Estimate Related to Final Pentech
Settlement (3,412) -
Development Milestone Payments 1,000 6,250
Gain on Bargain Purchase (3,021) -
Restructuring Costs 1,482 -
Estimated Tax on Adjustments 1,462 (2,375)
----- ------
Adjusted Net Income (Loss) (non-GAAP measure) $37,401 ($15,908)
======= ========
Diluted Earnings (Loss) Per Share:
Reported $1.18 ($0.60)
===== ======
Adjusted (non-GAAP measure) $1.11 ($0.48)
===== ======
DATASOURCE: Par Pharmaceutical Companies, Inc.
CONTACT: Allison Wey, Senior Director, Investor Relations and Corporate
Affairs of Par Pharmaceutical Companies, Inc., +1-201-802-4000
Web Site: http://www.parpharm.com/