HI TECH PHARMACAL CO INC - FORM 10-Q

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EX-31.1 - RULE 13A-14(A)/15D-14(A) CERTIFICATION - HI TECH PHARMACAL CO INC	d251368dex311.htm
EX-31.2 - RULE 13A-14(A)/15D-14(A) CERTIFICATION - HI TECH PHARMACAL CO INC	d251368dex312.htm
EXCEL - IDEA: XBRL DOCUMENT - HI TECH PHARMACAL CO INC	Financial_Report.xls
EX-32 - CERTIFICATION OF OFFICERS PURSUANT TO 18 U.S.C. SECTION 1350 - HI TECH PHARMACAL CO INC	d251368dex32.htm

United States

Securities and Exchange Commission

Washington, D.C. 20549

Form 10-Q

x	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended October 31, 2011

¨	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number 0-20424

Hi-Tech Pharmacal Co., Inc.

(Exact name of registrant as specified in its charter)

Delaware

11-2638720

(State or other jurisdiction of

incorporation or organization)

(IRS Employer

Identification No.)

369 Bayview Avenue, Amityville, New York 11701

(Address of principal executive offices) (zip code)

631 789-8228

(Registrant’s telephone number including area code)

Not applicable

(Former name, former address and former fiscal year, if changed since last report)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Date File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definition of “accelerated filer”, “large accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.): Yes ¨ No x

Indicate the number of shares outstanding of each of the issuer’s classes of common equity, as of the latest practicable date: Common Stock, $.01 Par Value—12,990,000 shares outstanding as December 5, 2011

INDEX

HI-TECH PHARMACAL CO., INC.


		Page
PART I. FINANCIAL INFORMATION

Item 1.	Financial Statements		3

	Condensed consolidated balance sheets—October 31, 2011 (unaudited) and April 30, 2011		3

	Condensed consolidated statements of operations—Three months and six months ended October 31, 2011 and 2010 (unaudited)		4

	Condensed consolidated statements of cash flows—Six months ended October 31, 2011 and 2010 (unaudited)		5

	Notes to condensed consolidated financial statements (unaudited)		6

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations		13

Item 3.	Quantitative and Qualitative Disclosures About Market Risk		20

Item 4.	Controls and Procedures		21

PART II. OTHER INFORMATION

Item 1.	Legal Proceedings		21

Item 1A.	Risk Factors		21

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds		21

Item 3.	Defaults Upon Senior Securities		21

Item 4.	Reserved		21

Item 5.	Other Information		21

Item 6.	Exhibits		21

	Signatures		22

	Certifications

PART I. ITEM 1.

HI-TECH PHARMACAL CO., INC.

CONDENSED CONSOLIDATED BALANCE SHEETS


	October 31, 2011			April 30, 2011
	(unaudited)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	71,576,000		$	62,304,000
Accounts receivable, less allowance for doubtful accounts		53,701,000			57,632,000
Inventory		32,850,000			23,784,000
Deferred income taxes		6,548,000			5,546,000
Prepaid income taxes		3,046,000			661,000
Other current assets		3,242,000			3,041,000
Current assets of discontinued operations		—			774,000

TOTAL CURRENT ASSETS	$	170,963,000		$	153,742,000
Property and equipment—net		27,384,000			25,866,000
Intangible assets—net		47,364,000			21,231,000
Deferred income taxes		886,000			1,084,000
Other assets		501,000			300,000
Non-current assets of discontinued operations		—			1,017,000

TOTAL ASSETS	$	247,098,000		$	203,240,000

LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable	$	9,217,000		$	7,806,000
Accrued expenses		12,453,000			13,658,000
Current portion of long-term debt		360,000			37,000
Current portion of contingent payment liability		2,674,000			—
Current liabilities of discontinued operations		—			106,000

TOTAL CURRENT LIABILITIES	$	24,704,000		$	21,607,000
Contingent payment liability		9,340,000			—
Long-term debt		1,416,000			621,000

TOTAL LIABILITIES	$	35,460,000		$	22,228,000

Commitments and Contingencies (Note 13)
STOCKHOLDERS’ EQUITY
Preferred stock, par value $.01 per share; authorized 3,000,000 shares, none issued
Common stock, par value $.01 per share; authorized 50,000,000 shares, issued 15,257,000 at October 31, 2011 and 15,163,000 at April 30, 2011, respectively		153,000			152,000
Additional paid-in capital		83,050,000			79,981,000
Retained earnings		151,435,000			123,879,000
Treasury stock, 2,456,000 shares of common stock, at cost on October 31, 2011 and April 30, 2011		(23,000,000	)		(23,000,000	)

TOTAL STOCKHOLDERS’ EQUITY	$	211,638,000		$	181,012,000

LIABILITIES AND STOCKHOLDERS’ EQUITY	$	247,098,000		$	203,240,000

See notes to condensed consolidated financial statements

HI-TECH PHARMACAL CO., INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)


	Three months ended October 31,						Six months ended October 31,
	2011			2010			2011			2010
NET SALES	$	56,875,000		$	44,656,000		$	113,086,000		$	83,965,000
Cost of goods sold		23,479,000			19,525,000			46,454,000			36,291,000

GROSS PROFIT		33,396,000			25,131,000			66,632,000			47,674,000

COST AND EXPENSES:
Selling, general and administrative expenses		11,859,000			8,628,000			21,430,000			17,648,000
Research and product development costs		2,468,000			2,402,000			5,867,000			4,348,000
Royalty income		(829,000	)		(1,177,000	)		(1,395,000	)		(2,221,000	)
Contract research income		(1,000	)		(429,000	)		(28,000	)		(617,000	)
Interest expense		31,000			12,000			46,000			22,000
Interest income and other		(282,000	)		(178,000	)		(306,000	)		(216,000	)

TOTAL		13,246,000			9,258,000			25,614,000			18,964,000

Income from continuing operations before income tax expense		20,150,000			15,873,000			41,018,000			28,710,000
Income tax expense		6,367,000			5,450,000			13,462,000			9,762,000

Income from continuing operations		13,783,000			10,423,000			27,556,000			18,948,000
(Loss) from discontinued operations, net of tax		—			(447,000	)		—			(297,000	)

NET INCOME	$	13,783,000		$	9,976,000		$	27,556,000		$	18,651,000

BASIC INCOME (LOSS) PER SHARE:
Continuing operations		1.08			0.83			2.16			1.50
Discontinued operations		0.00			(0.04	)		0.00			(0.02	)

BASIC INCOME PER SHARE	$	1.08		$	0.79		$	2.16		$	1.48

DILUTED INCOME (LOSS) PER SHARE:
Continuing operations		1.04			0.79			2.08			1.45
Discontinued operations		0.00			(0.03	)		0.00			(0.02	)

DILUTED INCOME PER SHARE	$	1.04		$	0.76		$	2.08		$	1.43

Weighted average common shares outstanding—basic		12,761,000			12,585,000			12,744,000			12,577,000
Effect of potential common shares		543,000			459,000			483,000			477,000

Weighted average common shares outstanding—diluted		13,304,000			13,044,000			13,227,000			13,054,000

See notes to condensed consolidated financial statements

HI-TECH PHARMACAL CO., INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)


	Six months ended October 31,
	2011			2010
NET CASH FLOWS PROVIDED BY OPERATING ACTIVITIES OF CONTINUING OPERATIONS	$	24,328,000		$	11,686,000

NET CASH FLOWS USED IN OPERATING ACTIVITIES OF DISCONTINUED OPERATIONS		—			(458,000	)

CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property, plant and equipment		(3,165,000	)		(3,139,000	)
Proceeds from the sale of intangible assets		1,685,000			156,000
Purchase of intangible assets		(15,958,000	)		(36,000	)
Purchase of ECR Pharmaceuticals assets		(498,000	)		—

NET CASH (USED IN) INVESTING ACTIVITIES OF CONTINUING OPERATIONS		(17,936,000	)		(3,019,000	)

CASH FLOWS FROM FINANCING ACTIVITIES:
Issuance of common stock and exercise of options		1,115,000			295,000
Tax benefits of stock incentives		647,000			145,000
Borrowings from long-term debt		1,155,000			621,000
Payment of borrowings		(37,000	)		(95,000	)

NET CASH PROVIDED BY FINANCING ACTIVITIES OF CONTINUING OPERATIONS		2,880,000			966,000

NET INCREASE IN CASH AND CASH EQUIVALENTS		9,272,000			9,175,000
Cash and cash equivalents at beginning of the period		62,304,000			36,018,000

CASH AND CASH EQUIVALENTS AT END OF PERIOD	$	71,576,000		$	45,193,000

Supplemental disclosures of cash flow information:
Interest paid	$	31,000		$	22,000
Income taxes paid	$	14,000,000		$	11,985,000
Supplemental disclosures of non-cash investing transactions:
Obligation related to purchase of intangible assets included in accrued expenses	$	355,000		$	1,428,000
Contingent payment liability related to purchase of intangible assets	$	11,993,000		$	—

See notes to condensed consolidated financial statements

HI-TECH PHARMACAL CO., INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

October 31, 2011

1. BASIS OF PRESENTATION:

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by US GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. The preparation of the Company’s financial statements in conformity with US GAAP necessarily requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the balance sheet dates and the reported amounts of revenues and expense during the reporting periods. Actual results could differ from these estimates and assumptions. Operating results for the three and six month periods ended October 31, 2011 are not necessarily indicative of the results that may be expected for the year ending April 30, 2012. For further information, refer to the consolidated financial statements and footnotes thereto for the year ended April 30, 2011 in the Company’s Annual Report on Form 10-K.

2. BUSINESS:

Hi-Tech Pharmacal Co., Inc. (“Hi-Tech” or the “Company”, which may be referred to as “we”, “us” or “our”), a Delaware corporation, incorporated in April 1982, is a specialty pharmaceutical company developing, manufacturing and marketing generic and branded prescription and OTC products. The Company specializes in the manufacture of liquid and semi-solid dosage forms and produces a range of sterile ophthalmic, otic and inhalation products. The Company’s Health Care Products Division is a developer and marketer of branded prescription and OTC products for the diabetes marketplace. Hi-Tech’s ECR Pharmaceuticals subsidiary markets branded prescription products.

The following table presents the net sales data for the Company by division:


	Six months ended October 31, 2011		Six months ended October 31, 2010
Hi-Tech Generics	$	97,637,000	$	68,846,000
Health Care Products		8,232,000		6,880,000
ECR Pharmaceuticals		7,217,000		8,239,000

Total	$	113,086,000	$	83,965,000

3. REVENUE RECOGNITION:

Revenue is recognized for product sales upon shipment and passing of title and risk of loss to the customer and when estimates of discounts, rebates, promotional adjustments, price adjustments, returns, chargebacks, and other potential adjustments are reasonably determinable, collection is reasonably assured and the Company has no further performance obligations. These estimates are presented in the financial statements as reductions to net revenues and accounts receivable. Contract research income is recognized as work is completed and as billable costs are incurred. In certain cases, contract research income is based on attainment of designated milestones. Advance payments may be received to fund certain development costs.

Royalty income is related to sales of divested products which are sold by third parties. For those agreements, the Company recognizes revenue based on royalties reported by those third parties and earned during the applicable period.

4. NET INCOME PER SHARE:

Basic income from continuing operations per common share is computed based on the weighted average number of common shares outstanding and on the weighted average number of common shares and share equivalents (stock options) outstanding for diluted earnings from continuing operations per share. The weighted average number of shares outstanding used in the computation of diluted net earnings from continuing operations per share does not include the effect of potentially outstanding common stock whose effect would have been antidilutive. Such outstanding potential shares consisted of options totaling 0 and 288,000 shares for the three months and six months ended October 31, 2011 and October 31, 2010, respectively.

5. INVENTORY:

The components of inventory consist of the following:


	October 31, 2011		April 30, 2011
Finished products	$	13,644,000	$	8,124,000
Work in process		807,000		935,000
Raw materials		18,399,000		14,725,000

Total inventory	$	32,850,000	$	23,784,000

6. PROPERTY AND EQUIPMENT:

The components of property and equipment consist of the following:


	October 31, 2011		April 30, 2011
Land and building and improvements	$	17,959,000	$	17,453,000
Machinery and equipment		29,402,000		26,916,000
Transportation equipment		55,000		55,000
Computer equipment and systems		5,814,000		5,679,000
Furniture and fixtures		1,181,000		1,145,000

	$	54,411,000	$	51,248,000
Accumulated depreciation and amortization		27,027,000		25,382,000

Total property and equipment	$	27,384,000	$	25,866,000

The Company incurred depreciation expense of $1,645,000 and $1,377,000 for the six months ended October 31, 2011 and 2010, respectively. Depreciation expense for the three months ended October 31, 2011 and 2010 was $873,000 and $699,000, respectively. No depreciation is taken on land with a carrying value of $1,754,000 at October 31, 2011 and April 30, 2011.

7. INTANGIBLE ASSETS:

The components of net intangible assets are as follows:


	October 31, 2011		April 30, 2011		Amortization Period
TussiCaps^® intangible asset	$	22,384,000	$	—		3-10 years
ECR intangible assets		5,870,000		6,232,000		9-10 years
MagOx^® intangible assets		3,416,000		3,622,000		10 years
Clobetasol intangible asset		3,400,000		3,600,000		10 years
Atley Pharma intangible asset		3,193,000		—		3-10 years
Zolpimist^® intangible assets		2,719,000		2,906,000		10 years
Zostrix ^® intangible assets		2,395,000		2,616,000		3-11.5 years
KVK License intangible assets		2,000,000		—		10 years
Midlothian intangible assets		728,000		787,000		3-10 years
Vosol^® and Vosol^® HC intangible assets		437,000		473,000		10 years
Other intangible assets		822,000		995,000		2-10 years

Total intangible assets	$	47,364,000	$	21,231,000

Intangible assets are stated at cost, net of amortization using the straight line method over the expected useful lives of the product rights, once the related products begin to sell. Amortization expense of the intangible assets for the six months ended October 31, 2011 and 2010 was $2,175,000 and $1,056,000, respectively. Amortization expense for the three months ended October 31, 2011 and 2010 was $1,400,000 and $524,000, respectively. Amortization is included in selling, general and administrative expenses for all periods presented. The Company tests for impairment of intangible assets annually and when events or circumstances indicate that the carrying value of the assets may not be recoverable. During the six months ended October 31, 2010, the Company determined that the value of Tanafed^®, which is included in other intangible assets, was impaired. The Company wrote down the value of the intangible asset by $221,000. As of October 31, 2011 the Tanafed^® intangible asset was fully amortized.

On June 28, 2011, the Company acquired marketing and distribution rights to several unique branded products for the treatment of pain from Atley Pharmaceuticals. Some products are approved and some are pending approval with the Food and Drug Administration (“FDA”). The Company paid $3,220,000 in cash for rights to the products and inventory. Inventory acquired was valued at $248,000. The Company will pay an additional $355,000 within 180 days, less any amount which has been offset by certain claims. The Company will pay royalties for certain of these products under a license agreement it has assumed. In July 2011, the Company exercised its option to buy out one of the royalty streams related to one of the products for the amount of $500,000, which was paid in August 2011. Such amount has been presented as prepaid royalties.

On July 29, 2011, the Company acquired marketing and distribution rights to an ANDA filing from KVK-Tech, Inc. for dexbrompheniramine maleate 6mg/pseudoephedrine sulfate 120 mg extended release tablets for $2,000,000. Upon approval from the FDA, the product will be marketed by ECR Pharmaceuticals, the Company’s branded sales and marketing subsidiary, under the Lodrane^® brand name.

On August 19, 2011, the Company acquired Tussicaps^® extended-release capsules and some inventory from Mallinckrodt LLC (“Mallinckrodt”). The Company paid $11,600,000 in cash and may make additional payments of up to $12,500,000 over the next four years depending on the competitive landscape and sales performance. The Company has recorded a preliminary contingent liability of $12,014,000, of which $2,674,000 is classified as a current liability. The preliminary liability recorded is subject to a final valuation analysis. The fair value of the contingent payment was estimated using the present value of management’s projection of the expected payments pursuant to the term of the agreement. Inventory acquired was valued at $664,000. Tussicaps^® is covered by a patent which will expire in May 2025. The Company and Mallinckrodt entered into a manufacturing agreement pursuant to which Mallinckrodt will manufacture and supply the Tussicaps^® products to the Company for at least seven years.

8. LONG-TERM DEBT:

The Company entered into a Revolving Credit Agreement, effective as of June 1, 2010, with JPMorgan Chase (the “Revolving Credit Agreement”). The Revolving Credit Agreement permits the Company to borrow up to $10,000,000 pursuant to a revolving credit note (“Revolving Credit Note”) for, among other things within certain sublimits, general corporate purposes, acquisitions, research and development projects and future stock repurchase programs. Loans shall bear interest at a rate equal to, at the Company’s option, in the case of a CB Floating Rate Loan, as defined in the Revolving Credit Agreement, the Prime Rate, as defined in the Revolving Credit Agreement; provided that, the CB Floating Rate shall never be less than the Adjusted One Month LIBOR, or for a LIBOR Loan, at a rate equal to the Adjusted LIBOR plus the Applicable Margin, as such terms are defined in the Revolving Credit Agreement. The Revolving Credit Agreement contains covenants customary for agreements of this type, including covenants relating to a liquidity ratio, a debt service coverage ratio and a minimum consolidated net income. Borrowings under the Revolving Credit Agreement mature on May 27, 2013.

If an event of default under the Revolving Credit Agreement shall occur and be continuing, the commitments under the Revolving Credit Agreement may be terminated and the principal amount outstanding under the Revolving Credit Agreement, together with all accrued unpaid interest and other amounts owing under the Revolving Credit Agreement and related loan documents, may be declared immediately due and payable.

As of October 31, 2011, there were no borrowings under the Revolving Credit Agreement.

The Company entered into a $5,000,000 equipment financing agreement with JPMorgan Chase on June 1, 2010. Loans bear interest at a rate equal to, at the Company’s option, in the case of a CB Floating Rate Loan, as defined in the agreement, the Prime Rate, as defined in the agreement; provided that, the CB Floating Rate shall never be less than the Adjusted One Month LIBOR, or for a LIBOR Loan, at a rate equal to the Adjusted LIBOR plus the Applicable Margin, as such terms are defined in the agreement. On June 15, 2010 the Company drew down $621,000 of the equipment financing line to fund a down payment for new filling and packaging equipment. On October 13, 2011, the Company borrowed an additional $1,155,000 to finance the remaining payments for the equipment. Total borrowings under the equipment financing agreement amount to $1,776,000 as of October 31, 2011. Borrowings under the equipment financing agreement mature on October 6, 2016 and require repayments in the amount of approximately $30,000 per month. In connection with this agreement, the Company has classified $360,000 as current portion of long-term debt.

9. FREIGHT EXPENSE:

Outgoing freight costs amounted to $2,042,000 and $1,638,000 for the six months ended October 31, 2011 and 2010 and are included in selling, general, and administrative expense. Outgoing freight costs amounted to $1,056,000 and $985,000 for the three months ended October 31, 2011 and 2010, respectively. Incoming freight is included in cost of goods sold.

10. STOCK-BASED COMPENSATION:

The Company follows the provisions of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 718, “Compensation—Stock Compensation” (“ASC 718”). ASC 718 requires the measurement and recognition of compensation expense for all share-based payment awards made to employees, non-employee directors, and consultants, including employee stock options. Stock compensation expense based on the grant date fair value estimated in accordance with the provisions of ASC 718 is recognized as an expense over the requisite service period.

For stock options granted as consideration for services rendered by non-employees, the Company recognizes compensation expense in accordance with the requirements of FASB ASC Topic 505-50, “Equity Based Payments to Non-Employees”.

Non-employee option grants that do not vest immediately upon grant are recorded as an expense over the vesting period of the underlying stock options. At the end of each financial reporting period prior to vesting, the value of these options, as calculated using the Black-Scholes option-pricing model, is re-measured using the fair value of the Company’s common stock and the non-cash compensation recognized during the period is adjusted accordingly. Since the fair market value of options granted to non-employees is subject to change in the future, the amount of the future compensation expense includes fair value re-measurements until the stock options are fully vested. During the 6 months ended October 31, 2011 and October 31, 2010 there was no non-employee option outstanding.

The Company’s employee stock options are considered incentive stock options unless they do not meet the requirements for incentive stock options under the Internal Revenue Code. With incentive stock options, there is no tax deferred benefit associated with recording the stock-based compensation.

The Company recognized stock-based compensation for awards issued under the Company’s Stock Option Plans and Employee Stock Purchase Plan in the following line items in the Condensed Statement of Operations:


	Three months ended October 31, 2011		Three months ended October 31, 2010		Six months ended October 31, 2011		Six months ended October 31, 2010
Cost of goods sold	$	87,000	$	36,000	$	174,000	$	126,000
Selling, general and administrative expenses		571,000		415,000		1,137,000		791,000
Research and product development costs		83,000		73,000		166,000		130,000

Stock-based compensation expense	$	741,000	$	524,000	$	1,477,000	$	1,047,000

The Company has elected to use the Black-Scholes option-pricing model, which incorporates various assumptions including volatility, expected life, and interest rate. The expected volatility is based on the historical volatility of the Company’s common stock. The interest rates for periods within the contractual life of the award are based on the U.S. Treasury yield on the date of each option grant.

All options granted through October 31, 2011 had exercise prices equal to the fair market value of the stock on the date of grant, a contractual term of ten years and generally a vesting period of four years. In accordance with ASC Topic 718, the Company adjusts share-based compensation on a quarterly basis for changes to the estimate of expected equity award forfeitures based on actual forfeiture experience. The effect of adjusting the forfeiture rate for all expense amortization after May 1, 2006 is recognized in the period the forfeiture estimate is changed. As of October 31, 2011, the weighted average forfeiture rate was 9% and the effect of forfeiture adjustments for the three and six months ended October 31, 2011 and 2010 was insignificant. The Company did not grant any options during the six months ended October 31, 2011 and 2010.

The intrinsic value of options exercised for the Amended and Restated Stock Option Plan, the 2009 Stock Option Plan and the 1994 Directors Stock Option Plan, as amended was $1,822,000 and $383,000 for the six month periods ended October 31, 2011 and October 31, 2010, respectively. As of October 31, 2011, $6,437,000 of total unrecognized compensation cost related to stock options for both plans is expected to be recognized over a weighted average period of 2.6 years.

11. PRODUCT DIVESTITURES:

On July 3, 2009 the Company entered into an agreement whereby the Company has granted the marketing rights to certain nutritional products previously marketed by our division, Midlothian Laboratories (“Midlothian”), in exchange for a series of payments totaling $1,000,000 over the course of one year. In addition, the Company receives a royalty on the sales of these products, not to exceed $1,500,000 per year for three years ending June 30, 2012. Royalty income earned under this agreement amounted to $685,000 and $855,000 for the six months ended October 31, 2011 and October 31, 2010, respectively. The Company retained this royalty stream when it divested its Midlothian business.

Effective May 1, 2011, the Company divested Midlothian in exchange for a cash payment of $1,700,000. No gain or loss was recognized on the divesture as the Company had recorded an impairment charge of approximately $1,300,000 at April 30, 2011. The

Company retained marketing and distribution rights to generic buprenorphine sublingual tablets, an ANDA that is filed with the FDA, an ANDA that is in development and a royalty stream from products previously divested, as discussed above. Metrics, Inc., a drug development company located in North Carolina, acquired Midlothian from the Company.

The operations of Midlothian have been segregated from continuing operations and are reflected as discontinued operations in the consolidated statement of operations as follows:


	Three months ended October 31, 2010			Six months ended October 31, 2010
Sales	$	234,000		$	1,325,000
Loss from discontinued operations, net of tax	$	(447,000	)	$	(297,000	)
Diluted loss per common share from discontinued operations	$	(0.03	)	$	(0.02	)

12. INCOME TAXES:

The Company estimated its effective tax rate to be approximately 33% for the year ending April 30, 2012. On May 1, 2008, the Company adopted the provisions of ASC Topic 740-10, “Income Taxes” relating to recognition thresholds and measurement attributes for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Company has elected an accounting policy to classify interest and penalties related to unrecognized tax benefits as interest expense. At October 31, 2011 and April 30, 2011, the Company did not have any amount recorded for uncertain tax positions.

In July 2010, the Company paid approximately $160,000 to settle liabilities relating to the examination of the years ended April 30, 2004 and 2005. The Company is no longer subject to U.S. federal, state or local income tax examination for years ended prior to April 30, 2008.

13. CONTINGENCIES AND OTHER MATTERS:

[1] Government regulation:

The Company’s products and facilities are subject to regulation by a number of Federal and State governmental agencies. The Food and Drug Administration (“FDA”), in particular, maintains oversight of the formulation, manufacture, distribution, packaging and labeling of all of the Company’s products. The Drug Enforcement Administration (“DEA”) maintains oversight over the Company’s products that are considered controlled substances.

On June 30, 2010, the Company received a warning letter from the FDA. The warning letter primarily dealt with the marketing of several products that the FDA states require FDA approval and manufacturing practices related to those products. The Company suspended sales of these products as a result of the warning letter. Sales of these products totaled approximately $5,000,000 in fiscal year 2010. In addition, the Company incurred an expense of $534,000 and $865,000 to write off the value of the inventory used in the manufacturing of these products in fiscal year 2011 and fiscal year 2010, respectively. The Company responded to the warning letter and has met with FDA officials to determine how best to resolve these issues. In November, 2010, the Company was the subject of an FDA inspection. The inspection was a follow up to the warning letter received June 30, 2010 as well as a general GMP inspection. The Company received a Form 483, an FDA form on which deficiencies are noted after an FDA inspection, with inspector observations. The Company responded to those observations.

On March 2, 2011, the FDA indicated in its MedWatch publication that the FDA removed approximately 500 currently marketed cough/cold and allergy related products including Lodrane^® products. Three of these were marketed by ECR Pharmaceuticals under the brand name Lodrane^®. ECR Pharmaceuticals stopped shipping these products as of August 31, 2011. Sales of Lodrane^® products amounted to approximately $2,800,000 and $6,800,000 for the six months ended October 31, 2011 and October 31, 2010, respectively.

On October 3, 2011 through October 19, 2011, the Company was subject to an inspection by the FDA. The inspection resulted in seven observations on Form 483, an FDA form on which deficiencies are noted after an FDA inspection, with inspector observations. The Company responded to those observations on November 7, 2011 and believes that its response to these observations was adequate.

[2] Legal Proceedings:

On March 19, 2010, Midlothian received a subpoena duces tecum demanding production of Midlothian business records in connection with an investigation by the Office of Inspector General of the United States Department of Health & Human Services relating to Medicare or Medicaid reimbursement for certain drugs. The Company has produced documents in response to the subpoena. No claims for damages have been made. The Company has no estimate at this time of its potential exposure and cannot, at this time, predict the outcome of this matter.

On March 5, 2010 in the United States District Court for the Northern District of California, a complaint was filed naming the Company and several pharmaceutical and other companies as defendants under the qui tam provisions of the federal civil False Marketing Statute. A private plaintiff, San Francisco Technology Inc., filed the civil action under the Statute on behalf of the federal government. The complaint alleges that the Company falsely marked the packaging of a product with regard to patents that had expired. The product was marketed by the Company’s Health Care Products Division under the Zostrix^® Neuropathy brand. The complaint alleges these actions violate the federal civil False Marketing Statute. The Company was served with the complaint on March 22, 2010. On July 19, 2010, the judge ordered that the Company be severed from the action and transferred to the Eastern District of New York. The Company settled for an immaterial amount and the case was dismissed with prejudice on July 21, 2011.

On February 9, 2010, in the United States District Court for the District of Massachusetts (the “Federal District Court”), a “Partial Unsealing Order” was issued and unsealed in a civil case naming several pharmaceutical companies as defendants under the qui tam provisions of the federal civil False Claims Act (the “Qui Tam Complaint”). The qui tam provisions permit a private person, known as a “relator” (sometimes referred to as a “whistleblower”), to file civil actions under this statute on behalf of the federal and state governments. Pursuant to the Order, a Revised Corrected Seventh Amended Complaint was filed by the relator and unsealed on February 10, 2010. The relator in the Complaint is Constance A. Conrad. The Complaint alleges that several pharmaceutical companies submitted false records or statements to the United States through the Center for Medicare and Medicaid Services (“CMS”) and thereby caused false claims for payments to be made through state Medicaid Reimbursement programs for unapproved or ineffective drugs or for products that are not drugs at all. The Complaint alleges that the drugs were “New Drugs” that the FDA had not approved and that are expressly excluded from the definition of “Covered Outpatient Drugs”, which would have rendered them eligible for Medicaid reimbursement. The Complaint alleges these actions violate the federal civil False Claims Act. The Revised Corrected Seventh Amended Complaint did not name the Company as a defendant.

On February 9, 2010, the Court also unsealed the “United States’ Notice of Partial Declination” in which the government determined not to intervene against 68 named defendants, including the Company. On July 23, 2010, the relator further amended the Complaint, which, as amended, named the Company, including a subsidiary of the Company, as a defendant. On January 6, 2011, the Court issued an order unsealing the government’s notice of election to intervene as to a previously unnamed defendant. On July 25, 2011, the Court issued an order stating, among other things, that all parties agreed that the only defendant against whom the United States has elected to intervene is the previously unnamed defendant. On July 26, 2011, the relator filed its Tenth Amended Complaint, which removed the allegations against the Company’s subsidiary, but not the Company, realleging them against another party. The Company intends to vigorously defend against the remaining allegations in the relator’s Complaint. The Company cannot predict the outcome of the action.

On June 5, 2009, Allergan, Inc. (“Allergan”) filed a complaint against the Company in the United States District Court for the Eastern District of Texas, Civil Action No. 2:09-cv-182, in response to the Company’s Paragraph IV certifications in ANDA No. 91-086 (the “ANDA”) alleging noninfringement or invalidity of the United States patents identified in the Orange Book on Allergan’s product, Combigan^®. In counts one and two of the complaint, Allergan alleges that the Company’s submission of the ANDA to the FDA under Section 505(j) of the Food, Drug & Cosmetic Act (“FDCA”) to obtain approval to engage in the commercial manufacture, use or sale of the Company’s generic Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5% product infringes U.S. Patents No. 7,030,149 and 7,320,976. On November 20, 2009, Allergan filed an amended complaint adding a claim for infringement of U.S. Patent No. 7,323,463. The Company answered the amended complaint on December 10, 2009, asserting counterclaims of non-infringement and invalidity as to all asserted patents. Allergan replied to the Company’s counterclaims on January 4, 2010. On March 17, 2010, Allergan filed a second complaint adding allegations of infringement of U.S. Patent No. 7,642,258. The Company answered on March 19, 2010 denying infringement of any valid claims. The Company settled with Allergan on May 20, 2011 without incurring a liability payment and the case was dismissed with prejudice on May 31, 2011.

On August 17, 2011, Allergan, Inc. and Duke University filed a complaint against the Company in the United States District Court for the Middle District of North Carolina in response to the Company’s Paragraph IV certifications in its ANDA for Bimatoprost Topical Solution 0.03%, alleging infringement of U.S Patents Nos. 7,351,404; 7,388,029; and 6,403,649 for Allergan’s product, Latisse. On October 7, 2011, the Company answered the complaint asserting counterclaims. The plaintiffs responded to the counterclaims on October 31, 2011. The Company believes the complaint is without merit and intends to vigorously defend against the allegations in the complaint. The Company cannot predict the outcome of the action.

On October 11, 2011 Senju Pharmaceutical Co.; Kyorin Pharmaceutical Co.; and Allergan Inc filed a complaint in the District Court of Delaware, Civil Action No. 1:11-cv-00926; ; in response to the Company’s Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Allergan’s Zymaxid^® (gatifloxacin ophthalmic solution, 0.5%). ).The complaint alleges infringement of U.S. Patent Nos. 6,333,045 (“Aqueous Liquid Pharmaceutical Composition Comprised of Gatifloxacin,” issued December 25, 2001) and 5,880,283 (“8-Alkoxyquinolonecarboxylic Acid Hydrate With Excellent Stability and Process for Producing the Same,” issued March 9, 1999), licensed to Allergan, The Company believes the complaint is without merit and intends to vigorously defend against the allegations in the complaint. The Company cannot predict the outcome of the action.

On October 31, 2011 Senju Pharmaceutical Co.; Kyorin Pharmaceutical Co.; and Allergan Inc filed a complaint in the District Court of Delaware, Civil Action No. 1:11-cv-01059, in response to the Company’s Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Allergan’s Zymar^® (gatifloxacin ophthalmic solution, 0.3% ). The complaint alleges infringement of U.S. Patent Nos. 6,333,045 (“Aqueous Liquid Pharmaceutical Composition Comprised of Gatifloxacin,” issued on December 25, 2001) and 5,880,283 (“8-Alkoxyquinolonecarboxylic Acid Hydrate With Excellent Stability And Process For Producing The Same,” issued March 9, 1999), licensed to Allergan. The Company believes the complaint is without merit and intends to vigorously defend against the allegations in the complaint. The Company cannot predict the outcome of the action.

[3] Commitments and Contingencies:

The Company’s ECR Pharmaceuticals subsidiary currently leases approximately 12,000 square feet in Richmond, VA. This lease ends August 31, 2014.

In June 2010, the Company entered into an agreement to lease a parking lot in Amityville, NY. The Company will pay $90,000 over a five year period.

In the course of its business, the Company enters into agreements which require the Company to make royalty payments which are generally based on net sales or gross profits of certain products.

In connection with the Tussicaps^® acquisition, the Company entered into a manufacturing agreement which requires the Company to make a minimum purchase of $500,000 in the first year and $1,000,000 per year over the next four years.

14. RECENT ACCOUNTING PRONOUNCEMENTS:

The FASB has issued ASU 2010-29, Business Combinations (Topic 805): Disclosure of Supplementary Pro Forma Information for Business Combinations. The amendments in this ASU affect any public entity as defined by Topic 805, Business Combinations, that enters into business combinations that are material on an individual or aggregate basis. The amendments in this ASU specify that if a public entity presents comparative financial statements, the entity should disclose revenue and earnings of the combined entity as though the business combination(s) that occurred during the current year had occurred as of the beginning of the comparable prior annual reporting period only. The amendments also expand the supplemental pro forma disclosures to include a description of the nature and amount of material, nonrecurring pro forma adjustments directly attributable to the business combination included in the reported pro forma revenue and earnings. The amendments were effective prospectively for business combinations to be completed by the Company after May 1, 2011. The adoption of this guidance had no material impact on the consolidated financial statements of the Company.

In December 2010, the FASB updated the accounting guidance relating to the annual goodwill impairment test. The updated guidance requires companies to perform the second step of the impairment test to measure the amount of impairment loss, if any, when it is more likely than not that goodwill impairment exists when the carrying amount of a reporting unit is zero or negative. In considering whether it is more likely than not that goodwill impairment exists, an entity shall evaluate whether there are adverse qualitative factors. The updated guidance is effective for the Company beginning in the first quarter of fiscal 2012. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.

In June 2011, the FASB updated the disclosure requirements for comprehensive income. The updated guidance requires companies to disclose the total of comprehensive income, the components of net income, and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements. The updated guidance does not affect how earnings per share is calculated or presented. The updated guidance is effective for the Company beginning in the first quarter of fiscal year 2013. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.

In September 2011, the FASB issued ASU 2011-08, Intangibles—Goodwill and Other (Topic 350): Testing Goodwill for Impairment, which amended its guidance on the testing of goodwill impairment to allow an entity the option to first assess qualitative factors to determine whether performing the current two-step process is necessary. Under the new option, the calculation of the reporting unit’s fair value is not required unless as a result of the qualitative assessment, it is more likely than not that the fair value of the reporting unit is less than the unit’s carrying amount. This guidance is effective for fiscal years and interim periods beginning after December 15, 2011, with early adoption permitted. The adoption of this standard will not have an impact on the Company’s financial statements.

15. COMPREHENSIVE INCOME:

In accordance with FASB ASC Topic 220-10, “Comprehensive Income,” the Company is required to report all changes in equity during a period, except those resulting from investment by owners and distribution to owners, for the period in which they are recognized. Comprehensive income is the total of net income and all other non-owner changes in equity (or other comprehensive income) such as unrealized gains/losses on securities classified as available for sale.

The Company’s investment in Neuro-Hitech, Inc., a marketable security, was classified as available for sale and measured at fair value with the adjustment to fair value and changes therein recorded in accumulated other comprehensive income. The Company wrote off the investment in Neuro-Hitech, Inc. during the year ended April 30, 2011 based on the decline in the stock price and the limited trading activity.


	Six months ended October 31,
	2011		2010
Net income	$	27,556,000	$	18,651,000
Other comprehensive (loss) income		—		(11,000	)

Comprehensive income	$	27,556,000	$	18,640,000

16. SIGNIFICANT CUSTOMERS AND CONCENTRATION OF CREDIT RISK:

For the six months ended October 31, 2011, three customers, McKesson, AmerisourceBergen and Cardinal Health, accounted for net sales of approximately 14%, 9% and 9%, respectively. These customers represented approximately 54% of accounts receivable at October 31, 2011. For the six months ended October 31, 2010, three customers, AmerisourceBergen, McKesson, and Cardinal Health, accounted for net sales of approximately 16%, 12% and 11%, respectively. These customers represented approximately 51% of accounts receivable at October 31, 2010.

The Company maintains cash and cash equivalents primarily with major financial institutions. Such amounts exceed FDIC limits.

17. FAIR VALUE MEASUREMENTS:

The accounting guidance under Accounting Standards Codification (“ASC”) “Fair Value Measurements and Disclosures” (“ASC 820-10”) utilizes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. A brief description of those levels is as follows:

•

Level 1: Observable inputs such as quoted prices in active markets for identical assets or liabilities.

•

Level 2: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly

•

Level 3: Significant unobservable inputs.

The Company’s financial liabilities subject to fair value measurements as of October 31, 2011 was as follows:


Fair Value Measurements Using Fair Value Hierarchy
	Fair Value		Level 3
Contingent payment liability	$	12,014,000	$	12,014,000

The fair value of the contingent payment liability was estimated using the present value of management’s projection of the expected payments pursuant to the term of the Tussicaps^® agreement (see Note 7).

The carrying value of certain financial instruments such as cash and cash equivalents, accounts receivable and accounts payable approximate their fair values due to their short-term nature of their underlying terms. The carrying value of the long-term debt approximate its fair value based upon its interest rate, which approximates current market interest.

18. SUBSEQUENT EVENTS:

On November 28, 2011, the Company entered into an asset purchase agreement to acquire an ANDA for a product and all product intellectual property. The purchase price of the ANDA and interest in the intellectual property is up to $3,000,000, under certain conditions and is payable in installments over twenty four months. In connection with this asset purchase, the Company has entered into a collaboration agreement and profit sharing agreement with another party. The Company and the other party will each own 50% of the product and will each pay equal amounts in satisfaction of the purchase price obligation. The other party will also pay 50% of the development costs and share in 50% of the net profits. Hi-Tech made an initial payment of $375,000 on November 29, 2011.

The Company has the right to terminate this agreement at any time and not pay subsequent installments. Upon termination by the Company, all interests in the assets acquired will be transferred back to the seller.

ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This Report on Form 10-Q and certain information incorporated herein by reference contain forward-looking statements which are not historical facts made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not promises or guarantees and investors are cautioned that all forward-looking statements involve risks and

uncertainties, including but not limited to the impact of competitive products and pricing, product demand and market acceptance, new product development, the regulatory environment, including without limitation, reliance on key strategic alliances, availability of raw materials, fluctuations in operating results and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission. These statements are based on management’s current expectations and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements which speak only as of the date made. Hi-Tech is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

RESULTS OF OPERATIONS FOR THREE MONTHS ENDED OCTOBER 31, 2011 AND 2010

Revenue


	October 31, 2011		October 31, 2010		Change			% Change
Hi-Tech Generics	$	48,667,000	$	36,561,000	$	12,106,000			33	%
Health Care Products		4,697,000		3,350,000		1,347,000			40	%
ECR Pharmaceuticals		3,511,000		4,745,000		(1,234,000	)		(26	)%

Total	$	56,875,000	$	44,656,000	$	12,219,000			27	%

Net sales of Hi-Tech generic pharmaceutical products, which include some private label contract manufacturing, increased due to an increase in sales of Fluticasone Propionate nasal spray. Sales of these products increased to $23,000,000 from $17,300,000 in the comparable quarter as the Company sold more units, but at a lower average price. Sales of Dorzolamide with Timolol ophthalmic solution and Dorzolamide ophthalmic solution dropped to $4,200,000 in the quarter versus $8,100,000 in the comparable quarter due to lower pricing for the products and lower unit volume. The Company also benefited from the recent launch of Gabapentin oral solution, launched in February 2011, Ranitidine oral solution, launched in May 2011, Levofloxacin oral solution, launched in June 2011 and Lidocaine sterile jelly, launched in September 2011. Increased sales of the Company’s Clobetasol line of topical products and Buprenorphine also contributed to the results.

Net sales of the Health Care Products division, which markets the Company’s branded OTC products, increased due to an increase in sales of Zostrix^® and Diabetiderm^® OTC products.

Net sales of ECR Pharmaceuticals, which sells branded prescription products, declined due to the discontinuation of Lodrane^® extended release antihistamines. On March 2, 2011, the FDA indicated in its MedWatch publication that the FDA removed approximately 500 currently marketed cough/cold and allergy related products. Three of these were marketed by ECR Pharmaceuticals under the brand name Lodrane^®. ECR Pharmaceuticals stopped shipping these products as of August 31, 2011. Sales of Lodrane^® products amounted to approximately $400,000 and $4,100,000 for the three months ended October 31, 2011 and October 31, 2010, respectively. Increased sales of Bupap^® and Dexpak^® and sales from newly acquired Cephadyn^®, Orbivan^®, Tussicaps^® and Zolvit^® partially offset the decrease in sales for the quarter.

Effective May 1, 2011, the Company sold various assets of its Midlothian Laboratories division, and the sales from this business are included in discontinued operations.

Cost of Goods Sold


	October 31, 2011					October 31, 2010
	$		% of sales			$		% of sales
Cost of goods sold		23,479,000		41	%		19,525,000		44	%

The decrease in cost of goods sold as a percentage of net sales is primarily due to increased sales of Fluticasone Propionate nasal spray and the impact of newly launched products such as Gabapentin oral solution, Levofloxacin oral solution and Lidocaine sterile jelly which all have higher than average margins.

Expense Items


	October 31, 2011			October 31, 2010			Change			% Change
Selling, general and administrative expense	$	11,859,000		$	8,628,000		$	3,231,000			37	%
Research and product development costs	$	2,468,000		$	2,402,000		$	66,000			3	%
Royalty income	$	(829,000	)	$	(1,177,000	)	$	348,000			(30	)%
Contract research income	$	(1,000	)	$	(429,000	)	$	428,000			(100	)%
Interest expense	$	31,000		$	12,000		$	19,000			158	%
Interest income and other	$	(282,000	)	$	(178,000	)	$	(104,000	)		58	%
Provision for income tax expense	$	6,367,000		$	5,450,000		$	917,000			17	%

The increase in selling, general and administrative expenses was primarily due to increased amortization associated with the acquisition of marketing and distribution rights to Tussicaps^® extended-release capsules from Mallinckrodt and several branded products for the treatment of pain from Atley Pharmaceuticals. Additionally, the Company experienced increases in legal expenses and advertising in the HCP division.

Royalty income decreased because royalties relating to Brometane, a cough and cold product which the Company divested in July 2008, ended in December 2010.

The effective tax rate declined to approximately 33% from 34% as the Company recorded a higher benefit from the exercise of stock options in the current period.

Income Analysis


	October 31, 2011		October 31, 2010			Change		% Change
Income from continuing operations	$	13,783,000	$	10,423,000		$	3,360,000		32	%
Loss from discontinued operations, net of tax		—		(447,000	)		447,000		100	%

Net income	$	13,783,000	$	9,976,000		$	3,807,000		38	%

Basic earnings per share:
Continuing operations		1.08		0.83			0.25		30	%
Discontinued operations		0.00		(0.04	)		0.04		100	%

Basic earnings per share	$	1.08	$	0.79		$	0.29		37	%

Diluted earnings per share:
Continuing operations		1.04		0.79			0.25		32	%
Discontinued operations		0.00		(0.03	)		0.03		100	%

Diluted earnings per share	$	1.04	$	0.76		$	0.28		37	%

Weighted average common shares outstanding, basic		12,761,000		12,585,000			176,000		1	%
Effect of potential common shares		543,000		459,000			84,000		18	%
Weighted average common shares outstanding, diluted		13,304,000		13,044,000			260,000		2	%

Shares outstanding increased due to the exercise of options.

RESULTS OF OPERATIONS FOR SIX MONTHS ENDED OCTOBER 31, 2011 AND 2010

Revenue


	October 31, 2011		October 31, 2010		Change			% Change
Hi-Tech Generics	$	97,637,000	$	68,846,000	$	28,791,000			42	%
Health Care Products		8,232,000		6,880,000		1,352,000			20	%
ECR Pharmaceuticals		7,217,000		8,239,000		(1,022,000	)		(12	)%

Total	$	113,086,000	$	83,965,000	$	29,121,000			35	%

Net sales of Hi-Tech generic pharmaceutical products, which include some private label contract manufacturing, increased due to an increase in sales of Fluticasone Propionate nasal spray. Sales of these products increased to $49,200,000 from $29,000,000 in the comparable period as the Company sold more units. Sales of Dorzolamide with Timolol ophthalmic solution and Dorzolamide ophthalmic solution dropped to $11,000,000 in the period versus $16,000,000 in the comparable period due to lower pricing for the products and slightly lower unit volume. The Company temporarily halted sales of several unapproved products in late June 2010, so the six months ended October 31, 2011 did not include any sales of these products. The Company also benefited from the recent launch of Gabapentin oral solution, launched in February 2011, Ranitidine oral solution, launched in May 2011, Levofloxacin oral solution, launched in June 2011 and Lidocaine sterile jelly, launched in September 2011. Increased sales of the Company’s Clobetasol line of topical products and Buprenorphine also contributed to the results.

Net sales of the Health Care Products division, which markets the Company’s branded OTC products, increased due to an increase in sales of Diabetiderm^® and Zostrix^® products as well as sales of the relaunched Nasal Ease^® brand.

Net Sales of ECR Pharmaceuticals, which sells branded prescription products, declined due to the discontinuation of Lodrane^® extended release antihistamines. On March 2, 2011, the FDA indicated in its MedWatch publication that the FDA removed approximately 500 currently marketed cough/cold and allergy related products. Three of these were marketed by ECR Pharmaceuticals under the brand name Lodrane^®. ECR Pharmaceuticals stopped shipping these products as of August 31, 2011. Sales of Lodrane^® products amounted to approximately $2,800,000 and $6,800,000 for the six months ended October 31, 2011 and October 31, 2010, respectively. Increased sales of Bupap^® and Dexpak^® and sales from newly acquired Cephadyn^®, Orbivan^®, Tussicaps^® and Zolvit^® partially offset the decrease in sales for the quarter.

Effective May 1, 2011, the Company sold various assets of its Midlothian Laboratories division, and the sales from this business are included in discontinued operations.

Cost of Goods Sold


	October 31, 2011					October 31, 2010
	$		% of sales			$		% of sales
Cost of goods sold		46,454,000		41	%		36,291,000		43	%

Expense Items


	October 31, 2011			October 31, 2010			Change			% Change
Selling, general and administrative expense	$	21,430,000		$	17,648,000		$	3,782,000			21	%
Research and product development costs	$	5,867,000		$	4,348,000		$	1,519,000			35	%
Royalty income	$	(1,395,000	)	$	(2,221,000	)	$	826,000			(37	)%
Contract research (income)	$	(28,000	)	$	(617,000	)	$	589,000			(95	)%
Interest expense	$	46,000		$	22,000		$	24,000			109	%
Interest (income) and other	$	(306,000	)	$	(216,000	)	$	(90,000	)		42	%
Provision for income tax expense	$	13,462,000		$	9,762,000		$	3,700,000			38	%

The increase in Research and Development expenditures is due to increased spending on internal projects for the generic division, including an increase in the internal R&D staff. Additionally, the Company increased expenditures on three generic projects requiring clinical trials which it has undertaken with partners.

Royalty income decreased because royalties relating to Brometane, a cough and cold product which the Company divested in July 2008, ended in December 2010.

The effective tax rate declined to 33% from 34% as the Company recorded a higher benefit from the domestic production activities tax credit and the exercise of stock options in the current period.

Income Analysis


	October 31, 2011		October 31, 2010			Change		% Change
Income from continuing operations	$	27,556,000	$	18,948,000		$	8,608,000		45	%
Loss from discontinued operations, net of tax		—		(297,000	)		297,000		100	%

Net income	$	27,556,000	$	18,651,000		$	8,905,000		48	%

Basic earnings per share:
Continuing operations		2.16		1.50			0.66		44	%
Discontinued operations		0.00		(0.02	)		0.02		100	%

Basic earnings per share	$	2.16	$	1.48		$	0.68		46	%

Diluted earnings per share:
Continuing operations		2.08		1.45			0.63		43	%
Discontinued operations		0.00		(0.02	)		0.02		100	%

Diluted earnings per share	$	2.08	$	1.43		$	0.65		45	%

Weighted average common shares outstanding, basic		12,744,000		12,577,000			167,000		1	%
Effect of potential common shares		483,000		477,000			6,000		1	%
Weighted average common shares outstanding, diluted		13,227,000		13,054,000			173,000		1	%

Shares outstanding increased due to the exercise of options.

LIQUIDITY AND CAPITAL RESOURCES

The Company’s operations are historically financed principally by cash flow from operations. At October 31, 2011 and April 30, 2011, working capital was approximately $146,259,000 and $132,135,000, respectively, an increase of $14,124,000 during the six months ended October 31, 2011.

Cash flows provided by operating activities were approximately $24,328,000 which is primarily due to net income in the period and a decrease in accounts receivable. The decrease in accounts receivable was primarily due to timing of sales at the end of the April 30, 2011 quarter. This trend was partially offset by an increase in inventory. Part of the increase in inventory is due to a buildup of Fluticasone Propionate nasal spray in anticipation of the spring allergy season.

Cash flows used in investing activities were $17,936,000 and were mostly for acquisition of marketing and distribution rights of new branded products and for capital expenditures primarily related to capacity expansion at the Company’s Amityville facilities.

Cash flows provided by financing activities of $2,880,000 related to the proceeds from exercise of stock options and the related tax benefits, as well as borrowings from the equipment financing agreement.

The Company believes that its financial resources consisting of current working capital and anticipated future operating revenue will be sufficient to enable it to meet its working capital requirements for at least the next 12 months. Additionally, the Company has a $10,000,000 revolving line of credit with JPMorgan Chase which remains undrawn, and an additional $3,224,000 of the equipment financing line from JPMorgan Chase. The revolving line of credit agreement expires May 27, 2013, while borrowings under the equipment line mature October 6, 2016.

Subsequent to July 31, 2011, in connection with the TussiCaps^® acquisition, the Company failed to comply with certain covenants limiting the dollar amount of acquisitions, contained in one of its financing agreements with JPMorgan Chase. Hi-Tech’s breach of those covenants resulted in the Company being in technical default of both financing agreements, which gave the lender rights to call all outstanding debts under the financing agreements due and payable and to terminate its credit commitment. The lender granted waivers for the breach of these covenants.

REVOLVING CREDIT FACILITY

The Company also entered into a $5,000,000 equipment financing agreement with JPMorgan Chase on June 1, 2010. This agreement has similar interest rates. On June 15, 2010 the Company drew down $621,000 of the equipment financing line to fund a down payment for new filling and packaging equipment. On October 13, 2011, the Company borrowed an additional $1,155,000 to finance the remaining payments for the equipment. Total borrowings under the equipment financing agreement amount to $1,776,000 as of October 31, 2011. Borrowings under the equipment financing agreement are payable in monthly installments of $30,000 through October 6, 2016.

The Company may not declare or pay dividends or distributions, other than dividends payable solely in capital stock, so long as the Revolving Credit Note remains unpaid.

RECENT ACCOUNTING PRONOUNCEMENTS:

In September 2011, the FASB issued ASU 2011-08, Intangibles – Goodwill and Other (Topic 350): Testing Goodwill for Impairment, which amended its guidance on the testing of goodwill impairment to allow an entity the option to first assess qualitative factors to determine whether performing the current two-step process is necessary. Under the new option, the calculation of the reporting unit’s fair value is not required unless as a result of the qualitative assessment, it is more likely than not that the fair value of the reporting unit is less than the unit’s carrying amount. This guidance is effective for fiscal years and interim periods beginning after December 15, 2011, with early adoption permitted. The adoption of this standard will not have an impact on the Company’s financial statements.

SEASONALITY

Historically, the months of September through March account for a greater portion of the Company’s sales than the other months of the fiscal year. However, this sales pattern is unlikely to continue as the Company sells fewer cough and cold products, more allergy products and more products without seasonal fluctuations. Even with these changes in product mix, period-to-period comparisons within the same fiscal year are not necessarily meaningful and should not be relied on as indicative of future results.

CRITICAL ACCOUNTING POLICIES

In preparing financial statements in conformity with generally accepted accounting principles in the United States of America, we are required to make estimates and assumptions that affect reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and revenues and expenses for the reporting period covered thereby. As a result, these estimates are subject to an inherent degree of uncertainty. We base our estimates and judgments on our historical experience, the terms of existing contracts, our observance of trends in the industry, information that we obtain from our customers and outside sources, and on various assumptions that we believe to be reasonable and appropriate under the circumstances, the results of which form the basis for making judgments which impact our reported operating results and the carrying values of assets and liabilities. These assumptions include but are not limited to the percentage of new products which may have chargebacks and the percentage of items which will be subject to price decreases. Actual results may differ from these estimates.

Revenue recognition and accounts receivable, adjustments for returns and price adjustments, allowance for doubtful accounts and carrying value of inventory represent significant estimates made by management.

Revenue Recognition and Accounts Receivable: Revenue is recognized for product sales upon shipment and when title and risk of loss is passed to the customer and when estimates of discounts, rebates, promotional adjustments, price adjustments, returns, chargebacks, and other potential adjustments are reasonably determinable, collection is reasonably assured and the Company has no further performance obligations. These estimates are presented in the financial statements as reductions to net revenues and accounts receivable. Estimated sales returns, allowances and discounts are provided for in determining net sales. Contract research income is recognized as work is completed and billable costs are incurred. In certain cases, contract research income is based on attainment of designated milestones.

Royalty income is related to the sale or use of our products under license agreements with third parties. For those agreements where royalties are reasonably estimable, the Company recognizes revenue based on estimates of royalties earned during the applicable period.

Adjustments for Returns and Price Adjustments: Our product revenues are typically subject to agreements with customers allowing chargebacks, rebates, rights of return, pricing adjustments and other allowances. Based on our agreements and contracts with our customers, we calculate adjustments for these items when we recognize revenue and we book the adjustments against accounts receivable and revenue. Chargebacks, primarily from wholesalers, are the most significant of these items. Chargebacks result from arrangements we have with retail customers establishing prices for products for which the end user independently selects a wholesaler from which to purchase. A chargeback represents the difference between our invoice price to the wholesaler, which is typically stated at wholesale acquisition cost, and the end customer’s contract price, which is lower. We credit the wholesaler for purchases by end customers at the lower price. Therefore, we record these chargebacks at the time we recognize revenue in connection with our sales to wholesalers.

The reserve for chargebacks is computed in the following manner. The Company obtains wholesaler inventory data for the wholesalers which represent approximately 95% of our chargeback activity. This inventory is multiplied by the historical percentage of units that are charged back and by the price adjustment per unit to arrive at the chargeback accrual. This calculation is performed by product for each customer.

The calculated amount of chargebacks could be affected by other factors such as:

•

A change in retail customer mix

•

A change in negotiated terms with retailers

•

Product sales mix at the wholesaler

•

Retail inventory levels

•

Changes in Wholesale Acquisition Cost (WAC)

The Company continually monitors the chargeback activity and adjusts the provisions for chargebacks when we believe that the actual chargebacks will differ from our original provisions.

Consistent with industry practice, the Company maintains a return policy that allows our customers to return product within a specified period. The Company’s estimate for returns is based upon its historical experience with actual returns. While such experience has allowed for reasonable estimation in the past, history may not always be an accurate indicator of future returns. The Company continually monitors its estimates for returns and makes adjustments when it believes that actual product returns may differ from the established accruals.

Included in the adjustment for sales allowances and returns is a reserve for credits taken by our customers for rebates, return authorizations and other.

Sales discounts are granted for prompt payment. The reserve for sales discounts is based on invoices outstanding and assumes that 100% of available discounts will be taken.

Price adjustments, including shelf stock adjustments, are credits issued from time to time to reflect decreases in the selling prices of our products which our customer has remaining in its inventory at the time of the price reduction. Decreases in our selling prices are discretionary decisions made by us to reflect market conditions. Amounts recorded for estimated price adjustments are based upon specified terms with direct customers, estimated launch dates of competing products, estimated declines in market price and inventory held by the customer. The Company analyzes this on a case by case basis and makes adjustments to reserves as necessary.

The Company adequately reserves for chargebacks, discounts, allowances and returns in the period in which the sales takes place. No material amounts included in the provision for chargebacks and the provision for sales discounts recorded in the current period relate to sales made in the prior periods. The current provision for sales allowances and returns includes reserves for items sold in the current period, while the ending balance includes reserves for items sold in the current and prior periods. The Company has substantially and consistently used the same estimating methods. We continue to refine the methods as new data becomes available. There have been no material differences between the estimates applied and actual results.

The Company determines amounts that are material to the financial statements in consideration of all relevant circumstances including quantitative and qualitative factors. Among the items considered is the impact on individual financial statement classification, operating income and footnote disclosures and the degree of precision that is attainable in estimating judgmental items.

The following table presents the roll forward of each significant estimate as of October 31, 2011 and October 31, 2010 and for the three months then ended, respectively.


*For the six months ended October 31, 2011*	Beginning Balance May 1		Current Provision		Actual Credits in Current Period			Ending Balance October 31
Chargebacks	$	8,588,000	$	64,884,000	$	(64,065,000	)	$	9,407,000
Sales discounts		2,353,000		4,349,000		(4,842,000	)		1,860,000
Sales allowances & returns		6,159,000		17,650,000		(16,434,000	)		7,375,000

Total adjustment for returns & price allowances	$	17,100,000	$	86,883,000	$	(85,341,000	)	$	18,642,000


*For the six months ended October 31, 2010*
Chargebacks	$	6,509,000	$	58,859,000	$	(54,178,000	)	$	11,190,000
Sales discounts		1,391,000		3,479,000		(3,403,000	)		1,467,000
Sales allowances & returns		6,470,000		15,257,000		(16,865,000	)		4,862,000

Total adjustment for returns & price allowances	$	14,370,000	$	77,595,000	$	(74,446,000	)	$	17,519,000

Allowance for Doubtful Accounts: We have historically provided credit terms to customers in accordance with what management views as industry norms. Financial terms for credit-approved customers are generally on either a net 30 or 60 day basis, though most customers are entitled to a prompt payment discount. Management periodically and regularly reviews customer account activity in order to assess the adequacy of allowances for doubtful accounts, considering factors such as economic conditions and each customer’s payment history and creditworthiness. If the financial condition of our customers were to deteriorate, or if they were otherwise unable to make payments in accordance with management’s expectations, we would have to increase our allowance for doubtful accounts.

Inventories: We state inventories at the lower of average cost or market, with cost being determined based upon the average method. In evaluating whether inventory is to be stated at cost or market, management considers such factors as the amount of inventory on hand, estimated time required to sell existing inventory and expected market conditions, including levels of competition. We establish reserves for slow-moving and obsolete inventories based upon our historical experience, product expiration dates and management’s assessment of current product demand.

Intangible Assets: The Company’s intangible assets consist primarily of acquired product rights. Intangible assets are stated at cost and amortized using the straight line method over the expected useful lives of the product rights. We regularly review the appropriateness of the useful lives assigned to our product rights taking into consideration potential future changes in the markets for our products. The Company reviews each intangible asset with finite useful lives for impairment by comparing the undiscounted cash flows of each asset to the respective carrying value. The Company performs this impairment testing when events occur or circumstances change that would more likely than not reduce the undiscounted cash flows of the asset below its carrying value.

CONTRACTUAL OBLIGATIONS AND OFF-BALANCE SHEET ARRANGEMENTS

The Company’s contractual obligations and commitments are detailed in the Company’s Annual Report on Form 10-K for the year ended April 30, 2011. As of October 31, 2011, the Company’s remaining contractual obligations have not materially changed since April 30, 2011.

As part of our ongoing business, we do not participate in transactions that generate relationships with unconsolidated entities or financial partnerships which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. As of October 31, 2011 we are not involved in any material unconsolidated transactions.

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

The Company invests in U.S. treasury notes, government asset backed securities and corporate bonds, all of which are exposed to interest rate fluctuations. The interest earned on these investments may vary based on fluctuations in the market interest rate.

ITEM 4.

CONTROLS AND PROCEDURES

Under the supervision and with the participation of the Company’s management, including the Company’s Chief Executive Officer and Chief Financial Officer, the Company has evaluated the effectiveness of the design and operation of its disclosure controls and procedures within 90 days of the filing date of this quarterly report, and, based on their evaluation, the Chief Executive Officer and Chief Financial Officer have concluded that these disclosure controls and procedures are effective. There were no significant changes in our internal controls or in other factors that could significantly affect these controls subsequent to the date of their evaluation.

PART II. OTHER INFORMATION

ITEM 1.

LEGAL PROCEEDINGS

The disclosure under Note 13, Contingencies and Other Matters, Legal Proceedings, included in Part I of this report, is incorporated in this Part II, Item 1 by reference.

ITEM 1A.

RISK FACTORS

Not applicable

ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS


Period	Total Number of Shares Purchased		Average Price per Share		Total Number of Shares Purchased as Part of Publicly Announced Plans		Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans (1)
08/01/11 – 08/31/11		0	$	0		0	$	0
09/01/11 – 09/30/11		0	$	0		0	$	0
10/01/11 – 10/31/11		0	$	0		0	$	0

(1)	The Company’s Board of Directors has authorized $23,000,000 to repurchase the Company’s common stock. To date the Company has purchased 2,456,000 shares for the full $23,000,000 authorization. There are no further repurchases planned at this time.

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES

None

ITEM 4.

RESERVED

ITEM 5.

OTHER INFORMATION

None

ITEM 6.

EXHIBITS

(a)

Exhibits



31.1		Rule 13A-14(a)/15D-14(a) Certification

31.2		Rule 13A-14(a)/15D-14(a) Certification

32		Certification of Officers Pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2003

101.INS**		XBRL Instance Document.

101.SCH**		XBRL Taxonomy Extension Schema Document.

101.CAL**		XBRL Taxonomy Extension Calculation Linkbase Document.

101.LAB**		XBRL Taxonomy Extension Label Linkbase Document.

101.PRE**		XBRL Taxonomy Extension Presentation Linkbase Document.

101.DEF**		XBRL Taxonomy Extension Definition Linkbase Document.

SIGNATURES

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.

HI-TECH PHARMACAL CO., INC.

(Registrant)

Date: December 8, 2011



By:		/S/ DAVID S. SELTZER
		David S. Seltzer (President and Chief Executive Officer)

Date: December 8, 2011



By:		/S/ WILLIAM PETERS
		William Peters (Vice President and Chief Financial Officer)

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company