UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

 

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FORM 8-K

 

Current Report

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

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Date of Report (Date of earliest event reported):  May 15, 2015

 

ANI PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware		001-31812		58-2301143
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification Number)

 

210 Main Street West Baudette, Minnesota		56623
(Address of principal executive offices)		(Zip Code)

 

Registrant’s telephone number, including area code:  (218) 634-3500

 

 

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

  

Item 7.01

Regulation FD Disclosure.

 

On May 15, 2015, ANI Pharmaceuticals, Inc. (the “Company,” “we” or “us”) announced that Arthur S. Przybyl, President and CEO, will present at the UBS Global Healthcare Conference, which presentation will be webcast live at http://cc.talkpoint.com/ubsx001/051815a_ae/?entity=92_SX3YVF2 at 11:00 AM ET on Wednesday, May 20, 2015. The live webcast will be archived and available for 90 days, through August 18, 2015.

 

On May 15, 2015, we posted to our website our May 2015 Corporate Presentation. We may use this presentation in our communications or at conferences. The presentation is available on our website, www.anipharmaceuticals.com, and is attached to this Current Report on Form 8-K as Exhibit 99.2 and incorporated into this Item 7.01 by reference.

 

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Forward-Looking Statements

 

Certain statements contained in the presentation slides furnished with this report contain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future operations, products, financial position, operating results, prospects, pipeline or potential markets therefor, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words, and the use of future dates.

 

Uncertainties and risks may cause our actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to, the risk that we may face with respect to importing raw materials, increased competition, delays or failure in obtaining product approval from the U.S. Food and Drug Administration ("FDA"), general business and economic conditions, market trends, product development, regulatory and other approvals and marketing.

 

More detailed information on these and additional factors that could affect our actual results are described in our filings with the Securities and Exchange Commission, including our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as our proxy statement/prospectus, filed with the Securities and Exchange Commission on April 24, 2015. The forward-looking statements contained in this document are made only as of the date of this document. We undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

  

Item 9.01

Financial Statements and Exhibits.

 

(d)

Exhibits

 

No.		Description
99.1		Press release, dated May 15, 2015, issued by ANI Pharmaceuticals, Inc.
99.2		ANI Pharmaceuticals, Inc. Corporate Presentation, May 2015

  

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	ANI PHARMACEUTICALS, INC.
	By:	/s/ Charlotte C. Arnold
		Charlotte C. Arnold
		Vice President, Finance and Chief Financial Officer
Dated:  May 15, 2015

 

 

Exhibit 99.2

 

 

A Specialty Pharmaceutical Company NASDAQ: ANIP GENERIC AND BRANDED PRESCRIPTION DRUG PRODUCTS Corporate Presentation May 2015

Forward - Looking Statements To the extent any statements made in this presentation deal with information that is not historical, these are forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about price increases, the Company’s future operations, products financial position, operating results and prospects , the Company’s pipeline or potential markets therefore, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates. Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward - looking statements. Uncertainties and risks include, but are not limited to, the risk that the Company may face with respect to importing raw materials; increased competition; delays or failure in obtaining product approval from the U.S. Food and Drug Administration; general business and economic conditions; market trends; products development; regulatory and other approvals and marketing. More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10 - K and quarterly reports on Form 10 - Q, as well as its proxy statement. All forward - looking statements in this presentation speak only as of the date of this presentation and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward - looking statement, whether as a result of new information, future events or otherwise. 2

3 ANI Mission Statement ANI Pharmaceuticals is an integrated specialty pharmaceutical company developing, manufacturing and marketing branded and generic prescription pharmaceuticals. ANI’s mission is to develop, manufacture, and market niche generic pharmaceuticals, focusing on opportunities in pain management (narcotics), anti - cancer (oncolytics), women’s health (hormones and steroids), and complex formulations including extended release and combination products.

ANI Overview – Positioned for Growth ANI Today ▪ Current business – For the quarter ended March 31, 2015: $18.8 million total net revenues □ $12.3 million Generic Rx product revenues +52% y/y □ $4.3 million Brand Rx product revenues +452% y/y □ $2.3 million c ontract manufacturing/services revenues +10% y/y □ Growth of 72.5% quarter/quarter ▪ Guidance for 2015 (1) – Net revenues of $80 million to $88 million – Adjusted non - GAAP EBITDA of $48.8 to $53.1 million – Adjusted non - GAAP diluted earnings per share of $2.44 to $2.67 ▪ 47 products in development; total current market $3.3 billion (2) ▪ $166 million in cash for accretive acquisitions (1) May 5, 2015 press release (2) Based on Company estimates, and recent IMS and NSP Audit data 4

5 ANI History and Highlights 2013 Completed merger with BioSante Pharmaceuticals and obtains NASDAQ Global Market listing (NASDAQ: ANIP), June 2013 2013 Announced agreement to acquire 31 previously marketed generic products from Teva for $12.5 million and a percentage of future gross profits, December 2013 2014 Closed public offering of common shares netting $46.8 million, March 2014 2014 Acquired Vancocin ® and related assets for $11 million, August 2014 2014 Closed public offering of $143.8 million of convertible debt with simultaneous bond hedge and warrant transactions, December 2014 2014 Acquired Lithobid ® for $12 million, July 2014 2014 Launched Methazolamide Tablets, first product from portfolio of approved generic products acquired from Teva, November 2014 2015 Acquired approved NDA for Testosterone Gel from Teva , May 2015 2015 Acquired approved ANDA for Flecainide tablets from Teva , March 2015 2015 Launched Etodolac Capsules and Propafenone Tablets from portfolio of approved generic products acquired from Teva, March 2015

6 Sales and Marketing / Financial Overview

ANI Financial Highlights 7 First Quarter 2015 Results ($ in millions) Quarter ended March 31, 2015 March 31, 2014 % Growth Net revenues $18.8 $10.9 72% Adjusted non - GAAP EBITDA (1) $11.5 $ 4.2 170% (1) Please see page 19 for US GAAP reconciliation (2) Please see page 20 for US GAAP reconciliation 2014 Results ($ in millions, except earnings per share) Year ended Dec 31, 2014 Dec 31, 2013 % Growth Net Revenues $56.0 $30.1 86% Adjusted non - GAAP EBITDA (2) $27.3 $7.5 264%

ANI Historical Revenue Growth 8 $s in millions 39% C ost of sales as a percentage of net revenues, excluding depreciation and amortization 42% 43% 33% 21% 15%

ANI Generic Rx Product Portfolio Generic Products Market Share (1) Competitors EE/MT Tablets 49% 2 Fluvoxamine Tablets 55% 2 HC Enema 90% 1 Metoclopramide Solution 29% 2 Opium Tincture 73% 2 Methazolamide Tablets (2) 8% 2 Etodolac Capsules launched March 2015 2 Propafenone Tablets launched March 2015 3 9 (1) Based on Company estimates, and recent IMS and NSP Audit data (2) Launched November 2014 1Q 2015 Net Sales: $12.3M

ANI Brand Rx Product Portfolio 10 Lithobid ® Tablets Bipolar Disorder Vancocin ® Capsules C. difficile - Associated Diarrhea Cortenema ® U lcerative Colitis Reglan ® Gastroesophageal Reflux 1Q 2015 Net Sales: $4.3M

ANI Contract Manufacturing and Other 11 Current Business ▪ Four customers – Eight products and nineteen SKUs – Contract manufacturing and contract packaging ▪ Royalty income from authorized generic of Vancocin ® capsules 1Q 2015 Net Sales: $2.3M

12 Product Development / Business Development Overview

13 ANI Product Development Pipeline 47 p roducts in development, total combined current market: $3.3 billion (1) Key Products: – Oral Anti - Cancer: Expedited review granted by FDA; no generics; exclusive API source; once approved potentially only generic player – Lansoprazole ODT: Approved ANDA acquired from Teva ; no generics; OB - listed patents expire 2019; requires Prior Approval Supplement filing -- Reformulation and BE study 2014 IMS indicates $220M market (1) – Testosterone Gel: Approved NDA, (not AB - rated to Androgel ® ); limited competition market; target launch 2016; 2014 IMS indicates $300M market (1) (1) Based on Company estimates, and recent IMS and NSP Audit data

14 ANI Business Development Highlights Acquired approved NDA for Testosterone gel, May 2015 Acquired approved ANDA for Flecainide tablets, March 2015 Acquired Vancocin ® and related assets, August 2014 Acquired Lithobid ® , July 2014 Acquired 31 generic products, December 2013 Acquired Reglan ® tablets, June 2011 Business Development Focus In - licensing/acquisitions/alliances for development stage ANDAs, revenue generating products Enhancing generic product pipeline through development partnerships Company acquisitions

15 Manufacturing Overview

16 ANI Manufacturing – Main Street Facility Location: Baudette , Minnesota ▪ 52,000 square feet of manufacturing , packaging, and warehouse facilities ▪ Rx solutions , suspensions , topicals , tablets , and capsules ▪ DEA - licensed for Schedule II controlled substances ▪ 17,000 square feet of laboratory space for product development and analytical testing

17 ANI Manufacturing – IDC Road Facility Location: Baudette, Minnesota ▪ Fully - contained h igh potency facility with capabilities to manufacture h ormone , steroid , and oncolytic products ▪ 47,000 square feet of manufacturing and packaging, and warehouse facilities ▪ 100 nano - gram per eight - hour weighted average maximum exposure limit to ensure employee safety ▪ DEA Schedule IIIN capability

ANI Summary ANI is an integrated specialty generic pharmaceutical firm with: ▪ Profitable base business generating organic growth – 2015 Annual guidance (1) □ Net revenues of $80 million to $88 million □ Adjusted non - GAAP EBITDA of $48.8 million to $53.1 million □ Adjusted non - GAAP EPS of $2.44 to $2.67 ▪ Well capitalized balance sheet with $166 million in cash ▪ Experienced management team ANI is focused on: ▪ Internal product development ▪ Partnerships/strategic alliances ▪ Accretive acquisitions 18 (1) May 5, 2015 press release

U.S. GAAP Reconciliations 19 2015 2014 Operating Income $9,567 $3,495 Add back Depreciation and amortization 1,327 703 Add back Stock-based compensation 568 47 Adjusted EBITDA $11,462 $4,245 ANI Pharmaceuticals, Inc. and Subsidiary Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation (unaudited, in thousands) Three months ended March 31,

U.S. GAAP Reconciliations 20 2014 2013 Operating Income $20,006 $898 Add back Depreciation and amortization 3,878 1,110 Add back Stock-based compensation 3,423 36 Merger-related expenses, not already added back Adjusted EBITDA $27,307 $7,512 5,468 - ANI Pharmaceuticals, Inc. and Subsidiary Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation (unaudited, in thousands) Year ended December 31,