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):  March 9, 2016

 

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:

 

o

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

 

o

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

 

o

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

 

o

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

 

 

Item 7.01

Regulation FD Disclosure.

 

On March 9, 2016, ANI Pharmaceuticals, Inc. (the “Company,” “we” or “us”) announced that Arthur S. Przybyl, President and CEO, will present at the 28th Annual ROTH Conference, which presentation will be webcast live at http://wsw.com/webcast/roth30/anip at 11:30 AM PT on Monday, March 14, 2016. The live webcast will be archived and available for 90 days, through June 12, 2016.

 

On March 9, 2016, we posted to our website our March 2016 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 risks that we may face with respect to importing raw materials, acquisitions, 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 March 9, 2016, issued by ANI Pharmaceuticals, Inc.
99.2		ANI Pharmaceuticals, Inc. Corporate Presentation, March 2016

 

 

 

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:  March 9, 2016

 

 

 

Exhibit 99.2

 

A Specialty Pharmaceutical Company NASDAQ: ANIP GENERIC AND BRANDED PRESCRIPTION DRUG PRODUCTS Corporate Presentation March 2016

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; acquisitions; 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. We focus on niche and high barrier to entry opportunities including controlled substances, anti - cancer (oncolytics), hormones and steroids, and complex formulations.

ANI Overview – Positioned for Growth ANI Today ▪ Current business – For the year ended December 31, 2015: $76.3 million total net revenues □ $55.2 million Generic Rx product revenues □ $11.0 million Brand Rx product revenues □ $10.1 million c ontract manufacturing/services revenues □ Growth of 36% year/year ▪ Guidance for 2016 (1) – Net revenues of $105 million to $120 million – Adjusted non - GAAP EBITDA (2) of $45 to $53 million – Adjusted non - GAAP net income per diluted share (2) of $2.94 to $3.31 ▪ 85 products in development; total current market $4.5 billion (3) (1) February 23, 2016 press release (2) See Appendix A for US GAAP reconciliations (3) Based on Company estimates, and recent IMS and NSP Audit data 4

5 ANI Acquisition Highlights 2013 Completed merger with BioSante Pharmaceuticals and obtains NASDAQ Global Market listing (NASDAQ: ANIP), June 2013 2014 Acquired 31 previously marketed generic products from Teva for $12.5 million and a percentage of future gross profits, January 2014 2014 Acquired Lithobid ® for $12 million, July 2014 2015 Acquired approved NDA for Testosterone Gel from Teva , May 2015 2014 Acquired Vancocin ® and related assets for $11 million, August 2014 2015 Acquired approved ANDA for Flecainide tablets from Teva for $4.5 million and a percentage of future gross profits, March 2015 2016 Acquired exclusive rights to market three products and an early stage development injectable product from H2 - Pharma for $10 million, January 2016 2016 Acquired two NDAs for Corticotrophin from Merck for $75 million and a percentage of future net sales, January 2016 2015 Acquired 22 previously marketed generic products from Teva for $25 million and a percentage of future gross profits, July 2015

6 Sales and Marketing Overview

ANI Revenue Growth 7 $s in millions 39% C ost of sales as a percentage of net revenues, excluding depreciation and amortization 42% 43% 33% 21% 20%

ANI Generic Rx Product Portfolio Generic Products Market Share (1) Competitors (2) EE/MT Tablets 50% 3 Fluvoxamine Tablets 56% 3 HC Enema 90% 2 Metoclopramide Solution 26% 2 Opium Tincture 70% 3 Methazolamide Tablets 29% 3 Etodolac Capsules 21% 3 Propafenone Tablets 5% 4 Oxycodone Solution Launched 10/15 4 Vancomycin Capsules Launched 11/15 6 Nimodipine Capsules Launched 12/15 3 Flecainide Tablets Launched 12/15 5 8 (1) Based on Company estimates, and recent IMS and NSP Audit data (2) Including ANI 2015 Net Sales: $55.2M

ANI Brand Rx Product Portfolio 9 Lithobid ® Tablets Bipolar Disorder Vancocin ® Capsules C. difficile - Associated Diarrhea Cortenema ® U lcerative Colitis Reglan ® Gastroesophageal Reflux 2015 Net Sales: $11.0M

ANI Contract Manufacturing and Other 10 Current Business ▪ Four customers – Seven products and seventeen SKUs – Contract manufacturing and contract packaging 2015 Net Sales: $10.1M

11 Business Development / Product Development Overview

Business Development Activity 12 $1.1 $0.1 G e n e r i c s DONEPEZIL (Partnership with Dexcel) FDF Partnership Private P TEVA ANDA BASKET 2 (22 previously approved ANDAs) TEVA ANDA BASKET 1 (31 previously approved ANDAs) Total $152.2 FDF Partnership Private Acquisition Public P P P $25.0 P $12.5 Acquisition Public P P Acquisition Private P P P $4.5 US Distribution Rights Private P P FLECAINIDE (flecainide tablets) P Acquisition US Distribution Rights Private P P $1.0 IDT Partnership (18 previously approved ANDAs) P P $12.0 NIMODIPINE & GENERIC PRODUCT (Partnership with Sofgen) VANCOCIN (vancomycin hydrochloride capsules) LITHOBID (lithium carbonate tablets) Acquisition Private Acquisition Private P P $11.0 P $0.0 Acquisition Private P $10.0 H2-Pharma (Lipofen AG, 1% & 2.5% HC Cream) $75.0 TESTOSTERONE GEL (testosterone gel satchets) ACQUISITION COST ($M) B r a n d s Acquisition Public P P CORTICOTROPIN DEAL STRUCTURE DEAL SOURCE STRATEGY STATEMENT ANI MANUFACTURED PREVIOUSLY APPROVED (corticotropin)

13 ANI Product Development Pipeline 85 p roducts in development, total combined current market: $4.5 billion (1) ▪ 57 products were acquired and of those, ANI believes 48 can be commercialized based on either a CBE - 30 or PAS ▪ ANI anticipates launching 12 products by the end of 2016: (1) Based on Company estimates, and recent IMS and NSP Audit data (2) FDA’s Revised Target Action Date, per FDA communications Product Total Annual Market Size (1) Estimated Launch FDA Approvals Required Hydrocortisone rectal cream, 1% and 2.5% $73M Q2 2016 Approved Anti - cancer drug, ( TAD (2) 6/7/2016 ) Undisclosed Q2 2016 ANDA Dexcel product $ 44M Q3 2016 Approved Anti - infective $69M Q3 2016 CBE - 30 Three IDT products $97M Q3 2015 CBE - 30s Four C - II products $46M Q4 2016 ANDAs

14 Manufacturing Overview

15 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

16 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 – 2016 Annual guidance (1) □ Net revenues of $105 million to $120 million □ Adjusted non - GAAP EBITDA of $45 million to $53 million □ Adjusted non - GAAP Net Income Per Diluted Share of $2.94 to $3.31 ▪ Well capitalized balance sheet with $75 million in cash ▪ Experienced management team ANI is focused on: ▪ Partnerships/strategic alliances ▪ Accretive acquisitions ▪ Internal product development 17 (1) February 23, 2016 press release

18 Appendix A

U.S. GAAP Reconciliations 19 2015 2014 2015 2014 Operating Income $6,268 $10,772 $32,700 $20,006 Add back Depreciation and amortization 2,111 1,282 6,900 3,878 Add back Stock-based compensation 1,139 704 3,856 3,423 Adjusted non-GAAP EBITDA $9,518 $12,758 $43,456 $27,307 ANI Pharmaceuticals, Inc. and Subsidiaries Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation (unaudited, in thousands) Three months ended December 31, Year ended December 31,

U.S. GAAP Reconciliations 20 2015 2014 2015 2014 Net Income 2,876$ 21,006 $ 15,375 $ 28,747 Add back Tax provision 625 (10,946) 6,358 (9,368) Depreciation and amortization expense 2,111 1,282 6,900 3,878 Non-cash interest expense 1,722 560 6,831 560 Stock-based compensation 1,139 704 3,856 3,423 Excess of Fair Value over Cost of Acquired Inventory - 10 - 29 Less Current portion of tax provision (2,431) (3,163) (7,875) (4,307) Adjusted non-GAAP Net Income 6,042$ 9,453$ 31,445$ 22,962$ Diluted Weighted-Average Shares Outstanding 11,552 11,476 11,557 11,053 Adjusted non-GAAP Net Income Per Diluted Share 0.52$ 0.82$ 2.72$ 2.08$ Year ended December 31, ANI Pharmaceuticals, Inc. and Subsidiaries Adjusted non-GAAP Net Income and Adjusted non-GAAP Net Income per Diluted Share Reconciliation (unaudited, in thousands, except per share amounts) Three months ended December 31,