UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 10, 2013
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 December 10, 2013, ANI Pharmaceuticals, Inc. (the “Company”) announced that Arthur S. Przybyl, President and CEO, had presented at the Oppenheimer & Co. 24th Annual Healthcare Conference, which presentation was webcast live at http://www.veracast.com/webcasts/opco/healthcare2013/64116492475.cfm. The live webcast was archived and will be available for 90 days through March 10, 2014.
On December 10, 2013, the Company posted to its website its December 2013 Corporate Presentation. The presentation is available on the Company's 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 under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the Company’s plans, objectives, expectations and intentions with respect to future operations and products, the anticipated financial position, operating results and growth prospects of the Company 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. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. 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 the risk that the Company may in the future be required to seek FDA approval for its unapproved products or withdraw such products from the market; the Company may in the future fail to meet NASDAQ listing requirements; general business and economic conditions; the Company’s need for and ability to obtain additional financing; the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; and the marketing success of the Company’s licensees or sublicensees. 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 report on Form 10-Q, as well as its proxy statement/prospectus, filed with the Securities and Exchange Commission on May 8, 2013. All forward-looking statements in the presentation slides speak only as of the date made and are based on the Company’s current beliefs 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.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| No. | Description | |
| 99.1 | Press release, dated December 10, 2013, issued by ANI Pharmaceuticals, Inc. | |
| 99.2 | ANI Pharmaceuticals, Inc. Corporate Presentation December 2013 |
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 and Chief Financial Officer | ||
| Dated: December 10, 2013 | ||
| FOR IMMEDIATE RELEASE | NASDAQ: ANIP |
ANI Pharmaceuticals Presents At Oppenheimer 24th Annual Healthcare Conference
BAUDETTE, Minnesota (December 10, 2013) – ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) presented at the Oppenheimer & Co. 24th Annual Healthcare Conference at the Crowne Plaza Hotel in New York City. On December 10, 2013 at 4:30pm, Arthur S. Przybyl, President and CEO, gave the presentation, which was webcast live at http://www.veracast.com/webcasts/opco/healthcare2013/64116492475.cfm. The live webcast was archived and will be available through the prior link for 90 days through March 10, 2014.
About ANI
ANI is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. In two facilities with combined manufacturing, packaging and laboratory capacity totaling 173,000 square feet, ANI manufactures oral solid dose products, as well as liquids and topicals, including narcotics and those that must be manufactured in a fully contained environment due to their potency and/or toxicity. ANI also performs contract manufacturing for other pharmaceutical companies. Over the last two years ANI has launched three new products and has twelve products in development. ANI’s targeted areas of product development include narcotics, anti-cancers and hormones (potent compounds), and extended release niche generic product opportunities. ANI’s other products include an FDA-approved testosterone gel, which is licensed to Teva Pharmaceuticals USA. For more information please visit our website www.anipharmaceuticals.com.
Forward-Looking Statements
To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the potential benefits of the merger, the combined company’s plans, objectives, expectations and intentions with respect to future operations and products, the anticipated financial position, operating results and growth prospects of the combined company 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. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause the combined company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include the risk that the Company may in the future be required to seek FDA approval for its unapproved products or withdraw such products from the market; the Company may fail to meet NASDAQ listing requirements; general business and economic conditions; the Company’s need for and ability to obtain additional financing; the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; and the marketing success of the Company’s licensees or sublicensees. 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 this quarterly report on Form 10-Q, as well as its proxy statement/prospectus, filed with the Securities and Exchange Commission on May 8, 2013. All forward-looking statements in this release speak only as of the date made and are based on the Company’s current beliefs 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.
For more information about ANI, please contact:
Arthur S. Przybyl
(218) 634-3608
arthur.przybyl@anipharmaceuticals.com
A Specialty Pharmaceutical Company NASDAQ: ANIP HIGH POTENCY DRUGS – NARCOTIC DRUGS – RX LIQUIDS AND TABLETS – CONTRACT MANUFACTURING Corporate Presentation December 2013
2 Cautionary Statement Concerning Forward - Looking Statements This presentation and certain information incorporated herein by reference contain forward - looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the Company’s plans, objectives, expectations and intentions with respect to future operations and products, the anticipated financial position, operating results and growth prospects of the Company 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. Forward - looking statements by their nature address matters that are, to different degrees, uncertain. 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 the risk that the Company may in the future be required to seek FDA approval for its unapproved products or withdraw such products from the market; the Company may in the future fail to meet NASDAQ listing requirements; general business and economic conditions; the Company’s need for and ability to obtain additional financing; the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; and the marketing success of the Company’s licensees or sublicensees . 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 report on Form 10 - Q, as well as its proxy statement/prospectus, filed with the Securities and Exchange Commission on May 8, 2013. All forward - looking statements in this presentation speak only as of the date made and are based on the Company’s current beliefs 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 3 ANI Mission Statement ANI Pharmaceuticals is an emerging specialty pharmaceutical company developing, manufacturing and marketing branded and generic prescription pharmaceuticals. ANI’s mission is to 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.
4 ANI Overview – Poised for Growth ANI Today ▪ Core competencies: marketing and manufacturing ▪ Two manufacturing facilities: narcotics and potent compounds ▪ Experienced management team ▪ Existing business + potential future royalty stream – For the nine - month period ended Sept. 30, 2013 (1) : $19.5M total revenues □ $13.8 million ANI Rx product revenues □ $5.7 million c ontract m anufacturing revenues □ Annual organic growth 56% year/year – Potential future royalty stream via partnership with Teva – 12 products in development; total current market $850 million (2) ▪ Well - capitalized balance sheet: $13 million cash / no debt (1) Unaudited (2) Based on Company estimates, and recent IMS and NSP Audit data 4
5 5 ANI Recent History and Highlights 2009 New executive management team: Art Przybyl, CEO and Charlotte Arnold, CFO 2010 New management expands ANI strategy to include ANI labeled Rx products 2011 ANI expands marketed Rx portfolio to seven products through internal development and acquisition 2013 ANI completes merger with BioSante Pharmaceuticals and obtains NASDAQ Global Market listing (NASDAQ: ANIP), June 2013 Summary of BioSante Transaction • Acquires potential future royalty on generic Androgel ™ via Teva partnership • Transaction nets $18M in cash • Public listing enables easier access to markets for future expansion • ANI Shareholders own 57% of company post - merger • Acquires Libigel ™ intellectual property and clinical package
6 6 Sales and Marketing / Financial Overview
7 $9 $17 $20 $20 $28.6 $0 $5 $10 $15 $20 $25 $30 2010 2011 2012 2013 2013E ANI Historical Revenue Growth 7 $s in millions +30% Year/Year growth 39% 42% 43% 34% C ost of sales as a percentage of net revenues, excluding depreciation and amortization 1 (1) Unaudited (1Q – 3Q) (Guidance)
8 ANI Current Rx Product Portfolio Market Generic Products Position Share (1) EE/MT Tablets #1 92% Fluvoxamine Tablets #1 54% HC Enema #1 85% Metoclopramide Solution #2 31% Opium Tincture #1 75% 8 Branded Products Cortenema TM Reglan Tablets TM (1) Based on Company estimates, and recent IMS and NSP Audit data
9 ANI Rx Portfolio Prescription Volumes 9 Source: IMS Health 0 5,000 10,000 15,000 20,000 25,000 30,000
10 ANI Contract Manufacturing and Royalties 10 Current Business ▪ $5.7 million in contract manufacturing and services revenues during the nine - month period ended Sept. 30, 2013 (1) ▪ Five customers – Eleven products and fourteen SKUs Future Opportunities ▪ Three customers in development – Three products and seven SKUs ▪ Potential future royalty: Teva’s generic Androgel ™ (1) Unaudited
11 ANI 3Q 2013 Financial Highlights 11 4Q13 Guidance $9M+ in revenues representing 15% sequential growth source: 3Q13 press release ($ in millions) Three months ended September 2013 September 2012 Net Revenues $7.8 $5.0 Adjusted EBITDA $1.7 $0.3 Adjusted EPS $0.16 n/a Select Balance Sheet Data September 2013 December 2012 Cash $10.9 $.01 Restricted Cash $2.3 $0 Total Current Assets $26.1 $8.6 Current Liabilities $6.6 $7.7 Current Ratio 4.0 1.1
12 12 Product Development / Business Development Overview
13 13 ANI Product Development Highlights 12 p roducts in development ▪ Five filed ANDAs ▪ Seven ANDAs in progress – Development partners: Ricon and Sofgen ▪ Total combined current market: $850 million (1) Therapeutic Category Filed In Development Market Size (1) ($ in millions) Oncolytics and Narcotics 3 2 $97 million Other (e.g. Extended Release, Combination Products) 2 5 $753 million (1) Based on Company estimates, and recent IMS and NSP Audit data
14 14 ANI Business Development Highlights Acquired undisclosed A NDA, March 2010 Acquired Reglan TM tablets, June 2011 Product development partnership with Ricon , June 2011 Acquired royalty arrangement with Teva , June 2013 Product development partnership with Sofgen , August 2013 Business Development Focus Enhancing generic product pipeline through development partnerships Acquiring / In - licensing approved or development stage ANDAs Acquiring revenue generating products / companies
15 15 Manufacturing Overview
16 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 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
18 ANI Summary ANI is an emerging specialty/generic pharmaceutical firm with: ▪ Profitable base business generating organic growth ▪ Well capitalized balance sheet ▪ Experienced management team ANI is focused on: ▪ Internal product development ▪ Partnerships/strategic alliances ▪ Accretive acquisitions 18