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): April 1, 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:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 2.01. | Completion of Acquisition or Disposition of Assets. |
On April 1, 2016, ANI Pharmaceuticals, Inc.
(the “Company” or “ANI”) and Cranford Pharmaceuticals, LLC (“Cranford”) completed the previously
announced acquisition of certain assets (the “Acquisition”) pursuant to the Asset Purchase Agreement, dated March 10,
2016 between ANI and Cranford (the “Agreement”). Pursuant to the Agreement, the Company acquired Cranford's right, title
and interest in the NDA for Inderal® LA (the “NDA”) and certain documentation, trademark rights and finished goods
inventory relating to the NDA (the “Acquired Assets”).
In consideration for the purchase of the Acquired Assets, the Company paid Cranford an aggregate purchase price of $60 million and will pay to Cranford certain annual milestone payments.
A press release announcing the closing of the Acquisition is filed with this Current Report on Form 8-K as Exhibit 99.1 and incorporated into this Item 2.01 by reference.
| Item 8.01. | Other Events. |
On April 4, 2016, the Company issued a press release announcing revised financial guidance for 2016 to reflect the closing of the Acquisition. The press release, filed with this Current Report on Form 8-K as Exhibit 99.2, is incorporated into this Item 8.01 by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| No. | Description | |
| 99.1 | Press release, dated April 4, 2016, announcing the closing of the Acquisition. | |
| 99.2 | Press release, dated April 4, 2016, announcing revised financial guidance for 2016. |
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: April 4, 2016 | ||
ANI Pharmaceuticals Closes Acquisition of Inderal® LA Assets
BAUDETTE, Minn., April 4, 2016 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has completed the acquisition of the portfolio of Inderal® LA assets from Cranford Pharmaceuticals, LLC. As previously communicated, the acquired portfolio includes the NDA and trademark for Inderal® LA as well as finished goods inventory. The acquisition was funded through cash on hand.
In conjunction with today's announcement, ANI has immediately begun selling both Inderal® LA 60mg, 80mg, 120mg and 160mg sustained release capsules as well as the authorized generic propranolol ER 60mg, 80mg, 120mg and 160mg sustained release capsules under their current labels. ANI will transition both products to the ANI label at a future date.
Arthur S. Przybyl, ANI's President and CEO stated, "We are excited to have closed this acquisition that meaningfully expands ANI's commercial portfolio."
About Inderal® LA capsules
Hypertension
Inderal® LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal® LA is not indicated in the management of hypertensive emergencies.
Angina Pectoris Due to Coronary Atherosclerosis
Inderal® LA is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.
Migraine
Inderal® LA is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use.
Hypertrophic Subaortic Stenosis
Inderal® LA improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
About ANI
ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The Company's targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products. 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 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 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 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 news release speak only as of the date of this news release 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.
For more information about ANI, please contact:
Investor Relations
IR@anipharmaceuticals.com
ANI Pharmaceuticals Updates 2016 Financial Guidance
BAUDETTE, Minn., April 4, 2016 /PRNewswire/ -- As a result of the close of the acquisition of the Inderal® LA assets from Cranford Pharmaceuticals, ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today issued revised financial guidance for 2016.
|
| Revised Guidance | Original Guidance |
Net Revenues |
$119 million to $134 million | $105 million to $120 million |
Adjusted non-GAAP EBITDA |
$55 million to $63 million
| $45 million to $53 million |
Adjusted non-GAAP Net Income Per Diluted Share | $3.54 to $3.91 | $2.94 to $3.31 |
Arthur S. Przybyl, ANI's President and CEO stated, "The close of this transaction to acquire Inderal LA and Propranolol ER kicks off a busy and exciting second quarter for ANI. In total, we expect to launch seven products over this time frame including Inderal LA and Propranolol ER capsules, hydrocortisone cream 1% and 2.5% for rectal use, a previously unannounced authorized generic product, our generic anti-cancer product (pending FDA approval) and fenofibrate 50mg and 150mg capsules in the ANI label. These seven products have a combined market value of $342M on a trailing twelve month basis, per IMS Health."
About ANI
ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The Company's targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products. For more information, please visit our website www.anipharmaceuticals.com.
Non-GAAP Financial Measures
Certain elements of the Company's fiscal 2016 guidance have been provided on a non-GAAP basis. This is due to the inherent difficulty of forecasting the timing or amount of items that would be included in the most directly comparable forward-looking GAAP financial measures. Because a reconciliation is not available without unreasonable effort, it is not included in this release.
Forward-Looking Statements
To the extent any statements made in this release 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 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 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 news release speak only as of the date of this news release 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.
For more information about ANI, please contact:
Investor Relations
IR@anipharmaceuticals.com