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): November
7, 2016
ARIAD
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
001-36172 |
22-3106987 |
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
26 Landsdowne Street, Cambridge, Massachusetts |
02139 |
(Address of principal executive offices) |
(Zip Code) |
Registrant's telephone number, including
area code: (617) 494-0400
Not
Applicable
(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 (see General Instruction A.2. below):
⃞ 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 2.02 Results of Operations and Financial Condition.
In a press release dated November 7, 2016, ARIAD Pharmaceuticals, Inc. (the “Company”) announced financial results for the third quarter and nine months ended September 30, 2016, provided an update on corporate developments and reaffirmed 2016 financial guidance. A copy of the press release is attached hereto as Exhibit 99.1. The information under the headings “Financial Results for the Quarter and Nine Months Ended September 30, 2016” (other than the information under “2016 Financial Guidance”), “Today’s Conference Call at 8:30 a.m. ET” and the condensed consolidated financial information included in the press release are incorporated by reference into this Item 2.02 of this Current Report on Form 8-K.
ITEM 5.08 Shareholder Director Nominations.
The 2017 Annual Meeting of Stockholders of the Company (the “2017 Annual Meeting”) will be held on May 16, 2017. In accordance with the Company’s Amended and Restated Bylaws, and the applicable rules and regulations of the Securities and Exchange Commission (the “SEC”), the Company is reporting a new deadline for the submission of shareholder proposals for the 2017 Annual Meeting because the date of the 2017 Annual Meeting is more than 30 calendar days prior to the anniversary of the Company’s 2016 Annual Meeting of Stockholders, which was held on July 21, 2016.
Because the 2017 Annual Meeting will be advanced more than 30 days from the anniversary date of the Company's 2016 Annual Meeting of Stockholders, the deadline for stockholder proposals for consideration at the 2017 Annual Meeting set forth in the Company's definitive proxy statement filed with the SEC on June 8, 2016 no longer applies. Any stockholder proposal intended for inclusion in our proxy materials for the 2017 Annual Meeting should be sent to our Secretary and must be received by us at our offices at 26 Landsdowne Street, Cambridge, Massachusetts 02139-4234, by December 31, 2016.
If a stockholder intends to present a proposal at the 2017 Annual Meeting without including it in our proxy materials, including any notice on Schedule 14N, that stockholder must comply with the advance notice provisions of our Amended and Restated Bylaws. Those provisions require that we receive the proposal at our offices at 26 Landsdowne Street, Cambridge, Massachusetts 02139-4234, attention Corporate Secretary, not earlier than December 17, 2016 and not later than the close of business on March 17, 2017.
ITEM 7.01 Regulation FD Disclosure.
In the press release dated November 7, 2016, the Company also reaffirmed 2016 financial guidance and provided information on upcoming financial and medical meetings. The information set forth under the headings “2016 Financial Guidance” and “Upcoming Meetings” in the press release is incorporated by reference into this Item 7.01 of this Current Report on Form 8-K.
ITEM 8.01 Other Events.
In the press release dated November 7, 2016, the Company also provided
an update on its Iclusig®, brigatinib and pipeline programs and other
recent developments. The second paragraph of the press release and the
information set forth under the headings “Recent Progress and Key
Objectives” and “Recent Event,” together with the forward-looking
statement disclaimer at the end of the press release, are incorporated
by reference into this Item 8.01 of this Current Report on Form 8-K.
ITEM
9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
Description |
|
99.1 | Press release dated November 7, 2016 |
The press release may contain hypertext links to information on our websites. The information on our websites is not incorporated by reference into this Current Report on Form 8-K and does not constitute a part of this Form 8-K.
The portions of the press release incorporated by reference into Item 8.01 of this Current Report on Form 8-K are being filed pursuant to such item. The remaining portions of the press release are being furnished pursuant to Items 2.02 and 7.01 of this Current Report on Form 8-K and shall not be deemed “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, nor shall they be deemed incorporated by reference in any filing 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.
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 hereunto duly authorized.
ARIAD Pharmaceuticals, Inc. |
|||||
|
|
By: |
/s/ Manmeet S. Soni |
||
Manmeet S. Soni |
|||||
Executive Vice President, Chief Financial Officer |
|||||
Date: |
November 7, 2016 |
Exhibit List.
Exhibit |
Description |
|
99.1 |
Press release dated November 7, 2016 |
4
Exhibit 99.1
ARIAD Reports Third Quarter 2016 Financial Results
~Brigatinib granted Priority Review with a PDUFA date of April 29, 2017
~ Regulatory approval of Iclusig® in Japan
~ Enrollment continues in OPTIC, OPTIC-2L, ALTA-1L, AP32788 trials highlighting ARIAD's continued R&D investment for patients with rare cancers
~ U.S. product revenue of $33.6 million for the quarter (~66% growth from prior year)
~ Net loss for the quarter of $27.8 million
~Conference call scheduled today at 8:30 a.m. ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--November 7, 2016--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the third quarter and first nine months of 2016. The Company also provided an update on corporate developments and reaffirmed 2016 financial guidance.
“During the third quarter, ARIAD achieved several important milestones that further our commitment as a small, research-based biotechnology company to patients with rare cancers, including those with no other targeted treatment options available,” said Paris Panayiotopoulos, president and chief executive officer of ARIAD. “Iclusig was approved in Japan and we received priority review from the FDA for brigatinib in crizotinib-treated ALK+ non-small cell lung cancer. We are continuing to invest heavily in R&D and to progress in enrolling in the OPTIC, OPTIC-2L and ALTA-1L trials for Iclusig and brigatinib, as well as our clinical trial for AP32788, a novel kinase inhibitor for a rare form of lung cancer involving mutations in the EGFR and HER2 genes, and for which there are currently no approved targeted treatments.”
Financial Results for the Quarter and Nine Months Ended September 30, 2016
Revenue
GAAP and Non-GAAP Net Income (Loss)
GAAP net loss for the quarter ended September 30, 2016 was $27.8 million, or $0.14 per basic and diluted share, respectively, compared to GAAP net loss of $55.5 million, or $0.29 loss per basic and diluted share, for the quarter ended September 30, 2015. GAAP net income for the nine months ended September 30, 2016 was $28.2 million, or $0.15 per basic share and $0.14 per diluted share, compared to GAAP net loss of $171.3 million, or $0.91 loss per basic and diluted share, for the nine months ended September 30, 2015. During the nine months ended September 30, 2016, the Company recorded a $129.0 million gain related to the Incyte transaction under other income (expense), net related to closing the sale of the Company’s European operations and out-license of Iclusig rights in Europe.
Non-GAAP net loss for the quarter ended September 30, 2016 was $22.5 million, or $0.12 per diluted share, compared to non-GAAP net loss of $45.5 million, or $0.24 per diluted share for the quarter ended September 30, 2015. Non-GAAP net income for the nine months ended September 30, 2016 was $47.4 million, or $0.24 per diluted share, compared to non-GAAP net loss of $142.3 million, or $0.75 per diluted share, for the nine months ended September 30, 2015.
Non-GAAP net loss excludes stock-based compensation, restructuring charges for a reduction in force in March 2016 and transaction costs for the Incyte transaction. See “Use of Non-GAAP Financial Measures” below for a description of non-GAAP financial measures and the reconciliation between GAAP and non-GAAP measures at the end of this press release.
Operating Expenses
Other income (expense), net
Cash Position
PDL Royalty Financing and Convertible Notes 2019
2016 Financial Guidance
Recent Progress and Key Objectives
Iclusig
Brigatinib
Advancing the Pipeline
Upcoming Meetings
Recent Event
Today’s Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our third quarter and first nine months 2016 financial results this evening at 8:30 a.m. ET, at which we will also provide an update on corporate developments. The live webcast can be accessed by visiting the investor relations section of the Company’s website at http://investor.ariad.com. The call can be accessed by dialing 844-249-9386 (domestic) or 270-823-1534 (international) five minutes prior to the start time and providing the pass code 99997465. A replay of the call will be available on the ARIAD website approximately two hours after completion of the call and will be archived for three weeks.
About Iclusig® (ponatinib) tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.
Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel, Canada and Japan.
In the U.S., Iclusig is a kinase inhibitor indicated for the:
These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.
Limitations of use:
Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML.
IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY
See full prescribing information for complete boxed warning
Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information.
Iclusig is a registered trademark of ARIAD Pharmaceuticals, Inc.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is focused on discovering, developing and commercializing precision therapies for patients with rare cancers. ARIAD is working on new medicines to advance the treatment of rare forms of chronic and acute leukemia, lung cancer and other rare cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).
Use of Non-GAAP Financial Measures
This press release contains non-GAAP financial measures, including costs and expenses and other expenses adjusted to exclude certain cash and non-cash expenses. These measures are not in accordance with, or an alternative to, generally accepted accounting principles, or GAAP, and may be different from non-GAAP financial measures used by other companies.
The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures for the periods presented in this press release are:
The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding various financial and business trends relating to our financial condition and results of operations. When GAAP financial measures are viewed in conjunction with non-GAAP financial measures, investors are provided with a more meaningful understanding of our ongoing operating performance. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. To the extent this release contains historical or future non-GAAP financial measures, the Company has also provided corresponding GAAP financial measures for comparative purposes. Reconciliation between certain GAAP and non-GAAP measures is provided at the end of this press release.
Forward-Looking Statements
This press release contains forward-looking statements, each of which are qualified in their entirety by this cautionary statement. Any statements contained herein which do not describe historical facts, including, but not limited to the statements related to our financial and operational guidance, the anticipated timing of potential regulatory actions and research and clinical development plans and milestones for Iclusig and our product candidates, along with the statements made by our Chief Executive Officer and under the caption “Recent Progress and Key Objectives,” are forward-looking statements that are based on management’s expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These factors, risks and uncertainties include, but are not limited to, our ability to successfully commercialize and generate profits from sales of our products; our ability to meet anticipated clinical trial commencement, enrollment and completion dates and regulatory filing dates for our products and product candidates and to move new development candidates into the clinic; our ability to execute on our key corporate initiatives; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory and pricing and reimbursement approvals to market our products; competition from alternative therapies; our reliance on the performance of third-party manufacturers, specialty pharmacies, distributors and other collaborators for the supply, distribution, development and/or commercialization of our products and product candidates; the occurrence of adverse safety events with our products and product candidates; the costs associated with our research, development, manufacturing, commercialization and other activities; the conduct, timing and results of preclinical and clinical studies of our products and product candidates, including that preclinical data and early-stage clinical data may not be replicated in later-stage clinical studies; the adequacy of our capital resources and the availability of additional funding; the ability to satisfy our contractual obligations, including under our leases, convertible debt and royalty financing agreements; patent protection and third-party intellectual property claims; litigation and government investigations; our operations in foreign countries with or through third parties; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.
ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES | ||||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||||
(Unaudited) | ||||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||||
In thousands, except per share data | September 30, | September 30, | ||||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||||
Revenue: | ||||||||||||||||||
Product revenue, net | $ | 34,300 | $ | 27,543 | $ | 133,260 | $ | 79,262 | ||||||||||
License and other revenue | 11,716 | 1,527 | 16,479 | 3,038 | ||||||||||||||
Total revenue | 46,016 | 29,070 | $ | 149,739 | 82,300 | |||||||||||||
Operating expenses: | ||||||||||||||||||
Cost of product revenue | 1,131 | 483 | 2,725 | 1,666 | ||||||||||||||
Research and development | 43,626 | 48,219 | 130,569 | 126,401 | ||||||||||||||
Selling, general and administrative | 26,249 | 36,744 | 96,468 | 118,916 | ||||||||||||||
Transaction related cost | - | - | 1,482 | - | ||||||||||||||
Restructuring charge | - | - | 3,010 | - | ||||||||||||||
Total operating expenses | 71,006 | 85,446 | 234,254 | 246,983 | ||||||||||||||
Loss from operations | (24,990 | ) | (56,376 | ) | (84,515 | ) | (164,683 | ) | ||||||||||
Other income (expense), net | (5,171 | ) | (4,917 | ) | 112,421 | (11,930 | ) | |||||||||||
(Loss) income before benefit from income taxes | (30,161 | ) | (61,293 | ) | 27,906 | (176,613 | ) | |||||||||||
Benefit from income taxes | (2,334 | ) | (5,842 | ) | (328 | ) | (5,328 | ) | ||||||||||
Net (loss) income | $ | (27,827 | ) | $ | (55,451 | ) | $ | 28,234 | $ | (171,285 | ) | |||||||
Net (loss) income per common share: | ||||||||||||||||||
-- basic | $ | (0.14 | ) | $ | (0.29 | ) | $ | 0.15 | $ | (0.91 | ) | |||||||
-- diluted | $ | (0.14 | ) | $ | (0.29 | ) | $ | 0.14 | $ | (0.91 | ) | |||||||
Weighted-average number of shares of common stock outstanding: | ||||||||||||||||||
-- basic | 193,225 | 188,921 | 191,677 | 188,456 | ||||||||||||||
-- diluted | 193,225 | 188,921 | 195,079 | 188,456 |
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION | |||||||||||||||
(Unaudited) | |||||||||||||||
September 30, | December 31, | ||||||||||||||
In thousands | 2016 | 2015 | |||||||||||||
Cash, cash equivalents and marketable securities | $ | 314,665 | $ | 242,295 | |||||||||||
Total assets | $ | 676,591 | $ | 546,692 | |||||||||||
Total liabilities | $ | 722,940 | $ | 649,833 | |||||||||||
Stockholders’ deficit | $ | (46,349 | ) | $ | (103,141 | ) | |||||||||
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION | |||||||||||
(Unaudited) | |||||||||||
Nine Months Ended | |||||||||||
In thousands | September 30, | ||||||||||
2016 | 2015 | ||||||||||
Net cash used in operating activities | $ | (121,436 | ) | $ | (120,658 | ) | |||||
Net cash provided by (used in) investing activities | 103,577 | (4,446 | ) | ||||||||
Net cash provided by financing activities | 92,053 | 54,778 | |||||||||
Effect of exchange rates on cash | (44 | ) | (175 | ) | |||||||
Net increase (decrease) in cash and cash equivalents | $ | 74,150 | $ | (70,501 | ) | ||||||
Reconciliation of Selected GAAP Measures to Non-GAAP Measures (1) | |||||||||||||||||
(Unaudited) | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
In thousands, except per share data | September 30, | September 30, | |||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||
Reconciliation of GAAP to non-GAAP Net (loss) income: | |||||||||||||||||
GAAP Net (loss) income | $ | (27,827 | ) | $ | (55,451 | ) | $ | 28,234 | $ | (171,285 | ) | ||||||
Add: Stock-based Compensation (2) | 5,282 | 9,931 | 14,659 | 29,009 | |||||||||||||
Add: Restructuring Charges (3) | - | - | 3,010 | - | |||||||||||||
Add: Transaction related cost (4) | - | - | 1,482 | - | |||||||||||||
Non-GAAP Net (loss) income | $ | (22,545 | ) | $ | (45,520 | ) | $ | 47,385 | $ | (142,276 | ) | ||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||
Reconciliation of GAAP to non-GAAP Net (loss) income per diluted share: | |||||||||||||||||
GAAP Net (loss) income | $ | (0.14 | ) | $ | (0.29 | ) | $ | 0.14 | $ | (0.91 | ) | ||||||
Add: Stock-based Compensation (2) | 0.02 | 0.05 | 0.08 | 0.16 | |||||||||||||
Add: Restructuring Charges (3) | - | - | 0.01 | - | |||||||||||||
Add: Transaction related cost (4) | - | - | 0.01 | - | |||||||||||||
Non-GAAP Net (loss) income per diluted share | $ | (0.12 | ) | $ | (0.24 | ) | $ | 0.24 | $ | (0.75 | ) |
(1) This presentation includes non-GAAP measures. The Company's non-GAAP measures are not meant to be | |
considered in isolation or as a substitute for comparable GAAP measures and should be read only in conjunction | |
with its financial statements prepared in accordance with GAAP. | |
(2) All stock-based compensation expenses were excluded for the non-GAAP analysis. | |
(3) Restructuring charges associated with employee workforce reductions were excluded for the non-GAAP | |
analysis. | |
(4) Transaction related cost associated with the Incyte transaction were excluded for the non-GAAP analysis. |
CONTACT:
ARIAD Pharmaceuticals, Inc.
For Investors
Jennifer
Robinson, 617-621-2286
Jennifer.Robinson@ariad.com
or
For
Media
Liza Heapes, 617-621-2315
Liza.Heapes@ariad.com