8-K

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): July 25, 2013

TESARO, Inc.

(Exact name of registrant as specified in its charter)

Delaware (state or other jurisdiction of
incorporation) 001-35587 (Commission
File Number) 27-2249687 (I.R.S. Employer
Identification No.)

1000 Winter Street Suite 3300 Waltham, Massachusetts	02451
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code:  (339) 970-0900

(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):

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))

Section 2 — Financial Information

Item 2.02              Results of Operations and Financial Condition.

On July 25, 2013, TESARO, Inc. (the “Company”) issued a press release announcing its operating results for the quarter ending June 30, 2013. A copy of the press release is attached to this current report as Exhibit 99.1 and is incorporated herein by reference.

Section 5 — Corporate Governance and Management

Item 5.02              Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers

(b), (e)              Resignation of Principal Financial Officer, Consulting Agreement

On July 25, 2013, Richard J. Rodgers, the Company’s Executive Vice President, Chief Financial Officer, Treasurer and Secretary informed the Company that he would resign all positions with the Company and its subsidiaries effective August 31, 2013.   Mr. Rodgers and the Company have agreed that he and the Company will enter into a consulting agreement effective August 31, 2013, pursuant to which he will serve as a consultant to the Company through March 31, 2014.  Mr. Rodgers and the Company have agreed that the terms of the consulting agreement will provide that he will be available to provide consulting services as requested from time to time up to sixty hours per month, that he will receive monthly compensation of $5,000 per month, and that he will receive hourly compensation of $250 per hour for services that exceed 20 hours per month.

(c)Appointment of Principal Financial Officer

On July 25, 2013, the Board of Directors of TESARO appointed Edward C. English, age 46, as the Vice President of Finance and Administration and Principal Financial Officer of the Company effective August 31, 2013.  Mr. English currently serves as the Company’s Vice President and Controller, a position he has held since December 12, 2012, when he was appointed as the Principal Accounting Officer of the Company.  Mr. English originally joined the Company in June 2012, as Controller. Prior to joining the Company, Mr. English served from 2011 to 2012 as Controller of Mascoma Corporation, a privately held bio-fuel company, and prior to that served from 2007 to 2011 in a variety of positions of increasing responsibility at AMAG Pharmaceuticals, Inc., including as Corporate Controller, Vice President and Corporate Controller and finally Interim Chief Financial Officer. Before AMAG Pharmaceuticals, Mr. English spent 10 years at PRAECIS PHARMACEUTICALS, Inc., where he held a variety of roles, including, immediately prior to its acquisition by GlaxoSmithKline PLC, the role of Vice President, Chief Financial Officer, Treasurer and Assistant Secretary. Mr. English started his career as a Certified Public Accountant with KPMG LLP in Boston, Massachusetts, where he held various positions, including audit manager within the Health Care and Life Sciences assurance practice. Mr. English holds an undergraduate degree from Georgetown University and a joint M.S. in accounting and M.B.A. from the Northeastern University Graduate School of Professional Accounting.

Section 9 — Financial Statements and Exhibits

Item 9.01              Financial Statements and Exhibits.

(d)           Exhibits.

Exhibit No.	Description
99.1	TESARO, Inc. press release dated July 25, 2013 announcing operating results for the quarter ended June 30, 2013

2

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.

	TESARO, Inc.
	By:	/s/ Richard J. Rodgers
		Richard J. Rodgers
		Executive Vice President, Chief Financial Officer,
		Secretary and Treasurer
Dated: July 25, 2013

3

EX-99.1

Exhibit 99.1

FOR RELEASE ON JULY 25, 2013 at 4:01 PM ET

TESARO ANNOUNCES SECOND-QUARTER 2013 OPERATING RESULTS

·Top-Line Results from Rolapitant Phase 3 Program to be Announced by Year-End 2013

·Patient Enrollment Ongoing in Phase 3 Trial of Niraparib in Ovarian Cancer

·Phase 3 Trial of Niraparib in Breast Cancer On Track to Begin 2H 2013

·First TSR-011 Clinical Data Accepted for Presentation at ESMO

·Cash and Cash Equivalents Totaled $178 Million as of June 30, 2013

WALTHAM, MA, July 25, 2013 – TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today reported financial results for the second quarter of 2013.

“TESARO is well positioned to meet several significant milestones in the second half of this year. We plan to report top-line results from the rolapitant pivotal program by year end, and we remain on track to begin enrollment in a Phase 3 study of niraparib in patients with BRCA-positive breast cancer,” said Lonnie Moulder, chief executive officer of TESARO. “In addition, we look forward to continued enrollment in our Phase 3 trial of niraparib for ovarian cancer and to the first presentation of TSR-011 clinical data in September.”

Business Highlights

·Enrollment continues in each of three Phase 3 trials of rolapitant for the prevention of chemotherapy induced nausea and vomiting (CINV). TESARO anticipates that top-line data from this pivotal program will be announced by year end.

·Results from a pharmacokinetic study of rolapitant were presented at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) International Symposium in Berlin. These data support concomitant administration of rolapitant with other pharmaceutical products that are metabolized by the liver microsomal enzyme CYP3A4, without a requirement for dose adjustment of the co-administered product.

·TESARO’s Phase 3 pivotal study of niraparib in patients with high grade serous, platinum-sensitive ovarian cancer, including those with germline BRCA mutations, has begun patient enrollment.

·Clinical site selection is ongoing to support the initiation of a Phase 3 pivotal study of niraparib in breast cancer patients with germline BRCA mutations during the second half of 2013.

·Final Phase 1 results for niraparib were presented at the American Society of Clinical Oncology (ASCO) annual meeting. Data demonstrated a favorable benefit/risk profile and durable responses among heavily pretreated patients with breast and ovarian cancer.

·An abstract describing initial clinical data for TSR-011 has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Congress in September.

1

Second-Quarter 2013 Financial Results

·TESARO reported a net loss of $21.6 million, or $0.67 per share, for the second quarter of 2013, compared to a net loss of $20.2 million, or $21.31 per share, for the second quarter of 2012. The Company’s second-quarter 2012 net loss included $7.0 million of acquired in-process R&D expense related to the in-license of niraparib.

·Research and development expenses increased to $18.2 million for the second quarter of 2013, compared to $11.5 million for the second quarter of 2012, driven primarily by expanded activities for our ongoing development programs.

·General and administrative expenses increased to $3.4 million for the second quarter of 2013, compared to $1.7 million for the comparable period in the previous year, primarily as a result of increases in non-cash stock-based compensation and other general and administrative personnel costs.

·Operating expenses as described above include non-cash stock-based compensation expense of $1.6 million for the second quarter of 2013, compared to $0.4 million for the second quarter of 2012.

·As of June 30, 2013, TESARO had $178.1 million in cash and cash equivalents, no debt and 32.6 million outstanding shares of common stock.

2013 Corporate Objectives

During the second half of 2013, TESARO anticipates achieving the following key objectives:

·Announce top-line results from the Phase 3 program evaluating oral rolapitant for the prevention of CINV by the end of 2013;

·Advance the clinical development of the rolapitant intravenous (IV) formulation in order to support a future submission for registration concurrent with regulatory approval of the oral formulation;

·Continue enrollment of the Phase 3 trial of niraparib as a potential maintenance therapy for patients with ovarian cancer;

·Initiate a Phase 3 trial of niraparib in breast cancer patients with germline BRCA mutations; and

·Finalize the recommended Phase 2 dose for TSR-011 and initiate Phase 2a expansion cohorts.

Today’s Conference Call and Webcast

TESARO will host a conference call to discuss the Company’s second-quarter 2013 accomplishments and financial results today at 4:30 p.m. Eastern time. The accompanying slide presentation and live webcast of the conference call can be accessed by visiting the TESARO website at www.tesarobio.com. The call can be accessed by dialing (877) 853-5334 (U.S. and

2

Canada) or (970) 315-0307 (international). A replay of the webcast will be archived on the Company’s website for 30 days following the call.

About TESARO

TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com.

Investor/Media Contact:

Jennifer Davis

Sr. Director, Corporate Development & Investor Relations

+1.781.325.1116 or jdavis@tesarobio.com

3

TESARO, Inc. Unaudited Condensed Consolidated Statements of Operations (in thousands, except per share amounts)
	Three Months Ended June 30,						Six Months Ended June 30,
	2012			2013			2012			2013
Expenses:
Research and development	$	11,532		$	18,177		$	19,682		$	34,680
General and administrative	1,685			3,412			2,884			5,812
Acquired in-process research and development	7,000			—			7,000			—
Total expenses	20,217			21,589			29,566			40,492
Loss from operations	(20,217		)	(21,589		)	(29,566		)	(40,492		)
Interest income	39			25			59			59
Net loss	$	(20,178	)	$	(21,564	)	$	(29,507	)	$	(40,433	)
Net loss per share applicable to common stockholders - basic and diluted	$	(21.31	)	$	(0.67	)	$	(36.11	)	$	(1.32	)
Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted	947			32,336			817			30,577

4

TESARO, Inc.

Unaudited Condensed Consolidated Balance Sheets

(in thousands)

	December 31,		June 30,
	2012		2013
Assets
Current assets:
Cash and cash equivalents	$	125,445	$	178,091
Other current assets	1,175		1,564
Total current assets	126,620		179,655
Property and equipment, net	219		504
Other assets	541		863
Total assets	$	127,380	$	181,022
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	3,170	$	1,964
Accrued expenses	8,545		9,977
Other current liabilities	3		13
Total current liabilities	11,718		11,954
Other non-current liabilities	—		9
Commitments and contingencies
Total stockholders' equity	115,662		169,059
Total liabilities and stockholders’ equity	$	127,380	$	181,022

To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward looking statements contained in this press release include, among others, statements regarding our expectations regarding our development plans for our product candidates and statements under the heading 2013 Corporate Objectives. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those

5

expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the initiation of future clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, and other matters that could affect the availability or commercial potential of our drug candidates. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO’s Form 10-K for the year ended December 31, 2012, and Form 10-Q for the quarter ended June 30, 2013.

6