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): February 14, 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 February 14, 2013, TESARO, Inc. issued a press release announcing its operating results for the quarter and year ending December 31, 2012. A copy of the press release is attached to this current report as Exhibit 99.1 and is incorporated herein by reference.

Section 7 — Regulation FD Disclosure

Item 7.01              Regulation FD Disclosure.

Attached as Exhibit 99.2 are slides being presented by TESARO, Inc. to discuss the development status of niraparib.

The information contained in this current report, including Exhibits 99.1 and 99.2, are being furnished to the Securities and Exchange Commission and 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 liabilities under that section. Furthermore, such information shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

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 February 14, 2013 announcing operating results for the quarter and year ending December 31, 2012
99.2	TESARO, Inc. slides on development status of niraparib, dated February 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:  February 14, 2013

3

EXHIBIT INDEX

Exhibit No.	Description
99.1	TESARO, Inc. press release dated February 14, 2013 announcing operating results for the quarter and year ending December 31, 2012
99.2	TESARO, Inc. slides on development status of niraparib, dated February 2013

4

EX-99.1

Exhibit 99.1

TESARO Announces Fourth Quarter and Year-end 2012 Operating Results

·Niraparib to be Advanced in a Phase 3 Pivotal Trial for Ovarian Cancer

·Enrollment Continues in the Global Registration Program for Rolapitant

·Achieved Third Dose-level in a Phase 1/2 Clinical Trial of TSR-011

Waltham, Massachusetts — February 14, 2013 — TESARO, Inc. (Nasdaq: TSRO) an oncology-focused biopharmaceutical company today reported financial results for the fourth quarter and full year 2012 and provided an update on the Company’s progress.

“We are very pleased to be advancing niraparib into a registration program in the maintenance setting for platinum sensitive ovarian cancer and intend to initiate this Phase 3 clinical trial by mid-year,” said Lonnie Moulder, Chief Executive Officer. “In addition, we are on track to report topline results from the rolapitant global registration program in the second half of the year, and have achieved the third dose-level in a Phase 1/2 clinical trial for TSR-011. We look forward to an exciting and productive 2013 for TESARO.”

Recent Accomplishments

TESARO continues to advance the development of its pipeline of oncology supportive care and anticancer product candidates.

·The Company has met with the FDA and finalized its clinical development program for niraparib, an orally active and potent PARP (poly (ADP-ribose) polymerase) inhibitor, in the ovarian cancer setting. TESARO will initiate a pivotal Phase 3 randomized double-blind, international trial to evaluate the potential benefit of niraparib compared to a placebo on the maintenance of response following completion of a platinum containing chemotherapy regimen. The study will separately evaluate the benefit of niraparib in two groups of ovarian cancer patients, those with and without certain deficiencies in DNA repair. The rationale for this study includes robust Phase 1 and 2 data showing a high response rate in patients with ovarian cancer who are treated with PARP inhibitors, compelling Phase 1 data from the dose escalation and expansion clinical study of niraparib, as well as the results of a study with a comparable design in the ovarian cancer maintenance setting that showed a strong progression free survival, or PFS, benefit for patients receiving another investigational PARP inhibitor. The Company expects to initiate this Phase 3 clinical trial by mid-year.

1

·The Company initiated the rolapitant global registration program in early 2012 and is continuing to enroll cancer patients in each of three phase 3 clinical trials. This global registration program evaluating rolapitant for the prevention of chemotherapy induced nausea and vomiting (CINV) is currently being conducted at more than 200 clinical trial sites located in 25 countries. TESARO intends to announce topline results for the three Phase 3 pivotal trials in the second half of 2013.

·Following clearance in late September of the Investigational New Drug (IND) application for TSR-011, an orally available anaplastic lymphoma kinase (ALK) inhibitor (targeted anti-cancer agent) by the FDA, the first cancer patient was enrolled in a Phase 1/2 clinical study. The third dosing cohort in the dose escalation phase of the study was initiated in January of 2013. Once the maximum tolerated dose of TSR-011 is identified, the Company plans to evaluate TSR-011 in three parallel cohorts of patients: those with ALK positive non-small cell lung cancer (NSCLC) who have not been previously treated with an ALK inhibitor, those with ALK positive NSCLC who have progressed during treatment with an ALK inhibitor and those patients with other tumor types that express ALK.

Fourth Quarter and Year-end 2012 Financial Results

·TESARO reported a net loss of $18.7 million for the fourth quarter of 2012 and $61.8 million for the year ended December 31, 2012. This compares to a net loss of $9.1 million and $16.4 million for the fourth quarter and year ended December 31, 2011, respectively. Net loss attributable to common stockholders for the fourth quarter of 2012 was $0.70 per share, compared to $15.41 per share for the fourth quarter of 2011. Net loss attributable to common stockholders for the year ended December 31, 2012 was $4.51 per share, compared to $31.90 per share for the year ended December 31, 2011.

·Research and development expenses totaled $15.6 million for the fourth quarter of 2012 and $47.2 million for the full year 2012, compared to $8.0 million for the fourth quarter of 2011 and $11.8 million for the full year 2011. Research and development expenses increased from 2011 primarily due to the expanded development activities for rolapitant and TSR-011 as well as the in-licensing of niraparib in mid-2012.

·The Company recorded $8.0 million of acquired in-process research and development expense in 2012, $7.0 million of which related to the in-licensing of niraparib and $1.0 million related to a fourth quarter development milestone payment with respect to TSR-011.

·General and administrative expenses totaled $2.1 million for the fourth quarter of 2012 and $6.7 million for the full year 2012, compared to $1.1 million and $3.2 million for the comparable periods in the previous year. The increase in general and administrative expenses was primarily due to increased personnel and professional fees.

2

·Operating expenses as described above include stock-based compensation expense of $1.8 million for the full year 2012, compared to $0.3 million for the full year 2011.

·As of December 31, 2012, TESARO had $125.4 million in cash and cash equivalents, no debt and 27.1 million outstanding shares of common stock.

2013 Key Objectives

During 2013, TESARO anticipates achieving the following key objectives:

·Announce topline results for the three Phase 3 pivotal trials evaluating oral rolapitant for the prevention of CINV.

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

·Begin enrollment of the Phase 3 pivotal trial of niraparib as a potential maintenance therapy for ovarian cancer patients.

·Advance the TSR-011 development program and define a strategy for the next phase of clinical development.

Today’s Conference Call and Webcast Reminder

TESARO will host a conference call to discuss the Company’s fourth quarter and year-end 2012 accomplishments and financial results today at 8:00 a.m. (ET). The call can be accessed by dialing 1.877.853.5334 (US and Canada) or 1.970.315.0307 (international). A live webcast of the conference call can also be accessed by visiting the TESARO website at www.tesarobio.com. 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.  TESARO is headquartered in Waltham, Massachusetts.  For more information, visit www.tesarobio.com.

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

3

product candidates and statements under the heading 2013 Key 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 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 Prospectus filed with the Securities and Exchange Commission on June 29, 2012, and future filings with the SEC, including TESARO’s Form 10-K for the year ended December 31, 2012.

TESARO, Inc.

Unaudited Condensed Consolidated Statements of Operations

(in thousands, except per share amounts)

	Three Months Ended December 31,						Years Ended December 31,
	2011			2012			2011			2012
Expenses:
Research and development	$	8,001		$	15,642		$	11,768		$	47,200
General and administrative	1,090			2,095			3,158			6,715
Acquired in-process research and development	—			1,000			500			8,000
Total expenses	9,091			18,737			15,426			61,915
Loss from operations	(9,091		)	(18,737		)	(15,426		)	(61,915		)
Interest income	13			40			38			152
Other income(expense)	—			—			(1,010		)	—
Net loss	$	(9,078	)	$	(18,697	)	$	(16,398	)	$	(61,763	)
Net loss per share applicable to common stockholders - basic and diluted	$	(15.41	)	$	(0.70	)	$	(31.90	)	$	(4.51	)
Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted	589			26,740			514			13,696

4

TESARO, Inc.

Unaudited Condensed Consolidated Balance Sheets

(in thousands)

	December 31, 2011			December 31, 2012
Assets
Current assets:
Cash and cash equivalents	$	39,825		$	125,445
Other current assets	2,606			1,175
Total current assets	42,431			126,620
Property and equipment, net	118			219
Restricted cash	200			—
Other assets	130			541
Total assets	$	42,879		$	127,380
Liabilities, convertible preferred stock and stockholders’ (deficit) equity
Current liabilities:
Accounts payable	$	605		$	3,170
Accrued expenses	2,980			8,545
Other current liabilities	11			3
Total current liabilities	3,596			11,718
Other non-current liabilities	3			—
Commitments and contingencies
Convertible preferred stock	64,348			—
Total stockholders’ (deficit) equity	(25,068		)	115,662
Total liabilities, convertible preferred stock and stockholders’ (deficit) equity	$	42,879		$	127,380

This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in TESARO’s prospectus filed with the Securities and Exchange Commission on June 29, 2012, which includes the audited financial statements for the year ended December 31, 2011, and the financial statements for the year ended December 31, 2012, which will be filed with TESARO’s Form 10-K for the year ended December 31, 2012.

For Further Information Contact:

Richard Rodgers

Executive Vice President & CFO

+1.339.970.0903

rrodgers@tesarobio.com

5

EX-99.2

Exhibit 99.2

Niraparib (PARP Inhibitor) Phase 3 Pivotal Program for Ovarian Cancer February 14, 2013

Safe Harbor Statement Statements made in this presentation about TESARO, Inc. that are not descriptions of historical facts are forward-looking statements reflecting the current beliefs and expectations of management. Forward-looking statements are sometimes identified by words such as “plan,” “may,” “will,” “expect,” and similar expressions referencing future events, conditions or circumstances. Forward-looking statements in this presentation include, without limitation, statements on the slides “Phase 3 Design and Objectives,” “Niraparib Phase 3 Design Specifics” and “Niraparib Summary.” These forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Actual results could differ materially from those expressed or implied by these forward-looking statements as a result of various factors, including, without limitation, the various risks described in our Prospectus, filed with the Securities and Exchange Commission on June 29, 2012, and our future filings with the SEC, including our Form 10-K for the year ended December 31, 2012. TESARO, Inc. undertakes no obligation to update or revise any forward-looking statement for any reason.

Phase 1 Design and Objectives Overview Trial Design Objectives First in human, open-label, Phase 1 study Oral once daily dosing; two part study Initial results (n=80) reported ASCO 2011 Dose escalation and expansion study (n=104) evaluated 30mg – 400mg of niraparib (MK-4827) Primary Objectives: Evaluate safety and tolerability of niraparib Establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) Secondary Objectives: Evaluate pharmacokinetic and pharmacodynamic profiles of niraparib Assessment of anti-tumor activity

Niraparib Phase 1 Study Results Initial reported activity (n=80); mean prior regimens of 4.5 Overall clinical activity PR 12/80 (15%); 10 ovarian, 2 breast SD 24/80 (30%); ovarian, breast, lung, other SD > 12 weeks 18/80 (22.5%) Clinical activity in ovarian patients (n=39 evaluable) PR 10/39 (26%); SD 13/39 (33%) gBRCAmut patients: PR 7/19 (37%); SD 5/19 (26%); DCR1 63% Platinum sensitive patients had similar response rates, regardless of BRCA status Adverse events: Grade 1-2 patient reported events included fatigue, anorexia, nausea Final results (n=104) submitted for presentation at an upcoming medical meeting 1Disease control rate

Considerations for a Registration Study A well tolerated dose and schedule that provided for clinical activity were identified in the Phase 1a/b study Current formulation is acceptable for long term use (3 capsules, dosed once daily) Clinical Enrichment: Patients with relapsed platinum sensitive HGSOC (high grade serous ovarian cancer) experienced clinical benefit from niraparib treatment, regardless of gBRCAmut status Target Enrichment: Scientific rationale and clinical POC for targeting patients who carry gBRCAmut Published clinical trial data demonstrates prolongation of PFS following a platinum based chemotherapy regimen in patients with relapsed platinum sensitive HGSOC who are treated with a PARP inhibitor Standard of Care: placebo Dose/Schedule Enriched Target Population Formulation Feasible Study Design and Comparator

Considerations for Patient Enrichment High Grade Serous Ovarian Cancer (HGSOC): 50% of HGSOC patients are deficient in HR DNA repair1 Approximately one-half of these are patients are gBRCAmut Platinum Sensitivity in Ovarian Cancer: HR-deficient cells are more likely to be platinum sensitive because they are unable to repair DNA-damage induced by platinum adducts2 Regardless of gBRCA status, patients with platinum sensitive HGSOC experienced prolonged PFS when treated with a PARPi 93% of tested primary ovarian tumor cells functionally deficient in Homologous Recombination (HR) DNA repair respond to PARP inhibition3 Functional assays for use in global clinical trials have not been developed gBRCAmut is the best characterized individual genomic mutation that correlates with functional HR defects 1Clin Can Res 2010 p2344, Nature 2011, p609 2Nature 434:917-921, 2005 2Clin Can Res 2010 p2344, Nature 2011, p609 3Clin Can Res 2012, 72:5675 Clinical Enrichment Target Specific Enrichment

PARP inh. Ovarian Maintenance POC Ledermann J., et. al., N Engl J Med 2012 Median PFS: PARPi (8.4 months) vs. Control (4.8 months) Overall HR = 0.35; gBRCAmut HR = 0.10

Phase 3 Design and Objectives Overview Trial Design Objectives HGSOC, platinum sensitive, relapsed, in response to most recent platinum regimen Two independent cohorts: gBRCAmut (n=180) AND non-gBRCAmut (n=180) Double blind, placebo controlled, international study Each cohort is independently randomized 2:1 niraparib to placebo Continuous daily dosing with 300mg niraparib or placebo until progression Primary Objectives: PFS Each cohort is independently assessed Secondary Objectives: Patient reported outcomes that extend beyond progression Chemotherapy free interval OS

Niraparib Phase 3 Design Specifics High Grade Serous Ovarian Cancer, Platinum Sensitive, Relapsed placebo gBRCAmut 2:1 randomization Endpoint assessment Niraparib placebo 2:1 randomization Endpoint assessment Response to platinum treatment Non-gBRCAmut Niraparib

Continuous dosing with 300mg oral niraparib is well tolerated and resulted in clinical activity in a large Phase 1 dose escalation/cohort expansion study Patients with platinum sensitive HGSOC experience clinical benefit from treatment with PARP inhibitors, including niraparib, regardless of gBRCAmut status Patients with platinum sensitive HGSOC experienced prolonged PFS from treatment with a PARP inhibitor in a maintenance setting (HR 0.35), regardless of gBRCAmut status TESARO plans to initiate a Phase 3 trial of niraparib in patients with platinum sensitive HGSOC (gBRCAmut AND non-gBRCAmut) in the maintenance setting by mid-year Niraparib Summary