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 24, 2014

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):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Section 2 — Financial Information

Item 2.02Results of Operations and Financial Condition.

On July 24, 2014, TESARO, Inc. issued a press release announcing its operating results for the quarter ended June 30, 2014.  A copy of the press release is attached to this current report as Exhibit 99.1 and is incorporated herein by reference.  TESARO, Inc. has scheduled a conference call and webcast for 4:15 p.m. Eastern time on July 24, 2014 to discuss its operating results for the quarter ended June 30, 2014, and slides for that call are attached to this report as Exhibit 99.2 and are incorporated herein by reference.

The information contained in this report, including Exhibit 99.1 and Exhibit 99.2, is 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 9.01Financial Statements and Exhibits.

(d)Exhibits.

Exhibit No.	Description
99.1	TESARO, Inc. press release dated July 24, 2014 announcing operating results for the quarter ended June 30, 2014.
99.2	TESARO, Inc. slides for July 24, 2014 conference call and webcast for the quarter ended June 30, 2014.

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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/ Timothy R. Pearson
		Timothy R. Pearson
		Executive Vice President and Chief Financial Officer
Dated: July 24, 2014

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EXHIBIT INDEX

Exhibit No.	Description
99.1	TESARO, Inc. press release dated July 24, 2014 announcing operating results for the quarter ended June 30, 2014.
99.2	TESARO, Inc. slides for July 24, 2014 conference call and webcast for the quarter ended June 30, 2014.

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EX-99.1

Exhibit 99.1

FOR RELEASE ON JULY 24, 2014 at 4:01 PM ET

TESARO ANNOUNCES SECOND-QUARTER 2014 OPERATING RESULTS

·Oral Rolapitant New Drug Application (NDA) on Track for Submission to U.S. FDA

·Enrollment in Niraparib NOVA Trial Non-gBRCA Cohort Expected to Be Complete at Year End

·Enrollment in Phase 1 Trial of Niraparib in Patients with Ewing’s Sarcoma Initiated

·Anti-TIM-3 Clinical Lead and Back Up Antibodies Identified

·Cash and Cash Equivalents Totaled Approximately $151 Million as of June 30, 2014

WALTHAM, MA, July 24, 2014 — TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today reported financial results for the second quarter of 2014.

“We are very pleased with the feedback we received from the oncology community regarding the rolapitant pivotal data set presented at the recent ASCO and MASCC conferences,” said Lonnie Moulder, CEO of TESARO. “The rolapitant NDA remains on track for submission to the U.S. FDA in approximately six weeks, and pre-launch commercial activities are well underway. We are also pleased with the pace of enrollment in our Phase 3 niraparib NOVA trial for patients with ovarian cancer, and we expect the non-germline BRCA cohort to be fully enrolled at the end of this year.”

Recent Business Highlights

·Final results from three Phase 3 clinical trials of oral rolapitant were presented in June at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago and at the MASCC/ISOO International Symposium on Supportive Care in Cancer annual meeting in Miami. Each of the three Phase 3 trials successfully achieved the primary endpoint of complete response, defined as no emesis and no use of rescue medication, during the delayed phase following administration of chemotherapy.

·A multiple ascending dose (MAD) study of intravenous (IV) rolapitant has been completed and confirmed the safety and tolerability profile of repeated daily doses.

·Patient enrollment continues in the Phase 3 NOVA and BRAVO trials of niraparib, and planning is underway to support initiation of additional niraparib clinical trials in the small cell lung cancer and first line ovarian cancer maintenance settings.

·Patient enrollment has begun in the Phase 1 study of niraparib plus temozolomide in patients with Ewing’s sarcoma;

·The clinical activity of a fractionated dose of TSR-011 continues to be evaluated in ALK-positive and TRK-positive patients.

·Preclinical studies of TSR-042 (anti-PD-1 antibody candidate) continue in collaboration with AnaptysBio, and lead and back up clinical antibody candidates targeting TIM-3 have been identified.

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Second-Quarter 2014 Financial Results

·TESARO reported a net loss of $37.1 million, or $1.03 per share, for the second quarter of 2014, compared to a net loss of $21.6 million, or $0.67 per share, for the second quarter of 2013.

·Research and development expenses increased to $30.6 million for the second quarter of 2014, compared to $18.2 million for the second quarter of 2013, driven primarily by higher costs related to expanded development activities and increased headcount. The Company also recorded $0.9 million of in-process research and development expense as a result of making a milestone payment related to niraparib clinical development during the second quarter of 2014.

·General and administrative expenses increased to $5.6 million for the second quarter of 2014, compared to $3.4 million for the second quarter of 2013, primarily related to increased headcount, higher non-cash stock-based compensation expense and higher professional service fees.

·Operating expenses as described above include total non-cash stock-based compensation expense of $3.1 million for the second quarter of 2014, compared to $1.6 million for the second quarter of 2013.

·As of June 30, 2014, TESARO had approximately $151.1 million in cash and cash equivalents, no debt and approximately 36.0 million outstanding shares of common stock.

2014 Corporate Objectives

TESARO anticipates achieving the following key objectives during the second half of 2014:

·Submit the oral rolapitant New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in approximately six weeks;

·Initiate a clinical trial of IV rolapitant to support the planned future NDA submission for registration following regulatory approval of oral rolapitant;

·Continue to advance the Phase 3 NOVA trial of niraparib as a maintenance therapy for patients with ovarian cancer and the Phase 3 BRAVO trial of niraparib in breast cancer patients with germline BRCA mutations;

·Advance the TSR-011 controlled release formulation work and further evaluate the clinical activity of a fractionated dose of TSR-011 in ALK-positive and TRK-positive patients;

·Advance the development of TSR-042 (anti-PD-1 antibody) to support submission of an Investigational New Drug (IND) Application to the U.S. FDA in late 2015; and

·Initiate IND enabling studies for the anti-TIM-3 clinical candidate and select an anti-LAG-3 antibody for clinical development during the third quarter of 2014.

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Today’s Conference Call and Webcast

TESARO will host a conference call to discuss the Company’s second quarter operating results today at 4:15 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 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

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 programs for our product candidates and statements under the heading 2014 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 expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the initiation and conduct of clinical trials, availability of data from ongoing clinical trials, the challenges in selecting product candidates, expectations with respect to regulatory submissions and approvals, challenges associated with expanding operations to include commercial activities, 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 Annual Report on Form 10-K for the year ended December 31, 2013 and other filings TESARO makes with the Securities and Exchange Commission.

###

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TESARO, Inc.

Unaudited Condensed Consolidated Statements of Operations

(in thousands, except per share amounts)

		Three Months Ended						Six Months Ended
		June 30,						June 30,
		2013			2014			2013			2014
Expenses:
Research and development (1)		$	18,177		$	30,569		$	34,680		$	58,686
General and administrative (1)		3,412			5,587			5,812			10,275
Acquired in-process research and development		—			900			—			17,900
Total expenses		21,589			37,056			40,492			86,861
Loss from operations		(21,589		)	(37,056		)	(40,492		)	(86,861		)
Interest income		25			5			59			10
Net loss		$	(21,564	)	$	(37,051	)	$	(40,433	)	$	(86,851	)
Net loss per share applicable to common stockholders - basic and diluted		$	(0.67	)	$	(1.03	)	$	(1.32	)	$	(2.45	)
Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted		32,336			35,982			30,577			35,422
(1) Expenses include the following amounts of non-cash stock-based compensation expense:
	Research and development	$	462		$	1,454		$	794		$	2,364
	General and administrative	1,122			1,648			1,560			3,276

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TESARO, Inc.

Unaudited Condensed Consolidated Balance Sheets

(in thousands)

	December 31,		June 30,
	2013		2014
Assets
Current assets:
Cash and cash equivalents	$	130,310	$	151,088
Other current assets	4,029		2,997
Total current assets	134,339		154,085
Property and equipment, net	440		1,147
Other assets	799		908
Total assets	$	135,578	$	156,140
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	1,869	$	2,849
Accrued expenses	10,541		16,163
Other current liabilities	13		—
Total current liabilities	12,423		19,012
Other non-current liabilities	3		—
Commitments and contingencies
Total stockholders’ equity	123,152		137,128
Total liabilities and stockholders’ equity	$	135,578	$	156,140

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EX-99.2

Exhibit 99.2

Second-Quarter Results July 24, 2014

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. 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 Annual Report on Form 10-K for the year ended December 31, 2013 and our subsequent filings with the SEC. TESARO, Inc. undertakes no obligation to update or revise any forward-looking statement for any reason. Rolapitant, niraparib and TSR-011 are investigational product candidates that have not been approved by any regulatory agency. The most frequently observed adverse events in the oral rolapitant Phase 3 studies were balanced across treatment arms and included fatigue, alopecia and constipation. Phase 1 data indicate that the most frequently observed adverse events for niraparib at a 300 milligram dose included grade 1/2 anemia, fatigue and nausea. Phase 1 data indicate that TSR-011 was well tolerated at therapeutic dose levels, and the most frequently occurring dose limiting toxicities included ECG changes and dysaethesia, both of which were reversible.

Lonnie Moulder Chief Executive Officer

 CINV: Chemotherapy-induced nausea & vomiting A/C: anthracycline/cyclophosphamide. MEC: Moderately emetogenic chemotherapy; HEC: Highly emetogenic chemotherapy. NSCLC: Non-small cell lung cancer. * In collaboration with SARC, the Sarcoma Alliance for Research through Collaboration. A Balanced Portfolio of Product Candidates Compound Indication Discovery Pre-clinical Phase 1 Phase 2 Phase 3 Rolapitant Oral NK-1 receptor antagonist CINV in A/C-breast cancer/ MEC treated patients CINV in cisplatin (HEC) treated patients CINV in cisplatin (HEC) treated patients Rolapitant IV CINV Niraparib PARP Inhibitor Ovarian Cancer BRCA+ Breast Cancer Niraparib + temozolomide Ewing’s sarcoma* TSR-011 ALK and TRK Inhibitor NSCLC, others TSR-042 Anti-PD-1 antibody Various tumor types Anti-TIM-3 antibody Various tumor types Anti-LAG-3 antibody Various tumor types Anti-TIM-3/PD-1 antibody Various tumor types Anti-LAG-3/PD-1 antibody Various tumor types

Tim Pearson Chief Financial Officer

Q2 2014 Financial Results Three Months Ended June 30, 2014 Three Months Ended June 30, 2013 Expenses: Research & Development $30,569 $18,177 General & Administrative 5,587 3,412 Acquired In-process R&D 900 - Total Expenses 37,056 21,589 Loss from Operations (37,056) (21,589) Interest Income 5 25 Net Loss ($37,051) ($21,564) Loss per Share ($1.03) ($0.67) As of June 30, 2014: Cash & equivalents balance totaled approximately $151 million Approximately 36.0 million shares outstanding of common stock

Mary Lynne Hedley, Ph.D. President

NDA: New drug application IV: Intravenous SCLC: Small cell lung cancer IND: Investigational new drug application Development Programs Update Each of three pivotal trials successfully achieved its primary endpoint Data was presented at ASCO & MASCC meetings Pre-NDA meeting held; oral NDA on track for submission in approx. 6 weeks Multiple ascending dose (MAD) study of IV rolapitant completed Rolapitant Phase 3 NOVA trial non-gBRCA cohort enrollment expected to complete at year end Phase 3 BRAVO trial enrollment continues Phase 1 trial in Ewing’s sarcoma initiated Planning ongoing for SCLC and first line ovarian trials Niraparib Fractionated doses are being evaluated in the ongoing Phase 1 study Additional ALK+ and TRK+ patients enrolling Controlled release formulation identified TSR-011 Anti-TIM-3 clinical lead and several backup antibody candidates identified Advancing TSR-042 antibody (anti-PD-1) to support IND filing with U.S. FDA in late 2015 Goal to select an anti-LAG-3 antibody for clinical studies in Q3 2014 I-O Platform

NDA: New drug application IV: Intravenous SCLC: Small cell lung cancer IND: Investigational new drug application Development Programs Update Each of three pivotal trials successfully achieved its primary endpoint Data was presented at ASCO & MASCC meetings Pre-NDA meeting held; oral NDA on track for submission in approx. 6 weeks Multiple ascending dose (MAD) study of IV rolapitant completed Rolapitant Phase 3 NOVA trial non-gBRCA cohort enrollment expected to complete at year end Phase 3 BRAVO trial enrollment continues Phase 1 trial in Ewing’s sarcoma initiated Planning ongoing for SCLC and first line ovarian trials Niraparib Fractionated doses are being evaluated in the ongoing Phase 1 study Additional ALK+ and TRK+ patients enrolling Controlled release formulation identified TSR-011 Anti-TIM-3 clinical lead and several backup antibody candidates identified Advancing TSR-042 antibody (anti-PD-1) to support IND filing with U.S. FDA in late 2015 Goal to select an anti-LAG-3 antibody for clinical studies in Q3 2014 I-O Platform

NDA: New drug application IV: Intravenous SCLC: Small cell lung cancer IND: Investigational new drug application Development Programs Update Each of three pivotal trials successfully achieved its primary endpoint Data was presented at ASCO & MASCC meetings Pre-NDA meeting held; oral NDA on track for submission in approx. 6 weeks Multiple ascending dose (MAD) study of IV rolapitant completed Rolapitant Phase 3 NOVA trial non-gBRCA cohort enrollment expected to complete at year end Phase 3 BRAVO trial enrollment continues Phase 1 trial in Ewing’s sarcoma initiated Planning ongoing for SCLC and first line ovarian trials Niraparib Fractionated doses are being evaluated in the ongoing Phase 1 study Additional ALK+ and TRK+ patients enrolling Controlled release formulation identified TSR-011 Anti-TIM-3 clinical lead and several backup antibody candidates identified Advancing TSR-042 antibody (anti-PD-1) to support IND filing with U.S. FDA in late 2015 Goal to select an anti-LAG-3 antibody for clinical studies in Q3 2014 I-O Platform

NDA: New drug application IV: Intravenous SCLC: Small cell lung cancer IND: Investigational new drug application Development Programs Update Each of three pivotal trials successfully achieved its primary endpoint Data was presented at ASCO & MASCC meetings Pre-NDA meeting held; oral NDA on track for submission in approx. 6 weeks Multiple ascending dose (MAD) study of IV rolapitant completed Rolapitant Phase 3 NOVA trial non-gBRCA cohort enrollment expected to complete at year end Phase 3 BRAVO trial enrollment continues Phase 1 trial in Ewing’s sarcoma initiated Planning ongoing for SCLC and first line ovarian trials Niraparib Fractionated doses are being evaluated in the ongoing Phase 1 study Additional ALK+ and TRK+ patients enrolling Controlled release formulation identified TSR-011 Anti-TIM-3 clinical lead and several backup antibody candidates identified Advancing TSR-042 antibody (anti-PD-1) to support IND filing with U.S. FDA in late 2015 Goal to select an anti-LAG-3 antibody for clinical studies in Q3 2014 I-O Platform

Lonnie Moulder Chief Executive Officer

Commercial Organization: Hiring Targeted for Late in NDA Review Process Approximately 120 Total Headcount Opportunity for Significant Leverage: Anticipate Rolapitant P&L to Break Even at Annual Sales of ~$50-60M NDA: New Drug Application

CINV: chemotherapy-induced nausea & vomiting ALKi: ALK inhibitor IO: Immuno-oncology KOL: Key opinion leader Market opportunity projections are based upon Company estimates TESARO Is Positioned for Success Cash and equivalents of ~$151M as of 6/30/2014 Well Capitalized Commercial, development and regulatory experience in oncology Relationships with KOLs and national oncology networks Experienced Team Promising Pipeline Rolapitant: Differentiated profile; unmet market need that can be addressed via education and adherence to existing guidelines Niraparib: Two Phase 3 trials; Phase 1 data demonstrated high response rates among heavily pre-treated patients TSR-011: Compelling Phase 1 data in ALKi-resistant patients TSR-042: IND filing targeted for late 2015 Anti-TIM-3 and anti-LAG-3 programs advancing Significant Market Opportunities Rolapitant: $1.5B U.S. CINV market Niraparib: >$3B WW initial indications

[LOGO]

Submit NDA for oral rolapitant to the U.S. FDA Advance IV rolapitant clinical program Continue to advance niraparib Phase 3 NOVA and BRAVO trials Expand the niraparib clinical development program and continue enrolling the combination study in Ewing’s sarcoma Continue to evaluate activity of TSR-011 in ALK+ and TRK+ patients Advance development of TSR-042 (anti-PD-1 antibody) and anti-TIM-3 candidate Select anti-LAG-3 antibody candidate NDA: New drug application FDA: Food & Drug Administration IV: Intravenous 2H 2014 Key Priorities

Second-Quarter Results July 24, 2014