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 21, 2018
Blueprint Medicines Corporation
(Exact name of registrant as specified in its charter)
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Delaware |
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001-37359 |
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26-3632015 |
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(I.R.S. Employer |
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45 Sidney Street Cambridge, Massachusetts |
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02139 |
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(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (617) 374-7580
38 Sidney Street, Suite 200
Cambridge, Massachusetts 02139
(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On February 21, 2018, Blueprint Medicines Corporation (the “Company”) announced its financial results for the quarter and year ended December 31, 2017. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is intended to be furnished 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 it be deemed 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit relating to Item 2.02 of this Current Report on Form 8-K shall be deemed to be furnished and not filed:
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Exhibit No. |
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Description |
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99.1 |
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Press release issued by Blueprint Medicines Corporation on February 21, 2018 |
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EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1 |
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Press release issued by Blueprint Medicines Corporation on February 21, 2018 |
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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.
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BLUEPRINT MEDICINES CORPORATION |
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Date: February 21, 2018 |
By: |
/s/ Jeffrey W. Albers |
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Jeffrey W. Albers |
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Chief Executive Officer |
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Exhibit 99.1
Blueprint Medicines Reports Fourth Quarter and Full Year 2017 Financial Results
– Presented clinical data from ongoing Phase 1 trials of avapritinib in patients with advanced gastrointestinal stromal tumors and advanced systemic mastocytosis at CTOS and ASH Annual Meetings –
– BLU-782 selected as development candidate for the treatment of fibrodysplasia ossificans progressiva –
– Completed successful follow-on offering in December 2017 and ended year with $673.4 million in cash, cash equivalents and investments –
– Plans to present initial clinical data from Phase 1 trial of BLU-667 in patients with RET-altered solid tumors on track for first half of 2018 –
CAMBRIDGE, Mass., February 21, 2018 – Blueprint Medicines Corporation (NASDAQ:BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, today reported financial results and provided a business update for the fourth quarter and full year ended December 31, 2017.
“2017 marked a year of significant achievements for Blueprint Medicines as we moved closer to realizing our vision of delivering a new generation of kinase medicines to patients with genomically defined diseases,” said Jeff Albers, Chief Executive Officer of Blueprint Medicines. “We presented transformative data across our full clinical-stage portfolio and expanded our extensive pipeline of highly selective kinase medicines with the nomination of our fourth development candidate, BLU-782. In 2018, we expect to continue this cadence of clinical and preclinical data disclosures, while also working to progress avapritinib quickly toward potential approval for gastrointestinal stromal tumors and systemic mastocytosis and to define the development path for BLU-554. We also plan to devote additional resources to commercial readiness as we progress pivotal clinical trials in multiple patient populations.”
Clinical Programs:
Avapritinib: Gastrointestinal Stromal Tumors (GIST)
Avapritinib: Systemic Mastocytosis (SM)
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In December 2017, Blueprint Medicines presented updated data from the dose escalation portion of its ongoing Phase 1 clinical trial of avapritinib in patients with advanced SM, called the Explorer trial, at the 59th American Society of Hematology Annual Meeting and Exposition (ASH). The data showed an ORR of 72 percent and a disease control rate of 100 percent in patients evaluable for response, based on the |
International Working Group – Myeloproliferative Neoplasms Research and Treatment and European Competence Network on Mastocytosis consensus criteria. The data also showed that avapritinib was generally well-tolerated and most AEs reported by investigators were Grade 1 or 2. Read the full data here. |
Avapritinib: Recent Scientific Publications
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In November 2017, Blueprint Medicines announced the publication of preclinical data and clinical case studies for avapritinib, highlighting the potent activity of avapritinib against activation loop mutations, as well as a broad spectrum of additional clinically relevant mutations, with a selectivity profile minimizing inhibition of other kinases. The paper, titled “A precision therapy against cancers driven by KIT/PDGFRA mutations” was published online in Science Translational Medicine. |
BLU-554: Hepatocellular Carcinoma
BLU-667: RET-Altered Solid Tumors
Research Programs:
Corporate Highlights:
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In December 2017, Blueprint Medicines announced the closing of an underwritten public offering of 4,259,259 shares of its common stock at a public offering price of $81.00 per share, including the exercise in full by the underwriters of their option to purchase additional shares of common stock. Blueprint |
Medicines received net proceeds from the offering of approximately $325.7 million, after deducting underwriting discounts and commissions and offering expenses. |
Fourth Quarter and Year End 2017 Financial Results:
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Collaboration Revenues: Collaboration revenues were $1.6 million for the fourth quarter of 2017 and $21.4 million for the year ended December 31, 2017, as compared to $7.7 million for the fourth quarter of 2016 and $27.8 million for the year ended December 31, 2016. This decrease was primarily due to the termination of the Alexion agreement during the fourth quarter of 2017. |
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Net Loss: Net loss was $49.0 million for the fourth quarter of 2017 and $148.1 million for the year ended December 31, 2017, or a net loss per share of $1.23 and $3.92, respectively, as compared to a net loss of $21.3 million for the fourth quarter of 2016 and $72.5 million for the year ended December 31, 2016, or a net loss per share of $0.75 and $2.64, respectively. |
Financial Guidance:
Based on its current plans, Blueprint Medicines expects that its existing cash, cash equivalents and investments, excluding any potential option fees and milestone payments under its existing collaboration with Roche, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the middle of 2020.
Conference Call Information:
Blueprint Medicines will host a live conference call and webcast today at 8:30 a.m. ET. The conference call may be accessed by dialing 1-855-728-4793 (domestic) or 1-503-343-6666 (international) and referring to conference ID 3391675. A webcast of the conference call will be available in the Investors section of the Blueprint Medicines’ website at http://ir.blueprintmedicines.com. The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.
About Blueprint Medicines:
Blueprint Medicines is developing a new generation of targeted and potent kinase medicines to improve the lives of patients with genomically defined diseases. Its approach is rooted in a deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases. Blueprint Medicines is advancing four
programs in clinical development for subsets of patients with gastrointestinal stromal tumors, hepatocellular carcinoma, systemic mastocytosis, non-small cell lung cancer, medullary thyroid cancer and other advanced solid tumors, as well as multiple programs in research and preclinical development. For more information, please visit www.blueprintmedicines.com.
Availability of Other Information About Blueprint Medicines:
Investors and others should note that Blueprint Medicines communicates with its investors and the public using its company website (www.blueprintmedicines.com), including but not limited to investor presentations and scientific presentations, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. You can also connect with Blueprint Medicines on Twitter (@BlueprintMeds) or LinkedIn. The information that Blueprint Medicines posts on these channels and websites could be deemed to be material information. As a result, Blueprint Medicines encourages investors, the media and others interested in Blueprint Medicines to review the information that it posts on these channels, including Blueprint Medicines' investor relations website, on a regular basis. This list of channels may be updated from time to time on Blueprint Medicines' investor relations website and may include other social media channels than the ones described above. The contents of Blueprint Medicines' website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
Cautionary Note Regarding Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans and timelines for the clinical development of avapritinib, BLU-554, BLU-667 and BLU-782; the potential benefits of Blueprint Medicines’ current and future drug candidates in treating patients; plans and timelines for presenting preclinical and clinical data for Blueprint Medicines’ current or future clinical trials; plans and timelines for initiating Blueprint Medicines’ Voyager trial; plans and timelines for initiating a registration-enabling clinical trial in patients with advanced SM; plans and timelines for initiating a proof-of-concept Phase 2 clinical trial in patients with indolent and smoldering SM; plans and timelines for engaging regulatory authorities to obtain input on registration pathways for avapritinib and BLU-554; the timing of initial clinical data for Blueprint Medicines’ Phase 1 clinical trial for BLU-667; plans and timelines for initiating the expansion portion of Blueprint Medicines’ Phase 1 clinical trial for BLU-667; plans and timelines for initiating IND-enabling studies for BLU-782; the timing for reporting preclinical data for the BLU-782 program; plans to devote additional resources to commercial readiness; expectations regarding plans and timelines for pivotal clinical trials in multiple patient populations; expectations regarding potential milestones; expectations regarding Blueprint Medicines’ existing cash, cash equivalents and investments; and Blueprint Medicines’ strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the delay of any current or planned clinical trials or the development of Blueprint Medicines’ drug candidates, including avapritinib, BLU-554, BLU-667 and BLU-782; Blueprint Medicines’ advancement of multiple early-stage efforts; Blueprint Medicines’ ability to successfully demonstrate the safety and efficacy of its drug candidates; the preclinical and clinical results for Blueprint Medicines’ drug candidates, which may not support further development of such drug candidates; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; Blueprint Medicines’ ability to develop and commercialize companion diagnostic tests for its current and future drug candidates, including companion diagnostic tests for BLU-554 for FGFR4-driven HCC, avapritinib for PDGFRα D842V-driven GIST and BLU-667 for RET-driven NSCLC; and the success of Blueprint Medicines’ cancer immunotherapy collaboration with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Blueprint Medicines’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, as filed with the Securities and Exchange Commission (SEC)
on October 31, 2017, and any other filings that Blueprint Medicines has made or may make with the SEC in the future. Any forward-looking statements contained in this press release represent Blueprint Medicines’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Blueprint Medicines explicitly disclaims any obligation to update any forward-looking statements.
Blueprint Medicines Corporation
Selected Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
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December 31, |
December 31, |
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2017 |
2016 |
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Cash, cash equivalents and investments |
$ |
673,356 |
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268,218 | ||
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Unbilled accounts receivable |
— |
3,577 | ||||
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Working capital (1) |
642,615 | 191,913 | ||||
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Total assets |
715,737 | 282,795 | ||||
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Deferred revenue |
35,373 | 47,235 | ||||
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Term loan payable |
1,518 | 4,069 | ||||
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Lease incentive obligation |
16,331 | 3,370 | ||||
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Total stockholders’ equity |
623,970 | 213,078 | ||||
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(1) Blueprint Medicines defines working capital as current assets less current liabilities. |
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Blueprint Medicines Corporation
Condensed Consolidated Statements of Operations Data
(in thousands, except per share data)
(unaudited)
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Three Months Ended |
Years Ended |
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December 31, |
December 31, |
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2017 |
2016 |
2017 |
2016 |
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Collaboration revenue |
$ |
1,628 |
$ |
7,691 |
$ |
21,426 |
$ |
27,772 | ||||
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Operating expenses: |
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Research and development |
43,629 | 24,073 | 144,687 | 81,131 | ||||||||
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General and administrative |
8,092 | 4,991 | 27,986 | 19,218 | ||||||||
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Total operating expenses |
51,721 | 29,064 | 172,673 | 100,349 | ||||||||
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Other income (expense): |
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Other income, net |
1,108 | 201 | 3,349 | 551 | ||||||||
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Interest expense |
(42) | (91) | (221) | (469) | ||||||||
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Total other income |
1,066 | 110 | 3,128 | 82 | ||||||||
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Net loss |
$ |
(49,027) |
$ |
(21,263) |
$ |
(148,119) |
$ |
(72,495) | ||||
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Net loss per share applicable to common stockholders — basic and diluted |
$ |
(1.23) |
$ |
(0.75) |
$ |
(3.92) |
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(2.64) | ||||
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Weighted-average number of common shares used in net loss per share applicable to common stockholders — basic and diluted |
39,988 | 28,450 | 37,793 | 27,492 | ||||||||
Media and Investor Relations Contacts:
Kristin Hodous
617 714 6674
khodous@blueprintmedicines.com
Jim Baker
617 844 8236
jbaker@blueprintmedicines.com