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): January 11, 2016
SEQUENOM, INC.
(Exact
name of registrant as specified in its charter)
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| Delaware |
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000-29101 |
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77-0365889 |
| (State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(I.R.S. Employer
Identification No.) |
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| 3595 John Hopkins Court, San Diego, CA |
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92121 |
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(Zip Code) |
Registrant’s telephone number, including area code: (858) 202-9000
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)) |
| Item 2.02 |
Results of Operations and Financial Condition. |
On January 11, 2016, Sequenom, Inc. (the
“Company”) issued a press release announcing selected preliminary financial and operational results for the quarter and year ended December 31, 2015. A copy of the press release is attached as Exhibit 99.1 to this
current report.
On January 13, 2016, Dirk van den Boom, the Company’s President and Chief Executive Officer, will present at the JP Morgan 34th Annual Healthcare Conference in San Francisco, CA, starting at 4:00 pm Pacific time to provide an overview of and update on the Company. The presentation is expected to last approximately 30
minutes and will be webcast live through the “Invest” section of the Company’s website at www.sequenom.com. A replay will be available for 90 days following the initial presentation webcast at
http://jpmorgan.metameetings.com/confbook/healthcare16/directlink?p=19842.
The information in this Item 2.02, and Exhibit 99.1 attached
hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this current
report shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange Commission, whether filed before or after the date hereof regardless of any general incorporation language in any
such filing, unless we expressly set forth in such filing that such information is to be considered “filed” or incorporated by reference therein.
| Item 7.01 |
Regulation FD Disclosure. |
The information contained in Item 2.02, Results of Operations and
Financial Condition, is incorporated herein by reference in its entirety. In addition, in connection with the Company’s participation at the J.P. Morgan 34th Annual Healthcare
Conference on January 13, 2016 as referenced above, the Company is reporting on the status of its oncology development program. The Company is currently developing an RUO assay with an initial focus on the detection and molecular profiling of
late stage non-hematologic malignancies, where tissue biopsies are not available or too risky to obtain. Milestones achieved include:
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Development of the most comprehensive circulating tumor DNA assay covering a breadth of cancer types by analyzing over 130 cancer-related genes that are associated with a Food and Drug Administration (FDA)-approved drug
treatment, included in professional society guidelines, linked to targeted therapies currently in clinical trials, or part of well-documented cancer pathways |
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Establishment of a network of key opinion leaders in the therapy selection and monitoring space |
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Development of data interpretation and delivery solutions |
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High sensitivity (<0.5% mutation frequency) and high specificity (>99.999%) |
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Commencement of investigator initiated studies |
The information contained in Item 2.02, Results of Operations and Financial
Condition, is incorporated herein by reference in its entirety.
Forward-Looking Statements
Statements contained in this Current Report on Form 8-K regarding matters that are not historical facts are “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks
are described more fully in the registrant’s filings with the Securities and Exchange Commission, including without limitation the registrant’s most recent Quarterly Report on Form 10-Q and other documents subsequently filed
with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this Current Report on Form 8-K speak only as of the date on which they were made. The registrant undertakes no obligation to
update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
| Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits
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| 99.1 |
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Press release dated January 11, 2016 |
SIGNATURE
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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SEQUENOM, INC. |
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| Dated: January 11, 2016 |
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By: |
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/s/ Jeffrey D. Linton |
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Name: |
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Jeffrey D. Linton |
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Title: |
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Senior Vice President, General Counsel & Secretary |
Exhibit 99.1
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| FOR IMMEDIATE RELEASE |
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| Sequenom Contact: |
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| Paul Goodson |
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Rachel Lipsitz |
| Investor Relations |
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Media Contact |
| Sequenom, Inc. |
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inVentiv Health PR Group |
| 858-202-9427 |
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858-449-9575 |
| pgoodson@sequenom.com |
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rachel.lipsitz@inventivhealth.com |
SEQUENOM, INC. ANNOUNCES PRELIMINARY 2015 RESULTS,
PROVIDES UPDATE ON MaterniT® GENOME
SAN DIEGO, Calif. – Jan. 11, 2016 – Sequenom, Inc. (NASDAQ: SQNM), a life sciences company committed to enabling healthier lives through the
development of innovative products and services, today announced preliminary results for 2015, commented on its business progress during the fourth quarter of 2015, and provided an update on the performance of its recently launched MaterniT® GENOME laboratory-developed test.
Sequenom provided the following preliminary 2015 results
(unaudited):
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Sequenom’s preliminary revenue for 2015 was approximately $128 million |
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Over 42,000 total commercial diagnostic test samples were accessioned during the fourth quarter of 2015, as compared to approximately 41,000 in the third quarter of 2015 |
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Of the total, 37,300 noninvasive prenatal test (NIPT) samples were accessioned in the fourth quarter of 2015, as compared to 35,500 in the third quarter of 2015 |
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Total cash, cash equivalents and marketable securities as of December 31, 2015 were approximately $76 million |
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Cash burn was approximately $25 million for 2015 and $5 million for the fourth quarter of 2015 |
“Sequenom
made considerable progress during the fourth quarter,” said Dr. Dirk van den Boom, President and CEO. “Our goal is to set a new standard for NIPT by offering the most comprehensive noninvasive prenatal test solutions for physicians
and their patients. We are pleased to report that total test accessions increased sequentially from the third quarter, reflecting our increased focus on commercial and operational execution. Throughout the fourth quarter, we also established
clinical collaborations with key opinion leaders at four major academic centers for the development of our oncology liquid biopsy assay.”
The company’s emphasis on women’s health includes expanding its presence in the obstetrician and
gynecologist channel to better serve average risk pregnancies, while continuing to maintain its leadership among maternal fetal medicine specialists. Sequenom continues to advance its in-network relationships with insurers and payor networks, and
leveraging the potential of Sequenom’s newly launched MaterniT® Genome product.
MaterniT® GENOME Progress
“Demand for our new
MaterniT® GENOME product, launched just at the end of August, has been stronger than we originally expected, both domestically and internationally,” remarked Dr. van den Boom.
“While we are encouraged by the positive reception of MaterniT® GENOME by physicians and patients, we are carefully positioning the test with clinicians to ensure that it is used
where it can provide the highest value.” Over 3,000 MaterniT® GENOME tests were accessioned in the fourth quarter of 2015, representing the product’s first full quarter of sales.
2015 Results
Sequenom will provide its complete
results for the fourth quarter and full year 2015 in a conference call scheduled for March 2, 2016. The Company also plans to provide guidance for 2016 at that time. The Company will issue a press release with details for that announcement and
conference call at a later time.
This press release contains certain unaudited financial results for the Company’s fiscal year and fourth quarter
ended December 31, 2015. These unaudited results may change as a result of further review by the Company’s management and its independent auditors. The completion of the audit of our financial results for 2015 could result in changes to
the unaudited financial results presented in this press release and may identify issues related to the effectiveness of the Company’s internal controls over financial reporting.
Non-GAAP Financial Measures
“GAAP” refers to
financial information presented in accordance with generally accepted accounting principles in the United States. This press release includes a non-GAAP financial measure with respect to the year ended December 31, 2015. Management uses
non-GAAP financial measures because it believes that a cash flow metric incorporating cash used by operations and certain other uses of cash are important to understand the cash requirements of the business. The Company reported cash burn as a
non-GAAP financial measure. This non-GAAP financial measure is not in accordance with or an alternative to GAAP.
Management uses cash burn to evaluate performance compared to forecasts. Cash burn is calculated as the sum of
net cash used by operating activities, purchases of property, equipment and leasehold improvements, payments on long-term obligations, and payment of convertible note transaction costs.
About Sequenom
Sequenom, Inc. (NASDAQ: SQNM) is committed
to enabling healthier lives through the development of innovative products and services. The Company serves patients and physicians by providing early patient management information. To learn how Sequenom is interpreting the genome to improve your
life, visit www.sequenom.com.
About Sequenom Laboratories
Sequenom Laboratories, a CAP-accredited and CLIA-certified molecular diagnostics laboratory, has developed a broad range of laboratory tests, with a focus
principally on prenatal care. Branded under the names HerediT®, HerediT® UNIVERSAL, MaterniT® GENOME, MaterniT21® PLUS, NextView®, SensiGene® and VisibiliT™, these molecular genetic laboratory-developed tests provide early patient management information for obstetricians, geneticists, and maternal fetal medicine specialists.
Sequenom Laboratories is changing the landscape in genetic diagnostics using proprietary cutting edge technologies. Visit www.laboratories.sequenom.com and follow @SequenomLabs.
SEQUENOM®, HerediT®, MaterniT® GENOME, MaterniT21® PLUS, NextView®, SensiGene®, VisibiliT™ and Sequenom Laboratories™ are trademarks of Sequenom, Inc. All other trademarks and service marks are the property of their respective owners.
Forward-Looking Statements
Statements contained in this
press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the development of innovative products
and services, expanding the Company’s presence in the obstetrician and gynecologist channel to better serve average risk pregnancies, continuing to maintain leadership among maternal fetal medicine specialists, continuing to advance the
Company’s in-network relationships with insurers and payor networks and leveraging the potential of Sequenom’s newly launched MaterniT® Genome product. Because such statements are
subject to risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Company’s filings with the Securities and Exchange Commission, including
without limitation the Company’s most recent Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak
only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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