UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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): November 4, 2015
Momenta Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware |
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000-50797 |
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04-3561634 |
(State or Other Jurisdiction of Incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
675 West Kendall Street, Cambridge, MA |
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02142 |
(Address of Principal Executive Offices) |
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(Zip Code) |
(617) 491-9700
(Registrants telephone number,
including area code)
Not applicable
(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):
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ 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 & Financial Condition.
On November 4, 2015, Momenta Pharmaceuticals, Inc., a Delaware corporation, announced its financial results for the quarter ended September 30, 2015. 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.
The information in this Form 8-K (including Exhibit 99.1) 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 a filing.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:
99.1. Press Release issued by Momenta Pharmaceuticals, Inc. on November 4, 2015.
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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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MOMENTA PHARMACEUTICALS, INC. |
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Date: November 4, 2015 |
By: |
/s/ Richard P. Shea |
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Richard P. Shea Chief Financial Officer (Principal Financial Officer) |
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EXHIBIT INDEX
Exhibit No. |
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Description |
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99.1 |
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Press Release issued by Momenta Pharmaceuticals, Inc. on November 4, 2015. |
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Exhibit 99.1
MOMENTA PHARMACEUTICALS, INC. |
675 WEST KENDALL STREET |
T: 617.491.9700 F: 617.621.0430 |
CAMBRIDGE, MA 02142 |
WWW.MOMENTAPHARMA.COM |
Momenta Pharmaceuticals Reports Third Quarter 2015 Financial Results
CAMBRIDGE, MA November 4, 2015 Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) today reported its financial results for the third quarter ended September 30, 2015.
For the third quarter of 2015, the Company reported total revenues of $13.8 million, including $8.7 million of GlatopaTM (glatiramer acetate injection) profit share. For the nine months ended September 30, 2015, the Company reported total revenues of $67.3 million, including $27.9 million in product revenues from Sandozs sales of Glatopa. Momenta reported a net loss of $(30.1) million, or $(0.44) per share for the third quarter compared to a net loss of $(29.1) million, or $(0.56) per share for the same period in 2014. For the nine months ended September 30, 2015, the Company reported a net loss of $(54.1) million, or $(0.88) per share compared to a net loss of $(82.6) million, or $(1.61) per share for the same period in 2014. At September 30, 2015, the Company had cash, cash equivalents, and marketable securities of $374.9 million.
The launch of Glatopa is going according to plan with Glatopa scripts currently representing approximately 25% to 30% of the once daily glatiramer acetate market, said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. As the first marketed generic version of a multiple sclerosis drug, Glatopa is bringing value to both patients and payors.
We continue to advance our biosimilar and novel drug programs. Our Phase 2 study of necuparanib in pancreatic cancer is advancing and M923, our biosimilar HUMIRA® candidate, has entered a pivotal clinical trial, continued Mr. Wheeler. Our ongoing development activities should also allow us to move M834, our biosimilar ORENCIA® candidate, and our two novel recombinant autoimmune candidates into the clinic in 2016.
Third Quarter Highlights and Recent Events
Complex Generics:
GlatopaTM, generic version of daily COPAXONE® 20 mg (glatiramer acetate injection)
· Sandoz launched Glatopa on June 18, 2015. In the third quarter of 2015, Momenta recorded $8.7 million in product revenues from Sandozs Glatopa sales. Glatopa is experiencing positive trade uptake, although the impact on third quarter sales was limited as launch inventory continues to be worked through. In the second quarter of 2015 Momentas share of profit on sales of Glatopa was $28.2 million, and after a
deduction of $9.0 million in reimbursement to Sandoz of the Companys share of pre-launch Glatopa-related legal expenses, the Company recorded $19.2 million in product revenue.
· The ANDA for a three-times-a-week generic COPAXONE 40 mg (glatiramer acetate injection), submitted by Sandoz, is under FDA review.
Enoxaparin Sodium Injection
· The Company continues to pursue the patent infringement case related to Momentas U.S. Pat. 7,575,886 against Amphastar and Actavis. In July 2015, the U.S. Solicitor General, at the request of the Court of Appeals for the Federal Circuit, filed a brief in the case that supported Momentas interpretation of the scope of the safe harbor provisions under the Hatch Waxman Act. A CAFC decision is expected in 2015.
Biosimilars:
· In October 2015, Momenta and Baxalta announced the initiation of a pivotal clinical trial for M923, a biosimilar version of HUMIRA® (adalimumab). The trial is a randomized, double blind, active control, multi-center, global study in patients with chronic plaque psoriasis to compare the safety, efficacy and immunogenicity of M923 with HUMIRA. The companies are targeting first regulatory submission in 2017 and a first commercial launch in 2018.
· Momenta continues to develop M834, a biosimilar version of ORENCIA® (abatacept), and its portfolio of other biosimilar candidates and is in active discussions with potential partners to collaborate on the development and commercialization of a portfolio of its biosimilar candidates.
Novel Drug:
Necuparanib (novel oncology candidate)
· Momentas Phase 2 trial to evaluate the antitumor activity of necuparanib in combination with Abraxane® (nab-paclitaxel) plus gemcitabine, versus Abraxane plus gemcitabine alone, is enrolling. The Company expects to have clinical data available in the first half of 2017.
· The Company continues to collect data from the Phase 1 study and plans to publish and/or present updated results following completion of the study.
Autoimmune Drugs
Momentas three novel autoimmune candidates are in preclinical development. These candidates include a hyper-sialylated IVIg (hsIVIg), a high potency alternative to IVIg, and two recombinant molecules: M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. The Company is advancing the recombinant candidates with a goal of entering the clinic in late 2016, and is continuing its efforts to identify and explore potential partnering opportunities for the further development and commercialization of its hsIVIg program.
Third Quarter 2015 Financial Results
Total revenues for the third quarter of 2015 were $13.8 million compared to $9.3 million for the same period in 2014. Total revenues for the third quarter of 2015 includes $8.7 million in product revenue, which represents 50% of contractual profit earned from Sandozs sale of Glatopa.
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Enoxaparin product revenue decreased from $4.7 million for the third quarter of 2014 to zero for the same period in 2015. The decrease in enoxaparin product revenue was primarily due to the amendment of the enoxaparin sodium injection collaboration agreement in June 2015 which replaced Sandoz obligation to pay the Company a royalty on net sales with an obligation to pay 50% of profit on sales. In the third quarter of 2015, Sandoz did not earn a profit on its sales of enoxaparin due to continued competitive pricing.
Collaborative research and development revenue for the third quarter of 2015 was $5.1 million, compared to the $4.6 million recorded in the same quarter last year. The increase is primarily due to an increase in the quarterly amortization of the upfront payment under the Baxalta collaboration.
Research and development expenses for the third quarter of 2015 were $31.7 million, compared to $27.5 million for the same period in 2014. The increase of $4.2 million, or 15%, from the 2014 period primarily resulted from increases of $2.0 million in nonclinical and manufacturing expenditures to advance the novel autoimmune programs, $1.8 million in clinical trial expenses as the necuparanib Phase 2 clinical trial continued to enroll patients and $0.3 million in share-based compensation expense associated with performance-based stock awards.
General and administrative expenses for the quarter ended September 30, 2015, were $12.5 million, compared with $11.1 million for the same period in 2014. The increase of $1.4 million, or 13%, from the 2014 period primarily resulted from increases of $0.8 million in share-based compensation associated with performance-based stock awards and $0.3 million in professional fees.
At September 30, 2015, Momenta had $374.9 million in cash, cash equivalents and marketable securities. This cash position excludes restricted cash of $20.7 million, of which $17.5 million is reserved as collateral for a security bond related to enoxaparin legal proceedings, and $3.2 million for letters of credit related to the companys two leased facilities.
Financial Guidance
Today, Momenta provided guidance that it expects its operating expenses, excluding stock-based compensation and net of collaborative revenues, to be approximately $40 - $42 million per quarter for the fourth quarter of 2015.
Conference Call Information
Management will host a conference call and webcast today at 10:00 am ET to discuss these results and provide an update on the company. A live webcast of the conference call may be accessed on the Investors section of the companys website, www.momentapharma.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call and will be available for 90 days.
To access the call you may also dial (877) 224-9084 (domestic) or (720) 545-0022 (international) prior to the scheduled conference call time and provide the access code 60061735. A replay of the call will be available approximately two hours after the
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conclusion of the call and will be accessible through November 11, 2015. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 60061735.
About Momenta
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for oncology and autoimmune indications.
To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release.
Our logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.
Forward Looking Statements
Statements in this press release regarding managements future expectations, beliefs, intentions, goals, strategies, plans or prospects, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements about the Companys ability to meet its development goals for 2015; future operating expenses; program development and partnering plans; timing of regulatory submissions and product launches; timing of clinical trials and the availability and announcement of clinical data; and the timing of decisions related to patent litigation and other patent-related proceedings. Forward-looking statements may be identified by words such as anticipate, believe, continue, could, hope, target, project, goal, objective, guidance, plan, potential, predict, might, estimate, expect, intend, may, seek, should, will, would, look forward and other similar words or expressions, or the negative of these words or similar words or expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, including those referred to under the section Risk Factors in the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Companys actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. The Company is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
INVESTOR CONTACT: |
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MEDIA CONTACT: |
Sarah Carmody |
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Karen Sharma |
Momenta Pharmaceuticals |
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MacDougall Biomedical Communications |
1-617-395-5189 |
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1-781-235-3060 |
IR@momentapharma.com |
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Momenta@macbiocom.com |
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MOMENTA PHARMACEUTICALS, INC.
Unaudited Condensed Consolidated Balance Sheets
(in thousands)
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September 30, 2015 |
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December 31, 2014 |
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Assets |
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Cash and marketable securities |
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$ |
374,869 |
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$ |
191,529 |
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Accounts receivable |
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11,060 |
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7,427 |
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Restricted cash |
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20,660 |
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20,719 |
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Other assets |
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31,617 |
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36,541 |
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Total assets |
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$ |
438,206 |
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$ |
256,216 |
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Liabilities and Stockholders Equity |
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|
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Current liabilities |
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$ |
30,159 |
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$ |
23,789 |
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Deferred revenue, net of current portion |
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14,656 |
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25,508 |
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Other long-term liabilities |
|
129 |
|
551 |
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Stockholders equity |
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393,262 |
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206,368 |
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Total liabilities and stockholders equity |
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$ |
438,206 |
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$ |
256,216 |
|
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MOMENTA PHARMACEUTICALS, INC.
Unaudited Condensed Statements of Comprehensive Loss
(in thousands, except per share amounts)
|
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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|
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2015 |
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2014 |
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2015 |
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2014 |
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Collaboration revenues: |
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|
|
|
|
|
|
|
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Product revenue |
|
$ |
8,666 |
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$ |
4,714 |
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$ |
30,693 |
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$ |
15,216 |
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Research and development revenue |
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5,129 |
|
4,622 |
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36,565 |
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15,855 |
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Total collaboration revenue |
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13,795 |
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9,336 |
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67,258 |
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31,071 |
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|
|
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|
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|
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Operating expenses: |
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|
|
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|
|
|
|
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Research and development* |
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31,733 |
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27,508 |
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88,466 |
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80,289 |
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General and administrative* |
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12,459 |
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11,103 |
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33,678 |
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34,039 |
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Total operating expenses |
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44,192 |
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38,611 |
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122,144 |
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114,328 |
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|
|
|
|
|
|
|
|
|
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Operating loss |
|
(30,397 |
) |
(29,275 |
) |
(54,886 |
) |
(83,257 |
) |
|
|
|
|
|
|
|
|
|
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Other income: |
|
|
|
|
|
|
|
|
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Interest income |
|
252 |
|
112 |
|
486 |
|
452 |
|
Other income |
|
95 |
|
62 |
|
251 |
|
186 |
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Total other income |
|
347 |
|
174 |
|
737 |
|
638 |
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|
|
|
|
|
|
|
|
|
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Net loss |
|
$ |
(30,050 |
) |
$ |
(29,101 |
) |
$ |
(54,149 |
) |
$ |
(82,619 |
) |
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|
|
|
|
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|
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Basic and diluted net loss per share |
|
$ |
(0.44 |
) |
$ |
(0.56 |
) |
$ |
(0.88 |
) |
$ |
(1.61 |
) |
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|
|
|
|
|
|
|
|
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Weighted average shares used in computing basic and diluted net loss per share |
|
68,004 |
|
51,545 |
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61,442 |
|
51,456 |
|
|
|
|
|
|
|
|
|
|
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Comprehensive loss: |
|
|
|
|
|
|
|
|
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Net loss |
|
$ |
(30,050 |
) |
$ |
(29,101 |
) |
$ |
(54,149 |
) |
$ |
(82,619 |
) |
Net unrealized holding gains (losses) on available-for-sale marketable securities |
|
(4 |
) |
(26 |
) |
32 |
|
(5 |
) |
Comprehensive loss |
|
$ |
(30,054 |
) |
$ |
(29,127 |
) |
$ |
(54,117 |
) |
$ |
(82,624 |
) |
* Non-cash share-based compensation expense included in operating expenses is as follows:
Research and development |
|
$ |
2,122 |
|
$ |
1,509 |
|
$ |
3,031 |
|
$ |
4,755 |
|
General and administrative |
|
$ |
2,435 |
|
$ |
1,890 |
|
$ |
3,756 |
|
$ |
5,760 |
|
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