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): February 23, 2015
Momenta Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware |
|
000-50797 |
|
04-3561634 |
(State or Other Jurisdiction |
|
(Commission File Number) |
|
(IRS Employer Identification No.) |
675 West Kendall Street, Cambridge, MA |
|
02142 |
(Address of Principal Executive Offices) |
|
(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):
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))
Item 8.01. Other Events
Momenta Pharmaceuticals, Inc., which is referred to herein as the Company or Momenta, recently updated its business information as follows:
On February 17, 2015, the Company reported its financial results for the fourth quarter and year ended December 31, 2014.
For the fourth quarter of 2014, the Company reported a net loss of $(16.0) million, or $(0.31) per share, compared to a net loss of $(30.1) million, or $(0.59) per share for the same period in 2013. For the year ended December 31, 2014, the Company reported a net loss of $(98.6) million, or $(1.91) per share, compared to a net loss of ($108.4) million, or $(2.13) per share, for the same period in 2013. At December 31, 2014, the Company had cash, cash equivalents, and marketable securities of $191.5 million compared to $245.7 million at December 31, 2013.
Fourth Quarter Highlights and Recent Events
Complex Generics:
M356, generic version of Copaxone® (Glatiramer Acetate Injection)
· The ANDA for M356 continues to be under active review by the U.S. FDA. The Company and its collaboration partner, Sandoz, are prepared for the potential launch of this generic in 2015, pending U.S. FDA approval.
· On January 20, 2015, the United States Supreme Court vacated and remanded the 2013 decision of the Court of Appeals for the Federal Circuit which found several of the Copaxone (20 mg/mL injection) patents, including the one remaining patent which expires on September 1, 2015, invalid for being indefinite. The appeals court is expected to rehear the case and issue a new decision within a year.
· In August 2014, Momenta announced that the U.S. FDA accepted for review the ANDA for a 40 mg/mL three-times-weekly generic Copaxone, submitted by Sandoz Inc., Momentas development and commercialization collaborator for this product candidate.
Enoxaparin Sodium Injection
· In the fourth quarter of 2014, Momenta earned $4.7 million in product revenues from enoxaparin sodium injection based on Sandoz reported net sales of $47 million.
· The Company continues to pursue the patent infringement case related to Momentas U.S. Pat. 7,575,886 against Amphastar and Teva. In a 2012 decision, the Court of Appeals for the Federal Circuit (CAFC) held that Amphastars use of Momentas patented method is protected by the Hatch Waxman safe harbor (Momenta Pharmaceuticals vs. Amphastar Pharmaceuticals, Inc. Fed. Cir. Aug. 3, 2012). The safe harbor issue is on appeal at the CAFC again after a summary judgment decision subsequent to the 2012 CAFC decision. A hearing is expected during the first half of 2015 and a decision could be expected in 2015.
Biosimilar and Potentially Interchangeable Biologics:
· Due to Baxter Internationals company restructuring and change to a strong focus on later stage biosimilar assets, on February 16, 2015, Baxter terminated its license to M834 under the
collaboration agreement. Baxter also let expire its right to select additional targets for biosimilar development under the collaboration. Momenta and Baxter are continuing to collaborate on M923.
· In December 2014, Momenta announced the acceptance of a Clinical Trial Application (CTA) to initiate a clinical trial for M923, a biosimilar version of HUMIRA® (adalimumab), in Europe, in collaboration with Baxter. Acceptance of the CTA triggered two milestone payments under the Baxter collaboration with an aggregate payment of $12 million. A pharmacokinetic clinical trial has been initiated in Europe.
· Momentas second biosimilar candidate, M834, a biosimilar version of ORENCIA® (abatacept) and indicated for certain autoimmune and inflammatory diseases, achieved a pre-defined development milestone triggering a $7 million milestone payment from Baxter in the fourth quarter of 2014.
· Momenta will continue to develop M834 and will seek a new collaboration partner to assist in development and commercialization.
· Momenta continues to develop its portfolio of early stage biosimilar candidates and is in active discussions with potential collaboration partner(s) to assist in development and commercialization of its additional candidates.
Novel Drugs:
Necuparanib (novel oncology candidate)
· In October 2014, Momenta announced promising top-line results from the Part A of the Phase 1/2 study evaluating necuparanib in combination with Abraxane® (paclitaxel) and gemcitabine in patients with metastatic pancreatic cancer. The Company plans to present more mature data in mid-2015.
· Momenta also initiated the Phase 2 component of the necuparanib trial, which is a randomized, controlled study to evaluate the antitumor activity of necuparanib in combination with Abraxane plus gemcitabine, versus Abraxane plus gemcitabine alone. The Company expects to have clinical data available as early as the end of 2016.
· In December 2014, the U.S. FDA granted Fast Track designation to the investigation of necuparanib as a first-line treatment in combination with Abraxane® and gemcitabine in patients with metastatic pancreatic cancer.
Novel Autoimmune Drugs
In October 2014, Momenta introduced three novel autoimmune candidates that are currently in various stages of preclinical development. These candidates include a hyper-sialylated IVIg (hsIVIg), a high potency alternative to IVIg, and two recombinant molecules: a Selective Immunomodulator of Fc receptors (SIF3) and an anti-FcRn monoclonal antibody. The recombinant molecules have been designed by leveraging the Companys knowledge of the anti-inflammatory effects of IVIg to maximize therapeutic benefit and patient convenience. Momenta believes these programs could have potential in a range of diseases that currently have few treatment options such as autoimmune neuropathies, autoimmune blood disorders and blistering skin diseases. The Company expects to continue to advance the recombinant candidates with a goal of entering the clinic in late 2016 and remains in active partnering discussions for its hsIVIg product.
Fourth Quarter and Year End 2014 Financial Results
Total revenues for the fourth quarter of 2014 were $21.2 million (including enoxaparin product revenue of $4.7 million), compared to $12.8 million (including enoxaparin product revenue of $4.9 million) for the same period in 2013. Sandoz reported fourth quarter 2014 enoxaparin net sales of $47 million versus $51 million for the fourth quarter 2013. The decrease in enoxaparin product revenue reflects lower prices. For the year ended December 31, 2014, total revenue was $52.3 million, compared to $35.5 million for 2013.
Collaborative research and development revenue for the fourth quarter of 2014 was $16.4 million, compared to $7.8 million in the same quarter last year. For the year ended December 31, 2014, collaborative research and development revenues were $32.3 million, compared to $18.8 million for the year ended 2013. The increases in both periods are primarily due to the $12.0 million in M923 milestones earned under the Baxter Agreement and recognized as revenue in the fourth quarter of 2014. The $7.0 million milestone payment from Baxter for M834 was received in the fourth quarter of 2014 and will be recognized as revenue over the products development period.
Research and development expenses for the fourth quarter of 2014 were $26.2 million, compared to $32.2 million for the same period in 2013. The decrease of $6.0 million in research and development expenses from the fourth quarter of 2013 to the fourth quarter of 2014 was primarily due to lower biosimilars process development and research costs. For the year ended December 31, 2014, research and development expenses were $106.5 million, compared to $104.0 million for the year ended 2013. The increase of $2.5 million in research and development expenses from 2013 to 2014 resulted from increases of: $4.8 million in personnel and facilities-related expenses; $2.5 million to advance the novel drug research program; $1.9 million in necuparanib clinical costs; and $1.0 million in laboratory supplies. These increases were offset by a decrease of $7.6 million primarily related to lower third-party process development, contract research costs and consulting fees incurred for our biosimilars program.
General and administrative expenses for the quarter ended December 31, 2014, were $11.1 million, compared with $10.8 million for the same period in 2013. For the year ended December 31, 2014, general and administrative expenses were $45.2 million, compared to $41.1 million for the year ended 2013. The increase of $4.1 million from 2013 to 2014 was primarily due to increases of: $2.5 million in personnel and facilities-related costs; $0.6 million in office and information technology costs; $0.4 million in fees; and $0.3 million in depreciation expense.
At December 31, 2014, Momenta had $191.5 million in cash, cash equivalents and marketable securities. This cash position includes $18.3 million in net proceeds from the sale of approximately 1.7 million shares of common stock through the Companys At the Market (ATM) agreement with Stifel, Nicolaus & Company in the fourth quarter of 2014. 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.
Forward Looking Statements
Statements in this Current Report regarding the Companys 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 revenues and operating expense, timing for the generic Copaxone ANDA approval, timing and outcome of the patent litigation relating to generic Copaxone and the Companys enoxaparin patents,
future biosimilar program development plans, timing of presenting additional necuparanib trial data and the timing of clinical trials for the Companys novel drug product candidates. 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, target, 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 September 30, 2014, 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 Current Report as of this date and assumes no obligations to update the information included in this Current Report or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
MOMENTA PHARMACEUTICALS, INC.
Unaudited Condensed Consolidated Balance Sheets
(in thousands)
|
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December 31, |
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December 31, |
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Assets |
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|
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Cash and marketable securities |
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$ |
191,529 |
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$ |
245,682 |
|
Accounts receivable |
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7,427 |
|
13,095 |
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Restricted cash |
|
20,719 |
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20,719 |
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Other assets |
|
36,541 |
|
37,319 |
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Total assets |
|
$ |
256,216 |
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$ |
316,815 |
|
Liabilities and Stockholders Equity |
|
|
|
|
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Current liabilities |
|
$ |
23,789 |
|
$ |
21,942 |
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Deferred revenue, net of current portion |
|
25,508 |
|
24,024 |
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Other long-term liabilities |
|
551 |
|
1,012 |
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Stockholders equity |
|
206,368 |
|
269,837 |
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Total liabilities and stockholders equity |
|
$ |
256,216 |
|
$ |
316,815 |
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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 |
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Year Ended |
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2014 |
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2013 |
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2014 |
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2013 |
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Collaboration revenues: |
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|
|
|
|
|
|
|
| ||||
Product revenue |
|
$ |
4,747 |
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$ |
4,903 |
|
$ |
19,963 |
|
$ |
16,701 |
|
Research and development revenues |
|
16,432 |
|
7,847 |
|
32,287 |
|
18,764 |
| ||||
Total collaboration revenue |
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21,179 |
|
12,750 |
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52,250 |
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35,465 |
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|
|
|
|
|
|
|
|
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Operating expenses: |
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|
|
|
|
|
|
|
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Research and development* |
|
26,193 |
|
32,238 |
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106,482 |
|
103,999 |
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General and administrative* |
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11,125 |
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10,848 |
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45,164 |
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41,057 |
| ||||
Total operating expenses |
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37,318 |
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43,086 |
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151,646 |
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145,056 |
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|
|
|
|
|
|
|
|
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Operating loss |
|
(16,139 |
) |
(30,336 |
) |
(99,396 |
) |
(109,591 |
) | ||||
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|
|
|
|
|
|
|
|
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Other income: |
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|
|
|
|
|
|
|
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Interest income |
|
96 |
|
214 |
|
548 |
|
950 |
| ||||
Other income |
|
62 |
|
60 |
|
248 |
|
233 |
| ||||
Total other income |
|
158 |
|
274 |
|
796 |
|
1,183 |
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|
|
|
|
|
|
|
|
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Net loss |
|
$ |
(15,981 |
) |
$ |
(30,062 |
) |
$ |
(98,600 |
) |
$ |
(108,408 |
) |
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|
|
|
|
|
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Net loss per share: |
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|
|
|
|
|
|
|
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Basic and diluted |
|
$ |
(0.31 |
) |
$ |
(0.59 |
) |
$ |
(1.91 |
) |
$ |
(2.13 |
) |
|
|
|
|
|
|
|
|
|
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Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
| ||||
Basic and diluted |
|
52,255 |
|
51,185 |
|
51,664 |
|
50,907 |
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|
|
|
|
|
|
|
|
|
| ||||
Comprehensive loss |
|
$ |
(16,017 |
) |
$ |
(30,157 |
) |
$ |
(98,641 |
) |
$ |
(108,494 |
) |
*Includes the following share-based compensation expense: |
|
|
|
|
|
|
| ||||||
Research and development |
|
$ |
1,449 |
|
$ |
1,551 |
|
$ |
6,204 |
|
$ |
5,520 |
|
General and administrative |
|
$ |
1,630 |
|
$ |
1,916 |
|
$ |
7,390 |
|
$ |
7,302 |
|
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: February 23, 2015 |
By: |
/s/ Richard P. Shea |
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Richard P. Shea |
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Chief Financial Officer |
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(Principal Financial and Accounting Officer) |