Momenta Pharmaceuticals Reports Fourth Quarter and Year End 2016 Financial Results
For the fourth quarter of 2016, the Company reported total revenues of
"In 2016, Momenta reported significant advances across our portfolio. In early
Fourth Quarter Highlights and Recent Events
Glatopa 20 mg: First
February 17, 2017, the Company announced that Sandoz's contracted fill/finish manufacturing partner for Glatopa, Pfizer, has received an FDAwarning letter. The FDAwarning letter does not restrict the production or shipment of the Glatopa 20 mg product that is currently marketed by Sandoz in the United States.
- In the fourth quarter of 2016, Momenta recorded
$15.8 millionin product revenues from Sandoz's Glatopa 20 mg sales. For the year ended December 31, 2016, the Company recorded $74.6 millionin product revenues from Sandoz's sales of Glatopa 20 mg reflecting $78.2 millionin profit share.
Glatopa 40 mg: Designed to be a generic version of three-times-a-week COPAXONE® 40 mg (glatiramer acetate injection) for patients with relapsing forms of multiple sclerosis developed in collaboration with Sandoz
- The Abbreviated New Drug Application (ANDA) submitted by Sandoz for a three-times-a-week generic COPAXONE 40 mg is under
U.S. Food and Drug Administration(FDA) review. An approval of the application may be dependent on the satisfactory resolution of the compliance observations stated in the FDAwarning letter issued to Pfizer, the contracted fill/finish manufacturer for Glatopa. The Company believes that an approval in the first quarter of 2017 is unlikely.
January 30, 2017, the United States District Court for the District of Delawarefound Teva Pharmaceutical's U.S.Patent Nos. 8,232,250; 8,399,413; 8,969,302; and 9,155,776 for COPAXONE 40 mg invalid as obvious over the prior art. Teva has appealed the decision to U.S. Court of Appeals for the Federal Circuit(CAFC). The Company expects a decision from the CAFCwill be issued within 12 to 18 months and plans to aggressively defend against Teva's appeal.
- Teva has asserted infringement claims under two additional patents (
U.S.Patent Nos. 9,155,775 ("the ‘775 patent)" and 9,402,874 ("the ‘874 patent"), which claims Momenta believes to be invalid, not infringed and unenforceable. On February 17, 2017, Teva filed a motion for preliminary injunctive relief under the ‘775 patent seeking to enjoin a launch of Glatopa 40 mg. The Company plans to vigorously defend its freedom to launch and oppose these actions. As part of this defense, the Company has filed an action in the United StatesCourt for the District of Delawareseeking a declaratory judgment of invalidity, non-infringement and unenforceability for the ‘775 patent.
M923: a fully-owned proposed biosimilar to HUMIRA® (adalimumab)
December 2016, Momenta signed an early termination of the collaboration agreement with Baxalta, a wholly-owned subsidiary of Shire plc, to develop and commercialize M923. In January, the Company received a one-time asset return payment of $51.2 millionfrom Shire intended to fund Momenta's estimated costs of performing the development activities that would have been performed by Shire through the original termination date of September 27, 2017.
November 2016, the Company announced positive Phase 3 top-line results of M923 in patients with moderate-to-severe chronic plaque psoriasis. Momenta is targeting mid-2017 for the first submission for marketing approval of M923. Subject to marketing approval and patent considerations, the Company expects first commercial launch of M923 to be as early as 2020 timeframe.
M834: a proposed biosimilar to ORENCIA® (abatacept) being developed in collaboration with Mylan
November 2016, Momenta and its collaboration partner Mylan announced the initiation of a Phase 1 clinical trial for M834. The companies plan to report top-line data from the Phase 1 trial in the second half of 2017.
November 2016, Momenta received a $25.0 milliondevelopment milestone payment from Mylan to be applied toward the funding of Mylan's 50% share of collaboration expenses.
December 22, 2016, the U.S.Patent and Trademark Office's Patent Trial and Appeal Board issued their decision upholding the validity of U.S.Patent No. 8,476,239, related to Bristol Myers Squibb's ORENCIA (abatacept) product following the Company's Inter Partes Review challenging this patent. The Company is considering its options for appeal to the U.S. Court of Appeals for the Federal Circuit.
M710: a biosimilar candidate being developed in collaboration with Mylan
December 2016, in connection with a joint decision to continue development of M710, Momenta received a $35.0 millionmilestone payment from Mylan to be applied toward the funding of Mylan's 50% share of collaboration expenses.
Novel Drugs for Autoimmune Indications:
Momenta's novel autoimmune portfolio includes two recombinant molecules: M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. Momenta is also developing a hyper-sialylated IVIg (M254) as a potential high potency version of IVIg that is currently in pre-clinical development.
M230 (SIF3): a Selective Immunomodulator of Fc receptors
January 5, 2017, the Company announced that it has entered into a worldwide license agreement and an exclusive research collaboration with CSL to develop and commercialize Fc multimer proteins, including Momenta's M230, which is expected to enter the clinic in 2017. In addition to advancing M230, the agreement initiates a research collaboration to develop additional Fc multimer proteins that may originate from Momenta's or CSL's research.
February 17, 2017the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act (HSR Act) in connection with license agreement and research collaboration with CSL expired. Under the agreement, CSL is obligated to pay Momenta a $50 millionupfront cash payment within 30 days of the effective date of February 17, 2017.
M281 (anti-FcRn): a fully human monoclonal antibody (mAb) targeting the neonatal Fc receptor (FcRn)
- The Company has successfully completed the Phase 1 single ascending dose study in healthy volunteers. In the SAD portion of the study, a single dose of 30 mg/kg achieved up to 80% reduction of circulating IgG antibodies. M281 was well-tolerated and to date no serious adverse events have been observed. The multiple ascending dose portion of the
study was initiated in
- The Company plans to report the full data from the single and multiple ascending dose portions of the study in the second half of 2017.
Fourth Quarter and Year End 2016 Financial Results
Total revenues for the fourth quarter of 2016 were
For the year ended
Research and development expenses for the fourth quarter of 2016 were
General and administrative expenses for the quarter ended
Other Income for the fourth quarter of 2016 was
Momenta provides non-GAAP operating expense guidance, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the section of this press release below entitled "Non-GAAP Financial Information and Other Disclosures" for further discussion of this subject.
Non-GAAP operating expense is total operating expenses (which excludes collaboration expenses reimbursable by Mylan), less stock-based compensation expense and
collaboration expenses incurred by the Company that are reimbursable by Sandoz. Today, Momenta provided non-GAAP operating expense guidance of approximately
Non-GAAP Financial Information and Other Disclosures
Momenta uses a non-GAAP financial measure, non-GAAP operating expense, to provide operating expense guidance. Momenta believes this non-GAAP financial measure is useful to investors because it provides greater transparency regarding Momenta's operating performance and excludes non-cash stock compensation expense and is net of collaborative reimbursement revenues from Sandoz. This non-GAAP financial measure should not be considered an alternative to GAAP total operating expense and should not be considered a measure of Momenta's liquidity. Non-GAAP financial measures should not be considered as substitutes for measures calculated in accordance with GAAP and should only be used to supplement an understanding of Momenta's operating results as reported under GAAP. Momenta has not provided a GAAP reconciliation for its forward-looking non-GAAP annual operating expense because Momenta cannot reliably predict without unreasonable efforts the timing or amount of the factors that substantially contribute to the projection of stock compensation expense, which is excluded from the forward-looking non-GAAP financial measure. The Company has provided the anticipated reconciling information that is available without unreasonable effort in the section of this press release above entitled "Financial Guidance."
Conference Call Information
Management will host a conference call and webcast today at
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 62528080. A replay of the call will be available approximately two hours after
the conclusion of the call and will be accessible through
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 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
Forward Looking Statements
Statements in this press release regarding management's 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 timing of the regulatory approval and launch of our product candidates, including Glatopa 40 mg; the Company's ability to meet its development and strategic goals; the dependence of an approval of the Glatopa 40 mg ANDA on resolution of the compliance observations in the
|MOMENTA PHARMACEUTICALS, INC.|
|Unaudited Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and marketable securities||$||353,151||$||350,044|
|Liabilities and Stockholders' Equity|
|Deferred revenue, net of current portion||31,360||12,213|
|Other long-term liabilities||3,793||69|
|Total liabilities and stockholders' equity||$||477,737||$||421,040|
|Unaudited Condensed Statements of Operations and Comprehensive Income (Loss)|
|(in thousands, except per share amounts)|
|Ended December 31,||Ended December 31,|
|Research and development revenue||18,378||4,583||34,971||41,147|
|Total collaboration revenue||34,195||22,393||109,619||89,650|
|Research and development*||26,382||37,568||119,880||126,033|
|General and administrative*||18,165||14,373||64,466||48,051|
|Total operating expenses||44,547||51,941||184,346||174,084|
|Net income (loss)||$||41,539||$||(29,164||)||$||(21,003||)||$||(83,313||)|
|Basic net income (loss) per share||$||0.60||$||(0.43||)||$||(0.31||)||$||(1.32||)|
|Diluted net income (loss) per share||$||0.60||$||(0.43||)||$||(0.31||)||$||(1.32||)|
|Weighted average shares used in computing basic net income (loss) per share||69,003||68,138||68,656||63,130|
|Weighted average shares used in computing diluted net income (loss) per share||69,362||68,138||68,656||63,130|
|Comprehensive income (loss)||$||41,375||$||(29,176||)||$||(20,921||)||$||(83,293||)|
|* Non-cash share-based compensation expense included in operating expenses is as follows:|
|Research and development||$||1,132||$||2,114||$||7,558||$||5,145|
|General and administrative||$||2,434||$||2,539||$||10,764||$||6,295|
Sarah Carmody Momenta Pharmaceuticals1-617-395-5189 IR@momentapharma.com MEDIA CONTACT: Karen Sharma MacDougall Biomedical Communications1-781-235-3060 Momenta@macbiocom.com
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