Momenta Pharmaceuticals Reports First Quarter 2016 Financial Results
For the first quarter of 2016, the Company reported total revenues of
"Since the beginning of 2016, Momenta has made steady progress in each of our business areas," said
"For the remainder of 2016, we look forward to
continued progress across our pipeline of biosimilar and novel drug programs including the presentation of final Phase 1 results from our necuparanib trial and Phase 1 study of M923," continued
First Quarter Highlights and Recent Events
- In the first quarter of 2016, Momenta recorded
$14.8 millionin product revenues from Sandoz's Glatopa sales. Since the launch of Glatopa in June 2015, Momenta has recorded $58.2 millionin product revenues from Sandoz's sales of Glatopa reflecting $67.3 millionin profit share net of a deduction of $9.1 millionfor reimbursement to Sandoz of the Company's share of pre-launch Glatopa-related legal expenses.
- The ANDA
submitted by Sandoz for a three-times-a-week generic COPAXONE® 40 mg (glatiramer acetate injection) is under
FDAreview. The Company expects to receive tentative regulatory approval in 2016.
- A district court trial challenging Teva's four Orange Book-listed patents for COPAXONE 40 mg (glatiramer acetate injection) is scheduled for
September 26, 2016.
- Momenta's product revenues from Sandoz's net sales of enoxaparin sodium injection decreased from
$2.7 millionin the first quarter of 2015 to zero for the same period in 2016.
April 2016, Momenta and Baxalta completed enrollment in the pivotal clinical trial for M923, a biosimilar candidate of HUMIRA® (adalimumab). The companies are targeting first regulatory submission in 2017 and a first commercial launch as early as 2018. The Company plans to present data from the pharmacokinetics study of M923 in a poster session at the European Leagueagainst Rheumatism (EULAR) Annual Congress in Londonon June 10, 2016.
January 2016, Momenta announced a global collaboration with Mylan N.V. to develop, manufacture and commercialize six of the Company's biosimilar candidates, including M834, a biosimilar candidate of ORENCIA® (abatacept). On February 9, 2016, the companies received clearance for the collaboration under the Hart-Scott-Rodino Antitrust Improvements Act. In the first quarter of 2016 Momenta received an upfront cash payment of $45 millionfrom Mylan.
January 2016, the U.S. Patent and Trademark Office(PTAB) instituted Momenta's request for an Inter Partes Review proceeding to challenge Bristol Myers Squibb's U.S.formulation Pat. 8,476,239 for ORENCIA. The Company expects a decision from the PTAB in January 2017.
Necuparanib (novel oncology candidate)
- Momenta's 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 in the second half of 2017.
- Momenta continues to collect data from the Phase 1 study
of necuparanib and plans to present final data in a poster session at the upcoming
American Society of Clinical Oncology(ASCO) Annual Meeting in June 2016.
Momenta's 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 initiating clinical trials in 2016 for M281, and in 2017 for M230. The Company is continuing its efforts to identify and explore potential collaboration opportunities for the further development and commercialization of its hsIVIg program.
First Quarter 2016 Financial Results
Total revenues for the first quarter of 2016 were
Collaborative research and development revenue for the first quarter of 2016 was
The Company expects that collaborative research and development revenue earned by Momenta related to reimbursement from Baxalta and Sandoz will fluctuate from quarter to quarter in 2016 depending on research and development activities. The quarterly recognition of consideration under the Company's collaborations with Baxalta and Mylan is expected to be $2.4 million and
Research and development expenses for the first quarter of 2016 were
General and administrative expenses for the quarter ended
The Company's guidance for the first quarter of 2016 for operating expenses, excluding stock-based compensation expense and net of collaborative reimbursement revenues from Sandoz and Baxalta, was
Ended March 31,
|Share-based compensation (expense) income||(4,828||)||4,385|
|Less: Collaborative reimbursement||(1,686||)||(4,154||)|
|Add: Mylan collaboration cost-sharing||3,792||—|
Today, Momenta provided guidance that it expects operating expenses (which will be reported net of Mylan's share of collaboration expenses), excluding stock-based compensation expense and net of collaborative reimbursement revenues from Sandoz and Baxalta, to be approximately
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 84504921. 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 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
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 Company's ability to meet its development goals for 2016; expectations regarding long-term growth and sustainability; future operating expenses; program development and collaboration plans; timing of regulatory submissions, regulatory approvals and product launches; timing of clinical trials and the availability and announcement of clinical data; the timing of decisions related to patent litigation and other patent-related proceedings; expectations regarding collaborative research and development revenue earned by the Company; and expectations regarding quarterly amortization of consideration under the Company's collaborations. Forward-looking statements may be identified by words such as "continue," "target," "goal," "guidance," "plan," "potential," "estimate," "expect," "will," "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 Company's Annual Report on Form 10-K for the year ended December 31, 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 Company's 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.
|MOMENTA PHARMACEUTICALS, INC.|
|Unaudited Condensed Consolidated Balance Sheets|
|Cash and marketable securities||$||362,828||$||350,044|
|Liabilities and Stockholders' Equity|
|Deferred revenue, net of current portion||46,475||12,213|
|Other long-term liabilities||592||69|
|Total liabilities and stockholders' equity||$||435,423||$||421,040|
|Unaudited Condensed Statements of Operations and Comprehensive Loss|
|(in thousands, except per share amounts)|
Ended March 31,
|Research and development revenue||5,050||5,840|
|Total collaboration revenue||19,850||8,562|
|Research and development*||28,757||22,749|
|General and administrative*||15,647||7,890|
|Total operating expenses||44,404||30,639|
|Total other income||542||200|
|Basic and diluted net loss per share||$||(0.35||)||$||(0.40||)|
|Weighted average shares used in computing basic and diluted net loss per share||68,285||54,492|
|Net unrealized holding gains (losses) on available-for-sale marketable securities||133||18|
|* Non-cash share-based compensation (income) expense included in operating expenses is as follows:|
|Research and development||$||2,065||$||(2,215||)|
|General and administrative||$||2,763||$||(2,170||)|
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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