Momenta Pharmaceuticals Reports Third Quarter 2016 Financial Results
--Initiates Phase 1 trial for M834, biosimilar ORENCIA® (abatacept) candidate--
For the third quarter of 2016, the Company reported total revenues of
"Our biosimilars collaboration with Mylan continues to
advance. Today we announced the initiation of a Phase 1 trial for our lead candidate, M834, a biosimilar version of ORENCIA®. We also recently re-gained the rights to M923, our biosimilar HUMIRA® candidate, and believe this is a real opportunity for us to generate additional value from this product," said
Third Quarter Highlights and Recent Events
- In the third quarter of 2016,
$23.3 millionin product revenues from Sandoz's Glatopa sales.
- The Abbreviated New Drug Application (ANDA) submitted by Sandoz for a three-times-a-week generic COPAXONE® 40 mg (glatiramer acetate injection) is under
U.S. Food and Drug Administration(FDA) review. The Company expects to receive tentative regulatory approval in the next few months.
- A district court trial challenging four of Teva's five Orange Book-listed patents for COPAXONE 40 mg (glatiramer acetate injection) concluded on
October 6, 2016. The Company expects a decision to be issued in the first quarter of 2017.
- Momenta and its collaboration partner Mylan today announced the
initiation of a Phase 1 clinical trial for M834, a biosimilar ORENCIA (abatacept) candidate. Under the Mylan collaboration agreement, Momenta achieved a regulatory milestone thereby earning a
$25.0 millionpayment from Mylan. The companies plan to report top-line data from the trial by the end of 2017.
- In September, the
U.S. Patent and Trademark Officeheld a hearing in Inter Partes Review (IPR) proceedings for the Company's challenge of the validity of Bristol Myers Squibb's U.S.Patent No. 8,476,239 covering formulations of ORENCIA which is set to expire in 2028. The Patent Office's decision is due by January 15, 2017.
- In September, Momenta regained global development and commercialization rights to M923, a biosimilar HUMIRA (adalimumab) candidate. Shire exercised its right to terminate the collaboration agreement for M923 following its combination with Baxalta. Under the terms of the collaboration, the agreement will terminate twelve months following the notice, and Shire is obligated to fund the M923 program until termination. The Company plans to release top-line results from the Phase 3 clinical trial for M923 in late 2016, and the first regulatory submission for marketing approval is planned for mid-2017. Subject to marketing approval and patent considerations, the Company expects first commercial launch of M923 to be as early as 2018.
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. The Company has initiated a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of M281 in healthy subjects and expects to report data in the second half of 2017. M230 is in pre-clinical development, and the Company expects to initiate a clinical trial for M230 in 2017. Momenta is also developing a hyper-sialylated IVIg (M254) as a potential high potency version of IVIg. The Company continues its efforts to identify potential collaboration opportunities for the further development and commercialization of its novel drug candidates for autoimmune indications.
The Company announced today the appointment of
Third Quarter 2016 Financial Results
Total revenues for the third quarter of 2016 were
Collaborative research and development revenue for the third quarter of 2016 was
Research and development expenses for the third quarter of 2016 were
General and administrative expenses for the quarter ended
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.
Today, Momenta reiterated its non-GAAP operating expense guidance of 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 99282531. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through
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 and Baxalta. 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 fourth quarter 2016 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."
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 Company's ability to meet its development goals; expectations regarding long-term growth and sustainability; future operating expenses; program development and collaboration plans; timing of regulatory submissions, tentative approvals, regulatory approvals and product launches; expected start date of the Company's recently appointed Chief Financial Officer; timing of clinical trials and the availability and announcement of clinical data; timing of patent litigation and other patent-related proceedings and decisions related to such litigation and proceedings; ability to generate value from our product candidates; timing of termination of the collaboration agreement with Baxalta; and expectations regarding quarterly recognition of consideration under the Company's collaborations. Forward-looking statements may be identified by words such as "believe," "continue," "expect," "guidance," "opportunity," "plan," "possible," "potential," "will" 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, 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, cash equivalents and marketable securities||$||308,958||$||350,044|
|Liabilities and Stockholders' Equity|
|Deferred revenue, net of current portion||33,310||12,213|
|Other long-term liabilities||1,858||69|
|Total liabilities and stockholders' equity||$||409,110||$||421,040|
Unaudited Condensed Statements of Operations and Comprehensive Loss
(in thousands, except per share amounts)
Ended September 30,
Ended September 30,
|Research and development revenue||5,805||5,129||16,593||36,565|
|Total collaboration revenue||29,144||13,795||75,424||67,258|
|Research and development*||31,568||31,733||93,498||88,466|
|General and administrative*||15,758||12,459||46,301||33,678|
|Total operating expenses||47,326||44,192||139,799||122,144|
|Basic and diluted net loss per share||$||(0.26||)||$||(0.44||)||$||(0.91||)||$||(0.88||)|
|Weighted average shares used in computing basic and diluted net loss per share||68,799||68,004||68,540||61,442|
|* Non-cash share-based compensation expense included in operating expenses is as follows:|
|Research and development||$||2,042||$||2,122||$||6,426||$||3,031|
|General and administrative||$||2,897||$||2,435||$||8,330||$||3,756|
Sarah Carmody Momenta Pharmaceuticals1-617-395-5189 IR@momentapharma.com MEDIA CONTACT: Karen Sharma MacDougall Biomedical Communications1-781-235-3060 Momenta@macbiocom.com
News Provided by Acquire Media