Momenta Pharmaceuticals Reports Third Quarter 2017 Financial Results and Provides Corporate Update
-- Ended third quarter with a strong cash position of
"We continue to believe in the potential for the approval and launch of Glatopa® 40 mg in late 2017 or early 2018 and that there remains a meaningful market opportunity for this product in the U.S.," said
Third Quarter Highlights and Recent Events
Glatopa® 20 mg: First
- In the third quarter of 2017, Momenta recorded
$10.9 millionin product revenues from Sandoz's Glatopa 20 mg sales.
- In the third quarter of 2017, Momenta earned a
$10 millionmilestone payment from Sandoz in connection with Glatopa 20 mg's status at that time as the sole FDA-approved generic of COPAXONE 20 mg in the U.S.two years following its launch.
Glatopa 40 mg: Designed to be a generic version of three-times-a-week COPAXONE 40 mg for patients with relapsing forms of multiple sclerosis developed in collaboration with Sandoz
- The Abbreviated New Drug Application (ANDA) submitted by Sandoz is under
U.S. Food and Drug Administration(FDA) review. An approval of the application is dependent on the satisfactory resolution of the compliance observations stated in the FDAwarning letter issued in February 2017to Pfizer, the contracted fill/finish manufacturing partner for Glatopa. Pfizer has submitted a comprehensive response to the observations cited in the warning letter. The Company believes that marketing approval from the FDAcontinues to be possible in late 2017 or early 2018.
M923: a fully-owned proposed biosimilar to HUMIRA (adalimumab)
- Momenta is working toward the first submission for marketing approval of M923 in late 2017. The Company expects first U.S. market formation for biosimilar versions of HUMIRA to begin in the 2022 - 2023 timeframe subject to marketing approval, patent considerations and litigation timelines.
M834: a proposed biosimilar to ORENCIA (abatacept) being developed in collaboration with Mylan
- Momenta today announced that M834 did not meet its primary pharmacokinetic endpoints in a Phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced ORENCIA in normal healthy volunteers. Momenta and Mylan continue to gather and analyze these data to inform the next steps for the program.
M710: a biosimilar candidate being developed in collaboration with Mylan
- Momenta and Mylan continue to progress M710 and are targeting a first regulatory submission for clinical development by early 2018.
Novel Drugs for Autoimmune Indications:
M281 (anti-FcRn): a fully human monoclonal antibody (mAb) targeting the neonatal Fc receptor (FcRn)
August 2017, the Company completed the multiple ascending dose portion of the Phase 1 study in healthy volunteers. The Company plans to report the top-line data from the multiple ascending dose portion of the study in the fourth quarter of 2017.
M230 (SIF3): a Selective Immunomodulator of Fc receptors being developed in collaboration with CSL
September 2017, Momenta announced that it opted into a 50% cost and profit sharing arrangement for all products developed under the CSL agreement, including M230. Under the agreement Momenta will fund 50% of global research and development and U.S.commercialization and manufacturing costs in exchange for 50% of U.S.profits. Royalties remain payable to Momenta for territories outside the U.S.and milestones are reduced.
- Momenta and CSL have agreed upon a development plan for M230 and CSL is targeting a clinical trial in late 2017, subject to regulatory feedback.
M254 (hsIVIg): a robust, controlled sialylation process to generate tetra-Fc-sialylated immunoglobulins with consistent enhanced anti-inflammatory activity
- The Company continues to progress the M254 program and expects to initiate an IND-enabling toxicology study in 2017 and is targeting a clinical trial in 2018.
Third Quarter 2017 Financial Results
Revenue: In the third quarter of 2017, the Company recorded
Research and development revenue for the third quarter of 2017 was
Total revenues for the third quarter of 2017 were
Operating Expenses: Total GAAP operating expenses were
General and administrative expenses for the third quarter of 2017 were
Third quarter non-GAAP operating expense was
Net Loss: The Company reported a net loss of
Cash Position: At
2017 Financial Guidance
Momenta provides non-GAAP operating expense guidance, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP financial measures. 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 collaborative reimbursement revenues. Today, Momenta is providing updated non-GAAP operating expense guidance of approximately
The Company expects to recognize the
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 as it excludes non-cash stock compensation expense and collaborative reimbursement revenues. This non-GAAP financial measure should not be considered a substitute or an alternative to GAAP total operating expense and should not be considered a measure of Momenta's liquidity. Instead, non-GAAP operating expense should only be used to supplement an understanding of Momenta's operating results as reported under GAAP. Momenta has not provided GAAP reconciliation for its forward-looking non-GAAP annual or quarterly 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 estimated reconciling information that is available without unreasonable effort in the section of this press release above entitled "2017 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 6492819. 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 our regulatory filings for clinical development and marketing approval; the timing of regulatory approval and launch of our product candidates, including Glatopa 40 mg; development timelines; the Company's ability to meet its development and strategic goals; market potential and product revenues of our products and product candidates; the contribution of our Chief Operating Officer; timing of biosimilar market formation; the next steps for M834; timing of clinical trials and the timing, availability and announcement of data and results; the CSL cost and profit sharing arrangement; expectations regarding accounting treatment for and recognition of consideration and revenues under the Company's collaborations; reconciling information; non-GAAP operating expense guidance; anticipated collaborative reimbursement revenues and anticipated spend on M923 and its inclusion in operating expenses. Forward-looking statements may be identified by words and phrases such as "advance," "anticipate," 'being developed," "believe," "continue," "expect," "guidance," "look forward to," "may," "plan," "possible," "potential," "progress," "propose," "remains," "target," "will," "working toward" 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, 2017, 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||$||423,078||$||353,151|
|Liabilities and Stockholders' Equity|
|Deferred revenue, net of current portion||29,845||31,360|
|Other long-term liabilities||5,924||3,793|
|Total liabilities and stockholders' equity||$||502,542||$||477,737|
|Unaudited Condensed Statements of Operations and Comprehensive Loss|
|(in thousands, except per share amounts)|
|Three Months Ended||Nine Months Ended|
|Research and development revenue||13,200||5,805||20,840||16,593|
|Total collaboration revenue||24,090||29,144||74,274||75,424|
|Research and development||37,914||31,568||113,078||93,498|
|General and administrative||20,703||15,758||66,380||46,301|
|Total operating expenses||58,617||47,326||179,458||139,799|
|Other income, net||1,339||638||3,329||1,833|
|Net loss per share basic and diluted||$||(0.44||)||$||(0.26||)||$||(1.40||)||$||(0.91||)|
|Weighted average number of common shares used in net loss per share basic and diluted||74,611||68,799||72,585||68,540|
|Reconciliation of GAAP Results to Non-GAAP Financial Measures|
|A reconciliation of historical GAAP operating expenses to Non-GAAP operating expenses is as follows:|
|Three Months Ended||Nine Months Ended|
|GAAP operating expenses||$||58,617||$||47,326||$||179,458||$||139,799|
|Non-cash stock compensation expense||(4,916||)||(4,939||)||(16,309||)||(14,756||)|
|Collaboration expenses that are reimbursable by collaborators||(2,078||)||(1,522||)||(6,541||)||(4,661||)|
|Non-GAAP operating expenses||$||51,623||$||40,865||$||156,608||$||120,382|
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