Momenta Pharmaceuticals Reports Fourth Quarter and Year End 2017 Financial Results and Provides Corporate Update
--Ended 2017 with a healthy cash position of
“In 2017 we made important progress, despite facing delays and challenges, and we are beginning to see the fruits of our diligent work pay off. With the recent approval and launch of Glatopa 40 mg, the significant advancements we've made across our novel drug portfolio, and the furthering of both M923, our biosimilar HUMIRA® candidate, and M710, our biosimilar EYLEA® candidate in collaboration with Mylan, we are well-positioned for a positive year ahead,” said
Wheeler continued, “Operationally, with Sandoz’s launch of Glatopa 40 mg we should gain more clarity on this product’s future revenue potential. The Glatopa 40 mg delay and the entry of another generic COPAXONE® 20 mg and 40 mg in 2017, however, has impacted our long-term ability to fund our broad and advancing product pipeline. We initiated a strategic review of our current business to proactively address this challenge, including the potential for new partnerships across our portfolio, additional cost reduction strategies, and the sale of certain assets. Momenta remains focused on maximizing shareholder value and I look forward to updating you on our progress.”
Fourth Quarter Highlights and Recent Events
Glatopa® 40 mg: a fully substitutable, AP-rated generic version of three-times-a-week COPAXONE 40 mg for patients with relapsing forms of multiple sclerosis developed in collaboration with
February 13, 2018, Momenta announced that the FDAhad approved Sandoz'sAbbreviated New Drug Application for Glatopa 40 mg and that Sandozinitiated the launch of the product in the US.
Glatopa® 20 mg: First
- In the fourth quarter of 2017, Momenta recorded
$13.0 millionin product revenues from Sandoz’s sales of Glatopa 20 mg, reflecting $13.6 millionin profit share, net a deduction of $0.6 millionin reimbursement to Sandozfor the Company's share of Glatopa-related legal expenses.
Enoxaparin Sodium Injection: First
February 7, 2018, the U.S. District Court of Massachusettsissued its decision in the Company’s patent litigation against Amphastar involving U.S. Patent No. 7,575,886, covering methods for the manufacturing control of generic LOVENOX. In July 2017, the jury in this case issued its verdict finding that the Company’s ‘886 patent was infringed by two separate methods used by Amphastar, but invalid for lack of written description and enablement. The jury also provided the court with an advisory verdict recommending that the court find the patent unenforceable by the Company against Amphastar for both of their infringing methods. This recent court decision narrows the advisory verdict finding the patent to be unenforceable against only one of the two infringing methods used by Amphastar. The Company is evaluating its plans for appeal.
- In the fourth quarter of 2017, Momenta recorded
$0.3 millionin product revenue on Sandoz'ssales of Enoxaparin Sodium Injection.
M923: a fully-owned proposed biosimilar to HUMIRA® (adalimumab)
January 2018, the Company announced that the Biologics License Application (BLA) for M923 is prepared to be filed with the FDA. At this time, the timing of Momenta’s filing of the BLA is dependent on the identification of a collaboration partner for M923.
M834: a proposed biosimilar to ORENCIA® (abatacept) being developed in collaboration with Mylan
November 2017, Momenta 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 investigate these results in order to determine the next steps for the program.
M710: a proposed biosimilar to EYLEA® (aflibercept) candidate being developed in collaboration with Mylan
January 2018, Momenta and Mylan disclosed that M710 is a proposed biosimilar to EYLEA.
- An Investigational New Drug (IND) application has been accepted and the companies plan to initiate a pivotal clinical trial in patients in the first half of 2018.
Novel Drugs for Autoimmune Indications:
M281 (anti-FcRn): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb)
January 2018, the Company reported positive top-line data showing safety, tolerability and proof of mechanism for M281 in a phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study of normal human volunteers. Over the 98-day MAD study, M281 exhibited no serious adverse events, was well tolerated, and decreased circulating IgG levels up to 89% with a mean reduction of 84%.
- Momenta is finalizing its development strategy for M281 and is planning to initiate a proof of concept clinical trial in the second half of 2018, pending regulatory feedback.
M230 (CSL730): a recombinant Fc multimer being developed in collaboration with CSL
- In late
January 2018, CSL began dosing subjects in the Phase 1 trial in healthy volunteers to evaluate the safety and tolerability of M230. The Phase 1 study is expected to be completed within one year.
M254 (hsIVIg): a hyper-sialylated immunoglobulin designed as a high potency alternative for intravenous immunoglobulin (IVIg) to remediate limitations of that therapeutic approach
- The Company began an IND-enabling toxicology study in the fourth quarter of 2017 and is targeting the initiation of a clinical trial in the second half of 2018.
Fourth Quarter and Year End 2017 Financial Results
Revenue: In the fourth quarter of 2017, the Company recorded
Research and development revenue for the fourth quarter of 2017 was
Total revenues for the fourth quarter of 2017 were
Operating Expenses: Total GAAP operating expenses were
Research and development expenses for the fourth quarter of 2017 were
General and administrative expenses for the fourth quarter of 2017 were
Fourth quarter non-GAAP operating expense was
Net Income (Loss): The Company reported a net income of
Cash Position: At December 31, 2017, Momenta had
2018 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 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 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 “2018 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 6799797. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through 6799797. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 6799797.
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; development timelines, including next steps for M834; the Company’s ability to meet its development and strategic goals; market potential and product revenues of our products and product candidates, including the potential future revenue from Glatopa 40 mg profits; our strategic review; timing of clinical trials and the timing, availability and announcement of data and results; future legal proceedings; 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; and anticipated collaborative reimbursement revenues. 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 September 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.
MacDougall Biomedical Communications
MOMENTA PHARMACEUTICALS, INC.
Unaudited Condensed Consolidated Balance Sheets
|December 31, 2017||December 31, 2016|
|Cash, cash equivalents and marketable securities||379,890||353,151|
|Liabilities and Stockholders’ Equity|
|Deferred revenue, net of current portion||30,751||31,360|
|Other long-term liabilities||10,039||3,793|
|Total liabilities and stockholders’ equity||$||459,431||$||477,737|
Unaudited Condensed Statements of Operations and Comprehensive Income (Loss)
(in thousands, except per share amounts)
|Three Months Ended
|Research and development revenue||51,239||18,378||72,079||34,971|
|Total collaboration revenue||64,608||34,195||138,882||109,619|
|Research and development||36,148||26,382||149,226||119,880|
|General and administrative||15,827||18,165||82,207||64,466|
|Total operating expenses||51,975||44,547||231,433||184,346|
|Income (loss) from operations||12,633||(10,352||)||(92,551||)||(74,727||)|
|Other income, net||1,126||51,891||4,455||53,724|
|Net income (loss)||$||13,759||$||41,539||$||(88,096||)||$||(21,003||)|
|Net income (loss) per share:|
|Shares used in calculating net income (loss) per share|
|Comprehensive income (loss)||$||13,572||$||41,375||$||(88,322||)||$||(20,921||)|
Reconciliation of GAAP Results to Non-GAAP Financial Measures
A reconciliation of historical GAAP operating expenses to Non-GAAP operating expenses is as follows:
|Three Months Ended
|GAAP operating expenses||$||51,975||$||44,547||$||231,433||$||184,346|
|Non-cash stock compensation expense||183||(3,566||)||(16,127||)||(18,322||)|
|Collaboration expenses that are recorded as revenue and are reimbursable by collaborators||(523||)||(1,961||)||(7,064||)||(6,620||)|
|Non-GAAP operating expenses||$||51,635||$||39,020||$||208,242||$||159,404|
Source: Momenta Pharmaceuticals, Inc.