Momenta Pharmaceuticals Reports First Quarter 2018 Financial Results and Provides Corporate Update
“We made important progress in the first quarter of 2018 across our complex generic, biosimilar and novel drug portfolios. Importantly, Glatopa 40 mg/mL received
Wheeler continued, “The strategic review of our business announced earlier this year is active and we are evaluating options for our business including the potential for new partnerships across the portfolio or the sale of one or more of our biosimilar assets. We expect to complete this strategic review by the end of the second quarter of 2018.”
First Quarter Highlights and Recent Events
Glatopa® Products: a fully substitutable, AP-rated generic version of three-times-a-week COPAXONE® 40 mg/mL and daily COPAXONE 20 mg/mL (glatiramer acetate injection) 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/mL and that Sandozinitiated the launch of the product in the US. Sandozhas secured customer contracts and orders of Glatopa 40 mg/mL have been shipped. Sandozhad to build inventory of Glatopa 40 mg/mL for the US launch and expects accelerated adoption by customers as the year progresses.
- In the first quarter of 2018, Momenta recorded
$3.5 millionin product revenues from Sandoz’s sales of Glatopa 20 mg/mL and 40 mg/mL products, reflecting $13.3 millionin profit share, net a deduction of $9.8 millionin the first quarter of 2018 for 50% of Glatopa 40 mg/mL inventory reserves.
Enoxaparin Sodium Injection: First
March 20, 2018, the US District Court of Massachusettsissued its final judgment affirming its February 2018decision in the Company’s patent litigation against Amphastar involving US Patent No. 7,575,886, covering methods for the manufacturing control of generic LOVENOX, 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. Momenta and Sandozhave appealed the case to the Court of Appeals for the Federal Circuit. Amphastar has moved to seek damages under the bond posted in connection with the preliminary injunction granted in 2010. Momenta and Sandozhave opposed the motion as premature pending a final ruling on appeal.
March 20, 2018, the US District Court of Massachusettsalso denied Momenta and Sandoz’s motion to dismiss Amphastar’s antitrust lawsuit. A trial is scheduled for September 2019. Momenta has filed a motion to certify the denial of the motion to dismiss as eligible for interlocutory appeal on the grounds that dismissal is warranted under law and an appeal at this time could resolve the case.
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. The timing of Momenta’s filing of the BLA is dependent on the outcome of the Company’s ongoing strategic review.
M834: a proposed biosimilar to ORENCIA® (abatacept) being developed in collaboration with Mylan
- In late 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 and announced IND acceptance by the FDA. The companies plan to start-up the pivotal clinical trial in patients in the first half of 2018.
Novel Drugs for Rare Autoimmune and Immune-mediated Diseases:
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 in 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 two proof of concept clinical trials 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 targeted to be completed in 2019.
M254 (hsIVIg): a hyper-sialylated immunoglobulin designed to be a higher potency alternative to intravenous immunoglobulin (IVIg) with the potential for enhanced safety and convenience
- The Company is on track to complete the IND-enabling toxicology study this year and is targeting the initiation of a clinical trial in the second half of 2018.
First Quarter 2018 Financial Results
Revenue: In the first quarter of 2018, the Company recorded
Research and development revenue for the first quarter of 2018 was
Total revenues for the first quarter of 2018 were
Operating Expenses: Total GAAP operating expenses were
Research and development expenses for the first quarter of 2018 were
General and administrative expenses for the first quarter of 2018 were
First quarter non-GAAP operating expense was
Net Loss: The Company reported a net loss of
Cash Position: At March 31, 2018, 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 reiterating 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 7665388. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through 7665388. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 7665388.
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 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; timing of clinical trials and the timing, availability and announcement of data and results; future legal proceedings; expectations regarding accounting treatment for and recognition of consideration and revenues under the Company’s collaborations; reconciling information; non-GAAP operating expense guidance; our strategic business review 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 Annual Report on Form 10-K for the year ended December 31, 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|
|March 31, 2018||December 31, 2017|
|Cash, cash equivalents and marketable securities||$||346,008||$||379,890|
|Liabilities and Stockholders’ Equity|
|Deferred revenue, net of current portion||34,890||30,751|
|Other long-term liabilities||13,125||10,039|
|Total liabilities and stockholders’ equity||$||416,944||$||459,431|
|MOMENTA PHARMACEUTICALS, INC.|
|Unaudited Condensed Statements of Operations and Comprehensive Loss|
|(in thousands, except per share amounts)|
|Three Months Ended March
|Research and development revenue||1,331||3,210|
|Total collaboration revenue||4,852||26,614|
|Research and development||33,242||36,101|
|General and administrative||20,612||23,105|
|Total operating expenses||53,854||59,206|
|Loss from operations||(49,002||)||(32,592||)|
|Other income, net||1,371||833|
|Net loss per share:|
|Basic and diluted||$||(0.63||)||$||(0.46||)|
|Shares used in calculating net loss per share|
|Basic and diluted||75,454||69,711|
|MOMENTA PHARMACEUTICALS, INC.|
|Reconciliation of GAAP Results to Non-GAAP Financial Measures|
|A reconciliation of historical GAAP operating expenses to Non-GAAP operating expenses is as follows:|
|Three Months Ended
|GAAP operating expenses||$||53,854||$||59,206|
|Non-cash stock compensation expense||(4,874||)||(6,803||)|
|Collaboration expenses that are recorded as revenue and are reimbursable by collaborators||(583||)||(1,415||)|
|Non-GAAP operating expenses||$||48,397||$||50,988|
Source: Momenta Pharmaceuticals, Inc.