Momenta Pharmaceuticals Reports Second Quarter 2017 Financial Results and Provides Corporate Update
Ended second quarter with a strong cash position of
"In the second quarter Glatopa 20 mg continued to provide us with steady funding and recently earned us a
Second Quarter Highlights and Recent Events
Glatopa 20 mg: First
- In the second quarter of 2017, Momenta recorded
$19.1 millionin product revenues from Sandoz's Glatopa 20 mg sales, net a deduction of $0.6 millionfor reimbursement to Sandoz of the Company's share of Glatopa-related legal expenses, compared to $20.7 millionin the same period in 2016.
July 1, 2017, Momenta earned a $10 millionmilestone payment from Sandoz in connection with Glatopa 20 mg continuing to be the sole FDA-approved generic of COPAXONE 20 mg and achieving a certain level of contractually defined profits 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 may be 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 an approval from the FDAcontinues to be possible in 2017.
Enoxaparin Sodium Injection: First
July 21, 2017, the jury in the U.S. District Court of Massachusettsin Bostonissued its verdict finding that the Company's U.S.Patent No. 7,575,886, covering methods for the manufacturing control of generic LOVENOX, was infringed by Amphastar, but invalid and unenforceable. The Company is considering all available legal options to overturn the verdict, including post-trial motions and appeals. Final judgment has not yet been entered.
M923: a fully-owned proposed biosimilar to HUMIRA (adalimumab)
- Momenta is working toward the first submission for marketing approval of M923 in the fourth quarter of 2017. The Company is preparing for a first commercial launch of M923 as early as the 2020 timeframe, subject to marketing approval and patent considerations.
M834: a proposed biosimilar to ORENCIA (abatacept) being developed in collaboration with Mylan
April 2017, the Phase 1 clinical trial for M834 completed enrollment. The companies plan to report top-line data from the Phase 1 trial in the second half of 2017.
December 22, 2016, the U.S.Patent and Trademark Office's Patent Trial and Appeal Board issued their decision upholding the validity of U.S.Patent No. 8,476,239, related to Bristol Myers Squibb's ORENCIA product following the Company's Inter Partes Review challenging this patent. The Company appealed the decision to the CAFC, and in June 2017a motion filed by Bristol Myers Squibb to dismiss the Company's appeal was denied. The Court has expedited the appeal process providing the potential for a hearing in the fourth quarter of 2017.
M710: a biosimilar candidate being developed in collaboration with Mylan
- The companies continue to progress M710 and are targeting a first regulatory submission for clinical development in late 2017 or early 2018.
Novel Drugs for Autoimmune Indications:
M281 (anti-FcRn): a fully human monoclonal antibody (mAb) targeting the neonatal Fc receptor (FcRn)
- The Company expects to complete the multiple ascending dose portion of the Phase 1 study in healthy volunteers in
August 2017. To date no serious adverse events have been observed. The Company plans to report the data from the single and multiple ascending dose portions of the study in the second half of 2017.
M230 (SIF3): a Selective Immunomodulator of Fc receptors being developed in collaboration with CSL
- Momenta and CSL have agreed upon a development plan for M230 which is expected to enter the clinic in 2017.
- Under the agreement with CSL, Momenta has the option to elect a 50% cost and profit sharing arrangement for M230, for which Momenta would fund 50% of global research and development and
U.S.commercialization and manufacturing costs in exchange for 50% of U.S.profits, plus milestones and royalties outside the United States. The Company is required to make its decision on the 50% cost and profit sharing option in the third quarter of 2017.
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.
Second Quarter 2017 Financial Results
Revenue: In the second quarter of
2017, the Company recorded
Operating Expenses: Total GAAP operating expenses were
General and administrative expenses for the second quarter of 2017 were
Second 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 collaboration expenses incurred by the Company that are reimbursable by collaborative partners. Today, Momenta is providing updated non-GAAP operating expense guidance of approximately
The Company continues to expect to recognize revenue from Mylan's
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 collaboration expenses incurred by the Company that are reimbursable by collaborative partners. 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 a 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 anticipated 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 48279630. 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;
the dependence of an approval of the Glatopa 40 mg ANDA on resolution of the compliance observations in the
|MOMENTA PHARMACEUTICALS, INC.|
|Unaudited Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and marketable securities||$||456,824||$||353,151|
|Liabilities and Stockholders' Equity|
|Deferred revenue, net of current portion||30,761||31,360|
|Other long-term liabilities||5,128||3,793|
|Total liabilities and stockholders' equity||$||540,806||$||477,737|
|Unaudited Condensed Statements of Operations and Comprehensive Loss|
|(in thousands, except per share amounts)|
|Three Months Ended||Six Months Ended|
|Research and development revenue||4,430||5,738||7,640||10,788|
|Total collaboration revenue||23,570||26,430||50,184||46,280|
|Research and development||39,063||33,173||75,164||61,930|
|General and administrative||22,572||14,896||45,677||30,543|
|Total operating expenses||61,635||48,069||120,841||92,473|
|Other income, net||1,157||653||1,990||1,195|
|Net loss per share basic and diluted||$||(0.50||)||$||(0.31||)||$||(0.96||)||$||(0.66||)|
|Weighted average number of common shares|
used in net loss per share basic and diluted
|Reconciliation of GAAP Results to Non-GAAP Financial Measures|
|A reconciliation of historical GAAP operating expenses to Non-GAAP operating expenses is as follows:|
Ended||Six Months Ended|
|GAAP operating expenses||$||61,635||$||48,069||$||120,841||$||92,473|
|Non-cash stock compensation expense||(4,590||)||(4,989||)||(11,393||)||(9,817||)|
|Collaboration expenses that are reimbursable|
|Non-GAAP operating expenses||$||53,996||$||41,627||$||104,985||$||79,517|
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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