Momenta Pharmaceuticals Reports First Quarter 2017 Financial Results
--Company reports Glatopa® 20 mg product revenues of
--Ended the first quarter with a strong cash position of
"We continue to demonstrate the value of our Glatopa business both with increased revenues year-over-year for the 20 mg product and the potential of the 40 mg product to be launched this year," said
First Quarter Highlights and Recent Events
Glatopa 20 mg: First
- In the first
quarter of 2017, Momenta recorded
$23.4 millionin product revenues from Sandoz's Glatopa 20 mg sales compared to $14.8 millionin the same period in 2016.
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. On February 17, 2017, the Company announced that Sandoz's contracted fill/finish manufacturing partner for Glatopa, Pfizer, received an FDAwarning letter. An approval of the application may be dependent on the satisfactory resolution of the compliance observations stated in the FDAwarning letter issued to Pfizer. Pfizer 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.
January 30, 2017, the U.S. District Court of Delawarefound four of Teva Pharmaceutical's U.S.Orange Book listed patents for COPAXONE 40 mg to be invalid due to obviousness. On February 2, 2017, Teva filed a notice of appeal of the decision to the U.S. Court of Appeals for the Federal Circuit(CAFC). The Company expects a decision from the CAFCin late 2017 or early 2018.
- Teva has asserted infringement claims under two additional patents (
U.S.Patent Nos. 9,155,775 ("the ‘775 patent)" and 9,402,874 ("the ‘874 patent")), which claims Momenta believes to be invalid, not infringed and unenforceable. On April 23, 2017, the parties filed a joint motion to dismiss the suit for the '874 patent.
M923: a fully-owned proposed biosimilar to HUMIRA (adalimumab)
- In January, the Company received a one-time asset return payment of
$51.2 millionfrom Baxalta, a wholly-owned subsidiary of Shire plc, for the early termination of the M923 collaboration agreement.
- Momenta is targeting mid-2017 for the first submission for marketing approval of M923. Subject to marketing approval and patent considerations, the Company expects first commercial launch of M923 to be as early as the 2020 timeframe.
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 has appealed the decision to the CAFCand expects a decision in April 2018. A motion to dismiss the appeal is pending.
M710: a biosimilar candidate being developed in collaboration with Mylan
- The companies continue to progress M710 and expect to initiate a clinical trial for this program 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)
January 2017, the Company initiated the multiple ascending dose portion of the Phase 1 study in healthy volunteers. To date no serious adverse events have been observed. The Company plans to report the full 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
January 5, 2017, the Company announced that it entered into a worldwide license agreement and an exclusive research collaboration with CSL to develop and commercialize Fc multimer proteins, including Momenta's M230, which is expected to enter the clinic in 2017.
February 17, 2017the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act (HSR Act) in connection with the license agreement and research collaboration with CSL expired. Momenta received a $50 millionupfront cash payment from CSL in March 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.
First Quarter 2017 Financial Results
Revenue: In the first quarter of 2017, the Company recorded
Operating Expenses: Total GAAP operating expenses were
General and administrative expenses for the first quarter of 2017 were
First 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 figures. 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 Sandoz. 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 and excludes non-cash stock compensation expense and is net of collaborative reimbursement revenues from Sandoz. 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 annual 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 9265541. 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 seeking marketing approval; the timing of regulatory approval and launch of our product candidates, including Glatopa 40 mg; 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||$||433,749||$||353,151|
|Liabilities and Stockholders' Equity|
|Deferred revenue, net of current portion||29,653||31,360|
|Other long-term liabilities||4,960||3,793|
|Total liabilities and stockholders' equity||$||519,414||$||477,737|
Unaudited Condensed Statements of Operations and Comprehensive Loss
(in thousands, except per share amounts)
|Three Months Ended|
|Research and development revenue||3,210||5,050|
|Total collaboration revenue||26,614||19,850|
|Research and development*||36,101||28,757|
|General and administrative*||23,105||15,647|
|Total operating expenses||59,206||44,404|
|Basic and diluted net loss per share||$||(0.46||)||$||(0.35||)|
|Weighted average shares used in computing basic and |
diluted net loss per share
|* Non-cash shared-based compensation expense included in operating expenses is as follows:|
|Research and development||$||2,463||$||2,065|
|General and administrative||$||4,340||$||2,763|
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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