Momenta Pharmaceuticals Reports First Quarter 2019 Financial and Operating Results
— M281 Phase 2 trials in MG and HDFN active and enrolling patients —
— Data supporting M281’s mechanism in HDFN, as first anti-FcRn antibody to inhibit maternal-fetal IgG transfer in perfusion model of the human term placenta, published in
— First subjects dosed in Phase 1/2 M254 and IVIg crossover clinical trial in ITP —
“We continue to focus on operational execution to progress our ongoing trials of M281 and M254 towards key proof-of-concept data readouts in 2020,” said
First Quarter 2019 Highlights, Recent Events and Anticipated Upcoming Milestones
Novel Therapeutics Pipeline:
M281 (anti-FcRn): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb)
- Vivacity-MG, the Company’s Phase 2 study of M281 in generalized Myasthenia Gravis (gMG), is expected to report top-line results in 2020. Unity, the Company’s global multi-center Phase 2 clinical study of M281 in Hemolytic Disease of the Fetus and Newborn (HDFN), is expected to report top-line results in 2021. This follows the
March 2019announcement that regulatory approvals were obtained in the U.S., Canadaand several EU countries and that the Company began activating clinical sites.
March 2019, the Company published data in the American Journal of Obstetrics & Gynecology, expanding on its February 2019presentation at the Society for Maternal-Fetal Medicine39th Annual Pregnancy Meeting, which highlighted the ability of M281 to inhibit transfer of immunoglobulin G from maternal to fetal circulation in an ex vivo placental perfusion model with minimal transfer of M281 into fetal circulation.
- The Company plans to initiate a third study of M281 in an additional autoimmune indication in 2019.
M254 (hsIgG): a hypersialylated immunoglobulin designed as a high potency alternative for intravenous immunoglobulin (IVIg)
- In January 2019, the Company announced that the first subject was dosed in the Phase 1/2 clinical trial in idiopathic thrombocytopenic purpura (ITP). The multi-part trial is first enrolling healthy volunteers and includes single and multiple dose studies, and a randomized cross-over study comparing M254 to IVIg. Enrollment for this trial is ongoing and preliminary clinical data is expected in 2020.
M230 (CSL730): a recombinant Fc multimer being developed in collaboration with CSL
- The Phase 1 clinical trial in healthy volunteers to evaluate the safety and tolerability of M230 continues. Momenta’s partner, CSL expects to complete the Phase 1 study by the end of 2019.
SIFbody Platform and Fc Multimerization Technology:
- The Company presented two posters at the
American Association for Cancer Research(AACR) Annual Meeting in April 2019, demonstrating the potential of its SIFbody platform and Fc multimerization technology to significantly enhance the potency and efficacy of a variety of cell depleting therapeutic antibodies, including antibodies targeting CD38 and CTLA-4.
Glatopa® 20 mg and 40 mg:
- In the first quarter of 2019, Momenta recorded
$2.4 millionin product revenue from Sandoz’s sales of Glatopa products.
M923: a fully-owned proposed biosimilar to HUMIRA® (adalimumab)
- In November 2018, the Company announced license agreements with
AbbVie, providing worldwide rights for the launch of M923. Under the terms of the agreements, and subject to approval by health regulatory authorities, Momenta may launch M923 worldwide based on agreed-to launch dates, including in the U.S. in November 2023. Momenta is currently seeking a commercialization partner for this product.
M710: a proposed biosimilar to EYLEA® (aflibercept) candidate being developed in collaboration with Mylan
- Mylan continues its pivotal clinical trial in patients with diabetic macular edema to compare safety, efficacy and immunogenicity of M710 with EYLEA.
January 2019, Momenta’s formal notice of termination for all other biosimilar candidates previously subject to the collaboration agreement with Mylan became effective.
First Quarter 2019 Financial Results
Revenue: In the first quarter of 2019, the Company recorded
Research and development revenue for the first quarter of 2019 was
Total revenue for the first quarter of 2019 was
Operating Expenses: Total GAAP operating expenses were
Research and development expenses for the first quarter of 2019 were
General and administrative expenses for the first quarter of 2019 were
First quarter 2019 non-GAAP operating expense was
Net Income (Loss): The Company reported a net loss of
Cash Position: At
2019 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, less stock-based compensation expense, restructuring expense and collaborative reimbursement revenue. Momenta re-affirms its quarterly non-GAAP operating expense guidance of
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, restructuring expense and collaborative reimbursement revenue. 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 “2019 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 8949569. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through 8949569. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 7484068.
To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release.
The Company’s 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; the Company’s ability to meet its development and strategic goals; market potential and revenue of our products and product candidates, design, timing and goals of clinical trials and the availability, timing and announcement of data and results; the use, efficacy, safety, potency, tolerability, convenience and commercial potential of our product candidates, including their potential as best-in-class agents; future legal proceedings; expectations regarding accounting treatment for and recognition of consideration and revenue under the Company’s collaborations; reconciling information; non-GAAP operating expense guidance; and anticipated collaborative reimbursement revenue. 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
|INVESTOR CONTACT:||MEDIA CONTACT:|
|Patty Eisenhaur||Karen Sharma|
|Momenta Pharmaceuticals||MacDougall Biomedical Communications|
MOMENTA PHARMACEUTICALS, INC.
Unaudited Condensed Consolidated Balance Sheets
|March 31, 2019||December 31, 2018|
|Cash, cash equivalents and marketable securities||$||416,453||$||449,411|
|Liabilities and Stockholders’ Equity|
|Deferred revenue, net of current portion||743||1,774|
|Other long-term liabilities||83,569||17,270|
|Total liabilities and stockholders’ equity||$||558,450||$||531,563|
MOMENTA PHARMACEUTICALS, INC.
Unaudited Condensed Statements of Operations and Comprehensive Loss
(in thousands, except per share amounts)
|Three Months Ended March 31,|
|Research and development revenue||1,761||1,331|
|Total collaboration revenue||4,113||4,852|
|Research and development||27,972||33,242|
|General and administrative||24,206||20,612|
|Total operating expenses||52,204||53,854|
|Loss from operations||(48,091||)||(49,002||)|
|Other income, net||3,248||1,371|
|Net loss per share:|
|Basic and diluted||$||(0.46||)||$||(0.63||)|
|Shares used in calculating net loss per share|
|Basic and diluted||98,195||75,454|
MOMENTA PHARMACEUTICALS, INC.
Reconciliation of GAAP Results to Non-GAAP Financial Measures
A reconciliation of historical GAAP operating expenses to Non-GAAP operating expenses is as follows:
|Three Months Ended March 31,|
|GAAP operating expenses||$||52,204||$||53,854|
|Non-cash stock compensation expense||(3,474||)||(4,874||)|
|Collaboration expenses that are recorded as revenue and are reimbursable by collaborators||(420||)||(583||)|
|Non-GAAP operating expenses||$||48,284||$||48,397|
Source: Momenta Pharmaceuticals, Inc.