Momenta Pharmaceuticals Reports Third Quarter 2019 Financial and Operating Results
“Our focus in 2019 is on the execution of our clinical programs as they advance toward proof of concept,” said
Third Quarter 2019 Highlights, Recent Events and Anticipated Upcoming Milestones
Novel Therapeutics Pipeline:
Nipocalimab (M281): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb)
- Vivacity-MG, the Company’s Phase 2 clinical study of nipocalimab in generalized myasthenia gravis (gMG), continues to enroll patients. The Company expects to report top-line data from this study in the second or third quarter of 2020.
- Unity, the Company’s global multi-center Phase 2 clinical study of nipocalimab in hemolytic disease of the fetus and newborn (HDFN), is active and enrolling patients. Nipocalimab has been granted Fast Track designation by the
U.S. Food and Drug Administration( FDA) for this indication and the Company expects to report top-line from this study data in 2021.
- Energy, the Company’s adaptive Phase 2/3 clinical study of nipocalimab in Warm Autoimmune Hemolytic Anemia (wAIHA) commenced in the third quarter 2019. The Company is activating clinical sites in both the
United States and European Unionand is actively recruiting patients. Nipocalimab has been granted Fast Track designation by the FDAin this indication and the Company expects to report top-line data from this study around the end of 2021.
M254 (hsIgG): a hypersialylated immunoglobulin designed as a high potency alternative for intravenous immunoglobulin (IVIg)
- The Company’s multi-part Phase 1/2 clinical trial in idiopathic thrombocytopenic purpura (ITP) has completed Part A and is progressing through Part B, which is evaluating M254 in a single ascending dose (SAD) cohort of ITP patients. Parts C and D include a randomized cross-over study comparing M254 to IVIg and a multiple ascending dose (MAD) study of M254, respectively. Enrollment is ongoing and the Company expects to report preliminary data from this study in the first half of 2020.
M230 (CSL730): a recombinant Fc multimer being developed in collaboration with CSL
- A Phase 1 clinical trial to evaluate the safety and tolerability of M230 in healthy volunteers is ongoing and Momenta’s partner, CSL, looks forward to introducing a subcutaneous formulation into the phase 1 program. We expect to have data regarding this formulation in the next calendar year.
Glatopa® 20 mg and 40 mg:
- In the third quarter of 2019, Momenta recorded
$5.6 millionin product revenue from Sandoz’s sales of Glatopa products.
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.
September 2019, the Company announced the appointment of Donna Grogan, M.D. to its Board of Directors.
Third Quarter 2019 Financial Results
In the third quarter of 2019, the Company recorded
Research and development revenue for the third quarter of 2019 was
Total revenue for the third quarter of 2019 was
Research and development expenses for the third quarter of 2019 were
General and administrative expenses for the third quarter of 2019 were
Total GAAP operating expenses were
Net Income (Loss): The Company reported a net loss of
Liquidity: At September 30, 2019, Momenta had
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 is providing 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 3067995.
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; 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 Quarterly Report on Form 10-Q for the quarter ended
|INVESTOR CONTACT:||MEDIA CONTACT:|
|Patty Eisenhaur||Karen Sharma|
|Momenta Pharmaceuticals||MacDougall Biomedical Communications|
MOMENTA PHARMACEUTICALS, INC.
Unaudited Condensed Consolidated Balance Sheets
|Cash, cash equivalents and marketable securities||$||325,862||$||449,411|
|Liabilities and Stockholders’ Equity|
|Deferred revenue, net of current portion||1,183||1,774|
|Other long-term liabilities||80,080||17,270|
|Total liabilities and stockholders’ equity||$||397,768||$||531,563|
MOMENTA PHARMACEUTICALS, INC.
Unaudited Condensed Statements of Operations and Comprehensive Loss
(in thousands, except per share amounts)
|Three Months Ended
|Nine Months Ended
|Research and development revenue||840||1,263||4,450||3,846|
|Total collaboration revenue||6,391||14,884||15,686||32,767|
|Research and development||46,105||30,727||106,208||95,309|
|General and administrative||20,081||20,437||90,896||63,580|
|Other operating expense||—||—||42,936||30,000|
|Gain on lease modification||(13,720||)||—||(13,720||)||—|
|Total operating expenses||52,485||66,699||226,497||204,424|
|Loss from operations||(46,094||)||(51,815||)||(210,811||)||(171,657||)|
|Other income, net||1,551||1,515||7,456||3,841|
|Net loss per share:|
|Basic and diluted||$||(0.45||)||$||(0.65||)||$||(2.06||)||$||(2.20||)|
|Shares used in calculating net loss per share|
|Basic and diluted||98,709||77,229||98,501||76,415|
MOMENTA PHARMACEUTICALS, INC.
Reconciliation of GAAP Results to Non-GAAP Financial Measures
A reconciliation of historical GAAP operating expenses to Non-GAAP operating expenses is as follows:
|Three Months Ended
|Nine Months Ended
|GAAP operating expenses||$||52,485||$||66,699||$||226,497||$||204,424|
|Non-cash stock compensation expense||(6,689||)||(10,126||)||(13,825||)||(20,172||)|
|Collaboration expenses that are recorded as revenue and are reimbursable by collaborators||(119||)||(632||)||(882||)||(1,943||)|
|Non-GAAP operating expenses||$||45,658||$||55,941||$||211,613||$||182,309|
Source: Momenta Pharmaceuticals, Inc.