Momenta Pharmaceuticals Reports Second Quarter 2019 Financial and Operating Results
— Launches adaptive Phase 2/3 study of nipocalimab (M281) in Warm Autoimmune Hemolytic Anemia (wAIHA), the Company’s third study of its FcRn inhibitor; top-line data expected by end of 2021 —
— Company receives FDA Fast Track Designation for nipocalimab in wAIHA and HDFN —
“At Momenta, we are focused on leveraging our team’s expertise in the engineering of biologics and our deep understanding of immune biology to develop treatments for rare immune-mediated disorders,” said
“In connection with the recent Amphastar settlement and our contractual obligations to GSK, we incurred one-time operating expenses in the second quarter. Importantly, as these charges are also connected with long-term cost-savings, these charges do not impact our forecasted cash runway and we continue to expect our available funds will take us beyond our clinical read outs in 2020,” said
Second 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)
- The Company recently announced that it commenced an adaptive Phase 2/3 clinical study of nipocalimab in Warm Autoimmune Hemolytic Anemia (wAIHA). This followed acceptance of its Investigational New Drug (IND) application and the granting of Fast Track designation in this indication by the
U.S. Food and Drug Administration( FDA). Clinical sites are currently being activated and patient recruitment is underway. The Company expects to report top-line data from this study by the end of 2021.
- Vivacity-MG, the Company’s Phase 2 clinical study of nipocalimab in generalized myasthenia gravis (gMG), continues to open sites and enroll patients and the Company expects to report top-line data 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), continues to open sites and enroll patients and the Company expects to report top-line data in 2021. Nipocalimab has been granted Fast Track designation by the
FDAfor this indication.
- In the second quarter 2019, the Company completed an infusion study of nipocalimab, supporting improved infusion rates versus the current two-hour protocol, and confirmed the safety profile observed in the Phase 1 study. Infusion rates as low as 7.5 minutes for 30 mg/kg dose or 15 minutes for 60 mg/kg dose were well tolerated.
M254 (hsIgG): a hypersialylated immunoglobulin designed as a high potency alternative for intravenous immunoglobulin (IVIg)
- The Company’s Phase 1/2 clinical trial in idiopathic thrombocytopenic purpura (ITP) is progressing. The multi-part study has completed Part A, which evaluated M254 in a single ascending dose (SAD) cohort of healthy volunteers, and has advanced into Part B, which will evaluate M254 in a 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 for this trial 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 is exploring the use of a subcutaneous formulation, which is expected to extend Phase 1.
Glatopa® 20 mg and 40 mg:
- In the second quarter of 2019, Momenta recorded
$3.3 millionin product revenue from Sandoz’s sales of Glatopa products.
M923: a fully-owned proposed biosimilar to HUMIRA® (adalimumab)
- Today, Momenta announced the Company will cease active development of M923 at this time, due to changes in the market opportunity associated with Humira patent litigation settlements.
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.
June 2019, Momenta and Sandozreached a settlement agreement with Amphastar, resolving all pending litigation between the parties related to Enoxaparin sodium injection, an FDA-approved, substitutable generic LOVENOX, which Momenta developed in collaboration with Sandoz. As a result of the settlement, the Company paid Amphastar $21.0 millionat the end of the second quarter and expects to recover its $36.1 millionbond in the third quarter 2019.
July 2019, Momenta entered into an amendment to its office and laboratory space lease at 320 Bent Streetin Cambridge, Massachusetts, reducing the Company’s footprint at the location. The Company will incur a $3.1 milliontermination fee in the third quarter 2019 and will reduce its remaining lease payments through February 2027by approximately $62.7 million.
Second Quarter 2019 Financial Results
In the second quarter of 2019, the Company recorded
Research and development revenue for the second quarter of 2019 was
Total revenue for the second quarter of 2019 was
Research and development expenses for the second quarter of 2019 were
General and administrative expenses for the second quarter of 2019 were
Other operating expenses in the second quarter of 2019 included a
Total GAAP operating expenses were
Net Income (Loss): The Company reported a net loss of
Liquidity: At June 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 expense, less stock-based compensation expense, restructuring expense and collaborative reimbursement revenue. Momenta is providing its average 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 3896218.
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 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||$||344,074||$||449,411|
|Liabilities and Stockholders’ Equity|
|Deferred revenue, net of current portion||1,112||1,774|
|Other long-term liabilities||124,100||17,270|
|Total liabilities and stockholders’ equity||$||479,686||$||531,563|
MOMENTA PHARMACEUTICALS, INC.
Unaudited Condensed Statements of Operations and Comprehensive Loss
(in thousands, except per share amounts)
|Three Months Ended
|Six Months Ended
|Research and development revenue||1,849||1,252||3,610||2,583|
|Total collaboration revenue||5,182||13,031||9,295||17,883|
|Research and development||32,131||31,340||60,103||64,582|
|General and administrative||46,609||22,531||70,815||43,143|
|Other operating expense||42,936||30,000||42,936||30,000|
|Total operating expenses||121,808||83,871||174,012||137,725|
|Loss from operations||(116,626||)||(70,840||)||(164,717||)||(119,842||)|
|Other income, net||2,657||955||5,905||2,326|
|Net loss per share:|
|Basic and diluted||$||(1.16||)||$||(0.91||)||$||(1.61||)||$||(1.55||)|
|Shares used in calculating net loss per share|
|Basic and diluted||98,595||76,543||98,396||76,002|
MOMENTA PHARMACEUTICALS, INC.
Reconciliation of GAAP Results to Non-GAAP Financial Measures
A reconciliation of historical GAAP operating expenses to Non-GAAP operating expenses is as follows:
|Three Months Ended
|Six Months Ended
|GAAP operating expenses||$||121,808||$||83,871||$||174,012||$||137,725|
|Non-cash stock compensation expense||(3,662||)||(5,172||)||(7,136||)||(10,046||)|
|Collaboration expenses that are recorded as revenue and are reimbursable by collaborators||(343||)||(735||)||(763||)||(1,318||)|
|Non-GAAP operating expenses||$||117,671||$||77,964||$||165,955||$||126,361|
Source: Momenta Pharmaceuticals, Inc.