MNTA Momenta Pharmaceuticals Inc.

32.99
+0.72  (+2%)
Previous Close 32.27
Open 32.66
52 Week Low 9.51
52 Week High 39.88
Market Cap $3,880,924,004
Shares 117,639,406
Float 70,144,207
Enterprise Value $3,371,422,631
Volume 385,374
Av. Daily Volume 1,205,104
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Upcoming Catalysts

Drug Stage Catalyst Date
M254
Immune Thrombocytopenic Purpura (ITP)
Phase 1/2
Phase 1/2
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Nipocalimab (M281)
Warm Autoimmune Hemolytic Anemia (wAIHA)
Phase 2/3
Phase 2/3
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Drug Pipeline

Drug Stage Notes
M230 (CSL730)
Healthy volunteers
Phase 1
Phase 1
Phase 1 initiation 2020.
Nipocalimab (M281)
generalized myasthenia gravis (gMG)
Phase 2
Phase 2
Phase 2 trial met primary endpoint - June 15, 2020.
Nipocalimab (M281)
hemolytic disease of the fetus and newborn (HDFN)
Phase 2
Phase 2
Phase 2 trial ongoing.
M254
Chronic inflammatory demyelinating polyneuropathy (CIDP)
Phase 2
Phase 2
Phase 2 trial to be initiated in 2021.
Necuparanib (MOM-M402-103)
Advanced metastatic pancreatic cancer
Phase 1/2
Phase 1/2
Phase 2 development discontinued due to poor efficacy shown
Generic Copaxone
Multiple sclerosis
Approved
Approved
Filed 2007. Approved April 16 2015.

Latest News


  1. - Nipocalimab induced a rapid and durable response in the myasthenia gravis activities of daily living score (MG-ADL) at all doses -

    - Nipocalimab was well tolerated, with no adverse events leading to discontinuation -       

                – Company to host a conference call today at 8:30 a.m. EST –

    CAMBRIDGE, Mass., June 15, 2020 (GLOBE NEWSWIRE) --  Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today announced positive topline data from an interim analysis of…

    - Trial met primary endpoint with a strong relationship between Immunoglobulin G (IgG) reduction and MG-ADL clinical benefit (p<0.0001) -      

    - Nipocalimab induced a rapid and durable response in the myasthenia gravis activities of daily living score (MG-ADL) at all doses -

    - Nipocalimab was well tolerated, with no adverse events leading to discontinuation -       

                – Company to host a conference call today at 8:30 a.m. EST –

    CAMBRIDGE, Mass., June 15, 2020 (GLOBE NEWSWIRE) --  Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today announced positive topline data from an interim analysis of its Phase 2 Vivacity-MG study of nipocalimab (M281) in generalized myasthenia gravis (gMG). All four treatment arms showed efficacy in the myasthenia gravis activities of daily living (MG-ADL) score, the primary endpoint. Additionally, all dosing arms showed strong safety and tolerability profiles.

    "We are thrilled with the success of nipocalimab's proof of concept trial in MG. We met our primary endpoint in this trial, demonstrating rapid and durable responses in all 4 dosing arms and a significant correlation between IgG reduction and efficacy," said Craig Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "The data we are sharing today continues to build the evidence that nipocalimab has the potential to be a best-in-class agent in terms of efficacy, safety and dosing. Thank you to the patients, families and researchers who made this study possible, especially during the COVID-19 pandemic. We look forward to sharing the full data set later this year at a medical conference and discussing our phase 3 plans as we work to bring forward what we hope will be the best in class FcRn agent."

    Study Design

    The Vivacity-MG study, initiated April 2019, is a Phase 2, multicenter, randomized double-blind, placebo-controlled study evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of nipocalimab in 68 patients with moderate-to-severe generalized MG (gMG). The 8-week treatment period included four active arms (5 mg/kg every 4 weeks, 30 mg/kg every 4 weeks, 60 mg/kg every two weeks, and a 60 mg/kg single dose) and one placebo arm. The primary endpoint of the study was to reach statistically significant change from the baseline score of the myasthenia gravis Activities of Daily Living (MG-ADL) score.

    Key Study Results

    • 52% of patients who received nipocalimab had rapid, significant and durable reductions in MG-ADL scores (at least a 2-point reduction from baseline for at least 4 consecutive weeks) across all four dosing arms, versus 15% of placebo treated patients (p=0.017)
    • A statistically significant relationship was observed between IgG reduction and clinical benefit for patients taking nipocalimab (p<0.0001)
    • Patients across all four nipocalimab dosing arms showed rapid reductions in MG-ADL scores, with clinically meaningful changes from baseline within two weeks
    • Nipocalimab (M281) was well tolerated, safe and efficacious in gMG patients. There were no severe or serious nipocalimab-related adverse events and most adverse events were characterized as mild
    • The study findings support continued clinical development in gMG and subcutaneous formulation dose selection.

    The study is expected to be completed in the third quarter of 2020. The Company plans to present the 16-week data with analysis of secondary endpoints and importantly, duration of efficacy, in the fourth quarter 2020.

    "We're pleased to unveil positive topline interim results from our Phase 2 study in gMG which demonstrates our deep understanding of the clinical relationship between IgG reduction and efficacy of nipocalimab in alleviating the debilitating symptoms of gMG," said Santiago Arroyo, M.D., Ph.D., Chief Medical Officer of Momenta Pharmaceuticals.

    "The knowledge we have gained from this multi-arm dosing study serves as a roadmap to design a Phase 3 study focused on dosing precision and flexibility, and ultimately for physicians to better understand the onset of action and duration of effect for their gMG patients."

    "For patients with myasthenia gravis, current treatment options include medications such as acetylcholinesterase inhibitors, corticosteroids and immunosuppressants which may provide improvement in muscle strength; however, many patients fail to respond, have substantial side effects or have uncontrolled disease symptoms that limit their daily function and quality of life. The promise of nipocalimab to reduce pathogenic autoantibodies in a dose dependent manner, brings me great hope in providing these patients with a new treatment option," said Jeffrey T Guptill, M.D., Principal Investigator. "The correlation between IgG reduction and symptom control across all doses in the nipocalimab trial may provide physicians the ability to optimally adjust patient dosing," he added.

    Based on the data, the Company has begun preparations to conduct end of Phase 2 meetings with regulatory agencies before the end of 2020.

    Management will host a conference call today at 8:30 a.m. ET to discuss these results. To access the call, please dial (833) 714-0880 (domestic) or +1 (778) 560-2636 (international) prior to the scheduled conference call time and provide the conference ID 7997563. A live webcast of the call will be available on the "Investors" section of the company's website, www.momentapharma.com. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call. 

    About Generalized Myasthenia Gravis (gMG)

    Myasthenia gravis (MG) is a chronic autoimmune neuromuscular disease that affects skeletal muscles responsible for eye movements, breathing, and body motion, causing muscle weakness and fatigue. Myasthenia gravis can be restricted to eye muscles or may affect other muscle besides eye muscles (generalized myasthenia gravis). In gMG, the immune system mistakenly attacks muscle receptors by producing anti-receptor antibodies (most commonly anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibodies) that can block or destroy these muscle receptors, preventing signals from transferring from nerves to muscles. Over time, this may lead to symptoms such as limb weakness, drooping eyelids, double vision, as well as causing difficulties with chewing, swallowing, speech, and breathing. Although gMG may be managed with current therapies, research is needed to develop new treatments for those who may not respond well enough to or tolerate current therapies. Additional information about MG can be found at iMaGineMyMG.com.

    Nipocalimab (M281) Overview

    Using proprietary antibody engineering technology, Momenta has developed nipocalimab (M281), a high affinity, fully human, aglycosylated, effectorless IgG1 anti-FcRn monoclonal antibody.

    In patients with gMG, nipocalimab is expected to improve nerve-to-muscle signals and muscle function, thus alleviating the clinical signs and symptoms of gMG.

    Nipocalimab is also being evaluated in two ongoing clinical trials: the Energy Study and Unity. The Energy Study is the Company's adaptive Phase 2/3 clinical study of nipocalimab in warm autoimmune hemolytic anemia (wAIHA). The Company is activating clinical sites globally and expects to reinitiate patient enrollment in the fourth quarter 2020. Nipocalimab has been granted Fast Track and Orphan Drug designation by the FDA in this indication. Unity, the Company's global multi-center Phase 2 clinical study of nipocalimab in hemolytic disease of the fetus and newborn (HDFN), is ongoing and actively enrolling patients. Additional clinical trial information can be found here and patients and families can find more information at www.momentapharma.com.

    About Momenta

    Momenta Pharmaceuticals is a biotechnology company with a validated innovative scientific platform focused on discovering and developing novel therapeutics to treat rare, immune-mediated diseases and advancing its late stage biosimilar portfolio. The company is headquartered in Cambridge, MA.

    To learn more about Momenta, please visit www.momentapharma.com, which does not form a part of this press release.

    Momenta's logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.

    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 design, timing, enrollment, strategy and goals of clinical trials and the availability, timing and announcement of data and results; the use, efficacy, safety, tolerability, potency, convenience and commercial potential of our product candidates, including their potential as best-in-class agents; and the timing of planned regulatory submissions and meetings. Forward-looking statements may be identified by words such as "looking forward to", "may", "possibly", "promise", "hope", "believe," "continue," "plan to," "potential," "will," "expect," 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 important factors, including the final and quality controlled verification of interim data and related analyses; impact of the COVID-19 pandemic on the timing, enrollment or results of our clinical trials; unpredictable nature of early stage development efforts for our product candidates; safety, efficacy or tolerability problems with our product candidates; unexpected adverse clinical trial results; and those referred to under the section "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. The Company is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    INVESTOR CONTACT:                                        

    Patty Eisenhaur                                          

    Momenta Pharmaceuticals                                   

    1-617-395-5189                                           

    MEDIA CONTACT:



    Karen Sharma

    MacDougall

    1-781-235-3060

                                                             

    Primary Logo

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  2. -- Top-line interim data from nipocalimab Vivacity-MG study expected by Q3 2020 --

    -- Full data from Part B of Phase 1/2 study of M254 in ITP expected in Q3 2020 --

    -- Initiated IND-enabling studies for M267, a SIFbody candidate targeting CD38 --

    CAMBRIDGE, Mass., May 07, 2020 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today reported its financial results for the first quarter ended March 31, 2020.

    "Despite the turbulence imposed by the COVID-19 pandemic, Momenta has remained focused on advancing our development pipeline for rare, immune-mediated diseases," said Craig A. Wheeler, President…

    -- Top-line interim data from nipocalimab Vivacity-MG study expected by Q3 2020 --

    -- Full data from Part B of Phase 1/2 study of M254 in ITP expected in Q3 2020 --

    -- Initiated IND-enabling studies for M267, a SIFbody candidate targeting CD38 --

    CAMBRIDGE, Mass., May 07, 2020 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today reported its financial results for the first quarter ended March 31, 2020.

    "Despite the turbulence imposed by the COVID-19 pandemic, Momenta has remained focused on advancing our development pipeline for rare, immune-mediated diseases," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "We are targeting key readouts from our lead programs by the end of the third quarter. These readouts will include interim proof-of-concept data from nipocalimab in MG and data from Part B of our Phase 1/2 study of M254 in ITP. We expect data from both programs will further demonstrate the potential of these programs, each with franchise opportunities across a range of large market auto- and alloimmune diseases. Finally, we remain in a strong corporate position, with cash to fund operations through at least the third quarter 2021, as we continue to leverage our platform for growth."

    First Quarter 2020 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)

    • We announced in February that Vivacity-MG, the Company's Phase 2 clinical study of nipocalimab in generalized myasthenia gravis (gMG), achieved its target enrollment. Momenta remains on track to report top-line interim data from this study by the 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 enroll patients at sites where they can be safely accommodated. 
    • Momenta continues to activate sites globally for its Energy Study, the Company's adaptive Phase 2/3 clinical study of nipocalimab in warm autoimmune hemolytic anemia (wAIHA), however it has temporarily suspended patient enrollment due to the COVID-19 pandemic.

    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) is progressing through Part B, which is evaluating M254 in a single ascending dose (SAD) cohort of ITP patients, followed by 1,000mg/kg of IVIg. Enrollment is ongoing, however it has slowed due to the COVID-19 pandemic. The Company plans to complete and report data from Part B in the third quarter of 2020 and expects to initiate Part C of the study in the fourth quarter of 2020.
    • The Company's planned Phase 2 study of M254 in chronic inflammatory demyelinating polyneuropathy (CIDP) is expected to initiate in 2021, following completion of Parts C and D from its ongoing Phase 1/2 trial of M254 in ITP.

    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. Momenta's partner, CSL, plans to introduce a subcutaneous formulation into the Phase 1 program in 2020.

    Momenta's SIFbody platform combines multiple Fc's with antibody Fabs to optimally activate Fc effector function, and to effectively deplete target cells.

    • The Company has initiated IND-enabling studies for M267, a SIFbody candidate targeting CD38. Pre-clinical data suggest this candidate has the potential to be a best-in-class therapeutic to target CD38-expressing cells, which are prevalent in plasmacyte-mediated diseases such as multiple myeloma, AL amyloidosis and other rare, autoantibody-mediated diseases.

    Legacy Products:

    GLATOPA® 20 mg and 40 mg: U.S. Food and Drug Administration (FDA) approved generic versions of COPAXONE 20 mg and 40 mg, developed and commercialized in collaboration with Sandoz

    • In the first quarter of 2020, Momenta recorded $8.7 million in 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. Mylan expects to target U.S. submission in 2021, while monitoring and navigating potential COVID-19 issues.

    Corporate:

    • In April 2020, Momenta provided an update on clinical trial activities and business operations amid the COVID-19 pandemic, including measures implemented to protect the health and safety of its personnel, as well as patients and healthcare professionals involved with its clinical studies; to ensure its clinical studies were able to continue unimpeded for patients already enrolled; and to preserve the integrity of its clinical data, in line with updated guidance from the FDA. These business continuity measures currently remain in place, as the Company continues to closely monitor the situation and guidance from public health authorities. Momenta expects to resume activities for affected studies when conditions permit.

    First Quarter 2020 Financial Results

    Revenue:

    In the first quarter of 2020, the Company recorded $8.7 million in product revenue from Sandoz's sales of GLATOPA, compared to $2.4 million for the same period in 2019. The increase in product revenue from the prior year period was primarily due to higher net sales of GLATOPA, driven by volume increases.

    Research and development revenue for the first quarter of 2020 was $0.2 million, compared to $1.8 million for the same period in 2019. The decrease in research and development revenue of $1.6 million, or 89%, was primarily due to lower reimbursement revenue for GLATOPA expenses and lower revenue recognized from Mylan's upfront payment associated with the biosimilar collaboration.

    Total revenue for the first quarter of 2020 was $8.9 million compared to $4.1 million for the same period in 2019.

    Operating Expenses:

    Research and development expenses for the first quarter of 2020 were $34.2 million, compared to $28.0 million for the same period in 2019. The increase of $6.2 million, or 22%, was primarily due to an increase in manufacturing and clinical trial costs for nipocalimab and M254 and increased spending on M710, offset in part by lower lease costs.

    General and administrative expenses for the first quarter of 2020 were $14.6 million, compared with $24.2 million for the same period in 2019. The decrease of $9.6 million, or 40%, was primarily due to lower depreciation and rent costs due to the modification of the Bent St. lease and lower legal costs.

    Total GAAP operating expenses were $49.6 million in the first quarter of 2020. First quarter 2020 non-GAAP operating expense was $44.7 million. Non-GAAP operating expense is total operating expenses, less stock-based compensation expense, restructuring expense and collaborative reimbursement revenue. See "Non-GAAP Financial Information and Other Disclosures" and the table below entitled "Reconciliation of GAAP Results to Non-GAAP Financial Measures" for a reconciliation of GAAP operating expense to non-GAAP operating expense.

    Net Loss:

    The Company reported a net loss of $39.6 million, or $0.34 per share for the first quarter of 2020 compared to a net loss of $44.8 million, or $0.46 per share for the same period in 2019.

    Liquidity:

    At March 31, 2020, Momenta had $487.9 million in cash, cash equivalents, and marketable securities. This compares to $545.1 million at December 31, 2019 in cash, cash equivalents, and marketable securities.

    2020 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, less stock-based compensation expense, restructuring expense and collaborative reimbursement revenues. Due to lower clinical trial enrollment trends as a result of the COVID-19 pandemic, Momenta anticipates its full-year non-GAAP operating expenses will be lower than $220 - $240 million, as previously guided for 2020. The Company anticipates providing an update on expected non-GAAP operating expense for 2020 as part of its second quarter 2020 financial results.

    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 does not expect restructuring expense and collaboration reimbursement revenue to be material.

    Conference Call Information

    Management will host a conference call and webcast today at 8:30 am ET to discuss these results and provide an update on the Company. A live webcast of the conference call may be accessed on the "Investors" section of the Company's website, www.momentapharma.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call.

    To access the call, you may also dial (866) 209-9686 (domestic) or (825) 312-2288 (international) prior to the scheduled conference call time and provide the access code 9178486.

    About Momenta

    Momenta Pharmaceuticals is a biotechnology company with a validated innovative scientific platform focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases and advancing its late stage biosimilars and is headquartered in Cambridge, MA.

    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 Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.

    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; product development strategies, goals and timelines; the Company's ability to meet its development and strategic goals; market potential and revenue of our products and product candidates; design, timing, enrollment and goals of clinical trials and the availability, timing and announcement of data and results; the use, efficacy, safety, dosing, potency, tolerability, convenience and commercial potential of our product candidates, including their potential as best-in-class agents; reconciling information; non-GAAP operating expense guidance; and anticipated restructuring expenses 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 the risk of the impact of the COVID-19 pandemic on the timing, enrollment or results of our clinical trials, operating expenses, business and supply of manufactured drug materials and those referred to under the section "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. The Company is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    INVESTOR CONTACT: MEDIA CONTACT:
    Patty Eisenhaur Karen Sharma
    Momenta Pharmaceuticals MacDougall Biomedical Communications
    1-617-395-5189 1-781-235-3060


    MOMENTA PHARMACEUTICALS, INC.

    Unaudited Condensed Consolidated Balance Sheets

    (in thousands)

      March 31, 2020   December 31, 2019
    Assets      
    Cash, cash equivalents and marketable securities $ 487,872     $ 545,110  
    Collaboration receivable 16,592     8,013  
    Restricted cash 1,849     1,849  
    Other assets 62,433     63,393  
    Total assets $ 568,746     $ 618,365  
           
    Liabilities and Stockholders' Equity      
    Current liabilities $ 83,158     $ 106,104  
    Deferred revenue, net of current portion 895     940  
    Other long-term liabilities 56,500     56,861  
    Stockholders' equity 428,193     454,460  
    Total liabilities and stockholders' equity $ 568,746     $ 618,365  



    MOMENTA PHARMACEUTICALS, INC.

    Unaudited Condensed Statements of Operations and Comprehensive Loss

    (in thousands, except per share amounts)

      Three Months Ended March 31,
      2020   2019
    Collaboration revenues:      
    Product revenue $ 8,692     $ 2,352  
    Research and development revenue 197     1,761  
    Total collaboration revenue 8,889     4,113  
           
    Operating expenses:      
    Research and development 34,207     27,972  
    General and administrative 14,564     24,206  
    Other operating expense 786      
    Restructuring     26  
    Total operating expenses 49,557     52,204  
           
    Loss from operations (40,668 )   (48,091 )
           
    Other income, net 1,113     3,248  
    Net loss $ (39,555 )   $ (44,843 )
           
    Net loss per share:      
    Basic and diluted $ (0.34 )   $ (0.46 )
           
    Shares used in calculating net loss per share      
    Basic and diluted 117,125     98,195  
           
    Comprehensive loss $ (39,970 )   $ (44,501 )



    MOMENTA PHARMACEUTICALS, INC.

    Reconciliation of GAAP Results to Non-GAAP Financial Measures

    (in thousands)

    (unaudited)

    A reconciliation of historical GAAP operating expenses to Non-GAAP operating expenses is as follows:

      Three Months Ended March 31,
      2020   2019
           
    GAAP operating expenses $ 49,557     $ 52,204  
    Adjustments:      
    Restructuring     (26 )
    Non-cash stock compensation expense (4,823 )   (3,474 )
    Collaboration expenses that are recorded as revenue and are reimbursable by collaborators (5 )   (420 )
    Non-GAAP operating expenses $ 44,729     $ 48,284  

     

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  3. CAMBRIDGE, Mass., April 23, 2020 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today announced that it will release its financial results for the first quarter ended March 31, 2020 before the U.S. financial markets open on Thursday, May 7, 2020.  

    Management will host a conference call on May 7, 2020 at 8:30 a.m. ET to discuss these results and provide an update on the company. To access the call, please dial (866) 209-9686 (domestic) or (825) 312-2288 (international) prior to the scheduled conference call time and provide the access code 9178486. A live webcast of the call will be available on…

    CAMBRIDGE, Mass., April 23, 2020 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today announced that it will release its financial results for the first quarter ended March 31, 2020 before the U.S. financial markets open on Thursday, May 7, 2020.  

    Management will host a conference call on May 7, 2020 at 8:30 a.m. ET to discuss these results and provide an update on the company. To access the call, please dial (866) 209-9686 (domestic) or (825) 312-2288 (international) prior to the scheduled conference call time and provide the access code 9178486. A live webcast of the call will be available on the "Investors" section of the company's website, www.momentapharma.com. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call. 

    About Momenta

    Momenta Pharmaceuticals is a biotechnology company with a validated innovative scientific platform focused on discovering and developing novel therapeutics to treat rare, immune-mediated diseases and advancing its late stage biosimilar portfolio. The company is headquartered in Cambridge, MA.

    To learn more about Momenta, please visit www.momentapharma.com, which does not form a part of this press release.

    Momenta's logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.

    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 use, design, timing, strategy and goals of clinical trials; the efficacy, safety, tolerability, potency, convenience and commercial potential of our product candidates, and the timing of the announcement of its financial results for the quarter ended March 31, 2020. Forward-looking statements may be identified by words such as "believe," "continue," "plan to," "potential," "will," 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 important factors, including the risk of the unpredictable nature of early stage development efforts for our product candidates; safety, efficacy or tolerability problems with our product candidates; unexpected adverse clinical trial results; and those referred to under the section "Risk Factors" in the Company's Annual Report on Form 10-K for the year and quarter ended December 31, 2019 filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. The Company is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    INVESTOR CONTACT:                              
    Patty Eisenhaur                                             
    Momenta Pharmaceuticals                           
    1-617-395-5189                                             

    Primary Logo

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  4. CAMBRIDGE, Mass., April 02, 2020 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today provided an update on the Company's clinical trial activities and business operations in light of  the COVID-19 pandemic.

    "The COVID-19 pandemic has greatly impacted the global healthcare system. During these challenging times, our utmost priority is the health and safety of patients in our clinical studies and the healthcare professionals who care for them, as well as our team. To that end, we have implemented measures to protect their well-being while ensuring our ability to maintain the continuity of our business…

    CAMBRIDGE, Mass., April 02, 2020 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today provided an update on the Company's clinical trial activities and business operations in light of  the COVID-19 pandemic.

    "The COVID-19 pandemic has greatly impacted the global healthcare system. During these challenging times, our utmost priority is the health and safety of patients in our clinical studies and the healthcare professionals who care for them, as well as our team. To that end, we have implemented measures to protect their well-being while ensuring our ability to maintain the continuity of our business," said Craig Wheeler, President and Chief Executive Officer at Momenta Pharmaceuticals. "At this time, we are in active communication with clinical sites to be sure patients enrolled in our studies have uninterrupted access to our investigational drugs. However, in light of COVID-19, its global impact on healthcare systems and patients and healthcare professionals involved in clinical trials, we are suspending enrollment in certain ongoing clinical trials and delaying the launch of planned studies until conditions permit. We are closely monitoring this situation as it continues to evolve and will provide additional updates, as necessary, in our first quarter earnings release."

    Update on Clinical Trial Activities:

    Momenta remains committed to its development programs, but recognizes the impact and risks imposed by COVID-19 on the global healthcare system. The Company is making all efforts to allow patients currently enrolled in its clinical studies to continue unimpeded and is in close contact with clinical sites to ensure patients have access to our investigational drugs. Momenta has also implemented additional measures to protect the health and safety of patients and healthcare professionals involved with its clinical studies, and to preserve the integrity of its clinical data.

    • Nipocalimab (M281): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb)
      • Vivacity-MG is the Company's Phase 2 clinical study of nipocalimab in generalized myasthenia gravis (gMG). As previously reported, this trial achieved target patient enrollment in February 2020. The Company currently remains on track to report topline data from this study in the 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 enroll patients at sites where they can be safely accommodated. At this time, based on the life-threatening nature of HDFN, the Company does not intend to pause enrollment of the study but anticipates a slower pace of enrollment due to the overall global impact of COVID-19.
      • The Company's Energy Study, an adaptive Phase 2/3 clinical study of nipocalimab in warm autoimmune hemolytic anemia (wAIHA), has been activating sites globally. The Company will continue to activate sites but has temporarily suspended patient enrollment.
         
    • M254 (hsIgG): a hypersialylated immunoglobulin designed as a high potency alternative for intravenous immunoglobulin (IVIg)
      • M254 is currently being evaluated in Momenta's multi-part Phase 1/2 study in idiopathic thrombocytopenic purpura (ITP). Momenta continues to enroll lower dose cohorts in Part B of the ongoing trial, however most of the sites have suspended enrollment due to the COVID-19 pandemic. As a result and in anticipation of slower enrollment, the Company may not be able to report interim data as planned for the second quarter of 2020. The ITP study Parts C and D, which are being evaluated in the context of emerging Part B data, will be delayed until Part B is complete and depending on then-prevailing conditions for clinical trials.
      • The Company also expects that its planned Phase 2 study of M254 in chronic inflammatory demyelinating polyneuropathy (CIDP) will commence in 2021.

    Momenta is closely monitoring the evolving situation and expects to resume patient enrollment and initiate delayed studies when conditions permit.

    Update on Business Operations:

    Momenta has implemented measures to mitigate the spread of COVID-19 and protect the health and safety of its personnel amid this pandemic. In line with guidance from the U.S. Centers for Disease Control and Prevention (CDC) and the state of Massachusetts, the Company's workforce is working remotely, and the Company has suspended all business travel.

    Momenta believes it has sufficient manufactured drug material to supply its ongoing clinical studies. At this time and subject to further COVID-19 implications, the Company does not anticipate any disruptions to its clinical supply.

    The Company will provide further business updates, including its 2020 operating expense guidance, with its first quarter 2020 financial results.

    About Momenta

    Momenta Pharmaceuticals is a biotechnology company with a validated innovative scientific platform focused on discovering and developing novel therapeutics to treat rare, immune-mediated diseases and advancing its late stage biosimilar portfolio. The company is headquartered in Cambridge, MA.

    To learn more about Momenta, please visit www.momentapharma.com, which does not form a part of this press release.

    Momenta's logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.

    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 use, design, timing, enrollment, strategy and goals of clinical trials and the availability, timing and announcement of data and results, ; the efficacy, safety, tolerability, potency, convenience and commercial potential of our product candidates and Momenta's expectations regarding the impact of the COVID-19 pandemic on its clinical trials, clinical supply and business operations. Forward-looking statements may be identified by words such as "anticipate" "believe," "continue," expect", "intend" "plan to," "potential," "will," 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 important factors, including the impact of the COVID-19 pandemic on the status, enrollment, timing and results of our clinical trials, the supply of our manufactured drug materials and the continuity of our business, the unpredictable nature of early stage development efforts for our product candidates; safety, efficacy or tolerability problems with our product candidates; unexpected adverse clinical trial results; and those referred to under the section "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. The Company is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    INVESTOR CONTACT:
    Patty Eisenhaur
    Momenta Pharmaceuticals
    1-617-395-5189

    MEDIA CONTACT:
    Karen Sharma
    MacDougall
    781-235-3060

    Primary Logo

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  5. -- Reported favorable interim data from Phase 1/2 study of M254 in ITP, supporting expansion of Part B; expect to report updated data in Q2 2020 and launch additional Phase 2 study in CIDP in Q4 2020 --

    -- Target enrollment completed in nipocalimab Phase 2 Vivacity-MG study; top-line proof-of-concept results expected in Q3 2020 --

    -- Expanded pipeline with nomination of M267, a new SIFbody development candidate targeting CD38; plan to initiate IND-enabling studies in 2020 --

    -- Ended 2019 with a cash position of $545.1 million --

    CAMBRIDGE, Mass., Feb. 26, 2020 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated…

    -- Reported favorable interim data from Phase 1/2 study of M254 in ITP, supporting expansion of Part B; expect to report updated data in Q2 2020 and launch additional Phase 2 study in CIDP in Q4 2020 --

    -- Target enrollment completed in nipocalimab Phase 2 Vivacity-MG study; top-line proof-of-concept results expected in Q3 2020 --

    -- Expanded pipeline with nomination of M267, a new SIFbody development candidate targeting CD38; plan to initiate IND-enabling studies in 2020 --

    -- Ended 2019 with a cash position of $545.1 million --

    CAMBRIDGE, Mass., Feb. 26, 2020 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today reported its financial results for the fourth quarter and full year ended December 31, 2019.

    "2019 was a transformative year for Momenta as the power of our pipeline began to show itself," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "Thanks to our talented research team, we are also expanding our pipeline, starting with the nomination of M267, our new SIFbody development candidate earlier this year."

    Fourth Quarter 2019 Highlights, Recent Events and Anticipated Upcoming Milestones

    Novel Therapeutics Pipeline:

    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) is progressing through Part B, which is evaluating M254 compared to IVIg in a single ascending dose (SAD) cohort of ITP patients. In January 2020, Momenta announced interim results, featuring early favorable responses to M254 (5/6 patients on treatment exhibited platelet counts ≥ 50 x 109/L). Based on these data, the Company is expanding Part B to include at least one additional lower dose cohort and to augment the number of patients in existing cohorts. Enrollment for the study is ongoing, with additional data from Part B to be submitted for presentation at a medical conference in the second quarter of 2020.
    • The Company plans to launch a Phase 2 study of M254 in chronic inflammatory demyelinating polyneuropathy (CIDP) in the fourth quarter of 2020.

    Nipocalimab (M281): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb)

    • The Company has completed its target enrollment in Vivacity-MG, the Phase 2 clinical study of nipocalimab in generalized myasthenia gravis (gMG). The Company expects to report top-line data in the 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 enrolling well. The Company expects to report top-line data from this study in 2021.
    • Energy Study, the Company's adaptive Phase 2/3 clinical study of nipocalimab in warm autoimmune hemolytic anemia (wAIHA) is enrolling patients and the Company is activating clinical sites in both the United States and European Union. Top-line data are expected from this study around the end of 2021.

    M230 (CSL730): a recombinant Fc multimer being developed in collaboration with CSL

    • A Phase 1 clinical program to evaluate the safety and tolerability of M230 in healthy volunteers is continuing. Momenta's partner, CSL, plans to introduce a subcutaneous formulation into the Phase 1 program this year.

    Momenta's SIFbody platform combines multiple Fc's with antibody fabs to optimally activate Fc and complement effector function and effectively deplete target cells.

    • In January 2020, Momenta nominated M267, a SIFbody candidate targeting CD38, for clinical development. Pre-clinical data suggest this candidate has the potential to be a best-in-class therapeutic to target CD38 expressing cells, which are prevalent in plasmacyte-mediated diseases such as multiple myeloma, AL amyloidosis and rare, autoantibody-mediated diseases.
    • The Company plans to initiate IND-enabling studies for this candidate in 2020.

    Legacy Products:

    GLATOPA® 20 mg and 40 mg: FDA approved generic versions of COPAXONE 20 mg and 40 mg, developed and commercialized in collaboration with Sandoz

    • In the fourth quarter of 2019, Momenta recorded $7.9 million in 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. Mylan expects to target U.S. submission in 2021.

    Corporate:

    • In January 2020, Momenta announced the appointment of Young Kwon, Ph.D. as Chief Financial and Business Officer. Dr. Young previously served as Chief Business Officer at the Company.

    • In December 2019, the Company announced the appointment of Jane F. Barlow, M.D., M.P.H., M.B.A. to its Board of Directors.

    • In December 2019, Momenta announced the closing of a public offering of 16.7 million shares of its common stock at the price of $15.50 per share. Net proceeds from the offering were $244.2 million.

    • In December 2019, Momenta and Sandoz entered into a settlement agreement with The Hospital Authority of Metropolitan Government of Nashville and Davidson County, Tennessee, d/b/a Nashville General Hospital, or NGH, 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 agreed to pay an aggregate of $35.0 million as consideration for the release of all alleged claims.

    Fourth Quarter and Full Year 2019 Financial Results

    Revenue:

    In the fourth quarter of 2019, the Company recorded $7.9 million in product revenue from Sandoz's sales of GLATOPA, compared to $10.8 million for the same period in 2018. For the year ended December 31, 2019, the Company recorded $19.1 million in product revenue from Sandoz's sales of GLATOPA, compared to $39.7 million for the same period in 2018. The decrease in product revenue of $2.9 million, or 27%, from the fourth quarter of 2018 to the fourth quarter of 2019 was primarily due to lower net sales of GLATOPA driven by competition. The decrease in product revenue of $20.6 million, or 52%, from the year ended 2018 to the year ended 2019 was primarily due to lower net sales of GLATOPA driven by competition, a $1.5 million legal settlement payment to Teva Pharmaceuticals Industries Ltd. and related entities in the first quarter of 2019, representing Momenta's 50% share, and $1.7 million received by Momenta in the third quarter of 2018 for the Pfizer settlement.

    Research and development revenue for the fourth quarter of 2019 was $0.3 million compared to $32.1 million for the same quarter in 2018. For the year ended December 31, 2019, research and development revenue was $4.8 million compared to $35.9 million for the same period in 2018. The decrease in research and development revenue of $31.8 million, or 99.1%, and $31.1 million, or 87%, from the fourth quarter of 2018 to the fourth quarter of 2019, and from the year ended 2018 to the year ended 2019, respectively, was primarily due to $28.4 million of revenue recognized related to Mylan's upfront payment of $45.0 million during the fourth quarter of 2018 and lower reimbursement revenue for GLATOPA expenses in 2019.

    Total revenue for the fourth quarter of 2019 was $8.2 million, compared to $42.8 million for the same period in 2018. For the year ended December 31, 2019, total revenue was $23.9 million, compared to $75.6 million for the same period in 2018.

    Operating Expenses:

    Research and development expenses for the fourth quarter of 2019 were $38.3 million, compared to $28.7 million for the same period in 2018. The increase of $9.6 million, or 33%, was primarily due to an increase in manufacturing and clinical trial costs for nipocalimab and M254, offset in part by lower personnel costs following the Company's workforce reduction in the fourth quarter of 2018 and a reduction in lease costs. For the year ended December 31, 2019, research and development expenses were $144.5 million, compared to $124.0 million for the same period in 2018. The increase of $20.5 million, or 17%, was primarily due to an increase in manufacturing and clinical trial costs for nipocalimab and M254, offset partially by a decrease in our share of CSL collaboration costs, lower personnel costs following the Company's workforce reduction in the fourth quarter of 2018 and a reduction in lease costs.

    General and administrative expenses for the fourth quarter of 2019 were $58.9 million, compared with $21.5 million for the same period in 2018. The increase of $37.4 million, or 174%, was primarily due to $35.0 million related to a settlement agreement with Nashville General Hospital related to Enoxaparin Sodium Injection. For the year ended December 31, 2019, general and administrative expenses were $149.8 million, compared to $85.1 million for the same period in 2018. The increase of $64.7 million, or 76%, was primarily due to $35.0 million related to the settlement agreement with Nashville General Hospital, $21.0 million paid to Amphastar Pharmaceuticals in June 2019, reflecting the Company's portion of the required settlement payments related to Enoxaparin Sodium Injection, increased depreciation of $4.8 million associated with a change in the estimated useful life of certain leasehold improvements in the fourth quarter of 2018, increased share-based compensation expense of $4.1 million, driven primarily by expense recognized on performance-based restricted stock units in the fourth quarter of 2019, and increased consultant spend of $4.2 million. These increases were partially offset by decreased personnel costs, including salaries and share-related benefits, of $3.9 million due to the workforce reduction announced in October 2018.

    In July 2019, the Company entered into an amendment to its office and laboratory space lease at 320 Bent Street in Cambridge, Massachusetts, reducing the Company's footprint at this location. During the year ended December 31, 2019, the Company recognized a non-cash gain of $13.7 million, reflecting the reduction in the lease liability and the related right-of-use asset.

    Total GAAP operating expenses for the fourth quarter of 2019 were $95.5 million, compared to $52.5 million for the same period in 2018. For the year ended December 31, 2019, total GAAP operating expenses were $322.0 million, compared to $256.9 million for the same period in 2018.

    Fourth quarter non-GAAP operating expense was $86.9 million. Full year 2019 non-GAAP operating expense was $298.5 million. Non-GAAP operating expense is total operating expenses (which excludes collaboration expenses reimbursable by Mylan), less restructuring costs, stock-based compensation expense and collaborative reimbursement revenues. See "Non-GAAP Financial Information and Other Disclosures" and the table below entitled "Reconciliation of GAAP Results to Non-GAAP Financial Measures" for a reconciliation of GAAP operating expense to non-GAAP operating expense.

    Net Income (Loss):

    The Company reported a net loss of $86.7 million, or $0.85 per share for the fourth quarter of 2019, compared to a net loss of $8.2 million, or $0.10 per share for the same period in 2018. For the year ended December 31, 2019, the Company reported a net loss of $290.1 million, or $2.92 per share compared to a net loss of $176.1 million, or $2.26 per share for 2018.

    Cash Position:

    At December 31, 2019, the Company had $545.1 million in cash, cash equivalents and marketable securities, reflecting the December 2019 common stock financing compared to $325.9 million at September 30, 2019.

    2020 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, less stock-based compensation expense, restructuring expense and collaborative reimbursement revenues. Momenta is providing full-year non-GAAP operating expense guidance of $220 - $240 million for 2020.

    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 revenues. 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 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 does not expect restructuring expense and collaboration reimbursement revenue to be material.

    Conference Call Information

    Management will host a conference call and webcast today at 8:30 am ET to discuss these results and provide an update on the Company. A live webcast of the conference call may be accessed on the "Investors" section of the Company's website, www.momentapharma.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call.

    To access the call you may also dial (866) 209-9686 (domestic) or (825) 312-2288 (international)  prior to the scheduled conference call time and provide the access code 8677153.

    About Momenta

    Momenta Pharmaceuticals is a biotechnology company with a validated innovative scientific platform focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases and advancing its late stage biosimilars and is headquartered in Cambridge, MA.

    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 Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.

    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 restructuring expense and 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 September 30, 2019, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. The Company is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    INVESTOR CONTACT: MEDIA CONTACT:
    Patty Eisenhaur Karen Sharma
    Momenta Pharmaceuticals MacDougall Biomedical Communications
    1-617-395-5189 1-781-235-3060





    MOMENTA PHARMACEUTICALS, INC.
    Unaudited Condensed Consolidated Balance Sheets
    (in thousands)
     
      December 31, 2019   December 31, 2018
    Assets      
    Cash, cash equivalents and marketable securities $ 545,110     $ 449,411  
    Collaboration receivable 8,013     11,371  
    Restricted cash 1,849     37,898  
    Other assets 63,393     32,883  
    Total assets $ 618,365     $ 531,563  
           
    Liabilities and Stockholders' Equity      
    Current liabilities $ 106,104     $ 51,511  
    Deferred revenue, net of current portion 940     1,774  
    Other long-term liabilities 56,861     17,270  
    Stockholders' equity 454,460     461,008  
    Total liabilities and stockholders' equity $ 618,365     $ 531,563  
                   


     
     
    MOMENTA PHARMACEUTICALS, INC.
    Unaudited Condensed Statements of Operations and Comprehensive Loss
    (in thousands, except per share amounts)
     
      Three Months Ended December 31,   Year Ended December 31,
      2019   2018   2019   2018
    Collaboration revenues:              
    Product revenue $ 7,879     $ 10,763     $ 19,115     $ 39,684  
    Research and development revenue 303     32,059     4,753     35,905  
    Total collaboration revenue 8,182     42,822     23,868     75,589  
                   
    Operating expenses:              
    Research and development 38,334     28,695     144,542     124,004  
    General and administrative 58,926     21,525     149,822     85,105  
    Other operating (income) expense (1,731 )       41,205     30,000  
    Restructuring (67 )   2,272     110     17,807  
    Gain on lease modification         (13,720 )    
    Total operating expenses 95,462     52,492     321,959     256,916  
                   
    Net loss from operations (87,280 )   (9,670 )   (298,091 )   (181,327 )
                   
    Other income, net 580     1,426     8,036     5,266  
                   
    Net loss $ (86,700 )   $ (8,244 )   $ (290,055 )   $ (176,061 )
                   
    Earnings (net loss) per share:              
    Basic $ (0.85 )   $ (0.10 )   $ (2.92 )   $ (2.26 )
    Diluted $ (0.85 )   $ (0.10 )   $ (2.92 )   $ (2.26 )
                   
    Shares used in calculating net loss per share              
    Basic 101,824     82,087     99,339     77,845  
    Diluted 101,824     82,087     99,339     77,845  
                   
    Comprehensive loss $ (86,865 )   $ (8,168 )   $ (289,672 )   $ (176,008 )
                                   






















     
     
    MOMENTA PHARMACEUTICALS, INC.
    Reconciliation of GAAP Results to Non-GAAP Financial Measures
    (in thousands)
    (unaudited)
     
    A reconciliation of historical GAAP operating expenses to Non-GAAP operating expenses is as follows:
     
      Three Months Ended December 31,   Year Ended December 31,
      2019   2018   2019   2018
                   
    GAAP operating expenses $ 95,462     $ 52,492     $ 321,959     $ 256,916  
    Adjustments:              
    Restructuring 67     (2,273 )   (110 )   (17,807 )
    Non-cash stock compensation expense (8,605 )   (2,498 )   (22,430 )   (17,414 )
    Collaboration expenses that are recorded as revenue and are reimbursable by collaborators (15 )   (518 )   (896 )   (2,468 )
    Non-GAAP operating expenses $ 86,909     $ 47,203     $ 298,523     $ 219,227  


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