Insmed Reports Second Quarter 2017 Financial Results and Provides Business Update
- On Track to Report Top-Line Results from Phase 3 CONVERT Study in September plus or minus one month
- Plan to Initiate Enrollment of Phase 2 Dose-ranging Study of INS1007 in Non-Cystic Fibrosis (non-CF) Bronchiectasis in the Second Half of 2017
U.S. Food and Drug Administration(FDA) Provides Established Name for Lead Development Program - ALIS (amikacin liposome inhalation suspension)
- On track to report top-line results from phase 3 CONVERT study in September plus or minus one month. The CONVERT study, or INS-212, is evaluating amikacin liposome inhalation suspension (ALIS) in treatment refractory NTM lung disease caused by MAC. The primary efficacy endpoint is the proportion of subjects who achieve culture conversion at Month 6 in the ALIS plus multi-drug regimen arm compared to the multi-drug regimen without ALIS arm. The Company reported that the last patient in the study has progressed beyond the Month 6 measure. Additionally,
Insmedreported that the dropout rate observed in the study was lower than the initially assumed dropout rate.
- Plan to initiate enrollment of phase 2 dose-ranging
study of INS1007 in non-cystic fibrosis (non-CF) bronchiectasis in the second half of 2017. INS1007 is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase I (DPP1), an enzyme responsible for activating neutrophil serine proteases in neutrophils when they are formed in the bone marrow. Pending dialogue with the
FDA, Insmedplans to evaluate two doses of INS1007 (10mg and 25mg) vs. placebo over 24 weeks. The primary endpoint is expected to evaluate time to first exacerbation while secondary endpoints are expected to evaluate mechanistic, clinical and outcomes-based measures. Insmedis also evaluating the potential of INS1007 in other indications.
FDAprovides established name for lead development program. The FDArecently advised Insmedthat the established name for its phase 3 product candidate in development for the treatment of refractory nontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC) will be amikacin liposome inhalation suspension, or ALIS.
- Enhanced management team with appointment of chief financial officer, chief medical officer and chief product strategy officer. During the second quarter the company announced changes to its senior leadership team with the appointment of
Paolo Tombesias chief financial officer and Paul Streck, M.D., as chief medical officer. Additionally, Eugene Sullivan, M.D., assumed the newly created role of chief product strategy officer.
"Throughout 2017 we have remained committed to our mission of transforming the lives of patients with rare diseases. We continue to focus on the execution and evaluation of our phase 3 CONVERT study for which we continue to anticipate top-line results in September plus or minus one month. If the study meets the primary endpoint, we intend to complete preparation for a
Second Quarter Financial Results
For the second quarter of 2017, Insmed reported a net loss of $44.7 million, or $0.72 per share, compared with a net loss of $36.6 million, or $0.59 per share, for the second quarter of 2016.
Research and development expenses were $26.9 million for the second quarter of 2017, compared with $23.9 million for the second quarter of 2016. The increase was primarily due to an increase in expenses related to INS1007 and higher compensation and related expenses due to an increase in headcount partially offset by decreases in ALIS manufacturing expenses.
General and administrative expenses for the second quarter of 2017 were $16.6 million, compared with $12.3 million for the second quarter of 2016. The increase was primarily due to higher expenses related to our pre-commercial planning activities for ALIS and higher compensation and related expenses due to an increase in headcount, as compared to the prior year period.
Balance Sheet and Other Financial Highlights
As of June 30, 2017, Insmed had cash and cash equivalents of approximately
Insmed will host a conference call beginning today at 8:30 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (844) 707-0669 (domestic) or (703) 639-1223 (international) and referencing conference ID number 53207980. The call will also be webcast live on the internet on the Company's website at www.insmed.com.
A replay of the conference call will be accessible approximately two hours after its completion through August 17, 2017 by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international) and referencing conference ID number 53207980. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at www.insmed.com.
Non-GAAP Financial Measures
In addition to
Management believes that this non-GAAP financial measure is useful to both management and investors in analyzing our ongoing business and operating performance. Management believes that providing non-GAAP information to investors, in addition to the GAAP presentation, allows investors to view our financial results in the way that management views financial results. Management does not intend the presentation of this non-GAAP financial measure to be considered in isolation or as a substitute for results prepared in accordance with GAAP. In addition, this non-GAAP financial measure may differ from similarly named measures used by other companies.
Insmed Incorporated is a
global biopharmaceutical company focused on the unmet needs of patients with rare diseases. The Company is advancing a global phase 3 clinical study of amikacin liposome inhalation suspension (ALIS) for adult patients with treatment refractory NTM lung disease caused by MAC, a rare and often chronic infection that is capable of causing irreversible lung damage and can be fatal. There are currently no approved inhaled products specifically indicated for the treatment of refractory NTM lung infections caused by MAC in the United States or European Union (EU).
"Insmed" is the Company's trademark. All other trademarks, trade names or service marks appearing in this press release are the property of their respective owners.
This press release contains forward looking statements. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.
The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. Such factors include, among others: uncertainties in the research and development of our existing product candidates, including due to delays in patient enrollment
or failure of our preclinical studies or clinical trials to satisfy pre-established endpoints; failure to develop, or to license for development, additional product candidates, including a failure to attract experienced third party collaborators; failure to obtain, or delays in obtaining, regulatory approval from the
The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the Securities and Exchange Commission, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Financial Statements and Reconciliation Follow
|Consolidated Statements of Net Loss|
|(in thousands, except per share data)|
| Three Months Ended || Six Months Ended |
|Research and development||26,871||23,871||49,125||44,418|
|General and administrative||16,644||12,262||30,359||24,782|
|Total operating expenses||43,515||36,133||79,484||69,200|
|Other income, net||200||32||105||47|
|Loss before income taxes||(44,635||)||(36,561||)||(82,019||)||(70,065||)|
|Income tax provision||37||18||67||46|
|Basic and diluted net loss per share||$||(0.72||)||$||(0.59||)||$||(1.32||)||$||(1.13||)|
|Weighted average basic and diluted common shares outstanding||62,209||61,878||62,126||61,868|
|Consolidated Balance Sheets|
|(in thousands, except par value and share data)|
|As of||As of|
|Cash and cash equivalents||$||91,064||$||162,591|
|Prepaid expenses and other current assets||5,470||5,816|
|Total current assets||96,534||168,407|
|In-process research and development||58,200||58,200|
|Fixed assets, net||9,234||10,020|
|Liabilities and shareholders' equity|
|Other current liabilities||694||728|
|Total current liabilities||26,272||27,989|
|Other long-term liabilities||729||693|
|Common stock, |
|62,376,416 and 62,019,889 issued and outstanding shares at June |
30, 2017 and
|Additional paid-in capital||930,185||919,164|
|Accumulated other comprehensive loss||(42||)||(65||)|
|Total shareholders' equity||83,445||154,483|
|Total liabilities and shareholders' equity||$||165,640||$||237,956|
|Reconciliation of GAAP to Non-GAAP Results|
| Three Months Ended June |
| Six Months Ended June |
|Operating expenses reconciliation:|
|Total operating expenses - GAAP||$||43,515||$||36,133||$||79,484||$||69,200|
|Stock-based compensation expense||(4,559||)||(4,615||)||(8,591||)||(8,834||)|
|Cash-based operating expenses - Non-GAAP||$||38,218||$||30,950||$||69,439||$||59,284|
Blaine DavisVice President, Head of Investor Relations Insmed Incorporated(908) 947-2841 firstname.lastname@example.org
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