Q1 2020 Insmed Inc Earnings Call

Insmed (INSM) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peaks (Biotech stocks hitting 52-week highs May 5.) * Arcturus Therapeutics Ltd (NASDAQ: ARCT) (announced a partnership with Catalent Inc (NYSE: CTLT) for manufacturing of a vaccine against the novel coronavirus) * BIO-TECHNE Corp (NASDAQ: TECH) * Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO) * ChemoCentryx Inc (NASDAQ: CCXI) * DexCom, Inc. (NASDAQ: DXCM) (received Health Canada temporary authorization for its Dexcom G6 CGM for use in hospitals to monitor critically ill patients during COVID-19 pandemic) * Halozyme Therapeutics, Inc. (NASDAQ: HALO) (announced FDA approval for Johnson & Johnson (NYSE: JNJ) Janssen unit's subcutaneous formulation of Darzalex, which uses Halozyme's Enhanze technology, in treating multiple myeloma) * Imara Inc (NASDAQ: IMRA) * Immunomedics, Inc. (NASDAQ: IMMU) (announced the commercial availability of its recently-approved breast cancer drug Trodelvy in the U.S.) * Masimo Corporation (NASDAQ: MASI) * Minerva Neurosciences Inc (NASDAQ: NERV) * Vermillion, Inc. (NASDAQ: VRML) * Zynex Inc. (NASDAQ: ZYXI)None of the biotech/medical devices/diagnostics company hit 52-week lows Monday.Stocks In Focus Adverum's Gene Therapy Shows Robust Efficacy, Safety In Phase 1 Study For Wet Age-Related Macular Degeneration Adverum Biotechnologies Inc (NASDAQ: ADVM) announced new interim clinical data from Cohorts 1-3 of the OPTIC Phase 1 dose-ranging clinical study of single-dose of ADVM-022 intravitreal injection gene therapy in patients with wet age-related macular degeneration, which further demonstrated the transformative potential of ADVM-022 to greatly reduce anti-VEGF injection burden in wet AMD."It's impressive to see the long-term durability demonstrated at the higher dose of ADVM-022 in a patient population that previously required frequent injections to maintain their vision and are now beyond one year of follow-up with no rescue injections," Arshad Khanani, the study's principal investigator, said in a statement.The company also offered a business update, reporting cash, cash equivalents and short-term investments of $297 million as of March 31. Adverum said it expects to submit a NDA for ADVM-022 in diabetic retinopathy in the first half of 2020 and present data from all four cohorts of the OPTIC trial in the second half.Bio-Rad Droplet Digital PCR Test Kit For Coronavirus Receives EUA Bio-Rad said its SARS-CoV-2 Droplet Digital PCR test kit has been granted Emergency Use Authorization by the FDA. The SARS-CoV-2 Droplet Digital PCR test runs on Bio-Rad's QX200 and QXDx ddPCR systems.Chembio's Serological Test For Coronavirus Gets CE Marking Chembio Diagnostics Inc (NASDAQ: CEMI) said it has attained the CE Marking for its DPP COVID-19 System. The CE Marking allows the company commercialize the system within the member states of the European Union and the Caribbean region, except for Puerto Rico.The DPP COVID-19 System is a serological test and analyzer that provides numerical readings for both IgM and IgG antibody levels within 15 minutes from a simple finger stick drop of blood. The test has received EUA in the U.S.Separately, the company reported first-quarter results, showing a 20% decline in revenue to $6.9 million and a wider net loss of 29 cents per share.In premarket trading Tuesday, the stock was gaining 17.47% to $14.39.View more earnings on IBBSee also: Attention Biotech Investors: Mark Your Calendar For These May PDUFA Dates Regeneron, Sanofi Say PD-1 Inhibitor Libtayo Found Effective In Skin Cancer In Pivotal Study Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Sanofi SA (NASDAQ: SNY) announced top-line data from a pivotal, single-arm, open-label trial of PD-1 inhibitor Libtayo in patients with advanced basal cell carcinoma who had progressed on or were intolerant to prior hedgehog pathway inhibitor therapy. The data showed the investigational asset demonstrated clinically meaningful and durable responses in this group of patients for whom there are currently no approved treatments.The companies said they plan regulatory submissions in 2020.Libtayo was approved in September 2018 by the FDA to treat patients with metastatic cutaneous squamous cell carcinoma.Insmed Announces Secondary Offering Of Common Stock Insmed Incorporated (NASDAQ: INSM) said it intends to offer and sell shares of its common stock in an underwritten public offering. All the shares are being offered by the company.The stock was down 0.84% at $24.65 in Tuesday's premarket session.Earnings GenMark Diagnostics, Inc (NASDAQ: GNMK) announced first-quarter revenue of $38.7 million, in line with the number it mentioned in its April 8 pre-announcement and representing an 80% year-over-year increase. The loss per share narrowed from 21 cents to 12 cents, while analysts estimated a loss of 14 cents per share.The company raised its full-year revenue guidance to $120 million to $130 million, ahead of the $108.58-million consensus estimate, and it also increased its gross margin guidance to 38-40%.Separately, GenMark announced the appointment of Scott Mendel as CEO. Mendel has been serving as CEO on an interim basis since February.The stock was up 13.29% at $13.30 in the premarket session.On The Radar Earnings * Oxford Immunotec Global PLC (NASDAQ: OXFD) (before the market open) * Karyopharm Therapeutics Inc (NASDAQ: KPTI) (before the market open) * Haemonetics Corporation (NYSE: HAE) (before the market open) * Antares Pharma Inc (NASDAQ: ATRS) (before the market open) * Harvard Bioscience, Inc. (NASDAQ: HBIO) (before the market open) * Vericel Corp (NASDAQ: VCEL) (before the market open) * Regeneron * Neuronetics Inc (NASDAQ: STIM) (before the market open) * Mallinckrodt PLC (NYSE: MNK) (before the market open) * Akebia Therapeutics Inc (NASDAQ: AKBA) (before the market open) * Agile Therapeutics Inc (NASDAQ: AGRX) (after the market close) * Aquestive Therapeutics Inc (NASDAQ: AQST) (after the market close) * Akcea Therapeutics Inc (NASDAQ: AKCA) (after the market close) * Acorda Therapeutics Inc (NASDAQ: ACOR) (after the market close) * Axonics Modulation Technologies Inc (NASDAQ: AXNX) (after the market close) * Synthetic Biologics Inc (NYSE: SYN) (after the market close) * T2 Biosystems Inc (NASDAQ: TTOO) (after the market close) * Iovance Biotherapeutics Inc (NASDAQ: IOVA) (after the market close) * MacroGenics Inc (NASDAQ: MGNX) (after the market close) * Zogenix, Inc. (NASDAQ: ZGNX) (after the market close) * Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) (after the market close) * Exelixis, Inc. (NASDAQ: EXEL) (after the market close) * Myriad Genetics, Inc. (NASDAQ: MYGN) (after the market close) * Inspire Medical Systems Inc (NYSE: INSP) (after the market close) * Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) (after the market close) * Supernus Pharmaceuticals Inc (NASDAQ: SUPN) (after the market close) * Nevro Corp (NYSE: NVRO) (after the market close) * Clovis Oncology Inc (NASDAQ: CLVS) (after the market close) * InVitae Corp (NYSE: NVTA) (after the market close) * Cytosorbents Corp (NASDAQ: CTSO) (after the market close) * Cardiovascular Systems Inc (NASDAQ: CSII) (after the market close) * Cerus Corporation (NASDAQ: CERS) (after the market close) * Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) (after the market close) * Incyte Corporation (NASDAQ: INCY) (after the market close) * Orthopediatrics Corp (NASDAQ: KIDS) (after the market close)Related Link: The Week Ahead In Biotech: Smid-Cap Earnings News Flow Picks Up Pace See more from Benzinga * The Daily Biotech Pulse: Gilead Slips Despite Forecast-Beating Q1, Moderna Partners With Lonza For Coronavirus Vaccine Production, Lyra Therapeutics IPO(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today reported financial results for the first quarter ended March 31, 2020, and provided a business update.

Insmed (INSM) delivered earnings and revenue surprises of -10.45% and 9.20%, respectively, for the quarter ended March 2020. Do the numbers hold clues to what lies ahead for the stock?

Insmed Incorporated (Nasdaq: INSM) announced today the closing of the previously announced public offering of 11,155,000 shares of its common stock, including 1,455,000 shares issued pursuant to the exercise in full of the underwriters' option to purchase additional shares, at a public offering price of $23.25 per share. The gross proceeds to Insmed from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Insmed, were approximately $259.4 million.

Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that Will Lewis, Chairman and Chief Executive Officer of Insmed, will present at the following virtual investor conferences:

Insmed Incorporated (Nasdaq: INSM) announced today that it priced a registered underwritten public offering of 9,700,000 shares of its common stock at a price to the public of $23.25 per share. The gross proceeds to Insmed from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Insmed, are expected to be approximately $225.5 million. In addition, Insmed has granted the underwriters a 30-day option to purchase up to an additional 1,455,000 shares of common stock.

Insmed (INSM) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that it will provide funding and clinical drug supply for the STOP-COVID19 (Superiority Trial of Protease inhibition in COVID-19) trial, an investigator-initiated study of brensocatib (formerly known as INS1007) in up to 300 hospitalized patients with COVID-19 sponsored by the University of Dundee. The study, which has been prioritized and designated an Urgent Public Health trial by the UK's National Institute for Health Research, is expected to begin enrollment in May 2020.

Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced the granting of inducement awards to 11 new employees. In accordance with NASDAQ Listing Rule 5635(c)(4), the awards were approved by Insmed's Compensation Committee and made as a material inducement to each employee's entry into employment with the Company.

Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that new data from the Phase 2 WILLOW study of brensocatib (formerly known as INS1007) in non-cystic fibrosis bronchiectasis (NCFBE) will be presented during a virtual clinical trials session hosted by the American Thoracic Society (ATS) on Wednesday, June 24, 2020, at 2:00 pm ET. Data will be presented by lead study investigator James Chalmers, MBChB, Ph.D., Professor and Consultant Respiratory Physician at the School of Medicine, University of Dundee, UK. Insmed will hold a conference call following the oral session during which Professor Chalmers will further discuss the WILLOW data and Insmed management will provide a business assessment of brensocatib.

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As you might know, Insmed Incorporated (NASDAQ:INSM) recently reported its first-quarter numbers. It looks like a...

Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that it will release its first quarter 2020 financial results on Thursday, April 30, 2020.

Shares of Insmed (NASDAQ:INSM) were unchanged at $21.05 after the company reported Q1 results.Quarterly Results Earnings per share increased 22.92% year over year to ($0.74), which missed the estimate of ($0.71).Revenue of $36,860,000 higher by 68.30% from the same period last year, which beat the estimate of $34,800,000.Looking Ahead Earnings guidance hasn't been issued by the company for now.Revenue guidance hasn't been issued by the company for now.Conference Call Details Date: Apr 30, 2020View more earnings on INSMTime: 11:01 AM ETWebcast URL: https://www.webcaster4.com/Webcast/Page/2000/34294Recent Stock Performance 52-week high: $34.94Company's 52-week low was at $12.09Price action over last quarter: down 20.02%Company Description Insmed Inc is a global biopharmaceutical company transforming the lives of patients with serious and rare diseases. The company's first commercial product is ARIKAYCE (amikacin liposome inhalation suspension), approved in the US for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. The company's earlier-stage clinical pipeline includes INS1007, a novel oral reversible inhibitor of dipeptidyl peptidase 1 with therapeutic potential in non-cystic fibrosis bronchiectasis and other inflammatory diseases, and INS1009, an inhaled formulation of a treprostinil prodrug that may offer a differentiated product profile for pulmonary arterial hypertension.See more from Benzinga * Recap: Patrick Industries Q1 Earnings * Superior Group: Q1 Earnings Insights * Recap: Independent Bank Q1 Earnings(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

INSM earnings call for the period ending March 31, 2020.

And they’re off to the races. All three of the major U.S. stock indexes popped on Monday after biotech company Moderna reported its experimental COVID-19 vaccine produced encouraging results in its Phase 1 trial, with it appearing to be safe and able to generate an immune response against the virus.While the news has inspired optimism among market watchers, one investing guru is saying slow your roll. Billionaire Steve Cohen told the employees of his investment firm, Point72 Asset Management, to use caution amid the market’s slight rebounds from low points.In a note to his staff, Cohen wrote, “Markets don’t come back in a straight line; after an earthquake there are tremors. We need to continue to be disciplined. We are seeing plenty of opportunities to generate returns, but I don’t want us taking undue risks.”Using what’s known as a multi-strategy approach which involves stock market investments as well as global investments in several asset classes all at once based on macroeconomic trends, Cohen is considered one of the best in the business. The legendary stock picker has the track record to back up his reputation.Taking a page from Cohen’s playbook, we scanned a recent 13F filing disclosing Point72’s recent buys and found three healthcare stocks that looked promising. After running each through TipRanks’ database, we learned that some Wall Street analysts are also avid fans of the Buy-rated tickers.Verastem (VSTM)Targeting the critical signaling pathways in cancer, Verastem is developing a diverse portfolio of small molecule drugs that could potentially stop the disease in its tracks. Based on this pipeline that includes phosphoinositide 3-kinase (PI3K) and focal adhesion kinase (FAK) inhibitors, some see significant gains in VSTM’s future. Cohen is among those that have high hopes for this healthcare name. Pulling the trigger on VSTM for the first time, Point72 purchased more than 6.1 million shares. The value of the firm’s new holding comes in at over $16 million.Meanwhile, five-star analyst Alethia Young, of Cantor Fitzgerald, cites recently released data on VS-6766 and Defactinib in ovarian and non-small-cell lung carcinoma (NSCLC) as the major component of her bullish thesis. For ovarian cancer, a 67% response rate was seen in six patients in the KRAS subgroup.The candidate also demonstrated activity in a subgroup of NSCLC KRAS G12V patients, with it producing a 10% response rate in the overall KRAS group of ten patients treated in the combo study. This suggests that G12V was the main driver of the effect. Young added, “In addition to the investigator run NSCLC cohort, VSTM studied G12V in another seven patients achieving a 57% ORR.” Additionally, while toxicities related to MEK/RAF and FAK were expected, the go forward dose appeared to be tolerable.Expounding on the implications of the data, Young said, “We find these data encouraging based on current market cap size since they have found likely two indications in subgroups where the monotherapy or combinations are active. We wonder if there will be questions around not seeing activity in the broader KRAS NSCLC subgroup, but overall we think this early signal in a hard to treat KRAS subgroup population is positive.”It should also be noted that challenging experiences with PI3K delta have created some headwinds, but Young still thinks the commercial potential for these therapies is underappreciated by investors. “Verastem’s Copiktra is approved for CLL and FL/SLL, which are two large markets. Our doctor checks suggest that PI3K is a viable class certainly in relapsed or refractory patients,” she stated.Bearing this in mind, Young left an Overweight rating and $6 price target on the stock. Should this target be met, a twelve-month gain of 233% could be in store. (To watch Young’s track record, click here)Looking at the consensus breakdown, 2 Buys and 1 Hold add up to a Moderate Buy analyst consensus. At $4.50, the average price target implies nearly 149% upside potential. (See Verastem stock analysis on TipRanks)Amicus Therapeutics (FOLD)Focused on delivering high-quality therapies for people living with rare metabolic diseases, Amicus Therapeutics takes its place at the forefront of the space. With a jam-packed development pipeline, it’s no wonder FOLD has scored fans. Cohen’s firm just gave the healthcare stock a nod of approval. Acquiring a new FOLD holding, Point72 picked up 2,242,900 shares valued at $20,724,000.Turning now to the analyst community, FOLD has received significant support. One of the analysts in its corner is Leerink's Joseph Schwartz, who points out that despite the COVID-19 pandemic, FOLD exceeded expectations for Q1 2020 revenue thanks to high pt. demand. The five-star analyst also noted, “Favorable reimbursement dynamics also continued to tailwinds for Galafold sales in Q1 2020. As strong adoption of Galafold continues, FOLD management reiterated that revenue continues to track towards full-year 2020 guidance of $250 to $260 million.”Additionally, Schwartz argues that in the last year, FOLD has increased its focus on cost management while still remaining committed to developing its product candidates, helping the company “turn a corner.” As part of this strategy, more cost saving initiatives have been put in place to mitigate any impacts from COVID-19, allowing its cash runway to extend through the second half of 2022.Most exciting for Schwartz, though, is that Phase 3 PROPEL for AT-GAA, its “crown jewel”, remains on track and manufacturing and supply is intact globally. Adding to the good news, AT-GAA was granted a rolling BLA submission, which is set to start in the second half of this year. This means that top-line data could be released in the first half of 2021.As the development of FOLD’s gene therapy portfolio is also progressing, with it planning to have clinical development, manufacturing and regulatory discussions for both the CLN6 and CLN3 Battens gene therapy programs, the deal is sealed for Schwartz.To this end, Schwartz maintained an Outperform call and $19 price target. This target conveys his confidence in FOLD’s ability to climb 51% higher in the next year. (To watch Schwartz’s track record, click here)What does the rest of the Street think about FOLD? It turns out that other analysts also have high hopes. With 5 Buys and a single Hold, the word on the Street is that this stock is a Strong Buy. In addition, the $20.58 average price target puts the upside potential at 65%. (See Amicus stock analysis on TipRanks)Insmed (INSM)Last but not least we have Insmed, which works on developing effective therapies for patients suffering from serious and rare diseases. While COVID-19 has weighed on the company, there are major catalysts on the horizon that could potentially fuel upside for shares.Point72 takes its place on the bulls’ side. Boosting its holding by a whopping 1,283%, the firm snapped up 3.3 million shares. As for the value of this new addition, it lands at $53.4 million.Like Cohen, H.C. Wainwright analyst Andrew Fein is optimistic. “In spite of investor uncertainty associated the with COVID-19 pandemic, we view the apparent progression of all pipeline programs in lieu of such headwinds as positive for the stock,” Fein commented.Looking specifically at ARIKAYCE, growth has slowed as a result of the public health crisis, but the five-star analyst argues that several factors suggest the momentum for sales growth will persist. These include the submission of an NDA in March in Japan, which boasts the largest diagnosed MAC lung disease population, and the pending EU marketing authorization. This would set INSM up for a Germany launch by year-end, followed up by a UK launch shortly after.The most noteworthy potential catalyst in terms of prescriptions and determining treatment duration, though, will be updated guidelines from both the American Thoracic Society (ATS) and the Infectious Disease Society of America (IDSA). It also doesn’t hurt that there’s a peer-reviewed paper offering solutions to address the adverse events that are sometimes witnessed with ARIKAYCE use and a patient reported outcome (PRO) tool for ARIKAYCE in non-tuberculosis (NTM) disease is being developed, with the trial kicking off in the beginning of the second half of 2020.Fein added, “Insmed announced that it has not yet observed any disruptions in the supply chain for ARIKAYCE production and should be able to meet global demand through 2022...Insmed believes that the current climate is causing a bolus of patients, which could lead to a major upswing in patients being treated with ARIKAYCE in 2H20.”If that wasn’t enough, Brensocatib, formerly INS1007, is on a clear path to Phase 3 trial initiation in bronchiectasis and is being studied in severe COVID-19 patients. “We feel the development of Brensocatib remains promising as we recall the announcement that AstraZeneca decided to exercise the first option to advance Brensocatib development in chronic obstructive pulmonary disease (COPD) or asthma patients,” Fein noted. Treprostinil Palmitil, previously INS1009, could also see Phase 1 initiation in pulmonary arterial hypertension in the second half of 2020.Based on all of the above, Fein reiterated his Buy rating and $52 price target. Given this target, shares could skyrocket 103% in the next twelve months. (To watch Fein’s track record, click here)With only Buy ratings assigned in the last three months, 6 to be exact, the message is clear: INSM is a Strong Buy. The $47.83 average price target is less aggressive than Fein’s, but it still leaves room for 87% upside potential. (See Insmed stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.

Insmed Incorporated (Nasdaq: INSM) announced today that it intends to offer and sell shares of its common stock in an underwritten public offering. In addition, Insmed intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the shares to be sold in the offering are to be sold by Insmed. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.