XENT Intersect ENT Inc.

17.56
-0.18  -1%
Previous Close 17.74
Open 17.87
52 Week Low 5.97
52 Week High 31.46
Market Cap $574,248,595
Shares 32,702,084
Float 32,373,468
Enterprise Value $517,822,970
Volume 434,195
Av. Daily Volume 343,711
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
ASCEND
Sinus Balloon
Phase 3
Phase 3
Data released October 7, 2019 did not meet primary endpoint.
SINUVA - ENCORE
Nasal polyps
Phase 3
Phase 3
Phase 3 trial met primary endpoints - February 25, 2019.
SINUVA Sinus Implant
Recurrent sinus obstruction
Approved
Approved
Approval announced December 11, 2017.
Propel
Frontal Sinus Disease
Approved
Approved
Approved March 2016

Latest News

  1. Novel navigation technology and recently FDA-cleared sinuplasty balloon expand Intersect ENT's commercial product portfolio

    Extends Intersect ENT's footprint in U.S. and European ENT physicians' offices

    Intersect ENT, Inc. (NASDAQ:XENT), a company transforming care for patients with ear, nose and throat ("ENT") conditions, today announced it has entered into an agreement to acquire Fiagon AG Medical Technologies, a leader in electromagnetic surgical navigation solutions, for €60 million in cash. Under the terms of the transaction, Intersect ENT will make an initial €15 million payment at the time of the closing and €15 million annual payments for the subsequent three years. The acquisition is expected to close within 30 days, subject to…

    Novel navigation technology and recently FDA-cleared sinuplasty balloon expand Intersect ENT's commercial product portfolio

    Extends Intersect ENT's footprint in U.S. and European ENT physicians' offices

    Intersect ENT, Inc. (NASDAQ:XENT), a company transforming care for patients with ear, nose and throat ("ENT") conditions, today announced it has entered into an agreement to acquire Fiagon AG Medical Technologies, a leader in electromagnetic surgical navigation solutions, for €60 million in cash. Under the terms of the transaction, Intersect ENT will make an initial €15 million payment at the time of the closing and €15 million annual payments for the subsequent three years. The acquisition is expected to close within 30 days, subject to customary closing conditions.

    "Fiagon represents a strategic technology acquisition for Intersect ENT that immediately expands our portfolio of ENT product offerings, complements our existing PROPEL® and SINUVA® sinus implants and helps extend our geographic reach," said Thomas A. West, President and CEO of Intersect ENT. "Fiagon develops, and commercializes globally, innovative electromagnetic surgical navigation systems and an associated suite of surgical tools targeted to the ENT surgical space. In addition, in August of 2020 Fiagon received US FDA 510K clearance for a navigable sinuplasty balloon. The combination of the Intersect ENT and Fiagon portfolios allows Intersect ENT to deliver more comprehensive surgical solutions across the sinusitis care continuum regardless of site of care. This deal is consistent with our intention to provide comprehensive value-added and evidenced-based solutions for ENT physicians and the patients they serve."

    Founded in 2007, Fiagon's mission is to improve patient outcomes by equipping physicians with its proprietary, easy-to-use, accurate and integrated surgical navigation solutions. Fiagon's navigation system supports both routine and complex ENT procedures enabling surgeons to track the full range of instruments deployed during a functional endoscopic sinus surgery (FESS) procedure. Fiagon's proprietary instruments are tip-tracked and do not require calibration making them extremely intuitive and easy to use. The instruments and sinuplasty balloon can be bent and adjusted to accommodate various anatomical structures within the sinuses, allowing ENT surgeons to maximize efficiency within their procedures.

    "We are excited to join the team at Intersect ENT, an established leader with an advanced therapeutic platform in the large and attractive global ENT market," said Dr. Kai Desinger, President and CEO of Fiagon Group. "The combination of Intersect ENT's compelling product offerings coupled with its deep commercial leadership expertise and impressive sales force offers a unique opportunity for us to jointly leverage our core innovation and commercialization competencies. We look forward to working with the Intersect ENT team to expand market penetration of our instruments and tools globally."

    The transaction is expected to close in the fourth quarter of 2020 and will be financed using balance sheet cash. The acquisition is expected to be accretive to top-line growth in the first year post close.

    Goldman Sachs & Co. LLC is acting as exclusive financial advisor to Intersect ENT and Cooley LLP and Fieldfisher (Germany) LLP are acting as its legal counsel. Oppenheimer is acting as financial advisor to Fiagon and Morrison & Foerster LLP is acting as its legal counsel.

    About Intersect ENT

    Intersect ENT is a company transforming care for patients with ear, nose and throat conditions. The Company's steroid releasing implants are designed to provide mechanical spacing and deliver targeted therapy to the site of disease. In addition, Intersect ENT is continuing to expand its portfolio of products based on the Company's unique localized steroid releasing technology and is committed to broadening patient access to less invasive and more cost-effective care.

    For additional information on the Company or the products including risks and benefits please visit www.IntersectENT.com. For more information about PROPEL® (mometasone furoate) sinus implants and SINUVA® (mometasone furoate) sinus implant, please visit www.PROPELOPENS.com and www.SINUVA.com.

    Intersect ENT®, PROPEL® and SINUVA® are registered trademarks of Intersect ENT, Inc.

    About Fiagon

    Fiagon develops and manufactures state-of-the-art surgical navigation equipment with its proprietary tip-tracked technology. Over the past ten years Fiagon, along with world-renowned physicians, changed the standard of ENT navigation with its easy-to-use electromagnetic based technology. This unique technology is also currently used in oral and maxillofacial surgery, neurosurgery and spine surgery, outside the US, mainly in Europe and Asia.

    Forward-Looking Statements

    The statements in this press release regarding Intersect ENT's continued growth and financial outlook are "forward-looking" statements. These forward-looking statements are based on Intersect ENT's current expectations and inherently involve significant risks and uncertainties. These statements and risks include Intersect ENT's ability to provide solutions to improve surgical outcomes, to expand the use and adoption of its current products and advance its pipeline, to grow the business, to obtain and maintain FDA or other regulatory approvals, to procure and maintain adequate coverage and reimbursement for our products and/or the procedures in which they are used, the projection that the transaction will be accretive to Intersect ENT's top-line growth in the first year, and Intersect ENT's projections about the positive impacts of the acquisition of Fiagon and its products. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which are described in the company's filings on Form 10-K, Form 10-Q and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov). Intersect ENT does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    View Full Article Hide Full Article
  2. Agreement expands patient access to SINUVA treatment with announcement of third partnership with a specialty pharmacy

    Intersect ENT, Inc. (NASDAQ:XENT), a company transforming care for patients with ear, nose and throat (ENT) conditions, today announced that it has executed a pharmacy services agreement with AllianceRx Walgreens Prime for national specialty pharmacy distribution of the Company's SINUVA® (mometasone furoate) Sinus Implant.

    The agreement will facilitate broader physician and patient access to SINUVA by using the expertise and established specialty pharmacy infrastructure of AllianceRx Walgreens Prime to dispense SINUVA through either a patient's medical or pharmacy insurance benefit. This efficient and scaled approach will…

    Agreement expands patient access to SINUVA treatment with announcement of third partnership with a specialty pharmacy

    Intersect ENT, Inc. (NASDAQ:XENT), a company transforming care for patients with ear, nose and throat (ENT) conditions, today announced that it has executed a pharmacy services agreement with AllianceRx Walgreens Prime for national specialty pharmacy distribution of the Company's SINUVA® (mometasone furoate) Sinus Implant.

    The agreement will facilitate broader physician and patient access to SINUVA by using the expertise and established specialty pharmacy infrastructure of AllianceRx Walgreens Prime to dispense SINUVA through either a patient's medical or pharmacy insurance benefit. This efficient and scaled approach will further simplify the product ordering, fulfillment and treatment process for ENT medical practices and their patients.

    "Intersect ENT is thrilled to add AllianceRx Walgreens Prime as a new partner. AllianceRx Walgreens Prime is a nationwide leader in specialty pharmacy distribution with established relationships among a wide array of payers, notably among many of the Blue Cross Blue Shield health plans," said Thomas A. West, President and Chief Executive Officer of Intersect ENT. "Over 80 percent of commercially insured lives cover SINUVA. This partnership will enhance access and our ability to make SINUVA available to patients who may benefit from our unique office-based treatment for recurrent nasal polyps. AllianceRx Walgreens Prime brings deep expertise in dispensing pharmaceutical products to the physician's office in the service of both pharmacy and medical benefit options of various insurance plans."

    SINUVA is a non-surgical, corticosteroid-eluting implant for the treatment of nasal polyps in adult patients who have had ethmoid sinus surgery. Its innovative 2-in-1 design incorporates a self-expanding, bioabsorbable implant structure along with the targeted delivery of an anti-inflammatory corticosteroid, mometasone furoate. It provides localized drug delivery for up to 90 days directly to the site of disease. By nature of its design as an office-administered implant with direct delivery of anti-inflammatory medication, SINUVA minimizes the reliance on patient compliance. SINUVA is clinically proven to reduce polyps and the need for revision nasal surgery, as well as improve the symptoms of nasal polyps, nasal obstruction, congestion and decreased sense of smell.

    "AllianceRx Walgreens Prime is pleased to have the opportunity to work collaboratively with Intersect ENT in helping to expand the availability of SINUVA to ENT practices and their patients," says Tracey James, Vice President of Pharmacy Services, at AllianceRx Walgreens Prime. "We believe SINUVA fits strategically into our distribution of novel and innovative drug therapies that cost-effectively improve the outcomes of patients who are managing complex, chronic conditions."

    About Intersect ENT

    Intersect ENT is dedicated to transforming care for patients with ear, nose and throat conditions. The Company's steroid-releasing implants are designed to provide mechanical spacing and deliver targeted therapy to the site of disease. In addition, Intersect ENT is continuing to expand its portfolio of products based on the Company's unique localized steroid releasing technology and is committed to broadening patient access to less invasive and more cost-effective care.

    For additional information on Intersect ENT or its products, including risks and benefits, please visit www.IntersectENT.com. For more information about PROPEL® (mometasone furoate) sinus implants and SINUVA® (mometasone furoate) sinus implant, please visit www.PROPELOPENS.com and www.SINUVA.com.

    Intersect ENT®, PROPEL® and SINUVA® are registered trademarks of Intersect ENT, Inc.

    About AllianceRx Walgreens Prime

    AllianceRx Walgreens Prime (alliancerxwp.com) is a specialty and home delivery pharmacy that strives to provide exceptional care throughout a patient's treatment journey with the medicines they need every day. Formed in 2017 through a collaboration between Walgreens, one of the nation's largest chain drug stores, and Prime Therapeutics, a leading pharmacy benefit manager, the company offers tools and resources for patients, providers and health plans to deliver optimal health outcomes. The company is headquartered in Orlando, Fla. and its pharmacies are accredited by several national pharmacy accreditation services.

    SINUVA Indication & Important Safety Information

    INDICATION

    SINUVA Sinus Implant is a prescription steroid-releasing (mometasone furoate) implant indicated for the treatment of nasal polyps in patients 18 years or older who have had ethmoid sinus surgery.

    IMPORTANT SAFETY INFORMATION

    Who should not use SINUVA?

    Do not use SINUVA if you are allergic to mometasone furoate or any ingredients of the implant.

    What should I tell my doctor before receiving SINUVA?

    Before you receive SINUVA, tell your doctor about all medical conditions you have including nasal/sinus problems (such as nasal ulcers or trauma), eye problems (such as glaucoma or cataracts), or any untreated fungal, bacterial, or viral infections.

    What are the possible side effects of SINUVA?

    Serious side effects of SINUVA can include:

    • Local reactions including nosebleed and injury to nerves or blood vessels in the nose/sinus.
    • Serious allergic reactions have happened in patients using mometasone furoate including rash, itching or swelling of the lips, face, tongue, and throat, and breathing problems. Call your doctor right away if you have any of these reactions.
    • Weakened immune system that may increase your risk of infections. Avoid contact with people who have contagious diseases such as chickenpox or measles. Call your doctor right away if you have been near someone with chickenpox or measles.
    • Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones and can cause tiredness, weakness, nausea and vomiting and low blood pressure. Talk to your doctor if steroid effects such as Cushing Syndrome and adrenal suppression appear.

    The most common side effects of SINUVA in clinical studies were bronchitis, cold symptoms, middle ear infections, headache, lightheadedness or dizziness, asthma, and nosebleeds. The following adverse reactions have been identified during post-approval use of the SINUVA sinus implant. These events include implant migration, lack of efficacy, nasal pain, headache, and nosebleeds.

    Tell your doctor if you have any side effects that bother you or don't go away.

    Risks related with the insertion and removal of SINUVA are similar to other endoscopic sinus procedures.

    SINUVA is made from materials designed to soften over time and may fall out of the nose on its own as polyps decrease or if you sneeze or blow your nose forcefully. The implant will be removed 90 days after placement or earlier at your doctor's discretion.

    Contact your doctor immediately if you have any changes in vision, excessive nasal bleeding, symptoms of infection or symptoms suggesting that the implant has moved, such as irritation or a choking sensation in the back of the throat.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. For important risk and use information, please see Full Prescribing Information for SINUVA (www.SINUVA.com/PI)

    Forward-Looking Statements

    This release contains forward-looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. We may, in some cases, use terms such as "look forward," confident," "promises," "predicts," "believe," "potential," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward-looking statements are based on Intersect ENT's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation those related to the safety, efficacy and patient and physician adoption of the company's products and therapies, the ability to obtain and maintain reimbursement codes for its products, the company's ability to procure and maintain required regulatory approvals for our products, the company's ability to grow and expand its business, the Company's ability to enhance and facilitate broader patient access to SINUVA, as well as other risks detailed from time to time in Intersect ENT's filings with the Securities and Exchange Commission (SEC), including Intersect ENT's filings on Form 10-K and Form 10-Q available at the SEC's Internet site (www.sec.gov). Intersect ENT does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    View Full Article Hide Full Article
  3. Intersect ENT, Inc. (NASDAQ:XENT), a company transforming care for patients with ear, nose and throat ("ENT") conditions, today reported financial results for the second quarter ended June 30, 2020.

    Second Quarter 2020 Overview

    • Revenue of $9.8 million in the second quarter of 2020, compared to $26.7 million in the second quarter of 2019
    • Strong sales trend reinforces confidence in sequential second half revenue growth
    • Cash, Cash Equivalents and Short-term Investments of $135.8 million

    Total revenue was $9.8 million for the second quarter of 2020 compared to $26.7 million for the same period of 2019. This year-on-year decrease was attributable to hospitals suspending elective surgical procedures, and reduced ENT office visits, as a…

    Intersect ENT, Inc. (NASDAQ:XENT), a company transforming care for patients with ear, nose and throat ("ENT") conditions, today reported financial results for the second quarter ended June 30, 2020.

    Second Quarter 2020 Overview

    • Revenue of $9.8 million in the second quarter of 2020, compared to $26.7 million in the second quarter of 2019
    • Strong sales trend reinforces confidence in sequential second half revenue growth
    • Cash, Cash Equivalents and Short-term Investments of $135.8 million

    Total revenue was $9.8 million for the second quarter of 2020 compared to $26.7 million for the same period of 2019. This year-on-year decrease was attributable to hospitals suspending elective surgical procedures, and reduced ENT office visits, as a result of the COVID-19 pandemic. Revenue for the PROPEL® family of products for the quarter was $9.5 million. For the quarter, the Company generated significant revenue improvements with monthly revenues of $700 thousand, $3.1 million and $6.0 million in April, May and June, respectively. This trend continued with preliminary sales of approximately $8.2 million in July 2020.

    "While well below last year, we achieved stronger than expected second quarter revenues led by the return of sinus surgery procedures using PROPEL as the U.S. market began to overcome the challenges of the COVID-19 pandemic," said Thomas A. West, President and CEO. "Our revenue performance reflected increasing momentum in the quarter with May stronger than a very soft April and June stronger than May. This momentum stemmed from the continued refinement, investment and improvement in our commercial execution on top of the pent-up demand of untreated patients awaiting care for chronic rhinosinusitis. In addition to steadily improving PROPEL volumes, SINUVA patient referrals also experienced a progressive rise throughout the quarter. We anticipate continued increases in elective sinus procedures that will drive sequential revenue growth during the second half of 2020, a trend we are already seeing as evidenced by our strong revenue performance in July."

    During the second quarter of 2020, the Company incurred idle facility charges of $4.4 million associated with the COVID-19 pandemic that reduced gross margin by approximately 45%. As a result, gross profit for the second quarter of 2020 was $2.4 million and gross margin was 25%, compared to gross profit of $21.6 million and gross margin of 81% for the same period of 2019. The Company expects gross margin to steadily improve in the second half of 2020 as, and to the extent, volume and production return to normal.

    Operating expenses for the second quarter of 2020 were $23.5 million, compared to $33.7 million in the same period of 2019, reflecting the Company's cost reduction actions to curtail spending given the uncertainties of the COVID-19 pandemic. R&D expenses decreased to $4.0 million from $6.0 million for the same period of 2019 as the Company delayed starting certain clinical efforts until later in 2020. SG&A expenses decreased to $19.5 million from $27.6 million for the same period of 2019.

    Net loss for the second quarter of 2020 was $23.1 million, or $0.71 per share, compared to $11.4 million, or $0.36 per share, in the same period of 2019. Adjusted net loss for the second quarter of 2020 was $21.1 million, or $0.65 per share. Adjusted net loss excludes $1.8 million in losses on embedded derivatives and $0.2 million in restructuring costs. There were no adjustments in the same period of 2019.

    The balance of cash, cash equivalents and short-term investments as of June 30, 2020 was $135.8 million, compared to $90.6 million at the start of the year. As previously announced, the Company expects to achieve approximately $40.0 million in cash savings for the full-year 2020 from its cost reduction efforts. For the second quarter of 2020, the Company slightly exceeded its cost savings plan realizing approximately $15.0 million in cash savings.

    Outlook

    As previously announced, due to the rapidly evolving environment and continued uncertainties resulting from the impact of COVID-19, Intersect ENT withdrew its annual guidance for 2020. Based on second quarter elective procedure volumes and referral trends, in addition to the strong third quarter start, the Company expects a sequential increase in revenues during the second half of 2020 from second quarter 2020 levels and to grow revenues in 2021 relative to 2019. The Company believes it will also return to gross margin levels in the mid-70% range by year end 2020. As a result of the Company's cost reduction initiatives and capital raise of $65.0 million announced in May, the Company continues to believe it has adequate capital to operate effectively through 2022.

    Non-GAAP Measures vs. GAAP Financial Measures

    This release contains financial measures that are not calculated in accordance with U.S. generally accepted accounting principles ("GAAP"). A reconciliation of the non-GAAP financial measures to the most directly comparable GAAP financial measures is provided in the financial schedules portion at the end of this press release. These non-GAAP financial measures differ from GAAP measures with the same captions and may differ from non-GAAP financial measures with the same or similar captions that are used by other companies. As such, these non-GAAP measures should not be considered substitutes for, or superior to, financial measures calculated in accordance with GAAP.

    The Company uses these non-GAAP financial measures to analyze its operating performance and future prospects, develop internal budgets and financial goals, and to facilitate period-to-period comparisons. The Company believes that these non-GAAP financial measures are useful to investors as they reflect an additional way of viewing aspects of its operations that, when viewed with its GAAP results, provide a more complete understanding of factors and trends affecting its business.

    Webcast and Conference Call Information

    Intersect ENT will host a conference call at 8:30 a.m. ET (5:30 a.m. PT) today to discuss the Company's second quarter 2020 results and business outlook. To access the conference call via the internet, go to the "Investor Relations" page of the Company's web site at www.intersectENT.com. To access the live conference call via phone, dial 844-850-0548 and ask to join the Intersect ENT call. International callers may access the live call by dialing 412-317-5205. Participants may expedite telephone access by pre-registering for the call using the following link: http://dpregister.com/10145790.

    A replay of the conference call may be accessed one to two hours after the call at www.intersectENT.com or via phone at 877-344-7529 or 412-317-0088 for international callers. The reference number to enter the replay of the call is 10145790. The dial-in replay will be available for a week after the call and via the internet for approximately one month.

    About Intersect ENT

    Intersect ENT is company transforming care for patients with ear, nose and throat conditions. The Company's steroid releasing implants are designed to provide mechanical spacing and deliver targeted therapy to the site of disease. In addition, Intersect ENT is continuing to expand its portfolio of products based on the Company's unique localized steroid releasing technology and is committed to broadening patient access to less invasive and more cost-effective care.

    For additional information on the Company or the products including risks and benefits please visit www.IntersectENT.com. For more information about PROPEL® (mometasone furoate) sinus implants and SINUVA® (mometasone furoate) sinus implant, please visit www.PROPELOPENS.com and www.SINUVA.com.

    Intersect ENT®, PROPEL® and SINUVA® are registered trademarks of Intersect ENT, Inc.

    Forward-Looking Statements

    The statements in this press release regarding Intersect ENT's expectations that continued increases in elective sinus procedures will drive sequential revenue growth during the second half of 2020, that gross margin will steadily improve in the second half of 2020 as and to the extent volume and production return to normal levels, and that it expects to achieve approximately $40.0 million in cash savings for the full-year 2020 from its cost reduction efforts, as well as the statements under the caption "Outlook," are "forward-looking" statements. These forward-looking statements are based on Intersect ENT's current expectations and inherently involve significant risks and uncertainties. These statements and risks include: the duration and severity of the COVID-19 pandemic is unknown and could continue, and be more severe than Intersect ENT currently expects; the unknown state of the U.S. economy following the pandemic; the level of demand for Intersect ENT's products as the pandemic subsides; the ability of Intersect ENT to effectively and efficiently resume full commercial and manufacturing operations; the time it will take for the economy to recover from the pandemic; and the sufficiency of capital to run the Company through 2022. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, and others which are described in the Company's latest Form 10-K and 10-Q filed with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov). Intersect ENT does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law.

    Intersect ENT, Inc.
    Condensed Consolidated Statements of Operations
    (in thousands, except percentages and per share data)
    (unaudited)
     
     

    Three Months Ended

     

    Six Months Ended

    June 30,

     

    June 30,

     

    2020

     

     

     

    2019

     

     

     

    2020

     

     

     

    2019

     

    Revenue

    $

    9,780

     

    $

    26,659

     

    $

    29,606

     

    $

    53,332

     

    Cost of sales

     

    7,357

     

     

    5,046

     

     

    13,767

     

     

    9,691

     

    Gross profit

     

    2,423

     

     

    21,613

     

     

    15,839

     

     

    43,641

     

    Gross margin

     

    25

    %

     

    81

    %

     

    53

    %

     

    82

    %

     
    Operating expenses:
    Selling, general and administrative

     

    19,497

     

     

    27,611

     

     

    45,697

     

     

    54,818

     

    Research and development

     

    4,018

     

     

    6,041

     

     

    9,164

     

     

    12,307

     

    Total operating expenses

     

    23,515

     

     

    33,652

     

     

    54,861

     

     

    67,125

     

    Loss from operations

     

    (21,092

    )

     

    (12,039

    )

     

    (39,022

    )

     

    (23,484

    )

    Interest expense

     

    (486

    )

     

    -

     

     

    (486

    )

     

    -

     

    Other income (expense), net

     

    (1,546

    )

     

    655

     

     

    (1,149

    )

     

    1,295

     

    Net loss

    $

    (23,124

    )

    $

    (11,384

    )

    $

    (40,657

    )

    $

    (22,189

    )

     
    Net loss per share, basic and diluted

    $

    (0.71

    )

    $

    (0.36

    )

    $

    (1.25

    )

    $

    (0.71

    )

     
    Weighted average common shares used to compute net loss per share, basic and diluted

     

    32,595

     

     

    31,362

     

     

    32,480

     

     

    31,141

     

     
    Intersect ENT, Inc.
    Condensed Consolidated Balance Sheets
    (in thousands)
    (unaudited)
     

    June 30,

    December 31,

    2020

    2019

    Assets
    Current assets:
    Cash, cash equivalents and short-term investments

    $ 135,831

    $ 90,638

    Accounts receivable, net

    7,653

    19,113

    Inventories, net

    14,007

    17,000

    Prepaid expenses and other current assets

    1,964

    2,300

    Total current assets

    159,455

    129,051

    Property and equipment, net

    5,893

    6,312

    Operating lease right-of-use assets

    10,901

    11,980

    Other non-current assets

    533

    559

    Total assets

    $ 176,782

    $ 147,902

     
    Liabilities and Stockholders' Equity
    Current liabilities:
    Accounts payable

    $ 2,616

    $ 4,056

    Accrued compensation

    8,077

    12,717

    Other current liabilities

    3,437

    2,163

    Total current liabilities

    14,130

    18,936

    Operating lease liabilities

    9,645

    10,886

    Convertible notes, net

    63,874

    -

    Other non-current liabilities

    22

    22

    Total liabilities

    87,671

    29,844

    Total stockholders' equity

    89,111

    118,058

    Total liabilities and stockholders' equity

    $ 176,782

    $ 147,902

     
    Intersect ENT, Inc.
    Reconciliation of Condensed Consolidated GAAP Financial Measures to Non-GAAP Financial Measures
    (in thousands, except per share data)
    (unaudited)
     
     
    Three Months Ended Six Months Ended
    June 30, June 30,

     

    2020

     

     

     

    2019

     

     

     

    2020

     

     

     

    2019

     

    Non-GAAP Net Loss
    Net Loss, as reported (GAAP)

    $

    (23,124

    )

    $

    (11,384

    )

    $

    (40,657

    )

    $

    (22,189

    )

    Loss on embedded derivatives

     

    1,796

     

     

    -

     

     

    1,796

     

     

    -

     

    Restructuring costs

     

    242

     

     

    -

     

     

    242

     

     

    -

     

    Adjusted Net Loss (non-GAAP)

    $

    (21,086

    )

    $

    (11,384

    )

    $

    (38,619

    )

    $

    (22,189

    )

     
    Basic and Diluted Net Loss per Share:
    Net Loss per share, as reported (GAAP)

    $

    (0.71

    )

    $

    (0.36

    )

    $

    (1.25

    )

    $

    (0.71

    )

    Adjusted Net Loss per share (non-GAAP)

    $

    (0.65

    )

    $

    (0.36

    )

    $

    (1.19

    )

    $

    (0.71

    )

     
    Shares used to compute GAAP and Non-GAAP Basic and Diluted Net Loss per Share

     

    32,595

     

     

    31,362

     

     

    32,480

     

     

    31,141

     

     
     
     

     

    View Full Article Hide Full Article
  4. Industry Veterans Will Lead Planned Launch of Device Designed to Provide a Safe, Rapid Solution for Abnormal Postpartum Uterine Bleeding

    Alydia Health, today announced that the company has raised $13.9 million in a Series C financing led by AXA Investment Managers through its Impact Investing Strategy. Existing investors including Global Health Investment Fund and Avestria Ventures also participated in the round.

    Proceeds will be used to support the anticipated U.S. commercial launch of the Jada® System, an innovative technology designed to rapidly control and treat postpartum hemorrhage (PPH), also known as abnormal postpartum uterine bleeding. Alydia recently completed the pivotal PEARLE IDE Study of the Jada System, and the results have…

    Industry Veterans Will Lead Planned Launch of Device Designed to Provide a Safe, Rapid Solution for Abnormal Postpartum Uterine Bleeding

    Alydia Health, today announced that the company has raised $13.9 million in a Series C financing led by AXA Investment Managers through its Impact Investing Strategy. Existing investors including Global Health Investment Fund and Avestria Ventures also participated in the round.

    Proceeds will be used to support the anticipated U.S. commercial launch of the Jada® System, an innovative technology designed to rapidly control and treat postpartum hemorrhage (PPH), also known as abnormal postpartum uterine bleeding. Alydia recently completed the pivotal PEARLE IDE Study of the Jada System, and the results have been submitted in a pending 510(k) submission to the U.S. Food and Drug Administration (FDA) for marketing clearance of the device.

    In association with the financing, Dr. Zina Affas Besse, Managing Partner at Global Health Funds will join the company's board of directors.

    "Alydia Health's device for postpartum hemorrhage has tremendous potential to improve outcomes for mothers and families around the world," said Jonathan Dean, Head of Impact Investing at AXA Investment Managers. "We are proud to invest in some of the most innovative technologies that address major public health issues worldwide, while generating attractive social and financial returns. Alydia's technology addresses both of these measures and we look forward to supporting the company through the upcoming launch of the Jada System."

    Rob Binney Joins as CEO, Colby Holtshouse Appointed COO

    The company also announced the appointment of seasoned medical device executive Robert Binney as Chief Executive Officer. Binney joins the company from Intersect ENT (NASDAQ:XENT), where he built a team of 200 employees and grew the company to over $100 million in annual revenue. As Chief Commercial Officer, Binney helped lead Intersect ENT from pre-FDA approval through a successful initial public offering and the launch of three products, while maintaining broad responsibility for the company's global commercial strategy and execution. Prior to Intersect ENT, Binney worked in leadership roles with both startups and large medical device companies, including Boston Scientific (NYSE:BSX) and AccessClosure, now part of Cardinal Health.

    "Alydia is poised to successfully address a serious condition that contributes significantly to maternal mortality in the United States and around the world, and I couldn't be more excited to join this team during this critical time in the company's evolution," said Binney. "I believe in the potential of this unique technology to fill a growing clinical need in postpartum care, and I look forward to leading the company through its next phase of commercialization. We are proud that this esteemed group of investors recognizes the enormous opportunity Alydia represents in transforming innovations in women's health."

    Binney succeeds Anne Morrissey, who recently stepped down as the company's CEO. Colby Holtshouse, previously Alydia's interim CEO and VP of Marketing, will assume the role of Chief Operating Officer, building on nearly two decades of experience in medical technology commercialization at industry pioneers such as Guidant, Medtronic and AccessClosure, as well as at several innovative medtech startups.

    "We are thrilled to have Rob leading the Alydia team. He has been instrumental in scaling up a number of commercial organizations and his experience bringing medical technologies to market in diverse and competitive environments will prove invaluable to the organization," said Curt LaBelle, Managing Partner at the Global Health Investment Fund and member of Alydia's Board of Directors. "On behalf of the Board, I want to thank Anne for her leadership in positioning Alydia for commercial success, and congratulate Colby on her promotion to COO and for leading the company through this critical time as interim CEO."

    About Alydia Health

    Alydia Health is a medical device company focused on preventing maternal morbidity and mortality caused by postpartum hemorrhage (PPH) and abnormal postpartum uterine bleeding – a challenging condition to manage and a growing problem in the U.S. and globally. PPH is one of the most common complications of birth, resulting in pharmacologic treatment in up to 10% of mothers1 and resulting in emergency intervention such as hysterectomy and expensive blood transfusions, and, in some cases, maternal death.

    Founded in 2010 with a vision to make childbirth safer for all mothers, Alydia's investigational device, the Jada System, is designed to work with the normal contraction of the uterus to rapidly stop excessive bleeding after childbirth. The company recently submitted a 510(k) submission to FDA for the marketing clearance of the Jada System based on results from the pivotal PEARLE IDE Study, which is now pending. For more information, visit www.alydiahealth.com and follow the company on Twitter at @AlydiaHealth and on LinkedIn at @Alydia Health.

    About AXA Investment Managers

    AXA Investment Managers (AXA IM) is an active, long-term, global, multi-asset investor. We work with clients today to provide the solutions they need to help build a better tomorrow for their investments, while creating a positive change for the world in which we all live. With approximately €804 billion in assets under management as at end of March 2020, AXA IM employs over 2,360 employees around the world and operates out of 28 offices across 20 countries. AXA IM is part of the AXA Group, a world leader in financial protection and wealth management.

    Visit our website: www.axa-im.com

    Follow us on Twitter: @AXAIM & @AXAIM_UK

    Follow us on LinkedIn: https://www.linkedin.com/company/axa-investment-managers

    Visit our media centre: www.axa-im.com/en/media-centre


    1 Widmer M et al. "Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth." N Engl J Med 2018; 379:743-752.

    View Full Article Hide Full Article
  5. Intersect ENT, Inc. (NASDAQ:XENT), a company transforming care for patients with ear, nose and throat ("ENT") conditions, today announced that it will release second quarter 2020 financial results on August 4, 2020. The Company expects to issue the release at approximately 7:00 a.m. ET and management will host a conference call at 8:30 a.m. ET.

    To access the conference call via the internet, go to the "Investor Relations" page of the Company's website at www.intersectENT.com. To access the live conference call via phone, dial 844-850-0548 and ask to join the Intersect ENT call. International callers may access the live call by dialing 412-317-5205. Participants may expedite telephone access by pre-registering for the call using the following…

    Intersect ENT, Inc. (NASDAQ:XENT), a company transforming care for patients with ear, nose and throat ("ENT") conditions, today announced that it will release second quarter 2020 financial results on August 4, 2020. The Company expects to issue the release at approximately 7:00 a.m. ET and management will host a conference call at 8:30 a.m. ET.

    To access the conference call via the internet, go to the "Investor Relations" page of the Company's website at www.intersectENT.com. To access the live conference call via phone, dial 844-850-0548 and ask to join the Intersect ENT call. International callers may access the live call by dialing 412-317-5205. Participants may expedite telephone access by pre-registering for the call using the following link: http://dpregister.com/10145790.

    A replay of the conference call may be accessed one to two hours after the call at www.intersectENT.com or via phone at 877-344-7529 or 412-317-0088 for international callers. The reference number to enter the replay of the call is 10145790. The dial-in replay will be available for a week after the call, and via the internet for approximately one month.

    About Intersect ENT

    Intersect ENT is dedicated to transforming ear, nose and throat care by providing innovative, clinically meaningful therapies to physicians and patients. The Company's steroid-releasing implants are designed to provide mechanical spacing and deliver targeted therapy to the site of disease. In addition, Intersect ENT is continuing to expand its portfolio of products based on the Company's unique localized steroid releasing technology and is committed to broadening patient access to less invasive and more cost-effective care.

    For additional information on the Company or the products including risks and benefits please visit www.IntersectENT.com. For more information about PROPEL® (mometasone furoate) sinus implants and SINUVA® (mometasone furoate) sinus implant, please visit www.PROPELOPENS.com and www.SINUVA.com.

    Intersect ENT®, PROPEL® and SINUVA® are registered trademarks of Intersect ENT, Inc.

    XENT-F

    View Full Article Hide Full Article
View All Intersect ENT Inc. News