ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
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(Address of principal executive offices) |
(zip code) |
Title of Each Class |
Trading Symbol |
Name of Exchange on Which Registered | ||
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☑ |
Accelerated filer |
☐ | |||||
Non-accelerated filer |
☐ |
Smaller reporting company |
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Emerging growth company |
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Item 1. |
1 |
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Item 1A. |
19 |
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Item 1B. |
51 |
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Item 2. |
52 |
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Item 3. |
52 |
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Item 4. |
52 |
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Item 5. |
53 |
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Item 6. |
55 |
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Item 7. |
56 |
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Item 7A. |
65 |
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Item 8. |
65 |
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Item 9. |
65 |
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Item 9A. |
66 |
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Item 9B. |
69 |
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Item 10. |
69 |
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Item 11. |
69 |
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Item 12. |
69 |
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Item 13. |
69 |
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Item 14. |
70 |
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Item 15. |
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Item 16. |
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76 |
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F- 1 |
Item 1. |
Business |
• | PROPEL is a self-expanding implant designed to conform to and hold open the surgically enlarged sinus while gradually releasing an anti-inflammatory steroid over a period of approximately 30 days and is absorbed into the body over a period of approximately six weeks. PROPEL clinical outcomes have been reported in a meta-analysis of prospective, multicenter, randomized, controlled, double-blind clinical studies to improve surgical outcomes, demonstrating a 35% relative reduction in the need for postoperative interventions compared to surgery alone. A physician may treat a patient with PROPEL by inserting it into the ethmoid sinuses following ethmoid sinus surgery. |
• | PROPEL Mini is a smaller version of PROPEL and is approved for use in both the ethmoid and frontal sinuses. PROPEL Mini is preferentially used by physicians compared with PROPEL when treating smaller anatomies or following less extensive procedures. PROPEL Mini has also been shown by our clinical studies to reduce the need for postoperative interventions, including a 38% relative reduction in the need for postoperative interventions in the frontal sinus, compared to surgery alone with standard postoperative care. |
• | PROPEL Contour is designed to facilitate treatment of the frontal and maxillary sinus ostia, or openings, of the dependent sinuses in procedures performed in both the operating room and in the office setting of care. PROPEL Contour’s lower profile, hourglass shape and malleable delivery system are designed for use in the narrow and difficult to access sinus ostia. In PROPEL Contour’s pivotal clinical study, the product demonstrated a 65% relative reduction in the need for postoperative interventions in the frontal sinus ostia compared to surgery alone with standard postoperative care. |
• | Limited effectiveness. |
• | Limited ability to address postoperative inflammation. |
• | Pain and discomfort during postoperative period. |
• | Potential for revision surgery. |
• | Improved surgical outcomes. |
• | Targeted steroid therapy to address postoperative inflammation. |
• | Improved healing without obstruction. |
• | Reduced need for postoperative surgical interventions. 80-patient prospective, randomized, blinded, multicenter trial of PROPEL Contour, demonstrated a statistically significant 65% relative reduction in the need for postoperative interventions compared to surgery alone when PROPEL Contour was placed in the frontal sinus. We believe that patients who have been deterred by the high revision rates associated with FESS may now consider surgical intervention to treat their chronic sinusitis condition. |
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Principal Efficacy Results at Day 30 as graded by independent, blinded panel of physicians |
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Outcome Measure |
Evaluable Patients* |
Treatment Sides (n=143) No. (%) |
Control Sides (n=143) No. (%) |
Relative Reduction (%) |
P Value |
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Postoperative intervention |
128 |
42 (32.8) |
65 (50.8) |
-35 |
0.0008 |
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Adhesion lysis |
134 |
19 (14.2) |
39 (29.1) |
-51 |
0.0016 |
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Oral steroid intervention |
113 |
25 (22.1) |
42 (37.2) |
-40 |
0.0023 |
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Frank polyposis |
111 |
22 (19.8) |
41 (36.9) |
-46 |
<0.0001 |
* | Evaluable subjects were those with gradable sinuses on both sides |
• | greater financial and human capital resources; |
• | significantly greater name recognition; |
• | established relationships with ENT physicians, referring physicians, customers and third-party payors; |
• | additional lines of products, and the ability to offer rebates or bundle products to offer greater discounts or incentives to gain a competitive advantage; and |
• | established sales, marketing and worldwide distribution networks. |
• | successfully expanding our commercial operations; |
• | continuing to innovate and maintain scientifically-advanced technology; |
• | having reimbursement in place to support broad adoption of our products; |
• | developing technologies for applications in the sinuses and other areas of ENT; |
• | attracting and retaining skilled personnel; |
• | obtaining patents or other intellectual property protection for our products; and |
• | conducting clinical studies and obtaining and maintaining regulatory approvals. |
• | preclinical laboratory tests and animal tests conducted under Good Laboratory Practices, or GLP; |
• | submission to the FDA of an Investigational New Drug, or IND, application for human clinical testing, which must become effective before human clinical trials commence; |
• | adequate and well-controlled human clinical trials to establish the safety and efficacy of the product and conducted in accordance with Good Clinical Practices, or GCP; |
• | the submission to the FDA of an NDA; |
• | FDA acceptance, review and approval of the NDA; and |
• | satisfactory completion of an FDA inspection of the manufacturing facilities at which the product is made to assess compliance with current Good Manufacturing Practices, or cGMPs. |
Item 1A. |
Risk Factors |
• | lack of experience with our products; |
• | lack of adequate reimbursement or cost to the patient; |
• | lack of conviction regarding evidence supporting cost benefits or cost effectiveness of our products over existing alternatives; |
• | lack of clinical data supporting longer-term patient benefits or, in the case of SINUVA, repeated use; |
• | new technologies that may be competitive to our products; and |
• | liability risks generally associated with the use of new products and procedures. |
• | payors adoption of positive medical policies covering SINUVA or including SINUVA on their formularies; |
• | payors providing product reimbursement; |
• | physicians being able to secure payment for their time through appropriate procedural codes; |
• | patients’ willingness to make any required co-pay or co-insurance payments; and |
• | physician’s willingness to purchase the product directly and seek reimbursement from payors and patient co-pay for that expense, as is required by some payors. Such payments may or may not be received by the physician or may not fully cover the cost of the product. |
• | regulatory authorities may withdraw their approval of SINUVA or impose restrictions on its distribution; |
• | regulatory authorities may require the addition of labeling statements, such as warnings or contraindications; |
• | we may be required to change the way SINUVA is promoted or administered, or conduct additional clinical studies; |
• | we could be sued and held liable for harm caused to patients; or |
• | our reputation may suffer. |
• | not provide us accurate or timely information regarding their inventories, the number of patients who are using our products or complaints about our products; |
• | reduce or discontinue their efforts to sell or support or otherwise not effectively sell or support our products; |
• | not devote the resources necessary to sell our products in the volumes and within the time frames that we expect; |
• | engage in unlawful or inappropriate business practices that result in legal or regulatory enforcement activity which could result in liability to the Company or damage its goodwill with customers; or |
• | be unable to satisfy financial obligations to us or others. |
• | ENT physician adoption of our steroid releasing implants; |
• | ENT physician willingness to engage in the buy and bill process for SINUVA implants; |
• | fluctuations in revenue due to changes in or from estimated gross-to-net deductions, including distributor fees and prompt payment discounts, discounts related to commercial agreements or government mandated programs, returns and replacements and, should we elect to offer such support, patient or payor assistance programs, and other related deductions and adjustments; |
• | unanticipated pricing pressure; |
• | the hiring, retention and continued productivity of our sales representatives; |
• | our ability to expand the geographic reach of our sales and marketing efforts, including into the UK and the EU in light of regulatory and geopolitical uncertainties arising from Brexit and the new European Medical Device Regulation (MDR); |
• | our ability to obtain or maintain regulatory approval and reimbursement coverage for our products in development or for our current products outside the United States; |
• | fluctuations in revenue due to changes in third-party payor reimbursement for procedures associated with the use of our products; |
• | our ability to maintain intellectual property protection for our products and our competitors being granted patents for competing products; |
• | results of clinical research and trials on our existing products and products in development; |
• | delays in receipt of anticipated purchase orders; |
• | timing of new product offerings, acquisitions, licenses or other significant events by us or our competitors; |
• | delays in, failure of, or quality issues with, component and raw material deliveries by our suppliers or service providers; |
• | manufacturing issues or lot failures; and |
• | positive or negative coverage in the media or clinical publications of our steroid releasing implants or products of our competitors or our industry. |
• | properly identify and anticipate ENT physician and patient needs; |
• | receive adequate reimbursement for such products; |
• | develop and introduce new products or product enhancements in a timely manner; |
• | avoid infringing upon the intellectual property rights of third parties; |
• | demonstrate, if required, the safety and efficacy of new products with data from preclinical studies and clinical trials; |
• | obtain the necessary regulatory clearances or approvals for new products or product enhancements; |
• | be fully FDA-compliant with marketing and manufacturing of new devices or modified products; |
• | provide adequate training to potential users of our products; and |
• | develop an effective and FDA-compliant, dedicated sales and marketing team. |
• | greater financial and human capital resources; |
• | significantly greater name recognition; |
• | established relationships with ENT physicians, referring physicians, customers and third-party payors; |
• | additional lines of products, and the ability to offer rebates or bundle products to offer greater discounts or incentives to gain a competitive advantage; and |
• | established sales, marketing and worldwide distribution networks. |
• | costs of litigation; |
• | distraction of management’s attention from our primary business; |
• | the inability to commercialize our products or, if approved, our product candidates; |
• | decreased demand for our products or, if approved, product candidates; |
• | impairment of our business reputation; |
• | product recall or withdrawal from the market; |
• | withdrawal of clinical trial participants; |
• | substantial monetary awards to patients or other claimants; or |
• | loss of revenue. |
• | the FDA, institutional review boards or other regulatory authorities do not approve a clinical study protocol, force us to modify a previously approved protocol, or place a clinical study on hold; |
• | patients do not enroll in, or enroll at a lower rate than we expect, or do not complete a clinical study; |
• | patients or investigators do not comply with study protocols; |
• | patients do not return for post-treatment follow-up at the expected rate; |
• | patients experience unexpected adverse event or side effects for a variety of reasons that may or may not be related to our products; |
• | sites participating in an ongoing clinical study withdraw, requiring us to engage new sites; |
• | difficulties or delays associated with establishing additional clinical sites; |
• | third-party clinical investigators decline to participate in our clinical studies, do not perform the clinical studies on the anticipated schedule, or are inconsistent with the investigator agreement, clinical study protocol, good clinical practices or other agency requirements; |
• | third-party organizations do not perform data collection and analysis in a timely or accurate manner; |
• | regulatory inspections of our clinical studies or manufacturing facilities require us to undertake corrective action or suspend or terminate our clinical studies; |
• | changes in federal, state, or foreign governmental statutes, regulations or policies; |
• | interim results are inconclusive or unfavorable as to immediate and long-term safety or efficacy; |
• | the study design is inadequate to demonstrate safety and efficacy; or |
• | the study does not meet the primary endpoints. |
• | changes in customer, geographic, or product mix; |
• | introduction of new products, which may have lower margins than our existing products; |
• | our ability to maintain or reduce production costs; |
• | changes to our pricing strategy; |
• | changes in competition; |
• | changes in production volume driven by demand for our products; |
• | changes in material, labor, or other manufacturing-related costs; |
• | changes to U.S. and foreign trade policies, such as the enactment of tariffs on goods imported into the United States; |
• | manufacturing issues, lot failures, inventory obsolescence and product recall charges; and |
• | market conditions. |
• | adverse publicity, warning letters, fines, injunctions, consent decrees and civil penalties; |
• | repair, replacement, recall or seizure of our products; |
• | operating restrictions or partial suspension or total shutdown of production; |
• | delaying or refusing our requests for approval of new products, new intended uses or modifications to our existing products; |
• | refusal to grant export approval for our products; |
• | withdrawing product approvals that have already been granted; and |
• | criminal prosecution. |
• | we may be unable to demonstrate to the satisfaction of regulatory authorities that a product candidate is safe and effective for any indication; |
• | regulatory authorities may not find the data from clinical studies sufficient or may differ in the interpretation of the data; |
• | regulatory authorities may require additional clinical studies; |
• | the FDA or foreign regulatory authority might not approve our manufacturing processes or facilities for clinical or commercial production; |
• | the FDA or foreign regulatory authority may change its approval policies or adopt new regulations; |
• | the FDA or foreign regulatory authorities may disagree with the design or implementation of our clinical studies; |
• | the FDA or foreign regulatory authority may not accept clinical data from studies that are conducted in countries where the standard of care is potentially different from that in the United States; |
• | the results of clinical studies may not meet the level of statistical significance required by the FDA or foreign regulatory authorities for approval; |
• | we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; and |
• | the data collection from clinical studies of our product candidates may not be sufficient to support the submission of a NDA or other submission or to obtain regulatory approval in the United States or elsewhere. |
• | untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; |
• | unanticipated expenditures to address or defend such actions; |
• | customer notifications or repair, replacement, refunds, recall, detention or seizure of our products; |
• | operating restrictions, partial suspension or total shutdown of production; |
• | refusing or delaying our requests for regulatory approvals of new products or modified products; |
• | withdrawing PMA or NDA approvals that have already been granted; |
• | refusal to grant export approval for our products; or |
• | criminal prosecution. |
• | the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering, or paying remuneration, directly or indirectly, in cash or in kind, in exchange for or to induce either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare and Medicaid; |
• | the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from federal health care programs, such as Medicare and Medicaid that are false or fraudulent; knowingly making, using, or causing to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the government; or knowingly making, using, or causing to be made or used, a false record or statement to avoid, decrease or conceal an obligation to pay money to the federal government; |
• | the federal criminal False Claims Act, which imposes criminal fines or imprisonment against individuals or entities who make or present a claim to the government knowing such claim to be false, fictitious or fraudulent; |
• | the civil monetary penalties statute, which imposes penalties against any person or entity who, among other things, is determined to have presented or caused to be presented, a claim to a federal healthcare program that the person knows, or should know, is for an item or service that was not provided as claimed or is false or fraudulent; |
• | the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended, which created federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans and healthcare clearinghouses as well as their business associates that perform services for them that involve individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization, including mandatory contractual terms as well as directly applicable privacy and security standards and requirements, as well as comparable international privacy laws (e.g. the European Union’s General Data Protection Regulation, or GDPR), or localized privacy laws (e.g. the California Consumer Privacy Act of 2018, effective beginning January 2020, mirroring a number of the key provisions in the GDPR); |
• | the Federal Trade Commission Act and similar laws regulating advertisement and consumer protections; |
• | the federal Foreign Corrupt Practices Act of 1997, which prohibits corrupt payments, gifts or transfers of value to foreign officials; and |
• | foreign or U.S. state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers. |
• | imposes an annual excise tax of 2.3% on any entity that manufactures or imports medical devices offered for sale in the United States beginning in 2013; |
• | establishes a new Patient-Centered Outcomes Research Institute to oversee and identify priorities in comparative clinical effectiveness research in an effort to coordinate and develop such research; and |
• | implements payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality and efficiency of certain healthcare services through bundled payment models. |
• | expand the commercialization of our products; |
• | fund our operations and clinical studies; |
• | continue our research and development activities; |
• | defend, in litigation or otherwise, any claims that we infringe third-party patents or other intellectual property rights; |
• | enforce our patent and other intellectual property rights; |
• | address legal or enforcement actions by the FDA or other governmental agencies and remediate underlying problems; |
• | commercialize our new products in development, if any such products receive regulatory clearance or approval for commercial sale; and |
• | acquire companies and in-license products or intellectual property. |
• | market acceptance of our products, including access to adequate reimbursement; |
• | the cost of our research and development activities, including clinical studies; |
• | the cost of filing and prosecuting patent applications and defending and enforcing our patent or other intellectual property rights; |
• | the cost of defending, in litigation or otherwise, any claims that we infringe third-party patents or other intellectual property rights; |
• | the cost and timing of additional regulatory clearances or approvals; |
• | the cost and timing of growing sales, marketing and distribution capabilities; |
• | costs associated with any product recall that may occur; |
• | the effect of competing technological and market developments; |
• | the extent to which we acquire or invest in products, technologies and businesses, although we currently have no commitments or agreements relating to any of these types of transactions; and |
• | the costs of operating as a public company. |
• | volume and timing of sales of our steroid releasing implants; |
• | changes in reimbursement or in coverage by commercial payors related to our products; |
• | changes in governmental regulations or in the status of our regulatory approvals or applications; |
• | the introduction of new products or product enhancements by us or others in our industry; |
• | disputes or other developments with respect to our or others’ intellectual property rights; |
• | our ability to develop, obtain regulatory clearance or approval for, and market new and enhanced products on a timely basis; |
• | product liability claims or other litigation; |
• | quarterly variations in our results of operations or those of others in our industry; |
• | sales of large blocks of our common stock, including sales by our executive officers and directors; |
• | media exposure of our steroid releasing implants or products of others in our industry; |
• | changes in earnings estimates or recommendations by securities analysts; and |
• | general market conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors. |
• | faulty human judgment and simple errors, omissions or mistakes; |
• | fraudulent action of an individual or collusion of two or more people; |
• | inappropriate management override of procedures; and |
• | the possibility that any enhancements to controls and procedures may still not be adequate to assure timely and accurate financial control. |
• | our board of directors has the right to expand the size of our board of directors and to elect directors to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors; |
• | our stockholders may not act by written consent or call special stockholders’ meetings; as a result, a holder, or holders, controlling a majority of our capital stock would not be able to take certain actions other than at annual stockholders’ meetings or special stockholders’ meetings called by the board of directors, the chairman of the board, the chief executive officer or the president; |
• | our certificate of incorporation prohibits cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates; |
• | the affirmative vote of holders of at least 66-2/3% of the voting power of all of the then outstanding shares of voting stock, voting as a single class, will be required (a) to amend certain provisions of our certificate of incorporation, including provisions relating to the size of the board, removal of directors, special meetings, actions by written consent and cumulative voting and (b) to amend or repeal our bylaws, although our bylaws may be amended by a simple majority vote of our board of directors; |
• | stockholders must provide advance notice and additional disclosures in order to nominate individuals for election to the board of directors or to propose matters that can be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquiror from conducting a solicitation of proxies to elect the acquiror’s own slate of directors or otherwise attempting to obtain control of our company; and |
• | our board of directors may issue, without stockholder approval, shares of undesignated preferred stock; the ability to issue undesignated preferred stock makes it possible for our board of directors to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to acquire us. |
Item 1B. |
Unresolved Staff Comments |
Item 2. |
Properties |
Item 3. |
Legal Proceedings |
Item 4. |
Mine Safety Disclosures |
Item 5. |
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities |
Cumulative Total Return as of |
||||||||||||||||||||||||
12/31/14 |
12/31/15 |
12/31/16 |
12/31/17 |
12/31/18 |
12/31/19 |
|||||||||||||||||||
Intersect ENT, Inc. |
100.00 |
121.29 |
65.23 |
174.66 |
151.91 |
134.23 |
||||||||||||||||||
NASDAQ Composite Index |
100.00 |
105.73 |
113.66 |
145.76 |
140.10 |
189.45 |
||||||||||||||||||
NASDAQ Biotechnology Index |
100.00 |
111.42 |
87.26 |
105.64 |
95.79 |
119.17 |
Item 6. |
Selected Financial Data |
Fiscal Years Ended December 31, |
||||||||||||||||||||
(in thousands, except per share data) |
2019 |
2018 |
2017 |
2016 |
2015 |
|||||||||||||||
Consolidated statements of operations data: |
||||||||||||||||||||
Revenue |
$ | 109,142 |
$ | 108,472 |
$ | 96,301 |
$ | 78,708 |
$ | 61,593 |
||||||||||
Cost of sales |
21,773 |
22,613 |
15,499 |
13,003 |
12,288 |
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Gross profit |
87,369 |
85,859 |
80,802 |
65,705 |
49,305 |
|||||||||||||||
Operating expenses: |
||||||||||||||||||||
Selling, general and administrative |
108,480 |
91,603 |
80,045 |
72,926 |
59,637 |
|||||||||||||||
Research and development |
24,283 |
19,262 |
18,360 |
18,890 |
16,608 |
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total operating expenses |
132,763 |
110,865 |
98,405 |
91,816 |
76,245 |
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Loss from operations |
(45,394 |
) | (25,006 |
) | (17,603 |
) | (26,111 |
) | (26,940 |
) | ||||||||||
Interest and other income, net |
2,400 |
2,084 |
1,240 |
889 |
306 |
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Net loss |
$ | (42,994 |
) | $ | (22,922 |
) | $ | (16,363 |
) | $ | (25,222 |
) | $ | (26,634 |
) | |||||
Net loss per share, basic and diluted |
$ | (1.37 |
) | $ | (0.76 |
) | $ | (0.56 |
) | $ | (0.89 |
) | $ | (1.02 |
) | |||||
Weighted average common shares used to compute net loss per share, basic and diluted |
31,388 |
30,313 |
29,119 |
28,420 |
26,159 |
|||||||||||||||
December 31, |
||||||||||||||||||||
(in thousands) |
2019 |
2018 |
2017 |
2016 |
2015 |
|||||||||||||||
Consolidated balance sheet data: |
||||||||||||||||||||
Cash, cash equivalents and short-term investments |
$ | 90,638 |
$ | 100,773 |
$ | 102,320 |
$ | 103,945 |
$ | 124,300 |
||||||||||
Working capital |
110,115 |
114,937 |
112,614 |
110,928 |
128,142 |
|||||||||||||||
Total assets |
147,902 |
140,961 |
135,575 |
129,777 |
144,635 |
|||||||||||||||
Total liabilities |
29,844 |
19,967 |
18,356 |
15,380 |
14,404 |
|||||||||||||||
Accumulated deficit |
(230,756 |
) | (187,762 |
) | (164,840 |
) | (148,477 |
) | (123,255 |
) | ||||||||||
Total stockholders’ equity |
118,058 |
120,994 |
117,219 |
114,397 |
130,231 |
Item 7. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
• | PROPEL is a self-expanding implant designed to conform to and hold open the surgically enlarged sinus while gradually releasing an anti-inflammatory steroid over a period of approximately 30 days and is absorbed into the body over a period of approximately six weeks. PROPEL clinical outcomes have been reported in a meta-analysis of prospective, multicenter, randomized, controlled, double-blind clinical studies to improve surgical outcomes, demonstrating a 35% relative reduction in the need for postoperative interventions compared to surgery alone. A physician may treat a patient with PROPEL by inserting it into the ethmoid sinuses. |
• | PROPEL Mini is a smaller version of PROPEL and is approved for use in both the ethmoid and frontal sinuses. PROPEL Mini is preferentially used by physicians compared with PROPEL when treating smaller anatomies or following less extensive procedures. PROPEL Mini has also been shown by our clinical studies to reduce the need for postoperative interventions, including a 38% relative reduction in the need for postoperative interventions in the frontal sinus, compared to surgery alone with standard postoperative care. |
• | PROPEL Contour is designed to facilitate treatment of the frontal and maxillary sinus ostia, or openings, of the dependent sinuses in procedures performed in both the operating room and in the |
office setting of care. PROPEL Contour’s lower profile, hourglass shape and malleable delivery system are designed for use in the narrow and difficult to access sinus ostia. In PROPEL Contour’s pivotal clinical study, the product demonstrated a 65% relative reduction in the need for postoperative interventions in the frontal sinus ostia compared to surgery alone with standard postoperative care. |
Fiscal Years Ended December 31, |
||||||||||||
(in thousands, except percentages) |
2019 |
2018 |
2017 |
|||||||||
Revenue |
$ | 109,142 |
$ | 108,472 |
$ | 96,301 |
||||||
Cost of sales |
21,773 |
22,613 |
15,499 |
|||||||||
|
|
|
|
|
|
|||||||
Gross profit |
87,369 |
85,859 |
80,802 |
|||||||||
Gross margin |
80 |
% |
79 |
% |
84 |
% | ||||||
Operating expenses: |
||||||||||||
Selling, general and administrative |
108,480 |
91,603 |
80,045 |
|||||||||
Research and development |
24,283 |
19,262 |
18,360 |
|||||||||
|
|
|
|
|
|
|||||||
Total operating expenses |
132,763 |
110,865 |
98,405 |
|||||||||
|
|
|
|
|
|
|||||||
Loss from operations |
(45,394 |
) | (25,006 |
) | (17,603 |
) | ||||||
Interest income and other, net |
2,400 |
2,084 |
1,240 |
|||||||||
|
|
|
|
|
|
|||||||
Net loss |
$ | (42,994 |
) | $ | (22,922 |
) | $ | (16,363 |
) | |||
(in thousands, except percentages) |
2019 |
2018 |
Change $ 2019 to 2018 |
Change % 2019 to 2018 |
||||||||||||
PROPEL family of products |
$ | 104,657 |
$ | 105,711 |
$ | (1,054 |
) | (1 |
)% | |||||||
SINUVA |
4,485 |
2,761 |
1,724 |
62 |
% | |||||||||||
|
|
|
|
|
|
|||||||||||
$ | 109,142 |
$ | 108,472 |
$ | 670 |
1 |
% | |||||||||
(in thousands, except percentages) |
2018 |
2017 |
Change $ 2018 to 2017 |
Change % 2018 to 2017 |
||||||||||||
PROPEL family of products |
$ | 105,711 |
$ | 96,301 |
$ | 9,410 |
10 |
% | ||||||||
SINUVA |
2,761 |
|