UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 10, 2020
TELA Bio, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 3841 | 45-5320061 | ||
|
(State or other jurisdiction of incorporation or organization) |
(Primary Standard Industrial Classification Code Number) |
(I.R.S. Employer Identification No.) |
|
1 Great Valley Parkway, Suite 24, Malvern, |
19355 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (484) 320-2930
Not Applicable
(Former name or former address, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol | Name of Exchange on Which Registered | ||
| Common Stock, par value $0.001 per share | TELA | Nasdaq Global Market |
Securities registered pursuant to Section 12(g) of the Act:
None
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 2.02 | Results of Operations and Financial Condition |
On January 10, 2020, TELA Bio, Inc. (the “Company”) issued a press release announcing its preliminary unaudited revenue for the fourth quarter and full-year ended December 31, 2019. A copy of this press release is furnished as Exhibit 99.1 hereto and incorporated herein by reference. In addition, slide 23 of the corporate slide deck attached as Exhibit 99.2 is incorporated herein by reference.
| Item 7.01 | Regulation FD Disclosure. |
During the week of January 13, 2020, representatives of the Company will be attending meetings with investors, analysts and others at the J.P. Morgan Healthcare Conference in San Francisco, California and these representatives of the Company plan to present the slides attached as Exhibit 99.2 to this Current Report on Form 8-K.
The information furnished pursuant to Item 2.02 and Item 7.01, including Exhibit 99.1 and Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
The following exhibits are being filed herewith:
|
Exhibit |
Document | |
| 99.1 | Press Release of TELA Bio, Inc. | |
| 99.2 | Corporate slide deck, dated January 2020 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| TELA BIO, INC. | ||
| By: | /s/ Antony Koblish | |
| Name: | Antony Koblish | |
| Title: | President, Chief Executive Officer and Director | |
Date: January 10, 2020
Exhibit 99.1
TELA Bio Announces Preliminary Revenue for Fourth Quarter and Full Year 2019
| - | Preliminary fourth quarter 2019 revenue increased 94%-102% year-over-year to $4.7 million to $4.9 million |
| - | Preliminary full year 2019 revenue increased 85%-87% year-over-year to $15.3 million to $15.5 million |
MALVERN, Pa., January 10, 2020 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (“TELA”) (Nasdaq: TELA), a commercial stage medical technology company focused on designing, developing and marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction, today announces unaudited preliminary revenue for the fourth quarter and full year 2019.
The company expects reported revenue for the fourth quarter of 2019 to be $4.7 million to $4.9 million, an increase of 94%-102% compared to $2.4 million in the fourth quarter of 2018. The company expects reported revenue for the full year of 2019 to be $15.3 million to $15.5 million, an increase of 85%-87% compared to $8.3 million for the full year of 2018. These strong results in the fourth quarter and full year 2019 were driven by expansion of the commercial organization, increased penetration within existing customer accounts, as well as the introduction of larger sizes of OviTex during 2019.
The Company expects reported cash, cash equivalents and short-term investments to be approximately $54.6 million at December 31, 2019.
“I am pleased with our fourth quarter results as well as the progress we made in 2019 to drive adoption of our OviTex and OviTex PRS product lines,” said Antony Koblish, co-founder, President and Chief Executive Officer of TELA Bio. “We intend to build on this momentum in 2020 as we continue to expand our commercial team, focus on implementation of our GPO contracts, increase our marketing activities, and drive operational excellence.”
The company has not yet completed closing its books for the fourth quarter or full year 2019, and the preliminary revenue and cash amounts for the fourth quarter and full year 2019 set forth in this press release represent the most current information available to management and reflect estimates and assumptions. This financial information is preliminary, unaudited and subject to adjustments. It does not present all information necessary to understanding the company’s fourth quarter and full-year financials results for 2019. Due to the completion of the company’s financial closing and review process, as well as the audit process, and other developments that may arise between the date of this press release and the time that financial results for the fourth quarter and full year 2019 are finalized, the company’s actual results may differ from these preliminary results and such differences may be material.
The company will report its final, audited fourth quarter and full year 2019 financial results during a conference call in March 2019. A press release with the date, time and webcast information will be provided closer to the reporting date. Financial guidance for 2020 will be provided on the company's fourth quarter and full year results conference call.
About TELA Bio, Inc.
TELA Bio, Inc. is a commercial stage medical technology company focused on designing, developing and marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction. TELA’s products are designed to improve on shortcomings of existing biologics and minimize long-term exposure to permanent synthetic material. TELA's portfolio is supported by quality, data-driven science and extensive pre-clinical research that has consistently demonstrated advantages over other commercially available products.
Caution Regarding Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such statements include statements regarding TELA’s expected revenue for the quarter and year ended December 31, 2019, its anticipated revenue trends and other statements that are not historical facts. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements and reflect the current beliefs of TELA’s management. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differs materially and adversely from those indicated by such forward-looking statements including, among others: our ability to gain market acceptance for our products and to accurately forecast customer demand, our ability to enhance our product offerings, development and manufacturing problems, capacity constraints or delays in production of our products. These and other risks and uncertainties are described more fully in the “Risk Factors” section and elsewhere in our filings with the with the Securities and Exchange Commission and available at www.sec.gov, including in our prospectus dated November 7, 2019. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and TELA assumes no obligation to updates forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.
| TELA Bio Contact |
| Stuart Henderson |
| Vice President, Corporate Development and Investor Relations |
| TELA Bio, Inc. |
| 484-320-2930 |
| shenderson@telabio.com |
| Investor Contact |
| Peter Vozzo |
| Westwicke |
| 443-213-0505 |
| peter.vozzo@westwicke.com |
Exhibit 99.2
1 TELA Bio: Advancing Soft Tissue Reconstruction January 2020
2 Forward Looking Statements This presentation contains forward - looking statements. All statements other than statements of historical facts contained in thi s document, including but not limited to statements regarding possible or assumed future results of operations, business strategies, development plans, regulatory activities, ma rke t opportunity competitive position, potential growth opportunities, and the effects of competition, are forward - looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause TELA Bio, Inc.’s (the “Company”) actual results, performance or achievements to be materially different from any future re sults, performance or achievements expressed or implied by the forward - looking statements. In some cases, you can identify forward - looking statements by terms such as “may,” “w ill,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the neg ati ve of these terms or other similar expressions. The forward - looking statements in this presentation are only predictions. The Company has based these forward - looking statements largely on its current expectations and projections about future events and financial trends that it believes may affect the Company’s business, financial condition and results of operations . T hese forward - looking statements speak only as of the date of this presentation and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predic ted or quantified and some of which are beyond the Company’s control. You should not rely on these forward - looking statements as predictions of future events. The events and circu mstances reflected in the Company’s forward - looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward - looking statements. Moreover, the Company operates in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for man age ment to predict all risk factors and uncertainties that the Company may face. Important factors that could cause actual results to differ from those in the forward - looking statements i nclude the factors described in the Company’s filings with the United States Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly upd ate or revise any forward - looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
3 A commercial stage medical technology company marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction ▫ Differentiated portfolio of advanced reinforced tissue matrices addressing hernia repair, abdominal wall reconstruction and plastic and reconstructive surgery ▫ Headquartered: Malvern, Pennsylvania ▫ Founded: 2012 TELA Bio Snapshot 1. Management estimate. $2B total equals $1.5B hernia & abdominal wall reconstruction and $0.5B plastic reconstructive surg ery . ~$2B U.S Market Opportunity 1 Innovative Products Reduce Overall Costs of Care Improve Clinical Outcomes
4 OviTex: ~$1.5 Billion Annual U.S. Total Addressable Hernia Market Opportunity Source: Millennium Research Group Reports, IMS Health Data 1) Management estimate. Market size based volume weighted average selling price for OviTex ~$650 million US market (1) ~711,000 total procedures per year ~$500 million US market (1) ~326,000 total procedures per year ~$350 million US market (1) ~58,000 total procedures per year Simple Ventral Hernia Repair Complex, Moderate Ventral / Abdominal Wall Reconstruction Inguinal Hernia Repair OviTex ~$1.5 Billion TAM Opportunity ~$40 million US market (1) ~40,000 total procedures per year Hiatal Hernia Repair
5 What is a hernia? ▫ Occurs when an internal part of the body pushes through a weakness or hole in the muscle or surrounding tissue ▫ Natural occurring weakness ▫ Weakness from previous surgical incision ▫ Likelihood of developing a hernia increases with age & obesity Treating a hernia ▫ Surgical repair of a hernia with a reinforcing material (mesh) is standard of care ▫ ~90% of hernia patients receive a mesh repair 1 ▫ Mesh intended to reinforce the defect and provide long - term support Hernias Occur Throughout the Abdomen 1 Funk LM, Perry KA, Narula VK, Mikami DJ, Melvin WS. Current national practice patterns for inpatient management of ventral ab do minal wall hernia in the United States. Surg Endosc . 2013;27(11):4104 - 4112.
6 Ventral Hernia: Complex Patient Population • CDC Wound Class I (clean) • Healthier patients - no co - morbidities • Primary hernia repair • CDC Wound Class II (clean - contaminated) • Patient co - morbidities (i.e. obesity, diabetes, COPD) • May have prior hernia repair failure • CDC Wound Class III (contaminated) & IV (infected) • Large defects • Infected synthetic mesh removals • Multiple prior hernia repair failures SIMPLE MODERATE COMPLEX Ventral Hernia Complexity Objective is to give patient the best repair the first time to prevent the simple patient from becoming the complex
7 Current Ventral Hernia Treatment Options: No Perfect Product PERMANENT SYNTHETIC MESH RESORBABLE SYNTHETIC MESH BIOLOGIC MESH Ventralight ™ Parietex ™ ProGrip ™ PROCEED ® P HASIX ™ Mesh GORE ® BIO - A ® Strattice™ SurgiMend ® Gentrix ® XenMatrix ™ Natural Repair Products Simple Ventral Hernia Inguinal Hernia Complex, Moderate Ventral Repair / Abdominal Wall Reconstruction Hiatal Hernia Repair
8 ▫ Persistent inflammatory response ▫ Encapsulation of implant ▫ Chronic post operative pain ▫ Scar tissue / lack of remodeling ▫ Mesh infections ▫ Significant costs of re - operation ▫ Organ erosion or perforation ▫ 6,000 related U.S. lawsuits ▫ Danish Hernia Database: ~17% reintervention at five years 1 Limitations of Reconstruction Materials Used in Hernia Repair 1. Kokotovic , Bisgaard and Helgstrand , Long - term Recurrence and Complications Associated With Elective Incisional Hernia Repair. JAMA. 2016;316(15):1575 - 1582. doi:10.1001/jama.2016.15217 (on - line) 2. Roth, JS et. al, (2017) “Prospective evaluation of poly - 4 - hydroybutyrate mesh in CDC class I/high - risk ventral and incisional hernia repair: 18 - month follow - up.” Surgical Endoscopy. 3. Itani , KMF et. al, (2012) “Prospective study of single - stage repair of contaminated hernias using a biologic porcine tissue matrix: T he RICH Study” Surgery ▫ Inflammatory response until absorbed ▫ Encapsulation of implant or until absorbed ▫ Scar tissue / lack of remodeling ▫ Mesh infection until resorbed ▫ Organ erosion or perforation ▫ Lack of mid - term and long - term reinforcement ▫ Recurrence rate of 12% at 18 - months follow - up 2 ▫ Lack of strength or durability ▫ Prone to laxity and stretching ▫ Difficulty in surgeon handling ▫ Difficult using in robotic surgery / LAP ▫ High costs ▫ RICH study: recurrence rates of 22% and 33% at 12 - months and 24 - months follow - up, respectively 3 PERMANENT SYNTHETIC MESH RESORBABLE SYNTHETIC MESH BIOLOGIC MATRICES
9 Purposefully Designed Biologic & Polymer Solutions for Specific Clinical Needs Our Solution: New Category of Tissue Reinforcement Materials Biologic Tissue derived from sheep Polymer Fibers Innovative Textile Engineering Hernia & Ab Wall Reconstruction Plastic Reconstruction Surgeon Collaboration Polymer fibers interwoven through layers of biologic material in unique embroidered patterns
10 High Quality Biologic Material Drives Technology Platform TELA maintains a definitive license agreement with Aroa BioSurgery for the use of ovine rumen ▫ Product development, commercial strategy & execution and clinical data generation ▫ Revenue sharing agreement based on net sales; TELA retains 73% of net sales TELA ▫ Manufacturing and supply of product ▫ Aroa receives 27% of net sales Aroa BioSurgery ▫ Aroa has two issued patents protecting the use of ovine rumen for use as a source of extracellular matrix ▫ Exclusive license in North America and Europe for hernia repair, abdominal wall and breast reconstruction ▫ Ovine rumen is high quality biologic source material, sourced from New Zealand and subject to strict quality controls ▫ Plentiful supply – ~27 million sheep in New Zealand ▫ Low cost of goods ▫ Homogenous, intact, minimally processed material – lends itself to be a good building block for fabrication into medical devices
11 Our Solution: A New Category of Soft Tissue Reinforcement Materials ▫ Designed in close collaboration with more than 100 surgeons ▫ Products designed with over 95% biologic material (<5% polymer/synthetic content) ▫ Benefits of both biologic materials and polymer materials ▫ Supports range of surgical techniques Improve Performance Over Existing Reconstruction Materials Improved Biologic Response Lower Upfront Costs ▫ Reduced foreign body inflammatory response ▫ Improved outcomes of soft tissue reconstructions ▫ Enhanced remodeling of soft tissue and rate of healing ▫ Customers realize ~20% to 40% cost - savings over leading biologic materials and resorbable synthetic mesh ▫ Provides benefits of advanced biologic repair to more patients
12 OviTex: a New Approach to Soft Tissue Reconstruction for Hernia Repair and Abdominal Wall Reconstruction An innovative reinforced tissue matrix designed to reduce stretch compared to biologic matrices and long - term complications experienced with resorbable and permanent synthetic meshes Unique permeable design facilitates rapid fluid transfer and movement of cells through the device Layers of biologic material enable functional tissue remodeling Interwoven polymer for added strength and improved handling Lockstitch embroidery pattern creates a ripstop effect and prevents unraveling when cut
13 Comprehensive Portfolio for a Range of Hernia Types & Surgical Techniques Images represent permanent polymer OviTex products. Resorbable polymer products have clear polymer. * Biomechanical data on file. CONFIGURATION OviTex 4 - layer device, not intended for intraperitoneal placement Strength*: + Common Procedures: Moderate ventral hernia (pre - peritoneal placement), inguinal hernia, hiatal hernia OviTex 2S 8 - layer device, with 2 “smooth sides” suitable for intraperitoneal placement Strength*: +++ Common Procedures: Complex ventral hernia and abdominal wall reconstruction and can be used for bridging OviTex 1S 6 - layer device, with “smooth side” suitable for intraperitoneal placement Strength*: ++ Common Procedures: Moderate to complex ventral hernia Each configuration is available with either permanent (polypropylene) polymer or resorbable (polyglycolic acid) polymer reinforcing the same biologic material.
14 ▫ OviTex LPR is specifically tailored for robotic - assisted hernia surgical repairs ▫ Significant increase in robotic hernia repairs in last few years ▫ Robotic - assisted hernia repair provides the benefits of laparoscopic repair ▫ Designed for improved surgical handling, access, and primary closure of hernia ▫ Designed for use with a trocar ▫ 4 total SKUs available, following commercial introduction of 3 additional SKUs in December 2019 ▫ Products expected to be used most frequently in simple - moderate ventral hernia patients OviTex LPR for Laparoscopic & Robotic - Assisted Repair
15 91 Adult Patient, Prospective, Single Arm, Multicenter BRAVO Study ▫ First 32 patients at 12 - months show 0% hernia recurrence More than 200 Non - Human Primates ▫ OviTex demonstrates more rapid tissue integration and revascularization compared to biologic matrices and lower inflammatory response and better functional tissue remodeling compared to permanent and resorbable synthetic mesh 12 clinical publications ▫ Strong clinical efficacy and low complication rates in range of hernias Continue to build clinical evidence ▫ Additional BRAVO data over time ▫ Plan to initiate a post - market study of OviTex in robotic - assisted hernia repair surgery Disruptive Technology Supported by a Compelling Body of Clinical Evidence
16 Multiple Future Analyses of BRAVO Data Planned for 2020 Q1 2020 Q2 2020 Q3 2020 Q4 2020 • ~25 - patients at 24 - months • ~50 - patients at 12 - months • ~75 - patients at 3 - months • ~75 patients at 12 - months • ~50 - patients at 24 - months ▫ Primary focus is hernia recurrence rate at each time point ▫ Additional information on surgical site occurrence rate will also be analyzed ▫ Study design allows for robotic, laparoscopic and open implantation of OviTex 1S, allowing for potential sub - analyses by surgical technique ▫ Data will be submitted for presentation at key medical conferences throughout the year BRAVO Study is fully enrolled (n=91) and characterizes OviTex performance in moderate - to - complex ventral hernia patients
17 OviTex BRAVO Study Shows Low Recurrence Rate at 12 - months Product Name Tissue Reinforcement Material Hernia Recurrence Rate Number of Hernia Recurrence Number of Patients who Completed Follow - up Follow - up Period in Months OviTex Reinforced Tissue Matrix 0 32 12 Product Name Tissue Reinforcement Material Hernia Recurrence Rate 1 Number of Hernia Recurrence 1 Number of Patients who Completed Follow - up 1 Follow - up Period in Months Phasix Resorbable Synthetic Mesh 5 95 12 Phasix Resorbable Synthetic Mesh 11 95 18 Phasix Resorbable Synthetic Mesh 19 82 36 Strattice Biologic Matrix 15 69 12 Strattice Biologic Matrix 22 67 24 12% 23% 22% 33% 5% 0% 1) Hernia Recurrence Rate based on number of hernia recurrences reported in patients who completed follow up and patients who re ported recurrent hernia before the specified follow up period. Clinical literature and conference presentations included hernia recurrence rates based on number of hernia recurrences in patients who comprised the in itial intent - to - treat population (including those who did not complete the follow up period and did not report a hernia recurrence). OviTex BRAVO Study Results from Post - Market Clinical Studies of Competitive Materials
18 ▫ Use of biologic matrices validated by growing clinical literature ▫ Biologics provide the following clinical benefits: ▫ Ability to define shape and position ▫ Soft tissue reinforcement ▫ Improvement of tissue quality ▫ Aids in defining the pocket and allows for more immediate tissue expansion ▫ Reduced inflammatory response ▫ Existing biologics are costly, prone to excessive stretch over time, and difficult for surgeons to handle We believe Plastic and Reconstructive Surgery Represents a Significant Market Opportunity Note: Management estimate. Market size based on sales of current biologics ~$500 Million Annual U.S. Market Opportunity Uses ▫ Breast reconstruction ▫ Head and neck surgery ▫ Chest wall reconstruction ▫ Pelvic reconstruction ▫ Extremities reconstruction
19 OviTex PRS: Purposely Designed for Plastic and Reconstructive Surgery Layers of biologic material enable functional tissue remodeling Corner - lock diamond embroidery pattern allows the product to stretch while maintaining its shape Fenestrations and slits facilitate fluid management, allow for rapid cellular infiltration, and create a directional bias to the stretch 510(k) cleared April 2019; limited launch ongoing with plans to expand launch in 1H 2020 An innovative reinforced tissue matrix designed to improve outcomes by facilitating fluid management and controlling degree and direction of stretch
20 Commercial Organization Recognize need for integrated approach to account management to meet the needs of all stakeholders (surgeons, supply chain & OR / materials management) ▫ Single direct sales effort calling on General, Plastic Recon, Colorectal & Trauma surgeons ▫ Supplement high volume territories with Associate Account Managers ▫ Model is scaled at a regional level, with span - of - control for Regional Managers at ~6 - 8 Account Managers Regional Manager Account Managers Business Manager Contract implementation; drive business through supply chain & OR relationships Clinical Development Specialist KOL development; clinical education to surgeons about products & surgical techniques
21 1. Data based on estimates from Definitive Healthcare and IQVIA Hospital Procedure and Diagnosis data. Focused on Driving Utilization within Accessed Accounts Contracts in place with multiple national and regional Group Purchasing Organizations (GPOs) Current GPO contracts provide access to ~1,900 hospitals across the U.S., estimated to perform over ~135,000 addressable soft tissue reconstruction procedures 1 Data - driven, targeted implementation strategy Account Manager hiring for new territories focused on areas with high concentrations of accessed accounts
22 Growth Strategy • U.S. sales force expansion • Surgeon education • Target high - decile hernia and plastic and recon. surgeons Current • Drive adoption within health systems under GPO contracts • Publish BRAVO clinical and health economics data • Pursue additional contracts with large GPOs and IDNs Near - Term • New product features and designs for OviTex and OviTex PRS • OviTex LPR clinical study data • Support investigator - led clinical studies for OviTex PRS Long - Term
23 Historical Financial Summary 2018 2019 2018 2019 Nine Months Ended Sep 30 Three Months Ended Sep 30 ($ millions) ($ millions) ▫ Revenue: $4.7 – 4.9 million ▫ 94 – 102% increase over prior year period ▫ 18 – 23% increase over prior quarter ▫ 2019E total revenue: $15.3 – 15.5 million ▫ 85 – 87% increase over 2018 ▫ Cash, cash equivalents & short - term investments: $54.6 million Q4 2019 Preliminary Results 81% growth 80% growth
24 Statement of Operations Nine months Ended September 30, Three months Ended September 30, 2018 2019 2018 2019 Revenue $5.8 $10.6 $2.2 $4.0 Cost of revenue 3.2 4.0 0.8 1.3 Amortization of Intangible Assets 0.7 0.2 0.1 0.1 Gross Profit $1.9 $6.3 $1.4 $2.6 Gross Margin 33% 60% 62% 66% Operating expenses: Sales and marketing 9.6 12.7 3.6 4.7 General and administrative 3.4 3.7 1.4 1.2 Research and development 3.4 3.2 1.0 0.5 Gain on litigation settlement (2.2) 0.0 (2.2) 0.0 Total operating expenses 14.2 19.6 3.9 6.5 Loss from operations ($12.3) ($13.3) ($2.5) ($3.9) Other (expense) income, net (1.4) (2.6) (0.3) (0.8) Net loss ($13.7) ($15.9) ($2.8) ($4.7)
25 Investment Highlights Advanced reinforced tissue matrix portfolio supported by compelling clinical evidence Focused on ~$2.0 billion annual U.S. total addressable markets Well - defined high - decile surgeon customers targeted by growing direct sales force Long - term supply agreement that provides pricing flexibility — cost savings to healthcare systems Established DRG - based reimbursement pathway for hernia repair Recent product launches in growing categories: robotic hernia surgery + plastic and reconstructive surgery Broad intellectual property portfolio Industry leading executive team with proven track record