TELA Bio, Inc. ("TELA"), a commercial-stage medical technology
company focused on designing, developing, and marketing innovative
tissue reinforcement materials to address unmet needs in soft
tissue reconstruction, today reported financial results for the
fourth quarter and full year ended December 31, 2020.
Recent Highlights
- Recognized revenue of $5.7 million
for the fourth quarter and $18.2 million for the full year 2020,
representing increases of 17% and 18%, respectively, over the
corresponding periods of 2019
- Conducted virtual VIP tours and
educational webinars to approximately 200 surgeons as part of the
TELA LIVE virtual programs
- Continued to expand the commercial
team to drive growth initiatives
- Published additional positive data,
including initial two-year data, from the BRAVO study evaluating
OviTex® Reinforced Tissue Matrix for the treatment of ventral
hernias showing favorable recurrence rates
"Despite the many challenges of COVID-19, we continue to see
momentum in our business and were able to generate fourth quarter
and 2020 revenue growth," said Antony Koblish, co-founder,
President and Chief Executive Officer of TELA Bio. "I am very proud
and humbled by the way our team came together over the past year
during these uncertain times. Over the course of 2020, we focused
on engaging our customers virtually, optimizing our product
portfolio, and completing the 12-month analysis of our patients in
our BRAVO study. As a result of these accomplishments and our
strong financial position, we believe we are well positioned to
gain market share and accelerate revenue growth over the long
term."
The BRAVO study is a multi-center prospective study designed to
evaluate the clinical performance of OviTex Reinforced Tissue
Matrix for the treatment of ventral hernias. Seventy-six (76)
patients have completed their 12-month follow-up with only two
having experienced a hernia recurrence, both adjacent to the
original repair with the OviTex repairs remaining intact. Fifty-one
(51) patients reached the 24-month follow-up with none experiencing
a recurrence.
"While we intend to build on this momentum in 2021, I am deeply
saddened to report the recent loss of our Chief Medical Officer and
co-founder, Maarten Persenaire, who died unexpectantly on March
7th. Maarten was instrumental in the founding of the company and
the development of OviTex. His lasting contribution will live on in
TELA Bio as well as with the surgeons and patients we serve. All of
us will be forever grateful to Maarten, and we will continue to
honor and build upon his legacy."
Fourth Quarter 2020 Financial Results
Revenue was $5.7 million for the fourth quarter
of 2020, an increase of 17% compared to the prior year period
despite experiencing increased volatility in demand for our
products in December due to the COVID resurgence. The increase was
due primarily to the expansion of the commercial organization and
increased penetration within existing customer accounts.
Gross profit was $3.7 million for the fourth
quarter of 2020, or 65% of revenue, compared to $3.0 million, or
61% of revenue, in the same period in 2019. The increase in gross
margin was due primarily to longer shelf life and inventory
management for our OviTex products.
Operating expenses were $10.4 million in the
fourth quarter of 2020, compared to $8.8 million in the same period
in 2019. The increase was due to the expansion of our
commercialization activities, higher personnel costs, and increased
insurance premiums.
Loss from operations was $6.7 million in the
fourth quarter of 2020, compared to a loss from operations of $5.8
million in the same period in 2019.
Net loss was $7.8 million in the fourth quarter
of 2020, compared to a net loss of $6.5 million in the same period
in 2019.
Full Year 2020 Financial Results
Revenue was $18.2 million for the full year
2020, an increase of 18% compared to the full year 2019. This
increase was due primarily to the commercial organization's
expansion and increased penetration within existing customer
accounts.
Gross profit was $11.2 million for the full
year 2020, or 62% of revenue, compared to $9.3 million, or 60% of
revenue, for the full year 2019. The gross margin increase was due
primarily to longer shelf life and inventory management for our
OviTex products.
Operating expenses were $36.5 million for the
full year 2020, compared to $28.4 million in the prior year. The
increase was due to the expansion of our commercialization
activities, higher personnel costs and increased costs associated
with operating as a public company which was partially offset by
lower travel and consulting expenses resulting from the cost
containment actions taken in response to the COVID-19 pandemic.
Loss from operations was $25.3 million for the
full year 2020, compared to a loss from operations of $19.2 million
for the full year 2019.
Net loss was $28.8 million for the full year
2020, compared to a net loss of $22.4 million for the full year
2019.
Cash and cash equivalents on December 31, 2020
were $74.4 million.
Financial Outlook
For the full year 2021, TELA Bio expects total revenue to be in
the range of $27.0 million to $30.0 million, representing growth of
48% to 65% over the prior year period. Continued uncertainty
relating to the dynamic environment with the COVID-19 pandemic
could materially impact our estimate.
Conference Call and Webcast Details
The company will host a live conference call and webcast to
discuss these results on Wednesday, March 24, 2021 at 4:30 PM
ET.
To participate in the call, please dial (855) 548-1219
(domestic) or (409) 217-8881 (international) and provide conference
ID 8550518. The live webcast will be available on the Events &
Presentations page of the investors section of TELA's website.
About TELA Bio, Inc.
TELA Bio Inc. (NASDAQ: TELA) is a commercial-stage medical
technology company focused on designing, developing, and marketing
innovative tissue reinforcement materials to address unmet needs in
soft tissue reconstruction. The company is committed to providing
patients with advanced, economically effective biologic material
repair solutions to patients to minimize long-term exposure to
permanent synthetic materials and improve clinical outcomes. TELA
Bio's OviTex® and OviTex PRS Reinforced Tissue Matrix products are
purposefully designed to address the shortcomings of existing
reinforcement materials in hernia repair, abdominal wall
reconstruction and plastic and reconstructive surgery. For more
information, visit www.telabio.com.
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. 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. Such forward-looking statements include
statements relating to our expected revenue and revenue growth for
the full year 2021. 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
differ materially and adversely from those indicated by such
forward-looking statements including, among others: the impact to
our business of the ongoing COVID-19 pandemic, including but not
limited to any impact on our ability to market our products, demand
for our products due to deferral of procedures using our products
or disruption in our supply chain, our ability to achieve or
sustain profitability, our ability to gain market acceptance for
our products and to accurately forecast and meet customer demand,
our ability to compete successfully, our ability to enhance our
product offerings, development and manufacturing problems, capacity
constraints or delays in production of our products, maintenance of
coverage and adequate reimbursement for procedures using our
products, product defects or failures. These and other risks and
uncertainties are described more fully in the "Risk Factors"
section and elsewhere in our filings with the Securities and
Exchange Commission and available at www.sec.gov, including in our
Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. 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 update our 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.
Investor ContactGreg
Chodaczek347-620-7010 ir@telabio.com
|
TELA Bio, Inc.Consolidated Balance
Sheets(Unaudited, in thousands, except share and
per share amounts) |
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2020 |
|
2019 |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
74,394 |
|
|
$ |
45,302 |
|
Short-term investments |
|
|
— |
|
|
|
9,285 |
|
Accounts receivable, net |
|
|
2,683 |
|
|
|
2,836 |
|
Inventory |
|
|
3,907 |
|
|
|
4,603 |
|
Prepaid expenses and other assets |
|
|
2,241 |
|
|
|
2,308 |
|
Total current assets |
|
|
83,225 |
|
|
|
64,334 |
|
Property and equipment,
net |
|
|
626 |
|
|
|
677 |
|
Intangible assets, net |
|
|
2,607 |
|
|
|
2,911 |
|
Total assets |
|
$ |
86,458 |
|
|
$ |
67,922 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
652 |
|
|
$ |
3,171 |
|
Accrued expenses and other current liabilities |
|
|
5,953 |
|
|
|
3,542 |
|
Total current liabilities |
|
|
6,605 |
|
|
|
6,713 |
|
Long-term debt with related
party |
|
|
30,827 |
|
|
|
30,243 |
|
Other long-term
liabilities |
|
|
— |
|
|
|
4 |
|
Total liabilities |
|
|
37,432 |
|
|
|
36,960 |
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
Preferred stock; $0.001 par value: 10,000,000 shares authorized; no
shares issued and outstanding |
|
|
— |
|
|
|
— |
|
Common stock; $0.001 par value: 200,000,000 shares authorized;
14,437,289 and 11,406,976 shares issued and 14,437,107 and
11,406,221 shares outstanding at December 31, 2020 and 2019,
respectively |
|
|
14 |
|
|
|
11 |
|
Additional paid-in capital |
|
|
245,736 |
|
|
|
198,829 |
|
Accumulated other comprehensive loss |
|
|
(71 |
) |
|
|
(19 |
) |
Accumulated deficit |
|
|
(196,653 |
) |
|
|
(167,859 |
) |
Total stockholders' equity |
|
|
49,026 |
|
|
|
30,962 |
|
Total liabilities and stockholders' equity |
|
$ |
86,458 |
|
|
$ |
67,922 |
|
|
|
|
|
|
|
|
|
|
|
TELA Bio, Inc.Consolidated Statements
of Operations(Unaudited, in thousands, except
share and per share amounts) |
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenue |
|
$ |
5,667 |
|
|
$ |
4,864 |
|
|
$ |
18,213 |
|
|
$ |
15,446 |
|
Cost of revenue (excluding
amortization of intangible assets) |
|
|
1,929 |
|
|
|
1,825 |
|
|
|
6,675 |
|
|
|
5,870 |
|
Amortization of intangible
assets |
|
|
76 |
|
|
|
76 |
|
|
|
304 |
|
|
|
304 |
|
Gross profit |
|
|
3,662 |
|
|
|
2,963 |
|
|
|
11,234 |
|
|
|
9,272 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Sales and marketing |
|
|
6,377 |
|
|
|
5,382 |
|
|
|
22,111 |
|
|
|
18,060 |
|
General and administrative |
|
|
2,869 |
|
|
|
2,486 |
|
|
|
10,143 |
|
|
|
6,223 |
|
Research and development |
|
|
1,163 |
|
|
|
921 |
|
|
|
4,255 |
|
|
|
4,151 |
|
Total operating expenses |
|
|
10,409 |
|
|
|
8,789 |
|
|
|
36,509 |
|
|
|
28,434 |
|
Loss from operations |
|
|
(6,747 |
) |
|
|
(5,826 |
) |
|
|
(25,275 |
) |
|
|
(19,162 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(903 |
) |
|
|
(884 |
) |
|
|
(3,564 |
) |
|
|
(3,609 |
) |
Change in fair value of preferred stock warrant liability |
|
|
— |
|
|
|
(1 |
) |
|
|
— |
|
|
|
(5 |
) |
Other (expense) income |
|
|
(140 |
) |
|
|
179 |
|
|
|
45 |
|
|
|
351 |
|
Total other expense |
|
|
(1,043 |
) |
|
|
(706 |
) |
|
|
(3,519 |
) |
|
|
(3,263 |
) |
Net loss |
|
|
(7,790 |
) |
|
|
(6,532 |
) |
|
|
(28,794 |
) |
|
|
(22,425 |
) |
Accretion of redeemable
convertible preferred stock to redemption value |
|
|
— |
|
|
|
(940 |
) |
|
|
— |
|
|
|
(7,783 |
) |
Net loss attributable to
common stockholders |
|
$ |
(7,790 |
) |
|
$ |
(7,472 |
) |
|
$ |
(28,794 |
) |
|
$ |
(30,208 |
) |
Net loss per common share,
basic and diluted |
|
$ |
(0.54 |
) |
|
$ |
(1.22 |
) |
|
$ |
(2.23 |
) |
|
$ |
(17.10 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
14,432,974 |
|
|
|
6,127,486 |
|
|
|
12,934,421 |
|
|
|
1,766,412 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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