TELA Bio, Inc. ("TELA") (Nasdaq: 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 first quarter ended March 31, 2021.
First Quarter 2021 Financial Results and Business
Highlights
- Reported revenue of $5.9 million for
the first quarter of 2021, increasing 58% over the first quarter of
2020;
- OviTex LPR product line continues to
experience high utilization in robotic and MIS procedures and the
first quarter of 2021 represented the highest volume quarter for
LPR products;
- Hosted successful Key Opinion Leader
Webinar featuring surgeons speaking on their use of OviTex®
Reinforced Tissue Matrix for simple and complex hernia procedures;
and
- 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.
"We are very pleased with our revenue growth in the first
quarter despite the ongoing headwinds from COVID-19, and we are
encouraged by the increasing demand for our products, particularly
our LPR product line, as we head into the second quarter," said
Antony Koblish, co-founder, President and Chief Executive Officer
of TELA Bio. "Along with the expected improvement of procedure
volumes throughout 2021, we anticipate the current litigation
surrounding synthetic mesh may increase patient demand for
non-synthetic options. OviTex was purposefully designed to provide
patients a more natural repair, and we believe TELA Bio is
well-positioned to experience top-line growth in 2021 as the
portfolio is expected to gain increased utilization by general and
plastic reconstructive surgeons."
First Quarter 2021 Financial Results
Revenue was $5.9 million for the first quarter
of 2021, an increase of 58% compared to the prior year period
despite experiencing increased volatility in demand for our
products in January due to the COVID-19 resurgence. The increase in
revenue was primarily driven by an increase in unit sales of our
products due to the expansion of our commercial organization and
increased penetration within existing customer accounts.
Gross profit was $3.5 million for the first
quarter of 2021, or 59% of revenue, compared to $2.2 million, or
59% of revenue, in the same period in 2020.
Operating expenses were $10.7 million in the
first quarter of 2021, compared to $8.7 million in the same period
in 2020. The increase was due to the expansion of our
commercialization activities, higher personnel costs, and increased
research and development expenses.
Loss from operations was $7.3 million in the
first quarter of 2021, compared to a loss from operations of $6.5
million in the same period in 2020.
Net loss was $8.1 million in the first quarter
of 2021, compared to a net loss of $7.2 million in the same period
in 2020.
Cash and Cash Equivalents at March 31, 2021
were $65.8 million.
Financial Outlook
For the full year 2021, TELA Bio is maintaining the total
revenue guidance 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 and provide a corporate update on Thursday,
May 13, 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 7381947. 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 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, expected increases in procedure volumes in 2021
and expected increases in the utilization rate of our products by
general and plastic reconstructive surgeons. 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 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.
Investor ContactGreg
Chodaczek347-620-7010 ir@telabio.com
TELA
Bio, Inc.Consolidated Balance
Sheets(In thousands, except share and per share
amounts)(Unaudited)
|
March 31, |
|
December 31, |
|
2021 |
|
2020 |
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
65,829 |
|
|
$ |
74,394 |
|
Accounts receivable, net |
|
2,795 |
|
|
|
2,683 |
|
Inventory |
|
4,688 |
|
|
|
3,907 |
|
Prepaid expenses and other assets |
|
1,892 |
|
|
|
2,241 |
|
Total current assets |
|
75,204 |
|
|
|
83,225 |
|
Property and equipment,
net |
|
584 |
|
|
|
626 |
|
Intangible assets, net |
|
2,531 |
|
|
|
2,607 |
|
Total assets |
$ |
78,319 |
|
|
$ |
86,458 |
|
|
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
965 |
|
|
$ |
652 |
|
Accrued expenses and other current liabilities |
|
4,673 |
|
|
|
5,953 |
|
Total current liabilities |
|
5,638 |
|
|
|
6,605 |
|
Long‑term debt with related
party |
|
30,982 |
|
|
|
30,827 |
|
Other long‑term
liabilities |
|
8 |
|
|
|
— |
|
Total liabilities |
|
36,628 |
|
|
|
37,432 |
|
|
|
|
|
|
|
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;
14,440,411 and 14,437,289 shares issued and 14,440,275 and
14,437,107 shares outstanding at March 31, 2021 and December 31,
2020, respectively |
|
14 |
|
|
|
14 |
|
Additional paid-in capital |
|
246,548 |
|
|
|
245,736 |
|
Accumulated other comprehensive loss |
|
(82 |
) |
|
|
(71 |
) |
Accumulated deficit |
|
(204,789 |
) |
|
|
(196,653 |
) |
Total stockholders' equity |
|
41,691 |
|
|
|
49,026 |
|
Total liabilities and stockholders' equity |
$ |
78,319 |
|
|
$ |
86,458 |
|
TELA
Bio, Inc.Consolidated Statements of
Operations and Comprehensive Loss(In thousands,
except share and per share
amounts)(Unaudited)
|
Three months ended |
|
March 31, |
|
2021 |
|
2020 |
Revenue |
$ |
5,877 |
|
|
$ |
3,726 |
|
Cost of revenue (excluding
amortization of intangible assets) |
|
2,336 |
|
|
|
1,450 |
|
Amortization of intangible
assets |
|
76 |
|
|
|
76 |
|
Gross profit |
|
3,465 |
|
|
|
2,200 |
|
Operating expenses: |
|
|
|
|
|
Sales and marketing |
|
6,299 |
|
|
|
5,269 |
|
General and administrative |
|
2,756 |
|
|
|
2,518 |
|
Research and development |
|
1,679 |
|
|
|
912 |
|
Total operating expenses |
|
10,734 |
|
|
|
8,699 |
|
Loss from operations |
|
(7,269 |
) |
|
|
(6,499 |
) |
Other (expense) income: |
|
|
|
|
|
Interest expense |
|
(889 |
) |
|
|
(879 |
) |
Other income |
|
22 |
|
|
|
158 |
|
Total other expense |
|
(867 |
) |
|
|
(721 |
) |
Net loss |
$ |
(8,136 |
) |
|
$ |
(7,220 |
) |
Net loss per common share,
basic and diluted |
$ |
(0.56 |
) |
|
$ |
(0.63 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
14,438,405 |
|
|
|
11,406,783 |
|
Comprehensive loss: |
|
|
|
|
|
Net loss |
$ |
(8,136 |
) |
|
$ |
(7,220 |
) |
Foreign currency translation adjustment |
|
(11 |
) |
|
|
27 |
|
Comprehensive loss |
$ |
(8,147 |
) |
|
$ |
(7,193 |
) |
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