Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a global insulin
delivery and diabetes technology company, today reported its
financial results for the quarter ended June 30, 2023 and updated
its financial guidance for the year ending December 31, 2023.
Second Quarter and Recent Highlights
- Worldwide installed base increased 16 percent to approximately
437,000 in-warranty customers compared to the second quarter
2022.
- Commenced U.S. launch of Tandem Source, a data management
application designed to be a centralized digital ecosystem for
customers and healthcare providers worldwide.
- Enrolled first participant in pivotal study for people living
with type 2 diabetes using Control-IQ technology.
- Received U.S. Food and Drug Administration clearance for Tandem
Mobi, the world’s smallest durable insulin delivery system.
- $507.2 million in cash, cash equivalents & short-term
investments as of June 30, 2023.
“In the second quarter, we demonstrated exceptional progress
with our new technology innovations, while driving operational
improvements throughout our business and achieving sales
expectations,” said John Sheridan, president and chief executive
officer. “We are navigating 2023 to position Tandem for future
growth and long-term success by delivering on the most exciting
portfolio in insulin therapy management, while furthering our
mission to offer choice and simplified solutions to improve the
lives of people with diabetes.”
Second Quarter 2023 Financial Results Compared to
2022
In September 2022, the Company began offering the Tandem Choice
Program (Tandem Choice) to eligible t:slim X2 customers to provide
a pathway to ownership of its newest hardware platform, Tandem
Mobi, for a fee when available. As a result of this program, and as
previously announced, the Company is providing select financial
results for both GAAP and non-GAAP. Additional information,
including the accounting treatment of this program and other
non-GAAP measures, can be found under the heading “Reconciliation
of GAAP versus Non-GAAP Financial Results” in this press
release.
Three Months Ended
Six Months Ended
June 30,
June 30,
$ in
millions
2023
2023
2022
2023
2023
2022
GAAP
Non-GAAP
GAAP
GAAP
Non-GAAP
GAAP
Pump Shipments
United States
18,964
N/A
20,818
35,967
N/A
39,476
Outside United States
10,530
N/A
11,296
16,582
N/A
20,733
Total Worldwide
29,494
N/A
32,114
52,549
N/A
60,209
Sales
United States
$
142.5
$
144.8
$
145.7
$
273.7
$
278.1
$
277.0
Outside United States
53.4
53.4
54.6
91.6
91.6
99.2
Total Worldwide
$
195.9
$
198.2
$
200.3
$
365.3
$
369.7
$
376.2
- Gross profit: GAAP gross profit was $101.7 million,
compared to $101.9 million. GAAP gross margin was 52 percent,
compared to 51 percent. Non-GAAP gross profit(1) was $104.0
million. Non-GAAP gross margin(1) was 52 percent.
- Operating income (loss): GAAP operating loss totaled
$38.8 million, or negative 20 percent of sales, compared to
operating loss of $12.2 million, or negative 6 percent of sales.
Non-GAAP operating loss(1) totaled $22.4 million, or negative 11
percent of sales. Adjusted EBITDA(1) was $5.3 million, or 3 percent
of sales, compared to $11.4 million, or 6 percent of sales.
- Net income (loss): GAAP net loss(1) was $35.8 million,
compared to net loss of $15.1 million. Non-GAAP net loss(1) was
$19.4 million.
See tables for additional financial information.
2023 Financial Guidance
“The upcoming addition of four new offerings to our portfolio
sets a path for renewed momentum as we bring the benefits of Tandem
technology to more people living with diabetes worldwide,” said
Leigh Vosseller, executive vice president and chief financial
officer. “In the near-term, we anticipate that our measured rate of
market releases has the potential for disruption and reduced sales
visibility. We are resetting our guidance to provide our minimum
sales expectation for the remainder of the year, while focusing on
driving the success of our new offerings and operational
efficiencies across the business.”
For the year ending December 31, 2023, the Company is updating
its 2023 financial guidance as follows:
- Non-GAAP sales(1) are estimated to be at least $785 million
with sales in third quarter of at least $190 million.
- Sales inside the United States of at least $575 million with
sales in the third quarter of at least $135 million.
- Sales outside the United States of at least $210 million with
sales in the third quarter of at least $55 million.
- Non-GAAP gross margin(1) is estimated to be approximately 51
percent.
- Adjusted EBITDA margin(1) is estimated to be at least breakeven
as a percent of sales.
- Includes approximately 3 percent from the impact of operating
costs associated with the acquisitions of Capillary Biomedical and
AMF Medical.
- Non-cash charges included in cost of goods sold and operating
expenses are estimated to be approximately $110 million. This
includes:
- Approximately $95 million non-cash, stock-based compensation
expense.
- Approximately $15 million depreciation and amortization
expense.
(1)
A reconciliation of non-GAAP
financial measures to their closest GAAP equivalent and additional
information can be found in Table E and under the heading
“Reconciliation of GAAP versus Non-GAAP Financial Results.”
Non-GAAP Financial Measures
Certain non-GAAP financial measures are presented in this press
release to provide information that may assist investors in
understanding the Company’s financial results and assessing its
prospects for future performance. The Company believes these
non-GAAP financial measures are important operating performance
indicators because they exclude items that are unrelated to, and
may not be indicative of, the Company’s core operating results.
These non-GAAP financial measures, as calculated, may not
necessarily be comparable to similarly titled measures of other
companies and may not be appropriate measures for comparing the
performance of other companies relative to the Company. These
non-GAAP financial results are not intended to represent, and
should not be considered to be more meaningful measures than, or
alternatives to, measures of operating performance as determined in
accordance with GAAP. To the extent the Company uses such non-GAAP
financial measures in the future, they will be calculated using a
consistent method from period to period. A reconciliation of each
of the GAAP financial measures to the most directly comparable
non-GAAP financial measures has been provided in Table E
“Reconciliation of GAAP versus Non-GAAP Financial Results” attached
to this press release.
In particular, the accounting treatment for Tandem Choice has a
high degree of complexity. In September 2022 when the program was
launched, the Company began deferring a portion of sales for each
eligible t:slim X2 pump shipped in the United States. Such
deferrals will be recognized on a customer-by-customer basis
following the commercial launch of the Company’s new hardware
platform, Tandem Mobi. The timing of recognition will be based on
either a) an affirmative election to participate in Tandem Choice
or b) expiration of the right to participate. Notably:
- Offering the program does not impact the economics associated
with how or when the initial pump sale is reimbursed.
- Customer eligibility is automatic and no election is necessary
to participate in Tandem Choice at the time of a t:slim X2
purchase. An affirmative election is only required when the new
hardware platform, Tandem Mobi, is commercially available, at which
time any customer fees will be received and recognized as a
sale.
- The expiration date of Tandem Choice is December 31, 2024.
Consistent with SEC regulations, the Company has not provided a
reconciliation of forward-looking non-GAAP financial measures to
the most directly comparable GAAP financial measures in reliance on
the “unreasonable efforts” exception set forth in the applicable
regulations, because there is substantial uncertainty associated
with predicting any future adjustments that may be made to the
Company’s GAAP financial measures in calculating the non-GAAP
financial measures.
Conference Call
The Company will hold a conference call and simultaneous webcast
today at 4:30pm Eastern Time (1:30pm Pacific Time). The link to the
webcast will be available by accessing the Events &
Presentations tab in the Investor Center of the Tandem Diabetes
Care website at http://investor.tandemdiabetes.com, and will be
archived for 30 days. To access the call by phone, please use this
link
(https://register.vevent.com/register/BIb61cfe435b0f43f5a67b990141f26d3d)
and you will be provided with dial-in details, including a personal
pin.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc., a global insulin delivery and
diabetes technology company headquartered in San Diego, California,
creates new possibilities for people living with diabetes, their
loved ones, and healthcare providers through a positively different
experience. The Company’s human-centered approach to design,
development, and support delivers innovative products and services
for people who use insulin. Tandem manufactures and sells the
t:slim X2 insulin pump with Control-IQ technology. For more
information, visit tandemdiabetes.com.
Tandem Diabetes Care, the Tandem logo, Control-IQ, Tandem Mobi
and t:slim X2 are either registered trademarks or trademarks of
Tandem Diabetes Care, Inc. in the United States and/or other
countries.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use
#tslimX2 and #TandemDiabetes. Follow Tandem Diabetes Care on
Facebook at www.facebook.com/TandemDiabetes. Follow Tandem Diabetes
Care on LinkedIn at
https://www.linkedin.com/company/tandemdiabetes.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, that concern matters that involve risks and uncertainties
that could cause actual results to differ materially from those
anticipated or projected in the forward-looking statements. These
forward-looking statements include statements regarding, among
other things, the Company’s projected financial results and the
ability to achieve other operational and commercial goals for this
year, including the launch of multiple new products. The Company’s
actual results may differ materially from those indicated in these
forward-looking statements due to numerous risks and uncertainties.
For instance, the Company’s ability to achieve projected financial
results will be impacted by market acceptance of the Company’s
existing products and products under development; products marketed
and sold or under development by competitors; the Company’s ability
to establish and sustain operations to support international sales,
including expanding into additional geographies; changes in
reimbursement rates or insurance coverage for the Company’s
products; the Company’s ability to meet increasing operational and
infrastructure requirements from higher customer interest and a
larger base of existing customers; the Company’s ability to
complete the development and launch of new products when
anticipated; risks associated with the regulatory approval process
for new products; the potential that newer products, or other
technological breakthroughs for the monitoring, treatment or
prevention of diabetes, may render the Company’s products obsolete,
less desirable; or may otherwise negatively impact the purchasing
trends of customers; reliance on third-party relationships, such as
outsourcing and supplier arrangements; global economic conditions;
and other risks identified in the Company’s most recent Annual
Report on Form 10-K, Quarterly Report on Form 10-Q, and other
documents that the Company files with the Securities and Exchange
Commission. Readers are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
of this release. Tandem undertakes no obligation to update or
review any forward-looking statement in this press release because
of new information, future events or other factors.
TANDEM DIABETES CARE,
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
Table A
(in thousands)
(Unaudited)
June 30,
December 31,
2023
2022
Assets
Current assets:
Cash, cash equivalents and short-term
investments
$
507,246
$
616,901
Accounts receivable, net
98,714
114,717
Inventories
147,599
111,117
Other current assets
10,745
7,241
Total current assets
764,304
849,976
Property and equipment, net
73,752
68,552
Operating lease right-of-use assets
91,054
110,626
Other long-term assets
17,566
23,631
Total assets
$
946,676
$
1,052,785
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable, accrued expenses and
employee-related liabilities
$
105,673
$
104,007
Operating lease liabilities
17,757
13,121
Deferred revenue
23,401
18,837
Other current liabilities
27,824
29,325
Total current liabilities
174,655
165,290
Convertible senior notes, net -
long-term
284,128
283,232
Operating lease liabilities -
long-term
118,400
123,524
Deferred revenue - long-term
15,305
16,874
Other long-term liabilities
24,954
23,918
Total liabilities
617,442
612,838
Total stockholders’ equity
329,234
439,947
Total liabilities and stockholders’
equity
$
946,676
$
1,052,785
TANDEM DIABETES CARE,
INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
Table B
(in thousands, except per
share data)
(Unaudited)
Three Months Ended June
30,
Six Months Ended June
30,
2023
2022
2023
2022
Sales
$
195,917
$
200,262
$
365,300
$
376,169
Cost of sales
94,182
98,316
180,658
183,130
Gross profit
101,735
101,946
184,642
193,039
Operating expenses:
Selling, general and administrative
97,610
80,614
187,424
153,885
Research and development
42,933
33,571
85,093
66,731
Acquired in-process research and
development expenses
—
—
78,750
—
Total operating expenses
140,543
114,185
351,267
220,616
Operating loss
(38,808
)
(12,239
)
(166,625
)
(27,577
)
Total other income (expense), net
4,179
(711
)
8,410
(1,812
)
Loss before income taxes
(34,629
)
(12,950
)
(158,215
)
(29,389
)
Income tax expense
1,146
2,106
1,433
382
Net loss
$
(35,775
)
$
(15,056
)
$
(159,648
)
$
(29,771
)
Net loss per share - basic
$
(0.55
)
$
(0.23
)
$
(2.47
)
$
(0.47
)
Net loss per share - diluted
$
(0.55
)
$
(0.24
)
$
(2.47
)
$
(0.47
)
Weighted average shares used to compute
basic and net loss per share
64,830
64,077
64,690
63,979
Weighted average shares used to compute
diluted net loss per share
64,830
64,078
64,690
63,980
TANDEM DIABETES CARE,
INC.
SALES BY GEOGRAPHY
Table C(1)
(Unaudited)
($'s in thousands)
Three Months Ended June
30,
Six Months Ended June
30,
2023
2022
% Change
2023
2022
% Change
United States:
Pump
$
74,360
$
81,656
(9
)%
$
140,816
$
155,153
(9
)%
Supplies and other
70,450
64,011
10
%
137,259
121,797
13
%
Deferral for Tandem Choice
(2,309
)
—
—
%
(4,332
)
—
—
%
Total GAAP Sales in the United States
$
142,501
$
145,667
(2
)%
$
273,743
$
276,950
(1
)%
Adjustment for Tandem Choice
2,309
—
—
%
4,332
—
—
%
Total Non-GAAP Sales in the United
States
$
144,810
$
145,667
(1
)%
$
278,075
$
276,950
—
%
Outside the United States:
Pump
$
27,317
$
25,798
6
%
$
45,563
$
48,130
(5
)%
Supplies and other
26,099
28,797
(9
)%
45,994
51,089
(10
)%
Total Sales Outside the United States
$
53,416
$
54,595
(2
)%
$
91,557
$
99,219
(8
)%
Total GAAP Worldwide Sales
$
195,917
$
200,262
(2
)%
$
365,300
$
376,169
(3
)%
Adjustment for Tandem Choice
2,309
—
—
%
4,332
—
—
%
Total Non-GAAP Worldwide Sales
$
198,226
$
200,262
(1
)%
$
369,632
$
376,169
(2
)%
(1)
A reconciliation of non-GAAP
financial measures to their closest GAAP equivalent and additional
information can be found in Table E and under the heading
“Reconciliation of GAAP versus Non-GAAP Financial Results.”
TANDEM DIABETES CARE,
INC.
PUMP SHIPMENTS
Table D
Three Months Ended June
30,
Six Months Ended June
30,
2023
2022
% Change
2023
2022
% Change
Pumps Shipped:
United States
18,964
20,818
(9
)%
35,967
39,476
(9
)%
Outside the United States
10,530
11,296
(7
)%
16,582
20,733
(20
)%
Total Pumps Shipped
29,494
32,114
(8
)%
52,549
60,209
(13
)%
TANDEM DIABETES CARE,
INC.
Reconciliation of GAAP versus
Non-GAAP Financial Results (Unaudited)
Table E
($'s in thousands)
Three Months Ended June
30,
Six Months Ended June
30,
2023
2022
2023
2022
GAAP sales
$
195,917
$
200,262
$
365,300
$
376,169
Adjustment for Tandem Choice (1)
2,309
—
4,332
—
Non-GAAP sales
$
198,226
$
200,262
$
369,632
$
376,169
GAAP gross profit
$
101,735
$
101,946
$
184,642
$
193,039
Adjustment for Tandem Choice(1)
2,309
—
4,332
—
Non-GAAP gross profit
$
104,044
$
101,946
$
188,974
$
193,039
Non-GAAP gross margin(2)
52
%
51
%
51
%
51
%
GAAP operating loss
$
(38,808
)
$
(12,239
)
$
(166,625
)
$
(27,577
)
Acquired in-process research and
development(3)
—
—
78,750
—
Non-recurring facility consolidation
costs(4)
14,099
—
14,099
—
Severance costs - cash and noncash
—
—
2,680
—
Adjustment for Tandem Choice(1)
2,309
—
4,332
—
Non-GAAP operating loss
$
(22,400
)
$
(12,239
)
$
(66,764
)
$
(27,577
)
Non-GAAP operating margin(2)
(11
)%
(6
)%
(18
)%
(7
)%
GAAP net loss
$
(35,775
)
$
(15,056
)
$
(159,648
)
$
(29,771
)
Income tax expense
1,146
2,106
1,433
382
Interest income and other, net
(5,784
)
(826
)
(11,649
)
(1,241
)
Interest expense
1,605
1,537
3,239
3,053
Depreciation and amortization
4,265
3,553
7,661
7,181
Stock-based compensation expense
23,400
20,131
44,205
38,241
Acquired in-process research and
development(3)
—
—
78,750
—
Non-recurring facility consolidation
costs(4)
14,099
—
14,099
—
Severance costs - cash and noncash
—
—
2,680
—
Adjustment for Tandem Choice(1)
2,309
—
4,332
—
Adjusted EBITDA
$
5,265
$
11,445
$
(14,898
)
$
17,845
Adjusted EBITDA margin(2)
3
%
6
%
(4
)%
5
%
GAAP net loss
$
(35,775
)
$
(15,056
)
$
(159,648
)
$
(29,771
)
Acquired in-process research and
development(3)
—
—
78,750
—
Non-recurring facility consolidation
costs(4)
14,099
—
14,099
—
Severance costs - cash and noncash
—
—
2,680
—
Adjustment for Tandem Choice(1)
2,309
—
4,332
—
Non-GAAP net loss
$
(19,367
)
$
(15,056
)
$
(59,787
)
$
(29,771
)
(1)
The accounting treatment for
Tandem Choice has a high degree of complexity. Additional
information can be found under the heading “Non-GAAP Financial
Measures.”
(2)
Non-GAAP margins including
non-GAAP gross margin, non-GAAP operating margin, and adjusted
EBITDA margin are calculated using non-GAAP sales.
(3)
The Company recorded a $78.8
million charge representing the value of acquired in-process
research and development assets with no alternative future use and
acquisition related expenses.
(4)
The Company recorded $14.1
million of facility consolidation costs related to our Vista
Sorrento lease in San Diego, California.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230803082124/en/
Media Contact: 858-255-6388 media@tandemdiabetes.com
Investor Contact: 858-366-6900 IR@tandemdiabetes.com
Grafico Azioni Tandem Diabetes Care (NASDAQ:TNDM)
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Da Mag 2024 a Giu 2024
Grafico Azioni Tandem Diabetes Care (NASDAQ:TNDM)
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