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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Tandem Diabetes Care Inc | NASDAQ:TNDM | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 36.20 | 36.50 | 39.47 | 0 | 13:31:50 |
|
☒
|
QUARTERLY 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
|
Delaware
|
|
20-4327508
|
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification No.)
|
|
11075 Roselle Street
|
|
92121
|
|
San Diego
|
California
|
|
(Zip Code)
|
(Address of principal executive offices)
|
|
|
Title of Each Class
|
Symbol
|
Name of Exchange on Which Registered
|
Common Stock, par value $0.001 per share
|
TNDM
|
NASDAQ Global Market
|
Large accelerated filer
|
x
|
|
Accelerated filer
|
☐
|
Non-accelerated filer
|
☐
|
|
Smaller reporting company
|
☐
|
|
|
|
Emerging growth company
|
☐
|
|
|
||
|
||
|
||
|
||
|
||
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
2019
|
|
2018
|
||||
|
(Unaudited)
|
|
(Note 1)
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
46,060
|
|
|
$
|
41,826
|
|
Short-term investments
|
110,887
|
|
|
87,201
|
|
||
Accounts receivable, net
|
45,325
|
|
|
35,193
|
|
||
Inventories, net
|
40,732
|
|
|
19,896
|
|
||
Prepaid and other current assets
|
3,594
|
|
|
3,769
|
|
||
Total current assets
|
246,598
|
|
|
187,885
|
|
||
Property and equipment, net
|
28,072
|
|
|
17,151
|
|
||
Operating lease right-of-use assets
|
16,577
|
|
|
—
|
|
||
Patents, net
|
885
|
|
|
1,130
|
|
||
Other long-term assets
|
515
|
|
|
128
|
|
||
Total assets
|
$
|
292,647
|
|
|
$
|
206,294
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
16,314
|
|
|
$
|
6,824
|
|
Accrued expenses
|
7,978
|
|
|
3,930
|
|
||
Employee-related liabilities
|
28,207
|
|
|
24,030
|
|
||
Deferred revenue
|
8,187
|
|
|
4,600
|
|
||
Common stock warrants
|
23,283
|
|
|
17,926
|
|
||
Operating lease liabilities
|
5,951
|
|
|
—
|
|
||
Other current liabilities
|
10,346
|
|
|
8,978
|
|
||
Total current liabilities
|
100,266
|
|
|
66,288
|
|
||
Deferred rent - long-term
|
—
|
|
|
3,799
|
|
||
Operating lease liabilities - long-term
|
15,258
|
|
|
—
|
|
||
Other long-term liabilities
|
10,129
|
|
|
4,932
|
|
||
Total liabilities
|
125,653
|
|
|
75,019
|
|
||
Commitments and contingencies (Note 9)
|
|
|
|
|
|
||
Stockholders’ equity:
|
|
|
|
||||
Common stock, $0.001 par value; 200,000 shares authorized, 59,029 and 57,554 shares issued and outstanding at September 30, 2019 (unaudited) and December 31, 2018, respectively.
|
59
|
|
|
57
|
|
||
Additional paid-in capital
|
794,324
|
|
|
731,306
|
|
||
Accumulated other comprehensive income (loss)
|
91
|
|
|
(13
|
)
|
||
Accumulated deficit
|
(627,480
|
)
|
|
(600,075
|
)
|
||
Total stockholders’ equity
|
166,994
|
|
|
131,275
|
|
||
Total liabilities and stockholders’ equity
|
$
|
292,647
|
|
|
$
|
206,294
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Sales
|
$
|
94,657
|
|
|
$
|
46,264
|
|
|
$
|
253,907
|
|
|
$
|
107,667
|
|
Cost of sales
|
43,974
|
|
|
24,468
|
|
|
119,967
|
|
|
59,381
|
|
||||
Gross profit
|
50,683
|
|
|
21,796
|
|
|
133,940
|
|
|
48,286
|
|
||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Selling, general and administrative
|
44,649
|
|
|
29,506
|
|
|
120,173
|
|
|
73,048
|
|
||||
Research and development
|
12,038
|
|
|
7,999
|
|
|
32,632
|
|
|
20,430
|
|
||||
Total operating expenses
|
56,687
|
|
|
37,505
|
|
|
152,805
|
|
|
93,478
|
|
||||
Operating loss
|
(6,004
|
)
|
|
(15,709
|
)
|
|
(18,865
|
)
|
|
(45,192
|
)
|
||||
Other income (expense), net:
|
|
|
|
|
|
|
|
||||||||
Interest and other income
|
914
|
|
|
443
|
|
|
2,457
|
|
|
833
|
|
||||
Interest and other expense
|
(60
|
)
|
|
(1,401
|
)
|
|
(76
|
)
|
|
(7,585
|
)
|
||||
Loss on extinguishment of debt
|
—
|
|
|
(5,313
|
)
|
|
—
|
|
|
(5,313
|
)
|
||||
Change in fair value of stock warrants
|
2,321
|
|
|
(12,265
|
)
|
|
(10,849
|
)
|
|
(69,042
|
)
|
||||
Total other income (expense), net
|
3,175
|
|
|
(18,536
|
)
|
|
(8,468
|
)
|
|
(81,107
|
)
|
||||
Loss before income taxes
|
(2,829
|
)
|
|
(34,245
|
)
|
|
(27,333
|
)
|
|
(126,299
|
)
|
||||
Income tax expense
|
72
|
|
|
—
|
|
|
72
|
|
|
—
|
|
||||
Net loss
|
$
|
(2,901
|
)
|
|
$
|
(34,245
|
)
|
|
$
|
(27,405
|
)
|
|
$
|
(126,299
|
)
|
Other comprehensive loss:
|
|
|
|
|
|
|
|
||||||||
Unrealized gain (loss) on short-term investments
|
$
|
(60
|
)
|
|
$
|
(19
|
)
|
|
$
|
91
|
|
|
$
|
(13
|
)
|
Foreign currency translation gain (loss)
|
(11
|
)
|
|
—
|
|
|
13
|
|
|
—
|
|
||||
Comprehensive loss
|
$
|
(2,972
|
)
|
|
$
|
(34,264
|
)
|
|
$
|
(27,301
|
)
|
|
$
|
(126,312
|
)
|
|
|
|
|
|
|
|
|
||||||||
Net loss per share, basic
|
$
|
(0.05
|
)
|
|
$
|
(0.62
|
)
|
|
$
|
(0.47
|
)
|
|
$
|
(2.81
|
)
|
Net loss per share, diluted
|
$
|
(0.09
|
)
|
|
$
|
(0.62
|
)
|
|
$
|
(0.47
|
)
|
|
$
|
(2.81
|
)
|
|
|
|
|
|
|
|
|
||||||||
Weighted average shares used to compute basic net loss per share
|
58,801
|
|
|
55,615
|
|
|
58,268
|
|
|
44,993
|
|
||||
Weighted average shares used to compute diluted net loss per share
|
59,196
|
|
|
55,615
|
|
|
58,268
|
|
|
44,993
|
|
|
Common Stock
|
|
Additional
Paid-in Capital |
|
Accumulated
Other Comprehensive Income (Loss) |
|
Accumulated
Deficit |
|
Total
Stockholders’ Equity |
|||||||||||||
|
Shares
|
|
Amount
|
|||||||||||||||||||
Balance at June 30, 2019
|
58,589
|
|
|
$
|
58
|
|
|
$
|
769,704
|
|
|
$
|
162
|
|
|
$
|
(624,579
|
)
|
|
$
|
145,345
|
|
Exercise of stock options
|
440
|
|
|
1
|
|
|
7,033
|
|
|
—
|
|
|
—
|
|
|
7,034
|
|
|||||
Fair value of common stock warrants at time of exercise
|
—
|
|
|
—
|
|
|
13
|
|
|
—
|
|
|
—
|
|
|
13
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
17,574
|
|
|
—
|
|
|
—
|
|
|
17,574
|
|
|||||
Foreign currency translation
|
—
|
|
|
—
|
|
|
—
|
|
|
(11
|
)
|
|
—
|
|
|
(11
|
)
|
|||||
Unrealized loss on short-term investments
|
—
|
|
|
—
|
|
|
—
|
|
|
(60
|
)
|
|
—
|
|
|
(60
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,901
|
)
|
|
(2,901
|
)
|
|||||
Balance at September 30, 2019
|
59,029
|
|
|
$
|
59
|
|
|
$
|
794,324
|
|
|
$
|
91
|
|
|
$
|
(627,480
|
)
|
|
$
|
166,994
|
|
|
Common Stock
|
|
Additional
Paid-in Capital |
|
Accumulated
Other Comprehensive Income (Loss) |
|
Accumulated
Deficit |
|
Total
Stockholders’ Equity |
|||||||||||||
|
Shares
|
|
Amount
|
|||||||||||||||||||
Balance at December 31, 2018
|
57,554
|
|
|
$
|
57
|
|
|
$
|
731,306
|
|
|
$
|
(13
|
)
|
|
$
|
(600,075
|
)
|
|
$
|
131,275
|
|
Exercise of stock options
|
1,214
|
|
|
2
|
|
|
14,510
|
|
|
—
|
|
|
—
|
|
|
14,512
|
|
|||||
Exercise of common stock warrants
|
93
|
|
|
—
|
|
|
326
|
|
|
—
|
|
|
—
|
|
|
326
|
|
|||||
Issuance of common stock for Employee Stock Purchase Plan
|
168
|
|
|
—
|
|
|
2,951
|
|
|
—
|
|
|
—
|
|
|
2,951
|
|
|||||
Fair value of common stock warrants at time of exercise
|
—
|
|
|
—
|
|
|
5,492
|
|
|
—
|
|
|
—
|
|
|
5,492
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
39,739
|
|
|
—
|
|
|
—
|
|
|
39,739
|
|
|||||
Foreign currency translation
|
—
|
|
|
—
|
|
|
—
|
|
|
13
|
|
|
—
|
|
|
13
|
|
|||||
Unrealized gain on short-term investments
|
—
|
|
|
—
|
|
|
—
|
|
|
91
|
|
|
—
|
|
|
91
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(27,405
|
)
|
|
(27,405
|
)
|
|||||
Balance at September 30, 2019
|
59,029
|
|
|
$
|
59
|
|
|
$
|
794,324
|
|
|
$
|
91
|
|
|
$
|
(627,480
|
)
|
|
$
|
166,994
|
|
|
Common Stock
|
|
Additional
Paid-in Capital |
|
Accumulated
Other Comprehensive Income (Loss) |
|
Accumulated
Deficit |
|
Total
Stockholders’ Equity |
|||||||||||||
|
Shares
|
|
Amount
|
|||||||||||||||||||
Balance at June 30, 2018
|
53,186
|
|
|
$
|
53
|
|
|
$
|
595,463
|
|
|
$
|
6
|
|
|
$
|
(569,518
|
)
|
|
$
|
26,004
|
|
Issuance of common stock in public offering, net of underwriter’s discount and offering costs
|
4,035
|
|
|
4
|
|
|
108,916
|
|
|
|
|
|
|
|
|
108,920
|
|
|||||
Exercise of stock options
|
31
|
|
|
—
|
|
|
467
|
|
|
|
|
|
|
|
|
467
|
|
|||||
Exercise of common stock warrants
|
112
|
|
|
—
|
|
|
393
|
|
|
|
|
|
|
|
|
393
|
|
|||||
Fair value of common stock warrants at time of exercise
|
—
|
|
|
—
|
|
|
3,913
|
|
|
|
|
|
|
|
|
3,913
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
9,996
|
|
|
|
|
|
|
|
|
9,996
|
|
|||||
Unrealized loss on short-term investments
|
—
|
|
|
—
|
|
|
|
|
|
(19
|
)
|
|
|
|
|
(19
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
|
|
|
|
|
|
(34,245
|
)
|
|
(34,245
|
)
|
|||||
Balance at September 30, 2018
|
57,364
|
|
|
$
|
57
|
|
|
$
|
719,148
|
|
|
$
|
(13
|
)
|
|
$
|
(603,763
|
)
|
|
$
|
115,429
|
|
|
Common Stock
|
|
Additional
Paid-in Capital |
|
Accumulated
Other Comprehensive Income (Loss) |
|
Accumulated
Deficit |
|
Total
Stockholders’ Equity (Deficit) |
|||||||||||||
|
Shares
|
|
Amount
|
|||||||||||||||||||
Balance at December 31, 2017
|
10,119
|
|
|
$
|
10
|
|
|
$
|
448,455
|
|
|
$
|
—
|
|
|
$
|
(477,614
|
)
|
|
$
|
(29,149
|
)
|
Adjustment to retained earnings from adoption of ASC 606
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
150
|
|
|
150
|
|
|||||
Issuance of common stock in public offering, net of underwriter’s discount and offering costs
|
38,535
|
|
|
39
|
|
|
172,890
|
|
|
—
|
|
|
—
|
|
|
172,929
|
|
|||||
Exercise of stock options
|
32
|
|
|
—
|
|
|
470
|
|
|
—
|
|
|
—
|
|
|
470
|
|
|||||
Exercise of common stock warrants
|
8,598
|
|
|
8
|
|
|
29,552
|
|
|
—
|
|
|
—
|
|
|
29,560
|
|
|||||
Fair value of common stock warrants at time of exercise
|
—
|
|
|
—
|
|
|
53,831
|
|
|
—
|
|
|
—
|
|
|
53,831
|
|
|||||
Stock-based compensation
|
80
|
|
|
—
|
|
|
13,950
|
|
|
—
|
|
|
—
|
|
|
13,950
|
|
|||||
Unrealized loss on short-term investments
|
—
|
|
|
—
|
|
|
—
|
|
|
(13
|
)
|
|
—
|
|
|
(13
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(126,299
|
)
|
|
(126,299
|
)
|
|||||
Balance at September 30, 2018
|
57,364
|
|
|
$
|
57
|
|
|
$
|
719,148
|
|
|
$
|
(13
|
)
|
|
$
|
(603,763
|
)
|
|
$
|
115,429
|
|
|
Nine Months Ended September 30,
|
||||||
|
2019
|
|
2018
|
||||
Operating activities
|
|
|
|
||||
Net loss
|
$
|
(27,405
|
)
|
|
$
|
(126,299
|
)
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
|
|
|
|
||||
Depreciation and amortization expense
|
4,430
|
|
|
4,353
|
|
||
Interest expense related to amortization of debt discount and debt issuance costs
|
—
|
|
|
1,721
|
|
||
Provision for allowance for doubtful accounts
|
1,468
|
|
|
1,017
|
|
||
Provision for inventories reserve
|
1,508
|
|
|
397
|
|
||
Change in fair value of common stock warrants
|
10,849
|
|
|
69,042
|
|
||
Amortization of premium (discount) on short-term investments
|
(302
|
)
|
|
783
|
|
||
Stock-based compensation expense
|
39,386
|
|
|
13,427
|
|
||
Loss on extinguishment of debt
|
—
|
|
|
5,313
|
|
||
Other
|
42
|
|
|
155
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable, net
|
(11,588
|
)
|
|
(1,913
|
)
|
||
Inventories, net
|
(21,990
|
)
|
|
2,752
|
|
||
Prepaid and other current assets
|
(17
|
)
|
|
(823
|
)
|
||
Other long-term assets
|
(387
|
)
|
|
(39
|
)
|
||
Accounts payable
|
7,131
|
|
|
1,083
|
|
||
Accrued expenses
|
4,045
|
|
|
1,098
|
|
||
Employee-related liabilities
|
4,173
|
|
|
2,741
|
|
||
Deferred revenue
|
3,587
|
|
|
1,178
|
|
||
Other current liabilities
|
2,335
|
|
|
1,100
|
|
||
Deferred rent
|
—
|
|
|
(571
|
)
|
||
Other long-term liabilities
|
5,198
|
|
|
1,033
|
|
||
Net cash provided by (used in) operating activities
|
22,463
|
|
|
(22,452
|
)
|
||
Investing activities
|
|
|
|
||||
Purchases of short-term investments
|
(126,307
|
)
|
|
(100,550
|
)
|
||
Proceeds from maturities of short-term investments
|
96,495
|
|
|
18,500
|
|
||
Proceeds from sales of short-term investments
|
6,550
|
|
|
—
|
|
||
Purchases of property and equipment
|
(12,792
|
)
|
|
(2,098
|
)
|
||
Net cash used in investing activities
|
(36,054
|
)
|
|
(84,148
|
)
|
||
Financing activities
|
|
|
|
||||
Principal payments on notes payable
|
—
|
|
|
(87,711
|
)
|
||
Proceeds from public offering, net of offering costs
|
—
|
|
|
172,929
|
|
||
Proceeds from exercise of common stock warrants
|
327
|
|
|
29,536
|
|
||
Proceeds from issuance of common stock under Company stock plans
|
17,462
|
|
|
473
|
|
||
Net cash provided by financing activities
|
17,789
|
|
|
115,227
|
|
||
Effect of foreign exchange rate changes on cash
|
36
|
|
|
—
|
|
||
Net increase in cash and cash equivalents and restricted cash
|
4,234
|
|
|
8,627
|
|
||
Cash and cash equivalents and restricted cash at beginning of period
|
41,826
|
|
|
23,700
|
|
||
Cash and cash equivalents at end of period
|
$
|
46,060
|
|
|
$
|
32,327
|
|
Supplemental disclosures of cash flow information
|
|
|
|
||||
Interest paid
|
$
|
—
|
|
|
$
|
5,841
|
|
Supplemental schedule of non-cash investing and financing activities
|
|
|
|
||||
Right-of-use assets obtained in exchange for operating lease obligations
|
$
|
11,445
|
|
|
$
|
—
|
|
Property and equipment included in accounts payable
|
$
|
2,484
|
|
|
$
|
57
|
|
Balance at December 31, 2018
|
$
|
9,138
|
|
Provision for warranties issued during the period
|
13,790
|
|
|
Settlements made during the period
|
(7,443
|
)
|
|
Increases in warranty estimates
|
607
|
|
|
Balance at September 30, 2019
|
$
|
16,092
|
|
|
|
||
Current portion
|
$
|
5,963
|
|
Non-current portion
|
10,129
|
|
|
Total
|
$
|
16,092
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||
Warrants to purchase common stock
|
293
|
|
|
710
|
|
|
710
|
|
|
710
|
|
Options to purchase common stock
|
6,234
|
|
|
5,155
|
|
|
5,868
|
|
|
3,031
|
|
Awards granted under the ESPP
|
134
|
|
|
61
|
|
|
45
|
|
|
24
|
|
|
6,661
|
|
|
5,926
|
|
|
6,623
|
|
|
3,765
|
|
At September 30, 2019
|
Maturity
(in years)
|
|
Amortized
Cost
|
|
Gross Unrealized
Gain
|
|
Gross Unrealized
Loss
|
|
Estimated
Fair Value
|
||||||||
Available-for-sale securities:
|
|
|
|
|
|
|
|
|
|
||||||||
Commercial paper
|
Less than 1
|
|
$
|
24,997
|
|
|
$
|
10
|
|
|
$
|
(3
|
)
|
|
$
|
25,004
|
|
U.S. Government-sponsored enterprise
|
Less than 2
|
|
21,830
|
|
|
9
|
|
|
(4
|
)
|
|
21,835
|
|
||||
U.S. Treasury securities
|
Less than 1
|
|
12,710
|
|
|
18
|
|
|
—
|
|
|
12,728
|
|
||||
Corporate debt securities
|
Less than 2
|
|
51,242
|
|
|
83
|
|
|
(5
|
)
|
|
51,320
|
|
||||
Total
|
|
|
$
|
110,779
|
|
|
$
|
120
|
|
|
$
|
(12
|
)
|
|
$
|
110,887
|
|
At December 31, 2018
|
Maturity
(in years)
|
|
Amortized
Cost
|
|
Unrealized
Gain
|
|
Unrealized
Loss
|
|
Estimated
Fair Value
|
||||||||
Available-for-sale securities:
|
|
|
|
|
|
|
|
|
|
||||||||
Commercial paper
|
Less than 1
|
|
$
|
53,559
|
|
|
$
|
—
|
|
|
$
|
(22
|
)
|
|
$
|
53,537
|
|
U.S. Treasury securities
|
Less than 1
|
|
17,937
|
|
|
—
|
|
|
(2
|
)
|
|
17,935
|
|
||||
Corporate debt securities
|
Less than 1
|
|
15,718
|
|
|
12
|
|
|
(1
|
)
|
|
15,729
|
|
||||
Total
|
|
|
$
|
87,214
|
|
|
$
|
12
|
|
|
$
|
(25
|
)
|
|
$
|
87,201
|
|
|
September 30,
2019 |
|
December 31,
2018 |
||||
Raw materials
|
$
|
12,488
|
|
|
$
|
6,622
|
|
Work-in-process
|
11,051
|
|
|
2,710
|
|
||
Finished goods
|
17,192
|
|
|
10,564
|
|
||
Total
|
$
|
40,732
|
|
|
$
|
19,896
|
|
Level 1:
|
Observable inputs such as unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.
|
Level 2:
|
Inputs, other than quoted prices in active markets, that are observable either directly or indirectly for substantially the full term of the asset or liability.
|
Level 3:
|
Unobservable inputs in which there is little or no market data and that are significant to the fair value of the assets or liabilities, which require the reporting entity to develop its own valuation techniques that require input assumptions.
|
|
|
|
Fair Value Measurements at
September 30, 2019 |
||||||||||||
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
|||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Cash equivalents(1)
|
$
|
37,987
|
|
|
$
|
37,987
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Commercial paper
|
25,004
|
|
|
—
|
|
|
25,004
|
|
|
—
|
|
||||
U.S. Government-sponsored enterprise
|
21,835
|
|
|
—
|
|
|
21,835
|
|
|
—
|
|
||||
U.S. Treasury securities
|
12,728
|
|
|
12,728
|
|
|
—
|
|
|
—
|
|
||||
Corporate debt securities
|
51,320
|
|
|
—
|
|
|
51,320
|
|
|
—
|
|
||||
Total assets
|
$
|
148,874
|
|
|
$
|
50,715
|
|
|
$
|
98,159
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
||||||||
Common stock warrants
|
$
|
23,283
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
23,283
|
|
Total liabilities
|
$
|
23,283
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
23,283
|
|
|
|
|
Fair Value Measurements at
December 31, 2018 |
||||||||||||
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
|||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Cash equivalents(1)
|
$
|
37,373
|
|
|
$
|
37,373
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Commercial paper
|
53,537
|
|
|
—
|
|
|
53,537
|
|
|
—
|
|
||||
U.S. Treasury securities
|
17,935
|
|
|
17,935
|
|
|
—
|
|
|
—
|
|
||||
Corporate debt securities
|
15,729
|
|
|
—
|
|
|
15,729
|
|
|
—
|
|
||||
Total assets
|
$
|
124,574
|
|
|
$
|
55,308
|
|
|
$
|
69,266
|
|
|
$
|
—
|
|
Liabilities
|
|
|
|
|
|
|
|
||||||||
Common stock warrants
|
$
|
17,926
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
17,926
|
|
Total liabilities
|
$
|
17,926
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
17,926
|
|
(1)
|
Generally, cash equivalents include money market funds and investments with a maturity of three months or less from the date of purchase.
|
|
September 30, 2019
|
|
December 31, 2018
|
||
Risk-free interest rate
|
1.6
|
%
|
|
3.0
|
%
|
Expected dividend yield
|
0.0
|
%
|
|
0.0
|
%
|
Expected volatility
|
83.3
|
%
|
|
78.3
|
%
|
Expected term (in years)
|
3.0
|
|
|
3.8
|
|
|
Nine Months Ended September 30,
|
||||||
|
2019
|
|
2018
|
||||
Balance at beginning of period
|
$
|
17,926
|
|
|
$
|
5,432
|
|
Increase in fair value included in change in fair value of common stock warrants
|
10,849
|
|
|
69,042
|
|
||
Decrease in fair value from warrants exercised during the period
|
(5,492
|
)
|
|
(53,831
|
)
|
||
Balance at end of period
|
$
|
23,283
|
|
|
$
|
20,643
|
|
Years Ending December 31,
|
|
|
||
2019 (remaining)
|
|
$
|
867
|
|
2020
|
|
6,831
|
|
|
2021
|
|
7,100
|
|
|
2022
|
|
5,880
|
|
|
2023
|
|
1,991
|
|
|
Thereafter
|
|
1,577
|
|
|
Total future minimum lease payments
|
|
24,246
|
|
|
Less: amount representing interest
|
|
(3,037
|
)
|
|
Present value of future minimum lease payments
|
|
21,209
|
|
|
Less: current portion of operating lease liabilities
|
|
(5,951
|
)
|
|
Operating lease liabilities - long-term
|
|
$
|
15,258
|
|
Shares underlying outstanding warrants
|
710
|
|
Shares underlying outstanding stock options
|
7,358
|
|
Shares authorized for future equity award grants
|
3,165
|
|
Shares authorized for issuance pursuant to awards granted under the ESPP
|
1,852
|
|
|
13,085
|
|
|
Stock Options
|
||||||||||||||
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|||||||||||||
2019
|
|
2018
|
|
2019
|
|
2018
|
|||||||||
Weighted average grant date fair value (per share)
|
$
|
38.74
|
|
|
$
|
21.77
|
|
|
$
|
39.08
|
|
|
$
|
12.35
|
|
Risk-free interest rate
|
1.7
|
%
|
|
2.8
|
%
|
|
2.1
|
%
|
|
2.8
|
%
|
||||
Expected dividend yield
|
0.0
|
%
|
|
0.0
|
%
|
|
0.0
|
%
|
|
0.0
|
%
|
||||
Expected volatility
|
71.8
|
%
|
|
70.5
|
%
|
|
71.8
|
%
|
|
71.4
|
%
|
||||
Expected term (in years)
|
6.1
|
|
|
6.1
|
|
|
6.0
|
|
|
5.7
|
|
|
ESPP
|
||||||
Nine Months Ended
September 30, |
|||||||
2019
|
|
2018
|
|||||
Weighted average grant date fair value (per share)
|
$
|
33.49
|
|
|
$
|
9.62
|
|
Risk-free interest rate
|
2.3
|
%
|
|
2.4
|
%
|
||
Expected dividend yield
|
0.0
|
%
|
|
0.0
|
%
|
||
Expected volatility
|
75.9
|
%
|
|
77.0
|
%
|
||
Expected term (in years)
|
1.3
|
|
|
1.3
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Cost of sales
|
$
|
1,751
|
|
|
$
|
784
|
|
|
$
|
4,178
|
|
|
$
|
1,129
|
|
Selling, general & administrative
|
13,110
|
|
|
6,821
|
|
|
29,060
|
|
|
9,833
|
|
||||
Research and development
|
2,369
|
|
|
1,932
|
|
|
6,148
|
|
|
2,465
|
|
||||
Total
|
$
|
17,230
|
|
|
$
|
9,537
|
|
|
$
|
39,386
|
|
|
$
|
13,427
|
|
•
|
t:slim X2 with Control-IQ technology – Our second-generation AID system integrates our t:slim X2 with the technology that we licensed from TypeZero Technologies, LLC (TypeZero) and Dexcom’s G6 CGM sensor. Our product is intended to both increase and decrease basal insulin based on a user’s predicted blood glucose levels from a compatible iCGM sensor, as well as deliver automated correction boluses. In conjunction with Dexcom and TypeZero, which was acquired by Dexcom in August 2018, we have integrated our technologies into the U.S. portion of the Clinical Acceptance of the Artificial Pancreas (DCLP3) portion of the International Diabetes Closed Loop (IDCL) trial. The 6-month study was completed in April 2019. In June 2019, positive results from this study were announced with significant time-in-range improvements. Subsequently, we filed a regulatory submission with the FDA for our t:slim X2 insulin pump with Control-IQ technology. Subject to FDA approval, our goal is to commence commercial sales of our t:slim X2 with Control-IQ technology in the United States in the fourth quarter of 2019. We are also awaiting the results of two studies using the t:slim X2 with Control-IQ technology in pediatric populations, which we intend to use to support a future regulatory submission for a lower age indication.
|
•
|
Connected (Mobile) Health Offerings – We are currently developing a mobile application that is being designed to utilize the capability of the Bluetooth radio integrated with the t:slim X2 to wirelessly upload pump data to t:connect, receive notification of pump alerts and alarms, integrate other health-related information from third party sources, and support future pump-control capabilities for our products under development.
|
◦
|
We are preparing to launch the first generation of this mobile application in the United States in conjunction with our Control-IQ technology, which will allow for the wireless upload of data to t:connect. The t:connect application is intended to reduce patient burden and increase healthcare provider office efficiency by reducing the manual steps historically required for data extraction.
|
◦
|
Over time, we also intend to offer additional features and enhancements to the mobile application.
|
•
|
t:sport Insulin Delivery System – Approximately half the size of our t:slim X2 pump, the t:sport pump is being designed for people who seek even greater discretion and flexibility with the use of their insulin pump. We anticipate that t:sport will feature a 200-unit cartridge, an on-pump bolus button, a rechargeable battery, an AID algorithm, and a Bluetooth radio. t:sport is being designed for use with leading U-100 insulins, and we are evaluating the use of insulin concentrates to provide to people with greater insulin needs. t:sport is expected to utilize a pumping mechanism that differs from our current Micro-Delivery technology. We anticipate that t:sport will be our first insulin pump to support full pump-control from our mobile application, subject to FDA review and approval. A separate controller may be offered in addition to or in advance of full mobile control availability.
|
|
Pump Units Shipped for Each of the Three Months Ended in Respective Years(1) - U.S.
|
|||||||||||||
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
|
Total
|
|||||
2012
|
—
|
|
|
9
|
|
|
204
|
|
|
844
|
|
|
1,057
|
|
2013
|
852
|
|
|
1,363
|
|
|
1,851
|
|
|
2,406
|
|
|
6,472
|
|
2014
|
1,723
|
|
|
2,235
|
|
|
2,935
|
|
|
3,929
|
|
|
10,822
|
|
2015
|
2,487
|
|
|
3,331
|
|
|
3,431
|
|
|
6,234
|
|
|
15,483
|
|
2016(2)
|
4,042
|
|
|
4,582
|
|
|
3,896
|
|
|
4,418
|
|
|
16,938
|
|
2017(2)
|
2,816
|
|
|
3,427
|
|
|
3,868
|
|
|
6,950
|
|
|
17,061
|
|
2018
|
4,444
|
|
|
5,447
|
|
|
7,379
|
|
|
12,935
|
|
|
30,205
|
|
2019
|
9,669
|
|
|
12,799
|
|
|
13,814
|
|
|
N/A
|
|
36,282
|
|
|
Pump Units Shipped for Each of the Three Months Ended in Respective Years(1) - International
|
|||||||||||||
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
|
Total
|
|||||
2018
|
N/A
|
|
N/A
|
|
1,055
|
|
|
3,233
|
|
|
4,288
|
|
||
2019
|
5,063
|
|
|
8,459
|
|
|
4,025
|
|
|
N/A
|
|
|
17,547
|
|
(1)
|
The pump units shipped do not reflect returns or exchanges of pump products that occur in the ordinary course of business.
|
(2)
|
2016 and 2017 U.S. shipments do not include approximately 3,300 pump trade-ins fulfilled under the Technology Upgrade Program related to our commercial launch of t:slim X2.
|
•
|
market acceptance of our products and competitive products by people with insulin-dependent diabetes, their caregivers and healthcare providers;
|
•
|
the introduction of new products, treatment techniques or technologies for the treatment of diabetes, including the timing of the commercialization of new products by us and our competitors;
|
•
|
seasonality in the United States associated with annual insurance deductibles and coinsurance requirements associated with the medical insurance plans utilized by our customers and the customers of our distributors;
|
•
|
timing of holidays and summer vacations, which may vary by geography;
|
•
|
the buying patterns of our distributors and other customers, both domestically and internationally;
|
•
|
changes in the competitive landscape, including as a result of companies entering or exiting the diabetes therapy market;
|
•
|
access to adequate coverage and reimbursement for our current and future products by third-party payors, and reimbursement decisions by third-party payors;
|
•
|
the magnitude and timing of any changes to our facilities, manufacturing operations and other infrastructure;
|
•
|
anticipated and actual regulatory approvals of our products and competitive products; and
|
•
|
product recalls impacting, or the suspension or withdrawal of regulatory clearance or approval relating to, our products or the products of our competitors.
|
•
|
continued increase in demand following the commercial launch of t:slim X2 and the demonstrated success of our Tandem Device Updater;
|
•
|
anticipated new product launches;
|
•
|
increased opportunity to achieve customer renewals as customers become eligible for insurance reimbursement to purchase a new insulin pump at the end of the typical four-year reimbursement cycle;
|
•
|
opportunity to attract customers of Animas Corporation (Animas) following the announcement by Johnson & Johnson that it discontinued the operations of Animas and discontinued availability of Animas pump supplies on September 30, 2019;
|
•
|
designation by UnitedHealthcare of one of our competitors as its preferred, in-network durable medical equipment provider of insulin pumps for most customers age seven and above;
|
•
|
ability to enter into and maintain agreements with CGM partners for CGM integration;
|
•
|
expansion and new product launches in select international geographies; and
|
•
|
ability to effectively scale our operations to support rapid growth, including expanding our facilities, increasing manufacturing capacity through third party manufacturers, and hiring and retaining employees in the customer service and support functions.
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(in thousands, except percentages)
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Sales:
|
|
|
|
|
|
|
|
||||||||
Domestic
|
$
|
78,842
|
|
|
$
|
43,720
|
|
|
$
|
203,867
|
|
|
$
|
105,123
|
|
International
|
15,815
|
|
|
2,544
|
|
|
50,040
|
|
|
2,544
|
|
||||
Total sales
|
94,657
|
|
|
46,264
|
|
|
253,907
|
|
|
107,667
|
|
||||
Cost of sales
|
43,974
|
|
|
24,468
|
|
|
119,967
|
|
|
59,381
|
|
||||
Gross profit
|
50,683
|
|
|
21,796
|
|
|
133,940
|
|
|
48,286
|
|
||||
Gross margin
|
54
|
%
|
|
47
|
%
|
|
53
|
%
|
|
45
|
%
|
||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Selling, general and administrative
|
44,649
|
|
|
29,506
|
|
|
120,173
|
|
|
73,048
|
|
||||
Research and development
|
12,038
|
|
|
7,999
|
|
|
32,632
|
|
|
20,430
|
|
||||
Total operating expenses
|
56,687
|
|
|
37,505
|
|
|
152,805
|
|
|
93,478
|
|
||||
Operating loss
|
(6,004
|
)
|
|
(15,709
|
)
|
|
(18,865
|
)
|
|
(45,192
|
)
|
||||
Other income (expense), net:
|
|
|
|
|
|
|
|
||||||||
Interest and other income
|
914
|
|
|
443
|
|
|
2,457
|
|
|
833
|
|
||||
Interest and other expense
|
(60
|
)
|
|
(1,401
|
)
|
|
(76
|
)
|
|
(7,585
|
)
|
||||
Loss on extinguishment of debt
|
—
|
|
|
(5,313
|
)
|
|
—
|
|
|
(5,313
|
)
|
||||
Change in fair value of stock warrants
|
2,321
|
|
|
(12,265
|
)
|
|
(10,849
|
)
|
|
(69,042
|
)
|
||||
Total other income (expense), net
|
3,175
|
|
|
(18,536
|
)
|
|
(8,468
|
)
|
|
(81,107
|
)
|
||||
Loss before income taxes
|
(2,829
|
)
|
|
(34,245
|
)
|
|
(27,333
|
)
|
|
(126,299
|
)
|
||||
Income tax expense
|
72
|
|
|
—
|
|
|
72
|
|
|
—
|
|
||||
Net loss
|
$
|
(2,901
|
)
|
|
$
|
(34,245
|
)
|
|
$
|
(27,405
|
)
|
|
$
|
(126,299
|
)
|
|
Three Months Ended
September 30, |
||||||
|
2019
|
|
2018
|
||||
Pump
|
$
|
10,310
|
|
|
$
|
2,217
|
|
Infusion sets
|
3,444
|
|
|
67
|
|
||
Cartridges
|
2,018
|
|
|
228
|
|
||
Other
|
43
|
|
|
32
|
|
||
Total International Sales
|
$
|
15,815
|
|
|
$
|
2,544
|
|
|
Nine Months Ended
September 30, |
||||||
|
2019
|
|
2018
|
||||
Pump
|
$
|
36,472
|
|
|
$
|
2,217
|
|
Infusion sets
|
8,225
|
|
|
67
|
|
||
Cartridges
|
5,130
|
|
|
228
|
|
||
Other
|
213
|
|
|
32
|
|
||
Total International Sales
|
$
|
50,040
|
|
|
$
|
2,544
|
|
•
|
In February 2018, we completed a registered public offering of 34,500,000 shares of common stock at a public offering price of $2.00 per share. The gross proceeds from the offering were approximately $69.0 million, before deducting underwriting discounts and commissions and other offering expenses.
|
•
|
In August 2018, we completed a registered public offering of 4,035,085 shares of common stock at a public offering price of $28.50 per share. The gross proceeds from the offering were $115.0 million, before deducting underwriting discounts and commissions and other offering expenses.
|
•
|
Between January 2018 and September 2019, we received proceeds of $29.9 million from the exercise of 8,829,235 outstanding warrants which were originally issued in a registered public offering of common stock in October 2017. As of September 30, 2019, there were warrants to purchase 417,315 shares outstanding relating to the October 2017 offering.
|
•
|
Between January 2018 and September 2019, we issued 1,349,470 shares of common stock upon the exercise of stock options, and 248,746 shares of common stock were purchased under our 2013 Employee Stock Purchase Plan, which generated aggregate proceeds of $20.2 million.
|
|
Nine Months Ended
September 30, |
||||||
(in thousands)
|
2019
|
|
2018
|
||||
Net cash provided by (used in):
|
|
|
|
||||
Operating activities
|
$
|
22,463
|
|
|
$
|
(22,452
|
)
|
Investing activities
|
(36,054
|
)
|
|
(84,148
|
)
|
||
Financing activities
|
17,789
|
|
|
115,227
|
|
||
Effect of foreign exchange rate changes on cash
|
36
|
|
|
—
|
|
||
Total
|
$
|
4,234
|
|
|
$
|
8,627
|
|
•
|
our ability to generate sales, the timing of those sales, the mix of products sold and the collection of receivables from period to period;
|
•
|
the timing of any additional financings, and the net proceeds raised from such financings;
|
•
|
the timing and amount of the exercise of outstanding warrants, and proceeds from the issuance of equity awards pursuant to employee stock plans;
|
•
|
fluctuations in gross margins and operating margins; and
|
•
|
fluctuations in working capital, including changes in accounts receivable, inventories, accounts payable, employee related liabilities, and operating lease liabilities.
|
•
|
support of our commercialization efforts related to our current and future products;
|
•
|
expansion of our customer support resources for our growing installed customer base;
|
•
|
research and product development efforts, including clinical trial costs;
|
•
|
acquisitions of equipment, technology, intellectual property and other assets;
|
•
|
additional facilities leases and related tenant improvements, and manufacturing equipment to support business growth and increase manufacturing capacity; and
|
•
|
payments under licensing, development and commercialization agreements.
|
Item 1.
|
Legal Proceedings
|
Item 1A.
|
Risk Factors
|
•
|
market acceptance of the insulin pumps and related products manufactured and sold by our key competitors, including Medtronic Public Limited Company (plc) (Medtronic);
|
•
|
the potential that breakthroughs for the monitoring, treatment or prevention of diabetes may render our insulin pumps obsolete or less desirable;
|
•
|
adverse regulatory or legal actions relating to our products, or similar products or technologies of our competitors;
|
•
|
failure of our Tandem Device Updater to accurately and timely provide customers with remote access to new product features and functionality as anticipated, or our failure to obtain regulatory approval for any such updates;
|
•
|
changes in reimbursement rates or policies relating to insulin pumps or similar products or technologies by third-party payors, such as the decision by UnitedHealthcare that restricts a majority of its members from accessing our pumps;
|
•
|
our inability to enter into contracts with third-party payors on a timely basis and on acceptable terms;
|
•
|
problems arising from the expansion of our manufacturing capabilities and commercial operations, or destruction, loss, or temporary shutdown of our manufacturing facilities;
|
•
|
concerns regarding the perceived safety or reliability of any of our products, or any component thereof; and
|
•
|
claims that any of our products, or any component thereof, infringes on patent rights or other intellectual property rights of third parties.
|
•
|
greater financial and human resources for sales and marketing, product development, customer service and clinical resources;
|
•
|
greater ability to respond to competitive pressures and regulatory uncertainty;
|
•
|
established relationships with healthcare providers, third-party payors and regulatory agencies;
|
•
|
established reputation and name recognition among healthcare providers and other key opinion leaders in the medical industry generally and the diabetes industry in particular;
|
•
|
greater market share and established base of customers;
|
•
|
products supported by long-term clinical data;
|
•
|
larger and more established distribution networks;
|
•
|
greater ability to cross-sell products or provide incentives to healthcare providers to use their products; and
|
•
|
more experience in conducting research and development, manufacturing, clinical trials, and obtaining regulatory approval or clearance.
|
•
|
the failure of our products to achieve and maintain wide acceptance among people with insulin-dependent diabetes, their caregivers, healthcare providers, third-party payors and key opinion leaders in the diabetes treatment community;
|
•
|
lack of evidence supporting the safety, ease-of-use or other perceived benefits of our products over competitive products or other currently-available insulin treatment methodologies;
|
•
|
perceived risks or uncertainties associated with the use of our products, or components thereof, or of similar products or technologies of our competitors;
|
•
|
adverse regulatory or legal actions relating to our insulin pump products or similar products or technologies; and
|
•
|
results of clinical studies relating to our existing products or products under development or similar competitive products.
|
•
|
implement and execute our business strategy;
|
•
|
manage and improve the productivity of our sales, clinical, marketing and customer service infrastructure to grow sales of our existing and proposed products, and enhance our ability to provide service and support to our customers;
|
•
|
achieve and maintain market acceptance of our products and increase awareness of our brand among people with insulin-dependent diabetes, their caregivers and healthcare providers;
|
•
|
comply with a broad range of regulatory requirements within a highly regulated industry;
|
•
|
enhance our manufacturing capabilities, increase production of products efficiently while maintaining quality standards, and adapt our manufacturing facilities to the production of new products;
|
•
|
respond effectively to competitive pressures and developments;
|
•
|
enhance our existing products and develop proposed products;
|
•
|
obtain and maintain regulatory clearance or approval to enhance our existing products and commercialize proposed products;
|
•
|
perform clinical trials with respect to our existing products and proposed products; and
|
•
|
attract, retain and motivate qualified personnel in various areas of our business.
|
•
|
quality or reliability defects in product components that we source from third-party suppliers;
|
•
|
our inability to secure product components in a timely manner, in sufficient quantities and on commercially reasonable terms;
|
•
|
difficulty identifying and qualifying alternative suppliers for components in a timely manner;
|
•
|
implementing and maintaining acceptable quality systems while experiencing rapid growth;
|
•
|
our failure to increase production of products to meet demand;
|
•
|
our inability to modify production lines and expand manufacturing facilities to enable us to efficiently produce future products or implement changes in current products in response to consumer demand or regulatory requirements;
|
•
|
our inability to manufacture multiple products simultaneously while utilizing common manufacturing equipment; and
|
•
|
potential damage to or destruction of our manufacturing equipment or manufacturing facilities.
|
•
|
identify the product features and functionality that people with insulin-dependent diabetes, their caregivers and healthcare providers are seeking in an insulin pump, and successfully incorporate those features into our products;
|
•
|
develop and introduce products in sufficient quantities and in a timely manner;
|
•
|
offer products at a price that is competitive with other products then available;
|
•
|
work with third-party payors to obtain reimbursement for our products;
|
•
|
adequately protect our intellectual property and avoid infringing upon the intellectual property rights of third parties;
|
•
|
demonstrate the safety and efficacy of proposed products; and
|
•
|
obtain the necessary regulatory approvals for proposed products.
|
•
|
different regulatory requirements for product approvals in foreign countries;
|
•
|
differing U.S. and foreign medical device import and export rules;
|
•
|
more restrictive privacy laws relating to personal information of end users and employees, including GDPR;
|
•
|
reduced protection for our intellectual property rights in foreign countries;
|
•
|
unexpected changes in tariffs, trade barriers and regulatory requirements;
|
•
|
different reimbursement systems;
|
•
|
economic weakness, including inflation, or political instability in particular foreign economies and markets;
|
•
|
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad or with U.S. regulations that would apply to activities in such foreign jurisdictions, such as the U.S. Foreign Corrupt Practices Act;
|
•
|
foreign taxes, including withholding of payroll taxes;
|
•
|
foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; and
|
•
|
business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters.
|
•
|
problems assimilating the acquired products or technologies;
|
•
|
issues maintaining uniform standards, procedures, controls and policies;
|
•
|
unanticipated costs associated with acquisitions;
|
•
|
diversion of management’s attention from our existing business;
|
•
|
risks associated with entering new markets in which we have limited or no experience; and
|
•
|
increased legal and accounting costs relating to the acquisitions or to compliance with regulatory matters.
|
•
|
the revenue generated by sales of our insulin pump products, and the related insulin cartridges and infusion sets, and any other future products that we may develop and commercialize;
|
•
|
the gross profits and gross margin we realize from the sales we generate;
|
•
|
the costs associated with maintaining and expanding an appropriate sales, clinical and marketing infrastructure;
|
•
|
the expenses we incur or other capital expenditures we make to maintain or enhance our manufacturing operations, including leasing additional property, hiring additional personnel, purchasing additional manufacturing equipment, and other measures taken to add manufacturing capacity;
|
•
|
the expenses associated with developing and commercializing our proposed products or technologies;
|
•
|
the costs associated with maintaining and expanding our customer service infrastructure;
|
•
|
the cost of obtaining and maintaining regulatory clearance or approval for our products and our manufacturing facilities;
|
•
|
the cost of ongoing compliance with legal and regulatory requirements;
|
•
|
the expenses we incur in connection with potential litigation or governmental investigations;
|
•
|
expenses we may incur or other financial commitments we may make in connection with current and potential new business or commercial collaborations, development agreements or licensing arrangements;
|
•
|
anticipated or unanticipated capital expenditures; and
|
•
|
unanticipated general and administrative expenses.
|
•
|
our ability to increase sales and gross profit from our insulin pump products, including the related insulin cartridges and infusion sets, and to commercialize and sell our future products;
|
•
|
the number and mix of our products sold in each quarter;
|
•
|
acceptance of our products by people with insulin-dependent diabetes, their caregivers, healthcare providers and third-party payors;
|
•
|
the pricing of our products and competitive products, including the use of discounts, rebates or other financial incentives by us or our competitors;
|
•
|
the effect of third-party coverage and reimbursement policies;
|
•
|
our ability to maintain our existing infrastructure;
|
•
|
the amount of, and the timing of the payment for, insurance deductibles required to be paid by our customers and potential customers under their existing insurance plans;
|
•
|
interruption in the manufacturing or distribution of our products;
|
•
|
our ability to simultaneously manufacture multiple products that meet quality, reliability and regulatory requirements;
|
•
|
seasonality and other factors affecting the timing of purchases of our products;
|
•
|
timing of new product offerings, acquisitions, licenses or other significant events by us or our competitors;
|
•
|
results of clinical research and trials on our existing and future products;
|
•
|
the ability of our suppliers to timely provide us with an adequate supply of components that meet our requirements for product quality and reliability;
|
•
|
regulatory clearance or approvals affecting our products or those of our competitors; and
|
•
|
the timing of revenue and expense recognition associated with our product sales pursuant to applicable accounting standards.
|
•
|
stop selling our products or using technology that contains the allegedly infringing intellectual property;
|
•
|
prevent or limit our ability to sell a product that we are currently developing;
|
•
|
incur significant legal expenses;
|
•
|
pay substantial damages to the party whose intellectual property rights we are allegedly infringing;
|
•
|
redesign those products that contain the allegedly infringing intellectual property; or
|
•
|
attempt to obtain a license to the relevant intellectual property from third parties, which may not be available on reasonable terms or at all.
|
•
|
product design and development;
|
•
|
pre-clinical and clinical testing and trials;
|
•
|
product safety;
|
•
|
establishment registration and product listing;
|
•
|
labeling and storage;
|
•
|
marketing, manufacturing, sales and distribution;
|
•
|
pre-market clearance or approval;
|
•
|
servicing and post-market surveillance;
|
•
|
advertising and promotion; and
|
•
|
recalls and field safety corrective actions.
|
•
|
our inability to demonstrate that our products are safe and effective for their intended users;
|
•
|
the data from our clinical trials may be insufficient to support clearance or approval; and
|
•
|
failure of the manufacturing process or facilities we use to meet applicable requirements.
|
•
|
the federal healthcare programs’ Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering, paying or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, 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 or service for which payment may be made under federal healthcare programs such as the Medicare and state Medicaid programs;
|
•
|
federal and state false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, state Medicaid programs, or other third-party payors that are false or fraudulent;
|
•
|
federal and state physician referral laws, such as the Stark Law, that prohibit a physician from referring Medicare or Medicaid patients to an entity providing “designated health services,” including a company that furnishes durable medical equipment, with which the physician has a financial relationship unless that financial relationship meets an exception;
|
•
|
federal and state laws, such as the Civil Monetary Penalties Law, that prohibit an individual or entity from offering or transferring remuneration to any person eligible for benefits under a federal or state health care program which such individual or entity knows or should know are likely to influence such eligible individual’s choice of provider, practitioner or supplier of any item or service for which payment may be made under federal health care programs such as Medicare and state Medicaid programs;
|
•
|
federal criminal laws enacted as part of HIPAA that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
|
•
|
federal disclosure laws, such as the Physician Payments Sunshine Act, which require certain manufacturers, including medical device manufacturers, to submit annual data pertaining to payments or other transfers of value to covered recipients, including physicians;
|
•
|
the Federal Trade Commission Act and similar laws regulating advertisement and consumer protections;
|
•
|
foreign and 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; and
|
•
|
federal and state laws governing the use, disclosure and security of personal information, including protected health information, such as HIPAA and the Health Information Technology for Economic and Clinical Health.
|
•
|
actual or anticipated fluctuations in our financial and operating results from period to period;
|
•
|
our actual or perceived need for additional capital to fund our operations;
|
•
|
market acceptance of our current products and products under development, and the recognition of our brand;
|
•
|
introduction of proposed products, technologies or treatment techniques by us or our competitors;
|
•
|
announcements of significant contracts, acquisitions or divestitures by us or our competitors;
|
•
|
regulatory approval of our products or the products of our competitors, or the failure to obtain such approvals on the projected timeline or at all;
|
•
|
speculative trading practices of market participants;
|
•
|
issuance of securities analysts’ reports or recommendations;
|
•
|
threatened or actual litigation and government investigations;
|
•
|
sales of shares of our common stock by our employees, directors or principal stockholders; and
|
•
|
general political or economic conditions.
|
•
|
authorize the issuance of preferred stock with powers, preferences and rights that may be senior to our common stock, which can be created and issued by the board of directors without prior stockholder approval;
|
•
|
provide for the adoption of a staggered board of directors whereby the board is divided into three classes each of which has a different three-year term;
|
•
|
provide that the number of directors shall be fixed by the board;
|
•
|
prohibit our stockholders from filling board vacancies;
|
•
|
provide for the removal of a director only with cause and then by the affirmative vote of the holders of a majority of the outstanding shares;
|
•
|
prohibit stockholders from calling special stockholder meetings;
|
•
|
prohibit stockholders from acting by written consent without holding a meeting of stockholders;
|
•
|
require the vote of at least two-thirds of the outstanding shares to approve amendments to the certificate of incorporation or bylaws; and
|
•
|
require advance written notice of stockholder proposals and director nominations.
|
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
Item 3.
|
Defaults Upon Senior Securities
|
Item 4.
|
Mine Safety Disclosures
|
Item 5.
|
Other Information
|
Item 6.
|
Exhibits
|
|
Incorporated by Reference
|
|
Provided Herewith
|
|||
Exhibit Number
|
Exhibit Description
|
Form
|
File No.
|
Date of First Filing
|
Exhibit Number
|
|
31.1
|
|
|
|
|
X
|
|
31.2
|
|
|
|
|
X
|
|
32.1**
|
|
|
|
|
X
|
|
32.2**
|
|
|
|
|
X
|
|
101.INS
|
XBRL Instance Document.
|
|
|
|
|
X
|
101.SCH
|
XBRL Taxonomy Extension Schema Document.
|
|
|
|
|
X
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
|
|
|
|
X
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
|
|
|
|
X
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document.
|
|
|
|
|
X
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
|
|
|
|
X
|
104
|
Cover Page Interactive Data File (embedded within the Inline XBRL Document)
|
|
|
|
|
X
|
**
|
This certification is not deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of that section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except to the extent that the registrant specifically incorporates it by reference.
|
|
|
Tandem Diabetes Care, Inc.
|
|
|
|
|
|
Dated: November 4, 2019
|
|
By:
|
/s/ John F. Sheridan
|
|
|
|
John F. Sheridan
President and Chief Executive Officer
(on behalf of the registrant and as the registrant’s
Principal Executive Officer)
|
|
|
|
|
Dated: November 4, 2019
|
|
By:
|
/s/ Leigh A. Vosseller
|
|
|
|
Leigh A. Vosseller
Executive Vice President, Chief Financial Officer and Treasurer
(on behalf of the registrant and as the registrant’s
Principal Financial and Accounting Officer)
|
1 Year Tandem Diabetes Care Chart |
1 Month Tandem Diabetes Care Chart |
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